This study was supported by grants from the National Institute on Alcohol Abuse and Alcoholism and the Department of Veterans Affairs Health Services Research and Development Service.
Influence of Subject Eligibility Criteria on Compliance With National Institutes of Health Guidelines for Inclusion of Women, Minorities, and Children in Treatment Research
Article first published online: 11 APR 2007
Alcoholism: Clinical and Experimental Research
Volume 31, Issue 6, pages 988–995, June 2007
How to Cite
Humphreys, K., Weingardt, K. R. and Harris, A. H. S. (2007), Influence of Subject Eligibility Criteria on Compliance With National Institutes of Health Guidelines for Inclusion of Women, Minorities, and Children in Treatment Research. Alcoholism: Clinical and Experimental Research, 31: 988–995. doi: 10.1111/j.1530-0277.2007.00391.x
- Issue published online: 4 MAY 2007
- Article first published online: 11 APR 2007
- Received for publication September 26, 2006; accepted February 9, 2007.
- Alcohol Dependence;
- Health Services Research;
- Treatment Outcome;
- Minority Health;
- Women's Health
Background: Many alcohol treatment outcome studies exclude some patients with particular problems, such as psychiatric disorders, noncompliance, and homelessness. Such criteria may increase the likelihood of a study being successfully conducted, but may also have the unintended consequence of reducing a study's ability to comply with National Institutes of Health guidelines for inclusion of racial minorities, women, and children in treatment research.
Methods and Results: This paper examined this issue empirically using 5 prior studies of treatment systems enrolling over 100,000 alcohol patients. Widely used eligibility criteria in the alcohol treatment field typically exclude between one-fifth to one-third of patients from enrolling in research. Under several eligibility criteria, most notably those for drug use and social/residential instability, women and African-American patients are substantially more likely to be excluded than are men and non–African-American patients, respectively.
Conclusions: In designing treatment studies with many eligibility criteria, researchers may therefore inadvertently be thwarting their own good faith efforts to ensure that a range of vulnerable populations are able to participate in research. We analyze the implications of this dilemma for the generalizability of treatment results and for research design, and provide data that may help researchers working in different treatment systems estimate the impact of various eligibility criteria.