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query-laysum | 3033 | [
{
"role": "user",
"content": "Abstract: Background\nTraditional Chinese herbal medicine (TCHM) is widely used for treating vascular dementia (VaD) in China. Recent studies of a number of TCHMs have demonstrated in vitro biological activity and therapeutic effects in animals, but the published clinical evidence has not been systematically appraised.\nObjectives\nTo evaluate the efficacy and safety of TCHMs listed in either the Chinese Pharmacopoeia (CP) or the Chinese National Essential Drug List (NEDL) that are used to treat VaD. A secondary aim was to identify promising TCHMs for further clinical research.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group’s Specialised Register (on 14 March 2018) and also several Chinese biomedical databases: the Chinese Biological Medicine Database (January 1979 to May 2015), Wanfang database (January 1998 to May 2015), Chongqing VIP Information Co. Ltd or Weipu (January 1998 to May 2015) and the Chinese National Knowledge Infrastructure (January 1979 to May 2015).\nSelection criteria\nWe included randomised controlled trials (RCTs) of TCHMs compared to placebo, to Western medicine (WM) or to routine therapy for VaD risk factors. Eligible participants were men and women aged 18 years and above, diagnosed with VaD by any of the following four criteria: (1) Diagnostic and Statistical Manual of Mental Disorders (DSM) versions III, III-R, IV, IV-TR; (2) National Institute of Neurological Disorders and Stroke (NINDS-AIREN); (3) International Classification of Diseases 9 or 10; (4) the Hachinski or the Modified Hachinski Ischaemic Score. We required the use of an imaging technique to differentiate VaD from other dementias. We excluded (1) trials with participants diagnosed with mixed dementia or those that did not use an imaging technique to ascertain VaD; (2) trials of NEDL-listed Gingko biloba or Huperzine A as experimental interventions, to avoid duplication of existing Cochrane Reviews; (3) trials using acupuncture alone as the experimental intervention; (4) trials using another CP- or NEDL-listed TCHM (except for Huperzine A and Gingko which are popular in Western practice) as the control intervention; and (5) trials using purely non-pharmacological interventions as the control intervention unless explicitly described as 'routine therapy for VaD risk factors'.\nData collection and analysis\nWe assessed the risks of bias using the Cochrane 'Risk of bias' tool and adapted the Outcome Reporting Bias in Trials (ORBIT) classification system for outcome reporting bias. We assessed TCHM effects on five clinically important outcomes: cognition, global performance, safety, activities of daily living and behaviour and summarised the effects using mean differences for continuous outcomes and risk ratios or risk differences for binary outcomes. We stratified the studies into those that estimated the TCHM versus 'no treatment' effect and those that estimated the TCHM versus the WM effect, with further stratification by the specific TCHM tested or by one of the four modes of action. We pooled using a random-effects model. Due to substantial clinical and design heterogeneity, we did not estimate an 'overall TCHM effect'.\nMain results\nWe only found studies (47 studies, 3581 participants) for 18 of the 29 eligible TCHMs as defined by our inclusion criteria. All were superiority trials conducted in China between 1997 and 2013, with most employing a two-arm parallel design with sample sizes ranging from 26 to 240 and a median treatment duration of 12 weeks (range: 2 to 24 weeks).\nWe found that reporting and trial methodology were generally poor; in particular, there was a lack of information on randomisation, an absence of blinding of participants and outcome assessors and incomplete reporting of adverse events (AEs). None of the 30 trials published from 2007 onwards adopted the CONSORT recommendations for reporting RCTs of herbal interventions.\nWe found seven TCHMs which each had potentially large benefits in studies estimating the TCHM versus 'no treatment' effect and in studies estimating the TCHM versus the WM effect. Two TCHMs (NaoXinTong and TongXinLuo) were common to both groups. Three of these TCHMs – Nao XinTong, NaoMaiTai and TongXinLuo – had the strongest evidence to justify further research. Two TCHMs (NaoMaiTai and TongXinLuo) had a 5% or more increased risk of AEs compared to the 'no Treatment' control, but the quality of this evidence was poor.\nAuthors' conclusions\nWe found moderate- to very low-quality evidence of benefit and harm of TCHMs for VaD. Methodological inadequacies need to be addressed by better conducted and reported trials. We identified NaoMaiTai, NaoXinTong and TongXinLuo as warranting special research priority.\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": "Vascular dementia is a common form of dementia which is caused by problems with the blood supply to the brain. Some but not all people with vascular dementia have had strokes. There are no Western medicines licensed to treat vascular dementia. Traditional Chinese herbal medicines (TCHMs) are often used to treat it in China."
}
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query-laysum | 3034 | [
{
"role": "user",
"content": "Abstract: Background\nPrevention of chronic chagasic cardiomyopathy (CCC) by treating infected populations with trypanocidal therapy (TT) remains a challenge. Despite a renewed enthusiasm for TT, uncertainty regarding its efficacy, concerns about its safety and limited availability remain barriers for a wider use of conventional drugs. We have updated a previous version of this review.\nObjectives\nTo systematically search, appraise, identify and extract data from eligible studies comparing the outcome of cohorts of seropositive individuals to Trypanosoma cruzi exposed to TT versus placebo or no treatment.\nSearch methods\nWe sought eligible studies in electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL), Issue 1, 2014); MEDLINE (Ovid, 1946 to January week 5 2014); EMBASE (Ovid, 1980 to 2014 week 6) and LILACS (up to 6 May 2010)) by combining terms related with the disease and the treatment. The search also included a Google search, handsearch for references in review or selected articles, and search of expert files. We applied no language restrictions.\nSelection criteria\nReview authors screened the retrieved references for eligibility (those dealing with human participants treated with TT) and then assessed the pre-selected studies in full for inclusion. We included randomised controlled trials (RCTs) and observational studies that provided data on either mortality or clinical progression of CCC after at least four years of follow-up.\nData collection and analysis\nTeams of two review authors independently carried out the study selection, data extraction and risk of bias assessment, with a referee resolving disagreement within the pairs. Data collection included study design, characteristics of the population and interventions or exposures and outcome measures. We defined categories of outcome data as parasite-related (positive serology, xenodiagnosis or polymerase chain reaction (PCR) after TT) and participant-related (including efficacy outcomes such as progression towards CCC, all-cause mortality and side effects of TT). We reported pooled outcome data as Mantel-Haenszel odds ratios (OR) or standardised mean differences (SMD) along with 95% confidence intervals (CI), using a random-effects model. I2 statistics provided an estimate of heterogeneity across studies. We conducted an exploratory meta-regression analysis of the relationship between positive-serology and progression of CCC or mortality.\nMain results\nWe included 13 studies involving 4229 participants (six RCTs, n = 1096, five RCTs of intermediate risk of bias, one RCT of high risk of bias; four non-randomised experiments, n = 1639 and three observational studies, n = 1494). Ten studies tested nitroderivative drugs nifurtimox or benznidazole (three exposed participants to allopurinol, one to itraconazole). Five studies were conducted in Brazil, five in Argentina, one in Bolivia, one in Chile and one in Venezuela.\nTT was associated with substantial, but heterogeneous reductions on parasite-related outcomes such as positive serology (9 studies, OR 0.21, 95% CI 0.10 to 0.44, I2 = 76%), positive PCR (2 studies, OR 0.50, 95% CI 0.27 to 0.92, I2 = 0%), positive xenodiagnosis after treatment (6 studies, OR 0.35, 95% CI 0.14 to 0.86, I2 = 79%), or reduction on antibody titres (3 studies, SMD -0.56, 95% CI -0.89 to -0.23, I2 = 28%). Efficacy data on patient-related outcomes was largely from non-RCTs. TT with nitroderivatives was associated with potentially important, but imprecise and inconsistent reductions in progression of CCC (4 studies, 106 events, OR 0.74, 95% CI 0.32 to 1.73, I2 = 66%) and mortality after TT (6 studies, 99 events, OR 0.55, 95% CI 0.26 to 1.14, I2 = 48%). The overall median incidence of any severe side effects among 1475 individuals from five studies exposed to TT was 2.7%, and the overall discontinuation of this two-month therapy in RCTs (5 studies, 134 events) was 20.5% (versus 4.3% among controls) and 10.4% in other five studies (125 events).\nAuthors' conclusions\nDespite the evidence that TT reduced parasite-related outcomes, the low quality and inconsistency of the data for patient-important outcomes must be treated with caution. More geographically diverse RCTs testing newer forms of TT are warranted in order to 1. estimate efficacy more precisely, 2. explore factors potentially responsible for the heterogeneity of results and 3. increase knowledge on the efficacy/tolerance balance of conventional TT.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched scientific databases for studies comparing TT versus a placebo (an inactive or pretend treatment) or no treatment in people with Trypanosoma cruzi infection. The search is current to February 2014."
}
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query-laysum | 3035 | [
{
"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: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What is autologous platelet-rich plasma and is it useful for treating chronic wounds?"
}
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query-laysum | 3037 | [
{
"role": "user",
"content": "Abstract: Background\nRhegmatogenous retinal detachment (RRD) is a separation of neurosensory retina from the underlying retinal pigment epithelium. It is caused by retinal tears, which let fluid pass from the vitreous cavity to the subretinal space. Pars plana vitrectomy (PPV), scleral buckling surgery and pneumatic retinopexy are three accepted management strategies whose efficacy remains controversial. Pneumatic retinopexy is considered in a separate Cochrane Review.\nObjectives\nThe primary objective of this review was to assess the efficacy of PPV versus scleral buckling for the treatment of simple RRD (primary RRD of any extension with up to two clock hours large break(s) regardless of their anterior/posterior localisation) in people with (phakia) or without (aphakia) a natural lens in the eye, or with an artificial lens (pseudophakia). A secondary objective was to assess any data on economic and quality-of-life measures.\nSearch methods\nWe searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; MEDLINE; Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 5 December 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing PPV versus scleral buckling surgery with at least three months of follow-up.\nData collection and analysis\nWe used standard Cochrane methodology. Two review authors independently extracted the data and study characteristics from the studies identified as eligible after initial screening. We considered the following outcomes: primary retinal reattachment, postoperative visual acuity, final anatomical success, recurrence of retinal detachment, number of interventions needed to achieve final anatomical success, quality of life and adverse effects. We assessed the certainty of evidence using GRADE.\nMain results\nThis review included 10 RCTs (1307 eyes of 1307 participants) from Europe, India, Iran, Japan and Mexico, which compared PPV and scleral buckling for RRD repair. Two of these 10 studies compared PPV combined with scleral buckling with scleral buckling alone (54 participants). All studies were high or unclear risk of bias on at least one domain. Five studies were funded by non-commercial sources, while the other five studies did not report source of funding.\nThere was little or no difference in the proportion of participants who achieved retinal reattachment at least 3 months after the operation in the PPV group compared to those in the scleral buckling group (risk ratio (RR) 1.07, 95% confidence intervals (CI) 0.98 to 1.16; 9 RCTs, 1261 participants, low-certainty evidence). Approximately 67 in every 100 people treated with scleral buckling had retinal reattachment by 3 to 12 months. Treatment with PPV may result in 4 more people with retinal reattachment in every 100 people treated (95% confidence interval (CI) 2 fewer to 11 more).\nThere was no evidence of any important difference in postoperative visual acuity between participants in the PPV group compared to those in the scleral buckling group (mean difference (MD) 0.00 logMAR, 95% CI -0.09 to 0.10, 6 RCTs, 1138 participants, low-certainty evidence).\nThere was little or no difference in final anatomical success between participants in the PPV group and scleral buckling group (RR 1.01, 95% CI 0.99 to 1.04, 9 RCTs, 1235 participants, low-certainty evidence). There were 94 out of 100 people treated with control (scleral buckling) that achieved final anatomical success compared to 96 out of 100 in the PPV group.\nRetinal redetachment was reported in fewer participants in the PPV group compared to the scleral buckling group (RR 0.75 (95% CI 0.59 to 0.96, 9 RCTs, 1320 participants, low-certainty evidence). Approximately 28 in every 100 people treated with scleral buckling had retinal detachment by 3 to 36 months. Treatment with PPV may result in seven fewer people with retinal detachment in every 100 people treated (95% CI 1 to 11 fewer).\nParticipants treated with PPV on average needed fewer interventions to achieve final anatomical success but the difference was small and data were skewed (MD -0.20, 95% CI -0.34 to -0.06, 2 RCTs, 682 participants, very low-certainty evidence).\nVery low-certainty evidence on quality of life suggested that more people in the PPV group were \"satisfied with vision\" compared with the scleral buckling group (RR 6.22, 95% CI 0.88 to 44.09, 1 RCT, 32 participants).\nAll included studies reported adverse effects, however, it was not always clear whether they were reported as number of participants or number of adverse effects. Cataract development or progression was more prevalent in the PPV group (RR 1.71, 95% CI 1.45 to 2.01), choroidal detachment was more prevalent in the scleral buckling group (RR 0.19, 95% CI 0.06 to 0.65) and new/iatrogenic breaks were observed only in the PPV group (RR 8.21, 95% CI 1.91 to 35.21). Estimates of the relative frequency of other adverse effects, including postoperative proliferative vitreoretinopathy, postoperative increase in intraocular pressure, development of cystoid macular oedema, macular pucker and strabismus were imprecise. Evidence for adverse effects was low-certainty evidence.\nAuthors' conclusions\nLow- or very low-certainty evidence indicates that there may be little or no difference between PPV and scleral buckling in terms of primary success rate, visual acuity gain and final anatomical success in treating primary RRD. Low-certainty evidence suggests that there may be less retinal redetachment in the PPV group. Some adverse events appeared to be more common in the PPV group, such as cataract progression and new iatrogenic breaks, whereas others were more commonly seen in the scleral buckling group such as choroidal detachment.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The Cochrane Review authors searched for studies that had been published up to 5 December 2018."
}
]
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query-laysum | 3038 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.\nChronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. The use of topical (intranasal) corticosteroids has been widely advocated for the treatment of chronic rhinosinusitis given the belief that inflammation is a major component of this condition.\nObjectives\nTo assess the effects of intranasal corticosteroids in people with chronic rhinosinusitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.\nSelection criteria\nRandomised controlled trials (RCTs) with a follow-up period of at least three months comparing intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) against placebo or no treatment in patients with chronic rhinosinusitis.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation or other systemic adverse events. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 18 RCTs with a total of 2738 participants. Fourteen studies had participants with nasal polyps and four studies had participants without nasal polyps. Only one study was conducted in children.\nIntranasal corticosteroids versus placebo or no intervention\nOnly one study (20 adult participants without polyps) measured our primary outcome disease-specific HRQL using the Rhinosinusitis Outcome Measures-31 (RSOM-31). They reported no significant difference (numerical data not available) (very low quality evidence).\nOur second primary outcome, disease severity , was measured using the Chronic Sinusitis Survey in a second study (134 participants without polyps), which found no important difference (mean difference (MD) 2.84, 95% confidence interval (CI) -5.02 to 10.70; scale 0 to 100). Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI 1.76 to 4.40; 109 participants). The quality of the evidence was low.\nSix studies provided data on at least two of the individualsymptoms used in the EPOS 2012 criteria to define chronic rhinosinusitis (nasal blockage, rhinorrhoea, loss of sense of smell and facial pain/pressure). When all four symptoms in the EPOS criteria were available on a scale of 0 to 3 (higher = more severe symptoms), the average MD in change from baseline was -0.26 (95% CI -0.37 to -0.15; 243 participants; two studies; low quality evidence). Although there were more studies and participants when only nasal blockage and rhinorrhoea were considered (MD -0.31, 95% CI -0.38 to -0.24; 1702 participants; six studies), the MD was almost identical to when loss of sense of smell was also considered (1345 participants, four studies; moderate quality evidence).\nWhen considering the results for the individual symptoms, benefit was shown in the intranasal corticosteroids group. The effect size was larger for nasal blockage (MD -0.40, 95% CI -0.52 to -0.29; 1702 participants; six studies) than for rhinorrhoea (MD -0.25, 95% CI -0.33 to -0.17; 1702 participants; six studies) or loss of sense of smell (MD -0.19, 95% CI -0.28 to -0.11; 1345 participants; four studies). There was heterogeneity in the analysis for facial pain/pressure (MD -0.27, 95% CI -0.56 to 0.02; 243 participants; two studies). The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure.\nThere was an increased risk of epistaxis with intranasal corticosteroids (risk ratio (RR) 2.74, 95% CI 1.88 to 4.00; 2508 participants; 13 studies; high quality evidence).\nConsidering our secondary outcome, general HRQL, one study (134 participants without polyps) measured this using the SF-36 and reported a statistically significant benefit only on the general health subscale. The quality of the evidence was very low.\nIt is unclear whether there is a difference in the risk of local irritation (RR 0.94, 95% CI 0.53 to 1.64; 2124 participants; 11 studies) (low quality evidence).\nNone of the studies treated or followed up patients long enough to provide meaningful data on the risk of osteoporosis or stunted growth (children).\nOther comparisons\nWe identified no other studies that compared intranasal corticosteroids plus co-intervention A versus placebo plus co-intervention A.\nAuthors' conclusions\nMost of the evidence available was from studies in patients with chronic rhinosinusitis with nasal polyps. There is little information about quality of life (very low quality evidence). For disease severity, there seems to be improvement for all symptoms (low quality evidence), a moderate-sized benefit for nasal blockage and a small benefit for rhinorrhoea (moderate quality evidence). The risk of epistaxis is increased (high quality evidence), but these data included all levels of severity; small streaks of blood may not be a major concern for patients. It is unclear whether there is a difference in the risk of local irritation (low quality evidence).\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study (20 participants) reported no statistically significant difference in disease-specific health-related quality of life. Another measured general health-related quality of life and reported a statistically significant benefit only on a subscale for general health. Both studies recruited participants with chronic rhinosinusitis without nasal polyps. The quality of the evidence was very low (we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect).\nDisease severity was measured in one study (chronic rhinosinusitis without nasal polyps, 134 participants), which found no important difference. Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group. The quality of the evidence was low (our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect).\nWhen each type of symptom was measured separately (nasal blockage, rhinorrhoea, loss of sense of smell, facial pain/pressure), benefit was shown in the intranasal corticosteroids group. The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure (moderate quality evidence means we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different).\nThere was an increased risk of nosebleeds (epistaxis) with intranasal corticosteroids (high quality evidence). However, it was unclear whether there was a difference in the risk of local (nose or throat) irritation (low quality evidence).\nNone of the studies treated or followed up patients long enough to provide meaningful data on the risk of osteoporosis (fragile bones) or stunted growth (in children)."
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query-laysum | 3039 | [
{
"role": "user",
"content": "Abstract: Background\nBreakdown of the developmentally immature epidermal barrier may permit entry for micro-organisms leading to invasive infection in preterm infants. Topical emollients may improve skin integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in preterm infants.\nObjectives\nTo assess the effect of topical application of emollients (ointments, creams, or oils) on the risk of invasive infection and mortality in preterm infants.\nSearch methods\nWe searched CENTRAL via Cochrane Register of Studies (CRS) Web and MEDLINE via Ovid (updated 08 January 2021) and the reference lists of retrieved articles.\nSelection criteria\nRandomised or quasi-randomised controlled trials that assessed the effect of prophylactic application of topical emollient on the risk of invasive infection, mortality, other morbidity, and growth and development in preterm infants.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. Two review authors separately evaluated trial quality, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of evidence for effects on mortality and invasive infection.\nMain results\nWe included 22 trials with a total of 5578 infant participants. The main potential sources of bias were lack of clarity on the methods used to generate random sequences and conceal allocation in half of the trials, and lack of masking of parents, caregivers, clinicians, and investigators in all of the trials.\nEight trials (2086 infants) examined the effect of topical ointments or creams. Most participants were very preterm infants cared for in healthcare facilities in high-income countries. Meta-analyses suggested that topical ointments or creams may have little or no effect on invasive infection (RR 1.13, 95% confidence interval (CI) 0.97 to 1.31; low certainty evidence) or mortality (RR 0.94, 95% CI 0.82 to 1.08; low certainty evidence).\nFifteen trials (3492 infants) assessed the effect of topical plant or vegetable oils. Most of these trials were undertaken in low- or middle-income countries and were based in healthcare facilities. One large (2249 infants) community-based trial occurred in a rural field practice in India. Meta-analyses suggested that topical oils may reduce invasive infection (RR 0.71, 95% CI 0.52 to 0.96; I² = 52%; low certainty evidence) but have little or no effect on mortality (RR 0.94, 95% CI 0.82 to 1.08, I² = 3%; low certainty evidence).\nOne trial (316 infants) that compared petroleum-based ointment versus sunflower seed oil in very preterm infants in Bangladesh showed little or no effect on invasive infection (RR 0.91, 95% CI 0.57 to 1.46; low certainty evidence), but suggested that ointment may lower mortality slightly (RR 0.82, 95% CI 0.68 to 0.98; RD -0.12, 95% CI -0.23 to -0.01; number needed to treat for an additional beneficial outcome 8, 95% CI 4 to 100; low certainty evidence). One trial (64 infants) that assessed the effect of coconut oil versus mineral oil in preterm infants with birth weight 1500 g to 2000 g in India reported no episodes of invasive infection or death in either group (very low certainty evidence).\nAuthors' conclusions\nThe level of certainty about the effects of emollient therapy on invasive infection or death in preterm infants is low. Since these interventions are mostly inexpensive, readily accessible, and generally acceptable, further good-quality randomised controlled trials in healthcare facilities, and in community settings in low- or middle-income countries, may be justified.\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": "Our search (updated January 2021) identified 22 eligible trials. In total, 5578 infants participated. Eight trials (2086 infants) examined the effect of topical ointments or creams in very preterm infants (born more than eight weeks early) cared for in hospitals, mostly in high-income countries. Fourteen trials (3492 infants) assessed the effect of sunflower and other vegetable oils, mostly in low- or middle-income countries in south Asia. All but one of these trials was conducted in hospitals. One large trial in India (2249 infants) was based in the community."
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query-laysum | 3040 | [
{
"role": "user",
"content": "Abstract: Background\nLand-based exercise therapy is recommended in clinical guidelines for hip or knee osteoarthritis. Adjunctive non-pharmacological therapies are commonly used alongside exercise in hip or knee osteoarthritis management, but cumulative evidence for adjuncts to land-based exercise therapy is lacking.\nObjectives\nTo evaluate the benefits and harms of adjunctive therapies used in addition to land-based exercise therapy compared with placebo adjunctive therapy added to land-based exercise therapy, or land-based exercise therapy only for people with hip or knee osteoarthritis.\nSearch methods\nWe searched CENTRAL, MEDLINE, PsycINFO, EMBASE, CINAHL, Physiotherapy Evidence Database (PEDro) and clinical trials registries up to 10 June 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs of people with hip or knee osteoarthritis comparing adjunctive therapies alongside land-based exercise therapy (experimental group) versus placebo adjunctive therapies alongside land-based exercise therapy, or land-based exercise therapy (control groups). Exercise had to be identical in both groups. Major outcomes were pain, physical function, participant-reported global assessment, quality of life (QOL), radiographic joint structural changes, adverse events and withdrawals due to adverse events. We evaluated short-term (6 months), medium-term (6 to 12 months) and long-term (12 months onwards) effects.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed risk of bias and certainty of evidence for major outcomes using GRADE.\nMain results\nWe included 62 trials (60 RCTs and 2 quasi-RCTs) totalling 6508 participants. One trial included people with hip osteoarthritis, one hip or knee osteoarthritis and 60 included people with knee osteoarthritis only. Thirty-six trials evaluated electrophysical agents, seven manual therapies, four acupuncture or dry needling, or taping, three psychological therapies, dietary interventions or whole body vibration, two spa or peloid therapy and one foot insoles. Twenty-two trials included a placebo adjunctive therapy. We presented the effects stratified by different adjunctive therapies along with the overall results. We judged most trials to be at risk of bias, including 55% at risk of selection bias, 74% at risk of performance bias and 79% at risk of detection bias. Adverse events were reported in 11 (18%) trials.\nComparing adjunctive therapies plus land-based exercise therapy against placebo therapies plus exercise up to six months (short-term), we found low-certainty evidence for reduced pain and function, which did not meet our prespecified threshold for a clinically important difference. Mean pain intensity was 5.4 in the placebo group on a 0 to 10 numerical pain rating scale (NPRS) (lower scores represent less pain), and 0.77 points lower (0.48 points better to 1.16 points better) in the adjunctive therapy and exercise therapy group; relative improvement 10% (6% to 15% better) (22 studies; 1428 participants). Mean physical function on the Western Ontario and McMaster (WOMAC) 0 to 68 physical function (lower scores represent better function) subscale was 32.5 points in the placebo group and reduced by 5.03 points (2.57 points better to 7.61 points better) in the adjunctive therapy and exercise therapy group; relative improvement 12% (6% better to 18% better) (20 studies; 1361 participants). Moderate-certainty evidence indicates that adjunctive therapies did not improve QOL (SF-36 0 to 100 scale, higher scores represent better QOL). Placebo group mean QOL was 81.8 points, and 0.75 points worse (4.80 points worse to 3.39 points better) in the placebo adjunctive therapy group; relative improvement 1% (7% worse to 5% better) (two trials; 82 participants). Low-certainty evidence (two trials; 340 participants) indicates adjunctive therapies plus exercise may not increase adverse events compared to placebo therapies plus exercise (31% versus 13%; risk ratio (RR) 2.41, 95% confidence interval (CI) 0.27 to 21.90). Participant-reported global assessment was not measured in any studies.\nCompared with land-based exercise therapy, low-certainty evidence indicates that adjunctive electrophysical agents alongside exercise produced short-term (0 to 6 months) pain reduction of 0.41 points (0.17 points better to 0.63 points better); mean pain in the exercise-only group was 3.8 points and 0.41 points better in the adjunctive therapy plus exercise group (0 to 10 NPRS); relative improvement 7% (3% better to 11% better) (41 studies; 3322 participants). Mean physical function (0 to 68 WOMAC subscale) was 18.2 points in the exercise group and 2.83 points better (1.62 points better to 4.04 points better) in the adjunctive therapy plus exercise group; relative improvement 9% (5% better to 13% better) (41 studies; 3323 participants). These results are not clinically important. Mean QOL in the exercise group was 56.1 points and 1.04 points worse in the adjunctive therapies plus exercise therapy group (1.04 points worse to 3.12 points better); relative improvement 2% (2% worse to 5% better) (11 studies; 1483 participants), indicating no benefit (low-certainty evidence). Moderate-certainty evidence indicates that adjunctive therapies plus exercise probably result in a slight increase in participant-reported global assessment (short-term), with success reported by 45% in the exercise therapy group and 17% more individuals receiving adjunctive therapies and exercise (RR 1.37, 95% CI 1.15 to 1.62) (5 studies; 840 participants). One study (156 participants) showed little difference in radiographic joint structural changes (0.25 mm less, 95% CI -0.32 to -0.18 mm); 12% relative improvement (6% better to 18% better). Low-certainty evidence (8 trials; 1542 participants) indicates that adjunctive therapies plus exercise may not increase adverse events compared with exercise only (8.6% versus 6.5%; RR 1.33, 95% CI 0.78 to 2.27).\nAuthors' conclusions\nModerate- to low-certainty evidence showed no difference in pain, physical function or QOL between adjunctive therapies and placebo adjunctive therapies, or in pain, physical function, QOL or joint structural changes, compared to exercise only. Participant-reported global assessment was not reported for placebo comparisons, but there is probably a slight clinical benefit for adjunctive therapies plus exercise compared with exercise, based on a small number of studies. This may be explained by additional constructs captured in global measures compared with specific measures. Although results indicate no increased adverse events for adjunctive therapies used with exercise, these were poorly reported. Most studies evaluated short-term effects, with limited medium- or long-term evaluation. Due to a preponderance of knee osteoarthritis trials, we urge caution in extrapolating the findings to populations with hip osteoarthritis.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions and certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Additional therapies plus exercise therapy do not appear to offer meaningful improvements in pain, function, quality of life or overall change for people with hip or knee osteoarthritis compared with sham additional therapies plus land-based exercise therapy; or in pain, function, quality of life or changes on X-rays when compared with exercise therapy only. Compared with exercise therapy there is probably a clinical benefit in patient-reported overall change for additional therapies plus exercise therapy, based on a small number of studies. Our confidence in the evidence varies between moderate to little or no confidence for different outcomes. Although results indicate no increased adverse events from additional therapies used with exercise therapy, this was poorly reported. Most studies evaluated short-term effects, with limited medium- or long-term evaluation."
}
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query-laysum | 3041 | [
{
"role": "user",
"content": "Abstract: Background\nMammalian bites are a common presentation in emergency and primary healthcare facilities across the world. The World Health Organization recommends postponing the suturing of a bite wound but this has not been evaluated through a systematic review.\nObjectives\nTo assess the effects of primary closure compared with delayed closure or no closure for mammalian bite wounds.\nSearch methods\nIn July 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 which compared primary closure with delayed or no closure for traumatic wounds due to mammalian bite.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-text publications, applied the inclusion criteria, and extracted data. We pooled data using a random-effects model, as appropriate. We used the Cochrane 'Risk of bias' tool and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe found three trials (878 participants) that compared primary closure with no closure for dog bites and one trial (120 participants) that compared primary closure with delayed closure. No other mammalian bite studies were identified. The trials were from the UK (one trial), Greece (one trial) and China (two trials). Overall, participants from both sexes and all age groups were represented.\nWe are uncertain whether primary closure improves the proportion of wounds which are infection-free compared with no closure, as the certainty of evidence for this outcome was judged to be very low (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.97 to 1.05; 2 studies, 782 participants; I2 = 0%). We downgraded the evidence by one level for high risk of bias and two levels for imprecision. There is no clinically important difference in cosmesis (acceptable physical/cosmetic appearance) of dog bite wounds when primary closure is compared with no closure (mean difference (MD) -1.31, 95% CI -2.03 to -0.59; 1 study, 182 participants). The certainty of evidence for this outcome was judged to be moderate (we downgraded our assessment by one level for imprecision).\nWe are uncertain whether primary closure improves the proportion of dog bite wounds that are infection-free compared with delayed closure, as the evidence for this outcome was judged to be very low (RR 0.98, 95% CI 0.90 to 1.07; 1 study, 120 participants; I2 = 0%). We downgraded the evidence by one level for high risk of bias and two levels for imprecision.\nNone of the four trials reported any adverse outcomes such as death or rabies but they were, in any case, unlikely to have been large enough to have satisfactory power to provide precise estimates for these. Important outcomes like time to complete wound healing, proportion of wounds healed, and length of hospital stay were not evaluated.\nAuthors' conclusions\nAll the studies we identified concerned dog bites. There is no high-certainty evidence to support or refute existing recommendations concerning primary closure for dog bites. The potential benefits and harms of primary closure compared with delayed or no closure for mammalian bites remain uncertain and more robust trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Mammalian bite wounds from animals such as dogs, cats and monkeys are a common problem throughout the world. In developed countries, many bite wounds are caused by domestic pets. In lower-income countries bites can also be caused by wild animals. Dogs are generally responsible for the majority of bites. Bite wounds are at high risk of infection as microbes are transmitted into the wound from the animal's mouth. In lower-income countries these wound infections can lead to serious complications and in some cases death.\nThe first priorities when treating an animal bite are to stop the flow of blood from the wound, provide pain relief, and prevent infection. This can include appropriate vaccination against tetanus and rabies. It is often recommended that bite wounds are not stitched straight away if infection is suspected, as closing an infected wound could delay healing and be potentially fatal."
}
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query-laysum | 3042 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review that was originally published in 2014, Issue 2.\n\nThe presence of residual disease after primary debulking surgery is a highly significant prognostic factor in women with advanced ovarian cancer. In up to 60% of women, residual tumour of > 1 cm is left behind after primary debulking surgery (defined as suboptimal debulking). These women might have benefited from neoadjuvant chemotherapy (NACT) prior to interval debulking surgery instead of primary debulking surgery followed by chemotherapy. It is therefore important to select accurately those women who would best be treated with primary debulking surgery followed by chemotherapy from those who would benefit from NACT prior to surgery.\nObjectives\nTo determine if performing a laparoscopy, in addition to conventional diagnostic work-up, in women suspected of advanced ovarian cancer is accurate in predicting the resectability of disease.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 6) in the Cochrane Library; MEDLINE via Ovid, Embase via Ovid, MEDION and Science Citation Index and Conference Proceedings Citation Index (ISI Web of Science) to July 2018. We also checked references of identified primary studies and review articles.\nSelection criteria\nWe included studies that evaluated the diagnostic accuracy of laparoscopy to determine the resectability of disease in women who are suspected of advanced ovarian cancer and planned to receive primary debulking surgery.\nData collection and analysis\nPairs of review authors independently assessed the quality of included studies using QUADAS-2 and extracted data on study and participant characteristics, index test, target condition and reference standard. We extracted data for two-by-two tables and summarised these graphically. We calculated sensitivity and specificity and negative predictive values.\nMain results\nWe included 18 studies, reporting on 14 cohorts of women (including 1563 participants), of which one was a randomised controlled trial (RCT). Laparoscopic assessment suggested that disease was suitable for optimal debulking surgery (no macroscopic residual disease or residual disease < 1 cm (negative predictive values)) in 54% to 96% of women who had macroscopic complete debulking surgery (no visible disease at end of laparotomy) and in 69% to 100% of women who had optimal debulking surgery (residual tumour < 1 cm at end of laparotomy).\nOnly two studies avoided partial verification bias by operating on all women independent of laparoscopic findings, and provided data to calculate sensitivity and specificity. These two studies had no false positive laparoscopies (i.e. no women had a laparoscopy indicating unresectable disease and then went on to have optimal debulking surgery (no disease > 1 cm remaining)).\nDue to the large heterogeneity pooling of the data was not possible for meta-analysis.\nAuthors' conclusions\nLaparoscopy may be a useful tool to identify those women who have unresectable disease, as no women were inappropriately unexplored. However, some women had suboptimal primary debulking surgery, despite laparoscopy predicting optimal debulking and data are at high risk of verification bias as only two studies performed the reference standard (debulking laparotomy) in test (laparoscopy)-positive women. Using a prediction model does not increase the sensitivity and will result in more unnecessarily explored women, due to a lower specificity.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to investigate if laparoscopy (keyhole surgery to look inside the abdominal cavity) is accurate in predicting whether a women can be successfully operated to remove of all visible tumour or at least to leave no tumour deposits larger than 1 cm. If so, this could help to avoid operating on those women who would be better treated with chemotherapy first."
}
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query-laysum | 3043 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic, hip, and long bone fractures can result in significant bleeding at the time of injury, with further blood loss if they are treated with surgical fixation. People undergoing surgery are therefore at risk of requiring a blood transfusion and may be at risk of peri-operative anaemia. Pharmacological interventions for blood conservation may reduce the risk of requiring an allogeneic blood transfusion and associated complications.\nObjectives\nTo assess the effectiveness of different pharmacological interventions for reducing blood loss in definitive surgical fixation of the hip, pelvic, and long bones.\nSearch methods\nWe used a predefined search strategy to search CENTRAL, MEDLINE, PubMed, Embase, CINAHL, Transfusion Evidence Library, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) from inception to 7 April 2022, without restrictions on language, year, or publication status.\nWe handsearched reference lists of included trials to identify further relevant trials. We contacted authors of ongoing trials to acquire any unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) of people who underwent trauma (non-elective) surgery for definitive fixation of hip, pelvic, and long bone (pelvis, tibia, femur, humerus, radius, ulna and clavicle) fractures only. There were no restrictions on gender, ethnicity, or age.\nWe excluded planned (elective) procedures (e.g. scheduled total hip arthroplasty), and studies published since 2010 that had not been prospectively registered.\nEligible interventions included: antifibrinolytics (tranexamic acid, aprotinin, epsilon-aminocaproic acid), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants, and non-fibrin sealants.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE. We did not perform a network meta-analysis due to lack of data.\nMain results\nWe included 13 RCTs (929 participants), published between 2005 and 2021. Three trials did not report any of our predefined outcomes and so were not included in quantitative analyses (all were tranexamic acid versus placebo).\nWe identified three comparisons of interest: intravenous tranexamic acid versus placebo; topical tranexamic acid versus placebo; and recombinant factor VIIa versus placebo. We rated the certainty of evidence as very low to low across all outcomes.\nComparison 1. Intravenous tranexamic acid versus placebo\nIntravenous tranexamic acid compared to placebo may reduce the risk of requiring an allogeneic blood transfusion up to 30 days (RR 0.48, 95% CI 0.34 to 0.69; 6 RCTs, 457 participants; low-certainty evidence) and may result in little to no difference in all-cause mortality (Peto odds ratio (Peto OR) 0.38, 95% CI 0.05 to 2.77; 2 RCTs, 147 participants; low-certainty evidence).\nIt may result in little to no difference in risk of participants experiencing myocardial infarction (risk difference (RD) 0.00, 95% CI −0.03 to 0.03; 2 RCTs, 199 participants; low-certainty evidence), and cerebrovascular accident/stroke (RD 0.00, 95% CI −0.02 to 0.02; 3 RCTs, 324 participants; low-certainty evidence).\nWe are uncertain if there is a difference between groups for risk of deep vein thrombosis (Peto OR 2.15, 95% CI 0.22 to 21.35; 4 RCTs, 329 participants, very low-certainty evidence), pulmonary embolism (Peto OR 1.08, 95% CI 0.07 to 17.66; 4 RCTs, 329 participants; very low-certainty evidence), and suspected serious drug reactions (RD 0.00, 95% CI −0.03 to 0.03; 2 RCTs, 185 participants; very low-certainty evidence).\nNo data were available for number of red blood cell units transfused, reoperation, or acute transfusion reaction.\nWe downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures), and upgraded the evidence for transfusion requirement for a large effect.\nComparison 2. Topical tranexamic acid versus placebo\nWe are uncertain if there is a difference between topical tranexamic acid and placebo for risk of requiring an allogeneic blood transfusion (RR 0.31, 95% CI 0.08 to 1.22; 2 RCTs, 101 participants), all-cause mortality (RD 0.00, 95% CI −0.10 to 0.10; 1 RCT, 36 participants), risk of participants experiencing myocardial infarction (Peto OR 0.15, 95% CI 0.00 to 7.62; 1 RCT, 36 participants), cerebrovascular accident/stroke (RD 0.00, 95% CI −0.06 to 0.06; 1 RCT, 65 participants); and deep vein thrombosis (Peto OR 1.11, 95% CI 0.07 to 17.77; 2 RCTs, 101 participants).\nAll outcomes reported were very low-certainty evidence.\nNo data were available for number of red blood cell units transfused, reoperation, incidence of pulmonary embolism, acute transfusion reaction, or suspected serious drug reactions.\nWe downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), inconsistency (moderate heterogeneity), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures, and high risk of attrition and reporting biases in one trial).\nComparison 3. Recombinant factor VIIa versus placebo\nOnly one RCT of 48 participants reported data for recombinant factor VIIa versus placebo, so we have not presented the results here.\nAuthors' conclusions\nWe cannot draw conclusions from the current evidence due to lack of data. Most published studies included in our analyses assessed the use of tranexamic acid (compared to placebo, or using different routes of administration).\nWe identified 27 prospectively registered ongoing RCTs (total target recruitment of 4177 participants by end of 2023). The ongoing trials create six new comparisons: tranexamic acid (tablet + injection) versus placebo; intravenous tranexamic acid versus oral tranexamic acid; topical tranexamic acid versus oral tranexamic acid; different intravenous tranexamic acid dosing regimes; topical tranexamic acid versus topical fibrin glue; and fibrinogen (injection) versus placebo.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We have little confidence in the evidence for some outcomes, and are not confident about the evidence for others. This is because it is possible that people in the studies were aware of which treatment they were getting, also, the studies were small, and did not all provide data about everything in which we were interested."
}
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query-laysum | 3044 | [
{
"role": "user",
"content": "Abstract: Background\nThere are a limited number of treatment options for patients with ulcerative colitis (UC). An increased risk of thrombosis in UC coupled with an observation that UC patients being treated with anticoagulant therapy for thrombotic events had an improvement in their bowel symptoms led to trials examining the use of unfractionated heparin (UFH) and low molecular weight heparins (LMWH) in patients with active UC.\nObjectives\nTo review randomized trials examining the efficacy of unfractionated heparin (UFH) or low molecular weight heparins (LMWH) for remission induction in patients with ulcerative colitis.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL, and the Cochrane IBD/FBD group specialized trials register up to June 2014. We also searched review papers on ulcerative colitis and references from identified papers in an effort to identify additional randomized trials studying UFH or LMWH use in patients with ulcerative colitis. We searched abstracts from major gastroenterological meetings to identify research published in abstract form.\nSelection criteria\nRandomized controlled trials comparing UFH or LMWH to placebo or a control therapy for induction of remission in ulcerative colitis were included. Studies published in abstract form only were included if the authors could be contacted for further information.\nData collection and analysis\nA data extraction form was developed and used to extract data from included studies. Two authors independently extracted data. Any disagreements were resolved by consensus. The Cochrane Risk of Bias tool was used to assess study quality. Data were analyzed on an intention-to-treat basis. The primary outcome was induction of remission, as defined by the studies. Secondary outcomes measures included: endoscopic remission as defined by the authors; clinical, histological or endoscopic improvement as defined by the authors; the occurrence of adverse events; the occurrence of bleeding; and improvements in quality of life as measured by a validated instrument. We calculated the risk ratio (RR) and corresponding 95% confidence interval for dichotomous outcomes. Data were combined for analysis if they assessed the same treatments (UFH or LMWH versus placebo or other therapy). The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nFive studies were eligible for inclusion (329 patients). Three studies (270 patients) compared low molecular weight heparin to placebo, one study (34 patients) compared LMWH in addition to standard therapy, and one study (25 patients) compared UFH to corticosteroids. The study comparing UFH to corticosteroids was rated at high risk of bias due to a single-blind design. The study that compared the addition of LMWH to standard therapy to standard therapy alone was rated at high risk of bias due to open-label design. The other three studies were rated as low risk of bias. LMWH administered subcutaneously showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), and clinical, endoscopic, or histological improvement. High dose LMWH administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission (RR 1.39; 95% CI 1.09 to 1.77 ; P = 0.008; very low quality of evidence), clinical improvement (RR 1.28; 95% CI 1.06 to 1.55; P = 0.01; very low quality of evidence), and endoscopic improvement (RR 1.21; 95% CI 1.00 to 1.47 ; P = 0.05) but not endoscopic remission or histologic improvement. LMWH was not beneficial when added to standard therapy for clinical remission, clinical improvement, endoscopic remission or endoscopic improvement. LMWH was well-tolerated but provided no significant benefit for quality of life. One study examining UFH versus corticosteroids for the treatment of severe UC demonstrated the inferiority of UFH for clinical improvement. More patients assigned to UFH had rectal hemorrhage as an adverse event.\nAuthors' conclusions\nThere is evidence to suggest that LMWH may be effective for the treatment of active UC. When administered by extended colon-release tablets, LMWH was more effective than placebo for treating outpatients with mild to moderate disease. This benefit needs to be confirmed by further randomized controlled studies. The same benefits were not seen when LMWH was administered subcutaneously at lower doses. There is no evidence to support the use of UFH for the treatment of active UC. A further trial of UFH in patients with mild disease may also be justified. Any benefit found would need to be weighed against a possible increased risk of rectal bleeding in patients with active UC.\n\nGiven the provided abstract, please respond to the following query: \"Key Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In one small study, unfractionated heparin was worse than steroids for inducing clinical improvement (i.e. reduction of symptoms) in people with severe ulcerative colitis. In addition, rectal bleeding was more frequent among people who received unfractionated heparin. In another small study low molecular weight heparin used with standard therapy provided no additional benefit over standard therapy alone in adults with active ulcerative colitis.\nLow molecular weight heparin administered by injection showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), clinical improvement and endoscopic improvement (i.e. healing of inflammation). High dose low molecular weight heparin administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission, clinical improvement. and endoscopic improvement. This result suggests that high dose low molecular weight heparin administered by extended-release capsules may be effective for the treatment of active ulcerative colitis. However, this result needs to be verified by future clinical trials."
}
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query-laysum | 3045 | [
{
"role": "user",
"content": "Abstract: Background\nMost of the detected increment in dental caries among children above the age of six years and adolescents is confined to occlusal surfaces of posterior permanent molars. Dental sealants and fluoride varnishes are much used to prevent caries. As the effectiveness of both interventions in controlling caries as compared with no intervention has been demonstrated previously, this review aimed to evaluate their relative effectiveness. It updates a review published originally in 2006 and updated in 2010 and in 2016.\nObjectives\nOur primary objective was to evaluate the relative effectiveness of dental sealants (i.e. fissure sealant) compared with fluoride varnishes, or fissure sealants plus fluoride varnishes compared with fluoride varnishes alone, for preventing dental caries in the occlusal surfaces of permanent teeth of children and adolescents.\nOur secondary objectives were to evaluate whether effectiveness is influenced by sealant material type and length of follow-up, document and report on data concerning adverse events associated with sealants and fluoride varnishes, and report the cost effectiveness of dental sealants versus fluoride varnish in caries prevention.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 19 March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 2), MEDLINE Ovid (1946 to 19 March 2020) and Embase Ovid (1980 to 19 March 2020). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication.\nSelection criteria\nWe included randomised controlled trials with at least 12 months of follow-up comparing fissure sealants, or fissure sealants plus fluoride varnishes, versus fluoride varnishes, for preventing caries in the occlusal surfaces of permanent posterior teeth (i.e. premolar or molar teeth), in participants younger than 20 years of age at the start of the study.\nData collection and analysis\nAt least two review authors independently screened search results, extracted data from included studies and assessed their risk of bias. We attempted to contact study authors to obtain missing or unclear information. We grouped and analysed studies on the basis of sealant material type: resin-based sealant or glass ionomer-based sealant (glass ionomer and resin-modified glass ionomer sealant), and different follow-up periods. We calculated the odds ratio (OR) for risk of caries on occlusal surfaces of permanent molar teeth. For trials with a split-mouth design, we used the Becker-Balagtas OR. One cluster-randomised trial provided precise estimates in terms of risk ratio (RR), which we used. For continuous outcomes and data, we used means and standard deviations to obtain mean differences (MD). For meta-analysis, we used the random-effects model when we combined data from four or more studies. We presented all measures with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria.\nMain results\nWe included 11 trials with 3374 participants aged five to 10 years when trials started. Three trials are new since the 2016 update. Two trials did not contribute data to our analysis.\nSealant versus fluoride varnish\nResin-based fissure sealants versus fluoride varnishes\nSeven trials evaluated this comparison (five contributing data). We are uncertain if resin-based sealants may be better than fluoride varnish, or vice versa, for preventing caries in first permanent molars at two to three years' follow-up (OR 0.67, 95% CI 0.37 to 1.19; I2 = 84%; 4 studies, 1683 children evaluated). One study measuring decayed, missing and filled permanent surfaces (DMFS) and decayed, missing and filled permanent teeth (DMFT) increment at two years suggested a small benefit for fissure sealant (DMFS MD –0.09, 95% CI –0.15 to –0.03; DMFT MD –0.08, 95% CI –0.14 to –0.02; 542 participants), though this may not be clinically significant. One small study, at high risk of bias, reported a benefit for sealant after four years in preventing caries (RR 0.42, 95% CI 0.21 to 0.84; 75 children) and at nine years (RR 0.48, 95% CI 0.29 to 0.79; 75 children). We assessed each of these results as having very low certainty.\nGlass ionomer-based sealants versus fluoride varnishes\nThree trials evaluated this comparison: one trial with chemically cured glass ionomer and two with resin-modified glass ionomer. Studies were clinically diverse, so we did not conduct a meta-analysis. In general, the studies found no benefit of one intervention over another at one, two and three years, although one study, which also included oral health education, suggested a benefit from sealants over varnish for children at high risk of caries. We assessed this evidence as very low certainty.\nSealant plus fluoride varnish versus fluoride varnish alone\nOne split-mouth trial analysing 92 children at two-year follow-up found in favour of resin-based fissure sealant plus fluoride varnish over fluoride varnish only (OR 0.30, 95% CI 0.17 to 0.55), which represented a clinically meaningful effect of a 77% reduction in caries after two years; however, we assessed this evidence as very low certainty.\nAdverse events\nFive trials (1801 participants) (four using resin-based sealant material and one using resin-modified glass ionomer) reported that no adverse events resulted from use of sealants or fluoride varnishes over one to nine years. The other studies did not mention adverse events.\nAuthors' conclusions\nApplying fluoride varnish or resin-based fissure sealants to first permanent molars helps prevent occlusal caries, but it has not been possible in this review to reach reliable conclusions about which one is better to apply. The available studies do not suggest either intervention is superior, but we assessed this evidence as having very low certainty. We found very low-certainty evidence that placing resin-based sealant as well as applying fluoride varnish works better than applying fluoride varnish alone. Fourteen studies are currently ongoing and their findings may allow us to draw firmer conclusions about whether sealants and varnish work equally well or whether one is better than the other.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the medical literature for randomised controlled studies (clinical studies where people are randomly put into one of two or more treatment groups), because these studies provide the most robust evidence about the effects of a treatment. We then compared the results, and summarised the evidence from all the studies. We assessed how certain the evidence was. To do this, we considered factors such as the way studies were conducted, study sizes and consistency of findings across studies. Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty."
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query-laysum | 3046 | [
{
"role": "user",
"content": "Abstract: Background\nEmbryo transfer (ET) is a crucial step of in vitro fertilisation (IVF) treatment, and involves placing the embryo(s) in the woman’s uterus. There is a negative association between endometrial wave-like activity (contractile activities) at the time of ET and clinical pregnancy, but no specific treatment is currently used in clinical practice to counteract their effects. Oxytocin is a hormone produced by the hypothalamus and released by the posterior pituitary. Its main role involves generating uterine contractions during and after childbirth. Atosiban is the best known oxytocin antagonist (and is also a vasopressin antagonist), and it is commonly used to delay premature labour by halting uterine contractions. Other oxytocin antagonists include barusiban, nolasiban, epelsiban, and retosiban. Administration of oxytocin antagonists around the time of ET has been proposed as a means to reduce uterine contractions that may interfere with embryo implantation. The intervention involves administering the medication before, during, or after the ET (or a combination).\nObjectives\nTo evaluate the effectiveness and safety of oxytocin antagonists around the time of ET in women undergoing assisted reproduction.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in March 2021; and checked references and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the use of oxytocin antagonists for women undergoing ET, compared with the non-use of this intervention, the use of placebo, or the use of another similar drug.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy and other adverse events.\nMain results\nWe included nine studies (including one comprising three separate trials, 3733 women analysed in total) investigating the role of three different oxytocin antagonists administered intravenously (atosiban), subcutaneously (barusiban), or orally (nolasiban). We found very low- to high-certainty evidence: the main limitations were serious risk of bias due to poor reporting of study methods, and serious or very serious imprecision.\nIntravenous atosiban versus normal saline or no intervention\nWe are uncertain of the effect of intravenous atosiban on live birth rate (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.88 to 1.24; 1 RCT, N = 800; low-certainty evidence). In a clinic with a live birth rate of 38% per cycle, the use of intravenous atosiban would be associated with a live birth rate ranging from 33.4% to 47.1%.\nWe are uncertain whether intravenous atosiban influences miscarriage rate (RR 1.08, 95% CI 0.75 to 1.56; 5 RCTs, N = 1424; I² = 0%; very low-certainty evidence). In a clinic with a miscarriage rate of 7.2% per cycle, the use of intravenous atosiban would be associated with a miscarriage rate ranging from 5.4% to 11.2%.\nIntravenous atosiban may increase clinical pregnancy rate (RR 1.50, 95% CI 1.18 to 1.89; 7 RCTs, N = 1646; I² = 69%; low-certainty evidence), and we are uncertain whether multiple or ectopic pregnancy and other complication rates were influenced by the use of intravenous atosiban (very low-certainty evidence).\nSubcutaneous barusiban versus placebo\nOne study investigated barusiban, but did not report on live birth or miscarriage.\nWe are uncertain whether subcutaneous barusiban influences clinical pregnancy rate (RR 0.96, 95% CI 0.69 to 1.35; 1 RCT, N = 255; very low-certainty evidence). Trialists reported more mild to moderate injection site reactions with barusiban than with placebo, but there was no difference in severe reactions. They reported no serious drug reactions; and comparable neonatal outcome between groups.\nOral nolasiban versus placebo\nNolasiban does not increase live birth rate (RR 1.13, 95% CI 0.99 to 1.28; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence). In a clinic with a live birth rate of 33% per cycle, the use of oral nolasiban would be associated with a live birth rate ranging from 32.7% to 42.2%.\nWe are uncertain of the effect of oral nolasiban on miscarriage rate (RR 1.45, 95% CI 0.73 to 2.88; 3 RCTs, N = 1832; I² = 0%; low-certainty evidence). In a clinic with a miscarriage rate of 1.5% per cycle, the use of oral nolasiban would be associated with a miscarriage rate ranging from 1.1% to 4.3%.\nOral nolasiban improves clinical pregnancy rate (RR 1.15, 95% CI 1.02 to 1.30; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence), and probably does not increase multiple or ectopic pregnancy, or other complication rates (moderate-certainty evidence).\nAuthors' conclusions\nWe are uncertain whether intravenous atosiban improves pregnancy outcomes for women undergoing assisted reproductive technology. This conclusion is based on currently available data from seven RCTs, which provided very low- to low-certainty evidence across studies.\nWe could draw no clear conclusions about subcutaneous barusiban, based on limited data from one RCT.\nFurther large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of atosiban and barusiban before ET.\nOral nolasiban appears to improve clinical pregnancy rate but not live birth rate, with an uncertain effect on miscarriage and adverse events. This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention.\n\nGiven the provided abstract, please respond to the following query: \"Medication given under the skin (barusiban) versus no medication\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There were no studies that reported live birth or miscarriage data for the use of barusiban. We are uncertain whether barusiban influences clinical pregnancy rates."
}
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query-laysum | 3047 | [
{
"role": "user",
"content": "Abstract: Background\nPrevious research has shown that the prophylactic use of uterotonic agents in the third stage of labour reduces postpartum blood loss and moderate to severe postpartum haemorrhage (PPH). PPH is defined as a blood loss of 500 mL or more within 24 hours after birth. This is one of a series of systematic reviews assessing the effects of prophylactic use of uterotonic drugs; in this review prophylactic ergot alkaloids as a whole, and different regimens of administration of ergot alkaloids, are compared with no uterotonic agents. This is an update of a Cochrane Review which was first published in 2007 and last updated in 2011.\nObjectives\nTo determine the effectiveness and safety of prophylactic use of ergot alkaloids in the third stage of labour by any route (intravenous (IV), intramuscular (IM), or oral) compared with no uterotonic agents, for the prevention of PPH.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (19 September 2017); we also searched reference lists of retrieved studies.\nSelection criteria\nWe included all randomised controlled trials or cluster-randomised trials comparing prophylactic ergot alkaloids by any route (IV, IM, or oral) with no uterotonic agents in the third stage of labour among women giving birth vaginally.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data and checked them for accuracy; they also assessed the risk of bias in included studies. Two review authors assessed the quality of the evidence using the GRADE approach.\nMain results\nThere were eight included studies: three studies had a low risk of bias and five studies had high risk of bias. The studies compared ergot alkaloids with no uterotonic agents, with a total of 2031 women in the ergot alkaloids group and 1978 women in the placebo or no treatment group. Seven studies used the IV/IM route of administration and one study used the oral route.\nErgot alkaloids (any route of administration) versus no uterotonic agents\nUse of ergot alkaloids in the third stage of labour decreased mean blood loss (mean difference (MD) -80.52 mL, 95% confidence interval (CI) -96.39 to -64.65 mL; women = 2718; studies = 3; moderate-quality evidence); decreased PPH of at least 500 mL (average risk ratio (RR) 0.52, 95% CI 0.28 to 0.94; women = 3708; studies = 5; I2 = 83%; low-quality evidence); increased maternal haemoglobin concentration (g/dL) at 24 to 48 hours postpartum (MD 0.50 g/dL, 95% CI 0.38 to 0.62; women = 1429; studies = 1; moderate-quality evidence); and decreased the use of therapeutic uterotonics (average RR 0.37, 95% CI 0.15 to 0.90; women = 2698; studies = 3; I2 = 89%; low-quality evidence). There were no clear differences between groups in severe PPH of at least 1000 mL (average RR 0.32, 95% CI 0.04 to 2.59; women = 1718; studies = 2; I2 = 74%; very low-quality evidence). The risk of retained placenta or manual removal of the placenta, or both, were inconsistent with high heterogeneity. Ergot alkaloids increased the risk of elevated blood pressure (average RR 2.60, 95% CI 1.03 to 6.57: women = 2559; studies = 3; low-quality evidence) and pain after birth requiring analgesia (RR 2.53, 95% CI 1.34 to 4.78: women = 1429; studies = 1; moderate-quality evidence) but there were no differences between groups in vomiting, nausea, headache or eclamptic fit.\nResults for IV/IM ergot alkaloids versus no uterotonic agents were similar to those for the main comparison of ergot alkaloids administered by any route, since most of the studies (seven of eight) used the IV/IM route. Only one small study (289 women) compared oral ergometrine with placebo and it showed no benefit of ergometrine over placebo. No maternal adverse effects were reported.\nNone of the studies reported on any of our prespecified neonatal outcomes\nAuthors' conclusions\nProphylactic IM or IV injections of ergot alkaloids may be effective in reducing blood loss, reducing PPH (estimated blood loss of at least 500 mL), and increasing maternal haemoglobin. Ergot alkaloids may also decrease the use of therapeutic uterotonics, but adverse effects may include elevated blood pressure and pain after birth requiring analgesia. There were no differences between groups in terms of other adverse effects (vomiting, nausea, headache or eclamptic fit). There is a lack of evidence on the effects of ergot alkaloids on severe PPH, and retained or manual removal of placenta. There is also a lack of evidence on the oral route of administration of ergot alkaloids.\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 previous systematic review showed that the combination of ergometrine and oxytocin was associated with a significantly lower postpartum haemorrhage (PPH) rate (defined as blood loss of at least 500 mL) but a greater incidence of side-effects compared to the use of oxytocin alone. However, there was no review comparing ergometrine with no uterotonic medications and different routes or timings of administration for the prevention of PPH."
}
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query-laysum | 3048 | [
{
"role": "user",
"content": "Abstract: Background\nClostridioides difficile (formerly known as Clostridium difficile) is a bacterium that can cause potentially life-threatening diarrheal illness in individuals with an unhealthy mixture of gut bacteria, known as dysbiosis, and can cause recurrent infections in nearly a third of infected individuals. The traditional treatment of recurrent C difficile infection (rCDI) includes antibiotics, which may further exacerbate dysbiosis. There is growing interest in correcting the underlying dysbiosis in rCDI using of fecal microbiota transplantation (FMT); and there is a need to establish the benefits and harms of FMT for the treatment of rCDI based on data from randomized controlled trials.\nObjectives\nTo evaluate the benefits and harms of donor-based fecal microbiota transplantation for the treatment of recurrent Clostridioides difficile infection in immunocompetent people.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 31 March 2022.\nSelection criteria\nWe considered randomized trials of adults or children with rCDI for inclusion. Eligible interventions must have met the definition of FMT, which is the administration of fecal material containing distal gut microbiota from a healthy donor to the gastrointestinal tract of a person with rCDI. The comparison group included participants who did not receive FMT and were given placebo, autologous FMT, no intervention, or antibiotics with activity against C difficile.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. proportion of participants with resolution of rCDI and 2. serious adverse events. Our secondary outcomes were 3. treatment failure, 4. all-cause mortality, 5. withdrawal from study, 6. rate of new CDI infection after a successful FMT, 7. any adverse event, 8. quality of life, and 9. colectomy. We used the GRADE criteria to assess certainty of evidence for each outcome.\nMain results\nWe included six studies with 320 participants. Two studies were conducted in Denmark, and one each in the Netherlands, Canada, Italy, and the US. Four were single-center and two were multicenter studies. All studies included only adults. Five studies excluded people who were severely immunocompromised, with only one study including 10 participants who were receiving immunosuppressive therapy out of the 64 enrolled; these were similarly distributed between the FMT arm (4/24 or 17%) and comparison arms (6/40 or 15%). The route of administration was the upper gastrointestinal tract via a nasoduodenal tube in one study, two studies used enema only, two used colonoscopic only delivery, and one used either nasojejunal or colonoscopic delivery, depending on a clinical determination of whether the recipient could tolerate a colonoscopy. Five studies had at least one comparison group that received vancomycin. The risk of bias (RoB 2) assessments did not find an overall high risk of bias for any outcome.\nAll six studies assessed the efficacy and safety of FMT for the treatment of rCDI.\nPooled results from six studies showed that the use of FMT in immunocompetent participants with rCDI likely leads to a large increase in resolution of rCDI in the FMT group compared to control (risk ratio (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71; P = 0.02, I2 = 63%; 6 studies, 320 participants; number needed to treat for an additional beneficial outcome (NNTB) 3; moderate-certainty evidence). Fecal microbiota transplantation probably results in a slight reduction in serious adverse events; however, the CIs around the summary estimate were wide (RR 0.73, 95% CI 0.38 to 1.41; P = 0.24, I² = 26%; 6 studies, 320 participants; NNTB 12; moderate-certainty evidence). Fecal microbiota transplantation may result in a reduction in all-cause mortality; however, the number of events was small, and the CIs of the summary estimate were wide (RR 0.57, 95% CI 0.22 to 1.45; P = 0.48, I2 = 0%; 6 studies, 320 participants; NNTB 20; low-certainty evidence). None of the included studies reported colectomy rates.\nAuthors' conclusions\nIn immunocompetent adults with rCDI, FMT likely leads to a large increase in the resolution of recurrent Clostridioides difficile infection compared to alternative treatments such as antibiotics. There was no conclusive evidence regarding the safety of FMT for the treatment of rCDI as the number of events was small for serious adverse events and all-cause mortality. Additional data from large national registry databases might be required to assess any short-term or long-term risks with using FMT for the treatment of rCDI. Elimination of the single study that included some immunocompromised people did not alter these conclusions. Due to the low number of immunocompromised participants enrolled, conclusions cannot be drawn about the risks or benefits of FMT for rCDI in the immunocompromised population.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found six clinical trials of 320 adults that met criteria for inclusion in this review that assessed the efficacy and safety of stool transplantation for the treatment of repeated C difficile infection. Two studies were conducted in Denmark, and one each in the Netherlands, Italy, Canada, and the US. The time of follow-up after the treatment with FMT ranged from eight weeks to 17 weeks. The amount of stool, route of administration, number of administrations, type of donor, and what type of treatment the comparison group received varied among the studies. Five studies excluded people who had weak immune systems (immunocompromised people); one study included people with weak immune systems and apparently normal immune systems (immunocompetent people)."
}
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query-laysum | 3049 | [
{
"role": "user",
"content": "Abstract: Background\nDiverticular disease is a common condition that increases in prevalence with age. Recent theories on the pathogenesis of diverticular inflammation have implicated chronic inflammation similar to that seen in ulcerative colitis. Mesalamine, or 5-aminosalicylic acid (5-ASA), is a mainstay of therapy for individuals with ulcerative colitis. Accordingly, 5-ASA has been studied for prevention of recurrent diverticulitis.\nObjectives\nTo evaluate the efficacy of mesalamine (5-ASA) for prevention of recurrent diverticulitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), in the Cochrane Library; Ovid MEDLINE (from 1950 to 9 September 2017); Ovid Embase (from 1974 to 9 September 2017); and two clinical trials registries for ongoing trials - Clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform database (9 September 2017).\nWe also searched proceedings from major gastrointestinal conferences - Digestive Disease Week (DDW), United European Gastroenterology Week (UEGW), and the American College of Gastroenterology (ACG) Annual Scientific Meeting - from 2010 to September 2017. In addition, we scanned reference lists from eligible publications, and we contacted corresponding authors to ask about additional trials.\nSelection criteria\nWe included randomised controlled clinical trials comparing the efficacy of 5-ASA versus placebo or another active drug for prevention of recurrent diverticulitis.\nData collection and analysis\nWe used standard methodological procedures as defined by Cochrane. Three review authors assessed eligibility for inclusion. Two review authors selected studies, extracted data, and assessed methodological quality independently. We calculated risk ratios (RRs) for prevention of diverticulitis recurrence using an intention-to-treat principle and random-effects models. We assessed heterogeneity using criteria for Chi2 (P < 0.10) and I2 tests (> 50%). To explore sources of heterogeneity, we conducted a priori subgroup analyses. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR vs odds ratio (OR)) and meta-analytical models (fixed-effect vs random-effects).\nMain results\nWe included in this review seven studies with a total of 1805 participants.\n\nWe judged all seven studies to have unclear or high risk of bias. Investigators found no evidence of an effect when comparing 5-ASA versus control for prevention of recurrent diverticulitis (31.3% vs 29.8%; RR 0.69, 95% confidence interval (CI) 0.43 to 1.09); very low quality of evidence).\nFive of the seven studies provided data on adverse events of 5-ASA therapy. The most commonly reported side effects were gastrointestinal symptoms (epigastric pain, nausea, and diarrhoea). No significant difference was seen between 5-ASA and control (67.8% vs 64.6%; RR 0.98, 95% CI 0.91 to 1.06; P = 0.63; moderate quality of evidence), nor was significant heterogeneity observed (I2 = 0%; P = 0.50).\nAuthors' conclusions\nThe effects of 5-ASA on recurrence of diverticulitis are uncertain owing to the small number of heterogenous trials included in this review. Rates of recurrent diverticulitis were similar among participants using 5-ASA and control participants. Effective medical strategies for prevention of recurrent diverticulitis are needed, and further randomised, double-blinded, placebo-controlled trials of rigorous design are warranted to specify the effects of 5-ASA (mesalamine) in the management of diverticulitis.\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 5-ASA prevented recurrence of diverticulitis."
}
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query-laysum | 3050 | [
{
"role": "user",
"content": "Abstract: Background\nShift work is associated with insufficient sleep, which can compromise worker alertness with ultimate effects on occupational health and safety. Adapting shift work schedules may reduce adverse occupational outcomes.\nObjectives\nTo assess the effects of shift schedule adaptation on sleep quality, sleep duration, and sleepiness among shift workers.\nSearch methods\nWe searched CENTRAL, PubMed, Embase, and eight other databases on 13 December 2020, and again on 20 April 2022, applying no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-RCTs, including controlled before-after (CBA) trials, interrupted time series, and cross-over trials. Eligible trials evaluated any of the following shift schedule components.\n• Permanency of shifts\n• Regularity of shift changes\n• Direction of shift rotation\n• Speed of rotation\n• Shift duration\n• Timing of start of shifts\n• Distribution of shift schedule\n• Time off between shifts\n• Split shifts\n• Protected sleep\n• Worker participation\nWe included studies that assessed sleep quality off-shift, sleep duration off-shift, or sleepiness during shifts.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of the records recovered by the search, read through the full-text articles of potentially eligible studies, and extracted data. We assessed the risk of bias of included studies using the Cochrane risk of bias tool, with specific additional domains for non-randomised and cluster-randomised studies. For all stages, we resolved any disagreements by consulting a third review author. We presented the results by study design and combined clinically homogeneous studies in meta-analyses using random-effects models. We assessed the certainty of the evidence with GRADE.\nMain results\nWe included 11 studies with a total of 2125 participants. One study was conducted in a laboratory setting and was not considered for drawing conclusions on intervention effects. The included studies investigated different and often multiple changes to shift schedule, and were heterogeneous with respect to outcome measurement.\nForward versus backward rotation\nThree CBA trials (561 participants) investigated the effects of forward rotation versus backward rotation. Only one CBA trial provided sufficient data for the quantitative analysis; it provided very low-certainty evidence that forward rotation compared with backward rotation did not affect sleep quality measured with the Basic Nordic Sleep Questionnaire (BNSQ; mean difference (MD) −0.20 points, 95% confidence interval (CI) −2.28 to 1.89; 62 participants) or sleep duration off-shift (MD −0.21 hours, 95% CI −3.29 to 2.88; 62 participants). However, there was also very low-certainty evidence that forward rotation reduced sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nFaster versus slower rotation\nTwo CBA trials and one non-randomised cross-over trial (341 participants) evaluated faster versus slower shift rotation. We were able to meta-analyse data from two studies. There was low-certainty evidence of no difference in sleep quality off-shift (standardised mean difference (SMD) −0.01, 95% CI −0.26 to 0.23) and very low-certainty evidence that faster shift rotation reduced sleep duration off-shift (SMD −0.26, 95% CI −0.51 to −0.01; 2 studies, 282 participants). The SMD for sleep duration translated to an MD of 0.38 hours' less sleep per day (95% CI −0.74 to −0.01). One study provided very low-certainty evidence that faster rotations decreased sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nLimited shift duration (16 hours) versus unlimited shift duration\nTwo RCTs (760 participants) evaluated 80-hour workweeks with maximum daily shift duration of 16 hours versus workweeks without any daily shift duration limits. There was low-certainty evidence that the 16-hour limit increased sleep duration off-shift (SMD 0.50, 95% CI 0.21 to 0.78; which translated to an MD of 0.73 hours' more sleep per day, 95% CI 0.30 to 1.13; 2 RCTs, 760 participants) and moderate-certainty evidence that the 16-hour limit reduced sleepiness during shifts, measured with the Karolinska Sleepiness Scale (SMD −0.29, 95% CI −0.44 to −0.14; which translated to an MD of 0.37 fewer points, 95% CI −0.55 to −0.17; 2 RCTs, 716 participants).\nShorter versus longer shifts\nOne RCT, one CBA trial, and one non-randomised cross-over trial (692 participants) evaluated shorter shift duration (eight to 10 hours) versus longer shift duration (two to three hours longer). There was very low-certainty evidence of no difference in sleep quality (SMD −0.23, 95% CI −0.61 to 0.15; which translated to an MD of 0.13 points lower on a scale of 1 to 5; 2 studies, 111 participants) or sleep duration off-shift (SMD 0.18, 95% CI −0.17 to 0.54; which translated to an MD of 0.26 hours' less sleep per day; 2 studies, 121 participants). The RCT and the non-randomised cross-over study found that shorter shifts reduced sleepiness during shifts, while the CBA study found no effect on sleepiness.\nMore compressed versus more spread out shift schedules\nOne RCT and one CBA trial (346 participants) evaluated more compressed versus more spread out shift schedules. The CBA trial provided very low-certainty evidence of no difference between the groups in sleep quality off-shift (MD 0.31 points, 95% CI −0.53 to 1.15) and sleep duration off-shift (MD 0.52 hours, 95% CI −0.52 to 1.56).\nAuthors' conclusions\nForward and faster rotation may reduce sleepiness during shifts, and may make no difference to sleep quality, but the evidence is very uncertain. Very low-certainty evidence indicated that sleep duration off-shift decreases with faster rotation. Low-certainty evidence indicated that on-duty workweeks with shift duration limited to 16 hours increases sleep duration, with moderate-certainty evidence for minimal reductions in sleepiness. Changes in shift duration and compression of workweeks had no effect on sleep or sleepiness, but the evidence was of very low-certainty. No evidence is available for other shift schedule changes. There is a need for more high-quality studies (preferably RCTs) for all shift schedule interventions to draw conclusions on the effects of shift schedule adaptations on sleep and sleepiness in shift workers.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to 13 December 2020."
}
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query-laysum | 3051 | [
{
"role": "user",
"content": "Abstract: Background\nHigh intracranial pressure (ICP) is the most frequent cause of death and disability after severe traumatic brain injury (TBI). It is usually treated with general maneuvers (normothermia, sedation, etc.) and a set of first-line therapeutic measures (moderate hypocapnia, mannitol, etc.). When these measures fail, second-line therapies are initiated, which include: barbiturates, hyperventilation, moderate hypothermia, or removal of a variable amount of skull bone (secondary decompressive craniectomy).\nObjectives\nTo assess the effects of secondary decompressive craniectomy (DC) on outcomes of patients with severe TBI in whom conventional medical therapeutic measures have failed to control raised ICP.\nSearch methods\nThe most recent search was run on 8 December 2019. We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic + Embase (OvidSP) and ISI Web of Science (SCI-EXPANDED & CPCI-S). We also searched trials registries and contacted experts.\nSelection criteria\nWe included randomized studies assessing patients over the age of 12 months with severe TBI who either underwent DC to control ICP refractory to conventional medical treatments or received standard care.\nData collection and analysis\nWe selected potentially relevant studies from the search results, and obtained study reports. Two review authors independently extracted data from included studies and assessed risk of bias. We used a random-effects model for meta-analysis. We rated the quality of the evidence according to the GRADE approach.\nMain results\nWe included three trials (590 participants). One single-site trial included 27 children; another multicenter trial (three countries) recruited 155 adults, the third trial was conducted in 24 countries, and recruited 408 adolescents and adults. Each study compared DC combined with standard care (this could include induced barbiturate coma or cooling of the brain, or both). All trials measured outcomes up to six months after injury; one also measured outcomes at 12 and 24 months (the latter data remain unpublished). All trials were at a high risk of bias for the criterion of performance bias, as neither participants nor personnel could be blinded to these interventions. The pediatric trial was at a high risk of selection bias and stopped early; another trial was at risk of bias because of atypical inclusion criteria and a change to the primary outcome after it had started.\nMortality: pooled results for three studies provided moderate quality evidence that risk of death at six months was slightly reduced with DC (RR 0.66, 95% CI 0.43 to 1.01; 3 studies, 571 participants; I2 = 38%; moderate-quality evidence), and one study also showed a clear reduction in risk of death at 12 months (RR 0.59, 95% CI 0.45 to 0.76; 1 study, 373 participants; high-quality evidence).\nNeurological outcome: conscious of controversy around the traditional dichotomization of the Glasgow Outcome Scale (GOS) scale, we chose to present results in three ways, in order to contextualize factors relevant to clinical/patient decision-making.\nFirst, we present results of death in combination with vegetative status, versus other outcomes. Two studies reported results at six months for 544 participants. One employed a lower ICP threshold than the other studies, and showed an increase in the risk of death/vegetative state for the DC group. The other study used a more conventional ICP threshold, and results favoured the DC group (15.7% absolute risk reduction (ARR) (95% CI 6% to 25%). The number needed to treat for one beneficial outcome (NNTB) (i.e. to avoid death or vegetative status) was seven. The pooled result for DC compared with standard care showed no clear benefit for either group (RR 0.99, 95% CI 0.46 to 2.13; 2 studies, 544 participants; I2 = 86%; low-quality evidence). One study reported data for this outcome at 12 months, when the risk for death or vegetative state was clearly reduced by DC compared with medical treatment (RR 0.68, 95% CI 0.54 to 0.86; 1 study, 373 participants; high-quality evidence).\nSecond, we assessed the risk of an 'unfavorable outcome' evaluated on a non-traditional dichotomized GOS-Extended scale (GOS-E), that is, grouping the category 'upper severe disability' into the 'good outcome' grouping. Data were available for two studies (n = 571). Pooling indicated little difference between DC and standard care regarding the risk of an unfavorable outcome at six months following injury (RR 1.06, 95% CI 0.69 to 1.63; 544 participants); heterogeneity was high, with an I2 value of 82%. One trial reported data at 12 months and indicated a clear benefit of DC (RR 0.81, 95% CI 0.69 to 0.95; 373 participants).\nThird, we assessed the risk of an 'unfavorable outcome' using the (traditional) dichotomized GOS/GOS-E cutoff into 'favorable' versus 'unfavorable' results. There was little difference between DC and standard care at six months (RR 1.00, 95% CI 0.71 to 1.40; 3 studies, 571 participants; low-quality evidence), and heterogeneity was high (I2 = 78%). At 12 months one trial suggested a similar finding (RR 0.95, 95% CI 0.83 to 1.09; 1 study, 373 participants; high-quality evidence).\nWith regard to ICP reduction, pooled results for two studies provided moderate quality evidence that DC was superior to standard care for reducing ICP within 48 hours (MD −4.66 mmHg, 95% CI −6.86 to −2.45; 2 studies, 182 participants; I2 = 0%). Data from the third study were consistent with these, but could not be pooled.\nData on adverse events are difficult to interpret, as mortality and complications are high, and it can be difficult to distinguish between treatment-related adverse events and the natural evolution of the condition. In general, there was low-quality evidence that surgical patients experienced a higher risk of adverse events.\nAuthors' conclusions\nDecompressive craniectomy holds promise of reduced mortality, but the effects of long-term neurological outcome remain controversial, and involve an examination of the priorities of participants and their families. Future research should focus on identifying clinical and neuroimaging characteristics to identify those patients who would survive with an acceptable quality of life; the best timing for DC; the most appropriate surgical techniques; and whether some synergistic treatments used with DC might improve patient outcomes.\n\nGiven the provided abstract, please respond to the following query: \"2. Good outcome (including moderate disability) versus death, vegetative state or serious disability\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "at six months there was no clear benefit for DC (2 studies), but at 12 months there was a clear benefit of DC (1 study)."
}
]
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query-laysum | 3052 | [
{
"role": "user",
"content": "Abstract: Background\nDegarelix is a gonadotropin-releasing hormone antagonist that leads to medical castration used to treat men with advanced or metastatic prostate cancer, or both. It is unclear how its effects compare to standard androgen suppression therapy.\nObjectives\nTo assess the effects of degarelix compared with standard androgen suppression therapy for men with advanced hormone-sensitive prostate cancer.\nSearch methods\nWe searched multiple databases (CENTRAL, MEDLINE, Embase, Scopus, Web of Science, LILACS until September 2020), trial registries (until October 2020), and conference proceedings (until December 2020). We identified other potentially eligible trials by reference checking, citation searching, and contacting study authors.\nSelection criteria\nWe included randomized controlled trials comparing degarelix with standard androgen suppression therapy for men with advanced prostate cancer.\nData collection and analysis\nThree review authors independently classified studies and abstracted data from the included studies. The primary outcomes were overall survival and serious adverse events. Secondary outcomes were quality of life, cancer-specific survival, clinical progression, other adverse events, and biochemical progression. We used a random-effects model for meta-analyses and assessed the certainty of evidence for the main outcomes according to GRADE.\nMain results\nWe included 11 studies with a follow-up of between three and 14 months. We also identified five ongoing trials.\nPrimary outcomes\nData to evaluate overall survival were not available.\nDegarelix may result in little to no difference in serious adverse events compared to standard androgen suppression therapy (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.62 to 1.05; low-certainty evidence; 2750 participants). Based on 114 serious adverse events in the standard androgen suppression group, this corresponds to 23 fewer serious adverse events per 1000 participants (43 fewer to 6 more). We downgraded the certainty of evidence for study limitations and imprecision.\nSecondary outcomes\nDegarelix likely results in little to no difference in quality of life assessed with a variety of validated questionnaires (standardized mean difference 0.06 higher, 95% CI 0.05 lower to 0.18 higher; moderate-certainty evidence; 2887 participants), with higher scores reflecting better quality of life. We downgraded the certainty of evidence for study limitations.\nData to evaluate cancer-specific survival were not available.\nThe effects of degarelix on cardiovascular events are very uncertain (RR 0.15, 95% CI 0.04 to 0.61; very low-certainty evidence; 80 participants). We downgraded the certainty of evidence for study limitations, imprecision, and indirectness as this trial was conducted in a unique group of high-risk participants with pre-existing cardiovascular morbidities.\nDegarelix likely results in an increase in injection site pain (RR 15.68, 95% CI 7.41 to 33.17; moderate-certainty evidence; 2670 participants). Based on 30 participants per 1000 with injection site pain with standard androgen suppression therapy, this corresponds to 440 more injection site pains per 1000 participants (192 more to 965 more). We downgraded the certainty of evidence for study limitations.\nWe did not identify any relevant subgroup differences for different degarelix maintenance doses.\nAuthors' conclusions\nWe did not find trial evidence for overall survival or cancer-specific survival comparing degarelix to standard androgen suppression, but serious adverse events and quality of life may be similar between groups. The effects of degarelix on cardiovascular events are very uncertain as the only eligible study had limitations, was small with few events, and was conducted in a high-risk population. Degarelix likely results in an increase in injection site pain compared to standard androgen suppression therapy. Maximum follow-up of included studies was 14 months, which is short. There is a need for methodologically better designed and executed studies with long-term follow-up evaluating men with metastatic prostate cancer.\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 11 studies that were eligible for inclusion in the review, but none of these studies evaluated the risk of dying from any cause or dying from prostate cancer. There may be no difference between degarelix and standard hormonal therapy in serious unwanted effects and quality of life. The effects of degarelix on cardiovascular issues such as the risk of a heart attack or stroke are uncertain; while one study suggested that the risk may be reduced with degarelix, it had major issues, in particular that it was conducted in men at high risk for such problems. We found that degarelix therapy likely results in an increase in the occurrence of pain at the injection site."
}
]
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query-laysum | 3053 | [
{
"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 did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature for studies that evaluated the effects of beds, mattresses and mattress toppers with a reactive surface that was not air-filled or made of foam. We compared and summarised the results of these studies, and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
]
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query-laysum | 3054 | [
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is defined as the presence of endometrial tissue outside the uterine cavity. This chronic and recurring condition occurs in women of reproductive age. It is a common cause of pain or infertility and can cause non-specific symptoms such as lower back pain, dyspareunia (pain during or after intercourse), and dysmenorrhoea (menstrual pain). Endometriosis is an oestrogen-dependent disease. Medical treatment aims to relieve symptoms and shrink lesions by suppressing the normal menstrual cycle. In this review, we consider medication specifically aiming to modulate oestrogen receptors as an alternative method of treatment.\nObjectives\nTo evaluate the effectiveness and safety of selective oestrogen receptor modulators (SERMs) in the management of endometriosis.\nSearch methods\nWe searched for trials in the following databases (from their inception to 28 May 2020): Cochrane Gynaecology and Fertility Group Specialised Register, Cochrane Central Register of Studies (CRS Online), MEDLINE, Embase, CINAHL, PsycINFO, and registers of ongoing trials. In addition, we searched all reference lists of included trials, and we contacted experts in the field, in an attempt to locate trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing selective oestrogen receptor modulators (SERMs) with placebo, no treatment, other medical treatment, or surgery for endometriosis.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Two review authors independently selected trials for inclusion, assessed risk of bias, and extracted data using data extraction forms. We used risk ratios (RRs) with 95% confidence intervals (CIs) for reporting dichotomous data. Primary review outcomes were relief of pelvic pain and adverse events. Secondary outcomes included quality of life, recurrence rate, and economic and fertility outcomes.\nMain results\nWe included only one RCT, which included 93 women, comparing the SERM raloxifene with placebo in biopsy-proven endometriosis. All women first underwent complete surgical excision of all lesions. Evidence was of very low quality: the main limitation was imprecision - with very sparse data from only one small study, which included only women after surgical treatment.\nRelief of pelvic pain\nThe included study did not specifically measure the primary outcome of pain relief. Study authors reported that time to return of pelvic pain (defined as two months of pain equal to or more severe than pain at study entry) was more rapid in the raloxifene group (P = 0.03).\nAdverse events\nThe included study reported adverse events such as pelvic pain, ovarian cyst, headache, migraine, and depression. We are uncertain whether raloxifene improves the incidence of pelvic pain (RR 1.25, 95% CI 0.63 to 2.45), ovarian cysts (RR 1.57, 95% CI 0.55 to 4.43), headache (RR 1.09, 95% CI 0.49 to 2.43), migraine (RR 0.73, 95% CI 0.28 to 1.95), depression (RR 1.96, 95% CI 0.63 to 6.06), or other adverse events (RR 0.08, 95% CI 0.00 to 1.30) (all: 1 study, n = 93; very low-quality evidence).\nQuality of life\nThe study described a statistically significant difference in mental health quality of life (QoL) by 12 months, in favour of placebo treatment (mean difference 11.1, 95% CI 0.01 to 21.19). Other QoL data did not differ between groups but were not reported in detail.\nRecurrence rate, fertility, and economic outcomes\nWe are uncertain whether raloxifene improves the recurrence rate of endometriosis, proven by biopsy, when compared to placebo (RR 1.20, 95% CI 0.66 to 2.21; 1 study, n = 93; very low-quality evidence). This suggests that if 28% of women taking placebo have biopsy-proven recurrence of endometriosis, between 19% and 62% of those taking raloxifene will do so. These outcomes are prone to bias, as not all women had an actual second laparoscopy. Recurrence based on symptoms (non-menstrual pain, dysmenorrhoea, or dyspareunia) was described; in these cases, symptoms improved after use of raloxifene as well as after use of placebo.\nThe included study did not report data on economic outcomes. No comparative data were available on pregnancy, as the study included only women who agreed to postpone pregnancy until after the study endpoint; the few pregnancies that did occur were uneventful but were regarded as an adverse event.\nAuthors' conclusions\nBased on a single, small RCT and incomplete data, we are uncertain of the effects of SERMs on pain relief in surgically treated patients with endometriosis. The included study was stopped prematurely because of higher pain scores among women who took SERMs when compared to scores among those receiving placebo. Further research is needed to fully evaluate the role of SERMs in endometriosis.\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": "Evidence was of very low quality. The main limitations were inclusion of only one study with a small number of participants and lack of both primary and secondary outcome data."
}
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query-laysum | 3055 | [
{
"role": "user",
"content": "Abstract: Background\nThe partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.\nThis review is an update of a review last published in 2013.\nObjectives\nThe primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs.\nData collection and analysis\nThree review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach.\nMain results\nWe have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.\nMost trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).\nPartograph versus no partograph (3 trials, 1813 women)\nIt is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).\nPartograph with different placement of action lines (4 trials, 5051 women)\nWhen compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.\nThe following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.\nPartograph with alert line only versus partograph with alert and action line (1 trial, 694 women)\nThe caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.\nPartograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)\nThe caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.\nPartograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)\nFewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.\nPartograph versus labour scale (1 trial, 122 women)\nThe use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes.\nAuthors' conclusions\nOn the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.\n\nGiven the provided abstract, please respond to the following query: \"Partograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When we compared a partograph with a two-hour action line and a stepped dystocia line, fewer women received oxytocin augmentation in the dystocia line group. We did not observe any clear differences in any of the other primary outcomes in this comparison."
}
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query-laysum | 3056 | [
{
"role": "user",
"content": "Abstract: Background\nTypical and atypical antipsychotics are widely used to treat agitation and psychosis in dementia. However, whether or not they are beneficial is uncertain. Some trials have yielded negative results and effectiveness may be outweighed by harms.\nObjectives\nTo assess the efficacy and safety of antipsychotics for the treatment of agitation and psychosis in people with Alzheimer's disease and vascular dementia.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid Sp), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register, and the International Clinical Trials Registry Portal on 7 January 2021. Two review authors independently screened the title and abstract of the hits, and two review authors assessed the full text of studies that got through this screening.\nSelection criteria\nWe included randomised, placebo-controlled, parallel-arm trials comparing the effects of antipsychotics and placebo for the treatment of agitation or psychosis in people with dementia due to Alzheimer's disease or vascular dementia, or both, irrespective of age, severity of cognitive impairment, and setting. (The majority of) participants had to have clinically significant agitation (including aggression) or psychosis or both at baseline. We excluded studies about antipsychotics that are no longer available in the USA or EU, or that are used for emergency short-term sedation. We also excluded head-to-head trials and antipsychotic withdrawal trials.\nData collection and analysis\nThe primary outcomes were (1) reduction in agitation or psychosis in participants with agitation or psychosis, respectively at baseline, and (2) the number of participants with adverse events: somnolence, extrapyramidal symptoms, any adverse event, any serious adverse event (SAE), and death.\nTwo review authors independently extracted the necessary data and assessed risk of bias with the Cochrane risk of bias tool. We calculated the pooled effect on agitation and psychosis for typical and atypical antipsychotics separately, and the pooled risk of adverse effects independent of the target symptom (agitation or psychosis). We used RevMan Web for the analyses.\nMain results\nThe search yielded 8233 separate hits. After assessing the full-text of 35 studies, we included 24 trials that met the eligibility criteria. Six trials tested a typical antipsychotic, four for agitation and two for psychosis. Twenty trials tested an atypical antipsychotic, eight for agitation and 12 for psychosis. Two trials tested both drug types. Seventeen of 26 comparisons were performed in patients with Alzheimer’s disease specifically. The other nine comparisons also included patients with vascular dementia or mixed dementia. Together, the studies included 6090 participants (12 to 652 per study). The trials were performed in institutionalised, hospitalised and community-dwelling patients, or a combination of those.\nFor typical antipsychotics (e.g. haloperidol, thiothixene), we are uncertain whether these drugs improve agitation compared with placebo (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -0.57 to -0.15, 4 studies, n = 361); very low-certainty evidence, but typical antipsychotics may improve psychosis slightly (SMD -0.29, 95% CI -0.55 to -0.03, 2studies, n= 240; low-certainty evidence) compared with placebo. These drugs probably increase the risk of somnolence (risk ratio (RR) 2.62, 95% CI 1.51 to 4.56, 3 studies, n = 466; moderate-certainty evidence) and increase extrapyramidal symptoms (RR 2.26, 95% CI 1.58 to 3.23, 3 studies, n = 467; high-certainty) evidence. There was no evidence regarding the risk of any adverse event. The risks of SAEs (RR 1.32, 95% CI 0.65 to 2.66, 1 study, n = 193) and death (RR 1.46, 95% CI 0.54 to 4.00, 6 studies, n = 578) may be increased slightly, but these estimates were very imprecise, and the certainty was low. The effect estimates for haloperidol from five trials were in line with those of the drug class.\nAtypical antipsychotics (e.g. risperidone, olanzapine, aripiprazole, quetiapine) probably reduce agitation slightly (SMD -0.21, 95% CI -0.30 to -0.12, 7 studies, n = 1971; moderate-certainty evidence), but probably have a negligible effect on psychosis (SMD -0.11, 95% CI -0.18 to -0.03, 12 studies, n = 3364; moderate-certainty evidence). These drugs increase the risk of somnolence (RR 1.93, 95% CI 1.57 to 2.39, 13 studies, n - 3878; high-certainty evidence) and are probably also associated with slightly increased risk of extrapyramidal symptoms (RR 1.39, 95% CI 1.14 to 1.68, 15 studies, n = 4180; moderate-certainty evidence), serious adverse events (RR 1.32, 95% CI 1.09 to 1.61, 15 studies, n= 4316; moderate-certainty evidence) and death (RR 1.36, 95% CI 0.90 to 2.05, 17 studies, n= 5032; moderate-certainty evidence), although the latter estimate was imprecise. The drugs probably have a negligible effect on the risk of any adverse event (RR 1.05, 95% CI 1.02 to 1.09, 11 studies, n = 2785; moderate-certainty evidence). The findings from seven trials for risperidone were in line with those for the drug class.\nAuthors' conclusions\nThere is some evidence that typical antipsychotics might decrease agitation and psychosis slightly in patients with dementia. Atypical antipsychotics reduce agitation in dementia slightly, but their effect on psychosis in dementia is negligible. The apparent effectiveness of the drugs seen in daily practice may be explained by a favourable natural course of the symptoms, as observed in the placebo groups. Both drug classes increase the risk of somnolence and other adverse events. If antipsychotics are considered for sedation in patients with severe and dangerous symptoms, this should be discussed openly with the patient and legal representative.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Typical antipsychotics (haloperidol, thiothixene) compared with placebo:\n- may improve symptoms of psychosis slightly (2 studies, 240 people), but we are uncertain about their effect on agitation (4 studies, 361 people);\n- probably increase the risk of drowsiness (3 studies, 466 people), and movement disorders (3 studies, 467 people);\n- may slightly increase the risk of serious unwanted effects (1 study, 193 people) and of death (6 studies, 578 people).\nThere was no evidence about the risk of non-serious and serious unwanted effects combined.\nAtypical antipsychotics (risperidone, olanzapine, aripiprazole, quetiapine) compared with placebo:\n- probably slightly reduce agitation (7 studies, 1971 people) and may slightly reduce aggression (1 study, 301 people), but probably make no important difference to symptoms of psychosis (12 studies, 3364 people);\n- increase the risk of drowsiness (13 studies, 2878 people) and probably slightly increase movement disorders (15 studies, 4180 people);\n- probably slightly increase the risk of experiencing any non-serious or serious unwanted effect combined, the risk of serious unwanted effects, and the risk of death (17 studies, 5032 people)."
}
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query-laysum | 3057 | [
{
"role": "user",
"content": "Abstract: Background\nIdiopathic toe walking (ITW) is an exclusionary diagnosis given to healthy children who persist in walking on their toes after they should typically have achieved a heel-toe gait. The literature discusses conservative and surgical interventions using a variety of treatment modalities. Young children and children without a limitation in ankle dorsiflexion (the upwards movement of the foot towards the shin of the leg) are commonly treated with conservative interventions. Older children who continue toe walking and present with limitations in ankle dorsiflexion are sometimes treated with surgical procedures. This systematic review is needed to evaluate the evidence for any intervention for the treatment of ITW. The conclusions of this review may support decision making by clinicians caring for children with ITW. It may also assist families when deciding on treatment options for their children with ITW. Many of the treatments employed have financial implications for parents or healthcare services. This review also aims to highlight any deficits in the current research base.\nObjectives\nTo assess the effects of conservative and surgical interventions in children with ITW, specifically effects on gait normalisation, ankle range of motion, pain, frequency of recurrence, and any adverse effects.\nSearch methods\nOn 29 April 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL Plus, and PEDro. We searched the following registers of clinical trials for ongoing and recently completed trials: the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP, apps.who.int/trialsearch), and ClinicalTrials.gov (clinicaltrials.gov). We searched conference proceedings and other grey literature in the BIOSIS databases and System for Information on Grey Literature in Europe (OpenGrey, opengrey.eu). We searched guidelines via the Turning Research Into Practice database (TRIP, tripdatabase.com) and National Guideline Clearinghouse (guideline.gov). We did not apply language restrictions.\nSelection criteria\nWe considered randomised or quasi-randomised trials for inclusion in the review if they involved participants diagnosed with ITW gait in the absence of a medical condition known to cause toe walking, or associated with toe walking. As there is no universally accepted age group for ITW, this review includes ITW at any age, who have been toe walking for more than six months, who can or cannot walk with a heel-toe gait, and who may or may not have limited dorsiflexion of the ankle joint.\nData collection and analysis\nWe used standard Cochrane methodological procedures. The primary outcome was improvement in toe walking (defined as greater than 50% of time spent heel-toe walking). Secondary outcomes were active and passive range of motion of the ankle joint, pain, recurrence of ITW after treatment, and adverse events. We assessed the certainty of the evidence using the GRADE framework.\nMain results\nFour studies, comprising 104 participants, met the inclusion criteria. One study did not report data within the appropriate follow-up timeframe and data from two studies were insufficient for analysis. The single study from which we extracted data had 47 participants and was a randomised, controlled, parallel-group trial conducted in Sweden. It tested the hypothesis that combined treatment with serial casting and botulinum toxin type A (BTX) was more effective than serial casting alone in reducing ITW gait.\nThis study found that more participants treated with BTX improved (defined as toe walking less than 50% of the time, as reported by parents) (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.57 to 2.55; 1 trial, 46 participants; very low-certainty evidence). However, there was little or no difference between groups in passive ankle joint dorsiflexion range of movement on the right with the knee extended (mean difference (MD) -1.48º, 95% CI -4.13 to 1.16; 1 trial, 47 participants), on the right with the knee flexed (MD -0.04º, 95% CI -1.80 to 1.73; 1 trial, 46 participants), on the left with the knee flexed (MD 1.07, 95% CI -1.22 to 3.37), or on the left with the knee extended (MD 0.05, 95% CI -0.91 to 1.91). Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants). In principle, MDs greater than zero (i.e.) positive values) would favour BTX and casting and negative values would favour casting alone. We have not reported effects as better or worse because all results were from evidence of very low certainty. We downgraded the certainty of evidence because of study limitations (outcome assessment was not blinded) and imprecision. Outcomes of pain and active range of motion were not reported in the included study.\nIn terms of adverse events, calf pain was reported twice in the casting-only group and three times in the BTX group. There were three minor skin problems in each group and one reported case of pain directly after BTX injection. The report did not state if calf pain and skin irritation were from the same or different participants. The study authors reported that adverse events did not alter treatment adherence.\nAuthors' conclusions\nThe certainty of evidence from one study, which compared serial casting with serial casting with BTX for ITW in children, was too low for conclusions to be drawn. A further three studies reported outcomes relating to BTX, footwear, exercises, and different types of orthoses as interventions, however the outcome data were too limited to assess their effects.\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": "Four trials met the inclusion criteria. They included a total of 104 people; however, three trials did not provide results that we could include in the review. (One trial studied different kinds of foot orthoses, which are in-shoe devices that redistribute force and change gait), and two investigated the effects of adding botulinum toxin injections to various treatments such as stretching, exercises, splints, and footwear.) This review therefore only included the results of one trial, in which 47 children (aged between 5 and 14.5 years) received treatment with either plaster casts alone or plaster casts and injections of botulinum toxin A (BTX) into calf muscles. The study reported how much the children toe walked (based on their parents' observation), any change in ankle range of movement, and relapse (whether the children were still toe walking 12 months after treatment). The included study took place in Sweden and was not funded by anyone with a commercial interest in the results of the study."
}
]
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query-laysum | 3058 | [
{
"role": "user",
"content": "Abstract: Background\nEarly warning systems (EWS) and rapid response systems (RRS) have been implemented internationally in acute hospitals to facilitate early recognition, referral and response to patient deterioration as a solution to address suboptimal ward-based care. EWS and RRS facilitate healthcare decision-making using checklists and provide structure to organisational practices through governance and clinical audit. However, it is unclear whether these systems improve patient outcomes. This is the first update of a previously published (2007) Cochrane Review.\nObjectives\nTo determine the effect of EWS and RRS implementation on adults who deteriorate on acute hospital wards compared to people receiving hospital care without EWS and RRS in place.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two trial registers on 28 March 2019. We subsequently ran a MEDLINE update on 15 May 2020 that identified no further studies. We checked references of included studies, conducted citation searching, and contacted experts and critical care organisations.\nSelection criteria\nWe included randomised trials, non-randomised studies, controlled before-after (CBA) studies, and interrupted time series (ITS) designs measuring our outcomes of interest following implementation of EWS and RRS in acute hospital wards compared to ward settings without EWS and RRS.\nData collection and analysis\nTwo review authors independently checked studies for inclusion, extracted data and assessed methodological quality using standard Cochrane and Effective Practice and Organisation of Care (EPOC) Group methods. Where possible, we standardised data to rates per 1000 admissions; and calculated risk differences and 95% confidence intervals (CI) using the Newcombe and Altman method. We reanalysed three CBA studies as ITS designs using segmented regression analysis with Newey-West autocorrelation adjusted standard errors with lag of order 1. We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe included four randomised trials (455,226 participants) and seven non-randomised studies (210,905 participants reported in three studies). All 11 studies implemented an intervention comprising an EWS and RRS conducted in high- or middle-income countries. Participants were admitted to 282 acute hospitals. We were unable to perform meta-analyses due to clinical and methodological heterogeneity across studies. Randomised trials were assessed as high risk of bias due to lack of blinding participants and personnel across all studies. Risk of bias for non-randomised studies was critical (three studies) due to high risk of confounding and unclear risk of bias due to no reporting of deviation from protocol or serious (four studies) but not critical due to use of statistical methods to control for some but not all baseline confounders. Where possible we presented original study data which reported the adjusted relative effect given these were appropriately adjusted for design and participant characteristics. We compared outcomes of randomised and non-randomised studies reported them separately to determine which studies contributed to the overall certainty of evidence. We reported findings from key comparisons.\nHospital mortality\nRandomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in hospital mortality (4 studies, 455,226 participants; results not pooled). The evidence on hospital mortality from three non-randomised studies was of very low certainty (210,905 participants).\nComposite outcome (unexpected cardiac arrests, unplanned ICU admissions and death)\nOne randomised study showed that an EWS and RRS intervention probably results in no difference in this composite outcome (adjusted odds ratio (aOR) 0.98, 95% CI 0.83 to 1.16; 364,094 participants; moderate-certainty evidence). One non-randomised study suggests that implementation of an EWS and RRS intervention may slightly reduce this composite outcome (aOR 0.85, 95% CI 0.72 to 0.99; 57,858 participants; low-certainty evidence).\nUnplanned ICU admissions\nRandomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in unplanned ICU admissions (3 studies, 452,434 participants; results not pooled). The evidence from one non-randomised study is of very low certainty (aOR 0.88, 95% CI 0.75 to 1.02; 57,858 participants).\nICU readmissions\nNo studies reported this outcome.\nLength of hospital stay\nRandomised trials provided low-certainty evidence that an EWS and RRS intervention may have little or no effect on hospital length of stay (2 studies, 21,417 participants; results not pooled).\nAdverse events (unexpected cardiac or respiratory arrest)\nRandomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in adverse events (3 studies, 452,434 participants; results not pooled). The evidence on adverse events from three non-randomised studies (210,905 participants) is very uncertain.\nAuthors' conclusions\nGiven the low-to-very low certainty evidence for all outcomes from non-randomised studies, we have drawn our conclusions from the randomised evidence. This evidence provides low-certainty evidence that EWS and RRS may lead to little or no difference in hospital mortality, unplanned ICU admissions, length of hospital stay or adverse events; and moderate-certainty evidence of little to no difference on composite outcome. The evidence from this review update highlights the diversity in outcome selection and poor methodological quality of most studies investigating EWS and RRS. As a result, no strong recommendations can be made regarding the effectiveness of EWS and RRS based on the evidence currently available. There is a need for development of a patient-informed core outcome set comprising clear and consistent definitions and recommendations for measurement as well as EWS and RRS interventions conforming to a standard to facilitate meaningful comparison and future meta-analyses.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found evidence that checklists to help doctors and nurses recognise and refer patients who get worse early to specialist teams for management may result in little or no difference to the number of deaths, unplanned ICU admissions, length of hospital stay or cardiac arrests in hospital."
}
]
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query-laysum | 3059 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical training has traditionally been one of apprenticeship, where the surgical trainee learns to perform surgery under the supervision of a trained surgeon. This is time consuming, costly, and of variable effectiveness. Training using a box model physical simulator - either a video box or a mirrored box - is an option to supplement standard training. However, the impact of this modality on trainees with no prior laparoscopic experience is unknown.\nObjectives\nTo compare the benefits and harms of box model training versus no training, another box model, animal model, or cadaveric model training for surgical trainees with no prior laparoscopic experience.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to May 2013.\nSelection criteria\nWe included all randomised clinical trials comparing box model trainers versus no training in surgical trainees with no prior laparoscopic experience. We also included trials comparing different methods of box model training.\nData collection and analysis\nTwo authors independently identified trials and collected data. We analysed the data with both the fixed-effect and the random-effects models using Review Manager for analysis. For each outcome, we calculated the standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat analysis whenever possible.\nMain results\nTwenty-five trials contributed data to the quantitative synthesis in this review. All but one trial were at high risk of bias. Overall, 16 trials (464 participants) provided data for meta-analysis of box training (248 participants) versus no supplementary training (216 participants). All the 16 trials in this comparison used video trainers. Overall, 14 trials (382 participants) provided data for quantitative comparison of different methods of box training. There were no trials comparing box model training versus animal model or cadaveric model training.\nBox model training versus no training: The meta-analysis showed that the time taken for task completion was significantly shorter in the box trainer group than the control group (8 trials; 249 participants; SMD -0.48 seconds; 95% CI -0.74 to -0.22). Compared with the control group, the box trainer group also had lower error score (3 trials; 69 participants; SMD -0.69; 95% CI -1.21 to -0.17), better accuracy score (3 trials; 73 participants; SMD 0.67; 95% CI 0.18 to 1.17), and better composite performance scores (SMD 0.65; 95% CI 0.42 to 0.88). Three trials reported movement distance but could not be meta-analysed as they were not in a format for meta-analysis. There was significantly lower movement distance in the box model training compared with no training in one trial, and there were no significant differences in the movement distance between the two groups in the other two trials. None of the remaining secondary outcomes such as mortality and morbidity were reported in the trials when animal models were used for assessment of training, error in movements, and trainee satisfaction.\nDifferent methods of box training: One trial (36 participants) found significantly shorter time taken to complete the task when box training was performed using a simple cardboard box trainer compared with the standard pelvic trainer (SMD -3.79 seconds; 95% CI -4.92 to -2.65). There was no significant difference in the time taken to complete the task in the remaining three comparisons (reverse alignment versus forward alignment box training; box trainer suturing versus box trainer drills; and single incision versus multiport box model training). There were no significant differences in the error score between the two groups in any of the comparisons (box trainer suturing versus box trainer drills; single incision versus multiport box model training; Z-maze box training versus U-maze box training). The only trial that reported accuracy score found significantly higher accuracy score with Z-maze box training than U-maze box training (1 trial; 16 participants; SMD 1.55; 95% CI 0.39 to 2.71). One trial (36 participants) found significantly higher composite score with simple cardboard box trainer compared with conventional pelvic trainer (SMD 0.87; 95% CI 0.19 to 1.56). Another trial (22 participants) found significantly higher composite score with reverse alignment compared with forward alignment box training (SMD 1.82; 95% CI 0.79 to 2.84). There were no significant differences in the composite score between the intervention and control groups in any of the remaining comparisons. None of the secondary outcomes were adequately reported in the trials.\nAuthors' conclusions\nThe results of this review are threatened by both risks of systematic errors (bias) and risks of random errors (play of chance). Laparoscopic box model training appears to improve technical skills compared with no training in trainees with no previous laparoscopic experience. The impacts of this decreased time on patients and healthcare funders in terms of improved outcomes or decreased costs are unknown. There appears to be no significant differences in the improvement of technical skills between different methods of box model training. Further well-designed trials of low risk of bias and random errors are necessary. Such trials should assess the impacts of box model training on surgical skills in both the short and long term, as well as clinical outcomes when the trainee becomes competent to operate on patients.\n\nGiven the provided abstract, please respond to the following query: \"Future research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Further well-designed trials with less risk of bias because of poor study design or because of chance are necessary."
}
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query-laysum | 3060 | [
{
"role": "user",
"content": "Abstract: Background\nStudies evaluating mass drug administration (MDA) in malarious areas have shown reductions in malaria immediately following the intervention. However, these effects vary by endemicity and are not sustained. Since the 2013 version of this Cochrane Review on this topic, additional studies have been published.\nObjectives\nPrimary objectives\nTo assess the sustained effect of MDA with antimalarial drugs on:\n- the reduction in malaria transmission in moderate- to high-transmission settings;\n- the interruption of transmission in very low- to low-transmission settings.\nSecondary objective\nTo summarize the risk of drug-associated adverse effects following MDA.\nSearch methods\nWe searched several trial registries, citation databases, conference proceedings, and reference lists for relevant articles up to 11 February 2021. We also communicated with researchers to identify additional published and unpublished studies.\nSelection criteria\nRandomized controlled trials (RCTs) and non-randomized studies comparing MDA to no MDA with balanced co-interventions across study arms and at least two geographically distinct sites per study arm.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and extracted data. We calculated relative risk (RR) and rate ratios with corresponding 95% confidence intervals (CIs) to compare prevalence and incidence, respectively, in MDA compared to no-MDA groups. We stratified analyses by malaria transmission and by malaria species. For cluster-randomized controlled trials (cRCTs), we adjusted standard errors using the intracluster correlation coefficient. We assessed the certainty of the evidence using the GRADE approach. For non-randomized controlled before-and-after (CBA) studies, we summarized the data using difference-in-differences (DiD) analyses.\nMain results\nThirteen studies met our criteria for inclusion. Ten were cRCTs and three were CBAs.\nCluster-randomized controlled trials\nModerate- to high-endemicity areas (prevalence ≥ 10%)\nWe included data from two studies conducted in The Gambia and Zambia.\nAt one to three months after MDA, the Plasmodium falciparum (hereafter, P falciparum) parasitaemia prevalence estimates may be higher compared to control but the CIs included no effect (RR 1.76, 95% CI 0.58 to 5.36; Zambia study; low-certainty evidence); parasitaemia incidence was probably lower (RR 0.61, 95% CI 0.40 to 0.92; The Gambia study; moderate-certainty evidence); and confirmed malaria illness incidence may be substantially lower, but the CIs included no effect (rate ratio 0.41, 95% CI 0.04 to 4.42; Zambia study; low-certainty evidence).\nAt four to six months after MDA, MDA showed little or no effect on P falciparum parasitaemia prevalence (RR 1.18, 95% CI 0.89 to 1.56; The Gambia study; moderate-certainty evidence) and, no persisting effect was demonstrated with parasitaemia incidence (rate ratio 0.91, 95% CI 0.55 to 1.50; The Gambia study).\nVery low- to low-endemicityareas (prevalence < 10%)\nSeven studies from Cambodia, Laos, Myanmar (two studies), Vietnam, Zambia, and Zanzibar evaluated the effects of multiple rounds of MDA on P falciparum. Immediately following MDA (less than one month after MDA), parasitaemia prevalence was reduced (RR 0.12, 95% CI 0.03 to 0.52; one study; low-certainty evidence). At one to three months after MDA, there was a reduction in both parasitaemia incidence (rate ratio 0.37, 95% CI 0.21 to 0.55; 1 study; moderate-certainty evidence) and prevalence (RR 0.25, 95% CI 0.15 to 0.41; 7 studies; low-certainty evidence). For confirmed malaria incidence, absolute rates were low, and it is uncertain whether MDA had an effect on this outcome (rate ratio 0.58, 95% CI 0.12 to 2.73; 2 studies; very low-certainty evidence).\nFor P falciparum prevalence, the relative differences declined over time, from RR 0.63 (95% CI 0.36 to 1.12; 4 studies) at four to six months after MDA, to RR 0.86 (95% CI 0.55 to 1.36; 5 studies) at 7 to 12 months after MDA. Longer-term prevalence estimates showed overall low absolute risks, and relative effect estimates of the effect of MDA on prevalence varied from RR 0.82 (95% CI 0.20 to 3.34) at 13 to 18 months after MDA, to RR 1.25 (95% CI 0.25 to 6.31) at 31 to 36 months after MDA in one study.\nFive studies from Cambodia, Laos, Myanmar (2 studies), and Vietnam evaluated the effect of MDA on Plasmodium vivax (hereafter, P vivax). One month following MDA, P vivax prevalence was lower (RR 0.18, 95% CI 0.08 to 0.40; 1 study; low-certainty evidence). At one to three months after MDA, there was a reduction in P vivax prevalence (RR 0.15, 95% CI 0.10 to 0.24; 5 studies; low-certainty evidence). The immediate reduction on P vivax prevalence was not sustained over time, from RR 0.78 (95% CI 0.63 to 0.95; 4 studies) at four to six months after MDA, to RR 1.12 (95% CI 0.94 to 1.32; 5 studies) at 7 to 12 months after MDA. One of the studies in Myanmar provided estimates of longer-term effects, where overall absolute risks were low, ranging from RR 0.81 (95% CI 0.44 to 1.48) at 13 to 18 months after MDA, to RR 1.20 (95% CI 0.44 to 3.29) at 31 to 36 months after MDA.\nNon-randomized studies\nThree CBA studies were conducted in moderate- to high-transmission areas in Burkina Faso, Kenya, and Nigeria. There was a reduction in P falciparum parasitaemia prevalence in MDA groups compared to control groups during MDA (DiD range: -15.8 to -61.4 percentage points), but the effect varied at one to three months after MDA (DiD range: 14.9 to -41.1 percentage points).\nAuthors' conclusions\nIn moderate- to high-transmission settings, no studies reported important effects on P falciparum parasitaemia prevalence within six months after MDA. In very low- to low-transmission settings, parasitaemia prevalence and incidence were reduced initially for up to three months for both P falciparum and P vivax; longer-term data did not demonstrate an effect after four months, but absolute risks in both intervention and control groups were low. No studies provided evidence of interruption of malaria transmission.\n\nGiven the provided abstract, please respond to the following query: \"How can MDA reduce malaria transmission in a population?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The life cycle of the malaria parasite consists of human liver, human blood, and mosquito stages. Malaria infection begins with the bite of an Anopheles species mosquito carrying the malaria parasite. During the bite, the infective mosquito injects the malaria parasite into the human host. After initially replicating in the liver, the parasites are released into the bloodstream. During the blood stage, parasites multiply in red blood cells, sometimes causing fever and other symptoms characteristic of malaria. Some of these parasites become a form which is infectious to mosquitoes. When the infected person is bitten again, the mosquito ingests blood containing the parasites, which then restarts the transmission cycle.\nMDA with antimalarial drugs temporarily prevents new and clears existing malaria infections in the population. Depending on the characteristics of the antimalarial drug used, MDA targets parasites at different stages, which can lead to reduced disease burden and transmission in the population. Whether MDA can successfully reduce or interrupt malaria transmission may depend on how much malaria there is in the area; the use of other tools to control malaria, including preventing mosquito bites; the proportion of the population who receive at least one round of MDA; population movement; and when MDA rounds occur in relation to the peak malaria transmission season."
}
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query-laysum | 3061 | [
{
"role": "user",
"content": "Abstract: Background\nMany smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully.\nObjectives\nThe aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018.\nSelection criteria\nWe included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist.\nData collection and analysis\nWe extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model.\nMain results\nWe identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.\nThirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).\nThirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.\nFive studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes.\nAuthors' conclusions\nModerate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.\nAvailable evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched electronic databases for studies that investigated printed self-help. We ran our most recent search in March 2018, and so far we have found 75 studies. Most studies took place in North America or Europe and were carried out with adults, although they did not require that people wanted to quit smoking to join. Studies delivered self-help materials in person or by post, some all at once, and some spread out over the length of the study. In most studies, self-help was the only support people were given, but some studies tested self-help given with other kinds of support to test whether there was any extra benefit from written self-help. Some studies gathered information about individual smokers, so they could tailor self-help to better help them."
}
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query-laysum | 3062 | [
{
"role": "user",
"content": "Abstract: Background\nPityriasis rosea is a scaly, itchy rash that mainly affects young adults and lasts for 2 to 12 weeks. The effects of many available treatments are uncertain. This is an update of a Cochrane Review first published in 2007.\nObjectives\nTo assess the effects of interventions for the management of pityriasis rosea in any individual diagnosed by a medical practitioner.\nSearch methods\nWe updated our searches of the following databases to October 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched five trials registers. We also checked the reference lists of included and excluded studies, contacted trial authors, scanned the abstracts from major dermatology conference proceedings, and searched the CAB Abstracts database. We searched PubMed for adverse effects to November 2018.\nSelection criteria\nRandomised controlled trials of interventions in pityriasis rosea. Treatment could be given in a single therapy or in combination. Eligible comparators were no treatment, placebo, vehicle only, another active compound, or placebo radiation treatment.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane. Our key outcomes were good or excellent rash improvement within two weeks, rated separately by the participant and medical practitioner; serious adverse events; resolution of itch within two weeks (participant-rated); reduction in itch score within two weeks (participant-rated); and minor participant-reported adverse events not requiring withdrawal of the treatment.\nMain results\nWe included 14 trials (761 participants). In general, risk of selection bias was unclear or low, but risk of performance bias and reporting bias was high for 21% of the studies.\nParticipant age ranged from 2 to 60 years, and sex ratio was similar. Disease severity was measured by various severity indices, which the included studies did not categorise. Six studies were conducted in India, three in Iran, two in the Philippines, and one each in Pakistan, the USA, and China. The included studies were conducted in dermatology departments and a paediatric clinic. Study duration ranged from 5 to 26 months. Three studies were funded by drug manufacturers; most studies did not report their funding source. The included studies assessed macrolide antibiotics, an antiviral agent, phototherapy, steroids and antihistamine, and Chinese medicine.\nNone of the studies measured participant-rated good or excellent rash improvement. All reported outcomes were assessed within two weeks of treatment, except for adverse effects, which were measured throughout treatment.\nThere is probably no difference between oral clarithromycin and placebo in itch resolution (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.47 to 1.52; 1 study, 28 participants) or rash improvement (medical practitioner-rated) (RR 1.13, 95% CI 0.89 to 1.44; 1 study, 60 participants). For this comparison, there were no serious adverse events (1 study, 60 participants); minor adverse events and reduction in itch score were not measured; and all evidence was of moderate quality.\nWhen compared with placebo, erythromycin may lead to increased rash improvement (medical practitioner-rated) (RR 4.02, 95% CI 0.28 to 56.61; 2 studies, 86 participants, low-quality evidence); however, the 95% CI indicates that the result may also be compatible with a benefit of placebo, and there may be little or no difference between treatments. Itch resolution was not measured, but one study measured reduction in itch score, which is probably larger with erythromycin (MD 3.95, 95% CI 3.37 to 4.53; 34 participants, moderate-quality evidence). In the same single, small trial, none of the participants had a serious adverse event, and there was no clear difference between groups in minor adverse events, which included gastrointestinal upset (RR 2.00, CI 0.20 to 20.04; moderate-quality evidence).\nTwo trials compared oral azithromycin to placebo or vitamins. There is probably no difference between groups in itch resolution (RR 0.83, 95% CI 0.28 to 2.48) or reduction in itch score (MD 0.04, 95% CI −0.35 to 0.43) (both outcomes based on one study; 70 participants, moderate-quality evidence). Low-quality evidence from two studies indicates there may be no difference between groups in rash improvement (medical practitioner-rated) (RR 1.02, 95% CI 0.52 to 2.00; 119 participants). In these same two studies, no serious adverse events were reported, and there was no clear difference between groups in minor adverse events, specifically mild abdominal pain (RR 5.82, 95% CI 0.72 to 47.10; moderate-quality evidence).\nAcyclovir was compared to placebo, vitamins, or no treatment in three trials (all moderate-quality evidence). Based on one trial (21 participants), itch resolution is probably higher with placebo than with acyclovir (RR 0.34, 95% CI 0.12 to 0.94); reduction in itch score was not measured. However, there is probably a significant difference between groups in rash improvement (medical practitioner-rated) in favour of acyclovir versus all comparators (RR 2.45, 95% CI 1.33 to 4.53; 3 studies, 141 participants). Based on the same three studies, there were no serious adverse events in either group, and there was probably no difference between groups in minor adverse events (only one participant in the placebo group experienced abdominal pain and diarrhoea).\nOne trial compared acyclovir added to standard care (calamine lotion and oral cetirizine) versus standard care alone (24 participants). The addition of acyclovir may lead to increased itch resolution (RR 4.50, 95% CI 1.22 to 16.62) and reduction in itch score (MD 1.26, 95% CI 0.74 to 1.78) compared to standard care alone. Rash improvement (medical practitioner-rated) was not measured. The trial reported no serious adverse events in either group, and there may be no difference between groups in minor adverse events, such as headache (RR 7.00, 95% CI 0.40 to 122.44) (all results based on low-quality evidence).\nAuthors' conclusions\nWhen compared with placebo or no treatment, oral acyclovir probably leads to increased good or excellent, medical practitioner-rated rash improvement. However, evidence for the effect of acyclovir on itch was inconclusive. We found low- to moderate-quality evidence that erythromycin probably reduces itch more than placebo.\nSmall study sizes, heterogeneity, and bias in blinding and selective reporting limited our conclusions. Further research is needed to investigate different dose regimens of acyclovir and the effect of antivirals on pityriasis rosea.\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 for the main comparisons was low to moderate. Many of the results were based on a small number of trials, with a low number of participants. There was also some variation amongst the trial results and concerns over study design."
}
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query-laysum | 3063 | [
{
"role": "user",
"content": "Abstract: Background\nPercutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adults, on intensive care units (ICUs), who require long-term ventilation. PDT is associated with relevant life-threatening complications: Cuff rupture or accidental extubation may lead to hypoxia, aspiration or loss of airway. Puncture of the oesophagus, or creating a false passage during dilatation or replacement of the tracheostomy tube, can lead to pneumothorax or emphysema. Wound infections may occur which can cause mediastinits, especially after creation of false passage or in early tracheotomized post-sternotomy patients after cardiac surgery. During the procedure, the patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA). This is an updated version of the review first published in 2014.\nObjectives\nTo assess the safety and effectiveness of LMA versus ETT in critically ill adults undergoing PDT on the ICU.\nSearch methods\nWe searched the following databases to 9 January 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase. We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of five relevant annual congresses. We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared use of laryngeal mask airways versus endotracheal tubes in critically ill adults undergoing elective PDT in the ICU, without injuries to or diseases of the face or neck. We imposed no restrictions with regard to language, timing or technique of PDT performed.\nData collection and analysis\nTwo review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. Our primary outcomes were all-cause mortality, procedure-related mortality and tally of participants with one or more serious adverse events. Where possible, we combined homogeneous studies for meta-analysis. We used Cochrane's 'Risk of bias' tool and used GRADE to assess the quality of evidence for key outcomes.\nMain results\nWe included nine RCTs in this review involving 517 participants.\nStudies had a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40, and a maximum of 73 participants.\nIn one study (40 participants), three deaths in the LMA group and two deaths in the ETT group were reported, although none of the deaths were related to the procedure (very low-quality evidence).\nFive studies (281 participants) reported on procedure-related deaths, stating that no procedure-related death occurred at all (very low-quality evidence).\nIt is uncertain whether there is a difference in the number of people experiencing one or more serious adverse event(s) between LMA and ETT (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.41 to 1.80; 467 participants, 8 studies, very low-quality evidence).\nThe duration of the procedure may be shorter in the LMA group (mean difference (MD) -1.46 minutes, 95% CI -1.92 to -1.01 minutes; 6 studies, 324 participants, low-quality evidence).\nHowever failure of procedure, as allocated by randomization, requiring conversion to any other procedure, may be higher in the LMA group (RR 2.82, 95% CI 1.22 to 6.52; 8 studies, 439 participants, low-quality evidence).\nWe did not find any clear evidence of a difference between ETT and LMA groups for all other outcomes. Only one study provided follow-up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group.\nAuthors' conclusions\nEvidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on either its efficacy or safety compared with ETT. Although the LMA procedure may shorten the period during which the airway is insecure, it may also lead to higher conversion rates. Also, late complications have not been investigated sufficiently. These results are primarily based on single-centre trials with small sample sizes, and therefore the level of evidence remains low. Studies with low risk of bias focusing on late complications and relevant patient-related outcomes are necessary for definitive conclusions on safety issues related to this procedure. The dependency of the successful placement of a LMA on the type of LMA used should also be further assessed.\nThere are two studies awaiting classification that may alter the conclusions once assessed.\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 compared different ways of securing patients' airways so that the patients can continue to be ventilated during planned opening of the trachea. This procedure is needed for adults hospitalized for a length of time in an intensive care unit (ICU) and continuing to require artificial ventilation. The use of a laryngeal mask airway was compared with the existing endotracheal tube in terms of the safety and effectiveness of the procedure."
}
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query-laysum | 3064 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in 2008 and updated in 2013.\nEpilepsy is a common neurological condition which affects up to 1% of the population. Approximately 30% of people with epilepsy do not respond to treatment with currently available drugs. The majority of these people have focal epilepsy. Vigabatrin is an antiepileptic drug licensed for use in drug-resistant epilepsy.\nObjectives\nTo assess the efficacy and tolerability of vigabatrin as an add-on therapy for people with drug-resistant focal epilepsy.\nSearch methods\nFor the latest update of this review, we searched the following databases on 1 November 2018: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid 1946 to 31 October 2018), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL) are both included in the Cochrane Register of Studies (CRS Web). We checked reference lists of retrieved studies for additional reports of relevant studies and contacted Hoechst Marion Roussel (manufacturers of vigabatrin) in 2000.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled, fully published trials of vigabatrin in people of any age with drug-resistant focal epilepsy.\nData collection and analysis\nTwo review authors assessed trials for inclusion and extracted data using the standard methodological procedures expected by Cochrane. Primary analysis was by intention-to-treat (ITT). We evaluated: 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, dose-response analysis, cognitive outcomes and quality of life. We presented results as risk ratios (RR) with 95% or 99% confidence intervals (CI).\nMain results\nWe identified 11 trials that included 756 participants (age range: 10 to 64 years). The trials tested vigabatrin doses between 1 g/day and 6 g/day. All 11 trials displayed a risk of bias across at least three risk of bias domains. Predominantly, the risk of bias was associated with: allocation concealment (selection bias), blinding of outcome assessment (detection bias) and incomplete outcome data (attrition bias).\nParticipants treated with vigabatrin may be two to three times more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.60, 95% CI 1.87 to 3.63; 4 studies; low-certainty evidence). Those treated with vigabatrin may also be three times more likely to have treatment withdrawn although we are uncertain (RR 2.86, 95% CI 1.25 to 6.55; 4 studies; very low-certainty evidence).\nCompared to placebo, participants given vigabatrin were more likely to experience adverse effects: dizziness/light-headedness (RR 1.74, 95% CI 1.05 to 2.87; 9 studies; low-certainty evidence), fatigue (RR 1.65, 95% CI 1.08 to 2.51; 9 studies; low-certainty evidence), drowsiness (RR 1.70, 95% CI 1.18 to 2.44; 8 studies) and depression (RR 3.28, 95% CI 1.30 to 8.27; 6 studies).\nAlthough the incidence rates were higher among participants receiving vigabatrin compared to those receiving placebo, the effect was not significant for the following adverse effects: ataxia (RR 2.76, 95% CI 0.96 to 7.94; 7 studies; very low-certainty evidence), nausea (RR 3.57, 95% CI 0.63 to 20.30; 4 studies), abnormal vision (RR 1.64, 95% CI 0.67 to 4.02; 5 studies; very low-certainty evidence), headache (RR 1.23, 95% CI 0.79 to 1.92; 9 studies), diplopia (RR 1.76, 99% CI 0.94 to 3.30) and nystagmus (RR 1.53, 99% CI 0.62 to 3.76; 2 studies; low-certainty evidence).\nVigabatrin had little to no effect on cognitive outcomes or quality of life.\nAuthors' conclusions\nVigabatrin may significantly reduce seizure frequency in people with drug-resistant focal epilepsy. The results largely apply to adults and should not be extrapolated to children under 10 years old. Short-term follow-up of participants showed that some adverse effects were associated with its use. Analysis of longer-term observational studies elsewhere, however, has demonstrated that vigabatrin use can lead to the development of visual field defects.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Epilepsy is a common neurological disorder affecting approximately 1 in 100 people. Around 30% of these people cannot control their epilepsy with currently available antiepileptic medication and are said to have drug-resistant epilepsy. Most often, drug-resistant epilepsy is focal in nature, meaning that the seizures start in one specific area of the brain. Vigabatrin is an antiepileptic medication that can be used as an add-on treatment for drug-resistant focal epilepsy, meaning that it is taken in addition to other antiepileptic medications."
}
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query-laysum | 3065 | [
{
"role": "user",
"content": "Abstract: Background\nFracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. This is an update of a Cochrane Review published in 2007.\nObjectives\nTo assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registers, conference proceedings and reference lists of articles up to June 2019.\nSelection criteria\nRandomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months.\nData collection and analysis\nAt least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome.\nMain results\nWe included 21 randomised controlled trials (RCTs) and five quasi-RCTs, involving 1946 generally older and female adults with dorsally displaced and potentially or evidently unstable distal radial fractures. Trial populations varied but the majority of studies reported mean ages in the sixth decade or older. All trials were at high risk of bias, invariably performance bias - which for most trials reflected the impracticality of blinding care providers or participants to treatment allocation - and often detection bias and selective reporting bias. Allocation concealment was secure in one trial only. All trials reported outcomes incompletely. The studies tested one of 10 comparisons. In the following, we report on those of the main outcomes for which evidence was available. No subgroup analysis, such as by pinning methods, was viable.\nEleven heterogeneous trials involving 917 participants compared percutaneous pinning with plaster cast immobilisation after closed reduction of the fracture. The quality of the evidence was very low for all reported outcomes. Thus, we are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported function, measured using the DASH questionnaire, at six weeks or six months (incomplete data from one trial). Overall numbers of participants with complications were not reported. Redisplacement resulting in secondary treatment occurred on average in 12% (range 3.3% to 75%) of participants treated by cast alone (six trials) whereas pin tract infection requiring antibiotics and, often, early wire removal, occurred on average in 7.7% (range 0% to 15%) of pinning group participants (seven trials). We are uncertain whether pinning makes a difference to the incidence of complex regional pain syndrome, reported in four studies. Although two studies found finger stiffness after cast removal was less common after pinning (20% versus 36%), the treatment implications were not reported. Other reported complications were mainly surgery-related. Based on incomplete data or qualitative statements from only four studies, we are uncertain of the effects of pinning on grip strength at 12 months. We are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported quality of life at four months (one study).\nFive comparisons of different pinning methods were made by six trials in all. One of these trials, which reported results for 96 participants, compared Kapandji intrafocal pinning (2 or 3 wires) with early mobilisation versus trans-styloid fixation (2 wires) with six weeks cast immobilisation. We are uncertain whether Kapandji pinning slightly increases the risk of superficial radial nerve symptoms or complex regional pain syndrome, or whether it makes a difference in grip strength at 12 months (very low-quality evidence).\nTwo small trials using two distinct pinning techniques compared biodegradable pins versus metal pins in 70 participants. Although very low-quality evidence, the extra demands at surgery of insertion of biodegradable pins and excess of serious complications (e.g. severe osteolytic reactions) associated with biodegradable material are important findings.\nThree poorly-reported trials involving 168 participants compared burying of wire ends versus leaving them exposed. We are uncertain whether burying of wires reduces the incidence of superficial infection (very low-quality evidence). There is low-quality evidence that burying of wires may be associated with a higher risk of requiring more invasive treatment for wire removal.\nFour small trials compared different types or duration of postoperative immobilisation. Very low-quality evidence of small between-group differences in individual complications and grip strength at 17 weeks, means we are uncertain of the effects of positioning the wrist in dorsiflexion versus palmar flexion during cast immobilisation following pinning of redisplaced fractures (one trial; 60 participants). Three small heterogeneous trials compared cast immobilisation for one week (early mobilisation) versus four or six weeks after percutaneous pinning in 170 people. Although we note one trial using Kapandji pinning reported more complications in the early group, the very low-quality evidence means there is uncertainty of the effects of early mobilisation on overall and individual complications, or grip strength at 12 months.\nNo trials tested different methods for, or timing of, pin/wire removal.\nAuthors' conclusions\nOverall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone or associated treatment decisions such as method of pinning, burying or not of wire ends, wrist position and duration of immobilisation after pinning. Although very low-quality evidence, the serious complications associated with biodegradable materials is noteworthy. We advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment as these could help inform future research.\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": "Broken wrists are fractures at the lower end of the radius, one of the two forearm bones. Typically in older people, these can occur when people put out a hand to break a fall. The broken bones are often pushed apart, resulting in a 'displaced' fracture.\nFor most broken wrists, the bones can be moved back together (reduced) and held in place without an operation by a plaster cast for a few weeks. When fractures are unstable, the parts do not stay together. Another way of managing broken wrists is to hold the bones back in place with a surgical procedure, such as percutaneous pinning. This involves the insertion of pins or wires through the skin (percutaneous) to hold the bones in a proper position while they heal. In most pinning methods, pins or wires are used to fix the fragments together. In Kapandji pinning, the wires are placed to support the distal (lower end) fragment."
}
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query-laysum | 3066 | [
{
"role": "user",
"content": "Abstract: Background\nFollowing sexual abuse, children and young people may develop a range of psychological problems, including anxiety, depression, post-traumatic stress disorder (PTSD), and a range of behaviour problems. Those working with children and young people experiencing these problems may use one or more of a range of psychological approaches.\nObjectives\nTo assess the relative effectiveness of psychological interventions compared to other treatments or no treatment controls, to overcome psychological consequences of sexual abuse in children and young people up to 18 years of age.\nSecondary objectives\nTo rank psychotherapies according to their effectiveness.\nTo compare different ‘doses’ of the same intervention.\nSearch methods\nIn November 2022 we searched CENTRAL, MEDLINE, Embase, PsycINFO, 12 other databases and two trials registers. We reviewed the reference lists of included studies, alongside other work in the field, and communicated with the authors of included studies.\nSelection criteria\nWe included randomised controlled trials comparing psychological interventions for sexually abused children and young people up to 18 years old with other treatments or no treatments. Interventions included: cognitive behavioural therapy (CBT), psychodynamic therapy, family therapy, child centred therapy (CCT), and eye movement desensitisation and reprocessing (EMDR). We included both individual and group formats.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed the risk of bias for our primary outcomes (psychological distress/mental health, behaviour, social functioning, relationships with family and others) and secondary outcomes (substance misuse, delinquency, resilience, carer distress and efficacy).\nWe considered the effects of the interventions on all outcomes at post-treatment, six months follow-up and 12 months follow-up. For each outcome and time point with sufficient data, we performed random-effects network and pairwise meta-analyses to determine an overall effect estimate for each possible pair of therapies. Where meta-analysis was not possible, we report the summaries from single studies. Due to the low number of studies in each network, we did not attempt to determine the probabilities of each treatment being the most effective relative to the others for each outcome at each time point.\nWe rated the certainty of evidence with GRADE for each outcome.\nMain results\nWe included 22 studies (1478 participants) in this review. Most of the participants were female (range: 52% to 100%), and were mainly white. Limited information was provided on socioeconomic status of participants. Seventeen studies were conducted in North America, with the remaining studies conducted in the UK (N = 2), Iran (N = 1), Australia (N = 1) and Democratic Republic of Congo (N = 1). CBT was explored in 14 studies and CCT in eight studies; psychodynamic therapy, family therapy and EMDR were each explored in two studies. Management as usual (MAU) was the comparator in three studies and a waiting list was the comparator in five studies. For all outcomes, comparisons were informed by low numbers of studies (one to three per comparison), sample sizes were small (median = 52, range 11 to 229) and networks were poorly connected. Our estimates were all imprecise and uncertain.\nPrimary outcomes\nAt post-treatment, network meta-analysis (NMA) was possible for measures of psychological distress and behaviour, but not for social functioning. Relative to MAU, there was very low certainty evidence that CCT involving parent and child reduced PTSD (standardised mean difference (SMD) -0.87, 95% confidence intervals (CI) -1.64 to -0.10), and CBT with only the child reduced PTSD symptoms (SMD -0.96, 95% CI -1.72 to -0.20). There was no clear evidence of an effect of any therapy relative to MAU for other primary outcomes or at any other time point.\nSecondary outcomes\nCompared to MAU, there was very low certainty evidence that, at post-treatment, CBT delivered to the child and the carer might reduce parents' emotional reactions (SMD -6.95, 95% CI -10.11 to -3.80), and that CCT might reduce parents' stress. However, there is high uncertainty in these effect estimates and both comparisons were informed only by one study. There was no evidence that the other therapies improved any other secondary outcome.\nWe attributed very low levels of confidence for all NMA and pairwise estimates for the following reasons. Reporting limitations resulted in judgements of 'unclear' to 'high' risk of bias in relation to selection, detection, performance, attrition and reporting bias; the effect estimates we derived were imprecise, and small or close to no change; our networks were underpowered due to the low number of studies informing them; and whilst studies were broadly comparable with regard to settings, the use of a manual, the training of the therapists, the duration of treatment and number of sessions offered, there was considerable variability in the age of participants and the format in which the interventions were delivered (individual or group).\nAuthors' conclusions\nThere was weak evidence that both CCT (delivered to child and carer) and CBT (delivered to the child) might reduce PTSD symptoms at post-treatment. However, the effect estimates are uncertain and imprecise. For the remaining outcomes examined, none of the estimates suggested that any of the interventions reduced symptoms compared to management as usual.\nWeaknesses in the evidence base include the dearth of evidence from low- and middle-income countries. Further, not all interventions have been evaluated to the same extent, and there is little evidence regarding the effectiveness of interventions for male participants or those from different ethnicities. In 18 studies, the age ranges of participants ranged from 4 to 16 years old or 5 to 17 years old. This may have influenced the way in which the interventions were delivered, received, and consequently influenced outcomes.\nMany of the included studies evaluated interventions that were developed by members of the research team. In others, developers were involved in monitoring the delivery of the treatment. It remains the case that evaluations conducted by independent research teams are needed to reduce the potential for investigator bias.\nStudies addressing these gaps would help to establish the relative effectiveness of interventions currently used with this vulnerable population.\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 22 studies (1478 participants) and most of them were from North America. Fourteen of these examined the effectiveness of CBT and eight examined the effectiveness of CCT. Psychodynamic therapy, family therapy and EMDR were each examined in two studies. Management as usual was the comparator in three studies and a waiting list was the comparator in five studies."
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query-laysum | 3067 | [
{
"role": "user",
"content": "Abstract: Background\nSymptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.\nObjectives\nTo evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.\nSelection criteria\nWe included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.\nData collection and analysis\nTwo review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.\nMain results\nWe included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency.\nSix studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events.\nThere was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups.\nOne study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).\nAuthors' conclusions\nThis review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In this review, we compared atherectomy with the other treatment options described above. We also looked within the two groups to assess whether using drug-releasing balloons or stents impacted on participants' outcomes. We identified seven studies with a total of 527 participants.\nSix trials compared atherectomy against balloon angioplasty (372 participants, 427 treated lesions). We found no clear difference between the procedures when examining artery patency at six and 12 months, risk of death, initial procedure failure rates, need to re-treat the artery, risk of forming clots (embolisation), complication rates or risk of amputation. We found that atherectomy was associated with lower rates of emergency stenting during the procedure and lower balloon inflation pressures when compared with balloon angioplasty alone. We found no difference in results depending on whether the balloons were drug-releasing or not.\nOne study compared atherectomy against balloon angioplasty and primary stenting (155 participants and 155 treated lesions). This study did not report primary patency. We found no clear difference between the treatment arms in risk of death, complication rates, cardiovascular events and the need to re-treat the artery. This study found no initial procedure failure events,\nWe did not find any studies that compared bypass surgery against atherectomy."
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query-laysum | 3068 | [
{
"role": "user",
"content": "Abstract: Background\nThe removal of the acute appendix is one of the most frequently performed surgical procedures. Open surgery associated with therapeutic efficacy has been the treatment of choice for acute appendicitis. However, in consequence of the evolution of endoscopic surgery, the operation can also be performed with minimally invasive surgery. Due to smaller incisions, the laparoscopic approach may be associated with reduced postoperative pain, reduced wound infection rate, and shorter time until return to normal activity.\nThis is an update of the review published in 2010.\nObjectives\nTo compare the effects of laparoscopic appendectomy (LA) and open appendectomy (OA) with regard to benefits and harms.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE and Embase (9 February 2018). We identified proposed and ongoing studies from World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and EU Clinical Trials Register (9 February 2018). We handsearched reference lists of identified studies and the congress proceedings of endoscopic surgical societies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing LA versus OA in adults or children.\nData collection and analysis\nTwo review authors independently selected studies, assessed the risk of bias, and extracted data. We performed the meta-analyses using Review Manager 5. We calculated the Peto odds ratio (OR) for very rare outcomes, and the mean difference (MD) for continuous outcomes (or standardised mean differences (SMD) if researchers used different scales such as quality of life) with 95% confidence intervals (CI). We used GRADE to rate the quality of the evidence.\nMain results\nWe identified 85 studies involving 9765 participants. Seventy-five trials included 8520 adults and 10 trials included 1245 children. Most studies had risk of bias issues, with attrition bias being the largest source across studies due to incomplete outcome data.\nIn adults, pain intensity on day one was reduced by 0.75 cm on a 10 cm VAS after LA (MD -0.75, 95% CI -1.04 to -0.45; 20 RCTs; 2421 participants; low-quality evidence). Wound infections were less likely after LA (Peto OR 0.42, 95% CI 0.35 to 0.51; 63 RCTs; 7612 participants; moderate-quality evidence), but the incidence of intra-abdominal abscesses was increased following LA (Peto OR 1.65, 95% CI 1.12 to 2.43; 53 RCTs; 6677 participants; moderate-quality evidence).\nThe length of hospital stay was shortened by one day after LA (MD -0.96, 95% CI -1.23 to -0.70; 46 RCTs; 5127 participant; low-quality evidence). The time until return to normal activity occurred five days earlier after LA than after OA (MD -4.97, 95% CI -6.77 to -3.16; 17 RCTs; 1653 participants; low-quality evidence). Two studies showed better quality of life scores following LA, but used different scales, and therefore no pooled estimates were presented. One used the SF-36 questionnaire two weeks after surgery and the other used the Gastro-intestinal Quality of Life Index six weeks and six months after surgery (both low-quality evidence).\nIn children, we found no differences in pain intensity on day one (MD -0.80, 95% CI -1.65 to 0.05; 1 RCT; 61 participants; low-quality evidence), intra-abdominal abscesses after LA (Peto OR 0.54, 95% CI 0.24 to 1.22; 9 RCTs; 1185 participants; low-quality evidence) or time until return to normal activity (MD -0.50, 95% CI -1.30 to 0.30; 1 RCT; 383 participants; moderate-quality evidence). However, wound infections were less likely after LA (Peto OR 0.25, 95% CI 0.15 to 0.42; 10 RCTs; 1245 participants; moderate-quality evidence) and the length of hospital stay was shortened by 0.8 days after LA (MD -0.81, 95% CI -1.01 to -0.62; 6 RCTs; 316 participants; low-quality evidence). Quality of life was not reported in any of the included studies.\nAuthors' conclusions\nExcept for a higher rate of intra-abdominal abscesses after LA in adults, LA showed advantages over OA in pain intensity on day one, wound infections, length of hospital stay and time until return to normal activity in adults. In contrast, LA showed advantages over OA in wound infections and length of hospital stay in children. Two studies reported better quality of life scores in adults. No study reported this outcome in children. However, the quality of evidence ranged from very low to moderate and some of the clinical effects of LA were small and of limited clinical relevance. Future studies with low risk of bias should investigate, in particular, the quality of life in children.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effects of the open operation technique and the minimally invasive procedure in persons with suspected appendicitis."
}
]
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query-laysum | 3069 | [
{
"role": "user",
"content": "Abstract: Background\nSepsis is a life-threatening condition that is usually diagnosed when a patient has a suspected or documented infection, and meets two or more criteria for systemic inflammatory response syndrome (SIRS). The incidence of sepsis is higher among people admitted to critical care settings such as the intensive care unit (ICU) than among people in other settings. If left untreated sepsis can quickly worsen; severe sepsis has a mortality rate of 40% or higher, depending on definition. Recognition of sepsis can be challenging as it usually requires patient data to be combined from multiple unconnected sources, and interpreted correctly, which can be complex and time consuming to do. Electronic systems that are designed to connect information sources together, and automatically collate, analyse, and continuously monitor the information, as well as alerting healthcare staff when pre-determined diagnostic thresholds are met, may offer benefits by facilitating earlier recognition of sepsis and faster initiation of treatment, such as antimicrobial therapy, fluid resuscitation, inotropes, and vasopressors if appropriate. However, there is the possibility that electronic, automated systems do not offer benefits, or even cause harm. This might happen if the systems are unable to correctly detect sepsis (meaning that treatment is not started when it should be, or it is started when it shouldn't be), or healthcare staff may not respond to alerts quickly enough, or get 'alarm fatigue' especially if the alarms go off frequently or give too many false alarms.\nObjectives\nTo evaluate whether automated systems for the early detection of sepsis can reduce the time to appropriate treatment (such as initiation of antibiotics, fluids, inotropes, and vasopressors) and improve clinical outcomes in critically ill patients in the ICU.\nSearch methods\nWe searched CENTRAL; MEDLINE; Embase; CINAHL; ISI Web of science; and LILACS, clinicaltrials.gov, and the World Health Organization trials portal. We searched all databases from their date of inception to 18 September 2017, with no restriction on country or language of publication.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared automated sepsis-monitoring systems to standard care (such as paper-based systems) in participants of any age admitted to intensive or critical care units for critical illness. We defined an automated system as any process capable of screening patient records or data (one or more systems) automatically at intervals for markers or characteristics that are indicative of sepsis. We defined critical illness as including, but not limited to postsurgery, trauma, stroke, myocardial infarction, arrhythmia, burns, and hypovolaemic or haemorrhagic shock. We excluded non-randomized studies, quasi-randomized studies, and cross-over studies . We also excluded studies including people already diagnosed with sepsis.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were: time to initiation of antimicrobial therapy; time to initiation of fluid resuscitation; and 30-day mortality. Secondary outcomes included: length of stay in ICU; failed detection of sepsis; and quality of life. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included three RCTs in this review. It was unclear if the RCTs were three separate studies involving 1199 participants in total, or if they were reports from the same study involving fewer participants. We decided to treat the studies separately, as we were unable to make contact with the study authors to clarify.\nAll three RCTs are of very low study quality because of issues with unclear randomization methods, allocation concealment and uncertainty of effect size. Some of the studies were reported as abstracts only and contained limited data, which prevented meaningful analysis and assessment of potential biases.\nThe studies included participants who all received automated electronic monitoring during their hospital stay. Participants were randomized to an intervention group (automated alerts sent from the system) or to usual care (no automated alerts sent from the system).\nEvidence from all three studies reported 'Time to initiation of antimicrobial therapy'. We were unable to pool the data, but the largest study involving 680 participants reported median time to initiation of antimicrobial therapy in the intervention group of 5.6 hours (interquartile range (IQR) 2.3 to 19.7) in the intervention group (n = not stated) and 7.8 hours (IQR 2.5 to 33.1) in the control group (n = not stated).\nNo studies reported 'Time to initiation of fluid resuscitation' or the adverse event 'Mortality at 30 days'. However very low-quality evidence was available where mortality was reported at other time points. One study involving 77 participants reported 14-day mortality of 20% in the intervention group and 21% in the control group (numerator and denominator not stated). One study involving 442 participants reported mortality at 28 days, or discharge was 14% in the intervention group and 10% in the control group (numerator and denominator not reported). Sample sizes were not reported adequately for these outcomes and so we could not estimate confidence intervals.\nVery low-quality evidence from one study involving 442 participants reported 'Length of stay in ICU'. Median length of stay was 3.0 days in the intervention group (IQR = 2.0 to 5.0), and 3.0 days (IQR 2.0 to 4.0 in the control).\nVery low-quality evidence from one study involving at least 442 participants reported the adverse effect 'Failed detection of sepsis'. Data were only reported for failed detection of sepsis in two participants and it wasn't clear which group(s) this outcome occurred in.\nNo studies reported 'Quality of life'.\nAuthors' conclusions\nIt is unclear what effect automated systems for monitoring sepsis have on any of the outcomes included in this review. Very low-quality evidence is only available on automated alerts, which is only one component of automated monitoring systems. It is uncertain whether such systems can replace regular, careful review of the patient's condition by experienced healthcare staff.\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": "Results of this review show limited, very low-quality evidence, which has prevented us from drawing meaningful conclusions. It is unclear what effect automated systems for monitoring sepsis have on any outcomes included in this review, and therefore we are uncertain if automated sepsis monitoring is beneficial or not. Additional, high-quality evidence is needed to help address our review question."
}
]
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query-laysum | 3070 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent treatments for amblyopia, typically patching or pharmacological blurring, have limited success. Less than two-thirds of children achieve good acuity of 0.20 logMAR in the amblyopic eye, with limited improvement of stereopsis, and poor adherence to treatment. A new approach, based on presentation of movies or computer games separately to each eye, may yield better results and improve adherence. These treatments aim to balance the input of visual information from each eye to the brain.\nObjectives\nTo determine whether binocular treatments in children, aged three to eight years, with unilateral amblyopia result in better visual outcomes than conventional patching or pharmacological blurring treatment.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to 19 November 2020, with no language restrictions.\nSelection criteria\nTwo review authors independently screened the results of the search for relevant studies. We included randomised controlled trials (RCTs) that enrolled children between the ages of three and eight years old with unilateral amblyopia. Amblyopia was classed as present when the best-corrected visual acuity (BCVA) was worse than 0.200 logMAR in the amblyopic eye, with BCVA 0.200 logMAR or better in the fellow eye, in the presence of an amblyogenic risk factor, such as anisometropia, strabismus, or both. To be eligible, children needed to have undergone cycloplegic refraction and ophthalmic examination, including fundal examination and optical treatment, if indicated, with stable BCVA in the amblyopic eye despite good adherence with wearing glasses. We included any type of binocular viewing intervention, on any device (e.g. computer monitors viewed with liquid-crystal display shutter glasses; hand-held screens, including mobile phones with lenticular prism overlay; or virtual reality displays). Control groups received standard amblyopia treatment, which could include patching or pharmacological blurring of the better-seeing eye. We included full-time (all waking hours) and part-time (between 1 and 12 hours a day) patching regimens.\nWe excluded children who had received any treatment other than optical treatment; and studies with less than 8-week follow-up.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome of the review was the change from baseline of distance BCVA in the amblyopic eye after 16 (± 2) weeks of treatment, measured in logMAR units on an age-appropriate acuity test.\nMain results\nWe identified one eligible RCT of conventional patching treatment versus novel binocular treatment, and analysed a subset of 68 children who fulfilled the age criterion of this review. We obtained data for the mean change in amblyopic eye visual acuity, adverse events (diplopia), and adherence to prescribed treatment at 8- and 16-week follow-up intervals, though no data were available for change in BCVA after 52 weeks. Risk of bias for the included study was considered to be low.\nThe certainty of evidence for the visual acuity outcomes at 8 and 16 weeks of treatment and adherence to the study intervention was rated moderate using the GRADE criteria, downgrading by one level due to imprecision. The certainty of evidence was downgraded by two levels and rated low for the proportion of participants reporting adverse events due to the sample size.\nAcuity improved in the amblyopic eye in both the binocular and patching groups following 16 weeks of treatment (improvement of -0.21 logMAR in the binocular group and -0.24 logMAR in the patching group), mean difference (MD) 0.03 logMAR (95% confidence interval (CI) -0.10 to 0.04; 63 children). This difference was non-significant and the improvements in both the binocular and patching groups are also considered clinically similar.\nFollowing 8 weeks of treatment, acuity improved in both the binocular and patching groups (improvement of -0.18 logMAR in the patching group compared to -0.16 logMAR improvement in the binocular-treatment group) (MD 0.02, 95% CI -0.04 to 0.08). Again this difference was statistically non-significant, and the differences observed between the patching and binocular groups are also clinically non-significant. No adverse event of permanent diplopia was reported.\nAdherence was higher in the patching group (47% of participants in the iPad group achieved over 75% compliance compared with 90% of the patching group).\nData were not available for changes in stereopsis nor for contrast sensitivity following treatment.\nAuthors' conclusions\nCurrently, there is only one RCT that offers evidence of the safety and effectiveness of binocular treatment.\nThe authors are moderately confident that after 16 weeks of treatment, the gain in amblyopic eye acuity with binocular treatment is likely comparable to that of conventional patching treatment. However, due to the limited sample size and lack of long term (52 week) follow-up data, it is not yet possible to draw robust conclusions regarding the overall safety and sustained effectiveness of binocular treatment.\nFurther research, using acknowledged methods of visual acuity and stereoacuity assessment with known reproducibility, is required to inform decisions about the implementation of binocular treatments for amblyopia in clinical practice, and should incorporate longer term follow-up to establish the effectiveness of binocular treatment. Randomised controlled trials should also include outcomes reported by users, adherence to prescribed treatment, and recurrence of amblyopia after cessation of treatment.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years."
}
]
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query-laysum | 3071 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacotherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication when used as an add-on treatment for drug-resistant epilepsy. In January 2009, rufinamide was approved by the US Food and Drug Administration for the treatment of children four years of age and older with Lennox-Gastaut syndrome. It is also approved as an add-on treatment for adults and adolescents with focal seizures.\nThis is an updated version of the original Cochrane Review published in 2018.\nObjectives\nTo evaluate the efficacy and tolerability of rufinamide when used as an add-on treatment for people with drug-resistant epilepsy.\nSearch methods\nWe imposed no language restrictions. We contacted the manufacturers of rufinamide and authors in the field to identify any relevant unpublished studies.\nSelection criteria\nRandomised, double-blind, placebo-controlled, add-on trials of rufinamide, recruiting people (of any age or gender) with drug-resistant epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 50% or greater reduction in seizure frequency (primary outcome); seizure freedom; treatment withdrawal; and adverse effects (secondary outcomes). Primary analyses were intention-to-treat (ITT) and we presented summary risk ratios (RRs) with 95% confidence intervals (CIs). We evaluated dose response in regression models. We carried out a risk of bias assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach.\nMain results\nThe review included six trials, representing 1759 participants. Four trials (1563 participants) included people with uncontrolled focal seizures. Two trials (196 participants) included individuals with established Lennox-Gastaut syndrome. Overall, the age of adults ranged from 18 to 80 years and the age of children ranged from 4 to 16 years. Baseline phases ranged from 28 to 56 days and double-blind phases from 84 to 96 days. Five of the six included trials described adequate methods of concealment of randomisation, and only three described adequate blinding. All analyses were by ITT. Overall, five studies were at low risk of bias and one had unclear risk of bias due to lack of reported information around study design. All trials were sponsored by the manufacturer of rufinamide and therefore were at high risk of funding bias.\nThe overall RR for 50% or greater reduction in seizure frequency was 1.79 (95% CI 1.44 to 2.22; 6 randomised controlled trials (RCTs), 1759 participants; moderate-certainty evidence), indicating that rufinamide (plus conventional AED) was significantly more effective than placebo (plus conventional AED) in reducing seizure frequency by at least 50% when added to conventionally used AEDs in people with drug-resistant focal epilepsy. Data from only one study (73 participants) reported seizure freedom: RR 1.32 (95% CI 0.36 to 4.86; 1 RCT, 73 participants; moderate-certainty evidence). The overall RR for treatment withdrawal (for any reason and due to AED) was 1.83 (95% CI 1.45 to 2.31; 6 RCTs, 1759 participants; moderate-certainty evidence), showing that rufinamide was significantly more likely to be withdrawn than placebo. Most adverse effects were significantly more likely to occur in the rufinamide-treated group. Adverse events significantly associated with rufinamide were headache, dizziness, somnolence, vomiting, nausea, fatigue, and diplopia. The RRs for these adverse effects were as follows: headache 1.36 (95% Cl 1.08 to 1.69; 3 RCTs, 1228 participants; high-certainty evidence); dizziness 2.52 (95% Cl 1.90 to 3.34; 3 RCTs, 1295 participants; moderate-certainty evidence); somnolence 1.94 (95% Cl 1.44 to 2.61; 6 RCTs, 1759 participants; moderate-certainty evidence); vomiting 2.95 (95% Cl 1.80 to 4.82; 4 RCTs, 777 participants; low-certainty evidence); nausea 1.87 (95% Cl 1.33 to 2.64; 3 RCTs, 1295 participants; moderate-certainty evidence); fatigue 1.46 (95% Cl 1.08 to 1.97; 3 RCTs, 1295 participants; moderate-certainty evidence); and diplopia 4.60 (95% Cl 2.53 to 8.38; 3 RCTs, 1295 participants; low-certainty evidence). There was no important heterogeneity between studies for any outcomes. Overall, we assessed the evidence as moderate to low certainty due to wide CIs and potential risk of bias from some studies contributing to the analysis.\nAuthors' conclusions\nFor people with drug-resistant focal epilepsy, rufinamide when used as an add-on treatment was effective in reducing seizure frequency. However, the trials reviewed were of relatively short duration and provided no evidence for long-term use of rufinamide. In the short term, rufinamide as an add-on was associated with several adverse events. This review focused on the use of rufinamide in drug-resistant focal epilepsy, and the results cannot be generalised to add-on treatment for generalised epilepsies. Likewise, no inference can be made about the effects of rufinamide when used as monotherapy.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Adding rufinamide to an antiepileptic medicine probably reduced seizures more than a placebo, but probably caused more unwanted effects (in the short term); more people stopped add-on rufinamide treatment."
}
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query-laysum | 3072 | [
{
"role": "user",
"content": "Abstract: Background\nAcute pain frequently occurs after surgical procedures. Nicotine has been explored as an adjunctive medication for management of postoperative pain.\nObjectives\nTo assess the effect of transdermal or intranasal nicotine administration on postoperative pain, opioid analgesic use, and opioid-related adverse events.\nSearch methods\nWe searched MEDLINE (1966 to 20 March 2014), the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 3), EMBASE (1980 to 20 March 2014), and also databases of ongoing trials (www.controlled-trials.com/ and http://clinicaltrials.gov/). We re-ran the search on 28 April 2015. We will assess the one study of interest when we update the review.\nSelection criteria\nWe included randomized, placebo-controlled clinical trials that evaluated the effects of perioperative (pre-, intra-, or postoperative) administration of nicotine on postoperative pain, opioid use, and opioid-related adverse events. We excluded all other studies.\nData collection and analysis\nTwo authors independently screened all titles and abstracts for eligibility and documented reasons for exclusion. In case of disagreement, a third author decided on the inclusion or exclusion of a trial report. When additional information was needed in order to decide if a trial should be included, one of the authors contacted the corresponding author of the trial in question.\nMain results\nNine trials (666 participants) evaluated nicotine for postoperative pain. Nicotine may reduce postoperative pain scores at 24 hours by a small amount compared with placebo (eight trials, mean difference -0.88 on a 0 to 10 scale, 95% confidence interval (CI) -1.58 to -0.18; low quality evidence). The effect on pain at one hour and 12 hours postoperatively was less certain (very low quality evidence). Statistical heterogeneity was substantial and not adequately explained by stratification of trials according to type of surgical procedure, smoking status, mode of nicotine administration, timing of administration, or assessed risk of bias. Excluding one trial at high risk of bias resulted in similar findings. The effect of nicotine on postoperative opioid use was uncertain due to small number of participants in the studies. Nicotine probably increases the risk of postoperative nausea (seven trials, RR 1.24, 95% CI 1.03 to 1.50; moderate quality evidence). Three trials assessed sedation but the effect is very uncertain due to the very low quality of evidence. We found no evidence that nicotine increased the risk of vomiting (seven studies, risk difference (RD) 0.03, 95% CI -0.04 to 0.09; low quality evidence). The results from one single small trial were insufficient to establish whether nicotine led to an earlier hospital discharge (very low quality evidence).\nAuthors' conclusions\nBased on evidence of generally low quality, nicotine may reduce postoperative pain at 24 hours compared with placebo, but the effects were relatively small (less than 1 point on a 10 point pain scale) and there was substantial heterogeneity in the results of our analyses. Nicotine does not appear to reduce postoperative use of opioids or opioid-related adverse events but probably increases the risk of nausea. More research is needed to determine the effectiveness of nicotine for postoperative pain and to understand the optimal timing, dose, and method of delivery of nicotine.\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": "Our results indicated that there is low quality evidence that nicotine use results in slightly lower postoperative pain scores 24 hours after surgery. At one hour and 12 hours postoperatively the effect was less certain. Nicotine appeared not to reduce use of opioids at 60 minutes or 24 hours, neither was there evidence that it reduced sedation or vomiting. Nicotine was associated with higher risk of nausea than placebo, and this may limit its use. There was not enough data to evaluate the effects of nicotine use on other side effects associated with opioids, including respiratory depression, or the effects of nicotine use on length of hospital stay following surgery."
}
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query-laysum | 3073 | [
{
"role": "user",
"content": "Abstract: Background\nRupture of an intracranial aneurysm causes aneurysmal subarachnoid haemorrhage, which is one of the most devastating clinical conditions. It can be classified into five Grades using the Hunt-Hess or World Federation of Neurological Surgeons (WFNS) scale. Grades 4 and 5 predict poor prognosis and are known as 'poor grade', while grade 1, 2, and 3 are known as 'good grade'. Disturbances of intracranial homeostasis and brain metabolism are known to play certain roles in the sequelae. Hypothermia has a long history of being used to reduce metabolic rate, thereby protecting organs where metabolism is disturbed, and may potentially cause harm.\nObjectives\nTo assess the effect of intraoperative mild hypothermia on postoperative death and neurological deficits in people with ruptured or unruptured intracranial aneurysms.\nSearch methods\nWe updated the search in the Cochrane Stroke Group Trials Register (August 2015), the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 8), WHO International Clinical Trials Registry Platform (ICTRP; December 2015), MEDLINE (1950 to September 2015), EMBASE (1980 to September 2015), Science Citation Index (1900 to September 2015), and 11 Chinese databases (September 2015). We also searched ongoing trials registers (September 2015) and scanned reference lists of retrieved records.\nSelection criteria\nWe included only randomised controlled trials that compared intraoperative mild hypothermia (32°C to 35°C) with control (no hypothermia) in people with ruptured or unruptured intracranial aneurysms.\nData collection and analysis\nTwo review authors independently selected trials and assessed the risk of bias for each included study. We presented data as risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CI).\nMain results\nWe included three studies, enrolling 1158 participants. Each study reported an increased rate of recovery with intraoperative mild hypothermia, but the effect sizes were not sufficient for certainty. A total of 1086 of the 1158 participants (93.8%) had good grade aneurysmal subarachnoid haemorrhage. Seventy-six of 577 participants (13.1%) who received hypothermia and 93 of 581 participants (16.0%) who did not receive hypothermia were dead or dependent (RR 0.82; 95% CI 0.62 to 1.09; RD -0.03; 95% CI -0.07 to 0.01, moderate-quality evidence) after three months.\nReported unfavourable outcomes did not differ between participants with or without hypothermia. The quality of evidence for these outcomes remains unclear because the outcomes were reported in a variety of ways. No decompressive craniectomy or corticectomy was reported. Thirty-six of 577 (6.2%) participants with hypothermia and 40 of 581 (6.9%) participants without hypothermia had infarction. Thirty-four of 577 (6%) participants with hypothermia and 32 of the 581 (5.5%) participants without hypothermia had clinical vasospasm (temporary deficits).\nDuration of hospital stay was not reported. Only one study with 112 participants reported discharge destinations: 43 of 55 (78.2%) participants with hypothermia and 39 of 57 (68.4%) participants in the control group were discharged home. The remaining participants were discharged to other facilities.\nThirty-nine of 577 (6.8%) participants with hypothermia and 39 of 581 (6.7%) participants without hypothermia had infections. Six of 577 (1%) participants with hypothermia and 6 of 581 (1%) participants without hypothermia had cardiac arrhythmia.\nAuthors' conclusions\nIt remains possible that intraoperative mild hypothermia could prevent death or dependency in activities of daily living in people with good grade aneurysmal subarachnoid haemorrhage. However, the confidence intervals around this estimate include the possibility of both benefit and harm. There was insufficient information to draw any conclusions about the effects of intraoperative mild hypothermia in people with poor grade aneurysmal subarachnoid haemorrhage or without subarachnoid haemorrhage. We did not identify any reliable evidence to support the routine use of intraoperative mild hypothermia. A high-quality randomised clinical trial of intraoperative mild hypothermia for postoperative neurological deficits in people with poor grade aneurysmal subarachnoid haemorrhage might be feasible.\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 do not have enough data to be certain about the effect of cooling on death or dependency. The evidence for other outcomes was more uncertain, since we could not combine the data due to variation in the definition and reporting of outcome data. Data in our analyses were primarily from one high quality trial on good grade participants."
}
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query-laysum | 3074 | [
{
"role": "user",
"content": "Abstract: Background\nRenin inhibitors (RIs) reduce blood pressure more than placebo, with the magnitude of this effect thought to be similar to that for angiotensin converting enzyme (ACE) inhibitors. However, a drug's efficacy in lowering blood pressure cannot be considered as a definitive indicator of its effectiveness in reducing mortality and morbidity. The effectiveness and safety of RIs compared to ACE inhibitors in treating hypertension is unknown.\nObjectives\nTo evaluate the benefits and harms of renin inhibitors compared to ACE inhibitors in people with primary hypertension.\nSearch methods\nThe Cochrane Hypertension Group Information Specialist searched the following databases for randomized controlled trials up to August 2020: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers about further published and unpublished work. The searches had no language restrictions.\nSelection criteria\nWe included randomized, active-controlled, double-blinded studies (RCTs) with at least four weeks follow-up in people with primary hypertension, which compared renin inhibitors with ACE inhibitors and reported morbidity, mortality, adverse events or blood pressure outcomes. We excluded people with proven secondary hypertension.\nData collection and analysis\nTwo review authors independently selected the included trials, evaluated the risks of bias and entered the data for analysis.\nMain results\nWe include 11 RCTs involving 13,627 participants, with a mean baseline age from 51.5 to 74.2 years. Follow-up duration ranged from four weeks to 36.6 months.\nThere was no difference between RIs and ACE inhibitors for the outcomes: all-cause mortality: risk ratio (RR) 1.05, 95% confidence interval (CI) 0.93 to 1.18; 5 RCTs, 5962 participants; low-certainty evidence; total myocardial infarction: RR 0.86, 95% CI 0.22 to 3.39; 2 RCTs, 957 participants; very low-certainty evidence; adverse events: RR 0.98, 95% CI 0.93 to 1.03; 10 RTCs, 6007 participants; moderate-certainty evidence; serious adverse events: RR 1.21, 95% CI 0.89 to 1.64; 10 RTCs, 6007 participants; low-certainty evidence; and withdrawal due to adverse effects: RR 0.85, 95% CI 0.68 to 1.06; 10 RTCs, 6008 participants; low-certainty evidence. No data were available for total cardiovascular events, heart failure, stroke, end-stage renal disease or change in heart rate. Low-certainty evidence suggested that RIs reduced systolic blood pressure: mean difference (MD) −1.72, 95% CI −2.47 to −0.97; 9 RCTs, 5001 participants; and diastolic blood pressure: MD −1.18, 95% CI −1.65 to −0.72; 9 RCTs, 5001 participants, to a greater extent than ACE inhibitors, but we judged this to be more likely due to bias than a true effect.\nAuthors' conclusions\nFor the treatment of hypertension, we have low certainty that renin inhibitors (RI) and angiotensin converting enzyme (ACE) inhibitors do not differ for all-cause mortality and myocardial infarction. We have low to moderate certainty that they do not differ for adverse events. Small reductions in blood pressure with renin inhibitors compared to ACE inhibitors are of low certainty. More independent, large, long-term trials are needed to compare RIs with ACE inhibitors, particularly assessing morbidity and mortality outcomes, but also on blood pressure-lowering effect.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hypertension is a worldwide public-health challenge associated with high levels of occurrence and risks of circulatory and kidney disease. RIs were introduced into clinical use for hypertension in 2007. ACE inhibitors are widely prescribed for hypertension. However, the comparative effectiveness and safety of RIs and ACE inhibitors is not known."
}
]
|
query-laysum | 3075 | [
{
"role": "user",
"content": "Abstract: Background\nTelerehabilitation, an emerging method, extends rehabilitative care beyond the hospital, and facilitates multifaceted, often psychotherapeutic approaches to modern management of patients using telecommunication technology at home or in the community. Although a wide range of telerehabilitation interventions are trialed in persons with multiple sclerosis (pwMS), evidence for their effectiveness is unclear.\nObjectives\nTo investigate the effectiveness and safety of telerehabilitation intervention in pwMS for improved patient outcomes. Specifically, this review addresses the following questions: does telerehabilitation achieve better outcomes compared with traditional face-to-face intervention; and what types of telerehabilitation interventions are effective, in which setting and influence which specific outcomes (impairment, activity limitation and participation)?\nSearch methods\nWe performed a literature search using the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group Specialised Register( 9 July, 2014.) We handsearched the relevant journals and screened the reference lists of identified studies, and contacted authors for additional data.\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) that reported telerehabilitation intervention/s in pwMS and compared them with some form of control intervention (such as lower level or different types of intervention, minimal intervention, waiting-list controls or no treatment (or usual care); interventions given in different settings) in adults with MS.\nData collection and analysis\nTwo review authors independently selected studies and extracted data. Three review authors assessed the methodological quality of studies using the GRADEpro software (GRADEpro 2008) for best-evidence synthesis. A meta-analysis was not possible due to marked methodological, clinical and statistical heterogeneity between included trials and between measurement tools used. Hence, we performed a best-evidence synthesis using a qualitative analysis.\nMain results\nNine RCTs, one with two reports, (N = 531 participants, 469 included in analyses) investigated a variety of telerehabilitation interventions in adults with MS. The mean age of participants varied from 41 to 52 years (mean 46.5 years) and mean years since diagnosis from 7.7 to 19.0 years (mean 12.3 years). The majority of the participants were women (proportion ranging from 56% to 87%, mean 74%) and with a relapsing-remitting course of MS. These interventions were complex, with more than one rehabilitation component and included physical activity, educational, behavioural and symptom management programmes.\nAll studies scored 'low' on the methodological quality assessment. Overall, the review found 'low-level' evidence for telerehabilitation interventions in reducing short-term disability and symptoms such as fatigue. There was also 'low-level' evidence supporting telerehabilitation in the longer term for improved functional activities, impairments (such as fatigue, pain, insomnia); and participation measured by quality of life and psychological outcomes. There were limited data on process evaluation (participants'/therapists' satisfaction) and no data available for cost effectiveness. There were no adverse events reported as a result of telerehabilitation interventions.\nAuthors' conclusions\nThere is currently limited evidence on the efficacy of telerehabilitation in improving functional activities, fatigue and quality of life in adults with MS. A range of telerehabilitation interventions might be an alternative method of delivering services in MS populations. There is insufficient evidence to support on what types of telerehabilitation interventions are effective, and in which setting. More robust trials are needed to build evidence for the clinical and cost effectiveness of these interventions.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review looked for evidence on how telerehabilitation interventions work in adults with MS. We searched widely for randomised controlled trials (RCTs), a particular kind of study where participants are placed in treatment groups by chance (that is, randomly) because in most settings these provide the highest quality evidence. We were interested in studies that compared a telerehabilitation programme with standard or minimal care, or with different kinds of rehabilitation programmes."
}
]
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query-laysum | 3076 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers (also known as pressure injuries, pressure sores and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Specific kinds of beds, overlays and mattresses are widely used with the aim of preventing and treating pressure ulcers.\nObjectives\nTo summarise evidence from Cochrane Reviews that assess the effects of beds, overlays and mattresses on reducing the incidence of pressure ulcers and on increasing pressure ulcer healing in any setting and population.\nTo assess the relative effects of different types of beds, overlays and mattresses for reducing the incidence of pressure ulcers and increasing pressure ulcer healing in any setting and population.\nTo cumulatively rank the different treatment options of beds, overlays and mattresses in order of their effectiveness in pressure ulcer prevention and treatment.\nMethods\nIn July 2020, we searched the Cochrane Library. Cochrane Reviews reporting the effectiveness of beds, mattresses or overlays for preventing or treating pressure ulcers were eligible for inclusion in this overview. Two review authors independently screened search results and undertook data extraction and risk of bias assessment using the ROBIS tool. We summarised the reported evidence in an overview of reviews. Where possible, we included the randomised controlled trials from each included review in network meta-analyses. We assessed the relative effectiveness of beds, overlays and mattresses for preventing or treating pressure ulcers and their probabilities of being, comparably, the most effective treatment. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe include six Cochrane Reviews in this overview of reviews, all at low or unclear risk of bias.\nPressure ulcer prevention: four reviews (of 68 studies with 18,174 participants) report direct evidence for 27 pairwise comparisons between 12 types of support surface on the following outcomes: pressure ulcer incidence, time to pressure ulcer incidence, patient comfort response, adverse event rates, health-related quality of life, and cost-effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty.\n(1) Pressure ulcer incidence: our overview includes direct evidence for 27 comparisons that mostly (19/27) have very low-certainty evidence concerning reduction of pressure ulcer risk. We included 40 studies (12,517 participants; 1298 participants with new ulcers) in a network meta-analysis involving 13 types of intervention. Data informing the network are sparse and this, together with the high risk of bias in most studies informing the network, means most network contrasts (64/78) yield evidence of very low certainty. There is low-certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces (e.g. static air overlays) (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.29 to 0.75), alternating pressure (active) air surfaces (e.g. alternating pressure air mattresses, large-celled ripple mattresses) (RR 0.63, 95% CI 0.42 to 0.93), and reactive gel surfaces (e.g. gel pads used on operating tables) (RR 0.47, 95% CI 0.22 to 1.01) may reduce pressure ulcer incidence. The ranking of treatments in terms of effectiveness is also of very low certainty for all interventions. It is unclear which treatment is best for preventing ulceration.\n(2) Time to pressure ulcer incidence: four reviews had direct evidence on this outcome for seven comparisons. We included 10 studies (7211 participants; 699 participants with new ulcers) evaluating six interventions in a network meta-analysis. Again, data from most network contrasts (13/15) are of very low certainty. There is low-certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces may reduce the hazard of developing new pressure ulcers (hazard ratio (HR) 0.20, 95% CI 0.04 to 1.05). The ranking of all support surfaces for preventing pressure ulcers in terms of time to healing is uncertain.\n(3) Cost-effectiveness: this overview includes direct evidence for three comparisons. For preventing pressure ulcers, alternating pressure air surfaces are probably more cost-effective than foam surfaces (moderate-certainty evidence).\nPressure ulcer treatment: two reviews (of 12 studies with 972 participants) report direct evidence for five comparisons on: complete pressure ulcer healing, time to complete pressure ulcer healing, patient comfort response, adverse event rates, and cost-effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty.\n(1) Complete pressure ulcer healing: our overview includes direct evidence for five comparisons. There is uncertainty about the relative effects of beds, overlays and mattresses on ulcer healing. The corresponding network meta-analysis (with four studies, 397 participants) had only three direct contrasts and a total of six network contrasts. Again, most network contrasts (5/6) have very low-certainty evidence. There was low-certainty evidence that more people with pressure ulcers may heal completely using reactive air surfaces than using foam surfaces (RR 1.32, 95% CI 0.96 to 1.80). We are uncertain which surfaces have the highest probability of being the most effective (all very low-certainty evidence).\n(2) Time to complete pressure ulcer healing: this overview includes direct evidence for one comparison: people using reactive air surfaces may be more likely to have healed pressure ulcers compared with those using foam surfaces in long-term care settings (HR 2.66, 95% CI 1.34 to 5.17; low-certainty evidence).\n(3) Cost-effectiveness: this overview includes direct evidence for one comparison: compared with foam surfaces, reactive air surfaces may cost an extra 26 US dollars for every ulcer-free day in the first year of use in long-term care settings (low-certainty evidence).\nAuthors' conclusions\nCompared with foam surfaces, reactive air surfaces may reduce pressure ulcer risk and may increase complete ulcer healing. Compared with foam surfaces, alternating pressure air surfaces may reduce pressure ulcer risk and are probably more cost-effective in preventing pressure ulcers. Compared with foam surfaces, reactive gel surfaces may reduce pressure ulcer risk, particularly for people in operating rooms and long-term care settings. There are uncertainties for the relative effectiveness of other support surfaces for preventing and treating pressure ulcers, and their efficacy ranking.\nMore high-quality research is required; for example, for the comparison of reactive air surfaces with alternating pressure air surfaces. Future studies should consider time-to-event outcomes and be designed to minimise any risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"What are pressure ulcers?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Pressure ulcers (also known as pressure sores or bed sores) are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers."
}
]
|
query-laysum | 3077 | [
{
"role": "user",
"content": "Abstract: Background\nThe term \"strabismus\" describes misalignment of the eyes. One or both eyes may deviate inward, outward, upward, or downward. Dissociated vertical deviation (DVD) is a well-recognized type of upward drifting of one or both eyes, which can occur in children or adults. DVD often develops in the context of infantile- or childhood-onset horizontal strabismus, either esotropia (inward-turning) or exotropia (outward-turning). For some individuals, DVD remains controlled and can only be detected during clinical testing. For others, DVD becomes spontaneously \"manifest\" and the eye drifts up of its own accord. Spontaneously manifest DVD can be difficult to control and often causes psychosocial concerns. Traditionally, DVD has been thought to be asymptomatic, although some individuals have double vision. More recently it has been suggested that individuals with DVD may also suffer from eyestrain. Treatment for DVD may be sought either due to psychosocial concerns or because of these symptoms. The standard treatment for DVD is a surgical procedure; non-surgical treatments are offered less commonly. Although there are many studies evaluating different management options for the correction of DVD, a lack of clarity remains regarding which treatments are most effective.\nObjectives\nThe objective of this review was to determine the effectiveness and safety of various surgical and non-surgical interventions in randomized controlled trials of participants with DVD.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), PubMed (1948 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 3 February 2014), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 August 2015.\nSelection criteria\nWe included randomized controlled trials (RCTs) of surgical and non-surgical interventions for the correction of DVD.\nData collection and analysis\nWe used standard procedures expected by Cochrane. Two review authors independently completed eligibility screening, data abstraction, 'Risk of bias' assessment, and grading of the evidence.\nMain results\nWe found four RCTs eligible for inclusion in this review (248 eyes of 151 participants between the ages of 6 months to 22 years). All trials were assessed as having unclear risk of bias overall due to insufficient reporting of study methods. One trial was conducted in Canada and compared anteriorization of the inferior oblique muscle with resection versus anteriorization of the inferior oblique muscle alone; one in the USA compared superior rectus recession with posterior fixation suture versus superior rectus recession alone; and two in the Czech Republic compared anteriorization of the inferior oblique muscle versus myectomy of the inferior oblique muscle.\nOnly one trial reported data that allowed analysis of the primary outcome for this review, the proportion of participants with treatment success. The difference between inferior oblique anteriorization plus resection versus inferior oblique anteriorization alone was uncertain when measured at least four months postoperatively (risk ratio 1.13, 95% confidence interval 0.60 to 2.11, 30 participants, very low-quality evidence). Three trials measured the magnitude of hyperdeviation, but did not provide sufficient data for analysis. All four trials reported a relatively low rate of adverse events; hypotropia, limited elevation, and need for repeat surgery were reported as adverse events associated with some of the surgical interventions. No trials reported any other secondary outcome specified for our review.\nAuthors' conclusions\nThe four trials included in this review assessed the effectiveness of five different surgical procedures for the treatment of DVD. Nevertheless, insufficient reporting of study methods and data led to methodological concerns that undermine the conclusions of all studies. There is a pressing need for carefully executed RCTs of treatment for DVD in order to improve the evidence for the optimal management of this condition.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We conducted the search for studies on 3 August 2015. We found four randomized controlled trials (RCTs) of surgical treatment for DVD. We found no studies evaluating non-surgical treatments. One trial was conducted in Canada and compared a surgical repositioning procedure (anteriorization of the inferior oblique muscle) with or without resection; one in the USA compared surgical weakening of an eye muscle (superior rectus recession) with or without augmentation with a fixation suture; and two in the Czech Republic compared anteriorization of the inferior oblique muscle versus removal of a piece of the inferior oblique muscle (myectomy)."
}
]
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query-laysum | 3078 | [
{
"role": "user",
"content": "Abstract: Background\nOpen fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes.\nObjectives\nTo assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trial registers in February 2021. We also searched conference proceedings and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We aimed to collect data for the following outcomes: limb function, health-related quality of life (HRQoL), deep surgical site infection, delayed or non-union, adverse events (in the short- and long-term course of recovery), and resource-related outcomes.\nMain results\nWe included three RCTs of 613 randomised participants with 617 open fractures. Studies were conducted in medical and trauma centres in the USA and Kenya. Where reported, there was a higher proportion of men and a mean age of participants between 30 and 34 years old. Fractures were in the upper and lower limbs in one study, and were tibia fractures in two studies; where reported, these were the result of high-energy trauma such as road traffic accidents. No studies compared the timing of antibiotic treatment or wound debridement.\nDuration of prophylactic antibiotic treatment (1 study, 77 participants available for analysis)\nOne study compared antibiotic treatment for 24 hours with antibiotic treatment for five days. We are very uncertain about the effects of different durations of antibiotic treatment on superficial infections (risk ratio (RR) 1.19, 95% CI 0.49 to 2.87, favours 5 day treatment; 1 study, 77 participants); this was very low-certainty evidence derived from one small study with unclear and high risks of bias, and with an imprecise effect estimate. This study reported no other review outcomes.\nReconstructive surgery: timing of the stages of surgery (2 studies, 458 participants available for analysis)\nTwo studies compared the timing of wound closure, which was completed immediately or delayed. In one study, the mean time of delay was 5.9 days; in the other study, the time of delay was not reported. We are very uncertain about the effects of different timings of wound closure on deep infections (RR 0.82, 95% CI 0.37 to 1.80, favours immediate closure; 2 studies, 458 participants), delayed union or non-union (RR 1.13, 95% CI 0.83 to 1.55, favours delayed closure; 1 study, 387 participants), or superficial infections (RR 6.45, 95% CI 0.35 to 120.43, favours delayed closure; 1 study, 71 participants); this was very low-certainty evidence. We downgraded the certainty of the evidence for very serious risks of bias because both studies had unclear and high risks of bias. We also downgraded for serious imprecision because effect estimates were imprecise, including the possibility of benefits as well as harms, and very serious imprecision when the data were derived from single small study. These studies reported no other review outcomes.\nAuthors' conclusions\nWe could not determine the risks and benefits of different treatment protocols for open long bone fractures because the evidence was very uncertain for the two comparisons and we did not find any studies addressing the other possible comparisons. Well-designed randomised trials with adequate power are needed to guide surgical and antibiotic treatment of open fractures, particularly with regard to timing and duration of antibiotic administration and timing and staging of surgery.\n\nGiven the provided abstract, please respond to the following query: \"What is an open fracture?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Some broken bones include open skin wounds around the break. These are called open fractures and are most common in high impact injuries such as road traffic accidents or falls from a height. In this review, we were interested in the treatment of open fractures of long bones (in the thigh, shin, lower leg, upper arm and forearms). These fractures can be very serious injuries. Because of the open wound, people are at serious risk of infection. A 'deep infection' involves the bone and will require further surgery; it may be limb-threatening and affect long-term recovery."
}
]
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query-laysum | 3079 | [
{
"role": "user",
"content": "Abstract: Background\nRapid implementation of robotic transabdominal surgery has resulted in the need for re-evaluation of the most suitable form of anaesthesia. The overall objective of anaesthesia is to minimize perioperative risk and discomfort for patients both during and after surgery. Anaesthesia for patients undergoing robotic assisted surgery is different from anaesthesia for patients undergoing open or laparoscopic surgery; new anaesthetic concerns accompany robotic assisted surgery.\nObjectives\nTo assess outcomes related to the choice of total intravenous anaesthesia (TIVA) or inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic gynaecological, urological or gastroenterological surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016 Issue 5), Ovid MEDLINE (1946 to May 2016), Embase via OvidSP (1982 to May 2016), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCOhost (1982 to May 2016) and the Institute for Scientific Information (ISI) Web of Science (1956 to May 2016). We also searched the International Standard Randomized Controlled Trial Number (ISRCTN) Registry and Clinical trials gov for ongoing trials (May 2016).\nSelection criteria\nWe searched for randomized controlled trials (RCTs) including adults, aged 18 years and older, of both genders, treated with transabdominal robotic assisted laparoscopic gynaecological, urological or gastroenterological surgery and focusing on outcomes of TIVA or inhalational anaesthesia.\nData collection and analysis\nWe used standard methodological procedures of Cochrane. Study findings were not suitable for meta-analysis.\nMain results\nWe included three single-centre, two-arm RCTs involving 170 participants. We found one ongoing trial. All included participants were male and were undergoing radical robotic assisted laparoscopic radical prostatectomy (RALRP). The men were between 50 and 75 years of age and met criteria for American Society of Anesthesiologists physical classification scores (ASA) I, ll and III.\nWe found evidence showing no clinically meaningful differences in postoperative pain between the two types of anaesthetics (mean difference (MD) in visual analogue scale (VAS) scores at one to six hours was -2.20 (95% confidence interval (CI) -10.62 to 6.22; P = 0.61) in a sample of 62 participants from one study. Low-quality evidence suggests that propofol reduces postoperative nausea and vomiting (PONV) over the short term (one to six hours after surgery) after RALRP compared with inhalational anaesthesia (sevoflurane, desflurane) (MD -1.70, 95% CI -2.59 to -0.81; P = 0.0002).\nWe found low-quality evidence suggesting that propofol may prevent an increase in intraocular pressure (IOP) after pneumoperitoneum and steep Trendelenburg positioning compared with sevoflurane (MD -3.90, 95% CI -6.34 to -1.46; P = 0.002) with increased IOP from baseline to 30 minutes in steep Trendelenburg. However, it is unclear whether this surrogate outcome translates directly to clinical avoidance of ocular complications during surgery. No studies addressed the secondary outcomes of adverse effects, all-cause mortality, respiratory or circulatory complications, cognitive dysfunction, length of stay or costs. Overall the quality of evidence was low to very low, as all studies were small, single-centre trials providing unclear descriptions of methods.\nAuthors' conclusions\nIt is unclear which anaesthetic technique is superior - TIVA or inhalational - for transabdominal robotic assisted surgery in urology, gynaecology and gastroenterology, as existing evidence is scarce, is of low quality and has been generated from exclusively male patients undergoing robotic radical prostatectomy.\nAn ongoing trial, which includes participants of both genders with a focus on quality of recovery, might have an impact on future evidence related to this topic.\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 May 2016 and was provided by three small randomized controlled trials involving 170 males who had their prostate removed. These studies took place in hospitals in Korea and Turkey. We looked for differences in pain and postoperative nausea and vomiting (PONV) and changes in pressure inside the eyes between patients receiving anaesthetic via the veins or by inhalation."
}
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query-laysum | 3080 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in October 2013 on 'Sumatriptan plus naproxen for acute migraine attacks in adults'.\nMigraine is a common disabling condition and a burden for the individual, health services, and society. It affects two to three times more women than men, and is most common in the age range 30 to 50 years. Effective abortive treatments include the triptan and non-steroidal anti-inflammatory classes of drugs. These drugs have different mechanisms of action and combining them may provide better relief. Sumatriptan plus naproxen is now available in combination form for the acute treatment of migraine.\nObjectives\nTo determine the efficacy and tolerability of sumatriptan plus naproxen, administered together as separate tablets or taken as a fixed-dose combination tablet, compared with placebo and other active interventions in the treatment of acute migraine attacks in adults.\nSearch methods\nFor this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) via The Cochrane Register of Studies Online (CRSO) to 28 October 2015, MEDLINE (via Ovid) from 1946 to 28 October 2015, and EMBASE (via Ovid) from 1974 to 28 October 2015, and two online databases (www.gsk-clinicalstudyregister.com and www.clinicaltrials.gov). We also searched the reference lists of included studies and relevant reviews.\nSelection criteria\nWe included randomised, double-blind, placebo- or active-controlled studies, with at least 10 participants per treatment arm, using sumatriptan plus naproxen to treat a migraine headache episode.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate risk ratio and numbers needed to treat for an additional beneficial outcome (NNT) or for an additional harmful outcome (NNH) compared with placebo or a different active treatment.\nMain results\nFor this update we identified one new study (43 participants), but it did not contribute any data for analysis. The review included 13 studies using sumatriptan 85 mg or 50 mg plus naproxen 500 mg to treat attacks of mild, moderate, or severe pain intensity. Twelve studies contributed data for analyses: 3663 participants received combination treatment, 3682 placebo, 964 sumatriptan, and 982 naproxen. We judged only one small study to be at high risk of bias for any of the criteria evaluated; it did not contribute to any analyses.\nOverall, the combination was better than placebo for the primary outcomes of pain-free and headache relief at two hours. The NNT for pain-free at two hours was 3.1 (95% confidence interval 2.9 to 3.5) when the baseline pain was mild (50% response with sumatriptan plus naproxen compared with 18% with placebo), and 4.9 (4.3 to 5.7) when baseline pain was moderate or severe (28% with sumatriptan plus naproxen compared with 8% with placebo) (high quality evidence). Using 50 mg of sumatriptan, rather than 85 mg, in the combination did not significantly change the result. Treating early, when pain was still mild, was significantly better than treating once pain was moderate or severe for pain-free responses at two hours and during the 24 hours post dose. Adverse events were mostly mild or moderate in severity and rarely led to withdrawal; they were more common with the combination than with placebo (moderate quality evidence).\nWhere the data allowed direct comparison, combination treatment was superior to either monotherapy, but adverse events were less frequent with naproxen than with sumatriptan (moderate quality evidence).\nAuthors' conclusions\nThe conclusions of this review were not changed. Combination treatment was effective in the acute treatment of migraine headaches. The effect was greater than for the same dose of either sumatriptan or naproxen alone, but additional benefits over sumatriptan alone were not large. More participants achieved good relief when medication was taken early in the attack, when pain was still mild. Adverse events were more common with the combination and sumatriptan alone than with placebo or naproxen alone.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The combination of sumatriptan plus naproxen was useful for treating migraine attacks in the studies we found. It was not a lot better than using sumatriptan alone, but it was much better than using naproxen alone. Attacks were more successfully treated when medication was taken early, when pain was mild."
}
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query-laysum | 3081 | [
{
"role": "user",
"content": "Abstract: Background\nThe main focus of treatment for children hospitalised with bronchiolitis is supportive, including oxygen supplementation, respiratory support, and fluid therapy. Up to half of infants hospitalised with bronchiolitis require non-oral fluid therapy due to dehydration or concerns related to the safety of oral feeding. The two main modalities used for non-oral fluid therapy are parenteral (intravenous (IV)) and enteral tube (nasogastric (NG) or orogastric (OG)). However, it is not known which mode is optimal in young children.\nObjectives\nTo systematically review randomised clinical trials (RCTs) of the effectiveness and safety of parenteral and enteral tube fluid therapy for children under two years of age hospitalised with bronchiolitis.\nSearch methods\nWe conducted a search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 March 2021. We handsearched conference proceedings, conducted forward and backward searching of citation lists of relevant articles, and contacted experts.\nSelection criteria\nWe included RCTs and quasi-RCTs of children aged up to two years admitted to hospital with a clinical diagnosis of bronchiolitis who required fluid therapy. The trials compared enteral tube fluid therapy with parenteral fluid therapy. The primary outcome was difference in length of hospital stay in hours after each non-oral fluid therapy modality. As actual time of discharge can be impacted by various factors, we also assessed theoretical length of stay (i.e. time when a patient is safe for discharge). We assessed several secondary outcomes.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThe searches yielded 615 unique records, of which four articles underwent full-text screening. We included two trials (810 children). Oakley 2013 was an open, non-blinded RCT of infants aged two to 12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons. The trial enrolled 759 children, of which 381 were randomised to NG tube therapy and 378 to IV therapy. Risk of bias was low in most domains. Kugelman 2013 was an open, non-blinded RCT that enrolled infants aged less than six months with a clinical diagnosis of \"moderate bronchiolitis\" at a single hospital in Israel. The study enrolled 51 infants, of which 31 were assigned to NG or OG tube therapy and 20 to IV therapy. Risk of bias was unclear in most domains.\nThe application of enteral tube fluid therapy compared to IV fluid therapy probably makes little to no difference for actual length of hospital stay (mean difference (MD) 6.8 hours, 95% confidence interval (CI) −4.7 to 18.4 hours; 2 studies, 810 children, moderate certainty evidence). There was also little to no difference for theoretical length of stay (MD 4.4 hours, 95% CI −3.6 to 12.4 hours; 2 studies, 810 children, moderate certainty evidence). For the secondary outcomes, enteral tube fluid therapy probably makes little to no difference for time to resume full oral feeding compared to IV fluid therapy (MD 2.8 hours, 95% CI −3.6 to 9.2 hours; 2 studies, 810 children, moderate certainty evidence). The use of enteral tube for fluid therapy probably results in a large increase in the success of insertion of fluid modality at first attempt (risk ratio (RR) 1.52, 95% CI 1.36 to 1.69; 1 study, 617 children, moderate certainty evidence), and probably largely reduces the chances of change in fluid therapy modality (RR 0.52, 95% CI 0.38 to 0.71; 1 study, 759 children, moderate certainty evidence) compared to IV fluid.\nOakley 2013 reported 47 local complication events after discharge in the IV fluid group compared to 30 events in the NG tube group. They also evaluated parental satisfaction, which was high with both modalities. Enteral tube fluid therapy makes little to no difference to the duration of oxygen supplementation (MD 2.2 hours, 95% CI -5.0 to 9.5 hours; 2 studies, 810 children, moderate certainty evidence). Compared with the IV fluid therapy group, there was a 17% relative reduction in the number of intensive care unit admissions (RR 0.83, 95% CI 0.47 to 1.46; 1 study, 759 children, moderate certainty evidence) and a 19% relative reduction in number of readmissions to hospital (RR 0.81, 95% CI 0.33 to 2.04; 1 study, 678 children, moderate certainty evidence) in the enteral tube fluid therapy group. Adverse events were uncommon in both trials, with likely little to no differences between groups.\nAuthors' conclusions\nBased on two RCTs, enteral tube feeding likely results in little to no difference in length of hospital stay compared with the IV fluid group. However, enteral tube fluid therapy likely results in a large increase in the success of insertion of fluid modality at first attempt, and a large reduction in change in modality of fluid therapy. It also probably reduces local complications compared to the IV fluid group. Despite bronchiolitis being one of the most prevalent childhood conditions, we identified only two studies with under 1000 participants in total, which highlights the need for multicentre trials. Future studies should explore type of fluid administered, parent-reported outcomes and preferences, and the role of shared decision-making.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is a need for more specific research on this topic, including a better understanding of parent and caregiver preferences related to giving non-oral fluids and how to incorporate shared decision-making, where both patient and doctor work together to make treatment decisions."
}
]
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query-laysum | 3082 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with heart failure report various symptoms and show a trajectory of periodic exacerbations and recoveries, where each exacerbation event may lead to death. Current clinical practice guidelines indicate the importance of discussing future care strategies with people with heart failure. Advance care planning (ACP) is the process of discussing an individual's future care plan according to their values and preferences, and involves the person with heart failure, their family members or surrogate decision-makers, and healthcare providers. Although it is shown that ACP may improve discussion about end-of-life care and documentation of an individual's preferences, the effects of ACP for people with heart failure are uncertain.\nObjectives\nTo assess the effects of advance care planning (ACP) in people with heart failure compared to usual care strategies that do not have any components promoting ACP.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Social Work Abstracts, and two clinical trials registers in October 2019. We checked the reference lists of included studies. There were no restrictions on language or publication status.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared ACP with usual care in people with heart failure. Trials could have parallel group, cluster-randomised, or cross-over designs. We included interventions that implemented ACP, such as discussing and considering values, wishes, life goals, and preferences for future medical care. The study participants comprised adults (18 years of age or older) with heart failure.\nData collection and analysis\nTwo review authors independently extracted outcome data from the included studies, and assessed their risk of bias. We contacted trial authors when we needed to obtain missing information.\nMain results\nWe included nine RCTs (1242 participants and 426 surrogate decision-makers) in this review. The meta-analysis included seven studies (876 participants). Participants' mean ages ranged from 62 to 82 years, and 53% to 100% of the studies' participants were men. All included studies took place in the US or the UK.\nOnly one study reported concordance between participants' preferences and end-of-life care, and it enrolled people with heart failure or renal disease. Owing to one study with small sample size, the effects of ACP on concordance between participants' preferences and end-of-life care were uncertain (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.91 to 1.55; participants = 110; studies = 1; very low-quality evidence). It corresponded to an assumed risk of 625 per 1000 participants receiving usual care and a corresponding risk of 744 per 1000 (95% CI 569 to 969) for ACP. There was no evidence of a difference in quality of life between groups (standardised mean difference (SMD) 0.06, 95% CI –0.26 to 0.38; participants = 156; studies = 3; low-quality evidence). However, one study, which was not included in the meta-analysis, showed that the quality of life score improved by 14.86 points in the ACP group compared with 11.80 points in the usual care group.\nCompletion of documentation by medical staff regarding discussions with participants about ACP processes may have increased (RR 1.68. 95% CI 1.23 to 2.29; participants = 92; studies = 2; low-quality evidence). This corresponded to an assumed risk of 489 per 1000 participants with usual care and a corresponding risk of 822 per 1000 (95% CI 602 to 1000) for ACP. One study, which was not included in the meta-analysis, also showed that ACP helped to improve documentation of the ACP process (hazard ratio (HR) 2.87, 95% CI 1.09 to 7.59; participants = 232).\nThree studies reported that implementation of ACP led to an improvement of participants' depression (SMD –0.58, 95% CI –0.82 to –0.34; participants = 278; studies = 3; low-quality evidence). We were uncertain about the effects of ACP on the quality of communication when compared to the usual care group (MD –0.40, 95% CI –1.61 to 0.81; participants = 9; studies = 1; very low-quality evidence). We also noted an increase in all-cause mortality in the ACP group (RR 1.32, 95% CI 1.04 to 1.67; participants = 795; studies = 5).\nThe studies did not report participants' satisfaction with care/treatment and caregivers' satisfaction with care/treatment.\nAuthors' conclusions\nACP may help to increase documentation by medical staff regarding discussions with participants about ACP processes, and may improve an individual's depression. However, the quality of the evidence about these outcomes was low. The quality of the evidence for each outcome was low to very low due to the small number of studies and participants included in this review. Additionally, the follow-up periods and types of ACP intervention were varied. Therefore, further studies are needed to explore the effects of ACP that consider these differences carefully.\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 investigate how strategies of advance care planning (ACP) affect people with heart failure."
}
]
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query-laysum | 3083 | [
{
"role": "user",
"content": "Abstract: Background\nFollowing cataract surgery and intraocular lens (IOL) implantation, loss of accommodation or postoperative presbyopia occurs and remains a challenge. Standard monofocal IOLs correct only distance vision; patients require spectacles for near vision. Accommodative IOLs have been designed to overcome loss of accommodation after cataract surgery.\nObjectives\nTo define (a) the extent to which accommodative IOLs improve unaided near visual function, in comparison with monofocal IOLs; (b) the extent of compromise to unaided distance visual acuity; c) whether a higher rate of additional complications is associated the use of accommodative IOLs.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 9), Ovid MEDLINE, Ovid MEDLINE in-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily Update, Ovid OLDMEDLINE (January 1946 to October 2013), EMBASE (January 1980 to October 2013), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrial.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 10 October 2013.\nSelection criteria\nWe include randomised controlled trials (RCTs) which compared implantation of accommodative IOLs to implantation of monofocal IOLs in cataract surgery.\nData collection and analysis\nTwo authors independently screened search results, assessed risk of bias and extracted data. All included trials used the 1CU accommodative IOL (HumanOptics, Erlangen, Germany) for their intervention group. One trial had an additional arm with the AT-45 Crystalens accommodative IOL (Eyeonics Vision). We performed a separate analysis comparing 1CU and AT-45 IOL.\nMain results\nWe included four RCTs, including 229 participants (256 eyes), conducted in Germany, Italy and the UK. The age range of participants was 21 to 87 years. All studies included people who had bilateral cataracts with no pre-existing ocular pathologies. We judged all studies to be at high risk of performance bias. We graded two studies with high risk of detection bias and one study with high risk of selection bias.\nParticipants who received the accommodative IOLs achieved better distance-corrected near visual acuity (DCNVA) at six months (mean difference (MD) -3.10 Jaeger units; 95% confidence intervals (CI) -3.36 to -2.83, 2 studies, 106 people, 136 eyes, moderate quality evidence). Better DCNVA was seen in the accommodative lens group at 12 to 18 months in the three trials that reported this time point but considerable heterogeneity of effect was seen, ranging from 1.3 (95% CI 0.98 to 1.68; 20 people, 40 eyes) to 6 (95% CI 4.15 to 7.85; 51 people, 51 eyes) Jaeger units and 0.12 (95% CI 0.05 to 0.19; 40 people, binocular) logMAR improvement (low quality evidence). The relative effect of the lenses on corrected distant visual acuity (CDVA) was less certain. At six months there was a standardised mean difference of -0.04 standard deviations (95% CI -0.37 to 0.30, 2 studies, 106 people, 136 eyes, low quality evidence). At long-term follow-up there was heterogeneity of effect with 18-month data in two studies showing that CDVA was better in the monofocal group (MD 0.12 logMAR; 95% CI 0.07 to 0.16, 2 studies, 70 people,100 eyes) and one study which reported data at 12 months finding similar CDVA in the two groups (-0.02 logMAR units, 95% CI -0.06 to 0.02, 51 people) (low quality evidence).\nThe relative effect of the lenses on reading speed and spectacle independence was uncertain, The average reading speed was 11.6 words per minute more in the accommodative lens group but the 95% confidence intervals ranged from 12.2 words less to 35.4 words more (1 study, 40 people, low quality evidence). People with accommodative lenses were more likely to be spectacle-independent but the estimate was very uncertain (risk ratio (RR) 8.18; 95% CI 0.47 to 142.62, 1 study, 40 people, very low quality evidence).\nMore cases of posterior capsule opacification (PCO) were seen in accommodative lenses but the effect of the lenses on PCO was uncertain (Peto odds ratio (OR) 2.12; 95% CI 0.45 to 10.02, 91 people, 2 studies, low quality evidence). People in the accommodative lens group were more likely to require laser capsulotomy (Peto OR 7.96; 95% CI 2.49 to 25.45, 2 studies, 60 people, 80 eyes, low quality evidence). Glare was reported less frequently with accommodative lenses but the relative effect of the lenses on glare was uncertain (RR any glare 0.78; 95% CI 0.32 to 1.90, 1 study, 40 people, and RR moderate/severe glare 0.45; 95% CI 0.04 to 4.60, low quality evidence).\nAuthors' conclusions\nThere is moderate-quality evidence that study participants who received accommodative IOLs had a small gain in near visual acuity after six months. There is some evidence that distance visual acuity with accommodative lenses may be worse after 12 months but due to low quality of evidence and heterogeneity of effect, the evidence for this is not clear-cut. People receiving accommodative lenses had more PCO which may be associated with poorer distance vision. However, the effect of the lenses on PCO was uncertain.\nFurther research is required to improve the understanding of how accommodative IOLs may affect near visual function, and whether they provide any durable gains. Additional trials, with longer follow-up, comparing different accommodative IOLs, multifocal IOLs and monofocal IOLs, would help map out their relative efficacy, and associated late complications. Research is needed on control over capsular fibrosis postimplantation.\nRisks of bias, heterogeneity of outcome measures and study designs used, and the dominance of one design of accommodative lens in existing trials (the HumanOptics 1CU) mean that these results should be interpreted with caution. They may not be applicable to other accommodative IOL designs.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of the review showed that participants who received accommodative IOLs had improvements in near vision at six months and at 12 months after surgery compared to those who received monofocal IOLs. However, such improvements were small and reduced with time. Low-quality evidence also showed that more than 12 months after surgery, there was a compromise in distance vision for people with accommodative IOLs. This may be related to the finding that those who received accommodative IOLs also appeared to have a higher rate of posterior capsular opacification (thickening and clouding of the tissue behind the IOL). However, these findings were uncertain. Further research on accommodative IOLs is required before we can draw conclusions on their effectiveness and safety compared to monofocal IOLs"
}
]
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query-laysum | 3084 | [
{
"role": "user",
"content": "Abstract: Background\nChildren with autistic spectrum disorder (ASD) frequently present with inattention, impulsivity and hyperactivity, which are the cardinal symptoms of attention deficit hyperactivity disorder (ADHD). The effectiveness of methylphenidate, a commonly used ADHD treatment, is therefore of interest in these children.\nObjectives\nTo assess the effects of methylphenidate for symptoms of ADHD (inattention, impulsivity and hyperactivity) and ASD (impairments in social interaction and communication, and repetitive, restricted or stereotypical behaviours) in children and adolescents aged 6 to 18 years with ASD.\nSearch methods\nIn November 2016, we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 11 other databases and two trials registers. We also checked reference lists and contacted study authors and pharmaceutical companies.\nSelection criteria\nRandomised controlled trials (RCTs) that investigated the effect of methylphenidate versus placebo on the core symptoms of ASD or ADHD-like symptoms, or both, in children aged 6 to 18 years who were diagnosed with ASD or pervasive developmental disorder. The primary outcome was clinical efficacy, defined as an improvement in ADHD-like symptoms (inattention, impulsivity and hyperactivity) and in the core symptoms of ASD (impaired social interaction, impaired communication, and stereotypical behaviours), and overall ASD. Secondary outcomes examined were: rate of adverse events; caregiver well-being; need for institutionalisation, special schooling or therapy to achieve learning outcomes; and overall quality of life.\nData collection and analysis\nWe used standard Cochrane methodological procedures. We combined outcome measures that used different psychometric scales, where clinically appropriate. We used a coefficient of 0.6 to calculate standard deviations and adjust for the studies' cross-over design. We considered a standardised mean difference (SMD) of 0.52 as the minimum clinically relevant inter-treatment difference. We applied the GRADE rating for strength of evidence for each outcome.\nMain results\nThe studies: we included four cross-over studies, with a total of 113 children aged 5 to 13 years, most of whom (83%) were boys. We included two studies with five-year-old children since we were unable to obtain the disaggregated data for those aged six years and above, and all other participants were in our target age range. All participants resided in the USA. The duration of treatment in the cross-over phase was one week for each dose of methylphenidate. Studies used a range of outcome scales, rated by parents, teachers or both; clinicians; or programme staff. We report parent-rated outcomes separately.\nRisk of bias: we considered three trials to be at high risk of bias due to selective reporting and all trials to be at unclear risk of bias for blinding of participants and assessors, due to the potential for recognising the side effects of methylphenidate. We judged all trials to be at low or unclear risk of bias for other items.\nPrimary outcomes: the meta-analysis suggested that high-dose methylphenidate (0.43 mg/kg/dose to 0.60 mg/kg/dose) had a significant and clinically relevant benefit on hyperactivity, as rated by teachers (SMD −0.78, 95% confidence interval (CI) −1.13 to −0.43; 4 studies, 73 participants; P < 0.001; low-quality evidence) and parents (mean difference (MD) −6.61 points, 95% CI −12.19 to −1.03, rated on the hyperactivity subscale of the Aberrant Behviour Checklist, range 0 to 48; 2 studies, 71 participants; P = 0.02; low-quality evidence). Meta-analysis also showed a significant but not clinically relevant benefit on teacher-rated inattention (MD −2.72 points, 95% CI −5.37 to −0.06, rated on the inattention subscale of the Swanson, Nolan and Pelham, Fourth Version questionnaire, range 0 to 27; 2 studies, 51 participants; P = 0.04; low-quality evidence). There were inadequate data to conduct a meta-analysis on the symptom of impulsivity. There was no evidence that methylphenidate worsens the core symptoms of ASD or benefits social interaction (SMD −0.51, 95% CI −1.07 to 0.05; 3 studies, 63 participants; P = 0.07; very low-quality evidence), stereotypical behaviours (SMD −0.34, 95% CI −0.84 to 0.17; 3 studies, 69 participants; P = 0.19; low-quality evidence), or overall ASD (SMD −0.53, 95% CI −1.26 to 0.19; 2 studies, 36 participants; P = 0.15; low-quality evidence), as rated by teachers. There were inadequate data to conduct a meta-analysis on the symptom of impaired communication.\nSecondary outcomes: no data were available for the secondary outcomes of caregiver well-being; need for institutionalisation, special schooling options or therapy to achieve learning outcomes; or overall quality of life. No trials reported serious adverse events. The only adverse effect that was significantly more likely with treatment was reduced appetite as rated by parents (risk ratio 8.28, 95% CI 2.57 to 26.73; 2 studies, 74 participants; P < 0.001; very low-quality evidence). Subgroup analysis by dose did not identify any significant differences in effect on our primary outcomes between low-, medium- or high-dose ranges.\nAuthors' conclusions\nWe found that short-term use of methylphenidate might improve symptoms of hyperactivity and possibly inattention in children with ASD who are tolerant of the medication, although the low quality of evidence means that we cannot be certain of the true magnitude of any effect. There was no evidence that methylphenidate has a negative impact on the core symptoms of ASD, or that it improves social interaction, stereotypical behaviours, or overall ASD. The evidence for adverse events is of very low quality because trials were short and excluded children intolerant of methylphenidate in the test-dose phase. Future RCTs should consider extending the duration of treatment and follow-up. The minimum clinically important difference also needs to be confirmed in children with ASD using outcome scales validated for this population.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to November 2016."
}
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query-laysum | 3085 | [
{
"role": "user",
"content": "Abstract: Background\nHealth insurance has the potential to improve access to health care and protect people from the financial risks of diseases. However, health insurance coverage is often low, particularly for people most in need of protection, including children and other vulnerable populations.\nObjectives\nTo assess the effectiveness of strategies for expanding health insurance coverage in vulnerable populations.\nSearch methods\nWe searched Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library. www.thecochranelibrary.com (searched 2 November 2012), PubMed (searched 1 November 2012), EMBASE (searched 6 July 2012), Global Health (searched 6 July 2012), IBSS (searched 6 July 2012), WHO Library Database (WHOLIS) (searched 1 November 2012), IDEAS (searched 1 November 2012), ISI-Proceedings (searched 1 November 2012),OpenGrey (changed from OpenSIGLE) (searched 1 November 2012), African Index Medicus (searched 1 November 2012), BLDS (searched 1 November 2012), Econlit (searched 1 November 2012), ELDIS (searched 1 November 2012), ERIC (searched 1 November 2012), HERDIN NeON Database (searched 1 November 2012), IndMED (searched 1 November 2012), JSTOR (searched 1 November 2012), LILACS(searched 1 November 2012), NTIS (searched 1 November 2012), PAIS (searched 6 July 2012), Popline (searched 1 November 2012), ProQuest Dissertation &Theses Database (searched 1 November 2012), PsycINFO (searched 6 July 2012), SSRN (searched 1 November 2012), Thai Index Medicus (searched 1 November 2012), World Bank (searched 2 November 2012), WanFang (searched 3 November 2012), China National Knowledge Infrastructure (CHKD-CNKI) (searched 2 November 2012).\nIn addition, we searched the reference lists of included studies and carried out a citation search for the included studies via Web of Science to find other potentially relevant studies.\nSelection criteria\nRandomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies and Interrupted time series (ITS) studies that evaluated the effects of strategies on increasing health insurance coverage for vulnerable populations. We defined strategies as measures to improve the enrolment of vulnerable populations into health insurance schemes. Two categories and six specified strategies were identified as the interventions.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the risk of bias. We undertook a structured synthesis.\nMain results\nWe included two studies, both from the United States. People offered health insurance information and application support by community-based case managers were probably more likely to enrol their children into health insurance programmes (risk ratio (RR) 1.68, 95% confidence interval (CI) 1.44 to 1.96, moderate quality evidence) and were probably more likely to continue insuring their children (RR 2.59, 95% CI 1.95 to 3.44, moderate quality evidence). Of all the children that were insured, those in the intervention group may have been insured quicker (47.3 fewer days, 95% CI 20.6 to 74.0 fewer days, low quality evidence) and parents may have been more satisfied on average (satisfaction score average difference 1.07, 95% CI 0.72 to 1.42, low quality evidence).\nIn the second study applications were handed out in emergency departments at hospitals, compared to not handing out applications, and may have had an effect on enrolment (RR 1.5, 95% CI 1.03 to 2.18, low quality evidence).\nAuthors' conclusions\nCommunity-based case managers who provide health insurance information, application support, and negotiate with the insurer probably increase enrolment of children in health insurance schemes. However, the transferability of this intervention to other populations or other settings is uncertain. Handing out insurance application materials in hospital emergency departments may help increase the enrolment of children in health insurance schemes. Further studies evaluating the effectiveness of different strategies for expanding health insurance coverage in vulnerable population are needed in different settings, with careful attention given to study design.\n\nGiven the provided abstract, please respond to the following query: \"People who are offered health insurance information and application support\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- are probably more likely to enrol their children into health insurance programmes (moderate quality evidence);\n- are probably more likely to continue insuring their children (moderate quality evidence);\n- may be quicker at getting insurance (low quality evidence);\n- may be more satisfied with the process of enrolment (low quality evidence)."
}
]
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query-laysum | 3086 | [
{
"role": "user",
"content": "Abstract: Background\nAs part of efforts to prevent childhood overweight and obesity, we need to understand the relationship between total fat intake and body fatness in generally healthy children.\nObjectives\nTo assess the effects and associations of total fat intake on measures of weight and body fatness in children and young people not aiming to lose weight.\nSearch methods\nFor this update we revised the previous search strategy and ran it over all years in the Cochrane Library, MEDLINE (Ovid), MEDLINE (PubMed), and Embase (Ovid) (current to 23 May 2017). No language and publication status limits were applied. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing and unpublished studies (5 June 2017).\nSelection criteria\nWe included randomised controlled trials (RCTs) in children aged 24 months to 18 years, with or without risk factors for cardiovascular disease, randomised to a lower fat (30% or less of total energy (TE)) versus usual or moderate-fat diet (greater than 30%TE), without the intention to reduce weight, and assessed a measure of weight or body fatness after at least six months. We included prospective cohort studies if they related baseline total fat intake to weight or body fatness at least 12 months later.\nData collection and analysis\nWe extracted data on participants, interventions or exposures, controls and outcomes, and trial or cohort quality characteristics, as well as data on potential effect modifiers, and assessed risk of bias for all included studies. We extracted body weight and blood lipid levels outcomes at six months, six to 12 months, one to two years, two to five years and more than five years for RCTs; and for cohort studies, at baseline to one year, one to two years, two to five years, five to 10 years and more than 10 years. We planned to perform random-effects meta-analyses with relevant subgrouping, and sensitivity and funnel plot analyses where data allowed.\nMain results\nWe included 24 studies comprising three parallel-group RCTs (n = 1054 randomised) and 21 prospective analytical cohort studies (about 25,059 children completed). Twenty-three studies were conducted in high-income countries. No meta-analyses were possible, since only one RCT reported the same outcome at each time point range for all outcomes, and cohort studies were too heterogeneous to combine.\nEffects of dietary counselling to reduce total fat intake from RCTs\nTwo studies recruited children aged between 4 and 11 years and a third recruited children aged 12 to 13 years. Interventions were combinations of individual and group counselling, and education sessions in clinics, schools and homes, delivered by dieticians, nutritionists, behaviourists or trained, supervised teachers. Concerns about imprecision and poor reporting limited our confidence in our findings. In addition, the inclusion of hypercholesteraemic children in two trials raised concerns about applicability.\nOne study of dietary counselling to lower total fat intake found that the intervention may make little or no difference to weight compared with usual diet at 12 months (mean difference (MD) -0.50 kg, 95% confidence interval (CI) -1.78 to 0.78; n = 620; low-quality evidence) and at three years (MD -0.60 kg, 95% CI -2.39 to 1.19; n = 612; low-quality evidence). Education delivered as a classroom curriculum probably decreased BMI in children at 17 months (MD -1.5 kg/m2, 95% CI -2.45 to -0.55; 1 RCT; n = 191; moderate-quality evidence). The effects were smaller at longer term follow-up (five years: MD 0 kg/m2, 95% CI -0.63 to 0.63; n = 541; seven years; MD -0.10 kg/m2, 95% CI -0.75 to 0.55; n = 576; low-quality evidence).\nDietary counselling probably slightly reduced total cholesterol at 12 months compared to controls (MD -0.15 mmol/L, 95% CI -0.24 to -0.06; 1 RCT; n = 618; moderate-quality evidence), but may make little or no difference over longer time periods. Dietary counselling probably slightly decreased low-density lipoprotein (LDL) cholesterol at 12 months (MD -0.12 mmol/L, 95% CI -0.20 to -0.04; 1 RCT; n = 618, moderate-quality evidence) and at five years (MD -0.09, 95% CI -0.17 to -0.01; 1 RCT; n = 623; moderate-quality evidence), compared to controls. Dietary counselling probably made little or no difference to HDL-C at 12 months (MD -0.03 mmol/L, 95% CI -0.08 to 0.02; 1 RCT; n = 618; moderate-quality evidence), and at five years (MD -0.01 mmol/L, 95% CI -0.06 to 0.04; 1 RCT; n = 522; moderate-quality evidence). Likewise, counselling probably made little or no difference to triglycerides in children at 12 months (MD -0.01 mmol/L, 95% CI -0.08 to 0.06; 1 RCT; n = 618; moderate-quality evidence). Lower versus usual or modified fat intake may make little or no difference to height at seven years (MD -0.60 cm, 95% CI -2.06 to 0.86; 1 RCT; n = 577; low-quality evidence).\nAssociations between total fat intake, weight and body fatness from cohort studies\nOver half the cohort analyses that reported on primary outcomes suggested that as total fat intake increases, body fatness measures may move in the same direction. However, heterogeneous methods and reporting across cohort studies, and predominantly very low-quality evidence, made it difficult to draw firm conclusions and true relationships may be substantially different.\nAuthors' conclusions\nWe were unable to reach firm conclusions. Limited evidence from three trials that randomised children to dietary counselling or education to lower total fat intake (30% or less TE) versus usual or modified fat intake, but with no intention to reduce weight, showed small reductions in body mass index, total- and LDL-cholesterol at some time points with lower fat intake compared to controls. There were no consistent effects on weight, high-density lipoprotein (HDL) cholesterol or height. Associations in cohort studies that related total fat intake to later measures of body fatness in children were inconsistent and the quality of this evidence was mostly very low. Most studies were conducted in high-income countries, and may not be applicable in low- and middle-income settings. High-quality, longer-term studies are needed, that include low- and middle-income settings to look at both possible benefits and harms.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What is the relationship between the amount of fat a child eats and their weight and body fat?"
}
]
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query-laysum | 3087 | [
{
"role": "user",
"content": "Abstract: Background\nPlatelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.\nThis is an update of a Cochrane review first published in 2004, and previously updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews looking at these questions individually; this review compares prophylactic platelet transfusion thresholds.\nObjectives\nTo determine whether different platelet transfusion thresholds for administration of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect the efficacy and safety of prophylactic platelet transfusions in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy or haematopoietic stem cell transplantation (HSCT).\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6, 23 July 2015), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015.\nSelection criteria\nWe included RCTs involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with haematological disorders (receiving myelosuppressive chemotherapy or undergoing HSCT) that compared different thresholds for administration of prophylactic platelet transfusions (low trigger (5 x 109/L); standard trigger (10 x 109/L); higher trigger (20 x 109/L, 30 x 109/L, 50 x 109/L); or alternative platelet trigger (for example platelet mass)).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nThree trials met our predefined inclusion criteria and were included for analysis in the review (499 participants). All three trials compared a standard trigger (10 x 109/L) versus a higher trigger (20 x 109/L or 30 x 109/L). None of the trials compared a low trigger versus a standard trigger or an alternative platelet trigger. The trials were conducted between 1991 and 2001 and enrolled participants from fairly comparable patient populations.\nThe original review contained four trials (658 participants); in the previous update of this review we excluded one trial (159 participants) because fewer than 80% of participants had a haematological disorder. We identified no new trials in this update of the review.\nOverall, the methodological quality of the studies was low across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity.\nThree studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no evidence of a difference in the number of participants with a clinically significant bleeding episode between the standard and higher trigger groups (three studies; 499 participants; risk ratio (RR) 1.35, 95% confidence interval (CI) 0.95 to 1.90; low-quality evidence).\nOne study reported the number of days with a clinically significant bleeding event (adjusted for repeated measures). There was no evidence of a difference in the number of days of bleeding per participant between the standard and higher trigger groups (one study; 255 participants; relative proportion of days with World Health Organization Grade 2 or worse bleeding (RR 1.71, 95% CI 0.84 to 3.48, P = 0.162; authors' own results; low-quality evidence).\nTwo studies reported the number of participants with severe or life-threatening bleeding. There was no evidence of any difference in the number of participants with severe or life-threatening bleeding between a standard trigger level and a higher trigger level (two studies; 421 participants; RR 0.99, 95% CI 0.52 to 1.88; low-quality evidence).\nOnly one study reported the time to first bleeding episode. There was no evidence of any difference in the time to the first bleeding episode between a standard trigger level and a higher trigger level (one study; 255 participants; hazard ratio 1.11, 95% CI 0.64 to 1.91; low-quality evidence).\nOnly one study reported on all-cause mortality within 30 days from the start of the study. There was no evidence of any difference in all-cause mortality between standard and higher trigger groups (one study; 255 participants; RR 1.78, 95% CI 0.83 to 3.81; low-quality evidence).\nThree studies reported on the number of platelet transfusions per participant. Two studies reported on the mean number of platelet transfusions per participant. There was a significant reduction in the number of platelet transfusions per participant in the standard trigger group (two studies, mean difference -2.09, 95% CI -3.20 to -0.99; low-quality evidence).\nOne study reported on the number of transfusion reactions. There was no evidence to demonstrate any difference in transfusion reactions between the standard and higher trigger groups (one study; 79 participants; RR 0.07, 95% CI 0.00 to 1.09).\nNone of the studies reported on quality of life.\nAuthors' conclusions\nIn people with haematological disorders who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found low-quality evidence that a standard trigger level (10 x 109/L) is associated with no increase in the risk of bleeding when compared to a higher trigger level (20 x 109/L or 30 x 109/L). There was low-quality evidence that a standard trigger level is associated with a decreased number of transfusion episodes when compared to a higher trigger level (20 x 109/L or 30 x 109/L).\nFindings from this review were based on three studies and 499 participants. Without further evidence, it is reasonable to continue with the current practice of administering prophylactic platelet transfusions using the standard trigger level (10 x 109/L) in the absence of other risk factors for bleeding.\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": "Giving platelet transfusions to people with low platelet counts due to blood cancers or their treatment to prevent bleeding when the platelet count was 10 x 109/L or below did not increase the risk of bleeding compared to giving a platelet transfusion at higher platelet counts (20 x 109/L or below or 30 x 109/L or below).\nGiving platelet transfusions to prevent bleeding only when the platelet count was 10 x 109/L or below resulted in a reduction in the number of platelets given. We found no evidence to demonstrate that giving a platelet transfusion when the platelet count was 10 x 109/L or below decreased the number of transfusion reactions compared to giving platelet transfusions at higher platelet counts (20 x 109/L or below or 30 x 109/L or below).\nNone of the three studies reported any quality of life outcomes.\nFindings from this review were based on three studies and 499 participants. Without further evidence, it is reasonable to continue using platelet transfusions to prevent bleeding based on the current standard transfusion threshold (10 x 109/L)."
}
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query-laysum | 3088 | [
{
"role": "user",
"content": "Abstract: Background\nIncontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD.\nObjectives\nThe objective of this review was to assess the effectiveness of various products and procedures to prevent\nand treat incontinence-associated dermatitis in adults.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field.\nSelection criteria\nWe selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials.\nMain results\nWe included 13 trials with 1316 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.\nEleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.\nNine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.\nWe found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects.\nAuthors' conclusions\nLittle evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.\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 randomised controlled trials which compared skin care products, procedures, methods for using skin care products and frequencies of using a skin care product. The participants had to be over 18 years of age."
}
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query-laysum | 3089 | [
{
"role": "user",
"content": "Abstract: Background\nGout is an inflammatory arthritis resulting from the deposition of monosodium urate crystals in and around joints. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat acute gout. This is an update of a Cochrane Review first published in 2014.\nObjectives\nTo assess the benefits and harms of non-steroidal anti-inflammatory drugs (NSAIDs) (including cyclo-oxygenase-2 (COX-2) inhibitors (COXIBs)) for acute gout.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase for studies to 28 August 2020. We applied no date or language restrictions.\nSelection criteria\nWe considered randomised controlled trials (RCTs) and quasi-RCTs comparing NSAIDs with placebo or another therapy for acute gout. Major outcomes were pain, inflammation, function, participant-reported global assessment, quality of life, withdrawals due to adverse events, and total adverse events.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included in this update 28 trials (3406 participants), including 5 new trials. One trial (30 participants) compared NSAIDs to placebo, 6 (1244 participants) compared non-selective NSAIDs to selective cyclo-oxygenase-2 (COX-2) inhibitors (COXIBs), 5 (712 participants) compared NSAIDs to glucocorticoids, 13 compared one NSAID to another NSAID (633 participants), and single trials compared NSAIDs to rilonacept (225 participants), acupuncture (163 participants), and colchicine (399 participants). Most trials were at risk of selection, performance, and detection biases.\nWe report numerical data for the primary comparison NSAIDs versus placebo and brief results for the two comparisons - NSAIDs versus COX-2 inhibitors and NSAIDs versus glucocorticoids.\nLow-certainty evidence (downgraded for bias and imprecision) from 1 trial (30 participants) shows NSAIDs compared to placebo. More participants (11/15) may have a 50% reduction in pain at 24 hours with NSAIDs than with placebo (4/15) (risk ratio (RR) 2.7, 95% confidence interval (CI) 1.1 to 6.7), with absolute improvement of 47% (3.5% more to 152.5% more). NSAIDs may have little to no effect on inflammation (swelling) after four days (13/15 participants taking NSAIDs versus 12/15 participants taking placebo; RR 1.1, 95% CI 0.8 to 1.5), with absolute improvement of 6.4% (16.8% fewer to 39.2% more). There may be little to no difference in function (4-point scale; 1 = complete resolution) at 24 hours (4/15 participants taking NSAIDs versus 1/15 participants taking placebo; RR 4.0, 95% CI 0.5 to 31.7), with absolute improvement of 20% (3.3% fewer to 204.9% more). NSAIDs may result in little to no difference in withdrawals due to adverse events (0 events in both groups) or in total adverse events; two adverse events (nausea and polyuria) were reported in the placebo group (RR 0.2, 95% CI 0.0, 3.8), with absolute difference of 10.7% more (13.2% fewer to 38% more). Treatment success and health-related quality of life were not measured.\nModerate-certainty evidence (downgraded for bias) from 6 trials (1244 participants) shows non-selective NSAIDs compared to selective COX-2 inhibitors (COXIBs). Non-selective NSAIDs probably result in little to no difference in pain (mean difference (MD) 0.03, 95% CI 0.07 lower to 0.14 higher), swelling (MD 0.08, 95% CI 0.07 lower to 0.22 higher), treatment success (MD 0.08, 95% CI 0.04 lower to 0.2 higher), or quality of life (MD -0.2, 95% CI -6.7 to 6.3) compared to COXIBs. Low-certainty evidence (downgraded for bias and imprecision) suggests no difference in function (MD 0.04, 95% CI -0.17 to 0.25) between groups. Non-selective NSAIDs probably increase withdrawals due to adverse events (RR 2.3, 95% CI 1.3 to 4.1) and total adverse events (mainly gastrointestinal) (RR 1.9, 95% CI 1.4 to 2.8).\nModerate-certainty evidence (downgraded for bias) based on 5 trials (712 participants) shows NSAIDs compared to glucocorticoids. NSAIDs probably result in little to no difference in pain (MD 0.1, 95% CI -2.7 to 3.0), inflammation (MD 0.3, 95% CI 0.07 to 0.6), function (MD -0.2, 95% CI -2.2 to 1.8), or treatment success (RR 0.9, 95% CI 0.7 to 1.2). There was no difference in withdrawals due to adverse events with NSAIDs compared to glucocorticoids (RR 2.8, 95% CI 0.5 to 14.2). There was a decrease in total adverse events with glucocorticoids compared to NSAIDs (RR 1.6, 95% CI 1.0 to 2.5).\nAuthors' conclusions\nLow-certainty evidence from 1 placebo-controlled trial suggests that NSAIDs may improve pain at 24 hours and may have little to no effect on function, inflammation, or adverse events for treatment of acute gout. Moderate-certainty evidence shows that COXIBs and non-selective NSAIDs are probably equally beneficial with regards to improvement in pain, function, inflammation, and treatment success, although non-selective NSAIDs probably increase withdrawals due to adverse events and total adverse events. Moderate-certainty evidence shows that systemic glucocorticoids and NSAIDs probably are equally beneficial in terms of pain relief, improvement in function, and treatment success. Withdrawals due to adverse events were also similar between groups, but NSAIDs probably result in more total adverse events. Low-certainty evidence suggests no difference in inflammation between groups. Only low-certainty evidence was available for the comparisons NSAID versus rilonacept and NSAID versus acupuncture from single trials, or one NSAID versus another NSAID, which also included many NSAIDs that are no longer in clinical use. Although these data were insufficient to support firm conclusions, they do not conflict with clinical guideline recommendations based upon evidence from observational studies, findings for other inflammatory arthritis, and expert consensus, all of which support the use of NSAIDs for acute gout.\n\nGiven the provided abstract, please respond to the following query: \"NSAID versus placebo\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Pain improvement by more than 50% after 24 hours\n47 more people out of 100 who took NSAIDs reported more than 50% improvement in pain compared to those given placebo\n- 73 people out of 100 who took NSAIDs reported more than 50% improvement in pain\n- 26 people out of 100 who took placebo reported more than 50% improvement in pain\nSwelling improvement by more than 50% after 24 hours\n6 more people out of 100 who took NSAIDs had more than 50% improvement in swelling compared to those given placebo\n- 86 people out of 100 who took NSAIDs reported more than 50% improvement in swelling\n- 80 people out of 100 who took placebo reported more than 50% improvement in swelling\nFunction improvement at 24 hours\n20 more people out of 100 who took NSAIDs had improvement in function compared to those given placebo\n- 27 people out of 100 who took NSAIDs reported improvement in function\n- 7 people out of 100 who took placebo reported improvement in function\nSide effects\n10 fewer people out of 100 who took NSAIDs reported side effects compared to those given placebo\n- 3 people out of 100 who took NSAIDs had side effects\n- 13 people out of 100 who took placebo had side effects\nThere were no withdrawals due to side effects."
}
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query-laysum | 3090 | [
{
"role": "user",
"content": "Abstract: Background\nMany women, and other females, with epithelial ovarian cancer (EOC) develop resistance to conventional chemotherapy drugs. Drugs that inhibit angiogenesis (development of new blood vessels), essential for tumour growth, control cancer growth by denying blood supply to tumour nodules.\nObjectives\nTo compare the effectiveness and toxicities of angiogenesis inhibitors for treatment of epithelial ovarian cancer (EOC).\nSearch methods\nWe identified randomised controlled trials (RCTs) by searching CENTRAL, MEDLINE and Embase (from 1990 to 30 September 2022). We searched clinical trials registers and contacted investigators of completed and ongoing trials for further information.\nSelection criteria\nRCTs comparing angiogenesis inhibitors with standard chemotherapy, other types of anti-cancer treatment, other angiogenesis inhibitors with or without other treatments, or placebo/no treatment in a maintenance setting, in women with EOC.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our outcomes were overall survival (OS), progression-free survival (PFS), quality of life (QoL), adverse events (grade 3 and above) and hypertension (grade 2 and above).\nMain results\nWe identified 50 studies (14,836 participants) for inclusion (including five studies from the previous version of this review): 13 solely in females with newly-diagnosed EOC and 37 in females with recurrent EOC (nine studies in platinum-sensitive EOC; 19 in platinum-resistant EOC; nine with studies with mixed or unclear platinum sensitivity). The main results are presented below.\nNewly-diagnosed EOC\nBevacizumab, a monoclonal antibody that binds vascular endothelial growth factor (VEGF), given with chemotherapy and continued as maintenance, likely results in little to no difference in OS compared to chemotherapy alone (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.88 to 1.07; 2 studies, 2776 participants; moderate-certainty evidence). Evidence is very uncertain for PFS (HR 0.82, 95% CI 0.64 to 1.05; 2 studies, 2746 participants; very low-certainty evidence), although the combination results in a slight reduction in global QoL (mean difference (MD) -6.4, 95% CI -8.86 to -3.94; 1 study, 890 participants; high-certainty evidence). The combination likely increases any adverse event (grade ≥ 3) (risk ratio (RR) 1.16, 95% CI 1.07 to 1.26; 1 study, 1485 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 2) (RR 4.27, 95% CI 3.25 to 5.60; 2 studies, 2707 participants; low-certainty evidence).\nTyrosine kinase inhibitors (TKIs) to block VEGF receptors (VEGF-R), given with chemotherapy and continued as maintenance, likely result in little to no difference in OS (HR 0.99, 95% CI 0.84 to 1.17; 2 studies, 1451 participants; moderate-certainty evidence) and likely increase PFS slightly (HR 0.88, 95% CI 0.77 to 1.00; 2 studies, 2466 participants; moderate-certainty evidence). The combination likely reduces QoL slightly (MD -1.86, 95% CI -3.46 to -0.26; 1 study, 1340 participants; moderate-certainty evidence), but it increases any adverse event (grade ≥ 3) slightly (RR 1.31, 95% CI 1.11 to 1.55; 1 study, 188 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 3) (RR 6.49, 95% CI 2.02 to 20.87; 1 study, 1352 participants; low-certainty evidence).\nRecurrent EOC (platinum-sensitive)\nModerate-certainty evidence from three studies (with 1564 participants) indicates that bevacizumab with chemotherapy, and continued as maintenance, likely results in little to no difference in OS (HR 0.90, 95% CI 0.79 to 1.02), but likely improves PFS (HR 0.56, 95% CI 0.50 to 0.63) compared to chemotherapy alone. The combination may result in little to no difference in QoL (MD 0.8, 95% CI -2.11 to 3.71; 1 study, 486 participants; low-certainty evidence), but it increases the rate of any adverse event (grade ≥ 3) slightly (RR 1.11, 1.07 to 1.16; 3 studies, 1538 participants; high-certainty evidence). Hypertension (grade ≥ 3) was more common in arms with bevacizumab (RR 5.82, 95% CI 3.84 to 8.83; 3 studies, 1538 participants).\nTKIs with chemotherapy may result in little to no difference in OS (HR 0.86, 95% CI 0.67 to 1.11; 1 study, 282 participants; low-certainty evidence), likely increase PFS (HR 0.56, 95% CI 0.44 to 0.72; 1 study, 282 participants; moderate-certainty evidence), and may have little to no effect on QoL (MD 6.1, 95% CI -0.96 to 13.16; 1 study, 146 participants; low-certainty evidence). Hypertension (grade ≥ 3) was more common with TKIs (RR 3.32, 95% CI 1.21 to 9.10).\nRecurrent EOC (platinum-resistant)\nBevacizumab with chemotherapy and continued as maintenance increases OS (HR 0.73, 95% CI 0.61 to 0.88; 5 studies, 778 participants; high-certainty evidence) and likely results in a large increase in PFS (HR 0.49, 95% CI 0.42 to 0.58; 5 studies, 778 participants; moderate-certainty evidence). The combination may result in a large increase in hypertension (grade ≥ 2) (RR 3.11, 95% CI 1.83 to 5.27; 2 studies, 436 participants; low-certainty evidence). The rate of bowel fistula/perforation (grade ≥ 2) may be slightly higher with bevacizumab (RR 6.89, 95% CI 0.86 to 55.09; 2 studies, 436 participants).\nEvidence from eight studies suggest TKIs with chemotherapy likely result in little to no difference in OS (HR 0.85, 95% CI 0.68 to 1.08; 940 participants; moderate-certainty evidence), with low-certainty evidence that it may increase PFS (HR 0.70, 95% CI 0.55 to 0.89; 940 participants), and may result in little to no meaningful difference in QoL (MD ranged from -0.19 at 6 weeks to -3.40 at 4 months). The combination increases any adverse event (grade ≥ 3) slightly (RR 1.23, 95% CI 1.02 to 1.49; 3 studies, 402 participants; high-certainty evidence). The effect on bowel fistula/perforation rates is uncertain (RR 2.74, 95% CI 0.77 to 9.75; 5 studies, 557 participants; very low-certainty evidence).\nAuthors' conclusions\nBevacizumab likely improves both OS and PFS in platinum-resistant relapsed EOC. In platinum-sensitive relapsed disease, bevacizumab and TKIs probably improve PFS, but may or may not improve OS. The results for TKIs in platinum-resistant relapsed EOC are similar. The effects on OS or PFS in newly-diagnosed EOC are less certain, with a decrease in QoL and increase in adverse events. Overall adverse events and QoL data were more variably reported than were PFS data.\nThere appears to be a role for anti-angiogenesis treatment, but given the additional treatment burden and economic costs of maintenance treatments, benefits and risks of anti-angiogenesis treatments should be carefully considered.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 50 studies with 14,836 women."
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query-laysum | 3091 | [
{
"role": "user",
"content": "Abstract: Background\nProgesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has been suggested that a causative factor in many cases of miscarriage may be inadequate secretion of progesterone. Therefore, clinicians use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. This is an update of a review, last published in 2013.\nSince publication of the 2018 update of this review, we have been advised that the Ismail 2017 study is currently the subject of an investigation by the Journal of Maternal-Fetal & Neonatal Medicine. We have now moved this study from 'included studies' to 'Characteristics of studies awaiting classification' until the outcome of the investigation is known.\nObjectives\nTo assess the efficacy and safety of progestogens as a preventative therapy against recurrent miscarriage.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2017) and reference lists from relevant articles, attempting to contact trial authors where necessary, and contacted experts in the field for unpublished works.\nSelection criteria\nRandomized or quasi-randomized controlled trials comparing progestogens with placebo or no treatment given in an effort to prevent miscarriage.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the quality of the evidence using the GRADE approach.\nMain results\nTwelve trials (1,856 women) met the inclusion criteria. Eight of the included trials compared treatment with placebo and the remaining four trials compared progestogen administration with no treatment. The trials were a mix of multicenter and single-center trials, conducted in India, Jordan, UK and USA. In five trials women had had three or more consecutive miscarriages and in seven trials women had suffered two or more consecutive miscarriages. Routes, dosage and duration of progestogen treatment varied across the trials. The majority of trials were at low risk of bias for most domains. Ten trials (1684 women) contributed data to the analyses.\nThe meta-analysis of all women, suggests that there may be a reduction in the number of miscarriages for women given progestogen supplementation compared to placebo/controls (average risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 1.00, 10 trials, 1684 women, moderate-quality evidence). A subgroup analysis comparing placebo-controlled versus non-placebo-controlled trials, trials of women with three or more prior miscarriages compared to women with two or more miscarriages and different routes of administration showed no clear differences between subgroups for miscarriage.\nNone of the trials reported on any secondary maternal outcomes, including severity of morning sickness, thromboembolic events, depression, admission to a special care unit, or subsequent fertility.\nThere was probably a slight benefit for women receiving progestogen seen in the outcome of live birth rate (RR 1.07, 95% CI 1.00 to 1.13, 6 trials, 1411 women, moderate-quality evidence). We are uncertain about the effect on the rate of preterm birth because the evidence is very low-quality (RR 1.13, 95% CI 0.53 to 2.41, 4 trials, 256 women, very low-quality evidence). No clear differences were seen for women receiving progestogen for the other secondary outcomes including neonatal death, fetal genital abnormalities or stillbirth. There may be little or no difference in the rate of low birthweight and trials did not report on the secondary child outcomes of teratogenic effects or admission to a special care unit.\nAuthors' conclusions\nFor women with unexplained recurrent miscarriages, supplementation with progestogen therapy may reduce the rate of miscarriage in subsequent pregnancies.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Early pregnancy loss, also known as miscarriage, generally occurs in the first trimester. For some women and their partners, miscarriages can happen several times, also known as recurrent miscarriages. While there are sometimes causes for miscarriages that are found, often no clear reasons can be found. The hormone called progesterone prepares the womb (uterus) to receive and support the newly fertilized egg during the early part of pregnancy. It has been suggested that some women who miscarry may not make enough progesterone in the early part of pregnancy. Supplementing these women with medications that act like progesterone (these are called progestogens) has been suggested as a possible way to prevent recurrent miscarriage.\nSince publication of the 2018 update of this review, we have been advised that one study (by Ismail 2017) is currently the subject of an investigation by the Journal of Maternal-Fetal & Neonatal Medicine. We have now moved this study from 'included studies' to 'Characteristics of studies awaiting classification' until the outcome of the investigation is known."
}
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query-laysum | 3092 | [
{
"role": "user",
"content": "Abstract: Background\nOutcome after acute spontaneous (non-traumatic) intracerebral haemorrhage (ICH) is influenced by haematoma volume. ICH expansion occurs in about 20% of people with acute ICH. Early haemostatic therapy might improve outcome by limiting ICH expansion. This is an update of a Cochrane Review first published in 2006, and last updated in 2018.\nObjectives\nTo examine 1. the effects of individual classes of haemostatic therapies, compared with placebo or open control, in adults with acute spontaneous ICH, and 2. the effects of each class of haemostatic therapy according to the use and type of antithrombotic drug before ICH onset.\nSearch methods\nWe searched the Cochrane Stroke Trials Register, CENTRAL (2022, Issue 8), MEDLINE Ovid, and Embase Ovid on 12 September 2022. To identify further published, ongoing, and unpublished randomised controlled trials (RCTs), we scanned bibliographies of relevant articles and searched international registers of RCTs in September 2022.\nSelection criteria\nWe included RCTs of any haemostatic intervention (i.e. procoagulant treatments such as clotting factor concentrates, antifibrinolytic drugs, platelet transfusion, or agents to reverse the action of antithrombotic drugs) for acute spontaneous ICH, compared with placebo, open control, or an active comparator.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was death/dependence (modified Rankin Scale (mRS) 4 to 6) by day 90. Secondary outcomes were ICH expansion on brain imaging after 24 hours, all serious adverse events, thromboembolic adverse events, death from any cause, quality of life, mood, cognitive function, Barthel Index score, and death or dependence measured on the Extended Glasgow Outcome Scale by day 90.\nMain results\nWe included 20 RCTs involving 4652 participants: nine RCTs of recombinant activated factor VII (rFVIIa) versus placebo/open control (1549 participants), eight RCTs of antifibrinolytic drugs versus placebo/open control (2866 participants), one RCT of platelet transfusion versus open control (190 participants), and two RCTs of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) (47 participants). Four (20%) RCTs were at low risk of bias in all criteria.\nFor rFVIIa versus placebo/open control for spontaneous ICH with or without surgery there was little to no difference in death/dependence by day 90 (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.05; 7 RCTs, 1454 participants; low-certainty evidence). We found little to no difference in ICH expansion between groups (RR 0.81, 95% CI 0.56 to 1.16; 4 RCTs, 220 participants; low-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 0.81, 95% CI 0.30 to 2.22; 2 RCTs, 87 participants; very low-certainty evidence; death from any cause: RR 0.78, 95% CI 0.56 to 1.08; 8 RCTs, 1544 participants; moderate-certainty evidence).\nFor antifibrinolytic drugs versus placebo/open control for spontaneous ICH, there was no difference in death/dependence by day 90 (RR 1.00, 95% CI 0.93 to 1.07; 5 RCTs, 2683 participants; high-certainty evidence). We found a slight reduction in ICH expansion with antifibrinolytic drugs for spontaneous ICH compared to placebo/open control (RR 0.86, 95% CI 0.76 to 0.96; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.02, 95% CI 0.75 to 1.39; 4 RCTs, 2599 participants; high-certainty evidence; death from any cause: RR 1.02, 95% CI 0.89 to 1.18; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in quality of life, mood, or cognitive function (quality of life: mean difference (MD) 0, 95% CI -0.03 to 0.03; 2 RCTs, 2349 participants; mood: MD 0.30, 95% CI -1.98 to 2.57; 2 RCTs, 2349 participants; cognitive function: MD -0.37, 95% CI -1.40 to 0.66; 1 RCTs, 2325 participants; all high-certainty evidence).\nPlatelet transfusion likely increases death/dependence by day 90 compared to open control for antiplatelet-associated ICH (RR 1.29, 95% CI 1.04 to 1.61; 1 RCT, 190 participants; moderate-certainty evidence). We found little to no difference in ICH expansion between groups (RR 1.32, 95% CI 0.91 to 1.92; 1 RCT, 153 participants; moderate-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.46, 95% CI 0.98 to 2.16; 1 RCT, 190 participants; death from any cause: RR 1.42, 95% CI 0.88 to 2.28; 1 RCT, 190 participants; both moderate-certainty evidence).\nFor PCC versus FFP for anticoagulant-associated ICH, the evidence was very uncertain about the effect on death/dependence by day 90, ICH expansion, all serious adverse events, and death from any cause between groups (death/dependence by day 90: RR 1.21, 95% CI 0.76 to 1.90; 1 RCT, 37 participants; ICH expansion: RR 0.54, 95% CI 0.23 to 1.22; 1 RCT, 36 participants; all serious adverse events: RR 0.27, 95% CI 0.02 to 3.74; 1 RCT, 5 participants; death from any cause: RR 0.49, 95% CI 0.16 to 1.56; 2 RCTs, 42 participants; all very low-certainty evidence).\nAuthors' conclusions\nIn this updated Cochrane Review including 20 RCTs involving 4652 participants, rFVIIa likely results in little to no difference in reducing death or dependence after spontaneous ICH with or without surgery; antifibrinolytic drugs result in little to no difference in reducing death or dependence after spontaneous ICH, but result in a slight reduction in ICH expansion within 24 hours; platelet transfusion likely increases death or dependence after antiplatelet-associated ICH; and the evidence is very uncertain about the effect of PCC compared to FFP on death or dependence after anticoagulant-associated ICH. Thirteen RCTs are ongoing and are likely to increase the certainty of the estimates of treatment effect.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if haemostatic therapies such as platelet transfusions, antifibrinolytic medicines (mostly tranexamic acid), clotting factor 7, or prothrombin complex concentrate improve the recovery of people with stroke due to intracerebral haemorrhage.\nWe also wanted to find out if haemostatic therapies caused any unwanted effects."
}
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query-laysum | 3093 | [
{
"role": "user",
"content": "Abstract: Background\nNearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents.\nObjectives\nTo assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children.\nSearch methods\nWe searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than -0.25 diopters (D) spherical equivalent myopia.\nData collection and analysis\nWe followed standard Cochrane methods.\nMain results\nWe included 41 studies (6772 participants). Twenty-one studies contributed data to at least one meta-analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias.\nSpectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average -0.15 D (95% confidence interval [CI] -0.29 to 0.00; n = 142; low-certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI -0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low-certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate-certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (-0.06 mm, 95% CI -0.09 to -0.04; n = 896; moderate-certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low-certainty evidence).\nContact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI -0.06 to 0.47; n = 300; low-certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD -0.11 mm, 95% CI -0.14 to -0.08; n = 300; low-certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI -0.05 to 0.10; n = 415; very low-certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low-certainty evidence).\nPharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate-certainty evidence). Axial elongation was less for children treated with atropine (MD -0.35 mm, 95% CI -0.38 to -0.31; n = 502) and pirenzepine (MD -0.13 mm, 95% CI -0.14 to -0.12; n = 326) than for those treated with placebo (moderate-certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low-certainty evidence) but did not report axial length. Systemic 7-methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI -0.09 to 0.24) nor on axial elongation (MD -0.03 mm, 95% CI -0.10 to 0.03) compared with placebo in one study (n = 77; moderate-certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD -0.05 D, 95% CI -0.21 to 0.11; n = 95; low-certainty evidence).\nCombinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate-certainty evidence). One study reported -0.37 mm (95% CI -0.47 to -0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate-certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate-certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate-certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results.\nNo serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate-certainty evidence).\nAuthors' conclusions\nAntimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low-certainty evidence to support RGPCLs and sperical aberration SCLs.\n\nGiven the provided abstract, please respond to the following query: \"What did we study in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "During childhood and adolescence, the eyeballs can grow too long and can develop myopia. Treatments can slow growth of the eye, thereby slowing down the progression of myopia.\nCochrane researchers assessed how certain the evidence was for each review finding, factoring in problems such as the ways studies were done, inclusion of very small studies, and inconsistent findings across studies. They also looked for factors that can make the evidence more certain, including very large effects. They graded each finding as very low, low, moderate, or high certainty."
}
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query-laysum | 3094 | [
{
"role": "user",
"content": "Abstract: Background\nPlantar heel pain, commonly resulting from plantar fasciitis, often results in significant morbidity. Treatment options include nonsteroidal anti-inflammatory drugs (NSAIDs), orthoses, physical therapy, physical agents (e.g. extracorporeal shock wave therapy (ESWT), laser) and invasive procedures including steroid injections.\nObjectives\nTo assess the effects (benefits and harms) of injected corticosteroids for treating plantar heel pain in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (the Cochrane Library), MEDLINE, Embase, CINAHL, clinical trials registries and conference proceedings. Latest search: 27 March 2017.\nSelection criteria\nRandomised and quasi-randomised trials of corticosteroid injections in the treatment of plantar heel pain in adults were eligible for inclusion.\nData collection and analysis\nAt least two review authors independently selected studies, assessed risk of bias and extracted data. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcome measures. We used a fixed-effect model unless heterogeneity was significant, when a random-effects model was considered. We assessed the overall quality of evidence for individual outcomes using the GRADE approach.\nMain results\nWe included a total of 39 studies (36 randomised controlled trials (RCTs) and 3 quasi-RCTs) that involved a total of 2492 adults. Most studies were small (median = 59 participants). Participants' mean ages ranged from 34 years to 59 years. When reported, most participants had heel pain for several months. The trials were usually conducted in outpatient specialty clinics of tertiary care hospitals in 17 countries. Steroid injection was given with a local anaesthetic agent in 34 trials. Follow-up was from one month to over two years. With one exception, trials were assessed at high risk of bias in one or more domains, mostly relating to lack of blinding, including lack of confirmation of allocation concealment. With two exceptions, we rated the available evidence as very low quality, implying in each case that we are 'very uncertain about the estimate'.\nThe 39 trials covered 18 comparisons, with six of the seven trials with three or four groups providing evidence towards two comparisons.\nEight trials (724 participants) compared steroid injection versus placebo or no treatment. Steroid injection may lead to lower heel pain visual analogue scores (VAS) (0 to 100; higher scores = worse pain) in the short-term (< 1 month) (MD -6.38, 95% CI -11.13 to -1.64; 350 participants; 5 studies; I² = 65%; low quality evidence). Based on a minimal clinically significant difference (MCID) of 8 for average heel pain, the 95% CI includes a marginal clinical benefit. This potential benefit was diminished when data were restricted to three placebo-controlled trials. Steroid injection made no difference to average heel pain in the medium-term (1 to 6 months follow-up) (MD -3.47, 95% CI -8.43 to 1.48; 382 participants; 6 studies; I² = 40%; low quality evidence). There was very low quality evidence for no effect on function in the medium-term and for an absence of serious adverse events (219 participants, 4 studies). No studies reported on other adverse events, such as post-injection pain, and on return to previous activity. There was very low quality evidence for fewer treatment failures (defined variously as persistent heel pain at 8 weeks, steroid injection at 12 weeks, and unrelieved pain at 6 months) after steroid injection.\nThe available evidence for other comparisons was rated as very low quality. We are therefore very uncertain of the estimates for the relative effects on people with heel pain of steroids compared with other interventions in:\n1. Tibial nerve block with anaesthetic (2 trials); orthoses (4 trials); oral NSAIDs (2 trials); and intensive physiotherapy (1 trial).\n2. Physical modalities: ESWT (5 trials); laser (2 trials); and radiation therapy (1 trial).\n3. Other invasive procedures: locally injectable NSAID (1 trial); platelet-rich plasma injections (5 trials); autologous blood injections (2 trials); botulinum toxin injections (2 trials); cryopreserved human amniotic membrane injection (1 trial); localised peppering with a needle (1 trial); dry needling (1 trial); and mini scalpel needle release (1 trial).\nWe are also uncertain about the estimates from trials testing different techniques of local steroid injection: ultrasonography-guided versus palpation-guided (5 trials); and scintigraphy-guided versus palpation-guided (1 trial).\nAn exploratory analysis involving pooling data from 21 trials reporting on adverse events revealed two ruptures of plantar fascia (reported in 1 trial) and three injection site infections (reported in 2 trials) in 699 participants allocated to steroid injection study arms. Five trials reported a total of 27 participants with less serious short-term adverse events in the 699 participants allocated steroid injection study arms. Reported treatments were analgesia, ice or both. Given the high risk of selective reporting for these outcomes and imprecision, this evidence was rated at very low quality.\nAuthors' conclusions\nWe found low quality evidence that local steroid injections compared with placebo or no treatment may slightly reduce heel pain up to one month but not subsequently. The available evidence for other outcomes of this comparison was very low quality. Where available, the evidence from comparisons of steroid injections with other interventions used to treat heel pain and of different methods of guiding the injection was also very low quality. Although serious adverse events relating to steroid injection were rare, these were under-reported and a higher risk cannot be ruled out.\nFurther research should focus on establishing the effects (benefits and harms) of injected steroids compared with placebo in typical clinical settings, subsequent to a course of unsuccessful conservative therapy. Ideally, this should be preceded by research, including patient involvement, aimed to obtain consensus on the priority questions for treating plantar heel pain.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The eight studies comparing steroid injection with placebo or no steroid injection control provided evidence on heel pain, function, serious adverse events and treatment failure. No studies reported on time to return to work or other activities or short-term adverse events, such as injection-site pain. Steroid injection may slightly reduce heel pain for up to one month after treatment, but not in the longer term including up to six months. We are very unsure whether steroid injection affects longer-term function or reduces treatment failure. There were no serious adverse events, such as infection, reported by these studies. However, these are known to be rare events and we looked at the evidence from all of the studies in the review. Of the 21 studies that reported on adverse events, two studies reported three infections and two ruptures of heel tissues in relation to steroid injection.\nThe evidence for all reported outcomes, including heel pain, for the other comparisons was always very low quality. This means we are very unsure of the results of these trials."
}
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query-laysum | 3095 | [
{
"role": "user",
"content": "Abstract: Background\nThere are ongoing concerns regarding pharmaceutical opioid-related harms, including overdose and dependence, with an associated increase in treatment demand. People dependent on pharmaceutical opioids appear to differ in important ways from people who use heroin, yet most opioid agonist treatment research has been conducted in people who use heroin.\nObjectives\nTo assess the effects of maintenance opioid agonist pharmacotherapy for the treatment of pharmaceutical opioid dependence.\nSearch methods\nWe updated our searches of the following databases to January 2022: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, MEDLINE, four other databases, and two trial registers. We checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe included RCTs with adults and adolescents examining maintenance opioid agonist treatments that made the following two comparisons.\n1. Full opioid agonists (methadone, morphine, oxycodone, levo-alpha-acetylmethadol (LAAM), or codeine) versus different full opioid agonists or partial opioid agonists (buprenorphine) for maintenance treatment.\n2. Full or partial opioid agonist maintenance versus non-opioid agonist treatments (detoxification, opioid antagonist, or psychological treatment without opioid agonist treatment).\nData collection and analysis\nWe used standard Cochrane methods.\nMain results\nWe identified eight RCTs that met inclusion criteria (709 participants). We found four studies that compared methadone and buprenorphine maintenance treatment, and four studies that compared buprenorphine maintenance to either buprenorphine taper (in addition to psychological treatment) or a non-opioid maintenance treatment comparison.\nWe found low-certainty evidence from three studies of a difference between methadone and buprenorphine in favour of methadone on self-reported opioid use at end of treatment (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.28 to 0.86; 165 participants), and low-certainty evidence from four studies finding a difference in favour of methadone for retention in treatment (RR 1.21, 95% CI 1.02 to 1.43; 379 participants). We found low-certainty evidence from three studies showing no difference between methadone and buprenorphine on substance use measured with urine drug screens at end of treatment (RR 0.81, 95% CI 0.57 to 1.17; 206 participants), and moderate-certainty evidence from one study of no difference in days of self-reported opioid use (mean difference 1.41 days, 95% CI 3.37 lower to 0.55 days higher; 129 participants). There was low-certainty evidence from three studies of no difference between methadone and buprenorphine on adverse events (RR 1.13, 95% CI 0.66 to 1.93; 206 participants).\nWe found low-certainty evidence from four studies favouring maintenance buprenorphine treatment over non-opioid treatments in terms of fewer opioid positive urine drug tests at end of treatment (RR 0.66, 95% CI 0.52 to 0.84; 270 participants), and very low-certainty evidence from four studies finding no difference on self-reported opioid use in the past 30 days at end of treatment (RR 0.63, 95% CI 0.39 to 1.01; 276 participants). There was low-certainty evidence from three studies of no difference in the number of days of unsanctioned opioid use (standardised mean difference (SMD) −0.19, 95% CI −0.47 to 0.09; 205 participants). There was moderate-certainty evidence from four studies favouring buprenorphine maintenance over non-opioid treatments on retention in treatment (RR 3.02, 95% CI 1.73 to 5.27; 333 participants). There was moderate-certainty evidence from three studies of no difference in adverse effects between buprenorphine maintenance and non-opioid treatments (RR 0.50, 95% CI 0.07 to 3.48; 252 participants).\nThe main weaknesses in the quality of the data was the use of open-label study designs, and difference in follow-up rates between treatment arms.\nAuthors' conclusions\nThere is very low- to moderate-certainty evidence supporting the use of maintenance agonist pharmacotherapy for pharmaceutical opioid dependence. Methadone or buprenorphine did not differ on some outcomes, although on the outcomes of retention and self-reported substance use some results favoured methadone. Maintenance treatment with buprenorphine appears more effective than non-opioid treatments.\nDue to the overall very low- to moderate-certainty evidence and small sample sizes, there is the possibility that the further research may change these findings.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review sought to compare different opioid agonist maintenance treatments (i.e. treatments such as methadone or buprenorphine that are given for at least 30 days to help the person to reduce their unsanctioned medicine use) for the treatment of pharmaceutical opioid dependence. We also compared results from maintenance treatment to short-term treatments such as detoxification (removal of the drug from the body) or psychological treatments (e.g. talking therapy, counselling)."
}
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query-laysum | 3096 | [
{
"role": "user",
"content": "Abstract: Background\nEndoscopy has traditionally been taught with novices practicing on real patients under the supervision of experienced endoscopists. Recently, the growing awareness of the need for patient safety has brought simulation training to the forefront. Simulation training can provide trainees with the chance to practice their skills in a learner-centred, risk-free environment. It is important to ensure that skills gained through simulation positively transfer to the clinical environment. This updated review was performed to evaluate the effectiveness of virtual reality (VR) simulation training in gastrointestinal endoscopy.\nObjectives\nTo determine whether virtual reality simulation training can supplement and/or replace early conventional endoscopy training (apprenticeship model) in diagnostic oesophagogastroduodenoscopy, colonoscopy, and/or sigmoidoscopy for health professions trainees with limited or no prior endoscopic experience.\nSearch methods\nWe searched the following health professions, educational, and computer databases until 12 July 2017: the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase, Scopus, Web of Science, BIOSIS Previews, CINAHL, AMED, ERIC, Education Full Text, CBCA Education, ACM Digital Library, IEEE Xplore, Abstracts in New Technology and Engineering, Computer and Information Systems Abstracts, and ProQuest Dissertations and Theses Global. We also searched the grey literature until November 2017.\nSelection criteria\nWe included randomised and quasi-randomised clinical trials comparing VR endoscopy simulation training versus any other method of endoscopy training with outcomes measured on humans in the clinical setting, including conventional patient-based training, training using another form of endoscopy simulation, or no training. We also included trials comparing two different methods of VR training.\nData collection and analysis\nTwo review authors independently assessed the eligibility and methodological quality of trials, and extracted data on the trial characteristics and outcomes. We pooled data for meta-analysis where participant groups were similar, studies assessed the same intervention and comparator, and had similar definitions of outcome measures. We calculated risk ratio for dichotomous outcomes with 95% confidence intervals (CI). We calculated mean difference (MD) and standardised mean difference (SMD) with 95% CI for continuous outcomes when studies reported the same or different outcome measures, respectively. We used GRADE to rate the quality of the evidence.\nMain results\nWe included 18 trials (421 participants; 3817 endoscopic procedures). We judged three trials as at low risk of bias. Ten trials compared VR training with no training, five trials with conventional endoscopy training, one trial with another form of endoscopy simulation training, and two trials compared two different methods of VR training. Due to substantial clinical and methodological heterogeneity across our four comparisons, we did not perform a meta-analysis for several outcomes. We rated the quality of evidence as moderate, low, or very low due to risk of bias, imprecision, and heterogeneity.\nVirtual reality endoscopy simulation training versus no training: There was insufficient evidence to determine the effect on composite score of competency (MD 3.10, 95% CI -0.16 to 6.36; 1 trial, 24 procedures; low-quality evidence). Composite score of competency was based on 5-point Likert scales assessing seven domains: atraumatic technique, colonoscope advancement, use of instrument controls, flow of procedure, use of assistants, knowledge of specific procedure, and overall performance. Scoring range was from 7 to 35, a higher score representing a higher level of competence. Virtual reality training compared to no training likely provides participants with some benefit, as measured by independent procedure completion (RR 1.62, 95% CI 1.15 to 2.26; 6 trials, 815 procedures; moderate-quality evidence). We evaluated overall rating of performance (MD 0.45, 95% CI 0.15 to 0.75; 1 trial, 18 procedures), visualisation of mucosa (MD 0.60, 95% CI 0.20 to 1.00; 1 trial, 55 procedures), performance time (MD -0.20 minutes, 95% CI -0.71 to 0.30; 2 trials, 29 procedures), and patient discomfort (SMD -0.16, 95% CI -0.68 to 0.35; 2 trials, 145 procedures), all with very low-quality evidence. No trials reported procedure-related complications or critical flaws (e.g. bleeding, luminal perforation) (3 trials, 550 procedures; moderate-quality evidence).\nVirtual reality endoscopy simulation training versus conventional patient-based training: One trial reported composite score of competency but did not provide sufficient data for quantitative analysis. Virtual reality training compared to conventional patient-based training resulted in fewer independent procedure completions (RR 0.45, 95% CI 0.27 to 0.74; 2 trials, 174 procedures; low-quality evidence). We evaluated performance time (SMD 0.12, 95% CI -0.55 to 0.80; 2 trials, 34 procedures), overall rating of performance (MD -0.90, 95% CI -4.40 to 2.60; 1 trial, 16 procedures), and visualisation of mucosa (MD 0.0, 95% CI -6.02 to 6.02; 1 trial, 18 procedures), all with very low-quality evidence. Virtual reality training in combination with conventional training appears to be advantageous over VR training alone. No trials reported any procedure-related complications or critical flaws (3 trials, 72 procedures; very low-quality evidence).\nVirtual reality endoscopy simulation training versus another form of endoscopy simulation: Based on one study, there were no differences between groups with respect to composite score of competency, performance time, and visualisation of mucosa. Virtual reality training in combination with another form of endoscopy simulation training did not appear to confer any benefit compared to VR training alone.\nTwo methods of virtual reality training: Based on one study, a structured VR simulation-based training curriculum compared to self regulated learning on a VR simulator appears to provide benefit with respect to a composite score evaluating competency. Based on another study, a progressive-learning curriculum that sequentially increases task difficulty provides benefit with respect to a composite score of competency over the structured VR training curriculum.\nAuthors' conclusions\nVR simulation-based training can be used to supplement early conventional endoscopy training for health professions trainees with limited or no prior endoscopic experience. However, we found insufficient evidence to advise for or against the use of VR simulation-based training as a replacement for early conventional endoscopy training. The quality of the current evidence was low due to inadequate randomisation, allocation concealment, and/or blinding of outcome assessment in several trials. Further trials are needed that are at low risk of bias, utilise outcome measures with strong evidence of validity and reliability, and examine the optimal nature and duration of training.\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": "Compared to no training, virtual reality training appears to provide trainees with an advantage as measured by the ability to complete procedures independently, overall rating of performance, and visualisation of the colon or oesophagus. We found no conclusive evidence that virtual reality training, as compared with traditional patient-based training or another method of endoscopy simulation training, provided benefit, although data were limited. Existing virtual reality simulation curricula can be improved by applying educational theory such as a progressive learning strategy, whereby trainees complete increasingly difficult cases. The results of this review have shown that virtual reality endoscopy training can be used to supplement early traditional endoscopy training for trainees with limited or no endoscopic experience."
}
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query-laysum | 3097 | [
{
"role": "user",
"content": "Abstract: Background\nOxytocin and prostaglandin are hormones responsible for uterine contraction during the third stage of labour. Receptors in the uterine muscles are stimulated by exogenous or endogenous oxytocin leading to uterine contractions. Nipple stimulation or breastfeeding are stimuli that can lead to the secretion of oxytocin and consequent uterine contractions. Consequently, uterine contractions can reduce bleeding during the third stage of labour.\nObjectives\nTo investigate the effects of breastfeeding or nipple stimulation on postpartum haemorrhage (PPH) during the third stage of labour.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 July 2015) and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing breast stimulation, breastfeeding or suckling for PPH in the third stage of labour were selected for this review.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in terms of risk of bias and independently extracted data. Disagreements were resolved by a third review author.\nMain results\nWe included four trials (4608 women), but only two studies contributed data to the review's analyses (n = 4472). The studies contributing data were assessed as of high risk of bias overall. One of these studies was cluster-randomised and conducted in a low-income country and the other study was carried out in a high-income country. All four included studies assessed blood loss in the third stage of labour. Birth attendants estimated blood loss in two trials. The third trial assessed the hematocrit level on the second day postpartum to determine the effect of the bleeding. The fourth study measured PPH ≥ 500 mL.\nNipple stimulation versus no treatment\nOne study (4385 women) compared the effect of suckling versus no treatment. Blood loss was not measured in 114 women (59 in control group and 55 in suckling group). After excluding twin pregnancies, stillbirths and neonatal deaths, the main analyses for this trial were performed on 4227 vaginal deliveries. In terms of maternal death or severe morbidity, one maternal death occurred in the suckling group due to retained placenta (risk ratio (RR) 3.03, 95% confidence interval (CI) 0.12 to 74.26; one study, participants = 4227; very low quality evidence); severe morbidity was not mentioned. Severe PPH (≥ 1000 mL) was not reported in this study.\nThe incidence of PPH (≥ 500 mL) was similar in the suckling and no treatment groups (RR 0.95, 95% CI 0.77 to 1.16; one study, participants = 4227; moderate quality). There were no group differences between nipple stimulation and no treatment regarding blood loss in the third stage of labour (mean difference (MD) 2.00, 95% CI -7.39 to 11.39; one study, participants = 4227; low quality). The rates of retained placenta were similar (RR 1.01, 95% CI 0.14 to 7.16; one study, participants = 4227; very low quality evidence), as were perinatal deaths (RR 1.06, 95% CI 0.57 to 1.98; one study, participants = 4271; low quality), and maternal readmission to hospital (RR 1.01, 95% CI 0.14 to 7.16; one study, participants = 4227; very low quality). We downgraded the evidence for this comparison for risk of bias concerns in the one included trial (inappropriate analyses for cluster design) and for imprecision (wide CIs crossing the line of no difference and, for some outcomes, few events).\nMany maternal secondary outcomes (including side effects) were not reported. Similarly, most neonatal secondary outcomes were not reported.\nNipple stimulation versus oxytocin\nAnother study compared the effect of nipple stimulation (via a breast pump) with oxytocin. Eighty-seven women were recruited but only 85 women were analysed. Severe PPH ≥ 1000 mL and maternal death or severe morbidity were not reported.\nThere was no clear effect of nipple stimulation on blood loss (MD 15.00, 95% CI -24.50 to 54.50; one study, participants = 85; low quality evidence), or on postnatal anaemia compared to the oxytocin group (MD -0.40, 95% CI -2.22 to 1.42; one study, participants = 85; low quality evidence). We downgraded evidence for this comparison due to risk of bias concerns in the one included trial (alternate allocation) and for imprecision (wide CIs crossing the line of no difference and small sample size).\nMany maternal secondary outcomes (including side effects) were not reported, and none of this review's neonatal secondary outcomes were reported.\nAuthors' conclusions\nNone of the included studies reported one of this review's primary outcomes: severe PPH ≥ 1000 mL. Only one study reported on maternal death or severe morbidity. There were limited secondary outcome data for maternal outcomes and very few secondary outcome data for neonatal outcomes.\nThere was no clear differences between nipple stimulation (suckling) versus no treatment in relation to maternal death, the incidence of PPH (≥ 500 mL), blood loss in the third stage of labour, retained placenta, perinatal deaths or maternal readmission to hospital. Whilst these data are based on a single study with a reasonable sample size, the quality of these data are mostly low or very low.\nThere is insufficient evidence to evaluate the effect of nipple stimulation for reducing postpartum haemorrhage during the third stage of labour and more evidence from high-quality studies is needed. Further high-quality studies should recruit adequate sample sizes, assess the impact of nipple stimulation compared to uterotonic agents such as syntometrine and oxytocin, and report on important outcomes such as those listed in this review.\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": "Most maternal deaths in developing countries related to childbirth are due to postpartum bleeding. This is preventable. This review investigated the effects of breastfeeding and nipple stimulation on bleeding during the third stage of labour."
}
]
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query-laysum | 3098 | [
{
"role": "user",
"content": "Abstract: Background\nThere are many commonly employed forms of treatment for shoulder disorders. This review of acupuncture is one in a series of reviews of varying interventions for shoulder disorders including adhesive capsulitis (frozen shoulder), rotator cuff disease and osteoarthritis. Acupuncture to treat musculoskeletal pain is being used increasingly to confer an analgesic effect and to date its use in shoulder disorder has not been evaluated in a systematic review.\nObjectives\nTo determine the efficacy and safety of acupuncture in the treatment of adults with shoulder pain.\nSearch methods\nThe Cochrane Controlled Trials Register, MEDLINE, EMBASE and CINAHL were searched from inception to December 2003, and reference lists from relevant trials were reviewed.\nSelection criteria\nRandomised and quasi-randomised trials, in all languages, of acupuncture compared to placebo or another intervention in adults with shoulder pain. Specific exclusions were duration of shoulder pain less than three weeks, rheumatoid arthritis, polymyalgia rheumatica, cervically referred pain and fracture.\nData collection and analysis\nTwo reviewers independently extracted trial and outcome data. For continuous outcome measures where the standard deviations were not reported it was either calculated from the raw data or converted from the standard error of the mean. If neither of these was reported, authors were contacted. Where results were reported as median and range, the trial was not included in the meta-analysis, but presented in Additional Tables. Effect sizes were calculated and combined in a pooled analysis if the study end-points population and intervention were homogenous. Results are presented separately for rotator cuff disease, adhesive capsulitis, full thickness rotator cuff tear and mixed diagnoses, and, where possible, combined in meta-analysis to indicate effect of acupuncture across all shoulder disorders.\nMain results\nNine trials of varying methodological quality met the inclusion criteria. For all trials there was poor description of interventions. Varying placebos were used in the different trials. Two trials assessed short-term success (post intervention) of acupuncture for rotator cuff disease and could be combined in meta analysis. There was no significant difference in short-term improvement associated with acupuncture when compared to placebo, but due to small sample sizes this may be explained by Type II error. Acupuncture was of benefit over placebo in improving the Constant Murley Score (a measure of shoulder function) at four weeks (WMD 17.3 (7.79, 26.81)). However, by four months, the difference between the acupuncture and placebo groups, whilst still statistically significant, was no longer likely to be clinically significant (WMD 3.53 (0.74, 6.32)). The Constant Murley Score is graded out of 100, hence a change of 3.53 is unlikely to be of substantial benefit. The results of a small pilot study demonstrated some benefit of both traditional and ear acupuncture plus mobilization over mobilization alone. There was no difference in adverse events related to acupuncture when compared to placebo, however this was assessed by only one trial\nAuthors' conclusions\nDue to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to support or refute the use of acupuncture for shoulder pain although there may be short-term benefit with respect to pain and function. There is a need for further well designed clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Does acupuncture work for treating shoulder pain?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To answer this question, scientists found and analyzed 9 research studies. The studies tested over 500 people who had shoulder pain. People had either acupuncture, a placebo (fake therapy), ultrasound, gentle movement or exercises usually for 20-30 minutes, two to three times a week for 3 to 6 weeks. Even though the studies were small and not of the highest quality, this Cochrane review provides the best evidence we have today."
}
]
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query-laysum | 3099 | [
{
"role": "user",
"content": "Abstract: Background\nRandomized controlled trials (RCTs) have yielded conflicting results regarding the ability of beta-blockers to influence perioperative cardiovascular morbidity and mortality. Thus routine prescription of these drugs in unselected patients remains a controversial issue. A previous version of this review assessing the effectiveness of perioperative beta-blockers in cardiac and non-cardiac surgery was last published in 2018. The previous review has now been split into two reviews according to type of surgery. This is an update and assesses the evidence in cardiac surgery only.\nObjectives\nTo assess the effectiveness of perioperatively administered beta-blockers for the prevention of surgery-related mortality and morbidity in adults undergoing cardiac surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Biosis Previews and Conference Proceedings Citation Index-Science on 28 June 2019. We searched clinical trials registers and grey literature, and conducted backward- and forward-citation searching of relevant articles.\nSelection criteria\nWe included RCTs and quasi-randomized studies comparing beta-blockers with a control (placebo or standard care) administered during the perioperative period to adults undergoing cardiac surgery. We excluded studies in which all participants in the standard care control group were given a pharmacological agent that was not given to participants in the intervention group, studies in which all participants in the control group were given a beta-blocker, and studies in which beta-blockers were given with an additional agent (e.g. magnesium). We excluded studies that did not measure or report review outcomes.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We assessed the certainty of evidence with GRADE.\nMain results\nWe included 63 studies with 7768 participants; six studies were quasi-randomized and the remaining were RCTs. All participants were undergoing cardiac surgery, and in most studies, at least some of the participants were previously taking beta-blockers. Types of beta-blockers were: propranolol, metoprolol, sotalol, esmolol, landiolol, acebutolol, timolol, carvedilol, nadolol, and atenolol. In twelve studies, beta-blockers were titrated according to heart rate or blood pressure. Duration of administration varied between studies, as did the time at which drugs were administered; in nine studies this was before surgery, in 20 studies during surgery, and in the remaining studies beta-blockers were started postoperatively. Overall, we found that most studies did not report sufficient details for us to adequately assess risk of bias. In particular, few studies reported methods used to randomize participants to groups. In some studies, participants in the control group were given beta-blockers as rescue therapy during the study period, and all studies in which the control was standard care were at high risk of performance bias because of the open-label study design. No studies were prospectively registered with clinical trials registers, which limited the assessment of reporting bias. We judged 68% studies to be at high risk of bias in at least one domain.\nStudy authors reported few deaths (7 per 1000 in both the intervention and control groups), and we found low-certainty evidence that beta-blockers may make little or no difference to all-cause mortality at 30 days (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.47 to 1.90; 29 studies, 4099 participants). For myocardial infarctions, we found no evidence of a difference in events (RR 1.05, 95% CI 0.72 to 1.52; 25 studies, 3946 participants; low-certainty evidence). Few study authors reported cerebrovascular events, and the evidence was uncertain (RR 1.37, 95% CI 0.51 to 3.67; 5 studies, 1471 participants; very low-certainty evidence). Based on a control risk of 54 per 1000, we found low-certainty evidence that beta-blockers may reduce episodes of ventricular arrhythmias by 32 episodes per 1000 (RR 0.40, 95% CI 0.25 to 0.63; 12 studies, 2296 participants). For atrial fibrillation or flutter, there may be 163 fewer incidences with beta-blockers, based on a control risk of 327 incidences per 1000 (RR 0.50, 95% CI 0.42 to 0.59; 40 studies, 5650 participants; low-certainty evidence). However, the evidence for bradycardia and hypotension was less certain. We found that beta-blockers may make little or no difference to bradycardia (RR 1.63, 95% CI 0.92 to 2.91; 12 studies, 1640 participants; low-certainty evidence), or hypotension (RR 1.84, 95% CI 0.89 to 3.80; 10 studies, 1538 participants; low-certainty evidence).\nWe used GRADE to downgrade the certainty of evidence. Owing to studies at high risk of bias in at least one domain, we downgraded each outcome for study limitations. Based on effect size calculations in the previous review, we found an insufficient number of participants in all outcomes (except atrial fibrillation) and, for some outcomes, we noted a wide confidence interval; therefore, we also downgraded outcomes owing to imprecision. The evidence for atrial fibrillation and length of hospital stay had a moderate level of statistical heterogeneity which we could not explain, and we, therefore, downgraded these outcomes for inconsistency.\nAuthors' conclusions\nWe found no evidence of a difference in early all-cause mortality, myocardial infarction, cerebrovascular events, hypotension and bradycardia. However, there may be a reduction in atrial fibrillation and ventricular arrhythmias when beta-blockers are used. A larger sample size is likely to increase the certainty of this evidence. Four studies awaiting classification may alter the conclusions of this review.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence in this review was mostly low. We found that many studies reported methods that we believed could influence the results. For example, many studies did not use a placebo-control and the doctors might, therefore, have treated people differently in each group. We were unable to explain some of the differences that we found in the data for atrial fibrillation. We also needed to have evidence from a larger number of participants to be very confident in our findings."
}
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query-laysum | 3100 | [
{
"role": "user",
"content": "Abstract: Background\nMany people with severe mental illness (SMI) have siblings. Siblings are often both natural agents to promote service users’ recovery and vulnerable to mental ill health due to the negative impact of psychosis within the family. Despite a wealth of research evidence supporting the effectiveness of psychoeducation for service users with SMI and their family members, in reducing relapse and promoting compliance with treatment, siblings remain relatively invisible in clinical service settings as well as in research studies. If psychoeducational interventions target siblings and improve siblings' knowledge, coping with caring and overall wellbeing, they could potentially provide a cost-effective option for supporting siblings with resulting benefits for service users' outcomes.\nObjectives\nTo assess the effectiveness of psychoeducation compared with usual care or any other intervention in promoting wellbeing and reducing distress of siblings of people affected by SMI.\nThe secondary objective was, if possible, to determine which type of psychoeducation is most effective.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register and screened the reference lists of relevant reports and reviews (12th November 2013). We contacted trial authors for unpublished and specific data on siblings' outcomes.\nSelection criteria\nAll relevant randomised controlled trials focusing on psychoeducational interventions targeting siblings of all ages (on their own or amongst other family members including service users) of individuals with SMI, using any means and formats of delivery, i.e. individual (family), groups, computer-based.\nData collection and analysis\nTwo review authors independently screened the abstracts and extracted data and two other authors independently checked the screening and extraction process. We contacted authors of trials to ascertain siblings' participation in the trials and seek sibling-specific data in those studies where siblings' data were grouped together with other participants' (most commonly other family members'/carers') outcomes. We calculated the risk difference (RD), its 95% confidence interval (CI) on an intention-to-treat basis. We presented continuous data using the mean difference statistic (MD) and 95% CIs. We assessed risk of bias for the included study and rated quality of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE).\nMain results\nWe found 14 studies that included siblings amongst other family members in receipt of psychoeducational interventions. However, we were only able to include one small trial with relevant and available data (n = 9 siblings out of n = 84 family member/carer-participants) comparing psychoeducational intervention with standard care in a community care setting, over a duration of 21 months. There was insufficient evidence to determine the effects of psychoeducational interventions compared with standard care on 'siblings' quality of life' (n = 9, MD score 3.80 95% CI -0.26 to 7.86, low quality of evidence), coping with (family) burden (n = 9, MD -8.80 95% CI -15.22 to -2.34, low quality of evidence). No sibling left the study early by one year (n = 9, RD 0.00 CI -0.34 to 0.34, low quality of evidence). Low quality and insufficient evidence meant we were unable to determine the effects of psychoeducational interventions compared with standard care on service users' global mental state (n = 9, MD -0.60 CI -3.54 to 2.38, low quality of evidence), their frequency of re-hospitalisation (n = 9, MD -0.70 CI -2.46 to 1.06, low quality of evidence) or duration of inpatient stay (n = 9, MD -2.60 CI -6.34 to 1.14, low quality of evidence), whether their siblings received psychoeducation or not. No study data were available to address the other primary outcomes: 'siblings' psychosocial wellbeing', 'siblings' distress' and adverse effects.\nAuthors' conclusions\nMost studies evaluating psychoeducational interventions recruited siblings along with other family members. However, the proportion of siblings in these studies was low and outcomes for siblings were not reported independently from those of other types of family members. Indeed, only data from one study with nine siblings were available for the review. The limited study data we obtained provides no clear good quality evidence to indicate psychoeducation is beneficial for siblings' wellbeing or for clinical outcomes of people affected by SMI. More randomised studies are justified and needed to understand the role of psychoeducation in addressing siblings' needs for information and support.\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": ".\nThis review compares psychoeducation for siblings of people with severe mental illness versus standard care or any other intervention as a means of improving their own wellbeing and quality of life as well as coping with the care-giving for their mentally ill siblings."
}
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query-laysum | 3101 | [
{
"role": "user",
"content": "Abstract: Background\nThe policy several countries is to provide people with a terminal illness the choice of dying at home; this is supported by surveys that indicate that the general public and people with a terminal illness would prefer to receive end-of-life care at home. This is the fifth update of the original review.\nObjectives\nTo determine if providing home-based end-of-life care reduces the likelihood of dying in hospital and what effect this has on patients' symptoms, quality of life, health service costs and caregivers compared with inpatient hospital or hospice care.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE(R), Embase, CINAHL, and clinical trials registries to 18 March 2020. We checked the reference lists of systematic reviews. For included studies, we checked the reference lists and performed a forward search using ISI Web of Science. We handsearched palliative care journals indexed by ISI Web of Science for online first references.\nSelection criteria\nRandomised controlled trials evaluating the effectiveness of home-based end-of-life care with inpatient hospital or hospice care for people aged 18 years and older.\nData collection and analysis\nTwo review authors independently extracted data and assessed study quality. When appropriate, we combined published data for dichotomous outcomes using a fixed-effect Mantel-Haenszel meta-analysis to calculate risk ratios (RR) with 95% confidence intervals (CI). When combining outcome data was not possible, we reported the results from individual studies.\nMain results\nWe included four randomised trials and found no new studies from the search in March 2020. Home-based end-of-life care increased the likelihood of dying at home compared with usual care (RR 1.31, 95% CI 1.12 to 1.52; 2 trials, 539 participants; I2 = 25%; high-certainty evidence). Admission to hospital varied among the trials (range of RR 0.62, 95% CI 0.48 to 0.79, to RR 2.61, 95% CI 1.50 to 4.55). The effect on patient outcomes and control of symptoms was uncertain. Home-based end-of-life care may slightly improve patient satisfaction at one-month follow-up, with little or no difference at six-month follow-up (2 trials; low-certainty evidence). The effect on caregivers (2 trials; very low-certainty evidence), staff (1 trial; very low-certainty evidence) and health service costs was uncertain (2 trials, very low-certainty evidence).\nAuthors' conclusions\nThe evidence included in this review supports the use of home-based end-of-life care programmes for increasing the number of people who will die at home. Research that assesses the impact of home-based end-of-life care on caregivers and admissions to hospital would be a useful addition to the evidence base, and might inform the delivery of these services.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date was this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies up to 18 March 2020."
}
]
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query-laysum | 3102 | [
{
"role": "user",
"content": "Abstract: Background\nDentistry is a profession with a high prevalence of work-related musculoskeletal disorders (WMSD) among practitioners, with symptoms often starting as early in the career as the student phase. Ergonomic interventions in physical, cognitive, and organisational domains have been suggested to prevent their occurrence, but evidence of their effects remains unclear.\nObjectives\nTo assess the effect of ergonomic interventions for the prevention of work-related musculoskeletal disorders among dental care practitioners.\nSearch methods\nWe searched CENTRAL, MEDLINE PubMed, Embase, PsycINFO ProQuest, NIOSHTIC, NIOSHTIC-2, HSELINE, CISDOC (OSH-UPDATE), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP) Search Portal to August 2018, without language or date restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs, in which participants were adults, aged 18 and older, who were engaged in the practice of dentistry. At least 75% of them had to be free from musculoskeletal pain at baseline. We only included studies that measured at least one of our primary outcomes; i.e. physician diagnosed WMSD, self-reported pain, or work functioning.\nData collection and analysis\nThree authors independently screened and selected 20 potentially eligible references from 946 relevant references identified from the search results. Based on the full-text screening, we included two studies, excluded 16 studies, and two are awaiting classification. Four review authors independently extracted data, and two authors assessed the risk of bias. We calculated the mean difference (MD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% confidence intervals for dichotomous outcomes. We assessed the quality of the evidence for each outcome using the GRADE approach.\nMain results\nWe included two RCTs (212 participants), one of which was a cluster-randomised trial. Adjusting for the design effect from clustering, reduced the total sample size to 210. Both studies were carried out in dental clinics and assessed ergonomic interventions in the physical domain, one by evaluating a multi-faceted ergonomic intervention, which consisted of imparting knowledge and training about ergonomics, work station modification, training and surveying ergonomics at the work station, and a regular exercise program; the other by studying the effectiveness of two different types of instrument used for scaling in preventing WMSDs. We were unable to combine the results from the two studies because of the diversity of interventions and outcomes.\nPhysical ergonomic interventions. Based on one study, there is very low-quality evidence that a multi-faceted intervention has no clear effect on dentists' risk of WMSD in the thighs (RR 0.57, 95% CI 0.23 to 1.42; 102 participants), or feet (RR 0.64, 95% CI 0.29 to 1.41; 102 participants) when compared to no intervention over a six-month period. Based on one study, there is low-quality evidence of no clear difference in elbow pain (MD −0.14, 95% CI −0.39 to 0.11; 110 participants), or shoulder pain (MD −0.32, 95% CI −0.75 to 0.11; 110 participants) in participants who used light weight curettes with wider handles or heavier curettes with narrow handles for scaling over a 16-week period.\nCognitive ergonomic interventions. We found no studies evaluating the effectiveness of cognitive ergonomic interventions.\nOrganisational ergonomic interventions. We found no studies evaluating the effectiveness of organisational ergonomic interventions.\nAuthors' conclusions\nThere is very low-quality evidence from one study showing that a multi-faceted intervention has no clear effect on dentists' risk of WMSD in the thighs or feet when compared to no intervention over a six-month period. This was a poorly conducted study with several shortcomings and errors in statistical analysis of data. There is low-quality evidence from one study showing no clear difference in elbow pain or shoulder pain in participants using light weight, wider handled curettes or heavier and narrow handled curettes for scaling over a 16-week period.\nWe did not find any studies evaluating the effectiveness of cognitive ergonomic interventions or organisational ergonomic interventions.\nOur ability to draw definitive conclusions is restricted by the paucity of suitable studies available to us, and the high risk of bias of the studies that are available. This review highlights the need for well-designed, conducted, and reported RCTs, with long-term follow-up that assess prevention strategies for WMSDs among dental care practitioners.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Dental practitioners are highly susceptible to occupational hazards like MSDs, which have been attributed to deteriorating quality of life, burnout, and poor health, which often result in some practitioners quitting the profession. It has been suggested that introducing ergonomic interventions, by making improvements in working style, instruments used, dental office designs, physical activity, work posture, mental stress levels, appointment scheduling, or work environment may help to prevent WMSDs. Our review evaluated the effectiveness of all of these interventions in preventing WMSDs among those who practiced dentistry, be it dentists, dental hygienists, dental auxiliaries, dental nurses, or dental students. We assessed how well these measures prevented the occurrence of new WMSDs, not how they reduced the severity, or how they eliminated WMSDs that already existed. We evaluated the effectiveness of ergonomic interventions on the number of physician-diagnosed WMSDs, self-reported pain, or work ability."
}
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query-laysum | 3103 | [
{
"role": "user",
"content": "Abstract: Background\nUlcerative colitis (UC) is a chronic inflammatory bowel disease. Corticosteroids and 5-aminosalicylates are the most commonly used therapies. However, many patients require immunosuppressive therapy for steroid-refractory and steroid-dependent disease. Methotrexate is a medication that is effective for treating a variety of inflammatory diseases, including Crohn's disease. This review was performed to determine the effectiveness of methotrexate treatment in UC patients. This review is an update of a previously published Cochrane review.\nObjectives\nTo assess the efficacy and safety of methotrexate for induction of remission in patients with UC.\nSearch methods\nMEDLINE, EMBASE, CENTRAL and the Cochrane IBD/FBD group specialized trials register were searched from from inception to June 26, 2014. Study references and review papers were also searched for additional trials. Abstracts from major gastroenterological meetings were searched to identify research published in abstract form only.\nSelection criteria\nRandomized controlled trials comparing methotrexate with placebo or an active comparator in patients with active ulcerative colitis were considered for inclusion.\nData collection and analysis\nTwo authors independently reviewed studies for eligibility, extracted data and assessed study quality using the Cochrane risk of bias tool. The primary outcome measure was the proportion of patients who achieved clinical remission and withdrawal from steroids as defined by the studies and expressed as a percentage of the total number of patients randomized (intention-to-treat analysis). We calculated the risk ratio (RR) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The overall quality of the evidence supporting the primary outcome was assessed using the GRADE criteria.\nMain results\nTwo studies (n = 101 patients) were included in the review. One study (n = 67) compared oral methotrexate 12.5 mg/week) to placebo. The other study (n = 34) compared oral methotrexate (15 mg/week) to 6-mercaptopurine (1.5 mg/kg/day) and 5-aminosalicylic acid (3 g/day). The placebo-controlled study was judged to be at low risk of bias. The other study was judged to be at high risk of bias due to an open-label design. There was no statistically significant difference in clinical remission rates between methotrexate and placebo patients. Forty-seven per cent (14/30) of methotrexate patients achieved clinical remission and complete withdrawal from steroids during the study period compared to 49% (18/37) of placebo patients (RR 0.96, 95% CI 0.58 to 1.59. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was low due to very sparse data (32 events). There were no statistically significant differences in the proportion of patients who achieved clinical remission and withdrawal from steroids in the study comparing oral methotrexate to 6-mercaptopurine and 5-aminosalicylic acid. At 30 weeks, 58% (7/12) of methotrexate patients achieved clinical remission and withdrawal from steroids compared to 79% (11/14) of 6-mercaptopurine patients (RR 0.74, 95% CI 0.43 to 1.29) and 25% of 5-aminosalicylic acid patients (RR 2.33, 95% CI 0.64 to 8.49). GRADE analyses indicated that the overall quality of the evidence was very low due to very sparse data (18 and 9 events respectively) and and high risk of bias. In the placebo-controlled trial two patients (7%) were withdrawn from the methotrexate group due to adverse events (leucopenia, migraine) compared to one patient (3%) who had a rash in the placebo group (RR 2.47, 95% CI 0.23 to 25.91). Adverse events experienced by methotrexate patients in the active comparator study included nausea and dyspepsia, mild alopecia, mild increase in aspartate aminotransferase levels, peritoneal abscess, hypoalbuminemia, severe rash and atypical pneumonia.\nAuthors' conclusions\nAlthough methotrexate was well-tolerated, the studies showed no benefit for methotrexate over placebo or active comparators. The results for efficacy outcomes between methotrexate and placebo, methotrexate and 6-mercaptopurine and methotrexate and 5-aminosalicylic acid were uncertain. Whether a higher dose or parenteral administration would be effective for induction therapy is unknown. At present there is no evidence supporting the use of methotrexate for induction of remission in active ulcerative colitis. A trial in which larger numbers of patients receive a higher dose of oral methotrexate should be considered. Currently there are two large ongoing placebo-controlled trials (METEOR and MERIT-UC) assessing the efficacy and safety of intramuscular or subcutaneous methotrexate in patients with active UC which may help resolve the evidence supporting the use of methotrexate as therapy for active of ulcerative colitis.\n\nGiven the provided abstract, please respond to the following query: \"What is methotrexate?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Methotrexate is a medicine that reduces the body's natural immune responses and may reduce the inflammation associated with ulcerative colitis. When people with ulcerative colitis are experiencing the symptoms of the disease it is said to be ‘active’; periods when the symptoms stop are called ‘remission’."
}
]
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query-laysum | 3104 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral regional anaesthesia techniques are well established for postoperative pain treatment following knee surgery. The adductor canal block (ACB) is a new technique, which can be applied as a single shot or by catheter for continuous regional analgesia.\nObjectives\nTo compare the analgesic efficacy and adverse events of ACB versus other regional analgesic techniques or systemic analgesic treatment for adults undergoing knee surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase, five other databases, and one trial register on 19 September 2018; we checked references, searched citations, and contacted study authors to identify additional studies.\nSelection criteria\nWe included all randomized controlled trials (RCTs) comparing single or continuous ACB versus other regional analgesic techniques or systemic analgesic treatment. Inclusion was independent of the technique used (landmarks, peripheral nerve stimulator, or ultrasound) and the level of training of providers.\nData collection and analysis\nWe used Cochrane’s standard methodological procedures. Our primary outcomes were pain intensity at rest and during movement; rate of accidental falls; and rates of opioid-related adverse events. We used GRADE to assess the quality of evidence for primary outcomes.\nMain results\nWe included 25 RCTs (1688 participants) in this review (23 trials combined within meta-analyses). In 18 studies, participants underwent total knee arthroplasty (TKA), whereas seven trials investigated patients undergoing arthroscopic knee surgery. We identified 11 studies awaiting classification and 11 ongoing studies.\nWe investigated the following comparisons.\nACB versus sham treatment\nWe included eight trials for this comparison. We found no significant differences in postoperative pain intensity at rest (2 hours: standardized mean difference (SMD) -0.56, 95% confidence interval (CI) -1.20 to 0.07, 4 trials, 208 participants, low-quality evidence; 24 hours: SMD -0.49, 95% CI -1.05 to 0.07, 6 trials, 272 participants, low-quality evidence) or during movement (2 hours: SMD -0.59, 95% CI -1.5 to 0.33; 3 trials, 160 participants, very low-quality evidence; 24 hours: SMD 0.03, 95% CI -0.26 to 0.32, 4 trials, 184 participants, low-quality evidence). Furthermore, they noted no evidence of a difference in postoperative nausea between groups (24 hours: risk ratio (RR) 1.91, 95% CI 0.48 to 7.58, 3 trials, 121 participants, low-quality evidence). One trial reported that no accidental falls occurred 24 hours postoperatively (low-quality evidence).\nACB versus femoral nerve block\nWe included 15 RCTs for this comparison. We found no evidence of a difference in postoperative pain intensity at rest (2 hours: SMD -0.74, 95% CI -1.76 to 0.28, 5 trials, 298 participants, low-quality evidence; 24 hours: SMD 0.04, 95% CI -0.09 to 0.18, 12 trials, 868 participants, high-quality evidence) or during movement (2 hours: SMD -0.47, 95% CI -1.86 to 0.93, 2 trials, 88 participants, very low-quality evidence; 24 hours: SMD 0.56, 95% CI -0.00 to 1.12, 9 trials, 576 participants, very low-quality evidence). They noted no evidence of a difference in postoperative nausea (24 hours: RR 1.22, 95% CI 0.42 to 3.54, 2 trials, 138 participants, low-quality evidence) and no evidence that the rate of accidental falls during postoperative care was significantly different between groups (24 hours: RR 0.20, 95% CI 0.04 to 1.15, 3 trials, 172 participants, low-quality evidence).\nAuthors' conclusions\nWe are currently uncertain whether patients treated with ACB suffer from lower pain intensity at rest and during movement, fewer opioid-related adverse events, and fewer accidental falls during postoperative care compared to patients receiving sham treatment. The same holds true for the comparison of ACB versus femoral nerve block focusing on postoperative pain intensity. The overall evidence level was mostly low or very low, so further research might change the conclusion. The 11 studies awaiting classification and the 11 ongoing studies, once assessed, may alter the conclusions of this review.\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": "Postoperative pain following knee surgery continues to be a relevant healthcare problem. Combinations of different analgesics are the best way to treat postoperative pain. One way is to block specific nerves (called regional anaesthesia) that are responsible for pain development. For many years, blocking the femoral nerve, which is responsible for sensation (e.g. pain) and movement of the upper leg, was very important. In recent years, blocking only one specific part of this nerve (called adductor canal block), which does not influence movement of the upper leg, has become more interesting."
}
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query-laysum | 3105 | [
{
"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: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "11th June 2020."
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query-laysum | 3106 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with asthma who come from minority groups often have poorer asthma outcomes, including more acute asthma-related doctor visits for flare-ups. Various programmes used to educate and empower people with asthma have previously been shown to improve certain asthma outcomes (e.g. adherence outcomes, asthma knowledge scores in children and parents, and cost-effectiveness). Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual, and not just the symptoms of the disease. Therefore, questions about whether tailoring asthma education programmes that are culturally specific for people from minority groups are effective at improving asthma-related outcomes, that are feasible and cost-effective need to be answered.\nObjectives\nTo determine whether culture-specific asthma education programmes, in comparison to generic asthma education programmes or usual care, improve asthma-related outcomes in children and adults with asthma who belong to minority groups.\nSearch methods\nWe searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, Embase, review articles and reference lists of relevant articles. The latest search fully incorporated into the review was performed in June 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups with asthma.\nData collection and analysis\nTwo review authors independently selected, extracted and assessed the data for inclusion. We contacted study authors for further information if required.\nMain results\nIn this review update, an additional three studies and 220 participants were added. A total of seven RCTs (two in adults, four in children, one in both children and adults) with 837 participants (aged from one to 63 years) with asthma from ethnic minority groups were eligible for inclusion in this review. The methodological quality of studies ranged from very low to low. For our primary outcome (asthma exacerbations during follow-up), the quality of evidence was low for all outcomes. In adults, use of a culture-specific programme, compared to generic programmes or usual care did not significantly reduce the number of participants from two studies with 294 participants for: exacerbations with one or more exacerbations during follow-up (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.50 to 1.26), hospitalisations over 12 months (OR 0.83, 95% CI 0.31 to 2.22) and exacerbations requiring oral corticosteroids (OR 0.97, 95% CI 0.55 to 1.73). However, use of a culture-specific programme, improved asthma quality of life scores in 280 adults from two studies (mean difference (MD) 0.26, 95% CI 0.17 to 0.36) (although the MD was less then the minimal important difference for the score). In children, use of a culture-specific programme was superior to generic programmes or usual care in reducing severe asthma exacerbations requiring hospitalisation in two studies with 305 children (rate ratio 0.48, 95% CI 0.24 to 0.95), asthma control in one study with 62 children and QoL in three studies with 213 children, but not for the number of exacerbations during follow-up (OR 1.55, 95% CI 0.66 to 3.66) or the number of exacerbations (MD 0.18, 95% CI -0.25 to 0.62) among 100 children from two studies.\nAuthors' conclusions\nThe available evidence showed that culture-specific education programmes for adults and children from minority groups are likely effective in improving asthma-related outcomes. This review was limited by few studies and evidence of very low to low quality. Not all asthma-related outcomes improved with culture-specific programs for both adults and children. Nevertheless, while modified culture-specific education programs are usually more time intensive, the findings of this review suggest using culture-specific asthma education programmes for children and adults from minority groups. However, more robust RCTs are needed to further strengthen the quality of evidence and determine the cost-effectiveness of culture-specific programs.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Seven studies with 837 participants, aged from one to 63 years old were included in this review update. This review was limited by few studies and the quality of evidence was very low to low. In adults, we found that culture-specific programmes did not improve any of our primary outcomes, but were better in improving quality of life (although the mean difference was less that the minimum important difference for the score) (secondary outcome). In children however, when data were combined from studies, culture-specific programmes reduced severe exacerbations requiring hospitalisation (primary outcome), while single studies showed improved asthma control, asthma knowledge and adherence outcomes for our secondary outcomes."
}
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query-laysum | 3108 | [
{
"role": "user",
"content": "Abstract: Background\nBrain tumour surgery usually is carried out with the patient under general anaesthesia. Over past years, both intravenous and inhalational anaesthetic agents have been used, but the superiority of one agent over the other is a topic of ongoing debate. Early and rapid emergence from anaesthesia is desirable for most neurosurgical patients. With the availability of newer intravenous and inhalational anaesthetic agents, all of which have inherent advantages and disadvantages, we remain uncertain as to which technique may result in more rapid early recovery from anaesthesia.\nObjectives\nTo assess the effects of intravenous versus inhalational techniques for rapid emergence from anaesthesia in patients undergoing brain tumour surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 6) in The Cochrane Library, MEDLINE via Ovid SP (1966 to June 2014) and Embase via Ovid SP (1980 to June 2014). We also searched specific websites, such as www.indmed.nic.in, www.cochrane-sadcct.org and www.Clinicaltrials.gov (October 2014). We reran the searches for all databases in March 2016, and when we update the review, we will deal with the two studies of interest found through this search that are awaiting classification.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared the use of intravenous anaesthetic agents such as propofol and thiopentone with inhalational anaesthetic agents such as isoflurane and sevoflurane for maintenance of general anaesthesia during brain tumour surgery. Primary outcomes were emergence from anaesthesia (assessed by time to follow verbal commands, in minutes) and adverse events during emergence, such as haemodynamic changes, agitation, desaturation, muscle weakness, nausea and vomiting, shivering and pain. Secondary outcomes were time to eye opening, recovery from anaesthesia using the Aldrete or Modified Aldrete score (i.e. time to attain score ≥ 9, in minutes), opioid consumption, brain relaxation (as assessed by the surgeon on a 4- or 5-point scale) and complications of anaesthetic techniques, such as intraoperative haemodynamic instability in terms of hypotension or hypertension (mmHg), increased or decreased heart rate (beats/min) and brain swelling.\nData collection and analysis\nWe used standardized methods in conducting the systematic review, as described by the Cochrane Handbook for Systematic Reviews of Interventions. Two review authors independently extracted details of trial methods and outcome data from reports of all trials considered eligible for inclusion. We performed all analyses on an intention-to-treat basis. We used a fixed-effect model when we found no evidence of significant heterogeneity between studies, and a random-effects model when heterogeneity was likely. For assessments of the overall quality of evidence for each outcome that included pooled data from RCTs only, we downgraded the evidence from 'high quality' by one level for serious (or by two levels for very serious) study limitations (risk of bias), indirectness of evidence, serious inconsistency, imprecision of effect or potential publication bias.\nMain results\nWe included 15 RCTs with 1833 participants. We determined that none of the RCTs were of high methodological quality. For our primary outcomes, pooled results from two trials suggest that time to emergence from anaesthesia, that is, time needed to follow verbal commands, was longer with isoflurane than with propofol (mean difference (MD) -3.29 minutes, 95% confidence interval (CI) -5.41 to -1.18, low-quality evidence), and time to emergence from anaesthesia was not different with sevoflurane compared with propofol (MD 0.28 minutes slower with sevoflurane, 95% CI -0.56 to 1.12, four studies, low-quality evidence). Pooled analyses for adverse events suggest lower risk of nausea and vomiting with propofol than with sevoflurane (risk ratio (RR) 0.68, 95% CI 0.51 to 0.91, low-quality evidence) or isoflurane (RR 0.45, 95% CI 0.26 to 0.78) and greater risk of haemodynamic changes with propofol than with sevoflurane (RR 1.85, 95% CI 1.07 to 3.17), but no differences in the risk of shivering or pain. Pooled analyses for brain relaxation suggest lower risk of tense brain with propofol than with isoflurane (RR 0.88, 95% CI 0.67 to 1.17, low-quality evidence), but no difference when propofol is compared with sevoflurane.\nAuthors' conclusions\nThe finding of our review is that the intravenous technique is comparable with the inhalational technique of using sevoflurane to provide early emergence from anaesthesia. Adverse events with both techniques are also comparable. However, we derived evidence of low quality from a limited number of studies. Use of isoflurane delays emergence from anaesthesia. These results should be interpreted with caution. Randomized controlled trials based on uniform and standard methods are needed. Researchers should follow proper methods of randomization and blinding, and trials should be adequately powered.\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": "The evidence is current to June 2014. We included studies with participants from all age groups except neonates (infants less than 28 days old) who received injectable or gas techniques of anaesthesia during surgery for brain tumour. We reran the searches for all databases in March 2016 and found two studies that are awaiting classification. We will deal with them when we update this review."
}
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query-laysum | 3109 | [
{
"role": "user",
"content": "Abstract: Background\nThe increased birth rate of twins during recent decades and the improved prognosis of preterm infants have resulted in the need to explore measures that could optimize their growth and neurodevelopmental outcomes. It has been postulated that co-bedding simulates twins' intrauterine experiences in which co-regulatory behaviors between them are observed. These behaviors are proposed to benefit twins by reducing their stress, which may promote growth and development. However, in practice, uncertainty surrounds the benefit-risk profile of co-bedding.\nObjectives\nWe aimed to assess the effectiveness of co-bedding compared with separate (individual) care for stable preterm twins in the neonatal nursery in promoting growth and neurodevelopment and reducing short- and long-term morbidities, and to determine whether co-bedding is associated with significant adverse effects.\nAs secondary objectives, we sought to evaluate effects of co-bedding via the following subgroup analyses: twin pairs with different weight ranges (very low birth weight [VLBW] < 1500 grams vs non-VLBW), twins with versus without significant growth discordance at birth, preterm versus borderline preterm twins, twins co-bedded in incubator versus cot at study entry, and twins randomized by twin pair versus neonatal unit.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We used keywords and medical subject headings (MeSH) to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (via PubMed), EMBASE (hosted by EBSCOHOST), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and references cited in our short-listed articles, up to February 29, 2016.\nSelection criteria\nWe included randomized controlled trials with randomization by twin pair and/or by neonatal unit. We excluded cross-over studies.\nData collection and analysis\nWe extracted data using standard methods of the CNRG. Two review authors independently assessed the relevance and risk of bias of retrieved records. We contacted the authors of included studies to request important information missing from their published papers. We expressed our results using risk ratios (RRs) and mean differences (MDs) when appropriate, along with 95% confidence intervals (95% CIs). We adjusted the unit of analysis from individual infants to twin pairs by averaging measurements for each twin pair (continuous outcomes) or by counting outcomes as positive if developed by either twin (dichotomous outcomes).\nMain results\nSix studies met the inclusion criteria; however, only five studies provided data for analysis. Four of the six included studies were small and had significant limitations in design. As each study reported outcomes differently, data for most outcomes were effectively contributed by a single study. Study authors reported no differences between co-bedded twins and twins receiving separate care in terms of rate of weight gain (MD 0.20 grams/kg/d, 95% CI -1.60 to 2.00; one study; 18 pairs of twins; evidence of low quality); apnea, bradycardia, and desaturation (A/B/D) episodes (RR 0.85, 95% CI 0.18 to 4.05; one study; 62 pairs of twins; evidence of low quality); episodes in co-regulated states (MD 0.96, 95% CI -3.44 to 5.36; one study; three pairs of twins; evidence of very low quality); suspected or proven infection (RR 0.84, 95% CI 0.30 to 2.31; three studies; 65 pairs of twins; evidence of very low quality); length of hospital stay (MD -4.90 days, 95% CI -35.23 to 25.43; one study; three pairs of twins; evidence of very low quality); and parental satisfaction measured on a scale of 0 to 55 (MD -0.38, 95% CI -4.49 to 3.73; one study; nine pairs of twins; evidence of moderate quality). Although co-bedded twins appeared to have lower pain scores 30 seconds after heel lance on a scale of 0 to 21 (MD -0.96, 95% CI -1.68 to -0.23; two studies; 117 pairs of twins; I2 = 75%; evidence of low quality), they had higher pain scores 90 seconds after the procedure (MD 1.00, 95% CI 0.14 to 1.86; one study; 62 pairs of twins). Substantial heterogeneity in the outcome of infant pain response after heel prick at 30 seconds post procedure and conflicting results at 30 and 90 seconds post procedure precluded clear conclusions.\nAuthors' conclusions\nEvidence on the benefits and harms of co-bedding for stable preterm twins was insufficient to permit recommendations for practice. Future studies must be adequately powered to detect clinically important differences in growth and neurodevelopment. Researchers should assess harms such as infection, along with medication errors and caregiver satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Overall quality of evidence was low because of limitations in study methods, small sample sizes giving rise to imprecise results, and inconsistency in study results. We can make no recommendations for or against co-bedding for stable preterm twins in the neonatal nursery on the basis of evidence gathered in this review. Further research on this topic is needed."
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query-laysum | 3110 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) Model Lists of Essential Medicines lists chlorpromazine as one of its five medicines used in psychotic disorders.\nObjectives\nTo determine chlorpromazine dose response and dose side-effect relationships for schizophrenia and schizophrenia-like psychoses.\nSearch methods\nWe searched the Cochrane Schizophrenia Group’s Study-Based Register of Trials (December 2008; 2 October 2014; 19 December 2016).\nSelection criteria\nAll relevant randomised controlled trials (RCTs) comparing low doses of chlorpromazine (≤ 400 mg/day), medium dose (401 mg/day to 800 mg/day) or higher doses (> 800 mg/day) for people with schizophrenia, and which reported clinical outcomes.\nData collection and analysis\nWe included studies meeting review criteria and providing useable data. Review authors extracted data independently. For dichotomous data, we calculated fixed-effect risk ratios (RR) and their 95% confidence intervals (CIs). For continuous data, we calculated mean differences (MD) and their 95% CIs based on a fixed-effect model. We assessed risk of bias for included studies and graded trial quality using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nAs a result of searches undertaken in 2014, we found one new study and in 2016 more data for already included studies. Five relevant studies with 1132 participants (585 are relevant to this review) are now included. All are hospital-based trials and, despite over 60 years of chlorpromazine use, have durations of less than six months and all are at least at moderate risk of bias. We found only data on low-dose (≤ 400 mg/day) versus medium-dose chlorpromazine (401 mg/day to 800 mg/day) and low-dose versus high-dose chlorpromazine (> 800 mg/day).\nWhen low-dose chlorpromazine (≤ 400 mg/day) was compared to medium-dose chlorpromazine (401 mg/day to 800 mg/day), there was no clear benefit of one dose over the other for both global and mental state outcomes (low-quality and very low-quality evidence). There was also no clear evidence for people in one dosage group being more likely to leave the study early, over the other dosage group (moderate-quality evidence). Similar numbers of participants from each group experienced agitation and restlessness (very low-quality evidence). However, significantly more people in the medium-dose group (401 mg/day to 800 mg/day) experienced extrapyramidal symptoms in the short term (2 RCTS, n = 108, RR 0.47, 95% CI 0.30 to 0.74, moderate-quality evidence). No data for death were available.\nWhen low-dose chlorpromazine (≤ 400 mg/day) was compared to high-dose chlorpromazine (> 800 mg/day), data from one study with 416 patients were available. Clear evidence of a benefit of the high dose was found with regards to global state. The low-dose group had significantly fewer people improving (RR 1.13, 95% CI 1.01 to 1.25, moderate-quality evidence). There was also a marked difference between the number of people leaving the study from each group for any reason, with significantly more people leaving from the high-dose group (RR 0.60, 95% CI 0.40 to 0.89, moderate-quality evidence). More people in the low-dose group had to leave the study due to deterioration in behaviour (RR 2.70, 95% CI 1.34 to 5.44, low-quality evidence). There was clear evidence of a greater risk of people experiencing extrapyramidal symptoms in general in the high-dose group (RR 0.43, 95% CI 0.32 to 0.59, moderate-quality evidence). One death was reported in the high-dose group yet no effect was shown between the two dosage groups (RR 0.33, 95% CI 0.01 to 8.14, moderate-quality evidence). No data for mental state were available.\nAuthors' conclusions\nThe dosage of chlorpromazine has changed drastically over the past 50 years with lower doses now being the preferred of choice. However, this change was gradual and arose not due to trial-based evidence, but due to clinical experience and consensus. Chlorpromazine is one of the most widely used antipsychotic drugs yet appropriate use of lower levels has come about after many years of trial and error with much higher doses. In the absence of high-grade evaluative studies, clinicians have had no alternative but to learn from experience. However, such an approach can lack scientific rigor and does not allow for proper dissemination of information that would assist clinicians find the optimum treatment dosage for their patients. In the future, data for recently released medication should be available from high-quality trials and studies to provide optimum treatment to patients in the shortest amount of time.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Chlorpromazine showed different effects at varying doses. Based on weak evidence, the effects on people’s mental health at low dosage and medium dosage are much the same. However, there are more side effects at medium dose. There is more improvement in people’s mental health at high dose compared to low dose. However, side effects are much more numerous and debilitating at high dose. In the past fifty years, low dose has been the favoured amount to use with patients. This change has come about gradually and is based on everyday experience and consensus rather than hard scientific evidence. Chlorpromazine is low-cost and widely available. Despite its many side effects, chlorpromazine is likely to remain a benchmark or ‘gold standard’ drug and one of the most widely used treatments for schizophrenia worldwide."
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query-laysum | 3111 | [
{
"role": "user",
"content": "Abstract: Background\nRoutine vaginal examinations are undertaken at regular time intervals during labour to assess whether labour is progressing as expected. Unusually slow progress can be due to underlying problems, described as labour dystocia, or can be a normal variation of progress. Evidence suggests that if mother and baby are well, length of labour alone should not be used to decide whether labour is progressing normally. Other methods to assess labour progress include intrapartum ultrasound and monitoring external physical and behavioural cues. Vaginal examinations can be distressing for women, and overdiagnosis of dystocia can result in iatrogenic morbidity due to unnecessary intervention. It is important to establish whether routine vaginal examinations are effective, both as an accurate measure of physiological labour progress and to distinguish true labour dystocia, or whether other methods for assessing labour progress are more effective. This Cochrane Review is an update of a review first published in 2013.\nObjectives\nTo compare the effectiveness, acceptability, and consequences of routine vaginal examinations compared with other methods, or different timings, to assess labour progress at term.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, and conference proceedings) and ClinicalTrials.gov (28 February 2021). We also searched the reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of vaginal examinations compared with other methods of assessing labour progress and studies assessing different timings of vaginal examinations. Quasi-RCTs and cluster-RCTs were eligible for inclusion. We excluded cross-over trials and conference abstracts.\nData collection and analysis\nTwo review authors independently assessed all studies identified by the search for inclusion in the review. Four review authors independently extracted data. Two review authors assessed risk of bias and certainty of the evidence using GRADE.\nMain results\nWe included four studies that randomised a total of 755 women, with data analysed for 744 women and their babies. Interventions used to assess labour progress were routine vaginal examinations, routine ultrasound assessments, routine rectal examinations, routine vaginal examinations at different frequencies, and vaginal examinations as indicated. We were unable to conduct meta-analysis as there was only one study for each comparison.\nAll studies were at high risk of performance bias due to difficulties with blinding. We assessed two studies as high risk of bias and two as low or unclear risk of bias for other domains. The overall certainty of the evidence assessed using GRADE was low or very low.\nRoutine vaginal examinations versus routine ultrasound to assess labour progress (one study, 83 women and babies)\nStudy in Turkey involving multiparous women with spontaneous onset of labour.\nRoutine vaginal examinations may result in a slight increase in pain compared to routine ultrasound (mean difference −1.29, 95% confidence interval (CI) −2.10 to −0.48; one study, 83 women, low certainty evidence) (pain measured using a visual analogue scale (VAS) in reverse: zero indicating 'worst pain', 10 indicating no pain).\nThe study did not assess our other primary outcomes: positive birth experience; augmentation of labour; spontaneous vaginal birth; chorioamnionitis; neonatal infection; admission to neonatal intensive care unit (NICU).\nRoutine vaginal examinations versus routine rectal examinations to assess labour progress (one study, 307 women and babies)\nStudy in Ireland involving women in labour at term. We assessed the certainty of the evidence as very low.\nCompared with routine rectal examinations, routine vaginal examinations may have little or no effect on: augmentation of labour (risk ratio (RR) 1.03, 95% CI 0.63 to 1.68; one study, 307 women); and spontaneous vaginal birth (RR 0.98, 95% CI 0.90 to 1.06; one study, 307 women).\nWe found insufficient data to fully assess: neonatal infections (RR 0.33, 95% CI 0.01 to 8.07; one study, 307 babies); and admission to NICU (RR 1.32, 95% CI 0.47 to 3.73; one study, 307 babies).\nThe study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; maternal pain.\nRoutine four-hourly vaginal examinations versus routine two-hourly examinations (one study, 150 women and babies)\nUK study involving primiparous women in labour at term. We assessed the certainty of the evidence as very low.\nCompared with routine two-hourly vaginal examinations, routine four-hourly vaginal examinations may have little or no effect, with data compatible with both benefit and harm, on: augmentation of labour (RR 0.97, 95% CI 0.60 to 1.57; one study, 109 women); and spontaneous vaginal birth (RR 1.02, 95% CI 0.83 to 1.26; one study, 150 women).\nThe study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; neonatal infection; admission to NICU; maternal pain.\nRoutine vaginal examinations versus vaginal examinations as indicated (one study, 204 women and babies)\nStudy in Malaysia involving primiparous women being induced at term. We assessed the certainty of the evidence as low.\nCompared with vaginal examinations as indicated, routine four-hourly vaginal examinations may result in more women having their labour augmented (RR 2.55, 95% CI 1.03 to 6.31; one study, 204 women).\nThere may be little or no effect on:\n• spontaneous vaginal birth (RR 1.08, 95% CI 0.73 to 1.59; one study, 204 women);\n• chorioamnionitis (RR 3.06, 95% CI 0.13 to 74.21; one study, 204 women);\n• neonatal infection (RR 4.08, 95% CI 0.46 to 35.87; one study, 204 babies);\n• admission to NICU (RR 2.04, 95% CI 0.63 to 6.56; one study, 204 babies).\nThe study did not assess our other primary outcomes of positive birth experience or maternal pain.\nAuthors' conclusions\nBased on these findings, we cannot be certain which method is most effective or acceptable for assessing labour progress. Further large-scale RCT trials are required. These should include essential clinical and experiential outcomes. This may be facilitated through the development of a tool to measure positive birth experiences. Data from qualitative studies are also needed to fully assess whether methods to evaluate labour progress meet women's needs for a safe and positive labour and birth, and if not, to develop an approach that does.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Labour is usually monitored to ensure that it is progressing as expected, and that there are no signs of abnormal progress that might be harmful to mother or baby. The method most commonly used is routine vaginal examination (undertaken at regular time intervals), which provides information on how dilated the woman's cervix is and the position of the baby. Very slow labours can be a sign of underlying problems that may require interventions to speed up labour and birth (augmentation). However, slow labours can also be a normal variation of labour progress, and recent evidence suggests that if mother and baby are well, length of labour or cervical dilation alone should not be used to decide whether labour is progressing normally.\nOther methods to assess labour progress include the use of ultrasound, assessing how the mother behaves, and external physical signs of progress, such as a purple line that develops between the mother's buttocks as labour progresses. However, these methods are not standard practice. The most effective method to assess labour progress has not been established.\nVaginal examinations can be uncomfortable, painful, and distressing. If slow but normal labours are misdiagnosed as being abnormal, this can lead to unnecessary interventions, such as augmentation or caesarean section. Some women may not want these interventions, and their use can cause emotional and physical harm. Misdiagnosis of labour progress either way can be physically and emotionally devastating. Women's views and experiences of the methods used to assess labour progress should be considered, alongside evidence of effectiveness."
}
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query-laysum | 3112 | [
{
"role": "user",
"content": "Abstract: Background\nDifferent bone-modifying agents like bisphosphonates and receptor activator of nuclear factor-kappa B ligand (RANKL)-inhibitors are used as supportive treatment in men with prostate cancer and bone metastases to prevent skeletal-related events (SREs). SREs such as pathologic fractures, spinal cord compression, surgery and radiotherapy to the bone, and hypercalcemia lead to morbidity, a poor performance status, and impaired quality of life. Efficacy and acceptability of the bone-targeted therapy is therefore of high relevance. Until now recommendations in guidelines on which bone-modifying agents should be used are rare and inconsistent.\nObjectives\nTo assess the effects of bisphosphonates and RANKL-inhibitors as supportive treatment for prostate cancer patients with bone metastases and to generate a clinically meaningful treatment ranking according to their safety and efficacy using network meta-analysis.\nSearch methods\nWe identified studies by electronically searching the bibliographic databases Cochrane Controlled Register of Trials (CENTRAL), MEDLINE, and Embase until 23 March 2020. We searched the Cochrane Library and various trial registries and screened abstracts of conference proceedings and reference lists of identified trials.\nSelection criteria\nWe included randomized controlled trials comparing different bisphosphonates and RANKL-inihibitors with each other or against no further treatment or placebo for men with prostate cancer and bone metastases. We included men with castration-restrictive and castration-sensitive prostate cancer and conducted subgroup analyses according to this criteria.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of trials. We defined proportion of participants with pain response and the adverse events renal impairment and osteonecrosis of the jaw (ONJ) as the primary outcomes. Secondary outcomes were SREs in total and each separately (see above), mortality, quality of life, and further adverse events such as grade 3 to 4 adverse events, hypocalcemia, fatigue, diarrhea, and nausea. We conducted network meta-analysis and generated treatment rankings for all outcomes, except quality of life due to insufficient reporting on this outcome. We compiled ranking plots to compare single outcomes of efficacy against outcomes of acceptability of the bone-modifying agents. We assessed the certainty of the evidence for the main outcomes using the GRADE approach.\nMain results\nTwenty-five trials fulfilled our inclusion criteria. Twenty-one trials could be considered in the quantitative analysis, of which six bisphosphonates (zoledronic acid, risedronate, pamidronate, alendronate, etidronate, or clodronate) were compared with each other, the RANKL-inhibitor denosumab, or no treatment/placebo. By conducting network meta-analysis we were able to compare all of these reported agents directly and/or indirectly within the network for each outcome. In the abstract only the comparisons of zoledronic acid and denosumab against the main comparator (no treatment/placebo) are described for outcomes that were predefined as most relevant and that also appear in the 'Summary of findings' table. Other results, as well as results of subgroup analyses regarding castration status of participants, are displayed in the Results section of the full text.\nTreatment with zoledronic acid probably neither reduces nor increases the proportion of participants with pain response when compared to no treatment/placebo (risk ratio (RR) 1.46, 95% confidence interval (CI) 0.93 to 2.32; per 1000 participants 121 more (19 less to 349 more); moderate-certainty evidence; network based on 4 trials including 1013 participants). For this outcome none of the trials reported results for the comparison with denosumab.\nThe adverse event renal impairment probably occurs more often when treated with zoledronic acid compared to no treatment/placebo (RR 1.63, 95% CI 1.08 to 2.45; per 1000 participants 78 more (10 more to 180 more); moderate-certainty evidence; network based on 6 trials including 1769 participants). Results for denosumab could not be included for this outcome, since zero events cannot be considered in the network meta-analysis, therefore it does not appear in the ranking.\nTreatment with denosumab results in increased occurrence of the adverse event ONJ (RR 3.45, 95% CI 1.06 to 11.24; per 1000 participants 30 more (1 more to 125 more); high-certainty evidence; 4 trials, 3006 participants) compared to no treatment/placebo. When comparing zoledronic acid to no treatment/placebo, the confidence intervals include the possibility of benefit or harm, therefore treatment with zoledronic acid probably neither reduces nor increases ONJ (RR 1.88, 95% CI 0.73 to 4.87; per 1000 participants 11 more (3 less to 47 more); moderate-certainty evidence; network based on 4 trials including 3006 participants).\nCompared to no treatment/placebo, treatment with zoledronic acid (RR 0.84, 95% CI 0.72 to 0.97) and denosumab (RR 0.72, 95% CI 0.54 to 0.96) may result in a reduction of the total number of SREs (per 1000 participants 75 fewer (131 fewer to 14 fewer) and 131 fewer (215 fewer to 19 fewer); both low-certainty evidence; 12 trials, 5240 participants).\nTreatment with zoledronic acid and denosumab likely neither reduces nor increases mortality when compared to no treatment/placebo (zoledronic acid RR 0.90, 95% CI 0.80 to 1.01; per 1000 participants 48 fewer (97 fewer to 5 more); denosumab RR 0.93, 95% CI 0.77 to 1.11; per 1000 participants 34 fewer (111 fewer to 54 more); both moderate-certainty evidence; 13 trials, 5494 participants).\nDue to insufficient reporting, no network meta-analysis was possible for the outcome quality of life. One study with 1904 participants comparing zoledronic acid and denosumab showed that more zoledronic acid-treated participants than denosumab-treated participants experienced a greater than or equal to five-point decrease in Functional Assessment of Cancer Therapy-General total scores over a range of 18 months (average relative difference = 6.8%, range −9.4% to 14.6%) or worsening of cancer-related quality of life.\nAuthors' conclusions\nWhen considering bone-modifying agents as supportive treatment, one has to balance between efficacy and acceptability. Results suggest that Zoledronic acid likely increases both the proportion of participants with pain response, and the proportion of participants experiencing adverse events However, more trials with head-to-head comparisons including all potential agents are needed to draw the whole picture and proof the results of this analysis.\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": "In this systematic review we aimed to compare different agents to prevent skeletal complications in men with prostate cancer and bone metastases and to provide a ranking of these treatment options. We looked at different outcomes like reduction in pain, prevention of different skeletal-related events, occurrence of adverse events, and quality of life. We wanted to find out which bone-modifying agent is most effective while causing the fewest adverse events when given as supportive treatment to men with prostate cancer and bone metastases."
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query-laysum | 3113 | [
{
"role": "user",
"content": "Abstract: Background\nStanding up from a seated position is one of the most frequently performed functional tasks, is an essential pre-requisite to walking and is important for independent living and preventing falls. Following stroke, patients can experience a number of problems relating to the ability to sit-to-stand independently.\nObjectives\nTo review the evidence of effectiveness of interventions aimed at improving sit-to-stand ability after stroke. The primary objectives were to determine (1) the effect of interventions that alter the starting posture (including chair height, foot position, hand rests) on ability to sit-to-stand independently; and (2) the effect of rehabilitation interventions (such as repetitive practice and exercise programmes) on ability to sit-to-stand independently. The secondary objectives were to determine the effects of interventions aimed at improving ability to sit-to-stand on: (1) time taken to sit-to-stand; (2) symmetry of weight distribution during sit-to-stand; (3) peak vertical ground reaction forces during sit-to-stand; (4) lateral movement of centre of pressure during sit-to-stand; and (5) incidence of falls.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (June 2013), CENTRAL (2013, Issue 5), MEDLINE (1950 to June 2013), EMBASE (1980 to June 2013), CINAHL (1982 to June 2013), AMED (1985 to June 2013) and six additional databases. We also searched reference lists and trials registers and contacted experts.\nSelection criteria\nRandomised trials in adults after stroke where: the intervention aimed to affect the ability to sit-to-stand by altering the posture of the patient, or the design of the chair; stated that the aim of the intervention was to improve the ability to sit-to-stand; or the intervention involved exercises that included repeated practice of the movement of sit-to-stand (task-specific practice of rising to stand).\nThe primary outcome of interest was the ability to sit-to-stand independently. Secondary outcomes included time taken to sit-to-stand, measures of lateral symmetry during sit-to-stand, incidence of falls and general functional ability scores.\nData collection and analysis\nTwo review authors independently screened abstracts, extracted data and appraised trials. We undertook an assessment of methodological quality for random sequence generation, allocation concealment, blinding of outcome assessors and method of dealing with missing data.\nMain results\nThirteen studies (603 participants) met the inclusion criteria for this review, and data from 11 of these studies were included within meta-analyses. Twelve of the 13 included studies investigated rehabilitation interventions; one (nine participants) investigated the effect of altered starting posture for sit-to-stand. We judged only four studies to be at low risk of bias for all methodological parameters assessed. The majority of randomised controlled trials included participants who were already able to sit-to-stand or walk independently.\nOnly one study (48 participants), which we judged to be at high risk of bias, reported our primary outcome of interest, ability to sit-to-stand independently, and found that training increased the odds of achieving independent sit-to-stand compared with control (odds ratio (OR) 4.86, 95% confidence interval (CI) 1.43 to 16.50, very low quality evidence).\nInterventions or training for sit-to-stand improved the time taken to sit-to-stand and the lateral symmetry (weight distribution between the legs) during sit-to-stand (standardised mean difference (SMD) -0.34; 95% CI -0.62 to -0.06, seven studies, 335 participants; and SMD 0.85; 95% CI 0.38 to 1.33, five studies, 105 participants respectively, both moderate quality evidence). These improvements are maintained at long-term follow-up.\nFew trials assessing the effect of sit-to-stand training on peak vertical ground reaction force (one study, 54 participants) and functional ability (two studies, 196 participants) were identified, providing very low and low quality evidence respectively.\nThe effect of sit-to-stand training on number of falls was imprecise, demonstrating no benefit or harm (OR 0.75, 95% CI 0.46 to 1.22, five studies, 319 participants, low quality evidence). We judged the majority of studies that assessed falls to be at high risk of bias.\nAuthors' conclusions\nThis review has found insufficient evidence relating to our primary outcome of ability to sit-to-stand independently to reach any generalisable conclusions. This review has found moderate quality evidence that interventions to improve sit-to-stand may have a beneficial effect on time taken to sit-to-stand and lateral symmetry during sit-to-stand, in the population of people with stroke who were already able to sit-to-stand independently. There was insufficient evidence to reach conclusions relating to the effect of interventions to improve sit-to-stand on peak vertical ground reaction force, functional ability and falls. This review adds to a growing body of evidence that repetitive task-specific training is beneficial for outcomes in people receiving rehabilitation following stroke.\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 found insufficient evidence relating to our primary outcome of ability to sit-to-stand independently to reach any generalisable conclusions. However, we found moderate quality evidence, from a relatively low number of small studies, that interventions to improve sit-to-stand may have a beneficial effect on the speed of rising to stand and the weight taken through the affected leg. We found insufficient evidence to reach any conclusions about the effect of sit-to-stand training on other outcomes. We recommend large clinical trials to confirm the results of this review, and to investigate the effects of different numbers of repetitions and durations of therapy. Future studies should include a measure of functional ability, and should measure long-term outcomes as well as outcomes straight after therapy."
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query-laysum | 3114 | [
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"role": "user",
"content": "Abstract: Background\nGuidelines have provided positive recommendations for pulmonary rehabilitation after exacerbations of chronic obstructive pulmonary disease (COPD), but recent studies indicate that postexacerbation rehabilitation may not always be effective in patients with unstable COPD.\nObjectives\nTo assess effects of pulmonary rehabilitation after COPD exacerbations on hospital admissions (primary outcome) and other patient-important outcomes (mortality, health-related quality of life (HRQL) and exercise capacity).\nSearch methods\nWe identified studies through searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro (Physiotherapy Evidence Database) and the Cochrane Airways Review Group Register of Trials. Searches were current as of 20 October 2015, and handsearches were run up to 5 April 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing pulmonary rehabilitation of any duration after exacerbation of COPD versus conventional care. Pulmonary rehabilitation programmes had to include at least physical exercise (endurance or strength exercise, or both). We did not apply a criterion for the minimum number of exercise sessions a rehabilitation programme had to offer to be included in the review. Control groups received conventional community care without rehabilitation.\nData collection and analysis\nWe expected substantial heterogeneity across trials in terms of how extensive rehabilitation programmes were (i.e. in terms of number of completed exercise sessions; type, intensity and supervision of exercise training; and patient education), duration of follow-up (< 3 months vs ≥ 3 months) and risk of bias (generation of random sequence, concealment of random allocation and blinding); therefore, we performed subgroup analyses that were defined before we carried them out. We used standard methods expected by Cochrane in preparing this update, and we used GRADE for assessing the quality of evidence.\nMain results\nFor this update, we added 11 studies and included a total of 20 studies (1477 participants). Rehabilitation programmes showed great diversity in terms of exercise training (number of completed exercise sessions; type, intensity and supervision), patient education (from none to extensive self-management programmes) and how they were organised (within one setting, e.g. pulmonary rehabilitation, to across several settings, e.g. hospital, outpatient centre and home). In eight studies, participants completed extensive pulmonary rehabilitation, and in 12 studies, participants completed pulmonary rehabilitation ranging from not extensive to moderately extensive.\nEight studies involving 810 participants contributed data on hospital readmissions. Moderate-quality evidence indicates that pulmonary rehabilitation reduced hospital readmissions (pooled odds ratio (OR) 0.44, 95% confidence interval (CI) 0.21 to 0.91), but results were heterogenous (I2 = 77%). Extensiveness of rehabilitation programmes and risk of bias may offer an explanation for the heterogeneity, but subgroup analyses were not statistically significant (P values for subgroup effects were between 0.07 and 0.11). Six studies including 670 participants contributed data on mortality. The quality of evidence was low, and the meta-analysis did not show a statistically significant effect of rehabilitation on mortality (pooled OR 0.68, 95% CI 0.28 to 1.67). Again, results were heterogenous (I2 = 59%). Subgroup analyses showed statistically significant differences in subgroup effects between trials with more and less extensive rehabilitation programmes and between trials at low and high risk for bias, indicating possible explanations for the heterogeneity. Hospital readmissions and mortality studies newly included in this update showed, on average, significantly smaller effects of rehabilitation than were seen in earlier studies.\nHigh-quality evidence suggests that pulmonary rehabilitation after an exacerbation improves health-related quality of life. The eight studies that used St George's Respiratory Questionnaire (SGRQ) reported a statistically significant effect on SGRQ total score, which was above the minimal important difference (MID) of four points (mean difference (MD) -7.80, 95% CI -12.12 to -3.47; I2 = 64%). Investigators also noted statistically significant and important effects (greater than MID) for the impact and activities domains of the SGRQ. Effects were not statistically significant for the SGRQ symptoms domain. Again, all of these analyses showed heterogeneity, but most studies showed positive effects of pulmonary rehabilitation, some studies showed large effects and others smaller but statistically significant effects. Trials at high risk of bias because of lack of concealment of random allocation showed statistically significantly larger effects on the SGRQ than trials at low risk of bias. High-quality evidence shows that six-minute walk distance (6MWD) improved, on average, by 62 meters (95% CI 38 to 86; I2 = 87%). Heterogeneity was driven particularly by differences between studies showing very large effects and studies showing smaller but statistically significant effects. For both health-related quality of life and exercise capacity, studies newly included in this update showed, on average, smaller effects of rehabilitation than were seen in earlier studies, but the overall results of this review have not changed to an important extent compared with results reported in the earlier version of this review.\nFive studies involving 278 participants explicitly recorded adverse events, four studies reported no adverse events during rehabilitation programmes and one study reported one serious event.\nAuthors' conclusions\nOverall, evidence of high quality shows moderate to large effects of rehabilitation on health-related quality of life and exercise capacity in patients with COPD after an exacerbation. Some recent studies showed no benefit of rehabilitation on hospital readmissions and mortality and introduced heterogeneity as compared with the last update of this review. Such heterogeneity of effects on hospital readmissions and mortality may be explained to some extent by the extensiveness of rehabilitation programmes and by the methodological quality of the included studies. Future researchers must investigate how the extent of rehabilitation programmes in terms of exercise sessions, self-management education and other components affects the outcomes, and how the organisation of such programmes within specific healthcare systems determines their effects after COPD exacerbations on hospital readmissions and mortality.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Pulmonary rehabilitation improves quality of life and exercise capacity and is a safe intervention for patients with COPD after they have experienced an exacerbation. The reasons for diverse effects on hospital readmissions and mortality, however, are not fully clear. Future studies should explore whether the extent of the rehabilitation programme and the organisation of such programmes within specific healthcare systems (e.g. within the rehabilitation setting vs embedded in the continuum of care from hospital to home to outpatient care) determines the effects of rehabilitation after COPD exacerbations."
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query-laysum | 3115 | [
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"role": "user",
"content": "Abstract: Background\nAcute limb ischaemia (ALI), the sudden and significant reduction of blood flow to the limb, is considered a vascular emergency. In the general population, the incidence is estimated as 14 per 100,000. Prognosis depends on the time it takes to diagnose the condition and begin appropriate treatment. Standard initial interventional treatments include conventional open surgery and endovascular interventions such as catheter-directed thrombolysis (CDT). Percutaneous interventions, such as percutaneous thrombectomy (PT, including mechanical thrombectomy or pharmomechanical thrombectomy) and ultrasound-accelerated thrombolysis (USAT), are also performed as alternative endovascular techniques. The proposed advantages of PT and USAT include reduced time to revascularisation and when combined with catheter-directed thrombolysis, a reduction in dose of thrombolytic agents and infusion time. The benefits of PT or USAT versus open surgery or thrombolysis alone are still uncertain. In this review, we compared PT or USAT against standard treatment for ALI, in an attempt to determine if any technique is comparatively safer and more effective.\nObjectives\nTo assess the safety and effectiveness of percutaneous thrombectomy or ultrasound-accelerated thrombolysis for the initial management of acute limb ischaemia in adults.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform, and ClinicalTrials.gov to 3 March 2021. We searched reference lists of relevant studies and papers.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared PT (any modality, including mechanical thrombectomy (aspiration, rheolysis, rotation) or pharmomechanical thrombectomy) or USAT with open surgery, thrombolysis alone, no treatment, or another PT modality for the treatment of ALI.\nData collection and analysis\nTwo review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and assessed the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.\nMain results\nWe included one RCT in this review. This study had a total of 60 participants and compared USAT with standard treatment (CDT). The study included 32 participants in the CDT group and 28 participants in the USAT group.\nWe found no evidence of a difference between USAT and CDT alone for the following evaluated outcomes: amputation rate (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.17 to 7.59); major bleeding (RR 1.71, 95% CI 0.31 to 9.53); clinical success (RR 1.00, 95% CI 0.94 to 1.07); and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (there was a high risk of bias in critical domains) and by two further levels due to imprecision (a small number of participants and only one study included). The study authors reported 30-day patency, but did not report primary and secondary patency separately. The patency rate in the successfully lysed participants was 71% (15/21) in the USAT group and 82% (22/27) in the CDT group. The study authors did not directly report secondary patency, which is patency after secondary procedures, but they did report on secondary procedures. Secondary procedures were subdivided into embolectomy and bypass grafting. Embolectomy was performed on 14% (4/28) of participants in the USAT group versus 3% (1/32) of participants in the CDT group. Bypass grafting was performed on 4% (1/28) of participants in the USAT group versus 0% in the CDT group. As we did not have access to the specific participant data, it was not possible to assess these outcomes further.\nWe did not identify studies comparing the other planned interventions.\nAuthors' conclusions\nThere is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI for our evaluated outcomes: amputation rate, major bleeding, clinical success, and adverse effects. Primary and secondary patency were not reported separately. There was no RCT evidence for PT. Limitations of this systematic review derive from the single included study, small sample size, short clinical follow-up period, and high risk of bias in critical domains. For this reason, the applicability of the results is limited. There is a need for high-quality studies to compare PT or USAT against open surgery, thrombolysis alone, no treatment, or other PT modalities for ALI. Future trials should assess outcomes, such as primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse 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"
},
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"role": "assistant",
"content": "Because of a lack of robust evidence, the benefits and risks of percutaneous blood clot removal (the removal of a blood clot via a needle puncture in the skin, known as percutaneous thrombectomy) or ultrasound-accelerated thrombolysis (where ultrasound waves are sent by a specific device into the blood vessel to accelerate the dissolution of a blood clot) for the initial treatment of acute limb ischaemia are unclear.\nFuture research in this area should focus on the effectiveness of treatment options such as blood clot removal, catheter-directed thrombolysis (drug delivery into the blood clot to dissolve the clot), and open surgery (to remove the clot and improve blood flow), as well as investigating any unwanted effects of these treatments."
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query-laysum | 3116 | [
{
"role": "user",
"content": "Abstract: Background\nKnee arthroscopy is a common procedure and is associated with postoperative pain. Intra-articular (IA) injection of morphine for pain control has been widely studied, but its analgesic effect after knee arthroscopy is uncertain.\nObjectives\nTo evaluate the relative effects on pain relief and adverse events of IA morphine given for pain control after knee arthroscopy compared with placebo, other analgesics (local anaesthetics, non-steroidal anti-inflammatory drugs (NSAIDs), other opioids) and other routes of morphine administration.\nSearch methods\nWe searched CENTRAL (The Cochrane Library Issue 4, 2015), MEDLINE via Ovid (January 1966 to May 2015), EMBASE via Ovid (January 1988 to May 2015), and the reference lists of included articles. We also searched the metaRegister of controlled trials, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing trials.\nSelection criteria\nWe identified all the randomised, double-blind controlled trials that compared single dose IA morphine with other interventions for the treatment of postoperative pain after knee arthroscopy. We excluded studies with fewer than 10 participants in each group, using spinal or epidural anaesthesia, or assessing the analgesic effect of IA morphine on chronic pain.\nData collection and analysis\nTwo authors independently assessed the quality of each trial and extracted information on pain intensity, supplementary analgesics consumption and adverse events. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created 'Summary of findings' tables.\nMain results\nWe included 28 small, low quality studies (29 reports) involving 2564 participants. Of 20 studies (21 reports) comparing morphine with placebo, nine studies with adequate data were included in the meta-analysis. Overall, the risk of bias was unclear. Overall, the quality of the evidence assessed using GRADE was low to very low, downgraded primarily due to risk of bias, small study size, and imprecision.\nNo statistical difference was found between 1 mg IA morphine and placebo in pain intensity (visual analogue scale (VAS)) at early phase (zero to two hours) (mean difference (MD) -0.50, 95% CI -1.15 to 0.14; participants = 297; studies = 7; low quality evidence), medium phase (two to six hours) (MD -0.47, 95% CI -1.09 to 0.14; participants = 297; studies = 7; low quality evidence) and late phase (six to 30 hours) (MD -0.88, 95% CI -1.81 to 0.04; participants = 297; studies = 7; low quality evidence). No significant difference was found between 1 mg and 2 mg morphine for pain intensity at early phase (MD -0.56, 95% CI -1.93 to 0.81; participants = 105; studies = 2; low quality evidence), while 4 mg/5 mg morphine provided better analgesia than 1 mg morphine at late phase (MD 0.67, 95% CI 0.08 to 1.25; participants = 97; studies = 3; low quality evidence). IA morphine was not better than local anaesthetic agents at early phase (MD 1.43, 95% CI 0.49 to 2.37; participants = 248; studies = 5; low quality evidence), NSAIDs at early phase (MD 0.95, 95% CI -0.95 to 2.85; participants = 80; studies = 2; very low quality evidence), sufentanil, fentanyl or pethidine for pain intensity. IA morphine was similar to intramuscular (IM) morphine for pain intensity at early phase (MD 0.21, 95% CI -0.48 to 0.90; participants = 72; studies = 2; very low quality evidence).\nMeta-analysis indicated that there was no difference between IA morphine and placebo or bupivacaine in time to first analgesic request. Eleven out of 20 studies comparing morphine with placebo reported adverse events and no statistical difference was obtained regarding the incidence of adverse events (risk ratio (RR) 1.09, 95% CI 0.51 to 2.36; participants = 314; studies = 8; low quality evidence). Seven of 28 studies reported participants' withdrawal. There were not enough data for withdrawals to be able to perform meta-analysis.\nAuthors' conclusions\nWe have not found high quality evidence that 1 mg IA morphine is better than placebo at reducing pain intensity at early, medium or late phases. No statistical difference was reported between IA morphine and placebo regarding the incidence of adverse events. The relative effects of 1 mg morphine when compared with IA bupivacaine, NSAIDs, sufentanil, fentanyl and pethidine are uncertain. The quality of the evidence is limited by high risk of bias and small size of the included studies, which might bias the results. More high quality studies are needed to get more conclusive results.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In May 2015, this review identified 28 small, low quality studies involving 2564 participants looking at intra-articular morphine for pain relief after knee arthroscopy. From 9/20 studies we did not find evidence that intra-articular morphine given at a dose of 1 mg was better than placebo for pain relief. From the limited evidence available we were unable to determine how intra-articular morphine compared with morphine injected into the muscle (intra-muscular morphine). There was also low quality evidence for the effects of 1 mg intra-articular morphine compared with intra-articular bupivacaine, non-steroidal anti-inflammatory drugs (NSAIDs), sufentanil, fentanyl and pethidine, so we were unsure which worked best. We were unable to determine how similar the rates of side effects such as nausea and vomiting were between intra-articular morphine and placebo. Overall, the quality of the evidence was low.\nFuture research should focus on finding effective analgesics for knee arthroscopy."
}
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query-laysum | 3117 | [
{
"role": "user",
"content": "Abstract: Background\nCongenital heart disease is the most commonly diagnosed neonatal congenital condition. Without surgery, only 30% to 40% of patients affected will survive to 10 years old. Mortality has fallen since the 1990s with 2006 to 2007 figures showing surgical survival at one year of 95%. Patients with congenital heart disease are potentially exposed to red cell transfusion at many points in the surgical pathway. There are a number of risks associated with red cell transfusion that may be translated into increased patient morbidity and mortality.\nObjectives\nTo evaluate the effects of red cell transfusion on mortality and morbidity on patients with congenital heart disease at the time of cardiac surgery.\nSearch methods\nWe searched 11 bibliographic databases and three ongoing trials databases including the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2013), MEDLINE (Ovid, 1950 to 11 June 2013), EMBASE (Ovid, 1980 to 11 June 2013), ClinicalTrials.gov, World Health Organization (WHO) ICTRP and the ISRCTN Register (to June 2013). We also searched references of all identified trials, relevant review articles and abstracts from between 2006 and 2010 of the most relevant conferences. We did not limit the searches by language of publication.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing red cell transfusion interventions in patients undergoing cardiac surgery for congenital heart disease. We included participants of any age (neonates, paediatrics and adults) and with any type of congenital heart disease (cyanotic or acyanotic). We excluded patients with congenital heart disease undergoing non-cardiac surgery. No co-morbidities were excluded.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors for additional information.\nMain results\nWe identified 11 trials (862 participants). All trials were in neonatal or paediatric populations. The trials covered only three areas of interest: restrictive versus liberal transfusion triggers (two trials), leukoreduction versus non-leukoreduction (two trials) and standard versus non-standard cardiopulmonary bypass (CPB) prime (seven trials). Owing to the clinical diversity in the participant groups (cyanotic (three trials), acyanotic (four trials) or mixed (four trials)) and the intervention groups, it was not appropriate to pool data in a meta-analysis. No study reported data for all the outcomes of interest to this review. Risk of bias was mixed across the included trials, with only attrition bias being low across all trials. Blinding of study personnel and participants was not always possible, depending on the intervention being used.\nFive trials (628 participants) reported the primary outcome: 30-day mortality. In three trials (a trial evaluating restrictive and liberal transfusion (125 participants), a trial of cell salvage during CPB (309 participants) and a trial of washed red blood cells during CPB (128 participants)), there was no clear difference in mortality at 30 days between the intervention arms. In two trials comparing standard and non-standard CPB prime, there were no deaths in either randomised group. Long-term mortality was similar between randomised groups in one trial each comparing restrictive and liberal transfusion or standard and non-standard CPB prime.\nFour trials explored a range of adverse effects following red cell transfusion. Kidney failure was the only adverse event that was significantly different: patients receiving cell salvaged red blood cells during CPB were less likely to have renal failure than patients not exposed to cell salvage (risk ratio (RR) 0.26, 95% confidence interval (CI) 0.09 to 0.79, 1 study, 309 participants). There was insufficient evidence to determine whether there was a difference between transfusion strategies for any other severe adverse events.\nThe duration of mechanical ventilation was measured in seven trials (768 participants). Overall, there was no consistent difference in the duration of mechanical ventilation between the intervention and control arms.\nThe duration of intensive care unit (ICU) stay was measured in six trials (459 participants). There was no clear difference in the duration of ICU stay between the intervention arms in the transfusion trigger and leukoreduction trials. In the standard versus non-standard CPB prime trials, one trial examining the impact of washing transfused bypass prime red blood cells showed no clear difference in duration of ICU stay between the intervention arms, while the trial assessing ultrafiltration of the priming blood showed a shorter duration of ICU stay in the ultrafiltration group.\nAuthors' conclusions\nThere are only a small number of small and heterogeneous trials so there is insufficient evidence to assess the impact of red cell transfusion on patients with congenital heart disease undergoing cardiac surgery accurately. It is possible that the presence or absence of cyanosis impacts on trial outcomes, which would necessitate different clinical management of two groups. Further adequately powered, specific, high-quality trials are warranted to assess this fully.\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": "This review identified only a few, small studies across three interventions. These studies measured many different aspects of red blood cell transfusion in patients having heart surgery so it is difficult to make accurate conclusions about the benefits or risks of red blood cell transfusion for these patients. More research is needed to allow accurate conclusions. Future studies should be bigger and focus on one aspect of transfusion in a specific type of heart disease."
}
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query-laysum | 3118 | [
{
"role": "user",
"content": "Abstract: Background\nActive smoking increases the risk of tuberculosis (TB) infection 2 to 2.5 times and is significantly associated with recurrent TB and TB mortality. Observational studies have shown associations between smoking and poor TB treatment outcomes such as increased loss to follow-up rate, severity of disease, drug resistance and slow smear conversion. Since most smoking-related immunologic abnormalities are reversible within six weeks of stopping smoking, smoking cessation may have substantial positive effects on TB treatment outcomes, TB relapse and future lung disease.\nObjectives\nTo analyse the effect of tobacco smoking cessation interventions (SCIs) on the treatment outcomes of people with adult pulmonary TB.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register using free-text and MeSH terms for TB and antitubercular treatment. We also searched MEDLINE and EMBASE using the same topic-related terms, combined with the search terms used to identify trials of tobacco cessation interventions from the Specialised Register. We also searched reference list of articles and reviews, the Conference Paper Index, clinicaltrials.gov and grey literature. The searches are current to 29th July 2015.\nSelection criteria\nIndividual and cluster-randomised controlled trials (RCTs), regardless of date, language and publication status, studies of adults with pulmonary TB on first-line anti-tubercular drugs, with interventions at either an individual or a population level, delivered separately or as part of a larger tobacco control package. This included any type of behavioural or pharmaceutical intervention or both for smoking cessation.\nData collection and analysis\nUsing the eligibility criteria, two authors independently checked the abstracts of retrieved studies for relevance, and acquired full trial reports of candidates for inclusion. The authors resolved any disagreements on eligibility by mutual consent, or by recourse to a third author. Two authors intended to independently extract study data from eligible studies into a data extraction form and compare the findings, synthesise data using risk ratios, and assess risk of bias using standard Cochrane methodologies. However, we found no eligible trials.\nMain results\nThere were no randomised controlled trials that met the eligibility criteria. A number of potentially eligible studies are underway, and we will assess them for inclusion in the next update of this review.\nAuthors' conclusions\nThere is a lack of high-quality evidence, i.e. RCTs, that tests the effectiveness of cessation interventions in improving TB treatment outcomes. There is a need for good-quality randomised controlled trials that assess the effect of SCIs on TB treatment outcomes in both the short and long term. Establishing such an evidence base would be an essential step towards the implementation of SCIs in TB control programmes worldwide.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is as yet no high-quality evidence that can tell us whether treatments to help people with TB to stop smoking also help them to complete their TB treatment and to respond better to that treatment. There is therefore a need for good-quality research studies that test the usefulness of treatments to quit smoking in people with TB."
}
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query-laysum | 3120 | [
{
"role": "user",
"content": "Abstract: Background\nAround a third of people with schizophrenia or related serious mental illness will be a parent. Both the parents and the children in this population are at increased risk of adverse outcomes due to parental mental illness. Parenting interventions are known to improve parenting skills and decrease child disruptive behaviour. This systematic review aimed to synthesise the evidence base for parenting interventions designed specifically for parents who have schizophrenia or related serious mental illness.\nObjectives\nTo assess the effects of parenting interventions for people with schizophrenia or related serious mental illness.\nSearch methods\nOn 10 February 2021 we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on the following: Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.Gov, Embase, International Standard Randomised Controlled Trial Number (ISRCTN), MEDLINE, PsycINFO, PubMed, and the World Health Organization International Clinical Trials Registry Platform.\nSelection criteria\nEligible studies were randomised controlled trials (RCTs) that compared parenting interventions with a control condition for people with schizophrenia or related serious mental illness with a child between the ages of 0 and 18 years.\nData collection and analysis\nWe independently inspected citations, selected studies, extracted data and appraised study quality. We assessed risk of bias for included studies.\nMain results\nWe only included one trial (n = 50), and it was not possible to extract any data because the authors did not provide any means and standard deviations for our outcomes of interest; they only reported whether outcomes were significant or not at the 0.05 level. Three domains of the trial were rated as having a high risk of bias.\nAuthors' conclusions\nThe only included trial provided inconclusive evidence. There is insufficient evidence to make recommendations to people with schizophrenia (or related serious mental illness) or clinicians, or for policy changes. Although there is no RCT evidence, parenting interventions for people with schizophrenia or related serious mental illness have been developed. Future research should test these in RCTs in order to improve the evidence base for this population.\n\nGiven the provided abstract, please respond to the following query: \"Searching\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We ran an electronic search in March 2020 and February 2021 for randomised controlled trials of parenting programmes aimed at people with schizophrenia or related serious mental illness. We found 36 studies and checked these to see if they were relevant to our research."
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query-laysum | 3121 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a malignant plasma cell disorder characterised by clonal plasma cells that cause end-organ damage such as renal failure, lytic bone lesions, hypercalcaemia and/or anaemia. People with multiple myeloma are treated with immunomodulatory agents including lenalidomide, pomalidomide, and thalidomide. Multiple myeloma is associated with an increased risk of thromboembolism, which appears to be further increased in people receiving immunomodulatory agents.\nObjectives\n(1) To systematically review the evidence for the relative efficacy and safety of aspirin, oral anticoagulants, or parenteral anticoagulants in ambulatory patients with multiple myeloma receiving immunomodulatory agents who otherwise have no standard therapeutic or prophylactic indication for anticoagulation.\n(2) To maintain this review as a living systematic review by continually running the searches and incorporating newly identified studies.\nSearch methods\nWe conducted a comprehensive literature search that included (1) a major electronic search (14 June 2021) of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE via Ovid, and Embase via Ovid; (2) hand-searching of conference proceedings; (3) checking of reference lists of included studies; and (4) a search for ongoing studies in trial registries. As part of the living systematic review approach, we are running continual searches, and we will incorporate new evidence rapidly after it is identified.\nSelection criteria\nRandomised controlled trials (RCTs) assessing the benefits and harms of oral anticoagulants such as vitamin K antagonist (VKA) and direct oral anticoagulants (DOAC), anti-platelet agents such as aspirin (ASA), and parenteral anticoagulants such as low molecular weight heparin (LMWH)in ambulatory patients with multiple myeloma receiving immunomodulatory agents.\nData collection and analysis\nUsing a standardised form, we extracted data in duplicate on study design, participants, interventions, outcomes of interest, and risk of bias. Outcomes of interest included all-cause mortality, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), major bleeding, and minor bleeding. For each outcome we calculated the risk ratio (RR) with its 95% confidence interval (CI) and the risk difference (RD) with its 95% CI. We then assessed the certainty of evidence at the outcome level following the GRADE approach (GRADE Handbook).\nMain results\nWe identified 1015 identified citations and included 11 articles reporting four RCTs that enrolled 1042 participants. The included studies made the following comparisons: ASA versus VKA (one study); ASA versus LMWH (two studies); VKA versus LMWH (one study); and ASA versus DOAC (two studies, one of which was an abstract).\nASA versus VKA\nOne RCT compared ASA to VKA at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to VKA on all-cause mortality (RR 3.00, 95% CI 0.12 to 73.24; RD 2 more per 1000, 95% CI 1 fewer to 72 more; very low-certainty evidence); symptomatic DVT (RR 0.57, 95% CI 0.24 to 1.33; RD 27 fewer per 1000, 95% CI 48 fewer to 21 more; very low-certainty evidence); PE (RR 1.00, 95% CI 0.25 to 3.95; RD 0 fewer per 1000, 95% CI 14 fewer to 54 more; very low-certainty evidence); major bleeding (RR 7.00, 95% CI 0.36 to 134.72; RD 6 more per 1000, 95% CI 1 fewer to 134 more; very low-certainty evidence); and minor bleeding (RR 6.00, 95% CI 0.73 to 49.43; RD 23 more per 1000, 95% CI 1 fewer to 220 more; very low-certainty evidence).\nOne RCT compared ASA to VKA at two years follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to VKA on all-cause mortality (RR 0.50, 95% CI 0.05 to 5.47; RD 5 fewer per 1000, 95% CI 9 fewer to 41 more; very low-certainty evidence); symptomatic DVT (RR 0.71, 95% CI 0.35 to 1.44; RD 22 fewer per 1000, 95% CI 50 fewer to 34 more; very low-certainty evidence); and PE (RR 1.00, 95% CI 0.25 to 3.95; RD 0 fewer per 1000, 95% CI 14 fewer to 54 more; very low-certainty evidence).\nASA versus LMWH\nTwo RCTs compared ASA to LMWH at six months follow-up. The pooled data did not confirm or exclude a beneficial or detrimental effect of ASA relative to LMWH on all-cause mortality (RR 1.00, 95% CI 0.06 to 15.81; RD 0 fewer per 1000, 95% CI 2 fewer to 38 more; very low-certainty evidence); symptomatic DVT (RR 1.23, 95% CI 0.49 to 3.08; RD 5 more per 1000, 95% CI 11 fewer to 43 more; very low-certainty evidence); PE (RR 7.71, 95% CI 0.97 to 61.44; RD 7 more per 1000, 95% CI 0 fewer to 60 more; very low-certainty evidence); major bleeding (RR 6.97, 95% CI 0.36 to 134.11; RD 6 more per 1000, 95% CI 1 fewer to 133 more; very low-certainty evidence); and minor bleeding (RR 1.42, 95% CI 0.35 to 5.78; RD 4 more per 1000, 95% CI 7 fewer to 50 more; very low-certainty evidence).\nOne RCT compared ASA to LMWH at two years follow-up. The pooled data did not confirm or exclude a beneficial or detrimental effect of ASA relative to LMWH on all-cause mortality (RR 1.00, 95% CI 0.06 to 15.89; RD 0 fewer per 1000, 95% CI 4 fewer to 68 more; very low-certainty evidence); symptomatic DVT (RR 1.20, 95% CI 0.53 to 2.72; RD 9 more per 1000, 95% CI 21 fewer to 78 more; very low-certainty evidence); and PE (RR 9.00, 95% CI 0.49 to 166.17; RD 8 more per 1000, 95% CI 1 fewer to 165 more; very low-certainty evidence).\nVKA versus LMWH\nOne RCT compared VKA to LMWH at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of VKA relative to LMWH on all-cause mortality (RR 0.33, 95% CI 0.01 to 8.10; RD 3 fewer per 1000, 95% CI 5 fewer to 32 more; very low-certainty evidence); symptomatic DVT (RR 2.32, 95% CI 0.91 to 5.93; RD 36 more per 1000, 95% CI 2 fewer to 135 more; very low-certainty evidence); PE (RR 8.96, 95% CI 0.49 to 165.42; RD 8 more per 1000, 95% CI 1 fewer to 164 more; very low-certainty evidence); and minor bleeding (RR 0.33, 95% CI 0.03 to 3.17; RD 9 fewer per 1000, 95% CI 13 fewer to 30 more; very low-certainty evidence). The study reported that no major bleeding occurred in either arm.\nOne RCT compared VKA to LMWH at two years follow-up. The data did not confirm or exclude a beneficial or detrimental effect of VKA relative to LMWH on all-cause mortality (RR 2.00, 95% CI 0.18 to 21.90; RD 5 more per 1000, 95% CI 4 fewer to 95 more; very low-certainty evidence); symptomatic DVT (RR 1.70, 95% CI 0.80 to 3.63; RD 32 more per 1000, 95% CI 9 fewer to 120 more; very low-certainty evidence); and PE (RR 9.00, 95% CI 0.49 to 166.17; RD 8 more per 1000, 95% CI 1 fewer to 165 more; very low-certainty evidence).\nASA versus DOAC\nOne RCT compared ASA to DOAC at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to DOAC on DVT, PE, and major bleeding and minor bleeding (minor bleeding: RR 5.00, 95% CI 0.31 to 79.94; RD 4 more per 1000, 95% CI 1 fewer to 79 more; very low-certainty evidence). The study reported that no DVT, PE, or major bleeding events occurred in either arm. These results did not change in a meta-analysis including the study published as an abstract.\nAuthors' conclusions\nThe certainty of the available evidence for the comparative effects of ASA, VKA, LMWH, and DOAC on all-cause mortality, DVT, PE, or bleeding was either low or very low. People with multiple myeloma considering antithrombotic agents should balance the possible benefits of reduced thromboembolic complications with the possible harms and burden of anticoagulants.\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 included four studies enrolling a total of 1042 people with multiple myeloma. The included studies made the following comparisons: aspirin (oral medication used to prevent blood clots) to vitamin K antagonist (VKA) (oral blood thinner) (one study); aspirin to low molecular weight heparin (LMWH) (injectable blood thinner) (two studies); VKA to LMWH (one study); and aspirin to direct oral anticoagulants (oral blood thinner) (two studies). In people with multiple myeloma receiving thalidomide, the data do not provide a clear answer about the comparative effect of these drugs on all of the studied outcomes (death, blood clots, bleeding)."
}
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query-laysum | 3122 | [
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for individuals with fibromyalgia. This review examined the effects of supervised group aquatic training programs (led by an instructor). We defined aquatic training as exercising in a pool while standing at waist, chest, or shoulder depth. This review is part of the update of the 'Exercise for treating fibromyalgia syndrome' review first published in 2002, and previously updated in 2007.\nObjectives\nThe objective of this systematic review was to evaluate the benefits and harms of aquatic exercise training in adults with fibromyalgia.\nSearch methods\nWe searched The Cochrane Library 2013, Issue 2 (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, NHS Economic Evaluation Database), MEDLINE, EMBASE, CINAHL, PEDro, Dissertation Abstracts, WHO international Clinical Trials Registry Platform, and AMED, as well as other sources (i.e., reference lists from key journals, identified articles, meta-analyses, and reviews of all types of treatment for fibromyalgia) from inception to October 2013. Using Cochrane methods, we screened citations, abstracts, and full-text articles. Subsequently, we identified aquatic exercise training studies.\nSelection criteria\nSelection criteria were: a) full-text publication of a randomized controlled trial (RCT) in adults diagnosed with fibromyalgia based on published criteria, and b) between-group data for an aquatic intervention and a control or other intervention. We excluded studies if exercise in water was less than 50% of the full intervention.\nData collection and analysis\nWe independently assessed risk of bias and extracted data (24 outcomes), of which we designated seven as major outcomes: multidimensional function, self reported physical function, pain, stiffness, muscle strength, submaximal cardiorespiratory function, withdrawal rates and adverse effects. We resolved discordance through discussion. We evaluated interventions using mean differences (MD) or standardized mean differences (SMD) and 95% confidence intervals (95% CI). Where two or more studies provided data for an outcome, we carried out meta-analysis. In addition, we set and used a 15% threshold for calculation of clinically relevant differences.\nMain results\nWe included 16 aquatic exercise training studies (N = 881; 866 women and 15 men). Nine studies compared aquatic exercise to control, five studies compared aquatic to land-based exercise, and two compared aquatic exercise to a different aquatic exercise program.\nWe rated the risk of bias related to random sequence generation (selection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), blinding of outcome assessors (detection bias), and other bias as low. We rated blinding of participants and personnel (selection and performance bias) and allocation concealment (selection bias) as low risk and unclear. The assessment of the evidence showed limitations related to imprecision, high statistical heterogeneity, and wide confidence intervals.\nAquatic versus control\nWe found statistically significant improvements (P value < 0.05) in all of the major outcomes. Based on a 100-point scale, multidimensional function improved by six units (MD -5.97, 95% CI -9.06 to -2.88; number needed to treat (NNT) 5, 95% CI 3 to 9), self reported physical function by four units (MD -4.35, 95% CI -7.77 to -0.94; NNT 6, 95% CI 3 to 22), pain by seven units (MD -6.59, 95% CI -10.71 to -2.48; NNT 5, 95% CI 3 to 8), and stiffness by 18 units (MD -18.34, 95% CI -35.75 to -0.93; NNT 3, 95% CI 2 to 24) more in the aquatic than the control groups. The SMD for muscle strength as measured by knee extension and hand grip was 0.63 standard deviations higher compared to the control group (SMD 0.63, 95% CI 0.20 to 1.05; NNT 4, 95% CI 3 to 12) and cardiovascular submaximal function improved by 37 meters on six-minute walk test (95% CI 4.14 to 69.92). Only two major outcomes, stiffness and muscle strength, met the 15% threshold for clinical relevance (improved by 27% and 37% respectively). Withdrawals were similar in the aquatic and control groups and adverse effects were poorly reported, with no serious adverse effects reported.\nAquatic versus land-based\nThere were no statistically significant differences between interventions for multidimensional function, self reported physical function, pain or stiffness: 0.91 units (95% CI -4.01 to 5.83), -5.85 units (95% CI -12.33 to 0.63), -0.75 units (95% CI -10.72 to 9.23), and two units (95% CI -8.88 to 1.28) respectively (all based on a 100-point scale), or in submaximal cardiorespiratory function (three seconds on a 100-meter walk test, 95% CI -1.77 to 7.77). We found a statistically significant difference between interventions for strength, favoring land–based training (2.40 kilo pascals grip strength, 95% CI 4.52 to 0.28). None of the outcomes in the aquatic versus land comparison reached clinically relevant differences of 15%. Withdrawals were similar in the aquatic and land groups and adverse effects were poorly reported, with no serious adverse effects in either group.\nAquatic versus aquatic (Ai Chi versus stretching in the water, exercise in pool water versus exercise in sea water)\nAmong the major outcomes the only statistically significant difference between interventions was for stiffness, favoring Ai Chi (1.00 on a 100-point scale, 95% CI 0.31 to 1.69).\nAuthors' conclusions\nLow to moderate quality evidence relative to control suggests that aquatic training is beneficial for improving wellness, symptoms, and fitness in adults with fibromyalgia. Very low to low quality evidence suggests that there are benefits of aquatic and land-based exercise, except in muscle strength (very low quality evidence favoring land). No serious adverse effects were reported.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence - aquatic versus control\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Further research on overall well being and ability to function is likely to have an important impact on our confidence in these results and may change the results.\nFurther research on pain, stiffness, muscle strength, and cardiovascular fitness is very likely to have an important impact on our confidence in these results and is likely to change the results."
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query-laysum | 3123 | [
{
"role": "user",
"content": "Abstract: Background\nVentilator-associated pneumonia (VAP) is one of the most common nosocomial infections in intubated and mechanically ventilated patients. Endotracheal tubes (ETTs) appear to be an independent risk factor for VAP. Silver-coated ETTs slowly release silver cations. It is these silver ions that appear to have a strong antimicrobial effect. Because of this antimicrobial effect of silver, silver-coated ETTs could be an effective intervention to prevent VAP in people who require mechanical ventilation for 24 hours or longer.\nObjectives\nOur primary objective was to investigate whether silver-coated ETTs are effective in reducing the risk of VAP and hospital mortality in comparison with standard non-coated ETTs in people who require mechanical ventilation for 24 hours or longer. Our secondary objective was to ascertain whether silver-coated ETTs are effective in reducing the following clinical outcomes: device-related adverse events, duration of intubation, length of hospital and intensive care unit (ICU) stay, costs, and time to VAP onset.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014 Issue 10, MEDLINE, EMBASE, EBSCO CINAHL, and reference lists of trials. We contacted corresponding authors for additional information and unpublished studies. We did not impose any restrictions on the basis of date of publication or language. The date of the last search was October 2014.\nSelection criteria\nWe included all randomized controlled trials (RCTs) and quasi-randomized trials that evaluated the effects of silver-coated ETTs or a combination of silver with any antimicrobial-coated ETTs with standard non-coated ETTs or with other antimicrobial-coated ETTs in critically ill people who required mechanical ventilation for 24 hours or longer. We also included studies that evaluated the cost-effectiveness of silver-coated ETTs or a combination of silver with any antimicrobial-coated ETTs.\nData collection and analysis\nTwo review authors (GT, HV) independently extracted the data and summarized study details from all included studies using the specially designed data extraction form. We used standard methodological procedures expected by The Cochrane Collaboration. We performed meta-analysis for outcomes when possible.\nMain results\nWe found three eligible randomized controlled trials, with a total of 2081 participants. One of the three included studies did not mention the amount of participants and presented no outcome data. The 'Risk of bias' assessment indicated that there was a high risk of detection bias owing to lack of blinding of outcomes assessors, but we assessed all other domains to be at low risk of bias. Trial design and conduct were generally adequate, with the most common areas of weakness in blinding. The majority of participants were included in centres across North America. The mean age of participants ranged from 61 to 64 years, and the mean duration of intubation was between 3.2 and 7.7 days. One trial comparing silver-coated ETTs versus non-coated ETTs showed a statistically significant decrease in VAP in favour of the silver-coated ETT (1 RCT, 1509 participants; 4.8% versus 7.5%, risk ratio (RR) 0.64, 95% confidence interval (CI) 0.43 to 0.96; number needed to treat for an additional beneficial outcome (NNTB) = 37; low-quality evidence). The risk of VAP within 10 days of intubation was significantly lower with the silver-coated ETTs compared with non-coated ETTs (1 RCT, 1509 participants; 3.5% versus 6.7%, RR 0.51, 95% CI 0.31 to 0.82; NNTB = 32; low-quality evidence). Silver-coated ETT was associated with delayed time to VAP occurrence compared with non-coated ETT (1 RCT, 1509 participants; hazard ratio 0.55, 95% CI 0.37 to 0.84). The confidence intervals for the results of the following outcomes did not exclude potentially important differences with either treatment. There were no statistically significant differences between groups in hospital mortality (1 RCT, 1509 participants; 30.4% versus 26.6%, RR 1.09, 95% CI 0.93 to 1.29; low-quality evidence); device-related adverse events (2 RCTs, 2081 participants; RR 0.65, 95% CI 0.37 to 1.16; low-quality evidence); duration of intubation; and length of hospital and ICU stay. We found no clinical studies evaluating the cost-effectiveness of silver-coated ETTs.\nAuthors' conclusions\nThis review provides limited evidence that silver-coated ETT reduces the risk of VAP, especially during the first 10 days of mechanical ventilation.\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 reviewed the evidence of whether silver-coated endotracheal tubes (ETTs) are effective in reducing the risk of ventilator-associated pneumonia (VAP) and hospital mortality in comparison with standard non-coated ETTs in people who require mechanical ventilation for 24 hours or longer."
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"content": "Abstract: Background\nChildren's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. This is the second update of the Cochrane Review first published in 2005 and previously updated in 2012.\nObjectives\nTo evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 22 February 2018); MEDLINE Ovid (1946 to 22 February 2018); and Embase Ovid (1980 to 22 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nStudies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. We excluded cross-over trials.\nData collection and analysis\nTwo review authors independently extracted, in duplicate, information regarding methods, participants, interventions, outcome measures and results. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. Cochrane statistical guidelines were followed.\nMain results\nWe included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I2 = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both.\nAuthors' conclusions\nThere is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is a need for further well-designed and well-reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There is some moderate-certainty evidence that midazolam administered in a drink of juice is effective."
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"content": "Abstract: Background\nBacterial folliculitis and boils are globally prevalent bacterial infections involving inflammation of the hair follicle and the perifollicular tissue. Some folliculitis may resolve spontaneously, but others may progress to boils without treatment. Boils, also known as furuncles, involve adjacent tissue and may progress to cellulitis or lymphadenitis. A systematic review of the best evidence on the available treatments was needed.\nObjectives\nTo assess the effects of interventions (such as topical antibiotics, topical antiseptic agents, systemic antibiotics, phototherapy, and incision and drainage) for people with bacterial folliculitis and boils.\nSearch methods\nWe searched the following databases up to June 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched five trials registers up to June 2020. We checked the reference lists of included studies and relevant reviews for further relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that assessed systemic antibiotics; topical antibiotics; topical antiseptics, such as topical benzoyl peroxide; phototherapy; and surgical interventions in participants with bacterial folliculitis or boils. Eligible comparators were active intervention, placebo, or no treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were 'clinical cure' and 'severe adverse events leading to withdrawal of treatment'; secondary outcomes were 'quality of life', 'recurrence of folliculitis or boil following completion of treatment', and 'minor adverse events not leading to withdrawal of treatment'. We used GRADE to assess the certainty of the evidence.\nMain results\nWe included 18 RCTs (1300 participants). The studies included more males (332) than females (221), although not all studies reported these data. Seventeen trials were conducted in hospitals, and one was conducted in clinics. The participants included both children and adults (0 to 99 years). The studies did not describe severity in detail; of the 232 participants with folliculitis, 36% were chronic. At least 61% of participants had furuncles or boils, of which at least 47% were incised. Duration of oral and topical treatments ranged from 3 days to 6 weeks, with duration of follow-up ranging from 3 days to 6 months. The study sites included Asia, Europe, and America. Only three trials reported funding, with two funded by industry.\nTen studies were at high risk of 'performance bias', five at high risk of 'reporting bias', and three at high risk of 'detection bias'.\nWe did not identify any RCTs comparing topical antibiotics against topical antiseptics, topical antibiotics against systemic antibiotics, or phototherapy against sham light. Eleven trials compared different oral antibiotics.\nWe are uncertain as to whether cefadroxil compared to flucloxacillin (17/21 versus 18/20, risk ratio (RR) 0.90, 95% confidence interval (CI) 0.70 to 1.16; 41 participants; 1 study; 10 days of treatment) or azithromycin compared to cefaclor (8/15 versus 10/16, RR 1.01, 95% CI 0.72 to 1.40; 31 participants; 2 studies; 7 days of treatment) differed in clinical cure (both very low-certainty evidence). There may be little to no difference in clinical cure rate between cefdinir and cefalexin after 17 to 24 days (25/32 versus 32/42, RR 1.00, 95% CI 0.73 to 1.38; 74 participants; 1 study; low-certainty evidence), and there probably is little to no difference in clinical cure rate between cefditoren pivoxil and cefaclor after 7 days (24/46 versus 21/47, RR 1.17, 95% CI 0.77 to 1.78; 93 participants; 1 study; moderate-certainty evidence).\nFor risk of severe adverse events leading to treatment withdrawal, there may be little to no difference between cefdinir versus cefalexin after 17 to 24 days (1/191 versus 1/200, RR 1.05, 95% CI 0.07 to 16.62; 391 participants; 1 study; low-certainty evidence). There may be an increased risk with cefadroxil compared with flucloxacillin after 10 days (6/327 versus 2/324, RR 2.97, 95% CI 0.60 to 14.62; 651 participants; 1 study; low-certainty evidence) and cefditoren pivoxil compared with cefaclor after 7 days (2/77 versus 0/73, RR 4.74, 95% CI 0.23 to 97.17; 150 participants; 1 study; low-certainty evidence). However, for these three comparisons the 95% CI is very wide and includes the possibility of both increased and reduced risk of events. We are uncertain whether azithromycin affects the risk of severe adverse events leading to withdrawal of treatment compared to cefaclor (274 participants; 2 studies; very low-certainty evidence) as no events occurred in either group after seven days.\nFor risk of minor adverse events, there is probably little to no difference between the following comparisons: cefadroxil versus flucloxacillin after 10 days (91/327 versus 116/324, RR 0.78, 95% CI 0.62 to 0.98; 651 participants; 1 study; moderate-certainty evidence) or cefditoren pivoxil versus cefaclor after 7 days (8/77 versus 5/73, RR 1.52, 95% CI 0.52 to 4.42; 150 participants; 1 study; moderate-certainty evidence). We are uncertain of the effect of azithromycin versus cefaclor after seven days due to very low-certainty evidence (7/148 versus 4/126, RR 1.26, 95% CI 0.38 to 4.17; 274 participants; 2 studies). The study comparing cefdinir versus cefalexin did not report data for total minor adverse events, but both groups experienced diarrhoea, nausea, and vaginal mycosis during 17 to 24 days of treatment. Additional adverse events reported in the other included studies were vomiting, rashes, and gastrointestinal symptoms such as stomach ache, with some events leading to study withdrawal.\nThree included studies assessed recurrence following completion of treatment, none of which evaluated our key comparisons, and no studies assessed quality of life.\nAuthors' conclusions\nWe found no RCTs regarding the efficacy and safety of topical antibiotics versus antiseptics, topical versus systemic antibiotics, or phototherapy versus sham light for treating bacterial folliculitis or boils. Comparative trials have not identified important differences in efficacy or safety outcomes between different oral antibiotics for treating bacterial folliculitis or boils.\nMost of the included studies assessed participants with skin and soft tissue infection which included many disease types, whilst others focused specifically on folliculitis or boils. Antibiotic sensitivity data for causative organisms were often not reported. Future trials should incorporate culture and sensitivity information and consider comparing topical antibiotic with antiseptic, and topical versus systemic antibiotics or phototherapy.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "First, we searched for randomised controlled studies, in which people were randomly put into one of two or more treatment groups. This makes it less likely that any differences between treatments were actually due to differences in the people who received them (rather than the treatments themselves, which is what we wanted to find out).\nWe then compared the results, and summarised the evidence from all the studies. Finally, we rated our confidence in the evidence, based on factors such as study methods and sizes, and the consistency of findings across studies."
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"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 1999. Corticosteroids are widely used in inflammatory conditions as an immunosuppressive agent. Bone loss is a serious side effect of this therapy. Several studies have examined the use of bisphosphonates in the prevention and treatment of glucocorticosteroid-induced osteoporosis (GIOP) and have reported varying magnitudes of effect.\nObjectives\nTo assess the benefits and harms of bisphosphonates for the prevention and treatment of GIOP in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE and Embase up to April 2016 and International Pharmaceutical Abstracts (IPA) via OVID up to January 2012 for relevant articles and conference proceedings with no language restrictions. We searched two clinical trial registries for ongoing and recently completed studies (ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal). We also reviewed reference lists of relevant review articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) satisfying the following criteria: 1) prevention or treatment of GIOP; 2) adults taking a mean steroid dose of 5.0 mg/day or more; 3) active treatment including bisphosphonates of any type alone or in combination with calcium or vitamin D; 4) comparator treatment including a control of calcium or vitamin D, or both, alone or with placebo; and 4) reporting relevant outcomes. We excluded trials that included people with transplant-associated steroid use.\nData collection and analysis\nAt least two review authors independently selected trials for inclusion, extracted data, performed ‘risk of bias’ assessment and evaluated the certainty of evidence using the GRADE approach. Major outcomes of interest were the incidence of vertebral and nonvertebral fractures after 12 to 24 months; the change in bone mineral density (BMD) at the lumbar spine and femoral neck after 12 months; serious adverse events; withdrawals due to adverse events; and quality of life. We used standard Cochrane methodological procedures.\nMain results\nWe included a total of 27 RCTs with 3075 participants in the review. Pooled analysis for incident vertebral fractures included 12 trials (1343 participants) with high-certainty evidence and low risk of bias. In this analysis 46/597 (or 77 per 1000) people experienced new vertebral fractures in the control group compared with 31/746 (or 44 per 1000; range 27 to 70) in the bisphosphonate group; relative improvement of 43% (9% to 65% better) with bisphosphonates; absolute increased benefit of 2% fewer people sustaining fractures with bisphosphonates (5% fewer to 1% more); number needed to treat for an additional beneficial outcome (NNTB) was 31 (20 to 145) meaning that approximately 31 people would need to be treated with bisphosphonates to prevent new vertebral fractures in one person.\nPooled analysis for incident nonvertebral fractures included nine trials with 1245 participants with low-certainty evidence (downgraded for imprecision and serious risk of bias as a patient-reported outcome). In this analysis 30/546 (or 55 per 1000) people experienced new nonvertebral fracture in the control group compared with 29/699 (or 42 per 1000; range 25 to 69) in the bisphosphonate group; relative improvement of 21% with bisphosphonates (33% worse to 53% better); absolute increased benefit of 1% fewer people with fractures with bisphosphonates (4% fewer to 1% more).\nPooled analysis on BMD change at the lumbar spine after 12 months included 23 trials with 2042 patients. Eighteen trials with 1665 participants were included in the pooled analysis on BMD at the femoral neck after 12 months. Evidence for both outcomes was moderate-certainty (downgraded for indirectness as a surrogate marker for osteoporosis) with low risk of bias. Overall, the bisphosphonate groups reported stabilisation or increase in BMD, while the control groups showed decreased BMD over the study period. At the lumbar spine, there was an absolute increase in BMD of 3.5% with bisphosphonates (2.90% to 4.10% higher) with a relative improvement of 1.10% with bisphosphonates (0.91% to 1.29%); NNTB 3 (2 to 3). At the femoral neck, the absolute difference in BMD was 2.06% higher in the bisphosphonate group compared to the control group (1.45% to 2.68% higher) with a relative improvement of 1.29% (0.91% to 1.69%); NNTB 5 (4 to 7).\nPooled analysis on serious adverse events included 15 trials (1703 participants) with low-certainty evidence (downgraded for imprecision and risk of bias). In this analysis 131/811 (or 162 per 1000) people experienced serious adverse events in the control group compared to 136/892 (or 147 per 1000; range 120 to 181) in the bisphosphonate group; absolute increased harm of 0% more serious adverse events (2% fewer to 2% more); a relative per cent change with 9% improvement (12% worse to 26% better).\nPooled analysis for withdrawals due to adverse events included 15 trials (1790 patients) with low-certainty evidence (downgraded for imprecision and risk of bias). In this analysis 63/866 (or 73 per 1000) people withdrew in the control group compared to 76/924 (or 77 per 1000; range 56 to 107) in the bisphosphonate group; an absolute increased harm of 1% more withdrawals with bisphosphonates (95% CI 1% fewer to 3% more); a relative per cent change 6% worse (95% CI 47% worse to 23% better).\nQuality of life was not assessed in any of the trials.\nAuthors' conclusions\nThere was high-certainty evidence that bisphosphonates are beneficial in reducing the risk of vertebral fractures with data extending to 24 months of use. There was low-certainty evidence that bisphosphonates may make little or no difference in preventing nonvertebral fractures. There was moderate-certainty evidence that bisphosphonates are beneficial in preventing and treating corticosteroid-induced bone loss at both the lumbar spine and femoral neck. Regarding harm, there was low-certainty evidence that bisphosphonates may make little or no difference in the occurrence of serious adverse events or withdrawals due to adverse events. We are cautious in interpreting these data as markers for harm and tolerability due to the potential for bias.\nOverall, our review supports the use of bisphosphonates to reduce the risk of vertebral fractures and the prevention and treatment of steroid-induced bone loss.\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": "Steroids (glucocorticosteroids) are widely used to treat inflammation. Bone loss (osteoporosis) and spinal fractures are serious side effects of this therapy. Bisphosphonates are considered a first-line treatment for osteoporosis and have been used since the 1990s."
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"role": "user",
"content": "Abstract: Background\nProlonging kidney transplant survival is an important clinical priority. Induction immunosuppression with antibody therapy is recommended at transplantation and non-depleting interleukin-2 receptor monoclonal antibodies (IL2Ra) are considered first line. It is suggested that recipients at high risk of rejection should receive lymphocyte-depleting antibodies but the relative benefits and harms of the available agents are uncertain.\nObjectives\nWe aimed to: evaluate the relative and absolute effects of different antibody preparations (except IL2Ra) when used as induction therapy in kidney transplant recipients; determine how the benefits and adverse events vary for each antibody preparation; determine how the benefits and harms vary for different formulations of antibody preparation; and determine whether the benefits and harms vary in specific subgroups of recipients (e.g. children and sensitised recipients).\nSearch methods\nWe searched the Cochrane Kidney and Transplant's Specialised Register to 29 August 2016 through contact with the Information Specialist using search terms relevant to this review.\nSelection criteria\nRandomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant.\nData collection and analysis\nTwo authors independently extracted data and assessed risk of bias. Dichotomous outcomes are reported as relative risk (RR) and continuous outcomes as mean difference (MD) together with their 95% confidence intervals (CI).\nMain results\nWe included 99 studies (269 records; 8956 participants; 33 with contemporary agents). Methodology was incompletely reported in most studies leading to lower confidence in the treatment estimates.\nAntithymocyte globulin (ATG) prevented acute graft rejection (17 studies: RR 0.63, 95% CI 0.51 to 0.78). The benefits of ATG on graft rejection were similar when used with (12 studies: RR 0.61, 0.49 to 0.76) or without (5 studies: RR 0.65, 0.43 to 0.98) calcineurin inhibitor (CNI) treatment. ATG (with CNI therapy) had uncertain effects on death (3 to 6 months, 3 studies: RR 0.41, 0.13 to 1.22; 1 to 2 years, 5 studies: RR 0.75, 0.27 to 2.06; 5 years, 2 studies: RR 0.94, 0.11 to 7.81) and graft loss (3 to 6 months, 4 studies: RR 0.60, 0.34 to 1.05; 1 to 2 years, 3 studies: RR 0.65, 0.36 to 1.19). The effect of ATG on death-censored graft loss was uncertain at 1 to 2 years and 5 years. In non-CNI studies, ATG had uncertain effects on death but reduced death-censored graft loss (6 studies: RR 0.55, 0.38 to 0.78). When CNI and older non-CNI studies were combined, a benefit was seen with ATG at 1 to 2 years for both all-cause graft loss (7 studies: RR 0.71, 0.53 to 0.95) and death-censored graft loss (8 studies: RR 0.55, 0.39 to 0.77) but not sustained longer term. ATG increased cytomegalovirus (CMV) infection (6 studies: RR 1.55, 1.24 to 1.95), leucopenia (4 studies: RR 3.86, 2.79 to 5.34) and thrombocytopenia (4 studies: RR 2.41, 1.61 to 3.61) but had uncertain effects on delayed graft function, malignancy, post-transplant lymphoproliferative disorder (PTLD), and new onset diabetes after transplantation (NODAT).\nAlemtuzumab was compared to ATG in six studies (446 patients) with early steroid withdrawal (ESW) or steroid minimisation. Alemtuzumab plus steroid minimisation reduced acute rejection compared to ATG at one year (4 studies: RR 0.57, 0.35 to 0.93). In the two studies with ESW only in the alemtuzumab arm, the effect of alemtuzumab on acute rejection at 1 year was uncertain compared to ATG (RR 1.27, 0.50 to 3.19). Alemtuzumab had uncertain effects on death (1 year, 2 studies: RR 0.39, 0.06 to 2.42; 2 to 3 years, 3 studies: RR 0.67, 95% CI 0.15 to 2.95), graft loss (1 year, 2 studies: RR 0.39, 0.13 to 1.30; 2 to 3 years, 3 studies: RR 0.98, 95% CI 0.47 to 2.06), and death-censored graft loss (1 year, 2 studies: RR 0.38, 0.08 to 1.81; 2 to 3 years, 3 studies: RR 2.45, 95% CI 0.67 to 8.97) compared to ATG. Creatinine clearance was lower with alemtuzumab plus ESW at 6 months (2 studies: MD -13.35 mL/min, -23.91 to -2.80) and 2 years (2 studies: MD -12.86 mL/min, -23.73 to -2.00) compared to ATG plus triple maintenance. Across all 6 studies, the effect of alemtuzumab versus ATG was uncertain on all-cause infection, CMV infection, BK virus infection, malignancy, and PTLD. The effect of alemtuzumab with steroid minimisation on NODAT was uncertain, compared to ATG with steroid maintenance.\nAlemtuzumab plus ESW compared with triple maintenance without induction therapy had uncertain effects on death and all-cause graft loss at 1 year, acute rejection at 6 months and 1 year. CMV infection was increased (2 studies: RR 2.28, 1.18 to 4.40). Treatment effects were uncertain for NODAT, thrombocytopenia, and malignancy or PTLD.\nRituximab had uncertain effects on death, graft loss, acute rejection and all other adverse outcomes compared to placebo.\nAuthors' conclusions\nATG reduces acute rejection but has uncertain effects on death, graft survival, malignancy and NODAT, and increases CMV infection, thrombocytopenia and leucopenia. Given a 45% acute rejection risk without ATG induction, seven patients would need treatment to prevent one having rejection, while incurring an additional patient experiencing CMV disease for every 12 treated. Excluding non-CNI studies, the risk of rejection was 37% without induction with six patients needing treatment to prevent one having rejection.\nIn the context of steroid minimisation, alemtuzumab prevents acute rejection at 1 year compared to ATG. Eleven patients would require treatment with alemtuzumab to prevent 1 having rejection, assuming a 21% rejection risk with ATG.\nTriple maintenance without induction therapy compared to alemtuzumab combined with ESW had similar rates of acute rejection but adverse effects including NODAT were poorly documented. Alemtuzumab plus steroid withdrawal would cause one additional patient experiencing CMV disease for every six patients treated compared to no induction and triple maintenance, in the absence of any clinical benefit. Overall, ATG and alemtuzumab decrease acute rejection at a cost of increased CMV disease while patient-centred outcomes (reduced death or lower toxicity) do not appear to be improved.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "A kidney transplant is the best treatment for many people who have severe kidney disease to allow patients to return to work and feel better. Patients who receive a kidney transplant receive drugs to prevent their own body from rejecting the transplant - the aim of treatment is to prolong the function of the kidney transplant while minimising common long-term side effects of treatment such as cancer, infection, and diabetes. For some patients who have a much higher risk of rejection, additional treatment is given at the time of the operation (which may lower the body's ability to attack the kidney transplant and increase kidney function but can increase the risk of complications such as infection and cancer)."
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"content": "Abstract: Background\nAtherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear.\nObjectives\nTo assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD).\nSearch methods\nThe Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies.\nSelection criteria\nWe included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI).\nData collection and analysis\nTwo review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements.\nMain results\nEleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years.\nThere were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months.\nAuthors' conclusions\nBased on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.\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": "All the trials had differences in the way in which they inserted the balloons, and in the type and duration of additional antiplatelet (anticlotting) therapy, leading to downgrading of the quality of the evidence. The quality of the evidence presented was moderate for target lesion revascularization and change in Rutherford category (a way of classifying PAD), and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (which is used to predict the severity of PAD)."
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query-laysum | 3129 | [
{
"role": "user",
"content": "Abstract: Background\nDelayed recovery of urinary continence is a major adverse effect of robotic-assisted laparoscopic prostatectomy (RALP) in men undergoing prostate cancer treatment. To address this issue, a number of surgical techniques have been designed to reconstruct the posterior aspect of the rhabdosphincter, which is responsible for urinary continence after removal of the prostate; however, it is unclear how well they work.\nObjectives\nTo assess the effects of posterior musculofascial reconstruction RALP compared to no posterior reconstruction during RALP for the treatment of clinically localized prostate cancer.\nSearch methods\nWe performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to 12 March 2021. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which participants were randomized to undergo variations of posterior musculofascial reconstruction RALP versus no posterior reconstruction during RALP for clinically localized prostate cancer.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery at six and twelve months after surgery, potency recovery twelve months after surgery, positive surgical margins (PSM), and biochemical recurrence-free survival (BCRFS). We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.\nMain results\nOur search identified 13 records of eight unique RCTs, of which six were published studies and two were abstract proceedings. We included 1085 randomized participants, of whom 963 completed the trials (88.8%). All participants had either cT1c or cT2 or cT3a disease, with a mean prostate-specific antigen level of 8.15 ng/mL.\nPrimary outcomes\nPosterior reconstruction RALP (PR-RALP) may improve urinary continence one week after catheter removal compared to no posterior reconstruction during RALP (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.90 to 1.73; I2 = 42%; studies = 5, participants = 498; low CoE) although the CI also includes the possibility of no effect. Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 84 more men per 1000 (33 fewer to 244 more) reporting urinary continence recovery.\nPosterior reconstruction may have little to no effect on urinary continence three months after surgery compared to no posterior reconstruction during RALP (RR 0.98, 95% CI 0.84 to 1.14; I2 = 67%; studies = 6, participants = 842; low CoE). Assuming 701 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 14 fewer men per 1000 (112 fewer to 98 more) reporting urinary continence after three months.\nPR-RALP probably results in little to no difference in serious adverse events compared to no posterior reconstruction during RALP (RR 0.75, 95% CI 0.29 to 1.92; I2 = 0%; studies = 6, participants = 835; moderate CoE). Assuming 25 per 1000 men undergoing standard RALP experience a serious adverse event at this time point, this corresponds to six fewer men per 1000 (17 fewer to 23 more) reporting serious adverse events.\nSecondary outcomes\nPR-RALP may result in little to no difference in recovery of continence 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.98 to 1.07; I2 = 25%; studies = 3, participants = 602; low CoE). Assuming 918 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 18 more men per 1000 (18 fewer to 64 more) reporting urinary continence recovery.\nWe are very uncertain about the effects of PR-RALP on recovery of potency 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.82 to 1.26; I2 = 3%; studies = 2, participants = 308; very low CoE). Assuming 433 per 1000 men undergoing standard RALP are potent at this time point, this corresponds to nine more men per 1000 (78 fewer to 113 more) reporting potency recovery.\nPR-RALP may result in little to no difference in positive surgical margins compared to no posterior reconstruction during RALP (RR 1.24, 95% CI 0.65 to 2.33; I2 = 50%; studies = 3, participants = 517; low CoE). Assuming 130 per 1000 men undergoing standard RALP have a positive surgical margin, this corresponds to 31 more men per 1000 (46 fewer to 173 more) reporting positive surgical margins.\nPR-RALP may result in little to no difference in biochemical recurrence compared to no posterior reconstruction during RALP (RR 1.36, 95% CI 0.74 to 2.52; I2 = 0%; studies = 2, participants = 468; low CoE). Assuming 70 per 1000 men undergoing standard RALP have experienced biochemical recurrence at this time point, this corresponds to 25 more men per 1000 (18 fewer to 107 more) reporting biochemical recurrence.\nAuthors' conclusions\nThis review found evidence that PR-RALP may improve early continence one week after catheter removal but not thereafter. Meanwhile, adverse event rates are probably not impacted and surgical margins rates are likely similar. This review was unable to determine if or how these findings may be impacted by the person's age, nerve-sparing status, or clinical stage. Study limitations, imprecision, and inconsistency lowered the certainty of evidence for the outcomes assessed.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found that posterior reconstruction RALP may result in better continence one week after the catheter comes out compared to standard RALP (although it is also possible that it is no better), but it may make little to no difference at either three or 12 months after surgery. Posterior reconstruction RALP probably results in little to no difference in serious unwanted effects compared with the standard way of doing the surgery. There may also be little to no difference in positive surgical margins, meaning the risk of there being cancer cells right at the cut edge of the prostate when viewed under the microscope. There may also be no difference between the two techniques in terms of the risk of a PSA level that goes up within 12 months of surgery, which often signals that there is cancer left behind. We are very uncertain how posterior reconstruction RALP effects the ability to achieve an erection, compared to standard RALP."
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query-laysum | 3130 | [
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"role": "user",
"content": "Abstract: Background\nPelvic, hip, and long bone fractures can result in significant bleeding at the time of injury, with further blood loss if they are treated with surgical fixation. People undergoing surgery are therefore at risk of requiring a blood transfusion and may be at risk of peri-operative anaemia. Pharmacological interventions for blood conservation may reduce the risk of requiring an allogeneic blood transfusion and associated complications.\nObjectives\nTo assess the effectiveness of different pharmacological interventions for reducing blood loss in definitive surgical fixation of the hip, pelvic, and long bones.\nSearch methods\nWe used a predefined search strategy to search CENTRAL, MEDLINE, PubMed, Embase, CINAHL, Transfusion Evidence Library, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) from inception to 7 April 2022, without restrictions on language, year, or publication status.\nWe handsearched reference lists of included trials to identify further relevant trials. We contacted authors of ongoing trials to acquire any unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) of people who underwent trauma (non-elective) surgery for definitive fixation of hip, pelvic, and long bone (pelvis, tibia, femur, humerus, radius, ulna and clavicle) fractures only. There were no restrictions on gender, ethnicity, or age.\nWe excluded planned (elective) procedures (e.g. scheduled total hip arthroplasty), and studies published since 2010 that had not been prospectively registered.\nEligible interventions included: antifibrinolytics (tranexamic acid, aprotinin, epsilon-aminocaproic acid), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants, and non-fibrin sealants.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE. We did not perform a network meta-analysis due to lack of data.\nMain results\nWe included 13 RCTs (929 participants), published between 2005 and 2021. Three trials did not report any of our predefined outcomes and so were not included in quantitative analyses (all were tranexamic acid versus placebo).\nWe identified three comparisons of interest: intravenous tranexamic acid versus placebo; topical tranexamic acid versus placebo; and recombinant factor VIIa versus placebo. We rated the certainty of evidence as very low to low across all outcomes.\nComparison 1. Intravenous tranexamic acid versus placebo\nIntravenous tranexamic acid compared to placebo may reduce the risk of requiring an allogeneic blood transfusion up to 30 days (RR 0.48, 95% CI 0.34 to 0.69; 6 RCTs, 457 participants; low-certainty evidence) and may result in little to no difference in all-cause mortality (Peto odds ratio (Peto OR) 0.38, 95% CI 0.05 to 2.77; 2 RCTs, 147 participants; low-certainty evidence).\nIt may result in little to no difference in risk of participants experiencing myocardial infarction (risk difference (RD) 0.00, 95% CI −0.03 to 0.03; 2 RCTs, 199 participants; low-certainty evidence), and cerebrovascular accident/stroke (RD 0.00, 95% CI −0.02 to 0.02; 3 RCTs, 324 participants; low-certainty evidence).\nWe are uncertain if there is a difference between groups for risk of deep vein thrombosis (Peto OR 2.15, 95% CI 0.22 to 21.35; 4 RCTs, 329 participants, very low-certainty evidence), pulmonary embolism (Peto OR 1.08, 95% CI 0.07 to 17.66; 4 RCTs, 329 participants; very low-certainty evidence), and suspected serious drug reactions (RD 0.00, 95% CI −0.03 to 0.03; 2 RCTs, 185 participants; very low-certainty evidence).\nNo data were available for number of red blood cell units transfused, reoperation, or acute transfusion reaction.\nWe downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures), and upgraded the evidence for transfusion requirement for a large effect.\nComparison 2. Topical tranexamic acid versus placebo\nWe are uncertain if there is a difference between topical tranexamic acid and placebo for risk of requiring an allogeneic blood transfusion (RR 0.31, 95% CI 0.08 to 1.22; 2 RCTs, 101 participants), all-cause mortality (RD 0.00, 95% CI −0.10 to 0.10; 1 RCT, 36 participants), risk of participants experiencing myocardial infarction (Peto OR 0.15, 95% CI 0.00 to 7.62; 1 RCT, 36 participants), cerebrovascular accident/stroke (RD 0.00, 95% CI −0.06 to 0.06; 1 RCT, 65 participants); and deep vein thrombosis (Peto OR 1.11, 95% CI 0.07 to 17.77; 2 RCTs, 101 participants).\nAll outcomes reported were very low-certainty evidence.\nNo data were available for number of red blood cell units transfused, reoperation, incidence of pulmonary embolism, acute transfusion reaction, or suspected serious drug reactions.\nWe downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), inconsistency (moderate heterogeneity), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures, and high risk of attrition and reporting biases in one trial).\nComparison 3. Recombinant factor VIIa versus placebo\nOnly one RCT of 48 participants reported data for recombinant factor VIIa versus placebo, so we have not presented the results here.\nAuthors' conclusions\nWe cannot draw conclusions from the current evidence due to lack of data. Most published studies included in our analyses assessed the use of tranexamic acid (compared to placebo, or using different routes of administration).\nWe identified 27 prospectively registered ongoing RCTs (total target recruitment of 4177 participants by end of 2023). The ongoing trials create six new comparisons: tranexamic acid (tablet + injection) versus placebo; intravenous tranexamic acid versus oral tranexamic acid; topical tranexamic acid versus oral tranexamic acid; different intravenous tranexamic acid dosing regimes; topical tranexamic acid versus topical fibrin glue; and fibrinogen (injection) versus placebo.\n\nGiven the provided abstract, please respond to the following query: \"Recombinant factor VIIa\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are uncertain if recombinant factor VIIa has any impact on the need for blood transfusion, the need for reoperation for bleeding, the risk of DVT, pulmonary embolism, or suspected serious reaction to the medicine. There was no evidence to assess whether it impacted deaths from any cause, the risk of heart attack, stroke, or immediate reaction to the medicine."
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query-laysum | 3131 | [
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"role": "user",
"content": "Abstract: Background\nAcute upper respiratory tract infections (URTIs), including the common cold and rhinosinusitis, are common afflictions that cause discomfort and debilitation and contribute significantly to workplace absenteeism. Treatment is generally by antipyretic and decongestant drugs and sometimes antibiotics, even though most infections are viral. Nasal irrigation with saline is often employed as an adjunct treatment for URTI symptoms despite a relative lack of evidence for benefit in this clinical setting. This review is an update of the Cochrane review by Kassel et al, which found that saline was probably effective in reducing the severity of some symptoms associated with acute URTIs.\nObjectives\nTo assess the effects of saline nasal irrigation for treating the symptoms of acute URTIs.\nSearch methods\nWe searched CENTRAL (2014, Issue 7), MEDLINE (1966 to July week 5, 2014), EMBASE (1974 to August 2014), CINAHL (1982 to August 2014), AMED (1985 to August 2014) and LILACS (1982 to August 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing topical nasal saline treatment to other interventions in adults and children with clinically diagnosed acute URTIs.\nData collection and analysis\nTwo review authors (DK, BM) independently assessed trial quality with the Cochrane 'Risk of bias' tool and extracted data. We analysed all data using the Cochrane Review Manager software. Due to the large variability of outcome measures only a small number of outcomes could be pooled for statistical analysis.\nMain results\nWe identified five RCTs that randomised 544 children (three studies) and 205 adults (exclusively from two studies). They all compared saline irrigation to routine care or other nose sprays, rather than placebo. We included two new trials in this update, which did not contribute data of sufficient size or quality to materially change the original findings. Most trials were small and we judged them to be of low quality, contributing to an unclear risk of bias. Most outcome measures differed greatly between included studies and therefore could not be pooled. Most results showed no difference between nasal saline treatment and control. However, one larger trial, conducted with children, did show a significant reduction in nasal secretion score (mean difference (MD) -0.31, 95% confidence interval (CI) -0.48 to -0.14) and nasal breathing (obstruction) score (MD -0.33, 95% CI -0.47 to -0.19) in the saline group. However, a MD of -0.33 on a four-point symptom scale may have minimal clinical significance. The trial also showed a significant reduction in the use of decongestant medication by the saline group. Minor nasal discomfort and/or irritation was the only side effect reported by a minority of participants.\nAuthors' conclusions\nNasal saline irrigation possibly has benefits for relieving the symptoms of acute URTIs. However, the included trials were generally too small and had a high risk of bias, reducing confidence in the evidence supporting this. Future trials should involve larger numbers of participants and report standardised and clinically meaningful outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "Acute upper respiratory tract infections (URTIs) include colds, influenza and infections of the throat, nose or sinuses. They are usually self limiting viral infections, though sometimes symptoms may persist for many weeks beyond the clearance of the initial infection, with or without establishment of secondary bacterial infections. The aim of treatment is predominantly for relief of symptoms, though some treatments may have a role in reducing the duration of post-viral symptoms, such as cough. Saline nose spray and larger volume nasal washes have become more popular as one of many treatment options for URTIs, and they have been shown to have some effectiveness for chronic sinusitis and following nasal surgery. However, little is known about their effectiveness in the treatment of acute URTI or which symptoms they may be effective for."
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query-laysum | 3132 | [
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"role": "user",
"content": "Abstract: Background\nHysteroscopy is increasingly performed in an outpatient setting. Pain is the primary reason for abandonment of procedure or incomplete assessment. There is no consensus upon routine use of analgesia during hysteroscopy.\nObjectives\nTo assess the effectiveness and safety of pharmacological interventions for pain relief in women undergoing outpatient hysteroscopy, compared with placebo, no treatment or other pharmacological therapies.\nSearch methods\nIn September 2016 we searched the Cochrane Gynaecology and Fertility (CGF) Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers (ClinicalTrials.gov and WHO ICTRP), together with reference checking and contact with study authors and experts.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing use of pharmacological interventions with other pharmacological interventions and pharmacological interventions versus placebo or no treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcome was mean pain score.\nMain results\nWe included 32 RCTS (3304 participants), of which only 19 reported data suitable for analysis. Most studies were at unclear or high risk of bias in most of the domains assessed. The evidence was low or very low quality, mainly due to risk of bias and imprecision. Baseline pain scores were relatively low in all groups.\nAnalgesic versus placebo or no treatment\nLocal anaesthetics\nLocal anaesthetics reduced mean pain scores during the procedure [(SMD) -0.29, 95% CI -0.39 to -0.19, 10 RCTs, 1496 women, I2 = 80%, low-quality evidence)] and within 30 minutes (SMD 0.50, 95% CI -0.67 to -0.33, 5 RCTs, 545 women, I2 = 43%, low-quality evidence). This translates to a difference of up to 7 mm on a 0-10 cm visual analogue scale (VAS) during the procedure and up to 13 mm within 30 minutes, which is unlikely to be clinically meaningful. There was no clear evidence of a difference between the groups in mean pain scores after > 30 minutes (SMD -0.11, 95% CI -0.30 to 0.07, 4 RCTs, 450 women, I2 = 0%, low-quality evidence), or in rates of vasovagal reactions (OR 0.70, 95% CI 0.43 to 1.13, 8 RCTs, 1309 women, I2 = 66%, very low-quality evidence). There was insufficient evidence to determine whether there was a difference in rates of non-pelvic pain (OR 1.76, 95% CI 0.53 to 5.80, 1 RCT, 99 women, very low-quality evidence).\nNonsteroidal anti-inflammatory drugs (NSAIDs)\nThere was insufficient evidence to determine whether there was a difference between the groups in mean pain scores during the procedure (SMD -0.18, 95% CI -0.35 to 0.00, 3 RCTs, 521 women, I2 = 81%, low-quality evidence). Pain scores were lower in the NSAIDs group within 30 minutes (SMD -0.25, 95% CI -0.46 to -0.04, 2 RCTs, 340 women, I2=29%, low-quality evidence) and at over 30 minutes (SMD -0.27, 95% CI -0.49 to -0.05, 2 RCTs, 321 women, I2 = 78%, low-quality evidence). This equates to maximum differences of under 7.5 mm on a 0-10 cm scale, which are unlikely to be clinically significant. One RCT (181 women) reported adverse events: there was insufficient evidence to determine whether there was a difference between the groups in vasovagal reactions (OR 0.76, 95% CI 0.20 to 2.94, very low-quality evidence). For other reported adverse events (non pelvic pain and allergic reactions) evidence was lacking.\nOpioids\nOne RCT utilised sublingual buprenorphine and one utilised oral tramadol. Data on pain scores during the procedure were unsuitable for pooling due to inconsistency. Tramadol was associated with a benefit of up to 22 mm on a 0-10 cm scale (SMD -0.76, 95% CI -1.10 to -0.42, 1 RCT, 140 women). However, the effect estimate for this outcome for sublingual opioids did not support a benefit from the intervention (SMD 0.08, 95% CI -0.22 to 0.39, 164 women). Compared with placebo, the pain score within 30 minutes of the procedure was reduced in the tramadol group, with a difference of up to 17mm on a 0-10cm scale (SMD -0.57, 95% CI -0.91 to -0.23 , 1 RCT, 140 women, low-quality evidence. There was no clear evidence of a difference between the tramadol and placebo groups at over 30 minutes (SMD -0.17, 95% CI -0.51 to 0.16, 1 RCT, 140 women, low-quality evidence). Nausea and vomiting occurred in 39% of the buprenorphine group, and in none of the placebo group (OR 107.55, 95% CI 6.44 to 1796.46)\nAnalgesic versus any other analgesic\nSome comparisons did not report pain scores at all time frames of interest, and none reported data on adverse events.\nOne RCT (84 women) compared local intracervical anaesthesia versus combined intracervical and paracervical anaesthesia. Pain scores were higher in the group with local intracervical anaesthesia during the procedure (SMD 4.27, 95% CI 3.49 to 5.06, very low-quality evidence), within 30 minutes (SMD 1.55, 95% CI 1.06 to 2.05, very low-quality evidence) and at more than 30 minutes (SMD 3.47, 95% CI 2.78 to 4.15, very low-quality evidence). This translates to a possible benefit in the combined group of up to 12 mm on a 0-10 cm scale during the procedure. Benefits at longer follow-up were smaller.\nOne RCT compared antispasmodic + NSAID versus local paracervical anaesthesia. Pain scores were lower in the NSAID group than in the local anaesthesia group (during procedure: SMD -1.40, 95% CI -1.90 to -0.91; >30 minutes after procedure: SMD -0.87, 95% CI -1.33 to -0.41; 80 women, very low-quality evidence). This suggests a possible benefit of during the procedure of up to 23 mm on a 0-10 VAS scale and up to 11 mm >30 minutes after the procedure.\nOther comparisons included local intracervical anaesthesia versus combined intracervical, paracervical and topical anaesthesia, and opioid versus NSAIDs. Findings were inconclusive.\nAuthors' conclusions\nThere was no consistent good-quality evidence of a clinically meaningful difference in safety or effectiveness between different types of pain relief compared with each other or with placebo or no treatment in women undergoing outpatient hysteroscopy.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": ""
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query-laysum | 3133 | [
{
"role": "user",
"content": "Abstract: Background\nCaring for people with dementia is highly challenging, and family carers are recognised as being at increased risk of physical and mental ill-health. Most current interventions have limited success in reducing stress among carers of people with dementia. Mindfulness-based stress reduction (MBSR) draws on a range of practices and may be a promising approach to helping carers of people with dementia.\nObjectives\nTo assess the effectiveness of MBSR in reducing the stress of family carers of people with dementia.\nSearch methods\nWe searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (all years to Issue 9 of 12, 2017), MEDLINE (Ovid SP 1950 to September 2017), Embase (Ovid SP 1974 to Sepetmber 2017), Web of Science (ISI Web of Science 1945 to September 2017), PsycINFO (Ovid SP 1806 to September 2017), CINAHL (all dates to September 2017), LILACS (all dates to September 2017), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Dissertation Abstracts International (DAI) up to 6 September 2017, with no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of MBSR for family carers of people with dementia.\nData collection and analysis\nTwo review authors independently screened references for inclusion criteria, extracted data, assessed the risk of bias of trials with the Cochrane 'Risk of bias' tool, and evaluated the quality of the evidence using the GRADE instrument. We contacted study authors for additional information, then conducted meta-analyses, or reported results narratively in the case of insufficient data. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included five RCTs involving 201 carers assessing the effectiveness of MBSR. Controls used in included studies varied in structure and content. Mindfulness-based stress reduction programmes were compared with either active controls (those matched for time and attention with MBSR, i.e. education, social support, or progressive muscle relaxation), or inactive controls (those not matched for time and attention with MBSR, i.e. self help education or respite care). One trial used both active and inactive comparisons with MBSR. All studies were at high risk of bias in terms of blinding of outcome assessment. Most studies provided no information about selective reporting, incomplete outcome data, or allocation concealment.\n1. Compared with active controls, MBSR may reduce depressive symptoms of carers at the end of the intervention (3 trials, 135 participants; standardised mean difference (SMD) -0.63, 95% confidence interval (CI) -0.98 to -0.28; P<0.001; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).\nMindfulness-based stress reduction compared with active control may decrease carer anxiety at the end of the intervention (1 trial, 78 participants; mean difference (MD) -7.50, 95% CI -13.11 to -1.89; P<0.001; low-quality evidence) and may slightly increase carer burden (3 trials, 135 participants; SMD 0.24, 95% CI -0.11 to 0.58; P=0.18; low-quality evidence), although both results were imprecise, and we could not exclude little or no effect. Due to the very low quality of the evidence, we could not be sure of any effect on carers' coping style, nor could we determine whether carers were more or less likely to drop out of treatment.\n2. Compared with inactive controls, MBSR showed no clear evidence of any effect on depressive symptoms (2 trials, 50 participants; MD -1.97, 95% CI -6.89 to 2.95; P=0.43; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).\nIn this comparison, MBSR may also reduce carer anxiety at the end of the intervention (1 trial, 33 participants; MD -7.27, 95% CI -14.92 to 0.38; P=0.06; low-quality evidence), although we were unable to exclude little or no effect. Due to the very low quality of the evidence, we could not be certain of any effects of MBSR on carer burden, the use of positive coping strategies, or dropout rates.\nWe found no studies that looked at quality of life of carers or care-recipients, or institutionalisation.\nOnly one included study reported on adverse events, noting a single adverse event related to yoga practices at home\nAuthors' conclusions\nAfter accounting for non-specific effects of the intervention (i.e. comparing it with an active control), low-quality evidence suggests that MBSR may reduce carers' depressive symptoms and anxiety, at least in the short term.\nThere are significant limitations to the evidence base on MBSR in this population. Our GRADE assessment of the evidence was low to very low quality. We downgraded the quality of the evidence primarily because of high risk of detection or performance bias, and imprecision.\nIn conclusion, MBSR has the potential to meet some important needs of the carer, but more high-quality studies in this field are needed to confirm its efficacy.\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 considered the quality of the evidence to be low or very low, mainly because the studies were small and the way they were designed or conducted put them at risk of giving biased results. Consequently, we have limited confidence in the results."
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query-laysum | 3134 | [
{
"role": "user",
"content": "Abstract: Background\nParenteral fluids are commonly used in people with acute stroke with poor oral fluid intake. However, the balance between benefit and harm for different fluid regimens is unclear.\nObjectives\nTo assess whether different parenteral fluid regimens lead to differences in death, or death or dependence, after stroke based on fluid type, fluid volume, duration of fluid administration, and mode of delivery.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) (Cochrane Library 2015, Issue 5), MEDLINE (2008 to May 2015), EMBASE (2008 to May 2015), and CINAHL (1982 to May 2015). We also searched ongoing trials registers (May 2015) and reference lists, performed cited reference searches, and contacted authors.\nSelection criteria\nRandomised trials of parenteral fluid regimens in adults with ischaemic or haemorrhagic stroke within seven days of stroke onset that reported death or dependence.\nData collection and analysis\nOne review author screened titles and abstracts. We obtained the full-text articles of relevant studies, and two review authors independently selected trials for inclusion and extracted data. We used Cochrane's tool for bias assessment.\nMain results\nWe included 12 studies (2351 participants: range 27 to 841).\nCharacteristics: The 12 included studies compared hypertonic (colloids) with isotonic fluids (crystalloids); of these, five studies (1420 participants) also compared 0.9% saline with another fluid. No data were available to make other comparisons. Delay from stroke to recruitment varied from less than 24 hours to 72 hours. Duration of fluid delivery was between two hours and 10 days.\nBias assessment: Investigators and participants in eight of the 12 included studies were blind to treatment allocation, seven of the 12 included studies gave details of randomisation, and eight of the 12 included studies reported all outcomes measured.\nResults: There were no relevant completed trials that addressed the effect of volume, duration, or mode of fluid delivery on death or dependence in people with stroke.\nThe odds of death or dependence were similar in participants allocated to colloids or crystalloid fluid regimens (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.79 to 1.21, five studies, I² = 58%, low-quality evidence), and between 0.9% saline or other fluid regimens (OR 1.04, 95% CI 0.82 to 1.32, three studies, I² = 71%, low-quality evidence). There was substantial heterogeneity in these estimates.\nThe odds of death were similar between colloids and crystalloids (OR 1.02, 95% CI 0.82 to 1.27, 12 studies, I² = 24%, moderate-quality evidence), and 0.9% saline and other fluids (OR 0.87, 95% CI 0.67 to 1.12, five studies, I² = 53%, low-quality evidence). The odds of pulmonary oedema were higher in participants allocated to colloids (OR 2.34, 95% CI 1.28 to 4.29, I² = 0%). Although the studies observed a higher risk of cerebral oedema (OR 0.20, 95% CI 0.02 to 1.74) and pneumonia (OR 0.58, 95% CI 0.17 to 2.01) with crystalloids, we could not exclude clinically important benefits or harms.\nAuthors' conclusions\nWe found no evidence that colloids were associated with lower odds of death or dependence in the medium term after stroke compared with crystalloids, though colloids were associated with greater odds of pulmonary oedema. We found no evidence to guide the best volume, duration, or mode of parenteral fluid delivery for people with acute stroke.\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": "Fluids given into a vein (intravenous, or iv) or under the skin (subcutaneous) are commonly used in people with stroke, but there are no clear guidelines on the best fluid management in such cases. There are a number of possible different types of fluid that can be used: isotonic fluids, or crystalloids are solutions that contain similar amounts of dissolved salts as in normal cells and blood, whilst hypertonic fluids, or colloids usually contain more (or larger) dissolved particles than in normal cells and blood. Fluid can also be given in different volumes, or for different durations. Hence, we searched the available literature to find answers to these questions."
}
]
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query-laysum | 3135 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with chronic obstructive pulmonary disease (COPD) often experience difficulty with performing upper limb exercise due to dyspnoea and arm fatigue. Consequently, upper limb exercise training is typically incorporated in pulmonary rehabilitation programmes to improve upper limb exercise capacity; however, the effects of this training on dyspnoea and health-related quality of life (HRQoL) remain unclear.\nObjectives\nTo determine the effects of upper limb training (endurance or resistance training, or both) on symptoms of dyspnoea and HRQoL in people with COPD.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of trials, ClinicalTrials.gov and the World Health Organization trials portal from inception to 28 September 2016 as well as checking all reference lists of primary studies and review articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which upper limb exercise training of at least four weeks' duration was performed. Three comparisons were structured as: a) upper limb training only versus no training or sham intervention; b) combined upper limb training and lower limb training versus lower limb training alone; and c) upper limb training versus another type of upper limb training.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted outcome data and assessed risk of bias. We contacted study authors to provide missing data. We determined the treatment effect from each study as the post-treatment scores. We were able to analyse data for all three planned comparisons. For the upper limb training only versus no training or sham intervention structure, the upper limb training was further classified as 'endurance training' or 'resistance training' to determine the impact of training modality.\nMain results\nFifteen studies on 425 participants were included in the review, one of which was in abstract form only. Twelve studies were included in the meta-analysis across one or more of the three comparisons. The sample size of the included studies was small (12 to 43 participants) and overall study quality was moderate to low given the imprecision and risk of bias issues (i.e. missing information on sequence generation and allocation concealment as well as no blinding of outcome assessment and incomplete data).\nWhen upper limb training was compared to either no training or sham training, there was a small significant improvement in symptoms of dyspnoea with a mean difference (MD) of 0.37 points (95% confidence interval (CI) 0.02 to 0.72 points; data from four studies on 129 people). However, there was no significant improvement in dyspnoea when the studies of endurance training only (MD 0.41 points, 95% CI −0.13 to 0.95 points; data from two studies on 55 people) or resistance training only (MD 0.34 points, 95% CI −0.11 to 0.80 points; data from two studies on 74 people) were analysed. When upper limb training combined with lower limb training was compared to lower limb training alone, no significant difference in dyspnoea was shown (MD 0.36 points, 95% CI −0.04 to 0.76 points; data from three studies on 86 people). There were no studies which examined the effects on dyspnoea of upper limb training compared to another upper limb training intervention.\nThere was no significant improvement in HRQoL when upper limb training was compared to either no training or sham training with a standardised mean difference (SMD) of 0.05 (95% CI −0.31 to 0.40; four studies on 126 people) or when upper limb training combined with lower limb training was compared to lower limb training alone (SMD 0.01, 95% CI −0.40 to 0.43; three studies on 95 people). Only one study, in which endurance upper limb training was compared to resistance upper limb training, reported on HRQoL and showed no between-group differences (St George's Respiratory Questionnaire MD 2.0 points, 95% CI −9 to 12; one study on 20 people).\nPositive findings were shown for the effects of upper limb training on the secondary outcome of unsupported endurance upper limb exercise capacity. When upper limb training was compared to either no training or sham training, there was a large significant improvement in unsupported endurance upper limb capacity (SMD 0.66, 95% CI 0.19 to 1.13; six studies on 142 people) which remained significant when the studies in this analysis of endurance training only were examined (SMD 0.99, 95% CI 0.32 to 1.66; four studies on 85 people) but not when the studies of resistance training only were examined (SMD 0.23, 95% CI −0.31 to 0.76; three studies on 57 people, P = 0.08 for test of subgroup differences). When upper limb training combined with lower limb training was compared to lower limb training alone, there was also a large significant improvement in unsupported endurance upper limb capacity (SMD 0.90, 95% CI 0.12 to 1.68; three studies on 87 people). A single study compared endurance upper limb training to resistance upper limb training with a significant improvement in the number of lifts performed in one minute favouring endurance upper limb training (MD 6.0 lifts, 95% CI 0.29 to 11.71 lifts; one study on 17 people).\nAvailable data were insufficient to examine the impact of disease severity on any outcome.\nAuthors' conclusions\nEvidence from this review indicates that some form of upper limb exercise training when compared to no upper limb training or a sham intervention improves dyspnoea but not HRQoL in people with COPD. The limited number of studies comparing different upper limb training interventions precludes conclusions being made about the optimal upper limb training programme for people with COPD, although endurance upper limb training using unsupported upper limb exercises does have a large effect on unsupported endurance upper limb capacity. Future RCTs require larger participant numbers to compare the differences between endurance upper limb training, resistance upper limb training, and combining endurance and resistance upper limb training on patient-relevant outcomes such as dyspnoea, HRQoL and arm activity levels.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "some form of arm training can provide a small improvement to breathlessness but does not improve the quality of life of people with COPD. More specifically, endurance arm training can increase the capacity of the arms to move light weights in people with COPD."
}
]
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