Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report

Value in Health - Tập 10 Số 5 - Trang 326-335 - 2007
Louis P. Garrison1, Peter J. Neumann, Pennifer Erickson, Deborah A. Marshall, C. Daniel Mullins
1University of Washington, Seattle, WA 98195, USA. [email protected]

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Tài liệu tham khảo

Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. no. 108-173, 117 Stat 206 (2003).

Agency for Healthcare Research and Quality

Agency for Healthcare Research and Quality

Centers for Medicare and Medicaid Services

Neumann, 2004, Evidence-based and value-based formulary guidelines, Health Aff (Millwood), 23, 124, 10.1377/hlthaff.23.1.124

Academy of Managed Care Pharmacy

Oregon Health & Science University

National Institute for Health and Clinical Excellence

IQWIG

Sackett, 1996, Evidence based medicine: what it is and what it isn't, BMJ, 312, 71, 10.1136/bmj.312.7023.71

Woolf, 2000, Evidence-based medicine and practice guidelines: an overview, Cancer Control, 7, 362, 10.1177/107327480000700411

Wild, 2005, Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (pro) measures: report of the ISPOR task force for translation and cultural adaptation, Value Health, 8, 94, 10.1111/j.1524-4733.2005.04054.x

Acquadro, 2003, Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001, Value Health, 6, 522, 10.1046/j.1524-4733.2003.65309.x

US Department of Health and Human Services, Food and Drug Administration

Szende, 2005, Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003, Value Health, 8, 534, 10.1111/j.1524-4733.2005.00051.x

Guyatt, 1995, Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group, JAMA, 274, 1800, 10.1001/jama.1995.03530220066035

United States Department of Health and Human Services, Agency for Health Care Policy and Research, 1993

Harris, 2001, Current methods of the US Preventive Services Task Force: a review of the process, Am J Prev Med, 20, S21, 10.1016/S0749-3797(01)00261-6

Scottish Intercollegiate Guidelines Network

Harbour, 2001, A new system for grading recommendations in evidence based guidelines, BMJ, 323, 334, 10.1136/bmj.323.7308.334

American College of Cardiology Foundation

O'Sullivan, 2005, Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations?, Value Health, 8, 67, 10.1111/j.1524-4733.2005.03065.x

Tunis, 2003, Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy, JAMA, 290, 1624, 10.1001/jama.290.12.1624

Agency for Healthcare Research and Quality

Centers for Medicare and Medicaid Services

Glasgow, 2005, Practical clinical trials for translating research to practice: design and measurement recommendations, Med Care, 43, 551, 10.1097/01.mlr.0000163645.41407.09

D'Agostino, 1998, Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group, Stat Med, 17, 2265, 10.1002/(SICI)1097-0258(19981015)17:19<2265::AID-SIM918>3.0.CO;2-B

Crown, 1998, The application of sample selection models to outcomes research: the case of evaluating the effects of antidepressant therapy on resource utilization, Stat Med, 17, 1943, 10.1002/(SICI)1097-0258(19980915)17:17<1943::AID-SIM885>3.0.CO;2-0

Daniels, 2002

Claxton, 2005, When is evidence sufficient?, Health Aff (Millwood), 24, 93, 10.1377/hlthaff.24.1.93

Weinstein, 2003, Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—Modeling Studies, Value Health, 6, 9, 10.1046/j.1524-4733.2003.00234.x