Diabetes Multi-Center Research Consortium (DMCRC) (Text Version)

Slide Presentation from the AHRQ 2009 Annual Conferenc

On September 14, 2009, Joe Selby made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (1.10 MB) (Plugin Software Help).

Slide 1

Diabetes Multi-Center Research Consortium (DMCRC)

• Coordinating Center
  • HMO Research Network DEcIDE Center
    • PI Joe Selby, MD
    • Co-PI Patrick O'Connor MD
• Affiliate Center
  • Johns Hopkins University DEcIDE Center
    • PI Jodi Segal, MD
    • Co-PI Eric Bass, MD

Slide 2

The Case for CER in Diabetes

• HIGH BURDEN OF DISEASE
  • High, rising prevalence of diabetes (>23 million diagnosed cases, 10% prevalence in adults)
  • Chronicity - life expectancy with diabetes >20 years; age at diagnosis decreasing; complication-related morbidities lead to many years with high annual costs

Slide 3

The Case for CER in Diabetes

• UNCERTAINTY? Variation in Practice
  • Multiple therapeutic choices (6 classes of oral agents, two classes of injectables)
  • Several options are relatively new and costly
  • Treatments vary in mechanisms of action, relative effectiveness and safety uncertain
  • Optimal treatment "strategies" unclear: timing of pharmacotherapy; treatment targets; sequencing and combination TX

Slide 4

The Case for CER in Diabetes

• Complexity in Optimizing Effectiveness
  • Self-care, including medication adherence is central to effectiveness, but difficult to optimize
  • Out-of-pocket medication costs interfere with medication adherence and self-care
  • Blood pressure, lipid control, and aspirin each more effective than "tight" glycemic control in preventing most diabetic complications
  • Weight management is important, but several medication classes cause weight gain

Slide 5

The Case for CER in Diabetes

• Complexity in Optimizing Effectiveness
  • "Systems Approaches" may enhance self-care and improve adherence and care coordination
  • Depression common in diabetes, but role of depression therapy in improving control unclear
  • Role of "tight" control in preventing CVD complications thrown into question in 2008 by three RCT's: ACCORD, ADVANCE, VADT
  • Other adverse consequences of tight control - wt. gain, hypoglycemia, fractures
  • Benefits may vary by patient age, DM duration

Slide 6

The Case for CER in Diabetes

• PREVENTION AND EARLY DETECTION
  • Reservoir of undiagnosed cases, but the net benefits of screening various populations for diabetes not entirely clear
  • Diabetes can be prevented or postponed by lifestyle and/or pharmacotherapy; but optimal "real world" programs not fully clarified

Slide 7

DMCRC Structure

Executive Committee - Includes AHRQ, Coordinating, Affiliate Center Leadership

• Data Committee
• Clinical Committee
• Methods Committee
• Stakeholder Committee

• Administrative Committee
• Project Manger

Slide 8

DMCRC Structure

Executive Committee - Includes AHRQ, Coordinating, Affiliate Center Leadership

• Data Committee
• Clinical Committee
• Methods Committee
• Stakeholder Committee

• Administrative Committee
• Project Manger

Slide 9

Expanded Executive Committee

• Also includes:
  • Vanderbilt DEcIDE Center - Marie Griffin MD, PI - Comparative Effectiveness of Oral Agents in Type 2 Diabetes
  • RTI DEcIDE Center - Suzanne West Ph.D. - Comparative Effectiveness of Oral Hypoglycemics on Chronic Kidney Disease and on Time to Initiation of Maintenance Insulin

Slide 10

DMCRC Work Assignments

• Comparative Effectiveness of Bariatric Surgery vs. Usual Care in Type 2 Diabetes (two projects)
• Proposal for New Statistical Briefs - using representative data to characterize trends in diabetes treatment and outcomes (joint)
• Form and Convene Stakeholders' Group (HMORN)
• Form and Convene Data Committee (JHU) - with HMORN, Vanderbilt, RTI participation
• Comparative Effectiveness Study of Intensive Glycemic Control vs. Less Intensive Control in presence vs. absence of tight blood pressure and lipid control (two projects)

Slide 11

DMCRC Stakeholder Committee

• Government Agencies - AHRQ, NIDDK, CMS, FDA, CDC, VA
• Clinicians - ACP,AAFP, AADE
• Patients - ADA, individual patient rep.
• Expanded DMCRC Executive Committee

Slide 12

Stakeholder - Developed Priorities

• Role of intensive glucose control in individuals with and without CVD, not typically enrolled in trials
• Comparative effectiveness of multi-risk factor reduction on long-term CV outcomes
• Comparison of system-based (coordinated) care vs. usual care
• Approaches to DX and treatment of depression in diabetes
• Risk factors for nonadherence - effects of nonadherence on costs and clinical outcomes

Slide 13

Stakeholder - Developed Priorities

• Effectiveness of eliminating co-pay for effective drugs (statins, ACE-I's, beta blockers, anti-diabetic meds) - on outcomes and total drug burden?
• Patient reported outcomes, HRQoL in relation to therapy
• Optimal timing for metformin initiation on the continuum of pre-DM -> DM
• Best strategies for behavior change. Who should do it and where should it be done?
• Understanding patient attitudes toward insulin use

Slide 14

Work Assignment #1:

Health outcomes of bariatric surgery in individuals with type 2 diabetes

• HMORN: PI: David Arterburn MD (Group Health Cooperative)
• Johns Hopkins U: PI: Jodi Segal MD

Slide 15

WA #1: Primary Aims

• Compare short-term outcomes between patients under-going BS and comparable patients who don't
  • Resolution of diabetes (no meds, nl FPG's
  • Medication use
  • BMI Change
  • Glycemic, BP, and lipid Control
• Compare longer-term outcomes between patients under- going BS and comparable patients who don't:
  • Recurrence of diabetes (abnormal labs or re-initiation of diabetes medications)
  • Death, hospitalization, re-operation
• Examine differences in these outcomes by type of BS: Bypass, banding, gastric sleeve

Slide 16

WA #1: Secondary Aims

• Compare a variety of shorter- and longer-term outcomes between patients under- going BS and comparable patients who don't (HMORN and JHU):
  • Development and progression of CKD and DN
  • Development and progression of diabetic retinopathy
  • Development of incident cardiovascular disease
  • Long-term health care utilization
  • Incidence of various cancers
  • Incidence of osteoporotic fracture
  • Incidence of urolithiasis
• Examine differences in these outcomes by type of BS: Bypass, banding, gastric sleeve

Slide 17

WA #1: Study Design:

Cohort Study in 180,000 patients with evidence of Type 2 diabetes, BMI >35, aged 18-30
Note: presence of BMI in EMR required
Approximately 3,100 BS with BMI 2002 - 08

Slide 18

WA #1: The Cohort

• 2002-2008
  • Enters cohort when T2 DM and BMI > 35 identified
• No BS
• 2002-2008
  • Bypass
• BS
• Banding
  • BS
• Sleeve
  • BS
• End 2009
• No BS

Slide 19

WA #1: Analysis Plan

• Propensity Score (time dependent) calculated for each cohort member
• Probabilities associated with each decile of PS examined, with possible trimming of very low probability deciles
• Modeling of outcomes in remaining cohort examined using time-varying predictors for BS and key covariates
• For comparisons by type of surgery, separate cohort analyses restricted to persons having BS
• Treatment heterogeneity examined by age group, presence of prior comorbid conditions

Slide 20

WA #1: Key Points in Analysis

• Multi-variable models predicting outcome will NOT use PS
• For discrete analyses, models will evaluate non-proportional (i.e., time-varying hazards)
• Will also examine effect heterogeneity by year of surgery and volume of surgeon
• Many more BS patients without pre-surgical BMI, who may contribute to some analyses where BMI less likely to confound.