Seminars & Workshops
1. Comparative Effectiveness Research: Recent History and Role in Healthcare Reform; Rationale for CER

After completing this lecture, you will be able to:

  • Define CER based on standard definitions and the typical activities that it encompasses
  • Review the motivations, accomplishments, and impediments for CER
  • Describe how CER is supported in the United States now and how the new Patient-Centered Outcomes Research Institute will support CER
  • Identify the roles for CTSAs in facilitating and implementing CER
  • Discuss specific needs, next steps, and the future of CER
  • Identify the forces shaping national priorities for CER in the United States
  • Explain the current CER landscape in the United States
  • Compare and contrast comparative effectiveness and cost-effectiveness research.

Taught by: Harry P. Selker, MD, MSPH and Peter J. Neumann, ScD.

Seminars & Workshops
10. Clinical Practice Guidelines

After completing this lecture, you will be able to:

  • Explain the rationale for clinical practice guidelines
  • Discuss the process of clinical practice guideline development: (a) evidence synthesis and appraisal; (b) grading of evidence and recommendations
  • Identify challenges in making clinical practice guidelines more trustworthy: (a) applying transparent judgments when moving from systematic reviews to recommendations; (b) containing conflicts of interest in guideline development committees; and (c) making guidelines applicable to persons with more than one disease.

Taught by: Katrin Uhlig, MD, MS.

Seminars & Workshops
11. Clinical Effectiveness Trials and Predictive Instruments as Decision Support for Implementing CER

After completing this lecture, you will be able to:

  • Discuss the use of comparative effectiveness trials for comparing strategies of care
  • Explain the use of predictive instruments as decision support for evidence-based clinical care and their evaluation by clinical trials
  • Review how predictive instruments are incorporated into the use of medications and other treatments
  • Discuss the possible use of predictive instruments for efficient and ethical conduct of clinical effectiveness trials.

Taught by: Harry P. Selker, MD, MSPH.

Seminars & Workshops
12. Drug Development in the CER Era

After completing this lecture, you will be able to:

  • Assess the economic, regulatory, and political pressures affecting pharmaceutical and biopharmaceutical developers today
  • Discuss current drug development metrics, including the time, cost, and risk of development
  • Examine how companies, in response to competitive and economic pressures, are adopting new strategies and practices to improve R&D performance.

Taught by: Kenneth I. Kaitin, PhD.

Seminars & Workshops
13. Using Comparative Effectiveness Research to Reach Employers and Employees

After completing this lecture, you will be able to:

  • Identify current and projected health, healthcare, and cost issues facing employers and employees
  • List workplace policies, practices, and programs that are being used to address health and cost trends
  • Describe the evidence base for workplace health programs in wellness, occupational health, and benefits design
  • Identify methodological problems and solutions to developing the evidence base and the role of comparative effectiveness studies in generating required evidence
  • Identify issues related to the dissemination and implementation of evidence from comparative effectiveness studies.

Taught by: Debra Lerner, MS, PhD

Seminars & Workshops
14. Economic and Policy Implications of CER

After completing this lecture, you will be able to:

  • Discuss how performance assessment and financial incentive models have been used to impact transformational changes in healthcare policy
  • Using specific examples, explain how comparative effectiveness research and outcomes measurement impact value-priced purchasing and the cost of healthcare delivery
  • Describe how a multidimensional framework for measuring outcomes of care and efficiency assists policymakers to make informed decisions that improve health care
  • Discuss opportunities and roles for use of insurance data to improve health care
  • Identify the differences between chart-based clinical process-of-care measures versus clinical outcomes measurement and comparative effectiveness research in healthcare delivery systems.

Taught by: Christopher P. Tompkins, PhD.

Seminars & Workshops
15. IOM 100 Priorities & AHRQ 14 Priority Conditions and Populations; the USPSTF Breast Cancer Screening Guidelines; CER: A Panel Discussion

After completing this lecture, you will be able to:

  • Describe the priority-setting processes for CER-related funds, as established by the Affordable Care Act
  • Identify IOM priorities related to their individual research interests
  • Distinguish CER studies aimed at comparison of clinical interventions from those that compare effective healthcare strategies, or both clinical interventions and healthcare strategies.

Taught by: Thomas W. Concannon, PhDHarry P. Selker, MD, MSPH, and a Faculty Panel.

Seminars & Workshops
2. Introduction: A Review of Evidence-Based Medicine (EBM) and a Framework for Understanding the CER Agenda

After completing this lecture, you will be able to:

  • List the principles of Evidence-Based Medicine (EBM)
  • State how CER extends the principles of EBM
  • Describe a framework for understanding the CER agenda
  • Identify the stakeholders of CER.

Taught by: Thomas W. Concannon, PhD.

Seminars & Workshops
3. Comparative Effectiveness Trials; Assessing Pharmacogenetic Information in Clinical Trials

After completing this lecture, you will be able to:

  • Identify the need for comparative effectiveness trials, even for drug therapies where “proof of efficacy” is already required prior to approval
  • Explain the differences between pragmatic/effectiveness trials and explanatory/efficacy trials
  • List the strengths and limitations of pragmatic versus explanatory designs
  • State the strengths and limitations of various types of outcome measures, including surrogate versus clinical outcomes
  • Explain the difference between prognostic and predictive genetic markers
  • Identify the pros and cons of alternative research designs for assessing pharmacogenetic (predictive) effects
  • Discuss “repurposed” randomized trials for assessing pharmacogenetic effects
  • Define empirical data.

Taught by: David M. Kent, MD, MSc and Thomas A. Trikalinos, MD, PhD.

Seminars & Workshops
4. Personalized Medicine, Heterogeneity of Treatment Effect, and Implications for Comparative Effectiveness

After completing this lecture, you will be able to:

  • Identify the limitations of applying the overall results of clinical trials to individual patients
  • Discuss how summary results of individual trials might not even reflect the benefits of typical patients in the trial
  • Explain how subgroup analyses are prone both to false-positive and false-negative results
  • Illustrate approaches that might lead to more credible and actionable subgroup results
  • Express why multidimensional risk models may have advantages over conventional “one-variable-at-a-time” subgroup analysis
  • Determine some of the limitations of using genetic information as a basis for exploring heterogeneity of treatment effect.

Taught by: David M. Kent, MD, MSc.

Seminars & Workshops
5. Retrospective and Observational Comparative Effectiveness Studies

After completing this lecture, you will be able to:

  • State the limitations of randomized controlled trials
  • Identify the settings in which observational studies of comparative effectiveness may be particularly helpful to clinicians and policymakers
  • Explain the methodological challenges in conducting retrospective, observational CER using existing sources of data
  • Describe model-based and other approaches to reduce the effects of confounding in observational CER
  • Discuss specific examples of retrospective and observational CER, and how these have informed public policy and healthcare delivery system change
  • List key aspects and the steps of a systematic review
  • Identify the methodological and inferential challenges of longitudinal observational studies of health outcomes and delivery system change.

Taught by: Dana Gelb Safran, ScD and Peter K. Lindenauer MD, MSc.

Seminars & Workshops
6. Systematic Review and Meta-Analysis

After completing this lecture, you will be able to:

  • List the reasons for conducting systematic reviews
  • Appreciate the role of systematic review in CER
  • Describe the components of a systematic review
  • State the role of analytic frameworks in systematic review and the approach to formulate answerable systematic review questions
  • Identify the users and producers of systematic reviews
  • Define the basic principles of combining data
  • Identify the common metrics for meta-analysis
  • List the basics of combining results across studies and effects of weights
  • Explain the meaning of heterogeneity
  • Discuss the fixed effect and random effects model
  • Interpret meta-analysis results.

Taught by: Joseph Lau, MD and Christopher H. Schmid, PhD.

Seminars & Workshops
7. Decision Modeling – Cost-Effectiveness

After completing this lecture, you will be able to:

  • Show how the probability of a diagnosis is affected by a test result, sensitivity, and specificity
  • Describe how evidence can be integrated using decision trees
  • Illustrate the concept of threshold probabilities and their implications
  • Discuss how sensitivity analyses are performed and what they mean
  • Explain how patient preferences (utilities or values) can be integrated into patient-centered choices using decision analysis
  • Identify different types of economic analyses in comparative effectiveness research
  • Explain how to calculate incremental cost-effectiveness
  • List how cost-effectiveness analysis is being used for technology assessment

Taught by Stephen G. Pauker, MD and John B. Wong, MD.

Seminars & Workshops
8. Decision Modeling – Simulations

After completing this lecture, you will be able to:

  • Explain the principles underlying the use of Markov models, including (a) how to compute the distribution of a cohort among population states given a starting distribution and a set of transition probabilities; (b) how a model can be used to compute incurred costs and accrued quality-adjusted life years over time; and (c) Markov model limitations and how they can be addressed by more complex Markov model designs
  • Discuss how simulation models can be used to characterize uncertainty attending model assumptions, including use of nonprobabilistic sensitivity analysis and probabilistic uncertainty analysis
  • Define decision-making contextual factors that make the resolution of uncertainty either more or less valuable.

Taught by: Joshua T. Cohen, PhD.

Seminars & Workshops
9. Community Engagement and Input into CER

After completing this lecture, you will be able to:

  • Define “community” and “community engagement”
  • Delineate key points where community engagement may enhance comparative effectiveness research
  • Identify examples of research strategies and methodologies employed to engage communities.

Taught by: Laurel K. Leslie, MD, MPH.