Reporting of interventions: a comparative case study before and after the publication of the extended CONSORT guidelines for reporting non-pharmacological trials

Article type
Authors
Candy B1, Vickerstaff V1, Jones L1, King M1
1University College London (UCL), United Kingdom
Abstract
Background: Limited description of interventions in trial publications wastes resources and potentially harms patients. Interventions cannot be replicated or assessed for generalizability if they are poorly described. Even if found to be ineffective, complete description of an intervention is needed to reduce resource waste and inform approaches. Recognition of the need to improve reporting is not new. Both the 2008 extension to CONSORT statements for non-pharmacological interventions, and the 2010 revised CONSORT statement emphasized the importance of full reporting of the details of an intervention.
Objectives: We explore whether intervention reporting is improving. We compare descriptions of similar non-pharmacological interventions in trials undertaken before and after 2008.
Methods: We reviewed 182 trials included in a Cochrane Review on interventions for enhancing therapy adherence (Nieuwlaat 2014). We included for increased similarity only psychotherapeutic and educational multi-component interventions. We split the trials into two groups: 1) those published before 2008; and 2) those published after 2008. Two authors independently assessed intervention description. We compared description according to:
- number of words and sentences;
- reporting of setting, recipient, provider, procedure, materials and intensity;
- use of descriptive aids such as tables and access to supplementary documents.
We compared the trials' description of their intervention between the groups according to whether the intervention was found to be effective, and whether it was published in a leading general medical journal.
Results: We have extracted intervention content of the trials. Overall reporting of the content was variable. Early results suggest that trials published after 2008 generally provide longer descriptions of the intervention of interest than those published before 2008 (median word length pre 2008 was 236, post 2008 it was 296).
Conclusions: To our knowledge, this is the first comparative study of standards of historical and current intervention reporting. Our results will identify areas for improvement. The result may inform future guidelines.