15 highly questionable practices in clinical trial publications
The editor of three nursing journals has just published a list of shenanigans and "quite blatant inaccuracies" detected during her team's screening of clinical trials reports.
Here is the full list:
Trials not being registered on authorized trials registries when are they were eligible. [Note: This is actually a clear ethics violation as per Declaration of Helsinki ]
Authors claiming that their trials were prospectively registered before the first participant was recruited, but the dates in the trial registration entry indicate otherwise.
Authors reporting the registration number of a totally different trial to that reported in their submission.
The trial described in the trial report differing (sometimes substantially) from the trial registry entry and/or the protocol with no explanation provided.
The sample size calculation not undertaken for the primary outcome
Selective reporting of outcomes
Not reporting all outcomes in a single trial report
Manipulation of primary and secondary outcomes to favour outcomes with the biggest effect
Inappropriate or poorly conducted analyses
The reported trial being under powered and the results, conclusions and recommendations for practice not supported by the evidence
Submitting manuscripts as quantitative or mixed-methods studies and avoiding mention that the study design was actually a trial, presumably to avoid the requirements of registration.
Resubmitting trial reports that have previously been rejected by the journal even though the identified issues were not resolvable (such a retrospective registration) – presumably in the hope that the same issues would not be picked up second time round.
Various concerns about ethics approvals, including whether the trial had been approved by an ethics committee. In at least one case, investigations revealed that the trial was not approved by an ethics committee.
Trials that significantly favoured the intervention, and no conflict of interest was stated when the trial was funded by the manufacturer of the intervention.
Concerns about lack of research governance within the institutions from which the trial reports were submitted.
The list was compiled by Jane Noyes, editor of the journals Advanced Nursing, Clinical Nursing and Nursing Open.
The list was published as part of an open access editorial that explains how these journals detect and react to these practices.
Note: See here for another excellent discussion of quality and accuracy problems in clinical trial publications.
Publication of outcomes on trial registries avoids many - but not all - of the problems listed above.
Registry reporting is recommended by the WHO for all trials, and is already legally required for some trials under U.S. and European Union laws to prevent such Questionable Research Practices (QRPs) from distorting the medical evidence base.