Neurologic Critical Care

A Core Outcome Set for Research Evaluating Interventions to Prevent and/or Treat Delirium in Critically Ill Adults: An International Consensus Study (Del-COrS)

Rose, Louise PhD¹; Burry, Lisa PharmD^2,3; Agar, Meera PhD⁴; Campbell, Noll L. PharmD⁵; Clarke, Mike PhD⁶; Lee, Jacques MD⁷; Marshall, John C. MD⁸; Devlin, John W. PharmD⁹; Blackwood, Bronagh PhD, RN¹⁰; Needham, Dale M. MD, PhD¹¹; Siddiqi, Najma PhD¹²; Page, Valerie MB BCh¹³; for the Del-COrS Group

Author Information

¹ Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, London, United Kingdom.

² Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.

³ Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.

⁴ Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia.

⁵ College of Pharmacy, Purdue University, West Lafayette, IN.

⁶ School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, Northern Ireland

⁷ Inaugural Research Chair in Geriatric Emergency Medicine, Schwartz/Reisman Emergency Medicine Institute, Sinai Health System, Toronto, ON, Canada.

⁸ St Michael’s Hospital and Li Ka Shing Research Institute, Toronto, ON, Canada.

⁹ School of Pharmacy, Northeastern University, Boston, MA.

¹⁰ Wellcome-Wolfson Institute of Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland.

¹¹ School of Medicine, Johns Hopkins University, Baltimore, MD.

¹² Hull York Medical School, University of York, York, United Kingdom.

¹³ Watford General Hospital, Watford, United Kingdom.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

This Core Outcome Set is registered on the Core Outcome Measures in Effectiveness Trials website (http://www.comet-initiative.org/studies/details/796).

The systematic review is registered on International Prospective Register of Systematic Reviews (PROSPERO)-ID: CRD42016052704 (https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016052704).

Prof. Rose and Dr. Page conceived the ICU delirium core outcome set. Prof. Rose, and Drs. Burry, Agar, Campbell, Clarke, Lee, Marshall, Devlin, Needham, Siddiqi, and Page contributed to protocol development and the systematic review. Prof. Rose conducted the interviews. Prof. Rose, Dr. Needham, and Dr. Page recruited participants. Prof. Rose led the Delphi exercise. Prof. Rose and Dr. Page led the consensus meeting. Prof. Rose wrote the first article draft, and all authors including Drs. Blackwood, Devlin, and Needham from the Del-COrS group critically revised the article for important contents and approved the final version.

Supported, in part, by the Canadian Institutes of Health Research.

Dr. Rose’s institution received funding from Canadian Institutes of Health Research (CIHR). Dr. Agar disclosed that this study was supported by research funding by the CIHR, with funds held by the University of Toronto. Dr. Campbell received funding from Astellas Pharma, and he disclosed that he is a member of, and is on the Board of Directors for, the American Delirium Society. Dr. Clarke disclosed that he is a member of the Core Outcome Measures in Effectiveness Trials Management Group. Dr. Marshall received funding from AM Pharma (Data Safety Monitoring Board Chair). Dr. Needham’s institution received funding from the National Institutes of Health (NIH); he holds NIH/National Institute on Aging funding: grant number R24AG054259; he received funding from Haisco-USA Pharmaceuticals; and he received support for article research from the NIH. The remaining authors have disclosed that they do not have any potential conflicts of interest.

This work was conducted at Sunnybrook Health Sciences Centre, the University of Toronto, and King’s College London.

For information regarding this article, E-mail: [email protected]

Critical Care Medicine 49(9):p 1535-1546, September 2021. | DOI: 10.1097/CCM.0000000000005028

Abstract

OBJECTIVES:

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.

DESIGN:

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.

SUBJECTS:

International representatives from three stakeholder groups: 1) clinical researchers, 2) ICU interprofessional clinicians, and 3) ICU survivors and family members.

SETTING:

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.

INTERVENTION:

None.

MEASUREMENTS AND MAIN RESULTS:

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.

CONCLUSIONS:

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.