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What Is CER?
Comparative Effectiveness Research (CER) seeks to determine which medical interventions and strategies work best, for whom, and under what circumstances. See more information about and definitions of CER
Most definitions of CER involve not only comparing two or more active interventions, but also
- conducting these assessments in settings with real-world significance
- evaluating for heterogeneity of intervention effects across different subgroups of patients
- focusing on perspectives of different stakeholders, with a particular emphasis on patient-centered outcomes.
Consultation Pathway for CER
UCSF investigators may be eligible to receive up to 6 free hours of consultation to support the development of proposals for Patient Centered Outcomes Research Institute (PCORI) funding.
Consultation Opportunities Related to CER
Investigators who are not eligible for the expanded suite of no-cost consultations have access to these resources via the standard one hour free consultation with additional hours charged per the Consultation Services Recharge Policy.
- Community-Engaged Research
- Stakeholder engagement: A key criterion by which applications to PCORI are judged is the level of stakeholder engagement with the proposed project, including the active participation of stakeholders in developing the proposal.
- Recruitment of study subjects: Connect with community-based clinicians and clinics interested in participating in research.
- Participant Recruitment & Study Management — Access a variety of services to support identification and recruitment of study subjects as well as project management and regulatory support.
- Biostatistics — Biostatistical issues that often rise in CER studies include causal inference models.
- Study Design — Issues include design of pragmatic clinical trials, adaptive trial designs, and design of studies using secondary data analysis approaches.
- Working with Large Datasets — Find expertise in and access to high-value datasets for Comparative Effectiveness Research.
The consultation pathway for CER may also include these services:
- Exercise and Body Composition Laboratory — Patient-centered outcomes are outcomes that are perceived as directly important to patients. For example, quality of life and ability to work or walk two blocks may be more important to patients than their LDL cholesterol or interleukin levels. While patient-centered outcomes will vary between studies, a common, important patient-centered outcome is physical function. The Exercise and Body Composition Laboratory provides resources and training for investigators interested in employing functional measures in their studies.
- Cancer Center — Kathryn Phillips, PhD directs a program to help investigators interested in CER related to cancer.
- The San Francisco Coordinating Center provides infrastructure support for multicenter studies and clinical trials.
- The San Francisco Branch or the United States Cochrane Center supports the development of systematic reviews and meta-analyses.
Additional UCSF Services
How to Write a PCORI Grant
A free online mini-course on key elements of applying for PCORI funding — faculty, trainees, and staff at UCSF, the Kaiser Permanente Department of Research, Palo Alto Medical Foundation Research Institute, or Children's Hospital Oakland are welcome to participate.
PCORI Proposal Library
Learn by example — view examples of successful UCSF proposals generously provided by members of the UCSF community (UCSF access only).
Comparative Effectiveness Large Datasets
A database inventory of over 80 local and national health datasets searchable by domain, population, time frame, study design, and unit of observation supports investigators interested in assessing comparative effectiveness of clinical and other interventions.
- Access the inventory
- Find facts and figures for your proposal, manuscript, and presentation background
- Get expert consultation on working with large datasets
Other UCSF Resources and Information
- Steering Committee charged with coordinating and supporting Comparative Effectiveness Research (CER) at UCSF
- In 2011 Michael Steinman was appointed Director of Comparative Effectiveness Research for UCSF's CTSI
- Needs Assessment for Comparative Effectiveness Research at UCSF, conducted Spring 2011: Survey (pdf 130KB) and Final Report (pdf 220KB)
UCSF Courses and Presentations
The UCSF Department of Epidemiology and Biostatistcis provides a wide range of courses relevant to CER including clinical trials, epidemiology, systematic reviews, and biostatistics. Courses of particular relevance include:
- Advanced Approaches to the Analysis of Observational Data
- Clinical Performance and Health Outcomes Measurement
- Epidemiologic Methods II
Archived presentations of UCSF symposia and lectures by UCSF faculty:
- UCSF Comparative Effectiveness Research Symposium 2014: Getting your Research Funded by PCORI - A View from the Inside
- Slidesets & Manuals
- David Hickam, MD, MPH, PCORI – PCORI’s Approach to Providing Support for Comparative Effectiveness Research
- Mary Whooley, MD, UCSF – Tips for the PCORI Application Process
- Community-Engaged Research Guides and Resource Manuals Videos
- Michael Steinman, MD , UCSF - Resources to Support CER and Patient-Centered Outcomes Research
- Panel Discussion - Reflections of PCORI Grantees: What I Learned About Writing a Successful Application
- Dean Schillinger, MD, UCSF - The PCORI Review Process
- David Hickam, MD, MPH, PCORI – PCORI's Approach to Providing Support for Comparative Effectiveness Research
- UCSF Comparative Effectiveness Research Webinar: Getting Your PCORI Grant Funded: Advice from Insiders
- UCSF Comparative Effectiveness Research Symposium 2013: Priorities and Methods
- Michael Steinman, MD, UCSF - Comparative Effectiveness Research Program
- Michael Steinman, MD, UCSF - CER, PCOR, & the History of PCORI: Making Sense of Alphabet Soup
- Laura A. Schmidt, PhD, UCSF - An Introduction to Stakeholder-Engaged Research
- Staff, CTSI, UCSF - CTSI's Community Engagement and Health Policy Program (CEHP)
- Mike Potter, MD, UCSF - San Francisco Bay Area Collaborative Research Network (SF Bay CRN)
- Mike Potter, MD, UCSF - Stakeholder Engagement, Identifying the Right Stakeholders
- Kathryn A. Phillips, PhD, UCSF - What PCORI Wants
- Kathryn A. Phillips, PhD, UCSF - Health Services Research, Comparative Effectiveness Research, & Translational Science (T2) in the UCSF Helen Diller Family Comprehensive Cancer Center
- Tracy Lieu, MD, MPH, UCSF - Population-Based Networks for Comparative Effectiveness Research: Promises and Potholes
- Staff, UCSF - Philip R. Lee Institute for Health Policy Studies, Advisory Board Background Materials
- Diane D. Allen, Graduate Program, Physical Therapy, UCSF/SFSU - Mind the Gap—Targeting Differences in Patients' Current and Preferred Abilities
- Staff, UCSF - About Us - Improving health through policy, leadership, and research ....
- UCSF Comparative Effectiveness Research Symposium 2012: Policy and Resources
- Agenda (pdf 300KB) and partner institutions handout (pdf 3MB)
- Mark Hlatky, MD, Stanford University - Clinical Trials for Comparative Effectiveness Research (ppt 300KB)
- Steven Cummings, MD, San Francisco Coordinating Center - Direct to Participant Trials (ppt 500KB)
- Len Finocchio, DrPH, California Department of Health Care Services - An End-User Perspective on CER: View from the State (ppt 3MB)
- John Ioannidis, MD, DSc, Stanford University - Plenary Lecture: Comparative Effectiveness Research: Understanding and Designing the Geometry of the Research Agenda (ppt 9MB)
- Michael Steinman, MD, UCSF - Policy and Funding for CER: Making Sense of a Confusing Landscape (SlideShare)
- Charles McCulloch, PhD, UCSF - Analytic Methods and Issues in CER from Observational Data (SlideShare)
- Lisa Bero, PhD, UCSF - Case study: Methodology Reviews (SlideShare)
- UCSF Comparative Effectiveness Research Symposium 2011: Opportunities & Challenges
- Joe Selby: The "Promise" of Comparative Effectiveness Research (PDF 776KB)
- Robert Temple: Impact of Comparative Effectiveness on FDA (PDF 281KB)
- Charles McCullcoh: Newish Methods to Address Bias and Confounding in Observational Data (PDF 234KB)
- Mike Steinman's notes on June 2012 UCSF Conference Call on PCORI Funding Announcements (PDF 20KB)
- Clay Johnston's presentation Biomedical IT and Informatics: Where's the Revolution? for the 2010 Summit on Translational Bioinformatics (PDF 1.32MB)
- Neil Powe's presentation on CER for the American Association of Ophthalmology (PDF 334KB)
PCORI - what is it and what will it fund?
The Patient Centered Outcomes Research Institute (PCORI), a quasi-governmental organization, was created by Congress to support CER through grants and other funding opportunities. As of September 2011, it is just getting underway, and its priorities and funding procedures have yet to be announced. By 2014, it is expected to have an annual budget of $500 million and be the major source of funding for CER in the United States.
An overview of PCORI's legislative mandate and duties can be found here: Overview of the Patient-Centered Outcomes Research Institute.
Training and References
- Tufts offers an online survey course in CER
- AHRQ's Effective Health Care Program offers web-based CME programs on the comparative effectiveness of treatment strategies for different clinical conditions.
- Ohio State University offers a series of online courses on CER
- Archived Slide Sets and Videos
- Comparative Effectiveness Research: Background, Priorities, and Methods (Sean Tunis, Center for Medical Technology and Policy, Powerpoint, 2009)
- "Responding to the National CER Agenda: Evolving Data Sources and Analytics" (2010 symposium hosted by the Lewin Group with slides and speaker videos covering statistical, regulatory, policy, and other topics)
- White papers and seminal reports
- Federal Coordinating Council for Comparative Effectiveness Research Report to the President and the Congress (2009)
- Initial National Priorities for Comparative Effectiveness Research (Institute of Medicine, 2009)
- Other learning resources
- A brief primer and resources on pragmatic clinical trials (Center for Medical Technology Policy)
- Recommended reading
- From HSR Methods.org: Comparative Effectiveness
Resource guides and best practices
- PCORI Methodology Report (draft)
- PCORI Methodology Standards
- GRACE principles (best practices for the design, conduct, analysis, and reporting of observational CER studies).
- Methods guides for conducting comparative effectiveness assessments and reviews (AHRQ)
- A user's guide to registries to improve patient outcomes (AHRQ)
- Finding What Works in Health Care: Standards for Systematic Reviews (Institute of Medicine)
Conducting Pubmed searches for CER
- The National Library of Medicine has created search tools and other resources to support literature searches for CER.
Compendia of resources and programs:
- Effective Health Care Program (AHRQ's umbrella program for CER)
- CER resources from the National Cancer Institute
- CER resources from the National Library of Medicine
- CER resources from Academy Health
- CER resources from the Lewin Group
- CER resources from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Collaborations, research centers, and research networks:
- Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research: A forum to facilitate learning and collaboration across a set of CER projects designed to build infrastructure and methods for collecting and analyzing prospective electronic clinical data
- Centers for Education and Research on Therapeutics (CERTs)
- DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network
- Evidence Based Practice Centers
- Agency for Healthcare Research and Quality (AHRQ) Grants On-Line Database
- Multi-Payer Claims Database: A project under development to develop longitudinal claims data to support comparative effectiveness research
- Society of General Internal Medicine Research Dataset Compendium: Descriptions of and links to high-value publicly available research datasets
- Roadmap K12 Data Resource Center: Descriptions of and links to publicly available research datasets