Cadth 2015 a5 1 pt engage symp marshall cadth apr 13 2015 present
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Cadth 2015 a5 1 pt engage symp marshall cadth apr 13 2015 present
- 1. The Role of Patients in Defining “value” and Engaging in Drug Development from Bench to Bedside 1 CADTH Conference Concurrent Session A5 April 13, 2015 Saskatoon, SK
- 2. Session Overview • Canadian HTA agencies are accepting formal patient input in their review process. • The need for patient involvement in the design of effective value measures throughout the drug development cycle to support stronger reimbursement and policy decisions is increasing. – What key questions should be asked to measure the impact of a medication on the life of the patient? – How should the information required to answer these questions be collected? – How should this information used to make decisions about funding? 2
- 3. The Panel Lineup • Deborah Marshall - Associate Professor and Canada Research Chair, Health Services and Systems Research , University of Calgary • Louise Binder - Cofounder of the Canadian Treatment Action Council and Project Manager for Carcinoid NeuroEndocrine Tumour Society (CNETS) • Pauline McNulty - Vice President, Global Market Access and Commercial Strategy Operations at Janssen Pharmaceutical Companies of Johnson & Johnson. • • Ken Bond - Director, Strategic Initiatives CADTH • Laura Faye - Manager (Acting), JRMS Department, Acute and Ambulatory Care Information Services at the Canadian Institute for Health Information. 3
- 4. Defining Value from the Patient’s Perspective 4 Informing Relevant Value Measurement Deborah Marshall, PhD University of Calgary CADTH Conference April 13, 2015
- 5. Outline 1) Alternative Approaches to Patient Engagement 2) Redesigning Drug Development to be Patient-Centered 3) Introducing Patient and Community Engagement Researchers (PACERs) as an approach to relevant value measurement 5
- 6. Methods of Engagement Across International Association for Public Participation (IAP2) Spectrum 6 - Kovacs Burns et al. BMC Health Serv Res 2014, 14:175
- 7. Theme Definition of Patient Engagement Citizen engagement, consumer engagement, meaningful patient involvement, participation, patient and public engagement, public involvement, patient centred care and patient involvement Stakeholder Roles and Expectations Lack of consensus and understanding about terminology, goals and expectations and roles and responsibilities as barriers to meaningful and successful patient engagement Meaningful and Appropriate Engagement Desire to ensure patient perspectives to design and improve health services, but not easy (25% want involvement in healthcare decision making, but <10% want involvement in funding decisions) Models of Engagement 19 different models of engagement across different levels of involvement (IAP2) Benefits/Barriers to Patient Engagement PE generally considered beneficial , but lack of research on this and which methods most effective (Cochrane review ) Evaluation of Patient Engagement Variety of toolkits and guides , but a lack of consensus on best approach to evaluate Engagement Resourcing Important to ensure adequate resourcing for PE including time, resources and capacity 7 Scoping Review: Patient Engagement N=74 published and N=193 unpublished articles/items - Kovacs Burns et al. BMC Health Serv Res 2014, 14:175
- 8. Multidimensional Framework for Patient Engagement in Health and Health Care 8 - Carman KL et al. Health Affairs 2013; 32: 223–31
- 9. CADTH Patient Input Process Review, April 2013 9 - https://www.cadth.ca/sites/default/files/pdf/2012_SECOR_Patient-Input-Review_e.pdf
- 10. Submission Length – 8 pages •Section 1 – General Information •Section 2 – Condition and Current Therapy Related Information •Section 3 – Related Information about the Drug Being Reviewed •Section 4 – Additional Information 10 - https://www.cadth.ca/sites/default/files/pcodr/pCODR%27s%20Drug%20Review %20Process/pcodr-patient-engagement-guide.pdf A guide to completing the pCODR Patient Advocacy Group Input on a Drug Review Template
- 11. 11 Patient Reported Outcomes (PRO) Clinician Reported Outcomes (ClinRO) Observer Reported Outcomes (ObsRO) 2011, FDA Workshop Clinical Outcome Assessments (COAs) Treatment benefit demonstrated by positive impact on survival or on how patients feel or function in daily life
- 12. Why Patient Engagement? Who is the Expert: patients and families with direct experience What is Right: morally, patients and families are the ones who affected directly What is Relevant: measure what is meaningful What Makes a Difference: better self-care, improve quality of care, better compliance, and better outcomes, how patients feel and function predicts use of health resources Patient Values ≠ System Values
- 13. Institute of Medicine: 10 Rules for Redesigning Health Care 1. Care based on continuous healing relationships Care whenever it’s needed, not just face-to-face 1. Customization based on patient needs and values 2. The patient as the source of control 3. Shared knowledge and free flow of information 4. Evidence-based decision making - Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century, 2001. - ISPOR Connections 2013; Vol 19(2)
- 14. 14 “Patient Centered Outcomes” Engage Patients to Define the Disease, Define Relevant Measures and Identify the Patients for Treatment Patient Reported Outcomes (PRO) Clinician Reported Outcomes (ClinRO) Observer Reported Outcomes (ObsRO) 2011, FDA Workshop Clinical Outcome Assessments (COAs) Treatment benefit demonstrated by positive impact on survival or on how patients feel or function in daily life
- 15. Proposition: Towards the Science of Effective Patient Engagement • Include the patient perspective in each stage of the lifecycle… – from clinical development, regulatory review , HTA evaluation, funding decisions and real world evidence; • ‘Patient Reported Outcomes’ – don’t always reflect issues that are most important to patients – need to be informed and developed with patients – and then tested and validated as outcome measures; • Embed meaningful and relevant patient measures in the value equation – Weighting of evidence from patients. 15
- 16. Patient and community engagement researchers (PACERs) are people with various health conditions, trained to design and conduct health research, using specific adapted methods of qualitative inquiry. PACER graduates work in collaboration with health professionals and researchers to: Patient and Community Engagement Research - Marlett N, Shklarov S, Marshall DA, et al. Building New Relationships in Research: A Model of Patient Engagement Research. Qual Life Res 2014; Doi: 10.1007/s11136-014-0845-y
- 17. Patients are fully engaged in: • Choosing research questions important to patients and their families and communities. • Making decisions about how to collect and analyze information. • Making decisions on how to communicate findings to other patients, professionals and the public. Rigorous training involves mastering specific adapted methods of qualitative research: focus groups, field observation, questionnaires, and narrative interviewing. A year-long training program = 120 hours in-class instruction plus an internship. How does Patient Engagement Research differ from more traditional methods?
- 18. The PACER Research Method A Collaborative Framework for Engaging Patients in Research - N Marlett and C Emes. Grey Matters. A Guide to Collaborative Research with Seniors. University of Calgary Press, 2010.
- 19. “Part of the Team”: Building New Patient Roles and Relationships in Health Research and Planning 19- Marlett N, Shklarov S, Marshall DA, et al. Building New Relationships in Research: A Model of Patient Engagement Research. Qual Life Res 2014; Doi: 10.1007/s11136-014-0845-y Model: Co-creation of PACER role Results: 3 major areas of impact: 1) increased capacity of patients to engage in healthcare research and planning, 2) effective uptake of new patient roles in health care planning – impacting attitudes and practices, and 3) introduction and acceptance of new, collaborative roles for patients in research. Interpretation: Process of merging two distinct roles of patient and researcher unleashes a force for fundamental cultural change, and a way to embed and measure patient value.
- 20. 20 Thank you ! damarsha@ucalgary.ca 403 210 6377
Notes de l'éditeur
- Canadian HTA agencies (CADTH, pCODR, ON and BC) are accepting formal patient input in their review process. This is an important opportunity for the patient’s perspective to be considered in the decision making process for funding recommendations of new medications and/or for drug class reviews. Additionally, CADTH and pCODR, have released recommendations and guidelines directed at patient groups on how to provide patient and caregiver input to a drug review. But the real challenge is to determine what key questions should be asked to measure the impact of a medication on the life of the patient and additionally how should the information required to answer these questions be collected? The engagement of patient in the development of relevant value measurements, involvement in the design of clinical programs to collect this data and the analysis and reporting of the real world evidence for consideration by HTA bodies is becoming more important. Real world evidence is being considered by HTA bodies to support their reimbursement recommendation, and could be used to support coverage with evidence building schemes. The need for patient involvement in the design of effective value measures throughout the drug development cycle to support stronger reimbursement and policy decisions is increasing. CADTH has recently given another opportunity for patient groups to voice their needs through the early advice process which suggest that CADTH plans to involve patient representatives earlier, highlighting the importance of patient involvement in the drug development process.
- General Flow – Order of speakers and timing: Dr Marshall Opening and introduction of the panelists– 5 mins Dr Marshall – 10 mins. The science behind defining patient value. Defining “value” of medicines from the patient’s perspective. Louise -10 mins: patient perspective of value. Why should we care? Pauline 10 mins: What is the role of patient engagement in clinical trial design? How can the industry ensure patient value measures are included early in the life cycle of medications Ken 10 mins: how can HTA reviews benefit from better measures of patient value and how can they influence recommendation decisions and ongoing measures of health and improve outcomes. Laura 10 mins: PROM how do they impact health policies once medications are used in the general public and what are the “right questions” to ask when determining value for patients once used, because what is good for one may not be for another. Louise Binder: Louise is a labour lawyer and co-founded and chaired the Canadian Treatment Action Council. She spent the last 20 years advising patients and patient organizations provincially, nationally and internationally on issues of health policy and particularly treatment access issues. In October 2013, Louise began consulting for CNETS Canada and, in that capacity; she is the Project Manager for the organization supporting patient and medical education programs, treatment access and health policy work, fundraising and event planning. Deborah Marshall, PhD, MHSA: Deborah Marshall holds a Canada Research Chair, Health Services and Systems Research as an Associate Professor at the University of Calgary and Arthur J.E. Child Chair of Rheumatology Outcomes Research in the McCaig Institute of Bone and Joint Health. She is the Director of Health Technology Assessment at the Alberta Bone and Joint Health Institute, a Senior Scientist of the Arthritis Research Center of Canada, and a member of the Institute of Public Health. Dr. Marshall is an active member of the International Society for Pharmaco-economics and Outcomes Research (ISPOR) as the Past President of the Board of Directors and a member Board of Directors for Health Technology Assessment International (HTAi). Pauline McNulty PhD. Pauline McNulty is Vice President, Global Market Access and Commercial Strategy Operations at Janssen Pharmaceutical Companies of Johnson & Johnson. In that role, she is responsible for ensuring the patient’s perspective is appropriately incorporated into global drug development programs through measurement of Patient Reported Outcomes (PROs). Prior to joining the pharmaceutical industry, she worked for a healthcare research and consulting company, SysteMetrics, in Santa Barbara, California. Pauline received her Ph.D. in experimental psychology from the University of California, Santa Barbara. She has an MSc in Experimental Psychology and a BSc in Science from University College Dublin. Ken Bond: Director, Strategic Initiatives CADTH. CADTH recently welcomed Ken Bond to the position of Director of Strategic Initiatives, responsible for patient engagement at CADTH. He will be working with many others to support CADTH&apos;s patient engagement processes in the Common Drug Review, pan-Canadian Oncology Drug Review, Therapeutic Review, medical devices, and early scientific advice areas. Prior to joining CADTH Ken was Research Associate at Institute of Health Economics in Edmonton. Laura Faye, PhD is Manager (Acting), JRMS Department, Acute and Ambulatory Care Information Services at the Canadian Institute for Health Information. In this role, she oversees the operations of the Patient Reported Outcome Measures (PROMs), Canadian Patient Experiences Reporting System (CPERS), Canadian Joint Replacement Registry and Canadian Multiple Sclerosis Monitoring System initiatives at CIHI. As part of CIHI’s Population Risk Adjustment Grouper initiative, Dr. Faye developed models to predict future health system utilization and costs for the Canadian population. Prior to joining CIHI, Dr. Faye led clinical trials data management teams for pharmaceutical clients as part of a contract research organization. Dr. Faye holds a Ph.D. in biostatistics from the University of Toronto and Mount Sinai Hospital and a M.Sc. in statistics.
- 74 published and 193 unpublished articles/items were retained for the final thematic content analysis. Seven themes were identified from this content analysis: Definition of Patient Engagement, Stakeholder Roles and Expectations, Meaningful and Appropriate Engagement, Models of Engagement, Benefits and Barriers to Patient Engagement Evaluation of Patient Engagement and Engagement Resourcing) Nilsen E: Methods of Consumer Involvement in Developing Healthcare Policy and Research, Clinical Practice Guidelines and Patient Information Material (review). Ottawa: The Cochrane Collaboration; 2010.
- Kristin L.Carman, Pam Dardess, Maureen Maurer, Shoshanna Sofaer, Karen Adams, Christine Bechtel, and Jennifer Sweeney, “Patient and Family Engagement: A Framework for Understanding the Elements and Developing Interventions and Policies,” Health Affairs 32, no. 2 (2013): 223–31. Note Movement to the right on the continuum of engagement denotes increasing patient participation and collaboration.
- https://www.cadth.ca/sites/default/files/pcodr/pCODR%27s%20Drug%20Review%20Process/pcodr-patient-engagement-guide.pdf
- Marshall DA. President’s Message. Giving birth to patient-centered care: Embryonic science of patient engagement needs a catalyst. ISPOR Connections. Vol 19 No 2: March – April 2013 From Crossing the Quality Chasm: A New Health System for the 21st Century Committee on Quality of Health Care in America, Institute of Medicine ISBN: 978-0-309-07280-9, 364 pages, 6 x 9, hardback (2001) Recommendation 4: Private and public purchasers, health care organizations, clinicians, and patients should work together to redesign health care processes in accordance with the following rules: 1. Care based on continuous healing relationships. Patients should receive care whenever they need it and in many forms, not just face-to-face visits. This rule implies that the health care system should be responsive at all times (24 hours a day, every day) and that access to care should be provided over the Internet, by telephone, and by other means in addition to face-to-face visits. 2. Customization based on patient needs and values. The system of care should be designed to meet the most common types of needs, but have the capability to respond to individual patient choices and preferences. 3. The patient as the source of control. Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over health care decisions that affect them. The health system should be able to accommodate differences in patient preferences and encourage shared decision making. 4. Shared knowledge and the free flow of information. Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information. 5. Evidence-based decision making. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place. 6. Safety as a system property. Patients should be safe from injury caused by the care system. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors. 7. The need for transparency. The health care system should make information available to patients and their families that allows them to make informed decisions when selecting a health plan, hospital, or clinical practice, or choosing among alternative treatments. This should include information describing the system’s performance on safety, evidence-based practice, and patient satisfaction. 8. Anticipation of needs. The health system should anticipate patient needs, rather than simply reacting to events. 9. Continuous decrease in waste. The health system should not waste resources or patient time. 10. Cooperation among clinicians. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.
- Quality of life measures often don’t reflect issues of most importance to patients Weighting on evidence from patients
- What is PACER?
- Background: This project responded to a provincial commitment to engage patients as partners by Alberta Health Services’ Strategic Clinical Networks (SCNs) – a new interdisciplinary organization to support evidence-informed improvements in clinical outcomes across the health system. This study implemented and tested a new method and curriculum of building capacity for engagement in health through peer-to-peer research. Methods: Twenty one patients with various chronic conditions completed one-year training in adapted qualitative research methods, including internship where they designed and conducted five peer-to-peer inquiries into a range of health experiences. To understand the impact, we used an Outcome Mapping framework. Analysis was based on data from focus groups, observation, documentation review, and semi-structured interviews (21 patient researchers and 15 professional collaborators). Results: Key stakeholders indicated three major areas of impact: 1) increased capacity of patients to engage in healthcare research and planning, 2) effective uptake of new patient roles in health care planning – impacting attitudes and practices, and 3) introduction and acceptance of new, collaborative roles for patients in health research. Interpretation: The new model of patient engagement, now named patient and community engagement research (PACER), has the potential to promote a patient perspective in health research and health system redesign and shows first compelling indicators of success, while it is our priority to continue fostering the program and measuring the evolution of its impact to capture the positive cultural change.