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So You Want to Do Comparative Effectiveness Research?. The Nuts and Bolts of CER. Introduction to Comparative Effectiveness Research. Greg Cooper, MD. CER - ACA Definition.

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So You Want to Do Comparative Effectiveness Research?

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So you want to do comparative effectiveness research

So You Want to Do Comparative Effectiveness Research?

The Nuts and Bolts of CER

Introduction to comparative effectiveness research

Introduction to Comparative Effectiveness Research

Greg Cooper, MD

Cer aca definition

CER - ACA Definition

  • Research evaluating and comparing health outcomes and the clinical effectiveness, risks and benefits of 2 or more medical treatments, services and items

Categories of cer methods

Categories of CER Methods

  • Systematic reviews of existing research

  • Decision modeling, with or without cost information

  • Retrospective analysis of existing clinical or administrative data

  • Prospective, non-experimental studies, including registries

  • Experimental studies, including RCT’s

Pragmatic clinical trials

Pragmatic Clinical Trials

  • Compared to explanatory

  • Decision maker viewpoint – should we provide intervention?

  • Whether an intervention works in “real world” conditions

  • Whether it works, not how or why

Pragmatic clinical trials1

Pragmatic Clinical Trials

  • Patient selection reflects routine practice

    • Exclude only if contraindicated

  • Intervention to discretion of clinician

    • Dose adjustment

  • Control routine practice (vs. placebo)

  • Patient centered outcomes

  • Always ITT analysis

Pragmatic clinical trials2

Pragmatic Clinical Trials

  • Identify prevalent condition

    • Often based on symptoms rather than explicit, verifiable diagnoses

  • Evaluate common clinical dilemma in that condition

  • Develop pragmatic study to understand health outcomes between competing management approaches

Primary care management of gerd

Primary Care Management of GERD

Open label study of patients with symptomatic GERD despite H2RA or omeprazole

Randomization at clinic level (n=226)

Screened on basis of 5 item questionnaire

Intervention esomeprazole at dose selected by clinician (20 or 40 mg) or continued care

Measured HRQOL and utilities at 4 weeks

Moayeddi, et al: Am J Gastroenterol 2010



Patient centered outcomes research institute

Patient Centered Outcomes Research Institute

Pcori research areas

PCORI Research Areas

  • Prevention, Diagnosis and Treatment Options

  • Improving Healthcare Systems

  • Communication and Dissemination Research

  • Addressing Disparities

  • Accelerating Patient-Centered Outcomes Research and Methodological Research

Pcori funding

PCORI Funding

  • Up to 3 years, $500K/year (direct costs)

    • 8/15, 12/15, 4/15 deadlines

  • Letter of Intent Required (2 months prior)

  • Must have key stakeholders engaged early and throughout research process

  • Patient and stakeholder engagement plan

    • Involved in study design and monitoring conduct

    • Involved in dissemination of findings



  • Patients

  • Caregivers

  • Clinicians

  • Patient advocacy groups

  • Community groups

  • Involved in advisory panels, teleconferences, focus groups

Cer and the ctsa

CER and the CTSA

Develop a CTSA Consortium-wide framework for community-engaged and CER that will support improvement in healthcare access, quality, efficiency and patient-centered outcomes and will improve the health of diverse communities and the public

CER Key Function Committee (KFC)

Cer and case ctsc

CER and Case CTSC

  • Pilot projects 2010

  • Core Utilization Pilots

  • Explorys Pilots

  • Research symposium 2010

  • Three focal areas

    • Large database

    • Economic analysis

    • EHR

Cer services

CER Services

  • Assistance with study design

    • Pilots

    • Investigator initiated projects

  • Grant preparation

  • Facilitating referrals

  • Through Request Management System (RMS)

Symposium objectives

Symposium Objectives

  • Overview of CER Methodology

    • Electronic Health Records

    • Large Database Research

    • Systematic Review/Meta Analysis

  • Practical Examples

  • Panel Discussion

  • Encourage Core Utilization

  • Ideas for future talks, symposia

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