Recruitment and retention in clinical trials in chronic kidney disease: report from national workshops with patients, caregivers and health professionals

Abstract

Background Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational. Methods We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease. Results We identified four themes. ‘Navigating the unknown’—patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. ‘Wary of added burden’—patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. ‘Disillusioned and disconnected’—some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed ‘Building motivation and interest’. Conclusions Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament.

A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis

“…The lack of randomised controlled trials (RCTs) of complex arts-based interventions for people with chronic illnesses is an established issue [9], compounded further by the challenges of conducting RCTs in nephrology. Trials in nephrology, the most under-researched field of internal medicine, are marked by problems with the retention of participants [10], partially because of the substantial treatment burden patients already experience and uncertainty around research processes [11]. Other issues that impact trials in nephrology include aspects of trial design, such as appropriate selection of outcome measures or practical aspects of trial conduct [12].…”

A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis

“…Trials in nephrology, the most under-researched eld of internal medicine, are marked by problems with the retention of participants [10], partially because of the substantial treatment burden patients already experience and uncertainty around research processes. [11] Other issues that impact trials in nephrology include aspects of trial design, such as appropriate selection of outcome measures or practical aspects of trial conduct. [12] In order to address the issues that have historically impacted trials in nephrology, such as recruitment, attrition, randomisation and appropriate selection of outcome measures, it is important to conduct a feasibility study to identify issues that may impact a de nitive trial, without jeopardising evaluations of e cacy.…”

A Text Messaging Intervention for Dietary Behaviors for People Receiving Maintenance Hemodialysis: A Feasibility Study of KIDNEYTEXT

“…These barriers are generally consistent with the literature regarding challenges of recruitment into nephrology studies 22 . Potential methods in which to improve recruitment in a future trial could be to design an adaptive, cluster (by dialysis unit) randomized study with the intervention embedded into current renal nutrition services to promote buy-in from clinicians and enrolling patients through trusted clinicians and enhancing the participation of dialysis staff in the development and implementation of the intervention [22][23][24] .…”

“…• Pragmatic study design that is embedded within current renal nutritional care 22,23 • Consent process facilitated through renal clinicians (i.e. dietitians, nurses, nephrologists), rather than specific research staff 22,24 • Additional online portal patients can opt into without clinicians 22 • Use of a care givers' mobile phone if necessary or preferred by the patient Follow-up 6 month intervention with 3 month of follow-up Blinding Outcome assessors to be blinded Interventions Three mobile phone text messages per week for 6 months. Enhancement of personalisation of text messages by:…”