Reproducibility and Transparency Practices in a Sample of Nutrition- or Diet-Related Randomised Controlled Trial Publications: A Cross-Sectional Meta-Research †
1
UK EQUATOR Centre, NDORMS, University of Oxford, Oxford OX3 7LD, UK
2
Nutrition Department, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre 90050-170, Brazil
3
Cochrane Nutrition, Cape Town 7505, South Africa
*
Author to whom correspondence should be addressed.
†
Presented at the 14th European Nutrition Conference FENS 2023, Belgrade, Serbia, 14–17 November 2023.
Proceedings 2023, 91(1), 62; https://doi.org/10.3390/proceedings2023091062
Published: 20 November 2023
(This article belongs to the Proceedings of The 14th European Nutrition Conference FENS 2023)
Abstract
:Background and objectives: Journal articles describing randomised controlled trials (RCTs) are not optimally reported, often missing crucial details that ensure transparency and reproducibility. We aimed to estimate the frequency of reproducible and transparent research practices in a sample of recently published nutrition- or diet-related RCTs. Methods: We conducted a meta-research of nutrition- or diet-related RCTs published in journals indexed on Pubmed. We used a validated search strategy to identify eligible RCTs published between June 2021 and June 2022. Two reviewers independently screened the records retrieved by reading the titles and abstracts. Eligibility was confirmed after full text inspection. The data on the general aspects of the included RCT publications (participants, intervention, controls, outcomes, and study design) were extracted into RedCap. Research transparency and reproducibility practices included study registration, statistical analysis plan, data and analyses code sharing, conflicts of interest (CoI), authorship statements (CreditT), and whether the publication was open access. The relative frequencies for all variables were calculated, and comparisons were made between nutritional supplementation RCTs and those with other nutrition- or diet-related interventions. This meta-research is registered in the Open Science Framework (doi: 10.17605/OSF.IO/BF47G). Results: Most RCTs were single-centered (88%) with a parallel design (71%). The participants were most frequently adults (46%) or adults and elderly (23%), with some clinical condition (61%), receiving nutritional supplementation (55%) compared to other active intervention (44%) or placebo (40%). The outcomes most frequently studied were clinical (44%) or nutritional status (7%) and the frequency or severity of diseases (11%). Most RCTs were registered (81%) but did not present a statistical analysis plan (97%), data (51%), or code (97%) sharing statement. CoI statements were present in 98% RCTs, with 75% declaring no CoI. CrediT was identified in 61% RCTs and 85% were not open access publications. The practices of research transparency and reproducibility did not differ between supplementation and other nutrition- or diet-related RCTs. Conclusions: In a random sample of recently published nutrition- or diet-related RCTs, the frequency of practices of transparency and reproducibility related to statistical analysis plan and the availability of materials and code sharing are not satisfactory, while study registration and CoI were reported in most publications.
Author Contributions
Conceptualization, M.S.; methodology, M.S., F.M. and S.D.; software, F.M.; validation, F.M. and S.B.; formal analysis, F.M.; investigation, M.S., F.M., S.B. and S.D.; resources, M.S.; data curation, M.S.; writing—original draft preparation, F.M.; writing—review and editing, M.S., F.M., S.B. and S.D.; supervision, M.S.; project administration, M.S. and F.M. All authors have read and agreed to the published version of the manuscript.
Funding
This research received no external funding.
Institutional Review Board Statement
Not applicable.
Informed Consent Statement
Not applicable.
Data Availability Statement
All data used for the analyses presented here will be freely available at: https://osf.io/b38z9/.
Conflicts of Interest
All authors work at or have collaborations with the EQUATOR Network, an international initiative that seeks to improve the reliability and value of published health research by promoting transparent reporting and use of robust reporting guidelines.
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© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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MDPI and ACS Style
Schlussel, M.; Moraes, F.; Bernardes, S.; Durão, S. Reproducibility and Transparency Practices in a Sample of Nutrition- or Diet-Related Randomised Controlled Trial Publications: A Cross-Sectional Meta-Research. Proceedings 2023, 91, 62. https://doi.org/10.3390/proceedings2023091062
AMA Style
Schlussel M, Moraes F, Bernardes S, Durão S. Reproducibility and Transparency Practices in a Sample of Nutrition- or Diet-Related Randomised Controlled Trial Publications: A Cross-Sectional Meta-Research. Proceedings. 2023; 91(1):62. https://doi.org/10.3390/proceedings2023091062
Chicago/Turabian StyleSchlussel, Michael, Flavia Moraes, Simone Bernardes, and Solange Durão. 2023. "Reproducibility and Transparency Practices in a Sample of Nutrition- or Diet-Related Randomised Controlled Trial Publications: A Cross-Sectional Meta-Research" Proceedings 91, no. 1: 62. https://doi.org/10.3390/proceedings2023091062
