Table 1 Challenges and suggestions to enhance recruitment of patients with SCI into a research study in a rehabilitation hospital.
Challenges | Suggestions | |
---|---|---|
Enrollment | • Demographic and injury-specific shifts a. Increasing age b. Increased incomplete tetraplegia and decreased complete injuries • Placement • Bombardment and competition • Volume of patients • Time frame to make decision for enrollment • Informed consent | • Implement stratified randomization methods to accommodate varying injury severities and maximize enrollment • Consider collaboration with non-traditional centers, such as LTACH and SCI rehabilitation centers without existing research infrastructure • Educate patients and families on the benefits of research participation to enhance motivation • Foster communication and collaboration among staff to avoid competition for patient enrollment • Disclose all potential studies to patients, prioritizing their rights to be informed • Develop a clear process for approaching patients and families about studies • Simplify informed consent processes with clear, concise information and additional support for decision-making • Collaborate with IRBs and ethics committees to continuously assess the risk-benefit ratio of studies |
Logistical challenges | • Time for intervention • Resource availability | • Form integrated teams of researchers, clinicians, rehabilitation personnel, with input from persons with lived experience, to coordinate care and research effectively • Employ adaptive scheduling to integrate research activities without disrupting essential services • Utilize shared resources to ensure lab and personnel availability • Design shorter intervention trials |
Health status | • Medical factors that may interfere with study • Adjustment issues | • Conduct thorough medical screenings and stabilize patients before enrollment and during the study period • Design study protocols flexible enough to accommodate medical complications • All team members should monitor for adjustment issues • Ensure close collaboration and communication between research personnel and clinical teams with consistent hand-offs |
Outcome Measures | • Many are not clinically used, adding study burden • Shortened LOS may influence change in some measures at discharge • Functional capabilities at rehabilitation discharge may not reflect the reality at home | • Focus on clinically relevant outcome measures • Use validated outcome measurement tools appropriate for SCI research that align with patient real life activities • Minimize secondary outcome measures to diminish burden |
Retention and Follow-up | • Lost to follow up • Transportation and scheduling conflicts • Burden of research • Psychological factors • Lack of perceived benefit • Discharge settings not conducive for follow up | • Implement a tracking system and follow-up plan including virtual visits • Provide incentives to facilitate ongoing participation in follow-up assessments including compensation and transportation from home or local facilities • Create a welcoming follow-up atmosphere and address medical, social, and psychological issues during visits to increase perceived value and appreciation of participation |