JMIR Publications

ABSTRACT

Background:

It is well-known that journal articles describing randomized clinical trials (RCTs) and systematic reviews with meta-analyses of RCTs are not optimally reported, but instead 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.

Objective:

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.

Methods:

Two independent meta-research studies will be conducted using articles published in peer-reviewed journals. The first will include a sample of diet- and nutrition-related RCTs. The second will include a sample of systematic reviews with meta-analyses of diet- and nutrition-related RCTs. We will use a search strategy validated 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 one calendar year and randomly select 100 RCTs and 100 meta-analyses. Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. We will extract the general features of these published RCTs and meta-analyses into a RedCap database. We will assess the completeness of reporting of each RCT using the items in the Consolidated Standards of Reporting Trials (CONSORT), its extensions, and the Template for Intervention Description and Replication (TIDieR) statements. We will collect information about practices that promote research transparency and reproducibility, such as publication of protocols and statistical analysis plans. We will assess 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 collect information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These two meta-research studies are registered in the Open Science Framework (doi: 10.17605/OSF.IO/BF47G and 10.17605/OSF.IO/ZTFYX).

Results:

The literature search for the first meta-research retrieved 20,030 records and 2,259 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible.Among them a random sample of 100 RCT and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress and completion is expected by the end of 2022.

Conclusions:

Our meta-research studies will summarize the main limitation on completeness reporting of nutrition or die-related RCTs and meta-analysis and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field.