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


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.
Humphreys
Keith
K
Veterans Affairs Health Care System and Stanford University School of Medicine, Palo Alto, California, USA. KNH@stanford.edu
Weingardt
Kenneth R
KR
Harris
Alex H S
AH
D000293:Adolescent; D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data*; D000367:Age Factors; D000437:Alcoholism / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards; D004608:Eligibility Determination / Q000592:standards*; D005260:Female; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D008297:Male; D008913:Minority Groups / Q000706:statistics & numerical data*; D015999:Multivariate Analysis; D009316:National Institutes of Health (U.S.) / Q000592:standards; D018579:Patient Selection; D012737:Sex Factors; D014481:United States