• Chinese Academy of Medical Sciences, Peking Union Medical College, National Center for Cardiovascular Diseases, National Clinical Medical Research Center for Cardiovascular Diseases, FuWai Hospital Medical Research and Statistics Center, Beijing 100037, P. R. China;
WANG Yang, Email: wangyang@mrbc-nccd.com
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Objective To review individual treatment effect (ITE) models developed from randomized controlled trials, with the aim of systematically summarizing the current state of model development and assessing the risk of bias. Methods PubMed and Embase databases were searched for studies published between 1990 and 14 June 2024. Data were extracted using the CHARMS inventory, and the PROBAST risk of bias tool was used to assess model quality. Results A total of 11 publications were included, containing 19 ITE models. The ITE modelling methods were regression models with interaction terms (n=8, 42.1%), dual-range models (n=5, 26.3%) and machine learning (n=6, 31.6%). The ITE models had a reporting rate of 78.9%, 73.2% and 10.5% for differentiation, calibration and clinical validity, respectively. Fourteen models were assessed as having a high risk of bias (73.7%), particularly in the area of statistical analysis, due to inappropriate handling of missing data (n=15, 78.9%), inappropriate consideration of model fit issues (n=5, 26.3%), etc. Conclusion Common approaches to ITE model development include constructing interaction terms, dual procedure theory, and machine learning, but suffer from a low number of model developments, more complex modeling methods, and non-standardized reporting. In the future, emphasis should be placed on further exploration of ITE models, promoting diversified modeling methods and standardized reporting to improve the clinical promotion and practical application value of the models.