Assessing the applicability of obstetrical randomized controlled trials in real-world practices

Abstract

This article examines the applicability of obstetrical randomized controlled trials (RCTs) in the real-world and proposes a classification of the value of these trials based on their potential for achieving sustainable practices. In the context of this discussion, real-world results pertain to the potential impact of the RCT on sustainable interventions and practices, and its implications for healthcare practice or policy, in the country (or countries) that was conducted. While RCTs are generally regarded as the gold standard of medical evidence, their effectiveness in producing meaningful real-world results depends, among various other factors, on the clarity and specificity of the trial definitions used for diagnosis (characteristics of the study group or enrollment criteria) and treatment (intervention). The definitions used for diagnosis and treatment, especially in pragmatic trials, can influence the likelihood for real-world implementation. By analyzing notable obstetrical RCTs, the authors find that trials with well-defined diagnoses and treatments that can be implemented without specialized expertise are more likely to generate results that are relevant to general practice, indicating higher value. In contrast, RCTs with ambiguous or undefined diagnoses and treatments often lead to variations in practice and produce unreliable real-world outcomes and practices suggesting lower value. Recognizing this variability can offer valuable guidance for the design and evaluation of RCTs in obstetrics.

Keywords:

• Randomized controlled trials
• real-world practices
• classification
• value-based
• taxonomy

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

Dr. Ananth is supported, in part, by the National Heart, Lung, and Blood Institute (grant R01-HL150065) and the National Institute of Environmental Health Sciences (grant R01-ES033190).