title: Rethinking the assessment of risk of bias due to selective reporting: a cross-sectional study.
abstract: Selective reporting is included as a core domain of Cochrane's tool for assessing risk of bias in randomised trials. There has been no evaluation of review authors' use of this domain. We aimed to evaluate assessments of selective reporting in a cross-section of Cochrane reviews and to outline areas for improvement.
  
  
  
  We obtained data on selective reporting judgements for 8434 studies included in 586 Cochrane reviews published from issue 1-8, 2015. One author classified the reasons for judgements of high risk of selective reporting bias. We randomly selected 100 reviews with at least one trial rated at high risk of outcome non-reporting bias (non-/partial reporting of an outcome on the basis of its results). One author recorded whether the authors of these reviews incorporated the selective reporting assessment when interpreting results.
  
  
  
  Of the 8434 studies, 1055 (13 %) were rated at high risk of bias on the selective reporting domain. The most common reason was concern about outcome non-reporting bias. Few studies were rated at high risk because of concerns about bias in selection of the reported result (e.g. reporting of only a subset of measurements, analysis methods or subsets of the data that were pre-specified). Review authors often specified in the risk of bias tables the study outcomes that were not reported (84 % of studies) but less frequently specified the outcomes that were partially reported (61 % of studies). At least one study was rated at high risk of outcome non-reporting bias in 31 % of reviews. In the random sample of these reviews, only 30 % incorporated this information when interpreting results, by acknowledging that the synthesis of an outcome was missing data that were not/partially reported.
  
  
  
  Our audit of user practice in Cochrane reviews suggests that the assessment of selective reporting in the current risk of bias tool does not work well. It is not always clear which outcomes were selectively reported or what the corresponding risk of bias is in the synthesis with missing outcome data. New tools that will make it easier for reviewers to convey this information are being developed.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. matthew.page@bristol.ac.uk.|School of Public Health and Preventive Medicine, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia. matthew.page@bristol.ac.uk.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Page
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
authors.forename: Julian P T
authors.initials: JP
authors.lastname: Higgins
mesh_terms: D003430:Cross-Sectional Studies; D006801:Humans; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D015983:Selection Bias
keywords: Bias; Methodology; Quality; Randomised trials; Systematic reviews