Comparative Effectiveness Research (CER)

Cochrane Colloquium 2011Madrid, Spain

Kay Dickersin, MA, PhDOctober 22, 2011

Designing Sustainable Evidence-based Health Care in Times of Crisis

Orzag, CBO. 2007. Comparative Effectiveness Research

CER: Why now?

Medicare spending and quality of care

Baicker et al. Health Affairs web exclusives, October 7, 2004

December 2007

IOM (Institute of Medicine) Report: Knowing What Works in Healthcare.

A Roadmap for the Nation

Proposed a new entity with authority to produce systematic reviews of clinical effectiveness

• Set priorities, fund, manage systematic reviews

• Develop common language and standards

January 24, 2008

IOM recommendations (selected) 2008

Invest in advancing the scientific methods underlying the conduct of systematic reviews;

Assess the capacity of the research workforce to meet the Program’s needs.

o If deemed appropriate, expand training opportunities in systematic review and comparative effectiveness research methods.

A National Clinical Effectiveness Assessment Program should:

IOM Report: Initial National Priorities for CER

• Controlled trials• Observational studies

– Registry studies, large datasets– Cohort studies– Case control studies– Cross sectional studies– Case series

• Research synthesis– Systematic reviews and meta-

analysis– Technology assessment

June 30, 2009

Methods commonly used in CER

"The whole point of this is to try to encourage what works.”

“And part of what we want to do is to make sure that those decisions are being made by doctors and medical experts based on evidence, based on what works, because that's not how it's working right now.”

President Barack Obama July 22, 2009

PL 111-148 The Patient Protection & Affordable Care Act

March 23, 2010

The Patient Protection & Affordable Care Act 2010

Established a non-profit Patient Centered Outcomes ‐Research Institute (PCORI) to conduct CER:

• Identify national priorities for research• Appoint Board of Governors

– AHRQ and NIH, 3 patients/consumers, 5 providers, 3 payers, 3 industry, 1 representing quality improvement or independent health services researcher, 2 representing federal or state interests.

• Establish Methodology Committee to set standards for CER• Perform patient-centered CER

Mandated two IOM studies:Standards for conducting SRsStandards for trustworthy CPGs

Medicare Improvement for Patients and Providers Act of 2008

Reports of the two committees released March 22, 2011

Federally-supported initiatives related to systematic reviews

Internal programs - agency or contractual investigators:

AHRQ - EPCs (evidence-based practice centers) (n=14)CDC - Guide to Community Preventive ServicesCDC - HIV/AIDS Prevention Research SynthesisDept. Health & Human Services/SAMHSA - mental health and substance abuse disordersDept. Education - What Works ClearinghouseDept. Justice – Model Programs Guide

Federally-supported initiatives related to systematic reviews

External programs: NICHD – Cochrane Neonatal Review

GroupNEI – Cochrane Eyes and Vision GroupNCCAM – Cochrane Complementary and

Alternative Medicine Field

• Learn from other countries • Provide support for:

– A coordinated approach– Infrastructure funds to external organizations– Methods research for clinical trials and systematic reviews– Infrastructure for investigator- initiated & commissioned

systematic reviews• Ensure that mechanisms for CER support are sustained• Require a systematic review before funding a trial

Source: Science 329:516; 2010

http://www.pcori.org/

http://www.pcori.org/

PCORI Pilot Projects (Due Dec 1 2011)

• Inform the national comparative effective research priorities;

• Bring together different stakeholders; • Translate research into practice; • Identify gaps in relation to issues for

disadvantaged populations; and • Identify predictors of patient outcomes

PCORI Pilot Projects (Due Dec 1 2011)

– Identify choices within patient control that may influence outcomes.

– Better understand patient-clinician interactions

– Assess strategies promoting patient autonomy & informed decision-making.

A future for Cochrane reviews & infrastructure Under the US-CER banner?

• Depends on how Cochrane needs match up with PCORI’s goals

• Depends on PCORI decision to support internal vs external systematic reviews

• Is Cochrane adaptable? March to its own drummer vs workable partnerships.

• Right now, we have chosen to be cautiously optimistic………….