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query-laysum | 4546 | [
{
"role": "user",
"content": "Abstract: Background\nAcute pancreatitis is a common and potentially lethal disease with increasing incidence. Severe cases are characterised by high mortality, and despite improvements in intensive care management, no specific treatment relevantly improves clinical outcomes of the disease. Meta-analyses suggest that enteral nutrition is more effective than conventional treatment consisting of discontinuation of oral intake with use of total parenteral nutrition. However, no systematic review has compared different enteral nutrition formulations for the treatment of patients with acute pancreatitis.\nObjectives\nTo assess the beneficial and harmful effects of different enteral nutrition formulations in patients with acute pancreatitis.\nSearch methods\nWe searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Specialised Register of Clinical Trials, the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 7), MEDLINE (from inception to 20 August 2013), EMBASE (from inception to 2013, week 33) and Science Citation Index–Expanded (from 1990 to August 2013); we conducted full-text searches and applied no restrictions by language or publication status.\nSelection criteria\nWe considered randomised clinical trials assessing enteral nutrition in patients with acute pancreatitis. We allowed concomitant interventions if they were received equally by all treatment groups within a trial.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and extracted data. We performed the analysis using Review Manager 5 (Review Manager 2013) and both fixed-effect and random-effects models. We expressed results as risk ratios (RRs) for dichotomous data, and as mean differences (MDs) for continuous data, both with 95% confidence intervals (CIs). Analysis was based on an intention-to-treat principle.\nMain results\nWe included 15 trials (1376 participants) in this review. We downgraded the quality of evidence for many of our outcomes on the basis of high risk of bias. Low-quality evidence suggests that immunonutrition decreases all-cause mortality (RR 0.49, 95% CI 0.29 to 0.80). The effect of immunonutrition on other outcomes from a subset of the included trials was uncertain. Subgrouping trials by type of enteral nutrition did not explain any variation in effect. We found mainly very low-quality evidence for the effects of probiotics on the main outcomes. One eligible trial in this comparison reported a higher rate of serious adverse events leading to increased organ failure and mortality due to low numbers of events and low risk of bias. When we excluded this study as a post hoc sensitivity analysis, risks of mortality (RR 0.30, 95% CI 0.10 to 0.84), organ failure (RR 0.74, 95% CI 0.59 to 0.92) and local septic complications (RR 0.40, 95% CI 0.22 to 0.72) were lower with probiotics. In one trial assessing immunonutrition with probiotics and fibres, no deaths occurred, but hospital stay was shorter with immunonutrition (MD -5.20 days, 95% CI -8.73 to -1.67). No deaths were reported following semi-elemental enteral nutrition (EN), and the effect on length of hospital stay was small (MD 0.30 days, 95% CI -0.82 to 1.42). Fibre-enriched formulations reduced the number of other local complications (RR 0.52, 95% CI 0.32 to 0.87) and length of hospital stay (MD -9.28 days, 95% CI -13.21 to -5.35) but did not significantly affect all-cause mortality (RR 0.23, 95% CI 0.03 to 1.84) and other outcomes. Very low-quality evidence from the subgroup of trials comparing EN versus no intervention showed a decrease in all-cause mortality with EN (RR 0.50, 95% CI 0.29 to 0.86).\nAuthors' conclusions\nWe found evidence of low or very low quality for the effects of immunonutrition on efficacy and safety outcomes. The role of supplementation of enteral nutrition with potential immunomodulatory agents remains in question, and further research is required in this area. Studies assessing probiotics yielded inconsistent and almost contrary results, especially regarding safety and adverse events, and their findings do not support the routine use of EN enriched with probiotics in routine clinical practice. However, further research should be carried out to try to determine the potential efficacy or harms of probiotics. Lack of trials reporting on other types of EN assessed and lack of firm evidence regarding their effects suggest that additional randomised clinical trials are needed. The quality of evidence for the effects of any kind of EN on mortality was low, and further studies are likely to have an impact on the finding of improved survival with EN versus no nutritional support. Evidence remains insufficient to support the use of a specific EN formulation.\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 intention of this systematic review was to show whether specific enteral nutrition (EN) formulations have any beneficial or harmful effects in the treatment of patients with acute pancreatitis (AP), and whether possible advantages and disadvantages are associated with certain types of EN in comparison with others. Enteral nutrition consists of artificial complete nutrition in liquid form that is absorbed through the intestines.\nReview authors conducted searches of available literature until August 2013 to look for studies comparing different types of EN formulations in the treatment of patients with AP. We included only randomised clinical trials in this review, as these studies, if designed and conducted properly, represent the highest methodological standard in clinical research."
}
]
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query-laysum | 4547 | [
{
"role": "user",
"content": "Abstract: Background\nDrugs used to treat psychotic illnesses may take weeks to be effective. In the interim, additional 'as required' doses of medication can be used to calm patients in psychiatric wards. The practice is widespread, with 20% to 50% of people on acute psychiatric wards receiving at least one 'as required' dose of psychotropic medication during their admission.\nObjectives\nTo compare the effects of 'as required' medication regimens with regular patterns of medication for the treatment of psychotic symptoms or behavioural disturbance, thought to be secondary to psychotic illness. These regimens may be given alone or in addition to any regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register, which is based on regular searches of MEDLINE, EMBASE, PubMed, CINAHL, BIOSIS, AMED, PsycINFO and registries of clinical trials, in November 2001, March 2006, July 2012 andOctober 2013.\nSelection criteria\nWe aimed to include all relevant randomised controlled trials involving hospital inpatients with schizophrenia or schizophrenia-like illnesses, comparing any regimen of medication administered for the short-term relief of behavioural disturbance, or psychotic symptoms, to be given at the discretion of ward staff ('as required', 'prn') with fixed non-discretionary patterns of drug administration of the same drug(s). This was in addition to regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses where prescribed.\nData collection and analysis\nWe independently inspected abstracts and papers for inclusion. If trials had been found, we would have extracted data from the papers and quality assessed the data. For dichotomous data we would have calculated the risk ratios (RR), with the 95% confidence intervals (CI). We would have conducted analyses on an intention-to-treat basis. If data were available we would have completed a 'Summary of findings' table using GRADE.\nMain results\nWe have not been able to identify any randomised trials comparing 'as required' medication regimens to regular regimens of the same drug. Our main outcomes of interest were important changes in (i) mental state, (ii) behaviour, (iii) dose of medication used, (iv) adverse events, (v) satisfaction with care and (iv) cost of care.\nAuthors' conclusions\nThere is currently no evidence from within randomised trials to support this common practice. Current practice is based on clinical experience and habit rather than high quality evidence.\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": "The search only found trials that compared two different drugs, both of which were used 'as required'. The review authors found no trials that compared only giving additional medication when needed with regular doses of the same medication."
}
]
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query-laysum | 4548 | [
{
"role": "user",
"content": "Abstract: Background\nUpper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. People with liver disease frequently have haemostatic abnormalities such as hyperfibrinolysis. Therefore, antifibrinolytic amino acids have been proposed to be used as supplementary interventions alongside any of the primary treatments for upper gastrointestinal bleeding in people with liver diseases. This is an update of this Cochrane review.\nObjectives\nTo assess the beneficial and harmful effects of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), LILACS (1982 to February 2015), World Health Organization Clinical Trials Search Portal (accessed 26 February 2015), and the metaRegister of Controlled Trials (accessed 26 February 2015). We scrutinised the reference lists of the retrieved publications.\nSelection criteria\nRandomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. Observational studies for assessment of harms.\nData collection and analysis\nWe planned to summarise data from randomised clinical trials using standard Cochrane methodologies and assessed according to the GRADE approach.\nMain results\nWe found no randomised clinical trials assessing antifibrinolytic amino acids for treating upper gastrointestinal bleeding in people with acute or chronic liver disease. We did not identify quasi-randomised, historically controlled, or observational studies in which we could assess harms.\nAuthors' conclusions\nThis updated Cochrane review identified no randomised clinical trials assessing the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. The benefits and harms of antifibrinolytic amino acids need to be tested in randomised clinical trials. Unless randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver diseases.\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 no randomised clinical trials (studies where people are randomly put into one of two or more treatment groups) for inclusion in this updated review on the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with liver diseases. The evidence is current to February 2015."
}
]
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query-laysum | 4549 | [
{
"role": "user",
"content": "Abstract: Background\nTofacitinib is an oral Janus kinase (JAK) inhibitor which blocks cytokine signaling involved in the pathogenesis of autoimmune diseases including ulcerative colitis (UC). The etiology of UC is poorly understood, however research suggests the development and progression of the disease is due to a dysregulated immune response leading to inflammation of the colonic mucosa in genetically predisposed individuals. Additional medications are currently required since some patients do not respond to the available medications and some medications are associated with serious adverse events (SAEs). JAK inhibitors have been widely studied in diseases including rheumatoid arthritis and Crohn's disease and may represent a promising and novel therapeutic option for the treatment of UC.\nObjectives\nThe primary objective was to assess the efficacy and safety of oral JAK inhibitors for the maintenance of remission in participants with quiescent UC.\nSearch methods\nWe searched the following databases from inception to 20 September 2019: MEDLINE, Embase, CENTRAL, and the Cochrane IBD Group Specialized Register, WHO trials registry and clinicaltrials.gov. References and conference abstracts were searched to identify additional studies.\nSelection criteria\nRandomized control trial (RCTs) in which an oral JAK inhibitor was compared with placebo or active comparator in the treatment of quiescent UC were eligible for inclusion.\nData collection and analysis\nTwo review authors independently screened studies for inclusion and extraction. Bias was assessed using the Cochrane 'Risk of bias' tool. The primary outcome was the proportion of participants who failed to maintain remission as defined by any included studies. Secondary outcomes included failure to maintain clinical response, failure to maintain endoscopic remission, failure to maintain endoscopic response, disease-specific quality of life, adverse events (AEs), withdrawal due to AEs and SAEs. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for each dichotomous outcome. Data were analyzed on an intention-to-treat basis. The overall certainty of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nOne RCT (593 participants) including patients with moderately to severely active UC met the inclusion criteria. Patients who achieved a clinical response after eight weeks of induction treatment with tofacitinib (10 mg twice daily) or placebo were randomly assigned in a 1:1:1 ratio to receive maintenance therapy with tofacitinib at 5 mg twice daily, 10 mg twice daily or placebo for 52 weeks. The primary endpoint was remission at 52 weeks and the secondary endpoints included mucosal healing at 52 weeks, sustained remission at 24 and 52 weeks and glucocorticosteroid-free remission. This study was rated as low risk of bias. The study did not report on the proportion of participants who maintained remission at 52 weeks as clinical remission was not required for study entry (just clinical response). Thus we report on the proportion of participants who achieved clinical remission, clinical response, and endoscopic remission at 52 weeks; the proportion of participants who maintained remission at 52 weeks, and on AEs, SAEs and withdrawal due to AEs. However, the included study did not report on endoscopic response or disease-specific quality of life.\nSixty-three per cent (247/395) of tofacitinib participants failed to achieve clinical remission at 52 weeks compared to 89% (176/198) of placebo participants (RR 0.70, 95% CI 0.64 to 0.77; high-certainty evidence). The number needed to treat for an additional beneficial outcome is 4. Forty-three per cent (171/395) of tofacitinib participants failed to maintain clinical response at 52 weeks compared to 80% (158/198) of placebo participants (RR 0.54, 95% CI 0.48 to 0.62; high-certainty evidence). Eighty-four per cent (333/395) of tofacitinib participants failed to achieve endoscopic remission at 52 weeks compared to 96% (190/198) of placebo participants (RR 0.88, 95% CI 0.83 to 0.92; high-certainty evidence).\nAEs were reported in 76% (299/394) of tofacitinib participants compared with 75% (149/198) of placebo participants (RR 1.01, 95% CI 0.92 to 1.11; high-certainty evidence). Commonly reported AEs included worsening UC, nasopharyngitis, arthralgia (joint pain)and headache. SAEs were reported in 5% (21/394) of tofacitinib participants compared with 7% (13/198) of placebo participants (RR 0.81, 95% CI 0.42 to 1.59; low-certainty evidence). SAEs included non-melanoma skin cancers, cardiovascular events, cancer other than non-melanoma skin cancer, Bowen's disease, skin papilloma and uterine leiomyoma (a tumour in the uterus). There was a higher proportion of participants who withdrew due to an AE in the placebo group compared to the tofacitinib group. Nine per cent (37/394) of participants taking tofacitinib withdrew due to an AE compared to 19% (37/198) of participants taking placebo (RR 0.50, 95% CI 0.33 to 0.77; moderate-certainty evidence). The most common reason for withdrawal due to an AE was worsening UC. The included study did not report on endoscopic response or on mean disease-specific quality of life scores.\nAuthors' conclusions\nHigh-certainty evidence suggests that tofacitinib is superior to placebo for induction of clinical and endoscopic remission at 52 weeks in participants with moderate-to-severe UC who had a clinical response after eight weeks of induction treatment with tofacitinib (10 mg twice daily) or placebo. The optimal dose of tofacitinib for maintenance therapy is unknown. High-certainty evidence suggests that there is no increased risk of AEs with tofacitinib compared to placebo. However, we are uncertain about the effect of tofacitinib on SAEs due to the low number of events. Further studies are required to look at the long-term effectiveness and safety of using tofacitinib and other oral JAK inhibitors as maintenance therapy in participants with moderate-to-severe UC in remission.\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 one study (593 participants) that compared tofacitinib versus a placebo (a fake medicine). The participants had moderate-to-severe ulcerative colitis that responded to tofacitinib or placebo induction therapy (10 mg twice daily for eight weeks). The study was of high methodological quality. High-certainty evidence suggests that tofacitinib (5 mg or 10 mg twice daily) is more effective than placebo at achieving clinical remission (stopping of symptoms) and endoscopic remission (i.e. healing of inflamed bowel mucosa) of ulcerative colitis at 52 weeks. The rates of side effects (tofacitinib: 76%; placebo: 75%) and serious side effects (tofacitinib: 5%; placebo: 7%) were similar in participants receiving tofacitinib and placebo. High-certainty evidence suggests there is no increased risk of side effects with tofacitinib compared to placebo. Commonly reported side effects included worsening ulcerative colitis, nasopharyngitis (i.e. common cold), arthralgia (i.e. joint pain) and headache. The certainty of the evidence for serious side effects was low due to a low number of events. Serious side effects included non-melanoma skin cancers, cardiovascular events (e.g. heart attack), cancer other than non-melanoma skin cancer, Bowen's disease (i.e. a type of skin cancer), skin papilloma (i.e. a tumour of the skin) and uterine leiomyoma (i.e. a tumour in the uterus). In addition, there was a higher rate of withdrawal from the study due to side effects in the placebo group compared to the treatment group. Nine per cent of participants taking tofacitinib withdrew due to a side effect compared to 19% of participants taking placebo (moderate-certainty evidence). The most common reason for study withdrawal due to a side effect was worsening ulcerative colitis."
}
]
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query-laysum | 4550 | [
{
"role": "user",
"content": "Abstract: Background\nUveitis is the most common extra-articular manifestation of juvenile idiopathic arthritis (JIA) and a potentially sight-threatening condition characterized by intraocular inflammation. Current treatment for JIA-associated uveitis (JIA-U) is largely based on physician experience, observational evidence and consensus guidelines, resulting in considerable variations in practice.\nObjectives\nTo evaluate the effectiveness and safety of tumor necrosis factor (TNF) inhibitors used for treatment of JIA-U.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We last searched the electronic databases on 3 February 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing TNF inhibitors with placebo in participants with a diagnosis of JIA and uveitis who were aged 2 to 18 years old.\nData collection and analysis\nWe used standard Cochrane methodology and graded the certainty of the body of evidence for seven outcomes using the GRADE classification.\nMain results\nWe included three RCTs with 134 participants.\nOne study conducted in the USA randomized participants to etanercept or placebo (N = 12). Two studies, one conducted in the UK (N = 90) and one in France (N = 32), randomized participants to adalimumab or placebo. All studies were at low risk of bias. Initial pooled estimates suggested that TNF-inhibitors may result in little to no difference on treatment success defined as 0 to trace cells on Standardization of Uveitis Nomenclature (SUN)-grading; or two-step decrease in activity based on SUN grading (estimated risk ratio (RR) 0.66; 95% confidence interval (CI) 0.21 to 2.10; 2 studies; 43 participants; low-certainty evidence) or treatment failure defined as a two-step increase in activity based on SUN grading (RR 0.31; 95% CI 0.01 to 7.15; 1 study; 31 participants; low-certainty evidence). Further analysis using the individual trial definitions of treatment response and failure suggested a positive treatment effect of TNF inhibitors; a RR of treatment success of 2.60 (95% CI 1.30 to 5.20; 3 studies; 124 participants; low-certainty evidence), and RR of treatment failure of 0.23 (95% CI 0.11 to 0.50; 3 studies; 133 participants). Almost all the evidence was on adalimumab and the evidence on etanercept was very limited. For secondary outcomes, one study suggests that adalimumab may have little to no effect on risk of recurrence after induction of remission at three months (RR 2.50, 95% CI 0.31 to 20.45; 90 participants; very low-certainty evidence) and visual acuity, but the evidence is very uncertain; mean difference in longitudinal logMAR score change over six months was -0.01 (95% CI –0.06 to 0.03) and -0.02 (95% CI –0.07 to 0.03) using the best and worst logMAR measurement, respectively (low-certainty evidence). Low-certainty evidence from one study suggested that adalimumab treatment results in reduction of topical steroid doses at six months (hazard ratio 3.58; 95% CI 1.24 to 10.32; 74 participants who took one or more topical steroid per day at baseline). Adverse events, including injection site reactions and infections, were more common in the TNF inhibitor group. Serious adverse events were uncommon.\nAuthors' conclusions\nAdalimumab appears to increase the likelihood of treatment success and decrease the likelihood of treatment failure when compared with placebo. The evidence was less conclusive about a positive treatment effect with etanercept. Adverse events from JIA-U trials are in keeping with the known side effect profile of TNF inhibitors. Standard validated JIA-U outcome measures are required to homogenize assessment and to allow for comparison and analysis of multiple datasets.\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 the medical literature for studies comparing TNF inhibitor to placebo for JIA-associated uveitis. We summarized the evidence for our pre-defined outcomes and graded our confidence in the evidence. Given that included studies did not measure or report our pre-defined outcomes, we additionally summarized the evidence as report by the individual studies"
}
]
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query-laysum | 4551 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review, first published in 2005.\nHemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA).\nObjectives\nTo compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020.\nSelection criteria\nDouble-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS.\nData collection and analysis\nTwo review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event.\nMain results\nWe found no parallel-group randomised controlled trials comparing BtA and placebo in HFS.\nAuthors' conclusions\nWe did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"The review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of botulinum toxin type A (BtA) in people with one-sided, involuntary contractions of facial muscles, or hemifacial spasm. This is an update of a previous Cochrane Review: we assessed the efficacy (reduction in severity and disability) and safety of BtA versus placebo (a pretend medicine) in hemifacial spasm."
}
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query-laysum | 4552 | [
{
"role": "user",
"content": "Abstract: Background\nThis an update of a Cochrane Review.\nParaquat is a widely used herbicide, but is also a lethal poison. In some low- and middle-income countries (LMICs) paraquat is commonly available and inexpensive, making poisoning prevention difficult. Most of the people poisoned by paraquat have taken it as a means of self-poisoning.\nStandard treatment for paraquat poisoning prevents further absorption and reduces the load of paraquat in the blood through haemoperfusion or haemodialysis. The effectiveness of standard treatments is extremely limited.\nThe immune system plays an important role in exacerbating paraquat-induced lung fibrosis. Immunosuppressive treatment using glucocorticoid and cyclophosphamide in combination has been developed and studied as an intervention for paraquat poisoning.\nObjectives\nTo assess the effects of glucocorticoid with cyclophosphamide for moderate to severe oral paraquat poisoning.\nSearch methods\nThe most recent searches were run in September 2020. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Injuries Trials Register), Ovid MEDLINE(R), Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid OLDMEDLINE, Embase Classic + Embase (Ovid), ISI WOS (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), and trials registries. We also searched the following three resources: China National Knowledge Infrastructure database (CNKI 数据库); Wanfang Data (万方数据库); and VIP (维普数据库) on 12 November 2020. We examined the reference lists of included studies and review papers.\nSelection criteria\nWe included randomised controlled trials (RCTs). For this update, in accordance with Cochrane Injuries' Group policy (2015), we included only prospectively registered RCTs for trials published after 2010. We included trials which assessed the effects of glucocorticoid with cyclophosphamide delivered in combination. Eligible comparators were standard care (with or without a placebo), or any other therapy in addition to standard care. Outcomes of interest included mortality and infections.\nData collection and analysis\nWe calculated the mortality risk ratio (RR) and 95% confidence interval (CI). Where possible, we summarised data for all-cause mortality at relevant time periods (from hospital discharge to three months after discharge) in meta-analysis, using a fixed-effect model. We conducted sensitivity analyses based on factors including whether participants were assessed at baseline for plasma paraquat levels. We also reported data on infections within one week after initiation of treatment.\nMain results\nWe included four trials with a total of 463 participants. The included studies were conducted in Taiwan (Republic of China), Iran, and Sri Lanka. Most participants were male. The mean age of participants was 28 years.\nWe judged two of the four included studies, including the largest and most recently conducted study (n = 299), to be at low risk of bias for key domains including sequence generation. We assessed one study to be at high risk of selection bias and another at unclear risk, since allocation concealment was either not mentioned in the trial report or explicitly not undertaken. We assessed three of the four studies to be at unclear risk of selective reporting, as no protocols could be identified. An important source of heterogeneity amongst the included studies was the method of assessment of participants' baseline severity using analysis of plasma levels (two studies employed this method, whilst the other two did not).\nNo studies assessed the outcome of mortality at 30 days following ingestion of paraquat.\nLow-certainty evidence from two studies indicates that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce the risk of death in hospital compared to standard care alone ((RR 0.82, 95% CI 0.68 to 0.99; participants = 322); results come from sensitivity analysis excluding studies not assessing plasma at baseline). However, we have limited confidence in this finding as heterogeneity was high (I2 = 77%) and studies varied in terms of size and comparators. A single large study provided data showing that there may be little or no effect of treatment at three months post discharge from hospital (RR 0.98, 95% CI 0.85 to 1.13; 1 study, 293 participants; low-certainty evidence); however, analysis of long-term results amongst participants whose injuries arose from self-poisoning must be interpreted with caution.\nWe remain uncertain of the effect of glucocorticoids with cyclophosphamide on infection within one week after initiation of the treatment; this outcome was assessed by two small studies only (31 participants, very low-certainty evidence) that considered leukopenia as a proxy or risk factor for infection. Neither study reported infections in any participants.\nAuthors' conclusions\nLow-certainly evidence suggests that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce mortality in hospitalised people with oral paraquat poisoning. However, we have limited confidence in this finding because of substantial heterogeneity and concerns about imprecision. Glucocorticoids with cyclophosphamide in addition to standard care may have little or no effect on mortality at three months after hospital discharge. We are uncertain whether glucocorticoid with cyclophosphamide puts patients at an increased risk of infection due to the limited evidence available for this outcome. Future research should be prospectively registered and CONSORT-compliant. Investigators should attempt to ensure an adequate sample size, screen participants for inclusion rigorously, and seek long-term follow-up of participants. Investigators may wish to research the effects of glucocorticoid in combination with other treatments.\n\nGiven the provided abstract, please respond to the following query: \"Death 3 months after hospital discharge\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One large study showed that at 3 months after discharge from hospital there may be no difference in the number of deaths between the people treated with steroids plus cyclophosphamide (plus usual care) and those treated with usual care alone."
}
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query-laysum | 4553 | [
{
"role": "user",
"content": "Abstract: Background\nHigh-flow nasal cannulae (HFNC) deliver high flows of blended humidified air and oxygen via wide-bore nasal cannulae and may be useful in providing respiratory support for adults experiencing acute respiratory failure, or at risk of acute respiratory failure, in the intensive care unit (ICU). This is an update of an earlier version of the review.\nObjectives\nTo assess the effectiveness of HFNC compared to standard oxygen therapy, or non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV), for respiratory support in adults in the ICU.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane COVID-19 Register (17 April 2020), clinical trial registers (6 April 2020) and conducted forward and backward citation searches.\nSelection criteria\nWe included randomized controlled studies (RCTs) with a parallel-group or cross-over design comparing HFNC use versus other types of non-invasive respiratory support (standard oxygen therapy via nasal cannulae or mask; or NIV or NIPPV which included continuous positive airway pressure and bilevel positive airway pressure) in adults admitted to the ICU.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included 31 studies (22 parallel-group and nine cross-over designs) with 5136 participants; this update included 20 new studies. Twenty-one studies compared HFNC with standard oxygen therapy, and 13 compared HFNC with NIV or NIPPV; three studies included both comparisons. We found 51 ongoing studies (estimated 12,807 participants), and 19 studies awaiting classification for which we could not ascertain study eligibility information.\nIn 18 studies, treatment was initiated after extubation. In the remaining studies, participants were not previously mechanically ventilated.\nHFNC versus standard oxygen therapy\nHFNC may lead to less treatment failure as indicated by escalation to alternative types of oxygen therapy (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.45 to 0.86; 15 studies, 3044 participants; low-certainty evidence). HFNC probably makes little or no difference in mortality when compared with standard oxygen therapy (RR 0.96, 95% CI 0.82 to 1.11; 11 studies, 2673 participants; moderate-certainty evidence). HFNC probably results in little or no difference to cases of pneumonia (RR 0.72, 95% CI 0.48 to 1.09; 4 studies, 1057 participants; moderate-certainty evidence), and we were uncertain of its effect on nasal mucosa or skin trauma (RR 3.66, 95% CI 0.43 to 31.48; 2 studies, 617 participants; very low-certainty evidence). We found low-certainty evidence that HFNC may make little or no difference to the length of ICU stay according to the type of respiratory support used (MD 0.12 days, 95% CI -0.03 to 0.27; 7 studies, 1014 participants). We are uncertain whether HFNC made any difference to the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) within 24 hours of treatment (MD 10.34 mmHg, 95% CI -17.31 to 38; 5 studies, 600 participants; very low-certainty evidence). We are uncertain whether HFNC made any difference to short-term comfort (MD 0.31, 95% CI -0.60 to 1.22; 4 studies, 662 participants, very low-certainty evidence), or to long-term comfort (MD 0.59, 95% CI -2.29 to 3.47; 2 studies, 445 participants, very low-certainty evidence).\nHFNC versus NIV or NIPPV\nWe found no evidence of a difference between groups in treatment failure when HFNC were used post-extubation or without prior use of mechanical ventilation (RR 0.98, 95% CI 0.78 to 1.22; 5 studies, 1758 participants; low-certainty evidence), or in-hospital mortality (RR 0.92, 95% CI 0.64 to 1.31; 5 studies, 1758 participants; low-certainty evidence). We are very uncertain about the effect of using HFNC on incidence of pneumonia (RR 0.51, 95% CI 0.17 to 1.52; 3 studies, 1750 participants; very low-certainty evidence), and HFNC may result in little or no difference to barotrauma (RR 1.15, 95% CI 0.42 to 3.14; 1 study, 830 participants; low-certainty evidence). HFNC may make little or no difference to the length of ICU stay (MD -0.72 days, 95% CI -2.85 to 1.42; 2 studies, 246 participants; low-certainty evidence). The ratio of PaO2/FiO2 may be lower up to 24 hours with HFNC use (MD -58.10 mmHg, 95% CI -71.68 to -44.51; 3 studies, 1086 participants; low-certainty evidence). We are uncertain whether HFNC improved short-term comfort when measured using comfort scores (MD 1.33, 95% CI 0.74 to 1.92; 2 studies, 258 participants) and responses to questionnaires (RR 1.30, 95% CI 1.10 to 1.53; 1 study, 168 participants); evidence for short-term comfort was very low certainty. No studies reported on nasal mucosa or skin trauma.\nAuthors' conclusions\nHFNC may lead to less treatment failure when compared to standard oxygen therapy, but probably makes little or no difference to treatment failure when compared to NIV or NIPPV. For most other review outcomes, we found no evidence of a difference in effect. However, the evidence was often of low or very low certainty. We found a large number of ongoing studies; including these in future updates could increase the certainty or may alter the direction of these effects.\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": "Are high-flow nasal cannulae (HFNC) a helpful treatment option for adult patients in the intensive care unit (ICU) who need breathing support?"
}
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query-laysum | 4554 | [
{
"role": "user",
"content": "Abstract: Background\nHyaluronidase has been used over many decades as an adjunct to local anaesthetic solution to improve the speed of onset of eye blocks and to provide better akinesia and analgesia. With the evolution of modern eye surgery techniques, fast onset and akinesia are not essential requirements anymore. The assumption that the addition of hyaluronidase to local anaesthetic injections confers better analgesia for the patient needs to be examined. There has been no recent systematic review to provide evidence that hyaluronidase actually improves analgesia.\nObjectives\nTo ascertain if adding hyaluronidase to local anaesthetic solutions for use in ophthalmic anaesthesia in adults results in a reduction of perceived pain during the operation and to assess harms, participant and surgical satisfaction, and economic impact.\nSearch methods\nWe carried out systematic searches in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and four other databases in June 2017. We searched the trial registers at www.ISRCTN.com, ClinicalTrials.gov and www.clinicaltrialsregister.eu for relevant trials. We imposed no language restrictions.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated the effect of hyaluronidase on pain experienced by adults during intraocular surgery using a rating scale.\nData collection and analysis\nTwo review authors (HR and KA) independently extracted data and assessed methodological quality using standard procedures as expected by Cochrane.\nMain results\nWe included seven trials involving 500 participants that studied the effect of hyaluronidase on intraoperative pain. Four of the seven trials with 289 participants reported the primary outcome in a dichotomous manner, and we proceeded to meta-analyse the findings which showed a moderate heterogeneity that could not be explained (I2 = 41% ). The pooled risk ratio (RR) for these four trials was 0.83 with the 95% confidence interval ranging from 0.48 to 1.42. The reduction in intraoperative pain scores in the hyaluronidase group were not statistically significant. Among the three trials that reported the primary outcome in a continuous manner, the presence of missing data made it difficult to conduct a meta-analysis. To further explore the data, we imputed standard deviations for the other studies from another included RCT (Sedghipour 2012). However, this resulted in substantial heterogeneity between study estimates (I² = 76% ). The lack of reported relevant data in two of the three remaining trials made it difficult to assess the direction of effect in a clinical setting.\nOverall, there was no statistical difference regarding the intraoperative reduction of pain scores between the hyaluronidase and control group. All seven included trials had a low risk of bias.\nAccording to GRADE, we found the quality of evidence was low and downgraded the trials for serious risk of inconsistency and imprecision. Therefore, the results should be analysed with caution.\nParticipant satisfaction scores were significantly higher in the hyaluronidase group in two high quality trials with 122 participants. Surgical satisfaction was also superior in two of three high quality trials involving 141 participants. According to GRADE, the quality of evidence was moderate for participant and surgical satisfaction as the trials were downgraded for imprecision due to the small sample sizes. The risk of bias in these trials was low.\nThere was no reported harm due to the addition of hyaluronidase in any of the studies. No study reported on the cost of hyaluronidase in the context of eye surgery.\nAuthors' conclusions\nThe effects of adding hyaluronidase to local anaesthetic fluid on pain outcomes in people undergoing eye surgery are uncertain due to the low quality of evidence available. A well designed RCT is required to address inconsistency and imprecision among the studies and to determine the benefit of hyaluronidase to improve analgesia during eye surgery. Participant and surgical satisfaction is higher with hyaluronidase compared to the control groups, as demonstrated in moderate quality studies. There was no harm attributed to the use of hyaluronidase in any of the studies. Considering that harm was only rarely defined as an outcome measure, and the overall small number of participants, conclusions cannot be drawn about the incidence of harmful effects of hyaluronidase. None of the studies undertook cost calculations with regards to use of hyaluronidase in local anaesthetic eye blocks.\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": "Hyaluronidase is an enzyme (a protein that regulates a chemical reaction in the body) that helps the spread of local anaesthetic through the tissues around the eye. It is widely used as an additive to local anaesthetic eye blocks to give more rapid onset of anaesthesia and reduce or block movement of the eye (called akinesia). With modern eye surgery techniques, fast onset and akinesia are no longer essential requirements, and often surgery can be undertaken pain-free with topical (on the surface of the eye) anaesthesia alone. Hyaluronidase has been associated with infrequent side effects. Therefore, the use of hyaluronidase needs to be justified, which was the aim of this review."
}
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query-laysum | 4555 | [
{
"role": "user",
"content": "Abstract: Background\nHomocystinuria is a rare inherited disorder due to a deficiency in cystathionine beta synthase. Individuals with this condition appear normal at birth but develop serious complications in childhood. Diagnosis and treatment started sufficiently early in life can effectively prevent or reduce the severity of these complications. This is an update of a previously published review.\nObjectives\nTo determine if newborn population screening for the diagnosis of homocystinuria due to cystathionine beta synthase deficiency leads to clinical benefit compared to later clinical diagnosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register.\nDate of the most recent search of the Inborn Errors of Metabolism Register: 08 June 2015.\nSelection criteria\nRandomised controlled trials and controlled clinical trials assessing the use of any neonatal screening test to diagnose infants with homocystinuria before the condition becomes clinically evident. Eligible studies compare a screened population versus a non-screened population.\nData collection and analysis\nNo studies were identified for inclusion in the review.\nMain results\nNo studies were identified for inclusion in the review.\nAuthors' conclusions\nWe were unable to identify eligible studies for inclusion in this review and hence it is not possible to draw any conclusions based on controlled studies; however, we are aware of uncontrolled case-series which support the efficacy of newborn screening for homocystinuria and its early treatment. Any future randomised controlled trial would need to be both multicentre and long term in order to provide robust evidence for or against screening and to allow a cost effectiveness analysis to be undertaken.\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": "Homocystinuria is a rare condition caused by mistakes in a gene that is responsible for making an enzyme called cystathionine beta synthase. People with homocystinuria have a deficiency of this enzyme and as a result have high levels of a substance called homocysteine in their bodies. Although such individuals appear normal at birth, over a period of months and years, they develop serious problems that effect eyesight, lead to delayed mental development, cause unhealthy bones, and have a high risk of having blood clots. Treatment with a special diet and medicines can prevent the development of these complications, but must be started very early in life to be truly effective. In some parts of the world homocystinuria has been tested for in newborn babies."
}
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query-laysum | 4556 | [
{
"role": "user",
"content": "Abstract: Background\nSelf-management interventions help people with chronic obstructive pulmonary disease (COPD) to acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable them to control their disease. Since the 2014 update of this review, several studies have been published.\nObjectives\nPrimary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of health-related quality of life (HRQoL) and respiratory-related hospital admissions.\nTo evaluate the safety of COPD self-management interventions compared to usual care in terms of respiratory-related mortality and all-cause mortality.\nSecondary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of other health outcomes and healthcare utilisation.\nTo evaluate effective characteristics of COPD self-management interventions.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, EMBASE, trials registries and the reference lists of included studies up until January 2020.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-randomised trials (CRTs) published since 1995. To be eligible for inclusion, self-management interventions had to include at least two intervention components and include an iterative process between participant and healthcare provider(s) in which goals were formulated and feedback was given on self-management actions by the participant.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. We contacted study authors to obtain additional information and missing outcome data where possible. Primary outcomes were health-related quality of life (HRQoL), number of respiratory-related hospital admissions, respiratory-related mortality, and all-cause mortality. When appropriate, we pooled study results using random-effects modelling meta-analyses.\nMain results\nWe included 27 studies involving 6008 participants with COPD. The follow-up time ranged from two-and-a-half to 24 months and the content of the interventions was diverse. Participants' mean age ranged from 57 to 74 years, and the proportion of male participants ranged from 33% to 98%. The post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of participants ranged from 33.6% to 57.0%. The FEV1/FVC ratio is a measure used to diagnose COPD and to determine the severity of the disease. Studies were conducted on four different continents (Europe (n = 15), North America (n = 8), Asia (n = 1), and Oceania (n = 4); with one study conducted in both Europe and Oceania).\nSelf-management interventions likely improve HRQoL, as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score (lower score represents better HRQoL) with a mean difference (MD) from usual care of -2.86 points (95% confidence interval (CI) -4.87 to -0.85; 14 studies, 2778 participants; low-quality evidence). The pooled MD of -2.86 did not reach the SGRQ minimal clinically important difference (MCID) of four points. Self-management intervention participants were also at a slightly lower risk for at least one respiratory-related hospital admission (odds ratio (OR) 0.75, 95% CI 0.57 to 0.98; 15 studies, 3263 participants; very low-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over a mean of 9.75 months' follow-up was 15 (95% CI 8 to 399) for participants with high baseline risk and 26 (95% CI 15 to 677) for participants with low baseline risk. No differences were observed in respiratory-related mortality (risk difference (RD) 0.01, 95% CI -0.02 to 0.04; 8 studies, 1572 participants ; low-quality evidence) and all-cause mortality (RD -0.01, 95% CI -0.03 to 0.01; 24 studies, 5719 participants; low-quality evidence).\nWe graded the evidence to be of ‘moderate’ to ‘very low’ quality according to GRADE. All studies had a substantial risk of bias, because of lack of blinding of participants and personnel to the interventions, which is inherently impossible in a self-management intervention. In addition, risk of bias was noticeably increased because of insufficient information regarding a) non-protocol interventions, and b) analyses to estimate the effect of adhering to interventions. Consequently, the highest GRADE evidence score that could be obtained by studies was ‘moderate’.\nAuthors' conclusions\nSelf-management interventions for people with COPD are associated with improvements in HRQoL, as measured with the SGRQ, and a lower probability of respiratory-related hospital admissions. No excess respiratory-related and all-cause mortality risks were observed, which strengthens the view that COPD self-management interventions are unlikely to cause harm. By using stricter inclusion criteria, we decreased heterogeneity in studies, but also reduced the number of included studies and therefore our capacity to conduct subgroup analyses. Data were therefore still insufficient to reach clear conclusions about effective (intervention) characteristics of COPD self-management interventions. As tailoring of COPD self-management interventions to individuals is desirable, heterogeneity is and will likely remain present in self-management interventions.\nFor future studies, we would urge using only COPD self-management interventions that include iterative interactions between participants and healthcare professionals who are competent using behavioural change techniques (BCTs) to elicit participants' motivation, confidence and competence to positively adapt their health behaviour(s) and develop skills to better manage their disease. In addition, to inform further subgroup and meta-regression analyses and to provide stronger conclusions regarding effective COPD self-management interventions, there is a need for more homogeneity in outcome measures. More attention should be paid to behavioural outcome measures and to providing more detailed, uniform and transparently reported data on self-management intervention components and BCTs. Assessment of outcomes over the long term is also recommended to capture changes in people's behaviour. Finally, information regarding non-protocol interventions as well as analyses to estimate the effect of adhering to interventions should be included to increase the quality of evidence.\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": "COPD is a common and long-term lung condition that slowly worsens over the years, and causes symptoms such as breathlessness, coughing, wheezing and increased sputum (mucus) production. This leads to loss of well-being (also known as reduction in HRQoL) in people with COPD. Self-management interventions encourage people to develop the skills and behaviours they need to successfully manage their disease, and the emotional and practical issues that may go along with it. In this update, we reviewed the current evidence on the effects of self-management on HRQoL, hospital admissions related to COPD, deaths from any cause and related to COPD, as well as other health outcomes."
}
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query-laysum | 4557 | [
{
"role": "user",
"content": "Abstract: Background\nSupplementary oxygen is routinely administered to low-risk pregnant women during an elective caesarean section under regional anaesthesia; however, maternal and foetal outcomes have not been well established. This is an update of a review first published in 2013.\nObjectives\nThe primary objective was to determine whether supplementary oxygen given to low-risk term pregnant women undergoing elective caesarean section under regional anaesthesia can prevent maternal and neonatal desaturation. The secondary objective was to compare the mean values of maternal and neonatal blood gas levels between mothers who received supplementary oxygen and those who did not (control group).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, issue 11), MEDLINE (1948 to November 2014) and EMBASE (1980 to November 2014). The original search was first performed in February 2012. We reran the search in CENTRAL, MEDLINE, EMBASE in February 2016. One potential new study of interest was added to the list of ‘Studies awaiting Classification' and will be incorporated into the formal review findings during the next review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) of low-risk pregnant women undergoing an elective caesarean section under regional anaesthesia and compared outcomes with, and without, oxygen supplementation.\nData collection and analysis\nTwo review authors independently extracted data, assessed methodological quality and performed subgroup and sensitivity analyses.\nMain results\nWe found one new included study in this updated version. In total, our updated review includes 11 trials (with 753 participants). The low quality of evidence showed no significant differences in average Apgar scores at one minute (N = six trials, 519 participants; 95% confidence (CI) -0.16 to 0.31, P = 0.53) and at five minutes (N = six trials, 519 participants; 95% CI -0.06 to 0.06, P = 0.98). None of the 11 trials reported maternal desaturation. The very low quality of evidence showed that in comparison to room air, women in labour receiving supplementary oxygen had higher maternal oxygen saturation (N = three trials, 209 participants), maternal PaO2 (oxygen pressure in the blood; N = six trials, 241 participants), UaPO2 (foetal umbilical arterial blood; N = eight trials, 504 participants; 95% CI 1.8 to 4.9, P < 0.0001) and UvPO2 (foetal umbilical venous blood; N = 10 trials, 683 participants). There was high heterogeneity among these outcomes. A subgroup analysis showed no significant difference in UaPO2 between the two intervention groups in low-risk studies, whereas the high-risk studies showed a benefit for the neonatal oxygen group.\nAuthors' conclusions\nOverall, we found no convincing evidence that giving supplementary oxygen to healthy term pregnant women during elective caesarean section under regional anaesthesia is either beneficial or harmful for either the mother or the foetus' short-term clinical outcome as assessed by Apgar scores. Although, there were significant higher maternal and neonatal blood gas values and markers of free radicals when extra oxygen was given, the results should be interpreted with caution due to the low grade quality of the evidence.\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 is current to November 2014.We reran the search in CENTRAL, MEDLINE, EMBASE in February 2016. We found one potential new study of interest which was added to the list of ‘Studies awaiting Classification'. This study will be incorporated into the formal review findings when we next update the review."
}
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query-laysum | 4558 | [
{
"role": "user",
"content": "Abstract: Background\nUterine fibroids are smooth muscle tumours arising from the uterus. These tumours, although benign, are commonly associated with abnormal uterine bleeding, bulk symptoms and reproductive dysfunction. The importance of progesterone in fibroid pathogenesis supports selective progesterone receptor modulators (SPRMs) as effective treatment. Both biochemical and clinical evidence suggests that SPRMs may reduce fibroid growth and ameliorate symptoms. SPRMs can cause unique histological changes to the endometrium that are not related to cancer, are not precancerous and have been found to be benign and reversible. This review summarises randomised trials conducted to evaluate the effectiveness of SPRMs as a class of medication for treatment of individuals with fibroids.\nObjectives\nTo evaluate the effectiveness and safety of SPRMs for treatment of premenopausal women with uterine fibroids.\nSearch methods\nWe searched the Specialised Register of the Cochrane Gynaecology and Fertility Group, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and clinical trials registries from database inception to May 2016. We handsearched the reference lists of relevant articles and contacted experts in the field to request additional data.\nSelection criteria\nIncluded studies were randomised controlled trials (RCTs) of premenopausal women with fibroids who were treated for at least three months with a SPRM.\nData collection and analysis\nTwo review authors independently reviewed all eligible studies identified by the search. We extracted data and assessed risk of bias independently using standard forms. We analysed data using mean differences (MDs) or standardised mean differences (SMDs) for continuous data and odds ratios (ORs) for dichotomous data. We performed meta-analyses using the random-effects model. Our primary outcome was change in fibroid-related symptoms.\nMain results\nWe included in the review 14 RCTs with a total of 1215 study participants. We could not extract complete data from three studies. We included in the meta-analysis 11 studies involving 1021 study participants: 685 received SPRMs and 336 were given a control intervention (placebo or leuprolide). Investigators evaluated three SPRMs: mifepristone (five studies), ulipristal acetate (four studies) and asoprisnil (two studies). The primary outcome was change in fibroid-related symptoms (symptom severity, health-related quality of life, abnormal uterine bleeding, pelvic pain). Adverse event reporting in the included studies was limited to SPRM-associated endometrial changes. More than half (8/14) of these studies were at low risk of bias in all domains. The most common limitation of the other studies was poor reporting of methods. The main limitation for the overall quality of evidence was potential publication bias.\nSPRM versus placebo\nSPRM treatment resulted in improvements in fibroid symptom severity (MD -20.04 points, 95% confidence interval (CI) -26.63 to -13.46; four RCTs, 171 women, I2 = 0%; moderate-quality evidence) and health-related quality of life (MD 22.52 points, 95% CI 12.87 to 32.17; four RCTs, 200 women, I2 = 63%; moderate-quality evidence) on the Uterine Fibroid Symptom Quality of Life Scale (UFS-QoL, scale 0 to 100). Women treated with an SPRM showed reduced menstrual blood loss on patient-reported bleeding scales, although this effect was small (SMD -1.11, 95% CI -1.38 to -0.83; three RCTs, 310 women, I2 = 0%; moderate-quality evidence), along with higher rates of amenorrhoea (29 per 1000 in the placebo group vs 237 to 961 per 1000 in the SPRM group; OR 82.50, 95% CI 37.01 to 183.90; seven RCTs, 590 women, I2 = 0%; moderate-quality evidence), compared with those given placebo. We could draw no conclusions regarding changes in pelvic pain owing to variability in the estimates. With respect to adverse effects, SPRM-associated endometrial changes were more common after SPRM therapy than after placebo (OR 15.12, 95% CI 6.45 to 35.47; five RCTs, 405 women, I2 = 0%; low-quality evidence).\nSPRM versus leuprolide acetate\nIn comparing SPRM versus other treatments, two RCTs evaluated SPRM versus leuprolide acetate. One RCT reported primary outcomes. No evidence suggested a difference between SPRM and leuprolide groups for improvement in quality of life, as measured by UFS-QoL fibroid symptom severity scores (MD -3.70 points, 95% CI -9.85 to 2.45; one RCT, 281 women; moderate-quality evidence) and health-related quality of life scores (MD 1.06 points, 95% CI -5.73 to 7.85; one RCT, 281 women; moderate-quality evidence). It was unclear whether results showed a difference between SPRM and leuprolide groups for reduction in menstrual blood loss based on the pictorial blood loss assessment chart (PBAC), as confidence intervals were wide (MD 6 points, 95% CI -40.95 to 50.95; one RCT, 281 women; low-quality evidence), or for rates of amenorrhoea (804 per 1000 in the placebo group vs 732 to 933 per 1000 in the SPRM group; OR 1.14, 95% CI 0.60 to 2.16; one RCT, 280 women; moderate-quality evidence). No evidence revealed differences between groups in pelvic pain scores based on the McGill Pain Questionnaire (scale 0 to 45) (MD -0.01 points, 95% CI -2.14 to 2.12; 281 women; moderate-quality evidence). With respect to adverse effects, SPRM-associated endometrial changes were more common after SPRM therapy than after leuprolide treatment (OR 10.45, 95% CI 5.38 to 20.33; 301 women; moderate-quality evidence).\nAuthors' conclusions\nShort-term use of SPRMs resulted in improved quality of life, reduced menstrual bleeding and higher rates of amenorrhoea than were seen with placebo. Thus, SPRMs may provide effective treatment for women with symptomatic fibroids. Evidence derived from one RCT showed no difference between leuprolide acetate and SPRM with respect to improved quality of life and bleeding symptoms. Evidence was insufficient to show whether effectiveness was different between SPRMs and leuprolide. Investigators more frequently observed SPRM-associated endometrial changes in women treated with SPRMs than in those treated with placebo or leuprolide acetate. As noted above, SPRM-associated endometrial changes are benign, are not related to cancer and are not precancerous. Reporting bias may impact the conclusion of this meta-analysis. Well-designed RCTs comparing SPRMs versus other treatments are needed.\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 the literature up to May 2016."
}
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query-laysum | 4559 | [
{
"role": "user",
"content": "Abstract: Background\nAlopecia areata is an autoimmune disease leading to nonscarring hair loss on the scalp or body. There are different treatments including immunosuppressants, hair growth stimulants, and contact immunotherapy.\nObjectives\nTo assess the benefits and harms of the treatments for alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) in children and adults.\nSearch methods\nThe Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP were searched up to July 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated classical immunosuppressants, biologics, small molecule inhibitors, contact immunotherapy, hair growth stimulants, and other therapies in paediatric and adult populations with AA.\nData collection and analysis\nWe used the standard procedures expected by Cochrane including assessment of risks of bias using RoB2 and the certainty of the evidence using GRADE. The primary outcomes were short-term hair regrowth ≥ 75% (between 12 and 26 weeks of follow-up), and incidence of serious adverse events. The secondary outcomes were long-term hair regrowth ≥ 75% (greater than 26 weeks of follow-up) and health-related quality of life. We could not perform a network meta-analysis as very few trials compared the same treatments. We presented direct comparisons and made a narrative description of the findings.\nMain results\nWe included 63 studies that tested 47 different treatments in 4817 randomised participants. All trials used a parallel-group design except one that used a cross-over design. The mean sample size was 78 participants. All trials recruited outpatients from dermatology clinics. Participants were between 2 and 74 years old. The trials included patients with AA (n = 25), AT (n = 1), AU (n = 1), mixed cases (n = 31), and unclear types of alopecia (n = 4).\nThirty-three out of 63 studies (52.3%) reported the proportion of participants achieving short-term hair regrowth ≥ 75% (between 12 and 26 weeks). Forty-seven studies (74.6%) reported serious adverse events and only one study (1.5%) reported health-related quality of life. Five studies (7.9%) reported the proportion of participants with long-term hair regrowth ≥ 75% (greater than 26 weeks).\nAmongst the variety of interventions found, we prioritised some groups of interventions for their relevance to clinical practice: systemic therapies (classical immunosuppressants, biologics, and small molecule inhibitors), and local therapies (intralesional corticosteroids, topical small molecule inhibitors, contact immunotherapy, hair growth stimulants and cryotherapy).\nConsidering only the prioritised interventions, 14 studies from 12 comparisons reported short-term hair regrowth ≥ 75% and 22 studies from 10 comparisons reported serious adverse events (18 reported zero events and 4 reported at least one). One study (1 comparison) reported quality of life, and two studies (1 comparison) reported long-term hair regrowth ≥ 75%.\nFor the main outcome of short-term hair regrowth ≥ 75%, the evidence is very uncertain about the effect of oral prednisolone or cyclosporine versus placebo (RR 4.68, 95% CI 0.57 to 38.27; 79 participants; 2 studies; very low-certainty evidence), intralesional betamethasone or triamcinolone versus placebo (RR 13.84, 95% CI 0.87 to 219.76; 231 participants; 1 study; very low-certainty evidence), oral ruxolitinib versus oral tofacitinib (RR 1.08, 95% CI 0.77 to 1.52; 80 participants; 1 study; very low-certainty evidence), diphencyprone or squaric acid dibutil ester versus placebo (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very-low-certainty evidence), diphencyprone or squaric acid dibutyl ester versus topical minoxidil (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very low-certainty evidence), diphencyprone plus topical minoxidil versus diphencyprone (RR 0.67, 95% CI 0.13 to 3.44; 30 participants; 1 study; very low-certainty evidence), topical minoxidil 1% and 2% versus placebo (RR 2.31, 95% CI 1.34 to 3.96; 202 participants; 2 studies; very low-certainty evidence) and cryotherapy versus fractional CO2 laser (RR 0.31, 95% CI 0.11 to 0.86; 80 participants; 1 study; very low-certainty evidence). The evidence suggests oral betamethasone may increase short-term hair regrowth ≥ 75% compared to prednisolone or azathioprine (RR 1.67, 95% CI 0.96 to 2.88; 80 participants; 2 studies; low-certainty evidence). There may be little to no difference between subcutaneous dupilumab and placebo in short-term hair regrowth ≥ 75% (RR 3.59, 95% CI 0.19 to 66.22; 60 participants; 1 study; low-certainty evidence) as well as between topical ruxolitinib and placebo (RR 5.00, 95% CI 0.25 to 100.89; 78 participants; 1 study; low-certainty evidence). However, baricitinib results in an increase in short-term hair regrowth ≥ 75% when compared to placebo (RR 7.54, 95% CI 3.90 to 14.58; 1200 participants; 2 studies; high-certainty evidence).\nFor the incidence of serious adverse events, the evidence is very uncertain about the effect of topical ruxolitinib versus placebo (RR 0.33, 95% CI 0.01 to 7.94; 78 participants; 1 study; very low-certainty evidence). Baricitinib and apremilast may result in little to no difference in the incidence of serious adverse events versus placebo (RR 1.47, 95% CI 0.60 to 3.60; 1224 participants; 3 studies; low-certainty evidence). The same result is observed for subcutaneous dupilumab compared to placebo (RR 1.54, 95% CI 0.07 to 36.11; 60 participants; 1 study; low-certainty evidence).\nFor health-related quality of life, the evidence is very uncertain about the effect of oral cyclosporine compared to placebo (MD 0.01, 95% CI -0.04 to 0.07; very low-certainty evidence).\nBaricitinib results in an increase in long-term hair regrowth ≥ 75% compared to placebo (RR 8.49, 95% CI 4.70 to 15.34; 1200 participants; 2 studies; high-certainty evidence).\nRegarding the risk of bias, the most relevant issues were the lack of details about randomisation and allocation concealment, the limited efforts to keep patients and assessors unaware of the assigned intervention, and losses to follow-up.\nAuthors' conclusions\nWe found that treatment with baricitinib results in an increase in short- and long-term hair regrowth compared to placebo. Although we found inconclusive results for the risk of serious adverse effects with baricitinib, the reported small incidence of serious adverse events in the baricitinib arm should be balanced with the expected benefits. We also found that the impact of other treatments on hair regrowth is very uncertain. Evidence for health-related quality of life is still scant.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Baricitinib (an immunosuppressant medicine taken by mouth) compared to placebo increases hair regrowth ≥ 75% (both short and long-term) and we are confident with these results. The evidence is very uncertain about the effect of topical hair growth stimulants (minoxidil) on short-term hair regrowth ≥ 75% compared to placebo as the results largely varied from study to study. It is unclear if other treatments compared to placebo or to other medicines have an effect on hair regrowth, and we are not confident of the evidence because the results from the studies varied widely, and involved small numbers of people. Some studies did not clearly report how they were conducted, or whether the people taking part knew what they had received which could have affected the study's results. Further research is likely to change our results.\nFour studies that assessed the immunosuppressant drugs dupilumab (administered subcutaneously), baricitinib, and topical ruxolitinib reported 30 serious adverse events (23 in the treatment group and 7 in the placebo group) in a total of 1332 participants. In all cases, the authors did not establish a direct relationship between serious adverse events and therapies. There were no deaths, serious infections, or cancer cases. Based on the available evidence, those treatments may have little to no effect on serious adverse events.\nIt is unclear if oral cyclosporine (an immunosuppressant drug) has an effect on the quality of life."
}
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query-laysum | 4560 | [
{
"role": "user",
"content": "Abstract: Background\nBreast surgery encompasses oncologic, reconstructive, and cosmetic procedures. With the recent focus on the over-prescribing of opioids in the literature, it is important to assess the effectiveness and safety of non-opioid pain medication regimens including nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID pain medications. Clinicians have differing opinions on the safety of perioperative (relating to, occurring in, or being the period around the time of a surgical operation) NSAIDs for breast surgery given the unclear risk/benefit ratio. NSAIDs have been shown to decrease inflammation, pain, and fever, while potentially increasing the risks of bleeding complications.\nObjectives\nTo assess the effects of perioperative NSAID use versus non-NSAID analgesics (other pain medications) in women undergoing any form of breast surgery.\nSearch methods\nThe Cochrane Breast Information Specialist searched the Cochrane Breast Cancer Group (CBCG) Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, The WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to 21 September 2020. Full articles were retrieved for potentially eligible trials.\nSelection criteria\nWe considered all randomized controlled trials (RCTs) looking at perioperative NSAID use in women undergoing breast surgery.\nData collection and analysis\nTwo review authors independently screened studies, extracted data and assessed risk of bias, and certainty of the evidence using the GRADE approach. The main outcomes were incidence of breast hematoma within 90 days (requiring reoperation, interventional drainage, or no treatment) of breast surgery and pain intensity 24 hours following surgery, incidence rate or severity of postoperative nausea, vomiting or both, bleeding from any location within 90 days, need for blood transfusion, other side effects of NSAID use, opioid use within 24 hours of surgery, length of hospital stay, breast cancer recurrence, and non-prescribed NSAID use. Data were presented as risk ratios (RRs) for dichotomous outcomes and standardized mean differences (SMDs) for continuous outcomes.\nMain results\nWe included 12 RCTs with a total of 1596 participants. Seven studies compared NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib) to placebo. Four studies compared NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib) to other analgesics (morphine, hydrocodone, hydromorphone, fentanyl). One study compared NSAIDs (diclofenac) to no intervention.\nNSAIDs compared to placebo\nMost outcomes are judged to have low-certainty evidence unless stated otherwise. There may be little to no difference in the incidence of breast hematomas within 90 days of breast surgery (RR 0.33, 95% confidence interval (CI) 0.05 to 2.02; 2 studies, 230 participants; I2 = 0%). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I2 = 73%). There may be little to no difference in the incidence rates or severities of postoperative nausea, vomiting, or both (RR 1.15, 95% CI 0.58 to 2.27; 4 studies, 939 participants; I2 = 81%), bleeding from any location within 90 days (RR 1.05, 95% CI 0.89 to 1.24; 2 studies, 251 participants; I2 = 8%), or need for blood transfusion compared to placebo groups, but we are very uncertain (RR 4.62, 95% CI 0.23 to 91.34; 1 study, 48 participants; very low-certainty evidence). There may be no difference in other side effects (RR 1.12, 95% CI 0.44 to 2.86; 2 studies, 251 participants; I2 = 0%). NSAIDs may reduce opioid use within 24 hours of surgery compared to placebo (SMD -0.45, 95% CI -0.85 to -0.05; 4 studies, 304 participants; I2 = 63%).\nNSAIDs compared to other analgesics\nThere is little to no difference in the incidence of breast hematomas within 90 days of breast surgery, but we are very uncertain (RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; very low-certainty evidence). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery (SMD -0.68, 95% CI -0.97 to -0.39; 3 studies, 200 participants; I2 = 89%; low-certainty evidence) and probably reduce the incidence rates or severities of postoperative nausea, vomiting, or both compared to other analgesics (RR 0.18, 95% CI 0.06 to 0.57; 3 studies, 128 participants; I2 = 0%; moderate-certainty evidence). There is little to no difference in the development of bleeding from any location within 90 days of breast surgery or in other side effects, but we are very uncertain (bleeding: RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; other side effects: RR 0.11, 95% CI 0.01 to 1.80; 1 study, 48 participants; very low-certainty evidence). NSAIDs may reduce opioid use within 24 hours of surgery compared to other analgesics (SMD -6.87, 95% CI -10.93 to -2.81; 3 studies, 178 participants; I2 = 96%; low-certainty evidence).\nNSAIDs compared to no intervention\nThere is little to no difference in pain intensity 24 (± 12) hours following surgery compared to no intervention, but we are very uncertain (SMD -0.54, 95% CI -1.09 to 0.00; 1 study, 60 participants; very low-certainty evidence).\nAuthors' conclusions\nLow-certainty evidence suggests that NSAIDs may reduce postoperative pain, nausea and vomiting, and postoperative opioid use. However, there was very little evidence to indicate whether NSAIDs affect the rate of breast hematoma or bleeding from any location within 90 days of breast surgery, the need for blood transfusion and incidence of other side effects compared to placebo or other analgesics. High-quality large-scale RCTs are required before definitive conclusions can be made.\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 found 12 studies with a total of 1596 participants. The evidence is current to September 2020. Seven studies compared NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib) to placebo. Four studies compared NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib) to other pain medications. One study compared NSAIDs (diclofenac) to no medication."
}
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query-laysum | 4561 | [
{
"role": "user",
"content": "Abstract: Background\nEczema and food allergy are common health conditions that usually begin in early childhood and often occur in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective for preventing eczema or food allergy.\nObjectives\nPrimary objective\nTo assess the effects of skin care interventions such as emollients for primary prevention of eczema and food allergy in infants.\nSecondary objective\nTo identify features of study populations such as age, hereditary risk, and adherence to interventions that are associated with the greatest treatment benefit or harm for both eczema and food allergy.\nSearch methods\nWe performed an updated search of the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase in September 2021. We searched two trials registers in July 2021. We checked the reference lists of included studies and relevant systematic reviews, and scanned conference proceedings to identify further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe included RCTs of skin care interventions that could potentially enhance skin barrier function, reduce dryness, or reduce subclinical inflammation in healthy term (> 37 weeks) infants (≤ 12 months) without pre-existing eczema, food allergy, or other skin condition. Eligible comparisons were standard care in the locality or no treatment. Types of skin care interventions could include moisturisers/emollients; bathing products; advice regarding reducing soap exposure and bathing frequency; and use of water softeners. No minimum follow-up was required.\nData collection and analysis\nThis is a prospective individual participant data (IPD) meta-analysis. We used standard Cochrane methodological procedures, and primary analyses used the IPD dataset. Primary outcomes were cumulative incidence of eczema and cumulative incidence of immunoglobulin (Ig)E-mediated food allergy by one to three years, both measured at the closest available time point to two years. Secondary outcomes included adverse events during the intervention period; eczema severity (clinician-assessed); parent report of eczema severity; time to onset of eczema; parent report of immediate food allergy; and allergic sensitisation to food or inhalant allergen.\nMain results\nWe identified 33 RCTs comprising 25,827 participants. Of these, 17 studies randomising 5823 participants reported information on one or more outcomes specified in this review. We included 11 studies, randomising 5217 participants, in one or more meta-analyses (range 2 to 9 studies per individual meta-analysis), with 10 of these studies providing IPD; the remaining 6 studies were included in the narrative results only.\nMost studies were conducted at children's hospitals. Twenty-five studies, including all those contributing data to meta-analyses, randomised newborns up to age three weeks to receive a skin care intervention or standard infant skin care. Eight of the 11 studies contributing to meta-analyses recruited infants at high risk of developing eczema or food allergy, although the definition of high risk varied between studies. Durations of intervention and follow-up ranged from 24 hours to three years. All interventions were compared against no skin care intervention or local standard care. Of the 17 studies that reported information on our prespecified outcomes, 13 assessed emollients.\nWe assessed most of the evidence in the review as low certainty and had some concerns about risk of bias. A rating of some concerns was most often due to lack of blinding of outcome assessors or significant missing data, which could have impacted outcome measurement but was judged unlikely to have done so. We assessed the evidence for the primary food allergy outcome as high risk of bias due to the inclusion of only one trial, where findings varied based on different assumptions about missing data.\nSkin care interventions during infancy probably do not change the risk of eczema by one to three years of age (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.81 to 1.31; risk difference 5 more cases per 1000 infants, 95% CI 28 less to 47 more; moderate-certainty evidence; 3075 participants, 7 trials) or time to onset of eczema (hazard ratio 0.86, 95% CI 0.65 to 1.14; moderate-certainty evidence; 3349 participants, 9 trials). Skin care interventions during infancy may increase the risk of IgE-mediated food allergy by one to three years of age (RR 2.53, 95% CI 0.99 to 6.49; low-certainty evidence; 976 participants, 1 trial) but may not change risk of allergic sensitisation to a food allergen by age one to three years (RR 1.05, 95% CI 0.64 to 1.71; low-certainty evidence; 1794 participants, 3 trials). Skin care interventions during infancy may slightly increase risk of parent report of immediate reaction to a common food allergen at two years (RR 1.27, 95% CI 1.00 to 1.61; low-certainty evidence; 1171 participants, 1 trial); however, this was only seen for cow’s milk, and may be unreliable due to over-reporting of milk allergy in infants. Skin care interventions during infancy probably increase risk of skin infection over the intervention period (RR 1.33, 95% CI 1.01 to 1.75; risk difference 17 more cases per 1000 infants, 95% CI one more to 38 more; moderate-certainty evidence; 2728 participants, 6 trials) and may increase the risk of infant slippage over the intervention period (RR 1.42, 95% CI 0.67 to 2.99; low-certainty evidence; 2538 participants, 4 trials) and stinging/allergic reactions to moisturisers (RR 2.24, 95% 0.67 to 7.43; low-certainty evidence; 343 participants, 4 trials), although CIs for slippages and stinging/allergic reactions were wide and include the possibility of no effect or reduced risk.\nPreplanned subgroup analyses showed that the effects of interventions were not influenced by age, duration of intervention, hereditary risk, filaggrin (FLG) mutation, chromosome 11 intergenic variant rs2212434, or classification of intervention type for risk of developing eczema. We could not evaluate these effects on risk of food allergy. Evidence was insufficient to show whether adherence to interventions influenced the relationship between skin care interventions and eczema or food allergy development.\nAuthors' conclusions\nBased on low- to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection. Further study is needed to understand whether different approaches to infant skin care might prevent eczema or food allergy.\n\nGiven the provided abstract, please respond to the following query: \"Food allergies and eczema\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Eczema is a common skin condition that causes dry, itchy, cracked skin. Eczema is common in children, often developing before their first birthday, and may be long-lasting.\nAllergies to food can cause itching in the mouth, a raised itchy red rash, swelling of the face, stomach symptoms, or difficulty breathing. They usually happen within two hours after a food is eaten.\nPeople with food allergies often have other allergic conditions, such as asthma, hay fever, and eczema."
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query-laysum | 4562 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with asthma who come from minority groups often have poorer asthma outcomes, including more acute asthma-related doctor visits for flare-ups. Various programmes used to educate and empower people with asthma have previously been shown to improve certain asthma outcomes (e.g. adherence outcomes, asthma knowledge scores in children and parents, and cost-effectiveness). Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual, and not just the symptoms of the disease. Therefore, questions about whether tailoring asthma education programmes that are culturally specific for people from minority groups are effective at improving asthma-related outcomes, that are feasible and cost-effective need to be answered.\nObjectives\nTo determine whether culture-specific asthma education programmes, in comparison to generic asthma education programmes or usual care, improve asthma-related outcomes in children and adults with asthma who belong to minority groups.\nSearch methods\nWe searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, Embase, review articles and reference lists of relevant articles. The latest search fully incorporated into the review was performed in June 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups with asthma.\nData collection and analysis\nTwo review authors independently selected, extracted and assessed the data for inclusion. We contacted study authors for further information if required.\nMain results\nIn this review update, an additional three studies and 220 participants were added. A total of seven RCTs (two in adults, four in children, one in both children and adults) with 837 participants (aged from one to 63 years) with asthma from ethnic minority groups were eligible for inclusion in this review. The methodological quality of studies ranged from very low to low. For our primary outcome (asthma exacerbations during follow-up), the quality of evidence was low for all outcomes. In adults, use of a culture-specific programme, compared to generic programmes or usual care did not significantly reduce the number of participants from two studies with 294 participants for: exacerbations with one or more exacerbations during follow-up (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.50 to 1.26), hospitalisations over 12 months (OR 0.83, 95% CI 0.31 to 2.22) and exacerbations requiring oral corticosteroids (OR 0.97, 95% CI 0.55 to 1.73). However, use of a culture-specific programme, improved asthma quality of life scores in 280 adults from two studies (mean difference (MD) 0.26, 95% CI 0.17 to 0.36) (although the MD was less then the minimal important difference for the score). In children, use of a culture-specific programme was superior to generic programmes or usual care in reducing severe asthma exacerbations requiring hospitalisation in two studies with 305 children (rate ratio 0.48, 95% CI 0.24 to 0.95), asthma control in one study with 62 children and QoL in three studies with 213 children, but not for the number of exacerbations during follow-up (OR 1.55, 95% CI 0.66 to 3.66) or the number of exacerbations (MD 0.18, 95% CI -0.25 to 0.62) among 100 children from two studies.\nAuthors' conclusions\nThe available evidence showed that culture-specific education programmes for adults and children from minority groups are likely effective in improving asthma-related outcomes. This review was limited by few studies and evidence of very low to low quality. Not all asthma-related outcomes improved with culture-specific programs for both adults and children. Nevertheless, while modified culture-specific education programs are usually more time intensive, the findings of this review suggest using culture-specific asthma education programmes for children and adults from minority groups. However, more robust RCTs are needed to further strengthen the quality of evidence and determine the cost-effectiveness of culture-specific programs.\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": "Do culture-specific asthma education programmes (compared to generic asthma education programmes or usual care) improve asthma-related outcomes in children and adults with asthma who belong to minority groups?"
}
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query-laysum | 4563 | [
{
"role": "user",
"content": "Abstract: Background\nTotal hip arthroplasty (THA) is one of the most common orthopaedic operations performed worldwide. Painful osteoarthritis of the hip is the primary indication for THA. Following THA, people have conventionally been provided with equipment, such as raised toilet seats and chairs, and educated to avoid activities that could cause the hip joint to be in a position of flexion over 90 degrees, or adduction or rotation past the midline. These aspects of occupational therapy have been advocated to reduce the risks of prosthesis dislocation. However, the appropriateness of these recommendations has been questioned.\nObjectives\nTo assess the effects of provision of assistive devices, education on hip precautions, environmental modifications and training in activities of daily living (ADL) and extended ADL (EADL) for people undergoing THA.\nSearch methods\nWe searched MEDLINE (1946 to April 2016), EMBASE (1947 to April 2016), the Cochrane Library including CENTRAL (Issue 4 of 12, 2016), Database of Reviews of Effects (DARE), Health Technology Assessment (HTA), Economic Evaluations Database (EED), CINAHL, PEDro and CIRRIE from inception to April 2016. In addition we checked Controlled Clinical Trials, Clinicaltrials.gov, the National Institutes of Health Trial Registry, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and the OpenGrey database from inception to April 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and cluster-RCTs that evaluated the effectiveness of the provision of assistive devices, education on hip precautions, environmental modifications, or training in ADL and EADL for people undergoing THA. The main outcomes of interest were pain, function, health-related quality of life (HRQOL), global assessment of treatment success, reoperation rate, hip dislocation and adverse events.\nData collection and analysis\nWe used standard methodological procedures recognised by Cochrane. We conducted a systematic literature search using several databases and contacted corresponding authors, appraised the evidence using the Cochrane risk of bias tool, analysed the data using a narrative analysis approach (as it was not possible to conduct a meta-analysis due to heterogeneity in interventions), and interpreted all outcomes using the GRADE approach.\nMain results\nWe included three trials with a total of 492 participants who had received 530 THA. The evidence presented with a high risk of performance, detection and reporting bias.\nOne study (81 participants) compared outcomes for participants randomised to the provision of hip precautions, equipment and functional restrictions versus no provision of hip precautions, equipment or functional restrictions. Due to the quality of evidence being very low, we are uncertain if the provision of hip precautions, equipment and functional restrictions improved function measured using the Harris Hip Score at 12 month follow-up, or health-related quality of life (HRQOL) measured by the Short Form-12 at four week follow-up, compared to not providing this. There were no incidences of hip dislocation or adverse events in either group during the initial 12 postoperative months. The study did not measure pain score, global assessment of treatment success or total adverse events.\nOne study (265 participants; 303 THAs) evaluated the provision of hip precautions with versus without the prescription of postoperative equipment and restrictions to functional activities. Due to the quality of evidence being very low, we are uncertain if perceived satisfaction in the rate of recovery differed in people who were not prescribed postoperative equipment and restrictions (135/151 satisfied) compared to those prescribed equipment and restrictions (113/152) (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.75 to 0.93; 265 participants, one trial; number needed to treat for an additional beneficial outcome (NNTB) = 7). Due to the low quality evidence, we are uncertain if the incidence of hip dislocation differed between participants provided with hip precautions with (1/152) compared to without providing equipment or restrictions post-THA (0/151) (RR 2.98, 95% CI 0.12 to 72.59). The study did not measure pain, function, HRQOL, re-operation rates or total adverse events.\nOne study (146 participants) investigated the provision of an enhanced postoperative education and rehabilitation service on hospital discharge to promote functional ADL versus a conventional rehabilitation intervention in the community. This study was of very low quality evidence. We were uncertain if the provision of enhanced postoperative education and rehabilitation improved function at six months follow-up, when assessed using the Objective and Subjective Functional Capability Index (146 participants, one trial; P > 0.05; no numerical results provided) compared to conventional rehabilitation. The study did not measure pain score, HRQOL, global assessment of treatment success, hip dislocation, re-operation rate or total adverse events.\nAuthors' conclusions\nVery low quality evidence is available from single trials, thus we are uncertain if hip precautions with or without the addition of equipment and functional restrictions are effective in preventing dislocation and improving outcomes after THA. There is also insufficient evidence to support or refute the adoption of a postoperative community rehabilitation programme consisting of functional reintegration and education compared to conventional rehabilitation strategies based on functional outcomes.\nFurther high-quality trials are warranted to assess the outcomes of different occupational therapy interventions both in the short and longer-term for those who undergo THA. An assessment of the impact of such interventions on pain and restriction on personal ADL, EADL and instrumental ADL is needed, and also of functional integration-type interventions rather than just hip precautions, equipment and restrictions.\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": "Total hip arthroplasty (THA) is a common surgical procedure for the treatment of pain and disability cause by osteoarthritis. Following THA, people have usually been provided with equipment, such as raised toilet seats and chairs, and educated to avoid activities that could cause the hip joint to be in a position of bending, twisting or where people cross their legs. These interventions aim to reduce the chances of dislocating the new hip, which is a painful and disabling event. This advice and equipment provision is often led by occupational therapists after a THA. We wanted to find out whether these types of treatments improve a person's recovery following a THA."
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query-laysum | 4564 | [
{
"role": "user",
"content": "Abstract: Background\nHyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for hospitalization during pregnancy. While a previous Cochrane review examined interventions for nausea and vomiting in pregnancy, there has not yet been a review examining the interventions for the more severe condition of hyperemesis gravidarum.\nObjectives\nTo assess the effectiveness and safety, of all interventions for hyperemesis gravidarum in pregnancy up to 20 weeks' gestation.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register and the Cochrane Complementary Medicine Field's Trials Register (20 December 2015) and reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials of any intervention for hyperemesis gravidarum. Quasi-randomized trials and trials using a cross-over design were not eligible for inclusion.\nWe excluded trials on nausea and vomiting of pregnancy that were not specifically studying the more severe condition of hyperemesis gravidarum.\nData collection and analysis\nTwo review authors independently reviewed the eligibility of trials, extracted data and evaluated the risk of bias. Data were checked for accuracy.\nMain results\nTwenty-five trials (involving 2052 women) met the inclusion criteria but the majority of 18 different comparisons described in the review include data from single studies with small numbers of participants. The comparisons covered a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various pharmaceutical interventions. The methodological quality of included studies was mixed. For selected important comparisons and outcomes, we graded the quality of the evidence and created 'Summary of findings' tables. For most outcomes the evidence was graded as low or very low quality mainly due to the imprecision of effect estimates. Comparisons included in the 'Summary of findings' tables are described below, the remaining comparisons are described in detail in the main text.\nNo primary outcome data were available when acupuncture was compared with placebo, There was no clear evidence of differences between groups for anxiodepressive symptoms (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.40; one study, 36 women, very low-quality evidence), spontaneous abortion (RR 0.48, 95% CI 0.05 to 5.03; one study, 57 women, low-quality evidence), preterm birth (RR 0.12, 95% CI 0.01 to 2.26; one study, 36 women, low-quality evidence), or perinatal death (RR 0.57, 95% CI 0.04 to 8.30; one study, 36 women, low-quality evidence).\nThere was insufficient evidence to identify clear differences between acupuncture and metoclopramide in a study with 81 participants regarding reduction/cessation in nausea or vomiting (RR 1.40, 95% CI 0.79 to 2.49 and RR 1.51, 95% CI 0.92 to 2.48, respectively; very low-quality evidence).\nIn a study with 92 participants, women taking vitamin B6 had a slightly longer hospital stay compared with placebo (mean difference (MD) 0.80 days, 95% CI 0.08 to 1.52, moderate-quality evidence). There was insufficient evidence to demonstrate a difference in other outcomes including mean number of episodes of emesis (MD 0.50, 95% CI -0.40 to 1.40, low-quality evidence) or side effects.\nA comparison between metoclopramide and ondansetron identified no clear difference in the severity of nausea or vomiting (MD 1.70, 95% CI -0.15 to 3.55, and MD -0.10, 95% CI -1.63 to 1.43; one study, 83 women, respectively, very low-quality evidence). However, more women taking metoclopramide complained of drowsiness and dry mouth (RR 2.40, 95% CI 1.23 to 4.69, and RR 2.38, 95% CI 1.10 to 5.11, respectively; moderate-quality evidence). There were no clear differences between groups for other side effects.\nIn a single study with 146 participants comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness, dizziness, and dystonia (RR 0.70, 95% CI 0.56 to 0.87, RR 0.48, 95% CI 0.34 to 0.69, and RR 0.31, 95% CI 0.11 to 0.90, respectively, moderate-quality evidence). There were no clear differences between groups for other important outcomes including quality of life and other side effects.\nIn a single trial with 30 women, those receiving ondansetron had no difference in duration of hospital admission compared to those receiving promethazine (MD 0.00, 95% CI -1.39 to 1.39, very low-quality evidence), although there was increased sedation with promethazine (RR 0.06, 95% CI 0.00 to 0.94, low-quality evidence) .\nRegarding corticosteroids, in a study with 110 participants there was no difference in days of hospital admission compared to placebo (MD -0.30, 95% CI -0.70 to 0.10; very low-quality evidence), but there was a decreased readmission rate (RR 0.69, 95% CI 0.50 to 0.94; four studies, 269 women). For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, there was insufficient evidence to identify differences between groups (very low-quality evidence for all outcomes). In other single studies there were no clear differences between groups for preterm birth or side effects (very low-quality evidence).\nFor hydrocortisone compared with metoclopramide, no data were available for primary outcomes and there was no difference in the readmission rate (RR 0.08, 95% CI 0.00 to 1.28;one study, 40 women).\nIn a study with 80 women, compared to promethazine, those receiving prednisolone had increased nausea at 48 hours (RR 2.00, 95% CI 1.08 to 3.72; low-quality evidence), but not at 17 days (RR 0.81, 95% CI 0.58 to 1.15, very low-quality evidence). There was no clear difference in the number of episodes of emesis or subjective improvement in nausea/vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth.\nAuthors' conclusions\nOn the basis of this review, there is little high-quality and consistent evidence supporting any one intervention, which should be taken into account when making management decisions. There was also very limited reporting on the economic impact of hyperemesis gravidarum and the impact that interventions may have.\nThe limitations in interpreting the results of the included studies highlights the importance of consistency in the definition of hyperemesis gravidarum, the use of validated outcome measures, and the need for larger placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Given that there was little evidence to support the superiority of one intervention over another in the treatment of hyperemesis, larger controlled trials are needed on these therapies. More research should be done comparing the side effects and safety, as well as the economic costs and benefits of these interventions to aid in the selection of the optimal treatment.\nReporting on adverse maternal and infant outcomes was limited and we did not find any studies on dietary or other lifestyle interventions.\n"
}
]
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query-laysum | 4565 | [
{
"role": "user",
"content": "Abstract: Background\nCroup is an acute viral respiratory infection with upper airway mucosal inflammation that may cause respiratory distress. Most cases are mild. Moderate to severe croup may require treatment with corticosteroids (the benefits of which are often delayed) and nebulised epinephrine (adrenaline) (the benefits of which may be short-lived and which can cause dose-related adverse effects including tachycardia, arrhythmias, and hypertension). Rarely, croup results in respiratory failure necessitating emergency intubation and ventilation.\nA mixture of helium and oxygen (heliox) may prevent morbidity and mortality in ventilated neonates by reducing the viscosity of the inhaled air. It is currently used during emergency transport of children with severe croup. Anecdotal evidence suggests that it relieves respiratory distress.\nThis review updates versions published in 2010, 2013, and 2018.\nObjectives\nTo examine the effect of heliox compared to oxygen or other active interventions, placebo, or no treatment on relieving signs and symptoms in children with croup as determined by a croup score and rates of admission and intubation.\nSearch methods\nWe searched CENTRAL, which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE, Embase, CINAHL, Web of Science, and LILACS, on 15 April 2021. We also searched the World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch/) and ClinicalTrials.gov (clinicaltrials.gov) on 15 April 2021. We contacted the British Oxygen Company, a leading supplier of heliox.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing the effect of heliox in comparison with placebo, no treatment, or any active intervention(s) in children with croup.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Data that could not be pooled for statistical analysis were reported descriptively.\nMain results\nWe included 3 RCTs involving a total of 91 children aged between 6 months and 4 years. Study duration was from 7 to 16 months, and all studies were conducted in emergency departments. Two studies were conducted in the USA and one in Spain. Heliox was administered as a mixture of 70% heliox and 30% oxygen. Risk of bias was low in two studies and high in one study because of its open-label design. We did not identify any new trials for this 2021 update.\nOne study of 15 children with mild croup compared heliox with 30% humidified oxygen administered for 20 minutes. There may be no difference in croup score changes between groups at 20 minutes (mean difference (MD) −0.83, 95% confidence interval (CI) −2.36 to 0.70) (Westley croup score, scale range 0 to 16). The mean croup score at 20 minutes postintervention may not differ between groups (MD −0.57, 95% CI −1.46 to 0.32). There may be no difference between groups in mean respiratory rate (MD 6.40, 95% CI −1.38 to 14.18) and mean heart rate (MD 14.50, 95% CI −8.49 to 37.49) at 20 minutes. The evidence for all outcomes in this comparison was of low certainty, downgraded for serious imprecision. All children were discharged, but information on hospitalisation, intubation, or re-presenting to emergency departments was not reported.\nIn another study, 47 children with moderate croup received one dose of oral dexamethasone (0.3 mg/kg) with either heliox for 60 minutes or no treatment. Heliox may slightly improve Taussig croup scores (scale range 0 to 15) at 60 minutes postintervention (MD −1.10, 95% CI −1.96 to −0.24), but there may be no difference between groups at 120 minutes (MD −0.70, 95% CI −1.56 to 0.16). Children treated with heliox may have lower mean Taussig croup scores at 60 minutes (MD −1.11, 95% CI −2.05 to -0.17) but not at 120 minutes (MD −0.71, 95% CI −1.72 to 0.30). Children treated with heliox may have lower mean respiratory rates at 60 minutes (MD −4.94, 95% CI −9.66 to −0.22), but there may be no difference at 120 minutes (MD −3.17, 95% CI −7.83 to 1.49). There may be a difference in hospitalisation rates between groups (odds ratio 0.46, 95% CI 0.04 to 5.41). We assessed the evidence for all outcomes in this comparison as of low certainty, downgraded due to imprecision and high risk of bias related to an open-label design. Information on heart rate and intubation was not reported.\nIn the third study, 29 children with moderate to severe croup all received continuous cool mist and intramuscular dexamethasone (0.6 mg/kg). They were then randomised to receive either heliox (given as a mixture of 70% helium and 30% oxygen) plus one to two doses of nebulised saline or 100% oxygen plus nebulised epinephrine (adrenaline), with gas therapy administered continuously for three hours. Heliox may slightly improve croup scores at 90 minutes postintervention, but may result in little or no difference overall using repeated-measures analysis. We assessed the evidence for all outcomes in this comparison as of low certainty, downgraded due to high risk of bias related to inadequate reporting. Information on hospitalisation or re-presenting to the emergency department was not reported.\nThe included studies did not report on adverse events, intensive care admissions, or parental anxiety.\nWe could not pool the available data because each comparison included data from only one study.\nAuthors' conclusions\nGiven the very limited available evidence, uncertainty remains regarding the effectiveness and safety of heliox. Heliox may not be more effective than 30% humidified oxygen for children with mild croup, but may be beneficial in the short term for children with moderate croup treated with dexamethasone. The effect of heliox may be similar to 100% oxygen given with one or two doses of adrenaline. Adverse events were not reported, and it is unclear if these were monitored in the included studies. Adequately powered RCTs comparing heliox with standard treatments are needed to further assess the role of heliox in the treatment of children with moderate to severe croup.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence was low, as the trials included few children, and in one trial children, their families, and the doctors knew which treatment had been given."
}
]
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query-laysum | 4566 | [
{
"role": "user",
"content": "Abstract: Background\nMalignant gastric outlet obstruction is the clinical and pathological consequence of cancerous disease causing a mechanical obstruction to gastric emptying. It usually occurs when malignancy is at an advanced stage; therefore, people have a limited life expectancy. It is of paramount importance to restore oral intake to improve quality of life for the person in a manner that has a minimal risk of complications and a short recovery period.\nObjectives\nTo assess the benefits and harms of endoscopic stent placement versus surgical palliation for people with symptomatic malignant gastric outlet obstruction.\nSearch methods\nIn May 2018 we searched the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase and Ovid CINAHL. We screened reference lists from included studies and review articles.\nSelection criteria\nWe included randomised controlled trials comparing stent placement with surgical palliation for people with gastric outlet obstruction secondary to malignant disease.\nData collection and analysis\nTwo review authors independently extracted study data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for binary outcomes, mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes and the hazard ratio (HR) for time-to-event outcomes. We performed meta-analyses where meaningful. We assessed the quality of evidence using GRADE criteria.\nMain results\nWe identified three randomised controlled trials with 84 participants. Forty-one participants underwent surgical palliation and 43 participants underwent duodenal stent placement. There may have been little or no difference in the technical success of the procedure (RR 0.98, 95% CI 0.88 to 1.09; low-quality evidence), or whether the time to resumption of oral intake was quicker for participants who had undergone duodenal stent placement (MD -3.07 days, 95% CI -4.76 to -1.39; low-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved all-cause mortality and median survival postintervention.\nThe time to recurrence of obstructive symptoms may have increased slightly following duodenal stenting (RR 5.08, 95% CI 0.96 to 26.74; moderate-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved serious and minor adverse events. The heterogeneity for adverse events was moderately high (serious adverse events: Chi² = 1.71; minor adverse events: Chi² = 3.08), reflecting the differences in definitions used and therefore, may have impacted the outcomes. The need for reintervention may have increased following duodenal stenting (RR 4.71, 95% CI 1.36 to 16.30; very low-quality evidence).\nThe length of hospital stay may have been shorter (by approximately 4 to 10 days) following stenting (MD -6.70 days, 95% CI -9.41 to -3.98; moderate-quality evidence).\nAuthors' conclusions\nThe use of duodenal stent placement in malignant gastric outlet obstruction has the benefits of a quicker resumption of oral intake and a reduced inpatient hospital stay; however, this is balanced by an increase in the recurrence of symptoms and the need for further intervention.\nIt is impossible to draw further conclusions on these and the other measured outcomes, primarily due to the low number of eligible studies and small number of participants which resulted in low-quality evidence. It was not possible to analyse the impact on quality of life each intervention had for these participants.\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 studies included only a small number of participants and all studies were used slightly different methods, making it difficult to be certain of the key results."
}
]
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query-laysum | 4567 | [
{
"role": "user",
"content": "Abstract: Background\nDementia is a syndrome of acquired cognitive impairment which is severe enough to interfere with independent living. Over the course of the illness, people with dementia also experience changes in emotions, behaviour and social relationships. According to Alzheimer's Disease International, dementia affects approximately 55 million people worldwide. The latest NICE guideline for dementia highlights the value of diverse treatment options for the different stages and symptoms of dementia, including non-pharmacological treatments. Relevant literature also argues for the value of interventions that acknowledge the complexity of the condition and address the person as a whole, including their physical, emotional, social and cognitive processes. A growing literature highlights the capacity of the arts and has embodied practices to address this complexity. Dance movement therapy (DMT) is an embodied psychological intervention that can address complexity and thus may be useful for people with dementia, but its effectiveness remains unclear.\nObjectives\nTo assess the effects of dance movement therapy on behavioural, social, cognitive and emotional symptoms of people with dementia in comparison to no treatment, standard care or any other treatment. Also, to compare different forms of dance movement therapy (e.g. Laban-based dance movement therapy, Chacian dance movement therapy or Authentic Movement)\nSearch methods\nWe searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register of the International Clinical Trials Registry Portal until 8 December 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that included people with dementia, of any age and in any setting. The DMT intervention had to be delivered by a dance movement therapy practitioner who (i) had received formal training (ii) was a dance movement therapist in training or (iii) was otherwise recognised as a dance movement therapist in the country in which the study was conducted.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and evaluated methodological quality. We expressed effect estimates using the mean difference (MD) between intervention groups and presented associated confidence intervals (CIs). We used GRADE methods to rate our certainty in the results.\nMain results\nWe found only one study eligible for inclusion in this review. This was a 3-arm parallel-group RCT conducted in Hong Kong involving 204 adults with mild neurocognitive disorder or dementia. The study examined the effects of short-term (12 weeks) group DMT in comparison with exercise and a waiting-list control group immediately post-intervention and three and nine months later.\nWe found that, at the end of the intervention, DMT may result in little to no difference in neuropsychiatric symptoms assessed with the 12-item Neuropsychiatric Inventory when compared with waiting list (MD 0.3, 95% CI -0.96 to 1.56; low-certainty evidence) or exercise (MD -0.30, 95% CI -1.83 to 1.23; low-certainty evidence). Nor was there any evidence of effects at later time points.\nCognitive functioning was assessed with a variety of instruments and there were no statistically significant between-group differences (low-certainty evidence). When compared to exercise or waiting list, DMT may result in little to no difference in cognitive function immediately after the intervention or at follow-up.\nIn comparison to waiting list, DMT may result in a slight reduction in depression assessed with the 4-item Geriatric Depression Scale at the end of therapy (MD -0.60, 95% CI -0.96 to -0.24; low-certainty evidence). This slight positive effect of DMT on depression scores was sustained at three and nine months after the completion of the intervention. DMT may also reduce depression slightly in comparison with exercise at the end of therapy (MD -0.40, 95% CI -0.76 to -0.04, low-certainty evidence), an effect also sustained at three and nine months.\nOur fourth primary outcome, quality of life, was not assessed in the included study.\nThere were data for two of our secondary outcomes, social and occupational functioning and dropouts (which we used as a proxy for acceptability), but in both cases the evidence was of very low certainty and hence our confidence in the results was very low.\nFor all outcomes, we considered the certainty of the evidence in relation to our review objectives to be low or very low in GRADE terms due to indirectness (because not all participants in the included study had a diagnosis of dementia) and imprecision.\nAuthors' conclusions\nThis review included one RCT with a low risk of bias. Due to the low certainty of the evidence, the true effects of DMT as an intervention for dementia may be substantially different from those found. More RCTs are needed to determine with any confidence whether DMT has beneficial effects on dementia.\n\nGiven the provided abstract, please respond to the following query: \"How is dementia treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Dementia may be treated through drugs to reduce symptoms. However, there are also complex interventions that are starting to emerge that address the person as a whole. There is also a growing interest in the use of dance and other forms of the arts for people with dementia."
}
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query-laysum | 4568 | [
{
"role": "user",
"content": "Abstract: Background\nIntermittent preventive treatment could help prevent malaria in infants (IPTi) living in areas of moderate to high malaria transmission in sub-Saharan Africa. The World Health Organization (WHO) policy recommended IPTi in 2010, but its adoption in countries has been limited.\nObjectives\nTo evaluate the effects of intermittent preventive treatment (IPT) with antimalarial drugs to prevent malaria in infants living in malaria-endemic areas.\nSearch methods\nWe searched the following sources up to 3 December 2018: the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library), MEDLINE (PubMed), Embase (OVID), LILACS (Bireme), and reference lists of articles. We also searched the metaRegister of Controlled Trials (mRCT) and the WHO International Clinical Trials Registry Platform (ICTRP) portal for ongoing trials up to 3 December 2018.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared IPT to placebo or no intervention in infants (defined as young children aged between 1 to 12 months) in malaria-endemic areas.\nData collection and analysis\nThe primary outcome was clinical malaria (fever plus asexual parasitaemia). Two review authors independently assessed trials for inclusion, evaluated the risk of bias, and extracted data. We summarized dichotomous outcomes and count data using risk ratios (RR) and rate ratios respectively, and presented all measures with 95% confidence intervals (CIs). We extracted protective efficacy values and their 95% CIs; when an included trial did not report this data, we calculated these values from the RR or rate ratio with its 95% CI. Where appropriate, we combined data in meta-analyses and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 12 trials that enrolled 19,098 infants; all were conducted in sub-Saharan Africa. Three trials were cluster-RCTs. IPTi with sulfadoxine-pyrimethamine (SP) was evaluated in 10 trials from 1999 to 2013 (n = 15,256). Trials evaluating ACTs included dihydroartemisinin-piperaquine (1 trial, 147 participants; year 2013), amodiaquine-artesunate (1 study, 684 participants; year 2008), and SP-artesunate (1 trial, 676 participants; year 2008). The earlier studies evaluated IPTi with SP, and were conducted in Tanzania (in 1999 and 2006), Mozambique (2004), Ghana (2004 to 2005), Gabon (2005), Kenya (2008), and Mali (2009). One trial evaluated IPTi with amodiaquine in Tanzania (2000). Later studies included three conducted in Kenya (2008), Tanzania (2008), and Uganda (2013), evaluating IPTi in multiple trial arms that included artemisinin-based combination therapy (ACT).\nAlthough the effect size varied over time and between drugs, overall IPTi impacts on the incidence of clinical malaria overall, with a 30% reduction (rate ratio 0.70, 0.62 to 0.80; 10 studies, 10,602 participants). The effect of SP appeared to attenuate over time, with trials conducted after 2009 showing little or no effect of the intervention. IPTi with SP probably resulted in fewer episodes of clinical malaria (rate ratio 0.78, 0.69 to 0.88; 8 trials, 8774 participants, moderate-certainty evidence), anaemia (rate ratio 0.82, 0.68 to 0.98; 6 trials, 7438 participants, moderate-certainty evidence), parasitaemia (rate ratio 0.66, 0.56 to 0.79; 1 trial, 1200 participants, moderate-certainty evidence), and fewer hospital admissions (rate ratio 0.85, 0.78 to 0.93; 7 trials, 7486 participants, moderate-certainty evidence). IPTi with SP probably made little or no difference to all-cause mortality (risk ratio 0.93, 0.74 to 1.15; 9 trials, 14,588 participants, moderate-certainty evidence).\nSince 2009, IPTi trials have evaluated ACTs and indicate impact on clinical malaria and parasitaemia. A small trial of DHAP in 2013 shows substantive effects on clinical malaria (RR 0.42, 0.33 to 0.54; 1 trial, 147 participants, moderate-certainty evidence) and parasitaemia (moderate-certainty evidence).\nAuthors' conclusions\nIn areas of sub-Saharan Africa, giving antimalarial drugs known to be effective against the malaria parasite at the time to infants as IPT probably reduces the risk of clinical malaria, anaemia, and hospital admission. Evidence from SP studies over a 19-year period shows declining efficacy, which may be due to increasing drug resistance. Combinations with ACTs appear promising as suitable alternatives for IPTi.\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"
},
{
"role": "assistant",
"content": "The review authors searched for studies published up to 3 December 2018."
}
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query-laysum | 4569 | [
{
"role": "user",
"content": "Abstract: Background\nRetinoblastoma is the most common primary intraocular malignancy of childhood. Systemic chemotherapy is a common treatment for intraocular retinoblastoma, and laser treatment is used as adjuvant therapy during or immediately after chemotherapy courses in selected cases.\nObjectives\nTo compare the effectiveness and safety of adding focal laser therapy to systemically-delivered chemotherapy in treating intraocular retinoblastoma.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 9), MEDLINE Ovid (1946 to 20 October 2016), Embase Ovid (1980 to 20 October 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 20 October 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 20 October 2016, ClinicalTrials.gov (www.clinicaltrials.gov); searched 20 October 2016, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 20 October 2016. We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) of systemic chemotherapy with versus without adjuvant laser therapy for postequatorial retinoblastoma.\nData collection and analysis\nWe planned to use standard methodological procedures expected by Cochrane. We planned to meta-analyse the primary outcome, that is the proportion of eyes with recurrence of tumours within three years from treatment\nMain results\nNo studies met the inclusion criteria for this review.\nAuthors' conclusions\nNo evidence from randomised controlled trials was found to support or refute laser therapy in addition to systemic chemotherapy for postequatorial retinoblastoma.\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"
},
{
"role": "assistant",
"content": "The review authors searched for studies published up to 20 October 2016."
}
]
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query-laysum | 4570 | [
{
"role": "user",
"content": "Abstract: Background\nChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment.\nObjectives\nTo assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people.\nSearch methods\nWe searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections.\nData collection and analysis\nThree review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive.\nMain results\nTen trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality).\nAuthors' conclusions\nHome-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.\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 the available literature for trials in which people were invited either to collect specimens at home or to attend a clinic for collection of specimens. We found 10 relevant trials in total. Three trials (including 1566 people) provided data to assess the proportion of people who completed testing, diagnosis and treatment. All trials gave information about the percentages of people who took self-collected specimens for detection of chlamydia and gonorrhoea infections at home and those who took the test at a clinic. Nine studies reported percentages related to positive test results."
}
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query-laysum | 4571 | [
{
"role": "user",
"content": "Abstract: Background\nNon-tubal ectopic pregnancy is the implantation of an embryo at a site lying outside the uterine cavity or fallopian tubes. Sites include a caesarean scar, the cornua uteri, the ovary, the cervix, and the abdomen. There has been an increasing trend in the occurrence of these rare conditions, especially caesarean scar pregnancy (CSP).\nObjectives\nTo evaluate the clinical effectiveness and safety of surgery, medical treatment, and expectant management of non-tubal ectopic pregnancy in terms of fertility outcomes and complications.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization (WHO) search portal and nine other databases to 12 December 2019. We handsearched reference lists of articles retrieved and contacted experts in the field to obtain additional data.\nSelection criteria\nWe included randomized controlled trials (RCTs) published in all languages that examined the effects and safety of surgery, medical treatment, and expectant management of non-tubal ectopic pregnancy.\nData collection and analysis\nWe used Cochrane standard methodological procedures. Primary outcomes were treatment success and complications.\nMain results\nWe included five RCTs with 303 women, all reporting Caesarean scar pregnancy. Two compared uterine arterial embolization (UAE) or uterine arterial chemoembolization (UACE) plus methotrexate (MTX) versus systemic MTX and subsequent dilation and suction curettage; one compared UACE plus MTX versus ultrasonography-guided local MTX injection; and two compared suction curettage under hysteroscopy versus suction curettage under ultrasonography after UAE/UACE.\nThe quality of evidence ranged from moderate to very low. The main limitations were imprecision (small sample sizes and very wide confidence intervals (CI) for most analyses), multiple comparisons with a small number of trials, and insufficient data available to assess heterogeneity.\nUAE/UACE versus systemic MTX prior to suction curettage\nTwo studies reported this comparison. One compared UAE with systemic MTX and one compared UACE plus MTX versus systemic MTX, in both cases followed by a suction curettage.\nWe are uncertain whether UAE/UACE improved success rates after initial treatment (UAE: risk ratio (RR) 1.00, 95% CI 0.90 to 1.12; 1 RCT, 72 women; low-quality evidence; UACE: RR 0.87, 95% CI 0.54 to 1.38; 1 RCT, 28 women; low-quality evidence).\nWe are uncertain whether UAE/UACE reduced rates of complications (UAE: RR 0.47, 95% CI 0.13 to 1.75; 1 RCT, 72 women; low-quality evidence; UACE: RR 0.62, 95% CI 0.26 to 1.48; 1 RCT, 28 women; low-quality evidence).\nWe are uncertain whether UAE/UACE reduced adverse effects (UAE: RR 1.58, 95% CI 0.41 to 6.11; 1 RCT, 72 women; low-quality evidence; UACE: RR 1.16, 95% CI 0.32 to 4.24; 1 RCT, 28 women; low-quality evidence), and it was not obvious that the types of events had similar values to participants (e.g. fever versus vomiting).\nBlood loss was lower in UAE/UACE groups than systemic MTX groups (UAE: mean difference (MD) –378.70 mL, 95% CI –401.43 to –355.97; 1 RCT, 72 women; moderate-quality evidence; UACE: MD –879.00 mL, 95% CI –1135.23 to -622.77; 1 RCT, 28 women; moderate-quality evidence).\nData were not available on time to normalize β-human chorionic gonadotropin (β-hCG).\nUACE plus MTX versus ultrasonography-guided local MTX injection\nWe are uncertain whether UACE improved success rates after initial treatment (RR 0.95, 95% CI 0.56 to 1.60; 1 RCT, 45 women; very low-quality evidence).\nAdverse effects: the study reported the same number of failed treatments in each arm (RR 0.88, 95% CI 0.40 to 1.92; 1 RCT, 45 women).\nWe are uncertain whether UACE shortened the time to normalize β-hCG (MD 1.50 days, 95% CI –3.16 to 6.16; 1 RCT, 45 women; very low-quality evidence).\nData were not available for complications.\nSuction curettage under hysteroscopy versus under ultrasonography after UAE/UACE.\nTwo studies reported this comparison. One compared suction curettage under hysteroscopy versus under ultrasonography after UAE, and one compared these interventions after UACE.\nWe are uncertain whether suction curettage under hysteroscopy improved success rates after initial treatment (UAE: RR 0.91, 95% CI 0.81 to 1.03; 1 RCT, 66 women; very low-quality evidence; UACE: RR 1.02, 95% CI 0.96 to 1.09; 1 RCT, 92 women; low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy reduced rates of complications (UAE: RR 4.00, 95% CI 0.47 to 33.91; 1 RCT, 66 women; very low-quality evidence; UACE: RR 0.18, 95% CI 0.01 to 3.72; 1 RCT, 92 women; low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy reduced adverse effects (UAE: RR 3.09, 95% CI 0.12 to 78.70; 1 RCT, 66 women; very low-quality evidence; UACE: not estimable; 1 RCT, 92 women; very low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy shortened the time to normalize β-hCG (UAE: MD 4.03 days, 95% CI –1.79 to 9.85; 1 RCT, 66 women; very low-quality evidence; UACE: MD 0.84 days, 95% CI –1.90 to 3.58; 1 RCT, 92 women; low-quality evidence).\nNon-tubal ectopic pregnancy other than CSP\nNo studies reported on non-tubal ectopic pregnancies in locations other than on a caesarean scar.\nAuthors' conclusions\nFor Caesarean scar pregnancies (CSP) it is uncertain whether there is a difference in success rates, complications, or adverse events between UAE/UACE and administration of systemic MTX before suction curettage (low-quality evidence). Blood loss was lower if suction curettage is conducted after UAE/UACE than after administration of systemic MTX (moderate-quality evidence). It is uncertain whether there is a difference in treatment success rates, complications, adverse effects or time to normalize β-hCG between suction curettage under hysteroscopy and under ultrasonography (very low-quality evidence). There are no studies of non-tubal ectopic pregnancy other than CSP and RCTs for these types of pregnancy are unlikely.\n\nGiven the provided abstract, please respond to the following query: \"Caesarean scar pregnancy\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Two studies compared UAE/UACE with methotrexate (surgery) versus systemic (into a vein or muscle) methotrexate injection (medical treatment) following suction curettage. Evidence was insufficient for treatment success, complications, and side effects. Moderate-quality evidence showed that blood loss from the treatment in the surgery group was lower than in the medical treatment group.There were no data for time for β-hCG levels to return to normal.\nOne study compared UAE with local (into uterine artery) methotrexate injection (surgery) versus ultrasound-guided local methotrexate injection (medical treatment). Evidence was insufficient for treatment success and time for β-hCG levels to return to normal. The study reported the same number of failed treatments in each arm There were no data for complications or other side effects.\nTwo studies compared suction curettage under hysteroscopy (insertion of a narrow telescope with a light and camera at the end into the uterus) versus suction curettage under ultrasound after UAE/UACE with methotrexate. Evidence was insufficient for treatment success, complications, side effects, and time for β-hCG levels to return to normal."
}
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query-laysum | 4572 | [
{
"role": "user",
"content": "Abstract: Background\nHaemolytic uraemic syndrome (HUS) is a common cause of acquired kidney failure in children and rarely in adults. The most important risk factor for development of HUS is a gastrointestinal infection by Shiga toxin-producing Escherichia coli (STEC). This review addressed the interventions aimed at secondary prevention of HUS in patients with diarrhoea who were infected with a bacteria that increase the risk of HUS.\nObjectives\nOur objective was to evaluate evidence regarding secondary preventative strategies for HUS associated with STEC infections. In doing so, we sought to assess the effectiveness and safety of interventions as well as their potential to impact the morbidity and death associated with this condition.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 12 November 2020 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\nStudies were considered based on the methods, participants, and research goals. Only randomised controlled trials were considered eligible for inclusion. The participants of the studies were paediatric and adult patients with diarrhoeal illnesses due to STEC. The primary outcome of interest was incidence of HUS.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe identified four studies (536 participants) for inclusion that investigated four different interventions including antibiotics (trimethoprim-sulfamethoxazole), anti-Shiga toxin antibody-containing bovine colostrum, Shiga toxin binding agent (Synsorb Pk: a silicon dioxide-based agent), and a monoclonal antibody against Shiga toxin (urtoxazumab). The overall risk of bias was unclear for selection, performance and detection bias and low for attrition, reporting and other sources of bias.\nIt was uncertain if trimethoprim-sulfamethoxazole reduced the incidence of HUS compared to no treatment (47 participants: RR 0.57, 95% CI 0.11-2.81, very low certainty evidence). Adverse events relative to this review, need for acute dialysis, neurological complication and death were not reported.\nThere were no incidences of HUS in either the bovine colostrum group or the placebo group. It was uncertain if bovine colostrum caused more adverse events (27 participants: RR 0.92, 95% CI 0.42 to 2.03; very low certainty evidence). The need for acute dialysis, neurological complications or death were not reported.\nIt is uncertain whether Synsorb Pk reduces the incidence of HUS compared to placebo (353 participants: RR 0.93, 95% CI 0.39 to 2.22; very low certainty evidence). Adverse events relevant to this review, need for acute dialysis, neurological complications or death were not reported.\nOne study compared two doses of urtoxazumab (3.0 mg/kg and 1.0 mg/kg) to placebo. It is uncertain if either 3.0 mg/kg urtoxazumab (71 participants: RR 0.34, 95% CI 0.01 to 8.14) or 1.0 mg/kg urtoxazumab (74 participants: RR 0.95, 95% CI 0.79 to 1.13) reduced the incidence of HUS compared to placebo (very low certainty evidence). Low certainty evidence showed there may be little or no difference in the number of treatment-emergent adverse events with either 3.0 mg/kg urtoxazumab (71 participants: RR 1.00, 95% CI 0.84 to 1.18) or 1.0 mg/kg urtoxazumab (74 participants: RR 0.95, 95% CI 0.79 to 1.13) compared to placebo. There were 25 serious adverse events reported in 18 patients: 10 in the placebo group, and 9 and 6 serious adverse events in the 1.0 mg/kg and 3.0 mg/kg urtoxazumab groups, respectively. It is unclear how many patients experienced these adverse events in each group, and how many patients experienced more than one event. It is uncertain if either dose of urtoxazumab increased the risk of neurological complications or death (very low certainty evidence). Need for acute dialysis was not reported.\nAuthors' conclusions\nThe included studies assessed antibiotics, bovine milk, and Shiga toxin inhibitor (Synsorb Pk) and monoclonal antibodies (Urtoxazumab) against Shiga toxin for secondary prevention of HUS in patients with diarrhoea due to STEC. However, no firm conclusions about the efficacy of these interventions can be drawn given the small number of included studies and the small sample sizes of those included studies. Additional studies, including larger multicentre studies, are needed to assess the efficacy of interventions to prevent development of HUS in patients with diarrhoea due to STEC infection.\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"
},
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"role": "assistant",
"content": "We summarized the available evidence that was collected to date on methods for preventing HUS in patients diagnosed with STEC-associated diarrhoea (loose bowel movements). We searched the literature for past studies looking at different treatments aimed at preventing HUS in children with diarrhoeal illness and summarized the findings in our review,"
}
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query-laysum | 4573 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking is a leading cause of disease and death worldwide. In people who smoke, quitting smoking can reverse much of the damage. Many people use behavioural interventions to help them quit smoking; these interventions can vary substantially in their content and effectiveness.\nObjectives\nTo summarise the evidence from Cochrane Reviews that assessed the effect of behavioural interventions designed to support smoking cessation attempts and to conduct a network meta-analysis to determine how modes of delivery; person delivering the intervention; and the nature, focus, and intensity of behavioural interventions for smoking cessation influence the likelihood of achieving abstinence six months after attempting to stop smoking; and whether the effects of behavioural interventions depend upon other characteristics, including population, setting, and the provision of pharmacotherapy.\nTo summarise the availability and principal findings of economic evaluations of behavioural interventions for smoking cessation, in terms of comparative costs and cost-effectiveness, in the form of a brief economic commentary.\nMethods\nThis work comprises two main elements. 1. We conducted a Cochrane Overview of reviews following standard Cochrane methods. We identified Cochrane Reviews of behavioural interventions (including all non-pharmacological interventions, e.g. counselling, exercise, hypnotherapy, self-help materials) for smoking cessation by searching the Cochrane Library in July 2020. We evaluated the methodological quality of reviews using AMSTAR 2 and synthesised data from the reviews narratively. 2. We used the included reviews to identify randomised controlled trials of behavioural interventions for smoking cessation compared with other behavioural interventions or no intervention for smoking cessation. To be included, studies had to include adult smokers and measure smoking abstinence at six months or longer. Screening, data extraction, and risk of bias assessment followed standard Cochrane methods. We synthesised data using Bayesian component network meta-analysis (CNMA), examining the effects of 38 different components compared to minimal intervention. Components included behavioural and motivational elements, intervention providers, delivery modes, nature, focus, and intensity of the behavioural intervention. We used component network meta-regression (CNMR) to evaluate the influence of population characteristics, provision of pharmacotherapy, and intervention intensity on the component effects. We evaluated certainty of the evidence using GRADE domains. We assumed an additive effect for individual components.\nMain results\nWe included 33 Cochrane Reviews, from which 312 randomised controlled trials, representing 250,563 participants and 845 distinct study arms, met the criteria for inclusion in our component network meta-analysis. This represented 437 different combinations of components. Of the 33 reviews, confidence in review findings was high in four reviews and moderate in nine reviews, as measured by the AMSTAR 2 critical appraisal tool. The remaining 20 reviews were low or critically low due to one or more critical weaknesses, most commonly inadequate investigation or discussion (or both) of the impact of publication bias. Of note, the critical weaknesses identified did not affect the searching, screening, or data extraction elements of the review process, which have direct bearing on our CNMA. Of the included studies, 125/312 were at low risk of bias overall, 50 were at high risk of bias, and the remainder were at unclear risk. Analyses from the contributing reviews and from our CNMA showed behavioural interventions for smoking cessation can increase quit rates, but effectiveness varies on characteristics of the support provided. There was high-certainty evidence of benefit for the provision of counselling (odds ratio (OR) 1.44, 95% credibility interval (CrI) 1.22 to 1.70, 194 studies, n = 72,273) and guaranteed financial incentives (OR 1.46, 95% CrI 1.15 to 1.85, 19 studies, n = 8877). Evidence of benefit remained when removing studies at high risk of bias. These findings were consistent with pair-wise meta-analyses from contributing reviews. There was moderate-certainty evidence of benefit for interventions delivered via text message (downgraded due to unexplained statistical heterogeneity in pair-wise comparison), and for the following components where point estimates suggested benefit but CrIs incorporated no clinically significant difference: individual tailoring; intervention content including motivational components; intervention content focused on how to quit. The remaining intervention components had low-to very low-certainty evidence, with the main issues being imprecision and risk of bias. There was no evidence to suggest an increase in harms in groups receiving behavioural support for smoking cessation. Intervention effects were not changed by adjusting for population characteristics, but data were limited. Increasing intensity of behavioural support, as measured through the number of contacts, duration of each contact, and programme length, had point estimates associated with modestly increased chances of quitting, but CrIs included no difference. The effect of behavioural support for smoking cessation appeared slightly less pronounced when people were already receiving smoking cessation pharmacotherapies.\nAuthors' conclusions\nBehavioural support for smoking cessation can increase quit rates at six months or longer, with no evidence that support increases harms. This is the case whether or not smoking cessation pharmacotherapy is also provided, but the effect is slightly more pronounced in the absence of pharmacotherapy. Evidence of benefit is strongest for the provision of any form of counselling, and guaranteed financial incentives. Evidence suggested possible benefit but the need of further studies to evaluate: individual tailoring; delivery via text message, email, and audio recording; delivery by lay health advisor; and intervention content with motivational components and a focus on how to quit. We identified 23 economic evaluations; evidence did not consistently suggest one type of behavioural intervention for smoking cessation was more cost-effective than another. Future reviews should fully consider publication bias. Tools to investigate publication bias and to evaluate certainty in CNMA are needed.\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 Cochrane Reviews of behavioural support to stop smoking, to identify relevant studies of adults who smoked. We then compared the studies with each other, to find out how well the different types of behavioural support helped people to stop smoking."
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query-laysum | 4574 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile-onset Pompe disease is a rare and progressive autosomal-recessive disorder caused by a deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA). Current treatment involves enzyme replacement therapy (with recombinant human alglucosidase alfa) and symptomatic therapies (e.g. to control secretions). Children who are cross-reactive immunological material (CRIM)-negative require immunomodulation prior to commencing enzyme replacement therapy.\nEnzyme replacement therapy was developed as the most promising therapeutic approach for Pompe disease; however, the evidence is lacking, especially regarding the optimal dose and dose frequency.\nObjectives\nTo assess the effectiveness, safety and appropriate dose regimen of enzyme replacement therapy for treating infantile-onset Pompe disease.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register, which is compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Central Register of Controlled Trials (CENTRAL), Embase (Ovid), PubMed and LILACS, and CBM, CNKI, VIP, and WANFANG for literature published in Chinese. In addition, we searched three online registers: WHO International Clinical Trials Registry Platform ClinicalTrials.gov, and www.genzymeclinicalresearch.com. We also searched the reference lists of relevant articles and reviews.\nDate of last search of the Group's Inborn Errors of Metabolism Trials Register: 24 November 2016.\nSelection criteria\nRandomized and quasi-randomized controlled trials of enzyme replacement therapy in children with infantile-onset Pompe disease.\nData collection and analysis\nTwo authors independently selected relevant trials, assessed the risk of bias and extracted data. We contacted investigators to obtain important missing information.\nMain results\nWe found no trials comparing the effectiveness and safety of enzyme replacement therapy to another intervention, no intervention or placebo.\nWe found one trial (18 participants) that fulfilled the selection criteria, comparing different doses of alglucosidase alfa. The trial provided low-quality evidence (this was a small trial, there were no numerical results available by dose group, random sequence generation and allocation concealment were unclear, and there was a lack of blinding). The duration of alglucosidase alfa treatment ranged from 52 weeks (the length of the original study) to up to three years (including the extended phase of the trial), with a median duration of treatment being 2.3 years.\nThe trial only reported that clinical responses including cardiac function and motor development, as well as the proportion of children that were free of invasive ventilation, were similar in the 20 mg/kg every two weeks and the 40 mg/kg every two weeks groups (low-quality evidence). Long-term alglucosidase alfa treatment markedly extended survival as well as ventilation-free survival and improved cardiomyopathy (low-quality evidence). In relation to the number of children experiencing one or more infusion-related events, there was no significant difference between dose groups, risk ratio 0.83 (95% confidence interval 0.40 to 1.76) (low-quality of evidence). However, of note, at 52 weeks, five children in the 20 mg/kg every two weeks dose group experienced a total of 41 mild or moderate (none severe) infusion-related events and the six children in the 40 mg/kg every two weeks dose group experienced a total of 123 infusion-related events. By the end of the extended phase of the trial, five children in the 20 mg/kg every two weeks dose group experienced a total of 47 infusion-related events and the six children in the 40 mg/kg every two weeks dose group experienced a total of 177 infusion-related events. The trial was supported by the Genzyme Corporation.\nAuthors' conclusions\nThe search found no trials comparing the effectiveness and safety of enzyme replacement therapy to another intervention, no intervention or placebo. One small randomized controlled trial provided no robust evidence for which dosing schedule of alglucosidase alfa was more effective to treat infantile-onset Pompe disease. It is not deemed ethical to proceed with new placebo-controlled trials, therefore a randomized controlled trial with a large sample size comparing different dosing schedules of enzyme replacement therapy is needed. The main clinical outcomes (i.e. cardiac function, invasive ventilation, survival, motor development, adverse events (e.g. the development of antibodies)) should be standardized when evaluated and reported.\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": "There were very limited numerical results available by dose group, the trial showed no evidence in favour of a high dose as opposed to a low dose. It described that the clinical responses including cardiac function, motor development (development of a child's muscles and their ability to move around and manipulate their environment), as well as the proportion of children that were free of invasive ventilation,were similar in the two groups (low-quality evidence). Long-term alglucosidase alfa treatment markedly extended survival as well as ventilation-free survival (time without requiring a machine to help with breathing) and improved cardiomyopathy (heart disease) (low-quality evidence). In relation to the number of children experiencing one or more infusion-related events, there was no significant difference between the different dose groups (low-quality evidence), although, of note, at 52 weeks, five children in the low-dose group experienced a total of 41 mild or moderate (none were severe) infusion-related events and the six children in the high dose-group experienced a total of 123 infusion-related events. By the end of the extension phase, five children in the low-dose group experienced a total of 47 infusion-related events and the six children in the high-dose group experienced a total of 177 infusion-related events.\nNew trials should be undertaken with adequate number of participants to detect effectiveness and safety at different doses of alglucosidase alfa. The main clinical outcomes (i.e. cardiac function, time to ventilation, survival, motor development and side effects) should be standardized when evaluated and reported."
}
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query-laysum | 4575 | [
{
"role": "user",
"content": "Abstract: Background\nRecruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research.\nObjectives\nTo quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment.\nSearch methods\nWe searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015).\nSelection criteria\nRandomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants.\nData collection and analysis\nWe extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison.\nMain results\nWe identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.\nWe found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.\n1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).\n2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).\n3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI −1% to 3%).\nWe had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.\nWe had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones.\nAuthors' conclusions\nThe literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones.\n\nGiven the provided abstract, please respond to the following query: \"The small print\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Our search updated our 2010 review and is current to February 2015. We also identified six studies published after 2015 outside the search. The review includes 24 mock trials where the researchers asked people about whether they would take part in an imaginary trial. We have not presented or discussed their results because it is hard to see how the findings relate to real trial decisions."
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query-laysum | 4576 | [
{
"role": "user",
"content": "Abstract: Background\nCrowded teeth develop when there is not enough space in the jaws into which the teeth can erupt. Crowding can affect baby teeth (deciduous dentititon), adult teeth (permanent dentition), or both, and is a common reason for referral to an orthodontist. Crowded teeth can affect a child's self-esteem and quality of life. Early loss of baby teeth as a result of tooth decay or trauma, can lead to crowded permanent teeth. Crowding tends to increase with age, especially in the lower jaw.\nObjectives\nTo assess the effects of orthodontic intervention for preventing or correcting crowded teeth in children.\nTo test the null hypothesis that there are no differences in outcomes between different orthodontic interventions for preventing or correcting crowded teeth in children.\nSearch methods\nCochrane Oral Health's Information Specialist searched four bibliographic databases up to 11 January 2021 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated any active interventions to prevent or correct dental crowding in children and adolescents, such as orthodontic braces or extractions, compared to no or delayed treatment, placebo treatment or another active intervention. The studies had to include at least 80% of participants aged 16 years and under.\nData collection and analysis\nTwo review authors, independently and in duplicate, extracted information regarding methods, participants, interventions, outcomes, harms and results. We resolved any disagreements by liaising with a third review author. We used the Cochrane risk of bias tool to assess the risk of bias in the studies. We calculated mean differences (MDs) with 95% confidence intervals (CI) for continuous data and odds ratios (ORs) with 95% CIs for dichotomous data. We undertook meta-analysis when studies of similar comparisons reported comparable outcome measures, using the random-effects model. We used the I2 statistic as a measure of statistical heterogeneity.\nMain results\nOur search identified 24 RCTs that included 1512 participants, 1314 of whom were included in analyses. We assessed 23 studies as being at high risk of bias and one as unclear.\nThe studies investigated 17 comparisons. Twenty studies evaluated fixed appliances and auxiliaries (lower lingual arch, lower lip bumper, brackets, archwires, lacebacks, headgear and adjunctive vibrational appliances); two studies evaluated removable appliances and auxiliaries (Schwarz appliance, eruption guidance appliance); and two studies evaluated dental extractions (lower deciduous canines or third molars).\nThe evidence should be interpreted cautiously as it is of very low certainty. Most interventions were evaluated by a single study.\nFixed appliances and auxiliaries\nOne study found that use of a lip bumper may reduce crowding in the early permanent dentition (MD −4.39 mm, 95% CI −5.07 to −3.71; 34 participants). One study evaluated lower lingual arch but did not measure amount of crowding.\nOne study concluded that coaxial nickel-titanium (NiTi) archwires may cause more tooth movement in the lower arch than single-stranded NiTi archwires (MD 6.77 mm, 95% CI 5.55 to 7.99; 24 participants). Another study, comparing copper NiTi versus NiTi archwires, found NiTi to be more effective for reducing crowding (MD 0.49 mm, 95% CI 0.35 to 0.63, 66 participants). Single studies did not show evidence of one type of archwire being better than another for Titinol versus Nitinol; nickel-titanium versus stainless steel or multistrand stainless steel; and multistranded stainless steel versus stainless steel.\nNor did single studies find evidence of a difference in amount of crowding between self-ligating and conventional brackets, active and passive self-ligating brackets, lacebacks added to fixed appliances versus fixed appliances alone, or cervical pull headgear versus minor interceptive procedures.\nMeta-analysis of two studies showed no evidence that adding vibrational appliances to fixed appliances reduces crowding at 8 to 10 weeks (MD 0.24 mm, 95% CI −0.81 to 1.30; 119 participants).\nRemovable appliances and auxiliaries\nOne study found use of the Schwarz appliance may be effective at treating dental crowding in the lower arch (MD -2.14 mm, 95% CI −2.79 to −1.49; 28 participants). Another study found an eruption guidance appliance may reduce the number of children with crowded teeth after one year of treatment (OR 0.19, 95% CI 0.05 to 0.68; 46 participants); however, this may have been due to an increase in lower incisor proclination in the treated group. Whether these gains were maintained in the longer term was not assessed.\nDental extractions\nOne study found that extracting children's lower deciduous canines had more effect on crowding after one year than no treatment (MD −4.76 mm, 95 CI −6.24 to −3.28; 83 participants), but this was alongside a reduction in arch length. One study found that extracting wisdom teeth did not seem to reduce crowding any more than leaving them in the mouth (MD −0.30 mm, 95% CI −1.30 to 0.70; 77 participants).\nAuthors' conclusions\nMost interventions were assessed by single, small studies. We found very low-certainty evidence that lip bumper, used in the mixed dentition, may be effective for preventing crowding in the early permanent dentition, and a Schwarz appliance may reduce crowding in the lower arch. We also found very low-certainty evidence that coaxial NiTi may be better at reducing crowding than single-stranded NiTi, and that NiTi may be better than copper NiTi. As the current evidence is of very low certainty, our findings may change with future research.\n\nGiven the provided abstract, please respond to the following query: \"Removeable braces and related items\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The Schwarz appliance may reduce crowding in the lower arch, when measured at nine months. Use of an eruption guidance appliance, for a year, may reduce likelihood of crowding, but there may be other explanations for this. Again, we cannot be sure of these findings."
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query-laysum | 4577 | [
{
"role": "user",
"content": "Abstract: Background\nDementia is a syndrome of acquired cognitive impairment which is severe enough to interfere with independent living. Over the course of the illness, people with dementia also experience changes in emotions, behaviour and social relationships. According to Alzheimer's Disease International, dementia affects approximately 55 million people worldwide. The latest NICE guideline for dementia highlights the value of diverse treatment options for the different stages and symptoms of dementia, including non-pharmacological treatments. Relevant literature also argues for the value of interventions that acknowledge the complexity of the condition and address the person as a whole, including their physical, emotional, social and cognitive processes. A growing literature highlights the capacity of the arts and has embodied practices to address this complexity. Dance movement therapy (DMT) is an embodied psychological intervention that can address complexity and thus may be useful for people with dementia, but its effectiveness remains unclear.\nObjectives\nTo assess the effects of dance movement therapy on behavioural, social, cognitive and emotional symptoms of people with dementia in comparison to no treatment, standard care or any other treatment. Also, to compare different forms of dance movement therapy (e.g. Laban-based dance movement therapy, Chacian dance movement therapy or Authentic Movement)\nSearch methods\nWe searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register of the International Clinical Trials Registry Portal until 8 December 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that included people with dementia, of any age and in any setting. The DMT intervention had to be delivered by a dance movement therapy practitioner who (i) had received formal training (ii) was a dance movement therapist in training or (iii) was otherwise recognised as a dance movement therapist in the country in which the study was conducted.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and evaluated methodological quality. We expressed effect estimates using the mean difference (MD) between intervention groups and presented associated confidence intervals (CIs). We used GRADE methods to rate our certainty in the results.\nMain results\nWe found only one study eligible for inclusion in this review. This was a 3-arm parallel-group RCT conducted in Hong Kong involving 204 adults with mild neurocognitive disorder or dementia. The study examined the effects of short-term (12 weeks) group DMT in comparison with exercise and a waiting-list control group immediately post-intervention and three and nine months later.\nWe found that, at the end of the intervention, DMT may result in little to no difference in neuropsychiatric symptoms assessed with the 12-item Neuropsychiatric Inventory when compared with waiting list (MD 0.3, 95% CI -0.96 to 1.56; low-certainty evidence) or exercise (MD -0.30, 95% CI -1.83 to 1.23; low-certainty evidence). Nor was there any evidence of effects at later time points.\nCognitive functioning was assessed with a variety of instruments and there were no statistically significant between-group differences (low-certainty evidence). When compared to exercise or waiting list, DMT may result in little to no difference in cognitive function immediately after the intervention or at follow-up.\nIn comparison to waiting list, DMT may result in a slight reduction in depression assessed with the 4-item Geriatric Depression Scale at the end of therapy (MD -0.60, 95% CI -0.96 to -0.24; low-certainty evidence). This slight positive effect of DMT on depression scores was sustained at three and nine months after the completion of the intervention. DMT may also reduce depression slightly in comparison with exercise at the end of therapy (MD -0.40, 95% CI -0.76 to -0.04, low-certainty evidence), an effect also sustained at three and nine months.\nOur fourth primary outcome, quality of life, was not assessed in the included study.\nThere were data for two of our secondary outcomes, social and occupational functioning and dropouts (which we used as a proxy for acceptability), but in both cases the evidence was of very low certainty and hence our confidence in the results was very low.\nFor all outcomes, we considered the certainty of the evidence in relation to our review objectives to be low or very low in GRADE terms due to indirectness (because not all participants in the included study had a diagnosis of dementia) and imprecision.\nAuthors' conclusions\nThis review included one RCT with a low risk of bias. Due to the low certainty of the evidence, the true effects of DMT as an intervention for dementia may be substantially different from those found. More RCTs are needed to determine with any confidence whether DMT has beneficial effects on dementia.\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 did not find any difference between dance movement therapy and either exercise or waiting list for overall behaviour and mental well-being or for cognition. For depression, we found that there may be a small beneficial effect of dance movement therapy compared with exercise or waiting list, and this effect was still present three and nine months after the end of the therapy. However, we are not sure whether or not the effect was large enough to be really noticeable to the people with dementia. The study did not measure the participants' quality of life."
}
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query-laysum | 4578 | [
{
"role": "user",
"content": "Abstract: Background\nDysmenorrhoea (painful menstrual cramps) is common and a major cause of pain in women. Combined oral contraceptives (OCPs) are often used in the management of primary dysmenorrhoea, but there is a need for reporting the benefits and harms. Primary dysmenorrhoea is defined as painful menstrual cramps without pelvic pathology.\nObjectives\nTo evaluate the benefits and harms of combined oral contraceptive pills for the management of primary dysmenorrhoea.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date 28 March 2023.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing all combined OCPs with other combined OCPs, placebo, or management with non-steroidal anti-inflammatory drugs (NSAIDs). Participants had to have primary dysmenorrhoea, diagnosed by ruling out pelvic pathology through pelvic examination or ultrasound.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary outcomes were pain score after treatment, improvement in pain, and adverse events.\nMain results\nWe included 21 RCTs (3723 women). Eleven RCTs compared combined OCP with placebo, eight compared different dosages of combined OCP, one compared two OCP regimens with placebo, and one compared OCP with NSAIDs.\nOCP versus placebo or no treatment\nOCPs reduce pain in women with dysmenorrhoea more effectively than placebo. Six studies reported treatment effects on different scales; the result can be interpreted as a moderate reduction in pain (standardised mean difference (SMD) −0.58, 95% confidence interval (CI) −0.74 to −0.41; I² = 28%; 6 RCTs, 588 women; high-quality evidence). Six studies also reported pain improvement as a dichotomous outcome (risk ratio (RR) 1.65, 95% CI 1.29 to 2.10; I² = 69%; 6 RCTs, 717 women; low-quality evidence). The data suggest that in women with a 28% chance of improvement in pain with placebo or no treatment, the improvement in women using combined OCP will be between 37% and 60%.\nCompared to placebo or no treatment, OCPs probably increase the risk of any adverse events (RR 1.31, 95% CI 1.20 to 1.43; I² = 79%; 7 RCTs, 1025 women; moderate-quality evidence), and may also increase the risk of serious adverse events (RR 1.77, 95% CI 0.49 to 6.43; I² = 22%; 4 RCTs, 512 women; low-quality evidence).\nWomen who received OCPs had an increased risk of irregular bleeding compared to women who received placebo or no treatment (RR 2.63, 95% CI 2.11 to 3.28; I² = 29%; 7 RCTs, 1025 women; high-quality evidence). In women with a risk of irregular bleeding of 18% if using placebo or no treatment, the risk would be between 39% and 60% if using combined OCP. OCPs probably increase the risk of headaches (RR 1.51, 95% CI 1.11 to 2.04; I² = 44%; 5 RCTs, 656 women; moderate-quality evidence), and nausea (RR 1.64, 95% CI 1.17 to 2.30; I² = 39%; 8 RCTs, 948 women; moderate-quality evidence). We are uncertain of the effect of OCP on weight gain (RR 1.83, 95% CI 0.75 to 4.45; 1 RCT, 76 women; low-quality evidence). OCPs may slightly reduce requirements for additional medication (RR 0.63, 95% CI 0.40 to 0.98; I² = 0%; 2 RCTs, 163 women; low-quality evidence), and absence from work (RR 0.63, 95% CI 0.41 to 0.97; I² = 0%; 2 RCTs, 148 women; low-quality evidence).\nOne OCP versus another OCP\nContinuous use of OCPs (no pause or inactive tablets after the usual 21 days of hormone pills) may reduce pain in women with dysmenorrhoea more effectively than the standard regimen (SMD −0.73, 95% CI −1.13 to 0.34; 2 RCTs, 106 women; low-quality evidence). There was insufficient evidence to determine if there was a difference in pain improvement between ethinylestradiol 20 μg and ethinylestradiol 30 μg OCPs (RR 1.06, 95% CI 0.65 to 1.74; 1 RCT, 326 women; moderate-quality evidence). There is probably little or no difference between third- and fourth-generation and first- and second-generation OCPs (RR 0.99, 95% CI 0.93 to 1.05; 1 RCT, 178 women; moderate-quality evidence). The standard regimen of OCPs may slightly increase the risk of any adverse events over the continuous regimen (RR 1.11, 95% CI 1.01 to 1.22; I² = 76%; 3 RCTs, 602 women; low-quality evidence), and probably increases the risk of irregular bleeding (RR 1.38, 95% CI 1.14 to 1.69; 2 RCTs, 379 women; moderate-quality evidence). Due to lack of studies, it is uncertain if there is a difference between continuous and standard regimen OCPs in serious adverse events (RR 0.34, 95% CI 0.01 to 8.24; 1 RCT, 212 women), headaches (RR 0.94, 95% CI 0.50 to 1.76; I² = 0%; 2 RCTs, 435 women), or nausea (RR 1.08, 95% CI 0.51 to 2.30; I² = 23%; 2 RCTs, 435 women) (all very low-quality evidence).\nWe are uncertain if one type of OCP reduces absence from work more than the other (RR 1.12, 95% CI 0.64 to 1.99; 1 RCT, 445 women; very low-quality evidence).\nOCPs versus NSAIDs\nThere were insufficient data to determine whether OCPs were more effective than NSAIDs for pain (mean difference −0.30, 95% CI −5.43 to 4.83; 1 RCT, 91 women; low-quality evidence). The study did not report on adverse events.\nAuthors' conclusions\nOCPs are effective for treating dysmenorrhoea, but they cause irregular bleeding, and probably headache and nausea. Long-term effects were not covered in this review. Continuous use of OCPs was probably more effective than the standard regimen but safety should be ensured with long-term data. Due to lack of data, we are uncertain whether NSAIDs are better than OCPs for treating dysmenorrhoea.\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": "OCPs are readily used as a treatment for menstrual cramps, but the evidence was uncertain about the effects."
}
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query-laysum | 4579 | [
{
"role": "user",
"content": "Abstract: Background\nWorldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite high perfect-use effectiveness rates, typical-use effectiveness rates for shorter-term methods such as oral and injectable contraceptives are much lower. In large part, this disparity reflects difficulties in ongoing adherence to the contraceptive regimen and low continuation rates. Correct use of contraceptives to ensure effectiveness is vital to reducing unintended pregnancy.\nObjectives\nTo determine the effectiveness of strategies aiming to improve adherence to, and continuation of, shorter-term hormonal methods of contraception compared with usual family planning care.\nSearch methods\nWe searched to July 2018 in the following databases (without language restrictions): The Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), PubMed via MEDLINE, POPLINE, Web of Science, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing strategies aimed to facilitate adherence and continuation of shorter-term hormonal methods of contraception (such as oral contraceptives (OCs), injectable depot medroxyprogesterone acetate (DMPA or Depo-Provera), intravaginal ring, or transdermal patch) with usual family planning care in reproductive age women seeking to avoid pregnancy.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary outcomes were continuation or discontinuation of contraceptive method, rates of discontinuation due to adverse events (menstrual disturbances and all other adverse events), and adherence to method use as indicated by missed pills and on-time/late injections. Pregnancy was a secondary outcome.\nMain results\nWe included 10 RCTs involving 6242 women. Six trials provided direct in-person counseling using either multiple counseling contacts or multiple components during one visit. Four trials provided intensive reminders of appointments or next dosing, of which two provided additional educational health information as well as reminders. All trials stated 'usual care' as the comparison.\nThe certainty of the evidence ranged from very low to moderate. Main limitations were risk of bias (associated with poor reporting of methodological detail, lack of blinding, and incomplete outcome data), inconsistency, indirectness, and imprecision.\nContinuation of hormonal contraceptive methods\nIt is uncertain whether intensive counseling improves continuation of hormonal contraceptive methods compared with usual care (OR 1.28, 95% CI 1.07 to 1.54; 2624 participants; 6 studies; I2 = 79%; very low certainty evidence). The evidence suggested: if the chance of continuation with usual care is 39%, the chance of continuation with intensive counseling would be between 41% and 50%. The overall pooled OR suggested continuation of improvement, however, when stratified by contraceptive method type, the positive results were restricted to DMPA.\nIt is uncertain whether reminders (+/- educational information) improve continuation of hormonal contraceptive methods compared with usual care (OR 1.33, 95% CI 1.03 to 1.73; 933 participants; 2 studies; I2 = 69%; very low certainty evidence).The evidence suggested: if the chance of continuation with usual care is 52%, the chance of continuation with reminders would be between 52% and 65%.\nDiscontinuation due to adverse events\nThe evidence suggested that counseling may be associated with a decreased rate of discontinuation due to adverse events compared with usual care, with a lower rate of discontinuation due to menstrual disturbances (OR 0.20, 95% CI 0.11 to 0.37; 350 participants; 1 study; low certainty evidence), but may make little or no difference to all other adverse events (OR 0.73, 95% CI 0.36 to 1.47; 350 participants; 1 study; low certainty evidence). The evidence suggested: if the chance of discontinuation with usual care due to menstrual disturbances is 32%, the chance of discontinuation with intensive counseling would be between 5% and 15%; and that if the chance of discontinuation with usual care due to other adverse events is 55%, the chance of discontinuation with intensive counseling would be between 30% and 64%.\nDiscontinuation was not reported among trials that investigated the use of reminders (+/- educational information).\nAdherence\nAdherence was not reported among trials that investigated the use of intensive counseling.\nAmong trials that investigated reminders (+/- educational information), there was no conclusive evidence of a difference in adherence as indicated by missed pills (MD 0.80, 95% CI -1.22 to 2.82; 73 participants; 1 study; moderate certainty evidence) or by on-time injections (OR 0.84, 95% CI 0.54 to 1.29; 350 participants; 2 studies; I2 = 0%; low certainty evidence). The evidence suggested: if the chance of adherence to method use as indicated by on-time injections with usual care is 50%, the chance of adherence with method use as indicated by on-time injections with reminders would be between 35% and 56%.\nPregnancy\nThere was no conclusive evidence of a difference in rates of pregnancy between intensive counseling and usual care (OR 1.24, 95% CI 0.98 to 1.57; 1985 participants; 3 studies; I2 = 0%, very low certainty evidence). The evidence suggested: if the chance of pregnancy with usual care is 18%, the chance of pregnancy with counseling would be between 18% and 25%.\nPregnancy was not reported among trials that investigated the use of reminders (+/- educational information).\nAuthors' conclusions\nDespite the importance of this topic, studies have not been published since the last review in 2013 (nine studies) with only one study added in 2019 that neither changed the results nor improved the certainty of evidence.\nOverall, the certainty of evidence for strategies to improve adherence and continuation of contraceptives is low. Intensive counseling and reminders (with or without educational information) may be associated with improved continuation of shorter-term hormonal contraceptive methods when compared with usual family planning care. However, this should be interpreted with caution due to the low certainty of the evidence. Included trials used a variety of shorter-term hormonal contraceptive methods which may account for the high heterogeneity. It is possible that the effectiveness of strategies for improving adherence and continuation are contingent on the contraceptive method targeted. There was limited reporting of objectively measurable outcomes (e.g. electronic monitoring device) among included studies. Future trials would benefit from standardized definitions and measurements of adherence, and consistent terminology for describing interventions and comparisons. Further research requires larger studies, follow-up of at least one year, and improved reporting of trial methodology.\n\nGiven the provided abstract, please respond to the following query: \"What is the question?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What is the effectiveness of methods focused on improving proper and continued use of shorter-term hormonal methods of contraception (such as counseling techniques, or educational, motivational, or reminder messages) compared with usual family planning care (such as routine counseling or no reminder messages)."
}
]
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query-laysum | 4580 | [
{
"role": "user",
"content": "Abstract: Background\nHistorically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine.\nObjectives\nThe primary objective was to assess the effects, on women and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:\n1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.\n2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;\n3. Timing of onset (early or later in labour);\n4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);\n5. Country income level (high-income compared to low- and middle-income).\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies.\nSelection criteria\nAll published and unpublished randomised controlled trials, cluster-randomised trials comparing continuous support during labour with usual care. Quasi-randomised and cross-over designs were not eligible for inclusion.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought additional information from the trial authors. The quality of the evidence was assessed using the GRADE approach.\nMain results\nWe included a total of 27 trials, and 26 trials involving 15,858 women provided usable outcome data for analysis. These trials were conducted in 17 different countries: 13 trials were conducted in high-income settings; 13 trials in middle-income settings; and no studies in low-income settings. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (average RR 1.08, 95% confidence interval (CI) 1.04 to 1.12; 21 trials, 14,369 women; low-quality evidence) and less likely to report negative ratings of or feelings about their childbirth experience (average RR 0.69, 95% CI 0.59 to 0.79; 11 trials, 11,133 women; low-quality evidence) and to use any intrapartum analgesia (average RR 0.90, 95% CI 0.84 to 0.96; 15 trials, 12,433 women). In addition, their labours were shorter (MD -0.69 hours, 95% CI -1.04 to -0.34; 13 trials, 5429 women; low-quality evidence), they were less likely to have a caesarean birth (average RR 0.75, 95% CI 0.64 to 0.88; 24 trials, 15,347 women; low-quality evidence) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96; 19 trials, 14,118 women), regional analgesia (average RR 0.93, 95% CI 0.88 to 0.99; 9 trials, 11,444 women), or a baby with a low five-minute Apgar score (RR 0.62, 95% CI 0.46 to 0.85; 14 trials, 12,615 women). Data from two trials for postpartum depression were not combined due to differences in women, hospitals and care providers included; both trials found fewer women developed depressive symptomatology if they had been supported in birth, although this may have been a chance result in one of the studies (low-quality evidence). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, such as admission to special care nursery (average RR 0.97, 95% CI 0.76 to 1.25; 7 trials, 8897 women; low-quality evidence), and exclusive or any breastfeeding at any time point (average RR 1.05, 95% CI 0.96 to 1.16; 4 trials, 5584 women; low-quality evidence).\nSubgroup analyses suggested that continuous support was most effective at reducing caesarean birth, when the provider was present in a doula role, and in settings in which epidural analgesia was not routinely available. Continuous labour support in settings where women were not permitted to have companions of their choosing with them in labour, was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. Subgroup analysis of trials conducted in high-income compared with trials in middle-income countries suggests that continuous labour support offers similar benefits to women and babies for most outcomes, with the exception of caesarean birth, where studies from middle-income countries showed a larger reduction in caesarean birth. No conclusions could be drawn about low-income settings, electronic fetal monitoring, the timing of onset of continuous support or model of support.\nRisk of bias varied in included studies: no study clearly blinded women and personnel; only one study sufficiently blinded outcome assessors. All other domains were of varying degrees of risk of bias. The quality of evidence was downgraded for lack of blinding in studies and other limitations in study designs, inconsistency, or imprecision of effect estimates.\nAuthors' conclusions\nContinuous support during labour may improve outcomes for women and infants, including increased spontaneous vaginal birth, shorter duration of labour, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional analgesia, low five-minute Apgar score and negative feelings about childbirth experiences. We found no evidence of harms of continuous labour support. Subgroup analyses should be interpreted with caution, and considered as exploratory and hypothesis-generating, but evidence suggests continuous support with certain provider characteristics, in settings where epidural analgesia was not routinely available, in settings where women were not permitted to have companions of their choosing in labour, and in middle-income country settings, may have a favourable impact on outcomes such as caesarean birth. Future research on continuous support during labour could focus on longer-term outcomes (breastfeeding, mother-infant interactions, postpartum depression, self-esteem, difficulty mothering) and include more woman-centred outcomes in low-income settings.\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": "In the past, women have been cared for and supported by other women during labour and birth, and have had someone with them throughout, which we call ‘continuous support’. However, in many countries more women are giving birth in hospital rather than at home. This has meant continuous support during labour has become the exception rather than the norm. The aim of this Cochrane Review was to understand the effect of continuous support on a woman during labour and childbirth, and on her baby. We collected and analysed all relevant studies to answer this question (search date: October 2016)."
}
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query-laysum | 4581 | [
{
"role": "user",
"content": "Abstract: Background\nEmbryo transfer (ET) was traditionally performed two days after oocyte retrieval; however, developments in culture media have allowed embryos to be maintained in culture for longer periods. Delaying transfer from Day two to Day three would allow for further development of the embryo and might have a positive effect on pregnancy outcomes.\nObjectives\nTo determine if there are any differences in live birth and pregnancy rates when embryo transfer is performed on day three after oocyte retrieval, compared with day two, in infertile couples undergoing treatment with in vitro fertilisation (IVF), including intracytoplasmic sperm injection (ICSI).\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid) from the inception of the databases to 26th April 2016. We also searched ClinicalTrials.gov and the WHO portal for ongoing trials plus citation lists of relevant publications, review articles and included studies, as well as abstracts of appropriate scientific meetings.\nSelection criteria\nRandomised controlled trials that compared Day 3 versus Day 2 embryo transfer after oocyte retrieval during an IVF or ICSI treatment cycle in infertile couples.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. The primary outcome measures were live birth rate and ongoing pregnancy rate.\nMain results\nWe included 15 studies. Fourteen studies reported data per woman (2894 women) and one study reported data per cycle (969 cycles). The quality of the evidence using the GRADE approach ranged from moderate quality to very low quality. The main reasons for downgrading evidence were poor methodological reporting, selective reporting, inconsistency and imprecision.\nLive birth per woman - Overall, there was no evidence of a difference in live birth rate between Day three and Day two embryo transfer (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.89 to 1.23; three studies, n = 1200 women; I2 = 63%; very low quality evidence). The data suggest that if 32% of women who underwent a Day two embryo transfer had a live birth, then between 28% to 39% of women undergoing a Day three embryo transfer would have a live birth.\nOngoing pregnancy per woman - There was no evidence of a difference between Day three and Day two embryo transfer for ongoing pregnancy (RR 0.98, 95% CI 0.85 to 1.12; six studies, n = 1740 women; I2 = 52%; very low quality of evidence). The data suggest that if 33% of women undergoing a Day two embryo transfer had an ongoing pregnancy then between 28% to 37% of women undergoing a Day three embryo transfer would have an ongoing pregnancy.\nClinical pregnancy per woman - There was no evidence of a difference between Day three and Day two embryo transfer for the chance of a clinical pregnancy (RR 1.08, 95% CI 0.98 to 1.19; 12 studies, n = 2461, I2 = 51%; very low quality evidence). The data suggest that if 39% of women undergoing Day two embryo transfer had a clinical pregnancy, then between 38% to 46% of women undergoing a Day three embryo transfer would have a clinical pregnancy.\nMultiple pregnancy per woman - There was no evidence of a difference between Day three and Day two embryo transfer for the risk of a multiple pregnancy (RR 1.12, 95% CI 0.86 to 1.44; eight studies, n = 1837; I2 = 0%; moderate quality evidence). The data suggest that if 11% of women undergoing Day two embryo transfer had a multiple pregnancy, then between 9% to 15% of women undergoing a Day three embryo transfer would have a multiple pregnancy.\nMiscarriage rate per woman - There was no evidence of a difference between Day three and Day two embryo transfer for the risk of miscarriage (RR 1.16, 95% CI 0.84 to 1.60; nine studies, n = 2153 women, I2 = 26%; moderate quality evidence). The data suggest that if 6% of women undergoing Day two embryo transfer had a miscarriage, then between 5% to 10% of women undergoing a Day three embryo transfer would have a miscarriage.\nEctopic pregnancy rate per woman - There was no evidence of a difference between Day three and Day two embryo transfer for the risk of ectopic pregnancy (RR 0.99, 95% CI 0.29 to 3.40; six studies, n = 1531 women, I2 = 0%; low quality evidence). The data suggest that if 0.7% of women undergoing Day two embryo transfer have an ectopic pregnancy, then between 0.2% to 2% of women undergoing Day three embryo transfer would have an ectopic pregnancy.\nSubgroup analysis for pregnancy outcomes did not identify any differential effect between IVF and ICSI.\nNone of the included studies prespecified complication rate (e.g. OHSS), fetal abnormality or women's evaluation of the procedure as outcomes in their studies.\nAuthors' conclusions\nTwelve of 15 studies contributed data that could be included in meta-analyses. The quality of the evidence ranged from moderate to very low. Only three of the 15 studies reported data for live birth, although the data for ongoing pregnancy and clinical pregnancy are consistent with the live birth data, suggesting no difference between Day three and Day two embryo transfer for these outcomes. There was no evidence of a difference identified between Day three and Day two embryo transfer for multiple pregnancy, miscarriage or ectopic pregnancy per woman randomised. No data were reported for complication rate, fetal abnormality or woman's evaluation of the procedure. The current evidence has not identified any evidence of differences in pregnancy outcomes between Day two and Day three embryo transfers. Any further studies comparing these timings of embryo transfer are unlikely to alter the findings and we suggest that this review no longer be updated.\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": "Only three of 15 studies reported on live birth as an outcome. We found that there was no clear evidence of a difference between Day three and Day two embryo transfer for rates of live birth, ongoing pregnancy, clinical pregnancy, multiple pregnancy or miscarriage. There were no data reported for complication rate, fetal abnormality or women's evaluation of the procedure."
}
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query-laysum | 4582 | [
{
"role": "user",
"content": "Abstract: Background\nIntrauterine insemination (IUI), combined with ovarian stimulation (OS), has been demonstrated to be an effective treatment for infertile couples. Several agents for ovarian stimulation, combined with IUI, have been proposed, but it is still not clear which agents for stimulation are the most effective. This is an update of the review, first published in 2007.\nObjectives\nTo assess the effects of agents for ovarian stimulation for intrauterine insemination in infertile ovulatory women.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trial registers from their inception to November 2020. We performed reference checking and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included truly randomised controlled trials (RCTs) that compared different agents for ovarian stimulation combined with IUI for infertile ovulatory women concerning couples with unexplained infertility. mild male factor infertility and minimal to mild endometriosis.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane.\nMain results\nIn this updated review, we have included a total of 82 studies, involving 12,614 women. Due to the multitude of comparisons between different agents for ovarian stimulation, we highlight the seven most often reported here.\nGonadotropins versus anti-oestrogens (13 studies)\nFor live birth, the results of five studies were pooled and showed a probable improvement in the cumulative live birth rate for gonadotropins compared to anti-oestrogens (odds ratio (OR) 1.37, 95% confidence interval (CI) 1.05 to 1.79; I2 = 30%; 5 studies, 1924 participants; moderate-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is assumed to be 22.8%, the chance following gonadotropins would be between 23.7% and 34.6%. The pooled effect of seven studies revealed that we are uncertain whether gonadotropins lead to a higher multiple pregnancy rate compared with anti-oestrogens (OR 1.58, 95% CI 0.60 to 4.17; I2 = 58%; 7 studies, 2139 participants; low-certainty evidence).\nAromatase inhibitors versus anti-oestrogens (8 studies)\nOne study reported live birth rates for this comparison. We are uncertain whether aromatase inhibitors improve live birth rate compared with anti-oestrogens (OR 0.75, CI 95% 0.51 to 1.11; 1 study, 599 participants; low-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is 23.4%, the chance following aromatase inhibitors would be between 13.5% and 25.3%. The results of pooling four studies revealed that we are uncertain whether aromatase inhibitors compared with anti-oestrogens lead to a higher multiple pregnancy rate (OR 1.28, CI 95% 0.61 to 2.68; I2 = 0%; 4 studies, 1000 participants; low-certainty evidence).\nGonadotropins with GnRH (gonadotropin-releasing hormone) agonist versus gonadotropins alone (4 studies)\nNo data were available for live birth. The pooled effect of two studies revealed that we are uncertain whether gonadotropins with GnRH agonist lead to a higher multiple pregnancy rate compared to gonadotropins alone (OR 2.53, 95% CI 0.82 to 7.86; I2 = 0; 2 studies, 264 participants; very low-certainty evidence).\nGonadotropins with GnRH antagonist versus gonadotropins alone (14 studies)\nThree studies reported live birth rate per couple, and we are uncertain whether gonadotropins with GnRH antagonist improve live birth rate compared to gonadotropins (OR 1.5, 95% CI 0.52 to 4.39; I2 = 81%; 3 studies, 419 participants; very low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 25.7%, the chance following gonadotropins combined with GnRH antagonist would be between 15.2% and 60.3%. We are also uncertain whether gonadotropins combined with GnRH antagonist lead to a higher multiple pregnancy rate compared with gonadotropins alone (OR 1.30, 95% CI 0.74 to 2.28; I2 = 0%; 10 studies, 2095 participants; moderate-certainty evidence).\nGonadotropins with anti-oestrogens versus gonadotropins alone (2 studies)\nNeither of the studies reported data for live birth rate. We are uncertain whether gonadotropins combined with anti-oestrogens lead to a higher multiple pregnancy rate compared with gonadotropins alone, based on one study (OR 3.03, 95% CI 0.12 to 75.1; 1 study, 230 participants; low-certainty evidence).\nAromatase inhibitors versus gonadotropins (6 studies)\nTwo studies revealed that aromatase inhibitors may decrease live birth rate compared with gonadotropins (OR 0.49, 95% CI 0.34 to 0.71; I2=0%; 2 studies, 651 participants; low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 31.9%, the chance of live birth following aromatase inhibitors would be between 13.7% and 25%. We are uncertain whether aromatase inhibitors compared with gonadotropins lead to a higher multiple pregnancy rate (OR 0.69, 95% CI 0.06 to 8.17; I2=77%; 3 studies, 731 participants; very low-certainty evidence).\nAromatase inhibitors with gonadotropins versus anti-oestrogens with gonadotropins (8 studies)\nWe are uncertain whether aromatase inhibitors combined with gonadotropins improve live birth rate compared with anti-oestrogens plus gonadotropins (OR 0.99, 95% CI 0.3 8 to 2.54; I2 = 69%; 3 studies, 708 participants; very low-certainty evidence). This suggests that if the chance of a live birth following anti-oestrogens plus gonadotropins is 13.8%, the chance following aromatase inhibitors plus gonadotropins would be between 5.7% and 28.9%. We are uncertain of the effect of aromatase inhibitors combined with gonadotropins compared to anti-oestrogens combined with gonadotropins on multiple pregnancy rate (OR 1.31, 95% CI 0.39 to 4.37; I2 = 0%; 5 studies, 901 participants; low-certainty evidence).\nAuthors' conclusions\nBased on the available results, gonadotropins probably improve cumulative live birth rate compared with anti-oestrogens (moderate-certainty evidence). Gonadotropins may also improve cumulative live birth rate when compared with aromatase inhibitors (low-certainty evidence). From the available data, there is no convincing evidence that aromatase inhibitors lead to higher live birth rates compared to anti-oestrogens. None of the agents compared lead to significantly higher multiple pregnancy rates. Based on low-certainty evidence, there does not seem to be a role for different combined therapies, nor for adding GnRH agonists or GnRH antagonists in IUI programs.\n\nGiven the provided abstract, please respond to the following query: \"Gonadotropins plus GnRH antagonists versus gonadotropins alone (14 studies)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We don’t know if gonadotropins plus GnRH antagonists make any difference to:\n· live birth rate; or\n· multiple pregnancy rate."
}
]
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query-laysum | 4583 | [
{
"role": "user",
"content": "Abstract: Background\nEndotracheal suctioning consists of the mechanical aspiration of pulmonary secretions from the endotracheal tube (ETT) to prevent obstruction. The optimal frequency of ETT suctioning has not been defined.\nObjectives\nTo determine the effect of specific ordered frequency of ETT suctioning ('as scheduled') versus ETT suctioning only in case of indications ('as needed') and of more frequent ETT suctioning versus less frequent ETT suctioning on respiratory morbidity in ventilated newborns.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 10), MEDLINE via PubMed (1966 to 31 October 2015), EMBASE (1980 to 31 October 2015), and CINAHL (1982 to 31 October 2015). We checked the reference lists of retrieved articles and contacted study authors to identify additional studies. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nRandomized, quasi-randomized, and cluster randomized controlled trials comparing different strategies regarding the frequency of ETT suctioning of newborn infants receiving ventilator support.\nData collection and analysis\nWe used the standard methods of the Cochrane Neonatal Review Group. Two review authors independently extracted data and assessed the risk of bias of trials. The primary outcome was bronchopulmonary dysplasia or chronic lung disease.\nMain results\nWe identified one randomized controlled study recruiting 97 low birthweight infants that met the inclusion criteria. The study was conducted in the UK in 1987 and 1988. Randomized infants received ETT suctioning every six or 12 hours during the first three days of life. The quality of reporting was limited and we rated the trial at high risk of bias. Furthermore, the trial lacked adequate power. There were no statistically significant differences in any of reported outcomes: bronchopulmonary dysplasia (defined as oxygen at more than 30 days; risk ratio (RR) 0.49, 95% confidence interval (CI) 0.20 to 1.20); incidence of pneumothorax (RR 0.70, 95% CI 0.24 to 2.05); intraventricular hemorrhage (RR 1.12, 95% CI 0.44 to 2.85); neonatal death (RR 1.40, 95% CI 0.58 to 3.37); and time on ventilation (median time 39 hours in the 12-hourly group and 28 hours in the six-hourly group; RD not applicable for this outcome as mean and standard deviation were not reported). Tests for heterogeneity were not applicable as only one study was included.\nAuthors' conclusions\nThere was insufficient evidence to identify the ideal frequency of ETT suctioning in ventilated neonates. Future research should focus on the effects in the very preterm newborns, that is, the most vulnerable population as concerns the risk of both lung and brain damage. Assessment should include the cases of prolonged ventilation, when more abundant, dense secretions are common. Clinical trials might include comparisons between 'as-scheduled' versus 'as-needed' endotracheal suctioning, that is, based on specific indications, as well frequent versus less frequent suctioning schedules.\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": "Newborns might need help with breathing as their lungs are still maturing. An airway catheter (tube) is inserted into the mouth or nose in order to maintain an open airway (patency) in newborns who are unable to breathe on their own. This procedure is called endotracheal intubation. Endotracheal tube suction is necessary to clear secretions and to maintain airway patency, therefore ensuring that the baby receives enough oxygen. The goal of endotracheal intubation suction should be remove as much of the secretions as possible with minimal side effects associated with the procedure. However, suctioning causes stress, pain, and inflammation (swelling) of the windpipe in newborns. The optimal frequency of suctioning has not been defined. Suctioning inside the airway tube might be performed 'as scheduled' by the specialist or only 'as needed'. Moreover, the 'as scheduled' approach might be more or less frequent. We explored the current evidence, up to October 2015, supporting one schedule or another."
}
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query-laysum | 4584 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is one of the most common genetic disorders. Sickle cell crises in which irregular and dehydrated cells contribute to blocking of blood vessels are characterised by episodes of pain. Treatment is mainly supportive and symptomatic. In vitro studies with piracetam indicate that it has the potential for inhibition and a reversal of the process of sickling of erythrocytes. This is an update of a previously published Cochrane review.\nObjectives\nTo assess the effectiveness of piracetam for reducing the incidence of painful sickle cell disease crises.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.\nLast search of the Group's Haemoglobinopathies Trials Register: 21 September 2015.\nSelection criteria\nRandomised controlled trials comparing orally administered piracetam to placebo or standard care in people, of all ages and both sexes, with sickle cell disease.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. Trial authors were contacted for additional information. Adverse effects data were collected from the trials.\nMain results\nThree trials involving 169 participants were included in the review. A limited amount of data addressing some of the primary and some of the secondary outcomes were provided, but data were incomplete and based on un-validated assumptions used in the evaluation of outcomes. One trial reported a reduction in the number of pain crises and their severity with active intervention than placebo but presented no data to confirm these results. A second trial presented a monthly global pain score based on the number of sickle cell crises and severity of pain but included no separate data for these primary outcomes. Although there was no significant difference between the piracetam and placebo periods for the number of days of hospitalisation (P = 0.87) in one trial, inconsistencies in the criteria necessary for hospitalisation during sickle crises did not permit accurate conclusions to be drawn. Two of the trials reported participant satisfaction with piracetam but provided no details as to how this satisfaction had been assessed. There were no reports of toxicity or adverse effects with piracetam other than one participant who experienced dizziness.\nAuthors' conclusions\nThe small number of included trials and their poor methodological quality provided insufficient reliable evidence to support the routine use of this medication for preventing the incidence of painful sickle cell disease crises.\nWe will continue to run searches to identify any potentially relevant trials; however, we do not plan to update other sections of the review until new trials are published.\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": "Sickle cell disease is one of the most common genetic disorders and affects about 250 million people (5% of the world's population). It is characterised by sickle-shaped red blood cells which may block blood vessels. This can lead to pain and damage to the major organs such as the brain, liver and spleen. Standard care is mainly supportive and in response to symptoms. Pain is controlled with drugs for pain relief and fluids to improve fluid levels. In vitro studies with piracetam have shown that it hinders the bonding of sickle haemoglobin and the bunching together of platelets. It also makes the blood less sticky and red blood cells more flexible."
}
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query-laysum | 4585 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis (TB) requires at least six months of treatment. If treatment is incomplete, patients may not be cured and drug resistance may develop. Directly Observed Therapy (DOT) is a specific strategy, endorsed by the World Health Organization, to improve adherence by requiring health workers, community volunteers or family members to observe and record patients taking each dose.\nObjectives\nTo evaluate DOT compared to self-administered therapy in people on treatment for active TB or on prophylaxis to prevent active disease. We also compared the effects of different forms of DOT.\nSearch methods\nWe searched the following databases up to 13 January 2015: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS and mRCT. We also checked article reference lists and contacted relevant researchers and organizations.\nSelection criteria\nRandomized controlled trials (RCTs) and quasi-RCTs comparing DOT with routine self-administration of treatment or prophylaxis at home.\nData collection and analysis\nTwo review authors independently assessed risk of bias of each included trial and extracted data. We compared interventions using risk ratios (RR) with 95% confidence intervals (CI). We used a random-effects model if meta-analysis was appropriate but heterogeneity present (I2 statistic > 50%). We assessed the quality of the evidence using the GRADE approach.\nMain results\nEleven trials including 5662 participants met the inclusion criteria. DOT was performed by a range of people (nurses, community health workers, family members or former TB patients) in a variety of settings (clinic, the patient's home or the home of a community volunteer).\nDOT versus self-administered\nSix trials from South Africa, Thailand, Taiwan, Pakistan and Australia compared DOT with self-administered therapy for treatment. Trials included DOT at home by family members, community health workers (who were usually supervised); DOT at home by health staff; and DOT at health facilities. TB cure was low with self-administration across all studies (range 41% to 67%), and direct observation did not substantially improve this (RR 1.08, 95% CI 0.91 to 1.27; five trials, 1645 participants, moderate quality evidence). In a subgroup analysis stratified by the frequency of contact between health services in the self-treatment arm, daily DOT may improve TB cure when compared to self-administered treatment where patients in the self-administered group only visited the clinic every month (RR 1.15, 95% CI 1.06 to 1.25; two trials, 900 participants); but with contact in the control becoming more frequent, this small effect was not apparent (every two weeks: RR 0.96, 95% CI 0.83 to 1.12; one trial, 497 participants; every week: RR 0.90, 95% CI 0.68 to 1.21; two trials, 248 participants).\nTreatment completion showed a similar pattern, ranging from 59% to 78% in the self-treatment groups, and direct observation did not improve this (RR 1.07, 95% CI 0.96 to 1.19; six trials, 1839 participants, moderate quality evidence).\nDOT at home versus DOT at health facility\nIn four trials that compared DOT at home by family members, or community health workers, with DOT by health workers at a health facility there was little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.88 to 1.18, four trials, 1556 participants, moderate quality evidence; treatment completion: RR 1.04, 95% CI 0.91 to 1.17, three trials, 1029 participants, moderate quality evidence).\nDOT by family member versus DOT by community health worker\nTwo trials compared DOT at home by family members with DOT at home by community health workers. There was also little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.86 to 1.21; two trials, 1493 participants, moderate quality evidence; completion: RR 1.05, 95% CI 0.90 to 1.22; two trials, 1493 participants, low quality evidence).\nSpecific patient categories\nA trial of 300 intravenous drug users in the USA evaluated direct observation with no observation in TB prophylaxis to prevent active disease and showed little difference in treatment completion (RR 1.00, 95% CI 0.88 to 1.13; one trial, 300 participants, low quality evidence).\nAuthors' conclusions\nFrom the existing trials, DOT did not provide a solution to poor adherence in TB treatment. Given the large resource and cost implications of DOT, policy makers might want to reconsider strategies that depend on direct observation. Other options might take into account financial and logistical barriers to care; approaches that motivate patients and staff; and defaulter follow-up.\n\nGiven the provided abstract, please respond to the following query: \"What is DOT and how might it improve treatment outcomes for people with TB\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "DOT is one strategy to ensure that patients with TB take all their medication. An 'observer' acceptable to the patient and the health system observes the patient taking every dose of their medication, and records this for the health system to monitor.\nThe World Health Organization currently recommends that people with TB are treated for at least six months to achieve cure. These long durations of treatment can be difficult for patients to complete, especially once they are well and need to return to work. Failure to complete treatment can lead to relapse and even death in individuals, and also has important public health consequences, such as increased TB transmission and the development of drug resistance."
}
]
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query-laysum | 4586 | [
{
"role": "user",
"content": "Abstract: Background\nEvidence indicates that reducing dietary salt may reduce the incidence of heart disease and delay decline in kidney function in people with chronic kidney disease (CKD). This is an update of a review first published in 2015.\nObjectives\nTo evaluate the benefits and harms of altering dietary salt for adults with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 6 October 2020 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\nRandomised controlled trials comparing two or more levels of salt intake in adults with any stage of CKD.\nData collection and analysis\nTwo authors independently assessed studies for eligibility, conducted risk of bias evaluation and evaluated confidence in the evidence using GRADE. Results were summarised using random effects models as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI).\nMain results\nWe included 21 studies (1197 randomised participants), 12 in the earlier stages of CKD (779 randomised participants), seven in dialysis (363 randomised participants) and two in post-transplant (55 randomised participants). Selection bias was low in seven studies, high in one and unclear in 13. Performance and detection biases were low in four studies, high in two, and unclear in 15. Attrition and reporting biases were low in 10 studies, high in three and unclear in eight.\nBecause duration of the included studies was too short (1 to 36 weeks) to test the effect of salt restriction on endpoints such as death, cardiovascular events or CKD progression, changes in salt intake on blood pressure and other secondary risk factors were examined.\nReducing salt by mean -73.51 mmol/day (95% CI -92.76 to -54.27), equivalent to 4.2 g or 1690 mg sodium/day, reduced systolic/diastolic blood pressure by -6.91/-3.91 mm Hg (95% CI -8.82 to -4.99/-4.80 to -3.02; 19 studies, 1405 participants; high certainty evidence). Albuminuria was reduced by 36% (95% CI 26 to 44) in six studies, five of which were carried out in people in the earlier stages of CKD (MD -0.44, 95% CI -0.58 to -0.30; 501 participants; high certainty evidence). The evidence is very uncertain about the effect of lower salt intake on weight, as the weight change observed (-1.32 kg, 95% CI -1.94 to -0.70; 12 studies, 759 participants) may have been due to fluid volume, lean tissue, or body fat. Lower salt intake may reduce extracellular fluid volume in the earlier stages of CKD (-0.87 L, 95% CI -1.17 to -0.58; 3 studies; 187 participants; low certainty evidence). The evidence is very uncertain about the effect of lower salt intake on reduction in antihypertensive dose (RR 2.45, 95% CI 0.98 to 6.08; 8 studies; 754 participants). Lower salt intake may lead to symptomatic hypotension (RR 6.70, 95% CI 2.40 to 18.69; 6 studies; 678 participants; moderate certainty evidence). Data were sparse for other types of adverse events.\nAuthors' conclusions\nWe found high certainty evidence that salt reduction reduced blood pressure in people with CKD, and albuminuria in people with earlier stage CKD in the short-term. If such reductions could be maintained long-term, this effect may translate to clinically significant reductions in CKD progression and cardiovascular events. Research into the long-term effects of sodium-restricted diet for people with CKD is warranted.\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": "We found that reducing salt intake reduced risk factors for heart disease and worsening kidney function in people with CKD in the short term. We could not find evidence of the longer term effects of reducing salt intake, which meant we were unable to determine the direct effects of salt intake on death, heart disease, or need for dialysis or kidney transplantation. We need more high quality research in these areas."
}
]
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query-laysum | 4587 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2016. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.\nWorldwide, carbamazepine and phenobarbitone are commonly used broad-spectrum antiepileptic drugs, suitable for most epileptic seizure types. Carbamazepine is a current first-line treatment for focal onset seizures, and is used in the USA and Europe. Phenobarbitone is no longer considered a first-line treatment because of concerns over associated adverse events, particularly documented behavioural adverse events in children treated with the drug. However, phenobarbitone is still commonly used in low- and middle-income countries because of its low cost. No consistent differences in efficacy have been found between carbamazepine and phenobarbitone in individual trials; however, the confidence intervals generated by these trials are wide, and therefore, synthesising the data of the individual trials may show differences in efficacy.\nObjectives\nTo review the time to treatment failure, remission and first seizure with carbamazepine compared with phenobarbitone when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nFor the latest update, we searched the following databases on 24 May 2018: the Cochrane Register of Studies (CRS Web), which includes Cochrane Epilepsy's Specialized Register and CENTRAL; MEDLINE; the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov); and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators, and experts in the field.\nSelection criteria\nRandomised controlled trials comparing monotherapy with either carbamazepine or phenobarbitone in children or adults with focal onset seizures or generalised onset tonic-clonic seizures.\nData collection and analysis\nThis was an individual participant data (IPD), review. Our primary outcome was time to treatment failure. Our secondary outcomes were time to first seizure post-randomisation, time to six-month remission, time to 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs), with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nWe included 13 trials in this review and IPD were available for 836 individuals out of 1455 eligible individuals from six trials, 57% of the potential data. For remission outcomes, a HR of less than 1 indicates an advantage for phenobarbitone and for first seizure and treatment failure outcomes a HR of less than 1 indicates an advantage for carbamazepine.\nResults for the primary outcome of the review were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type for 676 participants: 0.66, 95% CI 0.50 to 0.86, moderate-quality evidence), time to treatment failure due to adverse events (pooled HR adjusted for seizure type for 619 participants: 0.69, 95% CI 0.49 to 0.97, low-quality evidence), time to treatment failure due to lack of efficacy (pooled HR adjusted for seizure type for 487 participants: 0.54, 95% CI 0.38 to 0.78, moderate-quality evidence), showing a statistically significant advantage for carbamazepine compared to phenobarbitone.\nFor our secondary outcomes, we did not find any statistically significant differences between carbamazepine and phenobarbitone: time to first seizure post-randomisation (pooled HR adjusted for seizure type for 822 participants: 1.13, 95% CI 0.93 to 1.38, moderate-quality evidence), time to 12-month remission (pooled HR adjusted for seizure type for 683 participants: 1.09, 95% CI 0.84 to 1.40, low-quality evidence), and time to six-month remission pooled HR adjusted for seizure type for 683 participants: 1.01, 95% CI 0.81 to 1.24, low-quality evidence).\nResults of these secondary outcomes suggest that there may be an association between treatment effect in terms of efficacy and seizure type; that is, that participants with focal onset seizures experience seizure recurrence later and hence remission of seizures earlier on phenobarbitone than carbamazepine, and vice versa for individuals with generalised seizures. It is likely that the analyses of these outcomes were confounded by several methodological issues and misclassification of seizure type, which could have introduced the heterogeneity and bias into the results of this review.\nLimited information was available regarding adverse events in the trials and we could not compare the rates of adverse events between carbamazepine and phenobarbitone. Some adverse events reported on both drugs were abdominal pain, nausea, and vomiting, drowsiness, motor and cognitive disturbances, dysmorphic side effects (such as rash), and behavioural side effects in three paediatric trials.\nAuthors' conclusions\nModerate-quality evidence from this review suggests that carbamazepine is likely to be a more effective drug than phenobarbitone in terms of treatment retention (treatment failures due to lack of efficacy or adverse events or both). Moderate- to low-quality evidence from this review also suggests an association between treatment efficacy and seizure type in terms of seizure recurrence and seizure remission, with an advantage for phenobarbitone for focal onset seizures and an advantage for carbamazepine for generalised onset seizures.\nHowever, some of the trials contributing to the analyses had methodological inadequacies and inconsistencies that may have impacted upon the results of this review. Therefore, we do not suggest that results of this review alone should form the basis of a treatment choice for a patient with newly onset seizures. We recommend that future trials should be designed to the highest quality possible with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to compare how effective these drugs are at controlling seizures, to find out if they are associated with side effects that may result in individuals stopping the medication, and to inform a choice between these medications."
}
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query-laysum | 4588 | [
{
"role": "user",
"content": "Abstract: Background\nDuring intensive care unit (ICU) admission, patients experience extreme physical and psychological stressors, including the abnormal ICU environment. These experiences impact on a patient’s recovery from critical illness and may result in both physical and psychological disorders. One strategy that has been developed and implemented by clinical staff to treat the psychological distress prevalent in ICU survivors is the use of patient diaries. These provide a background to the cause of the patient’s ICU admission and an ongoing narrative outlining day-to-day activities.\nObjectives\nTo assess the effect of a diary versus no diary on patients, and their caregivers or families, during the patient's recovery from admission to an ICU.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1), Ovid MEDLINE (1950 to January 2014), EBSCOhost CINAHL (1982 to January 2014), Ovid EMBASE (1980 to January 2014), PsycINFO (1950 to January 2014), Published International Literature on Traumatic Stress (PILOTS) database (1971 to January 2014); Web of Science Conference Proceedings Citation Index - Science and Social Science and Humanities (1990 to January 2014); seven clinical trial registries and reference lists of identified trials. We applied no language restriction.\nSelection criteria\nWe included randomized controlled trials (RCTs) or clinical controlled trials (CCTs) that evaluated the effectiveness of patient diaries, when compared to no ICU diary, for patients or family members to promote recovery after admission to ICU. Outcome measures for describing recovery from ICU included the risk of post-traumatic stress disorder (PTSD), anxiety, depression and post-traumatic stress symptomatology, health-related quality of life and costs.\nData collection and analysis\nWe used standard methodological approaches as expected by The Cochrane Collaboration. Two review authors independently reviewed titles for inclusion, extracted data and undertook risk of bias according to prespecified criteria.\nMain results\nWe identified three eligible studies; two describing ICU patients (N = 358), and one describing relatives of ICU patients (N = 30). The study involving relatives of ICU patients was a substudy of family members from one of the ICU patient studies. There was a mixed risk of bias within the included studies. Blinding of participants to allocation was not possible and blinding of the outcome assessment was not adequately achieved or reported. Overall the quality of the evidence was low to very low. The patient diary intervention was not identical between studies. However, each provided a prospectively prepared, day-to-day description of the participants' ICU admission.\nNo study adequately reported on risk of PTSD as described using a clinical interview, family or caregiver anxiety or depression, health-related quality of life or costs. Within a single study there was no clear evidence of a difference in risk for developing anxiety (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.07 to 1.19) or depression (RR 0.38, 95% CI 0.12 to 1.19) in participants who received ICU diaries, in comparison to those that did not receive a patient diary. However, the results were imprecise and consistent with benefit in either group, or no difference. Within a single study there was no evidence of difference in median post-traumatic stress symptomatology scores (diaries 24, SD 11.6; no diary 24, SD 11.6) and delusional ICU memory recall (RR 1.04, 95% CI 0.84 to 1.28) between the patients recovering from ICU admission who received patient diaries, and those who did not. One study reported reduced post-traumatic stress symptomatology in family members of patients recovering from admission to ICU who received patient diaries (median 19; range 14 to 28), in comparison to no diary (median 28; range 14 to 38).\nAuthors' conclusions\nCurrently there is minimal evidence from RCTs of the benefits or harms of patient diaries for patients and their caregivers or family members. A small study has described their potential to reduce post-traumatic stress symptomatology in family members. However, there is currently inadequate evidence to support their effectiveness in improving psychological recovery after critical illness for patients and their family members.\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 studies that had reported the risk of post-traumatic stress disorder in patients recovering from admission to ICU using a structured clinical interview.\nThe other primary outcome measures of anxiety and depression were described in one study of 36 patients. In this study no clear evidence of a difference was seen in anxiety and depression when patient diaries were used for people recovering from ICU admission, in comparison to no diaries. Post-traumatic stress symptoms in family members and caregivers were reduced in another study of 30 people when patient diaries were used, in comparison to no diaries.\nCurrent research has not adequately assessed the safety and effectiveness of patient diaries. Adverse events associated with the use of diaries have not been reported. It has not been established whether patient diaries are an effective practice or whether they may cause harm."
}
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query-laysum | 4589 | [
{
"role": "user",
"content": "Abstract: Background\nIdentifying and approaching eligible participants for recruitment to research studies usually relies on healthcare professionals. This process is sometimes hampered by deliberate or inadvertent gatekeeping that can introduce bias into patient selection.\nObjectives\nOur primary objective was to identify and assess the effect of strategies designed to help healthcare professionals to recruit participants to research studies.\nSearch methods\nWe performed searches on 5 January 2015 in the following electronic databases: Cochrane Methodology Register, CENTRAL, MEDLINE, EMBASE, CINAHL, British Nursing Index, PsycINFO, ASSIA and Web of Science (SSCI, SCI-EXPANDED) from 1985 onwards. We checked the reference lists of all included studies and relevant review articles and did citation tracking through Web of Science for all included studies.\nSelection criteria\nWe selected all studies that evaluated a strategy to identify and recruit participants for research via healthcare professionals and provided pre-post comparison data on recruitment rates.\nData collection and analysis\nTwo review authors independently screened search results for potential eligibility, read full papers, applied the selection criteria and extracted data. We calculated risk ratios for each study to indicate the effect of each strategy.\nMain results\nEleven studies met our eligibility criteria and all were at medium or high risk of bias. Only five studies gave the total number of participants (totalling 7372 participants). Three studies used a randomised design, with the others using pre-post comparisons. Several different strategies were investigated. Four studies examined the impact of additional visits or information for the study site, with no increases in recruitment demonstrated. Increased recruitment rates were reported in two studies that used a dedicated clinical recruiter, and five studies that introduced an automated alert system for identifying eligible participants. The studies were embedded into trials evaluating care in oncology mainly but also in emergency departments, diabetes and lower back pain.\nAuthors' conclusions\nThere is no strong evidence for any single strategy to help healthcare professionals to recruit participants in research studies. Additional visits or information did not appear to increase recruitment by healthcare professionals. The most promising strategies appear to be those with a dedicated resource (e.g. a clinical recruiter or automated alert system) for identifying suitable participants that reduced the demand on healthcare professionals, but these were assessed in studies at high risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"Findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 11 studies that assessed recruitment strategies used with healthcare staff in search of the literature in January 2015. Five included the total number of participants (7372). There were three main strategies:\n1. Using an alert system, either a computer system or member of staff to check patient records, to alert staff recruiting participants that someone might be suitable for the study (five studies).\n2. Giving additional information about the study to the staff at hospitals or clinics who are recruiting people through visits from the researchers, educational seminars or leaflets (four studies).\n3. Using a designated member of staff whose primary role was to recruit participants (two studies).\nAll the studies identified were of quite low quality, so it is difficult to draw firm conclusions from them. Five studies examined the alert system to identify participants who might be suitable for a study. Alert systems showed some promising results but were not unanimous in their findings. The four studies that evaluated the provision of additional information, visits or education to the sites recruiting participants found that none of the tested strategies led to improved recruitment. The most promising strategy appears to be the employment of someone such as a clinical trials officer or research nurse with the specific task of recruiting participants to research studies. The two studies using this strategy showed improvement in recruitment rates but both were at high risk of bias."
}
]
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query-laysum | 4590 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes mellitus, a metabolic disorder characterised by hyperglycaemia and associated with a heavy burden of microvascular and macrovascular complications, frequently remains undiagnosed. Screening of apparently healthy individuals may lead to early detection and treatment of type 2 diabetes mellitus and may prevent or delay the development of related complications.\nObjectives\nTo assess the effects of screening for type 2 diabetes mellitus.\nSearch methods\nWe searched CENTRAL, MEDLINE, LILACS, the WHO ICTRP, and ClinicalTrials.gov from inception. The date of the last search was May 2019 for all databases. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials involving adults and children without known diabetes mellitus, conducted over at least three months, that assessed the effect of diabetes screening (mass, targeted, or opportunistic) compared to no diabetes screening.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for potential relevance and reviewed the full-texts of potentially relevant studies, extracted data, and carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool. We assessed the overall certainty of the evidence using the GRADE approach.\nMain results\nWe screened 4651 titles and abstracts identified by the search and assessed 92 full-texts/records for inclusion. We included one cluster-randomised trial, the ADDITION-Cambridge study, which involved 20,184 participants from 33 general practices in Eastern England and assessed the effects of inviting versus not inviting high-risk individuals to screening for diabetes. The diabetes risk score was used to identify high-risk individuals; it comprised variables relating to age, sex, body mass index, and the use of prescribed steroid and anti-hypertensive medication. Twenty-seven practices were randomised to the screening group (11,737 participants actually attending screening) and 5 practices to the no-screening group (4137 participants). In both groups, 36% of participants were women; the average age of participants was 58.2 years in the screening group and 57.9 years in the no-screening group. Almost half of participants in both groups were on antihypertensive medication. The findings from the first phase of this study indicate that screening compared to no screening for type 2 diabetes did not show a clear difference in all-cause mortality (hazard ratio (HR) 1.06, 95% confidence interval (CI) 0.90 to 1.25, low-certainty evidence). Screening compared to no screening for type 2 diabetes mellitus showed an HR of 1.26, 95% CI 0.75 to 2.12 (low-certainty evidence) for diabetes-related mortality (based on whether diabetes was reported as a cause of death on the death certificate). Diabetes-related morbidity and health-related quality of life were only reported in a subsample and did not show a substantial difference between the screening intervention and control. The included study did not report on adverse events, incidence of type 2 diabetes, glycosylated haemoglobin A1c (HbA1c), and socioeconomic effects.\nAuthors' conclusions\nWe are uncertain about the effects of screening for type 2 diabetes on all-cause mortality and diabetes-related mortality. Evidence was available from one study only. We are therefore unable to draw any firm conclusions relating to the health outcomes of early type 2 diabetes mellitus screening. Furthermore, the included study did not assess all of the outcomes prespecified in the review (diabetes-related morbidity, incidence of type 2 diabetes, health-related quality of life, adverse events, socioeconomic effects).\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We based the certainty of the evidence on only one study. The overall certainty of the results from this study is low, because the results are not precise, that is they could change in any direction if new studies are published."
}
]
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query-laysum | 4591 | [
{
"role": "user",
"content": "Abstract: Background\nThe strain on public resources to meet the healthcare needs of populations through publicly-provided health insurance programmes is increasing and many governments turn to private health insurance (PHI) to ease the pressure on government budgets. With the goal of improving access to basic health care for citizens through PHI programmes, several high-income countries have developed strong regulations for PHI schemes. Low- and middle-income countries have the opportunity to learn from this experience to optimise PHI. If poorly regulated, PHI can hardly achieve an adequate quantity or quality of population coverage, as can be seen in the USA where a third of adults younger than 65 years of age have no insurance, sporadic coverage or coverage that exposes them to high out-of-pocket healthcare costs.\nObjectives\nTo assess the effects of policies that regulate private health insurance on utilisation, quality, and cost of health care provided.\nSearch methods\nIn November 2019 we searched CENTRAL; MEDLINE; Embase; Sociological Abstracts and Social Services Abstracts; ICTRP; ClinicalTrials.gov; and Web of Science Core Collection for papers that have cited the included studies. This complemented the search conducted in February 2017 in IBSS; EconLit; and Global Health. We also searched selected grey literature databases and web-sites.\nSelection criteria\nRandomised trials, non-randomised trials, interrupted time series (ITS) studies, and controlled before-after (CBA) studies conducted in any population or setting that assessed one or more of the following interventions that governments use to regulate private health insurance: legislation and licensing, monitoring, auditing, and intelligence.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed risk of bias and certainty of the evidence resolving discrepancies by consensus. We planned to summarise the results (using random-effects or fixed-effect meta-analysis) to produce an overall summary if an average intervention effect across studies was considered meaningful, and we would have discussed the implications of any differences in intervention effects across studies. However, due to the nature of the data obtained, we have provided a narrative synthesis of the findings.\nMain results\nWe included seven CBA studies, conducted in the USA, and that directly assessed state laws on cancer screening. Only for-profit PHI schemes were addressed in the included studies and no study addressed other types of PHI (community and not for-profit). The seven studies were assessed as having 'unclear risk' of bias. All seven studies reported on utilisation of healthcare services, and one study reported on costs. None of the included studies reported on quality of health care and patient health outcomes. We assessed the certainty of evidence for patient health outcomes, and utilisation and costs of healthcare services as very low. Therefore, we are uncertain of the effects of government mandates on for-profit PHI schemes.\nAuthors' conclusions\nOur review suggests that, from currently available evidence, it is uncertain whether policies that regulate private health insurance have an effect on utilisation of healthcare services, costs, quality of care, or patient health outcomes. The findings come from studies conducted in the USA and might therefore not be applicable to other countries; since the regulatory environment could be different.\nStudies are required in countries at different income levels because the effects of government regulation of PHI are likely to differ across these income and health system settings. Further studies should assess the different types of regulation (including regulation and licensing, monitoring, auditing, and intelligence). While regulatory research on PHI remains relatively scanty, future research can draw on the rich body of research on the regulation of other health financing interventions such as user fees and results-based provider payments.\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": "We do not know what the effect of government regulations on private health insurance is as the evidence was of very low certainty. We need more studies from different settings, assessing different types of regulations, and different types of private health insurance."
}
]
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query-laysum | 4592 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory morbidity including respiratory distress syndrome (RDS) is a serious complication of preterm birth and the primary cause of early neonatal mortality and disability. Despite early evidence indicating a beneficial effect of antenatal corticosteroids on fetal lung maturation and widespread recommendations to use this treatment in women at risk of preterm delivery, some uncertainty remains about their effectiveness particularly with regard to their use in lower-resource settings, different gestational ages and high-risk obstetric groups such as women with hypertension or multiple pregnancies.\nThis updated review (which supersedes an earlier review Crowley 1996) was first published in 2006 and subsequently updated in 2017.\nObjectives\nTo assess the effects of administering a course of corticosteroids to women prior to anticipated preterm birth (before 37 weeks of pregnancy) on fetal and neonatal morbidity and mortality, maternal mortality and morbidity, and on the child in later life.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (3 September 2020), ClinicalTrials.gov, the databases that contribute to the WHO International Clinical Trials Registry Platform (ICTRP) (3 September 2020), and reference lists of the retrieved studies.\nSelection criteria\nWe considered all randomised controlled comparisons of antenatal corticosteroid administration with placebo, or with no treatment, given to women with a singleton or multiple pregnancy, prior to anticipated preterm delivery (elective, or following rupture of membranes or spontaneous labour), regardless of other co-morbidity, for inclusion in this review.\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. Primary outcomes included perinatal death, neonatal death, RDS, intraventricular haemorrhage (IVH), birthweight, developmental delay in childhood and maternal death.\nMain results\nWe included 27 studies (11,272 randomised women and 11,925 neonates) from 20 countries. Ten trials (4422 randomised women) took place in lower- or middle-resource settings.\nWe removed six trials from the analysis that were included in the previous version of the review; this review only includes trials that meet our pre-defined trustworthiness criteria. In 19 trials the women received a single course of steroids. In the remaining eight trials repeated courses may have been prescribed.\nFifteen trials were judged to be at low risk of bias, two had a high risk of bias in two or more domains and ten trials had a high risk of bias due to lack of blinding (placebo was not used in the control arm.\nOverall, the certainty of evidence was moderate to high, but it was downgraded for IVH due to indirectness; for developmental delay due to risk of bias and for maternal adverse outcomes (death, chorioamnionitis and endometritis) due to imprecision.\nNeonatal/child outcomes\nAntenatal corticosteroids reduce the risk of:\n- perinatal death (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.77 to 0.93; 9833 infants; 14 studies; high-certainty evidence; 2.3% fewer, 95% CI 1.1% to 3.6% fewer),\n- neonatal death (RR 0.78, 95% CI 0.70 to 0.87; 10,609 infants; 22 studies; high-certainty evidence; 2.6% fewer, 95% CI 1.5% to 3.6% fewer),\n- respiratory distress syndrome (RR 0.71, 95% CI 0.65 to 0.78; 11,183 infants; studies = 26; high-certainty evidence; 4.3% fewer, 95% CI 3.2% to 5.2% fewer).\nAntenatal corticosteroids probably reduce the risk of IVH (RR 0.58, 95% CI 0.45 to 0.75; 8475 infants; 12 studies; moderate-certainty evidence; 1.4% fewer, 95% CI 0.8% to1.8% fewer), and probably have little to no effect on birthweight (mean difference (MD) -14.02 g, 95% CI -33.79 to 5.76; 9551 infants; 19 studies; high-certainty evidence).\nAntenatal corticosteroids probably lead to a reduction in developmental delay in childhood (RR 0.51, 95% CI 0.27 to 0.97; 600 children; 3 studies; moderate-certainty evidence; 3.8% fewer, 95% CI 0.2% to 5.7% fewer).\nMaternal outcomes\nAntenatal corticosteroids probably result in little to no difference in maternal death (RR 1.19, 95% CI 0.36 to 3.89; 6244 women; 6 studies; moderate-certainty evidence; 0.0% fewer, 95% CI 0.1% fewer to 0.5% more), chorioamnionitis (RR 0.86, 95% CI 0.69 to 1.08; 8374 women; 15 studies; moderate-certainty evidence; 0.5% fewer, 95% CI 1.1% fewer to 0.3% more), and endometritis (RR 1.14, 95% CI 0.82 to 1.58; 6764 women; 10 studies; moderate-certainty; 0.3% more, 95% CI 0.3% fewer to 1.1% more)\nThe wide 95% CIs in all of these outcomes include possible benefit and possible harm.\nAuthors' conclusions\nEvidence from this updated review supports the continued use of a single course of antenatal corticosteroids to accelerate fetal lung maturation in women at risk of preterm birth. Treatment with antenatal corticosteroids reduces the risk of perinatal death, neonatal death and RDS and probably reduces the risk of IVH. This evidence is robust, regardless of resource setting (high, middle or low).\nFurther research should focus on variations in the treatment regimen, effectiveness of the intervention in specific understudied subgroups such as multiple pregnancies and other high-risk obstetric groups, and the risks and benefits in the very early or very late preterm periods. Additionally, outcomes from existing trials with follow-up into childhood and adulthood are needed in order to investigate any longer-term effects of antenatal corticosteroids.\nWe encourage authors of previous studies to provide further information which may answer any remaining questions about the use of antenatal corticosteroids without the need for further randomised controlled trials. Individual patient data meta-analyses from published trials are likely to provide answers for most of the remaining clinical uncertainties.\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 studies that compared the effects of corticosteroids against:\n- a placebo (dummy) treatment; or\n- no treatment.\nWe compared the results and summarised the evidence from all the studies. We rated our confidence in the evidence, based on factors such as study methods and sizes, and the consistency of findings across studies."
}
]
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query-laysum | 4593 | [
{
"role": "user",
"content": "Abstract: Background\nThe emigration of skilled professionals from low- and middle-income countries (LMICs) to high-income countries (HICs) is a general phenomenon but poses particular challenges in health care, where it contributes to human resource shortages in the health systems of poorer countries. However, little is known about the effects of strategies to help regulate this movement.\nObjectives\nTo assess the effects of policy interventions to regulate emigration of health professionals from LMICs.\nSearch methods\nWe searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 15 March 2011), the Cochrane Register of Controlled Trials (CENTRAL) (searched 2 March 2011), MEDLINE (searched 5 March 2011), EMBASE (searched 2 March 2011), CINAHL (searched 5 March 2011), LILACS (searched 7 March 2011), WHOLIS (searched 20 March 2011), SocINDEX (searched 11 March 2011), EconLit (searched 8 March 2011), Science and Social Science Citation Index (searched 8 March 2011), NLM Gateway (searched 31 March 2011) and ERIC (searched March 3 2011). We reviewed reference lists of included studies and selected reviews on the topic, contacted authors of included studies and experts on the field, and reviewed relevant websites.\nSelection criteria\nRandomised controlled trials (RCT), non-randomised controlled trials (NRCT), controlled before-and-after studies (CBA) and interrupted time series (ITS) studies assessing any intervention in the source, the recipient or both countries that could have an impact on the number of professionals that emigrate from a LMIC. Health professionals, such as physicians, dentists, nurses or midwives, should be nationals of a LMIC whose graduate training was in a LMIC.\nData collection and analysis\nOne review author extracted data onto a standard form and a second review author checked data. Two review authors assessed risk of bias.\nMain results\nOnly one study was included. This time series study assessed the migration of Philippine nurses to the United States of America (USA) from 1954 to 1990. We re-analysed it as an interrupted time series study. The intervention was a modification of migratory law in the US, called the 'Act of October 1965', which decreased the restrictions on Eastern hemisphere immigrants to the USA. The analysis showed a significant immediate increase of 807.6 (95% confidence interval (CI) 480.9 to 1134.3) in the number of nurses migrating to the USA annually after the intervention. This represents a relative increase of 5000% over the underlying pre-intervention trend. There were no significant differences in the slopes of the underlying trends for the number of nurses migrating between the pre- and postintervention periods.\nAuthors' conclusions\nThere is an important gap in knowledge about the effectiveness of policy interventions in either HICs or LMICs that could regulate positively the movement of health professionals from LMICs. The only evidence found was from an intervention in a HIC that increased the movement of health professionals from a LMIC.\nNew initiatives to improve records on the migration of health professionals from LMICs should be implemented, as a prerequisite to conducting more rigorous research in the field. This research should focus on whether the range of interventions outlined in the literature could be effective in retaining health professionals in LMICs. Such interventions include financial rewards, career development and continuing education, improving hospital infrastructure, resource availability, better hospital management and improved recognition of health professionals.\n\nGiven the provided abstract, please respond to the following query: \"What happens when efforts are made to regulate the emigration of health professionals?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In most cases, efforts to regulate health worker migration have not been properly evaluated. The review authors found only one study that met their stated requirements for types of study designs. This study looked at the impact of United States (US) immigration law on the number of nurses emigrating from the Philippines to the USA. US government immigration laws were changed in the 1960s, giving equal access to European and non-European immigrants. The study measured the number of nurses migrating from the Philippines to the USA in the years before and after the law had changed. The study showed that:\n- The change in US immigration laws probably increased the number of nurses migrating from the Philippines to the USA. The quality of this evidence is moderate.\nThe review shows that there is a huge gap in our knowledge about the effectiveness of policy interventions that attempt to regulate the movement of health professionals from low- and middle-income countries.\n"
}
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query-laysum | 4594 | [
{
"role": "user",
"content": "Abstract: Background\nHigh-flow nasal cannulae (HFNC) deliver high flows of blended humidified air and oxygen via wide-bore nasal cannulae and may be useful in providing respiratory support for adults experiencing acute respiratory failure, or at risk of acute respiratory failure, in the intensive care unit (ICU). This is an update of an earlier version of the review.\nObjectives\nTo assess the effectiveness of HFNC compared to standard oxygen therapy, or non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV), for respiratory support in adults in the ICU.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane COVID-19 Register (17 April 2020), clinical trial registers (6 April 2020) and conducted forward and backward citation searches.\nSelection criteria\nWe included randomized controlled studies (RCTs) with a parallel-group or cross-over design comparing HFNC use versus other types of non-invasive respiratory support (standard oxygen therapy via nasal cannulae or mask; or NIV or NIPPV which included continuous positive airway pressure and bilevel positive airway pressure) in adults admitted to the ICU.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included 31 studies (22 parallel-group and nine cross-over designs) with 5136 participants; this update included 20 new studies. Twenty-one studies compared HFNC with standard oxygen therapy, and 13 compared HFNC with NIV or NIPPV; three studies included both comparisons. We found 51 ongoing studies (estimated 12,807 participants), and 19 studies awaiting classification for which we could not ascertain study eligibility information.\nIn 18 studies, treatment was initiated after extubation. In the remaining studies, participants were not previously mechanically ventilated.\nHFNC versus standard oxygen therapy\nHFNC may lead to less treatment failure as indicated by escalation to alternative types of oxygen therapy (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.45 to 0.86; 15 studies, 3044 participants; low-certainty evidence). HFNC probably makes little or no difference in mortality when compared with standard oxygen therapy (RR 0.96, 95% CI 0.82 to 1.11; 11 studies, 2673 participants; moderate-certainty evidence). HFNC probably results in little or no difference to cases of pneumonia (RR 0.72, 95% CI 0.48 to 1.09; 4 studies, 1057 participants; moderate-certainty evidence), and we were uncertain of its effect on nasal mucosa or skin trauma (RR 3.66, 95% CI 0.43 to 31.48; 2 studies, 617 participants; very low-certainty evidence). We found low-certainty evidence that HFNC may make little or no difference to the length of ICU stay according to the type of respiratory support used (MD 0.12 days, 95% CI -0.03 to 0.27; 7 studies, 1014 participants). We are uncertain whether HFNC made any difference to the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) within 24 hours of treatment (MD 10.34 mmHg, 95% CI -17.31 to 38; 5 studies, 600 participants; very low-certainty evidence). We are uncertain whether HFNC made any difference to short-term comfort (MD 0.31, 95% CI -0.60 to 1.22; 4 studies, 662 participants, very low-certainty evidence), or to long-term comfort (MD 0.59, 95% CI -2.29 to 3.47; 2 studies, 445 participants, very low-certainty evidence).\nHFNC versus NIV or NIPPV\nWe found no evidence of a difference between groups in treatment failure when HFNC were used post-extubation or without prior use of mechanical ventilation (RR 0.98, 95% CI 0.78 to 1.22; 5 studies, 1758 participants; low-certainty evidence), or in-hospital mortality (RR 0.92, 95% CI 0.64 to 1.31; 5 studies, 1758 participants; low-certainty evidence). We are very uncertain about the effect of using HFNC on incidence of pneumonia (RR 0.51, 95% CI 0.17 to 1.52; 3 studies, 1750 participants; very low-certainty evidence), and HFNC may result in little or no difference to barotrauma (RR 1.15, 95% CI 0.42 to 3.14; 1 study, 830 participants; low-certainty evidence). HFNC may make little or no difference to the length of ICU stay (MD -0.72 days, 95% CI -2.85 to 1.42; 2 studies, 246 participants; low-certainty evidence). The ratio of PaO2/FiO2 may be lower up to 24 hours with HFNC use (MD -58.10 mmHg, 95% CI -71.68 to -44.51; 3 studies, 1086 participants; low-certainty evidence). We are uncertain whether HFNC improved short-term comfort when measured using comfort scores (MD 1.33, 95% CI 0.74 to 1.92; 2 studies, 258 participants) and responses to questionnaires (RR 1.30, 95% CI 1.10 to 1.53; 1 study, 168 participants); evidence for short-term comfort was very low certainty. No studies reported on nasal mucosa or skin trauma.\nAuthors' conclusions\nHFNC may lead to less treatment failure when compared to standard oxygen therapy, but probably makes little or no difference to treatment failure when compared to NIV or NIPPV. For most other review outcomes, we found no evidence of a difference in effect. However, the evidence was often of low or very low certainty. We found a large number of ongoing studies; including these in future updates could increase the certainty or may alter the direction of these effects.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "HFNC may lead to less treatment failure when compared to standard oxygen therapy, but probably makes little or no difference when compared to NIV or NIPPV. For most other review outcomes, we found no reliable evidence of a difference in effect. However, we identified another 51 ongoing trials and we plan to include these in future updates of the review. When these trials are incorporated, we may reach different conclusions about whether HFNC is helpful for breathing support in adult ICU patients."
}
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query-laysum | 4595 | [
{
"role": "user",
"content": "Abstract: Background\nAntipsychotic-induced weight gain is an extremely common problem in people with schizophrenia and is associated with increased morbidity and mortality. Adjunctive pharmacological interventions may be necessary to help manage antipsychotic-induced weight gain. This review splits and updates a previous Cochrane Review that focused on both pharmacological and behavioural approaches to this problem.\nObjectives\nTo determine the effectiveness of pharmacological interventions for preventing antipsychotic-induced weight gain in people with schizophrenia.\nSearch methods\nThe Cochrane Schizophrenia Information Specialist searched Cochrane Schizophrenia's Register of Trials on 10 February 2021. There are no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that examined any adjunctive pharmacological intervention for preventing weight gain in people with schizophrenia or schizophrenia-like illnesses who use antipsychotic medications.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the quality of included studies. For continuous outcomes, we combined mean differences (MD) in endpoint and change data in the analysis. For dichotomous outcomes, we calculated risk ratios (RR). We assessed risk of bias for included studies and used GRADE to judge certainty of evidence and create summary of findings tables. The primary outcomes for this review were clinically important change in weight, clinically important change in body mass index (BMI), leaving the study early, compliance with treatment, and frequency of nausea. The included studies rarely reported these outcomes, so, post hoc, we added two new outcomes, average endpoint/change in weight and average endpoint/change in BMI.\nMain results\nSeventeen RCTs, with a total of 1388 participants, met the inclusion criteria for the review. Five studies investigated metformin, three topiramate, three H2 antagonists, three monoamine modulators, and one each investigated monoamine modulators plus betahistine, melatonin and samidorphan. The comparator in all studies was placebo or no treatment (i.e. standard care alone). We synthesised all studies in a quantitative meta-analysis. Most studies inadequately reported their methods of allocation concealment and blinding of participants and personnel. The resulting risk of bias and often small sample sizes limited the overall certainty of the evidence. Only one reboxetine study reported the primary outcome, number of participants with clinically important change in weight. Fewer people in the treatment condition experienced weight gains of more than 5% and more than 7% of their bodyweight than those in the placebo group (> 5% weight gain RR 0.27, 95% confidence interval (CI) 0.11 to 0.65; 1 study, 43 participants; > 7% weight gain RR 0.24, 95% CI 0.07 to 0.83; 1 study, 43 participants; very low-certainty evidence). No studies reported the primary outcomes, 'clinically important change in BMI', or 'compliance with treatment'. However, several studies reported 'average endpoint/change in body weight' or 'average endpoint/change in BMI'.\nMetformin may be effective in preventing weight gain (MD −4.03 kg, 95% CI −5.78 to −2.28; 4 studies, 131 participants; low-certainty evidence); and BMI increase (MD −1.63 kg/m2, 95% CI −2.96 to −0.29; 5 studies, 227 participants; low-certainty evidence). Other agents that may be slightly effective in preventing weight gain include H2 antagonists such as nizatidine, famotidine and ranitidine (MD −1.32 kg, 95% CI −2.09 to −0.56; 3 studies, 248 participants; low-certainty evidence) and monoamine modulators such as reboxetine and fluoxetine (weight: MD −1.89 kg, 95% CI −3.31 to −0.47; 3 studies, 103 participants; low-certainty evidence; BMI: MD −0.66 kg/m2, 95% CI −1.05 to −0.26; 3 studies, 103 participants; low-certainty evidence). Topiramate did not appear effective in preventing weight gain (MD −4.82 kg, 95% CI −9.99 to 0.35; 3 studies, 168 participants; very low-certainty evidence). For all agents, there was no difference between groups in terms of individuals leaving the study or reports of nausea. However, the results of these outcomes are uncertain given the very low-certainty evidence.\nAuthors' conclusions\nThere is low-certainty evidence to suggest that metformin may be effective in preventing weight gain. Interpretation of this result and those for other agents, is limited by the small number of studies, small sample size, and short study duration. In future, we need studies that are adequately powered and with longer treatment durations to further evaluate the efficacy and safety of interventions for managing weight gain.\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 any medicine given alongside antipsychotics to prevent weight gain in people with schizophrenia. Study participants could be any age or sex but had to have a diagnosis of schizophrenia or a schizophrenia-like illness. They had to be chosen at random to receive either the weight-prevention medicine, or a placebo (a dummy medicine) or no add-on medicine (standard treatment).\nWe compared and summarised 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 | 4596 | [
{
"role": "user",
"content": "Abstract: Background\nAppendiceal phlegmon and abscess account for 2% to 10% of acute appendicitis. People with appendiceal phlegmon or abscess usually need an appendicectomy to relieve their symptoms and avoid complications. The timing of appendicectomy for appendiceal phlegmon or abscess is controversial.\nObjectives\nTo assess the effects of early versus delayed appendicectomy for appendiceal phlegmon or abscess, in terms of overall morbidity and mortality.\nSearch methods\nWe searched the Cochrane Library (CENTRAL; 2016, Issue 7), MEDLINE Ovid (1950 to 23 August 2016), Embase Ovid (1974 to 23 August 2016), Science Citation Index Expanded (1900 to 23 August 2016), and the Chinese Biomedical Literature Database (CBM) (1978 to 23 August 2016). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform search portal (23 August 2016) and ClinicalTrials.gov (23 August 2016) for ongoing trials.\nSelection criteria\nWe included all individual and cluster-randomised controlled trials, irrespective of language, publication status, or age of participants, comparing early versus delayed appendicectomy in people with appendiceal phlegmon or abscess.\nData collection and analysis\nTwo review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed 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 (CI).\nMain results\nWe included two randomised controlled trials with a total of 80 participants in this review.\n1. Early versus delayed open appendicectomy for appendiceal phlegmon\nForty participants (paediatric and adults) with appendiceal phlegmon were randomised either to early appendicectomy (appendicectomy as soon as appendiceal mass resolved within the same admission) (n = 20), or to delayed appendicectomy (initial conservative treatment followed by interval appendicectomy six weeks later) (n = 20). The trial was at high risk of bias. There was no mortality in either group. There is insufficient evidence to determine the effect of using either early or delayed open appendicectomy onoverall morbidity (RR 13.00; 95% CI 0.78 to 216.39; very low-quality evidence), the proportion of participants who developed wound infection (RR 9.00; 95% CI 0.52 to 156.91; very low quality evidence) or faecal fistula (RR 3.00; 95% CI 0.13 to 69.52; very low quality evidence). The quality of evidence for increased length of hospital stay and time away from normal activities in the early appendicectomy group (MD 6.70 days; 95% CI 2.76 to 10.64, and MD 5.00 days; 95% CI 1.52 to 8.48, respectively) is very low quality evidence. The trial reported neither quality of life nor pain outcomes.\n2. Early versus delayed laparoscopic appendicectomy for appendiceal abscess\nForty paediatric participants with appendiceal abscess were randomised either to early appendicectomy (emergent laparoscopic appendicectomy) (n = 20) or to delayed appendicectomy (initial conservative treatment followed by interval laparoscopic appendicectomy 10 weeks later) (n = 20). The trial was at high risk of bias. The trial did not report on overall morbidity or complications. There was no mortality in either group. We do not have sufficient evidence to determine the effects of using either early or delayed laparoscopic appendicectomy for outcomes relating to hospital stay between the groups (MD −0.20 days; 95% CI −3.54 to 3.14; very low quality of evidence). Health-related quality of life was measured with the Pediatric Quality of Life Scale-Version 4.0 questionnaire (a scale of 0 to 100 with higher values indicating a better quality of life). Health-related quality of life score measured at 12 weeks after appendicectomy was higher in the early appendicectomy group than in the delayed appendicectomy group (MD 12.40 points; 95% CI 9.78 to 15.02) but the quality of evidence was very low. This trial reported neither the pain nor the time away from normal activities.\nAuthors' conclusions\nIt is unclear whether early appendicectomy prevents complications compared to delayed appendicectomy for people with appendiceal phlegmon or abscess. The evidence indicating increased length of hospital stay and time away from normal activities in people with early open appendicectomy is of very low quality. The evidence for better health-related quality of life following early laparoscopic appendicectomy compared with delayed appendicectomy is based on very low quality evidence. For both comparisons addressed in this review, data are sparse, and we cannot rule out significant benefits or harms of early versus delayed appendicectomy.\nFurther trials on this topic are urgently needed and should specify a set of criteria for use of antibiotics, percutaneous drainage of the appendiceal abscess prior to surgery and resolution of the appendiceal phlegmon or abscess. Future trials should include outcomes such as time away from normal activities, quality of life and the length of hospital stay.\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 are the risks and benefits of early versus delayed removal of appendix in people with symptomatic complicated appendicitis?"
}
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query-laysum | 4597 | [
{
"role": "user",
"content": "Abstract: Background\nAcute bronchiolitis is the leading cause of medical emergencies during winter months in infants younger than 24 months old. Chest physiotherapy is sometimes used to assist infants in the clearance of secretions in order to decrease ventilatory effort. This is an update of a Cochrane Review first published in 2005 and updated in 2006, 2012, and 2016.\nObjectives\nTo determine the efficacy of chest physiotherapy in infants younger than 24 months old with acute bronchiolitis. A secondary objective was to determine the efficacy of different techniques of chest physiotherapy (vibration and percussion, passive exhalation, or instrumental).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Web of Science, PEDro (October 2011 to 20 April 2022), and two trials registers (5 April 2022).\nSelection criteria\nRandomised controlled trials (RCTs) in which chest physiotherapy was compared to control (conventional medical care with no physiotherapy intervention) or other respiratory physiotherapy techniques in infants younger than 24 months old with bronchiolitis.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nOur update of the searches dated 20 April 2022 identified five new RCTs with 430 participants. We included a total of 17 RCTs (1679 participants) comparing chest physiotherapy with no intervention or comparing different types of physiotherapy.\nFive trials (246 participants) assessed percussion and vibration techniques plus postural drainage (conventional chest physiotherapy), and 12 trials (1433 participants) assessed different passive flow-oriented expiratory techniques, of which three trials (628 participants) assessed forced expiratory techniques, and nine trials (805 participants) assessed slow expiratory techniques. In the slow expiratory subgroup, two trials (78 participants) compared the technique with instrumental physiotherapy techniques, and two recent trials (116 participants) combined slow expiratory techniques with rhinopharyngeal retrograde technique (RRT). One trial used RRT alone as the main component of the physiotherapy intervention. Clinical severity was mild in one trial, severe in four trials, moderate in six trials, and mild to moderate in five trials. One study did not report clinical severity. Two trials were performed on non-hospitalised participants.\nOverall risk of bias was high in six trials, unclear in five, and low in six trials.\nThe analyses showed no effects of conventional techniques on change in bronchiolitis severity status, respiratory parameters, hours with oxygen supplementation, or length of hospital stay (5 trials, 246 participants).\nRegarding instrumental techniques (2 trials, 80 participants), one trial observed similar results in bronchiolitis severity status when comparing slow expiration to instrumental techniques (mean difference 0.10, 95% confidence interval (C) −0.17 to 0.37).\nForced passive expiratory techniques failed to show an effect on bronchiolitis severity in time to recovery (2 trials, 509 participants; high-certainty evidence) and time to clinical stability (1 trial, 99 participants; high-certainty evidence) in infants with severe bronchiolitis. Important adverse effects were reported with the use of forced expiratory techniques.\nRegarding slow expiratory techniques, a mild to moderate improvement was observed in bronchiolitis severity score (standardised mean difference −0.43, 95% CI −0.73 to −0.13; I2 = 55%; 7 trials, 434 participants; low-certainty evidence). Also, in one trial an improvement in time to recovery was observed with the use of slow expiratory techniques. No benefit was observed in length of hospital stay, except for one trial which showed a one-day reduction. No effects were shown or reported for other clinical outcomes such as duration on oxygen supplementation, use of bronchodilators, or parents' impression of physiotherapy benefit.\nAuthors' conclusions\nWe found low-certainty evidence that passive slow expiratory technique may result in a mild to moderate improvement in bronchiolitis severity when compared to control. This evidence comes mostly from infants with moderately acute bronchiolitis treated in hospital. The evidence was limited with regard to infants with severe bronchiolitis and those with moderately severe bronchiolitis treated in ambulatory settings.\nWe found high-certainty evidence that conventional techniques and forced expiratory techniques result in no difference in bronchiolitis severity or any other outcome. We found high-certainty evidence that forced expiratory techniques in infants with severe bronchiolitis do not improve their health status and can lead to severe adverse effects.\nCurrently, the evidence regarding new physiotherapy techniques such as RRT or instrumental physiotherapy is scarce, and further trials are needed to determine their effects and potential for use in infants with moderate bronchiolitis, as well as the potential additional effect of RRT when combined with slow passive expiratory techniques. Finally, the effectiveness of combining chest physiotherapy with hypertonic saline should also be investigated.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to 20 April 2022."
}
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query-laysum | 4598 | [
{
"role": "user",
"content": "Abstract: Background\nMother-infant proximity and interactions after birth and during the early postpartum period are important for breast-milk production and breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth for the duration of hospitalisation, whereas separate care is keeping the baby in the hospital nursery and the baby is either brought to the mother for breastfeeding or she walks to the nursery.\nObjectives\nTo assess the effect of mother-infant rooming-in versus separation on the duration of breastfeeding (exclusive and total duration of breastfeeding).\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 May 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised or quasi-randomised controlled trials (RCTs) investigating the effect of mother-infant rooming-in versus separate care after hospital birth or at home on the duration of breastfeeding, proportion of breastfeeding at six months and adverse neonatal and maternal outcomes.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion and assessed trial quality. Two review authors extracted data. Data were checked for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included one trial (involving 176 women) in this review. This trial included four groups with a factorial design. The factorial design took into account two factors, i.e. infant location in relation to the mother and the type of infant apparel. We combined three of the groups as the intervention (rooming-in) group and the fourth group acted as the control (separate care) and we analysed the results as a single pair-wise comparison.\nPrimary outcomes\nThe primary outcome, duration of any breastfeeding, was reported by authors as median values because the distribution was found to be skewed. They reported the overall median duration of any breastfeeding to be four months, with no difference found between groups. Duration of exclusive breastfeeding and the proportion of infants being exclusively breastfed at six months of age was not reported in the trial. There was no difference found between the two groups in the proportion of infants receiving any breastfeeding at six months of age (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.51 to 1.39; one trial; 137 women; low-quality evidence).\nSecondary outcomes\nThe mean frequency of breastfeeds per day on day four postpartum for the rooming-in group was 8.3 (standard deviation (SD) 2.2), slightly higher than the separate care group, i.e. seven times per day. However, between-group comparison of this outcome was not appropriate since every infant in the separate care group was breastfed at a fixed schedule of seven times per day (SD = 0) resulting in no estimable comparison. The rate of exclusive breastfeeding on day four postpartum before discharge from hospital was significantly higher in the rooming-in group 86% (99 of 115) compared with separate care group, 45% (17 of 38), (RR 1.92; 95% CI 1.34 to 2.76; one trial, 153 women; low-quality evidence). None of our other pre-specified secondary outcomes were reported.\nAuthors' conclusions\nWe found little evidence to support or refute the practice of rooming-in versus mother-infant separation. Further well-designed RCTs to investigate full mother-infant rooming-in versus partial rooming-in or separate care including all important outcomes are needed.\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": "Keeping mother and infant together (rooming-in) or separating them after birth are both traditional practices seen in many cultures. During the early 20th century when hospitals became the centre for birthing in industrialised countries, the practice of separate care became established. Newborns were placed in a nursery separated from their mothers and brought to their mother only for breastfeeding. The practice of mother-infant rooming-in became less practised. Mother-infant proximity during the early postpartum period might directly influence mother-infant interaction, which might impact on the duration of breastfeeding."
}
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query-laysum | 4599 | [
{
"role": "user",
"content": "Abstract: Background\nSome clinicians believe that routine episiotomy, a surgical cut of the vagina and perineum, will prevent serious tears during childbirth. On the other hand, an episiotomy guarantees perineal trauma and sutures.\nObjectives\nTo assess the effects on mother and baby of a policy of selective episiotomy ('only if needed') compared with a policy of routine episiotomy ('part of routine management') for vaginal births.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (14 September 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing selective versus routine use of episiotomy, irrespective of parity, setting or surgical type of episiotomy. We included trials where either unassisted or assisted vaginal births were intended. Quasi-RCTs, trials using a cross-over design or those published in abstract form only were not eligible for inclusion in this review.\nData collection and analysis\nTwo authors independently screened studies, extracted data, and assessed risk of bias. A third author mediated where there was no clear consensus. We observed good practice for data analysis and interpretation where trialists were review authors. We used fixed-effect models unless heterogeneity precluded this, expressed results as risk ratios (RR) and 95% confidence intervals (CI), and assessed the certainty of the evidence using GRADE.\nMain results\nThis updated review includes 12 studies (6177 women), 11 in women in labour for whom a vaginal birth was intended, and one in women where an assisted birth was anticipated. Two were trials each with more than 1000 women (Argentina and the UK), and the rest were smaller (from Canada, Germany, Spain, Ireland, Malaysia, Pakistan, Columbia and Saudi Arabia). Eight trials included primiparous women only, and four trials were in both primiparous and multiparous women. For risk of bias, allocation was adequately concealed and reported in nine trials; sequence generation random and adequately reported in three trials; blinding of outcomes adequate and reported in one trial, blinding of participants and personnel reported in one trial.\nFor women where an unassisted vaginal birth was anticipated, a policy of selective episiotomy may result in 30% fewer women experiencing severe perineal/vaginal trauma (RR 0.70, 95% CI 0.52 to 0.94; 5375 women; eight RCTs; low-certainty evidence). We do not know if there is a difference for blood loss at delivery (an average of 27 mL less with selective episiotomy, 95% CI from 75 mL less to 20 mL more; two trials, 336 women, very low-certainty evidence). Both selective and routine episiotomy have little or no effect on infants with Apgar score less than seven at five minutes (four trials, no events; 3908 women, moderate-certainty evidence); and there may be little or no difference in perineal infection (RR 0.90, 95% CI 0.45 to 1.82, three trials, 1467 participants, low-certainty evidence).\nFor pain, we do not know if selective episiotomy compared with routine results in fewer women with moderate or severe perineal pain (measured on a visual analogue scale) at three days postpartum (RR 0.71, 95% CI 0.48 to 1.05, one trial, 165 participants, very low-certainty evidence). There is probably little or no difference for long-term (six months or more) dyspareunia (RR1.14, 95% CI 0.84 to 1.53, three trials, 1107 participants, moderate-certainty evidence); and there may be little or no difference for long-term (six months or more) urinary incontinence (average RR 0.98, 95% CI 0.67 to 1.44, three trials, 1107 participants, low-certainty evidence). One trial reported genital prolapse at three years postpartum. There was no clear difference between the two groups (RR 0.30, 95% CI 0.06 to 1.41; 365 women; one trial, low certainty evidence). Other outcomes relating to long-term effects were not reported (urinary fistula, rectal fistula, and faecal incontinence). Subgroup analyses by parity (primiparae versus multiparae) and by surgical method (midline versus mediolateral episiotomy) did not identify any modifying effects. Pain was not well assessed, and women's preferences were not reported.\nOne trial examined selective episiotomy compared with routine episiotomy in women where an operative vaginal delivery was intended in 175 women, and did not show clear difference on severe perineal trauma between the restrictive and routine use of episiotomy, but the analysis was underpowered.\nAuthors' conclusions\nIn women where no instrumental delivery is intended, selective episiotomy policies result in fewer women with severe perineal/vaginal trauma. Other findings, both in the short or long term, provide no clear evidence that selective episiotomy policies results in harm to mother or baby.\nThe review thus demonstrates that believing that routine episiotomy reduces perineal/vaginal trauma is not justified by current evidence. Further research in women where instrumental delivery is intended may help clarify if routine episiotomy is useful in this particular group. These trials should use better, standardised outcome assessment methods.\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 prepared this edition of this review by updating the methods and searching for evidence from the medical literature on 14 September 2016. The review now includes 11 randomised controlled trials (with 5977 women) that compared episiotomy as needed (selective episiotomy) with routine episiotomy in terms of benefits and harms for mother and baby in women at low risk of instrumental delivery.\nThe trials were from ten different countries. In women where health staff were only conducting selective episiotomy, there may be 30% fewer with severe perineal trauma at birth compared with women where a policy of routine episiotomy was applied (eight trials, 5375 women, low-certainty evidence). We do not know if there is a difference in average blood loss between the groups (two trials, very low-certainty evidence). There is probably no difference in Apgar less than seven at five minutes, with no events in either groups (moderate-certainty evidence). We do not know if there is a difference in the number of women with moderate or severe perineal pain three days after giving birth (one trial, 165 women, very low-certainty evidence) but careful assessment of women's pain was not well carried out in the included trials. There may be little or no difference in the number of women developing perineal infection (two trials, low-certainty evidence); and there is probably little or no difference in women reporting painful sexual intercourse six months or more after delivery (three trials, 1107 women, moderate-certainty evidence); for urinary incontinence six months or more after delivery, there may be little or no difference between the groups. One study reported genital prolapse three years after the birth and there was no clear difference between groups (low-certainty evidence). Other important outcomes relating to long-term effects were not reported in these trials (urinary fistula, rectal fistula, and faecal incontinence).\nOne trial examined selective episiotomy compared with routine episiotomy in women for whom an operative vaginal birth was intended. The results showed no clear difference in severe perineal trauma between the restrictive and routine use of episiotomy.\nWomen's views on the different policies were not reported."
}
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query-laysum | 4600 | [
{
"role": "user",
"content": "Abstract: Background\nAllogeneic haematopoietic stem cell transplantation (SCT) is an established treatment for many malignant and non-malignant haematological disorders. Graft-versus-host disease (GVHD), a condition frequently occurring after an allogeneic SCT, is the result of host tissues being attacked by donor immune cells. It affects more than half of the patients after transplant either as acute and or chronic GVHD. One strategy for the prevention of GVHD is the administration of anti-thymocyte globulins (ATGs), a set of polyclonal antibodies directed against a variety of immune cell epitopes, leading to immunosuppression and immunomodulation.\nObjectives\nTo assess the effect of ATG used for the prevention of GVHD in patients undergoing allogeneic SCT with regard to overall survival, incidence and severity of acute and chronic GVHD, incidence of relapse, non-relapse mortality, graft failure and adverse events.\nSearch methods\nFor this update we searched the CENTRAL, MEDLINE, Embase, trial registers and conference proceedings on the 18th November 2022 along with reference checking and contacting study authors to identify additional studies.\nWe did not apply language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating the impact of ATG on GVHD prophylaxis in adults suffering from haematological diseases and undergoing allogeneic SCT. The selection criteria were modified from the previous version of this review. Paediatric studies and studies where patients aged < 18 years constituted more than 20 % of the total number were excluded. Treatment arms had to differ only in the addition of ATG to the standard GVHD prophylaxis regimen.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane Collaboration for data collection, extraction and analyses.\nMain results\nFor this update we included seven new RCTs, leading to a total of ten studies investigating 1413 participants. All patients had a haematological condition which warranted an allogeneic SCT. The risk of bias was estimated as low for seven and unclear for three studies.\nATG probably has little or no influence on overall survival (HR (hazard ratio) 0.93 (95 % confidence interval (CI) 0.77 to 1.13, nine studies, n = 1249, moderate-certainty evidence)). Estimated absolute effect: 430 surviving people per 1000 people not receiving ATG compared to 456 people surviving per 1000 people receiving the intervention (95 % CI 385 to 522 per 1000 people).\nATG results in a reduction in acute GVHD II to IV with relative risk (RR) 0.68 (95 % CI 0.60 to 0.79, 10 studies, n = 1413, high-certainty evidence). Estimated absolute effect: 418 acute GVHD II to IV per 1000 people not receiving ATG compared to 285 per 1000 people receiving the intervention (95 % CI 251 to 331 per 1000 people). Addition of ATG results in a reduction of overall chronic GvHD with a RR of 0.53 (95 % CI 0.45 to 0.61, eight studies, n = 1273, high-certainty evidence). Estimated absolute effect: 506 chronic GVHD per 1000 people not receiving ATG compared to 268 per 1000 people receiving the intervention (95 % CI 228 to 369 per 1000 people). Further data on severe acute GVHD and extensive chronic GVHD are available in the manuscript.\nATG probably slightly increases the incidence of relapse with a RR of 1.21 (95 % CI 0.99 to 1.49, eight studies, n =1315, moderate-certainty evidence).\nNon relapse mortality is probably slightly or not affected by ATG with an HR of 0.86 (95 % CI 0.67 to 1.11, nine studies, n=1370, moderate-certainty evidence).\nATG prophylaxis may result in no increase in graft failure with a RR of 1.55 (95 % CI 0.54 to 4.44, eight studies, n = 1240, low-certainty evidence).\nAdverse events could not be analysed due to the serious heterogeneity in the reporting between the studies, which limited comparability (moderate-certainty evidence) and are reported in a descriptive manner.\nSubgroup analyses on ATG types, doses and donor type are available in the manuscript.\nAuthors' conclusions\nThis systematic review suggests that the addition of ATG during allogeneic SCT probably has little or no influence on overall survival. ATG results in a reduction in the incidence and severity of acute and chronic GvHD. ATG intervention probably slightly increases the incidence of relapse and probably does not affect the non relapse mortality. Graft failure may not be affected by ATG prophylaxis. Analysis of data on adverse events was reported in a narrative manner. A limitation for the analysis was the imprecision in reporting between the studies thereby reducing the confidence in the certainty of evidence.\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"
},
{
"role": "assistant",
"content": "We have moderate confidence in our finding that ATG has little or no influence on overall survival. We have high confidence in our finding that ATG reduces acute and chronic GVHD. We have moderate confidence in our finding that ATG probably slightly increases the incidence of relapse and probably does not affect non-relapse mortality. The addition of ATG may result in no increase in graft failure, but our confidence in the finding is low. All the aforementioned limitations in the certainty of evidence are caused by serious or very serious imprecision.\nWe have moderate confidence in our analysis on adverse events, although we report in a narrative manner, due to heterogeneity in the reported outcomes."
}
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query-laysum | 4601 | [
{
"role": "user",
"content": "Abstract: Background\nIntraoperative hypothermia during both open and laparoscopic abdominal surgery may be associated with adverse events. For laparoscopic abdominal surgery, the use of heated insufflation systems for establishing pneumoperitoneum has been described to prevent hypothermia. Humidification of the insufflated gas is also possible. Past studies on heated insufflation have shown inconclusive results with regards to maintenance of core temperature and reduction of postoperative pain and recovery times.\nObjectives\nTo determine the effect of heated gas insufflation compared to cold gas insufflation on maintaining intraoperative normothermia as well as patient outcomes following laparoscopic abdominal surgery.\nSearch methods\nWe searched Cochrane Colorectal Cancer Specialised Register (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 8), Ovid MEDLINE (1950 to September 2016), Ovid Embase (1974 to September 2016), International Pharmaceutical Abstracts (IPA) (September 2016), Web of Science (1985 to September 2016), Scopus, www.clinicaltrials.gov and the National Research Register (1956 to September 2016). We also searched grey literature and cross references. Searches were limited to human studies without language restriction.\nSelection criteria\nOnly randomised controlled trials comparing heated (with or without humidification) with cold gas insufflation in adult and paediatric populations undergoing laparoscopic abdominal procedures were included. We assessed study quality in regards to relevance, design, sequence generation, allocation concealment, blinding, possibility of incomplete data and selective reporting. Two review authors independently selected studies for the review, with any disagreement resolved in consensus with a third co-author.\nData collection and analysis\nTwo review authors independently performed screening of eligible studies, data extraction and methodological quality assessment of the trials. We classified a study as low-risk of bias if all of the first six main criteria indicated in the 'Risk of Bias Assessment' table were assessed as low risk. We used data sheets to collect data from eligible studies. We presented results using mean differences for continuous outcomes and relative risks for dichotomous outcomes, with 95% confidence intervals. We used Review Manager (RevMan) 5.3 software to calculate the estimated effects. We took publication bias into consideration and compiled funnel plots.\nMain results\nWe included 22 studies in this updated analysis, including six new trials with 584 additional participants, resulting in a total of 1428 participants. The risk of bias was low in 11 studies, high in one study and unclear in the remaining studies, due primarily to failure to report methodology for randomisation, and allocation concealment or blinding, or both. Fourteen studies examined intraoperative core temperatures among heated and humidified insufflation cohorts and core temperatures were higher compared to cold gas insufflation (MD 0.31 °C, 95% CI, 0.09 to 0.53, I2 = 88%, P = 0.005) (low-quality evidence). If the analysis was limited to the eight studies at low risk of bias, this result became non-significant but remained heterogeneous (MD 0.18 °C, 95% CI, -0.04 to 0.39, I2= 81%, P = 0.10) (moderate-quality evidence).\nIn comparison to the cold CO2 group, the meta-analysis of the heated, non-humidified group also showed no statistically significant difference between groups. Core temperature was statistically, significantly higher in the heated, humidified CO2 with external warming groups (MD 0.29 °C, 95% CI, 0.05 to 0.52, I2 = 84%, P = 0.02) (moderate-quality evidence). Despite the small difference in temperature of 0.31 °C with heated CO2, this is unlikely to be of clinical significance.\nFor postoperative pain scores, there were no statistically significant differences between heated and cold CO2, either overall, or for any of the subgroups assessed. Interestingly, morphine-equivalent use was homogeneous and higher in heated, non-humidified insufflation compared to cold insufflation for postoperative day one (MD 11.93 mg, 95% CI 0.92 to 22.94, I2 = 0%, P = 0.03) (low-quality evidence) and day two (MD 9.79 mg, 95% CI 1.58 to 18.00, I2 = 0%, P = 0.02) (low-quality evidence). However, morphine use was not significantly different six hours postoperatively or in any humidified insufflation groups.\nThere was no apparent effect on length of hospitalisation, lens fogging or length of operation with heated compared to cold gas insufflation, with or without humidification. Recovery room time was shorter in the heated cohort (MD -26.79 minutes, 95% CI -51.34 to -2.25, I2 = 95%, P = 0.03) (low-quality evidence). When the one and only unclear-risk study was removed from the analysis, the difference in recovery-room time became non-significant and the studies were statistically homogeneous (MD -1.22 minutes, 95% CI, -6.62 to 4.17, I2 = 12%, P = 0.66) (moderate-quality evidence).\nThere were also no differences in the frequency of major adverse events that occurred in the cold or heated cohorts.\nThese results should be interpreted with caution due to some limitations. Heterogeneity of core temperature remained significant despite subgroup analysis, likely due to variations in the study design of the individual trials, as the trials had variations in insufflation gas temperatures (35 ºC to 37 ºC), humidity ranges (88% to 100%), gas volumes and location of the temperature probes. Additionally, some of the trials lacked specific study design information making evaluation difficult.\nAuthors' conclusions\nWhile heated, humidified gas leads to mildly smaller decreases in core body temperatures, clinically this does not account for improved patient outcomes, therefore, there is no clear evidence for the use of heated gas insufflation, with or without humidification, compared to cold gas insufflation in laparoscopic abdominal surgery.\n\nGiven the provided abstract, please respond to the following query: \"Authors' Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "While heated, humidified gas leads to slightly smaller decreases in core body temperatures, this does not account for improvement in any patient outcomes. Therefore, there is no clear evidence for the use of heated gas insufflation, with or without humidification, in laparoscopic abdominal surgery."
}
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query-laysum | 4602 | [
{
"role": "user",
"content": "Abstract: Background\nSteroids have been used widely since the early 1970s for the treatment of adult-onset minimal change disease (MCD). Recently, newer agents have been used in adult MCD aiming to reduce the risk of adverse effects. The response rates to immunosuppressive agents in adult MCD are more variable than in children. The optimal agent, dose, and duration of treatment for the first episode of nephrotic syndrome, or for disease relapse(s) have not been determined. This is an update of a review first published in 2008.\nObjectives\nWe aimed to 1) evaluate the benefits and harms of different agents, including both immunosuppressive and non-immunosuppressive agents, in adults with MCD causing the nephrotic syndrome; and 2) evaluate the efficacy of interventions on 'time-to-remission' of nephrotic syndrome, in adults with MCD causing the nephrotic syndrome.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 21 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\nRandomised controlled trials (RCTs) and quasi-RCTs of any intervention for MCD with nephrotic syndrome in adults over 18 years were included. Studies comparing different types, routes, frequencies, and duration of immunosuppressive agents and non-immunosuppressive agents were assessed.\nData collection and analysis\nTwo authors independently assessed study quality and extracted data. Statistical analyses were performed using the random-effects model and results were expressed as a risk ratio (RR) for dichotomous outcomes, or mean difference (MD) for continuous data with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFifteen RCTs (769 randomised participants) were identified; four studies evaluated different prednisolone regimens, eight studies evaluated the calcineurin inhibitors (CNIs) (tacrolimus or cyclosporin), two studies evaluated enteric-coated mycophenolate sodium (EC-MPS) and one study evaluated levamisole. In all but two studies of non-corticosteroid agents, reduced-dose prednisolone was given with the treatment agent and the comparator was high-dose prednisolone. In the risk of bias assessment, 11 and seven studies were at low risk of bias for sequence generation and allocation concealment, respectively. No studies were at low risk of performance bias and eight studies were at low risk of detection bias. Thirteen, 10 and six studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nCompared with no specific treatment, it is uncertain whether prednisolone increases the number with complete remission (1 study, 28 participants: RR 1.44, 95% CI 0.95 to 2.19), complete or partial remission (1 study, 28 participants: RR 1.38, 95% CI 0.98 to 1.95), subsequent relapse (1 study, 28 participants: RR 0.75, 95% CI 0.48 to 1.17), or reduces the adverse effects because the certainty of the evidence is very low. Compared with oral prednisolone alone, it is uncertain whether intravenous methylprednisolone and prednisolone increase the number with complete remission (2 studies, 35 participants: RR 1.76, 95% CI 0.17 to 18.32; I² = 90%), relapse (two studies, 19 participants. RR 1.18, 95% CI 0.65 to 2.15; I² = 0%) or adverse events because the certainty of the evidence is very low.\nCompared with prednisolone alone, CNIs with reduced-dose prednisolone or without prednisolone probably make little or no difference to the number achieving complete remission (8 studies; 492 participants: RR 0.99, 95% CI 0.93 to 1.05; I² = 0%), complete or partial remission (4 studies, 269 participants: RR 1.01, 95% CI 0.96 to 1.05; I² = 0%), or relapse (7 studies; 422 participants: RR 0.73, 95% CI 0.51 to 1.03; I² = 0%) (moderate certainty evidence), may reduce the risk of obesity or Cushing's Syndrome (5 studies; 388 participants: RR 0.11, 95% CI 0.02 to 0.59; I² = 45%) and the risk of acne (4 studies; 270 participants: RR 0.15, 95% CI 0.03 to 0.67; I² = 0%) (low certainty evidence); and had uncertain effects on diabetes or hyperglycaemia, hypertension, and acute kidney injury (AKI) (low certainty evidence).\nCompared with prednisolone alone, EC-MPS with reduced-dose prednisolone probably make little or no difference to the number undergoing complete remission at 4 weeks (1 study, 114 participants: RR 1.12, 95% CI 0.84 to 1.50), and at 24 weeks probably make little or no difference to the number undergoing complete remission (2 studies, 134 participants: RR 1.12, 95% CI 0.84 to 1.38; I² = 0%) (moderate certainty evidence), complete or partial remission (2 studies 134 participants: RR 0.92, 95% CI 0.75 to 1.12; I² = 0%), relapse (2 studies, 83 participants: RR 0.50, 95% CI 0.07 to 3.74; I² = 56%) (low certainty evidence); or to the adverse events of new-onset glucose intolerance, death, or AKI (low certainty evidence).\nOne study (24 participants) compared levamisole and prednisolone with prednisolone in patients with relapsing disease. The authors identified no differences in mean relapse rate or adverse effects but no standard deviations were provided.\nAuthors' conclusions\nThis updated review has identified evidence for the efficacy and adverse effects of CNIs and EC-MPS with or without reduced-dose prednisolone compared with prednisolone alone for the induction of remission in adults with MCD and nephrotic syndrome with some reductions in steroid-associated adverse events. RCT data on the efficacy and adverse effects of rituximab in adults with MCD are awaited. Further, adequately powered RCTs are required to determine the relative efficacies of CNIs and EC-MPS and to evaluate these medications in patients with relapsing or steroid-resistant disease.\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 identified all randomised controlled trials (RCTs), which investigated the treatment of adults with nephrotic syndrome due to minimal change disease. We searched for RCTs evaluating steroid therapy and those evaluating other agents with/without steroid therapy."
}
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query-laysum | 4603 | [
{
"role": "user",
"content": "Abstract: Background\nCisplatin and several related antineoplastic drugs used to treat many types of solid tumours are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.\nObjectives\nTo examine the efficacy and safety of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related drugs.\nSearch methods\nOn 4 March 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS, and CINAHL Plus for randomised trials designed to evaluate neuroprotective agents used to prevent or limit neurotoxicity of cisplatin and related drugs among human patients.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs in which the participants received chemotherapy with cisplatin or related compounds, with a potential chemoprotectant (acetylcysteine, amifostine, adrenocorticotrophic hormone (ACTH), BNP7787, calcium and magnesium (Ca/Mg), diethyldithiocarbamate (DDTC), glutathione, Org 2766, oxcarbazepine, or vitamin E) compared to placebo, no treatment, or other treatments. We considered trials in which participants underwent evaluation zero to six months after completing chemotherapy using quantitative sensory testing (the primary outcome) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary outcomes).\nData collection and analysis\nTwo review authors assessed each study, extracted the data and reached consensus, according to standard Cochrane methodology.\nMain results\nAs of 2013, the review includes 29 studies describing nine possible chemoprotective agents, as well as description of two published meta-analyses. Among these trials, there were sufficient data in some instances to combine the results from different studies, most often using data from secondary non-quantitative measures. Nine of the studies were newly included at this update. Few of the included studies were at a high risk of bias overall, although often there was too little information to make an assessment. At least two review authors performed a formal review of an additional 44 articles but we did not include them in the final review for a variety of reasons.\nOf seven eligible amifostine trials (743 participants in total), one used quantitative sensory testing (vibration perception threshold) and demonstrated a favourable outcome in terms of amifostine neuroprotection, but the vibration perception threshold result was based on data from only 14 participants receiving amifostine who completed the post-treatment evaluation and should be regarded with caution. Furthermore the change measured was subclinical. None of the three eligible Ca/Mg trials (or four trials if a single retrospective study was included) described our primary outcome measures. The four Ca/Mg trials included a total of 886 participants. Of the seven eligible glutathione trials (387 participants), one used quantitative sensory testing but reported only qualitative analyses. Four eligible Org 2766 trials (311 participants) employed quantitative sensory testing but reported disparate results; meta-analyses of three of these trials using comparable measures showed no significant vibration perception threshold neuroprotection. The remaining trial reported only descriptive analyses. Similarly, none of the three eligible vitamin E trials (246 participants) reported quantitative sensory testing. The eligible single trials involving acetylcysteine (14 participants), diethyldithiocarbamate (195 participants), oxcarbazepine (32 participants), and retinoic acid (92 participants) did not perform quantitative sensory testing. In all, this review includes data from 2906 participants. However, only seven trials reported data for the primary outcome measure of this review, (quantitative sensory testing) and only nine trials reported our objective secondary measure, nerve conduction test results. Additionally, methodological heterogeneity precluded pooling of the results in most cases. Nonetheless, a larger number of trials reported the results of secondary (non-quantitative and subjective) measures such as the National Cancer Institute Common Toxicity Criteria (NCI-CTC) for neuropathy (15 trials), and these results we pooled and reported as meta-analysis. Amifostine showed a significantly reduced risk of developing neurotoxicity NCI-CTC (or equivalent) ≥ 2 compared to placebo (RR 0.26, 95% CI 0.11 to 0.61). Glutathione was also efficacious with an RR of 0.29 (95% CI 0.10 to 0.85). In three vitamin E studies subjective measures not suitable for combination in meta analysis each favoured vitamin E. For other interventions the qualitative toxicity measures were either negative (N-acetyl cysteine, Ca/Mg, DDTC and retinoic acid) or not evaluated (oxcarbazepine and Org 2766).\nAdverse events were infrequent or not reported for most interventions. Amifostine was associated with transient hypotension in 8% to 62% of participants, retinoic acid with hypocalcaemia in 11%, and approximately 20% of participantss withdrew from treatment with DDTC because of toxicity.\nAuthors' conclusions\nAt present, the data are insufficient to conclude that any of the purported chemoprotective agents (acetylcysteine, amifostine, calcium and magnesium, diethyldithiocarbamate, glutathione, Org 2766, oxcarbazepine, retinoic acid, or vitamin E) prevent or limit the neurotoxicity of platin drugs among human patients, as determined using quantitative, objective measures of neuropathy. Amifostine, calcium and magnesium, glutathione, and vitamin E showed modest but promising (borderline statistically significant) results favouring their ability to reduce the neurotoxicity of cisplatin and related chemotherapies, as measured using secondary, non-quantitative and subjective measures such as the NCI-CTC neuropathy grading scale. Among these interventions, the efficacy of only vitamin E was evaluated using quantitative nerve conduction studies; the results were negative and did not support the positive findings based on the qualitative measures. In summary, the present studies are limited by the small number of participants receiving any particular agent, a lack of objective measures of neuropathy, and differing results among similar trials, which make it impossible to conclude that any of the neuroprotective agents tested prevent or limit the neurotoxicity of platinum drugs.\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": "Cisplatin and other related platinum-containing drugs that are used to treat solid tumours are toxic to the peripheral nervous system. Most people who complete a full course of cisplatin chemotherapy develop a sensory neuropathy (damage to nerves that carry sensation). Symptoms can include tingling in the extremities and numbness. The neuropathy may only partially recover or not recover at all when the chemotherapy is stopped. To try to reduce the toxicity of platinum drugs, researchers have looked for therapies to protect the nerves."
}
]
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query-laysum | 4604 | [
{
"role": "user",
"content": "Abstract: Background\nCentral venous catheter (CVC) placement increases the risk of thrombosis in people with cancer. Thrombosis often necessitates the removal of the CVC, resulting in treatment delays and thrombosis-related morbidity and mortality. This is an update of the Cochrane Review published in 2014.\nObjectives\nTo evaluate the efficacy and safety of anticoagulation for thromboprophylaxis in people with cancer with a CVC.\nSearch methods\nWe conducted a comprehensive literature search in May 2018 that included a major electronic search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), and Embase (Ovid); handsearching of conference proceedings; checking of references of included studies; searching for ongoing studies; and using the 'related citation' feature in PubMed. This update of the systematic review was based on the findings of a literature search conducted on 14 May 2018.\nSelection criteria\nRandomized controlled trials (RCTs) assessing the benefits and harms of unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), vitamin K antagonists (VKA), or fondaparinux or comparing the effects of two of these anticoagulants in people with cancer and a CVC.\nData collection and analysis\nUsing a standardized form, we extracted data and assessed risk of bias. Outcomes included all-cause mortality, symptomatic catheter-related venous thromboembolism (VTE), pulmonary embolism (PE), major bleeding, minor bleeding, catheter-related infection, thrombocytopenia, and health-related quality of life (HRQoL). We assessed the certainty of evidence for each outcome using the GRADE approach (Balshem 2011).\nMain results\nThirteen RCTs (23 papers) fulfilled the inclusion criteria. These trials enrolled 3420 participants. Seven RCTs compared LMWH to no LMWH (six in adults and one in children), six RCTs compared VKA to no VKA (five in adults and one in children), and three RCTs compared LMWH to VKA in adults.\nLMWH versus no LMWH\nSix RCTs (1537 participants) compared LMWH to no LMWH in adults. The meta-analyses showed that LMWH probably decreased the incidence of symptomatic catheter-related VTE up to three months of follow-up compared to no LMWH (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.22 to 0.81; risk difference (RD) 38 fewer per 1000, 95% CI 13 fewer to 52 fewer; moderate-certainty evidence). However, the analysis did not confirm or exclude a beneficial or detrimental effect of LMWH on mortality at three months of follow-up (RR 0.82, 95% CI 0.53 to 1.26; RD 14 fewer per 1000, 95% CI 36 fewer to 20 more; low-certainty evidence), major bleeding (RR 1.49, 95% CI 0.06 to 36.28; RD 0 more per 1000, 95% CI 1 fewer to 35 more; very low-certainty evidence), minor bleeding (RR 1.35, 95% CI 0.62 to 2.92; RD 14 more per 1000, 95% CI 16 fewer to 79 more; low-certainty evidence), and thrombocytopenia (RR 1.03, 95% CI 0.80 to 1.33; RD 5 more per 1000, 95% CI 35 fewer to 58 more; low-certainty evidence).\nVKA versus no VKA\nFive RCTs (1599 participants) compared low-dose VKA to no VKA in adults. The meta-analyses did not confirm or exclude a beneficial or detrimental effect of low-dose VKA compared to no VKA on mortality (RR 0.99, 95% CI 0.64 to 1.55; RD 1 fewer per 1000, 95% CI 34 fewer to 52 more; low-certainty evidence), symptomatic catheter-related VTE (RR 0.61, 95% CI 0.23 to 1.64; RD 31 fewer per 1000, 95% CI 62 fewer to 51 more; low-certainty evidence), major bleeding (RR 7.14, 95% CI 0.88 to 57.78; RD 12 more per 1000, 95% CI 0 fewer to 110 more; low-certainty evidence), minor bleeding (RR 0.69, 95% CI 0.38 to 1.26; RD 15 fewer per 1000, 95% CI 30 fewer to 13 more; low-certainty evidence), premature catheter removal (RR 0.82, 95% CI 0.30 to 2.24; RD 29 fewer per 1000, 95% CI 114 fewer to 202 more; low-certainty evidence), and catheter-related infection (RR 1.17, 95% CI 0.74 to 1.85; RD 71 more per 1000, 95% CI 109 fewer to 356; low-certainty evidence).\nLMWH versus VKA\nThree RCTs (641 participants) compared LMWH to VKA in adults. The available evidence did not confirm or exclude a beneficial or detrimental effect of LMWH relative to VKA on mortality (RR 0.94, 95% CI 0.56 to 1.59; RD 6 fewer per 1000, 95% CI 41 fewer to 56 more; low-certainty evidence), symptomatic catheter-related VTE (RR 1.83, 95% CI 0.44 to 7.61; RD 15 more per 1000, 95% CI 10 fewer to 122 more; very low-certainty evidence), PE (RR 1.70, 95% CI 0.74 to 3.92; RD 35 more per 1000, 95% CI 13 fewer to 144 more; low-certainty evidence), major bleeding (RR 3.11, 95% CI 0.13 to 73.11; RD 2 more per 1000, 95% CI 1 fewer to 72 more; very low-certainty evidence), or minor bleeding (RR 0.95, 95% CI 0.20 to 4.61; RD 1 fewer per 1000, 95% CI 21 fewer to 95 more; very low-certainty evidence). The meta-analyses showed that LMWH probably increased the risk of thrombocytopenia compared to VKA at three months of follow-up (RR 1.69, 95% CI 1.20 to 2.39; RD 149 more per 1000, 95% CI 43 fewer to 300 more; moderate-certainty evidence).\nAuthors' conclusions\nThe evidence was not conclusive for the effect of LMWH on mortality, the effect of VKA on mortality and catheter-related VTE, and the effect of LMWH compared to VKA on mortality and catheter-related VTE. We found moderate-certainty evidence that LMWH reduces catheter-related VTE compared to no LMWH. People with cancer with CVCs considering anticoagulation should balance the possible benefit of reduced thromboembolic complications with the possible harms and burden of anticoagulants.\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 the scientific literature for studies of anticoagulants in people with cancer and a CVC. The evidence is current to 14 May 2018."
}
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query-laysum | 4605 | [
{
"role": "user",
"content": "Abstract: Background\nMedications licensed for the treatment of dementia have limited efficacy against cognitive impairment or against the distressed behaviours (behavioural and psychological symptoms, or behaviour that challenges) which are also often the most distressing aspect of the disorder for caregivers. Complementary therapies, including aromatherapy, are attractive to patients, practitioners and families, because they are perceived as being unlikely to cause adverse effects. Therefore there is interest in whether aromatherapy might offer a safe means of alleviating distressed behaviours in dementia.\nObjectives\nTo assess the efficacy and safety of aromatherapy for people with dementia.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 5 May 2020 using the terms: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils. In addition, we searched MEDLINE, Embase, PsycINFO (all via Ovid SP), Web of Science Core Collection (via Thompson Web of Science), LILACS (via BIREME), CENTRAL (via the Cochrane Library), ClinicalTrials.gov and the World Health Organization (WHO) trials portal (ICTRP) on 5 May 2020.\nSelection criteria\nWe included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.\nData collection and analysis\nTwo reviewers independently selected studies for inclusion, extracted data and assessed risk of bias in included studies, involving other authors to reach consensus decisions where necessary. We did not perform any meta-analyses because of heterogeneity between studies, but presented a narrative synthesis of results from the included trials. Because of the heterogeneity of analysis methods and inadequate or absent reporting of data from some trials, we used statistical significance (P ≤ or > 0.5) as a summary metric when synthesising results across studies. As far as possible, we used GRADE methods to assess our confidence in the results of the trials, downgrading for risk of bias and imprecision.\nMain results\nWe included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were lavender (eight studies); lemon balm (four studies); lavender and lemon balm, lavender and orange, and cedar extracts (one study each). For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66), reducing our confidence in the results. Our primary outcomes were agitation, overall behavioural and psychological symptoms, and adverse effects. Ten trials assessed agitation using various scales. Among the five trials for which our confidence in the results was moderate or low, four trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other five trials either reported no useable data or our confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and we had moderate or low confidence in the results of five of them. Of these, four reported significant benefit from aromatherapy and one reported no significant effect. Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. We did not find evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. Our confidence in the results of these studies was low.\nAuthors' conclusions\nWe have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.\n\nGiven the provided abstract, please respond to the following query: \"What we did\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature up to 5 May 2020, looking for studies which compared aromatherapy for people with dementia to a control treatment, which could be either usual care or ‘dummy’ aromatherapy involving a non-fragrant oil. To make the comparison fair, the studies had to assign people randomly to aromatherapy or to the control treatment. We looked at the effect on agitation, behavioural and mental health issues, and other important symptoms of dementia. We also looked for reports of side effects. Because the studies were so different from each other, we were not able to combine results statistically so we described the results of individual studies and assessed how confident we could be in them."
}
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query-laysum | 4606 | [
{
"role": "user",
"content": "Abstract: Background\nObservational studies have shown differences in process and outcome between the consultations of primary care physicians whose average consultation lengths differ. These differences may be due to self selection. This is the first update of the original review.\nObjectives\nTo assess the effects of interventions to alter the length of primary care physicians' consultations.\nSearch methods\nWe searched the following electronic databases until 4 January 2016: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP).\nSelection criteria\nRandomised controlled trials and non-randomised controlled trials of interventions to alter the length of primary care physicians' consultations.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of included studies using agreed criteria and resolved disagreements by discussion. We attempted to contact authors of primary studies with missing data. Given the heterogeneity of studies, we did not conduct a meta-analysis. We assessed the certainty of the evidence for the most important outcomes using the GRADE approach and have presented the results in a narrative summary.\nMain results\nFive studies met the inclusion criteria. All were conducted in the UK, and tested short-term changes in the consultation time allocated to each patient. Overall, our confidence in the results was very low; most studies had a high risk of bias, particularly due to non-random allocation of participants and the absence of data on participants' characteristics and small sample sizes. We are uncertain whether altering appointment length increases primary care consultation length, number of referrals and investigations, prescriptions, or patient satisfaction based on very low-certainty evidence. None of the studies reported on the effects of altering the length of consultation on resources used.\nAuthors' conclusions\nWe did not find sufficient evidence to support or refute a policy of altering the lengths of primary care physicians' consultations. It is possible that these findings may change if high-quality trials are reported in the future. Further trials are needed that focus on health outcomes and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently not enough evidence to say whether altering the amount of time that doctors consult with patients provides benefits or not."
}
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query-laysum | 4607 | [
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic immune-mediated condition of transmural inflammation in the gastrointestinal tract, associated with significant morbidity and decreased quality of life. The endocannabinoid system provides a potential therapeutic target for cannabis and cannabinoids and animal models have shown benefit in decreasing inflammation. However, there is also evidence to suggest transient adverse events such as weakness, dizziness and diarrhea, and an increased risk of surgery in people with CD who use cannabis.\nObjectives\nThe objectives were to assess the efficacy and safety of cannabis and cannabinoids for induction and maintenance of remission in people with CD.\nSearch methods\nWe searched MEDLINE, Embase, AMED, PsychINFO, the Cochrane IBD Group Specialized Register, CENTRAL, ClinicalTrials.Gov, and the European Clinical Trials Register up to 17 October 2018. We searched conference abstracts, references and we also contacted researchers in this field for upcoming publications.\nSelection criteria\nRandomized controlled trials comparing any form of cannabis or its cannabinoid derivatives (natural or synthetic) to placebo or an active therapy for adults with Crohn’s disease were included.\nData collection and analysis\nTwo authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. The primary outcomes were clinical remission and relapse. Remission is commonly defined as a Crohn's disease activity index (CDAI) of < 150. Relapse is defined as a CDAI > 150. Secondary outcomes included clinical response, endoscopic remission, endoscopic improvement, histological improvement, quality of life, C-reactive protein (CRP) and fecal calprotectin measurements, adverse events (AEs), serious AEs, withdrawal due to AEs, and cannabis dependence and withdrawal effects. We calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) and 95% CI. Data were combined for analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). Data were analyzed on an intention-to-treat basis and the overall certainty of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nThree studies (93 participants) that assessed cannabis in people with active CD met the inclusion criteria. One ongoing study was also identified. Participants in two of the studies were adults with active Crohn's disease who had failed at least one medical treatment. The inclusion criteria for the third study were unclear. No studies that assessed cannabis therapy in quiescent CD were identified. The studies were not pooled due to differences in the interventional drug.\nOne small study (N = 21) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active CD. This study was rated as high risk of bias for blinding and other bias (cannabis participants were older than placebo). The effects of cannabis on clinical remission were unclear. Forty-five per cent (5/11) of the cannabis group achieved clinical remission compared with 10% (1/10) of the placebo group (RR 4.55, 95% CI 0.63 to 32.56; very low certainty evidence). A difference was observed in clinical response (decrease in CDAI score of >100 points) rates. Ninety-one per cent (10/11) of the cannabis group achieved a clinical response compared to 40% (4/10) of the placebo group (RR 2.27, 95% CI 1.04 to 4.97; very low certainty evidence). More AEs were observed in the cannabis cigarette group compared to placebo (RR 4.09, 95% CI 1.15 to 14.57; very low certainty evidence). These AEs were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. This study did not report on serious AEs or withdrawal due to AEs.\nOne small study (N = 22) compared cannabis oil (5% cannabidiol) to placebo oil in people with active CD. This study was rated as high risk of bias for other bias (cannabis participants were more likely than placebo participants to be smokers). There was no difference in clinical remission rates. Forty per cent (4/10) of cannabis oil participants achieved remission at 8 weeks compared to 33% (3/9) of the placebo participants (RR 1.20, 95% CI 0.36 to 3.97; very low certainty evidence). There was no difference in the proportion of participants who had a serious adverse event. Ten per cent (1/10) of participants in the cannabis oil group had a serious adverse event compared to 11% (1/9) of placebo participants (RR 0.90, 95% CI 0.07 to 12.38, very low certainty evidence). Both serious AEs were worsening Crohn's disease that required rescue intervention. This study did not report on clinical response, CRP, quality of life or withdrawal due to AEs.\nOne small study (N= 50) compared cannabis oil (15% cannabidiol and 4% THC) to placebo in participants with active CD. This study was rated as low risk of bias. Differences in CDAI and quality of life scores measured by the SF-36 instrument were observed. The mean quality of life score after 8 weeks of treatment was 96.3 in the cannabis oil group compared to 79.9 in the placebo group (MD 16.40, 95% CI 5.72 to 27.08, low certainty evidence). After 8 weeks of treatment, the mean CDAI score was118.6 in the cannabis oil group compared to 212.6 in the placebo group (MD -94.00, 95%CI -148.86 to -39.14, low certainty evidence). This study did not report on clinical remission, clinical response, CRP or AEs.\nAuthors' conclusions\nThe effects of cannabis and cannabis oil on Crohn's disease are uncertain. Thus no firm conclusions regarding the efficacy and safety of cannabis and cannabis oil in adults with active Crohn's disease can be drawn. The effects of cannabis or cannabis oil in quiescent Crohn's disease have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and quiescent Crohn's disease. Different doses of cannabis and delivery modalities should be investigated.\n\nGiven the provided abstract, please respond to the following query: \"What is Crohn's disease?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Crohn’s disease is a long-term condition that results in inflammation of the gastrointestinal tract, occurring anywhere from the mouth to the anus. Common symptoms include fever, diarrhoea, abdominal pain and weight loss. Crohn's disease is characterized by periods of relapse when people are actively experiencing symptoms and periods of remission when the symptoms stop."
}
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query-laysum | 4608 | [
{
"role": "user",
"content": "Abstract: Background\nVentilator-associated pneumonia (VAP) is defined as pneumonia developing in people who have received mechanical ventilation for at least 48 hours. VAP is a potentially serious complication in these patients who are already critically ill. Oral hygiene care (OHC), using either a mouthrinse, gel, swab, toothbrush, or combination, together with suction of secretions, may reduce the risk of VAP in these patients.\nObjectives\nTo assess the effects of oral hygiene care (OHC) on incidence of ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation in hospital intensive care units (ICUs).\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 25 February 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 1), MEDLINE Ovid (1946 to 25 February 2020), Embase Ovid (1980 to 25 February 2020), LILACS BIREME Virtual Health Library (1982 to 25 February 2020) and CINAHL EBSCO (1937 to 25 February 2020). We also searched the VIP Database (January 2012 to 8 March 2020). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched 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 (RCTs) evaluating the effects of OHC (mouthrinse, gel, swab, toothbrush or combination) in critically ill patients receiving mechanical ventilation for at least 48 hours.\nData collection and analysis\nAt least two review authors independently assessed search results, extracted data and assessed risk of bias in included studies. We contacted study authors for additional information. We reported risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, using the random-effects model of meta-analysis when data from four or more trials were combined.\nMain results\nWe included 40 RCTs (5675 participants), which were conducted in various countries including China, USA, Brazil and Iran. We categorised these RCTs into five main comparisons: chlorhexidine (CHX) mouthrinse or gel versus placebo/usual care; CHX mouthrinse versus other oral care agents; toothbrushing (± antiseptics) versus no toothbrushing (± antiseptics); powered versus manual toothbrushing; and comparisons of other oral care agents used in OHC (other oral care agents versus placebo/usual care, or head-to-head comparisons between other oral care agents). We assessed the overall risk of bias as high in 31 trials and low in two, with the rest being unclear.\nModerate-certainty evidence from 13 RCTs (1206 participants, 92% adults) shows that CHX mouthrinse or gel, as part of OHC, probably reduces the incidence of VAP compared to placebo or usual care from 26% to about 18% (RR 0.67, 95% confidence intervals (CI) 0.47 to 0.97; P = 0.03; I2 = 66%). This is equivalent to a number needed to treat for an additional beneficial outcome (NNTB) of 12 (95% CI 7 to 128), i.e. providing OHC including CHX for 12 ventilated patients in intensive care would prevent one patient developing VAP. There was no evidence of a difference between interventions for the outcomes of mortality (RR 1.03, 95% CI 0.80 to 1.33; P = 0.86, I2 = 0%; 9 RCTs, 944 participants; moderate-certainty evidence), duration of mechanical ventilation (MD -1.10 days, 95% CI -3.20 to 1.00 days; P = 0.30, I2 = 74%; 4 RCTs, 594 participants; very low-certainty evidence) or duration of intensive care unit (ICU) stay (MD -0.89 days, 95% CI -3.59 to 1.82 days; P = 0.52, I2 = 69%; 5 RCTs, 627 participants; low-certainty evidence). Most studies did not mention adverse effects. One study reported adverse effects, which were mild, with similar frequency in CHX and control groups and one study reported there were no adverse effects.\nToothbrushing (± antiseptics) may reduce the incidence of VAP (RR 0.61, 95% CI 0.41 to 0.91; P = 0.01, I2 = 40%; 5 RCTs, 910 participants; low-certainty evidence) compared to OHC without toothbrushing (± antiseptics). There is also some evidence that toothbrushing may reduce the duration of ICU stay (MD -1.89 days, 95% CI -3.52 to -0.27 days; P = 0.02, I2 = 0%; 3 RCTs, 749 participants), but this is very low certainty. Low-certainty evidence did not show a reduction in mortality (RR 0.84, 95% CI 0.67 to 1.05; P = 0.12, I2 = 0%; 5 RCTs, 910 participants) or duration of mechanical ventilation (MD -0.43, 95% CI -1.17 to 0.30; P = 0.25, I2 = 46%; 4 RCTs, 810 participants).\nAuthors' conclusions\nChlorhexidine mouthwash or gel, as part of OHC, probably reduces the incidence of developing ventilator-associated pneumonia (VAP) in critically ill patients from 26% to about 18%, when compared to placebo or usual care. We did not find a difference in mortality, duration of mechanical ventilation or duration of stay in the intensive care unit, although the evidence was low certainty. OHC including both antiseptics and toothbrushing may be more effective than OHC with antiseptics alone to reduce the incidence of VAP and the length of ICU stay, but, again, the evidence is low certainty. There is insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with adverse effects.\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"
},
{
"role": "assistant",
"content": "The evidence in this Cochrane Review is current to February 2020."
}
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query-laysum | 4609 | [
{
"role": "user",
"content": "Abstract: Background\nThere has been extensive debate in the surgical literature regarding the optimum surgical access approach to the infrarenal abdominal aorta during an operation to repair an abdominal aortic aneurysm. The published trials comparing retroperitoneal (RP) and transperitoneal (TP) aortic surgery show conflicting results. This is an update of the review first published in 2016.\nObjectives\nTo assess the effectiveness and safety of the retroperitoneal versus transperitoneal approach for elective open abdominal aortic aneurysm repair on mortality, complications, hospital stay and blood loss.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 30 November 2020. The review authors searched the Chinese Biomedical Literature Database and handsearched reference lists of relevant articles to identify additional trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that assessed the RP approach versus the TP approach for elective open abdominal aortic aneurysm (AAA) repair. There were no restrictions on language or publication status.\nData collection and analysis\nTwo review authors independently extracted data from the included trials. We resolved any disagreements through discussion with a third review author. Two review authors independently assessed the risk of bias in included trials with the Cochrane risk of bias tool. For dichotomous outcomes, we calculated the odds ratio (OR) with the corresponding 95% confidence interval (CI). For continuous data, we calculated a pooled estimate of treatment effect by calculating the mean difference (MD) and standard deviation (SD) with corresponding 95% CIs. We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. We used GRADE to assess the overall certainty of the evidence. We evaluated the outcomes of mortality, complications, intensive care unit (ICU) stay, hospital stay, blood loss, aortic cross-clamp time and operating time.\nMain results\nWe identified no new studies from the updated searches. After reassessment, we included one study which had previously been excluded. Five RCTs with a combined total of 152 participants are included. The overall certainty of the evidence ranged from low to very low because of the low methodological quality of the included trials (unclear random sequence generation method and allocation concealment, and no blinding of outcome assessors), small sample sizes, small number of events, high heterogeneity and inconsistency between the included trials, no power calculations and relatively short follow-up.\nThere was no evidence of a difference between the RP approach and the TP approach regarding mortality (odds ratio (OR) 0.32, 95% CI 0.01 to 8.25; 3 studies, 110 participants; very low-certainty evidence). Similarly, there was no evidence of a difference in complications such as hematoma (OR 0.90, 95% CI 0.13 to 6.48; 2 studies, 75 participants; very low-certainty evidence), abdominal wall hernia (OR 10.76, 95% CI 0.55 to 211.78; 1 study, 48 participants; very low-certainty evidence), or chronic wound pain (OR 2.20, 95% CI 0.36 to 13.34; 1 study, 48 participants; very low-certainty evidence) between the RP and TP approaches in participants undergoing elective open AAA repair. The RP approach may reduce ICU stay (mean difference (MD) -19.02 hours, 95% CI -30.83 to -7.21; 3 studies, 106 participants; low-certainty evidence); hospital stay (MD -3.30 days, 95% CI -4.85 to-1.75; 5 studies, 152 participants; low-certainty evidence); and blood loss (MD -504.87 mL, 95% CI -779.19 to -230.56; 4 studies, 129 participants; very low-certainty evidence). There was no evidence of a difference between the RP approach and the TP approach regarding aortic cross-clamp time (MD 0.69 min, 95% CI -7.23 to 8.60; 4 studies, 129 participants; very low-certainty evidence) or operating time (MD -15.94 min, 95% CI -34.76 to 2.88; 4 studies, 129 participants; very low-certainty evidence).\nAuthors' conclusions\nVery low-certainty evidence from five small RCTs showed no clear evidence of a difference between the RP approach and the TP approach for elective open AAA repair in terms of mortality, or for rates of complications including hematoma (very low-certainty evidence), abdominal wall hernia (very low-certainty evidence), or chronic wound pain (very low-certainty evidence). However, a shorter intensive care unit (ICU) stay and shorter hospital stay was probably indicated following the RP approach compared to the TP approach (both low-certainty evidence). A possible reduction in blood loss was also shown after the RP approach (very low-certainty evidence). There is no clear difference between the RP approach and TP approach in aortic cross-clamp time or operating time. Further well-designed, large-scale RCTs assessing the RP approach versus TP approach for elective open AAA repair are required.\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 new studies from the updated searches. After reassessment, we included one study which had previously been excluded. Therefore, the review includes five small randomized controlled trials (RCTs), including 152 participants. The evidence in this Cochrane Review is current to 30 November 2020. There were no clear differences between RP and TP for the outcome of death. Similarly, there was no clear evidence that RP might increase complications such as hematoma (swelling of clotted blood), chronic wound pain and abdominal wall hernia compared with TP, but there were variations between the included trials. We found that RP might result in shorter hospital stay and intensive care unit (ICU) stay and less blood loss compared with TP. There were no clear differences between the two approaches for operating time and aortic cross-clamp time (length of time that a surgical instrument, used to clamp the aorta and separate the circulation from the outflow of the heart, is used)."
}
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query-laysum | 4610 | [
{
"role": "user",
"content": "Abstract: Background\nA key function of health systems is implementing interventions to improve health, but coverage of essential health interventions remains low in low-income countries. Implementing interventions can be challenging, particularly if it entails complex changes in clinical routines; in collaborative patterns among different healthcare providers and disciplines; in the behaviour of providers, patients or other stakeholders; or in the organisation of care. Decision-makers may use a range of strategies to implement health interventions, and these choices should be based on evidence of the strategies' effectiveness.\nObjectives\nTo provide an overview of the available evidence from up-to-date systematic reviews about the effects of implementation strategies for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on alternative implementation strategies and informing refinements of the framework for implementation strategies presented in the overview.\nMethods\nWe searched Health Systems Evidence in November 2010 and PDQ-Evidence up to December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of implementation strategies on professional practice and patient outcomes and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the review findings. Two overview authors independently screened reviews, extracted data and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence) and assessments of the relevance of findings to low-income countries.\nMain results\nWe identified 7272 systematic reviews and included 39 of them in this overview. An additional four reviews provided supplementary information. Of the 39 reviews, 32 had only minor limitations and 7 had important methodological limitations. Most studies in the reviews were from high-income countries. There were no studies from low-income countries in eight reviews.\nImplementation strategies addressed in the reviews were grouped into four categories – strategies targeting:\n1. healthcare organisations (e.g. strategies to change organisational culture; 1 review);\n2. healthcare workers by type of intervention (e.g. printed educational materials; 14 reviews);\n3. healthcare workers to address a specific problem (e.g. unnecessary antibiotic prescription; 9 reviews);\n4. healthcare recipients (e.g. medication adherence; 15 reviews).\nOverall, we found the following interventions to have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects.\n1.Strategies targeted at healthcare workers: educational meetings, nutrition training of health workers, educational outreach, practice facilitation, local opinion leaders, audit and feedback, and tailored interventions.\n2.Strategies targeted at healthcare workers for specific types of problems: training healthcare workers to be more patient-centred in clinical consultations, use of birth kits, strategies such as clinician education and patient education to reduce antibiotic prescribing in ambulatory care settings, and in-service neonatal emergency care training.\n3. Strategies targeted at healthcare recipients: mass media interventions to increase uptake of HIV testing; intensive self-management and adherence, intensive disease management programmes to improve health literacy; behavioural interventions and mobile phone text messages for adherence to antiretroviral therapy; a one time incentive to start or continue tuberculosis prophylaxis; default reminders for patients being treated for active tuberculosis; use of sectioned polythene bags for adherence to malaria medication; community-based health education, and reminders and recall strategies to increase vaccination uptake; interventions to increase uptake of cervical screening (invitations, education, counselling, access to health promotion nurse and intensive recruitment); health insurance information and application support.\nAuthors' conclusions\nReliable systematic reviews have evaluated a wide range of strategies for implementing evidence-based interventions in low-income countries. Most of the available evidence is focused on strategies targeted at healthcare workers and healthcare recipients and relates to process-based outcomes. Evidence of the effects of strategies targeting healthcare organisations is scarce.\n\nGiven the provided abstract, please respond to the following query: \"Strategies targeted at healthcare workers\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "- Educational meetings.\n- Nutrition training of health workers.\n- Educational outreach (vs. no intervention).\n- Practice facilitation.\n- Local opinion leaders.\n- Audit and feedback.\n- Tailored interventions (vs. no intervention)."
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query-laysum | 4611 | [
{
"role": "user",
"content": "Abstract: Background\nLiver transplantation is the only chance of cure for people with end-stage liver disease and some people with advanced liver cancers or acute liver failure. The increasing prevalence of these conditions drives demand and necessitates the increasing use of donated livers which have traditionally been considered suboptimal. Several novel machine perfusion preservation technologies have been developed, which attempt to ameliorate some of the deleterious effects of ischaemia reperfusion injury. Machine perfusion technology aims to improve organ quality, thereby improving outcomes in recipients of suboptimal livers when compared to traditional static cold storage (SCS; ice box).\nObjectives\nTo evaluate the effects of different methods of machine perfusion (including hypothermic oxygenated machine perfusion (HOPE), normothermic machine perfusion (NMP), controlled oxygenated rewarming, and normothermic regional perfusion) versus each other or versus static cold storage (SCS) in people undergoing liver transplantation.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 10 January 2023.\nSelection criteria\nWe included randomised clinical trials which compared different methods of machine perfusion, either with each other or with SCS. Studies comparing HOPE via both hepatic artery and portal vein, or via portal vein only, were grouped. The protocol detailed that we also planned to include quasi-randomised studies to assess treatment harms.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. overall participant survival, 2. quality of life, and 3. serious adverse events. Secondary outcomes were 4. graft survival, 5. ischaemic biliary complications, 6. primary non-function of the graft, 7. early allograft function, 8. non-serious adverse events, 9. transplant utilisation, and 10. transaminase release during the first week post-transplant. We assessed bias using Cochrane's RoB 2 tool and used GRADE to assess certainty of evidence.\nMain results\nWe included seven randomised trials (1024 transplant recipients from 1301 randomised/included livers). All trials were parallel two-group trials; four compared HOPE versus SCS, and three compared NMP versus SCS. No trials used normothermic regional perfusion.\nWhen compared with SCS, it was uncertain whether overall participant survival was improved with either HOPE (hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.42 to 1.98; P = 0.81, I2 = 0%; 4 trials, 482 recipients; low-certainty evidence due to imprecision because of low number of events) or NMP (HR 1.08, 95% CI 0.31 to 3.80; P = 0.90; 1 trial, 222 recipients; very low-certainty evidence due to imprecision and risk of bias).\nNo trials reported quality of life.\nWhen compared with SCS alone, HOPE was associated with improvement in the following clinically relevant outcomes: graft survival (HR 0.45, 95% CI 0.23 to 0.87; P = 0.02, I2 = 0%; 4 trials, 482 recipients; high-certainty evidence), serious adverse events in extended criteria DBD liver transplants (OR 0.45, 95% CI 0.22 to 0.91; P = 0.03, I2 = 0%; 2 trials, 156 participants; moderate-certainty evidence) and clinically significant ischaemic cholangiopathy in recipients of DCD livers (OR 0.31, 95% CI 0.11 to 0.92; P = 0.03; 1 trial, 156 recipients; high-certainty evidence). In contrast, NMP was not associated with improvement in any of these clinically relevant outcomes. NMP was associated with improved utilisation compared with SCS (one trial found a 50% lower rate of organ discard; P = 0.008), but the reasons underlying this effect are unknown.\nWe identified 11 ongoing studies investigating machine perfusion technologies.\nAuthors' conclusions\nIn situations where the decision has been made to transplant a liver donated after circulatory death or donated following brain death, end-ischaemic HOPE will provide superior clinically relevant outcomes compared with SCS alone. Specifically, graft survival is improved (high-certainty evidence), serious adverse events are reduced (moderate-certainty evidence), and in donors after circulatory death, clinically relevant ischaemic biliary complications are reduced (high-certainty evidence). There is no good evidence that NMP has the same benefits over SCS in terms of these clinically relevant outcomes. NMP does appear to improve utilisation of grafts that would otherwise be discarded with SCS; however, the reasons for this, and whether this effect is specific to NMP, is not clear. Further studies into NMP viability criteria and utilisation, as well as head-to-head trials with other perfusion technologies are needed.\nIn the setting of donation following circulatory death transplantation, further trials are needed to assess the effect of these ex situ machine perfusion methods against, or in combination with, normothermic regional perfusion.\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": "We found a limited number of trials and some were of mixed quality. The reported data were also insufficient for all planned analyses. None of the trials looked at a machine perfusion technique which is applied in the donor before the organs are removed (termed normothermic regional perfusion)."
}
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query-laysum | 4612 | [
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is a major public health issue with rates increasing globally. Gestational diabetes, glucose intolerance first recognised during pregnancy, usually resolves after birth and is associated with short- and long-term complications for the mother and her infant. Treatment options can include oral anti-diabetic pharmacological therapies.\nObjectives\nTo evaluate the effects of oral anti-diabetic pharmacological therapies for treating women with GDM.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (14 May 2016), ClinicalTrials.gov, WHO ICTRP (14 May 2016) and reference lists of retrieved studies.\nSelection criteria\nWe included published and unpublished randomised controlled trials assessing the effects of oral anti-diabetic pharmacological therapies for treating pregnant women with GDM. We included studies comparing oral anti-diabetic pharmacological therapies with 1) placebo/standard care, 2) another oral anti-diabetic pharmacological therapy, 3) combined oral anti-diabetic pharmacological therapies. Trials using insulin as the comparator were excluded as they are the subject of a separate Cochrane systematic review.\nWomen with pre-existing type 1 or type 2 diabetes were excluded.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted data and data were checked for accuracy.\nMain results\nWe included 11 studies (19 publications) (1487 women and their babies). Eight studies had data that could be included in meta-analyses. Studies were conducted in Brazil, India, Israel, UK, South Africa and USA. The studies varied in diagnostic criteria and treatment targets for glycaemic control for GDM. The overall risk of bias was 'unclear' due to inadequate reporting of methodology. Using GRADE the quality of the evidence ranged from moderate to very low quality. Evidence was downgraded for risk of bias (reporting bias, lack of blinding), inconsistency, indirectness, imprecision and for oral anti-diabetic therapy versus placebo for generalisability.\nOral anti-diabetic pharmacological therapies versus placebo/standard care\nThere was no evidence of a difference between glibenclamide and placebo groups for hypertensive disorders of pregnancy (risk ratio (RR) 1.24, 95% confidence interval (CI) 0.81 to 1.90; one study, 375 women, very low-quality evidence), birth by caesarean section (RR 1.03, 95% CI 0.79 to 1.34; one study, 375 women, very low-quality evidence), perineal trauma (RR 0.98, 95% CI 0.06 to 15.62; one study, 375 women, very low-quality evidence) or induction of labour (RR 1.18, 95% CI 0.79 to 1.76; one study, 375 women; very low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant, there was no evidence of a difference in the risk of being born large-for-gestational age (LGA) between infants whose mothers had been treated with glibenclamide and those in the placebo group (RR 0.89, 95% CI 0.51 to 1.58; one study, 375, low-quality evidence). No data were reported for other infant primary or GRADE outcomes (perinatal mortality, death or serious morbidity composite, neurosensory disability in later childhood, neonatal hypoglycaemia, adiposity, diabetes).\nMetformin versus glibenclamide\nThere was no evidence of a difference between metformin- and glibenclamide-treated groups for the risk of hypertensive disorders of pregnancy (RR 0.70, 95% CI 0.38 to 1.30; three studies, 508 women, moderate-quality evidence), birth by caesarean section (average RR 1.20, 95% CI 1.20; 95% CI 0.83 to 1.72, four studies, 554 women, I2 = 61%, Tau2 = 0.07 low-quality evidence), induction of labour (0.81, 95% CI 0.61 to 1.07; one study, 159 women; low-quality evidence) or perineal trauma (RR 1.67, 95% CI 0.22 to 12.52; two studies, 158 women; low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant there was no evidence of a difference between the metformin- and glibenclamide-exposed groups for the risk of being born LGA (average RR 0.67, 95% CI 0.24 to 1.83; two studies, 246 infants, I2 = 54%, Tau2 = 0.30 low-quality evidence). Metformin was associated with a decrease in a death or serious morbidity composite (RR 0.54, 95% CI 0.31 to 0.94; one study, 159 infants, low-quality evidence). There was no clear difference between groups for neonatal hypoglycaemia (RR 0.86, 95% CI 0.42 to 1.77; four studies, 554 infants, low-quality evidence) or perinatal mortality (RR 0.92, 95% CI 0.06 to 14.55, two studies, 359 infants). No data were reported for neurosensory disability in later childhood or for adiposity or diabetes.\nGlibenclamide versus acarbose\nThere was no evidence of a difference between glibenclamide and acarbose from one study (43 women) for any of their maternal or infant primary outcomes (caesarean section, RR 0.95, 95% CI 0.53 to 1.70; low-quality evidence; perinatal mortality - no events; low-quality evidence; LGA , RR 2.38, 95% CI 0.54 to 10.46; low-quality evidence). There was no evidence of a difference between glibenclamide and acarbose for neonatal hypoglycaemia (RR 6.33, 95% CI 0.87 to 46.32; low-quality evidence). There were no data reported for other pre-specified GRADE or primary maternal outcomes (hypertensive disorders of pregnancy, development of type 2 diabetes, perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour) or neonatal outcomes (death or serious morbidity composite, adiposity or diabetes).\nAuthors' conclusions\nThere were insufficient data comparing oral anti-diabetic pharmacological therapies with placebo/standard care (lifestyle advice) to inform clinical practice. There was insufficient high-quality evidence to be able to draw any meaningful conclusions as to the benefits of one oral anti-diabetic pharmacological therapy over another due to limited reporting of data for the primary and secondary outcomes in this review. Short- and long-term clinical outcomes for this review were inadequately reported or not reported. Current choice of oral anti-diabetic pharmacological therapy appears to be based on clinical preference, availability and national clinical practice guidelines.\nThe benefits and potential harms of one oral anti-diabetic pharmacological therapy compared with another, or compared with placebo/standard care remains unclear and requires further research. Future trials should attempt to report on the core outcomes suggested in this review, in particular long-term outcomes for the woman and the infant that have been poorly reported to date, women's experiences and cost benefit.\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": "Women diagnosed with GDM are at a greater risk of experiencing complications such as high blood pressure during pregnancy and at birth. They have an increased risk of developing diabetes later in life. The babies of women who have been diagnosed with GDM can be larger than normal and this can cause injuries to the mother and the baby at birth. The birth is more likely to be induced or the baby born by caesarean section. These babies are at risk of developing diabetes as children or young adults. Finding the best medications to treat the women and prevent the complications that are linked to GDM is therefore important."
}
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query-laysum | 4613 | [
{
"role": "user",
"content": "Abstract: Background\nAmyotrophic lateral sclerosis (ALS), which is also known as motor neuron disease (MND), is a fatal disease associated with rapidly progressive disability, for which no definitive treatment exists. Current treatment approaches largely focus on relieving symptoms to improve the quality of life of those affected. The therapeutic potential of cell-based therapies in ALS/MND has not been fully evaluated, given the paucity of high-quality clinical trials. Based on data from preclinical studies, cell-based therapy is a promising treatment for ALS/MND. This review was first published in 2015 when the first clinical trials of cell-based therapies were still in progress. We undertook this update to incorporate evidence now available from randomised controlled trials (RCTs).\nObjectives\nTo assess the effects of cell-based therapy for people with ALS/MND, compared with placebo or no treatment.\nSearch methods\nOn 31 July 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched two clinical trials registries for ongoing or unpublished studies.\nSelection criteria\nWe included RCTs that assigned people with ALS/MND to receive cell-based therapy versus a placebo or no additional treatment. Co-interventions were allowed, provided that they were given to each group equally.\nData collection and analysis\nWe followed standard Cochrane methodology.\nMain results\nTwo RCTs involving 112 participants were eligible for inclusion in this review. One study compared autologous bone marrow-mesenchymal stem cells (BM-MSC) plus riluzole versus control (riluzole only), while the other study compared combined intramuscular and intrathecal administration of autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF) to placebo. The latter study was reported as an abstract and provided no numerical data. Both studies were funded by biotechnology companies.\nThe only study that contributed to the outcome data in the review involved 64 participants, comparing BM-MSC plus riluzole versus control (riluzole only). It reported outcomes after four to six months. It had a low risk of selection bias, detection bias and reporting bias, but a high risk of performance bias and attrition bias. The certainty of evidence was low for all major efficacy outcomes, with imprecision as the main downgrading factor, because the range of plausible estimates, as shown by the 95% confidence intervals (CIs), encompassed a range that would likely result in different clinical decisions.\nFunctional impairment, expressed as the mean change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score from baseline to six months after cell injection was slightly reduced (better) in the BM-MSC group compared to the control group (mean difference (MD) 3.38, 95% CI 1.22 to 5.54; 1 RCT, 56 participants; low-certainty evidence). ALSFRS-R has a range from 48 (normal) to 0 (maximally impaired); a change of 4 or more points is considered clinically important. The trial did not report outcomes at 12 months. There was no clear difference between the BM-MSC and the no treatment group in change in respiratory function (per cent predicted forced vital capacity; FVC%; MD –0.53, 95% CI –5.37 to 4.31; 1 RCT, 56 participants; low-certainty evidence); overall survival at six months (risk ratio (RR) 1.07, 95% CI 0.94 to 1.22; 1 RCT, 64 participants; low-certainty evidence); risk of total adverse events (RR 0.86, 95% CI 0.62 to 1.19; 1 RCT, 64 participants; low-certainty evidence) or serious adverse events (RR 0.47, 95% CI 0.13 to 1.72; 1 RCT, 64 participants; low-certainty evidence). The study did not measure muscle strength.\nAuthors' conclusions\nCurrently, there is a lack of high-certainty evidence to guide practice on the use of cell-based therapy to treat ALS/MND. Uncertainties remain as to whether this mode of therapy is capable of restoring muscle function, slowing disease progression, and improving survival in people with ALS/MND. Although one RCT provided low-certainty evidence that BM-MSC may slightly reduce functional impairment measured on the ALSFRS-R after four to six months, this was a small phase II trial that cannot be used to establish efficacy.\nWe need large, prospective RCTs with long-term follow-up to establish the efficacy and safety of cellular therapy and to determine patient-, disease- and cell treatment-related factors that may influence the outcome of cell-based therapy. The major goals of future research are to determine the appropriate cell source, phenotype, dose and method of delivery, as these will be key elements in designing an optimal cell-based therapy programme for people with ALS/MND. Future research should also explore novel treatment strategies, including combinations of cellular therapy and standard or novel neuroprotective agents, to find the best possible approach to prevent or reverse the neurological deficit in ALS/MND, and to prolong survival in this debilitating and fatal condition.\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": "Amyotrophic lateral sclerosis (ALS; also known as motor neuron disease or MND) is a condition in which nerves in the brain and spinal cord that control movement (motor neurons) stop working. A person with ALS/MND has difficulty moving, swallowing, chewing and speaking, which become worse over time. Half of people with ALS/MND die within three years of their first symptoms. Weakness of muscles used in breathing often leads to death. The condition currently has no cure. Current treatment approaches largely focus on relieving symptoms to improve the quality of life of those affected.\nCell-based therapy can be defined as injection of cellular material into a person to treat disease. Various types of cell-based therapies have been tried in ALS/MND, including stem cell therapy. Stem cell therapy aims to provide new motor neurons, which may help stop or slow down disease progression in people with ALS/MND. Previous reviews supported the use of cell-based therapy as a potential means of delaying the disease course in ALS/MND, but these were mainly based on preclinical animal models. Randomised controlled trials (RCTs) provide the most reliable evidence. In RCTs, one group receives the test treatment, and the other, 'control' group has an alternative treatment, a dummy treatment (placebo) or no treatment. Well-performed RCTs provide the best evidence. Studies with no untreated group for comparison and small clinical trials have found no clinical benefits. Limited data from non-RCTs involving a small number of people with ALS/MND and a short follow-up period suggested that cell-based therapy may slow disease progression. There is currently no approved cell-based therapy for ALS/MND. We undertook this review to assess the RCT evidence now becoming available."
}
]
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query-laysum | 4614 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is a common acute infection in children. Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent anti-inflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics.\nObjectives\nTo assess the effects of systemic corticosteroids (oral or parenteral), with or without antibiotics, for AOM in children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) which contains the Cochrane ARI Group's Specialised Register, MEDLINE (Ovid), Embase (Elsevier), CINAHL (EBSCO), Web of Science (Thomson Reuters), and LILACS (BIREME) for published studies, and ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for completed and ongoing studies, to 20 February 2018. We checked the reference lists of all primary studies and review articles for additional references and contacted experts in the field to identify additional unpublished materials.\nSelection criteria\nWe included randomised controlled trials of children with AOM that compared any systemic corticosteroid (oral or parenteral) with placebo, either with antibiotics (corticosteroid plus antibiotic versus placebo plus antibiotic) or without antibiotics (corticosteroid versus placebo).\nData collection and analysis\nThree review authors (EDS, RR, YP) independently screened the titles and abstracts and retrieved the full texts of potentially relevant studies. We independently extracted study characteristics and outcome data from the included studies, and assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed study quality using the GRADE method.\nMain results\nWe included two studies involving 252 children with AOM aged from three months to six years receiving hospital ambulatory care who were treated with intramuscular ceftriaxone, and who were then randomised to the corticosteroid group (corticosteroid and corticosteroid plus antihistamine) or the placebo group (antihistamine and double placebo). In one study, children also had a needle aspiration of middle ear fluid. Both studies were at unclear risk of bias for allocation concealment, and unclear to high risk of bias for selective reporting.\nOne study (N = 179) included pain as an outcome, but we were unable to derive the proportion of children with persistent pain at Day 5 and Day 14. Reduction of overall or specific symptoms was presented as improvement in clinical symptoms and resolution of inflamed tympanic membranes without the need for additional antibiotic treatment: at Day 5 (94% of children in the treatment group (N = 89) versus 89% in the placebo group (N = 90); risk ratio (RR) 1.06, 95% confidence interval (CI) 0.97 to 1.16) and Day 14 (91% versus 87%; RR 1.05, 95% CI 0.95 to 1.17). Low-quality evidence meant that we are uncertain of the effectiveness of corticosteroids for this outcome.\nThe second study (N = 73) reported a reduction of overall or specific symptoms without additional antibiotic treatment during the first two weeks as a favourable outcome. Children in the treatment group had more favourable outcomes (adjusted odds ratio 65.9, 95% CI 1.28 to 1000; P = 0.037), although the numbers were small. We were unable to pool the results with the other study because it did not report the proportion of children with this outcome by treatment group. Only one study reported adverse effects of corticosteroids (e.g. drowsiness, nappy rash), but did not quantify incidence, so we were unable to draw conclusions about adverse effects. Neither study reported a reduction in overall or specific symptom duration.\nAuthors' conclusions\nThe evidence for the effect of systemic corticosteroids on AOM is of low to very low quality, meaning the effect of systemic corticosteroids on important clinical outcomes in AOM remains uncertain. Large, high-quality studies are required to resolve the question.\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": "The National Institutes of Health (NIH) and the National Center for Research Resources, NIH, US Public Health Service funded both studies. Pharmaceutical companies provided the drug but did not contribute any other scientific or financial support."
}
]
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query-laysum | 4615 | [
{
"role": "user",
"content": "Abstract: Background\nConvalescent plasma may reduce mortality in patients with viral respiratory diseases, and is being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). A thorough understanding of the current body of evidence regarding benefits and risks of this intervention is required.\nObjectives\nTo assess the effectiveness and safety of convalescent plasma transfusion in 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 Global literature on coronavirus disease Research Database, MEDLINE, Embase, Cochrane COVID-19 Study Register, and the Epistemonikos COVID-19 L*OVE Platform. We searched monthly until 03 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating convalescent plasma 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 evaluating standard immunoglobulin.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies we used RoB 2. We used the GRADE approach to rate the certainty of evidence for the following outcomes: all-cause mortality at up to day 28, worsening and improvement of clinical status (for individuals with moderate to severe disease), hospital admission or death, COVID-19 symptoms resolution (for individuals with mild disease), quality of life, grade 3 or 4 adverse events, and serious adverse events.\nMain results\nIn this fourth review update version, we included 33 RCTs with 24,861 participants, of whom 11,432 received convalescent plasma. Of these, nine studies are single-centre studies and 24 are multi-centre studies. Fourteen studies took place in America, eight in Europe, three in South-East Asia, two in Africa, two in western Pacific and three in eastern Mediterranean regions and one in multiple regions. We identified a further 49 ongoing studies evaluating convalescent plasma, and 33 studies reporting as being completed.\nIndividuals with a confirmed diagnosis of COVID-19 and moderate to severe disease\n29 RCTs investigated the use of convalescent plasma for 22,728 participants with moderate to severe disease. 23 RCTs with 22,020 participants compared convalescent plasma to placebo or standard care alone, five compared to standard plasma and one compared to human immunoglobulin. We evaluate subgroups on detection of antibodies detection, symptom onset, country income groups and several co-morbidities in the full text.\nConvalescent plasma versus placebo or standard care alone\nConvalescent plasma does not reduce all-cause mortality at up to day 28 (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.92 to 1.03; 220 per 1000; 21 RCTs, 19,021 participants; high-certainty evidence). It has little to no impact on need for invasive mechanical ventilation, or death (RR 1.03, 95% CI 0.97 to 1.11; 296 per 1000; 6 RCTs, 14,477 participants; high-certainty evidence) and has no impact on whether participants are discharged from hospital (RR 1.00, 95% CI 0.97 to 1.02; 665 per 1000; 6 RCTs, 12,721 participants; high-certainty evidence). Convalescent plasma may have little to no impact on quality of life (MD 1.00, 95% CI −2.14 to 4.14; 1 RCT, 483 participants; low-certainty evidence). Convalescent plasma may have little to no impact on the risk of grades 3 and 4 adverse events (RR 1.17, 95% CI 0.96 to 1.42; 212 per 1000; 6 RCTs, 2392 participants; low-certainty evidence). It has probably little to no effect on the risk of serious adverse events (RR 1.14, 95% CI 0.91 to 1.44; 135 per 1000; 6 RCTs, 3901 participants; moderate-certainty evidence).\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces or increases all-cause mortality at up to day 28 (RR 0.73, 95% CI 0.45 to 1.19; 129 per 1000; 4 RCTs, 484 participants; very low-certainty evidence). We are uncertain whether convalescent plasma reduces or increases the need for invasive mechanical ventilation, or death (RR 5.59, 95% CI 0.29 to 108.38; 311 per 1000; 1 study, 34 participants; very low-certainty evidence) and whether it reduces or increases the risk of serious adverse events (RR 0.80, 95% CI 0.55 to 1.15; 236 per 1000; 3 RCTs, 327 participants; very low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus human immunoglobulin\nConvalescent plasma may have little to no effect on all-cause mortality at up to day 28 (RR 1.07, 95% CI 0.76 to 1.50; 464 per 1000; 1 study, 190 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nIndividuals with a confirmed diagnosis of SARS-CoV-2 infection and mild disease\nWe identified two RCTs reporting on 536 participants, comparing convalescent plasma to placebo or standard care alone, and two RCTs reporting on 1597 participants with mild disease, comparing convalescent plasma to standard plasma.\nConvalescent plasma versus placebo or standard care alone\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (odds ratio (OR) 0.36, 95% CI 0.09 to 1.46; 8 per 1000; 2 RCTs, 536 participants; very low-certainty evidence). It may have little to no effect on admission to hospital or death within 28 days (RR 1.05, 95% CI 0.60 to 1.84; 117 per 1000; 1 RCT, 376 participants; low-certainty evidence), on time to COVID-19 symptom resolution (hazard ratio (HR) 1.05, 95% CI 0.85 to 1.30; 483 per 1000; 1 RCT, 376 participants; low-certainty evidence), on the risk of grades 3 and 4 adverse events (RR 1.29, 95% CI 0.75 to 2.19; 144 per 1000; 1 RCT, 376 participants; low-certainty evidence) and the risk of serious adverse events (RR 1.14, 95% CI 0.66 to 1.94; 133 per 1000; 1 RCT, 376 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (OR 0.30, 95% CI 0.05 to 1.75; 2 per 1000; 2 RCTs, 1597 participants; very low-certainty evidence). It probably reduces admission to hospital or death within 28 days (RR 0.49, 95% CI 0.31 to 0.75; 36 per 1000; 2 RCTs, 1595 participants; moderate-certainty evidence). Convalescent plasma may have little to no effect on initial symptom resolution at up to day 28 (RR 1.12, 95% CI 0.98 to 1.27; 1 RCT, 416 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nThis is a living systematic review. We search monthly for new evidence and update the review when we identify relevant new evidence.\nAuthors' conclusions\nFor the comparison of convalescent plasma versus placebo or standard care alone, our certainty in the evidence that convalescent plasma for individuals with moderate to severe disease does not reduce mortality and has little to no impact on clinical improvement or worsening is high. It probably has little to no effect on SAEs. For individuals with mild disease, we have very-low to low certainty evidence for most primary outcomes and moderate certainty for hospital admission or death. There are 49 ongoing studies, and 33 studies reported as complete in a trials registry. Publication of ongoing studies might resolve some of the uncertainties around convalescent plasma therapy for people with asymptomatic or mild disease.\n\nGiven the provided abstract, please respond to the following query: \"serious unwanted effects,\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "serious unwanted effects,about 118 in 1000 people may be at risk to have serious unwanted effects compared to 133 in 1000 people given convalescent plasma (6 studies, 4901 people)."
}
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query-laysum | 4616 | [
{
"role": "user",
"content": "Abstract: Background\nChildren who are securely attached to at least one parent are able to be comforted by that parent when they are distressed and explore the world confidently by using that parent as a 'secure base'. Research suggests that a secure attachment enables children to function better across all aspects of their development. Promoting secure attachment, therefore, is a goal of many early interventions. Attachment is mediated through parental sensitivity to signals of distress from the child. One means of improving parental sensitivity is through video feedback, which involves showing a parent brief moments of their interaction with their child, to strengthen their sensitivity and responsiveness to their child's signals.\nObjectives\nTo assess the effects of video feedback on parental sensitivity and attachment security in children aged under five years who are at risk for poor attachment outcomes.\nSearch methods\nIn November 2018 we searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, nine other databases and two trials registers. We also handsearched the reference lists of included studies, relevant systematic reviews, and several relevant websites\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs that assessed the effects of video feedback versus no treatment, inactive alternative intervention, or treatment as usual for parental sensitivity, parental reflective functioning, attachment security and adverse effects in children aged from birth to four years 11 months.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review includes 22 studies from seven countries in Europe and two countries in North America, with a total of 1889 randomised parent-child dyads or family units. Interventions targeted parents of children aged under five years, experiencing a wide range of difficulties (such as deafness or prematurity), or facing challenges that put them at risk of attachment issues (for example, parental depression). Nearly all studies reported some form of external funding, from a charitable organisation (n = 7) or public body, or both (n = 18).\nWe considered most studies as being at low or unclear risk of bias across the majority of domains, with the exception of blinding of participants and personnel, where we assessed all studies as being at high risk of performance bias. For outcomes where self-report measures were used, such as parental stress and anxiety, we rated all studies at high risk of bias for blinding of outcome assessors.\nParental sensitivity. A meta-analysis of 20 studies (1757 parent-child dyads) reported evidence of that video feedback improved parental sensitivity compared with a control or no intervention from postintervention to six months' follow-up (standardised mean difference (SMD) 0.34, 95% confidence interval (CI) 0.20 to 0.49, moderate-certainty evidence). The size of the observed impact compares favourably to other, similar interventions.\nParental reflective functioning. No studies reported this outcome.\nAttachment security. A meta-analysis of two studies (166 parent-child dyads) indicated that video feedback increased the odds of being securely attached, measured using the Strange Situation Procedure, at postintervention (odds ratio 3.04, 95% CI 1.39 to 6.67, very low-certainty evidence). A second meta-analysis of two studies (131 parent-child dyads) that assessed attachment security using a different measure (Attachment Q-sort) found no effect of video feedback compared with the comparator groups (SMD 0.02, 95% CI −0.33 to 0.38, very low-certainty evidence).\nAdverse events. Eight studies (537 parent-child dyads) contributed data at postintervention or short-term follow-up to a meta-analysis of parental stress, and two studies (311 parent-child dyads) contributed short-term follow-up data to a meta-analysis of parental anxiety. There was no difference between intervention and comparator groups for either outcome. For parental stress the SMD between video feedback and control was −0.09 (95% CI −0.26 to 0.09, low-certainty evidence), while for parental anxiety the SMD was −0.28 (95% CI −0.87 to 0.31, very low-certainty evidence).\nChild behaviour. A meta-analysis of two studies (119 parent-child dyads) at long-term follow-up found no evidence of the effectiveness of video feedback on child behaviour (SMD 0.04, 95% CI −0.33 to 0.42, very low-certainty evidence).\nA moderator analysis found no evidence of an effect for the three prespecified variables (intervention type, number of feedback sessions and participating carer) when jointly tested. However, parent gender (both parents versus only mothers or only fathers) potentially has a statistically significant negative moderation effect, though only at α (alpha) = 0.1\nAuthors' conclusions\nThere is moderate-certainty evidence that video feedback may improve sensitivity in parents of children who are at risk for poor attachment outcomes due to a range of difficulties. There is currently only little, very low-certainty evidence regarding the impact of video feedback on attachment security, compared with control: results differed based on the type of measure used, and follow-up was limited in duration. There is no evidence that video feedback has an impact on parental stress or anxiety (low- and very low-certainty evidence, respectively). Further evidence is needed regarding the longer-term impact of video feedback on attachment and more distal outcomes such as children's behaviour (very low-certainty evidence). Further research is needed on the impact of video-feedback on paternal sensitivity and parental reflective functioning, as no study measured these outcomes. This review is limited by the fact that the majority of included parents were mothers.\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Video feedback may be a helpful method of improving parental sensitivity, but there is currently little or no evidence that it improves child attachment security, parental stress, parental anxiety or child behaviour. More research is needed on the effects of video feedback on other outcomes, including parental reflective functioning, and in fathers."
}
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query-laysum | 4617 | [
{
"role": "user",
"content": "Abstract: Background\nFetal malposition (occipito-posterior and persistent occipito-transverse) in labour is associated with adverse maternal and infant outcomes. Whether use of maternal postures can improve these outcomes is unclear. This Cochrane Review of maternal posture in labour is one of two new reviews replacing a 2007 review of maternal postures in pregnancy and labour.\nObjectives\nTo assess the effect of specified maternal postures for women with fetal malposition in labour on maternal and infant morbidity compared to other postures.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (13 July 2021), and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or cluster-RCTs conducted among labouring women with a fetal malposition confirmed by ultrasound or clinical examination, comparing a specified maternal posture with another posture. Quasi-RCTs and cross-over trials were not eligible for inclusion.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, risk of bias, and performed data extraction. We used mean difference (MD) for continuous variables, and risk ratios (RRs) for dichotomous variables, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included eight eligible studies with 1766 women.\nAll studies reported some form of random sequence generation but were at high risk of performance bias due to lack of blinding. There was a high risk of selection bias in one study, detection bias in two studies, attrition bias in two studies, and reporting bias in two studies.\nHands and knees\nThe use of hands and knees posture may have little to no effect on operative birth (average RR 1.14, 95% CI 0.87 to 1.50; 3 trials, 721 women; low-certainty evidence) and caesarean section (RR 1.34, 95% CI 0.96 to 1.87; 3 trials, 721 women; low-certainty evidence) but the evidence is uncertain; and very uncertain for epidural use (average RR 0.74, 95% CI 0.41 to 1.31; 2 trials, 282 women; very low-certainty evidence), instrumental vaginal birth (average RR 1.04, 95% CI 0.57 to 1.90; 3 trials, 721 women; very low-certainty evidence), severe perineal tears (average RR 0.88, 95% CI 0.03 to 22.30; 2 trials, 586 women; very low-certainty evidence), maternal satisfaction (average RR 1.02, 95% CI 0.68 to 1.54; 3 trials, 350 women; very low-certainty evidence), and Apgar scores less than seven at five minutes (RR 0.71, 95% CI 0.21 to 2.34; 2 trials, 586 babies; very low-certainty evidence).\nNo data were reported for the hands and knees comparisons for postpartum haemorrhage, serious neonatal morbidity, death (stillbirth or death of liveborn infant), admission to neonatal intensive care, neonatal encephalopathy, need for respiratory support, and neonatal jaundice requiring phototherapy.\nLateral postures\nThe use of lateral postures may have little to no effect on reducing operative birth (average RR 0.72, 95% CI 0.43 to 1.19; 4 trials, 871 women; low-certainty evidence), caesarean section (average RR 0.78, 95% CI 0.44 to 1.39; 4 trials, 871 women; low-certainty evidence), instrumental vaginal birth (average RR 0.73, 95% CI 0.39 to 1.36; 4 trials, 871 women; low-certainty evidence), and maternal satisfaction (RR 0.96, 95% CI 0.84 to 1.09; 2 trials, 451 women; low-certainty evidence), but the evidence is uncertain. The evidence is very uncertain about the effect of lateral postures on severe perineal tears (RR 0.66, 95% CI 0.17 to 2.48; 3 trials, 609 women; very low-certainty evidence), postpartum haemorrhage (RR 0.90, 95% CI 0.48 to 1.70; 1 trial, 322 women; very low-certainty evidence), serious neonatal morbidity (RR 1.41, 95% CI 0.64 to 3.12; 3 trials, 752 babies; very low-certainty evidence), Apgar scores less than seven at five minutes (RR 0.25, 95% CI 0.03 to 2.24; 1 trial, 322 babies; very low-certainty evidence), admissions to neonatal intensive care (RR 1.41, 95% CI 0.64 to 3.12; 2 trials, 542 babies; very low-certainty evidence) and neonatal death (stillbirth or death of liveborn) (1 trial, 210 women and their babies; no events).\nFor the lateral posture comparisons, no data were reported for epidural use, neonatal encephalopathy, need for respiratory support, and neonatal jaundice requiring phototherapy. We were not able to estimate the outcome death (stillbirth or death of liveborn infant) due to no events (1 trial, 210 participants).\nAuthors' conclusions\nWe found low- and very low-certainty evidence which indicated that the use of hands and knees posture or lateral postures in women in labour with a fetal malposition may have little or no effect on health outcomes of the mother or her infant. If a woman finds the use of hands and knees or lateral postures in labour comfortable there is no reason why they should not choose to use them. Further research is needed on the use of hands and knees and lateral postures for women with a malposition in labour. Trials should include further assessment of semi-prone postures, same-side-as-fetus lateral postures with or without hip hyperflexion, or both, and consider interventions of longer duration or that involve the early second stage of labour.\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": "The way a pregnant woman is positioned during labour may help rotate a baby so that the back of the baby's head lies towards the front of the mother's abdomen. This improved position may help the mother and baby have a more normal labour and birth. However, it is not yet known which posture, if any, is effective and when is the best time to use it.\nA systematic review of studies of positions (postures) used by women in labour with a baby in a malposition can provide answers on whether the postures improve birth and other health outcomes for mothers and babies. The summary of this review can be used to update clinical practice guidelines.\nA Cochrane Review in 2007 reported that the use of the 'hands and knees' posture in labour was ineffective for malposition, but it did reduce labouring women's backache. Since then, more trials have been conducted, some using other postures; these need evaluating to see if those postures work."
}
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query-laysum | 4618 | [
{
"role": "user",
"content": "Abstract: Background\nPalmoplantar pustulosis is a chronic inflammatory disease in which sterile, relapsing pustules appear on the palms and soles, possibly in conjunction with other symptoms. The previous Cochrane Review on this topic was published in 2006, before biological treatments were extensively used.\nObjectives\nTo assess the effects of interventions for chronic palmoplantar pustulosis to induce and maintain complete remission.\nSearch methods\nWe searched the following databases up to March 2019: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of the included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe considered RCTs including people with palmoplantar pustulosis or chronic palmoplantar pustular psoriasis assessing topical therapy, systemic therapy, combinations of topical or systemic therapies, or non-pharmacological therapies compared with placebo, no intervention, or each other.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our outcomes included 'Proportion of participants cleared or almost cleared', 'Proportion of participants with adverse effects serious or severe enough to cause withdrawal', 'Proportion of participants with at least 50% improvement in disease severity', and 'Proportion of participants with adverse effects'.\nMain results\nWe included 37 studies (1663 participants; mean age 50 years (range 34 to 63); 24% males). These studies reported condition severity differently. Around half of the included trials stated the setting (hospitals, community clinics, or both). More than half of the studies were at high risk of bias in at least one domain.\nOur included studies assessed mainly systemic treatments (retinoids, ciclosporin, biologics, etretinate + PUVA (combination of psoralens and long-wave ultraviolet radiation) therapy combined, and antibiotics), but also topical treatments (dermocorticoids, vitamin D) and phototherapy (PUVA, ultraviolet A1 (UVA1)). Other interventions were assessed by single studies. The most common comparator was placebo.\nAll results presented in this abstract were assessed in the short term (mean treatment duration was 11 weeks (range 8 to 24 weeks)) and are based on participants with chronic palmoplantar pustulosis. All outcome time point measurements were taken from baseline and assessed at the end of treatment. Short-term and long-term outcomes were defined as measurement up to 24 weeks after randomisation and between 24 and 104 weeks after randomisation, respectively.\nOne trial (188 participants) assessed the topical vitamin D derivative maxacalcitol versus placebo and found that maxacalcitol may be more effective than placebo in achieving clearance (risk ratio (RR) 7.83, 95% confidence interval (CI) 1.85 to 33.12; low-quality evidence), and the risk of adverse effects (such as mild local irritation, pruritus, and haematological or urinary test abnormalities) is probably similar in both groups (RR 0.87, 95% CI 0.64 to 1.19; moderate-quality evidence). Severity was not reported.\nTwo trials (49 participants) assessed PUVA therapy versus placebo or no treatment, providing very low-quality evidence. Adverse effects were reported with oral PUVA (including nausea, ankle swelling, and non-purulent conjunctivitis) and with local PUVA (including blistering, erythema, and pruritus).\nWith regard to the systemic retinoid alitretinoin, one trial (33 participants; moderate-quality evidence) showed that alitretinoin probably makes little or no difference in reducing severity when compared to placebo (RR 0.69, 95% CI 0.36 to 1.30). A similar number of adverse events were reported in both treatment groups, including headache, cheilitis, nausea, arthralgia, and nasopharyngitis (RR 0.84, 95% CI 0.61 to 1.17). Clearance was not reported.\nThere may be little or no difference between etanercept and placebo in achieving clearance (RR 1.64, 95% CI 0.08 to 34.28; 1 study; 15 participants; low-quality evidence); however, the 95% CI was very wide, showing there may be a difference between groups. Severity was not measured.\nMore patients treated with placebo may achieve reduced severity than those treated with ustekinumab, but the wide 95% CI indicates there might be little or no difference between groups and there might be greater effect with ustekinumab (RR 0.48, 95% CI 0.11 to 2.13; 1 study; 33 participants; low-quality evidence). Clearance was not reported.\nIt is uncertain whether guselkumab increases clearance when compared to placebo (2 studies; 154 participants) because the quality of evidence is very low, but guselkumab probably better reduces disease severity (RR 2.88, 95% CI 1.24 to 6.69; 1 study; 49 participants; moderate-quality evidence).\nSecukinumab is probably superior to placebo in reducing severity (RR 1.55, 95% CI 1.02 to 2.35; 1 study; 157 participants; moderate-quality evidence), but our clearance outcome was not reported. None of these trials reported on occurrence of adverse effects.\nOnly two of the studies discussed above reported adverse effects serious or severe enough to cause withdrawal. Guselkumab may cause more serious adverse events when compared to placebo, but there is uncertainty due to the very wide 95% CI showing there may be little or no difference and showing more events with placebo (RR 2.88, 95% CI 0.32 to 25.80; 1 study; 49 participants; low-quality evidence). Secukinumab probably causes more serious adverse events than placebo (RR 3.29, 95% CI 1.40 to 7.75; 1 study; 157 participants; moderate-quality evidence).\nAuthors' conclusions\nEvidence is lacking for major chronic palmoplantar pustulosis treatments such as superpotent corticosteroids, phototherapy, acitretin, methotrexate, and ciclosporin. Risk of bias and imprecision limit our confidence.\nMaxacalcitol may be more effective than placebo in achieving clearance in the short term (low-quality evidence), and the risk of adverse effects is probably similar (moderate-quality evidence). Oral alitretinoin is probably no more effective than placebo in reducing severity, with a similar risk of adverse effects (moderate-quality evidence).\nRegarding biological treatments, we are uncertain of the effect of etanercept on clearance and the effect of ustekinumab on severity (low-quality evidence). Secukinumab and guselkumab are probably superior to placebo in reducing severity (moderate-quality evidence). Adverse events not requiring withdrawal were not reported for these treatments.\nReporting of serious adverse effects was incomplete: compared to placebo, secukinumab probably caused more participant withdrawals (moderate-quality evidence), but we are uncertain of the effect of guselkumab (low-quality evidence).\nFuture trials should assess commonly used treatments using validated severity and quality of life scales.\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": "Palmoplantar pustulosis negatively affects a person's life; there is no cure or standard treatment. Over time, the skin becomes thicker and redder, and may develop cracks or flake off as scales.\nSymptoms are treated with topical medicines (usually corticosteroids), systemic medicines (medicines injected or taken by mouth that work throughout the entire body; usually medicines based on vitamin A or D), or phototherapy (ultraviolet light treatment)."
}
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query-laysum | 4619 | [
{
"role": "user",
"content": "Abstract: Background\nSucrose has been examined for calming and pain-relieving effects in neonates for invasive procedures such as heel lance.\nObjectives\nTo assess the effectiveness of sucrose for relieving pain from heel lance in neonates in terms of immediate and long-term outcomes\nSearch methods\nWe searched (February 2022): CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, and three trial registries.\nSelection criteria\nWe included randomised controlled trials where term and/or preterm neonates received sucrose for heel lances. Comparison treatments included water/placebo/no intervention, non-nutritive sucking (NNS), glucose, breastfeeding, breast milk, music, acupuncture, facilitated tucking, and skin-to-skin care.\nData collection and analysis\nWe used standard Cochrane methods. We reported mean differences (MD) with 95% confidence intervals (CI) using the fixed-effect model for continuous outcome measures. We assessed heterogeneity by the I2 test. We used GRADE to assess certainty of evidence.\nMain results\nWe included 55 trials (6273 infants): 29 included term neonates, 22 included preterm neonates, and four included both. Heel lance was investigated in 50 trials; 15 investigated other minor painful procedures in addition to lancing.\nSucrose vs control\nThe evidence suggests that sucrose probably results in a reduction in PIPP scores compared to the control group at 30 seconds (MD -1.74 (95% CI -2.11 to -1.37); I2 = 62%; moderate-certainty evidence) and 60 seconds after lancing (MD -2.14, 95% CI -3.34 to -0.94; I2 = 0%; moderate-certainty evidence).\nThe evidence is very uncertain about the effects of sucrose on DAN scores compared to water at 30 seconds after lancing (MD -1.90, 95% CI -8.58 to 4.78; heterogeneity not applicable (N/A); very low-certainty evidence).\nThe evidence suggests that sucrose probably results in a reduction in NIPS scores compared to water immediately after lancing (MD -2.00, 95% CI -2.42 to -1.58; heterogeneity N/A; moderate-certainty evidence).\nSucrose vs NNS\nThe evidence is very uncertain about the effect of sucrose on PIPP scores compared to NNS during the recovery period after lancing (MD 0.60, 95% CI -0.30 to 1.50; heterogeneity not applicable; very low-certainty evidence) and on DAN scores at 30 seconds after lancing (MD -1.20, 95% CI -7.87 to 5.47; heterogeneity N/A; very low-certainty evidence).\nSucrose + NNS vs NNS\nThe evidence is very uncertain about the effect of sucrose + NNS on PIPP scores compared to NNS during lancing (MD -4.90, 95% CI -5.73 to -4.07; heterogeneity not applicable; very low-certainty evidence) and during recovery after lancing (MD -3.80, 95% CI -4.47 to -3.13; heterogeneity N/A; very low-certainty evidence).\nThe evidence is very uncertain about the effects of sucrose + NNS on NFCS scores compared to water + NNS during lancing (MD -0.60, 95% CI -1.47 to 0.27; heterogeneity N/A; very low-certainty evidence).\nSucrose vs glucose\nThe evidence suggests that sucrose results in little to no difference in PIPP scores compared to glucose at 30 seconds (MD 0.26, 95% CI -0.70 to 1.22; heterogeneity not applicable; low-certainty evidence) and 60 seconds after lancing (MD -0.02, 95% CI -0.79 to 0.75; heterogeneity N/A; low-certainty evidence).\nSucrose vs breastfeeding\nThe evidence is very uncertain about the effect of sucrose on PIPP scores compared to breastfeeding at 30 seconds after lancing (MD -0.70, 95% CI -0.49 to 1.88; I2 = 94%; very low-certainty evidence).\nThe evidence is very uncertain about the effect of sucrose on COMFORTneo scores compared to breastfeeding after lancing (MD -2.60, 95% CI -3.06 to -2.14; heterogeneity N/A; very low-certainty evidence).\nSucrose vs expressed breast milk\nThe evidence suggests that sucrose may result in little to no difference in PIPP-R scores compared to expressed breast milk during (MD 0.3, 95% CI -0.24 to 0.84; heterogeneity not applicable; low-certainty evidence) and at 30 seconds after lancing (MD 0.3, 95% CI -0.11 to 0.71; heterogeneity N/A; low-certainty evidence).\nThe evidence suggests that sucrose probably may result in slightly increased PIPP-R scores compared to expressed breast milk 60 seconds after lancing (MD 1.10, 95% CI 0.34 to 1.86; heterogeneity N/A; low-certainty evidence).\nThe evidence is very uncertain about the effect of sucrose on DAN scores compared to expressed breast milk 30 seconds after lancing (MD -1.80, 95% CI -8.47 to 4.87; heterogeneity N/A; very low-certainty evidence).\nSucrose vs laser acupuncture\nThere was no difference in PIPP-R scores between sucrose and music groups; however, data were reported as medians and IQRs.\nThe evidence is very uncertain about the effect of sucrose on NIPS scores compared to laser acupuncture during lancing (MD -0.86, 95% CI -1.43 to -0.29; heterogeneity N/A; very low-certainty evidence).\nSucrose vs facilitated tucking\nThe evidence is very uncertain about the effect of sucrose on total BPSN scores compared to facilitated tucking during lancing (MD -2.27, 95% CI -4.66 to 0.12; heterogeneity N/A; very low-certainty evidence) and during recovery after lancing (MD -0.31, 95% CI -1.72 to 1.10; heterogeneity N/A; very low-certainty evidence).\nSucrose vs skin-to-skin + water (repeated lancing)\nThe evidence suggests that sucrose results in little to no difference in PIPP scores compared to skin-to-skin + water at 30 seconds after 1st (MD 0.13, 95% CI -0.70 to 0.96); 2nd (MD -0.56, 95% CI -1.57 to 0.45); or 3rd lancing (MD-0.15, 95% CI -1.26 to 0.96); heterogeneity N/A, low-certainty evidence for all comparisons.\nThe evidence suggests that sucrose results in little to no difference in PIPP scores compared to skin-to-skin + water at 60 seconds after 1st (MD –0.61, 95% CI -1.55 to 0.33); 2nd (MD -0.12, 95% CI -0.99 to 0.75); or 3rd lancing (MD-0.40, 95% CI -1.48 to 0.68); heterogeneity N/A, low-certainty evidence for all comparisons.\nMinor adverse events required no intervention.\nAuthors' conclusions\nSucrose compared to control probably results in a reduction of PIPP scores 30 and 60 seconds after single heel lances (moderate-certainty evidence). Evidence is very uncertain about the effect of sucrose compared to NNS, breastfeeding, laser acupuncture, facilitated tucking, and the effect of sucrose + NNS compared to NNS in reducing pain. Sucrose compared to glucose, expressed breast milk, and skin-to-skin care shows little to no difference in pain scores. Sucrose combined with other nonpharmacologic interventions should be used with caution, given the uncertainty of evidence.\n\nGiven the provided abstract, please respond to the following query: \"What is sucrose analgesia?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sucrose (table sugar) is mixed with water in various concentrations (usually 24%) and is given to babies in very small amounts (e.g. a few drops) about two minutes before a painful procedure. Sucrose is also given with other nondrug pain-relieving interventions such as a pacifier (non-nutritive sucking - NNS) or when the baby is receiving skin-to-skin care."
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query-laysum | 4620 | [
{
"role": "user",
"content": "Abstract: Background\nPelvimetry assesses the size of a woman's pelvis aiming to predict whether she will be able to give birth vaginally or not. This can be done by clinical examination, or by conventional X-rays, computerised tomography (CT) scanning, or magnetic resonance imaging (MRI).\nObjectives\nTo assess the effects of pelvimetry (performed antenatally or intrapartum) on the method of birth, on perinatal mortality and morbidity, and on maternal morbidity. This review concentrates exclusively on women whose fetuses have a cephalic presentation.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (including quasi-randomised) assessing the use of pelvimetry versus no pelvimetry or assessing different types of pelvimetry in women with a cephalic presentation at or near term were included. Cluster trials were eligible for inclusion, but none were identified.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nFive trials with a total of 1159 women were included. All used X-ray pelvimetry to assess the pelvis. X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that examined other types of radiological pelvimetry or that compared clinical pelvimetry versus no pelvimetry.\nThe included trials were generally at high risk of bias. There is an overall high risk of performance bias due to lack of blinding of women and staff. Two studies were also at high risk of selection bias. We used GRADEpro software to grade evidence for our selected outcomes; for caesarean section we rated the evidence low quality and all the other outcomes (perinatal mortality, wound sepsis, blood transfusion, scar dehiscence and admission to special care baby unit) as very low quality. Downgrading was due to risk of bias relating to lack of allocation concealment and blinding, and imprecision of effect estimates.\nWomen undergoing X-ray pelvimetry were more likely to have a caesarean section (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.19 to 1.52; 1159 women; 5 studies; low-quality evidence). There were no clear differences between groups for perinatal outcomes: perinatal mortality (RR 0.53, 95% CI 0.19 to 1.45; 1159 infants; 5 studies; very low-quality evidence), perinatal asphyxia (RR 0.66, 95% CI 0.39 to 1.10; 305 infants; 1 study), and admission to special care baby unit (RR 0.20, 95% CI 0.01 to 4.13; 288 infants; 1 study; very low-quality evidence). Other outcomes assessed were wound sepsis (RR 0.83, 95% CI 0.26 to 2.67; 288 women; 1 study; very low-quality evidence), blood transfusion (RR 1.00, 95% CI 0.39 to 2.59; 288 women; 1 study; very low-quality evidence), and scar dehiscence (RR 0.59, 95% CI 0.14 to 2.46; 390 women; 2 studies; very low-quality evidence). Again, no clear differences were found for these outcomes between the women who received X-ray pelvimetry and those who did not. Apgar score less than seven at five minutes was not reported in any study.\nAuthors' conclusions\nX-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that used other types or pelvimetry (other radiological examination or clinical pelvimetry versus no pelvimetry). There is not enough evidence to support the use of X-ray pelvimetry for deciding on mode of delivery in women whose fetuses have a cephalic presentation. Women who undergo an X-ray pelvimetry may be more likely to have a caesarean section.\nFurther research should be directed towards defining whether there are specific clinical situations in which pelvimetry can be shown to be of value. Newer methods of pelvimetry (CT, MRI) should be subjected to randomised trials to assess their value. Further trials of X-ray pelvimetry in cephalic presentations would be of value if large enough to assess the effect on perinatal mortality.\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"
},
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"role": "assistant",
"content": "Sometimes, normal labour does not progress because the baby's head is too big, or the pelvis of the mother is too small, for the baby to pass through. This is called \"cephalo-pelvic disproportion\" or \"obstructed labour\" which may lead to an emergency caesarean section with possible risks for both mother and baby. A pregnant mother or her caregiver might be worried that disproportion could occur and for this reason, pelvimetry can be performed either before or during labour. It can be undertaken by clinical examination, X-ray, CT-scan or MRI. Pelvimetry measures the diameters of the pelvis and the baby's head. However, doing a pelvimetry also has implications: clinical examination might be very uncomfortable for the mother, X-ray and CT-scanning might be harmful for the baby and MRI is very expensive. All of these techniques have to be performed meticulously by experienced and skilled people to have any real value.\nIf we could diagnose the disproportion accurately before birth using pelvimetry, we might reduce the need for an emergency caesarean section and plan an elective procedure, with better outcomes for the baby and less complications for the mother."
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query-laysum | 4621 | [
{
"role": "user",
"content": "Abstract: Background\nOral anticoagulants may improve the survival of people with cancer through an antithrombotic effect, yet increase the risk of bleeding.\nObjectives\nTo evaluate the efficacy and safety of oral anticoagulants in ambulatory people with cancer undergoing chemotherapy, targeted therapy, immunotherapy, or radiotherapy (either alone or in combination), with no standard therapeutic or prophylactic indication for anticoagulation.\nSearch methods\nWe conducted comprehensive searches on 14 June 2021, following the original electronic searches performed in February 2016 (last major search). We electronically searched the following databases: CENTRAL, MEDLINE, Embase. In addition, we handsearched conference proceedings, checked references of included studies, and searched for ongoing studies. As part of the living systematic review approach, we are running continual searches and will incorporate new evidence rapidly after it is identified.\nSelection criteria\nWe included randomised controlled trials (RCTs) assessing the benefits and harms of vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) in ambulatory people with cancer (i.e., not hospital inpatients during the time of their participation in trials) These people are typically undergoing systemic anticancer therapy, possibly including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, but otherwise have no standard therapeutic or prophylactic indication for anticoagulation.\nData collection and analysis\nUsing a standardised form, two review authors independently extracted data on study design, participants, intervention outcomes of interest, and risk of bias. Outcomes of interest included all-cause mortality, pulmonary embolism, symptomatic deep vein thrombosis (DVT), major bleeding, minor bleeding and health-related quality of life. We assessed the certainty of evidence for each outcome using the GRADE approach.\nMain results\nOf 12,620 identified citations, 10 RCTs fulfilled the inclusion criteria. The oral anticoagulant was a vitamin K antagonist (VKA) in six of these RCTs, and a direct oral anticoagulant (DOAC) in the remaining four RCTs (three studies used apixaban; one used rivaroxaban). The comparator was either placebo or no prophylaxis.\nCompared to no prophylaxis, vitamin K antagonists (VKAs) probably reduce mortality at six months slightly (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.77 to 1.13; risk difference (RD) 22 fewer per 1000, 95% CI 72 fewer to 41 more; moderate-certainty evidence), and probably reduce mortality at 12 months slightly (RR 0.95, 95% CI 0.87 to 1.03; RD 29 fewer per 1000, 95% CI 75 fewer to 17 more; moderate-certainty evidence). One study assessed the effect of a VKA compared to no prophylaxis on thrombosis; the evidence was very uncertain about the effect of VKA compared to no VKA on pulmonary embolism and symptomatic DVT (RR 1.05, 95% CI 0.07 to 16.58; RD 0 fewer per 1000, 95% CI 6 fewer to 98 more; very low-certainty evidence; RR 0.08, 95% CI 0.01 to 1.42; RD 35 fewer per 1000, 95% CI 37 fewer to 16 more; very low-certainty evidence, respectively). Also, VKAs probably increase major and minor bleeding at 12 months (RR 2.93, 95% CI 1.86 to 4.62; RD 107 more per 1000, 95% CI 48 more to 201 more; moderate-certainty evidence for major bleeding, and RR 3.14, 95% CI 1.85 to 5.32; RD 167 more per 1000, 95% CI 66 more to 337 more; moderate-certainty evidence for minor bleeding).\nCompared to no prophylaxis, at three to six months, direct oral anticoagulants (DOACs) probably reduce mortality slightly (RR 0.94, 95% CI 0.64 to 1.38, RD 11 fewer per 1000, 95% CI 67 fewer to 70 more; moderate-certainty evidence), probably reduce the risk of pulmonary embolism slightly compared to no prophylaxis (RR 0.48, 95% CI 0.24 to 0.98; RD 24 fewer per 1000, 95% CI 35 fewer to 1 fewer; moderate-certainty evidence), probably reduce symptomatic DVT slightly (RR 0.58, 95% CI 0.30 to 1.15; RD 21 fewer per 1000, 95% CI 35 fewer to 8 more; moderate-certainty evidence), probably do not increase major bleeding (RR 1.65, 95% CI 0.72 to 3.80; RD 9 more per 1000, 95% CI 4 fewer to 40 more; moderate-certainty evidence), and may increase minor bleeding (RR 3.58, 95% CI 0.55 to 23.44; RD 55 more per 1000, 95% CI 10 fewer to 482 more; low-certainty evidence).\nAuthors' conclusions\nIn ambulatory people with cancer undergoing chemotherapy, targeted therapy, immunotherapy, or radiotherapy (either alone or in combination), the current evidence on VKA thromboprophylaxis suggests that the harm of major bleeding might outweigh the benefit of reduction in venous thromboembolism. With DOACs, the benefit of reduction in venous thromboembolic events outweighs the risk of major bleeding.\nEditorial note: this is a living systematic review. Living systematic reviews offer a new approach to review updating in which the review is continually updated, incorporating relevant new evidence, as it becomes available. Please refer to the 'What's new' section in the Cochrane Database of Systematic Reviews for the current status of this review.\n\nGiven the provided abstract, please respond to the following query: \"What are blood thinners\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Blood thinners are medicines that help prevent blood from clotting. People at a high risk of getting blood clots can take blood thinners to reduce their chances of developing serious conditions such as heart attacks and strokes.\nWhy might blood-thinning treatment be helpful for people with cancer?\nPeople with cancer undergoing systemic treatment (any medication that travels through your body in the bloodstream to find, damage or destroy cancer cells, including chemotherapy, radiotherapy, immunotherapy and target therapy) are at increased risk of blood clots. While blood thinners can decrease the risk of getting blood clots, they can also increase the risk of serious and fatal bleeding. Therefore, it is important to understand the benefits and harms of using blood thinners in these people to allow them and their doctors to make informed decisions."
}
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query-laysum | 4622 | [
{
"role": "user",
"content": "Abstract: Background\nFluoride mouthrinses have been used extensively as a caries-preventive intervention in school-based programmes and by individuals at home. This is an update of the Cochrane review of fluoride mouthrinses for preventing dental caries in children and adolescents that was first published in 2003.\nObjectives\nThe primary objective is to determine the effectiveness and safety of fluoride mouthrinses in preventing dental caries in the child and adolescent population.\nThe secondary objective is to examine whether the effect of fluoride rinses is influenced by:\n• initial level of caries severity;\n• background exposure to fluoride in water (or salt), toothpastes or reported fluoride sources other than the study option(s); or\n• fluoride concentration (ppm F) or frequency of use (times per year).\nSearch methods\nWe searched the following electronic databases: Cochrane Oral Health's Trials Register (whole database, to 22 April 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 3), MEDLINE Ovid (1946 to 22 April 2016), Embase Ovid (1980 to 22 April 2016), CINAHL EBSCO (the Cumulative Index to Nursing and Allied Health Literature, 1937 to 22 April 2016), LILACS BIREME (Latin American and Caribbean Health Science Information Database, 1982 to 22 April 2016), BBO BIREME (Bibliografia Brasileira de Odontologia; from 1986 to 22 April 2016), Proquest Dissertations and Theses (1861 to 22 April 2016) and Web of Science Conference Proceedings (1990 to 22 April 2016). We undertook a search for ongoing trials on the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform. We placed no restrictions on language or date of publication when searching electronic databases. We also searched reference lists of articles and contacted selected authors and manufacturers.\nSelection criteria\nRandomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated, comparing fluoride mouthrinse with placebo or no treatment in children up to 16 years of age. Study duration had to be at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in permanent teeth (D(M)FS).\nData collection and analysis\nAt least two review authors independently performed study selection, data extraction and risk of bias assessment. We contacted study authors for additional information when required. The primary measure of effect was the prevented fraction (PF), that is, the difference in mean caries increments between treatment and control groups expressed as a percentage of the mean increment in the control group. We conducted random-effects meta-analyses where data could be pooled. We examined potential sources of heterogeneity in random-effects metaregression analyses. We collected adverse effects information from the included trials.\nMain results\nIn this review, we included 37 trials involving 15,813 children and adolescents. All trials tested supervised use of fluoride mouthrinse in schools, with two studies also including home use. Almost all children received a fluoride rinse formulated with sodium fluoride (NaF), mostly on either a daily or weekly/fortnightly basis and at two main strengths, 230 or 900 ppm F, respectively. Most studies (28) were at high risk of bias, and nine were at unclear risk of bias.\nFrom the 35 trials (15,305 participants) that contributed data on permanent tooth surface for meta-analysis, the D(M)FS pooled PF was 27% (95% confidence interval (CI), 23% to 30%; I2 = 42%) (moderate quality evidence). We found no significant association between estimates of D(M)FS prevented fractions and baseline caries severity, background exposure to fluorides, rinsing frequency or fluoride concentration in metaregression analyses. A funnel plot of the 35 studies in the D(M)FS PF meta-analysis indicated no relationship between prevented fraction and study precision (no evidence of reporting bias). The pooled estimate of D(M)FT PF was 23% (95% CI, 18% to 29%; I² = 54%), from the 13 trials that contributed data for the permanent teeth meta-analysis (moderate quality evidence).\nWe found limited information concerning possible adverse effects or acceptability of the treatment regimen in the included trials. Three trials incompletely reported data on tooth staining, and one trial incompletely reported information on mucosal irritation/allergic reaction. None of the trials reported on acute adverse symptoms during treatment.\nAuthors' conclusions\nThis review found that supervised regular use of fluoride mouthrinse by children and adolescents is associated with a large reduction in caries increment in permanent teeth. We are moderately certain of the size of the effect. Most of the evidence evaluated use of fluoride mouthrinse supervised in a school setting, but the findings may be applicable to children in other settings with supervised or unsupervised rinsing, although the size of the caries-preventive effect is less clear. Any future research on fluoride mouthrinses should focus on head-to-head comparisons between different fluoride rinse features or fluoride rinses against other preventive strategies, and should evaluate adverse effects and acceptability.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Regular use of fluoride mouthrinse under supervision results in a large reduction in tooth decay in children's permanent teeth. We found little information about potential adverse effects and acceptability."
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query-laysum | 4623 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevention of relapse is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations, are not effective for maintenance of remission and its chronic use is limited by numerous adverse events. Randomised controlled trials assessing the efficacy of oral 5-aminosalicylic acid (5-ASA) agents for maintenance of medically-induced remission in Crohn's disease have produced conflicting results.\nObjectives\nTo conduct a systematic review to evaluate the efficacy and safety of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL and the IBD Group Specialized Register from inception to 8 June 2016. We also searched reference lists and conference proceedings.\nSelection criteria\nWe included randomised controlled trials that compared oral 5-ASA agents to either placebo or sulphasalazine in patients with quiescent Crohn's disease. The trials had to have a treatment duration of at least six months.\nData collection and analysis\nTwo authors independently extracted data and performed the risk of bias assessment. Any disagreements were resolved by discussion and consensus. The primary outcome measure was the occurrence of relapse as defined by the primary studies. Secondary outcomes included time to relapse, adverse events, withdrawal due to adverse events and serious adverse events. We calculated the pooled risk ratio (RR) and corresponding 95% confidence interval (95% CI) using a fixed-effect model. All data were analysed on an intention-to-treat basis and drop-outs were considered to be relapses. Sensitivity analyses included an available case analysis where drop-outs were ignored and using a random-effects model. We evaluated the overall quality of the evidence supporting the outcomes using the GRADE criteria.\nMain results\nTwelve studies (2146 participants) that compared 5-ASA to placebo were included. We did not identify any studies that compared sulphasalazine to placebo. Seven studies were judged to be at low risk of bias. The other studies were judged to have an unclear risk of bias for various items due to insufficient details to allow for a judgement. There was no statistically significant difference in relapse rates at 12 months. Fifty-three per cent (526/998) of 5-ASA patients (dose 1.6 g to 4 g/day) relapsed at 12 months compared to 54% (544/1016) of placebo patients (RR 0.98, 95% CI 0.91 to 1.07; 11 studies; 2014 patients; moderate-quality evidence). Sensitivity analyses based on an available case analysis and a random-effects model had no impact on the results. One study found no difference in relapse rates at 24 months. Fifty-four per cent (31/57) of 5-ASA patients (dose 2 g/day) relapsed at 24 months compared to 58% (36/62) of placebo patients (RR 0.94, 95% CI 0.68 to 1.29, 119 patients; low-quality evidence). One paediatric study found no statistically significant difference in relapse rates at 12 months. Sixty-two per cent (29/47) of paediatric 5-ASA patients (dose 50 mg/kg/day) relapsed at 12 months compared to 64% (35/55) of paediatric placebo patients (RR 0.97, 95% CI 0.72 to 1.31; 102 patients; moderate-quality evidence). There was no statistically significant difference in the proportion of patients who experienced an adverse event, withdrawal due to adverse events or serious adverse events. Thirty-four per cent (307/900) of 5-ASA patients had at least one adverse event compared to 33% (301/914) of placebo patients (RR 1.05, 95% CI 0.95 to 1.17; 10 studies; 1814 patients). Fourteen per cent (127/917) of 5-ASA patients withdrew due to adverse events compared to 13% (119/916) of placebo patients (RR 1.11, 95% CI 0.88 to 1.38; 9 studies; 1833 patients). One per cent (3/293) of 5-ASA patients had a serious adverse event compared to 0.7% (2/283) of placebo patients (RR 1.43, 95% CI 0.24 to 2.83; 3 studies; 576 patients). Common adverse events reported in the studies included diarrhoea, nausea and vomiting, abdominal pain, headache and skin rash.\nAuthors' conclusions\nWe found no evidence in this review to suggest that oral 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease. Additional randomised trials may not be justified.\n\nGiven the provided abstract, please respond to the following query: \"What are 5-aminosalicylic acid (5-ASA) drugs?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "5-ASA drugs are a group of compounds that are thought to treat Crohn's disease by reducing inflammation in the gastrointestinal tract. These drugs are often taken orally (i.e. by mouth)."
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query-laysum | 4624 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease is the number one cause of death globally. According to the World Health Organization, 7.4 million people died from ischaemic heart diseases in 2012, constituting 15% of all deaths. Acute myocardial infarction is caused by blockage of the blood supplied to the heart muscle. Beta-blockers are often used in patients with acute myocardial infarction. Previous meta-analyses on the topic have shown conflicting results ranging from harms, neutral effects, to benefits. No previous systematic review using Cochrane methodology has assessed the effects of beta-blockers for acute myocardial infarction.\nObjectives\nTo assess the benefits and harms of beta-blockers compared with placebo or no intervention in people with suspected or diagnosed acute myocardial infarction.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded and BIOSIS Citation Index in June 2019. We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, Turning Research into Practice, Google Scholar, SciSearch, and the reference lists of included trials and previous reviews in August 2019.\nSelection criteria\nWe included all randomised clinical trials assessing the effects of beta-blockers versus placebo or no intervention in people with suspected or diagnosed acute myocardial infarction. Trials were included irrespective of trial design, setting, blinding, publication status, publication year, language, and reporting of our outcomes.\nData collection and analysis\nWe followed the Cochrane methodological recommendations. Four review authors independently extracted data. Our primary outcomes were all-cause mortality, serious adverse events according to the International Conference on Harmonization - Good Clinical Practice (ICH-GCP), and major adverse cardiovascular events (composite of cardiovascular mortality and non-fatal myocardial infarction during follow-up). Our secondary outcomes were quality of life, angina, cardiovascular mortality, and myocardial infarction during follow-up. Our primary time point of interest was less than three months after randomisation. We also assessed the outcomes at maximum follow-up beyond three months. Due to risk of multiplicity, we calculated a 97.5% confidence interval (CI) for the primary outcomes and a 98% CI for the secondary outcomes. We assessed the risks of systematic errors through seven bias domains in accordance to the instructions given in the Cochrane Handbook. The quality of the body of evidence was assessed by GRADE.\nMain results\nWe included 63 trials randomising a total of 85,550 participants (mean age 57.4 years). Only one trial was at low risk of bias. The remaining trials were at high risk of bias. The quality of the evidence according to GRADE ranged from very low to high. Fifty-six trials commenced beta-blockers during the acute phase of acute myocardial infarction and seven trials during the subacute phase.\nAt our primary time point 'less than three months follow-up', meta-analysis showed that beta-blockers versus placebo or no intervention probably reduce the risk of a reinfarction during follow-up (risk ratio (RR) 0.82, 98% confidence interval (CI) 0.73 to 0.91; 67,562 participants; 18 trials; moderate-quality evidence) with an absolute risk reduction of 0.5% and a number needed to treat for an additional beneficial outcome (NNTB) of 196 participants. However, we found little or no effect of beta-blockers when assessing all-cause mortality (RR 0.94, 97.5% CI 0.90 to 1.00; 80,452 participants; 46 trials/47 comparisons; high-quality evidence) with an absolute risk reduction of 0.4% and cardiovascular mortality (RR 0.99, 95% CI 0.91 to 1.08; 45,852 participants; 1 trial; moderate-quality evidence) with an absolute risk reduction of 0.4%. Regarding angina, it is uncertain whether beta-blockers have a beneficial or harmful effect (RR 0.70, 98% CI 0.25 to 1.84; 98 participants; 3 trials; very low-quality evidence) with an absolute risk reduction of 7.1%. None of the trials specifically assessed nor reported serious adverse events according to ICH-GCP. Only two trials specifically assessed major adverse cardiovascular events, however, no major adverse cardiovascular events occurred in either trial.\nAt maximum follow-up beyond three months, meta-analyses showed that beta-blockers versus placebo or no intervention probably reduce the risk of all-cause mortality (RR 0.93, 97.5% CI 0.86 to 0.99; 25,210 participants; 21 trials/22 comparisons; moderate-quality evidence) with an absolute risk reduction of 1.1% and a NNTB of 91 participants, and cardiovascular mortality (RR 0.90, 98% CI 0.83 to 0.98; 22,457 participants; 14 trials/15 comparisons; moderate-quality evidence) with an absolute risk reduction of 1.2% and a NNTB of 83 participants. However, it is uncertain whether beta-blockers have a beneficial or harmful effect when assessing major adverse cardiovascular events (RR 0.81, 97.5% CI 0.40 to 1.66; 475 participants; 4 trials; very low-quality evidence) with an absolute risk reduction of 1.7%; reinfarction (RR 0.89, 98% CI 0.75 to 1.08; 6825 participants; 14 trials; low-quality evidence) with an absolute risk reduction of 0.9%; and angina (RR 0.64, 98% CI 0.18 to 2.0; 844 participants; 2 trials; very low-quality evidence). None of the trials specifically assessed nor reported serious adverse events according to ICH-GCP.\nNone of the trials assessed quality of life.\nWe identified two ongoing randomised clinical trials investigating the effect of early administration of beta-blockers after percutaneous coronary intervention or thrombolysis to patients with an acute myocardial infarction and one ongoing trial investigating the effect of long-term beta-blocker therapy.\nAuthors' conclusions\nOur present review indicates that beta-blockers for suspected or diagnosed acute myocardial infarction probably reduce the short-term risk of a reinfarction and the long-term risk of all-cause mortality and cardiovascular mortality. Nevertheless, it is most likely that beta-blockers have little or no effect on the short-term risk of all-cause mortality and cardiovascular mortality. Regarding all remaining outcomes (serious adverse events according to ICH-GCP, major adverse cardiovascular events (composite of cardiovascular mortality and non-fatal myocardial infarction during follow-up), the long-term risk of a reinfarction during follow-up, quality of life, and angina), further information is needed to confirm or reject the clinical effects of beta-blockers on these outcomes for people with or suspected of acute myocardial infarction.\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 63 randomised clinical trials where people with or suspected of a heart attack were randomly allocated to receiving beta-blockers compared with placebo or no intervention. The 63 trials included 85,550 adults with a mean age of 57.4 years. Only one trial was at low risk of bias. The remaining trials were at high risk of bias. The quality of the evidence according to GRADE ranged from very low to high. Fifty-six trials commenced beta-blockers versus control during the acute phase of acute myocardial infarction and seven trials during the subacute phase."
}
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query-laysum | 4625 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is one of the most common childhood infectious diseases. Pain is the key symptom of AOM and central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management. This is an update of a review first published in 2016.\nObjectives\nOur primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs as compared with paracetamol in children with AOM.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 5, April 2023; MEDLINE (Ovid, from 1946 to May 2023), Embase (from 1947 to May 2023), CINAHL (from 1981 to May 2023), LILACS (from 1982 to May 2023), and Web of Science Core Collection (from 1955 to May 2023). We searched the WHO ICTRP and ClinicalTrials.gov for completed and ongoing trials (23 May 2023).\nSelection criteria\nWe included randomised controlled trials comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in non-hospitalised children aged six months to 16 years with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors. We extracted and summarised data for the following comparisons: paracetamol versus placebo, NSAIDs versus placebo, NSAIDs versus paracetamol, and NSAIDs plus paracetamol versus paracetamol alone.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We rated the overall certainty of evidence for each outcome of interest using the GRADE approach.\nMain results\nWe included four trials (411 children) which were assessed at low to high risk of bias.\nParacetamol versus placebo\nData from one trial (148 children) informed this comparison. Paracetamol may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 10% versus 25%, risk ratio (RR) 0.38, 95% confidence interval (CI) 0.17 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) 7; low-certainty evidence). The evidence is very uncertain about the effects of paracetamol on fever at 48 hours (RR 1.03, 95% CI 0.07 to 16.12; very low-certainty evidence) and adverse events (RR 1.03, 95% CI 0.21 to 4.93; very low-certainty evidence). No data were available for our other outcomes of interest.\nNSAIDs versus placebo\nData from one trial (146 children) informed this comparison. Ibuprofen may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 7% versus 25%, RR 0.28, 95% CI 0.11 to 0.70; NNTB 6; low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen on fever at 48 hours (RR 1.06, 95% CI 0.07 to 16.57; very low-certainty evidence) and adverse events (RR 1.76, 95% CI 0.44 to 7.10; very low-certainty evidence). No data were available for our other outcomes of interest.\nNSAIDs versus paracetamol\nData from four trials (411 children) informed this comparison. The evidence is very uncertain about the effect of ibuprofen versus paracetamol in relieving ear pain at 24 hours (RR 0.83, 95% CI 0.59 to 1.18; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 0.91, 95% CI 0.54 to 1.54; 3 RCTs, 183 children; low-certainty evidence); and four to seven days (RR 0.74, 95% CI 0.17 to 3.23; 2 RCTs, 38 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol on mean pain score at 24 hours (0.29 lower, 95% CI 0.79 lower to 0.20 higher; 3 RCTs, 111 children; very low-certainty evidence); 48 to 72 hours (0.25 lower, 95% CI 0.66 lower to 0.16 higher; 3 RCTs, 108 children; very low-certainty evidence); and four to seven days (0.30 higher, 95% CI 1.78 lower to 2.38 higher; 2 RCTs, 31 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol in resolving fever at 24 hours (RR 0.69, 95% CI 0.24 to 2.00; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 1.18, 95% CI 0.31 to 4.44; 3 RCTs, 182 children; low-certainty evidence); and four to seven days (RR 2.75, 95% CI 0.12 to 60.70; 2 RCTs, 39 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol on adverse events (RR 1.71, 95% CI 0.43 to 6.90; 3 RCTs, 281 children; very low-certainty evidence); reconsultations (RR 1.13, 95% CI 0.92 to 1.40; 1 RCT, 53 children; very low-certainty evidence); and delayed antibiotic prescriptions (RR 1.32, 95% CI 0.74 to 2.35; 1 RCT, 53 children; very low-certainty evidence).\nNo data were available on time to resolution of pain.\nNSAIDs plus paracetamol versus paracetamol alone\nData on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone came from two trials that provided crude subgroup data for 71 children with AOM. The small sample provided imprecise effect estimates, therefore we were unable to draw any firm conclusions (very low-certainty evidence).\nAuthors' conclusions\nDespite explicit guideline recommendations on the use of analgesics in children with AOM, the current evidence on the effectiveness of paracetamol or NSAIDs, alone or combined, in children with AOM is limited. Paracetamol and ibuprofen as monotherapies may be more effective than placebo in relieving short-term ear pain in children with AOM. The evidence is very uncertain for the effect of ibuprofen versus paracetamol on relieving short-term ear pain in children with AOM, as well as for the effectiveness of ibuprofen plus paracetamol versus paracetamol alone, thereby preventing any firm conclusions. Further research is needed to provide insights into the role of ibuprofen as adjunct to paracetamol, and other analgesics such as anaesthetic eardrops, for children with AOM.\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 if painkillers are effective for relieving ear pain in children with AOM and which drugs, alone or together, provide the most effective pain relief."
}
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query-laysum | 4626 | [
{
"role": "user",
"content": "Abstract: Background\nLaparoscopic cholecystectomy (key-hole removal of the gallbladder) is now the most often used method for treatment of symptomatic gallstones. Several cardiopulmonary changes (decreased cardiac output, pulmonary compliance, and increased peak airway pressure) occur during pneumoperitoneum, which is now introduced to allow laparoscopic cholecystectomy. These cardiopulmonary changes may not be tolerated in individuals with poor cardiopulmonary reserve.\nObjectives\nTo assess the benefits and harms of abdominal wall lift compared to pneumoperitoneum in patients undergoing laparoscopic cholecystectomy.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013.\nSelection criteria\nWe included all randomised clinical trials comparing abdominal wall lift (with or without pneumoperitoneum) versus pneumoperitoneum.\nData collection and analysis\nWe calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis with both the fixed-effect and the random-effects models using the Review Manager (RevMan) software.\nMain results\nFor abdominal wall lift with pneumoperitoneum versus pneumoperitoneum, a total of 130 participants (all with low anaesthetic risk) scheduled for elective laparoscopic cholecystectomy were randomised in five trials to abdominal wall lift with pneumoperitoneum (n = 53) versus pneumoperitoneum only (n = 52). One trial which included 25 people did not state the number of participants in each group. All five trials had a high risk of bias. There was no mortality or conversion to open cholecystectomy in any of the participants in the trials that reported these outcomes. There was no significant difference in the rate of serious adverse events between the two groups (two trials; 2/29 events (0.069 events per person) versus 2/29 events (0.069 events per person); rate ratio 1.00; 95% CI 0.17 to 5.77). None of the trials reported quality of life, the proportion of people discharged as day-patient laparoscopic cholecystectomies, or pain between four and eight hours after the operation. There was no significant difference in the operating time between the two groups (four trials; 53 participants versus 54 participants; 13.39 minutes longer (95% CI 2.73 less to 29.51 minutes longer) in the abdominal wall lift with pneumoperitoneum group and 100 minutes in the pneumoperitoneum group).\nFor abdominal wall lift versus pneumoperitoneum, a total of 774 participants (the majority with low anaesthetic risk) scheduled for elective laparoscopic cholecystectomy were randomised in 18 trials to abdominal wall lift without pneumoperitoneum (n = 332) versus pneumoperitoneum (n = 358). One trial which included 84 people did not state the number in each group. All the trials had a high risk of bias. There was no mortality in any of the trials that reported this outcome. There was no significant difference in the proportion of participants with serious adverse events (six trials; 5/172 (weighted proportion 2.4%) versus 2/171 (1.2%); RR 2.01; 95% CI 0.52 to 7.80). There was no significant difference in the rate of serious adverse events between the two groups (three trials; 5/99 events (weighted number of events per person = 0.346 events) versus 2/99 events (0.020 events per person); rate ratio 1.73; 95% CI 0.35 to 8.61). None of the trials reported quality of life or pain between four and eight hours after the operation. There was no significant difference in the proportion of people who underwent conversion to open cholecystectomy (11 trials; 5/225 (weighted proportion 2.3%) versus 7/235 (3.0%); RR 0.76; 95% CI 0.26 to 2.21). The operating time was significantly longer in the abdominal wall lift group than in the pneumoperitoneum group (16 trials; 6.87 minutes longer (95% CI 4.74 minutes to 9.00 minutes longer) in the abdominal wall lift group versus 75 minutes in the pneumoperitoneum group). There was no significant difference in the proportion of people discharged as laparoscopic cholecystectomy day-patients (two trials; 15/31 (weighted proportion 48.5%) versus 9/31 (29%); RR 1.67; 95% CI 0.85 to 3.26).\nAuthors' conclusions\nAbdominal wall lift with or without pneumoperitoneum does not seem to offer an advantage over pneumoperitoneum in any of the patient-oriented outcomes for laparoscopic cholecystectomy in people with low anaesthetic risk. Hence it cannot be recommended routinely. The safety of abdominal wall lift is yet to be established. More research on the topic is needed because of the risk of bias in the included trials and because of the risk of type I and type II random errors due to the few participants included in the trials. Future trials should include people at higher anaesthetic risk. Furthermore, such trials should include blinded assessment of outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Abdominal wall lift with pneumoperitoneum versus pneumoperitoneum\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A total of 130 participants (all with low anaesthetic risk) were included in five trials which compared abdominal wall lift combined with very low pressure pneumoperitoneum and standard pneumoperitoneum. All five trials had a high risk of bias (introducing the possibility of overestimating benefits or underestimating the harms of abdominal wall lift). No-one died as a result of surgery. There was no significant difference in the rate of serious complications related to the surgery. None of the trials reported quality of life, the proportion of people discharged as laparoscopic cholecystectomy day-patients, or pain between four and eight hours after the operation. None required conversion of key-hole surgery to an open operation using a larger incision. There was no significant difference in the operating time between the two groups."
}
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query-laysum | 4627 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects.\nObjectives\n• To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia\n• To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety\n• To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification).\nSelection criteria\nRandomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded.\nData collection and analysis\nA review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo.\nMain results\nWe included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%).\nIn this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies).\nAlmost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome.\nAltogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias.\nVomiting within 24 hours postoperatively\nRelative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28).\nRecommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available).\nFrequency of SAEs\nTwenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant.\nFrequency of any AE\nSixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant.\nClass-specific side effects\nFor class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant.\nDirection and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353.\nAuthors' conclusions\nWe found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects.\nRecommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron.\nThe results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).\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 looked at the use of antiemetic medicines in adults having general anaesthesia to prevent people from being sick afterwards.\nWe looked for randomized controlled studies, in which the treatments people received were decided at random. This type of study usually gives the most reliable evidence about the effects of a treatment."
}
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query-laysum | 4628 | [
{
"role": "user",
"content": "Abstract: Background\nBenign smooth muscle tumours of the uterus, known as fibroids or myomas, are often symptomless. However, about one-third of women with fibroids will present with symptoms that are severe enough to warrant treatment. The standard treatment of symptomatic fibroids is hysterectomy (that is surgical removal of the uterus) for women who have completed childbearing, and myomectomy for women who desire future childbearing or simply want to preserve their uterus. Myomectomy, the surgical removal of myomas, can be associated with life-threatening bleeding. Excessive bleeding can necessitate emergency blood transfusion. Knowledge of the effectiveness of the interventions to reduce bleeding during myomectomy is essential to enable evidence-based clinical decisions. This is an update of the review published in The Cochrane Library (2011, Issue 11).\nObjectives\nTo assess the effectiveness, safety, tolerability and costs of interventions to reduce blood loss during myomectomy.\nSearch methods\nIn June 2014, we conducted electronic searches in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO, and trial registers for ongoing and registered trials.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that compared potential interventions to reduce blood loss during myomectomy to placebo or no treatment.\nData collection and analysis\nThe two authors independently selected RCTs for inclusion, assessed the risk of bias and extracted data from the included RCTs. The primary review outcomes were blood loss and need for blood transfusion. We expressed study results as mean differences (MD) for continuous data and odds ratios for dichotomous data, with 95% confidence intervals (CI). We assessed the quality of evidence using GRADE methods.\nMain results\nEighteen RCTs with 1250 participants met our inclusion criteria. The studies were conducted in hospital settings in low, middle and high income countries.\nBlood loss\nWe found significant reductions in blood loss with the following interventions:\nvaginal misoprostol (2 RCTs, 89 women: MD -97.88 ml, 95% CI -125.52 to -70.24; I2 = 43%; moderate-quality evidence); intramyometrial vasopressin (3 RCTs, 128 women: MD -245.87 ml, 95% CI -434.58 to -57.16; I2 = 98%; moderate-quality evidence); intramyometrial bupivacaine plus epinephrine (1 RCT, 60 women: MD -68.60 ml, 95% CI -93.69 to -43.51; low-quality evidence); intravenous tranexamic acid (1 RCT, 100 women: MD -243 ml, 95% CI -460.02 to -25.98; low-quality evidence); gelatin-thrombin matrix (1 RCT, 50 women: MD -545.00 ml, 95% CI -593.26 to -496.74; low-quality evidence); intravenous ascorbic acid (1 RCT, 102 women: MD -411.46 ml, 95% CI -502.58 to -320.34; low-quality evidence); vaginal dinoprostone (1 RCT, 108 women: MD -131.60 ml, 95% CI -253.42 to -9.78; low-quality evidence); loop ligation of the myoma pseudocapsule (1 RCT, 70 women: MD -305.01 ml, 95% CI -354.83 to -255.19; low-quality evidence); a fibrin sealant patch (1 RCT, 70 women: MD -26.50 ml, 95% CI -44.47 to -8.53; low-quality evidence), a Foley catheter tied around the cervix (1 RCT, 93 women: MD -240.70 ml, 95% CI -359.61 to -121.79; low-quality evidence), and a polyglactin suture round both cervix and infundibulopelvic ligament (1 RCT, 28 women: MD -1870.0 ml, 95% CI -2547.16 to 1192.84; low-quality evidence). There was no good evidence of an effect on blood loss with oxytocin, morcellation or clipping of the uterine artery.\nNeed for blood transfusion\nWe found significant reductions in the need for blood transfusion with vasopressin (2 RCTs, 90 women: OR 0.15, 95% CI 0.03 to 0.74; I2 = 0%; moderate-quality evidence); tourniquet tied round the cervix (1 RCT, 98 women: OR 0.22, 95% CI 0.09 to 0.55; low-quality evidence); tourniquet tied round both cervix and infundibulopelvic ligament (1 RCT, 28 women: OR 0.02, 95% CI 0.00 to 0.23; low-quality evidence); gelatin-thrombin matrix (1 RCT, 100 women: OR 0.01, 95% CI 0.00 to 0.10; low-quality evidence) and dinoprostone (1 RCT, 108 women: OR 0.17, 95% CI 0.04 to 0.81; low-quality evidence), but no evidence of effect on the need for blood transfusion with misoprostol, oxytocin, tranexamic acid, ascorbic acid, loop ligation of the myoma pseudocapsule and a fibrin sealant patch.\nThere were insufficient data on the adverse effects and costs of the different interventions.\nAuthors' conclusions\nAt present there is moderate-quality evidence that misoprostol or vasopressin may reduce bleeding during myomectomy, and low-quality evidence that bupivacaine plus epinephrine, tranexamic acid, gelatin-thrombin matrix, ascorbic acid, dinoprostone, loop ligation, a fibrin sealant patch, a peri-cervical tourniquet or a tourniquet tied round both cervix and infundibulopelvic ligament may reduce bleeding during myomectomy. There is no evidence that oxytocin, morcellation and temporary clipping of the uterine artery reduce blood loss. Further well designed studies are required to establish the effectiveness, safety and costs of different interventions for reducing blood loss during myomectomy.\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": "The evidence is current to June 2014. The review included 18 studies with a total of 1250 women who had myomectomy for uterine fibroids. All studies compared an intervention to reduce bleeding during myomectomy with either a placebo or no such treatment."
}
]
|
query-laysum | 4629 | [
{
"role": "user",
"content": "Abstract: Background\nRisperidone is the first new-generation antipsychotic drug made available in the market in its generic form.\nObjectives\nTo determine the clinical effects, safety and cost-effectiveness of risperidone compared with placebo for treating schizophrenia.\nSearch methods\nOn 19th October 2015, we searched the Cochrane Schizophrenia Group Trials Register, which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We checked the references of all included studies and contacted industry and authors of included studies for relevant studies and data.\nSelection criteria\nRandomised clinical trials (RCTs) comparing oral risperidone with placebo treatments for people with schizophrenia and/or schizophrenia-like psychoses.\nData collection and analysis\nTwo review authors independently screened studies, assessed the risk of bias of included studies and extracted data. For dichotomous data, we calculated the risk ratio (RR), and the 95% confidence interval (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and the 95% CI. We created a 'Summary of findings table' using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nThe review includes 15 studies (N = 2428). Risk of selection bias is unclear in most of the studies, especially concerning allocation concealment. Other areas of risk such as missing data and selective reporting also caused some concern, although not affected on the direction of effect of our primary outcome, as demonstrated by sensitivity analysis. Many of the included trials have industry sponsorship of involvement. Nonetheless, generally people in the risperidone group are more likely to achieve a significant clinical improvement in mental state (6 RCTs, N = 864, RR 0.64, CI 0.52 to 0.78, very low-quality evidence). The effect withstood, even when three studies with >50% attrition rate were removed from the analysis (3 RCTs, N = 589, RR 0.77, CI 0.67 to 0.88). Participants receiving placebo were less likely to have a clinically significant improvement on Clinical Global Impression scale (CGI) than those receiving risperidone (4 RCTs, N = 594, RR 0.69, CI 0.57 to 0.83, very low-quality evidence). Overall, the risperidone group was 31% less likely to leave early compared to placebo group (12 RCTs, N = 2261, RR 0.69, 95% CI 0.62 to 0.78, low-quality evidence), but Incidence of significant extrapyramidal side effect was more likely to occur in the risperidone group (7 RCTs, N = 1511, RR 1.56, 95% CI 1.13 to 2.15, very low-quality evidence).\nWhen risperidone and placebo were augmented with clozapine, there is no significant differences between groups for clinical response as defined by a less than 20% reduction in PANSS/BPRS scores (2 RCTs, N = 98, RR 1.15, 95% CI 0.93 to 1.42, low-quality evidence) and attrition (leaving the study early for any reason) (3 RCTs, N = 167, RR 1.13, 95% CI 0.53 to 2.42, low quality evidence). One study measured clinically significant responses using the CGI, no effect was evident (1 RCT, N = 68, RR 1.12 95% CI 0.87 to 1.44, low quality evidence). No data were available for extrapyramidal adverse effects.\nAuthors' conclusions\nBased on low quality evidence, risperidone appears to be benefitial in improving mental state compared with placebo, but it also causes more adverse events. Eight out of the 15 included trials were funded by pharmaceutical companies. The currently available evidence isvery low to low quality.\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": "Searches for high-quality randomised trials were carried out in 2008, 2013 and 2015. The review now includes 15 studies with 2428 participants. The studies randomised participants (in- and outpatients) with schizophrenia or schizophrenia-like illnesses into treatment groups that received oral risperidone or placebo."
}
]
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query-laysum | 4630 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacotherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication when used as an add-on treatment for drug-resistant epilepsy. In January 2009, rufinamide was approved by the US Food and Drug Administration for the treatment of children four years of age and older with Lennox-Gastaut syndrome. It is also approved as an add-on treatment for adults and adolescents with focal seizures.\nThis is an updated version of the original Cochrane Review published in 2018.\nObjectives\nTo evaluate the efficacy and tolerability of rufinamide when used as an add-on treatment for people with drug-resistant epilepsy.\nSearch methods\nWe imposed no language restrictions. We contacted the manufacturers of rufinamide and authors in the field to identify any relevant unpublished studies.\nSelection criteria\nRandomised, double-blind, placebo-controlled, add-on trials of rufinamide, recruiting people (of any age or gender) with drug-resistant epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 50% or greater reduction in seizure frequency (primary outcome); seizure freedom; treatment withdrawal; and adverse effects (secondary outcomes). Primary analyses were intention-to-treat (ITT) and we presented summary risk ratios (RRs) 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\nThe review included six trials, representing 1759 participants. Four trials (1563 participants) included people with uncontrolled focal seizures. Two trials (196 participants) included individuals with established Lennox-Gastaut syndrome. Overall, the age of adults ranged from 18 to 80 years and the age of children ranged from 4 to 16 years. Baseline phases ranged from 28 to 56 days and double-blind phases from 84 to 96 days. Five of the six included trials described adequate methods of concealment of randomisation, and only three described adequate blinding. All analyses were by ITT. Overall, five studies were at low risk of bias and one had unclear risk of bias due to lack of reported information around study design. All trials were sponsored by the manufacturer of rufinamide and therefore were at high risk of funding bias.\nThe overall RR for 50% or greater reduction in seizure frequency was 1.79 (95% CI 1.44 to 2.22; 6 randomised controlled trials (RCTs), 1759 participants; moderate-certainty evidence), indicating that rufinamide (plus conventional AED) was significantly more effective than placebo (plus conventional AED) in reducing seizure frequency by at least 50% when added to conventionally used AEDs in people with drug-resistant focal epilepsy. Data from only one study (73 participants) reported seizure freedom: RR 1.32 (95% CI 0.36 to 4.86; 1 RCT, 73 participants; moderate-certainty evidence). The overall RR for treatment withdrawal (for any reason and due to AED) was 1.83 (95% CI 1.45 to 2.31; 6 RCTs, 1759 participants; moderate-certainty evidence), showing that rufinamide was significantly more likely to be withdrawn than placebo. Most adverse effects were significantly more likely to occur in the rufinamide-treated group. Adverse events significantly associated with rufinamide were headache, dizziness, somnolence, vomiting, nausea, fatigue, and diplopia. The RRs for these adverse effects were as follows: headache 1.36 (95% Cl 1.08 to 1.69; 3 RCTs, 1228 participants; high-certainty evidence); dizziness 2.52 (95% Cl 1.90 to 3.34; 3 RCTs, 1295 participants; moderate-certainty evidence); somnolence 1.94 (95% Cl 1.44 to 2.61; 6 RCTs, 1759 participants; moderate-certainty evidence); vomiting 2.95 (95% Cl 1.80 to 4.82; 4 RCTs, 777 participants; low-certainty evidence); nausea 1.87 (95% Cl 1.33 to 2.64; 3 RCTs, 1295 participants; moderate-certainty evidence); fatigue 1.46 (95% Cl 1.08 to 1.97; 3 RCTs, 1295 participants; moderate-certainty evidence); and diplopia 4.60 (95% Cl 2.53 to 8.38; 3 RCTs, 1295 participants; low-certainty evidence). There was no important heterogeneity between studies for any outcomes. Overall, we assessed the evidence as moderate to low certainty due to wide CIs and potential risk of bias from some studies contributing to the analysis.\nAuthors' conclusions\nFor people with drug-resistant focal epilepsy, rufinamide when used as an add-on treatment was effective in reducing seizure frequency. However, the trials reviewed were of relatively short duration and provided no evidence for long-term use of rufinamide. In the short term, rufinamide as an add-on was associated with several adverse events. This review focused on the use of rufinamide 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 rufinamide when used as monotherapy.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are moderately confident (certain) about our findings for the effects of add-on rufinamide on how many seizures people had, and on some of the unwanted effects seen (dizziness, sleepiness, headaches, tiredness and feeling sick). Our results may change if further evidence becomes available.\nWe are less confident (uncertain) about the unwanted effects of vomiting and double vision seen with add-on rufinamide, because the results for these effects varied widely. Our results are likely to change if further evidence becomes available.\nAll studies were conducted or sponsored by a pharmaceutical company that makes rufinamide: this may have affected how the studies were designed, carried out and reported. One study did not fully report its study design."
}
]
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query-laysum | 4631 | [
{
"role": "user",
"content": "Abstract: Background\nVentilator-associated pneumonia (VAP) is common in intensive care units (ICUs). Some evidence indicates that probiotics may reduce the incidence of VAP. Several additional published studies have demonstrated that probiotics are safe and efficacious in preventing VAP in ICUs. We aimed to systematically summarise the results of all available data to generate the best evidence for the prevention of VAP.\nObjectives\nTo evaluate the effectiveness and safety of probiotics for preventing VAP.\nSearch methods\nWe searched CENTRAL (2014, Issue 8), MEDLINE (1948 to September week 1, 2014) and EMBASE (2010 to September 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing probiotics with placebo or another control (excluding RCTs that use probiotics in both study groups) to prevent VAP.\nData collection and analysis\nTwo review authors independently assessed eligibility and the quality of trials, and extracted data.\nMain results\nWe included eight RCTs, with 1083 participants. All studies compared a form of probiotic (Lactobacillus casei rhamnosus; Lactobacillus plantarum; Synbiotic 2000FORTE; Ergyphilus; combination Bifidobacterium longum + Lactobacillus bulgaricus + Streptococcus thermophilus) versus a control group (placebo; glutamine; fermentable fibre; peptide; chlorhexidine). The analysis of all RCTs showed that the use of probiotics decreased the incidence of VAP (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.52 to 0.95, low quality evidence). However, the aggregated results were uncertain for ICU mortality (OR 0.84, 95% CI 0.58 to 1.22 very low quality evidence), in-hospital mortality (OR 0.78, 95% CI 0.54 to 1.14, very low quality evidence), incidence of diarrhoea (OR 0.72, 95% CI 0.47 to 1.09, very low quality evidence), length of ICU stay (mean difference (MD) -1.60, 95% CI -6.53 to 3.33, very low quality evidence), duration of mechanical ventilation (MD -6.15, 95% CI -18.77 to 6.47, very low quality evidence) and antibiotic use (OR 1.23, 95% CI 0.51 to 2.96, low quality evidence). Antibiotics for VAP were used for a shorter duration (in days) when participants received probiotics in one small study (MD -3.00, 95% CI -6.04 to 0.04). However, the CI of the estimated effect was too wide to exclude no difference with probiotics. There were no reported events of nosocomial probiotic infections in any included study.\nThe overall methodological quality of the included studies, based on our 'Risk of bias' assessments, was moderate with half of the included studies rated as a 'low' risk of bias; however, we rated four included studies as a 'high' risk of bias across one or more of the domains. The study limitations, differences in probiotics administered and participants, and small sample sizes across the included studies mean that the power to detect a trend of overall effect may be limited and chance findings cannot be excluded.\nTo explore the influence of some potential confounding factors in the studies, we conducted an intention-to-treat (ITT) analysis, which did not change the inference of per-protocol analysis. However, our sensitivity analysis did not indicate a significant difference between groups for instances of VAP.\nAuthors' conclusions\nEvidence suggests that use of probiotics is associated with a reduction in the incidence of VAP. However, the quality of the evidence is low and the exclusion of the one study that did not provide a robust definition of VAP increased the uncertainty in this finding. The available evidence is not clear regarding a decrease in ICU or hospital mortality with probiotic use. Three trials reported on the incidence of diarrhoea and the pooled results indicate no clear evidence of a difference. The results of this meta-analysis do not provide sufficient evidence to draw conclusions on the efficacy and safety of probiotics for the prevention of VAP in ICU patients.\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 critically assess the current evidence from published studies relating to the effect of probiotics for preventing ventilator-associated pneumonia (VAP)."
}
]
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query-laysum | 4632 | [
{
"role": "user",
"content": "Abstract: Background\nEnteral nutrition by feeding tube is a common and efficient method of providing nutritional support to prevent malnutrition in hospitalised patients who have adequate gastrointestinal function but who are unable to eat. Gastric feeding may be associated with higher rates of food aspiration and pneumonia than post-pyloric naso-enteral tubes. Thus, enteral feeding tubes are placed directly into the small intestine rather than the stomach, and the use of metoclopramide, a prokinetic agent, has been recommended to achieve post-pyloric placement, but its efficacy is controversial. Moreover, metoclopramide may include adverse reactions, which with high doses or prolonged use may be serious and irreversible.\nObjectives\nTo determine the effect of intravenous metoclopramide on post-pyloric placement of the naso-enteral tube in adults.\nSearch methods\nTrials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10) which includes the CUGPD group's specialised register of trials, MEDLINE (1996 to 21 October 2014), EMBASE (1988 to 21 October 2014), LILACS (2005 to 21 October 2014) We did not confine our search to English language publications. Searches in all databases were updated originally in January 2005, then in November 2008 and again in October 2014. No new studies were found in 2008 or in 2014.\nSelection criteria\nWe selected randomised controlled trials of adults needing enteral nutrition, who received intravenous or intramuscular metoclopramide to aid placement of transpyloric naso-enteral feeding tubes, compared to placebo or no intervention.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. All analyses were performed according to the intention-to-treat method. We present risk ratios (RR) with 95% confidence intervals (CI).\nMain results\nFour studies, with a total of 204 participants were included and analysed. The trials compared metoclopramide with placebo (two trials) or with no intervention (two trials). Metoclopramide was investigated at doses of 10 mg (two trials) and 20 mg (two trials). There was no statistically significant difference between metoclopramide versus placebo or no intervention administered to promote tube placement (RR 0.82, 95% CI 0.61 to 1.10). Metoclopramide at doses of 10 mg (RR 0.82, 95% CI 0.60 to 1.11) and 20 mg (RR 0.62, 95% CI 0.15 to 2.62) were equally ineffective in facilitating post-pyloric intubation when compared with placebo or no intervention.\nAuthors' conclusions\nIn this review, we found only four studies that fitted our inclusion criteria. These were small, underpowered studies, in which metoclopramide was given at doses of 10 mg and 20 mg. Our analysis showed that metoclopramide did not assist post-pyloric placement of naso-enteral feeding tubes.\nIdeally randomised clinical trials should be performed that have a significant sample size, administering metoclopramide against control, however, given the lack of efficacy revealed by this review it is unlikely that further studies will be performed.\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 originally searched for clinical trials in 2002; and again in 2008 and 2014. We identified four studies that investigated the use of metoclopramide in placement of post-pyloric naso-enteral feeding tubes. The trials included a total of 204 adult participants; 108 participants were treated with metoclopramide, and 96 were given a placebo or no treatment. All four studies were done in hospitals in the USA. The number of participants included in the trials varied from 105 to 10.\nThe trials were all performed before 1995. They were all small, and examined two different doses of metoclopramide (10 mg and 20 mg), delivered in two different ways (intravenously, and injected into muscle). The way in which they were conducted and reported was poor."
}
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query-laysum | 4633 | [
{
"role": "user",
"content": "Abstract: Background\nSupplementary oxygen is routinely administered to low-risk pregnant women during an elective caesarean section under regional anaesthesia; however, maternal and foetal outcomes have not been well established. This is an update of a review first published in 2013.\nObjectives\nThe primary objective was to determine whether supplementary oxygen given to low-risk term pregnant women undergoing elective caesarean section under regional anaesthesia can prevent maternal and neonatal desaturation. The secondary objective was to compare the mean values of maternal and neonatal blood gas levels between mothers who received supplementary oxygen and those who did not (control group).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, issue 11), MEDLINE (1948 to November 2014) and EMBASE (1980 to November 2014). The original search was first performed in February 2012. We reran the search in CENTRAL, MEDLINE, EMBASE in February 2016. One potential new study of interest was added to the list of ‘Studies awaiting Classification' and will be incorporated into the formal review findings during the next review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) of low-risk pregnant women undergoing an elective caesarean section under regional anaesthesia and compared outcomes with, and without, oxygen supplementation.\nData collection and analysis\nTwo review authors independently extracted data, assessed methodological quality and performed subgroup and sensitivity analyses.\nMain results\nWe found one new included study in this updated version. In total, our updated review includes 11 trials (with 753 participants). The low quality of evidence showed no significant differences in average Apgar scores at one minute (N = six trials, 519 participants; 95% confidence (CI) -0.16 to 0.31, P = 0.53) and at five minutes (N = six trials, 519 participants; 95% CI -0.06 to 0.06, P = 0.98). None of the 11 trials reported maternal desaturation. The very low quality of evidence showed that in comparison to room air, women in labour receiving supplementary oxygen had higher maternal oxygen saturation (N = three trials, 209 participants), maternal PaO2 (oxygen pressure in the blood; N = six trials, 241 participants), UaPO2 (foetal umbilical arterial blood; N = eight trials, 504 participants; 95% CI 1.8 to 4.9, P < 0.0001) and UvPO2 (foetal umbilical venous blood; N = 10 trials, 683 participants). There was high heterogeneity among these outcomes. A subgroup analysis showed no significant difference in UaPO2 between the two intervention groups in low-risk studies, whereas the high-risk studies showed a benefit for the neonatal oxygen group.\nAuthors' conclusions\nOverall, we found no convincing evidence that giving supplementary oxygen to healthy term pregnant women during elective caesarean section under regional anaesthesia is either beneficial or harmful for either the mother or the foetus' short-term clinical outcome as assessed by Apgar scores. Although, there were significant higher maternal and neonatal blood gas values and markers of free radicals when extra oxygen was given, the results should be interpreted with caution due to the low grade quality of the evidence.\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 updated Cochrane review included 11 studies involving 753 participants. The studies compared maternal (mother) and neonatal (foetal) outcomes when pregnant women received extra oxygen versus room air. Oxygen was given to the women in different ways (at any flow rate or concentration via any oxygen delivery device)."
}
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query-laysum | 4634 | [
{
"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: \"How is the severity of OSA estimated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The severity of OSA is measured using a scale called Apnoea-Hypopnea Index (AHI). AHI refers to number of times the breathing stops or becomes shallower per hour of sleep. AHI is measured by using a study done in sleep known as polysomnography.\nThe severity of OSA can be measured indirectly using a questionnaire called Epworth Sleepiness Scale (ESS). This assesses how sleepy a person is during the day."
}
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query-laysum | 4635 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with asthma who come from minority groups often have poorer asthma outcomes, including more acute asthma-related doctor visits for flare-ups. Various programmes used to educate and empower people with asthma have previously been shown to improve certain asthma outcomes (e.g. adherence outcomes, asthma knowledge scores in children and parents, and cost-effectiveness). Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual, and not just the symptoms of the disease. Therefore, questions about whether tailoring asthma education programmes that are culturally specific for people from minority groups are effective at improving asthma-related outcomes, that are feasible and cost-effective need to be answered.\nObjectives\nTo determine whether culture-specific asthma education programmes, in comparison to generic asthma education programmes or usual care, improve asthma-related outcomes in children and adults with asthma who belong to minority groups.\nSearch methods\nWe searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, Embase, review articles and reference lists of relevant articles. The latest search fully incorporated into the review was performed in June 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups with asthma.\nData collection and analysis\nTwo review authors independently selected, extracted and assessed the data for inclusion. We contacted study authors for further information if required.\nMain results\nIn this review update, an additional three studies and 220 participants were added. A total of seven RCTs (two in adults, four in children, one in both children and adults) with 837 participants (aged from one to 63 years) with asthma from ethnic minority groups were eligible for inclusion in this review. The methodological quality of studies ranged from very low to low. For our primary outcome (asthma exacerbations during follow-up), the quality of evidence was low for all outcomes. In adults, use of a culture-specific programme, compared to generic programmes or usual care did not significantly reduce the number of participants from two studies with 294 participants for: exacerbations with one or more exacerbations during follow-up (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.50 to 1.26), hospitalisations over 12 months (OR 0.83, 95% CI 0.31 to 2.22) and exacerbations requiring oral corticosteroids (OR 0.97, 95% CI 0.55 to 1.73). However, use of a culture-specific programme, improved asthma quality of life scores in 280 adults from two studies (mean difference (MD) 0.26, 95% CI 0.17 to 0.36) (although the MD was less then the minimal important difference for the score). In children, use of a culture-specific programme was superior to generic programmes or usual care in reducing severe asthma exacerbations requiring hospitalisation in two studies with 305 children (rate ratio 0.48, 95% CI 0.24 to 0.95), asthma control in one study with 62 children and QoL in three studies with 213 children, but not for the number of exacerbations during follow-up (OR 1.55, 95% CI 0.66 to 3.66) or the number of exacerbations (MD 0.18, 95% CI -0.25 to 0.62) among 100 children from two studies.\nAuthors' conclusions\nThe available evidence showed that culture-specific education programmes for adults and children from minority groups are likely effective in improving asthma-related outcomes. This review was limited by few studies and evidence of very low to low quality. Not all asthma-related outcomes improved with culture-specific programs for both adults and children. Nevertheless, while modified culture-specific education programs are usually more time intensive, the findings of this review suggest using culture-specific asthma education programmes for children and adults from minority groups. However, more robust RCTs are needed to further strengthen the quality of evidence and determine the cost-effectiveness of culture-specific programs.\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": "People with asthma who come from minority groups have poorer asthma outcomes. Asthma education that is culturally specific may improve asthma-related outcomes."
}
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query-laysum | 4636 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of nonalcohol-related fatty liver disease (NAFLD) varies between 19% and 33% in different populations. NAFLD decreases life expectancy and increases the risks of liver cirrhosis, hepatocellular carcinoma, and requirement for liver transplantation. There is uncertainty surrounding the relative benefits and harms of various lifestyle interventions for people with NAFLD.\nObjectives\nTo assess the comparative benefits and harms of different lifestyle interventions in the treatment of NAFLD through a network meta-analysis, and to generate rankings of the different lifestyle interventions according to their safety and efficacy.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, World Health Organization International Clinical Trials Registry Platform, and trials registers until February 2021 to identify randomised clinical trials in people with NAFLD.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or status) in people with NAFLD, whatever the method of diagnosis, age, and diabetic status of participants, or presence of non-alcoholic steatohepatitis (NASH). We excluded randomised clinical trials in which participants had previously undergone liver transplantation.\nData collection and analysis\nWe planned to perform a network meta-analysis with OpenBUGS using Bayesian methods and to calculate the differences in treatments using hazard ratios (HRs), odds ratios (ORs), and rate ratios (RaRs) with 95% credible intervals (CrIs) based on an available-participant analysis, according to National Institute of Health and Care Excellence Decision Support Unit guidance. However, the data were too sparse for the clinical outcomes. We therefore performed only direct comparisons (head-to-head comparisons) with OpenBUGS using Bayesian methods.\nMain results\nWe included a total of 59 randomised clinical trials (3631 participants) in the review. All but two trials were at high risk of bias. A total of 33 different interventions, ranging from advice to supervised exercise and special diets, or a combination of these and no additional intervention were compared in these trials. The reference treatment was no active intervention. Twenty-eight trials (1942 participants) were included in one or more comparisons. The follow-up ranged from 1 month to 24 months. The remaining trials did not report any of the outcomes of interest for this review.\nThe follow-up period in the trials that reported clinical outcomes was 2 months to 24 months. During this short follow-up period, clinical events related to NAFLD such as mortality, liver cirrhosis, liver decompensation, liver transplantation, hepatocellular carcinoma, and liver-related mortality were sparse. This is probably because of the very short follow-up periods. It takes a follow-up of 8 years to 28 years to detect differences in mortality between people with NAFLD and the general population. It is therefore unlikely that differences by clinical outcomes will be noted in trials with less than 5 years to 10 years of follow-up.\nIn one trial, one participant developed an adverse event. There were no adverse events in any of the remaining participants in this trial, or in any of the remaining trials, which seemed to be directly related to the intervention.\nAuthors' conclusions\nThe evidence indicates considerable uncertainty about the effects of the lifestyle interventions compared with no additional intervention (to general public health advice) on any of the clinical outcomes after a short follow-up period of 2 months to 24 months in people with nonalcohol-related fatty liver disease.\nAccordingly, high-quality randomised clinical trials with adequate follow-up are needed. We propose registry-based randomised clinical trials or cohort multiple randomised clinical trials (a study design in which multiple interventions are trialed within large longitudinal cohorts of participants to gain efficiencies and align trials more closely to standard clinical practice), comparing aerobic exercise and dietary advice versus standard of care (exercise and dietary advice received as part of national health promotion). The reason for the choice of aerobic exercise and dietary advice is the impact of these interventions on indirect outcomes which may translate to clinical benefit. The outcomes in such trials should be mortality, health-related quality of life, decompensated liver cirrhosis, liver transplantation, and resource use measures including costs of intervention and decreased healthcare use after a minimum follow-up of eight years, to find meaningful differences in the clinically important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The 59 studies included a small number of participants (3631 participants). Study data were sparse. Twenty-eight studies with 1942 participants provided data for analyses. The follow-up of the trial participants ranged from 1 month to 24 months. For trials that reported clinical outcomes, follow-up was 2 months to 24 months. Only two small trials did not raise major concerns for bias (deviation from truth because of the way the trials were conducted), and because of this, there is considerable uncertainty about the findings of this review.The review shows that:- During a follow-up period of 2 to 24 months, clinically important outcomes related to NAFLD such as deaths were rare and none of the participants developed liver-related complications such as liver cirrhosis (scarring of the liver), liver decompensation (complications because of scarring of the liver), liver transplantation, liver cancer, or deaths due to liver disease. This is probably because the trial participants were followed for too short a time.- The evidence indicates considerable uncertainty about the effect of the interventions on any of the clinical outcomes.- Future well-designed randomised clinical trials are needed to find out the best lifestyle modifications for people with NAFLD. Liver-related complications develop over 8 to 28 years. It is therefore unlikely that differences in clinical outcomes will become apparent in trials with less than 5 years to 10 years of follow-up. Sample sizes also need to be much larger."
}
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query-laysum | 4637 | [
{
"role": "user",
"content": "Abstract: Background\nPolicy makers, health staff and communities recognise that health services in lower- and middle-income countries need to improve people's access to HIV treatment and retention to treatment programmes. One strategy is to move antiretroviral delivery from hospitals to more peripheral health facilities or even beyond health facilities. This could increase the number of people with access to care, improve health outcomes, and enhance retention in treatment programmes. On the other hand, providing care at less sophisticated levels in the health service or at community-level may decrease quality of care and result in worse health outcomes. To address these uncertainties, we summarised the research studies examining the risks and benefits of decentralising antiretroviral therapy service delivery.\nObjectives\nTo assess the effects of various models that decentralised HIV treatment and care to more basic levels in the health system for initiating and maintaining antiretroviral therapy.\nSearch methods\nWe conducted a comprehensive search to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress) from 1 January 1996 to 31 March 2013, and contacted relevant organisations and researchers. The search terms included 'decentralisation', 'down referral', 'delivery of health care', and 'health services accessibility'.\nSelection criteria\nOur inclusion criteria were controlled trials (randomised and non-randomised), controlled-before and after studies, and cohorts (prospective and retrospective) in which HIV-infected people were either initiated on antiretroviral therapy or maintained on therapy in a decentralised setting in lower- and middle-income countries. We define decentralisation as providing treatment at a more basic level in the health system to the comparator.\nData collection and analysis\nTwo authors applied the inclusion criteria and extracted data independently. We designed a framework to describe different decentralisation strategies, and then grouped studies against these strategies. Data were pooled using random-effects meta-analysis. Because loss to follow up in HIV programmes is known to include some deaths, we used attrition as our primary outcome, defined as death plus loss to follow-up. We assessed evidence quality with GRADE methodology.\nMain results\nSixteen studies met the inclusion criteria, all but one were from Africa, comprising two cluster randomised trials and 14 cohort studies. Antiretroviral therapy started at a hospital and maintained at a health centre (partial decentralisation) probably reduces attrition (RR 0.46, 95% CI 0.29 to 0.71, 4 studies, 39 090 patients, moderate quality evidence). There may be fewer patients lost to care with this model (RR 0.55, 95% CI 0.45 to 0.69, low quality evidence).\nWe are uncertain whether there is a difference in attrition for antiretroviral therapy started and maintained at a health centre (full decentralisation) compared to a hospital at 12 months (RR 0.70, 95% CI 0.47 to 1.02; four studies, 56 360 patients, very low quality evidence), but there are probably fewer patients lost to care with this model (RR 0.3, 95% CI 0.17 to 0.54, moderate quality evidence).\nWhen antiretroviral maintenance therapy is delivered at home by trained volunteers, there is probably no difference in attrition at 12 months (RR 0.95, 95% CI 0.62 to 1.46, two trials, 1453 patients, moderate quality evidence).\nAuthors' conclusions\nDecentralisation of HIV care aims to improve patient access and retention in care. Most data were from good quality cohort studies but confounding between site of treatment and outcomes cannot be excluded. Nevertheless, this review found that attrition appears to be lower in partial decentralisation models of treatment, where antiretrovirals were started at hospital and continued in the health centre; with antiretroviral drugs started and continued at health centres, no difference in attrition was detected, but there were fewer patients lost to care. For antiretroviral therapy provided at home by trained volunteers, no difference in outcomes were detected when compared to facility-based care.\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 that if antiretroviral therapy was started at a hospital and continued in a health centre (partial decentralisation), there was probably less attrition and fewer patients were lost to care after one year (four studies, 39 090 patients).\nWhere antiretroviral therapy was started and continued at a health centre (full decentralisation), there was probably no difference in the number of deaths and patients lost to follow-up (attrition), but overall, there were probably fewer patients lost to care after one year (four studies, 56 360 patients).\nIf antiretroviral therapy was provided in the community, by trained volunteers, there was probably no difference detected in death or losses to care when compared to care provided at a health centre after one year (two studies, 1 453 patients).\nOverall, none of the models of decentralisation led to worse health outcomes. The research indicates that fewer patients are lost to care when they are continued on antiretroviral therapy at health centres rather than in hospitals. The research also did not detect a difference in the numbers of patients lost to care when they are treated in the community rather than in a health facility."
}
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query-laysum | 4638 | [
{
"role": "user",
"content": "Abstract: Background\nPotential benefits of rapamycin or rapalogs for treating people with tuberous sclerosis complex (TSC) have been shown. Currently everolimus (a rapalog) is only approved for TSC-associated renal angiomyolipoma and subependymal giant cell astrocytoma (SEGA), but not other manifestations of TSC. A systematic review needs to establish evidence for rapamycin or rapalogs for various manifestations in TSC. This is an updated review.\nObjectives\nTo determine the effectiveness of rapamycin or rapalogs in people with TSC for decreasing tumour size and other manifestations and to assess the safety of rapamycin or rapalogs in relation to their adverse effects.\nSearch methods\nWe identified relevant studies from the Cochrane-Central-Register-of-Controlled-Trials (CENTRAL), Ovid MEDLINE and ongoing trials registries with no language restrictions. We searched conference proceedings and abstract books of conferences.\nDate of the last searches: 15 July 2022.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs of rapamycin or rapalogs in people with TSC.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of each study; a third review author verified the extracted data and risk of bias decisions. We assessed the certainty of the evidence using GRADE.\nMain results\nThe current update added seven RCTs, bringing the total number to 10 RCTs (with 1008 participants aged 3 months to 65 years; 484 males). All TSC diagnoses were by consensus criteria as a minimum. In parallel studies, 645 participants received active interventions and 340 placebo. Evidence is low-to-high certainty and study quality is mixed; mostly a low risk of bias across domains, but one study had a high risk of performance bias (lack of blinding) and three studies had a high risk of attrition bias. Manufacturers of the investigational products supported eight studies.\nSystemic administration\nSix studies (703 participants) administered everolimus (rapalog) orally. More participants in the intervention arm reduced renal angiomyolipoma size by 50% (risk ratio (RR) 24.69, 95% confidence interval (CI) 3.51 to 173.41; P = 0.001; 2 studies, 162 participants, high-certainty evidence). In the intervention arm, more participants in the intervention arm reduced SEGA tumour size by 50% (RR 27.85, 95% CI 1.74 to 444.82; P = 0.02; 1 study; 117 participants; moderate-certainty evidence) ,and reported more skin responses (RR 5.78, 95% CI 2.30 to 14.52; P = 0.0002; 2 studies; 224 participants; high-certainty evidence). In one 18-week study (366 participants), the intervention led to 25% fewer seizures (RR 1.63, 95% CI 1.27 to 2.09; P = 0.0001) or 50% fewer seizures (RR 2.28, 95% CI 1.44 to 3.60; P = 0.0004); but there was no difference in numbers being seizure-free (RR 5.30, 95% CI 0.69 to 40.57; P = 0.11) (moderate-certainty evidence). One study (42 participants) showed no difference in neurocognitive, neuropsychiatry, behavioural, sensory and motor development (low-certainty evidence).\nTotal adverse events (AEs) did not differ between groups (RR 1.09, 95% CI 0.97 to 1.22; P = 0.16; 5 studies; 680 participants; high-certainty evidence). However, the intervention group experienced more AEs resulting in withdrawal, interruption of treatment, or reduced dose (RR 2.61, 95% CI 1.58 to 4.33; P = 0.0002; 4 studies; 633 participants; high-certainty evidence and also reported more severe AEs (RR 2.35, 95% CI 0.99 to 5.58; P = 0.05; 2 studies; 413 participants; high-certainty evidence).\nTopical (skin) administration\nFour studies (305 participants) administered rapamycin topically. More participants in the intervention arm showed a response to skin lesions (RR 2.72, 95% CI 1.76 to 4.18; P < 0.00001; 2 studies; 187 participants; high-certainty evidence) and more participants in the placebo arm reported a deterioration of skin lesions (RR 0.27, 95% CI 0.15 to 0.49; 1 study; 164 participants; high-certainty evidence). More participants in the intervention arm responded to facial angiofibroma at one to three months (RR 28.74, 95% CI 1.78 to 463.19; P = 0.02) and three to six months (RR 39.39, 95% CI 2.48 to 626.00; P = 0.009; low-certainty evidence). Similar results were noted for cephalic plaques at one to three months (RR 10.93, 95% CI 0.64 to 186.08; P = 0.10) and three to six months (RR 7.38, 95% CI 1.01 to 53.83; P = 0.05; low-certainty evidence). More participants on placebo showed a deterioration of skin lesions (RR 0.27, 95% CI 0.15 to 0.49; P < 0.0001; 1 study; 164 participants; moderate-certainty evidence). The intervention arm reported a higher general improvement score (MD -1.01, 95% CI -1.68 to -0.34; P < 0.0001), but no difference specifically in the adult subgroup (MD -0.75, 95% CI -1.58 to 0.08; P = 0.08; 1 study; 36 participants; moderate-certainty evidence). Participants in the intervention arm reported higher satisfaction than with placebo (MD -0.92, 95% CI -1.79 to -0.05; P = 0.04; 1 study; 36 participants; low-certainty evidence), although again with no difference among adults (MD -0.25, 95% CI -1.52 to 1.02; P = 0.70; 1 study; 18 participants; low-certainty evidence). Groups did not differ in change in quality of life at six months (MD 0.30, 95% CI -1.01 to 1.61; P = 0.65; 1 study; 62 participants; low-certainty evidence).\nTreatment led to a higher risk of any AE compared to placebo (RR 1.72, 95% CI 1.10, 2.67; P = 0.02; 3 studies; 277 participants; moderate-certainty evidence); but no difference between groups in severe AEs (RR 0.78, 95% CI 0.19 to 3.15; P = 0.73; 1 study; 179 participants; moderate-certainty evidence).\nAuthors' conclusions\nOral everolimus reduces the size of SEGA and renal angiomyolipoma by 50%, reduces seizure frequency by 25% and 50% and implements beneficial effects on skin lesions with no difference in the total number of AEs compared to placebo; however, more participants in the treatment group required a dose reduction, interruption or withdrawal and marginally more experienced serious AEs compared to placebo.\nTopical rapamycin increases the response to skin lesions and facial angiofibroma, an improvement score, satisfaction and the risk of any AE, but not severe adverse events.\nWith caution regarding the risk of severe AEs, this review supports oral everolimus for renal angiomyolipoma, SEGA, seizure, and skin lesions, and topical rapamycin for facial angiofibroma.\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": "The review included 10 studies with 1008 people with tuberous sclerosis complex aged between three months and 65 years of age. However, one study involved five people with sporadic lymphangioleiomyomatosis (without tuberous sclerosis complex) who we could not remove from the analysis. Studies compared rapamycin or rapalogs with placebo (containing no active ingredient) and people were selected for one treatment or the other randomly. The duration of the studies was variable. Two studies were funded by Novartis Pharmaceuticals."
}
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query-laysum | 4639 | [
{
"role": "user",
"content": "Abstract: Background\nLeg ulcers are open skin wounds that occur below the knee but above the foot. The majority of leg ulcers are venous in origin, occurring as a result of venous insufficiency, where the flow of blood through the veins is impaired; they commonly arise due to blood clots and varicose veins. Compression therapy, using bandages or stockings, is the primary treatment for venous leg ulcers. Wound cleansing can be used to remove surface contaminants, bacteria, dead tissue and excess wound fluid from the wound bed and surrounding skin, however, there is uncertainty regarding the effectiveness of cleansing and the best method or solution to use.\nObjectives\nTo assess the effects of wound cleansing, wound cleansing solutions and wound cleansing techniques for treating venous leg ulcers.\nSearch methods\nIn September 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe considered randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or RCTs comparing different wound cleansing solutions, or different wound cleansing techniques.\nData collection and analysis\nWe screened studies for their appropriateness for inclusion, assessed their risk of bias using the Cochrane 'Risk of bias' tool, and used GRADE methodology to determine the certainty of evidence. Two review authors undertook these tasks independently, using predetermined criteria. We contacted study authors for missing data where possible.\nMain results\nWe included four studies with a total of 254 participants. All studies included comparisons between different types of cleansing solutions, and three of these reported our primary outcomes of complete wound healing or change in ulcer size over time, or both. Two studies reported the secondary outcome, pain. One study (27 participants), which compared polyhexamethylene biguanide (PHMB) solution with saline solution for cleansing venous leg ulcers, did not report any of the review's primary or secondary outcomes. We did not identify any studies that compared cleansing with no cleansing, or that explored comparisons between different cleansing techniques.\nOne study (61 participants) compared aqueous oxygen peroxide with sterile water. We are uncertain whether aqueous oxygen peroxide makes any difference to the number of wounds completely healed after 12 months of follow-up (risk ratio (RR) 1.88, 95% confidence interval (CI) 1.10 to 3.20). Similarly, we are uncertain whether aqueous oxygen peroxide makes any difference to change in ulcer size after eight weeks of follow-up (mean difference (MD) -1.38 cm2, 95% CI -4.35 to 1.59 cm2). Finally, we are uncertain whether aqueous oxygen peroxide makes any difference to pain reduction, assessed after eight weeks of follow-up using a 0 to 100 pain rating, (MD 3.80, 95% CI -10.83 to 18.43). The evidence for these outcomes is of very low certainty (we downgraded for study limitations and imprecision; for the pain outcome we also downgraded for indirectness).\nAnother study (40 participants) compared propyl betaine and polihexanide with a saline solution. The authors did not present the raw data in the study report so we were unable to conduct independent statistical analysis of the data. We are uncertain whether propyl betaine and polihexanide make any difference to the number of wounds completely healed, change in ulcer size over time, or wound pain reduction. The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nThe final study (126 participants) compared octenidine dihydrochloride/phenoxyethanol (OHP) with Ringer's solution. We are uncertain whether OHP makes any difference to the number of wounds healed (RR 0.96, 95% CI 0.53 to 1.72) or to the change in ulcer size over time (we were unable to conduct independent statistical analysis of available data). The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nNone of the studies reported patient preference, ease of use of the method of cleansing, cost or health-related quality of life. In one study comparing propyl betaine and polihexanide with saline solution the authors do not report any adverse events occurring. We are uncertain whether OHP makes any difference to the number of adverse events compared with Ringer's solution (RR 0.58, 95% CI 0.29 to 1.14). The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nAuthors' conclusions\nThere is currently a lack of RCT evidence to guide decision making about the effectiveness of wound cleansing compared with no cleansing and the optimal approaches to cleansing of venous leg ulcers. From the four studies identified, there is insufficient evidence to demonstrate whether the use of PHMB solution compared with saline solution; aqueous oxygen peroxide compared with sterile water; propyl betaine and polihexanide compared with a saline solution; or OHP compared with Ringer's solution makes any difference in the treatment of venous leg ulcers. Evidence from three of the studies is of very low certainty, due to study limitations and imprecision. One study did not present data for the primary or secondary outcomes. Further well-designed studies that address important clinical, quality of life and economic outcomes may be important, based on the clinical and patient priority of this uncertainty.\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"
},
{
"role": "assistant",
"content": "The evidence in this Cochrane Review is current to September 2019."
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query-laysum | 4640 | [
{
"role": "user",
"content": "Abstract: Background\nImmunization rates for children and adults are rising, but coverage levels have not reached optimal goals. As a result, vaccine-preventable diseases still occur. In an era of increasing complexity of immunization schedules, rising expectations about the performance of primary care, and large demands on primary care providers, it is important to understand and promote interventions that work in primary care settings to increase immunization coverage. One common theme across immunization programs in many nations involves the challenge of implementing a population-based approach and identifying all eligible recipients, for example the children who should receive the measles vaccine. However, this issue is gradually being addressed through the availability of immunization registries and electronic health records. A second common theme is identifying the best strategies to promote high vaccination rates. Three types of strategies have been studied: (1) patient-oriented interventions, such as patient reminder or recall, (2) provider interventions, and (3) system interventions, such as school laws. One of the most prominent intervention strategies, and perhaps best studied, involves patient reminder or recall systems. This is an update of a previously published review.\nObjectives\nTo evaluate and compare the effectiveness of various types of patient reminder and recall interventions to improve receipt of immunizations.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL to January 2017. We also searched grey literature and trial registers to January 2017.\nSelection criteria\nWe included randomized trials, controlled before and after studies, and interrupted time series evaluating immunization-focused patient reminder or recall interventions in children, adolescents, and adults who receive immunizations in any setting. We included no-intervention control groups, standard practice activities that did not include immunization patient reminder or recall, media-based activities aimed at promoting immunizations, or simple practice-based awareness campaigns. We included receipt of any immunizations as eligible outcome measures, excluding special travel immunizations. We excluded patients who were hospitalized for the duration of the study period.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. We present results for individual studies as relative rates using risk ratios, and risk differences for randomized trials, and as absolute changes in percentage points for controlled before-after studies. We present pooled results for randomized trials using the random-effects model.\nMain results\nThe 75 included studies involved child, adolescent, and adult participants in outpatient, community-based, primary care, and other settings in 10 countries.\nPatient reminder or recall interventions, including telephone and autodialer calls, letters, postcards, text messages, combination of mail or telephone, or a combination of patient reminder or recall with outreach, probably improve the proportion of participants who receive immunization (risk ratio (RR) of 1.28, 95% confidence interval (CI) 1.23 to 1.35; risk difference of 8%) based on moderate certainty evidence from 55 studies with 138,625 participants.\nThree types of single-method reminders improve receipt of immunizations based on high certainty evidence: the use of postcards (RR 1.18, 95% CI 1.08 to 1.30; eight studies; 27,734 participants), text messages (RR 1.29, 95% CI 1.15 to 1.44; six studies; 7772 participants), and autodialer (RR 1.17, 95% CI 1.03 to 1.32; five studies; 11,947 participants). Two types of single-method reminders probably improve receipt of immunizations based on moderate certainty evidence: the use of telephone calls (RR 1.75, 95% CI 1.20 to 2.54; seven studies; 9120 participants) and letters to patients (RR 1.29, 95% CI 1.21 to 1.38; 27 studies; 81,100 participants).\nBased on high certainty evidence, reminders improve receipt of immunizations for childhood (RR 1.22, 95% CI 1.15 to 1.29; risk difference of 8%; 23 studies; 31,099 participants) and adolescent vaccinations (RR 1.29, 95% CI 1.17 to 1.42; risk difference of 7%; 10 studies; 30,868 participants). Reminders probably improve receipt of vaccinations for childhood influenza (RR 1.51, 95% CI 1.14 to 1.99; risk difference of 22%; five studies; 9265 participants) and adult influenza (RR 1.29, 95% CI 1.17 to 1.43; risk difference of 9%; 15 studies; 59,328 participants) based on moderate certainty evidence. They may improve receipt of vaccinations for adult pneumococcus, tetanus, hepatitis B, and other non-influenza vaccinations based on low certainty evidence although the confidence interval includes no effect of these interventions (RR 2.08, 95% CI 0.91 to 4.78; four studies; 8065 participants).\nAuthors' conclusions\nPatient reminder and recall systems, in primary care settings, are likely to be effective at improving the proportion of the target population who receive immunizations.\n\nGiven the provided abstract, please respond to the following query: \"Main results of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our review found that reminding people to have vaccinations likely increases the number of people who receive vaccinations by an average of 8 percentage points, although there was variation in the results of the studies. Reminding people by telephone and autodialer calls, sending a letter or postcard, or sending a text message increased vaccinations. Combinations of reminders were also effective. Reminding people over the telephone was more effective than the other types of reminders. The increases in vaccinations were observed among children, adolescents, and adults."
}
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query-laysum | 4641 | [
{
"role": "user",
"content": "Abstract: Background\nPostpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH.\nObjectives\nTo identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies.\nSelection criteria\nAll randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion.\nData collection and analysis\nTwo review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence.\nMain results\nSeven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion.\nPairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty).\nAccording to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone.\nFor all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear.\nAlthough network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty).\nAuthors' conclusions\nThe available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that oxytocin is probably more effective than misoprostol and is also associated with less side-effects. Giving misoprostol together with oxytocin probably does not improve effectiveness and increases side-effects. The evidence for most available drugs used as first-line treatment of postpartum haemorrhage is limited, with no evidence found for several drugs currently in use."
}
]
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query-laysum | 4642 | [
{
"role": "user",
"content": "Abstract: Background\nPneumonia is the most common hospital-acquired infection affecting patients in the intensive care unit (ICU). However, current national guidelines for the treatment of hospital-acquired pneumonia (HAP) are several years old and the diagnosis of pneumonia in mechanically ventilated patients (VAP) has been subject to considerable recent attention. The optimal duration of antibiotic therapy for HAP in the critically ill is uncertain.\nObjectives\nTo assess the effectiveness of short versus prolonged-course antibiotics for HAP in critically ill adults, including patients with VAP.\nSearch methods\nWe searched CENTRAL (2015, Issue 5), MEDLINE (1946 to June 2015), MEDLINE in-process and other non-indexed citations (5 June 2015), EMBASE (2010 to June 2015), LILACS (1982 to June 2015) and Web of Science (1955 to June 2015).\nSelection criteria\nWe considered all randomised controlled trials (RCTs) comparing a fixed 'short' duration of antibiotic therapy with a 'prolonged' course for HAP (including patients with VAP) in critically ill adults.\nData collection and analysis\nTwo review authors conducted data extraction and assessment of risk of bias. We contacted trial authors for additional information.\nMain results\nWe identified six relevant studies involving 1088 participants. This included two new studies published after the date of our previous review (2011). There was substantial variation in participants, in the diagnostic criteria used to define an episode of pneumonia, in the interventions and in the reported outcomes. We found no evidence relating to patients with a high probability of HAP who were not mechanically ventilated. For patients with VAP, overall a short seven- or eight-day course of antibiotics compared with a prolonged 10- to 15-day course increased 28-day antibiotic-free days (two studies; N = 431; mean difference (MD) 4.02 days; 95% confidence interval (CI) 2.26 to 5.78) and reduced recurrence of VAP due to multi-resistant organisms (one study; N = 110; odds ratio (OR) 0.44; 95% CI 0.21 to 0.95), without adversely affecting mortality and other recurrence outcomes. However, for cases of VAP specifically due to non-fermenting Gram-negative bacilli (NF-GNB), recurrence was greater after short-course therapy (two studies, N = 176; OR 2.18; 95% CI 1.14 to 4.16), though mortality outcomes were not significantly different. One study found that a three-day course of antibiotic therapy for patients with suspected HAP but a low Clinical Pulmonary Infection Score (CPIS) was associated with a significantly lower risk of superinfection or emergence of antimicrobial resistance, compared with standard (prolonged) course therapy.\nAuthors' conclusions\nOn the basis of a small number of studies and appreciating the lack of uniform definition of pneumonia, we conclude that for patients with VAP not due to NF-GNB a short, fixed course (seven or eight days) of antibiotic therapy appears not to increase the risk of adverse clinical outcomes, and may reduce the emergence of resistant organisms, compared with a prolonged course (10 to 15 days). However, for patients with VAP due to NF-GNB, there appears to be a higher risk of recurrence following short-course therapy. These findings do not differ from those of our previous review and are broadly consistent with current guidelines. There are few data from RCTs comparing durations of therapy in non-ventilated patients with HAP, but on the basis of a single study, short-course (three-day) therapy for HAP appears not to be associated with worse clinical outcome, and may reduce the risk of subsequent infection or the emergence of resistant organisms when there is low probability of pneumonia according to the CPIS.\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": "Hospital-acquired pneumonia is the major cause of hospital-acquired infection in the intensive care unit (ICU). There are a number of factors that make the critically ill more likely to develop pneumonia, among which the most important is tracheal intubation performed in conjunction with mechanical ventilation; thus, the majority of ICU patients with HAP have what is termed ventilator-associated pneumonia (VAP).\nThere is concern that an unnecessarily long course of antibiotic therapy may lead to patients acquiring antibiotic-resistant organisms, which may be more difficult to recognise and treat when they cause infection and may increase drug costs. On the other hand, too short a course risks the treatment failing."
}
]
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query-laysum | 4643 | [
{
"role": "user",
"content": "Abstract: Background\nIn many countries emergency departments (EDs) are facing an increase in demand for services, long waits, and severe crowding. One response to mitigate overcrowding has been to provide primary care services alongside or within hospital EDs for patients with non-urgent problems. However, it is unknown how this impacts the quality of patient care and the utilisation of hospital resources, or if it is cost-effective. This is the first update of the original Cochrane Review published in 2012.\nObjectives\nTo assess the effects of locating primary care professionals in hospital EDs to provide care for patients with non-urgent health problems, compared with care provided by regularly scheduled emergency physicians (EPs).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (the Cochrane Library; 2017, Issue 4), MEDLINE, Embase, CINAHL, PsycINFO, and King's Fund, from inception until 10 May 2017. We searched ClinicalTrials.gov and the WHO ICTRP for registered clinical trials, and screened reference lists of included papers and relevant systematic reviews.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies, and interrupted time series studies that evaluated the effectiveness of introducing primary care professionals to hospital EDs attending to patients with non-urgent conditions, as compared to the care provided by regularly scheduled EPs.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe identified four trials (one randomised trial and three non-randomised trials), one of which is newly identified in this update, involving a total of 11,463 patients, 16 general practitioners (GPs), 9 emergency nurse practitioners (NPs), and 69 EPs. These studies evaluated the effects of introducing GPs or emergency NPs to provide care to patients with non-urgent problems in the ED, as compared to EPs for outcomes such as resource use. The studies were conducted in Ireland, the UK, and Australia, and had an overall high or unclear risk of bias. The outcomes investigated were similar across studies, and there was considerable variation in the triage system used, the level of expertise and experience of the medical practitioners, and type of hospital (urban teaching, suburban community hospital). Main sources of funding were national or regional health authorities and a medical research funding body.\nThere was high heterogeneity across studies, which precluded pooling data. It is uncertain whether the intervention reduces time from arrival to clinical assessment and treatment or total length of ED stay (1 study; 260 participants), admissions to hospital, diagnostic tests, treatments given, or consultations or referrals to hospital-based specialist (3 studies; 11,203 participants), as well as costs (2 studies; 9325 participants), as we assessed the evidence as being of very low-certainty for all outcomes.\nNo data were reported on adverse events (such as ED returns and mortality).\nAuthors' conclusions\nWe assessed the evidence from the four included studies as of very low-certainty overall, as the results are inconsistent and safety has not been examined. The evidence is insufficient to draw conclusions for practice or policy regarding the effectiveness and safety of care provided to non-urgent patients by GPs and NPs versus EPs in the ED to mitigate problems of overcrowding, wait times, and patient flow.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In many countries, EDs are under a lot of pressure due to high patient attendance, resulting in long waits. One way of solving this problem may be to place primary care professionals in EDs to provide care for patients who do not have problems assessed as urgent at arrival. It has been suggested that this would make emergency physicians more available to provide care to more serious cases, thus decreasing resource use and costs."
}
]
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query-laysum | 4644 | [
{
"role": "user",
"content": "Abstract: Background\nMotion sickness is a syndrome that occurs as a result of passive body movement in response to actual motion, or the illusion of motion when exposed to virtual and moving visual environments. The most common symptoms are nausea and vomiting. Antihistamines have been used in the management of motion sickness for decades, however studies have shown conflicting results regarding their efficacy.\nObjectives\nTo assess the effectiveness of antihistamines in the prevention and treatment of motion sickness in adults and children.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 December 2021.\nSelection criteria\nRandomised controlled trials (RCTs) in susceptible adults and children in whom motion sickness was induced under natural conditions such as air, sea and land transportation. We also included studies in which motion sickness was induced under experimental conditions (analysed separately). Antihistamines were included regardless of class, route or dosage and compared to no treatment, placebo or any other pharmacological or non-pharmacological interventions.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1) the proportion of susceptible participants who did not experience any motion sickness symptoms; 2) the proportion of susceptible participants who experienced a reduction or resolution of existing symptoms. Secondary outcomes were 1) physiological measures (heart rate, core temperature and gastric tachyarrhythmia (electrogastrography)) and 2) adverse effects (sedation, impaired cognition, blurred vision). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included nine RCTs (658 participants). Studies were conducted across seven countries, with an overall age range of 16 to 55 years. Motion sickness was induced naturally in six studies and experimentally in four studies (rotating chair). All the naturally induced studies only evaluated first-generation antihistamines (cinnarizine and dimenhydrinate). Risk of bias across the studies varied, with mostly low risk for random sequence generation and allocation concealment, and mostly high risk for selective reporting. Only the experimentally induced studies measured physiological parameters and only the naturally induced studies evaluated adverse effects. There were no studies that clearly assessed the paediatric population.\nAntihistamines versus placebo or no treatment\nAntihistamines are probably more effective than placebo at preventing motion sickness symptoms under natural conditions (symptoms prevented: 25% placebo; 40% antihistamines) (risk ratio (RR) 1.81, 95% confidence interval (CI) 1.23 to 2.66; 3 studies; 240 participants) (moderate-certainty). The evidence is very uncertain about the effect of antihistamines on preventing motion sickness under experimental conditions (standardised mean difference (SMD) 0.32, 95% CI -0.18 to 0.83; 2 studies; 62 participants) (very low-certainty). No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia under experimental conditions (mean difference (MD) -2.2, 95% CI -11.71 to 7.31; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. When compared to placebo, antihistamines may be more likely to cause sedation (sedation: 44% placebo; 66% antihistamines) (RR 1.51, 95% CI 1.12 to 2.02; 2 studies; 190 participants) (low-certainty); they may result in little or no difference in blurred vision (blurred vision: 12.5% placebo; 14% antihistamines) (RR 1.14, 95% CI 0.53 to 2.48; 2 studies; 190 participants) (low-certainty); and they may result in little or no difference in terms of impaired cognition (impaired cognition: 33% placebo; 29% antihistamines) (RR 0.89, 95% CI 0.58 to 1.38; 2 studies; 190 participants) (low-certainty).\nAntihistamines versus scopolamine\nThe evidence is very uncertain about the effect of antihistamines on preventing motion sickness under natural conditions when compared to scopolamine (symptoms prevented: 81% scopolamine; 71% antihistamines) (RR 0.89, 95% CI 0.68 to 1.16; 2 studies; 71 participants) (very low-certainty). No studies were performed under experimental conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nThe evidence is very uncertain about the effect of antihistamines on heart rate under natural conditions (narrative report, 1 study; 20 participants; \"No difference in pulse frequency\"; very low-certainty). No studies reported results for any other physiological measures. When compared to scopolamine, the evidence is very uncertain about the effect of antihistamines on sedation (sedation: 21% scopolamine; 30% antihistamines) (RR 0.82, 95% CI 0.07 to 9.25; 2 studies; 90 participants) (very low-certainty) and on blurred vision (narrative report: not a significant difference; 1 study; 51 participants; very low-certainty). No studies evaluated impaired cognition.\nAntihistamines versus antiemetics\nAntihistamines may result in little or no difference in the prevention of motion sickness under experimental conditions (MD -0.20, 95% CI -10.91 to 10.51; 1 study; 42 participants) (low-certainty). The evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect. No studies assessed the effects of antihistamines versus antiemetics under natural conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. No studies evaluated sedation, impaired cognition or blurred vision.\nOne study reported physiological data for this outcome, evaluating gastric tachyarrhythmia specifically. Antihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants; low-certainty evidence). This evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect.\nAntihistamines versus acupuncture\nThe evidence is very uncertain about the effects of antihistamines on the prevention of motion sickness under experimental conditions when compared to acupuncture (RR 1.32, 95% CI 1.12 to 1.57; 1 study; 100 participants) (very low-certainty). This study did not assess the prevention of motion sickness under natural conditions, nor the resolution of existing motion sickness symptoms. There was no study performed under natural conditions.\nPhysiological measures and adverse effects were not reported.\nAuthors' conclusions\nThere is probably a reduction in the risk of developing motion sickness symptoms under naturally occurring conditions of motion when using first-generation antihistamines, in motion sickness-susceptible adults, compared to placebo. Antihistamines may be more likely to cause sedation when compared to placebo. No studies evaluated the treatment of existing motion sickness, and there are few data on the effect of antihistamines in children. The evidence for all other outcomes and comparisons (versus scopolamine, antiemetics and acupuncture) was of low or very low certainty and we are therefore uncertain about these effects of antihistamines.\n\nGiven the provided abstract, please respond to the following query: \"Antihistamines versus placebo\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results show that antihistamines are probably more effective than placebo at preventing motion sickness symptoms under natural conditions.\nThere is uncertainty about whether or not antihistamines are effective at preventing motion sickness, or if they have an effect on gastric tachyarrhythmia (the way the inside of your stomach moves), under experimental conditions (in a laboratory setting) when compared to placebo.\nAntihistamines may be more likely to cause sedation (drowsiness) when compared to placebo. There is uncertainty about whether antihistamines cause blurred vision (not being able to see clearly) or impaired cognition (not being able to think clearly) when compared to placebo."
}
]
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query-laysum | 4646 | [
{
"role": "user",
"content": "Abstract: Background\nMycoplasma pneumoniae (M. pneumoniae) is widely recognised as an important cause of community-acquired lower respiratory tract infection (LRTI) in children. Pulmonary manifestations are typically tracheobronchitis or pneumonia but M. pneumoniae is also implicated in wheezing episodes in both asthmatic and non-asthmatic individuals. Although antibiotics are used to treat LRTIs, a review of several major textbooks offers conflicting advice for using antibiotics in the management of M. pneumoniae LRTI in children.\nObjectives\nTo determine whether antibiotics are effective in the treatment of childhood LRTI secondary to M. pneumoniae infections acquired in the community.\nSearch methods\nWe searched CENTRAL (2014, Issue 3), MEDLINE (1966 to July week 4, 2014), EMBASE (1980 to July, 2014), and both WHO ICTRP and ClinicalTrials.gov (13 August 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing antibiotics commonly used for treating M. pneumoniae (i.e. macrolide, tetracycline or quinolone classes) versus placebo, or antibiotics from any other class in the treatment of children under 18 years of age with community-acquired LRTI secondary to M. pneumoniae.\nData collection and analysis\nThe review authors independently selected trials for inclusion and assessed methodological quality. We extracted and analysed relevant data separately and resolved disagreements by consensus.\nMain results\nA total of 1912 children were enrolled from seven studies. Data interpretation was limited by the inability to extract data that referred to children with M. pneumoniae. In most studies, clinical response did not differ between children randomised to a macrolide antibiotic and children randomised to a non-macrolide antibiotic. In one controlled study (of children with recurrent respiratory infections, whose acute LRTI was associated with Mycoplasma, Chlamydia or both, by polymerase chain reaction and/or paired sera) 100% of children treated with azithromycin had clinical resolution of their illness compared to 77% not treated with azithromycin at one month.\nAuthors' conclusions\nThere is insufficient evidence to draw any specific conclusions about the efficacy of antibiotics for this condition in children (although one trial suggests macrolides may be efficacious in some children with LRTI secondary to Mycoplasma). The use of antibiotics has to be balanced with possible adverse events. There is still a need for high quality, double-blinded RCTs to assess the efficacy and safety of antibiotics for LRTI secondary to M. pneumoniae in children.\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 sought to answer the question of whether antibiotics are effective in the treatment of LRTIs caused by the bacteriaMycoplasma pneumoniae(M. pneumoniae) in children."
}
]
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