Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY.
University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Crit Care Med. 2021 Oct 1;49(10):1684-1693. doi: 10.1097/CCM.0000000000005049.
Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.
A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.
Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.
The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.
These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.
评估镇静药物在接受机械通气的重症成人中的安全性和有效性的临床试验在方法学方法上存在很大差异。这种异质性妨碍了在研究之间比较结果的能力。镇静终点和治疗、教育和研究建议联合会召集了一次多学科专家会议，制定了 ICU 镇静试验的关键方法学要素建议，以帮助指导学术和行业临床研究人员。
2019 年 3 月 28 日至 29 日在华盛顿特区举行了为期两天的现场会议，随后进行了三轮在线修改 Delphi 共识过程。
来自学术界、工业界和食品和药物管理局的 36 名具有相关内容专业知识的参与者参加了现场会议，其中包括两名前 ICU 患者，大多数人完成了在线后续调查并参与了修改后的 Delphi 过程。
最终建议是根据调查结果、参与者对这些结果的反应、小组主持人撰写的摘要以及对会议记录的音频记录进行的审查反复完善的。制定了 15 项关于研究设计和实施、受试者入组、结局和测量工具的建议。达成共识的建议包括从 ICU 幸存者和/或他们的家属那里获得意见，确保使用 ICU 环境中镇静、疼痛和谵妄评估的经过验证的仪器对人员进行充分培训，以及需要方法学标准化。
这些建议旨在帮助研究人员设计、进行、选择终点，并报告涉及镇静药物和/或镇静方案的成年 ICU 患者机械通气的临床试验。这些建议应被视为改善临床试验和帮助减少未来临床试验中方法学异质性的起点。
