Reporting of Outcomes and Outcome Measures in Studies of Interventions to Prevent and/or Treat Delirium in the Critically Ill: A Systematic Review.

Rose, L; Agar, M; Burry, L; Campbell, N; Clarke, M; Lee, J; Marshall, J; Siddiqi, N; Page, V; Development of Core Outcome Sets for Effectiveness Trials of Interventions to Prevent and/or Treat Delirium (Del-COrS) Group

Reporting of Outcomes and Outcome Measures in Studies of Interventions to Prevent and/or Treat Delirium in the Critically Ill: A Systematic Review.

Rose, L Agar, M

Burry, L Campbell, N Clarke, M Lee, J Marshall, J Siddiqi, N Page, V Development of Core Outcome Sets for Effectiveness Trials of Interventions to Prevent and/or Treat Delirium (Del-COrS) Group

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Publisher:: LIPPINCOTT WILLIAMS & WILKINS
Publication Type:: Journal Article
Citation:: Critical care medicine, 2020, 48, (4), pp. e316-e324
Issue Date:: 2020-02-20

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Field	Value	Language
dc.contributor.author	Rose, L
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	Burry, L
dc.contributor.author	Campbell, N
dc.contributor.author	Clarke, M
dc.contributor.author	Lee, J
dc.contributor.author	Marshall, J
dc.contributor.author	Siddiqi, N
dc.contributor.author	Page, V
dc.contributor.author	Development of Core Outcome Sets for Effectiveness Trials of Interventions to Prevent and/or Treat Delirium (Del-COrS) Group
dc.date.accessioned	2020-09-15T05:41:38Z
dc.date.available	2020-09-15T05:41:38Z
dc.date.issued	2020-02-20
dc.identifier.citation	Critical care medicine, 2020, 48, (4), pp. e316-e324
dc.identifier.issn	0090-3493
dc.identifier.issn	1530-0293
dc.identifier.uri	http://hdl.handle.net/10453/142680
dc.description.abstract	OBJECTIVES:To inform development of a core outcome set, we evaluated the scope and variability of outcomes, definitions, measures, and measurement time-points in published clinical trials of pharmacologic or nonpharmacologic interventions, including quality improvement projects, to prevent and/or treat delirium in the critically ill. DATA SOURCES:We searched electronic databases, systematic review repositories, and trial registries (1980 to March 2019). STUDY SELECTION AND DATA EXTRACTION:We included randomized, quasi-randomized, and nonrandomized intervention studies of pharmacologic and nonpharmacologic interventions. We extracted data on study characteristics, verbatim descriptions of study outcomes, and measurement characteristics. We assessed quality of outcome reporting using the Management of Otitis Media with Effusion in Children with Cleft Palate study scoring system; risk of bias and study quality using the Cochrane tool and Scottish Intercollegiate Guidelines Network checklists. We categorized reported outcomes using Core Outcome Measures in Effectiveness Trials taxonomy. DATA SYNTHESIS:From 195 studies (1/195 pediatric) recruiting 74,632 participants and reporting a mean (SD) of 10 (6.2) outcome domains, we identified 12 delirium-specific outcome domains. Delirium incidence (147, 75% of studies), duration (67, 34%), and antipsychotic use (42, 22%) were most commonly reported. We identified a further 94 non-delirium-specific outcome domains within 19 Core Outcome Measures in Effectiveness Trials taxonomy categories. For both delirium-specific and nonspecific outcome domains, we found multiple outcomes in domains due to differing descriptions and time-points. The Confusion Assessment Method-ICU with Richmond Agitation-Sedation Scale to assess sedation was the most common measure used to ascertain delirium (51, 35%). Measurement generally began at randomization or ICU admission, and lasted from 1 to 30 days, ICU/hospital discharge. Frequency of measurement was highly variable with daily measurement and greater than daily measurement reported for 36% and 37% of studies, respectively. CONCLUSIONS:We identified substantial heterogeneity and multiplicity of outcome selection and measurement in published studies. These data will inform the consensus building stage of a core outcome set to inform delirium research in the critically ill.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	LIPPINCOTT WILLIAMS & WILKINS
dc.relation.ispartof	Critical care medicine
dc.relation.isbasedon	10.1097/ccm.0000000000004238
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences, 1110 Nursing, 1117 Public Health and Health Services
dc.subject.classification	Emergency & Critical Care Medicine
dc.title	Reporting of Outcomes and Outcome Measures in Studies of Interventions to Prevent and/or Treat Delirium in the Critically Ill: A Systematic Review.
dc.type	Journal Article
utslib.citation.volume	48
utslib.location.activity	United States
utslib.for	1103 Clinical Sciences
utslib.for	1110 Nursing
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney
utslib.copyright.status	closed_access	*
pubs.consider-herdc	false
dc.date.updated	2020-09-15T05:41:18Z
pubs.issue	4
pubs.publication-status	Published
pubs.volume	48
utslib.citation.issue	4

Abstract:

OBJECTIVES:To inform development of a core outcome set, we evaluated the scope and variability of outcomes, definitions, measures, and measurement time-points in published clinical trials of pharmacologic or nonpharmacologic interventions, including quality improvement projects, to prevent and/or treat delirium in the critically ill. DATA SOURCES:We searched electronic databases, systematic review repositories, and trial registries (1980 to March 2019). STUDY SELECTION AND DATA EXTRACTION:We included randomized, quasi-randomized, and nonrandomized intervention studies of pharmacologic and nonpharmacologic interventions. We extracted data on study characteristics, verbatim descriptions of study outcomes, and measurement characteristics. We assessed quality of outcome reporting using the Management of Otitis Media with Effusion in Children with Cleft Palate study scoring system; risk of bias and study quality using the Cochrane tool and Scottish Intercollegiate Guidelines Network checklists. We categorized reported outcomes using Core Outcome Measures in Effectiveness Trials taxonomy. DATA SYNTHESIS:From 195 studies (1/195 pediatric) recruiting 74,632 participants and reporting a mean (SD) of 10 (6.2) outcome domains, we identified 12 delirium-specific outcome domains. Delirium incidence (147, 75% of studies), duration (67, 34%), and antipsychotic use (42, 22%) were most commonly reported. We identified a further 94 non-delirium-specific outcome domains within 19 Core Outcome Measures in Effectiveness Trials taxonomy categories. For both delirium-specific and nonspecific outcome domains, we found multiple outcomes in domains due to differing descriptions and time-points. The Confusion Assessment Method-ICU with Richmond Agitation-Sedation Scale to assess sedation was the most common measure used to ascertain delirium (51, 35%). Measurement generally began at randomization or ICU admission, and lasted from 1 to 30 days, ICU/hospital discharge. Frequency of measurement was highly variable with daily measurement and greater than daily measurement reported for 36% and 37% of studies, respectively. CONCLUSIONS:We identified substantial heterogeneity and multiplicity of outcome selection and measurement in published studies. These data will inform the consensus building stage of a core outcome set to inform delirium research in the critically ill.

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http://hdl.handle.net/10453/142680