A Primer on Outcomes Research
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![Page 1: A Primer on Outcomes Research](https://reader035.fdocuments.in/reader035/viewer/2022062721/5681383e550346895d9fe96e/html5/thumbnails/1.jpg)
Vidya Sharma MBBS, MPH.
A Primer on Outcomes Research
The Children’s Mercy Hospital
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Objectives
• Understand the principles of outcomes research.
• Define outcome measures and variables
• Understand the advantages/limitations of the outcomes research.
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The Promise of Health ServicesResearch
“Health services research can save more
lives in the next decade then can bench
science, work on the human genome,
stem cell therapy and cancer research..”
Atul Gawande MD
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Health Services Research inPediatrics
• A core body of pediatrics relevant
health services literature already exists
• Outcomes research
• Patient satisfaction research
• Expert practice
• Utilization research
• Health disparities
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Outcomes Research
• What is outcomes research?– Outcomes research studies the end results of
medical care– End results include effects that people experience
and care about, such as change in the ability to function
– For individuals with chronic conditions end results include quality of life as well as mortality
– The effects of the health care process on the health of patients and populations
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Outcomes Research
• What works?
• For which patients?
• At what cost?
• From whose perspective?
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Case
• 5 year old fell from a grocery cart
• Dazed 60 seconds
• Lethargic 20 minutes
• Exam –no focal findings
• CT frontal fracture no i/c bleed
• Observed 6 hours and d/c with follow up with PCP
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Clinical Research
• Duration of altered mental status
• Vomiting
• Cost of care
• Rates of return to ED
• Disposition: discharge, admit, death
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Outcomes Research
• Clinical effectiveness: evidenced based treatment• Quality of care: adherence to clinical guidelines• Quality of life: return to normal activities• Patient satisfaction: satisfaction with discharge
instructions, seen in a timely manner• Cost effectiveness: comparisons of admission vs
observation, CT or not• Organization of care: pre-hospital, referral
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Domains of Outcomes Research
• Clinical effectiveness• Quality of care• Quality of life• Patient satisfaction• Organization of care
• Death• Disease• Disability/Discomfort• Dissatisfaction• Dollars
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Types of Outcomes Research
– Evaluating effectiveness of medical/ surgical procedures
– Measuring impact of insurance/ reimbursement policies on outcomes of care
– Development and use of tools to measure health status
– Analyze the best way to disseminate results to encourage physician/consumer behavior change
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What makes Outcomes Research different?
• The question it asks
• The settings it studies
• The method it uses
• The health status it measures
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What makes Outcomes Research different?
• The questions it asks– all aspects of the health care delivery system– clinical encounter– organization of the health care system– financing of the health care system– regulation of the health care system
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What makes Outcomes Research different?
• The question it asks
• The settings it studies
• The method it uses
• The health status it measures
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What makes Outcomes Research different?
• The setting it studies
– contrast with randomized controlled studies• efficacy studies
– research in real-life settings• effectiveness studies
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Definitions
• Efficacy– Probability of benefit from an intervention
under standardized or ideal conclusions– Randomized control trials
• Effectiveness Studies– Results achieved in actual practice with
different patients and providers– Research in real life settings
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What makes Outcomes Research different?
• The question it asks
• The settings it studies
• The method it uses
• The health status it measures
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What makes Outcomes Research different?
• The methods it uses– use existing computerized databases– patient questionnaires– meta-analysis– complement standard strategies
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Types of Projects Using Databases
• Health Services Research– Data is used to examine access, use, costs,
delivery, and organization of health services to better understand the structure and effects of health services for populations
• Intervention Projects– A therapy or practice is compared with similar
populations which do not use therapy
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Types of Studies
– Adherence to clinical practice guidelines– Costs of Care– Resource utilization of special groups of
patients– Use of specific therapies– Pharmaceutical use
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Observational Studies
• Cohort study– Patients with exposure X differ from patients
without exposure X on an outcome
• Case Control Study– Do cases differ from controls on some exposure
• Historical Controls Study– Outcome of interest compared with historical
records
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Contrasting RCTs with Observational studies
RCT• error on side of not finding
an effect • generalizability limited to
patient group studied
• populations are equivalent
• small differences can be detected
• small numbers of patients
Observational• error on side of finding an
effect
• ordinary medical practice
• adjust for differences by multivariate analysis
• large differences can be detected
• large numbers of patients
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Observational Studies
• Association is not always causation
• Causation is implied when:– Strength (large risk, rules out other factors)
– Consistency (replicated by different researchers and in different conditions)
– Specificity (exposure related to a specific disease than a wide range)
– Temporality (exposure preceded disease)
Hill B. The Environment and Disease, Association or Causation? 1995.Proc R Soc Med;58:295.
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Observational Studies
• Causation is implied when:– Biological Gradient (dose related response)– Plausibility (credible scientific explanation)– Coherence (association consistent with natural history of the
disease)– Experimental evidence (physical intervention shows results
associated with the association)– Analogy (similar result that we can draw a relationship to)
http://www.childrens-mercy.org/stats/ask/causation.asp
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Health Services Research
Goodman DM, Mendez E, Throop C, Ogata ES: Adult survivors of pediatric illness: the impact on pediatric hospitals. Pediatrics 2002;110:583-589.
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Adult Survivors
• Observational study using PHIS, covering the years 1994-1999
• Described the demographics of adult in-patients in pediatric facilities
• Used census data to estimate national impact
• Used HCFA data to estimate financial impact across continuum of care
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Adult Survivors
6.198.497.48Average LOS
86,18817853863Number of patients
103,73321275051Number of discharge episodes
All Ages21-64 Years Old
18-64 Years Old
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Adult Survivors
3.1%6.3%Adult charges/ total charges
2.1%4.9%Adult disch/ total disch
35%/0.8%27%/13.6%32%/7.4%Medicaid/
Medicare
$20,444$31,114$26,640Avg charge/
discharge
All Ages21-64 Years Old
18-64 Years Old
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Adult Survivors
11.09.9Congenital heart disease
5.67.6Malignancy
34.521.8Cystic fibrosis
10.710.2Mental retardation/cerebral palsy
21-64 years old
(% of pts)
18-64 years old
(% of pts)
Diagnostic Group
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Total Number of Patients 1994-1999
0
500
1000
1500
2000
2500
1994 1995 1996 1997 1998 1999Year
18+_#pts21+_#pts
Adult Survivors
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Intervention StudyTodd J, Bertoch D, Dolan S: Use of a large
national database for comparative evaluation of the effect of a bronchiolitis/viral pneumonia clinical care guideline on patient outcome and resource utilization. Arch Pediatr Adolesc Med 2002;156:1086-1090
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Bronchiolitis/Viral pneumonia
• Clinical guideline developed and implemented
• Effect of guideline determined by internal comparison across time and external comparison using PHIS
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Bronchiolitis/Viral pneumonia
0
10
20
30
40
50
60
70
80
1994(pre) 1995 1996 1997YEAR
% U
TIL
IZA
TIO
N
CPT RSV TEST ICU Admission RIBAVIRIN
O.R =0.67 (0.60, 0.75)
O.R. = 0.43 (0.28, 0.68)
O.R. = 0.77 (0.66, 0.90)
O.R. = 0.72 (0.64, 0.80)
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Bronchiolitis/Viral pneumonia
Reduction of Low Severity Cases Admitted to TCH
0
10
20
30
40
50
60
70
1994 1995 1996 1997YEAR
% o
f C
AS
ES
Severity 1 Severity 2 Severity 3 Severity 4
P = 0.003
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Bronchiolitis/Viral pneumonia
0
10
20
30
40
50
60
70
80
1994(pre) 1995 1996 1997
YEAR
% U
TIL
IZA
TIO
N
$0
$50,000
$100,000
$150,000
$200,000
$250,000
Est
ima
ted
Ch
arg
e
Re
du
ctio
n
Estimated Charge Reduction CPTRSV TEST ICU AdmissionRIBAVIRIN
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Care for Cystic Fibrosis
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Best or Worst Patient Outcomes?
• Best and worst Cystic Fibrosis centers
offered the virtually the same
treatments to patients!!
• Striking differences in the way that care
was delivered within centers
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Results
• The best Cystic Fibrosis Center had leadership from someone who:
• Aggressively pursued consistency of care
• Individualized his approach to each patient
• Engaged patients in their own care process
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Potential Pitfalls
• Original goals for which the data was collected may not coincide with subsequent use
• Dataset may not have been designed or maintained to maximize consistency or data quality
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Potential Pitfalls
• More data collected than needed
• Infrequently used data elements may be unreliably coded
• Codes may change over time
• Geographic variation in coding
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Issues with Databases
• Required data elements– Are they present?– Are they properly coded?– Principal diagnosis only– All diagnoses
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Issues with Databases
• Sampling – what population?– which hospitals?– what data?
• Record Structure– Discharge episode– Clinical data
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Approach to using secondary Data
• Clearly define your question:– P population– I intervention– C comparison groups– O outcome
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Planning a Database Project
• It always takes longer than you think• Would you read it if someone else wrote it?• Being better is more important than being the first• Will the results be worthwhile no matter what you
find?• The probability of success is inversely related to the
number of collaborators.
Goldman l, et al. J of Gen Int Med. 1986;1 (Suppl):S25-S30.
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What makes Outcomes Research different?
• The question it asks
• The settings it studies
• The method it uses
• The health status it measures
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What makes Outcomes Research different?
• The health staus it measures– Traditional: more proximal outcomes
• laboratory test results
• complication rates i.e. infections
• death
– Outcomes: measures distal outcomes• functional status
• patient well-being / quality of life
• satisfaction with care
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How is health status measured?
• Questionnaires that measure aspects of health– Functional Status– Well- being / quality of life– Satisfaction with Care
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How is health status measured?
• Functional status– physical functioning i.e. walking,etc– role functioning i.e. going to school etc– social functioning i.e. playing with friends
etc
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How is health status measured?
• Well-Being / quality of life– mental health i.e. general mood– health perceptions i.e. person’s view of
health– quality of life– pain i.e. the extent of pain experienced
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How is health status measured?
• Satisfaction with care– access– convenience– information received– financial coverage– technical quality
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C h ar ac te r is t ic s o f th ein d iv id u a l
B io lo gic a l a n dp h y sio lo gic a l
v a r ia ble sS y m p to n s ta tu s
F u n c tio n a ls ta tu s
G en er a l h ea lthp er c ep tio n s
O v er a ll q u a lityo f lif e
C h aract eris t ics o ft h e en v iro n m en t
N o n m ed ic a lf ac to r s
Ps y ch o lo g ica lS u ppo rt s
S o cia l a n d Ps y ch o lo g ica lS u ppo rt s
V a lu e s a n d Pre fe re n ce sS y m pto m A m plif ica t io n
Conceptual Model of Health Related Quality of Life (HRQL)
Adapted from Wilson IB 1995
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Outcomes Research is relevant across the disease continuum
Prevention Detection Diagnosis Treatment Long Term
• Obesity diagnosis and management• Risk AssessmentCommunication/Counseling• Prevention
• ScreeningRecommendationsandPractices
• RiskAssessment(genetics)• TimelyDiagnosisand Referral
• End-of-LifeCare• Use ofEvidence-Based Therapies• PainManagement
• Follow-up Long term
Cross Cutting Topics• Access to Care• Health Disparities• Economics of Care• Quality of Care
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What studies are included in Outcomes Research?
• Studies of variations in medical practice patterns
• Studies of effectiveness of various treatments
• Appropriateness studies to determine circumstances when a procedure should/should not be performed
• development of tools to identify patient preferences
• measuring changes in health status
• measuring patient satisfaction with the health care process
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Measure Example
Mortality Infant death rate
Physiologic measures Blood pressure
Clinical events Stroke
Symptoms Difficulty breathing
Functional measures SF-36, a 36-item health survey
Patients' experiences with care
Consumer Assessment of Health Plans Survey
Examples of Health Outcomes
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Challenges to Conducting Outcomes Research
• Acceptance of outcomes research by clinicians
• Unique aspects of child health outcomes research
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Unique Aspects of Outcomes Research in Children
• Development
• Dependency
• Different epidemiology
• Demographic patterns
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Unique Aspects of Outcomes Research in Children
• Development
return to normal activities construct requires
unique approaches for infants, preschoolers and teens
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Unique Aspects of Outcomes Research in Children
• Dependency
– parent-child dyad complicates– health education, disease management and
access to health care
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Unique Aspects of Outcomes Research in Children
• Different epidemiology
– <5% of children affected by heart disease, diabetes and arthritis
– these are the conditions most frequently addressed in adult outcomes research
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Unique Aspects of Outcomes Research in Children
• Demographic patterns
– 1 in 5 children live in poverty– 15% are uninsured– 1 in 4 families headed by a single parent
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Who uses Outcomes Research?
• Clinicians
• Payers
• Administrators
• Policy makers
• Patients
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Where does the funding come from?
• Federal Grants – Agency for Health Care Policy and Research– NIH (Effectiveness studies)– Maternal Bureau of Child Health
• Private Foundations – Robert Wood Johnson– Pew Charitable Trusts– Kaiser Foundation
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Incorporating Results into Practice
• Publications and conferences• Educational interactive videos• Continuous Quality Improvement/Management
tools• Clinical Practice Guidelines• Clinical Pathways• Disease Management tools
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Summary
• Field of Outcomes Research broad and complex
• Studies all aspects of the health care process• Requires collaboration among physicians,
nurses, economists, sociologists, biostatisticians, epidemiologists, political scientists
• Rewards are great!
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