Evidence-Based Approach

for

Clinical Governance

Iranian Center for EBM

Sakineh Hajebrahimi MD Professor of Urology Department Tabriz University of Medical Sciences

Agenda

Evolution of medicine and evidence-based medicine (EBM)

The EBM approach and evidence-based decision making

Translating research into practice and practice into research

A Scenario

Patient Physician relation-

Tabriz 2012

Hadi Mostafaie et al

Archie Cochrane - 1972

Certainty/ Agreement

Far from certainty (effectiveness)

Close to certainty (effectiveness)

Close to agreement 1 2

Far from agreement

3 4

Try to do no harm, 15% in area 2

Beware of Initial Appearances

Looking at the surface is not enough!

Evaluation of Medical Care

Safety Side effects acceptable?

Efficacy Can it work?

Effectiveness Does it work?

Efficiency Is there sufficient value?

Efficacy: Net benefit optimal conditions

Effectiveness: Net benefit average conditions

Patients’ Safety:

Efficacy

› If taken, does the treatment have an effect?

Effectiveness

› Will the treatment have good results if offered?

› Takes into account tolerability and harmful effects

› Better external validity

Patient-oriented research

The two "Death Valleys" of the

clinical translational

continuum

Does an intervention work?

Case reports

Clinical experience

Case series

Case control study

Cohort study

Randomised, placebo controlled clinical study

Clinical Decision Making

Clinical Problem: Asymptomatic 65 yo man

“Should I have that blood test to check

for prostate cancer?”

Screening for Prostate Cancer Experts recommend for

YES - You should screen with PSA test:

American Cancer Society

American College of Radiology

American Urologic Association

Local experts, incentives

Screening for Prostate Cancer Experts recommend against

NO - You should not screen with PSA:

US Preventive Services Task Force

Canadian Task Force

National Cancer Institute

others (Sweden, United Kingdom, etc.)

Cons of Screening Screening PSA is Unproven

No randomized trial has shown benefit

Economic costs

• every man over 50

• unnecessary follow up Dx and Tx

Psychologic and social costs

• false positives think they have cancer

• false negatives think they don‟t

„do no harm’

Evolution of Evidence-based Medicine

Early 20th Century

Mid-Late 20th Century

(EBM)

End of 20th Century: Health Care Costs Explode

Early 21st Century Application of EBM

The Evidence-Based Approach

What is evidence based

medicine?

Evidence-based medicine(EBM) is the integration of best research evidence with clinical expertise and patient values (Sackett et al 1999)

A model of Evidence Based

decisions

Patient Values Clinical Expertise

Best research evidence

Decision

Realisations

Daily need for valid up to date information

Inadequacy of traditional resources

Gap between clinical judgment which over time while up to date theoretical knowledge over time

Time limitation for finding evidence

FIVE steps

Convert information needs into an answerable question

Find the best evidence

Appraise validity, impact and applicability

Integrate appraisal with clinical expertise

Evaluate performance

Limitations*

Time.

Shortage of coherent and consistent

scientific evidence (therapeutic

nihilism).

Challenges of applying evidence to

care of individual patients.

General barriers to the practice of

quality medicine (e.g. costs, patient

expectations, etc.).

Why do we need systematic

reviews of the evidence?

No-one can possibly read, or find, all the trials and all the data about all specific clinical questions

Once found, trials may appear to give conflicting or contradictory results

But what about?

Qualitative research

Focus groups,

Delphi

techniques,

Interviews

Audits, surveys

etcetera

Non-research

RCTs

SRs

CER, HTA and EBM Comparative effectiveness research (CER)

Absolute and relative clinical effectiveness of alternative

management strategies across patients, populations and

routine practice settings

Evidence generation and synthesis

Evidence based medicine (EBM)

Individual clinical decision making and policy and group-

focused evidence-based decision process (clinical

guidelines, reimbursement coverage decisions)

Health technology assessment (HTA)

Explicit, comprehensive assessment long-term benefit–risk

tradeoff (benefits; harms)

International Working Group for HTA Advancement. Luce BR, Drummond MF, Jonsson B, Neumann PJ, Schwartz JS, Siebert U, Sullivan SD. EBM, HTA, and CER: Clearing the Confusion. Milbank Memorial Fund Quarterly. In press.

Relationships of Evidence Processes:

EBM, CER, and HTA

International Working Group for HTA Advancement. Luce BR, Drummond MF, Jonsson B, Neumann PJ, Schwartz JS, Siebert U, Sullivan SD. EBM, HTA, and CER: Clearing the Confusion. Milbank Memorial Fund Quarterly. In press.

Evidence Processes

International Working Group for HTA Advancement. Luce BR, Drummond MF, Jonsson B, Neumann PJ, Schwartz JS, Siebert U, Sullivan SD. EBM, HTA, and CER: Clearing the Confusion. Milbank Memorial Fund Quarterly. In press.

Evidence Assessment:

Goal

To provide a rigorous scientific basis for clinical and policy decision making to: • Optimize health outcomes • Reduce incorrect decision making and

resulting missed opportunities and harms

• Improve quality of care, patient and

population health and efficiency of health services delivery

Comparative Effectiveness Research:

How will the evidence be used?

• Individual patient care

• Clinical guidelines

• Reimbursement

Outcomes of interest and quality and integrity of data analysis and interpretation may differ across uses and users

Now we have found some evidence. Can we apply

the evidence to this case?

Validity

Impact

applicability

Relevance of evidence based

medicine to pharmacists

All areas of practice require decisions about optimal therapy (including no therapy) to improve patient outcomes

Information often comes to the pharmacist in an incomplete fashion

Pharmacists giving advice and being proactive in therapeutics need accurate information sources

Some limitations of evidence

based medicine

Many questions do not have answers!

Evidence from populations - relevance to individual

Trials - not „real‟ usage

Lack of local ownership of recommendations

Clinical effectiveness vs cost effectiveness

Research and Clinical Effectiveness

All clinical decisions and actions initiated by or on

behalf of the HOSPITAL should be:

• Promote and monitor clinical effectiveness

• Encourage and monitor the use of evidence based

practice

Some of the steps include:

• Developing and agreeing evidence based protocols of

care

• Ensuring that the standards and guidelines are implemented throughout the HOSPITAL

• Providing training on searching for evidence is available to all staff.

• Developing systems to determine whether clinically effective practice is being implemented at grass roots level.

• Ensuring that research governance arrangements are in place

• Ensuring that evidence based prescribing is implemented

Summary

Evidence based medicine is an effective tool to maximise optimal outcomes for our patients

Pharmacists need to learn how to incorporate evidence based principles in their practice

Pharmacists can contribute to local implementation of evidence based guidelines

Final important steps

Apply results in practice

range of behavioural and educational interventions to facilitate culture of change

Evaluate your performance

Audit

Accreditation

Ongoing evaluation alongside innovation (compare health services research)

Evidence-based . . . .

Evidence-based Medicine (EBM)

• Patient care based on evidence from the best available studies

Evidence-based Decision Making • EBM extended to include population-based decision making

in the form of guidelines and formulary decisions using formal evidence criteria and deliberative processes

Comparative Effectiveness • Subset of EBM which assesses alternative therapies

Goals of Explicit,

Evidence-based Approach Credibility

Transparency

• People can understand what you did

Systematic

Reproducibility, limit bias

• Different people would get same result

Identify gaps in evidence

• Highlight where we need better evidence

Reduce the chance of “getting it wrong”

Evidence Review

and Synthesis (Formulary Committee Staff,

EPCs, DERP)

Evidence-Based

Decision Making (Formulary Committee

of PBM, Private Payer,

States)

Economic

Information

Studies

Framing

Key Questions

Rigor Required

Decisions

1

Evidence

Review

2

3

Budget

Constraints

Dynamic Relationship Between Evidence

Review & Synthesis and Evidence-based

Decision Making

Acceptability

Teutsch S, Berger M, Evidence Synthesis and Evidence-based Decision Making: Related But Distinct Processes. Medical Decision Making 2005;25:487-9.

The Two Faces of “TRIP”

Funding research on transferring research into practice

versus

Embedding the transfer of research into practice within the culture of universities, health care organizations and research funders

Efficacy vs. Effectiveness Clinical Trials Clinical Practice

Efficacy Effectiveness

Single diagnosis High-risk patients with co-morbid conditions

Drug vs. placebo Multiple drug choices and alternatives

Exclusions of user groups e.g., elderly

Use is generally unlimited

Clinical endpoints, biomarkers

Death, disability, QoL

Genetics/biology Sociology/psychology

“Artificial” settings Real world clinics

Consequences of EBM Paradigm

Basic Science

Clinical Research

EBM Literature

Synthesis

Evidence-based Guidelines

Reimbursement, Coverage

and Incentives

Comparative Effectiveness

Inform R&D Needs Relative Value (Cost Effectiveness)

Bio

med

ical

Mo

del

EB

M /

HE

CO

N

Mo

del

Po

licy

Decis

ion

s

Determine Access

to Services

Determine

Appropriate Care

Quality Improvement

Determine Outcomes

Of Care

Translating Research into Practice

Study systems for quality improvement

• Organization and structure of care

• Reimbursement and incentives

• Information systems

• Community and patient engagement

• Training

“In the midst of every challenge

lies opportunity”

Albert Einstein

&

“The illiterate of 21st century will not be those who cannot read and

write, but those who cannot learn, unlearn and relearn”

Thanks