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Seeking Input on Future PROMIS® Research: Educating Patients and Stakeholders about PCORI’s Request for Information (RFI)

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  • 1. Seeking Input on Future PROMIS® Research: PCORI’s Request for Information (RFI) January 30, 2013
  • 2. Webinar Objectives 2 Describe PCORI’s unique mission and activities Describe PROMIS® Summarize PCORI’s Request for Information (RFI) seeking input on future PROMIS® research Question and answer session Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 3. Introductions: Speakers 3  Lori Frank, PhD Director, Research Integration and Evaluation Patient-Centered Outcomes Research Institute (PCORI)  Laura Lee Johnson, PhD Biostatistician, Science Officer for the PROMIS® Statistical Center National Center for Complementary and Alternative Medicine (NCCAM) National Institutes of Health  James Witter, MD, PhD, FACR Chief Science Officer for PROMIS® Medical Officer/Rheumatic Diseases Clinical Program National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS) National Institutes of Health Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 4. PCORI’s unique mission and activities
  • 5. About PCORI 5 An independent non-profit research organization authorized by Congress as part of the 2010 Patient Protection and Affordable Care Act (ACA). Committed to continuously seeking input from patients and a broad range of stakeholders to guide its work. Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 6. Why PCORI? 6 Patients have questions that research can answer People want to know which treatment is right for them Patients need information they can understand and use Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 7. Our Mission Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information 7 PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.
  • 8. Research PCORI Supports Comparative Effectiveness Research (CER)  Patient-centered  Answering questions that matter to patients and other healthcare decision makers Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information 8
  • 9. PCORI Merit Review Process PCORI review committees include scientists, patients, and other stakeholders to bring diverse perspectives to the review process. PCORI’s unique merit review criteria ensure that research funded by PCORI is scientifically rigorous and patient-centered. Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information 9
  • 10. Merit Review Criteria 1. Impact of the condition on the health of individuals and populations 2. Potential for the study to improve healthcare and outcomes 3. Technical Merit 4. Patient-centeredness 5. Patient and stakeholder engagement 10 Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 11. Our Growing Research Portfolio 11 Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information Total number of research projects awarded to date: 297 research projects Total funds committed to date: $464 million Number of states where we are funding research: 41 states
  • 12. Background & Opportunities January 30, 2014 James Witter, MD, PhD, FACR: NIAMS/NIH Laura Lee Johnson, PhD: NCCAM/NIH Dynamic Tools to Measure Health Outcomes from the Patient Perspective
  • 13. Click to edit Master title style Vision and Mission • Vision – The Patient-Reported Outcomes Measurement Information System (PROMIS®), funded by the National Institutes of Health, aims to provide clinicians and researchers access to efficient, precise, valid, and responsive adult- and child-reported measures of health. • Mission – PROMIS uses measurement science to create an efficient state-of-the-art assessment system for self-reported health.
  • 14. Click to edit Master title style
  • 15. PROMIS Resources Advancing Knowledge >240 Peer-Reviewed Articles >100 journals >40,000 participants >10,000 children Informatics Assessment Center Supports >800 active studies in past year alone Tools (30 domains) 40+ Adult Measures 20+ Pediatric Measures Translations Goal 100%  Spanish (Over 40 other languages) Cooperative Group 12 Research Sites 3 Centers 150+ Scientists NIH funding (>$100M) Numerous RFAs and supplements since 2004 to support Center & Sites Applications Assess health domains of patients and healthy people in clinical trials and research as well as healthcare delivery and population surveys
  • 16. Click to edit Master title style Advancing Patient-Centered Outcomes PROMIS: A Common Standard of PROs Clinical Practice Clinical research Surveys (CDC, NIH) NIH FDA Clinic Hospital Industry
  • 17. Click to edit Master title styleClick to edit Master title style Common Resource To Advance Patient- Centered Outcomes •Patient-Centered •Cross Sectional •Cognitive testing •Focus groups Psychometrically focused testing Clinically focused testing Fully develop domain Fully test domain •Patient Centered •Longitudinal •NIH studies •Industry studies •National surveys •Clinical care •Web based follow-up
  • 18. Click to edit Master title style PROMIS® Combines • Item Response Theory (IRT) and Computer Adaptive Testing (CAT) • Together, IRT and CAT provide precise measurement of individual symptoms
  • 19. Low High Levels of Physical Function Item Difficulty IRT models Latent Traits: People and Items Represented on the Same Scale Are you able to run 5 miles Are you able to get out of bed Low High
  • 20. Click to edit Master title style Computerized Adaptive Testing (CAT) Integrates IRT with computers to administer a PRO instrument • Selects questions on the basis of a patient’s response to previously administered questions • Measurement is “adapted” to individual • Skips uninformative items to minimize response burden • Allows determination of person’s standing on a domain without a loss in measurement precision
  • 21. Computer Adaptive Testing: An Illustration 0123-1-2-3 high physical function 012 Question #2 12 Question #3 High Precision Minimal Respondent Burden low physical function Question #1
  • 22. Click to edit Master title styleClick to edit Master title style
  • 23. Click to edit Master title style Evolving Concept of Health DOMAIN (widely or universally relevant) vs. DISEASE attributable
  • 24. Click to edit Master title style PROMIS Adult Fatigue Bank • The fatigue (95) item bank evaluates a range of self-reported symptoms – Mild subjective feelings of tiredness – Overwhelming, debilitating, and sustained sense of exhaustion – Decreases one’s ability to execute daily activities and function normally in family or social roles
  • 25. Fatigue Item Bank Lower Back Pain Same metric, same meaning Depression Heart Failure Cancer COPD
  • 26. PROMIS Measures Tested in Six Conditions Condition Relevant Item Banks COPD Physical Function Fatigue Pain Social Role Satisfaction Emotional Distress (Depression, Anxiety, Anger) Heart Failure Physical Function Fatigue Social Role Satisfaction Depression Low Back Pain Pain (Interference and Behavior) Physical Function Depression Fatigue Sleep Disturbance Depression Emotional Distress (Depression, Anxiety, Anger) Sleep Disturbance Fatigue Physical Function Pain Arthritis Physical Function Cancer Pain Fatigue Emotional Distress (Depression, Anxiety) Physical Function
  • 27. Click to edit Master title style The PROMIS Metric T Score Mean = 50 SD = 10 Reference: US General Population
  • 28. 5035 40 45 55 60 65 PROMIS Fatigue Across Five Clinical Conditions Average for General Population COPD Stable (B) COPD Exacerbation (B) Exacerbation to Stable N = 125
  • 29. 5035 40 45 55 60 65 PROMIS Fatigue Across Five Clinical Conditions Average for General Population COPD Stable (B) COPD Exacerbation (B HF Pre-transplantHF Post-transplant Exacerbation to Stable Depression (B) Depression (1 mo) Depression (3 mos) Cancer Chemo (B) Cancer w/ benefit (2 mos) Back Pain (B) Back Pain (1 mo) Back Pain (3 mos) N = 64 N = 310 N = 114 N = 229 N = 125
  • 30. Click to edit Master title style Child-Adult Linkage Studies • Render child and adult editions comparable • Same scale • Enable life course outcome assessment
  • 31. PROMIS® Profile Short Forms (29-43-57 items) (+ pain intensity) Anxiety 29 Depression 28 Fatigue 95 Pain Interference 41 Sleep Disturbance 27 Physical Function 86 Satisfaction with Roles 14 4 6 8 Mental Physical Social
  • 32. Click to edit Master title style Sample Question • PROMIS Short Form v1.0 – Physical Function 12a • Are you able to get in and out of bed? – Without any difficulty – With a little difficulty – With some difficulty – With much difficulty – Unable to do • http://www.nihpromis.org/measures/SampleQuestions
  • 33. Click to edit Master title style Assessment Center • Online research management tool • Enables study-specific websites – Secure data capture • Clinical studies can be customized • Includes PROMIS instruments – Short forms, CATs, and Profiles • Detailed statistical/development history • Real-time scoring • www.assessmentcenter.net
  • 34. assessmentcenter.net
  • 35. Click to edit Master title style Demonstrated Capacity and Future Interest Current Usage • Over 3,000 registered research users • Over 800 active PRO research protocols • Over 6.5 million patient responses collected Additional Interest • Competitive grants funded • PROMIS short forms in REDCap library • Epic and other EHR vendors • NIH Clinical Center, Cleveland Clinic, other clinical settings • US Department of Defense
  • 36. PROMIS can be used with different modes of administration
  • 37. Click to edit Master title style Clinical Settings and Systematic Integration of PROs • Broderick, J. E., Morgan DeWitt, E., Rothrock, N., Crane, P. K., & Forrest, C. B. (2013). Advances in patient reported outcomes: The NIH PROMIS measures. eGEMs, 1(1), article 12. http://repository.academyhealth.org/egems/vol1/iss1/12/ • Examples – Cleveland Clinic, University of Washington, Cincinnati Children’s Hospital, Northwestern University
  • 38. Click to edit Master title style University of Washington Outpatient HIV Clinic • PRO measures integrated into clinic visits • Allotting time prior to the visit for assessment • General health-related quality of life • PRO measures have drawn provider attention to depressive symptoms, poor medication adherence, and at-risk behaviors
  • 39. Click to edit Master title style Cincinnati Children’s Hospital Medical Center • Using PROs in 12 subspecialty clinics • System-wide rollout planned • Over time will monitor health of the medical center’s population as a whole by assessing general health-related quality of life
  • 40. Click to edit Master title style Kaplan et al Associate Change in Treatment for Inflammatory Bowel Disease with Outcomes • Using individual patients as the unit of measure • Mobile and web-based data collection of PROMIS and other measures • Generated graphical display of PRO data with statistical process control charts • Determine when changes in medical therapy were reflected in meaningful changes in PROs • Used the data to identify the most effective treatment for a given patient in order to deliver personalized care
  • 41. Click to edit Master title style Robert H. Lurie Comprehensive Cancer Center of Northwestern University • PROMIS CATs screen for distress, other outcomes, conduct needs assessment in gynecologic oncology patients • Complete measures via EHR patient portal before visit • Scores exceeding an established threshold or requests for services generate messages within EHR for appropriate clinical care team member • Addresses accreditation standard set by American College of Surgeons Commission on Cancer for routine screening of distress
  • 42. CAT Graph
  • 43. Click to edit Master title style Contributions to Future Clinical Research & Care • Precision – improved measurement precision across the full range of patient-reported outcomes • Efficiency – less respondent burden • Standardization – more interpretable research with standard terminology and metrics • Common language between research and practice fosters CER • International clinical trial applications
  • 44. Click to edit Master title style PROMIS: The Road Ahead • Person-Centered Outcomes Research Resource (PCORR) – http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-13-008.html – Trans-NIH – PROMIS, NIH Toolbox, Neuro-QoL, ASCQ-Me • Using patient-centered outcomes • Transition to long-term sustainability • Ongoing implementation and validation – Investigator Initiated R01s – NIH issued Funding Opportunity Announcements
  • 45. Click to edit Master title style Where to Find More Information • PROMIS www.nihpromis.org – FAQs, publications, instructional videos – Twitter (@promisNIH) – Newsletter • Assessment Center http://www.assessmentcenter.net/ • Assessment Center Help Desk (help@assessmentcenter.net)
  • 46. Summary of PCORI’s Request for Information
  • 47. Purpose of this RFI Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information 54 Gather input and ideas about opportunities for future research related to PROMIS®  Opportunities for supporting and/or expanding existing PROMIS® research areas  Opportunities for supporting new research incorporating PROMIS® measures Submissions to the RFI will assist PCORI with understanding the healthcare community’s perspective on opportunities to support PROMIS-focused research.
  • 48. RFI Submitters PCORI is interested in input from stakeholders who use or may use PROMIS® measures including:  Patients/Consumers  Caregivers/Family members of patients  Patients/Caregiver Advocacy Organizations  Clinicians  Clinics/Hospitals/Health Systems  Purchasers  Payers  Industry  Researchers  Policy Makers  Training Institutions Seeking Input on Future PROMIS Research: Educating Stakeholders about PCORI’s Request for Information 55
  • 49. Information Requested Research gaps in patient-centered CER for which PROMIS® measures could contribute to outcomes assessment Opportunities to expand use of PROMIS® measures in clinical care  This may include opportunities related to platforms for clinical use of PROMIS® measures Opportunities to evaluate performance of PROMIS® item banks across diverse clinical populations and settings Seeking Input on Future PROMIS Research: Educating Stakeholders about PCORI’s Request for Information 56
  • 50. Information Requested (continued) Opportunities to develop new item banks within PROMIS® to aid with evaluation of care quality and the patient experience of clinical care Opportunities to maintain or expand the PROMIS® infrastructure with a focus on models for sustainability Opportunities for use of PROMIS® measures in regulatory approval for new drugs, devices, and diagnostics, including opportunities for measure qualification by the Food and Drug Administration. Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information 57
  • 51. Submission Guidelines 58 Available on PCORI’s website: http://www.pcori.org/assets/2014/01/PCORI-RFI- PROMIS-011514.pdf Responses due by 5 p.m. (ET) on Feb. 12, 2014 E-mail responses to PROMISRFI@pcori.org All responses must include:  Names of submitter(s)  Organization affiliation(s) if applicable  Contact e-mail address(es) and phone number(s) Consenting submitters may be acknowledged by name on PCORI’s website or in PCORI events Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information
  • 52. Question and answer session
  • 53. Thank you! 60 Acknowledgements  NIH staff Stay current with email alerts at http://www.pcori.org/home/signup and follow us on Twitter @PCORI Please send questions or comments to: Lori Frank, PhD Director of Research Integration and Evaluation lfrank@pcori.org Seeking Input on Future PROMIS® Research: Educating Stakeholders about PCORI’s Request for Information

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