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
Shona Kirtley,
Sally Hopewell,
Solange Durão,
Matthew J Page,
Sarah Lamb,
Leila Cheikh Ismail,
Jonathan Alistair Cook,
Cintia Curioni,
Neha Khandpur,
Gilberto Kac,
Gary Stephen Collins,
Fabio S Gomes,
Flávia Moraes Silva,
Amanda Rodrigues Amorim Adegboye,
Jennifer A De Beyer,
Colby J Vorland,
Michael M Schlussel
Affiliations
Shona Kirtley
senior research information specialist
Sally Hopewell
professor of clinical trials and evidence synthesis
Solange Durão
Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa
Matthew J Page
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Sarah Lamb
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Leila Cheikh Ismail
7 Clinical Nutrition and Dietetics Department, University of Sharjah College of Health Sciences, Sharjah, UAE
Jonathan Alistair Cook
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics Rheumathology and Musculoskeletal Sciences, Oxford University, Oxford, UK
Cintia Curioni
assistant professor
Neha Khandpur
Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA
Gilberto Kac
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
Gary Stephen Collins
UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Fabio S Gomes
Noncommunicable Diseases and Mental Health, Pan American Health Organization, Washington DC, District of Columbia, USA
Flávia Moraes Silva
Nutrition Department, UFCSPA, Porto Alegre, Brazil
Amanda Rodrigues Amorim Adegboye
Centre for Healthcare Research, Coventry University, Coventry, UK
Jennifer A De Beyer
UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Colby J Vorland
Department of Applied Health Science, Indiana University School of Public Health - Bloomington, Bloomington, Indiana, USA
Michael M Schlussel
UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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.
