Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting?An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial RegistrationPLoS | ONEby Amelia Scott, Julia J. Rucklidge, and Roger T. MulderAugust 19, 2015
Objective: To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors [ICMJE] introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrollment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Materials and Methods: Any clinical trial [as defined by ICMJE] published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines [The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry] and conducted after July 2005 [or 2007 for two journals] was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Results: Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 [11.6%] were deemed unregistered, 61 [33.7%] were retrospectively registered, 37 [20.4%] had unclear POMs either in the article or the registry and 2 [1.1%] were registered in an inaccessible trial registry. Only 60 [33.1%] studies were prospectively registered with clearly defined POMs; 17 of these 60 [28.3%] showed evidence of selective outcome reporting and 16 [26.7%] demonstrated a change in participant numbers of 20% or more; only 26 [14.4%] of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.Discussion: Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.
[see also Is Mandatory Trial Registration Decontaminating the Psychiatric Literature? by Julia Rucklidge, Ph.D. on Mad in America].
So to my post-it notes. They add one other vital thing, the a priori study protocol [I’m 100% serious about the vital part]. Among many other things, it lays out what variables will be assessed and exactly how they will be analyzed. Most, if not all, RCT distortion involves not following the a priori study protocol [or having a biased protocol from the start]…
[truncated and rearranged to fit]
And of the 60 that were preregistered and carried into the publication, only 26 POMs were used without some evidence of jury-rigging [14.1 %]! Pitiful!
And ~half of those retrospectively registered trials were registered over a year after the study began. Also pitiful!
Twenty-one [11.6%] of the 181 studies were deemed unregistered, 61 [33.7%] were retrospectively registered, 37 [20.4%] had unclear POMs either in the article or the registry and 2 [1.1%] were registered in an inaccessible trial registry. Only 60 [33.1%] studies were prospectively registered with clearly defined POMs.
But seventeen of these 60 [28.3%] properly registered trials showed evidence of selective outcome reporting – this means that there had been changes to POMs based on a comparison of the trial registry and the publication. In total, only 26 [14.4%] of the 181 trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.