BACKGROUND Trials of interventions to prevent or treat delirium in older adults resident in long-term care settings (LTC) report heterogenous outcomes, hampering the identification of effective management strategies for this important condition. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in this population. METHODS We used a rigorous COS development process including qualitative interviews with family members and staff with experience of delirium in LTC; a modified two-round Delphi survey; and virtual consensus meetings using nominal group technique. The study was registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (https://www.comet-initiative.org/studies/details/796). RESULTS Item generation identified 22 delirium-specific outcomes and 32 other outcomes from 18 qualitative interviews. When combined with outcomes identified in our earlier systematic review, and following an item reduction step, this gave 43 outcomes that advanced to the formal consensus processes. These involved 169 participants from 12 countries, and included healthcare professionals (121, 72%), researchers (24, 14%), and family members/people with experience of delirium (24, 14%). Six outcomes were identified as essential to include in all trials of interventions for delirium in LTC, and were therefore included in the COS. These are: 'delirium occurrence'; 'delirium related distress'; 'delirium severity'; 'cognition including memory', 'admission to hospital' and 'mortality'. CONCLUSIONS This COS, endorsed by the American Delirium Society and the European and Australasian Delirium Associations, is recommended for use in future clinical trials evaluating delirium prevention or treatment interventions for older adults residing in LTC.

中文翻译：

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评估预防或治疗长期护理老年居民谵妄的干预措施的研究的核心结果集：国际关键利益相关者知情共识研究。


背景 预防或治疗居住在长期护理机构 （LTC） 的老年人谵妄的干预措施试验报告了异质性结局，阻碍了为这一重要疾病确定有效的管理策略。我们的目标是在主要利益相关者之间建立国际共识，为未来预防和/或治疗该人群谵妄的干预措施试验建立核心结局集 （COS）。方法 我们使用了严格的 COS 开发过程，包括对家庭成员和有 LTC 谵妄经验的工作人员进行定性访谈;修改后的两轮 Delphi 调查;以及使用名义小组技术的虚拟共识会议。该研究已在有效性试验核心结局测量 （COMET） 倡议 （https://www.comet-initiative.org/studies/details/796） 注册。结果 项目生成从 18 次定性访谈中确定了 22 个谵妄特异性结局和 32 个其他结局。当我们与我们早期系统评价中确定的结局相结合，并遵循项目减少步骤时，这得到了 43 个进入正式共识过程的结果。这些研究涉及来自 12 个国家的 169 名参与者，包括医疗保健专业人员 （121， 72%）、研究人员 （24， 14%） 和家庭成员/有谵妄经历的人 （24， 14%）。6 个结局被确定为必须纳入所有 LTC 谵妄干预试验，因此被纳入 COS。这些是：“谵妄发生”;“谵妄相关痛苦”;“谵妄严重程度”;“认知包括记忆”、“入院”和“死亡率”。 结论该 COS 得到美国谵妄协会以及欧洲和澳大利亚谵妄协会的认可，推荐用于未来的临床试验，评估居住在 LTC 的老年人的谵妄预防或治疗干预措施。