Conference: 2012 International PHA Conference and Scientific Sessions
Release Date: 06.22.2012
Presentation Type: Abstracts
Antonia Heininger;1 Dave Haney, RRT;2 Susan Oxborough, RN, CVN;3 Page Scovel, RN, BSN;4 Abby M. Poms, BS, RRT;5 Louise Durst, RN;6 Barbara Smithson, RN, BSN;7 Ann Bogran, RN, BSN;8 Loubov Mintas, BA;9 Karen Visnaw, RN;10 Dave P. Miller, MS;11 Prieya Wason, CCRP;12 Kathleen Feldkircher, PhD;12 Harrison W. Farber, MD13
1. University of Rochester Medical Center, Rochester, NY
2. University Hospital of Cleveland, Cleveland, OH
3. Aurora St. Luke’s Medical Center, Milwaukee, WI
4. University of Iowa Hospital and Clinics, Iowa City, IA
5. Duke University School of Medicine, Durham, NC
6. Mayo Clinic College of Medicine, Rochester, MN
7. Rhode Island Hospital, Providence, RI
8. Texas Children’s Hospital, Houston, TX
9. University of Pittsburgh UPMC Heart and Vascular Institute, Pittsburgh, PA
10. Tufts Medical Center, Boston, MA
11. ICON Late Phase & Outcomes Research, San Francisco, CA
12. Actelion Pharmaceuticals US, Inc., South San Francisco, CA
13. Boston University School of Medicine, Boston, MA
BACKGROUND: The Registry to EValuate EArly and Long-term pulmonary arterial hypertension (PAH) Disease Management (REVEAL) was created in 2005 to provide clinical information, including ongoing clinical management practices and population changes, on the largest cohort of patients with Group 1 PAH ever collected. Here, the structure of REVEAL was examined to identify components that contribute to the framework of a successful registry.
METHODS: REVEAL is a 55-center, observational, US-based registry designed to collect demographic, clinical, and disease management data on ~3500 patients with PAH. In addition to close communication and site management, 20% of sites are chosen each year for monitoring. Percent completion and accuracy of the abstracted data are critical study metrics reported at annual and semi-annual meetings.
RESULTS: A multi-disciplinary partnership, inclusive of all stakeholders, enables all participants to possess ownership of study outputs. Patient characteristics and outcomes are reviewed with both investigators and study coordinators annually with audience participation. Individual scientific inquiries based on core study objectives are led by the steering committee or by investigators and study coordinators who submit proposals. To date, there were >75 presentations at scientific congresses and 15 peer-reviewed manuscripts accepted for publication. Data completion and query resolution goals with high-quality results were consistently achieved by sites, with >95% case report form completion annually over the prior 5 years. A mix of automated and manual queries allowed focused effort on data fields related to new scientific questions. A critical contributor to the success of REVEAL is annual dissemination of new data via study personnel meetings and teleconferences, promoting a high level of scientific discussion, attention to data quality, and robust results.
CONCLUSIONS: REVEAL provides a large, centralized data source for patients with PAH. A collective approach among all team members is essential for accurate, long-term data collection. This innovative model is an excellent example of a successful registry as measured by the quantity and quality of scientific output.