Cadth 2015 a5 1 pt engage symp marshall cadth apr 13 2015 present
20
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
-
Upload
cadth-symposium -
Category
Health & Medicine
-
view
31 -
download
1
Transcript of Cadth 2015 a5 1 pt engage symp marshall cadth apr 13 2015 present
The Role of Patients in Defining “value” and Engaging in Drug Development
from Bench to Bedside
1
CADTH ConferenceConcurrent Session A5
April 13, 2015Saskatoon, SK
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
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
Defining Value from the Patient’s Perspective
4
Informing Relevant Value Measurement
Deborah Marshall, PhDUniversity of Calgary
CADTH Conference April 13, 2015
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
Methods of Engagement Across International Association for Public
Participation (IAP2) Spectrum
6- Kovacs Burns et al. BMC Health Serv Res 2014, 14:175
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 andAppropriate 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 PatientEngagement
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 EngagementN=74 published and N=193 unpublished articles/items
- Kovacs Burns et al. BMC Health Serv Res 2014, 14:175
Multidimensional Framework for Patient Engagement in Health and Health Care
8
- Carman KL et al. Health Affairs 2013; 32: 223–31
CADTH Patient Input Process Review, April 2013
9- https://www.cadth.ca/sites/default/files/pdf/2012_SECOR_Patient-Input-Review_e.pdf
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
Patient Reported Outcomes (PRO)
Clinician Reported Outcomes (ClinRO)Observer Reported Outcomes (ObsRO)
2011, FDA WorkshopClinical Outcome Assessments (COAs)
Treatment benefit demonstrated by positive impact on survival or on how patients feel or function in daily life
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
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
2. Customization based on patient needs and values
3. The patient as the source of control
4. Shared knowledge and free flow of information
5. Evidence-based decision making
- Institute of Medicine. Crossing the Quality Chasm: A New Health Systemfor the 21st Century, 2001.
- ISPOR Connections 2013; Vol 19(2)
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 WorkshopClinical Outcome Assessments (COAs)
Treatment benefit demonstrated by positive impact on survival or on how patients feel or function in daily life
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
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
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?
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.
“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.
