Daniel J Niven1, Gordon D Rubenfeld2, Andrew A Kramer3, Henry T Stelfox4. 1. Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada2Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada3Institute for Public Health, University of Calgary, Calgary, Alberta, Canada. 2. Trauma, Emergency, and Critical Care Program, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada5Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada. 3. Cerner Corporation, Vienna, Virginia. 4. Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada2Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada3Institute for Public Health, University of Calgary, Calgary, Alberta, Canada7Dep.
Abstract
IMPORTANCE: Little is known about the deadoption of ineffective or harmful clinical practices. A large clinical trial (the Normoglycemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation [NICE-SUGAR] trial) demonstrated that strict blood glucose control (tight glycemic control) in patients admitted to adult intensive care units (ICUs) should be deadopted; however, it is unknown whether deadoption occurred and how it compared with the initial adoption. OBJECTIVE: To evaluate glycemic control in critically ill patients before and after the publication of clinical trials that initially suggested that tight glycemic control reduced mortality (Leuven I) but subsequently demonstrated that it increased mortality (NICE-SUGAR). DESIGN, SETTING, AND PARTICIPANTS: Interrupted time-series analysis of 353,464 patients admitted to 113 adult ICUs from January 1, 2001, through December 31, 2012, in the United States using data from the Acute Physiology and Chronic Health Evaluation database. MAIN OUTCOMES AND MEASURES: The physiologically most extreme blood glucose level on day 1 of ICU admission defined glycemic control as tight control (glucose level, 80-110 mg/dL; to convert to millimoles per liter, multiply by 0.0555), hypoglycemia (glucose level, <70 mg/dL), and hyperglycemia (glucose level, ≥180 mg/dL). Temporal changes in each marker were examined using mixed-effects segmented linear regression. RESULTS: Before the publication of Leuven I, 17.2% (95% CI, 16.2%-18.2%) of ICU admissions had tight glycemic control, 3.0% (95% CI, 2.6%-3.5%) had hypoglycemia, and 40.2% (95% CI, 38.8%-41.5%) had hyperglycemia. After the publication of Leuven I, there were significant increases in the relative proportion of admissions with tight glycemic control (1.7% per quarter; 95% CI, 1.2%-2.3%; P<.001) and hypoglycemia (2.5% per quarter; 95% CI, 1.9%-3.2%; P<.001) and decreases in those with hyperglycemia (0.6% per quarter; 95% CI, 0.4%-0.9%; P<.001). Following the publication of NICE-SUGAR, there was no change in the proportion of patients with tight glycemic control or hyperglycemia. There was an immediate decrease in the relative proportion of patients with hypoglycemia (22.4%; 95% CI, 13.2%-30.1%; P<.001) but no subsequent change over time. CONCLUSIONS AND RELEVANCE: Among patients admitted to adult ICUs in the United States, there was a slow steady adoption of tight glycemic control following publication of a clinical trial that suggested benefit, with little to no deadoption following a subsequent trial that demonstrated harm. There is an urgent need to understand and promote the deadoption of ineffective clinical practices.
IMPORTANCE: Little is known about the deadoption of ineffective or harmful clinical practices. A large clinical trial (the Normoglycemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation [NICE-SUGAR] trial) demonstrated that strict blood glucose control (tight glycemic control) in patients admitted to adult intensive care units (ICUs) should be deadopted; however, it is unknown whether deadoption occurred and how it compared with the initial adoption. OBJECTIVE: To evaluate glycemic control in critically ill patients before and after the publication of clinical trials that initially suggested that tight glycemic control reduced mortality (Leuven I) but subsequently demonstrated that it increased mortality (NICE-SUGAR). DESIGN, SETTING, AND PARTICIPANTS: Interrupted time-series analysis of 353,464 patients admitted to 113 adult ICUs from January 1, 2001, through December 31, 2012, in the United States using data from the Acute Physiology and Chronic Health Evaluation database. MAIN OUTCOMES AND MEASURES: The physiologically most extreme blood glucose level on day 1 of ICU admission defined glycemic control as tight control (glucose level, 80-110 mg/dL; to convert to millimoles per liter, multiply by 0.0555), hypoglycemia (glucose level, <70 mg/dL), and hyperglycemia (glucose level, ≥180 mg/dL). Temporal changes in each marker were examined using mixed-effects segmented linear regression. RESULTS: Before the publication of Leuven I, 17.2% (95% CI, 16.2%-18.2%) of ICU admissions had tight glycemic control, 3.0% (95% CI, 2.6%-3.5%) had hypoglycemia, and 40.2% (95% CI, 38.8%-41.5%) had hyperglycemia. After the publication of Leuven I, there were significant increases in the relative proportion of admissions with tight glycemic control (1.7% per quarter; 95% CI, 1.2%-2.3%; P<.001) and hypoglycemia (2.5% per quarter; 95% CI, 1.9%-3.2%; P<.001) and decreases in those with hyperglycemia (0.6% per quarter; 95% CI, 0.4%-0.9%; P<.001). Following the publication of NICE-SUGAR, there was no change in the proportion of patients with tight glycemic control or hyperglycemia. There was an immediate decrease in the relative proportion of patients with hypoglycemia (22.4%; 95% CI, 13.2%-30.1%; P<.001) but no subsequent change over time. CONCLUSIONS AND RELEVANCE: Among patients admitted to adult ICUs in the United States, there was a slow steady adoption of tight glycemic control following publication of a clinical trial that suggested benefit, with little to no deadoption following a subsequent trial that demonstrated harm. There is an urgent need to understand and promote the deadoption of ineffective clinical practices.
Authors: Laura Barrie Smith; Nihar R Desai; Bryan Dowd; Alexander Everhart; Jeph Herrin; Lucas Higuera; Molly Moore Jeffery; Anupam B Jena; Joseph S Ross; Nilay D Shah; Pinar Karaca-Mandic Journal: Int J Health Econ Manag Date: 2020-04-30
Authors: George Hripcsak; Patrick B Ryan; Jon D Duke; Nigam H Shah; Rae Woong Park; Vojtech Huser; Marc A Suchard; Martijn J Schuemie; Frank J DeFalco; Adler Perotte; Juan M Banda; Christian G Reich; Lisa M Schilling; Michael E Matheny; Daniella Meeker; Nicole Pratt; David Madigan Journal: Proc Natl Acad Sci U S A Date: 2016-06-06 Impact factor: 11.205
Authors: Henry T Stelfox; Rebecca Brundin-Mather; Andrea Soo; Jeanna Parsons Leigh; Daniel J Niven; Kirsten M Fiest; Christopher James Doig; Danny J Zuege; Barry Kushner; Fiona Clement; Sharon E Straus; Deborah J Cook; Sean M Bagshaw; Khara M Sauro Journal: Intensive Care Med Date: 2019-02-01 Impact factor: 17.440