Abstract
BackgroundRandomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias.MethodsNational and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias.ResultsSeventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported.ConclusionOur review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias. Current guidelines need to be updated and include the statement that all primary and secondary outcomes prespecified in the protocol should be fully reported and should not be selected for inclusion in the final report based on their results.
Highlights
Randomised controlled trials (RCTs) are planned experiments, involving the random assignment of patients to interventions, and are seen as the gold standard of methodological designs to evaluate the effectiveness of a treatment in medical research in humans [1].empirical research consistently suggests that published work is more likely to be statistically significant (P < 0.05) than unpublished research, and significant results have a higher probability of being published than non-significant outcomes [2]
There were 115 charities listed on the Association for Medical Research Charities (AMRC) website (108 originally listed charities including the 2 charities which were later removed from the website plus 7 newly added charities) of which 56 were eligible (Table 1)
By explicit reference it is meant that the charities/organisations guidelines referred to one of the guideline domains within their guidelines
Summary
Randomised controlled trials (RCTs) are planned experiments, involving the random assignment of patients to interventions, and are seen as the gold standard of methodological designs to evaluate the effectiveness of a treatment in medical research in humans [1].empirical research consistently suggests that published work is more likely to be statistically significant (P < 0.05) than unpublished research, and significant results have a higher probability of being published than non-significant outcomes [2]. Evidence suggests that published research without statistically significant results takes much longer to achieve publication than its statistically significant counterparts, further biasing evidence over time [3,4,5]. Such "study publication bias" is well recognised as a potential threat to the validity of any inference made as a result of a review of the literature [6]. Randomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias
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