GRADE for reducing adverse GRADE for reducing adverse outcomes outcomes • actions to reduce adverse outcomes actions to reduce adverse outcomes should be based on confidence in should be based on confidence in estimates of effect estimates of effect • GRADE provides detailed guidance for GRADE provides detailed guidance for assessing confidence assessing confidence • avoids premature quality control avoids premature quality control initiatives initiatives
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GRADE for reducing adverse outcomes actions to reduce adverse outcomes should be based on confidence in estimates of effectactions to reduce adverse outcomes.
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GRADE for reducing adverse GRADE for reducing adverse outcomesoutcomes
• actions to reduce adverse outcomes actions to reduce adverse outcomes should be based on confidence in should be based on confidence in estimates of effectestimates of effect
• GRADE provides detailed guidance for GRADE provides detailed guidance for assessing confidenceassessing confidence
• avoids premature quality control initiativesavoids premature quality control initiatives
UCLA Clinicians Use IT to Facilitate Innovations in Hyperglycemia Care
Hyperglycemia in the ICUHyperglycemia in the ICU
A landmark clinical trial performed in 2001 A landmark clinical trial performed in 2001 changed clinicians' views about stress changed clinicians' views about stress hyperglycemia in the inpatient setting. The hyperglycemia in the inpatient setting. The authors of that authors of that New England Journal of MedicineNew England Journal of Medicine study, concluded that "Intensive insulin therapy study, concluded that "Intensive insulin therapy to maintain blood glucose at or below 110 mg to maintain blood glucose at or below 110 mg per deciliter reduces morbidity and mortality per deciliter reduces morbidity and mortality among critically ill patients in the surgical among critically ill patients in the surgical intensive care unit" (Van Den Berghe, et al., intensive care unit" (Van Den Berghe, et al., 2001). 2001).
Van den Berghe, NEJM, 2001Van den Berghe, NEJM, 2001
• 1548 patients surgical ICU, ventilated1548 patients surgical ICU, ventilated– intensive insulin therapy vs conventionalintensive insulin therapy vs conventional
• planned to enroll 2,500planned to enroll 2,500
• interim analysis at three month intervalsinterim analysis at three month intervals
• p < 0.01 (“designed to allow early stopping”)p < 0.01 (“designed to allow early stopping”)
• stopped after 4stopped after 4thth interim analysis interim analysis– 98 deaths98 deaths
Van den Berghe, NEJM, 2001Van den Berghe, NEJM, 2001
• ICU mortalityICU mortality– 35 of 744 (4.6%) in intensive insulin– 63 of 765 (8.0%) in conventional
• RR 0.58 (95% CI 0.38 to 0.78)
ImprecisionImprecision
• optimal information sizeoptimal information size– # of pts from conventional sample size calculation# of pts from conventional sample size calculation– specify control group risk, specify control group risk, αα, , ββ, , ΔΔ