Ciaran S Phibbs1,2,3, Sean R Love4,5, Alan K Jacobson6,7, Robert Edson8, Pon Su9, Lauren Uyeda8, David B Matchar4,10,11. 1. Health Economics Resource Center, VA Palo Alto Health Care System, Palo Alto, CA, USA. CiaranPhibbs@va.gov. 2. Department of Pediatrics and Center for Primary Care and Outcomes Research, Stanford University School of Medicine, Stanford, CA, USA. CiaranPhibbs@va.gov. 3. Health Economist, VA Health Economics Resource Center, 795 Willow Road (152MPD), Menlo Park, CA, 94025, USA. CiaranPhibbs@va.gov. 4. Health Services and Systems Research Program, Duke-National University of Singapore Graduate Medical School, Singapore, Singapore. 5. Warren Alpert Medical School of Brown University, Providence, RI, USA. 6. Jerry L. Pettis VA Medical Center, Research and Development Service (151), Loma Linda, CA, USA. 7. Department of Internal Medicine, Loma Linda University, Loma Linda, CA, USA. 8. VA Palo Alto Health Care System, Cooperative Studies Program Coordinating Center (151 K), Palo Alto, CA, USA. 9. Health Economics Resource Center, VA Palo Alto Health Care System, Palo Alto, CA, USA. 10. Durham VA Medical Center, Durham, NC, USA. 11. Division of General Medicine, Department of Medicine, and Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC, USA.
Abstract
BACKGROUND: Effective management of patients usingwarfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/ INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS:PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.
RCT Entities:
BACKGROUND: Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/ INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS: PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.
Authors: Rowena J Dolor; R Lynne Ruybalid; Lauren Uyeda; Robert G Edson; Ciaran Phibbs; Julia E Vertrees; Mei-Chiung Shih; Alan K Jacobson; David B Matchar Journal: J Thromb Thrombolysis Date: 2010-10 Impact factor: 2.300
Authors: Josep M Garcia-Alamino; Alison M Ward; Pablo Alonso-Coello; Rafael Perera; Clare Bankhead; David Fitzmaurice; Carl J Heneghan Journal: Cochrane Database Syst Rev Date: 2010-04-14
Authors: David B Matchar; Alan Jacobson; Rowena Dolor; Robert Edson; Lauren Uyeda; Ciaran S Phibbs; Julia E Vertrees; Mei-Chiung Shih; Mark Holodniy; Philip Lavori Journal: N Engl J Med Date: 2010-10-21 Impact factor: 91.245
Authors: David B Matchar; Sean R Love; Alan K Jacobson; Robert Edson; Lauren Uyeda; Ciaran S Phibbs; Rowena J Dolor Journal: J Thromb Thrombolysis Date: 2015-07 Impact factor: 2.300
Authors: Greg Samsa; David B Matchar; Rowena J Dolor; Ingela Wiklund; Ewa Hedner; Gail Wygant; Ole Hauch; Cheryl Beadle Marple; Roger Edwards Journal: Health Qual Life Outcomes Date: 2004-05-06 Impact factor: 3.186
Authors: Martin van Zyl; Waldemar E Wysokinski; Thomas M Jaeger; Ana I Casanegra; Bernard J Gersh; Robert D McBane Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2020-08-15
Authors: Daniel M Witt; Robby Nieuwlaat; Nathan P Clark; Jack Ansell; Anne Holbrook; Jane Skov; Nadine Shehab; Juliet Mock; Tarra Myers; Francesco Dentali; Mark A Crowther; Arnav Agarwal; Meha Bhatt; Rasha Khatib; John J Riva; Yuan Zhang; Gordon Guyatt Journal: Blood Adv Date: 2018-11-27