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query-laysum | 2427 | [
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory infections (ARIs) last for less than 30 days and are the most common acute diseases affecting people. Exercise has been shown to improve health generally, but it is uncertain whether exercise may be effective in reducing the occurrence, severity, and duration of ARIs. This is an update of our review published in 2015.\nObjectives\nTo evaluate the effectiveness of exercise for altering the occurrence, severity, or duration of acute respiratory infections.\nSearch methods\nWe searched CENTRAL (2020, Issue 2), MEDLINE (1948 to March week 1, 2020), Embase (1974 to 05 March 2020), CINAHL (1981 to 05 March 2020), LILACS (1982 to 05 March 2020), SPORTDiscus (1985 to 05 March 2020), PEDro (searched 05 March 2020), OTseeker (searched 05 March 2020), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (searched 05 March 2020).\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs (method of allocation that is not truly random, e.g. based on date of birth, medical record number) of exercise for ARIs in the general population.\nData collection and analysis\nTwo review authors independently extracted data from the included trials using a standard form. One review author entered data, which a second review author checked. We contacted trial authors to request missing data. There were sufficient differences in the populations trialed and in the nature of the interventions to use the random-effects model (which makes fewer assumptions than the fixed-effect model) in the analysis.\nMain results\nWe included three new trials for this update (473 participants) for a total of 14 trials involving 1377 adults, published between 1990 and 2018. Nine trials were conducted in the USA, and one each in Brazil, Canada, Portugal, Spain, and Turkey.\nSample sizes ranged from 16 to 419 participants, aged from 18 to 85 years. The proportion of female participants ranged from 52% to 100%. Follow-up duration ranged from 1 to 36 weeks (median = 12 weeks).\nModerate-intensity aerobic exercise (walking, bicycling, treadmill, or a combination) was evaluated in 11 trials, and was most commonly prescribed at least three times a week for 30 to 45 minutes.\nThere was no difference between exercise and no exercise in the number of ARI episodes per person per year (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.77 to 1.30; 4 trials; 514 participants; low-certainty evidence); proportion of participants who experienced at least one ARI over the study period (RR 0.88, 95% CI 0.72 to 1.08; 5 trials; 520 participants; low-certainty evidence); and the number of symptom days per episode of illness (mean difference (MD) −0.44 day, 95% CI −2.33 to 1.46; 6 trials; 557 participants; low-certainty evidence). Exercise reduced the severity of ARI symptoms measured on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) (MD −103.57, 95% CI −198.28 to −8.87; 2 trials; 373 participants; moderate-certainty evidence) and the number of symptom days during follow-up period (MD −2.24 days, 95% CI −3.50 to −0.98; 4 trials; 483 participants; low-certainty evidence).\nExcercise did not have a significant effect on laboratory parameters (blood lymphocytes, salivary secretory immunoglobulin, and neutrophils), quality of life outcomes, cost-effectiveness, and exercise-related injuries. There was no difference in participant dropout between the intervention and control groups.\nOverall, the certainty of the evidence was low, downgraded mainly due to limitations in study design and implementation, imprecision, and inconsistency.\nSeven trials were funded by public agencies; five trials did not report funding; and two trials were funded by private companies.\nAuthors' conclusions\nExercise did not reduce the number of ARI episodes, proportion of participants experiencing at least one ARI during the study, or the number of symptom days per episode of illness. However, exercise reduced the severity of ARI symptoms (two studies) and the number of symptom days during the study follow-up period (four studies). Small study size, risk of bias, and heterogeneity in the populations studied contributed to the uncertainty of the findings. Larger trials that are designed to avoid risk of bias associated with participant selection, blinding of outcomes assessors, and with adequate reporting of all outcomes proposed for measurement in trials, would help to provide more robust evidence.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Exercise has been shown to improve health generally. We reviewed the evidence to find out whether exercise is also effective at changing the occurrence, severity, or duration of acute respiratory infections (colds and coughs) that last less than a month."
}
]
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query-laysum | 2428 | [
{
"role": "user",
"content": "Abstract: Background\nIn patients of various ages undergoing mechanical ventilation (MV), it has been observed that positions other than the standard supine position, such as the prone position, may improve respiratory parameters. The benefits of these positions have not been clearly defined for critically ill newborns receiving MV.\nThis is an update of a review first published in 2005 and last updated in 2013.\nObjectives\nPrimary objective\nTo assess the effects of different positioning of newborn infants receiving MV (supine vs prone, lateral decubitus or quarter turn from prone) in improving short-term respiratory outcomes.\nSecondary objective\nTo assess the effects of different positioning of newborn infants receiving MV on mortality and neuromotor and developmental outcomes over the long term, and on other complications of prematurity.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8), MEDLINE via PubMed (1966 to 22 August 2016), Embase (1980 to 22 August 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 22 August 2016). We also searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised clinical trials comparing different positions in newborns receiving mechanical ventilation.\nData collection and analysis\nThree unblinded review authors independently assessed trials for inclusion in the review and extracted study data. We used standard methodological procedures as expected by The Cochrane Collaboration and assessed the quality of the evidence using the GRADE approach. If the meta-analysis was not appropriate owing to substantial clinical heterogeneity between trials, we presented review findings in narrative format.\nMain results\nWe included in this review 19 trials involving 516 participants. Seven of the included studies (N = 222) had not been evaluated in the previous review. Investigators compared several positions: prone versus supine, prone alternant versus supine, prone versus lateral right, lateral right versus supine, lateral left versus supine, lateral alternant versus supine, lateral right versus lateral left, quarter turn from prone versus supine, quarter turn from prone versus prone and good lung dependent versus good lung uppermost.\nApart from two studies that compared lateral alternant versus supine, one comparing lateral right versus supine and two comparing prone or prone alternant versus the supine position, all included studies had a cross-over design. In five studies, infants were ventilated with continuous positive airway pressure (CPAP); in the other studies, infants were treated with conventional ventilation (CV).\nRisks of bias did not differ substantially for different comparisons and outcomes. This update detects a moderate to high grade of inconsistency, similar to previous versions. However, for the analysed outcomes, the direction of effect was the same in all studies. Therefore, we consider that this inconsistency had little effect on the conclusions of the meta-analysis. When comparing prone versus supine position, we observed an increase in arterial oxygen tension (PO2) in the prone position (mean difference (MD) 5.49 mmHg, 95% confidence interval (CI) 2.92 to 8.05 mmHg; three trials; 116 participants; I2= 0). When percent haemoglobin oxygen saturation was measured with pulse oximetry (SpO2), improvement in the prone position was between 1.13% and 3.24% (typical effect based on nine trials with 154 participants; I2= 89%). The subgroup ventilated with CPAP (three trials; 59 participants) showed a trend towards improving SpO2 in the prone position compared with the supine position, although the mean difference (1.91%) was not significant (95% CI -1.14 to 4.97) and heterogeneity was extreme (I2= 95%).\nSensitivity analyses restricted to studies with low risk of selection bias showed homogeneous results and verified a small but significant effect (MD 0.64, 95% CI 0.26 to 1.02; four trials; 92 participants; I2= 0).\nWe also noted a slight improvement in the number of episodes of desaturation; it was not possible to establish whether this effect continued once the intervention was stopped. Investigators studied few adverse effects from the interventions in sufficient detail. Two studies analysed tracheal cultures of neonates after five days on MV, reporting lower bacterial colonisation in the alternating lateral position than in the supine posture. Other effects - positive or negative - cannot be excluded in light of the relatively small numbers of neonates studied.\nAuthors' conclusions\nThis update of our last review in 2013 supports previous conclusions. Evidence of low to moderate quality favours the prone position for slightly improved oxygenation in neonates undergoing mechanical ventilation. However, we found no evidence to suggest that particular body positions during mechanical ventilation of the neonate are effective in producing sustained and clinically relevant improvement.\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": "Confidence in review conclusions depends on the characteristics of included studies such as risk of bias (design limitations), consistency (heterogeneity across studies), precision (small confidence interval) and directness (same effect), and requires that all included studies were published independently of their outcomes.\nThe quality of evidence for these outcomes allows us to have very low to moderate confidence in our conclusions."
}
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query-laysum | 2429 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pulmonary infection in cystic fibrosis results in progressive lung damage. Once colonisation of the lungs with Pseudomonas aeruginosa occurs, it is almost impossible to eradicate. Vaccines, aimed at reducing infection with Pseudomonas aeruginosa, have been developed. This is an update of a previously published review.\nObjectives\nTo assess the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register using the terms vaccines AND pseudomonas (last search 30 March 2015). We previously searched PubMed using the terms vaccin* AND cystic fibrosis (last search 30 May 2013).\nSelection criteria\nRandomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis.\nData collection and analysis\nThe authors independently selected trials, assessed them and extracted data.\nMain results\nSix trials were identified. Two trials were excluded since they were not randomised and one old, small trial because it was not possible to assess whether is was randomised. The three included trials comprised 483, 476 and 37 patients, respectively. No data have been published from one of the large trials, but the company stated in a press release that the trial failed to confirm the results from an earlier study and that further clinical development was suspended. In the other large trial, relative risk for chronic infection was 0.91 (95% confidence interval 0.55 to 1.49), and in the small trial, the risk was also close to one. In the large trial, one patient was reported to have died in the observation period. In that trial, 227 adverse events (4 severe) were registered in the vaccine group and 91 (1 severe) in the control group. In this large trial of a vaccine developed against flagella antigens, antibody titres against the epitopes contained in the vaccine were higher in the vaccine group compared to the placebo group (P < 0.0001).\nAuthors' conclusions\nVaccines against Pseudomonas aeruginosa cannot be recommended.\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 were only able to present the results from one of the large trials (483 cystic fibrosis patients) comparing an active vaccine to a placebo and the small trial (37 cystic fibrosis patients) with a no vaccination comparison group. Results for the second large trial have not been published, but the manufacturers stated that results did not confirm the findings from an earlier trial and that further clinical development had been suspended. The results we have from the two trials show that after vaccination the risk of getting a chronic infection did not decrease and lung function was similar in both groups of cystic fibrosis patients. One of the patients from the large trial died during the two year follow-up period; in the small trial, one patient from each group had died after seven to eight years and by the end of the trial (10 to 12 years) six patients in each group had died. Those who died were all chronically infected with Pseudomonas aeruginosa. Investigators in the large trial, recorded 227 adverse events (four of which were classed as severe) in the vaccine group and 91 (one of which was classed as severe) in the placebo group. The large trial also reported a rise in antibodies against Pseudomonas aeruginosa with no change in the placebo group.\nOn the basis of these results, we cannot recommend the use of vaccines against Pseudomonas aeruginosa in patients with cystic fibrosis."
}
]
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query-laysum | 2430 | [
{
"role": "user",
"content": "Abstract: Background\nClinicians must balance the risks of bleeding and thrombosis after percutaneous coronary intervention (PCI) in people with an indication for anticoagulation. The potential of non-vitamin K antagonists (NOACs) to prevent bleeding complications is promising, but evidence remains limited.\nObjectives\nTo review the evidence from randomised controlled trials assessing the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared to vitamin K antagonists post-percutaneous coronary intervention (PCI) in people with an indication for anticoagulation.\nSearch methods\nWe identified studies by searching CENTRAL, MEDLINE, Embase, the Conference Proceedings Citation Index – Science and two clinical trials registers in February 2019. We checked bibliographies of identified studies and applied no language restrictions.\nSelection criteria\nWe searched for randomised controlled trials (RCT) that compared NOACs and vitamin K antagonists for people with an indication for anticoagulation who underwent PCI.\nData collection and analysis\nTwo review authors independently checked the results of searches to identify relevant studies, assessed each included study, and extracted study data. We conducted random-effects, pairwise analyses using Review Manager 5 and network meta-analyses (NMA) using the R package 'netmeta'. We ranked competing treatments by P scores, which are derived from the P values of all pairwise comparisons, and allow ranking of treatments on a continuous 0 to 1 scale.\nMain results\nWe identified nine RCTs that met the inclusion criteria, but four were ongoing trials, and were not included in this analysis. We included five RCTs, with 8373 participants, in the NMA (two RCTs compared apixaban to a vitamin K antagonist, two RCTs compared rivaroxaban to a vitamin K antagonist, and one RCT compared dabigatran to a vitamin K antagonist).\nVery low- to moderate-certainty evidence suggests little or no difference between NOACs and vitamin K antagonists in death from cardiovascular causes (not reported in the dabigatran trial), myocardial infarction, stroke, death from any cause, and stent thrombosis. Apixaban (RR 0.85, 95% CI 0.77 to 0.95), high dose rivaroxaban (RR 0.86, 95% CI 0.74 to 1.00), and low dose rivaroxaban (RR 0.80, 95% CI 0.68 to 0.92) probably reduce the risk of recurrent hospitalisation compared with vitamin K antagonists. No studies looked at health-related quality of life.\nVery low- to moderate-certainty evidence suggests that NOACs may be safer than vitamin K antagonists in terms of bleeding. Both high dose dabigatran (RR 0.53, 95% CI 0.29 to 0.97), and low dose dabigatran (RR 0.38, 95% CI 0.21 to 0.70) may reduce major bleeding more than vitamin K antagonists. High dose dabigatran (RR 0.83, 95% CI 0.72 to 0.96), low dose dabigatran (RR 0.66, 95% CI 0.58 to 0.75), apixaban (RR 0.67, 95% Cl 0.51 to 0.88), high dose rivaroxaban (RR 0.66, 95% CI 0.52 to 0.83), and low dose rivaroxaban (RR 0.71, 95% CI 0.57 to 0.88) probably reduce non-major bleeding more than vitamin K antagonists.\nThe results from the NMA were inconclusive between the different NOACs for all primary and secondary outcomes.\nAuthors' conclusions\nVery low- to moderate-certainty evidence suggests no meaningful difference in efficacy outcomes between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists following percutaneous coronary interventions (PCI) in people with non-valvular atrial fibrillation. NOACs probably reduce the risk of recurrent hospitalisation for adverse events compared with vitamin K antagonists.\nLow- to moderate-certainty evidence suggests that dabigatran may reduce the rates of major and non-major bleeding, and apixaban and rivaroxaban probably reduce the rates of non-major bleeding compared with vitamin K antagonists.\nOur network meta-analysis did not show superiority of one NOAC over another for any of the outcomes. Head to head trials, directly comparing NOACs against each other, are required to provide more certain evidence.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Choosing the optimal treatment for people on long term blood thinners (due to atrial fibrillation), who require a heart vessel stent placement (after a heart attack or angina) remains a challenge in clinical practice. They need to take blood thinners to prevent a stroke, and antiplatelet drugs to prevent blood clots in the stents. However, this combination increases the risk of potentially life-threatening bleeding, and thus, the optimal treatment remains uncertain. The aim of this review was to investigate whether next-generation blood thinners (NOACs) are safer and more effective than older blood-thinning medications (such as warfarin) in this group of individuals."
}
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query-laysum | 2431 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough the benefits of vision screening seem intuitive, the value of such programmes in junior and senior schools has been questioned. In addition there exists a lack of clarity regarding the optimum age for screening and frequency at which to carry out screening.\nObjectives\nTo evaluate the effectiveness of vision screening programmes carried out in schools to reduce the prevalence of correctable visual acuity deficits due to refractive error in school-age children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 4); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 3 May 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs), including cluster-randomised trials, that compared vision screening with no vision screening, or compared interventions to improve uptake of spectacles or efficiency of vision screening.\nData collection and analysis\nTwo review authors independently screened search results and extracted data. Our pre-specified primary outcome was uncorrected, or suboptimally corrected, visual acuity deficit due to refractive error six months after screening. Pre-specified secondary outcomes included visual acuity deficit due to refractive error more than six months after screening, visual acuity deficit due to causes other than refractive error, spectacle wearing, quality of life, costs, and adverse effects. We graded the certainty of the evidence using GRADE.\nMain results\nWe identified seven relevant studies. Five of these studies were conducted in China with one study in India and one in Tanzania. A total of 9858 children aged between 10 and 18 years were randomised in these studies, 8240 of whom (84%) were followed up between one and eight months after screening. Overall we judged the studies to be at low risk of bias. None of these studies compared vision screening for correctable visual acuity deficits with not screening.\nTwo studies compared vision screening with the provision of free spectacles versus vision screening with no provision of free spectacles (prescription only). These studies provide high-certainty evidence that vision screening with provision of free spectacles results in a higher proportion of children wearing spectacles than if vision screening is accompanied by provision of a prescription only (risk ratio (RR) 1.60, 95% confidence interval (CI) 1.34 to 1.90; 1092 participants). The studies suggest that if approximately 250 per 1000 children given vision screening plus prescription only are wearing spectacles at follow-up (three to six months) then 400 per 1000 (335 to 475) children would be wearing spectacles after vision screening and provision of free spectacles. Low-certainty evidence suggested better educational attainment in children in the free spectacles group (adjusted difference 0.11 in standardised mathematics score, 95% CI 0.01 to 0.21, 1 study, 2289 participants). Costs were reported in one study in Tanzania in 2008 and indicated a relatively low cost of screening and spectacle provision (low-certainty evidence). There was no evidence of any important effect of provision of free spectacles on uncorrected visual acuity (mean difference -0.02 logMAR (95% CI adjusted for clustering -0.04 to 0.01) between the groups at follow-up (moderate-certainty evidence). Other pre-specified outcomes of this review were not reported.\nTwo studies explored the effect of an educational intervention in addition to vision screening on spectacle wear. There was moderate-certainty evidence of little apparent effect of the education interventions investigated in these studies in addition to vision screening, compared to vision screening alone for spectacle wearing (RR 1.11, 95% CI 0.95 to 1.31, 1 study, 3177 participants) or related outcome spectacle purchase (odds ratio (OR) 0.84, 95% CI 0.55 to 1.31, 1 study, 4448 participants). Other pre-specified outcomes of this review were not reported.\nThree studies compared vision screening with ready-made spectacles versus vision screening with custom-made spectacles. These studies provide moderate-certainty evidence of no clinically meaningful differences between the two types of spectacles. In one study, mean logMAR acuity in better and worse eye was similar between groups: mean difference (MD) better eye 0.03 logMAR, 95% CI 0.01 to 0.05; 414 participants; MD worse eye 0.06 logMAR, 95% CI 0.04 to 0.08; 414 participants). There was high-certainty evidence of no important difference in spectacle wearing (RR 0.98, 95% CI 0.91 to 1.05; 1203 participants) between the two groups and moderate-certainty evidence of no important difference in quality of life between the two groups (the mean quality-of-life score measured using the National Eye Institute Refractive Error Quality of Life scale 42 was 1.42 better (1.04 worse to 3.90 better) in children with ready-made spectacles (1 study of 188 participants). Although none of the studies reported on costs directly, ready-made spectacles are cheaper and may represent considerable cost-savings for vision screening programmes in lower income settings. There was low-certainty evidence of no important difference in adverse effects between the two groups. Adverse effects were reported in one study and were similar between groups. These included blurred vision, distorted vision, headache, disorientation, dizziness, eyestrain and nausea.\nAuthors' conclusions\nVision screening plus provision of free spectacles improves the number of children who have and wear the spectacles they need compared with providing a prescription only. This may lead to better educational outcomes. Health education interventions, as currently devised and tested, do not appear to improve spectacle wearing in children. In lower-income settings, ready-made spectacles may provide a useful alternative to expensive custom-made spectacles.\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": "Cochrane Review authors searched for studies that had been published up to 3 May 2017."
}
]
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query-laysum | 2432 | [
{
"role": "user",
"content": "Abstract: Background\nTramadol is often prescribed to treat pain and associated physical disability in osteoarthritis (OA). Due to the pharmacologic mechanism of tramadol, it may lead to fewer associated adverse effects (i.e. gastrointestinal bleeding or renal problems) compared to non-steroidal anti-inflammatory drugs (NSAIDs). This is an update of a Cochrane Review originally published in 2006.\nObjectives\nTo determine the benefits and harms of oral tramadol or tramadol combined with acetaminophen or NSAIDs in people with osteoarthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases, as well as the US National Institutes of Health and World Health Organization trial registries up to February 2018. We searched the LILACS database up to August 2015.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated the effect of tramadol, or tramadol in combination with acetaminophen (paracetamol) or NSAIDs versus placebo or any comparator in people with osteoarthritis.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane.\nMain results\nWe included 22 RCTs (11 more than the previous review) of which 21 RCTs were included in meta-analyses for 3871 participants randomized to tramadol alone or tramadol in combination with another analgesic and 2625 participants randomized to placebo or active control. Seventeen studies evaluated tramadol alone and five evaluated tramadol plus acetaminophen. Thirteen studies used placebo controls and eleven studies used active controls (two trials had both placebo and active arms). The dose of tramadol ranged from 37.5 mg to 400 mg daily; all doses were pooled. Most trials were multicenter with a mean duration of two months. Participants were predominantly women with hip or knee osteoarthritis, with a mean age of 63 years and moderate to severe pain. There was a high risk of selection bias as only four trials reported both adequate sequence generation and allocation concealment. There was a low risk for performance bias as most studies blinded participants. There was a high risk of attrition bias as 10/22 trials showed incomplete outcome data. Most of the trials were funded by the pharmaceutical industry.\nModerate quality evidence (downgraded due to risk of bias) indicated that tramadol alone and in combination with acetaminophen had no important benefit on pain reduction compared to placebo control (tramadol alone: 4% absolute improvement, 95% confidence interval (CI) 3% to 5%; 8 studies, 3972 participants; tramadol in combination with acetaminophen: 4% absolute improvement, 95% CI 2% to 6%; 2 studies, 614 participants).\nFifteen out of 100 people in the tramadol group improved by 20% (which corresponded to a clinically important difference in pain) compared to 10/100 in the placebo group (5% absolute improvement). Twelve out of 100 people improved by 20% in the tramadol in combination with acetaminophen group compared to 7/100 in the placebo group (5% absolute improvement).\nModerate quality evidence (downgraded due to risk of bias) indicated that tramadol alone and in combination with acetaminophen led to no important benefit in physical function compared to placebo (tramadol alone: 4% absolute improvement, 95% CI 2% to 6%; 5 studies, 2550 participants; tramadol in combination with acetaminophen: 4% absolute improvement, 95% CI 2% to 7%; 2 studies, 614 participants).\nTwenty-one out of 100 people in the tramadol group improved by 20% (which corresponded to a clinically important difference in physical function) compared to 16/100 in the placebo group (5% absolute improvement). Fifteen out of 100 people improved by 20% in the tramadol in combination with acetaminophen group compared to 10/100 in the placebo group (5% absolute improvement).\nModerate quality evidence (downgraded due to risk of bias) indicated that, compared to placebo, there was a greater risk of developing adverse events with tramadol alone (risk ratio (RR) 1.34, 95% CI 1.24 to 1.46; 4 studies, 2039 participants) and tramadol in combination with acetaminophen compared to placebo (RR 1.91, 95% CI 1.32 to 2.76; 1 study, 308 participants). This corresponded to a 17% increase (95% CI 12% to 23%) with tramadol alone and 22% increase (95% CI 8% to 41%) with tramadol in combination with acetaminophen.\nThe three most frequent adverse events were nausea, dizziness and tiredness. Moderate quality evidence (downgraded due to risk of bias) indicated that there was a greater risk of withdrawing from the study because of adverse events with tramadol alone compared to placebo (RR 2.64, 95% CI 2.17 to 3.20; 9 studies, 4533 participants), which corresponded to a 12% increase (95% CI 9% to 16%).\nLow quality evidence (downgraded due to risk of bias and inconsistency) indicated that there was a greater risk of withdrawing from the study because of adverse events with tramadol in combination with acetaminophen compared to placebo (RR 2.78, 95% CI 1.50 to 5.16; 2 studies, 614 participants), which corresponded to a 8% absolute improvement (95% CI 2% to 19%).\nLow quality evidence (downgraded due to risk of bias and imprecision) indicated that there was a greater risk of developing serious adverse events with tramadol alone compared to placebo (110/2459 participants with tramadol compared to 22/1153 participants with placebo; RR 1.78, 95% CI 1.11 to 2.84; 7 studies, 3612 participants), which corresponded to a 1% increase (95% CI 0% to 4%). There were no serious adverse events reported in one small study (15 participants) of tramadol with acetaminophen compared to placebo.\nAuthors' conclusions\nModerate quality evidence indicates that compared to placebo, tramadol alone or in combination with acetaminophen probably has no important benefit on mean pain or function in people with osteoarthritis, although slightly more people in the tramadol group report an important improvement (defined as 20% or more). Moderate quality evidence shows that adverse events probably cause substantially more participants to stop taking tramadol. The increase in serious adverse events with tramadol is less certain, due to the small number of events.\n\nGiven the provided abstract, please respond to the following query: \"Total side effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Sixty-six out of 100 people may have had side effects when taking tramadol alone compared to 49 out of 100 people when taking a placebo (17% more people)."
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query-laysum | 2433 | [
{
"role": "user",
"content": "Abstract: Background\nDementia is a chronic condition which progressively affects memory and other cognitive functions, social behaviour, and ability to carry out daily activities. To date, no treatment is clearly effective in preventing progression of the disease, and most treatments are symptomatic, often aiming to improve people's psychological symptoms or behaviours which are challenging for carers. A range of new therapeutic strategies has been evaluated in research, and the use of trained animals in therapy sessions, termed animal-assisted therapy (AAT), is receiving increasing attention.\nObjectives\nTo evaluate the efficacy and safety of animal-assisted therapy for people with dementia.\nSearch methods\nWe searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 5 September 2019. ALOIS contains records of clinical trials identified from monthly searches of major healthcare databases, trial registries, and grey literature sources. We also searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), ISI Web of Science, ClinicalTrials.gov, and the WHO's trial registry portal.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-randomised trials, and randomised cross-over trials that compared AAT versus no AAT, AAT using live animals versus alternatives such as robots or toys, or AAT versus any other active intervention.\nData collection and analysis\nWe extracted data using the standard methods of Cochrane Dementia. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using mean difference (MD), standardised mean difference (SMD), and risk ratio (RR) with their 95% confidence intervals (CIs) where appropriate.\nMain results\nWe included nine RCTs from 10 reports. All nine studies were conducted in Europe and the US. Six studies were parallel-group, individually randomised RCTs; one was a randomised cross-over trial; and two were cluster-RCTs that were possibly related where randomisation took place at the level of the day care and nursing home. We identified two ongoing trials from trial registries.\nThere were three comparisons: AAT versus no AAT (standard care or various non-animal-related activities), AAT using live animals versus robotic animals, and AAT using live animals versus the use of a soft animal toy. The studies evaluated 305 participants with dementia. One study used horses and the remainder used dogs as the therapy animal. The duration of the intervention ranged from six weeks to six months, and the therapy sessions lasted between 10 and 90 minutes each, with a frequency ranging from one session every two weeks to two sessions per week. There was a wide variety of instruments used to measure the outcomes. All studies were at high risk of performance bias and unclear risk of selection bias. Our certainty about the results for all major outcomes was very low to moderate.\nComparing AAT versus no AAT, participants who received AAT may be slightly less depressed after the intervention (MD –2.87, 95% CI –5.24 to –0.50; 2 studies, 83 participants; low-certainty evidence), but they did not appear to have improved quality of life (MD 0.45, 95% CI –1.28 to 2.18; 3 studies, 164 participants; moderate-certainty evidence). There were no clear differences in all other major outcomes, including social functioning (MD –0.40, 95% CI –3.41 to 2.61; 1 study, 58 participants; low-certainty evidence), problematic behaviour (SMD –0.34, 95% CI –0.98 to 0.30; 3 studies, 142 participants; very-low-certainty evidence), agitation (SMD –0.39, 95% CI –0.89 to 0.10; 3 studies, 143 participants; very-low-certainty evidence), activities of daily living (MD 4.65, 95% CI –16.05 to 25.35; 1 study, 37 participants; low-certainty evidence), and self-care ability (MD 2.20, 95% CI –1.23 to 5.63; 1 study, 58 participants; low-certainty evidence). There were no data on adverse events.\nComparing AAT using live animals versus robotic animals, one study (68 participants) found mixed effects on social function, with longer duration of physical contact but shorter duration of talking in participants who received AAT using live animals versus robotic animals (median: 93 seconds with live versus 28 seconds with robotic for physical contact; 164 seconds with live versus 206 seconds with robotic for talk directed at a person; 263 seconds with live versus 307 seconds with robotic for talk in total). Another study showed no clear differences between groups in behaviour measured using the Neuropsychiatric Inventory (MD –6.96, 95% CI –14.58 to 0.66; 78 participants; low-certainty evidence) or quality of life (MD –2.42, 95% CI –5.71 to 0.87; 78 participants; low-certainty evidence). There were no data on the other outcomes.\nComparing AAT using live animals versus a soft toy cat, one study (64 participants) evaluated only social functioning, in the form of duration of contact and talking. The data were expressed as median and interquartile ranges. Duration of contact was slightly longer in participants in the AAT group and duration of talking slightly longer in those exposed to the toy cat. This was low-certainty evidence.\nAuthors' conclusions\nWe found low-certainty evidence that AAT may slightly reduce depressive symptoms in people with dementia. We found no clear evidence that AAT affects other outcomes in this population, with our certainty in the evidence ranging from very-low to moderate depending on the outcome. We found no evidence on safety or effects on the animals. Therefore, clear conclusions cannot yet be drawn about the overall benefits and risks of AAT in people with dementia. Further well-conducted RCTs are needed to improve the certainty of the evidence. In view of the difficulty in achieving blinding of participants and personnel in such trials, future RCTs should work on blinding outcome assessors, document allocation methods clearly, and include major patient-important outcomes such as affect, emotional and social functioning, quality of life, adverse events, and outcomes for animals.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases to September 2019."
}
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query-laysum | 2434 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy (DR) is characterised by neurovascular degeneration as a result of chronic hyperglycaemia. Proliferative diabetic retinopathy (PDR) is the most serious complication of DR and can lead to total (central and peripheral) visual loss. PDR is characterised by the presence of abnormal new blood vessels, so-called “new vessels,” at the optic disc (NVD) or elsewhere in the retina (NVE). PDR can progress to high-risk characteristics (HRC) PDR (HRC-PDR), which is defined by the presence of NVD more than one-fourth to one-third disc area in size plus vitreous haemorrhage or pre-retinal haemorrhage, or vitreous haemorrhage or pre-retinal haemorrhage obscuring more than one disc area. In severe cases, fibrovascular membranes grow over the retinal surface and tractional retinal detachment with sight loss can occur, despite treatment. Although most, if not all, individuals with diabetes will develop DR if they live long enough, only some progress to the sight-threatening PDR stage.\nObjectives\nTo determine risk factors for the development of PDR and HRC-PDR in people with diabetes and DR.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5), Ovid MEDLINE, and Ovid Embase. The date of the search was 27 May 2022. Additionally, the search was supplemented by screening reference lists of eligible articles. There were no restrictions to language or year of publication.\nSelection criteria\nWe included prospective or retrospective cohort studies and case-control longitudinal studies evaluating prognostic factors for the development and progression of PDR, in people who have not had previous treatment for DR. The target population consisted of adults (≥18 years of age) of any gender, sexual orientation, ethnicity, socioeconomic status, and geographical location, with non-proliferative diabetic retinopathy (NPDR) or PDR with less than HRC-PDR, diagnosed as per standard clinical practice. Two review authors independently screened titles and abstracts, and full-text articles, to determine eligibility; discrepancies were resolved through discussion. We considered prognostic factors measured at baseline and any other time points during the study and in any clinical setting. Outcomes were evaluated at three and eight years (± two years) or lifelong.\nData collection and analysis\nTwo review authors independently extracted data from included studies using a data extraction form that we developed and piloted prior to the data collection stage. We resolved any discrepancies through discussion. We used the Quality in Prognosis Studies (QUIPS) tool to assess risk of bias. We conducted meta-analyses in clinically relevant groups using a random-effects approach. We reported hazard ratios (HR), odds ratios (OR), and risk ratios (RR) separately for each available prognostic factor and outcome, stratified by different time points. Where possible, we meta-analysed adjusted prognostic factors. We evaluated the certainty of the evidence with an adapted version of the GRADE framework.\nMain results\nWe screened 6391 records. From these, we identified 59 studies (87 articles) as eligible for inclusion. Thirty-five were prospective cohort studies, 22 were retrospective studies, 18 of which were cohort and six were based on data from electronic registers, and two were retrospective case-control studies. Twenty-three studies evaluated participants with type 1 diabetes (T1D), 19 with type 2 diabetes (T2D), and 17 included mixed populations (T1D and T2D). Studies on T1D included between 39 and 3250 participants at baseline, followed up for one to 45 years. Studies on T2D included between 100 and 71,817 participants at baseline, followed up for one to 20 years. The studies on mixed populations of T1D and T2D ranged from 76 to 32,553 participants at baseline, followed up for four to 25 years.\nWe found evidence indicating that higher glycated haemoglobin (haemoglobin A1c (HbA1c)) levels (adjusted OR ranged from 1.11 (95% confidence interval (CI) 0.93 to 1.32) to 2.10 (95% CI 1.64 to 2.69) and more advanced stages of retinopathy (adjusted OR ranged from 1.38 (95% CI 1.29 to 1.48) to 12.40 (95% CI 5.31 to 28.98) are independent risk factors for the development of PDR in people with T1D and T2D. We rated the evidence for these factors as of moderate certainty because of moderate to high risk of bias in the studies.\nThere was also some evidence suggesting several markers for renal disease (for example, nephropathy (adjusted OR ranged from 1.58 (95% CI not reported) to 2.68 (2.09 to 3.42), and creatinine (adjusted meta-analysis HR 1.61 (95% CI 0.77 to 3.36)), and, in people with T1D, age at diagnosis of diabetes (< 12 years of age) (standardised regression estimate 1.62, 95% CI 1.06 to 2.48), increased triglyceride levels (adjusted RR 1.55, 95% CI 1.06 to 1.95), and larger retinal venular diameters (RR 4.28, 95% CI 1.50 to 12.19) may increase the risk of progression to PDR. The certainty of evidence for these factors, however, was low to very low, due to risk of bias in the included studies, inconsistency (lack of studies preventing the grading of consistency or variable outcomes), and imprecision (wide CIs). There was no substantial and consistent evidence to support duration of diabetes, systolic or diastolic blood pressure, total cholesterol, low- (LDL) and high- (HDL) density lipoproteins, gender, ethnicity, body mass index (BMI), socioeconomic status, or tobacco and alcohol consumption as being associated with incidence of PDR. There was insufficient evidence to evaluate prognostic factors associated with progression of PDR to HRC-PDR.\nAuthors' conclusions\nIncreased HbA1c is likely to be associated with progression to PDR; therefore, maintaining adequate glucose control throughout life, irrespective of stage of DR severity, may help to prevent progression to PDR and risk of its sight-threatening complications. Renal impairment in people with T1D or T2D, as well as younger age at diagnosis of diabetes mellitus (DM), increased triglyceride levels, and increased retinal venular diameters in people with T1D may also be associated with increased risk of progression to PDR. Given that more advanced DR severity is associated with higher risk of progression to PDR, the earlier the disease is identified, and the above systemic risk factors are controlled, the greater the chance of reducing the risk of PDR and saving sight.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included studies in which people with diabetes, who had never been treated for diabetic retinopathy, were followed up over time to determine who developed PDR and who progressed to severe stages of PDR (called 'high-risk characteristics PDR' (HRC-PDR)). To be included in our review, these studies had to investigate risk factors for PDR and HRC-PDR: for example, blood sugar, blood pressure, cholesterol, and kidney disease, amongst others. We included studies looking at adults (18 years of age and older) of any gender, ethnicity, sexual orientation, socioeconomic status, and nation, written in any language, in this review."
}
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query-laysum | 2435 | [
{
"role": "user",
"content": "Abstract: Background\nMedical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques, and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis, the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date.\nObjectives\nTo assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above).\nSearch methods\nWe performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April 2020.\nSelection criteria\nWe included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting.\nData collection and analysis\nAt least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome.\nMain results\nEighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda and Zimbabwe.\nPrimary outcomes\nSerious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants).\nModerate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I²= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study limitations and imprecision.\nSecondary outcomes\nMild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I² = 91%; 10 trials, 3370 participants; very low-certainty evidence). We downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency.\nOperative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques, which constitutes a clinically meaningful decrease in a procedure (MD –17.26 minutes, 95% CI –19.96 to –14.57; I² = 99%; 14 trials, 4812 participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard surgical technique generally takes about 24 minutes.\nThere may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I² = 99%; 9 trials, 3022 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity. There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I² = 94%; 4 trials, 1430 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS indicates greater pain.\nParticipants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I² = 97%; 15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction.\nAuthors' conclusions\nWe found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques, but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients, use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.\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": "After a wide search of the literature, we found 18 clinical trials including 5246 males. We looked at information from trials that compared surgical and device-based circumcision procedures. We compared the complications (negative experiences) that patients had after the circumcision; the amount of time a healthcare provider took to do the circumcision; patient's pain during the day after the procedure and one week afterwards; and the amount of satisfaction patients felt with the procedure."
}
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query-laysum | 2436 | [
{
"role": "user",
"content": "Abstract: Background\nWilson's disease, first described by Samuel Wilson in 1912, is an autosomal recessive metabolic disorder resulting from mutations in the ATP7B gene. The disease develops as a consequence of copper accumulating in affected tissues.\nThere is no gold standard for the diagnosis of Wilson's disease, which is often delayed due to the non-specific clinical features and the need for a combination of clinical and laboratory tests for diagnosis. This delay may in turn affect clinical outcome and has implications for other family members in terms of diagnosis. The Leipzig criteria were established to help standardise diagnosis and management. However, it should be emphasised that these criteria date from 2003, and many of these have not been formally evaluated; this review examines the evidence behind biochemical testing for Wilson's disease.\nObjectives\nTo determine the diagnostic accuracy of three biochemical tests at specified cut-off levels for Wilson's disease. The index tests covered by this Cochrane Review are caeruloplasmin, 24-hour urinary copper and hepatic copper content. These tests were evaluated in those with suspected Wilson's disease and appropriate controls (either healthy or those with chronic liver disease other than Wilson's). In the absence of a gold standard for diagnosing Wilson's disease, we have used the Leipzig criteria as a clinical reference standard.\nTo investigate whether index tests should be performed in all individuals who have been recommended for testing for Wilson's disease, or whether these tests should be limited to subgroups of individuals.\nSearch methods\nWe identified studies by extensive searching of, e.g. the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, the Web of Science and clinical trial registries (29 May 2019).\nDate of the most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Inborn Errors of Metabolism Register: 29 May 2019.\nSelection criteria\nWe included prospective and retrospective cohort studies that assessed the diagnostic accuracy of an index test using the Leipzig criteria as a clinical reference standard for the diagnosis of Wilson's disease.\nData collection and analysis\nTwo review authors independently reviewed and extracted data and assessed the methodological quality of each included study using the QUADAS-2 tool. We had planned to undertake meta-analyses of the sensitivity, specificity at relevant cut-offs for each of the biochemical tests for Wilson's, however, due to differences in the methods used for each biochemical index test, it was not possible to combine the results in meta-analyses and hence these are described narratively.\nMain results\nEight studies, involving 5699 participants (which included 1009 diagnosed with Wilson's disease) were eligible for inclusion in the review. Three studies involved children only, one adults only and the four remaining studies involved both children and adults. Two evaluated participants with hepatic signs and six with a combination of hepatic and neurological signs and symptoms of Wilson's disease, as well as pre-symptomatic individuals. The studies were of variable methodological quality; with high risk if bias for participant selection and the reference standard used being of greatest methodological concern. Key differences between studies include differences in assay methodology, different cut-off values for diagnostic thresholds, different age and ethnicity groups. Concerns around study design imply that diagnostic accuracy figures may not transfer to populations outside of the relevant study.\nIndex test: caeruloplasmin\nFive studies evaluated various thresholds of caeruloplasmin (4281 participants, of which 541 had WD). For caeruloplasmin a cut-off of 0.2 g/L as in the Leipzig criteria achieved a sensitivity of 77.1% to 99%, with variable specificity of 55.9% to 82.8%. Using the cut-off of 0.1 g/L of the Leipzig criteria seemed to lower the sensitivity overall, 65% to 78.9%, while increasing the specificity to 96.6% to 100%.\nIndex test: hepatic copper\nFour studies evaluated various thresholds of hepatic copper (1150 participants, of which 367 had WD). The hepatic copper cut-off of 4 μmol/g used in the Leipzig criteria achieved a sensitivity of 65.7% to 94.4%, with a variable specificity of 52.2% to 98.6%.\nIndex test: 24-hour urinary copper\nThree studies evaluated various thresholds of 24-hour urinary copper (268 participants, of which 101 had WD). For 24-hour urinary copper, a cut-off of 0.64 to 1.6 μmol/24 hours used in the Leipzig criteria achieved a variable sensitivity of 50.0% to 80.0%, with a specificity of 75.6% to 98.3%.\nAuthors' conclusions\nThe cut-offs used for caeruloplasmin, 24-hour urinary copper and hepatic copper for diagnosing Wilson's disease are method-dependent and require validation in the population in which such index tests are going to be used. Binary cut-offs and use of single-test strategies to rule Wilson's disease in or out is not supported by the evidence in this review. There is insufficient evidence to inform testing in specific subgroups, defined by age, ethnicity or clinical subgroups.\n\nGiven the provided abstract, please respond to the following query: \"Why is improving Wilson's disease diagnosis important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Wilson's disease is an inherited disease that leads to a build-up of copper in affected parts of the body. Diagnosis usually occurs in children or young adults, but has been seen in adults over 60 years of age. Copper build-up begins in the liver progressing over time to affect the brain; however, the challenge for doctors is that liver disease in Wilson's disease has non-specific features and standard liver blood tests may be normal, even with advanced scarring of the liver or cirrhosis. Early diagnosis allows earlier treatment, however, other causes of chronic liver disease may cause false-positive results and, depending on cut-off values used for testing, may result in further unnecessary testing. Conversely, false-negative results may also arise when a single-test strategy for diagnosis is used, possibly leading to a delay in treatment."
}
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query-laysum | 2437 | [
{
"role": "user",
"content": "Abstract: Background\nPatients in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as increased patient care activities and invasive monitoring as part of their care. Sleep deprivation affects physical and psychological health, and patients perceive the quality of their sleep to be poor whilst in the ICU. Artificial lighting during night-time hours in the ICU may contribute to reduced production of melatonin in critically ill patients. Melatonin is known to have a direct effect on the circadian rhythm, and it appears to reset a natural rhythm, thus promoting sleep.\nObjectives\nTo assess whether the quantity and quality of sleep may be improved by administration of melatonin to adults in the intensive care unit. To assess whether melatonin given for sleep promotion improves both physical and psychological patient outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), MEDLINE (1946 to September 2017), Embase (1974 to September 2017), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to September 2017), and PsycINFO (1806 to September 2017). We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials with adult participants (over the age of 16) admitted to the ICU with any diagnoses given melatonin versus a comparator to promote overnight sleep. We included participants who were mechanically ventilated and those who were not mechanically ventilated. We planned to include studies that compared the use of melatonin, given at an appropriate clinical dose with the intention of promoting night-time sleep, against no agent; or against another agent administered specifically to promote sleep.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, assessed risk of bias, and synthesized findings. We assessed the quality of evidence with GRADE.\nMain results\nWe included four studies with 151 randomized participants. Two studies included participants who were mechanically ventilated, one study included a mix of ventilated and non-ventilated participants and in one study participants were being weaned from mechanical ventilation. Three studies reported admission diagnoses, which varied: these included sepsis, pneumonia and cardiac or cardiorespiratory arrest. All studies compared melatonin against no agent; three were placebo-controlled trials; and one compared melatonin with usual care. All studies administered melatonin in the evening.\nAll studies reported adequate methods for randomization and placebo-controlled trials were blinded at the participant and personnel level. We noted high risk of attrition bias in one study and were unclear about potential bias introduced in two studies with differences between participants at baseline.\nIt was not appropriate to combine data owing to differences in measurement tools, or methods used to report data.\nThe effects of melatonin on subjectively rated quantity and quality of sleep are uncertain (very low certainty evidence). Three studies (139 participants) reported quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments. Study authors in one study reported no difference in sleep efficiency index scores between groups for participant assessment (using Richards-Campbell Sleep Questionnaire) and nurse assessment. Two studies reported no difference in duration of sleep observed by nurses.\nThe effects of melatonin on objectively measured quantity and quality of sleep are uncertain (very low certainty evidence). Two studies (37 participants) reported quantity and quality of sleep as measured by polysomnography (PSG), actigraphy, bispectral index (BIS) or electroencephalogram (EEG). Study authors in one study reported no difference in sleep efficiency index scores between groups using BIS and actigraphy. These authors also reported longer sleep in participants given melatonin which was not statistically significant, and improved sleep (described as \"better sleep\") in participants given melatonin from analysis of area under the curve (AUC) of BIS data. One study used PSG but authors were unable to report data because of a large loss of participant data.\nOne study (82 participants) reported no evidence of a difference in anxiety scores (very low certainty evidence). Two studies (94 participants) reported data for mortality: one study reported that overall one-third of participants died; and one study reported no evidence of difference between groups in hospital mortality (very low certainty). One study (82 participants) reported no evidence of a difference in length of ICU stay (very low certainty evidence). Effects of melatonin on adverse events were reported in two studies (107 participants), and are uncertain (very low certainty evidence): one study reported headache in one participant given melatonin, and one study reported excessive sleepiness in one participant given melatonin and two events in the control group (skin reaction in one participant, and excessive sleepiness in another participant).\nThe certainty of the evidence for each outcome was limited by sparse data with few participants. We noted study limitations in some studies due to high attrition and differences between groups in baseline data; and doses of melatonin varied between studies. Methods used to measure data were not consistent for outcomes, and use of some measurement tools may not be effective for use on the ICU patient. All studies included participants in the ICU but we noted differences in ICU protocols, and one included study used a non-standard sedation protocol with participants which introduced indirectness to the evidence.\nAuthors' conclusions\nWe found insufficient evidence to determine whether administration of melatonin would improve the quality and quantity of sleep in ICU patients. We identified sparse data, and noted differences in study methodology, in ICU sedation protocols, and in methods used to measure and report sleep. We identified five ongoing studies from database and clinical trial register searches. Inclusion of data from these studies in future review updates would provide more certainty for the review outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To assess whether melatonin improves the quantity and quality of sleep for adults in the ICU and improves physical and psychological health."
}
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query-laysum | 2438 | [
{
"role": "user",
"content": "Abstract: Background\nAnticoagulation may improve survival in patients with cancer through a speculated anti-tumour effect, in addition to the antithrombotic effect, although may increase the risk of bleeding.\nObjectives\nTo evaluate the efficacy and safety of parenteral anticoagulants in ambulatory patients with cancer who, typically, are undergoing chemotherapy, hormonal therapy, immunotherapy or radiotherapy, but otherwise have no standard therapeutic or prophylactic indication for anticoagulation.\nSearch methods\nA comprehensive search included (1) a major electronic search (February 2016) of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 1), MEDLINE (1946 to February 2016; accessed via OVID) and Embase (1980 to February 2016; accessed via OVID); (2) handsearching of conference proceedings; (3) checking of references of included studies; (4) use of the 'related citation' feature in PubMed and (5) a search for ongoing studies in trial registries. As part of the living systematic review approach, we are running searches continually and we will incorporate new evidence rapidly after it is identified. This update of the systematic review is based on the findings of a literature search conducted on 14 August 2017.\nSelection criteria\nRandomized controlled trials (RCTs) assessing the benefits and harms of parenteral anticoagulation in ambulatory patients with cancer. Typically, these patients are undergoing chemotherapy, hormonal therapy, immunotherapy or radiotherapy, but otherwise have no standard therapeutic or prophylactic indication for anticoagulation.\nData collection and analysis\nUsing a standardized form we extracted data in duplicate on study design, participants, interventions outcomes of interest, and risk of bias. Outcomes of interested included all-cause mortality, symptomatic venous thromboembolism (VTE), symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), major bleeding, minor bleeding, and quality of life. We assessed the certainty of evidence for each outcome using the GRADE approach (GRADE handbook [GRADE handbook]).\nMain results\nOf 6947 identified citations, 19 RCTs fulfilled the eligibility criteria. These trials enrolled 9650 participants. Trial registries' searches identified nine registered but unpublished trials, two of which were labeled as 'ongoing trials'. In all included RCTs, the intervention consisted of heparin (either unfractionated heparin or low molecular weight heparin). Overall, heparin appears to have no effect on mortality at 12 months (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.93 to 1.03; risk difference (RD) 10 fewer per 1000; 95% CI 35 fewer to 15 more; moderate certainty of evidence) and mortality at 24 months (RR 0.99; 95% CI 0.96 to 1.01; RD 8 fewer per 1000; 95% CI 31 fewer to 8 more; moderate certainty of evidence). Heparin therapy reduces the risk of symptomatic VTE (RR 0.56; 95% CI 0.47 to 0.68; RD 30 fewer per 1000; 95% CI 36 fewer to 22 fewer; high certainty of evidence), while it increases in the risks of major bleeding (RR 1.30; 95% 0.94 to 1.79; RD 4 more per 1000; 95% CI 1 fewer to 11 more; moderate certainty of evidence) and minor bleeding (RR 1.70; 95% 1.13 to 2.55; RD 17 more per 1000; 95% CI 3 more to 37 more; high certainty of evidence). Results failed to confirm or to exclude a beneficial or detrimental effect of heparin on thrombocytopenia (RR 0.69; 95% CI 0.37 to 1.27; RD 33 fewer per 1000; 95% CI 66 fewer to 28 more; moderate certainty of evidence); quality of life (moderate certainty of evidence).\nAuthors' conclusions\nHeparin appears to have no effect on mortality at 12 months and 24 months. It reduces symptomatic VTE and likely increases major and minor bleeding. Future research should further investigate the survival benefit of different types of anticoagulants in patients with different types and stages of cancer. The decision for a patient with cancer to start heparin therapy should balance the benefits and downsides, and should integrate the patient's values and preferences.\nEditorial note:This is a living systematic review. Living systematic reviews offer a new approach to review updating in which the review is continually updated, incorporating relevant new evidence, as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status 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": "We selected 19 trials including 9650 participants with cancer. Most trials included participants with various types of cancer, especially small cell lung cancer, non-small cell lung cancer, and pancreatic cancer. All studies were conducted in the outpatient setting. The results suggest that the effect of injectable blood thinners on survival is uncertain, but if anything of small size. Also the results suggest that injectable blood thinners reduce the risk of blood clots by about half and possibly increase the risk of major bleeding and minor bleeding by 4 more per 1000 and 17 more per 1000, respectively. The effect on quality of life is uncertain."
}
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query-laysum | 2439 | [
{
"role": "user",
"content": "Abstract: Background\nPost-traumatic stress disorder (PTSD) is a debilitating mental health disorder that may develop after exposure to traumatic events. Substance use disorder (SUD) is a behavioural disorder in which the use of one or more substances is associated with heightened levels of distress, clinically significant impairment of functioning, or both. PTSD and SUD frequently occur together. The comorbidity is widely recognised as being difficult to treat and is associated with poorer treatment completion and poorer outcomes than for either condition alone. Several psychological therapies have been developed to treat the comorbidity, however there is no consensus about which therapies are most effective.\nObjectives\nTo determine the efficacy of psychological therapies aimed at treating traumatic stress symptoms, substance misuse symptoms, or both in people with comorbid PTSD and SUD in comparison with control conditions (usual care, waiting-list conditions, and no treatment) and other psychological therapies.\nSearch methods\nWe searched the Cochrane Depression, Anxiety and Neurosis Group’s Specialised Register (CCDANCTR) all years to 11 March 2015. This register contains relevant randomised controlled trials from the Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov, contacted experts, searched bibliographies of included studies, and performed citation searches of identified articles.\nSelection criteria\nRandomised controlled trials of individual or group psychological therapies delivered to individuals with PTSD and comorbid substance use, compared with waiting-list conditions, usual care, or minimal intervention or to other psychological therapies.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 14 studies with 1506 participants, of which 13 studies were included in the quantitative synthesis. Most studies involved adult populations. Studies were conducted in a variety of settings. We performed four comparisons investigating the effects of psychological therapies with a trauma-focused component and non-trauma-focused interventions against treatment as usual/minimal intervention and other active psychological therapies. Comparisons were stratified for individual- or group-based therapies. All active interventions were based on cognitive behavioural therapy. Our main findings were as follows.\nIndividual-based psychological therapies with a trauma-focused component plus adjunctive SUD intervention was more effective than treatment as usual (TAU)/minimal intervention for PTSD severity post-treatment (standardised mean difference (SMD) -0.41; 95% confidence interval (CI) -0.72 to -0.10; 4 studies; n = 405; very low-quality evidence) and at 3 to 4 and 5 to 7 months' follow-up. There was no evidence of an effect for level of drug/alcohol use post-treatment (SMD -0.13; 95% CI -0.41 to 0.15; 3 studies; n = 388; very low-quality evidence), but there was a small effect in favour of individual psychological therapy at 5 to 7 months (SMD -0.28; 95% CI -0.48 to -0.07; 3 studies; n = 388) when compared against TAU. Fewer participants completed trauma-focused therapy than TAU (risk ratio (RR) 0.78; 95% CI 0.64 to 0.96; 3 studies; n = 316; low-quality evidence).\nIndividual-based psychological therapy with a trauma-focused component did not perform better than psychological therapy for SUD only for PTSD severity (mean difference (MD) -3.91; 95% CI -19.16 to 11.34; 1 study; n = 46; low-quality evidence) or drug/alcohol use (MD -1.27; 95% CI -5.76 to 3.22; 1 study; n = 46; low-quality evidence). Findings were based on one small study. No effects were observed for rates of therapy completion (RR 1.00; 95% CI 0.74 to 1.36; 1 study; n = 62; low-quality evidence).\nNon-trauma-focused psychological therapies did not perform better than TAU/minimal intervention for PTSD severity when delivered on an individual (SMD -0.22; 95% CI -0.83 to 0.39; 1 study; n = 44; low-quality evidence) or group basis (SMD -0.02; 95% CI -0.19 to 0.16; 4 studies; n = 513; low-quality evidence). There were no data on the effects on drug/alcohol use for individual therapy. There was no evidence of an effect on the level of drug/alcohol use for group-based therapy (SMD -0.03; 95% CI -0.37 to 0.31; 4 studies; n = 414; very low-quality evidence). A post-hoc analysis for full dose of a widely established group therapy called Seeking Safety showed reduced drug/alcohol use post-treatment (SMD -0.67; 95% CI -1.14 to -0.19; 2 studies; n = 111), but not at subsequent follow-ups. Data on the number of participants completing therapy were not for individual-based therapy. No effects were observed for rates of therapy completion for group-based therapy (RR 1.13; 95% CI 0.88 to 1.45; 2 studies; n = 217; low-quality evidence).\nNon-trauma-focused psychological therapy did not perform better than psychological therapy for SUD only for PTSD severity (SMD -0.26; 95% CI -1.29 to 0.77; 2 studies; n = 128; very low-quality evidence) or drug/alcohol use (SMD 0.22; 95% CI -0.13 to 0.57; 2 studies; n = 128; low-quality evidence). No effects were observed for rates of therapy completion (RR 0.91; 95% CI 0.68 to 1.20; 2 studies; n = 128; very low-quality evidence).\nSeveral studies reported on adverse events. There were no differences between rates of such events in any comparison. We rated several studies as being at 'high' or 'unclear' risk of bias in multiple domains, including for detection bias and attrition bias.\nAuthors' conclusions\nWe assessed the evidence in this review as mostly low to very low quality. Evidence showed that individual trauma-focused psychological therapy delivered alongside SUD therapy did better than TAU/minimal intervention in reducing PTSD severity post-treatment and at long-term follow-up, but only reduced SUD at long-term follow-up. All effects were small, and follow-up periods were generally quite short. There was evidence that fewer participants receiving trauma-focused therapy completed treatment. There was very little evidence to support use of non-trauma-focused individual- or group-based integrated therapies. Individuals with more severe and complex presentations (e.g. serious mental illness, individuals with cognitive impairment, and suicidal individuals) were excluded from most studies in this review, and so the findings from this review are not generalisable to such individuals. Some studies suffered from significant methodological problems and some were underpowered, limiting the conclusions that can be drawn. Further research is needed in this area.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence showed that individual trauma-focused psychological therapy delivered alongside SUD therapies was more effective in reducing PTSD compared to treatment as usual. This result was found both straight after treatment and at long-term follow-up. However, SUD severity only declined at long-term follow-up. More people dropped out of the trauma-focused therapy compared with treatment as usual. Overall, the benefits of trauma-focused treatment were small.\nWe found little evidence for the benefit of individual- or group-based non-trauma-focused psychological therapies. For group-based therapies, we found that substance use was reduced post-treatment when participants were offered a full course of 25 sessions of the therapy 'Seeking Safety', which was delivered in a group setting. However, this positive effect did not continue at later follow-up points. The level of drop-out was high across all studies.\nWe graded the quality of evidence as low to very low. This review includes a small number of studies. Some included studies were poorly designed, and most studies were small. There was also considerable variation in the way that the therapies and control therapies were delivered. It is likely that participants in the included studies received a range of other stabilising interventions alongside trauma-focused treatment, and we found no evidence to support the delivery of trauma-focused therapies without SUD-focused therapies. It is therefore possible that our findings will change as further evidence of higher quality is accumulated. Healthcare providers should exercise caution when considering whether to provide therapies described in this review."
}
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query-laysum | 2440 | [
{
"role": "user",
"content": "Abstract: Background\nSystematic reviews showed that systemic postnatal corticosteroids reduce the risk of bronchopulmonary dysplasia (BPD) in preterm infants. However, corticosteroids have also been associated with an increased risk of neurodevelopmental impairment. It is unknown whether these beneficial and adverse effects are modulated by differences in corticosteroid treatment regimens related to type of steroid, timing of treatment initiation, duration, pulse versus continuous delivery, and cumulative dose.\nObjectives\nTo assess the effects of different corticosteroid treatment regimens on mortality, pulmonary morbidity, and neurodevelopmental outcome in very low birth weight infants.\nSearch methods\nWe conducted searches in September 2022 of MEDLINE, the Cochrane Library, Embase, and two trial registries, without date, language or publication- type limits. Other search methods included checking the reference lists of included studies for randomized controlled trials (RCTs) and quasi-randomized trials.\nSelection criteria\nWe included RCTs comparing two or more different treatment regimens of systemic postnatal corticosteroids in preterm infants at risk for BPD, as defined by the original trialists. The following comparisons of intervention were eligible: alternative corticosteroid (e.g. hydrocortisone) versus another corticosteroid (e.g. dexamethasone); lower (experimental arm) versus higher dosage (control arm); later (experimental arm) versus earlier (control arm) initiation of therapy; a pulse-dosage (experimental arm) versus continuous-dosage regimen (control arm); and individually-tailored regimens (experimental arm) based on the pulmonary response versus a standardized (predetermined administered to every infant) regimen (control arm). We excluded placebo-controlled and inhalation corticosteroid studies.\nData collection and analysis\nTwo authors independently assessed eligibility and risk of bias of trials, and extracted data on study design, participant characteristics and the relevant outcomes. We asked the original investigators to verify if data extraction was correct and, if possible, to provide any missing data. We assessed the following primary outcome: the composite outcome mortality or BPD at 36 weeks' postmenstrual age (PMA). Secondary outcomes were: the components of the composite outcome; in-hospital morbidities and pulmonary outcomes, and long-term neurodevelopmental sequelae. We analyzed data using Review Manager 5 and used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 16 studies in this review; of these, 15 were included in the quantitative synthesis. Two trials investigated multiple regimens, and were therefore included in more than one comparison. Only RCTs investigating dexamethasone were identified.\nEight studies enrolling a total of 306 participants investigated the cumulative dosage administered; these trials were categorized according to the cumulative dosage investigated, 'low' being < 2 mg/kg, 'moderate' being between 2 and 4 mg/kg, and 'high' > 4 mg/kg; three studies contrasted a high versus a moderate cumulative dose, and five studies a moderate versus a low cumulative dexamethasone dose. We graded the certainty of the evidence low to very low because of the small number of events, and the risk of selection, attrition and reporting bias. Overall analysis of the studies investigating a higher dose versus a lower dosage regimen showed no differences in the outcomes BPD, the composite outcome death or BPD at 36 weeks' PMA, or abnormal neurodevelopmental outcome in survivors assessed. Although there was no evidence of a subgroup difference for the higher versus lower dosage regimens comparisons (Chi2 = 2.91, df = 1 (P = 0.09), I2 = 65.7%), a larger effect was seen in the subgroup analysis of moderate-dosage regimens versus high-dosage regimens for the outcome cerebral palsy in survivors. In this subgroup analysis, there was an increased risk of cerebral palsy (RR 6.85, 95% CI 1.29 to 36.36; RD 0.23, 95% CI 0.08 to 0.37; P = 0.02; I² = 0%; NNTH 5, 95% CI 2.6 to 12.7; 2 studies, 74 infants). There was evidence of subgroup differences for higher versus lower dosage regimens comparisons for the combined outcomes death or cerebral palsy, and death and abnormal neurodevelopmental outcomes (Chi2 = 4.25, df = 1 (P = 0.04), I2 = 76.5%; and Chi2 = 7.11, df = 1 (P = 0.008), I2 = 85.9%, respectively). In the subgroup analysis comparing a high dosage regimen of dexamethasone versus a moderate cumulative-dosage regimen, there was an increased risk of death or cerebral palsy (RR 3.20, 95% CI 1.35 to 7.58; RD 0.25, 95% CI 0.09 to 0.41; P = 0.002; I² = 0%; NNTH 5, 95% CI 2.4 to 13.6; 2 studies, 84 infants; moderate-certainty evidence), and death or abnormal neurodevelopmental outcome (RR 3.41, 95% CI 1.44 to 8.07; RD 0.28, 95% CI 0.11 to 0.44; P = 0.0009; I² = 0%; NNTH 4, 95% CI 2.2 to 10.4; 2 studies, 84 infants; moderate-certainty evidence). There were no differences in outcomes between a moderate- and a low-dosage regimen.\nFive studies enrolling 797 infants investigated early initiation of dexamethasone therapy versus a moderately early or delayed initiation, and showed no significant differences in the overall analyses for the primary outcomes. The two RCTs investigating a continuous versus a pulse dexamethasone regimen showed an increased risk of the combined outcome death or BPD when using the pulse therapy. Finally, three trials investigating a standard regimen versus a participant-individualized course of dexamethasone showed no difference in the primary outcome and long-term neurodevelopmental outcomes.\nWe assessed the GRADE certainty of evidence for all comparisons discussed above as moderate to very low, because the validity of all comparisons is hampered by unclear or high risk of bias, small samples of randomized infants, heterogeneity in study population and design, non-protocolized use of ‘rescue’ corticosteroids and lack of long-term neurodevelopmental data in most studies.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of different corticosteroid regimens on the outcomes mortality, pulmonary morbidity, and long term neurodevelopmental impairment. Despite the fact that the studies investigating higher versus lower dosage regimens showed that higher-dosage regimens may reduce the incidence of death or neurodevelopmental impairment, we cannot conclude what the optimal type, dosage, or timing of initiation is for the prevention of BPD in preterm infants, based on current level of evidence. Further high quality trials would be needed to establish the optimal systemic postnatal corticosteroid dosage regimen.\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 very limited confidence in the evidence, because most of the studies had limitations in study design. Most studies had a small sample size, and there were considerable differences between the studies that made it hard to compare them. Most of the studies were too short to provide information on the babies' longer-term development. Therefore, it is not very well known what the best course of therapy is to prevent BPD."
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query-laysum | 2441 | [
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"role": "user",
"content": "Abstract: Background\nDespite the widespread use of antenatal corticosteroids to prevent respiratory distress syndrome (RDS) in preterm infants, there is currently no consensus as to the type of corticosteroid to use, dose, frequency, timing of use or the route of administration.\nObjectives\nTo assess the effects on fetal and neonatal morbidity and mortality, on maternal morbidity and mortality, and on the child and adult in later life, of administering different types of corticosteroids (dexamethasone or betamethasone), or different corticosteroid dose regimens, including timing, frequency and mode of administration.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 May 2022) and reference lists of retrieved studies.\nSelection criteria\nWe included all identified published and unpublished randomised controlled trials or quasi-randomised controlled trials comparing any two corticosteroids (dexamethasone or betamethasone or any other corticosteroid that can cross the placenta), comparing different dose regimens (including frequency and timing of administration) in women at risk of preterm birth. We planned to exclude cross-over trials and cluster-randomised trials. We planned to include studies published as abstracts only along with studies published as full-text manuscripts.\nData collection and analysis\nAt least two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 11 trials (2494 women and 2762 infants) in this update, all of which recruited women who were at increased risk of preterm birth or had a medical indication for preterm birth. All trials were conducted in high-income countries.\nDexamethasone versus betamethasone\nNine trials (2096 women and 2319 infants) compared dexamethasone versus betamethasone. All trials administered both drugs intramuscularly, and the total dose in the course was consistent (22.8 mg or 24 mg), but the regimen varied. We assessed one new study to have no serious risk of bias concerns for most outcomes, but other studies were at moderate (six trials) or high (two trials) risk of bias due to selection, detection and attrition bias. Our GRADE assessments ranged between high- and low-certainty, with downgrades due to risk of bias and imprecision.\nMaternal outcomes\nThe only maternal primary outcome reported was chorioamnionitis (death and puerperal sepsis were not reported). Although the rate of chorioamnionitis was lower with dexamethasone, we did not find conclusive evidence of a difference between the two drugs (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.48 to 1.06; 1 trial, 1346 women; moderate-certainty evidence). The proportion of women experiencing maternal adverse effects of therapy was lower with dexamethasone; however, there was not conclusive evidence of a difference between interventions (RR 0.63, 95% CI 0.35 to 1.13; 2 trials, 1705 women; moderate-certainty evidence).\nInfant outcomes\nWe are unsure whether the choice of drug makes a difference to the risk of any known death after randomisation, because the 95% CI was compatible with both appreciable benefit and harm with dexamethasone (RR 1.03, 95% CI 0.66 to 1.63; 5 trials, 2105 infants; moderate-certainty evidence). The choice of drug may make little or no difference to the risk of RDS (RR 1.06, 95% CI 0.91 to 1.22; 5 trials, 2105 infants; high-certainty evidence). While there may be little or no difference in the risk of intraventricular haemorrhage (IVH), there was substantial unexplained statistical heterogeneity in this result (average (a) RR 0.71, 95% CI 0.28 to 1.81; 4 trials, 1902 infants; I² = 62%; low-certainty evidence). We found no evidence of a difference between the two drugs for chronic lung disease (RR 0.92, 95% CI 0.64 to 1.34; 1 trial, 1509 infants; moderate-certainty evidence), and we are unsure of the effects on necrotising enterocolitis, because there were few events in the studies reporting this outcome (RR 5.08, 95% CI 0.25 to 105.15; 2 studies, 441 infants; low-certainty evidence).\nLonger-term child outcomes\nOnly one trial consistently followed up children longer term, reporting at two years' adjusted age. There is probably little or no difference between dexamethasone and betamethasone in the risk of neurodevelopmental disability at follow-up (RR 1.02, 95% CI 0.85 to 1.22; 2 trials, 1151 infants; moderate-certainty evidence). It is unclear whether the choice of drug makes a difference to the risk of visual impairment (RR 0.33, 95% CI 0.01 to 8.15; 1 trial, 1227 children; low-certainty evidence). There may be little or no difference between the drugs for hearing impairment (RR 1.16, 95% CI 0.63 to 2.16; 1 trial, 1227 children; moderate-certainty evidence), motor developmental delay (RR 0.89, 95% CI 0.66 to 1.20; 1 trial, 1166 children; moderate-certainty evidence) or intellectual impairment (RR 0.97, 95% CI 0.79 to 1.20; 1 trial, 1161 children; moderate-certainty evidence). However, the effect estimate for cerebral palsy is compatible with both an important increase in risk with dexamethasone, and no difference between interventions (RR 2.50, 95% CI 0.97 to 6.39; 1 trial, 1223 children; low-certainty evidence).\nNo trials followed the children beyond early childhood.\nComparisons of different preparations and regimens of corticosteroids\nWe found three studies that included a comparison of a different regimen or preparation of either dexamethasone or betamethasone (oral dexamethasone 32 mg versus intramuscular dexamethasone 24 mg; betamethasone acetate plus phosphate versus betamethasone phosphate; 12-hourly betamethasone versus 24-hourly betamethasone). The certainty of the evidence for the main outcomes from all three studies was very low, due to small sample size and risk of bias. Therefore, we were limited in our ability to draw conclusions from any of these studies.\nAuthors' conclusions\nOverall, it remains unclear whether there are important differences between dexamethasone and betamethasone, or between one regimen and another.\nMost trials compared dexamethasone versus betamethasone. While for most infant and early childhood outcomes there may be no difference between these drugs, for several important outcomes for the mother, infant and child the evidence was inconclusive and did not rule out significant benefits or harms.\nThe evidence on different antenatal corticosteroid regimens was sparse, and does not support the use of one particular corticosteroid regimen over another.\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": "Babies born early (before 37 weeks of pregnancy, which is considered preterm birth) are at increased risk of health problems. These include lung problems (respiratory distress syndrome), bleeding of the brain (intraventricular haemorrhage) and death. Medicines called corticosteroids are given to the mother while still pregnant to help stop these problems occurring and there is high-quality evidence that they are effective in preventing many of these issues. These medicines work by maturing the baby's lungs before birth. There are different types of corticosteroid and they can be given in different ways and in different doses. While we know that giving mothers at risk of early birth corticosteroids has benefits for the baby, we do not know which type of corticosteroid is most beneficial and least harmful for mother and baby."
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query-laysum | 2442 | [
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"role": "user",
"content": "Abstract: Background\nPeople who have chronic kidney disease (CKD) have important changes to bone structure, strength, and metabolism. Children experience bone deformity, pain, and delayed or impaired growth. Adults experience limb and vertebral fractures, avascular necrosis, and pain. The fracture risk after kidney transplantation is four times that of the general population and is related to Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) occurring with end-stage kidney failure, steroid-induced bone loss, and persistent hyperparathyroidism after transplantation. Fractures may reduce quality of life and lead to being unable to work or contribute to community roles and responsibilities. Earlier versions of this review have found low certainty evidence for effects of treatment. This is an update of a review first published in 2005 and updated in 2007.\nObjectives\nThis review update evaluates the benefits and harms of interventions for preventing bone disease following kidney transplantation.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 16 May 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRCTs and quasi-RCTs evaluating treatments for bone disease among kidney transplant recipients of any age were eligible.\nData collection and analysis\nTwo authors independently assessed trial risks of bias and extracted data. Statistical analyses were performed using random effects meta-analysis. The risk estimates were expressed as a risk ratio (RR) for dichotomous variables and mean difference (MD) for continuous outcomes together with the corresponding 95% confidence interval (CI). The primary efficacy outcome was bone fracture. The primary safety outcome was acute graft rejection. Secondary outcomes included death (all cause and cardiovascular), myocardial infarction, stroke, musculoskeletal disorders (e.g. skeletal deformity, bone pain), graft loss, nausea, hyper- or hypocalcaemia, kidney function, serum parathyroid hormone (PTH), and bone mineral density (BMD).\nMain results\nIn this 2019 update, 65 studies (involving 3598 participants) were eligible; 45 studies contributed data to our meta-analyses (2698 participants). Treatments included bisphosphonates, vitamin D compounds, teriparatide, denosumab, cinacalcet, parathyroidectomy, and calcitonin. Median duration of follow-up was 12 months. Forty-three studies evaluated bone density or bone-related biomarkers, with more recent studies evaluating proteinuria and hyperparathyroidism. Bisphosphonate therapy was usually commenced in the perioperative transplantation period (within 3 weeks) and regardless of BMD. Risks of bias were generally high or unclear leading to lower certainty in the results. A single study reported outcomes among 60 children and adolescents. Studies were not designed to measure treatment effects on fracture, death or cardiovascular outcomes, or graft loss.\nCompared to placebo, bisphosphonate therapy administered over 12 months in transplant recipients may prevent fracture (RR 0.62, 95% CI 0.38 to 1.01; low certainty evidence) although the 95% CI included the possibility that bisphosphonate therapy might make little or no difference. Fracture events were principally vertebral fractures identified during routine radiographic surveillance. It was uncertain whether any other drug class decreased fracture (low or very low certainty evidence). It was uncertain whether interventions for bone disease in kidney transplantation reduce all-cause or cardiovascular death, myocardial infarction or stroke, or graft loss in very low certainty evidence. Bisphosphonate therapy may decrease acute graft rejection (RR 0.70, 95% CI 0.55 to 0.89; low certainty evidence), while it is uncertain whether any other treatment impacts graft rejection (very low certainty evidence). Bisphosphonate therapy may reduce bone pain (RR 0.20, 95% CI 0.04 to 0.93; very low certainty evidence), while it was very uncertain whether bisphosphonates prevent spinal deformity or avascular bone necrosis (very low certainty evidence). Bisphosphonates may increase to risk of hypocalcaemia (RR 5.59, 95% CI 1.00 to 31.06; low certainty evidence). It was uncertain whether vitamin D compounds had any effect on skeletal, cardiovascular, death, or transplant function outcomes (very low certainty or absence of evidence). Evidence for the benefits and harms of all other treatments was of very low certainty. Evidence for children and young adolescents was sparse.\nAuthors' conclusions\nBisphosphonate therapy may reduce fracture and bone pain after kidney transplantation, however low certainty in the evidence indicates it is possible that treatment may make little or no difference. It is uncertain whether bisphosphonate therapy or other bone treatments prevent other skeletal complications after kidney transplantation, including spinal deformity or avascular bone necrosis. The effects of bone treatment for children and adolescents after kidney transplantation are very uncertain.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We looked for new studies available since our last review published in 2007 to learn whether there is new information about available treatments for bone disease in people who have had a kidney transplant."
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query-laysum | 2443 | [
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"role": "user",
"content": "Abstract: Background\nAsthma is the most common chronic disease in childhood. Breathing exercise techniques have been widely used by researchers and professionals in the search for complementary therapies for the treatment of asthma.\nObjectives\nTo assess the effects of breathing exercises in children with asthma.\nSearch methods\nWe searched for trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL and AMED and handsearched respiratory journals and meeting abstracts. We also consulted trial registers and reference lists of included articles.\nThe literature search was run up to September 2015.\nSelection criteria\nWe included randomised controlled trials of breathing exercises alone versus control or breathing exercises as part of a more complex intervention versus control in children with asthma.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. The primary outcomes were quality of life, asthma symptoms and serious adverse events. The secondary outcomes were reduction in medication usage, number of acute exacerbations, physiological measures (lung function (especially low flow rates) and functional capacity), days off school and adverse events.\nMain results\nThe review included three studies involving 112 participants. All the included studies performed the comparison breathing exercises as part of a more complex intervention versus control. There were no trials comparing breathing exercises alone with control. Asthma severity of participants from the included studies varied. The studies measured: quality of life, asthma symptoms, reduction in medication usage, number of acute exacerbations and lung function. Breathing exercise techniques used by the included studies consisted of lateral costal breathing, diaphragmatic breathing, inspiratory patterns and pursed lips. One study included in the review did not specify the type of breathing exercise used. The control groups received different interventions: one received placebo treatment, one an educational programme and doctor appointments, and one was not described. There were no reported between-group comparisons for any of the primary outcomes. We judged the included studies as having an unclear risk of bias.\nAuthors' conclusions\nWe could draw no reliable conclusions concerning the use of breathing exercises for children with asthma in clinical practice. The breathing exercises were part of a more comprehensive package of care, and could not be assessed on their own. Moreover, there were methodological differences among the three small included studies and poor reporting of methodological aspects and results in most of the included studies.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to look at the evidence for the effects of breathing exercises in children with asthma."
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query-laysum | 2444 | [
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"role": "user",
"content": "Abstract: Background\nUrinary tract infections (UTIs) are very common, affecting more than 7 million people worldwide. Whilst many people may only experience a single episode in their lifetime and are generally responsive to standard antibiotics, a significant proportion of adults and children (approximately 15% to 25%) are chronic symptomatic UTI sufferers. Certain population groups are at greater risk than others, such as immunosuppressed and people with chronic kidney disease.\nD-mannose is a sugar part of normal human metabolism found within most diets. The mechanism of action is to prevent bacterial adherence to the uroepithelial cells. The D-mannose-based inhibitors can block uropathogenic Escherichia coli adhesion and invasion of the uroepithelial cells. The bacteria are then understood to essentially be eliminated by urination.\nEarly pilot studies on animals and humans have trialled concentrated forms of D-mannose (tablets or sachets) in doses ranging from 200 mg up to 2 to 3 g and found possible efficacy in reducing UTI symptoms or recurrence.\nAlthough the anti-adhesive effects of D-mannose have been well-established, only recently have we seen a small number of pilot studies and small clinical trials conducted.\nObjectives\nTo assess the benefits and harms of D-mannose for preventing and treating UTIs in adults and children.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 22 February 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included RCTs measuring and reporting the effect of D-mannose, in any combination and any formulation, to prevent or treat UTIs in adults and children, females and males, in any setting (including perioperative).\nAuthors independently assessed the retrieved titles and abstracts and, where necessary, the full text to determine which satisfied the inclusion criteria.\nData collection and analysis\nData extraction was independently carried out by two authors using a standard data extraction form. Methodological quality of the included studies was assessed using the Cochrane risk of bias tool. Data entry was carried out by one author and cross-checked by another author. The certainty of the evidence was assessed using the GRADE approach.\nMain results\nWe included seven RCTs (719 participants) in adult females and males who had either acute cystitis or a history of recurrent (at least two episodes in six months or three episodes in 12 months) UTIs (symptomatic or asymptomatic). Two were prevention studies, four were prevention and treatment studies (two perioperative and one in people with multiple sclerosis), and one was a treatment study. Time periods ranged from 15 days to six months. No two studies were comparable (by dose or treatments), and we could not undertake meta-analyses.\nIndividual studies reported no clear evidence to determine whether D-mannose is more or less effective in preventing or treating UTIs.\nD-mannose (2 g) had uncertain effects on symptomatic and bacteriuria-confirmed UTIs when compared to no treatment (1 study, 205 participants; very low certainty evidence) and antibiotics (nitrofurantoin 50 mg) (1 study, 206 participants; very low certainty evidence). D-mannose, in combination with herbal supplements, had uncertain effects on symptomatic and bacteria-confirmed UTI and pain when compared to no treatment (1 study, 40 participants; very low certainty evidence). D-mannose 500 mg plus supplements (N-acetylcysteine and Morinda citrifolia fruit extract) had uncertain effects on symptomatic and bacteriuria-confirmed UTIs when compared to an antibiotic (prulifloxacin 400 mg) (1 study, 75 participants; very low certainty evidence).\nAdverse events were very few and poorly reported; none were serious (mostly diarrhoea and vaginal burning).\nOverall, the quality of the evidence is poor. Most studies were judged to have unclear or high risk of bias across most domains. Data was sparse and addressed very few outcomes. The GRADE evaluation was rated as very low certainty evidence due to very serious limitations in the study design or execution (high risk of bias across all studies) and sparse data (single study data and small sample sizes).\nAuthors' conclusions\nThere is currently little to no evidence to support or refute the use of D-mannose to prevent or treat UTIs in all populations.\nThis review highlights the severe lack of high-quality RCTs testing the efficacy of D-mannose for UTIs in any population. Despite UTIs being one of the most common adult infections (affecting 50% of women at least once in their lifetime) and the growing global antimicrobial resistance, we found very few studies that adequately test this alternative treatment.\nFuture research in this field requires, in the first instance, a single adequately powered RCT comparing D-mannose with placebo.\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": "Urinary tract infections (UTIs) are very common around the world. At least 50% of females will have a UTI once in their lifetime. Approximately 15% to 25% of adults and children suffer from repeated and long-term UTIs. In many people, standard antibiotics do not work.\nD-mannose is a sugar which is part of a normal diet and is believed to create a non-stick surface on the bladder wall, as well as around the bacteria. It is thought that the bacteria is then expelled when urinating, thus preventing the growth of bacteria which leads to an infection inside the bladder or urinary tract."
}
]
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query-laysum | 2445 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is a genetic haemoglobin disorder, which can cause severe pain, significant end-organ damage, pulmonary complications, and premature death. Sickle cell disease is one of the most common severe monogenic disorders in the world, due to the inheritance of two abnormal haemoglobin (beta globin) genes. The two most common chronic chest complications due to sickle cell disease are pulmonary hypertension and chronic sickle lung disease. These complications can lead to morbidity (such as reduced exercise tolerance) and increased mortality.\nThis is an update of a Cochrane Review first published in 2011 and updated in 2014 and 2016.\nObjectives\nWe wanted to determine whether trials involving people with sickle cell disease that compare regular long-term blood transfusion regimens with standard care, hydroxycarbamide (hydroxyurea) any other drug treatment show differences in the following: mortality associated with chronic chest complications; severity of established chronic chest complications; development and progression of chronic chest complications; serious adverse events.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register. Date of the last search: 19 September 2019.\nWe also searched for randomised controlled trials in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 10, 14 November 2018), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 14 November 2018.\nSelection criteria\nWe included randomised controlled trials of people of any age with one of four common sickle cell disease genotypes, i.e. Hb SS, Sβº, SC, or Sβ+ that compared regular red blood cell transfusion regimens (either simple or exchange transfusions) to hydroxycarbamide, any other drug treatment, or to standard care that were aimed at reducing the development or progression of chronic chest complications (chronic sickle lung and pulmonary hypertension).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nNo studies matching the selection criteria were found.\nAuthors' conclusions\nThere is a need for randomised controlled trials looking at the role of long-term transfusion therapy in pulmonary hypertension and chronic sickle lung disease. Due to the chronic nature of the conditions, such trials should aim to use a combination of objective and subjective measures to assess participants repeatedly before and after the intervention.\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 are no results because we found no relevant randomised controlled trials. We would need to design a study with at least 946 participants to be able to detect a decrease in the number of people who died from 12 in 100 to six in 100."
}
]
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query-laysum | 2446 | [
{
"role": "user",
"content": "Abstract: Background\nHyperopia in infancy requires accommodative effort to bring images into focus. Prolonged accommodative effort has been associated with an increased risk of strabismus. Strabismus may result in asthenopia and intermittent diplopia, and makes near work tasks difficult to complete. Spectacles to correct hyperopic refractive error is believed to prevent the development of strabismus.\nObjectives\nTo assess the effectiveness of prescription spectacles compared with no intervention for the prevention of strabismus in infants and children with hyperopia.\nSearch methods\nWe searched CENTRAL (2018, Issue 12; which contains the Cochrane Eyes and Vision Trials Register); Ovid MEDLINE; Embase.com; three other databases; and two trial registries. We used no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 4 December 2018.\nSelection criteria\nWe included randomized controlled trials and quasi-randomized trials investigating spectacle intervention or no treatment for children with hyperopia. We required hyperopia to be at least greater than +2.00 diopters (D).\nData collection and analysis\nWe used standard Cochrane methodological procedures. The primary outcome was the proportion of children with manifest strabismus, as defined by study investigators. Other outcomes included the amblyopia, stereoacuity, and the effect of spectacle use of strabismus and visual acuity. We also collected information on change in refractive error as a measurement of the interference of emmetropization.\nMain results\nWe identified four randomized controlled trials (985 children enrolled who were aged six months to less than 36 months) in this review. Three trials were in the UK with follow-up periods ranging from one to 3.5 years and one in the US with three years' follow-up.\nInvestigators reported both incidence and final status regarding strabismus. Evidence of the incidence of strabismus, measured in 804 children over three to four years in four trials was uncertain although suggestive of a benefit with spectacle use (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.41 to 1.02). We have very low confidence in these results due to high risk of bias, inconsistency, and imprecision. When assessed as the proportion of children with strabismus at the end of three years' follow-up, we found a similar level of evidence for an effect of spectacles on strabismus as reported in one study (RR 1.00, 95% CI 0.31 to 3.25; 106 children). We have very low confidence in these results because of low sample size and risk of bias.\nOne trial reported on the risk for developing amblyopia and inadequate stereoacuity after three years in 106 children. There was unclear evidence for a decreased risk of developing amblyopia (RR 0.78, 95% CI 0.31 to 1.93), and limited evidence for a benefit of spectacles for prevention of inadequate stereoacuity (RR 0.38, 95% CI 0.16 to 0.88). We have very low confidence in these findings due to imprecision and risk of bias.\nThe risk of not developing emmetropization is unclear. One trial reported on the proportion of children not achieving emmetropization at three years' follow-up (RR 0.75, 95% CI 0.18 to 3.19). One trial suggested spectacles impede emmetropization, and one trial reported no difference. These two trials could not be combined because the methods for assessing emmetropization were different. With the high risk of bias and inconsistency, the certainty of evidence for a risk for impeding or benefiting emmetropization is very low.\nBased on a meta-analysis of four trials (770 children), the risk of having visual acuity worse than 20/30 measured up to three years of age or at the end of three years of follow-up was uncertain for children with spectacle correction compared with those without correction (RR 0.87, 95% CI 0.64 to 1.18; very low confidence due to risk of bias and imprecision).\nAuthors' conclusions\nThe effect of spectacle correction for prevention of strabismus is still unclear. In addition, the use of spectacle on the risk of visual acuity worse than 20/30, amblyopia, and inadequate emmetropization is also unclear. There may be a benefit on prevention of inadequate stereoacuity. However, these effects may have been chance findings or due to bias.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence does not currently support the conclusion that eyeglasses prevent strabismus in far-sighted children, or that wearing glasses prevents lazy-eye (amblyopia). This evidence was limited due to some parts of the studies not being done as well as they could and small number of study participants."
}
]
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query-laysum | 2447 | [
{
"role": "user",
"content": "Abstract: Background\nThe mean age of women undergoing local treatment for pre-invasive cervical disease (cervical intra-epithelial neoplasia; CIN) or early cervical cancer (stage IA1) is around their 30s and similar to the age of women having their first child. Local cervical treatment has been correlated to adverse reproductive morbidity in a subsequent pregnancy, however, published studies and meta-analyses have reached contradictory conclusions.\nObjectives\nTo assess the effect of local cervical treatment for CIN and early cervical cancer on obstetric outcomes (after 24 weeks of gestation) and to correlate these to the cone depth and comparison group used.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, 2017, Issue 5), MEDLINE (up to June week 4, 2017) and Embase (up to week 26, 2017). In an attempt to identify articles missed by the search or unpublished data, we contacted experts in the field and we handsearched the references of the retrieved articles and conference proceedings.\nSelection criteria\nWe included all studies reporting on obstetric outcomes (more than 24 weeks of gestation) in women with or without a previous local cervical treatment for any grade of CIN or early cervical cancer (stage IA1). Treatment included both excisional and ablative methods. We excluded studies that had no untreated reference population, reported outcomes in women who had undergone treatment during pregnancy or had a high-risk treated or comparison group, or both\nData collection and analysis\nWe classified studies according to the type of treatment and the obstetric endpoint. Studies were classified according to method and obstetric endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CIs) were calculated using a random-effects model and inverse variance. Inter-study heterogeneity was assessed with I2 statistics. We assessed maternal outcomes that included preterm birth (PTB) (spontaneous and threatened), preterm premature rupture of the membranes (pPROM), chorioamnionitis, mode of delivery, length of labour, induction of delivery, oxytocin use, haemorrhage, analgesia, cervical cerclage and cervical stenosis. The neonatal outcomes included low birth weight (LBW), neonatal intensive care unit (NICU) admission, stillbirth, perinatal mortality and Apgar scores.\nMain results\nWe included 69 studies (6,357,823 pregnancies: 65,098 pregnancies of treated and 6,292,725 pregnancies of untreated women). Many of the studies included only small numbers of women, were of heterogenous design and in their majority retrospective and therefore at high risk of bias. Many outcomes were assessed to be of low or very low quality (GRADE assessment) and therefore results should be interpreted with caution. Women who had treatment were at increased overall risk of preterm birth (PTB) (less than 37 weeks) (10.7% versus 5.4%, RR 1.75, 95% CI 1.57 to 1.96, 59 studies, 5,242,917 participants, very low quality), severe (less than 32 to 34 weeks) (3.5% versus 1.4%, RR 2.25, 95% CI 1.79 to 2.82), 24 studies, 3,793,874 participants, very low quality), and extreme prematurity (less than 28 to 30 weeks) (1.0% versus 0.3%, (RR 2.23, 95% CI 1.55 to 3.22, 8 studies, 3,910,629 participants, very low quality), as compared to women who had no treatment.\nThe risk of overall prematurity was higher for excisional (excision versus no treatment: 11.2% versus 5.5%, RR 1.87, 95% CI 1.64 to 2.12, 53 studies, 4,599,416 participants) than ablative (ablation versus no treatment: 7.7% versus 4.6%, RR 1.35, 95% CI 1.20 to 1.52, 14 studies, 602,370 participants) treatments and the effect was higher for more radical excisional techniques (less than 37 weeks: cold knife conisation (CKC) (RR 2.70, 95% CI 2.14 to 3.40, 12 studies, 39,102 participants), laser conisation (LC) (RR 2.11, 95% CI 1.26 to 3.54, 9 studies, 1509 participants), large loop excision of the transformation zone (LLETZ) (RR 1.58, 95% CI 1.37 to 1.81, 25 studies, 1,445,104 participants). Repeat treatment multiplied the risk of overall prematurity (repeat versus no treatment: 13.2% versus 4.1%, RR 3.78, 95% CI 2.65 to 5.39, 11 studies, 1,317,284 participants, very low quality). The risk of overall prematurity increased with increasing cone depth (less than 10 mm to 12 mm versus no treatment: 7.1% versus 3.4%, RR 1.54, 95% CI 1.09 to 2.18, 8 studies, 550,929 participants, very low quality; more than 10 mm to 12 mm versus no treatment: 9.8% versus 3.4%, RR 1.93, 95% CI 1.62 to 2.31, 8 studies, 552,711 participants, low quality; more than 15 mm to 17 mm versus no treatment: 10.1 versus 3.4%, RR 2.77, 95% CI 1.95 to 3.93, 4 studies, 544,986 participants, very low quality; 20 mm or more versus no treatment: 10.2% versus 3.4%, RR 4.91, 95% CI 2.06 to 11.68, 3 studies, 543,750 participants, very low quality). The comparison group affected the magnitude of effect that was higher for external, followed by internal comparators and ultimately women with disease, but no treatment. Untreated women with disease and the pre-treatment pregnancies of the women who were treated subsequently had higher risk of overall prematurity than the general population (5.9% versus 5.6%, RR 1.24, 95% CI 1.14 to 1.34, 15 studies, 4,357,998 participants, very low quality).\npPROM (6.1% versus 3.4%, RR 2.36, 95% CI 1.76 to 3.17, 21 studies, 477,011 participants, very low quality), low birth weight (7.9% versus 3.7%, RR 1.81, 95% CI 1.58 to 2.07, 30 studies, 1,348,206 participants, very low quality), NICU admission rate (12.6% versus 8.9%, RR 1.45, 95% CI 1.16 to 1.81, 8 studies, 2557 participants, low quality) and perinatal mortality (0.9% versus 0.7%, RR 1.51, 95% CI 1.13 to 2.03, 23 studies, 1,659,433 participants, low quality) were also increased after treatment.\nAuthors' conclusions\nWomen with CIN have a higher baseline risk for prematurity. Excisional and ablative treatment appears to further increases that risk. The frequency and severity of adverse sequelae increases with increasing cone depth and is higher for excision than it is for ablation. However, the results should be interpreted with caution as they were based on low or very low quality (GRADE assessment) observational studies, most of which were retrospective.\n\nGiven the provided abstract, please respond to the following query: \"What is the quality of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to the nature of the intervention and outcomes studied, we were only able to include observational studies, of which the majority were retrospective. These types of studies are of low quality with a high level of variability between the studies, therefore the level of evidence for most outcomes can only be considered to be of low or very low quality."
}
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query-laysum | 2448 | [
{
"role": "user",
"content": "Abstract: Background\nPaediatric flat feet are a common presentation in primary care; reported prevalence approximates 15%. A minority of flat feet can hurt and limit gait. There is no optimal strategy, nor consensus, for using foot orthoses (FOs) to treat paediatric flat feet.\nObjectives\nTo assess the benefits and harms of foot orthoses for treating paediatric flat feet.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase to 01 September 2021, and two clinical trials registers on 07 August 2020.\nSelection criteria\nWe identified all randomised controlled trials (RCTs) of FOs as an intervention for paediatric flat feet. The outcomes included in this review were pain, function, quality of life, treatment success, and adverse events. Intended comparisons were: any FOs versus sham, any FOs versus shoes, customised FOs (CFOs) versus prefabricated FOs (PFOs).\nData collection and analysis\nWe followed standard methods recommended by Cochrane.\nMain results\nWe included 16 trials with 1058 children, aged 11 months to 19 years, with flexible flat feet. Distinct flat foot presentations included asymptomatic, juvenile idiopathic arthritis (JIA), symptomatic and developmental co-ordination disorder (DCD). The trial interventions were FOs, footwear, foot and rehabilitative exercises, and neuromuscular electrical stimulation (NMES). Due to heterogeneity, we did not pool the data. Most trials had potential for selection, performance, detection, and selective reporting bias. No trial blinded participants. We present the results separately for asymptomatic (healthy children) and symptomatic (children with JIA) flat feet.\nThe certainty of evidence was very low to low, downgraded for bias, imprecision, and indirectness.\nThree comparisons were evaluated across trials: CFO versus shoes; PFO versus shoes; CFO versus PFO.\nAsymptomatic flat feet\n1. CFOs versus shoes (1 trial, 106 participants): low-quality evidence showed that CFOs result in little or no difference in the proportion without pain (10-point visual analogue scale (VAS)) at one year (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.67 to 1.07); absolute decrease (11.8%, 95% CI 4.7% fewer to 15.8% more); or on withdrawals due to adverse events (RR 1.05, 95% CI 0.94 to 1.19); absolute effect (3.4% more, 95% CI 4.1% fewer to 13.1% more).\n2. PFOs versus shoes (1 trial, 106 participants): low to very-low quality evidence showed that PFOs result in little or no difference in the proportion without pain (10-point VAS) at one year (RR 0.94, 95% CI 0.76 to 1.16); absolute effect (4.7% fewer, 95% CI 18.9% fewer to 12.6% more); or on withdrawals due to adverse events (RR 0.99, 95% CI 0.79 to 1.23).\n3. CFOs versus PFOs (1 trial, 108 participants): low-quality evidence found no difference in the proportion without pain at one year (RR 0.93, 95% CI 0.73 to 1.18); absolute effect (7.4% fewer, 95% CI 22.2% fewer to 11.1% more); or on withdrawal due to adverse events (RR 1.00, 95% CI 0.90 to 1.12).\nFunction and quality of life (QoL) were not assessed.\nSymptomatic (JIA) flat feet\n1. CFOs versus shoes (1 trial, 28 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain (0 to 10 scale, 0 no pain) between groups (MD -1.5, 95% CI -2.78 to -0.22). Low-quality evidence showed improvements in function with CFOs (Foot Function Index - FFI disability, 0 to 100, 0 best function; MD -18.55, 95% CI -34.42 to -2.68), child-rated QoL (PedsQL, 0 to 100, 100 best quality; MD 12.1, 95% CI -1.6 to 25.8) and parent-rated QoL (PedsQL MD 9, 95% CI -4.1 to 22.1) and little or no difference between groups in treatment success (timed walking; MD -1.33 seconds, 95% CI -2.77 to 0.11), or withdrawals due to adverse events (RR 0.58, 95% CI 0.11 to 2.94); absolute difference (9.7% fewer, 20.5 % fewer to 44.8% more).\n2. PFOs versus shoes (1 trial, 25 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain between groups (MD 0.02, 95% CI -1.94 to 1.98). Low-quality evidence showed no difference between groups in function (FFI-disability MD -4.17, 95% CI -24.4 to 16.06), child-rated QoL (PedsQL MD -3.84, 95% CI -19 to 11.33), or parent-rated QoL (PedsQL MD -0.64, 95% CI -13.22 to 11.94).\n3. CFOs versus PFOs (2 trials, 87 participants): low-quality evidence showed little or no difference between groups in pain (0 to 10 scale, 0 no pain) at 3 months (MD -1.48, 95% CI -3.23 to 0.26), function (FFI-disability MD -7.28, 95% CI -15.47 to 0.92), child-rated QoL (PedsQL MD 8.6, 95% CI -3.9 to 21.2), or parent-rated QoL (PedsQL MD 2.9, 95% CI -11 to 16.8).\nAuthors' conclusions\nLow to very low-certainty evidence shows that the effect of CFOs (high cost) or PFOs (low cost) versus shoes, and CFOs versus PFOs on pain, function and HRQoL is uncertain. This is pertinent for clinical practice, given the economic disparity between CFOs and PFOs. FOs may improve pain and function, versus shoes in children with JIA, with minimal delineation between costly CFOs and generic PFOs.\nThis review updates that from 2010, confirming that in the absence of pain, the use of high-cost CFOs for healthy children with flexible flat feet has no supporting evidence, and draws very limited conclusions about FOs for treating paediatric flat feet.\nThe availability of normative and prospective foot development data, dismisses most flat foot concerns, and negates continued attention to this topic. Attention should be re-directed to relevant paediatric foot conditions, which cause pain, limit function, or reduce quality of life. The agenda for researching asymptomatic flat feet in healthy children must be relegated to history, and replaced by a targeted research rationale, addressing children with indisputable foot pathology from discrete diagnoses, namely JIA, cerebral palsy, congenital talipes equino varus, trisomy 21 and Charcot Marie Tooth. Whether research resources should continue to be wasted on studying flat feet in healthy children that do not hurt, is questionable. Future updates of this review will address only relevant paediatric foot conditions.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
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query-laysum | 2449 | [
{
"role": "user",
"content": "Abstract: Background\nCalcium channel blockers are a heterogeneous class of drugs, including dihydropyridine and non-dihydropyridine subgroups, commonly used in the treatment of hypertension. A systematic review of the 24-hour time course of the blood pressure-lowering effect has not been published.\nObjectives\nTo assess how much variation there is in hourly systolic and diastolic blood pressure lowering by dihydropyridine calcium channel blockers over a 24-hour period in people with hypertension aged 18 years or over, with baseline systolic blood pressure of at least 140 mmHg or diastolic blood pressure of at least 90 mmHg, or both.\nSearch methods\nWe performed electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2014), MEDLINE (1946 to February 2014), EMBASE (1974 to February 2014), and ClinicalTrials.gov (to February 2014). We also screened references of published studies and reviews to identify additional trials.\nSelection criteria\nWe included all randomized, placebo-controlled trials assessing the hourly effects of dihydropyridine calcium channel blockers by ambulatory blood pressure monitoring in adults with hypertension with a follow-up of at least three weeks.\nData collection and analysis\nTwo authors independently selected the included trials, evaluated the risk of bias, and analyzed the data.\nMain results\nWe included 16 randomized controlled trials of dihydropyridine calcium channel blockers in this systematic review, with 2768 randomized participants. Drugs studied included amlodipine, lercanidipine, mandipine, nifedipine, and felodipine (all administered once daily) and nicardipine (administered twice daily). We analyzed and presented data by hour post dose. The blood pressure-lowering effect was stable over time; there were no clinically important differences in blood pressure-lowering effect of calcium channel blockers between each hour for either systolic blood pressure (estimated mean hourly differences ranged between 9.45 mmHg and 13.2 mmHg) or diastolic blood pressure (estimated mean hourly differences ranged between 5.85 mmHg and 8.5 mmHg). However, there was a moderate risk of bias for this finding. Once-daily dihydropyridine calcium channel blockers appeared to lower blood pressure by a relatively constant amount throughout the 24-hour dosing interval.\nAuthors' conclusions\nSix dihydropyridine calcium channel blockers studied in this review lowered blood pressure by a relatively similar amount each hour over the course of 24 hours. The benefits and harms of this pattern of blood pressure lowering are unknown. Further trials are needed with accurate recording of time of drug intake and with reporting of standard deviation of blood pressure at each hour. We did not attempt to assess adverse effects in this review due to the lack of reporting and the short duration of follow-up.\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 judged the overall quality of the evidence to be moderate. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate."
}
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query-laysum | 2450 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization recommends intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for malaria for all women who live in moderate to high malaria transmission areas in Africa. However, parasite resistance to sulfadoxine-pyrimethamine has been increasing steadily in some areas of the region. Moreover, HIV-infected women on cotrimoxazole prophylaxis cannot receive sulfadoxine-pyrimethamine because of potential drug interactions. Thus, there is an urgent need to identify alternative drugs for prevention of malaria in pregnancy. One such candidate is mefloquine.\nObjectives\nTo assess the effects of mefloquine for preventing malaria in pregnant women, specifically, to evaluate:\n• the efficacy, safety, and tolerability of mefloquine for preventing malaria in pregnant women; and\n• the impact of HIV status, gravidity, and use of insecticide-treated nets on the effects of mefloquine.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, Latin American Caribbean Health Sciences Literature (LILACS), the Malaria in Pregnancy Library, and two trial registers up to 31 January 2018. In addition, we checked references and contacted study authors to identify additional studies, unpublished data, confidential reports, and raw data from published trials.\nSelection criteria\nRandomized and quasi-randomized controlled trials comparing mefloquine IPT or mefloquine prophylaxis against placebo, no treatment, or an alternative drug regimen.\nData collection and analysis\nTwo review authors independently screened all records identified by the search strategy, applied inclusion criteria, assessed risk of bias, and extracted data. We contacted trial authors to ask for additional information when required. Dichotomous outcomes were compared using risk ratios (RRs), count outcomes as incidence rate ratios (IRRs), and continuous outcomes using mean differences (MDs). We have presented all measures of effect with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach for the following main outcomes of analysis: maternal peripheral parasitaemia at delivery, clinical malaria episodes during pregnancy, placental malaria, maternal anaemia at delivery, low birth weight, spontaneous abortions and stillbirths, dizziness, and vomiting.\nMain results\nSix trials conducted between 1987 and 2013 from Thailand (1), Benin (3), Gabon (1), Tanzania (1), Mozambique (2), and Kenya (1) that included 8192 pregnant women met our inclusion criteria.\nTwo trials (with 6350 HIV-uninfected pregnant women) compared two IPTp doses of mefloquine with two IPTp doses of sulfadoxine-pyrimethamine. Two other trials involving 1363 HIV-infected women compared three IPTp doses of mefloquine plus cotrimoxazole with cotrimoxazole. One trial in 140 HIV-infected women compared three doses of IPTp-mefloquine with cotrimoxazole. Finally, one trial enrolling 339 of unknown HIV status compared mefloquine prophylaxis with placebo.\nStudy participants included women of all gravidities and of all ages (four trials) or > 18 years (two trials). Gestational age at recruitment was > 20 weeks (one trial), between 16 and 28 weeks (three trials), or ≤ 28 weeks (two trials). Two of the six trials blinded participants and personnel, and only one had low risk of detection bias for safety outcomes.\nWhen compared with sulfadoxine-pyrimethamine, IPTp-mefloquine results in a 35% reduction in maternal peripheral parasitaemia at delivery (RR 0.65, 95% CI 0.48 to 0.86; 5455 participants, 2 studies; high-certainty evidence) but may have little or no effect on placental malaria infections (RR 1.04, 95% CI 0.58 to 1.86; 4668 participants, 2 studies; low-certainty evidence). Mefloquine results in little or no difference in the incidence of clinical malaria episodes during pregnancy (incidence rate ratio (IRR) 0.83, 95% CI 0.65 to 1.05, 2 studies; high-certainty evidence). Mefloquine decreased maternal anaemia at delivery (RR 0.84, 95% CI 0.76 to 0.94; 5469 participants, 2 studies; moderate-certainty evidence). Data show little or no difference in the proportions of low birth weight infants (RR 0.95, 95% CI 0.78 to 1.17; 5641 participants, 2 studies; high-certainty evidence) and in stillbirth and spontaneous abortion rates (RR 1.20, 95% CI 0.91 to 1.58; 6219 participants, 2 studies; I2 statistic = 0%; moderate-certainty evidence). IPTp-mefloquine increased drug-related vomiting (RR 4.76, 95% CI 4.13 to 5.49; 6272 participants, 2 studies; high-certainty evidence) and dizziness (RR 4.21, 95% CI 3.36 to 5.27; participants = 6272, 2 studies; moderate-certainty evidence).\nWhen compared with cotrimoxazole, IPTp-mefloquine plus cotrimoxazole probably results in a 48% reduction in maternal peripheral parasitaemia at delivery (RR 0.52, 95% CI 0.30 to 0.93; 989 participants, 2 studies; moderate-certainty evidence) and a 72% reduction in placental malaria (RR 0.28, 95% CI 0.14 to 0.57; 977 participants, 2 studies; moderate-certainty evidence) but has little or no effect on the incidence of clinical malaria episodes during pregnancy (IRR 0.76, 95% CI 0.33 to 1.76, 1 study; high-certainty evidence) and probably no effect on maternal anaemia at delivery (RR 0.94, 95% CI 0.73 to 1.20; 1197 participants, 2 studies; moderate-certainty evidence), low birth weight rates (RR 1.20, 95% CI 0.89 to 1.60; 1220 participants, 2 studies; moderate-certainty evidence), and rates of spontaneous abortion and stillbirth (RR 1.12, 95% CI 0.42 to 2.98; 1347 participants, 2 studies; very low-certainty evidence). Mefloquine was associated with higher risks of drug-related vomiting (RR 7.95, 95% CI 4.79 to 13.18; 1055 participants, one study; high-certainty evidence) and dizziness (RR 3.94, 95% CI 2.85 to 5.46; 1055 participants, 1 study; high-certainty evidence).\nAuthors' conclusions\nMefloquine was more efficacious than sulfadoxine-pyrimethamine in HIV-uninfected women or daily cotrimoxazole prophylaxis in HIV-infected pregnant women for prevention of malaria infection and was associated with lower risk of maternal anaemia, no adverse effects on pregnancy outcomes (such as stillbirths and abortions), and no effects on low birth weight and prematurity. However, the high proportion of mefloquine-related adverse events constitutes an important barrier to its effectiveness for malaria preventive treatment in pregnant women.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found five relevant studies conducted in sub-Saharan Africa and one in Thailand between 1987 and 2013. These studies compared mefloquine with placebo or other antimalarial drugs currently recommended for prevention of malaria in pregnant women. The review shows the following:\n• Compared with sulfadoxine-pyrimethamine, mefloquine chemoprevention in HIV-uninfected women:\n◦reduces risks of maternal peripheral parasitaemia (presence of malaria parasites in the blood of women) and anaemia at delivery;\n◦ makes no difference in the prevalence of adverse maternal outcomes (such as low birth weight, prematurity, stillbirths and abortions, and congenital malformations) and in the incidence of clinical malaria episodes during pregnancy; and\n◦ increases risks of drug-related adverse events including vomiting, fatigue/weakness, and dizziness.\n• Compared with cotrimoxale prophylaxis alone, mefloquine chemoprevention plus cotrimoxazole in HIV-infected women:\n◦ reduces the risk of maternal peripheral parasitaemia at delivery and the risk of placental malaria;\n◦ makes no difference in the prevalence of adverse pregnancy outcomes (such as low birth weight, prematurity, stillbirths and abortions, and congenital malformations) and in the incidence of clinical malaria episodes during pregnancy; and\n◦ increases the risk of drug-related adverse events such as vomiting and dizziness.\nOverall, the high proportion of mefloquine-related adverse events constitutes an important barrier to its effectiveness for malaria preventive treatment in pregnant women."
}
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query-laysum | 2451 | [
{
"role": "user",
"content": "Abstract: Background\nDietary changes are routinely recommended in people with chronic kidney disease (CKD) on the basis of randomised evidence in the general population and non-randomised studies in CKD that suggest certain healthy eating patterns may prevent cardiovascular events and lower mortality. People who have kidney disease have prioritised dietary modifications as an important treatment uncertainty.\nObjectives\nThis review evaluated the benefits and harms of dietary interventions among adults 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 Specialised Register (up to 31 January 2017) through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-randomised RCTs of dietary interventions versus other dietary interventions, lifestyle advice, or standard care assessing mortality, cardiovascular events, health-related quality of life, and biochemical, anthropomorphic, and nutritional outcomes among people with CKD.\nData collection and analysis\nTwo authors independently screened studies for inclusion and extracted data. Results were summarised as risk ratios (RR) for dichotomous outcomes or mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI) or in descriptive format when meta-analysis was not possible. Confidence in the evidence was assessed using GRADE.\nMain results\nWe included 17 studies involving 1639 people with CKD. Three studies enrolled 341 people treated with dialysis, four studies enrolled 168 kidney transplant recipients, and 10 studies enrolled 1130 people with CKD stages 1 to 5. Eleven studies (900 people) evaluated dietary counselling with or without lifestyle advice and six evaluated dietary patterns (739 people), including one study (191 people) of a carbohydrate-restricted low-iron, polyphenol enriched diet, two studies (181 people) of increased fruit and vegetable intake, two studies (355 people) of a Mediterranean diet and one study (12 people) of a high protein/low carbohydrate diet. Risks of bias in the included studies were generally high or unclear, lowering confidence in the results. Participants were followed up for a median of 12 months (range 1 to 46.8 months).\nStudies were not designed to examine all-cause mortality or cardiovascular events. In very-low quality evidence, dietary interventions had uncertain effects on all-cause mortality or ESKD. In absolute terms, dietary interventions may prevent one person in every 3000 treated for one year avoiding ESKD, although the certainty in this effect was very low. Across all 17 studies, outcome data for cardiovascular events were sparse. Dietary interventions in low quality evidence were associated with a higher health-related quality of life (2 studies, 119 people: MD in SF-36 score 11.46, 95% CI 7.73 to 15.18; I2 = 0%). Adverse events were generally not reported.\nDietary interventions lowered systolic blood pressure (3 studies, 167 people: MD -9.26 mm Hg, 95% CI -13.48 to -5.04; I2 = 80%) and diastolic blood pressure (2 studies, 95 people: MD -8.95, 95% CI -10.69 to -7.21; I2 = 0%) compared to a control diet. Dietary interventions were associated with a higher estimated glomerular filtration rate (eGFR) (5 studies, 219 people: SMD 1.08; 95% CI 0.26 to 1.97; I2 = 88%) and serum albumin levels (6 studies, 541 people: MD 0.16 g/dL, 95% CI 0.07 to 0.24; I2 = 26%). A Mediterranean diet lowered serum LDL cholesterol levels (1 study, 40 people: MD -1.00 mmol/L, 95% CI -1.56 to -0.44).\nAuthors' conclusions\nDietary interventions have uncertain effects on mortality, cardiovascular events and ESKD among people with CKD as these outcomes were rarely measured or reported. Dietary interventions may increase health-related quality of life, eGFR, and serum albumin, and lower blood pressure and serum cholesterol levels.\nBased on stakeholder prioritisation of dietary research in the setting of CKD and preliminary evidence of beneficial effects on risks factors for clinical outcomes, large-scale pragmatic RCTs to test the effects of dietary interventions on patient outcomes are required.\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 combined all studies looking at dietary changes for people who kidney disease including people treated with dialysis or who have a kidney transplant."
}
]
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query-laysum | 2452 | [
{
"role": "user",
"content": "Abstract: Background\nAppendiceal phlegmon and abscess account for 2% to 10% of acute appendicitis. People with appendiceal phlegmon or abscess usually need an appendicectomy to relieve their symptoms and avoid complications. The timing of appendicectomy for appendiceal phlegmon or abscess is controversial.\nObjectives\nTo assess the effects of early versus delayed appendicectomy for appendiceal phlegmon or abscess, in terms of overall morbidity and mortality.\nSearch methods\nWe searched the Cochrane Library (CENTRAL; 2016, Issue 7), MEDLINE Ovid (1950 to 23 August 2016), Embase Ovid (1974 to 23 August 2016), Science Citation Index Expanded (1900 to 23 August 2016), and the Chinese Biomedical Literature Database (CBM) (1978 to 23 August 2016). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform search portal (23 August 2016) and ClinicalTrials.gov (23 August 2016) for ongoing trials.\nSelection criteria\nWe included all individual and cluster-randomised controlled trials, irrespective of language, publication status, or age of participants, comparing early versus delayed appendicectomy in people with appendiceal phlegmon or abscess.\nData collection and analysis\nTwo review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI).\nMain results\nWe included two randomised controlled trials with a total of 80 participants in this review.\n1. Early versus delayed open appendicectomy for appendiceal phlegmon\nForty participants (paediatric and adults) with appendiceal phlegmon were randomised either to early appendicectomy (appendicectomy as soon as appendiceal mass resolved within the same admission) (n = 20), or to delayed appendicectomy (initial conservative treatment followed by interval appendicectomy six weeks later) (n = 20). The trial was at high risk of bias. There was no mortality in either group. There is insufficient evidence to determine the effect of using either early or delayed open appendicectomy onoverall morbidity (RR 13.00; 95% CI 0.78 to 216.39; very low-quality evidence), the proportion of participants who developed wound infection (RR 9.00; 95% CI 0.52 to 156.91; very low quality evidence) or faecal fistula (RR 3.00; 95% CI 0.13 to 69.52; very low quality evidence). The quality of evidence for increased length of hospital stay and time away from normal activities in the early appendicectomy group (MD 6.70 days; 95% CI 2.76 to 10.64, and MD 5.00 days; 95% CI 1.52 to 8.48, respectively) is very low quality evidence. The trial reported neither quality of life nor pain outcomes.\n2. Early versus delayed laparoscopic appendicectomy for appendiceal abscess\nForty paediatric participants with appendiceal abscess were randomised either to early appendicectomy (emergent laparoscopic appendicectomy) (n = 20) or to delayed appendicectomy (initial conservative treatment followed by interval laparoscopic appendicectomy 10 weeks later) (n = 20). The trial was at high risk of bias. The trial did not report on overall morbidity or complications. There was no mortality in either group. We do not have sufficient evidence to determine the effects of using either early or delayed laparoscopic appendicectomy for outcomes relating to hospital stay between the groups (MD −0.20 days; 95% CI −3.54 to 3.14; very low quality of evidence). Health-related quality of life was measured with the Pediatric Quality of Life Scale-Version 4.0 questionnaire (a scale of 0 to 100 with higher values indicating a better quality of life). Health-related quality of life score measured at 12 weeks after appendicectomy was higher in the early appendicectomy group than in the delayed appendicectomy group (MD 12.40 points; 95% CI 9.78 to 15.02) but the quality of evidence was very low. This trial reported neither the pain nor the time away from normal activities.\nAuthors' conclusions\nIt is unclear whether early appendicectomy prevents complications compared to delayed appendicectomy for people with appendiceal phlegmon or abscess. The evidence indicating increased length of hospital stay and time away from normal activities in people with early open appendicectomy is of very low quality. The evidence for better health-related quality of life following early laparoscopic appendicectomy compared with delayed appendicectomy is based on very low quality evidence. For both comparisons addressed in this review, data are sparse, and we cannot rule out significant benefits or harms of early versus delayed appendicectomy.\nFurther trials on this topic are urgently needed and should specify a set of criteria for use of antibiotics, percutaneous drainage of the appendiceal abscess prior to surgery and resolution of the appendiceal phlegmon or abscess. Future trials should include outcomes such as time away from normal activities, quality of life and the length of hospital stay.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Both trials were at a high risk of bias. Overall, we judged the quality of the evidence to be very low. Thus, further well-designed trials are urgently needed."
}
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query-laysum | 2453 | [
{
"role": "user",
"content": "Abstract: Background\nAn occlusion or stenosis of intracranial large arteries can be detected in the acute phase of ischaemic stroke in about 42% of patients. The approved therapies for acute ischaemic stroke are thrombolysis with intravenous recombinant tissue plasminogen activator (rt-PA), and mechanical thrombectomy; both aim to recanalise an occluded intracranial artery. The reference standard for the diagnosis of intracranial stenosis and occlusion is intra-arterial angiography (IA) and, recently, computed tomography angiography (CTA) and magnetic resonance angiography (MRA), or contrast-enhanced MRA. Transcranial Doppler (TCD) and transcranial colour Doppler (TCCD) are useful, rapid, noninvasive tools for the assessment of intracranial large arteries pathology. Due to the current lack of consensus regarding the use of TCD and TCCD in clinical practice, we systematically reviewed the literature for studies assessing the diagnostic accuracy of these techniques compared with intra-arterial IA, CTA, and MRA for the detection of intracranial stenosis and occlusion in people presenting with symptoms of ischaemic stroke.\nObjectives\nTo assess the diagnostic accuracy of TCD and TCCD for detecting stenosis and occlusion of intracranial large arteries in people with acute ischaemic stroke.\nSearch methods\nWe limited our searches from January 1982 onwards as the transcranial Doppler technique was only introduced into clinical practice in the 1980s. We searched MEDLINE (Ovid) (from 1982 to 2018); Embase (Ovid) (from 1982 to 2018); Database of Abstracts of Reviews of Effects (DARE); and Health Technology Assessment Database (HTA) (from 1982 to 2018). Moreover, we perused the reference lists of all retrieved articles and of previously published relevant review articles, handsearched relevant conference proceedings, searched relevant websites, and contacted experts in the field.\nSelection criteria\nWe included all studies comparing TCD or TCCD (index tests) with IA, CTA, MRA, or contrast-enhanced MRA (reference standards) in people with acute ischaemic stroke, where all participants underwent both the index test and the reference standard within 24 hours of symptom onset. We included prospective cohort studies and randomised studies of test comparisons. We also considered retrospective studies eligible for inclusion where the original population sample was recruited prospectively but the results were analysed retrospectively.\nData collection and analysis\nAt least two review authors independently screened the titles and abstracts identified by the search strategies, applied the inclusion criteria, extracted data, assessed methodological quality (using QUADAS-2), and investigated heterogeneity. We contacted study authors for missing data.\nMain results\nA comprehensive search of major relevant electronic databases (MEDLINE and Embase) from 1982 to 13 March 2018 yielded 13,534 articles, of which nine were deemed eligible for inclusion. The studies included a total of 493 participants. The mean age of included participants was 64.2 years (range 55.8 to 69.9 years). The proportion of men and women was similar across studies. Six studies recruited participants in Europe, one in south America, one in China, and one in Egypt. Risk of bias was high for participant selection but low for flow, timing, index and reference standard. The summary sensitivity and specificity estimates for TCD and TCCD were 95% (95% CI = 0.83 to 0.99) and 95% (95% CI = 0.90 to 0.98), respectively. Considering a prevalence of stenosis or occlusion of 42% (as reported in the literature), for every 1000 people who receive a TCD or TCCD test, stenosis or occlusion will be missed in 21 people (95% CI = 4 to 71) and 29 (95% CI = 12 to 58) will be wrongly diagnosed as harbouring an intracranial occlusion. However, there was substantial heterogeneity between studies, which was no longer evident when only occlusion of the MCA was considered, or when the analysis was limited to participants investigated within six hours. The performance of either TCD or TCCD in ruling in and ruling out a MCA occlusion was good. Limitations of this review were the small number of identified studies and the lack of data on the use of ultrasound contrast medium.\nAuthors' conclusions\nThis review provides evidence that TCD or TCCD, administered by professionals with adequate experience and skills, can provide useful diagnostic information for detecting stenosis or occlusion of intracranial vessels in people with acute ischaemic stroke, or guide the request for more invasive vascular neuroimaging, especially where CT or MR-based vascular imaging are not immediately available. More studies are needed to confirm or refute the results of this review in a larger sample of stroke patients, to verify the role of contrast medium and to evaluate the clinical advantage of the use of ultrasound.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The main limitation of this review is the small number of people assessed by TCD and TCCD in the individual studies. Not enough people have been studied to be really confident about these results. Further larger studies are needed to confirm or refute these results."
}
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query-laysum | 2454 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with cystic fibrosis (CF) and pancreatic insufficiency are at risk of a deficiency in fat-soluble vitamins, including vitamin A. Vitamin A deficiency predominantly causes eye and skin problems, while excessive levels of vitamin A can harm the respiratory and skeletal systems in children and interfere with the metabolism of other fat-soluble vitamins. Most CF centres administer vitamin A as supplements to reduce the frequency of vitamin A deficiency in people with CF and to improve clinical outcomes such as growth, although the recommended dose varies between different guidelines. Thus, a systematic review on vitamin A and vitamin A-like supplementation (carotenes or other retinoids) in people with CF would help guide clinical practice. This is an update of an earlier Cochrane Review.\nObjectives\nTo determine if supplementation with vitamin A, carotenes or other retinoid supplements in children and adults with CF reduces the frequency of vitamin A deficiency disorders, improves general and respiratory health and affects the frequency of vitamin A toxicity.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Cystic Fibrosis Trials Register compiled from electronic database searches and handsearching of journals and conference abstract books. Additionally we searched several ongoing trials registries, including ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform and the International Standard Randomised Controlled Trial Number Registry.\nMost recent database searches: 01 June 2018.\nSelection criteria\nAll randomised or quasi-randomised controlled studies comparing all preparations of oral vitamin A, carotenes or retinoids (or in combination), used as a supplement compared to placebo at any dose, for at least three months, in people with CF (diagnosed by sweat tests or genetic testing) with and without pancreatic insufficiency.\nData collection and analysis\nTwo authors individually assessed study quality and extracted data on outcome measures. The authors assessed the quality of the evidence using the GRADE system. Investigators were contacted to retrieve missing quantitative data.\nMain results\nNo studies of vitamin A or other retinoid supplementation were eligible for inclusion. However, one randomised study of beta (β)-carotene supplementation involving 24 people with CF who were receiving pancreatic enzyme substitution was included. The study compared successive β-carotene supplementation periods (high dose followed by low dose) compared to placebo. The results for the low-dose supplementation period should be interpreted with caution, due to the lack of a wash-out period after the high-dose supplementation.\nThe included study did not report on two of the review's primary outcomes (vitamin A deficiency disorders and mortality); results for our third primary outcome of growth and nutritional status (reported as z score for height) showed no difference between supplementation and placebo, mean difference (MD) -0.23 (95% confidence interval (CI) -0.89 to 0.43) (low-quality evidence). With regards to secondary outcomes, supplementation with high-dose β-carotene for three months led to significantly fewer days of systemic antibiotics required to treat pulmonary exacerbations, compared to controls, MD -15 days (95% CI -27.60 to -2.40); however, this was not maintained in the second three-month section of the study when the level of β-carotene supplementation was reduced, MD -8 days (95% CI -18.80 to 2.80) (low-quality evidence). There were no statistically significant effects between groups in lung function (low-quality evidence) and no adverse events were observed (low-quality evidence). Supplementation affected levels of β-carotene in plasma, but not vitamin A levels. The study did not report on quality of life or toxicity.\nAuthors' conclusions\nSince no randomised or quasi-randomised controlled studies on retinoid supplementation were identified, no conclusion on the supplementation of vitamin A in people with CF can be drawn. Additionally, due to methodological limitations in the included study, also reflected in the low-quality evidence judged following the specific evidence grading system (GRADE), no clear conclusions on β-carotene supplementation can be drawn. Until further data are available, country- or region-specific guidelines regarding these practices should be followed.\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 could only include one study in this review and that study had several limitations. This is reflected in the assessment of low-quality evidence, judged using the specific evidence grading system (GRADE). So, we feel that the strength of evidence is low. Not all outcome measures were reported after each supplementation dose and results should be viewed with some caution as some beta-carotene from the high-dose period was probably still present in the blood during the low-dose supplementation period."
}
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query-laysum | 2455 | [
{
"role": "user",
"content": "Abstract: Background\nDespite local therapies, commonly transurethral resection (TUR) followed by adjuvant treatments, non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence and progression. Intravesical Bacillus Calmette-Guérin (BCG) has been shown to reduce recurrence and progression in people with NMIBC following TUR, however many people do not respond to treatment, have recurrence shortly after, or cannot tolerate standard-dose therapy. The potential for synergistic antitumour activity of interferon (IFN)-alpha (α) and BCG provides some rationale for combination therapy for people who do not tolerate or respond to standard-dose BCG therapy.\nObjectives\nTo assess the effects of intravesically administered BCG plus IFN-α compared with BCG alone for treating non-muscle-invasive bladder cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2016), MEDLINE (OvidSP) (1946 to 2016), Embase (OvidSP) (1974 to 2016), ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) as well as reference lists of retrieved articles and handsearched abstract proceedings of relevant conferences for the past three years. We applied no language restrictions. The date of last search of all databases was 25 August 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) and pseudo-randomised trials assessing intravesically administered BCG plus IFN-α versus BCG alone in adults of either gender with histologically confirmed Ta and T1 superficial bladder cancer, with or without carcinoma in situ, treated with TUR.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed the risk of bias of included studies. We used Review Manager 5 for data synthesis and employed the random-effects model for meta-analyses. For prespecified outcomes, where we were unable to derive time-to-event information (e.g. time-to-recurrence), we assessed dichotomous outcomes (e.g. recurrence) instead. We assessed the quality of the evidence for the main comparisons using the GRADE approach.\nMain results\nWe included five RCTs involving a total of 1231 participants with NMIBC in this review. Due to poor reporting, the risk of bias in the included studies was often unclear. We assessed the studies under two main comparisons: intravesical BCG plus IFN-α versus intravesical BCG alone (four RCTs), and intravesical BCG alternating with IFN-α versus intravesical BCG alone (one RCT).\nIntravesical BCG plus IFN-α versus intravesical BCG alone (four RCTs): We observed no clear difference between BCG plus IFN-α and BCG alone for recurrence (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.44 to 1.32; 4 RCTs; 925 participants; very low-quality evidence) or progression (average RR 0.26, 95% CI 0.04 to 1.87; 2 RCTs; 219 participants; low-quality evidence). The included RCTs did not report on the other primary outcome of this review, discontinuation of therapy due to adverse events. Regarding secondary outcomes, we observed no clear difference for disease-specific mortality (RR 0.38, 95% CI 0.05 to 3.05; 1 RCT; 99 participants; very low-quality evidence). Two RCTs reporting contradictory findings for adverse events could not be pooled due to variation in definitions. There were no data from the included RCTs on time-to-death or disease-specific quality of life.\nIntravesical BCG alternating with IFN-α versus intravesical BCG alone (one RCT): We observed shorter time-to-recurrence for participants in the BCG alternating with IFN-α group compared with the BCG alone group (hazard ratio (HR) 2.86, 95% CI 1.98 to 4.13; 1 RCT; 205 participants; low-quality evidence), but no clear differences in time-to-progression (HR 2.39, 95% CI 0.92 to 6.21; 1 RCT; 205 participants; low-quality evidence) and discontinuation of therapy due to adverse events (RR 2.97, 95% CI 0.31 to 28.09; 1 RCT; 205 participants; low-quality evidence). Regarding secondary outcomes, there were no clear differences between the BCG alternating with IFN-α and BCG alone groups for disease-specific mortality (HR 2.74, 95% CI 0.73 to 10.28; 1 RCT; 205 participants; low-quality evidence), time-to-death (overall survival) (HR 1.00, 95% CI 0.68 to 1.47; 1 RCT; 205 participants; low-quality evidence), or systemic or local adverse events (RR 1.65, 95% CI 0.41 to 6.73; 1 RCT; 205 participants; low-quality evidence). There were no data on disease-specific quality of life.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting no clear differences in recurrence or progression with BCG plus IFN-α compared with BCG alone for people with NMIBC; there was no information to determine the effect on discontinuation of therapy due to adverse events. Low-quality evidence suggests BCG alternating with IFN-α compared with BCG alone may increase time-to-recurrence, however low-quality evidence also suggests no clear differences for time-to-progression or discontinuation of therapy due to adverse events.\nAdditional high-quality, adequately powered trials using standardised instillation regimens and doses of both BCG and IFN-α, reporting outcomes in subgroups stratified by patient and tumour characteristics, and on long-term outcomes related not only to recurrence but also to progression, discontinuation due to adverse events, and mortality may help to clarify the ideal treatment strategy and provide a more definitive result.\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": "Bladder cancer is a common cancer worldwide. Bladder cancer that is non-muscle invasive is often treated with resection (removal by surgery), but it has a high risk of recurring and progressing to more invasive disease with that treatment alone. Bacillus Calmette-Guérin is a treatment that is commonly administered into the bladder after resection to reduce the risk of recurrence and progression. Some non-randomised studies have shown that adding IFN-α to BCG may further reduce these risks. We aimed to compare the effects of BCG with IFN-α versus BCG alone administered into the bladder in the treatment of people with non-muscle-invasive bladder cancer."
}
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query-laysum | 2456 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of \"Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults\" last updated in Issue 4, 2009. Ketoprofen is a non-selective nonsteroidal anti-inflammatory drug (NSAID) used to treat acute and chronic painful conditions. Dexketoprofen is the (S)-enantiomer, which is believed to confer analgesia. Theoretically dexketoprofen is expected to provide equivalent analgesia to ketoprofen at half the dose, with a consequent reduction in gastrointestinal adverse events. This review is one of a series on oral analgesics for acute postoperative pain. Individual reviews have been brought together in two overviews to provide information about the relative efficacy and harm of the different interventions.\nObjectives\nTo assess the efficacy and safety of single dose oral ketoprofen and oral dexketoprofen compared with placebo for acute postoperative pain, using methods that permit comparison with other analgesics evaluated in the same way, and criteria of efficacy recommended by an in-depth study at the individual patient level.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from 2009 to 28 March 2017. We also searched the reference lists of retrieved studies and reviews, and two online clinical trial registries.\nSelection criteria\nRandomised, double-blind, placebo-controlled trials of single dose orally administered ketoprofen or dexketoprofen in adults with moderate to severe acute postoperative pain.\nData collection and analysis\nTwo review authors independently considered studies for inclusion in the review, examined issues of study quality and potential bias, and extracted data. For dichotomous outcomes, we calculated risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH) with 95% confidence intervals (CI) for ketoprofen and dexketoprofen, compared with placebo, where there were sufficient data. We collected information on the number of participants with at least 50% of the maximum possible pain relief over six hours, the median time to use of rescue medication, and the proportion of participants requiring rescue medication. We also collected information on adverse events and withdrawals. We assessed the quality of the evidence using GRADE, and created 'Summary of findings' tables.\nMain results\nThis updated review included 24 studies; six additional studies added 1001 participants involved in comparisons of ketoprofen or dexketoprofen and placebo, with a 12% increase in participants taking ketoprofen and a 65% increase for dexketoprofen. Most participants (70%) were women. Dental studies typically involved young participants (mean age 20 to 30 years); other types of surgery involved older participants (mean age 37 to 68 years). Overall, we judged the studies at high risk of bias only for small size, which can lead to an overestimation of benefit.\nKetoprofen doses ranged between 6.5 mg and 150 mg. The proportion of participants achieving at least 50% pain relief over six hours with the usual ketoprofen oral dose of 50 mg was 57%, compared to 23% with placebo, giving an NNT of 2.9 (95% CI 2.4 to 3.7) (RR 2.5, 95% CI 2.0 to 3.1; 594 participants; 8 studies; high quality evidence). Efficacy was significantly better in dental studies (NNT 1.8) than other surgery (NNT 4.2). The proportion of participants using rescue medication within six hours was lower with ketoprofen (32%) than with placebo (75%), giving a number needed to treat to prevent use of rescue medication (NNTp) of 2.3 (95% CI 1.8 to 3.1); 263 participants; 4 studies; high quality evidence). Median time to remedication estimates were poorly reported. Reports of any adverse event were similar with ketoprofen (18%) and placebo (11%) (RR 1.6, 95% CI 0.98 to 2.8; 342 participants; 5 studies; high quality evidence). No study reported any serious adverse events (very low quality evidence).\nDexketoprofen doses ranged between 5 mg and 100 mg. The proportion of participants achieving at least 50% pain relief over six hours with the usual dexketoprofen oral dose of 20 mg or 25 mg was 52%, compared to 27% with placebo, giving an NNT of 4.1 (95% CI 3.3 to 5.2) (RR 2.0, 95% CI 1.6 to 2.2; 1177 participants; 8 studies; high quality evidence). Efficacy was significantly better in dental studies (NNT 2.7) than other surgery (NNT 5.7). The proportion of participants using rescue medication within six hours was lower with dexketoprofen (47%) than placebo (69%), giving an NNTp of 4.7 (95% CI 3.3 to 8.0); 445 participants; 5 studies; high quality evidence). Median time to remedication estimates were poorly reported. Reports of any adverse event were similar with dexketoprofen (14%) and placebo (10%) (RR 1.4, 95% CI 0.89 to 2.2; 536 participants, 6 studies; high quality evidence). No study reported any serious adverse events (very low quality evidence).\nAuthors' conclusions\nKetoprofen at doses of 25 mg to 100 mg is an effective analgesic in moderate to severe acute postoperative pain with an NNT for at least 50% pain relief of 2.9 with a 50 mg dose. This is similar to that of commonly used NSAIDs such as ibuprofen (NNT 2.5 for 400 mg dose) and diclofenac (NNT 2.7 for 50 mg dose). Dexketoprofen is also effective with an NNT of 4.1 in the dose range 10 mg to 25 mg. Differential efficacy between dental surgery and other types of surgery seen for both drugs is unusual. Both drugs were well tolerated in single doses.\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 March 2017, we found 24 studies involving 5220 people. The main comparison was between usual oral doses of ketoprofen 50 mg and placebo, and dexketoprofen 25 mg and placebo. The studies tested single doses after wisdom tooth extraction, and after other types of surgery, mainly hip replacement and gynaecological operations. Studies included adults over a range of ages, and 7 out of 10 participants were women. The main outcome was participants having at least half of the maximum possible pain relief over the first six hours after taking the tablets."
}
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query-laysum | 2457 | [
{
"role": "user",
"content": "Abstract: Background\nCannabis has a long history of medicinal use. Cannabis-based medications (cannabinoids) are based on its active element, delta-9-tetrahydrocannabinol (THC), and have been approved for medical purposes. Cannabinoids may be a useful therapeutic option for people with chemotherapy-induced nausea and vomiting that respond poorly to commonly used anti-emetic agents (anti-sickness drugs). However, unpleasant adverse effects may limit their widespread use.\nObjectives\nTo evaluate the effectiveness and tolerability of cannabis-based medications for chemotherapy-induced nausea and vomiting in adults with cancer.\nSearch methods\nWe identified studies by searching the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and LILACS from inception to January 2015. We also searched reference lists of reviews and included studies. We did not restrict the search by language of publication.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared a cannabis-based medication with either placebo or with a conventional anti-emetic in adults receiving chemotherapy.\nData collection and analysis\nAt least two review authors independently conducted eligibility and risk of bias assessment, and extracted data. We grouped studies based on control groups for meta-analyses conducted using random effects. We expressed efficacy and tolerability outcomes as risk ratio (RR) with 95% confidence intervals (CI).\nMain results\nWe included 23 RCTs. Most were of cross-over design, on adults undergoing a variety of chemotherapeutic regimens ranging from moderate to high emetic potential for a variety of cancers. The majority of the studies were at risk of bias due to either lack of allocation concealment or attrition. Trials were conducted between 1975 and 1991. No trials involved comparison with newer anti-emetic drugs such as ondansetron.\nComparison with placebo\nPeople had more chance of reporting complete absence of vomiting (3 trials; 168 participants; RR 5.7; 95% CI 2.6 to 12.6; low quality evidence) and complete absence of nausea and vomiting (3 trials; 288 participants; RR 2.9; 95% CI 1.8 to 4.7; moderate quality evidence) when they received cannabinoids compared with placebo. The percentage of variability in effect estimates that was due to heterogeneity rather than chance was not important (I2 = 0% in both analyses).\nPeople had more chance of withdrawing due to an adverse event (2 trials; 276 participants; RR 6.9; 95% CI 1.96 to 24; I2 = 0%; very low quality evidence) and less chance of withdrawing due to lack of efficacy when they received cannabinoids, compared with placebo (1 trial; 228 participants; RR 0.05; 95% CI 0.0 to 0.89; low quality evidence). In addition, people had more chance of 'feeling high' when they received cannabinoids compared with placebo (3 trials; 137 participants; RR 31; 95% CI 6.4 to 152; I2 = 0%).\nPeople reported a preference for cannabinoids rather than placebo (2 trials; 256 participants; RR 4.8; 95% CI 1.7 to 13; low quality evidence).\nComparison with other anti-emetics\nThere was no evidence of a difference between cannabinoids and prochlorperazine in the proportion of participants reporting no nausea (5 trials; 258 participants; RR 1.5; 95% CI 0.67 to 3.2; I2 = 63%; low quality evidence), no vomiting (4 trials; 209 participants; RR 1.11; 95% CI 0.86 to 1.44; I2 = 0%; moderate quality evidence), or complete absence of nausea and vomiting (4 trials; 414 participants; RR 2.0; 95% CI 0.74 to 5.4; I2 = 60%; low quality evidence). Sensitivity analysis where the two parallel group trials were pooled after removal of the five cross-over trials showed no difference (RR 1.1; 95% CI 0.70 to 1.7) with no heterogeneity (I2 = 0%).\nPeople had more chance of withdrawing due to an adverse event (5 trials; 664 participants; RR 3.9; 95% CI 1.3 to 12; I2 = 17%; low quality evidence), due to lack of efficacy (1 trial; 42 participants; RR 3.5; 95% CI 1.4 to 8.9; very low quality evidence) and for any reason (1 trial; 42 participants; RR 3.5; 95% CI 1.4 to 8.9; low quality evidence) when they received cannabinoids compared with prochlorperazine.\nPeople had more chance of reporting dizziness (7 trials; 675 participants; RR 2.4; 95% CI 1.8 to 3.1; I2 = 12%), dysphoria (3 trials; 192 participants; RR 7.2; 95% CI 1.3 to 39; I2 = 0%), euphoria (2 trials; 280 participants; RR 18; 95% CI 2.4 to 133; I2 = 0%), 'feeling high' (4 trials; 389 participants; RR 6.2; 95% CI 3.5 to 11; I2 = 0%) and sedation (8 trials; 947 participants; RR 1.4; 95% CI 1.2 to 1.8; I2 = 31%), with significantly more participants reporting the incidence of these adverse events with cannabinoids compared with prochlorperazine.\nPeople reported a preference for cannabinoids rather than prochlorperazine (7 trials; 695 participants; RR 3.3; 95% CI 2.2 to 4.8; I2 = 51%; low quality evidence).\nIn comparisons with metoclopramide, domperidone and chlorpromazine, there was weaker evidence, based on fewer trials and participants, for higher incidence of dizziness with cannabinoids.\nTwo trials with 141 participants compared an anti-emetic drug alone with a cannabinoid added to the anti-emetic drug. There was no evidence of differences between groups; however, the majority of the analyses were based on one small trial with few events.\nQuality of the evidence\nThe trials were generally at low to moderate risk of bias in terms of how they were designed and do not reflect current chemotherapy and anti-emetic treatment regimens. Furthermore, the quality of evidence arising from meta-analyses was graded as low for the majority of the outcomes analysed, indicating that we are not very confident in our ability to say how well the medications worked. Further research is likely to have an important impact on the results.\nAuthors' conclusions\nCannabis-based medications may be useful for treating refractory chemotherapy-induced nausea and vomiting. However, methodological limitations of the trials limit our conclusions and further research reflecting current chemotherapy regimens and newer anti-emetic drugs is likely to modify these conclusions.\n\nGiven the provided abstract, please respond to the following query: \"Main findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review of 23 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) found that fewer people who received cannabis-based medicines experienced nausea and vomiting than people who received placebo (a pretend medicine). The proportion of people who experienced nausea and vomiting who received cannabis-based medicines was similar to conventional anti-nausea medicines. However, more people experienced side effects such as 'feeling high', dizziness, sedation (feeling relaxed or sleepy) and dysphoria (feeling uneasy or dissatisfied) and left the study due to the side effects with cannabis-based medicines, compared with either placebo or other anti-nausea medicines. In trials where people received cannabis-based medicines and conventional medicines in turn, overall people preferred the cannabis-based medicines."
}
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query-laysum | 2458 | [
{
"role": "user",
"content": "Abstract: Background\nRegular blood pressure (BP) measurement is crucial for the diagnosis and management of hypertensive disorders in pregnancy, such as pre-eclampsia. BP can be measured in various settings, such as conventional clinics or self-measurement at home, and with different techniques, such as using auscultatory or automated BP devices. It is important to understand the impact of different settings and techniques of BP measurement on important outcomes for pregnant women.\nObjectives\nTo assess the effects of setting and technique of BP measurement for diagnosing hypertensive disorders in pregnancy on subsequent maternal and perinatal outcomes, women's quality of life, or use of health service resources.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) on 22 April 2020, and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) involving pregnant women, using validated BP devices in different settings or using different techniques.\nData collection and analysis\nTwo authors independently extracted data, assessed risk of bias, and used the GRADE approach to assess the certainty of the evidence.\nMain results\nOf the 21 identified studies, we included three, and excluded 11; seven were ongoing. Of the three included RCTs (536,607 women), one was a cluster-RCT, with a substantially higher number of participants (536,233 deliveries) than the other two trials, but did not provide data for most of our outcomes. We generally judged the included studies at low risk of bias, however, the certainty of the evidence was low, due to indirectness and imprecision. Meta-analysis was not possible because each study investigated a different comparison.\nNone of the included studies reported our primary outcome of systolic BP greater than or equal to 150 mmHg. None of the studies reported any of these important secondary outcomes: antenatal hospital admissions, neonatal unit length of stay, or neonatal endotracheal intubation and use of mechanical ventilation.\nSetting of BP measurement: self-measurement versus conventional clinic measurement (one study, 154 women)\nThere were no maternal deaths in either the self-monitoring group or the usual care group. The study did not report perinatal mortality.\nSelf-monitoring may lead to slightly more diagnoses of pre-eclampsia compared with usual care (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.87 to 2.54; 154 women; 1 study; low-certainty evidence) but the wide 95% CI is consistent with possible benefit and possible harm.\nSelf-monitoring may have little to no effect on the likelihood of induction of labour compared with usual care (RR 1.09, 95% CI 0.82 to 1.45; 154 women; 1 study; low-certainty evidence).\nWe are uncertain if self-monitoring BP has any effect on maternal admission to intensive care (RR 1.54, 95% CI 0.06 to 37.25; 154 women; 1 study; low-certainty evidence), stillbirth (RR 2.57, 95% CI 0.13 to 52.63; 154 women; 1 study; low-certainty evidence), neonatal death (RR 1.54, 95% CI 0.06 to 37.25; 154 women; 1 study; low-certainty evidence) or preterm birth (RR 1.15, 95% CI 0.37 to 3.55; 154 women; 1 study; low-certainty evidence), compared with usual care because the certainty of evidence is low and the 95% CI is consistent with appreciable harms and appreciable benefits.\nSelf-monitoring may lead to slightly more neonatal unit admissions compared with usual care (RR 1.53, 95% CI 0.65 to 3.62; 154 women; 1 study; low-certainty evidence) but the wide 95% CI includes the possibility of slightly fewer admissions with self-monitoring.\nTechnique of BP measurement: Korotkoff phase IV (K4, muffling sound) versus Korotkoff phase V (K5, disappearance of sound) to represent diastolic BP (one study, 220 women)\nThere were no maternal deaths in either the K4 or K5 group.\nThere may be little to no difference in the diagnosis of pre-eclampsia between using K4 or K5 for diastolic BP (RR 1.16; 95% CI 0.89 to 1.49; 1 study; 220 women; low-certainty evidence), since the wide 95% CI includes the possibility of more diagnoses with K4.\nWe are uncertain if there is a difference in perinatal mortality between the groups because the quality of evidence is low and the 95% CI is consistent with appreciable harm and appreciable benefit (RR 1.14, 95% CI 0.16 to 7.92; 1 study, 220 women; low-certainty evidence).\nThe trial did not report data on maternal admission to intensive care, induction of labour, stillbirth, neonatal death, preterm birth, or neonatal unit admissions.\nTechnique of BP measurement: CRADLE intervention (CRADLE device, a semi-automated BP monitor with additional features, and an education package) versus usual care (one study, 536,233 deliveries)\nThere may be little to no difference between the use of the CRADLE device and usual care in the number of maternal deaths (adjusted RR 0.80, 95% CI 0.30 to 2.11; 536,233 women; 1 study; low-certainty evidence), but the 95% CI is consistent with appreciable harm and appreciable benefit.\nThe trial did not report pre-eclampsia, induction of labour, perinatal mortality, preterm birth, or neonatal unit admissions. Maternal admission to intensive care and perinatal outcomes (stillbirths and neonatal deaths) were only collected for a small proportion of the women, identified by an outcome not by baseline characteristics, thereby breaking the random allocation. Therefore, any differences between the groups could not be attributed to the intervention, and we did not extract data for these outcomes.\nAuthors' conclusions\nThe benefit, if any, of self-monitoring BP in hypertensive pregnancies remains uncertain, as the evidence is limited to one feasibility study. Current practice of using K5 to measure diastolic BP is supported for women with pregnancy hypertension. The benefit, if any, of using the CRADLE device to measure BP in pregnancy remains uncertain, due to the limitations and instability of the trial study design.\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"
},
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"role": "assistant",
"content": "More evidence is needed on whether self-monitoring BP in pregnant women with high BP is beneficial, because the study exploring this was small.\nCurrent practice of using K5 (no blood flow sound) to measure diastolic BP is supported in pregnant women with high BP.\nThe trial using the CRADLE device to monitor BP in pregnancy had limitations in its design, and we are uncertain about its benefit."
}
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query-laysum | 2459 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes mellitus, a metabolic disorder characterised by hyperglycaemia and associated with a heavy burden of microvascular and macrovascular complications, frequently remains undiagnosed. Screening of apparently healthy individuals may lead to early detection and treatment of type 2 diabetes mellitus and may prevent or delay the development of related complications.\nObjectives\nTo assess the effects of screening for type 2 diabetes mellitus.\nSearch methods\nWe searched CENTRAL, MEDLINE, LILACS, the WHO ICTRP, and ClinicalTrials.gov from inception. The date of the last search was May 2019 for all databases. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials involving adults and children without known diabetes mellitus, conducted over at least three months, that assessed the effect of diabetes screening (mass, targeted, or opportunistic) compared to no diabetes screening.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for potential relevance and reviewed the full-texts of potentially relevant studies, extracted data, and carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool. We assessed the overall certainty of the evidence using the GRADE approach.\nMain results\nWe screened 4651 titles and abstracts identified by the search and assessed 92 full-texts/records for inclusion. We included one cluster-randomised trial, the ADDITION-Cambridge study, which involved 20,184 participants from 33 general practices in Eastern England and assessed the effects of inviting versus not inviting high-risk individuals to screening for diabetes. The diabetes risk score was used to identify high-risk individuals; it comprised variables relating to age, sex, body mass index, and the use of prescribed steroid and anti-hypertensive medication. Twenty-seven practices were randomised to the screening group (11,737 participants actually attending screening) and 5 practices to the no-screening group (4137 participants). In both groups, 36% of participants were women; the average age of participants was 58.2 years in the screening group and 57.9 years in the no-screening group. Almost half of participants in both groups were on antihypertensive medication. The findings from the first phase of this study indicate that screening compared to no screening for type 2 diabetes did not show a clear difference in all-cause mortality (hazard ratio (HR) 1.06, 95% confidence interval (CI) 0.90 to 1.25, low-certainty evidence). Screening compared to no screening for type 2 diabetes mellitus showed an HR of 1.26, 95% CI 0.75 to 2.12 (low-certainty evidence) for diabetes-related mortality (based on whether diabetes was reported as a cause of death on the death certificate). Diabetes-related morbidity and health-related quality of life were only reported in a subsample and did not show a substantial difference between the screening intervention and control. The included study did not report on adverse events, incidence of type 2 diabetes, glycosylated haemoglobin A1c (HbA1c), and socioeconomic effects.\nAuthors' conclusions\nWe are uncertain about the effects of screening for type 2 diabetes on all-cause mortality and diabetes-related mortality. Evidence was available from one study only. We are therefore unable to draw any firm conclusions relating to the health outcomes of early type 2 diabetes mellitus screening. Furthermore, the included study did not assess all of the outcomes prespecified in the review (diabetes-related morbidity, incidence of type 2 diabetes, health-related quality of life, adverse events, socioeconomic effects).\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What are the health effects of screening compared to not screening for type 2 diabetes mellitus?"
}
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query-laysum | 2460 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in Issue 12, 2016. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy, the majority of which may be able to achieve remission with a single antiepileptic drug (AED).\nThe correct choice of first-line AED for individuals with newly diagnosed seizures is of great importance and should be based on the highest-quality evidence available regarding the potential benefits and harms of various treatments for an individual.\nTopiramate and carbamazepine are commonly used AEDs. Performing a synthesis of the evidence from existing trials will increase the precision of results of outcomes relating to efficacy and tolerability, and may help inform a choice between the two drugs.\nObjectives\nTo review the time to treatment failure, remission and first seizure with topiramate compared with carbamazepine when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nFor the latest update we searched the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid); ClinicalTrials.gov; and the WHO International Clinical Trials Registry Platform (ICTRP) to 22 May 2018. We imposed no language restrictions. We also contacted pharmaceutical companies and trial investigators.\nSelection criteria\nRandomised controlled trials (RCTs) comparing monotherapy with either topiramate or carbamazepine in children or adults with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nData collection and analysis\nThis was an individual participant data (IPD), review. Our primary outcome was time to treatment failure. Our secondary outcomes were time to first seizure post-randomisation, time to six-month remission, time to 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs), with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nIPD were available for 1151 of 1239 eligible individuals from two of three eligible studies (93% of the potential data). A small proportion of individuals recruited into these trials had 'unclassified seizures;' for analysis purposes, these individuals are grouped with those with generalised onset seizures. For remission outcomes, a HR < 1 indicated an advantage for carbamazepine, and for first seizure and treatment failure outcomes, a HR < 1 indicated an advantage for topiramate.\nThe main overall results for the primary outcome, time to treatment failure, given as pooled HR adjusted for seizure type were: time to failure for any reason related to treatment 1.16 (95% CI 0.97 to 1.38); time to failure due to adverse events 1.02 (95% CI 0.82 to 1.27); and time to failure due to lack of efficacy 1.46 (95% CI 1.08 to 1.98). Overall results for secondary outcomes were time to first seizure 1.11 (95% CI 0.96 to 1.29); and time to six-month remission 0.88 (0.76 to 1.01). There were no statistically significant differences between the drugs. A statistically significant advantage for carbamazepine was shown for time to 12-month remission: 0.84 (95% CI 0.71 to 0.99).\nThe results of this review are applicable mainly to individuals with focal onset seizures; 81% of individuals included within the analysis experienced seizures of this type at baseline. For individuals with focal onset seizures, a statistically significant advantage for carbamazepine was shown for time to failure for any reason related to treatment (HR 1.21, 95% CI 1.01 to 1.46), time to treatment failure due to lack of efficacy (HR 1.47, 95% CI 1.07 to 2.02), and time to 12-month remission (HR 0.82, 95% CI 0.69 to 0.99). There was no statistically significant difference between topiramate and carbamazepine for 'time to first seizure' and 'time to six-month remission'.\nEvidence for individuals with generalised tonic-clonic seizures (9% of participants contributing to the analysis), and unclassified seizure types (10% of participants contributing to the analysis) was very limited; no statistically significant differences were found but CIs were wide; therefore we cannot exclude an advantage to either drug, or a difference between drugs.\nThe most commonly reported adverse events with both drugs were drowsiness or fatigue, \"pins and needles\" (tingling sensation), headache, gastrointestinal disturbance and anxiety or depression. The rate of adverse events was similar across the two drugs.\nWe judged the methodological quality of the included trials generally to be good; however, there was some evidence that the open-label design of the larger of the two trials may have influenced the treatment failure rate within the trial. Hence, we judged the certainty of the evidence for treatment failure to be moderate for individuals with focal onset seizures and low for individuals with generalised onset seizures. For efficacy outcomes (first seizure, remission), we judged the certainty of evidence from this review to be high for individuals with focal onset seizures and moderate for individuals with generalised onset or unclassified seizures.\nAuthors' conclusions\nFor individuals with focal onset seizures, there is moderate-certainty evidence that carbamazepine is less likely to be withdrawn and high-certainty evidence that 12-month remission will be achieved earlier than with topiramate. We did not find any differences between the drugs in terms of the other outcomes measured in the review and for individuals with generalised tonic-clonic seizures or unclassified epilepsy; however, we encourage caution in the interpretation of results including small numbers of participants with these seizure types.\nFuture trials should be designed to the highest quality possible and take into consideration masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Topiramate and carbamazepine are commonly used treatments for individuals with epilepsy. The aim of this review was to compare how effective these drugs are at controlling recently diagnosed seizures, whether they are associated with side effects that may result in individuals stopping the drug and to inform a choice between these drugs."
}
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query-laysum | 2461 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the first update of a review published in 2010. While calcium channel blockers (CCBs) are often recommended as a first-line drug to treat hypertension, the effect of CCBs on the prevention of cardiovascular events, as compared with other antihypertensive drug classes, is still debated.\nObjectives\nTo determine whether CCBs used as first-line therapy for hypertension are different from other classes of antihypertensive drugs in reducing the incidence of major adverse cardiovascular events.\nSearch methods\nFor this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials (RCTs) up to 1 September 2020: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 1), Ovid MEDLINE, Ovid Embase, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted the authors of relevant papers regarding further published and unpublished work and checked the references of published studies to identify additional trials. The searches had no language restrictions.\nSelection criteria\nRandomised controlled trials comparing first-line CCBs with other antihypertensive classes, with at least 100 randomised hypertensive participants and a follow-up of at least two years.\nData collection and analysis\nThree review authors independently selected the included trials, evaluated the risk of bias, and entered the data for analysis. Any disagreements were resolved through discussion. We contacted study authors for additional information.\nMain results\nThis update contains five new trials. We included a total of 23 RCTs (18 dihydropyridines, 4 non-dihydropyridines, 1 not specified) with 153,849 participants with hypertension. All-cause mortality was not different between first-line CCBs and any other antihypertensive classes. As compared to diuretics, CCBs probably increased major cardiovascular events (risk ratio (RR) 1.05, 95% confidence interval (CI) 1.00 to 1.09, P = 0.03) and increased congestive heart failure events (RR 1.37, 95% CI 1.25 to 1.51, moderate-certainty evidence). As compared to beta-blockers, CCBs reduced the following outcomes: major cardiovascular events (RR 0.84, 95% CI 0.77 to 0.92), stroke (RR 0.77, 95% CI 0.67 to 0.88, moderate-certainty evidence), and cardiovascular mortality (RR 0.90, 95% CI 0.81 to 0.99, low-certainty evidence). As compared to angiotensin-converting enzyme (ACE) inhibitors, CCBs reduced stroke (RR 0.90, 95% CI 0.81 to 0.99, low-certainty evidence) and increased congestive heart failure (RR 1.16, 95% CI 1.06 to 1.28, low-certainty evidence). As compared to angiotensin receptor blockers (ARBs), CCBs reduced myocardial infarction (RR 0.82, 95% CI 0.72 to 0.94, moderate-certainty evidence) and increased congestive heart failure (RR 1.20, 95% CI 1.06 to 1.36, low-certainty evidence).\nAuthors' conclusions\nFor the treatment of hypertension, there is moderate certainty evidence that diuretics reduce major cardiovascular events and congestive heart failure more than CCBs. There is low to moderate certainty evidence that CCBs probably reduce major cardiovascular events more than beta-blockers. There is low to moderate certainty evidence that CCBs reduced stroke when compared to angiotensin-converting enzyme (ACE) inhibitors and reduced myocardial infarction when compared to angiotensin receptor blockers (ARBs), but increased congestive heart failure when compared to ACE inhibitors and ARBs. Many of the differences found in the current review are not robust, and further trials might change the conclusions. More well-designed RCTs studying the mortality and morbidity of individuals taking CCBs as compared with other antihypertensive drug classes are needed for patients with different stages of hypertension, different ages, and with different comorbidities such as diabetes.\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"
},
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"role": "assistant",
"content": "We assessed the quality of the evidence as mostly moderate, although more trials are desirable."
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query-laysum | 2462 | [
{
"role": "user",
"content": "Abstract: Background\nPneumonia is a leading cause of morbidity and mortality in children younger than five years of age. Most deaths occur during infancy and in low-income countries. Daily zinc supplements have been reported to prevent acute lower respiratory tract infection (LRTI) and reduce child mortality. This is an update of a review first published in 2010.\nObjectives\nTo evaluate the effectiveness of zinc supplementation in the prevention of pneumonia in children aged two to 59 months.\nSearch methods\nWe searched CENTRAL (Issue 21 October 2016), MEDLINE (1966 to October 2016), Embase (1974 to October 2016), LILACS (1982 to October 2016), CINAHL (1981 to October 2016), Web of Science (1985 to October 2016) and IMSEAR (1980 to October 2016).\nSelection criteria\nRandomised controlled trials (RCTs) evaluating zinc supplementation for the prevention of pneumonia in children aged from 2 months to 59 months.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data.\nMain results\nWe did not identify any new studies for inclusion in this update. We included six studies that involved 5193 participants.\nAnalysis showed that zinc supplementation reduced the incidence of pneumonia by 13% (fixed-effect risk ratio (RR) 0.87; 95% confidence interval (CI) 0.81 to 0.94, six studies, low-quality evidence) and prevalence of pneumonia by 41% (random-effects RR 0.59; 95% CI 0.35 to 0.99, one study, n = 609, low-quality evidence). On subgroup analysis, we found that zinc reduced the incidence of pneumonia defined by specific clinical criteria by 21% (i.e. confirmation by chest examination or chest radiograph) (fixed-effect RR 0.79; 95% CI 0.71 to 0.88, four studies, n = 3261), but had no effect on lower specificity pneumonia case definition (i.e. age-specific fast breathing with or without lower chest indrawing) (fixed-effect RR 0.95; 95% CI 0.86 to 1.06, four studies, n = 1932).\nAuthors' conclusions\nZinc supplementation in children is associated with a reduction in the incidence and prevalence of pneumonia.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, evidence quality was assessed as low on GRADE assessment."
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query-laysum | 2463 | [
{
"role": "user",
"content": "Abstract: Background\nIntravenous cannulation is a painful procedure that can provoke anxiety and stress. Injecting local anaesthetic can provide analgesia at the time of cannulation, but it is a painful procedure. Topical anaesthetic creams take between 30 and 90 minutes to produce an effect. A quicker acting analgesic allows more timely investigation and treatment. Vapocoolants have been used in this setting, but studies have reported mixed results.\nObjectives\nTo determine effects of vapocoolants on pain associated with intravenous cannulation in adults and children. To explore variables that might affect the performance of vapocoolants, including time required for application, distance from the skin when applied and time to cannulation. To look at adverse effects associated with the use of vapocoolants.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Latin American Caribbean Health Sciences Literature (LILACS), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Institute for Scientific Information (ISI) Web of Science and the http://clinicaltrials.gov/, http://www.controlled-trials.com/ and http://www.trialscentral.org/ databases to 1 May 2015. We applied no language restrictions. We also scanned the reference lists of included papers.\nSelection criteria\nWe included all blinded and unblinded randomized controlled trials (RTCs) comparing any vapocoolant with placebo or control to reduce pain during intravenous cannulation in adults and children.\nData collection and analysis\nThree review authors independently assessed trial quality and extracted data, contacted study authors for additional information and assessed included studies for risk of bias. We collected and analysed data for the primary outcome of pain during cannulation, and for the secondary outcomes of pain associated with application of the vapocoolant, first attempt success rate of intravenous cannulation, adverse events and participant satisfaction. We performed subgroup analyses for the primary outcome to examine differences based on age of participant, type of vapocoolant used, application time of vapocoolant and clinical situation (emergency vs elective). We used random-effects model meta-analysis in RevMan 5.3 and assessed heterogeneity between trial results by examining forest plots and calculating the I2 statistic.\nMain results\nWe found nine suitable studies of 1070 participants and included them in the qualitative analyses. We included eight studies of 848 participants in the meta-analysis for the primary outcome (pain during intravenous cannulation). Use of vapocoolants resulted in a reduction in pain scores as measured by a linear 100 mm visual analogue scale (VAS 100) compared with controls (difference between means -12.5 mm, 95% confidence interval (CI) -18.7 to -6.4 mm; moderate-quality evidence). We could not include in the meta-analysis one study, which showed no effects of the intervention.\nUse of vapocoolants resulted in increased pain scores at the time of application as measured by a VAS 100 compared with controls (difference between means 6.3 mm, 95% CI 2.2 to 10.3 mm; four studies, 461 participants; high-quality evidence) and led to no difference in first attempt success compared with controls (risk ratio (RR) 1.00, 95% CI 0.94 to 1.06; six studies, 812 participants; moderate-quality evidence). We documented eight minor adverse events reported in 279 vapocoolant participants (risk difference (RD) 0.03, 95% CI 0 to 0.05; five studies, 551 participants; low quality-evidence).\nThe overall risk of bias of individual studies ranged from low to high, with high risk of bias for performance and detection bias in four studies. Sensitivity analysis showed that exclusion of studies at high or unclear risk of bias did not materially alter the results of this review.\nAuthors' conclusions\nModerate-quality evidence indicates that use of a vapocoolant immediately before intravenous cannulation reduces pain during the procedure. Use of vapocoolant does not increase the difficulty of cannulation nor cause serious adverse effects but is associated with mild discomfort during application.\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": "Intravenous cannulation for blood tests or treatment is a common, often painful, procedure. Vapocoolant sprays or \"cold sprays\" are delivered onto the skin just before needle insertion to provide some pain relief. Vapocoolants offer several advantages over other pain relief techniques, particularly their rapid effects (a few seconds).\nWe reviewed the evidence showing how effective vapocoolants are in reducing the pain associated with inserting an intravenous cannula. The evidence is current to May 2015."
}
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query-laysum | 2464 | [
{
"role": "user",
"content": "Abstract: Background\nA sedentary lifestyle and stress are major risk factors for cardiovascular disease (CVD). Since yoga involves exercise and is thought to help in stress reduction it may be an effective strategy in the primary prevention of CVD.\nObjectives\nTo determine the effect of any type of yoga on the primary prevention of CVD.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 11) in The Cochrane Library; MEDLINE (Ovid) (1946 to November Week 3 2013); EMBASE Classic + EMBASE (Ovid) (1947 to 2013 Week 48); Web of Science (Thomson Reuters) (1970 to 4 December 2013); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (Issue 4 of 4, 2013) in The Cochrane Library. We also searched a number of Asian databases and the Allied and Complementary Medicine Database (AMED) (inception to December 2012). We searched trial registers and reference lists of reviews and articles, and approached experts in the field. We applied no language restrictions.\nSelection criteria\nRandomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of yoga and the comparison group was no intervention or minimal intervention. Outcomes of interest were clinical CVD events and major CVD risk factors. We did not include any trials that involved multifactorial lifestyle interventions or weight loss.\nData collection and analysis\nTwo authors independently selected trials for inclusion, extracted data and assessed the risk of bias.\nMain results\nWe identified 11 trials (800 participants) and two ongoing studies. Style and duration of yoga differed between trials. Half of the participants recruited to the studies were at high risk of CVD. Most of studies were at risk of performance bias, with inadequate details reported in many of them to judge the risk of selection bias.\nNo study reported cardiovascular mortality, all-cause mortality or non-fatal events, and most studies were small and short-term. There was substantial heterogeneity between studies making it impossible to combine studies statistically for systolic blood pressure and total cholesterol. Yoga was found to produce reductions in diastolic blood pressure (mean difference (MD) -2.90 mmHg, 95% confidence interval (CI) -4.52 to -1.28), which was stable on sensitivity analysis, triglycerides (MD -0.27 mmol/l, 95% CI -0.44 to -0.11) and high-density lipoprotein (HDL) cholesterol (MD 0.08 mmol/l, 95% CI 0.02 to 0.14). However, the contributing studies were small, short-term and at unclear or high risk of bias. There was no clear evidence of a difference between groups for low-density lipoprotein (LDL) cholesterol (MD -0.09 mmol/l, 95% CI -0.48 to 0.30), although there was moderate statistical heterogeneity. Adverse events, occurrence of type 2 diabetes and costs were not reported in any of the included studies. Quality of life was measured in three trials but the results were inconclusive.\nAuthors' conclusions\nThe limited evidence comes from small, short-term, low-quality studies. There is some evidence that yoga has favourable effects on diastolic blood pressure, HDL cholesterol and triglycerides, and uncertain effects on LDL cholesterol. These results should be considered as exploratory and interpreted with caution.\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": "These results should be considered as exploratory and interpreted with caution. This is because the included studies were of short duration, small and at risk of bias (where there was a risk of arriving at the wrong conclusions because of favouritism by the participants or researchers)."
}
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query-laysum | 2465 | [
{
"role": "user",
"content": "Abstract: Background\nShift work results in sleep-wake disturbances, which cause sleepiness during night shifts and reduce sleep length and quality in daytime sleep after the night shift. In its serious form it is also called shift work sleep disorder. Various pharmacological products are used to ameliorate symptoms of sleepiness or poor sleep length and quality.\nObjectives\nTo evaluate the effects of pharmacological interventions to reduce sleepiness or to improve alertness at work and decrease sleep disturbances whilst off work, or both, in workers undertaking shift work in their present job and to assess their cost-effectiveness.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PubMed and PsycINFO up to 20 September 2013 and ClinicalTrials.gov up to July 2013. We also screened reference lists of included trials and relevant reviews.\nSelection criteria\nWe included all eligible randomised controlled trials (RCTs), including cross-over RCTs, of pharmacological products among workers who were engaged in shift work (including night shifts) in their present jobs and who may or may not have had sleep problems. Primary outcomes were sleep length and sleep quality while off work, alertness and sleepiness, or fatigue at work.\nData collection and analysis\nTwo authors independently selected studies, extracted data and assessed risk of bias in included trials. We performed meta-analyses where appropriate.\nMain results\nWe included 15 randomised placebo-controlled trials with 718 participants. Nine trials evaluated the effect of melatonin and two the effect of hypnotics for improving sleep problems. One trial assessed the effect of modafinil, two of armodafinil and one examined caffeine plus naps to decrease sleepiness or to increase alertness.\nMelatonin (1 to 10 mg) after the night shift may increase sleep length during daytime sleep (mean difference (MD) 24 minutes, 95% confidence interval (CI) 9.8 to 38.9; seven trials, 263 participants, low quality evidence) and night-time sleep (MD 17 minutes, 95% CI 3.71 to 30.22; three trials, 234 participants, low quality evidence) compared to placebo. We did not find a dose-response effect. Melatonin may lead to similar sleep latency times as placebo (MD 0.37minutes, 95% CI - 1.55 to 2.29; five trials, 74 participants, low quality evidence).\nHypnotic medication, zopiclone, did not result in significantly longer daytime sleep length compared to placebo in one low quality trial and we could not use the data from the study on lormetazepam.\nArmodafinil taken before the night shift probably reduces sleepiness by one point on the Karolinska Sleepiness Scale (KSS) (MD -0.99, 95% CI -1.32 to -0.67; range 1 to 10; two trials, 572 participants, moderate quality evidence) and increases alertness by 50 ms in a simple reaction time test (MD -50.0, 95% CI -85.5 to -15.5) at three months' follow-up in shift work sleep disorder patients. Modafinil probably has similar effects on sleepiness (KSS) (MD -0.90, 95% CI -1.45 to -0.35; one trial, 183 participants, moderate quality evidence) and alertness in the psychomotor vigilance test in the same patient group. Post-marketing, severe skin reactions have been reported. Adverse effects reported by trial participants were headache, nausea and a rise in blood pressure. There were no trials in non-patient shift workers.\nBased on one trial, caffeine plus pre-shift naps taken before the night shift decreased sleepiness (KSS) (MD -0.63, 95% CI -1.09 to -0.17).\nWe judged most trials to have a low risk of bias even though the randomisation method and allocation concealment were often not described.\nAuthors' conclusions\nThere is low quality evidence that melatonin improves sleep length after a night shift but not other sleep quality parameters. Both modafinil and armodafinil increase alertness and reduce sleepiness to some extent in employees who suffer from shift work sleep disorder but they are associated with adverse events. Caffeine plus naps reduces sleepiness during the night shift, but the quality of evidence is low. Based on one low quality trial, hypnotics did not improve sleep length and quality after a night shift.\nWe need more and better quality trials on the beneficial and adverse effects and costs of all pharmacological agents that induce sleep or promote alertness in shift workers both with and without a diagnosis of shift work sleep disorder. We also need systematic reviews of their adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Effect on alertness or sleepiness during the shift\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People that take modafinil and armodafinil probably have a small reduction in sleepiness and an increase in alertness during the night shift, based on evidence at three months' follow-up in people with shift work sleep disorder (moderate quality evidence). Headache and nausea were the most common side effects both in the short and long term follow-up. However, serious skin disorders have been reported since these drugs have come on the market. We found no trials in shift workers without a diagnosis of shift work sleep disorder.\nWe found one trial which showed that people that took caffeine before the night shift in combination with a nap before the shift had increased alertness during the night shift."
}
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query-laysum | 2466 | [
{
"role": "user",
"content": "Abstract: Background\nNausea and vomiting are distressing symptoms which are experienced commonly during caesarean section under regional anaesthesia and in the postoperative period.\nObjectives\nTo assess the efficacy of pharmacological and non-pharmacological interventions versus placebo or no intervention given prophylactically to prevent nausea and vomiting in women undergoing regional anaesthesia for caesarean section.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (16 April 2020), and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of studies and conference abstracts, and excluded quasi-RCTs and cross-over studies.\nData collection and analysis\nReview authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Our primary outcomes are intraoperative and postoperative nausea and vomiting. Data entry was checked. Two review authors independently assessed the certainty of the evidence using the GRADE approach.\nMain results\nEighty-four studies (involving 10,990 women) met our inclusion criteria. Sixty-nine studies, involving 8928 women, contributed data. Most studies involved women undergoing elective caesarean section. Many studies were small with unclear risk of bias and sometimes few events. The overall certainty of the evidence assessed using GRADE was moderate to very low.\n5-HT3 antagonists: We found intraoperative nausea may be reduced by 5-HT3 antagonists (average risk ratio (aRR) 0.55, 95% confidence interval (CI) 0.42 to 0.71, 12 studies, 1419 women, low-certainty evidence). There may be a reduction in intraoperative vomiting but the evidence is very uncertain (aRR 0.46, 95% CI 0.29 to 0.73, 11 studies, 1414 women, very low-certainty evidence). There is probably a reduction in postoperative nausea (aRR 0.40, 95% CI 0.30 to 0.54, 10 studies, 1340 women, moderate-certainty evidence), and these drugs may show a reduction in postoperative vomiting (aRR 0.47, 95% CI 0.31 to 0.69, 10 studies, 1450 women, low-certainty evidence).\nDopamine antagonists: We found dopamine antagonists may reduce intraoperative nausea but the evidence is very uncertain (aRR 0.38, 95% CI 0.27 to 0.52, 15 studies, 1180 women, very low-certainty evidence). Dopamine antagonists may reduce intraoperative vomiting (aRR 0.41, 95% CI 0.28 to 0.60, 12 studies, 942 women, low-certainty evidence) and postoperative nausea (aRR 0.61, 95% CI 0.48 to 0.79, 7 studies, 601 women, low-certainty evidence). We are uncertain if dopamine antagonists reduce postoperative vomiting (aRR 0.63, 95% CI 0.44 to 0.92, 9 studies, 860 women, very low-certainty evidence).\nCorticosteroids (steroids): We are uncertain if intraoperative nausea is reduced by corticosteroids (aRR 0.56, 95% CI 0.37 to 0.83, 6 studies, 609 women, very low-certainty evidence) similarly for intraoperative vomiting (aRR 0.52, 95% CI 0.31 to 0.87, 6 studies, 609 women, very low-certainty evidence). Corticosteroids probably reduce postoperative nausea (aRR 0.59, 95% CI 0.49 to 0.73, 6 studies, 733 women, moderate-certainty evidence), and may reduce postoperative vomiting (aRR 0.68, 95% CI 0.49 to 0.95, 7 studies, 793 women, low-certainty evidence).\nAntihistamines: Antihistamines may have little to no effect on intraoperative nausea (RR 0.99, 95% CI 0.47 to 2.11, 1 study, 149 women, very low-certainty evidence) or intraoperative vomiting (no events in the one study of 149 women). Antihistamines may reduce postoperative nausea (aRR 0.44, 95% CI 0.30 to 0.64, 4 studies, 514 women, low-certainty evidence), however, we are uncertain whether antihistamines reduce postoperative vomiting (average RR 0.48, 95% CI 0.29 to 0.81, 3 studies, 333 women, very low-certainty evidence).\nAnticholinergics: Anticholinergics may reduce intraoperative nausea (aRR 0.67, 95% CI 0.51 to 0.87, 4 studies, 453 women, low-certainty evidence) but may have little to no effect on intraoperative vomiting (aRR 0.79, 95% CI 0.40 to 1.54, 4 studies; 453 women, very low-certainty evidence). No studies looked at anticholinergics in postoperative nausea, but they may reduce postoperative vomiting (aRR 0.55, 95% CI 0.41 to 0.74, 1 study, 161 women, low-certainty evidence).\nSedatives: We found that sedatives probably reduce intraoperative nausea (aRR 0.65, 95% CI 0.51 to 0.82, 8 studies, 593 women, moderate-certainty evidence) and intraoperative vomiting (aRR 0.35, 95% CI 0.24 to 0.52, 8 studies, 593 women, moderate-certainty evidence). However, we are uncertain whether sedatives reduce postoperative nausea (aRR 0.25, 95% CI 0.09 to 0.71, 2 studies, 145 women, very low-certainty evidence) and they may reduce postoperative vomiting (aRR 0.09, 95% CI 0.03 to 0.28, 2 studies, 145 women, low-certainty evidence).\nOpioid antagonists: There were no studies assessing intraoperative nausea or vomiting. Opioid antagonists may result in little or no difference to the number of women having postoperative nausea (aRR 0.75, 95% CI 0.39 to 1.45, 1 study, 120 women, low-certainty evidence) or postoperative vomiting (aRR 1.25, 95% CI 0.35 to 4.43, 1 study, 120 women, low-certainty evidence).\nAcupressure: It is uncertain whether acupressure/acupuncture reduces intraoperative nausea (aRR 0.55, 95% CI 0.41 to 0.74, 9 studies, 1221 women, very low-certainty evidence). Acupressure may reduce intraoperative vomiting (aRR 0.52, 95% CI 0.33 to 0.80, 9 studies, 1221 women, low-certainty evidence) but it is uncertain whether it reduces postoperative nausea (aRR 0.46, 95% CI 0.27 to 0.75, 7 studies, 1069 women, very low-certainty evidence) or postoperative vomiting (aRR 0.52, 95% CI 0.34 to 0.79, 7 studies, 1069 women, very low-certainty evidence).\nGinger: It is uncertain whether ginger makes any difference to the number of women having intraoperative nausea (aRR 0.66, 95% CI 0.36 to 1.21, 2 studies, 331 women, very low-certainty evidence), intraoperative vomiting (aRR 0.62, 95% CI 0.38 to 1.00, 2 studies, 331 women, very low-certainty evidence), postoperative nausea (aRR 0.63, 95% CI 0.22 to 1.77, 1 study, 92 women, very low-certainty evidence) and postoperative vomiting (aRR 0.20, 95% CI 0.02 to 1.65, 1 study, 92 women, very low-certainty evidence).\nFew studies assessed our secondary outcomes including adverse effects or women's views.\nAuthors' conclusions\nThis review indicates that 5-HT3 antagonists, dopamine antagonists, corticosteroids, sedatives and acupressure probably or possibly have efficacy in reducing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. However the certainty of evidence varied widely and was generally low. Future research is needed to assess side effects of treatment, women's views and to compare the efficacy of combinations of different medications.\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": "Several classes of drugs may help to reduce the number of women who experience nausea and vomiting during and after regional anaesthesia for caesarean births, although more data are needed. Acupressure may also help but we did not find enough data on ginger. Very few studies looked at women’s views and overall, there were not enough data on possible side effects."
}
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query-laysum | 2467 | [
{
"role": "user",
"content": "Abstract: Background\nThe workplace has potential as a setting through which large groups of people can be reached to encourage smoking cessation.\nObjectives\n1. To categorize workplace interventions for smoking cessation tested in controlled studies and to determine the extent to which they help workers to stop smoking.\n2. To collect and evaluate data on costs and cost effectiveness associated with workplace interventions.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register (July 2013), MEDLINE (1966 - July 2013), EMBASE (1985 - June 2013), and PsycINFO (to June 2013), amongst others. We searched abstracts from international conferences on tobacco and the bibliographies of identified studies and reviews for additional references.\nSelection criteria\nWe selected interventions conducted in the workplace to promote smoking cessation. We included only randomized and quasi-randomized controlled trials allocating individuals, workplaces, or companies to intervention or control conditions.\nData collection and analysis\nOne author extracted information relating to the characteristics and content of all kinds of interventions, participants, outcomes and methods of the studies, and a second author checked them. For this update we have conducted meta-analyses of the main interventions, using the generic inverse variance method to generate odds ratios and 95% confidence intervals.\nMain results\nWe include 57 studies (61 comparisons) in this updated review. We found 31 studies of workplace interventions aimed at individual workers, covering group therapy, individual counselling, self-help materials, nicotine replacement therapy, and social support, and 30 studies testing interventions applied to the workplace as a whole, i.e. environmental cues, incentives, and comprehensive programmes. The trials were generally of moderate to high quality, with results that were consistent with those found in other settings. Group therapy programmes (odds ratio (OR) for cessation 1.71, 95% confidence interval (CI) 1.05 to 2.80; eight trials, 1309 participants), individual counselling (OR 1.96, 95% CI 1.51 to 2.54; eight trials, 3516 participants), pharmacotherapies (OR 1.98, 95% CI 1.26 to 3.11; five trials, 1092 participants), and multiple intervention programmes aimed mainly or solely at smoking cessation (OR 1.55, 95% CI 1.13 to 2.13; six trials, 5018 participants) all increased cessation rates in comparison to no treatment or minimal intervention controls. Self-help materials were less effective (OR 1.16, 95% CI 0.74 to 1.82; six trials, 1906 participants), and two relapse prevention programmes (484 participants) did not help to sustain long-term abstinence. Incentives did not appear to improve the odds of quitting, apart from one study which found a sustained positive benefit. There was a lack of evidence that comprehensive programmes targeting multiple risk factors reduced the prevalence of smoking.\nAuthors' conclusions\n1. We found strong evidence that some interventions directed towards individual smokers increase the likelihood of quitting smoking. These include individual and group counselling, pharmacological treatment to overcome nicotine addiction, and multiple interventions targeting smoking cessation as the primary or only outcome. All these interventions show similar effects whether offered in the workplace or elsewhere. Self-help interventions and social support are less effective. Although people taking up these interventions are more likely to stop, the absolute numbers who quit are low.\n2. We failed to detect an effect of comprehensive programmes targeting multiple risk factors in reducing the prevalence of smoking, although this finding was not based on meta-analysed data.\n\n3. There was limited evidence that participation in programmes can be increased by competitions and incentives organized by the employer, although one trial demonstrated a sustained effect of financial rewards for attending a smoking cessation course and for long-term quitting. Further research is needed to establish which components of this trial contributed to the improvement in success rates.\n4. Further research would be valuable in low-income and developing countries, where high rates of smoking prevail and smoke-free legislation is not widely accepted or enforced.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The workplace appears to be a useful setting for helping people to stop smoking. Large groups of smokers are available who can easily be reached and helped, using proven methods. It is also in the employers’ interests to improve the health of their workforce. Recent changes introducing anti-smoking laws in many developed countries may have eased the pressure to demonstrate the value of work-based programmes. The situation in developing countries still requires that such methods be tested and proved in those communities. We reviewed the evidence about workplace programmes to help employees stop smoking, and any information about their costs and benefits."
}
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query-laysum | 2468 | [
{
"role": "user",
"content": "Abstract: Background\nFundal pressure during the second stage of labour (also known as the 'Kristeller manoeuvre') involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal, in an attempt to assist spontaneous vaginal birth and avoid prolonged second stage or the need for operative birth. Fundal pressure has also been applied using an inflatable belt. Fundal pressure is widely used, however methods of its use vary widely. Despite strongly held opinions in favour of and against the use of fundal pressure, there is limited evidence regarding its maternal and neonatal benefits and harms. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour.\nObjectives\nTo determine if fundal pressure is effective in achieving spontaneous vaginal birth, and preventing prolonged second stage or the need for operative birth, and to explore maternal and neonatal adverse effects related to fundal pressure.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials of fundal pressure (manual or by inflatable belt) versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation.\nData collection and analysis\nTwo or more review authors independently assessed potential studies for inclusion and quality. We extracted data using a pre-designed form. We entered data into Review Manager 5 software and checked for accuracy.\nMain results\nNine trials are included in this updated review. Five trials (3057 women) compared manual fundal pressure versus no fundal pressure. Four trials (891 women) compared fundal pressure by means of an inflatable belt versus no fundal pressure. It was not possible to blind women and staff to this intervention. We assessed two trials as being at high risk of attrition bias and another at high risk of reporting bias. All other trials were low or unclear for other risk of bias domains. Most of the trials had design limitations. Heterogeneity was high for the majority of outcomes.\nManual fundal pressure versus no fundal pressure\nManual fundal pressure was not associated with changes in: spontaneous vaginal birth within a specified time (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.71 to 1.28; 120 women; 1 trial; very low-quality evidence), instrumental births (RR 3.28, 95% CI 0.14 to 79.65; 197 women; 1 trial), caesarean births (RR 1.10, 95% CI 0.07 to 17.27; 197 women; 1 trial), operative birth (average RR 0.66, 95% CI 0.12 to 3.55; 317 women; 2 studies; I² = 43%; Tau² = 0.71; very low-quality evidence), duration of second stage (mean difference (MD) -0.80 minutes, 95% CI -3.66 to 2.06 minutes; 194 women; 1 study; very low-quality evidence), low arterial cord pH in newborn babies (RR 1.07, 95% CI 0.72 to 1.58; 297 women; 2 trials; very low-quality evidence), or Apgar scores less than seven at five minutes (average RR 4.48, 95% CI 0.28 to 71.45; 2759 infants; 4 trials; I² = 89%; Tau² = 3.55; very low-quality evidence). More women who received manual fundal pressure had cervical tears than in the control group (RR 4.90, 95% CI 1.09 to 21.98; 295 women; 1 trial). No neonatal deaths occurred in either of the two studies reporting this outcome (very low-quality evidence). No trial reported the outcome severe maternal morbidity or death.\nFundal pressure by inflatable belt versus no fundal pressure\nFundal pressure by inflatable belt did not reduce the number of women havinginstrumental births (average RR 0.73, 95% CI 0.52 to 1.02; 891 women; 4 trials; I² = 52%; Tau² = 0.05) or operative births (average RR 0.62, 95% CI 0.38 to 1.01; 891 women; 4 trials; I² = 78%; Tau² = 0.14; very low-quality evidence). Heterogeneity was high for both outcomes. Duration of second stage was reported in two trials, which both showed that inflatable belts shortened duration of labour in nulliparous women (average MD -50.80 minutes, 95% CI -94.85 to -6.74 minutes; 253 women; 2 trials; I² = 97%; Tau² = 975.94; very low-quality evidence). No data on this outcome were available for multiparous women. The inflatable belt did not make any difference to rates of caesarean births (average RR 0.56, 95% CI 0.14 to 2.26; 891 women; 4 trials; I² = 70%; Tau² = 0.98), low arterial cord pH in newborn babies (RR 0.47, 95% CI 0.09 to 2.55; 461 infants; 1 trial; low-quality evidence), or Apgar scores less than seven at five minutes (RR 4.62, 95% CI 0.22 to 95.68; 500 infants; 1 trial; very low-quality evidence). Third degree perineal tears were increased in the inflatable belt group (RR 15.69, 95% CI 2.10 to 117.02; 500 women; 1 trial). Spontaneous vaginal birth within a specified time, neonatal death, andsevere maternal morbidity or death were not reported in any trial.\nAuthors' conclusions\nThere is insufficient evidence to draw conclusions on the beneficial or harmful effects of fundal pressure, either manually or by inflatable belt. Fundal pressure by an inflatable belt during the second stage of labour may shorten duration of second stage for nulliparous women, and lower rates of operative birth. However, existing studies are small and their generalizability is uncertain. There is insufficient evidence regarding safety for the baby. There is no evidence on the use of fundal pressure in specific clinical settings such as inability of the mother to bear down due to exhaustion or unconsciousness. There is currently insufficient evidence for the routine use of fundal pressure by any method on women in the second stage of labour. Because of current widespread use of the procedure and the potential for use in settings where other methods of assisted birth are not available, further good quality trials are needed. Further evaluation in other groups of women (such as multiparous women) will also be required. Future research should describe in detail how fundal pressure was applied and consider safety of the unborn baby, perineal outcomes, longer-term maternal and infant outcomes 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": "A long labour can sometimes be dangerous for some women and their babies. Sometimes the unborn baby and woman can become exhausted during the labour and birth. In many countries, there are trained professionals who can assist with ventouse, forceps or caesarean sections. However in other countries, these resources are often lacking, and long labours can be life-threatening. Fundal pressure may help the woman to give birth. It may also possibly increase complications for the baby and mother. There is not a lot of knowledge on this topic, and it is important to know how these techniques might affect the women and their babies."
}
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query-laysum | 2469 | [
{
"role": "user",
"content": "Abstract: Background\nLung cancer is the most commonly diagnosed cancer and the leading cause of cancer death in both sexes worldwide. Approximately 50% of those diagnosed with lung cancer will have locally advanced or metastatic disease and will be treated in a palliative setting. Platinum-based combination chemotherapy has benefits in terms of survival and symptom control when compared with best supportive care.\nObjectives\nTo assess the effectiveness and safety of carboplatin-based chemotherapy when compared with cisplatin-based chemotherapy, both in combination with a third-generation drug, in people with advanced non-small cell lung cancer (NSCLC). To compare quality of life in people with advanced NSCLC receiving chemotherapy with cisplatin and carboplatin combined with a third-generation drug.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 13 January 2019), MEDLINE (via PubMed) (1966 to 13 January 2019), and Embase (via Ovid) (1974 to 13 January 2019). In addition, we handsearched the proceedings of the American Society of Clinical Oncology Meetings (January 1990 to September 2018) and reference lists from relevant resources.\nSelection criteria\nRandomised clinical trials (RCTs) comparing regimens with carboplatin or cisplatin combined with a third-generation drug in people with locally advanced or metastatic NSCLC. We accepted any regimen and number of cycles that included these drugs, since there is no widely accepted standard regimen.\nData collection and analysis\nTwo review authors independently assessed the search results, and a third review author resolved any disagreements. The primary outcomes were overall survival and health-related quality of life. The secondary outcomes were one-year survival rate, objective response rate and toxicity.\nMain results\nIn this updated review, we located one additional RCT, for a total of 11 included RCTs (5088 participants, 4046 of whom were available for meta-analysis). There was no difference in overall survival (hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.82 to 1.20; 10 RCTs; 2515 participants; high-quality evidence); one-year survival rate (risk ratio (RR) 0.98, 95% CI 0.89 to 1.08; I2 = 17%; 4004 participants; all 11 RCTs; high-quality evidence); or response rate (RR 0.89, 95% CI 0.79 to 1.00; I2 = 12%; all 11 RCTs; 4020 participants; high-quality evidence). A subgroup analysis comparing carboplatin with different doses of cisplatin found an overall survival benefit in favour of carboplatin-based regimens when compared to cisplatin at lower doses (40 to 80 mg/m2) (HR 1.15, 95% CI 1.03 to 1.28; 6 RCTs; 2508 participants), although there was no overall survival benefit when carboplatin-based chemotherapy was compared to cisplatin at higher doses (80 to 100 mg/m2) (HR 0.93, 95% CI 0.83 to 1.04; I2 = 0%; 4 RCTs; 1823 participants). Carboplatin caused more thrombocytopenia (RR 2.46, 95% CI 1.49 to 4.04; I2 = 68%; 10 RCTs; 3670 participants) and was associated with more neurotoxicity (RR 1.42, 95% CI 0.91 to 2.23; I2 = 0%, 5 RCTs; 1489 participants), although we believe this last finding is probably related to a confounding factor (higher dose of paclitaxel in the carboplatin-containing treatment arm of a large study included in the analysis). There was no statistically significant difference in renal toxicity (RR 0.52, 95% CI 0.19 to 1.45; I2 = 3%; 3 RCTs; 1272 participants); alopecia (RR 1.11, 95% CI 0.73 to 1.68; I2 = 0%; 2 RCTs; 300 participants); anaemia (RR 1.37, 95% CI 0.79 to 2.38; I2 = 77%; 10 RCTs; 3857 participants); and neutropenia (RR 1.18, 95% CI 0.85 to 1.63; I2 = 94%; 10 RCTs; 3857 participants) between cisplatin-based chemotherapy and carboplatin-based chemotherapy regimens. Two RCTs performed a health-related quality of life analysis; however, as they used different methods of measurement we were unable to perform a meta-analysis. One RCT reported comparative health-related quality of life data between cisplatin and carboplatin-containing arms but found no significant differences in global indices of quality of life, including global health status or functional scales.\nIn this Cochrane review, we found that the quality of evidence was high for overall survival, one-year survival rate and response rate but moderate quality evidence for the other outcomes measured.\nAuthors' conclusions\nAdvanced NSCL patients treated with carboplatin or cisplatin doublet with third-generation chemotherapy drugs showed equivalent overall survival, one-year survival, and response rate. Regarding adverse events, carboplatin caused more thrombocytopenia, and cisplatin caused more nausea/vomiting. Therefore, in this palliative therapeutic intent, the choice of the platin compound should take into account the expected toxicity profile, patient's comorbidities and preferences.\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": "Lung cancer is the leading cause of cancer death, and more than a half of people found to have the cancer have incurable disease at diagnosis. Non-small cell is the most common type of lung cancer, corresponding to approximately 85% of all lung cancer cases. Despite recent advances in targeted therapies and immunotherapy, platinum-based chemotherapy remains a useful and accessible option with well-established survival benefits for people with advanced non-small cell lung cancer. Although treatment regimens including cisplatin or carboplatin plus another agent are widely used, they can be associated with undesirable side effects. The aim of this systematic review was to determine which of these two frequently used drugs was more effective and caused fewer side effects."
}
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query-laysum | 2470 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease (CVD) is a leading cause of death globally. Recently, dipeptidyl peptidase-4 inhibitors (DPP4i), glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter-2 inhibitors (SGLT2i) were approved for treating people with type 2 diabetes mellitus. Although metformin remains the first-line pharmacotherapy for people with type 2 diabetes mellitus, a body of evidence has recently emerged indicating that DPP4i, GLP-1RA and SGLT2i may exert positive effects on patients with known CVD.\nObjectives\nTo systematically review the available evidence on the benefits and harms of DPP4i, GLP-1RA, and SGLT2i in people with established CVD, using network meta-analysis.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and the Conference Proceedings Citation Index on 16 July 2020. We also searched clinical trials registers on 22 August 2020. We did not restrict by language or publication status.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) investigating DPP4i, GLP-1RA, or SGLT2i that included participants with established CVD. Outcome measures of interest were CVD mortality, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, all-cause mortality, hospitalisation for heart failure (HF), and safety outcomes.\nData collection and analysis\nThree review authors independently screened the results of searches to identify eligible studies and extracted study data. We used the GRADE approach to assess the certainty of the evidence. We conducted standard pairwise meta-analyses and network meta-analyses by pooling studies that we assessed to be of substantial homogeneity; subgroup and sensitivity analyses were also pursued to explore how study characteristics and potential effect modifiers could affect the robustness of our review findings. We analysed study data using the odds ratios (ORs) and log odds ratios (LORs) with their respective 95% confidence intervals (CIs) and credible intervals (Crls), where appropriate. We also performed narrative synthesis for included studies that were of substantial heterogeneity and that did not report quantitative data in a usable format, in order to discuss their individual findings and relevance to our review scope.\nMain results\nWe included 31 studies (287 records), of which we pooled data from 20 studies (129,465 participants) for our meta-analysis. The majority of the included studies were at low risk of bias, using Cochrane's tool for assessing risk of bias. Among the 20 pooled studies, six investigated DPP4i, seven studied GLP-1RA, and the remaining seven trials evaluated SGLT2i. All outcome data described below were reported at the longest follow-up duration.\n1. DPP4i versus placebo\nOur review suggests that DPP4i do not reduce any risk of efficacy outcomes: CVD mortality (OR 1.00, 95% CI 0.91 to 1.09; high-certainty evidence), myocardial infarction (OR 0.97, 95% CI 0.88 to 1.08; high-certainty evidence), stroke (OR 1.00, 95% CI 0.87 to 1.14; high-certainty evidence), and all-cause mortality (OR 1.03, 95% CI 0.96 to 1.11; high-certainty evidence). DPP4i probably do not reduce hospitalisation for HF (OR 0.99, 95% CI 0.80 to 1.23; moderate-certainty evidence). DPP4i may not increase the likelihood of worsening renal function (OR 1.08, 95% CI 0.88 to 1.33; low-certainty evidence) and probably do not increase the risk of bone fracture (OR 1.00, 95% CI 0.83 to 1.19; moderate-certainty evidence) or hypoglycaemia (OR 1.11, 95% CI 0.95 to 1.29; moderate-certainty evidence). They are likely to increase the risk of pancreatitis (OR 1.63, 95% CI 1.12 to 2.37; moderate-certainty evidence).\n2. GLP-1RA versus placebo\nOur findings indicate that GLP-1RA reduce the risk of CV mortality (OR 0.87, 95% CI 0.79 to 0.95; high-certainty evidence), all-cause mortality (OR 0.88, 95% CI 0.82 to 0.95; high-certainty evidence), and stroke (OR 0.87, 95% CI 0.77 to 0.98; high-certainty evidence). GLP-1RA probably do not reduce the risk of myocardial infarction (OR 0.89, 95% CI 0.78 to 1.01; moderate-certainty evidence), and hospitalisation for HF (OR 0.95, 95% CI 0.85 to 1.06; high-certainty evidence). GLP-1RA may reduce the risk of worsening renal function (OR 0.61, 95% CI 0.44 to 0.84; low-certainty evidence), but may have no impact on pancreatitis (OR 0.96, 95% CI 0.68 to 1.35; low-certainty evidence). We are uncertain about the effect of GLP-1RA on hypoglycaemia and bone fractures.\n3. SGLT2i versus placebo\nThis review shows that SGLT2i probably reduce the risk of CV mortality (OR 0.82, 95% CI 0.70 to 0.95; moderate-certainty evidence), all-cause mortality (OR 0.84, 95% CI 0.74 to 0.96; moderate-certainty evidence), and reduce the risk of HF hospitalisation (OR 0.65, 95% CI 0.59 to 0.71; high-certainty evidence); they do not reduce the risk of myocardial infarction (OR 0.97, 95% CI 0.84 to 1.12; high-certainty evidence) and probably do not reduce the risk of stroke (OR 1.12, 95% CI 0.92 to 1.36; moderate-certainty evidence). In terms of treatment safety, SGLT2i probably reduce the incidence of worsening renal function (OR 0.59, 95% CI 0.43 to 0.82; moderate-certainty evidence), and probably have no effect on hypoglycaemia (OR 0.90, 95% CI 0.75 to 1.07; moderate-certainty evidence) or bone fracture (OR 1.02, 95% CI 0.88 to 1.18; high-certainty evidence), and may have no impact on pancreatitis (OR 0.85, 95% CI 0.39 to 1.86; low-certainty evidence).\n4. Network meta-analysis\nBecause we failed to identify direct comparisons between each class of the agents, findings from our network meta-analysis provided limited novel insights. Almost all findings from our network meta-analysis agree with those from the standard meta-analysis. GLP-1RA may not reduce the risk of stroke compared with placebo (OR 0.87, 95% CrI 0.75 to 1.0; moderate-certainty evidence), which showed similar odds estimates and wider 95% Crl compared with standard pairwise meta-analysis. Indirect estimates also supported comparison across all three classes. SGLT2i was ranked the best for CVD and all-cause mortality.\nAuthors' conclusions\nFindings from both standard and network meta-analyses of moderate- to high-certainty evidence suggest that GLP-1RA and SGLT2i are likely to reduce the risk of CVD mortality and all-cause mortality in people with established CVD; high-certainty evidence demonstrates that treatment with SGLT2i reduce the risk of hospitalisation for HF, while moderate-certainty evidence likely supports the use of GLP-1RA to reduce fatal and non-fatal stroke. Future studies conducted in the non-diabetic CVD population will reveal the mechanisms behind how these agents improve clinical outcomes irrespective of their glucose-lowering effects.\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": "- GLP-1RA and SGLT2i (two new diabetes medicines) are likely to reduce the risk of death from cardiovascular disease and death from any cause in people with both diabetes and established cardiovascular disease (diseases of the heart and blood vessels).\n- SGLT2i medicines are likely to reduce the risk of hospitalisation for heart failure and GLP-1RA medicines may reduce fatal and non-fatal stroke.\n- We need further studies to find out if these medicines also have a positive effect on cardiovascular health in people without diabetes or if the effects seen in people with diabetes are due only to these medicines’ ability to control blood sugar."
}
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query-laysum | 2471 | [
{
"role": "user",
"content": "Abstract: Background\nEpidermal growth factor receptor (EGFR) mutation positive (M+) non-small cell lung cancer (NSCLC) is an important subtype of lung cancer comprising 10% to 15% of non-squamous tumours. This subtype is more common in women than men, is less associated with smoking, but occurs at a younger age than sporadic tumours.\nObjectives\nTo assess the clinical effectiveness of single-agent or combination EGFR therapies used in the first-line treatment of people with locally advanced or metastatic EGFR M+ NSCLC compared with other cytotoxic chemotherapy (CTX) agents used alone or in combination, or best supportive care (BSC). The primary outcomes were overall survival and progression-free survival. Secondary outcomes included response rate, symptom palliation, toxicity, and health-related quality of life.\nSearch methods\nWe conducted electronic searches of the Cochrane Register of Controlled Trials (CENTRAL) (2020, Issue 7), MEDLINE (1946 to 27th July 2020), Embase (1980 to 27th July 2020), and ISI Web of Science (1899 to 27th July 2020). We also searched the conference abstracts of the American Society for Clinical Oncology and the European Society for Medical Oncology (July 2020); Evidence Review Group submissions to the National Institute for Health and Care Excellence; and the reference lists of retrieved articles.\nSelection criteria\nParallel-group randomised controlled trials comparing EGFR-targeted agents (alone or in combination with cytotoxic agents or BSC) with cytotoxic chemotherapy (single or doublet) or BSC in chemotherapy-naive patients with locally advanced or metastatic (stage IIIB or IV) EGFR M+ NSCLC unsuitable for treatment with curative intent.\nData collection and analysis\nTwo review authors independently identified articles, extracted data, and carried out the 'Risk of bias' assessment. We conducted meta-analyses using a fixed-effect model unless there was substantial heterogeneity, in which case we also performed a random-effects analysis as a sensitivity analysis.\nMain results\nTwenty-two trials met the inclusion criteria. Ten of these exclusively recruited people with EGFR M+ NSCLC; the remainder recruited a mixed population and reported results for people with EGFR M+ NSCLC as subgroup analyses. The number of participants with EGFR M+ tumours totalled 3023, of whom approximately 2563 were of Asian origin.\nOverall survival (OS) data showed inconsistent results between the included trials that compared EGFR-targeted treatments against cytotoxic chemotherapy or placebo.\nErlotinib was used in eight trials, gefitinib in nine trials, afatinib in two trials, cetuximab in two trials, and icotinib in one trial. The findings of FASTACT 2 suggested a clinical benefit for OS for participants treated with erlotinib plus cytotoxic chemotherapy when compared to cytotoxic chemotherapy alone, as did the Han 2017 trial for gefitinib plus cytotoxic chemotherapy, but both results were based on a small number of participants (n = 97 and 122, respectively).\nFor progression-free survival (PFS), a pooled analysis of four trials showed evidence of clinical benefit for erlotinib compared with cytotoxic chemotherapy (hazard ratio (HR) 0.31; 95% confidence interval (CI) 0.25 to 0.39 ; 583 participants ; high-certainty evidence). A pooled analysis of two trials of gefitinib versus paclitaxel plus carboplatin showed evidence of clinical benefit for PFS for gefitinib (HR 0.39; 95% CI 0.32 to 0.48 ; 491 participants high-certainty evidence), and a pooled analysis of two trials of gefitinib versus pemetrexed plus carboplatin with pemetrexed maintenance also showed evidence of clinical benefit for PFS for gefitinib (HR 0.59; 95% CI 0.46 to 0.74, 371 participants ; moderate-certainty evidence). Afatinib showed evidence of clinical benefit for PFS when compared with chemotherapy in a pooled analysis of two trials (HR 0.42; 95% CI 0.34 to 0.53, 709 participants high-certainty evidence). All but one small trial showed a corresponding improvement in response rate with tyrosine-kinase inhibitor (TKI) compared to chemotherapy.\nCommonly reported grade 3/4 adverse events associated with afatinib, erlotinib, gefitinib and icotinib monotherapy were rash and diarrhoea. Myelosuppression was consistently worse in the chemotherapy arms; fatigue and anorexia were also associated with some chemotherapies.\nSeven trials reported on health-related quality of life and symptom improvement using different methodologies. For each of erlotinib, gefitinib, and afatinib, two trials showed improvement in one or more indices for the TKI compared to chemotherapy.\nThe quality of evidence was high for the comparisons of erlotinib and gefitinib with cytotoxic chemotherapy and for the comparison of afatinib with cytotoxic chemotherapy.\nAuthors' conclusions\nErlotinib, gefitinib, afatinib and icotinib are all active agents in EGFR M+ NSCLC patients, and demonstrate an increased tumour response rate and prolonged PFS compared to cytotoxic chemotherapy. We found a beneficial effect of the TKI compared to cytotoxic chemotherapy in adverse effect and health-related quality of life. We found limited evidence for increased OS for the TKI when compared with standard chemotherapy, but the majority of the included trials allowed participants to switch treatments on disease progression, which will have a confounding effect on any OS analysis. Single agent-TKI remains the standard of care and the benefit of combining a TKI and chemotherapy remains uncertain as the evidence is based on small patient numbers. Cytotoxic chemotherapy is less effective in EGFR M+ NSCLC than erlotinib, gefitinib, afatinib or icotinib and is associated with greater toxicity. There are no data supporting the use of monoclonal antibody therapy. Icotinib is not available outside China.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The purpose of this review was to find out whether people given treatments targeted at EGFR M+ NSCLC live longer and have a better health-related quality of life than people having standard chemotherapy."
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query-laysum | 2472 | [
{
"role": "user",
"content": "Abstract: Background\nCentral venous catheter (CVC) placement increases the risk of thrombosis in people with cancer. Thrombosis often necessitates the removal of the CVC, resulting in treatment delays and thrombosis-related morbidity and mortality. This is an update of the Cochrane Review published in 2014.\nObjectives\nTo evaluate the efficacy and safety of anticoagulation for thromboprophylaxis in people with cancer with a CVC.\nSearch methods\nWe conducted a comprehensive literature search in May 2018 that included a major electronic search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), and Embase (Ovid); handsearching of conference proceedings; checking of references of included studies; searching for ongoing studies; and using the 'related citation' feature in PubMed. This update of the systematic review was based on the findings of a literature search conducted on 14 May 2018.\nSelection criteria\nRandomized controlled trials (RCTs) assessing the benefits and harms of unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), vitamin K antagonists (VKA), or fondaparinux or comparing the effects of two of these anticoagulants in people with cancer and a CVC.\nData collection and analysis\nUsing a standardized form, we extracted data and assessed risk of bias. Outcomes included all-cause mortality, symptomatic catheter-related venous thromboembolism (VTE), pulmonary embolism (PE), major bleeding, minor bleeding, catheter-related infection, thrombocytopenia, and health-related quality of life (HRQoL). We assessed the certainty of evidence for each outcome using the GRADE approach (Balshem 2011).\nMain results\nThirteen RCTs (23 papers) fulfilled the inclusion criteria. These trials enrolled 3420 participants. Seven RCTs compared LMWH to no LMWH (six in adults and one in children), six RCTs compared VKA to no VKA (five in adults and one in children), and three RCTs compared LMWH to VKA in adults.\nLMWH versus no LMWH\nSix RCTs (1537 participants) compared LMWH to no LMWH in adults. The meta-analyses showed that LMWH probably decreased the incidence of symptomatic catheter-related VTE up to three months of follow-up compared to no LMWH (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.22 to 0.81; risk difference (RD) 38 fewer per 1000, 95% CI 13 fewer to 52 fewer; moderate-certainty evidence). However, the analysis did not confirm or exclude a beneficial or detrimental effect of LMWH on mortality at three months of follow-up (RR 0.82, 95% CI 0.53 to 1.26; RD 14 fewer per 1000, 95% CI 36 fewer to 20 more; low-certainty evidence), major bleeding (RR 1.49, 95% CI 0.06 to 36.28; RD 0 more per 1000, 95% CI 1 fewer to 35 more; very low-certainty evidence), minor bleeding (RR 1.35, 95% CI 0.62 to 2.92; RD 14 more per 1000, 95% CI 16 fewer to 79 more; low-certainty evidence), and thrombocytopenia (RR 1.03, 95% CI 0.80 to 1.33; RD 5 more per 1000, 95% CI 35 fewer to 58 more; low-certainty evidence).\nVKA versus no VKA\nFive RCTs (1599 participants) compared low-dose VKA to no VKA in adults. The meta-analyses did not confirm or exclude a beneficial or detrimental effect of low-dose VKA compared to no VKA on mortality (RR 0.99, 95% CI 0.64 to 1.55; RD 1 fewer per 1000, 95% CI 34 fewer to 52 more; low-certainty evidence), symptomatic catheter-related VTE (RR 0.61, 95% CI 0.23 to 1.64; RD 31 fewer per 1000, 95% CI 62 fewer to 51 more; low-certainty evidence), major bleeding (RR 7.14, 95% CI 0.88 to 57.78; RD 12 more per 1000, 95% CI 0 fewer to 110 more; low-certainty evidence), minor bleeding (RR 0.69, 95% CI 0.38 to 1.26; RD 15 fewer per 1000, 95% CI 30 fewer to 13 more; low-certainty evidence), premature catheter removal (RR 0.82, 95% CI 0.30 to 2.24; RD 29 fewer per 1000, 95% CI 114 fewer to 202 more; low-certainty evidence), and catheter-related infection (RR 1.17, 95% CI 0.74 to 1.85; RD 71 more per 1000, 95% CI 109 fewer to 356; low-certainty evidence).\nLMWH versus VKA\nThree RCTs (641 participants) compared LMWH to VKA in adults. The available evidence did not confirm or exclude a beneficial or detrimental effect of LMWH relative to VKA on mortality (RR 0.94, 95% CI 0.56 to 1.59; RD 6 fewer per 1000, 95% CI 41 fewer to 56 more; low-certainty evidence), symptomatic catheter-related VTE (RR 1.83, 95% CI 0.44 to 7.61; RD 15 more per 1000, 95% CI 10 fewer to 122 more; very low-certainty evidence), PE (RR 1.70, 95% CI 0.74 to 3.92; RD 35 more per 1000, 95% CI 13 fewer to 144 more; low-certainty evidence), major bleeding (RR 3.11, 95% CI 0.13 to 73.11; RD 2 more per 1000, 95% CI 1 fewer to 72 more; very low-certainty evidence), or minor bleeding (RR 0.95, 95% CI 0.20 to 4.61; RD 1 fewer per 1000, 95% CI 21 fewer to 95 more; very low-certainty evidence). The meta-analyses showed that LMWH probably increased the risk of thrombocytopenia compared to VKA at three months of follow-up (RR 1.69, 95% CI 1.20 to 2.39; RD 149 more per 1000, 95% CI 43 fewer to 300 more; moderate-certainty evidence).\nAuthors' conclusions\nThe evidence was not conclusive for the effect of LMWH on mortality, the effect of VKA on mortality and catheter-related VTE, and the effect of LMWH compared to VKA on mortality and catheter-related VTE. We found moderate-certainty evidence that LMWH reduces catheter-related VTE compared to no LMWH. People with cancer with CVCs considering anticoagulation should balance the possible benefit of reduced thromboembolic complications with the possible harms and burden of anticoagulants.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A central venous catheter (CVC) is a tube that is inserted into a large vein to give fluids or medicines. CVC placement increases the risk of blood clots in people with cancer. This review evaluated the effectiveness and safety of blood thinning agents (anticoagulants) in people with cancer and a CVC."
}
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query-laysum | 2473 | [
{
"role": "user",
"content": "Abstract: Background\nNon-nutritive sucking (NNS) is used during gavage feeding and in the transition from gavage to breast/bottle feeding in preterm infants to improve the development of sucking behavior and the digestion of enteral feedings.\nObjectives\nTo assess the effects of non-nutritive sucking on physiologic stability and nutrition in preterm infants.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), MEDLINE via PubMed (1966 to 25 February 2016), Embase (1980 to 25 February 2016), and CINAHL (1982 to 25 February 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials.\nSelection criteria\nRandomised controlled trials and quasi-randomised trials that compared non-nutritive sucking versus no provision of non-nutritive sucking in preterm infants. We excluded cross-over trials.\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and undertook data extraction independently. We analysed the treatment effects in the individual trials and reported mean differences (MD) for continuous data, with 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses. We did not perform subgroup analyses because of the small number of studies related to the relevant outcomes. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe identified 12 eligible trials enrolling a total of 746 preterm infants. Meta-analysis, though limited by data quality, demonstrated a significant effect of NNS on transition from gavage to full oral feeding (MD −5.51 days, 95% CI −8.20 to −2.82; N = 87), transition from start of oral feeding to full oral feeding (MD −2.15 days, 95% CI −3.12 to −1.17; N = 100), and the length of hospital stay (MD −4.59 days, 95% CI −8.07 to −1.11; N = 501). Meta-analysis revealed no significant effect of NNS on weight gain. One study found that the NNS group had a significantly shorter intestinal transit time during gavage feeding compared to the control group (MD −10.50 h, 95% CI −13.74 to −7.26; N = 30). Other individual studies demonstrated no clear positive effect of NNS on age of infant at full oral feeds, days from birth to full breastfeeding, rates and proportion of infants fully breastfeeding at discharge, episodes of bradycardia, or episodes of oxygen desaturation. None of the studies reported any negative outcomes. These trials were generally small and contained various methodological weaknesses including lack of blinding of intervention and outcome assessors and variability on outcome measures. The quality of the evidence on outcomes assessed according to GRADE was low to very low.\nAuthors' conclusions\nMeta-analysis demonstrated a significant effect of NNS on the transition from gavage to full oral feeding, transition from start of oral feeding to full oral feeding, and length of hospital stay. None of the trials reported any adverse effects. Well-designed, adequately powered studies using reliable methods of randomisation, concealment of treatment allocation and blinding of the intervention and outcome assessors are needed. In order to facilitate meta-analysis of these data, future research should involve outcome measures consistent with those used in previous 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": "An overall analysis suggests that non-nutritive sucking reduces the time infants need to transition from tube to full oral feeding, and from start of oral feeding to full oral feeding. It also reduces the length of hospital stay. Non-nutritive sucking did not demonstrate a positive effect on weight gain."
}
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query-laysum | 2474 | [
{
"role": "user",
"content": "Abstract: Background\nSacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily living. The condition is treated surgically, and in some cases the wound in the natal cleft is left open to heal by itself. Many dressings and topical agents are available to aid healing of these wounds.\nObjectives\nTo assess the effects of dressings and topical agents for the management of open wounds following surgical treatment for sacrococcygeal pilonidal sinus in any care setting.\nSearch methods\nIn March 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and we scanned reference lists of included studies, reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included parallel-group randomised controlled trials (RCTs) only. We included studies with participants who had undergone any type of sacrococcygeal pilonidal sinus disease surgery and were left with an open wound.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs comprising 932 participants. Two studies compared topical negative pressure wound therapy (TNPWT) with conventional open wound healing, two studies compared platelet-rich plasma with sterile absorbent gauze, and the other seven studies compared various dressings and topical agents. All studies were at high risk of bias in at least one domain, whilst one study was judged to be at low risk of bias in all but one domain. All studies were conducted in secondary care. Mean participant ages were between 20 and 30 years, and nearly 80% of participants were male. No studies provided data on quality of life, cost-effectiveness, pain at first dressing change or proportion of wounds healed at 6 or 12 months, and very few adverse effects were recorded in any study.\nIt is unclear whether TNPWT reduces time to wound healing compared with conventional open wound healing (comparison 1), as the certainty of evidence is very low. The two studies provided conflicting results, with one study showing benefit (mean difference (MD) −24.01 days, 95% confidence interval (CI) −35.65 to −12.37; 19 participants), whilst the other reported no difference. It is also unclear whether TNPWT has any effect on the proportion of wounds healed by 30 days (risk ratio (RR) 3.60, 95% CI 0.49 to 26.54; 19 participants, 1 study; very low-certainty evidence). Limited data were available for our secondary outcomes time to return to normal daily activities and recurrence rate; we do not know whether TNPWT has any effect on these outcomes.\nLietofix cream may increase the proportion of wounds that heal by 30 days compared with an iodine dressing (comparison 4; RR 8.06, 95% CI 1.05 to 61.68; 205 participants, 1 study; low-certainty evidence). The study did not provide data on time to wound healing.\nWe do not know whether hydrogel dressings reduce time to wound healing compared with wound cleaning with 10% povidone iodine (comparison 5; MD −24.54 days, 95% CI −47.72 to −1.36; 31 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. It is unclear whether hydrogel dressings have any effect on adverse effects as the certainty of the evidence is very low.\nPlatelet-rich plasma may reduce time to wound healing compared with sterile absorbent gauze (comparison 6; MD −19.63 days, 95% CI −34.69 to −4.57; 210 participants, 2 studies; low-certainty evidence). No studies provided data on the proportion of wounds healed. Platelet-rich plasma may reduce time to return to normal daily activities (MD −15.49, 95% CI −28.95 to −2.02; 210 participants, 2 studies; low-certainty evidence).\nZinc oxide mesh may make little or no difference to time to wound healing compared with placebo (comparison 2; median 54 days in the zinc oxide mesh group versus 62 days in the placebo mesh group; low-certainty evidence). We do not know whether zinc oxide mesh has an effect on the proportion of wounds healed by 30 days as the certainty of the evidence is very low (RR 2.35, 95% CI 0.49 to 11.23).\nIt is unclear whether gentamicin-impregnated collagen sponge reduces time to wound healing compared with no dressing (comparison 7; MD −1.40 days, 95% CI −5.05 to 2.25; 50 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed.\nDialkylcarbamoyl chloride (DACC)-coated dressings may make little or no difference to time to wound healing compared with alginate dressings (comparison 8; median 69 (95% CI 62 to 72) days in the DACC group versus 71 (95% CI 69 to 85) days in the alginate group; 1 study, 246 participants; low-certainty evidence).\nOne study compared a polyurethane foam hydrophilic dressing with an alginate dressing (comparison 3) whilst another study compared a hydrocolloid dressing with an iodine dressing (comparison 9). It is unclear whether either intervention has any effect on time to wound healing as the certainty of evidence is very low.\nAuthors' conclusions\nAt present, the evidence that any of the dressings or topical agents contained in this review have a benefit on time to wound healing, the proportion of wounds that heal at a specific time point or on any of the secondary outcomes of our review ranges from low certainty to very low certainty. There is low-certainty evidence on the benefit on wound healing of platelet-rich plasma from two studies and of Lietofix cream and hydrogel dressings from single studies. Further studies are required to investigate these interventions further.\n\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"
},
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"role": "assistant",
"content": "We wanted to see which dressings and topical agents are better for treating open wounds after surgical treatment for pilonidal sinus of the buttocks.\nFor each intervention we looked at:\n- how long it took wounds to heal;\n- the number of wounds healed after 30 days, 6 months and 1 year;\n- whether the wounds came back;\n- how long it took people who had been treated to return to normal daily activities;\n- quality of life;\n- value for money;\n- pain during the first dressing change;\n- harmful effects (for example surgical site infection or allergic reaction) after treatment."
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query-laysum | 2475 | [
{
"role": "user",
"content": "Abstract: Background\nTreatment guidelines for asthma recommend inhaled corticosteroids (ICS) as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, the potential systemic adverse effects related to regular use of these drugs have been and continue to be a matter of concern, especially the effects on linear growth.\nObjectives\nTo assess the impact of ICS on the linear growth of children with persistent asthma and to explore potential effect modifiers such as characteristics of available treatments (molecule, dose, length of exposure, inhalation device) and of treated children (age, disease severity, compliance with treatment).\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED and PsycINFO; we handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases to look for potential relevant unpublished studies. The literature search was conducted in January 2014.\nSelection criteria\nParallel-group randomised controlled trials comparing daily use of ICS, delivered by any type of inhalation device for at least three months, versus placebo or non-steroidal drugs in children up to 18 years of age with persistent asthma.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction and assessment of risk of bias in included studies. We conducted meta-analyses using the Cochrane statistical package RevMan 5.2 and Stata version 11.0. We used the random-effects model for meta-analyses. We used mean differences (MDs) and 95% CIs as the metrics for treatment effects. A negative value for MD indicates that ICS have suppressive effects on linear growth compared with controls. We performed a priori planned subgroup analyses to explore potential effect modifiers, such as ICS molecule, daily dose, inhalation device and age of the treated child.\nMain results\nWe included 25 trials involving 8471 (5128 ICS-treated and 3343 control) children with mild to moderate persistent asthma. Six molecules (beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone propionate and mometasone furoate) given at low or medium daily doses were used during a period of three months to four to six years. Most trials were blinded and over half of the trials had drop out rates of over 20%.\nCompared with placebo or non-steroidal drugs, ICS produced a statistically significant reduction in linear growth velocity (14 trials with 5717 participants, MD -0.48 cm/y, 95% CI -0.65 to -0.30, moderate quality evidence) and in the change from baseline in height (15 trials with 3275 participants; MD -0.61 cm/y, 95% CI -0.83 to -0.38, moderate quality evidence) during a one-year treatment period.\nSubgroup analysis showed a statistically significant group difference between six molecules in the mean reduction of linear growth velocity during one-year treatment (Chi² = 26.1, degrees of freedom (df) = 5, P value < 0.0001). The group difference persisted even when analysis was restricted to the trials using doses equivalent to 200 μg/d hydrofluoroalkane (HFA)-beclomethasone. Subgroup analyses did not show a statistically significant impact of daily dose (low vs medium), inhalation device or participant age on the magnitude of ICS-induced suppression of linear growth velocity during a one-year treatment period. However, head-to-head comparisons are needed to assess the effects of different drug molecules, dose, inhalation device or patient age. No statistically significant difference in linear growth velocity was found between participants treated with ICS and controls during the second year of treatment (five trials with 3174 participants; MD -0.19 cm/y, 95% CI -0.48 to 0.11, P value 0.22). Of two trials that reported linear growth velocity in the third year of treatment, one trial involving 667 participants showed similar growth velocity between the budesonide and placebo groups (5.34 cm/y vs 5.34 cm/y), and another trial involving 1974 participants showed lower growth velocity in the budesonide group compared with the placebo group (MD -0.33 cm/y, 95% CI -0.52 to -0.14, P value 0.0005). Among four trials reporting data on linear growth after treatment cessation, three did not describe statistically significant catch-up growth in the ICS group two to four months after treatment cessation. One trial showed accelerated linear growth velocity in the fluticasone group at 12 months after treatment cessation, but there remained a statistically significant difference of 0.7 cm in height between the fluticasone and placebo groups at the end of the three-year trial.\nOne trial with follow-up into adulthood showed that participants of prepubertal age treated with budesonide 400 μg/d for a mean duration of 4.3 years had a mean reduction of 1.20 cm (95% CI -1.90 to -0.50) in adult height compared with those treated with placebo.\nAuthors' conclusions\nRegular use of ICS at low or medium daily doses is associated with a mean reduction of 0.48 cm/y in linear growth velocity and a 0.61-cm change from baseline in height during a one-year treatment period in children with mild to moderate persistent asthma. The effect size of ICS on linear growth velocity appears to be associated more strongly with the ICS molecule than with the device or dose (low to medium dose range). ICS-induced growth suppression seems to be maximal during the first year of therapy and less pronounced in subsequent years of treatment. However, additional studies are needed to better characterise the molecule dependency of growth suppression, particularly with newer molecules (mometasone, ciclesonide), to specify the respective role of molecule, daily dose, inhalation device and patient age on the effect size of ICS, and to define the growth suppression effect of ICS treatment over a period of several years in children with persistent asthma.\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": "Treatment guidelines for asthma recommend ICS as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, parents and physicians always remain concerned about the potential negative effect of ICS on growth."
}
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query-laysum | 2476 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease (CVD) is the leading cause of death worldwide. Lifestyle changes are at the forefront of preventing the disease. This includes advice such as increasing physical activity and having a healthy balanced diet to reduce risk factors. Intermittent fasting (IF) is a popular dietary plan involving restricting caloric intake to certain days in the week such as alternate day fasting and periodic fasting, and restricting intake to a number of hours in a given day, otherwise known as time-restricted feeding. IF is being researched for its benefits and many randomised controlled trials have looked at its benefits in preventing CVD.\nObjectives\nTo determine the role of IF in preventing and reducing the risk of CVD in people with or without prior documented CVD.\nSearch methods\nWe conducted our search on 12 December 2019; we searched CENTRAL, MEDLINE and Embase. We also searched three trials registers and searched the reference lists of included papers. Systematic reviews were also viewed for additional studies. There was no language restriction applied.\nSelection criteria\nWe included randomised controlled trials comparing IF to ad libitum feeding (eating at any time with no specific caloric restriction) or continuous energy restriction (CER). Participants had to be over the age of 18 and included those with and without cardiometabolic risk factors. Intermittent fasting was categorised into alternate-day fasting, modified alternate-day fasting, periodic fasting and time-restricted feeding.\nData collection and analysis\nFive review authors independently selected studies for inclusion and extraction. Primary outcomes included all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, and heart failure. Secondary outcomes include the absolute change in body weight, and glucose. Furthermore, side effects such as headaches and changes to the quality of life were also noted. For continuous data, pooled mean differences (MD) (with 95% confidence intervals (CIs)) were calculated. We contacted trial authors to obtain missing data. We used GRADE to assess the certainty of the evidence.\nMain results\nOur search yielded 39,165 records after the removal of duplicates. From this, 26 studies met our criteria, and 18 were included in the pooled analysis. The 18 studies included 1125 participants and observed outcomes ranging from four weeks to six months. Of quantitatively analysed data, seven studies compared IF with ab libitum feeding, eight studies compared IF with CER, and three studies compared IF with both ad libitum feeding and CER. Outcomes were reported at short term (≤ 3 months) and medium term (> 3 months to 12 months) follow-up.\nNone of the included studies reported on all-cause mortality, cardiovascular mortality, stroke, myocardial infarction or heart failure.\nBody weight was reduced with IF compared to ad libitum feeding in the short term (MD -2.88 kg, 95% CI -3.96 to -1.80; 224 participants; 7 studies; low-certainty evidence). We are uncertain of the effect of IF when compared to CER in the short term (MD -0.88 kg, 95% CI -1.76 to 0.00; 719 participants; 10 studies; very low-certainty evidence) and there may be no effect in the medium term (MD -0.56 kg, 95% CI -1.68 to 0.56; 279 participants; 4 studies; low-certainty evidence).\nWe are uncertain about the effect of IF on glucose when compared to ad libitum feeding in the short term (MD -0.03 mmol/L, 95% CI -0.26 to 0.19; 95 participants; 3 studies; very-low-certainty of evidence) and when compared to CER in the short term: MD -0.02 mmol/L, 95% CI -0.16 to 0.12; 582 participants; 9 studies; very low-certainty; medium term: MD 0.01, 95% CI -0.10 to 0.11; 279 participants; 4 studies; low-certainty evidence).\nThe changes in body weight and glucose were not deemed to be clinically significant.\nFour studies reported data on side effects, with some participants complaining of mild headaches. One study reported on the quality of life using the RAND SF-36 score. There was a modest increase in the physical component summary score.\nAuthors' conclusions\nWe are uncertain about the effects of intermittent fasting on clinical events such as mortality, myocardial infarction and heart failure due to lack of data for these outcomes. The individual meta-analyses show that intermittent fasting may be effective in reducing weight when compared to ad libitum feeding and may be as effective as continuous energy restriction. Despite this, these changes appear to be clinically insignificant at short-term follow-up. The quality of the available evidence is low to very low which means that many areas of uncertainty remain. Further research is needed to understand which patient groups would and would not benefit from intermittent fasting (e.g. patients with diabetes or eating disorders) as well as the effect on longer-term outcomes such as all-cause mortality and myocardial infarction.\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 included evidence published up to 12 December 2019."
}
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query-laysum | 2477 | [
{
"role": "user",
"content": "Abstract: Background\nRadiotherapy has been proposed as a treatment for new vessel growth in people with neovascular age-related macular degeneration (AMD).\nObjectives\nTo examine the effects of radiotherapy on neovascular AMD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS and three trials registers and checked references of included studies. We last searched the databases on 4 May 2020.\nSelection criteria\nWe included all randomised controlled trials in which radiotherapy was compared to another treatment, sham treatment, low dosage irradiation or no treatment in people with choroidal neovascularisation (CNV) secondary to AMD.\nData collection and analysis\nWe used standard procedures expected by Cochrane. We graded the certainty of the evidence using GRADE. We considered the following outcomes at 12 months: best-corrected visual acuity (BCVA) (loss of 3 or more lines, change in visual acuity), contrast sensitivity, new vessel growth, quality of life and adverse effects at any time point.\nMain results\nWe included 18 studies (n = 2430 people, 2432 eyes) of radiation therapy with dosages ranging from 7.5 to 24 Gy. These studies mainly took place in Europe and North America but two studies were from Japan and one multicentre study included sites in South America. Three of these studies investigated brachytherapy (plaque and epimacular), the rest were studies of external beam radiotherapy (EBM) including one trial of stereotactic radiotherapy. Four studies compared radiotherapy combined with anti-vascular endothelial growth factor (anti-VEGF) with anti-VEGF alone. Eleven studies gave no radiotherapy treatment to the control group; five studies used sham irradiation; and one study used very low-dose irradiation (1 Gy). One study used a mixture of sham irradiation and no treatment. Fifteen studies were judged to be at high risk of bias in one or more domains.\nRadiotherapy versus no radiotherapy\nThere may be little or no difference in loss of 3 lines of vision at 12 months in eyes treated with radiotherapy compared with no radiotherapy (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.64 to 1.04, 811 eyes, 8 studies, I2 = 66%, low-certainty evidence). Low-certainty evidence suggests a small benefit in change in visual acuity (mean difference (MD) -0.10 logMAR, 95% CI -0.17 to -0.03; eyes = 883; studies = 10) and average contrast sensitivity at 12 months (MD 0.15 log units, 95% CI 0.05 to 0.25; eyes = 267; studies = 2). Growth of new vessels (largely change in CNV size) was variably reported and It was not possible to produce a summary estimate of this outcome. The studies were small with imprecise estimates and there was no consistent pattern to the study results (very low-certainty evidence). Quality of life was only reported in one study of 199 people; there was no clear difference between treatment and control groups (low-certainty evidence). Low-certainty evidence was available on adverse effects from eight of 14 studies. Seven studies reported on radiation retinopathy and/or neuropathy. Five of these studies reported no radiation-associated adverse effects. One study of 88 eyes reported one case of possible radiation retinopathy. One study of 74 eyes graded retinal abnormalities in some detail and found that 72% of participants who had radiation compared with 71% of participants in the control group had retinal abnormalities resembling radiation retinopathy or choroidopathy. Four studies reported cataract surgery or progression: events were generally few with no consistent evidence of any increased occurrence in the radiation group. One study noted transient disturbance of the precorneal tear film but there was no evidence from the other two studies that reported dry eye of any increased risk with radiation therapy. None of the participants received anti-VEGF injections.\nRadiotherapy combined with anti-VEGF versus anti-VEGF alone\nPeople receiving radiotherapy/anti-VEGF were probably more likely to lose 3 or more lines of BCVA at 12 months compared with anti-VEGF alone (RR 2.11, 95% CI 1.40 to 3.17, 1050 eyes, 3 studies, moderate-certainty). Most of the data for this outcome come from two studies of epimacular brachytherapy (114 events) compared with 20 events from the one trial of EBM. Data on change in BCVA were heterogenous (I2 = 82%). Individual study results ranged from a small difference of -0.03 logMAR in favour of radiotherapy/anti-VEGF to a difference of 0.13 logMAR in favour of anti-VEGF alone (low-certainty evidence). The effect differed depending on how the radiotherapy was delivered (test for interaction P = 0.0007). Epimacular brachytherapy was associated with worse visual outcomes (MD 0.10 logMAR, 95% CI 0.05 to 0.15, 820 eyes, 2 studies) compared with EBM (MD -0.03 logMAR, 95% CI -0.09 to 0.03, 252 eyes, 2 studies). None of the included studies reported contrast sensitivity or quality of life. Growth of new vessels (largely change in CNV size) was variably reported in three studies (803 eyes). It was not possible to produce a summary estimate and there was no consistent pattern to the study results (very low-certainty evidence). For adverse outcomes, variable results were reported in the four studies. In three studies reports of adverse events were low and no radiation-associated adverse events were reported. In one study of epimacular brachytherapy there was a higher proportion of ocular adverse events (54%) compared to the anti-VEGF alone (18%). The majority of these adverse events were cataract. Overall 5% of the treatment group had radiation device-related adverse events (17 cases); 10 of these cases were radiation retinopathy. There were differences in average number of injections given between the four studies (1072 eyes). In three of the four studies, the anti-VEGF alone group on average received more injections (moderate-certainty evidence).\nAuthors' conclusions\nThe evidence is uncertain regarding the use of radiotherapy for neovascular AMD. Most studies took place before the routine use of anti-VEGF, and before the development of modern radiotherapy techniques such as stereotactic radiotherapy. Visual outcomes with epimacular brachytherapy are likely to be worse, with an increased risk of adverse events, probably related to vitrectomy. The role of stereotactic radiotherapy combined with anti-VEGF is currently uncertain. Further research on radiotherapy for neovascular AMD may not be justified until current ongoing studies have reported their results.\n\nGiven the provided abstract, please respond to the following query: \"Why this question is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "AMD is a common condition of the eyes that may develop in people aged over 50. It affects the central area (macula) of the back of the eye (retina). First, yellow spots (drusen) develop under the retina. These can been seen by health professionals during examinations of the eyes. As AMD progresses, new blood vessels can grow in the macula. These vessels may bleed or cause scarring; this is called ‘neovascular’ or ‘wet’ AMD. Wet AMD can cause people to lose the central part of their vision.\nThere is no cure for wet AMD. However, there are treatments designed to stop vision from worsening. One such treatment is radiotherapy (using radiation to kill harmful cells). To find out how effective radiotherapy is for treating wet AMD and whether it causes unwanted effects, we reviewed the evidence from research studies."
}
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query-laysum | 2478 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence, and are recognised as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. Anabolic steroids are used as off-label drugs (drugs which are used without regulatory approval) and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics and antiseptics, which are considered to be supportive in healing of pressure ulcers. Anabolic steroids are considered because of their ability to stimulate protein synthesis and build muscle mass. Comprehensive evidence is required to facilitate decision making, regarding the benefits and harms of using anabolic steroids.\nObjectives\nTo assess the effects of anabolic steroids for treating pressure ulcers.\nSearch methods\nIn March 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) comparing the effects of anabolic steroids with alternative treatments or different types of anabolic steroids in the treatment of pressure ulcers.\nData collection and analysis\nTwo review authors independently carried out study selection, data extraction and risk of bias assessment.\nMain results\nThe review contains only one trial with a total of 212 participants, all with spinal cord injury and open pressure ulcers classed as stage III and IV. The participants were mainly male (98.2%, 106/108) with a mean age of 58.4 (standard deviation 10.4) years in the oxandrolone group and were all male (100%, 104/104) with a mean age of 57.3 (standard deviation 11.6) years in the placebo group. This trial compared oxandrolone (20 mg/day, administered orally) with a dose of placebo (an inactive substance consisting of 98% starch and 2% magnesium stearate) and reported data on complete healing of ulcers and adverse events. There was very low-certainty evidence on the relative effect of oxandrolone on complete ulcer healing at the end of a 24-week treatment period (risk ratio RR) 0.81, 95% confidence interval (CI) 0.52 to 1.26) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, we are uncertain whether oxandrolone improves or reduces the complete healing of pressure ulcers, as we assessed the certainty of the evidence as very low.\nThere was low-certainty evidence on the risk of non-serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 3.85, 95% CI 1.12 to 13.26) (downgraded once for imprecision and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, the treatment with oxandrolone may increase the risk of non-serious adverse events reported in participants.\nThere was very low-certainty evidence on the risk of serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 0.54, 95% CI 0.25 to 1.17) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Of the five serious adverse events reported in the oxandrolone-treated group, none were classed by the trial teams as being related to treatment. We are uncertain whether oxandrolone increases or decreases the risk of serious adverse events as we assessed the certainty of the evidence as very low.\nSecondary outcomes such as pain, length of hospital stay, change in wound size or wound surface area, incidence of different type of infection, cost of treatment and quality of life were not reported in the included trial.\nOverall the evidence in this study was of very low quality (downgraded for imprecision and indirectness). This trial stopped early when the futility analysis (interim analysis) in the opinion of the study authors showed that oxandrolone had no benefit over placebo for improving ulcer healing.\nAuthors' conclusions\nThere is no high quality evidence to support the use of anabolic steroids in treating pressure ulcers.\nFurther well-designed, multicenter trials, at low risk of bias, are necessary to assess the effect of anabolic steroids on treating pressure ulcers, but careful consideration of the current trial and its early termination are required when planning future research.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the evidence from this study was judged to be of very low quality. More, better-designed studies are necessary to provide evidence as to whether anabolic steroids are beneficial or not in treating pressure ulcers.\nThis plain language summary is up to date as of March 2017."
}
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query-laysum | 2479 | [
{
"role": "user",
"content": "Abstract: Background\nTardive dyskinesia (TD) remains a troublesome adverse effect of conventional antipsychotic (neuroleptic) medication. It has been proposed that TD could have a component of central cholinergic deficiency. Cholinergic drugs have been used to treat TD.\nObjectives\nTo determine the effects of cholinergic drugs (arecoline, choline, deanol, lecithin, meclofenoxate, physostigmine, RS 86, tacrine, metoxytacrine, galantamine, ipidacrine, donepezil, rivastigmine, eptastigmine, metrifonate, xanomeline, cevimeline) for treating antipsychotic-induced TD in people with schizophrenia or other chronic mental illness.\nSearch methods\nAn electronic search of the Cochrane Schizophrenia Group's Study-Based Register of Trials (16 July 2015 and April 2017) was undertaken. This register is assembled by extensive searches for randomised controlled trials in many electronic databases, registers of trials, conference proceedings and dissertations. References of all identified studies were searched for further trial citations.\nSelection criteria\nWe included reports identified by the search if they were of controlled trials involving people with antipsychotic-induced TD and chronic mental illness, who had been randomly allocated to either a cholinergic agent or to a placebo or no intervention. Two review authors independently assessed the methodological quality of the trials.\nData collection and analysis\nTwo review authors extracted data and, where possible, estimated risk ratios (RR) or mean differences (MD), with 95% confidence intervals (CI). We analysed data on an intention-to-treat basis, with the assumption that people who left early had no improvement. We assessed risk of bias and created a 'Summary of findings' table using GRADE.\nMain results\nWe included 14 studies investigating the use of cholinergic drugs compared with placebo published between 1976 and 2014. All studies involved small numbers of participants (five to 60 people). Three studies that investigated the new cholinergic Alzheimer drugs for the treatment of TD are new to this update. Overall, the risk of bias in the included studies was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, studies were not clearly blinded, we are unsure if data are incomplete, and data were often poorly or selectively reported.\nWe are uncertain about the effect of new or old cholinergic drugs on no clinically important improvement in TD symptoms when compared with placebo; the quality of evidence was very low (RR 0.89, 95% CI 0.65 to 1.23; 27 people, 4 RCTs). Eight trials found that cholinergic drugs may make little or no difference to deterioration of TD symptoms (low-quality evidence, RR 1.11, 95% CI 0.55 to 2.24; 147 people). Again, due to very low-quality evidence, we are uncertain about the effects on mental state (RR 0.50, 95% CI 0.10 to 2.61; 77 people, 5 RCTs), adverse events (RR 0.56, 95% CI 0.15 to 2.14; 106 people, 4 RCTs), and leaving the study early (RR 1.09,95% CI 0.56 to 2.10; 288 people 12 RCTs). No study reported on social confidence, social inclusion, social networks, or personalised quality of life.\nAuthors' conclusions\nTD remains a major public health problem. The clinical effects of both older cholinergic drugs and new cholinergic agents, now used for treating Alzheimer's disease, are unclear, as too few, too small studies leave many questions unanswered. Cholinergic drugs should remain of interest to researchers and currently have little place in routine clinical work. However, with the advent of new cholinergic agents now used for treating Alzheimer's disease, scope exists for more informative trials. If these new cholinergic agents are to be investigated for treating people with TD, their effects should be demonstrated in large well-designed, conducted and reported randomised trials.\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": ".\nAre cholinergic drugs useful for treating the unpleasant side-effect - tardive dyskinesia - in people with schizophrenia or other similar mental health problems who are taking antipsychotics."
}
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query-laysum | 2480 | [
{
"role": "user",
"content": "Abstract: Background\nSitting can be viewed as a therapeutic intervention and an important part of a person's recovery process; but the risk of ulceration must be mitigated. Interventions for ulcer prevention in those at risk from prolonged sitting include the use of specialist cushions and surfaces, especially for wheelchair users. Whilst there is interest in the effects of different pressure redistributing cushions for wheelchairs, the benefits of pressure redistributing static chairs, compared with standard chairs, for pressure ulcer development in at-risk people are not clear.\nObjectives\nTo assess the effects of pressure redistributing static chairs on the prevention of pressure ulcers in health, rehabilitation and social care settings, and places of residence in which people may spend their day.\nSearch methods\nIn June 2021 we searched the following electronic databases to identify reports of relevant randomised clinical trials: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature). We also searched clinical trials registers for ongoing and unpublished studies, and reference lists of relevant systematic reviews, meta-analyses and health technology reports. There were no restrictions by language, date of publication or study setting.\nSelection criteria\nWe sought to include published or unpublished randomised controlled trials that assessed pressure redistributing static chairs in the prevention or management of pressure ulcers.\nData collection and analysis\nTwo review authors independently performed study selection. We planned that two review authors would also assess the risk of bias, extract study data and assess the certainty of evidence according to GRADE methodology.\nMain results\nWe did not identify any studies that met the review eligibility criteria, nor any registered studies investigating the role of pressure redistributing static chairs in the prevention or management of pressure ulcers.\nAuthors' conclusions\nCurrently, there is no randomised evidence that supports or refutes the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. This is a priority area and there is a need to explore this intervention with rigorous and robust research.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any eligible completed or registered studies investigating the effects of pressure redistributing static chairs for preventing or managing pressure ulcers.\nThere is no current high-quality evidence that supports or refutes the role of pressure redistributing static chairs for preventing or managing pressure ulcers.\nThis is a priority area and there is a need to explore this intervention with rigorous and robust research."
}
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query-laysum | 2481 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of a rapid review undertaken in 2020 to identify relevant, feasible and effective communication approaches to promote acceptance, uptake and adherence to physical distancing measures for COVID-19 prevention and control. The rapid review was published when little was known about transmission, treatment or future vaccination, and when physical distancing measures (isolation, quarantine, contact tracing, crowd avoidance, work and school measures) were the cornerstone of public health responses globally.\nThis updated review includes more recent evidence to extend what we know about effective pandemic public health communication. This includes considerations of changes needed over time to maintain responsiveness to pandemic transmission waves, the (in)equities and variable needs of groups within communities due to the pandemic, and highlights again the critical role of effective communication as integral to the public health response.\nObjectives\nTo update the evidence on the question 'What are relevant, feasible and effective communication approaches to promote acceptance, uptake and adherence to physical distancing measures for COVID-19 prevention and control?', our primary focus was communication approaches to promote and support acceptance, uptake and adherence to physical distancing.\nSecondary objective: to explore and identify key elements of effective communication for physical distancing measures for different (diverse) populations and groups.\nSearch methods\nWe searched MEDLINE, Embase and Cochrane Library databases from inception, with searches for this update including the period 1 January 2020 to 18 August 2021. Systematic review and study repositories and grey literature sources were searched in August 2021 and guidelines identified for the eCOVID19 Recommendations Map were screened (November 2021).\nSelection criteria\nGuidelines or reviews focusing on communication (information, education, reminders, facilitating decision-making, skills acquisition, supporting behaviour change, support, involvement in decision-making) related to physical distancing measures for prevention and/or control of COVID-19 or selected other diseases (sudden acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), influenza, Ebola virus disease (EVD) or tuberculosis (TB)) were included. New evidence was added to guidelines, reviews and primary studies included in the 2020 review.\nData collection and analysis\nMethods were based on the original rapid review, using methods developed by McMaster University and informed by Cochrane rapid review guidance.\nScreening, data extraction, quality assessment and synthesis were conducted by one author and checked by a second author. Synthesis of results was conducted using modified framework analysis, with themes from the original review used as an initial framework.\nMain results\nThis review update includes 68 studies, with 17 guidelines and 20 reviews added to the original 31 studies.\nSynthesis identified six major themes, which can be used to inform policy and decision-making related to planning and implementing communication about a public health emergency and measures to protect the community.\nTheme 1: Strengthening public trust and countering misinformation: essential foundations for effective public health communication\nRecognising the key role of public trust is essential. Working to build and maintain trust over time underpins the success of public health communications and, therefore, the effectiveness of public health prevention measures.\nTheme 2: Two-way communication: involving communities to improve the dissemination, accessibility and acceptability of information\nTwo-way communication (engagement) with the public is needed over the course of a public health emergency: at first, recognition of a health threat (despite uncertainties), and regularly as public health measures are introduced or adjusted. Engagement needs to be embedded at all stages of the response and inform tailoring of communications and implementation of public health measures over time.\nTheme 3: Development of and preparation for public communication: target audience, equity and tailoring\nCommunication and information must be tailored to reach all groups within populations, and explicitly consider existing inequities and the needs of disadvantaged groups, including those who are underserved, vulnerable, from diverse cultural or language groups, or who have lower educational attainment. Awareness that implementing public health measures may magnify existing or emerging inequities is also needed in response planning, enactment and adjustment over time.\nTheme 4: Public communication features: content, timing and duration, delivery\nPublic communication needs to be based on clear, consistent, actionable and timely (up-to-date) information about preventive measures, including the benefits (whether for individual, social groupings or wider society), harms (likewise) and rationale for use, and include information about supports available to help follow recommended measures. Communication needs to occur through multiple channels and/or formats to build public trust and reach more of the community.\nTheme 5: Supporting behaviour change at individual and population levels\nSupporting implementation of public health measures with practical supports and services (e.g. essential supplies, financial support) is critical. Information about available supports must be widely disseminated and well understood. Supports and communication related to them require flexibility and tailoring to explicitly consider community needs, including those of vulnerable groups. Proactively monitoring and countering stigma related to preventive measures (e.g. quarantine) is also necessary to support adherence.\nTheme 6: Fostering and sustaining receptiveness and responsiveness to public health communication\nEfforts to foster and sustain public receptiveness and responsiveness to public health communication are needed throughout a public health emergency. Trust, acceptance and behaviours change over time, and communication needs to be adaptive and responsive to these changing needs. Ongoing community engagement efforts should inform communication and public health response measures.\nAuthors' conclusions\nImplications for practice\nEvidence highlights the critical role of communication throughout a public health emergency. Like any intervention, communication can be done well or poorly, but the consequences of poor communication during a pandemic may mean the difference between life and death.\nThe approaches to effective communication identified in this review can be used by policymakers and decision-makers, working closely with communication teams, to plan, implement and adjust public communications over the course of a public health emergency like the COVID-19 pandemic.\nImplications for research\nDespite massive growth in research during the COVID-19 period, gaps in the evidence persist and require high-quality, meaningful research. This includes investigating the experiences of people at heightened COVID-19 risk, and identifying barriers to implementing public communication and protective health measures particular to lower- and middle-income countries, and how to overcome these.\n\nGiven the provided abstract, please respond to the following query: \"What are physical distancing measures?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The term 'physical distancing measures' describes ways to reduce the spread of diseases such as COVID-19 by reducing physical contact between people. Physical distancing measures include contact tracing, avoiding crowds, isolating, quarantine, and measures to reduce transmission in schools and workplaces."
}
]
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query-laysum | 2482 | [
{
"role": "user",
"content": "Abstract: Background\nExposure to light plays a crucial role in biological processes, influencing mood and alertness. Daytime workers may be exposed to insufficient or inappropriate light during daytime, leading to mood disturbances and decreases in levels of alertness.\nObjectives\nTo assess the effectiveness and safety of lighting interventions to improve alertness and mood in daytime workers.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, seven other databases; ClinicalTrials.gov and the World Health Organization trials portal up to January 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs), and non-randomised controlled before-after trials (CBAs) that employed a cross-over or parallel-group design, focusing on any type of lighting interventions applied for daytime workers.\nData collection and analysis\nTwo review authors independently screened references in two stages, extracted outcome data and assessed risk of bias. We used standardised mean differences (SMDs) and 95% confidence intervals (CI) to pool data from different questionnaires and scales assessing the same outcome across different studies. We combined clinically homogeneous studies in a meta-analysis. We used the GRADE system to rate quality of evidence.\nMain results\nThe search yielded 2844 references. After screening titles and abstracts, we considered 34 full text articles for inclusion. We scrutinised reports against the eligibility criteria, resulting in the inclusion of five studies (three RCTs and two CBAs) with 282 participants altogether. These studies evaluated four types of comparisons: cool-white light, technically known as high correlated colour temperature (CCT) light versus standard illumination; different proportions of indirect and direct light; individually applied blue-enriched light versus no treatment; and individually applied morning bright light versus afternoon bright light for subsyndromal seasonal affective disorder.\nWe found no studies comparing one level of illuminance versus another.\nWe found two CBA studies (163 participants) comparing high CCT light with standard illumination. By pooling their results via meta-analysis we found that high CCT light may improve alertness (SMD −0.69, 95% CI −1.28 to −0.10; Columbia Jet Lag Scale and the Karolinska Sleepiness Scale) when compared to standard illumination. In one of the two CBA studies with 94 participants there was no difference in positive mood (mean difference (MD) 2.08, 95% CI −0.1 to 4.26) or negative mood (MD −0.45, 95% CI −1.84 to 0.94) assessed using the Positive and Negative Affect Schedule (PANAS) scale. High CCT light may have fewer adverse events than standard lighting (one CBA; 94 participants). Both studies were sponsored by the industry. We graded the quality of evidence as very low.\nWe found no studies comparing light of a particular illuminance and light spectrum or CCT versus another combination of illuminance and light spectrum or CCT.\nWe found no studies comparing daylight versus artificial light.\nWe found one RCT (64 participants) comparing the effects of different proportions of direct and indirect light: 100% direct lighting, 70% direct lighting plus 30% indirect lighting, 30% direct lighting plus 70% indirect lighting and 100% indirect lighting. There was no substantial difference in mood, as assessed by the Beck Depression Inventory, or in adverse events, such as ocular, reading or concentration problems, in the short or medium term. We graded the quality of evidence as low.\nWe found two RCTs comparing individually administered light versus no treatment. According to one RCT with 25 participants, blue-enriched light individually applied for 30 minutes a day may enhance alertness (MD −3.30, 95% CI −6.28 to −0.32; Epworth Sleepiness Scale) and may improve mood (MD −4.8, 95% CI −9.46 to −0.14; Beck Depression Inventory). We graded the quality of evidence as very low. One RCT with 30 participants compared individually applied morning bright light versus afternoon bright light for subsyndromal seasonal affective disorder. There was no substantial difference in alertness levels (MD 7.00, 95% CI −10.18 to 24.18), seasonal affective disorder symptoms (RR 1.60, 95% CI 0.81, 3.20; number of participants presenting with a decrease of at least 50% in SIGH-SAD scores) or frequency of adverse events (RR 0.53, 95% CI 0.26 to 1.07). Among all participants, 57% had a reduction of at least 50% in their SIGH-SAD score. We graded the quality of evidence as low.\nPublication bias could not be assessed for any of these comparisons.\nAuthors' conclusions\nThere is very low-quality evidence based on two CBA studies that high CCT light may improve alertness, but not mood, in daytime workers. There is very low-quality evidence based on one CBA study that high CCT light may also cause less irritability, eye discomfort and headache than standard illumination. There is low-quality evidence based on one RCT that different proportions of direct and indirect light in the workplace do not affect alertness or mood. There is very low-quality evidence based on one RCT that individually applied blue-enriched light improves both alertness and mood. There is low-quality evidence based on one RCT that individually administered bright light during the afternoon is as effective as morning exposure for improving alertness and mood in subsyndromal seasonal affective disorder.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included five studies, with 282 participants. Participants were office and hospital workers. Two studies investigated the effect of cool white light and one study focused on indirect light sources. Two studies investigated the effect of individually administered light using special glasses or a light box (a flat box with a side of translucent glass or plastic that contains a light).\nCool white light may improve alertness, but not mood, and it may cause less irritability, eye discomfort and headache. These findings are based on two studies sponsored by the industry.\nChanging the proportions of direct and indirect light in the workplace may not substantially affect alertness or mood.\nBlue-enriched light provided using glasses with mounted LEDs may improve alertness and mood.\nIndividual exposure to bright light using a light box during the afternoon may improve alertness and mood just as well as individual exposure to bright light in the morning in people exhibiting symptoms that are not severe enough for the diagnosis of seasonal depression.\nAll findings are based on low or very low-quality evidence (due to the small number of studies and participants, and problems in how the studies were conducted), therefore, additional studies are still needed.\nWe found no studies that investigated the effects of: light intensity, light intensity combined with light colour, or exposure to daylight."
}
]
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query-laysum | 2483 | [
{
"role": "user",
"content": "Abstract: Background\nDental implants are used for replacing missing teeth. Placing dental implants is limited by the presence of adequate bone volume permitting their anchorage. Several bone augmentation procedures have been developed to solve this problem. Zygomatic implants are long screw-shaped implants developed as a partial or complete alternative to bone augmentation procedures for the severely atrophic maxilla. One to three zygomatic implants can be inserted through the posterior alveolar crest passing through the maxillary sinus, or externally to it, to engage the body of the zygomatic bone. A couple of conventional dental implants may also be needed in the frontal region of the maxilla to stabilise the prosthesis. The potential main advantages of zygomatic implants could be that bone grafting may not be needed and a fixed prosthesis could be fitted sooner. Another specific indication for zygomatic implants could be maxillary reconstruction after maxillectomy in cancer patients.\nObjectives\nTo assess the effects of zygomatic implants with and without bone augmenting procedures in comparison with conventional dental implants in augmented bone for the rehabilitation with implant-supported prostheses of severely resorbed maxillae.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group'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). Personal contacts and all known zygomatic implant manufacturers were contacted to identify unpublished trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) including participants with severely resorbed maxillae, who could not be rehabilitated with conventional dental implants, treated with zygomatic implants with and without bone grafts versus participants treated with bone augmentation procedures and conventional dental implants, with a follow-up of at least one year in function.\nData collection and analysis\nTwo review authors would have extracted data from eligible studies and assessed their risk of bias independently and in duplicate. The results of included studies were to be combined in meta-analyses using random-effects models where there were more than four studies, and fixed-effect models where there were less than four studies. We would have expressed the estimate of the intervention effect as mean difference for continuous outcomes and risk ratio for dichotomous outcomes, with 95% confidence intervals. Heterogeneity was to be investigated including both clinical and methodological factors.\nMain results\nWe did not identify any RCTs which were eligible for inclusion in this review.\nAuthors' conclusions\nThere is a need for RCTs in this area to assess whether zygomatic implants offer some advantages over alternative bone augmentation techniques for treating atrophic maxillae.\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": "Sometimes there is not enough bone in the upper jaw in which to secure dental implants. Sometimes bone is taken from somewhere else in the person's body, or bone substitutes are used. An alternative approach is to place one to three long screw-shaped implants into the sinus and the cheekbone (zygomatic implants). This may mean that bone grafting is unnecessary. The implants can then be used to build and secure artificial teeth."
}
]
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query-laysum | 2484 | [
{
"role": "user",
"content": "Abstract: Background\nAutologous platelet-rich plasma (PRP) is a treatment that contains fibrin and high concentrations of growth factors with the potential to improve the healing of chronic wounds. This is the first update of a review first published in 2012.\nObjectives\nTo determine whether autologous PRP promotes the healing of chronic wounds.\nSearch methods\nIn June 2015, for this first update, 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 for ongoing and unpublished clinical trials in the WHO International Clinical Trials Registry Platform (ICTRP) (searched January 2015). We did not impose any restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared autologous PRP with placebo or alternative treatments for any type of chronic wound in adults. We did not apply any date or language restrictions.\nData collection and analysis\nWe used standard Cochrane methodology, including two reviewers independently selecting studies for inclusion, extracting data, and assessing risk of bias.\nMain results\nThe search identified one new RCT, making a total of 10 included RCTs (442 participants, 42% women). The median number of participants per RCT was 29 (range 10 to 117). Four RCTs recruited people with a range of chronic wounds; three RCTs recruited people with venous leg ulcers, and three RCTs considered foot ulcers in people with diabetes. The median length of treatment was 12 weeks (range 8 to 40 weeks).\nIt is unclear whether autologous PRP improves the healing of chronic wounds generally compared with standard treatment (with or without placebo) (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.95 to 1.50; I2 = 27%, low quality evidence, 8 RCTs, 391 participants). Autologous PRP may increase the healing of foot ulcers in people with diabetes compared with standard care (with or without placebo) (RR 1.22, 95% CI 1.01 to 1.49; I2 = 0%, low quality evidence, 2 RCTs, 189 participants). It is unclear if autologous PRP affects the healing of venous leg ulcers (RR 1.02, 95% CI 0.81 to 1.27; I2 = 0% ). It is unclear if there is a difference in the risk of adverse events in people treated with PRP or standard care (RR 1.05, 95% CI 0.29 to 3.88; I2 = 0%, low quality evidence from 3 trials, 102 participants).\nAuthors' conclusions\nPRP may improve the healing of foot ulcers associated with diabetes, but this conclusion is based on low quality evidence from two small RCTs. It is unclear whether PRP influences the healing of other chronic wounds. The overall quality of evidence of autologous PRP for treating chronic wounds is low. There are very few RCTs evaluating PRP, they are underpowered to detect treatment effects, if they exist, and are generally at high or unclear risk of bias. Well designed and adequately powered clinical trials 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": "Chronic wounds (or ulcers) are breaks in the skin that do not heal, or require a long time to heal, and frequently recur. Chronic wounds include pressure ulcers, venous leg ulcers, arterial ulcers, neurotrophic ulcers, and foot ulcers in people with diabetes. Autologous platelet-rich plasma (PRP) is a potential wound healing treatment because it has components such as fibrin (a substance produced in the liver that makes the blood clot) and high concentrations of growth factors that are thought to help healing. We reviewed the evidence on the effect of autologous PRP on wound healing in people aged 18 years or older with chronic wounds from any cause (such as pressure ulcers, arterial ulcers, venous ulcers). We also included patients with wounds of mixed aetiology e.g. mixed arterial-venous ulcers."
}
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query-laysum | 2485 | [
{
"role": "user",
"content": "Abstract: Background\nAnti–tumour necrosis factor (TNF) agents are effective in treating people with rheumatoid arthritis (RA), but are associated with (dose-dependent) adverse effects and high costs. To prevent overtreatment, several trials have assessed the effectiveness of down-titration compared with continuation of the standard dose. This is an update of a Cochrane Review published in 2014.\nObjectives\nTo evaluate the benefits and harms of down-titration (dose reduction, discontinuation, or disease activity-guided dose tapering) of anti-TNF agents on disease activity, functioning, costs, safety, and radiographic damage compared with usual care in people with RA and low disease activity.\nSearch methods\nWe searched MEDLINE, Embase, Web of Science and CENTRAL (29 March 2018) and four trial registries (11 April 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies. We screened conference proceedings (American College of Rheumatology and European League Against Rheumatism 2005-2017).\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing down-titration (dose reduction, discontinuation, disease activity–guided dose tapering) of anti-TNF agents (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) to usual care/no down-titration in people with RA and low disease activity.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nOne previously included trial was excluded retrospectively in this update because it was not an RCT/CCT. We included eight additional trials, for a total of 14 studies (13 RCTs and one CCT, 3315 participants in total) reporting anti-TNF down-titration. Six studies (1148 participants) reported anti-TNF dose reduction compared with anti-TNF continuation. Eight studies (2111 participants) reported anti-TNF discontinuation compared with anti-TNF continuation (three studies assessed both anti-TNF discontinuation and dose reduction), and three studies assessed disease activity–guided anti-TNF dose tapering (365 participants). These studies included data on all anti-TNF agents, but primarily adalimumab and etanercept. Thirteen studies were available in full text, one was available as abstract. We assessed the included studies generally at low to moderate risk of bias; our main concerns were bias due to open-label treatment and unblinded outcome assessment. Clinical heterogeneity between the trials was high. The included studies were performed at clinical centres around the world and included people with early as well as established RA, the majority of whom were female with mean ages between 47 and 60. Study durations ranged from 6 months to 3.5 years.\nWe found that anti-TNF dose reduction leads to little or no difference in mean disease activity score (DAS28) after 26 to 52 weeks (high-certainty evidence, mean difference (MD) 0.06, 95% confidence interval (CI) −0.11 to 0.24, absolute risk difference (ARD) 1%) compared with continuation. Also, anti-TNF dose reduction does not result in an important deterioration in function after 26 to 52 weeks (Health Assessment Questionnaire Disability Index (HAQ-DI)) (high-certainty evidence, MD 0.09, 95% CI 0.00 to 0.19, ARD 3%). Next to this, anti-TNF dose reduction may slightly reduce the proportion of participants switched to another biologic (low-certainty evidence), but probably slightly increases the proportion of participants with minimal radiographic progression after 52 weeks (moderate-certainty evidence, risk ratio (RR) 1.22, 95% CI 0.76 to 1.95, ARD 2% higher). Anti-TNF dose reduction may cause little or no difference in serious adverse events, withdrawals due to adverse events and proportion of participants with persistent remission (low-certainty evidence).\nResults show that anti-TNF discontinuation probably slightly increases the mean disease activity score (DAS28) after 28 to 52 weeks (moderate-certainty evidence, MD 0.96, 95% CI 0.67 to 1.25, ARD 14%), and that the RR of persistent remission lies between 0.16 and 0.77 (low-certainty evidence). Anti-TNF discontinuation increases the proportion participants with minimal radiographic progression after 52 weeks (high-certainty evidence, RR 1.69, 95% CI 1.10 to 2.59, ARD 7%) and may lead to a slight deterioration in function (HAQ-DI) (low-certainty evidence). It is uncertain whether anti-TNF discontinuation influences the number of serious adverse events (due to very low-certainty evidence) and the number of withdrawals due to adverse events after 28 to 52 weeks probably increases slightly (moderate-certainty evidence, RR 1.46, 95% CI 0.75 to 2.84, ARD 1% higher).\nAnti-TNF disease activity–guided dose tapering may result in little or no difference in mean disease activity score (DAS28) after 72 to 78 weeks (low-certainty evidence). Furthermore, anti-TNF disease activity–guided dose tapering results in little or no difference in the proportion of participants with persistent remission after 18 months (high-certainty evidence, RR 0.89, 95% CI 0.75 to 1.06, ARD −9%) and may result in little or no difference in switching to another biologic (low-certainty evidence). Anti-TNF disease activity–guided dose tapering may slightly increase proportion of participants with minimal radiographic progression (low-certainty evidence) and probably leads to a slight deterioration of function after 18 months (moderate-certainty evidence, MD 0.2 higher, 0.02 lower to 0.42 higher, ARD 7% higher), It is uncertain whether anti-TNF disease activity-guided dose tapering influences the number of serious adverse events due to very low-certainty evidence.\nAuthors' conclusions\nWe found that fixed-dose reduction of anti-TNF, after at least three to 12 months of low disease activity, is comparable to continuation of the standard dose regarding disease activity and function, and may be comparable with regards to the proportion of participants with persistent remission. Discontinuation (also without disease activity–guided adaptation) of anti-TNF is probably inferior to continuation of treatment with respect to disease activity, the proportion of participants with persistent remission, function, and minimal radiographic damage. Disease activity–guided dose tapering of anti-TNF is comparable to continuation of treatment with respect to the proportion of participants with persistent remission and may be comparable regarding disease activity.\nCaveats of this review are that available data are mainly limited to etanercept and adalimumab, the heterogeneity between studies, and the use of superiority instead of non-inferiority designs.\nFuture research should focus on the anti-TNF agents infliximab and golimumab; assessment of disease activity, function, and radiographic outcomes after longer follow-up; and assessment of long-term safety, cost-effectiveness, and predictors for successful down-titration. Also, use of a validated flare criterion, non-inferiority designs, and disease activity–guided tapering instead of fixed-dose reduction or discontinuation would allow researchers to better interpret study findings and generalise to clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Side effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- There was little or no difference in number of serious adverse events in people lowering the dose of anti-TNF compared to continuation anti-TNF (low-certainty evidence).\n- It is uncertain whether gradually lowering the dose of or stopping anti-TNF influences the number of serious adverse events (very low-certainty evidence)."
}
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query-laysum | 2486 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is a recurrent illness with high rates of chronicity, treatment-resistance and significant economic impact. There is evidence in the literature that S-adenosyl methionine (SAMe), a naturally occurring compound in the human body, has antidepressant efficacy. This product may be an important addition to the armamentarium of antidepressant agents.\nObjectives\nTo assess the effects of SAMe in comparison with placebo or antidepressants for the treatment of depression in adults.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group's Specialised Register (CCMDCTR Studies and Reference Register), MEDLINE, EMBASE, PsycINFO, international trial registers ClinicalTrials.gov and the World Health Organization trials portal (ICTRP). We checked reference lists, performed handsearching and contacted experts in the field. The CCMDCTR literature search was last updated on 5 February 2016.\nSelection criteria\nRandomised controlled trials comparing SAMe with placebo or antidepressants in adults with a diagnosis of major depression.\nData collection and analysis\nTwo authors independently performed extraction of data and assessment of risk of bias. We contacted trialists of included studies for additional information.\nMain results\nThis systematic review included eight trials comparing SAMe with either placebo, imipramine, desipramine or escitalopram. We accepted trials that used SAMe as monotherapy or as add-on therapy to selective serotonin reuptake inhibitors (SSRIs), and we accepted both oral and parenteral administration. The review involved 934 adults, of both sexes, from inpatient and outpatient settings.\nThe trials were at low risk of reporting bias. We judged the risk of selection, performance, detection and attrition bias as unclear or low, and one study was at high risk of attrition bias.\nThere was no strong evidence of a difference in terms of change in depressive symptoms from baseline to end of treatment between SAMe and placebo as monotherapy (standardised mean difference (SMD) -0.54, 95% confidence interval (CI) -1.54 to 0.46; P = 0.29; 142 participants; 2 studies; very low quality evidence). There was also no strong evidence of a difference in terms of drop-out rates due to any reason between SAMe and placebo, when used as monotherapy (risk ratio (RR) 0.88, 95% CI 0.61 to 1.29; P = 0.52; 142 participants; 2 studies; low quality evidence).\nLow quality evidence showed that the change in depressive symptoms from baseline to end of treatment was similar between SAMe and imipramine, both as monotherapy (SMD -0.04, 95% CI -0.34 to 0.27; P = 0.82; 619 participants; 4 studies). There was also no strong evidence of a difference between SAMe and a tricyclic antidepressant in terms of drop-outs due to any reason (RR 0.61, 95% CI 0.28 to 1.31; P = 0.2; 78 participants; 3 studies; very low quality evidence).\nThere was little evidence of a difference in terms of change in depressive symptoms from baseline to end of treatment between SAMe and escitalopram, both as monotherapy (MD 0.12, 95% CI -2.75 to 2.99; P = 0.93; 129 participants; 1 study; low quality evidence). There was no strong evidence of a difference between SAMe and escitalopram in terms of drop-outs due to any reason (RR 0.81, 95% CI 0.57 to 1.16; P = 0.26; 129 participants; 1 study; low quality evidence).\nThere was low quality evidence that SAMe is superior to placebo as add-on to SSRIs in terms of change in depressive symptoms from baseline to end of treatment (MD -3.90, 95% CI -6.93 to -0.87; P = 0.01; 73 participants; 1 study). There was no strong evidence of a difference between SAMe and placebo as adjunctive therapy to an SSRI in terms of drop-outs due to any reason (RR 0.70, 95% CI 0.31 to 1.56; P = 0.38; 73 participants; 1 study; very low quality evidence).\nFor all comparisons, secondary outcome measures of response and remission rates were consistent with these primary outcome measures.\nWith regard to all extractable measures of the acceptability of SAMe, the quality of the evidence was low to very low. SAMe was not different from placebo and established antidepressants. The exception was that compared to imipramine, fewer participants experienced troublesome adverse effects when treated with parenteral SAMe.\nThe specific adverse effects were not detailed in most of the included studies. There were two reports of mania/hypomania recorded for 441 participants in the SAMe arm.\nAuthors' conclusions\nGiven the absence of high quality evidence and the inability to draw firm conclusions based on that evidence, the use of SAMe for the treatment of depression in adults should be investigated further. Future trials should be in the form of large randomised controlled clinical trials of high methodological quality, with particular attention given to randomisation, allocation concealment, blinding and the handling of missing data. Comparator antidepressants from all classes should be used. Adverse events should be detailed for each participant, bearing in mind that induction of mania is of particular interest.\n\nGiven the provided abstract, please respond to the following query: \"Description of the illness\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Depression is a common, recurrent mood disorder. Usually, affected people experience symptoms such as low mood and a loss of interest or pleasure. People with depression also often experience some of the following symptoms: weight loss or gain; a decrease or increase in appetite, insomnia or hypersomnia; restlessness or fatigue as well as excessive guilt; feelings of worthlessness, poor concentration and indecisiveness; recurrent thoughts of death and suicidal thoughts. The medicines most often used in the treatment of depression are antidepressants."
}
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query-laysum | 2487 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers.\nObjectives\nTo assess the effects of non-foam and non-air-filled reactive beds, mattresses or overlays compared with any other support surface on the incidence of pressure ulcers in any population in any setting.\nSearch methods\nIn November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials that allocated participants of any age to non-foam or non-air-filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used.\nData collection and analysis\nAt least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a non-foam or non-air-filled surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses.\nMain results\nWe included 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias.\nPrimary outcome: Pressure ulcer incidence\nWe did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I2 = 0%; low-certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty.\nIncluded studies did not report time to pressure ulcer incidence for any comparison in this review.\nSecondary outcomes\nSupport-surface-associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low-certainty evidence).\nAll reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low-certainty evidence).\nWe did not find any health-related quality of life or cost-effectiveness evidence for any comparison in this review.\nAuthors' conclusions\nCurrent evidence is generally uncertain about the differences between non-foam and non-air-filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health-related quality of life and cost-effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds.\nFuture research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta-analysis adds to the findings reported here.\n\nGiven the provided abstract, please respond to the following query: \"What limited our confidence in the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies were small (198 people on average) and used methods likely to introduce errors in their results."
}
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query-laysum | 2488 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) recommends at least four antenatal care (ANC) visits for all pregnant women. Almost half of pregnant women worldwide, and especially in developing countries do not receive this amount of care. Poor attendance of ANC is associated with delivery of low birthweight babies and more neonatal deaths. ANC may include education on nutrition, potential problems with pregnancy or childbirth, child care and prevention or detection of disease during pregnancy.\nThis review focused on community-based interventions and health systems-related interventions.\nObjectives\nTo assess the effects of health system and community interventions for improving coverage of antenatal care and other perinatal health outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 June 2015) and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-randomised trials and cluster-randomised trials. Trials of any interventions to improve ANC coverage were eligible for inclusion. Trials were also eligible if they targeted specific and related outcomes, such as maternal or perinatal death, but also reported ANC coverage.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nWe included 34 trials involving approximately 400,000 women. Some trials tested community-based interventions to improve uptake of antenatal care (media campaigns, education or financial incentives for pregnant women), while other trials looked at health systems interventions (home visits for pregnant women or equipment for clinics). Most trials took place in low- and middle-income countries, and 29 of the 34 trials used a cluster-randomised design. We assessed 30 of the 34 trials as of low or unclear overall risk of bias.\nComparison 1: One intervention versus no intervention\nWe found marginal improvements in ANC coverage of at least four visits (average odds ratio (OR) 1.11, 95% confidence interval (CI) 1.01 to 1.22; participants = 45,022; studies = 10; Heterogeneity: Tau² = 0.01; I² = 52%; high quality evidence). Sensitivity analysis with a more conservative intra-cluster correlation co-efficient (ICC) gave similar marginal results. Excluding one study at high risk of bias shifted the marginal pooled estimate towards no effect. There was no effect on pregnancy-related deaths (average OR 0.69, 95% CI 0.45 to 1.08; participants = 114,930; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; low quality evidence), perinatal mortality (average OR 0.96, 95% CI 0.89 to 1.03; studies = 15; Heterogeneity: Tau² = 0.01; I² = 45%; moderate quality evidence) or low birthweight (average OR 0.94, 95% CI 0.82 to 1.06; studies = five; Heterogeneity: Tau² = 0.00; I² = 5%; high quality evidence). Single interventions led to marginal improvements in the number of women who delivered in health facilities (average OR 1.08, 95% CI 1.02 to 1.15; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; high quality evidence), and in the proportion of women who had at least one ANC visit (average OR 1.68, 95% CI 1.02 to 2.79; studies = six; Heterogeneity: Tau² = 0.24; I² = 76%; moderate quality evidence). Results for ANC coverage (at least four and at least one visit) and for perinatal mortality had substantial statistical heterogeneity. Single interventions did not improve the proportion of women receiving tetanus protection (average OR 1.03, 95% CI 0.92 to 1.15; studies = 8; Heterogeneity: Tau² = 0.01; I² = 57%). No study reported onintermittent prophylactic treatment for malaria.\nComparison 2: Two or more interventions versus no intervention\nWe found no improvements in ANC coverage of four or more visits (average OR 1.48, 95% CI 0.99 to 2.21; participants = 7840; studies = six; Heterogeneity: Tau² = 0.10; I² = 48%; low quality evidence) or pregnancy-related deaths (average OR 0.70, 95% CI 0.39 to 1.26; participants = 13,756; studies = three; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). However, combined interventions led to improvements in ANC coverage of at least one visit (average OR 1.79, 95% CI 1.47 to 2.17; studies = five; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence), perinatal mortality (average OR 0.74, 95% CI 0.57 to 0.95; studies = five; Heterogeneity: Tau² = 0.06; I² = 83%; moderate quality evidence) and low birthweight (average OR 0.61, 95% CI 0.46 to 0.80; studies = two; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). Meta-analyses for both ANC coverage four or more visits and perinatal mortality had substantial statistical heterogeneity. Combined interventions improved the proportion of women who had tetanus protection (average OR 1.48, 95% CI 1.18 to 1.87; studies = 3; Heterogeneity: Tau² = 0.01; I² = 33%). No trial in this comparison reported on intermittent prophylactic treatment for malaria.\nComparison 3: Two interventions compared head to head. No trials found.\nComparison 4: One intervention versus a combination of interventions\nThere was no difference in ANC coverage (four or more visits and at least one visit), pregnancy-related deaths, deliveries in a health facility or perinatal mortality. No trials in this comparison reported on low birthweight orintermittent prophylactic treatment of malaria.\nAuthors' conclusions\nImplications for practice - Single interventions may improve ANC coverage (at least one visit and four or more visits) and deliveries in health facilities. Combined interventions may improve ANC coverage (at least one visit), reduce perinatal mortality and reduce the occurrence of low birthweight. The effects of the interventions are unrelated to whether they are community or health system interventions.\nImplications for research - More details should be provided in reporting numbers of events, group totals and the ICCs used to adjust for cluster effects. Outcomes should be reported uniformly so that they are comparable to commonly-used population indicators. We recommend further cluster-RCTs of pregnant women and women in their reproductive years, using combinations of interventions and looking at outcomes that are important to pregnant women, such as maternal and perinatal morbidity and mortality, alongside the explanatory outcomes along the pathway of care: ANC coverage, the services provided during ANC and deliveries in health facilities.\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"
},
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"role": "assistant",
"content": "Single interventions may improve antenatal care coverage (women attending at least one visit and women attending four or more visits) and encourage women to give birth to their babies in health facilities. Combined interventions may also improve antenatal care coverage (at least one visit), reduce baby deaths and reduce the number of babies born with low birthweight.\nWe recommend that further studies of pregnant women and women in their reproductive years use combinations of interventions to maximise impact and look at outcomes that are important to the women themselves, such as maternal and baby deaths or ill health and the use of healthcare services."
}
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query-laysum | 2489 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis (TB) is an important cause of illness and death in HIV-positive children living in areas of high TB prevalence. We know that isoniazid prophylaxis prevents TB in HIV-negative children following TB exposure, but there is uncertainty related to its role in TB preventive treatment in HIV-positive children.\nObjectives\nTo summarise the effects of TB preventive treatment versus placebo in HIV-positive children with no known TB contact on active TB, death, and reported adverse events.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, Embase and two trial registers up to February 2017.\nSelection criteria\nWe included trials of HIV-positive children with and without known TB exposure, randomized to receive TB preventive treatment or placebo.\nData collection and analysis\nTwo review authors independently used the study selection criteria, assessed risk of bias, and extracted data. We assessed effects using risk, incidence rate and hazard ratios and assessed the certainty of evidence using GRADE.\nMain results\nWe included three trials, involving 991 participants, below the age of 13 years, from South Africa and Botswana. Children were randomized to isoniazid prophylaxis or placebo, given daily or three times weekly. The median length of follow-up ranged from 5.7 to 34 months; some were on antiretroviral therapy (ART).\nIn HIV-positive children not on ART, isoniazid prophylaxis may reduce the risk of active TB (hazard ratio (HR) 0.31, 95% confidence interval (CI) 0.11 to 0.87; 1 trial, 240 participants, low certainty evidence), and death (HR 0.46, 95% CI 0.22 to 0.95; 1 trial, 240 participants, low certainty evidence). One trial (182 participants) reported number of children with laboratory adverse events, which was similar between the isoniazid prophylaxis and placebo groups. No clinical adverse events were reported.\nIn HIV-positive children on ART, we do not know if isoniazid prophylaxis reduces the risk of active TB (risk ratio (RR) 0.76, 95% CI 0.50 to 1.14; 3 trials, 737 participants, very low certainty evidence) or death (RR 1.45, 95% CI 0.78 to 2.72; 3 trials, 737 participants, very low certainty evidence). Two trials (714 participants) reported number of clinical adverse events and three trials (795 participants) reported number of laboratory adverse events; for both categories, the number of adverse events were similar between the isoniazid prophylaxis and placebo groups.\nAuthors' conclusions\nIsoniazid prophylaxis given to all children diagnosed with HIV may reduce the risk of active TB and death in HIV-positive children not on ART in studies from Africa. For children on ART, no clear benefit was detected. .\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 areas of high tuberculosis endemicity, isoniazid prophylaxis prevents active TB and death in HIV-positive children who are not on ART.\nWe conducted a review to assess the effect of TB medication on active TB or death and its safety in HIV-positive children."
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query-laysum | 2490 | [
{
"role": "user",
"content": "Abstract: Background\nNitric oxide (NO) has multiple effects that may be beneficial in acute stroke, including lowering blood pressure, and promoting reperfusion and cytoprotection. Some forms of nitric oxide synthase inhibition (NOS-I) may also be beneficial. However, high concentrations of NO are likely to be toxic to brain tissue. This is an update of a Cochrane review first published in 1998, and last updated in 2002.\nObjectives\nTo assess the safety and efficacy of NO donors, L-arginine, and NOS-I in people with acute stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched 6 February 2017), MEDLINE (1966 to June 2016), Embase (1980 to June 2016), ISI Science Citation Indexes (1981 to June 2016), Stroke Trials Registry (searched June 2016), International Standard Randomised Controlled Trial Number (ISRCTN) (searched June 2016), Clinical Trials registry (searched June 2016), and International Clinical Trials Registry Platform (ICTRP) (searched June 2016). Previously, we had contacted drug companies and researchers in the field.\nSelection criteria\nRandomised controlled trials comparing nitric oxide donors, L-arginine, or NOS-I versus placebo or open control in people within one week of onset of confirmed stroke.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data. The review authors cross-checked data and resolved issues through discussion. We obtained published and unpublished data, as available. Data were reported as mean difference (MD) or odds ratio (OR) with 95% confidence intervals (CI).\nMain results\nWe included five completed trials, involving 4197 participants; all tested transdermal glyceryl trinitrate (GTN), an NO donor. The assessed risk of bias was low across the included studies; one study was double-blind, one open-label and three were single-blind. All included studies had blinded outcome assessment. Overall, GTN did not improve the primary outcome of death or dependency at the end of trial (modified Rankin Scale (mRS) > 2, OR 0.97, 95% CI 0.86 to 1.10, 4195 participants, high-quality evidence). GTN did not improve secondary outcomes, including death (OR 0.78, 95% CI 0.40 to 1.50) and quality of life (MD -0.01, 95% CI -0.17 to 0.15) at the end of trial overall (high-quality evidence). Systolic/diastolic blood pressure (BP) was lower in people treated with GTN (MD -7.2 mmHg (95% CI -8.6 to -5.9) and MD -3.3 (95% CI -4.2 to -2.5) respectively) and heart rate was higher (MD 2.0 beats per minute (95% CI 1.1 to 2.9)). Headache was more common in those randomised to GTN (OR 2.37, 95% CI 1.55 to 3.62). We did not find any trials assessing other nitrates, L-arginine, or NOS-I.\nAuthors' conclusions\nThere is currently insufficient evidence to recommend the use of NO donors, L-arginine or NOS-I in acute stroke, and only one drug (GTN) has been assessed. In people with acute stroke, GTN reduces blood pressure, increases heart rate and headache, but does not alter clinical outcome (all based on high-quality evidence).\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"
},
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"role": "assistant",
"content": "The key results are based on high-quality evidence."
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query-laysum | 2491 | [
{
"role": "user",
"content": "Abstract: Background\nCurrently, little evidence is available on the length and type of anticoagulation used for extended treatment for prevention of recurrent venous thromboembolism (VTE) in patients with unprovoked VTE who have completed initial oral anticoagulation therapy.\nObjectives\nTo compare the efficacy and safety of available oral therapeutic options (aspirin, warfarin, direct oral anticoagulants (DOACs)) for extended thromboprophylaxis in adults with a first unprovoked VTE, to prevent VTE recurrence after completion of an acceptable initial oral anticoagulant treatment period, as defined in individual studies.\nSearch methods\nFor this review, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (March 2017) as well as the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2). We also searched trials registries (March 2017) and reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials in which patients with a first, symptomatic, objectively confirmed, unprovoked VTE, who had been initially treated with anticoagulants, were randomised to extended prophylaxis (vitamin K antagonists (VKAs), antiplatelet agents, or DOACs) versus no prophylaxis or placebo. We also included trials that compared one type of extended prophylaxis versus another type of extended prophylaxis.\nData collection and analysis\nTwo review authors independently selected studies, assessed quality, and extracted data. We resolved disagreements by discussion.\nMain results\nSix studies with a combined total of 3436 participants met the inclusion criteria. Five studies compared extended prophylaxis versus placebo: three compared warfarin versus placebo, and two compared aspirin versus placebo. One study compared one type of extended prophylaxis (rivaroxaban) versus another type of extended prophylaxis (aspirin). For extended prophylaxis versus placebo, we downgraded the quality of the evidence for recurrent VTE and all-cause mortality to moderate owing to concerns arising from risks of selection and performance bias in individual studies. For all other outcomes in this review, we downgraded the quality of the evidence to low owing to concerns arising from risk of bias for the studies stated above, combined with concerns over imprecision. For extended prophylaxis versus other extended prophylaxis, we downgraded the quality of the evidence for recurrent VTE and major bleeding to moderate owing to concerns over imprecision. Risk of bias in the individual study was low.\nMeta-analysis showed that extended prophylaxis was no more effective than placebo in preventing VTE-related mortality (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.14 to 6.98; 1862 participants; 4 studies; P = 0.98; low-quality evidence), recurrent VTE (OR 0.63, 95% CI 0.38 to 1.03; 2043 participants; 5 studies; P = 0.07; moderate-quality evidence), major bleeding (OR 1.84, 95% CI 0.87 to 3.85; 2043 participants; 5 studies; P = 0.86; low-quality evidence), all-cause mortality (OR 1.00, 95% CI 0.63 to 1.57; 2043 participants; 5 studies; P = 0.99; moderate-quality evidence), clinically relevant non-major bleeding (OR 1.78, 95% CI 0.59 to 5.33; 1672 participants; 4 studies; P = 0.30; low-quality evidence), stroke (OR 1.15, 95% CI 0.39 to 3.46; 1224 participants; 2 studies; P = 0.80; low-quality evidence), or myocardial infarction (OR 1.00, 95% CI 0.35 to 2.87; 1495 participants; 3 studies; P = 1.00; low-quality evidence).\nOne study showed that the novel oral anticoagulant rivaroxaban was associated with fewer recurrent VTEs than aspirin (OR 0.28, 95% CI 0.15 to 0.54; 1389 participants; P = 0.0001; moderate-quality evidence). Data show no clear differences in the incidence of major bleeding between rivaroxaban and aspirin (OR 3.06, 95% CI 0.37 to 25.51; 1389 participants; P = 0.30; moderate-quality evidence) nor in the incidence of clinically relevant non-major bleeding (OR 0.84, 95% CI 0.37 to 1.94; 1389 participants; 1 study; P = 0.69; moderate-quality evidence). Data on VTE-related mortality, all-cause mortality, stroke, and myocardial infarction were not yet available for participants with unprovoked VTE and will be incorporated in future versions of the review.\nAuthors' conclusions\nEvidence is currently insufficient to permit definitive conclusions concerning the effectiveness and safety of extended thromboprophylaxis in prevention of recurrent VTE after initial oral anticoagulation therapy among participants with unprovoked VTE. Additional good-quality large-scale randomised controlled trials are required before firm conclusions can be reached.\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"
},
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"role": "assistant",
"content": "The quality of the evidence provided by studies included in this review ranged from low to moderate because a small number of studies with few events were included.\nThis review found that trials are too few to show whether extended treatment is safe and effective in preventing further blood clots after three months' treatment. Further good-quality and large-scale studies are required."
}
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query-laysum | 2492 | [
{
"role": "user",
"content": "Abstract: Background\nEmbryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for quality assessment by an embryologist, under a microscope. In recent years time-lapse systems (TLS) have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of embryo selection software, to assess the quality of the embryos without physically removing them from the incubator.\nThe potential advantages of a TLS include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature, and movement. A TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through continuously monitoring embryo development. Use of a TLS often adds significant extra cost to ART treatment.\nObjectives\nTo determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART.\nSearch methods\nWe used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, and two trials registers on 7 January 2019 and checked references of appropriate papers.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing TLS, with or without embryo selection software, versus conventional incubation with morphological assessment; and TLS with embryo selection software versus TLS without embryo selection software among couples undergoing ART.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth or ongoing pregnancy, miscarriage and stillbirth, and cumulative live birth or ongoing pregnancy rate. The secondary outcomes were clinical pregnancy and cumulative clinical pregnancy. We assessed the quality of the evidence using GRADE methodology. We made the following comparisons.\nTLS with conventional morphological assessment of still TLS images versus conventional incubation and assessment\nTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images\nTLS utilising embryo selection software versus conventional incubation and assessment\nMain results\nWe included nine RCTs (N = 2955 infertile couples). The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency. There were no data on cumulative live birth or ongoing pregnancy rate or cumulative clinical pregnancy rate.\nTLS with conventional morphological assessment of still TLS images versus conventional incubation and assessment\nIt is unclear whether there is any difference between interventions in rates of live birth or ongoing pregnancy (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.67 to 1.23, 3 RCTs, N = 826, I2 = 33%, low-quality evidence) or in miscarriage rates (OR 1.90, 95% CI 0.99 to 3.61, 3 RCTs, N = 826, I2 = 0%, low-quality evidence). The evidence suggests that if the rate of live birth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with the use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between the interventions in rates of stillbirth (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence) or clinical pregnancy (OR 1.06, 95% CI 0.79 to 1.41, 4 RCTs, N = 875, I2 = 0%, low-quality evidence).\nTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images\nAll findings for this comparison were very uncertain due to the very low-quality of the evidence. No data were available on live birth, but one RCT reported ongoing pregnancy. It is unclear whether there is any difference between the interventions in rates of ongoing pregnancy (OR 0.61, 95% CI 0.32 to 1.20, 1 RCT, N = 163); miscarriage (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I2 = 0%); or clinical pregnancy (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I2 = 0%). The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth.\nTLS utilising embryo selection software versus conventional incubation and assessment\nThe findings for this comparison were also very uncertain due to the very low quality of the evidence. It is unclear whether there is any difference between the interventions in rates of live birth (OR 1.12, 95% CI 0.92 to 1.36, 3 RCTs, N = 1617, I2 = 84%). There was very low-quality evidence that TLS might reduce miscarriage rates (OR 0.63, 95% CI 0.45 to 0.89, 3 RCTs, N = 1617, I2 = 0%). It is unclear whether there is any difference between the interventions in rates of clinical pregnancy (OR 0.95, 95% CI 0.78 to 1.16, 3 RCTs, N = 1617, I2 = 89%). The evidence suggests that if the rate of live birth associated with conventional incubation and assessment is 48%, the rate with TLS utilising embryo selection software would be between 46% and 55%, and if the miscarriage rate with conventional incubation and assessment is 11%, the rate associated with TLS would be between 5% and 10%. No stillbirths occurred in the only study reporting this outcome.\nAuthors' conclusions\nThere is insufficient good-quality evidence of differences in live birth or ongoing pregnancy, miscarriage and stillbirth, or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. As the evidence is of low or very low-quality, our findings should be interpreted with caution.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to January 2019. We included nine studies (randomised controlled trials, that is studies in which participants are assigned to one of two or more treatment groups using a random method) of 2955 infertile couples undergoing IVF or ICSI. There were three different study designs: (1) TLS with conventional assessment of still TLS images versus conventional incubation and assessment; (2) TLS utilising embryo selection software versus TLS with conventional assessment of still TLS images; and (3) TLS utilising embryo selection software versus conventional incubation and assessment."
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query-laysum | 2493 | [
{
"role": "user",
"content": "Abstract: Background\nFalls in care facilities and hospitals are common events that cause considerable morbidity and mortality for older people. This is an update of a review first published in 2010 and updated in 2012.\nObjectives\nTo assess the effects of interventions designed to reduce the incidence of falls in older people in care facilities and hospitals.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (August 2017); Cochrane Central Register of Controlled Trials (2017, Issue 8); and MEDLINE, Embase, CINAHL and trial registers to August 2017.\nSelection criteria\nRandomised controlled trials of interventions for preventing falls in older people in residential or nursing care facilities, or hospitals.\nData collection and analysis\nOne review author screened abstracts; two review authors screened full-text articles for inclusion. Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction. We calculated rate ratios (RaR) with 95% confidence intervals (CIs) for rate of falls and risk ratios (RRs) and 95% CIs for outcomes such as risk of falling (number of people falling). We pooled results where appropriate. We used GRADE to assess the quality of evidence.\nMain results\nThirty-five new trials (77,869 participants) were included in this update. Overall, we included 95 trials (138,164 participants), 71 (40,374 participants; mean age 84 years; 75% women) in care facilities and 24 (97,790 participants; mean age 78 years; 52% women) in hospitals. The majority of trials were at high risk of bias in one or more domains, mostly relating to lack of blinding. With few exceptions, the quality of evidence for individual interventions in either setting was generally rated as low or very low. Risk of fracture and adverse events were generally poorly reported and, where reported, the evidence was very low-quality, which means that we are uncertain of the estimates. Only the falls outcomes for the main comparisons are reported here.\nCare facilities\nSeventeen trials compared exercise with control (typically usual care alone). We are uncertain of the effect of exercise on rate of falls (RaR 0.93, 95% CI 0.72 to 1.20; 2002 participants, 10 studies; I² = 76%; very low-quality evidence). Exercise may make little or no difference to the risk of falling (RR 1.02, 95% CI 0.88 to 1.18; 2090 participants, 10 studies; I² = 23%; low-quality evidence).\nThere is low-quality evidence that general medication review (tested in 12 trials) may make little or no difference to the rate of falls (RaR 0.93, 95% CI 0.64 to 1.35; 2409 participants, 6 studies; I² = 93%) or the risk of falling (RR 0.93, 95% CI 0.80 to 1.09; 5139 participants, 6 studies; I² = 48%).\nThere is moderate-quality evidence that vitamin D supplementation (4512 participants, 4 studies) probably reduces the rate of falls (RaR 0.72, 95% CI 0.55 to 0.95; I² = 62%), but probably makes little or no difference to the risk of falling (RR 0.92, 95% CI 0.76 to 1.12; I² = 42%). The population included in these studies had low vitamin D levels.\nMultifactorial interventions were tested in 13 trials. We are uncertain of the effect of multifactorial interventions on the rate of falls (RaR 0.88, 95% CI 0.66 to 1.18; 3439 participants, 10 studies; I² = 84%; very low-quality evidence). They may make little or no difference to the risk of falling (RR 0.92, 95% CI 0.81 to 1.05; 3153 participants, 9 studies; I² = 42%; low-quality evidence).\nHospitals\nThree trials tested the effect of additional physiotherapy (supervised exercises) in rehabilitation wards (subacute setting). The very low-quality evidence means we are uncertain of the effect of additional physiotherapy on the rate of falls (RaR 0.59, 95% CI 0.26 to 1.34; 215 participants, 2 studies; I² = 0%), or whether it reduces the risk of falling (RR 0.36, 95% CI 0.14 to 0.93; 83 participants, 2 studies; I² = 0%).\nWe are uncertain of the effects of bed and chair sensor alarms in hospitals, tested in two trials (28,649 participants) on rate of falls (RaR 0.60, 95% CI 0.27 to 1.34; I² = 0%; very low-quality evidence) or risk of falling (RR 0.93, 95% CI 0.38 to 2.24; I² = 0%; very low-quality evidence).\nMultifactorial interventions in hospitals may reduce rate of falls in hospitals (RaR 0.80, 95% CI 0.64 to 1.01; 44,664 participants, 5 studies; I² = 52%). A subgroup analysis by setting suggests the reduction may be more likely in a subacute setting (RaR 0.67, 95% CI 0.54 to 0.83; 3747 participants, 2 studies; I² = 0%; low-quality evidence). We are uncertain of the effect of multifactorial interventions on the risk of falling (RR 0.82, 95% CI 0.62 to 1.09; 39,889 participants; 3 studies; I² = 0%; very low-quality evidence).\nAuthors' conclusions\nIn care facilities: we are uncertain of the effect of exercise on rate of falls and it may make little or no difference to the risk of falling. General medication review may make little or no difference to the rate of falls or risk of falling. Vitamin D supplementation probably reduces the rate of falls but not risk of falling. We are uncertain of the effect of multifactorial interventions on the rate of falls; they may make little or no difference to the risk of falling.\nIn hospitals: we are uncertain of the effect of additional physiotherapy on the rate of falls or whether it reduces the risk of falling. We are uncertain of the effect of providing bed sensor alarms on the rate of falls or risk of falling. Multifactorial interventions may reduce rate of falls, although subgroup analysis suggests this may apply mostly to a subacute setting; we are uncertain of the effect of these interventions on risk of falling.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Falls by older people in care facilities, such as nursing homes, and hospitals are common events that may cause loss of independence, injuries, and sometimes death as a result of injury. Effective interventions to prevent falls are therefore important. Many types of interventions are in use. These include exercise, medication interventions that include vitamin D supplementation and reviews of the drugs that people are taking, environment or assistive technologies including bed or chair alarms or the use of special (low/low) beds, social environment interventions that target staff members and changes in the organisational system, and knowledge interventions. A special type of intervention is the multifactorial intervention, where the selection of single interventions such as exercise and vitamin D supplementation is based on an assessment of a person's risk factors for falling. Falls are reported in two ways in our review. One outcome is rate of falls, which is the number of falls. The other outcome is risk of falling, which is the number of people who had one or more falls."
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query-laysum | 2494 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough lifestyle interventions are often recommended in the management of chronic gout, the evidence from trial data of the benefits and safety of using lifestyle interventions for treating acute gout attacks have not previously been examined in a systematic review.\nObjectives\nThe objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with acute gout.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE for studies (up to 5 April 2013). We also searched the 2010 to 2011 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) abstracts and performed a handsearch of the reference lists of included articles.\nSelection criteria\nStudies were included if they were randomised or quasi-randomised controlled trials which compared lifestyle interventions to another therapy (active or placebo) in patients with acute gout. Outcomes of interest were the change in participant-reported pain in the target joint(s), target joint inflammation and function, health-related quality of life (HRQoL), patient global assessment, study participant withdrawals due to adverse events (AEs) and serious adverse events (SAEs).\nData collection and analysis\nTwo review authors independently applied methods recommended by The Cochrane Collaboration for the selection, appraisal, data collection and synthesis of studies. We assessed the quality of the body of evidence for each outcome using the GRADE approach.\nMain results\nOnly one study (19 participants) at high risk of bias was included in the review. Patients were randomised to receive oral prednisolone and colchicine with or without concomitant topical ice therapy. Topical ice therapy provided significant additional benefit over oral prednisolone and colchicine alone with respect to pain, but did not significantly reduce swelling during acute gout episodes. Mean pain reduction with standard medical treatment was 4.4 cm on a 0 to 10 cm visual analogue scale (VAS) after one week; the addition of topical ice reduced pain by an additional 3.33 cm (95% CI 5.84 to 0.82), or an absolute reduction of 33% (8% to 58% reduction). Joint swelling was reduced by a mean of 3.8 cm in the standard medical treatment group; the addition of topical ice therapy did not reduce swelling significantly (mean difference (MD) 2.07 cm, 95% CI -1.56 to 5.70). Target joint function, HRQoL, patient global assessment, study participant withdrawals due to AEs and SEAs were not reported in this study.\nAuthors' conclusions\nThere is low quality evidence, from a single trial at high risk of bias, that the addition of topical ice therapy to oral prednisolone and colchicine for oligoarticular attacks of acute gout results in significantly greater pain reduction at one week.\n\nGiven the provided abstract, please respond to the following query: \"What is gout and what are lifestyle interventions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Gout is a very common cause of painful joint inflammation (arthritis) and is caused by urate crystals forming either within or around joints. The inflammation can lead to pain, redness, warmth and swelling of the affected joints, making the area difficult to touch or move. Some of the reasons why people get gout include their genetic make-up, being overweight, ingesting certain medications (for example cyclosporine), having impaired kidney function, and lifestyle habits such as drinking excessive amounts of alcohol and sugar-sweetened drinks.\nMedications are the mainstay of acute gout treatment. Given the recognised association between certain lifestyle risk factors and gout development, lifestyle changes such as consuming more water, coffee, dairy milk and cherry juice, and having fewer sugar-sweetened drinks, alcoholic beverages, meat and seafood are commonly recommended to people with chronic gout to prevent recurrence of attacks."
}
]
|
query-laysum | 2495 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures.\nObjectives\nTo evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age.\nSearch methods\nWe searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts.\nSelection criteria\nRandomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery.\nData collection and analysis\nThree review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.\nMain results\nWe included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding.\nNo studies reported our primary outcomes of pelvic pain and live birth rate.\nOxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs)\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence).\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence).\nNo studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate.\nExpanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs)\nWe are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose.\nNo studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate.\nCollagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT)\nEvidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence).\nOne study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups.\nNo studies reported results regarding pelvic pain or live birth rate.\nIn total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported.\nAuthors' conclusions\nWe found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes.\nIt is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence.\nNo adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 19 randomised controlled trials (RCTs) that included a total of 1316 women undergoing gynaecological surgery. These trials assessed different types of barrier agents for preventing adhesions and compared them with each other or with no treatment. The data are current to August 2019. Thirteen RCTs reported commercial funding; the other studies did not state their source of funding."
}
]
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query-laysum | 2496 | [
{
"role": "user",
"content": "Abstract: Background\nChronic abdominal pain is one of the major symptoms in people with chronic pancreatitis. The role of pregabalin in people with chronic pancreatic pain due to chronic pancreatitis is uncertain.\nObjectives\nTo assess the benefits and harms of pregabalin in people with chronic abdominal pain due to chronic pancreatitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2015, issue 6, and MEDLINE, EMBASE, Science Citation Index Expanded, trials registers until June 2015. We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only randomised controlled trials (RCT) performed in people with chronic pancreatic pain due to chronic pancreatitis, irrespective of language, blinding, or publication status for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and independently extracted data. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) with RevMan 5, based on intention-to-treat analysis.\nMain results\nOnly one study, funded by Pfizer, met the inclusion criteria for the review. A total of 64 participants (with chronic pain due to chronic pancreatitis) were randomly assigned to receive escalating doses of pregabalin (150 mg per day to 600 mg per day; 34 participants) or matching placebo (30 participants). Participants received pregabalin or placebo for three weeks on an outpatient basis; the outcomes were measured at the end of the treatment (i.e. three weeks from commencement of treatment). Potential participants taking concomitant analgesic medication and expected to stay on a stable regime during the trial were allowed to enter the study. This trial was at low risk of bias. The overall quality of evidence was low or moderate.\nOnly the short-term outcomes were available in this trial. The medium and long-term outcomes, number of work days lost, and length of hospital stay due to admissions for pain control were not available. This trial found that the changes in opiate use (MD -26.00 mg; 95% CI -47.36 to -4.64; participants = 64; moderate-quality evidence), and pain score percentage changes from baseline (MD -12.00; 95% CI -21.82 to -2.18; participants = 64; moderate-quality evidence) were better in participants taking pregabalin compared to those taking placebo. This trial also found that there were more adverse events in participants taking pregabalin compared to those taking placebo (RR 1.71; 95% CI 1.20 to 2.43; participants = 64). The differences between pregabalin and placebo were imprecise for short-term health-related quality of life measured with the EORTC CLQ-30 questionnaire (MD 11.40; 95% CI -3.28 to 26.08; participants = 64; moderate-quality evidence), proportion of people with serious adverse events (RR 1.76; 95% CI 0.35 to 8.96; participants = 64; low-quality evidence), and proportion of people requiring hospital admissions (RR 0.44; 95% CI 0.04 to 4.62; participants = 64; low quality evidence).\nAuthors' conclusions\nBased on low- to moderate-quality evidence, short-term use of pregabalin decreases short-term opiate use, and short-term pain scores, but increases the adverse events compared to placebo, in people with chronic pain due to chronic pancreatitis. The clinical implication of the decreases in short-term opiate use and short-term pain scores is not known.\nFuture trials assessing the role of pregabalin in decreasing chronic pain in chronic pancreatitis should assess the medium- or long-term effects of pregabalin and should include outcomes such as, quality of life, treatment-related adverse events, number of work days lost, number of hospital admissions, and the length of hospital stay, in addition to pain scores, to assess the clinical and socioeconomic impact.\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": "Is pregabalin useful in decreasing abdominal pain in people with chronic pancreatitis?"
}
]
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query-laysum | 2497 | [
{
"role": "user",
"content": "Abstract: Background\nPerioperative fluid strategies influence clinical outcomes following major surgery. Many intravenous fluid preparations are based on simple solutions, such as normal saline, that feature an electrolyte composition that differs from that of physiological plasma. Buffered fluids have a theoretical advantage of containing a substrate that acts to maintain the body’s acid-base status - typically a bicarbonate or a bicarbonate precursor such as maleate, gluconate, lactate, or acetate. Buffered fluids also provide additional electrolytes, including potassium, magnesium, and calcium, more closely matching the electrolyte balance of plasma. The putative benefits of buffered fluids have been compared with those of non-buffered fluids in the context of clinical studies conducted during the perioperative period. This review was published in 2012, and was updated in 2017.\nObjectives\nTo review effects of perioperative intravenous administration of buffered versus non-buffered fluids for plasma volume expansion or maintenance, or both, on clinical outcomes in adults undergoing all types of surgery.\nSearch methods\nWe electronically searched the Clinicaltrials.gov major trials registry, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 6) in the Cochrane Library, MEDLINE (1966 to June 2016), Embase (1980 to June 2016), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to June 2016). We handsearched conference abstracts and, when possible, contacted leaders in the field. We reran the search in May 2017. We added one potential new study of interest to the list of ‘Studies awaiting classification' and will incorporate this trial into formal review findings when we prepare the review update.\nSelection criteria\nOnly randomized controlled trials that compared buffered versus non-buffered intravenous fluids for surgical patients were eligible for inclusion. We excluded other forms of comparison such as crystalloids versus colloids and colloids versus different colloids.\nData collection and analysis\nTwo review authors screened references for eligibility, extracted data, and assessed risks of bias. We resolved disagreements by discussion and consensus, in collaboration with a third review author. We contacted trial authors to request additional information when appropriate. We presented pooled estimates for dichotomous outcomes as odds ratios (ORs) and for continuous outcomes as mean differences (MDs), with 95% confidence intervals (CIs). We analysed data via Review Manager 5.3 using fixed-effect models, and when heterogeneity was high (I² > 40%), we used random-effects models.\nMain results\nThis review includes, in total, 19 publications of 18 randomized controlled trials with a total of 1096 participants. We incorporated five of those 19 studies (330 participants) after the June 2016 update. Outcome measures in the included studies were thematically similar, covering perioperative electrolyte status, renal function, and acid-base status; however, we found significant clinical and statistical heterogeneity among the included studies. We identified variable protocols for fluid administration and total volumes of fluid administered to patients intraoperatively. Trial authors variably reported outcome data at disparate time points and with heterogeneous patient groups. Consequently, many outcome measures are reported in small group sizes, reducing overall confidence in effect size, despite relatively low inherent bias in the included studies. Several studies reported orphan outcome measures. We did not include in the results of this review one large, ongoing study of saline versus Ringer's solution.\nWe found insufficient evidence on effects of fluid therapies on mortality and postoperative organ dysfunction (defined as renal insufficiency leading to renal replacement therapy); confidence intervals were wide and included both clinically relevant benefit and harm: mortality (Peto OR 1.85, 95% CI 0.37 to 9.33; I² = 0%; 3 trials, 6 deaths, 276 participants; low-quality evidence); renal insufficiency (OR 0.82, 95% CI 0.34 to 1.98; I² = 0%; 4 trials, 22 events, 276 participants; low-quality evidence).\nWe noted several metabolic differences, including a difference in postoperative pH measured at end of surgery of 0.05 units - lower in the non-buffered fluid group (12 studies with a total of 720 participants; 95% CI 0.04 to 0.07; I² = 61%). However, this difference was not maintained on postoperative day one. We rated the quality of evidence for this outcome as moderate. We observed a higher postoperative serum chloride level immediately after operation, with use of non-buffered fluids reported in 10 studies with a total of 530 participants (MD 6.77 mmol/L, 95% CI 3.38 to 10.17), and this difference persisted until day one postoperatively (five studies with a total of 258 participants; MD 8.48 mmol/L, 95% CI 1.08 to 15.88). We rated the quality of evidence for this outcome as moderate.\nAuthors' conclusions\nCurrent evidence is insufficient to show effects of perioperative administration of buffered versus non-buffered crystalloid fluids on mortality and organ system function in adult patients following surgery. Benefits of buffered fluid were measurable in biochemical terms, particularly a significant reduction in postoperative hyperchloraemia and metabolic acidosis. Small effect sizes for biochemical outcomes and lack of correlated clinical follow-up data mean that robust conclusions on major morbidity and mortality associated with buffered versus non-buffered perioperative fluid choices are still lacking. Larger studies are needed to assess these relevant clinical outcomes.\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 assessed the quality of evidence as generally moderate, although quality of evidence showing effects of fluid choice on kidney function was low because of the presence of other factors that could affect kidney function in these participants. Evidence shows wide variation in the types of surgery performed and in drivers for and volumes of fluid administered across trials. Reported outcomes varied a great deal between included trials, and some results were expressed in ways that did not allow their inclusion in our findings."
}
]
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query-laysum | 2498 | [
{
"role": "user",
"content": "Abstract: Background\nChronic cough (a cough lasting longer than four weeks) is a common problem internationally. Chronic cough has associated economic costs and is distressing to the child and to parents; ignoring cough may lead to delayed diagnosis and progression of serious underlying respiratory disease. Clinical guidelines have been shown to lead to efficient and effective patient care and can facilitate clinical decision making. Cough guidelines have been designed to facilitate the management of chronic cough. However, treatment recommendations vary, and specific clinical pathways for the treatment of chronic cough in children are important, as causes of and treatments for cough vary significantly from those in adults. Therefore, systematic evaluation of the use of evidence-based clinical pathways for the management of chronic cough in children would be beneficial for clinical practice and for patient care. Use of a management algorithm can improve clinical outcomes; such management guidelines can be found in the guidelines for cough provided by the American College of Chest Physicians (ACCP) and the British Thoracic Society (BTS).\nObjectives\nTo evaluate the effectiveness of using a clinical pathway in the management of children with chronic cough.\nSearch methods\nThe Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles were searched. The latest search was conducted in January 2014.\nSelection criteria\nAll randomised controlled trials of parallel-group design comparing use versus non-use of a clinical pathway for treatment of chronic cough in children (< 18 years of age).\nData collection and analysis\nResults of searches were reviewed against predetermined criteria for inclusion. Two review authors independently selected studies and performed data extraction in duplicate.\nMain results\nOne study was included in the review. This multi-centre trial was based in five Australian hospitals and recruited 272 children with chronic cough. Children were randomly assigned to early (two weeks) or delayed (six weeks) referral to respiratory specialists who used a cough management pathway. When an intention-to-treat analysis was performed, clinical failure at six weeks post randomisation (defined as < 75% improvement in cough score, or total resolution for fewer than three consecutive days) was significantly less in the early pathway arm compared with the control arm (odds ratio (OR) 0.35, 95% confidence interval (CI) 0.21 to 0.58). These results indicate that one additional child will be cured for every five children treated via the cough pathway (number needed to treat for an additional beneficial outcome (NNTB) = 5, 95% CI 3 to 9) at six weeks. Cough-specific parent-reported quality of life scores were significantly better in the early-pathway group; the mean difference (MD) between groups was 0.60 (95% CI 0.19 to 1.01). Duration of cough post randomisation was significantly shorter in the intervention group (early-pathway arm) compared with the control group (delayed-pathway arm) (MD -2.70 weeks, 95% CI -4.26 to -1.14).\nAuthors' conclusions\nCurrent evidence suggests that using a clinical algorithm for the management of children with chronic cough in hospital outpatient settings is more effective than providing wait-list care. Futher high-quality randomised controlled trials are needed to perform ongoing evaluation of cough management pathways in general practitioner and other primary care settings.\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": "Clinical pathways serve as a tool or algorithm (like a flow chart) that can be used in the treatment of patients with various chronic diseases. They provide a clear guide that assists doctors in diagnosing an illness and in making decisions with the patient about what treatment is needed or which specialists should be seen or tests ordered at each stage of progression of the disease. Overall the aim of clinical pathways is to provide efficient care for patients. Examples of patient decision aids are provided by the National Health Service (NHS) in the UK at http://www.rightcare.nhs.uk/index.php/shared-decision-making/about-the-pdas/.\nChronic cough in children is a significant medical problem that in some situations warrants thorough investigation. This review examined whether using clinical pathways was effective for evaluating and managing children with chronic cough (cough lasting longer than 4 weeks)."
}
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query-laysum | 2499 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable respiratory disease. COPD exacerbations are associated with worse quality of life, increased hospitalisations, and increased mortality. Currently available pharmacological interventions have variable impact on exacerbation frequency. The anti-inflammatory effects of statins may lead to decreased pulmonary and systemic inflammation, resulting in fewer exacerbations of COPD. Several observational studies have shown potential benefits of statins for patients with COPD.\nObjectives\nThis review aims to evaluate available evidence on benefits and harms associated with statin therapy compared with placebo as adjunct therapy for patients with COPD. Primary objectives include the following.\n• To determine whether statins reduce mortality rates in COPD.\n• To determine whether statins reduce exacerbation frequency, improve quality of life, or improve lung function in COPD.\n• To determine whether statins are associated with adverse effects.\nSearch methods\nWe identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted the most recent search on 20 May 2019.\nSelection criteria\nParallel, randomised controlled trials recruiting adults with COPD.\nData collection and analysis\nWe used standard methods as expected by Cochrane. Prespecified primary outcomes were number of exacerbations, all-cause mortality, and COPD-specific mortality.\nMain results\nEight studies including 1323 participants with COPD were included in the review. Participants had a mean age of 61.4 to 72 years, and most were male (median 73.4%). Mean baseline forced expiratory volume in one second (FEV₁) ranged from 41% to 90% predicted. All studies compared moderate- or high-intensity statin therapy versus placebo. The duration of treatment ranged from 12 weeks to 36 months.\nWe found no statistically significant difference between statins and placebo in our primary outcome of number of exacerbations per person-year (mean difference (MD) -0.03, 95% confidence interval (CI) -0.25 to 0.19, 1 trial, 877 participants), including number of exacerbations requiring hospitalisation per person-year (MD 0.00, 95% CI -0.10 to 0.10, 1 trial, 877 exacerbations). This evidence was of moderate quality after downgrading for unclear risk of bias. Our primary outcomes of all-cause mortality (odds ratio (OR) 1.03, 95% CI 0.61 to 1.74, 2 trials, 952 participants) and COPD-specific mortality (OR 1.25, 95% CI 0.38 to 4.13, 1 trial, 877 participants) showed no significant difference between statins and placebo, with wide confidence intervals suggesting uncertainty about the precision of the results. This evidence was of low quality after downgrading for unclear risk of bias and imprecision.\nResults of the secondary outcomes analysis showed no clear differences between statins and placebo for FEV₁ (% predicted) (MD 1.18, 95% CI -2.6 to 4.97, 6 trials, 325 participants) but did show a statistically significant improvement in FEV₁/forced vital capacity (FVC) (MD 2.66, 95% CI 0.12 to 5.2; P = 0.04; 6 trials, 325 participants). A sensitivity analysis excluding two trials at high risk of bias showed no statistically significant difference in FEV₁/FVC (MD 2.05, 95% CI -0.87 to -4.97; P = 0.17; 4 trials, 255 participants). We also found no significant differences between the two groups in functional capacity measured by six-minute walk distance in metres (MD 1.79, 95% CI -52.51 to 56.09, 3 trials, 71 participants), with wide confidence intervals suggesting uncertainty about the precision of the results. Results show no clear difference in quality of life, which was reported in three trials, and a slight reduction in C-reactive protein (CRP) in the intervention group, which was statistically significant (MD -1.03, 95% CI -1.95 to -0.11; I² = 0%, P = 0.03; 3 trials, 142 participants). We noted a significant reduction in interleukin (IL)-6 in the intervention group (MD -2.11, 95% CI -2.65 to -1.56; I² = 0%, P ≤ 0.00001; 2 trials, 125 participants). All trials mentioned adverse events and indicated that statins were generally well tolerated. One study reported adverse events in detail and indicated that rates of all non-fatal adverse events (the number of serious adverse events per person-year) were similar in both groups (0.63 ± 1.56 events (intervention group) and 0.62 ± 1.48 events (control group); P > 0.20) for all comparisons, except for non-fatal serious adverse events involving the gastrointestinal tract, which were more frequent in the intervention group (in 30 patients (0.05 events per person-year) vs 17 patients (0.02 events per person-year); P = 0.02). Another trial lists the total numbers and percentages of adverse events in the intervention group (12 (26%)) and in the control group (21 (43%)) and of serious adverse events in the intervention group (4 (9%)) and in the control group (3 (6%)).The other trials stated that researchers found no significant adverse effects of statins but did not report adverse events in detail.\nAuthors' conclusions\nA small number of trials providing low- or moderate-quality evidence were suitable for inclusion in this review. They showed that use of statins resulted in a reduction in CRP and IL-6, but that this did not translate into clear clinical benefit for people with COPD. Further randomised controlled trials are needed to explore this topic.\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 statins reduced the level of inflammation in people with COPD but that this did not result in any clear improvement in exacerbations, mortality, functional capacity, quality of life, or lung function. Statins were generally well tolerated and were associated with few adverse effects."
}
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query-laysum | 2500 | [
{
"role": "user",
"content": "Abstract: Background\nMedications with anticholinergic properties are commonly prescribed to older adults. The cumulative anticholinergic effect of all the medications a person takes is referred to as the 'anticholinergic burden' because of its potential to cause adverse effects. It is possible that high anticholinergic burden may be a risk factor for development of cognitive decline or dementia. There are various scales available to measure anticholinergic burden but agreement between them is often poor.\nObjectives\nTo assess whether anticholinergic burden, as defined at the level of each individual scale, is a prognostic factor for future cognitive decline or dementia in cognitively unimpaired older adults.\nSearch methods\nWe searched the following databases from inception to 24 March 2021: MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), and ISI Web of Science Core Collection (ISI Web of Science).\nSelection criteria\nWe included prospective and retrospective longitudinal cohort and case-control observational studies with a minimum of one year' follow-up that examined the association between an anticholinergic burden measurement scale and future cognitive decline or dementia in cognitively unimpaired older adults.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, and undertook data extraction, assessment of risk of bias, and GRADE assessment. We extracted odds ratios (OR) and hazard ratios, with 95% confidence intervals (CI), and linear data on the association between anticholinergic burden and cognitive decline or dementia. We intended to pool each metric separately; however, only OR-based data were suitable for pooling via a random-effects meta-analysis. We initially established adjusted and unadjusted pooled rates for each available anticholinergic scale; then, as an exploratory analysis, established pooled rates on the prespecified association across scales. We examined variability based on severity of anticholinergic burden.\nMain results\nWe identified 25 studies that met our inclusion criteria (968,428 older adults). Twenty studies were conducted in the community care setting, two in primary care clinics, and three in secondary care settings. Eight studies (320,906 participants) provided suitable data for meta-analysis. The Anticholinergic Cognitive Burden scale (ACB scale) was the only scale with sufficient data for 'scale-based' meta-analysis. Unadjusted ORs suggested an increased risk for cognitive decline or dementia in older adults with an anticholinergic burden (OR 1.47, 95% CI 1.09 to 1.96) and adjusted ORs similarly suggested an increased risk for anticholinergic burden, defined according to the ACB scale (OR 2.63, 95% CI 1.09 to 6.29). Exploratory analysis combining adjusted ORs across available scales supported these results (OR 2.16, 95% CI 1.38 to 3.38), and there was evidence of variability in risk based on severity of anticholinergic burden (ACB scale 1: OR 2.18, 95% CI 1.11 to 4.29; ACB scale 2: OR 2.71, 95% CI 2.01 to 3.56; ACB scale 3: OR 3.27, 95% CI 1.41 to 7.61); however, overall GRADE evaluation of certainty of the evidence was low.\nAuthors' conclusions\nThere is low-certainty evidence that older adults without cognitive impairment who take medications with anticholinergic effects may be at increased risk of cognitive decline or dementia.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Medicines can be classified by their ability to block the action of a chemical signalling system in the body called the cholinergic system. Medicines that do this are said to have anticholinergic effects. There are various measurement scales to quantify the effects of anticholinergic medicines. The overall anticholinergic effect caused by all the anticholinergic medications a person is taking is referred to as 'anticholinergic burden.'\nWe aimed to investigate if older people who have no problems with memory or thinking are more likely to develop dementia when prescribed anticholinergic medicines than people who are not prescribed these medicines.\nAnticholinergic burden ratings can vary with the scale used because different scales score medicines in different ways. Therefore, we also wanted to know if any particular anticholinergic burden measurement scale was more strongly associated with increased risk of dementia than other scales."
}
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query-laysum | 2501 | [
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective.\nObjectives\nTo assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults.\nSearch methods\nWe searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments.\nData collection and analysis\nTwo review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables.\nMain results\nWe included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants.\nTwo studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size.\nOnly one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous.\nThere were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.\nThere was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct.\nOne study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme.\nNo serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants.\nThe quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available.\nAuthors' conclusions\nThere was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.\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 transcutaneous electrical nerve stimulation (TENS) relieve pain in adults with fibromyalgia?"
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query-laysum | 2502 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is a multisystem disease; the importance of growth and nutritional status is well established given their implications for lung function and overall survivability. Furthermore, it has been established that intestinal microbial imbalance and inflammation are present in people with CF. Oral prebiotics are commercially available substrates that are selectively utilised by host intestinal micro-organisms and may improve both intestinal and overall health.\nObjectives\nTo evaluate the benefits and harms of prebiotics for improving health outcomes in children and adults with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. Date of last search: 19 October 2022.\nWe also searched PubMed and online trials registries. Date of last search: 13 January 2023.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the efficacy of prebiotics in children and adults with CF. We planned to only include the first treatment period from cross-over RCTs, regardless of washout period.\nData collection and analysis\nWe did not identify any relevant trials.\nMain results\nWe did not identify any relevant trials for inclusion in this review.\nAuthors' conclusions\nThis review did not find any evidence for the use of prebiotics in people with CF. Until such evidence is available, it is reasonable for clinicians to follow any local guidelines and to discuss the use of dietary prebiotics with their patients.\nLarge and robust RCTs assessing the dietary prebiotics of inulin or galacto-oligosaccharides or fructo-oligosaccharides, or any combination of these, are needed. Such studies should be of at least 12 months in duration and assess outcomes such as growth and nutrition, gastrointestinal symptoms, pulmonary exacerbations, lung function, inflammatory biomarkers, hospitalisations, intestinal microbial profiling, and faecal short-chain fatty acids. Trials should include both children and adults and aim to be adequately powered to allow for subgroup analysis by age.\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 comparing individual or multiple combinations of oral (swallowed) prebiotics compared to no treatment or a placebo (treatment with no active ingredient); a single different prebiotic or a combination of other prebiotics; or a probiotic or a symbiotic (a combination of prebiotics and probiotics). We did not restrict trials based on age or how ill or healthy people were with regard to their CF."
}
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query-laysum | 2503 | [
{
"role": "user",
"content": "Abstract: Background\nLower-limb running injuries are common. Running shoes have been proposed as one means of reducing injury risk. However, there is uncertainty as to how effective running shoes are for the prevention of injury. It is also unclear how the effects of different characteristics of running shoes prevent injury.\nObjectives\nTo assess the effects (benefits and harms) of running shoes for preventing lower-limb running injuries in adult runners.\nSearch methods\nWe searched the following databases: CENTRAL, MEDLINE, Embase, AMED, CINAHL Plus and SPORTDiscus plus trial registers WHO ICTRP and ClinicalTrials.gov. We also searched additional sources for published and unpublished trials. The date of the search was June 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs involving runners or military personnel in basic training that either compared a) a running shoe with a non-running shoe; b) different types of running shoes (minimalist, neutral/cushioned, motion control, stability, soft midsole, hard midsole); or c) footwear recommended and selected on foot posture versus footwear not recommended and not selected on foot posture for preventing lower-limb running injuries. Our primary outcomes were number of people sustaining a lower-limb running injury and number of lower-limb running injuries. Our secondary outcomes were number of runners who failed to return to running or their previous level of running, runner satisfaction with footwear, adverse events other than musculoskeletal injuries, and number of runners requiring hospital admission or surgery, or both, for musculoskeletal injury or adverse event.\nData collection and analysis\nTwo review authors independently assessed study eligibility and performed data extraction and risk of bias assessment. The certainty of the included evidence was assessed using GRADE methodology.\nMain results\nWe included 12 trials in the analysis which included a total of 11,240 participants, in trials that lasted from 6 to 26 weeks and were carried out in North America, Europe, Australia and South Africa. Most of the evidence was low or very low certainty as it was not possible to blind runners to their allocated running shoe, there was variation in the definition of an injury and characteristics of footwear, and there were too few studies for most comparisons.\nWe did not find any trials that compared running shoes with non-running shoes.\nNeutral/cushioned versus minimalist (5 studies, 766 participants)\nNeutral/cushioned shoes may make little or no difference to the number of runners sustaining a lower-limb running injuries when compared with minimalist shoes (low-certainty evidence) (risk ratio (RR) 0.77, 95% confidence interval (CI) 0.59 to 1.01).\nOne trial reported that 67% and 92% of runners were satisfied with their neutral/cushioned or minimalist running shoes, respectively (RR 0.73, 95% CI 0.47 to 1.12). Another trial reported mean satisfaction scores ranged from 4.0 to 4.3 in the neutral/ cushioned group and 3.6 to 3.9 in the minimalist running shoe group out of a total of 5. Hence neutral/cushioned running shoes may make little or no difference to runner satisfaction with footwear (low-certainty evidence).\nMotion control versus neutral / cushioned (2 studies, 421 participants)\nIt is uncertain whether or not motion control shoes reduce the number of runners sustaining a lower-limb running injuries when compared with neutral / cushioned shoes because the quality of the evidence has been assessed as very low certainty (RR 0.92, 95% CI 0.30 to 2.81).\nSoft midsole versus hard midsole (2 studies, 1095 participants)\nSoft midsole shoes may make little or no difference to the number of runners sustaining a lower-limb running injuries when compared with hard midsole shoes (low-certainty of evidence) (RR 0.82, 95% CI 0.61 to 1.10).\nStability versus neutral / cushioned (1 study, 57 participants)\nIt is uncertain whether or not stability shoes reduce the number of runners sustaining a lower-limb running injuries when compared with neutral/cushioned shoes because the quality of the evidence has been assessed as very low certainty (RR 0.49, 95% CI 0.18 to 1.31).\nMotion control versus stability (1 study, 56 participants)\nIt is uncertain whether or not motion control shoes reduce the number of runners sustaining a lower-limb running injuries when compared with stability shoes because the quality of the evidence has been assessed as very low certainty (RR 3.47, 95% CI 1.43 to 8.40).\nRunning shoes prescribed and selected on foot posture (3 studies, 7203 participants)\nThere was no evidence that running shoes prescribed based on static foot posture reduced the number of injuries compared with those who received a shoe not prescribed based on foot posture in military recruits (Rate Ratio 1.03, 95% CI 0.94 to 1.13). Subgroup analysis confirmed these findings were consistent between males and females. Therefore, prescribing running shoes and selecting on foot posture probably makes little or no difference to lower-limb running injuries (moderate-certainty evidence).\nData were not available for all other review outcomes.\nAuthors' conclusions\nMost evidence demonstrates no reduction in lower-limb running injuries in adults when comparing different types of running shoes. Overall, the certainty of the evidence determining whether different types of running shoes influence running injury rates was very low to low, and as such we are uncertain as to the true effects of different types of running shoes upon injury rates.\nThere is no evidence that prescribing footwear based on foot type reduces running-related lower-limb injures in adults. The evidence for this comparison was rated as moderate and as such we can have more certainty when interpreting these findings. However, all three trials included in this comparison used military populations and as such the findings may differ in recreational runners.\nFuture researchers should develop a consensus definition of running shoe design to help standardise classification. The definition of a running injury should also be used consistently and confirmed via health practitioners. More researchers should consider a RCT design to increase the evidence in this area. Lastly, future work should look to explore the influence of different types or running shoes upon injury rates in specific subgroups.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared running-injury rates (number of runners injured or total number of injuries) between groups of runners or military personnel who wore different types of running shoes.\nWe compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods."
}
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query-laysum | 2504 | [
{
"role": "user",
"content": "Abstract: Background\nInterventions by specialist breast cancer nurses (SBCNs) aim to support women and help them cope with the impact of the disease on their quality of life.\nObjectives\nTo assess the effects of individual interventions carried out by SBCNs on indicators of quality of life, anxiety, depression, and participant satisfaction.\nSearch methods\nIn June 2020, we searched MEDLINE, Embase, CENTRAL (Trials only), Cochrane Breast Cancer Group's Specialist Register (CBCG SR), CINAHL, PsycINFO, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and Clinicaltrials.gov.\nSelection criteria\nWe selected randomised controlled trials (RCTs) of interventions carried out by SBCNs for women with breast cancer, which reported indicators of quality of life, anxiety, depression, and participant satisfaction.\nData collection and analysis\nThe certainty of the evidence was evaluated using the GRADE approach. A narrative description of the results including structured tabulation was carried out.\nMain results\nWe included 14 RCTs involving 2905 women. With the exception of one study (women with advanced breast cancer), all the women were diagnosed with primary breast cancer. Mean age ranged from 48 to 64 years.\nPsychosocial nursing interventions compared with standard care for women with primary breast cancer\nEight studies (1328 women, low-quality evidence) showed small improvements in general health-related quality of life or no difference in effect between nine weeks and 18 months. Six studies (897 women, low-quality evidence) showed small improvements in cancer-specific quality of life or no difference in effect between nine weeks and 18 months. Six studies (951 women, low-quality evidence) showed small improvements in anxiety and depression between nine weeks and 18 months. Two studies (320 women, low-quality evidence) measured satisfaction during survivorship; one study measured satisfaction only in the intervention group and showed high levels of satisfaction with care; the second study showed equal satisfaction with care in both groups at six months.\nPsychosocial nursing interventions compared with other supportive care interventions for women with primary breast cancer\nTwo studies (351 women, very-low quality evidence) measured general health-related quality of life. One study reported that psychological morbidity reduced over the 12-month period; scores were consistently lower in women supported by SBCNs alone compared to support from a voluntary organisation. The other study reported that at six months, women receiving psychosocial support by either SBCNs or psychologists clinically improved from \"higher levels of distress\" to \"lower levels of distress\".\nOne study (179 women, very-low quality evidence) showed no between-group differences on subscales at all time points up to six months measured using cancer-specific quality of life questionnaires. There were significant group-by-time changes in the global quality of life, nausea and vomiting, and systemic therapy side effects subscales, for women receiving psychosocial support by either SBCNs or psychologists at six months. There were improvements in other subscales over time in both groups. Systemic therapy side effects increased significantly in the psychologist group but not in the SBCN group. Sexual functioning decreased in both groups.\nTwo studies (351 women, very-low quality evidence) measured anxiety and depression. One study reported that anxiety subscale scores and state anxiety scores improved over six months but there was no effect on depression subscale scores in the SBCN group compared to the psychologist group. There was no group-by-time interaction on the anxiety and depression or state anxiety subscales. The other study reported that anxiety and depression scores reduced over the 12-month post-surgery period in the SBCN group; scores were consistently lower in women supported by SBCNs compared to support from a voluntary organisation.\nSBCN-led telephone interventions delivering follow-up care compared with usual care for women with primary breast cancer\nThree studies (931 women, moderate-quality evidence) reported general health-related quality of life outcomes. Two studies reported no difference in psychological morbidity scores between SBCN-led follow-up care and standard care at 18 to 24 months. One trial reported no change in feelings of control scores between SBCN-led follow-up care and standard care at 12 months.\nTwo studies (557 women, moderate-quality evidence) reported no between-group difference in cancer-specific quality of life at 18 to 24 months. A SBCN intervention conducted by telephone, as a point-of-need access to specialist care, did not change psychological morbidity compared to routine clinical review at 18 months. Scores for both groups on the breast cancer subscale improved over time, with lower scores at nine and 18 months compared to baseline. The adjusted mean differences between groups at 18 months was 0.7 points in favour of the SBCN intervention (P = 0.058). A second study showed no differences between groups for role and emotional functioning measured using cancer-specific quality of life questionnaires in a SBCN-led telephone intervention compared with standard hospital care, both with and without an educational group programme at 12 months. At 12 months, mean scores were 78.4 (SD = 16.2) and 77.7 (SD = 16.2) respectively for SBCN-led telephone and standard hospital follow-up. The 95% confidence interval difference at 12 months was -1.93 to 4.64.\nThree studies (1094 women, moderate-quality evidence) reported no between-group difference in anxiety between 12 and 60 months follow-up. One of these studies also measured depression and reported no difference in depression scores between groups at five years (anxiety: RR 1.8; 95% CI 0.6 to 5.1; depression: RR 1.7 95% CI 0.4 to 7.2).\nFour studies (1331 women, moderate-quality evidence) demonstrated high levels of satisfaction with SBCN-led follow-up care by telephone between 12 and 60 months.\nPsychosocial nursing interventions compared with usual care for women with advanced breast cancer\nOne study (105 women, low-quality evidence) showed no difference in cancer-specific quality of life outcomes at 3 months.\nAuthors' conclusions\nEvidence suggests that psychosocial interventions delivered by SBCNs for women with primary breast cancer may improve or are at least as effective as standard care and other supportive interventions, during diagnosis, treatment and survivorship. SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.\n\nGiven the provided abstract, please respond to the following query: \"Psychosocial nursing interventions compared with standard care for women with advanced (metastatic) breast cancer\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was only one study which showed that there was no difference in quality of life outcomes at three months following a brief psychosocial nursing intervention compared with standard care for 105 women with newly diagnosed advanced breast cancer."
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query-laysum | 2505 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy (DR) is characterised by neurovascular degeneration as a result of chronic hyperglycaemia. Proliferative diabetic retinopathy (PDR) is the most serious complication of DR and can lead to total (central and peripheral) visual loss. PDR is characterised by the presence of abnormal new blood vessels, so-called “new vessels,” at the optic disc (NVD) or elsewhere in the retina (NVE). PDR can progress to high-risk characteristics (HRC) PDR (HRC-PDR), which is defined by the presence of NVD more than one-fourth to one-third disc area in size plus vitreous haemorrhage or pre-retinal haemorrhage, or vitreous haemorrhage or pre-retinal haemorrhage obscuring more than one disc area. In severe cases, fibrovascular membranes grow over the retinal surface and tractional retinal detachment with sight loss can occur, despite treatment. Although most, if not all, individuals with diabetes will develop DR if they live long enough, only some progress to the sight-threatening PDR stage.\nObjectives\nTo determine risk factors for the development of PDR and HRC-PDR in people with diabetes and DR.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5), Ovid MEDLINE, and Ovid Embase. The date of the search was 27 May 2022. Additionally, the search was supplemented by screening reference lists of eligible articles. There were no restrictions to language or year of publication.\nSelection criteria\nWe included prospective or retrospective cohort studies and case-control longitudinal studies evaluating prognostic factors for the development and progression of PDR, in people who have not had previous treatment for DR. The target population consisted of adults (≥18 years of age) of any gender, sexual orientation, ethnicity, socioeconomic status, and geographical location, with non-proliferative diabetic retinopathy (NPDR) or PDR with less than HRC-PDR, diagnosed as per standard clinical practice. Two review authors independently screened titles and abstracts, and full-text articles, to determine eligibility; discrepancies were resolved through discussion. We considered prognostic factors measured at baseline and any other time points during the study and in any clinical setting. Outcomes were evaluated at three and eight years (± two years) or lifelong.\nData collection and analysis\nTwo review authors independently extracted data from included studies using a data extraction form that we developed and piloted prior to the data collection stage. We resolved any discrepancies through discussion. We used the Quality in Prognosis Studies (QUIPS) tool to assess risk of bias. We conducted meta-analyses in clinically relevant groups using a random-effects approach. We reported hazard ratios (HR), odds ratios (OR), and risk ratios (RR) separately for each available prognostic factor and outcome, stratified by different time points. Where possible, we meta-analysed adjusted prognostic factors. We evaluated the certainty of the evidence with an adapted version of the GRADE framework.\nMain results\nWe screened 6391 records. From these, we identified 59 studies (87 articles) as eligible for inclusion. Thirty-five were prospective cohort studies, 22 were retrospective studies, 18 of which were cohort and six were based on data from electronic registers, and two were retrospective case-control studies. Twenty-three studies evaluated participants with type 1 diabetes (T1D), 19 with type 2 diabetes (T2D), and 17 included mixed populations (T1D and T2D). Studies on T1D included between 39 and 3250 participants at baseline, followed up for one to 45 years. Studies on T2D included between 100 and 71,817 participants at baseline, followed up for one to 20 years. The studies on mixed populations of T1D and T2D ranged from 76 to 32,553 participants at baseline, followed up for four to 25 years.\nWe found evidence indicating that higher glycated haemoglobin (haemoglobin A1c (HbA1c)) levels (adjusted OR ranged from 1.11 (95% confidence interval (CI) 0.93 to 1.32) to 2.10 (95% CI 1.64 to 2.69) and more advanced stages of retinopathy (adjusted OR ranged from 1.38 (95% CI 1.29 to 1.48) to 12.40 (95% CI 5.31 to 28.98) are independent risk factors for the development of PDR in people with T1D and T2D. We rated the evidence for these factors as of moderate certainty because of moderate to high risk of bias in the studies.\nThere was also some evidence suggesting several markers for renal disease (for example, nephropathy (adjusted OR ranged from 1.58 (95% CI not reported) to 2.68 (2.09 to 3.42), and creatinine (adjusted meta-analysis HR 1.61 (95% CI 0.77 to 3.36)), and, in people with T1D, age at diagnosis of diabetes (< 12 years of age) (standardised regression estimate 1.62, 95% CI 1.06 to 2.48), increased triglyceride levels (adjusted RR 1.55, 95% CI 1.06 to 1.95), and larger retinal venular diameters (RR 4.28, 95% CI 1.50 to 12.19) may increase the risk of progression to PDR. The certainty of evidence for these factors, however, was low to very low, due to risk of bias in the included studies, inconsistency (lack of studies preventing the grading of consistency or variable outcomes), and imprecision (wide CIs). There was no substantial and consistent evidence to support duration of diabetes, systolic or diastolic blood pressure, total cholesterol, low- (LDL) and high- (HDL) density lipoproteins, gender, ethnicity, body mass index (BMI), socioeconomic status, or tobacco and alcohol consumption as being associated with incidence of PDR. There was insufficient evidence to evaluate prognostic factors associated with progression of PDR to HRC-PDR.\nAuthors' conclusions\nIncreased HbA1c is likely to be associated with progression to PDR; therefore, maintaining adequate glucose control throughout life, irrespective of stage of DR severity, may help to prevent progression to PDR and risk of its sight-threatening complications. Renal impairment in people with T1D or T2D, as well as younger age at diagnosis of diabetes mellitus (DM), increased triglyceride levels, and increased retinal venular diameters in people with T1D may also be associated with increased risk of progression to PDR. Given that more advanced DR severity is associated with higher risk of progression to PDR, the earlier the disease is identified, and the above systemic risk factors are controlled, the greater the chance of reducing the risk of PDR and saving sight.\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"
},
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"role": "assistant",
"content": "We wanted to find out which factors may increase or reduce the chance that people with diabetes develop proliferative diabetic retinopathy and high-risk proliferative diabetic retinopathy, both sight-threatening complications of diabetes."
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query-laysum | 2506 | [
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"role": "user",
"content": "Abstract: Background\nWorldwide, many countries have adopted colorectal cancer (CRC) screening programmes, often based on faecal occult blood tests (FOBTs). CRC screening aims to detect advanced neoplasia (AN), which is defined as CRC or advanced adenomas. FOBTs fall into two categories based on detection technique and the detected blood component: qualitative guaiac-based FOBTs (gFOBTs) and faecal immunochemical tests (FITs), which can be qualitative and quantitative. Screening with gFOBTs reduces CRC-related mortality.\nObjectives\nTo compare the diagnostic test accuracy of gFOBT and FIT screening for detecting advanced colorectal neoplasia in average-risk individuals.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, BIOSIS Citation Index, Science Citation Index Expanded, and Google Scholar. We searched the reference lists and PubMed-related articles of included studies to identify additional studies.\nSelection criteria\nWe included prospective and retrospective studies that provided the number of true positives, false positives, false negatives, and true negatives for gFOBTs, FITs, or both, with colonoscopy as reference standard. We excluded case-control studies. We included studies in which all participants underwent both index test and reference standard (\"reference standard: all\"), and studies in which only participants with a positive index test underwent the reference standard while participants with a negative test were followed for at least one year for development of interval carcinomas (\"reference standard: positive\"). The target population consisted of asymptomatic, average-risk individuals undergoing CRC screening. The target conditions were CRC and advanced neoplasia (advanced adenomas and CRC combined).\nData collection and analysis\nTwo review authors independently screened and selected studies for inclusion. In case of disagreement, a third review author made the final decision. We used the Rutter and Gatsonis hierarchical summary receiver operating characteristic model to explore differences between tests and identify potential sources of heterogeneity, and the bivariate hierarchical model to estimate sensitivity and specificity at common thresholds: 10 µg haemoglobin (Hb)/g faeces and 20 µg Hb/g faeces. We performed indirect comparisons of the accuracy of the two tests and direct comparisons when both index tests were evaluated in the same population.\nMain results\nWe ran the initial search on 25 June 2019, which yielded 63 studies for inclusion. We ran a top-up search on 14 September 2021, which yielded one potentially eligible study, currently awaiting classification.\nWe included a total of 33 \"reference standard: all\" published articles involving 104,640 participants. Six studies evaluated only gFOBTs, 23 studies evaluated only FITs, and four studies included both gFOBTs and FITs. The cut-off for positivity of FITs varied between 2.4 μg and 50 µg Hb/g faeces. For each Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability than gFOBTs for AN (P < 0.001) and CRC (P = 0.004). For the detection of AN, the summary sensitivity of gFOBTs was 15% (95% confidence interval (CI) 12% to 20%), which was significantly lower than FITs at both 10 μg and 20 μg Hb/g cut-offs with summary sensitivities of 33% (95% CI 27% to 40%; P < 0.001) and 26% (95% CI 21% to 31%, P = 0.002), respectively. Results were simulated in a hypothetical cohort of 10,000 screening participants with 1% CRC prevalence and 10% AN prevalence. Out of 1000 participants with AN, gFOBTs missed 850, while FITs missed 670 (10 μg Hb/g cut-off) and 740 (20 μg Hb/g cut-off). No significant differences in summary specificity for AN detection were found between gFOBTs (94%; 95% CI 92% to 96%), and FITs at 10 μg Hb/g cut-off (93%; 95% CI 90% to 95%) and at 20 μg Hb/g cut-off (97%; 95% CI 95% to 98%). So, among 9000 participants without AN, 540 were offered (unnecessary) colonoscopy with gFOBTs compared to 630 (10 μg Hb/g) and 270 (20 μg Hb/g) with FITs. Similarly, for the detection of CRC, the summary sensitivity of gFOBTs, 39% (95% CI 25% to 55%), was significantly lower than FITs at 10 μg and 20 μg Hb/g cut-offs: 76% (95% CI 57% to 88%: P = 0.001) and 65% (95% CI 46% to 80%; P = 0.035), respectively. So, out of 100 participants with CRC, gFOBTs missed 61, and FITs missed 24 (10 μg Hb/g) and 35 (20 μg Hb/g). No significant differences in summary specificity for CRC were found between gFOBTs (94%; 95% CI 91% to 96%), and FITs at the 10 μg Hb/g cut-off (94%; 95% CI 87% to 97%) and 20 μg Hb/g cut-off (96%; 95% CI 91% to 98%). So, out of 9900 participants without CRC, 594 were offered (unnecessary) colonoscopy with gFOBTs versus 594 (10 μg Hb/g) and 396 (20 μg Hb/g) with FITs.\nIn five studies that compared FITs and gFOBTs in the same population, FITs showed a higher discriminative ability for AN than gFOBTs (P = 0.003).\nWe included a total of 30 \"reference standard: positive\" studies involving 3,664,934 participants. Of these, eight were gFOBT-only studies, 18 were FIT-only studies, and four studies combined both gFOBTs and FITs. The cut-off for positivity of FITs varied between 5 µg to 250 µg Hb/g faeces. For each QUADAS-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability for detecting CRC than gFOBTs (P < 0.001). The summary sensitivity for CRC of gFOBTs, 59% (95% CI 55% to 64%), was significantly lower than FITs at the 10 μg Hb/g cut-off, 89% (95% CI 80% to 95%; P < 0.001) and the 20 μg Hb/g cut-off, 89% (95% CI 85% to 92%; P < 0.001). So, in the hypothetical cohort with 100 participants with CRC, gFOBTs missed 41, while FITs missed 11 (10 μg Hb/g) and 11 (20 μg Hb/g). The summary specificity of gFOBTs was 98% (95% CI 98% to 99%), which was higher than FITs at both 10 μg and 20 μg Hb/g cut-offs: 94% (95% CI 92% to 95%; P < 0.001) and 95% (95% CI 94% to 96%; P < 0.001), respectively. So, out of 9900 participants without CRC, 198 were offered (unnecessary) colonoscopy with gFOBTs compared to 594 (10 μg Hb/g) and 495 (20 μg Hb/g) with FITs. At a specificity of 90% and 95%, FITs had a higher sensitivity than gFOBTs.\nAuthors' conclusions\nFITs are superior to gFOBTs in detecting AN and CRC in average-risk individuals. Specificity of both tests was similar in \"reference standard: all\" studies, whereas specificity was significantly higher for gFOBTs than FITs in \"reference standard: positive\" studies. However, at pre-specified specificities, the sensitivity of FITs was significantly higher than gFOBTs.\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": "One of the most common types of cancer diagnosed is large bowel or colorectal cancer (CRC). Early detection, before symptoms appear, makes it easier to treat bowel cancer and increases the chance of survival. Taking part in a bowel cancer screening program can lead to early detection and removal of large or advanced polyps (advanced adenomas), which are considered to be a precursor to bowel cancer. Simple faecal tests are used to detect the presence of blood in stool, which could be an early sign of bowel cancer or polyps. Two types of faecal blood tests used in population screening are: guaiac-based faecal occult blood tests (gFOBTs) and faecal immunochemical tests (FITs). Large, older studies have shown that screening with gFOBTs can reduce mortality. In a systematic review of the literature, we compared the accuracy of these two tests in order to assess which test gives the best results in population screening for bowel cancer, and, secondarily, for advanced neoplasia (which comprises bowel cancer and advanced polyps together)."
}
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query-laysum | 2507 | [
{
"role": "user",
"content": "Abstract: Background\nTo minimise the rate of recurrent prolapse after traditional native tissue repair (anterior colporrhaphy), clinicians have utilised a variety of surgical techniques.\nObjectives\nTo determine the safety and effectiveness of surgery for anterior compartment prolapse.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process (23 August 2016), handsearched journals and conference proceedings (15 February 2016) and searched trial registers (1 August 2016).\nSelection criteria\nRandomised controlled trials (RCTs) that examined surgical operations for anterior compartment prolapse.\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias and extracted data. Primary outcomes were awareness of prolapse, repeat surgery and recurrent prolapse on examination.\nMain results\nWe included 33 trials (3332 women). The quality of evidence ranged from very low to moderate. Limitations were risk of bias and imprecision. We have summarised results for the main comparisons.\nNative tissue versus biological graft\nAwareness of prolapse: Evidence suggested few or no differences between groups (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.52 to 1.82; five RCTs; 552 women; I2 = 39%; low-quality evidence), indicating that if 12% of women were aware of prolapse after biological graft, 7% to 23% would be aware after native tissue repair.\nRepeat surgery for prolapse: Results showed no probable differences between groups (RR 1.02, 95% CI 0.53 to 1.97; seven RCTs; 650 women; I2 = 0%; moderate-quality evidence), indicating that if 4% of women required repeat surgery after biological graft, 2% to 9% would do so after native tissue repair.\nRecurrent anterior compartment prolapse: Native tissue repair probably increased the risk of recurrence (RR 1.32, 95% CI 1.06 to 1.65; eight RCTs; 701 women; I2 = 26%; moderate-quality evidence), indicating that if 26% of women had recurrent prolapse after biological graft, 27% to 42% would have recurrence after native tissue repair.\nStress urinary incontinence (SUI): Results showed no probable differences between groups (RR 1.44, 95% CI 0.79 to 2.64; two RCTs; 218 women; I2 = 0%; moderate-quality evidence).\nDyspareunia: Evidence suggested few or no differences between groups (RR 0.87, 95% CI 0.39 to 1.93; two RCTs; 151 women; I2 = 0%; low-quality evidence).\nNative tissue versus polypropylene mesh\nAwareness of prolapse: This was probably more likely after native tissue repair (RR 1.77, 95% CI 1.37 to 2.28; nine RCTs; 1133 women; I2 = 0%; moderate-quality evidence), suggesting that if 13% of women were aware of prolapse after mesh repair, 18% to 30% would be aware of prolapse after native tissue repair.\nRepeat surgery for prolapse: This was probably more likely after native tissue repair (RR 2.03, 95% CI 1.15 to 3.58; 12 RCTs; 1629 women; I2 = 39%; moderate-quality evidence), suggesting that if 2% of women needed repeat surgery after mesh repair, 2% to 7% would do so after native tissue repair.\nRecurrent anterior compartment prolapse: This was probably more likely after native tissue repair (RR 3.01, 95% CI 2.52 to 3.60; 16 RCTs; 1976 women; I2 = 39%; moderate-quality evidence), suggesting that if recurrent prolapse occurred in 13% of women after mesh repair, 32% to 45% would have recurrence after native tissue repair.\nRepeat surgery for prolapse, stress urinary incontinence or mesh exposure (composite outcome): This was probably less likely after native tissue repair (RR 0.59, 95% CI 0.41 to 0.83; 12 RCTs; 1527 women; I2 = 45%; moderate-quality evidence), suggesting that if 10% of women require repeat surgery after polypropylene mesh repair, 4% to 8% would do so after native tissue repair.\nDe novo SUI: Evidence suggested few or no differences between groups (RR 0.67, 95% CI 0.44 to 1.01; six RCTs; 957 women; I2 = 26%; low-quality evidence). No evidence suggested a difference in rates of repeat surgery for SUI.\nDyspareunia (de novo): Evidence suggested few or no differences between groups (RR 0.54, 95% CI 0.27 to 1.06; eight RCTs; n = 583; I2 = 0%; low-quality evidence).\nNative tissue versus absorbable mesh\nAwareness of prolapse: It is unclear whether results showed any differences between groups (RR 0.95, 95% CI 0.70 to 1.31; one RCT; n = 54; very low-quality evidence),\nRepeat surgery for prolapse: It is unclear whether results showed any differences between groups (RR 2.13, 95% CI 0.42 to 10.82; one RCT; n = 66; very low-quality evidence).\nRecurrent anterior compartment prolapse: This is probably more likely after native tissue repair (RR 1.50, 95% CI 1.09 to 2.06; three RCTs; n = 268; I2 = 0%; moderate-quality evidence), suggesting that if 27% have recurrent prolapse after mesh repair, 29% to 55% would have recurrent prolapse after native tissue repair.\nSUI: It is unclear whether results showed any differences between groups (RR 0.72, 95% CI 0.50 to 1.05; one RCT; n = 49; very low-quality evidence).\nDyspareunia: No data were reported.\nAuthors' conclusions\nBiological graft repair or absorbable mesh provides minimal advantage compared with native tissue repair.\nNative tissue repair was associated with increased awareness of prolapse and increased risk of repeat surgery for prolapse and recurrence of anterior compartment prolapse compared with polypropylene mesh repair. However, native tissue repair was associated with reduced risk of de novo SUI, reduced bladder injury, and reduced rates of repeat surgery for prolapse, stress urinary incontinence and mesh exposure (composite outcome).\nCurrent evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.\nMany transvaginal polypropylene meshes have been voluntarily removed from the market, and newer light-weight transvaginal meshes that are available have not been assessed by RCTs. Clinicans and women should be cautious when utilising these products, as their safety and efficacy have not been established.\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": "Cochrane authors included in this review 33 randomised controlled trials (RCTs) evaluating 3332 surgeries to compare traditional native tissue anterior repair versus biological grafts (eight trials), absorbable mesh (three trials), permanent (polypropylene) mesh (16 trials) and abdominal paravaginal repair (two trials). Four trials compared a transvaginal graft versus another transvaginal graft, and four trials evaluated native tissue repair of anterior and/or posterior compartments of the vagina versus graft repair. Evidence is current to 23 August 2016."
}
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query-laysum | 2508 | [
{
"role": "user",
"content": "Abstract: Background\nDespite substantial improvements in the success of treatments through assisted reproduction technologies (ART), live birth rates remain constantly low, and practitioners are seeking aetiologic treatments to improve the outcomes.\nLocal inflammatory response is believed to contribute to implantation failure, where prostaglandins may increase uterine contractions and decrease uterine receptivity, decreasing the possibility of an IVF cycle leading to successful embryo transfer. In this context, nonsteroidal anti-inflammatory drugs (NSAIDs) have been employed to inhibit the negative prostaglandin effect. They are often offered in clinical practice to improve ART outcomes, but current robust evidence on their efficacy is lacking.\nObjectives\nTo evaluate the effectiveness and safety of nonsteroidal anti-inflammatory drugs as co-treatments in infertile women undergoing assisted reproduction, in terms of improving live birth and miscarriage rates.\nSearch methods\nWe designed the search using standard Cochrane methods and performed it on databases from their inception to 20 February 2019.\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL via the Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, and the trial registers for ongoing and registered trials, grey literature and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, and PubMed and Google for any recent trials. There were no restrictions by language or country of origin.\nSelection criteria\nAll RCTs on the use of NSAIDs as co-treatment during an ART cycle compared with no use or the use of placebo or any other similar drug, along with the comparison of any NSAID to another.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Our primary outcomes were live birth/ongoing pregnancy and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.\nMain results\nWe found 11 RCTs (1884 women) suitable for inclusion in the review. Most studies were at unclear or high risk of bias. The main limitations in the overall quality of the evidence were high risk of bias, unexplained heterogeneity and serious imprecision and indirectness.\nThere were no data on our primary outcome — live birth per woman randomised — in any review comparisons.\nNSAIDs vs. placebo/no treatment\nWe are uncertain of an effect on ongoing pregnancy when NSAIDs were compared to placebo/no treatment (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.71 to 1.59; 4 studies, 1159 participants; I² = 53%; very low quality evidence). Results suggest that if the chance of ongoing pregnancy following placebo or no treatment is assumed to be 15%, the chance following the use of NSAIDs is estimated to be between 12% and 24%. Subgroup analysis according to the type of NSAID yielded similar results.\nWe are also uncertain of an effect on miscarriage rates when NSAIDs were compared to placebo/no treatment (RR 0.62, 95% CI 0.33 to 1.16; 4 studies, 525 participants; I² = 43%; very low quality evidence). Results suggest that if the chance of miscarriage following placebo or no treatment is assumed to be 21%, the chance following the use of NSAIDs is estimated to be between 7% and 27%. The results were similar when two studies were excluded due to high risk of bias.\nConcerning the secondary outcomes, we are uncertain of an effect on clinical pregnancy rates (RR 1.23, 95% CI 1.00 to 1.52; 6 studies, 1570 participants; I² = 49%; low-quality evidence); on ectopic pregnancy (RR 0.56, 95% CI 0.05 to 5.89; 1 study, 72 participants); on multiple pregnancy (RR 2.00, 95% CI 0.18 to 21.67; 1 study, 180 participants); and on side effects (RR 1.39, 95% CI 0.02 to 119.35; 3 studies, 418 participants; I² = 79%). The evidence suggests that if the chance of clinical pregnancy following placebo or no treatment is assumed to be 30%, the chance following the use of NSAIDs is estimated to be between 31% and 45%. If the chance of ectopic pregnancy following placebo or no treatment is assumed to be 5%, the chance following the use of NSAIDs is estimated to be between 0.3% and 31%. If the chance of multiple pregnancy following placebo or no treatment is assumed to be 1%, the chance following the use of NSAIDs is estimated to be between 0.2 % and 24%.\nThere were no cases of congenital anomalies during antenatal ultrasound screening of the women in one study.\nNSAID vs. another NSAID\nOnly one study compared piroxicam with indomethacin: we are uncertain of an effect on ongoing pregnancy (RR 1.12, 95% CI 0.63 to 2.00; 1 study, 170 participants; very low quality evidence); and on miscarriage (RR 1.00, 95% CI 0.44 to 2.28; 1 study, 170 participants; very low quality evidence). The evidence suggests that if the chance of ongoing pregnancy following indomethacin is assumed to be 20%, the chance following the use of piroxicam is estimated to be between 13% and 40%; while for miscarriage, the evidence suggests that if the chance following indomethacin is assumed to be 12%, the chance following the use of piroxicam is estimated to be between 5% and 27%.\nSimilar results were reported for clinical pregnancy (RR 1.07, 95% CI 0.71 to 1.63; 1 study, 170 participants; very low quality evidence).\nThere were no data for the other outcomes specified in this review.\nNSAID vs. aspirin\nNo study reported this comparison.\nAuthors' conclusions\nCurrently we are uncertain of an effect of the routine use of NSAIDs as co-treatments in infertile women undergoing assisted reproduction in order to improve ongoing pregnancy and miscarriage rates. This is based on available data from RCTs, where very low quality evidence showed that there is no single outcome measure demonstrating a benefit with their use. Further large, well-designed randomised placebo-controlled trials reporting on live births are required to clarify the exact role of NSAIDs.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was very low for all outcomes. This is because of several limitations including poorly reported study methods, imprecision, small study numbers and low numbers of events reported."
}
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query-laysum | 2509 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking is a leading cause of disease and death worldwide. In people who smoke, quitting smoking can reverse much of the damage. Many people use behavioural interventions to help them quit smoking; these interventions can vary substantially in their content and effectiveness.\nObjectives\nTo summarise the evidence from Cochrane Reviews that assessed the effect of behavioural interventions designed to support smoking cessation attempts and to conduct a network meta-analysis to determine how modes of delivery; person delivering the intervention; and the nature, focus, and intensity of behavioural interventions for smoking cessation influence the likelihood of achieving abstinence six months after attempting to stop smoking; and whether the effects of behavioural interventions depend upon other characteristics, including population, setting, and the provision of pharmacotherapy.\nTo summarise the availability and principal findings of economic evaluations of behavioural interventions for smoking cessation, in terms of comparative costs and cost-effectiveness, in the form of a brief economic commentary.\nMethods\nThis work comprises two main elements. 1. We conducted a Cochrane Overview of reviews following standard Cochrane methods. We identified Cochrane Reviews of behavioural interventions (including all non-pharmacological interventions, e.g. counselling, exercise, hypnotherapy, self-help materials) for smoking cessation by searching the Cochrane Library in July 2020. We evaluated the methodological quality of reviews using AMSTAR 2 and synthesised data from the reviews narratively. 2. We used the included reviews to identify randomised controlled trials of behavioural interventions for smoking cessation compared with other behavioural interventions or no intervention for smoking cessation. To be included, studies had to include adult smokers and measure smoking abstinence at six months or longer. Screening, data extraction, and risk of bias assessment followed standard Cochrane methods. We synthesised data using Bayesian component network meta-analysis (CNMA), examining the effects of 38 different components compared to minimal intervention. Components included behavioural and motivational elements, intervention providers, delivery modes, nature, focus, and intensity of the behavioural intervention. We used component network meta-regression (CNMR) to evaluate the influence of population characteristics, provision of pharmacotherapy, and intervention intensity on the component effects. We evaluated certainty of the evidence using GRADE domains. We assumed an additive effect for individual components.\nMain results\nWe included 33 Cochrane Reviews, from which 312 randomised controlled trials, representing 250,563 participants and 845 distinct study arms, met the criteria for inclusion in our component network meta-analysis. This represented 437 different combinations of components. Of the 33 reviews, confidence in review findings was high in four reviews and moderate in nine reviews, as measured by the AMSTAR 2 critical appraisal tool. The remaining 20 reviews were low or critically low due to one or more critical weaknesses, most commonly inadequate investigation or discussion (or both) of the impact of publication bias. Of note, the critical weaknesses identified did not affect the searching, screening, or data extraction elements of the review process, which have direct bearing on our CNMA. Of the included studies, 125/312 were at low risk of bias overall, 50 were at high risk of bias, and the remainder were at unclear risk. Analyses from the contributing reviews and from our CNMA showed behavioural interventions for smoking cessation can increase quit rates, but effectiveness varies on characteristics of the support provided. There was high-certainty evidence of benefit for the provision of counselling (odds ratio (OR) 1.44, 95% credibility interval (CrI) 1.22 to 1.70, 194 studies, n = 72,273) and guaranteed financial incentives (OR 1.46, 95% CrI 1.15 to 1.85, 19 studies, n = 8877). Evidence of benefit remained when removing studies at high risk of bias. These findings were consistent with pair-wise meta-analyses from contributing reviews. There was moderate-certainty evidence of benefit for interventions delivered via text message (downgraded due to unexplained statistical heterogeneity in pair-wise comparison), and for the following components where point estimates suggested benefit but CrIs incorporated no clinically significant difference: individual tailoring; intervention content including motivational components; intervention content focused on how to quit. The remaining intervention components had low-to very low-certainty evidence, with the main issues being imprecision and risk of bias. There was no evidence to suggest an increase in harms in groups receiving behavioural support for smoking cessation. Intervention effects were not changed by adjusting for population characteristics, but data were limited. Increasing intensity of behavioural support, as measured through the number of contacts, duration of each contact, and programme length, had point estimates associated with modestly increased chances of quitting, but CrIs included no difference. The effect of behavioural support for smoking cessation appeared slightly less pronounced when people were already receiving smoking cessation pharmacotherapies.\nAuthors' conclusions\nBehavioural support for smoking cessation can increase quit rates at six months or longer, with no evidence that support increases harms. This is the case whether or not smoking cessation pharmacotherapy is also provided, but the effect is slightly more pronounced in the absence of pharmacotherapy. Evidence of benefit is strongest for the provision of any form of counselling, and guaranteed financial incentives. Evidence suggested possible benefit but the need of further studies to evaluate: individual tailoring; delivery via text message, email, and audio recording; delivery by lay health advisor; and intervention content with motivational components and a focus on how to quit. We identified 23 economic evaluations; evidence did not consistently suggest one type of behavioural intervention for smoking cessation was more cost-effective than another. Future reviews should fully consider publication bias. Tools to investigate publication bias and to evaluate certainty in CNMA are needed.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 33 Cochrane Reviews, from which we identified 312 relevant studies in 250,503 adults (aged 18 to 63 years) who smoked cigarettes. The studies investigated 437 different combinations of ways to stop smoking.\nMost studies were conducted in the USA or Western Europe; 115 studies took place in healthcare settings and 195 took place in the community. On average, people taking part in the studies were followed up for 10.5 months.\nThe studies compared the effects of behavioural support with:\n– no behavioural support;\n– usual or standard care;\n– less-intense forms of the behavioural support; or other approaches.\nWe compared all treatments with each other using a mathematical method called network meta-analysis."
}
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query-laysum | 2510 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in older people. Opioids may be a viable treatment option if people have severe pain or if other analgesics are contraindicated. However, the evidence about their effectiveness and safety is contradictory. This is an update of a Cochrane review first published in 2009.\nObjectives\nTo determine the effects on pain, function, safety, and addiction of oral or transdermal opioids compared with placebo or no intervention in people with knee or hip osteoarthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and CINAHL (up to 28 July 2008, with an update performed on 15 August 2012), checked conference proceedings, reference lists, and contacted authors.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that compared oral or transdermal opioids with placebo or no treatment in people with knee or hip osteoarthritis. We excluded studies of tramadol. We applied no language restrictions.\nData collection and analysis\nWe extracted data in duplicate. We calculated standardised mean differences (SMDs) and 95% confidence intervals (CI) for pain and function, and risk ratios for safety outcomes. We combined trials using an inverse-variance random-effects meta-analysis.\nMain results\nWe identified 12 additional trials and included 22 trials with 8275 participants in this update. Oral oxycodone was studied in 10 trials, transdermal buprenorphine and oral tapentadol in four, oral codeine in three, oral morphine and oral oxymorphone in two, and transdermal fentanyl and oral hydromorphone in one trial each. All trials were described as double-blind, but the risk of bias for other domains was unclear in several trials due to incomplete reporting. Opioids were more beneficial in pain reduction than control interventions (SMD -0.28, 95% CI -0.35 to -0.20), which corresponds to a difference in pain scores of 0.7 cm on a 10-cm visual analogue scale (VAS) between opioids and placebo. This corresponds to a difference in improvement of 12% (95% CI 9% to 15%) between opioids (41% mean improvement from baseline) and placebo (29% mean improvement from baseline), which translates into a number needed to treat (NNTB) to cause one additional treatment response on pain of 10 (95% CI 8 to 14). Improvement of function was larger in opioid-treated participants compared with control groups (SMD -0.26, 95% CI -0.35 to -0.17), which corresponds to a difference in function scores of 0.6 units between opioids and placebo on a standardised Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability scale ranging from 0 to 10. This corresponds to a difference in improvement of 11% (95% CI 7% to 14%) between opioids (32% mean improvement from baseline) and placebo (21% mean improvement from baseline), which translates into an NNTB to cause one additional treatment response on function of 11 (95% CI 7 to 14). We did not find substantial differences in effects according to type of opioid, analgesic potency, route of administration, daily dose, methodological quality of trials, and type of funding. Trials with treatment durations of four weeks or less showed larger pain relief than trials with longer treatment duration (P value for interaction = 0.001) and there was evidence for funnel plot asymmetry (P value = 0.054 for pain and P value = 0.011 for function). Adverse events were more frequent in participants receiving opioids compared with control. The pooled risk ratio was 1.49 (95% CI 1.35 to 1.63) for any adverse event (9 trials; 22% of participants in opioid and 15% of participants in control treatment experienced side effects), 3.76 (95% CI 2.93 to 4.82) for drop-outs due to adverse events (19 trials; 6.4% of participants in opioid and 1.7% of participants in control treatment dropped out due to adverse events), and 3.35 (95% CI 0.83 to 13.56) for serious adverse events (2 trials; 1.3% of participants in opioid and 0.4% of participants in control treatment experienced serious adverse events). Withdrawal symptoms occurred more often in opioid compared with control treatment (odds ratio (OR) 2.76, 95% CI 2.02 to 3.77; 3 trials; 2.4% of participants in opioid and 0.9% of participants control treatment experienced withdrawal symptoms).\nAuthors' conclusions\nThe small mean benefit of non-tramadol opioids are contrasted by significant increases in the risk of adverse events. For the pain outcome in particular, observed effects were of questionable clinical relevance since the 95% CI did not include the minimal clinically important difference of 0.37 SMDs, which corresponds to 0.9 cm on a 10-cm VAS.\n\nGiven the provided abstract, please respond to the following query: \"Side effects resulting in hospitalisation, persistent disability, or death\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- 13 people out of 1000 who used opioids experienced side effects resulting in hospitalisation, persistent disability, or death (1.3%).\n- 4 people out of 1000 who used a placebo experienced side effects resulting in hospitalisation, persistent disability, or deaths (0.4%).\n- 9 more people experienced side effects resulting in hospitalisation, persistent disability, or death with opioids than with placebo (difference of 0.9%). (Low-quality evidence)"
}
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query-laysum | 2511 | [
{
"role": "user",
"content": "Abstract: Background\nAcute graft-versus-host disease (aGvHD) is a major cause of morbidity and mortality after haematopoietic stem cell transplantation (HSCT), occurring in 8% to 85% of paediatric recipients. Currently, the therapeutic mainstay for aGvHD is treatment with corticosteroids. However, there is no established standard treatment for steroid-refractory aGvHD. Extracorporeal photopheresis (ECP) is a type of immunomodulatory method amongst different therapeutic options that involves ex vivo collection of peripheral mononuclear cells, exposure to the photoactive agent 8-methoxypsoralen and ultraviolet-A radiation, and reinfusion of these treated blood cells to the patient. The mechanisms of action of ECP are not completely understood. This is the second update of a Cochrane Review first published in 2014 and updated in 2015.\nObjectives\nTo evaluate the effectiveness and safety of ECP for the management of aGvHD in children and adolescents after HSCT.\nSearch methods\nWe searched the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE (PubMed) and Embase (Ovid) databases from their inception to 25 January 2021. We searched the reference lists of potentially relevant studies without any language restrictions. We searched five conference proceedings and nine clinical trial registries on 9 November 2020 and 12 November 2020, respectively.\nSelection criteria\nWe sought to include randomised controlled trials (RCTs) comparing ECP with or without standard treatment versus standard treatment alone in children and adolescents with aGvHD after HSCT.\nData collection and analysis\nTwo review authors independently performed the study selection. We resolved disagreement in the selection of trials by consultation with a third review author.\nMain results\nWe identified no additional studies in the 2021 review update, so there are still no studies that meet the criteria for inclusion in this review.\nAuthors' conclusions\nThe efficacy of ECP in the treatment of aGvHD in children and adolescents after HSCT is unknown, and its use should be restricted to within the context of RCTs. Such studies should address a comparison of ECP alone or in combination with standard treatment versus standard treatment alone. The 2021 review update brought about no additions to these conclusions.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The original version of this review and both the first and second review update did not find any RCTs investigating the efficacy of ECP in children and adolescents with acute graft-versus-host disease after HSCT. Current recommendations are based on retrospective studies (where outcomes occurred to the participants before the study began) or observational studies (where investigators did not intervene, and simply observed the course of events) only. We recommend the use of ECP in children and adolescents after HSCT only in the context of RCTs."
}
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query-laysum | 2512 | [
{
"role": "user",
"content": "Abstract: Background\nKnee arthroscopy (KA) is a routine orthopedic procedure recommended to repair cruciate ligaments and meniscus injuries and, in suitable cases, to assist the diagnosis of persistent knee pain. There is a small risk of thromboembolic events associated with KA. This systematic review aims to assess if pharmacological or non-pharmacological interventions may reduce this risk. This is an update of an earlier Cochrane Review.\nObjectives\nTo evaluate the efficacy and safety of interventions – whether mechanical, pharmacological, or a combination of both – for thromboprophylaxis in adults undergoing KA.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 1 June 2021.\nSelection criteria\nWe included randomized controlled trials (RCTs) and controlled clinical trials (CCTs), blinded or unblinded, of all types of interventions used to prevent deep vein thrombosis (DVT) in men and women aged 18 years and older undergoing KA.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were pulmonary embolism (PE), symptomatic DVT, asymptomatic DVT, and all-cause mortality. Our secondary outcomes were adverse effects, major bleeding, and minor bleeding. We used GRADE criteria to assess the certainty of the evidence.\nMain results\nWe did not identify any new studies for this update. This review includes eight studies involving 3818 adults with no history of thromboembolic disease. Five studies compared daily subcutaneous low-molecular-weight heparin (LMWH) versus no prophylaxis; one study compared oral rivaroxaban 10 mg versus placebo; one study compared daily subcutaneous LMWH versus graduated compression stockings; and one study compared aspirin versus no prophylaxis.\nThe incidence of PE in all studies combined was low, with seven cases in 3818 participants. There were no deaths in any of the intervention or control groups.\nLow-molecular-weight heparin versus no prophylaxis\nWhen compared with no prophylaxis, LMWH probably results in little to no difference in the incidence of PE in people undergoing KA (risk ratio [RR] 1.81, 95% confidence interval [CI] 0.49 to 6.65; 3 studies, 1820 participants; moderate-certainty evidence). LMWH may make little or no difference to the incidence of symptomatic DVT (RR 0.61, 95% CI 0.18 to 2.03; 4 studies, 1848 participants; low-certainty evidence). It is uncertain whether LMWH reduces the risk of asymptomatic DVT (RR 0.14, 95% CI 0.03 to 0.61; 2 studies, 369 participants; very low-certainty evidence). LMWH probably makes little or no difference to the risk of all adverse effects combined (RR 1.85, 95% CI 0.95 to 3.59; 5 studies, 1978 participants; moderate-certainty evidence), major bleeding (RR 0.98, 95% CI 0.06 to 15.72; 1451 participants; moderate-certainty evidence), or minor bleeding (RR 1.79, 95% CI 0.84 to 3.84; 5 studies, 1978 participants; moderate-certainty evidence).\nRivaroxaban versus placebo\nOne study with 234 participants compared oral rivaroxaban 10 mg versus placebo. There were no cases of PE reported. Rivaroxaban probably led to little or no difference in symptomatic DVT (RR 0.16, 95% CI 0.02 to 1.29; moderate-certainty evidence). It is uncertain whether rivaroxaban reduces the risk of asymptomatic DVT because the certainty of the evidence is very low (RR 0.95, 95% CI 0.06 to 15.01). The study only reported bleeding adverse effects. No major bleeds occurred in either group, and rivaroxaban probably made little or no difference to minor bleeding (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence).\nAspirin versus no prophylaxis\nOne study compared aspirin with no prophylaxis. There were no PE, DVT or asymptomatic events detected in either group. The study authors reported adverse effects including pain and swelling, but without clarifying which groups these occurred in. There were no bleeds reported.\nLow-molecular-weight heparin versus compression stockings\nOne study with 1317 participants compared LMWH versus compression stockings. LMWH may lead to little or no difference in the risk of PE compared to compression stockings (RR 1.00, 95% CI 0.14 to 7.05; low-certainty evidence), but it may reduce the risk of symptomatic DVT (RR 0.17, 95% CI 0.04 to 0.75; low-certainty evidence). It is uncertain whether LMWH has any effect on asymptomatic DVT (RR 0.47, 95% CI 0.21 to 1.09; very low-certainty evidence). The results suggest LMWH probably leads to little or no difference in major bleeding (RR 3.01, 95% CI 0.61 to 14.88; moderate-certainty evidence), or minor bleeding (RR 1.16, 95% CI 0.64 to 2.08; moderate-certainty evidence).\nWe downgraded the certainty of the evidence for imprecision due to overall small event numbers, for risk of bias due to concerns about lack of blinding, and for indirectness due to uncertainty about the direct clinical relevance of asymptomatic DVT detection.\nAuthors' conclusions\nThere is a small risk that healthy adults undergoing KA will develop venous thromboembolism (PE or DVT). We found moderate- to low-certainty evidence of little or no benefit from LMWH, or rivaroxaban in reducing this small risk of PE or symptomatic DVT. The studies provided very low-certainty evidence that LMWH may reduce the risk of asymptomatic DVT compared to no prophylaxis, but it is uncertain how this directly relates to incidence of DVT or PE in healthy people undergoing KA. There is probably little or no difference in adverse effects (including major and minor bleeding), but data relating to these outcomes were limited by low numbers of events in the studies reporting these outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In knee arthroscopy, a healthcare provider inserts a tiny camera through a small cut in the person's knee. Knee arthroscopy is used to diagnose and repair many types of knee injuries. People who undergo this procedure have a small risk of developing a blood clot in the deep veins of their legs (deep vein thrombosis). Those who get deep vein thrombosis may have symptoms such as calf pain or swelling (symptomatic deep vein thrombosis). There is also a risk that the clots may move to the lungs (pulmonary embolism). People who have surgery often receive medications to lower the risk of clots developing. These medications help to prevent blood clots by thinning the blood, and they may cause side effects such as bleeding. Because the risk of getting a blood clot after knee arthroscopy is small, it is important to know if taking medication to prevent clots is necessary."
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query-laysum | 2513 | [
{
"role": "user",
"content": "Abstract: Background\nSecond language (L2) learners are a heterogeneous group. Their L2 skills are highly varied due to internal factors (e.g. cognitive development) and external factors (e.g. cultural and linguistic contexts). As a group, their L2 vocabulary skills appear to be lower than their monolingual peers. This pattern tends to persist over time and may have negative consequences for social interaction and inclusion, learning, and academic achievement.\nObjectives\nTo examine the immediate and long-term effects of second language (L2) vocabulary interventions targeting L2 learners up to six years of age on vocabulary and social-emotional well-being.\nTo examine the associations between L2 vocabulary interventions and the general characteristics of L2 learners (e.g. age, L2 exposure, and L1 skills).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was December 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effects of vocabulary interventions for L2 learners up to six years of age with standard care.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were 1. receptive and 2. expressive L2 vocabulary (both proximal and distal), and 3. mean length of utterance (MLU; which is a measure of potential adverse effects). Our secondary outcomes were 4. L2 narrative skills, 5. L1 receptive vocabulary (both proximal and distal), 6. L1 expressive vocabulary (both proximal and distal), 7. L1 listening comprehension, 8. L2 grammatical knowledge, 9. L2 reading comprehension (long-term), and 10. socio-emotional well-being (measured with Strengths and Difficulties Questionnaire).\nMain results\nWe found 12 studies involving 1943 participants. Two studies were conducted in Norway, seven in the USA, and single studies conducted in Canada, China, and the Netherlands.\nTen studies were conducted in preschool settings, with a preschool teacher being the most common delivery agent for the intervention. The interventions were mainly organised as small-group sessions, with three or four children per group. The mean dosage per week was 80 minutes and ranged from 24 to 120 minutes.\nThe studies commonly applied shared book reading (reading aloud with the children), with target words embedded in the books.\nStandard care differed based on the setting and local conditions in each country or (pre)school. In some studies, the comparison groups received vocabulary instruction in preschool groups.\nCompared to standard care, the effect of L2 vocabulary interventions varied across outcome measures. For vocabulary measures including words that were taught in the intervention (proximal outcome measures), the intervention effects were large for both receptive L2 vocabulary (i.e. understanding of words; standardised mean difference (SMD) 0.97, 95% confidence interval (CI) 0.64 to 1.30; 4 studies, 1973 participants; very low-certainty evidence) and expressive L2 vocabulary (i.e. expressing or producing words; SMD 0.86, 95% CI 0.56 to 1.17; 6 studies, 1121 participants; very low-certainty evidence). However, due to some concerns in the overall risk of bias assessment, substantial heterogeneity, and wide CIs, we have limited confidence in these results.\nFor language measures that did not include taught vocabulary (distal outcome measures), the intervention effects were small for receptive vocabulary (SMD 0.29, 95% CI 0.02 to 0.55; 6 studies, 1074 participants; low-certainty evidence) and probably made little to no difference to expressive vocabulary (SMD 0.10, 95% CI −0.02 to 0.23; 7 studies, 960 participants; moderate-certainty evidence). There was little to no intervention effect on L2 listening comprehension (SMD 0.19, 95% CI −0.31 to 0.68; 2 studies, 294 participants; very low-certainty evidence), but the evidence was uncertain, and the interventions probably increased L2 narrative skills slightly (SMD 0.37, 95% CI 0.14 to 0.59; 2 studies, 487 participants; moderate-certainty evidence). Only one study reported data on MLU, and we were unable to examine the effect of intervention on this outcome. The level of certainty of the evidence was downgraded mainly due to inconsistency and imprecision.\nWe were unable to draw conclusions about socio-emotional well-being, or conduct the planned subgroup analyses to examine the second objective, due to lack of data.\nAuthors' conclusions\nFindings from this review suggest that, compared to standard care, vocabulary interventions may benefit children's L2 vocabulary learning but have little to no effect on their listening comprehension, though the evidence is uncertain. Vocabulary interventions probably improve the children's storytelling skills slightly.\nDue to the limited number of studies that met our inclusion criteria and the very low- to moderate-certainty evidence as a result of inconsistency and imprecision, implications for practice should be considered with caution.\nThis review highlights the need for more high-quality trials (e.g. RCTs) of vocabulary interventions for L2 learners, particularly studies of learners outside the USA.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The primary objective was to examine the immediate and long-term effects of vocabulary interventions targeting L2 learners up to six years of age on vocabulary and social-emotional well-being (ability to understand and manage emotions, make responsible decisions, build and maintain relationships, and understand and empathise with others). The secondary objective was to examine the associations between L2 vocabulary interventions and the general characteristics of L2 learners (e.g. age, L2 exposure and L1 skills)."
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query-laysum | 2514 | [
{
"role": "user",
"content": "Abstract: Background\nCarotid artery stenosis is an important cause of stroke and transient ischemic attack. Correctly and rapidly identifying patients with symptomatic carotid artery stenosis is essential for adequate treatment with early cerebral revascularization. Doubts about the diagnostic value regarding the accuracy of duplex ultrasound (DUS) and the possibility of using DUS as the single diagnostic test before carotid revascularization are still debated.\nObjectives\nTo estimate the accuracy of DUS in individuals with symptomatic carotid stenosis verified by either digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA).\nSearch methods\nWe searched CRDTAS, CENTRAL, MEDLINE (Ovid), Embase (Ovid), ISI Web of Science, HTA, DARE, and LILACS up to 15 February 2021. We handsearched the reference lists of all included studies and other relevant publications and contacted experts in the field to identify additional studies or unpublished data.\nSelection criteria\nWe included studies assessing DUS accuracy against an acceptable reference standard (DSA, MRA, or CTA) in symptomatic patients. We considered the classification of carotid stenosis with DUS defined with validated duplex velocity criteria, and the NASCET criteria for carotid stenosis measures on DSA, MRA, and CTA. We excluded studies that included < 70% of symptomatic patients; the time between the index test and the reference standard was longer than four weeks or not described, or that presented no objective criteria to estimate carotid stenosis.\nData collection and analysis\nThe review authors independently screened articles, extracted data, and assessed the risk of bias and applicability concerns using the QUADAS-2 domain list. We extracted data with an effort to complete a 2 × 2 table (true positives, true negatives, false positives, and false negatives) for each of the different categories of carotid stenosis and reference standards. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where meta-analysis was possible, we used a bivariate meta-analysis model.\nMain results\nWe identified 25,087 unique studies, of which 22 were deemed eligible for inclusion (4957 carotid arteries). The risk of bias varied considerably across the studies, and studies were generally of moderate to low quality. We narratively described the results without meta-analysis in seven studies in which the criteria used to determine stenosis were too different from the duplex velocity criteria proposed in our protocol or studies that provided insufficient data to complete a 2 × 2 table for at least in one category of stenosis. Nine studies (2770 carotid arteries) presented DUS versus DSA results for 70% to 99% carotid artery stenosis, and two (685 carotid arteries) presented results from DUS versus CTA in this category. Seven studies presented results for occlusion with DSA as the reference standard and three with CTA as the reference standard. Five studies compared DUS versus DSA for 50% to 99% carotid artery stenosis. Only one study presented results from 50% to 69% carotid artery stenosis.\nFor DUS versus DSA, for < 50% carotid artery stenosis, the summary sensitivity was 0.63 (95% confidence interval [CI] 0.48 to 0.76) and the summary specificity was 0.99 (95% CI 0.96 to 0.99); for the 50% to 69% range, only one study was included and meta-analysis not performed; for the 50% to 99% range, the summary sensitivity was 0.97 (95% CI 0.95 to 0.98) and the summary specificity was 0.70 (95% CI 0.67 to 0.73); for the 70% to 99% range, the summary sensitivity was 0.85 (95% CI 0.77 to 0.91) and the summary specificity was 0.98 (95% CI 0.74 to 0.90); for occlusion, the summary sensitivity was 0.91 (95% CI 0.81 to 0.97) and the summary specificity was 0.95 (95% CI 0.76 to 0.99).\nFor sensitivity analyses, excluding studies in which participants were selected based on the presence of occlusion on DUS had an impact on specificity: 0.98 (95% CI 0.97 to 0.99). For DUS versus CTA, we found two studies in the range of 70% to 99%; the sensitivity varied from 0.57 to 0.94 and the specificity varied from 0.87 to 0.98. For occlusion, the summary sensitivity was 0.95 (95% CI 0.80 to 0.99) and the summary specificity was 0.91 (95% CI 0.09 to 0.99). For DUS versus MRA, there was one study with results for 50% to 99% carotid artery stenosis, with a sensitivity of 0.88 (95% CI 0.70 to 0.98) and specificity of 0.60 (95% CI 0.15 to 0.95); in the 70% to 99% range, two studies were included, with sensitivity that varied from 0.54 to 0.99 and specificity that varied from 0.78 to 0.89. We could perform only a few of the proposed sensitivity analyses because of the small number of studies included.\nAuthors' conclusions\nThis review provides evidence that the diagnostic accuracy of DUS is high, especially at discriminating between the presence or absence of significant carotid artery stenosis (< 50% or 50% to 99%). This evidence, plus its less invasive nature, supports the early use of DUS for the detection of carotid artery stenosis. The accuracy for 70% to 99% carotid artery stenosis and occlusion is high. Clinicians should exercise caution when using DUS as the single preoperative diagnostic method, and the limitations should be considered. There was little evidence of the accuracy of DUS when compared with CTA or MRA. The results of this review should be interpreted with caution because they are based on studies of low methodological quality, mainly due to the patient selection method. Methodological problems in participant inclusion criteria from the studies discussed above apparently influenced an overestimated estimate of prevalence values. Most of the studies included failed to precisely describe inclusion criteria and previous testing. Future diagnostic accuracy studies should include direct comparisons of the various modalities of diagnostic tests (mainly DUS, CTA, and MRA) for carotid artery stenosis since DSA is no longer considered to be the best method for diagnosing carotid stenosis and less invasive tests are now used as reference standards in clinical practice. Also, for future studies, the participant inclusion criteria require careful attention.\n\nGiven the provided abstract, please respond to the following query: \"For DUS versus DSA\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "< 50% CAS (4 studies, 1495 carotid arteries): Estimated 299 patients would have a DUS result indicating the presence of non-significant CAS, of whom eight (2.7%) would be incorrectly classified. Of the 701 people with a result indicating that < 50% carotid stenosis is not present, 169 (24.1%) would be incorrectly classified.\n50% to 99% CAS (5 studies, 1536 carotid arteries): Estimated 642 patients would have a DUS result indicating the presence of 50% to 99% CAS; of these, 147 (22.8%) would be incorrectly classified. Of the 358 people with a result indicating that 50% to 99% carotid stenosis is not present, 15 (4.2%) would be incorrectly classified.\n70% to 99% CAS (9 studies, 2770 carotid arteries): Estimated 390 patients would have a DUS result indicating the presence of 70% to 99% CAS; of these, eight (2%) would be incorrectly classified. Of the 610 people with a result indicating that 70% to 99% carotid stenosis is not present, 68 (11.1%) would be incorrectly classified.\nOcclusion (7 studies, 1212 carotid arteries): Estimated 205 patients would have a DUS result indicating carotid artery occlusion; of these, 41 (20%) would be incorrectly classified. Of the 795 people with a result indicating that carotid occlusion is not present, 16 (2%) would be incorrectly classified."
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query-laysum | 2515 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom in people with cancer; 30% to 50% of people with cancer will experience moderate-to-severe pain. This can have a major negative impact on their quality of life. Opioid (morphine-like) medications are commonly used to treat moderate or severe cancer pain, and are recommended for this purpose in the World Health Organization (WHO) pain treatment ladder. Pain is not sufficiently relieved by opioid medications in 10% to 15% of people with cancer. In people with insufficient relief of cancer pain, new analgesics are needed to effectively and safely supplement or replace opioids.\nObjectives\nTo evaluate the benefits and harms of cannabis-based medicines, including medical cannabis, for treating pain and other symptoms in adults with cancer compared to placebo or any other established analgesic for cancer pain.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 26 January 2023.\nSelection criteria\nWe selected double-blind randomised, controlled trials (RCT) of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment for cancer pain in adults, with any treatment duration and at least 10 participants per treatment arm.\nData collection and analysis\nWe used standard Cochrane methods. The primary outcomes were 1. proportions of participants reporting no worse than mild pain; 2. Patient Global Impression of Change (PGIC) of much improved or very much improved and 3. withdrawals due to adverse events. Secondary outcomes were 4. number of participants who reported pain relief of 30% or greater and overall opioid use reduced or stable; 5. number of participants who reported pain relief of 30% or greater, or 50% or greater; 6. pain intensity; 7. sleep problems; 8. depression and anxiety; 9. daily maintenance and breakthrough opioid dosage; 10. dropouts due to lack of efficacy; 11. all central nervous system adverse events. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified 14 studies involving 1823 participants. No study assessed the proportions of participants reporting no worse than mild pain on treatment by 14 days after start of treatment.\nWe found five RCTs assessing oromucosal nabiximols (tetrahydrocannabinol (THC) and cannabidiol (CBD)) or THC alone involving 1539 participants with moderate or severe pain despite opioid therapy. The double-blind periods of the RCTs ranged between two and five weeks. Four studies with a parallel design and 1333 participants were available for meta-analysis.\nThere was moderate-certainty evidence that there was no clinically relevant benefit for proportions of PGIC much or very much improved (risk difference (RD) 0.06, 95% confidence interval (CI) 0.01 to 0.12; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 8 to 100). There was moderate-certainty evidence for no clinically relevant difference in the proportion of withdrawals due to adverse events (RD 0.04, 95% CI 0 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 16 to endless). There was moderate-certainty evidence for no difference between nabiximols or THC and placebo in the frequency of serious adverse events (RD 0.02, 95% CI −0.03 to 0.07). There was moderate-certainty evidence that nabiximols and THC used as add-on treatment for opioid-refractory cancer pain did not differ from placebo in reducing mean pain intensity (standardised mean difference (SMD) −0.19, 95% CI −0.40 to 0.02).\nThere was low-certainty evidence that a synthetic THC analogue (nabilone) delivered over eight weeks was not superior to placebo in reducing pain associated with chemotherapy or radiochemotherapy in people with head and neck cancer and non-small cell lung cancer (2 studies, 89 participants, qualitative analysis). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that synthetic THC analogues were superior to placebo (SMD −0.98, 95% CI −1.36 to −0.60), but not superior to low-dose codeine (SMD 0.03, 95% CI −0.25 to 0.32; 5 single-dose trials; 126 participants) in reducing moderate-to-severe cancer pain after cessation of previous analgesic treatment for three to four and a half hours (2 single-dose trials; 66 participants). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that CBD oil did not add value to specialist palliative care alone in the reduction of pain intensity in people with advanced cancer. There was no difference in the number of dropouts due to adverse events and serious adverse events (1 study, 144 participants, qualitative analysis).\nWe found no studies using herbal cannabis.\nAuthors' conclusions\nThere is moderate-certainty evidence that oromucosal nabiximols and THC are ineffective in relieving moderate-to-severe opioid-refractory cancer pain. There is low-certainty evidence that nabilone is ineffective in reducing pain associated with (radio-) chemotherapy in people with head and neck cancer and non-small cell lung cancer. There is low-certainty evidence that a single dose of synthetic THC analogues is not superior to a single low-dose morphine equivalent in reducing moderate-to-severe cancer pain. There is low-certainty evidence that CBD does not add value to specialist palliative care alone in the reduction of pain in people with advanced cancer.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 14 studies involving 1823 people. The biggest study included 399 people and the smallest study included 10 people.\nStudies were conducted in countries around the world; most (six) were based in North America.\nFive studies used one dose of CbM and lasted less than one day. Other studies lasted between two and eight weeks.\nPharmaceutical companies funded seven studies.\nSix studies compared a mouth spray with a plant-derived combination of tetrahydrocannabinol (THC), the principal psychoactive constituent of cannabis, and cannabidiol (CBD), an anti-inflammatory ingredient of cannabis, against a fake medication (placebo). Seven studies compared an artificial cannabinoid mimicking the effects of THC against placebo. Of these seven studies, two studies compared against a morphine-like medication (codeine), too. One study compared CBD against placebo.\nWe did not find studies with herbal cannabis."
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query-laysum | 2516 | [
{
"role": "user",
"content": "Abstract: Background\nOvarian cancer has the highest mortality rate of all gynaecological malignancies with an overall five-year survival rate of 30% to 40%. In the past two decades it has become apparent and more commonly accepted that a majority of ovarian cancers originate in the fallopian tube epithelium and not from the ovary itself. This paradigm shift introduced new possibilities for ovarian cancer prevention. Salpingectomy during a hysterectomy for benign gynaecological indications (also known as opportunistic salpingectomy) might reduce the overall incidence of ovarian cancer. Aside from efficacy, safety is of utmost importance, especially due to the preventive nature of opportunistic salpingectomy. Most important are safety in the form of surgical adverse events and postoperative hormonal status. Therefore, we compared the benefits and risks of hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy.\nObjectives\nTo assess the effect and safety of hysterectomy with opportunistic salpingectomy versus hysterectomy without salpingectomy for ovarian cancer prevention in women undergoing hysterectomy for benign gynaecological indications; outcomes of interest include the incidence of epithelial ovarian cancer, surgery-related adverse events and postoperative ovarian reserve.\nSearch methods\nThe Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two clinical trial registers were searched in January 2019 together with reference checking and contact with study authors.\nSelection criteria\nWe intended to include both randomised controlled trials (RCTs) and non-RCTs that compared ovarian cancer incidence after hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For assessment of surgical and hormonal safety, we included RCTs that compared hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were ovarian cancer incidence, intraoperative and short-term postoperative complication rate and postoperative hormonal status. Secondary outcomes were total surgical time, estimated blood loss, conversion rate to open surgery (applicable only to laparoscopic and vaginal approaches), duration of hospital admission, menopause-related symptoms and quality of life.\nMain results\nWe included seven RCTs (350 women analysed). The evidence was of very low to low quality: the main limitations being a low number of included women and surgery-related adverse events, substantial loss to follow-up and a large variety in outcome measures and timing of measurements.\nNo studies reported ovarian cancer incidence after hysterectomy with opportunistic salpingectomy compared to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For surgery-related adverse events, there were insufficient data to assess whether there was any difference in both intraoperative (odds ratio (OR) 0.66, 95% confidence interval (CI) 0.11 to 3.94; 5 studies, 286 participants; very low-quality evidence) and short-term postoperative (OR 0.13, 95% CI 0.01 to 2.14; 3 studies, 152 participants; very low-quality evidence) complication rates between hysterectomy with opportunistic salpingectomy and hysterectomy without opportunistic salpingectomy because the number of surgery-related adverse events was very low. For postoperative hormonal status, the results were compatible with no difference, or with a reduction in anti-Müllerian hormone (AMH) that would not be clinically relevant (mean difference (MD) -0.94, 95% CI -1.89 to 0.01; I2 = 0%; 5 studies, 283 participants; low-quality evidence). A reduction in AMH would be unfavourable, but due to wide CIs, the postoperative change in AMH can still vary from a substantial decrease to even a slight increase.\nAuthors' conclusions\nThere were no eligible studies reporting on one of our primary outcomes - the incidence of ovarian cancer specifically after hysterectomy with or without opportunistic salpingectomy. In our meta-analyses we found insufficient data to assess whether there was any difference in surgical adverse events, with a very low number of events in women undergoing hysterectomy with and without opportunistic salpingectomy. For postoperative hormonal status we found no evidence of a difference between the groups. The maximum difference in time to menopause, calculated from the lower limit of the 95% CI and the natural average AMH decline, would be approximately 20 months, which we consider to be not clinically relevant. However, the results should be interpreted with caution and even more so in very young women for whom a difference in postoperative hormonal status is potentially more clinically relevant. Therefore, there is a need for research on the long-term effects of opportunistic salpingectomy during hysterectomy, particularly in younger women, as results are currently limited to six months postoperatively. This limit is especially important as AMH, the most frequently used marker for ovarian reserve, recovers over the course of several months following an initial sharp decline after surgery. In light of the available evidence, addition of opportunistic salpingectomy should be discussed with each woman undergoing a hysterectomy for benign indication, with provision of a clear overview of benefits and risks.\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 found seven randomised controlled trials comparing hysterectomy with salpingectomy to hysterectomy without salpingectomy. They included a total of 350 women undergoing a hysterectomy for benign conditions of the female reproductive tract. The evidence is current to January 2019."
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query-laysum | 2517 | [
{
"role": "user",
"content": "Abstract: Background\nCognitive impairment, a defining feature of dementia, plays an important role in the compromised functional independence that characterises the condition. Cognitive training (CT) is an approach that uses guided practice on structured tasks with the direct aim of improving or maintaining cognitive abilities.\nObjectives\n• To assess effects of CT on cognitive and non-cognitive outcomes for people with mild to moderate dementia and their caregivers.\n• To compare effects of CT with those of other non-pharmacological interventions, including cognitive stimulation or rehabilitation, for people with mild to moderate dementia and their caregivers.\n• To identify and explore factors related to intervention and trial design that may be associated with the efficacy of CT for people with mild to moderate dementia and their caregivers.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialised Register, on 5 July 2018. ALOIS contains records of clinical trials identified through monthly searches of several major healthcare databases and numerous trial registries and grey literature sources. In addition to this, we searched MEDLINE, Embase, PsycINFO, CINAHL, LILACS, Web of Science Core Collection, ClinicalTrials.gov, and the World Health Organization's trials portal, ICTRP, to ensure that searches were comprehensive and up-to-date.\nSelection criteria\nWe included randomised controlled trials (RCTs) that described interventions for people with mild to moderate dementia and compared CT versus a control or alternative intervention.\nData collection and analysis\nWe extracted relevant data from published manuscripts and through contact with trial authors if required. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We divided comparison conditions into active or passive control conditions and alternative treatments. We used a large number of measures and data to evaluate 19 outcomes at end of treatment, as well as 16 outcomes at follow-up in the medium term; we pooled this information in meta-analyses. We calculated pooled estimates of treatment effect using a random-effects model, and we estimated statistical heterogeneity using a standard Chi² statistic. We graded the evidence using GradePro.\nMain results\nThe 33 included trials were published between 1988 and 2018 and were conducted in 12 countries; most were unregistered, parallel-group, single-site RCTs, with samples ranging from 12 to 653 participants. Interventions were between two and 104 weeks long. We classified most experimental interventions as 'straight CT', but we classified some as 'augmented CT', and about two-thirds as multi-domain interventions. Researchers investigated 18 passive and 13 active control conditions, along with 15 alternative treatment conditions, including occupational therapy, mindfulness, reminiscence therapy, and others.\nThe methodological quality of studies varied, but we rated nearly all studies as having high or unclear risk of selection bias due to lack of allocation concealment, and high or unclear risk of performance bias due to lack of blinding of participants and personnel.\nWe used data from 32 studies in the meta-analysis of at least one outcome. Relative to a control condition, we found moderate-quality evidence showing a small to moderate effect of CT on our first primary outcome, composite measure of global cognition at end of treatment (standardised mean difference (SMD) 0.42, 95% confidence interval (CI) 0.23 to 0.62), and high-quality evidence showing a moderate effect on the secondary outcome of verbal semantic fluency (SMD 0.52, 95% CI 0.23 to 0.81) at end of treatment, with these gains retained in the medium term (3 to 12 months post treatment). In relation to many other outcomes, including our second primary outcome of clinical disease severity in the medium term, the quality of evidence was very low, so we were unable to determine whether CT was associated with any meaningful gains.\nWhen compared with an alternative treatment, we found that CT may have little to no effect on our first primary outcome of global cognition at end of treatment (SMD 0.21, 95% CI -0.23 to 0.64), but the quality of evidence was low. No evidence was available to assess our second primary outcome of clinical disease severity in the medium term. We found moderate-quality evidence showing that CT was associated with improved mood of the caregiver at end of treatment, but this was based on a single trial. The quality of evidence in relation to many other outcomes at end of treatment and in the medium term was too low for us to determine whether CT was associated with any gains, but we are moderately confident that CT did not lead to any gains in mood, behavioural and psychological symptoms, or capacity to perform activities of daily living.\nAuthors' conclusions\nRelative to a control intervention, but not to a variety of alternative treatments, CT is probably associated with small to moderate positive effects on global cognition and verbal semantic fluency at end of treatment, and these benefits appear to be maintained in the medium term. Our certainty in relation to many of these findings is low or very low. Future studies should take stronger measures to mitigate well-established risks of bias, and should provide long-term follow-up to improve our understanding of the extent to which observed gains are retained. Future trials should also focus on direct comparison of CT versus alternative treatments rather than passive or active control conditions.\n\nGiven the provided abstract, please respond to the following query: \"Main findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We analysed data from 33 studies of CT that included a total of approximately 2000 participants and were conducted in 12 countries. We found that, compared with receiving usual treatment or engaging in non-specific activities, people completing CT may show some benefits in overall cognition, as well as in more specific cognitive abilities such as verbal fluency, and that improvements may last for at least a few months. We did not find any evidence that participating in CT was associated with increased burden for participants. However, we also found no evidence that CT was better than participating in other active treatments."
}
]
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query-laysum | 2518 | [
{
"role": "user",
"content": "Abstract: Background\nManagement of the open abdomen is a considerable burden for patients and healthcare professionals. Various temporary abdominal closure techniques have been suggested for managing the open abdomen. In recent years, negative pressure wound therapy (NPWT) has been used in some centres for the treatment of non-trauma patients with an open abdomen; however, its effectiveness is uncertain.\nObjectives\nTo assess the effects of negative pressure wound therapy (NPWT) on primary fascial closure for managing the open abdomen in non-trauma patients in any care setting.\nSearch methods\nIn October 2021 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. To identify additional studies, we also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports. There were no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared NPWT with any other type of temporary abdominal closure (e.g. Bogota bag, Wittmann patch) in non-trauma patients with open abdomen in any care setting. We also included RCTs that compared different types of NPWT systems for managing the open abdomen in non-trauma patients.\nData collection and analysis\nTwo review authors independently performed the study selection process, risk of bias assessment, data extraction, and GRADE assessment of the certainty of evidence.\nMain results\nWe included two studies, involving 74 adults with open abdomen associated with various conditions, predominantly severe peritonitis (N = 55). The mean age of the participants was 52.8 years; the mean proportion of women was 39.2%. Both RCTs were carried out in single centres and were at high risk of bias.\nNegative pressure wound therapy versus Bogota bag\nWe included one study (40 participants) comparing NPWT with Bogota bag. We are uncertain whether NPWT reduces time to primary fascial closure of the abdomen (NPWT: 16.9 days versus Bogota bag: 20.5 days (mean difference (MD) -3.60 days, 95% confidence interval (CI) -8.16 to 0.96); very low-certainty evidence) or adverse events (fistulae formation, NPWT: 10% versus Bogota: 5% (risk ratio (RR) 2.00, 95% CI 0.20 to 20.33); very low-certainty evidence) compared with the Bogota bag. We are also uncertain whether NPWT reduces all-cause mortality (NPWT: 25% versus Bogota bag: 35% (RR 0.71, 95% CI 0.27 to 1.88); very low-certainty evidence) or length of hospital stay compared with the Bogota bag (NPWT mean: 28.5 days versus Bogota bag mean: 27.4 days (MD 1.10 days, 95% CI -13.39 to 15.59); very low-certainty evidence). The study did not report the proportion of participants with successful primary fascial closure of the abdomen, participant health-related quality of life, reoperation rate, wound infection, or pain.\nNegative pressure wound therapy versus any other type of temporary abdominal closure\nThere were no randomised controlled trials comparing NPWT with any other type of temporary abdominal closure.\nComparison of different negative pressure wound therapy devices\nWe included one study (34 participants) comparing different types of NPWT systems (Suprasorb CNP system versus ABThera system). We are uncertain whether the Suprasorb CNP system increases the proportion of participants with successful primary fascial closure of the abdomen compared with the ABThera system (Suprasorb CNP system: 88.2% versus ABThera system: 70.6% (RR 0.80, 95% CI 0.56 to 1.14); very low-certainty evidence). We are also uncertain whether the Suprasorb CNP system reduces adverse events (fistulae formation, Suprasorb CNP system: 0% versus ABThera system: 23.5% (RR 0.11, 95% CI 0.01 to 1.92); very low-certainty evidence), all-cause mortality (Suprasorb CNP system: 5.9% versus ABThera system: 17.6% (RR 0.33, 95% CI 0.04 to 2.89); very low-certainty evidence), or reoperation rate compared with the ABThera system (Suprasorb CNP system: 100% versus ABThera system: 100% (RR 1.00, 95% CI 0.90 to 1.12); very low-certainty evidence). The study did not report the time to primary fascial closure of the abdomen, participant health-related quality of life, length of hospital stay, wound infection, or pain.\nAuthors' conclusions\nBased on the available trial data, we are uncertain whether NPWT has any benefit in primary fascial closure of the abdomen, adverse events (fistulae formation), all-cause mortality, or length of hospital stay compared with the Bogota bag. We are also uncertain whether the Suprasorb CNP system has any benefit in primary fascial closure of the abdomen, adverse events, all-cause mortality, or reoperation rate compared with the ABThera system. Further research evaluating these outcomes as well as participant health-related quality of life, wound infection, and pain outcomes is required. We will update this review when data from the large studies that are currently ongoing are available.\n\nGiven the provided abstract, please respond to the following query: \"What is an open abdomen?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sometimes a person's abdomen needs to be left open while it heals after surgery. However, high death rates are associated with leaving the abdomen open after surgery. Managing the open abdomen is a considerable burden for patients and doctors."
}
]
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query-laysum | 2519 | [
{
"role": "user",
"content": "Abstract: Background\nMalignant gastric outlet obstruction is the clinical and pathological consequence of cancerous disease causing a mechanical obstruction to gastric emptying. It usually occurs when malignancy is at an advanced stage; therefore, people have a limited life expectancy. It is of paramount importance to restore oral intake to improve quality of life for the person in a manner that has a minimal risk of complications and a short recovery period.\nObjectives\nTo assess the benefits and harms of endoscopic stent placement versus surgical palliation for people with symptomatic malignant gastric outlet obstruction.\nSearch methods\nIn May 2018 we searched the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase and Ovid CINAHL. We screened reference lists from included studies and review articles.\nSelection criteria\nWe included randomised controlled trials comparing stent placement with surgical palliation for people with gastric outlet obstruction secondary to malignant disease.\nData collection and analysis\nTwo review authors independently extracted study data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for binary outcomes, mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes and the hazard ratio (HR) for time-to-event outcomes. We performed meta-analyses where meaningful. We assessed the quality of evidence using GRADE criteria.\nMain results\nWe identified three randomised controlled trials with 84 participants. Forty-one participants underwent surgical palliation and 43 participants underwent duodenal stent placement. There may have been little or no difference in the technical success of the procedure (RR 0.98, 95% CI 0.88 to 1.09; low-quality evidence), or whether the time to resumption of oral intake was quicker for participants who had undergone duodenal stent placement (MD -3.07 days, 95% CI -4.76 to -1.39; low-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved all-cause mortality and median survival postintervention.\nThe time to recurrence of obstructive symptoms may have increased slightly following duodenal stenting (RR 5.08, 95% CI 0.96 to 26.74; moderate-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved serious and minor adverse events. The heterogeneity for adverse events was moderately high (serious adverse events: Chi² = 1.71; minor adverse events: Chi² = 3.08), reflecting the differences in definitions used and therefore, may have impacted the outcomes. The need for reintervention may have increased following duodenal stenting (RR 4.71, 95% CI 1.36 to 16.30; very low-quality evidence).\nThe length of hospital stay may have been shorter (by approximately 4 to 10 days) following stenting (MD -6.70 days, 95% CI -9.41 to -3.98; moderate-quality evidence).\nAuthors' conclusions\nThe use of duodenal stent placement in malignant gastric outlet obstruction has the benefits of a quicker resumption of oral intake and a reduced inpatient hospital stay; however, this is balanced by an increase in the recurrence of symptoms and the need for further intervention.\nIt is impossible to draw further conclusions on these and the other measured outcomes, primarily due to the low number of eligible studies and small number of participants which resulted in low-quality evidence. It was not possible to analyse the impact on quality of life each intervention had for these participants.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies with 84 participants compared a surgical operation to bypass the blockage with the placement of a duodenal stent to bridge the blockage. The evidence is current to May 2018."
}
]
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query-laysum | 2520 | [
{
"role": "user",
"content": "Abstract: Background\nThe clinical presentation of acute chest syndrome is similar whether due to infectious or non-infectious causes, thus antibiotics are usually prescribed to treat all episodes. Many different pathogens, including bacteria, have been implicated as causative agents of acute chest syndrome. There is no standardized approach to antibiotic therapy and treatment is likely to vary from country to country. Thus, there is a need to identify the efficacy and safety of different antibiotic treatment approaches for people with sickle cell disease suffering from acute chest syndrome. This is an update of a Cochrane Review first published in 2007, and most recently updated in 2015.\nObjectives\nTo determine whether an empirical antibiotic treatment approach (used alone or in combination):\n1. is effective for acute chest syndrome compared to placebo or standard treatment;\n2. is safe for acute chest syndrome compared to placebo or standard treatment;\nFurther objectives are to determine whether there are important variations in efficacy and safety:\n3. for different treatment regimens,\n4. by participant age, or geographical location of the clinical trials.\nSearch methods\nWe searched The Group's Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched the LILACS database (1982 to 23 October 2017), African Index Medicus (1982 to 23 October 2017) and trial registries (23 October 2017).\nDate of most recent search of the Haemoglobinopathies Trials Register: 10 July 2019.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials.\nData collection and analysis\nEach author intended to independently extract data and assess trial quality by standard Cochrane methodologies, but no eligible randomised controlled trials were identified.\nMain results\nFor this update, we were unable to find any randomised controlled trials on antibiotic treatment approaches for acute chest syndrome in people with sickle cell disease.\nAuthors' conclusions\nThis update was unable to identify randomised controlled trials on efficacy and safety of the antibiotic treatment approaches for people with sickle cell disease suffering from acute chest syndrome. While randomised controlled trials are needed to establish the optimum antibiotic treatment for this condition, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated.\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 the effects and safety of antibiotics (alone or in combination) as compared to other antibiotics, placebo (a 'dummy' treatment) or standard treatment. We wanted to know if the different antibiotic treatments were effective, if they were safe, and which doses worked best for treating acute chest syndrome in people with sickle cell disease. This is an update of a previously published Cochrane Review."
}
]
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query-laysum | 2521 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the third update of the original Cochrane Review published in July 2005 and updated previously in 2012 and 2016.\nCancer is a significant global health issue. Radiotherapy is a treatment modality for many malignancies, and about 50% of people having radiotherapy will be long-term survivors. Some will experience late radiation tissue injury (LRTI), developing months or years following radiotherapy. Hyperbaric oxygen therapy (HBOT) has been suggested as a treatment for LRTI based on the ability to improve the blood supply to these tissues. It is postulated that HBOT may result in both healing of tissues and the prevention of complications following surgery and radiotherapy.\nObjectives\nTo evaluate the benefits and harms of hyperbaric oxygen therapy (HBOT) for treating or preventing late radiation tissue injury (LRTI) compared to regimens that excluded HBOT.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 24 January 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effect of HBOT versus no HBOT on LRTI prevention or healing.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. survival from time of randomisation to death from any cause; 2. complete or substantial resolution of clinical problem; 3. site-specific outcomes; and 4. adverse events. Our secondary outcomes were 5. resolution of pain; 6. improvement in quality of life, function, or both; and 7. site-specific outcomes. We used GRADE to assess certainty of evidence.\nMain results\nEighteen studies contributed to this review (1071 participants) with publications ranging from 1985 to 2022. We added four new studies to this updated review and evidence for the treatment of radiation proctitis, radiation cystitis, and the prevention and treatment of osteoradionecrosis (ORN).\nHBOT may not prevent death at one year (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.47 to 1.83; I2 = 0%; 3 RCTs, 166 participants; low-certainty evidence). There is some evidence that HBOT may result in complete resolution or provide significant improvement of LRTI (RR 1.39, 95% CI 1.02 to 1.89; I2 = 64%; 5 RCTs, 468 participants; low-certainty evidence) and HBOT may result in a large reduction in wound dehiscence following head and neck soft tissue surgery (RR 0.24, 95% CI 0.06 to 0.94; I2 = 70%; 2 RCTs, 264 participants; low-certainty evidence). In addition, pain scores in ORN improve slightly after HBOT at 12 months (mean difference (MD) −10.72, 95% CI −18.97 to −2.47; I2 = 40%; 2 RCTs, 157 participants; moderate-certainty evidence).\nRegarding adverse events, HBOT results in a higher risk of a reduction in visual acuity (RR 4.03, 95% CI 1.65 to 9.84; 5 RCTs, 438 participants; high-certainty evidence). There was a risk of ear barotrauma in people receiving HBOT when no sham pressurisation was used for the control group (RR 9.08, 95% CI 2.21 to 37.26; I2 = 0%; 4 RCTs, 357 participants; high-certainty evidence), but no such increase when a sham pressurisation was employed (RR 1.07, 95% CI 0.52 to 2.21; I2 = 74%; 2 RCTs, 158 participants; high-certainty evidence).\nAuthors' conclusions\nThese small studies suggest that for people with LRTI affecting tissues of the head, neck, bladder and rectum, HBOT may be associated with improved outcomes (low- to moderate-certainty evidence). HBOT may also result in a reduced risk of wound dehiscence and a modest reduction in pain following head and neck irradiation. However, HBOT is unlikely to influence the risk of death in the short term. HBOT also carries a risk of adverse events, including an increased risk of a reduction in visual acuity (usually temporary) and of ear barotrauma on compression. Hence, the application of HBOT to selected participants may be justified.\nThe small number of studies and participants, and the methodological and reporting inadequacies of some of the primary studies included in this review demand a cautious interpretation. More information is required on the subset of disease severity and tissue type affected that is most likely to benefit from this therapy, the time for which we can expect any benefits to persist and the most appropriate oxygen dose. Further research is required to establish the optimum participant selection and timing of any therapy. An economic evaluation should also be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to January 2022."
}
]
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query-laysum | 2522 | [
{
"role": "user",
"content": "Abstract: Background\nDisease recurrence and progression remain major challenges for the treatment of non-muscle invasive bladder cancer. Narrow band imaging (NBI) is an optical enhancement technique that may improve resection of non-muscle invasive bladder cancer and thereby lead to better outcomes for people undergoing the procedure.\nObjectives\nTo assess the effects of NBI- and white light cystoscopy (WLC)-guided transurethral resection of bladder tumor (TURBT) compared to WLC-guided TURBT in the treatment of non-muscle invasive bladder cancer.\nSearch methods\nWe performed a comprehensive literature search of 10 databases, including the Cochrane Library, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, several clinical trial registries, and grey literature for published and unpublished studies, irrespective of language. The search was performed per an a priori protocol on 3 December 2021.\nSelection criteria\nWe included randomized controlled trials of participants with suspected or confirmed non-muscle invasive bladder cancer. Participants in the control group must have received WLC-guided TURBT alone (hereinafter simply referred to as 'WLC TURBT'). Participants in the intervention group had to have received NBI- and WLC-guided TURBT (hereinafter simply referred to as 'NBI + WLC TURBT').\nData collection and analysis\nTwo review authors independently selected studies for inclusion/exclusion, performed data extraction, and assessed risk of bias. We conducted meta-analysis on time-to-event and dichotomous data using a random-effects model in RevMan, according to Cochrane methods. We rated the certainty of evidence for each outcome according to the GRADE approach.\nPrimary outcomes were time to recurrence, time to progression, and the occurrence of a major adverse event, defined as a Clavien-Dindo III, IV, or V complication. Secondary outcomes included time to death from bladder cancer and the occurrence of a minor adverse event, defined as a Clavien-Dindo I or II complication.\nMain results\nWe included eight studies with a total of 2152 participants randomized to the standard WLC TURBT or to NBI + WLC TURBT. A total of 1847 participants were included for analysis.\nBased on limited confidence in the time-to-event data, we found that NBI + WLC TURBT may lower the risk of disease recurrence over time compared to WLC TURBT (hazard ratio 0.63, 95% CI 0.45 to 0.89; I2 = 53%; 6 studies, 1244 participants; low certainty of evidence). No studies examined disease progression as a time-to-event outcome or a dichotomous outcome. There may be little to no difference in the risk of a major adverse event between participants who underwent NBI + WLC TURBT and those who underwent WLC TURBT (risk ratio 1.77, 95% CI 0.79 to 3.96; 4 studies, 1385 participants; low certainty of evidence).\nNo studies examined death from bladder cancer as a time-to-event outcome or a dichotomous outcome. There may be little to no difference in the risk of a minor adverse event between participants who underwent NBI + WLC TURBT and those who underwent WLC TURBT (risk ratio 0.88, 95% CI 0.49 to 1.56; I2 = 61%; 4 studies, 1385 participants; low certainty of evidence).\nAuthors' conclusions\nCompared to WLC TURBT alone, NBI + WLC TURBT may lower the risk of disease recurrence over time while having little or no effect on the risks of major or minor adverse events.\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": "Due to certain flaws in the design of these clinical trials and some contradictory findings between trials, our confidence in these findings was low. With more research in the future, more reliable data may likely change these findings. The evidence is up to date to December 2021."
}
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query-laysum | 2523 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces patient opioid requirements and, in turn, reduces the incidence and severity of opioid-induced adverse events (AEs).\nObjectives\nTo assess the analgesic efficacy and adverse effects of single-dose intravenous diclofenac, compared with placebo or an active comparator, for moderate to severe postoperative pain in adults.\nSearch methods\nWe searched the following databases without language restrictions: the Cochrane Central Register of Controlled Trials (Cochrane Register of Studies Online), MEDLINE, and Embase on 22 May 2018. We checked clinical trials registers and reference lists of retrieved articles for additional studies.\nSelection criteria\nWe included randomized trials that compared a single postoperative dose of intravenous diclofenac with placebo or another active treatment, for treating acute postoperative pain in adults following any surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for review inclusion, assessed risk of bias, and extracted data.\nOur primary outcome was the number of participants in each arm achieving at least 50% pain relief over a four- and six-hour period.\nOur secondary outcomes were time to, and number of participants using rescue medication; withdrawals due to lack of efficacy, AEs, and for any cause; and number of participants experiencing any AE, serious AEs (SAEs), and NSAID-related AEs. We performed a post hoc analysis of opioid-related AEs, to enable indirect comparisons with other analyses of postoperative analgesics.\nFor subgroup analysis, we planned to analyze different doses and formulations of parenteral diclofenac separately.\nWe assessed the overall quality of the evidence for each outcome using GRADE and created two 'Summary of findings' tables.\nMain results\nWe included eight studies, involving 1756 participants undergoing various surgeries (dental, mixed minor, abdominal, and orthopedic), with 20 to 175 participants receiving intravenous diclofenac in each study. Mean study population ages ranged from 24.5 years to 54.5 years. Intravenous diclofenac doses varied among and within studies, ranging from 3.75 mg to 75 mg. Five studies assessed newer formulations of parenteral diclofenac that could be administered as an undiluted intravenous bolus. Most studies had an unclear risk of bias for several domains and a high risk of bias due to small sample size. The overall quality of evidence for each outcome was generally low for reasons including unclear risk of bias in studies, imprecision, and low event numbers.\nPrimary outcome\nThree studies (277 participants) produced a number needed to treat for an additional beneficial outcome (NNTB) for at least 50% of maximum pain relief versus placebo of 2.4 (95% confidence interval (CI) 1.9 to 3.1) over four hours (low-quality evidence). Four studies (436 participants) produced an NNTB of 3.8 versus placebo (95% CI 2.9 to 5.9) over six hours (low-quality evidence). No studies provided data for the comparison of intravenous diclofenac with another NSAID over four hours. At six hours there was no difference between intravenous diclofenac and another NSAID (low-quality evidence).\nSecondary outcomes\nFor secondary efficacy outcomes, intravenous diclofenac was generally superior to placebo and similar to other NSAIDs.\nFor time to rescue medication, comparison of intravenous diclofenac versus placebo demonstrated a median of 226 minutes for diclofenac versus 80 minutes for placebo (5 studies, 542 participants, low-quality evidence). There were insufficient data for pooled analysis for comparisons of diclofenac with another NSAID (very low-quality evidence).\nFor the number of participants using rescue medication, two studies (235 participants) compared diclofenac with placebo. The number needed to treat to prevent one additional harmful event (NNTp) (here, the need for rescue medication) compared with placebo was 3.0 (2.2 to 4.5, low-quality evidence). The comparison of diclofenac with another NSAID included only one study (98 participants). The NNTp was 4.5 (2.5 to 33) for ketorolac versus diclofenac (very low-quality evidence).\nThe numbers of participants withdrawing were generally low and inconsistently reported (very low-quality evidence). Participant withdrawals were: 6% (8/140) diclofenac versus 5% (7/128) placebo, and 9% (8/87) diclofenac versus 7% (6/82) another NSAID for lack of efficacy; 2% (4/211) diclofenac versus 0% (0/198) placebo, and 3% (4/138) diclofenac versus 2% (2/129) another NSAID due to AEs; and 11% (21/191) diclofenac versus 17% (30/179) placebo, and 18% (21/118) diclofenac versus 15% (17/111) another NSAID for any cause.\nOverall adverse event rates were similar between intravenous diclofenac and placebo (71% in both groups, 2 studies, 296 participants) and between intravenous diclofenac and another NSAID (55% and 58%, respectively, 2 studies, 265 participants) (low-quality evidence for both comparisons). Serious and specific AEs were rare, preventing meta-analysis.\nThere were sufficient data for a dose-effect analysis for our primary outcome for only one alternative dose, 18.75 mg. Analysis of the highest dose employed in each study demonstrated a relative benefit compared with placebo of 1.9 (1.4 to 2.4), whereas for the group receiving 18.75 mg, the relative benefit versus placebo was 1.6 (1.2 to 2.1, 2 studies). Compared to another NSAID, the high-dose analysis demonstrated a relative benefit of 0.9 (0.8 to 1.1), for the group receiving 18.75 mg, the relative benefit was 0.78 (0.65 to 0.93). For direct comparison of high dose versus 18.75 mg, the proportion of participants with at least 50% pain relief was 66% (90/137) for the high-dose arm versus 57% (77/135) in the low-dose arm. There were insufficient data for subgroup meta-analysis of different diclofenac formulations.\nAuthors' conclusions\nThe amount and quality of evidence for the use of intravenous diclofenac as a treatment for postoperative pain is low. The available evidence indicates that postoperative intravenous diclofenac administration offers good pain relief for the majority of patients, but further research may impact this estimate. Adverse events appear to occur at a similar rate to other NSAIDs. Insufficient information is available to assess whether intravenous diclofenac has a different rate of bleeding, renal dysfunction, or cardiovascular events versus other NSAIDs. There was insufficient information to evaluate the efficacy and safety of newer versus traditional formulations of intravenous diclofenac. There was a lack of studies in major and cardiovascular surgeries and in elderly populations, which may be at increased risk for adverse events.\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": "Pain is common in the short term after surgery. Non-steroidal anti-inflammatory drugs (NSAIDs, aspirin-like drugs) are often given along with opioids (such as morphine) to treat pain. However, NSAIDs may cause bleeding (e.g. at the site of an incision or wound) and injury to the kidneys and gut. Diclofenac is an NSAID that can be given by injection into a vein (intravenously), which may be useful when patients are not able to take medicines by mouth."
}
]
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query-laysum | 2524 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough conventional colonoscopy is the most accurate test available for the investigation of the colorectum for polyps, data exist that raise concerns about its sensitivity. Chromoscopy (spraying dye onto the surface of the colon to make polyps more visible) may be one way of enhancing the ability of colonoscopy to detect polyps, particularly diminutive flat lesions, which otherwise may be difficult to detect.\nObjectives\nTo determine whether the use of chromoscopy enhances the detection of polyps and neoplasia during endoscopic examination of the colon and rectum.\nSearch methods\nWe searched the following databases: Cochrane Colorectal Cancer Group Specialised Register (October 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library; Issue 10, 2015), MEDLINE (January 1950 to October 2015), EMBASE (January 1974 to October 2015), and ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (both November 2015). We also handsearched abstracts from relevant meetings from 1980 to 2015. Search terms included 'randomised trials' containing combinations of the following: 'chromoscopy' 'colonoscopy' 'dye-spray' 'chromo-endoscopy' 'indigo-carmine' 'magnifying endoscopy'.\nSelection criteria\nWe included all prospective randomised trials comparing chromoscopic with conventional endoscopic examination of the whole of the colon and rectum. We excluded studies of people with inflammatory bowel disease or polyposis syndromes and any studies that combined chromoscopy with additional interventions (cap assistance, water-perfused, etc.).\nData collection and analysis\nTwo review authors independently assessed the methodological quality of potentially eligible trials, and two review authors independently extracted data from the included trials. Outcome measures included the detection of polyps (neoplastic and non-neoplastic), the detection of diminutive lesions, the number of participants with multiple neoplastic lesions, and the extubation time.\nMain results\nWe included seven trials (2727 participants) in this update. Five trials were of sufficiently similar design to allow for pooled results. Two trials differed substantially in design and were included in a subgroup analysis. All the trials had some methodological drawbacks. However, combining the results showed a significant difference in favour of chromoscopy for all detection outcomes. In particular, chromoscopy was likely to yield significantly more people with at least one neoplastic lesion (odds ratio (OR) 1.53, 95% confidence interval (CI) 1.31 to 1.79; 7 trials; 2727 participants), and at least one diminutive neoplastic lesion (OR 1.51, 95% CI 1.19 to 1.92; 4 trials; 1757 participants). Significantly more people with three or more neoplastic lesions were also detected, but only when studies that used high-definition colonoscopy in the control group were excluded (OR 4.63, 95% CI 1.99 to 10.80; 2 trials; 519 participants). None of the included studies reported any adverse events related to the use of the contrast dye.\nAuthors' conclusions\nThere is strong evidence that chromoscopy enhances the detection of neoplasia in the colon and rectum. People with neoplastic polyps, particularly those with multiple polyps, are at increased risk of developing colorectal cancer. Such lesions, which presumably would be missed with conventional colonoscopy, could contribute to the interval cancer numbers on any surveillance programme.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to evaluate whether or not chromoscopy improves polyp detection in people undergoing screening for colorectal cancer."
}
]
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query-laysum | 2525 | [
{
"role": "user",
"content": "Abstract: Background\nSkin and soft-tissue infections (SSTIs) are common infections of the epidermis, dermis or subcutaneous tissue. SSTIs range in severity from minor, self-limiting, superficial infections to deep, aggressive, gangrenous, life-threatening infections. Some classifications divide SSTIs into 'complicated' and 'uncomplicated' infections based on clinical severity. Treatments of SSTIs involves antibiotic therapy, surgical debridement or drainage, and resuscitation if required. Sometimes these treatments are limited by high treatment costs, bacterial resistance to antibiotics and side effects, therefore, many people with SSTIs are turning to Chinese herbal medicines to treat this problem.\nChinese herbal medicines are natural substances that have been used for centuries in China where they are generally considered to be effective for SSTIs. Some Chinese herbal medicines have been shown to have antibacterial and anti-inflammatory properties, although a few herbal medicines have been reported to have side effects. Therefore there is a need to review the current clinical evidence systematically to inform current practice and guide future studies on Chinese herbal medicines for SSTIs.\nObjectives\nTo evaluate the benefits and harms of Chinese herbal medicines for treating skin and soft-tissue infections (SSTIs).\nSearch methods\nSearches were not restricted by date, language or publication status. In July 2014 we searched the following electronic databases: the Cochrane Wounds Group 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; Ovid AMED (Allied and Complementary Medicine); and EBSCO CINAHL.\nSelection criteria\nAll randomised controlled trials (RCTs) in people with SSTIs that compared Chinese herbal medicines with another intervention or control.\nData collection and analysis\nTwo review authors screened the literature search results independently; there were no disagreements.\nMain results\nWe identified no RCTs that met the inclusion criteria.\nAuthors' conclusions\nThere is currently no information available from RCTs to support or refute the use of Chinese herbal medicines in treating people with SSTIs.\n\nGiven the provided abstract, please respond to the following query: \"Why use Chinese herbal medicines for SSTIs?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In the Western world antibiotics are used to treat SSTIs, however antibiotics are expensive, can cause harms (side effects) as well as benefits, are not suitable for all people, and are becoming less effective as bacteria start to develop resistance to them. Alternative treatments need to be identified, and Chinese herbal medicines could provide that alternative."
}
]
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query-laysum | 2526 | [
{
"role": "user",
"content": "Abstract: Background\nInfertility is a prevalent problem that has significant consequences for individuals, families, and the community. Modifiable lifestyle factors may affect the chance of people with infertility having a baby. However, no guideline is available about what preconception advice should be offered. It is important to determine what preconception advice should be given to people with infertility and to evaluate whether this advice helps them make positive behavioural changes to improve their lifestyle and their chances of conceiving.\nObjectives\nTo assess the safety and effectiveness of preconception lifestyle advice on fertility outcomes and lifestyle behavioural changes for people with infertility.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, trial registers, Google Scholar, and Epistemonikos in January 2021; we checked references and contacted field experts to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), randomised cross-over studies, and cluster-randomised studies that compared at least one form of preconception lifestyle advice with routine care or attention control for people with infertility.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary effectiveness outcomes were live birth and ongoing pregnancy. Primary safety outcomes were adverse events and miscarriage. Secondary outcomes included reported behavioural changes in lifestyle, birth weight, gestational age, clinical pregnancy, time to pregnancy, quality of life, and male factor infertility outcomes. We assessed the overall quality of evidence using GRADE criteria.\nMain results\nWe included in the review seven RCTs involving 2130 participants. Only one RCT included male partners. Three studies compared preconception lifestyle advice on a combination of topics with routine care or attention control. Four studies compared preconception lifestyle advice on one topic (weight, alcohol intake, or smoking) with routine care for women with infertility and specific lifestyle characteristics. The evidence was of low to very low-quality. The main limitations of the included studies were serious risk of bias due to lack of blinding, serious imprecision, and poor reporting of outcome measures.\nPreconception lifestyle advice on a combination of topics versus routine care or attention control \nPreconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.79 to 1.10; 1 RCT, 626 participants), but the quality of evidence was low. No studies reported on adverse events or miscarriage. Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice on a combination of topics affects lifestyle behavioural changes: body mass index (BMI) (mean difference (MD) -1.06 kg/m², 95% CI -2.33 to 0.21; 1 RCT, 180 participants), vegetable intake (MD 12.50 grams/d, 95% CI -8.43 to 33.43; 1 RCT, 264 participants), alcohol abstinence in men (RR 1.08, 95% CI 0.74 to 1.58; 1 RCT, 210 participants), or smoking cessation in men (RR 1.01, 95% CI 0.91 to 1.12; 1 RCT, 212 participants). Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of women with adequate folic acid supplement use (RR 0.98, 95% CI 0.95 to 1.01; 2 RCTs, 850 participants; I² = 4%), alcohol abstinence (RR 1.07, 95% CI 0.99 to 1.17; 1 RCT, 607 participants), and smoking cessation (RR 1.01, 95% CI 0.98 to 1.04; 1 RCT, 606 participants), on low quality evidence. No studies reported on other behavioural changes.\nPreconception lifestyle advice on weight versus routine care \nStudies on preconception lifestyle advice on weight were identified only in women with infertility and obesity. Compared to routine care, we are uncertain whether preconception lifestyle advice on weight affects the number of live births (RR 0.94, 95% CI 0.62 to 1.43; 2 RCTs, 707 participants; I² = 68%; very low-quality evidence), adverse events including gestational diabetes (RR 0.78, 95% CI 0.48 to 1.26; 1 RCT, 317 participants; very low-quality evidence), hypertension (RR 1.07, 95% CI 0.66 to 1.75; 1 RCT, 317 participants; very low-quality evidence), or miscarriage (RR 1.50, 95% CI 0.95 to 2.37; 1 RCT, 577 participants; very low-quality evidence). Regarding lifestyle behavioural changes for women with infertility and obesity, preconception lifestyle advice on weight may slightly reduce BMI (MD -1.30 kg/m², 95% CI -1.58 to -1.02; 1 RCT, 574 participants; low-quality evidence). Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice affects the percentage of weight loss, vegetable and fruit intake, alcohol abstinence, or physical activity. No studies reported on other behavioural changes.\nPreconception lifestyle advice on alcohol intake versus routine care \nStudies on preconception lifestyle advice on alcohol intake were identified only in at-risk drinking women with infertility. We are uncertain whether preconception lifestyle advice on alcohol intake affects the number of live births (RR 1.15, 95% CI 0.53 to 2.50; 1 RCT, 37 participants; very low-quality evidence) or miscarriages (RR 1.31, 95% CI 0.21 to 8.34; 1 RCT, 37 participants; very low-quality evidence). One study reported on behavioural changes for alcohol consumption but not as defined in the review methods. No studies reported on adverse events or other behavioural changes.\nPreconception lifestyle advice on smoking versus routine care \nStudies on preconception lifestyle advice on smoking were identified only in smoking women with infertility. No studies reported on live birth, ongoing pregnancy, adverse events, or miscarriage. One study reported on behavioural changes for smoking but not as defined in the review methods.\nAuthors' conclusions\nLow-quality evidence suggests that preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births. Evidence was insufficient to allow conclusions on the effects of preconception lifestyle advice on adverse events and miscarriage and on safety, as no studies were found that looked at these outcomes, or the studies were of very low quality. This review does not provide clear guidance for clinical practice in this area. However, it does highlight the need for high-quality RCTs to investigate preconception lifestyle advice on a combination of topics and to assess relevant effectiveness and safety outcomes in men and women with infertility.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found seven studies in 2130 people with infertility. Only one study also included male partners. The studies were conducted in Canada, Iran, The Netherlands, UK, and USA. Three studies compared preconception lifestyle advice on a combination of topics with routine care or attention control. Four studies compared preconception lifestyle advice on one topic (weight, alcohol intake, or smoking) with routine care in women with infertility and specific lifestyle characteristics."
}
]
|
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