Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool.

Objective-To develop a short instrument, called DISCERN, which will enable patients and information providers to judge the quality of written information about treatment choices. DISCERN will also facilitate the production of new, high quality, evidence-based consumer health information. Design-An expert panel, representing a range of expertise in consumer health information, generated criteria from a random sample of information for three medical conditions with varying degrees of evidence: myocardial infarction, endometriosis, and chronic fatigue syndrome. A draft instrument, based on this analysis, was tested by the panel on a random sample of new material for the same three conditions. The panel re-drafted the instrument to take account of the results of the test. The DISCERN instrument was finally tested by a national sample of 15 information providers and 13 self help group members on a random sample of leaflets from 19 major national self help organisations. Participants also completed an 8 item questionnaire concerning the face and content validity of the instrument. Results-Chance corrected agreement (weighted ) for the overall quality rating was =0.53 (95% CI =0.48 to =0.59) among the expert panel, =0.40 (95% CI =0.36 to =0.43) among information providers, and =0.23 (95% CI =0.19 to =0.27) among self help group members. Higher agreement levels were associated with experience of using the instrument and with professional knowledge of consumer health information. Levels of agreement varied across individual items on the instrument, reflecting the need for subjectivity in rating certain criteria. The trends in levels of agreement were similar among all groups. The final instrument consisted of 15 questions plus an overall quality rating. Responses to the questionnaire after the final testing revealed the instrument to have good face and content validity and to be generally applicable. Conclusions-DISCERN is a reliable and valid instrument for judging the quality of written consumer health information. While some subjectivity is required for rating certain criteria, the findings demonstrate that the instrument can be applied by experienced users and providers of health information to discriminate between publications of high and low quality. The instrument will also be of benefit to patients, though its use will be improved by training.

Systematic reviews of health related interventions often use alternative methods of synthesis to meta-analysis of effect estimates, methods often described as "narrative synthesis" Serious shortcomings in reviews that use "narrative synthesis" have been identified, including a lack of description of the methods used; unclear links between the included data, the synthesis, and the conclusions; and inadequate reporting of the limitations of the synthesis The Synthesis Without Meta-analysis (SWiM) guideline is a nine item checklist to promote transparent reporting for reviews of interventions that use alternative synthesis methods The SWiM items prompt users to report how studies are grouped, the standardised metric used for the synthesis, the synthesis method, how data are presented, a summary of the synthesis findings, and limitations of the synthesis The SWiM guideline has been developed using a best practice approach, involving extensive consultation and formal consensus on 11 September 2020 by guest. Protected by copyright.

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BackgroundIndividuals with human immunodeficiency virus (HIV) infection are at an increased risk of developing active tuberculosis (TB). It is known that treatment of latent TB infection (LTBI), also referred to as TB preventive therapy or chemoprophylaxis, helps to prevent progression to active disease in HIV negative populations. However, the extent and magnitude of protection (if any) associated with preventive therapy in those infected with HIV should be quantified. This present study is an update of the original review. ObjectivesTo determine the e ectiveness of TB preventive therapy in reducing the risk of active tuberculosis and death in HIV-infected persons. Search methodsThis review was updated using the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, AIDSLINE, AIDSTRIALS, AIDSearch, NLM Gateway and AIDSDRUGS (publication date from 01 July 2002 to 04 April 2008). We also scanned reference lists of articles and contacted authors and other researchers in the field in an attempt to identify additional studies that may be eligible for inclusion in this review. Selection criteriaWe included randomized controlled trials in which HIV positive individuals were randomly allocated to TB preventive therapy or placebo, or to alternative TB preventive therapy regimens. Participants could be tuberculin skin test positive or negative, but without active tuberculosis. Data collection and analysisThree reviewers independently applied the study selection criteria, assessed study quality and extracted data. E ects were assessed using relative risk for dichotomous data and mean di erences for continuous data. Main results12 trials were included with a total of 8578 randomized participants. TB preventive therapy (any anti-TB drug) versus placebo was associated with a lower incidence of active TB (RR 0.68, 95% CI 0.54 to 0.85). This benefit was more pronounced in individuals with a positive tuberculin skin test (RR 0.38, 95% CI 0.25 to 0.57) than in those who had a negative test (RR 0.89, 95% CI 0.64 to 1.24). E icacy was similar for all regimens (regardless of drug type, frequency or duration of treatment). However, compared to INH monotherapy, shortcourse multi-drug regimens were much more likely to require discontinuation of treatment due to adverse e ects. Although there was reduction in mortality with INH monotherapy versus placebo among individuals with a positive tuberculin skin test (RR 0.74, 95% CI 0.55 to 1.00) and with INH plus rifampicin versus placebo regardless of tuberculin skin test status (RR 0.69, 95% CI 0.50 to 0.95), overall, there was no evidence that TB preventive therapy versus placebo reduced all-cause mortality (RR 0.94, 95% CI 0.85 to 1.05).