Barriers and enablers to patient recruitment for randomised controlled trials on treatment of chronic wounds: A systematic review

Abstract

Randomised controlled trials represent the gold standard in intervention efficacy evaluation. However, suboptimal recruitment affects completion and the power of a therapeutic trial in detecting treatment differences. We conducted a systematic review to examine the barriers and enablers to patient recruitment for randomised controlled trials on chronic wound treatment. Review registration was under PROSPERO 2017:CRD42017062438. We conducted a systematic search of Ovid MEDLINE, EBSCOhost CINAHL, Ovid Cochrane Library, Ovid EMBASE, and Ovid PsycINFO databases in June 2017 for chronic wound treatment randomised controlled trials. Twenty-seven randomised controlled trials or qualitative studies met the inclusion criteria. Among the 24 randomised controlled trials, 21 were assessed as low quality in relation to recruitment, and 3 were assessed as high quality. All 27 studies reported barriers to recruitment in chronic wound randomised controlled trials. The reported barriers to recruitment were: study-related, patient-related, clinician-related, health system-related, and/or operational-related. No study reported recruitment enablers. To enhance randomised controlled trial recruitment, we propose the need for improved integration of research and clinical practice. To alleviate the problems arising from inadequate reporting of randomised controlled trials, the Consolidated Standards of Reporting Trials Statement could include an additional item on recruitment barriers. This approach will allow for increased awareness of the potential barriers to recruitment for Randomised controlled trials (RCTs) in both wound management and other health care research.

Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective

“…The barriers to participant recruitment in RCTs in various health fields reported to date are classified into 4 major groups; these are: participant‐related, health professional‐related, practice‐related, and study‐related . These groupings were confirmed by a recent systematic review of barriers and facilitators to RCTs in chronic wound management conducted by Bugeja and associates . The main facilitators to patient recruitment for RCTs in other health fields were reported as follows: support provided by the project researchers to health professionals and health professionals’ perceived benefits of the study results for their practice .…”

“…A qualitative approach has helped us identify various recruitment enablers and some relevant suggestions on how to improve recruitment rate of RCTs on wound management, although enablers are rarely reported, as the results of the recent systematic review has indicated. 15 However, these identified enablers and proposed suggestions should be considered with caution because some of them may not always work. For example, the availability of researchers on-site was discussed by many participants as the main enabler, although it helped to slightly increase the recruitment rate at 1 site.…”

“…6 These groupings were confirmed by a recent systematic review of barriers and facilitators to RCTs in chronic wound management conducted by Bugeja and associates. 15 The main facilitators to patient recruitment for RCTs in other health fields were reported as follows: support provided by the project researchers to health professionals and health professionals' perceived benefits of the study results for their practice. 6,16 Unfortunately, in the field of chronic wound management, study facilitators/enablers to participant recruitment in RCTs were not identified.…”

“…6,16 Unfortunately, in the field of chronic wound management, study facilitators/enablers to participant recruitment in RCTs were not identified. 15 Qualitative studies can provide a deeper insight on the barriers and facilitators of recruitment for RCTs and inform training initiatives. [17][18][19] French and Stavropoulou 16 developed a framework of factors influencing recruitment for RCTs based on data obtained from qualitative interviews with nurses on perceived factors that influenced recruitment.…”

Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

“…However, they said that refreshers during the course of recruitment could have been helpful. Clinicians' insufficient trial‐related skills were frequently reported as a barrier to recruitment . Clinicians' training, particularly related to recruitment and retention of participants, was reported as one of the potential strategies to improve the recruitment rate .…”