Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, United Kingdom.
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
Crit Care Med. 2021 Sep 1;49(9):1535-1546. doi: 10.1097/CCM.0000000000005028.
Delirium in critically ill adults is highly prevalent and has multiple negative consequences. To-date, trials of interventions to prevent or treat delirium report heterogenous outcomes. To develop international consensus among key stakeholders for a core outcome set for future trials of interventions to prevent and/or treat delirium in critically ill adults.
Core outcome set development, as recommended by the Core Outcome Measures in Effectiveness Trials Handbook. Methods of generating items for the core outcome set included a systematic review and qualitative interviews with ICU survivors and family members. Consensus methods include a two-round web-based Delphi process and a face-to-face meeting using nominal group technique methods.
International representatives from three stakeholder groups: 1) clinical researchers, 2) ICU interprofessional clinicians, and 3) ICU survivors and family members.
Telephone interviews, web-based surveys, and a face-to-face consensus meeting held at the 2019 European Delirium Association's annual meeting in Edinburgh, Scotland.
None.
Qualitative interviews with 24 ICU survivors and family members identified 36 potential outcomes; six were additional to the 97 identified from the systematic review. After item reduction, 32 outcomes were presented in Delphi Round 1; 179 experts participated, 38 ICU survivors/family members (21%), 100 clinicians (56%), 41 researchers (23%). Three additional outcomes were added to Round 2; 134 Round 1 participants (75%) completed it. Upon conclusion of the consensus building processes, the final core outcome set comprised seven outcomes: delirium occurrence (including prevalence or incidence); delirium severity; time to delirium resolution; health-related quality of life; emotional distress (i.e., anxiety, depression, acute and posttraumatic stress); cognition (including memory); and mortality.
This core outcome set, endorsed by the American and Australian Delirium Societies and European Delirium Association, is recommended for future clinical trials evaluating delirium prevention or treatment interventions in critically ill adults.
危重病成人谵妄的发病率很高，且有多种不良后果。迄今为止，预防或治疗谵妄的干预措施试验报告的结果存在差异。旨在为未来预防和/或治疗危重病成人谵妄的干预措施试验制定国际共识核心结局集。
按照有效性试验核心结局测量手册推荐的核心结局集制定方法。生成核心结局集项目的方法包括对 ICU 幸存者和家属进行系统评价和定性访谈。共识方法包括两轮基于网络的德尔菲法和使用名义群体技术方法的面对面会议。
来自三个利益相关者群体的国际代表：1）临床研究人员，2）ICU 跨专业临床医生，和 3）ICU 幸存者和家属。
苏格兰爱丁堡 2019 年欧洲谵妄协会年会上进行的电话访谈、网络调查和面对面共识会议。
无。
对 24 名 ICU 幸存者和家属进行的定性访谈确定了 36 个潜在结局；其中 6 个是系统评价中确定的 97 个结局之外的。经过项目删减，32 个结局在德尔菲法第一轮中提出；179 名专家参与，其中 38 名 ICU 幸存者/家属（21%）、100 名临床医生（56%）、41 名研究人员（23%）。第二轮增加了另外 3 个结局；134 名第一轮参与者（75%）完成了第二轮。在达成共识的过程结束时，最终的核心结局集包括七个结局：谵妄发生（包括患病率或发病率）；谵妄严重程度；谵妄缓解时间；健康相关生活质量；情绪困扰（即焦虑、抑郁、急性和创伤后应激）；认知（包括记忆）；和死亡率。
这个核心结局集得到了美国和澳大利亚谵妄学会以及欧洲谵妄协会的认可，建议用于未来评估危重病成人谵妄预防或治疗干预措施的临床试验。
