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Chest. 2012 Feb;141(2 Suppl):e185S-e194S. doi: 10.1378/chest.11-2289.

Approach to outcome measurement in the prevention of thrombosis in surgical and medical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

Author information

1
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: guyatt@mcmaster.ca.
2
Department of Medicine, McMaster University, Hamilton, ON, Canada.
3
Keck School of Medicine, University of Southern California, Los Angeles, CA.
4
University of New Mexico, Albuquerque, NM.
5
St. Joseph's Hospital, Hamilton, ON, Canada.
6
Mayo Clinic, Rochester, MN.
7
Centre for Clinical Epidemiology and Community Studies, Jewish General Hospital, Montreal, QC, Canada.
8
Case and VA Medical Center, Case Western Reserve University, Cleveland, OH.
9
University of Rochester, Rochester, NY.
10
Stanford Stroke Center, Palo Alto, CA.
11
State University of New York at Buffalo, Buffalo, NY.
12
David Braley Cardiac, Vascular, and Stroke Research Institute, Hamilton, ON, Canada.

Abstract

This article provides the rationale for the approach to making recommendations primarily used in four articles of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines: orthopedic surgery, nonorthopedic surgery, nonsurgical patients, and stroke. Some of the early clinical trials of antithrombotic prophylaxis with a placebo or no treatment group used symptomatic VTE and fatal PE to measure efficacy of the treatment. These trials suggest a benefit of thromboprophylaxis in reducing fatal PE. In contrast, most of the recent clinical trials comparing the efficacy of alternative anticoagulants used a surrogate outcome, asymptomatic DVT detected at mandatory venography. This outcome is fundamentally unsatisfactory because it does not allow a trade-off with serious bleeding; that trade-off requires knowledge of the number of symptomatic events that thromboprophylaxis prevents. In this article, we review the merits and limitations of four approaches to estimating reduction in symptomatic thrombosis: (1) direct measurement of symptomatic thrombosis, (2) use of asymptomatic events for relative risks and symptomatic events from randomized controlled trials for baseline risk, (3) use of baseline risk estimates from studies that did not perform surveillance and relative effect from asymptomatic events in randomized controlled trials, and (4) use of available data to estimate the proportion of asymptomatic events that will become symptomatic. All approaches have their limitations. The optimal choice of approach depends on the nature of the evidence available.

PMID:
22315260
PMCID:
PMC3278047
DOI:
10.1378/chest.11-2289
[Indexed for MEDLINE]
Free PMC Article

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