Abstract
BackgroundRandomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues is rare. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention.MethodsAll registered UK clinical trials unit directors were sent a short questionnaire and invited to interview. Representatives of funding bodies and other stakeholders were also approached. Interviews were recorded and the content analysed.ResultsData were grouped into four themes: acceptance of the need for methodological research; trial funding and development; trial processes; and organisational factors. The need to improve the evidence base for trials methodology is well established, but numerous barriers to implementation were perceived.ConclusionsThe knowledge and expertise required to routinely implement methodology research exists within the current research structures, and there are clear opportunities to develop the evidence base. However, for this to be achieved there is also a need for clear strategic coordination within the sector and promotion of the necessary resources.
Highlights
Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention
Data collection We report the qualitative research in line with the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidance [8]
Our preliminary work suggested that implementation of Study within a trial (SWAT) amongst trialists would be affected by the operation of two key organisations: funding bodies and Clinical trials unit (CTU)
Summary
Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention. Randomised controlled trials are fundamental to evidence-based practice. Increasing numbers of studies are being conducted worldwide, but recruitment and retention remain significant challenges. This highlights the importance of methodological work to improve trial delivery and quality. The aspects of trial design and delivery tested in SWATs vary, ranging from modest, no-cost or low-cost comparisons, such as modifying patient information sheets [3], to more substantial endeavours Methods used in SWATs can include simple before-and-after studies and non-randomised comparisons, but our particular interest is in the subset of SWATs which themselves use a randomised design
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
