Sydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Qual Life Res. 2022 Oct;31(10):2901-2916. doi: 10.1007/s11136-022-03127-w. Epub 2022 May 12.
INTRODUCTION: Failure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018. METHOD: Annual workshops were conducted 2011-2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann-Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall. RESULTS: Participants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: 'specify PRO concepts/domains' (p = 0.05); 'methods for handling missing data' (p = 0.044). CONCLUSION: Although participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.
简介：未能在试验方案中纳入关键的患者报告结局（PRO）内容会影响所收集数据的质量和可解释性，导致研究浪费。我们的团队专门开发了基于证据的培训，专门针对方案中的 PRO 内容。我们旨在评估为期两天的教育研讨会是否能够提高方案的 PRO 完整性，以符合 2018 年 SPIRIT-PRO 扩展版中提出的基于共识的最低标准。
方法：年度研讨会于 2011-2017 年举行。参与者为癌症临床试验组的研究者/试验人员。尽管这些研讨会是在 2018 年之前开发的，但它们涵盖了 15/16 项 SPIRIT-PRO 内容。参与者在研讨会结束后立即和 2017 年 11 月进行了回顾性反馈，反馈内容进行了描述性总结。两名独立评估者根据 SPIRIT-PRO 对研讨会方案（由参与者在研讨会后制定）和对照组方案（同期非研讨会方案）进行评估。SPIRIT-PRO 项目的完整性评估（0=未解决，10=完全解决）。曼-惠特尼 U 检验评估了项目和总体上，研讨会方案是否比对照组得分更高。
结果：107 名参与者对研讨会给予了积极评价。在 2017 年，16/41 名调查回应者（39%）表示从未在实践中应用过；障碍包括角色限制（14/41，34%）和缺乏时间（5/41，12%）。研讨会方案的 SPIRIT-PRO 总体评分与对照组方案（n=9，中位数为 3.81/10，四分位距为 3.24）没有差异（p=0.35）。在“指定 PRO 概念/领域”（p=0.05）和“处理缺失数据的方法”（p=0.044）两个项目上，研讨会方案的评分高于对照组。
结论：尽管参与者对这些研讨会非常满意，但 PRO 方案内容的完整性通常没有提高。需要进一步进行知识转化工作，以帮助方案撰写者遵循 SPIRIT-PRO 指南，避免因 PRO 方案内容不理想而导致的研究浪费。
J Natl Cancer Inst. 2019-11-1
Patient Relat Outcome Meas. 2018-11-1
Zotero 插件