دورية أكاديمية
Reporting completeness of nutrition and diet-related randomised controlled trials protocols.
| العنوان: | Reporting completeness of nutrition and diet-related randomised controlled trials protocols. |
|---|---|
| المؤلفون: | Silva FM; Nutrition Department and Graduate Program of Nutrition Science, Federal University of Health Science of Porto Alegre, Brazil., Amorim Adegboye AR; Research Centre for Healthcare & Communities, Coventry University, Coventry, UK; Centre for Agroecology, Water and Resilience (CAWR), Coventry University, UK., Curioni C; Department of Nutrition in Public Health, State University of Rio de Janeiro, Brazil., Gomes F; Pan-American Health Organisation, World Health Organisation, Washington DC, USA., Collins GS; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK., Kac G; Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Brazil., Cook J; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Ismail LC; Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, P. O. Box 27272 Sharjah, United Arab Emirates; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Page MJ; Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Khandpur N; Division of Human Nutrition and Health, Washington University, Department of Nutrition, University of São Paulo, Brazil; Department of Nutrition, Harvard T.H. Chan School of Public Health, USA., Lamb S; College of Medicine and Health, University of Exeter, Exeter, UK., Hopewell S; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Saleh S; Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, P. O. Box 27272 Sharjah, United Arab Emirates., Kirtley S; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK., Bernardes S; Nutrition Department and Graduate Program of Nutrition Science, Federal University of Health Science of Porto Alegre, Brazil., Durão S; Health Systems Research Unit, South African Medical Research Council, South Africa., Vorland CJ; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, USA., Lima J; Oracle Life Sciences, São Paulo, Brazil., Rebelo F; Clinical Research Unit, National Institute of Women, Children and Adolescents Health Fernandes Figueira (IFF), Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil., Cunha Figueiredo AC; Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Brazil; Health Science Center, Serra dos Órgãos University Center, Rio de Janeiro, Brazil., Braga Tibaes JR; Department of Agricultural, Food and Nutritional Science, University of Alberta, Canada., Tavares M; Department of Nutrition in Public Health, State University of Rio de Janeiro, Brazil., da Silva Fink J; Independent Researcher, Brazil., Maia de Sousa T; Department of Nutrition in Public Health, State University of Rio de Janeiro, Brazil., Chester-Jones M; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK., Bi D; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK., Naude C; Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health. Faculty of Medicine and Health Sciences. Stellenbosch University, Cape Town, South Africa., Schlussel M; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. Electronic address: michael.schlussel@csm.ox.ac.uk. |
| المصدر: | Clinical nutrition (Edinburgh, Scotland) [Clin Nutr] 2024 Jul; Vol. 43 (7), pp. 1626-1635. Date of Electronic Publication: 2024 May 03. |
| نوع المنشور: | Journal Article; Meta-Analysis |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 8309603 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1983 (Electronic) Linking ISSN: 02615614 NLM ISO Abbreviation: Clin Nutr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2004->: Kidlington, Oxford, U.K. : Elsevier Original Publication: Edinburgh ; New York : Churchill Livingstone, c1982- |
| مواضيع طبية MeSH: | Diet* , Randomized Controlled Trials as Topic* , Clinical Trial Protocols as Topic*, Humans ; Checklist/standards ; Research Design/standards ; SARS-CoV-2 ; Editorial Policies ; Periodicals as Topic ; Guidelines as Topic |
| مستخلص: | Background and Aims: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols. Methods: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. Results: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores. Conclusions: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols. Competing Interests: Conflicts of interest Flávia Moraes Silva received a postdoctoral fellowship from COPPETEC Foundation. Michael Maia Schlussel, Shona Kirtley, Jennifer A de Beyer and Gary Collins are funded by Cancer Research UK (grant C49297/A27294). Matthew J Page is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200101618). Colby Vorland has received honoraria from The Obesity Society and the Alliance for Potato Research and Education, 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. All authors work directly or have collaborations with the EQUATOR Network, an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. (Copyright © 2024. Published by Elsevier Ltd.) |
| معلومات مُعتمدة: | 001 International WHO_ World Health Organization |
| فهرسة مساهمة: | Keywords: Intervention; Nutrition; Protocols; Randomised controlled trials; Reporting guidelines |
| تواريخ الأحداث: | Date Created: 20240525 Date Completed: 20240623 Latest Revision: 20240717 |
| رمز التحديث: | 20240717 |
| DOI: | 10.1016/j.clnu.2024.04.038 |
| PMID: | 38795681 |
| قاعدة البيانات: | MEDLINE |
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