Table 2.

Barriers to dialysis research implementation and identified solutions by research phasea

Design phase
 1. Lack of early involvement of dialysis organizations, clinics, and patients in protocol development• Plan ahead so there is time to consider stakeholder perspectives
 2. Lack of guidance on how to incorporate local stakeholders into research development• Develop formal processes for researchers to obtain early (i.e., before funding and IRB approval) input from stakeholders
 3. Disconnect among researchers, dialysis organizations, clinics, and patients• Develop a crossdialysis organization research consortium to facilitate better understanding between dialysis providers and researchers
 4. Lack of researcher (especially industry-based researcher) access to medical providers• Develop best practices for research design in the dialysis setting with input from all stakeholders
 5. Lack of transparency about dialysis organization and clinic research policies• Develop organization-specific, on-line repositories for research policies that are accessible to clinic personnel and researchers
 6. Variation in research policies within and across dialysis organizations• Reduce redundancy in approval processes
 7. Burdensome, multistep approval processes
Conduct phase
 1. Complex, burdensome protocols that are unaligned with the practicalities of dialysis clinical care and regulations• Emphasize engagement of all stakeholders in design phase with ongoing engagement through conduct phase
 2. Competing demands for clinic personnel time, including regulatory requirements for care delivery• Engage in forward-thinking discussions with CMS, NIH, and ASN about the practical costs and potential savings from stakeholder-informed research
 3. Protocols that do not account for patient routines, physical limitations (e.g., vision, dexterity), privacy, transportation, or cultural and/or linguistic barriers• Develop a “day-in-the-life of a dialysis clinic” video for researchers new to the dialysis environment
 4. Hidden protocol costs including personnel burden, transportation, physical space, and clinic supplies• When feasible, perform environmental assessments to understand clinic-specific workflows and cultures
 5. High personnel turn-over resulting in need for retraining that is not accounted for in timelines or budgets• When feasible, conduct pilot studies to inform design of larger studies
 6. Clinic personnel uncertainty about who to contact with protocol questions• Use the governing body as a key informant/partner
 7. Overly complicated study explanations for clinic personnel and patients• Utilize clinic personnel, medical provider, and patient “champions”
 8. Insufficient communication during study conduct• Allot professional time for clinic personnel engagement and identify meaningful incentives for personnel and medical providers
 9. Lack of standardized data collection and informed consent forms and complicated patient and clinic personnel-facing study materials• Maintain privacy (e.g., portable cubicles, tablet with earphones; separate area) for patients participating in research
 10. Researcher difficulty in accessing dialysis IT infrastructure, leading to duplicative data collection• When feasible and appropriate, use “warm hand-offs” between clinic personnel and research teams where trusted individuals introduce research team members to potential study participants
• Include budget in funding applications to account for stakeholder engagement and sufficient personnel training and retraining
• Empower clinic personnel to ask questions by making research team contact information prominent
• Provide prespecified, regular study updates and use plain language communications delivered in multiple formats
• Utilize videos to convey information
• Set expectations about communication plans
• Develop standardized data collection and informed consent forms that can be tailored to individual studies
• Develop clear policies for how researchers can access research participant medical information
Dissemination phase
 1. Lack of transparency about dialysis organizations’ rules and regulations related to dissemination• Develop organization-approved templates for research updates
 2. Lack of channels for dissemination; researchers with limited access to contact information and information often out-of-date• Develop relatable messaging for study updates and results
 3. Study results that are inaccessible to diverse stakeholders (e.g., provided as scientific communications only)• Distribute a research newsletter; use “lobby days”; give thank you notes with study results; provide updates at governance meetings
• Utilize patient organizations to disseminate results (e.g., monthly patient newsletters, social media accounts)
• Require communication and dissemination plans in funding applications
• Evaluate the effectiveness of research dissemination efforts
  • IRB, institutional review board; CMS, Centers for Medicare and Medicaid Services; NIH, National Institutes of Health; ASN, American Society of Nephrology; IT, information technology.

  • a As collaboratively identified by workshop attendees.