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临床研究中基于患者报告结局的缺失值问题及对策

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目的 整合患者报告结局(patient-reported outcomes,PRO)的缺失值问题及对策,为尽可能降低 PRO数据缺失所带来的影响提供解决思路和参考.方法 检索国内外相关文献,从数据缺失的原因及其影响、可行的预防措施、对缺失值的处理及规范报道等几个方面归纳PRO的缺失值问题.结果 对缺失数据产生原因及其严重影响的充分认识,严谨的研究设计,规范的实施流程等可降低PRO数据缺失的风险;对无法避免的缺失数据进行合理处理和分析,并透明报告,也能得出可信的结论.结论 随着科学研究的不断发展,PRO数据应被更合理、更有效地利用.
Missing data in patient-reported outcomes in clinical studies and its solutions
Objective To explore missing data in patient-reported outcomes(PRO)and the solutions,and to provide references for reducing the impact of missing data in PRO as much as possible.Methods Relevant literatures at home and abroad were searched,and missing data in PRO were summarized from the perspective of causes and influences of data missing,feasible preventive measures,handling of missing data,and standardized reporting.Results Adequate understanding of the causes and serious impacts of missing data,rigorous study design,and standardized implementation procedures can reduce the risk of data missing in PRO.Reasonable processing and analysis of unavoidable missing data and transparent reporting were beneficial to drawing credible conclusions.Conclusion With the continuous development of scientific research,PRO data should be used more rationally and effectively.

patient-reported outcomesmissing datascaleclinical study

史晨、闫泽霖、马嘉骏、李新旭、欧春泉

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南方医科大学 公共卫生学院生物统计学系,广东 广州 510515

博济医药科技股份有限公司 博济数据科技(北京)有限公司,北京 100077

患者报告结局 缺失值 量表 临床研究

2024

护理学报
南方医科大学

护理学报

CSTPCD
影响因子:1.705
ISSN:1008-9969
年,卷(期):2024.31(18)