Louise Rose1,2, Meera Agar3, Lisa Burry4,5, Noll Campbell6, Mike Clarke7, Jacques Lee8, John Marshall9, Najma Siddiqi10, Valerie Page11. 1. Department of Critical Care Medicine, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. 2. Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, United Kingdom. 3. Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia. 4. Department of Pharmacy, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada. 5. Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada. 6. College of Pharmacy, Indiana University-Purdue University, Indianapolis, IN. 7. School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland. 8. Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. 9. St Michael's Hospital and Li Ka Shing Research Institute, Toronto, ON, Canada. 10. School of Medicine, York University, York, United Kingdom. 11. Intensive Care Unit, Watford General Hospital, Watford, United Kingdom.
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.
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.
Authors: Elizabeth Colantuoni; Mounica Koneru; Narjes Akhlaghi; Ximin Li; Mohamed D Hashem; Victor D Dinglas; Karin J Neufeld; Michael O Harhay; Dale M Needham Journal: Trials Date: 2021-05-20 Impact factor: 2.279
Authors: Louise Rose; Lisa Burry; Meera Agar; Bronagh Blackwood; Noll L Campbell; Mike Clarke; John W Devlin; Jacques Lee; John C Marshall; Dale M Needham; Najma Siddiqi; Valerie Page Journal: BMC Med Date: 2021-06-18 Impact factor: 8.775