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
- Helping themselves and helping others: how the passage of time influences why mothers with addictions take part in research.
Crawford K, Russell L, Graham S, Turner F. Crawford K, et al. Front Psychiatry. 2023 Oct 4;14:1204882. doi: 10.3389/fpsyt.2023.1204882. eCollection 2023. Front Psychiatry. 2023. PMID: 37860169 Free PMC article. - Estimating the impact of stimulant use on initiation of buprenorphine and extended-release naltrexone in two clinical trials and real-world populations.
Cook RR, Foot C, Arah OA, Humphreys K, Rudolph KE, Luo SX, Tsui JI, Levander XA, Korthuis PT. Cook RR, et al. Addict Sci Clin Pract. 2023 Feb 14;18(1):11. doi: 10.1186/s13722-023-00364-3. Addict Sci Clin Pract. 2023. PMID: 36788634 Free PMC article. Clinical Trial. - Assessing trial representativeness using serious adverse events: an observational analysis using aggregate and individual-level data from clinical trials and routine healthcare data.
Hanlon P, Butterly E, Shah ASV, Hannigan LJ, Wild SH, Guthrie B, Mair FS, Dias S, Welton NJ, McAllister DA. Hanlon P, et al. BMC Med. 2022 Oct 28;20(1):410. doi: 10.1186/s12916-022-02594-9. BMC Med. 2022. PMID: 36303169 Free PMC article. - Associations Between Childhood Trauma Characteristics and Theory of Mind in Adults: Results From a Large, Diverse Sample.
Peterson CS, Zhu Y, Germine LT, Dunn EC. Peterson CS, et al. Child Psychiatry Hum Dev. 2024 Jun;55(3):719-730. doi: 10.1007/s10578-022-01442-4. Epub 2022 Sep 27. Child Psychiatry Hum Dev. 2024. PMID: 36168019 Free PMC article. - A Meta-Regression of Trial Features Predicting the Effects of Alcohol Use Disorder Pharmacotherapies on Drinking Outcomes in Randomized Clinical Trials: A Secondary Data Analysis.
Grodin EN, Donato S, Du H, Green R, Bujarski S, Ray LA. Grodin EN, et al. Alcohol Alcohol. 2022 Sep 10;57(5):589-594. doi: 10.1093/alcalc/agac004. Alcohol Alcohol. 2022. PMID: 35229869 Free PMC article. Review.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical