Patients’ desire to learn, help others with ESKD outweighs payment in study enrollment
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Key takeaways:
- Most participants enrolled in kidney studies rated overall satisfaction as high.
- Primary motivators to enroll were altruism, knowledge gain and access to new treatments.
Patients’ desire to help others and learn more about their kidney disease rated higher than financial incentives when it came to study enrollment, recently published data show.
Researchers led by Sneha Amin, MB, BS, of Michael Stern Laboratory for Polycystic Kidney Disease at The University of Sydney, investigated factors affecting recruitment and retention in a long-term clinical trial for autosomal dominant polycystic kidney disease (ADPKD).
Recruitment
“The timely recruitment of participants and maintaining their retention are one of the main key performance indicators that define the efficient conduct of a clinical trial,” Amin and colleagues wrote. The study aimed to “determine the experiences of participants in a long-term trial; identify factors influencing reasons to enroll, remain and adhere to trial procedures; and develop preliminary recommendations for improving future clinical trials,” they wrote in the paper, which was published in Kidney Medicine.
The randomized controlled trial included 187 participants who were invited to complete a 16-item questionnaire at the final study visit. Additionally, 31 participants were selected for semi-structured interviews based on age, gender and randomization group.
Results showed that 79% of participants completed the post-trial questionnaire, while 21% finished the interview. Most (94%) rated their overall satisfaction with the trial as high. Primary motivators to enroll were altruism, or helping others; gaining more knowledge about their disease; and access to new treatments.
Conversely, participants rated financial incentives and encouragement from caregivers as “not being important,” the study found.
Study burden
Participants reported the main study burden was time away from work and lost wages. They also said the burden of taking MRI scans and 24-hour urine collections were obstacles.
As it pertains to retention, researchers found this was mainly determined by patient perception of potential adverse effects of the intervention, nature of the study procedures and time required. Concerns about risks and family or work issues were the main reasons for patients who considered leaving the study.
Flexibility in attending different sites, schedule flexibility, staff interactions and practical support may improve retention.
While the study was restricted to participants in a single non-drug clinical trial and results could be influenced by selection or social desirability bias, the findings can have implications for improving the study design of recruitment and recruitment of ADPKD, the authors wrote.
“Current treatments for autosomal dominant polycystic kidney disease are only partially effective,” they wrote, “and thus randomized controlled trials are vital for developing new therapeutic advances.”
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