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More guidance needed to check outcome reporting bias, says report -

Open access publisher BioMed Central, UK, has announced that its journal Trials has published a review of reporting guidelines for randomised controlled trials (RCTs), conducted by Dwan et al. The report, Reporting of clinical trials: a review of research funders' guidelines, highlights the need for more detailed guidance from RCT funders to prevent outcome reporting bias (ORB).

As part of the Outcome Reporting Bias in Trials (ORBIT) project, set up to investigate the prevalence of ORB and its impact on the outcome of systematic reviews, this study assessed reporting guidelines from national and international organisations, as well as UK based charities, which fund RCTs. Assessment was carried out with regard to trial registration, protocol adherence, trial publication and monitoring.

Publication bias, where statistically significant results are more likely to be published than those that are statistically insignificant, is a well-recognised problem. However, ORB, where publications report only a subset of the original variables according to the nature of the results, is an equally important but less well-documented issue. It was found that although trial registration, protocol adherence, trial publication and monitoring were frequently discussed, only 11 of the 73 organisations and charities contacted mentioned the publication of both negative and positive outcomes.

The authors conclude that the majority of funders are yet to incorporate ORB into their recommendations. They further state that more detailed guidance, stating the importance of reporting all primary and secondary outcomes specified in the protocol, regardless of the nature of results, is required to prevent the selective reporting of outcomes.

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