OBJECTIVE: To determine the percentage of individuals that would be excluded from wound care randomized controlled trials (RCTs) as a surrogate for applicability to general populations.
DESIGN: A representative sample of wound-care RCTs was selected from the literature in the past 10 years. Exclusion criteria from the trials were evaluated, and prevalence values for each excluded condition were obtained from a large wound-care population, as well as from the literature. The percentage of patients excluded on this basis was calculated.
SETTING: Seventeen RCTs testing "high-technology" wound-care products were evaluated.
PATIENTS: Patients in the trials were treated for ulcers (venous, diabetic foot, and pressure ulcers).
MAIN OUTCOME MEASURES: A percentage of patients in the study population were excluded for each RCT.
MAIN RESULTS: More than 50% of the study population would have been excluded in 15 of the 17 RCTs. When less clinically relevant exclusion criteria were removed, 14 of 17 RCTs would still have excluded between 25% and 50% of the study population.
CONCLUSION: The results raise serious questions regarding the applicability of these RCTs to wound-care populations.
The authors set out to determine the percentage of individuals that would be excluded from wound care randomized controlled trials as a surrogate for applicability to general populations.
Marissa J. Carter, PhD, is President of Strategic Solutions, Inc, Cody, Wyoming; Caroline E. Fife, MD, is Associate Professor, Department of Medicine, Division of Cardiology, The University of Texas Health Science Center, Houston, Texas; and David Walker, CHT, and Brett Thompson, BS, are CEO and President and Senior Software Engineer at Intellicure, Inc, The Woodlands, Texas.
Submitted November 19, 2008; accepted in revised form February 9, 2009.