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query-laysum | 4950 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovary syndrome (PCOS) is a common endocrine condition, affecting approximately one in 10 women. PCOS is defined by two of three features: oligo- or anovulation, clinical or biochemical hyperandrogenism or both, or polycystic ovaries.\nWomen with PCOS can have a wide range of health problems, including infrequent and irregular periods, unwanted hair growth and acne, and subnormal fertility. Long-term health concerns include an increased risk of heart disease, diabetes and the development of precancerous disease of the womb.\nObjectives\nTo assess the effectiveness and harms of ovarian surgery as a treatment for symptomatic relief of hirsutism, acne and menstrual irregularity in PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group specialized register, CENTRAL, MEDLINE, Embase and PsycINFO (from inception to 17 October 2016). We handsearched citation lists, registers of ongoing trials and conference proceedings.\nSelection criteria\nWe included randomized controlled trials (RCTs) of women undergoing ovarian drilling in comparison to no treatment, medical treatment, or other forms of surgical treatment for the symptoms of PCOS.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary outcome measures were improvement in menstrual regularity and androgenic symptoms of PCOS (hirsutism, acne); the secondary outcome measures included harms, change of body mass index (BMI), waist circumference, androgen levels, metabolic measures and quality of life. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe included 22 RCTs (2278 women analyzed) of participants with PCOS and symptoms of acne, hirsutism or irregular menstrual cycles, all of which included laparoscopic ovarian drilling (LOD) as an intervention.\nTwo studies reported their funding source (Farquhar 2002 - supported in part by the Auckland Medical Research Foundation; Sarouri 2015 - the authors thank the Vice Chancellor for Research of Guilan University of Medical Sciences for funding this project).\nThe quality of the evidence ranged from very low to moderate quality. The main limitations were imprecision associated with the low number of studies, inconsistency and risk of bias associated with the inability to blind participants. There were too few studies to assess risk of publication bias.\nMenstrual Regularity\nTwo studies compared LOD versus metformin (n=226) but no conclusions could be drawn with regard to menstrual regularity, as their findings were inconsistent and they were unsuitable for pooling. There appeared to be little or no difference in the rate of women reporting improvement in menstrual regularity when LOD was compared with medical treatment including metformin + clomiphene (OR 1.02, 95% CI 0.64 to 1.64, 2 studies, 332 women, I2 = 13%, low-quality evidence), letrozole (OR 1.08, 95% CI 0.64 to 1.84, 1 study, 260 women, low-quality evidence), or metformin + letrozole (OR 0.95, 95% CI 0.49 to 1.81, 1 study, 146 women, low-quality evidence). However, one study reported that LOD was superior to gonadotrophin (OR 19.2, 95% CI 3.17 to 116.45, 1 study, 35 women, very low-quality evidence).\nThere appeared to be little or no difference in the rate of women reporting improvement in menstrual regularity when bilateral unipolar LOD was compared to unilateral LOD (OR 1.51, 95% CI 0.62 to 3.71, 2 studies, 104 women, I2 = 0%, moderate-quality evidence), transvaginal ultrasound-guided LOD (OR 1.23, 95% CI 0.64 to 2.37, 1 study, 147 women, low-quality evidence), LOD using adjusted thermal dose in accordance with the ovarian volume (OR 0.42, 95% CI 0.16 to 1.14, 1 study, 115 women, low-quality evidence) or bipolar LOD (OR 1.00, 95% CI 0.05 to 18.57, 1 study, 18 women, low-quality evidence).\nFour to five punctures per ovary may improve the rate of women reporting menstrual regularity compared with two or fewer (OR 16.04, 95% CI 4.19 to 61.34, 2 studies, 73 women, I2 = 0%, low-quality evidence).\nAndrogenic Symptoms\nThere was probably little or no difference in improvement in androgenic symptoms when LOD was compared to metformin (OR 1.00, 95% CI 0.42 to 2.37, 1 study, 126 women, moderate-quality evidence) or gonadotrophins; acne (OR 3.20, 95% CI 0.33 to 30.94, 1 study, 25 women, low-quality evidence), hirsutism (OR 2.31, 95% CI 0.22 to 23.89, 1 study, 25 women, low-quality evidence).\nThere appeared to be little or no difference in improvement of androgenic symptoms when LOD was compared to transvaginal ultrasound-guided LOD, with respect to hirsutism (OR 1.09, 95% CI 0.30 to 3.91, 1 study, 39 women, low-quality evidence) or acne (OR 0.84, 95% CI 0.20 to 3.50, 1 study, 31 women, low-quality evidence).\nHarms\nLOD was associated with fewer gastrointestinal side effects than metformin plus clomiphene (OR 0.05, 95% CI 0.01 to 0.36, 2 studies, 332 women, I2 = 0%, moderate-quality evidence). One study suggested little or no difference in rates of ovarian hyperstimulation syndrome between LOD and gonadotrophins (OR 0.08, 95% CI 0.00 to 1.61, 1 study, 33 women, low-quality evidence).\nThere were fewer adhesions with transvaginal hydrolaparoscopy compared to LOD (OR 0.10, 95% CI 0.05 to 0.18, 1 study, 246 women, moderate-quality evidence). There appeared to be little or no difference in adhesions when variable energy LOD was compared with standard LOD (OR 0.96, 95% CI 0.32 to 2.88, 1 study, 64 women, low-quality evidence). Another study (44 women) reported that none of the women who returned for surgery following either traditional or unilateral LOD were found to have adhesions.\nAuthors' conclusions\nThere was no clear evidence that LOD improves menstrual regularity or the androgenic symptoms of PCOS, compared to most of the medical treatments used in the included studies. LOD was associated with fewer gastrointestinal side effects compared to metformin and clomiphene.\nThere was also no clear evidence of different effectiveness between types of LOD, except that LOD with four to five punctures per ovary may be more effective than two or fewer punctures. There was little evidence comparing LOD with different types of surgery, although one study concluded that transvaginal hydrolaparoscopy had a lower risk of adhesions than LOD.\nThere was evidence from one small study of benefit from LOD compared to gonadotrophins for menstrual regulation. However, gonadotrophins are seldom used for this indication.\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 October 2016."
}
]
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query-laysum | 4951 | [
{
"role": "user",
"content": "Abstract: Background\nInadvertent perioperative hypothermia (a drop in core temperature to below 36°C) occurs because normal temperature regulation is disrupted during surgery, mainly because of the effects of anaesthetic drugs and exposure of the skin for prolonged periods. Many different ways of maintaining body temperature have been proposed, one of which involves administration of intravenous nutrients during the perioperative period that may reduce heat loss by increasing metabolism, thereby increasing heat production.\nObjectives\nTo assess the effectiveness of preoperative or intraoperative intravenous nutrients in preventing perioperative hypothermia and its complications during surgery in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; November 2015) in the Cochrane Library; MEDLINE, Ovid SP (1956 to November 2015); Embase, Ovid SP (1982 to November 2015); the Institute for Scientific Information (ISI) Web of Science (1950 to November 2015); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCO host; 1980 to November 2015), as well as the reference lists of identified articles. We also searched the Current Controlled Trials website and ClincalTrials.gov.\nSelection criteria\nRandomized controlled trials (RCTs) of intravenous nutrients compared with control or other interventions given to maintain normothermia in adults undergoing surgery.\nData collection and analysis\nTwo review authors extracted data and assessed risk of bias for each included trial, and a third review author checked details if necessary. We contacted some study authors to request additional information.\nMain results\nWe included 14 trials (n = 565), 13 (n = 525) of which compared intravenous administration of amino acids to a control (usually saline solution or Ringer's lactate). The remaining trial (n = 40) compared intravenous administration of fructose versus a control. We noted much variation in these trials, which used different types of surgery, variable durations of surgery, and different types of participants. Most trials were at high or unclear risk of bias owing to inappropriate or unclear randomization methods, and to unclear participant and assessor blinding. This may have influenced results, but it is unclear how results might have been influenced.\nNo trials reported any of our prespecified primary outcomes, which were risk of hypothermia and major cardiovascular events. Therefore, we decided to analyse data related to core body temperature instead as a primary outcome. It was not possible to conduct meta-analysis of data related to amino acid infusion for the 60-minute and 120-minute time points, as we observed significant statistical heterogeneity in the results. Some trials showed that higher temperatures were associated with amino acids, but not all trials reported statistically significant results, and some trials reported the opposite result, where the amino acid group had a lower core temperature than the control group. It was possible to conduct meta-analysis for six studies (n = 249) that provided data relating to the end of surgery. Amino acids led to a statistically significant increase in core temperature in comparison to those receiving control (MD = 0.46°C 95% CI 0.33 to 0.59; I2 0.0%; random-effects; moderate quality evidence).\nThree trials (n = 155) reported shivering as an outcome. Meta-analysis did not show a clear effect, and so it is uncertain whether amino acids reduce the risk of shivering (RR 0.36, 95% CI 0.13 to 1.00; I2 = 93%; random-effects model; very low-quality evidence).\nAuthors' conclusions\nIntravenous amino acids may keep participants up to a half-degree C warmer than the control. This difference was statistically significant at the end of surgery, but not at other time points. However, the clinical importance of this finding remains unclear. It is also unclear whether amino acids have any effect on the risk of shivering and if intravenous nutrients confer any other benefits or harms, as high-quality data about these outcomes are lacking.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out about the effects that intravenous nutrients (amino acids or sugars given into the bloodstream through a tube or a catheter in a vein) have on adults having surgery. Giving intravenous nutrients increases a person's metabolism, and this may increase the body heat produced. We wanted to know if giving intravenous nutrients during a surgical procedure could keep people warm, and if intravenous nutrients can keep them from having problems caused by being cold."
}
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query-laysum | 4952 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review published in 2015.\nEpilepsy is a chronic neurological disorder, characterised by recurring, unprovoked seizures. Vagus nerve stimulation (VNS) is a neuromodulatory treatment that is used as an adjunctive therapy for treating people with drug-resistant epilepsy. VNS consists of chronic, intermittent electrical stimulation of the vagus nerve, delivered by a programmable pulse generator.\nObjectives\nTo evaluate the efficacy and tolerability of VNS when used as add-on treatment for people with drug-resistant focal epilepsy.\nSearch methods\nFor this update, we searched the Cochrane Register of Studies (CRS), and MEDLINE Ovid on 3 March 2022. We imposed no language restrictions. CRS Web includes randomised or quasi-randomised controlled trials from the Specialised Registers of Cochrane Review Groups, including Epilepsy, CENTRAL, PubMed, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform.\nSelection criteria\nWe considered parallel or cross-over, randomised, double-blind, controlled trials of VNS as add-on treatment, which compared high- and low-level stimulation (including three different stimulation paradigms: rapid, mild, and slow duty-cycle), and VNS stimulation versus no stimulation, or a different intervention. We considered adults or children with drug-resistant focal seizures who were either not eligible for surgery, or who had failed surgery.\nData collection and analysis\nWe followed standard Cochrane methods, assessing the following outcomes:\n1. 50% or greater reduction in seizure frequency\n2. Treatment withdrawal (any reason)\n3. Adverse effects\n4. Quality of life (QoL)\n5. Cognition\n6. Mood\nMain results\nWe did not identify any new studies for this update, therefore, the conclusions are unchanged.\nWe included the five randomised controlled trials (RCT) from the last update, with a total of 439 participants. The baseline phase ranged from 4 to 12 weeks, and double-blind treatment phases from 12 to 20 weeks. We rated two studies at an overall low risk of bias, and three at an overall unclear risk of bias, due to lack of reported information about study design. Effective blinding of studies of VNS is difficult, due to the frequency of stimulation-related side effects, such as voice alteration.\nThe risk ratio (RR) for 50% or greater reduction in seizure frequency was 1.73 (95% confidence interval (CI) 1.13 to 2.64; 4 RCTs, 373 participants; moderate-certainty evidence), showing that high frequency VNS was over one and a half times more effective than low frequency VNS.\nThe RR for treatment withdrawal was 2.56 (95% CI 0.51 to 12.71; 4 RCTs, 375 participants; low-certainty evidence). Results for the top five reported adverse events were: hoarseness RR 2.17 (99% CI 1.49 to 3.17; 3 RCTs, 330 participants; moderate-certainty evidence); cough RR 1.09 (99% CI 0.74 to 1.62; 3 RCTs, 334 participants; moderate-certainty evidence); dyspnoea RR 2.45 (99% CI 1.07 to 5.60; 3 RCTs, 312 participants; low-certainty evidence); pain RR 1.01 (99% CI 0.60 to 1.68; 2 RCTs; 312 participants; moderate-certainty evidence); paraesthesia 0.78 (99% CI 0.39 to 1.53; 2 RCTs, 312 participants; moderate-certainty evidence).\nResults from two studies (312 participants) showed that a small number of favourable QOL effects were associated with VNS stimulation, but results were inconclusive between high- and low-level stimulation groups. One study (198 participants) found inconclusive results between high- and low-level stimulation for cognition on all measures used. One study (114 participants) found the majority of participants showed an improvement in mood on the Montgomery–Åsberg Depression Rating Scale compared to baseline, but results between high- and low-level stimulation were inconclusive.\nWe found no important heterogeneity between studies for any of the outcomes.\nAuthors' conclusions\nVNS for focal seizures appears to be an effective and well-tolerated treatment. Results of the overall efficacy analysis show that high-level stimulation reduced the frequency of seizures better than low-level stimulation. There were very few withdrawals, which suggests that VNS is well tolerated.\nAdverse effects associated with implantation and stimulation were primarily hoarseness, cough, dyspnoea, pain, paraesthesia, nausea, and headache, with hoarseness and dyspnoea more likely to occur with high-level stimulation than low-level stimulation.\nHowever, the evidence for these outcomes is limited, and of moderate to low certainty.\nFurther high-quality research is needed to fully evaluate the efficacy and tolerability of VNS for drug-resistant focal seizures.\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": "The evidence for the effectiveness and side effects of VNS therapy was limited and imprecise. There were a small number of studies and participants included in the review, and details about the design and conduct of the trials was sometimes lacking. We rated the evidence as moderate or low certainty. This means that further research is likely, or very likely, to have an important impact on our confidence in the estimate of the effect, and may change the estimate."
}
]
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query-laysum | 4953 | [
{
"role": "user",
"content": "Abstract: Background\nMotor control exercise (MCE) is used by healthcare professionals worldwide as a common treatment for low back pain (LBP). However, the effectiveness of this intervention for acute LBP remains unclear.\nObjectives\nTo evaluate the effectiveness of MCE for patients with acute non-specific LBP.\nSearch methods\nWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), four other databases and two trial registers from their inception to April 2015, tracked citations and searched reference lists. We placed no limitations on language nor on publication status.\nSelection criteria\nWe included only randomised controlled trials (RCTs) examining the effectiveness of MCE for patients with acute non-specific LBP. We considered trials comparing MCE versus no treatment, versus another type of treatment or added as a supplement to other interventions. Primary outcomes were pain intensity and disability. Secondary outcomes were function, quality of life and recurrence.\nData collection and analysis\nTwo review authors screened for potentially eligible studies, assessed risk of bias and extracted data. A third independent review author resolved disagreements. We examined MCE in the following comparisons: (1) MCE versus spinal manipulative therapy; (2) MCE versus other exercises; and (3) MCE as a supplement to medical management. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the quality of evidence. For missing or unclear information, we contacted study authors. We considered the following follow-up intervals: short term (less than three months after randomisation); intermediate term (at least three months but within 12 months after randomisation); and long term (12 months or longer after randomisation).\nMain results\nWe included three trials in this review (n = 197 participants). Study sample sizes ranged from 33 to 123 participants. Low-quality evidence indicates no clinically important differences between MCE and spinal manipulative therapy for pain at short term and for disability at short term and long term. Low-quality evidence also suggests no clinically important differences between MCE and other forms of exercise for pain at short or intermediate term and for disability at intermediate term or long term follow-up. Moderate-quality evidence shows no clinically important differences between MCE and other forms of exercise for disability at short term follow-up. Finally, very low-quality evidence indicates that addition of MCE to medical management does not provide clinically important improvement for pain or disability at short term follow-up. For recurrence at one year, very low-quality evidence suggests that MCE and medical management decrease the risk of recurrence by 64% compared with medical management alone.\nAuthors' conclusions\nWe identified only three small trials that also evaluated different comparisons; therefore, no firm conclusions can be drawn on the effectiveness of MCE for acute LBP. Evidence of very low to moderate quality indicates that MCE showed no benefit over spinal manipulative therapy, other forms of exercise or medical treatment in decreasing pain and disability among patients with acute and subacute low back pain. Whether MCE can prevent recurrences of LBP remains uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To evaluate the effectiveness of motor control exercise (MCE) for patients with acute non-specific low back pain (LBP)."
}
]
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query-laysum | 4954 | [
{
"role": "user",
"content": "Abstract: Background\nExperiencing anxiety and depression is very common in people living with dementia and mild cognitive impairment (MCI). There is uncertainty about the best treatment approach. Drug treatments may be ineffective and associated with adverse effects. Guidelines recommend psychological treatments. In this updated systematic review, we investigated the effectiveness of different psychological treatment approaches.\nObjectives\nPrimary objective\nTo assess the clinical effectiveness of psychological interventions in reducing depression and anxiety in people with dementia or MCI.\nSecondary objectives\nTo determine whether psychological interventions improve individuals' quality of life, cognition, activities of daily living (ADL), and reduce behavioural and psychological symptoms of dementia, and whether they improve caregiver quality of life or reduce caregiver burden.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, four other databases, and three trials registers on 18 February 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared a psychological intervention for depression or anxiety with treatment as usual (TAU) or another control intervention in people with dementia or MCI.\nData collection and analysis\nA minimum of two authors worked independently to select trials, extract data, and assess studies for risk of bias. We classified the included psychological interventions as cognitive behavioural therapies (cognitive behavioural therapy (CBT), behavioural activation (BA), problem-solving therapy (PST)); 'third-wave' therapies (such as mindfulness-based cognitive therapy (MBCT)); supportive and counselling therapies; and interpersonal therapies. We compared each class of intervention with control. We expressed treatment effects as standardised mean differences or risk ratios. Where possible, we pooled data using a fixed-effects model. We used GRADE methods to assess the certainty of the evidence behind each result.\nMain results\nWe included 29 studies with 2599 participants. They were all published between 1997 and 2020. There were 15 trials of cognitive behavioural therapies (4 CBT, 8 BA, 3 PST), 11 trials of supportive and counselling therapies, three trials of MBCT, and one of interpersonal therapy. The comparison groups received either usual care, attention-control education, or enhanced usual care incorporating an active control condition that was not a specific psychological treatment. There were 24 trials of people with a diagnosis of dementia, and five trials of people with MCI. Most studies were conducted in community settings. We considered none of the studies to be at low risk of bias in all domains.\nCognitive behavioural therapies (CBT, BA, PST)\nCognitive behavioural therapies are probably slightly better than treatment as usual or active control conditions for reducing depressive symptoms (standardised mean difference (SMD) -0.23, 95% CI -0.37 to -0.10; 13 trials, 893 participants; moderate-certainty evidence). They may also increase rates of depression remission at the end of treatment (risk ratio (RR) 1.84, 95% CI 1.18 to 2.88; 2 studies, with one study contributing 2 independent comparisons, 146 participants; low-certainty evidence). We were very uncertain about the effect of cognitive behavioural therapies on anxiety at the end of treatment (SMD -0.03, 95% CI -0.36 to 0.30; 3 trials, 143 participants; very low-certainty evidence). Cognitive behavioural therapies probably improve patient quality of life (SMD 0.31, 95% CI 0.13 to 0.50; 7 trials, 459 participants; moderate-certainty evidence) and activities of daily living at end of treatment compared to treatment as usual or active control (SMD -0.25, 95% CI -0.40 to -0.09; 7 trials, 680 participants; moderate-certainty evidence).\nSupportive and counselling interventions\nMeta-analysis showed that supportive and counselling interventions may have little or no effect on depressive symptoms in people with dementia compared to usual care at end of treatment (SMD -0.05, 95% CI -0.18 to 0.07; 9 trials, 994 participants; low-certainty evidence). We were very uncertain about the effects of these treatments on anxiety, which was assessed only in one small pilot study.\nOther interventions\nThere were very few data and very low-certainty evidence on MBCT and interpersonal therapy, so we were unable to draw any conclusions about the effectiveness of these interventions.\nAuthors' conclusions\nCBT-based treatments added to usual care probably slightly reduce symptoms of depression for people with dementia and MCI and may increase rates of remission of depression. There may be important effect modifiers (degree of baseline depression, cognitive diagnosis, or content of the intervention). CBT-based treatments probably also have a small positive effect on quality of life and activities of daily living. Supportive and counselling interventions may not improve symptoms of depression in people with dementia. Effects of both types of treatment on anxiety symptoms are very uncertain. We are also uncertain about the effects of other types of psychological treatments, and about persistence of effects over time. To inform clinical guidelines, future studies should assess detailed components of these interventions and their implementation in different patient populations and in different settings.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up to date to February 2021."
}
]
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query-laysum | 4955 | [
{
"role": "user",
"content": "Abstract: Background\nOral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. It was previously found that 5-ASA drugs in doses of at least 2 g/day were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis (UC). This review is an update of a previously published Cochrane Review.\nObjectives\nTo assess the efficacy, dose-responsiveness and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators (i.e. other formulations of 5-ASA) for induction of remission in active UC. A secondary objective was to compare the efficacy and safety of once-daily dosing of oral 5-ASA versus conventional dosing regimens (two or three times daily).\nSearch methods\nWe searched MEDLINE, Embase and the Cochrane Library on 11 June 2019. We also searched references, conference proceedings and study registers to identify additional studies.\nSelection criteria\nWe considered randomized controlled trials (RCTs) including adults (aged 18 years or more) with active UC for inclusion. We included studies that compared oral 5-ASA therapy with placebo, SASP, or other 5-ASA formulations. We also included studies that compared once-daily to conventional dosing as well as dose-ranging studies.\nData collection and analysis\nOutcomes include failure to induce global/clinical remission, global/clinical improvement, endoscopic remission, endoscopic improvement, adherence, adverse events (AEs), serious adverse events (SAEs), withdrawals due to AEs, and withdrawals or exclusions after entry. We analyzed five comparisons: 5-ASA versus placebo, 5-ASA versus sulfasalazine, once-daily dosing versus conventional dosing, 5-ASA (e.g. MMX mesalamine, Ipocol, Balsalazide, Pentasa, Olsalazine and 5-ASA micropellets) versus comparator 5-ASA (e.g. Asacol, Claversal, Salofalk), and 5-ASA dose-ranging. We calculated the risk ratio (RR) and 95% confidence interval (95% CI) for each outcome. We analyzed data on an intention-to-treat basis, and used GRADE to assess the overall certainty of the evidence.\nMain results\nWe include 54 studies (9612 participants). We rated most studies at low risk of bias.\nSeventy-one per cent (1107/1550) of 5-ASA participants failed to enter clinical remission compared to 83% (695/837) of placebo participants (RR 0.86, 95% CI 0.82 to 0.89; 2387 participants, 11 studies; high-certainty evidence). We also observed a dose-response trend for 5-ASA. There was no difference in clinical remission rates between 5-ASA and SASP. Fifty-four per cent (150/279) of 5-ASA participants failed to enter remission compared to 58% (144/247) of SASP participants (RR 0.90, 95% CI 0.77 to 1.04; 526 participants, 8 studies; moderate-certainty evidence).\nThere was no difference in remission rates between once-daily dosing and conventional dosing. Sixty per cent (533/881) of once-daily participants failed to enter clinical remission compared to 61% (538/880) of conventionally-dosed participants (RR 0.99, 95% CI 0.93 to 1.06; 1761 participants, 5 studies; high-certainty evidence). Eight per cent (15/179) of participants dosed once daily failed to adhere to their medication regimen compared to 6% (11/179) of conventionally-dosed participants (RR 1.36, 95% CI 0.64 to 2.86; 358 participants, 2 studies; low-certainty evidence).\nThere does not appear to be any difference in efficacy among the various 5-ASA formulations. Fifty per cent (507/1022) of participants in the 5-ASA group failed to enter remission compared to 52% (491/946) of participants in the 5-ASA comparator group (RR 0.94, 95% CI 0.86 to 1.02; 1968 participants, 11 studies; moderate-certainty evidence).\nThere was no evidence of a difference in the incidence of adverse events and serious adverse events between 5-ASA and placebo, once-daily and conventionally-dosed 5-ASA, and 5-ASA and comparator 5-ASA formulation studies. Common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache and worsening UC. SASP was not as well tolerated as 5-ASA. Twenty-nine per cent (118/411) of SASP participants experienced an AE compared to 15% (72/498) of 5-ASA participants (RR 0.48, 95% CI 0.36 to 0.63; 909 participants, 12 studies; moderate-certainty evidence).\nAuthors' conclusions\nThere is high-certainty evidence that 5-ASA is superior to placebo, and moderate-certainty evidence that 5-ASA is not more effective than SASP. Considering relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. High-certainty evidence suggests 5-ASA dosed once daily appears to be as efficacious as conventionally-dosed 5-ASA. There may be little or no difference in efficacy or safety among the various 5-ASA formulations.\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": "This review includes 54 randomized trials with a total of 9612 people taking part. The review includes studies published up to June 2019. Oral 5-ASA was found to be more effective than placebo (fake drug). Although oral 5-ASA drugs are effective for treating active UC, they are no more effective than SASP therapy. People taking 5-ASA are less likely to experience side effects than those taking SASP. Side effects associated with 5-ASA are generally mild in nature, and common side effects include digestive tract symptoms (e.g. flatulence, abdominal pain, nausea, and diarrhea), headache and worsening UC. 5-ASA compounds are more expensive than SASP, so SASP may be the preferred option where cost is an important factor. 5-ASA given once daily appears to be as effective as 5-ASA given in the usual way (two or three times daily). There do not appear to be any differences in effectiveness or safety among the various 5-ASA formulations."
}
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query-laysum | 4956 | [
{
"role": "user",
"content": "Abstract: Background\nMaintenance of remission is a major issue in inflammatory bowel disease. In ulcerative colitis, the evidence for the effectiveness of azathioprine and 6-mercaptopurine for the maintenance of remission is still controversial.\nObjectives\nTo assess the effectiveness and safety of azathioprine and 6-mercaptopurine for maintaining remission of ulcerative colitis.\nSearch methods\nThe MEDLINE, EMBASE and Cochrane Library databases were searched from inception to 30 July 2015. Both full randomized controlled trials and associated abstracts were included.\nSelection criteria\nRandomized controlled trials of at least 12 months duration that compared azathioprine or 6-mercaptopurine with placebo or standard maintenance therapy (e.g. mesalazine) were included.\nData collection and analysis\nTwo authors independently extracted data using standard forms. Disagreements were solved by consensus including a third author. Study quality was assessed using the Cochrane risk of bias tool. The primary outcome was failure to maintain clinical or endoscopic remission. Secondary outcomes included adverse events and withdrawal due to adverse events. Analyses were performed separately by type of control (placebo, or active comparator). Pooled risk ratios were calculated based on the fixed-effect model unless heterogeneity was shown. The GRADE approach was used to assess the overall quality of evidence for pooled outcomes.\nMain results\nSeven studies including 302 patients with ulcerative colitis were included in the review. The risk of bias was high in three of the studies due to lack of blinding. Azathioprine was shown to be significantly superior to placebo for maintenance of remission. Fourty-four per cent (51/115) of azathioprine patients failed to maintain remission compared to 65% (76/117) of placebo patients (4 studies, 232 patients; RR 0.68, 95% CI 0.54 to 0.86). A GRADE analysis rated the overall quality of the evidence for this outcome as low due to risk of bias and imprecision (sparse data). Two trials that compared 6-mercaptopurine to mesalazine, or azathioprine to sulfasalazine showed significant heterogeneity and thus were not pooled. Fifty per cent (7/14) of 6-mercaptopurine patients failed to maintain remission compared to 100% (8/8) of mesalazine patients (1 study, 22 patients; RR 0.53, 95% CI 0.31 to 0.90). Fifty-eight per cent (7/12) of azathioprine patients failed to maintain remission compared to 38% (5/13) of sulfasalazine patients (1 study, 25 patients; RR 1.52, 95% CI 0.66 to 3.50). One small study found that 6-mercaptopurine was superior to methotrexate for maintenance of remission. In the study, 50% (7/14) of 6-mercaptopurine patients and 92% (11/12) of methotrexate patients failed to maintain remission (1 study, 26 patients; RR 0.55, 95% CI 0.31 to 0.95). One very small study compared azathioprine with cyclosporin and found that there was no significant difference between patients failing remission on azathioprine (50%, 4/8) or cyclosporin (62.5%, 5/8) (1 study, 16 patients, RR 0.80 95% CI 0.33 to 1.92). When placebo-controlled studies were pooled with aminosalicylate-comparator studies to assess adverse events, there was no statistically significant difference between azathioprine and control in the incidence of adverse events. Nine per cent (11/127) of azathioprine patients experienced at least one adverse event compared to 2% (3/130) of placebo patients (5 studies, 257 patients; RR 2.82, 95% CI 0.99 to 8.01). Patients receiving azathioprine were at significantly increased risk of withdrawing due to adverse events. Eight per cent (8/101) of azathioprine patients withdrew due to adverse events compared to 0% (0/98) of control patients (5 studies, 199 patients; RR 5.43, 95% CI 1.02 to 28.75). Adverse events related to study medication included acute pancreatitis (3 cases, plus 1 case on cyclosporin) and significant bone marrow suppression (5 cases). Deaths, opportunistic infection or neoplasia were not reported.\nAuthors' conclusions\nAzathioprine therapy appears to be more effective than placebo for maintenance of remission in ulcerative colitis. Azathioprine or 6-mercaptopurine may be effective as maintenance therapy for patients who have failed or cannot tolerate mesalazine or sulfasalazine and for patients who require repeated courses of steroids. More research is needed to evaluate superiority over standard maintenance therapy, especially in the light of a potential for adverse events from azathioprine. This review updates the existing review of azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis which was published in the Cochrane Library (September 2012).\n\nGiven the provided abstract, please respond to the following query: \"What is the bottom line?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Azathioprine may be an effective maintenance treatment for patients who have failed or cannot tolerate mesalazine or sulfasalazine and for patients who require repeated courses of steroids."
}
]
|
query-laysum | 4957 | [
{
"role": "user",
"content": "Abstract: Background\nUrinary tract infection (UTI) is a common bacterial infection that can lead to significant morbidity including stricture, abscess formation, fistula, bacteraemia, sepsis, pyelonephritis and kidney dysfunction. Mortality rates are reported to be as high as 1% in men and 3% in women due to development of pyelonephritis. Because probiotic therapy is readily available without a prescription, a review of their efficacy in the prevention of UTI may aid consumers in making informed decisions about potential prophylactic therapy. Institutions and caregivers also need evidence-based synopses of current evidence to make informed patient care decisions.\nObjectives\nCompared to placebo or no therapy, did probiotics (any formulation) provide a therapeutic advantage in terms of morbidity and mortality, when used to prevent UTI in susceptible patient populations?\nCompared to other prophylactic interventions, including drug and non-drug measures (e.g. continuous antibiotic prophylaxis, topical oestrogen, cranberry juice), did probiotics (any formulation) provide a therapeutic advantage in terms of morbidity and mortality when used to prevent UTIs in susceptible patient populations?\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 21 September 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review.\nSelection criteria\nRandomised controlled trials (RCTs) of susceptible patients (e.g. past history of UTI) or healthy people in which any strain, formulation, dose or frequency of probiotic was compared to placebo or active comparators were included.\nData collection and analysis\nAll RCTs and quasi-RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods) looking at comparing probiotics to no therapy, placebo, or other prophylactic interventions were included. 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.\nMain results\nWe included nine studies that involved 735 people in this review. Four studies compared probiotic with placebo, two compared probiotic with no treatment, two compared probiotics with antibiotics in patients with UTI, and one study compared probiotic with placebo in healthy women. All studies aimed to measure differences in rates of recurrent UTI.\nOur risk of bias assessment found that most studies had small sample sizes and reported insufficient methodological detail to enable robust assessment. Overall, there was a high risk of bias in the included studies which lead to inability to draw firm conclusions and suggesting that any reported treatment effects may be misleading or represent overestimates.\nWe found no significant reduction in the risk of recurrent symptomatic bacterial UTI between patients treated with probiotics and placebo (6 studies, 352 participants: RR 0.82, 95% CI 0.60 to 1.12; I2 = 23%) with wide confidence intervals, and statistical heterogeneity was low. No significant reduction in the risk of recurrent symptomatic bacterial UTI was found between probiotic and antibiotic treated patients (1 study, 223 participants: RR 1.12, 95% CI 0.95 to 1.33).\nThe most commonly reported adverse effects were diarrhoea, nausea, vomiting, constipation and vaginal symptoms. None of the included studies reported numbers of participants with at least one asymptomatic bacterial UTI, all-cause mortality or those with at least one confirmed case of bacteraemia or fungaemia. Two studies reported study withdrawal due to adverse events and the number of participants who experienced at least one adverse event. One study reported withdrawal occurred in six probiotic participants (5.2%), 15 antibiotic participants (12.2%), while the second study noted one placebo group participant discontinued treatment due to an adverse event.\nAuthors' conclusions\nNo significant benefit was demonstrated for probiotics compared with placebo or no treatment, but a benefit cannot be ruled out as the data were few, and derived from small studies with poor methodological reporting.\nThere was limited information on harm and mortality with probiotics and no evidence on the impact of probiotics on serious adverse events. Current evidence cannot rule out a reduction or increase in recurrent UTI in women with recurrent UTI who use prophylactic probiotics. There was insufficient evidence from one RCT to comment on the effect of probiotics versus antibiotics.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We conducted a literature search up to September 2015 and nine studies were eligible for inclusion according to our selection criteria. The nine studies reported data on 735 participants and investigated probiotics for preventing UTI: seven studies involved women or girls with recurrent UTIs, one looked at children with abnormal urinary tracts, and one investigated UTI in healthy women."
}
]
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query-laysum | 4958 | [
{
"role": "user",
"content": "Abstract: Background\nMechanical ventilation is a potentially painful and discomforting intervention that is widely used in neonatal intensive care. Newborn infants demonstrate increased sensitivity to pain, which may affect clinical and neurodevelopmental outcomes. The use of drugs that reduce pain might be important in improving survival and neurodevelopmental outcomes.\nObjectives\nTo determine the benefits and harms of opioid analgesics for neonates (term or preterm) receiving mechanical ventilation compared to placebo or no drug, other opioids, or other analgesics or sedatives.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 9), in the Cochrane Library; MEDLINE via PubMed (1966 to 29 September 2020); Embase (1980 to 29 September 2020); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 29 September 2020). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing opioids to placebo or no drug, to other opioids, or to other analgesics or sedatives in newborn infants on mechanical ventilation. We excluded cross-over trials. We included term (≥ 37 weeks' gestational age) and preterm (< 37 weeks' gestational age) newborn infants on mechanical ventilation. We included any duration of drug treatment and any dosage given continuously or as bolus; we excluded studies that gave opioids to ventilated infants for procedures.\nData collection and analysis\nFor each of the included trials, we independently extracted data (e.g. number of participants, birth weight, gestational age, types of opioids) using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included 23 studies (enrolling 2023 infants) published between 1992 and 2019. Fifteen studies (1632 infants) compared the use of morphine or fentanyl versus placebo or no intervention. Four studies included both term and preterm infants, and one study only term infants; all other studies included only preterm infants, with five studies including only very preterm infants. We are uncertain whether opioids have an effect on the Premature Infant Pain Profile (PIPP) Scale in the first 12 hours after infusion (MD -5.74, 95% confidence interval (CI) -6.88 to -4.59; 50 participants, 2 studies) and between 12 and 48 hours after infusion (MD -0.98, 95% CI -1.35 to -0.61; 963 participants, 3 studies) because of limitations in study design, high heterogeneity (inconsistency), and imprecision of estimates (very low-certainty evidence - GRADE). The use of morphine or fentanyl probably has little or no effect in reducing duration of mechanical ventilation (MD 0.23 days, 95% CI -0.38 to 0.83; 1259 participants, 7 studies; moderate-certainty evidence because of unclear risk of bias in most studies) and neonatal mortality (RR 1.12, 95% CI 0.80 to 1.55; 1189 participants, 5 studies; moderate-certainty evidence because of imprecision of estimates). We are uncertain whether opioids have an effect on neurodevelopmental outcomes at 18 to 24 months (RR 2.00, 95% CI 0.39 to 10.29; 78 participants, 1 study; very low-certainty evidence because of serious imprecision of the estimates and indirectness). Limited data were available for the other comparisons (i.e. two studies (54 infants) on morphine versus midazolam, three (222 infants) on morphine versus fentanyl, and one each on morphine versus diamorphine (88 infants), morphine versus remifentanil (20 infants), fentanyl versus sufentanil (20 infants), and fentanyl versus remifentanil (24 infants)). For these comparisons, no meta-analysis was conducted because outcomes were reported by one study.\nAuthors' conclusions\nWe are uncertain whether opioids have an effect on pain and neurodevelopmental outcomes at 18 to 24 months; the use of morphine or fentanyl probably has little or no effect in reducing the duration of mechanical ventilation and neonatal mortality. Data on the other comparisons planned in this review (opioids versus analgesics; opioids versus other opioids) are extremely limited and do not allow any conclusions. In the absence of firm evidence to support a routine policy, opioids should be used selectively - based on clinical judgement and evaluation of pain indicators - although pain measurement in newborns has limitations.\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": "We searched for studies that had been published up to 29 September 2020."
}
]
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query-laysum | 4959 | [
{
"role": "user",
"content": "Abstract: Background\nIn 2011 the World Health Organization (WHO) recommended parenteral artesunate in preference to quinine as first-line treatment for people with severe malaria. Prior to this recommendation many countries, particularly in Africa, had begun to use artemether, an alternative artemisinin derivative. This Cochrane Review evaluates intramuscular artemether compared with both quinine and artesunate.\nObjectives\nTo assess the efficacy and safety of intramuscular artemether versus any other parenteral medication in the treatment of severe malaria in adults and children.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, and LILACS, ISI Web of Science, conference proceedings, and reference lists of articles. We also searched the WHO International Clinical Trial Registry Platform, ClinicalTrials.gov, and the metaRegister of Controlled Trials (mRCT) for ongoing trials up to 7 September 2018. We checked the reference lists of all studies identified by the search. We examined references listed in review articles and previously compiled bibliographies to look for eligible studies.\nSelection criteria\nRandomized controlled trials (RCTs) comparing intramuscular artemether with intravenous/intramuscular quinine or artesunate for treating severe malaria.\nData collection and analysis\nThe primary outcome was all-cause death. Two review authors independently screened each article by title and abstract, and examined potentially relevant studies for inclusion using an eligibility form. Two review authors independently extracted data and assessed risk of bias of included studies. We summarized dichotomous outcomes using risk ratios (RRs) and continuous outcomes using mean differences (MDs), and have presented both measures with 95% confidence intervals (CIs). Where appropriate, we combined data in meta-analyses and used the GRADE approach to summarize the certainty of the evidence.\nMain results\nWe included 19 RCTs, enrolling 2874 adults and children with severe malaria, carried out in Africa (12 trials) and in Asia (7 trials).\nArtemether versus quinine\nFor children, there is probably little or no difference in the risk of death between intramuscular artemether and quinine (RR 0.97, 95% CI 0.77 to 1.21; 13 trials, 1659 participants, moderate-certainty evidence). Coma resolution time may be about five hours shorter with artemether (MD −5.45, 95% CI −7.90 to −3.00; six trials, 358 participants, low-certainty evidence). Artemether may make little difference to neurological sequelae (RR 0.84, 95% CI 0.66 to 1.07; seven trials, 968 participants, low-certainty evidence). Compared to quinine, artemether probably shortens the parasite clearance time by about nine hours (MD −9.03, 95% CI −11.43 to −6.63; seven trials, 420 participants, moderate-certainty evidence), and may shorten the fever clearance time by about three hours (MD −3.73, 95% CI −6.55 to −0.92; eight trials, 457 participants, low-certainty evidence).\nFor adults, treatment with intramuscular artemether probably results in fewer deaths than treatment with quinine (RR 0.59, 95% CI 0.42 to 0.83; four trials, 716 participants, moderate-certainty evidence).\nArtemether versus artesunate\nArtemether and artesunate have not been directly compared in randomized trials in children.\nFor adults, mortality is probably higher with intramuscular artemether (RR 1.80, 95% CI 1.09 to 2.97; two trials, 494 participants, moderate-certainty evidence).\nAuthors' conclusions\nArtemether appears to be more effective than quinine in children and adults. Artemether compared to artesunate has not been extensively studied, but in adults it appears inferior. These findings are consistent with the WHO recommendations that artesunate is the drug of choice, but artemether is acceptable when artesunate is not available.\n\nGiven the provided abstract, please respond to the following query: \"Artemether versus quinine\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For children, intramuscular artemether is probably as good as quinine at preventing deaths from severe malaria (moderate-certainty evidence). Artemether may shorten time to coma resolution by about five hours (low-certainty evidence), and may reduce the number of children with signs of brain damage at the time of hospital discharge (low-certainty evidence).\nIn older children (> 15 years) and adults, treatment with artemether probably results in fewer deaths than quinine (moderate-certainty evidence)."
}
]
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query-laysum | 4960 | [
{
"role": "user",
"content": "Abstract: Background\nUreteroscopy combined with laser stone fragmentation and basketing is a common approach for managing renal and ureteral stones. This procedure is associated with some degree of ureteral trauma. Ureteral trauma may lead to swelling, ureteral obstruction, and flank pain and may require subsequent interventions such as hospital admission or secondary ureteral stent placement. To prevent such issues, urologists often place temporary ureteral stents prophylactically, but the value of doing so remains unclear.\nObjectives\nTo assess the effects of postoperative ureteral stent placement after uncomplicated ureteroscopy.\nSearch methods\nWe performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings, up to 01 February 2019. We applied no restrictions on publication language or status.\nSelection criteria\nWe included trials in which researchers randomised participants undergoing uncomplicated ureteroscopy to placement of a ureteral stent versus no ureteral stent.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.\nMain results\nPrimary outcomes\nStenting may slightly reduce the number of unplanned return visits (16 trials with 1970 participants; very low CoE), but we are very uncertain of this finding.\nPain on the day of surgery as measured on a visual analogue scale (scale 0 to 10; higher values reflect more pain) is probably similar (mean difference (MD) 0.32 higher, 95% confidence interval (CI) 0.13 lower to 0.78 higher; 4 trials with 346 participants; moderate CoE). Pain on postoperative days 1 to 3 may show little to no difference (standardised mean difference (SMD) 0.25 higher, 95% CI 0.32 lower to 0.82 higher; 8 trials with 683 participants; low CoE). On postoperative days 4 to 30, stented participants may experience more pain (8 trials with 903 participants; very low CoE), but we are very uncertain of this finding.\nStenting may result in little to no difference in the need for secondary interventions (risk ratio (RR) 1.15, 95% CI 0.39 to 3.33; 10 studies with 1435 participants; low CoE); this corresponds to three more interventions per 1000 participants (95% CI 13 fewer to 48 more).\nSecondary outcomes\nStenting may reduce the need for narcotics (7 trials with 830 participants; very low CoE), but we are very uncertain of this finding.\nRates of urinary tract infection (UTI) up to 90 days are probably not substantially different (RR 0.94, 95% CI 0.59 to 1.51; 10 trials with 1207 participants; moderate CoE); this corresponds to three fewer infections per 1000 participants (95% CI 23 fewer to 29 more).\nUreteral stricture rates up to 90 days may be slightly reduced (14 trials with 1625 participants; very low CoE), but we are very uncertain of this finding.\nRates of hospital admission may be slightly reduced (RR 0.70, 95% CI 0.32 to 1.55; 13 studies with 1647 participants; low CoE). This corresponds to 15 fewer admissions per 1000 participants (95% CI 33 fewer to 27 more).\nAuthors' conclusions\nFindings of this review illustrate the trade-offs of risks and benefits faced by urologists and their patients when it comes to decision-making about stent placement after uncomplicated ureteroscopy for stone disease. We noted that both desirable and undesirable effects were small in absolute terms, with findings based mostly on low and very low CoE. The main issues reducing our confidence in research findings were study limitations (mostly risk of performance and detection bias) and imprecision. We were unable to conduct any of the preplanned subgroup analyses, in particular those based on stone size, stone location, and use of ureteral dilation, which may be important effect modifiers. Given the importance of this question, higher-quality and sufficiently large trials are needed to better inform decision-making.\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": "For patients with stones in the kidney or in the tube draining urine from the kidney to the bladder that have been removed from the inside by a ureteroscope (a very thin scope), how does placing a stent (a small plastic tube in the ureter) compare to not using a stent?"
}
]
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query-laysum | 4961 | [
{
"role": "user",
"content": "Abstract: Background\nThe most frequent indications for tooth extractions, generally performed by general dental practitioners, are dental caries and periodontal infections. Systemic antibiotics may be prescribed to patients undergoing extractions to prevent complications due to infection. This is an update of a review first published in 2012.\nObjectives\nTo determine the effect of systemic antibiotic prophylaxis on the prevention of infectious complications following tooth extractions.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health Trials Register (to 16 April 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 3), MEDLINE Ovid (1946 to 16 April 2020), Embase Ovid (1980 to 16 April 2020), and LILACS (1982 to 16 April 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, double-blind, placebo-controlled trials of systemic antibiotic prophylaxis in patients undergoing tooth extraction(s) for any indication.\nData collection and analysis\nAt least two review authors independently performed data extraction and 'Risk of bias' assessment for the included studies. We contacted trial authors for further details where these were unclear. For dichotomous outcomes, we calculated risk ratios (RR) and 95% confidence intervals (CI) using random-effects models. For continuous outcomes, we used mean differences (MD) with 95% CI using random-effects models. We examined potential sources of heterogeneity. We assessed the certainty of the body of evidence for key outcomes as high, moderate, low, or very low, using the GRADE approach.\nMain results\nWe included 23 trials that randomised approximately 3206 participants (2583 analysed) to prophylactic antibiotics or placebo. Although general dentists perform dental extractions because of severe dental caries or periodontal infection, only one of the trials evaluated the role of antibiotic prophylaxis in groups of patients affected by those clinical conditions.\nWe assessed 16 trials as being at high risk of bias, three at low risk, and four as unclear.\nCompared to placebo, antibiotics may reduce the risk of postsurgical infectious complications in patients undergoing third molar extractions by approximately 66% (RR 0.34, 95% CI 0.19 to 0.64; 1728 participants; 12 studies; low-certainty evidence), which means that 19 people (95% CI 15 to 34) need to be treated with antibiotics to prevent one infection following extraction of impacted wisdom teeth. Antibiotics may also reduce the risk of dry socket by 34% (RR 0.66, 95% CI 0.45 to 0.97; 1882 participants; 13 studies; low-certainty evidence), which means that 46 people (95% CI 29 to 62) need to take antibiotics to prevent one case of dry socket following extraction of impacted wisdom teeth.\nThe evidence for our other outcomes is uncertain: pain, whether measured dichotomously as presence or absence (RR 0.59, 95% CI 0.31 to 1.12; 675 participants; 3 studies) or continuously using a visual analogue scale (0-to-10-centimetre scale, where 0 is no pain) (MD −0.26, 95% CI −0.59 to 0.07; 422 participants; 4 studies); fever (RR 0.66, 95% CI 0.24 to 1.79; 475 participants; 4 studies); and adverse effects, which were mild and transient (RR 1.46, 95% CI 0.81 to 2.64; 1277 participants; 8 studies) (very low-certainty evidence).\nWe found no clear evidence that the timing of antibiotic administration (preoperative, postoperative, or both) was important.\nThe included studies enrolled a subset of patients undergoing dental extractions, that is healthy people who had surgical extraction of third molars. Consequently, the results of this review may not be generalisable to all people undergoing tooth extractions.\nAuthors' conclusions\nThe vast majority (21 out of 23) of the trials included in this review included only healthy patients undergoing extraction of impacted third molars, often performed by oral surgeons. None of the studies evaluated tooth extraction in immunocompromised patients. We found low-certainty evidence that prophylactic antibiotics may reduce the risk of infection and dry socket following third molar extraction when compared to placebo, and very low-certainty evidence of no increase in the risk of adverse effects. On average, treating 19 healthy patients with prophylactic antibiotics may stop one person from getting an infection. It is unclear whether the evidence in this review is generalisable to patients with concomitant illnesses or patients at a higher risk of infection. Due to the increasing prevalence of bacteria that are resistant to antibiotic treatment, clinicians should evaluate if and when to prescribe prophylactic antibiotic therapy before a dental extraction for each patient on the basis of the patient's clinical conditions (healthy or affected by systemic pathology) and level of risk from infective complications. Immunocompromised patients, in particular, need an individualised approach in consultation with their treating medical specialist.\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": "This is an updated review. The evidence is current to April 2020."
}
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query-laysum | 4962 | [
{
"role": "user",
"content": "Abstract: Background\nNocturia is the bothersome symptom of awakening one or more times per night to void. Desmopressin is a commonly used medication for treating nocturia.\nObjectives\nTo assess the effects of desmopressin as compared to other interventions in the treatment of nocturia in men.\nSearch methods\nWe performed a comprehensive search of the medical literature with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017.\nSelection criteria\nWe included randomised or quasi-randomised trials. Inclusion criteria were men with nocturia defined as one or more voids per night. We excluded trials of children or adults with primary or secondary enuresis or underlying distinct disorders.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We compared desmopressin with placebo, behavioural modification, alpha-blockers, in combination with alpha-blockers against alpha-blockers alone, and in combination with alpha-blocker against alpha-blocker plus anticholinergic. Our outcomes were mean number of voids, quality of life, adverse events, and sleep disturbance.\nMain results\nWe included 14 studies with 2966 randomised men across five comparisons. The studies recruited from urology outpatients clinics and defined nocturia as two or more voids per night. The average age of study participants ranged between 57 and 74 years.\nDesmopressin versus placebo: based on short-term follow-up (up to three months), desmopressin may result in a small, possibly unimportant effect on the number of nocturnal voids (mean difference (MD) -0.61, 95% confidence interval (CI) -0.96 to -0.27; low-quality evidence). We are uncertain about the effect of desmopressin on major adverse events at short-term follow-up (risk ratio (RR) 0.97, 95% CI 0.10 to 9.03; very low-quality evidence). For intermediate-term follow-up (three to 12 months), desmopressin may reduce the number of nocturnal voids in an appreciable number of men (MD -0.85, 95% CI -1.17 to -0.53; low-quality evidence). There was one major adverse event in the desmopressin group at intermediate-term follow-up in one trial of 115 men (RR 3.05, 95% CI 0.13 to 73.39 for both outcomes; low-quality evidence). We found no evidence on quality of life. Subgroup analyses suggest a larger effect on nocturnal voiding with oral, higher-dose formulations of desmopressin and in men with documented nocturnal polyuria.\nDesmopressin versus behaviour modification: there were no data regarding the effect on the number of nocturnal voids, quality of life, or major adverse events.\nDesmopressin versus alpha-blocker: based on short-term follow-up in one small trial, desmopressin likely has a similar effect on the number of nocturnal voids (MD 0.30, 95% CI -0.20 to 0.80; moderate-quality evidence) and quality of life measured on the International Prostate Symptom Score (IPSS) scale (MD 0.00, 95% CI -0.35 to 0.35; moderate-quality evidence). There were no major adverse events in either group.\nDesmopressin plus alpha-blocker versus alpha-blocker alone: based on short-term follow-up, combination therapy likely results in a small, unimportant effect on the number of nocturnal voids (MD -0.47, 95% CI -0.73 to -0.21; moderate-quality evidence) and quality of life (MD -0.29, 95% CI -0.51 to -0.07; moderate-quality evidence). The risk of major adverse events may be similar (0.5% versus 0.3%; RR 0.30, 95% CI 0.01 to 7.32; low-quality evidence).\nDesmopressin plus alpha-blocker versus alpha-blocker plus an anticholinergic: based on short-term follow-up, combination therapy likely results in little or no difference in the number of nocturnal voids (MD -0.43, 95% CI -0.97 to 0.11; moderate-quality evidence). We found no evidence on quality of life or sleep duration. There were no major adverse events in either study group.\nAuthors' conclusions\nDesmopressin may reduce the number of nocturnal voids by a small amount compared to placebo in intermediate-term (three to 12 months) follow-up without increasing major adverse events. We found insufficient evidence to determine the effects of desmopressin when compared with behaviour modification. The effect on the number of nocturnal voids in the short term is likely to be similar to that of alpha-blockers, with very infrequent major adverse events. There appears to be little added benefit in the combined use of desmopressin with an alpha-blocker. The findings of this review were limited by short-term follow-up, study limitations, and imprecision.\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 is up-to-date to 1 August 2017. We identified 14 clinical trials including 2966 men. We compared desmopressin alone or in combination with other medicines used for urinary problems (such as alpha-blockers or anticholinergics) against placebo (pretend treatment), behaviour changes, or medicines used for urinary problems alone or in combination. Most of the included studies enrolled only older men."
}
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query-laysum | 4963 | [
{
"role": "user",
"content": "Abstract: Background\nTonic-clonic convulsions and convulsive status epilepticus (currently defined as a tonic-clonic convulsion lasting at least 30 minutes) are medical emergencies and require urgent and appropriate anticonvulsant treatment. International consensus is that an anticonvulsant drug should be administered for any tonic-clonic convulsion that has been continuing for at least five minutes. Benzodiazepines (diazepam, lorazepam, midazolam) are traditionally regarded as first-line drugs and phenobarbital, phenytoin and paraldehyde as second-line drugs. This is an update of a Cochrane Review first published in 2002 and updated in 2008.\nObjectives\nTo evaluate the effectiveness and safety of anticonvulsant drugs used to treat any acute tonic-clonic convulsion of any duration, including established convulsive (tonic-clonic) status epilepticus in children who present to a hospital or emergency medical department.\nSearch methods\nFor the latest update we searched the Cochrane Epilepsy Group's Specialised Register (23 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 23 May 2017), MEDLINE (Ovid, 1946 to 23 May 2017), ClinicalTrials.gov (23 May 2017), and the WHO International Clinical Trials Registry Platform (ICTRP, 23 May 2017).\nSelection criteria\nRandomised and quasi-randomised trials comparing any anticonvulsant drugs used for the treatment of an acute tonic-clonic convulsion including convulsive status epilepticus in children.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and extracted data. We contacted study authors for additional information.\nMain results\nThe review includes 18 randomised trials involving 2199 participants, and a range of drug treatment options, doses and routes of administration (rectal, buccal, nasal, intramuscular and intravenous). The studies vary by design, setting and population, both in terms of their ages and also in their clinical situation. We have made many comparisons of drugs and of routes of administration of drugs in this review; our key findings are as follows:\n(1) This review provides only low- to very low-quality evidence comparing buccal midazolam with rectal diazepam for the treatment of acute tonic-clonic convulsions (risk ratio (RR) for seizure cessation 1.25, 95% confidence interval (CI) 1.13 to 1.38; 4 trials; 690 children). However, there is uncertainty about the effect and therefore insufficient evidence to support its use. There were no included studies which compare intranasal and buccal midazolam.\n(2) Buccal and intranasal anticonvulsants were shown to lead to similar rates of seizure cessation as intravenous anticonvulsants, e.g. intranasal lorazepam appears to be as effective as intravenous lorazepam (RR 0.96, 95% CI 0.82 to 1.13; 1 trial; 141 children; high-quality evidence) and intranasal midazolam was equivalent to intravenous diazepam (RR 0.98, 95% CI 0.91 to 1.06; 2 trials; 122 children; moderate-quality evidence).\n(3) Intramuscular midazolam also showed a similar rate of seizure cessation to intravenous diazepam (RR 0.97, 95% CI 0.87 to 1.09; 2 trials; 105 children; low-quality evidence).\n(4) For intravenous routes of administration, lorazepam appears to be as effective as diazepam in stopping acute tonic clonic convulsions: RR 1.04, 95% CI 0.94 to 1.16; 3 trials; 414 children; low-quality evidence. Furthermore, we found no statistically significant or clinically important differences between intravenous midazolam and diazepam (RR for seizure cessation 1.08, 95% CI 0.97 to 1.21; 1 trial; 80 children; moderate-quality evidence) or intravenous midazolam and lorazepam (RR for seizure cessation 0.98, 95% CI 0.91 to 1.04; 1 trial; 80 children; moderate-quality evidence). In general, intravenously-administered anticonvulsants led to more rapid seizure cessation but this was usually compromised by the time taken to establish intravenous access.\n\n(5) There is limited evidence from a single trial to suggest that intranasal lorazepam may be more effective than intramuscular paraldehyde in stopping acute tonic-clonic convulsions (RR 1.22, 95% CI 0.99 to 1.52; 160 children; moderate-quality evidence).\n(6) Adverse side effects were observed and reported very infrequently in the included studies. Respiratory depression was the most common and most clinically relevant side effect and, where reported, the frequency of this adverse event was observed in 0% to up to 18% of children. None of the studies individually demonstrated any difference in the rates of respiratory depression between the different anticonvulsants or their different routes of administration; but when pooled, three studies (439 children) provided moderate-quality evidence that lorazepam was significantly associated with fewer occurrences of respiratory depression than diazepam (RR 0.72, 95% CI 0.55 to 0.93).\nMuch of the evidence provided in this review is of mostly moderate to high quality. However, the quality of the evidence provided for some important outcomes is low to very low, particularly for comparisons of non-intravenous routes of drug administration. Low- to very low-quality evidence was provided where limited data and imprecise results were available for analysis, methodological inadequacies were present in some studies which may have introduced bias into the results, study settings were not applicable to wider clinical practice, and where inconsistency was present in some pooled analyses.\nAuthors' conclusions\nWe have not identified any new high-quality evidence on the efficacy or safety of an anticonvulsant in stopping an acute tonic-clonic convulsion that would inform clinical practice. There appears to be a very low risk of adverse events, specifically respiratory depression. Intravenous lorazepam and diazepam appear to be associated with similar rates of seizure cessation and respiratory depression. Although intravenous lorazepam and intravenous diazepam lead to more rapid seizure cessation, the time taken to obtain intravenous access may undermine this effect. In the absence of intravenous access, buccal midazolam or rectal diazepam are therefore acceptable first-line anticonvulsants for the treatment of an acute tonic-clonic convulsion that has lasted at least five minutes. There is no evidence provided by this review to support the use of intranasal midazolam or lorazepam as alternatives to buccal midazolam or rectal diazepam.\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": "Many of the trials used different drugs, different dosages and different routes of administration. This has to be taken into account when looking at the overall conclusion of this review. Most of the trials took place in large children’s hospitals or in large children’s departments in a general hospital. This means that the results found in this review are probably relevant for similar clinical situations throughout the world.\nThe quality of the evidence provided in this review ranged from very low to high. The quality of the evidence provided for some outcomes is low to very low, due to imprecise results where limited information was available for analysis. There were also variability and problems within the designs of some studies, which may have influenced the findings. The quality of evidence was lower in some study settings which were specific to the country in which they were conducted, so the results may not reflect clinical practice worldwide.\nThe evidence is current to May 2017."
}
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query-laysum | 4964 | [
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia is a clinically defined chronic condition of unknown etiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. People with fibromyalgia often report high disability levels and poor quality of life. Drug therapy, for example, with serotonin and noradrenaline reuptake inhibitors (SNRIs), focuses on reducing key symptoms and improving quality of life. This review updates and extends the 2013 version of this systematic review.\nObjectives\nTo assess the efficacy, tolerability and safety of serotonin and noradrenaline reuptake inhibitors (SNRIs) compared with placebo or other active drug(s) in the treatment of fibromyalgia in adults.\nSearch methods\nFor this update we searched CENTRAL, MEDLINE, Embase, the US National Institutes of Health and the World Health Organization (WHO) International Clinical Trials Registry Platform for published and ongoing trials and examined the reference lists of reviewed articles, to 8 August 2017.\nSelection criteria\nWe selected randomized, controlled trials of any formulation of SNRIs against placebo or any other active treatment of fibromyalgia in adults.\nData collection and analysis\nThree review authors independently extracted data, examined study quality, and assessed risk of bias. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 50% or greater and of 30% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardized mean differences (SMD) for fatigue, sleep problems, health-related quality of life, mean pain intensity, depression, anxiety, disability, sexual function, cognitive disturbances and tenderness. For tolerability we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawals due to adverse events and for nausea, insomnia and somnolence as specific adverse events. For safety we calculated NNTH for serious adverse events. We undertook meta-analysis using a random-effects model. We assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe added eight new studies with 1979 participants for a total of 18 included studies with 7903 participants. Seven studies investigated duloxetine and nine studies investigated milnacipran against placebo. One study compared desvenlafaxine with placebo and pregabalin. One study compared duloxetine with L-carnitine. The majority of studies were at unclear or high risk of bias in three to five domains.\nThe quality of evidence of all comparisons of desvenlafaxine, duloxetine and milnacipran versus placebo in studies with a parallel design was low due to concerns about publication bias and indirectness, and very low for serious adverse events due to concerns about publication bias, imprecision and indirectness. The quality of evidence of all comparisons of duloxetine and desvenlafaxine with other active drugs was very low due to concerns about publication bias, imprecision and indirectness.\nDuloxetine and milnacipran had no clinically relevant benefit over placebo for pain relief of 50% or greater: 1274 of 4104 (31%) on duloxetine and milnacipran reported pain relief of 50% or greater compared to 591 of 2814 (21%) participants on placebo (risk difference (RD) 0.09, 95% confidence interval (CI) 0.07 to 0.11; NNTB 11, 95% CI 9 to 14). Duloxetine and milnacipran had a clinically relevant benefit over placebo in patient's global impression to be much or very much improved: 888 of 1710 (52%) on duloxetine and milnacipran (RD 0.19, 95% CI 0.12 to 0.26; NNTB 5, 95% CI 4 to 8) reported to be much or very much improved compared to 354 of 1208 (29%) of participants on placebo. Duloxetine and milnacipran had a clinically relevant benefit compared to placebo for pain relief of 30% or greater. RD was 0.10; 95% CI 0.08 to 0.12; NNTB 10, 95% CI 8 to 12. Duloxetine and milnacipran had no clinically relevant benefit for fatigue (SMD -0.13, 95% CI -0.18 to -0.08; NNTB 18, 95% CI 12 to 29), compared to placebo. There were no differences between either duloxetine or milnacipran and placebo in reducing sleep problems (SMD -0.07; 95 % CI -0.15 to 0.01). Duloxetine and milnacipran had no clinically relevant benefit compared to placebo in improving health-related quality of life (SMD -0.20, 95% CI -0.25 to -0.15; NNTB 11, 95% CI 8 to 14).\nThere were 794 of 4166 (19%) participants on SNRIs who dropped out due to adverse events compared to 292 of 2863 (10%) of participants on placebo (RD 0.07, 95% CI 0.04 to 0.10; NNTH 14, 95% CI 10 to 25). There was no difference in serious adverse events between either duloxetine, milnacipran or desvenlafaxine and placebo (RD -0.00, 95% CI -0.01 to 0.00).\nThere was no difference between desvenlafaxine and placebo in efficacy, tolerability and safety in one small trial.\nThere was no difference between duloxetine and desvenlafaxine in efficacy, tolerability and safety in two trials with active comparators (L-carnitine, pregabalin).\nAuthors' conclusions\nThe update did not change the major findings of the previous review. Based on low- to very low-quality evidence, the SNRIs duloxetine and milnacipran provided no clinically relevant benefit over placebo in the frequency of pain relief of 50% or greater, but for patient's global impression to be much or very much improved and in the frequency of pain relief of 30% or greater there was a clinically relevant benefit. The SNRIs duloxetine and milnacipran provided no clinically relevant benefit over placebo in improving health-related quality of life and in reducing fatigue. Duloxetine and milnacipran did not significantly differ from placebo in reducing sleep problems. The dropout rates due to adverse events were higher for duloxetine and milnacipran than for placebo. On average, the potential benefits of duloxetine and milnacipran in fibromyalgia were outweighed by their potential harms. However, a minority of people with fibromyalgia might experience substantial symptom relief without clinically relevant adverse events with duloxetine or milnacipran.\nWe did not find placebo-controlled studies with other SNRIs than desvenlafaxine, duloxetine and milnacipran.\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 fibromyalgia often have chronic (longer than three months) widespread pain, as well as problems with sleep, thinking and exhaustion. They often report poor health-related quality of life. There is no cure for fibromyalgia at present, so the treatments aim to relieve the symptoms and to improve health-related quality of life.\nSerotonin and noradrenaline are chemicals which are produced by the human body, involved in the regulation of pain, sleep and mood. Low concentrations of serotonin have been reported in people with fibromyalgia. Serotonin and noradrenaline reuptake inhibitors (SNRIs) are a class of antidepressants that increase the concentration of serotonin and noradrenaline in the brain."
}
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query-laysum | 4965 | [
{
"role": "user",
"content": "Abstract: Background\nFunctional abdominal pain is pain occurring in the abdomen that cannot be fully explained by another medical condition and is common in children. It has been hypothesised that the use of micro-organisms, such as probiotics and synbiotics (a mixture of probiotics and prebiotics), might change the composition of bacterial colonies in the bowel and reduce inflammation, as well as promote normal gut physiology and reduce functional symptoms.\nObjectives\nTo assess the efficacy and safety of probiotics in the treatment of functional abdominal pain disorders in children.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) and two clinical trials registers from inception to October 2021.\nSelection criteria\nRandomised controlled trials (RCTs) that compare probiotic preparations (including synbiotics) to placebo, no treatment or any other interventional preparation in patients aged between 4 and 18 years of age with a diagnosis of functional abdominal pain disorder according to the Rome II, Rome III or Rome IV criteria.\nData collection and analysis\nThe primary outcomes were treatment success as defined by the primary studies, complete resolution of pain, improvement in the severity of pain and improvement in the frequency of pain. Secondary outcomes included serious adverse events, withdrawal due to adverse events, adverse events, school performance or change in school performance or attendance, social and psychological functioning or change in social and psychological functioning, and quality of life or change in quality life measured using any validated scoring tool. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). For continuous outcomes, we calculated the mean difference (MD) and corresponding 95% CI.\nMain results\nWe included 18 RCTs assessing the effectiveness of probiotics and synbiotics in reducing the severity and frequency of pain, involving a total of 1309 patients.\nProbiotics may achieve more treatment success when compared with placebo at the end of the treatment, with 50% success in the probiotic group versus 33% success in the placebo group (RR 1.57, 95% CI 1.05 to 2.36; 554 participants; 6 studies; I2 = 70%; low-certainty evidence).\nIt is not clear whether probiotics are more effective than placebo for complete resolution of pain, with 42% success in the probiotic group versus 27% success in the placebo group (RR 1.55, 95% CI 0.94 to 2.56; 460 participants; 6 studies; I2 = 70%; very low-certainty evidence). We judged the evidence to be of very low certainty due to high inconsistency and risk of bias.\nWe were unable to draw meaningful conclusions from our meta-analyses of the pain severity and pain frequency outcomes due to very high unexplained heterogeneity leading to very low-certainty evidence.\nNone of the included studies reported serious adverse events. Meta-analysis showed no difference in withdrawals due to adverse events between probiotics (1/275) and placebo (1/269) (RR 1.00, 95% CI 0.07 to 15.12). The results were identical for the total patients with any reported adverse event outcome. However, these results are of very low certainty due to imprecision from the very low numbers of events and risk of bias.\nSynbiotics may result in more treatment success at study end when compared with placebo, with 47% success in the probiotic group versus 35% success in the placebo group (RR 1.34, 95% CI 1.03 to 1.74; 310 participants; 4 studies; I2 = 0%; low certainty). One study used Bifidobacterium coagulans/fructo-oligosaccharide, one used Bifidobacterium lactis/inulin, one used Lactobacillus rhamnosus GG/inulin and in one study this was not stated).\nSynbiotics may result in little difference in complete resolution of pain at study end when compared with placebo, with 52% success in the probiotic group versus 32% success in the placebo group (RR 1.65, 95% CI 0.97 to 2.81; 131 participants; 2 studies; I2 = 18%; low-certainty evidence).\nWe were unable to draw meaningful conclusions from our meta-analyses of pain severity or frequency of pain due to very high unexplained heterogeneity leading to very low-certainty evidence.\nNone of the included studies reported serious adverse events. Meta-analysis showed little to no difference in withdrawals due to adverse events between synbiotics (8/155) and placebo (1/147) (RR 4.58, 95% CI 0.80 to 26.19), or in any reported adverse events (3/96 versus 1/93, RR 2.88, 95% CI 0.32 to 25.92). These results are of very low certainty due to imprecision from the very low numbers of events and risk of bias.\nThere were insufficient data to analyse by subgroups of specific functional abdominal pain syndrome (irritable bowel syndrome, functional dyspepsia, abdominal migraine, functional abdominal pain - not otherwise specified) or by specific strain of probiotic.\nThere was insufficient evidence on school performance or change in school performance/attendance, social and psychological functioning, or quality of life to draw conclusions about the effects of probiotics or synbiotics on these outcomes.\nAuthors' conclusions\nThe results from this review demonstrate that probiotics and synbiotics may be more efficacious than placebo in achieving treatment success, but the evidence is of low certainty. The evidence demonstrates little to no difference between probiotics or synbiotics and placebo in complete resolution of pain. We were unable to draw meaningful conclusions about the impact of probiotics or synbiotics on the frequency and severity of pain as the evidence was all of very low certainty due to significant unexplained heterogeneity or imprecision.\nThere were no reported cases of serious adverse events when using probiotics or synbiotics amongst the included studies, although a review of RCTs may not be the best context to assess long-term safety. The available evidence on adverse effects was of very low certainty and no conclusions could be made in this review. Safety will always be a priority in paediatric populations when considering any treatment. Reporting of all adverse events, adverse events needing withdrawal, serious adverse events and, particularly, long-term safety outcomes are vital to meaningfully move forward the evidence base in this field.\nFurther targeted and appropriately designed RCTs are needed to address the gaps in the evidence base. In particular, appropriate powering of studies to confirm the safety of specific strains not yet investigated and studies to investigate long-term follow-up of patients are both warranted.\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 probiotics and synbiotics can be used for the treatment of functional abdominal pain in children and whether they are safe to use."
}
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query-laysum | 4966 | [
{
"role": "user",
"content": "Abstract: Background\nColchicine is an anti-inflammatory drug that is used for a wide range of inflammatory diseases. Cardiovascular disease also has an inflammatory component but the effects of colchicine on cardiovascular outcomes remain unclear. Previous safety analyses were restricted to specific patient populations.\nObjectives\nTo evaluate potential cardiovascular benefits and harms of a continuous long-term treatment with colchicine in any population, and specifically in people with high cardiovascular risk.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, WHO International Clinical Trials Registry, citations of key papers, and study references in January 2015. We also contacted investigators to gain unpublished data.\nSelection criteria\nRandomised controlled trials (parallel-group or cluster design or first phases of cross-over studies) comparing colchicine over at least six months versus any control in any adult population.\nData collection and analysis\nPrimary outcomes were all-cause mortality, myocardial infarction, and adverse events. Secondary outcomes were cardiovascular mortality, stroke, heart failure, non-scheduled hospitalisations, and non-scheduled cardiovascular interventions. We conducted predefined subgroup analyses, in particular for participants with high cardiovascular risk. .\nMain results\nWe included 39 randomised parallel-group trials with 4992 participants. Colchicine had no effect on all-cause mortality (RR 0.94, 95% CI 0.82 to 1.09; participants = 4174; studies = 30; I² = 27%; moderate quality of evidence). There is uncertainty surrounding the effect of colchicine in reducing cardiovascular mortality (RR 0.34, 95% CI 0.09 to 1.21, I² = 9%; participants = 1132; studies = 7; moderate quality of evidence). Colchicine reduced the risk for total myocardial infarction (RR 0.20, 95% CI 0.07 to 0.57; participants = 652; studies = 2; moderate quality of evidence). There was no effect on total adverse events (RR 1.52, 95% CI 0.93 to 2.46; participants = 1313; studies = 11; I² = 45%; very low quality of evidence) but gastrointestinal intolerance was increased (RR 1.83, 95% CI 1.03 to 3.26; participants = 1258; studies = 11; I² = 74%; low quality of evidence). Colchicine showed no effect on heart failure (RR 0.62, 95% CI 0.10 to 3.88; participants = 462; studies = 3; I² = 45%; low quality of evidence) and no effect on stroke (RR 0.38, 95% CI 0.09 to 1.70; participants = 874; studies = 3; I² = 45%; low quality of evidence). Reporting of serious adverse events was inconsistent; no event occurred over 824 patient-years (4 trials). Effects on other outcomes were very uncertain. Summary effects of RCTs specifically focusing on participants with high cardiovascular risk were similar (4 trials; 1230 participants).\nAuthors' conclusions\nThere is much uncertainty surrounding the benefits and harms of colchicine treatment. Colchicine may have substantial benefits in reducing myocardial infarction in selected high-risk populations but uncertainty about the size of the effect on survival and other cardiovascular outcomes is high, especially in the general population from which most of the studies in our review were drawn. Colchicine is associated with gastrointestinal side effects based on low-quality evidence. More evidence from large-scale randomised trials is needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Colchicine is a very old, inexpensive treatment. It has strong effects against inflammation and is widely used in inflammatory diseases like gout. There are many studies on colchicine in inflammatory diseases. Inflammation is also an important component for the development of heart attacks or strokes. Some recent studies have shown that colchicine may have positive effects on heart disease."
}
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query-laysum | 4967 | [
{
"role": "user",
"content": "Abstract: Background\nPeople experiencing acute psychotic illnesses, especially those associated with agitated or violent behaviour, may require urgent pharmacological tranquillisation or sedation. Droperidol, a butyrophenone antipsychotic, has been used for this purpose in several countries.\nObjectives\nTo estimate the effects of droperidol, including its cost-effectiveness, when compared to placebo, other 'standard' or 'non-standard' treatments, or other forms of management of psychotic illness, in controlling acutely disturbed behaviour and reducing psychotic symptoms in people with schizophrenia-like illnesses.\nSearch methods\nWe updated previous searches by searching the Cochrane Schizophrenia Group Register (18 December 2015). We searched references of all identified studies for further trial citations and contacted authors of trials. We supplemented these electronic searches by handsearching reference lists and contacting both the pharmaceutical industry and relevant authors.\nSelection criteria\nWe included all randomised controlled trials (RCTs) with useable data that compared droperidol to any other treatment for people acutely ill with suspected acute psychotic illnesses, including schizophrenia, schizoaffective disorder, mixed affective disorders, the manic phase of bipolar disorder or a brief psychotic episode.\nData collection and analysis\nFor included studies, we assessed quality, risk of bias and extracted data. We excluded data when more than 50% of participants were lost to follow-up. For binary outcomes, we calculated standard estimates of risk ratio (RR) and the corresponding 95% confidence intervals (CI). We created a 'Summary of findings' table using GRADE.\nMain results\nWe identified four relevant trials from the update search (previous version of this review included only two trials). When droperidol was compared with placebo, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 227, RR 1.18, 95% CI 1.05 to 1.31, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for the droperidol group (1 RCT, N = 227, RR 0.55, 95% CI 0.36 to 0.85, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 227, RR 0.34, 95% CI 0.01 to 8.31, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 227, RR 0.62, 95% CI 0.15 to 2.52, low-quality evidence) than placebo. For 'being ready for discharge', there was no clear difference between groups (1 RCT, N = 227, RR 1.16, 95% CI 0.90 to 1.48, high-quality evidence). There were no data for mental state and costs.\nSimilarly, when droperidol was compared to haloperidol, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 228, RR 1.01, 95% CI 0.93 to 1.09, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for participants in the droperidol group (2 RCTs, N = 255, RR 0.37, 95% CI 0.16 to 0.90, high-quality evidence). There was no evidence that droperidol caused more cardiovascular hypotension (1 RCT, N = 228, RR 2.80, 95% CI 0.30 to 26.49,moderate-quality evidence) and cardiovascular hypotension/desaturation (1 RCT, N = 228, RR 2.80, 95% CI 0.12 to 67.98, low-quality evidence) than haloperidol. There was no suggestion that use of droperidol was unsafe. For mental state, there was no evidence of clear difference between the efficacy of droperidol compared to haloperidol (Scale for Quantification of Psychotic Symptom Severity, 1 RCT, N = 40, mean difference (MD) 0.11, 95% CI -0.07 to 0.29, low-quality evidence). There were no data for service use and costs.\nWhereas, when droperidol was compared with midazolam, for the outcome of tranquillisation or asleep by 30 minutes we found droperidol to be less acutely tranquillising than midazolam (1 RCT, N = 153, RR 0.96, 95% CI 0.72 to 1.28, high-quality evidence). As regards the 'need for additional medication by 60 minutes after initial adequate sedation, we found an effect (1 RCT, N = 153, RR 0.54, 95% CI 0.24 to 1.20, moderate-quality evidence). In terms of adverse effects, we found no statistically significant differences between the two drugs for either airway obstruction (1 RCT, N = 153, RR 0.13, 95% CI 0.01 to 2.55, low-quality evidence) or respiratory hypoxia (1 RCT, N = 153, RR 0.70, 95% CI 0.16 to 3.03, moderate-quality evidence) - but use of midazolam did result in three people (out of around 70) needing some sort of 'airway management' with no such events in the droperidol group. There were no data for mental state, service use and costs.\nFurthermore, when droperidol was compared to olanzapine, for the outcome of tranquillisation or asleep by any time point, we found no clear differences between the older drug (droperidol) and olanzapine (e.g. at 30 minutes: 1 RCT, N = 221, RR 1.02, 95% CI 0.94 to 1.11, high-quality evidence). There was a suggestion that participants allocated droperidol needed less additional medication after 60 minutes than people given the olanzapine (1 RCT, N = 221, RR 0.56, 95% CI 0.36 to 0.87, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 221, RR 0.32, 95% CI 0.01 to 7.88, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 221, RR 0.97, 95% CI 0.20 to 4.72, low-quality evidence) than olanzapine. For 'being ready for discharge', there was no difference between groups (1 RCT, N = 221, RR 1.06, 95% CI 0.83 to 1.34, high-quality evidence). There were no data for mental state and costs.\nAuthors' conclusions\nPreviously, the use of droperidol was justified based on experience rather than evidence from well-conducted and reported randomised trials. However, this update found high-quality evidence with minimal risk of bias to support the use of droperidol for acute psychosis. Also, we found no evidence to suggest that droperidol should not be a treatment option for people acutely ill and disturbed because of serious mental illnesses.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Compared to placebo, droperidol was more effective at tranquillising agitated participants 30 minutes after taking it. Similar results were found for tranquillisation when droperidol was compared with haloperidol but this effect was less clear, and not evident when droperidol was compared to midazolam or olanzapine. Droperidol did not cause more side effects than the other drugs in the studies. The studies did not look at costs."
}
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query-laysum | 4968 | [
{
"role": "user",
"content": "Abstract: Background\nFibroids are common benign tumours arising in the uterus. Myomectomy is the surgical treatment of choice for women with symptomatic fibroids who prefer or want uterine conservation. Myomectomy can be performed by conventional laparotomy, by mini-laparotomy or by minimal access techniques such as hysteroscopy and laparoscopy.\nObjectives\nTo determine the benefits and harms of laparoscopic or hysteroscopic myomectomy compared with open myomectomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (inception to July 2014), the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of Controlled Trials (inception to July 2014), MEDLINE(R) (inception to July 2014), EMBASE (inception to July 2014), PsycINFO (inception to July 2014) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (inception to July 2014) to identify relevant randomised controlled trials (RCTs). We also searched trial registers and references from selected relevant trials and review articles. We applied no language restriction in these searches.\nSelection criteria\nAll published and unpublished randomised controlled trials comparing myomectomy via laparotomy, mini-laparotomy or laparoscopically assisted mini-laparotomy versus laparoscopy or hysteroscopy in premenopausal women with uterine fibroids diagnosed by clinical and ultrasound examination were included in the meta-analysis.\nData collection and analysis\nWe conducted study selection and extracted data in duplicate. Primary outcomes were postoperative pain, reported in six studies, and in-hospital adverse events, reported in eight studies. Secondary outcomes included length of hospital stay, reported in four studies, operating time, reported in eight studies and recurrence of fibroids, reported in three studies. Each of the other secondary outcomes—improvement in menstrual symptoms, change in quality of life, repeat myomectomy and hysterectomy at a later date—was reported in a single study. Odds ratios (ORs), mean differences (MDs) and 95% confidence intervals (CIs) were calculated and data combined using the fixed-effect model. The quality of evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods.\nMain results\nWe found 23 potentially relevant trials, of which nine were eligible for inclusion in this review. The nine trials included in our meta-analysis had a total of 808 women. The overall risk of bias of included studies was low, as most studies properly reported their methods.\nPostoperative pain: Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Postoperative pain was significantly less, as determined by subjectively assessed pain score at six hours (MD -2.40, 95% CI -2.88 to -1.92, one study, 148 women, moderate-quality evidence) and 48 hours postoperatively (MD -1.90, 95% CI -2.80 to -1.00, two studies, 80 women, I² = 0%, moderate-quality evidence) in the laparoscopic myomectomy group compared with the open myomectomy group. This means that among women undergoing laparoscopic myomectomy, mean pain score at six hours and 48 hours would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. No significant difference in postoperative pain score was noted between the laparoscopic and open myomectomy groups at 24 hours (MD -0.29, 95% CI -0.7 to 0.12, four studies, 232 women, I² = 43%, moderate-quality evidence). The overall quality of these findings is moderate; therefore further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.\nIn-hospital adverse events: No evidence suggested a difference in unscheduled return to theatre (OR 3.04, 95% CI 0.12 to 75.86, two studies, 188 women, I² = 0%, low-quality evidence) and laparoconversion (OR 1.11, 95% CI 0.44 to 2.83, eight studies, 756 women, I² = 53%, moderate-quality evidence) when open myomectomy was compared with laparoscopic myomectomy. Only one study including 148 women reported injury to pelvic organs (no events were described in other studies), and no significant difference was noted between laparoscopic myomectomy and laparoscopically assisted mini-laparotomy myomectomy (OR 3.04, 95% CI 0.12 to 75.86). Significantly lower risk of postoperative fever was observed in the laparoscopic myomectomy group compared with groups treated with all types of open myomectomy (OR 0.44, 95% CI 0.26 to 0.77, I² = 0%, six studies, 635 women). This indicates that among women undergoing laparoscopic myomectomy, the risk of postoperative fever is 50% lower than among those treated with open surgery. No studies reported immediate hysterectomy, uterine rupture, thromboembolism or mortality. Six studies including 549 women reported haemoglobin drop, but these studies were not pooled because of extreme heterogeneity (I² = 97%) and therefore could not be included in the analysis.\nAuthors' conclusions\nLaparoscopic myomectomy is a procedure associated with less subjectively reported postoperative pain, lower postoperative fever and shorter hospital stay compared with all types of open myomectomy. No evidence suggested a difference in recurrence risk between laparoscopic and open myomectomy. More studies are needed to assess rates of uterine rupture, occurrence of thromboembolism, need for repeat myomectomy and hysterectomy at a later stage.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence ranged from very low to moderate. Some outcomes involved small numbers of participants, poor information about blinding in included studies and very wide confidence intervals."
}
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query-laysum | 4969 | [
{
"role": "user",
"content": "Abstract: Background\nChronic venous insufficiency (CVI) is a condition related to chronic venous disease that may progress to venous leg ulceration and impair quality of life of those affected. Treatments such as physical exercise may be useful to reduce CVI symptoms. This is an update of an earlier Cochrane Review.\nObjectives\nTo evaluate the benefits and harms of physical exercise programmes for the treatment of individuals with non-ulcerated CVI.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 28 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing exercise programmes with no exercise in people with non-ulcerated CVI.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were intensity of disease signs and symptoms, ejection fraction, venous refilling time, and incidence of venous leg ulcer. Our secondary outcomes were quality of life, exercise capacity, muscle strength, incidence of surgical intervention, and ankle joint mobility. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included five RCTs involving 146 participants. The studies compared a physical exercise group with a control group that did not perform a structured exercise programme. The exercise protocols differed between studies. We assessed three studies to be at an overall unclear risk of bias, one study at overall high risk of bias, and one study at overall low risk of bias. We were not able to combine data in meta-analysis as studies did not report all outcomes, and different methods were used to measure and report outcomes.\nTwo studies reported intensity of CVI disease signs and symptoms using a validated scale. There was no clear difference in signs and symptoms between groups in baseline to six months after treatment (Venous Clinical Severity Score mean difference (MD) −0.38, 95% confidence interval (CI) −3.02 to 2.26; 28 participants, 1 study; very low-certainty evidence), and we are uncertain if exercise alters the intensity of signs and symptoms eight weeks after treatment (MD −4.07, 95% CI −6.53 to −1.61; 21 participants, 1 study; very low-certainty evidence).\nThere was no clear difference in ejection fraction between groups from baseline to six months follow-up (MD 4.88, 95% CI −1.82 to 11.58; 28 participants, 1 study; very low-certainty evidence).\nThree studies reported on venous refilling time. We are uncertain if there is an improvement in venous refilling time between groups for baseline to six-month changes (MD 10.70 seconds, 95% CI 8.86 to 12.54; 23 participants, 1 study; very low-certainty evidence) or baseline to eight-week change (MD 9.15 seconds, 95% CI 5.53 to 12.77 for right side; MD 7.25 seconds, 95% CI 5.23 to 9.27 for left side; 21 participants, 1 study; very low-certainty evidence). There was no clear difference in venous refilling index for baseline to six-month changes (MD 0.57 mL/min, 95% CI −0.96 to 2.10; 28 participants, 1 study; very low-certainty evidence).\nNo included studies reported the incidence of venous leg ulcers.\nOne study reported health-related quality of life using validated instruments (Venous Insufficiency Epidemiological and Economic Study (VEINES) and 36-item Short Form Health Survey (SF-36), physical component score (PCS) and mental component score (MCS)). We are uncertain if exercise alters baseline to six-month changes in health-related quality of life between groups (VEINES-QOL: MD 4.60, 95% CI 0.78 to 8.42; SF-36 PCS: MD 5.40, 95% CI 0.63 to 10.17; SF-36 MCS: MD 0.40, 95% CI −3.85 to 4.65; 40 participants, 1 study; all very low-certainty evidence). Another study used the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), and we are uncertain if exercise alters baseline to eight-week changes in health-related quality of life between groups (MD 39.36, 95% CI 30.18 to 48.54; 21 participants, 1 study; very low-certainty evidence). One study reported no differences between groups without presenting data.\nThere was no clear difference between groups in exercise capacity measured as time on treadmill (baseline to six-month changes) (MD −0.53 minutes, 95% CI −5.25 to 4.19; 35 participants, 1 study; very low-certainty evidence). We are uncertain if exercise improves exercise capacity as assessed by the 6-minute walking test (MD 77.74 metres, 95% CI 58.93 to 96.55; 21 participants, 1 study; very low-certainty evidence).\nMuscle strength was measured using dynamometry or using heel lifts counts. We are uncertain if exercise increases peak torque/body weight (120 revolutions per minute) (changes from baseline to six months MD 3.10 ft-lb, 95% CI 0.98 to 5.22; 29 participants, 1 study; very low-certainty evidence). There was no clear difference between groups in baseline to eight-week change in strength measured by a hand dynamometer (MD 12.24 lb, 95% CI −7.61 to 32.09 for the right side; MD 11.25, 95% CI −14.10 to 36.60 for the left side; 21 participants, 1 study; very low-certainty evidence). We are uncertain if there is an increase in heel lifts (n) (baseline to six-month changes) between groups (MD 7.70, 95% CI 0.94 to 14.46; 39 participants, 1 study; very low-certainty evidence).\nThere was no clear difference between groups in ankle mobility measured during dynamometry (baseline to six-month change MD −1.40 degrees, 95% CI −4.77 to 1.97; 29 participants, 1 study; very low-certainty evidence). We are uncertain if exercise increases plantar flexion measured by a goniometer (baseline to eight-week change MD 12.13 degrees, 95% CI 8.28 to 15.98 for right leg; MD 10.95 degrees, 95% CI 7.93 to 13.97 for left leg; 21 participants, 1 study; very low-certainty evidence). In all cases, we downgraded the certainty of evidence due to risk of bias and imprecision.\nAuthors' conclusions\nThere is currently insufficient evidence to assess the benefits and harms of physical exercise in people with chronic venous disease. Future research into the effect of physical exercise should consider types of exercise protocols (intensity, frequency, and time), sample size, blinding, and homogeneity according to the severity of disease.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to 28 March 2022."
}
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query-laysum | 4970 | [
{
"role": "user",
"content": "Abstract: Background\nPhototherapy is a well-established effective therapy for treating babies with significant neonatal jaundice. Studies have shown that increasing light intensity will increase its efficiency. A potentially inexpensive and easy way of increasing the intensity of light on the body of the infant may be to hang reflective materials from the sides of phototherapy units.\nObjectives\nTo assess the effects of reflective materials in combination with phototherapy compared with phototherapy alone for unconjugated hyperbilirubinaemia in neonates.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index of Nursing and Allied Health Literature (CINAHL), on 1 November 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials if the participants, who were term or preterm infants, received phototherapy with curtains made of reflective materials of any type in the treatment arm, and if those in the comparison arm received similar phototherapy without curtains or other intensified phototherapy, such as a double bank of lights.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence.\nMain results\nOf 15 studies identified, we included 12 (1288 babies) in the review - 11 comparing phototherapy with reflective materials and phototherapy alone, and one comparing a single phototherapy light bank with reflective materials with double phototherapy. All reflective materials consisted of curtains on three or four sides of the cot and were made of white plastic (five studies), white linen (two studies), or aluminium (three studies); materials were not specified in two studies. Only 11 studies (10 comparing reflective materials versus none and one comparing reflective curtains and a single bank of lights with a double (above and below) phototherapy unit) provided sufficient data to be included in the meta-analysis. Two excluded studies used the reflective materials in a way that did not meet our inclusion criteria, and we excluded one study because it compared four different phototherapy interventions not including reflective materials. The risk of bias of included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention.\nThree studies (281 participants) reported a decline in serum bilirubin (SB) (μmol/L) at four to eight hours (mean difference (MD) -14.61, 95% confidence interval (CI) -19.80 to -9.42; I² = 57%; moderate-certainty evidence). Nine studies (893 participants) reported a decline in SB over 24 hours and showed a faster decline in SB in the intervention group, but heterogeneity (I² = 97%) was too substantial to permit a meaningful estimate of the actual effect size (very low-certainty evidence). Subgroup analysis by type of reflective material used did not explain the heterogeneity. Exchange transfusion was reported by two studies; both reported none in either group. Four studies (466 participants) reported the mean duration of phototherapy, and in each of these studies, it was reduced in the intervention group but there was substantial heterogeneity (I² = 88%), precluding meaningful meta-analysis of data. The only two studies that reported the mean duration of hospital stay in hours showed a meaningful reduction (MD -41.08, 95% CI -45.92 to -36.25; I² = 0; moderate-certainty evidence).\nNo studies reported costs of the intervention, parental or medical staff satisfaction, breastfeeding outcomes, or neurodevelopmental follow-up.\nThe only study that compared use of curtains with double phototherapy reported similar results for both groups.\nStudies that monitored adverse events did not report increased adverse events related to the use of curtains, including acute life-threatening events, but other rarer side effects could not be excluded.\nAuthors' conclusions\nModerate-certainty evidence shows that the use of reflective curtains during phototherapy may result in greater decline in SB. Very low-certainty evidence suggests that the duration of phototherapy is reduced, and moderate-certainty evidence shows that the duration of hospital stay is also reduced. Available evidence does not show any increase in adverse events, but further studies are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Jaundice (yellow discolouration of the skin) occurs in up to 60% of babies. This is due to accumulation of bilirubin. Mild elevations in bilirubin are considered normal, but when levels are very high, bilirubin could enter the brain and cause brain damage. Treatment using age- and risk-specific guidelines is aimed at preventing bilirubin from reaching these levels. Phototherapy (exposing the body to light of a specific wavelength) is the usual treatment, and the intensity of light on the skin is one of the factors determining the rate of decline in bilirubin. A potentially inexpensive method to increase the intensity of light is to use reflective materials. One of the concerns is that these curtains might obscure the view of the baby."
}
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query-laysum | 4971 | [
{
"role": "user",
"content": "Abstract: Background\nImmunisation is a powerful public health strategy for improving child survival, not only by directly combating key diseases that kill children but also by providing a platform for other health services. However, each year millions of children worldwide, mostly from low- and middle-income countries (LMICs), do not receive the full series of vaccines on their national routine immunisation schedule. This is an update of the Cochrane review published in 2011 and focuses on interventions for improving childhood immunisation coverage in LMICs.\nObjectives\nTo evaluate the effectiveness of intervention strategies to boost and sustain high childhood immunisation coverage in LMICs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2016, Issue 4, part of The Cochrane Library. www.cochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 12 May 2016); MEDLINE In-Process and Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 12 May 2016); CINAHL 1981 to present, EbscoHost (searched 12 May 2016); Embase 1980 to 2014 Week 34, OvidSP (searched 2 September 2014); LILACS, VHL (searched 2 September 2014); Sociological Abstracts 1952 - current, ProQuest (searched 2 September 2014). We did a citation search for all included studies in Science Citation Index and Social Sciences Citation Index, 1975 to present; Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 2 July 2016). We also searched the two Trials Registries: ICTRP and ClinicalTrials.gov (searched 5 July 2016)\nSelection criteria\nEligible studies were randomised controlled trials (RCT), non-RCTs, controlled before-after studies, and interrupted time series conducted in LMICs involving children aged from birth to four years, caregivers, and healthcare providers.\nData collection and analysis\nWe independently screened the search output, reviewed full texts of potentially eligible articles, assessed risk of bias, and extracted data in duplicate; resolving discrepancies by consensus. We then conducted random-effects meta-analyses and used GRADE to assess the certainty of evidence.\nMain results\nFourteen studies (10 cluster RCTs and four individual RCTs) met our inclusion criteria. These were conducted in Georgia (one study), Ghana (one study), Honduras (one study), India (two studies), Mali (one study), Mexico (one study), Nicaragua (one study), Nepal (one study), Pakistan (four studies), and Zimbabwe (one study). One study had an unclear risk of bias, and 13 had high risk of bias. The interventions evaluated in the studies included community-based health education (three studies), facility-based health education (three studies), household incentives (three studies), regular immunisation outreach sessions (one study), home visits (one study), supportive supervision (one study), information campaigns (one study), and integration of immunisation services with intermittent preventive treatment of malaria (one study).\nWe found moderate-certainty evidence that health education at village meetings or at home probably improves coverage with three doses of diphtheria-tetanus-pertussis vaccines (DTP3: risk ratio (RR) 1.68, 95% confidence interval (CI) 1.09 to 2.59). We also found low-certainty evidence that facility-based health education plus redesigned vaccination reminder cards may improve DTP3 coverage (RR 1.50, 95% CI 1.21 to 1.87). Household monetary incentives may have little or no effect on full immunisation coverage (RR 1.05, 95% CI 0.90 to 1.23, low-certainty evidence). Regular immunisation outreach may improve full immunisation coverage (RR 3.09, 95% CI 1.69 to 5.67, low-certainty evidence) which may substantially improve if combined with household incentives (RR 6.66, 95% CI 3.93 to 11.28, low-certainty evidence). Home visits to identify non-vaccinated children and refer them to health clinics may improve uptake of three doses of oral polio vaccine (RR 1.22, 95% CI 1.07 to 1.39, low-certainty evidence). There was low-certainty evidence that integration of immunisation with other services may improve DTP3 coverage (RR 1.92, 95% CI 1.42 to 2.59).\nAuthors' conclusions\nProviding parents and other community members with information on immunisation, health education at facilities in combination with redesigned immunisation reminder cards, regular immunisation outreach with and without household incentives, home visits, and integration of immunisation with other services may improve childhood immunisation coverage in LMIC. Most of the evidence was of low certainty, which implies a high likelihood that the true effect of the interventions will be substantially different. There is thus a need for further well-conducted RCTs to assess the effects of interventions for improving childhood immunisation coverage in LMICs.\n\nGiven the provided abstract, please respond to the following query: \"Do strategies to improve childhood vaccination work?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Giving information about vaccination to parents and community members, handing out specially designed vaccination reminder cards, offering vaccines through regular immunisation outreach with and without household incentives (rewards), identifying unvaccinated children through home visits and referring them to health clinics, and integrating vaccination services with other services may lead to more children getting vaccinated. However, offering parents money to vaccinate their children may not improve vaccination uptake. Most of these findings were of low-certainty, and we need more well-conducted research in this area."
}
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query-laysum | 4972 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovary syndrome (PCOS) is a common endocrine condition, affecting approximately one in 10 women. PCOS is defined by two of three features: oligo- or anovulation, clinical or biochemical hyperandrogenism or both, or polycystic ovaries.\nWomen with PCOS can have a wide range of health problems, including infrequent and irregular periods, unwanted hair growth and acne, and subnormal fertility. Long-term health concerns include an increased risk of heart disease, diabetes and the development of precancerous disease of the womb.\nObjectives\nTo assess the effectiveness and harms of ovarian surgery as a treatment for symptomatic relief of hirsutism, acne and menstrual irregularity in PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group specialized register, CENTRAL, MEDLINE, Embase and PsycINFO (from inception to 17 October 2016). We handsearched citation lists, registers of ongoing trials and conference proceedings.\nSelection criteria\nWe included randomized controlled trials (RCTs) of women undergoing ovarian drilling in comparison to no treatment, medical treatment, or other forms of surgical treatment for the symptoms of PCOS.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary outcome measures were improvement in menstrual regularity and androgenic symptoms of PCOS (hirsutism, acne); the secondary outcome measures included harms, change of body mass index (BMI), waist circumference, androgen levels, metabolic measures and quality of life. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe included 22 RCTs (2278 women analyzed) of participants with PCOS and symptoms of acne, hirsutism or irregular menstrual cycles, all of which included laparoscopic ovarian drilling (LOD) as an intervention.\nTwo studies reported their funding source (Farquhar 2002 - supported in part by the Auckland Medical Research Foundation; Sarouri 2015 - the authors thank the Vice Chancellor for Research of Guilan University of Medical Sciences for funding this project).\nThe quality of the evidence ranged from very low to moderate quality. The main limitations were imprecision associated with the low number of studies, inconsistency and risk of bias associated with the inability to blind participants. There were too few studies to assess risk of publication bias.\nMenstrual Regularity\nTwo studies compared LOD versus metformin (n=226) but no conclusions could be drawn with regard to menstrual regularity, as their findings were inconsistent and they were unsuitable for pooling. There appeared to be little or no difference in the rate of women reporting improvement in menstrual regularity when LOD was compared with medical treatment including metformin + clomiphene (OR 1.02, 95% CI 0.64 to 1.64, 2 studies, 332 women, I2 = 13%, low-quality evidence), letrozole (OR 1.08, 95% CI 0.64 to 1.84, 1 study, 260 women, low-quality evidence), or metformin + letrozole (OR 0.95, 95% CI 0.49 to 1.81, 1 study, 146 women, low-quality evidence). However, one study reported that LOD was superior to gonadotrophin (OR 19.2, 95% CI 3.17 to 116.45, 1 study, 35 women, very low-quality evidence).\nThere appeared to be little or no difference in the rate of women reporting improvement in menstrual regularity when bilateral unipolar LOD was compared to unilateral LOD (OR 1.51, 95% CI 0.62 to 3.71, 2 studies, 104 women, I2 = 0%, moderate-quality evidence), transvaginal ultrasound-guided LOD (OR 1.23, 95% CI 0.64 to 2.37, 1 study, 147 women, low-quality evidence), LOD using adjusted thermal dose in accordance with the ovarian volume (OR 0.42, 95% CI 0.16 to 1.14, 1 study, 115 women, low-quality evidence) or bipolar LOD (OR 1.00, 95% CI 0.05 to 18.57, 1 study, 18 women, low-quality evidence).\nFour to five punctures per ovary may improve the rate of women reporting menstrual regularity compared with two or fewer (OR 16.04, 95% CI 4.19 to 61.34, 2 studies, 73 women, I2 = 0%, low-quality evidence).\nAndrogenic Symptoms\nThere was probably little or no difference in improvement in androgenic symptoms when LOD was compared to metformin (OR 1.00, 95% CI 0.42 to 2.37, 1 study, 126 women, moderate-quality evidence) or gonadotrophins; acne (OR 3.20, 95% CI 0.33 to 30.94, 1 study, 25 women, low-quality evidence), hirsutism (OR 2.31, 95% CI 0.22 to 23.89, 1 study, 25 women, low-quality evidence).\nThere appeared to be little or no difference in improvement of androgenic symptoms when LOD was compared to transvaginal ultrasound-guided LOD, with respect to hirsutism (OR 1.09, 95% CI 0.30 to 3.91, 1 study, 39 women, low-quality evidence) or acne (OR 0.84, 95% CI 0.20 to 3.50, 1 study, 31 women, low-quality evidence).\nHarms\nLOD was associated with fewer gastrointestinal side effects than metformin plus clomiphene (OR 0.05, 95% CI 0.01 to 0.36, 2 studies, 332 women, I2 = 0%, moderate-quality evidence). One study suggested little or no difference in rates of ovarian hyperstimulation syndrome between LOD and gonadotrophins (OR 0.08, 95% CI 0.00 to 1.61, 1 study, 33 women, low-quality evidence).\nThere were fewer adhesions with transvaginal hydrolaparoscopy compared to LOD (OR 0.10, 95% CI 0.05 to 0.18, 1 study, 246 women, moderate-quality evidence). There appeared to be little or no difference in adhesions when variable energy LOD was compared with standard LOD (OR 0.96, 95% CI 0.32 to 2.88, 1 study, 64 women, low-quality evidence). Another study (44 women) reported that none of the women who returned for surgery following either traditional or unilateral LOD were found to have adhesions.\nAuthors' conclusions\nThere was no clear evidence that LOD improves menstrual regularity or the androgenic symptoms of PCOS, compared to most of the medical treatments used in the included studies. LOD was associated with fewer gastrointestinal side effects compared to metformin and clomiphene.\nThere was also no clear evidence of different effectiveness between types of LOD, except that LOD with four to five punctures per ovary may be more effective than two or fewer punctures. There was little evidence comparing LOD with different types of surgery, although one study concluded that transvaginal hydrolaparoscopy had a lower risk of adhesions than LOD.\nThere was evidence from one small study of benefit from LOD compared to gonadotrophins for menstrual regulation. However, gonadotrophins are seldom used for this indication.\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": "LOD may be better at regulating menstrual cycles than gonadotrophins. However, most doctors would consider other options for first-line treatment. LOD with four or five drill holes versus two or fewer per ovary may be more effective at menstrual regulation in women with PCOS.\nThere was not enough evidence to tell whether there is a difference between LOD and other medical treatment or variations in surgical technique in improving the regularity of periods or androgenic symptoms.\nLOD was associated with fewer gastrointestinal side effects compared to metformin and clomiphene, but involves surgery and is not standard treatment for menstrual disturbance or unwanted hair growth. There was less scar tissue with transvaginal hydrolaparoscopy compared to LOD.\nOverall LOD can be considered to have a low risk of harm, and to be an option in the management of symptoms of PCOS."
}
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query-laysum | 4973 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is one of the most common psychiatric conditions affecting children and adolescents. Amphetamines are among the most commonly prescribed medications to manage ADHD. There are three main classes of amphetamines: dexamphetamine, lisdexamphetamine and mixed amphetamine salts, which can be further broken down into short- and long-acting formulations. A systematic review assessing their efficacy and safety in this population has never been conducted.\nObjectives\nTo assess the efficacy and safety of amphetamines for ADHD in children and adolescents.\nSearch methods\nIn August 2015 we searched CENTRAL, Ovid MEDLINE, Embase, PsycINFO, ProQuest Dissertation and Theses, and the Networked Digital Library of Theses and Dissertations. We also searched ClinicalTrials.gov, and checked the reference lists of relevant studies and reviews identified by the searches. No language or date restrictions were applied.\nSelection criteria\nParallel-group and cross-over randomized controlled trials (RCTs) comparing amphetamine derivatives against placebo in a pediatric population (< 18 years) with ADHD.\nData collection and analysis\nTwo authors independently extracted data on participants, settings, interventions, methodology, and outcomes for each included study. For continuous outcomes, we calculated the standardized mean difference (SMD) and for dichotomous outcomes we calculated the risk ratio (RR). Where possible, we conducted meta-analyses using a random-effects model. We also performed a meta-analysis of the most commonly reported adverse events in the primary studies.\nMain results\nWe included 23 trials (8 parallel-group and 15 cross-over trials), with 2675 children aged three years to 17 years. All studies compared amphetamines to placebo. Study durations ranged from 14 days to 365 days, with the majority lasting less than six months. Most studies were conducted in the United States; three studies were conducted across Europe. We judged 11 included studies to be at a high risk of bias due to insufficient blinding methods, failing to account for dropouts and exclusions from the analysis, and failing to report on all outcomes defined a priori. We judged the remaining 12 studies to be at unclear risk of bias due to inadequate reporting.\nAmphetamines improved total ADHD core symptom severity according to parent ratings (SMD -0.57; 95% confidence interval (CI) -0.86 to -0.27; 7 studies; 1247 children/adolescents; very low quality evidence), teacher ratings (SMD -0.55; 95% CI -0.83 to -0.27; 5 studies; 745 children/adolescents; low quality evidence), and clinician ratings (SMD -0.84; 95% CI -1.32 to -0.36; 3 studies; 813 children/adolescents; very low quality evidence). In addition, the proportion of responders as rated by the Clinical Global Impression - Improvement (CGI-I) scale was higher when children were taking amphetamines (RR 3.36; 95% CI 2.48 to 4.55; 9 studies; 2207 children/adolescents; very low quality evidence).\nThe most commonly reported adverse events included decreased appetite, insomnia/trouble sleeping, abdominal pain, nausea/vomiting, headaches, and anxiety. Amphetamines were associated with a higher proportion of participants experiencing decreased appetite (RR 6.31; 95% CI 2.58 to 15.46; 11 studies; 2467 children/adolescents), insomnia (RR 3.80; 95% CI 2.12 to 6.83; 10 studies; 2429 children/adolescents), and abdominal pain (RR 1.44; 95% CI 1.03 to 2.00; 10 studies; 2155 children/adolescents). In addition, the proportion of children who experienced at least one adverse event was higher in the amphetamine group (RR 1.30; 95% CI 1.18 to 1.44; 6 studies; 1742 children/adolescents; low quality evidence).\nWe performed subgroup analyses for amphetamine preparation (dexamphetamine, lisdexamphetamine, mixed amphetamine salts), amphetamine release formulation (long acting versus short acting), and funding source (industry versus non industry). Between-group differences were observed for proportion of participants experiencing decreased appetite in both the amphetamine preparation (P < 0.00001) and amphetamine release formulation (P value = 0.008) subgroups, as well as for retention in the amphetamine release formulation subgroup (P value = 0.03).\nAuthors' conclusions\nMost of the included studies were at high risk of bias and the overall quality of the evidence ranged from low to very low on most outcomes. Although amphetamines seem efficacious at reducing the core symptoms of ADHD in the short term, they were associated with a number of adverse events. This review found no evidence that supports any one amphetamine derivative over another, and does not reveal any differences between long-acting and short-acting amphetamine preparations. Future trials should be longer in duration (i.e. more than 12 months), include more psychosocial outcomes (e.g. quality of life and parent stress), and be transparently reported.\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": "Attention deficit hyperactivity disorder (ADHD) is a common problem affecting children and adolescents. ADHD is characterized by inattention (being easily distracted, unable to focus on one task), impulsivity (fidgety; constantly moving), and hyperactivity (impatient; acts without thinking). One of the most common treatments for managing ADHD is the drug class of amphetamines, which are a class of stimulant medications. They are thought to reduce the severity of symptoms associated with ADHD."
}
]
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query-laysum | 4974 | [
{
"role": "user",
"content": "Abstract: Background\nSome dental implant failures may be due to bacterial contamination at implant insertion. Infections around biomaterials are difficult to treat, and almost all infected implants have to be removed. In general, antibiotic prophylaxis in surgery is only indicated for patients at risk of infectious endocarditis; with reduced host-response; when surgery is performed in infected sites; in cases of extensive and prolonged surgical interventions; and when large foreign materials are implanted. A variety of prophylactic systemic antibiotic regimens have been suggested to minimise infections after dental implant placement. More recent protocols recommended short-term prophylaxis, if antibiotics have to be used. Adverse events may occur with the administration of antibiotics, and can range from diarrhoea to life-threatening allergic reactions. Another major concern associated with the widespread use of antibiotics is the selection of antibiotic-resistant bacteria. The use of prophylactic antibiotics in implant dentistry is controversial.\nObjectives\nTo assess the beneficial or harmful effects of systemic prophylactic antibiotics at dental implant placement versus no antibiotic or placebo administration and, if antibiotics are beneficial, to determine which type, dosage and duration is the most effective.\nSearch methods\nWe searched the Cochrane Oral Health's Trials Register (to 17 June 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 5), MEDLINE via OVID (1946 to 17 June 2013) and EMBASE via OVID (1980 to 17 June 2013). There were no language or date restrictions placed on the searches of the electronic databases.\nSelection criteria\nRandomised controlled clinical trials (RCTs) with a follow-up of at least three months, that compared the administration of various prophylactic antibiotic regimens versus no antibiotics to people undergoing dental implant placement. Outcome measures included prosthesis failures, implant failures, postoperative infections and adverse events (gastrointestinal, hypersensitivity, etc).\nData collection and analysis\nScreening of eligible studies, assessment of the risk of bias of the trials and data extraction were conducted in duplicate and independently by two review authors. Results were expressed as risk ratios (RRs) using a random-effects model for dichotomous outcomes with 95% confidence intervals (CIs). Heterogeneity, including both clinical and methodological factors, was to be investigated.\nMain results\nSix RCTs with 1162 participants were included: three trials compared 2 g of preoperative amoxicillin versus placebo (927 participants), one compared 3 g of preoperative amoxicillin versus placebo (55 participants), one compared 1 g of preoperative amoxicillin plus 500 mg four times a day for two days versus no antibiotics (80 participants), and one compared four groups: (1) 2 g of preoperative amoxicillin; (2) 2 g of preoperative amoxicillin plus 1 g twice a day for seven days; (3) 1 g of postoperative amoxicillin twice a day for seven days, and (4) no antibiotics (100 participants). The overall body of evidence was considered to be of moderate quality. The meta-analyses of the six trials showed a statistically significant higher number of participants experiencing implant failures in the group not receiving antibiotics (RR 0.33; 95% CI 0.16 to 0.67, P value 0.002, heterogeneity: Tau2 0.00; Chi2 2.87, df = 5 (P value 0.57); I2 0%). The number needed to treat for one additional beneficial outcome (NNTB) to prevent one person having an implant failure is 25 (95% CI 14 to 100), based on an implant failure rate of 6% in participants not receiving antibiotics. There was borderline statistical significance for prosthesis failures (RR 0.44; 95% CI 0.19 to 1.00), with no statistically significant differences for infections (RR 0.69; 95% CI 0.36 to 1.35), or adverse events (RR 1; 95% CI 0.06 to 15.85) (only two minor adverse events were recorded, one in the placebo group). No conclusive information can be derived from the only trial that compared three different durations of antibiotic prophylaxis since no event (implant/prosthesis failures, infections or adverse events) occurred in any of the 25 participants included in each study group. There were no trials that evaluated different antibiotics or different antibiotic dosages.\nAuthors' conclusions\nScientific evidence suggests that, in general, antibiotics are beneficial for reducing failure of dental implants placed in ordinary conditions. Specifically 2 g or 3 g of amoxicillin given orally, as a single administration, one hour preoperatively significantly reduces failure of dental implants. No significant adverse events were reported. It might be sensible to suggest the use of a single dose of 2 g prophylactic amoxicillin prior to dental implant placement. It is still unknown whether postoperative antibiotics are beneficial, and which antibiotic is the most effective.\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": "Missing teeth can sometimes be replaced with dental implants to which a crown, bridge or denture can be attached. Bacteria introduced during the placement of implants can lead to infection, and sometimes implant failure. Infections around biomaterials (such as dental implants) are difficult to treat and almost all infected implants have to be removed, which is why it is so important to prevent infection if possible.\nIt has been suggested that taking antibiotics orally either before or after placement (or both) can minimise the chances of infection.\nGenerally the use of antibiotics in surgery in order to prevent infection is only recommended for people at risk, when surgery is extensive, or performed in infected sites, and when large foreign materials are implanted in the body. Recently, a short term course of antibiotics has been recommended when antibiotics have to be used, because sometimes antibiotics can cause side effects that range from diarrhoea to life-threatening allergic reactions. Another major concern associated with the widespread use of antibiotics is the increase in the appearance of antibiotic-resistant bacteria."
}
]
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query-laysum | 4975 | [
{
"role": "user",
"content": "Abstract: Background\nThe management of anticoagulation therapy around the time of catheter ablation (CA) procedure for adults with arrhythmia is critical and yet is variable in clinical practice. The ideal approach for safe and effective perioperative management should balance the risk of bleeding during uninterrupted anticoagulation while minimising the risk of thromboembolic events with interrupted therapy.\nObjectives\nTo compare the efficacy and harms of interrupted versus uninterrupted anticoagulation therapy for catheter ablation (CA) in adults with arrhythmias.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and SCI-Expanded on the Web of Science for randomised controlled trials on 5 January 2021. We also searched three registers on 29 May 2021 to identify ongoing or unpublished trials. We performed backward and forward searches on reference lists of included trials and other systematic reviews and contacted experts in the field. We applied no restrictions on language or publication status.\nSelection criteria\nWe included randomised controlled trials comparing uninterrupted anticoagulation with any modality of interruption with or without heparin bridging for CA in adults aged 18 years or older with arrhythmia.\nData collection and analysis\nTwo review authors conducted independent screening, data extraction, and assessment of risk of bias. A third review author resolved disagreements. We extracted data on study population, interruption strategy, ablation procedure, thromboembolic events (stroke or systemic embolism), major and minor bleeding, asymptomatic thromboembolic events, cardiovascular and all-cause mortality, quality of life (QoL), length of hospital stay, cost, and source of funding. We used GRADE to assess the certainty of the evidence.\nMain results\nWe identified 12 studies (4714 participants) that compared uninterrupted periprocedural anticoagulation with interrupted anticoagulation. Studies performed an interruption strategy by either a complete interruption (one study) or by a minimal interruption (11 studies), of which a single-dose skipped strategy was used (nine studies) or two-dose skipped strategy (two studies), with or without heparin bridging.\nStudies included participants with a mean age of 65 years or greater, with only two studies conducted in relatively younger individuals (mean age less than 60 years). Paroxysmal atrial fibrillation (AF) was the primary type of AF in all studies, and seven studies included other types of AF (persistent and long-standing persistent). Most participants had CHADS2 or CHADS2-VASc demonstrating a low–moderate risk of stroke, with almost all participants having normal or mildly reduced renal function. Ablation source using radiofrequency energy was the most common (seven studies).\nTen studies (2835 participants) were conducted in East Asian countries (Japan, China, and South Korea), while the remaining two studies were conducted in the USA. Eight studies were conducted in a single centre. Postablation follow-up was variable among studies at less than 30 days (three studies), 30 days (six studies), and more than 30 days postablation (three studies).\nOverall, the meta-analysis showed high uncertainty of the effect between the interrupted strategy compared to uninterrupted strategy on the primary outcomes of thromboembolic events (risk ratio (RR) 1.76, 95% confidence interval (CI) 0.33 to 9.46; I2 = 59%; 6 studies, 3468 participants; very low-certainty evidence). However, subgroup analysis showed that uninterrupted vitamin K antagonist (VKA) is associated with a lower risk of thromboembolic events without increasing the risk of bleeding. There is also uncertainty on the outcome of major bleeding events (RR 1.10, 95% CI 0.59 to 2.05; I2 = 6%; 10 studies, 4584 participants; low-certainty evidence). The uncertainty was also evident for the secondary outcomes of minor bleeding (RR 1.01, 95% CI 0.46 to 2.22; I2 = 87%; 9 studies, 3843 participants; very low-certainty evidence), all-cause mortality (RR 0.34, 95% CI 0.01 to 8.21; 442 participants; low-certainty evidence) and asymptomatic thromboembolic events (RR 1.45, 95% CI 0.85 to 2.47; I2 = 56%; 6 studies, 1268 participants; very low-certainty evidence). There was a lower risk of the composite endpoint of thromboembolic events (stroke, systemic embolism, major bleeding, and all-cause mortality) in the interrupted compared to uninterrupted arm (RR 0.23, 95% CI 0.07 to 0.81; 1 study, 442 participants; low-certainty evidence).\nIn general, the low event rates, different comparator anticoagulants, and use of different ablation procedures may be the cause of imprecision and heterogeneity observed.\nAuthors' conclusions\nThis meta-analysis showed that the evidence is uncertain to inform the decision to either interrupt or continue anticoagulation therapy around CA procedure in adults with arrhythmia on outcomes of thromboembolic events, major and minor bleeding, all-cause mortality, asymptomatic thromboembolic events, and a composite endpoint of thromboembolic events (stroke, systemic embolism, major bleeding, and all-cause mortality).\nMost studies in the review adopted a minimal interruption strategy which has the advantage of reducing the risk of bleeding while maintaining a lower level of anticoagulation to prevent periprocedural thromboembolism, hence low event rates on the primary outcomes of thromboembolism and bleeding. The one study that adopted a complete interruption of VKA showed that uninterrupted VKA reduces the risk of thromboembolism without increasing the risk of bleeding. Hence, future trials with larger samples, tailored to a more generalisable population and using homogeneous periprocedural anticoagulant therapy and ablation source are required to address the safety and efficacy of the optimal management of anticoagulant therapy prior to ablation.\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": "Due to the uncertainty of the evidence, after combining the results from the 12 clinical trials in this review, we are unsure about advising one strategy over another with the current evidence. The decision to continue, completely stop or withhold one or two doses of the blood thinner before the procedure should be individualised based on the patient's risks of stroke and bleeding until more well-designed clinical trials are available to inform a conclusive decision."
}
]
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query-laysum | 4976 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants require high protein intake to achieve adequate growth and development. Although breast milk feeding has many benefits for this population, the protein content is highly variable, and inadequate to support rapid infant growth. This is a 2020 update of a Cochrane Review first published in 1999.\nObjectives\nTo determine whether protein-supplemented human milk compared with unsupplemented human milk, fed to preterm infants, improves growth, body composition, cardio-metabolic, and neurodevelopmental outcomes, without significant adverse effects.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 8) in the Cochrane Library and MEDLINE via PubMed on 23 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nPublished and unpublished RCTs were eligible if they used random or quasi-random methods to allocate hospitalised preterm infants who were being fed human milk, to additional protein supplementation or no supplementation.\nData collection and analysis\nTwo review authors independently abstracted data, assessed risk of bias and the quality of evidence at the outcome level, using GRADE methodology. We performed meta-analyses, using risk ratio (RR) for dichotomous data, and mean difference (MD) for continuous data, with their respective 95% confidence intervals (CIs). We used a fixed-effect model and had planned to explore potential causes of heterogeneity via subgroup or sensitivity analyses.\nMain results\nWe included six RCTs, involving 204 preterm infants. The risk of bias for most methodological domains was unclear as there was insufficient detail reported. Low-quality evidence showed that protein supplementation of human milk may increase in-hospital rates of growth in weight (MD 3.82 g/kg/day, 95% CI 2.94 to 4.7; five RCTs, 101 infants; I² = 73%), length (MD 0.12 cm/wk, 95% CI 0.07 to 0.17; four RCTs, 68 infants; I² = 89%), and head circumference (MD 0.06 cm/wk, 95% CI 0.01 to 0.12; four RCTs, 68 infants; I² = 84%). Protein supplementation may lead to longer hospital stays (MD 18.5 days, 95% CI 4.39 to 32.61; one RCT, 20 infants; very low-quality evidence). Very low quality evidence means that the effect of protein supplementation on the risk of feeding intolerance (RR 2.70, 95% CI 0.13 to 58.24; one RCT, 17 infants), or necrotizing enterocolitis (RR 1.11, 95% CI 0.07 to 17.12; one RCT, 76 infants) remains uncertain. No data were available about the effects of protein supplementation on neurodevelopmental outcomes.\nAuthors' conclusions\nLow-quality evidence showed that protein supplementation of human milk, fed to preterm infants, increased short-term growth. However, the small sample sizes, low precision, and very low-quality evidence regarding duration of hospital stay, feeding intolerance, and necrotising enterocolitis precluded any conclusions about these outcomes. There were no data on outcomes after hospital discharge. Our findings may not be generalisable to low-resource settings, as none of the included studies were conducted in these settings.\nSince protein supplementation of human milk is now usually done as a component of multi-nutrient fortifiers, future studies should compare different amounts of protein in multi-component fortifiers, and be designed to determine the effects on duration of hospital stay and safety, as well as on long-term growth, body composition, cardio-metabolic, and neurodevelopmental outcomes.\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": "Adding extra protein to human milk for preterm infants may increase short-term growth. However, its effect on length of hospital stay, feeding intolerance, and necrotizing enterocolitis is uncertain, due to data limitations and very low-quality evidence. There were no data about effects on later health and development, or effects in low resource settings.\nSince protein supplementation of human milk is now usually done as a component of multi-nutrient fortifiers, future studies should compare different amounts of protein in multi-component fortifiers, and be designed to determine the effects on length of hospital stay, safety, long-term growth, body fat, obesity, high blood sugar, and brain development."
}
]
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query-laysum | 4977 | [
{
"role": "user",
"content": "Abstract: Background\nCollaborative writing applications (CWAs), such as wikis and Google Documents, hold the potential to improve the use of evidence in both public health and healthcare. Although a growing body of literature indicates that CWAs could have positive effects on healthcare, such as improved collaboration, behavioural change, learning, knowledge management, and adaptation of knowledge to local context, this has never been assessed systematically. Moreover, several questions regarding safety, reliability, and legal aspects exist.\nObjectives\nThe objectives of this review were to (1) assess the effects of the use of CWAs on process (including the behaviour of healthcare professionals) and patient outcomes, (2) critically appraise and summarise current evidence on the use of resources, costs, and cost-effectiveness associated with CWAs to improve professional practices and patient outcomes, and (3) explore the effects of different CWA features (e.g. open versus closed) and different implementation factors (e.g. the presence of a moderator) on process and patient outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and 11 other electronic databases. We searched the grey literature, two trial registries, CWA websites, individual journals, and conference proceedings. We also contacted authors and experts in the field. We did not apply date or language limits. We searched for published literature to August 2016, and grey literature to September 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-and-after (CBA) studies, interrupted time series (ITS) studies, and repeated measures studies (RMS), in which CWAs were used as an intervention to improve the process of care, patient outcomes, or healthcare costs.\nData collection and analysis\nTeams of two review authors independently assessed the eligibility of studies. Disagreements were resolved by discussion, and when consensus was not reached, a third review author was consulted.\nMain results\nWe screened 11,993 studies identified from the electronic database searches and 346 studies from grey literature sources. We analysed the full text of 99 studies. None of the studies met the eligibility criteria; two potentially relevant studies are ongoing.\nAuthors' conclusions\nWhile there is a high number of published studies about CWAs, indicating that this is an active field of research, additional studies using rigorous experimental designs are needed to assess their impact and cost-effectiveness on process and patient outcomes.\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 did not identify any studies that measured the effect of CWAs on how healthcare professionals care for their patients."
}
]
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query-laysum | 4978 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculous pericarditis can impair the heart's function and cause death; long term, it can cause the membrane to fibrose and constrict causing heart failure. In addition to antituberculous chemotherapy, treatments include corticosteroids, drainage, and surgery.\nObjectives\nTo assess the effects of treatments for tuberculous pericarditis.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register (27 March 2017); the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library (2017, Issue 2); MEDLINE (1966 to 27 March 2017); Embase (1974 to 27 March 2017); and LILACS (1982 to 27 March 2017). In addition we searched the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal using 'tuberculosis' and 'pericard*' as search terms on 27 March 2017. We searched ClinicalTrials.gov and contacted researchers in the field of tuberculous pericarditis. This is a new version of the original 2002 review.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs.\nData collection and analysis\nTwo review authors independently screened search outputs, evaluated study eligibility, assessed risk of bias, and extracted data; and we resolved any discrepancies by discussion and consensus. One trial assessed the effects of both corticosteroid and Mycobacterium indicus pranii treatment in a two-by-two factorial design; we excluded data from the group that received both interventions. We conducted fixed-effect meta-analysis and assessed the certainty of the evidence using the GRADE approach.\nMain results\nSeven trials met the inclusion criteria; all were from sub-Saharan Africa and included 1959 participants, with 1051/1959 (54%) HIV-positive. All trials evaluated corticosteroids and one each evaluated colchicine, M. indicus pranii immunotherapy, and open surgical drainage. Four trials (1841 participants) were at low risk of bias, and three trials (118 participants) were at high risk of bias.\nIn people who are not infected with HIV, corticosteroids may reduce deaths from all causes (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.59 to 1.09; 660 participants, 4 trials, low certainty evidence) and the need for repeat pericardiocentesis (RR 0.85, 95% CI 0.70 to 1.04; 492 participants, 2 trials, low certainty evidence). Corticosteroids probably reduce deaths from pericarditis (RR 0.39, 95% CI 0.19 to 0.80; 660 participants, 4 trials, moderate certainty evidence). However, we do not know whether or not corticosteroids have an effect on constriction or cancer among HIV-negative people (very low certainty evidence).\nIn people living with HIV, only 19.9% (203/1959) were on antiretroviral drugs. Corticosteroids may reduce constriction (RR 0.55, 0.26 to 1.16; 575 participants, 3 trials, low certainty evidence). It is uncertain whether corticosteroids have an effect on all-cause death or cancer (very low certainty evidence); and may have little or no effect on repeat pericardiocentesis (RR 1.02, 0.89 to 1.18; 517 participants, 2 trials, low certainty evidence).\nFor colchicine among people living with HIV, we found one small trial (33 participants) which had insufficient data to make any conclusions about any effects on death or constrictive pericarditis.\nIrrespective of HIV status, due to very low certainty evidence from one trial, it is uncertain whether adding M. indicus pranii immunotherapy to antituberculous drugs has an effect on any outcome.\nOpen surgical drainage for effusion may reduce repeat pericardiocentesis In HIV-negative people (RR 0.23, 95% CI 0.07 to 0.76; 122 participants, 1 trial, low certainty evidence) but may make little or no difference to other outcomes. We did not find an eligible trial that assessed the effects of open surgical drainage in people living with HIV.\nThe review authors found no eligible trials that examined the length of antituberculous treatment needed nor the effects of other adjunctive treatments for tuberculous pericarditis.\nAuthors' conclusions\nFor HIV-negative patients, corticosteroids may reduce death. For HIV-positive patients not on antiretroviral drugs, corticosteroids may reduce constriction. For HIV-positive patients with good antiretroviral drug viral suppression, clinicians may consider the results from HIV-negative patients more relevant.\nFurther research may help evaluate percutaneous drainage of the pericardium under local anaesthesia, the timing of pericardiectomy in tuberculous constrictive pericarditis, and new antibiotic regimens.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to assess the effects of treatments for people with tuberculous pericarditis."
}
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query-laysum | 4979 | [
{
"role": "user",
"content": "Abstract: Background\nLaparoscopy is a common procedure in many surgical specialties. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life-threatening complications include injury to viscera (e.g. bowel, bladder) or to vasculature (e.g. major abdominal and anterior abdominal wall vessels). No clear consensus has been reached as to the optimal method of laparoscopic entry into the peritoneal cavity.\nObjectives\nTo evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, and trials registers in January 2018. We also checked the references of articles retrieved.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared one laparoscopic entry technique versus another. Primary outcomes were major complications including mortality, vascular injury of major vessels and abdominal wall vessels, visceral injury of bladder or bowel, gas embolism, solid organ injury, and failed entry (inability to access the peritoneal cavity). Secondary outcomes were extraperitoneal insufflation, trocar site bleeding, trocar site infection, incisional hernia, omentum injury, and uterine bleeding.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods.\nMain results\nThe review included 57 RCTs including four multi-arm trials, with a total of 9865 participants, and evaluated 25 different laparoscopic entry techniques. Most studies selected low-risk patients, and many studies excluded patients with high body mass index (BMI) and previous abdominal surgery. Researchers did not find evidence of differences in major vascular or visceral complications, as would be anticipated given that event rates were very low and sample sizes were far too small to identify plausible differences in rare but serious adverse events.\nOpen-entry versus closed-entry\nTen RCTs investigating Veress needle entry reported vascular injury as an outcome. There was a total of 1086 participants and 10 events of vascular injury were reported. Four RCTs looking at open entry technique reported vascular injury as an outcome. There was a total of 376 participants and 0 events of vascular injury were reported. This was not a direct comparison. In the direct comparison of Veress needle and Open-entry technique, there was insufficient evidence to determine whether there was a difference in rates of vascular injury (Peto OR 0.14, 95% CI 0.00 to 6.82; 4 RCTs; n = 915; I² = N/A, very low-quality evidence). Evidence was insufficient to show whether there were differences between groups for visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08; 4 RCTs; n = 915: I² = 0%; very low-quality evidence), or failed entry (Peto OR 0.45, 95% CI 0.14 to 1.42; 3 RCTs; n = 865; I² = 63%; very low-quality evidence). Two studies reported mortality with no events in either group. No studies reported gas embolism or solid organ injury.\nDirect trocar versus Veress needle entry\nTrial results show a reduction in failed entry into the abdomen with the use of a direct trocar in comparison with Veress needle entry (OR 0.24, 95% CI 0.17 to 0.34; 8 RCTs; N = 3185; I² = 45%; moderate-quality evidence). Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.59, 95% CI 0.18 to 1.96; 6 RCTs; n = 1603; I² = 75%; very low-quality evidence), visceral injury (Peto OR 2.02, 95% CI 0.21 to 19.42; 5 RCTs; n = 1519; I² = 25%; very low-quality evidence), or solid organ injury (Peto OR 0.58, 95% Cl 0.06 to 5.65; 3 RCTs; n = 1079; I² = 61%; very low-quality evidence). Four studies reported mortality with no events in either group. Two studies reported gas embolism, with no events in either group.\nDirect vision entry versus Veress needle entry\nEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.39, 95% CI 0.05 to 2.85; 1 RCT; n = 186; very low-quality evidence) or visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34; 2 RCTs; n = 380; I² = N/A; very low-quality evidence). Trials did not report our other primary outcomes.\nDirect vision entry versus open entry\nEvidence was insufficient to show whether there were differences between groups in rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50; 2 RCTs; n = 392; I² = N/A; very low-quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67; 1 RCT; n = 60; very low-quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09; 1 RCT; n = 60; very low-quality evidence). Two studies reported vascular injury with no events in either arm. Trials did not report our other primary outcomes.\nRadially expanding (STEP) trocars versus non-expanding trocars\nEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21; 2 RCTs; n = 331; I² = 0%; very low-quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37; 2 RCTs; n = 331; very low-quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91; 1 RCT; n = 244; very low-quality evidence). Trials did not report our other primary outcomes.\nOther studies compared a wide variety of other laparoscopic entry techniques, but all evidence was of very low quality and evidence was insufficient to support the use of one technique over another.\nAuthors' conclusions\nOverall, evidence was insufficient to support the use of one laparoscopic entry technique over another. Researchers noted an advantage of direct trocar entry over Veress needle entry for failed entry. Most evidence was of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods.\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": "Most evidence is of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods."
}
]
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query-laysum | 4980 | [
{
"role": "user",
"content": "Abstract: Background\nTemporomandibular disorders (TMDs) are a group of musculoskeletal disorders affecting the jaw. They are frequently associated with pain that can be difficult to manage and may become persistent (chronic). Psychological therapies aim to support people with TMDs to manage their pain, leading to reduced pain, disability and distress.\nObjectives\nTo assess the effects of psychological therapies in people (aged 12 years and over) with painful TMD lasting 3 months or longer.\nSearch methods\nCochrane Oral Health's Information Specialist searched six bibliographic databases up to 21 October 2021 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of any psychological therapy (e.g. cognitive behaviour therapy (CBT), behaviour therapy (BT), acceptance and commitment therapy (ACT), mindfulness) for the management of painful TMD. We compared these against control or alternative treatment (e.g. oral appliance, medication, physiotherapy).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We reported outcome data immediately after treatment and at the longest available follow-up.\nWe used the Cochrane RoB 1 tool to assess the risk of bias in included studies. Two review authors independently assessed each included study for any risk of bias in sequence generation, allocation concealment, blinding of outcome assessors, incomplete outcome data, selective reporting of outcomes, and other issues. We judged the certainty of the evidence for each key comparison and outcome as high, moderate, low or very low according to GRADE criteria.\nMain results\nWe identified 22 RCTs (2001 participants), carried out between 1967 and 2021. We were able to include 12 of these studies in meta-analyses. The risk of bias was high across studies, and we judged the certainty of the evidence to be low to very low overall; further research may change the findings. Our key outcomes of interest were: pain intensity, disability caused by pain, adverse events and psychological distress. Treatments varied in length, with the shortest being 4 weeks. The follow-up time ranged from 3 months to 12 months. Most studies evaluated CBT.\nAt treatment completion, there was no evidence of a benefit of CBT on pain intensity when measured against alternative treatment (standardised mean difference (SMD) 0.03, confidence interval (CI) -0.21 to 0.28; P = 0.79; 5 studies, 509 participants) or control (SMD -0.09, CI -0.30 to 0.12; P = 0.41; 6 studies, 577 participants). At follow-up, there was evidence of a small benefit of CBT for reducing pain intensity compared to alternative treatment (SMD -0.29, 95% CI -0.50 to -0.08; 5 studies, 475 participants) and control (SMD -0.30, CI -0.51 to -0.09; 6 studies, 639 participants).\nAt treatment completion, there was no evidence of a difference in disability outcomes (interference in activities caused by pain) between CBT and alternative treatment (SMD 0.15, CI -0.40 to 0.10; P = 0.25; 3 studies, 245 participants), or between CBT and control/usual care (SMD 0.02, CI -0.21 to 0.24; P = 0.88; 3 studies, 315 participants). Nor was there evidence of a difference at follow-up (CBT versus alternative treatment: SMD -0.15, CI -0.42 to 0.12; 3 studies, 245 participants; CBT versus control: SMD 0.01 CI - 0.61 to 0.64; 2 studies, 240 participants).\nThere were very few data on adverse events. From the data available, adverse effects associated with psychological treatment tended to be minor and to occur less often than in alternative treatment groups. There were, however, insufficient data available to draw firm conclusions.\nCBT showed a small benefit in terms of reducing psychological distress at treatment completion compared to alternative treatment (SMD -0.32, 95% CI -0.50 to -0.15; 6 studies, 553 participants), which was maintained at follow-up (SMD -0.32, 95% CI -0.51 to -0.13; 6 studies, 516 participants). For CBT versus control, only one study reported results for distress and did not find evidence of a difference between groups at treatment completion (mean difference (MD) 2.36, 95% CI -1.17 to 5.89; 101 participants) or follow-up (MD -1.02, 95% CI -4.02 to 1.98; 101 participants).\nWe assessed the certainty of the evidence to be low or very low for all comparisons and outcomes.\nThe data were insufficient to draw any reliable conclusions about psychological therapies other than CBT.\nAuthors' conclusions\nWe found mixed evidence for the effects of psychological therapies on painful temporomandibular disorders (TMDs). There is low-certainty evidence that CBT may reduce pain intensity more than alternative treatments or control when measured at longest follow-up, but not at treatment completion. There is low-certainty evidence that CBT may be better than alternative treatments, but not control, for reducing psychological distress at treatment completion and follow-up. There is low-certainty evidence that CBT may not be better than other treatments or control for pain disability outcomes.\nThere is insufficient evidence to draw conclusions about alternative psychological therapeutic approaches, and there are insufficient data to be clear about adverse effects that may be associated with psychological therapies for painful TMD.\nOverall, we found insufficient evidence on which to base a reliable judgement about the efficacy of psychological therapies for painful TMD. Further research is needed to determine whether or not psychological therapies are effective, the most effective type of therapy and delivery method, and how it can best be targeted. In particular, high-quality RCTs conducted in primary care and community settings are required, which evaluate a range of psychological approaches against alternative treatments or usual care, involve both adults and adolescents, and collect measures of pain intensity, pain disability and psychological distress until at least 12 months post-treatment.\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 little confidence in the evidence because many of the studies had design limitations. There was also variation in the length of treatment and in how it was delivered. This means that we need to be cautious in interpreting the results that we found and they may not be reliable."
}
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query-laysum | 4981 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is an autoimmune, T-cell-dependent, inflammatory, demyelinating disease of the central nervous system, with an unpredictable course. Current MS therapies focus on treating and preventing exacerbations, and avoiding the progression of disability. At present, there is no treatment that is capable of safely and effectively reaching these objectives. Clinical trials suggest that alemtuzumab, a humanized monoclonal antibody, could be a promising option for MS.\nObjectives\nTo evaluate the benefits and harms of alemtuzumab alone or associated with other treatments in people with any form of MS.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 21 June 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with any subtype of MS comparing alemtuzumab alone or associated with other medications versus placebo; another active drug; or alemtuzumab in another dose, regimen, or duration.\nData collection and analysis\nWe used standard Cochrane methods. Our co-primary outcomes were 1. relapse-free survival, 2. sustained disease progression, and 3. number of participants experiencing at least one adverse event. Our secondary outcomes were 4. participants free of clinical disability, 5. quality of life, 6. change in disability, 7. fatigue, 8. new or enlarging lesions on resonance imaging, and 9. dropouts. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included three RCTs (1713 participants) comparing intravenous alemtuzumab versus subcutaneous interferon beta-1a for relapsing–remitting MS. Participants were treatment-naive (two studies) or had experienced at least one relapse after interferon or glatiramer (one study). Alemtuzumab was given at doses of 12 mg/day or 24 mg/day for five days at months 0 and 12, or 24 mg/day for three days at months 12 and 24. Participants in the interferon beta-1a group received 44 μg three times weekly.\nAlemtuzumab 12 mg: 1. may improve relapse-free survival at 36 months (hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.18 to 0.53; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.25, 95% CI 0.11 to 0.56; 1 study, 223 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (risk ratio [RR] 1.00, 95% CI 0.98 to 1.02; 1 study, 224 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (mean difference [MD] −0.70, 95% CI −1.04 to −0.36; 1 study, 223 participants; low-certainty evidence). The evidence is very uncertain regarding the risk of dropouts at 36 months (RR 0.81, 95% CI 0.57 to 1.14; 1 study, 224 participants; very low-certainty evidence).\nAlemtuzumab 24 mg: 1. may improve relapse-free survival at 36 months (HR 0.21, 95% CI 0.11 to 0.40; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.33, 95% CI 0.16 to 0.69; 1 study, 221 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (RR 0.99, 95% CI 0.97 to 1.02; 1 study, 215 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (MD −0.83, 95% CI −1.16 to −0.50; 1 study, 221 participants; low-certainty evidence); 5. may reduce the risk of dropouts at 36 months (RR 0.08, 95% CI 0.01 to 0.57; 1 study, 215 participants; low-certainty evidence).\nFor quality of life, fatigue, and participants free of clinical disease activity, the studies either did not consider these outcomes or they used different measuring tools to those planned in this review.\nAuthors' conclusions\nCompared with interferon beta-1a, alemtuzumab may improve relapse-free survival and sustained disease progression-free survival, and make little to no difference on the proportion of participants with at least one adverse event for people with relapsing–remitting MS at 36 months. The certainty of the evidence for these results was very low to low.\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": "Our confidence in the effects of alemtuzumab, compared to interferon beta-1a, for the main outcomes ranges from low to very low. This means that there is a high probability that future studies could change our conclusions."
}
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query-laysum | 4982 | [
{
"role": "user",
"content": "Abstract: Background\nIron-deficiency anaemia is highly prevalent among non-pregnant women of reproductive age (menstruating women) worldwide, although the prevalence is highest in lower-income settings. Iron-deficiency anaemia has been associated with a range of adverse health outcomes, which restitution of iron stores using iron supplementation has been considered likely to resolve. Although there have been many trials reporting effects of iron in non-pregnant women, these trials have never been synthesised in a systematic review.\nObjectives\nTo establish the evidence for effects of daily supplementation with iron on anaemia and iron status, as well as on physical, psychological and neurocognitive health, in menstruating women.\nSearch methods\nIn November 2015 we searched CENTRAL, Ovid MEDLINE, EMBASE, and nine other databases, as well as four digital thesis repositories. In addition, we searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and reference lists of relevant reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing daily oral iron supplementation with or without a cointervention (folic acid or vitamin C), for at least five days per week at any dose, to control or placebo using either individual- or cluster-randomisation. Inclusion criteria were menstruating women (or women aged 12 to 50 years) reporting on predefined primary (anaemia, haemoglobin concentration, iron deficiency, iron-deficiency anaemia, all-cause mortality, adverse effects, and cognitive function) or secondary (iron status measured by iron indices, physical exercise performance, psychological health, adherence, anthropometric measures, serum/plasma zinc levels, vitamin A status, and red cell folate) outcomes.\nData collection and analysis\nWe used the standard methodological procedures of Cochrane.\nMain results\nThe search strategy identified 31,767 records; after screening, 90 full-text reports were assessed for eligibility. We included 67 trials (from 76 reports), recruiting 8506 women; the number of women included in analyses varied greatly between outcomes, with endpoint haemoglobin concentration being the outcome with the largest number of participants analysed (6861 women). Only 10 studies were considered at low overall risk of bias, with most studies presenting insufficient details about trial quality.\nWomen receiving iron were significantly less likely to be anaemic at the end of intervention compared to women receiving control (risk ratio (RR) 0.39 (95% confidence interval (CI) 0.25 to 0.60, 10 studies, 3273 women, moderate quality evidence). Women receiving iron had a higher haemoglobin concentration at the end of intervention compared to women receiving control (mean difference (MD) 5.30, 95% CI 4.14 to 6.45, 51 studies, 6861 women, high quality evidence). Women receiving iron had a reduced risk of iron deficiency compared to women receiving control (RR 0.62, 95% CI 0.50 to 0.76, 7 studies, 1088 women, moderate quality evidence). Only one study (55 women) specifically reported iron-deficiency anaemia and no studies reported mortality. Seven trials recruiting 901 women reported on 'any side effect' and did not identify an overall increased prevalence of side effects from iron supplements (RR 2.14, 95% CI 0.94 to 4.86, low quality evidence). Five studies recruiting 521 women identified an increased prevalence of gastrointestinal side effects in women taking iron (RR 1.99, 95% CI 1.26 to 3.12, low quality evidence). Six studies recruiting 604 women identified an increased prevalence of loose stools/diarrhoea (RR 2.13, 95% CI 1.10, 4.11, high quality evidence); eight studies recruiting 1036 women identified an increased prevalence of hard stools/constipation (RR 2.07, 95% CI 1.35 to 3.17, high quality evidence). Seven studies recruiting 1190 women identified evidence of an increased prevalence of abdominal pain among women randomised to iron (RR 1.55, 95% CI 0.99 to 2.41, low quality evidence). Eight studies recruiting 1214 women did not find any evidence of an increased prevalence of nausea among women randomised to iron (RR 1.19, 95% CI 0.78 to 1.82). Evidence that iron supplementation improves cognitive performance in women is uncertain, as studies could not be meta-analysed and individual studies reported conflicting results. Iron supplementation improved maximal and submaximal exercise performance, and appears to reduce symptomatic fatigue. Although adherence could not be formally meta-analysed due to differences in reporting, there was no evident difference in adherence between women randomised to iron and control.\nAuthors' conclusions\nDaily iron supplementation effectively reduces the prevalence of anaemia and iron deficiency, raises haemoglobin and iron stores, improves exercise performance and reduces symptomatic fatigue. These benefits come at the expense of increased gastrointestinal symptomatic side effects.\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": "Iron deficiency (a shortage of iron stored in the body) and anaemia (low levels of haemoglobin - healthy red blood cells - in the blood) are common problems globally, especially in women. Low levels of iron can eventually cause anaemia (iron-deficiency anaemia). Among non-pregnant women, around one third are anaemic worldwide. The problem is seen most commonly in low-income countries, but iron deficiency and anaemia are more common in women in all contexts. Iron-deficiency anaemia is considered to impair health and well-being in women, and iron supplements - tablets, capsules, syrup or drops containing iron - are a commonly used intervention to prevent and treat this condition. We sought to review the evidence of iron, taken orally for at least five days per week, for improving health outcomes in non-pregnant women of reproductive age (menstruating women)."
}
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query-laysum | 4983 | [
{
"role": "user",
"content": "Abstract: Background\nA large proportion of children younger than five years of age in high-income countries experience significant non-parental care. Centre-based day care services may influence the development of children and the economic situation of parents.\nObjectives\nTo assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development and well-being of children and families in high-income countries (as defined by the World Bank 2011).\nSearch methods\nIn April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, the Education Resources Information Center (ERIC) and eight other databases. We also searched two trials registers and the reference lists of relevant studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials of centre-based day care for children younger than five years of age. We excluded studies that involved co-interventions not directed toward children (e.g. parent programmes, home visits, teacher training). We included the following outcomes: child cognitive development (primary outcome), child psychosocial development, maternal and family outcomes and child long-term outcomes.\nData collection and analysis\nTwo review authors independently assessed the risk of bias and extracted data from the single included study. We contacted investigators to obtain missing information.\nMain results\nWe included in the review one trial, involving 120 families and 143 children. Risk of bias was high because of contamination between groups, as 63% of control group participants accessed day care services separate from those offered within the intervention. No evidence suggested that centre-based day care, rather than no treatment (care at home), improved or worsened children's cognitive ability (Griffiths Mental Development Scale, standardised mean difference (SMD) 0.34, 95% confidence interval (CI) -0.01 to 0.69, 127 participants, 1 study, very low-quality evidence) or psychosocial development (parental report of abnormal development, risk ratio (RR) 1.21, 95% CI 0.25 to 5.78, 137 participants, 1 study, very low-quality evidence). No other measures of child intellectual or psychosocial development were reported in the included study. Moreover, no evidence indicated that centre-based day care, rather than no treatment (care at home), improved or worsened employment of parents, as measured by the number of mothers in full-time or part-time employment (RR 1.12, 95% CI 0.85 to 1.48, 114 participants, 1 study, very low-quality evidence) and maternal hours per week in paid employment (SMD 0.20, 95% -0.15 to 0.55, 127 participants, 1 study, very low-quality evidence) or household income above £200 per week (RR 0.86, 95% CI 0.57 to 1.29, 113 participants, 1 study, very low-quality evidence). This study did not report on long-term outcomes for children (high-school completion or income).\nAuthors' conclusions\nThis review includes one trial that provides inconclusive evidence as regards the effects of centre-based day care for children younger than five years of age and their families in high-income countries. Robust guidance for parents, policymakers and other stakeholders on the effects of day care cannot currently be offered on the basis of evidence from randomised controlled trials. Some trials included co-interventions that are unlikely to be found in normal day care centres. Effectiveness studies of centre-based day care without these co-interventions are few, and the need for such studies is significant. Comparisons might include home visits or alternative day care arrangements that provide special attention to children from low-income families while exploring possible mechanisms of effect.\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": "A large proportion of children younger than five years of age in high-income countries experience significant non-parental care. Centre-based day care services may influence the development of children and the economic situation of parents."
}
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query-laysum | 4984 | [
{
"role": "user",
"content": "Abstract: Background\nFatigue is a common and disabling symptom in people with a primary brain tumour (PBT). The effectiveness of interventions for treating clinically significant levels of fatigue in this population is unclear. This is an updated version of the original Cochrane Review published in Issue 4, 2016.\nObjectives\nTo assess the effectiveness and safety of pharmacological and non-pharmacological interventions for adults with PBT and clinically significant (or high levels) of fatigue.\nSearch methods\nFor this updated review, we searched CENTRAL, MEDLINE and Embase, and checked the reference lists of included studies in April 2022. We also searched relevant conference proceedings, and ClinicalTrials.gov for ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated any pharmacological or non-pharmacological intervention in adults with PBT and fatigue, where fatigue was the primary outcome measure. We restricted inclusion specifically to studies that enrolled only participants with clinically significant levels of fatigue to improve the clinical utility of the findings.\nData collection and analysis\nTwo review authors (JD, DC) independently evaluated search results for the updated search. Two review authors (JD, SYK) extracted data from selected studies, and carried out a risk of bias assessment. We extracted data on fatigue, mood, cognition, quality of life and adverse events outcomes.\nMain results\nThe original review identified one study and this update identified a further two for inclusion. One study investigated the use of modafinil, one study the use of armodafinil and one study the use of dexamfetamine. We identified three ongoing studies.\nIn the original review, the single eligible trial compared modafinil to placebo for 37 participants with a high- or low-grade PBT. One new study compared two doses of armodafinil (150 mg and 250 mg) to placebo for 297 people with a high-grade glioma. The second new study compared dexamfetamine sulfate to placebo for 46 participants with a low- or high-grade PBT. The evidence was uncertain for both modafinil and dexamfetamine regarding fatigue outcome measures, compared to controls, at study endpoint. Two trials did not reach the planned recruitment target and therefore may not, in practice, have been adequately powered to detect a difference. These trials were at a low risk of bias across most areas. There was an unclear risk of bias related to the use of mean imputation for one study because the investigators did not analyse the impact of imputation on the results and information regarding baseline characteristics and randomisation were not clear. The certainty of the evidence measured using GRADE was very low across all three studies.\nThere was one identified study awaiting classification once data are available, which investigated the feasibility of 'health coaching' for people with a PBT experiencing fatigue. There were three ongoing studies that may be eligible for an update of this review, all investigating a non-pharmacological intervention for fatigue in people with PBT.\nAuthors' conclusions\nThere is currently insufficient evidence to draw reliable and generalisable conclusions regarding potential effectiveness or harm of any pharmacological or non-pharmacological treatments for fatigue in people with PBT. More research is needed on how best to treat people with brain tumours with high fatigue.\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": "In April 2022, we searched four medical databases. We found three clinical trials that were eligible for inclusion. The three trials investigated the use of three medicines (modafinil, armodafinil and dexamfetamine sulfate) in adults with a primary brain tumour and high levels of fatigue. These medicines promote wakefulness."
}
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query-laysum | 4985 | [
{
"role": "user",
"content": "Abstract: Background\nFractures of the distal femur (the far end of the thigh bone just above the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains unknown.\nObjectives\nTo evaluate the benefits and harms of interventions for treating fractures of the distal femur in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was October 2021.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials in adults comparing interventions for treating fractures of the distal femur. Interventions included surgical implants (retrograde intramedullary nail (RIMN), fixed-angle devices, non-locking plate fixation, locking plate, internal fixation, distal femoral replacement, mono-axial plates, poly-axial plates and condylar buttress plates) and non-surgical management.\nData collection and analysis\nWe used standard Cochrane methods. Our critical outcomes were validated patient-reported outcome measures (PROMs), direct adverse events, participant-reported quality of life (QoL) and pain scores. Our other important outcomes were adverse events indirectly related to intervention, symptomatic non-union, malunion and resource use. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included 14 studies with 753 participants: 13 studies compared different surgical interventions, and one study compared surgical with non-surgical management. Here, we report the effects for RIMN compared with locking plates. Three studies (221 participants) reported this comparison; it included the largest study population and these are the two most commonly used devices in contemporary orthopaedic trauma practice.\nStudies used three different tools to assess PROMs. We found very-low certainty evidence for lower Disability Rating Index scores after RIMN at short-term follow-up favouring RIMN (mean difference (MD) −21.90, 95% confidence interval (CI) −38.16 to −5.64; 1 study, 12 participants) and low-certainty evidence of little or no difference at long-term follow-up (standardised mean difference (SMD) −0.22, 95% CI −0.50 to 0.06; 2 studies, 198 participants). Re-expressing the SMD of the long-term follow-up data to Knee Society Score (KSS) used by one study found no clinical benefit of RIMN, based on a minimal clinically important difference of 9 points (MD 2.47, 95% CI −6.18 to 0.74). The effect on QoL was very uncertain at four months (MD 0.01, 95% CI −0.42 to 0.44; 1 study, 14 participants) and one year (MD 0.10, 95% CI −0.01 to 0.21; 1 study, 156 participants); this evidence was very low certainty.\nFor direct adverse events, studies reported reoperation, loss of fixation, superficial and deep infection, haematoma formation and implant loosening. Effects for all events were imprecise with the possibility of benefit or harm for both treatments. We considered reoperation the most clinically relevant. There was very low-certainty evidence of little or no difference in reoperation between the two implants (risk ratio (RR) 1.48, 95% CI 0.55 to 4.00; 1 study, 104 participants).\nNo studies reported pain.\nFor other important outcomes, we noted that people treated with RIMN may be more likely to have varus/valgus deformity (RR 2.18, 95% CI 1.09 to 4.37; 1 study, 33 participants; low-certainty evidence). However, we found no evidence of any important differences between treatments in terms of bony union, indirect adverse events, or resource use.\nOther comparisons of surgical interventions included in the review were: RIMN versus single fixed-angle device (3 studies, 175 participants); RIMN versus non-locking plate fixation (1 study, 18 participants); locking plate versus single fixed-angle device (2 studies, 130 participants); internal fixation versus distal femoral replacement (1 study, 23 participants); mono-axial plates versus poly-axial plates (2 studies, 67 participants); mono-axial plate versus condylar buttress plate (1 study, 78 participants). The certainty of the evidence for outcomes in these comparisons was low to very low, and most effect estimates were imprecise.\nAuthors' conclusions\nThis review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform clinical practice. Priority should be given to randomised controlled trials comparing contemporary treatments for people with fractures of the distal femur. At a minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years, with an agreed core outcome set. All trials should be reported in full using the CONSORT guidelines.\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": ""
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query-laysum | 4986 | [
{
"role": "user",
"content": "Abstract: Background\nStudies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review.\nObjectives\nTo determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of last search: 01 April 2020.\nWe also searched online study registries and contacted authors. Date of last search: 12 February 2020.\nSelection criteria\nRandomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo.\nData collection and analysis\nTwo authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The quality of the evidence was assessed using GRADE.\nMain results\nThe searches identified 23 studies; five studies with 106 participants (children and adults) were included; duration of studies and interventions differed. Two studies compared omega-3 fatty acids to olive oil for six weeks; one study compared omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends) for three months; one study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months; and one study compared omega-3 fatty acids to a placebo for 12 months. Three studies had a low risk of bias for randomisation, but the risk was unclear in the remaining two studies; all studies had an unclear risk of bias for allocation concealment. Three of the studies adequately blinded participants; the risk of bias for selective reporting was high in one study and unclear for four studies.\nTwo studies reported the number of respiratory exacerbations. At three months, one study (43 participants) reported no change in antibiotic usage. At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.\nWith regards to adverse events, one six-week study (12 participants) reported no difference in diarrhoea between omega-3 or placebo capsules; the very low-quality evidence means we are unsure if supplementation has any effect on this outcome. Additionally, one study reported an increase in steatorrhoea requiring participants to increase their daily dose of pancreatic enzymes, but three studies had already increased pancreatic enzyme dose at study begin so as to reduce the incidence of steatorrhoea. One study (43 participants) reported stomach pains at three months (treatment or control group not specified). One six-week study (19 participants) reported three asthma exacerbations leading to exclusion of participants since corticosteroid treatment could affect affect essential fatty acid metabolism.\nFour studies reported lung function. One six-week study (19 participants) reported an increase in forced expiratory volume in one second (FEV1) (L) and forced vital capacity (FVC) (L), but the very low-quality evidence means we are unsure if supplementation has any effect on lung function. The remaining studies did not report any difference in lung function at three months (unit of measurement not specified) or at six months and one year (FEV1 % predicted and FVC % predicted).\nNo deaths were reported in any of the five studies. Four studies reported clinical variables. One study reported an increase in Schwachman score and weight alongside a reduction in sputum volume with supplementation compared to placebo at three months (data not analysable). However, three studies reported no differences in either weight at six weeks, in body mass index (BMI) standard deviation (SD) score at six months (very low-quality evidence) or BMI Z score at 12 months.\nThree studies reported biochemical markers of fatty acid status. One study showed an increase from baseline in both EPA and DHA content of serum phospholipids in the omega-3 group compared to placebo at three months and also a significant decrease in n-6/n-3 ratio in the supplement group compared to placebo; since the quality of the evidence is very low we are not certain that these changes are due to supplementation. One six-month cross-over study showed a higher EPA content of the neutrophil membrane in the supplement group compared to the placebo group, but, no difference in DHA membrane concentration. Furthermore, the leukotriene B4 to leukotriene B5 ratio was lower at six months in the omega-3 group compared to placebo. A one-year study reported a greater increase in the essential fatty acid profile and a decrease in AA levels in the treatment arm compared to placebo.\nAuthors' conclusions\nThis review found that regular omega-3 supplements may provide some limited benefits for people with cystic fibrosis with relatively few adverse effects: however, the quality of the evidence across all outcomes was very low. The current evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes when providing omega-3 supplementation or olive oil placebo capsules. More research is required to determine the exact dose of pancreatic enzyme 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": "Due to the very low-quality evidence, we are uncertain whether the following effects are due to supplementation or not. One 12-month study reported a reduction in pulmonary exacerbations and antibiotic use when taking omega-3 supplementation compared to placebo and one three-month study reported no change in antibiotic use during the study period. Few side effects were reported in any of the studies. One six-week study reported that lung function and clinical status improved when taking omega-3 supplements. Sputum levels were also noted to be reduced in this six-week study. Three studies reported no difference in lung function when taking omega-3 supplementation compared to placebo. Two longer studies found that people taking omega-3 supplements showed definite increases in levels of essential fatty acids in their white blood cell membranes and also in levels of phospholipids (molecules that provide structure and protection to cells) measured in blood samples.\nWe are uncertain whether regular omega-3 supplements benefit people with cystic fibrosis and whether they cause side effects, or not. We are not able to draw firm conclusions or recommend the routine use of these supplements in people with cystic fibrosis. Larger and longer studies are needed to assess the clinical benefit of omega-3 supplementation and to determine the appropriate dosage."
}
]
|
query-laysum | 4987 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a common and progressive disease characterised by chronic cough, airflow limitation and recurrent exacerbations. Since COPD exacerbations are linked to rising mortality and reduced quality of life, the condition poses a substantial burden on individuals, society and the healthcare system. Effective management of COPD exacerbations that includes treatment of related conditions in people with COPD is thus recognised as a relevant clinical question and an important research topic. Gastroesophageal reflux disease (GERD) is a known comorbidity of COPD, and pulmonary microaspiration of gastric acid is thought to be a possible cause of COPD exacerbations. Therefore, reducing gastric acid secretion may lead to a reduction in COPD exacerbations. Proton pump inhibitors (PPIs) are one of the most commonly prescribed medications and are recommended as first-line therapy for people with GERD because of their inhibitory effects on gastric acid secretion. Treatment with PPIs may present a viable treatment option for people with COPD.\nObjectives\nTo evaluate the efficacy and safety of PPI administration for people with COPD, focusing on COPD-specific outcomes.\nSearch methods\nWe searched the Cochrane Airways Register of Trials and conventional clinical trial registers from inception to 22 May 2020. We also screened bibliographies of relevant studies.\nSelection criteria\nParallel-group and cluster-randomised controlled trials (RCTs) that compared oral PPIs versus placebo, usual care or low-dose PPIs in adults with COPD were eligible for inclusion. We excluded cross-over RCTs, as well as studies with a duration of less than two months.\nData collection and analysis\nTwo independent review authors screened search results, selected studies for inclusion, extracted study characteristics and outcome data, and assessed risk of bias according to standard Cochrane methodology. We resolved discrepancies by involving a third review author. Primary outcomes of interest were COPD exacerbations, pneumonia and other serious adverse events. Secondary outcomes were quality of life, lung function test indices, acute respiratory infections and disease-specific adverse events. We extracted data on these outcome measures and entered into them into Review Manager software for analysis.\nMain results\nThe search identified 99 records, and we included one multicentre RCT that randomised 103 adults with COPD. The 12-month RCT compared an oral PPI (lansoprazole) and usual care versus usual care alone. It was conducted at one tertiary care hospital and three secondary care hospitals in Japan. This study recruited participants with a mean age of 75 years, and excluded people with symptoms or history of GERD. No placebo was used in the usual care arm.\nAmong the primary and secondary outcomes of this review, the study only reported data on COPD exacerbations and acute respiratory infections (the common cold). As we only included one study, we could not conduct a meta-analysis.\nThe included study reported that 12 of the 50 people on lansoprazole had at least one exacerbation over a year, compared to 26 out of 50 on usual care (risk ratio 0.46, 95% CI 0.26 to 0.81). The frequency of COPD exacerbations per person in a year was also lower in the PPI plus usual care group than in the usual care alone group（0.34 ± 0.72 vs 1.18 ± 1.40; P < 0.001). The number of people with at least one cold over the year was similar in both groups: 26 people on lansoprazole and 27 people in the usual care group. We judged the evidence to be of low to very low certainty, according to GRADE criteria.\nThe study reported no data on pneumonia and other serious adverse events, quality of life, lung function test indices or disease-specific adverse events. The risk of bias was largely low or unclear for the majority of domains, though the performance bias was a high risk, as the study was not blinded.\nAuthors' conclusions\nEvidence identified by this review is insufficient to determine whether treatment with PPIs is a potential option for COPD. The sample size of the included trial is small, and the evidence is low to very low-certainty. The efficacy and safety profile of PPIs for people with COPD remains uncertain. Future large-scale, high-quality studies are warranted, which investigate major clinical outcomes such as COPD exacerbation rate, serious adverse events and quality of life.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Giving PPIs to people with COPD may reduce the frequency of COPD exacerbations. However, further high-quality studies are needed to be more certain. Future studies should include different types of PPIs."
}
]
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query-laysum | 4988 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is one in a series of Cochrane reviews investigating pain management for childbirth. These reviews all contribute to an overview of systematic reviews of pain management for women in labour, and share a generic protocol. This review updates an earlier version of the review of the same title.\nObjectives\nTo examine the effectiveness and safety of hypnosis for pain management during labour and childbirth.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 September 2015) and the reference lists of primary studies and review articles.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTS comparing preparation for labour using hypnosis and/or use of hypnosis during labour, with or without concurrent use of pharmacological or non-pharmacological pain relief methods versus placebo, no treatment or any analgesic drug or technique.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality. Where possible we contacted study authors seeking additional information about data and methodology.\nMain results\nWe included nine trials randomising a total of 2954 women. The risk of bias in trials was variable, there were several well-designed large trials and some trials where little was reported about trial design. Although eight of the nine trials assessed antenatal hypnotherapy, there were considerable differences between these trials in timing and technique. One trial provided hypnotherapy during labour. In this updated review we compared hypnosis interventions with all control groups (main comparison) and also with specific control conditions: standard care (nine RCTs), supportive counselling (two RCTs) and relaxation training (two RCTs).\nIn the main comparison, women in the hypnosis group were less likely to use pharmacological pain relief or analgesia than those in the control groups, (average risk ratio (RR) 0.73, 95% CI 0.57 to 0.94, eight studies, 2916 women; very low-quality evidence; random-effects model). There were no clear differences between women in the hypnosis group and those in the control groups for most of the other primary outcomes. There were no clear differences for sense of coping with labour (MD 0.22, 95% CI -0.14 to 0.58, one study, 420 women; low-quality evidence) or spontaneous vaginal birth (average RR 1.12, 95% CI 0.96 to 1.32, six studies, 2361 women; low-quality evidence; random-effects model). There were no clear differences for satisfaction with pain relief (measured on a seven-point scale two weeks postnatally) for women in the hypnosis group who also received pethidine (MD 0.41, 95% CI -0.45 to 1.27; one study, 72 women), Entonox (MD 0.19, 95% CI -0.19 to 0.57; one study, 357 women), self-hypnosis (MD 0.28, 95% CI -0.32 to 0.88; one study, 160 women), or epidural (MD -0.03, 95% CI -0.40 to 0.34; one study, 127 women), but a slight benefit in favour of hypnosis was seen for women who received water immersion (MD 0.52, 95% CI 0.04 to 1.00; one study, 174 women (all low-quality evidence). There were no clear differences for satisfaction with pain relief when it was measured as the number of women who reported they had adequate pain relief (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20, one study, 264 women; low-quality evidence). It should be noted that for pharmacological pain relief and spontaneous vaginal birth, there was evidence of considerable statistical heterogeneity, which could not be fully explained by subgroup analysis.\nFor this review's secondary outcomes, no clear differences were found between women in the hypnosis group and women in the control groups for most outcomes where data were available. There was mixed evidence regarding benefits for women in the hypnosis group compared with all control groups for pain intensity, satisfaction with childbirth experience and postnatal depression. For each of these outcomes, data from more than one trial were available for analysis but could not be combined due to differences in measurement methods. There was evidence that fewer women in the hypnosis group stayed in hospital for more than two days after the birth but this finding was based on one small study (RR 0.11, 95% CI 0.02 to 0.83). No clear differences between women in the hypnosis group and the control groups were found for the other secondary outcomes where data were available.\nIn the comparisons of hypnosis with specific types of control conditions: standard care, supportive counselling and relaxation training, there were no clear differences found between women in the hypnosis group and those in the standard care control groups or the relaxation control groups for the primary outcomes. Compared with the women in the supportive counselling control group, women in the hypnosis group were less likely to use pharmacological analgesia (average RR 0.48, 95% CI 0.32 to 0.73, two studies, 562 women). They were also more likely to have a spontaneous vaginal birth (RR 2.42, 95% CI 1.43 to 4.07), although this finding was based on the results of one small study. Overall these new comparisons displayed much less statistical heterogeneity than the comparison including all control groups.\nAuthors' conclusions\nThere are still only a relatively small number of studies assessing the use of hypnosis for labour and childbirth. Hypnosis may reduce the overall use of analgesia during labour, but not epidural use. No clear differences were found between women in the hypnosis group and those in the control groups for satisfaction with pain relief, sense of coping with labour or spontaneous vaginal birth. Not enough evidence currently exists regarding satisfaction with pain relief or sense of coping with labour and we would encourage any future research to prioritise the measurement of these outcomes. The evidence for the main comparison was assessed using GRADE as being of low quality for all the primary outcomes with downgrading decisions due to concerns regarding inconsistency of the evidence, limitations in design and imprecision. Further research is needed in the form of large, well-designed randomised controlled trials to assess whether hypnosis is of value for pain management during labour and childbirth.\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": "Women's experiences of pain in labour are variable and complex. Techniques such as hypnosis have been proposed as ways to help women cope with pain during labour. Hypnosis represents an aspect of conscious awareness similar to daydreaming and involves focusing attention inwards and increased responsiveness to suggestions. Suggestions are verbal and non-verbal communications, that may influence perceptions (such as the way contractions are experienced), mood or behaviour. During childbirth women may use hypnosis in a range of ways; to promote relaxation, as a means of dissociating from pain or to change their perceptions, for example, perceIving contractions as a way to get closer to birthing their baby rather than an experience of pain and suffering more usually associated with injury and disability. Women can be guided into hypnosis by a practitioner during labour or individuals can learn self-hypnosis during pregnancy, for subsequent use during labour. This training on how to use hypnosis during the pregnancy is sometimes supplemented by audio recordings of hypnotic suggestions."
}
]
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query-laysum | 4989 | [
{
"role": "user",
"content": "Abstract: Background\nHepatic encephalopathy is a common and devastating neuropsychiatric complication of acute liver failure or chronic liver disease. Ammonia content in the blood seems to play a role in the development of hepatic encephalopathy. Treatment for hepatic encephalopathy is complex. Acetyl-L-carnitine is a substance that may reduce ammonia toxicity. This review assessed the benefits and harms of acetyl-L-carnitine for patients with hepatic encephalopathy.\nObjectives\nTo assess the benefits and harms of acetyl-L-carnitine for patients with hepatic encephalopathy.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, and Science Citation Index Expanded for randomised clinical trials. We sought additional randomised clinical trials from the World Health Organization Clinical Trials Search Portal and ClinicalTrials.gov. We performed all electronic searches until 10 September 2018. We looked through the reference lists of retrieved publications and review articles, and we searched the FDA and EMA websites.\nSelection criteria\nWe searched for randomised clinical trials in any setting, recruiting people with hepatic encephalopathy. Trials were eligible for inclusion if they compared acetyl-L-carnitine plus standard care (e.g. antibiotics, lactulose) versus placebo or no acetyl-L-carnitine plus standard care. We are well aware that by selecting randomised clinical trials, we placed greater focus on potential benefits than on potential harms.\nData collection and analysis\nWe selected randomised clinical trials, assessed risk of bias in eight domains, and extracted data in a duplicate and independent fashion. We estimated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. We measured statistical heterogeneity using I² and D² statistics. We subjected our analyses to fixed-effect and random-effects model meta-analyses. We assessed bias risk domains to control systematic errors. We assessed overall quality of the data for each individual outcome by using the GRADE approach.\nMain results\nWe identified five randomised clinical trials involving 398 participants. All trials included only participants with cirrhosis as the underlying cause of hepatic encephalopathy. Trials included participants with covert or overt hepatic encephalopathy. All trials were conducted in Italy by a single team and assessed acetyl-L-carnitine compared with placebo. Oral intervention was the most frequent route of administration. All trials were at high risk of bias and were underpowered. None of the trials were sponsored by the pharmaceutical industry.\nNone of the identified trials reported information on all-cause mortality, serious adverse events, or days of hospitalisation. Only one trial assessed quality of life using the Short Form (SF)-36 scale (67 participants; very low-quality evidence). The effects of acetyl-L-carnitine compared with placebo on general health at 90 days are uncertain (MD -6.20 points, 95% confidence interval (CI) -9.51 to -2.89). Results for additional domains of the SF-36 are also uncertain. One trial assessed fatigue using the Wessely and Powell test (121 participants; very low-quality evidence). The effects are uncertain in people with moderate-grade hepatic encephalopathy (mental fatigue: MD 0.40 points, 95% CI -0.21 to 1.01; physical fatigue: MD -0.20 points, 95% CI -0.92 to 0.52) and mild-grade hepatic encephalopathy (mental fatigue: -0.80 points, 95% CI -1.48 to -0.12; physical fatigue: 0.20 points, 95% CI -0.72 to 1.12). Meta-analysis showed a reduction in blood ammonium levels favouring acetyl-L-carnitine versus placebo (MD -13.06 mg/dL, 95% CI -17.24 to -8.99; 387 participants; 5 trials; very low-quality evidence). It is unclear whether acetyl-L-carnitine versus placebo increases the risk of non-serious adverse events (8/126 (6.34%) vs 3/120 (2.50%); RR 2.51, 95% CI 0.68 to 9.22; 2 trials; very low-quality evidence). Overall, adverse events data were poorly reported and harms may have been underestimated.\nAuthors' conclusions\nThis Cochrane systematic review analysed a heterogeneous group of five trials at high risk of bias and with high risk of random errors conducted by only one research team. We assessed acetyl-L-carnitine versus placebo in participants with cirrhosis with covert or overt hepatic encephalopathy. Hence, we have no data on the drug for hepatic encephalopathy in acute liver failure. We found no information about all-cause mortality, serious adverse events, or days of hospitalisation. We found no clear differences in effect between acetyl-L-carnitine and placebo regarding quality of life, fatigue, and non-serious adverse events. Acetyl-L-carnitine reduces blood ammonium levels compared with placebo. We rated all evidence as of very low quality due to pitfalls in design and execution, inconsistency, small sample sizes, and very few events. The harms profile for acetyl-L-carnitine is presently unclear. Accordingly, we need further randomised clinical trials to assess acetyl-L-carnitine versus placebo conducted according to the SPIRIT statements and reported according to the CONSORT statements.\n\nGiven the provided abstract, please respond to the following query: \"Findings of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors searched the medical literature up to 10 September 2018, and identified five relevant randomised clinical trials, including a total of 398 participants. All trials were performed in Italy by only one team of investigators. All were considered at high risk of bias and included small numbers of participants, which makes potential overestimation of benefits and underestimation of harms likely. The pharmaceutical industry did not sponsor any trial. Trials tested acetyl-L-carnitine given orally or intravenously versus placebo. The drug did not seem to have effects on quality of life, fatigue, or non-serious adverse events when compared with placebo (inactive sham drug)."
}
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query-laysum | 4990 | [
{
"role": "user",
"content": "Abstract: Background\nPilonidal sinus disease is a common condition that mainly affects young adults. This condition can cause significant pain and impairment of normal activities. No consensus currently exists on the optimum treatment for pilonidal sinus and current therapies have various advantages and disadvantages. Fibrin glue has emerged as a potential treatment as both monotherapy and an adjunct to surgery.\nObjectives\nTo assess the effects of fibrin glue alone or in combination with surgery compared with surgery alone in the treatment of pilonidal sinus disease.\nSearch methods\nIn December 2016 we searched: the Cochrane Wounds Specialised Register; CENTRAL; MEDLINE; Embase and CINAHL Plus. We also searched clinical trials registries and conference proceedings for ongoing and unpublished studies and scanned reference lists to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) only. We included studies involving participants of all ages and studies conducted in any setting. We considered studies involving people with both new and recurrent pilonidal sinus. We included studies which evaluated fibrin glue monotherapy or as an adjunct to surgery.\nData collection and analysis\nTwo study authors independently extracted data and assessed risk of bias. We used standard methods expected by Cochrane.\nMain results\nWe included four RCTs with 253 participants, all were at risk of bias. One unpublished study evaluated fibrin glue monotherapy compared with Bascom's procedure, two studies evaluated fibrin glue as an adjunct to Limberg flap and one study evaluated fibrin glue as an adjunct to Karydakis flap.\nFor fibrin glue monotherapy compared with Bascom's procedure, there were no data available for the primary outcomes of time to healing and adverse events. There was low-quality evidence of less pain on day one after the procedure with fibrin glue monotherapy compared with Bascom's procedure (mean difference (MD) -2.50, 95% confidence interval (CI) -4.03 to -0.97) (evidence downgraded twice for risk of performance and detection bias). Fibrin glue may reduce the time taken to return to normal activities compared with Bascom's procedure (mean time 42 days with surgery and 7 days with glue, MD -34.80 days, 95% CI -66.82 days to -2.78 days) (very low-quality evidence, downgraded as above and for imprecision).\nFibrin glue as an adjunct to the Limberg flap may reduce the healing time from 22 to 8 days compared with the Limberg flap alone (MD -13.95 days, 95% CI -16.76 days to -11.14 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). It is uncertain whether use of fibrin glue affects the incidence of postoperative seroma (an adverse event) (risk ratio (RR) 0.27, 95% CI 0.05 to 1.61; very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). There was low-quality evidence that fibrin glue, as an adjunct to Limberg flap, may reduce postoperative pain (median 2 versus 4; P < 0.001) and time to return to normal activities (median 8 days versus 17 days; P < 0.001). The addition of fibrin glue to the Limberg flap may reduce the length of hospital stay (MD -1.69 days, 95% CI -2.08 days to -1.29 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for unexplained heterogeneity).\nA single RCT evaluating fibrin glue as an adjunct to the Karydakis flap did not report data for the primary outcome of time to healing. It is uncertain whether fibrin glue with the Karydakis flap affects the incidence of postoperative seroma (adverse event) (RR 3.00, 95% CI 0.67 to 13.46) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for imprecision). Fibrin glue as an adjunct to Karydakis flap may reduce length of stay but this is highly uncertain (mean 2 days versus 3.7 days; P < 0.001, low-quality evidence downgraded twice for risk of selection, performance and detection bias).\nAuthors' conclusions\nCurrent evidence is uncertain regarding any benefits associated with fibrin glue either as monotherapy or as an adjunct to surgery for people with pilonidal sinus disease. We identified only four RCTs and each was small and at risk of bias resulting in very low-quality evidence for the primary outcomes of time to healing and adverse events. Future studies should enrol many more participants, ensure adequate randomisation and blinding, whilst measuring clinically relevant outcomes.\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": "In December 2016 we searched for randomised controlled trials involving participants of any age or sex, whose pilonidal sinus had been treated with fibrin glue, either on its own or with surgery. We found four studies that included 253 participants, the majority of whom were male. Fibrin glue on its own was compared with surgery in one study. In three studies fibrin glue was applied during surgery and compared with surgery on its own. There were problems with the design and conduct of all four studies which mean that their results are very uncertain."
}
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query-laysum | 4991 | [
{
"role": "user",
"content": "Abstract: Background\nLipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.\nObjectives\nTo assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and CINAHL up to 3 February 2016, and clinical trials registers (ANZCTR and ClinicalTrials.gov) up to 27 July 2016. We applied no language restrictions.\nSelection criteria\nWe evaluated randomised controlled trials of adherence-enhancing interventions for lipid-lowering medication in adults in an ambulatory setting with a variety of measurable outcomes, such as adherence to treatment and changes to serum lipid levels. Two teams of review authors independently selected the studies.\nData collection and analysis\nThree review authors extracted and assessed data, following criteria outlined by the Cochrane Handbook for Systematic Reviews of Interventions. We assessed the quality of the evidence using GRADEPro.\nMain results\nFor this updated review, we added 24 new studies meeting the eligibility criteria to the 11 studies from prior updates. We have therefore included 35 studies, randomising 925,171 participants. Seven studies including 11,204 individuals compared adherence rates of those in an intensification of a patient care intervention (e.g. electronic reminders, pharmacist-led interventions, healthcare professional education of patients) versus usual care over the short term (six months or less), and were pooled in a meta-analysis. Participants in the intervention group had better adherence than those receiving usual care (odds ratio (OR) 1.93, 95% confidence interval (CI) 1.29 to 2.88; 7 studies; 11,204 participants; moderate-quality evidence). A separate analysis also showed improvements in long-term adherence rates (more than six months) using intensification of care (OR 2.87, 95% CI 1.91 to 4.29; 3 studies; 663 participants; high-quality evidence). Analyses of the effect on total cholesterol and LDL-cholesterol levels also showed a positive effect of intensified interventions over both short- and long-term follow-up. Over the short term, total cholesterol decreased by a mean of 17.15 mg/dL (95% CI 1.17 to 33.14; 4 studies; 430 participants; low-quality evidence) and LDL-cholesterol decreased by a mean of 19.51 mg/dL (95% CI 8.51 to 30.51; 3 studies; 333 participants; moderate-quality evidence). Over the long term (more than six months) total cholesterol decreased by a mean of 17.57 mg/dL (95% CI 14.95 to 20.19; 2 studies; 127 participants; high-quality evidence). Included studies did not report usable data for health outcome indications, adverse effects or costs/resource use, so we could not pool these outcomes. We assessed each included study for bias using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. In general, the risk of bias assessment revealed a low risk of selection bias, attrition bias, and reporting bias. There was unclear risk of bias relating to blinding for most studies.\nAuthors' conclusions\nThe evidence in our review demonstrates that intensification of patient care interventions improves short- and long-term medication adherence, as well as total cholesterol and LDL-cholesterol levels. Healthcare systems which can implement team-based intensification of patient care interventions may be successful in improving patient adherence rates to lipid-lowering medicines.\n\nGiven the provided abstract, please respond to the following query: \"Search\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our search included the 11 studies identified from previous versions in 2004 and 2010. We conducted an updated search of the same electronic databases on 3 February 2016, and we searched clinical trials registers up to 27 July 2016."
}
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query-laysum | 4992 | [
{
"role": "user",
"content": "Abstract: Background\nPhysical exercise training might improve muscle and cardiorespiratory function in spinal muscular atrophy (SMA). Optimization of aerobic capacity or other resources in residual muscle tissue through exercise may counteract the muscle deterioration that occurs secondary to motor neuron loss and inactivity in SMA. There is currently no evidence synthesis available on physical exercise training in people with SMA type 3.\nObjectives\nTo assess the effects of physical exercise training on functional performance in people with SMA type 3, and to identify any adverse effects.\nSearch methods\nOn 8 May 2018, we searched the Cochrane Neuromuscular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, AMED, and LILACS. On 25 April 2018 we searched NHSEED, DARE, and ClinicalTrials.gov and WHO ICTRP for ongoing trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs lasting at least 12 weeks that compared physical exercise training (strength training, aerobic exercise training, or both) to placebo, standard or usual care, or another type of non-physical intervention for SMA type 3. Participants were adults and children from the age of five years with a diagnosis of SMA type 3 (Kugelberg-Welander syndrome), confirmed by genetic analysis.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included one RCT that studied the effects of a six-month, home-based, combined muscle strength and recumbent cycle ergometry training program versus usual care in 14 ambulatory people with SMA. The age range of the participants was between 10 years and 48 years. The study was evaluator-blinded, but personnel and participants could not be blinded to the intervention, which placed the results at a high risk of bias. Participants performed strength training as prescribed, but 50% of the participants did not achieve the intended aerobic exercise training regimen. The trial used change in walking distance on the six-minute walk test as a measure of function; a minimal detectable change is 24.0 m. The change from baseline to six months' follow-up in the training group (9.4 m) was not detectably different from the change in the usual care group (-0.14 m) (mean difference (MD) 9.54 m, 95% confidence interval (CI) -83.04 to 102.12; N = 12). Cardiopulmonary exercise capacity, assessed by the change from baseline to six months' follow-up in peak oxygen uptake (VO2max) was similar in the training group (-0.12 mL/kg/min) and the usual care group (-1.34 mL/kg/min) (MD 1.22 mL/kg/min, 95% CI -2.16 to 4.6; N = 12). A clinically meaningful increase in VO2max is 3.5 mL/kg/min.\nThe trial assessed function on the Hammersmith Functional Motor Scale - Expanded (HFMSE), which has a range of possible scores from 0 to 66, with an increase of 3 or more points indicating clinically meaningful improvement. The HFMSE score in the training group increased by 2 points from baseline to six months' follow-up, with no change in the usual care group (MD 2.00, 95% CI -2.06 to 6.06; N = 12). The training group showed a slight improvement in muscle strength, expressed as the manual muscle testing (MMT) total score, which ranges from 28 (weakest) to 280 (strongest). The change from baseline in MMT total score was 6.8 in the training group compared to -5.14 in the usual care group (MD 11.94, 95% CI -3.44 to 27.32; N = 12).\nThe trial stated that training had no statistically significant effects on fatigue and quality of life. The certainty of evidence for all outcomes was very low because of study limitations and imprecision. The study did not assess the effects of physical exercise training on physical activity levels. No study-related serious adverse events or adverse events leading to withdrawal occurred, but we cannot draw wider conclusions from this very low-certainty evidence.\nAuthors' conclusions\nIt is uncertain whether combined strength and aerobic exercise training is beneficial or harmful in people with SMA type 3, as the quality of evidence is very low. We need well-designed and adequately powered studies using protocols that meet international standards for the development of training interventions, in order to improve our understanding of the exercise response in people with SMA type 3 and eventually develop exercise guidelines for this condition.\n\nGiven the provided abstract, please respond to the following query: \"Key results and certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Participants performed strength training as prescribed, but only half of them completed the full aerobic exercise program.\nThe effects of physical exercise training in people with SMA type 3 remain unclear, as the evidence is very uncertain."
}
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query-laysum | 4993 | [
{
"role": "user",
"content": "Abstract: Background\nMolluscum contagiosum is a common skin infection that is caused by a pox virus and occurs mainly in children. The infection usually resolves within months in people without immune deficiency, but treatment may be preferred for social and cosmetic reasons or to avoid spreading the infection. A clear evidence base supporting the various treatments is lacking.\nThis is an update of a Cochrane Review first published in 2006, and updated previously in 2009.\nObjectives\nTo assess the effects of specific treatments and management strategies, including waiting for natural resolution, for cutaneous, non-genital molluscum contagiosum in people without immune deficiency.\nSearch methods\nWe updated our searches of the following databases to July 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched six trial registers and checked the reference lists of included studies and review articles for further references to relevant randomised controlled trials. We contacted pharmaceutical companies and experts in the field to identify further relevant randomised controlled trials.\nSelection criteria\nRandomised controlled trials of any treatment of molluscum contagiosum in people without immune deficiency. We excluded trials on sexually transmitted molluscum contagiosum and in people with immune deficiency (including those with HIV infection).\nData collection and analysis\nTwo review authors independently selected studies, assessed methodological quality, and extracted data from selected studies. We obtained missing data from study authors where possible.\nMain results\nWe found 11 new studies for this update, resulting in 22 included studies with a total of 1650 participants. The studies examined the effects of topical (20 studies) and systemic interventions (2 studies).\nAmong the new included studies were the full trial reports of three large unpublished studies, brought to our attention by an expert in the field. They all provided moderate-quality evidence for a lack of effect of 5% imiquimod compared to vehicle (placebo) on short-term clinical cure (4 studies, 850 participants, 12 weeks after start of treatment, risk ratio (RR) 1.33, 95% confidence interval (CI) 0.92 to 1.93), medium-term clinical cure (2 studies, 702 participants, 18 weeks after start of treatment, RR 0.88, 95% CI 0.67 to 1.14), and long-term clinical cure (2 studies, 702 participants, 28 weeks after start of treatment, RR 0.97, 95% CI 0.79 to 1.17). We found similar but more certain results for short-term improvement (4 studies, 850 participants, 12 weeks after start of treatment, RR 1.14, 95% CI 0.89 to 1.47; high-quality evidence). For the outcome 'any adverse effect', we found high-quality evidence for little or no difference between topical 5% imiquimod and vehicle (3 studies, 827 participants, RR 0.97, 95% CI 0.88 to 1.07), but application site reactions were more frequent in the groups treated with imiquimod (moderate-quality evidence): any application site reaction (3 studies, 827 participants, RR 1.41, 95% CI 1.13 to 1.77, the number needed to treat for an additional harmful outcome (NNTH) was 11); severe application site reaction (3 studies, 827 participants, RR 4.33, 95% CI 1.16 to 16.19, NNTH over 40).\nFor the following 11 comparisons, there was limited evidence to show which treatment was superior in achieving short-term clinical cure (low-quality evidence): 5% imiquimod less effective than cryospray (1 study, 74 participants, RR 0.60, 95% CI 0.46 to 0.78) and 10% potassium hydroxide (2 studies, 67 participants, RR 0.65, 95% CI 0.46 to 0.93); 10% Australian lemon myrtle oil more effective than olive oil (1 study, 31 participants, RR 17.88, 95% CI 1.13 to 282.72); 10% benzoyl peroxide cream more effective than 0.05% tretinoin (1 study, 30 participants, RR 2.20, 95% CI 1.01 to 4.79); 5% sodium nitrite co-applied with 5% salicylic acid more effective than 5% salicylic acid alone (1 study, 30 participants, RR 3.50, 95% CI 1.23 to 9.92); and iodine plus tea tree oil more effective than tea tree oil (1 study, 37 participants, RR 0.20, 95% CI 0.07 to 0.57) or iodine alone (1 study, 37 participants, RR 0.07, 95% CI 0.01 to 0.50). Although there is some uncertainty, 10% potassium hydroxide appears to be more effective than saline (1 study, 20 participants, RR 3.50, 95% CI 0.95 to 12.90); homeopathic calcarea carbonica appears to be more effective than placebo (1 study, 20 participants, RR 5.57, 95% CI 0.93 to 33.54); 2.5% appears to be less effective than 5% solution of potassium hydroxide (1 study, 25 participants, RR 0.35, 95% CI 0.12 to 1.01); and 10% povidone iodine solution plus 50% salicylic acid plaster appears to be more effective than salicylic acid plaster alone (1 study, 30 participants, RR 1.43, 95% CI 0.95 to 2.16).\nWe found no statistically significant differences for other comparisons (most of which addressed two different topical treatments). We found no randomised controlled trial evidence for expressing lesions or topical hydrogen peroxide.\nStudy limitations included no blinding, many dropouts, and no intention-to-treat analysis. Except for the severe application site reactions of imiquimod, none of the evaluated treatments described above were associated with serious adverse effects (low-quality evidence). Among the most common adverse events were pain during application, erythema, and itching. Included studies of the following comparisons did not report adverse effects: calcarea carbonica versus placebo, 10% povidone iodine plus 50% salicylic acid plaster versus salicylic acid plaster, and 10% benzoyl peroxide versus 0.05% tretinoin.\nWe were unable to judge the risk of bias in most studies due to insufficient information, especially regarding concealment of allocation and possible selective reporting. We considered five studies to be at low risk of bias.\nAuthors' conclusions\nNo single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum. We found moderate-quality evidence that topical 5% imiquimod was no more effective than vehicle in terms of clinical cure, but led to more application site reactions, and high-quality evidence that there was no difference between the treatments in terms of short-term improvement. However, high-quality evidence showed a similar number of general side effects in both groups. As the evidence found did not favour any one treatment, the natural resolution of molluscum contagiosum remains a strong method for dealing with the condition.\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 many common treatments for molluscum, such as physical destruction, have not been adequately evaluated. Some of the included treatments are not part of standard practice.\nWe found moderate-quality evidence that topical 5% imiquimod is probably no more effective than vehicle (i.e. the same cream but without imiquimod) in achieving short-, medium-, and long-term clinical cure. High-quality (and thus more certain) evidence showed that topical 5% imiquimod is no better than placebo at improving molluscum up to three months after the start of treatment.\nHigh-quality evidence showed that 5% imiquimod differed little or not at all in the number of side effects compared to vehicle. However, moderate-quality evidence suggests that there are probably more application site reactions when using topical 5% imiquimod compared with vehicle.\nLow-quality evidence, based on one or two mostly small studies, revealed the following results for the outcome short-term clinical cure: 5% imiquimod less effective than cryospray or 10% potassium hydroxide; 10% Australian lemon myrtle oil more effective than olive oil; 10% benzoyl peroxide cream more effective than 0.05% tretinoin; 5% sodium nitrite co-applied with 5% salicylic acid more effective than 5% salicylic acid alone; and iodine plus tea tree oil more effective than tea tree oil or iodine alone. We found more uncertain (low-quality) evidence to suggest that 10% potassium hydroxide is more effective than saline; homeopathic calcarea carbonica is more effective than placebo; 2.5% solution of potassium hydroxide is less effective than 5% solution of potassium hydroxide; and 10% povidone iodine solution and 50% salicylic acid plaster are more effective than salicylic acid plaster alone.\nExcept for the severe application site reactions of imiquimod, none of these treatments led to serious adverse effects (low-quality evidence). Pain during treatment application, redness, and itching were among the most reported adverse effects.\nWe found no differences between the treatments assessed in the other comparisons.\nWe found no randomised trials for several commonly used treatments, such as expressing lesions with an orange stick or topical hydrogen peroxide. Since most lesions resolve within months, unless better evidence for the superiority of active treatments emerges, molluscum contagiosum can be left to heal naturally."
}
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query-laysum | 4994 | [
{
"role": "user",
"content": "Abstract: Background\nLong-acting reversible contraception (LARC), including intrauterine devices (IUDs) and contraceptive implants, are highly effective, reversible methods of contraception. Providing LARC methods during the postpartum period is important to support contraceptive choice, and to prevent unintended pregnancy and short interpregnancy intervals. Delaying offering contraception to postpartum people until the first comprehensive postpartum visit, traditionally at around six weeks postpartum, may put some postpartum people at risk of unintended pregnancy, either due to loss to follow-up or because of initiation of sexual intercourse prior to receiving contraception. Therefore, immediate provision of highly effective contraception, prior to discharge from hospital, has the potential to improve contraceptive use and prevent unintended pregnancies and short interpregnancy intervals.\nObjectives\nTo compare the initiation rate, utilization rates (at six months and 12 months after delivery), effectiveness, and adverse effects of immediate versus delayed postpartum insertion of implants and IUDs for contraception.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE for eligible studies up to December 2020. We examined review articles and contacted investigators. We checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies.\nSelection criteria\nWe sought randomized controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant and IUDs for contraception.\nData collection and analysis\nTwo review authors (JS, SK) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL, SA or PP). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel or inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables.\nMain results\nIn this updated review, 16 studies met the inclusion criteria; five were studies of contraceptive implants (715 participants) and 11 were studies of IUDs (1894 participants). We identified 12 ongoing studies. We applied GRADE judgements to our results; the overall certainty of the evidence for each outcome ranged from moderate to very low, with the main limitations being risk of bias, inconsistency, and imprecision.\nContraceptive implants\nImmediate insertion probably improves the initiation rate for contraceptive implants compared with delayed insertion (RR 1.48, 95% CI 1.11 to 1.98; 5 studies, 715 participants; I2 = 95%; moderate-certainty evidence).\nWe are uncertain if there was a difference between the two groups for the utilization rate of contraceptive implants at six months after delivery (RR 1.16, 95% CI 0.90 to 1.50; 3 studies, 330 participants; I2 = 89%; very low-certainty evidence) or at 12 months after insertion (RR 0.98, 95% CI 0.93 to 1.04; 2 studies, 164 participants; I2 = 0%; very low-certainty evidence).\nPeople who received an immediate postpartum contraceptive implant insertion may have had a higher mean number of days of prolonged vaginal bleeding within six weeks postpartum (mean difference (MD) 2.98 days, 95% CI -2.71 to 8.66; 2 studies, 420 participants; I2 = 91%; low-certainty evidence) and a higher rate of other adverse effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; 1 study, 215 participants; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups for prolonged bleeding at six months after delivery (RR 1.19, 95% CI 0.29 to 4.94; 2 studies, 252 participants; I2 = 0%; very low-certainty evidence).\nThere may be little or no difference between the two groups for rates of unintended pregnancy at six months (RR 0.20, 95% CI 0.01 to 4.08; one study, 205 participants; low-certainty evidence). We are uncertain whether there was a difference in rates of unintended pregnancy at 12 months postpartum (RR 1.82, 95% CI 0.38 to 8.71; 1 study, 64 participants; very low-certainty evidence). There may be little or no difference between the two groups for any breastfeeding rates at six months (RR 0.97, 95% CI 0.92 to 1.01; 2 studies, 225 participants; I2 = 48%; low-certainty evidence).\nIUDs\nImmediate insertion of IUDs probably improves the initiation rate compared with delayed insertion, regardless of type of IUD (RR 1.27, 95% CI 1.07 to 1.51; 10 studies, 1894 participants; I2 = 98%; moderate-certainty evidence). However, people who received an immediate postpartum IUD insertion may have had a higher expulsion rate at six months after delivery (RR 4.55, 95% CI 2.52 to 8.19; 8 studies, 1206 participants; I2 = 31%; low-certainty evidence) than those who received a delayed postpartum insertion.\nWe are uncertain if there was a difference between the two groups in the utilization of IUDs at six months after insertion (RR 1.02, 95% CI 0.65 to 1.62; 6 studies, 971 participants; I2 = 96%; very low-certainty evidence) or at 12 months after insertion (RR 0.86, 95% CI 0.5 to 1.47; 3 studies, 796 participants; I2 = 92%; very low-certainty evidence).\nImmediate IUDs insertion may reduce unintended pregnancy at 12 months (RR 0.26, 95% CI 0.17 to 0.41; 1 study, 1000 participants; low-certainty evidence). We are uncertain whether there was difference in any breastfeeding rates at six months in people receiving progestin-releasing IUDs (RR 0.90, 95% CI 0.63 to 1.30; 5 studies, 435 participants; I2 = 54%; very low-certainty evidence).\nAuthors' conclusions\nEvidence from this updated review indicates that immediate postpartum insertion improves the initiation rate of both contraceptive implants and IUDs by the first postpartum visit compared to delayed insertion. However, it is not clear whether that there are differences in utilization rates at six and 12 months postpartum. We are uncertain whether there is any difference in the unintended pregnancy rate at 12 months. Provision of progestin-releasing implants and IUDs immediately postpartum may have little or no negative impact on breastfeeding. However, the expulsion rate of IUDs and prolonged vaginal bleeding associated with immediate implants appears to be higher.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Contraceptive implants\nPeople were 48% more likely to have contraceptive implants inserted when they could be inserted within days of childbirth compared to delayed insertion.\nThe timing of insertion made little or no difference to the number of people using contraceptive implants 6 or 12 months after childbirth.\nVaginal bleeding seemed to last longer in people who had implants inserted a few days after childbirth compared to delayed insertion (3 days more bleeding), but there was no difference between groups for bleeding 6 months after childbirth.\nWe are uncertain if there was a difference in rates of unintended pregnancy between the groups at 6 and 12 months after childbirth.\nIUDs\nPeople were 27% more likely to have IUDs inserted when they could be inserted within days of childbirth compared to delayed insertion.\nIt was unclear whether the timing of insertion made any difference to the number of people using IUDs 6 or 12 months after childbirth.\nSix months after childbirth, expulsion of IUDs from the womb seemed to occur more frequently in people who had had an IUD inserted within days of childbirth.\nWe are uncertain if there was a difference in rates of unintended pregnancy between the groups at 6 and 12 months after childbirth."
}
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query-laysum | 4995 | [
{
"role": "user",
"content": "Abstract: Background\nCrimean Congo haemorrhagic fever (CCHF) is a tick-borne disease that occurs in parts of Asia, Europe and Africa. Since 2000 the infection has caused epidemics in Turkey, Iran, Russia, Uganda and Pakistan. Good-quality general supportive medical care helps reduce mortality. There is uncertainty and controversy about treating CCHF with the antiviral drug ribavirin.\nObjectives\nTo assess the effects of ribavirin for treating people with Crimean Congo haemorrhagic fever.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (OVID); Science Citation Index-Expanded, Social Sciences Citation index, conference proceedings (Web of Science); and CINAHL (EBSCOHost). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials in progress. We conducted all searches up to 16 October 2017. We also contacted experts in the field and obtained further studies from these sources.\nSelection criteria\nWe evaluated studies assessing the use of ribavirin in people with suspected or confirmed Crimean Congo haemorrhagic fever. We included randomised control trials (RCTs); non-randomised studies (NRSs) that included more than 10 participants designed as cohort studies with comparators; and case-control studies.\nData collection and analysis\nTwo review authors assessed eligibility, risk of bias, and extracted data. For non-randomized studies we used the ROBINS-I tool to assess risk of bias. The main effects analysis included all studies where we judged the risk of bias to be low, moderate or high. We summarized dichotomous outcomes using risk ratios (RRs) and continuous outcomes using mean differences (MDs), and used meta-analyses where appropriate. We carried out a subsidiary appraisal and analysis of studies with critical risk of bias for the primary outcome, as these are often cited to support using ribavirin.\nMain results\nFor the main effects analysis, five studies met our inclusion criteria: one RCT with 136 participants and four non-randomized studies with 612 participants. We excluded 18 non-randomized studies with critical risk of bias, where none had attempted to control for confounding.\nWe do not know if ribavirin reduces mortality (1 RCT; RR 1.13, 95% confidence interval (CI) 0.29 to 4.32; 136 participants; very low-certainty evidence; 3 non-randomized studies; RR 0.72, 95% CI 0.41 to 1.28; 549 participants; very low-certainty evidence). We do not know if ribavirin reduces the length of stay in hospital (1 RCT: mean difference (MD) 0.70 days, 95% CI -0.39 to 1.79; 136 participants; and 1 non-randomized study: MD -0.80, 95% CI -2.70 to 1.10; 50 participants; very low-certainty evidence). We do not know if it reduces the risk of patients needing platelet transfusions (1 RCT: RR 1.23, 95% CI 0.77 to 1.96; 136 participants; very low-certainty evidence). For adverse effects (including haemolytic anaemia and a need to discontinue treatment), we do not know whether there is an increased risk with ribavirin in people with CCHF as data are insufficient.\nWe do not know if adding ribavirin to early supportive care improves outcomes. One non-randomized study assessed mortality in people receiving ribavirin and supportive care within four days or less from symptom onset compared to after four days since symptom onset: mortality was lower in the group receiving early supportive care and ribavirin, but it is not possible to distinguish between the effects of ribavirin and early supportive medical care alone.\nIn the subsidiary analysis, 18 studies compared people receiving ribavirin with those not receiving ribavirin. All had a critical risk of bias due to confounding, reflected in the mortality point estimates favouring ribavirin.\nAuthors' conclusions\nWe do not know if ribavirin is effective for treating Crimean Congo haemorrhagic fever. Non-randomized studies are often cited as evidence of an effect, but the risk of bias in these studies is high.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane review is to find out if ribavirin is an effective treatment for Crimean Congo haemorrhagic fever. Cochrane researchers collected and analysed all relevant studies to answer this question. We found 23 studies. We include five studies in this review that helped answer the question. We analysed the other 18 studies to help describe the limitations of the evidence."
}
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query-laysum | 4996 | [
{
"role": "user",
"content": "Abstract: Background\nPulmonary embolism (PE) is a potentially life-threatening condition in which a clot can migrate from the deep veins, most commonly in the leg, to the lungs. Conventional treatment of PE used unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux, and vitamin K antagonists (VKAs). Recently, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors. DOACs have characteristics that may be favourable to conventional treatment, including oral administration, a predictable effect, no need for frequent monitoring or re-dosing, and few known drug interactions. This review reports the efficacy and safety of these drugs in the long-term treatment of PE (minimum duration of three months). This is an update of a Cochrane Review first published in 2015.\nObjectives\nTo assess the efficacy and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of PE.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 2 March 2022. We checked the reference lists of relevant articles for additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which people with a PE confirmed by standard imaging techniques were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with a conventional anticoagulant or compared with each other for the long-term treatment of PE (minimum duration three months).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent PE, recurrent venous thromboembolism (VTE), and deep vein thrombosis (DVT). Secondary outcomes were all-cause mortality, major bleeding, and health-related quality of life. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified five additional RCTs with 1484 participants for this update. Together with the previously included trials, we have included ten RCTs with a total of 13,073 participants. Two studies investigated an oral DTI (dabigatran) and eight studies investigated oral factor Xa inhibitors (three rivaroxaban, three apixaban, and two edoxaban). The studies were of good methodological quality overall.\nMeta-analysis showed no clear difference in the efficacy and safety of oral DTI compared with conventional anticoagulation in preventing recurrent PE (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.50 to 2.04; 2 studies, 1602 participants; moderate-certainty evidence), recurrent VTE (OR 0.93, 95% CI 0.52 to 1.66; 2 studies, 1602 participants; moderate-certainty evidence), DVT (OR 0.79, 95% CI 0.29 to 2.13; 2 studies, 1602 participants; moderate-certainty evidence), and major bleeding (OR 0.50, 95% CI 0.15 to 1.68; 2 studies, 1527 participants; moderate-certainty evidence). We downgraded the certainty of evidence by one level for imprecision due to the low number of events.\nThere was also no clear difference between the oral factor Xa inhibitors and conventional anticoagulation in the prevention of recurrent PE (OR 0.92, 95% CI 0.66 to 1.29; 3 studies, 8186 participants; moderate-certainty evidence), recurrent VTE (OR 0.83, 95% CI 0.66 to 1.03; 8 studies, 11,416 participants; moderate-certainty evidence), DVT (OR 0.77, 95% CI 0.48 to 1.25; 2 studies, 8151 participants; moderate-certainty evidence), all-cause mortality (OR 1.16, 95% CI 0.79 to 1.70; 1 study, 4817 participants; moderate-certainty evidence) and major bleeding (OR 0.71, 95% CI 0.36 to 1.41; 8 studies, 11,447 participants; low-certainty evidence); the heterogeneity for major bleeding was significant (I2 = 79%). We downgraded the certainty of the evidence to moderate and low because of imprecision due to the low number of events and inconsistency due to clinical heterogeneity. None of the included studies measured health-related quality of life.\nAuthors' conclusions\nAvailable evidence shows there is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent PE, recurrent VTE, DVT, all-cause mortality, and major bleeding. The certainty of evidence was moderate or low. Future large clinical trials are required to identify if individual drugs differ in effectiveness and bleeding risk, and to explore effect differences in subgroups, including people with cancer and obesity.\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": "This review updates a previous Cochrane Review. The evidence is up to date to March 2022."
}
]
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query-laysum | 4997 | [
{
"role": "user",
"content": "Abstract: Background\nLiver transplantation is an established treatment option for end-stage liver failure. To date, no consensus has been reached on the use of immunosuppressive T-cell antibody induction for preventing rejection after liver transplantation.\nObjectives\nTo assess the benefits and harms of immunosuppressive T-cell specific antibody induction compared with placebo, no induction, or another type of T-cell specific antibody induction for prevention of acute rejection in liver transplant recipients.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) until September 2013.\nSelection criteria\nRandomised clinical trials assessing immunosuppression with T-cell specific antibody induction compared with placebo, no induction, or another type of antibody induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy. We planned to include trials with all of the different types of T-cell specific antibodies that are or have been used for induction (ie., polyclonal antibodies (rabbit of horse antithymocyte globulin (ATG), or antilymphocyte globulin (ALG)), monoclonal antibodies (muromonab-CD3, anti-CD2, or alemtuzumab), and interleukin-2 receptor antagonists (daclizumab, basiliximab, BT563, or Lo-Tact-1)).\nData collection and analysis\nWe used RevMan analysis for statistical analysis of dichotomous data with risk ratio (RR) and of continuous data with mean difference (MD), both with 95% confidence intervals (CIs). We assessed the risk of systematic errors (bias) using bias risk domains with definitions. We used trial sequential analysis to control for random errors (play of chance). We presented outcome results in a summary of findings table.\nMain results\nWe included 19 randomised clinical trials with a total of 2067 liver transplant recipients. All 19 trials were with high risk of bias. Of the 19 trials, 16 trials were two-arm trials, and three trials were three-arm trials. Hence, we found 25 trial comparisons with antibody induction agents: interleukin-2 receptor antagonist (IL-2 RA) versus no induction (10 trials with 1454 participants); monoclonal antibody versus no induction (five trials with 398 participants); polyclonal antibody versus no induction (three trials with 145 participants); IL-2 RA versus monoclonal antibody (one trial with 87 participants); and IL-2 RA versus polyclonal antibody (two trials with 112 participants). Thus, we were able to compare T-cell specific antibody induction versus no induction (17 trials with a total of 1955 participants). Overall, no difference in mortality (RR 0.91; 95% CI 0.64 to 1.28; low-quality of evidence), graft loss including death (RR 0.92; 95% CI 0.71 to 1.19; low-quality of evidence), and adverse events ((RR 0.97; 95% CI 0.93 to 1.02; low-quality evidence) outcomes was observed between any kind of T-cell specific antibody induction compared with no induction when the T-cell specific antibody induction agents were analysed together or separately. Acute rejection seemed to be reduced when any kind of T-cell specific antibody induction was compared with no induction (RR 0.85, 95% CI 0.75 to 0.96; moderate-quality evidence), and when trial sequential analysis was applied, the trial sequential monitoring boundary for benefit was crossed before the required information size was obtained. Furthermore, serum creatinine was statistically significantly higher when T-cell specific antibody induction was compared with no induction (MD 3.77 μmol/L, 95% CI 0.33 to 7.21; low-quality evidence), as well as when polyclonal T-cell specific antibody induction was compared with no induction, but this small difference was not clinically significant. We found no statistically significant differences for any of the remaining predefined outcomes — infection, cytomegalovirus infection, hepatitis C recurrence, malignancy, post-transplant lymphoproliferative disease, renal failure requiring dialysis, hyperlipidaemia, diabetes mellitus, and hypertension — when the T-cell specific antibody induction agents were analysed together or separately. Limited data were available for meta-analysis on drug-specific adverse events such as haematological adverse events for antithymocyte globulin. No data were found on quality of life.\nWhen T-cell specific antibody induction agents were compared with another type of antibody induction, no statistically significant differences were found for mortality, graft loss, and acute rejection for the separate analyses. When interleukin-2 receptor antagonists were compared with polyclonal T-cell specific antibody induction, drug-related adverse events were less common among participants treated with interleukin-2 receptor antagonists (RR 0.23, 95% CI 0.09 to 0.63; low-quality evidence), but this was caused by the results from one trial, and trial sequential analysis could not exclude random errors. We found no statistically significant differences for any of the remaining predefined outcomes: infection, cytomegalovirus infection, hepatitis C recurrence, malignancy, post-transplant lymphoproliferative disease, renal failure requiring dialysis, hyperlipidaemia, diabetes mellitus, and hypertension. No data were found on quality of life.\nAuthors' conclusions\nThe effects of T-cell antibody induction remain uncertain because of the high risk of bias of the randomised clinical trials, the small number of randomised clinical trials reported, and the limited numbers of participants and outcomes in the trials. T-cell specific antibody induction seems to reduce acute rejection when compared with no induction. No other clear benefits or harms were associated with the use of any kind of T-cell specific antibody induction compared with no induction, or when compared with another type of T-cell specific antibody. Hence, more randomised clinical trials are needed to assess the benefits and harms of T-cell specific antibody induction compared with placebo, and compared with another type of antibody, for prevention of rejection in liver transplant recipients. Such trials ought to be conducted with low risks of systematic error (bias) and low risk of random error (play of chance).\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": "The effects of T-cell antibody induction remain uncertain because of high risk of bias of the randomised clinical trials, the small number of randomised clinical trials reported, and the limited numbers of participants and outcomes in the trials. T-cell specific antibody induction seems to reduce acute rejection when compared with no induction. No other clear benefits or harms were associated with the use of any kind of T-cell specific antibody induction compared with no induction, or when compared with another type of T-cell specific antibody. Hence, more randomised clinical trials are needed to assess the benefits and harms of T-cell specific antibody induction compared with placebo, and compared with another type of antibody, for prevention of rejection in liver transplant recipients. Such trials ought to be conducted with low risk of systematic error (bias) and low risk of random error (play of chance)."
}
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query-laysum | 4998 | [
{
"role": "user",
"content": "Abstract: Background\nThe projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether insulin secretagogues (sulphonylureas and meglitinide analogues) are able to prevent or delay T2DM and its associated complications in people at risk for the development of T2DM is unknown.\nObjectives\nTo assess the effects of insulin secretagogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was April 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of 12 weeks or more comparing insulin secretagogues with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with impaired fasting glucose, impaired glucose tolerance, moderately elevated HbA1c or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles/records, assessed quality and extracted outcome data independently. One review author extracted data which were checked by a second review author. We resolved discrepancies by consensus or the involvement of a third review author. For meta-analyses we used a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We carried out trial sequential analyses (TSAs) for all outcomes that could be meta-analysed. We assessed the overall quality of the evidence by using the GRADE instrument.\nMain results\nWe included six RCTs with 10,018 participants; 4791 participants with data on allocation to intervention groups were randomised to a second- or third-generation sulphonylurea or a meglitinide analogue as monotherapy and 29 participants were randomised to a second-generation sulphonylurea plus metformin. Three trials investigated a second-generation sulphonylurea, two trials investigated a third-generation sulphonylurea and one trial a meglitinide analogue. A total of 4873 participants with data on allocation to control groups were randomised to a comparator group; 4820 participants were randomised to placebo, 23 to diet and exercise, and 30 participants to metformin monotherapy. One RCT of nateglinide contributed 95% of all participants. The duration of the intervention varied from six months to five years. We judged none of the included trials as at low risk of bias for all 'Risk of bias' domains.\nAll-cause and cardiovascular mortality following sulphonylurea (glimepiride) treatment were rarely observed (very low-quality evidence). The RR for incidence of T2DM comparing glimepiride monotherapy with placebo was 0.75; 95% CI 0.54 to 1.04; P = 0.08; 2 trials; 307 participants; very low-quality evidence. One of the trials reporting on the incidence of T2DM did not define the diagnostic criteria used. The other trial diagnosed T2DM as two consecutive fasting blood glucose values ≥ 6.1 mmol/L. TSA showed that only 4.5% of the diversity-adjusted required information size was accrued so far. No trial reported data on serious adverse events, non-fatal myocardial infarction (MI), non-fatal stroke, congestive heart failure (HF), health-related quality of life or socioeconomic effects.\nOne trial with a follow-up of five years compared a meglitinide analogue (nateglinide) with placebo. A total of 310/4645 (6.7%) participants allocated to nateglinide died compared with 312/4661 (6.7%) participants allocated to placebo (hazard ratio (HR) 1.00; 95% CI 0.85 to 1.17; P = 0.98; moderate-quality evidence). The two main criteria for diagnosing T2DM were a fasting plasma glucose level ≥ 7.0 mmol/L or a 2-hour post challenge glucose ≥ 11.1 mmol/L. T2DM developed in 1674/4645 (36.0%) participants in the nateglinide group and in 1580/4661 (33.9%) in the placebo group (HR 1.07; 95% CI 1.00 to 1.15; P = 0.05; moderate-quality evidence). One or more serious adverse event was reported in 2066/4602 (44.9%) participants allocated to nateglinide compared with 2089/4599 (45.6%) participants allocated to placebo. A total of 126/4645 (2.7%) participants allocated to nateglinide died because of cardiovascular disease compared with 118/4661 (2.5%) participants allocated to placebo (HR 1.07; 95% CI 0.83 to 1.38; P = 0.60; moderate-quality evidence). Comparing participants receiving nateglinide with those receiving placebo for the outcomes MI, non-fatal stroke and HF gave the following event rates: MI 116/4645 (2.5%) versus 122/4661 (2.6%), stroke 100/4645 (2.2%) versus 110/4661 (2.4%) and numbers hospitalised for HF 85/4645 (1.8%) versus 100/4661 (2.1%) - (HR 0.85; 95% CI 0.64 to 1.14; P = 0.27). The quality of the evidence was moderate for all these outcomes. Health-related quality of life or socioeconomic effects were not reported.\nAuthors' conclusions\nThere is insufficient evidence to demonstrate whether insulin secretagogues compared mainly with placebo reduce the risk of developing T2DM and its associated complications in people at increased risk for the development of T2DM. Most trials did not investigate patient-important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the medical literature and registers of ongoing trials for randomised controlled trials of at least 12 weeks' duration comparing insulin secretagogues with another glucose-lowering drug, placebo or no intervention. Randomised controlled trials are clinical studies in which people are randomly allocated to one of two or more groups so that the effects of different interventions can be compared directly. Participants included in the studies had to have glucose levels higher than considered normal, but below the glucose levels that are used to diagnose type 2 diabetes mellitus. We combined the findings of several studies to answer our review question. We found six randomised controlled trials. A total of 10,018 participants were included. The duration of the interventions varied from six months to five years.\nThis evidence is up to date as of April 2016."
}
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query-laysum | 4999 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom with cancer, and 30% to 50% of all people with cancer will experience moderate to severe pain that can have a major negative impact on their quality of life. Non-opioid drugs are commonly used to treat mild to moderate cancer pain, and are recommended for this purpose in the WHO cancer pain treatment ladder, either alone or in combination with opioids.\nA previous Cochrane review that examined the evidence for nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol, alone or combined with opioids, for cancer pain was withdrawn in 2015 because it was out of date; the date of the last search was 2005. This review, and another on NSAIDs, updates the evidence.\nObjectives\nTo assess the efficacy of oral paracetamol (acetaminophen) for cancer pain in adults and children, and the adverse events reported during its use in clinical trials.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to March 2017, together with reference lists of retrieved papers and reviews, and two online study registries.\nSelection criteria\nWe included randomised, double-blind, studies of five days' duration or longer, comparing paracetamol alone with placebo, or paracetamol in combination with an opioid compared with the same dose of the opioid alone, for cancer pain of any intensity. Single-blind and open studies were also eligible for inclusion. The minimum study size was 25 participants per treatment arm at the initial randomisation.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nThree studies in adults satisfied the inclusion criteria, lasting up to one week; 122 participants were randomised initially, and 95 completed treatment. We found no studies in children. One study was parallel-group, and two had a cross-over design. All used paracetamol as an add-on to established treatment with strong opioids (median daily morphine equivalent doses of 60 mg, 70 mg, and 225 mg, with some participants taking several hundred mg of oral morphine equivalents daily). Other non-paracetamol medication included non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic antidepressants, or neuroleptics. All studies were at high risk of bias for incomplete outcome data and small size; none was unequivocally at low risk of bias.\nNone of the studies reported any of our primary outcomes: participants with pain reduction of at least 50%, and at least 30%, from baseline; participants with pain no worse than mild at the end of the treatment period; participants with Patient Global Impression of Change (PGIC) of much improved or very much improved (or equivalent wording). What pain reports there were indicated no difference between paracetamol and placebo when added to another treatment. There was no convincing evidence of paracetamol being different from placebo with regards to quality of life, use of rescue medication, or participant satisfaction or preference. Measures of harm (serious adverse events, other adverse events, and withdrawal due to lack of efficacy) were inconsistently reported and provided no clear evidence of difference.\nOur GRADE assessment of evidence quality was very low for all outcomes, because studies were at high risk of bias from several sources.\nAuthors' conclusions\nThere is no high-quality evidence to support or refute the use of paracetamol alone or in combination with opioids for the first two steps of the three-step WHO cancer pain ladder. It is not clear whether any additional analgesic benefit of paracetamol could be detected in the available studies, in view of the doses of opioids used.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found no evidence that taking paracetamol alone made any difference to the level of pain experienced. We found no evidence that taking paracetamol together with a morphine-like drug was better than the morphine-like drug alone. Paracetamol did not appear to improve quality of life. No conclusions could be reached about side effects. The amount of information and the differences in how studies were reported meant that no conclusions could be made."
}
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query-laysum | 5000 | [
{
"role": "user",
"content": "Abstract: Background\nProlonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions.\nObjectives\n1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;\n2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;\n3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used.\nSearch methods\nWe used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of the trials included in the effectiveness reviews as well as of studies (potentially) included in the qualitative synthesis, conducted citation searches of the publications reporting these studies, and contacted content experts.\nWe reran the search on 3rd July 2016 and found three studies, which are awaiting classification.\nSelection criteria\nWe included qualitative studies that described: the circumstances in which protocols are designed, implemented or used, or both, and the views and experiences of healthcare professionals either involved in the design, implementation or use of weaning protocols or involved in the weaning of critically-ill adults and children from mechanical ventilation not using protocols. We included studies that: reflected on any aspect of the use of protocols, explored contextual factors relevant to the development, implementation or use of weaning protocols, and reported contextual phenomena and outcomes identified as relevant to the effectiveness of protocolized weaning from mechanical ventilation.\nData collection and analysis\nAt each stage, two review authors undertook designated tasks, with the results shared amongst the wider team for discussion and final development. We independently reviewed all retrieved titles, abstracts and full papers for inclusion, and independently extracted selected data from included studies. We used the findings of the included studies to develop a new set of analytic themes focused on the barriers and facilitators to the use of protocols, and further refined them to produce a set of summary statements. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to arrive at a final assessment of the overall confidence of the evidence used in the synthesis. We included all studies but undertook two sensitivity analyses to determine how the removal of certain bodies of evidence impacted on the content and confidence of the synthesis. We deployed a logic model to integrate the findings of the qualitative evidence synthesis with those of the Cochrane effectiveness reviews.\nMain results\nWe included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review.\nThe quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as ‘low’, 13 as ‘moderate’ and five as ‘high’ confidence. Our synthesis produced nine analytical themes, which report potential barriers and facilitators to the use of protocols. The themes are: the need for continual staff training and development; clinical experience as this promotes felt and perceived competence and confidence to wean; the vulnerability of weaning to disparate interprofessional working; an understanding of protocols as militating against a necessary proactivity in clinical practice; perceived nursing scope of practice and professional risk; ICU structure and processes of care; the ability of protocols to act as a prompt for shared care and consistency in weaning practice; maximizing the use of protocols through visibility and ease of implementation; and the ability of protocols to act as a framework for communication with parents.\nAuthors' conclusions\nThere is a clear need for weaning protocols to take account of the social and cultural environment in which they are to be implemented. Irrespective of its inherent strengths, a protocol will not be used if it does not accommodate these complexities. In terms of protocol development, comprehensive interprofessional input will help to ensure broad-based understanding and a sense of ‘ownership’. In terms of implementation, all relevant ICU staff will benefit from general weaning as well as protocol-specific training; not only will this help secure a relevant clinical knowledge base and operational understanding, but will also demonstrate to others that this knowledge and understanding is in place. In order to maximize relevance and acceptability, protocols should be designed with the patient profile and requirements of the target ICU in mind. Predictably, an under-resourced ICU will impact adversely on protocol implementation, as staff will prioritize management of acutely deteriorating and critically-ill patients.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our synthesis included 11 studies, involving around 267 participants; five more studies are awaiting classification. We identified several potential barriers and facilitators to the use of protocols. First, doctors used protocols only in certain circumstances; otherwise they preferred to wean using their own knowledge and skills. Relatively inexperienced nurses often lacked confidence. A protocol could encourage their involvement in weaning because it set out clear instructions and also helped them to feel more secure. Although more experienced nurses also recognized these positive qualities, they criticized protocols as sometimes instructing them to wean contrary to their own clinical judgement. Second, the practical arrangements for care within an ICU could either help or hinder healthcare professionals to work together, and in this way influence how (well) a protocol was used. Third, the use of a protocol reflected how healthcare professionals interact with one another generally. For example, the degree of experience a nurse or doctor possessed could influence the confidence others had that they could wean safely. For this reason, doctors tended to be reluctant to involve nurses they considered to be relatively inexperienced in weaning, even when there was a protocol in place. Furthermore, the fact that doctors occupied a higher professional status or position meant that it was difficult for nurses to be involved in weaning, including by using a protocol, unless the doctors s/he worked with permitted this to happen."
}
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query-laysum | 5001 | [
{
"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: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence in this review is current to 23 May 2023."
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query-laysum | 5002 | [
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"role": "user",
"content": "Abstract: Background\nVitamin D is a micronutrient important for bone growth and immune function. Deficiency can lead to rickets and has been linked to various infections, including respiratory infections. The evidence on the effects of supplementation on infections in children has not been assessed systematically.\nObjectives\nTo evaluate the role of vitamin D supplementation in preventing pneumonia, tuberculosis (TB), diarrhoea, and malaria in children under five years of age. This includes high-, middle-, and low-income countries.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library, MEDLINE, EMBASE, LILACS, the WHO International Clinical Trials Registry Platform (ICTRP; http://www.who.int/ictrp/en/) , ClinicalTrials.gov and the ISRCTN registry (http://www.isrctn.com/) up to 16 June 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated preventive supplementation of vitamin D (versus placebo or no intervention) in children under five years of age.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts, extracted the data, and assessed the risk of bias of included trials.\nMain results\nFour trials met the inclusion criteria, with a total of 3198 children under five years of age, and were conducted in Afghanistan, Spain, and the USA. Prevalence of vitamin D deficiency varied widely in these populations (range: 73.1% in Afghanistan, 10 to 12% in USA, and 6.2% in Spain). The included trials evaluated mortality (two trials), pneumonia incidence (two trials), diarrhoea incidence (two trials), hospitalization (two trials), and mean serum vitamin D concentrations (four trials).\nWe do not know whether vitamin D supplementation impacts on all-cause mortality because this outcome was underpowered due to few events (risk ratio (RR) 1.43, 95% confidence interval (CI) 0.54 to 3.74; one trial, 3046 participants, low quality evidence).\nFor pneumonia, episodes of 'radiologically confirmed' first or only episode of pneumonia were little different in the supplemented and unsupplemented group (Rate Ratio: 1.06, 95% confidence interval (CI) 0.89 to 1.26; two trials, 3134 participants, moderate quality evidence), and similarly for children with confirmed or unconfirmed pneumonia (RR 0.95, 95% CI 0.87 to 1.04; one trial, 3046 participants). In these two trials there were no obvious differences between supplemented and unsupplemented children regarding episodes of diarrhoea.\nIn the single large trial from Afghanistan, the trial authors reported that vitamin D supplementation was associated with an increase in repeat episodes of pneumonia confirmed by chest radiograph (RR 1.69, 95% CI 1.28 to 2.21; one trial, 3046 participants), but not reflected in the outcome of confirmed or unconfirmed pneumonia (RR 1.06, 95% CI 1.00 to 1.13; one trial, 3046 participants).\nFor hospital admission measured in one small trial, there was no difference detected (RR 0.86, 95% CI 0.20 to 3.62; one trial, 88 participants; very low quality evidence).\nThe mean serum vitamin D concentrations were higher in supplemented compared to unsupplemented children at the end of supplementation (MD 7.72 ng/mL, 95% CI 0.50 to 14.93; four trials, 266 participants, low quality evidence). These results were driven primarily by two smaller trials with large magnitudes of effect. In the other two bigger trials, serum vitamin D concentrations were elevated in the intervention group for most of the trial duration but not at the end of supplementation. This may be due to time elapsed at measurement from the last dose, incomplete compliance, or increased need of vitamin D with infant age.\nWe did not find any trial that reported on the incidence of TB, malaria or febrile illness, duration of pneumonia, duration of diarrhoea, severity of infection, and cause-specific mortality (due to TB, diarrhoea, or malaria).\nAuthors' conclusions\nEvidence from one large trial did not demonstrate benefit of vitamin D supplementation on the incidence of pneumonia or diarrhoea in children under five years. To our knowledge, trials that evaluated supplementation for preventing other infections, including TB and malaria, have not been performed.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "One large trial has not demonstrated an effect of vitamin D on death or respiratory infections in children under five years of age. We did not find trials evaluating Vitamin D supplementation to prevent other infections such as TB and malaria."
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query-laysum | 5003 | [
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"role": "user",
"content": "Abstract: Background\nNeonates are an extremely vulnerable patient population, with 6% to 9% admitted to the neonatal intensive care unit (NICU) following birth. Neonates admitted to the NICU will undergo multiple painful procedures per day throughout their stay. There is increasing evidence that frequent and repetitive exposure to painful stimuli is associated with poorer outcomes later in life.\nTo date, a wide variety of pain control mechanisms have been developed and implemented to address procedural pain in neonates. This review focused on non-opioid analgesics, specifically non-steroidal anti-inflammatory drugs (NSAIDs) and N-methyl-D-aspartate (NMDA) receptor antagonists, which alleviate pain through inhibiting cellular pathways to achieve analgesia.\nThe analgesics considered in this review show potential for pain relief in clinical practice; however, an evidence summation compiling the individual drugs they comprise and outlining the benefits and harms of their administration is lacking. We therefore sought to summarize the evidence on the level of pain experienced by neonates both during and following procedures; relevant drug-related adverse events, namely episodes of apnea, desaturation, bradycardia, and hypotension; and the effects of combinations of drugs.\nAs the field of neonatal procedural pain management is constantly evolving, this review aimed to ascertain the scope of non-opioid analgesics for neonatal procedural pain to provide an overview of the options available to better inform evidence-based clinical practice.\nObjectives\nTo determine the effects of non-opioid analgesics in neonates (term or preterm) exposed to procedural pain compared to placebo or no drug, non-pharmacological intervention, other analgesics, or different routes of administration.\nSearch methods\nWe searched the Cochrane Library (CENTRAL), PubMed, Embase, and two trial registries in June 2022. We screened the reference lists of included studies for studies not identified by the database searches.\nSelection criteria\nWe included all randomized controlled trials (RCTs), quasi-RCTs, and cluster-RCTs in neonates (term or preterm) undergoing painful procedures comparing NSAIDs and NMDA receptor antagonists to placebo or no drug, non-pharmacological intervention, other analgesics, or different routes of administration.\nData collection and analysis\nWe used standard Cochrane methods. Our main outcomes were pain assessed during the procedure and up to 10 minutes after the procedure with a validated scale; episodes of bradycardia; episodes of apnea; and hypotension requiring medical therapy.\nMain results\nWe included two RCTs involving a total of 269 neonates conducted in Nigeria and India.\nNMDA receptor antagonists versus no treatment, placebo, oral sweet solution, or non-pharmacological intervention\nOne RCT evaluated using oral ketamine (10 mg/kg body weight) versus sugar syrup (66.7% w/w at 1 mL/kg body weight) for neonatal circumcision.\nThe evidence is very uncertain about the effect of ketamine on pain score during the procedure, assessed with the Neonatal Infant Pain Scale (NIPS), compared with placebo (mean difference (MD) −0.95, 95% confidence interval (CI) −1.32 to −0.58; 1 RCT; 145 participants; very low-certainty evidence). No other outcomes of interest were reported on.\nHead-to-head comparison of different analgesics\nOne RCT evaluated using intravenous fentanyl versus intravenous ketamine during laser photocoagulation for retinopathy of prematurity. Neonates receiving ketamine followed an initial regimen (0.5 mg/kg bolus 1 minute before procedure) or a revised regimen (additional intermittent bolus doses of 0.5 mg/kg every 10 minutes up to a maximum of 2 mg/kg), while those receiving fentanyl followed either an initial regimen (2 μg/kg over 5 minutes, 15 minutes before the procedure, followed by 1 μg/kg/hour as a continuous infusion) or a revised regimen (titration of 0.5 μg/kg/hour every 15 minutes to a maximum of 3 μg/kg/hour). The evidence is very uncertain about the effect of ketamine compared with fentanyl on pain score assessed with the Premature Infant Pain Profile-Revised (PIPP-R) scores during the procedure (MD 0.98, 95% CI 0.75 to 1.20; 1 RCT; 124 participants; very low-certainty evidence); on episodes of apnea occurring during the procedure (risk ratio (RR) 0.31, 95% CI 0.08 to 1.18; risk difference (RD) −0.09, 95% CI −0.19 to 0.00; 1 study; 124 infants; very low-certainty evidence); and on hypotension requiring medical therapy occurring during the procedure (RR 5.53, 95% CI 0.27 to 112.30; RD 0.03, 95% CI −0.03 to 0.10; 1 study; 124 infants; very low-certainty evidence). The included study did not report pain score assessed up to 10 minutes after the procedure or episodes of bradycardia occurring during the procedure.\nWe did not identify any studies comparing NSAIDs versus no treatment, placebo, oral sweet solution, or non-pharmacological intervention or different routes of administration of the same analgesics. We identified three studies awaiting classification.\nAuthors' conclusions\nThe two small included studies comparing ketamine versus either placebo or fentanyl, with very low-certainty evidence, rendered us unable to draw meaningful conclusions. The evidence is very uncertain about the effect of ketamine on pain score during the procedure compared with placebo or fentanyl. We found no evidence on NSAIDs or studies comparing different routes of administration.\nFuture research should prioritize large studies evaluating non-opioid analgesics in this population. As the studies included in this review suggest potential positive effects of ketamine administration, studies evaluating ketamine are of interest. Furthermore, as we identified no studies on NSAIDs, which are widely used in older infants, or comparing different routes of administration, such studies should be a priority going forward.\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": "Babies, particularly those born too early or sickest, may undergo many painful procedures during their hospital stay. It is still unclear which painkillers are best for adequate and safe pain relief. We specifically focused on studies evaluating non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, and N-methyl-D-aspartate (NMDA) receptor antagonists, such as ketamine, for babies during painful procedures. We wanted to find out how they affected pain intensity in babies during the procedures and any side effects the painkillers caused."
}
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query-laysum | 5004 | [
{
"role": "user",
"content": "Abstract: Background\nShivering after general anaesthesia is common. It is unpleasant but can also have adverse physiological effects. Alpha-2 (α-2) adrenergic agonist receptors, which can lead to reduced sympathetic activity and central regulation of vasoconstrictor tone, are a group of drugs that have been used to try to prevent postoperative shivering.\nObjectives\nTo assess the following: the effects of α-2 agonists on the prevention of shivering and subsequent complications after general anaesthesia in people undergoing surgery; the effects of α-2 agonists on the risk of inadvertent perioperative hypothermia; and whether any adverse effects are associated with these interventions.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE on 13 June 2014. Our search terms were relevant to the review question and limited to studies that assessed shivering or hypothermia. We also carried out searches of clinical trials registers, and forward and backward citation tracking.\nSelection criteria\nWe considered all randomized controlled trials, quasi-randomized studies, and cluster-randomized studies with adult participants undergoing surgery with general anaesthesia in which an α-2 agonist was compared with another α-2 agonist or a placebo for the prevention of shivering.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data, consulting a third review author in the case of disagreements. We used standard Cochrane methodological procedures, including an assessment of risk of bias and use of GRADEpro software to interpret findings.\nMain results\nWe included 20 studies with 1401 surgical participants comparing an α-2 agonist against a control. Thirteen studies compared clonidine with a control, whilst seven compared dexmedetomidine with a control. The doses, methods, and time of administration varied between studies: three studies gave the drug orally or as an intravenous bolus preoperatively and nine intraoperatively; one study gave the drug as an infusion starting preoperatively and seven started at varying points from anaesthetic induction to the end of surgery. Whilst all the studies were described as randomized, many provided insufficient detail on methods used. We had anticipated that attempts would be made to reduce performance bias by blinding of personnel and participants, however this was detailed in only six of the papers. Similarly, in some studies detail was lacking on methods to reduce the risk of detection bias. We therefore downgraded the quality of evidence in our 'Summary of findings' table by one level for risk of bias using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.\nAll 20 included studies presented outcome data for postoperative shivering, and in meta-analysis α-2 agonists were shown to significantly reduce the risk of shivering (Mantel-Haenszel risk ratio 0.28, 95% confidence interval 0.18 to 0.43, P value < 0.0001). We found significant evidence of heterogeneity (I2 = 80%) for this result that was not explained by sensitivity or subgroup analysis; we therefore downgraded the inconsistency of the evidence by one level. Although we did not feel that there were concerns with imprecision or indirectness of the data, we downgraded the quality of the evidence for the risk of publication bias following visual analysis of a funnel plot. Using GRADEpro, we rated the overall quality of the data for shivering as very low. Only one study reported the incidence of core hypothermia, whilst 12 studies measured core temperature. However, as the results for core temperature were reported in different styles, pooling the results was inappropriate. We found no studies with participant-reported outcomes such as experience of shivering or participant satisfaction. We found limited data for the outcomes of length of stay in the postanaesthetic care unit (three studies, 200 participants) and the following adverse effects: sedation (nine studies, 875 participants), bradycardia (eight studies, 716 participants), and hypotension (seven studies, 688 participants). Unpooled analysis suggested that sedation and bradycardia were significantly more common with dexmedetomidine than placebo, with all seven dexmedetomidine studies and none of the clonidine studies reporting statistically significantly higher levels of sedation as an adverse effect.\nAuthors' conclusions\nThere is evidence that clonidine and dexmedetomidine can reduce postoperative shivering, but patients given dexmedetomidine may be more sedated. However, our assessment of the quality of this evidence is very low.\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": "All studies reported results for shivering. Our analysis showed that α-2 agonists significantly reduce the risk of postoperative shivering when administered before or during surgery. However, our analysis also showed that there were significant differences between studies that we could not explain. Some study authors had also presented results for core temperature, length of stay in the recovery room, and clinical side effects of the drugs. Seven studies reported that participants given dexmedetomidine were more likely to have a higher level of sedation after surgery, and five studies reported that participants given dexmedetomidine were more likely to have bradycardia (slower heart rate). We did not combine these results in an analysis. None of the studies presented patient-reported outcomes."
}
]
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query-laysum | 5005 | [
{
"role": "user",
"content": "Abstract: Background\nAnorexia nervosa is a psychological condition characterised by self-starvation and fear or wait gain or other body image disturbance. The first line of treatment is specific psychological therapy; however, there is no consensus on best practice for treating people who develop severe and enduring anorexia nervosa (SEAN). Notably, there is no universal definition of SEAN.\nObjectives\nTo evaluate the benefits and harms of specific psychological therapies for severe and enduring anorexia nervosa compared with other specific therapies, non-specific therapies, no treatment/waiting list, antidepressant medication, dietary counselling alone, or treatment as usual.\nSearch methods\nWe used standard, extensive Cochrane search methods. The last search date was 22 July 2022.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs) of people (any age) with anorexia nervosa of at least three years' duration. Eligible experimental interventions were any specific psychological therapy for improved physical and psychological health in anorexia nervosa, conducted in any treatment setting with no restrictions in terms of number of sessions, modality, or duration of therapy. Eligible comparator interventions included any other specific psychological therapy for anorexia nervosa, non-specific psychological therapy for mental health disorders, no treatment or waiting list, antipsychotic treatment (with or without psychological therapy), antidepressant treatment (with or without psychological therapy), dietary counselling, and treatment as usual as defined by the individual trials.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were clinical improvement (weight restoration to within the normal weight range for participant sample) and treatment non-completion. Results were presented using the GRADE appraisal tool.\nMain results\nWe found two eligible studies, but only one study provided usable data. This was a parallel-group RCT of 63 adults with SEAN who had an illness duration of at least seven years. The trial compared outpatient cognitive behaviour therapy for SEAN (CBT-SEAN) with specialist supportive clinical management for SEAN (SSCM-SE) over eight months. It is unclear if there is any difference between the effect of CBT-SEAN versus SSCM-SE on clinical improvement at 12 months (risk ratio (RR) 1.42, 95% confidence interval (CI) 0.66 to 3.05) or treatment non-completion (RR 1.72, 95% CI 0.45 to 6.59). There were no reported data on adverse effects. The trial was at high risk of performance and detection bias.\nWe rated the GRADE level of evidence as very low-certainty for both primary outcomes, downgrading for imprecision and risk of bias concerns.\nAuthors' conclusions\nThis review reports evidence from one trial that evaluated CBT-SEAN versus SSCM-SE. There was very low-certainty evidence of little or no difference in clinical improvement and treatment non-completion between the two therapies. There is a need for larger high-quality trials to determine the benefits of specific psychological therapies for people with SEAN. These should take into account the duration of illness as well as participants' previous experience with evidence-based psychological therapy for anorexia nervosa.\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": "1. One small study of people with severe and enduring anorexia nervosa compared two therapies: cognitive behaviour therapy and specialist supportive clinical management.\n2. There is not enough evidence to say with certainty if any specific therapy is more effective than any other.\n3. There is a need for larger studies to investigate the benefits of treatment for people with SEAN."
}
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query-laysum | 5006 | [
{
"role": "user",
"content": "Abstract: Background\nUltrasound examination of pregnancy before 24 weeks gestation may lead to more accurate dating and earlier diagnosis of pathology, but may also give false reassurance. It can be used to monitor development or diagnose conditions of an unborn baby. This review compares the effect of routine or universal, ultrasound examination, performed before 24 completed weeks' gestation, with selective or no ultrasound examination.\nObjectives\nTo assess the effect of routine pregnancy ultrasound before 24 weeks as part of a screening programme, compared to selective ultrasound or no ultrasound, on the early diagnosis of abnormal pregnancy location, termination for fetal congenital abnormality, multiple pregnancy, maternal outcomes and later fetal compromise.\nTo assess the effect of first trimester (before 14 weeks) and second trimester (14 to 24 weeks) ultrasound, separately.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, and the World Health Organization's International Clinical Trials Registry Platform (ICTRP) on 11 August 2020. We also examined the reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and RCTs published in abstract form. We included all trials with pregnant women who had routine or revealed ultrasound versus selective ultrasound, no ultrasound, or concealed ultrasound, before 24 weeks' gestation. All eligible studies were screened for scientific integrity and trustworthiness.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and risk of bias, extracted data and checked extracted data for accuracy. Two review authors independently used the GRADE approach to assess the certainty of evidence for each outcome\nMain results\nOur review included data from 13 RCTs including 85,265 women. The review included four comparisons. Four trials were assessed to be at low risk of bias for both sequence generation and allocation concealment and two as high risk. The nature of the intervention made it impossible to blind women and staff providing care to treatment allocation. Sample attrition was low in the majority of trials and outcome data were available for most women. Many trials were conducted before it was customary for trials to be registered and protocols published.\nFirst trimester routine versus selective ultrasound: four studies, 1791 women, from Australia, Canada, the United Kingdom (UK) and the United States (US).\nFirst trimester scans probably reduce short-term maternal anxiety about pregnancy (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.65 to 0.99; moderate-certainty evidence). We do not have information on whether the reduction was sustained.\nThe evidence is very uncertain about the effect of first trimester scans on perinatal loss (RR 0.97, 95% CI 0.55 to 1.73; 648 participants; one study; low-certainty evidence) or induction of labour for post-maturity (RR 0.83, 95% CI 0.50 to 1.37; 1474 participants; three studies; low-certainty evidence).\nThe effect of routine first trimester ultrasound on birth before 34 weeks or termination of pregnancy for fetal abnormality was not reported.\nSecond trimester routine versus selective ultrasound: seven studies, 36,053 women, from Finland, Norway, South Africa, Sweden and the US.\nSecond trimester scans probably make little difference to perinatal loss (RR 0.98, 95% CI 0.81 to 1.20; 17,918 participants, three studies; moderate-certainty evidence) or intrauterine fetal death (RR 0.97, 95% CI 0.66 to 1.42; 29,584 participants, three studies; low-certainty evidence).\nSecond trimester scans may reduce induction of labour for post-maturity (RR 0.48, 95% CI 0.31 to 0.73; 24,174 participants, six studies; low-certainty evidence), presumably by more accurate dating.\nRoutine second trimester ultrasound may improve detection of multiple pregnancy (RR 0.05, 95% CI 0.02 to 0.16; 274 participants, five studies; low-certainty evidence).\nRoutine second trimester ultrasound may increase detection of major fetal abnormality before 24 weeks (RR 3.45, 95% CI 1.67 to 7.12; 387 participants, two studies; low-certainty evidence) and probably increases the number of women terminating pregnancy for major anomaly (RR 2.36, 95% CI 1.13 to 4.93; 26,893 participants, four studies; moderate-certainty evidence).\nLong-term follow-up of children exposed to scans before birth did not indicate harm to children's physical or intellectual development (RR 0.77, 95% CI 0.44 to 1.34; 603 participants, one study; low-certainty evidence).\nThe effect of routine second trimester ultrasound on birth before 34 weeks or maternal anxiety was not reported.\nStandard care plus two ultrasounds and referral for complications versus standard care: one cluster-RCT, 47,431 women, from Democratic Republic of Congo, Guatemala, Kenya, Pakistan and Zambia.\nThis trial included a co-intervention, training of healthcare workers and referral for complications and was, therefore, assessed separately.\nStandard pregnancy care plus two scans, and training and referral for complications, versus standard care probably makes little difference to whether women with complications give birth in a risk appropriate setting with facilities for caesarean section (RR 1.03, 95% CI 0.89 to 1.19; 11,680 participants; moderate-certainty evidence). The intervention also probably makes little to no difference to low birthweight (< 2500 g) (RR 1.01, 95% CI 0.90 to 1.13; 47,312 participants; moderate-certainty evidence). The evidence is very uncertain about whether the community intervention (including ultrasound) makes any difference to maternal mortality (RR 0.92, 95% CI 0.55 to 1.55; 46,768 participants; low-certainty evidence).\nRevealed ultrasound results (communicated to both patient and doctor) versus concealed ultrasound results (blinded to both patient and doctor at any time before 24 weeks): one study, 1095 women, from the UK.\nThe evidence was very uncertain for all results relating to revealed versus concealed ultrasound scan (very low-certainty evidence).\nAuthors' conclusions\nEarly scans probably reduce short term maternal anxiety.\nLater scans may reduce labour induction for post-maturity. They may improve detection of major fetal abnormalities and increase the number of women who choose termination of pregnancy for this reason. They may also reduce the number of undetected twin pregnancies. All these findings accord with observational data.\nNeither type of scan appears to alter other important maternal or fetal outcomes, but our review may underestimate the effect in modern practice because trials were mostly from relatively early in the development of the technology, and many control participants also had scans. The trials were also underpowered to show an effect on other important maternal or fetal outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Routine later scanning\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Second trimester scans, at 14 to 24 weeks, increased detection of baby abnormalities, and more women chose termination of pregnancy for this reason. There was no evidence of an effect on perinatal loss. Induction of labour to prevent the pregnancy going overdue was reduced. No studies reported how it affected maternal anxiety. Multiple pregnancies were more likely to be detected by 24 weeks. Long-term follow-up of children exposed to these scans did not indicate that they were harmful to children's physical or intellectual development.\nWe also found one trial from a group of low and middle income countries, comparing a combination of two scans and specialist training of health professionals and referral of women with complications, with selective scans and routine care. The intervention did not alter the number of women delivering in a hospital with caesarean section facility. Nor did it appear to reduce maternal deaths or the numbers of low-birthweight babies, although the evidence was very uncertain.\nWe also found one trial where all women underwent scans but the results were revealed to the health care professionals in half the cases. This trial showed no important effect of revealing the scan results but the evidence was very uncertain.\nMost studies were carried out relatively early in the development of scan technology and when training in its use was less advanced. In most trials a large proportion of women in the control groups received a scan too."
}
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query-laysum | 5007 | [
{
"role": "user",
"content": "Abstract: Background\nTraditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income countries due to its effectiveness and relatively low cost. However, there are concerns over the use of amalgam restorations (fillings) with regard to mercury release in the body and the environmental impact of mercury disposal. Dental composite resin materials are an aesthetic alternative to amalgam, and their mechanical properties have developed sufficiently to make them suitable for restoring posterior teeth. Nevertheless, composite resin materials may have potential for toxicity to human health and the environment.\nThe United Nations Environment Programme has established the Minamata Convention on Mercury, which is an international treaty that aims \"to protect the [sic] human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds\". It entered into force in August 2017, and as of February 2021 had been ratified by 127 governments. Ratification involves committing to the adoption of at least two of nine proposed measures to phase down the use of mercury, including amalgam in dentistry. In light of this, we have updated a review originally published in 2014, expanding the scope of the review by undertaking an additional search for harms outcomes. Our review synthesises the results of studies that evaluate the long-term effectiveness and safety of amalgam versus composite resin restorations, and evaluates the level of certainty we can have in that evidence.\nObjectives\nTo examine the effects (i.e. efficacy and safety) of direct composite resin fillings versus amalgam fillings.\nSearch methods\nAn information specialist searched five bibliographic databases up to 16 February 2021 and used additional search methods to identify published, unpublished and ongoing studies\nSelection criteria\nTo assess efficacy, we included randomised controlled trials (RCTs) comparing dental composite resin with amalgam restorations in permanent posterior teeth that assessed restoration failure or survival at follow-up of at least three years.\nTo assess safety, we sought non-randomised studies in addition to RCTs that directly compared composite resin and amalgam restorative materials and measured toxicity, sensitivity, allergy, or injury.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included a total of eight studies in this updated review, all of which were RCTs. Two studies used a parallel-group design, and six used a split-mouth design. We judged all of the included studies to be at high risk of bias due to lack of blinding and issues related to unit of analysis. We identified one new trial since the previous version of this review (2014), as well as eight additional papers that assessed safety, all of which related to the two parallel-group studies that were already included in the review.\nFor our primary meta-analyses, we combined data from the two parallel-group trials, which involved 1645 composite restorations and 1365 amalgam restorations in 921 children. We found low-certainty evidence that composite resin restorations had almost double the risk of failure compared to amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35; P < 0.001), and were at much higher risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74; P < 0.001). We found low-certainty evidence that composite resin restorations were not more likely to result in restoration fracture (RR 0.87, 95% CI 0.46 to 1.64; P = 0.66).\nSix trials used a split-mouth design. We considered these studies separately, as their reliability was compromised due to poor reporting, unit of analysis errors, and variability in methods and findings. Subgroup analysis showed that the findings were consistent with the results of the parallel-group studies.\nThree trials investigated possible harms of dental restorations. Higher urinary mercury levels were reported amongst children with amalgam restorations in two trials, but the levels were lower than what is known to be toxic. Some differences between amalgam and composite resin groups were observed on certain measures of renal, neuropsychological, and psychosocial function, physical development, and postoperative sensitivity; however, no consistent or clinically important harms were found. We considered that the vast number of comparisons made false-positive results likely. There was no evidence of differences between the amalgam and composite resin groups in neurological symptoms, immune function, and urinary porphyrin excretion. The evidence is of very low certainty, with most harms outcomes reported in only one trial.\nAuthors' conclusions\nLow-certainty evidence suggests that composite resin restorations may have almost double the failure rate of amalgam restorations. The risk of restoration fracture does not seem to be higher with composite resin restorations, but there is a much higher risk of developing secondary caries. Very low-certainty evidence suggests that there may be no clinically important differences in the safety profile of amalgam compared with composite resin dental restorations.\nThis review supports the utility of amalgam restorations, and the results may be particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Of note, however, is that composite resin materials have undergone important improvements in the years since the trials informing the primary analyses for this review were conducted. The global phase-down of dental amalgam via the Minamata Convention on Mercury is an important consideration when deciding between amalgam and composite resin dental materials. The choice of which dental material to use will depend on shared decision-making between dental providers and patients in the clinic setting, and local directives and protocols.\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 scientific databases until 16 February 2021 and found eight relevant studies. The studies evaluated 3285 composite fillings and 1955 amalgam fillings; however, it is unclear how many participants received these fillings. The exact age of participants was unclear in some studies, but the studies included both children and adults. The studies took place in the UK, the USA, Portugal, Sweden, the Netherlands, Belgium, Germany, and Turkey.\nParticipants in six studies received composite and amalgam fillings in different teeth (known as 'split-mouth design'), whilst participants in the other two studies received either composite or amalgam fillings ('parallel-group' design)."
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query-laysum | 5008 | [
{
"role": "user",
"content": "Abstract: Background\nMechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.\nObjectives\nTo determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.\nSelection criteria\nClinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.\nMechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI).\nThis review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.\nMain results\nThis review includes a total of 112 trials, with 104 studies contributing data (22,055 women; 21 comparisons). Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.\nBalloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively.\nBalloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence.\nBalloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence.\nAuthors' conclusions\nLow- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted.\nModerate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile.\nFuture research could be focused more on safety aspects for the neonate and maternal satisfaction.\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": "More and more women have labour induced and indications are often not urgent. This means that the safety aspects of induction methods become more important, although this could be at the expense of effectiveness. Mechanical methods could have advantages over pharmacological methods as they are widely available, low in cost and may have fewer side effects, such as excessive contractions of the uterus (uterine hyperstimulation). This could potentially be safer for the baby because if contractions are too long or very close together, the baby may not receive sufficient oxygen."
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query-laysum | 5009 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 30% of hospitalised older adults experience hospital-associated functional decline. Exercise interventions that promote in-hospital activity may prevent deconditioning and thereby maintain physical function during hospitalisation. This is an update of a Cochrane Review first published in 2007.\nObjectives\nTo evaluate the benefits and harms of exercise interventions for acutely hospitalised older medical inpatients on functional ability, quality of life (QoL), participant global assessment of success and adverse events compared to usual care or a sham-control intervention.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was May 2021.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials evaluating an in-hospital exercise intervention in people aged 65 years or older admitted to hospital with a general medical condition. We excluded people admitted for elective reasons or surgery.\nData collection and analysis\nWe used standard Cochrane methods. Our major outcomes were 1. independence with activities of daily living; 2. functional mobility; 3. new incidence of delirium during hospitalisation; 4. QoL; 5. number of falls during hospitalisation; 6. medical deterioration during hospitalisation and 7. participant global assessment of success. Our minor outcomes were 8. death during hospitalisation; 9. musculoskeletal injuries during hospitalisation; 10. hospital length of stay; 11. new institutionalisation at hospital discharge; 12. hospital readmission and 13. walking performance. We used GRADE to assess certainty of evidence for each major outcome.\nWe categorised exercise interventions as: rehabilitation-related activities (interventions designed to increase physical activity or functional recovery, but did not follow a specified exercise protocol); structured exercise (interventions that included an exercise intervention protocol but did not include progressive resistance training); and progressive resistance exercise (interventions that included an element of progressive resistance training).\nMain results\nWe included 24 studies (nine rehabilitation-related activity interventions, six structured exercise interventions and nine progressive resistance exercise interventions) with 7511 participants. All studies compared exercise interventions to usual care; two studies, in addition to usual care, used sham interventions. Mean ages ranged from 73 to 88 years, and 58% of participants were women.\nSeveral studies were at high risk of bias. The most common domain assessed at high risk of bias was measurement of the outcome, and five studies (21%) were at high risk of bias arising from the randomisation process.\nExercise may have no clinically important effect on independence in activities of daily living at discharge from hospital compared to controls (16 studies, 5174 participants; low-certainty evidence). Five studies used the Barthel Index (scale: 0 to 100, higher scores representing greater independence). Mean scores at discharge in the control groups ranged from 42 to 96 points, and independence in activities of daily living was 1.8 points better (0.43 worse to 4.12 better) with exercise compared to controls. The minimally clinical important difference (MCID) is estimated to be 11 points.\nWe are uncertain regarding the effect of exercise on functional mobility at discharge from the hospital compared to controls (8 studies, 2369 participants; very low-certainty evidence). Three studies used the Short Physical Performance Battery (SPPB) (scale: 0 to 12, higher scores representing better function) to measure functional mobility. Mean scores at discharge in the control groups ranged from 3.7 to 4.9 points on the SPPB, and the estimated effect of the exercise interventions was 0.78 points better (0.02 worse to 1.57 better). A change of 1 point on the SPPB represents an MCID.\nWe are uncertain regarding the effect of exercise on the incidence of delirium during hospitalisation compared to controls (7 trials, 2088 participants; very low-certainty evidence). The incidence of delirium during hospitalisation was 88/1091 (81 per 1000) in the control group compared with 70/997 (73 per 1000; range 47 to 114) in the exercise group (RR 0.90, 95% CI 0.58 to 1.41).\nExercise interventions may result in a small clinically unimportant improvement in QoL at discharge from the hospital compared to controls (4 studies, 875 participants; low-certainty evidence). Mean QoL on the EuroQol 5 Dimensions (EQ-5D) visual analogue scale (VAS) (scale: 0 to 100, higher scores representing better QoL) ranged between 48.9 and 64.7 in the control group at discharge from the hospital, and QoL was 6.04 points better (0.9 better to 11.18 better) with exercise. A change of 10 points on the EQ-5D VAS represents an MCID.\nNo studies measured participant global assessment of success.\nExercise interventions did not affect the risk of falls during hospitalisation (moderate-certainty evidence). The incidence of falls was 31/899 (34 per 1000) in the control group compared with 31/888 (34 per 1000; range 20 to 57) in the exercise group (RR 0.99, 95% CI 0.59 to 1.65).\nWe are uncertain regarding the effect of exercise on the incidence of medical deterioration during hospitalisation (very low-certainty evidence). The incidence of medical deterioration in the control group was 101/1417 (71 per 1000) compared with 96/1313 (73 per 1000; range 44 to 120) in the exercise group (RR 1.02, 95% CI 0.62 to 1.68).\nSubgroup analyses by different intervention categories and by the use of a sham intervention were not meaningfully different from the main analyses.\nAuthors' conclusions\nExercise may make little difference to independence in activities of daily living or QoL, but probably does not result in more falls in older medical inpatients. We are uncertain about the effect of exercise on functional mobility, incidence of delirium and medical deterioration. Certainty of evidence was limited by risk of bias and inconsistency. Future primary research on the effect of exercise on acute hospitalisation could focus on more consistent and uniform reporting of participant's characteristics including their baseline level of functional ability, as well as exercise dose, intensity and adherence that may provide an insight into the reasons for the observed inconsistencies in findings.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases for studies that compared exercise programmes to usual care (with or without a sham (fake) intervention). Usual care was the treatment that would normally be given to patients who were not part of the research studies. Two studies used sham interventions in addition to usual care. The sham interventions were not designed to impact the patients' recovery, but to add a level of trustworthiness to the research studies."
}
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query-laysum | 5010 | [
{
"role": "user",
"content": "Abstract: Background\nThe role of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC) is evolving. We undertook a systematic review to evaluate the available evidence from all randomised trials.\nObjectives\nTo determine the effectiveness and safety of gefitinib as first-line, second-line or maintenance treatment for advanced NSCLC.\nSearch methods\nWe performed searches in CENTRAL, MEDLINE and Embase from inception to 17 February 2017. We handsearched relevant conference proceedings, clinical trial registries and references lists of retrieved articles.\nSelection criteria\nWe included trials assessing gefitinib, alone or in combination with other treatment, compared to placebo or other treatments in the first- or successive-line treatment of patients with NSCLC, excluding compassionate use.\nData collection and analysis\nWe used the standard Cochrane methodology. Two authors independently assessed the search results to select those with sound methodological quality. We carried out all analyses on an intention-to-treat basis. We recorded the following outcome data: overall survival, progression-free survival, toxicity, tumour response and quality of life. We also collected data for the following subgroups: Asian ethnicity and positive epidermal growth factor receptor (EGFR) mutation.\nMain results\nWe included 35 eligible randomised controlled trials (RCTs), which examined 12,089 patients.\nGeneral population\nGefitinib did not statistically improve overall survival when compared with placebo or chemotherapy in either first- or second-line settings. Second-line gefitinib prolonged time to treatment failure (TTF) (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75 to 0.90, P < 0.0001) when compared with placebo. Maintenance gefitinib improved progression-free survival (HR 0.70, 95% CI 0.53 to 0.91, P = 0.007) after first-line therapy.\nStudies in patients of Asian ethnicity or that conducted subgroup analyses\nSecond-line gefitinib prolonged overall survival over placebo (HR 0.66, 95% CI 0.48 to 0.91, P = 0.01). In the first-line setting, progression-free survival was improved with gefitinib over chemotherapy alone (HR 0.65, 95% CI 0.43 to 0.98, P = 0.04, moderate quality of evidence). Gefitinib given in combination with a chemotherapy regimen improved progression-free survival versus either gefitinib alone or chemotherapy alone (HR 0.69, 95% CI 0.49 to 0.96, P = 0.03; HR 0.69, 95% CI 0.62 to 0.77, P < 0.00001, respectively). In the second-line setting, progression-free survival was superior in patients given gefitinib over placebo or chemotherapy (HR 0.69, 95% CI 0.52 to 0.91, P = 0.009; HR 0.71, 95% CI 0.57 to 0.88, P = 0.002; moderate quality of evidence, respectively). Combining gefitinib with chemotherapy in the second-line setting was superior to gefitinib alone (HR 0.65, 95% CI 0.43 to 0.97, P = 0.04). As maintenance therapy, gefitinib improved progression-free survival when compared with placebo (HR 0.42, 95% CI 0.33 to 0.54, P < 0.00001).\nPatients with EGFR mutation-positive tumours\nStudies in patients with EGFR mutation-positive tumours showed an improvement in progression-free survival in favour of gefitinib over first-line and second-line chemotherapy (HR 0.47, 95% CI 0.36 to 0.61, P < 0.00001; HR 0.24, 95% CI 0.12 to 0.47, P < 0.0001, respectively). Gefitinib as maintenance therapy following chemotherapy improved overall and progression-free survival (HR 0.39, 95% CI 0.15 to 0.98, P = 0.05; HR 0.17, 95% CI 0.07 to 0.41, P < 0.0001, respectively) in one phase III study when compared to placebo.\nToxicities from gefitinib included skin rash, diarrhoea and liver transaminase derangements. Toxicities from chemotherapy included anaemia, neutropenia and neurotoxicity.\nIn terms of quality of life, gefitinib improved Functional Assessment of Cancer Therapy-Lung (FACT-L) (standardised mean difference (SMD) 10.50, 95% CI 9.55 to 11.45, P < 0.000001), lung cancer subscale (SMD 3.63, 95% CI 3.08 to 4.19, P < 0.00001) and Trial Outcome Index (SMD 9.87, 95% CI 1.26 to 18.48, P < 0.00001) scores when compared with chemotherapy.\nAuthors' conclusions\nThis systematic review shows that gefitinib, when compared with standard first- or second-line chemotherapy or maintenance therapy, probably has a beneficial effect on progression-free survival and quality of life in selected patient populations, particularly those with tumours bearing sensitising EGFR mutations.\nPatients with EGFR mutations lived longer when given maintenance gefitinib than those given placebo.\nOne study conducted subgroup analysis and showed that gefitinib improved overall survival over placebo in the second-line setting in patients of Asian ethnicity. All other studies did not detect any benefit on overall survival. The data analysed in this review were very heterogenous. We were limited in the amount of data that could be pooled, largely due to variations in study design. The risk of bias in most studies was moderate, with some studies not adequately addressing potential selection, attrition and reporting bias. This heterogeneity may have an impact on the applicability of the results\nCombining gefitinib with chemotherapy appears to be superior in improving progression-free survival to either gefitinib or chemotherapy alone, however further data and phase III studies in these settings are required.\nGefitinib has a favourable toxicity profile when compared with current chemotherapy regimens. Although there is no improvement in overall survival, gefitinib compares favourably with cytotoxic chemotherapy in patients with EGFR mutations with a prolongation of progression-free survival and a lesser side effect profile.\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 patients with non-small cell lung cancer live longer if they are given gefitinib?"
}
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query-laysum | 5011 | [
{
"role": "user",
"content": "Abstract: Background\nTumour necrosis factor (TNF)-alpha inhibitors are beneficial for the treatment of rheumatoid arthritis (RA) for reducing the risk of joint damage, improving physical function and improving the quality of life. This review is an update of the 2014 Cochrane Review of the treatment of RA with certolizumab pegol.\nObjectives\nTo assess the clinical benefits and harms of certolizumab pegol (CZP) in people with RA who have not responded well to conventional disease-modifying anti-rheumatic drugs (DMARDs).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL: Cochrane Library 2016, Issue 9), MEDLINE, Embase, Web of Knowledge, reference lists of articles, clinicaltrials.gov and ICTRP of WHO. The searches were updated from 2014 (date of the last search for the previous version) to 26 September 2016.\nSelection criteria\nRandomised controlled trials that compared certolizumab pegol with any other agent, including placebo or methotrexate (MTX), in adults with active RA, regardless of current or prior treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), such as MTX.\nData collection and analysis\nTwo review authors independently checked search results, extracted data and assessed trial quality. We resolved disagreements by discussion or referral to a third review author.\nMain results\nWe included 14 trials in this update, three more than previously. Twelve trials (5422 participants) included measures of benefit. We pooled 11 of them, two more than previously. Thirteen trials included information on harms, (5273 participants). The duration of follow-up varied from 12 to 52 weeks and the range of doses of certolizumab pegol varied from 50 to 400 mg given subcutaneously. In Phase III trials, the comparator was placebo plus MTX in seven trials and placebo in five. In the two Phase II trials the comparator was only placebo.\nThe approved dose of certolizumab pegol, 200 mg every other week, produced clinically important improvements at 24 weeks for the following outcomes:\n- American College of Rheumatology (ACR) 50% improvement (pain, function and other symptoms of RA): 25% absolute improvement (95% confidence interval (CI) 20% to 33%); number need to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 5); risk ratio (RR) 3.80 (95% CI 2.42 to 5.95), 1445 participants, 5 studies.\n- The Health Assessment Questionnaire (HAQ): -12% absolute improvement (95% CI -9% to -14%); NNTB of 8 (95% CI 7 to 11); mean difference (MD) - 0.35 (95% CI -0.43 to -0.26; 1268 participants, 4 studies) (scale 0 to 3; lower scores mean better function).\n- Proportion of participants achieving remission (Disease Activity Score (DAS) < 2.6) absolute improvement 10% (95% CI 8% to 16%); NNTB of 8 (95% CI 6 to 12); risk ratio (RR) 2.94 (95% CI 1.64 to 5.28), 2420 participants, six studies.\n- Radiological changes: erosion score (ES) absolute improvement -0.29% (95% CI -0.42% to -0.17%); NNTB of 6 (95% CI 4 to 10); MD -0.67 (95% CI -0.96 to -0.38); 714 participants, two studies (scale 0 to 230), but not a clinically important difference.\n-Serious adverse events (SAEs) were statistically but not clinically significantly more frequent for certolizumab pegol (200 mg every other week) with an absolute rate difference of 3% (95% CI 1% to 4%); number needed to treat for an additional harmful outcome (NNTH) of 33 (95% CI 25 to 100); Peto odds ratio (OR) 1.47 (95% CI 1.13 to 1.91); 3927 participants, nine studies.\nThere was a clinically significant increase in all withdrawals in the placebo groups (for all doses and at all follow-ups) with an absolute rate difference of -29% (95% CI -16% to -42%), NNTH of 3 (95% CI 2 to 6), RR 0.47 (95% CI 0.39 to 0.56); and there was a clinically significant increase in withdrawals due to adverse events in the certolizumab groups (for all doses and at all follow-ups) with an absolute rate difference of 2% (95% CI 0% to 3%); NNTH of 58 (95% CI 28 to 329); Peto OR 1.45 (95% CI 1.09 to 1.94) 5236 participants Twelve studies.\nWe judged the quality of evidence to be high for ACR50, DAS remission, SAEs and withdrawals due to adverse events, and moderate for HAQ and radiological changes, due to concerns about attrition bias. For all withdrawals we judged the quality of evidence to be moderate, due to inconsistency.\nAuthors' conclusions\nThe results and conclusions did not change from the previous review. There is a moderate to high certainty of evidence from randomised controlled trials that certolizumab pegol, alone or combined with methotrexate, is beneficial in the treatment of RA for improved ACR50 and health-related quality of life, an increased chance of remission of RA, and reduced joint damage as seen on x-ray. Fewer people stopped taking their treatment, but most of these who did stopped due to serious adverse events. Adverse events were more frequent with active treatment. We found a clinically but not statistically significant risk of serious adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What happens to people with rheumatoid arthritis who take certolizumab pegol 200 mg every other week after six months?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
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query-laysum | 5012 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic kidney disease (DKD) continues to be the leading cause of kidney failure across the world. For decades dietary protein restriction has been proposed for patients with DKD with the aim to retard the progression of chronic kidney disease (CKD) towards kidney failure. However, the relative benefits and harms of dietary protein restriction for slowing the progression of DKD have not been addressed.\nObjectives\nTo determine the efficacy and safety of low protein diets (LPD) (0.6 to 0.8 g/kg/day) in preventing the progression of CKD towards kidney failure and in reducing the incidence of kidney failure and death (any cause) in adult patients with DKD. Moreover, the effect of LPD on adverse events (e.g. malnutrition, hyperglycaemic events, or health-related quality of life (HRQoL)) and compliance were also evaluated.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 17 November 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs in which adults with DKD not on dialysis were randomised to receive either a LPD (0.6 to 0.8 g/kg/day) or a usual or unrestricted protein diet (UPD) (≥ 1.0 g/kg/day) for at least 12 months.\nData collection and analysis\nTwo authors independently selected studies and extracted data. Summary estimates of effect were obtained using a random-effects model. Results were summarised as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) or standardised MD (SMD) with 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe identified eight studies involving 486 participants with DKD. The prescribed protein intake in the intervention groups ranged from 0.6 to 0.8 g/kg/day. The prescribed protein intake in the control groups was ≥ 1.0 g/kg/day, or a calculated protein intake ≥ 1.0 g/kg/day if data on prescribed protein intake were not provided. The mean duration of the interventions was two years (ranging from one to five years). Risks of bias in most of the included studies were high or unclear, most notably for allocation concealment, performance and detection bias. All studies were considered to be at high risk for performance bias due to the nature of the interventions.\nMost studies were not designed to examine death or kidney failure. In low certainty evidence, a LPD may have little or no effect on death (5 studies, 358 participants: RR 0.38, 95% CI 0.10 to 1.44; I² = 0%), and the number of participants who reached kidney failure (4 studies, 287 participants: RR 1.16, 95% CI 0.38 to 3.59; I² = 0%). Compared to a usual or unrestricted protein intake, it remains uncertain whether a LPD slows the decline of glomerular filtration rate over time (7 studies, 367 participants: MD -0.73 mL/min/1.73 m²/year, 95% CI -2.3 to 0.83; I² = 53%; very low certainty evidence).\nIt is also uncertain whether the restriction of dietary protein intake impacts on the annual decline in creatinine clearance (3 studies, 203 participants: MD -2.39 mL/min/year, 95% CI -5.87 to 1.08; I² = 53%). There was only one study reporting 24-hour urinary protein excretion. In very low certainty evidence, a LPD had uncertain effects on the annual change in proteinuria (1 study, 80 participants: MD 0.90 g/24 hours, 95% CI 0.49 to 1.31). There was no evidence of malnutrition in seven studies, while one study noted this condition in the LPD group. Participant compliance with a LPD was unsatisfactory in nearly half of the studies. One study reported LPD had no effect on HRQoL. No studies reported hyperglycaemic events.\nAuthors' conclusions\nDietary protein restriction has uncertain effects on changes in kidney function over time. However, it may make little difference to the risk of death and kidney failure. Questions remain about protein intake levels and compliance with protein-restricted diets. There are limited data on HRQoL and adverse effects such as nutritional measures and hyperglycaemic events. Large-scale pragmatic RCTs with sufficient follow-up are required for different stages of CKD.\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 identified eight studies enrolling 486 people who had DKD at different stages of chronic kidney disease. Studies included type 1 and type 2 diabetes. The results showed that a low protein diet has uncertain effects on slowing the decline of glomerular filtration rate. Compared with a usual or unrestricted protein diet, a low protein diet may have little or no effect on the number of people who died or progress to kidney failure needing dialysis. The vast majority of studies reported nutritional status, with only one study indicating potential malnutrition in the low protein diet group. There may be little or no difference in health-related quality of life; however, only one study reported this outcome. Compliance with the low protein diet was unsatisfactory in four of the eight studies\nFor the most part, the included studies were poorly conducted, and data were often not reported; therefore, the overall certainty of the evidence for our outcomes of interest was either low or very low."
}
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query-laysum | 5013 | [
{
"role": "user",
"content": "Abstract: Background\nRetrospective analyses suggest that capecitabine may carry superior activity in hormone receptor-positive relative to hormone receptor-negative metastatic breast cancer. This review examined the veracity of that finding and explored whether this differential activity extends to early breast cancer.\nObjectives\nTo assess effects of chemotherapy regimens containing capecitabine compared with regimens not containing capecitabine for women with hormone receptor-positive versus hormone receptor-negative breast cancer across the three major treatment scenarios: neoadjuvant, adjuvant, metastatic.\nSearch methods\nOn 4 June 2019, we searched the Cochrane Breast Cancer Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) in the Cochrane Library; MEDLINE; Embase; the World Health Organization International Clinical Trials Registry Platform; and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials looking at chemotherapy regimens containing capecitabine alone or in combination with other agents versus a control or similar regimen without capecitabine for treatment of breast cancer at any stage. The primary outcome measure for metastatic and adjuvant trials was overall survival (OS), and for neoadjuvant studies pathological complete response (pCR).\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. Hazard ratios (HRs) were derived for time-to-event outcomes, and odds ratios (ORs) for dichotomous outcomes, and meta-analysis was performed using a fixed-effect model.\nMain results\nWe included 26 studies with outcome data by hormone receptor: 12 metastatic studies (n = 4325), 6 neoadjuvant trials (n = 3152), and 8 adjuvant studies (n = 13,457).\nCapecitabine treatment was added in several different ways across studies. These could be classified as capecitabine alone compared to another treatment, capecitabine substituted for part of the control chemotherapy, and capecitabine added to control chemotherapy.\nIn the metastatic setting, the effect of capecitabine was heterogenous between hormone receptor-positive and -negative tumours. For OS, no difference between capecitabine-containing and non-capecitabine-containing regimens was observed for all participants taken together (HR 1.01, 95% confidence interval (CI) 0.98 to 1.05; 12 studies, 4325 participants; high-certainty evidence), for those with hormone receptor-positive disease (HR 0.93, 95% CI 0.84 to 1.04; 7 studies, 1834 participants; high-certainty evidence), and for those with hormone receptor-negative disease (HR 1.00, 95% CI 0.88 to 1.13; 8 studies, 1577 participants; high-certainty evidence). For progression-free survival (PFS), a small improvement was seen for all people (HR 0.89, 95% CI 0.82 to 0.96; 12 studies, 4325 participants; moderate-certainty evidence). This was largely accounted for by a moderate improvement in PFS for inclusion of capecitabine in hormone receptor-positive cancers (HR 0.82, 95% CI 0.73 to 0.91; 7 studies, 1594 participants; moderate-certainty evidence) compared to no difference in PFS for hormone receptor-negative cancers (HR 0.96, 95% CI 0.83 to 1.10; 7 studies, 1122 participants; moderate-certainty evidence). Quality of life was assessed in five studies; in general there did not seem to be differences in global health scores between the two treatment groups at around two years' follow-up.\nNeoadjuvant studies were highly variable in design, having been undertaken to test various experimental regimens using pathological complete response (pCR) as a surrogate for disease-free survival (DFS) and OS. Across all patients, capecitabine-containing regimens resulted in little difference in pCR in comparison to non-capecitabine-containing regimens (odds ratio (OR) 1.12, 95% CI 0.94 to 1.33; 6 studies, 3152 participants; high-certainty evidence). By subtype, no difference in pCR was observed for either hormone receptor-positive (OR 1.22, 95% CI 0.76 to 1.95; 4 studies, 964 participants; moderate-certainty evidence) or hormone receptor-negative tumours (OR 1.28, 95% CI 0.61 to 2.66; 4 studies, 646 participants; moderate-certainty evidence). Four studies with 2460 people reported longer-term outcomes: these investigators detected no difference in either DFS (HR 1.02, 95% CI 0.86 to 1.21; high-certainty evidence) or OS (HR 0.97, 95% CI 0.77 to 1.23; high-certainty evidence).\nIn the adjuvant setting, a modest improvement in OS was observed across all participants (HR 0.89, 95% CI 0.81 to 0.98; 8 studies, 13,547 participants; moderate-certainty evidence), and no difference in OS was seen in hormone receptor-positive cancers (HR 0.86, 95% CI 0.68 to 1.09; 3 studies, 3683 participants), whereas OS improved in hormone receptor-negative cancers (HR 0.72, 95% CI 0.59 to 0.89; 5 studies, 3432 participants). No difference in DFS or relapse-free survival (RFS) was observed across all participants (HR 0.93, 95% CI 0.86 to 1.01; 8 studies, 13,457 participants; moderate-certainty evidence). As was observed for OS, no difference in DFS/RFS was seen in hormone receptor-positive cancers (HR 1.03, 95% CI 0.91 to 1.17; 5 studies, 5604 participants; moderate-certainty evidence), and improvements in DFS/RFS with inclusion of capecitabine were observed for hormone receptor-negative cancers (HR 0.74, 95% CI 0.64 to 0.86; 7 studies, 3307 participants; moderate-certainty evidence).\nAdverse effects were reported across all three scenarios. When grade 3 or 4 febrile neutropenia was considered, no difference was seen for capecitabine compared to non-capecitabine regimens in neoadjuvant studies (OR 1.31, 95% CI 0.97 to 1.77; 4 studies, 2890 participants; moderate-certainty evidence), and a marked reduction was seen for capecitabine in adjuvant studies (OR 0.55, 95% CI 0.47 to 0.64; 5 studies, 8086 participants; moderate-certainty evidence). There was an increase in diarrhoea and hand-foot syndrome in neoadjuvant (diarrhoea: OR 1.95, 95% CI 1.32 to 2.89; 3 studies, 2686 participants; hand-foot syndrome: OR 6.77, 95% CI 4.89 to 9.38; 5 studies, 3021 participants; both moderate-certainty evidence) and adjuvant trials (diarrhoea: OR 2.46, 95% CI 2.01 to 3.01; hand-foot syndrome: OR 13.60, 95% CI 10.65 to 17.37; 8 studies, 11,207 participants; moderate-certainty evidence for both outcomes).\nAuthors' conclusions\nIn summary, a moderate PFS benefit by including capecitabine was seen only in hormone receptor-positive cancers in metastatic studies. No benefit of capecitabine for pCR was noted overall or in hormone receptor subgroups when included in neoadjuvant therapy. In contrast, the addition of capecitabine in the adjuvant setting led to improved outcomes for OS and DFS in hormone receptor-negative cancer. Future studies should stratify by hormone receptor and triple-negative breast cancer (TNBC) status to clarify the differential effects of capecitabine in these subgroups across all treatment scenarios, to optimally guide capecitabine inclusion.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In the setting of advanced disease, there was a modest increase in time to cancer progression (how long cancer growth is stopped) with the addition of capecitabine in hormone receptor-positive but not in hormone receptor-negative breast cancer, although no survival benefit was seen in either group. However, when broken down by how capecitabine was added to the regimen, the addition of capecitabine to other chemotherapy was most effective, demonstrating both longer time to progression in both groups and improved survival in hormone receptor-positive cancers.\nIn the neoadjuvant setting, capecitabine-containing chemotherapy regimens showed no difference compared with non-capecitabine-containing chemotherapy regimens: no significant impact on the pathological complete response rate (the proportion of patients for whom all traces of cancer in the breast have been eradicated by treatment by the time of surgery), on disease-free survival (the number of people who remain cancer-free at a certain time after surgery), or on overall survival, regardless of hormone receptor subgroup.\nIn the adjuvant setting, there was a small benefit for overall survival with capecitabine-containing compared to non-capecitabine-containing chemotherapy regimens, when all patients were looked at together. In triple-negative and hormone receptor-negative breast cancers, reductions in both cancer return rates and deaths from breast cancer were substantial for capecitabine-containing chemotherapy regimens compared with non-capecitabine-containing regimens. In contrast, for hormone receptor-positive breast cancers, there was no significant impact of capecitabine on either cancer return rates or deaths from cancer.\nThe common side effects of capecitabine were as expected, with the most common being diarrhoea and hand-foot syndrome (redness, tightness, and discomfort or pain in the soles and palms)."
}
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query-laysum | 5014 | [
{
"role": "user",
"content": "Abstract: Background\nSleep disorders are commonly experienced by people with chronic kidney disease (CKD). Several approaches for improving sleep quality are used in clinical practice including relaxation techniques, exercise, acupressure, and medication.\nObjectives\nTo assess the effectiveness and associated adverse events of interventions designed to improve sleep quality among adults and children with CKD including people with end-stage kidney disease (ESKD) treated with dialysis or kidney transplantation.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 8 October 2018 with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-randomised RCTs of any intervention in which investigators reported effects on sleep quality. Two authors independently screened titles and abstracts of identified records.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias for included studies. The primary outcomes were sleep quality, sleep onset latency, sleep duration, sleep interruption, and sleep efficiency. Risks of bias were assessed using the Cochrane tool. Evidence certainty was assessed using the GRADE approach. We calculated treatment estimates as risk ratios (RR) for dichotomous outcomes or mean difference (MD) or standardised MD (SMD) for continuous outcomes to account for heterogeneity in measures of sleep quality.\nMain results\nSixty-seven studies involving 3427 participants met the eligibility criteria. Thirty-six studies involving 2239 participants were included in meta-analyses. Follow-up for clinical outcomes ranged between 0.3 and 52.8 weeks (median 5 weeks). Interventions included relaxation techniques, exercise, acupressure, cognitive-behavioural therapy (CBT), educational interventions, benzodiazepine treatment, dopaminergic agonists, telephone support, melatonin, reflexology, light therapy, different forms of peritoneal dialysis, music, aromatherapy, and massage. Incomplete reporting of key methodological details resulted in uncertain risk of bias in many studies.\nIn very low certainty evidence relaxation techniques had uncertain effects on sleep quality and duration, health-related quality of life (HRQoL), depression, anxiety, and fatigue. Studies were not designed to evaluate the effects of relaxation on sleep latency or hospitalisation. Exercise had uncertain effects on sleep quality (SMD -1.10, 95% CI -2.26 to 0.05; I2 = 90%; 5 studies, 165 participants; very low certainty evidence). Exercise probably decreased depression (MD -9.05, 95% CI -13.72 to -4.39; I2 = 0%; 2 studies, 46 participants; moderate certainty evidence) and fatigue (SMD -0.68, 95% CI -1.07 to -0.29; I2 = 0%; 2 studies, 107 participants; moderate certainty evidence). Compared with no acupressure, acupressure had uncertain effects on sleep quality (Pittsburgh Sleep Quality Index (PSQI) scale 0 - 21) (MD -1.27, 95% CI -2.13 to -0.40; I2 = 89%; 6 studies, 367 participants: very low certainty evidence). Acupressure probably slightly improved sleep latency (scale 0 - 3) (MD -0.59, 95% CI -0.92 to -0.27; I2 = 0%; 3 studies, 173 participants; moderate certainty evidence) and sleep time (scale 0 - 3) (MD -0.60, 95% CI -1.12 to -0.09; I2 = 68%; 3 studies, 173 participants; moderate certainty evidence), although effects on sleep disturbance were uncertain as the evidence certainty was very low (scale 0 - 3) (MD -0.49, 95% CI -1.16 to 0.19; I2 = 97%). In moderate certainty evidence, acupressure probably decrease fatigue (MD -1.07, 95% CI -1.67 to -0.48; I2 = 0%; 2 studies, 137 participants). Acupressure had uncertain effects on depression (MD -3.65, 95% CI -7.63 to 0.33; I2 = 27%; 2 studies, 137 participants; very low certainty evidence) while studies were not designed to evaluate the effect of acupressure on HRQoL, anxiety, or hospitalisation. It was uncertain whether acupressure compared with sham acupressure improved sleep quality (PSQI scale 0 to 21) because the certainty of the evidence was very low (MD -2.25, 95% CI -6.33 to 1.82; I2 = 96%; 2 studies, 129 participants), but total sleep time may have been improved (SMD -0.34, 95% CI -0.73 to 0.04; I2 = 0%; 2 studies, 107 participants; low certainty evidence). 2 =2 =There were no studies designed to directly examine and/or correlate efficacy of any interventions aimed at improving sleep that may have been attempted for the spectrum of sleep disordered breathing. No studies reported treatment effects for children. Adverse effects of therapies were very uncertain.\nAuthors' conclusions\nThe evidence base for improving sleep quality and related outcomes for adults and children with CKD is sparse. Relaxation techniques and exercise had uncertain effects on sleep outcomes. Acupressure may improve sleep latency and duration, although these findings are based on few studies. The effects of acupressure were not confirmed in studies in which sham acupressure was used as the control. Given the very low certainly evidence, future research will very likely change the evidence base. Based on the importance of symptom management to patients, caregivers and clinicians, future studies of sleep interventions among people with CKD should be a priority.\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 looked at electronic databases to find research studies of any treatment that was designed to help with sleep problems. Studies needed to be randomised (in other words, patients needed to have an equal chance that they might receive one of the treatments in the study). We collected information from the studies and combined this to identify whether treatment was helpful or if there were important side-effects. We looked at how certain we could be that the treatments had any effects based on how well the studies were conducted (quality). The information in this review is up to date as of October 2018."
}
]
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query-laysum | 5015 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is the most common, life-threatening, recessively inherited disease of Caucasian populations. It is a multisystem disorder caused by a mutation in the gene encoding the cystic fibrosis transmembrane conductance regulator protein which is important in producing sweat, digestive juices and mucus.The impaired or absent function of this protein results in the production of viscous mucus within the lungs and an environment that is susceptible to chronic airway obstruction and pulmonary colonization by a range of pathogenic bacteria. Morbidity and mortality of cystic fibrosis is related to chronic pulmonary sepsis and its complications by these bacteria.\nInfluenza can worsen the course of the disease in cystic fibrosis by increasing the risk of pneumonia and secondary respiratory complications. Antiviral agents form an important part of influenza management and include the neuraminidase inhibitors zanamivir and oseltamivir. These inhibitors can limit the infection and prevent the spread of the virus.\nObjectives\nTo assess the effects of neuraminidase inhibitors for the treatment of influenza infection in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.\nMost recent search: 02 November 2015.\nSelection criteria\nRandomised controlled trials and quasi-randomised controlled trials comparing neuraminidase inhibitors with placebo or other antiviral drugs.\nData collection and analysis\nTwo review authors had planned to independently screen studies, extract data and assess risk of bias using standard Cochrane methodologies. No studies were identified for inclusion.\nMain results\nNo relevant studies were retrieved after a comprehensive search of the literature.\nAuthors' conclusions\nWe were unable to identify any randomised controlled studies or quasi-randomised controlled studies on the efficacy of neuraminidase inhibitors for the treatment of influenza infection in people with cystic fibrosis. The absence of high level evidence for the effectiveness of these interventions emphasises the need for well-designed, adequately powered, randomised controlled clinical studies.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Limited data from previous studies have shown that these drugs can be effective in healthy people and may be useful in high-risk populations if used rationally. However, we are not able to answer the question of the safety and effectiveness of neuraminidase inhibitors for treating influenza in people with cystic fibrosis."
}
]
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query-laysum | 5016 | [
{
"role": "user",
"content": "Abstract: Background\nParacetamol, either alone or in combination with codeine or dihydrocodeine, is commonly used to treat chronic neuropathic pain. This review sought evidence for efficacy and harm from randomised double-blind studies.\nObjectives\nTo assess the analgesic efficacy and adverse events of paracetamol with or without codeine or dihydrocodeine for chronic neuropathic pain in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to July 2016, together with reference lists of retrieved papers and reviews, and two online study registries.\nSelection criteria\nWe included randomised, double-blind studies of two weeks' duration or longer, comparing paracetamol, alone or in combination with codeine or dihydrocodeine, with placebo or another active treatment in chronic neuropathic pain.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE.\nMain results\nNo study satisfied the inclusion criteria. Effects of interventions were not assessed as there were no included studies. We have only very low quality evidence and have no reliable indication of the likely effect.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the suggestion that paracetamol alone, or in combination with codeine or dihydrocodeine, works in any neuropathic pain condition.\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": "Because there were no studies that could answer the questions in a reliable way, we cannot say whether paracetamol alone, or in combination with codeine or dihydrocodeine, works for chronic neuropathic pain."
}
]
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query-laysum | 5017 | [
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) has major short- and long-term implications for both the mother and her baby. GDM is defined as a carbohydrate intolerance resulting in hyperglycaemia or any degree of glucose intolerance with onset or first recognition during pregnancy from 24 weeks' gestation onwards and which resolves following the birth of the baby. Rates for GDM can be as high as 25% depending on the population and diagnostic criteria used, and overall rates are increasing globally. There is wide variation internationally in glycaemic treatment target recommendations for women with GDM that are based on consensus rather than high-quality trials.\nObjectives\nTo assess the effect of different intensities of glycaemic control in pregnant women with GDM on maternal and infant health outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (26 September 2022), and reference lists of the retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs, and quasi-RCTs. Trials were eligible for inclusion if women were diagnosed with GDM during pregnancy and the trial compared tighter and less-tight glycaemic targets during management. We defined tighter glycaemic targets as lower numerical glycaemic concentrations, and less-tight glycaemic targets as higher numerical glycaemic concentrations.\nData collection and analysis\nWe used standard Cochrane methods for carrying out data collection, assessing risk of bias, and analysing results. Two review authors independently assessed trial eligibility for inclusion, evaluated risk of bias, and extracted data for the four included studies. We assessed the certainty of evidence for selected outcomes using the GRADE approach. Primary maternal outcomes included hypertensive disorders of pregnancy and subsequent development of type 2 diabetes. Primary infant outcomes included perinatal mortality, large-for-gestational-age, composite of mortality or serious morbidity, and neurosensory disability.\nMain results\nThis was an update of a previous review completed in 2016. We included four RCTs (reporting on 1731 women) that compared a tighter glycaemic control with less-tight glycaemic control in women diagnosed with GDM. Three studies were parallel RCTs, and one study was a stepped-wedged cluster-RCT. The trials took place in Canada, New Zealand, Russia, and the USA. We judged the overall risk of bias to be unclear. Two trials were only published in abstract form. Tight glycaemic targets used in the trials ranged between ≤ 5.0 and 5.1 mmol/L for fasting plasma glucose and ≤ 6.7 and 7.4 mmol/L postprandial. Less-tight targets for glycaemic control used in the included trials ranged between < 5.3 and 5.8 mmol/L for fasting plasma glucose and < 7.8 and 8.0 mmol/L postprandial.\nFor the maternal outcomes, compared with less-tight glycaemic control, the evidence suggests a possible increase in hypertensive disorders of pregnancy with tighter glycaemic control (risk ratio (RR) 1.16, 95% confidence interval (CI) 0.80 to 1.69, 2 trials, 1491 women; low certainty evidence); however, the 95% CI is compatible with a wide range of effects that encompass both benefit and harm. Tighter glycaemic control likely results in little to no difference in caesarean section rates (RR 0.98, 95% CI 0.82 to 1.17, 3 studies, 1662 women; moderate certainty evidence) or induction of labour rates (RR 0.96, 95% CI 0.78 to 1.18, 1 study, 1096 women; moderate certainty evidence) compared with less-tight control. No data were reported for the outcomes of subsequent development of type 2 diabetes, perineal trauma, return to pre-pregnancy weight, and postnatal depression.\nFor the infant outcomes, it was difficult to determine if there was a difference in perinatal mortality (RR not estimable, 2 studies, 1499 infants; low certainty evidence), and there was likely no difference in being large-for-gestational-age (RR 0.96, 95% CI 0.72 to 1.29, 3 studies, 1556 infants; moderate certainty evidence). The evidence suggests a possible reduction in the composite of mortality or serious morbidity with tighter glycaemic control (RR 0.84, 95% CI 0.55 to 1.29, 3 trials, 1559 infants; low certainty evidence); however, the 95% CI is compatible with a wide range of effects that encompass both benefit and harm. There is probably little difference between groups in infant hypoglycaemia (RR 0.92, 95% CI 0.72 to 1.18, 3 studies, 1556 infants; moderate certainty evidence). Tighter glycaemic control may not reduce adiposity in infants of women with GDM compared with less-tight control (mean difference −0.62%, 95% CI −3.23 to 1.99, 1 study, 60 infants; low certainty evidence), but the wide CI suggests significant uncertainty. We found no data for the long-term outcomes of diabetes or neurosensory disability.\nWomen assigned to tighter glycaemic control experienced an increase in the use of pharmacological therapy compared with women assigned to less-tight glycaemic control (RR 1.37, 95% CI 1.17 to 1.59, 4 trials, 1718 women). Tighter glycaemic control reducedadherence with treatment compared with less-tight glycaemic control (RR 0.41, 95% CI 0.32 to 0.51, 1 trial, 395 women).\nOverall the certainty of evidence assessed using GRADE ranged from low to moderate, downgraded primarily due to risk of bias and imprecision.\nAuthors' conclusions\nThis review is based on four trials (1731 women) with an overall unclear risk of bias. The trials provided data on most primary outcomes and suggest that tighter glycaemic control may increase the risk of hypertensive disorders of pregnancy. The risk of birth of a large-for-gestational-age infant and perinatal mortality may be similar between groups, and tighter glycaemic targets may result in a possible reduction in composite of death or severe infant morbidity. However, the CIs for these outcomes are wide, suggesting both benefit and harm.\nThere remains limited evidence regarding the benefit of different glycaemic targets for women with GDM to minimise adverse effects on maternal and infant health. Glycaemic target recommendations from international professional organisations vary widely and are currently reliant on consensus given the lack of high-certainty evidence.\nFurther high-quality trials are needed, and these should assess both short- and long-term health outcomes for women and their babies; include women's experiences; and assess health services costs in order to confirm the current findings. Two trials are ongoing.\n\nGiven the provided abstract, please respond to the following query: \"Limitations of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is some uncertainty in the findings due to a lack of information about how some studies were designed and reported and because for some outcomes there was information from only one study."
}
]
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query-laysum | 5018 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding (HMB) is common in otherwise healthy women of reproductive age, and can affect physical health and quality of life. Surgery is usually a second-line treatment of HMB. Endometrial resection/ablation (EA/ER) to remove or ablate the endometrium is less invasive than hysterectomy. Hysterectomy is the definitive treatment and can be via open (laparotomy) approach, or via minimally invasive approaches (vaginally or laparoscopically). Each approach has its own advantages and risk profile.\nObjectives\nTo compare the effectiveness, acceptability and safety of endometrial resection or ablation versus different routes of hysterectomy (open, minimally invasive hysterectomy, or unspecified route) for the treatment of HMB.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase and PsycINFO (July 2020), and reference lists, grey literature and trial registers.\nSelection criteria\nRandomised controlled trials (RCTs) that compared techniques of endometrial resection/ablation with hysterectomy (by any technique) for the treatment of HMB in premenopausal women.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 10 RCTs (1966 participants) comparing EA/ER to hysterectomy (open (abdominal), minimally invasive (laparoscopic or vaginal), or unspecified (or at surgeon's discretion) route of hysterectomy). The results were rated as moderate-, low- and very low-certainty evidence.\nEndometrial resection/ablation versus open hysterectomy\nWe found two trials. Women having EA/ER are probably less likely to perceive an improvement in HMB compared to women having open hysterectomy (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.95; 2 studies, 247 women; moderate-certainty evidence) and probably have a 13% risk of requiring further surgery for treatment failure (compared to 0 on the open hysterectomy group; 2 studies, 247 women; moderate-certainty evidence). Both treatments probably lead to similar quality of life at two years (mean difference (MD) –5.30, 95% CI –11.90 to 1.30; 1 study, 155 women; moderate-certainty evidence) and satisfaction rate at one year (RR 0.91, 95% CI 0.82 to 1.00; 1 study, 194 women; moderate-certainty evidence). There may be no difference in serious adverse events (RR 1.29, 95% CI 0.32 to 5.20; 2 studies, 247 women; low-certainty evidence). EA/ER probably reduces time to return to normal activity compared to open hysterectomy (MD –21.00 days, 95% CI –24.78 to –17.22; 1 study, 197 women; moderate-certainty evidence).\nEndometrial resection/ablation versus minimally invasive hysterectomy\nWe found five trials. The proportion of women with perception of improvement in HMB at two years may be similar between groups (RR 0.97, 95% CI 0.90 to 1.04; 1 study, 79 women; low-certainty evidence). Blood loss may be higher in the EA/ER group when assessed using the Pictorial Blood Assessment Chart (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women; low-certainty evidence). Quality of life is probably lower in the EA/ER group compared to the minimally invasive hysterectomy group at two years according to the 36-item Short Form (SF-36) (MD –10.71, 95% CI –15.11 to –6.30; 2 studies, 145 women; moderate-certainty evidence) and Menorrhagia Multi-Attribute Scale (RR 0.82, 95% CI 0.70 to 0.95; 1 study, 616 women; moderate-certainty evidence). EA/ER probably increases the risk of further surgery for HMB compared to minimally invasive hysterectomy (RR 7.70, 95% CI 2.54 to 23.32; 4 studies, 922 women; moderate-certainty evidence) and treatments probably have similar rates of any serious adverse events (RR 0.75, 95% CI 0.35 to 1.59; 4 studies, 809 women; moderate-certainty evidence). Women with EA/ER are probably less likely to be satisfied with treatment at one year (RR 0.90, 95% CI 0.85 to 0.94; 1 study, 558 women; moderate-certainty evidence). We were unable to pool data for time to return to work or normal life because of extreme heterogeneity (99%); however, the three studies reporting this all had the same direction of effect favouring EA/ER.\nEndometrial resection/ablation versus unspecified route of hysterectomy\nWe found three trials. EA/ER may lead to a lower perception of improvement in HMB compared to unspecified route of hysterectomy (RR 0.89, 95% CI 0.83 to 0.95; 2 studies, 403 women; low-certainty evidence). Although EA/ER may lead to similar quality of life using the SF-36 General Health Perception at two years' follow-up (MD –1.90, 95% CI –8.67 to 4.87; 1 study, 209 women; low-certainty evidence), the proportion of women with improvement in general health at one year may be lower (RR 0.85, 95% CI 0.77 to 0.95; 1 study, 185 women; low-certainty evidence). EA/ER probably has a risk of 5.4% of requiring further surgery for treatment failure (compared to 0 with total hysterectomy; 2 studies, 374 women; moderate-certainty evidence) and reduces the proportion of women with any serious adverse event (RR 0.21, 95% CI 0.06 to 0.80; 2 studies, 374 women; moderate-certainty evidence). Both treatments probably lead to a similar satisfaction rate at one year' follow-up (RR 0.96, 95% CI 0.88 to 1.04; 3 studies, 545 women; moderate-certainty evidence). EA/ER may lead to shorter time to return to normal activity (MD –18.90 days, 95% CI –24.63 to –13.17; 1 study, 172 women; low-certainty evidence).\nAuthors' conclusions\nEndometrial resection/ablation (EA/ER) offers an alternative to hysterectomy as a surgical treatment for HMB.\nEffectiveness varies with EA/ER compared to different hysterectomy approaches. The perception of improvement in HMB with EA/ER is probably lower compared to open and unspecified route of hysterectomy, but may be similar compared to minimally invasive. Quality of life with EA/ER is probably similar to open and unspecified route of hysterectomy, but lower compared to minimally invasive hysterectomy. Further surgery for treatment failure is probably more likely with EA/ER compared to all routes of hysterectomy.\nSatisfaction rates also vary. EA/ER probably has a similar rate of satisfaction compared to open and unspecified route of hysterectomy, but a lower rate of satisfaction compared to minimally invasive hysterectomy. The proportion having any serious adverse event appears similar in all groups, but specific adverse events did reported difference between EA/ER and different routes. We were unable to draw conclusions about the time to return to normal activity, but the direction of effect suggests it is likely to be shorter with EA/ER.\n\nGiven the provided abstract, please respond to the following query: \"Key results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Women having EA/ER are probably less likely to perceive an improvement in HMB and more likely to require surgery for treatment failure compared to women having open hysterectomy. They probably have a similar quality of life and satisfaction rates, and may also have similar proportions of serious side effects. Some uncommon but important complications, such as infection and bleeding, are more common during open hysterectomy than with EA/ER.\nWomen having EA/ER may have a similar rate of perceiving HMB improvement, but may be less likely to have an objective decrease in blood loss, compared to women having minimally invasive hysterectomy. The EA/ER group probably have a lower quality of life and satisfaction rate. The rate of serious side effects is probably similar but women having EA/ER are probably at increased risk of surgery for treatment failure when compared to minimally invasive hysterectomy. The time taken for women to return to normal activity was shorter with EA/ER than with minimally invasive hysterectomy.\nWomen having EA/ER may be less likely to perceive an improvement in HMB and an improvement in general health compared to women having an unspecified route of hysterectomy (or at surgeon's discretion). EA/ER probably increases the chances of having surgery for treatment failure, but decreases the chances of any serious side effects and has shorter time to return to normal activity if compared to the unspecified route of hysterectomy."
}
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query-laysum | 5019 | [
{
"role": "user",
"content": "Abstract: Background\nEarly discharge of stable preterm infants still requiring gavage feeds offers the benefits of uniting families sooner and reducing healthcare and family costs compared with discharge home when on full sucking feeds. Potential disadvantages of early discharge include increased care burden for the family and risk of complications related to gavage feeding.\nObjectives\nTo determine the effects of a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds.\nWe planned subgroup analyses to determine whether safety and efficacy outcomes are altered by the type of support received (outpatient visits vs home support) or by the maturity of the infants discharged (gestational age ≤ 28 weeks at birth or birth weight ≤ 1000 grams).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group, together with searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to March 2015), EMBASE (1980 to March 2015) and MEDLINE (1950 to March 2015). We found no new trials.\nSelection criteria\nWe included all randomised and quasi-randomised trials among infants born at < 37 weeks and requiring no intravenous nutrition at the point of discharge. Trials were required to compare early discharge home with gavage feeds and healthcare support versus later discharge home when full sucking feeds were attained.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We conducted study authors for additional information. We performed data analysis in accordance with the standards of the Cochrane Neonatal Review Group.\nMain results\nWe included in the review data from one quasi-randomised trial with 88 infants from 75 families. Infants in the early discharge programme with home gavage feeding had a mean hospital stay that was 9.3 days shorter (mean difference (MD) -9.3, 95% confidence interval (CI) -18.49 to -0.11) than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with those in the control group spending corresponding time in hospital (risk ratio 0.35, 95% CI 0.17 to 0.69). No significant differences were noted between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or overall health service use.\nAuthors' conclusions\nExperimental evidence on the benefits and risks for preterm infants of early discharge from hospital with home gavage feeding compared with later discharge upon attainment of full sucking feeds is limited to the results of one small quasi-randomised controlled trial. High-quality trials with concealed allocation, complete follow-up of all randomly assigned infants and adequate sample size are needed before practice recommendations can be made.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds lead to improvement in feeding, growth and other clinical outcomes?"
}
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query-laysum | 5020 | [
{
"role": "user",
"content": "Abstract: Background\nThyroid dysfunction pre-pregnancy and during pregnancy (both hyper- and hypothyroidism) is associated with increased risk of adverse outcomes for mothers and infants in the short- and long-term. Managing the thyroid dysfunction (e.g. thyroxine for hypothyroidism, or antithyroid medication for hyperthyroidism) may improve outcomes. The best method of screening to identify and subsequently manage thyroid dysfunction pre-pregnancy and during pregnancy is unknown.\nObjectives\nTo assess the effects of different screening methods (and subsequent management) for thyroid dysfunction pre-pregnancy and during pregnancy on maternal and infant outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (14 July 2015) and reference lists of retrieved studies.\nSelection criteria\nRandomised or quasi-randomised controlled trials, comparing any screening method (e.g. tool, program, guideline/protocol) for detecting thyroid dysfunction (including hypothyroidism, hyperthyroidism, and/or thyroid autoimmunity) pre-pregnancy or during pregnancy with no screening, or alternative screening methods.\nData collection and analysis\nTwo review authors independently assessed eligibility of studies, extracted and checked data accuracy, and assessed the risk of bias of included studies.\nMain results\nWe included two randomised controlled trials (involving 26,408 women) - these trials were considered to be at low risk of bias.\nUniversal screening (screening all women) versus case finding (screening only those at perceived increased risk) in pregnancy for thyroid dysfunction\nOne trial (4562 women) compared universal screening with case finding for thyroid dysfunction. Before 11 weeks' gestation, women in the universal screening group, and 'high-risk' women in the case finding group had their sera tested for TSH (thyroid stimulating hormone), fT4 (free thyroxine) and TPO-Ab (thyroid peroxidase antibody); women with hypothyroidism (TSH > 2.5 mIU/litre) received levothyroxine; women with hyperthyroidism (undetectable TSH and elevated fT4) received antithyroid medication.\nIn regards to this review's primary outcomes, compared with the case finding group, more women in the universal screening group were diagnosed with hypothyroidism (risk ratio (RR) 3.15, 95% confidence interval (CI) 1.91 to 5.20; 4562 women; GRADE: high quality evidence), with a trend towards more women being diagnosed with hyperthyroidism (RR 4.50, 95% CI 0.97 to 20.82; 4562 women; P = 0.05; GRADE: moderate quality evidence). No clear differences were seen in the risks of pre-eclampsia (RR 0.87, 95% CI 0.64 to 1.18; 4516 women; GRADE: moderate quality evidence), or preterm birth (RR 0.99, 95% CI 0.80 to 1.24; 4516 women; GRADE: high quality evidence) between groups. This trial did not report on neurosensory disability for the infant as a child.\nConsidering this review's secondary outcomes, more women in the universal screening group received pharmacological treatment for thyroid dysfunction (RR 3.15, 95% CI 1.91 to 5.20; 4562 women). No clear differences between groups were observed for miscarriage (RR 0.90, 95% CI 0.68 to 1.19; 4516 women; GRADE: moderate quality evidence), fetal and neonatal death (RR 0.92, 95% CI 0.42 to 2.02; 4516 infants; GRADE: moderate quality evidence), or other secondary outcomes: pregnancy-induced hypertension, gestational diabetes, congestive heart failure, thyroid storm, mode of birth (caesarean section), preterm labour, placental abruption, respiratory distress syndrome, low birthweight, neonatal intensive care unit admission, or other congenital malformations. The trial did not report on a number of outcomes including adverse effects associated with the intervention.\nUniversal screening versus no screening in pregnancy for hypothyroidism\nOne trial (21,846 women) compared universal screening with no screening for hypothyroidism. Before 15 + 6 weeks' gestation, women in the universal screening group had their sera tested; women who screened 'positive' (TSH > 97.5th percentile, fT4 < 2.5th percentile, or both) received levothyroxine.\nConsidering primary review outcomes, compared with the no screening group, more women in the universal screening screened 'positive' for hypothyroidism (RR 998.18, 95% CI 62.36 to 15,978.48; 21,839 women; GRADE: high quality evidence). No data were provided for the outcome pre-eclampsia, and for preterm birth, the trial reported rates of 5.6% and 7.9% for the screening and no screening groups respectively (it was unclear if these percentages related to the entire cohort or women who screened positive). No clear difference was seen for neurosensory disability for the infant as a child (three-year follow-up IQ score < 85) (RR 0.85, 95% CI 0.60 to 1.22; 794 infants; GRADE: moderate quality evidence).\nMore women in the universal screening group received pharmacological treatment for thyroid dysfunction (RR 1102.90, 95% CI 69.07 to 17,610.46; 1050 women); 10% had their dose lowered because of low TSH, high fT4 or minor side effects. No clear differences were observed for other secondary outcomes, including developmental delay/intellectual impairment at three years. Most of our secondary outcomes, including miscarriage, fetal or neonatal death were not reported.\nAuthors' conclusions\nBased on the existing evidence, though universal screening for thyroid dysfunction in pregnancy increases the number of women diagnosed with hypothyroidism who can be subsequently treated, it does not clearly impact (benefit or harm) maternal and infant outcomes.\nWhile universal screening versus case finding for thyroid dysfunction increased diagnosis and subsequent treatment, we found no clear differences for the primary outcomes: pre-eclampsia or preterm birth. No clear differences were seen for secondary outcomes, including miscarriage and fetal or neonatal death; data were lacking for the primary outcome: neurosensory disability for the infant as a child, and for many secondary outcomes. Though universal screening versus no screening for hypothyroidism similarly increased diagnosis and subsequent treatment, no clear difference was seen for the primary outcome: neurosensory disability for the infant as a child (IQ < 85 at three years); data were lacking for the other primary outcomes: pre-eclampsia and preterm birth, and for the majority of secondary outcomes.\nFor outcomes assessed using the GRADE approach the evidence was considered to be moderate or high quality, with any downgrading of the evidence based on the presence of wide confidence intervals crossing the line of no effect.\nMore evidence is needed to assess the benefits or harms of different screening methods for thyroid dysfunction in pregnancy, on maternal, infant and child health outcomes. Future trials should assess impacts on use of health services and costs, and be adequately powered to evaluate the effects on short- and long-term outcomes.\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 thyroid is a large gland in the neck that produces hormones that help to regulate the chemical processes in the body that maintain life, including growth and energy use. If a woman has an overactive thyroid (hyperthyroidism), or an underactive thyroid (hypothyroidism) in pregnancy which is not managed, there is a possibility of poor outcomes for the mother and her baby. The mother may be more likely to develop high blood pressure and protein in the urine (pre-eclampsia), give birth before 37 weeks of gestation (preterm birth), and her baby may develop disabilities (such as cerebral palsy, blindness, deafness and other developmental delays including intellectual impairment). Managing thyroid dysfunction in pregnancy (e.g. thyroxine for hypothyroidism, or antithyroid medication for hyperthyroidism) may improve outcomes for mothers and their babies. There are different methods of screening for thyroid dysfunction, including case finding, which means screening only pregnant women who are thought to be at high risk of thyroid dysfunction, or universal screening, which involves screening all pregnant women. Although universal screening may help to diagnose more women with hyperthyroidism or hypothyroidism than case finding, it could also lead to more women having medications and may be costly. It is not currently clear what the effects are of these different methods of screening for thyroid dysfunction for the mother and her baby, and health services."
}
]
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query-laysum | 5021 | [
{
"role": "user",
"content": "Abstract: Background\nGranulocyte-colony stimulating factor (G-CSF) seems to play an important role in the process of embryo implantation and continuation of pregnancy. It has been used during in vitro fertilisation (IVF) treatment for subfertile women with chronically thin endometrium and those with previous multiple IVF failures. It is currently unknown whether G-CSF is effective in improving results following assisted reproductive technology (ART).\nObjectives\nTo evaluate the effectiveness and safety of G-CSF in women undergoing ART.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform in February 2019. We searched reference lists of relevant articles and handsearched relevant conference proceedings.\nSelection criteria\nRandomised controlled trials (RCTs) comparing G-CSF administration versus no treatment or placebo in subfertile women undergoing IVF treatment.\nData collection and analysis\nTwo review authors independently screened studies, extracted data, and assessed risk of bias. The primary outcomes were live-birth rate and miscarriage rate following G-CSF administration. We have reported ongoing pregnancy rate in cases where studies did not report live birth but reported ongoing pregnancy. Secondary outcomes were clinical pregnancy rate, multiple pregnancy rate, adverse events, ectopic pregnancy rate, small for gestational age at birth, abnormally adherent placenta, and congenital anomaly rate. We analysed data using risk ratio (RR), Peto odds ratio and a fixed-effect model. We assessed the quality of the evidence using the GRADE criteria.\nMain results\nWe included 13 trials involving 522 women who received G-CSF and 528 women who received placebo or no additional treatment during IVF. The main limitations in the quality of the evidence were inadequate reporting of study methods and high risk of performance bias due to lack of blinding. We assessed only two of the 13 included trials as at a low risk of bias. None of the trials reported the primary effectiveness outcome of live-birth rate.\nWe are uncertain whether G-CSF administration improves ongoing pregnancy rate compared to control in subfertile women undergoing ART (RR 1.62, 95% confidence interval (CI) 0.86 to 3.08; 1 RCT; participants = 150; very low-quality evidence). For a typical clinic with 16% ongoing pregnancy rate, G-CSF administration would be expected to result in ongoing pregnancy rates between 14% and 50%. We are uncertain whether G-CSF administration reduces miscarriage rate (Peto odds ratio 0.40, 95% CI 0.09 to 1.77; 2 RCTs; participants = 291; I² = 0%; very low-quality evidence) compared to the control group in subfertile women undergoing ART.\nWe are uncertain whether G-CSF administration improves overall clinical pregnancy rate compared to control in subfertile women undergoing ART (RR 1.65, 95% CI 1.32 to 2.06; 12 RCTs; participants = 1050; I² = 19%; very low-quality evidence). For a typical clinic with 18% clinical pregnancy rate, G-CSF administration would be expected to result in clinical pregnancy rates between 23% and 37%. In the unselected IVF population, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.12, 95% CI 0.75 to 1.68; 2 RCTs; participants = 291; I² = 32%; low-quality evidence).\nSensitivity analysis restricted to studies at low-risk of bias suggests no evidence of difference in clinical pregnancy after G-CSF administration versus control group in an unselected IVF population ( RR 1.46, 95% CI 0.81 to 2.65; 1 RCT; participants = 150).\nG-CSF administration may improve clinical pregnancy rate in women with two or more previous IVF failures compared to the control group (RR 2.10, 95% CI 1.53 to 2.89; 6 RCTs; participants = 553; I² = 0%; low-quality evidence). However, sensitivity analysis restricted to studies at low-risk of selection bias suggests that there is no evidence of difference in clinical pregnancy rate after G-CSF administration versus control group in women with two or more IVF failures (RR 2.00, 95% CI 0.75 to 5.33; 1 RCT; participants =100). In subfertile women with thin endometrium undergoing ART, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.58, 95% CI 0.95 to 2.63; 4 RCTs; participants = 206; I² = 30%; low-quality evidence). No studies in this subgroup remained in a sensitivity analysis restricted to studies at low-risk of selection bias.\nNo study reported on multiple pregnancy rate. Only four trials reported adverse events as an outcome, and none of them reported any major adverse events following either G-CSF administration or placebo/no treatment.\nAuthors' conclusions\nIn subfertile women undergoing ART, we are uncertain whether the administration of G-CSF improves ongoing pregnancy or overall clinical pregnancy rates or reduces miscarriage rate compared to no treatment or placebo, whether in all women or those with thin endometrium, based on very low-quality evidence. Low-quality evidence suggests that G-CSF administration may improve clinical pregnancy rate in women with two or more IVF failures, but the included studies had unclear allocation concealment or were at high risk of performance bias.\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": "It has been suggested that in women who have persistent thin endometrium (inner lining of the womb) or who have experienced multiple failed IVF, giving G-CSF during treatment may improve IVF outcomes. G-CSF is a type of growth factor that stimulates bone marrow to produce certain types of white blood cells. In the endometrium, G-CSF promotes regenerative activity of the cells and helps in increasing the blood supply. It is proposed that G-CSF may increase IVF success by helping to improve embryo implantation (adherence to the lining of the womb) and facilitating continuation of pregnancy. It can be given either by injecting it inside the uterus (womb) with the help of a syringe around the time of embryo transfer or subcutaneously (under the skin) after embryo transfer."
}
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query-laysum | 5022 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is one of the most common neurological disorders. Approximately 30% of people with epilepsy are considered to be drug-resistant, and usually need treatment with a combination of other antiepileptic drugs. Perampanel is a newer antiepileptic drug that has been investigated as add-on therapy for drug-resistant focal epilepsy.\nObjectives\nTo evaluate the benefits and harms of perampanel as add-on therapy for people with drug-resistant focal epilepsy.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 20 October 2022.\nSelection criteria\nWe included randomised controlled trials comparing add-on perampanel with placebo.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was 1. 50% or greater reduction in seizure frequency. Our secondary outcomes were 2. seizure freedom, 3. treatment withdrawal due to any reason, 4. treatment withdrawal due to adverse effects, and 5. adverse effects. We used an intention-to-treat population for all primary analyses. We presented the results as risk ratios (RR) with 95% confidence intervals (CIs), except for individual adverse effects, which we reported with 99% CIs to compensate for multiple testing. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included seven trials involving 2524 participants, all aged over 12 years. The trials were double-blind, randomised, placebo-controlled trials with treatment duration of 12 to 19 weeks. We assessed four trials at overall low risk of bias, and three trials at overall unclear risk of bias, due to risk of detection, reporting, and other biases.\nCompared with placebo, participants receiving perampanel were more likely to achieve a 50% or greater reduction in seizure frequency (RR 1.67, 95% CI 1.43 to 1.95; 7 trials, 2524 participants; high-certainty evidence). Compared to placebo, perampanel increased seizure freedom (RR 2.50, 95% CI 1.38 to 4.54; 5 trials, 2323 participants; low-certainty evidence) and treatment withdrawal (RR 1.30, 95% CI 1.03 to 1.63; 7 trials, 2524 participants; low-certainty evidence). Participants treated with perampanel were more likely to withdraw from treatment due to adverse effects compared to those receiving placebo (RR 2.36, 95% CI 1.59 to 3.51; 7 trials, 2524 participants; low-certainty evidence). A higher proportion of participants receiving perampanel reported one or more adverse effects when compared to participants who received placebo (RR 1.17, 95% CI 1.10 to 1.24; 7 trials, 2524 participants; high-certainty evidence). Compared with placebo, participants receiving perampanel were more likely to experience ataxia (RR 14.32, 99% CI 1.09 to 188.31; 2 trials, 1098 participants; low-certainty evidence), dizziness (RR 2.87, 99% CI 1.45 to 5.70; 7 trials, 2524 participants; low-certainty evidence), and somnolence (RR 1.76, 99% CI 1.02 to 3.04; 7 trials, 2524 participants).\nSubgroup analysis indicated that a larger proportion of participants who received perampanel at a dose of 4 mg/day (RR 1.38, 95% CI 1.05 to 1.83; 2 trials, 710 participants), 8 mg/day (RR 1.83, 95% CI 1.51 to 2.22; 4 trials, 1227 participants), or 12 mg/day (RR 2.38, 95% CI 1.86 to 3.04; 3 trials, 869 participants) achieved a 50% or greater reduction in seizure frequency compared to placebo; however, treatment with perampanel 12 mg/day also increased treatment withdrawal (RR 1.77, 95% CI 1.31 to 2.40; 3 trials, 869 participants).\nAuthors' conclusions\nAdd-on perampanel is effective at reducing seizure frequency and may be effective at maintaining seizure freedom for people with drug-resistant focal epilepsy. Although perampanel was well-tolerated, there was a higher proportion of treatment withdrawals with perampanel compared with placebo. Subgroup analysis suggested that 8 mg/day and 12 mg/day are the most efficacious perampanel doses; however, the use of 12 mg/day would likely increase the number of treatment withdrawals.\nFuture research should focus on investigating the efficacy and tolerability of perampanel with longer-term follow-up, as well as exploring an optimal dose.\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": "Add-on perampanel is effective at reducing seizure frequency and may maintain seizure freedom for people with drug-resistant focal epilepsy. Perampanel is well-tolerated at doses of 8 mg/day or less."
}
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query-laysum | 5023 | [
{
"role": "user",
"content": "Abstract: Background\nKangaroo mother care (KMC), originally defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants.\nObjectives\nTo determine whether evidence is available to support the use of KMC in LBW infants as an alternative to conventional neonatal care before or after the initial period of stabilization with conventional care, and to assess beneficial and adverse effects.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group. This included searches in CENTRAL (Cochrane Central Register of Controlled Trials; 2016, Issue 6), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), LILACS (Latin American and Caribbean Health Science Information database), and POPLINE (Population Information Online) databases (all from inception to June 30, 2016), as well as the WHO (World Health Organization) Trial Registration Data Set (up to June 30, 2016). In addition, we searched the web page of the Kangaroo Foundation, conference and symposia proceedings on KMC, and Google Scholar.\nSelection criteria\nRandomized controlled trials comparing KMC versus conventional neonatal care, or early-onset KMC versus late-onset KMC, in LBW infants.\nData collection and analysis\nData collection and analysis were performed according to the methods of the Cochrane Neonatal Review Group.\nMain results\nTwenty-one studies, including 3042 infants, fulfilled inclusion criteria. Nineteen studies evaluated KMC in LBW infants after stabilization, one evaluated KMC in LBW infants before stabilization, and one compared early-onset KMC with late-onset KMC in relatively stable LBW infants. Sixteen studies evaluated intermittent KMC, and five evaluated continuous KMC.\nKMC versus conventional neonatal care: At discharge or 40 to 41 weeks' postmenstrual age, KMC was associated with a statistically significant reduction in the risk of mortality (risk ratio [RR] 0.60, 95% confidence interval [CI] 0.39 to 0.92; eight trials, 1736 infants), nosocomial infection/sepsis (RR 0.35, 95% CI 0.22 to 0.54; five trials, 1239 infants), and hypothermia (RR 0.28, 95% CI 0.16 to 0.49; nine trials, 989 infants; moderate-quality evidence). At latest follow-up, KMC was associated with a significantly decreased risk of mortality (RR 0.67, 95% CI 0.48 to 0.95; 12 trials, 2293 infants; moderate-quality evidence) and severe infection/sepsis (RR 0.50, 95% CI 0.36 to 0.69; eight trials, 1463 infants; moderate-quality evidence). Moreover, KMC was found to increase weight gain (mean difference [MD] 4.1 g/d, 95% CI 2.3 to 5.9; 11 trials, 1198 infants; moderate-quality evidence), length gain (MD 0.21 cm/week, 95% CI 0.03 to 0.38; three trials, 377 infants) and head circumference gain (MD 0.14 cm/week, 95% CI 0.06 to 0.22; four trials, 495 infants) at latest follow-up, exclusive breastfeeding at discharge or 40 to 41 weeks' postmenstrual age (RR 1.16, 95% CI 1.07 to 1.25; six studies, 1453 mothers) and at one to three months' follow-up (RR 1.20, 95% CI 1.01 to 1.43; five studies, 600 mothers), any (exclusive or partial) breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age (RR 1.20, 95% CI 1.07 to 1.34; 10 studies, 1696 mothers; moderate-quality evidence) and at one to three months' follow-up (RR 1.17, 95% CI 1.05 to 1.31; nine studies, 1394 mothers; low-quality evidence), and some measures of mother-infant attachment and home environment. No statistically significant differences were found between KMC infants and controls in Griffith quotients for psychomotor development at 12 months’ corrected age (low-quality evidence). Sensitivity analysis suggested that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect for main outcomes.\nEarly-onset KMC versus late-onset KMC in relatively stable infants: One trial compared early-onset continuous KMC (within 24 hours post birth) versus late-onset continuous KMC (after 24 hours post birth) in 73 relatively stable LBW infants. Investigators reported no significant differences between the two study groups in mortality, morbidity, severe infection, hypothermia, breastfeeding, and nutritional indicators. Early-onset KMC was associated with a statistically significant reduction in length of hospital stay (MD 0.9 days, 95% CI 0.6 to 1.2).\nAuthors' conclusions\nEvidence from this updated review supports the use of KMC in LBW infants as an alternative to conventional neonatal care, mainly in resource-limited settings. Further information is required concerning the effectiveness and safety of early-onset continuous KMC in unstabilized or relatively stabilized LBW infants, as well as long-term neurodevelopmental outcomes and costs of care.\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": "Conventional neonatal care of LBW infants (< 2500 g) is expensive and requires both highly skilled personnel and permanent logistical support. KMC has been proposed as an alternative to conventional neonatal care of LBW infants. The major component of KMC is skin-to-skin contact between mother and newborn. The other two components of KMC are frequent and exclusive or nearly exclusive breastfeeding and attempted early discharge from hospital."
}
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query-laysum | 5024 | [
{
"role": "user",
"content": "Abstract: Background\nVulval cancer is usually treated by wide local excision with removal of groin lymph nodes (inguinofemoral lymphadenectomy) from one or both sides, depending on the tumour location. However, this procedure is associated with significant morbidity. As lymph node metastasis occurs in about 30% of women with early vulval cancer, accurate prediction of lymph node metastases could reduce the extent of surgery in many women, thereby reducing morbidity. Sentinel node assessment is a diagnostic technique that uses traceable agents to identify the spread of cancer cells to the lymph nodes draining affected tissue. Once the sentinel nodes are identified, they are removed and submitted to histological examination. This technique has been found to be useful in diagnosing the nodal involvement of other types of tumours. Sentinel node assessment in vulval cancer has been evaluated with various tracing agents. It is unclear which tracing agent or combination of agents is most accurate.\nObjectives\nTo assess the diagnostic test accuracy of various techniques using traceable agents for sentinel lymph node assessment to diagnose groin lymph node metastasis in women with FIGO stage IB or higher vulval cancer and to investigate sources of heterogeneity.\nSearch methods\nWe searched MEDLINE (1946 to February 2013), EMBASE (1974 to March 2013) and the relevant Cochrane trial registers.\nSelection criteria\nStudies that evaluated the diagnostic accuracy of traceable agents for sentinel node assessment (involving the identification of a sentinel node plus histological examination) compared with histological examination of removed groin lymph nodes following complete inguinofemoral lymphadenectomy (IFL) in women with vulval cancer, provided there were sufficient data for the construction of two-by-two tables.\nData collection and analysis\nTwo authors (TAL, AP) independently screened titles and abstracts for relevance, classified studies for inclusion/exclusion and extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We used univariate meta-analytical methods to estimate pooled sensitivity estimates.\nMain results\nWe included 34 studies evaluating 1614 women and approximately 2396 groins. The overall methodological quality of included studies was moderate. The studies included in this review used the following traceable techniques to identify sentinel nodes in their participants: blue dye only (three studies), technetium only (eight studies), blue dye plus technetium combined (combined tests; 13 studies) and various inconsistent combinations of these three techniques (mixed tests; 10 studies). For studies of mixed tests, we obtained separate test data where possible.\nMost studies used haematoxylin and eosin (H&E) stains for the histological examination. Additionally an immunohistochemical (IHC) stain with and without ultrastaging was employed by 14 and eight studies, respectively. One study used reverse transcriptase polymerase chain reaction analysis (CA9 RT-PCR), whilst three studies did not describe the histological methods used.\nThe pooled sensitivity estimate for studies using blue dye only was 0.94 (68 women; 95% confidence interval (CI) 0.69 to 0.99), for mixed tests was 0.91 (679 women; 95% CI 0.71 to 0.98), for technetium only was 0.93 (149 women; 95% CI 0.89 to 0.96) and for combined tests was 0.95 (390 women; 95% CI 0.89 to 0.97). Negative predictive values (NPVs) for all index tests were > 95%. Most studies also reported sentinel node detection rates (the ability of the test to identify a sentinel node) of the index test. The mean detection rate for blue dye alone was 82%, compared with 95%, 96% and 98% for mixed tests, technetium only and combined tests, respectively. We estimated the clinical consequences of the various tests for 100 women undergoing the sentinel node procedure, assuming the prevalence of groin metastases to be 30%. For the combined or technetium only tests, one and two women with groin metastases might be 'missed', respectively (95% CI 1 to 3); and for mixed tests, three women with groin metastases might be 'missed' (95% CI 1 to 9). The wide CIs associated with the pooled sensitivity estimates for blue dye and mixed tests increased the potential for these tests to 'miss' women with groin metastases.\nAuthors' conclusions\nThere is little difference in diagnostic test accuracy between the technetium and combined tests. The combined test may reduce the number of women with 'missed' groin node metastases compared with technetium only. Blue dye alone may be associated with more 'missed' cases compared with tests using technetium. Sentinel node assessment with technetium-based tests will reduce the need for IFL by 70% in women with early vulval cancer. It is not yet clear how the survival of women with negative sentinel nodes compares to those undergoing standard surgery (IFL). A randomised controlled trial of sentinel node dissection and IFL has methodological and ethical issues, therefore more observational data on the survival of women with early vulval cancer are needed.\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": "The combined and technetium only tests are able to predict accurately which women have cancerous spread to the groin. For a group of 100 women undergoing assessment, the findings mean that approximately one or fewer women having the combined or technetium only tests will undergo an unnecessary IFL, compared with approximately 11 women having the blue dye only test. This is mainly because the blue dye only test is not as good as technetium in identifying sentinel nodes. Fewer women with spread to the groin will be missed with the combined or technetium only tests (1 to 3 out of 30) compared with the blue dye only test (1 to 8 out of 30). It is not clear whether women with negative sentinel nodes (i.e. no spread of cancer to the groin lymph nodes) who do not undergo IFL will live as long as those who undergo IFL. The current best data on survival come from a Dutch study that followed up 259 women with negative sentinel nodes and reported a three-year survival of 97%."
}
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query-laysum | 5025 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in The Cochrane Library 2008, Issue 3.\nUpper abdominal surgical procedures are associated with a high risk of postoperative pulmonary complications. The risk and severity of postoperative pulmonary complications can be reduced by the judicious use of therapeutic manoeuvres that increase lung volume. Our objective was to assess the effect of incentive spirometry compared to no therapy or physiotherapy, including coughing and deep breathing, on all-cause postoperative pulmonary complications and mortality in adult patients admitted to hospital for upper abdominal surgery.\nObjectives\nOur primary objective was to assess the effect of incentive spirometry (IS), compared to no such therapy or other therapy, on postoperative pulmonary complications and mortality in adults undergoing upper abdominal surgery.\nOur secondary objectives were to evaluate the effects of IS, compared to no therapy or other therapy, on other postoperative complications, adverse events, and spirometric parameters.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE, EMBASE, and LILACS (from inception to August 2013). There were no language restrictions. The date of the most recent search was 12 August 2013. The original search was performed in June 2006.\nSelection criteria\nWe included randomized controlled trials (RCTs) of IS in adult patients admitted for any type of upper abdominal surgery, including patients undergoing laparoscopic procedures.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data.\nMain results\nWe included 12 studies with a total of 1834 participants in this updated review. The methodological quality of the included studies was difficult to assess as it was poorly reported, so the predominant classification of bias was 'unclear'; the studies did not report on compliance with the prescribed therapy. We were able to include data from only 1160 patients in the meta-analysis. Four trials (152 patients) compared the effects of IS with no respiratory treatment. We found no statistically significant difference between the participants receiving IS and those who had no respiratory treatment for clinical complications (relative risk (RR) 0.59, 95% confidence interval (CI) 0.30 to 1.18). Two trials (194 patients) IS compared incentive spirometry with deep breathing exercises (DBE). We found no statistically significant differences between the participants receiving IS and those receiving DBE in the meta-analysis for respiratory failure (RR 0.67, 95% CI 0.04 to 10.50). Two trials (946 patients) compared IS with other chest physiotherapy. We found no statistically significant differences between the participants receiving IS compared to those receiving physiotherapy in the risk of developing a pulmonary condition or the type of complication. There was no evidence that IS is effective in the prevention of pulmonary complications.\nAuthors' conclusions\nThere is low quality evidence regarding the lack of effectiveness of incentive spirometry for prevention of postoperative pulmonary complications in patients after upper abdominal surgery. This review underlines the urgent need to conduct well-designed trials in this field. There is a case for large RCTs with high methodological rigour in order to define any benefit from the use of incentive spirometry regarding mortality.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Because of poorly conducted studies (results not similar across studies; some issues with study design and; not enough data collected and organized) we ranked the overall quality of the evidence reported in this review as low."
}
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query-laysum | 5026 | [
{
"role": "user",
"content": "Abstract: Background\nHaving nurses take on tasks that are typically conducted by doctors (doctor-nurse substitution, a form of 'task-shifting') may help to address doctor shortages and reduce doctors' workload and human resource costs. A Cochrane Review of effectiveness studies suggested that nurse-led care probably leads to similar healthcare outcomes as care delivered by doctors. This finding highlights the need to explore the factors that affect the implementation of strategies to substitute doctors with nurses in primary care. In our qualitative evidence synthesis (QES), we focused on studies of nurses taking on tasks that are typically conducted by doctors working in primary care, including substituting doctors with nurses or expanding nurses' roles.\nObjectives\n(1) To identify factors influencing implementation of interventions to substitute doctors with nurses in primary care. (2) To explore how our synthesis findings related to, and helped to explain, the findings of the Cochrane intervention review of the effectiveness of substituting doctors with nurses. (3) To identify hypotheses for subgroup analyses for future updates of the Cochrane intervention review.\nSearch methods\nWe searched CINAHL and PubMed, contacted experts in the field, scanned the reference lists of relevant studies and conducted forward citation searches for key articles in the Social Science Citation Index and Science Citation Index databases, and 'related article' searches in PubMed.\nSelection criteria\nWe constructed a maximum variation sample (exploring variables such as country level of development, aspects of care covered and the types of participants) from studies that had collected and analysed qualitative data related to the factors influencing implementation of doctor-nurse substitution and the expansion of nurses' tasks in community or primary care worldwide. We included perspectives of doctors, nurses, patients and their families/carers, policymakers, programme managers, other health workers and any others directly involved in or affected by the substitution. We excluded studies that collected data using qualitative methods but did not analyse the data qualitatively.\nData collection and analysis\nWe identified factors influencing implementation of doctor-nurse substitution strategies using a framework thematic synthesis approach. Two review authors independently assessed the methodological strengths and limitations of included studies using a modified Critical Appraisal Skills Programme (CASP) tool. We assessed confidence in the evidence for the QES findings using the GRADE-CERQual approach. We integrated our findings with the evidence from the effectiveness review of doctor-nurse substitution using a matrix model. Finally, we identified hypotheses for subgroup analyses for updates of the review of effectiveness.\nMain results\nWe included 66 studies (69 papers), 11 from low- or middle-income countries and 55 from high-income countries. These studies found several factors that appeared to influence the implementation of doctor-nurse substitution strategies. The following factors were based on findings that we assessed as moderate or high confidence.\nPatients in many studies knew little about nurses' roles and the difference between nurse-led and doctor-led care. They also had mixed views about the type of tasks that nurses should deliver. They preferred doctors when the tasks were more 'medical' but accepted nurses for preventive care and follow-ups. Doctors in most studies also preferred that nurses performed only 'non-medical' tasks. Nurses were comfortable with, and believed they were competent to deliver a wide range of tasks, but particularly emphasised tasks that were more health promotive/preventive in nature.\nPatients in most studies thought that nurses were more easily accessible than doctors. Doctors and nurses also saw nurse-doctor substitution and collaboration as a way of increasing people's access to care, and improving the quality and continuity of care.\nNurses thought that close doctor-nurse relationships and doctor's trust in and acceptance of nurses was important for shaping their roles. But nurses working alone sometimes found it difficult to communicate with doctors.\nNurses felt they had gained new skills when taking on new tasks. But nurses wanted more and better training. They thought this would increase their skills, job satisfaction and motivation, and would make them more independent.\nNurses taking on doctors' tasks saw this as an opportunity to develop personally, to gain more respect and to improve the quality of care they could offer to patients. Better working conditions and financial incentives also motivated nurses to take on new tasks. Doctors valued collaborating with nurses when this reduced their own workload.\nDoctors and nurses pointed to the importance of having access to resources, such as enough staff, equipment and supplies; good referral systems; experienced leaders; clear roles; and adequate training and supervision. But they often had problems with these issues. They also pointed to the huge number of documents they needed to complete when tasks were moved from doctors to nurses.\nAuthors' conclusions\nPatients, doctors and nurses may accept the use of nurses to deliver services that are usually delivered by doctors. But this is likely to depend on the type of services. Nurses taking on extra tasks want respect and collaboration from doctors; as well as proper resources; good referral systems; experienced leaders; clear roles; and adequate incentives, training and supervision. However, these needs are not always met.\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": "Many people do not get the healthcare they need because of a lack of healthcare workers where they live. Governments across the world are trying different solutions to address this problem. One possible solution is to move tasks from more-specialised to less-specialised health workers, for instance, moving certain tasks from doctors to nurses.\nIn this review, we looked for studies that explored how patients, nurses, doctors and others viewed and experienced these solutions, and what could influence their success."
}
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query-laysum | 5027 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.\nThis is an update of a Cochrane Review first published in 2003 and last published in 2013.\nObjectives\nTo assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.\nData collection and analysis\nTwo review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.\nMain results\nWe included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms.\nGenerally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials.\nPessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty).\nPessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls.\nPessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).\nAuthors' conclusions\nWe are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.\nThe review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.\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 four studies involving 478 women with various stages of prolapse. All four studies were carried out in high-income countries."
}
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query-laysum | 5028 | [
{
"role": "user",
"content": "Abstract: Background\nDisease-related malnutrition has been reported in 10% to 55% of people in hospital and the community and is associated with significant health and social-care costs. Dietary advice (DA) encouraging consumption of energy- and nutrient-rich foods rather than oral nutritional supplements (ONS) may be an initial treatment.\nObjectives\nTo examine evidence that DA with/without ONS in adults with disease-related malnutrition improves survival, weight, anthropometry and quality of life (QoL).\nSearch methods\nWe identified relevant publications from comprehensive electronic database searches and handsearching.\nLast search: 01 March 2021.\nSelection criteria\nRandomised controlled trials (RCTs) of DA with/without ONS in adults with disease-related malnutrition in any healthcare setting compared with no advice, ONS or DA alone.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, extracted data and graded evidence.\nMain results\nWe included 94, mostly parallel, RCTs (102 comparisons; 10,284 adults) across many conditions possibly explaining the high heterogeneity. Participants were mostly older people in hospital, residential care and the community, with limited reporting on their sex. Studies lasted from one month to 6.5 years.\nDA versus no advice - 24 RCTs (3523 participants)\nMost outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.87 (95% confidence interval (CI) 0.26 to 2.96), or at later time points. We had no three-month data, but advice may make little or no difference to hospitalisations, or days in hospital after four to six months and up to 12 months. A similar effect was seen for complications at up to three months, MD 0.00 (95% CI -0.32 to 0.32) and between four and six months. Advice may improve weight after three months, MD 0.97 kg (95% CI 0.06 to 1.87) continuing at four to six months and up to 12 months; and may result in a greater gain in fat-free mass (FFM) after 12 months, but not earlier. It may also improve global QoL at up to three months, MD 3.30 (95% CI 1.47 to 5.13), but not later.\nDA versus ONS - 12 RCTs (852 participants)\nAll outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.66 (95% CI 0.34 to 1.26), or at later time points. Either intervention may make little or no difference to hospitalisations at three months, RR 0.36 (95% CI 0.04 to 3.24), but ONS may reduce hospitalisations up to six months. There was little or no difference between groups in weight change at three months, MD -0.14 kg (95% CI -2.01 to 1.74), or between four to six months. Advice (one study) may lead to better global QoL scores but only after 12 months. No study reported days in hospital, complications or FFM.\nDA versus DA plus ONS - 22 RCTs (1286 participants)\nMost outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.92 (95% CI 0.47 to 1.80) or at later time points. At three months advice may lead to fewer hospitalisations, RR 1.70 (95% CI 1.04 to 2.77), but not at up to six months. There may be little or no effect on length of hospital stay at up to three months, MD -1.07 (95% CI -4.10 to 1.97). At three months DA plus ONS may lead to fewer complications, RR 0.75 (95% CI o.56 to 0.99); greater weight gain, MD 1.15 kg (95% CI 0.42 to 1.87); and better global QoL scores, MD 0.33 (95% CI 0.09 to 0.57), but this was not seen at other time points. There was no effect on FFM at three months.\nDA plus ONS if required versus no advice or ONS - 31 RCTs (3308 participants)\nEvidence was moderate- to low-certainty. There may be little or no effect on mortality at three months, RR 0.82 (95% CI 0.58 to 1.16) or at later time points. Similarly, little or no effect on hospitalisations at three months, RR 0.83 (95% CI 0.59 to 1.15), at four to six months and up to 12 months; on days in hospital at three months, MD -0.12 (95% CI -2.48 to 2.25) or for complications at any time point. At three months, advice plus ONS probably improve weight, MD 1.25 kg (95% CI 0.73 to 1.76) and may improve FFM, 0.82 (95% CI 0.35 to 1.29), but these effects were not seen later. There may be little or no effect of either intervention on global QoL scores at three months, but advice plus ONS may improve scores at up to 12 months.\nDA plus ONS versus no advice or ONS - 13 RCTs (1315 participants)\nEvidence was low- to very low-certainty. There may be little or no effect on mortality after three months, RR 0.91 (95% CI 0.55 to 1.52) or at later time points. No study reported hospitalisations and there may be little or no effect on days in hospital after three months, MD -1.81 (95% CI -3.65 to 0.04) or six months. Advice plus ONS may lead to fewer complications up to three months, MD 0.42 (95% CI 0.20 to 0.89) (one study). Interventions may make little or no difference to weight at three months, MD 1.08 kg (95% CI -0.17 to 2.33); however, advice plus ONS may improve weight at four to six months and up to 12 months. Interventions may make little or no difference in FFM or global QoL scores at any time point.\nAuthors' conclusions\nWe found no evidence of an effect of any intervention on mortality. There may be weight gain with DA and with DA plus ONS in the short term, but the benefits of DA when compared with ONS are uncertain. The size and direction of effect and the length of intervention and follow-up required for benefits to emerge were inconsistent for all other outcomes. There were too few data for many outcomes to allow meaningful conclusions. Studies focusing on both patient-centred and healthcare outcomes are needed to address the questions in this review.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is current to: 01 March 2021."
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query-laysum | 5029 | [
{
"role": "user",
"content": "Abstract: Background\nPlasmodium vivax is an important cause of malaria in many parts of Asia and South America, and parasite resistance to the standard treatment (chloroquine) is now high in some parts of Oceania. This review aims to assess the current treatment options in the light of increasing chloroquine resistance.\nObjectives\nTo compare artemisinin-based combination therapies (ACTs) with alternative antimalarial regimens for treating acute uncomplicated P. vivax malaria.\nSearch methods\nWe searched the Cochrane Infectious Disease Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; LILACS; and the metaRegister of Controlled Trials (mRCT) up to 28 March 2013 using “vivax” and “arte* OR dihydroarte*” as search terms.\nSelection criteria\nRandomized controlled trials comparing ACTs versus standard therapy, or comparing alternative ACTs, in adults and children with uncomplicated P. vivax malaria.\nData collection and analysis\nTwo authors independently assessed trials for eligibility and risk of bias, and extracted data. We used recurrent parasitaemia prior to day 28 as a proxy for effective treatment of the blood stage parasite, and compared drug treatments using risk ratios (RR) and 95% confidence intervals (CIs). We used trials following patients for longer than 28 days to assess the duration of the post-treatment prophylactic effect of ACTs. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included 14 trials, that enrolled 2592 participants, and were all conducted in Asia and Oceania between 2002 and 2011.\nACTs versus chloroquine\nACTs clear parasites from the peripheral blood quicker than chloroquine monotherapy (parasitaemia after 24 hours of treatment: RR 0.42, 95% CI 0.36 to 0.50, four trials, 1652 participants, high quality evidence).\nIn settings where chloroquine remains effective, ACTs are as effective as chloroquine at preventing recurrent parasitaemias before day 28 (RR 0.58, 95% CI 0.18 to 1.90, five trials, 1622 participants, high quality evidence). In four of these trials, recurrent parasitaemias before day 28 were very low following treatment with both chloroquine and ACTs. The fifth trial, from Thailand in 2011, found increased recurrent parasitaemias following treatment with chloroquine (9%), while they remained low following ACT (2%) (RR 0.25, 95% CI 0.09 to 0.66, one trial, 437 participants).\nACT combinations with long half-lives probably also provide a longer prophylactic effect after treatment, with significantly fewer recurrent parasitaemias between day 28 and day 42 or day 63 (RR 0.57, 95% CI 0.40 to 0.82, three trials, 1066 participants, moderate quality evidence). One trial, from Cambodia, Thailand, India and Indonesia, gave additional primaquine to both treatment groups to reduce the risk of spontaneous relapses. Recurrent parasitaemias after day 28 were lower than seen in the trials that did not give primaquine, but the ACT still appeared to have an advantage (RR 0.27, 95% CI 0.08 to 0.94, one trial, 376 participants, low quality evidence).\nACTs versus alternative ACTs\nIn high transmission settings, dihydroartemisinin-piperaquine is probably superior to artemether-lumefantrine, artesunate plus sulphadoxine-pyrimethamine and artesunate plus amodiaquine at preventing recurrent parasitaemias before day 28 (RR 0.20, 95% CI 0.08 to 0.49, three trials, 334 participants, moderate quality evidence).\nDihydroartemisinin-piperaquine may also have an improved post-treatment prophylactic effect lasting for up to six weeks, and this effect may be present even when primaquine is also given to achieve radical cure (RR 0.21, 95% CI 0.10 to 0.46, two trials, 179 participants, low quality evidence).\nThe data available from low transmission settings is too limited to reliably assess the relative effectiveness of ACTs.\nAuthors' conclusions\nACTs appear at least equivalent to chloroquine at effectively treating the blood stage of P. vivax infection. Even in areas where chloroquine remains effective, this finding may allow for simplified protocols for treating all forms of malaria with ACTs. In areas where chloroquine no longer cures the infection, ACTs offer an effective alternative.\nDihydroartemisinin-piperaquine is the most studied ACT. It may provide a longer period of post-treatment prophylaxis than artemether-lumefantrine or artesunate plus amodiaquine. This effect may be clinically important in high transmission settings whether primaquine is also given or not.\n\nGiven the provided abstract, please respond to the following query: \"What is P. vivax malaria and how do ACTs work?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "P. vivaxmalaria and how do ACTs work?\nP. vivax is one of five species of the malaria parasite known to cause clinical illness. It is a common cause of malaria in Asia, South America and Oceania. Unlike P. falciparum (the commonest cause of malaria in Africa), P. vivax has a liver stage which is not treated by most common antimalarial drugs. This liver stage can become active and cause a relapse of clinical illness weeks or even years after the initial illness.\nThe standard treatment for vivax malaria has been chloroquine to treat the clinical illness, and a 14-day course of primaquine to clear the liver stage. In some parts of Oceania the P. vivax parasite in now highly resistant to chloroquine, which makes this treatment ineffective.\nArtemisinin-based combination therapies (ACTs) are now the recommended treatment for P. falciparum malaria worldwide. As the effectiveness of chloroquine for P. vivax declines, alternative therapies are needed. If ACTs are also effective against P. vivax they could become the standard treatment for all forms of malaria.\nCurrent ACT combinations do not contain drugs effective against the liver stage of P. vivax so primaquine would still be necessary to achieve complete cure."
}
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query-laysum | 5030 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with chronic heart failure (HF) are at risk of thromboembolic events, including stroke, pulmonary embolism, and peripheral arterial embolism; coronary ischaemic events also contribute to the progression of HF. The use of long-term oral anticoagulation is established in certain populations, including people with HF and atrial fibrillation (AF), but there is wide variation in the indications and use of oral anticoagulation in the broader HF population.\nObjectives\nTo determine whether long-term oral anticoagulation reduces total deaths and stroke in people with heart failure in sinus rhythm.\nSearch methods\nWe updated the searches in CENTRAL, MEDLINE, and Embase in March 2020. We screened reference lists of papers and abstracts from national and international cardiovascular meetings to identify unpublished studies. We contacted relevant authors to obtain further data. We did not apply any language restrictions.\nSelection criteria\nRandomised controlled trials (RCT) comparing oral anticoagulants with placebo or no treatment in adults with HF, with treatment duration of at least one month. We made inclusion decisions in duplicate, and resolved any disagreements between review authors by discussion, or a third party.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, and assessed the risks and benefits of antithrombotic therapy by calculating odds ratio (OR), accompanied by the 95% confidence intervals (CI).\nMain results\nWe identified three RCTs (5498 participants). One RCT compared warfarin, aspirin, and no antithrombotic therapy, the second compared warfarin with placebo in participants with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease.\nWe pooled data from the studies that compared warfarin with a placebo or no treatment. We are uncertain if there is an effect on all-cause death (OR 0.66, 95% CI 0.36 to 1.18; 2 studies, 324 participants; low-certainty evidence); warfarin may increase the risk of major bleeding events (OR 5.98, 95% CI 1.71 to 20.93; number needed to treat for an additional harmful outcome (NNTH) 17; 2 studies, 324 participants; low-certainty evidence). None of the studies reported stroke as an individual outcome.\nRivaroxaban makes little to no difference to all-cause death compared with placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, 5022 participants; high-certainty evidence). Rivaroxaban probably reduces the risk of stroke compared to placebo (OR 0.67, 95% CI 0.47 to 0.95; number needed to treat for an additional beneficial outcome (NNTB) 101; 1 study, 5022 participants; moderate-certainty evidence), and probably increases the risk of major bleeding events (OR 1.65, 95% CI 1.17 to 2.33; NNTH 79; 1 study, 5008 participants; moderate-certainty evidence).\nAuthors' conclusions\nBased on the three RCTs, there is no evidence that oral anticoagulant therapy modifies mortality in people with HF in sinus rhythm. The evidence is uncertain if warfarin has any effect on all-cause death compared to placebo or no treatment, but it may increase the risk of major bleeding events. There is no evidence of a difference in the effect of rivaroxaban on all-cause death compared to placebo. It probably reduces the risk of stroke, but probably increases the risk of major bleedings.\nThe available evidence does not support the routine use of anticoagulation in people with HF who remain in sinus rhythm.\n\nGiven the provided abstract, please respond to the following query: \"Why is the question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There are strong blood-thinning medications, called anticoagulants, which are successfully used in people with different clotting problems, such as those with HF who also have irregular heart beats (an arrhythmia called atrial fibrillation). At present, there are no data to recommend the use of anticoagulants to avoid clotting problems in people with HF who have regular heart beats (know as sinus rhythm). In this analysis, we assessed studies that tested anticoagulants in these people to avoid death, death from heart problems, and other severe clotting problems."
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query-laysum | 5031 | [
{
"role": "user",
"content": "Abstract: Background\nCentral venous catheters (CVC) are associated with potentially dangerous complications such as thromboses, pericardial effusions, extravasation, and infections in neonates. Indwelling catheters are amongst the main risk factors for nosocomial infections. The use of skin antiseptics during the preparation for central catheter insertion may prevent catheter-related bloodstream infections (CRBSI) and central line-associated bloodstream infections (CLABSI). However, it is still not clear which antiseptic solution is the best to prevent infection with minimal side effects.\nObjectives\nTo systematically evaluate the safety and efficacy of different antiseptic solutions in preventing CRBSI and other related outcomes in neonates with CVC.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and trial registries up to 22 April 2022. We checked reference lists of included trials and systematic reviews that related to the intervention or population examined in this Cochrane Review.\nSelection criteria\nRandomised controlled trials (RCTs) or cluster-RCTs were eligible for inclusion in this review if they were performed in the neonatal intensive care unit (NICU), and were comparing any antiseptic solution (single or in combination) against any other type of antiseptic solution or no antiseptic solution or placebo in preparation for central catheter insertion. We excluded cross-over trials and quasi-RCTs.\nData collection and analysis\nWe used the standard methods from Cochrane Neonatal. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included three trials that had two different comparisons: 2% chlorhexidine in 70% isopropyl alcohol (CHG-IPA) versus 10% povidone-iodine (PI) (two trials); and CHG-IPA versus 2% chlorhexidine in aqueous solution (CHG-A) (one trial). A total of 466 neonates from level III NICUs were evaluated. All included trials were at high risk of bias. The certainty of the evidence for the primary and some important secondary outcomes ranged from very low to moderate. There were no included trials that compared antiseptic skin solutions with no antiseptic solution or placebo.\nCHG-IPA versus 10% PI\nCompared to PI, CHG-IPA may result in little to no difference in CRBSI (risk ratio (RR) 1.32, 95% confidence interval (CI) 0.53 to 3.25; risk difference (RD) 0.01, 95% CI −0.03 to 0.06; 352 infants, 2 trials, low-certainty evidence) and all-cause mortality (RR 0.88, 95% CI 0.46 to 1.68; RD −0.01, 95% CI −0.08 to 0.06; 304 infants, 1 trial, low-certainty evidence). The evidence is very uncertain about the effect of CHG-IPA on CLABSI (RR 1.00, 95% CI 0.07 to 15.08; RD 0.00, 95% CI −0.11 to 0.11; 48 infants, 1 trial; very low-certainty evidence) and chemical burns (RR 1.04, 95% CI 0.24 to 4.48; RD 0.00, 95% CI −0.03 to 0.03; 352 infants, 2 trials, very low-certainty evidence), compared to PI. Based on a single trial, infants receiving CHG-IPA appeared less likely to develop thyroid dysfunction compared to PI (RR 0.05, 95% CI 0.00 to 0.85; RD −0.06, 95% CI −0.10 to −0.02; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 10 to 50; 304 infants). Neither of the two included trials assessed the outcome of premature central line removal or the proportion of infants or catheters with exit-site infection.\nCHG-IPA versus CHG-A\nThe evidence suggests CHG-IPA may result in little to no difference in the rate of proven CRBSI when applied on the skin of neonates prior to central line insertion (RR 0.80, 95% CI 0.34 to 1.87; RD −0.05, 95% CI −0.22 to 0.13; 106 infants, 1 trial, low-certainty evidence) and CLABSI (RR 1.14, 95% CI 0.34 to 3.84; RD 0.02, 95% CI −0.12 to 0.15; 106 infants, 1 trial, low-certainty evidence), compared to CHG-A. Compared to CHG-A, CHG-IPA probably results in little to no difference in premature catheter removal (RR 0.91, 95% CI 0.26 to 3.19; RD −0.01, 95% CI −0.15 to 0.13; 106 infants, 1 trial, moderate-certainty evidence) and chemical burns (RR 0.98, 95% CI 0.47 to 2.03; RD −0.01, 95% CI −0.20 to 0.18; 114 infants, 1 trial, moderate-certainty evidence). No trial assessed the outcome of all-cause mortality and the proportion of infants or catheters with exit-site infection.\nAuthors' conclusions\nBased on current evidence, compared to PI, CHG-IPA may result in little to no difference in CRBSI and mortality. The evidence is very uncertain about the effect of CHG-IPA on CLABSI and chemical burns. One trial showed a statistically significant increase in thyroid dysfunction with the use of PI compared to CHG-IPA.\nThe evidence suggests CHG-IPA may result in little to no difference in the rate of proven CRBSI and CLABSI when applied on the skin of neonates prior to central line insertion. Compared to CHG-A, CHG-IPA probably results in little to no difference in chemical burns and premature catheter removal.\nFurther trials that compare different antiseptic solutions are required, especially in low- and middle-income countries, before stronger conclusions can be made.\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 trials that compared:\n• different types of antiseptic solutions; or\n• different concentrations of the same antiseptic solution.\nWe compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 5032 | [
{
"role": "user",
"content": "Abstract: Background\nDupuytren's disease is a benign fibroproliferative disorder that causes the fingers to be drawn into the palm via formation of new tissue under the glabrous skin of the hand. This disorder causes functional limitations, but it can be treated through a variety of surgical techniques. As a chronic condition, it tends to recur.\nObjectives\nTo assess the benefits and harms of different surgical procedures for treatment of Dupuytren's contracture of the index, middle, ring and little fingers.\nSearch methods\nWe initially searched the following databases on 17 September 2012, then re-searched them on 10 March 2014 and on 20 May 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, the British Nursing Index and Archive (BNI), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, the Latin American Caribbean Health Sciences Literature (LILACS), Ovid MEDLINE, Ovid MEDLINE-In-Process and Other Non-Indexed Citations, ProQuest (ABI/INFORM Global and Dissertations & Theses), the Institute for Scientific Information (ISI) Web of Science and clinicaltrials.gov. We reviewed the reference lists of short-listed articles to identify additional suitable studies.\nSelection criteria\nWe included randomised clinical trials and controlled clinical trials in which groups received surgical intervention for Dupuytren's disease of the index, middle, ring or little finger versus control, or versus another intervention (surgical or otherwise). We excluded the thumb, as cords form on the radial aspect of the thumb and thus are not readily accessible in terms of angular deformity. Furthermore, thumb disease is rare.\nData collection and analysis\nA minimum of two review authors independently reviewed search results to select studies for inclusion by using pre-specified criteria, assessed risk of bias of included studies and extracted data from included studies.\nWe grouped outcomes into the following categories: (1) hand function, (2) other patient-reported outcomes (e.g. satisfaction, pain), (3) early objective outcomes (e.g. correction of angular deformity), (4) late objective outcomes (e.g. recurrence) and (5) adverse effects.\nMain results\nWe included 14 articles describing 13 studies, comprising 11 single-centre studies and two multi-centre studies. These studies involved 944 hands of 940 participants; of these, 93 participants were reported twice in separate articles describing early and late outcomes of one trial. Three papers reported the outcomes of two trials comparing different procedures. One trial compared needle fasciotomy versus fasciectomy (125 hands, 121 participants), and the other compared interposition firebreak skin grafting versus z-plasty closure of fasciectomy (79 participants). The other 11 studies reported trials of technical refinements of procedures or rehabilitation adjuncts. Of these, three investigated effects of postoperative splinting on surgical outcomes.\nTen studies (11 articles) were randomised controlled trials (RCTs) of varying methodological quality; one was a controlled clinical trial. Trial design was unclear in two studies awaiting classification. All trials had high or unclear risk of at least one type of bias. High risks of performance and detection bias were particularly common. We downgraded the quality of evidence (Grades of Recommendation, Assessment, Development and Evaluation - GRADE) of outcomes to low because of concerns about risk of bias and imprecision.\nOutcomes measured varied between studies. Five articles assessed recurrence; two defined this as reappearance of palpable disease and two as deterioration in angular deformity; one did not explicitly define recurrence.\nHand function on the Disabilities of the Arm, Shoulder and Hand (DASH) Scale (scores between 0 and 100, with higher scores indicating greater impairment) was 5 points lower after needle fasciotomy than after fasciectomy at five weeks. Patient satisfaction was better after fasciotomy at six weeks, but the magnitude of effect was not specified. Fasciectomy improved contractures more effectively in severe disease: Mean percentage reduction in total passive extension deficit at six weeks for Tubiana grades I and II was 11% lower after needle fasciotomy than after fasciectomy, whereas for grades III and IV disease, it was 29% and 32% lower.\nParaesthesia (defined as subjective tingling sensation without objective evidence of altered sensation) was more common than needle fasciotomy at one week after fasciectomy (228/1000 vs 67/1000), but reporting of complications was variable.\nBy five years, satisfaction (on a scale from 0 to 10, with higher scores showing greater satisfaction) was 2.1/10 points higher in the fasciectomy group than in the fasciotomy group, and recurrence was greater after fasciotomy (849/1000 vs 209/1000). Firebreak skin grafting did not improve outcomes more than fasciectomy alone, although this procedure took longer to perform.\nOne trial investigated four weeks of day and night splinting followed by two months of night splinting after surgery. The other two trials investigated three months of night splinting after surgery, but participants in 'no splint' groups with early deterioration at one week were issued a splint for use. All three studies demonstrated no benefit from splinting. The two trials investigating postoperative night splinting were suitable for meta-analysis, which demonstrated no benefit from splinting: Mean DASH score in the splint groups was 1.15 points lower (95% confidence interval (CI) -2.32 to 4.62) than in the no splint groups. Mean total active extension in the splint groups was 2.21 degrees greater (95% CI -3.59 to 8.01 degrees) than in the no splint groups. Mean total active flexion in the splint groups was 8.42 degrees less (95% CI 1.78 to 15.07 degrees) than in the no splint groups.\nAuthors' conclusions\nCurrently, insufficient evidence is available to show the relative superiority of different surgical procedures (needle fasciotomy vs fasciectomy, or interposition firebreak skin grafting vs z-plasty closure of fasciectomy). Low-quality evidence suggests that postoperative splinting may not improve outcomes and may impair outcomes by reducing active flexion. Further trials on this topic are urgently required.\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": "Dupuytren's disease is common. Patients develop scar-like tissue under the palmar skin of the hand that draws their fingers into the palm and can affect function.\nThis condition can be surgically treated by cutting out the disease, then stitching the skin back into place (fasciectomy) or replacing it with a graft of skin taken from elsewhere on the body (dermofasciectomy). Alternative approaches involve breaking the cord of disease to straighten the finger. This can be done by moving a needle back and forth through the cord until it snaps, as when rubbing a rope repeatedly over a rock (needle fasciotomy), or by injecting into it an enzyme that digests a piece of the cord (collagenase). This weakens one spot, allowing the surgeon to snap the cord and straighten the finger. As the condition is related in part to genetics, it tends to come back, even after successful treatment. As the latter two treatments leave the broken ends of the cord behind, recurrence may be quicker after these procedures than after traditional excisional surgery. However, recovery might also be quicker. The most effective treatment is unclear."
}
]
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query-laysum | 5033 | [
{
"role": "user",
"content": "Abstract: Background\nOutpatient care facilities provide a variety of basic healthcare services to individuals who do not require hospitalisation or institutionalisation, and are usually the patient's first contact. The provision of outpatient care contributes to immediate and large gains in health status, and a large portion of total health expenditure goes to outpatient healthcare services. Payment method is one of the most important incentive methods applied by purchasers to guide the performance of outpatient care providers.\nObjectives\nTo assess the impact of different payment methods on the performance of outpatient care facilities and to analyse the differences in impact of payment methods in different settings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), 2016, Issue 3, part of the Cochrane Library (searched 8 March 2016); MEDLINE, OvidSP (searched 8 March 2016); Embase, OvidSP (searched 24 April 2014); PubMed (NCBI) (searched 8 March 2016); Dissertations and Theses Database, ProQuest (searched 8 March 2016); Conference Proceedings Citation Index (ISI Web of Science) (searched 8 March 2016); IDEAS (searched 8 March 2016); EconLit, ProQuest (searched 8 March 2016); POPLINE, K4Health (searched 8 March 2016); China National Knowledge Infrastructure (searched 8 March 2016); Chinese Medicine Premier (searched 8 March 2016); OpenGrey (searched 8 March 2016); ClinicalTrials.gov, US National Institutes of Health (NIH) (searched 8 March 2016); World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 8 March 2016); and the website of the World Bank (searched 8 March 2016).\nIn addition, we searched the reference lists of included studies and carried out a citation search for the included studies via ISI Web of Science to find other potentially relevant studies. We also contacted authors of the main included studies regarding any further published or unpublished work.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies that compared different payment methods for outpatient health facilities. We defined outpatient care facilities in this review as facilities that provide health services to individuals who do not require hospitalisation or institutionalisation. We only included methods used to transfer funds from the purchaser of healthcare services to health facilities (including groups of individual professionals). These include global budgets, line-item budgets, capitation, fee-for-service (fixed and unconstrained), pay for performance, and mixed payment. The primary outcomes were service provision outcomes, patient outcomes, healthcare provider outcomes, costs for providers, and any adverse effects.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the risk of bias. We conducted a structured synthesis. We first categorised the comparisons and outcomes and then described the effects of different types of payment methods on different categories of outcomes. We used a fixed-effect model for meta-analysis within a study if a study included more than one indicator in the same category of outcomes. We used a random-effects model for meta-analysis across studies. If the data for meta-analysis were not available in some studies, we calculated the median and interquartile range. We reported the risk ratio (RR) for dichotomous outcomes and the relative change for continuous outcomes.\nMain results\nWe included 21 studies from Afghanistan, Burundi, China, Democratic Republic of Congo, Rwanda, Tanzania, the United Kingdom, and the United States of health facilities providing primary health care and mental health care. There were three kinds of payment comparisons.\n1) Pay for performance (P4P) combined with some existing payment method (capitation or different kinds of input-based payment) compared to the existing payment method\nWe included 18 studies in this comparison, however we did not include five studies in the effects analysis due to high risk of bias. From the 13 studies, we found that the extra P4P incentives probably slightly improved the health professionals' use of some tests and treatments (adjusted RR median = 1.095, range 1.01 to 1.17; moderate-certainty evidence), and probably led to little or no difference in adherence to quality assurance criteria (adjusted percentage change median = -1.345%, range -8.49% to 5.8%; moderate-certainty evidence). We also found that P4P incentives may have led to little or no difference in patients' utilisation of health services (adjusted RR median = 1.01, range 0.96 to 1.15; low-certainty evidence) and may have led to little or no difference in the control of blood pressure or cholesterol (adjusted RR = 1.01, range 0.98 to 1.04; low-certainty evidence).\n2) Capitation combined with P4P compared to fee-for-service (FFS)\nOne study found that compared with FFS, a capitated budget combined with payment based on providers' performance on antibiotic prescriptions and patient satisfaction probably slightly reduced antibiotic prescriptions in primary health facilities (adjusted RR 0.84, 95% confidence interval 0.74 to 0.96; moderate-certainty evidence).\n3) Capitation compared to FFS\nTwo studies compared capitation to FFS in mental health centres in the United States. Based on these studies, the effects of capitation compared to FFS on the utilisation and costs of services were uncertain (very low-certainty evidence).\nAuthors' conclusions\nOur review found that if policymakers intend to apply P4P incentives to pay health facilities providing outpatient services, this intervention will probably lead to a slight improvement in health professionals' use of tests or treatments, particularly for chronic diseases. However, it may lead to little or no improvement in patients' utilisation of health services or health outcomes. When considering using P4P to improve the performance of health facilities, policymakers should carefully consider each component of their P4P design, including the choice of performance measures, the performance target, payment frequency, if there will be additional funding, whether the payment level is sufficient to change the behaviours of health providers, and whether the payment to facilities will be allocated to individual professionals. Unfortunately, the studies included in this review did not help to inform those considerations.\nWell-designed comparisons of different payment methods for outpatient health facilities in low- and middle-income countries and studies directly comparing different designs (e.g. different payment levels) of the same payment method (e.g. P4P or FFS) are needed.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that had been published up to March 2016."
}
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query-laysum | 5034 | [
{
"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: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up-to-date to 7 December 2021."
}
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query-laysum | 5035 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding without an organic lesion is mainly due to an imbalance of the various hormones which have a regulatory effect on the menstrual cycle. Another cause of heavy menstrual bleeding with no pelvic pathology, is the presence of an acquired or inherited bleeding disorder. The haemostatic system has a central role in controlling the amount and the duration of menstrual bleeding, thus abnormally prolonged or profuse bleeding does occur in most women affected by bleeding disorders. Whereas irregular, pre-menarchal or post-menopausal uterine bleeding is unusual in inherited or acquired haemorrhagic disorders, severe acute bleeding and heavy menstrual bleeding at menarche and chronic heavy menstrual bleeding during the entire reproductive life are common. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine the efficacy and safety of non-surgical interventions versus each other, placebo or no treatment for reducing menstrual blood loss in women with bleeding disorders.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Haemoglobinopathies Trials Register (25 August 2016), Embase (May 2013), LILACS (February 2013) and the WHO International Clinical Trial registry (February 2013).\nSelection criteria\nRandomised controlled studies of non-surgical interventions for treating heavy menstrual bleeding (menorrhagia) in women of reproductive age suffering from a congenital or acquired bleeding disorder.\nData collection and analysis\nTwo authors independently assessed studies for inclusion, extracted data and assessed the risk of bias.\nMain results\nThree cross-over studies, with 175 women were included in the review. All three studies had an unclear risk of bias with regards to trial design and overall, the quality of evidence generated was judged to be poor.\nTwo of the studies (n = 59) compared desmopressin (1-deamino-8-D-arginine vasopressin) with placebo. Menstrual blood loss was the primary outcome for both of these studies. Neither study found clear evidence of a difference between groups. The first of these reported a mean difference in menstrual blood loss in the desmopressin versus placebo group of 21.20 mL (95% confidence interval -19.00 to 61.50)\nThe second study reported that even though there was an improvement of pictorial bleeding assessment chart scores with desmopressin and placebo when compared to pretreatment assessment, there was no clear evidence of difference in these scores when the two were compared to each other (results presented graphically, P = 0.51). The data from these studies could not be combined.\nThe third study (n = 116) compared desmopressin with tranexamic acid (n = 116). This study found a decrease in pictorial bleeding assessment chart scores after both treatments as compared to baseline. The decrease in these scores was greater for tranexamic acid than for desmopressin, with a mean difference of 41.6 mL (95% confidence interval 19.6 to 63) (P < 0.0002).\nIn relation to adverse events, across two studies, there was no clear evidence of a difference when placebo was compared to desmopressin, risk ratio 1.17 (95% confidence interval 0.41 to 3.34) . The same was also true when desmopressin was compared to tranexamic acid, risk ratio 1.17 (95% confidence interval 0.41 to 3.34).\nOnly the study that compared desmopressin to tranexamic acid assessed quality of life. However, we are unable to present any data from this study, since no differences in this outcome between the two intervention groups were reported.\nAuthors' conclusions\nEvidence from randomised controlled studies on the effect of desmopressin when compared to placebo in reducing menstrual blood loss is very limited and inconclusive. Two studies, each with a very limited number of participants, have shown uncertain effects in menstrual blood loss and adverse effects. A non-randomised comparison in one of the studies points to the value of combining desmopressin and tranexamic acid, which needs to be tested in a formal randomised controlled study comparison.\nWhen tranexamic acid was compared to desmopressin, a single study showed a reduction in menstrual blood loss with tranexamic acid use compared to desmopressin.\nThere is a need to evaluate non-surgical methods for treating of menorrhagia in women with bleeding disorders through randomised controlled studies. Such methods would be more acceptable than surgery for women wishing to retain their fertility. Given that women may need to use these treatments throughout their entire reproductive life, long-term side-effects should be evaluated.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We were not able to adequately assess the studies in relation to how the women were allocated to the treatment groups and we judged the overall quality of the evidence as poor."
}
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query-laysum | 5036 | [
{
"role": "user",
"content": "Abstract: Background\nPoor nutrition occurs frequently in people with cystic fibrosis and is associated with other adverse outcomes. Oral calorie supplements are used to increase total daily calorie intake and improve weight gain. However, they are expensive and there are concerns they may reduce the amount of food eaten and not improve overall energy intake. This is an update of a previously published review.\nObjectives\nTo establish whether in people with cystic fibrosis, oral calorie supplements: increase daily calorie intake; and improve overall nutritional intake, nutritional indices, lung function, survival and quality of life. To assess adverse effects associated with using these supplements.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register comprising references from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We contacted companies marketing oral calorie supplements.\nLast search: 18 October 2016.\nSelection criteria\nRandomised or quasi-randomised controlled trials comparing use of oral calorie supplements for at least one month to increase calorie intake with no specific intervention or additional nutritional advice in people with cystic fibrosis.\nData collection and analysis\nWe independently selected the included trials, assessed risk of bias and extracted data. We contacted the authors of included trials and obtained additional information for two trials.\nMain results\nWe identified 21 trials and included three, reporting results from 131 participants lasting between three months and one year. Two trials compared supplements to additional nutritional advice and one to no intervention. Two of the included trials recruited only children. In one trial the risk of bias was low across all domains, in a second trial the risk of bias was largely unclear and in the third mainly low. Blinding of participants was unclear in two of the trials. Also, in one trial the clinical condition of groups appeared to be unevenly balanced at baseline and in another trial there were concerns surrounding allocation concealment. There were no significant differences between people receiving supplements or dietary advice alone for change in weight, height, body mass index, z score or other indices of nutrition or growth. Changes in weight (kg) at three, six and 12 months respectively were: mean difference (MD) 0.32 (95% confidence interval (CI) -0.09 to 0.72); MD 0.47 (95% CI -0.07 to 1.02 ); and MD 0.16 (-0.68 to 1.00). Total calorie intake was greater in people taking supplements at 12 months, MD 265.70 (95% CI 42.94 to 488.46). There were no significant differences between the groups for anthropometric measures of body composition, lung function, gastro-intestinal adverse effects or activity levels. Moderate quality evidence exists for the outcomes of changes in weight and height and low quality evidence exists for the outcomes of change in total calories, total fat and total protein intake as results are applicable only to children between the ages of 2 and 15 years and many post-treatment diet diaries were not returned. Evidence for the rate of adverse events in the treatment groups was extremely limited and judged to be of very low quality\nAuthors' conclusions\nOral calorie supplements do not confer any additional benefit in the nutritional management of moderately malnourished children with cystic fibrosis over and above the use of dietary advice and monitoring alone. While nutritional supplements may be used, they should not be regarded as essential. Further randomised controlled trials are needed to establish the role of short-term oral protein energy supplements in people with cystic fibrosis and acute weight loss and also for the long-term nutritional management of adults with cystic fibrosis or advanced lung disease, or both.\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 last searched for evidence on 18 October 2016."
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query-laysum | 5037 | [
{
"role": "user",
"content": "Abstract: Background\nVitamins and minerals are essential for growth and maintenance of a healthy body, and have a role in the functioning of almost every organ. Multiple interventions have been designed to improve micronutrient deficiency, and food fortification is one of them.\nObjectives\nTo assess the impact of food fortification with multiple micronutrients on health outcomes in the general population, including men, women and children.\nSearch methods\nWe searched electronic databases up to 29 August 2018, including the Cochrane Central Register of Controlled Trial (CENTRAL), the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register and Cochrane Public Health Specialised Register; MEDLINE; Embase, and 20 other databases, including clinical trial registries. There were no date or language restrictions. We checked reference lists of included studies and relevant systematic reviews for additional papers to be considered for inclusion.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs, quasi-randomised trials, controlled before-after (CBA) studies and interrupted time series (ITS) studies that assessed the impact of food fortification with multiple micronutrients (MMNs). Primary outcomes included anaemia, micronutrient deficiencies, anthropometric measures, morbidity, all-cause mortality and cause-specific mortality. Secondary outcomes included potential adverse outcomes, serum concentration of specific micronutrients, serum haemoglobin levels and neurodevelopmental and cognitive outcomes. We included food fortification studies from both high-income and low- and middle-income countries (LMICs).\nData collection and analysis\nTwo review authors independently screened, extracted and quality-appraised the data from eligible studies. We carried out statistical analysis using Review Manager 5 software. We used random-effects meta-analysis for combining data, as the characteristics of study participants and interventions differed significantly. We set out the main findings of the review in 'Summary of findings' tables, using the GRADE approach.\nMain results\nWe identified 127 studies as relevant through title/abstract screening, and included 43 studies (48 papers) with 19,585 participants (17,878 children) in the review. All the included studies except three compared MMN fortification with placebo/no intervention. Two studies compared MMN fortification versus iodised salt and one study compared MMN fortification versus calcium fortification alone. Thirty-six studies targeted children; 20 studies were conducted in LMICs. Food vehicles used included staple foods, such as rice and flour; dairy products, including milk and yogurt; non-dairy beverages; biscuits; spreads; and salt. Fourteen of the studies were fully commercially funded, 13 had partial-commercial funding, 14 had non-commercial funding and two studies did not specify the source of funding. We rated all the evidence as of low to very low quality due to study limitations, imprecision, high heterogeneity and small sample size.\nWhen compared with placebo/no intervention, MMN fortification may reduce anaemia by 32% (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.56 to 0.84; 11 studies, 3746 participants; low-quality evidence), iron deficiency anaemia by 72% (RR 0.28, 95% CI 0.19 to 0.39; 6 studies, 2189 participants; low-quality evidence), iron deficiency by 56% (RR 0.44, 95% CI 0.32 to 0.60; 11 studies, 3289 participants; low-quality evidence); vitamin A deficiency by 58% (RR 0.42, 95% CI 0.28 to 0.62; 6 studies, 1482 participants; low-quality evidence), vitamin B2 deficiency by 64% (RR 0.36, 95% CI 0.19 to 0.68; 1 study, 296 participants; low-quality evidence), vitamin B6 deficiency by 91% (RR 0.09, 95% CI 0.02 to 0.38; 2 studies, 301 participants; low-quality evidence), vitamin B12 deficiency by 58% (RR 0.42, 95% CI 0.25 to 0.71; 3 studies, 728 participants; low-quality evidence), weight-for-age z-scores (WAZ) (mean difference (MD) 0.1, 95% CI 0.02 to 0.17; 8 studies, 2889 participants; low-quality evidence) and weight-for-height/length z-score (WHZ/WLZ) (MD 0.1, 95% CI 0.02 to 0.18; 6 studies, 1758 participants; low-quality evidence). We are uncertain about the effect of MMN fortification on zinc deficiency (RR 0.84, 95% CI 0.65 to 1.08; 5 studies, 1490 participants; low-quality evidence) and height/length-for-age z-score (HAZ/LAZ) (MD 0.09, 95% CI 0.01 to 0.18; 8 studies, 2889 participants; low-quality evidence). Most of the studies in this comparison were conducted in children.\nSubgroup analyses of funding sources (commercial versus non-commercial) and duration of intervention did not demonstrate any difference in effects, although this was a relatively small number of studies and the possible association between commercial funding and increased effect estimates has been demonstrated in the wider health literature. We could not conduct subgroup analysis by food vehicle and funding; since there were too few studies in each subgroup to draw any meaningful conclusions.\nWhen we compared MMNs versus iodised salt, we are uncertain about the effect of MMN fortification on anaemia (R 0.86, 95% CI 0.37 to 2.01; 1 study, 88 participants; very low-quality evidence), iron deficiency anaemia (RR 0.40, 95% CI 0.09 to 1.83; 2 studies, 245 participants; very low-quality evidence), iron deficiency (RR 0.98, 95% CI 0.82 to 1.17; 1 study, 88 participants; very low-quality evidence) and vitamin A deficiency (RR 0.19, 95% CI 0.07 to 0.55; 2 studies, 363 participants; very low-quality evidence). Both of the studies were conducted in children.\nOnly one study conducted in children compared MMN fortification versus calcium fortification. None of the primary outcomes were reported in the study.\nNone of the included studies reported on morbidity, adverse events, all-cause or cause-specific mortality.\nAuthors' conclusions\nThe evidence from this review suggests that MMN fortification when compared to placebo/no intervention may reduce anaemia, iron deficiency anaemia and micronutrient deficiencies (iron, vitamin A, vitamin B2 and vitamin B6). We are uncertain of the effect of MMN fortification on anthropometric measures (HAZ/LAZ, WAZ and WHZ/WLZ). There are no data to suggest possible adverse effects of MMN fortification, and we could not draw reliable conclusions from various subgroup analyses due to a limited number of studies in each subgroup. We remain cautious about the level of commercial funding in this field, and the possibility that this may be associated with higher effect estimates, although subgroup analysis in this review did not demonstrate any impact of commercial funding. These findings are subject to study limitations, imprecision, high heterogeneity and small sample sizes, and we rated most of the evidence low to very low quality. and hence no concrete conclusions could be drawn from the findings of this review.\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": "Food fortification with MMN may reduce anaemia by 32%, iron deficiency anaemia by 72%, micronutrient deficiencies (including iron deficiency by 56%, vitamin A deficiency by 58%, vitamin B2 deficiency by 64%, vitamin B6 deficiency by 91% and vitamin B12 deficiency by 58%). MMN fortification may also improve child growth measured as weight for age and weight for height/length. We are uncertain of the effect of MMN fortification on zinc deficiency and child growth measured as height/length for age. The included studies did not report on any side effects associated with MMN fortification, including deaths and diseases. We are uncertain of the effect of food fortification with MMN compared to iodised salt for iron deficiency anaemia and vitamin A deficiency."
}
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query-laysum | 5038 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with febrile neutropaenia are usually treated in a hospital setting. Recently, treatment with oral antibiotics has been proven to be as effective as intravenous therapy. However, the efficacy and safety of outpatient treatment have not been fully evaluated.\nObjectives\nTo compare the efficacy (treatment failure and mortality) and safety (adverse events of antimicrobials) of outpatient treatment compared with inpatient treatment in people with cancer who have low-risk febrile neutropaenia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11) in the Cochrane Library, MEDLINE via Ovid (from 1948 to November week 4, 2018), Embase via Ovid (from 1980 to 2018, week 48) and trial registries (National Cancer Institute, MetaRegister of Controlled Trials, Medical Research Council Clinical Trial Directory). We handsearched all references of included studies and major reviews.\nSelection criteria\nRandomised controlled trials (RCTs) comparing outpatient with inpatient treatment for people with cancer who develop febrile neutropaenia. The outpatient group included those who started treatment as an inpatient and completed the antibiotic course at home (sequential) as well as those who started treatment at home.\nData collection and analysis\nTwo review authors independently assessed trial eligibility, methodological quality, and extracted data. Primary outcome measures were: treatment failure and mortality; secondary outcome measures considered were: duration of fever, adverse drug reactions to antimicrobial treatment, duration of neutropaenia, duration of hospitalisation, duration of antimicrobial treatment, and quality of life (QoL). We estimated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data; we calculated weighted mean differences for continuous data. Random-effects meta-analyses and sensitivity analyses were conducted.\nMain results\nWe included ten RCTs, six in adults (628 participants) and four in children (366 participants). We found no clear evidence of a difference in treatment failure between the outpatient and inpatient groups, either in adults (RR 1.23, 95% CI 0.82 to 1.85, I2 0%; six studies; moderate-certainty evidence) or children (RR 1.04, 95% CI 0.55 to 1.99, I2 0%; four studies; moderate-certainty evidence). For mortality, we also found no clear evidence of a difference either in studies in adults (RR 1.04, 95% CI 0.29 to 3.71; six studies; 628 participants; moderate-certainty evidence) or in children (RR 0.63, 95% CI 0.15 to 2.70; three studies; 329 participants; moderate-certainty evidence).\nAccording to the type of intervention (early discharge or exclusively outpatient), meta-analysis of treatment failure in four RCTs in adults with early discharge (RR 1.48, 95% CI 0.74 to 2.95; P = 0.26, I2 0%; 364 participants; moderate-certainty evidence) was similar to the results of the exclusively outpatient meta-analysis (RR 1.15, 95% CI 0.62 to 2.13; P = 0.65, I2 19%; two studies; 264 participants; moderate-certainty evidence).\nRegarding the secondary outcome measures, we found no clear evidence of a difference between outpatient and inpatient groups in duration of fever (adults: mean difference (MD) 0.2, 95% CI -0.36 to 0.76, 1 study, 169 participants; low-certainty evidence) (children: MD -0.6, 95% CI -0.84 to 0.71, 3 studies, 305 participants; low-certainty evidence) and in duration of neutropaenia (adults: MD 0.1, 95% CI -0.59 to 0.79, 1 study, 169 participants; low-certainty evidence) (children: MD -0.65, 95% CI -1.86 to 0.55, 2 studies, 268 participants; moderate-certainty evidence). With regard to adverse drug reactions, although there was greater frequency in the outpatient group, we found no clear evidence of a difference when compared to the inpatient group, either in adult participants (RR 8.39, 95% CI 0.38 to 187.15; three studies; 375 participants; low-certainty evidence) or children (RR 1.90, 95% CI 0.61 to 5.98; two studies; 156 participants; low-certainty evidence).\nFour studies compared the hospitalisation time and found that the mean number of days of hospital stay was lower in the outpatient treated group by 1.64 days in adults (MD -1.64, 95% CI -2.22 to -1.06; 3 studies, 251 participants; low-certainty evidence) and by 3.9 days in children (MD -3.90, 95% CI -5.37 to -2.43; 1 study, 119 participants; low-certainty evidence). In the 3 RCTs of children in which days of antimicrobial treatment were analysed, we found no difference between outpatient and inpatient groups (MD -0.07, 95% CI -1.26 to 1.12; 305 participants; low-certainty evidence).\nWe identified two studies that measured QoL: one in adults and one in children. QoL was slightly better in the outpatient group than in the inpatient group in both studies, but there was no consistency in the domains included.\nAuthors' conclusions\nOutpatient treatment for low-risk febrile neutropaenia in people with cancer probably makes little or no difference to treatment failure and mortality compared with the standard hospital (inpatient) treatment and may reduce time that patients need to be treated in hospital.\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": "In general, the studies were of moderate certainty."
}
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query-laysum | 5039 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is one of the most common infectious diseases in children. It has been reported that 64% of infants have an episode of AOM by the age of six months and 86% by one year. Although most cases of AOM are due to bacterial infection, it is commonly triggered by a viral infection. In most children AOM is self limiting, but it does carry a risk of complications. Since antibiotic treatment increases the risk of antibiotic resistance, influenza vaccines might be an effective way of reducing this risk by preventing the development of AOM.\nObjectives\nTo assess the effectiveness of influenza vaccine in reducing the occurrence of acute otitis media in infants and children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, LILACS, Web of Science, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov (15 February 2017). We also searched the reference lists of included studies to identify any additional trials.\nSelection criteria\nRandomised controlled trials comparing influenza vaccine with placebo or no treatment in infants and children aged younger than six years. We included children of either sex and of any ethnicity, with or without a history of recurrent AOM.\nData collection and analysis\nTwo review authors independently screened studies, assessed trial quality, and extracted data. We performed statistical analyses using the random-effects and fixed-effect models and expressed the results as risk ratio (RR), risk difference (RD), and number needed to treat for an additional beneficial outcome (NNTB) for dichotomous outcomes, with 95% confidence intervals (CI).\nMain results\nWe included 11 trials (6 trials in high-income countries and 5 multicentre trials in high-, middle-, and low-income countries) involving 17,123 children aged 6 months to 6 years. Eight trials recruited participants from a healthcare setting. Ten trials (and all four trials that contributed to the primary outcome) declared funding from vaccine manufacturers. Four trials reported adequate allocation concealment, and 10 trials reported adequate blinding of participants and personnel. Attrition was low for eight trials included in the analysis.\nThe primary outcome showed a small reduction in at least one episode of AOM over at least six months of follow-up (4 trials, 3134 children; RR 0.84, 95% CI 0.69 to 1.02; RD -0.04, 95% CI -0.08 to -0.00; NNTB 25, 95% CI 12.5 to 100; low-quality evidence).\nThe subgroup analyses (i.e. number of courses and types of vaccine administered) showed no differences.\nThere was a reduction in the use of antibiotics in vaccinated children (2 trials, 1223 children; RR 0.70, 95% CI 0.59 to 0.83; RD -0.11, 95% CI -0.16 to -0.06; moderate-quality evidence).\nWe were unable to demonstrate whether there was any difference in the utilisation of health care. The use of influenza vaccine resulted in a significant increase in fever (7 trials, 10,615 children; RR 1.15, 95% CI 1.06 to 1.24; RD 0.02, 95% CI 0.00 to 0.04; low-quality evidence), rhinorrhoea (6 trials, 10,563 children; RR 1.17, 95% CI 1.07 to 1.29; RD 0.09, 95% CI 0.01 to 0.16; low-quality evidence), but no difference in pharyngitis. No major adverse events were reported.\nDiffering from the protocol, the original publication of the review included a subgroup analysis of AOM episodes by season, and the secondary outcome ‘types of influenza vaccine’ was changed to a subgroup analysis. For this update, we removed the subgroup analyses for trial setting, season, and utilisation of health care due to the small number of trials involved. We removed Belshe 2000 from primary and secondary outcomes (courses of vaccine and types of vaccine) because it reported episodes of AOM per person. We did not perform a subgroup analysis by type of adverse event. We have reported each type of adverse event as a separate analysis.\nAuthors' conclusions\nInfluenza vaccine results in a small reduction in AOM. The observed reduction in the use of antibiotics needs to be considered in light of current recommended practices aimed at avoiding antibiotic overuse. Safety data from these trials were limited. The benefits may not justify the use of influenza vaccine without taking into account the vaccine efficacy in reducing influenza and safety data. We judged the quality of the evidence to be low to moderate. Additional research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the effect of influenza vaccine on preventing acute otitis media (AOM) in infants and children."
}
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query-laysum | 5040 | [
{
"role": "user",
"content": "Abstract: Background\nIn people with sickle cell disease, sickled red blood cells cause the occlusion of small blood vessels, which presents as episodes of severe pain known as pain crises or vaso-occlusive crises. The pain can occur in the bones, chest, or other parts of the body, and may last several hours to days. Pain relief during crises includes both pharmacologic and non-pharmacologic treatments. The efficacy of inhaled nitric oxide in pain crises has been a subject of controversy; hypotheses have been made suggesting a beneficial response due to its vasodilator properties, yet no conclusive evidence has been presented. This review aimed to evaluate the available randomised controlled studies addressing this topic.\nObjectives\nTo capture the body of evidence evaluating the efficacy and safety of the use of inhaled nitric oxide in treating pain crises in people with sickle cell disease, and to assess the relevance, robustness, and validity of the treatment to better guide medical practice in the fields of haematology and palliative care (since the recent literature seems to favour the involvement of palliative care for such people).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register. We searched for unpublished work in the abstract books of the European Haematology Association conference, the American Society of Hematology conference, the British Society for Haematology Annual Scientific Meeting, the Caribbean Health Research Council Meetings, and the National Sickle Cell Disease Program Annual Meeting. The most recent search was conducted on 1 September 2021. We also searched ongoing study registries on 19 November 2021.\nSelection criteria\nRandomised and quasi-randomised trials comparing inhaled nitric oxide with placebo for treating pain crises in people with sickle cell disease.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data (including adverse event data), with any disagreements resolved by consulting a third review author. When the data were not reported in the text, we attempted to extract the data from available tables or figures. We contacted trial authors for additional information. We assessed the certainty of the evidence using the GRADE criteria.\nMain results\nWe included three trials involving a total of 188 participants in the review. There were equal numbers of males and females. Most participants were adults, although one small trial was conducted in a children's hospital and recruited children over the age of 10 years. All three parallel trials compared inhaled nitric oxygen (80 parts per million (ppm)) to placebo (nitrogen gas mixed with oxygen or room air) for four hours; one trial continued administering nitric oxide (40 ppm) for a further four hours. This extended trial had an overall low risk of bias; however, we had concerns about risk of bias for the remaining two trials due to their small sample size, and additionally a high risk of bias due to financial conflicts of interest in one of these smaller trials. We were only able to analyse some limited data from the eight-hour trial, reporting the remaining results narratively.\nEvidence from one trial (150 participants) suggested that inhaled nitric oxide may not reduce the time to pain resolution: inhaled nitric oxide median 73.0 hours (95% confidence interval (CI) 46.0 to 91.0) and with placebo median 65.5 hours (95% CI 48.1 to 84.0) (low-certainty evidence). No trial reported on the duration of the initial pain crisis. Only one large trial reported on the frequency of pain crises in the follow-up period and found there may be little or no difference between the inhaled nitric oxide and placebo groups for return to the emergency department (risk ratio (RR) 0.73, 95% CI 0.31 to 1.71) and rehospitalisation (RR 0.53, 95% CI 0.25 to 1.11) (150 participants; low-certainty evidence).\nThere may be little or no difference between treatment and placebo in terms of reduction in pain score at any time point up to eight hours (150 participants). The two smaller trials reported a beneficial effect of inhaled nitric oxide in reducing the visual analogue pain score after four hours of the intervention.\nAnalgesic use was reported not to differ greatly between the inhaled nitric oxide group and placebo group in any of the three trials, but no analysable data were provided. Two trials reported the median duration of hospitalisation: in the largest trial the placebo group had the shorter duration, whilst in the second smaller (paediatric) trial hospitalisation was shorter in the treatment group.\nOnly the largest trial (150 participants) reported serious adverse events, with no increase in the inhaled nitric oxide group during or after the intervention compared to the control group (acute chest syndrome occurred in 5 out of 75 participants from each group, pyrexia in 1 out of 75 participants from each group, and dysphagia and a drop in haemoglobin were each reported in 1 out of 75 participants in the inhaled nitric oxide group) (low-certainty evidence).\nAuthors' conclusions\nThe currently available evidence is insufficient to determine the effects (benefits or harms) of using inhaled nitric oxide to treat pain (vaso-occlusive) crises in people with sickle cell disease. Large-scale, long-term trials are needed to provide more robust data in this area. Patient-important outcomes (e.g. measures of pain and time to pain resolution and amounts of analgesics used), as well as use of healthcare services, should be measured and reported in a standardised manner.\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 judged the evidence that could be analysed to be of low certainty. We believe that the results in this review were affected because not all planned outcomes were reported in two trials, and the trials were small. Furthermore, the pharmaceutical industry financed the smaller adult trial, which should be considered when considering the results of this trial."
}
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query-laysum | 5041 | [
{
"role": "user",
"content": "Abstract: Background\nBacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of BV after antibiotic treatment. Therefore, the treatment of sexual partners could decrease the recurrence of infection and possibly the burden of the disease.\nObjectives\nTo assess the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for BV.\nSearch methods\nWe searched the Cochrane Sexually Transmitted Infections Group Specialized Register (23 July 2016), CENTRAL (1991 to 23 July 2016), MEDLINE (1946 to 23 July 2016), Embase (1974 to 23 July 2016), LILACS (1982 to 23 July 2016), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (23 July 2016), ClinicalTrials.gov (23 July 2016) and the Web of Science™ (2001 to 23 July 2016). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials (RCTs) that compared the concurrent use of any antibiotic treatment with placebo, no intervention or any other intervention by the sexual partners of women treated for BV.\nData collection and analysis\nThree review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in the included studies. We resolved any disagreements through consensus. We assessed the quality of the evidence using the GRADE approach.\nMain results\nSeven RCTs (1026 participants) met our inclusion criteria, and pharmaceutical industry funded four of these trials. Five trials (854 patients) compared any antibiotic treatment of sexual partners with placebo. Based on high quality evidence, antibiotic treatment does not increase the rate of clinical or symptomatic improvement in women during the first week (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.96 to 1.03; 712 participants, four studies; RR 1.06, 95% CI 1.00 to 1.12; 577 patients, three studies, respectively), between the first and fourth week (RR 1.02, 95% CI 0.94 to 1.11; 590 participants, three studies; RR 0.93, 95% CI 0.84 to 1.03; 444 participants, two studies; respectively) or after the fourth week (RR 0.98, 95% CI 0.90 to 1.07; 572 participants, four studies; RR 1.03, 95% CI 0.90 to 1.17; 296 participants, two studies; respectively). Antibiotic treatment does not led to a lower recurrence during the first and fourth week (RR 1.28, 95% CI 0.68 to 2.43; 218 participants, one study; low quality evidence) or after the fourth week of treatment (RR 1.00, 95% CI 0.67 to 1.52; 372 participants, three studies; low quality evidence) in women, but increases the frequency of adverse events (most frequently gastrointestinal symptoms) reported by sexual partners (RR 2.55, 95% CI 1.55 to 4.18; 477 participants, three studies; low quality evidence).\n\nTwo trials (172 participants) compared any antibiotic treatment for sexual partners with no intervention. When we compared it with no intervention, the effects of antibiotic treatment on recurrence rate after the fourth week (RR 1.71, 95% CI 0.65 to 4.55; 51 participants, one study), clinical improvement between the first and fourth week (RR 0.93, 95% CI 0.70 to 1.25; 152 participants, two studies) and symptomatic improvement after the fourth week (RR 0.66, 95% CI 0.39 to 1.11; 70 participants, one study) were imprecise and there were no differences between groups. We downgraded the quality of the evidence to low or very low.\nAuthors' conclusions\nHigh quality evidence shows that antibiotic treatment for sexual partners of women with BV, compared with placebo, does not increase the rate of clinical or symptomatic improvement during the first, between the first and fourth or after the fourth week into the women. Low quality evidence suggests that antibiotic treatment does not led to a lower recurrence rate during the first and fourth or after the fourth week of treatment into the women, but increases the frequency of adverse events reported by sexual partners. Finally, compared with no intervention, antibiotic treatment does not decrease the recurrence rate after the fourth week and does not increase the frequency of clinical or symptomatic improvement between the first and fourth or after the fourth week into the women, respectively.\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": "Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of infection after antibiotic treatment. Therefore, the treatment of sexual partners could offer the advantages of decreasing the recurrence of infection and possibly reducing the burden of the disease."
}
]
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query-laysum | 5042 | [
{
"role": "user",
"content": "Abstract: Background\nSpecific allergen immunotherapy (SIT) is a treatment that may improve disease severity in people with atopic eczema (AE) by inducing immune tolerance to the relevant allergen. A high quality systematic review has not previously assessed the efficacy and safety of this treatment.\nObjectives\nTo assess the effects of specific allergen immunotherapy (SIT), including subcutaneous, sublingual, intradermal, and oral routes, compared with placebo or a standard treatment in people with atopic eczema.\nSearch methods\nWe searched the following databases up to July 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 7, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), Web of Science™ (from 2005), the Global Resource of EczemA Trials (GREAT database), and five trials databases. We searched abstracts from recent European and North American allergy meetings and checked the references of included studies and review articles for further references to relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) of specific allergen immunotherapy that used standardised allergen extracts in people with AE.\nData collection and analysis\nTwo authors independently undertook study selection, data extraction (including adverse effects), assessment of risk of bias, and analyses. We used standard methodological procedures expected by Cochrane.\nMain results\nWe identified 12 RCTs for inclusion in this review; the total number of participants was 733. The interventions included SIT in children and adults allergic to either house dust mite (10 trials), grass pollen, or other inhalant allergens (two trials). They were administered subcutaneously (six trials), sublingually (four trials), orally, or intradermally (two trials). Overall, the risk of bias was moderate, with high loss to follow up and lack of blinding as the main methodological concern.\nOur primary outcomes were 'Participant- or parent-reported global assessment of disease severity at the end of treatment'; 'Participant- or parent-reported specific symptoms of eczema, by subjective measures'; and 'Adverse events, such as acute episodes of asthma or anaphylaxis'. SCORing Atopic Dermatitis (SCORAD) is a means of measuring the effect of atopic dermatitis by area (A); intensity (B); and subjective measures (C), such as itch and sleeplessness, which we used.\nFor 'Participant- or parent-reported global assessment of disease severity at the end of treatment', one trial (20 participants) found improvement in 7/9 participants (78%) treated with the SIT compared with 3/11 (27%) treated with the placebo (risk ratio (RR) 2.85, 95% confidence interval (CI) 1.02 to 7.96; P = 0.04). Another study (24 participants) found no difference: global disease severity improved in 8/13 participants (62%) treated with the SIT compared with 9/11 (81%) treated with the placebo (RR 0.75, 95% CI 0.45 to 1.26; P = 0.38). We did not perform meta-analysis because of high heterogeneity between these two studies. The quality of the evidence was low.\nFor 'Participant- or parent-reported specific symptoms of eczema, by subjective measures', two trials (184 participants) did not find that the SIT improved SCORAD part C (mean difference (MD) -0.74, 95% CI -1.98 to 0.50) or sleep disturbance (MD -0.49, 95% CI -1.03 to 0.06) more than placebo. For SCORAD part C itch severity, these two trials (184 participants) did not find that the SIT improved itch (MD -0.24, 95% CI -1.00 to 0.52). One other non-blinded study (60 participants) found that the SIT reduced itch compared with no treatment (MD -4.20, 95% CI -3.69 to -4.71) and reduced the participants' overall symptoms (P < 0.01), but we could not pool these three studies due to high heterogeneity. The quality of the evidence was very low.\nSeven trials reported systemic adverse reactions: 18/282 participants (6.4%) treated with the SIT had a systemic reaction compared with 15/210 (7.1%) with no treatment (RR 0.78, 95% CI 0.41 to 1.49; the quality of the evidence was moderate). The same seven trials reported local adverse reactions: 90/280 participants (32.1%) treated with the SIT had a local reaction compared with 44/204 (21.6%) in the no treatment group (RR 1.27, 95% CI 0.89 to 1.81). As these had the same study limitations, we deemed the quality of the evidence to also be moderate.\nOf our secondary outcomes, there was a significant improvement in 'Investigator- or physician-rated global assessment of disease severity at the end of treatment' (six trials, 262 participants; RR 1.48, 95% CI 1.16 to 1.88). None of the studies reported our secondary outcome 'Parent- or participant-rated eczema severity assessed using a published scale', but two studies (n = 184), which have been mentioned above, used SCORAD part C, which we included as our primary outcome 'Participant- or parent-reported specific symptoms of eczema, by subjective measures'.\nOur findings were generally inconclusive because of the small number of studies. We were unable to determine by subgroup analyses a particular type of allergen or a particular age or level of disease severity where allergen immunotherapy was more successful. We were also unable to determine whether sublingual immunotherapy was associated with more local adverse reactions compared with subcutaneous immunotherapy.\nAuthors' conclusions\nOverall, the quality of the evidence was low. The low quality was mainly due to the differing results between studies, lack of blinding in some studies, and relatively few studies reporting participant-centred outcome measures. We found limited evidence that SIT may be an effective treatment for people with AE. The treatments used in these trials were not associated with an increased risk of local or systemic reactions. Future studies should use high quality allergen formulations with a proven track record in other allergic conditions and should include participant-reported outcome measures.\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": "At least one in seven children and one in 50 adults suffer from atopic eczema, a skin condition characterised by an itchy red rash. People with atopic eczema are allergic to things in the environment, such as house dust mites, and exposure to what they are allergic to may make their eczema worse. Specific allergen immunotherapy is a treatment that involves a course of injections or drops under the tongue containing the substance to which a person is allergic. The treatment can reduce the severity of a person's allergy and may therefore be able to reduce symptoms of atopic eczema. We evaluated whether specific allergen immunotherapy was better or worse than a standard treatment or placebo at improving disease severity and symptoms as assessed by participants, parents, or investigators."
}
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query-laysum | 5043 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical site infections (SSI) can delay wound healing, impair cosmetic outcome and increase healthcare costs. Topical antibiotics are sometimes used to reduce microbial contaminant exposure following surgical procedures, with the aim of reducing SSIs.\nObjectives\nThe primary objective of this review was to determine whether the application of topical antibiotics to surgical wounds that are healing by primary intention reduces the incidence of SSI and whether it increases the incidence of adverse outcomes (allergic contact dermatitis, infections with patterns of antibiotic resistance and anaphylaxis).\nSearch methods\nIn May 2015 we searched: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL. We also searched clinical trial registries for ongoing studies, and bibliographies of relevant publications to identify further eligible trials. There was no restriction of language, date of study or setting. The search was repeated in May 2016 to ensure currency of included studies.\nSelection criteria\nAll randomized controlled trials (RCTs) and quasi-randomised trials that assessed the effects of topical antibiotics (any formulation, including impregnated dressings) in people with surgical wounds healing by primary intention were eligible for inclusion.\nData collection and analysis\nTwo review authors independently selected studies and independently extracted data. Two authors then assessed the studies for risk of bias. Risk ratios were calculated for dichotomous variables, and when a sufficient number of comparable trials were available, trials were pooled in a meta-analysis.\nMain results\nA total of 10 RCTs and four quasi-randomised trials with 6466 participants met the inclusion criteria. Six studies involved minor procedures conducted in an outpatient or emergency department setting; eight studies involved major surgery conducted in theatre. Nine different topical antibiotics were included. We included two three-arm trials, two four-arm trials and 10 two-arm trials. The control groups comprised; an alternative topical antibiotic (two studies), topical antiseptic (six studies) and no topical antibiotic (10 studies), which comprised inert ointment (five studies) no treatment (four studies) and one study with one arm of each.\nThe risk of bias of the 14 studies varied. Seven studies were at high risk of bias, five at unclear risk of bias and two at low risk of bias. Most risk of bias concerned risk of selection bias.\nTwelve of the studies (6259 participants) reported infection rates, although we could not extract the data for this outcome from one study. Four studies (3334 participants) measured allergic contact dermatitis as an outcome. Four studies measured positive wound swabs for patterns of antimicrobial resistance, for which there were no outcomes reported. No episodes of anaphylaxis were reported.\nTopical antibiotic versus no topical antibiotic\nWe pooled the results of eight trials (5427 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with no topical antibiotic (RR 0.61, 95% CI 0.42 to 0.87; moderate-quality evidence downgraded once for risk of bias). This equates to 20 fewer SSIs per 1000 patients treated with topical antibiotics (95% CI 7 to 29) and a number needed to treat for one additional beneficial outcome (NNTB) (i.e. prevention of one SSI) of 50.\nWe pooled the results of three trials (3012 participants) for the outcome of allergic contact dermatitis, however this comparison was underpowered, and it is unclear whether topical antibiotics affect the risk of allergic contact dermatitis (RR 3.94, 95% CI 0.46 to 34.00; very low-quality evidence, downgraded twice for risk of bias, once for imprecision).\nTopical antibiotic versus antiseptic\nWe pooled the results of five trials (1299 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with using topical antiseptics (RR 0.49, 95% CI 0.30 to 0.80; moderate-quality evidence downgraded once for risk of bias). This equates to 43 fewer SSIs per 1000 patients treated with topical antibiotics instead of antiseptics (95% CI 17 to 59) and an NNTB of 24.\nWe pooled the results of two trials (541 participants) for the outcome of allergic contact dermatitis; there was no clear difference in the risk of dermatitis between topical antibiotics and antiseptics, however this comparison was underpowered and a difference cannot be ruled out (RR 0.97, 95% CI 0.52 to 1.82; very low-quality evidence, downgraded twice for risk of bias and once for imprecision).\nTopical antibiotic versus topical antibiotic\nOne study (99 participants) compared mupirocin ointment with a combination ointment of neomycin/polymyxin B/bacitracin zinc for the outcome of SSI. There was no clear difference in the risk of SSI, however this comparison was underpowered (very low-quality evidence downgraded twice for risk of bias, once for imprecision).\nA four-arm trial involved two antibiotic arms (neomycin sulfate/bacitracin zinc/polymyxin B sulphate combination ointment versus bacitracin zinc, 219 participants). There was no clear difference in risk of SSI between the combination ointment and the bacitracin zinc ointment. The quality of evidence for this outcome was low, downgraded once for risk of bias, and once for imprecision.\nAuthors' conclusions\nTopical antibiotics applied to surgical wounds healing by primary intention probably reduce the risk of SSI relative to no antibiotic, and relative to topical antiseptics (moderate quality evidence). We are unable to draw conclusions regarding the effects of topical antibiotics on adverse outcomes such as allergic contact dermatitis due to lack of statistical power (small sample sizes). We are also unable to draw conclusions regarding the impact of increasing topical antibiotic use on antibiotic resistance. The relative effects of different topical antibiotics are unclear.\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": "The presence of micro-organisms, such as bacteria, at wound sites following surgery can result in surgical site infections for patients. Surgical site infections can result in increased healthcare costs, delays in wound healing and pain. Antibiotics are medicines that kill bacteria or prevent them from developing. Antibiotics can be taken by mouth (orally), directly into veins (intravenously), or applied directly to the skin (topically). Topical antibiotics are often applied to wounds after surgery because it is thought that they prevent surgical site infection. There are thought to be benefits in using antibiotics topically rather than orally or intravenously. As topical antibiotics act only on the area of the body where they are applied, there is less likelihood of unwanted effects that affect the whole body, such as nausea and diarrhoea. Topical antibiotics are also thought to reduce the chances of bacterial resistance (bacteria changing to become resistant to medication). However topical antibiotics can also have unwanted effects, the most common being an allergic reaction on the skin (contact dermatitis), which can cause redness, itching and pain at the site where the topical antibiotic was applied."
}
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query-laysum | 5044 | [
{
"role": "user",
"content": "Abstract: Background\nRecent cohort studies show that salt intake below 6 g is associated with increased mortality. These findings have not changed public recommendations to lower salt intake below 6 g, which are based on assumed blood pressure (BP) effects and no side-effects.\nObjectives\nTo assess the effects of sodium reduction on BP, and on potential side-effects (hormones and lipids)\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials up to April 2018 and a top-up search in March 2020: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions. The top-up search articles are recorded under \"awaiting assessment.\"\nSelection criteria\nStudies randomizing persons to low-sodium and high-sodium diets were included if they evaluated at least one of the outcome parameters (BP, renin, aldosterone, noradrenalin, adrenalin, cholesterol, high-density lipoprotein, low-density lipoprotein and triglyceride,.\nData collection and analysis\nTwo review authors independently collected data, which were analysed with Review Manager 5.3. Certainty of evidence was assessed using GRADE.\nMain results\nSince the first review in 2003 the number of included references has increased from 96 to 195 (174 were in white participants). As a previous study found different BP outcomes in black and white study populations, we stratified the BP outcomes by race.\nThe effect of sodium reduction (from 203 to 65 mmol/day) on BP in white participants was as follows: Normal blood pressure: SBP: mean difference (MD) -1.14 mmHg (95% confidence interval (CI): -1.65 to -0.63), 5982 participants, 95 trials; DBP: MD + 0.01 mmHg (95% CI: -0.37 to 0.39), 6276 participants, 96 trials. Hypertension: SBP: MD -5.71 mmHg (95% CI: -6.67 to -4.74), 3998 participants,88 trials; DBP: MD -2.87 mmHg (95% CI: -3.41 to -2.32), 4032 participants, 89 trials (all high-quality evidence).\nThe largest bias contrast across studies was recorded for the detection bias element. A comparison of detection bias low-risk studies versus high/unclear risk studies showed no differences.\nThe effect of sodium reduction (from 195 to 66 mmol/day) on BP in black participants was as follows: Normal blood pressure: SBP: mean difference (MD) -4.02 mmHg (95% CI:-7.37 to -0.68); DBP: MD -2.01 mmHg (95% CI:-4.37, 0.35), 253 participants, 7 trials. Hypertension: SBP: MD -6.64 mmHg (95% CI:-9.00, -4.27); DBP: MD -2.91 mmHg (95% CI:-4.52, -1.30), 398 participants, 8 trials (low-quality evidence).\nThe effect of sodium reduction (from 217 to 103 mmol/day) on BP in Asian participants was as follows: Normal blood pressure: SBP: mean difference (MD) -1.50 mmHg (95% CI: -3.09, 0.10); DBP: MD -1.06 mmHg (95% CI:-2.53 to 0.41), 950 participants, 5 trials. Hypertension: SBP: MD -7.75 mmHg (95% CI:-11.44, -4.07); DBP: MD -2.68 mmHg (95% CI: -4.21 to -1.15), 254 participants, 8 trials (moderate-low-quality evidence).\nDuring sodium reduction renin increased 1.56 ng/mL/hour (95%CI:1.39, 1.73) in 2904 participants (82 trials); aldosterone increased 104 pg/mL (95%CI:88.4,119.7) in 2506 participants (66 trials); noradrenalin increased 62.3 pg/mL: (95%CI: 41.9, 82.8) in 878 participants (35 trials); adrenalin increased 7.55 pg/mL (95%CI: 0.85, 14.26) in 331 participants (15 trials); cholesterol increased 5.19 mg/dL (95%CI:2.1, 8.3) in 917 participants (27 trials); triglyceride increased 7.10 mg/dL (95%CI: 3.1,11.1) in 712 participants (20 trials); LDL tended to increase 2.46 mg/dl (95%CI: -1, 5.9) in 696 participants (18 trials); HDL was unchanged -0.3 mg/dl (95%CI: -1.66,1.05) in 738 participants (20 trials) (All high-quality evidence except the evidence for adrenalin).\nAuthors' conclusions\nIn white participants, sodium reduction in accordance with the public recommendations resulted in mean arterial pressure (MAP) decrease of about 0.4 mmHg in participants with normal blood pressure and a MAP decrease of about 4 mmHg in participants with hypertension. Weak evidence indicated that these effects may be a little greater in black and Asian participants. The effects of sodium reduction on potential side effects (hormones and lipids) were more consistent than the effect on BP, especially in people with normal BP.\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": "One hundred and ninety-five intervention studies of 12296 individuals lasting three to 1100 days were included, which evaluated at least one of the effect measures. Participants were healthy or had elevated blood pressure. Longitudinal studies have shown that the effect of reduced salt intake on BP is stable after at maximum seven days and population studies have shown that very few people eat more than 14.5 g salt per day. Therefore, we also performed subgroup analyses of 131 studies with a duration of at least seven days and a salt intake of maximum 14.5 g."
}
]
|
query-laysum | 5045 | [
{
"role": "user",
"content": "Abstract: Background\nPost-stroke fatigue (PSF) is a common and distressing problem after stroke. The best ways to prevent or treat PSF are uncertain. Several different interventions can be argued to have a rational basis.\nObjectives\nTo determine whether, among people with stroke, any intervention reduces the proportion of people with fatigue, fatigue severity, or both; and to determine the effect of intervention on health-related quality of life, disability, dependency and death, and whether such intervention is cost effective.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched May 2014), Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 4), MEDLINE (1950 to May 2014), EMBASE (1980 to May 2014), CINAHL (1982 to May 2014), AMED (1985 to May 2014), PsycINFO (1967 to May 2014), Digital Dissertations (1861 to May 2014), British Nursing Index (1985 to May 2014), PEDro (searched May 2014) and PsycBITE (searched May 2014). We also searched four ongoing trials registries, scanned reference lists, performed citation tracking of included trials and contacted experts.\nSelection criteria\nTwo review authors independently scrutinised all titles and abstracts and excluded obviously irrelevant studies. We obtained the full texts for potentially relevant studies and three review authors independently applied the inclusion criteria. We included randomised controlled trials (RCTs) that compared an intervention with a control, or compared different interventions for PSF.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias for each included trial. The primary outcomes were severity of fatigue, or proportion of people with fatigue after treatment. We performed separate analyses for trials investigating efficacy in treating PSF, trials investigating efficacy in preventing PSF and trials not primarily investigating efficacy in PSF but which reported fatigue as an outcome. We pooled results from trials that had a control arm. For trials that compared different potentially active interventions without a control arm, we performed analyses for individual trials without pooling.\nWe calculated standardised mean difference (SMD) as the effect size for continuous outcomes and risk ratio (RR) for dichotomous outcomes. We pooled the results using a random-effects model and assessed heterogeneity using the I2 statistic. We performed separate subgroup analyses for pharmacological and non-pharmacological interventions. We also performed sensitivity analyses to assess the influence of methodological quality.\nMain results\nWe retrieved 12,490 citations, obtained full texts for 58 studies and included 12 trials (three from the 2008 search and nine from the 2014 search) with 703 participants. Eight trials primarily investigated the efficacy in treating PSF, of which six trials with seven comparisons provided data suitable for meta-analysis (five pharmacological interventions: fluoxetine, enerion, (-)-OSU6162, citicoline and a combination of Chinese herbs; and two non-pharmacological interventions: a fatigue education programme and a mindfulness-based stress reduction programme). The fatigue severity was lower in the intervention groups than in the control groups (244 participants, pooled SMD -1.07, 95% confidence interval (CI) -1.93 to -0.21), with significant heterogeneity between trials (I2 = 87%, degrees of freedom (df) = 6, P value < 0.00001). The beneficial effect was not seen in trials that had used adequate allocation concealment (two trials, 89 participants, SMD -0.38, 95% CI -0.80 to 0.04) or trials that had used adequate blinding of outcome assessors (four trials, 198 participants, SMD -1.10, 95% CI -2.31 to 0.11).\nNo trial primarily investigated the efficacy in preventing PSF.\nFour trials (248 participants) did not primarily investigate the efficacy on fatigue but other symptoms after stroke. None of these interventions showed any benefit on reducing PSF, which included tirilazad mesylate, continuous positive airway pressure for sleep apnoea, antidepressants and a self management programme for recovery from chronic diseases.\nAuthors' conclusions\nThere was insufficient evidence on the efficacy of any intervention to treat or prevent fatigue after stroke. Trials to date have been small and heterogeneous, and some have had a high risk of bias. Some of the interventions described were feasible in people with stroke, but their efficacy should be investigated in RCTs with a more robust study design and adequate sample sizes.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was insufficient evidence to support the use of any intervention to treat or prevent fatigue in people with stroke."
}
]
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query-laysum | 5047 | [
{
"role": "user",
"content": "Abstract: Background\nAnxiety and depression affect many people. Treatments do not have complete success and often require people to take drugs for long periods of time. Many people look for other treatments that may help. One of those is Reiki, a 2500 year old treatment described as a vibrational or subtle energy therapy, and is most commonly facilitated by light touch on or above the body. There have been reports of Reiki alleviating anxiety and depression, but no specific systematic review.\nObjectives\nTo assess the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.\nSearch methods\nSearch of the Cochrane Register of Controlled Trials (CENTRAL - all years), the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR - all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014.\nSelection criteria\nRandomised trials in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner.\nData collection and analysis\nThe two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified but was not needed as the data were too sparse.\nMain results\nWe found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.\nThese studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively. They show no evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduces the certainty of the evidence.\nAuthors' conclusions\nThere is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.\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 three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.These studies included people with anxiety or depression or both, and reported their results separately. This included only 25 people with anxiety, 17 with depression and 20 more with either anxiety or depression but which was not specified. The search is up to date as of 4 November 2014."
}
]
|
query-laysum | 5048 | [
{
"role": "user",
"content": "Abstract: Background\nEarly diagnosis and treatment of lower respiratory tract infections are the mainstay of management of lung disease in cystic fibrosis. When sputum samples are unavailable, treatment relies mainly on cultures from oropharyngeal specimens; however, there are concerns regarding the sensitivity of these to identify lower respiratory organisms.\nBronchoscopy and related procedures (including bronchoalveolar lavage) though invasive, allow the collection of lower respiratory specimens from non-sputum producers. Cultures of bronchoscopic specimens provide a higher yield of organisms compared to those from oropharyngeal specimens. Regular use of bronchoscopy and related procedures may help in a more accurate diagnosis of lower respiratory tract infections and guide the selection of antimicrobials, which may lead to clinical benefits.\nThis is an update of a previous review.\nObjectives\nTo evaluate the use of bronchoscopy-guided antimicrobial therapy in the management of lung infection in adults and children with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of latest search: 30 August 2018.\nWe also searched three registries of ongoing studies and the reference lists of relevant articles and reviews. Date of latest search: 10 April 2018.\nSelection criteria\nWe included randomized controlled studies including people of any age with cystic fibrosis, comparing outcomes following therapies guided by the results of bronchoscopy (and related procedures) with outcomes following therapies guided by the results of any other type of sampling (including cultures from sputum, throat swab and cough swab).\nData collection and analysis\nTwo review authors independently selected studies, assessed their risk of bias and extracted data. We contacted study investigators for further information. The quality of the evidence was assessed using the GRADE criteria.\nMain results\nThe search identified 11 studies, but we only included one study enrolling infants with cystic fibrosis under six months of age and diagnosed through newborn screening (170 enrolled); participants were followed until they were five years old (data from 157 children). The study compared outcomes following therapy directed by bronchoalveolar lavage for pulmonary exacerbations with standard treatment based on clinical features and oropharyngeal cultures.\nWe considered this study to have a low risk of bias; however, the statistical power to detect a significant difference in the prevalence of Pseudomonas aeruginosa was limited due to the prevalence (of Pseudomonas aeruginosa isolation in bronchoalveolar lavage samples at five years age) being much lower in both the groups compared to that which was expected and which was used for the power calculation. The sample size was adequate to detect a difference in high-resolution computed tomography scoring. The quality of evidence for the key parameters was graded as low except high-resolution computed tomography scoring and cost of care analysis, which were graded as moderate quality.\nAt five years of age, there was no clear benefit of bronchoalveolar lavage-directed therapy on lung function z scores or nutritional parameters. Evaluation of total and component high-resolution computed tomography scores showed no significant difference in evidence of structural lung disease in the two groups.\nIn addition, this study did not show any difference between the number of isolates of Pseudomonas aeruginosa per child per year diagnosed in the bronchoalveolar lavage-directed therapy group compared to the standard therapy group. The eradication rate following one or two courses of eradication treatment was comparable in the two groups, as were the number of pulmonary exacerbations. However, the number of hospitalizations was significantly higher in the bronchoalveolar lavage-directed therapy group, but the mean duration of hospitalizations was significantly less compared to the standard therapy group.\nMild adverse events were reported in a proportion of participants, but these were generally well-tolerated. The most common adverse event reported was transient worsening of cough after 29% of procedures. Significant clinical deterioration was documented during or within 24 hours of bronchoalveolar lavage in 4.8% of procedures.\nAuthors' conclusions\nThis review, limited to a single, well-designed randomized controlled study, shows no clear evidence to support the routine use of bronchoalveolar lavage for the diagnosis and management of pulmonary infection in pre-school children with cystic fibrosis compared to the standard practice of providing treatment based on results of oropharyngeal culture and clinical symptoms. No evidence was available for adult and adolescent populations.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about whether to use samples obtained by bronchoscopy when deciding how to treat lung infections in people with cystic fibrosis."
}
]
|
query-laysum | 5049 | [
{
"role": "user",
"content": "Abstract: Background\nPrinted educational materials are widely used dissemination strategies to improve the quality of healthcare professionals' practice and patient health outcomes. Traditionally they are presented in paper formats such as monographs, publication in peer-reviewed journals and clinical guidelines. This is the fourth update of the review.\nObjectives\nTo assess the effect of printed educational materials (PEMs) on the practice of healthcare professionals and patient health outcomes.\nTo explore the influence of some of the characteristics of the printed educational materials (e.g. source, content, format) on their effect on healthcare professionals' practice and patient health outcomes.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), HealthStar, CINAHL, ERIC, CAB Abstracts, Global Health, and EPOC Register from their inception to 6 February 2019. We checked the reference lists of all included studies and relevant systematic reviews.\nSelection criteria\nWe included randomised trials (RTs), controlled before-after studies (CBAs) and interrupted time series studies (ITSs) that evaluated the impact of PEMs on healthcare professionals' practice or patient health outcomes. We included three types of comparisons: (1) PEM versus no intervention, (2) PEM versus single intervention, (3) multifaceted intervention where PEM is included versus multifaceted intervention without PEM. Any objective measure of professional practice (e.g. prescriptions for a particular drug), or patient health outcomes (e.g. blood pressure) were included.\nData collection and analysis\nTwo reviewers undertook data extraction independently. Disagreements were resolved by discussion. For analyses, we grouped the included studies according to study design, type of outcome and type of comparison. For controlled trials, we reported the median effect size for each outcome within each study, the median effect size across outcomes for each study and the median of these effect sizes across studies. Where data were available, we re-analysed the ITS studies by converting all data to a monthly basis and estimating the effect size from the change in the slope of the regression line between before and after implementation of the PEM. We reported median changes in slope for each outcome, for each study, and then across studies. We standardised all changes in slopes by their standard error, allowing comparisons and combination of different outcomes. We categorised each PEM according to potential effects modifiers related to the source of the PEMs, the channel used for their delivery, their content, and their format. We assessed the risks of bias of all the included studies.\nMain results\nWe included 84 studies: 32 RTs, two CBAs and 50 ITS studies. Of the 32 RTs, 19 were cluster RTs that used various units of randomisation, such as practices, health centres, towns, or areas.\nThe majority of the included studies (82/84) compared the effectiveness of PEMs to no intervention. Based on the RTs that provided moderate-certainty evidence, we found that PEMs distributed to healthcare professionals probably improve their practice, as measured with dichotomous variables, compared to no intervention (median absolute risk difference (ARD): 0.04; interquartile range (IQR): 0.01 to 0.09; 3,963 healthcare professionals randomised within 3073 units). We could not confirm this finding using the evidence gathered from continuous variables (standardised mean difference (SMD): 0.11; IQR: -0.16 to 0.52; 1631 healthcare professionals randomised within 1373 units ), from the ITS studies (standardised median change in slope = 0.69; 35 studies), or from the CBA study because the certainty of this evidence was very low. We also found, based on RTs that provided moderate-certainty evidence, that PEMs distributed to healthcare professionals probably make little or no difference to patient health as measured using dichotomous variables, compared to no intervention (ARD: 0.02; IQR: -0.005 to 0.09; 935,015 patients randomised within 959 units). The evidence gathered from continuous variables (SMD: 0.05; IQR: -0.12 to 0.09; 6,737 patients randomised within 594 units) or from ITS study results (standardised median change in slope = 1.12; 8 studies) do not strengthen these findings because the certainty of this evidence was very low.\nTwo studies (a randomised trial and a CBA) compared a paper-based version to a computerised version of the same PEM. From the RT that provided evidence of low certainty, we found that PEM in computerised versions may make little or no difference to professionals' practice compared to PEM in printed versions (ARD: -0.02; IQR: -0.03 to 0.00; 139 healthcare professionals randomised individually). This finding was not strengthened by the CBA study that provided very low certainty evidence (SMD: 0.44; 32 healthcare professionals).\nThe data gathered did not allow us to conclude which PEM characteristics influenced their effectiveness.\nThe methodological quality of the included studies was variable. Half of the included RTs were at risk of selection bias. Most of the ITS studies were conducted retrospectively, without prespecifying the expected effect of the intervention, or acknowledging the presence of a secular trend.\nAuthors' conclusions\nThe results of this review suggest that, when used alone and compared to no intervention, PEMs may slightly improve healthcare professionals' practice outcomes and patient health outcomes. The effectiveness of PEMs compared to other interventions, or of PEMs as part of a multifaceted intervention, is uncertain.\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": "Medical journals and clinical practice guidelines are common channels to distribute scientific information to healthcare professionals, as they allow a wide distribution at relatively low cost. Delivery of printed educational materials is meant to improve healthcare professionals' awareness, knowledge, attitudes, and skills, and ultimately improve their practice and patients' health outcomes."
}
]
|
query-laysum | 5050 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is a mood disorder with a prevalence of approximately 1% to 3% worldwide, representing the fourth leading cause of disease burden globally. The current standard treatments of psychological therapy and antidepressant medications are not effective for everyone, and psychotropic drugs may be associated with significant adverse effects. Cranial electrical stimulation (CES) treatment, in which a low intensity electrical current is administered through the use of a small, portable electrical device, has been reported to have efficacy in the treatment of depression with minimal adverse effects. This systematic review investigated the scientific evidence regarding the efficacy and safety of CES in treatment of acute depression compared to sham, or simulated, CES treatment.\nObjectives\nTo assess the effectiveness and safety of alternating current cranial electrotherapy stimulation (CES) compared with sham CES for acute depression.\nSearch methods\nWe searched The Cochrane Collaboration Depression, Anxiety and Neurosis review group's specialized register (CCDANCTR-Studies and CCDANCTR-References) to February 24, 2014 This register contains relevant randomized controlled trials from: The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We examined reference lists of review papers and books on CES. We contacted authors, other experts in the field and CES manufacturing companies for knowledge of suitable published or unpublished trials.\nSelection criteria\nRandomized controlled trials of CES versus sham CES for the acute treatment of depressive disorder in adults aged 18 to 75 years.\nData collection and analysis\nWe planned to extract data from the original reports of included studies independently by two authors. The main outcomes to be assessed were:\n(1) the efficacy of CES in reducing symptoms of depression as reflected in change scores on standardized depression rating scales.\n(2) the tolerability of CES treatment to participants, as reflected in rates of discontinuation due to adverse effects.\nWe planned to analyze data using Review Manager 5.\nMain results\nNo studies met the inclusion criteria for this review.\nAuthors' conclusions\nThere are insufficient methodologically rigorous studies of CES in treatment of acute depression. There is a need for double-blind randomized controlled trials of CES in the treatment of acute depression.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence on the use of cranial electrical stimulation (CES) in people with acute depression. More specifically, we were interested in examining the evidence from high quality clinical trials in which patients with acute depression were randomly assigned to treatment with either active CES or sham (simulated) CES, We found no high quality studies."
}
]
|
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