在骨科创伤随机对照试验中,不良事件的差异和患者报告的结果措施的差异之间没有相关性:系统性审查
Joshua A Parry1, Maryam Salimi1, Stephen C Stacey1
1Department of Orthopaedics, Denver Health Medical Center, University of Colorado School of Medicine, Denver, CO, United States.
Injury
|September 27, 2024
概括
患者的康复是骨科创伤护理的关键. 这项研究发现,随机对照试验中主要不良事件发生率与患者报告的结果之间没有联系,这表明未来的研究应该专注于不良事件.
科学领域:
- 整形外科手术 整形外科手术
- 创伤护理 创伤护理
- 临床试验 临床试验
背景情况:
- 没有不良事件的患者恢复是骨科创伤的优先事项.
- 随机对照试验 (RCT) 往往侧重于患者报告的结果测量 (PROM).
- 在RCT中主要不良事件率和PROM之间的关系尚未得到充分证实.
研究的目的:
- 系统地审查骨科创伤骨折管理中的RCT.
- 评估主要不良事件和PROM之间的差异之间的相关性.
- 确定不良事件的差异是否预测PROMs的差异.
主要方法:
- 系统地搜索相关RCT的在线数据库.
- 纳入标准:骨科创伤骨折管理研究报告主要不良事件和PROMs.
- 在不良事件和PROM中统计显著差异 (p < 0.05) 之间的评估相关性.
主要成果:
- 审查了30个涉及6769名患者的RCT.
- 在23.3%的研究中报告了主要不良事件的差异,而在6.7%的研究中报告了PROMs的差异.
- 显示不良事件差异的研究不太可能显示PROMs的差异 (p = 0.42).
结论:
- 在骨科创伤RCT中,不良事件发生率和PROM之间的差异之间没有发现相关性.
- 目前的RCT可能没有足够的动力来检测重大不良事件的差异.
- 未来的研究应该考虑加强研究,以检测重大不良事件的差异,这对患者和外科医生来说至关重要.
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