Historical Perspective on the Health Care System

	Three Eras
	I.   Expansion
	II.  Cost Containment
	III.  Assessment & Accountability

Era of Expansion (40’s -60’s)

	Health care system grew quickly
		More hospitals
		More private insurance coverage
		Numbers of clinicians increased
		Advances in technology and science

Era of Cost Containment
 (1965 - 80s)

	Focus on efforts to curb cost growth
		Prior approval      Second opinions
		Utilization reviews      Prospective payment
		Managed care - HMOs, PPOs, independent practitioner associations

Era of Assessment &  Accountability - (late 80s - present)

	Focus broadened -
	Not only cost, but quality of care
		Patients, employers, government increasingly requested information
		about the value of resources spent on health care

Quality of care

	Most widely accepted view - three dimensions:
		structure - characteristics of the settings in which care is provided
		process - actions taken on behalf of patients, or by patients
		outcome - the effects of care

Quality of care
Dimensions

	Structure  - the settings and resources used for health care
			facilities
			equipment
			personnel qualifications and experience
			staffing patterns
			organizational arrangements

Quality of care
Dimensions

	Process
		the content/act of care
			how the patient moves into…
			through…
			out of…the health care system
		the services provided during the episode

Quality of care
Dimensions

	Outcome
		the results/effect of care
			did the patient get better?
			was morbidity reduced?
			was mortality reduced?

“Outcomes” and “effectiveness”  (1990’s)

	Bywords of 1990s efforts
	Produced by several means
		Clinical trials
		Insurance claims databases
		Meta-analyses

Goals for outcomes research

	Reduce unnecessary use of procedures/modalities of care.
			assume that outcomes research can determine what is unnecessary and that these determinations can be applied in individual cases
			assume that research is value-free
	Improve quality of care.
			Problem here is the definition and measurement of quality and who defines quality.

Goals for outcomes research

	Reduce cost
			Cost probably the driving force for outcomes research (but outcomes research could produce either cost-reducing or cost-enhancing results).
			Rationale behind cost-reducing assumption is that there is inappropriate use of technology and use of ineffective technology
	Provide information for provider/patient decision making
			Probably most feasible goal for outcomes research
			Assumes clarity/widespread diffusion of findings

Health Technology Assessment

	An old but evolving science and art
	In a way has been around forever
		Observation, trial and error of the clinician
	What characterizes more recent efforts:
			translating findings into
			“best” practices at the provider/patient    level
			(practice guidelines)

Health Technology Assessment

	Designed to provide clinicians with information on the probability that the drug, device, or procedure is:
	safe and works
	improves the patient’s condition
		saves lives
		Reduces/cures disease
		reduces disability
		improves quality of life

Tradition of Health Technology Assessment - Before the 1970’s (cont.)

	Formalized assessments of safety and efficacy began in the US
	Food and Drug legislation in 1923
	Creation of the National Institutes of Health (NIH) in 1931
	Expansion of federal biomedical research funding after WWII – 1940s
		Large-scale, decades-long clinical trails of new treatments for prevalent illnesses

Tradition of Health Technology Assessment - the 1970’s (cont.)

	Major health care issue
		in the 1970’s defined as escalating costs
		particularly under Medicare
	Major belief:
		that technological advances played a major role in health care inflation
	Congress, private payers, economists sought to
		identify causes of/find acceptable solutions to health care inflation

Tradition of Health Technology Assessment - the 1970’s (cont)

	“There is an emerging consensus that many technologies have been widely adopted into medical practice in the face of disturbingly scanty information about
	their health benefits,
	clinical risks,
	cost effectiveness
	and social side effects”
		– 1978 Congressional hearings

Tradition of Health Technology Assessment - the 1970’s (cont)

	In 1972, Congress established the Office of Technology Assessment as an analytic arm of Congress.
	In 1976, the NIH initiated consensus conferences
		synthesize information, bring judgment of professionals and nonprofessionals to bear on technology assessment issues

Tradition of Health Technology Assessment - the 1970’s (cont)

	Technology assessment gained important public recognition in 1978
	Congress established the National Center for Health Care Technology (NCHCT)
		To advise Medicare on coverage
		set priorities for technology assessment
		convene and conduct assessments
		disseminate findings of technology assessment

Tradition of Health Technology Assessment - the 1970’s (cont)

	Agency for Health Care Policy and Research (AHCPR) now AHRQ (Agency for Healthcare Res and Quality)
		took on sponsorship of outcomes research and practice guidelines
		conduct large-scale studies of the effectiveness of specific medical technologies
		AHRQ oversees the development of practice guidelines

Tradition of Health Technology Assessment - the 1970’s - Private sector responses

	Both the AMA and the Health Industry Manufacturers Association
		opposed to the creation/activities of the NCHCT
	Employers and insurers
		began to look to technology assessment for help in constraining costs

Tradition of Health Technology Assessment - the 1970’s - Private sector responses

	Specialty societies, most notably American College of Physicians, undertook studies
	When NCHCT disbanded in 1982
		other quasi-public efforts made by the IOM (Institute of Medicine)
		and the National Academies of Science to maintain a focus on technology assessment

Tradition of Health Technology Assessment - the 1970’s - Private sector responses

	Clinicians and health services researchers at universities and research centers
	the RAND Corporation and others
		turned their attention to what has come to be called outcomes research
	including studies of variation in patterns of medical practice

Tradition of Health Technology Assessment - the 1970’s – Private/public sector responses

	Other forms of technology assessment were being developed
		Meta-analyses, a sophisticated statistical technique, is being used to combine findings of multiple clinical trials
		Quality of life measures were developed as a substitute for economic measures
			Particularly relevant for dentistry

Quality of care
Variation in use issues

	How to know which procedures were “best”?
	Examined process (procedures)
		In the 60’s, in medicine
		as way to learn about treatment appropriateness
	Found considerable variation
		in the utilization rates of surgical procedures
		within small, similar geographic areas

Quality of care
Variation in use issues

	Variation in use
	Most commonly refers to:
		different observed levels of per capita consumption of a service
		when all the usual explanations have been   controlled
	leaving no obvious explanation except “practice style”

Variation in use – a historical perspective

	Originate in the phenomenon of practice pattern variations described by Wennberg and his associates in a continuing series of studies starting in the mid 70’s
		These papers demonstrated substantial geographical variation in the aggregate use of physician and hospital services
		And in specific utilization rates of common surgical and radiologic procedures
		The authors argued that these variations neither reflect an intrinsic variation in the prevalence of specific conditions, nor are explained by differing patient preferences,
	What they do represent is still a matter of considerable debate
	Nevertheless appears to be general agreement that such variations are a symptom of something seriously wrong with our health system
		Which should either be addressed for its own sake or as a way of controlling health care costs

Quality of care
Issues

	Implications of variation in use
	Can result in:
		under- and over- utilization
	With cost implications
	With health implications

Quality of care
Issues

	Need to know “best” treatments
		only those so categorized would be reimbursed,
		thus reducing the amount of ineffective care & its costs
	Led to development of practice guidelines

"Congress began to look to..."

	Congress began to look to outcomes research
		as a means of evaluating medical/dental treatment
		as a sound source for the development of practice guidelines

Evidence-based guidelines -
Types of evidence

	Efficacy  - Does the agent “work” under  ideal, “laboratory” conditions?
	Often studied with the randomized clinical trial
	conducted in highly controlled settings
	often expensive
	may present ethical constraints
	may not reflect the outcomes obtained when used in a typical practice setting

Evidence-based guidelines -
Types of evidence

	Effectiveness - Does the agent work under ordinary “real life” conditions , i.e., the average DDS for the typical patient?
	Often studied with clinically-based/ practice-based research designs
	Examine average providers providing care in average clinical situations

Evidence-based guidelines -
Outcomes research
Dimensions of oral health outcomes

	Drs. Jim Bader & Dan Shugars described four dimensions of oral health outcomes:
	1.  Physical and physiological dimension-
		pathology (dental caries, periodontal disease, oral cancer, periapical infection, etc.), pain, & functional capacity

Evidence-based guidelines -
Outcomes research
Dimensions of oral health outcomes

	2.  Psychosocial outcomes of dental care
			aesthetics
			level of perceived oral health
			satisfaction with oral status
			self-concept
			interpersonal relations
		Measured by asking patients about their experience, perceptions

Evidence-based guidelines -
Outcomes research
Dimensions of oral health outcomes

	3.  Longevity and survival of dental restorations, tooth vitality, tooth retention
		reflects the survival of dental restorations
		time until restoration failure
		need for subsequent treatment for same condition

Evidence-based guidelines -
Outcomes research
Dimensions of oral health outcomes

	4.  Economic dimension
		Assess the direct and indirect costs
		From the patient’s, practitioner’s, purchaser’s, and society’s perspective
	Cost of dental care
		can be an important patient outcome

Evidence-based guidelines -
Outcomes research

	Summarizing -
	examines the clinical, functional results of a therapeutic intervention
	as well as the patient’s perceptions of outcome & quality of life

Evidence-based guidelines -
Need for evidence

	Discovered lack of evidence
		Almost no studies of efficacy
		Almost no studies of effectiveness
		Many guidelines the product of expert opinion
	Patients’ perceptions of outcomes of treatments
		Little known
	Overall:
		Had paucity of information
		Had ever-increasing health care expenditures

Evidence-based guidelines -
Need for evidence

	In 1989 Congress established the agency for Health Care Policy and Research (ACHPR)
	In 1999, became AHRQ – Agency for Healthcare Research and Quality
		to support studies designed to:
			reduce variation in tx selection
			to assess efficacy/effectiveness of care
			to support studies designed to develop
			program/ clinical guidelines

Quality/Hierarchy of Evidence
(Guide to Clinical Preventive Services, 2^nd ed.)

	I: Evidence from at least 1 properly random- ized controlled trial
	II-1: …from well-designed controlled trials w/o randomization
	II-2: …from well-designed cohort or case-control analytic studies from >1 research grp
	II-3: …from multiple time series w/ or w/o the intervention (dramatic results, e.g., penicillin)
	III:  Experts, experience, case reports

Strength of Recommendations

	A: Good evidence to support the rec that condition be considered in periodic hlth exam
	B: Fair evidence to support rec that be specifically considered
	C: Insufficient evidence to rec for or against the inclusion of the condition, but rec may be made on other grounds
	D: Fair evidence to support the rec that be excluded
	E: Good evidence to support the rec that be
	excluded

Focus on 7 particular worries

	Biased and defective methodology
	Unwarranted inferences drawn from the data
	Patient preferences
	Clinical experience
	Unobservable benefits and harms
	Legal liability
	Additional tacit motivations

Biased and defective methodology

	Skepticism about the authority behind the outcomes data or practice guidelines
		E.g., megatrials vs. administrative databases
	Methodological objections
		the reliability of the sample used
		Carelessly organized randomized clinical trials
		Mistakenly drawn conclusions from the data
	Need to ensure the consistency and integrity of the guideline development process

Hidden values

	Charge is made that outcomes data and guidelines reflect hidden, unacknowledged values
	In the course of low birth weight babies,
		One study assessed survivability as a good outcome
		Others considered only survival without devastating neurological deficits to be a good result
	Such difference reflect the different values of the researchers
	The clinician brings his/her own set of values, as well

Patient preferences

	Many clinicians cite patient preferences as a reason not to abide by recommendations for action associated with outcomes data
	What if data predict that an intervention will be no more effective than doing nothing
		but clinicians believe patient  preferences for an action provide an overriding justification for intervening anyway
	What if some clinicians believe findings that an intervention will have an effect and agree with the finding’s recommendations for action
		nevertheless do not proceed when faced with patient resistance,

Clinical experience

	Some clinicians – especially those with years of experience  - frequently do not directly dispute the reliability and validity of outcomes data
		But still resist the associated recommendations – citing the superiority of their own clinical experience and knowledge
	A reflection of the claim of dentistry/medicine as art over science
		That there is a difference between statistical outcomes in general for a class of patients and what might be effective with a particular patient

Doctrine of Individuality

	As long as clinicians have focused upon the treatment of disease as the “great end of all our studies”
	Has been recognized that an essential characteristic of medical therapy was that to be conscientious, it could not be routine
		Two reasons for this:
		Because the expression of disease varied not only with the nature of the disease by also with the nature of the patient,
		And because all drugs had many different actions, the risks of the side effects of a drug in a given patient might vary with the patient’s temperament and constitution

Doctrine of Individuality

	At the core of this perspective is the concept that care of the patient must be individualized
		No two patients ever have exactly the same disorder
	Therefore proper treatment must be based not only on the specific or “constant” features of the patient’s disease
			But also on a range of personal characteristics that distinguish one patient from another…
		And one patient’s personal disorder from another’s

Doctrine of individuality

	This was not to deny any systematic relationship between a patient’s illness and its proper treatment
		but rather, to insist that treatment could not be mechanically chosen without attention to a wide range of characteristics
		of which the physician would be aware as part of the patient’s personal or family history
		or that would be recognized as the disease expressed itself in the particular patient
	A commitment to the principle of “therapeutic specificity”

Unobservable benefits and harms

	That the data answered some questions, but not their questions –
		Consequently the data were less significant to their practice
	With technologies where clinicians can not directly observe the harm of not intervening
		Or the benefits of intervention
		(where there is a time gap between the intervention and observable effects)
		Or clinicians do not sense an immediate great risk to the patient

Fear of liability

	Clinicians commonly perceive threats of legal liability for either following or not following guideline recommendations
		Feel that they can be sued for following too rigidly the outcomes research recommendations
		Is unclear whether, and to what extent, clinicians will be held liable for following or not following outcomes data and associated practice guidelines
	Dangerous to allow fear of liability to paralyze the outcomes movement, especially when some outcomes data demonstrate that some clinical practice is harmful to patients

Tacit motivation and unarticulated resistance

	Fellow clinicians leveled charges against each other – that their colleagues’ stated reasons for a resisting outcomes data and guidelines should not be believed – that their real reasons were:
		Profit
		Ego
		Ignorance
	Some of the objections offered seem to be rationalizations
	Also have local pressures, mores, and social dynamics
		Age is felt to be a factor
		Economic motivation is felt to be a factor