A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study.

A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study.
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DOI:
10.1186/s12916-021-02015-3
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发表时间:
2021-06-18
期刊:
影响因子:
9.3
通讯作者:
Page V
Page V
中科院分区:
医学1区
文献类型:
--
作者:
Rose L;Burry L;Agar M;Blackwood B;Campbell NL;Clarke M;Devlin JW;Lee J;Marshall JC;Needham DM;Siddiqi N;Page V

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在急性医院环境中预防或治疗成人谵妄的干预试验报告了异质性结局。我们的目标是在关键利益相关者之间就未来的干预试验核心结局集(COS)达成国际共识,以预防和/或治疗急性护理住院且未入住重症监护室的成人谵妄。采用了严格的COS开发过程,包括系统综述、定性访谈、改良的德尔菲共识过程和使用名义组技术的面对面共识(注册http://www.comet- initiative.org/studies/details/796)。定性访谈的参与者是谵妄幸存者或家庭成员。共识方法的参与者包括来自三个利益相关者群体的国际代表:研究人员,临床医生,谵妄幸存者和家庭成员。项目生成从183项研究中确定了8项谵妄特异性结局和71项其他结局,从18项定性访谈中确定了30项结局,包括2项未从系统综述中提取的结局。涉及110名专家(包括研究人员(N = 32)、临床医生(N = 63)和谵妄幸存者和家庭成员(N = 15))的结局重复数据删除和正式共识过程导致COS包括6个结局:谵妄发生和复发、谵妄严重程度、谵妄持续时间、认知、情绪困扰和健康相关生活质量。研究局限性包括排除非英语研究和利益相关者,以及在面对面共识会议上谵妄幸存者/家庭的代表性很小。该COS得到了美国和澳大利亚谵妄协会以及欧洲谵妄协会的认可,建议用于未来的临床试验,以评估在急性护理医院就诊且未入住重症监护室的成人中的谵妄预防或治疗干预措施。在线版本包含补充材料,可通过10.1186/s12916-021-02015-3获取。
Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes. 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 adults with an acute care hospital admission and not admitted to an intensive care unit. A rigorous COS development process was used including a systematic review, qualitative interviews, modified Delphi consensus process, and in-person consensus using nominal group technique (registration http://www.comet- initiative.org/studies/details/796). Participants in qualitative interviews were delirium survivors or family members. Participants in consensus methods comprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivors and family members. Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30 outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. De-duplication of outcomes and formal consensus processes involving 110 experts including researchers (N = 32), clinicians (N = 63), and delirium survivors and family members (N = 15) resulted in a COS comprising 6 outcomes: delirium occurrence and reoccurrence, delirium severity, delirium duration, cognition, emotional distress, and health-related quality of life. Study limitations included exclusion of non-English studies and stakeholders and small representation of delirium survivors/family at the in-person consensus meeting. This COS, 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 adults presenting to an acute care hospital and not admitted to an intensive care unit. The online version contains supplementary material available at 10.1186/s12916-021-02015-3.
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