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query-laysum | 5254 | [
{
"role": "user",
"content": "Abstract: Background\nMorphea (morphoea) is an immune-mediated disease in which excess synthesis and deposition of collagen in the skin and underlying connective tissues results in hardened cutaneous areas. Morphea has different clinical features according to the subtype and stage of evolution of the disease. There is currently no consensus on optimal interventions for morphea.\nObjectives\nTo assess the effects of treatments for people with any form of morphea.\nSearch methods\nWe searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and five trial registers. We checked the reference lists of included studies for further references to relevant randomised controlled trials.\nSelection criteria\nRandomised controlled trials of topical, intralesional, or systemic treatments (isolated or combined) in anyone who has been clinically diagnosed by a medical practitioner with any form of morphea. Eligible controls were placebo, no intervention, any other treatment, or different doses or duration of a treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcomes were global improvement of disease activity or damage assessed by a medical practitioner or by participants, and adverse effects. Secondary outcomes were improvement of disease activity and improvement of disease damage. We used GRADE to assess the quality of the evidence for each outcome.\nMain results\nWe included 14 trials, with a total of 429 randomised participants, aged between 3 and 76 years. There were juvenile and adult participants; over half were female, and the majority had circumscribed morphea, followed by linear scleroderma. The settings of the studies (where described) included a dermatologic centre, a national laboratory centre, paediatric rheumatology and dermatology centres, and a university hospital or medical centre.\nThe studies evaluated heterogenous therapies for different types of morphea, covering a wide range of comparisons. We were unable to conduct any meta-analyses. Seven studies investigated topical medications, two evaluated intralesional medications, and five investigated systemic medications. The study duration ranged from seven weeks to 15 months from baseline.\nWe present here results for our primary outcomes for our four key comparisons. All of these results are based on low-quality evidence.\nThe included studies were at high risk of performance, detection, attrition, and reporting bias.\nGlobal improvement of disease activity or damage after treatment may be higher with oral methotrexate (15 mg/m², maximum 20 mg, once a week, for 12 months or until disease flare) plus oral prednisone (1 mg/kg a day, maximum of 50 mg, in a single morning dose, for three months, and one month with gradually decreased dose until discontinuation) than with placebo plus oral prednisone in children and adolescents with active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed) (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.20 to 4.45; number needed to treat for an additional beneficial outcome (NNTB) 3; 1 randomised controlled trial (RCT); 70 participants, all juvenile). This outcome was measured 12 months from the start of treatment or until flare of the disease. Data were not available separately for each morphea type. There may be little or no difference in the number of participants experiencing at least one adverse event with oral methotrexate (26/46) or placebo (11/24) (RR 1.23, 95% CI 0.75 to 2.04; 1 RCT; 70 participants assessed during the 12-month follow-up). Adverse events related to methotrexate included alopecia, nausea, headache, fatigue and hepatotoxicity, whilst adverse events related to prednisone (given in both groups) included weight gain (more than 5% of body weight) and striae rubrae.\nOne three-armed RCT compared the following treatments: medium-dose (50 J/cm²) UVA-1; low-dose (20 J/cm²) UVA-1; and narrowband UVB phototherapy. There may be little or no difference between treatments in global improvement of disease activity or damage, as assessed through the modified skin score (where high values represent a worse outcome): medium-dose UVA-1 phototherapy versus low-dose UVA-1 group: MD 1.60, 95% CI −1.70 to 4.90 (44 participants); narrowband UVB phototherapy versus medium-dose UVA-1 group: MD −1.70, 95% CI −5.27 to 1.87 (35 participants); and narrowband UVB versus low-dose UVA-1 group: MD −0.10, 95% CI −2.49 to 2.29 (45 participants). This RCT included children and adults with active morphea (circumscribed morphea, linear scleroderma (with trunk/limb variant and head variant), generalised morphea, or mixed morphea), who received phototherapy five times a week, for eight weeks. Outcomes were measured at eight weeks from the start of treatment.\nSafety data, measured throughout treatment, from the same RCT (62 participants) showed that treatment with UVA-1 phototherapy may cause mild tanning compared to narrowband UVB: narrowband UVB versus medium-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.42; 35 participants; narrowband UVB versus low-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.41; 45 participants. However, there may be no difference in the number of participants reporting mild tanning when comparing medium and low dose UVA-1 phototherapy (RR 1.00, 95% CI 0.91 to 1.10; 44 participants). Transient erythema was reported in three participants with narrowband UVB and no participants in the low- or medium-dose UVA-1 groups.\nAuthors' conclusions\nCompared to placebo plus oral prednisone, oral methotrexate plus oral prednisone may improve disease activity or damage in juvenile active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed), but there may be a slightly increased chance of experiencing at least one adverse event.\nWhen medium-dose UVA-1 (50 J/cm²), low-dose UVA-1 (20 J/cm²), and narrowband UVB were compared against each other in treating children and adults with active morphea (circumscribed morphea, linear scleroderma, generalised morphea and mixed morphea), there may be little or no difference between these treatments on global improvement of disease activity or damage. UVA-1 phototherapy may cause more mild tanning than narrowband UVB, but there may be no difference between medium- and low-dose UVA-1 phototherapy. These results are based on low-quality evidence.\nLimitations of data and analyses include risk of bias and imprecision (small number of participants or events and wide confidence intervals). We encourage multicentre RCTs to increase sample size and evaluate, with validated tools, different treatment responses according to the subtypes of morphea and age groups.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Morphea is a rare disease that causes skin hardening. It affects adults and children equally, and is more common in females. There are different subtypes of morphea, with different characteristics: circumscribed morphea is generally less severe than the other subtypes; linear scleroderma can cause significant body differences, possibly affecting growth in children; generalised morphea is a severe type involving multiple areas of the body; pansclerotic morphea is a severe and progressive type of generalised morphea; and mixed morphea is the presence of two or more disease types. Recurrence rates are high, and even when disease activity reduces, a person can be left with permanent effects. This review intended to assess the safety and effectiveness of different treatments for morphea."
}
]
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query-laysum | 5255 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is one of the most common morbidities of the postnatal period. It has been associated with adverse outcomes for women, children, the wider family and society as a whole. Treatment is with psychosocial interventions or antidepressant medication, or both. The aim of this review is to evaluate the effectiveness of different antidepressants and to compare their effectiveness with placebo, treatment as usual or other forms of treatment. This is an update of a review last published in 2014.\nObjectives\nTo assess the effectiveness and safety of antidepressant drugs in comparison with any other treatment (psychological, psychosocial, or pharmacological), placebo, or treatment as usual for postnatal depression.\nSearch methods\nWe searched Cochrane Common Mental Disorders's Specialized Register, CENTRAL, MEDLINE, Embase and PsycINFO in May 2020. We also searched international trials registries and contacted experts in the field.\nSelection criteria\nWe included randomised controlled trials (RCTs) of women with depression during the first 12 months postpartum that compared antidepressant treatment (alone or in combination with another treatment) with any other treatment, placebo or treatment as usual.\nData collection and analysis\nTwo review authors independently extracted data from the study reports. We requested missing information from study authors wherever possible. We sought data to allow an intention-to-treat analysis. Where we identified sufficient comparable studies we pooled data and conducted random-effects meta-analyses.\nMain results\nWe identified 11 RCTs (1016 women), the majority of which were from English-speaking, high-income countries; two were from middle-income countries. Women were recruited from a mix of community-based, primary care, maternity and outpatient settings. Most studies used selective serotonin reuptake inhibitors (SSRIs), with treatment duration ranging from 4 to 12 weeks.\nMeta-analysis showed that there may be a benefit of SSRIs over placebo in response (55% versus 43%; pooled risk ratio (RR) 1.27, 95% confidence interval (CI) 0.97 to 1.66); remission (42% versus 27%; RR 1.54, 95% CI 0.99 to 2.41); and reduced depressive symptoms (standardised mean difference (SMD) −0.30, 95% CI −0.55 to −0.05; 4 studies, 251 women), at 5 to 12 weeks' follow-up. We were unable to conduct meta-analysis for adverse events due to variation in the reporting of this between studies. There was no evidence of a difference between acceptability of SSRI and placebo (27% versus 27%; RR 1.10, 95% CI 0.74 to 1.64; 4 studies; 233 women). The certainty of all the evidence for SSRIs was low or very low due to the small number of included studies and a number of potential sources of bias, including high rates of attrition.\nThere was insufficient evidence to assess the efficacy of SSRIs compared with other classes of antidepressants and of antidepressants compared with other pharmacological interventions, complementary medicines, psychological and psychosocial interventions or treatment as usual. A substantial proportion of women experienced adverse effects but there was no evidence of differences in the number of adverse effects between treatment groups in any of the studies. Data on effects on children, including breastfed infants, parenting, and the wider family were limited, although no adverse effects were noted.\nAuthors' conclusions\nThere remains limited evidence regarding the effectiveness and safety of antidepressants in the management of postnatal depression, particularly for those with more severe depression. We found low-certainty evidence that SSRI antidepressants may be more effective in treating postnatal depression than placebo as measured by response and remission rates. However, the low certainty of the evidence suggests that further research is very likely to have an important impact on our effect estimate. There is a continued imperative to better understand whether, and for whom, antidepressants or other treatments are more effective for postnatal depression, and whether some antidepressants are more effective or better tolerated than others.\nIn clinical practice, the findings of this review need to be contextualised by the extensive broader literature on antidepressants in the general population and perinatal clinical guidance, to inform an individualised risk-benefit clinical decision. Future RCTs should focus on larger samples, longer follow-up, comparisons with alternative treatment modalities and inclusion of child and parenting outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this Cochrane Review, we wanted to find out how well antidepressants work for treating women with postnatal depression."
}
]
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query-laysum | 5256 | [
{
"role": "user",
"content": "Abstract: Background\nThe anaemia seen in chronic kidney disease (CKD) may be exacerbated by iron deficiency. Iron can be provided through different routes, with advantages and drawbacks of each route. It remains unclear whether the potential harms and additional costs of intravenous (IV) compared with oral iron are justified. This is an update of a review first published in 2012.\nObjectives\nTo determine the benefits and harms of IV iron supplementation compared with oral iron for anaemia in adults and children with CKD, including participants on dialysis, with kidney transplants and CKD not requiring dialysis.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 7 December 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in which IV and oral routes of iron administration were compared in adults and children with CKD.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, and extracted data. Results were reported as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes the mean difference (MD) was used or standardised mean difference (SMD) if different scales had been used. Statistical analyses were performed using the random-effects model. Subgroup analysis and univariate meta-regression were performed to investigate between study differences. The certainty of the evidence was assessed using GRADE.\nMain results\nWe included 39 studies (3852 participants), 11 of which were added in this update. A low risk of bias was attributed to 20 (51%) studies for sequence generation, 14 (36%) studies for allocation concealment, 22 (56%) studies for attrition bias and 20 (51%) for selective outcome reporting. All studies were at a high risk of performance bias. However, all studies were considered at low risk of detection bias because the primary outcome in all studies was laboratory-based and unlikely to be influenced by lack of blinding.\nThere is insufficient evidence to suggest that IV iron compared with oral iron makes any difference to death (all causes) (11 studies, 1952 participants: RR 1.12, 95% CI 0.64, 1.94) (absolute effect: 33 participants per 1000 with IV iron versus 31 per 1000 with oral iron), the number of participants needing to start dialysis (4 studies, 743 participants: RR 0.81, 95% CI 0.41, 1.61) or the number needing blood transfusions (5 studies, 774 participants: RR 0.86, 95% CI 0.55, 1.34) (absolute effect: 87 per 1,000 with IV iron versus 101 per 1,000 with oral iron). These analyses were assessed as having low certainty evidence. It is uncertain whether IV iron compared with oral iron reduces cardiovascular death because the certainty of this evidence was very low (3 studies, 206 participants: RR 1.71, 95% CI 0.41 to 7.18). Quality of life was reported in five studies with four reporting no difference between treatment groups and one reporting improvement in participants treated with IV iron.\nIV iron compared with oral iron may increase the numbers of participants, who experience allergic reactions or hypotension (15 studies, 2607 participants: RR 3.56, 95% CI 1.88 to 6.74) (absolute harm: 24 per 1000 with IV iron versus 7 per 1000) but may reduce the number of participants with all gastrointestinal adverse effects (14 studies, 1986 participants: RR 0.47, 95% CI 0.33 to 0.66) (absolute benefit: 150 per 1000 with IV iron versus 319 per 1000). These analyses were assessed as having low certainty evidence.\nIV iron compared with oral iron may increase the number of participants who achieve target haemoglobin (13 studies, 2206 participants: RR 1.71, 95% CI 1.43 to 2.04) (absolute benefit: 542 participants per 1,000 with IV iron versus 317 per 1000 with oral iron), increased haemoglobin (31 studies, 3373 participants: MD 0.72 g/dL, 95% CI 0.39 to 1.05); ferritin (33 studies, 3389 participants: MD 224.84 µg/L, 95% CI 165.85 to 283.83) and transferrin saturation (27 studies, 3089 participants: MD 7.69%, 95% CI 5.10 to 10.28), and may reduce the dose required of erythropoietin-stimulating agents (ESAs) (11 studies, 522 participants: SMD -0.72, 95% CI -1.12 to -0.31) while making little or no difference to glomerular filtration rate (8 studies, 1052 participants: 0.83 mL/min, 95% CI -0.79 to 2.44). All analyses were assessed as having low certainty evidence. There were moderate to high degrees of heterogeneity in these analyses but in meta-regression, definite reasons for this could not be determined.\nAuthors' conclusions\nThe included studies provide low certainty evidence that IV iron compared with oral iron increases haemoglobin, ferritin and transferrin levels in CKD participants, increases the number of participants who achieve target haemoglobin and reduces ESA requirements. However, there is insufficient evidence to determine whether IV iron compared with oral iron influences death (all causes), cardiovascular death and quality of life though most studies reported only short periods of follow-up. Adverse effects were reported in only 50% of included studies. We therefore suggest that further studies that focus on patient-centred outcomes with longer follow-up periods are needed to determine if the use of IV iron is justified on the basis of reductions in ESA dose and cost, improvements in patient quality of life, and with few serious adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Although the results suggest that IV iron compared with oral iron may be more effective in raising iron and haemoglobin levels, we found insufficient data to determine if the benefits of IV iron are justified by improved quality of life or mortality despite the small risk of potentially serious allergic effects in some patients given IV iron."
}
]
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query-laysum | 5257 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in Issue 10, 2014. There is a need to expand monotherapy options available to a clinician for the treatment of new focal or generalized seizures. A Cochrane systematic review for clobazam monotherapy is expected to define its place in the treatment of new-onset or untreated seizures and highlight gaps in evidence.\nObjectives\nTo evaluate the efficacy, effectiveness, tolerability and safety of clobazam as monotherapy in people with new-onset focal or generalized seizures.\nSearch methods\nFor the latest update we searched the following databases on 19 March 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946- ), BIOSIS Previews (1969- ), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP). There were no language restrictions.\nSelection criteria\nRandomized or quasi-randomized controlled trials comparing clobazam monotherapy versus placebo or other anti-seizure medication in people with two or more unprovoked seizures or single acute symptomatic seizure requiring short-term continuous anti-seizure medication, were eligible for inclusion.\nData collection and analysis\nPrimary outcome measure was time on allocated treatment (retention time), reflecting both efficacy and tolerability. Secondary outcomes included short- and long-term effectiveness measures, tolerability, quality of life, and tolerance measures. Two authors independently extracted the data.\nMain results\nWe identified three trials fulfilling the review criteria, which included 206 participants. None of the identified studies reported the preselected primary outcome measure. A meta-analysis was not possible. Lack of detail regarding allocation concealment and a high risk of performance and detection bias in two studies prompted us to downgrade the quality of evidence (by using the GRADE approach) for some of our results due to risk of bias.\nRegarding retention at 12 months, we detected no evidence of a statistically significant difference between clobazam and carbamazepine (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.61 to 1.12; low-quality evidence). There was low-quality evidence that clobazam led to better retention compared with phenytoin (RR 1.43, 95% CI 1.08 to 1.90). We could not determine whether participants receiving clobazam were found to be less likely to discontinue it due to adverse effects as compared to phenytoin (RR 0.10, 95% CI 0.01 to 1.65, low-quality evidence).\nAuthors' conclusions\nWe found no advantage for clobazam over carbamazepine for retention at 12 months in drug-naive children and a slight advantage of clobazam over phenytoin for retention at six months in adolescents and adults with neurocysticercosis in a single clinical trial each. At present, the available evidence is insufficient to inform clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No significant advantage of clobazam over carbamazepine in people with previously untreated focal or generalized seizures was seen for retention at 12 months. A slight advantage of clobazam over phenytoin for retention at six months was noted in one study, which was limited to participants having seizures due to neurocysticercosis. No significant differences in proportion of BCECTS participants who achieved seizure freedom at four weeks, between four and 40 weeks, and during the last nine months of treatment between clobazam and carbamazepine were found. Also, no significant difference in the proportion of participants who achieved a 50% or greater reduction in their seizures at four weeks on clobazam versus carbamazepine was noted. However, participants randomized to clobazam achieved seizure control sooner than those treated with carbamazepine.\nNone of the studies measured the amount of time that participants remained on allocated treatment (retention time), or quality of life. We did assess data from the studies regarding the number of participants who remained on treatment at specific time points. However, we were unable to determine whether people with previously untreated focal or generalized seizures receiving clobazam were more likely to remain on treatment at 12 months than those given carbamazepine due to low numbers of participants in the study. One of the studies showed that social and academic outcomes improved in participants taking clobazam as well as carbamazepine; however, there was no comparative analysis."
}
]
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query-laysum | 5258 | [
{
"role": "user",
"content": "Abstract: Background\nInfluenza is an acute respiratory illness caused by influenza A and B viruses. Complications may occur, especially among children and the elderly.\nObjectives\nTo assess the effectiveness and safety of amantadine and rimantadine in preventing, treating and shortening the duration of influenza A in children and the elderly.\nSearch methods\nWe searched CENTRAL (2014, Issue 9), MEDLINE (1966 to September week 4, 2014) and EMBASE (1980 to October 2014).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing amantadine and/or rimantadine with no intervention, placebo, other antivirals or different doses or schedules of amantadine or rimantadine in children and the elderly with influenza A.\nData collection and analysis\nTwo review authors independently assessed the search results. We extracted and analysed data using the standard Cochrane methodology.\nMain results\nWe identified 12 studies (2494 participants: 1586 children and 908 elderly) comparing amantadine and rimantadine with placebo, paracetamol (one trial: 69 children) or zanamivir (two trials: 545 elderly) to treat influenza A.\nAmantadine was effective in preventing influenza A in children (773 participants, risk ratio (RR) 0.11; 95% confidence interval (CI) 0.04 to 0.30). The assumed risk of influenza A in the control group was 10 per 100. The corresponding risk in the rimantadine group was one per 100 (95% CI 0 to 3). Nevertheless, the quality of the evidence was low and the safety of the drug was not well established.\nFor treatment, rimantadine was beneficial in abating fever on day three of treatment in children: one selected study with low risk of bias, moderate evidence quality and 69 participants (RR 0.36; 95% CI 0.14 to 0.91). The assumed risk was 38 per 100. The corresponding risk in the rimantadine group was 14 per 100 (95% CI 5 to 34).\nRimantadine did not show any prophylactic effect in the elderly. The quality of evidence was very low: 103 participants (RR 0.45; 95% CI 0.14 to 1.41). The assumed risk was 17 per 100. The corresponding risk in the rimantadine group was 7 per 100 (95% CI 2 to 23).\nThere was no evidence of adverse effects caused by treatment with amantadine or rimantadine.\nWe found no studies assessing amantadine in the elderly.\nAuthors' conclusions\nThe quality of the evidence combined with a lack of knowledge about the safety of amantadine and the limited benefits of rimantadine, do not indicate that amantadine and rimantadine compared to control (placebo or paracetamol) could be useful in preventing, treating and shortening the duration of influenza A in children and the elderly.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "As recommended by the World Health Organization (WHO), oseltamivir (Tamiflu) is currently used for people with influenza A. In previous pandemics, the virus was susceptible to amantadine and rimantadine. If they are safe and the circulating strain proves to be susceptible to these drugs, they could be an alternative for managing influenza. We therefore wanted to answer the question of whether or not amantadine and rimantadine can prevent and treat influenza A in children and the elderly."
}
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query-laysum | 5259 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative pancreatic fistula is a common and serious complication following pancreaticoduodenectomy. Duct-to-mucosa pancreaticojejunostomy has been used in many centers to reconstruct pancreatic digestive continuity following pancreatoduodenectomy, however, its efficacy and safety are uncertain.\nObjectives\nTo assess the benefits and harms of duct-to-mucosa pancreaticojejunostomy versus other types of pancreaticojejunostomy for the reconstruction of pancreatic digestive continuity in participants undergoing pancreaticoduodenectomy, and to compare the effects of different duct-to-mucosa pancreaticojejunostomy techniques.\nSearch methods\nWe searched the Cochrane Library (2021, Issue 1), MEDLINE (1966 to 9 January 2021), Embase (1988 to 9 January 2021), and Science Citation Index Expanded (1982 to 9 January 2021).\nSelection criteria\nWe included all randomized controlled trials (RCTs) that compared duct-to-mucosa pancreaticojejunostomy with other types of pancreaticojejunostomy (e.g. invagination pancreaticojejunostomy, binding pancreaticojejunostomy) in participants undergoing pancreaticoduodenectomy. We also included RCTs that compared different types of duct-to-mucosa pancreaticojejunostomy in participants undergoing pancreaticoduodenectomy.\nData collection and analysis\nTwo review authors independently identified the studies for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CIs). For all analyses, we used the random-effects model. We used the Cochrane RoB 1 tool to assess the risk of bias. We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nWe included 11 RCTs involving a total of 1696 participants in the review. One RCT was a dual-center study; the other 10 RCTs were single-center studies conducted in: China (4 studies); Japan (2 studies); USA (1 study); Egypt (1 study); Germany (1 study); India (1 study); and Italy (1 study). The mean age of participants ranged from 54 to 68 years. All RCTs were at high risk of bias.\nDuct-to-mucosa versus any other type of pancreaticojejunostomy\nWe included 10 RCTs involving 1472 participants comparing duct-to-mucosa pancreaticojejunostomy with invagination pancreaticojejunostomy: 732 participants were randomized to the duct-to-mucosa group, and 740 participants were randomized to the invagination group after pancreaticoduodenectomy. Comparing the two techniques, the evidence is very uncertain for the rate of postoperative pancreatic fistula (grade B or C; RR 1.45, 95% CI 0.64 to 3.26; 7 studies, 1122 participants; very low-certainty evidence), postoperative mortality (RR 0.77, 95% CI 0.39 to 1.49; 10 studies, 1472 participants; very low-certainty evidence), rate of surgical reintervention (RR 1.12, 95% CI 0.65 to 1.95; 10 studies, 1472 participants; very low-certainty evidence), rate of postoperative bleeding (RR 0.85, 95% CI 0.51 to 1.42; 9 studies, 1275 participants; very low-certainty evidence), overall rate of surgical complications (RR 1.12, 95% CI 0.92 to 1.36; 5 studies, 750 participants; very low-certainty evidence), and length of hospital stay (MD -0.41 days, 95% CI -1.87 to 1.04; 4 studies, 658 participants; very low-certainty evidence). The studies did not report adverse events or quality of life outcomes.\nOne type of duct-to-mucosa pancreaticojejunostomy versus a different type of duct-to-mucosa pancreaticojejunostomy\nWe included one RCT involving 224 participants comparing duct-to-mucosa pancreaticojejunostomy using the modified Blumgart technique with duct-to-mucosa pancreaticojejunostomy using the traditional interrupted technique: 112 participants were randomized to the modified Blumgart group, and 112 participants were randomized to the traditional interrupted group after pancreaticoduodenectomy. Comparing the two techniques, the evidence is very uncertain for the rate of postoperative pancreatic fistula (grade B or C; RR 1.51, 95% CI 0.61 to 3.75; 1 study, 210 participants; very low-certainty evidence), postoperative mortality (there were no deaths in either group; 1 study, 210 participants; very low-certainty evidence), rate of surgical reintervention (RR 1.93, 95% CI 0.18 to 20.91; 1 study, 210 participants; very low-certainty evidence), rate of postoperative bleeding (RR 2.89, 95% CI 0.12 to 70.11; 1 study, 210 participants; very low-certainty evidence), overall rate of surgical complications (RR 1.10, 95% CI 0.80 to 1.51; 1 study, 210 participants; very low-certainty evidence), and length of hospital stay (15 days versus 15 days; 1 study, 210 participants; very low-certainty evidence). The study did not report adverse events or quality of life outcomes.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of duct-to-mucosa pancreaticojejunostomy compared to invagination pancreaticojejunostomy on any of the outcomes, including rate of postoperative pancreatic fistula (grade B or C), postoperative mortality, rate of surgical reintervention, rate of postoperative bleeding, overall rate of surgical complications, and length of hospital stay. The evidence is also very uncertain whether duct-to-mucosa pancreaticojejunostomy using the modified Blumgart technique is superior, equivalent or inferior to duct-to-mucosa pancreaticojejunostomy using the traditional interrupted technique. None of the studies reported adverse events or quality of life outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared:\n- duct-to-mucosa pancreaticojejunostomy against any other type of pancreaticojejunostomy; or\n- different types of duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy.\nWe compared and summarized the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 5260 | [
{
"role": "user",
"content": "Abstract: Background\nConversion and dissociative disorders are conditions where people experience unusual neurological symptoms or changes in awareness or identity. However, symptoms and clinical signs cannot be explained by a neurological disease or other medical condition. Instead, a psychological stressor or trauma is often present. The symptoms are real and can cause significant distress or problems with functioning in everyday life for the people experiencing them.\nObjectives\nTo assess the beneficial and harmful effects of psychosocial interventions of conversion and dissociative disorders in adults.\nSearch methods\nWe conducted database searches between 16 July and 16 August 2019. We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and eight other databases, together with reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nWe included all randomised controlled trials that compared psychosocial interventions for conversion and dissociative disorders with standard care, wait list or other interventions (pharmaceutical, somatic or psychosocial).\nData collection and analysis\nWe selected, quality assessed and extracted data from the identified studies. Two review authors independently performed all tasks. We used standard Cochrane methodology. For continuous data, we calculated mean differences (MD) and standardised mean differences (SMD) with 95% confidence interval (CI). For dichotomous outcomes, we calculated risk ratio (RR) with 95% CI. We assessed and downgraded the evidence according to the GRADE system for risk of bias, imprecision, indirectness, inconsistency and publication bias.\nMain results\nWe included 17 studies (16 with parallel-group designs and one with a cross-over design), with 894 participants aged 18 to 80 years (female:male ratio 3:1).\nThe data were separated into 12 comparisons based on the different interventions and comparators. Studies were pooled into the same comparison when identical interventions and comparisons were evaluated. The certainty of the evidence was downgraded as a consequence of potential risk of bias, as many of the studies had unclear or inadequate allocation concealment. Further downgrading was performed due to imprecision, few participants and inconsistency.\nThere were 12 comparisons for the primary outcome of reduction in physical signs.\nInpatient paradoxical intention therapy compared with outpatient diazepam: inpatient paradoxical intention therapy did not reduce conversive symptoms compared with outpatient diazepam at the end of treatment (RR 1.44, 95% CI 0.91 to 2.28; 1 study, 30 participants; P = 0.12; very low-quality evidence).\nInpatient treatment programme plus hypnosis compared with inpatient treatment programme: inpatient treatment programme plus hypnosis did not reduce severity of impairment compared with inpatient treatment programme at the end of treatment (MD –0.49 (negative value better), 95% CI –1.28 to 0.30; 1 study, 45 participants; P = 0.23; very low-quality evidence).\nOutpatient hypnosis compared with wait list: outpatient hypnosis might reduce severity of impairment compared with wait list at the end of treatment (MD 2.10 (higher value better), 95% CI 1.34 to 2.86; 1 study, 49 participants; P < 0.00001; low-quality evidence).\nBehavioural therapy plus routine clinical care compared with routine clinical care: behavioural therapy plus routine clinical care might reduce the number of weekly seizures compared with routine clinical care alone at the end of treatment (MD –21.40 (negative value better), 95% CI –27.88 to –14.92; 1 study, 18 participants; P < 0.00001; very low-quality evidence).\nCognitive behavioural therapy (CBT) compared with standard medical care: CBT did not reduce monthly seizure frequency compared to standard medical care at end of treatment (RR 1.56, 95% CI 0.39 to 6.19; 1 study, 16 participants; P = 0.53; very low-quality evidence). CBT did not reduce physical signs compared to standard medical care at the end of treatment (MD –4.75 (negative value better), 95% CI –18.73 to 9.23; 1 study, 61 participants; P = 0.51; low-quality evidence). CBT did not reduce seizure freedom compared to standard medical care at end of treatment (RR 2.33, 95% CI 0.30 to 17.88; 1 trial, 16 participants; P = 0.41; very low-quality evidence).\nPsychoeducational follow-up programmes compared with treatment as usual (TAU): no study measured reduction in physical signs at end of treatment.\nSpecialised CBT-based physiotherapy inpatient programme compared with wait list: no study measured reduction in physical signs at end of treatment.\nSpecialised CBT-based physiotherapy outpatient intervention compared with TAU: no study measured reduction in physical signs at end of treatment.\nBrief psychotherapeutic intervention (psychodynamic interpersonal treatment approach) compared with standard care: brief psychotherapeutic interventions did not reduce conversion symptoms compared to standard care at end of treatment (RR 0.12, 95% CI 0.01 to 2.00; 1 study, 19 participants; P = 0.14; very low-quality evidence).\nCBT plus adjunctive physical activity (APA) compared with CBT alone: CBT plus APA did not reduce overall physical impacts compared to CBT alone at end of treatment (MD 5.60 (negative value better), 95% CI –15.48 to 26.68; 1 study, 21 participants; P = 0.60; very low-quality evidence).\nHypnosis compared to diazepam: hypnosis did not reduce symptoms compared to diazepam at end of treatment (RR 0.69, 95% CI 0.39 to 1.24; 1 study, 40 participants; P = 0.22; very low-quality evidence).\nOutpatient motivational interviewing (MI) and mindfulness-based psychotherapy compared with psychotherapy alone: psychotherapy preceded by MI might decrease seizure frequency compared with psychotherapy alone at end of treatment (MD 41.40 (negative value better), 95% CI 4.92 to 77.88; 1 study, 54 participants; P = 0.03; very low-quality evidence).\nThe effect on the secondary outcomes was reported in 16/17 studies. None of the studies reported results on adverse effects. In the studies reporting on level of functioning and quality of life at end of treatment the effects ranged from small to no effect.\nAuthors' conclusions\nThe results of the meta-analysis and reporting of single studies suggest there is lack of evidence regarding the effects of any psychosocial intervention on conversion and dissociative disorders in adults. It is not possible to draw any conclusions about potential benefits or harms from the included studies.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We investigated the effect of different types of psychosocial interventions, ranging from hypnosis to behavioural therapy. None of the studies were conducted to a high enough standard to be able to say anything conclusive about the evidence of the results.\nThere was a reduction in physical signs at the end of treatment for three interventions.\nHypnosis reduced the severity of impairment compared to people on a wait list for treatment; behavioural therapy, given on top of routine care to inpatients, reduced the number of weekly seizures (fits) and symptom severity compared with people receiving routine care alone; and psychotherapy preceded by motivational interviewing (a talking therapy that attempts to move an person away from a state of indecision or uncertainty to positivity) compared with psychotherapy alone reduced seizure frequency."
}
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query-laysum | 5261 | [
{
"role": "user",
"content": "Abstract: Background\nFractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015.\nObjectives\nTo assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.\nData collection and analysis\nPairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison.\nMain results\nWe included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below.\nEarly (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures\nFive trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment.\nSurgical versus non-surgical treatment\nTen trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants).\nOpen reduction and internal fixation with a locking plate versus a locking intramedullary nail\nFour trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants).\nReverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty\nThere is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence).\nAuthors' conclusions\nThere is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures.\nThere is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.\n\nGiven the provided abstract, please respond to the following query: \"1. Is it better to move the shoulder within a week of fracture or delay movement for three or more weeks?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to limited evidence from five non-surgical studies, we are unsure whether early movement of the arm improves or makes no difference to long-term shoulder function or the development of shoulder problems."
}
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query-laysum | 5262 | [
{
"role": "user",
"content": "Abstract: Background\nScreening for malignant melanoma has the potential to reduce morbidity and mortality from the disease through earlier detection, as prognosis is closely associated with the thickness of the lesion at the time of diagnosis. However, there are also potential harms from screening people without skin lesion concerns, such as overdiagnosis of lesions that would never have caused symptoms if they had remained undetected. Overdiagnosis results in harm through unnecessary treatment and the psychosocial consequences of being labelled with a cancer diagnosis. For any type of screening, the benefits must outweigh the harms. Screening for malignant melanoma is currently practised in many countries, and the incidence of the disease is rising sharply, while mortality remains largely unchanged.\nObjectives\nTo assess the effects on morbidity and mortality of screening for malignant melanoma in the general population.\nSearch methods\nWe searched the following databases up to May 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registries, checked the reference lists of included and other relevant studies for further references to randomised controlled trials (RCTs), used citation tracking (Web of Science) for key articles, and asked trialists about additional studies and study reports.\nSelection criteria\nRCTs, including cluster-randomised trials, of screening for malignant melanoma compared with no screening, regardless of screening modality or setting, in any type of population and in any age group where people were not suspected of having malignant melanoma. We excluded studies in people with a genetic disposition for malignant melanoma (e.g. familial atypical mole and melanoma syndrome) and studies performed exclusively in people with previous melanomas.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcomes of this review were total mortality, overdiagnosis of malignant melanoma, and quality of life/psychosocial consequences.\nMain results\nWe included two studies with 64,391 participants. The first study was a randomised trial of an intervention developed to increase the rate of performance of thorough skin self-examination. The intervention group received instructional materials, including cues and aids, a 14-minute instruction video, and a brief counselling session, and at three weeks a brief follow-up telephone call from a health educator, aimed at increasing performance of thorough skin self-examination. The control group received a diet intervention with similar follow-up. The trial included 1356 people, who were recruited from 11 primary care practices in the US between 2000 and 2001. Participant mean age was 53.2 years and 41.7% were men. This study did not report on any of our primary outcomes or the following secondary outcomes: mortality specific to malignant melanoma, false-positive rates (skin biopsies/excisions with benign outcome), or false-negative rates (malignant melanomas diagnosed between screening rounds and up to one year after the last round). All participants were asked to complete follow-up telephone interviews at 2, 6, and 12 months after randomisation.\nThe second study was a pilot study for a cluster-RCT of population-based screening for malignant melanoma in Australia. This pilot trial included 63,035 adults aged over 30 years. The three-year programme involved community education, an education and support component for medical practitioners, and the provision of free skin screening services. The mean age of people attending the skin screening clinics (which were held by primary care physicians in workplaces, community venues, and local hospitals, and included day and evening sessions) was 46.5 years, and 51.5% were men. The study included whole communities, targeting participants over 30 years of age, but information on age and gender of the whole study population was not reported. Study duration was three years (1998 to 2001), and outcomes were measured at the screening clinics during these three years. There was no further follow-up for any outcomes. The control group received no programme. The ensuing, planned cluster randomised trial in 560,000 adults was never carried out due to lack of funding. At the time of this review, there are no published or unpublished data on our prespecified outcomes available, and no results for mortality outcomes from the pilot study are to be expected.\nThe risk of bias in these studies was high for performance bias (blinding study personnel and participants) and high or unclear for detection bias (blinding of outcome assessment). Risk of bias in the other domains was either unclear or low. We were unable to assess the certainty of the evidence for our primary outcomes as planned due to lack of data.\nAuthors' conclusions\nAdult general population screening for malignant melanoma is not supported or refuted by current evidence from RCTs. It therefore does not fulfil accepted criteria for implementation of population screening programmes. This review did not investigate the effects of screening people with a history of malignant melanoma or in people with a genetic disposition for malignant melanoma (e.g. familial atypical mole and melanoma syndrome). To determine the benefits and harms of screening for malignant melanoma, a rigorously conducted randomised trial is needed, which assesses overall mortality, overdiagnosis, psychosocial consequences, and resource use.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was no information from either study on the effects of screening on total deaths, overdiagnosis from screening, or participant quality of life. The following outcomes were also not reported: deaths from skin cancer and false-positive/-negative rates (i.e. diagnosing a skin lesion as a melanoma when it is not present/not recognising a melanoma when it is present). Thus, we do not know whether screening for malignant melanoma results in any benefit, or whether such a possible benefit would be outweighed by harms of screening. General adult population screening for malignant melanoma is not supported or refuted by evidence from well-designed trials up to May 2018 and therefore does not fulfil accepted criteria for implementing screening programmes."
}
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query-laysum | 5263 | [
{
"role": "user",
"content": "Abstract: Background\nEvidence suggests that many perimenopausal and early postmenopausal women will experience menopausal symptoms; hot flushes are the most common. Symptoms caused by fluctuating levels of oestrogen may be alleviated by hormone therapy (HT), but a marked global decline in its use has resulted from concerns about the risks and benefits of HT. Consequently, many women are seeking alternatives. As large numbers of women are choosing not to take HT, it is increasingly important to identify evidence-based lifestyle modifications that have the potential to reduce vasomotor menopausal symptoms.\nObjectives\nTo examine the effectiveness of any type of exercise intervention in the management of vasomotor symptoms in symptomatic perimenopausal and postmenopausal women.\nSearch methods\nSearches of the following electronic bibliographic databases were performed to identify randomised controlled trials (RCTs): Cochrane Menstrual Disorders and Subfertility Group Specialised Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Wiley Internet interface), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), the Science Citation Index and the Social Science Citation Index (Web of Science), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (Ovid) and SPORTDiscus. Searches include findings up to 3 March 2014.\nSelection criteria\nRCTs in which any type of exercise intervention was compared with no treatment/control or other treatments in the management of menopausal vasomotor symptoms in symptomatic perimenopausal/postmenopausal women.\nData collection and analysis\nFive studies were deemed eligible for inclusion. Two review authors independently selected the studies, and three review authors independently extracted the data. The primary review outcome was vasomotor symptoms, defined as hot flushes and/or night sweats. We combined data to calculate standardised mean differences (SMDs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I2 statistic. We assessed the overall quality of the evidence for main comparisons using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.\nMain results\nWe included five RCTs (733 women) comparing exercise with no active treatment, exercise with yoga and exercise with HT. The evidence was of low quality: Limitations in study design were noted, along with inconsistency and imprecision. In the comparison of exercise versus no active treatment (three studies, n = 454 women), no evidence was found of a difference between groups in frequency or intensity of vasomotor symptoms (SMD -0.10, 95% CI -0.33 to 0.13, three RCTs, 454 women, I2 = 30%, low-quality evidence). Nor was any evidence found of a difference between groups in the frequency or intensity of vasomotor symptoms when exercise was compared with yoga (SMD -0.03, 95% CI -0.45 to 0.38, two studies, n = 279 women, I2 = 61%, low-quality evidence). It was not possible to include one of the trials in the meta-analyses; this trial compared three groups: exercise plus soy milk, soy milk only and control; results favoured exercise relative to the comparators, but study numbers were small. One trial compared exercise with HT, and the HT group reported significantly fewer flushes in 24 hours than the exercise group (mean difference 5.8, 95% CI 3.17 to 8.43, 14 participants). None of the trials found evidence of a difference between groups with respect to adverse effects, but data were very scanty.\nAuthors' conclusions\nEvidence was insufficient to show whether exercise is an effective treatment for vasomotor menopausal symptoms. One small study suggested that HT is more effective than exercise. Evidence was insufficient to show the relative effectiveness of exercise when compared with HT or yoga.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Five studies randomly assigned 762 women experiencing hot flushes/night sweats. Three trials and two trials, respectively, were included in pooled comparisons of exercise versus control (n = 454 women) and exercise versus yoga (n = 279 women). One small study (14 women) compared exercise versus hormone therapy."
}
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query-laysum | 5264 | [
{
"role": "user",
"content": "Abstract: Background\nSemen preparation techniques for assisted reproduction, including intrauterine insemination (IUI), were developed to select the motile morphologically normal spermatozoa. The yield of many motile, morphologically normal spermatozoa might influence treatment choices and therefore outcomes.\nObjectives\nTo compare the effectiveness of three different semen preparation techniques (gradient; swim-up; wash and centrifugation) on clinical outcomes (live birth rate; clinical pregnancy rate) in subfertile couples undergoing IUI.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group (CGFG) trials register, CENTRAL, MEDLINE, Embase, Science Direct Database, National Research Register, Biological Abstracts and clinical trial registries in March 2019, and checked references and contacted study authors to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the efficacy in terms of clinical outcomes of semen preparation techniques used for subfertile couples undergoing IUI.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes are live birth rate and clinical pregnancy rate per couple.\nMain results\nWe included seven RCTS in the review; we included six of these, totalling 485 couples, in the meta-analysis. No trials reported the primary outcome of live birth. The evidence was of very low-quality. The main limitations were (unclear) risk of bias, signs of imprecision and inconsistency in results among studies and the small number of studies/participants included.\nSwim-up versus gradient technique\nConsidering the quality of evidence, we are uncertain whether there was a difference between clinical pregnancy rates (CPR) for swim-up versus a gradient technique (odds ratio (OR) 0.83, 95% CI 0.51 to 1.35; I² = 71%; 4 RCTs, 370 participants; very low-quality evidence). The results suggest that if the chance of pregnancy after the use of a gradient technique is assumed to be 24%, the chance of pregnancy after using the swim-up technique is between 14% and 30%. We are uncertain whether there was a real difference between ongoing pregnancy rates per couple (OR 0.39, 95% CI 0.19 to 0.82; heterogeneity not applicable; 1 RCT, 223 participants; very low-quality evidence). Considering the quality of evidence, we are uncertain whether there was a difference between multiple pregnancy rates (MPR) per couple comparing a swim-up versus gradient technique (MPR per couple 0% versus 0%; 1 RCT, 25 participants; very low-quality of evidence). Considering the quality of evidence, we are also uncertain whether there was a difference between miscarriage rates (MR) per couple comparing a swim-up versus gradient technique (OR 0.85, 95% CI 0.28 to 2.59; I² = 44%; 3 RCTs, 330 participants; very low-quality evidence). No studies reported on ectopic pregnancy rate, fetal abnormalities or infection rate.\nSwim-up versus wash technique\nConsidering the quality of evidence, we are uncertain whether there is a difference in clinical pregnancy rates after a swim-up technique versus wash and centrifugation (OR 0.41, 95% CI 0.15 to 1.13; I² = 55%; 2 RCTs, 78 participants; very low-quality evidence). The results suggest that if the chance of pregnancy after the use of a wash technique is assumed to be 38%, the chance of pregnancy after using the swim-up technique is between 9% and 41%. Considering the quality of evidence, we are uncertain whether there was a difference between multiple pregnancy rates between swim-up technique versus wash technique (OR 0.49, 95% CI 0.02 to 13.28; heterogeneity not applicable; 1 RCT, 26 participants; very low-quality evidence). Miscarriage rate was only reported by one study: no miscarriages were reported in either treatment arm. No studies reported on ongoing pregnancy rate, ectopic pregnancy rate, fetal abnormalities or infection rate.\nGradient versus wash technique\nConsidering the quality of evidence, we are uncertain whether there is a difference in clinical pregnancy rates after a gradient versus wash and centrifugation technique (OR 1.78, 95% CI 0.58 to 5.46; I² = 52%; 2 RCTs, 94 participants; very low-quality evidence). The results suggest that if the chance of pregnancy after the use of a wash technique is assumed to be 13%, the chance of pregnancy after using the gradient technique is between 8% and 46%. Considering the quality of evidence, we are uncertain whether there was a difference between multiple pregnancy rates per couple between the treatment groups (OR 0.33, 95% CI 0.01 to 8.83; very low-quality evidence). Considering the quality of evidence, we are also uncertain whether there was a difference between miscarriage rates per couple between the treatment groups (OR 6.11, 95% CI 0.27 to 138.45; very low-quality evidence). No studies reported on ongoing pregnancy rate, ectopic pregnancy rate, fetal abnormalities or infection rate.\nAuthors' conclusions\nThe very low quality of the available evidence means we cannot be certain about the relative effectiveness of the different semen preparation techniques: swim-up versus gradient versus wash and centrifugation technique. No studies reported on live birth rates. We are uncertain whether there is a difference in clinical pregnancy rates, ongoing pregnancy rates, multiple pregnancy rates or miscarriage rates per couple between the three sperm preparation techniques. Further randomised trials are warranted that report live birth data\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain whether there is a difference in pregnancy outcomes between the three sperm preparation techniques for subfertile couples undergoing IUI. No studies reported on live birth rates."
}
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query-laysum | 5265 | [
{
"role": "user",
"content": "Abstract: Background\nNeonates born through meconium-stained amniotic fluid (MSAF) are at risk of developing meconium aspiration syndrome (MAS). Neonates who are non-vigorous due to intrapartum asphyxia are at higher risk of developing MAS. Clearance of meconium from the airways below the vocal cords by tracheal suction before initiating other steps of resuscitation may reduce the risk of development of MAS. However, conducting tracheal suction may not only be ineffective, it may also delay effective resuscitation, thus prolonging and worsening the hypoxic-ischaemic insult.\nObjectives\nTo evaluate the efficacy of tracheal suctioning at birth in preventing meconium aspiration syndrome and other complications among non-vigorous neonates born through meconium-stained amniotic fluid.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 11) in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) (1946 to 25 November 2020) for randomised controlled trials (RCTs) and quasi-randomised trials. We also searched clinical trials databases and the reference lists of retrieved articles for RCTs and quasi-randomised trials (up to November 2020).\nSelection criteria\nWe included studies enrolling non-vigorous neonates born through MSAF, if the intervention being tested included tracheal suction at the time of birth with an intent to clear the trachea of meconium before regular breathing efforts began. Tracheal suction could be performed with an endotracheal tube or a wide-gauge suction catheter. Neonates in the control group should have been resuscitated at birth with no effort made to clear the trachea of meconium.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data, consulting with a third review author about any disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies. Our primary outcomes were: MAS; all-cause neonatal mortality; and incidence of hypoxic-ischaemic encephalopathy (HIE). Secondary outcomes included: need for mechanical ventilation; incidence of pulmonary air leaks; culture-positive sepsis; and persistent pulmonary hypertension. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included four studies (enrolling 581 neonates) in the review. All four studies were conducted in tertiary care hospitals in India. Three of the four studies included neonates born at and beyond term gestation, whereas one included neonates born at and beyond 34 weeks of gestation. Due to the nature of the intervention, it was not possible to blind the healthcare personnel conducting the intervention.\nTracheal suction compared to no suction in non-vigorous neonates born through MSAF\nIn non-vigorous infants, no differences were noted in the risks of MAS (RR 1.00, 95% CI 0.80 to 1.25; RD 0.00, 95% CI -0.07 to 0.08; 4 studies, 581 neonates) or all-cause neonatal mortality (RR 1.24, 95% CI 0.76 to 2.02; RD 0.02, 95% CI -0.03 to 0.07; 4 studies, 575 neonates) with or without tracheal suctioning. No differences were reported in the risk of any severity HIE (RR 1.05, 95% CI 0.68 to 1.63; 1 study, 175 neonates) or moderate to severe HIE (RR 0.68, 95% CI 0.43 to 1.09; 1 study, 152 neonates) among non-vigorous neonates born through MSAF. We are also uncertain as to the effect of tracheal suction on other outcomes such as incidence of mechanical ventilation (RR 0.99, 95% CI 0.68 to 1.44; RD 0.00, 95% CI -0.06 to 0.06; 4 studies, 581 neonates), pulmonary air leaks (RR 1.22, 95% CI 0.38 to 3.93; RD 0.00, 95% CI -0.02 to 0.03; 3 studies, 449 neonates), persistent pulmonary hypertension (RR 1.29, 95% CI 0.60 to 2.77; RD 0.02, 95% CI -0.03 to 0.06; 3 studies, 406 neonates) and culture-positive sepsis (RR 1.32, 95% CI 0.48 to 3.57; RD 0.01, 95% CI -0.03 to 0.05; 3 studies, 406 neonates). All reported outcomes were judged as providing very low certainty evidence.\nAuthors' conclusions\nWe are uncertain about the effect of tracheal suction on the incidence of MAS and its complications among non-vigorous neonates born through MSAF. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the review question.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Meconium is a thick green tar-like substance, that lines a baby's intestines during pregnancy. Meconium contains various intestinal enzymes and substances (blood, skin cells, etc.) ingested by the foetus. Meconium is usually first passed within 24 hours after birth. However, in certain circumstances when blood or oxygen supply to the foetus is compromised or the pregnancy extends beyond the normal period of 40 weeks, meconium passage may occur before birth. Once passed, meconium may be breathed (aspirated) in from amniotic fluid into the airways either before birth or with the first few breaths after birth. This can cause airway obstruction and inflammation of lung tissue from toxins (chemical pneumonia). Nearly 10% to 25% of births are complicated by meconium passage before birth and of these, 5% to 12% of neonates develop meconium aspiration syndrome (MAS). MAS can present with varying degrees of severity, from mild distress to life-threatening respiratory failure. One approach to prevent MAS is to identify babies who are depressed at birth, and clear the meconium from the airway before the baby takes their first breath. In this process, an endotracheal tube is inserted into the upper trachea and pulled out while the trachea is being suctioned. However, this may not prevent MAS if the baby has already aspirated meconium before being born. In addition, most of the babies who are candidates for this intervention need prompt resuscitation, and conducting tracheal suction has the potential to cause harm by delaying the initiation of artificial breaths."
}
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query-laysum | 5266 | [
{
"role": "user",
"content": "Abstract: Background\nCritical illness is associated with uncontrolled inflammation and vascular damage which can result in multiple organ failure and death. Antithrombin III (AT III) is an anticoagulant with anti-inflammatory properties but the efficacy and any harmful effects of AT III supplementation in critically ill patients are unknown. This review was published in 2008 and updated in 2015.\nObjectives\nTo examine:\n1. The effect of AT III on mortality in critically ill participants.\n2. The benefits and harms of AT III.\nWe investigated complications specific and not specific to the trial intervention, bleeding events, the effect on sepsis and disseminated intravascular coagulation (DIC) and the length of stay in the intensive care unit (ICU) and in hospital in general.\nSearch methods\nWe searched the following databases from inception to 27 August 2015: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid SP), EMBASE (Ovid SP,), CAB, BIOSIS and CINAHL. We contacted the main authors of trials to ask for any missed, unreported or ongoing trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) irrespective of publication status, date of publication, blinding status, outcomes published, or language. We contacted the investigators and the trial authors in order to retrieve missing data. In this updated review we include trials only published as abstracts.\nData collection and analysis\nOur primary outcome measure was mortality. Two authors each independently abstracted data and resolved any disagreements by discussion. We presented pooled estimates of the intervention effects on dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CI). We performed subgroup analyses to assess risk of bias, the effect of AT III in different populations (sepsis, trauma, obstetrics, and paediatrics), and the effect of AT III in patients with or without the use of concomitant heparin. We assessed the adequacy of the available number of participants and performed trial sequential analysis (TSA) to establish the implications for further research.\nMain results\nWe included 30 RCTs with a total of 3933 participants (3882 in the primary outcome analyses).\nCombining all trials, regardless of bias, showed no statistically significant effect of AT III on mortality with a RR of 0.95 (95% CI 0.88 to 1.03), I² statistic = 0%, fixed-effect model, 29 trials, 3882 participants, moderate quality of evidence). For trials with low risk of bias the RR was 0.96 (95% Cl 0.88 to 1.04, I² statistic = 0%, fixed-effect model, 9 trials, 2915 participants) and for high risk of bias RR 0.94 (95% Cl 0.77 to 1.14, I² statistic = 0%, fixed-effect model, 20 trials, 967 participants).\nFor participants with severe sepsis and DIC the RR for mortality was non-significant, 0.95 (95% Cl 0.88 to 1.03, I² statistic = 0%, fixed-effect model, 12 trials, 2858 participants, moderate quality of evidence).\nWe conducted 14 subgroup and sensitivity analyses with respect to the different domains of risk of bias, but detected no statistically significant benefit in any subgroup analyses.\nOur secondary objective was to assess the benefits and harms of AT III. For complications specific to the trial intervention the RR was 1.26 (95% Cl 0.83 to 1.92, I² statistic = 0%, random-effect model, 3 trials, 2454 participants, very low quality of evidence). For complications not specific to the trial intervention, the RR was 0.71 (95% Cl 0.08 to 6.11, I² statistic = 28%, random-effects model, 2 trials, 65 participants, very low quality of evidence). For complications other than bleeding, the RR was 0.72 ( 95% Cl 0.42 to 1.25, I² statistic = 0%, fixed-effect model, 3 trials, 187 participants, very low quality of evidence). Eleven trials investigated bleeding events and we found a statistically significant increase, RR 1.58 (95% CI 1.35 to 1.84, I² statistic = 0%, fixed-effect model, 11 trials, 3019 participants, moderate quality of evidence) in the AT III group. The amount of red blood cells administered had a mean difference (MD) of 138.49 (95% Cl -391.35 to 668.34, I² statistic = 84%, random-effect model, 4 trials, 137 participants, very low quality of evidence). The effect of AT III in patients with multiple organ failure (MOF) was a MD of -1.24 (95% Cl -2.18 to -0.29, I² statistic = 48%, random-effects model, 3 trials, 156 participants, very low quality of evidence) and for patients with an Acute Physiology and Chronic Health Evaluation score (APACHE) at II and III the MD was -2.18 (95% Cl -4.36 to -0.00, I² statistic = 0%, fixed-effect model, 3 trials, 102 participants, very low quality of evidence). The incidence of respiratory failure had a RR of 0.93 (95% Cl 0.76 to 1.14, I² statistic = 32%, random-effects model, 6 trials, 2591 participants, moderate quality of evidence). AT III had no statistically significant impact on the duration of mechanical ventilation (MD 2.20 days, 95% Cl -1.21 to 5.60, I² statistic = 0%, fixed-effect model, 3 trials, 190 participants, very low quality of evidence); on the length of stay in the ICU (MD 0.24, 95% Cl -1.34 to 1.83, I² statistic = 0%, fixed-effect model, 7 trials, 376 participants, very low quality of evidence) or on the length of stay in hospital in general (MD 1.10, 95% Cl -7.16 to 9.36), I² statistic = 74%, 4 trials, 202 participants, very low quality of evidence).\nAuthors' conclusions\nThere is insufficient evidence to support AT III substitution in any category of critically ill participants including the subset of patients with sepsis and DIC. We did not find a statistically significant effect of AT III on mortality, but AT III increased the risk of bleeding events. Subgroup analyses performed according to duration of intervention, length of follow-up, different patient groups, and use of adjuvant heparin did not show differences in the estimates of intervention effects. The majority of included trials were at high risk of bias (GRADE; very low quality of evidence for most of the analyses). Hence a large RCT of AT III is needed, without adjuvant heparin among critically ill patients such as those with severe sepsis and DIC, with prespecified inclusion criteria and good bias protection.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, there was a low quality of information from the studies regarding all of the results. We conclude that there is a need for a large-scale clinical trial with low risk of misleading information to investigate the advantages and harms of this drug among critically ill patients."
}
]
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query-laysum | 5267 | [
{
"role": "user",
"content": "Abstract: Background\nDrowning is responsible for an estimated 320,000 deaths a year, and over 90% of drowning mortality occurs in low- to middle-income countries (LMICs), with peak drowning rates among children aged 1 to 4 years. In this age group, mortality due to drowning is particularly common in rural settings and about 75% of drowning accidents happen in natural bodies of water close to the home. Providing adequate child supervision can protect children from drowning, and organized formal day care programs could offer a way to achieve this.\nObjectives\nPrimary objective\n• To assess the effects of day care programs for children under 6 years of age on drowning-related mortality or morbidity, or on total drowning accidents (fatal and non-fatal), in LMICs, compared to no day care programs or other drowning prevention interventions\nSecondary objectives\n• To assess the effects of day care programs in LMICs for children under 6 years of age on unsafe water exposure\n• To assess safety within these programs (e.g. transmission of infection within day care, physical or sexual abuse of children within day care)\n• To assess the incidence of unintentional injury within these programs\n• To describe the cost-effectiveness of such programs, in relation to averted drowning-related mortality or morbidity\nSearch methods\nOn November 23, 2019, and for an update on August 18, 2020, we searched MEDLINE (PubMed), Embase, CENTRAL, ERIC, and CINAHL, as well as two trial registries. On December 16, 2019, and for an update on February 9, 2021, we searched 12 other resources, including websites of organizations that develop programs targeted to children.\nSelection criteria\nWe included randomized, quasi-randomized, and non-randomized controlled studies (with explicitly listed specific study design features) that implemented formal day care programs as a single program or combined with additional out-of-day care components (such as educational activities aimed at preventing injury or drowning or early childhood development activities) for children of preschool age (below 6 years of age) in LMICs for comparison with no such programs or with other drowning prevention interventions. Studies had to report at least one outcome related to drowning or injury prevention for the children enrolled.\nData collection and analysis\nTwo review authors independently performed study selection and data extraction, as well as risk of bias and GRADE assessment.\nMain results\nTwo non-randomized observational studies, conducted in rural Bangladesh, involving a total of 252,631 participants, met the inclusion criteria for this review. One of these studies compared a formal day care program combined with parent education, playpens provided to parents, and community-based activities as additional out-of-day care components versus no such program. Overall we assessed this study to be at moderate risk of bias (moderate risk of bias due to confounding, low risk of bias for other domains). This study showed that implementation of a formal day care program combined with parent education, provision of playpens to parents, and community-based activities, in a rural area with a high drowning incidence, likely reduces the risk of death from drowning over the study period of 4 years and 8 months compared to no day care program (hazard ratio 0.18, 95% confidence interval [CI] 0.06 to 0.58; 1 study, 136,577 participants; moderate-certainty evidence). Drowning morbidity (non-fatal drowning resulting in complications), total drowning (fatal and non-fatal), unsafe water exposure, and program safety (e.g. transmission of infection within day care, physical or sexual abuse of children within day care) were not reported, nor was the incidence of other unintentional injuries. Cost-effectiveness was reported as 812 USD (95% CI 589 to 1777) per disability-adjusted life-year averted as a consequence of drowning (moderate-certainty evidence). The second study compared day care programs with or without playpens provided to parents as an additional component versus only playpens provided to parents as an alternative drowning prevention intervention. Overall we assessed the study to be at critical risk of bias because we judged bias due to confounding to be at critical risk. As the certainty of evidence was very low, we are uncertain about the effects on drowning mortality rate of implementing a day care program compared to providing playpens (rate ratio 0.25, 95% CI 0.15 to 0.41; 1 study; 76,575 participants; very low-certainty evidence). Likewise, we are uncertain about the effects of a day care program with playpens provided as an additional component versus playpens provided alone (rate ratio 0.06, 95% CI 0.02 to 0.12; 1 study, 45,460 participants; very low-certainty evidence). The other outcomes of interest - drowning morbidity, total drowning, unsafe water exposure, program safety, incidence of other unintentional injuries, and cost-effectiveness - were not reported.\nAuthors' conclusions\nThis review provides evidence suggesting that a day care program with additional out-of-day care components such as community-based education, parent education, and playpens provided to parents likely reduces the drowning mortality risk in regions with a high burden of drowning compared to no intervention.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A day care program with extra features such as community-based education, parent education, and playpens provided to parents outside the day care facility probably reduces the risk of death by drowning for children under 6 years living in areas where large numbers of children drown each year."
}
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query-laysum | 5268 | [
{
"role": "user",
"content": "Abstract: Background\nUsing hypofractionation (fewer, larger doses of daily radiation) to treat localized prostate cancer may improve convenience and resource use. For hypofractionation to be feasible, it must be at least as effective for cancer-related outcomes and have comparable toxicity and quality of life outcomes as conventionally fractionated radiation therapy.\nObjectives\nTo assess the effects of hypofractionated external beam radiation therapy compared to conventionally fractionated external beam radiation therapy for men with clinically localized prostate cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and trials registries from 1946 to 15 March 2019 with reference checking, citation searching and contact with study authors. Searches were not limited by language or publication status. We reran all searches within three months (15th March 2019) prior to publication.\nSelection criteria\nRandomized controlled comparisons which included men with clinically localized prostate adenocarcinoma where hypofractionated radiation therapy (external beam radiation therapy) to the prostate using hypofractionation (greater than 2 Gy per fraction) compared with conventionally fractionated radiation therapy to the prostate delivered using standard fractionation (1.8 Gy to 2 Gy per fraction).\nData collection and analysis\nWe used standard Cochrane methodology. Two authors independently assessed trial quality and extracted data. We used Review Manager 5 for data analysis and meta-analysis. We used the inverse variance method and random-effects model for data synthesis of time-to-event data with hazard ratios (HR) and 95% confidence intervals (CI) reported. For dichotomous data, we used the Mantel-Haenzel method and random-effects model to present risk ratios (RR) and 95% CI. We used GRADE to assess evidence quality for each outcome.\nMain results\nWe included 10 studies with 8278 men in our analysis comparing hypofractionation with conventional fractionation to treat prostate cancer.\nPrimary outcomes\nHypofractionation may result in little or no difference in prostate cancer-specific survival [PC-SS] (HR 1.00, 95% CI 0.72 to 1.39; studies = 8, participants = 7946; median follow-up 72 months; low-certainty evidence). For men in the intermediate-risk group undergoing conventional fractionation this corresponds to 976 per 1000 men alive after 6 years and 0 more (44 fewer to 18 more) alive per 1000 men undergoing hypofractionation.\nWe are uncertain about the effect of hypofractionation on late radiation therapy gastrointestinal (GI) toxicity (RR 1.10, 95% CI 0.68 to 1.78; studies = 4, participants = 3843; very low-certainty evidence).\nHypofractionation probably results in little or no difference to late radiation therapy genitourinary (GU) toxicity (RR 1.05, 95% CI 0.93 to 1.18; studies = 4, participants = 3843; moderate-certainty evidence). This corresponds to 262 per 1000 late GU radiation therapy toxicity events with conventional fractionation and 13 more (18 fewer to 47 more) per 1000 men when undergoing hypofractionation.\nSecondary outcomes\nHypofractionation results in little or no difference in overall survival (HR 0.94, 95% CI 0.83 to 1.07; 10 studies, 8243 participants; high-certainty evidence). For men in the intermediate-risk group undergoing conventional fractionation this corresponds to 869 per 1000 men alive after 6 years and 17 fewer (54 fewer to 17 more) participants alive per 1000 men when undergoing hypofractionation.\nHypofractionation may result in little to no difference in metastasis-free survival (HR 1.07, 95% CI 0.65 to 1.76; 5 studies, 4985 participants; low-certainty evidence). This corresponds to 981 men per 1000 men metastasis-free at 6 years when undergoing conventional fractionation and 5 more (58 fewer to 19 more) metastasis-free per 1000 when undergoing hypofractionation.\nHypofractionation likely results in a small, possibly unimportant reduction in biochemical recurrence-free survival based on Phoenix criteria (HR 0.88, 95% CI 0.68 to 1.13; studies = 5, participants = 2889; median follow-up 90 months to 108 months; moderate-certainty evidence). In men of the intermediate-risk group, this corresponds to 804 biochemical-recurrence free men per 1000 participants at six years with conventional fractionation and 42 fewer (134 fewer to 37 more) recurrence-free men per 1000 participants with hypofractionation\nHypofractionation likely results in little to no difference to acute GU radiation therapy toxicity (RR 1.03, 95% CI 0.95 to 1.11; 4 studies, 4174 participants at 12 to 18 weeks' follow-up; moderate-certainty evidence). This corresponds to 360 episodes of toxicity per 1000 participants with conventional fractionation and 11 more (18 fewer to 40 more) per 1000 when undergoing hypofractionation.\nAuthors' conclusions\nThese findings suggest that moderate hypofractionation (up to a fraction size of 3.4 Gy) results in similar oncologic outcomes in terms of disease-specific, metastasis-free and overall survival. There appears to be little to no increase in both acute and late toxicity.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We asked if giving radiation therapy (cancer treatment with high energy x-rays) for localized prostate cancer in fewer fractions (treatment visits for radiation) and shorter overall treatment time with a larger dose (more than 2 Gray) given each day, works as well as the usual (conventional) number of fractions (1.8 Gray per day to 2 Gray per day) for cancer control and had similar side effects."
}
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query-laysum | 5269 | [
{
"role": "user",
"content": "Abstract: Background\nMailuoning is widely used in the treatment of acute ischaemic stroke in China. Animal experimental studies and clinical pharmacological research indicate that mailuoning might improve blood circulation, prevent ischaemic injury, and protect heart and brain tissue. This review was last published in 2009. As new data have become available, it is necessary to reassess the evidence from randomised controlled trials.\nObjectives\nTo determine the effects and safety of mailuoning agents (injection or oral liquid) in the treatment of people with acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL;2014, Issue 4), MEDLINE (1966 to May 2014), Embase (1980 to May 2014), AMED (1985 to May 2014), the Chinese Stroke Trials Register (June 2014), the China Biological Medicine Database (CBM-disc; 1979 to June 2014), China Science and Technology Journal database (CSTJ; 1979 to June 2014), Wanfang Data Chinese databases (1979 to June 2014), and the China National Knowledge Infrastructure (1979 to June 2014). We searched clinical trials and research registers, handsearched 10 Chinese journals including relevant conference proceedings, scanned reference lists, and contacted the pharmaceutical company that manufactures mailuoning. We also attempted to contact trial authors to obtain further data.\nSelection criteria\nRandomised controlled trials comparing mailuoning with placebo or mailuoning plus other treatment compared with that other treatment in people with acute ischaemic stroke.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, assessed trial quality, and extracted data.\nMain results\nWe included 21 trials, involving 1746 participants, in this update; six trials were new. The included trials did not report the numbers of dead and dependent participants at the end of at least three months' follow-up. Of the 12 trials that reported adverse events, five events occurred in two trials. There was no significant difference between the treatment group and the control group. We assessed 20 trials to be of a poor quality: When analysing these trials together, mailuoning was associated with a significant increase in the number of participants with an improved neurological deficit (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.23 to 0.42) and showed a significant improvement of neurological deficit with the European Stroke Scale (ESS) (mean difference (MD) (fixed) 8.29, 95% CI 3.44 to 13.15). One placebo-controlled trial, assessed to be of a better methodological quality, failed to show a significant improvement of neurological deficit at the end of three months' follow-up (MD (fixed) 2.49, 95% CI -1.45 to 6.43) or in quality of life. One trial, which reported cognitive function using the Montreal Cognitive Assessment as a continuous scale, showed a significant improvement of cognitive function (MD (fixed) 2.68, 95% CI 1.82 to 3.54). Two trials assessed activities of daily life: One trial showed a significant improvement, but the other did not.\nAuthors' conclusions\nThis review did not provide sufficient evidence to support the routine use of mailuoning for the treatment of people with acute ischaemic stroke. High-quality large-scale randomised controlled trials are needed to confirm the efficacy of mailuoning.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed 20 trials to be of a low quality. When we analysed these trials together, there was no significant difference for adverse events between the mailuoning-treatment group and the control group; mailuoning improved neurological impairment and cognitive function significantly. One trial, assessed to be of a higher quality, failed to show any significant improvement made by mailuoning on neurological deficit, activities of daily life, or quality of life. There was no convincing evidence from trials with sufficient methodological quality to support the routine use of mailuoning to promote recovery after stroke. High-quality large-scale randomised controlled trials are needed to confirm its effect."
}
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query-laysum | 5270 | [
{
"role": "user",
"content": "Abstract: Background\nChildhood constipation is a common problem with substantial health, economic and emotional burdens. Existing therapeutic options, mainly pharmacological, are not consistently effective, and some are associated with adverse effects after prolonged use. Transcutaneous electrical stimulation (TES), a non-pharmacological approach, is postulated to facilitate bowel movement by modulating the nerves of the large bowel via the application of electrical current transmitted through the abdominal wall.\nObjectives\nOur main objective was to evaluate the effectiveness and safety of TES when employed to improve bowel function and constipation-related symptoms in children with constipation.\nSearch methods\nWe searched MEDLINE (PubMed) (1950 to July 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 7, 2015), EMBASE (1980 to July 2015), the Cochrane IBD Group Specialized Register, trial registries and conference proceedings to identify applicable studies .\nSelection criteria\nRandomized controlled trials that assessed any type of TES, administered at home or in a clinical setting, compared to no treatment, a sham TES, other forms of nerve stimulation or any other pharmaceutical or non-pharmaceutical measures used to treat constipation in children were considered for inclusion.\nData collection and analysis\nTwo authors independently assessed studies for inclusion, extracted data and assessed risk of bias of the included studies. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for categorical outcomes data and the mean difference (MD) and corresponding 95% CI for continuous outcomes. We evaluated the overall quality of the evidence supporting the outcomes assessed in this review using the GRADE criteria.\nMain results\nOne study from Australia including 46 children aged 8 to 18 years was eligible for inclusion. There were multiple reports identified, including one unpublished report, that focused on different outcomes of the same study. The study had unclear risk of selection bias, high risks of performance, detection and attrition biases, and low risks of reporting biases.\nWe are very uncertain about the effects of TES on bowel movements, colonic transit, soiling symptoms and quality of life due to high risk of bias, indirectness and imprecision. For our outcomes of interest the 95% CI of most analysis results include potential benefit and no effect. There is insufficient evidence to determine the effect of TES on bowel movements and colonic transit. The study reported that 16/21 children in the TES group and 15/21 in the sham group had > 3 complete spontaneous bowel movements (CSBM) per week (RR 1.07, 95% CI 0.74 to 1.53; very low-quality evidence). Ten out of 14 children in the TES group had improved colonic transit compared to 1/7 in the sham group (RR 5.00, 95% CI 0.79 to 31.63; very low-quality evidence). Mean colonic transit rate, measured as the position of the geometric centre of the radioactive substance ingested along the intestinal tract, was higher in children who received TES compared to sham (MD 1.05, 95% CI 0.36 to 1.74; one study, 30 participants; very low-quality evidence). The radiological assessment of colonic transit outcomes means that these results might not translate to important improvement in clinical symptoms or increased bowel movements. There is insufficient evidence to determine the effect of TES on symptoms and quality of life (QoL) outcomes. Nine out of 13 children in the TES group had improved soiling-related symptoms compared to 4/12 sham participants (RR 2.08, 95% CI 0.86 to 5.00; very low-quality evidence). Four out of 8 TES participants reported an improvement in QoL compared to 1/8 sham participants (RR 4.00, 95% CI 0.56 to 28.40; very low-quality evidence). The effects of TES on self-perceived (MD 5.00, 95% CI -1.21 to 11.21; one study, 33 participants; very low-quality evidence) or parent-perceived QoL (MD -0.20, 95% CI -7.57 to 7.17, one study, 33 participants; very low-quality evidence) are uncertain. No adverse effects were reported in the included study.\nAuthors' conclusions\nThe results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the efficacy and safety of TES in children with chronic constipation can be drawn. Further randomized controlled trials assessing TES for the management of childhood constipation should be conducted. Future trials should include clear documentation of methodologies, especially measures to evaluate the effectiveness of blinding, and incorporate patient-important outcomes such as the number of patients with improved CSBM, improved clinical symptoms and quality of life.\n\nGiven the provided abstract, please respond to the following query: \"Source of funding\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The study was funded by the Australian National Health and Medical Research Council and Murdoch Children's Research Institute Theme Investment Grants."
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query-laysum | 5271 | [
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring. The prevalence of SAD ranges from 1.5% to 9%, depending on latitude. The predictable seasonal aspect of SAD provides a promising opportunity for prevention. This review - one of four reviews on efficacy and safety of interventions to prevent SAD - focuses on second-generation antidepressants (SGAs).\nObjectives\nTo assess the efficacy and safety of SGAs (in comparison with other SGAs, placebo, light therapy, melatonin or agomelatine, psychological therapies or lifestyle interventions) in preventing SAD and improving patient-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nFor efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. For adverse events, we planned to include non-randomised studies. Eligible studies compared a SGA versus another SGA, placebo, light therapy, psychological therapy, melatonin, agomelatine or lifestyle changes. We also intended to compare SGAs in combination with any of the comparator interventions versus placebo or the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text publications, extracted data and assessed risk of bias of included studies. When data were sufficient, we conducted random-effects (Mantel-Haenszel) meta-analyses. We assessed statistical heterogeneity by calculating the Chi2 statistic and the Cochran Q. We used the I2 statistic to estimate the magnitude of heterogeneity. We assessed publication bias by using funnel plots.We rated the strength of the evidence using the system developed by the GRADE Working Group.\nMain results\nWe identified 3745 citations after de-duplication of search results and excluded 3619 records during title and abstract reviews. We assessed 126 full-text papers for inclusion in the review, of which four publications (on three RCTs) providing data from 1100 people met eligibility criteria for this review. All three RCTs had methodological limitations due to high attrition rates.\nOverall, moderate-quality evidence indicates that bupropion XL is an efficacious intervention for prevention of recurrence of depressive episodes in people with a history of SAD (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.44 to 0.72; 3 RCTs, 1100 participants). However, bupropion XL leads to greater risk of headaches (moderate-quality evidence), insomnia and nausea (both low-quality evidence) when compared with placebo. Numbers needed to treat for additional beneficial outcomes (NNTBs) vary by baseline risks. For a population with a yearly recurrence rate of 30%, the NNTB is 8 (95% CI 6 to 12). For populations with yearly recurrence rates of 50% and 60%, NNTBs are 5 (95% CI 4 to 7) and 4 (95% CI 3 to 6), respectively.\nWe could find no studies on other SGAs and no studies comparing SGAs with other interventions of interest, such as light therapy, psychological therapies, melatonin or agomelatine.\nAuthors' conclusions\nAvailable evidence indicates that bupropion XL is an effective intervention for prevention of recurrence of SAD. Nevertheless, even in a high-risk population, three out of four people will not benefit from preventive treatment with bupropion XL and will be at risk for harm. Clinicians need to discuss with patients advantages and disadvantages of preventive SGA treatment, and might want to consider offering other potentially efficacious interventions, which might confer a lower risk of adverse events. Given the lack of comparative evidence, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences.\nFuture researchers need to assess the effectiveness and risk of harms of SGAs other than bupropion for prevention of SAD. Investigators also need to compare benefits and harms of pharmacological and non-pharmacological interventions.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Many people in northern latitudes suffer from winter blues, which occurs as a reaction to reduced sunlight. Three-quarters of those affected are women. Lethargy, overeating, craving for carbohydrates and depressed mood are common symptoms. In some people, winter blues becomes depression, which seriously affects their daily lives. Up to two-thirds experience depressive symptoms every winter."
}
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query-laysum | 5272 | [
{
"role": "user",
"content": "Abstract: Background\nHysterosalpingography (HSG) is a method of testing for tubal patency. However, women struggle to tolerate the procedure, as it is associated with some discomfort. Various pharmacological strategies are available that may reduce pain during the procedure, though there is no consensus as to the best method.\nObjectives\nTo compare the effectiveness of different types of pharmacological interventions for pain relief in women undergoing HSG for investigation of subfertility.\nSearch methods\nThis review has drawn on the search strategy developed for the Cochrane Menstrual Disorders and Subfertility Group (MDSG). We searched the following databases to 15 April 2015: MDSG Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO.\nSelection criteria\nAll identified randomised controlled trials investigating pharmacological interventions for pain relief during HSG were investigated for selection.\nData collection and analysis\nFour review authors independently extracted data. We combined data to calculate mean differences (MDs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nThe search identified 23 trials (1272 women) that were eligible for inclusion into the study.\nOral opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral opioid analgesia in reducing pain during the procedure (MD −0.91, 95% CI −1.88 to 0.06, 1 study, n = 128, low quality evidence) or more than 30 minutes after the procedure (MD −0.99, 95% CI −1.75 to −0.23, 1 study, n = 128, moderate quality evidence)\nNo studies reported on the effect of oral opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes after the procedure\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nIntravenous opioid analgesia versus placebo/no treatment\nThere was evidence that intravenous opioids may improve pain relief during the procedure compared to no treatment (MD −3.53, 95% CI −4.29 to −2.77, 1 study, n = 62, moderate quality evidence)\nNo studies reported on the effect of intravenous opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes and more than 30 minutes after the procedure\nIn terms of adverse effects, one trial reported 1/32 participants had apnoea with intravenous remifentanil. Recovery time was nearly 4 minutes longer in the remifentanil group compared to the control.\nOral non-opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral non-opioid analgesia in reducing pain during the procedure (MD −0.13, 95% CI −0.48 to 0.23, 3 studies, n = 133, I² = 61%, low quality evidence), less than 30 minutes after the procedure (MD −0.30, 95% CI −1.03 to 0.43, 2 studies, n = 45, I² = 97%, very low quality evidence), or more than 30 minutes after the procedure (MD −0.36, 95% CI −1.06 to 0.34, 3 studies, n = 133, I² = 58%, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nTopical anaesthesia versus placebo/no treatment\nThere was evidence that topical anaesthetics may reduce pain during the procedure (MD −0.63, 95% CI −1.06 to −0.19, 9 studies, n = 613, I² = 66%, low quality evidence).\nThere was no evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD 0.42, 95% CI -0.03 to 0.86, 5 studies, n = 373, I² = 59%, very low quality evidence).\nThere was evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain more than 30 minutes after the procedure (MD −1.38, 95% CI -3.44 to −0.68, 2 studies, n = 166, I² = 92%, very low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nLocally injected anaesthesia versus placebo/no treatment\nThere was evidence of effect that locally injected anaesthetic can reduce pain during the procedure (MD −1.31, 95% CI −1.55 to −1.07, 2 studies, n = 125, I² = 0%, very low quality evidence).\nThere was no evidence of effect for locally injected anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD −1.31, 95% CI −2.14 to −0.49, 2 studies, n = 125, I² = 46%, low quality evidence).\nNo studies were included into the analysis of the effect of locally injected anaesthesia, when injected prior to the procedure, in reducing pain more than 30 minutes after the procedure.\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAny analgesic versus any other analgesic\nThere was no evidence of a difference between the groups when oral non-opioid analgesia was compared to opioid analgesia for pain relief during the procedure (MD 1.10, 95% CI −0.26 to 2.46, 1 study, n = 91, low quality evidence); less than 30 minutes following the procedure (MD −0.30, 95% CI −1.00 to 0.40, 1 study, n = 91, low quality evidence); and more than 30 minutes following the procedure (MD −0.60, 95% CI −1.56 to 0.36, 1 study, n = 91, low quality evidence). Topical anaesthetics were found to be more effective than paracervical block for pain relief during HSG (MD −2.73, 95% CI −3.86 to −1.60, 1 study, n = 20, moderate quality evidence). This benefit did not extend to within 30 minutes following HSG (MD −1.03, 95% CI −2.52 to 0.46, 1 study, n = 20, low quality evidence); or 30 minutes or more after HSG (MD 0.31, 95% CI −0.87 to 1.49, 1 study, n = 20, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAuthors' conclusions\nTopical anaesthetic applied before the procedure may be associated with effective pain relief during HSG, though the quality of this evidence is low. Intravenous opioids may also be effective in pain relief, though this must be weighed against their side effects and their effects on the recovery time. There is insufficient evidence to draw conclusions on the efficacy of other analgesics for HSG, or to reach any other conclusions regarding adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Only topical anaesthetics and intravenous opioids were found to be of benefit in reducing pain during the procedure, though the quality of this evidence is low to moderate, and there is no evidence that these are effective at relieving pain following the procedure. There is insufficient evidence for other drug treatments in reducing pain during HSG. There was insufficient evidence to reach any conclusions regarding adverse effects."
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query-laysum | 5273 | [
{
"role": "user",
"content": "Abstract: Background\nInositol is an essential nutrient required by human cells in culture for growth and survival. Inositol promotes maturation of several components of surfactant and may play a critical role in fetal and early neonatal life. A drop in inositol levels in infants with respiratory distress syndrome (RDS) can be a sign that their illness will be severe.\nObjectives\nTo assess the effectiveness and safety of supplementary inositol in preterm infants with or without respiratory distress syndrome (RDS) in reducing adverse neonatal outcomes including: death (neonatal and infant deaths), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC) and sepsis.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 11), MEDLINE via PubMed (1966 to 5 November 2018), Embase (1980 to 5 November 2018), and CINAHL (1982 to 5 November 2018). We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCT) and quasi-randomised trials.\nSelection criteria\nWe included all randomised controlled trials of inositol supplementation of preterm infants compared with a control group that received a placebo or no intervention. Outcomes included neonatal death, infant death, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC) and sepsis.\nData collection and analysis\nThe three review authors independently abstracted data on neonatal outcomes and resolved any disagreements through discussion and consensus. Outcomes were reported as typical risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH). We used the GRADE approach to assess the quality of evidence.\nMain results\nSix published randomised controlled trials were identified, with a total of 1177 infants. Study quality varied for the comparison 'Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control' and interim analyses had occurred in several trials for the outcomes of interest. In this comparison, neonatal death was found to be significantly reduced (typical RR 0.53, 95% CI 0.31 to 0.91; typical RD −0.09, 95% CI −0.16 to −0.01; NNTB 11, 95% CI 6 to 100; 3 trials, 355 neonates). Infant deaths were not reduced (typical RR 0.89, 95% CI 0.71 to 1.13; typical RD −0.02, 95% CI −0.07 to 0.02; 5 trials, 1115 infants) (low-quality evidence). ROP stage 2 or higher or stage 3 or higher was not significantly reduced (typical RR 0.89, 95% CI 0.75 to 1.06; typical RD −0.04, 95% CI −0.10 to 0.02; 3 trials, 810 infants) (moderate-quality evidence). There were no significant findings for ROP (any stage), NEC (suspected or proven), sepsis, IVH grade greater than II (moderate-quality evidence). For the comparison 'Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at less than 30 weeks' postmenstrual age (PMA) compared to placebo for preterm infants at risk for or having respiratory distress syndrome' the results from two studies of high quality were included (N = 760 neonates). Recruitment to the larger study (N = 638) was terminated because of a higher rate of deaths in the inositol group. We did not downgrade the quality of the study. The meta-analyses of the outcomes of 'Type 1 ROP or death before determination of ROP outcome using the adjudicated ROP outcome', 'Type 1 ROP including adjudicated ROP outcome', 'All-cause mortality (outcome collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)' and 'Severe IVH (grade 3 or 4)' did not show significant findings (moderate-quality evidence). There were no significant findings for the outcomes 'BPD or death by it prior to 37 weeks' postmenstrual age (outcomes collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)', 'Late onset sepsis (> 72 hours of age)', and 'Suspected or proven NEC' (high-quality evidence).\nAuthors' conclusions\nBased on the evidence from randomised controlled trials to date, inositol supplementation does not result in important reductions in the rates of infant deaths, ROP stage 3 or higher, type 1 ROP, IVH grades 3 or 4, BPD, NEC, or sepsis. These conclusions are based mainly on two recent randomised controlled trials in neonates less than 30 weeks' postmenstrual age (N = 760), the most vulnerable population. Currently inositol supplementation should not be routinely instituted as part of the nutritional management of preterm infants with or without RDS. It is important that infants who have been enrolled in the trials included in this review are followed to assess any effects of inositol supplementation on long-term outcomes in childhood. We do not recommend any additional trials in neonates.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "Inositol is an essential nutrient for cells, with high concentrations in breast milk (particularly in the breast milk of mothers whose babies have been born early). A drop in inositol levels in babies with respiratory distress syndrome (RDS) can be a sign that their illness will be severe. Inositol is thought to be an important nutrient in development before and after birth."
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query-laysum | 5274 | [
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"content": "Abstract: Background\nMedication errors are preventable events that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional or patient. Medication errors in hospitalised adults may cause harm, additional costs, and even death.\nObjectives\nTo determine the effectiveness of interventions to reduce medication errors in adults in hospital settings.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, five other databases and two trials registers on 16 January 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and interrupted time series (ITS) studies investigating interventions aimed at reducing medication errors in hospitalised adults, compared with usual care or other interventions. Outcome measures included adverse drug events (ADEs), potential ADEs, preventable ADEs, medication errors, mortality, morbidity, length of stay, quality of life and identified/solved discrepancies. We included any hospital setting, such as inpatient care units, outpatient care settings, and accident and emergency departments.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care (EPOC) Group. Where necessary, we extracted and reanalysed ITS study data using piecewise linear regression, corrected for autocorrelation and seasonality, where possible.\nMain results\nWe included 65 studies: 51 RCTs and 14 ITS studies, involving 110,875 participants. About half of trials gave rise to 'some concerns' for risk of bias during the randomisation process and one-third lacked blinding of outcome assessment. Most ITS studies presented low risk of bias. Most studies came from high-income countries or high-resource settings. Medication reconciliation –the process of comparing a patient's medication orders to the medications that the patient has been taking– was the most common type of intervention studied. Electronic prescribing systems, barcoding for correct administering of medications, organisational changes, feedback on medication errors, education of professionals and improved medication dispensing systems were other interventions studied.\nMedication reconciliation\nLow-certainty evidence suggests that medication reconciliation (MR) versus no-MR may reduce medication errors (odds ratio [OR] 0.55, 95% confidence interval (CI) 0.17 to 1.74; 3 studies; n=379). Compared to no-MR, MR probably reduces ADEs (OR 0.38, 95%CI 0.18 to 0.80; 3 studies, n=1336 ; moderate-certainty evidence), but has little to no effect on length of stay (mean difference (MD) -0.30 days, 95%CI -1.93 to 1.33 days; 3 studies, n=527) and quality of life (MD -1.51, 95%CI -10.04 to 7.02; 1 study, n=131).\nLow-certainty evidence suggests that, compared to MR by other professionals, MR by pharmacists may reduce medication errors (OR 0.21, 95%CI 0.09 to 0.48; 8 studies, n=2648) and may increase ADEs (OR 1.34, 95%CI 0.73 to 2.44; 3 studies, n=2873). Compared to MR by other professionals, MR by pharmacists may have little to no effect on length of stay (MD -0.25, 95%CI -1.05 to 0.56; 6 studies, 3983). Moderate-certainty evidence shows that this intervention probably has little to no effect on mortality during hospitalisation (risk ratio (RR) 0.99, 95%CI 0.57 to 1.7; 2 studies, n=1000), and on readmissions at one month (RR 0.93, 95%CI 0.76 to 1.14; 2 studies, n=997); and low-certainty evidence suggests that the intervention may have little to no effect on quality of life (MD 0.00, 95%CI -14.09 to 14.09; 1 study, n=724).\nLow-certainty evidence suggests that database-assisted MR conducted by pharmacists, versus unassisted MR conducted by pharmacists, may reduce potential ADEs (OR 0.26, 95%CI 0.10 to 0.64; 2 studies, n=3326), and may have no effect on length of stay (MD 1.00, 95%CI -0.17 to 2.17; 1 study, n=311).\nLow-certainty evidence suggests that MR performed by trained pharmacist technicians, versus pharmacists, may have little to no difference on length of stay (MD -0.30, 95%CI -2.12 to 1.52; 1 study, n=183). However, the CI is compatible with important beneficial and detrimental effects.\nLow-certainty evidence suggests that MR before admission may increase the identification of discrepancies compared with MR after admission (MD 1.27, 95%CI 0.46 to 2.08; 1 study, n=307). However, the CI is compatible with important beneficial and detrimental effects.\nModerate-certainty evidence shows that multimodal interventions probably increase discrepancy resolutions compared to usual care (RR 2.14, 95%CI 1.81 to 2.53; 1 study, n=487).\nComputerised physician order entry (CPOE)/clinical decision support systems (CDSS)\nModerate-certainty evidence shows that CPOE/CDSS probably reduce medication errors compared to paper-based systems (OR 0.74, 95%CI 0.31 to 1.79; 2 studies, n=88).\nModerate-certainty evidence shows that, compared with standard CPOE/CDSS, improved CPOE/CDSS probably reduce medication errors (OR 0.85, 95%CI 0.74 to 0.97; 2 studies, n=630).\nLow-certainty evidence suggests that prioritised alerts provided by CPOE/CDSS may prevent ADEs compared to non-prioritised (inconsequential) alerts (MD 1.98, 95%CI 1.65 to 2.31; 1 study; participant numbers unavailable).\nBarcode identification of participants/medications\nLow-certainty evidence suggests that barcoding may reduce medication errors (OR 0.69, 95%CI 0.59 to 0.79; 2 studies, n=50,545).\nReduced working hours\nLow-certainty evidence suggests that reduced working hours may reduce serious medication errors (RR 0.83, 95%CI 0.63 to 1.09; 1 study, n=634). However, the CI is compatible with important beneficial and detrimental effects.\nFeedback on prescribing errors\nLow-certainty evidence suggests that feedback on prescribing errors may reduce medication errors (OR 0.47, 95%CI 0.33 to 0.67; 4 studies, n=384).\nDispensing system\nLow-certainty evidence suggests that dispensing systems in surgical wards may reduce medication errors (OR 0.61, 95%CI 0.47 to 0.79; 2 studies, n=1775).\nAuthors' conclusions\nLow- to moderate-certainty evidence suggests that, compared to usual care, medication reconciliation, CPOE/CDSS, barcoding, feedback and dispensing systems in surgical wards may reduce medication errors and ADEs. However, the results are imprecise for some outcomes related to medication reconciliation and CPOE/CDSS. The evidence for other interventions is very uncertain. Powered and methodologically sound studies are needed to address the identified evidence gaps. Innovative, synergistic strategies –including those that involve patients– should also be evaluated.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Medication reconciliation compared with no medication reconciliation probably reduce ADEs and may reduce medication errors. It may have little to no effect on length of stay or quality of life. However, the effect of medication reconciliation on these latter outcomes is imprecise; it is not clear if the effects are beneficial or detrimental (low- to moderate-certainty evidence).\nCompared to medication reconciliation by other professionals, medication reconciliation performed by pharmacists may increase ADEs (but this result is imprecise); may reduce medication errors; and may have little to no effect on length of stay, mortality during hospitalisation, and readmissions. However, these effects are imprecise (low-certainty evidence).\nCompared to no assistance, database-assisted medication reconciliation conducted by pharmacists may reduce potential ADEs and may have no effect on length of stay, but the last effect is imprecise (low-certainty evidence).\nMedication reconciliation performed by trained pharmacist technicians instead of pharmacists, may have no effect on length of stay, but this effect is imprecise (low-certainty evidence).\nMedication reconciliation before admission, versus after admission, may increase identified discrepancies; however, the effect is imprecise (low-certainty evidence).\nCompared to usual care, some interventions have different effects:\nMultimodal interventions probably increase discrepancy resolutions (moderate-certainty evidence).\nElectronic prescribing systems probably reduce medication errors and ADEs. Prioritised alerts may additionally prevent ADEs (low- to moderate-certainty evidence).\nBarcode identification of participants or medications may reduce medication errors (low-certainty evidence).\nReduced working hours and feedback on medication errors may reduce serious medication errors; however, the effect is imprecise (low-certainty evidence)."
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"content": "Abstract: Background\nAntiplatelet agents are widely used to prevent cardiovascular events. The risks and benefits of antiplatelet agents may be different in people with chronic kidney disease (CKD) for whom occlusive atherosclerotic events are less prevalent, and bleeding hazards might be increased. This is an update of a review first published in 2013.\nObjectives\nTo evaluate the benefits and harms of antiplatelet agents in people with any form of CKD, including those with CKD not receiving renal replacement therapy, patients receiving any form of dialysis, and kidney transplant recipients.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 13 July 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe selected randomised controlled trials of any antiplatelet agents versus placebo or no treatment, or direct head-to-head antiplatelet agent studies in people with CKD. Studies were included if they enrolled participants with CKD, or included people in broader at-risk populations in which data for subgroups with CKD could be disaggregated.\nData collection and analysis\nFour authors independently extracted data from primary study reports and any available supplementary information for study population, interventions, outcomes, and risks of bias. Risk ratios (RR) and 95% confidence intervals (CI) were calculated from numbers of events and numbers of participants at risk which were extracted from each included study. The reported RRs were extracted where crude event rates were not provided. Data were pooled using the random-effects model. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe included 113 studies, enrolling 51,959 participants; 90 studies (40,597 CKD participants) compared an antiplatelet agent with placebo or no treatment, and 29 studies (11,805 CKD participants) directly compared one antiplatelet agent with another. Fifty-six new studies were added to this 2021 update. Seven studies originally excluded from the 2013 review were included, although they had a follow-up lower than two months.\nRandom sequence generation and allocation concealment were at low risk of bias in 16 and 22 studies, respectively. Sixty-four studies reported low-risk methods for blinding of participants and investigators; outcome assessment was blinded in 41 studies. Forty-one studies were at low risk of attrition bias, 50 studies were at low risk of selective reporting bias, and 57 studies were at low risk of other potential sources of bias.\nCompared to placebo or no treatment, antiplatelet agents probably reduces myocardial infarction (18 studies, 15,289 participants: RR 0.88, 95% CI 0.79 to 0.99, I² = 0%; moderate certainty). Antiplatelet agents has uncertain effects on fatal or nonfatal stroke (12 studies, 10.382 participants: RR 1.01, 95% CI 0.64 to 1.59, I² = 37%; very low certainty) and may have little or no effect on death from any cause (35 studies, 18,241 participants: RR 0.94, 95 % CI 0.84 to 1.06, I² = 14%; low certainty). Antiplatelet therapy probably increases major bleeding in people with CKD and those treated with haemodialysis (HD) (29 studies, 16,194 participants: RR 1.35, 95% CI 1.10 to 1.65, I² = 12%; moderate certainty). In addition, antiplatelet therapy may increase minor bleeding in people with CKD and those treated with HD (21 studies, 13,218 participants: RR 1.55, 95% CI 1.27 to 1.90, I² = 58%; low certainty). Antiplatelet treatment may reduce early dialysis vascular access thrombosis (8 studies, 1525 participants) RR 0.52, 95% CI 0.38 to 0.70; low certainty). Antiplatelet agents may reduce doubling of serum creatinine in CKD (3 studies, 217 participants: RR 0.39, 95% CI 0.17 to 0.86, I² = 8%; low certainty). The treatment effects of antiplatelet agents on stroke, cardiovascular death, kidney failure, kidney transplant graft loss, transplant rejection, creatinine clearance, proteinuria, dialysis access failure, loss of primary unassisted patency, failure to attain suitability for dialysis, need of intervention and cardiovascular hospitalisation were uncertain. Limited data were available for direct head-to-head comparisons of antiplatelet drugs, including prasugrel, ticagrelor, different doses of clopidogrel, abciximab, defibrotide, sarpogrelate and beraprost.\nAuthors' conclusions\nAntiplatelet agents probably reduced myocardial infarction and increased major bleeding, but do not appear to reduce all-cause and cardiovascular death among people with CKD and those treated with dialysis. The treatment effects of antiplatelet agents compared with each other are uncertain.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "People with chronic kidney disease (CKD) have an increased risk of heart disease that can block the blood supply to the heart or brain causing a heart attack or stroke. Drugs that prevent blood clots from forming (antiplatelet agents) can prevent deaths caused by clots in arteries in the general adult population. However, there may be fewer benefits for people who have CKD, because blood clots in arteries is a less common cause of death or reason to be admitted to hospital compared with heart failure or sudden death in these people. People with CKD also have an increased tendency for bleeding due to changes in how the blood clots. Antiplatelet agents may therefore be more hazardous when CKD is present."
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"content": "Abstract: Background\nInflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial.\nObjectives\nThe primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials.\nSelection criteria\nRandomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nWe included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study).\nAll studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used.\nIn one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9).\nIn one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36).\nThere were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk.\nThe reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events.\nTime to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies.\nAn analysis of all intravenous iron preparations to all oral iron preparations showed that intravenous administration may lead to more responders (368/554 versus 205/373, RR 1.17, 95% CI 1.05 to 1.31, NNTB = 11, low-certainty due to risk of bias and inconsistency). Withdrawals due to adverse events may be greater in oral iron preparations vs intravenous (15/554 versus 31/373, RR 0.39, 95% CI 0.20 to 0.74, low-certainty due to risk of bias, inconsistency and imprecision).\nAuthors' conclusions\nIntravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo.\nWe are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11.\nWhilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery.\nOther outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes.\nGiven the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "This review is up-to-date as of November 2019."
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{
"role": "user",
"content": "Abstract: Background\nUncontrolled bleeding is an important cause of death in trauma victims. Antifibrinolytic treatment has been shown to reduce blood loss following surgery and may also be effective in reducing blood loss following trauma.\nObjectives\nTo assess the effect of antifibrinolytic drugs in patients with acute traumatic injury.\nSearch methods\nWe ran the most recent search in January 2015. We searched the Cochrane Injuries Group's Specialised Register, The Cochrane Library, Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic+Embase (OvidSP), PubMed and clinical trials registries.\nSelection criteria\nRandomised controlled trials of antifibrinolytic agents (aprotinin, tranexamic acid [TXA], epsilon-aminocaproic acid and aminomethylbenzoic acid) following acute traumatic injury.\nData collection and analysis\nFrom the results of the screened electronic searches, bibliographic searches, and contacts with experts, two authors independently selected trials meeting the inclusion criteria, and extracted data. One review author assessed the risk of bias for key domains.\nOutcome measures included: mortality at end of follow-up (all-cause); adverse events (specifically vascular occlusive events [myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism] and renal failure); number of patients undergoing surgical intervention or receiving blood transfusion; volume of blood transfused; volume of intracranial bleeding; brain ischaemic lesions; death or disability.\nWe rated the quality of the evidence as 'high', 'moderate', 'low' or 'very low' according to the GRADE approach.\nMain results\nThree trials met the inclusion criteria.\nTwo trials (n = 20,451) assessed the effect of TXA. The larger of these (CRASH-2, n = 20,211) was conducted in 40 countries and included patients with a variety of types of trauma; the other (n = 240) restricted itself to those with traumatic brain injury (TBI) only.\nOne trial (n = 77) assessed aprotinin in participants with major bony trauma and shock.\nThe pooled data show that antifibrinolytic drugs reduce the risk of death from any cause by 10% (RR 0.90, 95% CI 0.85 to 0.96; P = 0.002) (quality of evidence: high). This estimate is based primarily on data from the CRASH-2 trial of TXA, which contributed 99% of the data.\nThere is no evidence that antifibrinolytics have an effect on the risk of vascular occlusive events (quality of evidence: moderate), need for surgical intervention or receipt of blood transfusion (quality of evidence: high). There is no evidence for a difference in the effect by type of antifibrinolytic (TXA versus aprotinin) however, as the pooled analyses were based predominantly on trial data concerning the effects of TXA, the results can only be confidently applied to the effects of TXA. The effects of aprotinin in this patient group remain uncertain.\nThere is some evidence from pooling data from one study (n = 240) and a subset of data from CRASH-2 (n = 270) in patients with TBI which suggest that TXA may reduce mortality although the estimates are imprecise, the quality of evidence is low, and uncertainty remains. Stronger evidence exists for the possibility of TXA reducing intracranial bleeding in this population.\nAuthors' conclusions\nTXA safely reduces mortality in trauma patients with bleeding without increasing the risk of adverse events. TXA should be given as early as possible and within three hours of injury, as further analysis of the CRASH-2 trial showed that treatment later than this is unlikely to be effective and may be harmful. Although there is some promising evidence for the effect of TXA in patients with TBI, substantial uncertainty remains.\nTwo ongoing trials being conducted in patients with isolated TBI should resolve these remaining uncertainties.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this review is current to January 2015."
}
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query-laysum | 5278 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is one of the most common neurological disorders. Many people with epilepsy are drug-resistant and require add-on therapy, meaning that they concomitantly take multiple antiepileptic drugs. Carisbamate is a drug which is taken orally and inhibits voltage-gated sodium channels. Carisbamate may be useful for drug-resistant focal epilepsy.\nObjectives\nTo evaluate the efficacy and tolerability of carisbamate when used as an add-on therapy for drug-resistant focal epilepsy.\nSearch methods\nWe searched the following databases on 8 April 2021: Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) 1946 to April 07, 2021. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, WHO ICTRP, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane review groups including Epilepsy. We also searched ongoing trials registers, checked reference lists, and contacted authors of the included trials.\nSelection criteria\nDouble-blind randomised controlled trials (RCTs) comparing carisbamate versus placebo or another antiepileptic drug, as add-on therapy for drug-resistant focal epilepsy. Trials could have a parallel-group or cross-over design.\nData collection and analysis\nTwo review authors independently selected the trials for inclusion, assessed trial quality, and extracted data. The primary outcome was 50% or greater reduction in seizure frequency (responder rate). The secondary outcomes were: seizure freedom, treatment withdrawal (for any reason and due to adverse events); adverse events, and quality of life. We analysed data using the Mantel-Haenszel statistical method and according to the intention-to-treat population. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs).\nMain results\nWe included four RCTs involving a total of 2211 participants. All four trials compared carisbamate with placebo for drug-resistant focal epilepsy. Participants in all trials were over 16 years of age and received at least one other antiepileptic drug concomitantly. We detected substantial risk of bias across the included trials. All four trials were at high risk of attrition bias due to the incomplete reporting of attrition and the high treatment withdrawal rates noted, especially with higher doses. All four trials also had unclear risk of detection bias, as they did not specify whether outcome assessors were blinded.\nMeta-analysis suggested that carisbamate produced a higher responder rate compared to placebo (RR 1.36, 95% CI 1.14 to 1.62; 4 studies; moderate-certainty evidence). More participants in the carsibamate group achieved seizure freedom (RR 2.43, 95% CI 0.84 to 7.03; 1 study); withdrew from treatment for any reason (RR 1.32, 95% CI 0.82 to 2.12; 4 studies); and withdrew from treatment due to adverse events (RR 1.80, 95% CI 0.78 to 4.17; 4 studies) than in the placebo group. However, the evidence for the three outcomes was very low-certainty. There was no difference between treatment groups for the proportion of participants experiencing at least one adverse event (RR 1.10, 95% CI 0.93 to 1.30; 2 studies; low-certainty evidence). More participants in the carisbamate group than in the placebo group developed dizziness (RR 2.06, 95% CI 1.23 to 3.44; 4 studies; very low-certainty evidence) and somnolence (RR 1.82, 95% CI 1.28 to 2.58; 4 studies; low-certainty evidence), but not fatigue (RR 1.11, 95% CI 0.73 to 1.68; 3 studies); headache (RR 1.13, 95% CI 0.92 to 1.38; 4 studies); or nausea (RR 1.19, 95% CI 0.81 to 1.75; 3 studies). None of the included trials reported quality of life.\nAuthors' conclusions\nThe results suggest that carisbamate may demonstrate efficacy and tolerability as an add-on therapy for drug-resistant focal epilepsy. Importantly, the evidence for all outcomes except responder rate was of low to very low certainty, therefore we are uncertain of the accuracy of the reported effects. The certainty of the evidence is limited by the significant risk of bias associated with the included studies, as well as the statistical heterogeneity detected for some outcomes. Consequently, it is difficult for these findings to inform clinical practice. The studies were all of short duration and only included adult study populations. There is a need for further RCTs with more clear methodology, long-term follow-up, more clinical outcomes, more seizure types, and a broader range of participants.\n\nGiven the provided abstract, please respond to the following query: \"Aim of review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review evaluated the effectiveness and tolerability of carisbamate when used as an add-on treatment (a treatment added to other antiepileptic drugs) for drug-resistant focal epilepsy.\nThe evidence is current to April 2021."
}
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query-laysum | 5279 | [
{
"role": "user",
"content": "Abstract: Background\nThe modalities of therapy for obstructive sleep apnoea (OSA) include behavioural and lifestyle modifications, positional therapy, oral appliances, surgery and continuous positive airway pressure therapy (CPAP). Though CPAP has proven efficacy in treating OSA, adherence with CPAP therapy is suboptimal. Positional therapy (to keep people sleeping on their side) is less invasive and therefore expected to have better adherence. This review considered the efficacy of positional therapy compared to CPAP as well as positional therapy against no positional therapy. Devices designed for positional therapy include lumbar or abdominal binders, semi-rigid backpacks, full-length pillows, a tennis ball attached to the back of nightwear, and electrical sensors with alarms that indicate change in position.\nObjectives\nTo compare the efficacy of positional therapy versus CPAP and positional therapy versus inactive control (sham intervention or no positional therapy intervention) in people with OSA.\nSearch methods\nWe identified studies from the Cochrane Airways' Specialised Register (including CENTRAL, MEDLINE, Embase, CINAHL, AHMED and PsycINFO), ClinicalTrials.gov, and the World Health Organization trials portal (ICTRP). It also contains results derived from handsearching of respiratory journals and abstract books of major annual meetings. We searched all databases from their inception to September 2018, with no restrictions on language of publication or publication type.\nSelection criteria\nWe included randomised controlled trials comparing positional therapy with CPAP and positional therapy with inactive control.\nData collection and analysis\nTwo review authors independently selected studies and extracted the data. We used a random-effects model in the meta-analysis to estimate mean differences and confidence intervals. We assessed certainty of evidence using the GRADE approach.\nMain results\nWe included eight studies. The studies randomised 323 participants into two types of interventions. The comparison between positional therapy and CPAP included 72 participants, while the comparison between positional therapy and inactive control included 251 participants. Three studies used supine vibration alarm devices, while five studies used physical positioning like specially designed pillows or semirigid backpacks.\nPositional therapy versus CPAP\nThe three studies included for this comparison were randomised cross-over trials. Two studies found that there was no difference in Epworth Sleepiness Scale (ESS) scores between CPAP and positional therapy. Two studies showed that CPAP produced a greater reduction in Apnoea-Hypopnoea Index (AHI) with a mean difference (MD) of 6.4 events per hour (95% CI 3.00 to 9.79; low-certainty evidence) compared to positional therapy. Subjective adherence, evaluated in one study, was found to be significantly greater with positional therapy (MD 2.5 hours per night, 95% CI 1.41 to 3.59; moderate-certainty evidence).\nIn terms of secondary outcomes, one study each reported quality-of-life indices and quality-of-sleep indices with no significant difference between the two groups. One study reported cognitive outcomes using multiple parameters and found no difference between the groups. There were insufficient data to comment on other secondary outcomes like respiratory disturbance index (RDI), and frequency and duration of nocturnal desaturation. None of the studies clearly reported adverse effects.\nPositional therapy versus inactive control\nThree studies of positional therapy versus no intervention were randomised cross-over trials, while two studies were parallel-arm studies. Data from two studies showed that positional therapy significantly improved ESS scores (MD −1.58, 95% CI −2.89 to −0.29; moderate-certainty evidence). Positional therapy showed a reduction in AHI compared with control (MD −7.38 events per hour, 95% CI −10.06 to −4.7; low-certainty evidence). One study reported adherence. The number of participants who continued to use the device at two months was no different between the two groups (odds ratio (OR) 0.80, 95% CI 0.33 to 1.94; low-certainty evidence). The same study reported adverse effects, the most common being pain in the back and chest, and sleep disturbance but there was no significant difference between the two groups in terms of device discontinuation (OR 1.25, 95% CI 0.5 to 3.03; low-certainty evidence). One study each reported quality-of-life indices and quality-of-sleep indices, with no significant difference between the two groups. One study reported cognitive outcome, and found no difference between the groups. There was insufficient evidence to comment on other secondary outcomes (RDI, frequency and duration of nocturnal desaturation).\nAuthors' conclusions\nThe review found that CPAP has a greater effect on improving AHI compared with positional therapy in positional OSA, while positional therapy was better than inactive control for improving ESS and AHI. Positional therapy may have better adherence than CPAP. There were no significant differences for other clinically relevant outcomes such as quality of life or cognitive function. All the studies were of short duration. We are unable to comment on the long-term effects of the therapies. This is important, as most of the quality-of-life outcomes will be evident only when the therapies are given over a longer period of time. The certainty of evidence was low to moderate.\n\nGiven the provided abstract, please respond to the following query: \"What is obstructive sleep apnoea?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Obstructive sleep apnoea (OSA) is sleep disorder where the walls of the throat relax and narrow during sleep. This causes pauses in the breathing. The pauses can last for a few seconds to a few minutes and can happen many times in the night. This disrupts the person's sleep. Bed partners can be disturbed by associated loud snoring, chocking and snorting sounds. People living with OSA can be very tired in the day or even fall to sleep. This can be dangerous. In children, sleep apnoea can cause problems at school or hyperactivity."
}
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query-laysum | 5280 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in Issue 6, 2012.\nEpilepsy is one of the most common chronic neurological disorders. Despite the plethora of antiepileptic drugs (AEDs) currently available, 30% of people continue having seizures. This group of people requires a more aggressive treatment, since monotherapy, the first choice scheme, fails to control seizures. Nevertheless, polytherapy often results in a number of unwanted effects, including neurological disturbances (somnolence, ataxia, dizziness), psychiatric and behavioural symptoms, and metabolic alteration (osteoporosis, inducement or inhibition of hepatic enzymes, etc.). The need for better tolerated AEDs is even more urgent in this group of people. Reports have suggested an antiepileptic role of melatonin with a good safety profile.\nObjectives\nTo assess the efficacy and tolerability of melatonin as add-on treatment for epilepsy.\nSearch methods\nFor the latest update, we searched the Cochrane Epilepsy Group's Specialized Register (12 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 12 January 2016), and MEDLINE (Ovid, 11 January 2016). We searched the bibliographies of any identified study for further references. We handsearched selected journals and conference proceedings. We applied no language restrictions. In addition, we contacted melatonin manufacturers (i.e. Nathura) and original investigators to identify any unpublished studies.\nSelection criteria\nRandomized controlled trials; double, single, or unblinded trials; parallel group or cross-over studies. People with epilepsy regardless of age and gender, including children and adults with disabilities. Administration of melatonin as add-on treatment to any AED(s) compared to add-on placebo or no add-on treatment.\nData collection and analysis\nReview authors independently selected trials for inclusion according to pre-defined criteria, extracted relevant data, and evaluated the methodological quality of trials. We assessed the following outcomes: at least 50% seizure reduction, seizure freedom, adverse events, and quality of life.\nMain results\nWe included six publications, with 125 participants (106 aged under 18 years). Two different comparisons were available: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Despite our primary intention, due to insufficient information on outcomes, we were unable to perform any meta-analyses, but summarized data narratively. Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, parallel, placebo-controlled trials. Only two studies provided the exact number of seizures during the trial compared to the baseline: none of the participants with seizures during the trial had a change in seizure frequency compared with the baseline. Two studies systematically evaluated adverse effects (worsening of headache was reported in a child with migraine under melatonin treatment). Only one study systematically evaluated quality of life, showing no statistically significant improvement in quality of life in the add-on melatonin group.\nAuthors' conclusions\nIncluded studies were of poor methodological quality, and did not systematically evaluate seizure frequency and adverse events, so that it was impossible to summarize data in a meta-analysis. It is not possible to draw any conclusion about the role of melatonin in reducing seizure frequency or improving quality of life in people with epilepsy.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Epilepsy is one of the most common long-term disorders of the nervous system, and despite several antiepileptic drugs being available, 30% of people continue having seizures (fits). Reports have suggested that melatonin can work in epilepsy with a good safety profile. Melatonin is produced by the body and is prescribed by doctors to treat sleep disorders and problems such as jet lag."
}
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query-laysum | 5281 | [
{
"role": "user",
"content": "Abstract: Background\nAn increasing body of evidence suggests that inflammation plays a key role in stroke, in particular stroke of atherosclerotic origin. Anti-inflammatory medications are a widely heterogeneous group of drugs that are used to suppress the innate inflammatory pathway and thus prevent persistent or recurrent inflammation. Anti-inflammatory agents have the potential to stabilise atherosclerotic plaques by impeding the inflammatory pathway. By targeting specific cytokines, the inflammatory pathway may be interrupted at various stages.\nObjectives\nTo assess the benefits and harms of anti-inflammatory medications plus standard care versus standard care with or without placebo for prevention of vascular events (stroke, myocardial infarction (MI), non-fatal cardiac arrest, unstable angina requiring revascularisation, vascular death) and all-cause mortality in people with a prior history of ischaemic stroke or transient ischaemic attack (TIA).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; last searched 29 May 2019); MEDLINE (1948 to 29 May 2019); Embase (1980 to 29 May 2019); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 29 May 2019); and Scopus (1995 to 29 May 2019). In an effort to identify additional published, unpublished, and ongoing trials, we searched several grey literature sources (last searched 30 May 2019). We incorporated all identified studies into the results section. We applied no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nWe considered randomised controlled trials (RCTs) and cluster-randomised controlled trials that evaluated anti-inflammatory medications for prevention of major cardiovascular events following ischaemic stroke or TIA.\nData collection and analysis\nTwo review authors independently assessed for inclusion titles and abstracts of studies identified by the search. Two review authors independently reviewed full-text articles for inclusion in this review. We planned to assess risk of bias and to apply the GRADE method.\nMain results\nWe identified no studies that met the inclusion criteria.\nAuthors' conclusions\nThere is currently a paucity of evidence on the use of anti-inflammatory medications for prevention of major cardiovascular events following ischaemic stroke or TIA. RCTs are needed to assess whether use of anti-inflammatory medications in this setting is beneficial.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No evidence and no studies were available."
}
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query-laysum | 5282 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review last published in Issue 7, 2019; it includes two additional studies.\nEpilepsy is a common neurological disease that affects approximately 1% of the UK population. Approximately one-third of these people continue to have seizures despite drug treatment. Pregabalin is one of the newer antiepileptic drugs that has been developed to improve outcomes. In this review we summarised the current evidence regarding pregabalin when used as an add-on treatment for drug-resistant focal epilepsy.\nObjectives\nTo assess the efficacy and tolerability of pregabalin when used as an add-on treatment for drug-resistant focal epilepsy.\nSearch methods\nFor the latest update we searched the following databases on 16 November 2020: Cochrane Register of Studies (CRS Web), and MEDLINE (Ovid, 1946 to 16 November 2020). CRS Web includes randomised or quasi-randomised, controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organisation International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialised Registers of Cochrane Review Groups, including Epilepsy.\nWe imposed no language restrictions. We contacted the manufacturers of pregabalin and authors in the field to identify any relevant unpublished studies.\nSelection criteria\nWe included randomised controlled trials comparing pregabalin with placebo or an alternative antiepileptic drug as an add-on for people of any age with drug-resistant focal epilepsy. Double-blind and single-blind trials were eligible for inclusion. The primary outcome was 50% or greater reduction in seizure frequency; secondary outcomes were seizure freedom, treatment withdrawal for any reason, treatment withdrawal due to adverse effects, and proportion of individuals experiencing adverse effects.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. Primary analyses were intention-to-treat (ITT). We presented summary risk ratios (RRs) and odds ratios (ORs) with 95% confidence intervals (CIs). We evaluated dose response in regression models. We carried out a risk of bias assessment for each included study using the Cochrane risk of bias tool and assessed the overall certainty of evidence using the GRADE approach.\nMain results\nWe included 11 randomised controlled trials (3949 participants). Nine trials compared pregabalin to placebo. For the primary outcome, participants randomised to pregabalin were significantly more likely to attain a 50% or greater reduction in seizure frequency compared to placebo (RR 1.95, 95% CI 1.40 to 2.72, 9 trials, 2663 participants, low-certainty evidence). The odds of response doubled with an increase in dose from 300 mg/day to 600 mg/day (OR 1.99, 95% CI 1.74 to 2.28), indicating a dose-response relationship. Pregabalin was significantly associated with seizure freedom (RR 3.94, 95% CI 1.50 to 10.37, 4 trials, 1125 participants, moderate-certainty evidence). Participants were significantly more likely to withdraw from pregabalin treatment than placebo for any reason (RR 1.33, 95% CI 1.10 to 1.60; 9 trials, 2663 participants; moderate-certainty evidence) and for adverse effects (RR 2.60, 95% CI 1.86 to 3.64; 9 trials, 2663 participants; moderate-certainty evidence).\nThree trials compared pregabalin to three active-control drugs: lamotrigine, levetiracetam and gabapentin. Participants allocated to pregabalin were significantly more likely to achieve a 50% or greater reduction in seizure frequency than those allocated to lamotrigine (RR 1.47, 95% CI 1.03 to 2.12; 1 trial, 293 participants) but not those allocated to levetiracetam (RR 0.94, 95% CI 0.80 to 1.11; 1 trial, 509 participants) or gabapentin (RR 0.96, 95% CI 0.82 to 1.12; 1 trial, 484 participants). We found no significant differences between pregabalin and lamotrigine for seizure freedom (RR 1.39, 95% CI 0.40 to 4.83). However, significantly fewer participants achieved seizure freedom with add-on pregabalin compared to levetiracetam (RR 0.50, 95% CI 0.30 to 0.85). No data were reported for this outcome for pregabalin versus gabapentin. We detected no significant differences in treatment withdrawal rate for any reason or due to adverse effects, specifically, during either pooled analysis or subgroup analysis. Ataxia, dizziness, somnolence, weight gain, headache and fatigue were significantly associated with pregabalin than in active control.\nWe rated the overall risk of bias in the included studies as low or unclear due to the possibility of publication bias and lack of methodological details provided. We assessed all the studies to be at a high risk of funding bias as they were all sponsored by Pfizer. We rated the certainty of the evidence as very low to moderate using the GRADE approach.\nAuthors' conclusions\nFor people with drug-resistant focal epilepsy, pregabalin when used as an add-on treatment was significantly more effective than placebo at producing a 50% or greater seizure reduction and seizure freedom. Results demonstrated efficacy for doses from 150 mg/day to 600 mg/day, with increasing effectiveness at 600 mg doses, although there were issues with tolerability at higher doses. However, the trials included in this review were of short duration, and longer-term trials are needed to inform clinical decision-making. This review focused on the use of pregabalin in drug-resistant focal epilepsy, and the results cannot be generalised to add-on treatment for generalised epilepsies. Likewise, no inference can be made about the effects of pregabalin when used as monotherapy.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review examined data from eleven trials, including a total of 3949 participants. Study participants were assigned using a random method to take pregabalin, placebo, or another antiepileptic drug in addition to their usual antiepileptic drugs."
}
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query-laysum | 5283 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 30% of hospitalised older adults experience hospital-associated functional decline. Exercise interventions that promote in-hospital activity may prevent deconditioning and thereby maintain physical function during hospitalisation. This is an update of a Cochrane Review first published in 2007.\nObjectives\nTo evaluate the benefits and harms of exercise interventions for acutely hospitalised older medical inpatients on functional ability, quality of life (QoL), participant global assessment of success and adverse events compared to usual care or a sham-control intervention.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was May 2021.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials evaluating an in-hospital exercise intervention in people aged 65 years or older admitted to hospital with a general medical condition. We excluded people admitted for elective reasons or surgery.\nData collection and analysis\nWe used standard Cochrane methods. Our major outcomes were 1. independence with activities of daily living; 2. functional mobility; 3. new incidence of delirium during hospitalisation; 4. QoL; 5. number of falls during hospitalisation; 6. medical deterioration during hospitalisation and 7. participant global assessment of success. Our minor outcomes were 8. death during hospitalisation; 9. musculoskeletal injuries during hospitalisation; 10. hospital length of stay; 11. new institutionalisation at hospital discharge; 12. hospital readmission and 13. walking performance. We used GRADE to assess certainty of evidence for each major outcome.\nWe categorised exercise interventions as: rehabilitation-related activities (interventions designed to increase physical activity or functional recovery, but did not follow a specified exercise protocol); structured exercise (interventions that included an exercise intervention protocol but did not include progressive resistance training); and progressive resistance exercise (interventions that included an element of progressive resistance training).\nMain results\nWe included 24 studies (nine rehabilitation-related activity interventions, six structured exercise interventions and nine progressive resistance exercise interventions) with 7511 participants. All studies compared exercise interventions to usual care; two studies, in addition to usual care, used sham interventions. Mean ages ranged from 73 to 88 years, and 58% of participants were women.\nSeveral studies were at high risk of bias. The most common domain assessed at high risk of bias was measurement of the outcome, and five studies (21%) were at high risk of bias arising from the randomisation process.\nExercise may have no clinically important effect on independence in activities of daily living at discharge from hospital compared to controls (16 studies, 5174 participants; low-certainty evidence). Five studies used the Barthel Index (scale: 0 to 100, higher scores representing greater independence). Mean scores at discharge in the control groups ranged from 42 to 96 points, and independence in activities of daily living was 1.8 points better (0.43 worse to 4.12 better) with exercise compared to controls. The minimally clinical important difference (MCID) is estimated to be 11 points.\nWe are uncertain regarding the effect of exercise on functional mobility at discharge from the hospital compared to controls (8 studies, 2369 participants; very low-certainty evidence). Three studies used the Short Physical Performance Battery (SPPB) (scale: 0 to 12, higher scores representing better function) to measure functional mobility. Mean scores at discharge in the control groups ranged from 3.7 to 4.9 points on the SPPB, and the estimated effect of the exercise interventions was 0.78 points better (0.02 worse to 1.57 better). A change of 1 point on the SPPB represents an MCID.\nWe are uncertain regarding the effect of exercise on the incidence of delirium during hospitalisation compared to controls (7 trials, 2088 participants; very low-certainty evidence). The incidence of delirium during hospitalisation was 88/1091 (81 per 1000) in the control group compared with 70/997 (73 per 1000; range 47 to 114) in the exercise group (RR 0.90, 95% CI 0.58 to 1.41).\nExercise interventions may result in a small clinically unimportant improvement in QoL at discharge from the hospital compared to controls (4 studies, 875 participants; low-certainty evidence). Mean QoL on the EuroQol 5 Dimensions (EQ-5D) visual analogue scale (VAS) (scale: 0 to 100, higher scores representing better QoL) ranged between 48.9 and 64.7 in the control group at discharge from the hospital, and QoL was 6.04 points better (0.9 better to 11.18 better) with exercise. A change of 10 points on the EQ-5D VAS represents an MCID.\nNo studies measured participant global assessment of success.\nExercise interventions did not affect the risk of falls during hospitalisation (moderate-certainty evidence). The incidence of falls was 31/899 (34 per 1000) in the control group compared with 31/888 (34 per 1000; range 20 to 57) in the exercise group (RR 0.99, 95% CI 0.59 to 1.65).\nWe are uncertain regarding the effect of exercise on the incidence of medical deterioration during hospitalisation (very low-certainty evidence). The incidence of medical deterioration in the control group was 101/1417 (71 per 1000) compared with 96/1313 (73 per 1000; range 44 to 120) in the exercise group (RR 1.02, 95% CI 0.62 to 1.68).\nSubgroup analyses by different intervention categories and by the use of a sham intervention were not meaningfully different from the main analyses.\nAuthors' conclusions\nExercise may make little difference to independence in activities of daily living or QoL, but probably does not result in more falls in older medical inpatients. We are uncertain about the effect of exercise on functional mobility, incidence of delirium and medical deterioration. Certainty of evidence was limited by risk of bias and inconsistency. Future primary research on the effect of exercise on acute hospitalisation could focus on more consistent and uniform reporting of participant's characteristics including their baseline level of functional ability, as well as exercise dose, intensity and adherence that may provide an insight into the reasons for the observed inconsistencies in findings.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Cochrane Review is current to May 2021."
}
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query-laysum | 5284 | [
{
"role": "user",
"content": "Abstract: Background\nParacetamol (acetaminophen) is the most widely used non-prescription analgesic in the world. Paracetamol is commonly taken in overdose either deliberately or unintentionally. In high-income countries, paracetamol toxicity is a common cause of acute liver injury. There are various interventions to treat paracetamol poisoning, depending on the clinical status of the person. These interventions include inhibiting the absorption of paracetamol from the gastrointestinal tract (decontamination), removal of paracetamol from the vascular system, and antidotes to prevent the formation of, or to detoxify, metabolites.\nObjectives\nTo assess the benefits and harms of interventions for paracetamol overdosage irrespective of the cause of the overdose.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register (January 2017), CENTRAL (2016, Issue 11), MEDLINE (1946 to January 2017), Embase (1974 to January 2017), and Science Citation Index Expanded (1900 to January 2017). We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov database (US National Institute of Health) for any ongoing or completed trials (January 2017). We examined the reference lists of relevant papers identified by the search and other published reviews.\nSelection criteria\nRandomised clinical trials assessing benefits and harms of interventions in people who have ingested a paracetamol overdose. The interventions could have been gastric lavage, ipecacuanha, or activated charcoal, or various extracorporeal treatments, or antidotes. The interventions could have been compared with placebo, no intervention, or to each other in differing regimens.\nData collection and analysis\nTwo review authors independently extracted data from the included trials. We used fixed-effect and random-effects Peto odds ratios (OR) with 95% confidence intervals (CI) for analysis of the review outcomes. We used the Cochrane 'Risk of bias' tool to assess the risks of bias (i.e. systematic errors leading to overestimation of benefits and underestimation of harms). We used Trial Sequential Analysis to control risks of random errors (i.e. play of chance) and GRADE to assess the quality of the evidence and constructed 'Summary of findings' tables using GRADE software.\nMain results\nWe identified 11 randomised clinical trials (of which one acetylcysteine trial was abandoned due to low numbers recruited), assessing several different interventions in 700 participants. The variety of interventions studied included decontamination, extracorporeal measures, and antidotes to detoxify paracetamol's toxic metabolite; which included methionine, cysteamine, dimercaprol, or acetylcysteine. There were no randomised clinical trials of agents that inhibit cytochrome P-450 to decrease the activation of the toxic metabolite N-acetyl-p-benzoquinone imine.\nOf the 11 trials, only two had two common outcomes, and hence, we could only meta-analyse two comparisons. Each of the remaining comparisons included outcome data from one trial only and hence their results are presented as described in the trials. All trial analyses lack power to access efficacy. Furthermore, all the trials were at high risk of bias. Accordingly, the quality of evidence was low or very low for all comparisons. Interventions that prevent absorption, such as gastric lavage, ipecacuanha, or activated charcoal were compared with placebo or no intervention and with each other in one four-armed randomised clinical trial involving 60 participants with an uncertain randomisation procedure and hence very low quality. The trial presented results on lowering plasma paracetamol levels. Activated charcoal seemed to reduce the absorption of paracetamol, but the clinical benefits were unclear. Activated charcoal seemed to have the best risk:benefit ratio among gastric lavage, ipecacuanha, or supportive treatment if given within four hours of ingestion. There seemed to be no difference between gastric lavage and ipecacuanha, but gastric lavage and ipecacuanha seemed more effective than no treatment (very low quality of evidence). Extracorporeal interventions included charcoal haemoperfusion compared with conventional treatment (supportive care including gastric lavage, intravenous fluids, and fresh frozen plasma) in one trial with 16 participants. The mean cumulative amount of paracetamol removed was 1.4 g. One participant from the haemoperfusion group who had ingested 135 g of paracetamol, died. There were no deaths in the conventional treatment group. Accordingly, we found no benefit of charcoal haemoperfusion (very low quality of evidence). Acetylcysteine appeared superior to placebo and had fewer adverse effects when compared with dimercaprol or cysteamine. Acetylcysteine superiority to methionine was unproven. One small trial (low quality evidence) found that acetylcysteine may reduce mortality in people with fulminant hepatic failure (Peto OR 0.29, 95% CI 0.09 to 0.94). The most recent randomised clinical trials studied different acetylcysteine regimens, with the primary outcome being adverse events. It was unclear which acetylcysteine treatment protocol offered the best efficacy, as most trials were underpowered to look at this outcome. One trial showed that a modified 12-hour acetylcysteine regimen with a two-hour acetylcysteine 100 mg/kg bodyweight loading dose was associated with significantly fewer adverse reactions compared with the traditional three-bag 20.25-hour regimen (low quality of evidence). All Trial Sequential Analyses showed lack of sufficient power. Children were not included in the majority of trials. Hence, the evidence pertains only to adults.\nAuthors' conclusions\nThese results highlight the paucity of randomised clinical trials comparing different interventions for paracetamol overdose and their routes of administration and the low or very low level quality of the evidence that is available. Evidence from a single trial found activated charcoal seemed the best choice to reduce absorption of paracetamol. Acetylcysteine should be given to people at risk of toxicity including people presenting with liver failure. Further randomised clinical trials with low risk of bias and adequate number of participants are required to determine which regimen results in the fewest adverse effects with the best efficacy. Current management of paracetamol poisoning worldwide involves the administration of intravenous or oral acetylcysteine which is based mainly on observational studies. Results from these observational studies indicate that treatment with acetylcysteine seems to result in a decrease in morbidity and mortality, However, further evidence from randomised clinical trials comparing different treatments are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "randomised clinical trials (studies where people are randomly put into one of two or more treatment groups) where participants had come to medical attention because they had taken a paracetamol overdose, intentionally or by accident, regardless of the amount of paracetamol taken or the age, sex, or other medical conditions of the person involved.\nThere are many different interventions that can be used to try to treat people with paracetamol poisoning. These interventions include decreasing the absorption of the paracetamol ingested and hence decreasing the amount absorbed into the bloodstream. The agents include activated charcoal (that binds paracetamol together in the stomach), gastric lavage (stomach washout to remove as much paracetamol as possible), or ipecacuanha (a syrup that is swallowed and causes vomiting (being sick)). Paracetamol once absorbed into the bloodstream goes to the liver where the majority is broken down to harmless products. However, a small amount of the medicine is converted into a toxic product that the liver can normally handle but, when large amounts of paracetamol are taken, the liver is overwhelmed. As a consequence, the toxic product can damage the liver leading to liver failure, kidney failure, and in some cases death. Other interventions to treat paracetamol poisoning include medicines (antidotes) that may decrease the amount of the toxic products (such as a medicine called cimetidine) or breakdown the toxic products (including medicines called methionine, cysteamine, dimercaprol, or acetylcysteine). Finally, attempts can be made to remove paracetamol and its toxic products from the bloodstream using special blood cleansing equipment. All these treatments were examined.\nWe found 11 randomised clinical trials with 700 participants. Most of these trials looked at different treatments."
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query-laysum | 5285 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal abstinence syndrome (NAS) due to opioid withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss, seizures and neurodevelopmental problems.\nObjectives\nTo assess the effectiveness and safety of using an opioid for treatment of NAS due to withdrawal from opioids in newborn infants.\nSearch methods\nWe ran an updated search on 17 September 2020 in CENTRAL via Cochrane Register of Studies Web and MEDLINE via Ovid. We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for eligible trials.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi- and cluster-RCTs which enrolled infants born to mothers with opioid dependence and who were experiencing NAS requiring treatment with an opioid.\nData collection and analysis\nThree review authors independently assessed trial eligibility and risk of bias, and independently extracted data. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included 16 trials (1110 infants) with NAS secondary to maternal opioid use in pregnancy. Seven studies at low risk of bias were included in sensitivity analysis.\nOpioid versus no treatment / usual care: a single trial (80 infants) of morphine and supportive care versus supportive care alone reported no difference in treatment failure (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.41 to 4.07; very low certainty evidence). No infant had a seizure. The trial did not report mortality, neurodevelopmental disability and adverse events. Morphine increased days hospitalisation (mean difference (MD) 15.00, 95% CI 8.86 to 21.14; very low certainty evidence) and treatment (MD 12.50, 95% CI 7.52 to 17.48; very low certainty evidence), but decreased days to regain birthweight (MD -2.80, 95% CI -5.33 to -0.27) and duration (minutes) of supportive care each day (MD -197.20, 95% CI -274.15 to -120.25).\nMorphine versus methadone: there was no difference in treatment failure (RR 1.59, 95% CI 0.95 to 2.67; 2 studies, 147 infants; low certainty evidence). Seizures, neonatal or infant mortality and neurodevelopmental disability were not reported. A single study reported no difference in days hospitalisation (MD 1.40, 95% CI -3.08 to 5.88; 116 infants; low certainty evidence), whereas data from two studies found an increase in days treatment (MD 2.71, 95% CI 0.22 to 5.21; 147 infants; low certainty) for infants treated with morphine. A single study reported no difference in breastfeeding, adverse events, or out of home placement.\nMorphine versus sublingual buprenorphine: there was no difference in treatment failure (RR 0.79, 95% CI 0.36 to 1.74; 3 studies, 113 infants; very low certainty evidence). Neonatal or infant mortality and neurodevelopmental disability were not reported. There was moderate certainty evidence of an increase in days hospitalisation (MD 11.45, 95% CI 5.89 to 17.01; 3 studies, 113 infants), and days treatment (MD 12.79, 95% CI 7.57 to 18.00; 3 studies, 112 infants) for infants treated with morphine. A single adverse event (seizure) was reported in infants exposed to buprenorphine.\nMorphine versus diluted tincture of opium (DTO): a single study (33 infants) reported no difference in days hospitalisation, days treatment or weight gain (low certainty evidence).\nOpioid versus clonidine: a single study (31 infants) reported no infant with treatment failure in either group. This study did not report seizures, neonatal or infant mortality and neurodevelopmental disability. There was low certainty evidence for no difference in days hospitalisation or days treatment. This study did not report adverse events.\nOpioid versus diazepam: there was a reduction in treatment failure from use of an opioid (RR 0.43, 95% CI 0.23 to 0.80; 2 studies, 86 infants; low certainty evidence). Seizures, neonatal or infant mortality and neurodevelopmental disability were not reported. A single study of 34 infants comparing methadone versus diazepam reported no difference in days hospitalisation or days treatment (very low certainty evidence). Adverse events were not reported.\nOpioid versus phenobarbital: there was a reduction in treatment failure from use of an opioid (RR 0.51, 95% CI 0.35 to 0.74; 6 studies, 458 infants; moderate certainty evidence). Subgroup analysis found a reduction in treatment failure in trials titrating morphine to ≧ 0.5 mg/kg/day (RR 0.21, 95% CI 0.10 to 0.45; 3 studies, 230 infants), whereas a single study using morphine < 0.5 mg/kg/day reported no difference compared to use of phenobarbital (subgroup difference P = 0.05). Neonatal or infant mortality and neurodevelopmental disability were not reported. A single study (111 infants) of paregoric versus phenobarbital reported seven infants with seizures in the phenobarbital group, whereas no seizures were reported in two studies (170 infants) comparing morphine to phenobarbital. There was no difference in days hospitalisation or days treatment. A single study (96 infants) reported no adverse events in either group.\nOpioid versus chlorpromazine: there was a reduction in treatment failure from use of morphine versus chlorpromazine (RR 0.08, 95% CI 0.01 to 0.62; 1 study, 90 infants; moderate certainty evidence). No seizures were reported in either group. There was low certainty evidence for no difference in days treatment. This trial reported no adverse events in either group.\nNone of the included studies reported time to control of NAS. Data for duration and severity of NAS were limited, and we were unable to use these data in quantitative synthesis.\nAuthors' conclusions\nCompared to supportive care alone, the addition of an opioid may increase duration of hospitalisation and treatment, but may reduce days to regain birthweight and the duration of supportive care each day. Use of an opioid may reduce treatment failure compared to phenobarbital, diazepam or chlorpromazine. Use of an opioid may have little or no effect on duration of hospitalisation or treatment compared to use of phenobarbital, diazepam or chlorpromazine. The type of opioid used may have little or no effect on the treatment failure rate. Use of buprenorphine probably reduces duration of hospitalisation and treatment compared to morphine, but there are no data for time to control NAS with buprenorphine, and insufficient evidence to determine safety. There is insufficient evidence to determine the effectiveness and safety of clonidine.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Use of opioids (prescribed or illicit) by pregnant women may result in their newborn infant experiencing withdrawal symptoms, collectively referred to as neonatal abstinence syndrome (NAS). These symptoms may result in disruption of the mother-infant relationship, sleeping and feeding difficulties, weight loss and seizures. Treatments for newborn infants that are used to ameliorate NAS and reduce complications include supportive care treatments (such as a pacifier, swaddling, close wrapping, small frequent feeds, close skin contact by carrying in a sling, and other methods), prescription of opioids or sedatives, or both."
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query-laysum | 5286 | [
{
"role": "user",
"content": "Abstract: Background\nOvulation induction with follicle stimulating hormone (FSH) is a second-line treatment in women with polycystic ovary syndrome (PCOS) who do not ovulate or conceive on clomiphene citrate.\nObjectives\nTo compare the effectiveness and safety of gonadotrophins as a second-line treatment for ovulation induction in women with clomiphene citrate-resistant polycystic ovary syndrome (PCOS), and women who do not ovulate or conceive after clomiphene citrate.\nSearch methods\nIn January 2018, we searched the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, the World Health Organisation clinical trials register, Clinicaltrials.gov, LILACs, and PubMed databases, and Google Scholar. We checked references of in all obtained studies. We had no language restrictions.\nSelection criteria\nAll randomised controlled trials reporting data on clinical outcomes in women with PCOS who did not ovulate or conceive on clomiphene citrate, and undergoing ovulation induction with urinary-derived gonadotrophins, including urofollitropin (uFSH) in purified FSH (FSH-P) or highly purified FSH (FSH-HP) form, human menopausal gonadotropin (HMG) and highly purified human menopausal gonadotrophin (HP-HMG), or recombinant FSH (rFSH), or continuing clomiphene citrate. We included trials reporting on ovulation induction followed by intercourse or intrauterine insemination. We excluded studies that described co-treatment with clomiphene citrate, metformin, luteinizing hormone, or letrozole.\nData collection and analysis\nThree review authors (NW, EK, and MvW) independently selected studies for inclusion, assessed risk of bias, and extracted study data. Primary outcomes were live birth rate per woman and multiple pregnancy per woman. Secondary outcomes were clinical pregnancy, miscarriage, incidence of ovarian hyperstimulation syndrome (OHSS) per woman, total gonadotrophin dose, and total duration of stimulation per woman. We combined data using a fixed-effect model to calculate the risk ratio (RR). We summarised the overall quality of evidence for the main outcomes using GRADE criteria.\nMain results\nThe review included 15 trials with 2387 women. Ten trials compared rFSH with urinary-derived gonadotrophins (three compared rFSH with human menopausal gonadotrophin, and seven compared rFSH with FSH-HP), four trials compared FSH-P with HMG. We found no trials that compared FSH-HP with FSH-P. One trial compared FSH with continued clomiphene citrate.\nRecombinant FSH (rFSH) versus urinary-derived gonadotrophins\nThere may be little or no difference in the birth rate between rFSH and urinary-derived gonadotrophins (RR 1.21, 95% confidence interval (CI) 0.83 to 1.78; five trials, N = 505; I² = 9%; low-quality evidence). This suggests that for the observed average live birth per woman who used urinary-derived FSH of 16%, the chance of live birth with rFSH is between 13% and 28%. There may also be little or no difference between groups in incidence of multiple pregnancy (RR 0.86, 95% CI 0.46 to 1.61; eight trials, N = 1368; I² = 0%; low-quality evidence), clinical pregnancy rate (RR 1.05, 95% CI 0.88 to 1.27; eight trials, N = 1330; I² = 0; low-quality evidence), or miscarriage rate (RR 1.20, 95% CI 0.71 to 2.04; seven trials, N = 970; I² = 0; low-quality evidence). We are uncertain whether rFSH reduces the incidence of OHSS (RR 1.48, 95% CI 0.82 to 2.65, ten trials, n=1565, I² = 0%, very low-quality evidence).\nHuman menopausal gonadotrophin (HMG) or HP-HMG versus uFSH\nWhen compared to uFSH, we are uncertain whether HMG or HP-HMG improves live birth rate (RR 1.28, 95% CI 0.65 to 2.52; three trials, N = 138; I² = 0%; very low quality evidence), or reduces multiple pregnancy rate (RR 2.13, 95% CI 0.51 to 8.91; four trials, N = 161; I² = 0%; very low quality evidence). We are also uncertain whether HMG or HP-HMG improves clinical pregnancy rate (RR 1.31, 95% CI 0.66 to 2.59; three trials, N = 102; I² = 0; very low quality evidence), reduces miscarriage rate (RR 0.33, 95% CI 0.06 to 1.97; two trials, N = 98; I² = 0%; very low quality evidence), or reduces the incidence of OHSS (RR 7.07, 95% CI 0.42 to 117.81; two trials, N = 53; very low quality evidence) when compared to uFSH.\nGonadotrophins versus continued clomiphene citrate\nGonadotrophins resulted in more live births than continued clomiphene citrate (RR 1.24, 95% CI 1.05 to 1.46; one trial, N = 661; I² = 0%; moderate-quality evidence). This suggests that for a woman with a live birth rate of 41% with continued clomiphene citrate, the live birth rate with FSH was between 43% and 60%. There is probably little or no difference in the incidence of multiple pregnancy between treatments (RR 0.89, 95% CI 0.33 to 2.44; one trial, N = 661; I² = 0%; moderate-quality evidence). Gonadotrophins resulted in more clinical pregnancies than continued clomiphene citrate (RR 1.31, 95% CI 1.13 to 1.52; one trial, N = 661; I² = 0%; moderate-quality evidence), and more miscarriages (RR 2.23, 95% CI 1.11 to 4.47; one trial, N = 661; I² = 0%; moderate-quality evidence). None of the women developed OHSS.\nAuthors' conclusions\nThere may be little or no difference in live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate between urinary-derived gonadotrophins and recombinant follicle stimulating hormone in women with polycystic ovary syndrome. For human menopausal gonadotropin or highly purified human menopausal gonadotrophin versus urinary follicle stimulating hormone we are uncertain whether one or the other improves or lowers live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate. We are uncertain whether any of the interventions reduce the incidence of ovarian hyperstimulation syndrome. We suggest weighing costs and convenience in the decision to use one or the other gonadotrophin. In women with clomiphene citrate failure, gonadotrophins resulted in more live births than continued clomiphene citrate without increasing multiple pregnancies.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To compare the effectiveness and safety of gonadotrophins, hormones that regulate the reproductive system, as a second-line treatment to stimulate ovulation in women with PCOS who do not ovulate or conceive on clomiphene citrate."
}
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query-laysum | 5287 | [
{
"role": "user",
"content": "Abstract: Background\nCritically ill people are at increased risk of malnutrition. Acute and chronic illness, trauma and inflammation induce stress-related catabolism, and drug-induced adverse effects may reduce appetite or increase nausea and vomiting. In addition, patient management in the intensive care unit (ICU) may also interrupt feeding routines. Methods to deliver nutritional requirements include provision of enteral nutrition (EN), or parenteral nutrition (PN), or a combination of both (EN and PN). However, each method is problematic. This review aimed to determine the route of delivery that optimizes uptake of nutrition.\nObjectives\nTo compare the effects of enteral versus parenteral methods of nutrition, and the effects of enteral versus a combination of enteral and parenteral methods of nutrition, among critically ill adults, in terms of mortality, number of ICU-free days up to day 28, and adverse events.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase on 3 October 2017. We searched clinical trials registries and grey literature, and handsearched reference lists of included studies and related reviews.\nSelection criteria\nWe included randomized controlled studies (RCTs) and quasi-randomized studies comparing EN given to adults in the ICU versus PN or versus EN and PN. We included participants that were trauma, emergency, and postsurgical patients in the ICU.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias. We assessed the certainty of evidence with GRADE.\nMain results\nWe included 25 studies with 8816 participants; 23 studies were RCTs and two were quasi-randomized studies. All included participants were critically ill in the ICU with a wide range of diagnoses; mechanical ventilation status between study participants varied. We identified 11 studies awaiting classification for which we were unable to assess eligibility, and two ongoing studies.\nSeventeen studies compared EN versus PN, six compared EN versus EN and PN, two were multi-arm studies comparing EN versus PN versus EN and PN. Most studies reported randomization and allocation concealment inadequately. Most studies reported no methods to blind personnel or outcome assessors to nutrition groups; one study used adequate methods to reduce risk of performance bias.\nEnteral nutrition versus parenteral nutrition\nWe found that one feeding route rather than the other (EN or PN) may make little or no difference to mortality in hospital (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.80 to 1.77; 361 participants; 6 studies; low-certainty evidence), or mortality within 30 days (RR 1.02, 95% CI 0.92 to 1.13; 3148 participants; 11 studies; low-certainty evidence). It is uncertain whether one feeding route rather than the other reduces mortality within 90 days because the certainty of the evidence is very low (RR 1.06, 95% CI 0.95 to 1.17; 2461 participants; 3 studies). One study reported mortality at one to four months and we did not combine this in the analysis; we reported this data as mortality within 180 days and it is uncertain whether EN or PN affects the number of deaths within 180 days because the certainty of the evidence is very low (RR 0.33, 95% CI 0.04 to 2.97; 46 participants).\nNo studies reported number of ICU-free days up to day 28, and one study reported number of ventilator-free days up to day 28 and it is uncertain whether one feeding route rather than the other reduces the number of ventilator-free days up to day 28 because the certainty of the evidence is very low (mean difference, inverse variance, 0.00, 95% CI -0.97 to 0.97; 2388 participants).\nWe combined data for adverse events reported by more than one study. It is uncertain whether EN or PN affects aspiration because the certainty of the evidence is very low (RR 1.53, 95% CI 0.46 to 5.03; 2437 participants; 2 studies), and we found that one feeding route rather than the other may make little or no difference to pneumonia (RR 1.10, 95% CI 0.82 to 1.48; 415 participants; 7 studies; low-certainty evidence). We found that EN may reduce sepsis (RR 0.59, 95% CI 0.37 to 0.95; 361 participants; 7 studies; low-certainty evidence), and it is uncertain whether PN reduces vomiting because the certainty of the evidence is very low (RR 3.42, 95% CI 1.15 to 10.16; 2525 participants; 3 studies).\nEnteral nutrition versus enteral nutrition and parenteral nutrition\nWe found that one feeding regimen rather than another (EN or combined EN or PN) may make little or no difference to mortality in hospital (RR 0.99, 95% CI 0.84 to 1.16; 5111 participants; 5 studies; low-certainty evidence), and at 90 days (RR 1.00, 95% CI 0.86 to 1.18; 4760 participants; 2 studies; low-certainty evidence). It is uncertain whether combined EN and PN leads to fewer deaths at 30 days because the certainty of the evidence is very low (RR 1.64, 95% CI 1.06 to 2.54; 409 participants; 3 studies). It is uncertain whether one feeding regimen rather than another reduces mortality within 180 days because the certainty of the evidence is very low (RR 1.00, 95% CI 0.65 to 1.55; 120 participants; 1 study).\nNo studies reported number of ICU-free days or ventilator-free days up to day 28. It is uncertain whether either feeding method reduces pneumonia because the certainty of the evidence is very low (RR 1.40, 95% CI 0.91 to 2.15; 205 participants; 2 studies). No studies reported aspiration, sepsis, or vomiting.\nAuthors' conclusions\nWe found insufficient evidence to determine whether EN is better or worse than PN, or than combined EN and PN for mortality in hospital, at 90 days and at 180 days, and on the number of ventilator-free days and adverse events. We found fewer deaths at 30 days when studies gave combined EN and PN, and reduced sepsis for EN rather than PN. We found no studies that reported number of ICU-free days up to day 28. Certainty of the evidence for all outcomes is either low or very low. The 11 studies awaiting classification may alter the conclusions of the review once assessed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Critically ill adults in the intensive care unit (ICU) are at an increased risk of malnutrition because the body responds to serious illness or injury by increasing the metabolic rate. Also, the person's feeding routine may be disrupted because they are unconscious or too ill to feed themselves or eat normally. This means alternative ways to ensure people receive adequate nutrition must be used. People may be given artificial nutrition in three ways: enteral feeding (through a tube placed into the stomach or small intestine; parenteral feeding (through a tube inserted into a vein whereby nutrients enter the bloodstream directly); or by a combination of both routes. This review compared the effects of these routes."
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query-laysum | 5288 | [
{
"role": "user",
"content": "Abstract: Background\nProbiotics may be effective in reducing the duration of acute infectious diarrhoea.\nObjectives\nTo assess the effects of probiotics in proven or presumed acute infectious diarrhoea.\nSearch methods\nWe searched the trials register of the Cochrane Infectious Diseases Group, MEDLINE, and Embase from inception to 17 December 2019, as well as the Cochrane Controlled Trials Register (Issue 12, 2019), in the Cochrane Library, and reference lists from studies and reviews. We included additional studies identified during external review.\nSelection criteria\nRandomized controlled trials comparing a specified probiotic agent with a placebo or no probiotic in people with acute diarrhoea that is proven or presumed to be caused by an infectious agent.\nData collection and analysis\nTwo review authors independently applied inclusion criteria, assessed risk of bias, and extracted data. Primary outcomes were measures of diarrhoea duration (diarrhoea lasting ≥ 48 hours; duration of diarrhoea). Secondary outcomes were number of people hospitalized in community studies, duration of hospitalization in inpatient studies, diarrhoea lasting ≥ 14 days, and adverse events.\nMain results\nWe included 82 studies with a total of 12,127 participants. These studies included 11,526 children (age < 18 years) and 412 adults (three studies recruited 189 adults and children but did not specify numbers in each age group). No cluster-randomized trials were included. Studies varied in the definitions used for \"acute diarrhoea\" and \"end of the diarrhoeal illness\" and in the probiotic(s) tested. A total of 53 trials were undertaken in countries where both child and adult mortality was low or very low, and 26 where either child or adult mortality was high.\nRisk of bias was high or unclear in many studies, and there was marked statistical heterogeneity when findings for the primary outcomes were pooled in meta-analysis. Effect size was similar in the sensitivity analysis and marked heterogeneity persisted. Publication bias was demonstrated from funnel plots for the main outcomes.\nIn our main analysis of the primary outcomes in studies at low risk for all indices of risk of bias, no difference was detected between probiotic and control groups for the risk of diarrhoea lasting ≥ 48 hours (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.91 to 1.09; 2 trials, 1770 participants; moderate-certainty evidence); or for duration of diarrhoea (mean difference (MD) 8.64 hours shorter, 95% CI 29.4 hours shorter to 12.1 hours longer; 6 trials, 3058 participants; very low-certainty evidence).\nEffect size was similar and marked heterogeneity persisted in pre-specified subgroup analyses of the primary outcomes that included all studies. These included analyses limited to the probiotics Lactobacillus rhamnosus GG and Saccharomyces boulardii. In six trials (433 participants) of Lactobacillus reuteri, there was consistency amongst findings (I² = 0%), but risk of bias was present in all included studies. Heterogeneity also was not explained by types of participants (age, nutritional/socioeconomic status captured by mortality stratum, region of the world where studies were undertaken), diarrhoea in children caused by rotavirus, exposure to antibiotics, and the few studies of children who were also treated with zinc. In addition, there were no clear differences in effect size for the primary outcomes in post hoc analyses according to decade of publication of studies and whether or not trials had been registered.\nFor other outcomes, the duration of hospitalization in inpatient studies on average was shorter in probiotic groups than in control groups but there was marked heterogeneity between studies (I² = 96%; MD -18.03 hours, 95% CI -27.28 to -8.78, random-effects model: 24 trials, 4056 participants). No differences were detected between probiotic and control groups in the number of people with diarrhoea lasting ≥ 14 days (RR 0.49, 95% CI 0.16 to 1.53; 9 studies, 2928 participants) or in risk of hospitalization in community studies (RR 1.26, 95% CI 0.84 to 1.89; 6 studies, 2283 participants).\nNo serious adverse events were attributed to probiotics.\nAuthors' conclusions\nProbiotics probably make little or no difference to the number of people who have diarrhoea lasting 48 hours or longer, and we are uncertain whether probiotics reduce the duration of diarrhoea. This analysis is based on large trials with low risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Probiotics may not affect how long acute diarrhoea lasts. We do not know if they can shorten the time to recovery from diarrhoea. We need reliable evidence from further studies to determine whether probiotics help treat acute infectious diarrhoea."
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query-laysum | 5289 | [
{
"role": "user",
"content": "Abstract: Background\nAnterior cruciate ligament (ACL) tears are serious knee injuries that are frequently treated surgically in the form of arthroscopically assisted reconstruction with grafts from the patella or hamstrings tendons. We reviewed the evidence for the choice of arthroscopically assisted ACL reconstruction technique in terms of whether it should involve one incision (femoral tunnel drilled from inside the knee joint under arthroscopic visualisation) or two incisions (femoral tunnel drilled from outside to inside the knee joint).\nObjectives\nTo assess the effects (benefits and harms) of one-incision versus two-incision techniques for arthroscopically assisted ACL reconstruction in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Latin American and Caribbean Health Sciences (LILACS), the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, reference lists, and conference abstracts. The date of the search was 16 August 2017.\nSelection criteria\nRandomised and quasi-randomised controlled clinical trials evaluating one-incision versus two-incision techniques for arthroscopically assisted ACL reconstruction in adults.\nData collection and analysis\nTwo review authors independently searched and selected studies, and extracted data and assessed the risk of bias of the eligible studies. We undertook limited pooling of data using the fixed-effect model.\nMain results\nWe included five trials (four randomised and one quasi-randomised) evaluating a total of 320 participants who were mainly in their 20s. All participants underwent ACL reconstruction with patella tendon grafts. All five included trials were at a high risk of bias, particularly performance bias. Based on these limitations and the insufficiency of the available data resulting in imprecision of effect estimates, we judged the quality of the evidence as very low for all outcomes. This means that we are uncertain of the findings of the review.\nWe found very low-quality evidence of no clinically important differences between the two techniques in self reported knee function, measured using the Lysholm knee score (scale 0 to 100: best outcome), at short-term (3 months) (mean difference (MD) 2.73 favours one-incision technique, 95% confidence interval (CI) -2.70 to 8.15; 79 participants, 2 studies), intermediate-term (12 months) (MD -3.68 favours two-incision technique, 95% CI -6.61 to -0.75; 79 participants, 2 studies), and long-term follow-up. The data available for long-term follow-up (2 to 5 years) was expressed in terms of the numbers of participants with excellent Lysholm scores (90 points or more); we found no difference between the two groups (42/45 versus 36/40; risk ratio (RR) 1.04, 95% CI 0.91 to 1.18; 1 study). There were no data for quality of life measures or for overall numbers of participants incurring an adverse event. We found very low-quality evidence of little between-group differences in individual adverse events such as infection, knee stiffness, reoperation, and graft failure.\nWe found very low-quality evidence from one study (59 participants) of little difference between the two groups in activity levels measured using Tegner scores (scale 0 to 10: highest sport activity) at two years (MD -0.80 favours two-incision technique, 95% CI -1.90 to 0.30). There was very low-quality evidence from four studies of minimal between-group difference in the number of participants with normal or nearly normal objectively measured knee function (International Knee Documentation Committee objective assessment grading) at intermediate follow-up (means 12 to 28 months): 56/78 versus 63/89; RR 1.01, 95% CI 0.85 to 1.21; 167 participants).\nAuthors' conclusions\nThe very low-quality and often absent evidence means that we are uncertain whether one-incision arthroscopically assisted ACL reconstruction techniques yield better, worse, or equivalent results compared with two-incision techniques in terms of short-, intermediate-, or long-term subjective function, quality of life, adverse outcomes, activity levels, and objectively rated knee function. The evidence was available only for single-bundle ACL reconstruction using patella tendon grafts.\nWhen considering priorities for high-quality randomised trials on techniques for ACL reconstruction, it is important to note the insufficiency of the evidence available to inform this key comparison.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no differences between the two techniques in self reported knee function at around three months, 12 months, or between two and five years. There were no data for quality of life or for the overall number of participants incurring an adverse event. However, we found evidence of little between-group differences in individual adverse events such as infection, knee stiffness, and graft failure. There was evidence of little difference between the two groups in final activity levels or the numbers of participants with normal or nearly normal knee function assessed by clinicians at a year or more after surgery."
}
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query-laysum | 5290 | [
{
"role": "user",
"content": "Abstract: Background\nCongenital nasolacrimal duct obstruction (NLDO) is a common condition causing excessive tearing in the first year of life. Infants present with excessive tearing or mucoid discharge from the eyes due to blockage of the nasolacrimal duct system, which can result in maceration of the skin of the eyelids and local infections, such as conjunctivitis, that may require antibiotics. The incidence of nasolacrimal duct obstruction in early childhood ranges from 5% to 20% and often resolves without surgery. Treatment options for this condition are either conservative therapy, including observation (or deferred probing), massage of the lacrimal sac and antibiotics, or probing the nasolacrimal duct to open the membranous obstruction at the distal nasolacrimal duct. Probing may be performed without anesthesia in the office setting or under general anesthesia in the operating room. Probing may serve to resolve the symptoms by opening the membranous obstruction; however, it may not be successful if the obstruction is due to a bony protrusion of the inferior turbinate into the nasolacrimal duct or when the duct is edematous (swollen) due to infection such as dacryocystitis. Additionally, potential complications with probing include creation of a false passage and injury to the nasolacrimal duct, canaliculi and puncta, bleeding, laryngospasm, or aspiration.\nObjectives\nTo assess the effects of probing for congenital nasolacrimal duct obstruction.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2016, Issue 8); MEDLINE Ovid (1946 to 30 August 2016); Embase.com (1947 to 30 August 2016); PubMed (1948 to 30 August 2016); LILACS (Latin American and Caribbean Health Sciences Literature Database; 1982 to 30 August 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), last searched 14 August 2014; ClinicalTrials.gov (www.clinicaltrials.gov), searched 30 August 2016; and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en), searched 30 August 2016. We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared probing (office-based or hospital-based under general anesthesia) versus no (or deferred) probing or other interventions (observation alone, antibiotic drops only, or antibiotic drops plus massage of the nasolacrimal duct). We did not include studies that compared different probing techniques or probing compared with other surgical procedures. We included studies in children aged three weeks to four years who may have presented with tearing and conjunctivitis.\nData collection and analysis\nTwo review authors independently screened studies for inclusion and independently extracted data and assessed risk of bias for the included studies. We analyzed data using Review Manager software and evaluated the certainty of the evidence using GRADE.\nMain results\nWe identified two RCTs and no ongoing studies; one of the included RCTs was registered. The studies reported on 303 eyes of 242 participants who had unilateral or bilateral congenital nasolacrimal duct obstruction. For both included studies, the interventions compared were immediate office-based probing to remove the duct obstruction versus deferred probing, if needed, after 6 months of observation or once the child reached a certain age.\nThe primary outcome of the review, treatment success at 6 months, was reported partially in one study. Treatment success was not reported at this time point for all children in the immediate probing group; however, 77 of 117 (66%) eyes randomized to deferred probing had resolved without surgery 6 months after randomization and 40 (34%) eyes did not resolve without probing. For children who had unilateral NLDO, those randomized to immediate probing had treatment success more often than those who were randomized to deferred probing (RR 1.41, 95% CI 1.12 to 1.78; 163 children; moderate-certainty evidence). Treatment success for all children was assessed in the study at age 18 months; as an ad hoc analysis in the included study, results were presented separately for children with unilateral and bilateral NLDO (RR 1.13, 95% CI 0.99 to 1.28 and RR 0.86, 95% CI 0.70 to 1.06, respectively; very low-certainty evidence).\nIn the other small study (26 eyes of 22 children), more eyes that received immediate probing were cured within one month after surgery compared with eyes that were randomized to deferred probing and analyzed at age 15 months (RR 2.56, 95% CI 1.16 to 5.64). We considered the evidence to be low-certainty due to imprecision from the small study size and risk of bias concerns due to attrition bias.\nOne study reported on the number of children that required reoperation; however, these data were reported only for immediate probing group. Nine percent of children with unilateral NLDO and 13% with bilateral NLDO required secondary procedures.\nOne study reported cost-effectiveness of immediate probing versus deferred probing. The mean cost of treatment for immediate probing was less than for deferred probing; however, there is uncertainty as to whether there is a true cost difference (mean difference USD -139, 95% CI USD −377 to 94; moderate-certainty evidence).\nReported complications of the treatment were not serious. One study reported that there were no complications for any surgery and no serious adverse events, while the other study reported that bleeding from the punctum occurred in 20% of all probings.\nAuthors' conclusions\nThe effects and costs of immediate versus deferred probing for NLDO are uncertain. Children who have unilateral NLDO may have better success from immediate office probing, though few children have participated in these trials, and investigators examined outcomes at disparate time points. Determining whether to perform the procedure and its optimal timing will require additional studies with greater power and larger, well-run clinical trials to help our understanding of the comparison.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sometimes children are born with a blocked tear duct. The aim of this Cochrane Review was to find out whether it is better to immediately clear this blocked tear duct, using a probe, or to wait to see if the blockage clears on it's own. Cochrane review authors collected and analyzed all relevant studies to answer this question and found two studies."
}
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query-laysum | 5291 | [
{
"role": "user",
"content": "Abstract: Background\nDental plaque associated gingivitis is a reversible inflammatory condition caused by accumulation and persistence of microbial biofilms (dental plaque) on the teeth. It is characterised by redness and swelling of the gingivae (gums) and a tendency for the gingivae to bleed easily. In susceptible individuals, gingivitis may lead to periodontitis and loss of the soft tissue and bony support for the tooth. It is thought that chlorhexidine mouthrinse may reduce the build-up of plaque thereby reducing gingivitis.\nObjectives\nTo assess the effectiveness of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for the control of gingivitis and plaque compared to mechanical oral hygiene procedures alone or mechanical oral hygiene procedures plus placebo/control mouthrinse. Mechanical oral hygiene procedures were toothbrushing with/without the use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment.\nTo determine whether the effect of chlorhexidine mouthrinse is influenced by chlorhexidine concentration, or frequency of rinsing (once/day versus twice/day).\nTo report and describe any adverse effects associated with chlorhexidine mouthrinse use from included trials.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 28 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8) in the Cochrane Library (searched 28 September 2016); MEDLINE Ovid (1946 to 28 September 2016); Embase Ovid (1980 to 28 September 2016); and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 28 September 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials assessing the effects of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for at least 4 weeks on gingivitis in children and adults. Mechanical oral hygiene procedures were toothbrushing with/without use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment. We included trials where participants had gingivitis or periodontitis, where participants were healthy and where some or all participants had medical conditions or special care needs.\nData collection and analysis\nTwo review authors independently screened the search results extracted data and assessed the risk of bias of the included studies. We attempted to contact study authors for missing data or clarification where feasible. For continuous outcomes, we used means and standard deviations to obtain the mean difference (MD) and 95% confidence interval (CI). We combined MDs where studies used the same scale and standardised mean differences (SMDs) where studies used different scales. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs. Due to anticipated heterogeneity we used random-effects models for all meta-analyses.\nMain results\nWe included 51 studies that analysed a total of 5345 participants. One study was assessed as being at unclear risk of bias, with the remaining 50 being at high risk of bias, however, this did not affect the quality assessments for gingivitis and plaque as we believe that further research is very unlikely to change our confidence in the estimate of effect.\nGingivitis\nAfter 4 to 6 weeks of use, chlorhexidine mouthrinse reduced gingivitis (Gingival Index (GI) 0 to 3 scale) by 0.21 (95% CI 0.11 to 0.31) compared to placebo, control or no mouthrinse (10 trials, 805 participants with mild gingival inflammation (mean score 1 on the GI scale) analysed, high-quality evidence). A similar effect size was found for reducing gingivitis at 6 months. There were insufficient data to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 (moderate or severe levels of gingival inflammation).\nPlaque\nPlaque was measured by different indices and the SMD at 4 to 6 weeks was 1.45 (95% CI 1.00 to 1.90) standard deviations lower in the chlorhexidine group (12 trials, 950 participants analysed, high-quality evidence), indicating a large reduction in plaque. A similar large reduction was found for chlorhexidine mouthrinse use at 6 months.\nExtrinsic tooth staining\nThere was a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 4 to 6 weeks. The SMD was 1.07 (95% CI 0.80 to 1.34) standard deviations higher (eight trials, 415 participants analysed, moderate-quality evidence) in the chlorhexidine mouthrinse group. There was also a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 7 to 12 weeks and 6 months.\nCalculus\nResults for the effect of chlorhexidine mouthrinse on calculus formation were inconclusive.\nEffect of concentration and frequency of rinsing\nThere were insufficient data to determine whether there was a difference in effect for either chlorhexidine concentration or frequency of rinsing.\nOther adverse effects\nThe adverse effects most commonly reported in the included studies were taste disturbance/alteration (reported in 11 studies), effects on the oral mucosa including soreness, irritation, mild desquamation and mucosal ulceration/erosions (reported in 13 studies) and a general burning sensation or a burning tongue or both (reported in nine studies).\nAuthors' conclusions\nThere is high-quality evidence from studies that reported the Löe and Silness Gingival Index of a reduction in gingivitis in individuals with mild gingival inflammation on average (mean score of 1 on the 0 to 3 GI scale) that was not considered to be clinically relevant. There is high-quality evidence of a large reduction in dental plaque with chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for 4 to 6 weeks and 6 months. There is no evidence that one concentration of chlorhexidine rinse is more effective than another. There is insufficient evidence to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 indicating moderate or severe levels of gingival inflammation. Rinsing with chlorhexidine mouthrinse for 4 weeks or longer causes extrinsic tooth staining. In addition, other adverse effects such as calculus build up, transient taste disturbance and effects on the oral mucosa were reported in the included studies.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does the use of chlorhexidine mouthrinse (a broad spectrum antiseptic) in addition to other conventional tooth cleaning help to control and improve gingivitis (inflammation of the gums)? Does the frequency of rinsing or the concentration of the solution affect the result and are there any undesirable side effects?"
}
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query-laysum | 5292 | [
{
"role": "user",
"content": "Abstract: Background\nHeartburn is one of the most common gastrointestinal symptoms in pregnant women. It can occur in all trimesters of pregnancy. The symptoms of heartburn in pregnancy may be frequent, severe and distressing, but serious complications are rare. Many interventions have been used for the treatment of heartburn in pregnancy. These interventions include advice on diet, lifestyle modification and medications. However, there has been no evidence-based recommendation for the treatment of heartburn in pregnancy.\nObjectives\nTo assess the effects of interventions for relieving heartburn in pregnancy.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2015), ClinicalTrials.gov (2 March 2015), Asian & Oceanic Congress of Obstetrics & Gynaecology (AOCOG) conference proceedings (20-23 October 2013, Centara Grand & Bangkok Convention Centre, Bangkok, Thailand), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTS of interventions for heartburn in pregnancy compared with another intervention, or placebo, or no intervention. Cluster-RCTs would have been eligible for inclusion but none were identified. We excluded studies available as abstracts only and those using a cross-over design.\nInterventions could include advice on diet, lifestyle modification and medications (such as antacids, sucralfate, histamine 2-receptor antagonists, promotility drugs and proton pump inhibitors (PPIs)).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nWe included nine RCTs involving 725 women. However, five trials did not contribute data. Four trials involving 358 women contributed data. Trials were generally at mixed risk of bias.\nWe only identified data for three comparisons: pharmaceutical treatment versus placebo or no treatment; acupuncture versus no treatment and pharmacological intervention versus advice on dietary and lifestyle changes.\nPharmaceutical treatment compared with placebo or no treatment\nTwo trials evaluated any pharmaceutical treatment compared with placebo or no treatment. One trial examined a treatment rarely used nowadays (intramuscular prostigmine 0.5 mg versus placebo). One trial evaluated the effect of magnesium and aluminium hydroxide plus simethicone liquid and tablet compared with placebo. For the primary outcome of this review (relief of heartburn), women who received pharmaceutical treatment reported complete heartburn relief more often than women receiving no treatment or placebo (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.36 to 2.50 in two RCTs of 256 women, I2 = 0%, moderate-quality evidence). Data on partial relief of heartburn were heterogenous and showed no clear difference (average RR 1.35, 95% CI 0.38 to 4.76 in two RCTs of 256 women, very low-quality evidence). In terms of secondary outcomes, there was no clear difference in the rate of side effects between the pharmaceutical treatment group and the placebo/no treatment group (RR 0.63, 95% CI 0.21 to 1.89 in two RCTs of 256 women, very low-quality evidence).\nPharmacological intervention versus advice on dietary and lifestyle choices\nOne study compared 1 g of sucralfate with advice on dietary and lifestyle choices in treating heartburn. More women in the sucralfate group experienced complete relief of heartburn compared to women who received advice on diet and lifestyle choices (RR 2.41, 95% CI 1.42 to 4.07; participants = 65; studies = one). The only secondary outcome of interest addressed by this trial was side effects. The evidence was not clear on intervention side effects rate between the two groups (RR 1.74, 95% CI 0.07 to 41.21; participants = 66; studies = one). There was only one instance of side effects in the pharmacological group.\nAcupuncture compared with no treatment\nOne trial evaluated acupuncture compared with no treatment but did not report data relating to this review's primary outcome (relief of heartburn). In terms of secondary outcomes, there was no difference in the rate of side effects between women who had acupuncture and women who had no treatment (RR 2.43, 95% CI 0.11 to 55.89 in one RCT of 36 women). With regard to quality of life, women who had acupuncture reported improved ability to sleep (RR 2.80, 95% CI 1.14 to 6.86) and eat (RR 2.40, 95% CI 1.11 to 5.18 in one RCT of 36 women).\nThe following secondary outcomes were not reported upon in any of the trials included in the review: miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight.\nAuthors' conclusions\nThere are no large-scale RCTs to assess heartburn relief in pregnancy. This review of nine small studies (which involved data from only four small studies) indicates that there are limited data suggesting that heartburn in pregnancy could be completely relieved by pharmaceutical treatment. Three outcomes were assessed and assigned a quality rating using the GRADE methods. Evidence from two trials for the outcome of complete relief of heartburn was assessed as of moderate quality. Evidence for the outcomes of partial heartburn relief and side effects was graded to be of very low quality. Downgrading decisions were based in part on the small size of the trials and on heterogenous and imprecise results.\nThere are insufficient data to assess acupuncture versus no treatment and no data to assess other comparisons (miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight).\nFurther RCTs are needed to fully evaluate the effectiveness of interventions for heartburn in pregnancy. Future research should also address other medications such as histamine 2-receptor antagonists, promotility drugs, proton pump inhibitors, and a raft-forming alginate reflux suppressant in treatment of heartburn in pregnancy. More research is needed on acupuncture and other complimentary therapies as treatments for heartburn in pregnancy. Future research should also evaluate any adverse outcomes, maternal satisfaction with treatment and measure pregnant women's quality of life in relation to the intervention.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Heartburn is a sensation of burning in the upper part of the digestive tract including the throat. It is one of the most common gut symptoms in pregnant women and it can occur anytime during pregnancy. It is caused by pregnancy hormones affecting the muscle that keeps food in the stomach, and letting acid in the stomach come back up the throat. The symptoms may be frequent, severe and distressing, but serious complications are rare. Many interventions have been suggested. Lifestyle modifications are suggested for treating mild symptoms. Women are often advised to eat smaller meals, chew gum, not to eat late at night, to elevate the head of the bed and avoid foods and medications that cause heartburn. Abstinence from alcohol and tobacco are encouraged to reduce reflux symptoms and to avoid fetal exposure to these harmful substances. For more troubling reflux symptoms, medications are sometimes used. The common drugs used for the treatment of heartburn in pregnancy include antacids, drugs that stimulate the muscles of the gastrointestinal tract to prevent acids from staying in the stomach too long."
}
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query-laysum | 5293 | [
{
"role": "user",
"content": "Abstract: Background\nRoot canal therapy is a sequence of treatments involving root canal cleaning, shaping, decontamination, and obturation. It is conventionally performed through a hole drilled into the crown of the affected tooth, namely orthograde root canal therapy. When it fails, retrograde filling, which seals the root canal from the root apex, is a good alternative. Many materials are used for retrograde filling. Since none meets all the criteria an ideal material should possess, selecting the most efficacious material is of utmost importance. This is an update of a Cochrane Review first published in 2016.\nObjectives\nTo determine the effects of different materials used for retrograde filling in children and adults for whom retrograde filling is necessary in order to save the tooth.\nSearch methods\nAn Information Specialist searched five bibliographic databases up to 21 April 2021 and used additional search methods to identify published, unpublished, and ongoing studies. We also searched four databases in the Chinese language.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that compared different retrograde filling materials, with the reported success rate that was assessed by clinical or radiological methods for which the follow-up period was at least 12 months.\nData collection and analysis\nRecords were screened in duplicate by independent screeners. Two review authors extracted data independently and in duplicate. Original trial authors were contacted for any missing information. Two review authors independently assessed the risk of bias of the included studies. We followed Cochrane's statistical guidelines and assessed the certainty of the evidence using GRADE.\nMain results\nWe included eight studies, all at high risk of bias, involving 1399 participants with 1471 teeth, published between 1995 and 2019, and six comparisons of retrograde filling materials.\n- Mineral trioxide aggregate (MTA) versus intermediate restorative material (IRM): there may be little to no effect of MTA compared to IRM on success rate at one year, but the evidence is very uncertain (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.97 to 1.22; I2 = 0%; 2 studies; 222 teeth; very low-certainty evidence).\n- MTA versus super ethoxybenzoic acid (Super-EBA): there may be little to no effect of MTA compared to Super-EBA on success rate at one year, but the evidence is very uncertain (RR 1.03, 95% CI 0.96 to 1.10; 1 study; 192 teeth; very low-certainty evidence).\n- Super-EBA versus IRM: the evidence is very uncertain about the effect of Super-EBA compared with IRM on success rate at 1 year, with results indicating Super-EBA may reduce or have no effect on success rate (RR 0.90, 95% CI 0.80 to 1.01; 1 study; 194 teeth; very low-certainty evidence).\n- Dentine-bonded resin composite versus glass ionomer cement: compared to glass ionomer cement, dentine-bonded resin composite may increase the success rate of the treatment at 1 year, but the evidence is very uncertain (RR 2.39, 95% CI 1.60 to 3.59; 1 study; 122 teeth; very low-certainty evidence). Same result was obtained when considering the root as unit of analysis at one year (RR 1.59, 95% CI 1.20 to 2.09; 1 study; 127 roots; very low-certainty evidence).\n- Glass ionomer cement versus amalgam: the evidence is very uncertain about the effect of glass ionomer cement compared with amalgam on success rate at one year, with results indicating glass ionomer cement may reduce or have no effect on success rate (RR 0.98, 95% CI 0.86 to 1.12; 1 study; 105 teeth; very low-certainty evidence).\n- MTA versus root repair material (RRM): there may be little to no effect of MTA compared to RRM on success rate at one year, but the evidence is very uncertain (RR 1.00, 95% CI 0.94 to 1.07; I2 = 0%; 2 studies; 278 teeth; very low-certainty evidence).\nAdverse events were not assessed by any of the included studies.\nAuthors' conclusions\nBased on the present limited evidence, there is insufficient evidence to draw any conclusion as to the benefits of any one material over another for retrograde filling in root canal therapy. We conclude that more high-quality RCTs are required.\n\nGiven the provided abstract, please respond to the following query: \"What materials can be used for retrograde filling?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Many materials have been developed to seal the root tip, for example, mineral trioxide aggregate (MTA), intermediate restorative material (IRM), super ethoxybenzoic acid (Super-EBA), dentine-bonded resin composite, glass ionomer cement, amalgam, and root repair material (RRM). However, there is no agreement on which material is best."
}
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query-laysum | 5294 | [
{
"role": "user",
"content": "Abstract: Background\nUrinary tract infection (UTI) is common in children. Symptoms include fever, lethargy, anorexia, and vomiting. UTI is caused by Escherichia coli in over 80% of cases and treatment is a course of antibiotics. Due to acute illness caused by UTI and the risk of pyelonephritis-induced permanent kidney damage, many children are given long-term (several months to 2 years) antibiotics aimed at preventing recurrence. This is the third update of a review first published in 2001 and updated in 2006, and 2011.\nObjectives\nTo assess whether long-term antibiotic prophylaxis was more effective than placebo/no treatment in preventing recurrence of UTI in children, and if so which antibiotic in clinical use was the most effective. We also assessed the harms of long-term antibiotic treatment.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 30 July 2018 through contact with the Cochrane Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nRandomised comparisons of antibiotics with other antibiotics, placebo or no treatment to prevent recurrent UTI in children.\nData collection and analysis\nTwo authors independently assessed and extracted information for the initial and previous updates. A random-effects model was used to estimate risk ratio (RR) and risk difference (RD) for recurrent UTI with 95% confidence intervals (CI).\nMain results\nIn this update sixteen studies (2036 children randomised, 1977 analysed) were included. Seven studies (612 children) compared two or more types of antibiotics, six (1088 children) compared antibiotics with placebo or no treatment, one four-armed study compared circumcision with and without antibiotic treatment, one study compared dose of antibiotic, and one three-armed study compared two different antibiotics as well as no treatment. Of the sixteen included studies only one study was judged to be at low risk of bias for all domains, with the majority judged to be at unclear risk of bias due to very poorly reported methodology. The number of studies judged to be a low risk of bias was: selection bias (7); performance bias (4); detection bias (1); attrition bias (6); reporting bias (7); and other bias (2). The number of studies judged to be at high risk of bias was: selection bias (0); performance bias (5); detection bias (1); attrition bias (4); reporting bias (6); and other bias (1).\nCompared to placebo/no treatment, antibiotics lead to a modest decrease in the number of repeat symptomatic UTI in children; however the estimate from combining all studies was not certain and the confidence interval indicates low precision indicating that antibiotics may make little or no difference to risk of repeat infection (RR 0.75, 95% CI 0.28 to 1.98). When we combined only the data from studies with concealed treatment allocation, there was a similar reduction in risk of repeat symptomatic UTI in children taking antibiotics (RR 0.68) and we have greater certainty in this estimate because of the more robust study designs, the confidence interval is smaller and it does not include the point of no effect (95% CI 0.48 to 0.95). The estimated reduction in risk of repeat symptomatic UTI for children taking antibiotics was similar in children with vesicoureteric reflux (VUR) (RR 0.65, 95% CI 0.39 to 1.07) compared to those without VUR (RR 0.56, 95% CI 0.15 to 2.12) however there was considerable uncertainty due to imprecision from fewer events in the smaller group of children with VUR. There was no consistency in occurrence of adverse events, with one study having more events in the placebo group and a second study having more events in the antibiotics group. Three studies reported data for antibiotic resistance with the analysis estimating the risk of a UTI caused by a bacteria resistant to the prophylactic antibiotic being almost 2.5 times greater in children on antibiotics than for children on placebo or no treatment (RR 2.40, 95% CI 0.62 to 9.26). However the confidence interval is wide, showing imprecision and there may be little or no difference between the two groups.\nEight studies involving 659 children compared one antibiotic with another but few studies compared the same combination for the same outcome so little data could be pooled. Two studies reported microbial resistance data and analysis showed that treatment with nitrofurantoin may lead to a lower risk of a UTI caused by a bacteria resistant to the treatment drug compared to children given trimethoprim-sulphamethoxazole as their prophylactic treatment (RR 0.54, 95% CI 0.31 to 0.92).\nAuthors' conclusions\nLong-term antibiotics may reduce the risk of repeat symptomatic UTI in children who have had one or more previous UTIs but the benefit may be small and must be considered together with the increased risk of microbial resistance.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Bladder and kidney infections (urinary tract infection - UTI) are common in children, especially girls. They cause an uncomfortable illness that can include vomiting, fever and tiredness. In some children kidney damage may occur, as can repeat illnesses. With repeated infections the risk of kidney damage increases. Some doctors prescribe long-term antibiotics to try to prevent infections recurring, but this may cause the child to be unwell in other ways, e.g. vomiting"
}
]
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query-laysum | 5295 | [
{
"role": "user",
"content": "Abstract: Background\nVaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). This is an update of a Chochrane systematic review; the original version was first published in October 2006.\nObjectives\nThe objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women.\nSearch methods\nWe searched the following databases and trials registers to April 2016: Cochrane Gynaecology and Fertility Group Register of trials, The Cochrane Central Register of Controlled Trials (CENTRAL; 2016 issue 4), MEDLINE, Embase, PsycINFO, DARE, the Web of Knowledge, OpenGrey, LILACS, PubMed and reference lists of articles. We also contacted experts and researchers in the field.\nSelection criteria\nThe inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for at least 12 weeks for the treatment of symptoms resulting from vaginal atrophy or vaginitis.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias and extracted the data. The primary review outcomes were improvement in symptoms (participant-assessed), and the adverse event endometrial thickness. Secondary outcomes were improvement in symptoms (clinician-assessed), other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) and adherence to treatment. We combined data to calculate pooled risk ratios (RRs) (dichotomous outcomes) and mean differences (MDs) (continuous outcomes) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I2 statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nWe included 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. The evidence was low to moderate quality; limitations were poor reporting of study methods and serious imprecision (effect estimates with wide confidence intervals)\n1. Oestrogen ring versus other regimens\nOther regimens included oestrogen cream, oestrogen tablets and placebo. There was no evidence of a difference in improvement in symptoms (participant assessment) either between oestrogen ring and oestrogen cream (odds ratio (OR) 1.33, 95% CI 0.80 to 2.19, two RCTs, n = 341, I2 = 0%, low-quality evidence) or between oestrogen ring and oestrogen tablets (OR 0.78, 95% CI 0.53 to 1.15, three RCTs, n = 567, I2 = 0%, low-quality evidence). However, a higher proportion of women reported improvement in symptoms following treatment with oestrogen ring compared with placebo (OR 12.67, 95% CI 3.23 to 49.66, one RCT, n = 67). With respect to endometrial thickness, a higher proportion of women who received oestrogen cream showed evidence of increase in endometrial thickness compared to those who were treated with oestrogen ring (OR 0.36, 95% CI 0.14 to 0.94, two RCTs, n = 273; I2 = 0%, low-quality evidence). This may have been due to the higher doses of cream used.\n2. Oestrogen tablets versus other regimens\nOther regimens in this comparison included oestrogen cream, and placebo. There was no evidence of a difference in the proportions of women who reported improvement in symptoms between oestrogen tablets and oestrogen cream (OR 1.06, 95% CI 0.55 to 2.01, two RCTs, n = 208, I2 = 0% low-quality evidence). A higher proportion of women who were treated with oestrogen tablets reported improvement in symptoms compared to those who received placebo using a fixed-effect model (OR 12.47, 95% CI 9.81 to 15.84, two RCTs, n = 1638, I2 = 83%, low-quality evidence); however, using a random-effect model did not demonstrate any evidence of a difference in the proportions of women who reported improvement between the two treatment groups (OR 5.80, 95% CI 0.88 to 38.29). There was no evidence of a difference in the proportions of women with increase in endometrial thickness between oestrogen tablets and oestrogen cream (OR 0.31, 95% CI 0.06 to 1.60, two RCTs, n = 151, I2 = 0%, low-quality evidence).\n3. Oestrogen cream versus other regimens\nOther regimens identified in this comparison included isoflavone gel and placebo. There was no evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and isoflavone gel (OR 2.08, 95% CI 0.08 to 53.76, one RCT, n = 50, low-quality evidence). However, there was evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and placebo with more women who received oestrogen cream reporting improvement in symptoms compared to those who were treated with placebo (OR 4.10, 95% CI 1.88 to 8.93, two RCTs, n = 198, I2 = 50%, low-quality evidence). None of the included studies in this comparison reported data on endometrial thickness.\nAuthors' conclusions\nThere was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. However, there was low-quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo. There was low-quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring; this may have been due to the higher doses of cream used. However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 30 randomised controlled trials comparing intravaginal oestrogenic preparations with one another or with placebo in a total of 6235 postmenopausal women undergoing treatment for the symptoms of vaginal atrophy. The evidence is current to April 2016."
}
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query-laysum | 5296 | [
{
"role": "user",
"content": "Abstract: Background\nHuman milk alone may provide inadequate amounts of protein to meet the growth requirements of preterm infants because of restrictions in the amount of fluid they can tolerate. It has become common practice to feed preterm infants with breast milk fortified with protein and other nutrients but there is debate about the optimal concentration of protein in commercially available fortifiers.\nObjectives\nTo compare the effects of different protein concentrations in human milk fortifier, fed to preterm infants, on growth and neurodevelopment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search CENTRAL (2019, Issue 8), Ovid MEDLINE and CINAHL on 15 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included all published and unpublished randomised, quasi-randomised and cluster-randomised trials comparing two different concentrations of protein in human milk fortifier.\nWe included preterm infants (less than 37 weeks' gestational age). Participants may have been exclusively fed human milk or have been supplemented with formula.\nThe concentration of protein was classified as low (< 1g protein/100 mL expressed breast milk (EBM)), moderate (≥ 1g to < 1.4g protein/100 mL EBM) or high (≥ 1.4g protein/100 mL EBM). We excluded trials that compared two protein concentrations that fell within the same category.\nData collection and analysis\nWe undertook data collection and analyses using the standard methods of Cochrane Neonatal. Two review authors independently evaluated trials. Primary outcomes included growth, neurodevelopmental outcome and mortality. Data were synthesised using risk ratios (RR), risk differences and mean differences (MD), with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe identified nine trials involving 861 infants. There is one trial awaiting classification, and nine ongoing trials. The trials were mostly conducted in infants born < 32 weeks' gestational age or < 1500 g birthweight, or both. All used a fortifier derived from bovine milk. Two trials fed infants exclusively with mother's own milk, three trials gave supplementary feeds with donor human milk and four trials supplemented with preterm infant formula. Overall, trials were small but generally at low or unclear risk of bias.\nHigh versus moderate protein concentration of human milk fortifier\nThere was moderate certainty evidence that a high protein concentration likely increased in-hospital weight gain compared to moderate concentration of human milk fortifier (MD 0.66 g/kg/day, 95% CI 0.51 to 0.82; trials = 6, participants = 606). The evidence was very uncertain about the effect of high versus moderate protein concentration on length gain (MD 0.01 cm/week, 95% CI –0.01 to 0.03; trials = 5, participants = 547; very low certainty evidence) and head circumference gain (MD 0.00 cm/week, 95% CI –0.01 to 0.02; trials = 5, participants = 549; very low certainty evidence).\nOnly one trial reported neonatal mortality, with no deaths in either group (participants = 45).\nModerate versus low protein concentration of human milk fortifier\nA moderate versus low protein concentration fortifier may increase weight gain (MD 2.08 g/kg/day, 95% CI 0.38 to 3.77; trials = 2, participants = 176; very low certainty evidence) with little to no effect on head circumference gain (MD 0.13 cm/week, 95% CI 0.00 to 0.26; I² = 85%; trials = 3, participants = 217; very low certainty evidence), but the evidence is very uncertain. There was low certainty evidence that a moderate protein concentration may increase length gain (MD 0.09 cm/week, 95% CI 0.05 to 0.14; trials = 3, participants = 217).\nOnly one trial reported mortality and found no difference between groups (RR 0.48, 95% CI 0.05 to 5.17; participants = 112).\nNo trials reported long term growth or neurodevelopmental outcomes including cerebral palsy and developmental delay.\nAuthors' conclusions\nFeeding preterm infants with a human milk fortifier containing high amounts of protein (≥ 1.4g/100 mL EBM) compared with a fortifier containing moderate protein concentration (≥ 1 g to < 1.4 g/100 mL EBM) results in small increases in weight gain during the neonatal admission. There may also be small increases in weight and length gain when infants are fed a fortifier containing moderate versus low protein concentration (< 1 g protein/100 mL EBM). The certainty of this evidence is very low to moderate; therefore, results may change when the findings of ongoing studies are available. There is insufficient evidence to assess the impact of protein concentration on adverse effects or long term outcomes such as neurodevelopment. Further trials are needed to determine whether modest increases in weight gain observed with higher protein concentration fortifiers are associated with benefits or harms to long term growth and neurodevelopment.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Although there was some evidence that use of human milk fortifiers with a high or moderate protein concentration are associated with small increases in weight gain during hospital stay, there are no data about the impact on growth after the hospital admission or on developmental outcomes. Further well designed trials are needed to determine whether the amount of protein in human milk fortifiers is associated with benefits or harms in the longer term."
}
]
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query-laysum | 5297 | [
{
"role": "user",
"content": "Abstract: Background\nYoga is an ancient spiritual practice that originated in India and is currently accepted in the Western world as a form of relaxation and exercise. It has been of interest for people with schizophrenia to determine its efficacy as an adjunct to standard-care treatment.\nObjectives\nTo examine the effects of yoga versus standard care for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (November 2012 and January 29, 2015), which is based on regular searches of MEDLINE, PubMed, EMBASE, CINAHL, BIOSIS, AMED, PsycINFO, and registries of clinical trials. We searched the references of all included studies. There were no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nAll randomised controlled trials (RCTs) including people with schizophrenia comparing yoga to standard-care control.\nData collection and analysis\nThe review team independently selected studies, quality rated these, and extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed mixed-effect and fixed-effect models for analyses. We examined data for heterogeneity (I2 technique), assessed risk of bias for included studies, and created 'Summary of findings' tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nWe included eight studies in the review. All outcomes were short term (less than six months). There were clear differences in a number of outcomes in favour of the yoga group, although these were based on one study each, with the exception of leaving the study early. These included mental state (improvement in Positive and Negative Syndrome Scale, 1 RCT, n = 83, RR 0.70 CI 0.55 to 0.88, medium-quality evidence), social functioning (improvement in Social Occupational Functioning Scale, 1 RCT, n = 83, RR 0.88 CI 0.77 to 1, medium-quality evidence), quality of life (average change 36-Item Short Form Survey (SF-36) quality-of-life subscale, 1 RCT, n = 60, MD 15.50, 95% CI 4.27 to 26.73, low-quality evidence), and leaving the study early (8 RCTs, n = 457, RR 0.91 CI 0.6 to 1.37, medium-quality evidence). For the outcome of physical health, there was not a clear difference between groups (average change SF-36 physical-health subscale, 1 RCT, n = 60, MD 6.60, 95% CI -2.44 to 15.64, low-quality evidence). Only one study reported adverse effects, finding no incidence of adverse events in either treatment group. This review was subject to a considerable number of missing outcomes, which included global state, change in cognition, costs of care, effect on standard care, service intervention, disability, and activities of daily living.\nAuthors' conclusions\nEven though we found some positive evidence in favour of yoga over standard-care control, this should be interpreted cautiously in view of outcomes largely based each on one study with limited sample sizes and short-term follow-up. Overall, many outcomes were not reported and evidence presented in this review is of low to moderate quality - -too weak to indicate that yoga is superior to standard-care control for the management of schizophrenia.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Yoga comes from ancient India and involves physical postures and breathing exercises to promote balance between mind and body. Yoga has now been widely adopted as a method of relaxation and exercise, improving strength, flexibility, co-ordination, endurance, and breathing control and concentration. Yoga has also been shown to reduce stress and promote health and feelings of well-being. Yoga has been used as a complementary therapy for many health conditions, including improving blood pressure control as well as mental health conditions such as depression and anxiety disorders.\nSome research suggests that yoga could also be of benefit as an add-on treatment to reduce the complex symptoms of schizophrenia (such as hearing voices, seeing things, lack of interest in people and activities, tiredness, loss of emotions and withdrawal) and improve the quality of life of people with schizophrenia. Yoga and its use specifically for people with schizophrenia is under-researched."
}
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query-laysum | 5298 | [
{
"role": "user",
"content": "Abstract: Background\nMany employers and other stakeholders believe that health examinations of job applicants prevent occupational diseases and sickness absence. This is an update of the original Cochrane review (Mahmud 2010).\nObjectives\nTo evaluate the effectiveness of pre-employment examinations of job applicants in preventing occupational injury, disease and sick leave compared to no intervention or alternative interventions.\nSearch methods\nWe searched CENTRAL (the Cochrane Library), MEDLINE, EMBASE, CINAHL, PsycINFO and PEDro (up to 31 March 2015). We did not impose any restrictions on date, language or publication type.\nSelection criteria\nWe included randomised controlled trials (RCTs), controlled before-after (CBA) studies, and interrupted time-series (ITS) studies of health examinations to prevent occupational diseases and injuries in job applicants in comparison to no intervention or alternative interventions.\nData collection and analysis\nAll five review authors independently selected studies from the updated search for inclusion. We retrieved two new studies with the updated search from 1 April 2008 to 31 March 2015, resulting in a total of eleven studies.\nMain results\nWe included two RCTs, seven CBA studies and two ITS studies. Nine studies with 7820 participants evaluated the screening process of pre-employment examinations as a whole, and two studies with 2164 participants evaluated the measures to mitigate the risks found following the screening process. The studies were too heterogeneous for statistical pooling of results. We rated the quality of the evidence for all outcomes as very low quality. The two new CBA studies both used historical controls and both had a high risk of bias.\nOf those studies that evaluated the screening process, there is very low quality evidence based on one RCT that a general examination for light duty work may not reduce the risk for sick leave (mean difference (MD) -0.09, 95% confidence interval (CI) -0.47 to 0.29). For army recruits, there is very low quality evidence based on one CBA study that there is a positive effect on fitness for duty after 12 months follow-up (odds ratio (OR) 0.40, 95% CI 0.19 to 0.85).\nWe found inconsistent evidence of an effect of job-focused pre-employment examinations on the risk of musculoskeletal injuries in comparison with general or no pre-employment examination based on one RCT with high risk of bias, and four CBA studies. There is very low quality evidence based on one ITS study that incorporation of a bronchial challenge test may decrease occupational asthma (trend change -2.6, 95% CI -3.6 to -1.5) compared to a general pre-employment examination with lung function tests.\nPre-employment examinations may also result in a rejection of the applicant for the new job. In six studies, the rates of rejecting job applicants increased because of the studied examinations , on average, from 2% to 35%, but not in one study.\nThere is very low quality evidence based on two CBA studies that risk mitigation among applicants considered not fit for work at the pre-employment examination may result in a similar risk of work-related musculoskeletal injury during follow-up compared to workers considered fit for work at the health examination.\nAuthors' conclusions\nThere is very low quality evidence that a general examination for light duty work may not reduce the risk for sick leave, but may have a positive effect on fitness for duty for army recruits after 12 months follow-up.\nThere is inconsistent evidence of an effect of job-focused pre-employment examinations on the risk of musculoskeletal injuries in comparison with general or no pre-employment examination. There is very low quality evidence that incorporation of a bronchial challenge test may decrease occupational asthma compared to a general pre-employment examination with lung function tests. Pre-employment examinations may result in an increase of rejecting job applicants in six out of seven studies.\nRisk mitigation based on the result of pre-employment examinations may be effective in reducing an increased risk for occupational injuries based on very low quality evidence. This evidence supports the current policy to restrict pre-employment examinations to only job-specific examinations. Better quality evaluation studies on pre-employment examinations are necessary, including the evaluation of the benefits of risk mitigation, given the effect on health and on the financial situation for those employees who do not pass the pre-employment examination.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Health examinations that focus on health risks of particular jobs may be effective. Adequately dealing with potential health risks by changing work tasks or physical fitness training may also be effective. We need more and better quality evaluation studies. Not allowing people to work in certain jobs may have effects on their health. It also costs them money. Future research should assess both."
}
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query-laysum | 5299 | [
{
"role": "user",
"content": "Abstract: Background\nThe optimal treatment for end-stage kidney disease is kidney transplantation. During the operation, a catheter is introduced into the bladder and remains in place postoperatively to allow the bladder to drain. This decreases tension from the cysto-ureteric anastomosis and promotes healing. Unfortunately, urinary catheters can pose an infection risk to patients as they allow bacteria into the bladder, potentially resulting in a urinary tract infection (UTI). The longer the catheter remains in place, the greater the risk of developing a UTI. There is no consensus approach to the time a catheter should remain in place post-transplant. Furthermore, the different timings of catheter removal are thought to be associated with different incidences of UTI and postoperative complications, such as anastomotic breakdown.\nObjectives\nThis review aimed to compare patients who had their catheter removed < 5 days post-transplant surgery to those patients who had their catheter removed ≥ 5 days following their kidney transplant. Primary outcome measures between the two groups included: the incidence of symptomatic UTIs, the incidence of asymptomatic bacteriuria and the incidence of major urological complications requiring intervention and treatment.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 13 April 2023 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs comparing timing of catheter removal post-transplantation were eligible for inclusion. All donor types were included, and all recipients were included regardless of age, demographics or type of urinary catheter used.\nData collection and analysis\nResults from the literature search were screened by two authors to identify if they met our inclusion criteria. We designated removal of a urinary catheter before five days (120 hours) as an 'early removal' and anything later than this as a 'late removal.' The studies were assessed for quality using the risk of bias tool. The primary outcome of interest was the incidence of asymptomatic bacteriuria. Statistical analyses were performed using the random effects model, and results were expressed as relative risk (RR) with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nTwo studies (197 patients) were included in our analysis. One study comprised a full-text article, and the other was a conference abstract with very limited information. The risk of bias in the included studies was generally either high or unclear.\nIt is uncertain whether early versus late removal of the urinary catheter made any difference to the incidence of asymptomatic bacteriuria (RR 0.89, 95% Cl 0.17 to 4.57; participants = 197; I2 = 88%; very low certainty evidence). Data on other outcomes, such as the incidence of UTI and the incidence of major urological complications, were lacking. Furthermore, the follow-up of patients across the studies was short, with no patients being followed beyond one month.\nAuthors' conclusions\nA high-quality, well-designed RCT is required to compare the effectiveness of early catheter removal versus late catheter removal in patients following a kidney transplant. At the present time, there is insufficient evidence to suggest any difference between early and late catheter removal post-transplant, and the studies investigating this were generally of poor quality.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The ureter is a pipe that drains urine from the kidney into the bladder, where it is stored until patients go to the bathroom to pass urine. During a kidney transplant operation, the new kidney is placed inside the patient, and the new ureter is attached to the patient's bladder. During this procedure, a catheter is inserted through the urethra into the bladder and left in place following the operation. A catheter is a narrow flexible tube that allows urine to drain from the bladder. The catheter continuously drains urine and prevents the bladder from stretching. It is thought that by keeping the bladder empty, the connection between the new ureter and the bladder is able to heal better. However, catheters can introduce bacteria into the bladder and cause urine infections. The longer the catheter stays in the bladder, the greater the risk of getting an infection. Urine infections can be very troublesome for transplant patients, as they need to take medicines that suppress their immune system. These immunosuppressive medications mean patients find it very difficult to fight off infections. Currently, no one knows when the best time is for the removal of the catheter. We want to find this out so that we can minimise the risk of urine infections because of catheters whilst still giving the connection between the bladder and the new ureter the best possible chance of healing."
}
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query-laysum | 5300 | [
{
"role": "user",
"content": "Abstract: Background\nThe use of ultrasound guidance for regional anaesthesia has become popular over the past two decades. However, it is not recognized by all experts as an essential tool, perhaps because it is unclear whether ultrasound reduces the risk of severe neurological complications, and the cost of an ultrasound machine (USD 22,000) is substantially higher than the cost of other tools. This review was published in 2016 and updated in 2019.\nObjectives\nTo determine whether ultrasound guidance offers any clinical advantage when neuraxial and peripheral nerve blocks are performed in children in terms of decreasing failure rate or the rate of complications.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trial registers up to March 2018 together with reference checking to identify additional studies and contacted study authors to obtain additional trial information.\nSelection criteria\nWe included all parallel randomized controlled trials that evaluated the effects of ultrasound guidance used when a regional blockade technique was performed in children. We included studies performed in children (≤ 18 years of age) undergoing any type of surgical procedure (open or laparoscopic), for which a neuraxial (spinal, epidural, caudal, or combined spinal and epidural) or peripheral nerve block (any peripheral nerve block including fascial (fascia iliaca, transversus abdominis plane, rectus sheath blocks) or perivascular blocks), for surgical anaesthesia (alone or in combination with general anaesthesia) or for postoperative analgesia, was performed with ultrasound guidance. We excluded studies in which regional blockade was used to treat chronic pain.\nWe included studies in which ultrasound guidance was used to perform the technique in real time (in-plane or out-of-plane), as pre-scanning before the procedure or to evaluate the spread of the local anaesthetic so the position of the needle could be adjusted or the block complemented. For control groups, any other technique used to perform the block including landmarks, loss of resistance (air or fluid), click, paraesthesia, nerve stimulator, transarterial, or infiltration was accepted.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were failed blocks, pain scores at one hour after surgery, and block duration. Secondary outcomes included time to perform the block, number of needle passes, and minor and major complications. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included 33 trials with a total of 2293 participants from 0.9 to 12 (mean or median) years of age. Most trials were at low risk of selection, detection, attrition, and reporting bias, however the lack of blinding of participants and personnel caring for participants resulted in 25 trials being judged as at high or unclear risk of bias. We identified five ongoing trials.\nUltrasound guidance probably reduces the risk of failed block (risk difference (RD) −0.16, 95% confidence interval (CI) −0.25 to −0.07; 22 trials; 1789 participants; moderate-quality evidence). When ultrasound guidance was used, there was a small to moderate reduction in pain one hour after surgery, equivalent to a reduction of 1.3 points on the revised Bieri FACES pain scale (scale; 0 = no pain, 10 = maximal pain) (standardized mean difference (SMD) −0.41, 95% CI −0.74 to −0.07 (medium effect size); 15 trials; 982 participants; moderate-quality evidence). Ultrasound guidance increases block duration by the equivalent of 42 minutes (SMD 1.24, 95% CI 0.72 to 1.75; 10 trials; 460 participants; high-quality evidence).\nThere is probably little or no difference in the time taken to perform the block (SMD −0.46, 95% CI −1.06 to 0.13; 9 trials; 680 participants; moderate-quality evidence). It is uncertain whether the number of needle passes required is reduced with the use of ultrasound guidance (SMD −0.63, 95% CI −1.08 to −0.18; 3 trials; 256 participants; very low-quality evidence).\nThere were no occurrences of major complications in either the intervention or control arms of the trials (cardiac arrest from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence); lasting neurological injury (19 trials; 1250 participants; low-quality evidence)).\nThere may be little of no difference in the risk of bloody puncture (RD −0.02, 95% CI −0.05 to 0.00; 13 trials; 896 participants; low-quality evidence) or transient neurological injury (RD −0.00, 95% CI −0.01 to 0.01; 18 trials; 1230 participants; low-quality evidence). There were no occurrences of seizure from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence) or block infections without neurological injury (18 trials; 1238 participants; low-quality evidence).\nAuthors' conclusions\nUltrasound guidance for regional blockade in children probably decreases the risk of failed block. It increases the duration of the block and probably decreases pain scores at one hour after surgery. There may be little or no difference in the risks of some minor complications. The five ongoing studies may alter the conclusions of the review once published and assessed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 33 well-designed studies with a total of 2293 children in which ultrasound guidance was compared with another method of nerve localization (traditional landmarks techniques or nerve stimulator) for regional blockade in children."
}
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query-laysum | 5301 | [
{
"role": "user",
"content": "Abstract: Background\nComorbid depression and substance use disorders are common and have poorer outcomes than either disorder alone. While effective psychological treatments for depression or substance use disorders are available, relatively few randomised controlled trials (RCTs) have examined the efficacy of these treatments in people with these comorbid disorders.\nObjectives\nTo assess the efficacy of psychological interventions delivered alone or in combination with pharmacotherapy for people diagnosed with comorbid depression and substance use disorders.\nSearch methods\nWe searched the following databases up to February 2019: Cochrane Central Register of Controlled Trials, PubMed, Embase, CINAHL, Google Scholar and clinical trials registers. All systematic reviews identified, were handsearched for relevant articles.\nSelection criteria\nThe review includes data from RCTs of psychological treatments for people diagnosed with comorbid depression and substance use disorders, using structured clinical interviews. Studies were included if some of the sample were experiencing another mental health disorder (e.g. anxiety); however, studies which required a third disorder as part of their inclusion criteria were not included. Studies were included if psychological interventions (with or without pharmacotherapy) were compared with no treatment, delayed treatment, treatment as usual or other psychological treatments.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nSeven RCTs of psychological treatments with a total of 608 participants met inclusion criteria. All studies were published in the USA and predominately consisted of Caucasian samples. All studies compared different types of psychological treatments. Two studies compared Integrated Cognitive Behavioural Therapy (ICBT) with Twelve Step Facilitation (TSF), another two studies compared Interpersonal Psychotherapy for Depression (IPT-D) with other treatment (Brief Supportive Therapy (BST) or Psychoeducation). The other three studies compared different types or combinations of psychological treatments. No studies compared psychological interventions with no treatment or treatment as usual control conditions. The studies included a diverse range of participants (e.g. veterans, prisoners, community adults and adolescents).\nAll studies were at high risk of performance bias, other main sources were selection, outcome detection and attrition bias. Due to heterogeneity between studies only two meta-analyses were conducted. The first meta-analysis focused on two studies (296 participants) comparing ICBT to TSF. Very low-quality evidence revealed that while the TSF group had lower depression scores than the ICBT group at post-treatment (mean difference (MD) 4.05, 95% confidence interval (CI) 1.43 to 6.66; 212 participants), there was no difference between groups in depression symptoms (MD 1.53, 95% CI -1.73 to 4.79; 181 participants) at six- to 12-month follow-up. At post-treatment there was no difference between groups in proportion of days abstinent (MD -2.84, 95% CI -8.04 to 2.35; 220 participants), however, the ICBT group had a greater proportion of days abstinent than the TSF group at the six- to 12-month follow-up (MD 10.76, 95% CI 3.10 to 18.42; 189 participants). There were no differences between the groups in treatment attendance (MD -1.27, 95% CI -6.10 to 3.56; 270 participants) or treatment retention (RR 0.95, 95% CI 0.72 to 1.25; 296 participants).\nThe second meta-analysis was conducted with two studies (64 participants) comparing IPT-D with other treatment (Brief Supportive Psychotherapy/Psychoeducation). Very low-quality evidence indicated IPT-D resulted in significantly lower depressive symptoms at post-treatment (MD -0.54, 95% CI -1.04 to -0.04; 64 participants), but this effect was not maintained at three-month follow-up (MD 3.80, 95% CI -3.83 to 11.43) in the one study reporting follow-up outcomes (38 participants; IPT-D versus Psychoeducation). Substance use was examined separately in each study, due to heterogeneity in outcomes. Both studies found very low-quality evidence of no significant differences in substance use outcomes at post-treatment (percentage of days abstinent, IPD versus Brief Supportive Psychotherapy; MD -2.70, 95% CI -28.74 to 23.34; 26 participants) or at three-month follow-up (relative risk of relapse, IPT-D versus Psychoeducation; RR 0.67, 95% CI 0.30 to 1.50; 38 participants). There was also very low-quality evidence for no significant differences between groups in treatment retention (RR 1.00, 95% CI 0.81 to 1.23; 64 participants). No adverse events were reported in any study.\nAuthors' conclusions\nThe conclusions of this review are limited due to the low number and very poor quality of included studies. No conclusions can be made about the efficacy of psychological interventions (delivered alone or in combination with pharmacotherapy) for the treatment of comorbid depression and substance use disorders, as they are yet to be compared with no treatment or treatment as usual in this population. In terms of differences between psychotherapies, although some significant effects were found, the effects were too inconsistent and small, and the evidence of too poor quality, to be of relevance to practice.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies and found seven randomised controlled trials involving 608 people with comorbid depression and substance use disorders published between 2003 and 2014. All seven studies were published in the USA and predominately consisted of individuals from Caucasian backgrounds. No conclusions about the effectiveness of psychological interventions delivered with or without pharmacotherapy could be made, as no studies comparing these interventions with no treatment, delayed treatment or treatment as usual were found. All seven studies compared different types or combinations of psychological treatments. Few consistent differences in depression or substance use treatment outcomes were found. No conclusions about which type of psychological intervention was most effective could be made, due to the low number of studies found and very low quality of the evidence . None of the studies reported any harms related to receiving psychological treatment for depression and substance use disorders. All studies were funded by university and government research grants in the USA."
}
]
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query-laysum | 5302 | [
{
"role": "user",
"content": "Abstract: Background\nFeeding intolerance is a common clinical problem among preterm infants. It may be an early sign of necrotising enterocolitis, sepsis or other serious gastrointestinal conditions, or it may result from gut immaturity with delayed passage of meconium. Glycerin laxatives stimulate passage of meconium by acting as an osmotic dehydrating agent and increasing osmotic pressure in the gut; they stimulate rectal contraction, potentially reducing the incidence of feeding intolerance.\nObjectives\nTo assess the effectiveness and safety of glycerin laxatives (enemas/suppositories) for prevention or treatment of feeding intolerance in very low birth weight (VLBW) infants.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 4), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We restricted our search to all randomised controlled trials and applied no language restrictions. We searched the references of identified studies and reviews on this topic and handsearched for additional articles. We searched the database maintained by the US National Institutes of Health (www.clinicaltrials.gov) and European trial registries to identify ongoing trials.\nSelection criteria\nWe considered only randomised or quasi-randomised controlled trials that enrolled preterm infants < 32 weeks' gestational age (GA) and/or < 1500 g birth weight. We included trials if they administered glycerin laxatives and measured at least one prespecified clinical outcome.\nData collection and analysis\nWe used standard methods of The Cochrane Collaboration and its Neonatal Group to assess methodological quality of trials, to collect data and to perform analyses.\nMain results\nWe identified three trials that evaluated use of prophylactic glycerin laxatives in preterm infants. We identified no trials that evaluated therapeutic use of glycerin laxatives for feeding intolerance. Our review showed that prophylactic administration of glycerin laxatives did not reduce the time required to achieve full enteral feeds and did not influence secondary outcomes, including duration of hospital stay, mortality and weight at discharge. Prophylactic administration of glycerin laxatives resulted in failure of fewer infants to pass stool over the first 48 hours. Included trials reported no adverse events.\nAuthors' conclusions\nOur review of available evidence for glycerin laxatives does not support the routine use of prophylactic glycerin laxatives in clinical practice. Additional studies are needed to confirm or refute the effectiveness and safety of glycerin laxatives for prevention or treatment of feeding intolerance in VLBW infants.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our review identified three studies that addressed the use of glycerin suppositories to prevent feeding intolerance in preterm infants."
}
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query-laysum | 5303 | [
{
"role": "user",
"content": "Abstract: Background\nDietary advice is the main strategy for managing gestational diabetes mellitus (GDM). It remains unclear what type of advice is best.\nObjectives\nTo assess the effects of different types of dietary advice for women with GDM for improving health outcomes for women and babies.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (8 March 2016), PSANZ's Trials Registry (22 March 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials comparing the effects of different types of dietary advice for women with GDM.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, and extracted data. Evidence quality for two comparisons was assessed using GRADE, for primary outcomes for the mother: hypertensive disorders of pregnancy; caesarean section; type 2 diabetes mellitus; and child: large-for-gestational age; perinatal mortality; neonatal mortality or morbidity composite; neurosensory disability; secondary outcomes for the mother: induction of labour; perineal trauma; postnatal depression; postnatal weight retention or return to pre-pregnancy weight; and child: hypoglycaemia; childhood/adulthood adiposity; childhood/adulthood type 2 diabetes mellitus.\nMain results\nIn this update, we included 19 trials randomising 1398 women with GDM, at an overall unclear to moderate risk of bias (10 comparisons). For outcomes assessed using GRADE, downgrading was based on study limitations, imprecision and inconsistency. Where no findings are reported below for primary outcomes or pre-specified GRADE outcomes, no data were provided by included trials.\nPrimary outcomes\nLow-moderate glycaemic index (GI) versus moderate-high GI diet (four trials): no clear differences observed for: large-for-gestational age (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.22 to 2.34; two trials, 89 infants; low-quality evidence); severe hypertension or pre-eclampsia (RR 1.02, 95% CI 0.07 to 15.86; one trial, 95 women; very low-quality evidence); eclampsia (RR 0.34, 95% CI 0.01 to 8.14; one trial, 83 women; very low-quality evidence) or caesarean section (RR 0.66, 95% CI 0.29 to 1.47; one trial, 63 women; low-quality evidence).\nEnergy-restricted versus no energy-restricted diet (three trials): no clear differences seen for: large-for-gestational age (RR 1.17, 95% CI 0.65 to 2.12; one trial, 123 infants; low-quality evidence); perinatal mortality (no events; two trials, 423 infants; low-quality evidence); pre-eclampsia (RR 1.00, 95% CI 0.51 to 1.97; one trial, 117 women; low-quality evidence); or caesarean section (RR 1.12, 95% CI 0.80 to 1.56; two trials, 420 women; low-quality evidence).\nDASH (Dietary Approaches to Stop Hypertension) diet versus control diet (three trials): no clear differences observed for: pre-eclampsia (RR 1.00, 95% CI 0.31 to 3.26; three trials, 136 women); however there were fewer caesarean sections in the DASH diet group (RR 0.53, 95% CI 0.37 to 0.76; two trials, 86 women).\nLow-carbohydrate versus high-carbohydrate diet (two trials): no clear differences seen for: large-for-gestational age (RR 0.51, 95% CI 0.13 to 1.95; one trial, 149 infants); perinatal mortality (RR 3.00, 95% CI 0.12 to 72.49; one trial, 150 infants); maternal hypertension (RR 0.40, 95% CI 0.13 to 1.22; one trial, 150 women); or caesarean section (RR 1.29, 95% CI 0.84 to 1.99; two trials, 179 women).\nHigh unsaturated fat versus low unsaturated fat diet (two trials): no clear differences observed for: large-for-gestational age (RR 0.54, 95% CI 0.21 to 1.37; one trial, 27 infants); pre-eclampsia (no cases; one trial, 27 women); hypertension in pregnancy (RR 0.54, 95% CI 0.06 to 5.26; one trial, 27 women); caesarean section (RR 1.08, 95% CI 0.07 to 15.50; one trial, 27 women); diabetes at one to two weeks (RR 2.00, 95% CI 0.45 to 8.94; one trial, 24 women) or four to 13 months postpartum (RR 1.00, 95% CI 0.10 to 9.61; one trial, six women).\nLow-GI versus high-fibre moderate-GI diet (one trial): no clear differences seen for: large-for-gestational age (RR 2.87, 95% CI 0.61 to 13.50; 92 infants); caesarean section (RR 1.91, 95% CI 0.91 to 4.03; 92 women); or type 2 diabetes at three months postpartum (RR 0.76, 95% CI 0.11 to 5.01; 58 women).\nDiet recommendation plus diet-related behavioural advice versus diet recommendation only (one trial): no clear differences observed for: large-for-gestational age (RR 0.73, 95% CI 0.25 to 2.14; 99 infants); or caesarean section (RR 0.78, 95% CI 0.38 to 1.62; 99 women).\nSoy protein-enriched versus no soy protein diet (one trial): no clear differences seen for: pre-eclampsia (RR 2.00, 95% CI 0.19 to 21.03; 68 women); or caesarean section (RR 1.00, 95% CI 0.57 to 1.77; 68 women).\nHigh-fibre versus standard-fibre diet (one trial): no primary outcomes reported.\nEthnic-specific versus standard healthy diet (one trial): no clear differences observed for: large-for-gestational age (RR 0.14, 95% CI 0.01 to 2.45; 20 infants); neonatal composite adverse outcome (no events; 20 infants); gestational hypertension (RR 0.33, 95% CI 0.02 to 7.32; 20 women); or caesarean birth (RR 1.20, 95% CI 0.54 to 2.67; 20 women).\nSecondary outcomes\nFor secondary outcomes assessed using GRADE no differences were observed: between a low-moderate and moderate-high GI diet for induction of labour (RR 0.88, 95% CI 0.33 to 2.34; one trial, 63 women; low-quality evidence); or an energy-restricted and no energy-restricted diet for induction of labour (RR 1.02, 95% CI 0.68 to 1.53; one trial, 114 women, low-quality evidence) and neonatal hypoglycaemia (average RR 1.06, 95% CI 0.48 to 2.32; two trials, 408 infants; very low-quality evidence).\nFew other clear differences were observed for reported outcomes. Longer-term health outcomes and health services use and costs were largely not reported.\nAuthors' conclusions\nEvidence from 19 trials assessing different types of dietary advice for women with GDM suggests no clear differences for primary outcomes and secondary outcomes assessed using GRADE, except for a possible reduction in caesarean section for women receiving a DASH diet compared with a control diet. Few differences were observed for secondary outcomes.\nCurrent evidence is limited by the small number of trials in each comparison, small sample sizes, and variable methodological quality. More evidence is needed to assess the effects of different types of dietary advice for women with GDM. Future trials should be adequately powered to evaluate short- and long-term outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature on 8 March 2016 and for this updated review we included 19 randomised controlled trials involving 1398 women with GDM and their babies. The overall risk of bias of the trials was unclear or moderate because of methodological limitations and the quality of the evidence was low or very low. The studies were generally small, few compared the same or similar interventions, and the outcomes they reported on were not comprehensive.\nTen different dietary advice comparisons were included. These were: 1) a low-moderate glycaemic index (GI) diet with a moderate-high GI diet (four trials); 2) an energy-restricted diet with a diet with no energy restriction (three trials); 3) a 'Dietary Approaches to Stop Hypertension (DASH)' diet rich in fruits, vegetables, whole grains and low-fat dairy products with a control diet (three trials); 4) a low-carbohydrate diet with a high-carbohydrate diet (two trials); 5) a high unsaturated fat diet with a low unsaturated fat diet (two trials); 6) a low-GI diet with a high-fibre moderate-GI diet (one trial); 7) diet recommendations and diet-related behavioural advice with diet recommendations only (one trial); 8) a soy protein-enriched diet with a diet with no soy protein (one trial); 9) a high-fibre diet with a standard-fibre diet (one trial); and 10) an ethnic-specific diet with a standard healthy diet (one trial).\nThe review found no clear differences between the different types of dietary advice on the number of women with high blood pressure during pregnancy including pre-eclampsia (nine trials in six different diet comparisons), large-for-gestational age babies (eight trials in seven different diet comparisons), perinatal deaths including stillbirth and death around the time of the birth (three trials in two different diet comparisons), type 2 diabetes development for the mother (two trials in two different diet comparisons), and a composite outcome of neonatal deaths or ill-health (one trial in one diet comparison). No clear difference was seen in the number of babies delivered by caesarean section (10 trials in eight different diet comparisons) except for a reduction with a DASH diet. None of the included trials reported on later disability during childhood for the babies.\nA range of other outcomes were looked at with no consistent differences reported between the different types of dietary advice. Outcomes related to longer-term health for women and their babies, and the use and costs of health services were largely not reported."
}
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query-laysum | 5304 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in Issue 10, 2011. Paracetamol (acetaminophen) is the most commonly prescribed analgesic for the treatment of acute pain. It may be administered orally, rectally, or intravenously. The efficacy and safety of intravenous (IV) formulations of paracetamol, IV paracetamol, and IV propacetamol (a prodrug that is metabolized to paracetamol), compared with placebo and other analgesics, is unclear.\nObjectives\nTo assess the efficacy and safety of IV formulations of paracetamol for the treatment of postoperative pain in both adults and children.\nSearch methods\nWe ran the search for the previous review in May 2010. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 1), MEDLINE (May 2010 to 16 February 2016), EMBASE (May 2010 to 16 February 2016), LILACS (2010 to 2016), a clinical trials registry, and reference lists of reviews for randomized controlled trials (RCTs) in any language and we retrieved articles.\nSelection criteria\nRandomized, double-blind, placebo- or active-controlled single dose clinical trials of IV paracetamol or IV propacetamol for acute postoperative pain in adults or children.\nData collection and analysis\nTwo review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We contacted study authors for additional information. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence.\nMain results\nWe included 75 studies (36 from the original review and 39 from our updated review) enrolling a total of 7200 participants.\nAmong primary outcomes, 36% of participants receiving IV paracetamol/propacetamol experienced at least 50% pain relief over four hours compared with 16% of those receiving placebo (number needed to treat to benefit (NNT) = 5; 95% confidence interval (CI) 3.7 to 5.6, high quality evidence). The proportion of participants in IV paracetamol/propacetamol groups experiencing at least 50% pain relief diminished over six hours, as reflected in a higher NNT of 6 (4.6 to 7.1, moderate quality evidence). Mean pain intensity at four hours was similar when comparing IV paracetamol and placebo, but was seven points lower on a 0 to 100 visual analog scale (0 = no pain, 100 = worst pain imaginable, 95% CI -9 to -6, low quality evidence) in those receiving paracetamol at six hours.\nFor secondary outcomes, participants receiving IV paracetamol/propacetamol required 26% less opioid over four hours and 16% less over six hours (moderate quality evidence) than those receiving placebo. However, this did not translate to a clinically meaningful reduction in opioid-induced adverse events.\nMeta-analysis of efficacy comparisons between IV paracetamol/propacetamol and active comparators (e.g., opioids or nonsteroidal anti-inflammatory drugs) were either not statistically significant, not clinically significant, or both.\nAdverse events occurred at similar rates with IV paracetamol or IV propacetamol and placebo. However, pain on infusion occurred more frequently in those receiving IV propacetamol versus placebo (23% versus 1%). Meta-analysis did not demonstrate clinically meaningful differences between IV paracetamol/propacetamol and active comparators for any adverse event.\nAuthors' conclusions\nSince the last version of this review, we have found 39 new studies providing additional information. Most included studies evaluated adults only. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides high quality evidence that a single dose of either IV paracetamol or IV propacetamol provides around four hours of effective analgesia for about 36% of patients with acute postoperative pain. Low to very low quality evidence demonstrates that both formulations are associated with few adverse events, although patients receiving IV propacetamol have a higher incidence of pain on infusion than both placebo and IV paracetamol.\n\nGiven the provided abstract, please respond to the following query: \"Results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Our updated review included data from 75 studies of 7200 patients with moderate-to-severe pain after an operation. We found high quality evidence that IV paracetamol or IV propacetamol provided pain relief for four hours for about 36% of people versus 16% of those receiving placebo. Direct comparisons with other painkillers, such as morphine and anti-inflammatories, did not show large differences (if any) in effectiveness, although this may have been due to the small numbers of patients studied.\nLow quality evidence showed that IV paracetamol and IV propacetamol produced few side effects. However, patients receiving IV propacetamol complained of pain at the site their medication was infused at more often than those receiving placebo or IV paracetamol.\nDue to the amount of data already included in our review, we think it is unlikely that any new studies will change our conclusions. However, we found very few studies that included children, so this is an area that requires further investigation."
}
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query-laysum | 5305 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotics provide only modest benefit in treating sore throat, although their effectiveness increases in people with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated. This is an update of a review first published in 2010, and updated in 2013, 2016, and 2020.\nObjectives\nTo assess the comparative efficacy of different antibiotics in: (a) alleviating symptoms (pain, fever); (b) shortening the duration of the illness; (c) preventing clinical relapse (i.e. recurrence of symptoms after initial resolution); and (d) preventing complications (suppurative complications, acute rheumatic fever, post-streptococcal glomerulonephritis). To assess the evidence on the comparative incidence of adverse effects and the risk-benefit of antibiotic treatment for streptococcal pharyngitis.\nSearch methods\nWe searched the following databases up to 3 September 2020: CENTRAL (2020, Issue 8), MEDLINE Ovid (from 1946), Embase Elsevier (from 1974), and Web of Science Thomson Reuters (from 2010). We also searched clinical trial registers on 3 September 2020.\nSelection criteria\nRandomised, double-blind trials comparing different antibiotics, and reporting at least one of the following: clinical cure, clinical relapse, or complications and/or adverse events.\nData collection and analysis\nTwo review authors independently screened trials for inclusion and extracted data using standard methodological procedures as recommended by Cochrane. We assessed the risk of bias of included studies according to the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions, and used the GRADE approach to assess the overall certainty of the evidence for the outcomes. We have reported the intention-to-treat analysis, and also performed an analysis of evaluable participants to explore the robustness of the intention-to-treat results.\nMain results\nWe included 19 trials reported in 18 publications (5839 randomised participants): six trials compared penicillin with cephalosporins; six compared penicillin with macrolides; three compared penicillin with carbacephem; one compared penicillin with sulphonamides; one compared clindamycin with ampicillin; and one compared azithromycin with amoxicillin in children. All participants had confirmed acute GABHS tonsillopharyngitis, and ages ranged from one month to 80 years. Nine trials included only, or predominantly, children. Most trials were conducted in an outpatient setting. Reporting of randomisation, allocation concealment, and blinding was poor in all trials. We downgraded the certainty of the evidence mainly due to lack of (or poor reporting of) randomisation or blinding, or both; heterogeneity; and wide confidence intervals.\nCephalosporins versus penicillin\nWe are uncertain if there is a difference in symptom resolution (at 2 to 15 days) for cephalosporins versus penicillin (odds ratio (OR) for absence of symptom resolution 0.79, 95% confidence interval (CI) 0.55 to 1.12; 5 trials; 2018 participants; low-certainty evidence). Results of the sensitivity analysis of evaluable participants differed (OR 0.51, 95% CI 0.27 to 0.97; 5 trials; 1660 participants; very low-certainty evidence). We are uncertain if clinical relapse may be lower for cephalosporins compared with penicillin (OR 0.55, 95% CI 0.30 to 0.99; number needed to treat for an additional beneficial outcome (NNTB) 50; 4 trials; 1386 participants; low-certainty evidence). Very low-certainty evidence showed no difference in reported adverse events.\nMacrolides versus penicillin\nWe are uncertain if there is a difference between macrolides and penicillin for resolution of symptoms (OR 1.11, 95% CI 0.92 to 1.35; 6 trials; 1728 participants; low-certainty evidence). Sensitivity analysis of evaluable participants resulted in an OR of 0.79, 95% CI 0.57 to 1.09; 6 trials; 1159 participants). We are uncertain if clinical relapse may be different (OR 1.21, 95% CI 0.48 to 3.03; 6 trials; 802 participants; low-certainty evidence).\nAzithromycin versus amoxicillin\nBased on one unpublished trial in children, we are uncertain if resolution of symptoms is better with azithromycin in a single dose versus amoxicillin for 10 days (OR 0.76, 95% CI 0.55 to 1.05; 1 trial; 673 participants; very low-certainty evidence). Sensitivity analysis for per-protocol analysis resulted in an OR of 0.29, 95% CI 0.11 to 0.73; 1 trial; 482 participants; very low-certainty evidence). We are also uncertain if there was a difference in relapse between groups (OR 0.88, 95% CI 0.43 to 1.82; 1 trial; 422 participants; very low-certainty evidence). Adverse events were more common with azithromycin compared to amoxicillin (OR 2.67, 95% CI 1.78 to 3.99; 1 trial; 673 participants; very low-certainty evidence).\nCarbacephem versus penicillin\nThere is low-certainty evidence that compared with penicillin, carbacephem may provide better symptom resolution post-treatment in adults and children (OR 0.70, 95% CI 0.49 to 0.99; NNTB 14.3; 3 trials; 795 participants).\nStudies did not report on long-term complications, so it was unclear if any class of antibiotics was better in preventing serious but rare complications.\nAuthors' conclusions\nWe are uncertain if there are clinically relevant differences in symptom resolution when comparing cephalosporins and macrolides with penicillin in the treatment of GABHS tonsillopharyngitis. Low-certainty evidence in children suggests that carbacephem may be more effective than penicillin for symptom resolution. There is insufficient evidence to draw conclusions regarding the other comparisons in this review. Data on complications were too scarce to draw conclusions. These results do not demonstrate that other antibiotics are more effective than penicillin in the treatment of GABHS pharyngitis. All studies were conducted in high-income countries with a low risk of streptococcal complications, so there is a need for trials in low-income countries and Aboriginal communities, where the risk of complications remains high.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Twelve trials reported funding from drug companies. Authors of six trials (in five publications) were employed by drug companies. Seven trials (in six publications) did not report funding sources."
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query-laysum | 5306 | [
{
"role": "user",
"content": "Abstract: Background\nInfants born at term by elective caesarean section are more likely to develop respiratory morbidity than infants born vaginally. Prophylactic corticosteroids in singleton preterm pregnancies accelerate lung maturation and reduce the incidence of respiratory complications. It is unclear whether administration at term gestations, prior to caesarean section, improves the respiratory outcomes for these babies without causing any unnecessary morbidity to the mother or the infant.\nObjectives\nThe objective of this review was to assess the effect of prophylactic corticosteroid administration before elective caesarean section at term, as compared to usual care (which could be placebo or no treatment), on fetal, neonatal and maternal morbidity. We also assessed the impact of the treatment on the child in later life.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov (20 January 2021) and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials comparing prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone) with placebo or with no treatment, given before elective caesarean section at term (at or after 37 weeks of gestation). Quasi-randomised and cluster-randomised controlled trials were also eligible for inclusion.\nData collection and analysis\nWe used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two review authors independently assessed trials for inclusion, assessed risk of bias, evaluated trustworthiness (based on predefined criteria developed by Cochrane Pregnancy and Childbirth), extracted data and checked them for accuracy and assessed the certainty of the evidence using the GRADE approach. Our primary outcomes were respiratory distress syndrome (RDS), transient tachypnoea of the neonate (TTN), admission to neonatal special care for respiratory morbidity and need for mechanical ventilation.\nWe planned to perform subgroup analyses for the primary outcomes according to gestational age at randomisation and type of corticosteroid (betamethasone or dexamethasone). We also planned to perform sensitivity analysis, including only studies at low risk of bias.\nMain results\nWe included one trial in which participants were randomised to receive either betamethasone or usual care. The trial included 942 women and 942 neonates recruited from 10 UK hospitals between 1995 and 2002. This review includes only trials that met predefined criteria for trustworthiness. We removed three trials from the analysis that were included in the previous version of this review.\nThe risk of bias was low for random sequence generation, allocation concealment and incomplete outcome data. The risk of bias for selective outcome reporting was unclear because there was no published trial protocol, and therefore it is unclear whether all the planned outcomes were reported in full. Due to a lack of blinding we judged there to be high risk of performance bias and detection bias. We downgraded the certainty of the evidence because of concerns about risk of bias and because of imprecision due to low event rates and wide 95% confidence intervals (CIs), which are consistent with possible benefit and possible harm\nCompared with usual care, it is uncertain if antenatal corticosteroids reduce the risk of RDS (relative risk (RR) 0.34 95% CI 0.07 to 1.65; 1 study; 942 infants) or TTN (RR 0.52, 95% CI 0.25 to 1.11; 1 study; 938 infants) because the certainty of evidence is low and the 95% CIs are consistent with possible benefit and possible harm.\nAntenatal corticosteroids probably reduce the risk of admission to neonatal special care for respiratory complications, compared with usual care (RR 0.45, 95% CI 0.22 to 0.90; 1 study; 942 infants; moderate-certainty evidence). The proportion of infants admitted to neonatal special care for respiratory morbidity after treatment with antenatal corticosteroids was 2.3% compared with 5.1% in the usual care group.\nIt is uncertain if antenatal steroids have any effect on the risk of needing mechanical ventilation, compared with usual care (RR 4.07, 95% CI 0.46 to 36.27; 1 study; 942 infants; very low-certainty evidence). The effect of antenatal corticosteroids on the maternal development of postpartum infection/pyrexia in the first 72 hours is unclear due to the very low certainty of the evidence; one study (942 women) reported zero cases. The included studies did not report any data for neonatal hypoglycaemia or maternal mortality/severe morbidity.\nAuthors' conclusions\nEvidence from one randomised controlled trial suggests that prophylactic corticosteroids before elective caesarean section at term probably reduces admission to the neonatal intensive care unit for respiratory morbidity. It is uncertain if administration of antenatal corticosteroids reduces the rates of respiratory distress syndrome (RDS) or transient tachypnoea of the neonate (TTN). The overall certainty of the evidence for the primary outcomes was found to be low or very low, apart from the outcome of admission to neonatal special care (all levels) for respiratory morbidity, for which the evidence was of moderate certainty. Therefore, there is currently insufficient data to draw any firm conclusions.\nMore evidence is needed to investigate the effect of prophylactic antenatal corticosteroids on the incidence of recognised respiratory morbidity such as RDS. Any future trials should assess the balance between respiratory benefit and potential immediate adverse effects (e.g. hypoglycaemia) and long-term adverse effects (e.g. academic performance) for the infant. There is very limited information on maternal health outcomes to provide any assurances that corticosteroids do not pose any increased risk of harm to the mother.\nFurther research should consider investigating the effectiveness of antenatal steroids at different gestational ages prior to caesarean section. There are nine potentially eligible studies that are currently ongoing and could be included in future updates of this review.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature for randomised controlled studies that met our criteria for being trustworthy and compared the effects of corticosteroids against a placebo (dummy) treatment or against usual care. We rated our confidence in the findings based on factors such as the number of studies, study methods, number of women and babies involved, the number of events and the variability of the findings."
}
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query-laysum | 5307 | [
{
"role": "user",
"content": "Abstract: Background\nSurgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition, surgeons can choose to close the incision in anatomic layers or mass ('en masse'), as well as using either a continuous or interrupted suturing technique, of which there are different styles of each. There is ongoing debate as to which suturing techniques and suture materials are best for achieving definitive wound closure while minimising the risk of short- and long-term complications.\nObjectives\nThe objectives of this review were to identify the best available suture techniques and suture materials for closure of the fascia following laparotomy incisions, by assessing the following comparisons: absorbable versus non-absorbable sutures; mass versus layered closure; continuous versus interrupted closure techniques; monofilament versus multifilament sutures; and slow absorbable versus fast absorbable sutures. Our objective was not to determine the single best combination of suture material and techniques, but to compare the individual components of abdominal closure.\nSearch methods\nOn 8 February 2017 we searched CENTRAL, MEDLINE, Embase, two trials registries, and Science Citation Index. There were no limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that our searches may have missed.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared suture materials or closure techniques, or both, for fascial closure of laparotomy incisions. We excluded trials that compared only types of skin closures, peritoneal closures or use of retention sutures.\nData collection and analysis\nWe abstracted data and assessed the risk of bias for each trial. We calculated a summary risk ratio (RR) for the outcomes assessed in the review, all of which were dichotomous. We used random-effects modelling, based on the heterogeneity seen throughout the studies and analyses. We completed subgroup analysis planned a priori for each outcome, excluding studies where interventions being compared differed by more than one component, making it impossible to determine which variable impacted on the outcome, or the possibility of a synergistic effect. We completed sensitivity analysis, excluding trials with at least one trait with high risk of bias. We assessed the quality of evidence using the GRADEpro guidelines.\nMain results\nFifty-five RCTs with a total of 19,174 participants met the inclusion criteria and were included in the meta-analysis. Included studies were heterogeneous in the type of sutures used, methods of closure and patient population. Many of the included studies reported multiple comparisons.\nFor our primary outcome, the proportion of participants who developed incisional hernia at one year or more of follow-up, we did not find evidence that suture absorption (absorbable versus non-absorbable sutures, RR 1.07, 95% CI 0.86 to 1.32, moderate-quality evidence; or slow versus fast absorbable sutures, RR 0.81, 95% CI 0.63 to 1.06, moderate-quality evidence), closure method (mass versus layered, RR 1.92, 95% CI 0.58 to 6.35, very low-quality evidence) or closure technique (continuous versus interrupted, RR 1.01, 95% CI 0.76 to 1.35, moderate-quality evidence) resulted in a difference in the risk of incisional hernia. We did, however, find evidence to suggest that monofilament sutures reduced the risk of incisional hernia when compared with multifilament sutures (RR 0.76, 95% CI 0.59 to 0.98, I2 = 30%, moderate-quality evidence).\nFor our secondary outcomes, we found that none of the interventions reduced the risk of wound infection, whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.99, 95% CI 0.84 to 1.17, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.16, 95% CI 0.85 to 1.57, moderate-quality evidence), closure method (mass versus layered, RR 0.93, 95% CI 0.67 to 1.30, low-quality evidence) or closure technique (continuous versus interrupted, RR 1.13, 95% CI 0.96 to 1.34, moderate-quality evidence).\nSimilarily, none of the interventions reduced the risk of wound dehiscence whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.78, 95% CI 0.55 to 1.10, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.55, 95% CI 0.92 to 2.61, moderate-quality evidence), closure method (mass versus layered, RR 0.69, 95% CI 0.31 to 1.52, moderate-quality evidence) or closure technique (continuous versus interrupted, RR 1.21, 95% CI 0.90 to 1.64, moderate-quality evidence).\nAbsorbable sutures, compared with non-absorbable sutures (RR 0.49, 95% CI 0.26 to 0.94, low-quality evidence) reduced the risk of sinus or fistula tract formation. None of the other comparisons showed a difference (slow versus fast absorbable sutures, RR 0.88, 95% CI 0.05 to 16.05, very low-quality evidence; mass versus layered, RR 0.49, 95% CI 0.15 to 1.62, low-quality evidence; continuous versus interrupted, RR 1.51, 95% CI 0.64 to 3.61, very low-quality evidence).\nAuthors' conclusions\nBased on this moderate-quality body of evidence, monofilament sutures may reduce the risk of incisional hernia. Absorbable sutures may also reduce the risk of sinus or fistula tract formation, but this finding is based on low-quality evidence.\nWe had serious concerns about the design or reporting of several of the 55 included trials. The comparator arms in many trials differed by more than one component, making it impossible to attribute differences between groups to any one component. In addition, the patient population included in many of the studies was very heterogeneous. Trials included both emergency and elective cases, different types of disease pathology (e.g. colon surgery, hepatobiliary surgery, etc.) or different types of incisions (e.g. midline, paramedian, subcostal).\nConsequently, larger, high-quality trials to further address this clinical challenge are warranted. Future studies should ensure that proper randomisation and allocation techniques are performed, wound assessors are blinded, and that the duration of follow-up is adequate. It is important that only one type of intervention is compared between groups. In addition, a homogeneous patient population would allow for a more accurate assessment of the interventions.\n\nGiven the provided abstract, please respond to the following query: \"This means\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Monofilament sutures can be considered for abdominal closure to reduce the risk of incisional hernia. Absorbable sutures can be considered to reduce the risk of chronic drainage from the wound."
}
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query-laysum | 5308 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in Issue 5, 2015.\nCervical cancer is the fourth most common cancer among women worldwide, with estimated 569,847 new diagnoses and 311,365 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.\nThus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed to inform decision-making.\nObjectives\nTo evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer.\nSearch methods\nThe search for the original review was run in 23 March 2015, and subsequent searches for this update were run 21 March 2018. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid to March week 2, 2018; and Embase via Ovid to March week 12, 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles, and contacted experts in the field. We handsearched citation lists of relevant studies.\nSelection criteria\nWe searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review.\nData collection and analysis\nTwo review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies for inclusion and, therefore, we analysed no data.\nMain results\nThe search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer.\nAuthors' conclusions\nSince the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "the aim of this review was to compare tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions versus radiotherapy treatment to control vaginal bleeding in cervical cancer."
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query-laysum | 5309 | [
{
"role": "user",
"content": "Abstract: Background\nRepetitive task training (RTT) involves the active practice of task-specific motor activities and is a component of current therapy approaches in stroke rehabilitation.\nObjectives\nPrimary objective: To determine if RTT improves upper limb function/reach and lower limb function/balance in adults after stroke.\n\nSecondary objectives: 1) To determine the effect of RTT on secondary outcome measures including activities of daily living, global motor function, quality of life/health status and adverse events. 2) To determine the factors that could influence primary and secondary outcome measures, including the effect of 'dose' of task practice; type of task (whole therapy, mixed or single task); timing of the intervention and type of intervention.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (4 March 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 5: 1 October 2006 to 24 June 2016); MEDLINE (1 October 2006 to 8 March 2016); Embase (1 October 2006 to 8 March 2016); CINAHL (2006 to 23 June 2016); AMED (2006 to 21 June 2016) and SPORTSDiscus (2006 to 21 June 2016).\nSelection criteria\nRandomised/quasi-randomised trials in adults after stroke, where the intervention was an active motor sequence performed repetitively within a single training session, aimed towards a clear functional goal.\nData collection and analysis\nTwo review authors independently screened abstracts, extracted data and appraised trials. We determined the quality of evidence within each study and outcome group using the Cochrane 'Risk of bias' tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. We did not assess follow-up outcome data using GRADE. We contacted trial authors for additional information.\nMain results\nWe included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system.\nThere is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419).\nThere is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events.\nAuthors' conclusions\nThere is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We identified 33 studies with 1853 participants. Studies included a wide range of tasks to practice, including lifting a ball, walking, standing up from sitting and circuit training with a different task at each station. The evidence is current to June 2016."
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query-laysum | 5310 | [
{
"role": "user",
"content": "Abstract: Background\nMeibomian gland dysfunction (MGD) is the major cause of evaporative dry eye disease, which is the more prevalent form of dry eye disease. Intense pulsed light (IPL) therapy, involving treatment of the skin near the eyelids, has emerged as a potential treatment for MGD.\nObjectives\nTo evaluate the effectiveness and safety of intense pulsed light (IPL) for the management dry eye disease resulting from meibomian gland dysfunction (MGD).\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase Ovid and three trial registers for eligible clinical trials on 1 August 2019. There were no restrictions on publication status, date or language.\nSelection criteria\nWe included randomised controlled trials (RCTs) studying the effectiveness or safety of IPL for treating MGD.\nData collection and analysis\nOur outcomes of interest were the change from baseline in subjective dry eye symptoms, adverse events, changes to lipid layer thickness, tear break-up time (TBUT), tear osmolarity, eyelid irregularity, eyelid telangiectasia, meibomian gland orifice plugging, meibomian gland dropout, corneal sodium fluorescein staining and conjunctival lissamine green staining.\nTwo review authors independently screened abstracts and full-text articles, extracted data from eligible RCTs and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE Working Group approach.\nMain results\nWe included three RCTs, one from New Zealand, one from Japan and one from China, published between 2015 and 2019. Together, these trials enrolled 114 adults (228 eyes). Two studies used a paired-eye (inter-eye comparison) design to evaluate the effects of a sham (control) IPL treatment relative to an actual IPL treatment. One study randomised individuals to either an IPL intervention combined with meibomian gland expression (MGX), or MGX alone (standard therapy). The study follow-up periods ranged from 45 days to nine months. None of the trials were at low risk of bias in all seven domains. The first authors of two included studies were in receipt of funding from patents or the manufacturers of IPL devices. The funding sources and declaration of interests were not given in the report of the third included trial.\nAll three trials evaluated the effect of IPL on dry eye symptoms, quantified using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. Pooling data from two trials that used a paired-eye design, the summary estimate for these studies indicated little to no reduction in dry eye symptoms with IPL relative to a sham intervention (mean difference (MD) –0.33 units, 95% confidence interval (CI) –2.56 to 1.89; I² = 0%; 2 studies, 144 eyes). The other study was not pooled as it had a unit-of-analysis error, but reported a reduction in symptoms in favour of IPL (MD –4.60, 95% CI –6.72 to –2.48; 84 eyes). The body of evidence for this outcome was of very low certainty, so we are uncertain about the effect of IPL on dry eye symptoms.\nThere were no relevant combinable data for any of the other secondary outcomes, thus the effect of IPL on clinical parameters relevant to dry eye disease are currently unclear.\nFor sodium fluorescein TBUT, two studies indicated that there may be an improvement in favour of IPL (MD 2.02 seconds, 95% CI 0.87 to 3.17; MD 2.40 seconds, 95% CI 2.27 to 2.53; 172 eyes total; low-certainty evidence).\nWe are uncertain of the effect of IPL on non-invasive tear break-up time (MD 5.51 seconds, 95% CI 0.79 to 10.23; MD 3.20, 95% CI 3.09 to 3.31 seconds; two studies; 140 eyes total; very low-certainty evidence).\nFor tear osmolarity, one study indicated that there may be an improvement in favour of IPL (MD –7.00 mOsmol/L, 95% –12.97 to –1.03; 56 eyes; low-certainty evidence).\nWe are uncertain of the effect of IPL on meibomian gland orifice plugging (MD –1.20 clinical units, 95% CI –1.24 to –1.16; 84 eyes; very low-certainty evidence).\nWe are uncertain of the effect of IPL on corneal sodium fluorescein staining. One study reported no evidence of a difference between the IPL and sham intervention arms at three months of follow-up (P = 0.409), and a second study reported data favouring IPL (MD –1.00 units, 95% CI –1.07 to –0.93 units; 172 eyes in total; very low-certainty evidence).\nWe considered the incidence of adverse events at the study endpoint, as a measure of safety. As most trials did not specifically report adverse events, the safety of IPL as a treatment for MGD could also not be determined with any certainty. Very low-certainty results from individual studies suggest some adverse effects that may be experienced by participants, include mild pain and burning, and the potential for partially losing eyelashes (due to clinician error).\nAuthors' conclusions\nThis systematic review finds a scarcity of RCT evidence relating to the effectiveness and safety of IPL as a treatment for MGD. Whether IPL is of value for modifying the symptoms or signs of evaporative dry eye disease is currently uncertain. Due to a lack of comprehensive reporting of adverse events, the safety profile of IPL in this patient population is also unclear. The current limitations in the evidence base should be considered by clinicians using this intervention to treat MGD, and outlined to individuals potentially undergoing this procedure with the intent of treating dry eye disease.\nThe results of the 14 RCTs currently in progress will be of major importance for establishing a more definitive answer regarding the effectiveness and safety of IPL for treating MGD. We intend to update this review when results from these trials become available.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we searched for studies that had been published up to 1 August 2019. We identified three randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) involving 114 adults (228 eyes) from three countries (New Zealand, Japan and China) that had been published between 2015 and 2019. The maximum time that people in the studies were followed up for after the treatment was nine months."
}
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query-laysum | 5311 | [
{
"role": "user",
"content": "Abstract: Background\nIn late 2019, the first cases of coronavirus disease 2019 (COVID-19) were reported in Wuhan, China, followed by a worldwide spread. Numerous countries have implemented control measures related to international travel, including border closures, travel restrictions, screening at borders, and quarantine of travellers.\nObjectives\nTo assess the effectiveness of international travel-related control measures during the COVID-19 pandemic on infectious disease transmission and screening-related outcomes.\nSearch methods\nWe searched MEDLINE, Embase and COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO Global Database on COVID-19 Research to 13 November 2020.\nSelection criteria\nWe considered experimental, quasi-experimental, observational and modelling studies assessing the effects of travel-related control measures affecting human travel across international borders during the COVID-19 pandemic. In the original review, we also considered evidence on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In this version we decided to focus on COVID-19 evidence only. Primary outcome categories were (i) cases avoided, (ii) cases detected, and (iii) a shift in epidemic development. Secondary outcomes were other infectious disease transmission outcomes, healthcare utilisation, resource requirements and adverse effects if identified in studies assessing at least one primary outcome.\nData collection and analysis\nTwo review authors independently screened titles and abstracts and subsequently full texts. For studies included in the analysis, one review author extracted data and appraised the study. At least one additional review author checked for correctness of data. To assess the risk of bias and quality of included studies, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for observational studies concerned with screening, and a bespoke tool for modelling studies. We synthesised findings narratively. One review author assessed the certainty of evidence with GRADE, and several review authors discussed these GRADE judgements.\nMain results\nOverall, we included 62 unique studies in the analysis; 49 were modelling studies and 13 were observational studies. Studies covered a variety of settings and levels of community transmission.\nMost studies compared travel-related control measures against a counterfactual scenario in which the measure was not implemented. However, some modelling studies described additional comparator scenarios, such as different levels of stringency of the measures (including relaxation of restrictions), or a combination of measures.\nConcerns with the quality of modelling studies related to potentially inappropriate assumptions about the structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to the selection of travellers and the reference test, and unclear reporting of certain methodological aspects.\nBelow we outline the results for each intervention category by illustrating the findings from selected outcomes.\nTravel restrictions reducing or stopping cross-border travel (31 modelling studies)\nThe studies assessed cases avoided and shift in epidemic development. We found very low-certainty evidence for a reduction in COVID-19 cases in the community (13 studies) and cases exported or imported (9 studies). Most studies reported positive effects, with effect sizes varying widely; only a few studies showed no effect.\nThere was very low-certainty evidence that cross-border travel controls can slow the spread of COVID-19. Most studies predicted positive effects, however, results from individual studies varied from a delay of less than one day to a delay of 85 days; very few studies predicted no effect of the measure.\nScreening at borders (13 modelling studies; 13 observational studies)\nScreening measures covered symptom/exposure-based screening or test-based screening (commonly specifying polymerase chain reaction (PCR) testing), or both, before departure or upon or within a few days of arrival. Studies assessed cases avoided, shift in epidemic development and cases detected. Studies generally predicted or observed some benefit from screening at borders, however these varied widely.\nFor symptom/exposure-based screening, one modelling study reported that global implementation of screening measures would reduce the number of cases exported per day from another country by 82% (95% confidence interval (CI) 72% to 95%) (moderate-certainty evidence). Four modelling studies predicted delays in epidemic development, although there was wide variation in the results between the studies (very low-certainty evidence). Four modelling studies predicted that the proportion of cases detected would range from 1% to 53% (very low-certainty evidence). Nine observational studies observed the detected proportion to range from 0% to 100% (very low-certainty evidence), although all but one study observed this proportion to be less than 54%.\nFor test-based screening, one modelling study provided very low-certainty evidence for the number of cases avoided. It reported that testing travellers reduced imported or exported cases as well as secondary cases. Five observational studies observed that the proportion of cases detected varied from 58% to 90% (very low-certainty evidence).\nQuarantine (12 modelling studies)\nThe studies assessed cases avoided, shift in epidemic development and cases detected. All studies suggested some benefit of quarantine, however the magnitude of the effect ranged from small to large across the different outcomes (very low- to low-certainty evidence). Three modelling studies predicted that the reduction in the number of cases in the community ranged from 450 to over 64,000 fewer cases (very low-certainty evidence). The variation in effect was possibly related to the duration of quarantine and compliance.\nQuarantine and screening at borders (7 modelling studies; 4 observational studies)\nThe studies assessed shift in epidemic development and cases detected. Most studies predicted positive effects for the combined measures with varying magnitudes (very low- to low-certainty evidence). Four observational studies observed that the proportion of cases detected for quarantine and screening at borders ranged from 68% to 92% (low-certainty evidence). The variation may depend on how the measures were combined, including the length of the quarantine period and days when the test was conducted in quarantine.\nAuthors' conclusions\nWith much of the evidence derived from modelling studies, notably for travel restrictions reducing or stopping cross-border travel and quarantine of travellers, there is a lack of 'real-world' evidence. The certainty of the evidence for most travel-related control measures and outcomes is very low and the true effects are likely to be substantially different from those reported here. Broadly, travel restrictions may limit the spread of disease across national borders. Symptom/exposure-based screening measures at borders on their own are likely not effective; PCR testing at borders as a screening measure likely detects more cases than symptom/exposure-based screening at borders, although if performed only upon arrival this will likely also miss a meaningful proportion of cases. Quarantine, based on a sufficiently long quarantine period and high compliance is likely to largely avoid further transmission from travellers. Combining quarantine with PCR testing at borders will likely improve effectiveness. Many studies suggest that effects depend on factors, such as levels of community transmission, travel volumes and duration, other public health measures in place, and the exact specification and timing of the measure. Future research should be better reported, employ a range of designs beyond modelling and assess potential benefits and harms of the travel-related control measures from a societal perspective.\n\nGiven the provided abstract, please respond to the following query: \"Screening at borders\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "(13 modelling studies and 13 observational studies)\nThese studies assessed screening at borders, including screening people with symptoms or who had potentially been exposed to COVID-19, or testing people, before or after they travelled.\nFor screening based on symptoms or potential exposure to COVID-19, modelling studies found that screening reduced imported or exported cases and delayed outbreaks. Modelling studies predicted that 1% to 53% of cases would be detected. Observational studies reported a wide range of cases detected, from 0% to 100%, with the majority of studies reporting less than 54% of cases detected.\nFor screening based on testing, studies reported that testing travellers reduced imported or exported cases, and cases detected. Observational studies reported that the proportion of cases detected varied from 58% to 90%. This variation might be due to the timing of testing."
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query-laysum | 5312 | [
{
"role": "user",
"content": "Abstract: Background\nEvery year, an estimated one million children and young adolescents become ill with tuberculosis, and around 226,000 of those children die. Xpert MTB/RIF Ultra (Xpert Ultra) is a molecular World Health Organization (WHO)-recommended rapid diagnostic test that simultaneously detects Mycobacterium tuberculosis complex and rifampicin resistance. We previously published a Cochrane Review 'Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for tuberculosis disease and rifampicin resistance in children'. The current review updates evidence on the diagnostic accuracy of Xpert Ultra in children presumed to have tuberculosis disease. Parts of this review update informed the 2022 WHO updated guidance on management of tuberculosis in children and adolescents.\nObjectives\nTo assess the diagnostic accuracy of Xpert Ultra for detecting: pulmonary tuberculosis, tuberculous meningitis, lymph node tuberculosis, and rifampicin resistance, in children with presumed tuberculosis.\nSecondary objectives\nTo investigate potential sources of heterogeneity in accuracy estimates. For detection of tuberculosis, we considered age, comorbidity (HIV, severe pneumonia, and severe malnutrition), and specimen type as potential sources.\nTo summarize the frequency of Xpert Ultra trace results.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, three other databases, and three trial registers without language restrictions to 9 March 2021.\nSelection criteria\nCross-sectional and cohort studies and randomized trials that evaluated Xpert Ultra in HIV-positive and HIV-negative children under 15 years of age. We included ongoing studies that helped us address the review objectives. We included studies evaluating sputum, gastric, stool, or nasopharyngeal specimens (pulmonary tuberculosis), cerebrospinal fluid (tuberculous meningitis), and fine needle aspirate or surgical biopsy tissue (lymph node tuberculosis). For detecting tuberculosis, reference standards were microbiological (culture) or composite reference standard; for stool, we also included Xpert Ultra performed on a routine respiratory specimen. For detecting rifampicin resistance, reference standards were drug susceptibility testing or MTBDRplus.\nData collection and analysis\nTwo review authors independently extracted data and, using QUADAS-2, assessed methodological quality judging risk of bias separately for each target condition and reference standard. For each target condition, we used the bivariate model to estimate summary sensitivity and specificity with 95% confidence intervals (CIs). We stratified all analyses by type of reference standard. We summarized the frequency of Xpert Ultra trace results; trace represents detection of a very low quantity of Mycobacterium tuberculosis DNA. We assessed certainty of evidence using GRADE.\nMain results\nWe identified 14 studies (11 new studies since the previous review). For detection of pulmonary tuberculosis, 335 data sets (25,937 participants) were available for analysis. We did not identify any studies that evaluated Xpert Ultra accuracy for tuberculous meningitis or lymph node tuberculosis. Three studies evaluated Xpert Ultra for detection of rifampicin resistance. Ten studies (71%) took place in countries with a high tuberculosis burden based on WHO classification. Overall, risk of bias was low.\nDetection of pulmonary tuberculosis\nSputum, 5 studies\nXpert Ultra summary sensitivity verified by culture was 75.3% (95% CI 64.3 to 83.8; 127 participants; high-certainty evidence), and specificity was 97.1% (95% CI 94.7 to 98.5; 1054 participants; high-certainty evidence).\nGastric aspirate, 7 studies\nXpert Ultra summary sensitivity verified by culture was 70.4% (95% CI 53.9 to 82.9; 120 participants; moderate-certainty evidence), and specificity was 94.1% (95% CI 84.8 to 97.8; 870 participants; moderate-certainty evidence).\nStool, 6 studies\nXpert Ultra summary sensitivity verified by culture was 56.1% (95% CI 39.1 to 71.7; 200 participants; moderate-certainty evidence), and specificity was 98.0% (95% CI 93.3 to 99.4; 1232 participants; high certainty-evidence).\nNasopharyngeal aspirate, 4 studies\nXpert Ultra summary sensitivity verified by culture was 43.7% (95% CI 26.7 to 62.2; 46 participants; very low-certainty evidence), and specificity was 97.5% (95% CI 93.6 to 99.0; 489 participants; high-certainty evidence).\nXpert Ultra sensitivity was lower against a composite than a culture reference standard for all specimen types other than nasopharyngeal aspirate, while specificity was similar against both reference standards.\nInterpretation of results\nIn theory, for a population of 1000 children:\n• where 100 have pulmonary tuberculosis in sputum (by culture):\n- 101 would be Xpert Ultra-positive, and of these, 26 (26%) would not have pulmonary tuberculosis (false positive); and\n- 899 would be Xpert Ultra-negative, and of these, 25 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in gastric aspirate (by culture):\n- 123 would be Xpert Ultra-positive, and of these, 53 (43%) would not have pulmonary tuberculosis (false positive); and\n- 877 would be Xpert Ultra-negative, and of these, 30 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in stool (by culture):\n- 74 would be Xpert Ultra-positive, and of these, 18 (24%) would not have pulmonary tuberculosis (false positive); and\n- 926 would be Xpert Ultra-negative, and of these, 44 (5%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in nasopharyngeal aspirate (by culture):\n- 66 would be Xpert Ultra-positive, and of these, 22 (33%) would not have pulmonary tuberculosis (false positive); and\n- 934 would be Xpert Ultra-negative, and of these, 56 (6%) would have tuberculosis (false negative).\nDetection of rifampicin resistance\nXpert Ultra sensitivity was 100% (3 studies, 3 participants; very low-certainty evidence), and specificity range was 97% to 100% (3 studies, 128 participants; low-certainty evidence).\nTrace results\nXpert Ultra trace results, regarded as positive in children by WHO standards, were common. Xpert Ultra specificity remained high in children, despite the frequency of trace results.\nAuthors' conclusions\nWe found Xpert Ultra sensitivity to vary by specimen type, with sputum having the highest sensitivity, followed by gastric aspirate and stool. Nasopharyngeal aspirate had the lowest sensitivity. Xpert Ultra specificity was high against both microbiological and composite reference standards. However, the evidence base is still limited, and findings may be imprecise and vary by study setting. Although we found Xpert Ultra accurate for detection of rifampicin resistance, results were based on a very small number of studies that included only three children with rifampicin resistance. Therefore, findings should be interpreted with caution. Our findings provide support for the use of Xpert Ultra as an initial rapid molecular diagnostic in children being evaluated for tuberculosis.\n\nGiven the provided abstract, please respond to the following query: \"What did this review study?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Xpert Ultra, a World Health Organization-recommended rapid test that simultaneously detects tuberculosis and rifampicin resistance in adults and children with tuberculosis symptoms. Rifampicin is an important medicine used to treat tuberculosis. For tuberculosis diagnosis, we assessed results against two different benchmarks: tuberculosis culture (a method used to grow bacteria on nutrient-rich media) and a composite definition based on symptoms, chest X-ray, sputum microscopy (examination under a microscope of mucus and other matter coughed up from the lungs), and culture. For rifampicin resistance detection, we assessed results against drug susceptibility testing or line probe assay (a rapid laboratory-based test for detecting tuberculosis bacteria)."
}
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query-laysum | 5313 | [
{
"role": "user",
"content": "Abstract: Background\nEnteral tube feeding is routinely used in many cystic fibrosis centres when oral dietary and supplement intake has failed to achieve an adequate nutritional status. The use of this method of feeding is assessed on an individual basis taking into consideration the patients age and clinical status. This is a final update of a previously published review.\nObjectives\nTo examine the evidence that in people with cystic fibrosis, supplemental enteral tube feeding improves nutritional status, respiratory function, and quality of life without significant adverse effects.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also contacted the companies that market enteral feeds and reviewed their databases.\nDate of the most recent search of the Group's Cystic Fibrosis Trials Register: 10 July 2019.\nDate of the most recent hand search of PubMed: 26 October 2018.\nSelection criteria\nAll randomised controlled trials comparing supplemental enteral tube feeding for one month or longer with no specific intervention in people with cystic fibrosis.\nData collection and analysis\nThe searches identified 44 trials; however, none were eligible for inclusion in this review.\nMain results\nThere are no trials included in this review.\nAuthors' conclusions\nSupplemental enteral tube feeding is widely used throughout the world to improve nutritional status in people with cystic fibrosis. The methods mostly used, nasogastric or gastrostomy feeding, are expensive and may have a negative effect on self-esteem and body image. Reported use of enteral tube feeding suggests that it results in nutritional and respiratory improvement; but, efficacy has not been fully assessed by randomised controlled trials. It is acknowledged, however, that performing a randomised controlled trial would be difficult due to the ethics of withholding an intervention in a group of people whose nutritional status necessitates it.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 44 trials in our searches, but none matched the design and duration of the trials we wanted to examine. We therefore did not include any trials in this review."
}
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query-laysum | 5314 | [
{
"role": "user",
"content": "Abstract: Background\nEpistaxis (nosebleed) most commonly affects children and the elderly. The majority of episodes are managed at home with simple measures. In more severe cases medical intervention is required to either cauterise the bleeding vessel, or to pack the nose with various materials. Tranexamic acid is used in a number of clinical settings to stop bleeding by preventing clot breakdown (fibrinolysis). It may have a role in the management of epistaxis as an adjunct to standard treatments, reducing the need for further intervention.\nObjectives\nTo determine the effects of tranexamic acid (oral, intravenous or topical) compared with placebo, no additional intervention or any other haemostatic agent in the management of patients with epistaxis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register (via CRS Web); Central Register of Controlled Trials (CENTRAL) (via CRS Web); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 29 October 2018.\nSelection criteria\nRandomised controlled trials (RCTs) of tranexamic acid (in addition to usual care) compared with usual care plus placebo, usual care alone or usual care plus any other haemostatic agent, to control epistaxis in adults or children.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcomes were control of epistaxis: re-bleeding (as measured by the proportion of patients re-bleeding within a period of up to 10 days) and significant adverse effects (seizures, thromboembolic events). Secondary outcomes were control of epistaxis as measured by the time to stop initial bleeding (the proportion of patients whose bleeding is controlled within a period of up to 30 minutes); severity of re-bleeding (as measured by (a) the proportion of patients requiring any further intervention and (b) the proportion of patients requiring blood transfusion); length of hospital stay and other adverse effects. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included six RCTs (692 participants). The overall risk of bias in the studies was low. Two studies assessed oral administration of tranexamic acid, given regularly over several days, and compared it to placebo. In the other four studies, a single application of topical tranexamic acid was compared with placebo (one study) and a combination of epinephrine and lidocaine or phenylephrine (three studies). All participants were adults.\nTranexamic acid versus placebo\nFor our primary outcome, control of epistaxis: re-bleeding (proportion re-bleeding within 10 days), we were able to pool data from three studies. The pooled result demonstrated a benefit of tranexamic acid compared to placebo, the risk of re-bleeding reducing from 67% to 47% (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; three studies; 225 participants; moderate-quality evidence).\nWhen we compared the effects of oral and topical tranexamic acid separately the risk of re-bleeding with oral tranexamic acid reduced from 69% to 49%, RR 0.73 (95% CI 0.55 to 0.96; two studies, 157 participants; moderate-quality evidence) and with topical tranexamic acid it reduced from 66% to 43%, RR 0.66 (95% CI 0.41 to 1.05; single study, 68 participants). We rated the quality of evidence provided by the single study as low, therefore it is uncertain whether topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application.\nNo study specifically sought to identify and report our primary outcome: significant adverse effects (i.e. seizures, thromboembolic events).\nThe secondary outcome time to stop initial bleeding (proportion with bleeding controlled within 30 minutes) was measured in one study using topical tranexamic acid and there was no evidence of a difference at 30 minutes (RR 0.79, 95% CI 0.56 to 1.11; 68 participants; low-quality evidence).\nNo studies reported the proportion of patients requiring any further intervention (e.g. repacking, surgery, embolisation).\nOne study of oral tranexamic acid reported the proportion of patients requiring blood transfusion and found no difference between groups: 5/45 (11%) versus 6/44 (14%) (RR 0.81, 95% CI 0.27 to 2.48; 89 participants; low-quality evidence).\nTwo studies reported hospital length of stay. One study reported a significantly shorter stay in the oral tranexamic acid group (mean difference (MD) -1.60 days, 95% CI -2.49 to -0.71; 68 participants). The other study found no evidence of a difference between the groups.\nTranexamic acid versus other haemostatic agents\nWhen we pooled the data from three studies the proportion of patients whose bleeding stopped within 10 minutes was significantly higher in the topical tranexamic acid group compared to the group receiving another haemostatic agent (70% versus 30%: RR 2.35, 95% CI 1.90 to 2.92; 460 participants) (moderate-quality evidence).\nAdverse effects across all studies\nFive studies recorded 'adverse effects' in a general way. None found any difference between the groups in the occurrence of minor adverse effects (e.g. mild nausea and diarrhoea, 'bad taste' of gel). In one study a patient developed a superficial thrombophlebitis of both legs following discharge, however it is not reported in which group this occurred. No \"other serious adverse effect\" was reported in any study.\nAuthors' conclusions\nWe found moderate-quality evidence that there is probably a reduction in the risk of re-bleeding with the use of either oral or topical tranexamic acid in addition to usual care in adult patients with epistaxis, compared to placebo with usual care. However, the quality of evidence relating solely to topical tranexamic acid was low (one study only), so we are uncertain whether or not topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application. We found moderate-quality evidence that topical tranexamic acid is probably better than other topical agents in stopping bleeding in the first 10 minutes.\nThere have been only three RCTs on this subject since 1995. Since then there have been significant changes in nasal cauterisation and packing techniques (for example, techniques including nasal endoscopy and more invasive approaches such as endoscopic sphenopalatine artery ligation). New trials would inform us about the effectiveness of tranexamic acid in light of these developments.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies measured re-bleeding within 10 days. When we combined the results we found that fewer patients who were given either oral or topical tranexamic acid had further episodes of re-bleeding following an initial nosebleed compared to those treated with usual care.\nThe time to stop initial bleeding (control of bleeding within 30 minutes) was measured in four studies. In three studies the proportion of patients whose bleeding stopped within 10 minutes was significantly higher in the group receiving topical tranexamic acid compared to the group receiving a different drug (topical epinephrine and lidocaine or phenylephrine). In the other study there was no significant difference at 30 minutes when topical tranexamic acid was compared with placebo.\nNo studies reported the proportion of patients requiring any further intervention (e.g. repacking, surgery).\nOnly one study of oral tranexamic acid reported the proportion of patients requiring a blood transfusion and there was no evidence of a difference between the groups.\nLength of hospital stay was reported in two studies. One study reported a significantly shorter stay in the oral tranexamic acid group, while the other found no evidence of a difference.\nFive studies mention recording \"adverse effects\". None found any difference between the groups in the occurrence of minor adverse effects (e.g. mild nausea and diarrhoea, 'bad taste' of gel). In one study a patient did develop a superficial thrombophlebitis (inflammation and a blood clot in a vein near the surface of the skin) of both legs following discharge, but the study did not report in which treatment group this happened. No serious adverse event was seen in any of the studies."
}
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query-laysum | 5315 | [
{
"role": "user",
"content": "Abstract: Background\nCryptococcal disease remains one of the main causes of death in HIV-positive people who have low cluster of differentiation 4 (CD4) cell counts. Currently, the World Health Organization (WHO) recommends screening HIV-positive people with low CD4 counts for cryptococcal antigenaemia (CrAg), and treating those who are CrAg-positive. This Cochrane Review examined the effects of an approach where those with low CD4 counts received regular prophylactic antifungals, such as fluconazole.\nObjectives\nTo assess the efficacy and safety of antifungal drugs for the primary prevention of cryptococcal disease in adults and children who are HIV-positive.\nSearch methods\nWe searched the CENTRAL, MEDLINE PubMed, Embase OVID, CINAHL EBSCOHost, WHO International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, conference proceedings for the International AIDS Society (IAS) and Conference on Retroviruses and Opportunistic Infections (CROI), and reference lists of relevant articles up to 31 August 2017.\nSelection criteria\nRandomized controlled trials of adults and children, who are HIV-positive with low CD4 counts, without a current or prior diagnosis of cryptococcal disease that compared any antifungal drug taken as primary prophylaxis to placebo or standard care.\nData collection and analysis\nTwo review authors independently assessed eligibility and risk of bias, and extracted and analysed data. The primary outcome was all-cause mortality. We summarized all outcomes using risk ratios (RR) with 95% confidence intervals (CI). Where appropriate, we pooled data in meta-analyses. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nNine trials, enrolling 5426 participants, met the inclusion criteria of this review. Six trials administered fluconazole, while three trials administered itraconazole.\nAntifungal prophylaxis may make little or no difference to all-cause mortality (RR 1.07, 95% CI 0.80 to 1.43; 6 trials, 3220 participants; low-certainty evidence). For cryptococcal specific outcomes, prophylaxis probably reduces the risk of developing cryptococcal disease (RR 0.29, 95% CI 0.17 to 0.49; 7 trials, 5000 participants; moderate-certainty evidence), and probably reduces deaths due to cryptococcal disease (RR 0.29, 95% CI 0.11 to 0.72; 5 trials, 3813 participants; moderate-certainty evidence). Fluconazole prophylaxis may make no clear difference to the risk of developing clinically resistant Candida disease (RR 0.93, 95% CI 0.56 to 1.56; 3 trials, 1198 participants; low-certainty evidence); however, there may be an increased detection of fluconazole-resistant Candida isolates from surveillance cultures (RR 1.25, 95% CI 1.00 to 1.55; 3 trials, 539 participants; low-certainty evidence). Antifungal prophylaxis was generally well-tolerated with probably no clear difference in the risk of discontinuation of antifungal prophylaxis compared with placebo (RR 1.01, 95% CI 0.91 to 1.13; 4 trials, 2317 participants; moderate-certainty evidence). Antifungal prophylaxis may also make no difference to the risk of having any adverse event (RR 1.07, 95% CI 0.88 to 1.30; 4 trials, 2317 participants; low-certainty evidence), or a serious adverse event (RR 1.08, 95% CI 0.83 to 1.41; 4 trials, 888 participants; low-certainty evidence) when compared to placebo or standard care.\nAuthors' conclusions\nAntifungal prophylaxis reduced the risk of developing and dying from cryptococcal disease. Therefore, where CrAG screening is not available, antifungal prophylaxis may be used in patients with low CD4 counts at diagnosis and who are at risk of developing cryptococcal disease.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out if taking an antifungal drug regularly, such as fluconazole, prevented HIV-positive people who have low cluster of differentiation 4 (CD4) cell counts, from getting cryptococcal disease, and what the potential complications were. Cochrane researchers collected and analysed all relevant studies to answer this question, and found nine trials that looked at this question."
}
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query-laysum | 5316 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is the commonest inherited life-shortening illness in white populations, caused by a mutation in the gene that codes for the cystic fibrosis transmembrane regulator protein (CFTR), which functions as a salt transporter. This mutation mainly affects the airways where excess salt absorption dehydrates the airway lining leading to impaired mucociliary clearance. Consequently, thick, sticky mucus accumulates making the airway prone to chronic infection and progressive inflammation; respiratory failure often ensues. Other complications include malnutrition, diabetes and subfertility.\nIncreased understanding of the condition has allowed pharmaceutical companies to design mutation-specific therapies targeting the underlying molecular defect. CFTR potentiators target mutation classes III and IV and aim to normalise airway surface liquid and mucociliary clearance, which in turn impacts on the chronic infection and inflammation. This is an update of a previously published review.\nObjectives\nTo evaluate the effects of CFTR potentiators on clinically important outcomes in children and adults with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles, reviews and online clinical trial registries. Last search: 21 November 2018.\nSelection criteria\nRandomised controlled trials (RCTs) of parallel design comparing CFTR potentiators to placebo in people with CF. A separate review examines trials combining CFTR potentiators with other mutation-specific therapies.\nData collection and analysis\nThe authors independently extracted data, assessed the risk of bias in included trials and used GRADE to assess evidence quality. Trial authors were contacted for additional data.\nMain results\nWe included five RCTs (447 participants with different mutations) lasting from 28 days to 48 weeks, all assessing the CFTR potentiator ivacaftor. The quality of the evidence was moderate to low, mainly due to risk of bias (incomplete outcome data and selective reporting) and imprecision of results, particularly where few individuals experienced adverse events. Trial design was generally well-documented. All trials were industry-sponsored and supported by other non-pharmaceutical funding bodies.\nF508del (class II) (140 participants)\nOne 16-week trial reported no deaths, or changes in quality of life (QoL) or lung function (either relative or absolute change in forced expiratory volume in one second (FEV1) (moderate-quality evidence). Pulmonary exacerbations and cough were the most reported adverse events in ivacaftor and placebo groups, but there was no difference between groups (low-quality evidence); there was also no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Number of days until the first exacerbation was not reported, but there was no difference between groups in how many participants developed pulmonary exacerbations. There was also no difference in weight. Sweat chloride concentration decreased, mean difference (MD) -2.90 mmol/L (95% confidence interval (CI) -5.60 to -0.20).\nG551D (class III) (238 participants)\nThe 28-day phase 2 trial (19 participants) and two 48-week phase 3 trials (adult trial (167 adults), paediatric trial (52 children)) reported no deaths. QoL scores (respiratory domain) were higher with ivacaftor in the adult trial at 24 weeks, MD 8.10 (95% CI 4.77 to 11.43) and 48 weeks, MD 8.60 (95% CI 5.27 to 11.93 (moderate-quality evidence). The adult trial reported a higher relative change in FEV1 with ivacaftor at 24 weeks, MD 16.90% (95% CI 13.60 to 20.20) and 48 weeks, MD 16.80% (95% CI 13.50 to 20.10); the paediatric trial reported this at 24 weeks, MD 17.4% (P < 0.0001)) (moderate-quality evidence). These trials demonstrated absolute improvements in FEV1 (% predicted) at 24 weeks, MD 10.80% (95% CI 8.91 to 12.69) and 48 weeks, MD 10.44% (95% CI 8.56 to 12.32). The phase 3 trials reported increased cough, odds ratio (OR) 0.57 (95% CI 0.33 to 1.00) and episodes of decreased pulmonary function, OR 0.29 (95% CI 0.10 to 0.82) in the placebo group; ivacaftor led to increased dizziness in adults, OR 10.55 (95% CI 1.32 to 84.47). There was no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Fewer participants taking ivacaftor developed serious pulmonary exacerbations; adults taking ivacaftor developed fewer exacerbations (serious or not), OR 0.54 (95% CI 0.29 to 1.01). A higher proportion of participants were exacerbation-free at 24 weeks with ivacaftor (moderate-quality evidence). Ivacaftor led to a greater absolute change from baseline in FEV1 (% predicted) at 24 weeks, MD 10.80% (95% CI 8.91 to 12.69) and 48 weeks, MD 10.44% (95% CI 8.56 to 12.32); weight also increased at 24 weeks, MD 2.37 kg (95% CI 1.68 to 3.06) and 48 weeks, MD 2.75 kg (95% CI 1.74 to 3.75). Sweat chloride concentration decreased at 24 weeks, MD -48.98 mmol/L (95% CI -52.07 to -45.89) and 48 weeks, MD -49.03 mmol/L (95% CI -52.11 to -45.94).\nR117H (class IV) (69 participants)\nOne 24-week trial reported no deaths. QoL scores (respiratory domain) were higher with ivacaftor at 24 weeks, MD 8.40 (95% CI 2.17 to 14.63), but no relative changes in lung function were reported (moderate-quality evidence). Pulmonary exacerbations and cough were the most reported adverse events in both groups, but there was no difference between groups; there was no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Number of days until the first exacerbation was not reported, but there was no difference between groups in how many participants developed pulmonary exacerbations. No changes in absolute change in FEV1 or weight were reported. Sweat chloride concentration decreased, MD -24.00 mmol/L (CI 95% -24.69 to -23.31).\nAuthors' conclusions\nThere is no evidence supporting the use of ivacaftor in people with the F508del mutation. Both G551D phase 3 trials demonstrated a clinically relevant impact of ivacaftor on outcomes at 24 and 48 weeks in adults and children (over six years of age) with CF. The R117H trial demonstrated an improvement in the respiratory QoL score, but no improvement in respiratory function.\nAs new mutation-specific therapies emerge, it is important that trials examine outcomes relevant to people with CF and their families and that adverse events are reported robustly and consistently. Post-market surveillance is essential and ongoing health economic evaluations are required.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "How does ivacaftor affect clinical outcomes (survival, quality of life and lung function) in people with cystic fibrosis (CF)?"
}
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query-laysum | 5317 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal hyperbilirubinaemia is a common problem which carries a risk of neurotoxicity. Certain infants who have hyperbilirubinaemia develop bilirubin encephalopathy and kernicterus which may lead to long-term disability. Phototherapy is currently the mainstay of treatment for neonatal hyperbilirubinaemia. Among the adjunctive measures to compliment the effects of phototherapy, fluid supplementation has been proposed to reduce serum bilirubin levels. The mechanism of action proposed includes direct dilutional effects of intravenous (IV) fluids, or enhancement of peristalsis to reduce enterohepatic circulation by oral fluid supplementation.\nObjectives\nTo assess the risks and benefits of fluid supplementation compared to standard fluid management in term and preterm newborn infants with unconjugated hyperbilirubinaemia who require phototherapy.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 5), MEDLINE via PubMed (1966 to 7 June 2017), Embase (1980 to 7 June 2017), and CINAHL (1982 to 7 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised controlled trials that compared fluid supplementation against no fluid supplementation, or one form of fluid supplementation against another.\nData collection and analysis\nWe extracted data using the standard methods of the Cochrane Neonatal Review Group using the Covidence platform. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using mean difference (MD), risk difference (RD), and risk ratio (RR) with 95% confidence intervals (CIs).\nMain results\nOut of 1449 articles screened, seven studies were included. Three articles were awaiting classification, among them, two completed trials identified from the trial registry appeared to be unpublished so far.\nThere were two major comparisons: IV fluid supplementation versus no fluid supplementation (six studies) and IV fluid supplementation versus oral fluid supplementation (one study). A total of 494 term, healthy newborn infants with unconjugated hyperbilirubinaemia were evaluated. All studies were at high risk of bias for blinding of care personnel, five studies had unclear risk of bias for blinding of outcome assessors, and most studies had unclear risk of bias in allocation concealment. There was low- to moderate-quality evidence for all major outcomes.\nIn the comparison between IV fluid supplementation and no supplementation, no infant in either group developed bilirubin encephalopathy in the one study that reported this outcome. Serum bilirubin was lower at four hours postintervention for infants who received IV fluid supplementation (MD -34.00 μmol/L (-1.99 mg/dL), 95% CI -52.29 (3.06) to -15.71 (0.92); participants = 67, study = 1) (low quality of evidence, downgraded one level for indirectness and one level for suspected publication bias). Beyond eight hours postintervention, serum bilirubin was similar between the two groups. Duration of phototherapy was significantly shorter for fluid-supplemented infants, but the estimate was affected by heterogeneity which was not clearly explained (MD -10.70 hours, 95% CI -15.55 to -5.85; participants = 218; studies = 3; I² = 67%). Fluid-supplemented infants were less likely to require exchange transfusion (RR 0.39, 95% CI 0.21 to 0.71; RD -0.01, 95% CI -0.04 to 0.02; participants = 462; studies = 6; I² = 72%) (low quality of evidence, downgraded one level due to inconsistency, and another level due to suspected publication bias), and the estimate was similarly affected by unexplained heterogeneity. The frequencies of breastfeeding were similar between the fluid-supplemented and non-supplemented infants in days one to three based on one study (estimate on day three: MD 0.90 feeds, 95% CI -0.40 to 2.20; participants = 60) (moderate quality of evidence, downgraded one level for imprecision).\nOne study contributed to all outcome data in the comparison of IV versus oral fluid supplementation. In this comparison, no infant in either group developed abnormal neurological signs. Serum bilirubin, as well as the rate of change of serum bilirubin, were similar between the two groups at four hours after phototherapy (serum bilirubin: MD 11.00 μmol/L (0.64 mg/dL), 95% CI -21.58 (-1.26) to 43.58 (2.55); rate of change of serum bilirubin: MD 0.80 μmol/L/hour (0.05 mg/dL/hour), 95% CI -2.55 (-0.15) to 4.15 (0.24); participants = 54 in both outcomes) (moderate quality of evidence for both outcomes, downgraded one level for indirectness). The number of infants who required exchange transfusion was similar between the two groups (RR 1.60, 95% CI 0.60 to 4.27; RD 0.11, 95% CI -0.12 to 0.34; participants = 54). No infant in either group developed adverse effects including vomiting or abdominal distension.\nAuthors' conclusions\nThere is no evidence that IV fluid supplementation affects important clinical outcomes such as bilirubin encephalopathy, kernicterus, or cerebral palsy in healthy, term newborn infants with unconjugated hyperbilirubinaemia requiring phototherapy. In this review, no infant developed these bilirubin-associated clinical complications. Low- to moderate-quality evidence shows that there are differences in total serum bilirubin levels between fluid-supplemented and control groups at some time points but not at others, the clinical significance of which is uncertain. There is no evidence of a difference between the effectiveness of IV and oral fluid supplementations in reducing serum bilirubin. Similarly, no infant developed adverse events or complications from fluid supplementation such as vomiting or abdominal distension. This suggests a need for future research to focus on different population groups with possibly higher baseline risks of bilirubin-related neurological complications, such as preterm or low birthweight infants, infants with haemolytic hyperbilirubinaemia, as well as infants with dehydration for comparison of different fluid supplementation regimen.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we searched medical databases in February 2016."
}
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query-laysum | 5318 | [
{
"role": "user",
"content": "Abstract: Background\nA number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT.\nObjectives\nTo evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances.\nSearch methods\nWe searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to January 2014, and contacted the main authors in the subject area. There was no language restriction in the search.\nSelection criteria\nWe planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment).\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%.\nMain results\nWe included 11 randomised controlled studies with 735 participants which produced 16 meta-analyses of outcome data. Meta-analysis indicated that the primary outcome of intervention failure, occurred in lower proportion of participants with PEG compared to NGT (RR 0.18, 95% CI 0.05 to 0.59, eight studies, 408 participants, low quality evidence) and this difference was statistically significant. For this outcome, we also subgrouped the studies by endoscopic gastrostomy technique into pull, and push and not reported. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, 90 participants). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, one study, 33 participants) techniques. We found no statistically significant difference in cases where the technique was not reported (RR 0.43, 95% CI 0.13 to 1.44, four studies, 285 participants).\nThere was no statistically significant difference between the groups for meta-analyses of the secondary outcomes of mortality (RR 0.86, 95% CI 0.58 to 1.28, 644 participants, nine studies, very low quality evidence), overall reports of any adverse event at any follow-up time point (ITT analysis, RR 0.83, 95% CI 0.51 to 1.34), 597 participants, 6 studies, moderate quality evidence), specific adverse events including pneumonia (aspiration) (RR 0.70, 95% CI 0.46 to 1.06, 645 participants, seven studies, low quality evidence), or for the meta- analyses of the secondary outcome of nutritional status including weight change from baseline, and mid-arm circumference at endpoint, although there was evidence in favour of PEG for meta-analyses of mid-arm circumference change from baseline (MD 1.16, 95% CI 1.01 to 1.31, 115 participants, two studies), and levels of serum albumin were higher in the PEG group (MD 6.03, 95% CI 2.31 to 9.74, 107 participants).\nFor meta-analyses of the secondary outcomes of time on enteral nutrition, there was no statistically significant difference (MD 14.48, 95% CI -2.74 to 31.71; 119 participants, two studies). For meta-analyses of quality of life measures (EuroQol) outcomes in two studies with 133 participants, for inconvenience (RR 0.03, 95% CI 0.00 to 0.29), discomfort (RR 0.03, 95% CI 0.00 to 0.29), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001) and social activities (RR 0.01, 95% CI 0.00 to 0.18) the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with social activities. However, there were no significant differences between the groups for pain, ease of learning to use, or the secondary outcome of length of hospital stay (two studies, 381 participants).\nAuthors' conclusions\nPEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration. Future studies should include details of participant demographics including underlying disease, age and gender, and the gastrostomy technique.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The studies showed a higher probability of treatment failure with a nasal gastric tube. The number of deaths was no different with the two methods; nor was the overall occurrence of adverse events. Participants with PEGs may have a better quality of life."
}
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query-laysum | 5319 | [
{
"role": "user",
"content": "Abstract: Background\nRecurrence of atrial tachyarrhythmias (ATa) following catheter ablation for atrial fibrillation (AF) is a common problem. Antiarrhythmic drugs have been used shortly after ablation in an attempt to maintain sinus rhythm, particularly Class I and III agents. However, it still needs to be established if the use of Class I or III antiarrhythmic medications, or both, reduce the risk of recurrence of ATa.\nObjectives\nTo assess the effects of oral Class I and III antiarrhythmic drugs versus control (standard medical therapy without Class I or III antiarrhythmics, or placebo) for maintaining sinus rhythm in people undergoing catheter ablation for AF.\nSearch methods\nWe systematically searched CENTRAL, MEDLINE, Embase, Web of Science Core Collection, and two clinical trial registers without restrictions on language or date to 5 August 2022.\nSelection criteria\nWe sought published, unpublished, and ongoing parallel-design, randomised controlled trials (RCTs) involving adult participants undergoing ablation for AF, with subsequent comparison of Class I and/or III antiarrhythmic use versus control (standard medical therapy or non-Class I and/or III antiarrhythmic use).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and performed meta-analyses with risk ratios (RR) and Peto odds ratios (Peto OR). Our primary outcomes were recurrence of atrial tachyarrhythmias; adverse events: thromboembolic events; adverse events: myocardial infarction; adverse events: new diagnosis of heart failure; and adverse events: requirement for one or more hospitalisations for atrial tachyarrhythmia. Our secondary outcomes were: all-cause mortality; and requirement for one or more repeat ablations. Where possible, we performed comparison analysis by Class I and/or III antiarrhythmic and divided follow-up periods for our primary outcome. We performed comprehensive assessments of risk of bias and certainty of evidence applying the GRADE methodology.\nMain results\nWe included nine RCTs involving a total of 3269 participants. Participants were on average 59.3 years old; 71.0% were male; and 72.9% and 27.4% had paroxysmal and persistent AF, respectively. Class I and/or III antiarrhythmics may reduce recurrence of ATa at 0 to 3 months postablation (risk ratio (RR) 0.74, 95% confidence interval (CI) 0.59 to 0.94, 8 trials, 3046 participants, low-certainty evidence) and likely reduce recurrence at > 3 to 6 months, our a priori primary time point (RR 0.85, 95% CI 0.78 to 0.93, 5 trials, 2591 participants, moderate-certainty evidence). Beyond six months the evidence is very uncertain, and the benefit of antiarrhythmics may not persist (RR 1.14, 95% CI 0.84 to 1.55, 4 trials, 2244 participants, very low-certainty evidence). The evidence suggests that Class I and/or III antiarrhythmics may not increase the risk of thromboembolic events, myocardial infarction, all-cause mortality, or requirement for repeat ablation, at 0 to 3, > 3 to 6, and > 6 months (where data were available; low- to very low-certainty evidence). The use of Class I and/or III antiarrhythmics postablation likely reduces hospitalisations for ATa by approximately 57% at 0 to 3 months (RR 0.43, 95% CI 0.28 to 0.64, moderate-certainty evidence). No data were available beyond three months. No data were available on new diagnoses of heart failure.\nFewer data were available for Class I and III antiarrhythmics individually. Based on only one and two trials (n = 125 to 309), Class I antiarrhythmics may have little effect on recurrence of ATa at 0 to 3, > 3 to 6, and > 6 months (RR 0.88, 95% CI 0.64 to 1.20, 2 trials, 309 participants; RR 0.54, 95% CI 0.25 to 1.19, 1 trial, 125 participants; RR 0.87, 95% CI 0.57 to 1.32, 1 trial, 125 participants; low-certainty evidence throughout); requirement for hospitalisation for ATa at 0 to 3 months (low-certainty evidence); or requirement for repeat ablation at 0 to 3 months (low-certainty evidence). No data were available for thromboembolic events, myocardial infarction, new diagnosis of heart failure, or all-cause mortality at any time points, or hospitalisation or repeat ablation beyond three months.\nClass III antiarrhythmics may have little effect on recurrence of ATa at up to 3 months and at > 3 to 6 months (RR 0.76, 95% CI 0.50 to 1.16, 4 trials, 599 participants, low-certainty evidence; RR 0.82, 95% CI 0.62 to 1.09, 2 trials, 318 participants, low-certainty evidence), and beyond 6 months one trial reported a possible increase in recurrence of ATa (RR 1.95, 95% CI 1.29 to 2.94, 1 trial, 112 participants, low-certainty evidence). Class III antiarrhythmics likely reduce hospitalisations for ATa at 0 to 3 months (RR 0.40, 95% CI 0.26 to 0.63, moderate-certainty evidence), and may have little effect on all-cause mortality (low- to very low-certainty evidence). The effect of Class III antiarrhythmics on thromboembolic events and requirement for repeat ablation was uncertain (very low-certainty evidence for both outcomes). No data were available for myocardial infarction or new diagnosis of heart failure at any time point, outcomes other than recurrence beyond 6 months, or for hospitalisation and repeat ablation > 3 to 6 months.\nWe assessed the majority of included trials as at low or unclear risk of bias. One trial reported an error in the randomisation process, raising the potential risk of selection bias; most of the included trials were non-blinded; and two trials were at high risk of attrition bias.\nAuthors' conclusions\nWe found evidence to suggest that the use of Class I and/or III antiarrhythmics up to 3 months after ablation is associated with a reduced recurrence of ATa 0 to 6 months after ablation, which may not persist beyond 6 months, and an immediate reduction in hospitalisation for ATa 0 to 3 months after ablation. The evidence suggests there is no difference in rates of all-cause mortality, thromboembolic events, or myocardial infarction between Class I and/or III antiarrhythmics versus control.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that the effect of Class I and/or III antiarrhythmic drugs given up to around 3 months after ablation may reduce recurrence of arrhythmia at 0 to 3 months, and likely reduces recurrence at greater than 3 to 6 months, although the benefit does not appear to continue beyond 6 months (the evidence for this last result was very uncertain). We also looked at adverse outcomes (i.e. complications). We found that the use of antiarrhythmics was probably associated with a reduction in hospitalisation at 0 to 3 months. We also found evidence suggesting that antiarrhythmics are not associated with different rates of thromboembolic events (clots in the brain, lungs, or legs), heart attacks, death due to any cause, or requirement for repeat ablation compared with control or standard treatment."
}
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query-laysum | 5320 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is a psychiatric diagnosis increasingly used in adults. The recommended first-line pharmacological treatment is central nervous system (CNS) stimulants, such as methylphenidate, but uncertainty remains about its benefits and harms.\nObjectives\nTo assess the beneficial and harmful effects of extended-release formulations of methylphenidate in adults diagnosed with ADHD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, nine other databases and four clinical trial registries up to February 2021. We searched 12 drug regulatory databases for clinical trial data up to 13 May 2020. In addition, we cross-referenced all available trial identifiers, handsearched reference lists, searched pharmaceutical company databases, and contacted trial authors.\nSelection criteria\nRandomised, double-blind, parallel-group trials comparing extended-release methylphenidate formulations at any dose versus placebo and other ADHD medications in adults diagnosed with ADHD.\nData collection and analysis\nTwo review authors independently extracted data. We assessed dichotomous outcomes as risk ratios (RRs), and rating scales and continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs). We used the Cochrane risk of bias tool to assess risks of bias, and GRADE to assess the certainty of the evidence. We meta-analysed the data using a random-effects model. We assessed three design characteristics that may impair the trial results' 'generalisability'; exclusion of participants with psychiatric comorbidity; responder selection based on previous experience with CNS stimulants; and risk of withdrawal effects. Our prespecified primary outcomes were functional outcomes, self-rated ADHD symptoms, and serious adverse events. Our secondary outcomes included quality of life, ADHD symptoms rated by investigators and by peers such as family members, cardiovascular variables, severe psychiatric adverse events, and other adverse events.\nMain results\nWe included 24 trials (5066 participants), of which 21 reported outcome data for this review. We also identified one ongoing study. We included documents from six drug regulatory agencies covering eight trials. Twenty-one trials had an outpatient setting and three were conducted in prisons. They were primarily conducted in North America and Europe. The median participant age was 36 years. Twelve trials (76% of participants) were industry-sponsored, four (14% of participants) were publicly funded with industry involvement, seven (10% of participants) were publicly funded, and one had unclear funding. The median trial duration was eight weeks. One trial was rated at overall unclear risk of bias and 20 trials were rated at overall high risk of bias, primarily due to unclear blinding of participants and investigators, attrition bias, and selective outcome reporting. All trials were impaired in at least one of the three design characteristics related to 'generalisability'; for example, they excluded participants with psychiatric comorbidity such as depression or anxiety, or included participants only with a previous positive response to methylphenidate, or similar drugs. This may limit the trials’ usefulness for clinical practice, as they may overestimate the benefits and underestimate the harms.\nExtended-release methylphenidate versus placebo (up to 26 weeks)\nFor the primary outcomes, we found very low-certainty evidence that methylphenidate had no effect on ‘days missed at work’ at 13-week follow-up (mean difference (MD) −0.15 days, 95% confidence interval (CI) −2.11 to 1.81; 1 trial, 409 participants) or serious adverse events (risk ratio (RR) 1.43, CI 95% CI 0.85 to 2.43; 14 trials, 4078 participants), whereas methylphenidate improved self-rated ADHD symptoms (small-to-moderate effect; SMD −0.37, 95% CI −0.43 to −0.30; 16 trials, 3799 participants). For secondary outcomes, we found very low-certainty evidence that methylphenidate improved self-rated quality of life (small effect; SMD −0.15, 95% CI −0.25 to −0.05; 6 trials, 1888 participants), investigator-rated ADHD symptoms (small-to-moderate effect; SMD −0.42, 95% CI −0.49 to −0.36; 18 trials, 4183 participants), ADHD symptoms rated by peers such as family members (small-to-moderate effect; SMD −0.31, 95% CI −0.48 to −0.14; 3 trials, 1005 participants), and increased the risk of experiencing any adverse event (RR 1.27, 95% CI 1.19 to 1.37; 14 trials, 4214 participants). We rated the certainty of the evidence as ‘very low’ for all outcomes, primarily due to high risk of bias and 'indirectness of the evidence'. One trial (419 participants) had follow-up at 52 weeks and two trials (314 participants) included active comparators, hence long-term and comparative evidence is limited.\nAuthors' conclusions\nWe found very low-certainty evidence that extended-release methylphenidate compared to placebo improved ADHD symptoms (small-to-moderate effects) measured on rating scales reported by participants, investigators, and peers such as family members. Methylphenidate had no effect on 'days missed at work' or serious adverse events, the effect on quality of life was small, and it increased the risk of several adverse effects. We rated the certainty of the evidence as ‘very low’ for all outcomes, due to high risk of bias, short trial durations, and limitations to the generalisability of the results. The benefits and harms of extended-release methylphenidate therefore remain uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review investigated the positive and negative effects of methylphenidate and compared them to placebo or to other medications in adults diagnosed with attention deficit hyperactivity disorder (ADHD). We particularly focused on effects on daily functioning, such as the number of days a person is absent from work, and the effects on ADHD symptoms and quality of life assessed by the patients themselves, and also by a doctor or a researcher."
}
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query-laysum | 5321 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately one-third of individuals with interstitial lung disease (ILD) have associated connective tissue disease (CTD). The connective tissue disorders most commonly associated with ILD include scleroderma/systemic sclerosis (SSc), rheumatoid arthritis, polymyositis/dermatomyositis, and Sjögren's syndrome. Although many people with CTD-ILD do not develop progressive lung disease, a significant proportion do progress, leading to reduced physical function, decreased quality of life, and death. ILD is now the major cause of death amongst individuals with systemic sclerosis.\nCyclophosphamide is a highly potent immunosuppressant that has demonstrated efficacy in inducing and maintaining remission in autoimmune and inflammatory illnesses. However this comes with potential toxicities, including nausea, haemorrhagic cystitis, bladder cancer, bone marrow suppression, increased risk of opportunistic infections, and haematological and solid organ malignancies.\nDecision-making in the treatment of individuals with CTD-ILD is difficult; the clinician needs to identify those who will develop progressive disease, and to weigh up the balance between a high level of need for therapy in a severely unwell patient population against the potential for adverse effects from highly toxic therapy, for which only relatively limited data on efficacy can be found. Similarly, it is not clear whether histological subtype, disease duration, or disease extent can be used to predict treatment responsiveness.\nObjectives\nTo assess the efficacy and adverse effects of cyclophosphamide in the treatment of individuals with CTD-ILD.\nSearch methods\nWe performed searches on CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science up to May 2017. We handsearched review articles, clinical trial registries, and reference lists of retrieved articles.\nSelection criteria\nWe included randomised controlled parallel-group trials that compared cyclophosphamide in any form, used individually or concomitantly with other immunomodulating therapies, versus non-cyclophosphamide-containing therapies for at least six months, with follow-up of at least 12 months from the start of treatment.\nData collection and analysis\nWe imported studies identified by the search into a reference manager database. We retrieved the full-text versions of relevant studies, and two review authors independently extracted data. Primary outcomes were change in lung function (change in forced vital capacity (FVC) % predicted and diffusing capacity of the lung for carbon monoxide (DLCO) % predicted), adverse events, and health-related quality of life measures. Secondary outcomes included all-cause mortality, dyspnoea, cough, and functional exercise testing. When appropriate, we performed meta-analyses and subgroup analyses by severity of lung function, connective tissue disease diagnosis, and radiological pattern of fibrosis. We assessed the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and created 'Summary of findings' tables.\nMain results\nWe included in the analysis four trials with 495 participants (most with systemic sclerosis). We formed two separate comparisons: cyclophosphamide versus placebo (two trials, 195 participants) and cyclophosphamide versus mycophenolate (two trials, 300 participants). We found evidence to be of low quality, as dropout rates were high in the intervention groups, and as we noted a wide confidence interval around the effect with small differences, which affected the precision of results.\nThe data demonstrates significant improvement in lung function with cyclophosphamide compared with placebo (post-treatment FVC % mean difference (MD) 2.83, 95% confidence interval (CI) 0.80 to 4.87; P = 0.006) but no significant difference in post-treatment DLCO (% MD -1.68, 95% CI -4.37 to 1.02; P = 0.22; two trials, 182 participants).\nRisk of adverse effects was increased in the cyclophosphamide treatment groups compared with the placebo groups, in particular, haematuria, leukopenia, and nausea, leading to a higher rate of withdrawal from cyclophosphamide treatment. The data demonstrates statistically significant improvement in one-measure of quality of life in one trial favouring cyclophosphamide over placebo and clinically and statistically significant improvement in breathlessness in one trial favouring cyclophosphamide compared with placebo, with no significant impact on mortality.\nTrialists reported no significant impact on lung function when cyclophosphamide was used compared with mycophenolate at 12 months (FVC % MD -0.82, 95% CI -3.95 to 2.31; P = 0.61; two trials, 149 participants; DLCO % MD -1.41, 95% CI -10.40 to 7.58; P = 0.76; two trials, 149 participants).\nRisk of side effects was increased with cyclophosphamide versus mycophenolate, in particular, leukopenia and thrombocytopenia.\nThe data demonstrates no significant impact on health-related quality of life, all-cause mortality, dyspnoea, or cough severity in the cyclophosphamide group compared with the mycophenolate group. No trials reported outcomes associated with functional exercise tests.\nWe performed subgroup analysis to determine whether severity of lung function, connective tissue disease diagnosis, or radiological pattern had any impact on outcomes. One trial reported that cyclophosphamide protected against decreased FVC in individuals with worse fibrosis scores, and also showed that cyclophosphamide may be more effective in those with worse lung function. No association could be made between connective tissue disease diagnosis and outcomes.\nAuthors' conclusions\nThis review, which is based on studies of varying methodological quality, demonstrates that overall, in this population, small benefit may be derived from the use of cyclophosphamide in terms of mean difference in % FVC when compared with placebo, but not of the difference in % DLCO, or when compared with mycophenolate. Modest clinical improvement in dyspnoea may be noted with the use of cyclophosphamide. Clinical practice guidelines should advise clinicians to consider individual patient characteristics and to expect only modest benefit at best in preserving FVC. Clinicians should carefully monitor for adverse effects during treatment and in the years thereafter.\nFurther studies are required to examine the use of cyclophosphamide; they should be adequately powered to compare outcomes within different subgroups, specifically, stratified for extent of pulmonary infiltrates on high-resolution computed tomography (HRCT) and skin involvement in SSc. Studies on other forms of connective tissue disease are needed. Researchers may consider comparing cyclophosphamide (a potent immunosuppressant) versus antifibrotic agents, or comparing both versus placebo, in particular, for those with evidence of rapidly progressive fibrotic disease, who may benefit the most.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the quality of the evidence using one of the following grades: very low, low, moderate, or high. A rating of very low-quality evidence means that we are uncertain about the results. A rating of high-quality evidence means that we are very certain about the results. For this Cochrane review, we found evidence of low quality. We included randomised controlled trials that were blinded, which means that participants and those people who assessed study results did not know whether participants had received cyclophosphamide or a placebo. However, the trials mostly included people with systemic sclerosis, so these results may not apply to all people with interstitial lung disease with connective tissue disease."
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query-laysum | 5322 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in Issue 4, 2008.\nPeople suffering from epilepsy have an increased risk of experiencing psychotic symptoms. The psychotic syndromes associated with epilepsy have generally been classified as ictal, postictal, and interictal psychosis. Anticonvulsant drugs have been reported to precipitate psychosis. Moreover, all antipsychotic drugs have the propensity to cause paroxysmal electroencephalogram abnormalities and induce seizures.\nObjectives\nTo evaluate the benefits of interventions used to treat clinically significant psychotic symptoms occurring in people with epilepsy with regard to global improvement, changes in mental state, hospitalization, behavior, quality of life, effect on the frequency of seizures, and interaction with antiepileptic drugs.\nSearch methods\nWe searched the Cochrane Epilepsy Group's Specialized Register (23 March 2015), the Cochrane Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies Online (CRSO), 23 March 2015), MEDLINE (Ovid, 1946 to 23 March 2015), PsycINFO (1887 to 23 March 2015), CINAHL (1937 to 23 March 2015), and BIOSIS Previews (1969 to 23 March 2015).\nTwo review authors (SF and AS) independently inspected the citations identified from the search. We identified potentially relevant abstracts and assessed full papers for inclusion and methodological quality.\nSelection criteria\nAll randomized controlled trials comparing drugs, behavior therapy, cognitive behavior therapy, or other non-pharmacological interventions used to relieve psychotic symptoms in people with epilepsy.\nData collection and analysis\nWe planned to extract and analyze the data from all relevant studies using standardized methods. As only one study met the inclusion criteria, we attempted no meta-analysis.\nMain results\nAfter independently assessing the abstracts and titles of 618 articles, we selected five relevant abstracts. Ultimately we found only one study meeting the inclusion criteria, which was available only as an abstract. This study compared the use of olanzapine (10 mg/day) with haloperidol (12 mg/day) in 16 people suffering from schizophrenia-like psychosis of epilepsy. Thirteen participants completed the study. Significant improvement was associated with use of olanzapine. We did not identify any study on psychosocial interventions in people suffering from epilepsy and psychosis.\nAuthors' conclusions\nWe found only one randomized controlled trial, which lacked the power to test the efficacy of antipsychotics in those suffering from psychosis concomitant with epilepsy.\nLimited evidence from this small randomized controlled trial suggests an improvement in psychotic symptoms, but not other outcome measures, with the use of an antipsychotic. The effects on seizure control are not well studied. Further trials are required to inform practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is substantial evidence that people suffering from epilepsy have an increased risk of suffering from psychotic symptoms. These symptoms sometimes occur soon after or before the epileptic seizures, but in some cases they can persist for a much longer time, even in the absence of seizures. The management of those suffering from psychosis related to epilepsy is complicated by the fact that most of the drugs used for controlling the symptoms of psychotic disorders can interfere with the effective control of epilepsy and vice versa."
}
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query-laysum | 5323 | [
{
"role": "user",
"content": "Abstract: Background\nLow vision rehabilitation aims to optimise the use of residual vision after severe vision loss, but also aims to teach skills in order to improve visual functioning in daily life. Other aims include helping people to adapt to permanent vision loss and improving psychosocial functioning. These skills promote independence and active participation in society. Low vision rehabilitation should ultimately improve quality of life (QOL) for people who have visual impairment.\nObjectives\nTo assess the effectiveness of low vision rehabilitation interventions on health-related QOL (HRQOL), vision-related QOL (VRQOL) or visual functioning and other closely related patient-reported outcomes in visually impaired adults.\nSearch methods\nWe searched relevant electronic databases and trials registers up to 18 September 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating HRQOL, VRQOL and related outcomes of adults, with an irreversible visual impairment (World Health Organization criteria). We included studies that compared rehabilitation interventions with active or inactive control.\nData collection and analysis\nWe used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 44 studies (73 reports) conducted in North America, Australia, Europe and Asia. Considering the clinical diversity of low vision rehabilitation interventions, the studies were categorised into four groups of related intervention types (and by comparator): (1) psychological therapies and/or group programmes, (2) methods of enhancing vision, (3) multidisciplinary rehabilitation programmes, (4) other programmes. Comparators were no care or waiting list as an inactive control group, usual care or other active control group. Participants included in the reported studies were mainly older adults with visual impairment or blindness, often as a result of age-related macular degeneration (AMD). Study settings were often hospitals or low vision rehabilitation services. Effects were measured at the short-term (six months or less) in most studies. Not all studies reported on funding, but those who did were supported by public or non-profit funders (N = 31), except for two studies.\nCompared to inactive comparators, we found very low-certainty evidence of no beneficial effects on HRQOL that was imprecisely estimated for psychological therapies and/or group programmes (SMD 0.26, 95% CI -0.28 to 0.80; participants = 183; studies = 1) and an imprecise estimate suggesting little or no effect of multidisciplinary rehabilitation programmes (SMD -0.08, 95% CI -0.37 to 0.21; participants = 183; studies = 2; I2 = 0%); no data were available for methods of enhancing vision or other programmes. Regarding VRQOL, we found low- or very low-certainty evidence of imprecisely estimated benefit with psychological therapies and/or group programmes (SMD -0.23, 95% CI -0.53 to 0.08; studies = 2; I2 = 24%) and methods of enhancing vision (SMD -0.19, 95% CI -0.54 to 0.15; participants = 262; studies = 5; I2 = 34%). Two studies using multidisciplinary rehabilitation programmes showed beneficial but inconsistent results, of which one study, which was at low risk of bias and used intensive rehabilitation, recorded a very large and significant effect (SMD: -1.64, 95% CI -2.05 to -1.24), and the other a small and uncertain effect (SMD -0.42, 95%: -0.90 to 0.07).\nCompared to active comparators, we found very low-certainty evidence of small or no beneficial effects on HRQOL that were imprecisely estimated with psychological therapies and/or group programmes including no difference (SMD -0.09, 95% CI -0.39 to 0.20; participants = 600; studies = 4; I2 = 67%). We also found very low-certainty evidence of small or no beneficial effects with methods of enhancing vision, that were imprecisely estimated (SMD -0.09, 95% CI -0.28 to 0.09; participants = 443; studies = 2; I2 = 0%) and multidisciplinary rehabilitation programmes (SMD -0.10, 95% CI -0.31 to 0.12; participants = 375; studies = 2; I2 = 0%). Concerning VRQOL, low-certainty evidence of small or no beneficial effects that were imprecisely estimated, was found with psychological therapies and/or group programmes (SMD -0.11, 95% CI -0.24 to 0.01; participants = 1245; studies = 7; I2 = 19%) and moderate-certainty evidence of small effects with methods of enhancing vision (SMD -0.24, 95% CI -0.40 to -0.08; participants = 660; studies = 7; I2 = 16%). No additional benefit was found with multidisciplinary rehabilitation programmes (SMD 0.01, 95% CI -0.18 to 0.20; participants = 464; studies = 3; I2 = 0%; low-certainty evidence).\nAmong secondary outcomes, very low-certainty evidence of a significant and large, but imprecisely estimated benefit on self-efficacy or self-esteem was found for psychological therapies and/or group programmes versus waiting list or no care (SMD -0.85, 95% CI -1.48 to -0.22; participants = 456; studies = 5; I2 = 91%). In addition, very low-certainty evidence of a significant and large estimated benefit on depression was found for psychological therapies and/or group programmes versus waiting list or no care (SMD -1.23, 95% CI -2.18 to -0.28; participants = 456; studies = 5; I2 = 94%), and moderate-certainty evidence of a small benefit versus usual care (SMD -0.14, 95% CI -0.25 to -0.04; participants = 1334; studies = 9; I2 = 0%). ln the few studies in which (serious) adverse events were reported, these seemed unrelated to low vision rehabilitation.\nAuthors' conclusions\nIn this Cochrane Review, no evidence of benefit was found of diverse types of low vision rehabilitation interventions on HRQOL. We found low- and moderate-certainty evidence, respectively, of a small benefit on VRQOL in studies comparing psychological therapies or methods for enhancing vision with active comparators.\nThe type of rehabilitation varied among studies, even within intervention groups, but benefits were detected even if compared to active control groups. Studies were conducted on adults with visual impairment mainly of older age, living in high-income countries and often having AMD. Most of the included studies on low vision rehabilitation had a short follow-up,\nDespite these limitations, the consistent direction of the effects in this review towards benefit justifies further research activities of better methodological quality including longer maintenance effects and costs of several types of low vision rehabilitation. Research on the working mechanisms of components of rehabilitation interventions in different settings, including low-income countries, is also needed.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low vision rehabilitation does not appear to have an important impact on health-related QOL however the evidence is very low-certainty. There is low-certainty evidence that some low vision rehabilitation interventions, particularly psychological therapies and methods of enhancing vision, may improve vision-related QOL in people with sight loss compared to usual care."
}
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query-laysum | 5324 | [
{
"role": "user",
"content": "Abstract: Background\nInhaled corticosteroids are well established for the long-term treatment of inflammatory respiratory diseases such as asthma or chronic obstructive pulmonary disease. They have been investigated for the treatment of coronavirus disease 2019 (COVID-19). The anti-inflammatory action of inhaled corticosteroids might have the potential to reduce the risk of severe illness resulting from hyperinflammation in COVID-19.\nObjectives\nTo assess whether inhaled corticosteroids are effective and safe in the treatment of COVID-19; and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which includes CENTRAL, PubMed, Embase, ClinicalTrials.gov, WHO ICTRP, and medRxiv), Web of Science (Science Citation Index, Emerging Citation Index), and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies to 7 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating inhaled corticosteroids for COVID-19, irrespective of disease severity, age, sex, or ethnicity.\nWe included the following interventions: any type or dose of inhaled corticosteroids. We included the following comparison: inhaled corticosteroids plus standard care versus standard care (with or without placebo).\nWe excluded studies examining nasal or topical steroids.\nData collection and analysis\nWe followed standard Cochrane methodology. For risk of bias assessment, we used the Cochrane RoB 2 tool. We rated the certainty of evidence using the GRADE approach for the outcomes of mortality, admission to hospital or death, symptom resolution, time to symptom resolution, serious adverse events, adverse events, and infections.\nMain results\nInhaled corticosteroids plus standard care versus standard care (with/without placebo)\nPeople with a confirmed diagnosis of moderate-to-severe COVID-19\nWe found no studies that included people with a confirmed diagnosis of moderate-to-severe COVID-19.\nPeople with a confirmed diagnosis of asymptomatic SARS-CoV-2 infection or mild COVID-19\nWe included three RCTs allocating 3607 participants, of whom 2490 had confirmed mild COVID-19. We analysed a subset of the total number of participants recruited to the studies (2171, 52% female) as some trials had a platform design where not all participants were allocated to treatment groups simultaneously. The included studies were community-based, recruiting people who were able to use inhaler devices to deliver steroids and relied on remote assessment and self-reporting of outcomes. Most people were older than 50 years and had co-morbidities such as hypertension, lung disease, or diabetes. The studies were conducted in high-income countries prior to wide-scale vaccination programmes. A total of 1057 participants were analysed in the inhaled corticosteroid arm (budesonide: 860 participants; ciclesonide: 197 participants), and 1075 participants in the control arm. No studies included people with asymptomatic SARS-CoV-2 infection.\nWith respect to the following outcomes, inhaled corticosteroids compared to standard care:\n– may result in little to no difference in all-cause mortality (at up to day 30) (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.22 to 1.67; 2132 participants; low-certainty evidence). In absolute terms, this means that for every nine deaths per 1000 people not receiving inhaled corticosteroids, there were six deaths per 1000 people who did receive the intervention (95% CI 2 to 16 per 1000 people);\n– probably reduces admission to hospital or death (at up to 30 days) (RR 0.72, 95% CI 0.51 to 0.99; 2025 participants; moderate-certainty evidence);\n– probably increases resolution of all initial symptoms at day 14 (RR 1.19, 95% CI 1.09 to 1.30; 1986 participants; moderate-certainty evidence);\n– may reduce the duration to symptom resolution (at up to day 30) (by −4.00 days, 95% CI −6.22 to −1.78 less than control group rate of 12 days; 139 participants; low-certainty evidence);\n– the evidence is very uncertain about the effect on serious adverse events (during study period) (RR 0.51, 95% CI 0.09 to 2.76; 1586 participants; very low-certainty evidence);\n– may result in little to no difference in adverse events (at up to day 30) (RR 0.78, 95% CI 0.47 to 1.31; 400 participants; low-certainty evidence);\n– may result in little to no difference in infections (during study period) (RR 0.88, 95% CI 0.30 to 2.58; 400 participants; low-certainty evidence).\nAs studies did not report outcomes for subgroups (e.g. age, ethnicity, sex), we did not perform subgroup analyses.\nAuthors' conclusions\nIn people with confirmed COVID-19 and mild symptoms who are able to use inhaler devices, we found moderate-certainty evidence that inhaled corticosteroids probably reduce the combined endpoint of admission to hospital or death and increase the resolution of all initial symptoms at day 14. Low-certainty evidence suggests that corticosteroids make little to no difference in all-cause mortality up to day 30 and may decrease the duration to symptom resolution. We do not know whether inhaled corticosteroids increase or decrease serious adverse events due to heterogeneity in the way they were reported across the studies. There is low-certainty evidence that inhaled corticosteroids may decrease infections.\nThe evidence we identified came from studies in high-income settings using budesonide and ciclesonide prior to vaccination roll-outs.\nWe identified a lack of evidence concerning quality of life assessments, serious adverse events, and people with asymptomatic infection or with moderate-to-severe COVID-19. The 10 ongoing and four completed, unpublished RCTs that we identified in trial registries address similar settings and research questions as in the current body of evidence. We expect to incorporate the findings of these studies in future versions of this review.\nWe monitor newly published results of RCTs on inhaled corticosteroids on a weekly basis and will update the review when the evidence or our certainty in the evidence changes.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies compared inhaled corticosteroids plus usual care compared to usual care with or without placebo in people with a confirmed diagnosis of mild COVID-19. These studies analysed 2171 participants mostly older than 50 years and with other medical problems, 52% of them were female, of whom 1057 received inhaled corticosteroids in our analyses. We found no studies that included people with asymptomatic infection or confirmed diagnosis of moderate-to-severe COVID-19.\nWe also found 10 ongoing studies, and four completed studies without published results."
}
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query-laysum | 5325 | [
{
"role": "user",
"content": "Abstract: Background\nPsoriasis is an inflammatory skin disease that presents with itching, red, scaling plaques; its worsening has been associated with obesity, drinking, smoking, lack of sleep, and a sedentary lifestyle. Lifestyle changes may improve psoriasis.\nObjectives\nTo assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions.\nSearch methods\nWe searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched the China National Knowledge Infrastructure, the Airiti Library, and five trials registers up to July 2018. We checked the references of included trials for further relevant trials, and we asked the authors of the included trials if they were aware of any relevant unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) of lifestyle changes (either alone or in combination) for treating psoriasis in people diagnosed by a healthcare professional. Treatment had to be given for at least 12 weeks. Eligible comparisons were no lifestyle changes or another active intervention.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome measures were 'Severity of psoriasis' and 'Adherence to the intervention'. Secondary outcomes were 'Quality of life', 'Time to relapse', and 'Reduction in comorbidities'. We used GRADE to assess the quality of the evidence for each outcome.\nMain results\nWe included 10 RCTs with 1163 participants (mean age: 43 to 61 years; 656 men and 478 women were reported). Six trials examined the effects of dietary intervention (low-calorie diet) in 499 obese participants (mean age: 44.3 to 61 years; where reported, 395 had moderate-to-severe psoriasis). One trial assessed a combined dietary intervention and exercise programme in 303 obese participants with moderate-to-severe psoriasis who had started a systemic therapy for psoriasis and had not achieved clearance after four weeks of continuous treatment (median age: 53 years). Another trial assessed a walking exercise and continuous health education in 200 participants (mean age: 43.1 years, severity not reported). Finally, two trials included education programmes promoting a healthy lifestyle in 161 participants (aged 18 to 78 years), with one trial on mild psoriasis and the other trial not reporting severity.\nComparisons included information only; no intervention; medical therapy alone; and usual care (such as continuing healthy eating).\nAll trials were conducted in hospitals and treated participants for between 12 weeks and three years. One trial did not report the treatment period. Seven trials measured the outcomes at the end of treatment and there was no additional follow-up. In two trials, there was follow-up after the treatment ended. Five trials had a high risk of performance bias, and four trials had a high risk of attrition bias.\nWe found no trials assessing interventions for alcohol abstinence or smoking cessation. No trials assessed time to relapse. Only two trials assessed adverse events; in one trial these were caused by the add-on therapy ciclosporin (given in both groups). The trial comparing two dietary interventions to a no-treatment group observed no adverse events.\nThe results presented in this abstract are based on trials of obese participants.\nOutcomes for dietary interventions versus usual care were measured 24 weeks to six months from baseline. Compared to usual care, dietary intervention (strict caloric restriction) may lead to 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) (risk ratio (RR) 1.66, 95% confidence interval (CI) 1.07 to 2.58; 2 trials, 323 participants; low-quality evidence). Adherence to the intervention may be greater with the dietary intervention than usual care, but the 95% CI indicates that the dietary intervention might also make little or no difference (RR 1.26, 95% CI 0.76 to 2.09; 2 trials, 105 participants; low-quality evidence). Dietary intervention probably achieves a greater improvement in dermatology quality-of-life index (DLQI) score compared to usual care (MD −12.20, 95% CI −13.92 to −10.48; 1 trial, 36 participants; moderate-quality evidence), and probably reduces the BMI compared to usual care (MD −4.65, 95% CI −5.93 to −3.36; 2 trials, 78 participants; moderate-quality evidence).\nOutcomes for dietary interventions plus exercise programme were measured 16 weeks from baseline and are based on one trial (303 participants). Compared to information only (on reducing weight to improve psoriasis), combined dietary intervention and exercise programme (dietetic plan and physical activities) probably improves psoriasis severity, but the 95% CI indicates that the intervention might make little or no difference (PASI 75: RR 1.28, 95% CI 0.83 to 1.98). This combined intervention probably results in a greater reduction in BMI (median change −1.10 kg/m², P = 0.002), but there is probably no difference in adherence (RR 0.95, 95% CI 0.89 to 1.01; 137/151 and 145/152 participants adhered in the treatment and control group, respectively). There were no data on quality of life. These outcomes are based on moderate-quality evidence.\nAuthors' conclusions\nDietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence). None of the trials measured quality of life.\nWe did not detect a clear difference in treatment adherence between those in the combined dietary intervention and exercise programme group and those given information only (moderate-quality evidence). Adherence may be improved through dietary intervention compared with usual care (low-quality evidence). Participants generally adhered well to the lifestyle interventions assessed in the review.\nNo trials assessed the time to relapse. Trial limitations included unblinded participants and high dropout rate.\nFuture trials should reduce dropouts and include comprehensive outcome measures; they should examine whether dietary intervention with or without an exercise programme is effective in non-obese people with psoriasis, whether an additional exercise programme is more effective than dietary intervention alone, whether the time to relapse prolongs in people who receive dietary intervention with or without exercise programme, and whether smoking cessation and alcohol abstinence are effective in treating psoriasis.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Psoriasis is a long-lasting, inflammatory skin disease; it causes thick, red, itching, and scaling patches. Obesity, drinking, smoking, and an inactive lifestyle can worsen psoriasis. We intended to find out if lifestyle changes can improve psoriasis severity and quality of life, and reduce comorbidities (other conditions occurring alongside a primary condition)."
}
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query-laysum | 5326 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent treatments for amblyopia, typically patching or pharmacological blurring, have limited success. Less than two-thirds of children achieve good acuity of 0.20 logMAR in the amblyopic eye, with limited improvement of stereopsis, and poor adherence to treatment. A new approach, based on presentation of movies or computer games separately to each eye, may yield better results and improve adherence. These treatments aim to balance the input of visual information from each eye to the brain.\nObjectives\nTo determine whether binocular treatments in children, aged three to eight years, with unilateral amblyopia result in better visual outcomes than conventional patching or pharmacological blurring treatment.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to 19 November 2020, with no language restrictions.\nSelection criteria\nTwo review authors independently screened the results of the search for relevant studies. We included randomised controlled trials (RCTs) that enrolled children between the ages of three and eight years old with unilateral amblyopia. Amblyopia was classed as present when the best-corrected visual acuity (BCVA) was worse than 0.200 logMAR in the amblyopic eye, with BCVA 0.200 logMAR or better in the fellow eye, in the presence of an amblyogenic risk factor, such as anisometropia, strabismus, or both. To be eligible, children needed to have undergone cycloplegic refraction and ophthalmic examination, including fundal examination and optical treatment, if indicated, with stable BCVA in the amblyopic eye despite good adherence with wearing glasses. We included any type of binocular viewing intervention, on any device (e.g. computer monitors viewed with liquid-crystal display shutter glasses; hand-held screens, including mobile phones with lenticular prism overlay; or virtual reality displays). Control groups received standard amblyopia treatment, which could include patching or pharmacological blurring of the better-seeing eye. We included full-time (all waking hours) and part-time (between 1 and 12 hours a day) patching regimens.\nWe excluded children who had received any treatment other than optical treatment; and studies with less than 8-week follow-up.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome of the review was the change from baseline of distance BCVA in the amblyopic eye after 16 (± 2) weeks of treatment, measured in logMAR units on an age-appropriate acuity test.\nMain results\nWe identified one eligible RCT of conventional patching treatment versus novel binocular treatment, and analysed a subset of 68 children who fulfilled the age criterion of this review. We obtained data for the mean change in amblyopic eye visual acuity, adverse events (diplopia), and adherence to prescribed treatment at 8- and 16-week follow-up intervals, though no data were available for change in BCVA after 52 weeks. Risk of bias for the included study was considered to be low.\nThe certainty of evidence for the visual acuity outcomes at 8 and 16 weeks of treatment and adherence to the study intervention was rated moderate using the GRADE criteria, downgrading by one level due to imprecision. The certainty of evidence was downgraded by two levels and rated low for the proportion of participants reporting adverse events due to the sample size.\nAcuity improved in the amblyopic eye in both the binocular and patching groups following 16 weeks of treatment (improvement of -0.21 logMAR in the binocular group and -0.24 logMAR in the patching group), mean difference (MD) 0.03 logMAR (95% confidence interval (CI) -0.10 to 0.04; 63 children). This difference was non-significant and the improvements in both the binocular and patching groups are also considered clinically similar.\nFollowing 8 weeks of treatment, acuity improved in both the binocular and patching groups (improvement of -0.18 logMAR in the patching group compared to -0.16 logMAR improvement in the binocular-treatment group) (MD 0.02, 95% CI -0.04 to 0.08). Again this difference was statistically non-significant, and the differences observed between the patching and binocular groups are also clinically non-significant. No adverse event of permanent diplopia was reported.\nAdherence was higher in the patching group (47% of participants in the iPad group achieved over 75% compliance compared with 90% of the patching group).\nData were not available for changes in stereopsis nor for contrast sensitivity following treatment.\nAuthors' conclusions\nCurrently, there is only one RCT that offers evidence of the safety and effectiveness of binocular treatment.\nThe authors are moderately confident that after 16 weeks of treatment, the gain in amblyopic eye acuity with binocular treatment is likely comparable to that of conventional patching treatment. However, due to the limited sample size and lack of long term (52 week) follow-up data, it is not yet possible to draw robust conclusions regarding the overall safety and sustained effectiveness of binocular treatment.\nFurther research, using acknowledged methods of visual acuity and stereoacuity assessment with known reproducibility, is required to inform decisions about the implementation of binocular treatments for amblyopia in clinical practice, and should incorporate longer term follow-up to establish the effectiveness of binocular treatment. Randomised controlled trials should also include outcomes reported by users, adherence to prescribed treatment, and recurrence of amblyopia after cessation of treatment.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that examined this new treatment, compared with standard patching or eye-drop blurring treatment, in children aged three to eight years with lazy eye. We searched all standard sources of information. Two review authors independently reviewed the results of this search. We planned to include only studies reporting results from randomised controlled trials (RCTs) - studies comparing the new treatment with a standard treatment, and where children were assigned treatment groups at random (like flipping a coin)."
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query-laysum | 5327 | [
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep apnoea syndrome (OSAS) is associated with several chronic diseases, including erectile dysfunction (ED). The association of OSAS and ED is far more common than might be found by chance; the treatment of OSAS with non-invasive positive airway pressure therapy is associated with improvement of respiratory symptoms, and may contribute to the improvement of associated conditions, such as ED.\nObjectives\nTo assess the effectiveness and acceptability of non-invasive positive airway pressure therapy for improving erectile dysfunction in OSAS.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, AMED EBSCO, and LILACS, the US National Institutes of Health ongoing trials register ClinicalTrials.gov, and the World Health Organisation international clinical trials registry platform to 14 June 2021, with no restriction on date, language, or status of publication. We checked the reference lists of all primary studies, and review articles for additional references, and relevant manufacturers' websites for study information. We also searched specific conference proceedings for the British Association of Urological Surgeons; the European Association of Urology; and the American Urological Association to 14 June 2021.\nSelection criteria\nWe considered randomised controlled trials (RCTs) with a parallel or cross-over design, or cluster-RCTs, which included men aged 18 years or older, with OSAS and ED. We considered RCTs comparing any non-invasive positive airway pressure therapy (such as continuous positive airways pressure (CPAP), bilevel positive airway pressure (BiPAP), variable positive airway pressure (VPAP), or similar devices) versus sham, no treatment, waiting list, or pharmacological treatment for ED. The primary outcomes were remission of ED and serious adverse events; secondary outcome were sex-related quality of life, health-related quality of life, and minor adverse events.\nData collection and analysis\nTwo review authors independently conducted study selection, data extraction, and risk of bias assessment. A third review author solved any disagreement. We used the Cochrane RoB 1 tool to assess the risk of bias of the included RCTs. We used the GRADE approach to assess the certainty of the body of evidence. To measure the treatment effect on dichotomous outcomes, we used the risk ratio (RR); for continuous outcomes, we used the mean difference (MD). We calculated 95% confidence intervals (CI) for these measures. When possible (data availability and homogeneous studies), we used a random-effect model to pool data with a meta-analysis.\nMain results\nWe included six RCTs (all assessing CPAP as the non-invasive positive airway pressure therapy device), with a total of 315 men with OSAS and ED. All RCTs presented some important risk of bias related to selection, performance, assessment, or reporting bias. None of included RCTs assessed the ED remission rate, and we used the provided ED mean scores as a proxy.\nCPAP versus no CPAP\nThere is uncertainty about the effect of CPAP on mean ED scores after 4 weeks, using the International index of erectile function (IIEF-5, higher = better; MD 7.50, 95% CI 4.05 to 10.95; 1 RCT; 27 participants; very low-certainty evidence), and after 12 weeks (IIEF-ED, ED domain; MD 2.50, 95% CI -1.10 to 6.10; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, using the Self-esteem and relationship test (SEAR, higher = better; MD 1.00, 95% CI -8.09 to 10.09; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision); no serious adverse events were reported after 4 weeks (1 RCT; 27 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision).\nCPAP versus sham CPAP\nOne RCT assessed this comparison (61 participants), but we were unable to extract outcomes for this comparison due to the factorial design and reporting of this trial.\nCPAP versus sildenafil (phosphodiesterase type 5 inhibitors)\nSildenafil may slightly improve erectile function at 12 weeks when compared to CPAP, measured with the IIEF-ED (MD -4.78, 95% CI -6.98 to -2.58; 3 RCTs; 152 participants; I² = 59%; low-certainty evidence, downgraded due to methodological limitations).\nThere is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, measured with the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS, higher = better; MD -1.24, 95% CI -1.80 to -0.67; 2 RCTs; 122 participants; I² = 0%; very low-certainty evidence, downgraded due to methodological limitations). No serious adverse events were reported for either group (2 RCTs; 70 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effects of CPAP when compared to sildenafil for the incidence of minor adverse events (RR 1.33, 95% CI 0.34 to 5.21; 1 RCT; 40 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). The confidence interval was wide and neither a significant increase nor reduction in the risk of minor adverse events can be ruled out with the use of CPAP (4/20 men complained of nasal dryness in the CPAP group, and 3/20 men complained of transient flushing and mild headache in the sildenafil group).\nAuthors' conclusions\nWhen compared with no CPAP, we are uncertain about the effectiveness and acceptability of CPAP for improving erectile dysfunction in men with obstructive sleep apnoea. When compared with sildenafil, there is some evidence that sildenafil may slightly improve erectile function at 12 weeks.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The purpose of this review was to assess the effectiveness and acceptability of non-invasive positive airway pressure therapy for improving erectile dysfunction (ED) in men with obstructive sleep apnoea (OSAS)."
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query-laysum | 5328 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis (OA) of the hip is a progressive condition that has no cure and often requires a total hip arthroplasty (THA). The principal methods for THA are the posterior and direct lateral approaches. The posterior approach is considered to be easy to perform, however, increased rates of dislocation have been reported. The direct lateral approach facilitates cup positioning which may decrease rates of hip dislocation and diminishes the risk of injury to the sciatic nerve. However, there is an increased risk of limp. Dislocation of a hip prosthesis is a clinically important complication after THA, in terms of morbidity implications and costs.\nObjectives\nTo determine the risks of prosthesis dislocation, postoperative Trendelenburg gait and sciatic nerve palsy after a posterior approach, compared to a direct lateral approach, for adult patients undergoing THA for primary OA and to update the previous review made in 2003.\nSearch methods\nMEDLINE, EMBASE, CINAHL and Cochrane databases were searched and updated, from the previous search of 2002, to Oct 13, 2005. No language restrictions were applied.\nSelection criteria\nPublished trials comparing posterior and direct lateral surgical approaches to THA in participants 18 years and older with a diagnosis of primary hip OA.\nData collection and analysis\nRetrieved articles were assessed independently by the two reviewers for their methodological quality.\nMain results\nFour prospective cohort studies involving 241 participants met the inclusion criteria. The primary outcome, dislocation, was reported in two studies. No significant difference between posterior and direct lateral surgical approach was found [1/77 (1.3%) versus 3/72 (4.2%); relative risk (RR) 0.35; 95% confidence intervals (CI) 0.04 to 3.22]. The presence of postoperative Trendelenburg gait was not significantly different between these surgical approaches. The risk of nerve palsy or injury (all nerves taken together) was significantly higher among the direct lateral approaches [1/43 (2%) versus 10/49 (20%); RR 0.16, 95% CI 0.03 to 0.83]. However, there were no significant differences when comparing this risk nerve by nerve for both approaches, in particular for the sciatic nerve. Of the other outcomes considered only the average range of internal rotation in extension of the hip was significantly higher (weighted mean difference 16 degrees, 95% CI 8 to 23) in the posterior approach group (mean 35°, standard deviation 13°) compared to the direct lateral approach (mean 19°, standard deviation 13°).\nAuthors' conclusions\nThe quality and quantity of information extracted from the trials performed to date are insufficient to make any firm conclusion on the optimum choice of surgical approach in adult patients undergoing primary THA for OA.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoarthritis of the hip and what types of total hip replacement surgery are there?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Osteoarthritis (OA) is the most common form of arthritis that can affect the hips. In some people, the damage and pain in the hip may be severe enough for surgery. In these people, the whole hip joint can be replaced by an artificial joint with total hip replacement surgery.\nIn total hip replacement surgery, the surgeon can make the cut from the posterior (back) or lateral (side) of the hip. Some surgeons believe that the posterior approach is better because people may have less problems walking after surgery. Other surgeons believe that the lateral approach is better because people may have less chance of nerve damage and less chance of dislocating their hip after surgery. Dislocating a hip causes pain and people may need to go to hospital to put the hip back in place."
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query-laysum | 5329 | [
{
"role": "user",
"content": "Abstract: Background\nHyperimmune immunoglobulin (hIVIG) contains polyclonal antibodies, which can be prepared from large amounts of pooled convalescent plasma or prepared from animal sources through immunisation. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). This review was previously part of a parent review addressing convalescent plasma and hIVIG for people with COVID-19 and was split to address hIVIG and convalescent plasma separately.\nObjectives\nTo assess the benefits and harms of hIVIG therapy for the treatment of people with COVID-19, and to maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nTo identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Research Database, the Cochrane COVID-19 Study Register, the Epistemonikos COVID-19 L*OVE Platform and Medline and Embase from 1 January 2019 onwards. We carried out searches on 31 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated hIVIG for COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies that evaluated standard immunoglobulin.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies, we used RoB 2. We rated the certainty of evidence, using the GRADE approach, for the following outcomes: all-cause mortality, improvement and worsening of clinical status (for individuals with moderate to severe disease), quality of life, adverse events, and serious adverse events.\nMain results\nWe included five RCTs with 947 participants, of whom 688 received hIVIG prepared from humans, 18 received heterologous swine glyco-humanised polyclonal antibody, and 241 received equine-derived processed and purified F(ab’)2 fragments. All participants were hospitalised with moderate-to-severe disease, most participants were not vaccinated (only 12 participants were vaccinated). The studies were conducted before or during the emergence of several SARS-CoV-2 variants of concern.\nThere are no data for people with COVID-19 with no symptoms (asymptomatic) or people with mild COVID-19. We identified a further 10 ongoing studies evaluating hIVIG.\nBenefits of hIVIG prepared from humans\nWe included data on one RCT (579 participants) that assessed the benefits and harms of hIVIG 0.4 g/kg compared to saline placebo. hIVIG may have little to no impact on all-cause mortality at 28 days (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.43 to 1.44; absolute effect 77 per 1000 with placebo versus 61 per 1000 (33 to 111) with hIVIG; low-certainty evidence). The evidence is very uncertain about the effect on worsening of clinical status at day 7 (RR 0.85, 95% CI 0.58 to 1.23; very low-certainty evidence). It probably has little to no impact on improvement of clinical status on day 28 (RR 1.02, 95% CI 0.97 to 1.08; moderate-certainty evidence). We did not identify any studies that reported quality-of-life outcomes, so we do not know if hIVIG has any impact on quality of life.\nHarms of hIVIG prepared from humans\nhIVIG may have little to no impact on adverse events at any grade on day 1 (RR 0.98, 95% CI 0.81 to 1.18; 431 per 1000; 1 study 579 participants; low-certainty evidence). Patients receiving hIVIG probably experience more adverse events at grade 3-4 severity than patients who receive placebo (RR 4.09, 95% CI 1.39 to 12.01; moderate-certainty evidence). hIVIG may have little to no impact on the composite outcome of serious adverse events or death up to day 28 (RR 0.72, 95% CI 0.45 to 1.14; moderate-certainty evidence).\nWe also identified additional results on the benefits and harms of other dose ranges of hIVIG, not included in the summary of findings table, but summarised in additional tables.\nBenefits of animal-derived polyclonal antibodies\nWe included data on one RCT (241 participants) to assess the benefits and harms of receptor-binding domain-specific polyclonal F(ab´)2 fragments of equine antibodies (EpAbs) compared to saline placebo. EpAbs may reduce all-cause mortality at 28 days (RR 0.60, 95% CI 0.26 to 1.37; absolute effect 114 per 1000 with placebo versus 68 per 1000 (30 to 156) ; low-certainty evidence). EpAbs may reduce worsening of clinical status up to day 28 (RR 0.67, 95% CI 0.38 to 1.18; absolute effect 203 per 1000 with placebo versus 136 per 1000 (77 to 240); low-certainty evidence). It may have some effect on improvement of clinical status on day 28 (RR 1.06, 95% CI 0.96 to 1.17; low-certainty evidence). We did not identify any studies that reported quality-of-life outcomes, so we do not know if EpAbs have any impact on quality of life.\nHarms of animal-derived polyclonal antibodies\nEpAbs may have little to no impact on the number of adverse events at any grade up to 28 days (RR 0.99, 95% CI 0.74 to 1.31; low-certainty evidence). Adverse events at grade 3-4 severity were not reported. Individuals receiving EpAbs may experience fewer serious adverse events than patients receiving placebo (RR 0.67, 95% CI 0.38 to 1.19; low-certainty evidence).\nWe also identified additional results on the benefits and harms of other animal-derived polyclonal antibody doses, not included in the summary of findings table, but summarised in additional tables.\nAuthors' conclusions\nWe included data from five RCTs that evaluated hIVIG compared to standard therapy, with participants with moderate-to-severe disease. As the studies evaluated different preparations (from humans or from various animals) and doses, we could not pool them. hIVIG prepared from humans may have little to no impact on mortality, and clinical improvement and worsening. hIVIG may increase grade 3-4 adverse events. Studies did not evaluate quality of life. RBD-specific polyclonal F(ab´)2 fragments of equine antibodies may reduce mortality and serious adverse events, and may reduce clinical worsening. However, the studies were conducted before or during the emergence of several SARS-CoV-2 variants of concern and prior to widespread vaccine rollout.\nAs no studies evaluated hIVIG for participants with asymptomatic infection or mild disease, benefits for these individuals remains uncertain.\nThis is a living systematic review. We search monthly for new evidence and update the review when we identify relevant new evidence.\n\nGiven the provided abstract, please respond to the following query: \"What is hyperimmune immunoglobulin?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The body produces antibodies as one of its defences against infection. Antibodies, or 'immunoglobulins', are found in blood plasma. They act as a critical part of the immune response.\nPlasma from people who have recovered from COVID-19 contains COVID-19 antibodies, and can be used to make two preparations. Firstly, it can be used to make convalescent plasma, which is plasma that contains these antibodies. Secondly, it can be used to make hyperimmune immunoglobulin, which is more concentrated, and therefore contains more antibodies. The manufacturing process of hyperimmune immunoglobulin is complex and requires large pools of human plasma.\nSimilar antibodies can be made from animal sources and used in humans."
}
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query-laysum | 5330 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotics can disturb gastrointestinal microbiota which may lead to reduced resistance to pathogens such as Clostridium difficile (C. difficile). Probiotics are live microbial preparations that, when administered in adequate amounts, may confer a health benefit to the host, and are a potential C. difficile prevention strategy. Recent clinical practice guidelines do not recommend probiotic prophylaxis, even though probiotics have the highest quality evidence among cited prophylactic therapies.\nObjectives\nTo assess the efficacy and safety of probiotics for preventing C.difficile-associated diarrhea (CDAD) in adults and children.\nSearch methods\nWe searched PubMed, EMBASE, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 21 March 2017. Additionally, we conducted an extensive grey literature search.\nSelection criteria\nRandomized controlled (placebo, alternative prophylaxis, or no treatment control) trials investigating probiotics (any strain, any dose) for prevention of CDAD, or C. difficile infection were considered for inclusion.\nData collection and analysis\nTwo authors (independently and in duplicate) extracted data and assessed risk of bias. The primary outcome was the incidence of CDAD. Secondary outcomes included detection of C. difficile infection in stool, adverse events, antibiotic-associated diarrhea (AAD) and length of hospital stay. Dichotomous outcomes (e.g. incidence of CDAD) were pooled using a random-effects model to calculate the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. Continuous outcomes (e.g. length of hospital stay) were pooled using a random-effects model to calculate the mean difference and corresponding 95% CI. Sensitivity analyses were conducted to explore the impact of missing data on efficacy and safety outcomes. For the sensitivity analyses, we assumed that the event rate for those participants in the control group who had missing data was the same as the event rate for those participants in the control group who were successfully followed. For the probiotic group, we calculated effects using the following assumed ratios of event rates in those with missing data in comparison to those successfully followed: 1.5:1, 2:1, 3:1, and 5:1. To explore possible explanations for heterogeneity, a priori subgroup analyses were conducted on probiotic species, dose, adult versus pediatric population, and risk of bias as well as a post hoc subgroup analysis on baseline risk of CDAD (low 0% to 2%; moderate 3% to 5%; high > 5%). The overall quality of the evidence supporting each outcome was independently assessed using the GRADE criteria.\nMain results\nThirty-nine studies (9955 participants) met the eligibility requirements for our review. Overall, 27 studies were rated as either high or unclear risk of bias. A complete case analysis (i.e. participants who completed the study) among trials investigating CDAD (31 trials, 8672 participants) suggests that probiotics reduce the risk of CDAD by 60%. The incidence of CDAD was 1.5% (70/4525) in the probiotic group compared to 4.0% (164/4147) in the placebo or no treatment control group (RR 0.40, 95% CI 0.30 to 0.52; GRADE = moderate). Twenty-two of 31 trials had missing CDAD data ranging from 2% to 45%. Our complete case CDAD results proved robust to sensitivity analyses of plausible and worst-plausible assumptions regarding missing outcome data and results were similar whether considering subgroups of trials in adults versus children, inpatients versus outpatients, different probiotic species, lower versus higher doses of probiotics, or studies at high versus low risk of bias. However, in a post hoc analysis, we did observe a subgroup effect with respect to baseline risk of developing CDAD. Trials with a baseline CDAD risk of 0% to 2% and 3% to 5% did not show any difference in risk but trials enrolling participants with a baseline risk of > 5% for developing CDAD demonstrated a large 70% risk reduction (interaction P value = 0.01). Among studies with a baseline risk > 5%, the incidence of CDAD in the probiotic group was 3.1% (43/1370) compared to 11.6% (126/1084) in the control group (13 trials, 2454 participants; RR 0.30, 95% CI 0.21 to 0.42; GRADE = moderate). With respect to detection of C. difficile in the stool pooled complete case results from 15 trials (1214 participants) did not show a reduction in infection rates. C. difficile infection was 15.5% (98/633) in the probiotics group compared to 17.0% (99/581) in the placebo or no treatment control group (RR 0.86, 95% CI 0.67 to 1.10; GRADE = moderate). Adverse events were assessed in 32 studies (8305 participants) and our pooled complete case analysis indicates probiotics reduce the risk of adverse events by 17% (RR 0.83, 95% CI 0.71 to 0.97; GRADE = very low). In both treatment and control groups the most common adverse events included abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance.\nAuthors' conclusions\nBased on this systematic review and meta-analysis of 31 randomized controlled trials including 8672 patients, moderate certainty evidence suggests that probiotics are effective for preventing CDAD (NNTB = 42 patients, 95% CI 32 to 58). Our post hoc subgroup analyses to explore heterogeneity indicated that probiotics are effective among trials with a CDAD baseline risk >5% (NNTB = 12; moderate certainty evidence), but not among trials with a baseline risk ≤5% (low to moderate certainty evidence). Although adverse effects were reported among 32 included trials, there were more adverse events among patients in the control groups. The short-term use of probiotics appears to be safe and effective when used along with antibiotics in patients who are not immunocompromised or severely debilitated. Despite the need for further research, hospitalized patients, particularly those at high risk of CDAD, should be informed of the potential benefits and harms of probiotics.\n\nGiven the provided abstract, please respond to the following query: \"What is Clostridium difficile-associated diarrhea?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Clostridium difficile-associated diarrhea?\nAntibiotics are among the most prescribed medications worldwide. Antibiotic treatment may disturb the balance of organisms that normally populate the gut. This can result in a range of symptoms, most notably, diarrhea. Clostridium difficile (C. difficile) is a particularly dangerous organism that may colonize the gut if the normal healthy balance has been disturbed. Clostridium difficile-related disease varies from asymptomatic infection, diarrhea, colitis, and pseudo-membranous colitis to toxic megacolon and death. The cost of treatment is expensive and the financial burden on the medical system is substantial."
}
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query-laysum | 5331 | [
{
"role": "user",
"content": "Abstract: Background\nElbow supracondylar fractures are common, with treatment decisions based on fracture displacement. However, there remains controversy regarding the best treatments for this injury.\nObjectives\nTo assess the effects (benefits and harms) of interventions for treating supracondylar elbow fractures in children.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase in March 2021. We also searched trial registers and reference lists. We applied no language or publication restrictions.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing different interventions for the treatment of supracondylar elbow fractures in children. We included studies investigating surgical interventions (different fixation techniques and different reduction techniques), surgical versus non-surgical treatment, traction types, methods of non-surgical intervention, and timing and location of treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We collected data and conducted GRADE assessment for five critical outcomes: functional outcomes, treatment failure (requiring re-intervention), nerve injury, major complications (pin site infection in most studies), and cosmetic deformity (cubitus varus).\nMain results\nWe included 52 trials with 3594 children who had supracondylar elbow fractures; most were Gartland 2 and 3 fractures. The mean ages of children ranged from 4.9 to 8.4 years and the majority of participants were boys. Most studies (33) were conducted in countries in South-East Asia.\nWe identified 12 different comparisons of interventions: retrograde lateral wires versus retrograde crossed wires; lateral crossed (Dorgan) wires versus retrograde crossed wires; retrograde lateral wires versus lateral crossed (Dorgan) wires; retrograde crossed wires versus posterior intrafocal wires; retrograde lateral wires in a parallel versus divergent configuration; retrograde crossed wires using a mini-open technique or inserted percutaneously; buried versus non-buried wires; external versus internal fixation; open versus closed reduction; surgical fixation versus non-surgical immobilisation; skeletal versus skin traction; and collar and cuff versus backslab.\nWe report here the findings of four comparisons that represent the most substantial body of evidence for the most clinically relevant comparisons.\nAll studies in these four comparisons had unclear risks of bias in at least one domain. We downgraded the certainty of all outcomes for serious risks of bias, for imprecision when evidence was derived from a small sample size or had a wide confidence interval (CI) that included the possibility of benefits or harms for both treatments, and when we detected the possibility of publication bias.\nRetrograde lateral wires versus retrograde crossed wires (29 studies, 2068 children)\nThere was low-certainty evidence of less nerve injury with retrograde lateral wires (RR 0.65, 95% CI 0.46 to 0.90; 28 studies, 1653 children). In a post hoc subgroup analysis, we noted a greater difference in the number of children with nerve injuries when lateral wires were compared to crossed wires inserted with a percutaneous medial wire technique (RR 0.41, 95% CI 0.20 to 0.81, favours lateral wires; 10 studies, 552 children), but little difference when an open technique was used (RR 0.91, 95% CI 0.59 to 1.40, favours lateral wires; 11 studies, 656 children). Although we noted a statistically significant difference between these subgroups from the interaction test (P = 0.05), we could not rule out the possibility that other factors could account for this difference.\nWe found little or no difference between the interventions in major complications, which were described as pin site infections in all studies (RR 1.08, 95% CI 0.65 to 1.79; 19 studies, 1126 children; low-certainty evidence). For functional status (1 study, 35 children), treatment failure requiring re-intervention (1 study, 60 children), and cosmetic deformity (2 studies, 95 children), there was very low-certainty evidence showing no evidence of a difference between interventions.\nOpen reduction versus closed reduction (4 studies, 295 children)\nType of reduction method may make little or no difference to nerve injuries (RR 0.30, 95% CI 0.09 to 1.01, favours open reduction; 3 studies, 163 children). However, there may be fewer major complications (pin site infections) when closed reduction is used (RR 4.15, 95% CI 1.07 to 16.20; 4 studies, 253 children). The certainty of the evidence for these outcomes is low. No studies reported functional outcome, treatment failure requiring re-intervention, or cosmetic deformity. The four studies in this comparison used direct visualisation during surgery. One additional study used a joystick technique for reduction, and we did not combine data from this study in analyses.\nSurgical fixation using wires versus non-surgical immobilisation using a cast (3 studies, 140 children)\nThere was very low-certainty evidence showing little or no difference between interventions for treatment failure requiring re-intervention (1 study, 60 children), nerve injury (3 studies, 140 children), major complications (3 studies, 126 children), and cosmetic deformity (2 studies, 80 children). No studies reported functional outcome.\nBackslab versus sling (1 study, 50 children)\nNo nerve injuries or major complications were experienced by children in either group; this evidence is of very low certainty. Functional outcome, treatment failure, and cosmetic deformity were not reported.\nAuthors' conclusions\nWe found insufficient evidence for many treatments of supracondylar fractures. Fixation of displaced supracondylar fractures with retrograde lateral wires compared with crossed wires provided the most substantial body of evidence in this review, and our findings indicate that there may be a lower risk of nerve injury with retrograde lateral wires. In future trials of treatments, we would encourage the adoption of a core outcome set, which includes patient-reported measures. Evaluation of the effectiveness of traction compared with surgical fixation would provide a valuable addition to this clinical field.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 52 studies with 3594 children. Most children were about 5 to 8 years of age and most were boys. The studies were conducted in countries around the world; 33 studies were conducted in countries in South-East Asia. Very few studies reported how they were funded."
}
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query-laysum | 5332 | [
{
"role": "user",
"content": "Abstract: Background\nSeveral school-based interventions are effective in improving child diet and physical activity, and preventing excessive weight gain, and tobacco or harmful alcohol use. However, schools are frequently unsuccessful in implementing such evidence-based interventions.\nObjectives\n1. To evaluate the benefits and harms of strategies aiming to improve school implementation of interventions to address student diet, physical activity, tobacco or alcohol use, and obesity.\n2. To evaluate the benefits and harms of strategies to improve intervention implementation on measures of student diet, physical activity, obesity, tobacco use or alcohol use; describe their cost or cost-effectiveness; and any harms of strategies on schools, school staff or students.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was between 1 September 2016 and 30 April 2021 to identify any relevant trials published since the last published review.\nSelection criteria\nWe defined 'Implementation' as the use of strategies to adopt and integrate evidence-based health interventions and to change practice patterns within specific settings. We included any trial (randomised controlled trial (RCT) or non-randomised controlled trial (non-RCT)) conducted at any scale, with a parallel control group that compared a strategy to implement policies or practices to address diet, physical activity, overweight or obesity, tobacco or alcohol use by students to 'no intervention', 'usual' practice or a different implementation strategy.\nData collection and analysis\nWe used standard Cochrane methods. Given the large number of outcomes reported, we selected and included the effects of a single outcome measure for each trial for the primary (implementation) and secondary (student health behaviour and obesity) outcomes using a decision hierarchy. Where possible, we calculated standardised mean differences (SMDs) to account for variable outcome measures with 95% confidence intervals (CI). For RCTs, we conducted meta-analyses of primary and secondary outcomes using a random-effects model, or in instances where there were between two and five studies, a fixed-effect model. The synthesis of the effects for non-randomised studies followed the 'Synthesis without meta-analysis' (SWiM) guidelines.\nMain results\nWe included an additional 11 trials in this update bringing the total number of included studies in the review to 38. Of these, 22 were conducted in the USA. Twenty-six studies used RCT designs. Seventeen trials tested strategies to implement healthy eating, 12 physical activity and six a combination of risk factors. Just one trial sought to increase the implementation of interventions to delay initiation or reduce the consumption of alcohol. All trials used multiple implementation strategies, the most common being educational materials, educational outreach and educational meetings.\nThe overall certainty of evidence was low and ranged from very low to moderate for secondary review outcomes.\nPooled analyses of RCTs found, relative to a control, the use of implementation strategies may result in a large increase in the implementation of interventions in schools (SMD 1.04, 95% CI 0.74 to 1.34; 22 RCTs, 1917 participants; low-certainty evidence). For secondary outcomes we found, relative to control, the use of implementation strategies to support intervention implementation may result in a slight improvement on measures of student diet (SMD 0.08, 95% CI 0.02 to 0.15; 11 RCTs, 16,649 participants; low-certainty evidence) and physical activity (SMD 0.09, 95% CI −0.02 to 0.19; 9 RCTs, 16,389 participants; low-certainty evidence). The effects on obesity probably suggest little to no difference (SMD −0.02, 95% CI −0.05 to 0.02; 8 RCTs, 18,618 participants; moderate-certainty evidence). The effects on tobacco use are very uncertain (SMD −0.03, 95% CIs −0.23 to 0.18; 3 RCTs, 3635 participants; very low-certainty evidence). One RCT assessed measures of student alcohol use and found strategies to support implementation may result in a slight increase in use (odds ratio 1.10, 95% CI 0.77 to 1.56; P = 0.60; 2105 participants). Few trials reported the economic evaluations of implementation strategies, the methods of which were heterogeneous and evidence graded as very uncertain. A lack of consistent terminology describing implementation strategies was an important limitation of the review.\nAuthors' conclusions\nThe use of implementation strategies may result in large increases in implementation of interventions, and slight improvements in measures of student diet, and physical activity. Further research is required to assess the impact of implementation strategies on such behavioural- and obesity-related outcomes, including on measures of alcohol use, where the findings of one trial suggest it may slightly increase student risk. Given the low certainty of the available evidence for most measures further research is required to guide efforts to facilitate the translation of evidence into practice in this setting.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out how effective strategies were in supporting the implementation of school-based interventions to address student diet, physical activity, unhealthy weight gain, and tobacco or alcohol use. We wanted to know if they were cost-effective and if they had any adverse effects. Examples of strategies include methods of improving quality, education and training, feedback on how the school was doing, prompts and reminders, and educational resources (e.g. manuals)."
}
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query-laysum | 5333 | [
{
"role": "user",
"content": "Abstract: Background\nNew minimal invasive surgeries have been suggested as alternative options to transurethral resection of the prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Convective radiofrequency water vapour thermal therapy is a new technology that uses targeted, controlled water vapour energy (steam) to create necrotic tissue in the prostate.\nObjectives\nTo assess the effects of convective radiofrequency water vapour thermal therapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.\nSearch methods\nWe performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Latin American and the Caribbean Health Sciences Literature, Scopus, Web of Science), trials registries, other sources of grey literature, and conference proceedings published up to 18 February 2020, with no restriction on the language or status of publication.\nSelection criteria\nWe included parallel-group randomised controlled trials (RCTs), cluster-RCTs, and non-randomised observational prospective studies with concurrent comparison groups, in which men with BPH underwent convective radiofrequency water vapour thermal therapy, another active therapy, or a sham procedure.\nData collection and analysis\nTwo review authors independently screened the literature, extracted data, and assessed risk of bias. We had planned to perform statistical analyses using a random-effects model, and interpret them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the certainty of the evidence according to the GRADE approach.\nMain results\nWe included a single, industry-sponsored RCT, with 197 randomised men, that compared convective radiofrequency water vapour thermal therapy to a sham procedure. The mean age 62.9 years, the International Prostate Symptom Score (IPSS) was 21.97, and the mean prostate volume was 45.4 mL. We only found short-term data, measured up to three months.\nPrimary outcomes\nConvective radiofrequency water vapour thermal therapy may improve urologic symptom scores more than a sham procedure, measured on a IPSS scale (0 to 35; higher score represents worse urological symptoms) by a mean difference (MD) of -6.9 (95% confidence interval (CI) -9.06 to -4.74; 195 men; low-certainty evidence), and likely improves quality of life (QoL), measured on a IPSS-QoL scale (0 to 6; higher score represents worse QoL), by a MD of -1.2 (95% CI -1.66 to -0.74; 195 men; moderate-certainty evidence). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on major adverse events (risk ratio (RR) 6.79, 95% CI 0.39 to 117.00; 197 men; very low-certainty evidence) assessed by the Clavien-Dindo classification system of III, IV, and V complications.\nSecondary outcomes\nWe are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on retreatment (RR 1.36, 95% CI 0.06 to 32.86; 197 men; very low-certainty evidence). Convective radiofrequency water vapour thermal therapy may have little to no effect on erectile function (MD 0.4, 95% CI -1.91 to 2.71; 130 men; low-certainty evidence) and ejaculatory function (MD 0.5, 95% CI -0.83 to 1.83; 130 men; low-certainty evidence). Convective radiofrequency water vapour thermal therapy may increase minor adverse events assessed by the Clavien-Dindo classification system of Grade I and II complications (RR 1.89, 95% CI 1.15 to 3.11; 197 men; low-certainty evidence). This would correspond to 434 minor adverse events per 1000 men (95% CI 264 more to 714 more). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on acute urinary retention (RR 4.98, 95% CI 0.28 to 86.63; 197 men; very low-certainty evidence). It likely greatly increases the rate of men requiring indwelling urinary catheters (RR 35.58, 95% CI 15.37 to 82.36; 197 men; moderate-certainty evidence).\nWe were unable to perform any of the predefined secondary analyses.\nWe found no evidence for other comparisons, such as convective radiofrequency water vapour thermal therapy versus TURP or other minimal invasive procedures.\nAuthors' conclusions\nCompared to a sham procedure, urologic symptom scores and quality of life appear to improve with convective radiofrequency water vapour thermal therapy, but we are very uncertain about major adverse events. The certainty of evidence ranged from moderate to very low, with study limitations and imprecision being the most common reasons for rating down. These findings are based on a single industry-sponsored study, with three-month short-term follow-up. We did not find any studies comparing convective radiofrequency water vapour thermal therapy to any other active treatment form, such as TURP.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Compared to a sham procedure, and with a three-month follow-up, convective radiofrequency water vapour thermal therapy may improve urinary symptoms (low certainty of evidence). Convective radiofrequency water vapour thermal therapy also likely improves quality of life (moderate certainty of evidence). We are very uncertain whether serious unwanted side effects are more common or not (very low certainty of evidence). Men's erections and ejaculations may be similar in men who have convective radiofrequency water vapour thermal therapy and those who receive the sham procedure (low certainty of evidence).\nFindings of this review are up to date until 18 February 2020."
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query-laysum | 5334 | [
{
"role": "user",
"content": "Abstract: Background\nAtopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs).\nObjectives\nTo assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments.\nSearch methods\nWe searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database). We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials. We contacted specialists in the field for unpublished data.\nA separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013. We also scrutinised the U.S. Food and Drug Administration (FDA) websites for adverse effects information.\nSelection criteria\nAll randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments.\nData collection and analysis\nTwo authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction. Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects. Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as SCORAD (SCORing Atopic Dermatitis), the EASI (Eczema Area and Severity Index), and BSA (Body Surface Area) scores.\nMain results\nWe included 20 studies, with 5885 participants. The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses.\nA single trial showed that tacrolimus 0.1% was better than low-potency TCS by the physician's assessment (risk ratio (RR) 3.09, 95% confidence interval (CI) 2.14 to 4.45, 1 study, n = 371, moderate-quality evidence). It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 1.32, 95% CI 1.17 to 1.49, 1 study, n = 972, moderate level of evidence) and for some of the secondary outcomes. Compared with pimecrolimus 1%, people treated with tacrolimus were almost twice as likely to improve by the physician's assessment (RR 1.80, 95% CI 1.34 to 2.42, 2 studies, n = 506, moderate quality of evidence). Compared with the lower concentration of 0.03%, the tacrolimus 0.1% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 0.82, 95% CI 0.72 to 0.92, 6 studies, n = 1640, high-quality evidence). Tacrolimus 0.1% compared with moderate-to-potent TCS showed no difference by the physician's assessment, and 2 secondary outcomes (1 study, 377 participants) and a marginal benefit favouring tacrolimus 0.1% was found by the participant's assessment (RR 1.21, 95% CI 1.13 to 1.29, 1 study, n = 974, low quality of evidence) and SCORAD.\nBased on data from 2 trials, tacrolimus 0.03% was superior to mild TCS for the physician's assessment (RR 2.58, 95% CI 1.96 to 3.38, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 1.64, 95% CI 1.41 to 1.90, 1 study, n = 416, moderate quality of evidence). One trial showed moderate benefit of tacrolimus 0.03% compared with pimecrolimus 1% on the physician's assessment (RR 1.42, 95% CI 1.02 to 1.98, 1 study, n = 139, low-quality evidence), but the effects were equivocal when evaluating BSA. In the comparison of tacrolimus 0.03% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes), but in two studies, a marginal benefit favouring the corticosteroid group was found for the EASI and BSA scores.\nBurning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 0.03% (RR 2.48, 95% CI 1.96 to 3.14, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections. Symptoms observed were mild and transient. The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects.\nSerious adverse events were rare; occurred in both the tacrolimus and corticosteroid groups; and in most cases, were considered to be unrelated to the treatment. No cases of lymphoma were noted in the included studies nor in the non-comparative studies. Cases were only noted in spontaneous reports, cohorts, and case-control studies. Systemic absorption was rarely detectable, only in low levels, and this decreased with time. Exception is made for diseases with severe barrier defects, such as Netherton's syndrome, lamellar ichthyosis, and a few others, with case reports of a higher absorption. We evaluated clinical trials; case reports; and in vivo, in vitro, and animal studies; and didn't find any evidence that topical tacrolimus could cause skin atrophy.\nAuthors' conclusions\nTacrolimus 0.1% was better than low-potency corticosteroids, pimecrolimus 1%, and tacrolimus 0.03%. Results were equivocal when comparing both dose formulations to moderate-to-potent corticosteroids. Tacrolimus 0.03% was superior to mild corticosteroids and pimecrolimus. Both tacrolimus formulations seemed to be safe, and no evidence was found to support the possible increased risk of malignancies or skin atrophy with their use. The reliability and strength of the evidence was limited by the lack of data; thus, findings of this review should be interpreted with caution. We did not evaluate costs.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 20 studies, with 5885 participants, in this review. We searched for studies until June 2015. We were interested in the physicians' assessment of improvement, the participants' self-assessment, and any adverse effects. Other outcomes were by objective measures of improvement, such as SCORAD (SCORing Atopic Dermatitis, a tool for measuring atopic dermatitis severity) and the affected body surface area."
}
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query-laysum | 5335 | [
{
"role": "user",
"content": "Abstract: Background\nThe current paradigm for cardiovascular disease (CVD) emphasises absolute risk assessment to guide treatment decisions in primary prevention. Although the derivation and validation of multivariable risk assessment tools, or CVD risk scores, have attracted considerable attention, their effect on clinical outcomes is uncertain.\nObjectives\nTo assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes, risk factor levels, preventive medication prescribing, and health behaviours.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (2016, Issue 2), MEDLINE Ovid (1946 to March week 1 2016), Embase (embase.com) (1974 to 15 March 2016), and Conference Proceedings Citation Index-Science (CPCI-S) (1990 to 15 March 2016). We imposed no language restrictions. We searched clinical trial registers in March 2016 and handsearched reference lists of primary studies to identify additional reports.\nSelection criteria\nWe included randomised and quasi-randomised trials comparing the systematic provision of CVD risk scores by a clinician, healthcare professional, or healthcare system compared with usual care (i.e. no systematic provision of CVD risk scores) in adults without CVD.\nData collection and analysis\nThree review authors independently selected studies, extracted data, and evaluated study quality. We used the Cochrane 'Risk of bias' tool to assess study limitations. The primary outcomes were: CVD events, change in CVD risk factor levels (total cholesterol, systolic blood pressure, and multivariable CVD risk), and adverse events. Secondary outcomes included: lipid-lowering and antihypertensive medication prescribing in higher-risk people. We calculated risk ratios (RR) for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data using 95% confidence intervals. We used a fixed-effects model when heterogeneity (I²) was at least 50% and a random-effects model for substantial heterogeneity (I² > 50%). We evaluated the quality of evidence using the GRADE framework.\nMain results\nWe identified 41 randomised controlled trials (RCTs) involving 194,035 participants from 6422 reports. We assessed studies as having high or unclear risk of bias across multiple domains. Low-quality evidence evidence suggests that providing CVD risk scores may have little or no effect on CVD events compared with usual care (5.4% versus 5.3%; RR 1.01, 95% confidence interval (CI) 0.95 to 1.08; I² = 25%; 3 trials, N = 99,070). Providing CVD risk scores may reduce CVD risk factor levels by a small amount compared with usual care. Providing CVD risk scores reduced total cholesterol (MD −0.10 mmol/L, 95% CI −0.20 to 0.00; I² = 94%; 12 trials, N = 20,437, low-quality evidence), systolic blood pressure (MD −2.77 mmHg, 95% CI −4.16 to −1.38; I² = 93%; 16 trials, N = 32,954, low-quality evidence), and multivariable CVD risk (SMD −0.21, 95% CI −0.39 to −0.02; I² = 94%; 9 trials, N = 9549, low-quality evidence). Providing CVD risk scores may reduce adverse events compared with usual care, but results were imprecise (1.9% versus 2.7%; RR 0.72, 95% CI 0.49 to 1.04; I² = 0%; 4 trials, N = 4630, low-quality evidence). Compared with usual care, providing CVD risk scores may increase new or intensified lipid-lowering medications (15.7% versus 10.7%; RR 1.47, 95% CI 1.15 to 1.87; I² = 40%; 11 trials, N = 14,175, low-quality evidence) and increase new or increased antihypertensive medications (17.2% versus 11.4%; RR 1.51, 95% CI 1.08 to 2.11; I² = 53%; 8 trials, N = 13,255, low-quality evidence).\nAuthors' conclusions\nThere is uncertainty whether current strategies for providing CVD risk scores affect CVD events. Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm. There were multiple study limitations in the identified studies and substantial heterogeneity in the interventions, outcomes, and analyses, so readers should interpret results with caution. New models for implementing and evaluating CVD risk scores in adequately powered studies are needed to define the role of applying CVD risk scores in primary CVD prevention.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What is the evidence about the potential clinical benefits and harms of providing cardiovascular disease (CVD) risk scores in people without a history of heart disease or stroke?"
}
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query-laysum | 5336 | [
{
"role": "user",
"content": "Abstract: Background\nFalls and fall-related injuries are common, particularly in those aged over 65, with around one-third of older people living in the community falling at least once a year. Falls prevention interventions may comprise single component interventions (e.g. exercise), or involve combinations of two or more different types of intervention (e.g. exercise and medication review). Their delivery can broadly be divided into two main groups: 1) multifactorial interventions where component interventions differ based on individual assessment of risk; or 2) multiple component interventions where the same component interventions are provided to all people.\nObjectives\nTo assess the effects (benefits and harms) of multifactorial interventions and multiple component interventions for preventing falls in older people living in the community.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature, trial registers and reference lists. Date of search: 12 June 2017.\nSelection criteria\nRandomised controlled trials, individual or cluster, that evaluated the effects of multifactorial and multiple component interventions on falls in older people living in the community, compared with control (i.e. usual care (no change in usual activities) or attention control (social visits)) or exercise as a single intervention.\nData collection and analysis\nTwo review authors independently selected studies, assessed risks of bias and extracted data. We calculated the rate ratio (RaR) with 95% confidence intervals (CIs) for rate of falls. For dichotomous outcomes we used risk ratios (RRs) and 95% CIs. For continuous outcomes, we used the standardised mean difference (SMD) with 95% CIs. We pooled data using the random-effects model. We used the GRADE approach to assess the quality of the evidence.\nMain results\nWe included 62 trials involving 19,935 older people living in the community. The median trial size was 248 participants. Most trials included more women than men. The mean ages in trials ranged from 62 to 85 years (median 77 years). Most trials (43 trials) reported follow-up of 12 months or over. We assessed most trials at unclear or high risk of bias in one or more domains.\nForty-four trials assessed multifactorial interventions and 18 assessed multiple component interventions. (I2 not reported if = 0%).\nMultifactorial interventions versus usual care or attention control\nThis comparison was made in 43 trials. Commonly-applied or recommended interventions after assessment of each participant's risk profile were exercise, environment or assistive technologies, medication review and psychological interventions. Multifactorial interventions may reduce the rate of falls compared with control: rate ratio (RaR) 0.77, 95% CI 0.67 to 0.87; 19 trials; 5853 participants; I2 = 88%; low-quality evidence. Thus if 1000 people were followed over one year, the number of falls may be 1784 (95% CI 1553 to 2016) after multifactorial intervention versus 2317 after usual care or attention control. There was low-quality evidence of little or no difference in the risks of: falling (i.e. people sustaining one or more fall) (RR 0.96, 95% CI 0.90 to 1.03; 29 trials; 9637 participants; I2 = 60%); recurrent falls (RR 0.87, 95% CI 0.74 to 1.03; 12 trials; 3368 participants; I2 = 53%); fall-related hospital admission (RR 1.00, 95% CI 0.92 to 1.07; 15 trials; 5227 participants); requiring medical attention (RR 0.91, 95% CI 0.75 to 1.10; 8 trials; 3078 participants). There is low-quality evidence that multifactorial interventions may reduce the risk of fall-related fractures (RR 0.73, 95% CI 0.53 to 1.01; 9 trials; 2850 participants) and may slightly improve health-related quality of life but not noticeably (SMD 0.19, 95% CI 0.03 to 0.35; 9 trials; 2373 participants; I2 = 70%). Of three trials reporting on adverse events, one found none, and two reported 12 participants with self-limiting musculoskeletal symptoms in total.\nMultifactorial interventions versus exercise\nVery low-quality evidence from one small trial of 51 recently-discharged orthopaedic patients means that we are uncertain of the effects on rate of falls or risk of falling of multifactorial interventions versus exercise alone. Other fall-related outcomes were not assessed.\nMultiple component interventions versus usual care or attention control\nThe 17 trials that make this comparison usually included exercise and another component, commonly education or home-hazard assessment. There is moderate-quality evidence that multiple interventions probably reduce the rate of falls (RaR 0.74, 95% CI 0.60 to 0.91; 6 trials; 1085 participants; I2 = 45%) and risk of falls (RR 0.82, 95% CI 0.74 to 0.90; 11 trials; 1980 participants). There is low-quality evidence that multiple interventions may reduce the risk of recurrent falls, although a small increase cannot be ruled out (RR 0.81, 95% CI 0.63 to 1.05; 4 trials; 662 participants). Very low-quality evidence means that we are uncertain of the effects of multiple component interventions on the risk of fall-related fractures (2 trials) or fall-related hospital admission (1 trial). There is low-quality evidence that multiple interventions may have little or no effect on the risk of requiring medical attention (RR 0.95, 95% CI 0.67 to 1.35; 1 trial; 291 participants); conversely they may slightly improve health-related quality of life (SMD 0.77, 95% CI 0.16 to 1.39; 4 trials; 391 participants; I2 = 88%). Of seven trials reporting on adverse events, five found none, and six minor adverse events were reported in two.\nMultiple component interventions versus exercise\nThis comparison was tested in five trials. There is low-quality evidence of little or no difference between the two interventions in rate of falls (1 trial) and risk of falling (RR 0.93, 95% CI 0.78 to 1.10; 3 trials; 863 participants) and very low-quality evidence, meaning we are uncertain of the effects on hospital admission (1 trial). One trial reported two cases of minor joint pain. Other falls outcomes were not reported.\nAuthors' conclusions\nMultifactorial interventions may reduce the rate of falls compared with usual care or attention control. However, there may be little or no effect on other fall-related outcomes. Multiple component interventions, usually including exercise, may reduce the rate of falls and risk of falling compared with usual care or attention control.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 43 trials that compared a multifactorial intervention with an inactive control. Multifactorial interventions led to some reduction in the rate at which people fall compared with the inactive control group, but the quality of evidence was low because of large differences in how studies were conducted. There may be little or no difference in the number of people who experienced one or more falls (fallers), recurrent falls, fall-related fractures, or experienced a fall requiring hospital admission or medical attention. Multifactorial interventions may make little difference to people's health-related quality of life. There was very limited evidence on adverse events related to the intervention; all 12 reported musculoskeletal complaints such as back pain were minor.\nWe did not find enough evidence to determine the effects of multifactorial interventions compared with exercise as this was only assessed in one small trial.\nWe identified 18 trials assessing the effects of multiple component interventions. Seventeen compared the intervention with an inactive control group and five compared the intervention with exercise. Seventeen of the trials included exercise in the intervention and another component, often education on falls prevention or home safety assessment. There was limited evidence on adverse events related to the intervention; all six reported events were minor.\nMultiple component interventions probably reduce the rate at which people fall and the number of fallers compared with the inactive control group. They may also reduce the number of people who experienced recurrent falls. The evidence was not enough to determine their effects on fall-related fractures or hospital admission. Multiple component interventions may make little or no difference to the risk of a fall requiring medical attention. However, they may slightly improve a person's health-related quality of life.\nTrials comparing multiple component interventions with exercise showed there may be little or no difference in the rate at which people fall and the number of fallers, but not enough evidence to determine the effects on hospital admission. Other falls outcomes were not reported."
}
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query-laysum | 5337 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 50% of women presenting with subfertility. Subfertility affects 15% to 20% of couples trying to conceive. A significant proportion of these women ultimately need assisted reproductive technology (ART). In vitro fertilisation (IVF) is one of the assisted reproduction techniques employed to raise the chances of achieving a pregnancy. For the standard IVF technique, stimulating follicle development and growth before oocyte retrieval is essential, for which a large number of different methods combining gonadotrophins with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist are used. In women with PCOS, the supra-physiological doses of gonadotrophins used for controlled ovarian hyperstimulation (COH) often result in an exaggerated ovarian response, characterised by the development of a large cohort of follicles of uneven quality, retrieval of immature oocytes, and increased risk of ovarian hyperstimulation syndrome (OHSS). A potentially effective intervention for women with PCOS-related subfertility involves earlier retrieval of immature oocytes at the germinal-vesicle stage followed by in vitro maturation (IVM). So far, the only data available have derived from observational studies and non-randomised clinical trials.\nObjectives\nTo assess the effectiveness and safety of IVM followed by IVF or ICSI versus conventional IVF or ICSI among women with PCOS undergoing assisted reproduction.\nSearch methods\nThis is the second update of this review. We performed the search on 17 April 2018.\nThe search was designed with the help of the Cochrane Gynaecology and Fertility Group Information Specialist, for all published and unpublished randomised controlled trials (RCTs).\nWe searched the the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL via the Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, and the trial registers for ongoing and registered trials and the Open Grey database for grey literature from Europe. We made further searches in the National Institute for Health and Care Excellence (NICE) fertility assessment and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, together with PubMed and Google for any recent trials that have not yet been indexed in the major databases.\nSelection criteria\nAll RCTs on the intention to perform IVM before IVF or ICSI compared with conventional IVF or ICSI for subfertile women with PCOS, irrespective of language and country of origin.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data from studies, and attempted to contact the authors of studies for which data were missing. Our primary outcomes were live birth per woman randomised and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.\nMain results\nWe found two RCTs suitable for inclusion in the review and six ongoing trials that have not yet reported results. Both included studies were published as abstracts in international conferences.\nBoth studies were at unclear or high risk of bias for most of the seven domains assessed. Common problems were unclear reporting of study methods and lack of blinding. The main limitations in the overall quality of the evidence were high risk of bias and serious imprecision.\nThere were no data on the primary outcomes of this review, namely live birth per woman randomised and miscarriage.\nBoth studies reported clinical pregnancy rate: there was evidence of an effect between IVM and IVF, favouring the former (odds ratio 3.10, 95% confidence interval 1.06 to 9.00; 71 participants; 2 studies; I2 = 0%; very low-quality evidence). The incidence of OHSS was zero in both studies in both groups.\nThere were no data for the other outcomes specified in this review.\nAuthors' conclusions\nThough promising data on the in vitro maturation (IVM) technique have been published, unfortunately there is still no evidence from properly conducted randomised controlled trials upon which to base any practice recommendations regarding IVM before in vitro fertilisation (IVF) or intracytoplasmic sperm injection for women with polycystic ovarian syndrome. Regarding our secondary outcomes, very low-quality evidence showed that clinical pregnancy was higher with IVM when compared to IVF, whereas the incidence of ovarian hyperstimulation syndrome was zero in both studies in both groups. We are awaiting the results of six ongoing trials and eagerly anticipate further evidence from good-quality trials in the field.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was very low for all outcomes."
}
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query-laysum | 5338 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin D supplementation during pregnancy may be needed to protect against adverse pregnancy outcomes. This is an update of a review that was first published in 2012 and then in 2016.\nObjectives\nTo examine whether vitamin D supplementation alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register (12 July 2018), contacted relevant organisations (15 May 2018), reference lists of retrieved trials and registries at clinicaltrials.gov and WHO International Clinical Trials Registry Platform (12 July 2018). Abstracts were included if they had enough information to extract the data.\nSelection criteria\nRandomised and quasi-randomised trials evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy in comparison to placebo or no intervention.\nData collection and analysis\nTwo review authors independently i) assessed the eligibility of trials against the inclusion criteria, ii) extracted data from included trials, and iii) assessed the risk of bias of the included trials. The certainty of the evidence was assessed using the GRADE approach.\nMain results\nWe included 30 trials (7033 women), excluded 60 trials, identified six as ongoing/unpublished trials and two trials are awaiting assessments.\nSupplementation with vitamin D alone versus placebo/no intervention\nA total of 22 trials involving 3725 pregnant women were included in this comparison; 19 trials were assessed as having low-to-moderate risk of bias for most domains and three trials were assessed as having high risk of bias for most domains. Supplementation with vitamin D alone during pregnancy probably reduces the risk of pre-eclampsia (risk ratio (RR) 0.48, 95% confidence interval (CI) 0.30 to 0.79; 4 trials, 499 women, moderate-certainty evidence) and gestational diabetes (RR 0.51, 95% CI 0.27 to 0.97; 4 trials, 446 women, moderate-certainty evidence); and probably reduces the risk of having a baby with low birthweight (less than 2500 g) (RR 0.55, 95% CI 0.35 to 0.87; 5 trials, 697 women, moderate-certainty evidence) compared to women who received placebo or no intervention. Vitamin D supplementation may make little or no difference in the risk of having a preterm birth < 37 weeks compared to no intervention or placebo (RR 0.66, 95% CI 0.34 to 1.30; 7 trials, 1640 women, low-certainty evidence). In terms of maternal adverse events, vitamin D supplementation may reduce the risk of severe postpartum haemorrhage (RR 0.68, 95% CI 0.51 to 0.91; 1 trial, 1134 women, low-certainty evidence). There were no cases of hypercalcaemia (1 trial, 1134 women, low-certainty evidence), and we are very uncertain as to whether vitamin D increases or decreases the risk of nephritic syndrome (RR 0.17, 95% CI 0.01 to 4.06; 1 trial, 135 women, very low-certainty evidence). However, given the scarcity of data in general for maternal adverse events, no firm conclusions can be drawn.\nSupplementation with vitamin D and calcium versus placebo/no intervention\nNine trials involving 1916 pregnant women were included in this comparison; three trials were assessed as having low risk of bias for allocation and blinding, four trials were assessed as having high risk of bias and two had some components having a low risk, high risk, or unclear risk. Supplementation with vitamin D and calcium during pregnancy probably reduces the risk of pre-eclampsia (RR 0.50, 95% CI 0.32 to 0.78; 4 trials, 1174 women, moderate-certainty evidence). The effect of the intervention is uncertain on gestational diabetes (RR 0.33,% CI 0.01 to 7.84; 1 trial, 54 women, very low-certainty evidence); and low birthweight (less than 2500 g) (RR 0.68, 95% CI 0.10 to 4.55; 2 trials, 110 women, very low-certainty evidence) compared to women who received placebo or no intervention. Supplementation with vitamin D and calcium during pregnancy may increase the risk of preterm birth < 37 weeks in comparison to women who received placebo or no intervention (RR 1.52, 95% CI 1.01 to 2.28; 5 trials, 942 women, low-certainty evidence). No trial in this comparison reported on maternal adverse events.\nSupplementation with vitamin D + calcium + other vitamins and minerals versus calcium + other vitamins and minerals (but no vitamin D)\nOne trial in 1300 participants was included in this comparison; it was assessed as having low risk of bias. Pre-eclampsia was not assessed. Supplementation with vitamin D + other nutrients may make little or no difference in the risk of preterm birth < 37 weeks (RR 1.04, 95% CI 0.68 to 1.59; 1 trial, 1298 women, low-certainty evidence); or low birthweight (less than 2500 g) (RR 1.12, 95% CI 0.82 to 1.51; 1 trial, 1298 women, low-certainty evidence). It is unclear whether it makes any difference to the risk of gestational diabetes (RR 0.42, 95% CI 0.10 to 1.73) or maternal adverse events (hypercalcaemia no events; hypercalciuria RR 0.25, 95% CI 0.02 to 3.97; 1 trial, 1298 women,) because the certainty of the evidence for both outcomes was found to be very low.\nAuthors' conclusions\nWe included 30 trials (7033 women) across three separate comparisons. Our GRADE assessments ranged from moderate to very low, with downgrading decisions based on limitations in study design, imprecision and indirectness.\nSupplementing pregnant women with vitamin D alone probably reduces the risk of pre-eclampsia, gestational diabetes, low birthweight and may reduce the risk of severe postpartum haemorrhage. It may make little or no difference in the risk of having a preterm birth < 37 weeks' gestation. Supplementing pregnant women with vitamin D and calcium probably reduces the risk of pre-eclampsia but may increase the risk of preterm births < 37 weeks (these findings warrant further research). Supplementing pregnant women with vitamin D and other nutrients may make little or no difference in the risk of preterm birth < 37 weeks' gestation or low birthweight (less than 2500 g). Additional rigorous high quality and larger randomised trials are required to evaluate the effects of vitamin D supplementation in pregnancy, particularly in relation to the risk of maternal adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for evidence (July 2018) and found 30 trials (involving 7033 women) for inclusion in this update.\nEvidence from 22 trials involving 3725 pregnant women suggest that supplementation with vitamin D alone during pregnancy probably reduces the risk of pre-eclampsia, gestational diabetes, and the risk of having a baby with low birthweight compared to placebo or no intervention and may make little or no difference in the risk of having a preterm birth. It may reduce the risk of maternal adverse events, such as severe postpartum haemorrhage, although it should be noted that this result was unexpected and based on a single trial.\nEvidence from nine trials involving 1916 pregnant women suggest that supplementation with vitamin D and calcium probably reduces the risk for pre-eclampsia but may increase the risk of preterm birth. This slight potential harm warrants consideration in women receiving calcium supplementation as part of antenatal care.\nEvidence from one study involving 1300 pregnant women suggest that supplementation with vitamin D plus other nutrients may make little or no difference in the risk of most outcomes evaluated.\nData on maternal adverse events were lacking in most trials."
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query-laysum | 5339 | [
{
"role": "user",
"content": "Abstract: Background\nDornase alfa is currently used as a mucolytic to treat pulmonary disease (the major cause of morbidity and mortality) in cystic fibrosis. It reduces mucus viscosity in the lungs, promoting improved clearance of secretions. This is an update of a previously published review.\nObjectives\nTo determine whether the use of dornase alfa in cystic fibrosis is associated with improved mortality and morbidity compared to placebo or other medications that improve airway clearance, and to identify any adverse events associated with its use.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstracts from conferences. Date of the most recent search of the Group's Cystic Fibrosis Register: 12 October 2020.\nClinicaltrials.gov and the International Clinical Trials Registry Platform were also searched to identify unpublished or ongoing trials. Date of most recent search: 08 February 2021.\nSelection criteria\nAll randomised and quasi-randomised controlled trials comparing dornase alfa to placebo, standard therapy or other medications that improve airway clearance.\nData collection and analysis\nAuthors independently assessed trials against the inclusion criteria; two authors carried out analysis of methodological quality and data extraction. GRADE was used to assess the level of evidence.\nMain results\nThe searches identified 74 trials, of which 19 (2565 participants) met our inclusion criteria. 15 trials compared dornase alfa to placebo or no dornase alfa (2447 participants); two compared daily dornase to hypertonic saline (32 participants); one compared daily dornase alfa to hypertonic saline and alternate day dornase alfa (48 participants); one compared dornase alfa to mannitol and the combination of both drugs (38 participants). Trial duration varied from six days to three years.\nDornase alfa compared to placebo or no treatment\nDornase alfa probably improved forced expiratory volume at one second (FEV1) at one month (four trials, 248 participants), three months (one trial, 320 participants; moderate-quality evidence), six months (one trial, 647 participants; high-quality evidence) and two years (one trial, 410 participants). Limited low-quality evidence showed treatment may make little or no difference in quality of life. Dornase alfa probably reduced the number of pulmonary exacerbations in trials of up to two years (moderate-quality evidence). One trial that examined the cost of care, including the cost of dornase alfa, found that the cost savings from dornase alfa offset 18% to 38% of the medication costs.\nDornase alfa: daily versus alternate day\nOne cross-over trial (43 children) found little or no difference between treatment regimens for lung function, quality of life or pulmonary exacerbations (low-quality evidence).\nDornase alfa compared to other medications that improve airway clearance\nResults for these comparisons were mixed. One trial (43 children) showed dornase alfa may lead to a greater improvement in FEV1 compared to hypertonic saline (low-quality evidence), and one trial (23 participants) reported little or no differences in lung function between dornase alfa and mannitol or dornase alfa and dornase alfa plus mannitol (low-quality evidence). One trial (23 participants) found dornase alfa may improve quality of life compared to dornase alfa plus mannitol (low-quality evidence); other comparisons found little or no difference in this outcome (low-quality evidence). No trials in any comparison reported any difference between groups in the number of pulmonary exacerbations (low-quality evidence).\nWhen all comparisons are assessed, dornase alfa did not cause significantly more adverse effects than other treatments, except voice alteration and rash.\nAuthors' conclusions\nThere is evidence to show that, compared with placebo, therapy with dornase alfa may improve lung function in people with cystic fibrosis in trials lasting from one month to two years. There was a decrease in pulmonary exacerbations in trials of six months or longer, probably due to treatment. Voice alteration and rash appear to be the only adverse events reported with increased frequency in randomised controlled trials. There is not enough evidence to firmly conclude if dornase alfa is superior to other hyperosmolar agents in improving lung function.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cystic fibrosis is an inherited condition which affects the movement of salt across cells in the body and affects, for example, the sweat glands, airways, pancreas and male reproductive system. Lung disease is the most common cause of death in people with cystic fibrosis and although the average life expectancy has increased over the last 30 years, it is still only 48.5 years in high-income countries. People with cystic fibrosis develop chronic lung disease because of thick mucus that builds up in the lungs which causes infections and inflammation. Dornase alfa was developed to thin out this mucus, so it is easier for people to cough it up from their lungs; this in turn should decrease the number of infections and amount of inflammation and prevent chronic lung disease."
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query-laysum | 5340 | [
{
"role": "user",
"content": "Abstract: Background\nOn the American continent, cutaneous and mucocutaneous leishmaniasis (CL and MCL) are diseases associated with infection by several species of Leishmania parasites. Pentavalent antimonials remain the first-choice treatment. There are alternative interventions, but reviewing their effectiveness and safety is important as availability is limited. This is an update of a Cochrane Review first published in 2009.\nObjectives\nTo assess the effects of interventions for all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML).\nSearch methods\nWe updated our database searches of the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and CINAHL to August 2019. We searched five trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) assessing either single or combination treatments for ACML in immuno-competent people, diagnosed by clinical presentation and Leishmania infection confirmed by smear, culture, histology, or polymerase chain reaction on a biopsy specimen. The comparators were either no treatment, placebo only, or another active compound.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our key outcomes were the percentage of participants 'cured' at least three months after the end of treatment, adverse effects, and recurrence. We used GRADE to assess evidence certainty for each outcome.\nMain results\nWe included 75 studies (37 were new), totalling 6533 randomised participants with ATL. The studies were mainly conducted in Central and South America at regional hospitals, local healthcare clinics, and research centres. More male participants were included (mean age: roughly 28.9 years (SD: 7.0)). The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana. The most assessed interventions and comparators were non-antimonial systemics (particularly oral miltefosine) and antimonials (particularly meglumine antimoniate (MA), which was also a common intervention), respectively.\nThree studies included moderate-to-severe cases of mucosal leishmaniasis but none included cases with diffuse cutaneous or disseminated CL, considered the severe cutaneous form. Lesions were mainly ulcerative and located in the extremities and limbs. The follow-up (FU) period ranged from 28 days to 7 years. All studies had high or unclear risk of bias in at least one domain (especially performance bias). None of the studies reported the degree of functional or aesthetic impairment, scarring, or quality of life.\nCompared to placebo, at one-year FU, intramuscular (IM) MA given for 20 days to treat L. braziliensis and L. panamensis infections in ACML may increase the likelihood of complete cure (risk ratio (RR) 4.23, 95% confidence interval (CI) 0.84 to 21.38; 2 RCTs, 157 participants; moderate-certainty evidence), but may also make little to no difference, since the 95% CI includes the possibility of both increased and reduced healing (cure rates), and IMMA probably increases severe adverse effects such as myalgias and arthralgias (RR 1.51, 95% CI 1.17 to 1.96; 1 RCT, 134 participants; moderate-certainty evidence). IMMA may make little to no difference to the recurrence risk, but the 95% CI includes the possibility of both increased and reduced risk (RR 1.79, 95% CI 0.17 to 19.26; 1 RCT, 127 participants; low-certainty evidence).\nCompared to placebo, at six-month FU, oral miltefosine given for 28 days to treat L. mexicana, L. panamensis and L. braziliensis infections in American cutaneous leishmaniasis (ACL) probably improves the likelihood of complete cure (RR 2.25, 95% CI 1.42 to 3.38), and probably increases nausea rates (RR 3.96, 95% CI 1.49 to 10.48) and vomiting (RR 6.92, 95% CI 2.68 to 17.86) (moderate-certainty evidence). Oral miltefosine may make little to no difference to the recurrence risk (RR 2.97, 95% CI 0.37 to 23.89; low-certainty evidence), but the 95% CI includes the possibility of both increased and reduced risk (all based on 1 RCT, 133 participants).\nCompared to IMMA, at 6 to 12 months FU, oral miltefosine given for 28 days to treat L. braziliensis, L. panamensis, L. guyanensis and L. amazonensis infections in ACML may make little to no difference to the likelihood of complete cure (RR 1.05, 95% CI 0.90 to 1.23; 7 RCTs, 676 participants; low-certainty evidence). Based on moderate-certainty evidence (3 RCTs, 464 participants), miltefosine probably increases nausea rates (RR 2.45, 95% CI 1.72 to 3.49) and vomiting (RR 4.76, 95% CI 1.82 to 12.46) compared to IMMA. Recurrence risk was not reported.\nFor the rest of the key comparisons, recurrence risk was not reported, and risk of adverse events could not be estimated.\nCompared to IMMA, at 6 to 12 months FU, oral azithromycin given for 20 to 28 days to treat L. braziliensis infections in ACML probably reduces the likelihood of complete cure (RR 0.51, 95% CI 0.34 to 0.76; 2 RCTs, 93 participants; moderate-certainty evidence).\nCompared to intravenous MA (IVMA) and placebo, at 12 month FU, adding topical imiquimod to IVMA, given for 20 days to treat L. braziliensis, L. guyanensis and L. peruviana infections in ACL probably makes little to no difference to the likelihood of complete cure (RR 1.30, 95% CI 0.95 to 1.80; 1 RCT, 80 participants; moderate-certainty evidence).\nCompared to MA, at 6 months FU, one session of local thermotherapy to treat L. panamensis and L. braziliensis infections in ACL reduces the likelihood of complete cure (RR 0.80, 95% CI 0.68 to 0.95; 1 RCT, 292 participants; high-certainty evidence).\nCompared to IMMA and placebo, at 26 weeks FU, adding oral pentoxifylline to IMMA to treat CL (species not stated) probably makes little to no difference to the likelihood of complete cure (RR 0.86, 95% CI 0.63 to 1.18; 1 RCT, 70 participants; moderate-certainty evidence).\nAuthors' conclusions\nEvidence certainty was mostly moderate or low, due to methodological shortcomings, which precluded conclusive results. Overall, both IMMA and oral miltefosine probably result in an increase in cure rates, and nausea and vomiting are probably more common with miltefosine than with IMMA.\nFuture trials should investigate interventions for mucosal leishmaniasis and evaluate recurrence rates of cutaneous leishmaniasis and its progression to mucosal disease.\n\nGiven the provided abstract, please respond to the following query: \"How we identified and assessed the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "First, we searched for all relevant studies. We then compared the results, summarised the evidence, and assessed the certainty of the evidence."
}
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query-laysum | 5341 | [
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"role": "user",
"content": "Abstract: Background\nOutpatient care facilities provide a variety of basic healthcare services to individuals who do not require hospitalisation or institutionalisation, and are usually the patient's first contact. The provision of outpatient care contributes to immediate and large gains in health status, and a large portion of total health expenditure goes to outpatient healthcare services. Payment method is one of the most important incentive methods applied by purchasers to guide the performance of outpatient care providers.\nObjectives\nTo assess the impact of different payment methods on the performance of outpatient care facilities and to analyse the differences in impact of payment methods in different settings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), 2016, Issue 3, part of the Cochrane Library (searched 8 March 2016); MEDLINE, OvidSP (searched 8 March 2016); Embase, OvidSP (searched 24 April 2014); PubMed (NCBI) (searched 8 March 2016); Dissertations and Theses Database, ProQuest (searched 8 March 2016); Conference Proceedings Citation Index (ISI Web of Science) (searched 8 March 2016); IDEAS (searched 8 March 2016); EconLit, ProQuest (searched 8 March 2016); POPLINE, K4Health (searched 8 March 2016); China National Knowledge Infrastructure (searched 8 March 2016); Chinese Medicine Premier (searched 8 March 2016); OpenGrey (searched 8 March 2016); ClinicalTrials.gov, US National Institutes of Health (NIH) (searched 8 March 2016); World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 8 March 2016); and the website of the World Bank (searched 8 March 2016).\nIn addition, we searched the reference lists of included studies and carried out a citation search for the included studies via ISI Web of Science to find other potentially relevant studies. We also contacted authors of the main included studies regarding any further published or unpublished work.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies that compared different payment methods for outpatient health facilities. We defined outpatient care facilities in this review as facilities that provide health services to individuals who do not require hospitalisation or institutionalisation. We only included methods used to transfer funds from the purchaser of healthcare services to health facilities (including groups of individual professionals). These include global budgets, line-item budgets, capitation, fee-for-service (fixed and unconstrained), pay for performance, and mixed payment. The primary outcomes were service provision outcomes, patient outcomes, healthcare provider outcomes, costs for providers, and any adverse effects.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the risk of bias. We conducted a structured synthesis. We first categorised the comparisons and outcomes and then described the effects of different types of payment methods on different categories of outcomes. We used a fixed-effect model for meta-analysis within a study if a study included more than one indicator in the same category of outcomes. We used a random-effects model for meta-analysis across studies. If the data for meta-analysis were not available in some studies, we calculated the median and interquartile range. We reported the risk ratio (RR) for dichotomous outcomes and the relative change for continuous outcomes.\nMain results\nWe included 21 studies from Afghanistan, Burundi, China, Democratic Republic of Congo, Rwanda, Tanzania, the United Kingdom, and the United States of health facilities providing primary health care and mental health care. There were three kinds of payment comparisons.\n1) Pay for performance (P4P) combined with some existing payment method (capitation or different kinds of input-based payment) compared to the existing payment method\nWe included 18 studies in this comparison, however we did not include five studies in the effects analysis due to high risk of bias. From the 13 studies, we found that the extra P4P incentives probably slightly improved the health professionals' use of some tests and treatments (adjusted RR median = 1.095, range 1.01 to 1.17; moderate-certainty evidence), and probably led to little or no difference in adherence to quality assurance criteria (adjusted percentage change median = -1.345%, range -8.49% to 5.8%; moderate-certainty evidence). We also found that P4P incentives may have led to little or no difference in patients' utilisation of health services (adjusted RR median = 1.01, range 0.96 to 1.15; low-certainty evidence) and may have led to little or no difference in the control of blood pressure or cholesterol (adjusted RR = 1.01, range 0.98 to 1.04; low-certainty evidence).\n2) Capitation combined with P4P compared to fee-for-service (FFS)\nOne study found that compared with FFS, a capitated budget combined with payment based on providers' performance on antibiotic prescriptions and patient satisfaction probably slightly reduced antibiotic prescriptions in primary health facilities (adjusted RR 0.84, 95% confidence interval 0.74 to 0.96; moderate-certainty evidence).\n3) Capitation compared to FFS\nTwo studies compared capitation to FFS in mental health centres in the United States. Based on these studies, the effects of capitation compared to FFS on the utilisation and costs of services were uncertain (very low-certainty evidence).\nAuthors' conclusions\nOur review found that if policymakers intend to apply P4P incentives to pay health facilities providing outpatient services, this intervention will probably lead to a slight improvement in health professionals' use of tests or treatments, particularly for chronic diseases. However, it may lead to little or no improvement in patients' utilisation of health services or health outcomes. When considering using P4P to improve the performance of health facilities, policymakers should carefully consider each component of their P4P design, including the choice of performance measures, the performance target, payment frequency, if there will be additional funding, whether the payment level is sufficient to change the behaviours of health providers, and whether the payment to facilities will be allocated to individual professionals. Unfortunately, the studies included in this review did not help to inform those considerations.\nWell-designed comparisons of different payment methods for outpatient health facilities in low- and middle-income countries and studies directly comparing different designs (e.g. different payment levels) of the same payment method (e.g. P4P or FFS) are needed.\n\nGiven the provided abstract, please respond to the following query: \"Review aim\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane review was to assess the effect of different payment systems for outpatient care facilities. We collected and analysed all relevant studies to answer this question and included 21 studies."
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query-laysum | 5342 | [
{
"role": "user",
"content": "Abstract: Background\nRecently conducted randomised controlled trials (RCTs) suggest that late commencement of parenteral nutrition (PN) may have clinical benefits in critically ill adults and children. However, there is currently limited evidence regarding the optimal timing of commencement of PN in critically ill term and late preterm infants.\nObjectives\nTo evaluate the benefits and safety of early versus late PN in critically ill term and late preterm infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (5 April 2019), MEDLINE Ovid (1966 to 5 April 2019), Embase Ovid (1980 to 5 April 2019), EMCare (1995 to 5 April 2019) and MEDLINE via PubMed (1966 to 5 April 2019). We searched for ongoing or recently completed clinical trials, and also searched the grey literature and reference lists of relevant publications.\nSelection criteria\nWe included RCTs comparing early versus late initiation of PN in term and late preterm infants. We defined early PN as commencing within 72 hours of admission, and late PN as commencing after 72 hours of admission. Infants born at 37 weeks' gestation or more were defined as term, and infants born between 34 and 36+6 weeks' gestation were defined as late preterm.\nData collection and analysis\nTwo review authors independently selected the trials, extracted the data and assessed the risk of bias. Treatment effects were expressed using risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous data. The quality of the evidence was assessed using the GRADE approach.\nMain results\nTwo RCTs were eligible for inclusion. Data were only available from a subgroup (including 209 term infants) from one RCT in children (aged from birth to 17 years) conducted in Belgium, the Netherlands and Canada. In that RCT, children with medium to high risk of malnutrition were included if a stay of 24 hours or more in the paediatric intensive care unit (PICU) was expected. Early PN and late PN were defined as initiation of PN within 24 hours and after day 7 of admission to PICU, respectively. The risk of bias for the study was considered to be low for five domains and high for two domains.\nThe subgroup of term infants that received late PN had significantly lower risk of in-hospital all-cause mortality (RR 0.35, 95% confidence interval (CI) 0.14 to 0.87; RD -0.10, 95% CI -0.18 to -0.02; number needed to treat for an additional beneficial outcome (NNTB) = 10; 1 trial, 209 participants) and neonatal mortality (death from any cause in the first 28 days since birth) (RR 0.29, 95% CI 0.10 to 0.88; RD -0.09, 95% CI -0.16 to -0.01; NNTB = 11; 1 trial, 209 participants).\nThere were no significant differences in rates of healthcare-associated blood stream infections, growth parameters and duration of hospital stay between the two groups. Neurodevelopmental outcomes were not reported. The quality of evidence was considered to be low for all outcomes, due to imprecision (owing to the small sample size and wide confidence intervals) and high risk of bias in the included studies.\nAuthors' conclusions\nWhilst late commencement of PN in term and late preterm infants may have some benefits, the quality of the evidence was low and hence our confidence in the results is limited. Adequately powered RCTs, which evaluate short-term as well as long-term neurodevelopmental outcomes, are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "when very unwell term babies and late preterm babies are unable to tolerate milk feeds due to their illness, it is necessary to give nutrition (such as glucose, amino acids and fat) to these babies via an intravenous drip (a tube that is inserted directly into a vein). Recent studies in sick children and adults suggest that it is better to administer only intravenous glucose initially and to delay giving intravenous amino acids and fat by about a week."
}
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query-laysum | 5343 | [
{
"role": "user",
"content": "Abstract: Background\nHypertension is considered to be a serious health problem worldwide. Controlling and lowering blood pressure are of significant benefit to people with hypertension because hypertension is a risk factor for stroke, heart disease, and cardiovascular disease. Roselle, the tropical plant Hibiscus sabdariffa, also commonly called sour tea or red tea, has been used as both a thirst-quenching drink and for medicinal purposes.\nObjectives\nTo assess the effect of Roselle on blood pressure in people with primary hypertension.\nSearch methods\nFor this update, the Cochrane Hypertension Information Specialist searched the following databases and trials registers for randomised controlled trials (RCTs): the Cochrane Hypertension Specialised Register (to 6 August 2021), Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 7), MEDLINE Ovid (1946 to 5 August 2021), Embase Ovid (1974 to 5 August 2021), ProQuest Dissertations & Theses (to 6 August 2021), Web of Science Clarivate (to 7 August 2021), Food Science and Technology Abstracts Clarivate (to 7 August 2021), the WHO International Clinical Trials Registry Platform (to 6 August 2021), and the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (to 6 August 2021). We searched Google Scholar and OpenSIGLE. We also handsearched local and regional Chinese databases: CBM, CMCC, TCMLARS, CNKI, CMAC, and the Index to Chinese Periodical Literature (to 14 September 2020), as well as Thai databases (ThaiJO, CUIR, TDC, CMU e-Theses, TCTR) (to 3 October 2020). There were no language or publication date restrictions.\nSelection criteria\nWe sought RCTs evaluating the use of any forms of Roselle with placebo or no treatment in adults with hypertension. Our primary outcome was change in trough and/or peak systolic and diastolic blood pressure (SBP, DBP). Secondary outcomes were withdrawals due to adverse effects, change in pulse pressure, and change in heart rate.\nData collection and analysis\nAll search results were managed using Covidence and re-checked for the number of records, inclusion and exclusion of studies with Mendeley reference management software. We used standard methodological procedures expected by Cochrane. Two review authors worked independently in parallel for screening (titles and abstracts, and full reports), data extraction, risk of bias assessment, and assessment of the certainty of the evidence using the GRADE approach. Any disagreements were resolved by discussion or by consultation with the third review author if necessary. We presented mean difference (MD) of change in SBP and DBP with their corresponding 95% confidence interval (CI).\nMain results\nFor this update, only one RCT with a parallel-group design involving 60 participants with type 2 diabetes mellitus fulfilled the inclusion criteria. This study investigated the effect of Roselle extract capsules (total dose of 5600 mg) compared with placebo (lactose) at eight weeks. The study was at low risk of selection bias, performance bias, and detection bias. Conversely, it was at high risk of attrition bias, reporting bias, and other bias (baseline imbalance).\nWe have very little confidence in the effect estimate of Roselle on change-from-baseline in both SBP and DBP between the two groups. The MD of change in SBP was 1.65, 95% CI −7.89 to 11.19 mmHg, 52 participants, very low-certainty evidence. The MD of change in DBP was 4.60, 95% CI −1.38 to 10.58 mmHg, 52 participants, very low-certainty evidence. Our secondary outcomes of withdrawals due to adverse effects, change in pulse pressure, and change in heart rate were not reported. Due to the limited available data, no secondary analyses were performed (subgroup and sensitivity analysis).\nAuthors' conclusions\nThe evidence is currently insufficient to determine the effectiveness of Roselle compared to placebo for controlling or lowering blood pressure in people with hypertension. The certainty of evidence was very low due to methodological limitations, imprecision, and indirectness. There is a need for rigorous RCTs that address the review question.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included one study with 60 participants with type 2 diabetes and hypertension. Participants consumed either a capsule of pure Roselle extract or a placebo containing lactose for eight weeks. We are not sure if Roselle has an effect on blood pressure and the study did not report on the safety of Roselle or on changes to heart rate."
}
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query-laysum | 5344 | [
{
"role": "user",
"content": "Abstract: Background\nPost-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the treatment of PTS. This is the second update of the review first published in 2013.\nObjectives\nTo determine the effectiveness (improvement or deterioration in symptoms) and safety of rutosides for treatment of post-thrombotic syndrome (PTS) in patients with DVT compared to placebo, no intervention, elastic compression stockings (ECS) or any other treatment.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 21 August 2018.\nSelection criteria\nTwo review authors independently assessed studies for inclusion. Studies were included to allow the comparison of rutosides versus placebo or no treatment, rutosides versus ECS, and rutosides versus any other treatment. Two review authors extracted information from the trials. Disagreements were resolved by discussion.\nData collection and analysis\nData were extracted using designated data extraction forms. The Cochrane 'Risk of bias' tool was used for all included studies to assist in the assessment of quality. Primary outcome measures were the occurrence of leg ulceration over time (yes or no) and any improvement or deterioration of post-thrombotic syndrome (yes or no). Secondary outcomes included reduction of oedema, pain, recurrence of DVT or pulmonary embolism, compliance with therapy, and adverse effects. All of the outcome measures were analysed using Mantel-Haenzel fixed-effect model odds ratios. The unit of analysis was the number of patients. We used GRADE to assess the quality of the evidence for each outcome.\nMain results\nTen reports of nine studies were identified following searching and three studies with a total of 233 participants met the inclusion criteria. Overall quality of evidence using the GRADE approach was low, predominantly due to the lack of both participant and researcher blinding in the included studies. The quality of the evidence was further limited as only three small studies contributed to the review findings. A subjective scoring system was used to obtain the symptoms of PTS so it was important that the assessors were blinded to the intervention. One study compared rutosides with placebo, one study compared rutosides with ECS and rutosides plus ECS versus ECS alone, and one study compared rutosides with an alternative venoactive remedy. Occurrence of leg ulceration was not reported in any of the included studies. There was no clear evidence to support a difference in PTS improvement between the rutosides or placebo/no treatment groups (OR 1.29, 95% CI 0.69 to 2.41; 164 participants; 2 studies; low-quality evidence); or between the rutosides and ECS groups (OR 0.80, 95% CI 0.31 to 2.03; 80 participants; 1 study ; low-quality evidence). Results from one small study reported less PTS improvement in the rutosides group compared to an alternative venoactive remedy (OR 0.18, 95% CI 0.04 to 0.94; 29 participants; 1 study; low-quality evidence). There was no clear evidence to support a difference in PTS deterioration when comparing rutosides with placebo/no treatment (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); with ECS (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); or an alternative venoactive remedy (OR 0.19, 95% CI 0.01 to 4.24; 29 participants; 1 study). No clear evidence of a difference in adverse effects between the rutosides and placebo/no treatment groups was seen ('mild side effects' reported in 7/41 and 5/42 respectively). In the study comparing rutosides with ECS, 2/80 could not tolerate ECS and 6/80 stopped medication due to side effects. The study comparing rutosides with an alternative venoactive remedy did not comment on side effects\nAuthors' conclusions\nThere was no evidence that rutosides were superior to the use of placebo or ECS. Overall, there is currently limited low-quality evidence that 'venoactive' or 'phlebotonic' remedies such as rutosides reduce symptoms of PTS. Mild side effects were noted in one study. The three studies included in this review provide no evidence to support the use of rutosides in the treatment of PTS.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review aimed to evaluate the existing literature to see if rutosides were useful for treating PTS. We also investigated whether there were any side effects from the treatment. We searched all existing databases for trials relating to the use of rutosides for the treatment of PTS following DVT (current until 21 August 2018). Two review authors independently assessed the trials for inclusion and extracted results in line with our prescribed criteria. We found three suitable trials, with a total of 233 patients, and six unsuitable trials that were not included in the review.\nThe studies were small and undertaken very differently meaning they could not be combined. The studies used different comparisons with rutosides (placebo (inactive product), compression stockings alone or combined with rutosides, or hidrosmina (a venoactive drug, which acts on the vascular system). They also used different doses of rutosides (900 mg/day to 2000 mg/day). We found no clear evidence from any of the trials that treatment with rutosides improved symptoms and signs of PTS; or that there was any difference in side effects. Occurrence of leg ulceration was not reported in any of the included studies."
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query-laysum | 5345 | [
{
"role": "user",
"content": "Abstract: Background\nCentral venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce catheter-related blood stream infection (CRBSI) by decreasing colonisation. However, there may be concerns on the local and systemic adverse effects of these dressings in neonates.\nObjectives\nWe assessed the effectiveness and safety of antimicrobial (antiseptic or antibiotic) dressings in reducing CVC-related infections in newborn infants. Had there been relevant data, we would have evaluated the effects of antimicrobial dressings in different subgroups, including infants who received different types of CVCs, infants who required CVC for different durations, infants with CVCs with and without other antimicrobial modifications, and infants who received an antimicrobial dressing with and without a clearly defined co-intervention.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 9), MEDLINE (PubMed), EMBASE (EBCHOST), CINAHL and references cited in our short-listed articles using keywords and MeSH headings, up to September 2015.\nSelection criteria\nWe included randomised controlled trials that compared an antimicrobial CVC dressing against no dressing or another dressing in newborn infants.\nData collection and analysis\nWe extracted data using the standard methods of the CNRG. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using risk difference (RD) and risk ratio (RR) with 95% confidence intervals (CIs).\nMain results\nOut of 173 articles screened, three studies were included. There were two comparisons: chlorhexidine dressing following alcohol cleansing versus polyurethane dressing following povidone-iodine cleansing (one study); and silver-alginate patch versus control (two studies). A total of 855 infants from level III neonatal intensive care units (NICUs) were evaluated, 705 of whom were from a single study. All studies were at high risk of bias for blinding of care personnel or unclear risk of bias for blinding of outcome assessors. There was moderate-quality evidence for all major outcomes.\nThe single study comparing chlorhexidine dressing/alcohol cleansing against polyurethane dressing/povidone-iodine cleansing showed no significant difference in the risk of CRBSI (RR 1.18, 95% CI 0.53 to 2.65; RD 0.01, 95% CI −0.02 to 0.03; 655 infants, moderate-quality evidence) and sepsis without a source (RR 1.06, 95% CI 0.75 to 1.52; RD 0.01, 95% CI −0.04 to 0.06; 705 infants, moderate-quality evidence). There was a significant reduction in the risk of catheter colonisation favouring chlorhexidine dressing/alcohol cleansing group (RR 0.62, 95% CI 0.45 to 0.86; RD −0.09, 95% CI −0.15 to −0.03; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 33; 655 infants, moderate-quality evidence). However, infants in the chlorhexidine dressing/alcohol cleansing group were significantly more likely to develop contact dermatitis, with 19 infants in the chlorhexidine dressing/alcohol cleansing group having developed contact dermatitis compared to none in the polyurethane dressing/povidone-iodine cleansing group (RR 43.06, 95% CI 2.61 to 710.44; RD 0.06, 95% CI 0.03 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 13 to 33; 705 infants, moderate-quality evidence). The roles of chlorhexidine dressing in the outcomes reported were unclear, as the two assigned groups received different co-interventions in the form of different skin cleansing agents prior to catheter insertion and during each dressing change.\nIn the other comparison, silver-alginate patch versus control, the data for CRBSI were analysed separately in two subgroups as the two included studies reported the outcome using different denominators: one using infants and another using catheters. There were no significant differences between infants who received silver-alginate patch against infants who received standard line dressing in CRBSI, whether expressed as the number of infants (RR 0.50, 95% CI 0.14 to 1.78; RD −0.12, 95% CI −0.33 to 0.09; 1 study, 50 participants, moderate-quality evidence) or as the number of catheters (RR 0.72, 95% CI 0.27 to 1.89; RD −0.05, 95% CI −0.20 to 0.10; 1 study, 118 participants, moderate-quality evidence). There was also no significant difference between the two groups in mortality (RR 0.55, 95% CI 0.15 to 2.05; RD −0.04, 95% CI −0.13 to 0.05; two studies, 150 infants, I² = 0%, moderate-quality evidence). No adverse skin reaction was recorded in either group.\nAuthors' conclusions\nBased on moderate-quality evidence, chlorhexidine dressing/alcohol skin cleansing reduced catheter colonisation, but made no significant difference in major outcomes like sepsis and CRBSI compared to polyurethane dressing/povidone-iodine cleansing. Chlorhexidine dressing/alcohol cleansing posed a substantial risk of contact dermatitis in preterm infants, although it was unclear whether this was contributed mainly by the dressing material or the cleansing agent. While silver-alginate patch appeared safe, evidence is still insufficient for a recommendation in practice. Future research that evaluates antimicrobial dressing should ensure blinding of caregivers and outcome assessors and ensure that all participants receive the same co-interventions, such as the skin cleansing agent. Major outcomes like sepsis, CRBSI and mortality should be assessed in infants of different gestation and birth weight.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We performed a search in multiple medical databases in September 2015."
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query-laysum | 5346 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes mellitus is a metabolic disorder resulting from a defect in insulin secretion, function, or both. Hyperglycaemia in non-critically ill hospitalised people is associated with poor clinical outcomes (infections, prolonged hospital stay, poor wound healing, higher morbidity and mortality). In the hospital setting people diagnosed with diabetes receive insulin therapy as part of their treatment in order to achieve metabolic control. However, insulin therapy can be provided by different strategies (sliding scale insulin (SSI), basal-bolus insulin, and other modalities). Sliding scale insulin is currently the most commonly used method, however there is uncertainty about which strategy provides the best patient outcomes.\nObjectives\nTo assess the effects of SSI for non-critically ill hospitalised adults with diabetes mellitus.\nSearch methods\nWe identified eligible trials by searching MEDLINE, Embase, LILACS, and the Cochrane Library. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov trial registers. The date of the last search for all databases was December 2017. We also examined reference lists of identified randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors.\nSelection criteria\nWe included RCTs comparing SSI with other strategies for glycaemic control in non-critically ill hospitalised adult participants of any sex with diabetes mellitus.\nData collection and analysis\nTwo review authors independently extracted data, assessed trials for risk of bias, and evaluated the overall certainty of evidence utilising the GRADE instrument. We synthesised data using a random-effects model meta-analysis with 95% prediction intervals, if possible, or descriptive analysis, as appropriate.\nMain results\nOf 720 records screened, we included eight trials that randomised 1048 participants with type 2 diabetes (387 SSI participants and 615 participants in comparator groups were available for final analysis). We included non-critically ill medical and surgical adults with the diagnosis of diabetes mellitus. The mean follow-up time was measured by the mean length of hospital stay and ranged between five and 24 days. The mean age of participants was 44.5 years to 71 years.\nOverall, we judged the risk of bias on the trial level as unclear for selection bias, high for outcome-related performance and detection bias with regard to hypoglycaemic episodes, other adverse events, and mean glucose levels, and low for all-cause mortality and length of hospital stay. Attrition bias was low for all outcome measures.\nSix trials compared SSI with a basal-bolus insulin scheme, three of which investigating 64% of all participants in this category also applying an SSI approach in the bolus comparator part. One trial had a basal insulin-only comparator arm, and the remaining trial used continuous insulin infusion as the comparator. For our main comparison of SSI versus basal-bolus insulin, the results were as follows. Four trials reported mortality data. One out of 268 participants in the SSI group (0.3%) compared with two out of 334 participants in the basal-bolus group (0.6%) died (low-certainty evidence). Severe hypoglycaemic episodes, defined as blood glucose levels below 40 mg/dL (2.2 mmol/L), showed a risk ratio (RR) of 0.22, 95% confidence interval (CI) 0.05 to 1.00; P = 0.05; 5 trials; 667 participants; very low-certainty evidence. The 95% prediction interval ranged between 0.02 and 2.57. All nine severe hypoglycaemic episodes were observed among the 369 participants on basal-bolus insulin (2.4%). The mean length of hospital stay was 0.5 days longer for the SSI group, 95% CI -0.5 to 1.4; P = 0.32; 6 trials; 717 participants; very low-certainty evidence. The 95% prediction interval ranged between -1.7 days and 2.7 days. Adverse events other than hypoglycaemic episodes, such as postoperative infections, showed a RR of 1.16, 95% CI 0.25 to 5.37; P = 0.85; 3 trials; 481 participants; very low-certainty evidence. The mean blood glucose levels ranged across basal-bolus groups from 156 mg/dL (8.7 mmol/L) to 221 mg/dL (12.3 mmol/L). The mean blood glucose level in the SSI groups was 14.8 mg/dL (0.8 mmol/L) higher (95% CI 7.8 (0.4) to 21.8 (1.2); P < 0.001; 6 trials; 717 participants; low-certainty evidence). The 95% prediction interval ranged between -3.6 mg/dL (-0.2 mmol/L) and 33.2 mg/dL (1.8 mmol/L). No trial reported on diabetes-related mortality or socioeconomic effects.\nAuthors' conclusions\nWe are uncertain which insulin strategy (SSI or basal-bolus insulin) is best for non-critically hospitalised adults with diabetes mellitus. A basal-bolus insulin strategy in these patients might result in better short-term glycaemic control but could increase the risk for severe hypoglycaemic episodes. The certainty of the body of evidence comparing SSI with basal-bolus insulin was low to very low and needs to be improved by adequately performed, well-powered RCTs in different hospital environments with well-educated medical staff using identical short-acting insulins in both intervention and comparator arms to compare the rigid SSI approach with flexible insulin application strategies.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found eight randomised controlled trials (studies in which participants are assigned to one of two or more treatment groups in a random manner) where 387 people on sliding scale insulin therapy and 615 on mainly basal-bolus insulin treatment with type 2 diabetes could be analysed. The average length of hospital stay was between five and 24 days. Six studies compared sliding scale insulin with basal-bolus insulin; one study compared sliding scale insulin with basal insulin only; and the remaining study used continuous insulin infusion as the control group. The average age of participants was 44.5 years to 71 years.\nThe evidence is up to date as of December 2017."
}
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query-laysum | 5347 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory tract infections with Pseudomonas aeruginosa occur in most people with cystic fibrosis (CF). Established chronic P aeruginosa infection is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate.\nThis is an updated review.\nObjectives\nDoes giving antibiotics for P aeruginosa infection in people with CF at the time of new isolation improve clinical outcomes (e.g. mortality, quality of life and morbidity), eradicate P aeruginosa infection, and delay the onset of chronic infection, but without adverse effects, compared to usual treatment or an alternative antibiotic regimen? We also assessed cost-effectiveness.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and conference proceedings. Latest search: 24 March 2022.\nWe searched ongoing trials registries. Latest search: 6 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of people with CF, in whom P aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous (IV) antibiotics with placebo, usual treatment or other antibiotic combinations. We excluded non-randomised trials and cross-over trials.\nData collection and analysis\nTwo authors independently selected trials, assessed risk of bias and extracted data. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 11 trials (1449 participants) lasting between 28 days and 27 months; some had few participants and most had relatively short follow-up periods. Antibiotics in this review are: oral – ciprofloxacin and azithromycin; inhaled – tobramycin nebuliser solution for inhalation (TNS), aztreonam lysine (AZLI) and colistin; IV – ceftazidime and tobramycin. There was generally a low risk of bias from missing data. In most trials it was difficult to blind participants and clinicians to treatment. Two trials were supported by the manufacturers of the antibiotic used.\nTNS versus placebo\nTNS may improve eradication; fewer participants were still positive for P aeruginosa at one month (odds ratio (OR) 0.06, 95% confidence interval (CI) 0.02 to 0.18; 3 trials, 89 participants; low-certainty evidence) and two months (OR 0.15, 95% CI 0.03 to 0.65; 2 trials, 38 participants). We are uncertain whether the odds of a positive culture decrease at 12 months (OR 0.02, 95% CI 0.00 to 0.67; 1 trial, 12 participants).\nTNS (28 days) versus TNS (56 days)\nOne trial (88 participants) comparing 28 days to 56 days TNS treatment found duration of treatment may make little or no difference in time to next isolation (hazard ratio (HR) 0.81, 95% CI 0.37 to 1.76; low-certainty evidence).\nCycled TNS versus culture-based TNS\nOne trial (304 children, one to 12 years old) compared cycled TNS to culture-based therapy and also ciprofloxacin to placebo. We found moderate-certainty evidence of an effect favouring cycled TNS therapy (OR 0.51, 95% CI 0.31 to 0.82), although the trial publication reported age-adjusted OR and no difference between groups.\nCiprofloxacin versus placebo added to cycled and culture-based TNS therapy\nOne trial (296 participants) examined the effect of adding ciprofloxacin versus placebo to cycled and culture-based TNS therapy. There is probably no difference between ciprofloxacin and placebo in eradicating P aeruginosa (OR 0.89, 95% CI 0.55 to 1.44; moderate-certainty evidence).\nCiprofloxacin and colistin versus TNS\nWe are uncertain whether there is any difference between groups in eradication of P aeruginosa at up to six months (OR 0.43, 95% CI 0.15 to 1.23; 1 trial, 58 participants) or up to 24 months (OR 0.76, 95% CI 0.24 to 2.42; 1 trial, 47 participants); there was a low rate of short-term eradication in both groups.\nCiprofloxacin plus colistin versus ciprofloxacin plus TNS\nOne trial (223 participants) found there may be no difference in positive respiratory cultures at 16 months between ciprofloxacin with colistin versus TNS with ciprofloxacin (OR 1.28, 95% CI 0.72 to 2.29; low-certainty evidence).\nTNS plus azithromycin compared to TNS plus oral placebo\nAdding azithromycin may make no difference to the number of participants eradicating P aeruginosa after a three-month treatment phase (risk ratio (RR) 1.01, 95% CI 0.75 to 1.35; 1 trial, 91 participants; low-certainty evidence); there was also no evidence of any difference in the time to recurrence.\nCiprofloxacin and colistin versus no treatment\nA single trial only reported one of our planned outcomes; there were no adverse effects in either group.\nAZLI for 14 days plus placebo for 14 days compared to AZLI for 28 days\nWe are uncertain whether giving 14 or 28 days of AZLI makes any difference to the proportion of participants having a negative respiratory culture at 28 days (mean difference (MD) -7.50, 95% CI -24.80 to 9.80; 1 trial, 139 participants; very low-certainty evidence).\nCeftazidime with IV tobramycin compared with ciprofloxacin (both regimens in conjunction with three months colistin)\nIV ceftazidime with tobramycin compared with ciprofloxacin may make little or no difference to eradication of P aeruginosa at three months, sustained to 15 months, provided that inhaled antibiotics are also used (RR 0.84, 95 % CI 0.65 to 1.09; P = 0.18; 1 trial, 255 participants; high-certainty evidence). The results do not support using IV antibiotics over oral therapy to eradicate P aeruginosa, based on both eradication rate and financial cost.\nAuthors' conclusions\nWe found that nebulised antibiotics, alone or with oral antibiotics, were better than no treatment for early infection with P aeruginosa. Eradication may be sustained in the short term. There is insufficient evidence to determine whether these antibiotic strategies decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. Four trials comparing two active treatments have failed to show differences in rates of eradication of P aeruginosa. One large trial showed that intravenous ceftazidime with tobramycin is not superior to oral ciprofloxacin when inhaled antibiotics are also used. There is still insufficient evidence to state which antibiotic strategy should be used for the eradication of early P aeruginosa infection in CF, but there is now evidence that intravenous therapy is not superior to oral antibiotics.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to compare different combinations of inhaled, oral and intravenous (IV) antibiotics for clearing P aeruginosa in people with CF, to see if any single treatment works best and is more cost-effective."
}
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query-laysum | 5348 | [
{
"role": "user",
"content": "Abstract: Background\nPortal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including bleeding (haemorrhage) from oesophageal and gastrointestinal varices. Variceal bleeding commonly occurs in children and adolescents with chronic liver disease or portal vein thrombosis. Prevention is, therefore, important. Randomised clinical trials have shown that non-selective beta-blockers and endoscopic variceal band ligation decrease the incidence of variceal bleeding in adults. In children and adolescents, band ligation, beta-blockers, and sclerotherapy have been proposed as primary prophylaxis alternatives for oesophageal variceal bleeding. However, it is unknown whether these interventions are of benefit or harm when used for primary prophylaxis in children and adolescents.\nObjectives\nTo assess the benefits and harms of band ligation compared with sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, PubMed, Embase, and two other databases (April 2020). We scrutinised the reference lists of the retrieved publications, and we also handsearched abstract books of the two main paediatric gastroenterology and hepatology conferences from January 2008 to December 2019. We also searched clinicaltrials.gov, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) for ongoing clinical trials. We imposed no language or document type restrictions on our search.\nSelection criteria\nWe aimed to include randomised clinical trials irrespective of blinding, language, or publication status, to assess the benefits and harms of band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. If the search for randomised clinical trials retrieved quasi-randomised and other observational studies, then we read them through to extract information on harm.\nData collection and analysis\nWe used standard Cochrane methodology to perform this systematic review. We used GRADE to assess the certainty of evidence for each outcome. Our primary outcomes were all-cause mortality, serious adverse events and liver-related morbidity, and quality of life. Our secondary outcomes were oesophageal variceal bleeding and adverse events not considered serious. We used the intention-to-treat principle. We analysed data using Review Manager 5.\nMain results\nOne conference abstract, describing a feasibility multi-centre randomised clinical trial, fulfilled our review inclusion criteria. We judged the trial at overall high risk of bias. This trial was conducted in three hospital centres in the United Kingdom. The aim of the trial was to determine the feasibility and safety of further larger randomised clinical trials of prophylactic band ligation versus no active treatment in children with portal hypertension and large oesophageal varices. Twelve children received prophylactic band ligation and 10 children received no active treatment. There was no information on the age of the children included, or about the diagnosis of any child included. All children were followed up for at least six months. Mortality was 8% (1/12) in the band ligation group versus 0% (0/10) in the no active intervention group (risk ratio (RR) 2.54, 95% confidence interval (CI) 0.11 to 56.25; very low certainty of evidence). The abstract did not report when the death occurred, but we assume it happened between the six-month follow-up and one year. No child (0%) in the band ligation group developed adverse events (RR 0.28, 95% CI 0.01 to 6.25; very low certainty of evidence) but one child out of 10 (10%) in the no active intervention group developed idiopathic thrombocytopaenic purpura. One child out of 12 (8%) in the band ligation group underwent liver transplantation versus none in the no active intervention group (0%) (RR 2.54, 95% CI 0.11 to 56.25; very low certainty of evidence). The trial reported no other serious adverse events or liver-related morbidity. Quality of life was not reported. Oesophageal variceal bleeding occurred in 8% (1/12) of the children in the band ligation group versus 30% (3/10) of the children in the no active intervention group (RR 0.28, 95% CI 0.03 to 2.27; very low certainty of evidence). No adverse events considered non-serious were reported. Two children were lost to follow-up by one-year. Ten children in total completed the trial at two-year follow-up. There was no information on funding.\nWe found two observational studies on endoscopic variceal ligation when searching for randomised trials. One found no harm, and the other reported Enterobactercloacae septicaemia in one child and mild, transient, upper oesophageal sphincter stenosis in another. We did not assess these studies for risk of bias.\nWe did not find any ongoing randomised clinical trials of interest to our review.\nAuthors' conclusions\nThe evidence, obtained from only one feasibility randomised clinical trial at high risk of bias, is very scanty. It is very uncertain about whether prophylactic band ligation versus sham or no (active) intervention may affect mortality, serious adverse events and liver-related morbidity, or oesophageal variceal bleeding in children and adolescents with portal hypertension and large oesophageal varices. We have no data on quality of life. No adverse events considered non-serious were reported. The results presented in the trial need to be interpreted with caution. In addition, the highly limited data cover only part of our research question; namely, children with portal hypertension and large oesophageal varices. Data on children with portal vein thrombosis are lacking.\nLarger randomised clinical trials assessing the benefits and harms of band ligation compared with sham treatment for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis are needed. The trials should include important clinical outcomes such as death, quality of life, failure to control bleeding, and adverse events.\n\nGiven the provided abstract, please respond to the following query: \"How are enlarged veins in the oesophagus treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In adults, studies have shown two treatments work well to treat bleeding from enlarged veins:\n- taking medicines called beta-blockers; and\n- placing an elastic ring around the vein to cut off the blood flow through it.\nThese two treatments have become the main ways to prevent bleeding from enlarged veins in the oesophagus in adults. However, we do not know how well these treatments work in children and young people, or if they cause any unwanted effects or harms."
}
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query-laysum | 5349 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, with an unpredictable course. Current MS therapies such as disease-modifying therapies focus on treating exacerbations, preventing new exacerbations and avoiding the progression of disability. Siponimod (BAF312) is an oral treatment, a selective sphingosine-1-phosphate (S1P) receptor modulator, for the treatment of adults with relapsing forms of MS including active, secondary progressive MS with relapses.\nObjectives\nTo assess the benefits and adverse effects of siponimod as monotherapy or combination therapy versus placebo or any active comparator for people diagnosed with MS.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Trials Register, which contains studies from CENTRAL, MEDLINE and Embase, and the trials registry databases ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 10 September 2021. We also handsearched relevant journals and screened the reference lists of published reviews and retrieved articles and searched reports (2004 to September 2021) from the MS societies in Europe and America.\nSelection criteria\nWe included randomised parallel controlled clinical trials (RCTs) that evaluated siponimod, as monotherapy or combination therapy, versus placebo or any active comparator in people with MS. There were no restrictions on dose or administration frequency.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We discussed disagreements and resolved them by consensus among the review authors. Our primary outcomes wereworsening disability , relapse and adverse events, and secondary outcomes were annualised relapse rate, gadolinium-enhancing lesions, new lesions or enlarged pre-existing lesions and mean change of brain volume. We independently evaluated the certainty of evidence using the GRADE approach. We contacted principal investigators of included studies for additional data or confirmation of data.\nMain results\nTwo studies (1948 participants) met our selection criteria, 608 controls and 1334 treated with siponimod. The included studies compared siponimod with placebo. Overall, all studies had a high risk of bias due to selective reporting and attrition bias.\nComparing siponimod administered at a dose of 2 mg to placebo, we found that siponimod may reduce the number of participants with disability progression at six months (56 fewer people per 1000; risk ratio (RR) 0.78, 95% confidence interval (CI) 0.65 to 0.94; 1 study, 1641 participants; low-certainty evidence) and annualised relapse rate (RR 0.43, 95% CI 0.34 to 0.56; 2 studies, 1739 participants; low-certainty evidence). But it might lead to little reduction in the number of participants with new relapse (166 fewer people per 1000; RR 0.38, 95% CI 0.15 to 1.00; 1 study, 94 participants; very low-certainty evidence). We observed no evidence of a difference due to adverse events for siponimod at 2 mg compared to placebo (14 more people per 1000; RR 1.52, 95% CI 0.85 to 2.71; 2 studies, 1739 participants, low-certainty evidence). In addition, due to the high risk of inaccurate magnetic resonance imaging (MRI) data in the two included studies, we could not combine data for active lesions on MRI scans. Both studies had high attrition bias resulting from the unbalanced reasons for dropouts among groups and high risk of bias due to conflicts of interest. Siponimod may reduce the number of gadolinium-enhancing T1-weighted lesions at two years of follow-up (RR 0.14, 95% CI 0.10 to 0.19; P < 0.0001; 1 study, 1641 participants; very low-certainty evidence). There may be no evidence of a difference between groups in the number of participants with at least one serious adverse event excluding relapses (113 more people per 1000; RR 1.80, 95% CI 0.37 to 8.77; 2 studies, 1739 participants; low-certainty evidence) at six months. No data were available regarding cardiac adverse events.\nIn terms of safety profile, the most common adverse events associated with siponimod were headache, back pain, bradycardia, dizziness, fatigue, influenza, urinary tract infection, lymphopenia, nausea, alanine amino transferase increase and upper respiratory tract infection. These adverse events have dose-related effects and rarely led to discontinuation of treatment.\nAuthors' conclusions\nBased on the findings of the RCTs included in this review, we are uncertain whether siponimod interventions are beneficial for people with MS. There was low-certainty evidence to support that siponimod at a dose of 2 mg orally once daily as monotherapy compared with placebo may reduce the annualised relapse rate and the number of participants who experienced disability worsening, at 6 months. However, the certainty of the evidence to support the benefit in reducing the number of people with a relapse is very low.\nThe risk of withdrawals due to adverse events requires careful monitoring of participants over time. The duration of all studies was less than 24 months, so the efficacy and safety of siponimod over 24 months are still uncertain, and further exploration is needed in the future. There is no high-certainty data available to evaluate the benefit on MRI outcomes. We assessed the certainty of the body of evidence for all outcomes was low to very low, downgraded due to serious study limitations, imprecision and indirectness. We are uncertain whether siponimod is beneficial for people with MS.\nMore new studies with robust methodology and longer follow-up are needed to evaluate the benefit of siponimod for the management of MS and to observe long-term adverse effects. Also, in addition to comparing with placebo, more new studies are needed to evaluate siponimod versus other therapeutic options.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Our confidence in the evidence is limited because we found only 2 studies. They did not provide information about everything we were interested and they included people with different types of MS. Also, they did not last long enough to judge the impact of unwanted effects. Both studies were funded by the company that makes siponimod.\n\n\n\n\n\n\n\n\n"
}
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query-laysum | 5350 | [
{
"role": "user",
"content": "Abstract: Background\nChronic health conditions in children and adolescents can have profound impacts on education, well-being and health. They are described as non-communicable illnesses that are prolonged in duration, do not resolve spontaneously, and rarely cured completely. Due to variations in the definition of chronic health conditions and how they are measured prevalence estimates vary considerably and have been reported to be as high as 44% in children and adolescents. Of young people with a chronic health condition, an estimated 5% are affected by severe conditions characterised by limitations to daily activities impacting their ability to attend school. School attendance is important for academic and social skill development as well as well-being. When children and adolescents are absent from school due to a chronic health condition, school engagement can be affected. Disengagement from school is associated with poorer academic achievement, social-emotional functioning and career choices. Education support services for children and adolescents with chronic health conditions aim to prevent disengagement from school, education and learning during periods where their illness caused them to miss school. However, there is limited evidence on the effectiveness of educational support interventions at improving school engagement and educational/learning outcomes for children and adolescents with chronic health conditions.\nObjectives\nTo describe the nature of educational support interventions for children and adolescents with a chronic health condition, and to examine the effectiveness of these interventions on school engagement and academic achievement.\nSearch methods\nWe searched eight electronic databases which span the health/medical, social sciences and education disciplines between 18 and 25 January 2021: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid). CINAHL (EBSCO), PsycINFO (EBSCO), ERIC (Education Resources Information Center), Applied Social Sciences Index and Abstracts: ASSIA (ProQuest), and PubMed (from 2019). We also searched five grey literature trials registers and databases between 8 and 12 February 2021 to identify additional published and unpublished studies, theses and conference abstracts, as well as snowballing reference lists of included studies.\nSelection criteria\nRandomised controlled trials (RCTs), controlled before-and-after studies and interrupted time series studies that met the inclusion criteria were selected. Other inclusion criteria were: participants - must include children or adolescents (aged four to 18 years) with a chronic health condition, intervention - must include educational support, outcomes - must report the primary outcomes (i.e. school engagement or academic achievement) or secondary outcomes (i.e. quality of life, transition to school/school re-entry, mental health or adverse outcomes).\nData collection and analysis\nTwo people independently screened titles and abstracts, and full-text articles, to identify included studies. Where disagreements arose between reviewers, the two reviewers discussed the discrepancy. If resolution was unable to be achieved, the issues were discussed with a senior reviewer to resolve the matter. We extracted study characteristic data and risk of bias data from the full texts of included studies using a data extraction form before entering the information into Review Manager 5.4.1. Two people independently extracted data, assessed risk of bias of individual studies and undertook GRADE assessments of the quality of the evidence.\nMeta-analysis was not possible due to the small number of studies for each outcome. Our synthesis, therefore, used vote-counting based on the direction of the effect/impact of the intervention.\nMain results\nThe database searches identified 14,202 titles and abstracts. Grey literature and reference list searches did not identify any additional studies that met the inclusion criteria. One hundred and twelve full-text studies were assessed for eligibility, of which four studies met the eligibility criteria for inclusion in the review. All studies were randomised controlled studies with a combined total of 359 participants. All included studies were disease-specific; three studies focused on children with cancer, and one study focused on children with Attention Deficit Hyperactivity Disorder (ADHD).\nThere was evidence that education support improved school engagement with three of four studies favouring the intervention. Three studies measured academic achievement but only two studies provided effect estimates. Based on the vote-counting method, we found contradictory results from the studies: one study showed a positive direction of effect and the other study showed a negative direction of effect. One study measured transition back to school and found a positive impact of education support favouring the intervention (SMD 0.18, 95% CI -0.46 to 0.96, no P value reported). The result came from a single study with a small sample size (n = 30), and produced a confidence interval that indicated the possibility of a very small or no effect. The overall certainty of evidence for these three outcomes was judged to be 'very low'.\nTwo of four studies measured mental health (measured as self-esteem). Both studies reported a positive impact of education support interventions on mental health; this was the only outcome for which the overall certainty of evidence was judged to be 'low' rather than 'very low'.\nNo studies measured or reported quality of life or adverse effects.\nRisk of bias (selection, performance, detection, attrition, reporting and other bias) was assessed using the Cochrane risk of bias tool for randomised trials (version 1). Overall risk of bias for all studies was assessed as 'high risk' because all studies had at least one domain at high risk of bias.\nAuthors' conclusions\nThis review has demonstrated the infancy of quality research on the effectiveness of education support interventions for children and adolescents with chronic health conditions. At best, we can say that we are uncertain whether education support interventions improve either academic achievement or school engagement. Of the secondary outcomes, we are also uncertain whether education support interventions improve transition back to school, or school re-entry. However, we suggest there is some evidence that education support may slightly improve mental health, measured as self-esteem. Given the current state of the evidence of the effectiveness of education support interventions for children and adolescents with chronic health conditions, we highlight some important implications for future research in this field to strengthen the evidence that can inform effective practice and policy.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to describe educational support interventions for children and adolescents with a chronic health condition and find out what effect they had on school engagement and learning outcomes, in particular. We also wanted to see if these services had an effect on mental health and quality of life."
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query-laysum | 5351 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original review published in the Cochrane Database of Systematic Reviews Issue 10, 2015.\nInvasive aspergillosis (IA) is the most common life-threatening opportunistic invasive mould infection in immunocompromised people. Early diagnosis of IA and prompt administration of appropriate antifungal treatment are critical to the survival of people with IA. Antifungal drugs can be given as prophylaxis or empirical therapy, instigated on the basis of a diagnostic strategy (the pre-emptive approach) or for treating established disease. Consequently, there is an urgent need for research into both new diagnostic tools and drug treatment strategies. Increasingly, newer methods such as polymerase chain reaction (PCR) to detect fungal nucleic acids are being investigated.\nObjectives\nTo provide an overall summary of the diagnostic accuracy of PCR-based tests on blood specimens for the diagnosis of IA in immunocompromised people.\nSearch methods\nWe searched MEDLINE (1946 to June 2015) and Embase (1980 to June 2015). We also searched LILACS, DARE, Health Technology Assessment, Web of Science and Scopus to June 2015. We checked the reference lists of all the studies identified by the above methods and contacted relevant authors and researchers in the field. For this review update we updated electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid (June 2015 to March week 2 2018); and Embase via Ovid (June 2015 to 2018 week 12).\nSelection criteria\nWe included studies that: i) compared the results of blood PCR tests with the reference standard published by the European Organisation for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG); ii) reported data on false-positive, true-positive, false-negative and true-negative results of the diagnostic tests under investigation separately; and iii) evaluated the test(s) prospectively in cohorts of people from a relevant clinical population, defined as a group of individuals at high risk for invasive aspergillosis. Case-control and retrospective studies were excluded from the analysis.\nData collection and analysis\nAuthors independently assessed quality and extracted data. For PCR assays, we evaluated the requirement for either one or two consecutive samples to be positive for diagnostic accuracy. We investigated heterogeneity by subgroup analyses. We plotted estimates of sensitivity and specificity from each study in receiver operating characteristics (ROC) space and constructed forest plots for visual examination of variation in test accuracy. We performed meta-analyses using the bivariate model to produce summary estimates of sensitivity and specificity.\nMain results\nWe included 29 primary studies (18 from the original review and 11 from this update), corresponding to 34 data sets, published between 2000 and 2018 in the meta-analyses, with a mean prevalence of proven or probable IA of 16.3 (median prevalence 11.1% , range 2.5% to 57.1%). Most patients had received chemotherapy for haematological malignancy or had undergone hematopoietic stem cell transplantation. Several PCR techniques were used among the included studies. The sensitivity and specificity of PCR for the diagnosis of IA varied according to the interpretative criteria used to define a test as positive. The summary estimates of sensitivity and specificity were 79.2% (95% confidence interval (CI) 71.0 to 85.5) and 79.6% (95% CI 69.9 to 86.6) for a single positive test result, and 59.6% (95% CI 40.7 to 76.0) and 95.1% (95% CI 87.0 to 98.2) for two consecutive positive test results.\nAuthors' conclusions\nPCR shows moderate diagnostic accuracy when used as screening tests for IA in high-risk patient groups. Importantly the sensitivity of the test confers a high negative predictive value (NPV) such that a negative test allows the diagnosis to be excluded. Consecutive positives show good specificity in diagnosis of IA and could be used to trigger radiological and other investigations or for pre-emptive therapy in the absence of specific radiological signs when the clinical suspicion of infection is high. When a single PCR positive test is used as the diagnostic criterion for IA in a population of 100 people with a disease prevalence of 16.3% (overall mean prevalence), three people with IA would be missed (sensitivity 79.2%, 20.8% false negatives), and 17 people would be unnecessarily treated or referred for further tests (specificity of 79.6%, 21.4% false positives). If we use the two positive test requirement in a population with the same disease prevalence, it would mean that nine IA people would be missed (sensitivity 59.6%, 40.4% false negatives) and four people would be unnecessarily treated or referred for further tests (specificity of 95.1%, 4.9% false positives). Like galactomannan, PCR has good NPV for excluding disease, but the low prevalence of disease limits the ability to rule in a diagnosis. As these biomarkers detect different markers of disease, combining them is likely to prove more useful.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We conducted our most recent search for studies in March 2018 and combined with an earlier search selected 29 clinical studies reporting the evaluation of PCR tests prospectively in cohorts of people at high risk of IA."
}
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query-laysum | 5352 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is a common and distressing mental disorder. It is often caused by a combination of stressor events in susceptible people, particularly older people living with frailty and dementia. Adults living in institutional long-term care (LTC) are at particularly high risk of delirium. An episode of delirium increases risks of admission to hospital, development or worsening of dementia and death. Multicomponent interventions can reduce the incidence of delirium by a third in the hospital setting. However, it is currently unclear whether interventions to prevent delirium in LTC are effective. This is an update of a Cochrane Review first published in 2014.\nObjectives\nTo assess the effectiveness of interventions for preventing delirium in older people in institutional long-term care settings.\nSearch methods\nWe searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group (CDCIG) ’s Specialised Register of dementia trials (dementia.cochrane.org/our-trials-register), to 27 February 2019. The search was sufficiently sensitive to identify all studies relating to delirium. We ran additional separate searches in the Cochrane Central Register of Controlled Trials (CENTRAL), major healthcare databases, trial registers and grey literature sources to ensure that the search was comprehensive.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster-randomised controlled trials (cluster-RCTs) of single and multicomponent, non-pharmacological and pharmacological interventions for preventing delirium in older people (aged 65 years and over) in permanent LTC residence.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes were prevalence, incidence and severity of delirium; and mortality. Secondary outcomes included falls, hospital admissions and other adverse events; cognitive function; new diagnoses of dementia; activities of daily living; quality of life; and cost-related outcomes. We used risk ratios (RRs) as measures of treatment effect for dichotomous outcomes, hazard ratios (HR) for time-to-event outcomes and mean difference (MD) for continuous outcomes. For each outcome, we assessed the overall certainty of the evidence using GRADE methods.\nMain results\nWe included three trials with 3851 participants. All three were cluster-RCTs. Two of the trials were of complex, single-component, non-pharmacological interventions and one trial was a feasibility trial of a complex, multicomponent, non-pharmacological intervention. Risk of bias ratings were mixed across the three trials. Due to the heterogeneous nature of the interventions, we did not combine the results statistically, but produced a narrative summary.\nIt was not possible to determine the effect of a hydration-based intervention on delirium incidence (RR 0.85, 95% confidence interval (CI) 0.18 to 4.00; 1 study, 98 participants; very low-certainty evidence downgraded for risk of bias and very serious imprecision). This study did not assess delirium prevalence, severity or mortality.\nThe introduction of a computerised system to identify medications that may contribute to delirium risk and trigger a medication review was probably associated with a reduction in delirium incidence (12-month HR 0.42, CI 0.34 to 0.51; 1 study, 7311 participant-months; moderate-certainty evidence downgraded for risk of bias) but probably had little or no effect on mortality (HR 0.88, CI 0.66 to 1.17; 1 study, 9412 participant-months; moderate-certainty evidence downgraded for imprecision), hospital admissions (HR 0.89, CI 0.72 to 1.10; 1 study, 7599 participant-months; moderate-certainty evidence downgraded for imprecision) or falls (HR 1.03, CI 0.92 to 1.15; 1 study, 2275 participant-months; low-certainty evidence downgraded for imprecision and risk of bias). Delirium prevalence and severity were not assessed.\nIn the enhanced educational intervention study, aimed at changing practice to address key delirium risk factors, it was not possible to determine the effect of the intervention on delirium incidence (RR 0.62, 95% CI 0.16 to 2.39; 1 study, 137 resident months; very low-certainty evidence downgraded for risk of bias and serious imprecision) or delirium prevalence (RR 0.57, 95% CI 0.15 to 2.19; 1 study, 160 participants; very low-certainty evidence downgraded for risk of bias and serious imprecision). There was probably little or no effect on mortality (RR 0.82, CI 0.50 to 1.34; 1 study, 215 participants; moderate-certainty evidence downgraded for imprecision). The intervention was probably associated with a reduction in hospital admissions (RR 0.67, CI 0.57 to 0.79; 1 study, 494 participants; moderate-certainty evidence downgraded due to indirectness).\nAuthors' conclusions\nOur review identified limited evidence on interventions for preventing delirium in older people in LTC. A software-based intervention to identify medications that could contribute to delirium risk and trigger a pharmacist-led medication review, probably reduces incidence of delirium in older people in institutional LTC. This is based on one large RCT in the US and may not be practical in other countries or settings which do not have comparable information technology services available in care homes. In the educational intervention aimed at identifying risk factors for delirium and developing bespoke solutions within care homes, it was not possible to determine the effect of the intervention on delirium incidence, prevalence or mortality. This evidence is based on a small feasibility trial. Our review identified three ongoing trials of multicomponent delirium prevention interventions. We identified no trials of pharmacological agents. Future trials of multicomponent non-pharmacological delirium prevention interventions for older people in LTC are needed to help inform the provision of evidence-based care for this vulnerable group.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is very low-quality evidence on the effectiveness of hydration interventions for reducing the incidence of delirium. Therefore, it was not possible to draw firm conclusions.\nThere is moderate-quality evidence that a computerised medication search programme may reduce the incidence of delirium. There is no clear evidence for reducing hospitalisations, mortality or falls.\nThere is very low-quality evidence of the effectiveness of an enhanced educational intervention for reducing delirium. Therefore, it was not possible to draw firm conclusions. There is moderate-quality evidence for reducing hospital admissions.\nAs this review only found a small number of research studies, we recommend that further research be conducted, testing different ways of preventing delirium for older people in LTC."
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query-laysum | 5353 | [
{
"role": "user",
"content": "Abstract: Background\nLow health literacy affects 25% of people with chronic kidney disease (CKD) and is associated with increased morbidity and death. Improving health literacy is a recognised priority, but effective interventions are not clear.\nObjectives\nThis review looked the benefits and harms of interventions for improving health literacy in people with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 12 July 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. We also searched MEDLINE (OVID) and EMBASE (OVID) for non-randomised studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised studies that assessed interventions aimed at improving health literacy in people with CKD.\nData collection and analysis\nTwo authors independently assessed studies for eligibility and performed risk of bias analysis. We classified studies as either interventions aimed at improving aspects of health literacy or interventions targeting a population of people with poor health literacy. The interventions were further sub-classified in terms of the type of intervention (educational, self-management training, or educational with self-management training). Results were expressed as mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CI for dichotomous outcomes.\nMain results\nWe identified 120 studies (21,149 participants) which aimed to improve health literacy. There were 107 RCTs and 13 non-randomised studies. No studies targeted low literacy populations. For the RCTs, selection bias was low or unclear in 94% of studies, performance bias was high in 86% of studies, detection bias was high in 86% of studies reporting subjective outcomes and low in 93% of studies reporting objective outcomes. Attrition and other biases were low or unclear in 86% and 78% of studies, respectively.\nCompared to usual care, low certainty evidence showed educational interventions may increase kidney-related knowledge (14 RCTs, 2632 participants: SMD 0.99, 95% CI 0.69 to 1.32; I² = 94%). Data for self-care, self-efficacy, quality of life (QoL), death, estimated glomerular filtration rate (eGFR) and hospitalisations could not be pooled or was not reported.\nCompared to usual care, low-certainty evidence showed self-management interventions may improve self-efficacy (5 RCTs, 417 participants: SMD 0.58, 95% CI 0.13 to 1.03; I² = 74%) and QoL physical component score (3 RCTs, 131 participants: MD 4.02, 95% CI 1.09 to 6.94; I² = 0%). There was moderate-certainty evidence that self-management interventions probably did not slow the decline in eGFR after one year (3 RCTs, 855 participants: MD 1.53 mL/min/1.73 m², 95% CI -1.41 to 4.46; I² = 33%). Data for knowledge, self-care behaviour, death and hospitalisations could not be pooled or was not reported.\nCompared to usual care, low-certainty evidence showed educational with self-management interventions may increase knowledge (15 RCTs, 2185 participants: SMD 0.65, 95% CI 0.36 to 0.93; I² = 90%), improve self-care behaviour scores (4 RCTs, 913 participants: SMD 0.91, 95% CI 0.00 to 1.82; I² =97%), self-efficacy (8 RCTs, 687 participants: SMD 0.50, 95% CI 0.10 to 0.89; I² = 82%), improve QoL physical component score (3 RCTs, 2771 participants: MD 2.56, 95% CI 1.73 to 3.38; I² = 0%) and may make little or no difference to slowing the decline of eGFR (4 RCTs, 618 participants: MD 4.28 mL/min/1.73 m², 95% CI -0.03 to 8.85; I² = 43%). Moderate-certainty evidence shows educational with self-management interventions probably decreases the risk of death (any cause) (4 RCTs, 2801 participants: RR 0.73, 95% CI 0.53 to 1.02; I² = 0%). Data for hospitalisation could not be pooled.\nAuthors' conclusions\nInterventions to improve aspects of health literacy are a very broad category, including educational interventions, self-management interventions and educational with self-management interventions. Overall, this type of health literacy intervention is probably beneficial in this cohort however, due to methodological limitations and high heterogeneity in interventions and outcomes, the evidence is of low certainty.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The long-term management of chronic kidney disease (CKD) requires people with the disease to be involved in their own care because it is a complex chronic disease. Many people who have CKD may not understand how to use health information to best support their decisions about treatment and management. This ability or skill is referred to as health literacy. Improving the health literacy of people with CKD may improve their health outcomes and help them to manage their disease and avoid complications."
}
]
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