捕捉患者对变化的看法作为临床结果衡量标准
D Fischer1, A L Stewart, D A Bloch
1Palo Alto Medical Clinic, CA, USA.
患者对健康状况变化的连续和回顾性评估显示,一致性较差. 追溯测量更敏感,更好地与患者满意度保持一致,这表明它们在临床试验中的价值.
科学领域:
- 类风湿病学 类风湿病学
- 健康 结果 研究 研究 结果
- 临床试验方法论 临床试验方法论
背景情况:
- 测量患者健康状况的变化对于临床试验和实践至关重要.
- 临床试验经常使用连续患者测量,而实践则依赖于回顾性评估.
- 这两种测量方法之间的相关性尚未得到充分理解.
研究的目的:
- 为了比较连续患者的测量与回顾性患者评估疼痛和残疾的变化.
- 评估两种方法之间的一致性,敏感性和患者满意度的相关性.
主要方法:
- 一项对202名慢性关节炎患者进行的纵向调查,这些患者正在接受新疗法.
- 数据采集于基线,6周和4个月,使用序列 (视觉模拟疼痛量表,残疾健康评估问卷) 和回顾性 (7点利克尔特量表) 测量.
- 分析包括一致性 (McNemar,t测试),灵敏度和与患者满意度的相关性.
主要成果:
- 连续和回顾性测量结果显示,相关性很差,尤其是健康状况的小变化 (r=0.13-0.21).
- 与更大的变化相关性有所改善 (r=0.45-0.71),但整体一致性较低 (29%).
- 追溯评估对变化更敏感,与患者满意度更好地相关联.
结论:
- 测量健康状况变化的连续和追溯方法产生了不一致的结果.
- 回顾性患者评估可以提高临床试验数据的全面性.
- 纳入追溯评估可以改善临床试验结果与临床实践的协调.
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