Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies - PubMed (original) (raw)
Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies
K Humphreys et al. Am J Psychiatry. 2000 Apr.
Abstract
Objective: Researchers have not systematically examined how exclusion criteria used in selection of research subjects affect the generalizability of treatment outcome research. This study evaluated the use of exclusion criteria in alcohol treatment outcome research and its effects on the comparability of research subjects with real-world individuals seeking alcohol treatment.
Method: Eight of the most common exclusion criteria described in the alcohol treatment research literature were operationalized and applied to large, representative clinical patient samples from the public and private sectors to determine whether the hypothetical research samples differed substantially from real-world samples. Five hundred ninety-three consecutive individuals seeking alcohol treatment at one of eight treatment programs participated. A trained research technician gathered information from participants on demographic variables and on alcohol, drug, and psychiatric problems as measured by the Addiction Severity Index.
Results: Large proportions of potential research subjects were excluded under most of the criteria tested. The overall pattern of results showed that African Americans, low-income individuals, and individuals who had more severe alcohol, drug, and psychiatric problems were disproportionately excluded under most criteria.
Conclusions: Exclusion criteria can result in alcohol treatment outcome research samples that are more heavily composed of white, economically stable, and higher-functioning individuals than are real-world samples of substance abuse patients seen in clinical practice, potentially compromising the generalizability of results. For both scientific and ethical reasons, in addition to studies that use exclusion criteria, outcome research that uses no or minimal exclusion criteria should be conducted so that alcohol treatment outcome research can be better generalized to vulnerable populations.
Similar articles
- Implications of Eligibility Criteria on the Generalizability of Alcohol and Drug Treatment Outcome Research: A Study of Real-World Treatment Seekers in Sweden and in Australia.
Storbjörk J, Garfield JB, Larner A. Storbjörk J, et al. Subst Use Misuse. 2017 Mar 21;52(4):439-450. doi: 10.1080/10826084.2016.1240695. Epub 2016 Nov 16. Subst Use Misuse. 2017. PMID: 27849416 - Exclusion criteria in treatment research on alcohol, tobacco and illicit drug use disorders: A review and critical analysis.
Moberg CA, Humphreys K. Moberg CA, et al. Drug Alcohol Rev. 2017 May;36(3):378-388. doi: 10.1111/dar.12438. Epub 2016 Jun 21. Drug Alcohol Rev. 2017. PMID: 27324921 Review. - Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice?
Zimmerman M, Mattia JI, Posternak MA. Zimmerman M, et al. Am J Psychiatry. 2002 Mar;159(3):469-73. doi: 10.1176/appi.ajp.159.3.469. Am J Psychiatry. 2002. PMID: 11870014 - Generalizability of clinical trials for alcohol dependence to community samples.
Blanco C, Olfson M, Okuda M, Nunes EV, Liu SM, Hasin DS. Blanco C, et al. Drug Alcohol Depend. 2008 Nov 1;98(1-2):123-8. doi: 10.1016/j.drugalcdep.2008.05.002. Epub 2008 Jun 24. Drug Alcohol Depend. 2008. PMID: 18579319 Free PMC article. - Prevalence and predictors of research participant eligibility criteria in alcohol treatment outcome studies, 1970-98.
Humphreys K, Weingardt KR, Horst D, Joshi AA, Finney JW. Humphreys K, et al. Addiction. 2005 Sep;100(9):1249-57. doi: 10.1111/j.1360-0443.2005.01175.x. Addiction. 2005. PMID: 16128714 Review.
Cited by
- Dynamic association between negative affect and alcohol lapses following alcohol treatment.
Witkiewitz K, Villarroel NA. Witkiewitz K, et al. J Consult Clin Psychol. 2009 Aug;77(4):633-44. doi: 10.1037/a0015647. J Consult Clin Psychol. 2009. PMID: 19634957 Free PMC article. - Methodological Innovation to Increase the Utility and Efficiency of Psychotherapy Research for Patients with Co-occurring Mental Health and Substance Use Disorders.
Hien DA, Cohen LR, Campbell AN. Hien DA, et al. Prof Psychol Res Pr. 2009 Oct 1;40(5):502-509. doi: 10.1037/a0014966. Prof Psychol Res Pr. 2009. PMID: 20072727 Free PMC article. - Are adolescent treatment studies of eating disorders utilizing clinically relevant samples? A comparison of RCT and clinic treatment-seeking youth with eating disorders.
Stiles-Shields C, Goldschmidt AB, Lock J, Le Grange D. Stiles-Shields C, et al. Eur Eat Disord Rev. 2013 Sep;21(5):420-4. doi: 10.1002/erv.2228. Epub 2013 Mar 11. Eur Eat Disord Rev. 2013. PMID: 23483619 Free PMC article. - Treatment outcomes for women with substance abuse and PTSD who have experienced complex trauma.
Cohen LR, Hien DA. Cohen LR, et al. Psychiatr Serv. 2006 Jan;57(1):100-6. doi: 10.1176/appi.ps.57.1.100. Psychiatr Serv. 2006. PMID: 16399969 Free PMC article. - Advancing implementation frameworks with a mixed methods case study in child behavioral health.
Barwick M, Barac R, Kimber M, Akrong L, Johnson SN, Cunningham CE, Bennett K, Ashbourne G, Godden T. Barwick M, et al. Transl Behav Med. 2020 Aug 7;10(3):685-704. doi: 10.1093/tbm/ibz005. Transl Behav Med. 2020. PMID: 30698775 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical