Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Abstract

Background: Inadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving.

Methods: We aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting, provider, recipient, comparator, intervention intensity, how it was conducted, existence of a manual or protocol, and detail of whether there was an assessment of fidelity). Score per item was '1' if reported adequately and '0' if not.

Results: Of the eligible trials, 42 were published in Time-1 and 134 published in Time-2. The trials included were published in 112 peer-reviewed journals, 52 of these journals currently require authors to follow the CONSORT Statements, while only one recommended adherence to the TIDieR. Most items of CONSORT and TIDieR were reported by more than half of the trials at both time points. Few trials reported fidelity. A large proportion of the trials did not report the existence of a manual or protocol, or what the comparator group received. We found no statistically significant improvement in the eight-item quality score (Time-1: mean 5.71 (standard deviation (SD) 1.09), Time-2: 5.87 (SD 1.28), p = 0.49).

Conclusions: We found no overall evidence that reporting the specifics of multicomponent, non-pharmacological interventions is improving. Details to replicate interventions remain lacking, impairing best implementation or meaningful further research. Editorial endorsement of reporting checklists needs to be more extensive.

Keywords: CONSORT; Complex intervention content; Reporting standards; TIDieR; Trials.

Fig. 1

Review flow chart