Using real-world data for coverage and payment decisions: The ISPOR real-world data Task Force report

Value in Health

Volumn 10, Issue 5, 2007, Pages 326-335

  Garrison Jr , Louis P ^a   Neumann, Peter J ^b   Erickson, Pennifer ^c   Marshall, Deborah ^d   Mullins, C Daniel ^e  

^a UNIVERSITY OF WASHINGTON   (United States)

^b TUFTS MEDICAL CENTER   (United States)

^c OLGA   (United States)

^d i3 Global   (Canada)

^e UNIVERSITY OF MARYLAND   (United States)

Author keywords

Methodology; Outcomes research; Real world data; Research design

Indexed keywords

ARTICLE; BILLING AND CLAIMS; CONCEPTUAL FRAMEWORK; COST BENEFIT ANALYSIS; DISEASE REGISTRY; DRUG INDUSTRY; EVIDENCE BASED MEDICINE; HEALTH CARE COST; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HEALTH INSURANCE; HEALTH SURVEY; HUMAN; INFORMATION PROCESSING; MEDICAL DECISION MAKING; MEDICAL PRACTICE; MEDICAL RECORD REVIEW; MEDICAL SCHOOL; OUTCOME ASSESSMENT; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE PAYMENT; QUALITY OF LIFE; REIMBURSEMENT; RISK BENEFIT ANALYSIS;

EID: 34748856744     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2007.00186.x     Document Type: Article

References (31)

1. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. no. 108-173, 117 Stat 206 (2003).
2. Agency for Healthcare Research and Quality. Effective Heath Care Program. 2006. Available from: http://effectivehealthcare.ahrq.gov/aboutUS/index.cfm [Accessed July 13, 2006].
3. Agency for Healthcare Research and Quality. AHRQ Launches Project to Develop Guide for Patient Registries. Press release, December 7, 2005. Available from: http://www.ahrq.gov/news/press/pr2005/ptregpr.htm [Accessed December 21, 2006].
4. Centers for Medicare and Medicaid Services. National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. 2006. Available from: http://www.cms.hhs.gov/mcd/ ncpc_view_document.asp?id=8 [Accessed December 21, 2006].
5. Neumann PJ. Evidence-based and value-based formulary guidelines. Health Aff (Millwood) 2004 23 : 124 34.
6. Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions, Version 2.1. 2005. Available from: http://www.amcp.org/amcp.ark?c=pr&sc=link [Accessed July 13, 2006].
7. Oregon Health & Science University. Drug Effectiveness Review Project, 2006. Available from: http://www.ohsu.edu/drugeffectiveness/reports/ final.cfm [Accessed July 13, 2006].
8. National Institute for Health and Clinical Excellence. 2006. Available from: http://www.nice.org.uk/ [Accessed July 13, 2006].
9. IQWIG. German Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. 2006. Available from: http://www.iqwig.de/ [Accessed July 13, 2006].
10. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. BMJ 1996 312 : 71 2.
11. Woolf SH. Evidence-based medicine and practice guidelines: an overview. Cancer Control 2000 7 : 362 7.
12. Wild D, Grove A, Martin M, et al. 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 2005 8 : 94 104.
13. Acquadro C, Berzon R, Dubois D, et al. 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 2003 6 : 522 31.
14. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2006. Available from: http://www.fda.gov/cber/gdlns/prolbl.pdf [Accessed July 13, 2006].
15. Szende A, Leidy NK, Revicki D. 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 2005 8 : 534 48.
16. Guyatt GH, Sackett DL, Sinclair JC, et al. Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA 1995 274 : 1800 4.
17. United States Department of Health and Human Services, Agency for Health Care Policy and Research. Acute Pain Management: Operative or Medical Procedures and Trauma. 92-0023, 107. Rockville, MD : AHCPR, 1993. Clinical Practical Guideline No. 1.
18. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001 20 (3 Suppl. S21 35.
19. Scottish Intercollegiate Guidelines Network. 2006. Available from: http://www.sign.ac.uk/ [Accessed July 17, 2006].
20. Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ 2001 323 : 334 6.
21. American College of Cardiology Foundation. Clinical Statements and Guidelines. 2006. Available from: http://www.acc.org/qualityandscience/clinical/ statements.htm [Accessed April 15, 2007].
22. O'Sullivan AK, Thompson D, Drummond MF. Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations? Value Health 2005 8 : 67 79.
23. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003 290 : 1624 32.
24. Agency for Healthcare Research and Quality. Effective HealthCare, DEcIDE: Registries for Evaluating Patient Outcomes. 2006. Available from: http://effectivehealthcare.ahrq.gov/decide/registryOutline.cfm [Accessed July 18, 2006].
25. Centers for Medicare and Medicaid Services. Guidance for the Public, Industry, and CMS Staff: National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. 2005. Available from: http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8 [Accessed July 23, 2006].
26. Glasgow RE, Magid DJ, Beck A, et al. Practical clinical trials for translating research to practice: design and measurement recommendations. Med Care 2005 43 : 551 7.
27. D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998 17 : 2265 81.
28. Crown WH, Obenchain RL, Englehart L, et al. The application of sample selection models to outcomes research: the case of evaluating the effects of antidepressant therapy on resource utilization. Stat Med 1998 17 : 1943 58.
29. Daniels N, Sabin J. Setting Limits Fairly: Can We Learn to Share Medical Resources? New York : Oxford University Press, 2002.
30. Claxton K, Cohen JT, Neumann PJ. When is evidence sufficient? Health Aff (Millwood) 2005 24 : 93 101.
31. Weinstein MC, O'Brien B, Hornberger J, et al. 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 2003 6 : 9 17.