Evidence-based Medicine as a Patient Safety ToolKey Concepts, Emerging Applications

EvidenceEvidence--based Medicine as a Patient Safety based Medicine as a Patient Safety ToolToolKey Concepts, Emerging ApplicationsKey Concepts, Emerging Applications

The Quality Colloquium at Harvard UniversityBoston, Massachusetts

Paul H. Keckley, Ph.D.Vanderbilt Medical Center

August 20, 2006

The Quality Colloquium at Harvard UniversityBoston, Massachusetts

Paul H. Keckley, Ph.D.Vanderbilt Medical Center

August 20, 2006

What we’ll coverWhat we’ll coverWhat we’ll cover

The momentum for safety

EBM as a means to an end

Implications for provider organizations

BIOTECHBIOTECH

INNOVATORSINNOVATORS

ADMINISTRATORS/WATCHDOGSADMINISTRATORS/WATCHDOGS

SERVICE PROVIDERSSERVICE PROVIDERS

PhysiciansPhysicians

HCITHCIT

PharmaPharma

DeviceDevice

HospitalsHospitalsOutpatientFacilities

OutpatientFacilities

InsurersInsurers

RegulatorsRegulators

Long TermCare

Long TermCare

BioTechBioTech

ProfessionalSocieties/

Special Interests

ProfessionalSocieties/

Special Interests

Accrediting Agencies

Accrediting Agencies

DiseaseManagement

DiseaseManagement

EmployersEmployers

CAMCAM

MediaMedia

AcademicMedicine

AcademicMedicine

CONSUMERSCONSUMERS

Allied HealthProfessionalsAllied HealthProfessionals

$1.9 Trillion

$1.3 Trillion

$696 Billion

$246 Billion

0.0

0.5

1.0

1.5

2.0

1980 1990 2000 2005(Projected)

$ T

rilli

ons

8.8% GDP

8.8% GDP

12.0% GDP

12.0% GDP

13.3%GDP

13.3%GDP

15.7%GDP

(projected)

15.7%GDP

(projected)

$6320 per person in the U.S.!$6320 per person in the U.S.!$6320 per person in the U.S.!

“The quality of care we get is far from the care we should be getting” — Don Berwick, IHI“The quality of care we get is far from the care “The quality of care we get is far from the care we should be getting” we should be getting” —— Don Berwick, IHIDon Berwick, IHI

Preventive care deficiencies•Child immunizations 76%•Influenza vaccine 52%•Pap smear 82%

Preventive care deficiencies•Child immunizations 76%•Influenza vaccine 52%•Pap smear 82%

Acute care deficiencies•Antibiotic misuse 30-70%•Prenatal care 74%

Acute care deficiencies•Antibiotic misuse 30-70%•Prenatal care 74%

Chronic care deficiencies•Beta blockers 50%•Diabetes eye exam 53%

Chronic care deficiencies•Beta blockers 50%•Diabetes eye exam 53%

Hospital care deficiencies•Proper CHF care 50%•Preventable deaths 14%•Preventable ADEs 1.8/100 admits

Life threatening 20%Serious 43%

Hospital care deficiencies•Proper CHF care 50%•Preventable deaths 14%•Preventable ADEs 1.8/100 admits

Life threatening 20%Serious 43%

“Quality of Care”Safe

EffectivePatient-centered

TimelyEfficient

Equitable

“Quality of Care”“Quality of Care”Safe

EffectivePatient-centered

TimelyEfficient

Equitable

Surgery care deficiencies•Inappropriatehysterectomy 16%

•InappropriateCABG surgeries 14%

Surgery care deficiencies•Inappropriatehysterectomy 16%

•InappropriateCABG surgeries 14%

What the evidence says is what you get (half the time)What the evidence says is what you get What the evidence says is what you get (half the time)(half the time)

53.9Colorectal cancer

57.3Osteoarthritis

57.2Orthopedic conditions

57.7Depression

58.0Chronic obstructive pulmonary disease

59.1Cerebrovascular disease

63.9Congestive heart failure

64.7Hypertension

68.0Coronary artery disease

68.5Low back pain

73.0Prenatal Care

75.7Breast cancer

78.7Senile Cataract

% Recommended Care Received

Condition% Recommended Care

ReceivedCondition

10.5Alcohol dependence

22.7Hip fracture

24.7Atrial fibrillation

32.7Dyspepsia/peptic ulcer disease

36.7Sexually transmitted diseases

39.0Community acquired pneumonia

40.7Urinary tract infection

45.2Headache

45.4Diabetes mellitus

48.6Hyperlipidemia

53.0Benign prostatic hyperplasia

53.5Asthma

McGlynn et al “The Quality of Health Care Delivered to Adults in the United States” NEJM June 26, 2003McGlynnMcGlynn et al “The Quality of Health Care Delivered to Adults in the Unet al “The Quality of Health Care Delivered to Adults in the United States” NEJM June 26, 2003ited States” NEJM June 26, 2003

First

Third

FourthSource: S.F. Jencks, E.D. Huff, and T. Cuerdon, “Change in the Quality of Care Delivered to Medicare Beneficiaries, 1998–1999 to 2000–2001,” Journal of the American Medical Association 289, no. 3 (Jan. 15, 2003): 305–312.

Second

WA

ORID

MT ND

WY

NV

CAUT

AZ NM

KS

NE

MN

MO

WI

TX

IA

IL IN

AR

LA

AL

SC

TNNC

KY

FL

VA

OH

MI

WV

PA

NY

AK

MD

MEVT

NH

MARI

CT

DE

DCCO

GAMS

OK

NJ

SD

Quartile Rank

Note: State ranking based on 22 Medicare performance measures.Note: State ranking based on 22 Medicare performance measures.

Quality depends on where you liveQuality depends on where you liveQuality depends on where you live

Errors aboundErrors aboundErrors abound

1. Adverse drug events (ADEs, ADRs)

2. Iatrogenic infections• Post-operative deep wound infections

• Urinary tract infections (UTI)

• Lower respiratory infections (pneumonia or bronchitis)

• Bacteremias and septicemias

3. Decubitus ulcers

4. Mechanical device failures

5. Complications of central and peripheral venous lines

6. Deep venous thrombosis (DVT) / pulmonary embolism (PE)

7. Strength, agility and cognition

8. Blood product transfusion

9. Patient transitions

1. Adverse drug events (ADEs, ADRs)

2. Iatrogenic infections• Post-operative deep wound infections

• Urinary tract infections (UTI)

• Lower respiratory infections (pneumonia or bronchitis)

• Bacteremias and septicemias

3. Decubitus ulcers

4. Mechanical device failures

5. Complications of central and peripheral venous lines

6. Deep venous thrombosis (DVT) / pulmonary embolism (PE)

7. Strength, agility and cognition

8. Blood product transfusion

9. Patient transitions

80% of ADE’s avoidable80% of 80% of ADE’sADE’s avoidableavoidable

80.3Totalpreventable

YesFailure to adjust for known hematologic4.6

PhysioHernal

YesError in dosage on order5.0OrderDosage

YesFailure to adjust for patient body mass5.7

PhysioWeight

YesFailure to adjust for patient age14.2PhysioAge

YesFailure to adjust for decreasedRenal function

23.0PhysioRenal

YesKnow drug reactions28.0PharmExpected

Avoidable?Description%Class

Study: Health Care Costs, Error Rates Higher in U.S. Than in Other CountriesStudy: Health Care Costs, Error Rates Higher Study: Health Care Costs, Error Rates Higher in U.S. Than in Other Countriesin U.S. Than in Other Countries

November 04, 2005

For the report, researchers surveyed 6,957 adults between March and June 2005 who recently had been hospitalized, had surgery or reported health problems in the U.S., Australia, Canada, Britain, New Zealand and Germany. The survey, which is the largest to examine health care in several nations during the same time period, found that U.S. residents were more likely than patients in other nations to forego medical care because of costs. In addition, U.S. respondents reported the easiest access to specialists but the most difficulty getting care during nights and weekends (Washington Post, 11/4). Patients from all six countries reported medical errors, uncoordinated care and poor management of chronic diseases (CQ HealthBeat, 11/3).

The study also found the following:

34% of U.S. patients surveyed reported getting the wrong medication or dose, incorrect test results, a mistake in their treatment or late notification of abnormal test results, compared with 30% of Canadians, 27% of Australians, 25% of New Zealanders, 23% of Germans and 22% of Britons;

About half of U.S. residents reported that they had decided not to fill a prescription, see a physician when sick or have recommended follow-up tests because of costs, compared with 38% of patients in New Zealand, 34% in Australia, 28% in Germany, 26% in Canada and 13% in Britain;

Nearly one-third of U.S. patients reported paying more than $1,000 in out-of-pocket medical expenses in the past year, compared with 14% of Canadian and Australian patients and a much lower proportion of patients in the other countries (Washington Post, 11/4);

7% of U.S. residents who had been hospitalized in the past two years reported developing an infection while in the hospital, compared with 10% of Britons and 3% of Germans

November 04, 2005

For the report, researchers surveyed 6,957 adults between March and June 2005 who recently had been hospitalized, had surgery or reported health problems in the U.S., Australia, Canada, Britain, New Zealand and Germany. The survey, which is the largest to examine health care in several nations during the same time period, found that U.S. residents were more likely than patients in other nations to forego medical care because of costs. In addition, U.S. respondents reported the easiest access to specialists but the most difficulty getting care during nights and weekends (Washington Post, 11/4). Patients from all six countries reported medical errors, uncoordinated care and poor management of chronic diseases (CQ HealthBeat, 11/3).

The study also found the following:

34% of U.S. patients surveyed reported getting the wrong medication or dose, incorrect test results, a mistake in their treatment or late notification of abnormal test results, compared with 30% of Canadians, 27% of Australians, 25% of New Zealanders, 23% of Germans and 22% of Britons;

About half of U.S. residents reported that they had decided not to fill a prescription, see a physician when sick or have recommended follow-up tests because of costs, compared with 38% of patients in New Zealand, 34% in Australia, 28% in Germany, 26% in Canada and 13% in Britain;

Nearly one-third of U.S. patients reported paying more than $1,000 in out-of-pocket medical expenses in the past year, compared with 14% of Canadian and Australian patients and a much lower proportion of patients in the other countries (Washington Post, 11/4);

7% of U.S. residents who had been hospitalized in the past two years reported developing an infection while in the hospital, compared with 10% of Britons and 3% of Germans

Lack of capital and resources

Lack of capital and resources

Explosion in clinical knowledge

Explosion in clinical knowledge

Lack of political will,

leadership

Lack of political will,

leadership

Lack of consumer

involvement

Lack of consumer

involvement

Lack of appropriate technology

Lack of appropriate technology

Lack of trust among Key

Players

Lack of trust among Key

Players

Lack of incentives for

right behaviors

Lack of incentives for

right behaviors

RunawayCosts

RunawayCosts

Lack of Access

Lack of Access

InconsistentQuality

InconsistentQuality

The system is in meltdown..The system is in meltdown..The system is in meltdown..

“Quality” is our number one concern!!“Quality” is our number one concern!!“Quality” is our number one concern!!

Evidence Based Care

Patient Centered Approach

System Orientation

Evidence Based Care

Patient Centered Approach

System Orientation

To most, quality means safe, accessible careTo most, quality means safe, accessible To most, quality means safe, accessible carecare

Clinical Processes

•Adherence to evidence-based pathways in the diagnosis and intervention planning with patients

•Safe, effective, timely, patient-centered care•Collaborative care management

Clinical ProcessesClinical Processes

•Adherence to evidence-based pathways in the diagnosis and intervention planning with patients

•Safe, effective, timely, patient-centered care•Collaborative care management

Structural Processes

•Access to needed services in appropriate settings•Paperwork/administrative procedures to access services

and document transactions

Structural ProcessesStructural Processes

•Access to needed services in appropriate settings•Paperwork/administrative procedures to access services

and document transactions

Service Delivery Processes

•Satisfaction with care management processes•Amenities to reduce anxiety, increase comfort

Service Delivery ProcessesService Delivery Processes

•Satisfaction with care management processes•Amenities to reduce anxiety, increase comfort

ClinicalExcellence!

ClinicalExcellence!

SupportiveSupportive

PrimaryPrimary

Patient (consumer)preferences, beliefs

and values

Patient (consumer)preferences, beliefs

and values

Evidence-based medicine is not understoodEvidenceEvidence--based medicine is not understoodbased medicine is not understood

“Evidence-based medicine is the judicious application of relevant scientific studies to patient preferences and values.”

“Evidence-based medicine is the judicious application of relevant scientific studies to patient preferences and values.”

Judiciousintegration

of relevant science

Judiciousintegration

of relevant science

Clinician trainingand experience

Clinician trainingClinician trainingand experienceand experience

Guidelines: The Framework for Evidence-based MedicineGuidelines: Guidelines: The Framework for EvidenceThe Framework for Evidence--based Medicinebased Medicine

“Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”

– IOM ’92

Derived from…

20,000 RCTs annually

4,000 guidelines since 1989

2,500 periodicals in NLS

Every guideline is not evidence-based, and some

guidelines are about who, what should be done

Derived from…

20,000 RCTs annually

4,000 guidelines since 1989

2,500 periodicals in NLS

Every guideline is not evidence-based, and some

guidelines are about who, what should be done

PICO: the framework for guidelines…PICO: the framework for guidelines…

P… what’s the population?

I…what intervention am I testing?

C… compared to what other intervention?

O… what outcome is being tested?

P… what’s the population?

I…what intervention am I testing?

C… compared to what other intervention?

O… what outcome is being tested?

Then evidence-linked algorithms form the framework for guidelinesThen evidenceThen evidence--linked algorithms form the linked algorithms form the framework for guidelinesframework for guidelines

Studies are graded using various schemes..Studies are graded using various schemes..

In practice, tools are used to stay abreast..In practice, tools are used to stay abreast..

Systematic ReviewsCochrane LibrarySystematic ReviewsCochrane Library

Clinical EvidencePOEMsClinical EvidencePOEMs

Value

Medline, PubMedMedline, PubMed

EBM Practice GuidelineEBM Practice Guideline

CATs, Best Evidence,ACP Journal ClubCATs, Best Evidence,ACP Journal Club

Reviews: Up-to-Date, 5-Min Clinical ConsultReviews: Up-to-Date, 5-Min Clinical Consult

Better care is the result; it is also a more efficient way to operate a clinical enterpriseBetter care is the result; it is also a more Better care is the result; it is also a more efficient way to operate a clinical enterpriseefficient way to operate a clinical enterprise

Outcomes (p<0.0001)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Death RespiratoryFailure

ProlongedLength of Stay

Elevated TotalCharges

Blood Cultures AppropriateAntibiotics

Pathway non Pathway Ann. Epidemiology 2004:14:669-675

And then we draw conclusions: what do we learn by examining the evidence?And then we draw conclusions: what do we learn And then we draw conclusions: what do we learn by examining the evidence?by examining the evidence?

Observational Study (n=1): why women live longer than men!”Observational Study (n=1): why women live longer than men!”

The data correlates adherence to evidence-based practice with…The data correlates adherence to evidence-based practice with…

Improved outcomes

Reduced variation

Improved patient adherence

Improved efficiency

Reduced errors

So why isn’t evidence-based practice more consistently provided?

Improved outcomes

Reduced variation

Improved patient adherence

Improved efficiency

Reduced errors

So why isn’t evidence-based practice more consistently provided?

Challenge: Knowledge ExplosionChallenge: Knowledge Explosion

20,000 biomedical journals

>150,000 medical articles published

each month

>300,000 randomized controlled trials

“We are drowning in “We are drowning in information but starved information but starved for knowledge.”for knowledge.”——NaisbittNaisbitt, ‘82, ‘82

Challenge: Lack of EvidenceChallenge: Lack of Evidence

How many questions have any evidence? (BMJ 2000)

0 50 100 150 200 250 300 350 400

Uncertain 375Uncertain 375

Partial Answer 299Partial Answer 299

Answered 358Answered 358Beneficial …………………….. 248Ineffective or harmful ……….. 43Trade-off ……………………… 67

Likely to be beneficial ………. 235Unlikely to be beneficial ……. 64

Unknown effectiveness …….. 375Number of Interventions

Challenge: Source CredibilityChallenge: Source Credibility

Shaneyfelt et al: (JAMA, 1999)

Of 279 guidelines developed by medical societies, most do not adhere to IOM standards for methodological review (evidence-grading)

Grilli et al: (Lancet, 2000)

431 guidelines reviewed; 82% lack evidence-grading review assessment

Shaneyfelt et al: (JAMA, 1999)

Of 279 guidelines developed by medical societies, most do not adhere to IOM standards for methodological review (evidence-grading)

Grilli et al: (Lancet, 2000)

431 guidelines reviewed; 82% lack evidence-grading review assessment

Challenge: ReliabilityChallenge: Reliability

YOU ARE

HERE

Challenge : TimelinessChallenge : TimelinessChallenge : TimelinessThe solid line represents the Kaplan-Meier

curve for the Agency for Healthcare Research and Quality (AHRQ) guidelines.

Dashed lines representthe 95% confidence interval

(JAMA. 2001;286:1461-1467)

◙–

Challenge: Commercial InterestsChallenge: Commercial InterestsChallenge: Commercial Interests

1. Digital imaging

2. Drug-coated stents

3. Oral cancer treatments

4. Minimally invasive surgery

5. Sepsis treatment

6. Implantable devices

7. Microscopic cameras

8. Diabetes devices

9. At-home health test kits

10. Embryonic stem cell research

Challenge: Media AttentionChallenge: Media Attention

Challenge: Physician TrainingChallenge: Physician Training

Provide patient centered careWork in interdisciplinary teamsEmploy evidence-based practiceApply quality improvementUtilize informatics

Health Professions Education: A Bridge to Quality

Institute of Medicine 2003

73% of patients depend on physicians to make decisions for them!73% of patients depend on physicians to make decisions for them!

“INFORMED” PARENTAL

“INFORMED” PARENTAL

INTERMEDIATE SHARED DECISION MAKING

INTERMEDIATE SHARED DECISION MAKING

PATIENT AS DECISION-MAKER

PATIENT AS DECISION-MAKER

4.8%Stronglydisagree

4.8%Stronglydisagree

*Adapted from Guyatt et al. Incorporating Patient Values in: Guyatt et al. Users’ Guide to the Medical Literature: Essentials

of Evidence –based Clinical Practice. JAMA 2001**Arora NK and McHorney CA. Med Care. 2000; 38:335

17.1% Strongly

Agree

17.1% Strongly

Agree

45%Agree45%

Agree11%11% 22.5%

Disagree22.5%

Disagree

Challenge: Consumer ExpectationsChallenge: Consumer Expectations

Lots of explanations and excuses…Lots of explanations and excuses…Lots of explanations and excuses…

“they don’t pay for it..”

“the tools aren’t available”

“my patients don’t care”

“it’s a fad”

“the only evidence I need is what I know”

So what does this have to do with safety?So what does this have to do with safety?

EBM, quality and safety are closely related…EBM, quality and safety are closely EBM, quality and safety are closely related…related…

Clinical Processes

•Adherence to evidence-based pathways in the diagnosis and intervention planning with patients

•Safe, effective, timely, patient-centered care•Collaborative care management

Clinical ProcessesClinical Processes

•Adherence to evidence-based pathways in the diagnosis and intervention planning with patients

•Safe, effective, timely, patient-centered care•Collaborative care management

Structural Processes

•Access to needed services in appropriate settings•Paperwork/administrative procedures to access

services and document transactions

Structural ProcessesStructural Processes

•Access to needed services in appropriate settings•Paperwork/administrative procedures to access

services and document transactions

Service Delivery Processes

•Satisfaction with care management processes•Amenities to reduce anxiety, increase comfort

Service Delivery ProcessesService Delivery Processes

•Satisfaction with care management processes•Amenities to reduce anxiety, increase comfort

ClinicalExcellence!

ClinicalExcellence!

SupportiveSupportive

PrimaryPrimary

QualityQualityImprovementImprovement

“Do things well”“Do things well”

“It’s cookbook “It’s cookbook Medicine”Medicine”

“we don’t have “we don’t have the tools”the tools”

“we never did“we never didit that way before”it that way before”

SafetySafety“Do no harm”“Do no harm”

Clinical ExcellenceClinical Excellence“Do right things well”“Do right things well”

The application of EBM to safety is foundationalThe application of EBM to safety is foundational

Safe, evidence-based careSafe, evidenceSafe, evidence--based carebased care

Clinical Processes•Effective

•Patient Centered

Clinical ProcessesClinical Processes••EffectiveEffective

••Patient CenteredPatient Centered

Structural Processes•Equitable•Accessible

Structural ProcessesStructural Processes•Equitable•Accessible

Service Delivery Processes

•Timeliness, Efficient•Equitable

Service Delivery ProcessesService Delivery Processes

•Timeliness, Efficient•Equitable

ClinicalExcellence!

ClinicalExcellence!

SupportiveSupportive

PrimaryPrimary

Admissions ManagementEvaluating appropriately, directing

resources effectively

Admissions ManagementAdmissions ManagementEvaluating appropriately, directing Evaluating appropriately, directing

resources effectivelyresources effectively

Care Team ManagementRecruiting, equipping and

holding accountable care teams

Care Team ManagementCare Team ManagementRecruiting, equipping and Recruiting, equipping and

holding accountable care teamsholding accountable care teams

Pathway ManagementBuilding and updating pathways,

order sets and guidelines for care teams

Pathway ManagementPathway ManagementBuilding and updating pathways, Building and updating pathways,

order sets and guidelines for care teamsorder sets and guidelines for care teams

Outcome ManagementMeasuring what works best and why

Outcome ManagementOutcome ManagementMeasuring what works best and whyMeasuring what works best and why

Risk ManagementAvoiding error, conducting

root cause analysis

Risk ManagementRisk ManagementAvoiding error, conducting Avoiding error, conducting

root cause analysisroot cause analysis

Discharge ManagementTeaching, equipping patients for

guided self-care, follow-up

Discharge ManagementDischarge ManagementTeaching, equipping patients for Teaching, equipping patients for

guided selfguided self--care, followcare, follow--upup

For a provider organization, there are six key operational applications where EBM is central…For a provider organization, there are six key For a provider organization, there are six key operational applications where EBM is central…operational applications where EBM is central…

Physician leadership is essential!Physician leadership is essential!

Point of care decision-support tools are essentialPoint of care decisionPoint of care decision--support tools are essentialsupport tools are essential

0 5 0 10 0 15 0 2 0 0 2 5 0 3 0 0

Clinical Information

ComputerizedPhysician Order Entry

Decision Support

Electronic MedicalRecord

Medical Management

HCIT: Where do we start selecting companies?Numbers of companies currently supporting these applicationsHCIT: Where do we start selecting companies?HCIT: Where do we start selecting companies?Numbers of companies currently supporting these applicationsNumbers of companies currently supporting these applications

Source: 2005 Healthcare Informatics, Resource GuideSource: 2005 Healthcare Informatics, Resource Guide

129129

259259

197197

165165

246246

The cat is out of the bag!!The cat is out of the bag!!The cat is out of the bag!!

SummarySummary

EBM is a journey to clinical excellence: it’s about safety, quality improvement and evidence-based care

Applying EBM to error avoidance is fundamental: it leverages research about efficacy and effectiveness

To deliver safe evidence-based care, an organization must invest in processes and information technologies to support leaders in the journey

Our results will be public.

EBM is a journey to clinical excellence: it’s about safety, quality improvement and evidence-based care

Applying EBM to error avoidance is fundamental: it leverages research about efficacy and effectiveness

To deliver safe evidence-based care, an organization must invest in processes and information technologies to support leaders in the journey

Our results will be public.

ContactContactContact

Paul H. Keckley, Ph.D.Paul H. Keckley, Ph.D.Executive DirectorExecutive DirectorVanderbilt Center for EvidenceVanderbilt Center for Evidence--based Medicinebased MedicineAssociate ProfessorAssociate ProfessorVanderbilt University School of MedicineVanderbilt University School of MedicineDD--3300 Medical Center North3300 Medical Center NorthNashville, TN 37232Nashville, TN 37232--21042104paul.keckley@vanderbilt.edupaul.keckley@vanderbilt.edu615615--343343--39223922www.ebm.vanderbilt.eduwww.ebm.vanderbilt.edu