REVIEW ARTICLE
Evidence-Based Medicine: An Obstetrician and Gynaecologist’s Perspective
Talaulikar Vikram ● Nagarsekar Uday
Talaulikar V. [vtalauli@sgul.ac.uk], Department of Obstetrics and Gynaecology, St. George’s Hospital, Tooting, London SW17 0QT, UK
Nagarsekar U., Department of Obstetrics and Gynaecology, Apollo Victor Hospital, Margao, Goa 403601, India
Abstract
Objectives: Evidence based medicine (EBM) has transformed
the way healthcare is delivered all over the world.
It combines individual clinical expertise with best available
research evidence so that the patients get a high standard of
care. The growth of information technology has provided
us with tools which enable us to scrutinise vast amounts of
data within a very short amount of time. EBM is a lifelong
learning process and is an effort to make the most effective
use of medical knowledge for best outcomes in terms of
patient benefit and safety. It is important to understand the
basic concepts of EBM and practice as well as propagate
evidence based healthcare in Obstetrics and Gynaecology.
Conclusion: Obstetricians and Gynaecologists need to be
able to access and critically appraise the latest evidence in
their area of expertise and apply it in clinical practice to
provide best outcomes to women under their care.
Keywords : Evidence, Based, Medicine, Obstetrics, Gynaecology
Introduction
Over the last decade, the concept of evidence-based medicine
(EBM) has found a firm footing in the lives of clinicians
all over the world. The rise of EBM has accelerated
at an unprecedented pace more so because of the concurrent
advances in information technology. However, there
still appears to be ignorance as well as reluctance appear to
prevail upon many Obstetricians and Gynaecologists to
embrace this concept and inculcate it into their clinical
practice. In this article, we attempt to discuss what ‘Evidence-
based Obstetrics and Gynaecology’ exactly is, why
is it required, for whom is it meant and how is to be
practiced and propagated.
History
The EBM is believed to have originated from the times of
ancient Greek and Chinese medicine. However, its real
impact on the healthcare services has been felt mainly over
the last two decades. Professor Archie Cochrane, a Scottish
epidemiologist commented in 1972 about the failure of
Obstetricians and Gynaecologists to evaluate the effectiveness
of their services in the health care [1]. He also called for
up-to-date, systematic reviews of all relevant randomised
controlled trials (RCTs) of the health care in every specialty.
The Cochrane Collaboration, established in 1993, was an apt
response to his ideas of critical evaluation of healthcare
practices. The concepts of the methodologies used to obtain
the best evidence were established by the McMaster University
research group led by David Sackett and Gordon
Guyatt [1]. The term ‘evidence based’ was first used in 1990
by David Eddy [1–3], and the term ‘evidence-based medicine’
first appeared in the medical literature in 1992 in a
paper by Guyatt et al. [4].
What Does EBM mean?
EBM is defined as ‘the conscientious, explicit and judicious
use of current best evidence in making decisions about the
care of individual patients. The practice of EBM means
integrating individual clinical expertise with the best available
external clinical evidence from systematic research’ [5].
EBM brings together the best research evidence with clinical
expertise and individual patient’s values and circumstances.
Current best evidence is up-to-date information from
relevant, valid research about the effects of different forms
of health care, the potential for harm from exposure to
particular agents, the accuracy of diagnostic tests and the
predictive power of prognostic factors [6].
Individual clinical expertise refers to the proficiency and
judgment that individual clinicians acquire through clinical
experience and clinical practice. Increased expertise may
be reflected in many ways, but especially in more effective
and efficient diagnosis and in the more thoughtful identification
and compassionate use of individual patients’
predicaments, rights and preferences in making clinical
decisions about their care [5].
Individual clinical expertise and the best available
external research evidence are complementary tools, and
neither of them alone is enough. Unless there is adequate
clinical expertise, even the best of the external evidence
may become inapplicable or inappropriate for an individual
patient. At the same time, the lack of current best evidence
may make the practice out of date and run the risk of
causing harm to the patients. EBM continually seeks to
assess the strength of evidence of the risks and benefits of
treatments (or lack of treatment) and diagnostic tests.
Types of EBM
Two types of evidence-based practice have been proposed
[1, 2]:
- EBG: EBG is the practice of EBM at the organisational
or institutional level. This includes production
of guidelines, policies and regulations to be followed
by the healthcare staff.
- EBID making: EBID making is EBM as practiced by
the individual healthcare provider.
Why Do We Need EBM?
- With the ever-increasing pace of life and expanding
medical knowledge, keeping abreast with the latest
development in one’s own specialty has become a challenge.
In the busy clinical practice, it is estimated that
there is a need for valid information about specific clinical
problem regarding a patient up to five times every patient
admitted to the hospital [7] and two times for every three
patients in the outpatient’s clinic [8]. Over 2 million
articles are published annually in the biomedical literature
in more than 20,000 journals [9]. Do we have the time to
go through all the studies or papers published inObstetrics
and Gynaecology all over the world on daily or weekly
basis? The answer is definitely no.
Studies show that we cannot afford more than a few
seconds per patient for finding and assimilating evidence
or to set aside more than half an hour of study per week
[10–12].
In fact, it is estimated that to be able to keep oneself
abreast with the latest information in the literature in a
specialty like General Medicine, one would have to read
19 articles per day, 365 days per year [13]. It should not be
much different in our specialty with the explosion of the
medical literature, which has happened over the last few
years. What is needed therefore is a sound practice of
EBM, which includes quick and efficient search for valid
and relevant research for answering key clinical questions
and providing the best clinical care for the patient.
- There is a vast variation of practice between hospitals,
individual units/doctors within one hospital. How do
we then ensure uniform standards of care for each and
every patient, and how do we determine who does the
best for their patients and who does not? EBM helps
us set the uniform standards of care whereby all the
staff can adhere to evidence-based protocols/treatments
in their hospitals/units.
- Aggressive marketing of therapeutic agents or industry-
driven treatments have become a major concern in
healthcare settings. EBM has the potential to challenge
any such therapies or interventions which do
not benefit patients but indeed may lead to harm. In
simple words—‘If there is no evidence of health
benefit with an intervention/drug—it should not be
given outside research settings’.
- Patients have of late become demanding, and in
today’s era of increasing patient choice, one is
expected to answer their questions and offer them
the latest evidence on the proposed therapy as well as
alternative options. EBM thus keeps us to be on our
toes so that we can then offer the latest knowledge on
the subject of interest to the patient. In fact, it is our
duty towards our patients to ensure that they are well
informed about their condition or treatment. A good
doctor will always realise this and make efforts so
that he/she can offer the best available care for his/her
patients.
Arguments Against EBM
The mention of the words ‘evidence-based medicine’ often
invites mixed reactions from medical fraternity:
- Some specialists believe that they have already been
doing their best for their patients at all times and there
is nothing in their practice which needs a change. It is
also argued that there is, however, very little evidence
for majority of what we do in medicine and so EBM
may not be necessary.
- Others are worried that they will not know how to
search for, critically appraise, analyse and implement
the available evidence for the benefit of their patients.
- Some argue that EBM is a cookbook approach to
medicine, and so it may not take cognizance of
individual patient’s needs and circumstances [5].
- EBM has been viewed as a cost-cutting tool implemented
by the managers and administrative staff so as
to bring forth policies which favour their budgets.
This is not necessarily true, and in fact, EBM may
sometimes lead to increased healthcare costs while
ensuring that the patient’s receive the best of the
treatments [14].
- It is also common for many clinicians to claim that
they are too busy in their practice to spare any time
for review of their practice. Although it is appreciated
that clinical practice can get very busy especially in
developing countries with lack of resources, it is to be
borne in mind that where there is a will there is a way.
A clinician who wants the best for his patients and
wants to be up-to-date with modern medicine will
find time to keep himself abreast with developments
in his/her specialty. Studies have already shown that
dedicated teams of clinicians can effectively practice
EBM [15].
- In some situations, gold standard evidence may not be
available.
- The amount of resources needed to conduct large
randomised trials to obtain sufficient evidence is often
significant, and thus funding sources may ultimately
determine which therapies are subjected to review
and which are not.
- The quality of individual studies performed to obtain
evidence may vary, which therefore makes it difficult
to compare them and apply the results to general
population.
- All the evidences produced may not be made
accessible, and this may bias the results/effectiveness
of any particular approach or intervention [1].
Despite the above criticism, EBM has come here to stay.
It is one of the tools, which we need to gurantee the provision
of a safe, uniform and effective healthcare to our
patients.
The recent years have seen massive strides being made
in the field of information technology and the way we
handle electronic data. And this has provided a tremendous
impetus to the advent of EBM. Computers allow us to
search for evidence on a given topic in a fraction of seconds
(after having scanned through millions of articles!).
Evolution of various novel techniques and statistical
methods of analysis has also given us new insights into
how we analyse and critically interpret data. Systematic
reviews of the effects of healthcare have proven to be one
of the best techniques for the appraisal of effectiveness of
any intervention in the healthcare. We are fortunate today
in that a huge volume of work has been already completed
for us by bodies like Cochrane collaboration, who have
summed up the available evidence into systematic reviews
for easy reference.
Also, the creation of evidence-based journals and websites
which critically appraise and publish about 2 %
clinical articles which are valid and of immediate clinical
use can be viewed as a big boon for today’s clinicians [10].
How to Practice EBM?
- When faced with a clinical problem, the first step is to
frame the clinical question. This should reflect the
following.
- Which individual or group of patients is being
studied?
- What medical/surgical/other intervention is
under consideration? (Is it a drug/surgery/surgical
technique/test/any other intervention)
- What are the alternative interventions available?
- What is the result/outcome of intervention that
is being studied/compared.
- Second step is to search for evidence. (Described in
detail in the next subsection)
- Then, critically appraise the evidence obtained in terms
of its validity and applicability to the chosen population.
- Apply the evidence in clinical practice—unless you
implement the evidence in practice, the effort to find
it becomes useless.
At this point, it is important to mention that there
seems to be an inertia which has set into medical
practice with advancing age and experience. Any
change from routine practice may become very
difficult to incorporate especially when the evidence
tends to contradict the years of typical practice
adopted by senior colleagues.
- Finally, evaluate the effect of change in practice from
your intervention.
Searching for Evidence
There are various sources from which one can usually
garner evidence; however, not all of them are up-to-date
and effective. A good source should give us the systematic
reviews available on the topic covering all relevant specialties,
which should be easily accessible, comprehensible
and clinically relevant.
- Textbooks—are often out of date by the time they are
published. Their large volumes are too overwhelming
sometimes. They may be a very good source to
understand basic pathophysiology of a condition;
however, the may not give the best latest advice
regarding management of the same.
- Journals—peer-reviewed journals are better than
those featuring descriptive or expert reviews. Some
journals now only consider good quality Randomised
Controlled Trials (RCTs) for publication as evidence
in favour of or against any intervention as they are
gold standard evidence for either accepting or refuting
its efficacy.
- Guidelines—excellent evidence-based guidelines are
available from institutions like Royal College of
Obstetricians and Gynaecologists (RCOG-UK),
National Institute for Clinical Excellence (NICEUK)
and many more to guide safe and evidence-based
practice in Obstetrics and Gynaecology.
- Colleagues—they are a common source of answers
for us; however, they are not always accurate and
sometimes harmful. In fact, some clinicians may have
very good bedside manners, appear confident in
clinical judgement and technical skills, but this does
not guarantee that they have critically analysed
evidence supporting certain approach or technique
used by them.
- Senior faculty—may not always be accurate and upto-
date. In fact, in the hierarchy of evidence, statements
by the ‘medical expert’ are considered to be the
least valid form of evidence. All experts are now
expected to reference their statements to scientific
studies [1].
Experience accumulated over the years is invaluable but
higher experience does not necessarily mean greater
wisdom. Many clinicians keep perpetuating the same
mistakes. As they say: ‘Bad habits don’t die easily’.
One of the major hurdles facing acceptance of EBM is
that those who are senior, and in position of authority
often find it difficult to accept evidence contrary to their
opinion. Imagine a junior resident questioning the
decision by a senior colleague at bedside rounds based
on the latest evidence provided by systematic reviews in
a journal for a given intervention. Very few authorities
will yield to the arguments in such situation and offer to
change their practice based on the evidence provided.
The more seasoned the clinician, the harder it is to bring
about change in practice. One study revealed that there
seems to be a statistically and clinically significant
negative correlation between our knowledge of up-todate
care and the years elapsed since graduation [16].
- Internet search—this is the quickest, the most effective
and extensive method to search for evidence. The
clinical question that one has framed is typed as key
search words into any of the search engines such as
‘PubMed’ or ‘Google’, and one is presented with the
huge amounts of relevant literature within a fraction
of a seconds. To choose which studies out of the
given data is for the clinician to decide based on their
individual merits. A read through the various
abstracts of studies obtained may be helpful in
filtering out the final list of important studies from
which full texts need to be analysed.
Popular search databases or websites include
PubMed (www.ncbi.nlm.nih.gov/pubmed)
Ovid (ovidsp.ovid.com)
Cochrane (www.cochrane.org or www.thecochranelib
rary.com)
CDC (www.cdc.gov)
WHO (www.who.int)
ACP Journal club (www.acpjc.org)
NHS Evidence (www. evidence.nhs.uk)
Google scholar (scholar.google.com)
Web of Science/Knowledge (wok.mimas.ac.uk)
RCOG (www.rcog.org.uk/guidelines)
Levels of Evidence
The strongest evidence for therapeutic interventions is provided
by the systematic review of randomised, triple-blind,
placebo-controlled trials with allocation concealment and
complete follow-up involving a homogeneous patient population
and medical condition [1]. In contrast, case reports
and expert opinion have little value as proof because of the
placebo effect and the biases inherent in observation.
Some of the Systems used for Classification of Evidence
[1] are
- US Preventive Services Task Force
- Level I: Evidence obtained from at least one
properly designed randomised controlled trial.
- Level II-1: Evidence obtained from well-designed
controlled trials without randomisation.
- Level II-2: Evidence obtained from well-designed
cohort or case–control analytic studies, preferably
from more than one centre or research group.
- Level II-3: Evidence obtained from multiple time
series with or without the intervention. Dramatic
results in uncontrolled trials might also be regarded
as this type of evidence.
- Level III: Opinions of respected authorities, based
on clinical experience, descriptive studies or
reports of expert committees.
- National Health Service UK
- Level A: Consistent Randomised Controlled Clinical
Trial, cohort study, all or none (see note
below), clinical decision rule validated in different
populations.
- Level B: Consistent Retrospective Cohort, Exploratory
Cohort, Ecological Study, Outcomes
Research, case–control study or extrapolations
from level A studies.
- Level C: Case-series study or extrapolations from
level B studies.
- Level D: Expert opinion without explicit critical
appraisal, or based on physiology, bench research
or first principles.
Grading of Evidence and Recommendations
Grading of Evidence
- Ia: systematic review or meta-analysis of randomised
controlled trials;
- Ib: at least one randomised controlled trial;
- IIa: at least one well-designed controlled study without
randomisation;
- IIb: at least one well-designed quasi-experimental
study, such as a cohort study;
- III: well-designed non-experimental descriptive studies,
such as comparative studies, correlation studies, case–
control studies and case series; and
- IV: expert committee reports, opinions and/or clinical
experience of respected authorities
Grading of Recommendations
- A: based on hierarchy I evidence;
- B: based on hierarchy II evidence or extrapolated from
hierarchy I evidence;
- C: based on hierarchy III evidence or extrapolated from
hierarchy I or II evidence; and
- D: directly based on hierarchy IV evidence or extrapolated
from hierarchy I, II or III evidence
Systematic Reviews
High-quality systematic reviews are the ideal for establishing
evidence because the methodology is well organised
with minimal element of bias.
A systematic review gives details of methods of trial
collection, reasons for inclusion or exclusion of trials and
statistical methods of analysis. Systematic reviews often
feature meta-analyses of RCTs. Meta-analysis of RCTs
means combining small trials (with too small sample to
reach sufficient power) to give increased power and precision.
A systematic review thus demarcates irrelevant and
insignificant studies from critical studies. A typical large
systematic review involves several individuals over several
months with an editorial team and peer review and is
finally published in both electronic and hard copy versions.
Randomised Controlled Trials
True randomisation and concealment of allocation avoids
selection bias that handicaps observational studies. Randomised
Controlled Trials when they are well conducted
with sufficient power are the gold standard for establishing
evidence for efficacy of any intervention/drug. They can
evaluate interventions like therapy, preventive measures,
quality of life, economics, harm and etiology.
Cochrane Collaboration
The Cochrane Collaboration was established in 1993 and
named after Professor Archie Cochrane. It is an international,
non-profit, independent organisation established to
ensure that up-to-date, accurate information about the
effects of healthcare interventions is readily available
worldwide. The Cochrane Collaboration prepares Cochrane
Reviews (Systematic Reviews) and aims to update them
regularly with the latest scientific evidence. There are more
than 28,000 people working within The Cochrane Collaboration
across 100 countries [17]. The members of The
Cochrane Collaboration are organised into groups, known
as ‘entities’, of which there are five different types:
Cochrane Review Groups, Cochrane Centres, Methods
Groups, Fields and Networks and The Consumer Network.
Evidence-based Practice in Obstetrics and Gynaecology
Let us consider some examples in day-to-day practice
which any Obstetrician/Gynaecologist may encounter and
consider whether we follow evidence-based practice in
these situations:
- Management of preterm labour—The RCOG guidelines
[18] clearly state that it is reasonable not to use
tocolytic drugs, as there is no clear evidence that they
improve outcome. However, tocolysis should be
considered if the few days gained would be put to
good use, such as completing a course of corticosteroids
or in utero transfer (Rec. grade A). There is also
insufficient evidence for reaching any firm conclusions
about whether or not maintenance tocolytic
therapy following threatened-preterm labour is worthwhile.
Therefore, maintenance therapy cannot be
recommended for routine practice (Evidence level Ia).
However, many clinicians especially in developing
countries still continue to use oral tocolytics like
isoxsuprine or salbutamol week after week throughout
the pregnancy.
- Management of sever preeclampsia/eclampsia—
diuretics like furesamide as well as anticonvulsants
like phenytoin and diazepam are used as first-line
therapeutic agents by many Obstetricians. The evidence
[19], however, says that Atenolol, angiotensin
converting enzyme inhibitors, angiotensin receptorblocking
drugs and diuretics should be avoided for the
management of hypertension in this setting (Rec.
grade B). Magnesium sulphate is the drug of choice
for eclampsia and should be considered for women
with pre-eclampsia, for whom there is concern about
the risk of eclampsia. This is usually in the context of
severe pre-eclampsia once a delivery decision has
been made and in the immediate postpartum period
[19] (Rec grade A and Level 1a evidence).
- In spite of no conclusive evidence to back these
therapies, many clinicians all over the world routinely
prescribe empirical oral or injectable progesterone or
human chorionic gonadotrophin (hCG) as first trimester
pregnancy support. In patients with recurrent
miscarriage (RM), these therapies are abused even
more. Aggressive marketing from the pharmaceutical
industry adds to the pressure on the clinicians.
Cervical weakness may often be over diagnosed,
and needless cerclage may be performed many a time.
Although it is well known that investigations like
routine TORCH titers do not add any additional
information in the work up of asymptomatic RM
patients, they still continue to form a part of standard
blood tests in many clinics. The RCOG guidelines
[20] have the following to say: ‘there is insufficient
evidence to evaluate the effect of progesterone
supplementation in pregnancy to prevent a miscarriage’.
There is also insufficient evidence to evaluate
the effect of hCG in pregnancy to prevent miscarriage
(Rec. grade A, Evidence level Ia/Ib).
TORCH (toxoplasmosis, other [congenital syphilis and
viruses], rubella, cytomegalovirus and herpes simplex
virus) screening is unhelpful in the investigation of
recurrent miscarriage (Rec. grade C). Cervical cerclage
is associated with potential hazards related to the
surgery and the risk of stimulating uterine contractions
and hence, should only be considered in women who
are likely to benefit (Rec. grade B).
- Diagnosis of macrosomia (‘big baby’) or intrauterine
growth restriction (‘small baby’) solely by abdominal
palpation is often attempted by some clinicians. This
may even form the basis for decisions like early
induction of labour or caesarean section. However, a
review of evidence shows that abdominal palpation
has limited diagnostic accuracy to predict a small for
gestational age (SGA) fetus [21] (Rec. grade C).
Physical examination of the abdomen by inspection
and palpation detects as few as 30 % SGA foetuses.
Therefore, if SGA is suspected, it is necessary to
supplement abdominal palpation with ultrasound
biometric tests. Symphyseal fundal height (SFH)
measurement has limited diagnostic accuracy to
predict an SGA neonate [21] (Rec. grade B). There
is also no evidence to support induction of labour in
women without diabetes at term where the foetus is
thought to be macrosomic [22] (Evidence level Ia).
There are a number of evidence-based reviews that
have demonstrated that early induction of labour for
women with suspected foetal macrosomia who do not
have diabetes does not improve either maternal or
foetal outcome.
- The advent of the so-called nutraceutical industry has
fuelled the introduction of hundreds of drug combinations/
products (containing lycopene, vitamin C,
Vitamin E, minerals, etc.) which claim to provide
antioxidant benefits during pregnancy including prevention
of pre-eclampsia, IUGR and miscarriage.
Over eight multicentres randomised trials all over the
world have now failed to demonstrate any benefit
from these products, but their use continues unabated
[23].
- The failure to implement use of partogram in all
hospitals despite good evidence for their use as well
as diagnosis of cephalopelvic disproportion based on
clinical pelvimetry alone in primigravida patients
leading to high caesarean section rates are other
instances where EBM is lacking across our specialty.
The above listed factors are just a few glaring examples
showing how our clinical practice remains in need of much
improvement and evidence-based practice.
How Do We Teach and Propagate EBM ?
It is the duty of good clinicians to inculcate the culture of
EBM amongst the junior faculty and students. All incoming
students and house officers should be oriented in EBM.
Integration of evidence-based discussions into ward
rounds, clinical conferences, undergraduate teaching and
research workshops is one step forward. Resident doctors
should be encouraged to search, review and present the
literature for such presentations. Members of clinical teams
at various levels/stages in clinical training can collaborate
in sharing the searching and appraising tasks. Medical
knowledge has to be more practical rather than theoretical.
It has to emphasise scientific thinking rather than memory
output of crammed book knowledge.
A survey of residency programmes concluded that some of
the determinants of continuing high attendance at post graduate
journal clubs include teaching of critical appraisal skills and
emphasising the primary literature besides others [24, 25].
The faculty can set up regular email alerts from various
online journal websites which feed the latest published
studies/papers into their email accounts. In fact, a number
of courses, workshops and seminars to explain how to
teach and practice EBM are becoming available today.
It is important for the clinician to avoid falling into the
trap of unethical clinical practice with growing commercialisation
and development of medical industry. Pharmaceutical
companies as well as laboratories offer huge
incentives to push their products (drugs or investigative
tests which may not have a necessary evidence base) in a
competitive market. It is solely up to us as good clinicians
therefore to refrain from unethical practices and follow
what the evidence says is in the best interest of our patients.
EBM has its own demerits as well as benefits and can be
used appropriately or inappropriately. There is no point in
thrusting EBM on to anybody, as that would defeat its very
purpose in the first place. The interest for seeking evidence
and practicing EBM has to come from within and that may
take some time to develop.
EBM is a lifelong learning process and not something
that can be acquired over the short term. It is important to
remember that individual clinical expertise acquired
through years of experience and practice is invaluable. But
the same skills and expertise then need to be utilised in
applying the best evidence in patient care. EBM is not a
substitute for clinical skills/expertise. It is only an effort
toward giving up out-dated medical tests/therapies and
making the most effective use of medical knowledge for
the best outcomes in terms of patients’ benefit and safety.
We all should aspire to practice EBM. As new knowledge
is added to our specialty and new evidence arises, we have
to incorporate the relevant changes into our practice to stay
up-to-date with the latest techniques.
Conflicts of interest None of the authors have any conflicts of
interest to declare. No funding was received for this article.
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