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智能手机视频观察与直接观察结核病治疗:多中心,分析师盲目的随机控制优势试验
Alistair Story1, Robert W Aldridge2, Catherine M Smith2
1Institute of Health Informatics, University College London, London, UK; Find and Treat, University College Hospitals NHS Foundation Trust, London, UK.
Lancet (London, England)
|February 26, 2019
概括
视频观察治疗 (VOT) 与直接观察治疗 (DOT) 相比,显著改善了结核病治疗观察率. 这种可访问,有效和廉价的方法为患者监督提供了更好的替代方案.
科学领域:
- 传染性疾病
- 公共卫生
- 临床试验
背景情况:
- 自20世纪90年代以来,直接观察治疗 (DOT) 已成为结核病治疗的标准,但对患者和提供者造成不便.
- 视频观察治疗 (VOT) 是世卫组织为结核治疗监督提供条件建议的替代方案.
- 这项研究评估了VOT在改善治疗观察水平方面与DOT相比的有效性.
研究的目的:
- 评估视频观察治疗 (VOT) 与直接观察治疗 (DOT) 相比改善了结核病治疗观察率.
- 确定VOT作为结核治疗监督方法的有效性和可接受性.
主要方法:
- 一个多中心,分析师盲目的,随机控制的优越性试验在22家英国诊所进行.
- 226名患有活跃结核的患者被随机分配到VOT (每日远程智能手机应用观察) 或DOT (每周3-5次亲自观察) 中.
- 主要结局是在前2个月完成了≥80%的计划治疗观察;进行了治疗意向 (ITT) 和受限分析.
主要成果:
- 在ITT分析中,70%的VOT患者获得了主要结果,而DOT患者的这一比例为31% (调整后OR为5. 48,p<0.0001).
- 限制性分析显示77%的VOT患者获得了主要结果,而DOT患者的这一比例为63% (调整后OR为2. 52,p=0. 017).
- 常见的不良反应包括胃痛,恶心和吐,14%的VOT患者和8%的DOT患者报告.
结论:
- 视频观察治疗 (VOT) 是比直接观察治疗 (DOT) 更有效的监督结核病治疗方法.
- VOT提供了一种更可接受,更有效,更便宜的DOT替代方案,用于监督每日和多次每日剂量.
- 对于许多不同环境的患者来说,VOT可能比DOT更好,提高了治疗的坚持和监督.
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