Transportability From Randomized Trials to Clinical Care: On Initial HIV Treatment With Efavirenz and Suicidal Thoughts or Behaviors

Autor: Ann Marie Weideman, W. Christopher Mathews, Ellen F. Eaton, Camlin Tierney, Katie R. Mollan, Ann C. Collier, Conall O'Cleirigh, Jessie K. Edwards, Heidi M. Crane, Daniel Westreich, Steven G. Xu, Stephen R. Cole, Brian W. Pence, Angela M. Bengtson
Rok vydání: 2021
Předmět:
Adult
Cyclopropanes
Male
medicine.medical_specialty
Efavirenz
Anti-HIV Agents
Epidemiology
Population
HIV Infections
Drug Prescriptions
Suicidal Ideation
law.invention
Translational Research
Biomedical
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
medicine
Humans
030212 general & internal medicine
education
Suicidal ideation
Proportional Hazards Models
Randomized Controlled Trials as Topic
030304 developmental biology
0303 health sciences
education.field_of_study
Depression
business.industry
Incidence
Hazard ratio
HIV
Original Contribution
Antidepressive Agents
United States
Confidence interval
Benzoxazines
Observational Studies as Topic
chemistry
Alkynes
Cohort
Female
Observational study
medicine.symptom
business
Zdroj: Am J Epidemiol
ISSN: 1476-6256
0002-9262
Popis: 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.
Databáze: OpenAIRE
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