Causal Inference Guidelines for Pragmatic Clinical Trials [Methods Study], United States, 2015-2020

In randomized controlled trials, or RCTs, researchers assign patients by chance to different treatments to compare the benefits and harms. In RCTs, researchers have a high level of control over how patients receive treatment. RCTs often take place in research clinics with staff who monitor how patients follow treatment plans. Pragmatic RCTs, or pRCTs, take place where patients typically receive treatment, such as a regular clinic. pRCTs can help capture the real-world effects of treatment but determining whether a treatment works can be hard in pRCTs. Also, no clear guidance exists about how to collect and analyze data from pRCTs. Some kinds of analysis are better for helping researchers focus on what's important to patients. In this study, the research team created guidance for collecting and analyzing data in pRCTs so that results reflect what matters to patients and researchers. To access the methods and software, please visit the following Github repositories: CDP-analysis-2018 GFORMULA-RCT-SAS IV-Bounds CHARM_reanalysis Adherence_LRCCPPT