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

doi:10.1136/bmjopen-2022-064744

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

BMJ Open. 2022 Dec 26;12(12):e064744. doi: 10.1136/bmjopen-2022-064744.

Authors

Flávia Moraes Silva¹, Amanda Rodrigues Amorim Adegboye^{2

3}, Cintia Curioni⁴, Fabio S Gomes⁵, Gary Stephen Collins⁶, Gilberto Kac⁷, Jennifer A De Beyer⁶, Jonathan Alistair Cook⁸, Leila Cheikh Ismail^{9

10}, Matthew J Page¹¹, Neha Khandpur¹², Sarah Lamb¹³, Sally Hopewell⁸, Shona Kirtley⁶, Solange Durão¹⁴, Colby J Vorland¹⁵, Michael M Schlussel¹⁶

Affiliations

¹ Nutrition Department, UFCSPA, Porto Alegre, Brazil.
² Centre for Healthcare Research, Coventry University, Coventry, UK.
³ Centre for Agroecology, Water and Resilience, Coventry University, Coventry, UK.
⁴ Nutrition Institute, UERJ, Rio de Janeiro, Rio de Janeiro, Brazil.
⁵ Pan American Health Organization, Washington, District of Columbia, USA.
⁶ UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁷ Josué de Castro Nutrition Institute, UFRJ, Rio de Janeiro, Rio de Janeiro, Brazil.
⁸ Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics Rheumathology and Musculoskeletal Sciences, Oxford University, Oxford, UK.
⁹ Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah, UAE.
¹⁰ Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK.
¹¹ School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.
¹² Centre for Epidemiological Research in Nutrition and Health, Department of Nutrition, School of Public Health, USP, Sao Paulo, Brazil.
¹³ College of Medicine and Health, University of Exeter, Exeter, UK.
¹⁴ Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
¹⁵ Department of Applied Health Science, Indiana University School of Public Health - Bloomington, Bloomington, Indiana, USA.
¹⁶ UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK michael.schlussel@csm.ox.ac.uk.

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.

Keywords: Clinical trials; EPIDEMIOLOGY; Protocols & guidelines.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Data Collection
Diet
Humans
Nutritional Status
Periodicals as Topic*
Randomized Controlled Trials as Topic
Research Design

Abstract

Publication types

MeSH terms

Grants and funding