1. Presentation Developed for the Academy of Managed Care Pharmacy
Comparative Effectiveness Research (CER) and Patient-Centered Outcomes Research (PCOR)
Presentation Developed for the Academy of Managed Care Pharmacy
Updated February 2014

2. Topics Covered Background Definitions Goals of CER and PCOR
Stakeholders
Funding sources
Challenges
CER study design and user tools

3. 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.

4. 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.

5. 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.

6. 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.

7. Stakeholders Patients: Providers: Managed care organizations:
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

8. 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

9. 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

10. CER Study Design and User Tools
Individual studies:
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:
AMCP CER Certificate Program

11. AMCP CER Certificate Program
Advance evidence assessment expertise with new research designs and study data
Learn about tools to help assess current questions in real-world 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
Additional information about the CER Certificate Program can be found on the AMCP website under “Professional Practice” and “Formulary Decision Support Tools”

12. References
Patient-Centered Outcomes Research Institute (website). Accessed on: March 21, Available at:
Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA Apr;307(15):
Institutes of Medicine. Initial national priorities for comparative effectiveness research. June 30, Accessed on: March 21, Available at:
The Henry J. Kaiser Family foundation. Explaining health reform: what is comparative effectiveness research? October Accessed on: March 21, Available at:

13. Thank you to AMCP members Carly Rodriguez and Cheryl Kaltz for creating this slide deck.