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2007;9:181187

Education

Education Health technology

assessment in obstetrics and
gynaecology. Part 2: application
in practice
Authors Parveen Abedin / Jane Daniels / Khalid S Khan

Key content:
The process of health technology assessment (HTA) is demonstrated using two examples: a systematic review

and a clinical trial.

The HTA of anti-D prophylaxis for Rh-negative pregnant women was undertaken to inform a decision on
whether to introduce this intervention universally.
Using statistical methods to pool the results, it was calculated that the number needed to treat with antenatal
anti-D prophylaxis to avoid one case of sensitisation was 278.
The EVALUATE trial was designed to investigate differences in complication rates between laparoscopic and
abdominal hysterectomy and between laparoscopic and vaginal hysterectomy.
The laparoscopic procedure has a higher mean cost per quality-adjusted life year (QALY), but it scores
significantly higher on all the quality of life questionnaires. Ultimately, it will be the willingness of the National
Health Service to pay the extra cost per additional QALY that will decide whether it is adopted into routine
practice.

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.

Keywords anti-D prophylaxis / health technology assessment / hysterectomy /

randomised controlled trial / systematic review
Please cite this article as: Abedin P, Daniels J, Khan KS. Health technology assessment in obstetrics and gynaecology. Part 2: application in practice. The Obstetrician & Gynaecologist 2007;9:181187.

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)

Jane Daniels BSc MMedSci MSc

Senior Research Fellow and
Unit Co-ordinator
Birmingham Womens Hospital, UK

2007 Royal College of Obstetricians and Gynaecologists

Khalid S Khan MMed MRCOG

Professor of Obstetrics, Gynaecology and
Clinical Epidemiology
Birmingham Womens Hospital, UK

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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.

Routine antenatal anti-D

prophylaxis for rhesus-negative
women
Our first example is the HTA of routine antenatal
anti-D prophylaxis given to rhesus (Rh) negative
women.1 Haemolytic disease of the newborn results
from the transplacental passage of maternal
alloantibodies directed against fetal red cell
antigens inherited from the father. Ninety percent
of all cases of clinically significant haemolytic
disease of the newborn affect Rh-positive infants
born to Rh-negative mothers. Approximately 16%
of women in the UK are Rh-negative and in about
10% of pregnancies the mother is Rh-negative and

Box 1

Inclusion and exclusion criteria for

a systematic review of anti-D
prophylaxis for Rh-negative
pregnant women

182

Question formulation
(PICOS)
Study inclusion/exclusion criteria
P (Participants)

Rh-negative pregnant women

I (Interventions)

Routine antenatal anti-D administration

C (Comparator)

No treatment

O (Outcome)

Sensitisation rates among at-risk women

Adverse effects
Costs

S (Studies)

Systematic reviews
Randomised controlled trials
Non-randomised controlled trials
Economic evaluations

the fetus Rh-positive. Currently, it is estimated that

sensitisation occurs in 625 Rh-negative women per
year, leading to 30 fetal or neonatal losses. The
proposed service evaluated in the HTA report is the
routine offering of anti-D prophylaxis to all
pregnant women who are Rh-negative or to
Rh-negative primigravid women only. Intramuscular
anti-D immunoglobulin would be given at 28 and
34 weeks of gestation.
Search strategy
All the major databases were searched, including
MEDLINE, EMBASE, Best Evidence, CINAHL, the
Health Management Information Consortium
(HMIC), Science Citation Index, Cochrane
Database of Systematic Reviews (CDSR), Cochrane
Controlled Trials Register (CCTR) and the Centre
for Reviews and Dissemination (CRD) databases
(Database of Abstracts of Reviews of Effects
[DARE], the NHS Economic Evaluation Database
[NHS EED] and the Health Economic Evaluation
Database [HEED]). They were also searched for
current research and grey literature. See Box 1 for
inclusion and exclusion criteria.
Quality assessment
Conventional quality assessment scales were not
used in the review as there was insufficient detail to
discriminate between the studies.2 The groups in
the studies were assessed for similarity at baseline
for prognostic factors. The reason stated for this
was that there were differences in study design. This
would potentially have added bias to the results.
One way of avoiding bias would be to look at the
RCTs as one group in a subgroup analysis. This
could then be checked for quality assessment with
regard to the adequacy of randomisation and
intention-to-treat analysis. As the outcome was to
look at sensitisation rates, which is an objective
measure, blinding is not as important here as it
would be in a study where, for example, the
outcome is to look at pain scores or satisfaction
rates among participants. Results from this group
would be more reliable than from groups of other
study designs.
Studies identified
A total of 11 studies were identified, which consisted
of one RCT, one quasi-RCT, two before-and-after
studies, six non-randomised trials with historical or
geographical controls and one retrospective study.
They varied in terms of patient selection and dosage
regimens. Randomised controlled studies are ideal
for intervention studies, as long as they are robust in
their conduct and design. The authors, however, felt
the need to include non-randomised studies as the
dose used in the only proper RCT was lower than
the one currently felt to be appropriate. It was
found that the proportion of women sensitised in
the intervention arm was lower than in the control
arm in all of the studies. The difference varied
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Group 1
Group 2
Group 3

2007;9:181187

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)

between studies and this can be attributed to the

dose or the schedule used. In two of the studies,
34 weeks of gestation was too late for routine
prophylaxis.
Meta-analysis
As mentioned in Part 1 of this paper, meta-analysis
should only be done if the studies in a systematic
review are sufficiently homogenous. There are
various statistical tests of heterogeneity and these
should be used as a yardstick to ascertain whether
meta-analysis should be carried out. As a result of
the dosage schedule variation, the studies were
divided into three groups: in group 1, a dosage
regimen of anti-D 500 iu at 28 weeks and 34 weeks
of gestation was used in primigravidae; in group 2,
1 500 iu at 28 weeks of gestation was used in
primigravidae as well as multigravidae; and in
group 3, 500 iu was used at 28 weeks of gestation in
primigravidae. Tests for heterogeneity showed that
there were non-significant differences among the
three groups and, therefore, a meta-analysis was
undertaken (Table 1).
Pooling the data from the 11 studies, 0.5% of
women became sensitised in the intervention arms,
compared with 1.4% in the control arms. The
number needed to treat (the number of women
who needed to be treated for one to get benefit) to
avoid sensitisation was 278.
Economic analysis
An evaluation of the costs and cost effectiveness
relevant to the NHS of providing routine anti-D
prophylaxis to Rh-negative pregnant women was
done. Before starting such an analysis, it is
important to define meaningful endpoints and
then decide, after reviewing the available literature,
whether modelling techniques are necessary. The
endpoints assessed in this evaluation were:

the cost per fetal loss/stillbirth/neonatal or

post-neonatal death avoided
the cost per life year gained
the number of disabilities avoided
the cost per quality-adjusted life year (QALY).
Eight previous economic evaluations were found
after searching the literature.39 These included
costbenefit analysis, cost-effectiveness studies and
studies using decision analytic modelling. A costeffectiveness evaluation was then modelled of
offering routine anti-D prophylaxis to all pregnant
women who are Rh-negative and to primigravid
Rh-negative pregnant women, in addition to the
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Education

Table 1

Results of the meta-analysis

conventional antenatal anti-D prophylaxis used by

the NHS.
It is important to consider all costs incurred in a
cost-effectiveness study. The main considerations
here are the costs incurred through providing
anti-D immunoglobulin and administering the
treatment (Box 2). As this study was undertaken
from an NHS perspective, costs to women of travel
and taking time off work were not accounted for.
The economic benefits of the programme are the
direct savings as a result of avoidance of
sensitisation in future pregnancies.
The authors estimated that the incremental cost per
prevented case of RhD haemolytic disease of the
newborn of the 2  500 dose has a central estimate
of 15,241 when treating primigravidae and 48,225
when all Rh-negative women are treated. For the 2 
1 250 iu dose, the incremental cost per case prevented
was estimated to be 13,618 for primigravidae and
43,407 for all Rh-negative women.
The gross annual cost of offering routine anti-D
prophylaxis to all Rh-negative pregnant women in
England and Wales is estimated to be 6.1 million for
the 2  1 250 iu regimen and 6.8 million for the
2  500 iu regimen. If routine anti-D prophylaxis
were to be offered to Rh-negative primigravid
women only, the cost of drugs would be
approximately 2.1 million for the 2  1 250 iu
regimen and 2.4 million for the 2  500 iu regimen.
The cost per QALY was then calculated on the basis
of the published literature relating to the impact on
quality of life of long-term neurodevelopmental
problems in low birthweight infants. It was found
that routine anti-D prophylaxis given to all
Parameters

Value

Box 2

Average life expectancy

74 years

Baseline parameters for the

evaluation of cost effectiveness

Sensitisation rate with no routine AADP

0.95%

Sensitisation rate with routine AADP

0.35%

Odds ratio

37.00%

Fetal loss rate per woman at risk under

current services*

0.04%

Current service provision of routine AADP

12.00%

Cost of AADP
2  500 iu
2  1 250 iu

54.00
47.80

Cost of administration

10.00

Economic savings per affected pregnancy

avoided

1,442.00

*Including stillbirths, neonatal and post-neonatal deaths

AADP = antenatal anti-D prophylaxis

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pregnant Rh-negative women is economically

beneficial, with a maximum cost-effectiveness ratio
of 30,000 per QALY, if the loss of a child, associated
parental grief and subsequent high intervention
pregnancies are valued at more than nine QALYs.
Routine anti-D prophylaxis has now been
introduced as standard practice in the NHS.11

Selection of women for

laparoscopically assisted
hysterectomy
The second HTA is from the field of gynaecology.
The example chosen deals with the route of
hysterectomy. Generally, women who undergo
abdominal hysterectomy spend at least 45 days in
hospital and have a slightly longer recovery period
than those undergoing vaginal hysterectomy.
However, it may not be technically possible to carry
out vaginal hysterectomy on all women and this is
Box 3

Inclusion criteria for eligibility for

randomisation

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

The Obstetrician & Gynaecologist

where laparoscopically assisted vaginal

hysterectomy has a place.
The EVALUATE trial12 was designed to test the null
hypothesis of no significant difference between
laparoscopic and abdominal hysterectomy and
between laparoscopic and vaginal hysterectomy
with regard to each of the outcome measures. An
economic evaluation was also carried out regarding
the costs and cost effectiveness to the NHS.
Trial design
Two parallel, concurrently conducted, multi-centre
randomised trials were designed. In one, the
abdominal trial, laparoscopic hysterectomy was
compared with abdominal hysterectomy. In the
other, the vaginal trial, laparoscopic hysterectomy
was compared with vaginal hysterectomy.
There were broad inclusion criteria for eligibility
for randomisation (see Box 3). However, the
exclusion criteria listed considerably narrowed the
conclusions that can be drawn from the study, as
many cases that would normally warrant surgery
(such as a bulky fibroid uterus) were excluded. This
calls into question the external validity of the study.
An added source of selection bias was introduced
by consultants being able to decide ultimately
whether women were unsuitable for inclusion.

Malignancy of the genital tract

Uterine prolapse
Uterine size 12 weeks
Medical illness preventing laparoscopy
Bladder or pelvic support surgery required
Women deemed unsuitable for randomisation by the
consultant
Refusal of consent

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

Imbalanced randomisation for

the study12

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conversion rate from laparoscopic to open surgery

and to ensure that surgeons, if not already at the
top of their learning curve, gained as much
experience of laparoscopic surgery as quickly as
possible.
Trial objectives
The primary objective was to record the number of
occurrences of a major complication or death. The
following were counted as major complications:

major haemorrhage
haematoma
bowel/ureteric/bladder injury
pulmonary embolus
major anaesthetic complications
wound dehiscence
unintended laparotomy.
The following parameters were determined:

pain assessment: visual analogue scale/opiate

requirements
sexual activity: initial visit, 6 weeks, 4 months and
1 year

body image
health status: using the SF-12 Health Survey
questionnaire and the EQ-5D.

Benign conditions such as menorrhagia can be

distressing and disabling. The key objective of
treatment is to improve quality of life. Any trial
to discover the effect of an intervention should
focus on assessing improvement of the original
condition. In our opinion, the primary outcome in
this study should be health status, rather than
complications. If complications occur they reflect
on health status measurement, thereby having an
impact on the outcome of hysterectomy. The
occurrence of any major complication is a
composite outcome measure that is usually viewed
with scepticism and suspicion in clinical trials, as it
invalidates inferences about effectiveness.13 This
composite outcome measure has another key
problem: it cannot be symmetrically applied
to the various trial arms. For example, abdominal
hysterectomy cannot have unintended laparotomy
as a complication. If laparotomy were to be
considered an undesirable outcome, all of the
women allocated to abdominal hysterectomy
would inevitably be recorded as having suffered
this outcome. Conversion to laparotomy in
laparoscopic hysterectomy can only be considered
a surgical complication in light of the reason for
conversion (for example, uncontrollable bleeding).
The woman should be informed and have
consented to the possibility of such unintended
open surgery being a necessary part of laparoscopy.
These concerns have been highlighted in a number
of published commentaries and need to be
considered in our interpretation.14
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It is not uncommon for good trials comparing

laparoscopic with open procedures to report data
on a primary outcome of key interest to wellbeing
and complication rates as secondary outcomes. For
example, a trial compared laparoscopically assisted
versus open colectomy for colon cancer, with the
time to tumour recurrence as the primary outcome
measure.15 The recurrence rate was found to be
similar between the two study groups. Here, there is
clear information on effectiveness.
Statistical considerations
Sample size
In any study of this kind, it is important to establish
the sample size required to detect a statistically
significant difference at the protocol stage. In the
abdominal versus laparoscopic hysterectomy arm of
the trial, it was expected that 9% of women
undergoing abdominal hysterectomy would have
major complications. If an incidence of 4.5% of
complications was to be observed in the laparoscopic
hysterectomy group, a difference of 50% between the
two groups, a clinically relevant outcome would be
demonstrated. To do this, a total sample size of 487
women per trial arm would be needed, using 80%
power and a two-sided type I error rate of 5%.
Similarly, a complication rate of 4% was expected in
the vaginal hysterectomy arm of the trial. If the
laparoscopic hysterectomy complication rate was
2%, a difference of 50% between the two groups
would be detected: again, a clinically relevant
difference. To detect this difference, a sample size of
1 141 women per trial arm was required, using 80%
power and a 5% error rate.
Keeping the imbalanced randomisation rate of
2:1 (laparoscopic: abdominal hysterectomy and
laparoscopic: vaginal hysterectomy) for reasons
mentioned above, the number of women
undergoing hysterectomy was planned at 1 800:
1 048 for the abdominal and 752 for the vaginal trial.
In the abdominal arm of the trial, it was planned that
349 women would have abdominal hysterectomy
and 699 assisted laparoscopic hysterectomy. Out of
the women in the vaginal trial, it was planned to
recruit 501 to the vaginal laparoscopic hysterectomy
arm and 251 to the vaginal hysterectomy arm of the
trial. In fact, only 1 380 women were recruited in
total: 292 to abdominal hysterectomy, 584 to assisted
laparoscopic hysterectomy, 168 to vaginal
hysterectomy and 336 to vaginal laparoscopic
hysterectomy. Fifty-one surgeons had agreed to
participate in the trial but only 43 surgeons actually
recruited women.
Intention-to-treat analysis
One of the methods of avoiding attrition bias is to
analyse patient data according to the type of
operation to which they were initially randomised,
irrespective of whether they underwent it or not.
This was done in the trial.
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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.

previous pelvic surgery

uterine descent
uterine size
uterine mobility
palpable endometriosis
vaginal capacity.
However, only previous pelvic surgery was found to
influence the rate.
Laparoscopic hysterectomy
The variables thought to influence the major
complication rates were:

previous pelvic surgery

uterine size
uterine descent
uterine mobility
palpable endometriosis
vaginal capacity
size of the trocars used
number of abdominal incisions
type of laparoscopic incision
haemostasis of the ovarian and uterine pedicles
maximum intra-operative carbon dioxide (CO )
2

pressure.

A non-significantly higher rate of complications

occurred in procedures where the larger 12 mm
trocar was used. The bipolar method of securing
haemostasis on the ovarian pedicle resulted in 8.6%
of women having major complications, compared
with 35.3% of women where the suturing method
was used. This accounted for 25% of all major
complications for laparoscopic hysterectomy.
Uterine descent and haemostasis of both the
uterine and ovarian pedicles are significantly
important variables in the prediction of major
complications.
Economic evaluation
A cost-effectiveness analysis was carried out in
which the various routes of hysterectomy were

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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compared. In the comparison of laparoscopic and

vaginal hysterectomy, the mean cost per woman
(401) and QALY (0.0015) was higher in the
former. The incremental cost-effectiveness ratio
(ICER), the mean difference in costs divided by the
mean difference in QALYs, was 267,333.
When laparoscopic and abdominal hysterectomy
were compared, the laparoscopic procedure had a
higher mean cost (186) and higher mean QALY
per woman (0.007). This generated an ICER of
26,571. Compared with vaginal and abdominal
procedures, laparoscopic hysterectomy resulted in a
higher mean time in the operating theatre and
more extensive use of disposable instruments. This
was, however, offset by a shorter mean hospital stay
compared with abdominal hysterectomy.
Ultimately, it is the willingness of the NHS to pay the
extra cost per additional QALY that will decide
whether the laparoscopic route is adopted for
hysterectomy. In terms of QALYs, there was little
difference between laparoscopic and abdominal or
vaginal hysterectomy.Vaginal hysterectomy appears
to be more cost effective than laparoscopic
hysterectomy, but cost effectiveness of the
laparoscopic approach relative to abdominal
hysterectomy was finely balanced. This HTA
reminds us that hysterectomy complications are
common, whatever the route. As such, training is an
important issue, as the higher complication rate
observed with laparoscopic hysterectomy can be
considered to be the result of a learning curve effect.

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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and funding the most clinically effective and

economically efficient health technologies. An
amalgamation of all the information gathered on
clinical effectiveness and cost effectiveness goes into
the making of an HTA. This information is then
scrutinised by policy makers as well as patient
representatives and, finally, incorporated into
practice.
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