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Diabetes Multi-Center Research Consortium (DMCRC)

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. The Case for CER in Diabetes.

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Diabetes Multi-Center Research Consortium (DMCRC)

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  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

  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

  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

  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

  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

  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

  7. DMCRC Structure Executive Committee – Includes AHRQ, Coordinating, Affiliate Center Leadership Data Committee Methods Committee Administrative Committee Project Manger Clinical Committee Stakeholder Committee

  8. DMCRC Structure Executive Committee – Includes AHRQ, Coordinating, Affiliate Center Leadership Data Committee Methods Committee Administrative Committee Project Manger Clinical Committee Stakeholder Committee

  9. Expanded Executive Committee • Also includes: • VanderbiltDEcIDE Center – Marie Griffin MD, PI – Comparative Effectiveness of Oral Agents in Type 2 Diabetes • RTIDEcIDE Center – Suzanne West Ph.D. – Comparative Effectiveness of Oral Hypoglycemics on Chronic Kidney Disease and on Time to Initiation of Maintenance Insulin

  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)

  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

  12. Stakeholder - Developed Priorities

  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

  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

  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

  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

  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

  18. WA #1: The Cohort Enters cohort when T2 DM and BMI > 35 identified Bypass Banding BS No BS Sleeve No BS 2002-2008 2002-2008 End 2009

  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

  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.

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