dataset
stringclasses 1
value | id
stringlengths 1
5
| messages
listlengths 2
2
|
|---|---|---|
query-laysum | 4045 | [
{
"role": "user",
"content": "Abstract: Background\nThis review supersedes the original Cochrane review first published in 2008 (Huertas-Ceballos 2008).\nBetween 4% and 25% of school-aged children complain of recurrent abdominal pain (RAP) severe enough to interfere with their daily activities. No organic cause for this pain can be found on physical examination or investigation for the majority of such children. Although many children are managed by reassurance and simple measures, a large range of psychosocial interventions involving cognitive and behavioural components have been recommended.\nObjectives\nTo determine the effectiveness of psychosocial interventions for reducing pain in school-aged children with RAP.\nSearch methods\nIn June 2016 we searched CENTRAL, MEDLINE, Embase, eight other databases, and two trials registers. We also searched the references of identified studies and relevant reviews.\nSelection criteria\nRandomised controlled trials comparing psychosocial therapies with usual care, active control, or wait-list control for children and adolescents (aged 5 to 18 years) with RAP or an abdominal pain-related functional gastrointestinal disorder defined by the Rome III criteria were eligible for inclusion.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Five review authors independently selected studies, assessed them for risk of bias, and extracted relevant data. We also assessed the quality of the evidence using the GRADE approach.\nMain results\nThis review includes 18 randomised controlled trials (14 new to this version), reported in 26 papers, involving 928 children and adolescents with RAP between the ages of 6 and 18 years. The interventions were classified into four types of psychosocial therapy: cognitive behavioural therapy (CBT), hypnotherapy (including guided imagery), yoga, and written self-disclosure. The studies were carried out in the USA, Australia, Canada, the Netherlands, Germany, and Brazil. The majority of the studies were small and short term; only two studies included more than 100 participants, and only five studies had follow-up assessments beyond six months. Small sample sizes and the degree of assessed risk of performance and detection bias in many studies led to the overall quality of the evidence being rated as low to very low for all outcomes.\nFor CBT compared to control, we found evidence of treatment success postintervention (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.18 to 27.32; Z = 2.16; P = 0.03; 4 studies; 175 children; very low-quality evidence), but no evidence of treatment success at medium-term follow-up (OR 3.08, 95% CI 0.93 to 10.16; Z = 1.85; P = 0.06; 3 studies; 139 children; low-quality evidence) or long-term follow-up (OR 1.29, 95% CI 0.50 to 3.33; Z = 0.53; P = 0.60; 2 studies; 120 children; low-quality evidence). We found no evidence of effects of intervention on pain intensity scores measured postintervention (standardised mean difference (SMD) -0.33, 95% CI -0.74 to 0.08; 7 studies; 405 children; low-quality evidence), or at medium-term follow-up (SMD -0.32, 95% CI -0.85 to 0.20; 4 studies; 301 children; low-quality evidence).\nFor hypnotherapy (including studies of guided imagery) compared to control, we found evidence of greater treatment success postintervention (OR 6.78, 95% CI 2.41 to 19.07; Z = 3.63; P = 0.0003; 4 studies; 146 children; low-quality evidence) as well as reductions in pain intensity (SMD -1.01, 95% CI -1.41 to -0.61; Z = 4.97; P < 0.00001; 4 studies; 146 children; low-quality evidence) and pain frequency (SMD -1.28, 95% CI -1.84 to -0.72; Z = 4.48; P < 0.00001; 4 studies; 146 children; low-quality evidence). The only study of long-term effect reported continued benefit of hypnotherapy compared to usual care after five years, with 68% reporting treatment success compared to 20% of controls (P = 0.005).\nFor yoga therapy compared to control, we found no evidence of effectiveness on pain intensity reduction postintervention (SMD -0.31, 95% CI -0.67 to 0.05; Z = 1.69; P = 0.09; 3 studies; 122 children; low-quality evidence).\nThe single study of written self-disclosure therapy reported no benefit for pain.\nThere was no evidence of effect from the pooled analyses for any type of intervention on the secondary outcomes of school performance, social or psychological functioning, and quality of daily life.\nThere were no adverse effects for any of the interventions reported.\nAuthors' conclusions\nThe data from trials to date provide some evidence for beneficial effects of CBT and hypnotherapy in reducing pain in the short term in children and adolescents presenting with RAP. There was no evidence for the effectiveness of yoga therapy or written self-disclosure therapy. There were insufficient data to explore effects of treatment by RAP subtype.\nHigher-quality, longer-duration trials are needed to fully investigate the effectiveness of psychosocial interventions. Identifying the active components of the interventions and establishing whether benefits are sustained in the long term are areas of priority. Future research studies would benefit from employing active control groups to help minimise potential bias from wait-list control designs and to help account for therapist and intervention time.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do psychosocial therapies reduce pain in children and adolescents with recurrent abdominal pain?"
}
]
|
query-laysum | 4046 | [
{
"role": "user",
"content": "Abstract: Background\nThe projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether insulin secretagogues (sulphonylureas and meglitinide analogues) are able to prevent or delay T2DM and its associated complications in people at risk for the development of T2DM is unknown.\nObjectives\nTo assess the effects of insulin secretagogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was April 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of 12 weeks or more comparing insulin secretagogues with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with impaired fasting glucose, impaired glucose tolerance, moderately elevated HbA1c or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles/records, assessed quality and extracted outcome data independently. One review author extracted data which were checked by a second review author. We resolved discrepancies by consensus or the involvement of a third review author. For meta-analyses we used a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We carried out trial sequential analyses (TSAs) for all outcomes that could be meta-analysed. We assessed the overall quality of the evidence by using the GRADE instrument.\nMain results\nWe included six RCTs with 10,018 participants; 4791 participants with data on allocation to intervention groups were randomised to a second- or third-generation sulphonylurea or a meglitinide analogue as monotherapy and 29 participants were randomised to a second-generation sulphonylurea plus metformin. Three trials investigated a second-generation sulphonylurea, two trials investigated a third-generation sulphonylurea and one trial a meglitinide analogue. A total of 4873 participants with data on allocation to control groups were randomised to a comparator group; 4820 participants were randomised to placebo, 23 to diet and exercise, and 30 participants to metformin monotherapy. One RCT of nateglinide contributed 95% of all participants. The duration of the intervention varied from six months to five years. We judged none of the included trials as at low risk of bias for all 'Risk of bias' domains.\nAll-cause and cardiovascular mortality following sulphonylurea (glimepiride) treatment were rarely observed (very low-quality evidence). The RR for incidence of T2DM comparing glimepiride monotherapy with placebo was 0.75; 95% CI 0.54 to 1.04; P = 0.08; 2 trials; 307 participants; very low-quality evidence. One of the trials reporting on the incidence of T2DM did not define the diagnostic criteria used. The other trial diagnosed T2DM as two consecutive fasting blood glucose values ≥ 6.1 mmol/L. TSA showed that only 4.5% of the diversity-adjusted required information size was accrued so far. No trial reported data on serious adverse events, non-fatal myocardial infarction (MI), non-fatal stroke, congestive heart failure (HF), health-related quality of life or socioeconomic effects.\nOne trial with a follow-up of five years compared a meglitinide analogue (nateglinide) with placebo. A total of 310/4645 (6.7%) participants allocated to nateglinide died compared with 312/4661 (6.7%) participants allocated to placebo (hazard ratio (HR) 1.00; 95% CI 0.85 to 1.17; P = 0.98; moderate-quality evidence). The two main criteria for diagnosing T2DM were a fasting plasma glucose level ≥ 7.0 mmol/L or a 2-hour post challenge glucose ≥ 11.1 mmol/L. T2DM developed in 1674/4645 (36.0%) participants in the nateglinide group and in 1580/4661 (33.9%) in the placebo group (HR 1.07; 95% CI 1.00 to 1.15; P = 0.05; moderate-quality evidence). One or more serious adverse event was reported in 2066/4602 (44.9%) participants allocated to nateglinide compared with 2089/4599 (45.6%) participants allocated to placebo. A total of 126/4645 (2.7%) participants allocated to nateglinide died because of cardiovascular disease compared with 118/4661 (2.5%) participants allocated to placebo (HR 1.07; 95% CI 0.83 to 1.38; P = 0.60; moderate-quality evidence). Comparing participants receiving nateglinide with those receiving placebo for the outcomes MI, non-fatal stroke and HF gave the following event rates: MI 116/4645 (2.5%) versus 122/4661 (2.6%), stroke 100/4645 (2.2%) versus 110/4661 (2.4%) and numbers hospitalised for HF 85/4645 (1.8%) versus 100/4661 (2.1%) - (HR 0.85; 95% CI 0.64 to 1.14; P = 0.27). The quality of the evidence was moderate for all these outcomes. Health-related quality of life or socioeconomic effects were not reported.\nAuthors' conclusions\nThere is insufficient evidence to demonstrate whether insulin secretagogues compared mainly with placebo reduce the risk of developing T2DM and its associated complications in people at increased risk for the development of T2DM. Most trials did not investigate patient-important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Can the group of glucose-lowering drugs called insulin secretagogues prevent or delay the development of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus?"
}
]
|
query-laysum | 4047 | [
{
"role": "user",
"content": "Abstract: Background\nWork-related musculoskeletal disorders are a group of musculoskeletal disorders that comprise one of the most common disorders related to occupational sick leave worldwide. Musculoskeletal disorders accounted for 21% to 28% of work absenteeism days in 2017/2018 in the Netherlands, Germany and the UK. There are several interventions that may be effective in tackling the high prevalence of work-related musculoskeletal disorders among workers, such as physical, cognitive and organisational interventions. In this review, we will focus on work breaks as a measure of primary prevention, which are a type of organisational intervention.\nObjectives\nTo compare the effectiveness of different work-break schedules for preventing work-related musculoskeletal symptoms and disorders in healthy workers, when compared to conventional or alternate work-break schedules.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, PsycINFO, SCOPUS, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform, to April/May 2019. In addition, we searched references of the included studies and of relevant literature reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) of work-break interventions for preventing work-related musculoskeletal symptoms and disorders among workers. The studies were eligible for inclusion when intervening on work-break frequency, duration and/or type, compared to conventional or an alternate work-break intervention. We included only those studies in which the investigated population included healthy, adult workers, who were free of musculoskeletal complaints during study enrolment, without restrictions to sex or occupation. The primary outcomes were newly diagnosed musculoskeletal disorders, self-reported musculoskeletal pain, discomfort or fatigue, and productivity or work performance. We considered workload changes as secondary outcomes.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full texts for study eligibility, extracted data and assessed risk of bias. We contacted authors for additional study data where required. We performed meta-analyses, where possible, and we assessed the overall quality of the evidence for each outcome of each comparison using the five GRADE considerations.\nMain results\nWe included six studies (373 workers), four parallel RCTs, one cross-over RCT, and one combined parallel plus cross-over RCT. At least 295 of the employees were female and at least 39 male; for the remaining 39 employees, the sex was not specified in the study trial. The studies investigated different work-break frequencies (five studies) and different work-break types (two studies). None of the studies investigated different work-break durations. We judged all studies to have a high risk of bias. The quality of the evidence for the primary outcomes of self-reported musculoskeletal pain, discomfort and fatigue was low; the quality of the evidence for the primary outcomes of productivity and work performance was very low. The studies were executed in Europe or Northern America, with none from low- to middle-income countries. One study could not be included in the data analyses, because no detailed results have been reported.\nChanges in the frequency of work breaks\nThere is low-quality evidence that additional work breaks may not have a considerable effect on musculoskeletal pain, discomfort or fatigue, when compared with no additional work breaks (standardised mean difference (SMD) -0.08; 95% CI -0.35 to 0.18; three studies; 225 participants). Additional breaks may not have a positive effect on productivity or work performance, when compared with no additional work breaks (SMD -0.07; 95% CI -0.33 to 0.19; three studies; 225 participants; very low-quality evidence).\nWe found low-quality evidence that additional work breaks may not have a considerable effect on participant-reported musculoskeletal pain, discomfort or fatigue (MD 1.80 on a 100-mm VAS scale; 95% CI -41.07 to 64.37; one study; 15 participants), when compared to work breaks as needed (i.e. microbreaks taken at own discretion). There is very low-quality evidence that additional work breaks may have a positive effect on productivity or work performance, when compared to work breaks as needed (MD 542.5 number of words typed per 3-hour recording session; 95% CI 177.22 to 907.78; one study; 15 participants).\nAdditional higher frequency work breaks may not have a considerable effect on participant-reported musculoskeletal pain, discomfort or fatigue (MD 11.65 on a 100-mm VAS scale; 95% CI -41.07 to 64.37; one study; 10 participants; low-quality evidence), when compared to additional lower frequency work breaks. We found very low-quality evidence that additional higher frequency work breaks may not have a considerable effect on productivity or work performance (MD -83.00 number of words typed per 3-hour recording session; 95% CI -305.27 to 139.27; one study; 10 participants), when compared to additional lower frequency work breaks.\nChanges in the duration of work breaks\nNo trials were identified that assessed the effect of different durations of work breaks.\nChanges in the type of work break\nWe found low-quality evidence that active breaks may not have a considerable positive effect on participant-reported musculoskeletal pain, discomfort and fatigue (MD -0.17 on a 1-7 NRS scale; 95% CI -0.71 to 0.37; one study; 153 participants), when compared to passive work breaks.\nRelaxation work breaks may not have a considerable effect on participant-reported musculoskeletal pain, discomfort or fatigue, when compared to physical work breaks (MD 0.20 on a 1-7 NRS scale; 95% CI -0.43 to 0.82; one study; 97 participants; low-quality evidence).\nAuthors' conclusions\nWe found low-quality evidence that different work-break frequencies may have no effect on participant-reported musculoskeletal pain, discomfort and fatigue. For productivity and work performance, evidence was of very low-quality that different work-break frequencies may have a positive effect. For different types of break, there may be no effect on participant-reported musculoskeletal pain, discomfort and fatigue according to low-quality evidence. Further high-quality studies are needed to determine the effectiveness of frequency, duration and type of work-break interventions among workers, if possible, with much higher sample sizes than the studies included in the current review. Furthermore, work-break interventions should be reconsidered, taking into account worker populations other than office workers, and taking into account the possibility of combining work-break intervention with other interventions such as ergonomic training or counselling, which may may possibly have an effect on musculoskeletal outcomes and work performance.\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": "Effect of different work-break frequencies\nFive of the six studies evaluated different work-break frequencies. The implementation of additional work breaks (three studies) may not have an effect on musculoskeletal pain, discomfort or fatigue when compared to no additional work breaks or work breaks taken as needed. Additional work breaks (three studies) may have a positive effect on productivity and work performance when compared to a conventional work-break schedule. Additional higher frequency work breaks have been compared with additional lower frequency work breaks in one study, which resulted in no differences in participant-reported musculoskeletal pain, discomfort and fatigue, nor in productivity and work performance.\nEffect of different work-break durations\nNone of the studies evaluated the effect of duration of work breaks.\nEffect of different work-break types\nTwo of the six studies evaluated different work-break types. Active work breaks (one study) may not reduce nor increase the incidence of participant-reported musculoskeletal pain, discomfort and fatigue, or productivity and work performance. Similarly, different active work breaks have been compared with one another (one study), i.e. relaxation and physical active work breaks, which revealed no differences in participant-reported musculoskeletal pain, discomfort and fatigue, nor in productivity and work performance."
}
]
|
query-laysum | 4048 | [
{
"role": "user",
"content": "Abstract: Background\nRehabilitation based upon research evidence gives stroke survivors the best chance of recovery. There is substantial research to guide practice in stroke rehabilitation, yet uptake of evidence by healthcare professionals is typically slow and patients often do not receive evidence-based care. Implementation interventions are an important means to translate knowledge from research to practice and thus optimise the care and outcomes for stroke survivors. A synthesis of research evidence is required to guide the selection and use of implementation interventions in stroke rehabilitation.\nObjectives\nTo assess the effects of implementation interventions to promote the uptake of evidence-based practices (including clinical assessments and treatments recommended in evidence-based guidelines) in stroke rehabilitation and to assess the effects of implementation interventions tailored to address identified barriers to change compared to non-tailored interventions in stroke rehabilitation.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and eight other databases to 17 October 2019. We searched OpenGrey, performed citation tracking and reference checking for included studies and contacted authors of included studies to obtain further information and identify potentially relevant studies.\nSelection criteria\nWe included individual and cluster randomised trials, non-randomised trials, interrupted time series studies and controlled before-after studies comparing an implementation intervention to no intervention or to another implementation approach in stroke rehabilitation. Participants were qualified healthcare professionals working in stroke rehabilitation and the patients they cared for. Studies were considered for inclusion regardless of date, language or publication status. Main outcomes were healthcare professional adherence to recommended treatment, patient adherence to recommended treatment, patient health status and well-being, healthcare professional intention and satisfaction, resource use outcomes and adverse effects.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and certainty of evidence using GRADE. The primary comparison was any implementation intervention compared to no intervention.\nMain results\nNine cluster randomised trials (12,428 patient participants) and three ongoing trials met our selection criteria. Five trials (8865 participants) compared an implementation intervention to no intervention, three trials (3150 participants) compared one implementation intervention to another implementation intervention, and one three-arm trial (413 participants) compared two different implementation interventions to no intervention. Eight trials investigated multifaceted interventions; educational meetings and educational materials were the most common components. Six trials described tailoring the intervention content to identified barriers to change. Two trials focused on evidence-based stroke rehabilitation in the acute setting, four focused on the subacute inpatient setting and three trials focused on stroke rehabilitation in the community setting.\nWe are uncertain if implementation interventions improve healthcare professional adherence to evidence-based practice in stroke rehabilitation compared with no intervention as the certainty of the evidence was very low (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.53 to 2.64; 2 trials, 39 clusters, 1455 patient participants; I2 = 0%). Low-certainty evidence indicates implementation interventions in stroke rehabilitation may lead to little or no difference in patient adherence to recommended treatment (number of recommended performed outdoor journeys adjusted mean difference (MD) 0.5, 95% CI –1.8 to 2.8; 1 trial, 21 clusters, 100 participants) and patient psychological well-being (standardised mean difference (SMD) –0.02, 95% CI –0.54 to 0.50; 2 trials, 65 clusters, 1273 participants; I2 = 0%) compared with no intervention. Moderate-certainty evidence indicates implementation interventions in stroke rehabilitation probably lead to little or no difference in patient health-related quality of life (MD 0.01, 95% CI –0.02 to 0.05; 2 trials, 65 clusters, 1242 participants; I2 = 0%) and activities of daily living (MD 0.29, 95% CI –0.16 to 0.73; 2 trials, 65 clusters, 1272 participants; I2 = 0%) compared with no intervention.\nNo studies reported the effects of implementation interventions in stroke rehabilitation on healthcare professional intention to change behaviour or satisfaction.\nFive studies reported economic outcomes, with one study reporting cost-effectiveness of the implementation intervention. However, this was assessed at high risk of bias. The other four studies did not demonstrate the cost-effectiveness of interventions.\nTailoring interventions to identified barriers did not alter results.\nWe are uncertain of the effect of one implementation intervention versus another given the limited very low-certainty evidence.\nAuthors' conclusions\nWe are uncertain if implementation interventions improve healthcare professional adherence to evidence-based practice in stroke rehabilitation compared with no intervention as the certainty of the evidence is very low.\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": "Patients who have a stroke and participate in rehabilitation do not always receive treatments based on evidence. Considerable research has been conducted in stroke rehabilitation but this information does not easily translate to clinical practice or it takes a long time to be used by healthcare professionals. Strategies are needed to help healthcare professionals use best evidence when working with stroke survivors.\nWe included studies that compared a group of healthcare professionals receiving support to use evidence in stroke rehabilitation with another group who did not. We were interested to see whether healthcare professionals used more evidence in practice, whether patients adhered to evidence-based recommendations from healthcare professionals, and whether patient health and well-being improved."
}
]
|
query-laysum | 4049 | [
{
"role": "user",
"content": "Abstract: Background\nSystematic reviews showed that systemic postnatal corticosteroids reduce the risk of bronchopulmonary dysplasia (BPD) in preterm infants. However, corticosteroids have also been associated with an increased risk of neurodevelopmental impairment. It is unknown whether these beneficial and adverse effects are modulated by differences in corticosteroid treatment regimens related to type of steroid, timing of treatment initiation, duration, pulse versus continuous delivery, and cumulative dose.\nObjectives\nTo assess the effects of different corticosteroid treatment regimens on mortality, pulmonary morbidity, and neurodevelopmental outcome in very low birth weight infants.\nSearch methods\nWe conducted searches in September 2022 of MEDLINE, the Cochrane Library, Embase, and two trial registries, without date, language or publication- type limits. Other search methods included checking the reference lists of included studies for randomized controlled trials (RCTs) and quasi-randomized trials.\nSelection criteria\nWe included RCTs comparing two or more different treatment regimens of systemic postnatal corticosteroids in preterm infants at risk for BPD, as defined by the original trialists. The following comparisons of intervention were eligible: alternative corticosteroid (e.g. hydrocortisone) versus another corticosteroid (e.g. dexamethasone); lower (experimental arm) versus higher dosage (control arm); later (experimental arm) versus earlier (control arm) initiation of therapy; a pulse-dosage (experimental arm) versus continuous-dosage regimen (control arm); and individually-tailored regimens (experimental arm) based on the pulmonary response versus a standardized (predetermined administered to every infant) regimen (control arm). We excluded placebo-controlled and inhalation corticosteroid studies.\nData collection and analysis\nTwo authors independently assessed eligibility and risk of bias of trials, and extracted data on study design, participant characteristics and the relevant outcomes. We asked the original investigators to verify if data extraction was correct and, if possible, to provide any missing data. We assessed the following primary outcome: the composite outcome mortality or BPD at 36 weeks' postmenstrual age (PMA). Secondary outcomes were: the components of the composite outcome; in-hospital morbidities and pulmonary outcomes, and long-term neurodevelopmental sequelae. We analyzed data using Review Manager 5 and used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 16 studies in this review; of these, 15 were included in the quantitative synthesis. Two trials investigated multiple regimens, and were therefore included in more than one comparison. Only RCTs investigating dexamethasone were identified.\nEight studies enrolling a total of 306 participants investigated the cumulative dosage administered; these trials were categorized according to the cumulative dosage investigated, 'low' being < 2 mg/kg, 'moderate' being between 2 and 4 mg/kg, and 'high' > 4 mg/kg; three studies contrasted a high versus a moderate cumulative dose, and five studies a moderate versus a low cumulative dexamethasone dose. We graded the certainty of the evidence low to very low because of the small number of events, and the risk of selection, attrition and reporting bias. Overall analysis of the studies investigating a higher dose versus a lower dosage regimen showed no differences in the outcomes BPD, the composite outcome death or BPD at 36 weeks' PMA, or abnormal neurodevelopmental outcome in survivors assessed. Although there was no evidence of a subgroup difference for the higher versus lower dosage regimens comparisons (Chi2 = 2.91, df = 1 (P = 0.09), I2 = 65.7%), a larger effect was seen in the subgroup analysis of moderate-dosage regimens versus high-dosage regimens for the outcome cerebral palsy in survivors. In this subgroup analysis, there was an increased risk of cerebral palsy (RR 6.85, 95% CI 1.29 to 36.36; RD 0.23, 95% CI 0.08 to 0.37; P = 0.02; I² = 0%; NNTH 5, 95% CI 2.6 to 12.7; 2 studies, 74 infants). There was evidence of subgroup differences for higher versus lower dosage regimens comparisons for the combined outcomes death or cerebral palsy, and death and abnormal neurodevelopmental outcomes (Chi2 = 4.25, df = 1 (P = 0.04), I2 = 76.5%; and Chi2 = 7.11, df = 1 (P = 0.008), I2 = 85.9%, respectively). In the subgroup analysis comparing a high dosage regimen of dexamethasone versus a moderate cumulative-dosage regimen, there was an increased risk of death or cerebral palsy (RR 3.20, 95% CI 1.35 to 7.58; RD 0.25, 95% CI 0.09 to 0.41; P = 0.002; I² = 0%; NNTH 5, 95% CI 2.4 to 13.6; 2 studies, 84 infants; moderate-certainty evidence), and death or abnormal neurodevelopmental outcome (RR 3.41, 95% CI 1.44 to 8.07; RD 0.28, 95% CI 0.11 to 0.44; P = 0.0009; I² = 0%; NNTH 4, 95% CI 2.2 to 10.4; 2 studies, 84 infants; moderate-certainty evidence). There were no differences in outcomes between a moderate- and a low-dosage regimen.\nFive studies enrolling 797 infants investigated early initiation of dexamethasone therapy versus a moderately early or delayed initiation, and showed no significant differences in the overall analyses for the primary outcomes. The two RCTs investigating a continuous versus a pulse dexamethasone regimen showed an increased risk of the combined outcome death or BPD when using the pulse therapy. Finally, three trials investigating a standard regimen versus a participant-individualized course of dexamethasone showed no difference in the primary outcome and long-term neurodevelopmental outcomes.\nWe assessed the GRADE certainty of evidence for all comparisons discussed above as moderate to very low, because the validity of all comparisons is hampered by unclear or high risk of bias, small samples of randomized infants, heterogeneity in study population and design, non-protocolized use of ‘rescue’ corticosteroids and lack of long-term neurodevelopmental data in most studies.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of different corticosteroid regimens on the outcomes mortality, pulmonary morbidity, and long term neurodevelopmental impairment. Despite the fact that the studies investigating higher versus lower dosage regimens showed that higher-dosage regimens may reduce the incidence of death or neurodevelopmental impairment, we cannot conclude what the optimal type, dosage, or timing of initiation is for the prevention of BPD in preterm infants, based on current level of evidence. Further high quality trials would be needed to establish the optimal systemic postnatal corticosteroid dosage regimen.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What timing and dosage of corticosteroids (a class of drugs that suppress inflammation) are best for preventing lung injury in babies born very early."
}
]
|
query-laysum | 4050 | [
{
"role": "user",
"content": "Abstract: Background\nComplex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is an identifiable nerve lesion. Guidelines recommend the inclusion of a variety of physiotherapy interventions as part of the multimodal treatment of people with CRPS. This is the first update of the review originally published in Issue 2, 2016.\nObjectives\nTo determine the effectiveness of physiotherapy interventions for treating pain and disability associated with CRPS types I and II in adults.\nSearch methods\nFor this update we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDro, Web of Science, DARE and Health Technology Assessments from February 2015 to July 2021 without language restrictions, we searched the reference lists of included studies and we contacted an expert in the field. We also searched additional online sources for unpublished trials and trials in progress.\nSelection criteria\nWe included randomised controlled trials (RCTs) of physiotherapy interventions compared with placebo, no treatment, another intervention or usual care, or other physiotherapy interventions in adults with CRPS I and II. Primary outcomes were pain intensity and disability. Secondary outcomes were composite scores for CRPS symptoms, health-related quality of life (HRQoL), patient global impression of change (PGIC) scales and adverse effects.\nData collection and analysis\nTwo review authors independently screened database searches for eligibility, extracted data, evaluated risk of bias and assessed the certainty of evidence using the GRADE system.\nMain results\nWe included 16 new trials (600 participants) along with the 18 trials from the original review totalling 34 RCTs (1339 participants). Thirty-three trials included participants with CRPS I and one trial included participants with CRPS II. Included trials compared a diverse range of interventions including physical rehabilitation, electrotherapy modalities, cortically directed rehabilitation, electroacupuncture and exposure-based approaches. Most interventions were tested in small, single trials. Most were at high risk of bias overall (27 trials) and the remainder were at 'unclear' risk of bias (seven trials). For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as very low, downgraded due to serious study limitations, imprecision and inconsistency. Included trials rarely reported adverse effects.\nPhysiotherapy compared with minimal care for adults with CRPS I\nOne trial (135 participants) of multimodal physiotherapy, for which pain data were unavailable, found no between-group differences in pain intensity at 12-month follow-up. Multimodal physiotherapy demonstrated a small between-group improvement in disability at 12 months follow-up compared to an attention control (Impairment Level Sum score, 5 to 50 scale; mean difference (MD) -3.7, 95% confidence interval (CI) -7.13 to -0.27) (very low-certainty evidence). Equivalent data for pain were not available. Details regarding adverse events were not reported.\nPhysiotherapy compared with minimal care for adults with CRPS II\nWe did not find any trials of physiotherapy compared with minimal care for adults with CRPS II.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of physiotherapy interventions on pain and disability in CRPS. This conclusion is similar to our 2016 review. Large-scale, high-quality RCTs with longer-term follow-up are required to test the effectiveness of physiotherapy-based interventions for treating pain and disability in adults with CRPS I and II.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for clinical trials that involved adults with CRPS, which compared physiotherapy treatments to placebo treatments or routine care or which compared different physiotherapy treatments to each other.\nWe compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as trial methods, size and length of follow-up."
}
]
|
query-laysum | 4051 | [
{
"role": "user",
"content": "Abstract: Background\nCerebral palsy is the most common physical disability in childhood. Mechanically assisted walking training can be provided with or without body weight support to enable children with cerebral palsy to perform repetitive practice of complex gait cycles. It is important to examine the effects of mechanically assisted walking training to identify evidence-based treatments to improve walking performance.\nObjectives\nTo assess the effects of mechanically assisted walking training compared to control for walking, participation, and quality of life in children with cerebral palsy 3 to 18 years of age.\nSearch methods\nIn January 2020, we searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers. We handsearched conference abstracts and checked reference lists of included studies.\nSelection criteria\nRandomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, comparing any type of mechanically assisted walking training (with or without body weight support) with no walking training or the same dose of overground walking training in children with cerebral palsy (classified as Gross Motor Function Classification System [GMFCS] Levels I to IV) 3 to 18 years of age.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review includes 17 studies with 451 participants (GMFCS Levels I to IV; mean age range 4 to 14 years) from outpatient settings. The duration of the intervention period (4 to 12 weeks) ranged widely, as did intensity of training in terms of both length (15 minutes to 40 minutes) and frequency (two to five times a week) of sessions. Six studies were funded by grants, three had no funding support, and eight did not report information on funding. Due to the nature of the intervention, all studies were at high risk of performance bias.\nMechanically assisted walking training without body weight support versus no walking training\nFour studies (100 participants) assessed this comparison. Compared to no walking, mechanically assisted walking training without body weight support increased walking speed (mean difference [MD] 0.05 meter per second [m/s] [change scores], 95% confidence interval [CI] 0.03 to 0.07; 1 study, 10 participants; moderate-quality evidence) as measured by the Biodex Gait Trainer 2™ (Biodex, Shirley, NY, USA) and improved gross motor function (standardized MD [SMD] 1.30 [postintervention scores], 95% CI 0.49 to 2.11; 2 studies, 60 participants; low-quality evidence) postintervention. One study (30 participants) reported no adverse events (low-quality evidence). No study measured participation or quality of life.\nMechanically assisted walking training without body weight support versus the same dose of overground walking training\nTwo studies (55 participants) assessed this comparison. Compared to the same dose of overground walking, mechanically assisted walking training without body weight support increased walking speed (MD 0.25 m/s [change or postintervention scores], 95% CI 0.13 to 0.37; 2 studies, 55 participants; moderate-quality evidence) as assessed by the 6-minute walk test or Vicon gait analysis. It also improved gross motor function (MD 11.90% [change scores], 95% CI 2.98 to 20.82; 1 study, 35 participants; moderate-quality evidence) as assessed by the Gross Motor Function Measure (GMFM) and participation (MD 8.20 [change scores], 95% CI 5.69 to 10.71; 1 study, 35 participants; moderate-quality evidence) as assessed by the Pediatric Evaluation of Disability Inventory (scored from 0 to 59), compared to the same dose of overground walking training. No study measured adverse events or quality of life.\nMechanically assisted walking training with body weight support versus no walking training\nEight studies (210 participants) assessed this comparison. Compared to no walking training, mechanically assisted walking training with body weight support increased walking speed (MD 0.07 m/s [change and postintervention scores], 95% CI 0.06 to 0.08; 7 studies, 161 participants; moderate-quality evidence) as assessed by the 10-meter or 8-meter walk test. There were no differences between groups in gross motor function (MD 1.09% [change and postintervention scores], 95% CI -0.57 to 2.75; 3 studies, 58 participants; low-quality evidence) as assessed by the GMFM; participation (SMD 0.33 [change scores], 95% CI -0.27 to 0.93; 2 studies, 44 participants; low-quality evidence); and quality of life (MD 9.50% [change scores], 95% CI -4.03 to 23.03; 1 study, 26 participants; low-quality evidence) as assessed by the Pediatric Quality of Life Cerebral Palsy Module (scored 0 [bad] to 100 [good]). Three studies (56 participants) reported no adverse events (low-quality evidence).\nMechanically assisted walking training with body weight support versus the same dose of overground walking training\nThree studies (86 participants) assessed this comparison. There were no differences between groups in walking speed (MD -0.02 m/s [change and postintervention scores], 95% CI -0.08 to 0.04; 3 studies, 78 participants; low-quality evidence) as assessed by the 10-meter or 5-minute walk test; gross motor function (MD -0.73% [postintervention scores], 95% CI -14.38 to 12.92; 2 studies, 52 participants; low-quality evidence) as assessed by the GMFM; and participation (MD -4.74 [change scores], 95% CI -11.89 to 2.41; 1 study, 26 participants; moderate-quality evidence) as assessed by the School Function Assessment (scored from 19 to 76). No study measured adverse events or quality of life.\nAuthors' conclusions\nCompared with no walking, mechanically assisted walking training probably results in small increases in walking speed (with or without body weight support) and may improve gross motor function (with body weight support). Compared with the same dose of overground walking, mechanically assisted walking training with body weight support may result in little to no difference in walking speed and gross motor function, although two studies found that mechanically assisted walking training without body weight support is probably more effective than the same dose of overground walking training for walking speed and gross motor function. Not many studies reported adverse events, although those that did appeared to show no differences between groups. The results are largely not clinically significant, sample sizes are small, and risk of bias and intensity of intervention vary across studies, making it hard to draw robust conclusions. Mechanically assisted walking training is a means to undertake high-intensity, repetitive, task-specific training and may be useful for children with poor concentration.\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 includes 17 studies involving a total of 451 children with a mean age range between 4 and 14 years. All children had cerebral palsy. We found four studies comparing mechanically assisted walking without body weight support to no walking; two studies comparing mechanically assisted walking without body weight support to the same amount of overground walking; eight studies comparing mechanically assisted walking plus body weight support to no walking; and three studies comparing mechanically assisted walking with body weight support to the same amount of overground walking. Mechanically assisted training was provided for 15 to 40 minutes a session, two to five times a week, for 4 to 12 weeks. Five studies were funded by a grant, and one study was funded by two different grants. Eight studies did not report funding information, and three studies received no funding support.\nThe evidence is current to January 2020."
}
]
|
query-laysum | 4052 | [
{
"role": "user",
"content": "Abstract: Background\nMedications with anticholinergic properties are commonly prescribed to older adults. The cumulative anticholinergic effect of all the medications a person takes is referred to as the 'anticholinergic burden' because of its potential to cause adverse effects. It is possible that high anticholinergic burden may be a risk factor for development of cognitive decline or dementia. There are various scales available to measure anticholinergic burden but agreement between them is often poor.\nObjectives\nTo assess whether anticholinergic burden, as defined at the level of each individual scale, is a prognostic factor for future cognitive decline or dementia in cognitively unimpaired older adults.\nSearch methods\nWe searched the following databases from inception to 24 March 2021: MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), and ISI Web of Science Core Collection (ISI Web of Science).\nSelection criteria\nWe included prospective and retrospective longitudinal cohort and case-control observational studies with a minimum of one year' follow-up that examined the association between an anticholinergic burden measurement scale and future cognitive decline or dementia in cognitively unimpaired older adults.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, and undertook data extraction, assessment of risk of bias, and GRADE assessment. We extracted odds ratios (OR) and hazard ratios, with 95% confidence intervals (CI), and linear data on the association between anticholinergic burden and cognitive decline or dementia. We intended to pool each metric separately; however, only OR-based data were suitable for pooling via a random-effects meta-analysis. We initially established adjusted and unadjusted pooled rates for each available anticholinergic scale; then, as an exploratory analysis, established pooled rates on the prespecified association across scales. We examined variability based on severity of anticholinergic burden.\nMain results\nWe identified 25 studies that met our inclusion criteria (968,428 older adults). Twenty studies were conducted in the community care setting, two in primary care clinics, and three in secondary care settings. Eight studies (320,906 participants) provided suitable data for meta-analysis. The Anticholinergic Cognitive Burden scale (ACB scale) was the only scale with sufficient data for 'scale-based' meta-analysis. Unadjusted ORs suggested an increased risk for cognitive decline or dementia in older adults with an anticholinergic burden (OR 1.47, 95% CI 1.09 to 1.96) and adjusted ORs similarly suggested an increased risk for anticholinergic burden, defined according to the ACB scale (OR 2.63, 95% CI 1.09 to 6.29). Exploratory analysis combining adjusted ORs across available scales supported these results (OR 2.16, 95% CI 1.38 to 3.38), and there was evidence of variability in risk based on severity of anticholinergic burden (ACB scale 1: OR 2.18, 95% CI 1.11 to 4.29; ACB scale 2: OR 2.71, 95% CI 2.01 to 3.56; ACB scale 3: OR 3.27, 95% CI 1.41 to 7.61); however, overall GRADE evaluation of certainty of the evidence was low.\nAuthors' conclusions\nThere is low-certainty evidence that older adults without cognitive impairment who take medications with anticholinergic effects may be at increased risk of cognitive decline or dementia.\n\nGiven the provided abstract, please respond to the following query: \"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 published up to 24 March 2021."
}
]
|
query-laysum | 4053 | [
{
"role": "user",
"content": "Abstract: Background\nThe optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited.\nObjectives\nTo determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions.\nSelection criteria\nWe included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up.\nData collection and analysis\nTwo review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² <= 40%) and a random-effects model when heterogeneity was moderate or substantial (I² > 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables.\nMain results\nWe included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non-paroxysmal atrial fibrillation. We generally assessed the included studies as having low or unclear risk of bias across multiple domains, with reported outcomes generally lacking precision due to low event rates. Evidence showed that RFCA was superior to antiarrhythmic drugs in achieving freedom from atrial arrhythmias (RR 1.84, 95% CI 1.17 to 2.88; 3 studies, 261 participants; low-quality evidence), reducing the need for cardioversion (RR 0.62, 95% CI 0.47 to 0.82; 3 studies, 261 participants; moderate-quality evidence), and reducing cardiac-related hospitalisation (RR 0.27, 95% CI 0.10 to 0.72; 2 studies, 216 participants; low-quality evidence) at 12 months follow-up. There was substantial uncertainty surrounding the effect of RFCA regarding significant bradycardia (or need for a pacemaker) (RR 0.20, 95% CI 0.02 to 1.63; 3 studies, 261 participants; low-quality evidence), periprocedural complications, and other safety outcomes (RR 0.94, 95% CI 0.16 to 5.68; 3 studies, 261 participants; very low-quality evidence).\nAuthors' conclusions\nIn people with non-paroxysmal atrial fibrillation, evidence suggests a superiority of RFCA to antiarrhythmic drugs in achieving freedom from atrial arrhythmias, reducing the need for cardioversion, and reducing cardiac-related hospitalisations. There was uncertainty surrounding the effect of RFCA with significant bradycardia (or need for a pacemaker), periprocedural complications, and other safety outcomes. Evidence should be interpreted with caution, as event rates were low and quality of evidence ranged from moderate to very low.\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 from their inception to 1 April 2016 and found three studies where people are randomly allocated into one of two or more treatment groups (known as randomised trials). The three trials included 261 adults (mean age: 60 years) comparing catheter ablation (159 participants) to heart rhythm drugs (102) for non-paroxysmal atrial fibrillation at 12 months follow-up."
}
]
|
query-laysum | 4054 | [
{
"role": "user",
"content": "Abstract: Background\nConventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.\nObjectives\nTo assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.\nSearch methods\nWe searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.\nSelection criteria\nWe considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.\nData collection and analysis\nWe analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.\nMain results\nWe included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment.\nAdalimumab versus placebo\nFifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain.\nAdalimumab versus active comparators\nNo studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).\nAuthors' conclusions\nAdalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.\n\nGiven the provided abstract, please respond to the following query: \"What is the purpose of this study?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The purpose of this study was to determine whether adalimumab is an effective medication for maintenance of remission in people with inactive CD, and whether it is associated with any harms or side effects."
}
]
|
query-laysum | 4055 | [
{
"role": "user",
"content": "Abstract: Background\nLower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) represent one of the most common clinical complaints in men. Alpha-blockers are widely used as first-line therapy for men with LUTS secondary to BPO, but up to one third of men report no improvement in their LUTS after taking alpha-blockers. Anticholinergics used in addition to alpha-blockers may help improve symptoms but it is uncertain how effective they are.\nObjectives\nTo assess the effects of combination therapy with anticholinergics and alpha-blockers in men with LUTS related to BPO.\nSearch methods\nWe performed a comprehensive search of medical literature, including the Cochrane Library, MEDLINE, Embase, and trials registries, with no restrictions on the language of publication or publication status. The date of the latest search was 7 August 2020.\nSelection criteria\nWe included randomized controlled trials. Inclusion criteria were men with LUTS secondary to BPO, ages 40 years or older, and a total International Prostate Symptom Score of 8 or greater. We excluded trials of men with a known neurogenic bladder due to spinal cord injury, multiple sclerosis, or central nervous system disease, and those examining medical therapy for men who were treated with surgery for BPO. We performed three comparisons: combination therapy versus placebo, combination therapy versus alpha-blockers monotherapy, and combination therapy versus anticholinergics monotherapy.\nData collection and analysis\nTwo review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and interpreted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We used the GRADE approach to rate the certainty of evidence.\nMain results\nWe included 23 studies with 6285 randomized men across three comparisons. The mean age of participants ranged from 54.4 years to 73.9 years (overall mean age 65.7 years). Of the included studies, 12 were conducted with a single-center setting, while 11 used a multi-center setting. We only found short-term effect (12 weeks to 12 months) of combination therapy based on available evidence.\nCombination therapy versus placebo: based on five studies with 2369 randomized participants, combination therapy may result in little or no difference in urologic symptom scores (mean difference (MD) –2.73, 95% confidence interval (CI) –5.55 to 0.08; low-certainty evidence). We are very uncertain about the effect of combination therapy on quality of life (QoL) (MD –0.97, 95% CI –2.11 to 0.16; very low-certainty evidence). Combination therapy likely increases adverse events (risk ratio (RR) 1.24, 95% CI 1.04 to 1.47; moderate-certainty evidence); based on 252 adverse events per 1000 participants in the placebo group, this corresponds to 61 more adverse events (95% CI 10 more to 119 more) per 1000 participants treated with combination therapy.\nCombination therapy versus alpha-blockers alone: based on 22 studies with 4904 randomized participants, we are very uncertain about the effect of combination therapy on urologic symptom scores (MD –2.04, 95% CI –3.56 to –0.52; very low-certainty evidence) and QoL (MD –0.71, 95% CI –1.03 to –0.38; very low-certainty evidence). Combination therapy may result in little or no difference in adverse events rate (RR 1.10, 95% CI 0.90 to 1.34; low-certainty evidence); based on 228 adverse events per 1000 participants in the alpha-blocker group, this corresponds to 23 more adverse events (95% CI 23 fewer to 78 more) per 1000 participants treated with combination therapy.\nCombination therapy compared to anticholinergics alone: based on three studies with 1218 randomized participants, we are very uncertain about the effect of combination therapy on urologic symptom scores (MD –3.71, 95% CI –9.41 to 1.98; very low-certainty evidence). Combination therapy may result in an improvement in QoL (MD –1.49, 95% CI –1.88 to –1.11; low-certainty evidence). Combination therapy likely results in little to no difference in adverse events (RR 1.26, 95% CI 0.81 to 1.95; moderate-certainty evidence); based on 115 adverse events per 1000 participants in the anticholinergic alone group, this corresponds to 4 fewer adverse events (95% CI 7 fewer to 13 more) per 1000 participants treated with combination therapy.\nAuthors' conclusions\nBased on the findings of the review, combination therapy with anticholinergics and alpha-blockers are associated with little or uncertain effects on urologic symptom scores compared to placebo, alpha-blockers, or anticholinergics monotherapy. However, combination therapy may result in an improvement in quality of life compared to anticholinergics monotherapy, but an uncertain effect compared to placebo, or alpha-blockers. Combination therapy likely increases adverse events compared to placebo, but not compared to alpha-blockers or anticholinergics monotherapy. The findings of this review were limited by study limitations, inconsistency, and imprecision. We were unable to conduct any of the predefined subgroup analyses.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is combination therapy with anticholinergics, a type of medicine that can relieve abnormal bladder contraction (where a man cannot control when he urinates), and alpha-blockers, a type of medicine that can relax the urethral muscle (the tube that carries urine from the bladder out through the penis during urination), effective and safe for managing urination difficulties and urgency related to enlarged prostate?"
}
]
|
query-laysum | 4056 | [
{
"role": "user",
"content": "Abstract: Background\nHepatitis C virus (HCV)-associated mixed cryoglobulinaemia is the manifestation of an inflammation of small and medium-sized vessels produced by a pathogenic IgM with rheumatoid factor activity generated by an expansion of B-cells. The immune complexes formed precipitate mainly in the skin, joints, kidneys or peripheral nerve fibres. Current therapeutic approaches are aimed at elimination of HCV infection, removal of cryoglobulins and also of the B-cell clonal expansions. The optimal treatment for it has not been established.\nObjectives\nThis review aims to look at the benefits and harms of the currently available treatment options to treat the HCV-associated mixed cryoglobulinaemia with active manifestations of vasculitis (cutaneous or glomerulonephritis).\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 30 November 2017 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs looking at interventions directed at treatment of HCV-associated cryoglobulinaemic vasculitis (immunosuppressive medications and plasma exchange therapy) have been included.\nData collection and analysis\nTwo authors independently assessed the retrieved titles and abstracts. Authors of included studies were contacted to obtain missing information. Statistical analyses were performed using random effects models and results expressed as risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI). The planned primary outcomes were kidney disease, skin vasculitis, musculoskeletal symptoms, peripheral joint arthralgia, peripheral neuropathies, liver involvement, interstitial lung involvement, widespread vasculitis and death. Other planned outcomes were: therapy duration, laboratory findings, adverse effects, antiviral therapy failure, B-cell lymphoma, endocrine disorders and costs of treatment.\nMain results\nTen studies were included in the review (394 participants). None of them evaluated direct-acting antivirals. Seven studies were single-centre studies and three were multicentre. The duration of the studies varied from six to 36 months. The risk of bias was generally unclear or low. Three different interventions were examined: use of rituximab (3 studies, 118 participants); interferon (IFN) (IFN compared to other strategies (5 studies, 223 participants); six IFN months versus one year (1 study, 36 participants), and immunoadsorption apheresis versus only immunosuppressive therapy (1 study, 17 participants).\nThe use of rituximab may slightly improve skin vasculitis (2 studies, 78 participants: RR 0.57, 95% CI 0.28 to 1.16; moderate certainty evidence) and made little of no difference to kidney disease (moderate certainty evidence). In terms of laboratory data, the effect of rituximab was uncertain for cryocrit (MD -2.01%, 95% CI -10.29% to 6.27%, low certainty evidence) and HCV replication. Rituximab may slightly increase infusion reactions compared to immunosuppressive medication (3 studies, 118 participants: RR 4.33, 95%CI 0.76 to 24.75, moderate certainty evidence) however discontinuations of the treatment due to adverse reactions were similar (3 studies, 118 participants: RR 0.97, 95% CI 0.22 to 4.36, moderate certainty evidence).\nEffects of lFN on clinical symptoms were evaluated only in narrative results. When laboratory parameters were assessed, IFN made little or no difference in levels of alanine transaminase (ALT) at six months (2 studies, 39 participants: MD -5.89 UI/L, 95%CI -55.77 to 43.99); rheumatoid factor activity at six months (1 study, 13 participants: MD 97.00 UI/mL, 95%CI -187.37 to 381.37), or C4 levels at 18 months (2 studies, 49 participants: MD -0.04 mg/dL, 95%CI -2.74 to 2.67). On the other hand, at 18 months IFN may probably decrease ALT (2 studies, 39 participants: MD -28.28 UI/L, 95%CI -48.03 to -8.54) and Ig M (-595.75 mg/dL, 95%CI -877.2 to -314.3), but all with low certainty evidence. One study reported infusion reactions may be higher in IFN group compared to immunosuppressive therapy (RR 27.82, 95%CI 1.72 to 449.18), and IFN may lead to higher discontinuations of the treatment due to adverse reactions (4 studies, 148 participants: RR 2.32, 95%CI 0.91 to 5.90) with low certainty evidence. Interferon therapy probably improved skin vasculitis (3 studies, 95 participants: RR 0.60, 95% CI 0.36 to 1.00) and proteinuria (2 studies, 49 participants: MD -1.98 g/24 h, 95% CI -2.89 to -1.07), without changing serum creatinine at 18 months (2 studies, 49 participants: MD -30.32 μmol/L, 95%CI -80.59 to 19.95).\nSix months versus one year treatment with IFN resulted in differences terms of the maintenance of the response, 89% of patients in the six months group presented a relapse and only 11% maintained a long-term response at one year, while in the one year group only 78% relapsed and long-term response was observed in 22%. The one-year therapy was linked to a higher number of side-effects (severe enough to cause the discontinuation of treatment in two cases) than the six-month schedule.\nOne study reported immunoadsorption apheresis had uncertain effects on skin vasculitis (RR 0.44, 95% CI 0.05 to 4.02), peripheral neuropathies (RR 2.70, 95%CI 0.13 to 58.24), and peripheral joint arthralgia (RR 2.70, 95%CI 0.13 to 58.24), cryocrit (MD 0.01%, 95%CI -1.86 to 1.88) at six months, and no infusion reactions were reported. However when clinical scores were evaluated, they reported changes were more favourable in immunoadsorption apheresis with higher remission of severe clinical complications (80% versus 33%, P = 0.05) compared to immunosuppressive treatment alone.\nIn terms of death, it was not possible to present a pooled intervention effect estimate because most of the studies reported no deaths, or did not report death as an outcome.\nAuthors' conclusions\nTo treat HCV-associated mixed cryoglobulinaemia, it may be beneficial to eliminate HCV infection by using antiviral treatment and to stop the immune response by using rituximab. For skin vasculitis and for some laboratory findings, it may be appropriate to combine antiviral treatment with deletion of B-cell clonal expansions by using of rituximab. The applicability of evidence reviewed here is limited by the absence of any studies with direct-acting antivirals, which are urgently needed to guide therapy.\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": "Considering the limitation of the lack of studies with new direct-acting antiviral agents, some benefits in terms of skin, nerve or kidney illness where found when rituximab, antiviral treatment with IFN or immunoadsorption apheresis were used compared to using other immunosuppressive drugs. These three interventions were not compared head-to-head."
}
]
|
query-laysum | 4057 | [
{
"role": "user",
"content": "Abstract: Background\nPeople who have chronic kidney disease (CKD) have important changes to bone structure, strength, and metabolism. Children experience bone deformity, pain, and delayed or impaired growth. Adults experience limb and vertebral fractures, avascular necrosis, and pain. The fracture risk after kidney transplantation is four times that of the general population and is related to Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) occurring with end-stage kidney failure, steroid-induced bone loss, and persistent hyperparathyroidism after transplantation. Fractures may reduce quality of life and lead to being unable to work or contribute to community roles and responsibilities. Earlier versions of this review have found low certainty evidence for effects of treatment. This is an update of a review first published in 2005 and updated in 2007.\nObjectives\nThis review update evaluates the benefits and harms of interventions for preventing bone disease following kidney transplantation.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 16 May 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRCTs and quasi-RCTs evaluating treatments for bone disease among kidney transplant recipients of any age were eligible.\nData collection and analysis\nTwo authors independently assessed trial risks of bias and extracted data. Statistical analyses were performed using random effects meta-analysis. The risk estimates were expressed as a risk ratio (RR) for dichotomous variables and mean difference (MD) for continuous outcomes together with the corresponding 95% confidence interval (CI). The primary efficacy outcome was bone fracture. The primary safety outcome was acute graft rejection. Secondary outcomes included death (all cause and cardiovascular), myocardial infarction, stroke, musculoskeletal disorders (e.g. skeletal deformity, bone pain), graft loss, nausea, hyper- or hypocalcaemia, kidney function, serum parathyroid hormone (PTH), and bone mineral density (BMD).\nMain results\nIn this 2019 update, 65 studies (involving 3598 participants) were eligible; 45 studies contributed data to our meta-analyses (2698 participants). Treatments included bisphosphonates, vitamin D compounds, teriparatide, denosumab, cinacalcet, parathyroidectomy, and calcitonin. Median duration of follow-up was 12 months. Forty-three studies evaluated bone density or bone-related biomarkers, with more recent studies evaluating proteinuria and hyperparathyroidism. Bisphosphonate therapy was usually commenced in the perioperative transplantation period (within 3 weeks) and regardless of BMD. Risks of bias were generally high or unclear leading to lower certainty in the results. A single study reported outcomes among 60 children and adolescents. Studies were not designed to measure treatment effects on fracture, death or cardiovascular outcomes, or graft loss.\nCompared to placebo, bisphosphonate therapy administered over 12 months in transplant recipients may prevent fracture (RR 0.62, 95% CI 0.38 to 1.01; low certainty evidence) although the 95% CI included the possibility that bisphosphonate therapy might make little or no difference. Fracture events were principally vertebral fractures identified during routine radiographic surveillance. It was uncertain whether any other drug class decreased fracture (low or very low certainty evidence). It was uncertain whether interventions for bone disease in kidney transplantation reduce all-cause or cardiovascular death, myocardial infarction or stroke, or graft loss in very low certainty evidence. Bisphosphonate therapy may decrease acute graft rejection (RR 0.70, 95% CI 0.55 to 0.89; low certainty evidence), while it is uncertain whether any other treatment impacts graft rejection (very low certainty evidence). Bisphosphonate therapy may reduce bone pain (RR 0.20, 95% CI 0.04 to 0.93; very low certainty evidence), while it was very uncertain whether bisphosphonates prevent spinal deformity or avascular bone necrosis (very low certainty evidence). Bisphosphonates may increase to risk of hypocalcaemia (RR 5.59, 95% CI 1.00 to 31.06; low certainty evidence). It was uncertain whether vitamin D compounds had any effect on skeletal, cardiovascular, death, or transplant function outcomes (very low certainty or absence of evidence). Evidence for the benefits and harms of all other treatments was of very low certainty. Evidence for children and young adolescents was sparse.\nAuthors' conclusions\nBisphosphonate therapy may reduce fracture and bone pain after kidney transplantation, however low certainty in the evidence indicates it is possible that treatment may make little or no difference. It is uncertain whether bisphosphonate therapy or other bone treatments prevent other skeletal complications after kidney transplantation, including spinal deformity or avascular bone necrosis. The effects of bone treatment for children and adolescents after kidney transplantation are very uncertain.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who have a kidney transplant can have more fragile bones because of changes to the ways bones are formed in kidney disease and because anti-rejection medicines including prednisone can make their bones thinner. Bone fractures can cause difficulty with walking and carrying out the activities of everyday living such as work and family life. There are several treatment options for preventing fracture for people with thinner bones but whether these are helpful for kidney transplant patients is not clear. An earlier version of this Cochrane review in 2004 (and updated in 2007) did not find that any of these treatments prevented fractures."
}
]
|
query-laysum | 4058 | [
{
"role": "user",
"content": "Abstract: Background\nThe impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.\nObjectives\nTo assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component).\nSearch methods\nWe searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020.\nSelection criteria\nWe included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included.\nData collection and analysis\nTwo review authors independently extracted data. We assessed the risk of systematic errors (‘bias’) by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life).\nMain results\nWe included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns.\nFollow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low).\nAuthors' conclusions\nDue to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.\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 from this Review should be interpreted with caution because of some concerns about risk of bias (potential for systematic error) in five out of six trials. Only one trial had low risk of bias. Additional high-quality randomised controlled trials are needed to fully assess the effects of exercise-based CR interventions."
}
]
|
query-laysum | 4059 | [
{
"role": "user",
"content": "Abstract: Background\nInsomnia disorder is a subjective condition of unsatisfactory sleep (e.g. sleep onset, maintenance, early waking, impairment of daytime functioning). Insomnia disorder impairs quality of life and is associated with an increased risk of physical and mental health problems including anxiety, depression, drug and alcohol abuse, and increased health service use. hypnotic medications (e.g. benzodiazepines and 'Z' drugs) are licensed for sleep promotion, but can induce tolerance and dependence, although many people remain on long-term treatment. Antidepressant use for insomnia is widespread, but none is licensed for insomnia and the evidence for their efficacy is unclear. This use of unlicensed medications may be driven by concern over longer-term use of hypnotics and the limited availability of psychological treatments.\nObjectives\nTo assess the effectiveness, safety and tolerability of antidepressants for insomnia in adults.\nSearch methods\nThis review incorporated the results of searches to July 2015 conducted on electronic bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 6), MEDLINE (1950 to 2015), Embase (1980 to 2015) and PsycINFO (1806 to 2015). We updated the searches to December 2017, but these results have not yet been incorporated into the review.\nSelection criteria\nRandomised controlled trials (RCTs) of adults (aged 18 years or older) with a primary diagnosis of insomnia and all participant types including people with comorbidities. Any antidepressant as monotherapy at any dose whether compared with placebo, other medications for insomnia (e.g. benzodiazepines and 'Z' drugs), a different antidepressant, waiting list control or treatment as usual.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and extracted data using a data extraction form. A third review author resolved disagreements on inclusion or data extraction.\nMain results\nThe search identified 23 RCTs (2806 participants).\nSelective serotonin reuptake inhibitors (SSRIs) compared with placebo: three studies (135 participants) compared SSRIs with placebo. Combining results was not possible. Two paroxetine studies showed significant improvements in subjective sleep measures at six (60 participants, P = 0.03) and 12 weeks (27 participants, P < 0.001). There was no difference in the fluoxetine study (low quality evidence).\nThere were either no adverse events or they were not reported (very low quality evidence).\nTricyclic antidepressants (TCA) compared with placebo: six studies (812 participants) compared TCA with placebo; five used doxepin and one used trimipramine. We found no studies of amitriptyline. Four studies (518 participants) could be pooled, showing a moderate improvement in subjective sleep quality over placebo (standardised mean difference (SMD) -0.39, 95% confidence interval (CI) -0.56 to -0.21) (moderate quality evidence). Moderate quality evidence suggested that TCAs possibly improved sleep efficiency (mean difference (MD) 6.29 percentage points, 95% CI 3.17 to 9.41; 4 studies; 510 participants) and increased sleep time (MD 22.88 minutes, 95% CI 13.17 to 32.59; 4 studies; 510 participants). There may have been little or no impact on sleep latency (MD -4.27 minutes, 95% CI -9.01 to 0.48; 4 studies; 510 participants).\nThere may have been little or no difference in adverse events between TCAs and placebo (risk ratio (RR) 1.02, 95% CI 0.86 to 1.21; 6 studies; 812 participants) (low quality evidence).\n'Other' antidepressants with placebo: eight studies compared other antidepressants with placebo (one used mianserin and seven used trazodone). Three studies (370 participants) of trazodone could be pooled, indicating a moderate improvement in subjective sleep outcomes over placebo (SMD -0.34, 95% CI -0.66 to -0.02). Two studies of trazodone measured polysomnography and found little or no difference in sleep efficiency (MD 1.38 percentage points, 95% CI -2.87 to 5.63; 169 participants) (low quality evidence).\nThere was low quality evidence from two studies of more adverse effects with trazodone than placebo (i.e. morning grogginess, increased dry mouth and thirst).\nAuthors' conclusions\nWe identified relatively few, mostly small studies with short-term follow-up and design limitations. The effects of SSRIs compared with placebo are uncertain with too few studies to draw clear conclusions. There may be a small improvement in sleep quality with short-term use of low-dose doxepin and trazodone compared with placebo. The tolerability and safety of antidepressants for insomnia is uncertain due to limited reporting of adverse events. There was no evidence for amitriptyline (despite common use in clinical practice) or for long-term antidepressant use for insomnia. High-quality trials of antidepressants for insomnia are needed.\n\nGiven the provided abstract, please respond to the following query: \"What did the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed 23 studies with 2806 people with insomnia. Overall, the quality of the evidence was low due to a small number of people in the studies, and problems with how the studies were undertaken and reported. We often could not combine the individual study results. There was low quality evidence to support short-term (i.e. weeks rather than months) use for some antidepressants. There was no evidence for the antidepressant amitriptyline, which is commonly used in clinical practice, or to support long-term antidepressant use for insomnia. The evidence did not support the clinical current practice of prescribing antidepressants for insomnia."
}
]
|
query-laysum | 4060 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic floor muscle training (PFMT) is a first-line conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g. vaginal cones); behavioural therapies (e.g. bladder training); electrical or magnetic stimulation; mechanical devices (e.g. continence pessaries); drug therapies (e.g. anticholinergics (solifenacin, oxybutynin, etc.) and duloxetine); and surgical interventions including sling procedures and colposuspension. This systematic review evaluated the effects of adding PFMT to any other active treatment for urinary incontinence in women\nObjectives\nTo compare the effects of pelvic floor muscle training combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and CINAHL (January 1982 to 6 May 2015), and the reference lists of relevant articles.\nSelection criteria\nWe included randomised or quasi-randomised trials with two or more arms, of women with clinical or urodynamic evidence of stress urinary incontinence, urgency urinary incontinence or mixed urinary incontinence. One arm of the trial included PFMT added to another active treatment; the other arm included the same active treatment alone.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and methodological quality and resolved any disagreement by discussion or consultation with a third party. We extracted and processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Other potential sources of bias we incorporated into the 'Risk of bias' tables were ethical approval, conflict of interest and funding source.\nMain results\nThirteen trials met the inclusion criteria, comprising women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI) or mixed urinary incontinence (MUI); they compared PFMT added to another active treatment (585 women) with the same active treatment alone (579 women). The pre-specified comparisons were reported by single trials, except bladder training, which was reported by two trials, and electrical stimulation, which was reported by three trials. However, only two of the three trials reporting electrical stimulation could be pooled, as one of the trials did not report any relevant data. We considered the included trials to be at unclear risk of bias for most of the domains, predominantly due to the lack of adequate information in a number of trials. This affected our rating of the quality of evidence.\nThe majority of the trials did not report the primary outcomes specified in the review (cure or improvement, quality of life) or measured the outcomes in different ways. Effect estimates from small, single trials across a number of comparisons were indeterminate for key outcomes relating to symptoms, and we rated the quality of evidence, using the GRADE approach, as either low or very low. More women reported cure or improvement of incontinence in two trials comparing PFMT added to electrical stimulation to electrical stimulation alone, in women with SUI, but this was not statistically significant (9/26 (35%) versus 5/30 (17%); risk ratio (RR) 2.06, 95% confidence interval (CI) 0.79 to 5.38). We judged the quality of the evidence to be very low. There was moderate-quality evidence from a single trial investigating women with SUI, UUI or MUI that a higher proportion of women who received a combination of PFMT and heat and steam generating sheet reported a cure compared to those who received the sheet alone: 19/37 (51%) versus 8/37 (22%) with a RR of 2.38, 95% CI 1.19 to 4.73). More women reported cure or improvement of incontinence in another trial comparing PFMT added to vaginal cones to vaginal cones alone, but this was not statistically significant (14/15 (93%) versus 14/19 (75%); RR 1.27, 95% CI 0.94 to 1.71). We judged the quality of the evidence to be very low. Only one trial evaluating PFMT when added to drug therapy provided information about adverse events (RR 0.84, 95% CI 0.45 to 1.60; very low-quality evidence).\nWith regard to condition-specific quality of life, there were no statistically significant differences between women (with SUI, UUI or MUI) who received PFMT added to bladder training and those who received bladder training alone at three months after treatment, on either the Incontinence Impact Questionnaire-Revised scale (mean difference (MD) -5.90, 95% CI -35.53 to 23.73) or on the Urogenital Distress Inventory scale (MD -18.90, 95% CI -37.92 to 0.12). A similar pattern of results was observed between women with SUI who received PFMT plus either a continence pessary or duloxetine and those who received the continence pessary or duloxetine alone. In all these comparisons, the quality of the evidence for the reported critical outcomes ranged from moderate to very low.\nAuthors' conclusions\nThis systematic review found insufficient evidence to state whether or not there were additional effects by adding PFMT to other active treatments when compared with the same active treatment alone for urinary incontinence (SUI, UUI or MUI) in women. These results should be interpreted with caution as most of the comparisons were investigated in small, single trials. None of the trials in this review were large enough to provide reliable evidence. Also, none of the included trials reported data on adverse events associated with the PFMT regimen, thereby making it very difficult to evaluate the safety of PFMT.\n\nGiven the provided abstract, please respond to the following query: \"Limitations of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most of the comparisons were investigated by single trials, which were small. None of the trials included in this systematic review were large enough to answer the questions they were designed to answer. The quality of the evidence was rated as either low or very low for the outcomes of interest. The main limitations of the evidence were poor reporting of study methods, and lack of precision in the findings for the outcome measures."
}
]
|
query-laysum | 4061 | [
{
"role": "user",
"content": "Abstract: Background\nFluid therapy is one of the main interventions provided for critically ill patients, although there is no general consensus regarding the type of solution. Among crystalloid solutions, 0.9% saline is the most commonly administered. Buffered solutions may offer some theoretical advantages (less metabolic acidosis, less electrolyte disturbance), but the clinical relevance of these remains unknown.\nObjectives\nTo assess the effects of buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children.\nSearch methods\nWe searched the following databases to July 2018: CENTRAL, MEDLINE, Embase, CINAHL, and four trials registers. We checked references, conducted backward and forward citation searching of relevant articles, and contacted study authors to identify additional studies. We imposed no language restrictions.\nSelection criteria\nWe included randomized controlled trials (RCTs) with parallel or cross-over design examining buffered solutions versus intravenous 0.9% saline in a critical care setting (resuscitation or maintenance). We included studies on participants with critical illness (including trauma and burns) or undergoing emergency surgery during critical illness who required intravenous fluid therapy. We included studies of adults and children. We included studies with more than two arms if they fulfilled all of our inclusion criteria. We excluded studies performed in persons undergoing elective surgery and studies with multiple interventions in the same arm.\nData collection and analysis\nWe used Cochrane's standard methodological procedures. We assessed our intervention effects using random-effects models, but when one or two trials contributed to 75% of randomized participants, we used fixed-effect models. We reported outcomes with 95% confidence intervals (CIs).\nMain results\nWe included 21 RCTs (20,213 participants) and identified three ongoing studies. Three RCTs contributed 19,054 participants (94.2%). Four RCTs (402 participants) were conducted among children with severe dehydration and dengue shock syndrome. Fourteen trials reported results on mortality, and nine reported on acute renal injury. Sixteen included trials were conducted in adults, four in the paediatric population, and one trial limited neither minimum or maximum age as an inclusion criterion. Eight studies involving 19,218 participants were rated as high methodological quality (trials with overall low risk of bias according to the domains: allocation concealment, blinding of participants/assessors, incomplete outcome data, and selective reporting), and in the remaining trials, some form of bias was introduced or could not be ruled out.\nWe found no evidence of an effect of buffered solutions on in-hospital mortality (odds ratio (OR) 0.91, 95% CI 0.83 to 1.01; 19,664 participants; 14 studies; high-certainty evidence). Based on a mortality rate of 119 per 1000, buffered solutions could reduce mortality by 21 per 1000 or could increase mortality by 1 per 1000. Similarly, we found no evidence of an effect of buffered solutions on acute renal injury (OR 0.92, 95% CI 0.84 to 1.00; 18,701 participants; 9 studies; low-certainty evidence). Based on a rate of 121 per 1000, buffered solutions could reduce the rate of acute renal injury by 19 per 1000, or result in no difference in the rate of acute renal injury. Buffered solutions did not show an effect on organ system dysfunction (OR 0.80, 95% CI 0.40 to 1.61; 266 participants; 5 studies; very low-certainty evidence). Evidence on the effects of buffered solutions on electrolyte disturbances varied: potassium (mean difference (MD) 0.09, 95% CI -0.10 to 0.27; 158 participants; 4 studies; very low-certainty evidence); chloride (MD -3.02, 95% CI -5.24 to -0.80; 351 participants; 7 studies; very low-certainty evidence); pH (MD 0.04, 95% CI 0.02 to 0.06; 200 participants; 3 studies; very low-certainty evidence); and bicarbonate (MD 2.26, 95% CI 1.25 to 3.27; 344 participants; 6 studies; very low-certainty evidence).\nAuthors' conclusions\nWe found no effect of buffered solutions on preventing in-hospital mortality compared to 0.9% saline solutions in critically ill patients. The certainty of evidence for this finding was high, indicating that further research would detect little or no difference in mortality. The effects of buffered solutions and 0.9% saline solutions on preventing acute kidney injury were similar in this setting. The certainty of evidence for this finding was low, and further research could change this conclusion. Patients treated with buffered solutions showed lower chloride levels, higher levels of bicarbonate, and higher pH. The certainty of evidence for these findings was very low. Future research should further examine patient-centred outcomes such as quality of life. The three ongoing studies once published and assessed may alter the conclusions of the review.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that had been published up to July 2018."
}
]
|
query-laysum | 4062 | [
{
"role": "user",
"content": "Abstract: Background\nAlcohol withdrawal syndrome (AWS) is a distressing and life-threatening condition that usually affects people who are alcohol dependent when they discontinue or decrease their alcohol consumption. Baclofen shows potential for rapidly reducing symptoms of severe AWS in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane Review first published in 2011 and last updated in 2017.\nObjectives\nTo assess the efficacy and safety of baclofen for people with AWS.\nSearch methods\nWe updated our searches of the following databases to June 2019: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, PubMed, Embase, and CINAHL. We also searched registers of ongoing trials. We handsearched the references quoted in the identified trials, and sought information from researchers, pharmaceutical companies, and relevant trial authors about unpublished or uncompleted trials. We placed no restrictions on language.\nSelection criteria\nWe included all randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for people with AWS. We excluded uncontrolled, non-randomised, or quasi-randomised trials. We included both parallel group and cross-over studies.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included four RCTs with 189 randomised participants (one RCT new for this update). None of the included studies reported the primary outcomes of alcohol withdrawal seizures, alcohol withdrawal delirium, or craving.\nFor the comparison of baclofen and placebo (1 study, 31 participants), there was no evidence of a difference in Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores in eight-hour periods from days one to five (very low-quality evidence).\nFor the comparison of baclofen and diazepam (2 studies, 85 participants), there was no evidence of a difference in change from baseline to days 10 to 15 on CIWA-Ar scores (very low-quality evidence, meta-analysis was not performed due to insufficient data). In one study (37 participants), there was no evidence of a difference in participants with at least one adverse event (risk difference (RD) 0.00, 95% confidence interval (CI) –0.10 to 0.10; very low-quality evidence), dropouts (RD 0.00, 95% CI –0.10 to 0.10; very low-quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI –0.10 to 0.10; very low-quality evidence).\nFor the comparison of baclofen and chlordiazepoxide (1 study, 60 participants), there was no evidence of a difference in difference from baseline to nine-day decremental fixed-dose intervention: CIWA-Ar scores (mean difference (MD) 1.00, 95% CI 0.70 to 1.30; very low-quality evidence), global improvement (MD 0.10, 95% CI –0.03 to 0.23; very low-quality evidence), 14/60 participants with adverse events (RD 2.50, 95% CI 0.88 to 7.10; very low-quality of evidence), dropouts (RD 0.00, 95% CI –0.06 to 0.06; very low-quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI –0.06 to 0.06; very low-quality evidence). None of the RCTs provided information on random sequence generation or allocation concealment, therefore, we assessed them at unclear risk of bias. Two RCTs were not of double-blind design and had a high risk of bias in blinding (Addolorato 2006; Girish 2016). One RCT had more than 5% dropouts with high risk of attrition bias (Lyon 2011). We could not assess reporting bias as none of the prepublished protocols were available.\nAuthors' conclusions\nNo conclusions can be drawn about the efficacy and safety of baclofen for the management of alcohol withdrawal because we found insufficient and very low-quality evidence.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review attempted to evaluate the efficacy and safety of baclofen as a therapy for alcohol withdrawal syndrome (AWS) in people with alcoholism."
}
]
|
query-laysum | 4063 | [
{
"role": "user",
"content": "Abstract: Background\nA large subgroup of people with interstitial lung disease (ILD) are normoxic at rest, but rapidly desaturate on exertion. This can limit exercise capacity and worsen dyspnoea. The use of ambulatory or short-burst oxygen when mobilising or during other activities, may improve exercise capacity and relieve dyspnoea.\nObjectives\nTo determine the effects of ambulatory and short-burst oxygen therapy, separately, on exercise capacity, dyspnoea and quality of life in people who have interstitial lung disease (ILD), particularly those with idiopathic pulmonary fibrosis (IPF).\nSearch methods\nWe conducted searches in the Cochrane Airways Group Specialised Register (all years to May 2016), Cochrane Central Register of Controlled Trials (CENTRAL) (all years to May 2016), MEDLINE (Ovid) (1950 to 4th May 2016) and EMBASE (Ovid) (1974 to 4th May 2016). We also searched the reference lists of relevant studies, international clinical trial registries and respiratory conference abstracts for studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that compared ambulatory or short-burst oxygen with a control group in people with ILD of any origin.\nData collection and analysis\nTwo review authors independently selected studies for inclusion and assessed risk of bias in the included studies. We extracted data from included studies using a prepared checklist, including study characteristics and results. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to assess the quality of the included studies.\nMain results\nThree studies (including 98 participants, all of whom had IPF) met the inclusion criteria of this review. These studies were conducted in hospital respiratory physiology laboratories. Two studies did not demonstrate any beneficial effect of supplemental oxygen on exercise capacity or exertional dyspnoea. Neither of these studies titrated oxygen requirements to prevent ongoing exertional desaturation. One study showed an increase in exercise capacity as assessed by endurance time with supplemental oxygen. We did not identify any studies that examined the effect of ambulatory oxygen on health-related quality of life, survival, costs or time to exacerbation or hospitalisation. No study reported any adverse events. The quality of evidence for all three studies, as assessed by GRADE criteria, was low.\nAuthors' conclusions\nThis review found no evidence to support or refute the use of ambulatory or short burst oxygen in ILD due to the limited number of included studies and data. Further research is needed to examine the role of this 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": "Should oxygen be used for people with lung scarring conditions, known as interstitial lung disease (ILD), whose oxygen levels drop when they exercise?"
}
]
|
query-laysum | 4064 | [
{
"role": "user",
"content": "Abstract: Background\nDay surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy.\nObjectives\nTo compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013).\nSelection criteria\nWe included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status).\nData collection and analysis\nTwo authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis.\nMain results\nWe included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials.\nAuthors' conclusions\nThere is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.\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": "Randomized controlled trials designed to minimize the risk of arriving at wrong conclusions are necessary to determine the best anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world."
}
]
|
query-laysum | 4065 | [
{
"role": "user",
"content": "Abstract: Background\nIt is generally accepted that taxanes are among the most active chemotherapy agents in the management of metastatic breast cancer. This is an update of a Cochrane review first published in 2003.\nObjectives\nThe objective of this review was to compare taxane-containing chemotherapy regimens with regimens not containing a taxane in the management of women with metastatic breast cancer.\nSearch methods\nIn this review update, we searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE, EMBASE, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 14 February 2013 using keywords such as 'advanced breast cancer' and 'chemotherapy'. We searched reference lists of articles, contacted study authors, and did not apply any language restrictions.\nSelection criteria\nRandomised controlled trials comparing taxane-containing chemotherapy regimens to regimens without taxanes in women with metastatic breast cancer. We included published and unpublished studies.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We derived hazard ratios (HRs) for overall survival, time to progression, and time to treatment failure where possible, and used a fixed-effect model for meta-analysis. We represented objective tumour response rates and toxicity as risk ratios (RRs). We extracted quality of life data where present.\nMain results\nThis review included 28 studies. The updated analysis included 6871 randomised women, while the original review had 3643 women. Of the 28 included studies, we considered 19 studies to be at low risk of bias overall; however, some studies failed to report details on allocation concealment and methods of outcome assessment for those outcomes that are more likely to be influenced by a lack of blinding (for example tumour response rate). Studies varied in the taxane-containing chemotherapy backbone, and the comparator arms and were categorised into three groups: Regimen A plus taxane versus Regimen A (2 studies); Regimen A plus taxane versus Regimen B (14 studies); and single-agent taxane versus Regimen C (13 studies). Thirteen studies used paclitaxel, 14 studies used docetaxel, and 1 study allowed the investigator to decide on the type of taxane; the majority of studies delivered a taxane every 3 weeks. Twenty studies administered taxanes as first-line treatment, and 21 studies involved anthracycline naïve women in the metastatic setting. The combined HR for overall survival and time to progression favoured the taxane-containing regimens (HR 0.93, 95% confidence interval (CI) 0.88 to 0.99, P = 0.002, deaths = 4477; and HR 0.92, 95% CI 0.87 to 0.97, P = 0.002, estimated 5122 events, respectively) with moderate to substantial heterogeneity across trials. If the analyses were restricted to studies of first-line chemotherapy, this effect persisted for overall survival (HR 0.93, 95% CI 0.87 to 0.99, P = 0.03) but not for time to progression (HR 0.96, 95% CI 0.90 to 1.02, P = 0.22). Tumour response rates appeared to be better with taxane-containing chemotherapy in assessable women (RR 1.20, 95% CI 1.14 to 1.27, P < 0.00001) with substantial heterogeneity across studies. Taxanes were associated with an increased risk of neurotoxicity (RR 4.84, 95% CI 3.18 to 7.35, P < 0.00001, 24 studies) and hair loss (RR 2.37, 95% CI 1.45 to 3.87, P = 0.0006, 11 studies) but less nausea/vomiting compared to non-taxane-containing regimens (RR 0.62, 95% CI 0.46 to 0.83, P = 0.001, 26 studies). Leukopaenia and treatment-related death did not differ between the two groups (RR 1.07, 95% CI 0.97 to 1.17, P = 0.16, 28 studies; and RR 1.00, 95% CI 0.63 to 1.57, P = 0.99, 23 studies, respectively). For quality of life measures, none of the individual studies reported a difference in overall or any of quality of life subscales between taxane-containing and non-taxane chemotherapy regimens.\nAuthors' conclusions\nTaxane-containing regimens appear to improve overall survival, time to progression, and tumour response rate in women with metastatic breast cancer. Taxanes are also associated with an increased risk of neurotoxicity but less nausea and vomiting compared to non-taxane-containing regimens. The considerable heterogeneity encountered across studies probably reflects the varying efficacy of the comparator regimens used in these studies and indicates that taxane-containing regimens are more effective than some, but not all, non-taxane-containing regimens.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Treatment for women with metastatic breast cancer (that is, cancer that has spread beyond the breast) usually involves chemotherapy to try to shrink or slow the growth of the cancer. Chemotherapy can involve a single drug or a combination of drugs. Paclitaxel and docetaxel are chemotherapy drugs known as taxanes. Taxanes can inhibit cancer cells from dividing and reproducing, and their adverse effects can include nausea, vomiting, and hair loss, as well as allergic reactions, which can be reduced by premedication. We wanted to examine whether or not taxane-containing chemotherapy improves survival and extends time to disease progression in women with metastatic breast cancer."
}
]
|
query-laysum | 4066 | [
{
"role": "user",
"content": "Abstract: Background\nMirror therapy is used to improve motor function after stroke. During mirror therapy, a mirror is placed in the person's midsagittal plane, thus reflecting movements of the non-paretic side as if it were the affected side.\nObjectives\nTo summarise the effectiveness of mirror therapy compared with no treatment, placebo or sham therapy, or other treatments for improving motor function and motor impairment after stroke. We also aimed to assess the effects of mirror therapy on activities of daily living, pain, and visuospatial neglect.\nSearch methods\nWe searched the Cochrane Stroke Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED, PsycINFO and PEDro (last searched 16 August 2017). We also handsearched relevant conference proceedings, trials and research registers, checked reference lists, and contacted trialists, researchers and experts in our field of study.\nSelection criteria\nWe included randomised controlled trials (RCTs) and randomised cross-over trials comparing mirror therapy with any control intervention for people after stroke.\nData collection and analysis\nTwo review authors independently selected trials based on the inclusion criteria, documented the methodological quality, assessed risks of bias in the included studies, and extracted data. We assessed the quality of the evidence using the GRADE approach. We analysed the results as standardised mean differences (SMDs) or mean differences (MDs) for continuous variables, and as odds ratios (ORs) for dichotomous variables.\nMain results\nWe included 62 studies with a total of 1982 participants that compared mirror therapy with other interventions. Of these, 57 were randomised controlled trials and five randomised cross-over trials. Participants had a mean age of 59 years (30 to 73 years). Mirror therapy was provided three to seven times a week, between 15 and 60 minutes for each session for two to eight weeks (on average five times a week, 30 minutes a session for four weeks).When compared with all other interventions, we found moderate-quality evidence that mirror therapy has a significant positive effect on motor function (SMD 0.47, 95% CI 0.27 to 0.67; 1173 participants; 36 studies) and motor impairment (SMD 0.49, 95% CI 0.32 to 0.66; 1292 participants; 39 studies). However, effects on motor function are influenced by the type of control intervention. Additionally, based on moderate-quality evidence, mirror therapy may improve activities of daily living (SMD 0.48, 95% CI 0.30 to 0.65; 622 participants; 19 studies). We found low-quality evidence for a significant positive effect on pain (SMD −0.89, 95% CI −1.67 to −0.11; 248 participants; 6 studies) and no clear effect for improving visuospatial neglect (SMD 1.06, 95% CI −0.10 to 2.23; 175 participants; 5 studies). No adverse effects were reported.\nAuthors' conclusions\nThe results indicate evidence for the effectiveness of mirror therapy for improving upper extremity motor function, motor impairment, activities of daily living, and pain, at least as an adjunct to conventional rehabilitation for people after stroke. Major limitations are small sample sizes and lack of reporting of methodological details, resulting in uncertain evidence quality.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does mirror therapy improve movement, the performance of daily activities, pain, and lack of attention to and awareness of the affected field of vision (visuospatial neglect) after stroke."
}
]
|
query-laysum | 4067 | [
{
"role": "user",
"content": "Abstract: Background\nCombined modality treatment consisting of chemotherapy followed by localised radiotherapy is the standard treatment for patients with early stage Hodgkin lymphoma (HL). However, due to long- term adverse effects such as secondary malignancies the role of radiotherapy has been questioned recently and some clinical study groups advocate chemotherapy only for this indication.\nObjectives\nTo assess the effects of chemotherapy alone compared to chemotherapy plus radiotherapy in adults with early stage HL .\nSearch methods\nFor the or i ginal version of this review, we searched MEDLINE, Embase and CENTRAL as well as conference proceedings (American Society of Hematology, American Society of Clinical Oncology and International Symposium of Hodgkin Lymphoma) from January 1980 to November 2010 for randomised controlled trials (RCTs) comparing chemotherapy alone versus chemotherapy regimens plus radiotherapy. For the updated review we searched MEDLINE, CENTRAL and conference proceedings to December 2016.\nSelection criteria\nWe included RCTs comparing chemotherapy alone with chemotherapy plus radiotherapy in patients with early stage HL. We excluded trials with more than 20% of patients in advanced stage. As the value of radiotherapy in addition to chemotherapy is still not clear, we also compared to more cycles of chemotherapy in the control arm. In this updated review, we also included a second comparison evaluating trials with varying numbers of cycles of chemotherapy between intervention and control arms, same chemotherapy regimen in both arms assumed. We excluded trials evaluating children only, therefore only trials involving adults are included in this updated review.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of trials. We contacted study authors to obtain missing information. As effect measures we used hazard ratios (HR) for overall survival (OS) and progression-free survival (PFS) and risk ratios (RR) for response rates. Since not all trials reported PFS according to our definitions, we evaluated all similar outcomes (e.g. event-free survival) as PFS/tumour control.\nMain results\nOur search led to 5518 potentially relevant references. From these, we included seven RCTs in the analyses involving 2564 patients. In contrast to the first version of this review including five trials, we excluded trials randomising children. As a result, we excluded one trial from the former analyses and we identified three new trials.\nFive trials with 1388 patients compared the combination of chemotherapy alone and chemotherapy plus radiotherapy, with the same number of chemotherapy cycles in both arms. The addition of radiotherapy to chemotherapy has probably little or no difference on OS (HR 0.48; 95% confidence interval (CI) 0.22 to 1.06; P = 0.07, moderate- quality evidence), however two included trials had potential other high risk of bias due to a high number of patients not receiving planned radiotherapy. After excluding these trials in a sensitivity analysis, the results showed that the combination of chemotherapy and radiotherapy improved OS compared to chemotherapy alone (HR 0.31; 95% CI 0.19 to 0.52; P <0.00001, moderate- quality evidence). In contrast to chemotherapy alone the use of chemotherapy and radiotherapy improved PFS (HR 0.42; 95% CI 0.25 to 0.72; P = 0.001; moderate- quality evidence). Regarding infection- related mortality (RR 0.33; 95% CI 0.01 to 8.06; P = 0.5; low- quality evidence), second cancer- related mortality (RR 0.53; 95% CI 0.07 to 4.29; P = 0.55; low- quality evidence) and cardiac disease- related mortality (RR 2.94; 95% CI 0.31 to 27.55; P = 0.35;low- quality evidence), there is no evidence for a difference between the use of chemotherapy alone and chemotherapy plus radiotherapy. For complete response rate (CRR) (RR 1.08; 95% CI 0.93 to 1.25; P = 0.33; low- quality evidence), there is also no evidence for a difference between treatment groups.\nTwo trials with 1176 patients compared the combination of chemotherapy alone and chemotherapy plus radiotherapy, with different numbers of chemotherapy cycles in both arms. OS is reported in one trial only, the use of chemotherapy alone (more chemotherapy cycles) may improve OS compared to chemotherapy plus radiotherapy (HR 2.12; 95% CI 1.03 to 4.37; P = 0.04; low- quality evidence). This trial also had a potential other high risk of bias due to a high number of patients not receiving planned therapy. There is no evidence for a difference between chemotherapy alone and chemotherapy plus radiotherapy regarding PFS (HR 0.42; 95% CI 0.14 to 1.24; P = 0.12; low- quality evidence). After excluding the trial with patients not receiving the planned therapy in a sensitivity analysis, the results showed that the combination of chemotherapy and radiotherapy improved PFS compared to chemotherapy alone (HR 0.24; 95% CI 0.070 to 0.88; P = 0.03, based on one trial). For infection- related mortality (RR 6.90; 95% CI 0.36 to 132.34; P = 0.2; low- quality evidence), second cancer- related mortality (RR 2.22; 95% CI 0.7 to 7.03; P = 0.18; low- quality evidence) and cardiac disease-related mortality (RR 0.99; 95% CI 0.14 to 6.90; P = 0.99; low-quality evidence), there is no evidence for a difference between the use of chemotherapy alone and chemotherapy plus radiotherapy. CRR rate was not reported.\nAuthors' conclusions\nThis systematic review compared the effects of chemotherapy alone and chemotherapy plus radiotherapy in adults with early stage HL .\nFor the comparison with same numbers of chemotherapy cycles in both arms, we found moderate- quality evidence that PFS is superior in patients receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. The addition of radiotherapy to chemotherapy has probably little or no difference on OS . The sensitivity analysis without the trials with potential other high risk of bias showed that chemotherapy plus radiotherapy improves OS compared to chemotherapy alone.\nFor the comparison with different numbers of chemotherapy cycles between the arms there are no implications for OS and PFS possible, because of the low quality of evidence of the results.\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": "This systematic review compared the effects of chemotherapy alone and chemotherapy plus radiotherapy in adults with early stage HL .\nFor the comparison with same numbers of chemotherapy cycles in both arms we found moderate- quality evidence that PFS is superior in patients receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. The addition of radiotherapy to chemotherapy has probably little or no difference on OS. A further analysis without the trials with potential other high risk of bias showed that chemotherapy plus radiotherapy improves OS (both analyses moderate- quality evidence).\nFor the comparison of chemotherapy alone and chemotherapy plus radiotherapy with different numbers of chemotherapy cycles between the arms there were no implications for OS and PFS possible, because of the low quality of evidence of the results."
}
]
|
query-laysum | 4068 | [
{
"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: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our analysis showed that in good grade patients, it remains possible that cooling the brain during surgery might prevent death or dependency in everyday activities. Very limited information was available for those without bleeding or those with poor grade bleeding. Unfavourable outcomes did not differ between participants with or without hypothermia. The quality of evidence for these outcomes remains unclear because they were reported in a variety of ways."
}
]
|
query-laysum | 4069 | [
{
"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: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "An updated search for relevant randomised controlled trials was run in October 2014, and again, in December 2016 and found one new study. Five studies have now been found that meet the review inclusion criteria. The included studies are all randomised, and investigate the effects of giving different doses of chlorpromazine to people with schizophrenia. The total number of participants was 585."
}
]
|
query-laysum | 4070 | [
{
"role": "user",
"content": "Abstract: Background\nPatients treated with mechanical ventilation in intensive care units (ICUs) have a high risk of developing respiratory tract infections (RTIs). Ventilator-associated pneumonia (VAP) has been estimated to affect 5% to 40% of patients treated with mechanical ventilation for at least 48 hours. The attributable mortality rate of VAP has been estimated at about 9%. Selective digestive decontamination (SDD), which consists of the topical application of non-absorbable antimicrobial agents to the oropharynx and gastroenteric tract during the whole period of mechanical ventilation, is often used to reduce the risk of VAP. A related treatment is selective oropharyngeal decontamination (SOD), in which topical antibiotics are applied to the oropharynx only. This is an update of a review first published in 1997 and updated in 2002, 2004, and 2009.\nObjectives\nTo assess the effect of topical antibiotic regimens (SDD and SOD), given alone or in combination with systemic antibiotics, to prevent mortality and respiratory infections in patients receiving mechanical ventilation for at least 48 hours in ICUs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections (ARI) Group's Specialised Register, PubMed, and Embase on 5 February 2020. We also searched the WHO ICTRP and ClinicalTrials.gov for ongoing and unpublished studies on 5 February 2020. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs assessing the efficacy and safety of topical prophylactic antibiotic regimens in adults receiving intensive care and mechanical ventilation. The included studies compared topical plus systemic antibiotics versus placebo or no treatment; topical antibiotics versus no treatment; and topical plus systemic antibiotics versus systemic antibiotics.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included a total of 41 trials involving 11,004 participants (five new studies were added in this update). The minimum duration of mechanical ventilation ranged from 2 (19 studies) to 6 days (one study). Thirteen studies reported the mean length of ICU stay, ranging from 11 to 33 days. The percentage of immunocompromised patients ranged from 0% (10 studies) to 22% (1 study).\nThe reporting quality of the majority of included studies was very poor, so we judged more than 40% of the studies as at unclear risk of selection bias. We judged all studies to be at low risk of performance bias, though 47.6% were open-label, because hospitals usually have standardised infection control programmes, and possible subjective decisions on who should be tested for the presence or absence of RTIs are unlikely in an ICU setting. Regarding detection bias, we judged all included studies as at low risk for the outcome mortality. For the outcome RTIs, we judged all double-blind studies as at low risk of detection bias. We judged five open-label studies as at high risk of detection bias, as the diagnosis of RTI was not based on microbiological exams; we judged the remaining open-label studies as at low risk of detection bias, as a standardised set of diagnostic criteria, including results of microbiological exams, were used.\nTopical plus systemic antibiotic prophylaxis reduces overall mortality compared with placebo or no treatment (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.73 to 0.96; 18 studies; 5290 participants; high-certainty evidence). Based on an illustrative risk of 303 deaths in 1000 people this equates to 48 (95% CI 15 to 79) fewer deaths with topical plus systemic antibiotic prophylaxis. Topical plus systemic antibiotic prophylaxis probably reduces RTIs (RR 0.43, 95% CI 0.35 to 0.53; 17 studies; 2951 participants; moderate-certainty evidence). Based on an illustrative risk of 417 RTIs in 1000 people this equates to 238 (95% CI 196 to 271) fewer RTIs with topical plus systemic antibiotic prophylaxis.\nTopical antibiotic prophylaxis probably reduces overall mortality compared with no topical antibiotic prophylaxis (RR 0.96, 95% CI 0.87 to 1.05; 22 studies, 4213 participants; moderate-certainty evidence). Based on an illustrative risk of 290 deaths in 1000 people this equates to 19 (95% CI 37 fewer to 15 more) fewer deaths with topical antibiotic prophylaxis. Topical antibiotic prophylaxis may reduce RTIs (RR 0.57, 95% CI 0.44 to 0.74; 19 studies, 2698 participants; low-certainty evidence). Based on an illustrative risk of 318 RTIs in 1000 people this equates to 137 (95% CI 83 to 178) fewer RTIs with topical antibiotic prophylaxis.\nSixteen studies reported adverse events and dropouts due to adverse events, which were poorly reported with sparse data. The certainty of the evidence ranged from low to very low.\nAuthors' conclusions\nTreatments based on topical prophylaxis probably reduce respiratory infections, but not mortality, in adult patients receiving mechanical ventilation for at least 48 hours, whereas a combination of topical and systemic prophylactic antibiotics reduces both overall mortality and RTIs. However, we cannot rule out that the systemic component of the combined treatment provides a relevant contribution in the observed reduction of mortality. No conclusion can be drawn about adverse events as they were poorly reported with sparse data.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Twenty-two studies (52.4%) did not report the funding source; 6 studies (14.3%) were supported by public institutional grants; and 13 studies (30.1%) were totally or partially funded by pharmaceutical companies."
}
]
|
query-laysum | 4071 | [
{
"role": "user",
"content": "Abstract: Background\nIntermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection (UTI), urethral trauma and discomfort during catheter use. Despite the many designs of intermittent catheter, including different lengths, materials and coatings, it is unclear which catheter techniques, strategies or designs affect the incidence of UTI and other complications, measures of satisfaction/quality of life and cost-effectiveness.\nThis is an update of a Cochrane Review first published in 2007.\nObjectives\nTo assess the clinical and cost-effectiveness of different catheterisation techniques, strategies and catheter designs, and their impact, on UTI and other complications, and measures of satisfaction/quality of life among adults and children whose long-term bladder condition is managed by intermittent catheterisation.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 April 2021), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification.\nSelection criteria\nRandomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheterisation techniques, strategies or catheter designs.\nData collection and analysis\nAs per standard Cochrane methodological procedures, two review authors independently extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. Outcomes included the number of people with symptomatic urinary tract infections, complications such as urethral trauma/bleeding, comfort and ease of use of catheters, participant satisfaction and preference, quality of life measures and economic outcomes.\nMain results\nWe included 23 trials (1339 randomised participants), including twelve RCTs and eleven cross-over trials. Most were small (fewer than 60 participants completed), although three trials had more than 100 participants. Length of follow-up ranged from one month to 12 months and there was considerable variation in definitions of UTI. Most of the data from cross-over trials were not presented in a useable form for this review.\nRisk of bias was unclear in many domains due to insufficient information in the trial reports and several trials were judged to have a high risk of performance bias due to lack of blinding and a high risk of attrition bias. The certainty of evidence was downgraded for risk of bias, and imprecision due to low numbers of participants.\nAseptic versus clean technique\nWe are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI because the evidence is low-certainty and the 95% confidence interval (CI) is consistent with possible benefit and possible harm (RR 1.20 95% CI 0.54 to 2.66; one study; 36 participants). We identified no data relating to the risk of adverse events comparing aseptic and clean techniques or participant satisfaction or preference.\nSingle-use (sterile) catheter versus multiple-use (clean)\nWe are uncertain if there is any difference between single-use and multiple-use catheters in terms of the risk of symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.98, 95% CI 0.55, 1.74; two studies; 97 participants). One study comparing single-use catheters to multiple-use catheters reported zero adverse events in either group; no other adverse event data were reported for this comparison. We identified no data for participant satisfaction or preference.\nHydrophilic-coated catheters versus uncoated catheters\nWe are uncertain if there is any difference between hydrophilic and uncoated catheters in terms of the number of people with symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.89, 95% CI 0.69 to 1.14; two studies; 98 participants). Uncoated catheters probably slightly reduce the risk of urethral trauma and bleeding compared to hydrophilic-coated catheters (RR 1.37, 95% CI 1.01 to 1.87; moderate-certainty evidence). The evidence is uncertain if hydrophilic-coated catheters compared with uncoated catheters has any effect on participant satisfaction measured on a 0-10 scale (MD 0.7 higher, 95% CI 0.19 to 1.21; very low-certainty evidence; one study; 114 participants). Due to the paucity of data, we could not assess the certainty of evidence relating to participant preference (one cross-over trial of 29 participants reported greater preference for a hydrophilic-coated catheter (19/29) compared to an uncoated catheter (10/29)).\nAuthors' conclusions\nDespite a total of 23 trials, the paucity of useable data and uncertainty of the evidence means that it remains unclear whether the incidence of UTI or other complications is affected by use of aseptic or clean technique, single (sterile) or multiple-use (clean) catheters, coated or uncoated catheters or different catheter lengths. The current research evidence is uncertain and design and reporting issues are significant. More well-designed trials are needed. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheterisation techniques and strategies, and catheter designs.\n\nGiven the provided abstract, please respond to the following query: \"Aseptic versus clean techniques\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI. We identified no data relating to the risk of adverse events."
}
]
|
query-laysum | 4072 | [
{
"role": "user",
"content": "Abstract: Background\nCranberries contain proanthocyanidins (PACs), which inhibit the adherence of p-fimbriated Escherichia coli to the urothelial cells lining the bladder. Cranberry products have been used widely for several decades to prevent urinary tract infections (UTIs). This is the fifth update of a review first published in 1998 and updated in 2003, 2004, 2008, and 2012.\nObjectives\nTo assess the effectiveness of cranberry products in preventing UTIs in susceptible populations.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register up to 13 March 2023 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register Search Portal (ICTRP) and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) or quasi-RCTs of cranberry products compared with placebo, no specific treatment or other intervention (antibiotics, probiotics) for the prevention of UTIs were included.\nData collection and analysis\nTwo authors independently assessed and extracted data. Information was collected on methods, participants, interventions and outcomes (incidence of symptomatic UTIs, positive culture results, side effects, adherence to therapy). Risk ratios (RR) with 95% confidence intervals (CI) were calculated where appropriate. Study quality was assessed using the Cochrane risk of bias assessment tool. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFor this update 26 new studies were added, bringing the total number of included studies to 50 (8857 randomised participants). The risk of bias for sequence generation and allocation concealment was low for 29 and 28 studies, respectively. Thirty-six studies were at low risk of performance bias, and 23 studies were at low risk of detection bias. Twenty-seven, 41, and 17 studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nForty-five studies compared cranberry products with placebo or no specific treatment in six different groups of participants. Twenty-six of these 45 studies could be meta-analysed for the outcome of symptomatic, culture-verified UTIs. In moderate certainty evidence, cranberry products reduced the risk of UTIs (6211 participants: RR 0.70, 95% CI 0.58 to 0.84; I² = 69%). When studies were divided into groups according to the treatment indication, cranberry products probably reduced the risk of symptomatic, culture-verified UTIs in women with recurrent UTIs (8 studies, 1555 participants: RR 0.74, 95% CI 0.55 to 0.99; I² = 54%), in children (5 studies, 504 participants: RR 0.46, 95% CI 0.32 to 0.68; I² = 21%) and in people with a susceptibility to UTIs due to an intervention (6 studies, 1434 participants: RR 0.47, 95% CI 0.37 to 0.61; I² = 0%). However, in low certainty evidence, there may be little or no benefit in elderly institutionalised men and women (3 studies, 1489 participants: RR 0.93, 95% CI 0.67 to 1.30; I² = 9%), pregnant women (3 studies, 765 participants: RR 1.06, 95% CI 0.75 to 1.50; I² = 3%), or adults with neuromuscular bladder dysfunction with incomplete bladder emptying (3 studies, 464 participants: RR 0.97, 95% CI 0.78 to 1.19; I² = 0%).\nOther comparisons were cranberry products with probiotics (three studies) or antibiotics (six studies), cranberry tablets with cranberry liquid (one study), and different doses of PACs (two studies).\nCompared to antibiotics, cranberry products may make little or no difference to the risk of symptomatic, culture-verified UTIs (2 studies, 385 participants: RR 1.03, 95% CI 0.80 to 1.33; I² = 0%) or the risk of clinical symptoms without culture (2 studies, 336 participants: RR 1.30, 95% CI 0.79 to 2.14; I² = 68%). Compared to probiotics, cranberry products may reduce the risk of symptomatic, culture-verified UTIs (3 studies, 215 participants: RR 0.39, 95% CI 0.27 to 0.56; I = 0%). It is unclear whether efficacy differs between cranberry juice and tablets or between different doses of PACs as the certainty of the evidence was very low.\nThe number of participants with gastrointestinal side effects probably does not differ between those taking cranberry products and those receiving placebo or no specific treatment (10 studies, 2166 participants: RR 1.33, 95% CI 1.00 to 1.77; I² = 0%; moderate certainty evidence). There was no clear relationship between compliance with therapy and the risk for repeat UTIs. No difference in the risk for UTIs could be demonstrated between low, moderate and high doses of PACs.\nAuthors' conclusions\nThis update adds a further 26 studies taking the total number of studies to 50 with 8857 participants. These data support the use of cranberry products to reduce the risk of symptomatic, culture-verified UTIs in women with recurrent UTIs, in children, and in people susceptible to UTIs following interventions. The evidence currently available does not support its use in the elderly, patients with bladder emptying problems, or pregnant women.\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 RCTs involving 8857 people. Forty-five RCTs compared cranberry with a placebo or no treatment. Taking cranberries as a juice, tablets or capsules reduced the number of UTIs in women with recurrent UTIs, in children with UTIs and in people susceptible to UTIs following an intervention such as bladder radiotherapy. However, UTIs did not appear to be reduced in elderly institutionalised men and women, in adults with neuromuscular bladder dysfunction and incomplete bladder emptying, or in pregnant women. Few people reported any side effects with the most common being tummy pain. We did not find enough information to determine if cranberry products are more or less effective compared with antibiotics or probiotics in preventing further UTIs."
}
]
|
query-laysum | 4073 | [
{
"role": "user",
"content": "Abstract: Background\nBecause immunological aberrations might be the cause of miscarriage in some women, several immunotherapies have been used to treat women with otherwise unexplained recurrent pregnancy loss.\nObjectives\nThe objective of this review was to assess the effects of any immunotherapy, including paternal leukocyte immunization and intravenous immunoglobulin on the live birth rate in women with previous unexplained recurrent miscarriages.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (11 February 2014) and reference lists of retrieved studies.\nSelection criteria\nRandomized trials of immunotherapies used to treat women with three or more prior miscarriages and no more than one live birth after, in whom all recognized non-immunologic causes of recurrent miscarriage had been ruled out and no simultaneous treatment was given.\nData collection and analysis\nThe review author and the two co-authors independently extracted data and assessed study quality for all studies considered for this review.\nMain results\nTwenty trials of high quality were included. The various forms of immunotherapy did not show significant differences between treatment and control groups in terms of subsequent live births: paternal cell immunization (12 trials, 641 women), Peto odds ratio (Peto OR) 1.23, 95% confidence interval (CI) 0.89 to 1.70; third-party donor cell immunization (three trials, 156 women), Peto OR 1.39, 95% CI 0.68 to 2.82; trophoblast membrane infusion (one trial, 37 women), Peto OR 0.40, 95% CI 0.11 to 1.45; or intravenous immunoglobulin, (eight trials, 303 women), Peto OR 0.98, 95% CI 0.61 to 1.58.\nAuthors' conclusions\nPaternal cell immunization, third-party donor leukocytes, trophoblast membranes, and intravenous immunoglobulin provide no significant beneficial effect over placebo in improving the live birth rate.\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 sought to determine whether immunological treatments would improve the chance of live births in women with a history of recurrent miscarriage.Study characteristicsWe included 20 randomized controlled trials involving 1137 women, which took place from 1985 and 2004 in 11 countries. The trials examined four different forms of immunotherapy: immunization using white blood cells from the woman's partner (12 trials, 641 women), white blood cells from a third-party donor (three trials, 156 women), products derived from early embryos (one trial, 37 women), or antibodies derived from blood (intravenous immunoglobulin) (eight trials 303 women)."
}
]
|
query-laysum | 4074 | [
{
"role": "user",
"content": "Abstract: Background\nManipulation and mobilisation are commonly used to treat neck pain. This is an update of a Cochrane review first published in 2003, and previously updated in 2010.\nObjectives\nTo assess the effects of manipulation or mobilisation alone compared wiith those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up. When appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes.\nSearch methods\nReview authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies. We updated this search in June 2015, but these results have not yet been incorporated.\nSelection criteria\nRandomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain.\nData collection and analysis\nTwo review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs).\nMain results\nWe included 51 trials (2920 participants, 18 trials of manipulation/mobilisation versus control; 34 trials of manipulation/mobilisation versus another treatment, 1 trial had two comparisons).\nCervical manipulation versus inactive control:For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up.\nCervical manipulation versus another active treatment:For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up.\nThoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality).\nThoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain.\nMobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control.\nMobilisation versus another active treatment:For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality).\nAuthors' conclusions\nAlthough support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed.\nFindings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No high-quality evidence was found, so uncertainty about the effectiveness of mobilisation or manipulation for neck pain remains. Future research is likely to have an important impact on the effect estimate. Authors of this review encountered many challenges, for example, the number of participants in most trials was small, 80% (41/51) of the included studies were of low or very low quality and evidence on the optimum dosage requirement was limited."
}
]
|
query-laysum | 4075 | [
{
"role": "user",
"content": "Abstract: Background\nShoulder replacement surgery is an established treatment for patients with end-stage glenohumeral osteoarthritis or rotator cuff tear arthropathy who have not improved with non-operative treatment. Different types of shoulder replacement are commonly used, but their relative benefits and risks compared versus one another and versus other treatments are uncertain. This expanded scope review is an update of a Cochrane Review first published in 2010.\nObjectives\nTo determine the benefits and harms of shoulder replacement surgery in adults with osteoarthritis (OA) of the shoulder, including rotator cuff tear arthropathy (RCTA).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, SportDiscus, and Web of Science up to January 2019. We also searched clinical trial registers, conference proceedings, and reference lists from previous systematic reviews and included studies.\nSelection criteria\nWe included randomised studies comparing any type of shoulder replacement surgery versus any other surgical or non-surgical treatment, no treatment, or placebo. We also included randomised studies comparing any type of shoulder replacement or technique versus another. Study participants were adults with osteoarthritis of the glenohumeral joint or rotator cuff tear arthropathy.\nWe assessed the following major outcomes: pain, function, participant-rated global assessment of treatment success, quality of life, adverse events, serious adverse events, and risk of revision or re-operation or treatment failure.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We collected trial data on benefits and harms.\nMain results\nWe included 20 studies involving 1083 participants (1105 shoulders). We found five studies comparing one type of shoulder replacement surgery to another type of shoulder replacement surgery, including three studies comparing conventional stemmed total shoulder replacement (TSR) surgery to stemmed humeral hemiarthroplasty. The remaining 15 studies compared one type of shoulder replacement to the same type of replacement performed with a technical modification or a different prosthetic component. We found no studies comparing shoulder replacement surgery to any other type of surgical treatment or to any type of non-surgical treatment. We found no studies comparing reverse total shoulder replacement surgery to any other type of treatment or to any type of replacement.\n\nTrial size varied from 16 to 161 participants. Participant mean age ranged from 63 to 81 years. 47% of participants were male. Sixteen trials reported participants with a diagnosis of osteoarthritis and intact rotator cuff tendons. Four trials reported patients with osteoarthritis and a rotator cuff tear or rotator cuff tear arthropathy.\n\nAll studies were at unclear or high risk of bias for at least two domains, and only one study was free from high risk of bias (included in the main comparison). The most common sources of bias were lack of blinding of participants and assessors, attrition, and major baseline imbalance.\n\nThree studies allowed a comparison of conventional stemmed TSR surgery versus stemmed humeral hemiarthroplasty in people with osteoarthritis. At two years, low-quality evidence from two trials (downgraded for bias and imprecision) suggested there may be a small but clinically uncertain improvement in pain and function. On a scale of 0 to 10 (0 is no pain), mean pain was 2.78 points after stemmed humeral hemiarthroplasty and 1.49 points lower (0.1 lower to 2.88 lower) after conventional stemmed TSR. On a scale of 0 to 100 (100 = normal function), the mean function score was 72.8 points after stemmed humeral hemiarthroplasty and 10.57 points higher (2.11 higher to 19.02 higher) after conventional stemmed TSR. There may be no difference in quality of life based on low-quality evidence, downgraded for risk of bias and imprecision. On a scale of 0 to 100 (100 = normal), mean mental quality of life was rated as 57.4 points after stemmed humeral hemiarthroplasty and 1.0 point higher (5.1 lower to 7.1 higher) after conventional stemmed TSR.\nWe are uncertain whether there is any difference in the rate of adverse events or the rate of revision, re-operation, or treatment failure based on very low-quality evidence (downgraded three levels for risk of bias and serious imprecision). The rate of any adverse event following stemmed humeral hemiarthroplasty was 286 per 1000, and following conventional stemmed TSR 143 per 1000, for an absolute difference of 14% fewer events (25% fewer to 21% more). Adverse events included fractures, dislocations, infections, and rotator cuff failure. The rate of revision, re-operation, or treatment failure was 103 per 1000, and following conventional stemmed TSR 77 per 1000, for an absolute difference of 2.6% fewer events (8% fewer to 15% more).\nParticipant-rated global assessment of treatment success was not reported.\nAuthors' conclusions\nAlthough it is an established procedure, no high-quality randomised trials have been conducted to determine whether shoulder replacement might be more effective than other treatments for osteoarthritis or rotator cuff tear arthropathy of the shoulder. We remain uncertain about which type or technique of shoulder replacement surgery is most effective in different situations. When humeral hemiarthroplasty was compared to TSR surgery for osteoarthritis, low-quality evidence led to uncertainty about whether there is a clinically important benefit for patient-reported pain or function and suggested there may be little or no difference in quality of life. Evidence is insufficient to show whether TSR is associated with greater or less risk of harm than humeral hemiarthroplasty. Available randomised studies did not provide sufficient data to reliably inform conclusions about adverse events and harm. Although reverse TSR is now the most commonly performed type of shoulder replacement, we found no studies comparing reverse TSR to any other type of treatment.\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": "For the main comparison, the quality of evidence for assessing pain, function, and quality of life was low. For assessment of adverse events and further operations, the quality of evidence was very low. Across the other 12 comparisons, the quality of evidence was also very low."
}
]
|
query-laysum | 4076 | [
{
"role": "user",
"content": "Abstract: Background\nIntimate partner violence (IPV) damages individuals, their children, communities, and the wider economic and social fabric of society. Some governments and professional organisations recommend screening all women for IPV rather than asking only women with symptoms (case-finding). Here, we examine the evidence for whether screening benefits women and has no deleterious effects.\nObjectives\nTo assess the effectiveness of screening for IPV conducted within healthcare settings on identification, referral, re-exposure to violence, and health outcomes for women, and to determine if screening causes any harm.\nSearch methods\nOn 17 February 2015, we searched CENTRAL, Ovid MEDLINE, Embase, CINAHL, six other databases, and two trial registers. We also searched the reference lists of included articles and the websites of relevant organisations.\nSelection criteria\nRandomised or quasi-randomised controlled trials assessing the effectiveness of IPV screening where healthcare professionals either directly screened women face-to-face or were informed of the results of screening questionnaires, as compared with usual care (which could include screening that did not involve a healthcare professional).\nData collection and analysis\nTwo authors independently assessed the risk of bias in the trials and undertook data extraction. For binary outcomes, we calculated a standardised estimation of the odds ratio (OR). For continuous data, either a mean difference (MD) or standardised mean difference (SMD) was calculated. All are presented with a 95% confidence interval (CI).\nMain results\nWe included 13 trials that recruited 14,959 women from diverse healthcare settings (antenatal clinics, women's health clinics, emergency departments, primary care) predominantly located in high-income countries and urban settings. The majority of studies minimised selection bias; performance bias was the greatest threat to validity. The overall quality of the body of evidence was low to moderate, mainly due to heterogeneity, risk of bias, and imprecision.\nWe excluded five of 13 studies from the primary analysis as they either did not report identification data, or the way in which they did was not consistent with clinical identification by healthcare providers. In the remaining eight studies (n = 10,074), screening increased clinical identification of victims/survivors (OR 2.95, 95% CI 1.79 to 4.87, moderate quality evidence).\nSubgroup analyses suggested increases in identification in antenatal care (OR 4.53, 95% CI 1.82 to 11.27, two studies, n = 663, moderate quality evidence); maternal health services (OR 2.36, 95% CI 1.14 to 4.87, one study, n = 829, moderate quality evidence); and emergency departments (OR 2.72, 95% CI 1.03 to 7.19, three studies, n = 2608, moderate quality evidence); but not in hospital-based primary care (OR 1.53, 95% CI 0.79 to 2.94, one study, n = 293, moderate quality evidence).\nOnly two studies (n = 1298) measured referrals to domestic violence support services following clinical identification. We detected no evidence of an effect on referrals (OR 2.24, 95% CI 0.64 to 7.86, low quality evidence).\nFour of 13 studies (n = 2765) investigated prevalence (excluded from main analysis as rates were not clinically recorded); detection of IPV did not differ between face-to-face screening and computer/written-based assessment (OR 1.12, 95% CI 0.53 to 2.36, moderate quality evidence).\nOnly two studies measured women's experience of violence (three to 18 months after screening) and found no evidence that screening decreased IPV.\nOnly one study reported on women's health with no differences observable at 18 months.\nAlthough no study reported adverse effects from screening interventions, harm outcomes were only measured immediately afterwards and only one study reported outcomes at three months.\nThere was insufficient evidence on which to judge whether screening increases uptake of specialist services, and no studies included an economic evaluation.\nAuthors' conclusions\nThe evidence shows that screening increases the identification of women experiencing IPV in healthcare settings. Overall, however, rates were low relative to best estimates of prevalence of IPV in women seeking healthcare. Pregnant women in antenatal settings may be more likely to disclose IPV when screened, however, rigorous research is needed to confirm this. There was no evidence of an effect for other outcomes (referral, re-exposure to violence, health measures, harm arising from screening). Thus, while screening increases identification, there is insufficient evidence to justify screening in healthcare settings. Furthermore, there remains a need for studies comparing universal screening to case-finding (with or without advocacy or therapeutic interventions) for women's long-term wellbeing in order to inform IPV identification policies in healthcare settings.\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": "Eight studies with 10,074 women looked at whether healthcare professionals asked about abuse, discussed it, and/or documented abuse in participating women's records. There was a twofold increase in the number of women identified in this way compared to the comparison group. The quality of this evidence was moderate. We looked at smaller groups within the overall group, and found, for example, that pregnant women were four times as likely to be identified by a screening intervention as pregnant women in a comparison group. We did not see an increase in referral behaviours of healthcare professionals but only two studies measured referrals in the same way and there were some shortcomings to these studies. We could not tell if screening increased uptake of specialist services and no studies examined if it is cost-effective to screen. We also looked to see if different methods were better at picking up abuse, for example, you might expect that women would be more willing to disclose to a computer, but we did not find one method to be better than another. We found an absence overall of studies examining the recurrence of violence (only two studies looked at this, and saw no effect) and women's health (only one study looked at this, and found no difference 18 months later). Finally, many studies included some short-term assessment of adverse outcomes, but reported none.\nThere is a mismatch between the increased numbers of women picked up through screening by healthcare professionals and the high numbers of women attending healthcare settings actually affected by domestic violence. We would need more evidence to show screening actually increases referring and women's engagement with support services, and/or reduces violence and positively impacts on their health and wellbeing. On this basis, we concluded that there is insufficient evidence to recommend asking all women about abuse in healthcare settings. It may be more effective at this time to train healthcare professionals to ask women who show signs of abuse or those in high-risk groups, and provide them with a supportive response and information, and plan with them for their safety."
}
]
|
query-laysum | 4077 | [
{
"role": "user",
"content": "Abstract: Background\nDisease-modifying pharmacological agents for transthyretin (TTR)-related familial amyloid polyneuropathy (FAP) have become available in the last decade, but evidence on their efficacy and safety is limited. This review focuses on disease-modifying pharmacological treatment for TTR-related and other FAPs, encompassing amyloid kinetic stabilisers, amyloid matrix solvents, and amyloid precursor inhibitors.\nObjectives\nTo assess and compare the efficacy, acceptability, and tolerability of disease-modifying pharmacological agents for familial amyloid polyneuropathies (FAPs).\nSearch methods\nOn 18 November 2019, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase. We reviewed reference lists of articles and textbooks on peripheral neuropathies. We also contacted experts in the field. We searched clinical trials registries and manufacturers' websites.\nSelection criteria\nWe included randomised clinical trials (RCTs) or quasi-RCTs investigating any disease-modifying pharmacological agent in adults with FAPs.\nDisability due to FAP progression was the primary outcome. Secondary outcomes were severity of peripheral neuropathy, change in modified body mass index (mBMI), quality of life, severity of depression, mortality, and adverse events during the trial.\nData collection and analysis\nWe followed standard Cochrane methodology.\nMain results\nThe review included four RCTs involving 655 people with TTR-FAP. The manufacturers of the drugs under investigation funded three of the studies. The trials investigated different drugs versus placebo and we did not conduct a meta-analysis.\nOne RCT compared tafamidis with placebo in early-stage TTR-FAP (128 randomised participants). The trial did not explore our predetermined disability outcome measures. After 18 months, tafamidis might reduce progression of peripheral neuropathy slightly more than placebo (Neuropathy Impairment Score (NIS) in the lower limbs; mean difference (MD) -3.21 points, 95% confidential interval (CI) -5.63 to -0.79; P = 0.009; low-certainty evidence). However, tafamidis might lead to little or no difference in the change of quality of life between groups (Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score; MD -4.50 points, 95% CI -11.27 to 2.27; P = 0.19; very low-certainty evidence). No clear between-group difference was found in the numbers of participants who died (risk ratio (RR) 0.65, 95% CI 0.11 to 3.74; P = 0.63; very low-certainty evidence), who dropped out due to adverse events (RR 1.29, 95% CI 0.30 to 5.54; P = 0.73; very low-certainty evidence), or who experienced at least one severe adverse event during the trial (RR 1.16, 95% CI 0.37 to 3.62; P = 0.79; very low-certainty evidence).\nOne RCT compared diflunisal with placebo (130 randomised participants). At month 24, diflunisal might reduce progression of disability (Kumamoto Score; MD -4.90 points, 95% CI -7.89 to -1.91; P = 0.002; low-certainty evidence) and peripheral neuropathy (NIS plus 7 nerve tests; MD -18.10 points, 95% CI -26.03 to -10.17; P < 0.001; low-certainty evidence) more than placebo. After 24 months, changes from baseline in the quality of life measured by the 36-Item Short-Form Health Survey score showed no clear difference between groups for the physical component (MD 6.10 points, 95% CI 2.56 to 9.64; P = 0.001; very low-certainty evidence) and the mental component (MD 4.40 points, 95% CI -0.19 to 8.99; P = 0.063; very low-certainty evidence). There was no clear between-group difference in the number of people who died (RR 0.46, 95% CI 0.15 to 1.41; P = 0.17; very low-certainty evidence), in the number of dropouts due to adverse events (RR 2.06, 95% CI 0.39 to 10.87; P = 0.39; very low-certainty evidence), and in the number of people who experienced at least one severe adverse event (RR 0.77, 95% CI 0.18 to 3.32; P = 0.73; very low-certainty evidence) during the trial.\nOne RCT compared patisiran with placebo (225 randomised participants). After 18 months, patisiran reduced both progression of disability (Rasch-built Overall Disability Scale; least-squares MD 8.90 points, 95% CI 7.00 to 10.80; P < 0.001; moderate-certainty evidence) and peripheral neuropathy (modified NIS plus 7 nerve tests - Alnylam version; least-squares MD -33.99 points, 95% CI -39.86 to -28.13; P < 0.001; moderate-certainty evidence) more than placebo. At month 18, the change in quality of life between groups favoured patisiran (Norfolk QOL-DN total score; least-squares MD -21.10 points, 95% CI -27.20 to -15.00; P < 0.001; low-certainty evidence). There was little or no between-group difference in the number of participants who died (RR 0.61, 95% CI 0.21 to 1.74; P = 0.35; low-certainty evidence), dropped out due to adverse events (RR 0.33, 95% CI 0.13 to 0.82; P = 0.017; low-certainty evidence), or experienced at least one severe adverse event (RR 0.91, 95% CI 0.64 to 1.28; P = 0.58; low-certainty evidence) during the trial.\nOne RCT compared inotersen with placebo (172 randomised participants). The trial did not explore our predetermined disability outcome measures. From baseline to week 66, inotersen reduced progression of peripheral neuropathy more than placebo (modified NIS plus 7 nerve tests - Ionis version; MD -19.73 points, 95% CI -26.50 to -12.96; P < 0.001; moderate-certainty evidence). At week 65, the change in quality of life between groups favoured inotersen (Norfolk QOL-DN total score; MD -10.85 points, 95% CI -17.25 to -4.45; P < 0.001; low-certainty evidence). Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo. More dropouts due to adverse events were observed in the inotersen than in the placebo group (RR 8.57, 95% CI 1.16 to 63.07; P = 0.035; low-certainty evidence).\nThere were no studies addressing apolipoprotein AI-FAP, gelsolin-FAP, and beta-2-microglobulin-FAP.\nAuthors' conclusions\nEvidence on the pharmacological treatment of FAPs from RCTs is limited to TTR-FAP. No studies directly compare disease-modifying pharmacological treatments for TTR-FAP. Results from placebo-controlled trials indicate that tafamidis, diflunisal, patisiran, and inotersen may be beneficial in TTR-FAP, but further investigations are needed. Since direct comparative studies for TTR-FAP will be hampered by sample size and costs required to demonstrate superiority of one drug over another, long-term non-randomised open-label studies monitoring their efficacy and safety are needed.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors found four relevant studies, which involved 655 adults with TTR-FAP.\nIn one study, people with early-stage TTR-FAP received tafamidis or placebo for 18 months. Disability was not measured. The evidence suggested that tafamidis may reduce both the proportion of people with progression of peripheral neuropathy and the mean change (worsening) of nerve damage (based on a score of strength and sensation) compared to placebo. It is uncertain whether tafamidis has an effect on quality of life and the number of deaths, dropouts due to harmful effects or any severe side effects.\nEvidence from a 24-month study in people with TTR-FAP suggested that compared to placebo, diflunisal may slightly decrease disability due to FAP progression and lessen worsening of peripheral neuropathy. It is uncertain whether diflunisal has an effect on quality of life and number of deaths, dropouts due to side effects, and people who experience severe side effects.\nResults from an 18-month study in people with TTR-FAP suggested that compared to placebo, patisiran probably decreases disability due to FAP progression, and lessens worsening of peripheral neuropathy. Quality of life may decline slightly less with patisiran than placebo. Patisiran may lead to little or no difference in mortality, dropouts due to side effects or number of people experiencing severe side effects.\nIn the fourth study, people with TTR-FAP received inotersen or placebo for 66 weeks. Disability was not measured. This study indicated that inotersen probably reduces worsening of peripheral neuropathy, but may have little effect on the change in quality of life compared to placebo. Inotersen may be associated with numbers of adverse events above the placebo rate, illustrated by an increase in the number of dropouts due to side effects compared to placebo. There was little or no difference in mortality or number of people experiencing severe side effects.\nThe review authors did not find any study addressing drug therapy for people with other types of FAP.\nThree of the four studies were funded by the manufacturer of the drug investigated."
}
]
|
query-laysum | 4078 | [
{
"role": "user",
"content": "Abstract: Background\nThe Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant’s nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks.\nObjectives\nTo determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device.\nSearch methods\nSearches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR.\nData collection and analysis\nEach review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials.\nThe evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence).\nResuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence).\nWe identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another.\nAuthors' conclusions\nNasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR.\nResuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.\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 giving breathing support to babies through their nose (using a nasal prong, a tube that fits into one or both nostrils, or a nasal mask, a mask placed over the nose) would result in less death, intubations, and complications after birth, compared with a face mask or a laryngeal mask airway; or if one type of nasal interface was better than another for the same results."
}
]
|
query-laysum | 4079 | [
{
"role": "user",
"content": "Abstract: Background\nExcessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling.\nThis is an update of a Cochrane Review published in 2007.\nObjectives\nTo assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption.\nMain results\nWe included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention.\nWe found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).\nWe found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-20 g/week, 95% CI -40 to 1; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).\nExtended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).\nOnly five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms.\nSources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment.\nAuthors' conclusions\nWe found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to September 2017."
}
]
|
query-laysum | 4080 | [
{
"role": "user",
"content": "Abstract: Background\nInfants born preterm (before 37 weeks' gestation) are at risk of respiratory distress syndrome (RDS) and need for respiratory support due to lung immaturity. One course of prenatal corticosteroids, administered to women at risk of preterm birth, reduces the risk of respiratory morbidity and improves survival of their infants, but these benefits do not extend beyond seven days. Repeat doses of prenatal corticosteroids have been used for women at ongoing risk of preterm birth more than seven days after their first course of corticosteroids, with improvements in respiratory outcomes, but uncertainty remains about any long-term benefits and harms. This is an update of a review last published in 2015.\nObjectives\nTo assess the effectiveness and safety, using the best available evidence, of a repeat dose(s) of prenatal corticosteroids, given to women who remain at risk of preterm birth seven or more days after an initial course of prenatal corticosteroids with the primary aim of reducing fetal and neonatal mortality and morbidity.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials, including cluster-randomised trials, of women who had already received one course of corticosteroids seven or more days previously and were still at risk of preterm birth, randomised to further dose(s) or no repeat doses, with or without placebo. Quasi-randomised trials were excluded. Abstracts were accepted if they met specific criteria. All trials had to meet criteria for trustworthiness, including a search of the Retraction Watch database for retractions or expressions of concern about the trials or their publications.\nData collection and analysis\nWe used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed trial quality and scientific integrity. We chose primary outcomes based on clinical importance as measures of effectiveness and safety, including serious outcomes, for the women and their fetuses/infants, infants in early childhood (age two to less than five years), the infant in mid- to late childhood (age five to less than 18 years) and the infant as an adult. We assessed risk of bias at the outcome level using the RoB 2 tool and assessed certainty of evidence using GRADE.\nMain results\nWe included 11 trials (4895 women and 5975 babies). High-certainty evidence from these trials indicated that treatment of women who remain at risk of preterm birth seven or more days after an initial course of prenatal corticosteroids with repeat dose(s) of corticosteroids, compared with no repeat corticosteroid treatment, reduced the risk of their infants experiencing the primary infant outcome of RDS (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.74 to 0.90; 3540 babies; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 11 to 29) and had little or no effect on chronic lung disease (RR 1.00, 95% CI 0.83 to 1.22; 5661 babies). Moderate-certainty evidence indicated that the composite of serious infant outcomes was probably reduced with repeat dose(s) of corticosteroids (RR 0.88, 95% CI 0.80 to 0.97; 9 trials, 5736 babies; NNTB 39, 95% CI 24 to 158), as was severe lung disease (RR 0.83, 95% CI 0.72 to 0.97; NNTB 45, 95% CI 27 to 256; 4955 babies). Moderate-certainty evidence could not exclude benefit or harm for fetal or neonatal or infant death less than one year of age (RR 0.95, 95% CI 0.73 to 1.24; 5849 babies), severe intraventricular haemorrhage (RR 1.13, 95% CI 0.69 to 1.86; 5066 babies) and necrotising enterocolitis (RR 0.84, 95% CI 0.59 to 1.22; 5736 babies).\nIn women, moderate-certainty evidence found little or no effect on the likelihood of a caesarean birth (RR 1.03, 95% CI 0.98 to 1.09; 4266 mothers). Benefit or harm could not be excluded for maternal death (RR 0.32, 95% 0.01 to 7.81; 437 women) and maternal sepsis (RR 1.13, 95% CI 0.93 to 1.39; 4666 mothers). The evidence was unclear for risk of adverse effects and discontinuation of therapy due to maternal adverse effects. No trials reported breastfeeding status at hospital discharge or risk of admission to the intensive care unit.\nAt early childhood follow-up, moderate- to high-certainty evidence identified little or no effect of exposure to repeat prenatal corticosteroids compared with no repeat corticosteroids for primary outcomes relating to neurodevelopment (neurodevelopmental impairment: RR 0.97, 95% CI 0.85 to 1.10; 3616 children), survival without neurodevelopmental impairment (RR 1.01, 95% CI 0.98 to 1.04; 3845 children) and survival without major neurodevelopmental impairment (RR 1.02, 95% CI 0.98 to 1.05; 1816 children). An increase or decrease in the risk of death since randomisation could not be excluded (RR 1.06, 95% CI 0.81 to 1.40; 5 trials, 4565 babies randomised).\nAt mid-childhood follow-up, moderate-certainty evidence identified little or no effect of exposure to repeat prenatal corticosteroids compared with no repeat corticosteroids on survival free of neurocognitive impairment (RR 1.01, 95% CI 0.95 to 1.08; 963 children) or survival free of major neurocognitive impairment (RR 1.00, 95% CI 0.97 to 1.04; 2682 children). Benefit or harm could not be excluded for death since randomisation (RR 0.93, 95% CI 0.69 to 1.26; 2874 babies randomised) and any neurocognitive impairment (RR 0.96, 95% CI 0.72 to 1.29; 897 children).\nNo trials reported data for follow-up into adolescence or adulthood.\nRisk of bias across outcomes was generally low although there were some concerns of bias. For childhood follow-up, most outcomes had some concerns of risk of bias due to missing data from loss to follow-up.\nAuthors' conclusions\nThe short-term benefits for babies included less respiratory distress and fewer serious health problems in the first few weeks after birth with repeat dose(s) of prenatal corticosteroids for women still at risk of preterm birth seven days or more after an initial course. The current available evidence reassuringly shows no significant harm for the women or child in early and mid-childhood, although no benefit.\nFurther research is needed on the long-term benefits and risks for the baby into adulthood.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Infants born preterm (before 37 weeks' of pregnancy) are at risk of difficulty breathing and lung disease because their lungs are not fully developed. One course of prenatal (administered during pregnancy) corticosteroids, given to women who may give birth early, helps develop the baby's lungs and improves survival. This benefit does not last beyond seven days so those babies born preterm more than seven days after the course of corticosteroid are still at risk of difficulty breathing and lung disease. This review details the evidence available for the benefits and harms of giving a further course(s) of corticosteroids with the aim of extending the benefits on lung development and breathing."
}
]
|
query-laysum | 4081 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in Issue 2, 2018.\nDiagnoses of endometrial cancer are increasing secondary to the rising prevalence of obesity. Obesity plays an important role in promoting the development of endometrial cancer, by inducing a state of unopposed oestrogen excess, insulin resistance and inflammation. It also affects treatment, increasing the risk of surgical complications and the complexity of radiotherapy planning, and may additionally impact on subsequent survival. Weight-loss interventions have been associated with improvements in breast and colorectal cancer-specific survival, as well as a reduction in the risk of cardiovascular disease, which is a frequent cause of death in endometrial cancer survivors.\nObjectives\nTo evaluate the benefits and harm of weight-loss interventions, in addition to standard management, on overall survival and the frequency of adverse events in women with endometrial cancer who are overweight or obese compared with any other intervention, usual care, or placebo.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was from January 2018 to June 2022 (original review searched from inception to January 2018).\nSelection criteria\nWe included randomised controlled trials (RCTs) of interventions to facilitate weight loss in women with endometrial cancer who are overweight or obese undergoing treatment for, or previously treated for, endometrial cancer compared with any other intervention, usual care, or placebo.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. overall survival and 2. frequency of adverse events. Our secondary outcomes were 3. recurrence-free survival, 4. cancer-specific survival, 5. weight loss, 6. cardiovascular and metabolic event frequency and 7. quality of Life. We used GRADE to assess certainty of evidence. We contacted study authors to obtain missing data, including details of any adverse events.\nMain results\nWe identified nine new RCTs and combined these with the three RCTs identified in the original review. Seven studies are ongoing.\nThe 12 RCTs randomised 610 women with endometrial cancer who were overweight or obese. All studies compared combined behavioural and lifestyle interventions designed to facilitate weight loss through dietary modification and increased physical activity with usual care. Included RCTs were of low or very low quality, due to high risk of bias by failing to blind participants, personnel and outcome assessors, and significant loss to follow-up (withdrawal rate up to 28% and missing data up to 65%, largely due to the effects of the COVID-19 pandemic). Importantly, the short duration of follow-up limits the directness of the evidence in evaluating the impact of these interventions on any of the survival and other longer-term outcomes.\nCombined behaviour and lifestyle interventions were not associated with improved overall survival compared with usual care at 24 months (risk ratio (RR) mortality, 0.23, 95% confidence interval (CI) 0.01 to 4.55, P = 0.34; 1 RCT, 37 participants; very low-certainty evidence). There was no evidence that such interventions were associated with improvements in cancer-specific survival or cardiovascular event frequency as the studies reported no cancer-related deaths, myocardial infarctions or strokes, and there was only one episode of congestive heart failure at six months (RR 3.47, 95% CI 0.15 to 82.21; P = 0.44, 5 RCTs, 211 participants; low-certainty evidence). Only one RCT reported recurrence-free survival; however, there were no events. Combined behaviour and lifestyle interventions were not associated with significant weight loss at either six or 12 months compared with usual care (at six months: mean difference (MD) −1.39 kg, 95% CI −4.04 to 1.26; P = 0.30, I2 = 32%; 5 RCTs, 209 participants; low-certainty evidence). Combined behaviour and lifestyle interventions were not associated with increased quality of life, when measured using 12-item Short Form (SF-12) Physical Health questionnaire, SF-12 Mental Health questionnaire, Cancer-Related Body Image Scale, Patient Health Questionnaire 9-Item Version or Functional Assessment of Cancer Therapy – General (FACT-G) at 12 months when compared with usual care (FACT-G: MD 2.77, 95% CI −0.65 to 6.20; P = 0.11, I2 = 0%; 2 RCTs, 89 participants; very low-certainty evidence). The trials reported no serious adverse events related to weight loss interventions, for example hospitalisation or deaths. It is uncertain whether lifestyle and behavioural interventions were associated with a higher or lower risk of musculoskeletal symptoms (RR 19.03, 95% CI 1.17 to 310.52; P = 0.04; 8 RCTs, 315 participants; very low-certainty evidence; note: 7 studies reported musculoskeletal symptoms but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 1 study rather than 8).\nAuthors' conclusions\nThe inclusion of new relevant studies has not changed the conclusions of this review.\nThere is currently insufficient high-quality evidence to determine the effect of combined lifestyle and behavioural interventions on survival, quality of life or significant weight loss in women with a history of endometrial cancer who are overweight or obese compared to those receiving usual care. The limited evidence suggests that there is little or no serious or life-threatening adverse effects due to these interventions, and it is uncertain if musculoskeletal problems were increased, as only one out of eight studies reporting this outcome had any events. Our conclusion is based on low- and very low-certainty evidence from a small number of trials and few women. Therefore, we have very little confidence in the evidence: the true effect of weight-loss interventions in women with endometrial cancer and obesity is currently unknown.\nFurther methodologically rigorous, adequately powered RCTs are required with follow-up of five to 10 years of duration. These should focus on the effects of varying dietary modification regimens, and pharmacological treatments associated with weight loss and bariatric surgery on survival, quality of life, weight loss and adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases for well-designed clinical trials (called randomised controlled trials) of interventions (treatments) to facilitate weight loss in women with endometrial cancer who were overweight or obese undergoing treatment for, or previously treated for, endometrial cancer compared with any other intervention, usual care, or placebo (dummy treatment)."
}
]
|
query-laysum | 4082 | [
{
"role": "user",
"content": "Abstract: Background\nThe use of mechanical thrombectomy to restore intracranial blood flow after proximal large artery occlusion by a thrombus has increased over time and led to better outcomes than intravenous thrombolytic therapy alone. Currently, the type of anaesthetic technique during mechanical thrombectomy is under debate as having a relevant impact on neurological outcomes.\nObjectives\nTo assess the effects of different types of anaesthesia for endovascular interventions in people with acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Specialised Register of Trials on 5 July 2022, and CENTRAL, MEDLINE, and seven other databases on 21 March 2022. We performed searches of reference lists of included trials, grey literature sources, and other systematic reviews.\nSelection criteria\nWe included all randomised controlled trials with a parallel design that compared general anaesthesia versus local anaesthesia, conscious sedation anaesthesia, or monitored care anaesthesia for mechanical thrombectomy in acute ischaemic stroke. We also included studies reported as full-text, those published as abstract only, and unpublished data. We excluded quasi-randomised trials, studies without a comparator group, and studies with a retrospective design.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. The outcomes were assessed at different time periods, ranging from the onset of the stroke symptoms to 90 days after the start of the intervention. The main outcomes were functional outcome, neurological impairment, stroke-related mortality, all intracranial haemorrhage, target artery revascularisation status, time to revascularisation, adverse events, and quality of life. All included studies reported data for early (up to 30 days) and long-term (above 30 days) time points.\nMain results\nWe included seven trials with 982 participants, which investigated the type of anaesthesia for endovascular treatment in large vessel occlusion in the intracranial circulation. The outcomes were assessed at different time periods, ranging from the onset of stroke symptoms to 90 days after the procedure. Therefore, all included studies reported data for early (up to 30 days) and long-term (above 30 up to 90 days) time points.\nGeneral anaesthesia versus non-general anaesthesia(early)\nWe are uncertain about the effect of general anaesthesia on functional outcomes compared to non-general anaesthesia (mean difference (MD) 0, 95% confidence interval (CI) –0.31 to 0.31; P = 1.0; 1 study, 90 participants; very low-certainty evidence) and in time to revascularisation from groin puncture until the arterial reperfusion (MD 2.91 minutes, 95% CI –5.11 to 10.92; P = 0.48; I² = 48%; 5 studies, 498 participants; very low-certainty evidence). General anaesthesia may lead to no difference in neurological impairment up to 48 hours after the procedure (MD –0.29, 95% CI –1.18 to 0.59; P = 0.52; I² = 0%; 7 studies, 982 participants; low-certainty evidence), and in stroke-related mortality (risk ratio (RR) 0.98, 95% CI 0.52 to 1.84; P = 0.94; I² = 0%; 3 studies, 330 participants; low-certainty evidence), all intracranial haemorrhages (RR 0.92, 95% CI 0.65 to 1.29; P = 0.63; I² = 0%; 5 studies, 693 participants; low-certainty evidence) compared to non-general anaesthesia. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia (RR 0.21, 95% CI 0.05 to 0.79; P = 0.02; I² = 71%; 2 studies, 229 participants; low-certainty evidence). General anaesthesia improves target artery revascularisation compared to non-general anaesthesia (RR 1.10, 95% CI 1.02 to 1.18; P = 0.02; I² = 29%; 7 studies, 982 participants; moderate-certainty evidence). There were no available data for quality of life.\nGeneral anaesthesia versus non-general anaesthesia (long-term)\nThere is no difference in general anaesthesia compared to non-general anaesthesia for dichotomous and continuous functional outcomes (dichotomous: RR 1.21, 95% CI 0.93 to 1.58; P = 0.16; I² = 29%; 4 studies, 625 participants; low-certainty evidence; continuous: MD –0.14, 95% CI –0.34 to 0.06; P = 0.17; I² = 0%; 7 studies, 978 participants; low-certainty evidence). General anaesthesia showed no changes in stroke-related mortality compared to non-general anaesthesia (RR 0.88, 95% CI 0.64 to 1.22; P = 0.44; I² = 12%; 6 studies, 843 participants; low-certainty evidence). There were no available data for neurological impairment, all intracranial haemorrhages, target artery revascularisation status, time to revascularisation from groin puncture until the arterial reperfusion, adverse events (haemodynamic instability), or quality of life.\nOngoing studies\nWe identified eight ongoing studies. Five studies compared general anaesthesia versus conscious sedation anaesthesia, one study compared general anaesthesia versus conscious sedation anaesthesia plus local anaesthesia, and two studies compared general anaesthesia versus local anaesthesia. Of these studies, seven plan to report data on functional outcomes using the modified Rankin Scale, five studies on neurological impairment, six studies on stroke-related mortality, two studies on all intracranial haemorrhage, five studies on target artery revascularisation status, four studies on time to revascularisation, and four studies on adverse events. One ongoing study plans to report data on quality of life. One study did not plan to report any outcome of interest for this review.\nAuthors' conclusions\nIn early outcomes, general anaesthesia improves target artery revascularisation compared to non-general anaesthesia with moderate-certainty evidence. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia with low-certainty evidence. We found no evidence of a difference in neurological impairment, stroke-related mortality, all intracranial haemorrhage and haemodynamic instability adverse events between groups with low-certainty evidence. We are uncertain whether general anaesthesia improves functional outcomes and time to revascularisation because the certainty of the evidence is very low.\nHowever, regarding long-term outcomes, general anaesthesia makes no difference to functional outcomes compared to non-general anaesthesia with low-certainty evidence. General anaesthesia did not change stroke-related mortality when compared to non-general anaesthesia with low-certainty evidence. There were no reported data for other outcomes.\nIn view of the limited evidence of effect, more randomised controlled trials with a large number of participants and good protocol design with a low risk of bias should be performed to reduce our uncertainty and to aid decision-making in the choice of anaesthesia.\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 know what type of anaesthesia approach promotes better patient outcomes during recanalisation therapies for acute ischaemic stroke."
}
]
|
query-laysum | 4083 | [
{
"role": "user",
"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: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The limited evidence available does not suggest that any one oral antibiotic is better than another for treating bacterial folliculitis and boils.\nThe comparative benefits and risks of other treatments such as antiseptics or light therapy are unclear, because too few studies have investigated this."
}
]
|
query-laysum | 4084 | [
{
"role": "user",
"content": "Abstract: Background\nStroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment (carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of a Cochrane Review, originally published in 1999, and most recently updated in 2017.\nObjectives\nTo determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke).\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science Core Collection, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) portal to October 2019. We also reviewed the reference lists of all relevant studies and abstract books from research proceedings.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing carotid artery surgery plus best medical treatment with best medical treatment alone.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted the data. We assessed the results and the quality of the evidence of the primary and secondary outcomes by the GRADE method, which classifies the quality of evidence as high, moderate, low, or very low.\nMain results\nWe included three trials involving 6343 participants. The trials differed in the methods of measuring carotid stenosis and in the definition of stroke. Using the primary electronic data files, we pooled and analysed individual patient data on 6092 participants (35,000 patient-years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials, and redefining outcome events where necessary, to achieve comparability.\nSurgery increased the five-year risk of any stroke or operative death in participants with less than 30% stenosis (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.99 to 1.56; 2 studies, 1746 participants; high-quality evidence). Surgery decreased the five-year risk of any stroke or operative death in participants with 30% to 49% stenosis (RR 0.97, 95% CI 0.79 to 1.19; 2 studies, 1429 participants; high-quality evidence), was of benefit in participants with 50% to 69% stenosis (RR 0.77, 95% CI 0.63 to 0.94; 3 studies, 1549 participants; moderate-quality evidence), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (RR 0.53, 95% CI 0.42 to 0.67; 3 studies, 1095 participants; moderate-quality evidence). However, surgery decreased the five-year risk of any stroke or operative death in participants with near-occlusions (RR 0.95, 95% CI 0.59 to 1.53; 2 studies, 271 participants; moderate-quality evidence).\nAuthors' conclusions\nCarotid endarterectomy reduced the risk of recurrent stroke for people with significant stenosis. Endarterectomy might be of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence) and highly beneficial for those with 70% to 99% stenosis (moderate-quality evidence).\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of moderate or high quality for all the results. Therefore, we can be moderately or very confident in the results."
}
]
|
query-laysum | 4085 | [
{
"role": "user",
"content": "Abstract: Background\nVenous leg ulcers (VLUs) are a common type of complex wound that have a negative impact on people's lives and incur high costs for health services and society. It has been suggested that prolonged high levels of protease activity in the later stages of the healing of chronic wounds may be associated with delayed healing. Protease modulating treatments have been developed which seek to modulate protease activity and thereby promote healing in chronic wounds.\nObjectives\nTo determine whether protease activity is an independent prognostic factor for the healing of venous leg ulcers.\nSearch methods\nIn February 2018, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and CINAHL.\nSelection criteria\nWe included prospective and retrospective longitudinal studies with any follow-up period that recruited people with VLUs and investigated whether protease activity in wound fluid was associated with future healing of VLUs. We included randomised controlled trials (RCTs) analysed as cohort studies, provided interventions were taken into account in the analysis, and case-control studies if there were no available cohort studies. We also included prediction model studies provided they reported separately associations of individual prognostic factors (protease activity) with healing. Studies of any type of protease or combination of proteases were eligible, including proteases from bacteria, and the prognostic factor could be examined as a continuous or categorical variable; any cut-off point was permitted. The primary outcomes were time to healing (survival analysis) and the proportion of people with ulcers completely healed; the secondary outcome was change in ulcer size/rate of wound closure. We extracted unadjusted (simple) and adjusted (multivariable) associations between the prognostic factor and healing.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion at each stage, and undertook data extraction, assessment of risk of bias and GRADE assessment. We collected association statistics where available. No study reported adjusted analyses: instead we collected unadjusted results or calculated association measures from raw data. We calculated risk ratios when both outcome and prognostic factor were dichotomous variables. When the prognostic factor was reported as continuous data and healing outcomes were dichotomous, we either performed regression analysis or analysed the impact of healing on protease levels, analysing as the standardised mean difference. When both prognostic factor and outcome were continuous data, we reported correlation coefficients or calculated them from individual participant data.\nWe displayed all results on forest plots to give an overall visual representation. We planned to conduct meta-analyses where this was appropriate, otherwise we summarised narratively.\nMain results\nWe included 19 studies comprising 21 cohorts involving 646 participants. Only 11 studies (13 cohorts, 522 participants) had data available for analysis. Of these, five were prospective cohort studies, four were RCTs and two had a type of case-control design. Follow-up time ranged from four to 36 weeks. Studies covered 10 different matrix metalloproteases (MMPs) and two serine proteases (human neutrophil elastase and urokinase-type plasminogen activators). Two studies recorded complete healing as an outcome; other studies recorded partial healing measures. There was clinical and methodological heterogeneity across studies; for example, in the definition of healing, the type of protease and its measurement, the distribution of active and bound protease species, the types of treatment and the reporting of results. Therefore, meta-analysis was not performed. No study had conducted multivariable analyses and all included evidence was of very low certainty because of the lack of adjustment for confounders, the high risk of bias for all studies except one, imprecision around the measures of association and inconsistency in the direction of association. Collectively the research indicated complete uncertainty as to the association between protease activity and VLU healing.\nAuthors' conclusions\nThis review identified very low validity evidence regarding any association between protease activity and VLU healing and there is complete uncertainty regarding the relationship. The review offers information for both future research and systematic review methodology.\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": "Venous leg ulcers can last weeks, months or years. Leg ulcers can be painful, may become infected, and may affect mobility and quality of life. The usual treatment for venous leg ulcers is compression therapy (e.g. compression (elastic) bandages), but even this does not work for everyone (about a third of people still have wounds that have not healed after six months). We wanted to find out why these wounds often do not heal, and whether there are factors in the wound (called biomarkers) that can indicate which wounds are unlikely to heal. It has been suggested that wounds are slow to heal when there are high levels of protease. In this review, we investigated whether there was any evidence that higher protease levels at the start of a study were associated with slower healing leg ulcers or less healing at a future time point (such as six months).\nIn February 2018, we searched for relevant studies that had a reliable design and that investigated links between protease levels and future healing of venous leg ulcers. We found 19 studies involving 646 people. Not all studies reported the age and sex of participants. In those that did, the average age of the participants varied from 51 to 75 years. Eleven studies gave results we could use, involving 13 groups of people. Most people had wounds that had been there for at least three months."
}
]
|
query-laysum | 4086 | [
{
"role": "user",
"content": "Abstract: Background\nTrigger finger is a common hand condition that occurs when movement of a finger flexor tendon through the first annular (A1) pulley is impaired by degeneration, inflammation, and swelling. This causes pain and restricted movement of the affected finger. Non-surgical treatment options include activity modification, oral and topical non-steroidal anti-inflammatory drugs (NSAIDs), splinting, and local injections with anti-inflammatory drugs.\nObjectives\nTo review the benefits and harms of non-steroidal anti-inflammatory drugs (NSAIDs) versus placebo, glucocorticoids, or different NSAIDs administered by the same route for trigger finger.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, CNKI (China National Knowledge Infrastructure), ProQuest Dissertations and Theses, www.ClinicalTrials.gov, and the WHO trials portal until 30 September 2020. We applied no language or publication status restrictions.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) and quasi-randomised trials of adult participants with trigger finger that compared NSAIDs administered topically, orally, or by injection versus placebo, glucocorticoid, or different NSAIDs administered by the same route.\nData collection and analysis\nTwo or more review authors independently screened the reports, extracted data, and assessed risk of bias and GRADE certainty of evidence. The seven major outcomes were resolution of trigger finger symptoms, persistent moderate or severe symptoms, recurrence of symptoms, total active range of finger motion, residual pain, patient satisfaction, and adverse events. Treatment effects were reported as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs).\nMain results\nTwo RCTs conducted in an outpatient hospital setting were included (231 adult participants, mean age 58.6 years, 60% female, 95% to 100% moderate to severe disease). Both studies compared a single injection of a non-selective NSAID (12.5 mg diclofenac or 15.0 mg ketorolac) given at lower than normal doses with a single injection of a glucocorticoid (triamcinolone 20 mg or 5 mg), with maximum follow-up duration of 12 weeks or 24 weeks.\nIn both studies, we detected risk of attrition and performance bias. One study also had risk of selection bias. The effects of treatment were sensitive to assumptions about missing outcomes. All seven outcomes were reported in one study, and five in the other.\nNSAID injection may offer little to no benefit over glucocorticoid injection, based on low- to very low-certainty evidence from two trials. Evidence was downgraded for bias and imprecision. There may be little to no difference between groups in resolution of symptoms at 12 to 24 weeks (34% with NSAIDs, 41% with glucocorticoids; absolute effect 7% lower, 95% confidence interval (CI) 16% lower to 5% higher; 2 studies, 231 participants; RR 0.83, 95% CI 0.62 to 1.11; low-certainty evidence). The rate of persistent moderate to severe symptoms may be higher at 12 to 24 weeks in the NSAIDs group (28%) compared to the glucocorticoid group (14%) (absolute effect 14% higher, 95% CI 2% to 33% higher; 2 studies, 231 participants; RR 2.03, 95% CI 1.19 to 3.46; low-certainty evidence). We are uncertain whether NSAIDs result in fewer recurrences at 12 to 24 weeks (1%) compared to glucocorticoid (21%) (absolute effect 20% lower, 95% CI 21% to 13% lower; 2 studies, 231 participants; RR 0.07, 95% CI 0.01 to 0.38; very low-certainty evidence). There may be little to no difference between groups in mean total active motion at 24 weeks (235 degrees with NSAIDs, 240 degrees with glucocorticoid) (absolute effect 5% lower, 95% CI 34.54% lower to 24.54% higher; 1 study, 99 participants; MD -5.00, 95% CI -34.54 to 24.54; low-certainty evidence). There may be little to no difference between groups in residual pain at 12 to 24 weeks (20% with NSAIDs, 24% with glucocorticoid) (absolute effect 4% lower, 95% CI 11% lower to 7% higher; 2 studies, 231 participants; RR 0.84, 95% CI 0.54 to 1.31; low-certainty evidence). There may be little to no difference between groups in participant-reported treatment success at 24 weeks (64% with NSAIDs, 68% with glucocorticoid) (absolute effect 4% lower, 95% CI 18% lower to 15% higher; 1 study, 121 participants; RR 0.95, 95% CI 0.74 to 1.23; low-certainty evidence).\nWe are uncertain whether NSAID injection has an effect on adverse events at 12 to 24 weeks (1% with NSAIDs, 1% with glucocorticoid) (absolute effect 0% difference, 95% CI 2% lower to 3% higher; 2 studies, 231 participants; RR 2.00, 95% CI 0.19 to 21.42; very low-certainty evidence).\nAuthors' conclusions\nFor adults with trigger finger, by 24 weeks' follow-up, results from two trials show that compared to glucocorticoid injection, NSAID injection offered little to no benefit in the treatment of trigger finger. Specifically, there was no difference in resolution, symptoms, recurrence, total active motion, residual pain, participant-reported treatment success, or adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Treating trigger finger\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For some people, trigger finger might get better without treatment. If it doesn't, treatments include:\n1. rest - avoiding certain activities;\n2. physical therapy;\n3. strapping the finger to a piece of plastic (splint) to reduce movement;\n4. medicines known as NSAIDs taken by mouth or directly through the skin to reduce pain; and\n5. steroid medicines injected to reduce swelling.\nIf none of these treatments works, surgery may be needed to help the tendon move freely again."
}
]
|
query-laysum | 4087 | [
{
"role": "user",
"content": "Abstract: Background\n18F-florbetapir uptake by brain tissue measured by positron emission tomography (PET) is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using amyloid biomarkers tests like 18F-florbetapir. These tests, added to the MCI core clinical criteria, might increase the diagnostic test accuracy (DTA) of a testing strategy. However, the DTA of 18F-florbetapir to predict the progression from MCI to Alzheimer’s disease dementia (ADD) or other dementias has not yet been systematically evaluated.\nObjectives\nTo determine the DTA of the 18F-florbetapir PET scan for detecting people with MCI at time of performing the test who will clinically progress to ADD, other forms of dementia (non-ADD), or any form of dementia at follow-up.\nSearch methods\nThis review is current to May 2017. We searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), BIOSIS Citation Index (Thomson Reuters Web of Science), Web of Science Core Collection, including the Science Citation Index (Thomson Reuters Web of Science) and the Conference Proceedings Citation Index (Thomson Reuters Web of Science), LILACS (BIREME), CINAHL (EBSCOhost), ClinicalTrials.gov (https://clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (http://www.who.int/ictrp/search/en/). We also searched ALOIS, the Cochrane Dementia & Cognitive Improvement Group’s specialised register of dementia studies (http://www.medicine.ox.ac.uk/alois/). We checked the reference lists of any relevant studies and systematic reviews, and performed citation tracking using the Science Citation Index to identify any additional relevant studies. No language or date restrictions were applied to the electronic searches.\nSelection criteria\nWe included studies that had prospectively defined cohorts with any accepted definition of MCI at time of performing the test and the use of 18F-florbetapir scan to evaluate the DTA of the progression from MCI to ADD or other forms of dementia. In addition, we only selected studies that applied a reference standard for Alzheimer’s dementia diagnosis, for example, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) or Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria.\nData collection and analysis\nWe screened all titles and abstracts identified in electronic-database searches. Two review authors independently selected studies for inclusion and extracted data to create two-by-two tables, showing the binary test results cross-classified with the binary reference standard. We used these data to calculate sensitivities, specificities, and their 95% confidence intervals. Two independent assessors performed quality assessment using the QUADAS-2 tool plus some additional items to assess the methodological quality of the included studies.\nMain results\nWe included three studies, two of which evaluated the progression from MCI to ADD, and one evaluated the progression from MCI to any form of dementia.\nProgression from MCI to ADD was evaluated in 448 participants. The studies reported data on 401 participants with 1.6 years of follow-up and in 47 participants with three years of follow-up. Sixty-one (15.2%) participants converted at 1.6 years follow-up; nine (19.1%) participants converted at three years of follow-up.\nProgression from MCI to any form of dementia was evaluated in five participants with 1.5 years of follow-up, with three (60%) participants converting to any form of dementia.\nThere were concerns regarding applicability in the reference standard in all three studies. Regarding the domain of flow and timing, two studies were considered at high risk of bias.\nMCI to ADD;\nProgression from MCI to ADD in those with a follow-up between two to less than four years had a sensitivity of 67% (95% CI 30 to 93) and a specificity of 71% (95% CI 54 to 85) by visual assessment (n = 47, 1 study).\nProgression from MCI to ADD in those with a follow-up between one to less than two years had a sensitivity of 89% (95% CI 78 to 95) and a specificity of 58% (95% CI 53 to 64) by visual assessment, and a sensitivity of 87% (95% CI 76 to 94) and a specificity of 51% (95% CI 45 to 56) by quantitative assessment by the standardised uptake value ratio (SUVR)(n = 401, 1 study).\nMCI to any form of dementia;\nProgression from MCI to any form of dementia in those with a follow-up between one to less than two years had a sensitivity of 67% (95% CI 9 to 99) and a specificity of 50% (95% CI 1 to 99) by visual assessment (n = 5, 1 study).\nMCI to any other forms of dementia (non-ADD);\nThere was no information regarding the progression from MCI to any other form of dementia (non-ADD).\nAuthors' conclusions\nAlthough sensitivity was good in one included study, considering the poor specificity and the limited data available in the literature, we cannot recommend routine use of 18F-florbetapir PET in clinical practice to predict the progression from MCI to ADD.\nBecause of the poor sensitivity and specificity, limited number of included participants, and the limited data available in the literature, we cannot recommend its routine use in clinical practice to predict the progression from MCI to any form of dementia.\nBecause of the high financial costs of 18F-florbetapir, clearly demonstrating the DTA and standardising the process of this modality are important prior to its wider use.\n\nGiven the provided abstract, please respond to the following query: \"Aim\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to evaluate the accuracy of the 18F-florbetapir PET scan in identifying those people with MCI who clinically progress to ADD, other types of dementia, or any form of dementia over a period of time."
}
]
|
query-laysum | 4088 | [
{
"role": "user",
"content": "Abstract: Background\nAppendicitis remains a difficult disease to diagnose, and imaging adjuncts are commonly employed. Magnetic resonance imaging (MRI) is an imaging test that can be used to diagnose appendicitis. It is not commonly regarded as a first-line imaging test for appendicitis, but the reported diagnostic accuracy in some studies is equivalent to computed tomography (CT) scans. As it does not expose patients to radiation, it is an attractive imaging modality, particularly in women and children.\nObjectives\nThe primary objective was to determine the diagnostic accuracy of MRI for detecting appendicitis in all patients.\nSecondary objectives:\nTo investigate the accuracy of MRI in subgroups of pregnant women, children, and adults.\nTo investigate the potential influence of MRI scanning variables such as sequences, slice thickness, or field of view.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase until February 2021. We searched the references of included studies and other systematic reviews to identify further studies. We did not exclude studies that were unpublished, published in another language, or retrospective.\nSelection criteria\nWe included studies that compared the outcome of an MRI scan for suspected appendicitis with a reference standard of histology, intraoperative findings, or clinical follow-up. Three study team members independently filtered search results for eligible studies.\nData collection and analysis\nWe independently extracted study data and assessed study quality using the Quality Assessment of Studies of Diagnostic Accuracy - Revised (QUADAS-2) tool. We used the bivariate model to calculate pooled estimates of sensitivity and specificity.\nMain results\nWe identified 58 studies with sufficient data for meta-analysis including a total of 7462 participants (1980 with and 5482 without acute appendicitis). Estimates of sensitivity ranged from 0.18 to 1.0; estimates of specificity ranged from 0.4 to 1.0. Summary sensitivity was 0.95 (95% confidence interval (CI) 0.94 to 0.97); summary specificity was 0.96 (95% CI 0.95 to 0.97). Sensitivity and specificity remained high on subgroup analysis for pregnant women (sensitivity 0.96 (95% CI 0.88 to 0.99); specificity 0.97 (95% CI 0.95 to 0.98); 21 studies, 2282 women); children (sensitivity 0.96 (95% CI 0.95 to 0.97); specificity 0.96 (95% CI 0.92 to 0.98); 17 studies, 2794 children); and adults (sensitivity 0.96 (95% CI 0.93 to 0.97); specificity 0.93 (95% CI 0.80 to 0.98); 9 studies, 1088 participants), as well as different scanning techniques. In a hypothetical cohort of 1000 patients, there would be 12 false-positive results and 30 false-negative results. Methodological quality of the included studies was poor, and the risk of bias was high or unclear in 53% to 83% of the QUADAS-2 domains.\nAuthors' conclusions\nMRI appears to be highly accurate in confirming and excluding acute appendicitis in adults, children, and pregnant women regardless of protocol. The methodological quality of the included studies was generally low due to incomplete and low standards of follow-up, so summary estimates of sensitivity and specificity may be biased. We could not assess the impact and direction of potential bias given the very low number of high-quality studies. Studies comparing MRI protocols were few, and although we found no influence of MRI protocol variables on the summary estimates of accuracy, our results do not rule out that some MRI protocols are more accurate than others.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We analysed the results of 58 studies with 7462 participants to calculate the accuracy of MRI. The results of these studies indicate that in theory, if MRI were to be used in 1000 patients with suspected appendicitis, where 250 patients actually had appendicitis, then:\n• an estimated 250 patients will have an MRI result indicating appendicitis, 12 of whom will not actually have appendicitis; and\n• of the 750 patients with a result indicating that appendicitis is not present, 30 will actually have appendicitis.\nMRI remained very accurate when looking specifically at adults, pregnant women, and children."
}
]
|
query-laysum | 4089 | [
{
"role": "user",
"content": "Abstract: Background\nGastrointestinal bleeding refers to loss of blood from any site of the digestive tract. In paediatric clinical practice, it is usually a complaint of children attending the emergency department as a symptom of diseases such as ulcers, gastric or oesophageal varices, gastritis, Mallory-Weiss tears, anorectal fissures, allergic colitis, infectious colitis, intussusception, Henoch-Schonlein purpura, and Meckel's diverticulum; it also occurs with high incidence in critically ill children hospitalised in intensive care units and is caused by stress-induced gastropathy. No matter what the cause of gastrointestinal bleeding, fasting is believed to be necessary due to the fear that eating may affect haemostasis or aggravate bleeding.\nObjectives\nTo assess the effects and safety of fasting for haemostasis in gastrointestinal bleeding in children.\nSearch methods\nWe searched EBM Reviews - the Cochrane Central Register of Controlled Trials (CENTRAL) (May 2016), Ovid MEDLINE(R) (1946 to 3 May 2016), EMBASE (1980 to 2016 Week 18), Chinese Biomedical Database (CBM) (1978 to 3 May 2016), China National Knowledge Infrastructure (CNKI) (1979 to 3 May 2016), VIP Database (1989 to 4 May 2016) and Wanfang Data (1990 to 4 May 2016). We used no restrictions on language or study setting and limited searches in CNKI and Wanfang Data to the medical field.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs in children with gastrointestinal bleeding that compared fasting with feeding.\nData collection and analysis\nTwo review authors independently screened the literature search results, and there were no disagreements.\nMain results\nWe identified no RCTs or quasi-RCTs that compared the effects and safety of fasting with feeding for haemostasis in children with gastrointestinal bleeding. No study fulfilled the criteria for considering studies for our review.\nAuthors' conclusions\nThere is currently no information available from RCTs or quasi-RCTs to support or refute the use of fasting for haemostasis in children with gastrointestinal bleeding.\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": "Gastrointestinal bleeding refers to loss of blood from any site of the digestive tract. If the bleeding site is near the ligament of Treitz (the muscle extending from the junction of the duodenum and jejunum to the diaphragm), it is described as upper gastrointestinal bleeding. If the bleeding site is away from the ligament of Treitz, it is described as lower gastrointestinal bleeding. People with a small amount of blood loss may have no symptoms, and have bloody vomiting or see blood in the stool with increased bleeding. Chronic mild gastrointestinal bleeding can lead to anaemia, causing fatigue or pallor; acute massive gastrointestinal bleeding can be life-threatening.\nGastrointestinal bleeding has two scenarios in children. The first is a complaint of attending the emergency department as a symptom of diseases such as ulcers, gastritis, Mallory-Weiss tears, anorectal fissures, allergic colitis, infectious colitis, intussusception, Henoch-Schonlein purpura, and Meckel's diverticulum. The second occurs in critically ill children hospitalised in intensive care units and is caused by stress-induced gastropathy. The incidence of the first scenario has not been well established, but there are substantial cases in paediatric intensive care units in the second scenario. Whatever the cause of gastrointestinal bleeding, fasting is believed to be necessary due to the fear that eating may affect haemostasis or aggravate bleeding."
}
]
|
query-laysum | 4090 | [
{
"role": "user",
"content": "Abstract: Background\nA pressure ulcer is defined as \"an area of localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure, or pressure in combination with shear\". The use of phototherapy - that is, light (or laser) used as an adjuvant, non-surgical intervention, with the aim of having a therapeutic effect on healing - has increased recently.\nObjectives\nTo determine the effects of phototherapy on the healing of pressure ulcers.\nSearch methods\nIn January 2014, we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid EMBASE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); and EBSCO CINAHL. We did not restrict the search by language or publication date.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effects of phototherapy (in addition to standard treatment) with sham phototherapy (in addition to standard treatment), another type of phototherapy (in addition to standard treatment) or standard or conventional treatment alone.\nData collection and analysis\nTwo review authors assessed studies for relevance and design according to the selection criteria, extracted data and evaluated study quality. The authors made attempts to obtain missing data by contacting study authors. Disagreement was resolved by consensus and discussion with a third review author.\nMain results\nWe identified seven RCTs involving 403 participants. All the trials were at unclear risk of bias. Trials compared the use of phototherapy with standard care only (six trials) or sham phototherapy (one trial). Only one of the trials included a third arm in which another type of phototherapy was applied. Overall, there was insufficient evidence to determine the relative effects of phototherapy for healing pressure ulcers. Time to complete healing was reported in three studies. Two studies showed the ultraviolet (UV) treated group had a shorter mean time to complete healing than the control group (mean difference -2.13 weeks (95% CI -3.53 to -0.72, P value 0.003)). One study reported that the laser group had a longer mean time to complete healing than the control group (mean difference 5.77 weeks; 95% CI -0.25 to 11.79). However, this result should be interpreted with caution, as these were small studies and the findings may have been due to chance. Three studies reported proportions of ulcers healed with a variety of results. One study reported a different outcome measure, and the other two studies had different treatment durations. These variations did not allow us to pool the studies and draw any conclusions as to whether phototherapy is effective or not. Adverse effects were reported in only two studies that compared phototherapy with control; the risk ratio for adverse events was imprecise. One study reported risk ratio (RR) 0.72 (95%CI 0.18 to 2.80). However, another study reported RR 0.89 (95% CI: 0.71 to 1.12) based on the number of events in each group, rather than the number of people with events. Among five studies reporting the rate of change in ulcer area, three studies found no statistically significant difference between the two groups. Pooling was not undertaken because of differences in outcome measures reported. The results were based on data from trials with unclear risk of bias for which generation of the randomisation sequence, concealment allocation and blinding of outcome assessors were unclear. No studies reported on quality of life, length of hospital stay, pain or cost.\nAuthors' conclusions\nWe are very uncertain as to the effects of phototherapy in treating pressure ulcers. The quality of evidence is very low due to the unclear risk of bias and small number of trials available for analysis. The possibility of benefit or harm of this treatment cannot be ruled out. Further research is recommended.\n\nGiven the provided abstract, please respond to the following query: \"Findings of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched the medical literature up to 7 January 2014, and identified seven relevant medical trials, with a total of 403 participants. Six trials compared the use of phototherapy with standard care only; one trial compared it with standard care plus sham phototherapy. Only one trial included a third treatment group that investigated another type of phototherapy.\nTwo trials reported the time taken for pressure ulcers to heal completely, and these showed an improvement in healing time for people in the phototherapy group who received treatment with ultraviolet light. However, this result should be interpreted with caution, as these were small, poor quality trials, at unclear risk of bias (i.e. with potentially misleading results), and the findings may have been due to chance. The other trials reported either conflicting results or various measures/time points among trials, which meant that we could not conclude whether or not phototherapy is effective for treating pressure ulcers. Two trials reported incidence of harmful (adverse) effects and noted no significant differences between the phototherapy and standard treatment groups. Four trials provided funding information, two from industry funding, the others from an institutional grant. No studies reported on quality of life, length of hospital stay, pain or cost.\nThis review identified only a few, small studies provided with insufficient evidence to support the use of phototherapy as a routine treatment for pressure ulcers. More trials will need to be conducted before it can be established whether this treatment works and is safe."
}
]
|
query-laysum | 4091 | [
{
"role": "user",
"content": "Abstract: Background\nIodine deficiency disorders (IDD) affect close to 1.9 billion people worldwide, and are a major public health concern in many countries. Among children, iodine deficiency is the main cause of potentially preventable deficits of central nervous system development and impairment of cognitive function, as well as goitre and hypothyroidism in people of all ages. Salt iodisation is the preferred strategy for IDD prevention and control, however, in some instances where salt is not the major condiment, alternate vehicles for iodine fortification have been considered.\nObjectives\nTo assess the effects of fortifying foods, beverages, condiments, or seasonings other than salt with iodine alone or in conjunction with other micronutrients, on iodine status and health-related outcomes in all populations.\nSearch methods\nStudies were identified through systematic searches of the following databases from their start date to January 2018: Cochrane Public Health Group Specialised Register; CENTRAL; MEDLINE; MEDLINE in Process; Embase; Web of Science; CINAHL; POPLINE; AGRICOLA; BIOSIS; Food Science and Technology Abstracts; OpenGrey; Bibliomap and TRoPHI; AGRIS; IBECS; Scielo; Global Index Medicus-AFRO and EMRO; LILACS; PAHO; WHOLIS; WPRO; IMSEAR; IndMED; and Native Health Research Database. We also searched reference list of relevant articles, conference proceedings, and databases of ongoing trials, and contacted experts and relevant organisations to identify any unpublished work. We applied no language or date restrictions.\nSelection criteria\nStudies were eligible if they were randomised or quasi-randomised controlled trials (RCT) with randomisation at either the individual or cluster level (including cross-over trials), non-randomised RCTs, or prospective observational studies with a control group, such as cohort studies, controlled before-and-after studies, and interrupted time series. We included studies that examined the effects of fortification of food, beverage, condiment, or seasoning with iodine alone, or in combination with other micronutrients versus the same unfortified food, or no intervention. We considered the following measures: death (all-cause), goitre, physical development, mental development, cognitive function and motor skill development, cretinism, hypothyroidism, adverse effects (any reported by trialists), urinary iodine concentration, thyroid-stimulating hormone (TSH) concentration, and serum thyroglobulin concentration. We included all populations, including pregnant women, from any country.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed risk of bias of included studies.\nWe used random-effects meta-analyses to combine data and generate an overall estimate of treatment effect, when more than one study examined the same outcome measure. The overall effect estimate was calculated as the mean difference (MD) or standardised mean difference (SMD) between the intervention group and the comparison group for continuous outcomes, and as odds ratio (OR) for dichotomous outcomes. We assessed the level of heterogeneity through the I² statistic. We conducted post-hoc subgroup analyses to explore possible sources of heterogeneity, and sensitivity analyses to check the robustness of the findings from the primary analyses. We assessed the quality of the evidence for each outcome using the GRADE framework.\nWhere it was not possible to pool the results in a meta-analysis, we provided a narrative summary of the outcomes.\nMain results\nEleven studies met the criteria, providing 14 comparisons, and capturing data on 4317 participants. Seven studies were RCTs, three were cluster non-RCTs, and one was a randomised cross-over design. Seven studies were carried out among school children (N = 3636), three among women of reproductive age (N = 648), and one among infants (N = 33). The studies used diverse types of food as vehicle for iodine delivery: biscuits, milk, fish sauce, drinking water, yoghourt, fruit beverage, seasoning powder, and infant formula milk. Daily amounts of iodine provided ranged from 35 µg/day to 220 µg/day; trial duration ranged from 11 days to 48 weeks. Five studies examined the effect of iodine fortification alone, two against the same unfortified food, and three against no intervention. Six studies evaluated the effect of cofortification of iodine with other micronutrients versus the same food without iodine but with different levels of other micronutrients. We assessed one study to be at low risk of bias for all bias domains, three at low risk of bias for all domains apart from selective reporting, and seven at an overall rating of high risk of bias.\nNo study assessed the primary outcomes of death, mental development, cognitive function, cretinism, or hypothyroidism, or secondary outcomes of TSH or serum thyroglobulin concentration. Two studies reported the effects on goitre, one on physical development measures, and one on adverse effects. All studies assessed urinary iodine concentration.\nThe effects of iodine fortification compared to control on goitre prevalence (OR 1.60, 95% CI 0.60 to 4.31; 1 non-RCT, 83 participants; very low-quality evidence), and five physical development measures were uncertain (1 non-RCT, 83 participants; very low-quality evidence): weight (MD 0.23 kg, 95% CI -6.30 to 6.77); height (MD -0.66 cm, 95% CI -4.64 to 3.33); weight-for-age (MD 0.05, 95% CI -0.59 to 0.69); height-for-age (MD -0.30, 95% CI -0.75 to 0.15); and weight-for-height (MD -0.21, 95% CI -0.51 to 0.10). One study reported that there were no adverse events observed during the cross-over trial (low-quality evidence).\nPooled results from RCTs showed that urinary iodine concentration significantly increased following iodine fortification (SMD 0.59, 95% CI 0.37 to 0.81; 6 RCTs, 2032 participants; moderate-quality evidence). This is equivalent to an increase of 38.32 µg/L (95% CI 24.03 to 52.61 µg/L). This effect was not observed in the meta-analysis of non-RCTs (SMD 0.25, 95% CI -0.16 to 0.66; 3 non-RCTs, 262 participants; very low-quality evidence). Sensitivity analyses did not change the effect observed in the primary analyses.\nAuthors' conclusions\nThe evidence on the effect of iodine fortification of foods, beverages, condiments, or seasonings other than salt on reducing goitre, improving physical development measures, and any adverse effects is uncertain. However, our findings suggest that the intervention likely increases urinary iodine concentration. Additional, adequately powered, high-quality studies on the effects of iodine fortification of foods on these, and other important outcomes, as well as its efficacy and safety, are required.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for articles from different sources including published research papers, unpublished reports, and through direct communication with experts and organisations working to address iodine and micronutrient deficiency. We last searched the databases in January 2018.\nEleven studies, which captured data on 4317 participants (3636 children, 648 women of reproductive age, and 33 infants), met our inclusion criteria. The type of foods used as vehicle to deliver iodine differed between the studies, and included biscuits, milk, fish sauce, drinking water, yoghourt, fruit beverage, seasoning powder, and infant formula milk. The amount of iodine provided to participants ranged from 35 µg/day to 220 µg/day, and study duration ranged from 11 days to 48 weeks. Of the 11 studies included, five examined the effect of adding iodine alone to foods compared to either no intervention or the same foods without iodine; while six evaluated the effect of adding iodine plus other micronutrients to foods compared to the same foods without iodine, but with different levels of other micronutrients."
}
]
|
query-laysum | 4092 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is one of the most common childhood infectious diseases. Pain is the key symptom of AOM and central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management. This is an update of a review first published in 2016.\nObjectives\nOur primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs as compared with paracetamol in children with AOM.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 5, April 2023; MEDLINE (Ovid, from 1946 to May 2023), Embase (from 1947 to May 2023), CINAHL (from 1981 to May 2023), LILACS (from 1982 to May 2023), and Web of Science Core Collection (from 1955 to May 2023). We searched the WHO ICTRP and ClinicalTrials.gov for completed and ongoing trials (23 May 2023).\nSelection criteria\nWe included randomised controlled trials comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in non-hospitalised children aged six months to 16 years with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors. We extracted and summarised data for the following comparisons: paracetamol versus placebo, NSAIDs versus placebo, NSAIDs versus paracetamol, and NSAIDs plus paracetamol versus paracetamol alone.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We rated the overall certainty of evidence for each outcome of interest using the GRADE approach.\nMain results\nWe included four trials (411 children) which were assessed at low to high risk of bias.\nParacetamol versus placebo\nData from one trial (148 children) informed this comparison. Paracetamol may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 10% versus 25%, risk ratio (RR) 0.38, 95% confidence interval (CI) 0.17 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) 7; low-certainty evidence). The evidence is very uncertain about the effects of paracetamol on fever at 48 hours (RR 1.03, 95% CI 0.07 to 16.12; very low-certainty evidence) and adverse events (RR 1.03, 95% CI 0.21 to 4.93; very low-certainty evidence). No data were available for our other outcomes of interest.\nNSAIDs versus placebo\nData from one trial (146 children) informed this comparison. Ibuprofen may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 7% versus 25%, RR 0.28, 95% CI 0.11 to 0.70; NNTB 6; low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen on fever at 48 hours (RR 1.06, 95% CI 0.07 to 16.57; very low-certainty evidence) and adverse events (RR 1.76, 95% CI 0.44 to 7.10; very low-certainty evidence). No data were available for our other outcomes of interest.\nNSAIDs versus paracetamol\nData from four trials (411 children) informed this comparison. The evidence is very uncertain about the effect of ibuprofen versus paracetamol in relieving ear pain at 24 hours (RR 0.83, 95% CI 0.59 to 1.18; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 0.91, 95% CI 0.54 to 1.54; 3 RCTs, 183 children; low-certainty evidence); and four to seven days (RR 0.74, 95% CI 0.17 to 3.23; 2 RCTs, 38 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol on mean pain score at 24 hours (0.29 lower, 95% CI 0.79 lower to 0.20 higher; 3 RCTs, 111 children; very low-certainty evidence); 48 to 72 hours (0.25 lower, 95% CI 0.66 lower to 0.16 higher; 3 RCTs, 108 children; very low-certainty evidence); and four to seven days (0.30 higher, 95% CI 1.78 lower to 2.38 higher; 2 RCTs, 31 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol in resolving fever at 24 hours (RR 0.69, 95% CI 0.24 to 2.00; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 1.18, 95% CI 0.31 to 4.44; 3 RCTs, 182 children; low-certainty evidence); and four to seven days (RR 2.75, 95% CI 0.12 to 60.70; 2 RCTs, 39 children; very low-certainty evidence).\nThe evidence is very uncertain about the effect of ibuprofen versus paracetamol on adverse events (RR 1.71, 95% CI 0.43 to 6.90; 3 RCTs, 281 children; very low-certainty evidence); reconsultations (RR 1.13, 95% CI 0.92 to 1.40; 1 RCT, 53 children; very low-certainty evidence); and delayed antibiotic prescriptions (RR 1.32, 95% CI 0.74 to 2.35; 1 RCT, 53 children; very low-certainty evidence).\nNo data were available on time to resolution of pain.\nNSAIDs plus paracetamol versus paracetamol alone\nData on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone came from two trials that provided crude subgroup data for 71 children with AOM. The small sample provided imprecise effect estimates, therefore we were unable to draw any firm conclusions (very low-certainty evidence).\nAuthors' conclusions\nDespite explicit guideline recommendations on the use of analgesics in children with AOM, the current evidence on the effectiveness of paracetamol or NSAIDs, alone or combined, in children with AOM is limited. Paracetamol and ibuprofen as monotherapies may be more effective than placebo in relieving short-term ear pain in children with AOM. The evidence is very uncertain for the effect of ibuprofen versus paracetamol on relieving short-term ear pain in children with AOM, as well as for the effectiveness of ibuprofen plus paracetamol versus paracetamol alone, thereby preventing any firm conclusions. Further research is needed to provide insights into the role of ibuprofen as adjunct to paracetamol, and other analgesics such as anaesthetic eardrops, for children with AOM.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that looked at the effectiveness of paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen), alone or combined, compared with placebo (dummy treatment) or no treatment in relieving pain in non-hospitalised children aged six months to 16 years with AOM. We also wanted to evaluate the effectiveness of NSAIDs as compared with paracetamol in these children. We compared and summarised the results of these studies, and rated our confidence in the evidence based on factors such as study methods and effect sizes."
}
]
|
query-laysum | 4093 | [
{
"role": "user",
"content": "Abstract: Background\nThe novel coronavirus disease (COVID-19) has led to significant mortality and morbidity, including a high incidence of related thrombotic events. There has been concern regarding hormonal contraception use during the COVID-19 pandemic, as this is an independent risk factor for thrombosis, particularly with estrogen-containing formulations. However, higher estrogen levels may be protective against severe COVID-19 disease. Evidence for risks of hormonal contraception use during the COVID-19 pandemic is sparse. We conducted a living systematic review that will be updated as new data emerge on the risk of thromboembolism with hormonal contraception use in patients with COVID-19.\nObjectives\nTo determine if use of hormonal contraception increases risk of venous and arterial thromboembolism in women with COVID-19.\nTo determine if use of hormonal contraception increases other markers of COVID-19 severity including hospitalization in the intensive care unit, acute respiratory distress syndrome, intubation, and mortality.\nA secondary objective is to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Global Index Medicus, Global Health, and Scopus from inception on March 2023, and monitored the literature monthly. We updated the search strategies with new terms and added the database Global Index Medicus in lieu of LILACS.\nSelection criteria\nWe included all published and ongoing studies of patients with COVID-19 comparing outcomes of those on hormonal contraception versus those not on hormonal contraception. This included case series and non-randomized studies of interventions (NRSI).\nData collection and analysis\nOne review author extracted study data and this was checked by a second author. Two authors individually assessed risk of bias for the comparative studies using the ROBINS-I tool and a third helped reconcile differences. For the living systematic review, we will publish updates to our synthesis every six months. In the event that we identify a study with a more rigorous study design than the current included evidence prior to the planned six-month update, we will expedite the synthesis publication.\nMain results\nWe included three comparative NRSIs with 314,704 participants total and two case series describing 13 patients. The three NRSIs had serious to critical risk of bias in several domains and low study quality. Only one NRSI ascertained current use of contraceptives based on patient report; the other two used diagnostic codes within medical records to assess hormonal contraception use, but did not confirm current use nor indication for use. None of the NRSIs included thromboembolism as an outcome. Studies were not similar enough in terms of their outcomes, interventions, and study populations to combine with meta-analyses. We therefore narratively synthesized all included studies.\nBased on results from one NRSI, there may be little to no effect of combined hormonal contraception use on odds of mortality for COVID-19 positive patients (OR 1.00, 95% CI 0.41 to 2.40; 1 study, 18,892 participants; very low-certainty evidence).\nTwo NRSIs examined hospitalization rates for hormonal contraception users versus non-users. Based on results from one NRSI, the odds of hospitalization for COVID-19 positive combined hormonal contraception users may be slightly decreased compared with non-users for patients with BMI under 35 kg/m2 (OR 0.79, 95% CI 0.64 to 0.97; 1 study, 295,689 participants; very low-certainty evidence). According to results of the other NRSI assessing use of any type of hormonal contraception, there may be little to no effect on hospitalization rates for COVID-19 positive individuals (OR 0.99, 95% CI 0.68 to 1.44; 1 study, 123 participants; very low-certainty evidence).\nWe included two case series because no comparative studies directly assessed thromboembolism as an outcome. In a case series of six pediatric COVID-19 positive patients with pulmonary embolism, one (older than 15 years of age) was using combined hormonal contraception. In a second case series of seven COVID-19 positive patients with cerebral venous thrombosis, one was using oral contraceptives.\nOne comparative study and one case series reported on intubation rates, but the evidence for both is very uncertain. In the comparative study of 123 COVID-19 positive patients (N = 44 using hormonal contraception and N = 79 not using hormonal contraception), no patients in either group required intubation. In the case series of seven individuals with cerebral venous thromboembolism, one oral contraceptive user and one non-user required intubation.\nAuthors' conclusions\nThere are no comparative studies assessing risk of thromboembolism in COVID-19 patients who use hormonal contraception, which was the primary objective of this review. Very little evidence exists examining the risk of increased COVID-19 disease severity for combined hormonal contraception users compared to non-users of hormonal contraception, and the evidence that does exist is of very low certainty.\nThe odds of hospitalization for COVID-19 positive users of combined hormonal contraceptives may be slightly decreased compared with those of hormonal contraceptive non-users, but the evidence is very uncertain as this is based on one study restricted to patients with BMI under 35 kg/m2. There may be little to no effect of combined hormonal contraception use on odds of intubation or mortality among COVID-19 positive patients, and little to no effect of using any type of hormonal contraception on odds of hospitalization and intubation for COVID-19 patients. We noted no large effect for risk of increased COVID-19 disease severity among hormonal contraception users.\nWe specifically noted gaps in pertinent data collection regarding hormonal contraception use such as formulation, hormone doses, and duration or timing of contraceptive use. Differing estrogens may have different thrombogenic potential given differing potency, so it would be important to know if a formulation contained, for example, ethinyl estradiol versus estradiol valerate. Additionally, we downgraded several studies for risk of bias because information on the timing of contraceptive use relative to COVID-19 infection and method adherence were not ascertained. No studies reported indication for hormonal contraceptive use, which is important as individuals who use hormonal management for medical conditions like heavy menstrual bleeding might have different risk profiles compared to individuals using hormones for contraception. Future studies should focus on including pertinent confounders like age, obesity, history of prior venous thromboembolism, risk factors for venous thromboembolism, and recent pregnancy.\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": "Hormonal birth control, especially birth control with estrogen, can increase chances of developing blood clots in the leg or lung or increase the chance of having a stroke. We have also seen that blood clots in the leg or lung can be a result of developing COVID-19. We are not sure if people who are taking hormonal birth control have a higher chance of developing blood clots if they contract COVID-19. We want to study this further so people who use hormonal contraception will know if they should stop or switch their birth control methods if they become COVID-19 positive."
}
]
|
query-laysum | 4094 | [
{
"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: \"Dropping out of the studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Two more participants out of 100 in the aquatic training groups dropped out of the studies (15 aquatic exercisers dropped out while 13 non-exercisers dropped out)."
}
]
|
query-laysum | 4095 | [
{
"role": "user",
"content": "Abstract: Background\nSomatoform disorders are characterised by chronic, medically unexplained physical symptoms (MUPS). Although different medications are part of treatment routines for people with somatoform disorders in clinics and private practices, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications. We aimed to synthesise to improve optimal treatment decisions.\nObjectives\nTo assess the effects of pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, and pain disorder) in adults.\nSearch methods\nWe searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) (to 17 January 2014). This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). To identify ongoing trials, we searched ClinicalTrials.gov, Current Controlled Trials metaRegister, the World Health Organization International Clinical Trials Registry Platform, and the Chinese Clinical Trials Registry. For grey literature, we searched ProQuest Dissertation & Theses Database, OpenGrey, and BIOSIS Previews. We handsearched conference proceedings and reference lists of potentially relevant papers and systematic reviews and contacted experts in the field.\nSelection criteria\nWe selected RCTs or cluster RCTs of pharmacological interventions versus placebo, treatment as usual, another medication, or a combination of different medications for somatoform disorders in adults. We included people fulfilling standardised diagnostic criteria for somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, or somatoform pain disorder.\nData collection and analysis\nOne review author and one research assistant independently extracted data and assessed risk of bias. Primary outcomes included the severity of MUPS on a continuous measure, and acceptability of treatment.\nMain results\nWe included 26 RCTs (33 reports), with 2159 participants, in the review. They examined the efficacy of different types of antidepressants, the combination of an antidepressant and an antipsychotic, antipsychotics alone, or natural products (NPs). The duration of the studies ranged between two and 12 weeks.\nOne meta-analysis of placebo-controlled studies showed no clear evidence of a significant difference between tricyclic antidepressants (TCAs) and placebo for the outcome severity of MUPS (SMD -0.13; 95% CI -0.39 to 0.13; 2 studies, 239 participants; I2 = 2%; low-quality evidence). For new-generation antidepressants (NGAs), there was very low-quality evidence showing they were effective in reducing the severity of MUPS (SMD -0.91; 95% CI -1.36 to -0.46; 3 studies, 243 participants; I2 = 63%). For NPs there was low-quality evidence that they were effective in reducing the severity of MUPS (SMD -0.74; 95% CI -0.97 to -0.51; 2 studies, 322 participants; I2 = 0%).\nOne meta-analysis showed no clear evidence of a difference between TCAs and NGAs for severity of MUPS (SMD -0.16; 95% CI -0.55 to 0.23; 3 studies, 177 participants; I2 = 42%; low-quality evidence). There was also no difference between NGAs and other NGAs for severity of MUPS (SMD -0.16; 95% CI -0.45 to 0.14; 4 studies, 182 participants; I2 = 0%).\nFinally, one meta-analysis comparing selective serotonin reuptake inhibitors (SSRIs) with a combination of SSRIs and antipsychotics showed low-quality evidence in favour of combined treatment for severity of MUPS (SMD 0.77; 95% CI 0.32 to 1.22; 2 studies, 107 participants; I2 = 23%).\nDifferences regarding the acceptability of the treatment (rate of all-cause drop-outs) were neither found between NGAs and placebo (RR 1.01, 95% CI 0.64 to 1.61; 2 studies, 163 participants; I2 = 0%; low-quality evidence) or NPs and placebo (RR 0.85, 95% CI 0.40 to 1.78; 3 studies, 506 participants; I2 = 0%; low-quality evidence); nor between TCAs and other medication (RR 1.48, 95% CI 0.59 to 3.72; 8 studies, 556 participants; I2 =14%; low-quality evidence); nor between antidepressants and the combination of an antidepressant and an antipsychotic (RR 0.80, 95% CI 0.25 to 2.52; 2 studies, 118 participants; I2 = 0%; low-quality evidence). Percental attrition rates due to adverse effects were high in all antidepressant treatments (0% to 32%), but low for NPs (0% to 1.7%).\nThe risk of bias was high in many domains across studies. Seventeen trials (65.4%) gave no information about random sequence generation and only two (7.7%) provided information about allocation concealment. Eighteen studies (69.2%) revealed a high or unclear risk in blinding participants and study personnel; 23 studies had high risk of bias relating to blinding assessors. For the comparison NGA versus placebo, there was relatively high imprecision and heterogeneity due to one outlier study. Although we identified 26 studies, each comparison only contained a few studies and small numbers of participants so the results were imprecise.\nAuthors' conclusions\nThe current review found very low-quality evidence for NGAs and low-quality evidence for NPs being effective in treating somatoform symptoms in adults when compared with placebo. There was some evidence that different classes of antidepressants did not differ in efficacy; however, this was limited and of low to very low quality. These results had serious shortcomings such as the high risk of bias, strong heterogeneity in the data, and small sample sizes. Furthermore, the significant effects of antidepressant treatment have to be balanced against the relatively high rates of adverse effects. Adverse effects produced by medication can have amplifying effects on symptom perceptions, particularly in people focusing on somatic symptoms without medical causes. We can only draw conclusions about short-term efficacy of the pharmacological interventions because no trial included follow-up assessments. For each of the comparisons where there were available data on acceptability rates (NGAs versus placebo, NPs versus placebo, TCAs versus other medication, and antidepressants versus a combination of an antidepressant and an antipsychotic), no clear differences between the intervention and comparator were found.\nFuture high-quality research should be carried out to determine the effectiveness of medications other than antidepressants, to compare antidepressants more thoroughly, and to follow-up participants over longer periods (the longest follow up was just 12 weeks). Another idea for future research would be to include other outcomes such as functional impairment or dysfunctional behaviours and cognitions as well as the classical outcomes such as symptom severity, depression, or anxiety.\n\nGiven the provided abstract, please respond to the following query: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- What is the quality of current research on medication as a treatment for somatoform disorders?\n- Is medication an effective treatment for physical symptoms in somatoform disorders compared with placebo (dummy pill)?\n- Which types of medication are most effective?\n- Are natural products such as St. John's wort an effective treatment for somatoform disorders compared with placebo?\n- How well do people with somatoform disorders tolerate medication or natural products?"
}
]
|
query-laysum | 4096 | [
{
"role": "user",
"content": "Abstract: Background\nIvermectin, an antiparasitic agent, inhibits the replication of viruses in vitro. The molecular hypothesis of ivermectin's antiviral mode of action suggests an inhibitory effect on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in early stages of infection. Currently, evidence on ivermectin for prevention of SARS-CoV-2 infection and COVID-19 treatment is conflicting.\nObjectives\nTo assess the efficacy and safety of ivermectin plus standard of care compared to standard of care plus/minus placebo, or any other proven intervention for people with COVID-19 receiving treatment as inpatients or outpatients, and for prevention of an infection with SARS-CoV-2 (postexposure prophylaxis).\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, Web of Science (Emerging Citation Index and Science Citation Index), WHO COVID-19 Global literature on coronavirus disease, and HTA database weekly to identify completed and ongoing trials without language restrictions to 16 December 2021. Additionally, we included trials with > 1000 participants up to April 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing ivermectin to standard of care, placebo, or another proven intervention for treatment of people with confirmed COVID-19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS-CoV-2 infection. Co-interventions had to be the same in both study arms.\nFor this review update, we reappraised eligible trials for research integrity: only RCTs prospectively registered in a trial registry according to WHO guidelines for clinical trial registration were eligible for inclusion.\nData collection and analysis\nWe assessed RCTs for bias, using the Cochrane RoB 2 tool. We used GRADE to rate the certainty of evidence for outcomes in the following settings and populations: 1) to treat inpatients with moderate-to-severe COVID-19, 2) to treat outpatients with mild COVID-19 (outcomes: mortality, clinical worsening or improvement, (serious) adverse events, quality of life, and viral clearance), and 3) to prevent SARS-CoV-2 infection (outcomes: SARS-CoV-2 infection, development of COVID-19 symptoms, admission to hospital, mortality, adverse events and quality of life).\nMain results\nWe excluded seven of the 14 trials included in the previous review version; six were not prospectively registered and one was non-randomized. This updated review includes 11 trials with 3409 participants investigating ivermectin plus standard of care compared to standard of care plus/minus placebo. No trial investigated ivermectin for prevention of infection or compared ivermectin to an intervention with proven efficacy. Five trials treated participants with moderate COVID-19 (inpatient settings); six treated mild COVID-19 (outpatient settings). Eight trials were double-blind and placebo-controlled, and three were open-label. We assessed around 50% of the trial results as low risk of bias.\nWe identified 31 ongoing trials. In addition, there are 28 potentially eligible trials without publication of results, or with disparities in the reporting of the methods and results, held in ‘awaiting classification’ until the trial authors clarify questions upon request.\nIvermectin for treating COVID-19 in inpatient settings with moderate-to-severe disease\nWe are uncertain whether ivermectin plus standard of care compared to standard of care plus/minus placebo reduces or increases all-cause mortality at 28 days (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.14 to 2.51; 3 trials, 230 participants; very low-certainty evidence); or clinical worsening, assessed by participants with new need for invasive mechanical ventilation or death at day 28 (RR 0.82, 95% CI 0.33 to 2.04; 2 trials, 118 participants; very low-certainty evidence); or serious adverse events during the trial period (RR 1.55, 95% CI 0.07 to 35.89; 2 trials, 197 participants; very low-certainty evidence). Ivermectin plus standard of care compared to standard of care plus placebo may have little or no effect on clinical improvement, assessed by the number of participants discharged alive at day 28 (RR 1.03, 95% CI 0.78 to 1.35; 1 trial, 73 participants; low-certainty evidence); on any adverse events during the trial period (RR 1.04, 95% CI 0.61 to 1.79; 3 trials, 228 participants; low-certainty evidence); and on viral clearance at 7 days (RR 1.12, 95% CI 0.80 to 1.58; 3 trials, 231 participants; low-certainty evidence). No trial investigated quality of life at any time point.\nIvermectin for treating COVID-19 in outpatient settings with asymptomatic or mild disease\nIvermectin plus standard of care compared to standard of care plus/minus placebo probably has little or no effect on all-cause mortality at day 28 (RR 0.77, 95% CI 0.47 to 1.25; 6 trials, 2860 participants; moderate-certainty evidence) and little or no effect on quality of life, measured with the PROMIS Global-10 scale (physical component mean difference (MD) 0.00, 95% CI -0.98 to 0.98; and mental component MD 0.00, 95% CI -1.08 to 1.08; 1358 participants; high-certainty evidence). Ivermectin may have little or no effect on clinical worsening, assessed by admission to hospital or death within 28 days (RR 1.09, 95% CI 0.20 to 6.02; 2 trials, 590 participants; low-certainty evidence); on clinical improvement, assessed by the number of participants with all initial symptoms resolved up to 14 days (RR 0.90, 95% CI 0.60 to 1.36; 2 trials, 478 participants; low-certainty evidence); on serious adverse events (RR 2.27, 95% CI 0.62 to 8.31; 5 trials, 1502 participants; low-certainty evidence); on any adverse events during the trial period (RR 1.24, 95% CI 0.87 to 1.76; 5 trials, 1502 participants; low-certainty evidence); and on viral clearance at day 7 compared to placebo (RR 1.01, 95% CI 0.69 to 1.48; 2 trials, 331 participants; low-certainty evidence). None of the trials reporting duration of symptoms were eligible for meta-analysis.\nAuthors' conclusions\nFor outpatients, there is currently low- to high-certainty evidence that ivermectin has no beneficial effect for people with COVID-19. Based on the very low-certainty evidence for inpatients, we are still uncertain whether ivermectin prevents death or clinical worsening or increases serious adverse events, while there is low-certainty evidence that it has no beneficial effect regarding clinical improvement, viral clearance and adverse events. No evidence is available on ivermectin to prevent SARS-CoV-2 infection. In this update, certainty of evidence increased through higher quality trials including more participants. According to this review's living approach, we will continually update our search.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomized controlled trials that investigated ivermectin to prevent or treat COVID-19. People treated in hospital or as outpatients had to have laboratory-confirmed COVID-19.\nIn this update, we also investigated the trustworthiness of the trials and only included them if they fulfilled clear ethical and scientific criteria.\nWe compared and summarized the results of the trials and rated our confidence in the evidence, based on common criteria such as trial methods and sizes."
}
]
|
query-laysum | 4097 | [
{
"role": "user",
"content": "Abstract: Background\nBranched-chain amino acids (BCAAs) play a vital role in neonatal nutrition. Optimal BCAA supplementation might improve neonatal nutrient storage, leading to better physical and neurological development and other outcomes.\nObjectives\nTo determine the effect of BCAA supplementation on physical growth and neurological development in term and preterm neonates. We planned to make the following comparisons: parenteral nutrition with and without BCAA supplementation; enteral BCAA supplementation versus no supplementation; and any type of supplementation including enteral, parenteral and both ways versus no supplementation.\nTo investigate the supplementation effectiveness for different dosages assessed in the eligible trials.\nSearch methods\nWe conducted comprehensive searches using Cochrane Neonatal's standard search strategies: Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 6), MEDLINE, Embase and CINAHL (up to July 2016). We updated the search with CENTRAL (2019, Issue 8), MEDLINE, Embase and CINAHL (up to August 2019). We also searched clinical trials registries and reference lists of retrieved articles.\nSelection criteria\nWe planned to include individual and cluster-randomised and quasi-randomised controlled trials comparing BCAA supplementation versus placebo or no supplementation in term and preterm neonates. We excluded trials presented only as abstracts and cross-over trials.\nData collection and analysis\nTwo review authors independently assessed the eligibility of all potential studies identified from the search strategy. We planned to extract data using a pilot-tested standard data extraction form and assess risk of bias of the included studies following the methods described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to analyse treatment effects and report their effect estimates as per dichotomous or continuous data with 95% confidence intervals. We planned to conduct subgroup analysis to investigate heterogeneity, and perform sensitivity analysis where possible. We planned to use fixed-effect meta-analysis to combine data wherever appropriate. We planned to assess evidence quality using the GRADE approach.\nMain results\nWe did not identify any potentially eligible studies that met the inclusion criteria in this review.\nAuthors' conclusions\nWe found no trial data to support or refute the idea that BCAA supplementation affects physical and neurological development and other outcomes in term and preterm neonates.\n\nGiven the provided abstract, please respond to the following query: \"Key results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is unable to suggest the effect of BCAA supplementation on physical growth and neurological development in term and preterm neonates. Future studies are required as this assessment is very important in the neonatal field."
}
]
|
query-laysum | 4098 | [
{
"role": "user",
"content": "Abstract: Background\nChronic anticoagulation with vitamin K antagonists (VKAs) prevents ischaemic stroke and systemic embolism in people with non-valvular atrial fibrillation (AF) but dose adjustment, coagulation monitoring and bleeding limits its use. Direct thrombin inhibitors (DTIs) are under investigation as potential alternatives.\nObjectives\nTo assess (1) the comparative efficacy of long-term anticoagulation using DTIs versus VKAs on vascular deaths and ischaemic events in people with non-valvular AF, and (2) the comparative safety of chronic anticoagulation using DTIs versus VKAs on (a) fatal and non-fatal major bleeding events including haemorrhagic strokes, (b) adverse events other than bleeding and ischaemic events that lead to treatment discontinuation and (c) all-cause mortality in people with non-valvular AF.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, May 2013), MEDLINE (1950 to July 2013), EMBASE (1980 to October 2013), LILACS (1982 to October 2013) and trials registers (September 2013). We also searched the websites of clinical trials and pharmaceutical companies and handsearched the reference lists of articles and conference proceedings.\nSelection criteria\nRandomised controlled trials (RCTs) comparing DTIs versus VKAs for prevention of stroke and systemic embolism in people with non-valvular AF.\nData collection and analysis\nAll three review authors independently performed data extraction and assessment of risk of bias. Primary analyses compared all DTIs combined versus warfarin. We performed post hoc analyses excluding ximelagatran because this drug was withdrawn from the market owing to safety concerns.\nMain results\nWe included eight studies involving a total of 27,557 participants with non-valvular AF and one or more risk factors for stroke; 26,601 of them were assigned to standard doses groups and included in the primary analysis. The DTIs: dabigatran 110 mg twice daily and 150 mg twice daily (three studies, 12,355 participants), AZD0837 300 mg once per day (two studies, 233 participants) and ximelagatran 36 mg twice per day (three studies, 3726 participants) were compared with the VKA warfarin (10,287 participants). Overall risk of bias and statistical heterogeneity of the studies included were low.\nThe odds of vascular death and ischaemic events were not significantly different between all DTIs and warfarin (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.85 to 1.05). Sensitivity analysis by dose of dabigatran on reduction in ischaemic events and vascular mortality indicated that dabigatran 150 mg twice daily was superior to warfarin although the effect estimate was of borderline statistical significance (OR 0.86, 95% CI 0.75 to 0.99). Sensitivity analyses by other factors did not alter the results. Fatal and non-fatal major bleeding events, including haemorrhagic strokes, were less frequent with the DTIs (OR 0.87, 95% CI 0.78 to 0.97). Adverse events that led to discontinuation of treatment were significantly more frequent with the DTIs (OR 2.18, 95% CI 1.82 to 2.61). All-cause mortality was similar between DTIs and warfarin (OR 0.91, 95% CI 0.83 to 1.01).\nAuthors' conclusions\nDTIs were as efficacious as VKAs for the composite outcome of vascular death and ischaemic events and only the dose of dabigatran 150 mg twice daily was found to be superior to warfarin. DTIs were associated with fewer major haemorrhagic events, including haemorrhagic strokes. Adverse events that led to discontinuation of treatment occurred more frequently with the DTIs. We detected no difference in death from all causes.\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 eight studies, identified up to October 2013, evaluating the effect of DTIs versus warfarin in people with non-valvular AF. DTIs included were dabigatran 110 mg or 150 mg twice daily (three studies, 12,355 participants), AZD0837 300 mg once a day (two studies, 233 participants) and ximelagatran 36 mg twice daily (three studies, 3726 participants). Of the total number of participants included in this review 61% were men, and the mean age of participants in all studies was over 70 years. Follow-up periods after the end of study medication ranged from zero to four weeks."
}
]
|
query-laysum | 4099 | [
{
"role": "user",
"content": "Abstract: Background\nChronic lung disease (CLD) remains a common complication among preterm infants. There is increasing evidence that inflammation plays an important role in the pathogenesis of CLD. Due to their strong anti-inflammatory properties, corticosteroids are an attractive intervention strategy. However, there are growing concerns regarding short- and long-term effects of systemic corticosteroids. Theoretically, administration of inhaled corticosteroids may allow for beneficial effects on the pulmonary system with a lower risk of undesirable systemic side effects.\nObjectives\nTo determine the impact of inhaled corticosteroids administered to preterm infants with birth weight up to 1500 grams (VLBW) beginning in the first two weeks after birth for the prevention of CLD as reflected by the requirement for supplemental oxygen at 36 weeks' postmenstrual age (PMA).\nSearch methods\nRandomised and quasi-randomised trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12) in the Cochrane Library (searched 5 January 2016), MEDLINE (1966 to 5 January 2016), Embase (1980 to 5 January 2016), CINAHL (1982 to 5 January 2016), reference lists of published trials and abstracts published in Pediatric Research or electronically on the Pediatric Academic Societies web-site (1990 to May 2016).\nSelection criteria\nWe included in this review randomised controlled trials of inhaled corticosteroid therapy initiated within the first two weeks of life in VLBW preterm infants.\nData collection and analysis\nWe evaluated data regarding clinical outcomes, including: CLD at 28 days or 36 weeks' PMA; mortality; combined outcome of death or CLD at 28 days of age and at 36 weeks' PMA; the need for systemic corticosteroids; failure to extubate within 14 days; and adverse effects of corticosteroids. All data were analysed using Review Manager (RevMan) 5. Meta-analyses were performed using relative risk (RR) and risk difference (RD), along with their 95% confidence intervals (CI). If RD was significant, the number needed to treat for an additional beneficial outcome (NNTB) was calculated. We used the GRADE approach to assess the quality of evidence.\nMain results\nAccording to GRADE the quality of the studies was moderate. Three additional trials are included in this update. The present review includes data analyses based on 10 qualifying trials that enrolled 1644 neonates. There was no significant difference in the incidence of CLD at 36 weeks' PMA in the inhaled steroid versus the placebo group (5 trials, 429 neonates) among all randomised (typical RR 0.97, 95% CI 0.62 to 1.52; typical RD −0.00, 95% CI −0.07 to 0.06). There was no heterogeneity for this outcome (typical RR I² = 11%; typical RD I² = 0%). There was a significant reduction in the incidence of CLD at 36 weeks' PMA among survivors (6 trials, 1088 neonates) (typical RR 0.76, 95% CI 0.63 to 0.93; typical RD −0.07, 95% CI −0.13 to −0.02; NNTB 14, 95% CI 8 to 50). There was a significant reduction in the combined outcome of death or CLD at 36 weeks' PMA among all randomised neonates (6 trials, 1285 neonates) (typical RR 0.86, 95% CI 0.75 to 0.99; typical RD −0.06, 95% CI −0.11 to −0.00) (P = 0.04); NNTB 17, 95% CI 9 to infinity). There was no significant heterogeneity for any of these analyses (I² = 0%). A lower rate of reintubation was noted in the inhaled steroid group compared with the control group in one study. There were no statistically significant differences in short-term complications between groups and no differences in adverse events at long-term follow-up reported. Long-term follow-up of infants enrolled in the study by Bassler 2015 is ongoing.\nAuthors' conclusions\nBased on this updated review, there is increasing evidence from the trials reviewed that early administration of inhaled steroids to VLBW neonates is effective in reducing the incidence of death or CLD at 36 weeks' PMA among either all randomised infants or among survivors. Even though there is statistical significance, the clinical relevance is of question as the upper CI limit for the outcome of death or CLD at 36 weeks' PMA is infinity. The long-term follow-up results of the Bassler 2015 study may affect the conclusions of this review. Further studies are needed to identify the risk/benefit ratio of different delivery techniques and dosing schedules for the administration of these medications. Studies need to address both the short- and long-term benefits and adverse effects of inhaled steroids with particular attention to neurodevelopmental outcome.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In general the quality of the studies was good."
}
]
|
query-laysum | 4100 | [
{
"role": "user",
"content": "Abstract: Background\nGabapentin is commonly used to treat neuropathic pain (pain due to nerve damage). This review updates a review published in 2014, and previous reviews published in 2011, 2005 and 2000.\nObjectives\nTo assess the analgesic efficacy and adverse effects of gabapentin in chronic neuropathic pain in adults.\nSearch methods\nFor this update we searched CENTRAL), MEDLINE, and Embase for randomised controlled trials from January 2014 to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trials registries.\nSelection criteria\nWe included randomised, double-blind trials of two weeks' duration or longer, comparing gabapentin (any route of administration) with placebo or another active treatment for neuropathic pain, with participant-reported pain assessment.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)), or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC). We performed a pooled analysis for any substantial or moderate benefit. Where pooled analysis was possible, we used dichotomous data to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH). We assessed the quality of the evidence using GRADE and created 'Summary of findings' tables.\nMain results\nWe included four new studies (530 participants), and excluded three previously included studies (126 participants). In all, 37 studies provided information on 5914 participants. Most studies used oral gabapentin or gabapentin encarbil at doses of 1200 mg or more daily in different neuropathic pain conditions, predominantly postherpetic neuralgia and painful diabetic neuropathy. Study duration was typically four to 12 weeks. Not all studies reported important outcomes of interest. High risk of bias occurred mainly due to small size (especially in cross-over studies), and handling of data after study withdrawal.\nIn postherpetic neuralgia, more participants (32%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (17%) (RR 1.8 (95% CI 1.5 to 2.1); NNT 6.7 (5.4 to 8.7); 8 studies, 2260 participants, moderate-quality evidence). More participants (46%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (25%) (RR 1.8 (95% CI 1.6 to 2.0); NNT 4.8 (4.1 to 6.0); 8 studies, 2260 participants, moderate-quality evidence).\nIn painful diabetic neuropathy, more participants (38%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (23%) (RR 1.7 (95% CI 1.4 to 2.0); NNT 6.6 (5.0 to 10); 6 studies, 1331 participants, moderate-quality evidence). More participants (52%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (37%) (RR 1.4 (95% CI 1.3 to 1.6); NNT 6.6 (4.9 to 9.9); 7 studies, 1439 participants, moderate-quality evidence).\nFor all conditions combined, adverse event withdrawals were more common with gabapentin (11%) than with placebo (8.2%) (RR 1.4 (95% CI 1.1 to 1.7); NNH 30 (20 to 65); 22 studies, 4346 participants, high-quality evidence). Serious adverse events were no more common with gabapentin (3.2%) than with placebo (2.8%) (RR 1.2 (95% CI 0.8 to 1.7); 19 studies, 3948 participants, moderate-quality evidence); there were eight deaths (very low-quality evidence). Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4); NNH 7.5 (6.1 to 9.6); 18 studies, 4279 participants, moderate-quality evidence). Individual adverse events occurred significantly more often with gabapentin. Participants taking gabapentin experienced dizziness (19%), somnolence (14%), peripheral oedema (7%), and gait disturbance (14%).\nAuthors' conclusions\nGabapentin at doses of 1800 mg to 3600 mg daily (1200 mg to 3600 mg gabapentin encarbil) can provide good levels of pain relief to some people with postherpetic neuralgia and peripheral diabetic neuropathy. Evidence for other types of neuropathic pain is very limited. The outcome of at least 50% pain intensity reduction is regarded as a useful outcome of treatment by patients, and the achievement of this degree of pain relief is associated with important beneficial effects on sleep interference, fatigue, and depression, as well as quality of life, function, and work. Around 3 or 4 out of 10 participants achieved this degree of pain relief with gabapentin, compared with 1 or 2 out of 10 for placebo. Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events. Conclusions have not changed since the previous update 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": "In pain after shingles, 3 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 3 in 10 with placebo. In pain caused by diabetes, 4 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 4 in 10 with placebo. There was no reliable evidence for any other type of neuropathic pain.\nSide effects were more common with gabapentin (6 in 10) than with placebo (5 in 10). Dizziness, sleepiness, water retention, and problems with walking each occurred in about 1 in 10 people who took gabapentin. Serious side effects were uncommon, and not different between gabapentin and placebo. Slightly more people taking gabapentin stopped taking it because of side effects.\nGabapentin is helpful for some people with chronic neuropathic pain. It is not possible to know beforehand who will benefit and who will not. Current knowledge suggests that a short trial is the best way of telling."
}
]
|
query-laysum | 4101 | [
{
"role": "user",
"content": "Abstract: Background\nLow-molecular-weight heparins (LMWHs) and heparinoids are anticoagulants that may have more powerful antithrombotic effects than standard unfractionated heparin (UFH) but a lower risk of bleeding complications. This is an update of the original Cochrane Review of these agents, first published in 2001 and last updated in 2008.\nObjectives\nTo determine whether antithrombotic therapy with LMWHs or heparinoids is associated with a reduction in the proportion of people who are dead or dependent for activities in daily living compared with UFH.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL: the Cochrane Library Issue 1, 2017), MEDLINE (1966 to February 2017), and Embase (1980 to February 2017). We also searched trials registers to February 2017: ClinicalTrials.gov, EU Clinical Trials Register, Stroke Trials Registry, ISRCTN Registry and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nUnconfounded randomised trials comparing LMWH or heparinoids with standard UFH in people with acute ischaemic stroke, in which participants were recruited within 14 days of stroke onset.\nData collection and analysis\nTwo review authors independently chose studies for inclusion, assessed risk of bias and trial quality, extracted and analysed the data. Differences were resolved by discussion.\nMain results\nWe included nine trials involving 3137 participants. We did not identify any new trials for inclusion in this updated review. None of the studies reported data on the primary outcome in sufficient detail to enable analysis for the review. Overall, there was a moderate risk of bias in the included studies. Compared with UFH, there was no evidence of an effect of LMWH or heparinoids on death from all causes during the treatment period (96/1616 allocated LMWH/heparinoid versus 78/1486 allocated UFH; odds ratio (OR) 1.06, 95% CI 0.78 to 1.47; 8 trials, 3102 participants, low quality evidence). LMWH or heparinoid were associated with a significant reduction in deep vein thrombosis (DVT) compared with UFH (OR 0.55, 95% CI 0.44 to 0.70, 7 trials, 2585 participants, low quality evidence). However, the number of the major clinical events such as pulmonary embolism (PE) and intracranial haemorrhage was too small to provide a reliable estimate of the effects.\nAuthors' conclusions\nTreatment with a LMWH or heparinoid after acute ischaemic stroke appears to decrease the occurrence of DVT compared with standard UFH, but there are too few data to provide reliable information on their effects on other important outcomes, including functional outcome, death and intracranial haemorrhage.\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": "Stroke is a common and disabling disease. Sudden blockage of an artery to the brain, often caused by a blood clot, is the cause of the most common type of stroke. This type is called an ischaemic stroke. Anticoagulants (blood-thinning drugs), are widely used in people with stroke. As stroke is a medical emergency, and medicines given in an emergency need to reach the bloodstream quickly, these are given by injection. Injectable anticoagulants that have been tested in stroke are unfractionated heparin (UFH), low-molecular-weight heparins (LMWH), and heparinoids. These agents may help clear blocked arteries, prevent re-blockage, and prevent clots forming in leg veins (deep vein thrombosis, DVT) after an ischaemic stroke and so might prevent fatal or disabling complications of stroke and improve the chance of a good recovery. However, they can also cause harmful bleeding complications that can offset any benefits."
}
]
|
query-laysum | 4102 | [
{
"role": "user",
"content": "Abstract: Background\nScreening programmes can potentially identify people at high cardiovascular risk and reduce cardiovascular disease (CVD) morbidity and mortality. However, there is currently not enough evidence showing clear clinical or economic benefits of systematic screening-like programmes over the widely practised opportunistic risk assessment of CVD in primary care settings.\nObjectives\nThe primary objective of this review was to assess the effectiveness, costs and adverse effects of systematic risk assessment compared to opportunistic risk assessment for the primary prevention of CVD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, MEDLINE, EMBASE on 30 January 2015, and Web of Science Core Collection and additional databases on the Cochrane Library on 4 December 2014. We also searched two clinical trial registers and checked reference lists of relevant articles. We applied no language restrictions.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that assessed the effects of systematic risk assessment, defined as a screening-like programme involving a predetermined selection process of people, compared with opportunistic risk assessment which ranged from no risk assessment at all to incentivised case finding of CVD and related risk factors. Participants included healthy adults from the general population, including those who are at risk of CVD.\nData collection and analysis\nTwo review authors independently selected studies. One review author extracted data and assessed them for risk of bias and a second checked them. We assessed evidence quality using the GRADE approach and present this in a ’Summary of findings’ table.\nMain results\nNine completed RCTs met the inclusion criteria, of which four were cluster-randomised. We also identified five ongoing trials. The included studies had a high or unclear risk of bias, and the GRADE ratings of overall quality were low or very low. The length of follow-up varied from one year in four studies, three years in one study, five or six years in two studies, and ten years in two studies. Eight studies recruited participants from the general population, although there were differences in the age ranges targeted. One study recruited family members of cardiac patients (high risk assessment). There were considerable differences between the studies in the interventions received by the intervention and control groups. There was insufficient evidence to stratify by the types of risk assessment approaches.\nLimited data were available on all-cause mortality (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93 to 1.03; 3 studies,103,571 participants, I² = 0%; low-quality evidence) and cardiovascular mortality (RR 1.00, 95% CI 0.90 to 1.11; 2 studies, 43,955 participants, I² = 0%), and suggest that screening has no effect on these outcomes. Data were also limited for combined non-fatal endpoints; overall, evidence indicates no difference in total coronary heart disease (RR 1.01, 95% CI 0.95 to 1.07; 4 studies, 5 comparisons, 110,168 participants, I² = 0%; low-quality evidence), non-fatal coronary heart disease (RR 0.98, 95% CI 0.89 to 1.09; 2 studies, 43,955 participants, I² = 39%), total stroke (RR 0.99, 95% CI 0.90 to 1.10; 2 studies, 79,631 participants, I² = 0%, low-quality evidence), and non-fatal stroke (RR 1.17, 95% CI 0.94 to 1.47; 1 study, 20,015 participants).\nOverall, systematic risk assessment appears to result in lower total cholesterol levels (mean difference (MD) -0.11 mmol/l, 95% CI -0.17 to -0.04, 6 studies, 7 comparisons, 12,591 participants, I² = 57%; very low-quality evidence), lower systolic blood pressure (MD -3.05 mmHg, 95% CI -4.84 to -1.25, 6 studies, 7 comparisons, 12,591 participants, I² = 82%; very low-quality evidence) and lower diastolic blood pressure (MD -1.34 mmHg, 95% CI -1.76 to -0.93, 6 studies, 7 comparisons, 12,591 participants, I² = 0%; low-quality evidence). One study assessed adverse effects and found no difference in psychological distress at five years (1126 participants).\nAuthors' conclusions\nThe results are limited by the heterogeneity between trials in terms of participants recruited, interventions and duration of follow-up. Limited data suggest that systematic risk assessment for CVD has no statistically significant effects on clinical endpoints. There is limited evidence to suggest that CVD systematic risk assessment may have some favourable effects on cardiovascular risk factors. The completion of the five ongoing trials will add to the evidence base.\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": "Nine trials met our inclusion criteria. Limited data suggest that screening has no effect on deaths (from any cause) or the number of people having a stroke or developing coronary heart disease. Data were also limited for cardiovascular risk factors (blood lipids and blood pressure) where there were some favourable effects with systematic risk assessment, but there were differences between studies and so results are not certain."
}
]
|
query-laysum | 4103 | [
{
"role": "user",
"content": "Abstract: Background\nLactoferrin, a normal component of human colostrum and milk, can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis (NEC) in preterm neonates.\nObjectives\nTo assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates. Secondarily, we assessed the effects of lactoferrin supplementation to enteral feeds on the duration of positive-pressure ventilation, development of chronic lung disease (CLD) or periventricular leukomalacia (PVL), length of hospital stay to discharge among survivors, and adverse neurological outcomes at two years of age or later.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to update our search. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 9), MEDLINE via PubMed (1966 to 20 January 2020), PREMEDLINE (1996 to 20 January 2020), Embase (1980 to 20 January 2020), and CINAHL (1982 to 20 January 2020). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nIn our search, we included randomized controlled trials (RCTs) evaluating enteral lactoferrin supplementation at any dose or duration to prevent sepsis or NEC in preterm neonates.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal and the GRADE approach to assess the certainty of evidence.\nMain results\nMeta-analysis of data from twelve randomized controlled trials showed that lactoferrin supplementation to enteral feeds decreased suspected or confirmed late-onset sepsis (typical RR 0.80, 95% CI 0.72 to 0.89; typical RD -0.05, 95% CI, -0.07 to -0.02; NNTB 20, 95% CI 14 to 50; 12 studies, 5425 participants, low-certainty evidence) and decreased length of hospital stay (MD -2.38 to 95% CI, -4.67 to -0.09; 3 studies, 1079 participants, low-certainty evidence). A subgroup analysis including data of infants with confirmed sepsis demonstrates a decrease in confirmed late-onset sepsis (typical RR 0.83, 95% CI 0.73 to 0.94; typical RD -0.03, 95% CI, -0.04 to -0.01; NNTB 33, 95% CI 25 to 100; 12 studies, 5425 participants, low-certainty evidence).\nSensitivity analysis including only good methodological certainty studies suggested a decrease in late-onset sepsis (both suspected and confirmed) with enteral lactoferrin supplementation (typical RR 0.82, 95% CI, 0.74 to 0.91; typical RD -0.04, 95% CI, -0.06 to -0.02; NNTB 20, 95% CI 14 to 50; 9 studies, 4702 participants, low-certainty evidence).\nThere were no differences in NEC stage II or III (typical RR 1.10, 95% CI, 0.86 to 1.41; typical RD -0.00, 95% CI, -0.02 to 0.01; 7 studies, 4874 participants; low-certainty evidence) or 'all-cause mortality' (typical RR 0.90, 95% CI 0.69 to 1.17; typical RD -0.00, 95% CI, -0.01 to 0.01; 11 studies, 5510 participants; moderate-certainty evidence). One study reported no differences in neurodevelopmental testing by Mullen's or Bayley III at 24 months of age after enteral lactoferrin supplementation (one study, 292 participants, low-certainty evidence).\nLactoferrin supplementation to enteral feeds with probiotics decreased late-onset sepsis (RR 0.25, 95% CI 0.14 to 0.46; RD -0.13, 95% CI -0.18 to -0.08; NNTB 8, 95% CI 6 to 13; 3 studies, 564 participants; low-certainty evidence) and NEC stage II or III (RR 0.04, 95% CI 0.00 to 0.62; RD -0.05, 95% CI -0.08 to -0.03; NNTB 20, 95% CI 12.5 to 33.3; 1 study, 496 participants; very low-certainty evidence), but not 'all-cause mortality' (very low-certainty evidence).\nLactoferrin supplementation to enteral feeds with or without probiotics had no effect on CLD, duration of mechanical ventilation or threshold retinopathy of prematurity (low-certainty evidence). Investigators reported no adverse effects in the included studies.\nAuthors' conclusions\nWe found low-certainty evidence from studies of good methodological quality that lactoferrin supplementation of enteral feeds decreases late-onset sepsis (both suspected and confirmed, and confirmed only) but not NEC ≥ stage II or 'all cause mortality' or neurodevelopmental outcomes at 24 months of age in preterm infants without adverse effects. Low- to very low-certainty evidence suggests that lactoferrin supplementation of enteral feeds in combination with probiotics decreases late-onset sepsis (data from confirmed sepsis only) and NEC ≥ stage II in preterm infants without adverse effects, however, there were few included studies of poor methodological quality. The presence of publication bias and small studies of poor methodology that may inflate the effect size make recommendations for clinical practice difficult.\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": "Preterm babies are at risk for blood infection (sepsis) and/or gastrointestinal injury (necrotizing enterocolitis, or NEC). Many babies with sepsis or NEC die or develop long-term brain and lung injury despite treatment with antibiotics. Lactoferrin, a protein that is present in human milk, has been shown to be effective against infection when tested in animals and in the laboratory. Lactoferrin also enhances the ability of babies to fight infection."
}
]
|
query-laysum | 4104 | [
{
"role": "user",
"content": "Abstract: Background\nChronic kidney disease (CKD) is defined as reduced function of the kidneys present for 3 months or longer with adverse implications for health and survival. For several decades low protein diets have been proposed for participants with CKD with the aim of slowing the progression to end-stage kidney disease (ESKD) and delaying the onset of renal replacement therapy. However the relative benefits and harms of dietary protein restriction for preventing progression of CKD have not been resolved. This is an update of a systematic review first published in 2000 and updated in 2006, 2009, and 2018.\nObjectives\nTo determine the efficacy of low protein diets in preventing the natural progression of CKD towards ESKD and in delaying the need for commencing dialysis treatment in non-diabetic adults.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 7 September 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi RCTs in which adults with non-diabetic CKD (stages 3 to 5) not on dialysis were randomised to receive a very low protein intake (0.3 to 0.4 g/kg/day) compared with a low protein intake (0.5 to 0.6 g/kg/day) or a low protein intake compared with a normal protein intake (≥ 0.8 g/kg/day) for 12 months or more.\nData collection and analysis\nTwo authors independently selected studies and extracted data. For dichotomous outcomes (death, all causes), requirement for dialysis, adverse effects) the risk ratios (RR) with 95% confidence intervals (CI) were calculated and summary statistics estimated using the random effects model. Where continuous scales of measurement were used (glomerular filtration rate (GFR), weight), these data were analysed as the mean difference (MD) or standardised mean difference (SMD) if different scales had been used. The certainty of the evidence was assessed using GRADE.\nMain results\nWe identified 17 studies with 2996 analysed participants (range 19 to 840). Four larger multicentre studies were subdivided according to interventions so that the review included 21 separate data sets. Mean duration of participant follow-up ranged from 12 to 50 months.\nRandom sequence generation and allocation concealment were considered at low risk of bias in eleven and nine studies respectively. All studies were considered at high risk for performance bias as they were open-label studies. We assessed detection bias for outcome assessment for GFR and ESKD separately. As GFR measurement was a laboratory outcome all studies were assessed at low risk of detection bias. For ESKD, nine studies were at low risk of detection bias as the need to commence dialysis was determined by personnel independent of the study investigators. Five studies were assessed at high risk of attrition bias with eleven studies at low risk. Ten studies were at high risk for reporting bias as they did not include data which could be included in a meta-analysis. Eight studies reported funding from government bodies while the remainder did not report on funding.\nTen studies compared a low protein diet with a normal protein diet in participants with CKD categories 3a and b (9 studies) or 4 (one study). There was probably little or no difference in the numbers of participants who died (5 studies 1680 participants: RR 0.77, 95% CI 0.51 to 1.18; 13 fewer deaths per 1000; moderate certainty evidence). A low protein diet may make little or no difference in the number of participants who reached ESKD compared with a normal protein diet (6 studies, 1814 participants: RR 1.05, 95% CI 0.73 to 1.53; 7 more per 1000 reached ESKD; low certainty evidence). It remains uncertain whether a low protein diet compared with a normal protein intake impacts on the outcome of final or change in GFR (8 studies, 1680 participants: SMD -0.18, 95% CI -0.75 to 0.38; very low certainty evidence).\nEight studies compared a very low protein diet with a low protein diet and two studies compared a very low protein diet with a normal protein diet. A very low protein intake compared with a low protein intake probably made little or no difference to death (6 studies, 681 participants: RR 1.26, 95% CI 0.62 to 2.54; 10 more deaths per 1000; moderate certainty evidence). However it probably reduces the number who reach ESKD (10 studies, 1010 participants: RR 0.65, 95% CI 0.49 to 0.85; 165 per 1000 fewer reached ESKD; moderate certainty evidence). It remains uncertain whether a very low protein diet compared with a low or normal protein intake influences the final or change in GFR (6 studies, 456 participants: SMD 0.12, 95% CI -0.27 to 0.52; very low certainty evidence).\nFinal body weight was reported in only three studies. It is uncertain whether the intervention alters final body weight (3 studies, 89 participants: MD -0.40 kg, 95% CI -6.33 to 5.52; very low certainty evidence).Twelve studies reported no evidence of protein energy wasting (malnutrition) in their study participants while three studies reported small numbers of participants in each group with protein energy wasting. Most studies reported that adherence to diet was satisfactory. Quality of life was not formally assessed in any studies.\nAuthors' conclusions\nThis review found that very low protein diets probably reduce the number of people with CKD 4 or 5, who progress to ESKD. In contrast low protein diets may make little difference to the number of people who progress to ESKD. Low or very low protein diets probably do not influence death. However there are limited data on adverse effects such as weight differences and protein energy wasting. There are no data on whether quality of life is impacted by difficulties in adhering to protein restriction. Studies evaluating the adverse effects and the impact on quality of life of dietary protein restriction are required before these dietary approaches can be recommended for widespread use.\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 examined the evidence from 17 studies (21 data sets) with 2996 people with reduced kidney function. We found that very low protein diets compared with low or normal protein intakes probably reduce the number of people with advanced kidney failure, who progress to dialysis. When low protein diets were compared with normal protein diets, there was little of no difference in the number of people with less severe kidney failure, who progressed to dialysis. Side effects of low protein diets such as weight loss were uncommon but many studies did not report on side effects."
}
]
|
query-laysum | 4105 | [
{
"role": "user",
"content": "Abstract: Background\nBronchopulmonary dysplasia (BPD), defined as oxygen dependence at 36 weeks' postmenstrual age (PMA), remains an important complication of prematurity. Pulmonary inflammation plays a central role in the pathogenesis of BPD. Attenuating pulmonary inflammation with postnatal systemic corticosteroids reduces the incidence of BPD in preterm infants but may be associated with an increased risk of adverse neurodevelopmental outcomes. Local administration of corticosteroids via inhalation may be an effective and safe alternative.\nObjectives\nTo assess the benefits and harms of inhaled corticosteroids versus placebo, initiated between seven days of postnatal life and 36 weeks' postmenstrual age, to preterm infants at risk of developing bronchopulmonary dysplasia.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, and three trials registries to August 2022. We searched conference proceedings and the reference lists of retrieved articles for additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing inhaled corticosteroids to placebo, started between seven days' postnatal age (PNA) and 36 weeks' PMA, in infants at risk of BPD. We excluded trials investigating systemic corticosteroids versus inhaled corticosteroids.\nData collection and analysis\nWe collected data on participant characteristics, trial methodology, and inhalation regimens. The primary outcomes were mortality, BPD, or both at 36 weeks' PMA. Secondary outcomes included short-term respiratory outcomes (mortality or BPD at 28 days' PNA, failure to extubate, total days of mechanical ventilation and oxygen use, and need for systemic corticosteroids) and adverse effects. We contacted the trial authors to verify the validity of extracted data and to request missing data. We analysed all data using Review Manager 5. Where possible, we reported the results of meta-analyses using risk ratios (RRs) and risk differences (RDs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, along with their 95% confidence intervals (CIs). We analysed ventilated and non-ventilated participants separately. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included seven trials involving 218 preterm infants in this review. We identified no new eligible studies in this update. The evidence is very uncertain regarding whether inhaled corticosteroids affects the combined outcome of mortality or BPD at 36 weeks' PMA (RR 1.10, 95% CI 0.74 to 1.63; RD 0.07, 95% CI −0.21 to 0.34; 1 study, 30 infants; very low-certainty) or its separate components: mortality (RR 3.00, 95% CI 0.35 to 25.78; RD 0.07, 95% CI −0.08 to 0.21; 3 studies, 61 infants; very low-certainty) and BPD (RR 1.00, 95% CI 0.59 to 1.70; RD 0.00, 95% CI −0.31 to 0.31; 1 study, 30 infants; very low-certainty) at 36 weeks' PMA. Inhaled corticosteroids may reduce the need for systemic corticosteroids, but the evidence is very uncertain (RR 0.51, 95% CI 0.26 to 1.00; RD −0.22, 95% CI −0.42 to −0.02; number needed to treat for an additional beneficial outcome 5, 95% CI 2 to 115; 4 studies, 74 infants; very low-certainty). There was a paucity of data on short-term and long-term adverse effects. Despite a low risk of bias in the individual studies, we considered the certainty of the evidence for all comparisons discussed above to be very low, because the studies had few participants, there was substantial clinical heterogeneity between studies, and only three studies reported the primary outcome of this review.\nAuthors' conclusions\nBased on the available evidence, we do not know if inhaled corticosteroids initiated from seven days of life in preterm infants at risk of developing BPD reduces mortality or BPD at 36 weeks' PMA. There is a need for larger randomised placebo-controlled trials to establish the benefits and harms of inhaled corticosteroids.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified seven studies that had investigated this therapy in 218 premature infants. We do not know whether inhaled corticosteroids compared with placebo started from seven days of life reduces death or BPD in premature infants who are at risk of BPD. Nor do we know whether this treatment has any unwanted effects. More research is needed to investigate the potential benefits and harms of inhaled corticosteroids in this population."
}
]
|
query-laysum | 4106 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a common, chronic, inflammatory skin condition that is frequently associated with atopic conditions, including asthma. Leukotriene receptor antagonists (LTRAs) have a corticosteroid-sparing role in asthma, but their role in eczema remains controversial. Currently available topical therapies for eczema are often poorly tolerated, and use of systemic agents is restricted by their adverse effect profile. A review of alternative treatments was therefore warranted.\nObjectives\nTo assess the possible benefits and harms of leukotriene receptor antagonists for eczema.\nSearch methods\nWe searched the following databases to September 2017: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database. We also searched five trial registries, and handsearched the bibliographies of all extracted studies for further relevant trials.\nSelection criteria\nRandomised controlled trials of LTRAs alone or in combination with other (topical or systemic) treatments compared with other treatments alone such as topical corticosteroids or placebo for eczema in the acute or chronic (maintenance) phase of eczema in adults and children.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcome measures were change in disease severity, long-term symptom control, and adverse effects of treatment. Secondary outcomes were change in corticosteroid requirement, reduction of pruritis, quality of life, and emollient requirement. We used GRADE to assess the quality of the evidence for each outcome.\nMain results\nOnly five studies (including a total of 202 participants) met the inclusion criteria, all of which assessed oral montelukast; hence, we found no studies assessing other LTRAs. Treatment ranged from four to eight weeks, and outcomes were assessed at the end of treatment; therefore, we could only report short-term measurements (defined as less than three months follow-up from baseline). Montelukast dosing was 10 mg for adults (age 14 years and above) and 5 mg for children (age 6 years to 14 years). One study included children (aged 6 years and above) among their participants, while the remaining studies only included adults (participant age ranged from 16 to 70 years). The participants were diagnosed with moderate-to-severe eczema in four studies and moderate eczema in one study. The study setting was unclear in two studies, multicentre in two studies, and single centre in one study; the studies were conducted in Europe and Bangladesh. Two studies were industry funded. The comparator was placebo in three studies and conventional treatment in two studies. The conventional treatment comparator was a combination of antihistamines and topical corticosteroids (plus oral antibiotics in one study).\nFour of the studies did not adequately describe their randomisation or allocation concealment method and were considered as at unclear risk of selection bias. Only one study was at low risk of performance and detection bias. However, we judged all studies to be at low risk of attrition and reporting bias.\nWe found no evidence of a difference in disease severity of moderate-to-severe eczema after short-term use of montelukast (10 mg) when compared with placebo. The outcome was assessed using the modified EASI (Eczema Area and Severity Index) score and SASSAD (Six Area, Six Sign Atopic Dermatitis) severity score (standardised mean difference 0.29, with a positive score showing montelukast is favoured, 95% confidence interval (CI) -0.23 to 0.81; 3 studies; n = 131; low-quality evidence).\nWhen short-term montelukast (10 mg) treatment was compared with conventional treatment in one study, the mean improvement in severity of moderate-to-severe eczema was greater in the intervention group (measured using SCORAD (SCORing of Atopic Dermatitis) severity index) (mean difference 10.57, 95% CI 4.58 to 16.56; n = 31); however, another study of 32 participants found no significant difference between groups using the same measure (mean improvement was 25.2 points with montelukast versus 23.9 points with conventional treatment; no further numerical data provided). We judged the quality of the evidence as very low for this outcome, meaning the results are uncertain.\nAll studies reported their adverse event rate during treatment. Four studies (136 participants) reported no adverse events. In one study of 58 participants with moderate eczema who received montelukast 10 mg (compared with placebo), there was one case of septicaemia and one case of dizziness reported in the intervention group, both resulting in study withdrawal, although whether these effects were related to the medication is unclear. Mild side effects (e.g. headache and mild gastrointestinal disturbances) were also noted, but these were fairly evenly distributed between the montelukast and placebo groups. The quality of evidence for this outcome was low.\nNo studies specifically evaluated emollient requirement or quality of life. One study that administered treatment for eight weeks specifically evaluated pruritus improvement at the end treatment and topical corticosteroid use during treatment. We found no evidence of a difference between montelukast (10 mg) and placebo for both outcomes (low-quality evidence, n = 58). No other study assessed these outcomes.\nAuthors' conclusions\nThe findings of this review are limited to montelukast. There was a lack of evidence addressing the review question, and the quality of the available evidence for most of the measured outcomes was low. Some primary and secondary outcomes were not addressed at all, including long-term control.\nWe found no evidence of a difference between montelukast (10 mg) and placebo on disease severity, pruritus improvement, and topical corticosteroid use. Very low-quality evidence means we are uncertain of the effect of montelukast (10 mg) compared with conventional treatment on disease severity. Participants in only one study reported adverse events, which were mainly mild (low-quality evidence).\nThere is no evidence that LTRA is an effective treatment for eczema. Serious limitations were that all studies focused on montelukast and only included people with moderate-to-severe eczema, who were mainly adults; and that each outcome was evaluated with a small sample size, if at all.\nFurther large randomised controlled trials, with a longer treatment duration, of adults and children who have eczema of all severities may help to evaluate the effect of all types of LTRA, especially on eczema maintenance.\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 evidence was low for all but one key result, that is montelukast’s effect on ‘change (improvement) in disease severity’ when compared with conventional treatment, the evidence for which was considered to be very low quality. Overall, very few studies addressed our review question.\nMany outcomes were not assessed, including long-term control, and those that were assessed had relatively few participants, which were mainly adults. The studies focused solely on moderate-severe eczema, and there were concerns with the participants or investigators knowing which treatment was received."
}
]
|
query-laysum | 4107 | [
{
"role": "user",
"content": "Abstract: Background\nEditor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. Further information is available at www.vioxx.com.\nOsteoarthritis is a chronic disease of the joints, characterised by joint pain, stiffness and loss of physical function. Its onset is age-related and occurs usually between the ages of 50 and 60. It is the commonest cause of disability in those aged over 65, with OA of the knee and/or hip affecting over 20 per cent of the elderly population.\nObjectives\nTo establish the efficacy and safety of rofecoxib in the management of OA by systematic review of available evidence.\nSearch methods\nWe searched the following databases up to August 2004: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment Database. The bibliographies of retrieved papers and content experts were consulted for additional references.\nSelection criteria\nAll eligible randomised controlled trials (RCTs) were included. No unpublished RCTs were included in this edition of the review.\nData collection and analysis\nData were abstracted independently by two reviewers. A validated checklist was used to score the quality of the RCTs. Comparable trials were pooled using fixed effects model.\nMain results\nTwenty-six RCTs were included. The comparators were placebo, diclofenac, ibuprofen, naproxen, nimesulide, nabumetone, paracetamol, celecoxib and Arthrotec. The evidence reviewed indicated that rofecoxib was more effective than placebo (patient global response RR 1.75 95% CI: 1.35, 2.26) but was associated with more adverse events (RR 1.32 95% CI 1.11, 1.56). There were no consistent differences in efficacy between rofecoxib and any of the active comparators at equivalent doses. Endoscopic studies indicated that compared to ibuprofen 800mg three times a day, rofecoxib caused fewer erosions and gastric ulcers at doses of 25mg and 50mg; the difference in duodenal ulcers was evident only at a dose of 25mg. Rofecoxib 50mg also caused more endoscopically observed ulcers greater than rofecoxib 25mg (RR 2.48 CI: 1.21, 5.11). Very few of the trials reported overall rates of GI adverse events although rofecoxib was found to cause fewer GI events than naproxen. Only one of the nine trials comparing rofecoxib to celecoxib reported on the overall rates of GI events and this was a comparison of the higher recommended dose of rofecoxib with the lower recommended dose of celecoxib. Similarly, the three trials in older hypertensive patients that examined the cardiovascular safety of rofecoxib and celecoxib used non-comparable doses; the results of these studies indicated that rofecoxib caused more patients to have oedema and a clinically significant increase in systolic blood pressure. This difference between rofecoxib and celecoxib was not evident in studies conducted in more general populations.\nAuthors' conclusions\nRofecoxib was voluntarily withdrawn from global markets in October 2004 therefore there are no implications for practice concerning its use. There remains a number of questions over both the benefits and risks associated with Cox II selective agents and further work is ongoing.\n\nGiven the provided abstract, please respond to the following query: \"What did studies testing rofecoxib in OA show?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Studies showed people taking rofecoxib improved more than people taking a sugar pill.\nThree studies showed that \n• 29 out of 100 people felt better overall with a sugar pill \n• 53 out of 100 people felt better overall with rofecoxib at 12.5 mg per day.\nStudies also showed that improvements were about the same whether people took rofecoxib or a different NSAID."
}
]
|
query-laysum | 4108 | [
{
"role": "user",
"content": "Abstract: Background\nAccumulating evidence suggests an association between prenatal exposure to antiepileptic drugs (AEDs) and increased risk of both physical anomalies and neurodevelopmental impairment. Neurodevelopmental impairment is characterised by either a specific deficit or a constellation of deficits across cognitive, motor and social skills and can be transient or continuous into adulthood. It is of paramount importance that these potential risks are identified, minimised and communicated clearly to women with epilepsy.\nObjectives\nTo assess the effects of prenatal exposure to commonly prescribed AEDs on neurodevelopmental outcomes in the child and to assess the methodological quality of the evidence.\nSearch methods\nWe searched the Cochrane Epilepsy Group Specialized Register (May 2014), Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2014, Issue 4), MEDLINE (via Ovid) (1946 to May 2014), EMBASE (May 2014), Pharmline (May 2014) and Reprotox (May 2014). No language restrictions were imposed. Conference abstracts from the last five years were reviewed along with reference lists from the included studies.\nSelection criteria\nProspective cohort controlled studies, cohort studies set within pregnancy registers and randomised controlled trials were selected for inclusion. Participants were women with epilepsy taking AED treatment; the two control groups were women without epilepsy and women with epilepsy who were not taking AEDs during pregnancy.\nData collection and analysis\nThree authors (RB, JW and JG) independently selected studies for inclusion. Data extraction and risk of bias assessments were completed by five authors (RB, JW, AS, NA, AJM). The primary outcome was global cognitive functioning. Secondary outcomes included deficits in specific cognitive domains or prevalence of neurodevelopmental disorders. Due to substantial variation in study design and outcome reporting only limited data synthesis was possible.\nMain results\nTwenty-two prospective cohort studies were included and six registry based studies. Study quality varied. More recent studies tended to be larger and to report individual AED outcomes from blinded assessments, which indicate improved methodological quality.The developmental quotient (DQ) was lower in children exposed to carbamazepine (CBZ) (n = 50) than in children born to women without epilepsy (n = 79); mean difference (MD) of -5.58 (95% confidence interval (CI) -10.83 to -0.34, P = 0.04). The DQ of children exposed to CBZ (n = 163) was also lower compared to children of women with untreated epilepsy (n = 58) (MD -7.22, 95% CI -12.76 to - 1.67, P = 0.01). Further analysis using a random-effects model indicated that these results were due to variability within the studies and that there was no significant association with CBZ. The intelligence quotient (IQ) of older children exposed to CBZ (n = 150) was not lower than that of children born to women without epilepsy (n = 552) (MD -0.03, 95% CI -3.08 to 3.01, P = 0.98). Similarly, children exposed to CBZ (n = 163) were not poorer in terms of IQ in comparison to the children of women with untreated epilepsy (n = 87) (MD 1.84, 95% CI -2.13 to 5.80, P = 0.36). The DQ in children exposed to sodium valproate (VPA) (n = 123) was lower than the DQ in children of women with untreated epilepsy (n = 58) (MD -8.72, 95% -14.31 to -3.14, P = 0.002). The IQ of children exposed to VPA (n = 76) was lower than for children born to women without epilepsy (n = 552) (MD -8.94, 95% CI -11.96 to -5.92, P < 0.00001). Children exposed to VPA (n = 89) also had lower IQ than children born to women with untreated epilepsy (n = 87) (MD -8.17, 95% CI -12.80 to -3.55, P = 0.0005).\nIn terms of drug comparisons, in younger children there was no significant difference in the DQ of children exposed to CBZ (n = 210) versus VPA (n=160) (MD 4.16, 95% CI -0.21 to 8.54, P = 0.06). However, the IQ of children exposed to VPA (n = 112) was significantly lower than for those exposed to CBZ (n = 191) (MD 8.69, 95% CI 5.51 to 11.87, P < 0.00001). The IQ of children exposed to CBZ (n = 78) versus lamotrigine (LTG) (n = 84) was not significantly different (MD -1.62, 95% CI -5.44 to 2.21, P = 0.41). There was no significant difference in the DQ of children exposed to CBZ (n = 172) versus phenytoin (PHT) (n = 87) (MD 3.02, 95% CI -2.41 to 8.46, P = 0.28). The IQ abilities of children exposed to CBZ (n = 75) were not different from the abilities of children exposed to PHT (n = 45) (MD -3.30, 95% CI -7.91 to 1.30, P = 0.16). IQ was significantly lower for children exposed to VPA (n = 74) versus LTG (n = 84) (MD -10.80, 95% CI -14.42 to -7.17, P < 0.00001). DQ was higher in children exposed to PHT (n = 80) versus VPA (n = 108) (MD 7.04, 95% CI 0.44 to 13.65, P = 0.04). Similarly IQ was higher in children exposed to PHT (n = 45) versus VPA (n = 61) (MD 9.25, 95% CI 4.78 to 13.72, P < 0.0001). A dose effect for VPA was reported in six studies, with higher doses (800 to 1000 mg daily or above) associated with a poorer cognitive outcome in the child. We identified no convincing evidence of a dose effect for CBZ, PHT or LTG. Studies not included in the meta-analysis were reported narratively, the majority of which supported the findings of the meta-analyses.\nAuthors' conclusions\nThe most important finding is the reduction in IQ in the VPA exposed group, which are sufficient to affect education and occupational outcomes in later life. However, for some women VPA is the most effective drug at controlling seizures. Informed treatment decisions require detailed counselling about these risks at treatment initiation and at pre-conceptual counselling. We have insufficient data about newer AEDs, some of which are commonly prescribed, and further research is required. Most women with epilepsy should continue their medication during pregnancy as uncontrolled seizures also carries a maternal risk.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of how studies were designed varied. The more recently completed studies tended to have higher quality ratings, which suggests more reliable evidence."
}
]
|
query-laysum | 4109 | [
{
"role": "user",
"content": "Abstract: Background\nIn healthcare settings, health care workers (HCWs) are at risk of acquiring infectious diseases through sharps injuries and splash exposures to blood or bodily fluids. Education and training interventions are widely used to protect workers' health and safety and to prevent sharps injuries. In certain countries, they are part of obligatory professional development for HCWs.\nObjectives\nTo assess the effects of education and training interventions compared to no intervention or alternative interventions for preventing sharps injuries and splash exposures in HCWs.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, NHSEED, Science Citation Index Expanded, CINAHL and OSH-update (from all time until February 2016). In addition, we searched the databases of Global Health, AustHealth and Web of Science (from all time until February 2016). The original search strategy was re-run in November 2019, and again in February 2020. In April 2020, the search strategy was updated and run in CINAHL, MEDLINE, Scopus and Web of Science (from 2016 to current).\nSelection criteria\nWe considered randomized controlled trials (RCTs), cluster-randomized trials (cluster-RCTs), controlled clinical trials (CCTs), interrupted time series (ITS) study designs, and controlled before-and-after studies (CBA), that evaluated the effect of education and training interventions on the incidence of sharps injuries and splash exposures compared to no-intervention.\nData collection and analysis\nTwo authors (SC, HL) independently selected studies, and extracted data for the included studies. Studies were analyzed, risk of bias assessed (HL, JL) , and pooled using random-effect meta-analysis, where applicable, according to their design types. As primary outcome we looked for sharps injuries and splash exposures and calculated them as incidence of injuries per 1000 health care workers per year. For the quality of evidence we applied GRADE for the main outcomes.\nMain results\nSeven studies met our inclusion criteria: one cluster-RCT, three CCTs, and three ITS studies. The baseline rates of sharps injuries varied from 43 to 203 injuries per 1000 HCWs per year in studies with hospital registry systems. In questionnaire-based studies, the rates of sharps injuries were higher, from 1800 to 7000 injuries per 1000 HCWs per year. The majority of studies utilised a combination of education and training interventions, including interactive demonstrations, educational presentations, web-based information systems, and marketing tools which we found similar enough to be combined.\nIn the only cluster-RCT (n=796) from a high-income country, the single session educational workshop decreased sharps injuries at 12 months follow-up, but this was not statistically significant either measured as registry-based reporting of injuries (RR 0.46, 95% CI 0.16 to 1.30, low-quality evidence) or as self-reported injuries (RR 0.41, 95% CI 0.14 to 1.21, very low-quality evidence)\nIn three CCTs educational interventions decreased sharps injuries at two months follow-up (RR 0.68, 95% CI 0.48 to 0.95, 330 participants, very low-quality evidence).\nIn the meta-analysis of two ITS studies with a similar injury rate, (N=2104), the injury rate decreased immediately post-intervention by 9.3 injuries per 1000 HCWs per year (95% CI -14.9 to -3.8). There was a small non-significant decrease in trend over time post-intervention of 2.3 injuries per 1000 HCWs per year (95% CI -12.4 to 7.8, low-quality evidence).\nOne ITS study (n=255) had a seven-fold higher injury rate compared to the other two ITS studies and only three data points before and after the intervention. The study reported a change in injury rate of 77 injuries per 1000 HCWs (95% CI -117.2 to -37.1, very low-quality evidence) immediately after the intervention, and a decrease in trend post-intervention of 32.5 injuries per 1000 HCWs per year (95% CI -49.6 to -15.4, very low quality evidence).\nNone of the studies allowed analyses of splash exposures separately from sharps injuries. None of the studies reported rates of blood-borne infections in patients or staff. There was very low-quality evidence of short-term positive changes in process outcomes such as knowledge in sharps injuries and behaviors related to injury prevention.\nAuthors' conclusions\nWe found low- to very low-quality evidence that education and training interventions may cause small decreases in the incidence of sharps injuries two to twelve months after the intervention. There was very low-quality evidence that educational interventions may improve knowledge and behaviors related to sharps injuries in the short term but we are uncertain of this effect. Future studies should focus on developing valid measures of sharps injuries for reliable monitoring. Developing educational interventions in high-risk settings is another priority.\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": "Healthcare workers (HCWs) are at risk of experiencing a sharps injury or being splashed with blood or other bodily fluids whilst delivering care to their patients, which puts them at risk of developing infectious diseases. This review is part of a series investigating interventions for the prevention of such injuries, more specifically, the effectiveness of education and training interventions in reducing the occurrence of these injuries. We comprehensively searched multiple databases to find randomized and non-randomized studies that utilized educational intervention for preventing sharps and splash exposure."
}
]
|
query-laysum | 4110 | [
{
"role": "user",
"content": "Abstract: Background\nThe symptoms of eczema can lead to sleeplessness and fatigue and may have a substantial impact on quality of life. Use of oral H1 antihistamines (H1 AH) as adjuvant therapy alongside topical agents is based on the idea that combining the anti-inflammatory effects of topical treatments with the blocking action of histamine on its receptors in the skin by H1 AH (to reduce the principal symptom of itch) might magnify or intensify the effect of treatment. Also, it would be unethical to compare oral H1 AH alone versus no treatment, as topical treatment is the standard management for this condition.\nObjectives\nTo assess the effects of oral H1 antihistamines as 'add-on' therapy to topical treatment in adults and children with eczema.\nSearch methods\nWe searched the following databases up to May 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database (Global Resource of EczemA Trials; from inception). We searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We also searched the abstracts of four conference proceedings held between 2000 and 2018.\nSelection criteria\nWe sought RCTs assessing oral H1 AH as 'add-on' therapy to topical treatment for people with eczema compared with topical treatment plus placebo or no additional treatment as add-on therapy.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Primary outcome measures were 'Mean change in patient-assessed symptoms of eczema' and 'Proportion of participants reporting adverse effects and serious adverse events'. Secondary outcomes were 'Mean change in physician-assessed clinical signs', 'Mean change in quality of life', and 'Number of eczema flares'.\nMain results\nWe included 25 studies (3285 randomised participants). Seventeen studies included 1344 adults, and eight studies included 1941 children. Most studies failed to report eczema severity at baseline, but they were conducted in secondary care settings, so it is likely that they recruited patients with more severe cases of eczema. Trial duration was between three days and 18 months. Researchers studied 13 different H1 AH treatments. We could not undertake pooling because of the high level of diversity across studies in terms of duration and dose of intervention, concomitant topical therapy, and outcome assessment. Risk of bias was generally unclear, but five studies had high risk of bias in one domain (attrition, selection, or reporting bias). Only one study measured quality of life, but these results were insufficient for statistical analysis.\nAlthough this review assessed 17 comparisons, we summarise here the results of three key comparisons in this review.\nCetirizine versus placebo\nOne study compared cetirizine 0.5 mg/kg/d against placebo over 18 months in 795 children. Study authors did not report patient-assessed symptoms of eczema separately for pruritus. Cetirizine is probably associated with fewer adverse events (mainly mild) (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.46 to 1.01) and the need for slightly less additional H1 AH use as an indication of eczema flare rate (P = 0.035; no further numerical data given). Physician-assessed clinical signs (SCORing Atopic Dermatitis index (SCORAD)) were reduced in both groups, but the difference between groups was reported as non-significant (no P value given). Evidence for this comparison was of moderate quality.\nOne study assessed cetirizine 10 mg/d against placebo over four weeks in 84 adults. Results show no evidence of differences between groups in patient-assessed symptoms of eczema (pruritus measured as part of SCORAD; no numerical data given), numbers of adverse events (RR 1.11, 95% CI 0.50 to 2.45; mainly sedation, other skin-related problems, respiratory symptoms, or headache), or physician-assessed changes in clinical signs, amount of local rescue therapy required, or number of applications as an indicator of eczema flares (no numerical data reported). Evidence for this comparison was of low quality.\nFexofenadine versus placebo\nCompared with placebo, fexofenadine 120 mg/d taken in adults over one week (one study) probably leads to a small reduction in patient-assessed symptoms of pruritus on a scale of 0 to 8 (mean difference (MD) -0.25, 95% CI -0.43 to -0.07; n = 400) and a greater reduction in the ratio of physician-assessed pruritus area to whole body surface area (P = 0.007; no further numerical data given); however, these reductions may not be clinically meaningful. Results suggest probably little or no difference in adverse events (mostly somnolence and headache) (RR 1.05, 95% CI 0.74 to 1.50; n = 411) nor in the amount of 0.1% hydrocortisone butyrate used (co-intervention in both groups) as an indicator of eczema flare, but no numerical data were given. Evidence for this comparison was of moderate quality.\nLoratadine versus placebo\nA study of 28 adults compared loratadine 10 mg/d taken over 4 weeks versus placebo. Researchers found no evidence of differences between groups in patient-assessed pruritus, measured by a 100-point visual analogue scale (MD -2.30, 95% CI -20.27 to 15.67); reduction in physician-assessed clinical signs (SCORAD) (MD -4.10, 95% CI -13.22 to 5.02); or adverse events. Study authors reported only one side effect (folliculitis with placebo) (RR 0.25, 95% CI 0.01 to 5.76). Evidence for this comparison was of low quality. Number of eczema flares was not measured for this comparison.\nAuthors' conclusions\nBased on the main comparisons, we did not find consistent evidence that H1 AH treatments are effective as 'add-on' therapy for eczema when compared to placebo; evidence for this comparison was of low and moderate quality. However, fexofenadine probably leads to a small improvement in patient-assessed pruritus, with probably no significant difference in the amount of treatment used to prevent eczema flares. Cetirizine was no better than placebo in terms of physician-assessed clinical signs nor patient-assessed symptoms, and we found no evidence that loratadine was more beneficial than placebo, although all interventions seem safe.\nThe quality of evidence was limited because of poor study design and imprecise results. Future researchers should clearly define the condition (course and severity) and clearly report their methods, especially participant selection and randomisation; baseline characteristics; and outcomes (based on the Harmonising Outcome Measures in Eczema initiative).\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": "For all outcomes across key comparisons, evidence was of low to moderate certainty. Reasons for lowering the quality of evidence include concerns over how studies were carried out and inclusion of too few participants, leading to less accurate results."
}
]
|
query-laysum | 4111 | [
{
"role": "user",
"content": "Abstract: Background\nFractures of the tibial plateau, which are intra-articular injuries of the knee joint, are often difficult to treat and have a high complication rate, including early-onset osteoarthritis. Surgical fixation is usually used for more complex tibial plateau fractures. Additionally, bone void fillers are often used to address bone defects caused by the injury. Currently there is no consensus on either the best method of fixation or bone void filler.\nObjectives\nTo assess the effects (benefits and harms) of different surgical interventions, and the use of bone void fillers, for treating tibial plateau fractures.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (12 September 2014), the Cochrane Central Register of Controlled Trials (2014 Issue 8), MEDLINE (1946 to September Week 1 2014), EMBASE (1974 to 2014 Week 36), trial registries (4 July 2014), conference proceedings and grey literature (4 July 2014).\nSelection criteria\nWe included randomised and quasi-randomised controlled clinical trials comparing surgical interventions for treating tibial plateau fractures and the different types of filler for filling bone defects.\nData collection and analysis\nTwo review authors independently screened search results, selected studies, extracted data and assessed risk of bias. We calculated risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CIs). Only very limited pooling, using the fixed-effect model, was possible. Our primary outcomes were quality of life measures, patient-reported outcome measures of lower limb function and serious adverse events.\nMain results\nWe included six trials in the review, with a total of 429 adult participants, the majority of whom were male (63%). Three trials evaluated different types of fixation and three analysed different types of bone graft substitutes. All six trials were small and at substantial risk of bias. We judged the quality of most of the available evidence to be very low, meaning that we are very uncertain about these results.\nOne trial compared the use of a circular fixator combined with insertion of percutaneous screws (hybrid fixation) versus standard open reduction and internal fixation (ORIF) in people with open or closed Schatzker types V or VI tibial plateau fractures. Results (66 participants) for quality of life scores using the 36-item Short Form Health Survey (SF-36)), Hospital for Special Surgery (HSS) scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores tended to favour hybrid fixation, but a benefit of ORIF could not be ruled out. Participants in the hybrid fixation group had a lower risk for an unplanned reoperation (351 per 1000 people compared with 450 in the ORIF group; 95% CI 197 fewer to 144 more) and were more likely to have returned to their pre-injury activity level (303 per 1000 people, compared with 121 in the ORIF group; 95% CI 15 fewer to 748 more). Results of the two groups were comparable for the WOMAC pain subscale and stiffness scores, but mean knee range of motion values were higher in the hybrid group.\nAnother trial compared the use of a minimally invasive plate (LISS system) versus double-plating ORIF in 84 people who had open or closed bicondylar tibial plateau fractures. Nearly twice as many participants (22 versus 12) in the ORIF group had a bone graft. Quality of life, pain, knee range of motion and return to pre-injury activity were not reported. The trial provided no evidence of differences in HSS knee scores, complications or reoperation entailing implant removal or revision fixation. A quasi-randomised trial comparing arthroscopically-assisted percutaneous reduction and internal fixation versus standard ORIF reported results at 14 months in 58 people with closed Schatzker types II or III tibial plateau fracture. Quality of life, pain and return to pre-injury activity were not reported. There was very low quality evidence of higher HSS knee scores and higher knee range of motion values in the arthroscopically assisted group. No reoperations were reported.\nThree trials compared different types of bone substitute versus autologous bone graft (autograft) for managing bone defects. Quality of life, pain and return to pre-injury activity were not reported. Only one trial (25 participants) reported on lower limb function, finding good or excellent results in both groups for walking, climbing stairs, squatting and jumping at 12 months. The incidences of individual complications were similar between groups in all three trials. One trial found no cases of inflammatory response in the 20 participants receiving bone substitute, and two found no complications associated with the donor site in the autograft group (58 participants). However, all 38 participants in the autologous iliac bone graft group of one trial reported prolonged pain from the harvest site. Two trials reported similar range of motion results in the two groups, whereas the third trial favoured the bone substitute group.\nAuthors' conclusions\nCurrently, there is insufficient evidence to ascertain the best method of fixation or the best method of addressing bone defects during surgery. However, the evidence does not contradict approaches aiming to limit soft-tissue dissection and damage or to avoid autograft donor site complications through using bone substitutes. Further well-designed, larger randomised trials are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Currently, there is insufficient evidence to ascertain the best surgical methods of fixation and bone defect treatment for tibial plateau fractures in adults. Well-conducted trials are still needed to inform clinical decision-making."
}
]
|
query-laysum | 4112 | [
{
"role": "user",
"content": "Abstract: Background\nInflammatory bowel disease (IBD), comprised of Crohn's disease (CD) and ulcerative colitis (UC), is characterized by chronic mucosal inflammation, frequent hospitalizations, adverse health economics, and compromised quality of life. Diet has been hypothesised to influence IBD activity.\nObjectives\nTo evaluate the efficacy and safety of dietary interventions on IBD outcomes.\nSearch methods\nWe searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, Web of Science, Clinicaltrials.gov and the WHO ICTRP from inception to 31 January 2019. We also scanned reference lists of included studies, relevant reviews and guidelines.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared the effects of dietary manipulations to other diets in participants with IBD. Studies that exclusively focused on enteral nutrition, oral nutrient supplementation, medical foods, probiotics, and parenteral nutrition were excluded.\nData collection and analysis\nTwo review authors independently performed study selection, extracted data and assessed bias using the risk of bias tool. We conducted meta-analyses where possible using a random-effects model and calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes. We assessed the certainty of evidence using GRADE.\nMain results\nThe review included 18 RCTs with 1878 participants. The studies assessed different dietary interventions for active CD (six studies), inactive CD (seven studies), active UC (one study) and inactive UC (four studies). Dietary interventions involved either the consumption of low amounts or complete exclusion of one or more food groups known to trigger IBD symptoms. There was limited scope for data pooling as the interventions and control diets were diverse. The studies were mostly inadequately powered. Fourteen studies were rated as high risk of bias. The other studies were rated as unclear risk of bias.\nThe effect of high fiber, low refined carbohydrates, low microparticle diet, low calcium diet, symptoms-guided diet and highly restricted organic diet on clinical remission in active CD is uncertain. At 4 weeks, remission was induced in: 100% (4/4) of participants in the low refined carbohydrates diet group compared to 0% (0/3) of participants in the control group (RR 7.20, 95% CI 0.53 to 97.83; 7 participants; 1 study; very low certainty evidence). At 16 weeks, 44% (23/52) of participants in the low microparticle diet achieved clinical remission compared to 25% (13/51) of control-group participants (RR 3.13, 95% CI 0.22 to 43.84; 103 participants; 2 studies; I² = 73%; very low certainty evidence). Fifty per cent (16/32) of participants in the symptoms-guided diet group achieved clinical remission compared to 0% (0/19) of control group participants (RR 20.00, 95% CI 1.27 to 315.40; 51 participants ; 1 study; very low certainty evidence) (follow-up unclear). At 24 weeks, 50% (4/8) of participants in the highly restricted organic diet achieved clinical remission compared to 50% (5/10) of participants in the control group (RR 1.00, 95% CI 0.39 to 2.53; 18 participants; 1 study; very low certainty evidence). At 16 weeks, 37% (16/43) participants following a low calcium diet achieved clinical remission compared to 30% (12/40) in the control group (RR 1.24, 95% CI 0.67 to 2.29; 83 participants; 1 study; very low certainty evidence).\nThe effect of low refined carbohydrate diets, symptoms-guided diets and low red processed meat diets on relapse in inactive CD is uncertain. At 12 to 24 months, 67% (176/264) of participants in low refined carbohydrate diet relapsed compared to 64% (193/303) in the control group (RR 1.04, 95% CI 0.87 to 1.25; 567 participants; 3 studies; I² = 35%; low certainty evidence). At 6 to 24 months, 48% (24/50) of participants in the symptoms-guided diet group relapsed compared to 83% (40/48) participants in the control diet (RR 0.53, 95% CI 0.28 to 1.01; 98 participants ; 2 studies; I² = 54%; low certainty evidence). At 48 weeks, 66% (63/96) of participants in the low red and processed meat diet group relapsed compared to 63% (75/118) of the control group (RR 1.03, 95% CI 0.85 to 1.26; 214 participants; 1 study; low certainty evidence). At 12 months, 0% (0/16) of participants on an exclusion diet comprised of low disaccharides / grains / saturated fats / red and processed meat experienced clinical relapse compared to 26% (10/38) of participants on a control group (RR 0.11, 95% CI 0.01 to 1.76; 54 participants; 1 study; very low certainty evidence).\nThe effect of a symptoms-guided diet on clinical remission in active UC is uncertain. At six weeks, 36% (4/11) of symptoms-guided diet participants achieved remission compared to 0% (0/10) of usual diet participants (RR 8.25, 95% CI 0.50 to 136.33; 21 participants; 1 study; very low certainty evidence).\nThe effect of the Alberta-based anti-inflammatory diet, the Carrageenan-free diet or milk-free diet on relapse rates in inactive UC is uncertain. At 6 months, 36% (5/14) of participants in the Alberta-based anti-inflammatory diet group relapsed compared to 29% (4/14) of participants in the control group (RR 1.25, 95% CI 0.42 to 3.70; 28 participants; 1 study; very low certainty evidence). Thirty per cent (3/10) of participants following the carrageenan-free diet for 12 months relapsed compared to 60% (3/5) of the participants in the control group (RR 0.50, 95% CI 0.15 to 1.64; 15 participants; 1 study; very low certainty evidence). At 12 months, 59% (23/39) of milk free diet participants relapsed compared to 68% (26/38) of control diet participants (RR 0.83, 95% CI 0.60 to 1.15; 77 participants; 2 studies; I² = 0%; low certainty evidence).\nNone of the included studies reported on diet-related adverse events.\nAuthors' conclusions\nThe effects of dietary interventions on CD and UC are uncertain. Thus no firm conclusions regarding the benefits and harms of dietary interventions in CD and UC can be drawn. There is need for consensus on the composition of dietary interventions in IBD and more RCTs are required to evaluate these interventions. Currently, there are at least five ongoing studies (estimated enrollment of 498 participants). This review will be updated when the results of these studies are available.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 18 studies including 1878 participants. The diets studied included reduction or exclusion of foods believed to provoke IBD symptoms. These diets were compared with 'usual' diets. The studies assessed dietary interventions for active CD (six studies), inactive CD (seven studies), active UC (one study) and inactive UC (four studies). One study recruited children, while the rest included adults. The studies were poorly designed and had few participants. As a result the overall quality of the evidence was very low.\nThe effect of high fiber, low refined carbohydrates, low microparticle, low calcium, symptoms-guided diet and highly restricted organic diet on clinical remission in active CD is uncertain. In one study, remission was achieved at 4 weeks in 100% (4/4) of low refined carbohydrates participants compared to 0% (0/3) of usual diet participants. In a pooled analysis of two studies, 44% (23/52) of low microparticle participants achieved remission at 16 weeks compared to 25% (13/51) of usual diet participants. One study found that 50% (16/32) of symptoms-guided participants achieved remission compared to 0% (0/19) of usual diet participants. One study found that 50% (4/8) of highly-restricted organic diet participants achieved remission at 24 weeks compared to 50% (5/10) of usual diet participants. One study found that 37% (16/43) of low-calcium participants achieved remission at 16 weeks compared to 30% (12/40) of usual diet participants.\nThe effect of low refined carbohydrate, symptoms-guided and low red processed meat diets on relapse in inactive CD is uncertain. In a pooled analysis of three studies, 67% (176/264) of low refined carbohydrate participants relapsed at 12 to 24 months compared to 64% (193/303) of usual diet participants. In a pooled analysis of two studies, 48% (24/50) of symptoms-guided participants relapsed at 6 to 24 months compared to 83% (40/48) of usual diet participants. One study found that 66% (63/96) of low red and processed meat participants relapsed at 48 weeks compared to 63% (75/118) of usual diet participants. One study showed that 0% (0/16) of exclusion diet participants (i.e. low disaccharides, grains, saturated fats, red and processed meat) relapsed at 12 months compared to 26% (10/38) of usual diet participants.\nThe effect of a symptoms-guided diet on clinical remission in active UC is uncertain. In one study, 36% (4/11) of symptoms-guided participants achieved remission at six weeks compared to 0% (0/10) in the usual diet group.\nThe effect of the Alberta-based anti-inflammatory diet, the Carrageenan-free diet and the milk-free diet on relapse in inactive UC is uncertain. In one study, 36% (5/14) of Alberta-based diet participants relapsed at 6 months compared to 29% (4/14) of usual diet participants. In one study, 30% (3/10) of carrageenan-free participants relapsed at 12 months compared to 60% (3/5) of usual diet participants. At 12 months, 59% (23/39) of milk-free diet participants relapsed compared to 68% (26/38) in the usual diet group.\nNone of the included studies reported on diet-related side effects."
}
]
|
query-laysum | 4113 | [
{
"role": "user",
"content": "Abstract: Background\nPlasmodium vivax malaria has a persistent liver stage that causes relapse of the disease and continued P vivax transmission. Primaquine (PQ) is used to clear the liver stage of the parasite, but treatment is required for 14 days. Primaquine also causes haemolysis in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Tafenoquine (TQ) is a new alternative to PQ with a longer half-life and can be used as a single-dose treatment.\nObjectives\nTo assess the effects of tafenoquine 300 mg (single dose) on preventing P vivax relapse.\nSearch methods\nWe searched the following up to 3 June 2020: the Cochrane Infectious Diseases Group Specialized Register; CENTRAL; MEDLINE; Embase; and three other databases. We also searched the WHO International Clinical Trial Registry Platform and the metaRegister of Controlled Trials for ongoing trials using \"tafenoquine\" and \"malaria\" as search terms up to 3 June 2020.\nSelection criteria\nRandomized controlled trials (RCTs) that gave TQ to prevent relapse in people with P vivax malaria. We planned to include trials irrespective of whether participants had been screened for G6PD enzyme deficiency.\nData collection and analysis\nAll review authors independently extracted data and assessed risk of bias. As true relapse and reinfection are difficult to differentiate in people living in endemic areas, studies report \"recurrences\" of infection as a proxy for relapse. We carried out meta-analysis where appropriate, and gave estimates as risk ratios (RR) with 95% confidence intervals (CI). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nThree individually randomized RCTs met our inclusion criteria, all in endemic areas, and thus reporting recurrence. Trials compared TQ with PQ or placebo, and all participants received chloroquine (CQ) to treat the asexual infection). In all trials, pregnant and G6PD-deficient people were excluded.\nTafenoquine 300 mg single dose versus no treatment for relapse prevention\nTwo trials assessed this comparison. TQ 300 mg single dose reduces P vivax recurrences compared to no antihypnozoite treatment during a six-month follow-up, but there is moderate uncertainty around effect size (RR 0.32, 95% CI 0.12 to 0.88; 2 trials, 504 participants; moderate-certainty evidence).\nIn people with normal G6PD status, there is probably little or no difference in any type of adverse events (2 trials, 504 participants; moderate-certainty evidence). However, we are uncertain if TQ causes more serious adverse events (2 trials, 504 participants; very low-certainty evidence). Both RCTs reported a total of 23 serious adverse events in TQ groups (One RCT reported 21 events) and a majority (15 events) were a drop in haemoglobin level by > 3g/dl (or >30% reduction from baseline).\nTafenoquine 300 mg single dose versus primaquine 15 mg/day for 14 days for relapse prevention\nThree trials assessed this comparison. There is probably little or no difference between TQ and PQ in preventing recurrences (proxy measure for relapse) up to six months of follow-up (RR 1.04, 95% CI 0.8 to 1.34; 3 trials, 747 participants; moderate-certainty evidence).\nIn people with normal G6PD status, there is probably little or no difference in any type of adverse events (3 trials, 747 participants; moderate-certainty evidence). We are uncertain if TQ can cause more serious adverse events compared to PQ (3 trials, 747 participants; very low-certainty evidence). Two trials had higher point estimates against TQ while the other showed the reverse. Most commonly reported serious adverse event in TQ group was a decline in haemoglobin level (19 out of 29 events). Some other serious adverse events, though observed in the TQ group, are unlikely to be caused by it (Hepatitis E infection, limb abscess, pneumonia, menorrhagia).\nAuthors' conclusions\nTQ 300 mg single dose prevents relapses after clinically parasitologically confirmed P vivax malaria compared to no antihypnozoite treatment, and with no difference detected in studies comparing it to PQ to date. However, the inability to differentiate a true relapse from a recurrence in the available studies may affect these estimates. The drug is untested in children and in people with G6PD deficiency. Single-dose treatment is an important practical advantage compared to using PQ for the same purpose without an overall increase in adverse events in non-pregnant, non-G6PD-deficient adults.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to see if tafenoquine could prevent relapses of vivax infections and if this effect is equivalent to that of standard-dose primaquine. Standard-dose primaquine is defined as 15 mg/day for 14 days for adults."
}
]
|
query-laysum | 4114 | [
{
"role": "user",
"content": "Abstract: Background\nMalnutrition is common in patients with chronic kidney disease (CKD) on dialysis. Oral protein-based nutritional supplements are often provided to patients whose oral intake is otherwise insufficient to meet their energy and protein needs. Evidence for the effectiveness of oral protein-based nutritional supplements in this population is limited.\nObjectives\nThe aims of this review were to determine the benefits and harms of using oral protein-based nutritional supplements to improve the nutritional state of patients with CKD requiring dialysis.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 12 December 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) of patients with CKD requiring dialysis that compared oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo.\nData collection and analysis\nTwo authors independently assessed studies for eligibility, risk of bias, and extracted data from individual studies. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference and 95% CI for continuous outcomes.\nMain results\nTwenty-two studies (1278 participants) were included in this review. All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis. The follow-up period ranged from one to 12 months. The majority of studies were at unclear risk of selection, performance, and reporting bias. The detection bias was high for self-reported outcomes.\nOral protein-based nutritional supplements probably lead to a higher mean change in serum albumin compared to the control group (16 studies, 790 participants: MD 0.19 g/dL, 95% CI 0.05 to 0.33; moderate certainty evidence), although there was considerable heterogeneity in the combined analysis (I2 = 84%). The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect). Oral protein-based nutritional supplements also probably leads to a higher mean serum albumin at the end of the intervention (14 studies, 715 participants: MD 0.14 g/dL, 95% CI 0 to 0.27; moderate certainty evidence), however heterogeneity was again high (I2 = 80%). Again the increase was more evident in HD participants (9 studies, 498 participants: MD 0.21 g/dL, 95% CI 0.03 to 0.38; P = 0.02 for overall effect) and malnourished participants (7 studies, 377 participants: MD 0.25 g/dL, 95% CI 0.02 to 0.47; P = 0.03 for overall effect).\nCompared to placebo or no supplement, low certainty evidence showed oral protein-based nutritional supplements may result in a higher serum prealbumin (4 studies, 225 participants: MD 2.81 mg/dL, 95% CI 2.19 to 3.43), and mid-arm muscle circumference (4 studies, 216 participants: MD 1.33 cm, 95% CI 0.24 to 2.43) at the end of the intervention. Compared to placebo or no supplement, oral protein-based nutritional supplements may make little or no difference to weight (8 studies, 365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants: MD -0.04 kg/m2, 95% CI -0.74 to 0.66; moderate certainty evidence) and lean mass (5 studies, 189 participants: MD 1.27 kg, 95% CI -1.61 to 4.51; low certainty evidence). Due to very low quality of evidence, it is uncertain whether oral protein-based nutritional supplements affect triceps skinfold thickness, mid-arm circumference, C-reactive protein, Interleukin 6, serum potassium, or serum phosphate.\nThere may be little or no difference in the risk of developing gastrointestinal intolerance between participants who received oral protein-based nutritional supplements compared with placebo or no supplement (6 studies, 426 participants: RR 2.81, 95% CI 0.58 to 13.65, low certainty evidence). It was not possible to draw conclusions about cost or quality of life, and deaths were not reported as a study outcome in any of the included studies.\nAuthors' conclusions\nOverall, it is likely that oral protein-based nutritional supplements increase both mean change in serum albumin and serum albumin at end of intervention and may improve serum prealbumin and mid-arm muscle circumference. The improvement in serum albumin was more evident in haemodialysis and malnourished participants. However, it remains uncertain whether these results translate to improvement in nutritional status and clinically relevant outcomes such as death. Large well-designed RCTs in this population are required.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with chronic kidney disease requiring dialysis are at risk of developing malnutrition for many reasons and often do not eat enough because their appetite is poor. Oral nutritional supplements are commonly provided to people who do not eat enough to meet their needs. Provision of nutritional supplements to dialysis patients requires careful consideration of potassium, phosphate and fluid limits."
}
]
|
query-laysum | 4115 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile nystagmus syndrome (INS) is a type of eye movement disorder that can negatively impact vision. Currently, INS cannot be cured, but its effects can potentially be treated pharmacologically, optically, or surgically. This review focuses on the surgical interventions for INS.\nDespite the range of surgical interventions available, and currently applied in practice for the management of INS, there is no clear consensus, and no accepted clinical guidelines regarding the relative efficacy and safety of the various treatment options. A better understanding of these surgical options, along with their associated side effects, will assist clinicians in evidence-based decision-making in relation to the management of INS.\nObjectives\nTo assess the efficacy and safety of surgical interventions for INS.\nSearch methods\nWe searched CENTRAL, MEDLINE Ovid, Embase Ovid, ISRCTN registry, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to 3 July 2020, with no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) studying the efficacy and safety of surgical options for treating INS.\nData collection and analysis\nOur prespecified outcome measures were the change from baseline in: binocular best-corrected distance visual acuity; head posture; amplitude, frequency, intensity, and foveation period durations of the nystagmus waveform; visual recognition times; quality of life and self-reported outcome measures; incidence of adverse effects with a probable causal link to treatment; and permanent adverse effects after surgery.\nTwo review authors independently screened titles and abstracts and full-text articles, extracted data from eligible RCTs, and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE approach.\nMain results\nWe only identified one eligible RCT (N = 10 participants), undertaken in India. This trial randomised participants to receive either a large retro-equatorial recession of the horizontal rectus muscle of 9 mm on the medial rectus and 12 mm on the lateral rectus, or a simple tenotomy and resuturing of the four horizontal rectus muscles. We did not identify any RCTs comparing a surgical intervention for INS relative to no treatment.\nIn the single eligible RCT, both eyes of each participant received the same intervention. The participants’ age and gender were not reported, nor was information on whether participants were idiopathic or had sensory disorders. The study only included participants with null in primary position and did not explicitly exclude those with congenital periodic alternating nystagmus. The study did not report funding source(s) or author declaration of interests. The evaluation period was six months.\nWe judged this study at low risk for sequence generation and other sources of bias, but at high risk of bias for performance and detection bias. The risk of bias was unclear for selection bias, attrition bias, and reporting bias.\nThere is very uncertain evidence about the effect of the interventions on visual acuity and change in amplitude, frequency, and intensity of the nystagmus waveform. We were unable to calculate relative effects due to lack of data. None of the participants in either intervention group reported adverse effects at six-month follow-up (very low-certainty evidence). There was no quantitative data reported for quality of life, although the study reported an improvement in quality of life after surgery in both intervention groups (very low-certainty evidence).\nChange in head posture, foveation period durations of the nystagmus waveform, visual recognition times, and permanent adverse effects after surgery were not reported in the included study.\nWe judged the certainty of the evidence, for both the primary and secondary efficacy outcomes, to be very low. Due to a lack of comprehensive reporting of adverse events, there was also very low-certainty of the safety profile of the evaluated surgical interventions in this population. As such, we are very uncertain about the relative efficacy and safety of these interventions for the surgical management of INS.\nAuthors' conclusions\nThis systematic review identified minimal high-quality evidence relating to the efficacy and safety of surgical interventions for INS. The limited availability of evidence must be considered by clinicians when treating INS, particularly given these procedures are irreversible and often performed on children. More high-quality RCTs are needed to better understand the efficacy and safety profile of surgical interventions for INS. This will assist clinicians, people with INS, and their parents or caregivers to make evidence-based treatment decisions.\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 one study, set in India, that involved a total of 10 people with INS who were followed for six months after surgery. The study authors did not report any information about:- the age and gender of the people who took part in it;- or the source of funding for the study.\nThe study compared two different surgical procedures: \n- one procedure in which two horizontal rectus muscles (eye muscles that control side-to-side eye movements) were moved from their original position to a position further back on the eyeball; and\n- another procedure in which four horizontal rectus muscles were detached and reattached, in their original position.\nThe procedures were conducted in both eyes.\nThe study compared the effects of the treatments on:\n- clarity of vision six months after surgery;\n- intensity of eye movement six months after surgery;\n- adverse events six months after surgery; and\n- quality of life.\nThe study did not investigate the effects of treatments on:\n- head posture;\n- the amount of time when the eye is still; or\n- the time it takes to recognise objects.\nWe have very little confidence in the evidence from the study we found, because:\n- it is based on a very small number of people; and\n- the patients and researchers in the study knew which type of surgery each patient received. This knowledge may have influenced the study results.\nWe therefore cannot determine whether the two procedures investigated in the study had different benefits and risks."
}
]
|
query-laysum | 4116 | [
{
"role": "user",
"content": "Abstract: Background\nIntensive Case Management (ICM) is a community-based package of care aiming to provide long-term care for severely mentally ill people who do not require immediate admission. Intensive Case Management evolved from two original community models of care, Assertive Community Treatment (ACT) and Case Management (CM), where ICM emphasises the importance of small caseload (fewer than 20) and high-intensity input.\nObjectives\nTo assess the effects of ICM as a means of caring for severely mentally ill people in the community in comparison with non-ICM (caseload greater than 20) and with standard community care. We did not distinguish between models of ICM. In addition, to assess whether the effect of ICM on hospitalisation (mean number of days per month in hospital) is influenced by the intervention's fidelity to the ACT model and by the rate of hospital use in the setting where the trial was conducted (baseline level of hospital use).\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register (last update search 10 April 2015).\nSelection criteria\nAll relevant randomised clinical trials focusing on people with severe mental illness, aged 18 to 65 years and treated in the community care setting, where ICM is compared to non-ICM or standard care.\nData collection and analysis\nAt least two review authors independently selected trials, assessed quality, and extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses.\nWe performed a random-effects meta-regression analysis to examine the association of the intervention's fidelity to the ACT model and the rate of hospital use in the setting where the trial was conducted with the treatment effect. We assessed overall quality for clinically important outcomes using the GRADE approach and investigated possible risk of bias within included trials.\nMain results\nThe 2016 update included two more studies (n = 196) and more publications with additional data for four already included studies. The updated review therefore includes 7524 participants from 40 randomised controlled trials (RCTs). We found data relevant to two comparisons: ICM versus standard care, and ICM versus non-ICM. The majority of studies had a high risk of selective reporting. No studies provided data for relapse or important improvement in mental state.\n1. ICM versus standard care\nWhen ICM was compared with standard care for the outcome service use, ICM slightly reduced the number of days in hospital per month (n = 3595, 24 RCTs, MD -0.86, 95% CI -1.37 to -0.34,low-quality evidence). Similarly, for the outcome global state, ICM reduced the number of people leaving the trial early (n = 1798, 13 RCTs, RR 0.68, 95% CI 0.58 to 0.79, low-quality evidence). For the outcome adverse events, the evidence showed that ICM may make little or no difference in reducing death by suicide (n = 1456, 9 RCTs, RR 0.68, 95% CI 0.31 to 1.51, low-quality evidence). In addition, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment due to very low-quality evidence (n = 1129, 4 RCTs, RR 0.70, 95% CI 0.49 to 1.0, very low-quality evidence).\n2. ICM versus non-ICM\nWhen ICM was compared with non-ICM for the outcome service use, there was moderate-quality evidence that ICM probably makes little or no difference in the average number of days in hospital per month (n = 2220, 21 RCTs, MD -0.08, 95% CI -0.37 to 0.21, moderate-quality evidence) or in the average number of admissions (n = 678, 1 RCT, MD -0.18, 95% CI -0.41 to 0.05, moderate-quality evidence) compared to non-ICM. Similarly, the results showed that ICM may reduce the number of participants leaving the intervention early (n = 1970, 7 RCTs, RR 0.70, 95% CI 0.52 to 0.95,low-quality evidence) and that ICM may make little or no difference in reducing death by suicide (n = 1152, 3 RCTs, RR 0.88, 95% CI 0.27 to 2.84, low-quality evidence). Finally, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment as compared to non-ICM (n = 73, 1 RCT, RR 1.46, 95% CI 0.45 to 4.74, very low-quality evidence).\n3. Fidelity to ACT\nWithin the meta-regression we found that i.) the more ICM is adherent to the ACT model, the better it is at decreasing time in hospital ('organisation fidelity' variable coefficient -0.36, 95% CI -0.66 to -0.07); and ii.) the higher the baseline hospital use in the population, the better ICM is at decreasing time in hospital ('baseline hospital use' variable coefficient -0.20, 95% CI -0.32 to -0.10). Combining both these variables within the model, 'organisation fidelity' is no longer significant, but the 'baseline hospital use' result still significantly influences time in hospital (regression coefficient -0.18, 95% CI -0.29 to -0.07, P = 0.0027).\nAuthors' conclusions\nBased on very low- to moderate-quality evidence, ICM is effective in ameliorating many outcomes relevant to people with severe mental illness. Compared to standard care, ICM may reduce hospitalisation and increase retention in care. It also globally improved social functioning, although ICM's effect on mental state and quality of life remains unclear. Intensive Case Management is at least valuable to people with severe mental illnesses in the subgroup of those with a high level of hospitalisation (about four days per month in past two years). Intensive Case Management models with high fidelity to the original team organisation of ACT model were more effective at reducing time in hospital.\nHowever, it is unclear what overall gain ICM provides on top of a less formal non-ICM approach.\nWe do not think that more trials comparing current ICM with standard care or non-ICM are justified, however we currently know of no review comparing non-ICM with standard care, and this should be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We carried out electronic searches for randomised controlled trials comparing ICM with non-ICM or standard care in 2009, 2012, and 2015."
}
]
|
query-laysum | 4117 | [
{
"role": "user",
"content": "Abstract: Background\nPrevention of cognitive impairment and dementia is an important public health goal. Epidemiological evidence shows a relationship between cognitive impairment and Type 2 diabetes mellitus. The risk of dementia increases with duration of disease. This updated systematic review investigated the effect on cognitive function of the type of treatment and level of metabolic control in people with Type 2 diabetes.\nObjectives\nTo assess the effects of different strategies for managing Type 2 diabetes mellitus on cognitive function and the incidence of dementia.\nSearch methods\nWe searched ALOIS (the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG)), the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL and LILACS on 15 October 2016. ALOIS contains records from all major health care databases, (CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS), as well as from many trials' registers and grey literature sources.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared two or more different treatments for Type 2 diabetes mellitus and in which cognitive function was measured at baseline and after treatment.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of the included RCTs. We pooled data for comparable trials and estimated the effects of treatment by using risk ratios (RRs) and mean differences (MDs), according to the nature of the outcome. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe identified seven eligible studies but only four provided data we could include in efficacy analyses. Two of these studies compared intensive versus standard glycaemic control and two compared different pharmacological treatments. All studies were at unclear risk of bias in at least two domains and one large study was at high risk of performance and detection bias.\n(a) Two studies with 13,934 participants at high cardiovascular risk provided efficacy data on intensive versus standard glycaemic control. A third study with 1791 participants provided additional data on hypoglycaemic episodes and mortality. There is probably no difference between treatment groups in the number of participants who decline by at least 3 points on the Mini–Mental State Examination (MMSE) over five years (RR 0.98, 95% CI 0.88 to 1.08; 1 study; n = 11,140; moderate-quality evidence); and there may also be little or no difference in the incidence of dementia (RR 1.27, 95% CI 0.87 to 1.85; 1 study; n = 11,140; low-quality evidence). From another study, there was probably little or no difference in MMSE score after 40 months (MD −0.01, 95% CI −0.18 to 0.16; 1 study; n = 2794; moderate quality evidence). Participants exposed to the intensive glycaemic control strategy probably experience more episodes of severe hypoglycaemia than those who have standard treatment (RR 2.18, 95% CI 1.52 to 3.14; 2 studies; n = 12,827; moderate-quality evidence). The evidence from these trials suggests that the intensity of glycaemic control may have little or no effect on all-cause mortality (RR 0.99, 95% CI 0.87 to 1.13; 3 studies; n = 15,888; low-quality evidence).\n(b) One study with 156 participants compared glibenclamide (glyburide) with repaglinide. There may be a small advantage of glibenclamide on global cognitive function measured with the MMSE after 12 months (MD −0.90, 95% CI −1.68 to −0.12; low-quality evidence). No data were reported on the incidence of dementia, hypoglycaemic events or all-cause mortality.\n(c) One study with 145 participants compared rosiglitazone plus metformin to glibenclamide (glyburide) plus metformin over 24 weeks. It reported only on cognitive subdomains and not on global cognitive function, incidence of MCI or dementia, hypoglycaemic events or all causes of mortality.\nAuthors' conclusions\nWe found no good evidence that any specific treatment or treatment strategy for Type 2 diabetes can prevent or delay cognitive impairment. The best available evidence related to the comparison of intensive with standard glycaemic control strategies. Here there was moderate-quality evidence that the strategies do not differ in their effect on global cognitive functioning over 40 to 60 months.\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": "Dementia is a global healthcare concern. Type 2 diabetes mellitus — a form of diabetes which becomes commoner with older age — increases the risk of developing dementia. Type 1 diabetes, which typically begins earlier in life, is always treated with insulin; but there are a variety of different ways of treating Type 2 diabetes, including lifestyle changes and different medications. We wanted to find out if some ways of treating Type 2 diabetes were better than others in terms of preventing either dementia or less serious decline in cognition (memory and other thinking skills)."
}
]
|
query-laysum | 4118 | [
{
"role": "user",
"content": "Abstract: Background\nBiologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics.\nObjectives\nTo compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (placebo or methotrexate (MTX)/other DMARDs) in people with RA, previously unsuccessfully treated with biologics.\nMethods\nOn 22 June 2015 we searched for randomized controlled trials (RCTs) in CENTRAL, MEDLINE, and Embase; and trials registries (WHO trials register, Clinicaltrials.gov). We carried out article selection, data extraction, and risk of bias and GRADE assessments in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparison (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We have also presented results in absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB). Outcomes measured included four benefits (ACR50, function measured by Health Assessment Questionnaire (HAQ) score, remission defined as DAS < 1.6 or DAS28 < 2.6, slowing of radiographic progression) and three harms (withdrawals due to adverse events, serious adverse events, and cancer).\nMain results\nThis update includes nine new RCTs for a total of 12 RCTs that included 3364 participants. The comparator was placebo only in three RCTs (548 participants), MTX or other traditional DMARD in six RCTs (2468 participants), and another biologic in three RCTs (348 participants). Data were available for four tumor necrosis factor (TNF)-biologics: (certolizumab pegol (1 study; 37 participants), etanercept (3 studies; 348 participants), golimumab (1 study; 461 participants), infliximab (1 study; 27 participants)), three non-TNF biologics (abatacept (3 studies; 632 participants), rituximab (2 studies; 1019 participants), and tocilizumab (2 studies; 589 participants)); there was only one study for tofacitinib (399 participants). The majority of the trials (10/12) lasted less than 12 months.\nWe judged 33% of the studies at low risk of bias for allocation sequence generation, allocation concealment and blinding, 25% had low risk of bias for attrition, 92% were at unclear risk for selective reporting; and 92% had low risk of bias for major baseline imbalance. We downgraded the quality of the evidence for most outcomes to moderate or low due to study limitations, heterogeneity, or rarity of direct comparator trials.\nBiologic monotherapy versus placebo\nCompared to placebo, biologics were associated with clinically meaningful and statistically significant improvement in RA as demonstrated by higher ACR50 and RA remission rates. RR was 4.10 for ACR50 (95% CI 1.97 to 8.55; moderate-quality evidence); absolute benefit RD 14% (95% CI 6% to 21%); and NNTB = 8 (95% CI 4 to 23). RR for RA remission was 13.51 (95% CI 1.85 to 98.45, one study available; moderate-quality evidence); absolute benefit RD 9% (95% CI 5% to 13%); and NNTB = 11 (95% CI 3 to 136). Results for withdrawals due to adverse events and serious adverse events did not show any statistically significant or clinically meaningful differences. There were no studies available for analysis for function measured by HAQ, radiographic progression, or cancer outcomes. There were not enough data for any of the outcomes to look at subgroups.\nBiologic + MTX versus active comparator (MTX/other traditional DMARDs)\nCompared to MTX/other traditional DMARDs, biologic + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50, function measured by HAQ, and RA remission rates in direct comparisons. RR for ACR50 was 4.07 (95% CI 2.76 to 5.99; high-quality evidence); absolute benefit RD 16% (10% to 21%); NNTB = 7 (95% CI 5 to 11). HAQ scores showed an improvement with a mean difference (MD) of 0.29 (95% CI 0.21 to 0.36; high-quality evidence); absolute benefit RD 9.7% improvement (95% CI 7% to 12%); and NNTB = 5 (95% CI 4 to 7). Remission rates showed an improved RR of 20.73 (95% CI 4.13 to 104.16; moderate-quality evidence); absolute benefit RD 10% (95% CI 8% to 13%); and NNTB = 17 (95% CI 4 to 96), among the biologic + MTX group compared to MTX/other DMARDs. There were no studies for radiographic progression. Results were not clinically meaningful or statistically significantly different for withdrawals due to adverse events or serious adverse events, and were inconclusive for cancer.\nTofacitinib monotherapy versus placebo\nThere were no published data.\nTofacitinib + MTX versus active comparator (MTX)\nIn one study, compared to MTX, tofacitinib + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50 (RR 3.24; 95% CI 1.78 to 5.89; absolute benefit RD 19% (95% CI 12% to 26%); NNTB = 6 (95% CI 3 to 14); moderate-quality evidence), and function measured by HAQ, MD 0.27 improvement (95% CI 0.14 to 0.39); absolute benefit RD 9% (95% CI 4.7% to 13%), NNTB = 5 (95% CI 4 to 10); high-quality evidence). RA remission rates were not statistically significantly different but the observed difference may be clinically meaningful (RR 15.44 (95% CI 0.93 to 256.1; high-quality evidence); absolute benefit RD 6% (95% CI 3% to 9%); NNTB could not be calculated. There were no studies for radiographic progression. There were no statistically significant or clinically meaningful differences for withdrawals due to adverse events and serious adverse events, and results were inconclusive for cancer.\nAuthors' conclusions\nBiologic (with or without MTX) or tofacitinib (with MTX) use was associated with clinically meaningful and statistically significant benefits (ACR50, HAQ, remission) compared to placebo or an active comparator (MTX/other traditional DMARDs) among people with RA previously unsuccessfully treated with biologics.\nNo studies examined radiographic progression. Results were not clinically meaningful or statistically significant for withdrawals due to adverse events and serious adverse events, and were inconclusive for cancer.\n\nGiven the provided abstract, please respond to the following query: \"Remission (DAS < 1.6 or DAS28 < 2.6)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
]
|
query-laysum | 4119 | [
{
"role": "user",
"content": "Abstract: Background\nBuruli ulcer is a necrotizing cutaneous infection caused by infection with Mycobacterium ulcerans bacteria that occurs mainly in tropical and subtropical regions. The infection progresses from nodules under the skin to deep ulcers, often on the upper and lower limbs or on the face. If left undiagnosed and untreated, it can lead to lifelong disfigurement and disabilities. It is often treated with drugs and surgery.\nObjectives\nTo summarize the evidence of drug treatments for treating Buruli ulcer.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE (PubMed); Embase (Ovid); and LILACS (Latin American and Caribbean Health Sciences Literature; BIREME). We also searched the US National Institutes of Health Ongoing Trials Register (clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en/). All searches were run up to 19 December 2017. We also checked the reference lists of articles identified by the literature search, and contacted leading researchers in this topic area to identify any unpublished data.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared antibiotic therapy to placebo or alternative therapy such as surgery, or that compared different antibiotic regimens. We also included prospective observational studies that evaluated different antibiotic regimens with or without surgery.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, extracted the data, and assessed methodological quality. We calculated the risk ratio (RR) for dichotomous data with 95% confidence intervals (CI). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included a total of 18 studies: five RCTs involving a total of 319 participants, ranging from 12 participants to 151 participants, and 13 prospective observational studies, with 1665 participants. Studies evaluated various drugs usually in addition to surgery, and were carried out across eight countries in areas with high Buruli ulcer endemicity in West Africa and Australia. Only one RCT reported adequate methods to minimize bias. Regarding monotherapy, one RCT and one observational study evaluated clofazimine, and one RCT evaluated sulfamethoxazole/trimethoprim. All three studies had small sample sizes, and no treatment effect was demonstrated. The remaining studies examined combination therapy.\nRifampicin combined with streptomycin\nWe found one RCT and six observational studies which evaluated rifampicin combined with streptomycin for different lengths of treatment (2, 4, 8, or 12 weeks) (941 participants). The RCT did not demonstrate a difference between the drugs added to surgery compared with surgery alone for recurrence at 12 months, but was underpowered (RR 0.12, 95% CI 0.01 to 2.51; 21 participants; very low-certainty evidence).\nAn additional five single-arm observational studies with 828 participants using this regimen for eight weeks with surgery (given to either all participants or to a select group) reported healing rates ranging from 84.5% to 100%, assessed between six weeks and one year. Four observational studies reported healing rates for participants who received the regimen alone without surgery, reporting healing rates ranging from 48% to 95% assessed between eight weeks and one year.\nRifampicin combined with clarithromycin\nTwo observational studies administered combined rifampicin and clarithromycin. One study evaluated the regimen alone (no surgery) for eight weeks and reported a healing rate of 50% at 12 months (30 participants). Another study evaluated the regimen administered for various durations (as determined by the clinicians, durations unspecified) with surgery and reported a healing rate of 100% at 12 months (21 participants).\nRifampicin with streptomycin initially, changing to rifampicin with clarithromycin in consolidation phase\nOne RCT evaluated this regimen (four weeks in each phase) against continuing with rifampicin and streptomycin in the consolidation phase (total eight weeks). All included participants had small lesions, and healing rates were above 90% in both groups without surgery (healing rate at 12 months RR 0.94, 95% CI 0.87 to 1.03; 151 participants; low-certainty evidence). One single-arm observational study evaluating the substitution of streptomycin with clarithromycin in the consolidation phase (6 weeks, total 8 weeks) without surgery given to a select group showed a healing rate of 98% at 12 months (41 participants).\nNovel combination therapy\nTwo large prospective studies in Australia evaluated some novel regimens. One study evaluating rifampicin combined with either ciprofloxacin, clarithromycin, or moxifloxacin without surgery reported a healing rate of 76.5% at 12 months (132 participants). Another study evaluating combinations of two to three drugs from rifampicin, ciprofloxacin, clarithromycin, ethambutol, moxifloxacin, or amikacin with surgery reported a healing rate of 100% (90 participants).\nAdverse effects were reported in only three RCTs (158 participants) and eight prospective observational studies (878 participants), and were consistent with what is already known about the adverse effect profile of these drugs. Paradoxical reactions (clinical deterioration after treatment caused by enhanced immune response to M ulcerans) were evaluated in six prospective observational studies (822 participants), and the incidence of paradoxical reactions ranged from 1.9% to 26%.\nAuthors' conclusions\nWhile the antibiotic combination treatments evaluated appear to be effective, we found insufficient evidence showing that any particular drug is more effective than another. How different sizes, lesions, and stages of the disease may contribute to healing and which kind of lesions are in need of surgery are unclear based on the included studies. Guideline development needs to consider these factors in designing practical treatment regimens. Forthcoming trials using clarithromycin with rifampicin and other trials of new regimens that also address these factors will help to identify the best regimens.\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": "Buruli ulcer is a disease caused by mycobacterium (tuberculosis and leprosy are other types of diseases caused by mycobacterium), which results in lumps in the skin and deep ulcers, often on the arms or the face. When diagnosed late, those affected may be left with lifelong disfigurements and disabilities. The disease is most prevalent in West Africa, but it is also found in non-tropical areas including Australia and Japan. It is often treated with drugs and surgery. This review compared different drug treatments for Buruli ulcer."
}
]
|
query-laysum | 4120 | [
{
"role": "user",
"content": "Abstract: Background\nAntenatal care (ANC) is a core component of maternity care. However, both quality of care provision and rates of attendance vary widely between and within countries. Qualitative research can assess factors underlying variation, including acceptability, feasibility, and the values and beliefs that frame provision and uptake of ANC programmes.\nThis synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. It was designed to inform the World Health Organization guidelines for a positive pregnancy experience and to provide insights for the design and implementation of improved antenatal care in the future.\nObjectives\nTo identify, appraise, and synthesise qualitative studies exploring:\n· Women’s views and experiences of attending ANC; and factors influencing the uptake of ANC arising from women’s accounts;\n· Healthcare providers’ views and experiences of providing ANC; and factors influencing the provision of ANC arising from the accounts of healthcare providers.\nSearch methods\nTo find primary studies we searched MEDLINE, Ovid; Embase, Ovid; CINAHL, EbscoHost; PsycINFO, EbscoHost; AMED, EbscoHost; LILACS, VHL; and African Journals Online (AJOL) from January 2000 to February 2019. We handsearched reference lists of included papers and checked the contents pages of 50 relevant journals through Zetoc alerts received during the searching phase.\nSelection criteria\nWe included studies that used qualitative methodology and that met our quality threshold; that explored the views and experiences of routine ANC among healthy, pregnant and postnatal women or among healthcare providers offering this care, including doctors, midwives, nurses, lay health workers and traditional birth attendants; and that took place in any setting where ANC was provided.\nWe excluded studies of ANC programmes designed for women with specific complications. We also excluded studies of programmes that focused solely on antenatal education.\nData collection and analysis\nTwo authors undertook data extraction, logged study characteristics, and assessed study quality. We used meta-ethnographic and Framework techniques to code and categorise study data. We developed findings from the data and presented these in a 'Summary of Qualitative Findings' (SoQF) table. We assessed confidence in each finding using GRADE-CERQual. We used these findings to generate higher-level explanatory thematic domains. We then developed two lines of argument syntheses, one from service user data, and one from healthcare provider data. In addition, we mapped the findings to relevant Cochrane effectiveness reviews to assess how far review authors had taken account of behavioural and organisational factors in the design and implementation of the interventions they tested. We also translated the findings into logic models to explain full, partial and no uptake of ANC, using the theory of planned behaviour.\nMain results\nWe include 85 studies in our synthesis. Forty-six studies explored the views and experiences of healthy pregnant or postnatal women, 17 studies explored the views and experiences of healthcare providers and 22 studies incorporated the views of both women and healthcare providers. The studies took place in 41 countries, including eight high-income countries, 18 middle-income countries and 15 low-income countries, in rural, urban and semi-urban locations. We developed 52 findings in total and organised these into three thematic domains: socio-cultural context (11 findings, five moderate- or high-confidence); service design and provision (24 findings, 15 moderate- or high-confidence); and what matters to women and staff (17 findings, 11 moderate- or high-confidence) The third domain was sub-divided into two conceptual areas; personalised supportive care, and information and safety. We also developed two lines of argument, using high- or moderate-confidence findings:\nFor women, initial or continued use of ANC depends on a perception that doing so will be a positive experience. This is a result of the provision of good-quality local services that are not dependent on the payment of informal fees and that include continuity of care that is authentically personalised, kind, caring, supportive, culturally sensitive, flexible, and respectful of women’s need for privacy, and that allow staff to take the time needed to provide relevant support, information and clinical safety for the woman and the baby, as and when they need it. Women’s perceptions of the value of ANC depend on their general beliefs about pregnancy as a healthy or a risky state, and on their reaction to being pregnant, as well as on local socio-cultural norms relating to the advantages or otherwise of antenatal care for healthy pregnancies, and for those with complications. Whether they continue to use ANC or not depends on their experience of ANC design and provision when they access it for the first time.\nThe capacity of healthcare providers to deliver the kind of high-quality, relationship-based, locally accessible ANC that is likely to facilitate access by women depends on the provision of sufficient resources and staffing as well as the time to provide flexible personalised, private appointments that are not overloaded with organisational tasks. Such provision also depends on organisational norms and values that overtly value kind, caring staff who make effective, culturally-appropriate links with local communities, who respect women’s belief that pregnancy is usually a normal life event, but who can recognise and respond to complications when they arise. Healthcare providers also require sufficient training and education to do their job well, as well as an adequate salary, so that they do not need to demand extra informal funds from women and families, to supplement their income, or to fund essential supplies.\nAuthors' conclusions\nThis review has identified key barriers and facilitators to the uptake (or not) of ANC services by pregnant women, and in the provision (or not) of good-quality ANC by healthcare providers. It complements existing effectiveness reviews of models of ANC provision and adds essential insights into why a particular type of ANC provided in specific local contexts may or may not be acceptable, accessible, or valued by some pregnant women and their families/communities. Those providing and funding services should consider the three thematic domains identified by the review as a basis for service development and improvement. Such developments should include pregnant and postnatal women, community members and other relevant stakeholders.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane qualitative evidence synthesis is to explore women’s and healthcare workers’ views and experiences of antenatal care. We collected and analysed all relevant qualitative studies to answer this question, and include 85 studies.\nThe synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. The synthesis was designed to inform the World Health Organization guidelines for a positive pregnancy experience."
}
]
|
query-laysum | 4121 | [
{
"role": "user",
"content": "Abstract: Background\nBenign prostatic hyperplasia (BPH) is a common condition in ageing men that may cause lower urinary tract symptoms (LUTS). Treatment aims are to relieve symptoms and prevent disease-related complications. Naftopidil is an alpha-blocker (AB) that has a high affinity for the A1d receptor that may have advantages in treating LUTS in this setting. This is an update of a Cochrane Review first published in 2009. Since that time, several large randomised controlled trials (RCTs) have been reported, making this update relevant.\nObjectives\nTo evaluate the effects of naftopidil for the treatment of LUTS associated with BPH.\nSearch methods\nWe performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, LILAC, and Web of Science), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up to 31 May 2018\nSelection criteria\nWe included all parallel RCTs. We also included cross-over design trials.\nData collection and analysis\nTwo review authors independently classified and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. Primary outcomes were urological symptom scores, quality of life (QoL) and treatment withdrawals for any reason; secondary outcomes were treatment withdrawals due to adverse events, acute urinary retention, surgical intervention for BPH, and cardiovascular and sexual adverse events. We considered outcomes measured up to 12 months after randomisation as short term, and later than 12 months as long term. We rated the certainty of the evidence according to the GRADE approach.\nMain results\nWe included 22 RCTs with 2223 randomised participants across four comparisons for short-term follow-up. This abstract focuses on only two of four comparisons for which we found data since two comparators (i.e. propiverine and Eviprostat (phytotherapy)) are rarely used. One study comparing naftopidil to placebo did not report any relevant outcomes and was therefore excluded. There were no trials that compared to combination therapy with naftopidil or any 5-alpha reductase inhibitors (5-ARIs) to combination therapy with other ABs and any 5-ARIs.\nAll included studies were conducted in Asian countries. Study duration ranged from four to 12 weeks. Mean age was 67.8 years, prostate volume was 35.4 mL, and International Prostate Symptom Score was 18.3. We were unable to perform any of the preplanned subgroup analyses based on age and baseline symptom score.\nNaftopidil versus tamsulosin\nBased on 12 studies with 965 randomised participants, naftopidil may have resulted in little or no difference in urological symptom score (mean difference (MD) 0.47, 95% confidence interval (CI) –0.09 to 1.04 measured on a scale from 0 to 35 with higher score representing increased symptoms), QoL (MD 0.11, 95% CI –0.09 to 0.30; measured on a scale from 0 to 6 with higher scores representing worse QoL), and treatment withdrawals for any reason (risk ratio (RR) 0.92, 95% CI 0.64 to 1.34; corresponding to 7 fewer per 1000 participants, 95% CI 32 fewer to 31 more). Naftopidil may have resulted in little to no difference in sexual adverse events (RR 0.54, 95% CI 0.24 to 1.22); this would result in 26 fewer sexual adverse events per 1000 participants (95% CI 43 fewer to 13 more). We rated the certainty of evidence as moderate for urological symptom score and low for the other outcomes.\nNaftopidil versus silodosin\nBased on five studies with 652 randomised participants, naftopidil may have resulted in little or no difference in the urological symptom scores (MD 1.04, 95% CI –0.78 to 2.85), QoL (MD 0.21, 95% CI –0.23 to 0.66), and treatment withdrawals for any reason (RR 0.80, 95% CI 0.52 to 1.23; corresponding to 26 fewer per 1000 participants, 95% CI 62 fewer to 32 more). We rated the certainty of evidence as low for all these outcomes. Naftopidil likely reduced sexual adverse events (RR 0.15, 95% CI 0.06 to 0.42; corresponding to 126 fewer sexual adverse events per 1000 participants, 95% CI 139 fewer to 86 fewer). We rated the certainty of evidence as moderate for sexual adverse events.\nAuthors' conclusions\nNaftopidil appears to have similar effects in the urological symptom scores and QoL compared to tamsulosin and silodosin. Naftopidil has similar sexual adverse events compared to tamsulosin but has fewer compared to silodosin.\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 22 studies with 2223 men. The average age was 68.0 years. These men had mostly symptoms rated as moderate or severe."
}
]
|
query-laysum | 4122 | [
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are often preferred over enteral nutrition (EN) as induction therapy for Crohn's disease (CD). Prior meta-analyses suggest that corticosteroids are superior to EN for induction of remission in CD. Treatment failures in EN trials are often due to poor compliance, with dropouts frequently due to poor acceptance of a nasogastric tube and unpalatable formulations. This systematic review is an update of a previously published Cochrane review.\nObjectives\nTo evaluate the effectiveness and safety of exclusive EN as primary therapy to induce remission in CD and to examine the importance of formula composition on effectiveness.\nSearch methods\nWe searched MEDLINE, Embase and CENTRAL from inception to 5 July 2017. We also searched references of retrieved articles and conference abstracts.\nSelection criteria\nRandomized controlled trials involving patients with active CD were considered for inclusion. Studies comparing one type of EN to another type of EN or conventional corticosteroids were selected for review.\nData collection and analysis\nData were extracted independently by at least two authors. The primary outcome was clinical remission. Secondary outcomes included adverse events, serious adverse events and withdrawal due to adverse events. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (CI). A random-effects model was used to pool data. We performed intention-to-treat and per-protocol analyses for the primary outcome. Heterogeneity was explored using the Chi2 and I2 statistics. The studies were separated into two comparisons: one EN formulation compared to another EN formulation and EN compared to corticosteroids. Subgroup analyses were based on formula composition and age. Sensitivity analyses included abstract publications and poor quality studies. We used the Cochrane risk of bias tool to assess study quality. We used the GRADE criteria to assess the overall quality of the evidence supporting the primary outcome and selected secondary outcomes.\nMain results\nTwenty-seven studies (1,011 participants) were included. Three studies were rated as low risk of bias. Seven studies were rated as high risk of bias and 17 were rated as unclear risk of bias due to insufficient information. Seventeen trials compared different formulations of EN, 13 studies compared one or more elemental formulas to a non-elemental formula, three studies compared EN diets of similar protein composition but different fat composition, and one study compared non-elemental diets differing in glutamine enrichment. Meta-analysis of 11 trials (378 participants) demonstrated no difference in remission rates. Sixty-four per cent (134/210) of patients in the elemental group achieved remission compared to 62% (105/168) of patients in the non-elemental group (RR 1.02, 95% CI 0.88 to 1.18; GRADE very low quality). A per-protocol analysis (346 participants) produced similar results (RR 1.04, 95% CI 0.91 to 1.18). Subgroup analyses performed to evaluate the different types of elemental and non-elemental diets (elemental, semi-elemental and polymeric) showed no differences in remission rates. An analysis of 7 trials including 209 patients treated with EN formulas of differing fat content (low fat: < 20 g/1000 kCal versus high fat: > 20 g/1000 kCal) demonstrated no difference in remission rates (RR 1.03; 95% CI 0.85 to 1.26). Very low fat content (< 3 g/1000 kCal) and very low long chain triglycerides demonstrated higher remission rates than higher content EN formulas. There was no difference between elemental and non-elemental diets in adverse event rates (RR 1.00, 95% CI 0.63 to 1.60; GRADE very low quality), or withdrawals due to adverse events (RR 1.29, 95% CI 0.80 to 2.09; GRADE very low quality). Common adverse events included nausea, vomiting, diarrhea and bloating.\nTen trials compared EN to steroid therapy. Meta-analysis of eight trials (223 participants) demonstrated no difference in remission rates between EN and steroids. Fifty per cent (111/223) of patients in the EN group achieved remission compared to 72% (133/186) of patients in the steroid group (RR 0.77, 95% CI 0.58 to 1.03; GRADE very low quality). Subgroup analysis by age showed a difference in remission rates for adults but not for children. In adults 45% (87/194) of EN patients achieved remission compared to 73% (116/158) of steroid patients (RR 0.65, 95% CI 0.52 to 0.82; GRADE very low quality). In children, 83% (24/29) of EN patients achieved remission compared to 61% (17/28) of steroid patients (RR 1.35, 95% CI 0.92 to 1.97; GRADE very low quality). A per-protocol analysis produced similar results (RR 0.93, 95% CI 0.75 to 1.14). The per-protocol subgroup analysis showed a difference in remission rates for both adults (RR 0.82, 95% CI 0.70 to 0.95) and children (RR 1.43, 95% CI 1.03 to 1.97). There was no difference in adverse event rates (RR 1.39, 95% CI 0.62 to 3.11; GRADE very low quality). However, patients on EN were more likely to withdraw due to adverse events than those on steroid therapy (RR 2.95, 95% CI 1.02 to 8.48; GRADE very low quality). Common adverse events reported in the EN group included heartburn, flatulence, diarrhea and vomiting, and for steroid therapy acne, moon facies, hyperglycemia, muscle weakness and hypoglycemia. The most common reason for withdrawal was inability to tolerate the EN diet.\nAuthors' conclusions\nVery low quality evidence suggests that corticosteroid therapy may be more effective than EN for induction of clinical remission in adults with active CD. Very low quality evidence also suggests that EN may be more effective than steroids for induction of remission in children with active CD. Protein composition does not appear to influence the effectiveness of EN for the treatment of active CD. EN should be considered in pediatric CD patients or in adult patients who can comply with nasogastric tube feeding or perceive the formulations to be palatable, or when steroid side effects are not tolerated or better avoided. Further research is required to confirm the superiority of corticosteroids over EN in adults. Further research is required to confirm the benefit of EN in children. More effort from industry should be taken to develop palatable polymeric formulations that can be delivered without use of a nasogastric tube as this may lead to increased patient adherence with this therapy\n\nGiven the provided abstract, please respond to the following query: \"What is Crohn's disease?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Crohn's disease is a long-term inflammation of the gastrointestinal (GI) tract, occurring anywhere from mouth to anus. Common symptoms of this condition include abdominal pain, diarrhea and weight loss. When Crohn's disease patients are experiencing symptoms, it is characterized to be 'active' disease. When the symptoms stop, it is called 'remission'."
}
]
|
query-laysum | 4123 | [
{
"role": "user",
"content": "Abstract: Background\nOutpatient care facilities provide a variety of basic healthcare services to individuals who do not require hospitalisation or institutionalisation, and are usually the patient's first contact. The provision of outpatient care contributes to immediate and large gains in health status, and a large portion of total health expenditure goes to outpatient healthcare services. Payment method is one of the most important incentive methods applied by purchasers to guide the performance of outpatient care providers.\nObjectives\nTo assess the impact of different payment methods on the performance of outpatient care facilities and to analyse the differences in impact of payment methods in different settings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), 2016, Issue 3, part of the Cochrane Library (searched 8 March 2016); MEDLINE, OvidSP (searched 8 March 2016); Embase, OvidSP (searched 24 April 2014); PubMed (NCBI) (searched 8 March 2016); Dissertations and Theses Database, ProQuest (searched 8 March 2016); Conference Proceedings Citation Index (ISI Web of Science) (searched 8 March 2016); IDEAS (searched 8 March 2016); EconLit, ProQuest (searched 8 March 2016); POPLINE, K4Health (searched 8 March 2016); China National Knowledge Infrastructure (searched 8 March 2016); Chinese Medicine Premier (searched 8 March 2016); OpenGrey (searched 8 March 2016); ClinicalTrials.gov, US National Institutes of Health (NIH) (searched 8 March 2016); World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 8 March 2016); and the website of the World Bank (searched 8 March 2016).\nIn addition, we searched the reference lists of included studies and carried out a citation search for the included studies via ISI Web of Science to find other potentially relevant studies. We also contacted authors of the main included studies regarding any further published or unpublished work.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies that compared different payment methods for outpatient health facilities. We defined outpatient care facilities in this review as facilities that provide health services to individuals who do not require hospitalisation or institutionalisation. We only included methods used to transfer funds from the purchaser of healthcare services to health facilities (including groups of individual professionals). These include global budgets, line-item budgets, capitation, fee-for-service (fixed and unconstrained), pay for performance, and mixed payment. The primary outcomes were service provision outcomes, patient outcomes, healthcare provider outcomes, costs for providers, and any adverse effects.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the risk of bias. We conducted a structured synthesis. We first categorised the comparisons and outcomes and then described the effects of different types of payment methods on different categories of outcomes. We used a fixed-effect model for meta-analysis within a study if a study included more than one indicator in the same category of outcomes. We used a random-effects model for meta-analysis across studies. If the data for meta-analysis were not available in some studies, we calculated the median and interquartile range. We reported the risk ratio (RR) for dichotomous outcomes and the relative change for continuous outcomes.\nMain results\nWe included 21 studies from Afghanistan, Burundi, China, Democratic Republic of Congo, Rwanda, Tanzania, the United Kingdom, and the United States of health facilities providing primary health care and mental health care. There were three kinds of payment comparisons.\n1) Pay for performance (P4P) combined with some existing payment method (capitation or different kinds of input-based payment) compared to the existing payment method\nWe included 18 studies in this comparison, however we did not include five studies in the effects analysis due to high risk of bias. From the 13 studies, we found that the extra P4P incentives probably slightly improved the health professionals' use of some tests and treatments (adjusted RR median = 1.095, range 1.01 to 1.17; moderate-certainty evidence), and probably led to little or no difference in adherence to quality assurance criteria (adjusted percentage change median = -1.345%, range -8.49% to 5.8%; moderate-certainty evidence). We also found that P4P incentives may have led to little or no difference in patients' utilisation of health services (adjusted RR median = 1.01, range 0.96 to 1.15; low-certainty evidence) and may have led to little or no difference in the control of blood pressure or cholesterol (adjusted RR = 1.01, range 0.98 to 1.04; low-certainty evidence).\n2) Capitation combined with P4P compared to fee-for-service (FFS)\nOne study found that compared with FFS, a capitated budget combined with payment based on providers' performance on antibiotic prescriptions and patient satisfaction probably slightly reduced antibiotic prescriptions in primary health facilities (adjusted RR 0.84, 95% confidence interval 0.74 to 0.96; moderate-certainty evidence).\n3) Capitation compared to FFS\nTwo studies compared capitation to FFS in mental health centres in the United States. Based on these studies, the effects of capitation compared to FFS on the utilisation and costs of services were uncertain (very low-certainty evidence).\nAuthors' conclusions\nOur review found that if policymakers intend to apply P4P incentives to pay health facilities providing outpatient services, this intervention will probably lead to a slight improvement in health professionals' use of tests or treatments, particularly for chronic diseases. However, it may lead to little or no improvement in patients' utilisation of health services or health outcomes. When considering using P4P to improve the performance of health facilities, policymakers should carefully consider each component of their P4P design, including the choice of performance measures, the performance target, payment frequency, if there will be additional funding, whether the payment level is sufficient to change the behaviours of health providers, and whether the payment to facilities will be allocated to individual professionals. Unfortunately, the studies included in this review did not help to inform those considerations.\nWell-designed comparisons of different payment methods for outpatient health facilities in low- and middle-income countries and studies directly comparing different designs (e.g. different payment levels) of the same payment method (e.g. P4P or FFS) are needed.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Many healthcare services are offered to patients through outpatient facilities rather than to inpatients in hospitals. Outpatient facilities are also known as ambulatory care facilities, and include primary healthcare centres, outpatient clinics, urgent care centres, family planning centres, mental health centres, and dental clinics.\nDifferent systems to reimburse outpatient (ambulatory) care facilities for their services are available to governments and health insurers. These systems include:\n• budget systems, where the facility is given a fixed amount of money in advance to cover expenses for a fixed period;\n• capitation payment systems, where the facility is paid a fixed amount of money in advance to provide specific services to each enrolled patient for a fixed period;\n• fee-for-service systems, where payment is based on the specific services that the healthcare facility provides;\n• pay-for-performance systems, where payment is partly based on the performance of the facility's healthcare providers.\nDifferent payment systems can have different effects on how healthcare facilities deliver care. These changes can be intentional or unintentional and can lead to both benefits and harms. At best, a payment system can encourage healthcare providers to offer the right healthcare services to the right patients in the best and most cost-efficient way. However, payment systems can also lead providers to offer poor-quality, expensive, and unnecessary care, which can ultimately have a negative impact on patients' health.\nThis Cochrane review assessed the effect of different payment systems for outpatient care facilities. Other Cochrane reviews have assessed the effect of different payment systems for individual healthcare professionals and for inpatient facilities."
}
]
|
query-laysum | 4124 | [
{
"role": "user",
"content": "Abstract: Background\nFailure of implantation and conception may result from inability of the blastocyst to escape from its outer coat, which is known as the zona pellucida. Artificial disruption of this coat is known as assisted hatching and has been proposed as a method for improving the success of assisted conception by facilitating embryo implantation.\nObjectives\nTo determine effects of assisted hatching (AH) of embryos derived from assisted conception on live birth and multiple pregnancy rates.\nSearch methods\nWe searched the following databases (from their inception to 27 May 2020), with no language or date restriction: Cochrane Gynaecology and Fertility Group (CGFG) specialised register, CENTRAL, MEDLINE, Embase and PsycINFO. We checked reference lists of relevant studies and searched the trial registers.\nSelection criteria\nTwo review authors identified and independently screened trials. We included randomised controlled trials (RCTs) of AH (mechanical, chemical, or laser disruption of the zona pellucida before embryo replacement) versus no AH that reported live birth or clinical pregnancy data.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Two review authors independently performed quality assessments and data extraction.\nMain results\nWe included 39 RCTs (7249 women). All reported clinical pregnancy data, including 2486 clinical pregnancies. Only 14 studies reported live birth data, with 834 live birth events. The quality of evidence ranged from very low to low. The main limitations were serious risk of bias associated with poor reporting of study methods, inconsistency, imprecision, and publication bias. Five trials are currently ongoing.\nWe are uncertain whether assisted hatching improved live birth rates compared to no assisted hatching (odds ratio (OR) 1.09, 95% confidence interval (CI) 0.92 to 1.29; 14 RCTs, N = 2849; I² = 20%; low-quality evidence). This analysis suggests that if the live birth rate in women not using assisted hatching is about 28%, the rate in those using assisted hatching will be between 27% and 34%.\nAnalysis of multiple pregnancy rates per woman showed that in women who were randomised to AH compared with women randomised to no AH, there may have been a slight increase in multiple pregnancy rates (OR 1.38, 95% CI 1.13 to 1.68; 18 RCTs, N = 4308; I² = 48%; low-quality evidence). This suggests that if the multiple pregnancy rate in women not using assisted hatching is about 9%, the rate in those using assisted hatching will be between 10% and 14%.\nWhen all of the included studies (39) are pooled, the clinical pregnancy rate in women who underwent AH may improve slightly in comparison to no AH (OR 1.20, 95% CI 1.09 to 1.33; 39 RCTs, N = 7249; I² = 55%; low-quality evidence). However, when a random-effects model is used due to high heterogeneity, there may be little to no difference in clinical pregnancy rate (P = 0.04).\nAll 14 RCTs that reported live birth rates also reported clinical pregnancy rates, and analysis of these studies illustrates that AH may make little to no difference in clinical pregnancy rates when compared to no AH (OR 1.07, 95% CI 0.92 to 1.25; 14 RCTs, N = 2848; I² = 45%).\nWe are uncertain about whether AH affects miscarriage rates due to the quality of the evidence (OR 1.13, 95% CI 0.82 to 1.56; 17 RCTs, N = 2810; I² = 0%; very low-quality evidence).\nAuthors' conclusions\nThis update suggests that we are uncertain of the effects of assisted hatching (AH) on live birth rates. AH may lead to increased risk of multiple pregnancy. The risks of complications associated with multiple pregnancy may be increased without evidence to demonstrate an increase in live birth rate, warranting careful consideration of the routine use of AH for couples undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).\nAH may offer a slightly increased chance of achieving a clinical pregnancy, but data quality was of low grade. We are uncertain about whether AH influences miscarriage rates.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does assisted hatching (help to hatch human embryos in the laboratory) during assisted reproduction improve the chance of achieving pregnancy and live birth, and does it affect the risk of multiple pregnancy?"
}
]
|
query-laysum | 4125 | [
{
"role": "user",
"content": "Abstract: Background\nConcerns regarding the safety and availability of transfused donor blood have prompted research into a range of techniques to minimise allogeneic transfusion requirements. Cell salvage (CS) describes the recovery of blood from the surgical field, either during or after surgery, for reinfusion back to the patient.\nObjectives\nTo examine the effectiveness of CS in minimising perioperative allogeneic red blood cell transfusion and on other clinical outcomes in adults undergoing elective or non-urgent surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers for randomised controlled trials (RCTs) and systematic reviews from 2009 (date of previous search) to 19 January 2023, without restrictions on language or publication status.\nSelection criteria\nWe included RCTs assessing the use of CS compared to no CS in adults (participants aged 18 or over, or using the study's definition of adult) undergoing elective (non-urgent) surgery only.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 106 RCTs, incorporating data from 14,528 participants, reported in studies conducted in 24 countries. Results were published between 1978 and 2021. We analysed all data according to a single comparison: CS versus no CS. We separated analyses by type of surgery.\nThe certainty of the evidence varied from very low certainty to high certainty. Reasons for downgrading the certainty included imprecision (small sample sizes below the optimal information size required to detect a difference, and wide confidence intervals), inconsistency (high statistical heterogeneity), and risk of bias (high risk from domains including sequence generation, blinding, and baseline imbalances).\nAggregate analysis (all surgeries combined: primary outcome only)\nVery low-certainty evidence means we are uncertain if there is a reduction in the risk of allogeneic transfusion with CS (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.59 to 0.72; 82 RCTs, 12,520 participants).\nCancer: 2 RCTs (79 participants)\nVery low-certainty evidence means we are uncertain whether there is a difference for mortality, blood loss, infection, or deep vein thrombosis (DVT). There were no analysable data reported for the remaining outcomes.\nCardiovascular (vascular): 6 RCTs (384 participants)\nVery low- to low-certainty evidence means we are uncertain whether there is a difference for most outcomes. No data were reported for major adverse cardiovascular events (MACE).\nCardiovascular (no bypass): 6 RCTs (372 participants)\nModerate-certainty evidence suggests there is probably a reduction in risk of allogeneic transfusion with CS (RR 0.82, 95% CI 0.69 to 0.97; 3 RCTs, 169 participants).\nVery low- to low-certainty evidence means we are uncertain whether there is a difference for volume transfused, blood loss, mortality, re-operation for bleeding, infection, wound complication, myocardial infarction (MI), stroke, and hospital length of stay (LOS). There were no analysable data reported for thrombosis, DVT, pulmonary embolism (PE), and MACE.\nCardiovascular (with bypass): 29 RCTs (2936 participants)\nLow-certainty evidence suggests there may be a reduction in the risk of allogeneic transfusion with CS, and suggests there may be no difference in risk of infection and hospital LOS.\nVery low- to moderate-certainty evidence means we are uncertain whether there is a reduction in volume transfused because of CS, or if there is any difference for mortality, blood loss, re-operation for bleeding, wound complication, thrombosis, DVT, PE, MACE, and MI, and probably no difference in risk of stroke.\nObstetrics: 1 RCT (1356 participants)\nHigh-certainty evidence shows there is no difference between groups for mean volume of allogeneic blood transfused (mean difference (MD) -0.02 units, 95% CI -0.08 to 0.04; 1 RCT, 1349 participants).\nLow-certainty evidence suggests there may be no difference for risk of allogeneic transfusion. There were no analysable data reported for the remaining outcomes.\nOrthopaedic (hip only): 17 RCTs (2055 participants)\nVery low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, or if there is any difference between groups for mortality, blood loss, re-operation for bleeding, infection, wound complication, prosthetic joint infection (PJI), thrombosis, DVT, PE, stroke, and hospital LOS. There were no analysable data reported for MACE and MI.\nOrthopaedic (knee only): 26 RCTs (2568 participants)\nVery low- to low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, and whether there is a difference for blood loss, re-operation for bleeding, infection, wound complication, PJI, DVT, PE, MI, MACE, stroke, and hospital LOS. There were no analysable data reported for mortality and thrombosis.\nOrthopaedic (spine only): 6 RCTs (404 participants)\nModerate-certainty evidence suggests there is probably a reduction in the need for allogeneic transfusion with CS (RR 0.44, 95% CI 0.31 to 0.63; 3 RCTs, 194 participants).\nVery low- to moderate-certainty evidence suggests there may be no difference for volume transfused, blood loss, infection, wound complication, and PE. There were no analysable data reported for mortality, re-operation for bleeding, PJI, thrombosis, DVT, MACE, MI, stroke, and hospital LOS.\nOrthopaedic (mixed): 14 RCTs (4374 participants)\nVery low- to low-certainty evidence means we are uncertain if there is a reduction in the need for allogeneic transfusion with CS, or if there is any difference between groups for volume transfused, mortality, blood loss, infection, wound complication, PJI, thrombosis, DVT, MI, and hospital LOS. There were no analysable data reported for re-operation for bleeding, MACE, and stroke.\nAuthors' conclusions\nIn some types of elective surgery, cell salvage may reduce the need for and volume of allogeneic transfusion, alongside evidence of no difference in adverse events, when compared to no cell salvage. Further research is required to establish why other surgeries show no benefit from CS, through further analysis of the current evidence. More large RCTs in under-reported specialities are needed to expand the evidence base for exploring the impact of CS.\n\nGiven the provided abstract, please respond to the following query: \"Cardiovascular (heart surgery with bypass)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "29 studies (2936 participants)\nThere may be a reduction in the risk of needing a transfusion of donated blood because of cell salvage. For other outcomes, we are uncertain of the impact of cell salvage."
}
]
|
query-laysum | 4126 | [
{
"role": "user",
"content": "Abstract: Background\nEchocardiogram is the reference standard for the diagnosis of haemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. A simple blood assay for brain natriuretic peptide (BNP) or amino-terminal pro-B-type natriuretic peptide (NT-proBNP) may be useful in the diagnosis and management of hsPDA, but a summary of the diagnostic accuracy has not been reviewed recently.\nObjectives\nPrimary objective: To determine the diagnostic accuracy of the cardiac biomarkers BNP and NT-proBNP for diagnosis of haemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates. Our secondary objectives were: to compare the accuracy of BNP and NT-proBNP; and to explore possible sources of heterogeneity among studies evaluating BNP and NT-proBNP, including type of commercial assay, chronological age of the infant at testing, gestational age at birth, whether used to initiate medical or surgical treatment, test threshold, and criteria of the reference standard (type of echocardiographic parameter used for diagnosis, clinical symptoms or physical signs if data were available).\nSearch methods\nWe searched the following databases in September 2021: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science. We also searched clinical trial registries and conference abstracts. We checked references of included studies and conducted cited reference searches of included studies. We did not apply any language or date restrictions to the electronic searches or use methodological filters, so as to maximise sensitivity.\nSelection criteria\nWe included prospective or retrospective, cohort or cross-sectional studies, which evaluated BNP or NT-proBNP (index tests) in preterm infants (participants) with suspected hsPDA (target condition) in comparison with echocardiogram (reference standard).\nData collection and analysis\nTwo authors independently screened title/abstracts and full-texts, resolving any inclusion disagreements through discussion or with a third reviewer. We extracted data from included studies to create 2 × 2 tables. Two independent assessors performed quality assessment using the Quality Assessment of Diagnostic-Accuracy Studies-2 (QUADAS 2) tool. We excluded studies that did not report data in sufficient detail to construct 2 × 2 tables, and where this information was not available from the primary investigators. We used bivariate and hierarchical summary receiver operating characteristic (HSROC) random-effects models for meta-analysis and generated summary receiver operating characteristic space (ROC) curves. Since both BNP and NTproBNP are continuous variables, sensitivity and specificity were reported at multiple thresholds. We dealt with the threshold effect by reporting summary ROC curves without summary points.\nMain results\nWe included 34 studies: 13 evaluated BNP and 21 evaluated NT-proBNP in the diagnosis of hsPDA. Studies varied by methodological quality, type of commercial assay, thresholds, age at testing, gestational age and whether the assay was used to initiate medical or surgical therapy. We noted some variability in the definition of hsPDA among the included studies.\nFor BNP, the summary curve is reported in the ROC space (13 studies, 768 infants, low-certainty evidence). The estimated specificities from the ROC curve at fixed values of sensitivities at median (83%), lower and upper quartiles (79% and 92%) were 93.6% (95% confidence interval (CI) 77.8 to 98.4), 95.5% (95% CI 83.6 to 98.9) and 81.1% (95% CI 50.6 to 94.7), respectively. Subgroup comparisons revealed differences by type of assay and better diagnostic accuracy at lower threshold cut-offs (< 250 pg/ml compared to ≥ 250 pg/ml), testing at gestational age < 30 weeks and chronological age at testing at one to three days. Data were insufficient for subgroup analysis of whether the BNP testing was indicated for medical or surgical management of PDA.\nFor NT-proBNP, the summary ROC curve is reported in the ROC space (21 studies, 1459 infants, low-certainty evidence). The estimated specificities from the ROC curve at fixed values of sensitivities at median (92%), lower and upper quartiles (85% and 94%) were 83.6% (95% CI 73.3 to 90.5), 90.6% (95% CI 83.8 to 94.7) and 79.4% (95% CI 67.5 to 87.8), respectively. Subgroup analyses by threshold (< 6000 pg/ml and ≥ 6000 pg/ml) did not reveal any differences. Subgroup analysis by mean gestational age (< 30 weeks vs 30 weeks and above) showed better accuracy with < 30 weeks, and chronological age at testing (days one to three vs over three) showed testing at days one to three had better diagnostic accuracy. Data were insufficient for subgroup analysis of whether the NTproBNP testing was indicated for medical or surgical management of PDA.\nWe performed meta-regression for BNP and NT-proBNP using the covariates: assay type, threshold, mean gestational age and chronological age; none of the covariates significantly affected summary sensitivity and specificity.\nAuthors' conclusions\nLow-certainty evidence suggests that BNP and NT-proBNP have moderate accuracy in diagnosing hsPDA and may work best as a triage test to select infants for echocardiography. The studies evaluating the diagnostic accuracy of BNP and NT-proBNP for hsPDA varied considerably by assay characteristics (assay kit and threshold) and infant characteristics (gestational and chronological age); hence, generalisability between centres is not possible. We recommend that BNP or NT-proBNP assays be locally validated for specific populations and outcomes, to initiate therapy or follow response to therapy.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review included studies published up to September 2021."
}
]
|
query-laysum | 4127 | [
{
"role": "user",
"content": "Abstract: Background\nPrinted educational materials are widely used dissemination strategies to improve the quality of healthcare professionals' practice and patient health outcomes. Traditionally they are presented in paper formats such as monographs, publication in peer-reviewed journals and clinical guidelines. This is the fourth update of the review.\nObjectives\nTo assess the effect of printed educational materials (PEMs) on the practice of healthcare professionals and patient health outcomes.\nTo explore the influence of some of the characteristics of the printed educational materials (e.g. source, content, format) on their effect on healthcare professionals' practice and patient health outcomes.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), HealthStar, CINAHL, ERIC, CAB Abstracts, Global Health, and EPOC Register from their inception to 6 February 2019. We checked the reference lists of all included studies and relevant systematic reviews.\nSelection criteria\nWe included randomised trials (RTs), controlled before-after studies (CBAs) and interrupted time series studies (ITSs) that evaluated the impact of PEMs on healthcare professionals' practice or patient health outcomes. We included three types of comparisons: (1) PEM versus no intervention, (2) PEM versus single intervention, (3) multifaceted intervention where PEM is included versus multifaceted intervention without PEM. Any objective measure of professional practice (e.g. prescriptions for a particular drug), or patient health outcomes (e.g. blood pressure) were included.\nData collection and analysis\nTwo reviewers undertook data extraction independently. Disagreements were resolved by discussion. For analyses, we grouped the included studies according to study design, type of outcome and type of comparison. For controlled trials, we reported the median effect size for each outcome within each study, the median effect size across outcomes for each study and the median of these effect sizes across studies. Where data were available, we re-analysed the ITS studies by converting all data to a monthly basis and estimating the effect size from the change in the slope of the regression line between before and after implementation of the PEM. We reported median changes in slope for each outcome, for each study, and then across studies. We standardised all changes in slopes by their standard error, allowing comparisons and combination of different outcomes. We categorised each PEM according to potential effects modifiers related to the source of the PEMs, the channel used for their delivery, their content, and their format. We assessed the risks of bias of all the included studies.\nMain results\nWe included 84 studies: 32 RTs, two CBAs and 50 ITS studies. Of the 32 RTs, 19 were cluster RTs that used various units of randomisation, such as practices, health centres, towns, or areas.\nThe majority of the included studies (82/84) compared the effectiveness of PEMs to no intervention. Based on the RTs that provided moderate-certainty evidence, we found that PEMs distributed to healthcare professionals probably improve their practice, as measured with dichotomous variables, compared to no intervention (median absolute risk difference (ARD): 0.04; interquartile range (IQR): 0.01 to 0.09; 3,963 healthcare professionals randomised within 3073 units). We could not confirm this finding using the evidence gathered from continuous variables (standardised mean difference (SMD): 0.11; IQR: -0.16 to 0.52; 1631 healthcare professionals randomised within 1373 units ), from the ITS studies (standardised median change in slope = 0.69; 35 studies), or from the CBA study because the certainty of this evidence was very low. We also found, based on RTs that provided moderate-certainty evidence, that PEMs distributed to healthcare professionals probably make little or no difference to patient health as measured using dichotomous variables, compared to no intervention (ARD: 0.02; IQR: -0.005 to 0.09; 935,015 patients randomised within 959 units). The evidence gathered from continuous variables (SMD: 0.05; IQR: -0.12 to 0.09; 6,737 patients randomised within 594 units) or from ITS study results (standardised median change in slope = 1.12; 8 studies) do not strengthen these findings because the certainty of this evidence was very low.\nTwo studies (a randomised trial and a CBA) compared a paper-based version to a computerised version of the same PEM. From the RT that provided evidence of low certainty, we found that PEM in computerised versions may make little or no difference to professionals' practice compared to PEM in printed versions (ARD: -0.02; IQR: -0.03 to 0.00; 139 healthcare professionals randomised individually). This finding was not strengthened by the CBA study that provided very low certainty evidence (SMD: 0.44; 32 healthcare professionals).\nThe data gathered did not allow us to conclude which PEM characteristics influenced their effectiveness.\nThe methodological quality of the included studies was variable. Half of the included RTs were at risk of selection bias. Most of the ITS studies were conducted retrospectively, without prespecifying the expected effect of the intervention, or acknowledging the presence of a secular trend.\nAuthors' conclusions\nThe results of this review suggest that, when used alone and compared to no intervention, PEMs may slightly improve healthcare professionals' practice outcomes and patient health outcomes. The effectiveness of PEMs compared to other interventions, or of PEMs as part of a multifaceted intervention, is uncertain.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies that had been published up to 8 February 2019."
}
]
|
query-laysum | 4128 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary.\nThis is the second update of the review first published in 2004.\nObjectives\nTo evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries.\nSelection criteria\nWe included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older).\nData collection and analysis\nWe independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables.\nMain results\nWe included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events.\n1. Haloperidol versus placebo\nThere may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) −0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium).\nHaloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD −0.14, 95% −0.28 to −0.00; 123 participants with mild- to moderate-severity delirium).\nHaloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).\n2. Haloperidol versus risperidone\nThere may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD −0.42, 95% CI −0.90 to 0.06; 126 participants) or 48 hours (MD −0.36, 95% CI −0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison.\n3. Haloperidol versus olanzapine\nWe are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI −0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI −1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison.\n4. Risperidone versus placebo\nRisperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium).\nThere may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD −0.05, 95% CI −0.19 to 0.09; 111 participants with mild- to moderate-severity delirium).\nRisperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium).\n5. Lorazepam plus haloperidol versus placebo plus haloperidol\nWe are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI −1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI −0.19 to 2.63; 31 participants with moderate to severe delirium).\n6. Haloperidol versus chlorpromazine\nWe are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI −4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI −4.22 to 5.14; 24 participants).\n7. Haloperidol versus lorazepam\nWe are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD −4.88, 95% CI −9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD −6.66, 95% CI −14.85 to 1.53; 17 participants).\n8. Lorazepam versus chlorpromazine\nWe are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported.\nSecondary outcomes: use of rescue medication, cognitive impairment, survival\nThere were insufficient data to draw conclusions or assess GRADE.\nAuthors' conclusions\nWe found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.\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": "We found low-quality evidence that, compared to placebo, drug therapy (specifically haloperidol and risperidone) may slightly worsen delirium symptoms in terminally ill people with delirium of mild to moderate severity. We found low- to moderate-quality evidence that these drugs may slightly increase adverse side effects. Given the small numbers of studies and participants on which current evidence is based, further research is essential."
}
]
|
query-laysum | 4129 | [
{
"role": "user",
"content": "Abstract: Background\nSince the approval of tyrosine kinase inhibitors, angiogenesis inhibitors and immune checkpoint inhibitors, the treatment landscape for advanced renal cell carcinoma (RCC) has changed fundamentally. Today, combined therapies from different drug categories have a firm place in a complex first-line therapy. Due to the large number of drugs available, it is necessary to identify the most effective therapies, whilst considering their side effects and impact on quality of life (QoL).\nObjectives\nTo evaluate and compare the benefits and harms of first-line therapies for adults with advanced RCC, and to produce a clinically relevant ranking of therapies. Secondary objectives were to maintain the currency of the evidence by conducting continuous update searches, using a living systematic review approach, and to incorporate data from clinical study reports (CSRs).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, conference proceedings and relevant trial registries up until 9 February 2022. We searched several data platforms to identify CSRs.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating at least one targeted therapy or immunotherapy for first-line treatment of adults with advanced RCC. We excluded trials evaluating only interleukin-2 versus interferon-alpha as well as trials with an adjuvant treatment setting. We also excluded trials with adults who received prior systemic anticancer therapy if more than 10% of participants were previously treated, or if data for untreated participants were not separately extractable.\nData collection and analysis\nAll necessary review steps (i.e. screening and study selection, data extraction, risk of bias and certainty assessments) were conducted independently by at least two review authors. Our outcomes were overall survival (OS), QoL, serious adverse events (SAEs), progression-free survival (PFS), adverse events (AEs), the number of participants who discontinued study treatment due to an AE, and the time to initiation of first subsequent therapy. Where possible, analyses were conducted for the different risk groups (favourable, intermediate, poor) according to the International Metastatic Renal-Cell Carcinoma Database Consortium Score (IMDC) or the Memorial Sloan Kettering Cancer Center (MSKCC) criteria. Our main comparator was sunitinib (SUN). A hazard ratio (HR) or risk ratio (RR) lower than 1.0 is in favour of the experimental arm.\nMain results\nWe included 36 RCTs and 15,177 participants (11,061 males and 4116 females). Risk of bias was predominantly judged as being 'high' or 'some concerns' across most trials and outcomes. This was mainly due to a lack of information about the randomisation process, the blinding of outcome assessors, and methods for outcome measurements and analyses. Additionally, study protocols and statistical analysis plans were rarely available.\nHere we present the results for our primary outcomes OS, QoL, and SAEs, and for all risk groups combined for contemporary treatments: pembrolizumab + axitinib (PEM+AXI), avelumab + axitinib (AVE+AXI), nivolumab + cabozantinib (NIV+CAB), lenvatinib + pembrolizumab (LEN+PEM), nivolumab + ipilimumab (NIV+IPI), CAB, and pazopanib (PAZ). Results per risk group and results for our secondary outcomes are reported in the summary of findings tables and in the full text of this review. The evidence on other treatments and comparisons can also be found in the full text.\nOverall survival (OS)\nAcross risk groups, PEM+AXI (HR 0.73, 95% confidence interval (CI) 0.50 to 1.07, moderate certainty) and NIV+IPI (HR 0.69, 95% CI 0.69 to 1.00, moderate certainty) probably improve OS, compared to SUN, respectively. LEN+PEM may improve OS (HR 0.66, 95% CI 0.42 to 1.03, low certainty), compared to SUN. There is probably little or no difference in OS between PAZ and SUN (HR 0.91, 95% CI 0.64 to 1.32, moderate certainty), and we are uncertain whether CAB improves OS when compared to SUN (HR 0.84, 95% CI 0.43 to 1.64, very low certainty). The median survival is 28 months when treated with SUN. Survival may improve to 43 months with LEN+PEM, and probably improves to: 41 months with NIV+IPI, 39 months with PEM+AXI, and 31 months with PAZ. We are uncertain whether survival improves to 34 months with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nQuality of life (QoL)\nOne RCT measured QoL using FACIT-F (score range 0 to 52; higher scores mean better QoL) and reported that the mean post-score was 9.00 points higher (9.86 lower to 27.86 higher, very low certainty) with PAZ than with SUN. Comparison data were not available for PEM+AXI, AVE+AXI, NIV+CAB, LEN+PEM, NIV+IPI, and CAB.\nSerious adverse events (SAEs)\nAcross risk groups, PEM+AXI probably increases slightly the risk for SAEs (RR 1.29, 95% CI 0.90 to 1.85, moderate certainty) compared to SUN. LEN+PEM (RR 1.52, 95% CI 1.06 to 2.19, moderate certainty) and NIV+IPI (RR 1.40, 95% CI 1.00 to 1.97, moderate certainty) probably increase the risk for SAEs, compared to SUN, respectively. There is probably little or no difference in the risk for SAEs between PAZ and SUN (RR 0.99, 95% CI 0.75 to 1.31, moderate certainty). We are uncertain whether CAB reduces or increases the risk for SAEs (RR 0.92, 95% CI 0.60 to 1.43, very low certainty) when compared to SUN. People have a mean risk of 40% for experiencing SAEs when treated with SUN. The risk increases probably to: 61% with LEN+PEM, 57% with NIV+IPI, and 52% with PEM+AXI. It probably remains at 40% with PAZ. We are uncertain whether the risk reduces to 37% with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nAuthors' conclusions\nFindings concerning the main treatments of interest comes from direct evidence of one trial only, thus results should be interpreted with caution. More trials are needed where these interventions and combinations are compared head-to-head, rather than just to SUN. Moreover, assessing the effect of immunotherapies and targeted therapies on different subgroups is essential and studies should focus on assessing and reporting relevant subgroup data. The evidence in this review mostly applies to advanced clear cell RCC.\n\nGiven the provided abstract, please respond to the following query: \"What is advanced RCC, and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "RCC is a type of kidney cancer. It is more common in older people and in men than in women. This is because age (≥60 years) and male sex put people at higher risk of getting it. Other risk factors include body weight, smoking, a history of kidney stones and high blood pressure. More than half of people with RCC discover they have it from routine health check-ups, because many do not have symptoms in the early stages. When symptoms appear, they can impact people's quality of life and day-to-day activities. Before 2005, drugs for treatment of advanced RCC were few and treatments caused many side effects. Now, there are new types of drugs: immunotherapy (use people’s own immune system to find and destroy cancer cells), or targeted therapy (interferes with molecules that are responsible for helping cancer cells to grow, divide, and spread). Combinations of these drugs are used for therapy. With these drugs, people may live longer, with a good quality of life and fewer or milder side effects. These drugs are evaluated in clinical studies with people with RCC."
}
]
|
query-laysum | 4130 | [
{
"role": "user",
"content": "Abstract: Background\nMost people with Parkinson’s disease (PD) experience at least one fall during the course of their disease. Several interventions designed to reduce falls have been studied. An up-to-date synthesis of evidence for interventions to reduce falls in people with PD will assist with informed decisions regarding fall-prevention interventions for people with PD.\nObjectives\nTo assess the effects of interventions designed to reduce falls in people with PD.\nSearch methods\nCENTRAL, MEDLINE, Embase, four other databases and two trials registers were searched on 16 July 2020, together with reference checking, citation searching and contact with study authors to identify additional studies. We also conducted a top-up search on 13 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) of interventions that aimed to reduce falls in people with PD and reported the effect on falls. We excluded interventions that aimed to reduce falls due to syncope.\nData collection and analysis\nWe used standard Cochrane Review procedures. Primary outcomes were rate of falls and number of people who fell at least once. Secondary outcomes were the number of people sustaining one or more fall-related fractures, quality of life, adverse events and economic outcomes. The certainty of the evidence was assessed using GRADE.\nMain results\nThis review includes 32 studies with 3370 participants randomised. We included 25 studies of exercise interventions (2700 participants), three studies of medication interventions (242 participants), one study of fall-prevention education (53 participants) and three studies of exercise plus education (375 participants). Overall, participants in the exercise trials and the exercise plus education trials had mild to moderate PD, while participants in the medication trials included those with more advanced disease. All studies had a high or unclear risk of bias in one or more items. Illustrative risks demonstrating the absolute impact of each intervention are presented in the summary of findings tables.\nTwelve studies compared exercise (all types) with a control intervention (an intervention not thought to reduce falls, such as usual care or sham exercise) in people with mild to moderate PD. Exercise probably reduces the rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.63 to 0.87; 1456 participants, 12 studies; moderate-certainty evidence). Exercise probably slightly reduces the number of people experiencing one or more falls by 10% (risk ratio (RR) 0.90, 95% CI 0.80 to 1.00; 932 participants, 9 studies; moderate-certainty evidence).\nWe are uncertain whether exercise makes little or no difference to the number of people experiencing one or more fall-related fractures (RR 0.57, 95% CI 0.28 to 1.17; 989 participants, 5 studies; very low-certainty evidence). Exercise may slightly improve health-related quality of life immediately following the intervention (standardised mean difference (SMD) -0.17, 95% CI -0.36 to 0.01; 951 participants, 5 studies; low-certainty evidence). We are uncertain whether exercise has an effect on adverse events or whether exercise is a cost-effective intervention for fall prevention.\nThree studies trialled a cholinesterase inhibitor (rivastigmine or donepezil). Cholinesterase inhibitors may reduce the rate of falls by 50% (RaR 0.50, 95% CI 0.44 to 0.58; 229 participants, 3 studies; low-certainty evidence). However, we are uncertain if this medication makes little or no difference to the number of people experiencing one or more falls (RR 1.01, 95% CI 0.90 to 1.14; 230 participants, 3 studies) and to health-related quality of life (EQ5D Thermometer mean difference (MD) 3.00, 95% CI -3.06 to 9.06; very low-certainty evidence). Cholinesterase inhibitors may increase the rate of non fall-related adverse events by 60% (RaR 1.60, 95% CI 1.28 to 2.01; 175 participants, 2 studies; low-certainty evidence). Most adverse events were mild and transient in nature. No data was available regarding the cost-effectiveness of medication for fall prevention.\nWe are uncertain of the effect of education compared to a control intervention on the number of people who fell at least once (RR 10.89, 95% CI 1.26 to 94.03; 53 participants, 1 study; very low-certainty evidence), and no data were available for the other outcomes of interest for this comparisonWe are also uncertain (very low-certainty evidence) whether exercise combined with education makes little or no difference to the number of falls (RaR 0.46, 95% CI 0.12 to 1.85; 320 participants, 2 studies), the number of people sustaining fall-related fractures (RR 1.45, 95% CI 0.40 to 5.32,320 participants, 2 studies), or health-related quality of life (PDQ39 MD 0.05, 95% CI -3.12 to 3.23, 305 participants, 2 studies). Exercise plus education may make little or no difference to the number of people experiencing one or more falls (RR 0.89, 95% CI 0.75 to 1.07; 352 participants, 3 studies; low-certainty evidence). We are uncertain whether exercise combined with education has an effect on adverse events or is a cost-effective intervention for fall prevention.\nAuthors' conclusions\nExercise interventions probably reduce the rate of falls, and probably slightly reduce the number of people falling in people with mild to moderate PD.\nCholinesterase inhibitors may reduce the rate of falls, but we are uncertain if they have an effect on the number of people falling. The decision to use these medications needs to be balanced against the risk of non fall-related adverse events, though these adverse events were predominantly mild or transient in nature.\nFurther research in the form of large, high-quality RCTs are required to determine the relative impact of different types of exercise and different levels of supervision on falls, and how this could be influenced by disease severity. Further work is also needed to increase the certainty of the effects of medication and further explore falls prevention education interventions both delivered alone and in combination with exercise.\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": "Twelve studies compared exercise with a control intervention not thought to reduce falls. Exercise probably reduces the number of falls by around 26%. Exercise probably slightly reduces the number of people experiencing one or more falls by around 10%. Exercise may slightly improve health-related quality of life immediately after the exercise program. However, we are uncertain if it reduces the number of fall-related fractures, if it has an effect on the number of adverse events or if it is a cost-effective intervention for fall prevention.\nThree studies compared a cholinesterase inhibitor (either rivastigmine or donepezil) with placebo medication (an inactive treatment) and found that this medication may reduce the rate of falls by around 50%. However, the effect of this medication on the number of people experiencing one or more falls, and on health-related quality of life was uncertain. Cholinesterase inhibitor medication may increase the number of non fall related adverse events by around 60%. There was no information about the cost-effectiveness of medication for fall prevention.\nOne study compared education alone and three studies compared exercise plus education with a control group. Exercise plus education may make little or no difference to the number of people experiencing one or more falls. However, we are uncertain of the effects of these interventions on the other fall and non-fall outcomes."
}
]
|
query-laysum | 4131 | [
{
"role": "user",
"content": "Abstract: Background\nMumps is an infectious disease caused by the mumps virus. Chinese physicians generally believe that Chinese medicinal herbs are effective in alleviating symptoms and reducing the duration of mumps. Herbalists tend to develop a treatment plan according to the individual's symptoms.\nObjectives\nTo evaluate the effectiveness and safety of Chinese medicinal herbs combined with routine treatments for mumps.\nSearch methods\nWe searched CENTRAL (2015, Issue 1), MEDLINE (1948 to January week 4, 2015), EMBASE (1974 to February 2015), CINAHL (1981 to February 2015), AMED (1985 to April 2014), the Chinese Biomedical Database (CBM) (1980 to February 2015), China National Knowledge Infrastructure (CNKI) (1979 to February 2015), VIP Information (1989 to February 2015), and relevant databases of ongoing trials.\nSelection criteria\nRandomised controlled trials (RCTs) of Chinese medicinal herbs for mumps (with or without complications).\nData collection and analysis\nTwo review authors independently evaluated trial quality and conducted data extraction. We contacted the trial authors for missing data regarding participant allocation. Some trials allocated participants according to the participants' admission sequence, making it a pseudo-random allocation. None of the trials concealed participants' allocation or used blinding.\nMain results\nWe did not identify any eligible trials for inclusion. We identified 108 studies that claimed to use random allocation. We excluded 104 studies because the allocation methods the authors had used were not actually randomised. We were unable to contact the trial authors of the remaining four studies. These trials require further evaluation and have been allocated to the 'Studies awaiting classification' section.\nAuthors' conclusions\nWe did not find any RCTs for or against Chinese herbal medicine used in the treatment of mumps. We hope more high-quality RCTs will be conducted in the future.\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": "Mumps (epidemic parotitis) is an infectious illness caused by the multiplication of the mumps virus in the upper respiratory tract. It can range from a mild upper respiratory disease to serious complications. Herbal medicines have been used in traditional Chinese medicine (TCM) as the main therapy to prevent and treat mumps for thousands of years. Many Chinese physicians believe that Chinese medicinal herbs are effective in treating mumps."
}
]
|
query-laysum | 4133 | [
{
"role": "user",
"content": "Abstract: Background\nAcute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes.\nThis an update of a review previously published in May 2004 and June 2010.\nObjectives\nThe aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed:\nDoes the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death?\nDoes the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention?\nIs the administration of HBOT safe in both the short and long term?\nSearch methods\nWe updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions.\nSelection criteria\nRandomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT.\nData collection and analysis\nThree authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach.\nMain results\nNo new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow-up, in general there is little information on the longer-term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence).\nIn general, HBOT was well-tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521).\nAuthors' conclusions\nFor people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review.\n\nGiven the provided abstract, please respond to the following query: \"Studies found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We first searched the literature in 2004 and most recently in September 2014, finding 6 studies in total. All studies included patients with heart attack and some also included patients with severe angina. The dose of hyperbaric oxygen was similar in most studies."
}
]
|
query-laysum | 4134 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are under way. This is an update of a Cochrane Review first published in 2008, which suggested that probiotics may not be an effective treatment for eczema but identified areas in which evidence was lacking.\nObjectives\nTo assess the effects of probiotics for treating patients of all ages with eczema.\nSearch methods\nWe updated our searches of the following databases to January 2017: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the Global Resource of Eczema Trials (GREAT) database, MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), and Latin American Caribbean Health Sciences Literature (LILACS). We searched five trials registers and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs). We also handsearched a number of conference proceedings. We updated the searches of the main databases in January 2018 and of trials registries in March 2018, but we have not yet incorporated these results into the review.\nSelection criteria\nRandomised controlled trials of probiotics (live orally ingested micro-organisms) compared with no treatment, placebo, or other active intervention with no probiotics for the treatment of eczema diagnosed by a doctor.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. We recorded adverse events from the included studies and from a separate adverse events search conducted for the first review. We formally assessed reporting bias by preparing funnel plots, and we performed trial sequential analysis for the first primary outcome - eczema symptoms at the end of active treatment.\nWe used GRADE to assess the quality of the evidence for each outcome (in italic font).\nMain results\nWe included 39 randomised controlled trials involving 2599 randomised participants. We included participants of either gender, aged from the first year of life through to 55 years (only six studies assessed adults), who had mild to severe eczema. Trials were undertaken in primary and secondary healthcare settings, mainly in Europe or Asia. Duration of treatment ranged from four weeks to six months, and duration of follow-up after end of treatment ranged from zero to 36 months. We selected no standard dose: researchers used a variety of doses and concentrations of probiotics. The probiotics used were bacteria of the Lactobacillus and Bifidobacteria species, which were taken alone or combined with other probiotics, and were given with or without prebiotics. Comparators were no treatment, placebo, and other treatments with no probiotics.\nFor all results described in this abstract, the comparator was no probiotics. Active treatment ranged from six weeks to three months for all of the following results, apart from the investigator-rated eczema severity outcome, for which the upper limit of active treatment was 16 weeks. With regard to score, the higher the score, the more severe were the symptoms. All key results reported in this abstract were measured at the end of active treatment, except for adverse events, which were measured during the active treatment period.\nProbiotics probably make little or no difference in participant- or parent-rated symptoms of eczema (13 trials; 754 participants): symptom severity on a scale from 0 to 20 was 0.44 points lower after probiotic treatment (95% confidence interval (CI) -1.22 to 0.33; moderate-quality evidence). Trial sequential analysis shows that target sample sizes of 258 and 456, which are necessary to demonstrate a minimum mean difference of -2 and -1.5, respectively, with 90% power, have been exceeded, suggesting that further trials with similar probiotic strains for this outcome at the end of active treatment may be futile.\nWe found no evidence suggesting that probiotics make a difference in QoL for patients with eczema (six studies; 552 participants; standardised mean difference (SMD) 0.03, 95% CI -0.36 to 0.42; low-quality evidence) when measured by the participant or the parent using validated disease-specific QoL instruments.\nProbiotics may slightly reduce investigator-rated eczema severity scores (24 trials; 1596 participants). On a scale of 0 to 103 for total Severity Scoring of Atopic Dermatitis (SCORAD), a score combining investigator-rated eczema severity score and participant scoring for eczema symptoms of itch and sleep loss was 3.91 points lower after probiotic treatment than after no probiotic treatment (95% CI -5.86 to -1.96; low-quality evidence). The minimum clinically important difference for SCORAD has been estimated to be 8.7 points.\nWe noted significant to extreme levels of unexplainable heterogeneity between the results of individual studies. We judged most studies to be at unclear risk of bias; six studies had high attrition bias, and nine were at low risk of bias overall.\nWe found no evidence to show that probiotics make a difference in the risk of adverse events during active treatment (risk ratio (RR) 1.54, 95% CI 0.90 to 2.63; seven trials; 402 participants; low-quality evidence). Studies in our review that reported adverse effects described gastrointestinal symptoms.\nAuthors' conclusions\nEvidence suggests that, compared with no probiotic, currently available probiotic strains probably make little or no difference in improving patient-rated eczema symptoms. Probiotics may make little or no difference in QoL for people with eczema nor in investigator-rated eczema severity score (combined with participant scoring for eczema symptoms of itch and sleep loss); for the latter, the observed effect was small and of uncertain clinical significance. Therefore, use of probiotics for the treatment of eczema is currently not evidence-based. This update found no evidence of increased adverse effects with probiotic use during studies, but a separate adverse events search from the first review revealed that probiotic treatment carries a small risk of adverse events.\nResults show significant, unexplainable heterogeneity between individual trial results. Only a small number of studies measured some outcomes.\nFuture studies should better measure QoL scores and adverse events, and should report on new probiotics. Researchers should also consider studying subgroups of patients (e.g. patients with atopy or food allergies, adults) and standardising doses/concentrations of probiotics given.\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 39 randomised controlled clinical trials (RCTs) with 2599 participants, which we identified in searches up to January 2017.\nThese studies included people of either gender and of all ages, although most studies assessed children who had been told by a healthcare professional that they had eczema. Participants had eczema ranging from mild to severe, and RCTs compared treatment with live micro-organisms (probiotics) of varying dose and concentration, taken by mouth, versus no treatment, placebo, or another treatment with no probiotics.\nThe probiotics included were bacteria of the Lactobacillus and Bifidobacteria species taken alone or in combination with other probiotics for a period ranging from four weeks up to six months. We did not look at studies that were seeking to prevent eczema. Most studies were done in Europe, and some were done in Asia, Australia, and New Zealand - all in a medical setting. Most studies were conducted at a single centre. Reviewers applied no language restrictions on study selection. Ten studies were funded by companies supplying the probiotics, and another four studies did not declare the source of funding."
}
]
|
query-laysum | 4135 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management usually depends upon what symptoms are acceptable to the individual. Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. Medical treatment options include oral medication and a hormone-releasing intrauterine device (LNG-IUS).\nObjectives\nTo compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.\nSearch methods\nWe searched the following databases from inception to January 2016: Cochrane Gynaecology and Fertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and clinical trials registers (clinical trials.gov and ICTRP). We also searched the reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials (RCTs) comparing conservative surgery or hysterectomy versus medical therapy (oral or intrauterine) for heavy menstrual bleeding.\nData collection and analysis\nTwo review authors independently selected the studies, assessed their risk of bias and extracted the data. Our primary outcomes were menstrual bleeding, satisfaction rate and adverse events. Where appropriate we pooled the data to calculate pooled risk ratios (RRs) or mean differences, with 95% confidence intervals (CIs), using a fixed-effect model. We assessed heterogeneity with the I2 statistic and evaluated the quality of the evidence using GRADE methods.\nMain results\nWe included 15 parallel-group RCTs (1289 women). Surgical interventions included hysterectomy and endometrial resection or ablation. Medical interventions included oral medication and the levonorgestrel-releasing intrauterine device (LNG-IUS). The overall quality of the evidence for different comparisons ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. Moreover, it was difficult to interpret long-term study findings as many women randomised to medical interventions subsequently underwent surgery.\nSurgery versus oral medication\nSurgery (endometrial resection) was more effective in controlling bleeding at four months (RR 2.66, 95% CI 1.94 to 3.64, one RCT, 186 women, moderate quality evidence) and also at two years (RR 1.29, 95% CI 1.06 to 1.57, one RCT, 173 women, low quality evidence). There was no evidence of a difference between the groups at five years (RR 1.14, 95% CI 0.97 to 1.34, one RCT, 140 women, very low quality evidence).\nSatisfaction with treatment was higher in the surgical group at two years (RR 1.40, 95% CI 1.13 to 1.74, one RCT, 173 women, moderate quality evidence), but there was no evidence of a difference between the groups at five years (RR 1.13, 95% CI 0.94 to 1.37, one RCT, 114 women, very low quality evidence). There were fewer adverse events in the surgical group at four months (RR 0.26, 95 CI 0.15 to 0.46, one RCT, 186 women). These findings require cautious interpretation, as 59% of women randomised to the oral medication group had had surgery within two years and 77% within five years.\nSurgery versus LNG-IUS\nWhen hysterectomy was compared with LNG-IUS, the hysterectomy group were more likely to have objective control of bleeding at one year (RR 1.11, 95% CI 1.05 to 1.19, one RCT, 223 women, moderate quality evidence). There was no evidence of a difference in quality of life between the groups at five or 10 years, but by 10 years 46% of women originally assigned to LNG-IUS had undergone hysterectomy. Adverse effects associated with hysterectomy included surgical complications such as bladder or bowel perforation and vesicovaginal fistula. Adverse effects associated with LNG-IUS were ongoing bleeding and hormonal symptoms.\nWhen conservative surgery was compared with LNG-IUS, at one year the surgical group were more likely to have subjective control of bleeding (RR 1.19, 95% CI 1.07 to 1.32, five RCTs, 281 women, low quality evidence, I2 = 15%). Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I2 = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups. There was no evidence of a difference between the groups in satisfaction rates at two years (RR 0.93, 95% CI 0.81 to 1.08, two RCTs, 117 women, I2 = 1%).\nAt one year there were fewer adverse events (such as bleeding and spotting) in the surgical group (RR 0.36, 95% CI 0.15 to 0.82, three RCTs, moderate quality evidence). It was unclear what proportion of women assigned to LNG-IUS underwent surgery over long-term follow-up, as there were few data beyond one year.\nAuthors' conclusions\nSurgery, especially hysterectomy, reduces menstrual bleeding more than medical treatment at one year. There is no conclusive evidence of a difference in satisfaction rates between surgery and LNG-IUS, though adverse effects such as bleeding and spotting are more likely to occur with LNG-IUS. Oral medication suits a minority of women in the long term, and the LNG-IUS device provides a better alternative to surgery in most cases. Although hysterectomy is a definitive treatment for heavy menstrual bleeding, it can cause serious complications for a minority of women. Most women may be well advised to try a less radical treatment as first-line therapy. Both LNG-IUS and conservative surgery appear to be safe, acceptable and effective.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. It was difficult to interpret study findings over long-term follow-up because a large number of women randomised to medical treatment subsequently underwent surgery."
}
]
|
query-laysum | 4136 | [
{
"role": "user",
"content": "Abstract: Background\nFor people who are malnourished and unable to consume food by mouth, nasoenteral feeding tubes are commonly used for the administration of liquid food and drugs. Postpyloric placement is when the tip of the feeding tube is placed beyond the pylorus, in the small intestine. Endoscopic-guided placement of postpyloric feeding tubes is the most common approach. Usually, an endoscopist and two or more medical professionals perform this procedure using a guidewire technique. The position of the tube is then confirmed with fluoroscopy or radiography, which requires moving people undergoing the procedure to the radiology department. Alternatively, electromagnetic-guided placement of postpyloric nasoenteral feeding tubes can be performed by a single trained nurse, at the bedside and with less equipment than endoscopic-guided placement. Hence, electromagnetic-guided placement may represent a promising alternative to endoscopic-guided placement, especially in settings where endoscopy and radiographic facilities are unavailable or difficult to access.\nObjectives\nTo assess the efficacy and safety of electromagnetic-guided placement of postpyloric nasoenteral feeding tubes compared to endoscopic-guided placement.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and OpenGrey until February 2021. We screened the reference lists of relevant review articles and current treatment guidelines for further literature. We contacted the study authors for missing data.\nSelection criteria\nWe included randomised trials comparing electromagnetic-guided placement with endoscopic-guided placement of nasoenteral feeding tubes. We excluded prospective cohort studies, retrospective cohort studies, (nested) case-control studies, cross-sectional studies, and case series or case reports.\nData collection and analysis\nTwo review authors independently assessed the methodological quality of potentially eligible trials and extracted data from the included trials. The primary outcomes were technical success in insertion and aspiration pneumonitis. The secondary outcomes were the time for postpyloric placement of nasoenteral feeding tubes, direct healthcare costs, and adverse events. We performed a random-effects meta-analysis. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MDs) with 95% CIs for continuous outcomes. We evaluated the certainty of evidence based on the GRADE approach.\nMain results\nWe identified four randomised controlled trials with 541 participants which met our inclusion criteria. All trials had methodological limitations, and lack of blinding of participants and investigators was a major source of bias. We had 'some concerns' for the overall risk of bias in all trials.\nElectromagnetic-guided postpyloric placement of nasoenteral feeding tubes may result in little to no difference in technical success in insertion compared to endoscopic-guided placement (RR 1.09, 95% CI 0.88 to 1.35; I2 = 81%; low-certainty evidence). Electromagnetic-guided placement may result in a difference in the proportion of participants with aspiration pneumonitis compared to endoscopic-guided placement, but these results are unclear (RR 0.24, 95% CI 0.03 to 2.18; I2 = 0%; low-certainty evidence). Electromagnetic-guided placement may result in little to no difference in the time for postpyloric placement of nasoenteral feeding tubes compared to endoscopic-guided placement (MD 4.06 minutes, 95% CI -0.47 to 8.59; I2 = 97%; low-certainty evidence). Electromagnetic-guided placement likely reduces direct healthcare costs compared to endoscopic-guided placement (MD -127.69 US dollars, 95% CI -135.71 to -119.67; moderate-certainty evidence). Electromagnetic-guided placement likely results in little to no difference in adverse events compared with endoscopic-guided placement (RR 0.78, 95% CI 0.41 to 1.49; moderate-certainty evidence).\nAuthors' conclusions\nWe found low-certainty evidence that electromagnetic-guided placement at the bedside results in little to no difference in technical success in insertion and aspiration pneumonitis, compared to endoscopic-guided placement. The heterogeneity of the healthcare professionals who performed the procedures and the small sample sizes limited our confidence in the evidence. Future research should be based on large studies with well-defined endpoints to potentially elucidate the differences between these two procedures.\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 four studies involving 541 participants that compared electromagnetic-guided placement with endoscopic-guided placement of feeding tubes through the nose. CORPAK MedSystems - a medical device company that specialises in tube feeding technology - funded two of the four studies, but it had no role in study design, data collection, data analysis, data interpretation, or writing of the study reports."
}
]
|
query-laysum | 4137 | [
{
"role": "user",
"content": "Abstract: Background\nRebleeding is an important cause of death and disability in people with aneurysmal subarachnoid haemorrhage. Rebleeding is probably related to the dissolution of the blood clot at the site of the aneurysm rupture by natural fibrinolytic activity. This review is an update of previously published Cochrane Reviews.\nObjectives\nTo assess the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2022), CENTRAL (in the Cochrane Library 2021, Issue 1), MEDLINE (December 2012 to May 2022), and Embase (December 2012 to May 2022). In an effort to identify further published, unpublished, and ongoing studies, we searched reference lists and trial registers, performed forward tracking of relevant references, and contacted drug companies (the latter in previous versions of this review).\nSelection criteria\nRandomised trials comparing oral or intravenous antifibrinolytic drugs (tranexamic acid, epsilon amino-caproic acid, or an equivalent) with control in people with subarachnoid haemorrhage of suspected or proven aneurysmal cause.\nData collection and analysis\nTwo review authors (MRG & WJD) independently selected trials for inclusion, and extracted the data for the current update. In total, three review authors (MIB & MRG in the previous update; MRG & WJD in the current update) assessed risk of bias. For the primary outcome, we dichotomised the outcome scales into good and poor outcome, with poor outcome defined as death, vegetative state, or (moderate) severe disability, assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale. We assessed death from any cause, rates of rebleeding, delayed cerebral ischaemia, and hydrocephalus per treatment group. We expressed effects as risk ratios (RR) with 95% confidence intervals (CI). We used random-effects models for all analyses. We assessed the quality of the evidence with GRADE.\nMain results\nWe included one new trial in this update, for a total of 11 included trials involving 2717 participants. The risk of bias was low in six studies. Five studies were open label, and we rated them at high risk of performance bias. We also rated one of these studies at high risk for attrition and reporting bias.\nFive trials reported on poor outcome (death, vegetative state, or (moderate) severe disability), with a pooled risk ratio (RR) of 1.03 (95% confidence interval (CI) 0.94 to 1.13; P = 0.53; 5 trials, 2359 participants; high-quality evidence), which showed no difference between groups. All trials reported on death from all causes, which showed no difference between groups, with a pooled RR of 1.02 (95% CI 0.90 to 1.16; P = 0.77; 11 trials, 2717 participants; high-quality evidence). In trials that combined short-term antifibrinolytic treatment (< 72 hours) with preventative measures for delayed cerebral ischaemia, the RR for poor outcome was 0.98 (95% CI 0.81 to 1.18; P = 0.83; 2 trials, 1318 participants; high-quality evidence).\nAntifibrinolytic treatment reduced the risk of rebleeding, reported at the end of follow-up (RR 0.65, 95% CI 0.47 to 0.91; P = 0.01; 11 trials, 2717 participants; absolute risk reduction 7%, 95% CI 3 to 12%; moderate-quality evidence), but there was heterogeneity (I² = 59%) between the trials. The pooled RR for delayed cerebral ischaemia was 1.27 (95% CI 1.00 to 1.62; P = 0.05; 7 trials, 2484 participants; moderate-quality evidence). However, this effect was less extreme after the implementation of ischaemia preventative measures and < 72 hours of treatment (RR 1.10, 95% CI 0.83 to 1.46; P = 0.49; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment showed no effect on the reported rate of hydrocephalus (RR 1.09, 95% CI 0.99 to 1.20; P = 0.09; 6 trials, 1992 participants; high-quality evidence).\nAuthors' conclusions\nThe current evidence does not support the routine use of antifibrinolytic drugs in the treatment of people with aneurysmal subarachnoid haemorrhage. More specifically, early administration with concomitant treatment strategies to prevent delayed cerebral ischaemia does not improve clinical outcome. There is sufficient evidence from multiple randomised controlled trials to incorporate this conclusion in treatment guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Antifibrinolytic treatment reduces the risk of rebleeding, but does not improve overall survival, or the chance of being independent in everyday activities. We conclude that there is no evidence to support routinely giving antifibrinolytic treatment to people with a subarachnoid haemorrhage caused by a ruptured aneurysm."
}
]
|
query-laysum | 4138 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the third updated version of a Cochrane review first published in Issue 4, 2003 of The Cochrane Library and first updated in 2007. Morphine has been used for many years to relieve pain. Oral morphine in either immediate release or modified release form remains the analgesic of choice for moderate or severe cancer pain.\nObjectives\nTo determine the efficacy of oral morphine in relieving cancer pain, and to assess the incidence and severity of adverse events.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9); MEDLINE (1966 to October 2015); and EMBASE (1974 to October 2015). We also searched ClinicalTrials.gov (1 October 2015).\nSelection criteria\nPublished randomised controlled trials (RCTs) using placebo or active comparators reporting on the analgesic effect of oral morphine in adults and children with cancer pain. We excluded trials with fewer than 10 participants.\nData collection and analysis\nOne review author extracted data, which were checked by another review author. There were insufficient comparable data for meta-analysis to be undertaken or to produce numbers needed to treat (NNTs) for the analgesic effect. We extracted any available data on the number or proportion of participants with 'no worse than mild pain' or treatment success (very satisfied, or very good or excellent on patient global impression scales).\nMain results\nWe identified seven new studies in this update. We excluded six, and one study is ongoing so also not included in this update. This review contains a total of 62 included studies, with 4241 participants. Thirty-six studies used a cross-over design ranging from one to 15 days, with the greatest number (11) for seven days for each arm of the trial. Overall we judged the included studies to be at high risk of bias because the methods of randomisation and allocation concealment were poorly reported. The primary outcomes for this review were participant-reported pain and pain relief.\nFifteen studies compared oral morphine modified release (Mm/r) preparations with morphine immediate release (MIR). Fourteen studies compared Mm/r in different strengths; six of these included 24-hour modified release products. Fifteen studies compared Mm/r with other opioids. Six studies compared MIR with other opioids. Two studies compared oral Mm/r with rectal Mm/r. Three studies compared MIR with MIR by a different route of administration. Two studies compared Mm/r with Mm/r at different times and two compared MIR with MIR given at a different time. One study was found comparing each of the following: Mm/r tablet with Mm/r suspension; Mm/r with non-opioids; MIR with non-opioids; and oral morphine with epidural morphine.\nIn the previous update, a standard of 'no worse than mild pain' was set, equivalent to a score of 30/100 mm or less on a visual analogue pain intensity scale (VAS), or the equivalent in other pain scales. Eighteen studies achieved this level of pain relief on average, and no study reported that good levels of pain relief were not attained. Where results were reported for individual participants in 17 studies, 'no worse than mild pain' was achieved by 96% of participants (362/377), and an outcome equivalent to treatment success in 63% (400/638).\nMorphine is an effective analgesic for cancer pain. Pain relief did not differ between Mm/r and MIR. Modified release versions of morphine were effective for 12- or 24-hour dosing depending on the formulation. Daily doses in studies ranged from 25 mg to 2000 mg with an average of between 100 mg and 250 mg. Dose titration was undertaken with both instant release and modified release products. A small number of participants did not achieve adequate analgesia with morphine. Adverse events were common, predictable, and approximately 6% of participants discontinued treatment with morphine because of intolerable adverse events.\nThe quality of the evidence is generally poor. Studies are old, often small, and were largely carried out for registration purposes and therefore were only designed to show equivalence between different formulations.\nAuthors' conclusions\nThe conclusions have not changed for this update. The effectiveness of oral morphine has stood the test of time, but the randomised trial literature for morphine is small given the importance of this medicine. Most trials recruited fewer than 100 participants and did not provide appropriate data for meta-analysis. Only a few reported how many people had good pain relief, but where it was reported, over 90% had no worse than mild pain within a reasonably short time period. The review demonstrates the wide dose range of morphine used in studies, and that a small percentage of participants are unable to tolerate oral morphine. The review also shows the wide range of study designs, and inconsistency in cross-over designs. Trial design was frequently based on titration of morphine or comparator to achieve adequate analgesia, then crossing participants over in cross-over design studies. It was not clear if these trials were sufficiently powered to detect any clinical differences between formulations or comparator drugs. New studies added to the review for the previous update reinforced the view that it is possible to use modified release morphine to titrate to analgesic effect. There is qualitative evidence that oral morphine has much the same efficacy as other available opioids.\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": "At one level these are good results. On another level, the quality of studies is generally poor and we could wish for more consistency in study design, and especially in study reporting, which should include the outcome of pain reduced to tolerable levels – no worse than mild pain – so that people with cancer are not bothered by pain."
}
]
|
query-laysum | 4139 | [
{
"role": "user",
"content": "Abstract: Background\nAggression is a disposition, a willingness to inflict harm, regardless of whether this is behaviourally or verbally expressed and regardless of whether physical harm is sustained.\nDe-escalation is a psychosocial intervention for managing people with disturbed or aggressive behaviour. Secondary management strategies such as rapid tranquillisation, physical intervention and seclusion should only be considered once de-escalation and other strategies have failed to calm the service user.\nObjectives\nTo investigate the effects of de-escalation techniques in the short-term management of aggression or agitation thought or likely to be due to psychosis.\nSearch methods\nWe searched Cochrane Schizophrenia Group's Study-Based Register of Trials (latest search 7 April, 2016).\nSelection criteria\nRandomised controlled trials using de-escalation techniques for the short-term management of aggressive or agitated behaviour. We planned to include trials involving adults (at least 18 years) with a potential for aggressive behaviour due to psychosis, from those in a psychiatric setting to those possibly under the influence of alcohol or drugs and/or as part of an acute setting as well. We planned to include trials meeting our inclusion criteria that provided useful data.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Two review authors inspected all abstracts of studies identified by the search process. As we were unable to include any studies, we could not perform data extraction and analysis.\nMain results\nOf the 345 citations that were identified using the search strategies, we found only one reference to be potentially suitable for further inspection. However, after viewing the full text, it was excluded as it was not a randomised controlled trial.\nAuthors' conclusions\nUsing de-escalation techniques for people with psychosis induced aggression or agitation appears to be accepted as good clinical practice but is not supported by evidence from randomised trials. It is unclear why it has remained such an under-researched area. Conducting trials in this area could be influenced by funding flow, ethical concerns - justified or not - anticipated pace of recruitment as well the difficulty in accurately quantifying the effects of de-escalation itself. With supportive funders and ethics committees, imaginative trialists, clinicians and service-user groups and wide collaboration this dearth of randomised research could be addressed.\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": "It is unclear why there are no randomised trials. Several issues such as cost, ethical considerations, difficulty recruiting people into trials, as well the ability to accurately quantify the effects of de-escalation itself could all be contributing factors. Meanwhile, de-escalation techniques are currently used without any trial-based evidence that they are effective."
}
]
|
query-laysum | 4140 | [
{
"role": "user",
"content": "Abstract: Background\nAtopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs).\nObjectives\nTo assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments.\nSearch methods\nWe searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database). We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials. We contacted specialists in the field for unpublished data.\nA separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013. We also scrutinised the U.S. Food and Drug Administration (FDA) websites for adverse effects information.\nSelection criteria\nAll randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments.\nData collection and analysis\nTwo authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction. Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects. Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as SCORAD (SCORing Atopic Dermatitis), the EASI (Eczema Area and Severity Index), and BSA (Body Surface Area) scores.\nMain results\nWe included 20 studies, with 5885 participants. The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses.\nA single trial showed that tacrolimus 0.1% was better than low-potency TCS by the physician's assessment (risk ratio (RR) 3.09, 95% confidence interval (CI) 2.14 to 4.45, 1 study, n = 371, moderate-quality evidence). It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 1.32, 95% CI 1.17 to 1.49, 1 study, n = 972, moderate level of evidence) and for some of the secondary outcomes. Compared with pimecrolimus 1%, people treated with tacrolimus were almost twice as likely to improve by the physician's assessment (RR 1.80, 95% CI 1.34 to 2.42, 2 studies, n = 506, moderate quality of evidence). Compared with the lower concentration of 0.03%, the tacrolimus 0.1% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 0.82, 95% CI 0.72 to 0.92, 6 studies, n = 1640, high-quality evidence). Tacrolimus 0.1% compared with moderate-to-potent TCS showed no difference by the physician's assessment, and 2 secondary outcomes (1 study, 377 participants) and a marginal benefit favouring tacrolimus 0.1% was found by the participant's assessment (RR 1.21, 95% CI 1.13 to 1.29, 1 study, n = 974, low quality of evidence) and SCORAD.\nBased on data from 2 trials, tacrolimus 0.03% was superior to mild TCS for the physician's assessment (RR 2.58, 95% CI 1.96 to 3.38, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 1.64, 95% CI 1.41 to 1.90, 1 study, n = 416, moderate quality of evidence). One trial showed moderate benefit of tacrolimus 0.03% compared with pimecrolimus 1% on the physician's assessment (RR 1.42, 95% CI 1.02 to 1.98, 1 study, n = 139, low-quality evidence), but the effects were equivocal when evaluating BSA. In the comparison of tacrolimus 0.03% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes), but in two studies, a marginal benefit favouring the corticosteroid group was found for the EASI and BSA scores.\nBurning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 0.03% (RR 2.48, 95% CI 1.96 to 3.14, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections. Symptoms observed were mild and transient. The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects.\nSerious adverse events were rare; occurred in both the tacrolimus and corticosteroid groups; and in most cases, were considered to be unrelated to the treatment. No cases of lymphoma were noted in the included studies nor in the non-comparative studies. Cases were only noted in spontaneous reports, cohorts, and case-control studies. Systemic absorption was rarely detectable, only in low levels, and this decreased with time. Exception is made for diseases with severe barrier defects, such as Netherton's syndrome, lamellar ichthyosis, and a few others, with case reports of a higher absorption. We evaluated clinical trials; case reports; and in vivo, in vitro, and animal studies; and didn't find any evidence that topical tacrolimus could cause skin atrophy.\nAuthors' conclusions\nTacrolimus 0.1% was better than low-potency corticosteroids, pimecrolimus 1%, and tacrolimus 0.03%. Results were equivocal when comparing both dose formulations to moderate-to-potent corticosteroids. Tacrolimus 0.03% was superior to mild corticosteroids and pimecrolimus. Both tacrolimus formulations seemed to be safe, and no evidence was found to support the possible increased risk of malignancies or skin atrophy with their use. The reliability and strength of the evidence was limited by the lack of data; thus, findings of this review should be interpreted with caution. We did not evaluate costs.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The variability of drug doses, results, and follow-up periods made it difficult to combine the results. The lack of data limited the reliability and strength of the evidence; thus, findings of this review should be interpreted with caution."
}
]
|
query-laysum | 4141 | [
{
"role": "user",
"content": "Abstract: Background\nThe treatment of people with acute abdominal pain differs if they have acute pancreatitis. It is important to know the diagnostic accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis, so that an informed decision can be made as to whether the person with abdominal pain has acute pancreatitis. There is currently no Cochrane review of the diagnostic test accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis.\nObjectives\nTo compare the diagnostic accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase, either alone or in combination, in the diagnosis of acute pancreatitis in people with acute onset of a persistent, severe epigastric pain or diffuse abdominal pain.\nSearch methods\nWe searched MEDLINE, Embase, Science Citation Index Expanded, National Institute for Health Research (NIHR HTA and DARE), and other databases until March 2017. We searched the references of the included studies to identify additional studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively. We also performed a 'related search' and 'citing reference' search in MEDLINE and Embase.\nSelection criteria\nWe included all studies that evaluated the diagnostic test accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis. We excluded case-control studies because these studies are prone to bias. We accepted any of the following reference standards: biopsy, consensus conference definition, radiological features of acute pancreatitis, diagnosis of acute pancreatitis during laparotomy or autopsy, and organ failure. At least two review authors independently searched and screened the references located by the search to identify relevant studies.\nData collection and analysis\nTwo review authors independently extracted data from the included studies. The thresholds used for the diagnosis of acute pancreatitis varied in the trials, resulting in sparse data for each index test. Because of sparse data, we used -2 log likelihood values to determine which model to use for meta-analysis. We calculated and reported the sensitivity, specificity, post-test probability of a positive and negative index test along with 95% confidence interval (CI) for each cutoff, but have reported only the results of the recommended cutoff of three times normal for serum amylase and serum lipase, and the manufacturer-recommended cutoff of 50 mg/mL for urinary trypsinogen-2 in the abstract.\nMain results\nTen studies including 5056 participants met the inclusion criteria for this review and assessed the diagnostic accuracy of the index tests in people presenting to the emergency department with acute abdominal pain. The risk of bias was unclear or high for all of the included studies. The study that contributed approximately two-thirds of the participants included in this review was excluded from the results of the analysis presented below due to major concerns about the participants included in the study. We have presented only the results where at least two studies were included in the analysis.\nSerum amylase, serum lipase, and urinary trypsinogen-2 at the standard threshold levels of more than three times normal for serum amylase and serum lipase, and a threshold of 50 ng/mL for urinary trypsinogen-2 appear to have similar sensitivities (0.72 (95% CI 0.59 to 0.82); 0.79 (95% CI 0.54 to 0.92); and 0.72 (95% CI 0.56 to 0.84), respectively) and specificities (0.93 (95% CI 0.66 to 0.99); 0.89 (95% CI 0.46 to 0.99); and 0.90 (95% CI 0.85 to 0.93), respectively). At the median prevalence of 22.6% of acute pancreatitis in the studies, out of 100 people with positive test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 74 (95% CI 33 to 94); 68 (95% CI 21 to 94); and 67 (95% CI 57 to 76) people have acute pancreatitis, respectively; out of 100 people with negative test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 8 (95% CI 5 to 12); 7 (95% CI 3 to 15); and 8 (95% CI 5 to 13) people have acute pancreatitis, respectively. We were not able to compare these tests formally because of sparse data.\nAuthors' conclusions\nAs about a quarter of people with acute pancreatitis fail to be diagnosed as having acute pancreatitis with the evaluated tests, one should have a low threshold to admit the patient and treat them for acute pancreatitis if the symptoms are suggestive of acute pancreatitis, even if these tests are normal. About 1 in 10 patients without acute pancreatitis may be wrongly diagnosed as having acute pancreatitis with these tests, therefore it is important to consider other conditions that require urgent surgical intervention, such as perforated viscus, even if these tests are abnormal.\nThe diagnostic performance of these tests decreases even further with the progression of time, and one should have an even lower threshold to perform additional investigations if the symptoms are suggestive of acute pancreatitis.\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 identified 10 studies reporting information on 5056 people with abdominal pain that started suddenly. The studies included pancreatitis due to all causes."
}
]
|
query-laysum | 4142 | [
{
"role": "user",
"content": "Abstract: Background\nLaparoscopy is a common procedure in many surgical specialties. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life-threatening complications include injury to viscera (e.g. bowel, bladder) or to vasculature (e.g. major abdominal and anterior abdominal wall vessels). No clear consensus has been reached as to the optimal method of laparoscopic entry into the peritoneal cavity.\nObjectives\nTo evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, and trials registers in January 2018. We also checked the references of articles retrieved.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared one laparoscopic entry technique versus another. Primary outcomes were major complications including mortality, vascular injury of major vessels and abdominal wall vessels, visceral injury of bladder or bowel, gas embolism, solid organ injury, and failed entry (inability to access the peritoneal cavity). Secondary outcomes were extraperitoneal insufflation, trocar site bleeding, trocar site infection, incisional hernia, omentum injury, and uterine bleeding.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods.\nMain results\nThe review included 57 RCTs including four multi-arm trials, with a total of 9865 participants, and evaluated 25 different laparoscopic entry techniques. Most studies selected low-risk patients, and many studies excluded patients with high body mass index (BMI) and previous abdominal surgery. Researchers did not find evidence of differences in major vascular or visceral complications, as would be anticipated given that event rates were very low and sample sizes were far too small to identify plausible differences in rare but serious adverse events.\nOpen-entry versus closed-entry\nTen RCTs investigating Veress needle entry reported vascular injury as an outcome. There was a total of 1086 participants and 10 events of vascular injury were reported. Four RCTs looking at open entry technique reported vascular injury as an outcome. There was a total of 376 participants and 0 events of vascular injury were reported. This was not a direct comparison. In the direct comparison of Veress needle and Open-entry technique, there was insufficient evidence to determine whether there was a difference in rates of vascular injury (Peto OR 0.14, 95% CI 0.00 to 6.82; 4 RCTs; n = 915; I² = N/A, very low-quality evidence). Evidence was insufficient to show whether there were differences between groups for visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08; 4 RCTs; n = 915: I² = 0%; very low-quality evidence), or failed entry (Peto OR 0.45, 95% CI 0.14 to 1.42; 3 RCTs; n = 865; I² = 63%; very low-quality evidence). Two studies reported mortality with no events in either group. No studies reported gas embolism or solid organ injury.\nDirect trocar versus Veress needle entry\nTrial results show a reduction in failed entry into the abdomen with the use of a direct trocar in comparison with Veress needle entry (OR 0.24, 95% CI 0.17 to 0.34; 8 RCTs; N = 3185; I² = 45%; moderate-quality evidence). Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.59, 95% CI 0.18 to 1.96; 6 RCTs; n = 1603; I² = 75%; very low-quality evidence), visceral injury (Peto OR 2.02, 95% CI 0.21 to 19.42; 5 RCTs; n = 1519; I² = 25%; very low-quality evidence), or solid organ injury (Peto OR 0.58, 95% Cl 0.06 to 5.65; 3 RCTs; n = 1079; I² = 61%; very low-quality evidence). Four studies reported mortality with no events in either group. Two studies reported gas embolism, with no events in either group.\nDirect vision entry versus Veress needle entry\nEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.39, 95% CI 0.05 to 2.85; 1 RCT; n = 186; very low-quality evidence) or visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34; 2 RCTs; n = 380; I² = N/A; very low-quality evidence). Trials did not report our other primary outcomes.\nDirect vision entry versus open entry\nEvidence was insufficient to show whether there were differences between groups in rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50; 2 RCTs; n = 392; I² = N/A; very low-quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67; 1 RCT; n = 60; very low-quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09; 1 RCT; n = 60; very low-quality evidence). Two studies reported vascular injury with no events in either arm. Trials did not report our other primary outcomes.\nRadially expanding (STEP) trocars versus non-expanding trocars\nEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21; 2 RCTs; n = 331; I² = 0%; very low-quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37; 2 RCTs; n = 331; very low-quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91; 1 RCT; n = 244; very low-quality evidence). Trials did not report our other primary outcomes.\nOther studies compared a wide variety of other laparoscopic entry techniques, but all evidence was of very low quality and evidence was insufficient to support the use of one technique over another.\nAuthors' conclusions\nOverall, evidence was insufficient to support the use of one laparoscopic entry technique over another. Researchers noted an advantage of direct trocar entry over Veress needle entry for failed entry. Most evidence was of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane review authors evaluated the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery."
}
]
|
query-laysum | 4143 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a malignancy of plasma cells accounting for approximately 1% of cancers and 12% of haematological malignancies. The first-in-class proteasome inhibitor, bortezomib, is commonly used to treat newly diagnosed as well as relapsed/refractory myeloma, either as single agent or combined with other therapies.\nObjectives\nWe conducted a systematic review and meta-analysis to assess the effects of bortezomib on overall survival (OS), progression-free survival (PFS), response rate (RR), health-related quality of life (HRQoL), adverse events (AEs) and treatment-related death (TRD).\nSearch methods\nWe searched MEDLINE, the Cochrane Central Register of Controlled Trials and EMBASE (till 27 January 2016) as well as conference proceedings and clinical trial registries for randomised controlled trials (RCTs).\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared i) bortezomib versus no bortezomib with the same background therapy in each arm; ii) bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s) and iii) bortezomib dose comparisons and comparisons of different treatment administrations and schedules.\nData collection and analysis\nTwo review authors independently extracted outcomes data and assessed risk of bias. We extracted hazard ratios (HR) and their confidence intervals for OS and PFS and odds ratios (OR) for response rates, AEs and TRD. We contacted trial authors to provide summary statistics if missing. We estimated Logrank statistics which were not available. We extracted HRQoL data, where available.\nMain results\nWe screened a total of 3667 records, identifying 16 relevant RCTs involving 5626 patients and included 12 trials in the meta-analyses. All trials were randomised and open-label studies. Two trials were published in abstract form and therefore we were unable to assess potential risk of bias in full.\nThere is moderate-quality evidence that bortezomib prolongs OS (four studies, 1586 patients; Peto OR 0.77, 95% CI 0.65 to 0.92) and PFS (five studies, 1855 patients; Peto OR 0.65, 95% CI 0.57 to 0.74) from analysing trials of bortezomib versus no bortezomib with the same background therapy in each arm.\nThere is high-quality evidence that bortezomib prolongs OS (five studies, 2532 patients; Peto OR 0.76, 95% CI 0.67 to 0.88) but low-quality evidence for PFS (four studies, 2489 patients; Peto OR 0.67, 95% CI 0.61 to 0.75) from analysing trials of bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s).\nFour trials (N = 716) examined different doses, methods of administrations and treatment schedules and were reviewed qualitatively only.\nWe identified four trials in the meta-analysis that measured time to progression (TTP) and were able to extract and analyse PFS data for three of the studies, while in the case of one study, we included TTP data as PFS data were not available. We therefore did not analyse TTP separately in this review.\nPatients treated with bortezomib have increased risk of thrombocytopenia, neutropenia, gastro-intestinal toxicities, peripheral neuropathy, infection and fatigue with the quality of evidence highly variable. There is high-quality evidence for increased risk of cardiac disorders from analysing trials of bortezomib versus no bortezomib with different background therapy in each arm or versus other agents. The risk of TRD in either comparison group analysed is uncertain due to the low quality of the evidence.\nOnly four trials analysed HRQoL and the data could not be meta-analysed.\nSubgroup analyses by disease setting revealed improvements in all outcomes, whereas for therapy setting, an improved benefit for bortezomib was observed in all outcomes and subgroups except for OS following consolidation therapy.\nAuthors' conclusions\nThis meta-analysis found that myeloma patients receiving bortezomib benefited in terms of OS, PFS and response rate compared to those who did not receive bortezomib. This benefit was observed in trials of bortezomib versus no bortezomib with the same background therapy and in trials of bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s). Further evaluation of newer proteasome inhibitors is required to ascertain whether these agents offer an improved risk-benefit profile, while more studies of HRQoL are also required.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 16 studies involving 5626 myeloma patients. The results of this review suggest that bortezomib can lead to better survival, a longer time without progression and better response rates compared to those not receiving bortezomib. Treatment with bortezomib causes a number of side effects including: low levels of some blood cells; gastro-intestinal effects such as constipation, diarrhoea, nausea and vomiting; nerve pain and tingling in hands and feet, as well as infection. A greater risk of heart problems was seen in one of the comparison groups studied. Risk of death from bortezomib treatment was uncertain in either group analysed. Only four studies assessed quality of life and could not be analysed together."
}
]
|
query-laysum | 4144 | [
{
"role": "user",
"content": "Abstract: Background\nJumping from a height is an uncommon but lethal means of suicide. Restricting access to means is an important universal or population-based approach to suicide prevention with clear evidence of its effectiveness. However, the evidence with respect to means restriction for the prevention of suicide by jumping is not well established.\nObjectives\nTo evaluate the effectiveness of interventions to restrict the availability of, or access to, means of suicide by jumping. These include the use of physical barriers, fencing or safety nets at frequently-used jumping sites, or restriction of access to these sites, such as by way of road closures.\nSearch methods\nWe searched the Cochrane Library, Embase, MEDLINE, PsycINFO, and Web of Science to May 2019. We conducted additional searches of the international trial registries including the World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov, to identify relevant unpublished and ongoing studies. We searched the reference lists of all included studies and relevant systematic reviews to identify additional studies and contacted authors and subject experts for information on unpublished or ongoing studies. We applied no restrictions on date, language or publication status to the searches. Two review authors independently assessed all citations from the searches and identified relevant titles and abstracts. Our main outcomes of interest were suicide, attempted suicide or self-harm, and cost-effectiveness of interventions.\nSelection criteria\nEligible studies were randomised or quasi-randomised controlled trials, controlled intervention studies without randomisation, before-and-after studies, or studies using interrupted time series designs, which evaluated interventions to restrict the availability of, or access to, means of suicide by jumping.\nData collection and analysis\nTwo review authors independently selected studies for inclusion and three review authors extracted study data. We pooled studies that evaluated similar interventions and outcomes using a random-effects meta-analysis, and we synthesised data from other studies in a narrative summary. We summarised the quality of the evidence included in this review using the GRADE approach.\nMain results\nWe included 14 studies in this review. Thirteen were before-and-after studies and one was a cost-effectiveness analysis. Three studies each took place in Switzerland and the USA, while two studies each were from the UK, Canada, New Zealand, and Australia respectively. The majority of studies (10/14) assessed jumping means restriction interventions delivered in isolation, half of which were at bridges. Due to the observational nature of included studies, none compared comparator interventions or control conditions.\nDuring the pre- and postintervention period among the 13 before-and-after studies, a total of 742.3 suicides (5.5 suicides per year) occurred during the pre-intervention period (134.5 study years), while 70.6 suicides (0.8 suicides per year) occurred during the postintervention period (92.4 study years) - a 91% reduction in suicides. A meta-analysis of all studies assessing jumping means restriction interventions (delivered in isolation or in combination with other interventions) showed a directionality of effect in favour of the interventions, as evidenced by a reduction in the number of suicides at intervention sites (12 studies; incidence rate ratio (IRR) = 0.09, 95% confidence interval (CI) 0.03 to 0.27; P < 0.001; I2 = 88.40%). Similar findings were demonstrated for studies assessing jumping means restriction interventions delivered in isolation (9 studies; IRR = 0.05, 95% CI 0.01 to 0.16; P < 0.001; I2 = 73.67%), studies assessing jumping means restriction interventions delivered in combination with other interventions (3 studies; IRR = 0.54, 95% CI 0.31 to 0.93; P = 0.03; I2 = 40.8%), studies assessing the effectiveness of physical barriers (7 studies; IRR = 0.07, 95% CI 0.02 to 0.24; P < 0.001; I2 = 84.07%), and studies assessing the effectiveness of safety nets (2 studies; IRR = 0.09, 95% CI 0.01 to 1.30; P = 0.07; I2 = 29.3%). Data on suicide attempts were limited and none of the studies used self-harm as an outcome. There was considerable heterogeneity between studies for the primary outcome (suicide) in the majority of the analyses except those relating to jumping means restriction delivered in combination with other interventions, and safety nets. Nevertheless, every study included in the forest plots showed the same directional effects in favour of jumping means restriction. Due to methodological limitations of the included studies, we rated the quality of the evidence from these studies as low.\nA cost-effectiveness analysis suggested that the construction of a physical barrier on a bridge would be a highly cost-effective project in the long term as a result of overall reduced suicide mortality.\nAuthors' conclusions\nThe findings from this review suggest that jumping means restriction interventions are capable of reducing the frequency of suicides by jumping. However, due to methodological limitations of included studies, this finding is based on low-quality evidence. Therefore, further well-designed high-quality studies are required to further evaluate the effectiveness of these interventions, as well as other measures at jumping sites. In addition, further research is required to investigate the potential for suicide method substitution and displacement effects in populations exposed to interventions to prevent suicide by jumping.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched several databases (the Cochrane Library, Embase, MEDLINE, PsycINFO, and Web of Science) to find studies that assessed the impact of restricting access to means of suicide by jumping. We searched the databases up until May 2019. We included studies that assessed jumping means restriction interventions delivered on their own, such as physical barriers, fencing or safety nets on bridges, or those delivered in combination with other suicide prevention interventions, such as crisis telephones and CCTV cameras. We also searched the reference lists of all included studies and relevant systematic reviews to identify additional studies and contacted authors to obtain missing information. Our main outcomes of interest were suicide, attempted suicide or self-harm and cost-effectiveness of interventions."
}
]
|
query-laysum | 4145 | [
{
"role": "user",
"content": "Abstract: Background\nInfective endocarditis is a severe infection arising in the lining of the chambers of the heart. It can be caused by fungi, but most often is caused by bacteria. Many dental procedures cause bacteraemia, which could lead to bacterial endocarditis in a small proportion of people. The incidence of bacterial endocarditis is low, but it has a high mortality rate.\nGuidelines in many countries have recommended that antibiotics be administered to people at high risk of endocarditis prior to invasive dental procedures. However, guidance by the National Institute for Health and Care Excellence (NICE) in England and Wales states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures. This is an update of a review that we first conducted in 2004 and last updated in 2013.\nObjectives\nPrimary objective\nTo determine whether prophylactic antibiotic administration, compared to no antibiotic administration or placebo, before invasive dental procedures in people at risk or at high risk of bacterial endocarditis, influences mortality, serious illness or the incidence of endocarditis.\nSecondary objectives\nTo determine whether the effect of dental antibiotic prophylaxis differs in people with different cardiac conditions predisposing them to increased risk of endocarditis, and in people undergoing different high risk dental procedures.\nHarms\nHad we foundno evidence from randomised controlled trials or cohort studies on whether prophylactic antibiotics affected mortality or serious illness, and we had found evidence from these or case-control studies suggesting that prophylaxis with antibiotics reduced the incidence of endocarditis, then we would also have assessed whether the harms of prophylaxis with single antibiotic doses, such as with penicillin (amoxicillin 2 g or 3 g) before invasive dental procedures, compared with no antibiotic or placebo, equalled the benefits in prevention of endocarditis in people at high risk of this disease.\nSearch methods\nAn information specialist searched four bibliographic databases up to 10 May 2021 and used additional search methods to identify published, unpublished and ongoing studies\nSelection criteria\nDue to the low incidence of bacterial endocarditis, we anticipated that few if any trials would be located. For this reason, we included cohort and case-control studies with suitably matched control or comparison groups. The intervention was antibiotic prophylaxis, compared to no antibiotic prophylaxis or placebo, before a dental procedure in people with an increased risk of bacterial endocarditis. Cohort studies would need to follow at-risk individuals and assess outcomes following any invasive dental procedures, grouping participants according to whether or not they had received prophylaxis. Case-control studies would need to match people who had developed endocarditis after undergoing an invasive dental procedure (and who were known to be at increased risk before undergoing the procedure) with those at similar risk who had not developed endocarditis.\nOur outcomes of interest were mortality or serious adverse events requiring hospital admission; development of endocarditis following any dental procedure in a defined time period; development of endocarditis due to other non-dental causes; any recorded adverse effects of the antibiotics; and the cost of antibiotic provision compared to that of caring for patients who developed endocarditis.\nData collection and analysis\nTwo review authors independently screened search records, selected studies for inclusion, assessed the risk of bias in the included study and extracted data from the included study. As an author team, we judged the certainty of the evidence identified for the main comparison and key outcomes using GRADE criteria. We presented the main results in a summary of findings table.\nMain results\nOur new search did not find any new studies for inclusion since the last version of the review in 2013.\nNo randomised controlled trials (RCTs), controlled clinical trials (CCTs) or cohort studies were included in the previous versions of the review, but one case-control study met the inclusion criteria. The trial authors collected information on 48 people who had contracted bacterial endocarditis over a specific two-year period and had undergone a medical or dental procedure with an indication for prophylaxis within the past 180 days. These people were matched to a similar group of people who had not contracted bacterial endocarditis. All study participants had undergone an invasive medical or dental procedure. The two groups were compared to establish whether those who had received preventive antibiotics (penicillin) were less likely to have developed endocarditis. The authors found no significant effect of penicillin prophylaxis on the incidence of endocarditis. No data on other outcomes were reported.\nThe level of certainty we have about the evidence is very low.\nAuthors' conclusions\nThere remains no clear evidence about whether antibiotic prophylaxis is effective or ineffective against bacterial endocarditis in at-risk people who are about to undergo an invasive dental procedure. We cannot determine whether the potential harms and costs of antibiotic administration outweigh any beneficial effect. Ethically, practitioners should discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Cochrane Review aimed to find out whether people with increased risk of bacterial endocarditis (a severe infection or inflammation of the lining of the heart chambers that can be fatal) should be given antibiotics routinely before invasive dental procedures to reduce the incidence of endocarditis, the number of deaths, and the amount of serious illness this group of people experiences."
}
]
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.