AFFIRM, atrial fibrillation, clinical trial, patient satisfaction, survey



  1. Kellen, Joyce C. MSc, BN
  2. Schron, Eleanor B. MS, RN, FAAN, FAHA
  3. Milne, Jill PhD, MN
  4. Chandler, Mary L. MD, MS
  5. Berg, Claire M. MS, RN
  6. Ritchie, Deborah A. MN, BScN
  7. Paterson, Diana BScN, BA
  8. Sweeney, Patricia A. BScN, RN
  9. Nelson, Joy D. BA, RN
  10. Mickel, Mary MS
  11. AFFIRM Investigators and Coordinators


Background: Patients' views about participation in clinical trials have been explored using end-of-study questionnaires for various disease entities. However, little is known about why individuals with atrial fibrillation (AF) choose to participate in clinical trials or how they view their research experience. Understanding these perceptions should provide valuable information for future studies in developing methods to enhance enrollment, optimize adherence to therapies, and maximize patient retention.


Methods: The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study was a randomized trial of rate-control versus rhythm-control for the management of AF. This descriptive ancillary study used a 7-item questionnaire comprising closed and open-ended items that explored: (1) perceptions of benefits from participation, (2) motivation for enrolling, and (3) satisfaction with research staff and operations.


Results: A total of 741/1,032 participants (72%) at 34 of 213 participating AFFIRM sites responded, representing 18% of the 4,060 patients enrolled. The mean follow-up of these respondents was 3.8 +/- 1.1 years. Most respondents (91%) felt that they received enough information about AFFIRM before enrolling and that the results would benefit themselves (88%) and others (91%). Most respondents felt study participation improved awareness about AF (90%) and facilitated coordination of their healthcare (89%). Virtually all were satisfied with information received from AFFIRM personnel (96%), and most (98%) reported that they had received "good care." Responses were similar between randomization groups (rate-control or rhythm-control) and between those younger than 65 years and those 65 years or older. Participants in sinus rhythm at last follow-up were more likely to believe that their medical care in AFFIRM was better than what they would otherwise have received, and were more likely to perceive their treatment course as entailing fewer emergency room visits, hospitalizations, and doctor visits. Regularly scheduled appointments and ongoing availability of staff to answer questions appeared to increase participants' confidence and reduce anxiety.


Conclusions: Patients enrolled in a long-term clinical trial for management of AF were overwhelmingly satisfied with participation.