Roadmap Part 2 — Future Directions for PFIC CER
Strategies to Reduce the Burden of Study Participation
IMPACT participants also brainstormed a list of ways to design a patient-centered CER study that would motivate and reduce the burden for PFIC patients and families to participate.
For practical tools to support PFIC CER study planning – including a worksheet on reducing participant burden – download the Researcher Companion (see p.20).
List of Strategies
Create a trusted and welcoming environment
- A strong recommendation from a trusted physician
- Mental health/psychological support if needed
- A dedicated case manager/care coordinator
- A communication specialist trained to answer questions for the trial
- Warm, welcoming, and patient research staff
- Personalized reminders
- Toys or presents for child participants
Time and compensation
- Limited time required away from family
- Services offered at home or through local clinics if possible
- Minimal number of hospital visits required
- Financial compensation
- Flexible timing of visits
- Scheduling visits during breaks from school to minimize disruption
- Shorter visits
Medical considerations
- Minimal medical trauma anticipated
- Avoiding invasive procedures (e.g. by using surveys)
- No blood samples in addition to routine draws
Other considerations
- Frequent updates on study progress, changes, and results
- A transparent plan for dissemination of study results
- Setting clear expectations
- Support for smaller centers to enroll study participants
