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Citation |
Mollan KR, Pence BW, Xu S, Edwards JK, Mathews WC, O'Cleirigh C, Crane HM, Eaton EF, Collier AC, Weideman AMK, Westreich D, Cole SR, Tierney C, Bengtson AM, CFAR Network of Integrated Clinical Systems and the AIDS Clinical Trials Group. Am. J. Epidemiol. 2021; 190(10): 2075-2084. |
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Copyright |
(Copyright © 2021, Oxford University Press) |
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DOI |
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PMID |
33972995 |
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PMCID |
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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. Language: en |
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Keywords |
Humans; United States; Adult; Female; Male; Incidence; Depression; Randomized Controlled Trials as Topic; Proportional Hazards Models; Suicidal Ideation; suicidal ideation; Antidepressive Agents; HIV; Drug Prescriptions; efavirenz; HIV Infections; Anti-HIV Agents; Benzoxazines; multiple imputation; Observational Studies as Topic; Cyclopropanes; Alkynes; benzoxazines; inverse odds weights; new user design; Translational Research, Biomedical; transportability |