Participant Perceptions in a Long-term Clinical Trial of Autosomal Dominant Polycystic Kidney Disease.

Autor:	Amin S; Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia., Sangadi I; Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia.; Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia., Allman-Farinelli M; School of Nursing, The University of Sydney, Sydney, Australia., Badve SV; St George Hospital, Sydney, Australia.; The George Institute for Global Health, University of New South Wales, Sydney, Australia., Boudville N; Sir Charles Gairdner Hospital, Perth, Australia.; Medical School, University of Western Australia, Perth, Australia., Coolican H; Polycystic Kidney Disease Australia, Roseville, Australia., Coulshed S; North Shore Nephrology, Sydney, Australia., Foster S; Department of Radiology, Westmead Hospital, Western Sydney Local Health District, Sydney, New South Wales.; Discipline of Medical Imaging Science, Sydney School of Health Sciences, The University of Sydney, Sydney, Australia., Fernando M; Department of Renal Medicine, Prince of Wales Hospital, Sydney, Australia., Haloob I; Department of Renal Medicine, Bathurst Hospital, Bathurst, Australia., Harris DCH; Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia.; Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia., Hawley CM; Australasian Kidney Trials Network, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia.; Translational Research Institute, Brisbane, Australia.; Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia., Holt J; Department of Renal Medicine, Wollongong Hospital, Wollongong, Australia., Howell M; School of Public Health, The University of Sydney, Sydney, NSW, Australia., Kumar K; Gosford Nephrology, Gosford, Australia., Johnson DW; Australasian Kidney Trials Network, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia.; Translational Research Institute, Brisbane, Australia.; Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia., Lee VW; Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia.; Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia., Mai J; Department of Renal Medicine, Liverpool Hospital, Southwestern Sydney Local Health District, Sydney, Australia., Rangan A; School of Nursing, The University of Sydney, Sydney, Australia., Roger SD; Renal Research, Gosford, Australia., Sud K; Department of Renal Medicine, Nepean Kidney Research Centre, Nepean Hospital and Nepean Clinical School, The University of Sydney, Sydney, Australia., Torres V; Translational Polycystic Kidney Disease Center, Mayo Clinic, Rochester, MN., Vilayur E; Department of Nephrology, John Hunter Hospital, Newcastle, Australia., Rangan GK; Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia.; Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.
Jazyk:	angličtina
Zdroj:	Kidney medicine [Kidney Med] 2023 Jun 29; Vol. 5 (9), pp. 100691. Date of Electronic Publication: 2023 Jun 29 (Print Publication: 2023).
DOI:	10.1016/j.xkme.2023.100691
Abstrakt:	Rationale & Objective: The development of new therapies for autosomal dominant polycystic kidney disease requires clinical trials to be conducted efficiently. In this study, the factors affecting the recruitment and retention of participants enrolled in a 3-year randomized controlled trial in autosomal dominant polycystic kidney disease were investigated. Study Design: Qualitative study. Setting & Participants: All participants (N=187) were invited to complete a 16-item questionnaire at the final study visit of the primary trial. Participants were recruited to complete a semistructured interview using purposeful sampling according to age, self-reported gender, and randomization group. Analytical Approach: Descriptive statistics were used for demographic data and questionnaires. The interview transcripts underwent inductive thematic coding. Results: One hundred and forty-six of the 187 randomized participants (79%) completed the post-trial questionnaire, and 31 of the 187 participants (21%) completed the interview. Most participants (94%) rated their global satisfaction with the trial as high (a score of 8 or more out of 10). Altruism, knowledge gain, and access to new treatments were the main motivators for recruitment. The main reasons for considering leaving the study were concerns about the risk of intervention and family or work issues. Strategies that favored retention included flexibility in attending different study sites, schedule flexibility, staff interactions, and practical support with parking and reminders. The main burden was time away from work with lost wages, and burden associated with magnetic resonance imaging scans and 24-hour urine output collections. Limitations: The study population was restricted to participants in a single nondrug clinical trial, and the results could be influenced by selection and possible social desirability bias. Conclusions: Participants reported high levels of satisfaction that occurred as a function of the trial meeting participants' expectations. Furthermore, retention was a balance between the perceived benefits and burden of participation. Consideration of these perspectives in the design of future clinical trials will improve their efficiency and conduct. Plain-Language Summary: Advances in the clinical practice of autosomal dominant polycystic kidney disease (ADPKD) require affected individuals to voluntarily participate in long-term multicenter randomized controlled trials (RCTs). In this qualitative post hoc study of a 3-year RCT of increased water intake in ADPKD, altruism, knowledge gain, and access to a nondrug treatment positively influenced the decision to volunteer. Ongoing participation was enabled by building flexibility into the study protocol and staff prioritizing a participant's needs during study visits. Although participants completed the required tests, most were considered burdensome. This study highlights the importance of incorporating protocol flexibility into trial design; the preference for interventions with a low risk of adverse effects; and the urgent requirement for robust surrogate noninvasive biomarkers to enable shorter RCTs in ADPKD. (© 2023 The Authors.)
Databáze:	MEDLINE
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