Download CER and PCOR - Academy of Managed Care Pharmacy

Comparative Effectiveness
Research (CER) and PatientCentered Outcomes Research
(PCOR)
Presentation Developed for the
Academy of Managed Care Pharmacy
Updated February 2014
Topics Covered
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Background
Definitions
Goals of CER and PCOR
Stakeholders
Funding sources
Challenges
CER study design and user tools
Background
• Early draft of the Affordable Care Act (ACA) included provisions
for comparative effectiveness research (CER).
– “CER” changed to “Patient-Centered Outcomes Research” in
legislation based on voter input
– Many entities view terms as interchangeable; however, the
definitions do differ
• ACA established a Patient-Centered Outcomes Research
Institute (PCORI)
– Funded through the general fund of the US treasury and in small
part by assessments on Medicare, private health insurance, and
self-insured plans.
Definitions
• CER and PCOR are not synonymous
• CER
– Includes any type of medical or pharmaceutical intervention (e.g. lab
tests, procedures, medications, etc.)
– Institutes of Medicine (IOM): generation and synthesis of evidence
that compares the benefits and harms of alternative methods to
prevent, diagnose, treat, and monitor a clinical condition or to improve
the delivery of care.
– Kaiser Family Foundation: compares two or more different methods
for preventing, diagnosing, and treating health conditions. Such
research is performed using methods such as practical clinical trials,
analyses of claims records, computer modeling, and systematic
reviews of existing literature.
Definitions
• PCOR
– PCORI’s working definition states that PCOR:
• Assesses the benefits and harms of preventive, diagnostic, therapeutic,
palliative, or health delivery system interventions to inform decision
making, highlighting comparisons and outcomes that matter to people;
• Is inclusive of an individual’s preferences, autonomy and needs, focusing
on outcomes that people notice and care about such as survival, function,
symptoms, and health related quality of life;
• Incorporates a wide variety of settings and diversity of participants to
address individual differences and barriers to implementation and
dissemination; and
• Investigates (or may investigate) optimizing outcomes while addressing
burden to individuals, availability of services, technology, and personnel,
and other stakeholder perspectives.
Goals of CER and PCOR
• CER and PCOR definitions differ, but goals are similar
• CER:
– IOM: assist consumers, clinicians, purchasers, and policy makers to
make informed decisions that will improve health care at both the
individual and population levels.
– Kaiser Family Foundation: improve health outcomes by developing and
disseminating evidence based information to patients, providers, and
health care decision-makers about the effectiveness of treatments
relative to other options. Identifying the most effective and efficient
interventions has the potential to reduce unnecessary treatments,
which in turn, may help lower costs.
• PCOR:
– PCORI: help people and their caregivers communicate and make
informed healthcare decisions, allowing their voices to be heard in
assessing the value of healthcare options.
Stakeholders
• Patients:
– Understand risks/benefits of treatment options
– Make informed healthcare decisions
• Providers:
– Make informed treatment recommendations
– Facilitate patient-shared decision-making
• Managed care organizations:
– Support benefit/formulary changes
– Educate members and providers
• United States Healthcare System
– Improve health of U.S. population
– Decrease variability in clinical practice across the country
– Decrease healthcare costs
Funding Sources
– To date, most CER and PCOR projects have been
funded through grants
• PCORI
– Awards research grants for PCOR from federal funds
• US Department of Health & Human Services (HHS)
– Agency for Healthcare Research and Quality (AHRQ)
– Funding to train researchers to conduct CER and
PCOR has been provided by
• The PhRMA Foundation
Challenges
• CER and PCOR require special skill sets:
– Researchers
• Focus on new approaches to research to inform decision making by patients
and caregivers
– Educators
• Training researches to conduct CER and PCOR
– Clinical decision-makers and
• Assessing the validity and applicability of CER and PCOR output
• Interpreting and applying the resulting body of evidence
– Policy-makers
• Establish policy based on a body of evidence that is valid and applicable to
their population
– Payers
• Make payment decisions based on the most effective treatment options based
on individual patient characteristics
CER Study Design and User Tools
• Study design:
– Individual studies:
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Prospective randomized or observational trials
Retrospective observational trials
Indirect treatment comparisons
Network meta-analyses
Modeling studies
– Evaluate the overall body of evidence
• User tools:
– AMCP/ISPOR/NPC collaborative: www.cercollaborative.org
– AMCP CER Certificate Program
AMCP CER Certificate Program
• Advance evidence assessment expertise with new research
designs and study data
• Learn about tools to help assess current questions in realworld settings
• Certificate Program Details
– 19 Credit Hours
– Five - Online Modules
– One – 4 hour workshop – with live presentations at one of
AMCP’s national meetings
– Student Fee $400
References
1. Patient-Centered Outcomes Research Institute (website).
Accessed on: March 21, 2014. Available at:
http://www.pcori.org/
2. Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes
Research Institute (PCORI) national priorities for research
and initial research agenda. JAMA. 2012 Apr;307(15):1583-4.
3. Institutes of Medicine. Initial national priorities for
comparative effectiveness research. June 30, 2009. Accessed
on: March 21, 2009. Available at:
http://www.iom.edu/Reports/2009/ComparativeEffectivenes
sResearchPriorities.aspx
4. The Henry J. Kaiser Family foundation. Explaining health
reform: what is comparative effectiveness research? October
2009. Accessed on: March 21, 2014. Available at:
http://kff.org/health-costs/issue-brief/explaining-healthcare-reform-what-is-comparative/
Thank you to AMCP members
Carly Rodriguez and Cheryl Kaltz
for creating this slide deck.