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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.
METHODS: 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.
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.
METHODS: 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.
摘要：
背景：尽管在标准方案项目：干预试验建议（SPIRIT）指南发布后，随机试验方案报告的完整性有所改善，许多项目报告仍然很差。本研究旨在评估使用SPIRIT定制的试验方案模板的有效性，以提高硕士学生作为硕士论文一部分编写的方案报告的完整性。
方法：在加泰罗尼亚国际大学骨科手动物理治疗大学硕士学位进行实验研究之前和之后（巴塞罗那，西班牙)。虽然干预后的学生被指示使用为SPIRIT量身定制的试验方案模板，干预前的学生未使用该模板.
方法：干预前和干预后期间充分报告项目的平均数之间的差异（0-10量表）。结果由两名盲法评估员独立和一式两份进行评估。学生和他们的导师不知道他们是研究项目的一部分。对于统计分析，我们使用广义线性回归模型(因变量：方案中充分报告的项目数；自变量：干预期，call,语言)。
结果：纳入了34项试验方案（17项，干预前；17项，干预后）。在干预后期间产生的方案(平均值:8.24;SD:1.52)比在干预前期间产生的方案(平均值:6.35;SD:1.80)更完整地报告;调整后差异:1.79(95%CI:0.58至3.00)。
结论：基于SPIRIT的模板可用于提高随机试验方案报告的完整性。
方法：在加泰罗尼亚国际大学骨科手动物理治疗大学硕士学位进行实验研究之前和之后（巴塞罗那，西班牙)。虽然干预后的学生被指示使用为SPIRIT量身定制的试验方案模板，干预前的学生未使用该模板.
方法：干预前和干预后期间充分报告项目的平均数之间的差异（0-10量表）。结果由两名盲法评估员独立和一式两份进行评估。学生和他们的导师不知道他们是研究项目的一部分。对于统计分析，我们使用广义线性回归模型(因变量：方案中充分报告的项目数；自变量：干预期，call,语言)。
结果：纳入了34项试验方案（17项，干预前；17项，干预后）。在干预后期间产生的方案(平均值:8.24;SD:1.52)比在干预前期间产生的方案(平均值:6.35;SD:1.80)更完整地报告;调整后差异:1.79(95%CI:0.58至3.00)。
结论：基于SPIRIT的模板可用于提高随机试验方案报告的完整性。
