1
the review incorporated the qualitative data analysis that accompanied 3 of these trials. This data
2
describes women’s experience of care and their emotional response to early pregnancy loss and its
3
management. These findings are reported in separate summary tables within the relevant chapter and
4
quotations used to illustrate the key themes identified (see tables 7.3 and 7.5).
5
In order to make explicit the GDG’s consideration of women’s psychological support when making
6
recommendations a separate sub-section has been created within the evidence to recommendations
7
section for each review. Summaries here will link the evidence from the systematic review, the GDG’s
8
interpretation of the evidence and their own clinical experience with recommendations aimed at
9
improving psychological support for women.
10
Using these methods recommendations for emotional and psychological support will be integral to the
11
guideline, featuring in each chapter as appropriate in addition to the specific chapter where this is
12
addressed directly. In this way the GDG wanted to underline that this essential component of care
13
needs to be provided for all women alongside clinical care and treatment in a way that is appropriate
14
to each woman’s circumstances.
15
Recommendations aimed at improving women’s emotional and psychological support during the initial
16
phases of care for pain and bleeding in early pregnancy include the provision of comprehensive
17
information, both verbal and written, so that women know what to expect during the process of their
18
care and what symptoms should prompt urgent return, written provision of a contact telephone
19
number and details of where a women can access additional ongoing support. Training in sensitive
20
communication and breaking bad news for staff working in a dedicated early pregnancy service is
21
recommended. There is also a recommendation to ensure that sufficient time is spent in consultations
22
so that issues can be discussed and provision made for an additional appointment to ensure this can
23
be done adequately. In addition, all women presenting with pain and bleeding in early pregnancy
24
should be offered the opportunity to return for a follow-up appointment in either primary or secondary
25
care, whichever the woman prefers. The guideline recommends that a dedicated early pregnancy
26
service should be available for women with pain and bleeding in early pregnancy as the GDG
27
believed this provision would improve both clinical and psychological care for women and would mean
28
women with early pregnancy complications would no longer need to be cared for on general
29
gynaecology wards or antenatal wards. The guideline also recommends that women who have had a
30
previous ectopic pregnancy should be able to self-refer directly into a dedicated early pregnancy
31
service in order to provide these women with the reassurance of quick, easy access to a specialist
32
service. Similarly, provision is made for women with previous adverse or traumatic experience
33
associated with pregnancy to be able to opt for active management of miscarriage if that is their
34
preference. The importance of women’s choice is also highlighted throughout the guideline including a
35
choice of method of management of miscarriage when expectant management is not successful, a
36
choice of abdominal ultrasound where tranvaginal ultrasound is not acceptable and the choice of
37
surgical treatment for ectopic pregnancy where this is preferred over medical treatment.
38
A summary of the recommendations for information-giving and psychological support appears
39
towards the beginning of the care pathway in order to highlight its significance, simplify the pathway
40
and to avoid repetition. However, symbols are used throughout the care pathway to illustrate where
41
further specific information should be provided in order to highlight that this is essential throughout all
42
stages of care.
43
3.5
Incorporating health economics
44
The aims of the health economic input to the guideline were to inform the GDG of potential economic
45
issues relating to pain and bleeding in early pregnancy, and to ensure that recommendations
46
represented a cost effective use of healthcare resources. Health economic evaluations aim to
47
integrate data on benefits (ideally in terms of quality adjusted life years [QALYs]), harms and costs of
48
different care options.
49
The GDG prioritised a number of review questions where it was thought that economic considerations
50
would be particularly important in formulating recommendations. Systematic searches for published
51
economic evidence were undertaken for these questions. For economic evaluations, no standard
52
system of grading the quality of evidence exists and included papers were assessed using a quality
53
assessment checklist based on good practice in economic evaluation. Reviews of the (very limited)
1
relevant published health economic literature are presented alongside the clinical effectiveness
2
reviews.
3
Health economic considerations were aided by original economic analysis undertaken as part of the
4
development process. For this guideline the areas prioritised for economic analysis were as follows:
5
Expectant compared with active management of miscarriage
6
Management of ectopic pregnancy
7
Progesterone for treatment of threatened miscarriage
8
Effectiveness of early pregnancy assessment units (EPAUs)
9
It should be noted that, due to a lack of relevant health economic literature and absence of clinical
10
effectiveness data, it was not possible to undertake economic analysis to determine the cost
11
effectiveness of EPAUs.
12
3.6
Evidence to recommendations
13
For each review question recommendations for clinical care were derived using, and linked explicitly
14
to, the evidence that supported them. In the first instance, the technical team drafted and the GDG
15
agreed short clinical and, where appropriate, cost effectiveness evidence statements which were
16
presented alongside the evidence profiles. Statements summarising the GDG’s interpretation of the
17
evidence and any extrapolation from the evidence used to form recommendations were also prepared
18
to ensure transparency in the decision-making process. The criteria used in moving from evidence to
19
recommendations were as follows:
20
Relative value placed on the outcomes considered
21
Consideration of the clinical benefits and harms
22
Consideration of net health benefits and resource use
23
Quality of the evidence
24
Information giving and psychological support
25
Other considerations (including equalities issues)
26
In areas where no substantial clinical research evidence was identified, the GDG considered other
27
evidence-based guidelines and consensus statements or used their collective experience to identify
28
good practice. The health economics justification in areas of the guideline where the use of NHS
29
resources (interventions) was considered was based on GDG consensus in relation to the likely cost
30
effectiveness implications of the recommendations. The GDG also identified areas where evidence to
31
answer their review questions was lacking and used this information to formulate recommendations
32
for future research.
33
Towards the end of the guideline development process formal consensus methods were used to
34
consider all the clinical care recommendations and research recommendations that had been drafted
35
previously. The GDG identified 8 ‘key priorities for implementation’ (key recommendations) and five
36
high-priority research recommendations. The key priorities for implementation were those
37
recommendations thought likely to have the biggest impact on the care of women with pain and
38
bleeding in early pregnancy and outcomes in the NHS as a whole; they were selected using two
39
rounds of anonymous voting amongst the GDG members. In the first round of voting each member
40
was asked to cast 10 votes and the five recommendations that received six or more votes were
41
promoted to become key priorities for implementation. A second round of voting was carried out for all
42
recommendations that received between three and five votes in the first round. Each GDG member
43
was asked to cast five votes. A further three recommendations received six or more votes in the
44
second round and were added to the list of key priority recommendations. The priority research
45
recommendations were selected in a similar way, with one round of voting leading to selection of five
46
key priority recommendations for research.
47
Pain and bleeding in early pregnancy
32
3.7
Stakeholder involvement
1
Registered stakeholder organisations were invited to comment on the draft scope and the draft
2
guideline.
3
[There will be more text to add here following stakeholder consultation]
4
4 Psychological support
1
4.1
Introduction
2
Becoming pregnant carries considerable psychological as well as physical and social significance. A
3
miscarriage is a physical loss but it also represents the loss of a potential relationship and, for some,
4
the loss of a potential new role. Many women will adjust without distress but some experience
5
considerable anxiety and sadness akin to grief following other important losses. In a minority the
6
miscarriage may precipitate psychological disorder such as anxiety or depression. Pain and bleeding
7
in early pregnancy may be also be distressing if it brings anxiety about the health and viability of the
8
pregnancy even if it does not end with miscarriage. In addition the experience of the early pregnancy
9
loss, especially if sudden or life-threatening, may generate symptoms associated with traumatic
10
stress. This is particularly relevant following ectopic pregnancy.
11
Pregnancy loss is not just about physical recovery and being ready to become pregnant again. The
12
GDG consider that good care includes sensitivity to the psychological impact of miscarriage. Even if
13
women have no extra psychological morbidity following the miscarriage they do express views about
14
what constitutes good care and preferences about how the condition should be managed to enhance
15
their recovery.
16
The GDG looked at the literature to determine if there were acceptable studies of interventions to
17
improve women’s psychological adjustment after early pregnancy loss. The group also looked at
18
qualitative work which reported women’s preferences about their care.