Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations

Flávia Moraes Silva, Amanda Rodrigues Amorim Adegboye, Cintia Curioni, Fabio S. Gomes, Gary Stephen Collins, Gilberto Kac, Jennifer A De Beyer, Jonathan Alistair Cook, Leila Cheikh Ismail, Matthew J. Page, Neha Khandpur, Sarah Lamb, Sally Hopewell, Shona Kirtley, Solange Durão, Colby J. Vorland, Michael M Schlussel

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Abstract

INTRODUCTION: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline establishes a minimum set of items to be reported in any randomised controlled trial (RCT) protocol. The Template for Intervention Description and Replication (TIDieR) reporting guideline was developed to improve the reporting of interventions in RCT protocols and results papers. Reporting completeness in protocols of diet or nutrition-related RCTs has not been systematically investigated. We aim to identify published protocols of diet or nutrition-related RCTs, assess their reporting completeness and identify the main reporting limitations remaining in this field. METHODS AND ANALYSIS: We will conduct a meta-research study of RCT protocols published in journals indexed in at least one of six selected databases between 2012 and 2022. We have run a search in PubMed, Embase, CINAHL, Web of Science, PsycINFO and Global Health using a search strategy designed to identify protocols of diet or nutrition-related RCTs. Two reviewers will independently screen the titles and abstracts of records yielded by the search in Rayyan. The full texts will then be read to confirm protocol eligibility. We will collect general study features (publication information, types of participants, interventions, comparators, outcomes and study design) of all eligible published protocols in this contemporary sample. We will assess reporting completeness in a randomly selected sample of them and identify their main reporting limitations. We will compare this subsample with the items in the SPIRIT and TIDieR statements. For all data collection, we will use data extraction forms in REDCap. This protocol is registered on the Open Science Framework (DOI: 10.17605/OSF.IO/YWEVS). ETHICS AND DISSEMINATION: This study will undertake a secondary analysis of published data and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

Original languageEnglish
Article numbere064744
JournalBMJ Open
Volume12
Issue number12
DOIs
Publication statusPublished - 26 Dec 2022

Bibliographical note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Funder

FMS received a postdoctoral fellowship from COPPETEC Foundation. MS, SK, JDB and GSC are funded by Cancer Research UK (grant C49297/A27294). MJP is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200101618). CJV has received honoraria from the Obesity Society and his university has received funds to support his research from: National Cattlemen’s Beef Association; Alliance for Potato Research and Education; the Gordon and Betty Moore Foundation; and NIH. Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.

Keywords

  • Clinical Trials
  • Data Collection
  • Diet
  • Humans
  • Nutritional Status
  • Periodicals as Topic
  • Protocols & Guidelines
  • Randomized Controlled Trials as Topic
  • Research Design
  • epidemiology

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