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- Title
Transportability From Randomized Trials to Clinical Care: On Initial HIV Treatment With Efavirenz and Suicidal Thoughts or Behaviors.
- Authors
Mollan, Katie R; Pence, Brian W; Xu, Steven; Edwards, Jessie K; Mathews, W Christopher; O'Cleirigh, Conall; Crane, Heidi M; Eaton, Ellen F; Collier, Ann C; Weideman, Ann Marie K; Westreich, Daniel; Cole, Stephen R; Tierney, Camlin; Bengtson, Angela M; Group, for the CFAR Network of Integrated Clinical Systems and the AIDS Clinical Trials
- Abstract
In an analysis of randomized trials, use of efavirenz for treatment of human immunodeficiency virus (HIV) infection was associated with increased suicidal thoughts/behaviors. However, analyses of observational data have found no evidence of increased risk. To assess whether population differences might explain this divergence, we transported the effect of efavirenz use from these trials to a specific target population. Using inverse odds weights and multiple imputation, we transported the effect of efavirenz on suicidal thoughts/behaviors in these randomized trials (participants were enrolled in 2001–2007) to a trials-eligible cohort of US adults initiating antiretroviral therapy while receiving HIV clinical care at medical centers between 1999 and 2015. Overall, 8,291 cohort participants and 3,949 trial participants were eligible. Prescription of antidepressants (19% vs. 13%) and injection drug history (16% vs. 10%) were more frequent in the cohort than in the trial participants. Compared with the effect in trials, the estimated hazard ratio for efavirenz on suicidal thoughts/behaviors was attenuated in our target population (trials: hazard ratio (HR) = 2.3 (95% confidence interval (CI): 1.2, 4.4); transported: HR = 1.8 (95% CI: 0.9, 4.4)), whereas the incidence rate difference was similar (trials: HR = 5.1 (95% CI: 1.6, 8.7); transported: HR = 5.4 (95% CI: −0.4, 11.4)). In our target population, there was greater than 20% attenuation of the hazard ratio estimate as compared with the trials-only estimate. Transporting results from trials to a target population is informative for addressing external validity.
- Subjects
UNITED States; HIV infections; EFAVIRENZ; ANTIDEPRESSANTS; CONFIDENCE intervals; SCIENTIFIC observation; RESEARCH methodology; SUICIDAL ideation; RANDOMIZED controlled trials; DESCRIPTIVE statistics
- Publication
American Journal of Epidemiology, 2021, Vol 190, Issue 10, p2075
- ISSN
0002-9262
- Publication type
Article
- DOI
10.1093/aje/kwab136