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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
dc.contributor.author | Blanco, David | |
dc.contributor.author | Fagundes, Vinícius | |
dc.contributor.author | Cadellans Arróniz, Aida | |
dc.date.accessioned | 2024-07-16T11:48:14Z | |
dc.date.available | 2024-07-16T11:48:14Z | |
dc.date.issued | 2024 | |
dc.identifier.citation | Blanco, David; Fagundes, Vinícius; Cadellans Arróniz, Aida. 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. Research Integrity and Peer Review, 2024, 9, 6. Disponible en: <https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-024-00147-7>. Fecha de acceso: 16 jul. 2024. DOI: 10.1186/s41073-024-00147-7 | ca |
dc.identifier.issn | 2058-8615 | ca |
dc.identifier.uri | http://hdl.handle.net/20.500.12328/4308 | |
dc.description.abstract | Background: Despite 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. Methods: Before 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). Results: Thirty-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). Conclusions: SPIRIT-based templates could be used to improve the completeness of reporting of randomized trial protocols. | ca |
dc.format.extent | 8 | ca |
dc.language.iso | eng | ca |
dc.publisher | Springer Nature | ca |
dc.relation.ispartof | Research Integrity and Peer Review | ca |
dc.relation.ispartofseries | 9 | |
dc.rights | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | ca |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | |
dc.subject.other | Assaig controlat aleatoritzat | ca |
dc.subject.other | Directrius per a la presentació d'informes | ca |
dc.subject.other | Qualitat dels informes | ca |
dc.subject.other | Protocol d'assaig clínic | ca |
dc.subject.other | Ensayo controlado aleatorio | ca |
dc.subject.other | Directrices para la presentación de informes | ca |
dc.subject.other | Calidad de informes | ca |
dc.subject.other | Protocolo de ensayo clínico | ca |
dc.subject.other | Meta-research | ca |
dc.subject.other | Randomized controlled trial | ca |
dc.subject.other | Reporting guidelines | ca |
dc.subject.other | Reporting quality | ca |
dc.subject.other | Clinical trial protocol | ca |
dc.title | 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 | ca |
dc.type | info:eu-repo/semantics/article | ca |
dc.description.version | info:eu-repo/semantics/publishedVersion | ca |
dc.rights.accessLevel | info:eu-repo/semantics/openAccess | |
dc.embargo.terms | cap | ca |
dc.subject.udc | 61 | ca |
dc.identifier.doi | https://dx.doi.org/10.1186/s41073-024-00147-7 | ca |
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