Influence of subject eligibility criteria on compliance with National Institutes of Health guidelines for inclusion of women, minorities, and children in treatment research

Humphreys K, Weingardt KR, Harris AH. 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. 2007 Jun 1; 31(6):988-95.

Related HSR&D Project(s)

• RCS 04-141 – Evaluating Treatment & Self-help Methods of Improving Functioning & Quality of Life Outcomes of Patients with Substance Abuse Disorders

Dimensions for VA is a web-based tool available to VA staff that enables detailed searches of published research and research projects.

If you have VA-Intranet access, click here for more information vaww.hsrd.research.va.gov/dimensions/

VA staff not currently on the VA network can access Dimensions by registering for an account using their VA email address.    Search Dimensions for VA for this citation
* Don't have VA-internal network access or a VA email address? Try searching the free-to-the-public version of Dimensions

Search for Abstract from PubMed

---

Abstract:

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.