Quality of Life in People with and at Quality of Life in People with and at Risk for Type 2 Diabetes:Risk for Type 2 Diabetes:

Findings from the Findings from the SStudy to tudy to HHelp elp IImprove mprove EEarly Evaluation and Management of Risk arly Evaluation and Management of Risk

Factors Factors LLeading to eading to DDiabetes (SHIELD)iabetes (SHIELD)

Richard H. Chapman, PhD1

Susan Grandy, PhD2

for the SHIELD Study Group1. 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

Background: DiabetesBackground: 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

Personal Impact of DiabetesPersonal 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

Diabetes & Quality of LifeDiabetes & 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

SHIELDSHIELD

• 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

ObjectivesObjectives

• 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

Methods: Identifying CohortsMethods: 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

Risk Factor DefinitionsRisk Factor Definitions

Risk Factor Definition

Abdominal obesity Men: waist circumference > 97cmWomen: 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 (heartdisease/myocardial infarction, narrow or blockedarteries, stroke, coronary artery bypass graftsurgery/angioplasty/stents/surgery to cleararteries)

Survey ProcessSurvey 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

HRQoL MeasuresHRQoL 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

HRQoL Measures: SF-12v2HRQoL 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)

HRQoL Measures: EQ-5DHRQoL 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

Statistical AnalysesStatistical 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)

ResultsResults

• 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.

Cohort Sent SF-12v2 EQ-5D VAS

0-2 RF 7,403 5,335 5,6383-5 RF 6,742 5,051 5,377T2D 5,000 3,530 3,851

Mean SF-12 PCS & MCS ScoresMean SF-12 PCS & MCS Scores

*P<0.001 vs. 0–2 RF**P<0.001 vs. 3–5 RF

0-2 RF 0-2 RF

3-5 RF

3-5 RF

T2D

T2D

0

10

20

30

40

50

60

Physical Component Mental Component

* ***

Mean EQ-5D VAS ScoresMean EQ-5D VAS Scores

0-2 RF

3-5 RFT2D

0

10

20

30

40

50

60

70

80

90

100

Current State of Health (VAS)

* ***

*P<0.001 vs. 0–2 RF**P<0.001 vs. 3–5 RF

SF-12 Scale ItemsSF-12 Scale Items

0

10

20

30

40

50

60

Physic

al Fun

ction

ing

Role Phy

sical

Bodily

Pain

Gener

al Healt

h

Vitality

Socia

l Fun

ction

ing

Role Em

otion

al

Men

tal H

ealth

0-2 RF 3-5 RF T2D

Multivariable Regression ResultsMultivariable Regression Results

Coeff. SE P-value Coeff. SE P-valueSF-12 PCS -4.82 0.25 <0.001 -6.52 0.27 <0.001SF-12 MCS -1.71 0.24 <0.001 -1.72 0.25 <0.001EQ-5D VAS -6.49 0.40 <0.001 -9.75 0.42 <0.001

3-5 RF T2DDependent Variable

0–2 risk factors as reference category

After adjusting for age, sex, race, household size, household income, geographic region, and BMI

ConclusionsConclusions

• 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.