Abstract
Randomized controlled trials (RCTs) provide the best quality evidence to steer patient care in the field of clinical nutrition. However, designing and conducting an RCT, analyzing data, interpreting and reporting its findings is rather complex for young researchers working in the field of clinical nutrition. This review article attempts to educate early researchers by offering a simple step by step guide on planning the key aspects (randomization, allocation concealment, blinding, outcome measures) of a trial, and highlighting the practical considerations (ethical clearance, trial registry, patient recruitment, trial monitoring) to be kept in mind while conducting a trial contextualised to clinical nutrition settings.
Highlights
BackgroundRandomized controlled trials (RCTs) generate the best quality of evidence in clinical nutrition practice and play an instrumental role in validating any nutrition/lifestyle intervention [1]
Very few cross-cutting high-quality landmark clinical trials have been published from these countries, despite the huge scope and need for evidence-based clinical nutrition interventions in these nations [3]
RCT: randomized controlled trial e) Interim analysis: Pre-planned interim analysis by independent statisticians is helpful in early assessment of efficacy as well as safety of the nutrition/lifestyle interventions
Summary
Randomized controlled trials (RCTs) generate the best quality of evidence in clinical nutrition practice and play an instrumental role in validating any nutrition/lifestyle intervention [1]. Registered dietitians, postgraduate nutrition students, dietitians and young faculty in the field of clinical nutrition science often lack the desired training and exposure to conduct clinical trials. They are burdened with a high load of indoor as well as outdoor patient counseling, leaving them little time to focus on designing and conducting research. How to cite this article Arora C, Malhotra A, Ranjan P, et al (August 09, 2021) Designing and Conducting Randomized Controlled Trials: Basic Concepts for Educating Early Researchers in the Field of Clinical Nutrition. When evidence from other study designs suggests that an intervention might be effective, an RCT should be planned to generate stronger evidence
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