Econ Lecture 2

  1. Factors of Quality Health Care
    • High value (consumer)
    • Most valuable service for price (employer)
    • Efficient allocation of resources (payer)
    • Offer most appropriate treatment (provider)
  2. Off label use of second generation anticonvulsants
    83% used off label
  3. treatment of anemia among women with chronic kidney disease in US outpatient settings
    • outcomes research because survey is conducted in the physicians office
    • may show regional variation
  4. evaluation of asthma related utilization in a managed care population following FDA public health advisory on long acting beta2-agonists.
    • investigated a possible change in medical and pharmacy use of antiasthmatics focusing on prevention
    • change in prescribing patterns following a FDA advisory
    • see who is complying after the health advisory
  5. Why does HOR matter to pharmacists?
    • New role for pharmacists
    • assessment of care
    • development of services
    • provide accountability and improve knowledge base
    • increase patient knowledge
    • improve medication compliance
    • decrease misuse and abuse
  6. Definition of outcomes research
    research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcomes, improved health, lowered morbidity and improvement of abnormal states.
  7. Aim of outcomes research
    improve healthcare and achieve the optimum benefit from the resources available
  8. Measure of outcomes research
    • impact of diseases on populations
    • clinical and economic value of healthcare interventions to patients, payers, providers and employers
    • impact of diseases and their treatments on patient reported outcomes
  9. Why conduct outcomes analysis
    • to make market decisions (quality of care provided by clinicians)
    • to provide accountability (payers know quality of care is good)
    • to improve the knowledge base of medicine (evidence based medicine)
  10. Outcomes Research Inputs and Outputs
    • Inputs:
    • Clinical, social, economic, data
    • Outputs: Messages to providers
  11. SPO Framework
    • Structure
    • Process
    • Outcomes
  12. Structure
    • elements of medical care that are associated with of service.
    • availability of insurance coverage
    • access to facilities
  13. Process
    • intervention being tested for effectiveness
    • Mammography screening
  14. Outcomes
    • outcome of the structure and process
    • ex. increased life expectancy from early detection of cancer
  15. Role of outcomes research in pharmaceutical product development and marketing.
    • Research and development strategy
    • pricing and reimbursement strategy
    • communication to clinicians, payers and patients
  16. Outcomes research vs. clinical research
    • Outcomes research = effectiveness, QOL, cost, treatment, resources, satisfaction
    • Clinical research = efficacy and physiologic outcomes under controlled circumstances
  17. Epidemiologic observational approach
    used in most outcomes research studies is a naturalistic technique that relies on data collected in actual practice or real world settings
  18. Steps of outcomes research (conceptual model)
    • Indicate what is believed to cause the outcome
    • Identify which variables are pertinent to the study at hand
    • Identify the variables and their relationship to outcomes
  19. Execute analysis plan (next steps)
    • Most outcomes relying on epidemiology will be multivariate
    • Models incorporate statistical techniques to handle bias
    • Dependent and predictor variables
    • Interpret results
    • Conclusion and implication
  20. Multivariate Model
    • more than 2 variables
    • independant and dependant
    • variables that impact outcomes
  21. Retrospective Data Analysis
    • Claims data
    • Administrative database
    • Patient medical records
  22. Primary Data
    collected solely for the purpose of research
  23. Secondary Data
    Hospital records, physician charts, HMO databases
  24. Therapeutic Evaluation
    Clinical variables are recorded at baseline and and each subsequent visit to record changes/improvments
  25. Non-Therapeutic Evaluation
    Outcomes are obtained from the patient using questionnaires or claims data
  26. Patient Reported Outcomes
    • captures data directly from patients
    • Use of PRO in product labeling
  27. Major types of Patient Reported Outcomes
    • Health related QoL
    • Functional Status
    • Symptom eval
    • Adherence to therapy
    • Patient satisfaction
    • ability and willingness to pay
  28. Roles of PRO
    • Endpoint selection
    • Label claims development
    • instrument development
    • implementation of trials in your work
  29. Pharmacoeconomic Outcomes
    cost efficiency of the medication
  30. Therapeutic Outcomes
    therapeutic effectiveness
  31. Non-Therapeutic outcomes
    • # of visits to the ER
    • # of hospital admissions
    • Quality of life outcomes
  32. Adherence Measurements
    • Medication possession ratio
    • Medication refill adherence
    • Medication persistence
    • Index-Period (fill dates)
    • Medication Event monitoring system (special cap)
    • Drug copayments and adherence
  33. Quality of life
    • Utility
    • impact of disease and treatment relative to well being of patient
  34. Quality of life measurements
    • patient's perception of well-being
    • how changes in therapy alter QOL
  35. Health Related QoL Assesments
    • Health Status Assesments
    • Patient preference assesment
  36. Health Status assesment
    • Most widely used in clinical trials comparing treatments
    • Self-assessment of well being
    • used to compare groups of patients receiving different treatments or a single treatment
    • Functional Living Index - Cancer
    • European organization for research and treatment of cancer
    • Functional assesment of cancer therapy
  37. Patient Preference Assesments
    • Seldom used in clinical trials
    • Reflect an individual's decision making process
    • Time trade off: trade off between quantity and quality of life
    • Standard gamble: measure preferences under uncertainty, gold standard
    • visual analogue scale; ranking
  38. Generic Instruments
    • allow comparison across programs and conditions
    • not responsive to fine differences between conditions
    • assess HRQoL in patients with or without disease
    • useful in comparing completely different groups
  39. Disease specific instruments
    • Detects aspects of HRQoL in a specific disease
    • Higher responsiveness to change
  40. Criticisms/barriers to outcomes evaluation
    • outcomes may be due to many factors
    • poor outcome does not immediately tell you what needs to be changed
    • collection of info requires effort, time and money
    • outcomes are probability statements
    • dependence on intermediate outcomes
  41. Comparative effectiveness research
    compares 2 drugs/therapies to find the best scenario for a patient
  42. Funding for CER in recently enacted stimulus package
    1.1 billion
  43. Health and Health Care in the US
    • US spends more on healthcare than others
    • Outcomes of US healthcare systems are not better
    • Variations on cost and care in different regions of the US
  44. The outcomes movement
    • geographic variations in practice patterns
    • poor relationships between costs and outcomes
    • need to establish best practices
    • cost containment
    • recognition of limited resources
    • improved management and accountability
  45. Information Gap
    Drug development and approval process does not provide evidence necessary to clinicians or policy makers to choose between drugs for the same indications
  46. CER: 6 Characteristics
    • informing a specific clinical decision from patient perspective or health policy from a population perspective
    • compare at least 2 alternative interventions
    • describes results at population and subgroup levels
    • measures both benefits and harms
    • appropriate methods and data sources
    • conducted in similar settings to practice
  47. Primary Comparative effectiveness
    • Retrospective observational studies
    • Prospective observational studies (clinical trial)
    • cluster randomized studies
    • Registry based studies
  48. Secondary comparative effectiveness
    • systematic review and meta analysis
    • modeling and decision analysis
    • review other findings and compare
  49. Limitations of Primary CER
    • Nonrandomized shows only association not causality
    • lack of randomization may lead to selection bias or confounding data
    • retrospective claims are limited to accuracy of coding
  50. Limitations of Secondary CER
    • problems in literature identification
    • publication bias
    • methods of analysis
Card Set
Econ Lecture 2
comparative effectiveness research and outcomes research