evidence-based approach for clinical...
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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
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