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Updated: Jun 25, 2025

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
Enhancing reporting through structure: a before and after study on the effectiveness of SPIRIT-based templates to
David Blanco1, Márcio Vinícius Fagundes Donadio2,3, Aïda Cadellans-Arróniz2
1Department of Physiotherapy, Universitat Internacional de Catalunya, C/Josep Trueta S/N., Sant Cugat del Vallès, 08195, Barcelona, Spain. dblanco@uic.es.
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.
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