通过社区药房实施随机对照试验,以支持患有严重和持续精神疾病的人:COVID-19大流行期间的经验教训
Claire L O'Reilly1, Sara S McMillan2, Sarira El-Den1
1The University of Sydney, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Contemporary clinical trials
|May 31, 2023
概括
随着COVID-19的流行,临床试验中断,对心理健康研究产生了影响. 灵活的策略确保了社区药剂师领导的重度精神疾病患者试验的成功完成.
科学领域:
- 临床研究方法论临床研究方法论
- 公共卫生干预措施 公共卫生干预
- 心理健康服务研究 心理健康服务研究
背景情况:
- 随着COVID-19大流行,公共卫生部门出台了令令,加剧了心理健康症状,尤其是严重或持续性精神疾病 (SPMI) 患者.
- 疫情期间,临床研究面临重大挑战,影响了随机对照试验 (RCT) 的执行.
研究的目的:
- 描述COVID-19对PharMIbridge RCT实施的影响,这是一个社区药剂师为澳大利亚SPMI患者提供支持服务的社区药剂师.
- 概述用于成功实施PharMIbridge RCT在与流行病相关的中断中使用的策略.
主要方法:
- 该研究详细介绍了由于澳大利亚的公共卫生命令,包括边境关闭和居家禁令,而RCT协议的适应情况.
- 策略包括修改试验区域,在线转换培训材料,推迟面对面的组件,并鼓励远程医疗服务提供.
- 时间表的延长和灵活的方法被实施,同时保持关键的协议元素,如面对面的培训和现场考察.
主要成果:
- 尽管有中断,但PharMIbridgeRCT成功地适应了流行病状况.
- 一种灵活的,以解决方案为中心的方法,加上保持必要的面对面互动,导致了药店和消费者参与者的高保留率.
- 该研究表明,在全球卫生危机期间,对SPMI人群进行临床试验的可行性.
结论:
- 未来的临床试验规划必须纳入与流行病相关的风险,并需要监管机构的敏捷反应.
- 保持灵活性和调整研究方法对于在公共卫生紧急情况下成功完成RCT至关重要.
- 这些发现强调了社区药剂师主导干预和心理健康研究中的适应性试验管理的重要性.
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