Evidence map›Paper›PMID 38816752›Full record

ArticleResearch integrity and peer review2024

Enhancing reporting through structure: a before and after study on the effectiveness of SPIRIT-based templates to improve the completeness of reporting of randomized controlled trial protocols.

David Blanco, Márcio Vinícius Fagundes Donadio, Aïda Cadellans-Arróniz

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Article in Research integrity and peer review, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

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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

3 authors.

David BlancoDepartment of Physiotherapy, Universitat Internacional de Catalunya, C/Josep Trueta S/N., Sant Cugat del Vallès, 08195, Barcelona, Spain. dblanco@uic.es.ORCID http://orcid.org/0000-0003-2961-9328
Márcio Vinícius Fagundes Donadio *Department of Physiotherapy, Universitat Internacional de Catalunya, C/Josep Trueta S/N., Sant Cugat del Vallès, 08195, Barcelona, Spain.ORCID http://orcid.org/0000-0001-8836-9109
Aïda Cadellans-Arróniz *Department of Physiotherapy, Universitat Internacional de Catalunya, C/Josep Trueta S/N., Sant Cugat del Vallès, 08195, Barcelona, Spain.ORCID http://orcid.org/0000-0002-6829-2201

Funding

Ministerio de Ciencia e Innovación PID2019-104830RB-I00/DOI (AEI): 10.13039/501100011033
6 · The paper itself

Abstract

backgroundDespite the improvements in the completeness of reporting of randomized trial protocols after the publication of the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines, many items remain poorly reported. This study aimed to assess the effectiveness of using SPIRIT-tailored templates for trial protocols to improve the completeness of reporting of the protocols that master's students write as part of their master's theses.

methodsBefore and after experimental study performed at the University Master's Degree in Orthopaedic Manual Physiotherapy of the Universitat Internacional de Catalunya (Barcelona, Spain). While students in the post-intervention period were instructed to use a trial protocol template that was tailored to SPIRIT, students in the pre-intervention period did not use the template. PRIMARY OUTCOME: Difference between the pre- and post-intervention periods in the mean number of adequately reported items (0-10 scale). The outcomes were evaluated independently and in duplicate by two blinded assessors. Students and their supervisors were not aware that they were part of a research project. For the statistical analysis, we used a generalized linear regression model (dependent variable: number of adequately reported items in the protocol; independent variables: intervention period, call, language).

resultsThirty-four trial protocols were included (17, pre-intervention; 17, post-intervention). Protocols produced during the post-intervention period (mean: 8.24; SD: 1.52) were more completely reported than those produced during the pre-intervention period (mean: 6.35; SD: 1.80); adjusted difference: 1.79 (95% CI: 0.58 to 3.00).

conclusionsSPIRIT-based templates could be used to improve the completeness of reporting of randomized trial protocols.

Indexed as

Clinical trial protocolMeta-researchRandomized controlled trialReporting guidelinesReporting quality

Identifiers

PMID38816752
PMCPMC11140857

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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.