Use of Real-World Data for Population Surveillance and Monitoring. Kasia Lipska, MD Yale School of Medicine November 17 th, 2018.

Transcription

1 Use of Real-World Data for Population Surveillance and Monitoring Kasia Lipska, MD Yale School of Medicine November 17 th, 2018 Grants: NIH Disclosures Consultant: Health Services Advisory Group (HSAG) Other: CMS (develop publicly reported quality measures)

2 Outline Diabetes complications surveillance Hypoglycemia surveillance Challenges Opportunities Glycemic Control in U.S. Adults HbA1c Ali MK et al. N Engl J Med 2013

3 Incidence of Diabetes Complications 1990 to 2010 Numerators: Acute myocardial infarction Stroke Leg amputation End stage renal disease Death from hyperglycemic crisis Denominators: Diagnosed diabetes All U.S. Adults National Hospital Discharge Survey U.S. Renal Data System National Vital Statistics System National Health Interview Survey U.S. Census Bureau Gregg EW et al. N Engl J Med 2014 Incidence of Diabetes Complications -68% -53% -51% -28% -64% Gregg EW et al. N Engl J Med 2014

4 Incidence of Diabetes Complications -32% NS NS +91% -42% Gregg EW et al. N Engl J Med 2014 Findings Large reductions in the incidence of major diabetes complications among people with diabetes Greatest for acute MI Smallest for ESRD Reductions greatest among population with diabetes

5 Questions Raised What accounts for the changes in incidence? Risk factor control (statin use, BP control, A1c, smoking) Revascularization options Healthcare delivery (integrated management of chronic disease, clinical decision-making support, patient education) Changes in the characteristics of the diabetes population (earlier detection) Questions Raised What about other complications? Retinopathy Neuropathy CKD Peripheral vascular disease Heart failure, cognitive impairment, depression, physical disability, diabetes-related cancers Hypoglycemia

6 Incidence of Hypoglycemia Hospitalizations 1999 to 2011 Numerator: Hypoglycemic coma Diabetic hypoglycemia NOS or hypoglycemic shock Specified and unspecified hypoglycemia Poisoning by insulin or antidiabetic agents Denominators: All Medicare FFS Beneficiaries Diagnosed Diabetes Medicare FFS Data Ginde algorithm Principal Discharge Dx Medicare FFS Data National Health Interview Survey Lipska KJ et al. JAMA Int Med 2014 From 1999 to 2011 Nearly 34 million beneficiaries with over 350 million patient-years of observation 429,850 hospitalizations for hypoglycemia Lipska KJ et al. JAMA Int Med 2014

7 Rate of Admissions per 100,000 Medicare Beneficiary-Years Hypoglycemia Admissions Denominator: All Medicare FFS Rate per 100,000 Patient-Years Hypoglycemia Year Lipska KJ et al. JAMA Int Med 2014 Hypoglycemia Admissions, by Age Denominator: All Medicare FFS Overall Year

8 Rate of Admissions per 100,000 Medicare Beneficiary-Years Hypoglycemia Admissions, by Race Denominator: All Medicare FFS Year Overall White Other Black Hypoglycemia Admissions Denominator: Diagnosed Diabetes Rate per 100,000 Patient-Years with Diabetes Year Lipska KJ et al. JAMA Int Med 2014

9 Findings Hypoglycemia admissions did not decline Significant disparities Black patients: 4-fold higher admissions Oldest adults: 2-fold higher admissions Lipska KJ et al. JAMA Int Med 2014 Questions Raised What accounts for these trends and disparities? What about hypoglycemic events that do not lead to hospitalization?

10 How Big is the Iceberg? Based on SMBG Hypoglycemic Events Based on CGM Symptomatic Nocturnal While Driving Disruptive at Work Requiring Help to Treat Requiring Paramedic Help Requiring ED Visit Requiring Hospitalization

11 Surveillance of Hypoglycemia Symptoms Misses asymptomatic episodes Not specific Healthcare utilization Misses majority of episodes treated outside of medical system At best, can capture: Ambulance ED visit Admission to the hospital Symptomatic hypoglycemia Surveillance of Hypoglycemia? Severe hypoglycemia (requiring assistance)? Emergency medical services (EMS)? Emergency department visit? Hospital admission

12 What Proportion of Severe Hypoglycemic Events is Captured via ED/Hospitalization Data? DISTANCE Survey Mean age N=13, years Female 49.4% Non-Hispanic white 25.7% Type 2 diabetes 97.7% Insulin-treated 26.4% Sulfonylurea-treated 63.2% Self-report of severe hypoglycemia ED visit or hospitalization for hypoglycemia 11.7% 0.8% Survey Findings Question: 5% of people who selfreported severe In hypoglycemia the past year, also how had many an times ED have visit or you hospitalization had a severe low blood sugar reaction such as passing out or needing help 20% of people with ED visit to treat the reaction? or hospitalization did not self-report an event Karter AJ et al., JAMA Int Med, 2018 Surveillance of Hypoglycemia Symptomatic hypoglycemia Severe hypoglycemia (requiring assistance) ~5% Emergency medical services (EMS) Emergency department visit Hospital admission

13 EMS Encounters for Hypoglycemia Percent NOT transported by EMS to the ED Moffet H et al., Prehosp Emerg Care Symptomatic hypoglycemia Surveillance of Hypoglycemia Severe hypoglycemia (requiring assistance) Emergency medical services (EMS) Variable 27-87% Emergency department visit Hospital admission

14 Emergency Hospitalizations for Adverse Drug Events Budnitz DS et al. N Engl J Med 2011 Symptomatic hypoglycemia Surveillance of Hypoglycemia Severe hypoglycemia (requiring assistance) Emergency medical services (EMS) Emergency department visit 40-50% Hospital admission

15 Severe Hypoglycemic Events ~5% treated in ED and/or admitted to the hospital ~1% treated and released by emergency medical services (EMS) ~94% not treated by medical professionals Challenges of Surveillance Reliance on healthcare utilization data Works best for conditions that always require hospitalization (such as acute MI) Less well for conditions that can be treated outside (such as hypoglycemia) May be affected by differences in coding or protocols of care (treat-and-release vs transport to ED)

16 Opportunities Patient Reported Outcomes Data Sources Data Sharing Willingness to Share Personal Information

17 Questions?