From

Evidence-Based Medicine
to
Evidence-Based Policy
Prof. dr. Mohammad Hakimi, SpOG(K), PhD.
Case Presentation:
Prophylactic Antibiotics for C-Section
Introduction
Antibiotic prophylaxis is useful in reducing incidences of
surgical (operation) site infection.
The use of antibiotic prophylaxis is however
characterized by inappropriate practices such as use of
broad-spectrum antibiotics; administering at wrong
time; and continuing for too long
Use of single dose has been found to be as effective as
multiple doses and also cost effective to patients [1].
The recommended duration of prescribed antibiotics
prophylaxis for c-section has reduced from 5 days to 3
days then to 24 hrs and finally to a single dose [2] .
DUE serves as a structured criteria based method of
identifying, monitoring and correcting challenges
encountered in practice
[1] Hopkins L, Smaill F. Antibiotic prophylaxis regimens and drugs for cesarean section. Cochrane Database of Systematic Reviews 1999, Issue 2
[2] Liabsuetrakul T, Lumgiganon P and Chongsuvivatwong V, Prophylactic Antibiotic Prescription for Cesarean Section, International Journal for
Quality in Health Care 2002: Vol.14(6) pp. 503-508
Cost Implications of Overuse of Antibiotics
Mater Hospital, Kenya

-
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
Co-Amoxiclav 412,200 1,236,600 824,400
Yearly Cost for 1
dose
Yearly Cost for 3
doses
Extrapolated
Cost Savings
Illustration using Co-amoxiclav Inj. 1.2g -Extrapolated to 600
C-Sections Annually

Summary of Cost Implications* of Antibiotic
Overuse
Component Co-Amoxiclav Cefuroxime
Yearly Cost for 1 dose 412,200 358,200.00
Yearly Cost for 3 doses 1,236,600 -
Extrapolated Cost Savings per year
for using a single dose 824,400 878,400.00
Yearly Cost for additional oral
antibiotic [10 doses] 619,273 954,436.36
Average cost saving per patient on
eliminating oral antibiotics 1,310 2,019.00
Estimated cost saving per year on
eliminating use of oral antibiotics 786,855
Estimated Cost Savings per year for
using a single dose of Cefuroxime Inj 1,665,255
*Note: Costs extrapolated to 600 C-sections annually

Antibiotics Prophylaxis for C-section
Administration of single dose is relatively rare
Use of 3 doses, instead of a single dose of Co-amoxiclav
carries huge cost implications as illustrated above.
To increase the quality of antimicrobial prophylaxis in
Caesarean section surgery, efforts should be put into
developing guidelines acceptable to all disciplines.
Other consequences of overuse of antibiotics include:
Increase in antibiotic resistance and adverse drug
reactions
Increase in costs of healthcare including costs of
drugs, pharmacy time, nursing care and time, and
cost of consumables e.g. syringes, needles
Key Lessons learned
Fear of the unknown - Irrational prescribing
Combination of strategies is critical for
sustainable improvement
Slight policy changes can result in significant
cost savings
Teamwork and mentorship is key in ensuring
continuity of intervention despite staff turnover
Dedication and motivated staff are key in
sustaining
Operational research should be integrated into
regular schedule for maximum effectiveness
Strategies to Improve Antibiotic Use
Evidence-Based Medicine
Evidence-Based Policy
Paradigm Shift:
Evidence-Based Medicine
De-emphasizes intuition, unsystematic clinical
experience, and pathophysiologic rationale as
sufficient grounds for clinical decision making
Stresses the examination of evidence from
clinical research
Requires new skills of the physician, including
efficient literature searching and the
application of formal rules of evidence
evaluating the clinical literature
What is EBM?
Evidence-based medicine (EBM)
requires the integration of:
1. The best research evidence
with
2. Our clinical expertise
and
3. Our patients unique values and
circumstances.
How Do We Actually Practice EBM?
Step 1: converting the need for information
(about prevention, diagnosis, prognosis,
therapy, causation, etc.) into an answerable
question.
How Do We Actually Practice EBM?
Step 2: tracking down the best evidence with
which to answer that question.
How Do We Actually Practice EBM?
Step 3: critically appraising that evidence for
its
validity (closeness to the truth),
impact (size of the effect), and
applicability (usefulness in our clinical practice).
How Do We Actually Practice EBM?
Step 4: integrating the critical appraisal with
our clinical expertise and with our patients
unique biology, values, and circumstances.
How Do We Actually Practice EBM?
Step 5: evaluating our effectiveness and
efficiency in executing steps 14 and seeking
ways to improve them both for next time.
Scenario
You are charged with formulating a local clinical
policy in your hospital about antibiotics prophylaxis
at caesarean sections
The Clinical Question
Which antibiotic regimen is most effective in
reducing the incidence of infectious morbidity in
women undergoing cesarean section?


Structured Question
Participants Women undergoing any type of caesarean
sections
Intervention A single dose of prophylactic antibiotic
Comparison A multiple dose of prophylactic antibiotic
Outcomes Maternal: febrile morbidity, endometritis, wound
infection and pyelonephritis.
Neonatal: neonatal sepsis, neonatal septic work-
up and neonatal intensive-care unit (NICU)
admission.
19 19
Hierarchy of Evidence
Best
Evidence
Worst
Evidence
The Evidence
Hopkins L, Smaill F. Antibiotic prophylaxis
regimens and drugs for cesarean section.
Cochrane Database of Systematic Reviews
1999, Issue 2. Art. No.: CD001136. DOI:
10.1002/14651858.CD001136.
Main Results 1/3
Fifty-one trials published between 1979 and
1994 were included in the review and four
were excluded from the review.
The following results refer to reductions in the
incidence of endometritis.
Main Results 2/3
Both ampicillin and first generation
cephalosporins have similar efficacy with an
odds ratio (OR) of 1.27 (95% confidence
interval (CI): 0.84-1.93).
In comparing ampicillin with second or third
generation cephalosporins the odds ratio was
0.83 (95% CI 0.54-1.26) and in comparing a
first generation cephalosporin with a second
or third generation agent the odds ratio was
1.21 (95% CI 0.97-1.51).
Main Results 3/3
A multiple dose regimen for prophylaxis
appears to offer no added benefit over a
single dose regimen; OR 0.92 (95% CI 0.70-
1.23).
Systemic and lavage routes of administration
appear to have no difference in effect; OR 1.19
(95% CI 0.81-1.73).
Authors Conclusions
Both ampicillin and first generation
cephalosporins have similar efficacy in reducing
postoperative endometritis.
There does not appear to be added benefit in
utilizing a more broad spectrum agent or a
multiple dose regimen.
There is a need for an appropriately designed
randomized trial to test the optimal timing of
administration (immediately after the cord is
clamped versus pre-operative).
Strategies to Improve Antibiotic Use
Managerial Strategies
Drug use evaluation
Guideline on antibiotic prophylaxis in C-section.
Clinical pharmacy programs.
Use of automatic stop orders
Educational Strategies
Face-to-face communication
Education outreach
Group sessions
Influencing opinion leaders
Printed educational materials
Policy
The definition of policy is often broad,
including laws, regulations, and judicial
decrees as well as agency guidelines and
budget priorities.
Policy
Policy is a set of principles guiding decision
making.
Walt (1994) distinguishes between systemic
(macro) policy, which determines the basic
characteristics of a society, and sectoral
(micro) policy, which concerns lower-level
decisions within it.

Spasoff RA. Epidemiologic Methods for Health Policy. New York,
NY: Oxford University Press; 1999.
Evidence in
Evidence-Based Policy
For policy-relevant evidence, both quantitative data
(e.g., epidemiological) and qualitative information
(e.g., narrative accounts) are important.
Policymakers operate on a different hierarchy of
evidence than scientists, leaving the 2 groups to live
in so-called parallel universes.
Policy makers were not trained to distinguish
between good and bad data, and were, therefore,
prone to the influence of misused facts often
presented by interest groups.
Barriers to Implementing Effective
Public Health Policy 1/6
Barrier Example
Lack of value placed on
prevention
Only a small percentage of
the annual US health care
budget is allocated to
population-wide
approaches.
Insufficient evidence base The scientific evidence on
effectiveness of some
interventions is lacking or
the evidence is changing
over time.
Barriers to Implementing Effective
Public Health Policy 2/6
Barrier Example
Mismatched time horizons Election cycles, policy
processes, and research
time often do not match
well.
Power of vested interests Certain unhealthy interests
(e.g., tobacco, asbestos)
hold disproportionate
influence.
Barriers to Implementing Effective
Public Health Policy 3/6
Barrier Example
Researchers isolated from
the policy process
The lack of personal
contact between
researchers and
policymakers can lead to
lack of progress, and
researchers do not see it
as their responsibility to
think through the policy
implications of their work.
Barriers to Implementing Effective
Public Health Policy 4/6
Barrier Example
Policymaking process can
be complex and messy
Evidence-based policy
occurs in complex systems
and social psychology
suggests that decision-
makers often rely on habit,
stereotypes, and cultural
norms for the vast
majority of decisions.
Barriers to Implementing Effective
Public Health Policy 5/6
Barrier Example
Individuals in any one
discipline may not
understand the
policymaking process as a
whole
Transdisciplinary
approaches are more likely
to bring all of the
necessary skills to the
table.
Barriers to Implementing Effective
Public Health Policy 6/6
Barrier Example
Practitioners lack the skills
to influence evidence-
based policy
Much of the formal
training in public health
(e.g., masters of public
health training) contains
insufficient emphasis on
policy-related
competencies.
Domains of Evidence-Based Public
Health Policy 1/3
Domain Objective Data Source Example
Process To understand
approaches to
enhance the
likelihood of
policy
adoption
Key informant
interviews
Case studies
Surveys of
setting-specific
political
contexts
Understanding
the lessons
learned from
different
approaches
and key
players
involved in
state health
reforms.
Domains of Evidence-Based Public
Health Policy 2/3
Domain Objective Data Source Example
Content To identify
specific policy
elements that
are likely to be
effective
Systematic
reviews
Content
analyses
Developing
model laws on
tobacco that
make use of
decades of
research on
the impacts of
policy on
tobacco use.
Domains of Evidence-Based Public
Health Policy 3/3
Domain Objective Data Source Example
Outcome To document
the potential
impact of
policy
Surveillance
systems
Natural
experiments
Tracking
policy-related
endpoints
Tracking changes
in rates of self-
reported seat belt
use in relation to
the passage of
seat belt laws.
Describing the
cost-effectiveness
of child
immunization
requirements.
Brownson RC, Chriqui JF, and Stamatakis KA.
Understanding Evidence-Based Public Health Policy.
Am J Public Health 2009;99:15761583.
It has long been known that public health
policy, in the form of laws, regulations, and
guidelines, has a profound effect on health
status.
For example, in a review of the 10 great public
health achievements of the 20
th
century, each
of them was influenced by policy change such
as seat belt laws or regulations governing
permissible workplace exposures.
Brownson RC, Chriqui JF, and Stamatakis KA.
Understanding Evidence-Based Public Health Policy.
Am J Public Health 2009;99:15761583.
As with any decision-making process in public
health practice, formulation of health policies
is complex and depends on a variety of
scientific, economic, social, and political
forces.
Criteria used to evaluate policy
recommendations
Supported by systematic, empirical evidence
Supported by cogent argument
Scale of likely health benefit
Likelihood that the policy would bring benefits other
than health benefits
Fit with existing or proposed government policy
Possibility that the policy might do harm
Ease of implementation
Cost of implementation

Macintyre, et al. Using evidence to inform health policy: case study.
BMJ 2001;322:2225.
Axes of evidence-based decision-making
Dobrow et al. Evidence-based health policy: context and utilisation. Social Science
& Medicine 2004;58:207217.
Politicians dont like evidence-based decision
making; they prefer decision-based evidence
making.

Retired Federal Government Scientist