Evidence map›Paper›PMID 36572499›Full record

ArticleBMJ open2022

Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations.

Flávia Moraes Silva, Amanda Rodrigues Amorim Adegboye, Cintia Curioni, Fabio S Gomes, Gary Stephen Collins, Gilberto Kac, Jennifer A De Beyer, Jonathan Alistair Cook, Leila Cheikh Ismail, Matthew J Page and 7 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

17 authors.

Flávia Moraes SilvaNutrition Department, UFCSPA, Porto Alegre, Brazil.ORCID 0000-0003-0730-5424
Amanda Rodrigues Amorim AdegboyeCentre for Healthcare Research, Coventry University, Coventry, UK.
Cintia CurioniNutrition Institute, UERJ, Rio de Janeiro, Rio de Janeiro, Brazil.ORCID 0000-0002-5160-9567
Fabio S GomesPan American Health Organization, Washington, District of Columbia, USA.ORCID 0000-0003-4997-4642
Gary Stephen CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-2772-2316
Gilberto KacJosué de Castro Nutrition Institute, UFRJ, Rio de Janeiro, Rio de Janeiro, Brazil.
Jennifer A De BeyerUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Jonathan Alistair CookOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics Rheumathology and Musculoskeletal Sciences, Oxford University, Oxford, UK.ORCID 0000-0002-4156-6989
Leila Cheikh IsmailDepartment of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah, UAE.
Matthew J PageSchool of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.ORCID 0000-0002-4242-7526
Neha KhandpurCentre for Epidemiological Research in Nutrition and Health, Department of Nutrition, School of Public Health, USP, Sao Paulo, Brazil.
Sarah LambCollege of Medicine and Health, University of Exeter, Exeter, UK.
Sally HopewellOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics Rheumathology and Musculoskeletal Sciences, Oxford University, Oxford, UK.
Shona KirtleyUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Solange DurãoCochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
Colby J VorlandDepartment of Applied Health Science, Indiana University School of Public Health - Bloomington, Bloomington, Indiana, USA.
Michael M SchlusselUK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Reumathology and Musculoskeletal Sciences, University of Oxford, Oxford, UK michael.schlussel@csm.ox.ac.uk.ORCID 0000-0002-1711-9310

Funding

Cancer Research UK 27294Cancer Research UK C49297/A27294
6 · The paper itself

Abstract

introductionThe Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline establishes a minimum set of items to be reported in any randomised controlled trial (RCT) protocol. The Template for Intervention Description and Replication (TIDieR) reporting guideline was developed to improve the reporting of interventions in RCT protocols and results papers. Reporting completeness in protocols of diet or nutrition-related RCTs has not been systematically investigated. We aim to identify published protocols of diet or nutrition-related RCTs, assess their reporting completeness and identify the main reporting limitations remaining in this field. METHODS AND ANALYSIS: We will conduct a meta-research study of RCT protocols published in journals indexed in at least one of six selected databases between 2012 and 2022. We have run a search in PubMed, Embase, CINAHL, Web of Science, PsycINFO and Global Health using a search strategy designed to identify protocols of diet or nutrition-related RCTs. Two reviewers will independently screen the titles and abstracts of records yielded by the search in Rayyan. The full texts will then be read to confirm protocol eligibility. We will collect general study features (publication information, types of participants, interventions, comparators, outcomes and study design) of all eligible published protocols in this contemporary sample. We will assess reporting completeness in a randomly selected sample of them and identify their main reporting limitations. We will compare this subsample with the items in the SPIRIT and TIDieR statements. For all data collection, we will use data extraction forms in REDCap. This protocol is registered on the Open Science Framework (DOI: 10.17605/OSF.IO/YWEVS). ETHICS AND DISSEMINATION: This study will undertake a secondary analysis of published data and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

Indexed as

Periodicals as TopicData CollectionDietHumansNutritional StatusRandomized Controlled Trials as TopicResearch DesignClinical trialsEPIDEMIOLOGYProtocols & guidelines

Identifiers

PMID36572499
PMCPMC9806013

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.