Quantification of the External Validity of Randomized Controlled Trials Supporting Clinical Care Guidelines: The Case of Thromboprophylaxis

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• 作者：Sami Morin-Ben Abdallah ; MD ; Aurore Dutilleul ; MD ; Valé ; rie Nadon ; MD ; Ji Wei Yang ; MD ; Xavier Marchand-Sé ; né ; cal ; MD ; Paul Van Nguyen ; MD ; Maxime Lamarre-Cliche ; MD ; MSc ; Robert Wistaff ; MD ; Christophe Kolan ; MD ; Mikhael Laskine ; MD ; MSc ; ^{mikhael.laskine.chum@ssss.gouv.qc.ca" class="auth_mail" title="E-mail the corresponding author} ; Madeleine Durand ; MD ; MSc
• 关键词：American College of Chest Physicians guidelines ; Exclusion criteria ; External validity ; Medical hospitalized patients ; Padua score ; Pharmacological thromboprophylaxis ; Risk scores
• 刊名：The American Journal of Medicine
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：129
• 期：7
• 页码：740-745
• 全文大小：181 K

文摘

Clinical guidelines are based on the results of several randomized controlled trials. However, due to the stringent exclusion criteria of these trials, their external validity may be low. We aimed to evaluate the external validity of the randomized controlled trials cited in the American College of Chest Physicians guidelines for the use of pharmacological thromboprophylaxis in hospitalized medical patients.

Methods

We conducted a cross-sectional, chart-review study of a random sample of patients admitted between July 1, 2013 and June 30, 2014 to the Internal Medicine ward of a large Canadian teaching university hospital. We identified the proportion of our population presenting exclusion criteria used in the randomized controlled trials cited in support of clinical care guidelines on thromboprophylaxis in the medical setting.

Results

Nine trials were identified for a total of 28,793 included patients following 23 distinct exclusion criteria. We included 429 patients. Median age was 65 years (interquartile ratio 51-77 years), and 236 (55%) were males. Of those not already anticoagulated at admission (n = 351), between 26% and 67% (weighted average, 51%) of our population presented at least one exclusion criterion, making them ineligible to be enrolled in randomized controlled trials. When restricting our population to patients with an indication for thromboprophylaxis based on a Padua risk score at admission ≥4, 21% to 76% (weighted average 55%) were ineligible to be enrolled in individual trials.

Conclusions

Our cross-sectional study illustrates that the external validity of randomized controlled trials cited in the guidelines was low in our population, and lower when applying the risk-stratification tool recommended by guidelines. This can bias the clinicians toward treating patients that were not represented in the supporting evidence.