前列腺研究中的患者报告结果措施:一个范围审查
Grace J Young1,2, Eleanor I Walsh2, J Athene Lane1,2
1Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
BJU international
|October 10, 2025
概括
前列腺研究中的患者报告结果指标 (PROM) 需要更好的报告. 在前列腺癌试验中遵守CONSORT关于PROMs的指导方针对于临床应用至关重要.
科学领域:
- 泌尿病学和瘤学研究研究
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 患者报告的结果指标 (PROM) 在评估治疗有效性方面越来越重要.
- 综合报告试验标准 (CONSORT) 准则旨在提高试验报告的质量.
- 了解前列腺研究中PROM的利用在CONSORT后实施是必不可少的.
研究的目的:
- 在2010年CONSORT指南引入后的十年里,总结PROM在前列腺研究中的使用情况.
- 评估PROM在关键医学期刊中的随机对照试验 (RCT) 报告质量.
主要方法:
- 在PubMed进行了系统的搜索,搜索2011年至2020年间在顶级瘤学,泌尿病学和医学期刊上发表的RCT.
- 提取的数据包括研究设计,干预措施,使用的特定PROM,时间,分析方法以及处理缺失数据或多重性.
- 包括121个符合条件的RCT,重点关注下尿路症状或前列腺癌.
主要成果:
- 国际前列腺症状评分和癌症/慢性疾病治疗功能评估问卷是最常见的.
- 关于PROM分析和数据处理的报告往往不足,60%的文章没有指定多重性或缺失数据的方法.
- 性不活跃的男性有时被排除在分析之外,这是一个值得注意的偶然发现.
结论:
- 为了更好的临床应用,需要在前列腺随机试验中完善PROM整合和分析.
- 建议鼓励遵守CONSORT报告PROM时间,缺失数据和多重性的指导方针.
- 开发前列腺癌RCT的核心结果和测量集将增强证据合成并减少冗余.
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