Patient Perceptions of the Challenges to Recruitment Into a Renal Rct Registry : A Pilot Questionnaire Based Study

Abstract

Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. Despite this, nephrology trials, especially of patients with end-stage renal disease (ESRD) are much fewer in number than other medical subspecialties. Recruitment difficulties are cited as a particular challenge. Using registries to conduct RCTs is a reasonably new practice but is appealing as it combines the benefits of both observational studies and clinical trials. There is limited literature on patient motivators, barriers, and consent to these registries. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for randomised controlled trial, and to determine what information matters to patients when making an enrolment decision to participate in such a registry. MethodsWe conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results 87 patients completed the questionnaire. Reasons for participation in the registry included personal and altruistic benefits. Barriers were time and travel requirements associated with registry participation, data safety concerns, risks, and side effects, along with concerns that registry participation would impact their current treatment. Although 29.8% of patients expressed, that they would have concerns regarding their data being stored in a registry, 79.3% of patients were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. ConclusionChallenges to recruitment to registries for RCTs exist but addressing the identified concerns of potential participants may improve recruitment to registries, and by extension, to RCTs conducted using the registry.