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HTA ObsGyn Laparos
HTA ObsGyn Laparos
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10.1576/toag.9.3.181.27339 www.rcog.org.uk/togonline
2007;9:181187
Education
Key content:
The process of health technology assessment (HTA) is demonstrated using two examples: a systematic review
Learning objectives:
To understand, through examples, the practical application of the process of HTA in everyday clinical practice.
To appreciate the incorporation of clinical and economic evaluations into assessment of effectiveness.
To understand the quality criteria for assessing primary studies in a systematic review.
Ethical issues:
It is no longer sufficient to consider only the clinical effectiveness of a technology. HTA should include an
economic evaluation to determine value for money.
Systematic reviews provide evidence of effectiveness, although implementation of a technology will depend on
its relative importance to policy decision makers.
Researchers need to be transparent in any shortcomings in the design or conduct of their trials and reviews.
Author details
Parveen Abedin MSc MRCOG
Locum Consultant Obstetrician and
Gynaecologist
Good Hope Hospital, Rectory Road,
Sutton Coldfield, Birmingham B75 7RR, UK
Email: Pabedin@doctors.org.uk
(corresponding author)
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Introduction
In Part 1 of this article an overview was presented of
the process of health technology assessment (HTA).
Its use by agencies such as the National Institute for
Health and Clinical Excellence (NICE) in deciding
on the most clinically effective and cost efficient
technology for the National Health Service (NHS)
was discussed. Information was given on systematic
reviews, randomised controlled trials (RCTs) and
economic evaluations. Where, though, does all this
fit into our specialty?
As clinicians, we are faced every day with making
decisions about the optimal care for women with
regard to effectiveness and cost. HTAs are
increasingly being used to incorporate the most
clinically and cost-effective evidence-based
methods into our clinical practice. An example is
the increasing use of early pregnancy assessment
units to diagnose early pregnancy problems, such
as miscarriage and ectopic pregnancy. Women
spend a minimum of time as inpatients, thus
cutting down on hotel costs, while being managed
primarily by advanced nurse practitioners with
access to medical expertise if needed. Another
example is the community antenatal care of lowrisk women. Hospital and travel costs to women are
cut down, while there is continuity of care from
community midwives.
The process of HTA in obstetrics and gynaecology
is demonstrated by the examples given here.
Box 1
182
Question formulation
(PICOS)
Study inclusion/exclusion criteria
P (Participants)
I (Interventions)
C (Comparator)
No treatment
O (Outcome)
S (Studies)
Systematic reviews
Randomised controlled trials
Non-randomised controlled trials
Economic evaluations
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Group 1
Group 2
Group 3
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Test for
heterogeneity
Odds ratio of
sensitisation with antenatal
prophylaxis (95% CI)
Sensitisation rate
of control group
(% [95% CI])
Sensitisation rate of
antenatal prophylaxis
group using metaanalysis (% [95% CI])
0.812
0.940
0.976
0.33 (0.200.55)
0.20 (0.130.29)
0.37 (0.210.65)
0.89 (0.211.56)
1.60 (0.372.83)
0.95 (0.181.71)
0.30 (0.220.38)
0.34 (0.280.40)
0.35 (0.290.40)
Education
Table 1
Value
Box 2
74 years
0.95%
0.35%
Odds ratio
37.00%
0.04%
12.00%
Cost of AADP
2 500 iu
2 1 250 iu
54.00
47.80
Cost of administration
10.00
1,442.00
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Inclusion criteria
Women with gynaecological symptoms who needed
hysterectomy
Women who gave informed consent
Failed medical or conservative treatment such as
endometrial ablation
Exclusion criteria
Randomisation
Women were selected for inclusion to the vaginal
or abdominal trial as decided by the treating
gynaecologist. Computer-generated randomisation
was done. Imbalanced randomisation was chosen
in favour of laparoscopic hysterectomy in a ratio of
1:2 (Figure 1). This was to allow for the 23%
Figure 1
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major haemorrhage
haematoma
bowel/ureteric/bladder injury
pulmonary embolus
major anaesthetic complications
wound dehiscence
unintended laparotomy.
The following parameters were determined:
body image
health status: using the SF-12 Health Survey
questionnaire and the EQ-5D.
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Results
(See Table 2)
Quality of life results
Quality of life (QOL) was measured using the
SF-12 Health Survey Questionnaire, Body
Image Scale (BIS) questionnaire, Sexual Activity
Questionnaire (SAQ) and the EuroQoL
instrument (EQ-5D).
A highly significant statistical difference was found
in the SF-12 physical component summary score,
the BIS score, the SAQ score and the EQ-5D score
between abdominal hysterectomy and
laparoscopically assisted vaginal hysterectomy, in
favour of the latter.
Major complications
The assisted laparoscopic hysterectomy procedure
had a statistically significantly higher major
complication rate than abdominal hysterectomy.
There was no significant difference in the rate of
major complications between the vaginal and
vaginal laparoscopic hysterectomy procedures.
Major complications tended to happen before
discharge from hospital.
A statistical method of analysis called logistic
regression is used to identify any variables that can
influence the outcome of a trial. Logistic regression
was used here to identify variables that can
influence the likelihood of a major complication.
Abdominal hysterectomy
The variables thought to be important in the
prediction of a major complication in abdominal
hysterectomy were:
type of incision
previous pelvic surgery
uterine mobility
vaginal capacity
palpable endometriosis
uterine descent
uterine size.
However, none of these variables were found to be
important predictors.
pressure.
Abdominal
Table 2
Major complications of
hysterectomy by route12
Vaginal hysterectomy
The following were thought to be important in
influencing the rate of major complications in
women having vaginal hysterectomy:
Outcomes
Quality of life
Major haemorrhage
Bowel injury
Ureteric injury
Bladder injury
Pulmonary embolus
Anaesthetic problems
Unintended laparotomy
Intra-operative conversion
Return to operating theatre
Wound dehiscence
Haematoma
Other complications
Vaginal
AH (%)
ALH (%)
VH (%)
VLH (%)
7 (2.4)
3 (1.0)
0 (0)
3 (1.0)
2 (0.7)
0 (0.0)
27 (4.6)
1 (0.2)
5 (0.9)
15 (2.1)
1 (0.2)
5 (0.9)
5 (2.9)
0 (0.0)
0 (0.0)
2 (1.2)
0 (0.0)
0 (0.0)
17 (5.1)
0 (0.0)
1 (0.3)
3 (0.9)
2 (0.6)
2 (0.6)
1 (0.3)
1 (0.3)
1 (0.3)
2 (0.7)
0 (0.0)
23 (3.9)
3 (1.0)
1 (0.2)
4 (0.9)
0 (0.0)
7 (4.2)
0 (0.0)
0 (0.0)
2 (1.2)
1 (0.6)
9 (2.7)
1 (0.3)
1 (0.3)
7 (2.1)
0 (0.0)
AH = abdominal hysterectomy; ALH = assisted laparoscopic hysterectomy; VH = vaginal hysterectomy; VLH = vaginal laparoscopic hysterectomy
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Conclusion
Health technology assessment, such as in the two
examples illustrated, is playing an increasing role in
ensuring that evidence-based methods dictate
clinical practice. HTAs of topics of relevance are
commissioned by governmental bodies, such as
NICE, to direct health policy makers in approving
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