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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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.

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通过结构加强报告:基于 SPIRIT 的模板提高随机对照试验方案报告完整性的前后效果研究。
背景:尽管随机试验方案报告的完整性在《标准方案项目:干预试验建议》(SPIRIT)指南后,尽管随机试验方案报告的完整性有所提高,但仍有许多项目报告不全。本研究旨在评估使用 SPIRIT 定制的试验方案模板对提高硕士生硕士论文中试验方案报告完整性的效果:方法:在加泰罗尼亚国际大学(西班牙巴塞罗那)骨科徒手物理治疗专业的大学硕士学位课程中进行实验前后对比研究。干预后的学生在指导下使用为 SPIRIT 量身定制的试验方案模板,而干预前的学生则不使用该模板:充分报告项目(0-10 分制)的平均数量在干预前和干预后的差异。结果由两名盲人评估员独立评估,一式两份。学生及其导师并不知道他们是研究项目的一部分。在统计分析中,我们使用了广义线性回归模型(因变量:方案中充分报告的项目数;自变量:干预期、电话、语言):结果:共纳入 34 份试验方案(17 份为干预前方案;17 份为干预后方案)。干预后制定的方案(平均值:8.24;标准差:1.52)比干预前制定的方案(平均值:6.35;标准差:1.80)报告得更完整;调整后的差异为 1.79(95% CI):1.79 (95% CI: 0.58 to 3.00):基于 SPIRIT 的模板可用于提高随机试验方案报告的完整性。
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