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General principle on

pregnancy and childbirth


Evidence Based Obstetrics
Guidelines and protocols
Lesson/Package 1

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

At the end of this presentation students will


be able to understood

General principle on pregnancy


and childbirth
Evidence Based Obstetrics (basic
concepts on EBM)

Guidelines and protocols (basic


concepts)

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

General principle on pregnancy and childbirth

MakingPregnancy Safer: Fundamentals and


Principles
Fundamentals:
Care for pregnancy and childbirth calls for a holistic approach.
Pregnancy and childbirth is an important personal, familial, and
social experience.
Inpregnancy and childbirth there should be a valid reason to
interfere with the natural process.
Medical interventions forpregnant women, mothers and
newborns, if indicated,need to be available, accessible, appropriate
and safe.

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

General principle on pregnancy and childbirth


Principles:
Based on these fundamentals, the care for pregnancy and childbirth
should:
ensure involvement of women in decision-making for options of
care, as well as for health policies;
be family centred, respecting confidentiality, privacy, culture,
belief and emotional needs of women, families and communities;
be based on scientific evidence, and cost effective;
ensure a continuum of care from communities to the highest level
of care, including efficient regionalization, and multidisciplinary
approach.
These fundamentals and principles of MPS/PEPC in the European Region were developed at PEPC/MPS Task Force
meetings in Venice (1998), Verona (2003) and MPS Experts Meeting Catania, Italy (2007).

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

Key message
Other things being equal, all elements of
health care should be based on evidence
of effectiveness and cost-effectiveness.
Some convincing reasons, however, do
exist to suggest that we as obstetricians
have a special responsibility and that
obstetrics may be 'more equal' than other
health disciplines in its need to be based
on solid evidence.
Enkin, Murray W. MD
The need for evidence-based obstetrics [Editorial]
ACP J Club, Volume 1().July-Aug 1996.132 Evidence-Based Medicine

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

Why ??
First among these reasons is the special nature of our
clientele. In most fields of medical care, persons come
to the doctor because they are ill and seek a cure or
relief. In obstetrics, pregnant women come to us
healthy but with an iatrogenic belief that obstetrical
care will further improve the excellent outcomes that
nature has already provided to them. The
professionally engendered nature of our care increases
our responsibility. The presence of the baby, who has
no choice in the matter, doubles it.
Enkin, Murray W. MD
The need for evidence-based obstetrics [Editorial]
ACP J Club, Volume 1().July-Aug 1996.132 Evidence-Based Medicine

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

Evaluating Current Practices

What am I doing?

Why am I doing this?

Will this reach my goal?

Is there a better or more acceptable


way to reach my goal?

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

The Problems
We need evidence (about the accuracy of
diagnostic tests, the power of
prognostic markers, the comparative
efficacy and safety of interventions,
etc.) about 5 times for every in-patient
(and twice for every 3 out-patients).
We get less than a third of it
TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

The Problems
To keep up to date in Obstetrics, I need
to read 17 articles a day, 365 days a
year
Need to read
Dont
Nor does anyone else

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

The Problems
Reported and observed information sources of doctors
Info rmatio n so urce

Reported

Obse rved

Print sources

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General and specialist


textbo oks

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Pharmaceutical textbo oks

14

Journals

18

Drug company information

Self made compendia

Human sources

33

53

Specialist doctors

18

24

Generalist doctors

Office partner

Pharmacist

Other

21

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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The Problems
Thrombolytic therapy Research and textbooks
Year

Textbooks recommendations

1 Routine use
2 Specific use
3 Experimental use
4 Not Mentioned

Better Treatment - Better Control

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

Antman EM et al., 1992

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The Problems
1601

Captain Lancaster demonstrated that lemon


juice prevents scurvy

In 146 years
1747

The Royal Navy repeats Lancasters results


with a systematic experiment done by
James Lind, on the RS Salisbury

In 48 years
1795

The Royal Navy decides to give lemon juice


to mariners

In 70 years
1865

The British Merchant Navy started to give


lemon juice to the mariners
TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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E.B.M.
Archie
Archie Cochrane
Cochrane
(1913
(1913 -- 1988)
1988)
It is surely a great criticism of our profession that we have not
organised a critical summary, by speciality or subspeciality, adapted
periodically, of all relevant randomized controlled trials

Evidence-based medicine

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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The wooden spoon


'Of all medical specialties it is in obstetrics and gynaecology in which
clinical practice is least likely to be supported by scientific evidence.
They have a distinguished past. . . . but the specialty seems to have
slipped up recently. The specialty missed its first opportunity in the 60s
when it failed to randomize the confinement of low risk pregnant women
at home and in hospital. Then having filled the emptying beds by getting
nearly all pregnant women into hospital, obstetricians started to introduce
a whole series of expensive innovations into the routine of pre and
postnatal care and delivery, without any rigorous evaluation. The list is
long, but most important were induction, ultrasound, fetal monitoring, and
placental function tests. The specialty reached its apogee in 1976 when
they produced 20% fewer babies at 20% more cost. After due thought
and meditation, but without prayer, I awarded them the wooden spoon'
Cochrane AL. 1931-1971: a critical review, with particular reference to the medical
profession. In: Medicines for the year 2000. London: Office of Health Economics;
1979:1-11

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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Definitions of EBM
The process of systematically finding,
appraising, and using contemporaneous
research findings as the basis for clinical
decisions
MeSH - National Library of Medicine

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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Definitions of EBM
the conscientious, explicit, and judicious
use of current best evidence in making
decisions about the care of patients
means integrating individual clinical
expertise with the best available external
evidence evidence
Sackett et al. BMJ 1996;312:70-71

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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Transferring evidence from research to practice

Clinical Expertise

Research Evidence

Patients Preferences
Haynes et al, 1996, Sackett et al, 2000

TBILISI STATE MEDICAL UNIVERSITY - UNICEF GEORGIA

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Three solutions
Clinical performance can keep up to date:
1 by learning how to practice evidencebased medicine ourselves.
2 by seeking and applying evidence-based
medical summaries generated by others.
3 by applying evidence-based strategies for
changing our clinical behaviour.

http://www.ncbi.nlm.nih.gov/pubmed/
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http://www.who.int/rhl/en/
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What evidence-based medicine


is:
The practice of EBM is the integration of
individual clinical expertise
with the
best available external clinical evidence
from systematic research.
and
patients values and expectations

I.Individual Clinical Expertise:


Clinical skills and clinical judgement
Vital for determining whether the evidence
(or guideline) applies to the individual
patient at all and, if so, how

II. Best External Evidence:


From real clinical research among
intact patients.
Has a short doubling-time (10 years).
Replaces currently accepted diagnostic
tests and treatments with new ones that
are more powerful, more accurate, more
efficacious, and safer.

III. Patients Values &


Expectations
Have always played a central role in
determining whether and which
interventions take place
Were getting better at quantifying and
integrating them

What EBM is not:


EBM is not cook-book medicine
evidence needs extrapolation to my patients
unique biology and values

EBM is not cost-cutting medicine


when efficacy for my patient is paramount,
costs may rise, not fall

Five Steps of EvidenceBased Medicine


1. Ask an answerable clinical question
2. Search for the best evidence
3. Critically evaluate the evidence
4. Consider the evidence in terms of
clinical expertise and patients needs
5. Assess the feasibility of implementing
the evidence-based technologies
Sackett et al, 1996

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Evidence-Based Medicine:
The Practice
When caring for patients creates the need
for information:
1 Translation to an answerable question
(patient/manoeuvre/outcome).
2 Efficient track-down of the best evidence
secondary (pre-appraised) sources
Cochrane; E-B Journals
primary literature

e.g.,

Pyramid
Pyramid of
of evidence
evidence

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Evidence-Based Medicine:
The Practice
3 Critical appraisal of the evidence for its
validity and clinical applicability
generation of a 1-page summary.
4 Integration of that critical appraisal with
clinical expertise and the patients unique
biology and beliefs action.
5 Evaluation of ones performance.

Conclusions
Evidence-based medicine guarantees
freedom of decision making, if perceived
and applied correctly
Evidence-based medicine may significantly
influence the quality of healthcare if both
health professionals and health managers
use its principles correctly, and work as a
team
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Murray Enkin e al. A Guide to


Effective Care in Pregnancy
and Childbirth Oxford
University Press, 2000

http://www.childbirthconnection.org/article.asp?ck=10218

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What Is Unusual about This


Guide?
Provides synopses of contemporary approaches to
obstetric and neonatal care
All recommendation rest upon the results of
controlled trials and clinical experience
accumulated from the past century
Gives providers the necessary information to
ensure that practices are effective and they are not
harmful and unnecessary
Amended over 10 times and two new editions have
been published since 1989

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Guide Synopses
Table 1 Beneficial forms of care
Table 2 Forms of care that are likely to be
beneficial
Table 3 Forms of care with a trade-off between
beneficial and adverse effects
Table 4 Forms of care of unknown effectiveness
Table 5 Forms of care that are unlikely to be
beneficial
Table 6 Forms of care that are likely to be
ineffective or harmful

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Eminence based medicine

Eminence based medicine


The higher your colleagues position is, the less
he or she appreciates the value of something
as temporal as a scientific evidence
They believe that their personal experience is
worth any evidence. Such colleagues have a
moving faith in clinical experience defined as
making the same mistakes with growing
confidence during many yeas
Gray hair and a bald spot have the so-called
nimbus or halo effect

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Vehemence based medicine

Vehemence based medicine


Replacing evidence
with volume is an
effective technique to
win over more timid
colleagues and to
convince the patient in
your right
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Eloquence based medicine

Eloquence based medicine


All-the-year-round tan,
a buttonhole carnation,
a silk tie, an Armany
suit, and appropriate
language everything
evenly smooth. Stylish
clothes and eloquence
are powerful
substitutes of evidence

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Providence based medicine

Providence based medicine


When the doctor does not know what to
do next, the best solution will be to leave
the decision up to the Almighty.
Unfortunately, too many clinicians cannot
resist leaving the decision to Gods will.

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Diffidence based medicine


Difdence based medicine

Some doctors see the


problem and seek the
answer. Others see only the
problem. A diffident doctor
does not do anything out of
despair. Certainly, to some
extent it is better than doing
anything to uphold ones
reputation
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Nervousness based medicine


Nervousness based medicine

A fear of a lawsuit is a powerful motivation


for unnecessary tests and treatment. In
atmosphere of fearing lawsuits the only
test that does not come to mind, is the
obviously bad test

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Confidence based medicine


Confdence based medicine

Only for surgeons

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Effective Interventions with


Limited Implementation
Intervention

Result

Implementation

Corticosteroids for mother in


pre-term labour

Effective

Limited

Magnesium sulfate in eclampsia

Effective

Limited

Ambulation and vertical position


in the first stage of labour

Effective

Limited

Active management of the 3rd


stage of labour

Effective

Limited

Companion presence at birth

Effective

Rare

Rooming-in and early


breastfeeding

Effective

Rare
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Common Interventions with


Limited Effectiveness
Interventions

Expected result

Result

Routine electronic
foetal monitoring

Perinatal mortality

Limited

Routine echoscopy

Perinatal mortality

Routine episiotomy

Vaginal tears

No protection

Routine perineal
shaving

Infection prevention

No protection

Routine enema

Infection prevention

No protection

Many antenatal visits

Maternal morbidity
Low birth weight

Limited

Limited

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Clinical guidelines

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What are clinical guidelines?


Systematically developed statements to
assist practitioner and patient decisions
about appropriate healthcare for specific
clinical circumstances

Field & Lohr. Clinical practice guidelines: directions for a new program. 1990

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Why clinical guidelines?

Appropriateness of health care


Coping with information
Shared information and decision making
Risk management
Efficiency
Resource allocation

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The pathway
Topic selection
Group composition
Focusing questions
Finding the evidence
Appraisal of evidence
Forming recommendations
External review
Dissemination
Updates
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Did the guideline development group


encompass the right range of skills and
experience?

Specialist and sub-specialist


Primary care
Public health and epidemiology
Information
Health service management
Patient
Health economics
Any other stake-holder
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How was evidence identified and assessed?

Cochrane Library
Major databases, e.g. Medline, Embase
Secondary references
Grey literature
Colleagues and researchers

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A search strategy

Systematic reviews & meta-analyses


Randomised trials
Observational studies
Narrative reviews & expert opinion

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Clinical guidelines

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Qualit
y
rating
Qualit
y
rating

Evidenc
e tables
Considered
judgement

Graded
recommend
-ations

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Clinical guidelines

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How was evidence linked to


recommendations?
Quality, quantity and consistency of evidence
Costs versus benefits
Consensus within group

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Clinical guidelines

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