How Can Patient Partners Improve Joint Replacement Research? … · 2017-06-14 · Agenda What is BeTTER SAID? Welcome – 5 mins What did we learn? Findings – 15 mins How can patient
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“Research into the safety of artificial joints would be BeTTER SAID if patients are involved.”
How Can Patient Partners ImproveJoint Replacement Research?
TomConcannonRAND CorporationTufts School of Medicine
BenNowellGlobal Healthy Living Foundation CreakyJoints
ShilpaVenkatachalamGlobal Healthy Living FoundationCreakyJoints
Welcome!
This project is funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award (2228-GHLF).
ChrisStakeArthritisPower Patient GovernorBeTTER SAID
Agenda
What is BeTTER SAID? Welcome – 5 mins
What did we learn? Findings – 15 mins
How can patient partners improve research? Models – 60 mins National Evaluation System for Health Technology (NEST)—Implications for
Arthroplasty Research and Surveillance: Rachael Fleurence, PhD Patient Panel Input into ACR/AAHKS Treatment Guidelines: Susan Goodman, MD
How can you get involved? Patients + Researchers – 5 mins
Bringing STakeholders Together for Engagement in Research for the Selection of Arthroplasty Implant Devices (BeTTER SAID)
What is BeTTER SAID?Bringing STakeholders Together for
Engagement in Research for the Selection of Arthroplasty Implant Devices
We engaged stakeholders in 3 steps
Research Information Decision
Step 1. Interactive webinars to explore patient decisions and information needs prior to surgery
Step 2. In-person roundtables to observe the response of clinicians, health systems leaders, industry to patient decisions and information needs
Step 3. Disseminating webinar to share observations with patient ambassadors and other stakeholders
What did we learn?FINDINGS
Among people who were considering having hip and/or knee replacement surgery…
Percentage who want to be informed about the specific implant device
88%
Percentage who want to hold or see a model of their device
71%
Percentage interested in learning about the risks and benefits associated with surgery
88%
Percentage who want to learn about other existing devices on the market
88%
Among people who have had hip and/or knee replacement surgery…
Percentage who were informed about specific implant device
63%
Percentage who saw or held the device 34%
Percentage who learned about the risks and benefits associated with surgery
55%
Percentage who learned about other devices 18%
Important Decisions – Patient PerspectiveSurgery — Whether to have hip/knee joint replacement surgery (arthroplasty)
Timing — When to have surgery
Surgeon — Which surgeon will perform surgery
Facility — Where surgery will be performed (e.g., geographic location, specific hospital or medical center)
Device — Which implant device will be installed during surgery
Approach — Specific approach to surgery (e.g., anterior vs. posterior, bilateral joint replacement)
Other HCPs — Who/which other health care professionals (HCPs) besides the surgeon will be involved in care during and after surgery (e.g., anesthesiologist, physical therapist)
Other Services — What other services will be necessary before, during or after surgery (e.g., mental health)
Which decisions need more information?
Important Decisions – Patient PerspectiveSurgery — Whether to have hip/knee joint replacement surgery (arthroplasty)
Timing — When to have surgery
Surgeon — Which surgeon will perform surgery
Facility — Where surgery will be performed (e.g., geographic location, specific hospital or medical center)
Device — Which implant device will be installed during surgery
Approach — Specific approach to surgery (e.g., anterior vs. posterior, bilateral joint replacement)
Other HCPs — Who/which other health care professionals (HCPs) besides the surgeon will be involved in care during and after surgery (e.g., anesthesiologist, physical therapist)
Other Services — What other services will be necessary before, during or after surgery (e.g., mental health)
Which decisions need more information?
Providers Patients Payers Purchasers Policy makers Product makers Principal investigators
Who makes the decision about device?
Patients Payers Product makers
Who is affected by the decision?
“7 Ps” framework from Concannon et al JGIM 2012
How can patient partners improve research?
MODELS
National Evaluation System for health Technology (NEST)
Improving evidence generation around medical devices
www.MDIC.org
Rachael L. Fleurence, PhDExecutive director NESTcc
May 17, 2017
Created to support move to better, faster, cheaper evidence generation for medical devices throughout the total product life cycle for patients, clinicians, industry, regulatory agencies and other stakeholders
Mission to: Ensure safety for patients Expedite access to safe and effective medical devices Enable innovation
The National Evaluation System for health Technology (NESTcc)
In September 2016 FDA awarded a $3M grant for the NESTcc to the Medical Device Innovation Consortium (MDIC) with an expected $6M per year for five years from MUDFA
The NESTcc organizationalstructure fits within MDIC’s governance model:
Moving from passive surveillance to active real time surveillance
Leveraging better, faster, cheaper RWE to support regulatory decisions
Making better use of data generated in the course of clinical care or by patients themselves
Moving away from lengthy, one-off, cost-prohibitive studies to an ecosystem that supports more routine evidence generation
NESTcc’s vision is to support a paradigm shift to resolve challenges in our current system
Many sources of Real-World Data can support the paradigm shift but strong methods are essential
Real-World Data (RWD) includes data collected from sources outside of traditional clinical trials and Real-World Evidence (RWE) is the evidence derived from aggregation and analysis of RWD elements
Sources and Types of RWD
Medical Device-Produced Data
Patient Data Tracking
Industry Sponsored Studies and Registries
Adverse Event Reporting (e.g. MDR
Reporting)
Hospital Administrative Data
Clinical Data from Electronic Health
Records
Hospital Billing Data
Logistics Supply Chain Data
Social Security, DEATH Index, Census, Socio Economic Data
Claims Data (CMS and Private Payers)
Public Registries (e.g. NCDR)
Patient Reported Outcomes
Wearable Devices
Disease Risk Assessments
Patient Requested Data
Industry Institutions Public Sources Patients
Safety and Effectiveness
Monitoring
Real-World Evidence Heat MapTo gain a better understanding of the activity of RWE application across the TPLC, a heat map was developed using case studies shared by stakeholders and or collected during research
Disease Area
TPLC Phase
Ideation &Discovery
Invention &Prototpying Pre-Clinical Trial Design Feasibility
Pre-MarketComparativeEffectiveness
De NovoClassification
Cost-Effectiveness
Post-MarketSafety and/orEffectiveness
Post-MarketComparativeEffectiveness
Effectivenessin Subpop.
Applicationsin Patient
Care MethodsAnesthesiology,General Hospital,Respiratory, InfectionControl, and Dental
Cardiovascular
Cross-Cutting
In Vitro Diagnostics
Neurological AndPhysical Medicine
Ophthalmic and Ear,Nose, and Throat
Orthopedics
Reproductive,Gastro-Renal, andUrological
Surgical 3
5
2
2
2
5
3
1
24
1
9
1
5
1
4
1
3
2
2
2
2
26
1
2
4
1
1
1
10
11
Sh t 1
-0.53 26.00
Number of Cases
0 26
RWE Applications Across Total Product Lifecycle
Dis
ease
Are
a
The NESTcc will be exploring how to improve evidence generation for medical devices over next year
The developments will be of interest for patients and clinicians, medical device industry, payers, regulators, hospitals
Involvement and support from the patient community in all aspects of the work will be important for success !
Short term goals are (1) putting governance in place, (2) identifying demonstration projects and (3) developing a sustainability plan.
NESTcc: Stay tuned for future developments as we launch !
Learn More about MDIC and NESTVisit our website at: http://mdic.org
The Experience of the ACR/AAHKS PerioperativeMedication Management Guideline Project
Susan M Goodman, MD
Incorporating Input from a Patient Panel into Treatment
Guidelines
ACR-AAHKS Guideline for the Perioperative Management of Anti-rheumatic Medications in Patients with Rheumatic Diseases Undergoing Elective Total Hip or Knee Arthroplasty
Infection is a significant risk for rheumatic disease patients undergoing THA or TKA
Medication management may mitigate riskGuidance is needed for common clinical situations even
where data are sparse
Why involve patients? Patients are major stakeholders
Patients and doctors may have different priorities for outcomes and risks of therapies
Physicians were able to identify their patients’ choices for “most important” physical health outcomes 62%
Taking patients’ preferences into account may lead to increased patient compliance, adherence, and satisfaction
Kwoh AC&R 2001
Perspectives vary
Bartlett ARD 2012
Literature Review team
Expert voting panel
Define:Scope of the ProjectResearch Questions
Core team and content experts(Including 2 patients)
GUIDELINEImplementation
Guideline Development When are patients involved?
Patients reach the same conclusions as physicians
Recommendations can be strong Interventions that improve health Little risk of adverse events Convenient and low cost For patients, almost all would select MDs almost all would recommend
High Quality Evidence
Patients’ values and preferences are particularly important when…..Quality of the evidence is not highTrade-offs between benefits and harms are closely
balanced Conditional recommendations: the majority of
informed patients would follow, others would not Recommendations in these situations may be value and
preference sensitiveThe patients’ perspective may have strong influence
on the direction and strength of the recommendations
How do you incorporate patients into projects?
It is not established how to incorporate patients’ perspectives into projects:Include patients on panels?Will they be drowned out? Feedback: they don’t feel empowered to speak upWill they be representative?
Conduct focus groups?
Values and preferencesElicited to give weight to the balance between benefits and
harms Specifically queried on the relative importance of infections,
compared to the importance of flares Encouraged to consider their personal experiences relevant
to the questions and judge the importance of the outcomes accordingly , using their experience as their evidence base
They strongly and unanimously felt flares, which were common, were much less important than infection
Patients rated the importance of infection as far greater than 10-20:1, despite the relative frequency of flares vs. infection
The patients felt that flares represented a “known risk” that they could control there is no “average” infection – only very bad ones, with a risk of much
worse outcomes than flares the perioperative period is a “job” “dealing with a flare was simply part of the hard work.” “I always assume I will be in a flare when I enter surgery and for a while
when I come out, but I’m afraid of infection”. “I always expect to flare.”
Flare vs. Infection
ConclusionsPatients’ preferences were elicited prior to the
decisions of voting panel, and presented to themGuideline demonstrated clear benefit of patient input
in the presence of relatively weak evidence base in shaping the strength and direction of the decisions made by a physician voting panel
Formally determining values and preferences of patients led to patient-centric recommendations that were congruent for patient and physician panels
Findings of this project support formal incorporation of information elicited from separately convened patient panels into clinical practice guidelines
How can you get involved?
PATIENTS + RESEARCHERS
We do this for two reasons: It’s the right thing to do (i.e., helps us achieve intrinsic goods like
justice, equity, autonomy, self determination, and accountability for public dollars)
It can change research (i.e., make research more relevant, understandable and useful)
To do it the right way: Requires commitment on the part of other stakeholders Requires training of not just patients, but other stakeholders No single model is the “right” model for patient involvement
Patients can be partners in research
Program of Involvement:Guiding Questions1. How do you establish a distinction between studying patients and
involving patients?2. Why do you involve patients? (e.g., what's the ethical and scientific
rationale?)3. Do you train patients before you get started? If so, why/how?4. Does your team need training to work with patients as partners? 5. What are specific research activities in which you seek the
involvement of patients? (e.g., before, during or after, or across all phases?)
6. At what level of intensity do you involve patients? 7. What are the specifics of how you will interact with stakeholder
groups?
How would you involve stakeholders?
Group work TelephoneWebinars Focus Groups
Staff meetings Surveys Technical advisory rolesDocument review and comment Data analysis
Telephone Email InterviewsConsensus building exercises Voting exercises
Individual work Multi-stakeholder meetingsProject leadership Patient only
Before Research During Research After Research
?
Researchers
If you’re a researcher, how can you involve patients as partners to study joint replacement?
Engage with the BeTTER SAID cohort 10+ BeTTER SAID participants are Patient Partners in Research Contact Ben at bnowell@ghlf.org
Partner with patient-powered research networks like www.ArthritisPower.org
Patients
If you’re a patient, how can you get involved?
Become a Patient Partner in Research with CreakyJoints for training and activation
Research 101 session Contact Shilpa at svenky@ghlf.org or (646) 427-7891
Get involved with patient-powered research at www.ArthritisPower.org
Thank you for participatingin this discussion!
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