Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis

Abstract

Background There is a need to improve participatory approaches in health care research in order to ensure that the most important questions of patients and the public are answered. The International Network for Knowledge on Well-being (ThinkWell) research programme aims to use online technologies to promote user-led research in health care. However, it is unclear how many clinical trials have been conducted using internet-based technologies, and how these map against coverage of health care conditions and interventions, or share learning and expertise in methods. Objectives This research project was designed to create a database of randomised trials in health care conducted using internet technologies. The database has provided a source of data for ThinkWell researchers, including help in determining how many randomized trials have used internet-based technologies as part of their trial processes, what stages of the trial process use these technologies, and how use has developed over time. In addition a range of trial characteristics have been mapped including the range of conditions and topics, types of interventions, trial participants and use of participatory methods. Methods A comprehensive literature search was undertaken in order to retrieve a set of relevant research reports, from a wide range of sources. Results were imported into a bibliographic software package and screened against inclusion and exclusion criteria. Included studies were then mapped against a number of key dimensions, with the key themes developed iteratively throughout the process. The final set of studies has been exported into a database, browsable by the key identified facets, and also searchable by text word. The database has been made available to the ThinkWell research team for further analysis and use. Results The initial database searches were conducted between January 2011 and September 2012 and retrieved 16,824 results. Following screening a final database of 1513 studies was created. In addition to core bibliographical details, studies were coded for topic or condition; country; intervention; trial stage and participatory methods. There is a predominance of activity in interventions related to core public health issues such as obesity, smoking, alcohol misuse, and physical activity, and in mental health issues such as depression and anxiety. The other main theme covers conditions where self-management or monitoring is a major feature of care. Conclusions The results from the database creation exercise demonstrate the increase in the use of internet technologies within internet-based clinical trials. A number of key themes have emerged from the analysis including location of expertise, and the predominance of trials covering specific conditions and interventions. A number of other challenges emerged from the research including issues relating to the reporting of internet-based trials, and retrieval issues resulting from a lack of consistent taxonomies and indexing. Further research will be undertaken in order to investigate how well participant experiences in internet-based clinical trials has been understood, and how the data can be used to improve trial design and recruitment, and to support the public-led research agenda. []