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Health Care USA 1 Chapter 11
Research: How Health Care
Advances Health Care USA 2 CHAPTER OBJECTIVES
• Identify the foci of different types of research and
how each contributes to health and medicine
advances
• Understand the origins and applications of health
services research
• Describe functions of the Agency for Healthcare
Research & Quality
• Review research on quality of care and future
challenges
Health Care USA 3 Research Contributions to Medical
Advances
• Transition from dependence on
physicians’ clinical impressions and
anecdotal reports to statistically valid
findings from controlled studies Health Care USA 4 Research Interpretation: Challenges
• Volume of reports in popular media: difficult
interpretation, evaluation of potential human
applications
– Premature report of findings
– Sensationalism of minor scientific advances
– Fraud Health Care USA 5 Focus of Types of Research
• Disciplinary: Theory
• Biomedical: Organisms
• Clinical: Persons
• Health services: Systems
• Public health: Communities Health Care USA 6 Basic Science Research
• Biochemists, physiologists, geneticists,
pharmacologists
– Much at cellular level
– Antecedent to clinical advances
– Understanding of growth, development,
structures and functions of human body and
response to stimuli Health Care USA 7 Clinical Research
• Focus on steps in medical care process:
diagnosis, treatment, rehabilitation, palliation
– Much is experimental using controlled clinical
trials
– Conducted by all major disciplines: medicine,
nursing, health related professions Health Care USA 8 Clinical Trials
• Test new treatments, drugs, medical devices
against prevailing standard of care
– May use control groups to minimize subject bias
• Random selection of treatment & control group
members further reduces bias
• Double-blinded, placebo controls are most
rigorous Health Care USA 9 Safeguards Protecting Volunteer
Subjects
• Peer review committees to judge scientific
merit
• Institutional Review Boards review ethical
considerations
• Informed consents detail: potential risks, side
effects, expected benefits Health Care USA 10 Epidemiology (1)
• Epidemiology (population) research: distribution
& determinants of health, diseases, injuries in
human populations. Much is observational
(descriptive or analytical):
– Collects information about natural phenomena,
characteristics, behaviors of people, peoples’
locations & environments, exposures to
circumstances or events Health Care USA 11 Epidemiology (2)
• Descriptive Studies
– Use patient records, interview surveys, databases,
other information to identify factors determining
distribution of health and disease among specific
populations
– Relatively fast, inexpensive; may suggest
hypotheses or raise questions for future study Health Care USA 12 Epidemiology (3)
• Analytic Studies
– Under naturally occurring conditions, to observe
differences between two or more populations with
different characteristics or behaviors
– Try to explain biologic phenomena by statistical
association between factors that may contribute to
a subsequent occurrence Health Care USA 13 Epidemiology (4)
• Analytic Studies Examples
– Data about smokers and non-smokers to determine
relative risk of an outcome such as lung cancer
– Cohort studies such as Framingham follow a
cohort to determine associations among variables
such as diet, weight, exercise and other behaviors
related to heart disease and other outcomes Health Care USA 14 Experimental Epidemiology
• Investigator actively intervenes by
manipulating one variable to observe effect on
other; control populations ensure that other,
non-experimental variables do not affect
outcomes.
– Technically difficult
– Ethical concerns: unknown risks; withholding
potentially beneficial drug or treatment among
controls
Health Care USA 15 Other Applications of Epidemiological
Methods
• Health services planning, administration and
evaluation
• Forecasting population group health needs
• Assess adequacy of health personnel supply
• Determine outcomes of specific treatments in
clinical settings Health Care USA 16 Health Services Research (1)
• Arose from need to improve efficiency,
effectiveness of health care & determine which
treatment options produce best outcomes for
specific conditions
• Uses perspectives & methods of epidemiology,
sociology, economics, clinical medicine Health Care USA 17 Health Services Research (2)
• Agency for Health Care Policy & Research
(AHCPR): est. 1989 in US Public Health
Service, Department of HHS
• Response to Wennberg studies on clinical
variations; promotes development of clinically
relevant guidelines to assist health care
practitioners in prevention, diagnosis,
treatment
Health Care USA 18 Agency for Healthcare Policy and
Research, 1989-1996
• Medical Treatment Effectiveness Program:
– identified and analyzed patient outcomes
associated with alternative practice patterns and
recommended changes through patient outcomes
research teams & literature synthesis projects
(meta-analyses)
• Forum for Quality & Effectiveness
– development & review of practice
recommendations Health Care USA 19 Surgeons’ Backlash
• Back surgery guidelines suggesting
ineffectiveness compared with conservative
interventions
– Surgeons’ organizations lobbied Congress on
AHCPR exceeding authority
– AHCPR withdrew from producing clinical
guidelines; instead, produce research to aid
medical specialties with guideline development Health Care USA 20 Healthcare Research & Quality Act of
1999
• Renamed AHCPR to Agency for Healthcare
Research & Quality (AHRQ); Mission:
– Improve outcomes & quality of health care
services
– Reduce costs
– Address patient safety
– Increase service effectiveness through scientific
research that promotes clinical & systems
improvements
Health Care USA 21 AHRQ Today
• Top priority: providing research findings &
new health information to consumers
– Many consumer-oriented publications
– User-friendly, internet access
– Strong congressional and presidential
support emanate from medical errors &
quality concerns
Health Care USA 22 Health Services Research
• Combines perspectives & methods of
epidemiology, sociology, economics & clinical
medicine
• Uses process & outcome measures reflecting
behavioral and economic variables associated
with therapeutic effectiveness and cost benefit Health Care USA 23 Health Services Research Contributions to
Health Policy (1)
• Wennberg studies of small area variation in
medical utilization
• Prospective payment based on DRGs
• Research on inappropriate medical procedures
• Resource-based MD payments
• Concepts of HMOs and managed care Health Care USA 24 Health Services Research
Contributions to Health Policy (2)
• RAND Health Insurance Experiment:
compared costs & health outcomes of families
in fee-for-service & prepaid health plans
• Health Services Utilization Study
• Medical Outcomes Study Health Care USA 25 Quality Improvement
• Historically, belief that only physicians can judge
quality of other physicians’ work
– Clinical judgment left to individual knowledge
and intuition (implicit criteria)
– “Bad Apple” theory…weeding out the worst
practitioners to solve quality problems; focus on
isolated violations of practice standards
– Quality = absence of mishap Health Care USA 26 Avedis Donabedian
• 1966: Health care = structure, process,
outcome
– Structure: provider numbers, types, skills, physical
facilities and equipment
– Process: diagnostic, treatment & patient
management activities
– Outcome: Patient results as assessed by providers Health Care USA 27 Implicit vs. Explicit Quality Criteria
• Implicit: judgments of individual
reviewers based on personally-derived
criteria applied in review process; strong
bias
• Explicit: externally developed in advance
by independent experts; less bias Health Care USA 28 Empirical Quality Standards (1)
• Derived from distributions, averages, ranges &
other measures of data variability; compare
data collected from many similar health
service providers to identify practices
deviating from the norm
– E.g., patient severity-adjusted, hospital & provider
performance data to measure & compare process
activities & patient outcomes that deviate from
norms
Health Care USA 29 Empirical Quality Standards (2)
• Examples
– Patient severity adjusted hospital performance data
to measure & compare process and outcomes,
“report cards,” e.g. Medicare’s Hospital Compare.”
– Patient severity adjusted physician performance
data to measure & compare outcomes for specific
physicians, e.g Cardiovascular surgery “report
cards.” Health Care USA 30 Empirical Measures of Quality
• Examples
– Timeliness of ambulation
– Compliance with basic nursing care standards
– Number of home care referrals
– Timeliness of orders and results
– Medication errors
– Readmissions within 30 days post-discharge
– Peri-operative mortalities
Health Care USA 31 Medical Errors (1)
• 1990 Institute of Medicine (IOM) Report:
– Widespread overuse of expensive, invasive
technology
– Under-use of inexpensive “caring” services
– Error-prone procedures that harm patients &
waste resources Health Care USA 32 Medical Errors (2)
• 1999 IOM Report ( To Err is Human)
– Medical errors during hospitalization one of
nation’s leading causes of death, disability
(44,000-98,000 deaths/year)
– Health Care Quality Improvement Act of 1999
designated the AHRQ to establish national
safety goals, track progress & invest in research
about error prevention Health Care USA 33 Evidence-based Medicine (1)
• “Systematic application of best available
evidence to evaluate options & decisions in
clinical practice & management.”
• Variability in clinical practice, test complexity,
difficulty in staying current, suggest many
clinical decisions not supported by evidence of
effectiveness Health Care USA 34 Evidence-based Medicine (2)
“The acid test is whether services, programs
and policies improve health beyond what could
be achieved with the same resources by
different means, or by doing nothing at all.
Evidence is the key to accountability;
decisions of providers, administrators, policymakers, patients, public need to be based on
appropriate, balanced, high quality
evidence.”…Thomas Chalmers, Harvard School of
Public Health
Health Care USA 35 Evidence-based Medicine (3)
• Most investigations reported in peer-reviewed
journals are preliminary tests of innovations…
serve science, rather than guiding practitioners
with practical advice
• Now, cost-control pressures to ensure therapies
have patient benefit, growing general interest in
care quality, increased patient knowledge are
stimulating acceptance of evidence-based
approach Health Care USA 36 Outcomes Research (1)
• Evaluates health care results in real world
of medical offices, hospitals, clinics,
homes
• Contrasts with studies of treatments in
controlled environments Health Care USA 37 Outcomes Research (2)
• Questions whether effects of treatment on
health, well-being of patients, population,
justify costs
• Insurers, government, employers, consumers
seek outcomes information to make better
decisions Health Care USA 38 Outcomes Research (3)
• Traditionally, outcomes were measured
physiologically: lab tests, complication
rates, recovery & survival rates Health Care USA 39 Outcomes Research (4)
• Outcomes research defines health status in
measures of patient functional status, well-being,
satisfaction with care:
– Physical functioning
– Role functioning: health interference with
activity
– Social functioning: health effects on normal
social activities Health Care USA 40 Patient Satisfaction
• Patient perceptions, though often different from
providers’, constitute important quality
component in a competitive market environment
• Many types of patient satisfaction survey
instruments in use (Picker Institute, etc.); phone
surveys, mail, interviews; contribute to service
improvement & marketing Health Care USA 41 Research Ethics
• Research priorities focus on remedial strategies
for those currently affected by diseases, not
preventive strategies
• Historically, research funding priorities focus on
epidemics, e.g. polio (1940s), HIV/AIDS (1990s),
H1N1 (2009)
• Failure to fund tax-payer-supported medical
research to benefit not only remedial medical
practice, but also community at large Health Care USA 42 Conflicts of Interest in Research (1)
• Increasing numbers of studies on new drugs &
devices shifting from academic institutions to
commercial firms
• Pharmaceutical companies paying researchers to
design & interpret drug trials accused of
misrepresenting/suppressing unfavorable results Health Care USA 43 Conflicts of Interest in Research (2)
• Under pharmaceutical lobbying pressures,
FDA straying from science-based, public
health mandate by shifting funding from
government to pharmaceutical firms it is
charged with monitoring Health Care USA 44 Conflicts of Interest in Research (3)
• Examples
– 2009: NJ Attorney General subpoened 5 major
medical device makers for failing to disclose
financial conflicts of interest among physicians
researching their products; physicians were
compensated with company stock
– Physicians attach their names to “ghostwritten”
articles by pharmaceutical company employees Health Care USA 45 Conflicts of Interest in Research (4)
• FDA position on “trade secrets” that withhold
full reports on drug safety & efficacy
• NIH suggests that involved universities, not
government should address the ethical
situations…researcher disclosure requirements
are proceeding. Health Care USA 46 Future Challenges (1)
• U.S. health care research historically directed
toward a “complaint/response” system
• Managed care influence has shifted many
research priorities shifting from individuals to
populations with prevention focus Health Care USA 47 Future Challenges (2)
• Basic science advancement in diagnostic and
therapeutic efficacy will produce new ethical, legal
and clinical issues:
– Genomics will reshape biology and medicine,
leading to diagnostic & treatment
improvements, unprecedented clinician &
patient decisions
– Life-prolonging & transplantation technology
will make patient & clinical choices much more
complex
Health Care USA 48 Future Challenges (3)
• The “post-antibiotic” era
– Specific bacterial infections increasingly
unresponsive to exiting drugs
– New anti-microbial agents failing to keep pace
– Bacterial genetics engineering must be
supported to address antibiotic resistance Health Care USA 49 Future Challenges (4)
• Public health research should receive higher
priority and political support:
– To foster a population perspective
– To better understand and close the gap between
existing health services and responsive
provider/consumer behaviors
– To identify a clear, consistent national strategy for
potential public health disasters Health Care USA 50