Dashboard Review Third Quarter of FY-2016 Joe Selby, MD, MPH Executive Director 1
On Target Projected/Target Q4 2015 Board of Governors Dashboard Off Target Q1 2016 Third Quarter FY-2016 (As of 6/30/2016) Needs Attention Q2 2016 Our Goals: Increase Information, Speed Implementation, and Influence Research Q3 2016 Expenditures – Total Budget, Up to $424M Funds Committed to Research, Up to $554M % of Research Projects on Track Q4 Q1 Q2 Q3 Research Awards 75 Budgeted Budget Percent Research Awards 50 Actual Estimated 2016 Budgeted All Other Q3 Actual Budget 25 Q2 Actual Q3 Actual Actual Q2 Actual All Other Q1 Actual Actual 0 % of Research Projects % Meeting All 0 100 200 300 400 500 600 0 50 100 150 200 250 300 350 in Green Zone Recruitment Milestones $ Millions $ Millions (Q2: N=335) (Q2: N=113) Final Progress Reports Submitted Journal Articles PCORnet Phase II Research Projects Underway in PCORnet 25 Expected Actual Q4 Q1 Q2 Q3 70 Target 60 20 Actual 50 0 5 10 15 20 15 40 Q1 Q2 Q3 2016 Target 30 10 Networks Engaged in Research Projects 20 10 5 Target 0 Actual 0 Journal Articles Journal Articles About or Q4-15 Q1-16 Q2-16 Q3-16 0 10 20 30 Published By Awardees By PCORI Methodology Standards Uptake Results: Increasing Information Results of Engagement in Research A network metaanalysis of treatments for Lupus Co-authors from 7 PCORI-funded studies focused 100 20 Nephritis provides data on efficacy and harms of on Kidney Disease shared 3 early examples treatments. The analysis demonstrated that for where engagement improved their research: 75 15 renal outcomes, immunosuppressive drugs 1) Stakeholders paved the way for a study were better than corticosteroids 50 implementation, 2) A patient advisory panel 10 ensured appropriateness of a decision aid in 25 5 development, and 3) Tribal Highlight: Health Affairs Special Issue NA community engagement Health Affairs Special Issue on Patients’ and 0 0 helped identify barriers to Consumers’ Use of Evidence featured 6 articles Methodology CME/CE Methodology Standards study implementation. Citations Certificates written by PCORI awardees or PCORI staff 2
Results of PCORI Research: Network Metaanalysis of Treatments for Lupus Nephritis Sing JA, Hossain A, et al. Treatments for Lupus Nephritis: A Systematic Review and Network Metaanalysis . Journal of Rheumatology . Sep 2016. • Awarded 2013, Assessment of Prevention, Diagnosis, and Treatment Options project • Principal Investigator: Jasvinder Singh, MBBS, MPH- University of Alabama at Birmingham This systematic review and Bayesian network metaanalyses Prednisone High dose (n=72) assessed the comparative effectiveness of immunosuppressive Cyclophosphamide High dose (n=138) drugs and corticosteroids for the treatment of Lupus Nephritis. 65 RCTs were included in the analysis. Mycophenolate mofetil (n=347) For renal outcomes, immunosuppressive drugs were better than corticosteroids, both clinically and statistically. There were differences in side effects including herpes zoster, Prednisone (n=129) alopecia, gastrointestinal tolerability, etc. This study provides data on relative and absolute differences of Cyclophosphamide + Azathioprine (N=45) treatment options, which will help with patient-physician discussions around medication use. This data is being Cyclophosphamide (n=251) incorporated into a patient-decision aid that is being tested in a Azathioprine (n=406) PCORI-funded RCT in patients with Lupus Nephritis. Evidence network for endstage renal disease 3
Results of Engagement in Research: PCORI Studies of Patients with Kidney Diseases Cukor D, Cohen LM, et al. Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases . Clin J Amer Soc Nephr . May 2016. Co-authored by researchers, patients, and stakeholders from 7 PCORI-funded studies focused on Kidney Disease, including a Patient-Powered Research Network focused on nephrotic syndrome, the article identified 3 early examples where engagement made a difference in the study: ” 1. Stakeholder advocacy motivated a major dialysis provider organization to find creative solutions to …The nephrology research community accommodate novel treatment delivery options in could serve as a model for implementing order to participate in the study (PI: Mehrotra) the ideals of community-based 2. Patient advisory panel feedback on the participatory research and patient- development of a decision aide helped ensure it centered methodologies. was appropriate for the target audience of predialysis CKD patients and their caregivers (PI: Tentori) PCORI Projects with contributing authors: • PI: Lewis Cohen 3. Community engagement with the Zuni people • PI: Elizabeth Cope helped identify psychologic and structural barriers • PI: Nashrollah Ghahramani that could be a challenge in a population with the • PI: Denise Hynes highest prevalence of dialysis-requiring kidney • PI: Rajnish Mehrotra • PI: Vallabh Shah diseases (PI: Shah) • PI: Francesca Tentori 4
Health Affairs Theme Issue Patients’ and Consumers’ Use of Evidence Six articles in the April 2016 Special Issue of Health Affairs: Patients’ and Consumers’ Use of Evidence , were authored by PCORI awardees or PCORI staff: 1. Dohan D, et al. The Importance Of Integrating Narrative Into Health Care Decision Making . Health Aff (Millwood) . Apr 2016. 2. Lavallee DC, et al . Incorporating Patient-Reported Outcomes Into Health Care To Engage Patients And Enhance Care . Health Aff (Millwood). Apr 2016. 3. Tai-Seale M, et al. Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior . Health Aff (Millwood) . Apr 2016. 4. Westfall JM, et al. Reinventing The Wheel Of Medical Evidence: How The Boot Camp Translation Process Is Making Gains . Health Aff (Millwood). Apr 2016. 5. Woolf SH, et al. Authentic Engagement Of Patients And Communities Can Transform Research, Practice, And Policy. Health Aff (Millwood) . Apr 2016. 6. Carman KL, et al. Understanding an Informed Public’s View on the Role of Evidence in Making Health Care Decisions. Health Aff (Millwood). Apr 2016. Altmetric Scores > 20 are typically in the “Top 5%” of Research Scored 5
We actively monitor our projects, support them to be successful, and classify their progress as shown below 6
The majority of our projects are on track and we are giving additional attention to those that are not Distribution of Project Status by Quarter Q3 2016 249 69 9 7 1 Q2 2016 239 65 13 9 Green Zone Yellow Zone Q1 2016 214 64 7 11 Orange Zone 1 Red Zone Award Terminated* Q4 2015 183 67 11 13 1 0 25 50 75 100 125 150 175 200 225 250 275 300 325 350 Number of Projects *Notice of Termination Issued 7
Projects that Fall Behind: Where are they now? Of the 29 Unique Projects in Q4-15 or Q1-16 that were Red/Orange: • 2/3 are now Green or Yellow in Q3-16 • 1/3 are still behind or were terminated Current Status Q3-16 Green Yellow 30% 37% Red Orange Terminated 13% 13% 7% 8
52% of Projects Started Recruitment Early or On Time For all projects that have or should have initiated recruitment (N=211) Timeliness of Recruitment Initiation Late- Pending Initiation Most Common Reasons for 5% Delayed Initiation • Subcontract negotiation On Time 28% • IRB Approval • Staff turnover Late 43% Early 24%
Most Projects Initiated Recruitment within a F ew M onths of Planned Start Date For all projects that have initiated recruitment (N=201) Timeliness of Recruitment Initiation 80 70 59 60 49 50 # Projects 40 35 30 24 20 12 10 10 6 2 2 1 1 0 5-6 3-4 1-2 0 1-2 3-4 5-6 7-8 9-10 11-12 13-14 On Months Early Months Late Time
62 Projects Have Completed Recruitment Timeliness of Recruitment Initiation Recruitment Completion On Time 28% Early or N=62 Late On Time Late 44% 24 11 Early or (37%) (18%) On Time Early Recruitment 28% Initiation Timeliness of Recruitment 12 15 Late Completion (19%) (26%) On Time Late 28% 42% Time 63% Stay in same timeliness category Of those that started late, 44% ended on time Early Of those that started early, 31% ended late 30%
Educational Outcomes Report for Methodology Standards CME/CE Activity After one year, Baylor College of Medicine provided an Educational Outcomes Report for the PCORI Methodology Standards CME/CE Activity (with 136 Survey Respondents) “Substantial knowledge and confidence gains are being achieved in line with, if not exceeding, the gains typically observed for Baylor’s educational initiatives. These strong results suggest that [participants] are anticipating improvements in conducting patient- centered research studies and are seeking to implement the Methodology Standards as applicable.” Examples: 12
Research-Ready PCORnet More than Half of DataMarts Are Now Approved for Research DataMart Totals: Data Characterization Progress 10 as of 6/30 (Q3) 90 49 as of 9/30 (Q4) 80 70 60 Approved for Research Number of DataMarts 50 40 Data Characterization Review 30 Prep-to-Research Ready Phase 20 Data Characterization Phase 10 Diagnostic Query Phase 0 March 31 May 5 June 30 August 15 Sept 30 Time (6 month period) 13
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