Dentistry and Clinical Practice Guidelines

To become familiar with the historical roots of the development of clinical guidelines

To learn link between development of guidelines and quality of care issues

To understand link between development of guidelines and evidence-based research

To become familiar with the notions, evidence hierarchy & hierarchy of studies

To consider what evidence-based dentistry (EBD) entails

Historical Perspective

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 & Account- ability - (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?

Quality of care
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
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”

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

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

"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 -
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

Growing focus on developing practice guidelines

based on outcomes research:

Medicine – 1980’s

Dentistry – 1990’s

Need to know “best” treatments

Need to reduce variation in use

only those so categorized would be reimbursed

thus reducing the amount of ineffective care & its costs

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

Evidence-based guidelines
Evidence hierarchy

Level 1 - Replicated clinical trials

Systematic replication of results from well-controlled, multiple, randomized controlled trials in which the outcomes are relatively homogenous

Meta-analyses

Meta-analytic studies of well-designed studies in which the literature review is comprehensive and the selection criteria are explicit

Evidence-based guidelines
Evidence hierarchy

Level 2 - Randomized clinical trial

Large multisite studies employing controls such as:

randomized sampling and assignment to conditions,

double-blind design,

and appropriate statistical analysis

Evidence-based guidelines
Hierarchy of Studies:Evidence-based value

Level 3 - Systematic, well-controlled, longitudinal studies with careful sampling

One or more well-conducted cohort studies

One of more well-conducted case-control studies

Evidence-based guidelines
Hierarchy of Studies:Evidence-based value

Level 4 - Randomized, non-controlled, studies

Surveys with random sampling (e.g., census)

Cross-sectional studies with careful random selection and clear exclusion rules

Evidence-based guidelines
Hierarchy of Studies:Evidence-based Value

Level 5 - Non-random, non-controlled

Dramatic uncontrolled field observations or experiments

Expert committees, task forces, professional reports

Lowest level of evidence base

Case studies

Editorial & articles in non-peer reviewed journals

Opinion pieces

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

Evidence-based dentistry

Practice in accordance with rules of scientific evidence...

Whenever possible, evaluate health care using controlled clinical trials...

Evidence-based dentistry

Taken in a narrow sense

suggests that randomized clinical trials qualify as “evidence” …

…that experiential knowledge acquired through experience and practice, however useful & usable, does not

Evidence-based dentistry

EBD - narrowest sense

Counterproductive? –

since intention of evidence-based is to bridge the gap between research and practice

EBD - broadest sense

includes both experiment and experience

Neither form of evidence is sufficient

both necessary for good clinical care

Evidence-based dentistry

Use of practice-based research networks (PBRNs) to collect data these studies

a network of practitioners

define research questions

record health and health care events

in relatively unselected patient populations

Evidence-based dentistry

Organized dentistry could provide the leadership

to form networks of private dental practices

to collect information on treatment effectiveness

in a scientifically valid and reliable manner

Evidence-based dentistry

Would allow DDS to systematically evaluate a particular procedure or condition of interest

provide results directly representative of and applicable to the daily practice of dentistry in the “field

Evidence-based dentistry

Challenge has been made:

“With the exception of dental sealants, the effectiveness, or average benefit of a procedure, when used by the average provider in the average community, of most common dental therapies has not been established”

Evidence-based dentistry

In the future, seven-fold ranges in tx costs (re Reader’s Digest)

hard to defend to payers and patients

Consensus on tx guidelines to reduce this variation will be elusive

until have a better understanding of tx outcomes


		To become familiar with the historical roots of the development of clinical guidelines
		To learn link between development of guidelines and quality of care issues
		To understand link between development of guidelines and evidence-based research
		To become familiar with the notions, evidence hierarchy & hierarchy of studies
		To consider what evidence-based dentistry (EBD) entails


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


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


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


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


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


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


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


	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


	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”


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


	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


	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


	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


	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


	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


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


	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


	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


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


	Growing focus on developing practice guidelines
	based on outcomes research:
		Medicine – 1980’s
		Dentistry – 1990’s
	Need to know “best” treatments
	Need to reduce variation in use
		only those so categorized would be reimbursed
		thus reducing the amount of ineffective care & its costs


	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


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


	Level 1 - Replicated clinical trials
		Systematic replication of results from well-controlled, multiple, randomized controlled trials in which the outcomes are relatively homogenous
		Meta-analyses
		Meta-analytic studies of well-designed studies in which the literature review is comprehensive and the selection criteria are explicit


	Level 2 - Randomized clinical trial
		Large multisite studies employing controls such as:
		randomized sampling and assignment to conditions,
		double-blind design,
		and appropriate statistical analysis


	Level 3 - Systematic, well-controlled, longitudinal studies with careful sampling
		One or more well-conducted cohort studies
		One of more well-conducted case-control studies


	Level 4 - Randomized, non-controlled, studies
		Surveys with random sampling (e.g., census)
		Cross-sectional studies with careful random selection and clear exclusion rules


	Level 5 - Non-random, non-controlled
	Dramatic uncontrolled field observations or experiments
	Expert committees, task forces, professional reports
	Lowest level of evidence base
		Case studies
		Editorial & articles in non-peer reviewed journals
		Opinion pieces


	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