ISE 599 Comparative Effectiveness Researchin Health Systems

Fall 2009

Tuesday & Thursday 2:00 to 3:20 PM

Room ZHS 360

General information:The course meets every Tuesday andThursday from 2:00~3:20 PM in ZHS 360

Instructor: Dr. Shinyi Wu, Assistant Professor, ISE

Tel: (213)740-5073; Email: ; GER 240c

Office hour: Thursday from 3:30 to 4:30 PMor by appointment

Grading: 3Units,Letter grades

Learning Objectives:

This course introduces methods ofcomparative effectiveness research in health systems pertaining to improve quality and affordability. The first half of the course will be devoted to quality improvement and assessment research methods and the second half to cost-effectiveness analysis. Students will learn the theoretical framework, methodological approaches, and contemporary development of quality of care research and cost-effectiveness analysis to address critical health care problems. Students should leave this class with intellectual understanding of the challenges and opportunities to conduct scientific quality improvement and economic assessment in healthcare.They should also gain proficiency in constructing an appropriate research design to improving and assessing healthcare quality, valuing health outcomes, and conducting cost-effectiveness and cost-utility analyses when evaluating a broad spectrum of medical practices and technologies.

Prerequisites:

ISE 426 Statistical Quality Control (or equivalent) and ISE 460 Engineering Economy (or equivalent).

Required Textbooks:

  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003
  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach(2nd ed.).San Francisco, CA: Jossey-Bass, 2008.

For Reference:

  • Aday LA, Begley CE, Lairson DR, Slater CH. Evaluating the Medical Care System: Effectiveness, Efficiency, and Equity. Ann Arbor, MI: Health Administration Press, 1993
  • Berwick DM, Godfrey AB, Roessner J. Curing Health Care: New Strategies for Quality Improvement (Paperback). San Francisco, CA: Jossey-Bass, 2002.
  • KovnerAR, and Knickman JR. (editors).Jonas & Kovner’s Health Care Delivery in the United States (9th ed.). New York: Springer Publishing Co., 2008.
  • Hurtado MP, Swift EK, Corrigan JM (editors).Crossing the Quality Chasm: A New Health System for the 21st Century.Washington, D.C.: NationalAcademy Press, 2001.
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, OxfordUniv. Press, 1996.
  • Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes, (3rd ed). New York, NY: OxfordUniversity Press, 2005.
  • Hunink M and GlasziouP.Decision Making in Health and Medicine, New York: CambridgeUniversity Press, 2001.

Optional

  • TreeAge Pro Suite Student Version software for decision/cost-effectiveness analysis (This program is available in the student computer lab. Also available from Treeage, Inc., web site: (You can download the student version directly for $xx, which entitles you to a 12-month license.

Students are expected to read all assigned material before the class session in which it will be discussed. Readings supplementing the texts will be distributed in class or made available in electronic copy.No further distribution or circulation of the reading materials is permitted.

Evaluation Criteria:

Students will be given two assignments: one involving quality improvement research, and the otherinvolving cost-effectiveness analysis.There will a final paper applying the methodslearned in this class to a problem of interest selected by the student. In addition, each student will be given another student’s term paper for critique. Final grades will be calculated as follows:

Quality research assignment15% (due 10/6)

Cost-effectiveness analysis assignment 15% (due 11/17)

Term paper critique 15% (due 12/3)

Term paper presentation20% (due 12/1 or 12/3)

Final term paper25% (due 12/12)

Classroom participation:10%

Please put your name on the material you submit.

Paper Instructions

Students will be required to individually write a 15±3 page paper of a quality improvement assessment or cost-effectiveness analysis. It is best to start thinking about the paper as early in the course as possible. To assist in moving your ideas forward you will be required to write a 1-page overview of your project (due on November3) and to give a presentation (December1 or 3) including your results as well as their public, clinical, or operational policy implications. You should not consider this "final" presentation completely "final" as many students find the feedback from other students and faculty helpful in furthering their ideas. Indeed, each student is required to turn in a structured, constructive one-page critique of another student’s paperin class on 12/3 to be shared with the author. The assignment of paper will be a random draw. A final written version of your paper is due on December12.

You have four options in writing a paper:

1.Quality improvement assessment project.This option is suitable for students who have access to an existing quality improvement project and have permission to collect data or have access to primary data from the project.

2.Cost-effectiveness analysisproject using decision analysis and TreeAge or other software. This option can be a primary or secondary data analyses or modeling. You may analyze the primary data available to you or use publicly available secondary data or the literature to develop and analyze its costs and effects data.

3.Systematic review of previously published relevant studies for comparative-effectiveness research purpose. In order to pursue this option, there must be at least 5 previously published studies addressing the quality and/or cost-effectiveness of a defined clinical question. For students considering this option, they need to discuss with the course instructor for approval and further direction.

4.Other relevant research related issues (e.g., methods of quality measurement, costing, defining perspective in an analysis). For students considering this option, they need to discuss with the course instructor for approval and further direction.

Statement on Academic Integrity

USC seeks to maintain an optimal learning environment. General principles of academic honestyinclude the concept of respect for the intellectual property of others, the expectation thatindividual work will be submitted unless otherwise allowed by an instructor, and the obligationsboth to protect one’s own academic work from misuse by others as well as to avoid usinganother’s work as one’s own. All students are expected to understand and abide by theseprinciples. Scampus, the Student Guidebook, contains the Student Conduct Code in Section11.00, while the recommended sanctions are located in Appendix A: Students will be referred to the Office of Student Judicial Affairs and Community Standards forfurther review, should there be any suspicion of academic dishonesty. The Review process canbe found at:

Statement for Students with Disabilities

Any student requesting academic accommodations based on a disability is required to registerwith Disability Services and Programs (DSP) each semester. A letter of verification for approvedaccommodations can be obtained from DSP. Please be sure the letter is delivered to me (or toTA) as early in the semester as possible. DSP is located in STU 301 and is open 8:30 a.m.–5:00p.m., Monday through Friday. The phone number for DSP is (213) 740-0776.

The session dates, topics and readings are provisional and subjective to change.

Session

/ Date / Topic and Readings
1 / 8/25 / The U.S. Healthcare System Objectives and Performance
2 / 8/27 / Overview of Comparative Effectiveness Research
Readings: 1) Brookings CER report; 2) Brook, 2009
3 / 9/1 / Foundations of Quality Improvement and Management
Readings: 1)Berwick Chapter 1, 2, 3. 2) Spear & Bowen, 1999.
4 / 9/3 / The Components of Quality in Healthcare Delivery
Readings: 1) Donabedian Introduction and Chapter 1.
2) HurtadoExecutive summary.
5 / 9/8 / Challenges in Improving Health Care Quality
Readings: 1) Ovretveit, 2002. 2) Kovner Chapter 15.
6 / 9/10 / Identifying the Root Causes
Reading: 1) Spear 2005. 2) Porter & Teisberg, 2004. 3) Mittman 2004.4) Rubenstein, 2008
7 / 9/15 / Guest speaker: Marjorie Pearson, PhD, RAND Corporation
Assessing Implementation of Healthcare Quality Improvement
8 / 9/17 / Guest speaker: Geoffrey Joyce, PhD, USC Pharmacy School
Introduction to Health Economics
9 / 9/22 / Using the Scientific Method to Define Problems
Readings: 1) Berwick Chapter 4. 2) Shi Chapter 1, 1997
10 / 9/24 / Improving Healthcare Quality
Readings: 1) Berwick Chapter 9, Afterward, and Preface to the Paperback Edition. 2) AHRQ Quality Fact Sheets. 3) Cretin 2003
11 / 9/29 / A Model for System Performance Assessment
Readings: 1) Donabedian 1966. 2) Donabedian Chapters2,3,4. 3) Pearson et al., 2005.
12 / 10/1 / Formulating Criteria and Standards
Readings: 1) Donabedian Chapter 5. 2) Aday Chapter 2,3.
13 / 10/6 / Obtaining the Necessary Information
Readings: 1) Donabedian Chapters 6,7,8, and appendices. 2) Shi Chapter 3.
14 / 10/8 / Critiques of The Science of Quality Improvement
Readings: 1) Davidoff & Batalden 2005. 2) Auerbach 2007. 3) Batalden & Davidoff, 2007. 4) Berwick 2008. 5) Donabedian Chapter 9, 10.
(Assignment #1 due)
15 / 10/13 / Discussion of Assignment #1
16 / 10/15 / Introduction to Cost-Effectiveness Research
Readings: 1) Aday Chapter 4. 2) Muennig Chap 1; 3) Gold Chap 1. 4) Neumann & Sullivan, 2006; 5) Weinstein & Stason, 1977
17 / 10/20 / Research Design Issues
Readings: 1) Muennig Chap 2,4. 2) Gold Chap 3. 3) Ramsey et al., 2001.
18 / 10/22 /

Measuring Health Outcomes

Readings: 1) Patrick & Bergner, 1990. 2) Ware & Sherbourne., 1992. 3) Fryback, 1998. 4) McHorney & Fleishman, 2006.
19 / 10/27 /

Valuing Health Outcomes

Readings: 1) Hunink Chap 4. 2) Muennig Chap 8 (and pp. 132-133). 3) Gold Chap 4.

20 / 10/29 /

Measuring and Valuing Costs

Readings: 1) Muennig Chapter 4.2) Gold Chapter 6. 3) Finkler, 1982. 4) Hirth et al., 2000. 5) Brown et al., 2007
21 / 11/3 / Estimating Probabilities and Utilities
Readings: 1) Muennig Chapter5,8.2) Gold Chapter 5.
22 / 11/5 / Incremental Cost –Effectiveness analysis I: Resource Allocation.
Readings: 1)Hunink Chapter 9 p 277-304. 2) Doubilet, 1986. 3) Weinstein, 1995. 4) Cohen et al., 2004. 5) Cohen et al., 2005.
23 / 11/10 /

(Tentative)Guest Speaker: Emmett Keeler, PhD, RANDIncremental Cost-Effectiveness Analysis II: Competing Choice Problem, Strong & Weak Dominance

Readings: 1) Weinstein MC et al. “Recommendations of the Panel.” JAMA 1996; 276:1253-1258 and 1339-1341. 2) Brouwer & Rutten, 2003. 3) Lavigne & Sorbero, 2005.
24 / 11/12 /

Time Preference and Discounting

Readings: 1) Gold Chapter 7; 2) Redelmeier DA et al. “Time preference in Medical Economics: Science or Religion?” Med Decis Making 1994; 14:310-313. 3) Ubel, 2003.
25 / 11/17 / More on ICERs, Handling Uncertainty & Sensitivity Analysis
Readings: 1) Gold Chapter 8. 2) Muennig Chapter 9.
(Assignment #2 due)
26 / 11/19 / Discussion of Assignment #2
27 / 11/24 / In class office hours for working with aspects of term paper.
Readings: 1)Chiou, 2003. 2) Wang, 2001. 3) Shepard, 1986. 4) Huang, 2007.
28 / 11/26 /

No Class/Thanksgiving

29 / 12/1 / Student presentations. Draft term paper due in class for critique by classmate (please bring two copies).
30 / 12/3 / Student presentations. 1 page term paper critique due.
Final term paper due 12/12 noon.

Reading List:

Session 2.

  • Brookings Report 9The Hamilton Project). Implementing Comparative Effectiveness Research: Priorities, Methods, and Impact. June 2009.
  • Brook RH. Possible Outcomes of Comparative Effectiveness Research. JAMA. 2009;302(2):194-195

Session 3.

  • Berwick DM, Godfrey AB, Roessner J. Curing Health Care: New Strategies for Quality Improvement (Paperback). San Francisco, CA: Jossey-Bass, 2002.
  • Chapter 1, Symptoms of Stress in the Health Care System
  • Chapter 2, Applying Quality Management to Health Care
  • Chapter 3, Foundations of Quality Improvement.
  • Spear SJ, Bowen HK. Decoding the DNA of the Toyota Production System. Harvard Business Review, 1999.

Session 4.

  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003.
  • Introduction
  • Chapter 1, The Components of Quality in Health Care
  • Hurtado MP, Swift EK, Corrigan JM (editors). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: NationalAcademy Press, 2001.
  • Executive summary

Session 5.

  • Ovretveit J, Bate P, Cleary P et al., Quality collaboratives; lessons from research. Quality and Safety in Health Care2002; 11:345-351
  • KovnerAR, and Knickman JR. (editors). Jonas & Kovner’s Health Care Delivery in the United States (9th ed.). New York: Springer Publishing Co., 2008.
  • Chapter 15, The Complexity of Health Care Quality, by Douglas S. Wakefield and Bonnie J. Wakefield

Session 6.

  • Spear SJ. Fixing Health Care from the Inside, Today. Harvard Business Review, 2005.
  • Porter ME, Teisberg EO. Redefining Competition in Health Care. Harvard Business Review, 2004.
  • Mittman BS. Creating the evidence base for quality improvement collaboratives. Annals of Internal Medicine, 2004; 140:897-901.
  • Rubenstein LV, Hempel S, Farmer MM et al., Finding order in heterogeneity: types of quality-improvement intervention publications. Quality and Safety in Health Care, 2008; 17; 403-408

Session 9.

  • Berwick DM, Godfrey AB, Roessner J. Curing Health Care: New Strategies for Quality Improvement (Paperback). San Francisco, CA: Jossey-Bass, 2002.
  • Chapter 4, Using the Scientific Method to Define Problems
  • Shi L. Health Services Research Methods. Albany, NY: Delmar Publishers, Inc., 1997.
  • Chapter 1, Scientific Foundations of Health Services Research

Session 10.

  • Berwick DM, Godfrey AB, Roessner J. Curing Health Care: New Strategies for Quality Improvement (Paperback). San Francisco, CA: Jossey-Bass, 2002.
  • Chapter 9, Ten Key Lesson for Quality Improvement
  • Afterword: Reflection on the Future
  • Preface to the Paperback Edition: Ten Things We Know Now That We Wish We Had Known Then
  • Agency for Healthcare Research and Quality (AHRQ) Fact Sheets:
  • Improving Health Care Quality, AHRQ Pub. No. 02-P032, September 2002
  • Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies, AHRQ Pub. No. 04-P014, March 2004
  • Cretin S, Shortell SM, Keeler EB. An Evaluation of Collaborative Interventions To Improve Chronic Illness Care: Framework and Study Design. Evaluation Review, 2003.

Session 11.

  • Donabedian A. Evaluating the Quality of Medical Care. Milbank Quarterly, Vol. 83(4): 691-729, 2005 (Reprinted from the Milbank Memorial Fund Quarterly, Vol 44(3, Pt.2): 166-203, 1966)
  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003.
  • Chapter 2, Determining What to Monitor
  • Chapter 3, Determining Priorities in monitoring
  • Chapter 4, Selecting Approaches to Assessing Performance
  • Pearson ML, Wu S, Schaefer J, Bonomi AE, Shortell SM, Mendel PJ, Marsteller JA, Louis TA, Keeler EB. Assessing the Implementation of the Chronic Care Model in Quality Improvement Collaboratives, Health Services Research, 40(4): 978-996, 2005.

Session 12.

  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003.
  • Chapter 5, Formulating Criteria and Standards
  • Aday LA, Begley CE, Lairson DR, Slater CH. Evaluating the Medical Care System: Effectiveness, Efficiency, and Equity. Ann Arbor, MI: Health Administration Press, 1993
  • Chapter 2, Effectiveness: Concepts and Methods
  • Chapter 3, Effectiveness: Evidence and an Application

Session 13.

  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003.
  • Chapter 6, Obtaining the Necessary Information
  • Chapter 7, Choosing When and How to Monitor
  • Chapter 8, Constructing a Monitoring System
  • Appendices
  • Shi L. Health Services Research Methods. Albany, NY: Delmar Publishers, Inc., 1997.
  • Chapter 3, Groundwork in Health Services Research

Session 14.

  • Davidoff F, Batalden P. Toward Stronger Evidence on Quality Improvement. Draft Publication Guidelines: The Beginning of a Consensus Project. Quality and Safety in Health Care, 14:319-325, 2005.
  • Auerbach AD, LandefeldSC, Shojania KG. The Tension between Needing to Improve Care Knowing How to Do It. The New England Journal of Medicine, 375(6): 608-13, 2007
  • Batalden P, Davidoff F. What is “Quality Improvement” and How Can It Transform Healthcare? Quality and Safety in Health Care, 16:2-3, 2007.
  • Berwick DM. The Science of Improvement. JAMA, 299 (10): 1182-4, 2008
  • Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: OxfordUniversity Press, 2003.
  • Chapter 9, Bringing About Behavior Change
  • Chapter 10, The Effectiveness of Quality Monitoring

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Session 16.

  • Aday LA, Begley CE, Lairson DR, Slater CH. Evaluating the Medical Care System: Effectiveness, Efficiency, and Equity. Ann Arbor, MI: Health Administration Press, 1993
  • Chapter 4, Efficacy: Concepts and Methods
  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach (2nd ed.).San Francisco, CA: Jossey-Bass, 2008.
  • Chapter 1, Introduction to Cost-Effectiveness
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, Oxford Univ. Press, 1996.
  • Chapter 1, Cost-Effectiveness analysis as a Guide to Resource Allocation in Health: Roles and Limitations
  • Neumann PJ, SD Sullivan. Economic Evaluation in the US: What is the Missing Link? Pharmacoeconomics, 24(11):1163:68, 2006.
  • Weinstein MC, Stason WB. Foundations of Cost-effectiveness Analysis for Health and Medicine. N Engl J Med, 296:716-721, 1977.

Session 17.

  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach (2nd ed.).San Francisco, CA: Jossey-Bass, 2008.
  • Chapter 2, Developing a Research Project
  • Chapter 4, Finding the Data You Need
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, Oxford Univ. Press, 1996.
  • Chapter 3, Framing and Designing the Cost-Effectiveness Analysis
  • RamseySD, McIntosh M, and Sullivan SD. Design Issues for Conducting Cost-effectiveness Analyses alongside Clinical Trials. Annu Rev Public Health, 22:129-41, 2001.

Session 18.

  • Patrick DL, Bergner M. Measurement of Health Status in the 1990s. Annu Rev Public Health, 11:165-83, 1990
  • Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual Framework and Item Selection. Medical Care, 30(6), 473-483, 1992
  • Fryback DG. Appendix C: Methodological Issues in Measuring Health Status and Health-Related Quality of Life for Population Health Measures: A Brief Overview of the “HALY” Family of Measures. In: Field MJ, Gold MR (ed). Summarizing Population Health: Directions for the Development and Application of Population Metrics, Washington, D.C.: NationalAcademy Press, 1998
  • McHorney CA, Fleishman JA. Assessing and Understanding Measurement Equivalence in Health Outcome Measures. Medical Care, 44(Suppl 3): S205-S210, 2006

Session 19.

  • Hunink M and Glasziou P. Decision making in Health and Medicine, New York: Cambridge University Press, 2001.
  • Chapter 4, Valuing Outcomes
  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach (2nd ed.).San Francisco, CA: Jossey-Bass, 2008.
  • Chapter 8, Working with Quality of Life Measures
  • Chapter 9, Calculating Quality-Adjusted Life Years
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, Oxford Univ. Press, 1996.
  • Chapter 4, Identifying and Valuing Outcomes

Session 20.

  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach (2nd ed.).San Francisco, CA: Jossey-Bass, 2008.
  • Chapter 4, Working with costs
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, Oxford Univ. Press, 1996.
  • Chapter 6, Estimating Costs in Cost-effectiveness Analysis
  • Finkler SA. The distinction Between Cost and Charges, Annuals of Internal Medicine, 1982; 96:102-109
  • Hirth RA, Chernew ME, Miller E, Fendrick AM, Weissert WG. Willingness to Pay for a Quality-adjusted life Year: In Serach of a Standard. Medical Decision Making, 2000;20:332-342
  • Brown SE, Chin MH, Huang ES. Estimating costs of quality improvement for outpatient healthcare organizations: a practical methodology. Quality and Safety in Health Care, 2007; 16:248-251

Session 21.

  • Muennig P. Cost-Effectiveness Analyses in Health: A Practical Approach (2nd ed.).San Francisco, CA: Jossey-Bass, 2008.
  • Chapter 5, Probabilities and Models
  • Chapter 8, Calculating QALYs
  • Gold MR, Siegel JE, Russell LB, Weinstein MC. (eds.), Cost-Effectiveness in Health and Medicine, Oxford Univ. Press, 1996.
  • Chapter 5, Assessing the Effectiveness of Health Interventions

Session 22.

  • Hunink M and Glasziou P. Decision Making in Health and Medicine, New York: CambridgeUniversity Press, 2001.
  • Chapter 9, Constrained resources (p. 277-304)
  • Doubilet P, Weinstein MC, McNeil BJ. Use and Misuse of the Term “Cost Effectiveness” in Medicine, the New England Journal of Medicine, 1986; 312:4, p. 253-255
  • Weinstein MC. From Cost-Effectiveness Ratios to Resource Allocation: Where to Draw the Line? In Sloan FA, ed. Valuing Health Care: Costs, Benefits, and Effectiveness of Pharmaceuticals and Other Medical Technologies. New York: CambridgeUniversity Press, 1995:77-98.
  • Cohen DA, Wu S, Farley TA. Comparing the cost-effectiveness of HIV prevention interventions. J Acquir Immune Defic Syndr 2004; 37:1404-1414
  • Cohen DA, Wu S, Farley TA. Cost-effective allocation of government funds to prevent HIV infection. Health Affairs 2005; 24(4): 915-926

Session 23.

  • Weinstein MC et al. “Recommendations of the Panel.” JAMA 1996; 276:1253-1258 and 1339-1341.
  • Brouwer WBF, Rutten FFH. The missing link: on the line between C and E. Health Economics 2003; 12: 629-636
  • Lavigne JE; Sorbero MS. "Productivity measurement in cost effectiveness analysis: Empirical test of a measurement controversy". Medical Decision Making, 2005; 25.

Session 24.