1 The Role of Stakeholders in the Diabetes Multi-Center Research Consortium (DMCRC) Joe V Selby MD, Director DMCRC Coordinating Center Kaiser Permanente Northern CA

2 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  AHRQ Project Officers  Barbara Bartman, MD MPH  Scott Smith, R.Ph., M.S.P.H., Ph.D.

3 DMCRC – 1 Expanded Executive Committee Also includes: 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. PI – Comparative Effectiveness of Oral Hypoglycemics on Chronic Kidney Disease and on Time to Initiation of Maintenance Insulin

4 Formation and Composition of DMCRC Stakeholders’ Committee Formation: June 2009 Formation: June 2009 Composition: Composition: – Expanded DMCRC Executive Committee – Government Agencies – AHRQ, NIDDK, CMS, FDA, CDC, VA – Clinicians – ACP,AAFP, AADE – Patients - ADA, individual patient rep.

5 Purpose of the DMCRC Stakeholders’ Committee To represent various constituencies and perspectives in a process of nominating and prioritizing topics for AHRQ-funded, empirical CER. To represent various constituencies and perspectives in a process of nominating and prioritizing topics for AHRQ-funded, empirical CER. To review AHRQ-funded diabetes-related CER and provide input on: To review AHRQ-funded diabetes-related CER and provide input on: – Interpretation – Dissemination – Future Questions

6 Timeline of DMCRC Stakeholders’ Meetings First Face-to-Face Meeting June 16, 2009 Initial Topic Nominations And Prioritization Focus on Treatment First Tele- Conference Feb 17, 2010 Focus on DM Prevention Second Face-to-face Meeting July 1, 2010 Review Ongoing CER Research Topic Re-prioritization for Both treatment and Prevention

7 Format of DMCRC Stakeholders’ Meetings Greetings and Update from AHRQ ~ 30 min Greetings and Update from AHRQ ~ 30 min Presentation/Discussion of Research ~ 3 hrs Presentation/Discussion of Research ~ 3 hrs – Findings from CER Work of Consortium members – Review of recent clinical trials findings/implications Nominations for Topics ~ 2 hrs Nominations for Topics ~ 2 hrs – All participants invited to offer nominations – Time for Brief Presentations Voting ~ 30 min Voting ~ 30 min – assessing preferences of Stakeholders vs. EC Brief Review of Results and Next Steps ~ 30 min Brief Review of Results and Next Steps ~ 30 min

8 Secrets of the Sauce DMCRC Stakeholders’ Committee √ Meticulous planning with facilitator √ Clear goals and game plan √ Leave plenty of time for discussion √ Facilitator to keep group on track, pull quiet ones out, chair topic nomination segment √ Acknowledge relevant work of stakeholders √ Demonstrate consequences of prior decisions and prioritization – i.e., funded projects

9 Stakeholder Prioritized List of CER Questions on Treatment Compare 2 nd line therapies for their long-term effects (e.g., CVD endpoints) – 19 votes Compare 2 nd line therapies for their long-term effects (e.g., CVD endpoints) – 19 votes Compare system approaches to coordinated care vs. usual care – 15 votes Compare system approaches to coordinated care vs. usual care – 15 votes Evaluate strategies to remove barriers to self care (including cost barriers) – 15 votes Evaluate strategies to remove barriers to self care (including cost barriers) – 15 votes Compare various providers and sites for providing behavior change support – 12 votes Compare various providers and sites for providing behavior change support – 12 votes Compare strategies for supporting insulin initiation – 9 votes Compare strategies for supporting insulin initiation – 9 votes Compare system-level strategies for supporting adherence to medications – 9 votes Compare system-level strategies for supporting adherence to medications – 9 votes

10 Stakeholder Prioritized List of CER Questions on Prevention Compare strengthened linkages between primary care and community resources vs. enhancing primary care to address overweight, lifestyle change – 25 votes Compare strengthened linkages between primary care and community resources vs. enhancing primary care to address overweight, lifestyle change – 25 votes What are effective strategies for counseling patients in the primary care setting for weight loss? (Including issues of coverage) – 21 votes What are effective strategies for counseling patients in the primary care setting for weight loss? (Including issues of coverage) – 21 votes Compare various approaches to GDM prevention and/or prevention of T2 DM in women with GDM. – 10 votes Compare various approaches to GDM prevention and/or prevention of T2 DM in women with GDM. – 10 votes

11 Keeping Stakeholders Engaged Emphasizing the funding by AHRQ of projects that address previously prioritized topics Emphasizing the funding by AHRQ of projects that address previously prioritized topics Presenting and discussing findings from studies they recommended be done Presenting and discussing findings from studies they recommended be done Incorporating their comments and responses into ongoing analyses or taking their suggestions and designing next generation protocols Incorporating their comments and responses into ongoing analyses or taking their suggestions and designing next generation protocols Identify effective, affordable (“Chevrolet”) programs to support individual behavior change – 10 votes Identify effective, affordable (“Chevrolet”) programs to support individual behavior change – 10 votes

12 Challenges Addressing or managing Stakeholder priority topics not squarely in COE purview Addressing or managing Stakeholder priority topics not squarely in COE purview – Prevention – Systems-level approaches – Engaging with community Staying on top and keeping Stakeholders on top of all the research that AHRQ is funding Staying on top and keeping Stakeholders on top of all the research that AHRQ is funding Adding stakeholders from delivery systems, possibly from industry Adding stakeholders from delivery systems, possibly from industry

13 Data Committee Clinical Committee Methods Committee Stakeholder Committee Project Manger Executive Committee – Includes AHRQ, Coordinating, Affiliate Center Leadership Next Steps

14 Next Steps Data Committee Clinical Committee Methods Committee Stakeholder Committee Project Manger Executive Committee – Includes AHRQ, Coordinating, Affiliate Center Leadership

15 Next Steps Data Committee Clinical Committee Methods Committee Stakeholder Committee Project Manger Executive Committee – Includes AHRQ, Coordinating, Affiliate Center Leadership