Evidence map›Paper›PMID 36951931›Full record

ArticleJMIR research protocols2023

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 and 8 more

Abstract read
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Flávia SilvaNutrition Department, Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA, Porto Alegre, Brazil.ORCID https://orcid.org/0000-0003-0730-5424
Amanda Rodrigues Amorim AdegboyeCentre for Healthcare Research, Coventry University, Coventry, United Kingdom.ORCID https://orcid.org/0000-0003-2780-0350
Carl LachatDepartment of Food Technology, Safety and Health, Ghent University, Ghent, Belgium.ORCID https://orcid.org/0000-0002-1389-8855
Cintia CurioniDepartment of Nutrition in Public Health, State University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID https://orcid.org/0000-0002-5160-9567
Fabio GomesPan-American Health Organization, World Health Organization, Washington, WA, United States.ORCID https://orcid.org/0000-0003-4997-4642
Gary S CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-2772-2316
Gilberto KacNutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID https://orcid.org/0000-0001-8603-9077
Jennifer Anne de BeyerUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-3547-4973
Jonathan CookOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-3432-5191
Leila Cheikh IsmailDepartment of Clinical Nutrition and Dietetics, College of Health Sciences, Sharjah, United Arab Emirates.ORCID https://orcid.org/0000-0003-3048-7481
Matthew PageMethods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.ORCID https://orcid.org/0000-0003-3706-6030
Neha KhandpurDivision of Human Nutrition and Health, Wageningen University and Research, Wageningen, Netherlands.ORCID https://orcid.org/0000-0002-4766-8361
Sarah LambCollege of Medicine and Health, University of Exeter, Exeter, United Kingdom.ORCID https://orcid.org/0000-0003-4349-7195
Sally HopewellOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-6881-6984
Shona KirtleyUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-7801-5777
Solange DurãoCochrane South Africa, South African Medical Research Council, South Africa, Cape Town, South Africa.ORCID https://orcid.org/0000-0001-7028-2638
Colby J VorlandDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, United States.ORCID https://orcid.org/0000-0003-4225-372X
Michael M SchlusselUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-1711-9310

Funding

Cancer Research UK 27294World Health Organization 001
6 · The paper itself

Abstract

backgroundJournal 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.

objectiveWe 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.

methodsTwo 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.

resultsThe 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.

conclusionsOur 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.

Indexed as

biasCONSORTdietinterventionlimitationsliteraturenutritionPRISMAPubMedrandomized controlled trialsresearchriskspinTIDieR

Identifiers

PMID36951931
PMCPMC10131600

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.