Today ’ s Objectives: Data Type, Quality & Source

1. Health and Cost Data InputsAdvanced Training in Clinical Research DCEA Lecture 4February 9, 2012Jose Luis Burgos, MD, MPH, AAHIVSUCSD Division of Global Public Health Department of Medicine

2. Today’s Objectives:Data Type, Quality & Source • To Understand the General Issues in Gathering and Presenting Health and Cost Data Inputs • To Understand Data Sources for Health and Cost Inputs • To understand how to present data sources in your manuscript

3. Tradeoffs--Refine the Model, Given Data Availability 1. CEA models usually have many inputs • In average 10 health and 10 cost inputs 2. Resources are limited a. Your time b. Your budget c. Time for decision to be made 3. Therefore, model can be modified to utilize reliable data currently available. Iterative process highlights critical vs. marginal components.

4. Best Estimates and Plausible Ranges 1. Best Estimate = Base Case a. The most likely value for the input: the value in the center of the best available data. b. You can intentionally err in one direction to prove the strength of your result. • 2. Plausible Range: similar to 95%, not 99.99%, C.I. • a. When using a single empirical data base, calculate a formal confidence interval (typically + or – 95%). • b. With multiple sources, informal use of best range.

5. Levels of Evidence • Systematic Review of RCTs with homogeneity • Systematic Review with some heterogeneity • Large RCTs • Small RCTs • Systematic Review of cohort studies • Individual cohort studies • Case control studies • Case series • Expert opinion

6. …Changes for different questions Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=1083

7. “an effective, safe, simple” intervention that wasn’t Circulation 1993; 87: 2043-2046 BMJ 1995 ; 310: 752-754

8. Health Inputs • Overview • Steps • How to Find Inputs

9. Health Inputs Overview 1. Health State Outcomes a. Relevant Outcome States b. Probability Estimates 2. Health Preferences Weights a. Preference Weights for Outcomes b. Utilities, QALYs 3. Population Characteristics a. Relevant Population b. Disease Prevalence in Population

10. Health Inputs - Steps • List Potential Health Outcome States and Relevant Population • Find Data on States & Probabilities - Start With Comprehensive Literature Search • Find Data on Utilities • Find Data on Population Characteristics

11. Health States Key Questions: • What Are the Relevant Health States Over Time for the Disease Under Study? • When do These States Occur, and How Long Do They Last? • For Which Health States, Are There Credible Estimates? • Are These Estimates Appropriate for Your RQ and for Your Population?

12. Preference Weights - Utilities a. Disease-specific Utilities b. Generic Utilities c. Key Questions: i. Do Credible Estimates Exist for Your RQ? ii. Are the Data Appropriate for Your RQ and Your Model? iv. Disease Specific Ratings v. Community Ratings vs. Patient Ratings CEA Registry: https://research.tufts-nemc.org/cear/Default.aspx

13. Population Characteristics a. Prevalence of the Disease b. Key Questions: i. What is the Relevant Disease Prevalence? ii. National, Representative Samples iii. Disease Surveillance Databases iv. Integrated Delivery System Databases v. Claims Databases c. What Competing Risks Exist (Unrelated to RQ)? d. Do Credible Estimates Exist? e. Are These Estimates Appropriate for Your RQ?

14. Where to Look for Health Inputs: First do an extensive literature review! • www.pubmed.gov (or, UCSF link) • Search and Sort options (e.g. Boolean Logic, MeSH) • Other Sources: Up to Date (www.uptodate.com) , Cochrane Database (www.cochrane.org), Google!

15. Other sources for specific variables

16. Cost Inputs • What costs to include • Identifying costs Direct Indirect • Time Costs

17. Opportunity Costs Is the value of good and services in there best alternative use In healthcare market prices rarely reflect what people end up paying Muennig 2008

18. Flu like illness Identify Costs Supportive care $0 Vaccinate $20 No inf. $0 Infection $12 No MD $0 MD $80 Recovers $0 Hospitalized $3,500 Recovers $0 Muennig 2008

19. Additional Costs Does not see MD Stays Home Goes to Work Misses Work Infects others Less Productive Muennig 2008

20. Muennig 2008

21. Looking for Direct Costs 1. Published Estimates 2. Resources Used x Cost per unit Used (e.g. previous slide) 3. Cost Data Bases

22. Costs must be Updated • Adjust using the medical component of the Consumer Price Index (CPI), maintained by the Bureau of Labor Statistics (BLS) • Substitute particular unit costs with updated values for the same services • Whichever method is used, all costs must be denominated in a single currency adjusted to a single year

23. Unit Costs • Reimbursements • Billed Charges • Cost Accounting Systems • Price References

24. Reimbursements a. Acceptable, especially if based on negotiated rates • Medicare reimbursement for inpatient care is based on prices established for DRGs (Diagnostic Related Groups) • Excellent approach: RBRVS (resource-based relative value scale) used by Medicare for outpatient services • When deductibles and copayments are charged, these should be included when calculating cost for the societal perspective • In some databases, “allowed charges” summarize total reimbursement

25. Billed Charges • Can be used • Must be adjusted with hospital department- specific cost-to-charge ratios • Even then, imperfect: a single cost-charge ratio is used for all services in a department

26. Price References • Drugs: “Pharmacy Red Book” of average wholesale prices • There are varied publicly available estimates for health worker hourly wages, diagnostic and laboratory equipment, and even for most supplies • ME: *** LOOK FOR THE WEB PAGES FROM WHO, etc.

27. Time Costs • Opportunity cost (to the patient & possibly caregivers) of receiving an intervention • Opportunity cost = value of activities foregone = value of lost work & household productivity • What time is properly counted? • How is time counted & valued?

28. What Time is Counted • Time required for the intervention is counted • Time lost due to the illness (care, disability, early death) is not counted: the valuation of this time is captured in the utility assessment, and should not be double-counted • Note that “intervention” vs. “illness care” varies across research questions: HIV is “illness” for an HIV prevention program, but part of “intervention” in a CEA on antiretroviral therapy

29. How is Time Counted & Valued? • Time Cost = Time Lost x Cost per Time Unit • Time lost is synthesized from estimates of the time required for an intervention • Assessment of informal (friends & family) care might require patient interviews • Cost per time unit is based on age- and gender-adjusted values from (frequently updated) published tables • Published time cost estimates are available for some illnesses

30. Example: Aneurysm Analysis Cost input Value (range) Source Clipping $25,150 (18,000-35,000) Cohort study – cost accounting system Moderate/severe disability $20,000/yr (13,000-30,000) Published estimate SAH hospitalization $47,000 ($33,000-$67,000) Cohort study – cost accounting system Discount rate 3% (0-5) CEA guidelines Time Costs Not Included - Could be based on the time for surgery and recovery. Assuming one month of lost time, at 10 hours/day and $10/hour = $3,000.

31. Where to look!

32. Disease classification systems

33. Current Recommendations*:US Panel on Cost-effectiveness in Health and Medicine • Use Societal Perspective for Calculating Resource Units and Costs • Include All “Relevant” Direct Costs • Exclude Time (“Productivity”) Costs associated with illness, but include those associated with the intervention • Include Variable Costs, but Exclude Fixed Costs • Use Incremental Costs Rather Than Average Costs * See Gold MR et al. for Complete Set of Recommendations

34. Presentation/Transparency* • * Societal Perspective, Funding R01-123456 • Clearly Stated Reference / Base Case • Clearly Stated Data Source, Perspective, and Potential Conflicts of Interest • Sensitivity Analysis Across Range of Values • Clearly Stated Discount Rate

35. OK!, Let’s do an exercise!

36. Cost-to-Charge Ratios for InfluenzaStep 1 We will use the Health Care Utilization Project (HCUP) online website for average hospital costs for influenza, (ICD-9: 487) • Go to: http://hcupnet.ahrq.gov/ • Click on National Statistics on All States • Click on “Researcher” • Go to “Statistics on specific diagnosis • Select “2009” • Select Specific diagnosis by ICD-9 • Select “Principal Diagnosis” • Write 487, click on “all codes combined” -> Next • Select “Hospital Charges” only • Select: “All patients in all hospitals” -> Next Write Total Charges (mean) $__________) Average costs: _____________ • For Medical Provider Analysis and Review (MEDPAR) Type: http://www.cms.gov/MedicareFeeforSvcPartsAB/03_MEDPAR.asp#TopOfPage Covered charges (2):_____________ Medicare reimbursement (3): _________

37. Cost-to-Charge RatiosStep 2 • Go to: Medical Expenditure Panel Survey (MEPS): http://www.cms.gov/MedicareFeeforSvcPartsAB/03_MEDPAR.asp#TopOfPage • Select 2009, by DRG [COL 1] • We can use DRG 79 (“Infectious and inflammatory respiratory conditions” ) • Collect data on “Covered Charges” [COL 3] :_____________ “Medicare Reimbursement” [COL 4]: ___________

38. Cost-to-Charge RatiosStep 3 • Calculate: AvrgChrgs ($______) * Med. Reimb ($______) Covered Charges ($______) = Rough estimate of opportunity cost: $______ What is the cost-to-charge ratio?: _______

39. Appendix: Useful formulas • Discounting for future Costs • Inflation of costs to current monetary values • Calculating transition probabilities http://www.bls.gov/data/inflation_calculator.htm PV =Vt*(1+r)t Jerome has HIV and LTBI, his chance of TB is 10% each year. What is his risk for 10 years?

40. Questions…??!!