Richard H. Chapman, PhD 1 Susan Grandy, PhD 2 for the SHIELD Study Group

1. Quality of Life in People with and at Risk for Type 2 Diabetes:Findings from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) Richard H. Chapman, PhD1 Susan Grandy, PhD2 for the SHIELD Study Group 1. ValueMedics Research, Falls Church, VA, USA 2. AstraZeneca Pharmaceuticals, Wilmington, DE, USA Research supported by AstraZeneca ISPOR 11th Annual International Meeting, Philadelphia May 23, 2006

2. Background: Diabetes • Diabetes affects ~21 million people in the US.1 • More than a million people develop the disease each year. • Diabetes was the sixth leading cause of death in the US in 2002. • Costs associated with diabetes were $132 billion in 2002, up from $98 billion in 1997.2 1. http://www.diabetes.org/about-diabetes.jsp 2. http://www.diabetes.org/for-media/2003-press-releases/03-24-03.jsp

3. Personal Impact of Diabetes • Chronic disease with ongoing monitoring, treatment • Complications from diabetes include: • Blindness • Kidney disease • Nerve damage • Circulatory problems • Heart disease • Stroke • Mortality rate 2–4 times higher than adults without diabetes* * http://www.diabetes.org/diabetes-statistics/complications.jsp

4. Diabetes & Quality of Life • Type 2 diabetes (T2D) substantially affects patients’ health-related quality of life (HRQoL) • Impacts of treatments, complications, and comorbidities have been documented to adversely affect HRQoL for patients with T2D • Limited information available on HRQoL of those without diabetes but at high risk for developing this condition

5. SHIELD • 5-year, national, longitudinal survey of diabetes, CVD, and metabolic disease risks in US adults • Purpose: To better understand patterns of health behavior, knowledge and attitudes of people living with T2D and those at high risk for its development • This analysis looks specifically at self-reported health-related quality of life (HRQoL) in individuals with T2D and those with varying degrees of risk for T2D

6. Objectives • To measure HRQoL of people with T2D and those with varying risk levels for T2D, using results from the SHIELD study’s baseline survey • To better understand the unmet medical need and burden of illness in the T2D and at-risk population

7. Methods: Identifying Cohorts • Screener questionnaire mailed to 200,000 nationally representative households • Part of the TNS* (formerly National Family Opinion) consumer panel • Responses for 211,097 adults from 127,420 households (64% response rate) • Used to identify individuals who self-reported: • T2D • Varying numbers of risk factors (RF) associated with T2D diagnosis *TNS = Taylor Nelson Sofres

8. Risk Factor Definitions Risk FactorDefinition Abdominal obesity Men: waist circumference > 97cm Women: waist circumference >89 cm BMI 28 kg/m2 Cholesterol problems Diagnosed with cholesterol problems of any type Hypertension Diagnosed with high blood pressure CV event One or more CV problems or events (heart disease/myocardial infarction, narrow or blocked arteries, stroke, coronary artery bypass graft surgery/angioplasty/stents/surgery to clear arteries)

9. Survey Process • Diabetes risk factors were summed (0–5) • Sampled respondents who self-reported T2D and 0, 1, 2, 3, 4, and 5 risk factors* • 64-item survey was sent to 22,001 people * Surveys were also sent to a sample of type 1 diabetes respondents, not reported here

10. HRQoL Measures • Respondents completed: • MOS Short Form-12 version 2 (SF-12 v2) • EuroQol – Five Dimension scale (EQ-5D) • For both scales: • Range = 0–100 • Higher scores indicate better quality of life

11. HRQoL Measures: SF-12v2 • 12-item measure of overall health status • Recall period = past 4 weeks • 8 domains: • Physical functioning • Role limitations due to physical health (role-physical) • Bodily pain • General health perceptions • Vitality • Social functioning • Role limitations due to emotional problems (role-emotional) • Mental health • Norm-based scoring (population mean = 50)

12. HRQoL Measures: EQ-5D • 5-item health profile • Can be used descriptively (as here) or converted to index utility value • Visual analogue scale (VAS) for current health • 0–100 graduated scale • 5 dimensions: • Mobility • Self-care • Usual activities • Pain/discomfort • Anxiety/depression

13. Statistical Analyses • Categorized into 0–2 risk factors, 3–5 risk factors, T2D • Mean scores, both overall and by domain • ANOVA with Fisher’s LSD post-hoc test (P<0.01) • Multivariable regression modeling with HRQoL measure as dependent variable, adjusting for: • Age, sex, race • Household size • Household income • Geographic region • BMI • Group (0–2 risk factors, 3–5 risk factors, T2D)

14. Results • Surveys were returned by 17,640 individuals (80% response rate) overall. • For the SF-12v2 and EQ-5D, complete responses were available from >70% of each cohort.

15. Mean SF-12 PCS & MCS Scores *P<0.001 vs. 0–2 RF **P<0.001 vs. 3–5 RF

16. Mean EQ-5D VAS Scores *P<0.001 vs. 0–2 RF **P<0.001 vs. 3–5 RF

17. SF-12 Scale Items

18. Multivariable Regression Results 0–2 risk factors as reference category After adjusting for age, sex, race, household size, household income, geographic region, and BMI

19. Conclusions • Ratings of HRQoL in people with T2D and those at increased risk for diabetes were similar. • Both of these groups reported substantially worse HRQoL than did those at lower levels of risk for diabetes. • HRQoL decrements were greater for physical domains than for emotional or mental. • Annual data from SHIELD will be used to evaluate HRQoL of those at increased risk as they transition to T2D.