Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies
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...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2023-03-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e43537 |
| _version_ | 1797734273793392640 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Flávia Silva |
| collection | DOAJ |
| description |
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 |
| first_indexed | 2024-03-12T12:41:51Z |
| format | Article |
| id | doaj.art-e34ec79f223e41ffa9f92c85a2e164ef |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:41:51Z |
| publishDate | 2023-03-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-e34ec79f223e41ffa9f92c85a2e164ef2023-08-28T23:48:22ZengJMIR PublicationsJMIR Research Protocols1929-07482023-03-0112e4353710.2196/43537Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research StudiesFlávia Silvahttps://orcid.org/0000-0003-0730-5424Amanda Rodrigues Amorim Adegboyehttps://orcid.org/0000-0003-2780-0350Carl Lachathttps://orcid.org/0000-0002-1389-8855Cintia Curionihttps://orcid.org/0000-0002-5160-9567Fabio Gomeshttps://orcid.org/0000-0003-4997-4642Gary S Collinshttps://orcid.org/0000-0002-2772-2316Gilberto Kachttps://orcid.org/0000-0001-8603-9077Jennifer Anne de Beyerhttps://orcid.org/0000-0002-3547-4973Jonathan Cookhttps://orcid.org/0000-0002-3432-5191Leila Cheikh Ismailhttps://orcid.org/0000-0003-3048-7481Matthew Pagehttps://orcid.org/0000-0003-3706-6030Neha Khandpurhttps://orcid.org/0000-0002-4766-8361Sarah Lambhttps://orcid.org/0000-0003-4349-7195Sally Hopewellhttps://orcid.org/0000-0002-6881-6984Shona Kirtleyhttps://orcid.org/0000-0002-7801-5777Solange Durãohttps://orcid.org/0000-0001-7028-2638Colby J Vorlandhttps://orcid.org/0000-0003-4225-372XMichael M Schlusselhttps://orcid.org/0000-0002-1711-9310 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)DERR1-10.2196/43537https://www.researchprotocols.org/2023/1/e43537 |
| spellingShingle | 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 Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies JMIR Research Protocols |
| title | Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies |
| title_full | Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies |
| title_fullStr | Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies |
| title_full_unstemmed | Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies |
| title_short | Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies |
| title_sort | completeness of reporting in diet and nutrition related randomized controlled trials and systematic reviews with meta analysis protocol for 2 independent meta research studies |
| url | https://www.researchprotocols.org/2023/1/e43537 |
| work_keys_str_mv | AT flaviasilva completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT amandarodriguesamorimadegboye completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT carllachat completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT cintiacurioni completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT fabiogomes completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT garyscollins completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT gilbertokac completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT jenniferannedebeyer completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT jonathancook completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT leilacheikhismail completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT matthewpage completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT nehakhandpur completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT sarahlamb completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT sallyhopewell completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT shonakirtley completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT solangedurao completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT colbyjvorland completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies AT michaelmschlussel completenessofreportingindietandnutritionrelatedrandomizedcontrolledtrialsandsystematicreviewswithmetaanalysisprotocolfor2independentmetaresearchstudies |