Abstract
In the course of producing the 2009 NHS Evidence - skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of trial reporting were identified. Several trials concluded no effect of a treatment yet they were insufficiently powered to exclude potentially useful benefits. There were examples of duplicate publication and "salami publication", as well as two trials being combined and reported as one. In some cases, an incorrect "within-groups" statistical comparison was made and one trial report omitted original efficacy data and included only P values. Both of the non-inferiority studies examined failed to pre-specify a non-inferiority margin. Trials reported as "double-blind" compared treatments that were dissimilar in appearance or had differing adverse effect profiles. In one case an intention-to-treat analysis was not performed and there was a failure to account for all of the randomized participants. Trial results were made to sound more impressive by selective outcome reporting, emphasizing the statistical significance of treatment effects that were clinically insignificant, and by the use of larger-sounding odds ratios rather than rate ratios for common events. Most of the reporting problems could have been avoided by use of the CONSORT guidelines and prospective trial registration on a public clinical trials database.
Highlights
Each year, NHS Evidence - skin disorders publishes an Annual Evidence Update on Acne Vulgaris, which is a search for new evidence published or indexed in the last year [1]
An equivalence margin was not determined in advance and the equivalence claim was made on the basis of non-significant tests for superiority, a problem frequently encountered in clinical trial reporting [6]
Many of the problems outlined in this article could have been avoided by adherence to the CONSORT guidelines [31] and prospective trial registration
Summary
NHS Evidence - skin disorders (a national specialist library funded by NICE, available at http://www. library.nhs.uk/skin) publishes an Annual Evidence Update on Acne Vulgaris, which is a search for new evidence published or indexed in the last year [1]. In the course of putting together the Annual Evidence Update [1,3] the authors were struck by a high frequency of problems in the reporting and interpretation of these acne RCTs, which are highlighted in this article. Our perspective in this commentary is not to condemn well-intentioned authors but to highlight common problems that may not be immediately obvious to a wider readership in the hope of reducing bias, improving patient welfare and influencing the future conduct and reporting of clinical trials on acne. Given will help to provide further evidence for the need to improve standards in the reporting of all clinical trials
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