Board of Governors Meeting via Teleconference/Webinar September 12, 2017 12:00 - 2:00 pm ET
Welcome and Introductions Grayson Norquist, MD, MSPH Chairperson, Board of Governors Joe Selby, MD, MPH Executive Director 2
Dr. Robert “Bob” Louis Jesse, M.D., Ph.D It is with great sadness that PCORI learned of the recent death of Dr. Robert Jesse, a distinguished physician, long- time member of the health leadership team at the Department of Veteran Affairs, and an original member of PCORI’s Board of Governors. Bob died of cancer, at home, surrounded by family. Bob was a great friend of patients, clinicians, and all of us at PCORI who were fortunate to spend time with him. He was an intelligent and warm leader, a caring and tireless mentor, and dedicated in all of his work to improving the lives of patients and their families. We will all miss Bob’s wise guidance as a member of our Board of Governors; PCORI will miss him as a close friend and colleague. But we’re all grateful that his substantial legacy includes having been one of those who played an essential role in making PCORI what it is today. 3
Agenda Time Agenda Item 12:00 Call to Order, Roll Call, and Welcome Consider for Approval: 12:00-12:05 Minutes of the August 15, 2017 Board Meeting Consider for Approval: 12:05 – 12:25 Cycle 3 2016 Pragmatic Clinical Studies (PCS) Awards Consider for Approval: 12:25-12:45 Cycle 3 2016 Targeted PFA Awards – Sickle Cell Disease Consider for Approval: 12:45-1:05 Cycle 3 2016 Targeted PFA Awards – Multiple Sclerosis 1:05-1:25 Consider for Approval: Cycle 3 2016 Targeted PFA Award – Opioid Use for Chronic Pain Consider for Approval: 1:25-1:35 Bylaws and Methodology Committee (MC) Charter Consider for Approval: 1:35-1:40 MC Chair and Vice-Chair Nominations 4
Board Vote • Approve the Minutes of the August 15, 2017 Call for a Motion to: Board Meeting • Second the Motion Call for the Motion • If further discussion, may propose an Amendment to the Motion or an Alternative to Be Seconded: Motion • Vote to Approve the Final Motion Voice Vote: • Ask for votes in favor, opposed, and abstentions 5
Pragmatic Clinical Studies Cycle 3 2016 Award Slate Christine Goertz, DC, PhD Chair, Selection Committee Evelyn P. Whitlock, MD, MPH Chief Science Officer 6
Pragmatic Clinical Studies – Cycle 3 2016 Merit Review Criteria 1. Potential for the study to fill critical gaps in evidence 2. Potential for the study findings to be adopted into clinical practice and improve delivery of care 3. Scientific merit (research design, analysis, and outcomes) 4. Investigator(s) and environment 5. Patient-centeredness 6. Patient and stakeholder engagement 7
Pragmatic Clinical Studies – Cycle 3 2016 Process Overview • 66 Letters of Intent (LOIs) submitted • 31 LOIs invited to submit a full application ( 47% ) • 28 applications were received ( 90% of invited LOIs ) Funding rate is 11 percent • We are proposing to fund 3 applications* out of 28 received applications 70 66 60 50 LOIs Received 40 LOIs Accepted Applications Received 30 31 Proposed for Funding 28 20 10 3 0 Pragmatic Clinical Studies 8 *Recommended by the Selection Committee
Pragmatic Clinical Studies – Cycle 3 2016 3 Recommended Projects Project PRO-ACTIVE: Comparing the Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer PREPARE: Pragmatic Randomized Trial Evaluating Pre-Operative Antiseptic Skin Solutions in Fractured Extremities Comparative Effectiveness of School-Based Caries Prevention Programs for Children in Underserved, Low Income, Hispanic Communities 9
Project 1: PRO-ACTIVE: Comparing the Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer • Research Question: What is the comparative effectiveness of proactive vs reactive swallowing interventions among patients with head and neck cancer (HNC) planning to undergo radiotherapy (RT)? • Population: Any patient who begins radiotherapy for HNC with a functional swallow at baseline • Intervention/Comparator(s): • Pro-Active (high-intensity): swallowing exercises in addition to therapy focused on eating challenging foods, given during the period of RT • Pro-Active (low-intensity): therapy focused on eating challenging foods, started prior to RT • Re-Active: therapy following the onset of dysphagia • Outcomes of Interest: • Primary: Duration of feeding tube use post RT • Secondary: quality of life, functional status and physical dysphagia • Study Design: Randomized controlled trial (RCT) • Sample Size: 952 patients at 7 sites • Length of Follow-up: 12 months • Duration of Active Intervention: Approximately 2 months • Total Project Cost: $8.5M 10
Project 1: PRO-ACTIVE: Comparing the Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer • Potential Impact: Provides better evidence about how to plan rehabilitation services for preventing dysphagia • Patient-Centeredness: Maintaining the ability to swallow foods and liquids is ranked most important by patients with HNC • Engagement: Stakeholders include patients, physicians, allied health providers. Policymakers and payers will convene regularly via quarterly Stakeholder Research Partner Panels 11
Project 2: PREPARE: Pragmatic Randomized Trial Evaluating Pre-Operative Antiseptic Skin Solutions in Fractured Extremities • Research Question: What is the comparative effectiveness of two pre-operative antiseptic skin solutions for acute extremity fracture surgery? • Population: Patients aged 16+ receiving surgical treatment of an extremity fracture • Intervention: Iodine povacrylex in alcohol • Comparator(s): Chlorhexidine gluconate in alcohol • Outcomes of Interest: • Primary: Surgical site infection (SSI) • Secondary: Quality of life (SF-12) • Study Design: Cluster crossover randomized trial • Sample Size: 7820 across 10 sites • Length of Follow-up: 90 days • Duration of Active Intervention: Pre-operative application of antiseptic solution • Total Project Cost: $10.9 M 12
Project 2: PREPARE: Pragmatic Randomized Trial Evaluating Pre-Operative Antiseptic Skin Solutions in Fractured Extremities • Potential Impact: In compound fractures, the incidence of Surgical Site Infection is high. No previous trials have included patients undergoing fracture surgery • New evidence for patients with compound fractures may have a major influence on clinical practice • Including patients with closed fractures can provide insight into whether the choice of skin preparation solution is relevant for other types of orthopedic surgery • Patient-Centeredness: Data collection incorporates minimal burden to participants (occurs during routine post-operative follow up visits) • Engagement: The study will leverage the infrastructure of an existing patient engagement program at the host university. The study will engage patient leaders as co-presenters in webinars and live sessions and as co-authors on abstracts and publications 13
Project 3: Comparative Effectiveness of School-Based Caries Prevention Programs for Children in Underserved, Low Income, Hispanic Communities • Research Question: What is the comparative effectiveness of simple treatment compared to complex treatment in two school-based, caries prevention programs? • Population: Low income Hispanic/Latino elementary school children in a medically underserved area • Intervention: Simple treatment (silver diamine fluoride plus fluoride varnish) • Comparator(s): Complex treatment (traditional sealants and fluoride varnish) • Outcomes of Interest: • Primary: Prevention of progression of existing caries and new caries prevention • Secondary: Quality of life, toothaches, school absences, academic performance • Study Design: Cluster randomized controlled trial • Sample Size: 14,100 (60 schools) • Length of Follow-up: 2 years for prevention of progression of existing caries; 3 years for new caries prevention • Duration of Active Intervention: One school-based dental visit • Total Project Cost: $13.4M 14
Project 3: Comparative Effectiveness of School-Based Caries Prevention Programs for Children in Underserved, Low Income, Hispanic Communities • Potential Impact: The study could lead to higher healthcare quality for patients and sustainable access to dental care for a large underserved minority patient population. If both methods are equally effective, simple prevention could reach four times as many children for the same time and cost as the complex approach • Patient-Centeredness: The study team has involved Latino/Hispanic low-income parents of school age children in the program design since 2013. The proposal incorporates multiple patient-centered requests including: free school-based care, potential color change (silver diamine fluoride on posterior teeth only), improved health, better academic performance, and quality of life • Engagement: Includes patient and stakeholder partners, Hispanic/Latino parents, elementary school faculty, community health workers, city/state agency representatives, and local and national dental insurer representatives. Stakeholders from state and national dental insurers will support state-wide and national dissemination efforts 15
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