Optimizing clinical nutrition research: the role of adaptive and pragmatic trials.

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.

The Associations between Dietary Supplement Use, Diet Quality, and Health-Related Quality of Life among Older Female Cancer Survivors.

Evidence-based guidelines for cancer survivorship do not recommend dietary supplementation, yet older cancer survivors report high prevalence of dietary supplement use, specifically multivitamin (MVM), calcium, and vitamin D. Female cancer survivors (≥65 years) who were ≤5 years post-cancer diagnosis completed questionnaires assessing health-related quality of life (HRQoL), diet quality, and supplement intake. Intakes of MVM, calcium, and vitamin D supplementation were 61.4%, 76.9%, and 35.3%, respectively. Women who used MVM supplements had significantly higher dietary quality mean scores for total vegetables (4.5 ± 0.9 to 4.1 ± 1.1), greens and beans (4.1 ± 1.3 to 3.6 ± 1.6), whole fruit (4.7 ± 0.8 to 4.3 ± 1.3), and whole grains (2.9 ± 1.8 to 2.3 ± 1.6) than those who did not use these supplements. After controlling for demographic and clinical variables, the odds of MVM use was 1.07 times greater among those women who had higher total HEI scores. Participants with lower HRQoL were 4% more likely to take an MVM. Understanding the prevalence of supplementation, associations with diet quality, and perceived benefits of supplementation may help healthcare providers in educating survivors and promoting adherence to the evidence-based guidelines.