Evidence-based nutritional recommendations address the health impact of suboptimal nutritional status. Efficacy randomized controlled trials (RCTs) have traditionally been the preferred method for determining the effects of nutritional interventions on health outcomes. Nevertheless, obtaining a holistic understanding of intervention efficacy and effectiveness in real-world settings is stymied by inherent constraints of efficacy RCTs. These limitations are further compounded by the complexity of nutritional interventions and the intricacies of the clinical context. Herein, we explore the advantages and limitations of alternative study designs (e.g., adaptive and pragmatic trials), which can be incorporated into RCTs to optimize the efficacy or effectiveness of interventions in clinical nutrition research. Efficacy RCTs often lack external validity due to their fixed design and restrictive eligibility criteria, leading to efficacy-effectiveness and evidence-practice gaps. Adaptive trials improve the evaluation of nutritional intervention efficacy through planned study modifications, such as recalculating sample sizes or discontinuing a study arm. Pragmatic trials are embedded within clinical practice or conducted in settings that resemble standard of care, enabling a more comprehensive assessment of intervention effectiveness. Pragmatic trials often rely on patient-oriented primary outcomes, acquire outcome data from electronic health records, and employ broader eligibility criteria. Consequently, adaptive and pragmatic trials facilitate the prompt implementation of evidence-based nutritional recommendations into clinical practice. Recognizing the limitations of efficacy RCTs and the potential advantages of alternative trial designs is essential for bridging efficacy-effectiveness and evidence-practice gaps. Ultimately, this awareness will lead to a greater number of patients benefiting from evidence-based nutritional recommendations.
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This research received no specific grant from any funding agency, commercial or not-for-profit sectors. CMP was funded by as a Campus Alberta Innovation Program Chair in Nutrition, Food, and Health. Support for time for JHR was provided by National Institutes of Health MERIT award (R37CA218118) and by the Nutrition Shared Resource through the National Cancer Institute Cancer Center support grant (P30 CA16852); the contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
CEO has received honoraria from Abbott Nutrition. CMP has previously received honoraria and/or paid consultancy from Abbott Nutrition, Nutricia, Nestlé Health Science, Fresenius Kabi, AMRA Medical, and Pfizer. NK has received honoraria and/or paid consultancy from Abbott Australasia. KLF, EBT, CKS, JHR—no conflicts of interest.
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Orsso, C.E., Ford, K.L., Kiss, N. et al. Optimizing clinical nutrition research: the role of adaptive and pragmatic trials. Eur J Clin Nutr 77, 1130–1142 (2023). https://doi.org/10.1038/s41430-023-01330-7