RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Making decisions: Should I take
hormone replacement therapy?
Final Report on Focus Testing for the
National Health and Medical Research Council
RFT 063/0304
Investigators: Lyndal Trevena, Kirsten McCaffery,
Alex Barratt,
Bruce Armstrong, Annette O’Connor,
Sydney Health Decision Group
School of Public Health
University of Sydney
November 2004
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Sydney Health Decision Group: HRT Decision Aid
Acknowledgements
We would like to thank Dr Judith Clarke, Mary Lewicka and Sadhana Rajur for
their work on the development of the decision aid and their assistance with the
focus testing. We would also like to thank the women and practitioners who
generously gave up their time to participate in focus groups and telephone
interviews. For reasons of confidentiality their names and organisations are not
listed here. However, we are extremely grateful for their support. Finally we
would like to thank focus group facilitators (Katherine Stevenson, Natasha
Nassar) and community group organisers (Kim Mooney, Helen Pollincini,
Maria Vaccari, Edit Melgarejo) for their invaluable assistance in setting up and
running the focus groups.
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Contents
Executive Summary……………………………………………………………….4
Project objectives and design……………………………………………………...5
Study 1 ……………………………………………………………………………7
Study 2…………………………………………………………………………….10
Study 3……………………………………………………………………………21
Appendices………………………………………………………………………..27
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Sydney Health Decision Group: HRT Decision Aid
EXECUTIVE SUMMARY
Background
In March 2004, the Sydney Health Decision Group, University of Sydney, commenced a
contract for the development and focus testing of a decision tool for women considering HRT
for the relief of menopausal symptoms. The aim of the project was (a) to develop a decision
aid for HRT suitable for Australian women and (b) to conduct a preliminary qualitative
evaluation and refine the decision aid through focus testing with a culturally diverse sample
of Australian women and health practitioners working with menopausal women. The decision
aid, along with a summary of evidence and an information booklet were commissioned by the
NHMRC in response to the results of the Women’s Health Initiative (WHI) study. This report
describes the methods and results of practitioner and consumer focus testing under the
NHMRC contract.
Method
The focus testing consisted of three parts 1) Convenience testing of the first decision aid draft
(n=12); 2) Ten focus groups with women aged 40-65 years from a range of socioeconomic
and ethnic backgrounds (n=51). These included interviews with women of Italian, Greek,
Lebanese, European and Indigenous Australian backgrounds; 3) Eight practitioners across a
range of backgrounds (gender, general practice, menopause specialist, nurse practitioner)
Results
Overall, consumers and practitioners were very positive about the decision aid. They found it
contained about the right amount of information and was easy to understand. Consumers
perceived the information to be balanced and fair, of very high quality and were positive
about its strong evidence-base. Practitioners were also appreciative of the quality but did not
think consumers would value this. Consumers appreciated the clear representation of benefits
and risks using probabilistic graphical displays and found the weigh-scales helpful.
Practitioners particularly liked the possibility of consumers reviewing the information outside
the consultation and both parties thought it would promote a more shared approach to
decision-making. The decision aid was acceptable to the whole range of socioeconomic and
cultural women interviewed.
Conclusions and recommendations
The decision aid is highly acceptable, clear and helpful to Australian women from a range of
socioeconomic and ethnic backgrounds. Its strong evidence-base and format were valued by
both practitioners and consumers and is likely to promote shared decision making in practice.
The NHMRC will need to include approved information sources and appropriate pictures
following the final public consultation process.
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Sydney Health Decision Group: HRT Decision Aid
Making Decisions: Should I take hormone replacement therapy?
Final Report on Focus Testing of a decision aid for women considering HRT
PROJECT OBJECTIVES AND DESIGN
1. Background
Following the release of the Women’s Health Initiative (WHI) results in 2002,
recommendations on the use of hormone replacement therapy (HRT) changed
substantially. In August 2003 the Australian Drug Evaluation Committee (ADEC)
recommended that ‘the use of HRT for any long term disease prevention cannot be
generally justified as the potential harm may outweigh potential benefits’.
However, HRT can be used for short term relief of menopausal symptoms when
this is weighed against the potential harms for individual women.
In December 2003, the NHMRC tendered for the development of a decision aid (DA) to
assist Australian women and their doctors to weigh up the harms and benefits of HRT. The
decision tool is one of three documents to replace previous NHMRC information on HRT.
Its structure and format is based on the Ottawa Decision Support Framework1 and
the NHMRC guidelines for presenting evidence to consumers2 3. The format is a
paper-based booklet and personalized worksheet. It aims to be consistent with the
Cochrane systematic review definition 1 that ‘decision aids provide (at a minimum)
information on the alternatives, benefits and risks that is appropriate for the
patients’ clinical condition.’
They may also include information on:
 the disease or condition;
 tailoring the probabilities of outcomes to the patient’s clinical risk;
 an exercise for clarifying personal values;
 information on others’ opinions or recommendations;
 and guidance or coaching in the steps of decision making and communicating with
practitioners.
Members of this project team have been closely involved in an international collaboration
that has recently developed the International Patient Decision Aid Standards (IPDAS)
http://decisionaid.ohri.ca/IPDAS/. The decision aid has been designed to be consistent with
these standards.
1
O'Connor AM, Tugwell P, Wells GA, Elmslie T, Jolly E, Hollingworth G, McPherson R, Bunn H, Graham I, Drake L. A decision
aid for women considering hormone therapy after menopause: Decision support framework and evaluation. Patient Education
and Counseling 1998;33(3):267-2
2
Barratt Alexandra, Ragg Mark, Cockburn Jill, Irwig Les, Swinburne Lyn, Chapman Simon, 1999 literature review of the
evidence about how to prepare and present evidence-based information for consumers of health services, National Health and
Medical Research Council, Commonwealth of Australia, 2000.
3
O’Connor A, Jacobsen MJ. Workbook on developing and evaluating patient decision aids.
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In March 2004, the Sydney Health Decision Group commenced the development of the
decision aid and completed a first draft by May 2004. A technical report on the development
process is contained as an appendix in the decision aid document and will not be expanded
upon in this report. Expert review was obtained from the members of the NHMRC HRT
Working Committee, two senior epidemiologists and an international expert on decision aids.
The following report documents the process and results of clinician and consumer focus
testing of the decision tool as required by the NHMRC contract. This represents a
preliminary qualitative assessment of the decision aid among practitioners and Australian
women. For a thorough evaluation of the decision aid we would recommend a randomised
controlled trial of the HRT DA is carried out.
2. Focus testing with clinicians and consumers
Objective
To carry out focus testing of the HRT DA among:
a) Consumers from a range of socioeconomic and ethnic backgrounds.
b) Practitioners with a range of clinical backgrounds working with menopausal
women.
The aim of the focus testing was [to] refine the DA and to determine its acceptability among
consumers and practitioners. Among consumers we sought to examine comprehension of the
decision aid and to obtain attitudes and perceptions about its content and design. In addition
we specifically sought to obtain preferences for the worksheet design and presentation of
numerical information on the risks and benefits of HRT. Among practitioners we sought to
obtain responses to the DA content and attitudes to its use.
Design
The focus testing was made up of three sub studies, the results of each are presented below:

Study 1: Convenience testing of the first decision aid draft (n=12)

Study 2: Focus groups with women aged 45-60 years from varying
socioeconomic and ethic backgrounds (n=51).

Study 3: Individual interviews with practitioners working with women
experiencing menopause (n=8)
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Sydney Health Decision Group: HRT Decision Aid
STUDY 1
Study 1: Convenience testing of DA first draft
The decision aid and a brief postal questionnaire (see Appendix 1.1) was sent to 12 women
aged between 40 and 60 years from a range of educational and ethnic backgrounds (see Table
1) to determine their response to the first draft of the decision aid. Women were identified
through colleagues and personal contacts as a convenience sample. All women returned the
questionnaires. The questionnaire was designed to assess whether the decision aid was clear,
easily understood, balanced and covered areas relevant to women’s concerns about
menopause. The results of the questionnaire survey are presented in Table 2. Follow-up
telephone calls were made to obtain further information about the decision aid and to identify
important areas to address for the next draft.
Results
Table 1 Background characteristics
Variable
Age
40-50
51-60
n
%
5
7
42
58
Education
School education
Post school education
Post graduate degree
6
5
1
50
42
8
Ethnicity
Anglo Australian
Indigenous Australian
Chinese
Italian
Greek
Arabic
4
2
2
1
1
2
33
17
17
8
8
17
Current HRT use
Using HRT at present
Used HRT in the past
Never used HRT
1
3
8
8
25
67
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Sydney Health Decision Group: HRT Decision Aid
Table 2. Results of first draft survey
Variable
n
%
Decision Preference
To make it myself with the Dr’s opinion
To share the decision
3
9
25
75
Amount of information provided in the DA
Much less than needed to make a decision
Little less than needed
About the right amount of information
A little more information than needed
A lot more information than was needed
1
0
10
0
1
8
84
8
Length of the DA
Much too long
A little too long
Just about right
Should have been a bit longer
Should have been much longer
0
1
10
1
0
8
82
8
-
How clear was the information in the DA
Everything was clear
Most things were clear
Some things were clear
Many things were unclear
5
6
1
0
42
50
8
-
How balanced and fair did you find the DA
Clearly slanted to taking HRT
A little slanted to taking HRT
Completely balanced
A little slanted against taking HRT
Clearly slanted against taking HRT
Missing
1
3
3
1
1
3
8
25
25
8
8
25
How helpful do you think this DA will be in helping women make
decisions about HRT?
Very helpful
Somewhat helpful
A little helpful
11
1
-
92
8
Would you recommend this DA other women considering HRT?
I would definitely recommend it
I would probably recommend it
I would not recommend it
I would probably recommend it
I would definitely not recommend it
11
1
0
0
0
92
8
-
The results suggested that the length of the first draft and amount of information presented
was acceptable, the booklet was helpful and would be recommended to family and friends.
However, some of the content was seen as unclear and as a result follow-up telephone
interviews were carried out to determine which elements of the decision aid were unclear
among the women we had surveyed. The weigh-scale was identified as the key area which
caused confusion. This was substantially revised in the next version of the decision aid.
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Sydney Health Decision Group: HRT Decision Aid
Outcomes of Study 1
Changes made to the decision aid as a result of Study 1 included:

Simplification of weigh-scales within worksheet

Further simplification of language to the recommended reading level. A Flesch
score of 60% is the recommended level.
The Flesch reading score is a method
of calculating the reading level of a written document. A readability score bases
its rating on the average number of syllables per word and words per sentence.
The reading level of the amended DA was measured as 59.7.

Greater diversity of pictures and photos included (particularly cover photo ie
NOT to use autumn leaves)
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Sydney Health Decision Group: HRT Decision Aid
STUDY 2
Study 2: Focus group study: responses to the decision aid
Design
Women aged between 40-65 years were purposively selected according to their
socioeconomic and ethnic background to participate in group discussions. We had extreme
difficulty organising a focus group with Chinese women and were unable to do so within the
timeframe of the tender. As such no focus groups were conducted with Chinese women. This
difficulty was due to the lack of a translated version of the DA for focus group participants
and cultural barriers to accessing women’s groups and discussing issues around menopause in
a group setting. Both qualitative and quantitative methods were used to examine women’s
responses to the HRT decision aid. Focus group discussions were used to explore women’s
attitudes and preferences towards the booklet using a participant centred and grounded
approach. In addition, a brief anonymous questionnaire was given to participants covering
key aspects of the decision aid in terms of its clarity and comprehension (see Appendix 1.1).
Participants were asked to return the questionnaire in a blank envelope to ensure their
anonymity was preserved.
Participants
Women were recruited through general practices; community pharmacies, local community
centres and community organisations to participate in focus group discussions. A total of 10
groups were conducted with a total of 51 women participants. Women were selected
according to their socioeconomic status and ethnic group (see Table 3). The focus groups
were advertised using flyers and posters in general practices, women’s health centres,
pharmacies and community centres and clubs. Women who were interested in participating
opted into the study by contacting the research team. According to the 2001 Australian
Census, 80% of Australians speak only English at home and the three most common
languages spoken other than English are Chinese, Italian and Greek. As such we chose to
recruit women from Anglo Australian, Chinese, Italian and Greek backgrounds. We also
chose to include Arabic women and Indigenous women in the study since there is evidence
that their perspectives and experiences may be markedly different to the Anglo Australian
population. Women with a range of experience with menopause were recruited into the study.
Data collection and analysis
The focus group was designed to explore preferences for the style, content and format of the
booklet and its clarity and to provide personal information about the experience of
menopause and the decision to take or not take HRT. A copy of the topic guide used for the
focus groups can be found in Appendix 1.2. Groups varied in size from 2 to 8 participants.
Group interviews were audio-taped and transcribed verbatim. Focus groups were carried out
by members of the HRT DA design team (ML and KM) and a researcher recruited solely to
run the focus groups with no involvement in the development of the DA (JC). A thematic
analysis was carried out on the data. The data were categorised firstly according to the
content areas (themes) the data related to in the DA (for example, language, design, weigh
scale, appendices etc) and then secondly, according to whether the comments were positive
or negative. The coding framework was developed and discussed by the researchers (KM, JC
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Sydney Health Decision Group: HRT Decision Aid
and ML) and then subsequently revised for the main coding and analysis. The main analysis
was carried out jointly by KM and JC.
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Results
Table 3. Participant characteristics
Variable
Age
40-44
45-49
50-54
55-60
60-65
missing
N
%
3
12
15
15
5
1
5.9
23.5
29.4
29.4
9.8
2.0
Education
Did not complete school education
School education
Post school education
Post graduate degree
Missing
3
27
16
3
1
5.9
52.9
31.4
5.9
2.0
Ethnicity
Anglo Australia / NZ
Indigenous Australian
Italian
Greek
Middle Eastern
Other Western European (incl British, Scottish, German, Finish)
Other
Chinese (no focus groups carried out in this group)
16
6
9
3
4
12
1
0
31.4
11.8
17.7
5.9
7.8
23.5
1.9
0
Current HRT use
Using HRT at present
Used HRT in the past
Never used HRT
Missing
10
13
26
2
19.6†
25.5
51.0
4.00
† MacLennan et al4 estimate that HRT use in October 2003 was 18.8% in of women over 50
participating in the 2003 South Australian Omnibus Health Survey.
Focus group findings
Overall response to the Decision Aid
Overall responses to the decision aid were extremely positive. Women liked having access to
the information about HRT, which they felt was not available elsewhere. They thought that
the decision aid was a reasonable length for women who are considering HRT or currently
using HRT. They reported that it was well designed, clear and easy to understand.
“The book is attractive, it’s well set out. The use of graphs and so on make it very easy to use and read
and absorb the information and certainly there is a balanced approach to the benefits and the pros and
cons of HRT. Even the use of symbols and what you consider as being a good scientific study as being
a lesser well designed study, all of that is really exceptionally well done so I think you know.. whoever
does that has to be congratulated. But I do think that there is still a bias towards the promotion of HRT
within it”.
MacLenna AH, Taylor AW, Wilson DH. Hormone use after the Women’s Health Initiative Climacteric 2004
7(2):117-9
4
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However, there were also some elements of the decision aid which it was felt could be
improved upon such as the diagrams and information about alternatives to HRT. These are
discussed in detail further below.
“More information on alternatives, I would like to see in the book, even if the book is designed to put a
balance on HRT hormone replacement therapy in that pharmaceutical HRT I guess I still would like it
to perhaps take a broader perspective so that women are right from the word go in the booklet, feeling
that they’re going to be given all of the options, whereas this really isn’t – is a focus on HRT”.
Attitudes to the style and format of the booklet
The style of the DA was well received. The order of the information presented was viewed
as logical and clear. The font size was seen by almost all women as appropriate (not too
small or too large), women also commented that they found the summary table of key points
which describes all the benefits and harms of HRT on one page (p24-25), particularly useful.
“I think if the language is simple enough and this is quite simple, the language, I don’t think it’s overly
technical or there’s not a lot of medical terminology in there and I think most people would understand
that with any kind of basic education and even people from different cultural backgrounds”
In some of the graphics and tables, where the font size was reduced, it was viewed by some
women as too small and required reading glasses. In addition the gold and silver ribbon
graphics were viewed as too small (DA p11) and it was thought that brighter colours and
larger graphics would help them stand out. Comments were also made on the pictures of
women included in the DA and it was viewed that pictures were needed of women from a
diverse range of ethnic and social backgrounds and depicting more variation in emotional
states.
Specific comments were made by some women about the front over, suggesting a more direct
and engaging title such as, ‘should I start some form of HRT’? Some women suggested a
preference for women in menopause age group on the front cover and felt the flower was
meaningless or represented older women and felt they did not want this association.
“if the flower’s not significant then it shouldn’t have centre stage… You know? It doesn’t mean
anything if it were something that had some meaning it would be different but it doesn’t”
Background information about HRT
The introductory section and background information was viewed as clear. The description
of symptoms was described as comprehensive. Information about the different levels of
evidence (gold and silver ribbons) was well received. It was easily understood and well liked,
and was correctly used by most women to weight the evidence presented.
“And I like that gold ribbon and the silver ribbon. There’s – it’s been accepted confirmed so I think
that’s a really good idea”.
A few women felt that the evidence quality information was not needed and felt that only
studies of good quality should be included in the DA.
Whilst some wanted to reduce the background information others suggested increasing the
information.
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“I would have liked a little bit more background information. I mean I know that the book might
extend”
Some women indicated that they wanted more information on symptoms and also on the
social aspects of HRT.
“HRT gives confidence, energy, for jobs and lovers and families”
Attitudes to information about the benefits of HRT
Information about the benefits of HRT was viewed as clear and easy to understand. Some
women were shocked by the information on p12 describing the effect of placebo on
menopausal symptoms. Some women found this information a little difficult to comprehend,
however, most women appeared to understand it after some further thought. Some felt the
information was not necessary whilst to others the information seemed to convey well the
perceived effect of HRT compared to the real effect of taking HRT on menopause symptoms.
The 1000 dot diagrams were well understood and there were preferences for different styles
of presentation expressed (see appendix 5 below). The use of both numbers in coloured
highlighted text and diagrams was particularly liked. The use of red was questioned and it
was suggested that this colour indicates danger. The complications of using red and green and
colour blindness were raised. There was a preference for the use of other bright colours.
Description of what the diagrams meant (in italics) was also found to aid comprehension.
Some women seemed to understand that the diagrams represented the risk accrued among
1000 women following 5 years but this point did not seem to be grasped by all women, so
needed further emphasis.
“I like visuals. I prefer to have something there with the numbers there as well. I like those.”
“I figured it out yes. It’s good and it makes it stand out so there is a difference, you can see – actually see
the difference.”
“I found dots hard to approach! Perhaps it’s nothing visual I just didn’t’ take the information in and I
had to go back and go back before I got the information because I’m not used to a graph in this way
just in this new form so it was hard for me to absorb the information but that’s just me”
Attitudes to information about the risks of HRT
Many women were surprised by the number of risks associated with HRT. Women varied in
their response to the figures presented. Some women viewed the risks as small and of
comparatively little significance whilst others viewed any increase in risk as important and
potentially avoidable. In this case the risks presented were perceived as high. However,
there was no evidence that women felt anxious because pf reading the information about the
risks presented in the DA. There was good comprehension of the information that describes
research that showed no effect on certain outcomes and where the outcome of studies was
unclear (p22)
“I was looking in the book and I was quite surprised that the difference in not taking it and taking it
there’s only 4 women in 1000 – that’s a very low percentage. No one wants to be a statistic but you
know”.
Some women wanted information on combined risks such as family risk, taking the pill then
HRT, also wanted more information about what happens beyond the 5 years follow up.
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Preferences for the presentation of numerical information
A variety of formats of the numerical information was shown to participants on laminated
cards (see appendix 5) to determine the preferred format for the presentation of risk
information out of 1000. Almost all women liked the use of the 1000 dot diagrams and found
that this combined with text aided their comprehension of the risks and benefits. There was
variation in preferences but almost all women preferred the diagrams with the dots
highlighted as coloured blocks (see below) as they found the pattern of many dark dots on
white background disturbing. Women varied in their preference for horizontal or vertical
presentations on quantity, but on balance more women preferred the horizontal presentation.
However, coloured dots were preferred to be placed either in the bottom right or top left (see
below). Some women preferred all the risks and benefits presented on one diagram (see
below). This was seen as more concise and allowed easy comparison. Others preferred the
risks and benefits presented separately on different diagrams.
15
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Of 1000 women in their 50’s who DO NOT take HRT,
over five years:
3 women may get bowel cancer
1 woman may have a hip fracture
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Responses to the Health Profile and Worksheet (p26-32)
Steps in making the decision and the reasons for considering HRT were well received (p2627). These sections were seen as clear and easy to understand. The section ‘My Personal
Health Profile’ appeared difficult for many women to follow correctly. Most women
appeared to read it but not fill it in or understand that it was intended that they identify their
own personal risk factors and then incorporate this into their decision. Revision of this
section is needed. Two examples of the weigh scale were examined in the focus groups (see
weighscale A and weighscale B). In one version (A) the weigh scale was filled out (see
below). In the other version, the weigh scale was left blank for respondents to complete (as
below). Among participants, there was consistent preference for the completed worksheet.
Women felt that it was too much work to go back through the booklet to remember and
summarise for themselves the reasons; they liked to be reminded in the completed version of
the worksheet. The final section, p 32 which gives women space to write down any questions
for their practitioner was well liked and viewed as valuable to help women remember their
questions during consultations with their GP.
“And the other point you made was good too where this is actually an invaluable page for a lot of
people because look how many times we go to the doctor thinking ‘I must ask him about those things’
‘I thought, Hmmmm I don’t like [this] and I don’t like that, and I was always thinking about it anyway,
but it does help you make those decisions and that’s what I think. It’s just nice to have something to go
well here’s all that and there’s all that. Now where do I sit with this?’
‘If you’ve got a book like this then you can say well hang [on] a minute, could you please expand this
point and if you don’t know could you please find out for me, or you’re aware of this point, could you
please find it out? It’s something that you can have there as a tool. Say ‘Look, it’s there, could you
please go further for me?’
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Weighscale A
Step 3a: Weighing up the pros and cons
Now fill in the weigh scale below to help you work out which way you are leaning in your decision.
What is important to me?
Please show how important the reasons for and against HRT are to you by shading the circles beside
the reasons. More shading shows more importance
E.g. Extremely important to you:
Not at all important
О O О O О O О Extremely Important
E.g. Not important to you:
Not at all important
О O О O О O О Extremely Important
Reasons to start HRT
Relief from menopause symptoms (hot
flushes, night sweats, sleep disturbance,
irregular periods)
Not at all
Important
О O О O О O О Extremely
Important
Relief from other menopause symptoms
important to you___________________
Not at all
Important
О O О O О O О Extremely
Important
Reducing my risk of colorectal cancer
Not at all
Important
О O О O О O О Extremely
Important
Reducing my risk of bone fracture
Not at all
Important
О O О O О O О Extremely
Important
Other reasons for taking HRT important to
you _______________________________
Not at all
Important
О O О O О O О Extremely
Important
Reasons not to take HRT
Increasing my risk of Breast cancer
Not at all О
Important
O О O О O О Extremely
Important
Increasing my risk of heart attack and/ or
stroke
Not at all О
Important
O О O О O О Extremely
Important
Increasing my risk of blood clots
Not at all
Important
О O О O О O О Extremely
Important
Increasing my risk of nuisance symptoms
(breast tenderness, spotting/ periods
returning)
Not at all
Important
О O О O О O О Extremely
Important
Other reasons for NOT taking HRT
important to you ____________________
Not at all
Important
О O О O О O О Extremely
Important
Which way are you leaning in your decision?
Fill in one of the squares below to indicate which way you are leaning in your
decision.
HRT
Not sure
No HRT
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Weighscale B
Step 3b: Weighing up the pros and cons
Now fill in the weigh scale below to help you work out which way you are leaning in your decision.
What is important to me?
Write in the boxes below reasons for and against taking HRT that you feel are relevant to you. Show
how important each reason is for you by shading the circles. More shading shows more importance
E.g. Extremely important to you:
Not at all important
О O О O О O О Extremely Important
E.g. Not important to you:
Not at all important
О O О O О O О Extremely Important
Reasons to start HRT
Reasons not to take HRT
____________________________
____________________________
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
____________________________
____________________________
Not at all
Important
О O О O О O О Extremely
Important
Which way are you leaning in your decision?
Fill in one of the squares below to indicate which way you are leaning in your
decision.
HRT
Not sure
No HRT
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Responses to the appendix and the provision of additional information
(including alternative therapies)
There was considerable interest in the information contained in the appendix (DA page 3436) about alternatives to HRT, including alternative therapies and other medication. Many
women felt that this information should be presented earlier on in the booklet and that its
location at the back suggested it had been relegated to the back pages and was considered as
less important. However, other women were satisfied with its position in the appendix but
asked that it be referred to more clearly in the main section of the booklet. Many women
wanted more detailed information about each of the items included in this section, but
recognised the need to keep the booklet short. There was particular concern about the
references to the use of Efexor (an antidepressant) for hot flushes. Women were confused by
this and more explanation is required, many seemed to confuse this with the need for the
relief of psychological symptoms. Women also commented that the lay out in this section of
the booklet could be improved. Importantly, women indicated that referring women to
websites, although helpful for some women, may be less helpful for many women who had
little access to the internet or had to rely on family members to do it for them. It was widely
recognised that in personal health issues such as HRT it was difficult to ask for family help.
A strong preference was expressed for women to be referred to accessible books which
provided further information in a clear and simple way.
“Very good. I read it too. Love the, ‘what you can take like instead of taking HRT’ other like
medication that you can take. Less risk”.
“There are alternatives but I’d like to see that expanded”
Cultural issues
The focus testing of the DA included women from diverse social and ethnic background
including, Italian, Greek, Lebanese, Western European and Indigenous Australian
backgrounds. The DA was found to be culturally acceptable to all the women focus tested.
Important points identified by women from these groups was a) the need to include pictures
of women from diverse ethnic backgrounds in the booklet and b) the importance of
translating materials into different languages for women from NESBs. We found the latter to
be particularly important for Chinese women of this age group. The lack of translated
materials into Chinese was a major factor in preventing us from carrying out focus groups
with women from the Chinese community. As such further examination of Asian women’s
attitudes to HRT information with translated materials is needed.
Across all groups there was considerable interest in the issues around menopause. The
booklet was well accepted and the format in which the information was provided was well
received. Preferences for the presentation of risk information were similar across all the
groups. The importance of providing book references in addition to web sites was
highlighted by women who said they had little access to the internet. Women across all
social and ethnic groups were particularly interested in alternatives to HRT, and wanted more
information about how to stop HRT.
Among Indigenous women the need to include pictures of Indigenous women throughout the
booklet was raised as a particularly important issue and was seen as crucial for the booklet to
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be viewed as credible to an indigenous audience. The importance of including women from
different ethnic and socioeconomic backgrounds was also highlighted, and it was suggested
these images of women may be used on the front cover of the booklet to immediately attract
readers from diverse backgrounds.
“We’d like a picture of a group of women on the front, multiethnic group from different backgrounds
and an aboriginal woman”
Indigenous women also highlighted the importance of providing a telephone contact number
and a postal address to find out more information, rather than referring readers to websites,
which were viewed as inaccessible to most Indigenous women of this age group. Information
about how to contact local menopause support groups was also suggested as valuable.
Women wanted more explanation of the reference system which was not understood and the
origin of the research rating system. Similar to all other groups, there was a preference for
the graphs to be presented in brighter, clearer colours.
“We couldn’t find one telephone number in the book. Aboriginal women need a phone number, they
can’t get to a web address, they don’t know how to use it”
“The dots in these colours are difficult to see. They make my eyes go funny”
Further information requested and suggestions for improving the DA
More information about the following aspects of HRT use or ways of presenting the current
information was suggested:
1. Strong desire for more information about how to come off HRT and what the
symptoms are likely to be and how long they will last:
2. Strong desire for information to be translated into different languages for women from
culturally and linguistically diverse backgrounds.
3. To explain graphs more clearly by highlighting the length of time HRT was taken by
women in the data presented in the graphs and the 5 year follow-up period,
4. To highlight both the ‘number’ and ‘out of 1000’ in text in colour and bold in the text
accompanying the graphs.
5. To provide information about where women can obtain the references cited in the
bibliography. One suggestion was to make them available on a website.
6. To include a description of how HRT works in background information
7. To state clearly that the DA is independent of pharmaceutical companies
8. To add more information on the social aspects of HRT use
9. To put HRT in bright letters on the front cover so readers immediately know what it is
about.
10. To add a telephone number for further information and explain how to contact local
support groups
Questionnaire survey of focus group participants
All focus group participants completed a questionnaire on their attitudes to the DA. The
results are presented in the table below.
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Table 4. Questionnaire survey of attitudes to Decision Aid
Variable
N (%)
How do you prefer to make decisions about your healthcare
I prefer to decide myself after listening to the opinion of my Dr
I prefer to share making the decision with the Dr
I prefer my Dr to decide for me
Missing*
25 (49.0)
23 (45.1)
0 (0)
3 (5.9)
Amount of information provided in the DA
Much less than needed to make a decision
Little less than needed
About the right amount of information
A little more information than needed
A lot more information than was needed
Missing
3 (5.9)
8 (15.7)
26 (51.0)
4 (7.8)
3 (5.9)
7 (13.8)
Length of the DA
Much too long
A little too long
Just about right
Should have been a bit longer
Should have been much longer
Missing
1 (2.0)
3 (5.9)
32 (62.7)
7 (13.7)
1 (2.0)
7 (13.8)
How clear was the information in the DA
Everything was clear
Most things were clear
Some things were clear
Many things were unclear
Missing
16 (31.4)
18 (35.3)
7 (13.7)
2 (3.9)
8 (15.7)
How balanced and fair did you find the DA
Clearly slanted to taking HRT
A little slanted to taking HRT
Completely balanced
A little slanted against taking HRT
Clearly slanted against taking HRT
Missing
1 (2.0)
7 (13.7)
28 (54.9)
7 (13.7)
1 (2.0)
7 (13.8)
How helpful do you think this DA will be in helping women make
decisions about HRT?
Very helpful
Somewhat helpful
A little helpful
Missing
24 (47.1)
16 (31.4)
4 (7.8)
7 (13.8)
Would you recommend this DA to other women considering HRT?
I would definitely recommend it
I would probably recommend it
I would probably not recommend it
I would definitely not recommend it
Missing
22 (43.1)
19 (37.3)
3 (5.9)
0 (0)
7 (13.8)
* some women from non english speaking backgrounds had difficulty completing the questionnaire fully. This
accounts for the missing data on questionnaire items.
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Outcomes of Study 2
A more detailed description of focus group comments and the project team’s responses is
located in Appendix 2 of this report. A summary of changes undertaken is provided below:
Clarification of wording across many sections of the decision aid

Block configuration adopted for graphs

Section added to worksheet for doctor’s notes to encourage shared decisionmaking

Steps in decision making simplified substantially and more closely linked to the
weigh-scales activity. Duplication in these sections removed.

New section added – when to stop HRT

Reformatting and clarification of HRT alternatives appendix

Information added about how to access the original papers

Reference system explained

Explanation of origin of research rating system given

Technical appendix included
23
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STUDY 3
Study 3. Telephone interviews with clinicians
Sample: Practitioners from a range of backgrounds with experience working with
menopausal women were sampled for telephone interviews. Participants were recruited
through advertisements placed in newsletters and sent to relevant professional organisations
and through personal letters sent to listed specialist practitioners in North and Central
Sydney. The following practitioner groups were identified for inclusion for interview: general
practitioners, gynaecologists, menopause specialists, family planning / women’s health
doctors and nurses.
Design: Telephone interviews were carried out with practitioners. Practitioners were sent the
DA to review in advance and were telephoned to take part in an interview to determine their
response to the DA. A copy of the clinician interview topics can be found in Appendix 3 of
this report. Interviews were carried out by ML and JC. Interviews were audio-taped and
transcribed verbatim for analysis. Interviews were coded using the coding system described
in Study 2 and thematic analysis was carried out on the data (see page10-11).
Results
A summary of the clinician characteristics is contained in Table 5 below
Table 5. Practitioner characteristics
Gender
Female
Practitioners
Male
Practitioners
No
Classification
Organisaton
Rural/Urban
Location
1
FPA RN
Rural
Southern NSW
1
FPA RN
Urban
Inner Sydney
1
2
FPA GP
GP
Family Planning Association
– Women Centres
Family Planning Association
– Women Centres
Community Centre
Aboriginal Services
Urban
Urban
South Eastern Sydney
Inner Sydney
1
GP
Private Practice
Urban
North West Sydney
1
Menopause
Specialist
O+G specialist
Private Hospital
Urban
North Sydney
Medical Centre
Urban
Inner Sydney
1
HRT decisions, role of Decision Aids and clinician’s preferences for decision making
The complexity of the new WHI information was acknowledged as women and their
practitioners need to weigh up the benefits and harms of HRT. The decision aid’s capacity for
involving women in HRT decision-making appeared to be well recognised and valued by
those interviewed.
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‘It’s good. The whole idea is that you’re involving the patient in making the decision which is always a
good idea’
(Male GP)
Reactions to HRT decision aid
Generally, the clinicians were very positive about the decision aid and would recommend it
to their colleagues and patients.
‘Fantastic, educates [in the] process of decision making for starting and stopping [HRT]’
(Male O&G)
‘I teach a lot of doctors about menopause… I could use this as a teaching aid’
(Female FPA MP)
‘I think there’s a place for them and it would mostly be me giving them [the women] something to take
away and come back’
(Female FPA MP)
The representation of the probabilistic information was well received and thought to be very
useful, particularly for communicating levels of risk in absolute terms.
‘I thought those diagrams were absolutely superb. You know the dots?....That was very explanatory.
That put it into perspective’
(Male O&G)
There were mixed opinions about the length of the decision aid and the amount of
information. Some felt that the amount of information was about right and others felt that it
was too complex and lengthy. There were also a few concerns about the level of literacy
required and the tool’s acceptability for women from non-English speaking backgrounds. It is
interesting to note that the clinicians felt that the decision aid was slightly biased toward the
harms of HRT whereas the majority of consumers felt that the decision aid was balanced and
fair (60%), and 17% felt it was slightly biased toward the benefits of HRT. Only 14% felt it
was biased towards the harms of HRT as the clinicians had suggested. It was also noted that some
practitioners felt that women would not be interested in the information about alternatives to
HRT. However, this came across strongly among all women as an important section of the
DA and an area they wanted more information.
Using the Decision Aid in your clinical practice
Many of the clinicians believed that one of the most potentially practical aspects of the
decision aid was its ability to allow women to consider the information outside the
consultation. In addition to saving time within the consultation, clinicians felt that the
information was of a very high quality and appreciated that the evidence had been appraised
and summarised by experts. Not only was the information summary valuable to their patients
but many of them felt that it was useful for them too. It was suggested that clinicians should
be provided with a space to write comments or managements plans within the worksheet.
‘[It should] make [my] job faster and easier. [I appreciate] the time spent by others who understand the
issue……Excellent…… helped me too!’
(Male GP)
‘I think whoever’s done this has carefully assessed with quality of evidence and I think it’s quite good
really’
(Male O&G)
‘[The decision aid] allows them [the women] to go through the process of making the decision about
what reasons are important to them for starting and stopping treatment’
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(Female indigenous + GP)
Outcomes of Study 3
A more detailed summary of the practitioner comments and the project team’s responses is
found in Appendix 4 of this report. Summary of changes undertaken:
Clarification and formatting as appropriate

New section added to worksheet for clinician comment and summary
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Recommendations to NHMRC for the final design and publication of the Decision Aid
The following section lists the recommendations made by study participants for the design
and format of the final version of the decision aid by the NHMRC in-house design team.
1. Include pictures of women from different multiethnic, indigenous and socio-economic
backgrounds throughout the booklet.
2. Include contact details of NHMRC approved organisations with telephone numbers
and addresses for further information, and refer readers to books in addition to
websites.
3. To put ‘Hormone Replacement Therapy’ in bright letters on the front cover so readers
immediately know what the DA is about.
4. To use a picture of women of the appropriate age range from multiethnic and
socioeconomic backgrounds, on the front cover of the DA.
5. To increase the size and brightness of the gold and silver ribbons used to describe
research quality.
6. To translate the booklet into different languages for NESB women.
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APPENDICES
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APPENDIX 1
1.1 Questionnaire used in Study 1 and Study 2
Feedback on the HRT booklet you have just read.
How would you rate the amount of information in the booklet? (please tick one box only)
Much less than needed to make a decision
Little less than needed
About the right amount of information
A little more information than needed
A lot more information than was needed





How would you rate the length of the booklet?
Much too long
A little too long
Just about right
Should have been a bit longer
Should have been much longer





How clear was the information in the booklet?
Everything was clear
Most things were clear
Some things were clear
Many things were unclear




How balanced and fair did you find the booklet?
Clearly slanted towards starting HRT
A little slanted towards starting HRT
Completely balanced
A little slanted against starting HRT
Clearly slanted against starting HRT





How helpful do you think this booklet will be in helping women make decisions about HRT?
Very helpful
Somewhat helpful
A little helpful
Not helpful




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Would you recommend this booklet to other friends considering HRT?
I would definitely recommend it
I would probably recommend it
I would probably not recommend it
I would definitely not recommend it




WE WOULD LIKE TO FIND OUT A LITTLE ABOUT YOU
1. How old are you? _____________ years
2. Were you born in Australia? Y / N
If no, which country were you born in? _________________
3. Do you speak a language other than English at home? Y / N
If yes, which language do you speak? __________________
4. What is the highest level of education you have completed?



Completed school education
Completed post school education such as a degree or diploma
Completed postgraduate degree(s)
5. Tick the box that best describes your HRT use:



I currently use HRT
I have used HRT in the past, but am not taking it now
I have never used HRT
6. Are you currently considering whether to use HRT?


Yes, this choice is relevant for me now (pls go to question 7)
No, this choice is not relevant for me now (pls skip to question 9)
7. At the moment, how far along are you with your decision about using HRT?




I have not yet thought about the options
I am considering the options
I am close to choosing one option
I have already made a choice
8. How you feel at the moment about using HRT? I am leaning towards

Using HRT
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

Not using HRT
Unsure
9. Tick the box that best describes how you prefer to make decisions about your health care:



I prefer to decide myself after listening to the opinion of my doctor
I prefer to share making the decision with my doctor
I prefer my doctor to decide for me
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1.2 Consumer focus group topic guide
HRT Decision Aid
Consumer focus group topic guide
1. Introduction

Introduce self

Discuss purpose of the focus group and aim of the decision aid

Reminder about confidentiality of opinions and responses

Confirm consent to record interview

Ice breaker
2. Sections of the decision aid
a. Introductory information
i. What do you think the purpose of the decision aid is?
ii. Who do you think the DA is aimed at ?
iii. Do you think that this is clear and obvious?
How could it be made clearer?
iv. Would you include any additional information?
If Yes What would you include?
Why would you include it? (prompt – How would you
use this information?)
If No – go to b.
b. Background HRT and menopause information
Thinking about the background information about HRT and the menopause on
pages 1-10.
i. How clearly was it presented?
ii. How could it be made clearer?
iii. Would you include any additional information? If yes what and why?
iv. Should any of the information be removed?
If Yes –
What information?
Why would you take it out?
If No –
Go to c
c. Benefits of HRT
Thinking about the information presented about the benefits of HRT on pages 1115 and 24.
i. How clearly was it presented?
ii. How could it be made clearer?
iii. Would you include any additional information? If yes what and why?
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iv. Should any of the information be removed?
If Yes –
What information?
Why would you take it out?
If No –
Go to v
v. Did you look at the diagrams of the 1000 women dots?
a. What did you think was the point of the dots?
b. Did they make it easier or harder to understand the
information?
i. Why do you think it made it easier/harder?
c. How did you feel seeing this information as 1000 dots
rather than text?
i. Which do you prefer?
ii. Why do you prefer the information presented
this way?
d. Did you prefer the diagrams with the dots horizontal or
vertical? Why?
e. Which way (horizontal or vertical) do you find is easier
to understand? Why?
f. How could these diagrams be improved? (prompt –
What changes would you make?)
d. Harms of HRT
Thinking about the information presented about the harms of HRT on pages 1725.
i.
ii.
iii.
iv.
How clearly was it presented?
How could it be made clearer?
Would you include any additional information? If yes what and why?
Should any of the information be removed?
If Yes –
What information?
Why would you take it out?
If No –
Go to v
v. Did you look at the diagrams of the 1000 women dots?
a. What did you think was the point of the dots?
b. Did they make it easier or harder to understand the
information?
i. Why do you think it made it easier/harder?
c. How did you feel seeing this information as 1000 dots
rather than text?
i. Which do you prefer?
ii. Why do you prefer the information presented
this way?
e. Worksheet (values clarification exercise and weigh scale)
i. Did you complete the worksheet ?
1. Yes – go to ii.
2. No – why didn’t you complete the worksheet? Go to Q3a.
ii. Were the instructions easy to understand?
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Sydney Health Decision Group: HRT Decision Aid
iii.
iv.
v.
vi.
vii.
viii.
1. Could they be improved?
a. Yes – How could they be improved?
b. No
How long did it take you to complete the worksheet?
How did you find layout – easy to read / understand?
We have developed 2 versions of the worksheet. Which do you
prefer? Why?
Which version is easier to understand? Why?
Which version is easier to complete? Why?
Did you read the example worksheets and patient stories?
If Yes – Were they helpful? Why? prompt –Would you make nay
changes to them? What changes would you make? Why?)
If no – why didn’t you use them?
f. Appendix
i. Did you read appendix?
1. Yes –
a. Tell me why you read this information.
b. How did you find this section? (prompt – How useful
was it? How easy was it to understand? What could be
one to make this section easier to understand? Could
any of the information be included in the main part of
the decision aid? Why would you make these changes?)
2. No – tell me why you didn’t read this information.
g. Overall, would you make any changes to the order in which the
information was presented?
i. Yes –
1. What changes would you make?
2. Why would you make these changes?
ii. No
3. I’d now like to ask you some general questions about the decision aid.
a. How long did it take you to read the decision aid, not including
completing the worksheet?

Was the font size appropriate?
i. Yes
ii. No – how would you change it?

What do you think about the colours that were used? (Prompt - Are the
colours used easy to see? Are they appropriate?)

How did you find the length of the DA overall?

How would you rate the amount of information in the decision aid and
worksheet?
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Sydney Health Decision Group: HRT Decision Aid
i. Were there any particular sections where you would have liked more
information?
ii. Were there any particular sections where you would have liked less
information?
iii. Did you have any questions that weren’t answered in the decision aid?
1. Yes – What were these questions?
2. No

Thinking about the decision aid overall, how balanced and fair was the
information?

Describe how you felt when reading this decision aid (probe for emotional
reactions to the information).
i. Which sections in particular made you feel this way? (explore what it
was about these sections that made the person have the response they
did)
ii. Overall, did the information in the decision aid make you feel anxious
at all?

Overall, how well do you feel you understood the information?

Overall, how helpful was the decision aid for women making a decision
about whether to continue of stop having screening mammograms?

If a women did think there was a decision to make, how helpful do you
think she would find the decision aid? (show card 10) which card- should it
be in appendix
What else could we do to help women make a decision about whether or
not to have another screening mammogram?

Would you recommend this decision aid to other women you know who
are considering HRT?
i. Why would you recommend it?
ii. Why wouldn’t you recommend it?
2. Closing

As this is a new area of research, we may have missed something
important in this interview. Thinking now about using the decision aid, is
there anything that comes to mind that we haven’t discussed today?

Thank you for your time today.
36
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Sydney Health Decision Group: HRT Decision Aid
APPENDIX 2
Summary of consumer comments and responses
Background – p1-10
DA Page
Recommended Change
Action
8
State why different types of HRT,
when used + trade {brand} names,
indicate costs{?}
Also, state how HRT works, and the
source of the hormones (e.g.
synthetic or from horse’s urine)
Summarise media reports + add (to
show value of research) + keep
updated
Provide info on less common
symptoms e.g. high blood pressure
Info about Ottawa Health Decision
etc. intimidating {edit?}
NHMRC – give full name
State DA is independent from drug
companies
Need information about when to
come off HRT, which symptoms
likely to return, how do you stop –
wean?, what needs to be
investigated
Make easier to read for people with
poor literacy
Is there relevance to ordering of
HRT types in list? Assume those at
top of list better {list alphabetically,
list by frequency of use?}
HRT information is consistent with
the other NHMRC booklet in this
series
many
many
2
2
many
many
8
Not added due to space
constraints
Hypertension not a menopausal
symptom
Acknowledgements reformatted
As above
New section added on the
evidence for stopping HRT
Reading age falls within
recommended range
Order changed to reflect most
commonly used to least common
Benefits– p11-15
DA Page
Recommended Change
Action
11
Silver ribbon next to Irregular
periods – what does that mean –
will it stop irregular periods? –
{Maybe explain rating system
more?}
Yellow and silver ribbons difficult to
see suggest change colour
Idea of placebo difficult to
understand {explain
further/remove?}
Section on irregular periods
removed following working party
comments
11
12
Not changed
Wording associated with this
section altered to improve clarity
Harms– p17-21
DA Page
Recommended Change
Action
17
Add information on combined
Not within scope of this document
effects of lifetime taking pill + HRT – and limited evidence available
increases risk? {add information?}
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Sydney Health Decision Group: HRT Decision Aid
Graphs– p 12-15
7 18-21
DA Page
Recommended Change
Action
12-13
Idea of graphs representing 5 year
period could be clearer {reword/explain further?} note: not all
women found this confusing
Simplify graphs, too much info and
confusing
Wording associated with graphs
altered to improve clarity
12-13
As above
General preferences for graphs from focus groups
Horizontal preferred (e.g. it imitates reading, our brain interpreting it as words,
doesn’t strobe as much)
Dots at top preferred
Separate graphs for outcomes preferred
Solid version of dots well liked (though would prefer other colours than red/green
used)
Details below:
many
The dots strobe,
use star or asterix for red dots to
make them stand out more
Laminated Red dots at top preferred
Sheet 1
(e.g. Didn’t notice dots at bottom,
(LS1)
put on first line)
LS1
Generally horizontal lines preferred
(e.g. it imitates reading, our brain
interpreting it as words, doesn’t
strobe as much)
LS 2
Combined graph too confusing (not
sure whether to include coloured
dots with black dots)
LS 2
Pink and red dots too similar
LS 2
White dots in the middle don’t make
sense
LS 3
Keep results on separate graphs
LS 3
Keep position of coloured dots
consistent, put at the top
LS 3
Don’t like dots at all, prefer without
graphs
LS 3
Light blue background too light for
white dots
LS4
Background solid easier to see,
preferred
LS4
LS4
Red/ green colour combination not
liked (e.g. colours ugly, opposing
colours cause stress)
[c] & [d] missed the pink dots on
graph, change colour
Block images adopted as per
focus group results
As above
As above
As above
As above
No change required
As above
No change
As above
As above
As above
As above
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RFT 063/0304
LS4
LS4
LS5
LS 5
LS 6
Sydney Health Decision Group: HRT Decision Aid
Don’t like coloured dots on purple
background
Prefer vertical with solid
background and small dots
Dots at beginning preferred
Horizontal dots preferred
Need darker background with block
colour
As above
As above
No change
Not changed
As above
Other possible health effects & Summary p 22-25
DA Page
Recommended Change
Action
22
Need definitions of words i.e.
General Health – don’t understand
concept
Summary is too early, provide after
alternatives to HRT section
Not changed. Kept consistent with
WHI results
24
STEP 1 & STEP 2 – p26-30
DA Page
Recommended Change
29 & 30
29 & 30
Inconsistency - Provided example is
related to breast cancer, then
Reasons to take HRT both appears
next… suggest relocating example
Move my personal health profile
closer to p11 gold and silver
ribbons
Not adopted
Action
Steps to decision making
substantially revised and
simplified.
As above
Worksheet , p31- 32
DA Page
Recommended Change
Action
31
Move worksheet, should go before
summary
29-30 &
31
Split worksheet, p29 & 30 to go
before summary, p31 to go just
before appendix
Not adopted. Needs to stay within
steps to decision making.
Changes made now create better
connection between steps and
worksheet
As above
Need a list of questions to ask Dr
(prompts)
Added new section for doctor’s
notes
Information , p33
DA Page
Recommended Change
Action
33
Need extra links- NSW focusWomen’s health Leichardt centre
NHMRC to add approved
resources
Alternatives to HRT Appendix, p34-36
DA Page
Recommended Change
Action
34-36
Move to p8, otherwise seems like
an after thought
Not adopted.
39
RFT 063/0304
34-36
Sydney Health Decision Group: HRT Decision Aid
Put alternatives section earlier
Rearrange list- medication for
depression should not appear first
34-36
Perhaps subdivide alternatives into
sub sections
34-36
The word alternative has negative
connotations change to
‘complimentary’
34-36
Need more information on
antidepressants
Need explanation of why
antidepressants included, makes
women seem like sad older people
References Appendix, p.37-39
DA Page
Recommended Change
37-39
The appendix on alternatives to
HRT was substantially updated.
The for matting and some of the
content clarified.
As above
The term alternative means ‘toher
options’ and the term
complimentary would not provide
this meaning
This point has been clarified in
the revisions
Action
Provide list of books which are easy
for non medical people to read
37-39
Identify which books on list are
easier to read
37-39
Typo in ref 3 - country
37-39
Need direction to other more
manageable resources
37-39
Indicate source of references –
where can women find them
Graphics/cover layout/ visual issues
NHMRC to provide approved
resources
As above
DA Page
Recommended Change
Action
Front
cover
Desktop publishing to be
completed by NHMRC prior to
public release
Front
cover
Front cover larger font – HRT,
smaller picture
Words HRT in larger font and
‘making decisions’ smaller font
Cover to appeal to multicultural
women
Add something humorous on cover
Provide botanical name for flower,
provide photo credit
Front
cover
Use picture of women in
menopause age group on cover
As above
Front
cover
Photos represent older women, do
not want this image
As above
Photos
Need clearer photos, try cartoons
too
Need positive images for women
As above
Front
cover
Photos
As above
As above
As above
As above
As above
As above
40
RFT 063/0304
Photos
Sydney Health Decision Group: HRT Decision Aid
going through menopause
Multicultural images on photos to
include all women
As above
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Sydney Health Decision Group: HRT Decision Aid
APPENDIX 3
HRT Decision Aid
Clinician interview topic guide
1. Introduction

Introduce self

Discuss purpose of the interview and aim of the decision aid

Reminder about confidentiality of opinions and responses

Confirm consent to record interview
2. Background: HRT decisions, role of Decision Aids and clinician’s
preferences for decision making
 Attitudes to giving women information about HRT
How do you find giving women information about HRT given the changes in
evidence in past few years. Are there any particular difficulties? If yes, what are
they? How do you manage this? Do you feel you would like more support in
giving women information about HRT.
 Role of Decision Aids in clinical practice
Have you had any experience using decision aids with your patients. What do you
think of DAs in general? Why do you think this? In
what way do you see that they can be helpful in your clinical practice, in what
way do you see that they can be unhelpful? Why?
 Preferences for decision making with patients
How do you feel about making clinical decisions with your patients? How do you
feel when patients take an active role? Why? How do you feel when they defer all
decision making to you? Why? What is your preference? Why?
3. Reactions to HRT DA
 What was your reaction to the DA overall? Why?
What do you see as the advantages of using the DA and what are the
disadvantages?

What was your reaction to the background information section of the DA
(pages 1 to 10)?
Prompts: Adequate detail, any information missing, too much information, clarity
of information

What was your reaction to the benefits section of the DA (pages 11 to 15
and 24)?
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Sydney Health Decision Group: HRT Decision Aid
Prompts: Adequate detail, any information missing, too much information, clarity
of information
 What was your reaction to the harms section of the DA (pages 17 to 25)?
Prompts: Adequate detail, any information missing, too much information, clarity
of information

What was your reaction to the worksheet section of the DA (pages 27 to
31)?
Prompts: Adequate detail, any information missing, too much information, clarity
of information

We presented the information in 2 sections of the booklet in different
ways. Can you tell me which you prefer? Why? Which do you think is
easier to understand for people?
i. Horizontal vs vertical dots
ii. Weigh scale

What was your reaction to the Appendix section of the DA (pages 34 to
39)?
Prompts: Adequate detail, any information missing, too much information, clarity
of information

Overall, would you make any changes to the order in which the
information was presented?
If yes, what and why?

How did you find the length of the DA overall?

How would you rate the amount of information in the decision aid and
worksheet?

Overall how clear was the decision aid?

Thinking about the decision aid overall, how balanced and fair was the
information?
4. Using the Decision Aid in your clinical practice

How would you feel about using this decision aid in your own clinical
practice?
 What would be your preferred way to use it in your normal consultation?
How would it affect you normal consultation?

What do you think the barriers would be to using the DA in routine
clinical practice?
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Sydney Health Decision Group: HRT Decision Aid

Overall, how well do you feel your patients would understand this
information?

How useful do you think your patients would find this decision aid? Do
you think they would find it useful?

Would you recommend this decision aid to be used by other clinicians
that you know?
Why would you recommend it? Why wouldn’t you recommend it?
5. Additional comments, views about the DA and its use in clinical practice

As this is a new area of research, we may have missed something
important in this interview. Thinking now about using the decision aid, is
there anything that comes to mind that we haven’t discussed today?

Is there any other information that you feel should be included in the
decision aid?

Is there any information that you feel should be given to practitioners
who will use the decision aid?
6. Closing


Thank participant for their time.
Reiterate the purpose of the interview and confidentiality

Offer to send them the final report if they are interested.
44
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Sydney Health Decision Group: HRT Decision Aid
APPENDIX 4
Summary of clinician comments and responses
Background – p1-10
DA Page
Recommended Change
Action
many
Include tibolone discussion in rest of
book not just background
many
Wording- change HRT to HT
/Hormone Therapy – latest
international acceptable wording
{Change/ leave?}
Discussion of Symptoms – some not
due to menopause e.g.
heavy/irregular periods in premenstrual phase + trt different –
remove/discuss separately
Testosterone use not evidence based,
not approved by TGA {remove?}
No mention of early menopause and
taking HRT
Info needed for women without a
uterus, esp. young women after
hysterectomy & premature ovarian
failure
Add HRT brand names
Not within scope of this
document. Further information
available in information booklet
NHMRC Working Party
instructions not to us HT but
prefer HRT
5
8
3
8
Add information on Alzheimer’s,
dementia & oestrogens only
Sore breasts – use of redgen not
discussed in DA
More information about
symptoms contained within the
information booklet
Removed
Included in background
Not within scope of this
document
Not done. Generic drug names
preferred
Separate DA required for
information about oestrogen
only
Treatment of side effects not
included. Weak evidence base
Benefits– p11-15
DA Page
Recommended Change
Action
many
Needs information on oestrogen alone
– graphics
Could reduce amount of info given in
graphics
Change the position of benefits- i.e.
1st gold ribbon, then silver, etc.
Idea of placebo may be confusing
See above re oestrogen only
11
12-13
Harms– p17-21
DA Page
Recommended Change
Gold level evidence IS listed
first
See consumer comments
Action
No Specific changes from practitioners on this section
Graphs– p 12-15
7 18-21
DA Page
Recommended Change
Action
18-19
Breast cancer is only a concern after
4 years HRT, need to state this
Vertical dots clear, more contrast
Evidence shows increased risk
is associated with current use
Changes made as per
many
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RFT 063/0304
many
many
Sydney Health Decision Group: HRT Decision Aid
between colours needed
5 year focus ambiguous, dislike
wording {inline with FG comment
below, re-word/explain further?}
Info for women in their 50’s, actually
refers to women in their 60’s for
cardiovascular results – {check and
change?}
consumer comments
Text associated with graphics
reworded for improved clarity.
See consumer comments
Cardiovascular risks now
included in
uncertain/inconclusive category
of evidence
DA Page
Recommended Change
STEP 1 & STEP 2 – p26-30
DA Page
Recommended Change
Action
Clarify that HRT increases everyone’s
risk of breast cancer, and further
increases your risk if you have a
family history
Worksheet , p31- 32
This section has been
substantially revised. See
consumer comments
DA Page
Action
29
Recommended Change
31
31
31
Action
Prefer cued worksheet
Prefer blank worksheet
Hesitant about including heavy
periods/irregular bleeding in “relief
from menopausal symptoms” prompt
31
High level of literacy required to fill
this section out, although certainly has
a place
31
Women may feel guilty for taking HRT
for what are seemingly trivial reasons
when there are risks - make statement
about this
31
Not important to important scale is
difficult – not sure how helpful
Need to add blank pages for clinician
to write a personalized action plan
Information , p33
Adopted
Adopted
Removed as per working party
and consumer comments
DA Page
Action
Recommended Change
33
Reading age within
recommended range
Not an issue raised within
consumer groups.
Consumers found this helpful.
Included as new section
Add Australasian Menopause Society
link (www.menopause.org.au) and
Jean Hale’s foundation
Alternatives to HRT Appendix p34-36
NHMRC to add approved
websites and resources
DA Page
Recommended Change
Action
34-36
Need to mention alternatives won’t
improve bone density
34-36
Black Cohosh & vit e are not phytooestrogens.. wording confusing . reword
Minimal information available in
literature on alternatives. No
evidence about bone density for
many of them. Symptom relief is
the major issue under
consideration.
Reworded
46
RFT 063/0304
34-36
34-36
Sydney Health Decision Group: HRT Decision Aid
Comment antidepressants are for hot
flushes, not for depression in this
circumstance
Add information about Tibolone
No phytooestrogens statistics
Need to in same format as HRT info
e.g. numbers per 1000
Wording changed
We have included this as a form
of HRT so should not then call it
an ‘alternative’
No evidence available
References Appendix
DA Page
Recommended Change
Action
37-39
Not necessary –direct to website or
provide phone number instead
Women wanted to know more
about how to access this
information
As above
Women won’t use them, but
strengthens document
Graphics/cover layout/ visual issues
37-39
DA Page
Recommended Change
Action
47
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Sydney Health Decision Group: HRT Decision Aid
APPENDIX 5 Laminated Cards
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Laminated Card 1
Of 1000 women in their 50’s who DO take
Drug A, over five years:
4 women may have a
heart attack
103 women may develop
breast cancer
Of 1000 women in their 50’s who DO take
Drug A, over five years:
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4 women may have a
heart attack
103 women may
develop breast cancer
48
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
4 women may have a
heart attack
103 women may develop
breast cancer
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Of 1000 women in their 50’s who DO take
Drug A, over five years:
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RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Laminated Card 2
Of 1000 women in their 50’s who DO take
Drug A, over five years:
4 women may have a
heart attack
103 women may develop
breast cancer
49
RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Laminated Card 3
Of 1000 women in their 50’s who DO take
Drug A, over five years:
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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4 women may have a
heart attack
25 women may
develop breast cancer
132 women may have
a stroke
25 women may
develop breast cancer
Of 1000 women in their 50’s who DO take
Drug A, over five years:
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
4 women may have a
heart attack
132 women may
have a stroke
50
RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Laminated Card 4
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Of 1000 women in their 50’s who DO take
Drug A, over five years:
300 women’s hot
flashes improve
700 women’s hot
flashes unchanged
2 broken hips or
colon cancers
2 strokes or blood
clots
2 breast cancers
300 women’s hot
flashes improve
700 women’s hot
flashes unchanged
2 broken hips or
colon cancers
2 strokes or blood
clots
2 breast cancers
Of 1000 women in their 50’s who DO take
Drug A, over five years:
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
300 women’s hot
flashes improve
700 women’s hot
flashes unchanged
2 broken hips or
colon cancers
2 strokes or blood
clots
2 breast cancers
300 women’s hot
flashes improve
700 women’s hot
flashes unchanged
2 broken hips or
colon cancers
2 strokes or blood
clots
2 breast cancers
51
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
4 women may have a
heart attack
25 women may
develop breast cancer
132 women may have
a stroke
25 women may
develop breast cancer
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Of 1000 women in their 50’s who DO take
Drug A, over five years:
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Laminated Card 5
Of 1000 women in their 50’s who DO take
Drug A, over five years:
4 women may have a
heart attack
132 women may
have a stroke
52
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
4 women may have a
heart attack
103 women may develop
breast cancer
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Laminated Card 6
Of 1000 women in their 50’s who DO take
Drug A, over five years:
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
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●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
RFT 063/0304
Sydney Health Decision Group: HRT Decision Aid
Of 1000 women in their 50’s who DO take
Drug A, over five years:
4 women may have a
heart attack
103 women may develop
breast cancer
53