Hugh Calkins1, Richard E Gliklich2, Michelle B Leavy3, Jonathan P Piccini4, Jonathan C Hsu5, Sanghamitra Mohanty6, William Lewis7, Saman Nazarian8, Mintu P Turakhia9. 1. Cardiology Division, Johns Hopkins University, Baltimore, Maryland. 2. OM1, Inc., Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. Electronic address: rgliklich@om1.com. 3. OM1, Inc., Boston, Massachusetts. 4. Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina. 5. Sulpizio Cardiovascular Center, University of California San Diego, La Jolla, California. 6. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas. 7. MetroHealth System, Case Western Reserve University, Cleveland, Ohio. 8. The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 9. VA Palo Alto Health Care System and Stanford University, Stanford, California.
Abstract
BACKGROUND: Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization. OBJECTIVES: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice. METHODS: AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.
BACKGROUND:Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AFpatient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization. OBJECTIVES: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AFpatient registries and clinical practice. METHODS:AFpatient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.
Authors: Sana M Al-Khatib; Emelia J Benjamin; Alfred E Buxton; Hugh Calkins; Mina K Chung; Anne B Curtis; Patrice Desvigne-Nickens; Pierre Jais; Douglas L Packer; Jonathan P Piccini; Yves Rosenberg; Andrea M Russo; Paul J Wang; Lawton S Cooper; Alan S Go Journal: Circulation Date: 2019-11-20 Impact factor: 29.690
Authors: Martin J Edelman; Daniel P Raymond; Dwight H Owen; Michelle B Leavy; Kari Chansky; Sriram Yennu; Felix G Fernandez; Carolyn J Presley; Tithi Biswas; Gwendolyn P Quinn; Matthew B Schabath; Seth Sheffler-Collins; Laura Chu; Richard E Gliklich Journal: J Natl Compr Canc Netw Date: 2021-08-13 Impact factor: 12.693
Authors: William H Seligman; Zofia Das-Gupta; Adedayo O Jobi-Odeneye; Elena Arbelo; Amitava Banerjee; Andreas Bollmann; Bridget Caffrey-Armstrong; Daniel A Cehic; Ramon Corbalan; Michael Collins; Gopi Dandamudi; Prabhakaran Dorairaj; Matthew Fay; Isabelle C Van Gelder; Shinya Goto; Christopher B Granger; Bathory Gyorgy; Jeff S Healey; Jeroen M Hendriks; Mellanie True Hills; F D Richard Hobbs; Menno V Huisman; Kate E Koplan; Deirdre A Lane; William R Lewis; Trudie Lobban; Benjamin A Steinberg; Christopher J McLeod; Spencer Moseley; Adam Timmis; Guo Yutao; A John Camm Journal: Eur Heart J Date: 2020-03-07 Impact factor: 29.983
Authors: Chayakrit Krittanawong; Albert J Rogers; Kipp W Johnson; Zhen Wang; Mintu P Turakhia; Jonathan L Halperin; Sanjiv M Narayan Journal: Nat Rev Cardiol Date: 2020-10-09 Impact factor: 32.419
Authors: Allyson L Varley; Omar Kreidieh; Brigham E Godfrey; Carolyn Whitmire; Susan Thorington; Benjamin D'Souza; Steven Kang; Shrinivas Hebsur; Bipin K Ravindran; Edwin Zishiri; Brett Gidney; Matthew B Sellers; David Singh; Tariq Salam; Mark Metzl; Alex Ro; Jose Nazari; Westby G Fisher; Alexandru Costea; Anthony Magnano; Saumil Oza; Gustavo Morales; Anil Rajendra; Joshua Silverstein; Paul C Zei; Jose Osorio Journal: J Interv Card Electrophysiol Date: 2021-07-02 Impact factor: 1.900