The DOI matches its Crossref record; 51 of the 51 references it cites were found in a registry or an index.
Generalizing Evidence From Randomized Clinical Trials to Target Populations: The ACTG 320 Trial
Open accessAbstract
Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results.
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Citations
Cites
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The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
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A structural approach to selection bias
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Cited by
Covariate Balancing Propensity Score
Imai, K., & Ratkovic, M. (2014) · Journal of the Royal Statistical Society Series B: Statistical Methodology · doi:10.1111/rssb.12027 · Cited by 1,315
The Table 2 Fallacy: Presenting and Interpreting Confounder and Modifier Coefficients
Westreich, D., & Greenland, S. (2013) · American Journal of Epidemiology · doi:10.1093/aje/kws412 · Cited by 1,276
Causal inference and the data-fusion problem
Bareinboim, E., & Pearl, J. (2016) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1510507113 · Cited by 621
The Use of Propensity Scores to Assess the Generalizability of Results from Randomized Trials
Stuart, E. A., Cole, S. R., Bradshaw, C. P., & Leaf, P. J. (2011) · Journal of the Royal Statistical Society Series A: Statistics in Society · doi:10.1111/j.1467-985x.2010.00673.x · Cited by 524
Self-citationGeneralizability of heterogeneous treatment effect estimates across samples
Coppock, A., Leeper, T. J., & Mullinix, K. J. (2018) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1808083115 · Cited by 445
Metadata
- Authors
- Cole, S. R., & Stuart, E. A.
- Venue
- American Journal of Epidemiology
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-06-14
- Volume
- 172
- Issue
- 1
- Pages
- 107-115
- ISSN
- 0002-9262 (ISSN-L)
- 1476-6256
- OpenAlex
- W2123846587
- Cited by
- 486
- References
- 51
- FWCI
- 7.81
- Type
- journal article
- Language
- en
- Open access
- green
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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