Lessons Learned in Participant Recruitment and Retention: The EXCITE Trial

Abstract

Participant recruitment is considered the most difficult aspect of the research process. Despite the integral role of recruitment in randomized clinical trials, publication of data defining the recruitment effort is not routine in rehabilitation initiatives. The recruitment process for the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial illustrates obstacles to and strategies for participant accrual and retention that are inherent in rehabilitation clinical trials. The purpose of this article is to increase awareness of the multiple facets of recruitment necessary for successful clinical trials, thus supporting the continued development of evidence-based practice in physical therapy. The Recruitment Index is presented as a variable to measure recruitment efficacy. In addition, ethical aspects of recruitment are explored, including informed consent and the concept of therapeutic misconception.

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

“…The difficulty with the paternalistic approach is that the roles of healthcare provider and clinical investigator may carry different and competing obligations [18,28,29]. Subjects manifest a therapeutic misconception when they fail to realize that by participating in clinical trials they sacrifice some degree of personal care, which is the primary allegiance that healthcare workers have towards them [30].…”

Recruitment rate and retention of stroke subjects in cross-sectional studies

“…Importantly, at the first contact, all potential participants received information regarding the purpose of the assessments. Although, in the present study, the subjects did not get any financial compensation to get involved, it is important to note that in a previous study which provided reimbursement for transportation, parking, and food (cost ranged from US$ 20.00 to US$ 50.00 per session), low retention was also observed 11 .…”

“…invalid or inconclusive results and increase the length and costs of the study 7 . Thus, better understanding regarding recruitment and having a solid strategy, while doing so, is of major importance for rehabilitation scientists, since high recruitment rates are crucial to research and evidence-based practice 11 . For example, even though the researchers from the present study had a long list of contacts (654 subjects), only 25% (165 subjects) of them actually participated, demonstrating the difficulty in carrying-out the recruitment process.…”

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

“…Unfortunately, the authors did not report the time taken to recruit participants as well as the strategies implemented for this task. Blanton et al 19 evaluated the aspects of recruitment and retention of participants during a clinical trial investigating the efficacy of constraint-induced therapy in hemiplegic patients after stroke. They screened 3,626 patients in six different cities in the United States of America during a period of two years.…”