Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network

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Abstract

Aims: To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design. Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set—Admissions (TEDS-A). Settings. Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. Participants: A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements. The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings. The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001. Conclusions: In the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings.

Original languageEnglish (US)
Pages (from-to)1226-1234
Number of pages9
JournalAddiction
Volume111
Issue number7
DOIs
StatePublished - Jul 1 2016

Keywords

  • Clinical trials
  • sample representativeness
  • substance use disorders

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health

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