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Introduction to Outcomes Research
Laura T. Pizzi, PharmD
Office ofHealth Policyand ClinicalOutcomes
Overview
• Economics of the Healthcare Marketplace (Evolution of OR)
• Definitions• When OR is Conducted• Types and Examples of Outcomes• Study Perspectives • Study Designs
Perfect Market:Perfect Market:
Many BuyersMany Buyers
Many SellersMany Sellers
Perfect Market:Perfect Market:
Many BuyersMany Buyers
Many SellersMany Sellers
Fee-for-Service
Fee-for-Product
Economics of the Healthcare Marketplace
Healthcare Market:Healthcare Market:
Many BuyersMany Buyers
Few SellersFew Sellers
““Gatekeepers”Gatekeepers”
Healthcare Market:Healthcare Market:
Many BuyersMany Buyers
Few SellersFew Sellers
““Gatekeepers”Gatekeepers”
Discounted Fee-for-Service
Capitation
With-holds
1.9
0.8
-1.8
5.6
-0.9
-0.1
1.5
3
-1.6
3.2 3.1
2.1
-3.5
0.5
2.3
3.5
-4
-3
-2
-1
0
1
2
3
4
5
6
1995 1996 1997 1998
IndemnityPPOPOSHMO
U.S. Healthcare Cost Increases (%)*1995-1998
*William M. Mercer, Inc. National Survey of Employer-Sponsored Health Plans. 1998.
Why is Outcomes Research Important?
• Healthcare market is imperfect– Result is need to determine value of
healthcare resources• Pharmaceutical Manufacturers• Managed Care Organizations• Pharmacy Benefit Managers (PBMs)• Hospitals/Health Systems• Government Providers (Medicare, Medicaid)• Society
Definition
Outcomes Research evaluations are concerned with evaluating
the effects of medical intervention on clinical,
economic and humanistic measures.
IDENTIFY KEYDEVELOPME NTOPPORTUNITIES
IDENTIFY KEYDEVELOPME NTOPPORTUNITIES
PROOF OF CONCEPTPROOF OF CONCEPT DETERMINE SAFETY,EFFICACY , VALUE
DETERMINE SAFETY,EFFICACY , VALUE
OBTAINREGULATORY
APPROV AL
OBTAINREGULATORY
APPROV AL
MARKETTHE DRUGMARKET
THE DRUG
MAXIMIZECOMM ERCIALOPPORTUNITY
MAXIMIZECOMM ERCIALOPPORTUNITYPREPARE THE MARKETPREPARE THE MARKET
Market & MedicalNeeds AssessmentMarket & Medical
Needs Assessment
Disease ModelingDisease Modeling Outcomes Research Planning and Implementation/P ricingOutcomes Research Planning and Implementation/P ricing
Advisory Boards (Opinion Leaders, Providers, Payers)Advisory Boards (Opinion Leaders, Providers, Payers) Sales/Field Force TrainingSales/Field Force Training
NP Strategy Development and ImplementationNP Strategy Development and Implementation Phase IV Studies (Clinical & Outcomes)Phase IV Studies (Clinical & Outcomes)
Advertising and Communication Planning and ImplementationAdvertising and Communication Planning and Implementation
Training (S peaker, MSLs)Training (S peaker, MSLs)
Publ ication StrategyPubl ication Strategy
Knowledge ManagementKnowledge Management
Team Structure, Behavior, TrainingTeam Structure, Behavior, Training
Pre-Phase I Phase I Phase IIA Phase IIB Phase IIIA Phase IIIB Phase IV End ofOpportunity
Competi tor StrategiesCompeti tor Strategies
Message MappingMessage Mapping
Disease Management P lanning and ImplementationDisease Management P lanning and Implementation
When is Outcomes Research Conducted?
Study Perspectives
• Patient• Provider
– Physician– Hospital/Clinic
• Payer– Health plan– Employer– Government
• Societal
Types of Outcomes
• Clinical
• Economic
• Humanistic
Clinical Outcomes
• Definition: Medical events that occur as a result of disease or treatment*
• Examples– Pain Relief– Cure of Infection– Myocardial Infarction– Death
*Bungay KM and Sanchez LA. Types of Economic and Humanistic Outcomes Assessments. In: Pharmacoeconomics and Outcomes: Applications for Patient Care (module 1). Kansas City: American
College of Clinical Pharmacy, 1996.
Humanistic Outcomes
• Definition: Consequences of the disease or treatment on patient functional status or quality of life*
• Examples– Health Related Quality of Life (HR-QoL)– Patient Satisfaction– Functional Status– Patient Preferences
*Bungay KM and Sanchez LA. Types of Economic and Humanistic Outcomes Assessments. In: Pharmacoeconomics and Outcomes: Applications for Patient Care (module 1). Kansas City: American
College of Clinical Pharmacy, 1996.
Patient Satisfaction
• Definition: A consumer’s evaluation of the care received that indicates the extent to which their needs and wants are met*
• Influenced by patient attitudes, values, and expectations
• Typically measured by process and structure variables
• Examples of Measurement Instruments– Patient Satisfaction Questionnaire (PSQ)– Press-Gainey Survey
*Johnson JA. Patient Satisfaction. In: Pharmacoeconomics and Outcomes: Applications for Patient Care (module 3). Kansas City: American College of Clinical Pharmacy, 1996.
Health-Related Quality of Life
• Definition: Those aspects of life that are dominated or significantly influenced by personal health or activities performed to maintain or improve health*
• Domains:Physical, mental, social, and general health perceptions
• Measurement Instruments– General: l: MOS SF-36, SF-12, SIP, Nottingham Health
Profile– Disease-Specific: Diabetes Impact Measurement Scale,
Asthma TyPE Specification, WOMAC Osteoarthritis Index
*Bungay KM and Sanchez LA. Types of Economic and Humanistic Outcomes Assessments. In: Pharmacoeconomics and Outcomes: Applications for Patient Care (module 1). Kansas City: American
College of Clinical Pharmacy, 1996.
Economic Outcomes
• Definition: Direct, indirect, and intangible costs compared with the consequences of medical treatment alternatives
• Examples– Drug Costs– Office Visits– ER Admissions– Inpatient Length of Stay– Productivity
*Bungay KM and Sanchez LA. Types of Economic and Humanistic Outcomes Assessments. In: Pharmacoeconomics and Outcomes: Applications for Patient Care (module 1). Kansas City: American
College of Clinical Pharmacy, 1996.
Brainstorm Exercise: What Outcomes Are Important?
Asthma
Diabetes
Influenza
Past Present Future
Retrospective Studies
Database Analysis
Chart Review
Prospective Studies
Cohort Studies
Randomized, Controlled
Models
Decision Analysis
Cost-Effectiveness
Cost of Illness
Cost-Consequence
Outcomes Research Study Designs
Introduction to Pharmacoeconomics
Laura T. Pizzi, PharmD
Office ofHealth Policyand ClinicalOutcomes
Overview
• “Who” and “When” of Pharmacoeconomics• Key PE Concepts• Forms of Cost• Types and Examples of Pharmaceconomic
Studies• Assignment of Article Reviews
Definition of Pharmacoeconomics
• “The description and analysis of the costs of drug therapy to health care systems and society” - Townsend, 1987
• Consists of the identification, measurement, and comparison of costs and consequences of pharmaceutical products and services
• A micro-science related to Health Economics
Questions That May Be Answered Through
Pharmacoeconomics
• What therapeutic areas should be targeted for drug development?
• Should [new drug] be developed by our pharmaceutical company?
• Should [new drug] be added to our formulary?• What is the drug’s cost in relation to clinical
benefit when QoL is considered?• Should [new drug] be covered by a Medicaid
plan?
TargetTherapeutic
Areas
ClinicalResearch:
Phase I
Phase II
Phase III
Postmarketing:
Phase IV
Adapted from: Bootman LJ, Townsend RJ, and McGhan WF. Principles ofPharmacoeconomics. Cincinnati, OH: Harvey Whitney Books Company, 1996
Investigational
Seller (Rx Company)
Approved
Buyers (HC Providers)
When are Pharmacoeconomic Studies Conducted?
Key Pharmacoeconomic Concepts
• Discount Rate• Utility• Sensitivity Analysis• Study Perspective • Quality-Adjusted Life Years (QALYs)• Charges vs. Reimbursement Rates vs.
Costs• Units (Natural vs. Monetary)
Definition of Cost
“The [monetary] value of all goods, services, and other
resources that are consumed in the provision of an
intervention or related consequences”*
*Luce et al. Estimating costs in cost-effectiveness analysis. In: Gold, et al. Cost-Effectiveness in Health and Medicine. 1996.
DirecDirectt
IndirectIndirect
MedicalMedicalNon-MedicalNon-Medical
InpatientInpatient
HospitalizationsHospitalizations
ProceduresProcedures
DrugsDrugs
Laboratory TestsLaboratory Tests
Rehab/SNFs/Nursing Rehab/SNFs/Nursing HomesHomes
OutpatientOutpatient
Office VisitsOffice Visits
ProceduresProcedures
DrugsDrugs
Laboratory TestsLaboratory Tests
CostsCosts
Types of Costs
• Fixed costs
• Variable costs
• Opportunity costs
• Average costs
• Marginal costs
• Incremental costs
Forms of Cost*
*Earl-Slater, et al. Dis Manage Health Outcomes. 1997;2(2):65-76.
Sources of Data for Direct Medical Costs
• Local Costs– Patient bills – Provider-specific
claims data– Activity Based
Costing
• National or Regional Costs– National Hospital
Discharge Survey– HCFA– MEPS (NMES)– HCUP
Types of Pharmacoeconomic
Studies• Cost-of-Illness
• Cost-Consequence
• Cost-Minimization
• Cost-Effectiveness
• Decision Analysis
• Cost-Benefit
• Cost-Utility
Cost of Illness
• Evaluation of all economic and humanistic resources associated with a given illness/disease
• Examples– Cost of asthma– Cost of strokes
caused by phenylpropanolamine (PPA)
Cost-Consequence Analysis
• Evaluation of all clinical, economic, and humanistic outcomes associated with an intervention or group of interventions
• Example– Review of a new
migraine drug for addition to a hospital formulary
• Clinical outcomes (HA relieved)
• Economic outcomes (direct & indirect costs)
• Humanistic outcomes (productivity loss)
Cost-Minimization Analysis
• Used when two or more interventions are considered to have equivalent outcomes
• Examples– Flouroquinolone
versus SMX/TMP for the treatment of urinary tract infection
– Prilosec versus Prevacid for the treatment of duodenal ulcers
Cost-Effectiveness Analysis
• Evaluation of the costs of an intervention in relation to the outcome, where the outcome is expressed in natural units
• Examples
Cost of inhaled steroid ($)
Asthma Exacerbation
Prevented
Cost of levofloxacin ($)
Infection Cured
Decision Analysis
• A modeling technique where results of prior research studies and expert consensus are used to project the effects of a medical intervention to the population of use
• Also called “Decision Trees”
Cost-Benefit Analysis
• Evaluation of the costs of an intervention in relation to the outcome, where the outcome is expressed in dollars
• Example
Cost of a Heart Drug($)
Reduced Hospital Days ($)
Cost-Utility Analysis
• Evaluation of the cost of an intervention in relation to humanistic-adjusted outcome expressed in natural units
• Examples
Cost of Stroke Treatment
QALY after Stroke
Cost of Headache Medication
Sick Days
Laura T. Pizzi, PharmD
Office ofHealth Policyand ClinicalOutcomes
Use of Surveys in Health Services
Research
Overview
• Applications of surveys in health services research• Why survey?• Established instruments• Study design• Key measures of survey quality• Survey research process• Administration methods• Developing a quality survey• Potential limitations of surveys
Terminology
“Survey” = “Instrument” = “Questionnaire”
“Index” or“Scale” usually refers to question(s) that require(s) rating
In clinical trials, investigator surveys may be called “Case Report Forms” or “Encounter
Forms”
What are the applications of surveys in health services
research?• Traditional clinical research
• Outcomes research– Clinical– Economic– Humanistic– Satisfaction
Why survey?
• Limitations associated with other data sources
• Can be cheaper than other research methods• Marketing objectives
– Determine patient satisfaction– Improve medication persistency
• Many established scales are available
Established Instruments:Some Examples
• Quality of Life: SF-12, SF-36
• Pain: Visual Analog Scale (VAS)
• General Health: Clinical Global Impression (CGI)
Important Considerations Regarding Established
Instruments• Always search the literature for established instruments
before creating your own
• Instruments shown to be reliable/valid in a previously-studied population may not be reliable/ valid in your population
• Changing the method of administration may effect reliability/validity
• “Cutting and Pasting” destroys reliability and validity of established instruments
• Some established surveys may require you to obtain permission for use and/or a small usage fee
Study Design
• Time Frame– Longitudinal– Cross-sectional– Case-control (Group Comparison)
• Descriptive versus Analytical
Descriptive versus Analytical Studies
Descriptive Studies• Describe characteristics
of group(s)• Answer the question
“What?”• Comparison group(s)
not required• No hypothesis needed
Analytical Studies• Explain characteristic(s)
of group(s)• Answer the question
“Why?”• Require comparison
group(s)• Hypothesis needed
Key Measures of Survey Quality
• Reliability
• Validity
Survey Research Process
Develop Questions
Format Survey
Pretest Survey Administer
Survey
Re-administer
Survey
Enter Data
Code Data
Analyze Data
Report ResultsReport Results
Write Report
Survey Administration Methods
• Self-administered– Mail
– Web
• Interview– Telephone
• Traditional• Technology-Enhanced
– Random Digit Dialing– Interactive Voice Response– Computer-Assisted Telephone Interview (CATI)
– In-Person (Face-to-Face)
Advantages & Disadvantages of
Available Survey MethodsCost Response
RateAmount ofData
Data EntryTime
Mail Low Mod Mod High unlessOCR
Web Low Depends Small Low
Telephone Mod (if IVR);High (if LiveOperator)
High Mod-High High unlessCATI
Live High High High High
Developing a Quality Survey:“The Devil is in the Details”
• Formatting• Question and questionnaire length• Response options• Branching• Introduction / cover letter• Directions for completion• Incentives• Sample (should be representative of target
population)
Potential Limitations of Surveys
• Bias (What kinds?)• Sampling issues
– Sample size– Sample characteristics
• Response rate• Time (especially for mail surveys)• Uncertain reliability/validity• Not good for demonstrating causality
Disclaimer
• “This workforce solution was funded by a grant awarded under the Workforce Innovation in Regional Development (WIRED) as implemented by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This solution is copyrighted by the institution that created it. Internal use by an organization and/or personal use by an individual for non-commercial purposes is permissible. All other uses require the prior authorization of the copyright owner.”
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