Grant Abstract: Cochrane Complementary Medicine Field: Resource for Research

Grant Number: 3R24AT001293-17
PI Name: Berman
Project Title: Cochrane Complementary Medicine Field: Resource for Research

Abstract: There is evidence that the reporting quality of publications of dietary supplement trials, with regard to description of supplement constituents, their handling, and other key elements (e.g., adequate characterization of baseline blood levels or dietary intake) is flawed and inconsistent. Detailed reporting recommendations tailored to randomized controlled trials of dietary supplement interventions do not exist. Cochrane Complementary Medicine at the University of Maryland School of Medicine is funded by NCCIH to be a resource for the production and dissemination of high-quality research evidence in complementary and integrative medicine, including dietary supplements. We have observed that the lack of relevant reported information in many randomized controlled trials of dietary supplement interventions represents a fundamental barrier to the understanding and usability of the research that was conducted. This limits the usefulness of the trials, and the systematic reviews which include those trials, to inform consumers and clinicians about the effectiveness and safety of dietary supplement interventions and represents a form of research waste. We propose to address this issue by partnering with key experts in the field of nutrition and dietary supplements and a research group experienced in developing reporting guidelines to carry out the groundwork for a comprehensive reporting guidance document. We will conduct a literature search and summary and engage a broad range of experts in the field to: 1) systematically identify the current gaps in reporting of dietary supplement trials; 2) generate recommendations for the important elements to be reported in trials of dietary supplements; and 3) develop plans for producing a full guidance document for the reporting of dietary supplement trials. This will directly support Goal 3 of the Office of Dietary Supplements (ODS) Strategic Plan for 2018-2021, namely to foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research [1]. PUBLIC HEALTH RELEVANCE: : This project aims to support development of comprehensive guidance for the reporting of clinical trials evaluating the benefits and harms of dietary supplements. A team of methodological and content experts will work with a broad range of stakeholders to: 1) systematically identify the current gaps in reporting of dietary supplement trials; 2) generate recommendations for the important elements to be reported in trials of dietary supplements; and 3) develop plans for producing a full guidance document for the reporting of dietary supplement trials. This will directly support Goal 3 of the Office of Dietary Supplements (ODS) Strategic Plan for 2018-2021, namely to foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research.

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