Econ Lecture 2

• High value (consumer)
• Most valuable service for price (employer)
• Efficient allocation of resources (payer)
• Offer most appropriate treatment (provider)

83% used off label

• outcomes research because survey is conducted in the physicians office
• may show regional variation

• 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

• 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

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.

improve healthcare and achieve the optimum benefit from the resources available

• 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

• 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)

• Inputs:
• Clinical, social, economic, data
• Outputs: Messages to providers

• Structure
• Process
• Outcomes

• elements of medical care that are associated with of service.
• availability of insurance coverage
• access to facilities

• intervention being tested for effectiveness
• Mammography screening

• outcome of the structure and process
• ex. increased life expectancy from early detection of cancer

• Research and development strategy
• pricing and reimbursement strategy
• communication to clinicians, payers and patients

• Outcomes research = effectiveness, QOL, cost, treatment, resources, satisfaction
• Clinical research = efficacy and physiologic outcomes under controlled circumstances

used in most outcomes research studies is a naturalistic technique that relies on data collected in actual practice or real world settings

• 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

• Most outcomes relying on epidemiology will be multivariate
• Models incorporate statistical techniques to handle bias
• Dependent and predictor variables
• Interpret results
• Conclusion and implication

• more than 2 variables
• independant and dependant
• variables that impact outcomes

• Claims data
• Administrative database
• Patient medical records

collected solely for the purpose of research

Hospital records, physician charts, HMO databases

Clinical variables are recorded at baseline and and each subsequent visit to record changes/improvments

Outcomes are obtained from the patient using questionnaires or claims data

• captures data directly from patients
• Use of PRO in product labeling

• Health related QoL
• Functional Status
• Symptom eval
• Adherence to therapy
• Patient satisfaction
• ability and willingness to pay

• Endpoint selection
• Label claims development
• instrument development
• implementation of trials in your work

cost efficiency of the medication

therapeutic effectiveness

• # of visits to the ER
• # of hospital admissions
• Quality of life outcomes

• Medication possession ratio
• Medication refill adherence
• Medication persistence
• Index-Period (fill dates)
• Medication Event monitoring system (special cap)
• Drug copayments and adherence

• Utility
• impact of disease and treatment relative to well being of patient

• patient's perception of well-being
• how changes in therapy alter QOL

• Health Status Assesments
• Patient preference 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

• 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

• 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

• Detects aspects of HRQoL in a specific disease
• Higher responsiveness to change

• 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

compares 2 drugs/therapies to find the best scenario for a patient

1.1 billion

• 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

• 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

Drug development and approval process does not provide evidence necessary to clinicians or policy makers to choose between drugs for the same indications

• 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

• Retrospective observational studies
• Prospective observational studies (clinical trial)
• cluster randomized studies
• Registry based studies

• systematic review and meta analysis
• modeling and decision analysis
• review other findings and compare

• 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

• problems in literature identification
• publication bias
• methods of analysis