Methodological Issues in Comparative Effectiveness Research: Clinical Trials

被引：9

作者：

Peduzzi, Peter ^{[1
,2
]}

Kyriakides, Tassos ^{[2
]}

O'Connor, Theresa Z. ^{[2
]}

Guarino, Peter ^{[2
]}

Warren, Stuart R. ^{[3
]}

Huang, Grant D. ^{[4
]}

机构：

[1] Yale Univ, Sch Publ Hlth, New Haven, CT 06519 USA

[2] US Dept Vet Affairs, VA Cooperat Studies Program, Coordinating Ctr, West Haven, CT USA

[3] US Dept Vet Affairs, VA Cooperat Studies Program, Clin Res Pharm Coordinating Ctr, Albuquerque, NM USA

[4] US Dept Vet Affairs, VA Cooperat Studies Program Cent Off, Washington, DC USA

来源：

AMERICAN JOURNAL OF MEDICINE | 2010年 / 123卷 / 12期

关键词：

Clinical trials; Comparative effectiveness research; Equipoise; RANDOMIZED-TRIAL; BYPASS-SURGERY; STABLE ANGINA; DESIGN; VETERANS; RATIONALE; THERAPY; DISEASE; COMPLICATIONS; EQUIPOISE;

D O I：

10.1016/j.amjmed.2010.10.003

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

The US Department of Veterans Affairs (VA) Cooperative Studies Program has been conducting comparative effectiveness clinical trials for nearly 4 decades in many disease areas, including cardiovascular disease/surgery, diabetes mellitus, mental health, neurologic disorders, cancer, infectious diseases, and rheumatoid arthritis. The features that have made this program advantageous for conducting comparative effectiveness clinical trials are described along with methodological considerations for future trials based on lessons learned from its experience conducting these types of studies. Some of the lessons learned involve managing risk factors, clinical equipoise, patient preferences, evolving technology, the use of usual care as a comparator and pharmaceutical issues related to study drug blinding. These issues are not unique to the VA but can play an important role in enabling valid comparisons between treatments that may have differences in delivery or mechanisms of action and could affect the execution and feasibility of conducting a clinical trial with a comparative effectiveness aim. We also outline some future directions for comparative effectiveness clinical trials. (C) 2010 Elsevier Inc. All rights reserved. The American Journal of Medicine (2010) 123, e8-e15

引用

页码：E8 / E15

页数：8

共 28 条

[1]

Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2 Veterans Affairs Diabetes Trial [J].

Abraira, C ;

Duckworth, W ;

McCarren, M ;

Emanuele, N ;

Arca, D ;

Reda, D ;

Henderson, W .

JOURNAL OF DIABETES AND ITS COMPLICATIONS, 2003, 17 (06) :314-322

[2]

Optimal medical therapy with or without PCI for stable coronary disease [J].

Boden, William E. ;

O'Rourke, Robert A. ;

Teo, Koon K. ;

Hartigan, Pamela M. ;

Maron, David J. ;

Kostuk, William J. ;

Knudtson, Merril ;

Dada, Marcin ;

Casperson, Paul ;

Harris, Crystal L. ;

Chaitman, Bernard R. ;

Shaw, Leslee ;

Gosselin, Gilbert ;

Nawaz, Shah ;

Title, Lawrence M. ;

Gau, Gerald ;

Blaustein, Alvin S. ;

Booth, David C. ;

Bates, Eric R. ;

Spertus, John A. ;

Berman, Daniel S. ;

Mancini, G. B. John ;

Weintraub, William S. ;

Boden, W. ;

O'Rourke, R. ;

Teo, K. ;

Hartigan, P. ;

Weintraub, W. ;

Maron, D. ;

Mancini, J. ;

Weintraub, W. ;

Boden, W. ;

O'Rourke, R. ;

Teo, K. ;

Hartigan, P. ;

Knudtson, M. ;

Maron, D. ;

Bates, E. ;

Blaustein, A. ;

Booth, D. ;

Carere, R. ;

Ellis, S. ;

Gosselin, G. ;

Gau, G. ;

Jacobs, A. ;

King, S., III ;

Kostuk, W. ;

Harris, C. ;

Spertus, J. ;

Peduzzi, P. .

NEW ENGLAND JOURNAL OF MEDICINE, 2007, 356 (15) :1503-1516

[3]

Design and rationale of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial:: Veterans Affairs Cooperative Studies Program no. 424 [J].

Boden, William E. ;

O'Rourke, Robert A. ;

Teo, Koon K. ;

Hartigan, Pamela M. ;

Maron, David J. ;

Kostuk, William ;

Knudtson, Merril ;

Dada, Marcin ;

Casperson, Paul ;

Harris, Crystal L. ;

Spertus, John A. ;

Shaw, Leslee ;

Chaitman, Bernard R. ;

Mancini, John ;

Berman, Daniel S. ;

Weintraub, William S. .

AMERICAN HEART JOURNAL, 2006, 151 (06) :1173-1179

[4]

CASS PRINC IN, 1983, CIRCULATION, V68, P939

[5]

CHALMERS TC, 1978, CLIN RES, V26, P230

[6]

CHALMERS TC, 1975, MED CLIN N AM, V59, P1045

[7]

*CLINICALTRIALS GO, RHEUM ARTHR COMP ACT

[8]

Considering Usual Medical Care in Clinical Trial Design [J].

Dawson, Liza ;

Zarin, Deborah A. ;

Emanuel, Ezekiel J. ;

Friedman, Lawrence M. ;

Chaudhari, Bimal ;

Goodman, Steven N. .

PLOS MEDICINE, 2009, 6 (09)

[9]

DETRE KM, 1984, NEW ENGL J MED, V311, P1333

[10]

Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes [J].

Duckworth, William ;

Abraira, Carlos ;

Moritz, Thomas ;

Reda, Domenic ;

Emanuele, Nicholas ;

Reaven, Peter D. ;

Zieve, Franklin J. ;

Marks, Jennifer ;

Davis, Stephen N. ;

Hayward, Rodney ;

Warren, Stuart R. ;

Goldman, Steven ;

McCarren, Madeline ;

Vitek, Mary Ellen ;

Henderson, William G. ;

Huang, Grant D. .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (02) :129-U62

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