Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies

Flávia Silva; Amanda Rodrigues Amorim Adegboye; Carl Lachat; Cintia Curioni; Fabio Gomes; Gary S Collins; Gilberto Kac; Jennifer Anne de Beyer; Jonathan Cook; Leila Cheikh Ismail; Matthew Page; Neha Khandpur; Sarah Lamb; Sally Hopewell; Shona Kirtley; Solange Durão; Colby J Vorland; Michael M Schlussel

doi:10.2196/43537

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies

JMIR Res Protoc. 2023 Mar 23:12:e43537. doi: 10.2196/43537.

Authors

Flávia Silva¹, Amanda Rodrigues Amorim Adegboye², Carl Lachat³, Cintia Curioni⁴, Fabio Gomes⁵, Gary S Collins⁶, Gilberto Kac⁷, Jennifer Anne de Beyer⁶, Jonathan Cook⁸, Leila Cheikh Ismail⁹, Matthew Page¹⁰, Neha Khandpur¹¹, Sarah Lamb¹², Sally Hopewell⁸, Shona Kirtley⁶, Solange Durão¹³, Colby J Vorland¹⁴, Michael M Schlussel⁶

Affiliations

¹ Nutrition Department, Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA, Porto Alegre, Brazil.
² Centre for Healthcare Research, Coventry University, Coventry, United Kingdom.
³ Department of Food Technology, Safety and Health, Ghent University, Ghent, Belgium.
⁴ Department of Nutrition in Public Health, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
⁵ Pan-American Health Organization, World Health Organization, Washington, WA, United States.
⁶ UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
⁷ Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
⁸ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
⁹ Department of Clinical Nutrition and Dietetics, College of Health Sciences, Sharjah, United Arab Emirates.
¹⁰ Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
¹¹ Division of Human Nutrition and Health, Wageningen University and Research, Wageningen, Netherlands.
¹² College of Medicine and Health, University of Exeter, Exeter, United Kingdom.
¹³ Cochrane South Africa, South African Medical Research Council, South Africa, Cape Town, South Africa.
¹⁴ Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, United States.

PMID: 36951931
PMCID: PMC10131600
DOI: 10.2196/43537

Abstract

Background: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies' risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored.

Objective: We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses.

Methods: Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework.

Results: The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023.

Conclusions: Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field.

International registered report identifier (irrid): DERR1-10.2196/43537.

Keywords: CONSORT; PRISMA; PubMed; TIDieR; bias; diet; intervention; limitations; literature; nutrition; randomized controlled trials; research; risk; spin.

©Flávia Silva, Amanda Rodrigues Amorim Adegboye, Carl Lachat, Cintia Curioni, Fabio Gomes, Gary S Collins, Gilberto Kac, Jennifer Anne de Beyer, Jonathan Cook, Leila Cheikh Ismail, Matthew Page, Neha Khandpur, Sarah Lamb, Sally Hopewell, Shona Kirtley, Solange Durão, Colby J Vorland, Michael M Schlussel. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.03.2023.

Abstract

Grants and funding