一个失败的试验的尸检第二部分:结果,挑战,以及从DAISIES试验中吸取的教训
Başak İnce1, Matthew D Phillips1, Zohra Zenasni2
1Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
在DAISIES试验,比较住院和日间病人治疗精神性厌食症 (AN),由于不良招募失败了. 日间患者的治疗被认为更为积极,但无法得出有效性结论.
科学领域:
- 心理健康研究 心理健康研究
- 临床试验设计 临床试验设计
- 饮食障碍治疗方法 饮食障碍治疗方法
背景情况:
- 对于患有神经性厌食症 (AN) 的成年人,住院治疗与白天治疗的比较有效性尚不清楚.
- 该DAISIES试验旨在评估分步护理日期患者治疗 (DPT) 方法与常规住院治疗 (IP-TAU) 的非劣势性.
- 主要结局指标是12个月身体质量指数 (BMI) 的变化.
研究的目的:
- 为了确定逐步护理的DPT是否与成人AN的IP-TAU不逊色.
- 调查患者对不同治疗环境的经验和偏好.
- 确定终止试验的原因,并为未来的研究提供信息.
主要方法:
- 共有15名患有AN的患者参与了这项试验,随访时间为6个月或12个月.
- 由于招聘率较低,使用了总结统计数据,并通过专题分析分析了治疗经验的定性数据.
- 招聘挑战包括12个网站中只有6个网站的开放和患者治疗偏好影响参与.
主要成果:
- 参与者在基线上评价阶段性护理DPT比IP-TAU更可接受.
- 在12个月的随访期间,BMI在两个治疗组都增加.
- 定性调查结果显示,在两种情况下,护理的积极和消极方面都存在.
结论:
- 由于提前终止,该试验无法确定IP-TAU或分级护理DPT的有效性.
- 阶段性护理的DPT被参与者看得更好.
- 糟糕的招聘归因于患者,服务和系统因素,包括COVID-19大流行.
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