Leveraging observational registries to inform comparative effectiveness research

American Heart Journal

Volumn 160, Issue 1, 2010, Pages 8-15

  Shah, Bimal R ^a,b   Drozda, Joseph ^c   Peterson, Eric D ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^c Sisters of Mercy Health System   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; FUNDING; HEALTH CARE COST; HEALTH CARE QUALITY; HUMAN; INVESTMENT; MEDICAL INFORMATION; METHODOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REGISTER; REVIEW; TECHNOLOGY;

BIOMEDICAL RESEARCH; COMPARATIVE EFFECTIVENESS RESEARCH; HEALTH CARE COSTS; HUMANS; QUALITY OF HEALTH CARE; UNITED STATES;

EID: 77955683121     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2010.04.012     Document Type: Review

References (44)

1. Gibbons R.J., Gardner T.J., and Anderson J.L. The American Heart Association's principles for comparative effectiveness research. a policy statement from the American Heart Association Circulation 119 2009 2955 2962
2. American College of Physicians. Improved availability of comparative effectiveness information: an essential feature for a high-quality and efficient United States health care system. Philadelphia: American College of Physicians; 2008: position paper. (Available from American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.)
3. Institute of Medicine, Roundtable on Evidence-based Mediciner. July 27, 2006. Available at: http://www.iom.edu/?id=28186&redirect=0. Last accessed March 12, 2010.
4. Drozda J.P., Bufalino V.J., and Fasules J.W. ACC 2009 advocacy position statement: principles for comparative effectiveness research J Am Coll Cardiol 54 2009 1744 1746
5. Creating a center for evidence-based medicine Available at: http://www.medpac.gov/documents/Feb08-Center-EvidenceBased-CONTRACTOR-NR.pdf Last accessed March 12, 2010
6. Clancy C.M. AHRQ's research efforts in comparative effectiveness: statement before the U.S. House of Representatives Committee on Ways and Means SoHJ Available at: http://www.ahrq.gov/news/sp061207.htm 2007
7. Government-funded comparative effectiveness research Available at: http://www.advamed.org/NR/rdonlyres/66E43D28-1F5F-4028-99CC-256A7BE25D53/0/ AdvaMedCEPrinciples22102407.pdf Last accessed March 12, 2010
8. Principles for government-supported health outcomes research on medical technologies and services Available at: http://www.phrma.org/health-outcomes- research Last accessed March 12, 2010
9. Tunis S.R. A clinical research strategy to support shared decision making Health Aff 24 2005 180 184
10. Federal Coordinating Coucil Report to the President and the Congress on comparative effectiveness research Available at: http://www.hhs.gov/recovery/ programs/cer/execsummary.html Last accessed March 12, 2010
11. Califf R.M., and Mark D.B. Percutaneous intervention, surgery, and medical therapy: a perspective from the Duke Databank for Cardiovascular Diseases Semin Thorac Cardiovasc Surg 6 1994 120 128
12. Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data Circulation 68 1983 939 950
13. The American Recovery and Reinvestment Act of 2009. H.R.1. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111-cong- bills&docid=f:h1enr.pdf Last accessed May 6, 2010
14. Tricoci P., Allen J.M., and Kramer J.M. Scientific evidence underlying the ACC/AHA clinical practice guidelines JAMA 301 2009 831 841
15. Lee P.Y., and Alexander K.P. Representation of elderly persons and women in published randomized trials of acute coronary syndromes JAMA 286 2001 708 713
16. DiMasi J.A., Hansen R.W., and Grabowski H.G. The price of innovation: new estimates of drug development costs J Health Econ 22 2003 151 185
17. Nallamothu B.K., Hayward R.A., and Bates E.R. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies Circulation 118 2008 1294 1303
18. Concato J., Shah N., and Horwitz R.I. Randomized, controlled trials, observational studies, and the hierarchy of research designs N Engl J Med 342 2000 1887 1892
19. Benson K., and Hartz A.J.A. Comparison of observational studies and randomized, controlled trials N Engl J Med 342 2000 1878 1886
20. Jollis J.G., Ancukiewicz M., and DeLong E.R. Discordance of databases designed for claims payment versus clinical information systems. Implications for outcomes research Ann Intern Med 119 1993 844 850
21. McNamara R.L., Brass L.M., and Drozda J.P. Jr ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Commitee to Develop Data Standards on Atrial Fibrillation) J Am Coll Cardiol 44 2004 475 495
22. Radford M.J., Arnold J.M., and Bennett S.J. ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Failure Society of America Circulation 112 2005 1888 1916
23. Cannon C.P., Battler A., and Brindis R.G. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes: a report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American College of Emergency Physicians, American Heart Association, Cardiac Society of Australia and New Zealand, National Heart Foundation of Australia, Society for Cardiac Angiography and Interventions, and the Taiwan Society of Cardiology J Am Coll Cardiol 38 2001 2114 2130
24. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules Available at: http://www.cms.hhs.gov/HIPAAGenInfo Last accessed March 12, 2010
25. Peterson E.D., Shah B.R., and Parsons L. Trends in quality of care for patients with acute myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006 Am Heart J 156 2008 1045 1055
26. Lin G.A., Dudley R.A., and Lucas F.L. Frequency of stress testing to document ischemia prior to elective percutaneous coronary intervention JAMA 300 2008 1765 1773
27. O'Connor G.T., Quinton H.B., and Traven N.D. Geographic variation in the treatment of acute myocardial infarction: the Cooperative Cardiovascular Project JAMA 281 1999 627 633
28. Alexander K.P., Chen A.Y., and Roe M.T. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes JAMA 294 2005 3108 3116
29. Normand S.L.T. Some old and some new statistical tools for outcomes research Circulation 118 2008 872 884
30. Krumholz H.M. Outcomes research: generating evidence for best practice and policies Circulation 118 2008 309 318
31. Honig P.K., Wortham D.C., and Zamani K. Terfenadine-ketoconazole interaction. Pharmacokinetic and electrocardiographic consequences JAMA 269 1993 1513 1518
32. Kearney P.M., Baigent C., and Godwin J. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials BMJ 332 2006 1302 1308
33. Mukherjee D., Nissen S.E., and Topol E.J. Risk of cardiovascular events associated with selective COX-2 inhibitors JAMA 286 2001 954 959
34. Food and Drug Administration The Sentinel initiative: a national strategy for monitoring medical product safety Available at: http://www.fda.gov/Safety/ FDAsSentinelInitiative/ucm089474.htm Last accessed March 12, 2010
35. LaPointe N.M.A., Chen A.Y., and Alexander K.P. Enoxaparin dosing and associated risk of in-hospital bleeding and death in patients with non-ST-segment elevation acute coronary syndromes Arch Intern Med 167 2007 1539 1544
36. Peterson E.D., Kaul P., and Kaczmarek R.G. From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes J Am Coll Cardiol 42 2003 1611 1616
37. Sunil V.R., Richard E.S., and Ralph G.B. On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]) Am J Cardiol 97 2006 1478 1481
38. Food and Drug Administration Guidance for industry and FDA staff procedures for handling post-approval studies imposed by PMA order Available at: http://www.fda.gov/cdrh/osb/guidance/1561.html Last accessed March 12, 2010
39. Agency for Healthcare Research and Quality. Methods reference guide for effectiveness and comparative effectiveness reviews. Draft. Rockville (MD). Available at: http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype= nr&DocID=12&ProcessID=21. Last accessed March 12, 2010.
40. Stukel T.A., Fisher E.S., and Wennberg D.E. Analysis of observational studies in the presence of treatment selection bias: effects of invasive cardiac management on AMI survival using propensity score and instrumental variable methods JAMA 297 2007 278 285
41. Kurth T., Walker A.M., and Glynn R.J. Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of nonuniform effect Am J Epidemiol 163 2006 262 270
42. Ho P.M., Peterson P.N., and Masoudi F.A. Evaluating the evidence: is there a rigid hierarchy? Circulation 118 2008 1675 1684
43. Califf R.M., Peterson E.D., and Gibbons R.J. Integrating quality into the cycle of therapeutic development J Am Coll Cardiol 40 2002 1895 1901
44. Federal Coordinating Council for Comparative Effectiveness Research Report to the President and Congress. Washington DDoHaHS Available at: http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf 2009 Last accessed November 3, 2009