Improving Recruitment Into Research Studies via Electronically Collected Patient-Entered Data: Mixed Methods Study.

Area of Science:

• Clinical research methodology
• Precision medicine initiatives
• Patient engagement in healthcare

Background:

• Patient recruitment is a major hurdle in clinical research.
• Current recruitment methods can increase patient burden and compromise autonomy.
• Identifying patient attributes predictive of research participation is crucial for efficient outreach.

Purpose of the Study:

• To develop patient-reported questions assessing perceptions of research participation.
• To determine if these patient responses predict interest in a precision medicine registry.

Main Methods:

• A mixed-methods, sequential exploratory design was used.
• Phase 1: Cognitive interviews with 32 patients to develop "research perception" questions.
• Phase 2: A cross-sectional study of 1077 primary care patients using electronic questionnaires.

Main Results:

• Patients expressed strong support for research; 97% agreed it should be an institutional mission.
• 25.8% of patients expressed interest in the precision medicine registry.
• Positive responses to "research perception" questions significantly predicted interest (aORs 6.36-17.6), with high sensitivity but limited specificity.

Conclusions:

• Patient-reported questions effectively identify individuals likely to enroll in clinical studies.
• This approach enhances recruitment prioritization, respects patient autonomy, and reduces burden.
• High sensitivity makes questions valuable for screening; limited specificity necessitates use for prioritization, not exclusion.