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ARTICLE

Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There?

Cary P. Gross, MD; Raburn Mallory, MD; Asefeh Heiat, MD; and Harlan M. Krumholz, MD

2 July 2002 | Volume 137 Issue 1 | Pages 10-16

Background: A common criticism of randomized, controlled trials (RCTs) is that the enrollment process may be highly selective and those who enroll may not represent persons in the general population. The recruitment process reported in published RCTs has not been systematically evaluated.

Objective: To determine whether published RCTs report information about how their study sample was assembled and to describe the proportion of potential study participants who were actually enrolled.

Design: Cross-sectional explicit review of RCTs published in four high-impact medical journals between 1 April 1999 and 1 April 2000. All RCTs involved interventions in humans.

Measurements: The number of persons who were screened for eligibility, the number who were eligible, and the number who were enrolled in each RCT.

Results: A total of 172 RCTs were reviewed. Ninety (52%) reported the number of persons who were evaluated by the investigators for eligibility, and 74 (43%) reported the number of persons who were actually eligible for participation. Of the studies that reported quantitative recruitment information, the median proportion of screened persons who were eligible for participation was 65% (interquartile range, 41% to 82%) and the median proportion of eligible persons who enrolled was 93% (interquartile range, 79% to 100%). Some trials reportedly enrolled every person screened for eligibility; others screened as many as 68 people for each person finally enrolled.

Conclusions: Many RCTs published in major medical journals do not provide information about the patient recruitment process. As a result, it is difficult for readers to gauge the extent to which participants may represent a highly selected subgroup.

Editors' Notes Context The value of randomized, controlled trials often depends on generalizability of the findings. However, persons recruited for these studies may not be representative of the population of interest. Contribution Randomized, controlled trials recently published in four high-impact medical journals were reviewed to evaluate the recruitment process. Only half of the trials reported the number of persons who were evaluated for eligibility, and 43% reported how many were actually eligible. The proportion of screened potential participants who were eligible and actually enrolled varied widely. Implications Because the patient recruitment process is often poorly delineated, it is difficult to judge the generalizability of findings reported in many randomized, controlled trials. –The Editors

 

Author and Article Information

From Yale University School of Medicine and Yale–New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut; and Louis Stokes–Cleveland Department of Veterans Affairs Medical Center, Youngstown, Ohio.

Acknowledgment: The authors thank Dr. Anna Reisman for her thoughtful comments.

Grant Support: Dr. Gross is supported in part by a Cancer Prevention, Control and Population Sciences Career Development Award (1K07CA-90402).

Requests for Single Reprints: Cary P. Gross, MD, Yale University School of Medicine, Primary Care Center, PO Box 208025, 333 Cedar Street, New Haven, CT 06520; e-mail, cary.gross{at}yale.edu.

Current Author Addresses: Dr. Gross: Yale University School of Medicine, Primary Care Center, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Dr. Mallory: Yale University School of Medicine, Department of Medicine, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Dr. Heiat: Louis Stokes–Cleveland Department of Veteran's Affairs Medical Center, Youngstown Outpatient Clinic, 2031 Belmont Avenue, Youngstown, OH 44505.

Dr. Krumholz: Yale University School of Medicine, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Author Contributions: Conception and design: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Analysis and interpretation of the data: C.P. Gross. Drafting of the article: C.P. Gross, A. Heiat, H. Krumholz.

Critical revision of the article for important intellectual content: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Final approval of the article: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Administrative, technical, or logistic support: C.P. Gross.

Collection and assembly of data: C.P. Gross, R. Mallory, A. Heiat.

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