SMOOTH: Self-Management Open Online Trials in Health An Analysis of Existing Online Trials

BACKGROUND: The use of online clinical trials is growing, but there remains little practical guidance on their conduct and it is sometimes challenging for researchers to adapt the conventions used in face-to-face trials and maintain the validity of the work. Online trials of self-management may indicate how an intervention will be used in daily practice as the online environment can mirror the self-management of care increasingly expected. The Online Randomized Controlled Trials of Health Information Database (ORCHID) contains health trials undertaken using the internet which were systematically sought and cataloged. This ORCHID analysis provides insight into the current state of online clinical trials. \ud \ud AIM: To systematically explore existing self-recruited online randomized trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of reporting and the involvement of participants in the research process.\ud \ud METHODS: ORCHID was used as a sampling frame to identify a subset of self-recruited looking at self-management interventions. These were appraised to explore the qualities of self-recruited online randomized trials and to evaluate the usefulness of online trials for obtaining trustworthy answers to questions about health self-management and citizen research involvement.\ud \ud RESULTS: The sample included (n=41) online trials published from 2002-2015. Trial quality was critically appraised as High (n=9), Medium-high (n=15), Medium (n=17), and low as (n=1). Descriptive settings in (N=23/41) trials provided insufficient information to be replicable and did not report piloting or testing platforms before the trial launch. Reporting of patient and public involvement was more common than in face-to-face trials, however reporting, replicability, and methods used in online randomized trials of self-recruited self-management interventions were sub-optimal and dissemination strategies were sparse and reported in only (n=1) trial. \ud \ud CONCLUSIONS: The information gained in this study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage.