在2年期间,单个患者的随机临床试验
E B Larson1, A J Ellsworth, J Oas
1Department of Medicine, School of Medicine, University of Washington, Seattle.
JAMA
|December 8, 1993
概括
单个患者试验 (SPT) 是可行的和具有成本效益的,提供有价值的数据来指导慢性疾病的治疗决策. 这些正式的SPT提高了治疗精度和临床医生的信心.
科学领域:
- 临床研究方法论临床研究方法论
- 药物经济学 药物经济学
- 基于证据的医学是基于证据的医学.
背景情况:
- 单个患者试验 (SPT) 为治疗评估提供了个性化的方法.
- 评估正式的SPT服务的可行性和影响对于优化患者护理至关重要.
研究的目的:
- 评估实施单个患者试验 (SPT) 服务的可行性.
- 确定正式的SPT对治疗精度和临床决策的影响.
主要方法:
- 一个描述性和评价性研究SPTs进行了两年 (1988-1990).
- 试验是双盲,随机,多重交叉设计,随机分配和明确结果评估.
- 用视觉模拟尺度测量患者和医生的信心水平,试验前和试验后.
主要成果:
- 在34个完成的SPT中,有17个取得了最终结果. 在16项试验中,基于积极的结果,继续或启动治疗.
- 在18项试验中,由于无效,有害或等效性,治疗被中止或没有开始.
- 根据试验结果,医生的信心增加或减少,而大多数患者报告没有变化;该服务被评为非常有用.
结论:
- 单个患者试验 (SPT) 服务是可行的,成本与传统服务相美.
- SPT提高了临床医生的信心和治疗精度,特别是在慢性疾病的不确定的治疗价值方面.
- 正式的SPT可以有效地指导随后的治疗决策,当存在关于治疗有效性或安全性的不确定性时.
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