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

      , PhD 1 , , PhD 2 , , PhD 3 , , PhD 4 , , PhD 5 , , PhD 6 , , PhD 7 , , DPhil 6 , , PhD 8 , , PhD 9 , , PhD 10 , , PhD 11 , , MSc 12 , , DPhil 8 , , MSc 6 , , MSc 13 , , PhD 14 , , PhD 6 ,
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      nutrition, diet, randomized controlled trials, CONSORT, TIDieR, PRISMA, spin, risk, bias, research, intervention, literature, limitations, PubMed

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          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.


          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.


          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.


          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.


          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.

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          The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

          The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
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            Rayyan—a web and mobile app for systematic reviews

            Background Synthesis of multiple randomized controlled trials (RCTs) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions. Filtering of searches is time consuming, and no single method fulfills the principal requirements of speed with accuracy. Automation of systematic reviews is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making. We developed Rayyan (http://rayyan.qcri.org), a free web and mobile app, that helps expedite the initial screening of abstracts and titles using a process of semi-automation while incorporating a high level of usability. For the beta testing phase, we used two published Cochrane reviews in which included studies had been selected manually. Their searches, with 1030 records and 273 records, were uploaded to Rayyan. Different features of Rayyan were tested using these two reviews. We also conducted a survey of Rayyan’s users and collected feedback through a built-in feature. Results Pilot testing of Rayyan focused on usability, accuracy against manual methods, and the added value of the prediction feature. The “taster” review (273 records) allowed a quick overview of Rayyan for early comments on usability. The second review (1030 records) required several iterations to identify the previously identified 11 trials. The “suggestions” and “hints,” based on the “prediction model,” appeared as testing progressed beyond five included studies. Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements. The survey respondents reported 40% average time savings when using Rayyan compared to others tools, with 34% of the respondents reporting more than 50% time savings. In addition, around 75% of the respondents mentioned that screening and labeling studies as well as collaborating on reviews to be the two most important features of Rayyan. As of November 2016, Rayyan users exceed 2000 from over 60 countries conducting hundreds of reviews totaling more than 1.6M citations. Feedback from users, obtained mostly through the app web site and a recent survey, has highlighted the ease in exploration of searches, the time saved, and simplicity in sharing and comparing include-exclude decisions. The strongest features of the app, identified and reported in user feedback, were its ability to help in screening and collaboration as well as the time savings it affords to users. Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of reviewers.
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              Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

              Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                23 March 2023
                : 12
                : e43537
                [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
                Author notes
                Corresponding Author: Michael M Schlussel michaelmaia@ 123456gmail.com
                Author information
                ©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.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 14 October 2022
                : 17 January 2023
                : 29 January 2023
                : 29 January 2023

                nutrition,diet,randomized controlled trials,consort,tidier,prisma,spin,risk,bias,research,intervention,literature,limitations,pubmed


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