Optimizing Enrollment of Patients into Nephrology Research Studies

Abstract

Advances in medical care and biomedical research depend on the participation of human subjects. Poor patient enrollment in research has limited past clinical and translational research endeavors in nephrology. Simultaneously, patients and their caregivers are seeking better diagnostic, monitoring, and therapeutic approaches to improve or restore kidney and overall health. This manuscript will discuss a framework and strategies to optimize patient enrollment within nephrology research and provide examples of success from existing nephrology research programs.

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

“…The most significant barriers to recruitment into the study included not having access to a mobile phone, having insufficient English to read and understand text messages, not being interested in participating in research. 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] .…”

“…After 36 months the data will be available in our Universities data warehouse but without investigator support other than deposited metadata. Data is presented as n(%) (95% confidence intervals) * p=0.6 for the comparison between the two arms, adjusting for geographical location of dialysis unit (stratification variable), using a logistic regression, ** p=0.1 for interaction of time and allocation, in the longitudinal analysis (secondary analysis), adjusting for local health district (stratification variable) Adaptive, cluster randomization by dialysis unit 22…”

“…• 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:…”

Informed consent within a learning health system: A scoping review

“…Alternate approaches to specific consent are often based on the use of technology, such as some forms of dynamic consent, in which consent choices can evolve over time . This makes particular sense in the context of a LHS .…”

Developing Treatments for Chronic Kidney Disease in the 21st Century

“…6,7 Slow patient enrollment (in part because of a lack of disease awareness), regulatory requirements for hard patient outcomes for drug registration, and lack of payer engagement are among the major obstacles impeding drug development for CKD. 6,8–10 Only consideration of the unmet medical need has continued to attract some pharmaceutical companies to the development of drugs for this indication.…”