在阴道上垂脱落手术后,关于不良事件报告的患者观点
Vivian W Sung1, Shawn Menefee2, Holly E Richter3
1Division of Urogynecology, Department of Obstetrics & Gynecology, Warren Alpert Medical School of Brown University, Providence, RI.
American journal of obstetrics and gynecology
|May 6, 2024
概括
临床医生和患者对不良事件严重程度的分级往往不同,患者的观点显著影响决策后悔和生活质量等结果. 纳入患者的观点可以提高外科手术程序的评估.
科学领域:
- 泌尿和妇科 泌尿和妇科
- 患者报告的结果.
- 临床试验方法论 临床试验方法论
背景情况:
- 临床试验系统地监测不良事件 (AE),但往往不包括患者对严重性的看法.
- 标准AE分级依赖于临床医生对严重程度,预期性和与治疗相关性的评估.
研究的目的:
- 在泌尿外科手术中比较临床医生与患者对AE严重程度的分级.
- 评估患者分级AE严重程度与决策和生活质量的关联.
- 评估患者对AE严重程度的观点随着时间的推移而发生的变化.
主要方法:
- 补充研究 (不良事件报告中的患者视角 (PPAR)) 进行了关于阴道上垂垂手术的随机试验.
- 对19个特定的AE进行患者报告的AE严重程度的纵向收集,以及临床医生的分级.
- 分析评价者之间的一致性 (kappa统计) 和与经过验证的患者报告的结果指标的关联.
主要成果:
- 在临床医生和患者之间缺乏一致性 (kappa=0.24).AE严重程度分级.
- 观察到显著的不一致性,患者将中度/重度的副作用评为比临床医生轻度.
- 患者报告的严重副作用与决定后悔的增加,生活质量的降低和全球健康印象的恶化有关.
结论:
- 临床医生和患者对AE严重性的看法经常不一致.
- 患者对AE严重性的看法与关键的以患者为中心的结果有关.
- 整合患者的观点为评估外科干预提供了宝贵的见解.
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