Incomplete reporting in clinical trials ‘holds back science’

Major deficiencies in health intervention research have been uncovered by a new study that found that nearly all recent trials involving schoolchildren were missing crucial information.

Analysis by University of Cambridge academics of 51 trials of physical activity interventions for children and adolescents conducted between 2015 and 2020 found “significant gaps” in how interventions were reported, meaning most of the studies were of “limited scientific use”.

Very basic information was often missing, with 62 per cent of studies failing to specify where the teachers had been trained, claims the study. The same proportion did not state whether the training had been adapted to meet teachers’ needs and skills, and 60 per cent did not mention whether teachers were trained in groups or individually.

When the 51 full trial reports and another 132 associated documents published across 33 academic journals were considered, only 2 per cent of published papers met the standard for including essential research information, as measured against a checklist, Template for Intervention Description and Replication, which was released in 2014.

The study, published in the journal Trials on 21 March, is likely to raise further questions about the issue of research replicability, which has been raised in many disciplines, as well as the issue of incomplete reporting.

“Inadequate intervention reporting is a widespread problem,” explained the study’s lead author, Mairead Ryan, a doctoral researcher at the Medical Research Council Epidemiology Unit at Cambridge. “If a trial is not described properly, scientists have no way of understanding the reasons behind its reported success or failure. This is preventing meaningful progress for researchers and practitioners,” she added.

When the research team assessed the submission guidelines of the academic journals that had published these reports, they found that just one encouraged the use of reporting checklists for all intervention components.

Members of the team then contacted each journal’s editor-in-chief (or equivalent) and asked them to update their guidelines. To date, 27 have responded. Seven have updated their guidelines; others are still in discussion with their editorial teams and publishers.

Encouraging the sector-wide use of journal guidelines can play a major role in changing the status quo, said Ms Ryan, noting that the 2013 Declaration of Helsinki on ethical principles for medical research involving human subjects identifies full reporting as an “ethical obligation” for researchers, authors, editors and publishers.

“We know that the quality of reporting is better in journals that endorse these checklists; researchers should be encouraged to use them when submitting their work,” she said.

jack.grove@timeshighereducation.com