Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.
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ABSTRACT: Objective
To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews.Design
Cohort study of systematic reviews from two databases.Setting
Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events.Participants
92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort).Methods
A 13 point classification system for missing outcome data on harm was developed and applied to the studies.Results
86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393).Conclusions
The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews.
SUBMITTER: Saini P
PROVIDER: S-EPMC4240443 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Abstract This is the protocol for a Campbell systematic review. The objectives are as follows: To identify methods used to assess the risk of outcome reporting bias (ORB) in studies included in recent Campbell systematic reviews of intervention effects. The review will answer the following questions: What proportion of recent Campbell reviews included assessment of ORB? How did recent reviews define levels of risk of ORB (what categories, labels, and definitions did they use)? To what extent and how did these reviews use study protocols as sources of data on ORB? To what extent and how did reviews document reasons for judgments about risk of ORB? To what extent and how did reviews assess the inter‐rater reliability of ORB ratings? To what extent and how were issues of ORB considered in the review's abstract, plain language summary, and conclusions?
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Project description:Outcome reporting bias (ORB) in randomised trials has been identified as a threat to the validity of systematic reviews. Previous work highlighting this problem is limited to considering a single primary review outcome. The aim of this study was to assess ORB across all efficacy outcomes in the Cochrane systematic reviews of cystic fibrosis. Systematic reviews of interventions for cystic fibrosis published on the Cochrane Library by the Cochrane Cystic Fibrosis and Genetic Disorders Group before 2010 were assessed for discrepancies in outcomes between review protocol and full review. ORB in eligible trials was also assessed for all efficacy review outcomes. Two authors independently classified each outcome using a nine-point classification system developed by the Outcome Reporting Bias In Trials study. These classifications were used to inform the assessment of the risk of bias for selective outcome reporting for each trial. -46 Cochrane cystic fibrosis systematic reviews were included. The median number of primary outcomes, number of trials and participants per trial in the reviews were 3 (IQR 2, 3), 4 (IQR 2, 8) and 21 (IQR 14, 41), respectively. 18 reviews (39%, 18/46) had a discrepancy in outcomes between protocol and full review. 37 reviews were eligible to be included in the ORB assessment. When considering review primary outcomes and all review outcomes, ORB was suspected in at least one trial in 86% and 100%, respectively. Assessment of ORB within a systematic review of a single primary outcome underestimates the risk of ORB in comparison to the assessment of multiple primary and secondary outcomes. ORB in trials is highly prevalent within systematic reviews of cystic fibrosis when assessed across all outcomes. This could be reduced by the development of a core outcome set for trials and systematic reviews in cystic fibrosis.
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Project description:BackgroundDiscrepancies in outcome reporting (DOR) between protocol and published studies include inclusions of new outcomes, omission of prespecified outcomes, upgrade and downgrade of secondary and primary outcomes, and changes in definitions of prespecified outcomes. DOR can result in outcome reporting bias (ORB) when changes in outcomes occur after knowledge of results. This has potential to overestimate treatment effects and underestimate harms. This can also occur at the level of systematic reviews when changes in outcomes occur after knowledge of results of included studies. The prevalence of DOR and ORB in systematic reviews is unknown in systematic reviews published post-2007.ObjectiveTo estimate the prevalence of DOR and risk of ORB in all Cochrane reviews between the years 2007 and 2014.MethodsA stratified random sampling approach was applied to collect a representative sample of Cochrane systematic reviews from each Cochrane review group. DOR was assessed by matching outcomes in each systematic review with their respective protocol. When DOR occurred, reviews were further assessed if there was a risk of ORB (unclear, low or high risk). We classified DOR as a high risk for ORB if the discrepancy occurred after knowledge of results in the systematic review.Results150 of 350 (43%) review and protocol pairings contained DOR. When reviews were further scrutinised, 23% (35 of 150) of reviews with DOR contained a high risk of ORB, with changes being made after knowledge of results from individual trials.ConclusionsIn our study, we identified just under a half of Cochrane reviews with at least one DOR. Of these, a fifth were at high risk of ORB. The presence of DOR and ORB in Cochrane reviews is of great concern; however, a solution is relatively simple. Authors are encouraged to be transparent where outcomes change and to describe the legitimacy of changing outcomes in order to prevent suspicion of bias.
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Project description:IntroductionSelective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored.MethodsOur primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included.ResultsOf 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes.ConclusionOur results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making.
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Project description:BackgroundResearch articles tend to focus on positive findings in their abstract, especially if multiple outcomes have been studied. At the same time, search queries in databases are generally limited to the abstract, title and keywords fields of an article. Negative findings are therefore less likely to be detected by systematic searches and to appear in systematic reviews. We aim to assess the occurrence of this 'abstract reporting bias' and quantify its impact in the literature on the association between diesel exhaust exposure (DEE) and bladder cancer.MethodsWe set up a broad search query related to DEE and cancer in general. Full-texts of the articles identified in the search output were manually scanned. Articles were included if they reported, anywhere in the full-text, the association between DEE and bladder cancer. We assume that the use of a broad search query and manual full-text scanning allowed us to catch all the relevant articles, including those in which bladder cancer was not mentioned in the abstract, title or keywords.ResultsWe identified 28 articles. Only 12 of these (43%) had mentioned bladder in their abstract, title or keywords. A meta-analysis based on these 12 detectable articles yielded a pooled risk estimate of 1.10 (95% confidence interval [CI] 0.97-1.25), whereas the meta-analysis based on all 28 articles yielded a pooled estimate of 1.03 (95% CI 0.96-1.11).ConclusionsThis case study on abstract reporting bias shows that (a) more than half of all relevant articles were missed by a conventional search query and (b) this led to an overestimation of the pooled effect. Detection of articles will be improved if all studied exposure and outcome variables are reported in the keywords. The restriction on the maximum number of keywords should be lifted.
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Project description:Meta-analyses play an important role in synthesizing evidence from diverse studies and datasets that address similar questions. A major obstacle for meta-analyses arises from biases in reporting. In particular, it is speculated that findings which do not achieve formal statistical significance are less likely reported than statistically significant findings. Moreover, the patterns of bias can be complex and may also depend on the timing of the research results and their relationship with previously published work. In this paper, we present an approach that is specifically designed to analyze large-scale datasets on published results. Such datasets are currently emerging in diverse research fields, particularly in molecular medicine. We use our approach to investigate a dataset on Alzheimer's disease (AD) that covers 1167 results from case-control studies on 102 genetic markers. We observe that initial studies on a genetic marker tend to be substantially more biased than subsequent replications. The chances for initial, statistically non-significant results to be published are estimated to be about 44% (95% CI, 32% to 63%) relative to statistically significant results, while statistically non-significant replications have almost the same chance to be published as statistically significant replications (84%; 95% CI, 66% to 107%). Early replications tend to be biased against initial findings, an observation previously termed Proteus phenomenon: The chances for non-significant studies going in the same direction as the initial result are estimated to be lower than the chances for non-significant studies opposing the initial result (73%; 95% CI, 55% to 96%). Such dynamic patterns in bias are difficult to capture by conventional methods, where typically simple publication bias is assumed to operate. Our approach captures and corrects for complex dynamic patterns of bias, and thereby helps generating conclusions from published results that are more robust against the presence of different coexisting types of selective reporting.
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