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International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

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Introduction A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. Methods and analysis This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. Ethics and dissemination This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.
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1
KlassenAF, etal. BMJ Open 2018;8:e025435. doi:10.1136/bmjopen-2018-025435
Open access
International phase I study protocol to
develop a patient-reported outcome
measure for adolescents and adults
receiving gender-afrming treatments
(the GENDER-Q)
Anne F Klassen,1 Manraj Kaur,1 Natasha Johnson,1 Baudewijntje PC Kreukels,2
Giancarlo McEvenue,3 Shane D Morrison,4 Margriet G Mullender,5 Lotte Poulsen,6
Mujde Ozer,5 Will Rowe,1 Thomas Satterwhite,7 Kinusan Savard,8 John Semple,9
Jens Ahm Sørensen,6 Tim C van de Grift,5 Maeghan van der Meij-Ross,5
Danny Young-Afat,10 Andrea L Pusic11
To cite: KlassenAF, KaurM,
JohnsonN, etal. International
phase I study protocol to
develop a patient-reported
outcome measure for
adolescents and adults receiving
gender-afrming treatments
(the GENDER-Q). BMJ Open
2018;8:e025435. doi:10.1136/
bmjopen-2018-025435
Prepublication history for
this paper is available online.
To view these les, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2018-
025435).
Received 16 July 2018
Revised 3 August 2018
Accepted 18 August 2018
For numbered afliations see
end of article.
Correspondence to
ProfessorAnne FKlassen;
aklass@ mcmaster. ca
Protocol
© Author(s) (or their
employer(s)) 2018. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Introduction A critical barrier to outcome assessment
in gender-afrming healthcare is the lack of a specic
patient-reported outcome measure (PROM). This phase I
protocol describes an international collaboration between
investigators in Canada, Denmark, the Netherlands and
the USA who have coalesced to develop a new PROM (ie,
the GENDER-Q) to evaluate outcomes of psychological,
hormonal and surgical gender-afrming treatments.
Methods and analysis This phase I study uses an
interpretive description approach. Participants aged 16
years and older seeking any form of gender-afrming
treatments in centres located in Canada, Denmark,
the Netherlands and the USA will be invited to take
part in qualitative interviews. Participants will review
BREAST-Q and FACE-Q scales hypothesised to contain
content relevant to specic gender-afrming treatments.
Interviews will elicit new concepts for additional scale
development. Each interview will be digitally recorded,
transcribed and coded. The main outcome of this phase I
study will be the development of a conceptual framework
and set of scales to measure outcomes important to
evaluating gender-afrming treatments. To this end,
analysis will be used to add/drop/revise items of existing
scales to achieve content validity. For new concepts,
coding will assign top-level domains and themes/
subthemes to participant quotes. Codes will be used to
develop an item pool to inform scale development. Draft
scales will be shown to transgender and gender diverse
persons and experts to obtain feedback that will be used
to rene and nalise the scales. The eld-test version of
the GENDER-Q will be translated by following rigorous
methods to prepare for the international eld-test study.
Ethics and dissemination This study is coordinated
at McMaster University (Canada). Ethics board approval
was received from the Hamilton Integrated Ethics Board
(Canada), the Medical Ethical Committee at VUmc (The
Netherlands) and Advarra (USA). Findings will be published
in peer-reviewed journals and presented at national and
international conferences and meetings.
INTRODUCTION
The World Professional Association for Trans-
gender Health (WPATH) is an international,
multidisciplinary association that promotes
evidence-based care, education, research,
advocacy and public policy in transgender
and gender diverse healthcare.1 As WPATH
policies set the standard for clinical deci-
sion-making in the care of gender diverse
individuals, the development of patient-cen-
tred outcome tools that measure issues that
matter to persons from their perspectives was
called for by the WPATH board in an open
letter dated May 2018.2
Gender-affirming treatments are multi-
faceted and can directly impact appearance
and how individuals function and feel. Such
treatments have been shown to alleviate
gender dysphoria and allow people who are
Strengths and limitations of this study
Recruitment of an international sample of partic-
ipants will make it possible to identify concepts
that are common to people seeking gender-afrm-
ing treatments who live in different countries and
cultures.
The inclusion of adolescents and adults will enable
us to identify concepts that are common across age.
To enhance rigour, we adhere to published guide-
lines for determining content validity of existing
scales, development of new scales and translation/
cultural adaptation of patient-reported outcome
measures in other languages.
We use a modern psychometric approach to ensure
GENDER-Q scales are clinically meaningful and sci-
entically sound.
on 21 October 2018 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2018-025435 on 21 October 2018. Downloaded from
2KlassenAF, etal. BMJ Open 2018;8:e025435. doi:10.1136/bmjopen-2018-025435
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transgender or gender diverse to live more comfortably
with their bodies.3–5 Globally, a rapidly increasing number
of individuals are seeking gender-affirming care. Concur-
rent with increasing demand, treatments are becoming
more individualised as the concept of gender is increas-
ingly recognised as existing along a continuum rather
than binary.6 7 These changes make access to tools to
enable shared decision-making and the assessment of
care increasingly important.8
A current barrier to outcome assessment in gender-af-
firming healthcare is the lack of a specific patient-re-
ported outcome measure (PROM) designed to evaluate
treatment outcomes from the patient perspective. This
barrier was highlighted in two recent systematic reviews,
both of which identified that existing PROMs used in
transgender surgery research are inadequate and called
for new measures to be developed.9 10 The development
of a specific PROM is crucial because how someone
feels and functions before and after gender-affirming
treatments are concepts best assessed by self-report.11
Furthermore, outcomes of treatments to alleviate feelings
of gender incongruence are not measured by generic
PROMs, including the 36-Item Short Form Health
Survey,12 which have been used to study gender-affirming
surgery. Assessing outcomes that matter to patients, such
as improvements in sexual well-being and body image
after gender-affirming treatment,13–15 is essential to
understanding the impact and success of treatments.
Specific scales are needed to cover the full range of
gender-affirming treatments. Our team recently devel-
oped two scales to measure the appearance of the chest
and nipples as a supplement to the BODY-Q.16 These
scales were field-tested in an international (Canada,
the USA, Denmark, the Netherlands) sample of 739
participants with different chest indications, including
gynaecomastia, weight loss and gender-affirming chest
surgery.17 To develop these scales, we used a modern
psychometric approach to create clinically meaningful
and scientifically sound PROM scales with high content
validity.18 19 We followed international best practice guide-
lines that outline the latest methods for PROM develop-
ment and validation, including guidelines for establishing
content validity and special considerations for younger
persons.11 20–23 We followed a three-phased mixed methods
approach that we previously published24 and is repro-
duced in figure 1. This three-phased approach ensures
that a new PROM fulfils minimum standards regarding
reliability and validity as described by the International
Society for Quality of Life Research25 and the Consen-
sus-based Standards for the Selection of Health Status
Measurement Instruments.26 27 Briefly, in phase I, using
qualitative methods, a pool of items was generated. The
item pool was developed into scales that were shown to
patients and experts for feedback. This step ensured that
the content of the new scales comprehensively measured
outcomes that matter to patients and that instructions,
response options and items were clear, meaningful and
unambiguous. In phase II, the scales were field-tested in
a large international sample. The items in each scale that
represented the best indicators of outcome were identi-
fied and retained based on their performance against a set
of psychometric criteria according to Rasch Measurement
Theory (RMT) analysis.18 In this approach, the qualitative
phase was crucial because the data were used to create,
for each scale, a set of items that together mapped out
a concept of interest on a clinical hierarchy.19 The RMT
analysis was used to determine if the theorised concepts
were supported by the field-test data (ie, fit of the data to
the Rasch model). In phase III, patients are being invited
to participate in a prospective study to measure change
following gender-affirming chest surgery. Anchor-based
and distribution-based methods will be used to examine
responsiveness.
The following protocol describes an international collab-
oration between investigators in Canada, Denmark, the
Netherlands and the USA who have coalesced to develop
a new PROM for evaluating outcomes of gender-affirming
treatments. The chest and nipples scales represent the first
step in our programme of research to develop a compre-
hensive set of scales covering all types of gender-affirming
treatments. Our overarching objective is to build on the
chest and nipples scales to create a comprehensive PROM
that is valid and reliable for use in research, quality improve-
ment initiatives and in clinical care with individual patients
seeking gender diverse healthcare treatments.
METHODS AND ANALYSIS
This protocol describes the phase I qualitative study to
develop a set of independently functioning scales to eval-
uate gender-affirming treatments. We take an applied
health services research approach called Interpretive
Description.28 29 This approach aims to generate knowl-
edge relevant to the clinical context and presumes there
is theoretical knowledge, clinical knowledge and a scien-
tific basis informing a study.
We will conduct a series of interviews that will involve
two parts. In part 1, we will adapt existing BREAST-Q30
and FACE-Q31 32 scales hypothesised to have relevant
content by adding/dropping/revising items as needed.
In part 2, we will develop scales for new concepts elicited.
We previously used this two-part approach to establish
content validity for existing scales and develop new scales
for the FACE-Q Module for Children, and Young Adults
described elsewhere.33
To establish content validity of existing scales, we follow
guidance from the USA Food and Drug Administra-
tion (FDA),11 which recommends that new qualitative
work, similar to that conducted when developing a PROM,
can provide evidence of content validity for existing tools
if patient interviews or focus groups are conducted using
open-ended methods to elicit participant input. Our team
will use cognitive interviews to identify relevant content
within BREAST-Q and FACE-Q scales and open-ended
interviews to identify new concepts for scale development.
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Sample
Participants will be purposively sampled to include a
maximum variety of age, gender and treatment history
(psychological, hormonal or surgical). Participants will
be recruited by someone within the circle of care from
each participating site or through local support groups.
Contact details for those who express an interest in the
study will be passed on to a member of the research team
to schedule interviews. Participants will be recruited
from the interdisciplinary clinic for transgender youth
at McMaster Children’s Hospital (Canada), the McLean
Clinic (Canada), Women College Hospital (Canada),
Aalborg University Hospital (Denmark), VU University
Medical Center (Netherlands), Brownstein & Crane
Surgical Services (USA) and Align Surgical Associates
(USA). We do not anticipate problems recruiting the
necessary participants given the transgender focus and
high volume of patients at these sites, as well as the
expressed need for such a measure by the population
themselves. Interviews will be conducted face-to-face or
by phone depending on participant preference and logis-
tics for travel.
Part 1: cognitive interviews
Sample size requirements for cognitive interviews are
variable, with the number of interviews a function of
the complexity of the PROM and the diversity of the
population.34 For the review of existing BREAST-Q and
FACE-Q scales, the FDA document advises the following
for adapting an existing PROM for a new patient popu-
lation: 'The sample size depends on the completeness of
the information obtained from analysis of the transcripts.
Figure 1 Flow diagram showing the multiphase mixed methods protocol for developing the GENDER-Q. Reproduced with
permission from Wong Riff et al.24 QUAN, quantitative.
on 21 October 2018 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2018-025435 on 21 October 2018. Downloaded from
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Open access
Generally, the number of patients is not as critical as inter-
view quality and patient diversity included in the sample
in relation to intended clinical trial population charac-
teristics’.11 We will conduct as many cognitive interviews
as are necessary to establish content validity for existing
scales. Cognitive interviews will use the ‘think aloud’
method with probing to obtain feedback on all aspects of
each scale.35 36 Cognitive interviews are valuable for iden-
tifying missing content as well as tailoring existing item
wording, item format and presentation to ensure respon-
dents optimally understand them.
Breasts
Hormonal treatment can lead to breast development
for some transgender and gender diverse women,37 but
breast augmentation is often needed. The BREAST-Q is a
PROM with separate modules for different types of breast
surgery, including augmentation. The BREAST-Q was
developed using interview data from 48 women, refined
through focus groups and interviews involving 88 women,
and field-tested with 908 presurgery and 1807 postsurgery
women from Canada and the USA.30 The BREAST-Q has
close to 50 translations and is used worldwide in clinical
practice, quality improvement/benchmarking initia-
tives38 39 and research.40 The BREAST-Q has been used
in research with transgender women41 42 even though its
development did not include any transgender or gender
diverse individuals. We will identify relevant content
within the BREAST-Q augmentation module to provide
a means to measure satisfaction with breasts for trans-
gender and gender diverse women. We hypothesise that
some BREAST-Q items will be retained, some will need to
be modified or dropped, and new items or scales may be
needed.
Face
Male and female faces differ in obvious ways, especially the
shape of the forehead, hairline, nose, lips, cheeks, chin,
jawline, neck and facial hair. For transgender women,
facial hair removal and facial feminisation surgery provide
a means to achieve an appearance that is better aligned
with gender identity.43 The FACE-Q aesthetic module31 32
has 23 scales that measure the appearance of the face
and specific facial areas. These scales were developed
from 50 interviews with patients who were pre-treatment
or post-treatment for surgical and minimally invasive
aesthetic treatments and input from 26 experts. Scales
were refined through 35 cognitive interviews and field-
tested in a sample of 988 cosmetic patients from Canada,
the USA and the UK. Development of FACE-Q did not
include people who are transgender or gender diverse.
To provide scales that can be used to evaluate the effect
of gender-affirming treatments on facial appearance, we
will adapt the FACE-Q scales that measure face overall
and features that differ the most between males/females,
including the cheeks, chin, forehead, hairline, jawline,
lips, neck and nose. Cognitive interviews will be used
to determine whether the scales have content validity
for people who are transgender or gender diverse. We
hypothesise that in each scale, some items will be retained,
some will need to be modified or dropped and new items
or scales will be needed.
Part 2: concept elicitation
Scale review will be immediately followed by a qualita-
tive interview to elicit new concepts not covered by the
BREAST-Q and FACE-Q. An interview guide (see box 1)
will be used to guide the interviews. Topics included
in the guide were informed by PROMs reviewed in
two recent systematic reviews of outcomes following
gender-affirming treatments,9 10 and other phase I plastic
surgery-specific PROM development studies performed
by our team. The qualitative interviewer will dynamically
adapt the interview as needed (eg, for younger partici-
pants) to avoid asking irrelevant questions or questions
that might be too personal for some to discuss (eg, sexual
well-being). As interviews progress, the interview guide
will be iteratively adapted to include new concepts iden-
tified. Sampling and recruitment will continue until the
point of saturation is reached, that is, no further new
concepts are elicited from additional interviews.44
Data analysis
Both parts of the interviews will be digitally recorded and
transcribed verbatim. Interviews performed in Denmark
and the Netherlands will be translated into English prior
to coding. Data collection and analysis will take place
concurrently to build on the knowledge gained from
each interview. Transcripts will be coded using a line-by-
line approach by one member of the research team and
confirmed by a second member. Codes and data will be
pasted into an Excel spreadsheet for analysis. For existing
scales, feedback on the instructions, response options and
items will be sorted by the scale/item number and exam-
ined to establish content validity for the existing scales by
making necessary modifications. To develop new scales,
patient quotes (participant words/phrases) from the
semi-structured interviews that pertained to any aspect
of outcome will be categorised into top-level domains
and themes/subthemes. Qualitative analysis will lead to
the refinement of a conceptual framework covering the
concepts that matter to people seeking gender-affirming
treatments. This framework will be used to guide scale
development.
The coded material will be used to develop a compre-
hensive item pool within Excel. Items will retain partici-
pant-specific wording to ensure they are easy to understand
and resonate with patients. As much as possible, positive
or neutral wording will be adopted for items to minimise
any negative impact of completing scales. The item pool
will be analysed and used to develop a comprehensive set
of independently functioning scales covering key aspects
of the conceptual framework. Each scale will be assigned
instructions and the most appropriate time frame and set
of response options.
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Open access
Box 1 Semi-structured interview guide
Part 1: review of BREAST-Q and FACE-Q scales
Instructions
What are the instructions asking you to do? Please explain in your
own words.
Is the time frame for responding to the scale appropriate?
Are there any words we should change to make the instructions
easier?
Items
In your own words, what is this item is asking?
What do you think of when answering this item?
Are any words difcult to understand or offensive?
Was this item hard or easy to answer and why?
Does this item measure an important issue for you?
What do you think about the response choices?
At the end of each scale
In your own words, what is this group of items asking about?
Does this group of items measure an important issue for you?
Are there any items that donot belong with the rest?
Thinking about that group of items, what are we missing?
At the end of the interview
What are your overall thoughts about the questionnaire?
Is there anything we forgot to ask that is important to patients seek-
ing treatment?
Is there anything we should change about our questionnaire?
Is there anything else that you would like to add or comment on?
Part 2: concept elicitation for new scales
Experience of care
Can you tell me about the rst time you asked for professional help
with your gender identity?
Can you tell me about the events that led to your decision to seek
treatment?
Have you experienced any barriers to obtaining gender-afrming
treatments?
What are the people like who have cared for you? Probe: helpful,
friendly, expertise, skill.
What kind of information and advice were you given by healthcare
providers? Probe: amount, content, interactions.
How could healthcare professionals improve the quality of care pro-
vided to you?
Treatments and recovery
What kinds of gender-afrming treatments have you had so far?
Probe: psychological, hormonal, surgical.
What was the recovery like from surgical treatments? Probe: symp-
toms and impact on activities and daily life.
What was good/bad about each gender-afrming treatment you
have had?
How happy/satised are you with each gender-afrming treatment
you have had?
Do you plan to have any gender-afrming treatments in the future?
If yes, which ones?
Appearance
How important is your appearance to you?
To what extent is your appearance aligned with your gender
identity?
How would you describe your appearance? Probe: face/body/hair/
other.
What do you like/dislike about the appearance? Probe: face/body/
hair/other.
Continued
Box 1 Continued
Has your appearance changed with any gender-afrming treat-
ments and how? Probe: face/body/hair/other.
Is there anything else about your appearance that you would like to
change? Probe: face/body/hair/other.
Voice
How important is how your voice sounds to you?
To what extent is your voice aligned with your gender identity?
How would you describe your voice?
What do you like/dislike about your voice?
How has your voice changed with any gender-afrming treatments
and how? Probe: do people respond to you differently?
Psychological
How do you generally feel? Probe: negative (anxiety, depression, ir-
ritation) and positive (happy, post-traumatic growth).
Does distress interfere with daily activities and how? Probe: work,
social, dating.
Has your emotional health changed with any gender-afrming treat-
ments and how?
Which gender-afrming treatments have helped the most in terms
of emotional well-being?
Body image
How do you feel about your face/body/hair/other? Probe: negative
(self-conscious, uncomfortable, unattractive, abnormal) and positive
(condent, attractive, normal).
Do you hide or cover parts of your body or face or modify your voice
to blend in? Probe for how and why.
To what extent is your body image in line with your gender identity?
Has your body image changed with any gender-afrming treat-
ments and how?
Which gender-afrming treatments have helped the most in terms
of body image?
Social
What has it been like for you socially? Probe: school, work, friends,
family, dating.
Can you describe the kinds of emotional, informational and instru-
mental support you receive from your social network?
Have you experienced any bullying, teasing, abuse, stigmatisation
or discrimination? Probe: school, work, friends, family, dating and
coping strategies.
Are there things you want to do in life but donot because of gen-
der-specic issues?
Has your social life changed with any gender-afrming treatments
and how? Probe: school, work, friends, family, dating.
Which gender-afrming treatments have helped the most in terms
of your social life?
Physical
To what extent is your physical function aligned with your gender
identity? Probe: mobility, strength, activities.
How has your physical function changed with the gender-afrming
treatments? Probe: mobility, strength, activities.
Which gender-afrming treatments have helped the most in terms
of physical function?
Sexual
How important is your sexual life and well-being to you?
How do you feel about your body sexually? Probe: positive (con-
dent, attractive, normal) and negatives (self-conscious, uncomfort-
able, unattractive, abnormal) and clothed/unclothed.
Can you tell me about any problems or concerns with the sexual life
related to your gender identity?
Continued
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Scale renement
Refinement of new scales will take place using the same
approach as described for existing scales, with multiple
rounds of cognitive interviews using the ‘think aloud’
technique.35 36 Participants who took part in the initial
interviews will be invited to take part in scale refine-
ment. These interviews will be digitally recorded, tran-
scribed and analysed to identify problematic items,
response options and instruments. Before the final
round of scale review by participants, the GENDER-Q
will be shown to experts in transgender and gender
diverse healthcare for feedback. The goal is to ensure
that we have not overlooked any important concepts.
We will design a survey using Research Electronic Data
Capture, a secure web-based data collection system.45
Experts from around the world identified from our
professional circles will be invited by email to provide
feedback on existing content and to suggest missing
content. Any changes suggested by experts will be
reviewed in a final round of participant interviews to
ensure that the field-test version of the GENDER-Q is
composed of a set of scales that are easy to understand
and comprehensively measure outcomes that matter to
transgender and gender diverse people.
Translations
In preparation for an international field-test, the
GENDER-Q will be translated into languages needed by
participating sites. We will follow the methodology that
was recommended for translations of PROMs in the field
of plastic surgery, which we already applied to other
PROMs developed by members of our team (eg, BODY-
Q,46 CLEFT-Q47). This approach is in accordance with
the International Society for Pharmacoeconomics and
Outcomes Research48 and the World Health Organiza-
tion49 recommendations for linguistic validations. Briefly,
the translation will follow a rigorous process that involves
two independent forward and one backward translation,
an expert panel meeting and a series of cognitive patient
interviews. The goal is to obtain a culturally adapted and
equivalent translation of the GENDER-Q that is easily
understood in the target language.
Subsequent phases
We will apply for grant funding to conduct phase II
and III studies. The phase II field-test study will involve
recruitment of a large international sample of partici-
pants. We will use the data collected to refine and validate
GENDER-Q scales using RMT analysis.18 Our goal will be
to identify the subset of items for each scale that represent
the best indicators of outcome resulting in shorter clini-
cally meaningful and scientifically sound scales. Items for
retention will be identified based on their performance
against a set of psychometric tests that are described in
detail elsewhere.19 Once developed and validated, we
will conduct further psychometric research to determine
each scales’ ability to measure clinical change following
gender-affirming treatments (phase III studies).
Patient and public involvement
Our patient-oriented approach engages transgender
and gender diverse people and healthcare providers in
all stages of our research as experts and research team
members whose input is crucial to the design of the study
and development of content for GENDER-Q scales. All
participants in the initial qualitative interviews will be
invited to continue to collaborate in our study by taking
part in scale refinement interviews where they can
provide feedback on our findings and help to refine the
final set of scales. At the VUmc hospital, regular meet-
ings for transgender individuals are held to update them
on the outcomes of conducted research. For all partici-
pants, we will disseminate feedback in the form a news-
letter with links and information about presentations and
publications.
ETHICS
Each participant will provide written and oral consent
before participating. Given that transgender and gender
diverse people can experience gender dysphoria and
report higher than average rates of depression and suicide
ideation,50–54 it could prove upsetting to participants to
talk about their experiences. As necessary, we will provide
a list of support services within the city and put patients
in touch with a healthcare provider at the recruiting site
to obtain support. Patient data will be de-identified at the
transcription phase. All data will be kept secure and confi-
dential following institution rules for data storage.
DISSEMINATION
To ensure uptake, once the GENDER-Q is developed,
it will be made available free of charge to all non-profit
users. Our team will seek to raise awareness and
promote its use among stakeholders including patients,
researchers, healthcare practitioners, decision-makers
and policy-makers. To this end, our dissemination initia-
tives will include face-to-face interactions as well as elec-
tronic and hard-copy media, all effective strategies for
research uptake.55 We will seek out opportunities to
Box 1 Continued
In what ways has gender-afrming treatment changed your genita-
lia? Probe: appearance, function.
Has your sexual life changed with any gender-afrming treatment
and how? Probe: frequency, quality, drive, arousal.
Which gender-afrming treatments have helped the most in terms
of your sexual life?
Additional questions
Can you describe any other concerns or issues you experienced that
we have not already covered?
Thinking back over this interview, what are the most/least important
issues that we have talked about?
on 21 October 2018 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2018-025435 on 21 October 2018. Downloaded from
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KlassenAF, etal. BMJ Open 2018;8:e025435. doi:10.1136/bmjopen-2018-025435
Open access
deliver presentations at national and international meet-
ings. We will publish findings for the GENDER-Q in high
impact journals that we know to be valued and read by
our target audiences. Finally, we will use social media (eg,
Twitter, Instagram) to spread awareness of our work to
our network of followers.
Author afliations
1McMaster University, Hamilton, Ontario, Canada
2Department of Medical Psychology, Amsterdam Public Health research institute,
Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam,
The Netherlands
3McLean Clinic, Mississauga, Ontario, Canada
4Division of Plastic Surgery, Department of Surgery, University of Washington
Medical Center, Seattle, Washington, USA
5Department of Plastic Reconstructive and Hand Surgery, Amsterdam Public Health
Research Institute, Center of Expertise on Gender Dysphoria, VU University Medical
Center, Amsterdam, The Netherlands
6Department of Plastic and Reconstructive Surgery, Odense University Hospital,
Odense, Denmark
7Brownstein & Crane Surgical Services, Greenbrae, California, USA
8Fleming College-Emeritus, Peterborough, Ontario, Canada
9Women’s College Hospital, Toronto, Ontario, Canada
10Amsterdam University Medical Centers, Amsterdam, The Netherlands
11Brigham and Women’s Hospital, Boston, Massachusetts, USA
Contributors AFK, MK, NJ, GME, SM, MGM, MO, LP, WR, TS, KS, JSe, JSo, ALP
conceived and designed the study. AFK, MK, NJ, BPCK, GME, SM, MGM, MO, LP,
WR, TS, KS, JSe, JSo, TCvdG, MvdM-R, DY-A, ALP revised the article critically for
important intellectual content and have approved the nal version to be published.
Funding Phase I of this study is funded by research grants received from the
Canadian Institutes for Health Research (CIHR), the Plastic Surgery Foundation and
ZonMw (project number 636330001). The authors have no nancial interest to
declare in relation to the content of this article. The Article Processing Charge was
paid from a CIHR grant.
Competing interests None declared.
Patient consent Not required.
Ethics approval This study has been approved by the Hamilton Integrated
Research Ethics Board (HiREB). Institutional review board approval has also been
obtained in the Netherlands by the Medical Ethical Committee at VUmc, and in
the USA by Advarra for Brownstein & Crane Surgical Services and Align Surgical
Associates.
Provenance and peer review Not commissioned; peer reviewed for ethical and
funding approval prior to submission.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
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on 21 October 2018 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2018-025435 on 21 October 2018. Downloaded from
... Transgender and gender-diverse [TGD] individuals experience an incongruence between their assigned birth sex and current gender identity [1]. Gender dysphoria (GD) is defined as the psychological distress that accompanies the incongruence between expressed gender and the assigned sex from birth [1][2][3][4]. The distress is intensified by the historical and social stigmatization and discrimination of TGD individuals, who experience higher rates of depression, anxiety, substance abuse, high-risk sexual behaviors, and suicidal ideation in comparison to cis individuals [5][6][7][8][9]. ...
... TGD individuals may seek gender-affirming medical interventions known to develop physical characteristics that align with their gender identity or gender embodiment goals [10]. These interventions have been shown to reduce gender dysphoria by allowing TGD individuals to live more comfortably in their bodies [3]. Treatment interventions may include gender-affirming hormone replacement therapy (HRT), surgery [to change appearance and function], speech modification and communication therapy, and hair procedures [removal, scalp advancement, transplantation]. ...
... In 2018, the World Professional Association for Transgender Health (WPATH), an internationally recognized multidisciplinary association, issued the need to develop a PROM specific to the TGD population. This PROM would enable individuals, clinicians, healthcare systems, and advocacy groups to better evaluate genderaffirming healthcare services, measure outcomes, and gain a deeper understanding of the impacts, successes, and shortcomings of treatments [3]. Similarly, several other studies [14][15][16][17][18] concluded an absence of validated PROMs for the TGD populations, as many of the current ones are focused on GD and gender identity as opposed to outcome measures for gender-based care [11]. ...
Article
Full-text available
Background Globally, the number of individuals identifying as transgender and gender-diverse [TGD] has grown in the last decade. This study aimed to perform a Danish linguistic translation and cultural adaptation of the GENDER-Q, a new patient-reported outcome measure [PROM] designed to evaluate outcomes of gender-affirming care. Methods The field test version of the GENDER-Q (959 items) was translated into Danish using guidelines from the International Society of Pharmacoeconomics and Outcomes Research and the World Health Organization to ensure accuracy, cultural relevance, and validity. This included two forward translations, a backward translation, an expert panel meeting, and two rounds of patient cognitive interviews. Results The forward translations resulted in revisions of 142 items, which were then harmonized to form the backward translation version. A comparison of the back translation to the original questionnaire led to a total of 43 changes to items and response options. The revised version was reviewed in an expert panel meeting and minor changes were made with 28 patient participants using cognitive debriefing interviews. The translated version was proofread, resulting in the Danish translation of the GENDER-Q. Conclusions The GENDER-Q was translated and culturally adapted for use in the Danish TGD adult population. The GENDER-Q has the potential to enhance the understanding and improvement of treatment and health-related quality-of-life outcomes for adults seeking gender-affirming care. Level of Evidence Not gradable.
... This shift, along with a growing emphasis on shared decision-making and outcome assessment, reiterates the importance of tools that support these practices. 7,8 Although gynecological surgeries such as hysterectomy are more commonly chosen among TMGD (41%) compared to genital surgeries (7%), most studies often focus on the outcomes of genital surgeries, whereas the impact of gynecological surgeries on TMGD remains understudied. 9 Since most studies on gynGAS focus on surgical outcomes, little is known about motivation, subjective experiences, and the effect of these interventions on dysphoria and quality of life. ...
Article
Background Although many transmasculine individuals undergo 1 or more gynecological surgeries (ie, hysterectomy, oophorectomy, tubectomy, or colpectomy), little has been published about motivation, subjective experiences, and the effect on dysphoria and quality of life. Aim The aim of this study was to acquire an in-depth understanding of patients’ motivations and experienced outcomes of gynecological gender surgery. Methods In this qualitative study, in-depth semi-structured interviews were conducted. Nine participants were included who were: on the waiting list for their first gynecological surgery (n = 2), or who had either undergone gynecological surgery as part of their transitioning (ie, hysterectomy) and were on the waiting list for another gynecological procedure (ie, colpectomy, n = 2), or who had undergone gynecological surgery and did not wish to undergo any further surgeries (n = 5). In-depth semi-structured interviews were conducted. Topics discussed were motivation to opt for a specific surgery, expectations, and experiences. Thematic analysis was carried out to compose themes from the interview transcripts using the concepts of body image and gender affirmation as a theoretical lens. Outcomes The primary outcomes of this study were composed themes based on thematic analysis of the interview transcripts. Results Three subthemes were identified, displaying how gynecological surgeries could contribute to gender affirmation: body representation matching oneself; achieving functional congruence; and enabling further surgical transition. Clinical implications This study offers valuable insights for healthcare professionals in patient counseling and shared decision-making and provides a foundation for developing patient-reported outcome measures tailored to transmasculine individuals. Strengths and Limitations To our knowledge, this is the first qualitative report to study the motivations for and outcomes of gynecological gender-affirming surgeries in such depth; however, the results cannot be directly applied to other settings without considering the local context, including factors such as legislation and insurance policies. Conclusion This study highlights how gynecological surgeries, unlike more visible gender-affirming procedures like chest surgeries, address internal conflicts related to the masculine identity by altering the body’s functioning, thereby playing an important role in the process of gender affirmation.
... A protocol paper describing the development of the GENDER-Q has been previously published [9]. The development of GENDER-Q follows internationally established guidelines for PROM development [3,[10][11][12] and consists of two main steps: (1) development of a field test version of the GENDER-Q, and (2) psychometric evaluation of the GENDER-Q. ...
Article
Full-text available
Background To meaningfully understand outcomes of gender-affirming care, patient-reported outcome measures (PROMs) that are grounded in what matters to individuals seeking care are urgently needed. The objective of this study was to develop a comprehensive PROM to assess outcomes of gender-affirming care in clinical practice, research, and quality initiatives (the GENDER-Q). Methods Internationally established guidelines for PROM development were used to create a field test version of the GENDER-Q. In-depth interviews were conducted from December 2018 to March 2020 with youth and adults aged 16 years and older who were seeking or had received gender-affirming care at outpatient clinics providing gender-affirming care located within tertiary care centers or communities in Canada, Denmark, the Netherlands or the US. Data were analyzed and used to develop a conceptual framework and an item pool, which was used to develop preliminary scales. Between February 2021 to November 2021, iterative feedback was sought from clinicians and patient participants on the scales and used to refine or develop new scales. The revised scales were pilot-tested using a crowd-sourcing platform between February 2022 and April 2022. Results Data from interviews with 84 participants (aged 34 ± 14 years) resulted in a conceptual framework of the GENDER-Q with 13 domains measuring health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Preliminary versions of 44 scales were developed covering most concepts in the conceptual framework. Iterative feedback was obtained from clinician experts (4 to 37 experts per scale; response rate, 67%) and 7–14 patient participants (depending on scale). All scales were refined, and 15 new scales were developed, resulting in 55 scales in the field test version of the GENDER-Q. In total, 601 transgender and gender diverse (TGD) people (aged 25 ± 6 years) participated in the pilot field test and the data were used to make changes to the field test survey. Conclusion The GENDER-Q was developed using extensive input from TGD individuals and clinician experts and represents the most comprehensive set of independently functioning scales that are available to date. An international field test of the GENDER-Q was completed in 2024 and the GENDER-Q is available for use in patient care, clinical research and quality improvement efforts.
... Apart from breast cancer patients, other patient populations in plastic and reconstructive surgery have also benefited from the implementation of a standardized tool, namely the transgender population with the introduction of the GENDER-Q, released in April 2023 [46]. The validation and implementation of this tool helped to improve access to gender-equitable care [47,48]. This is an impressive demonstration of how a standardized approach to QoL assessment makes it possible to synthesize data across studies, enabling a coherent and standardized approach to the care of a patient population [10]. ...
Article
Full-text available
Background: Patient-reported outcome measures (PROMs) have gained increased importance in assessing outcomes after reconstructive surgery. This also applies to the reconstruction of vulvoperineal defects after resection of gynecological or colorectal cancers in women. The objective of this study is to analyze the current state of PROM tool use within this patient population. Methods: By systematic literature searches in Embase, Medline, and Web of Science, English-language studies published after 1980, including randomized controlled trials, cohort studies, and case series reporting on vulvoperineal defect reconstruction, which were included if they also analyzed quality of life (QoL) and/or PROMs. The PROM tools used by each study were extracted, analyzed, and compared. Results: The primary search yielded 2576 abstracts, of which 395 articles were retrieved in full text. Of these, 50 reported on vulvoperineal defect reconstruction, among which 27 studies analyzing QoL were found. Of those, 17 met the inclusion criteria for this systematic review. After full-text screening, 14 different PROM tools and 5 individual, non-standardized questionnaires were identified. Only 22% of studies used a validated PROM tool. Conclusion: Far too few studies currently use PROM tools to assess outcomes in oncological vulvoperineal defect reconstruction. Less than half of the used PROMs are validated. No PROM was designed to specifically measure QoL in this patient population. The standardized implementation of a validated PROM tool in the clinical treatment of this patient population is an essential step to improve outcomes, enable the comparison of research, and support evidence-based treatment approaches.
... Currently, a new PROM, the GENDER-Q, used to assess the outcomes of all types of gender-affirming care (e.g., surgery, hormones, speech/language therapy) is in phase II and could be used in future studies of higher surgery [23,24]. ...
Article
Full-text available
During the last decade, the demand for top surgery in female-to-male transgender (FMT) has increased worldwide. This study aims to present our initial experience with the novel use of ultrasound-assisted liposuction (UAL) in top surgery. Additionally, we evaluate the satisfaction and quality of life with TRANS-Q and BREAST-Q. We conducted a retrospective study analyzing FMT undergoing UAL in top surgery from 2019 to 2021 at a single institution. We analyzed demographic variables, comorbidities, surgical techniques, operative time, complications, and follow-up time. We used TRANS-Q and BREAST-Q to evaluate patient-reported outcomes. A p value < 0.05 was considered significant. We performed 34 UAL combined subcutaneous mastectomies in 17 patients. Twelve patients (70.6%) underwent mastectomy double incision with free nipple grafting (DIFNG), and 29.4% underwent concentric circular mastectomy. In the DIFNG group, BMI (p < 0.02), the weight of each mammary gland (p < 0.001), and use of chest binder (p < 0.03) were significantly higher. The mean operative time was 115 min. The complication rate was 11.7% (one hematoma and three hypertrophic scars). The mean follow-up was 29.4 months, and no aesthetic revision surgeries was reported. The response rate for TRANS-Q and BREAST-Q was 76.5%, and high satisfaction with the results and significant improvement in quality of life were reported. We present the first cohort of transgender men who underwent UAL in top surgery. With proper training, the use of UAL could be a feasible and safe technique, offering good long-term esthetic results. Additionally, TRANS-Q and BREAST-Q demonstrated improved satisfaction and quality of life. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Article
Genioplasty is frequently performed in facial feminization surgery, typically aiming to reduce chin height and projection for more feminine appearance. Quantification of the bony changes occurring during surgery have to date not been published. This study presents a method for segmentation of the chin using CT imaging to quantify changes to the chin after feminization genioplasty. CT scans of 21 patients before and after feminization genioplasty were segmented in Mimics to isolate the chin region. Surface area, volume, vertical chin projection, and horizontal chin projection were measured before and after surgery. Patient outcomes were evaluated using the FACE-Q and World Health Organization Quality of Life patient-reported outcome measures. Surface area, volume, and vertical chin projection demonstrated statistically significant decreases after surgery. The magnitude of changes in surface area and vertical chin projection were significantly associated with their presurgical values. In particular, patients with greater presurgical vertical projections experienced greater decreases in vertical projection after surgery, with some patients having increases in postsurgical vertical projection. Patient FACE-Q scores improved significantly on all scales, including chin, jawline, and neck satisfaction. This study demonstrates a method for evaluating bony changes on CT scan after feminization genioplasty. The measured changes cohere with the changes expected to create a more feminine chin. Furthermore, changes created by feminization genioplasty are in the context of the patient’s overall facial harmony and are not uniform across all patients.
Article
Introduction Gender‐affirming genital surgery is one of several surgical procedures available to transgender and nonbinary (TGNB) individuals to improve congruence between their gender identity and sex assigned at birth. Despite increasing utilization of these procedures, patient‐reported outcome measures (PROMs) to assess subjective outcomes following gender‐affirming genital surgery remain limited. Our aim was to provide a synopsis of PROMs currently being used to evaluate urinary outcomes among TGNB patients following gender‐affirming genital surgery and to assess each PROM for content that is relevant to TGNB patients. Methods A multidatabase search was performed (Embase and PubMed) using search terms that included transgender , patient‐reported outcome measures, questionnaire, and gender‐affirming surgery. Studies that assessed subjective outcomes related to urinary outcomes and pelvic floor dysfunction following gender‐affirming genital surgery were reviewed. Gender‐affirming genital surgery included vaginal reconstruction (vaginoplasty) and penile reconstruction (phalloplasty and metoidioplasty). Included studies were evaluated for relevant content items and summarized in table. Results Our literature search identified 820 unique articles. Twenty‐seven full articles were included in the final review. Until recently, measurement tools have been limited to unvalidated ad hoc questionnaires or PROMs developed for other conditions, such as urinary incontinence or vaginal prolapse, that are validated among the predominantly cisgender general population. Of the selected studies, PROMs used to evaluate urinary and pelvic floor dysfunction following gender‐affirming genital surgery included self‐construced ad hoc questionnaires (10 studies), Amsterdam Overactive Pelvic Floor Scale (four studies), King's Health Questionnaire (two studies), Pelvic Floor Distress Inventory (PFDI)−20 (two studies), Sheffield Pelvic Organ Prolapse (one study), International Consultation on Incontinence Questionnaire‐Urinary Incontinence (ICIQ‐UI) (one study), and ICIQ‐Female Lower Urinary Tract Symptoms (one study). The PFDI‐20 asked about the most relevant symptoms to TGNB patients following genital surgery; however, not all cisgender validated questionnaires included important questions about voiding position, splayed or misdirected stream. The Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) questionnaire is the first PROM for assessing subjective urinary outcomes that are validated for TGNB individuals, and the GENDER‐Q is a promising new PROM with the aim of evaluating outcomes following surgical and other gender‐affirming treatments. Conclusion Despite recent advancements, a need remains for standardized assessment tools to evaluate pelvic floor dysfunction and urinary symptoms following gender‐affirming genital surgery. Questionnaires developed for the general population to assess symptoms of pelvic organ prolapse and other urinary dysfunction do not fully capture the experiences unique to TGNB individuals undergoing this type of surgery. Nonetheless, PROMs validated specifically for TGNB individuals are necessary to more accurately evaluate outcomes of gender‐affirming genital surgery, allow for informed patient counseling, and create evidence‐based changes to improve these interventions.
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Background Cleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual’s appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain. Methods The CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed. ResultsThe field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions. Conclusion Translation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved.
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We examined the role of gender confirming treatment (i.e., hormonal treatment and genital surgery; GCT), psychological well-being, and body satisfaction in the sexual feelings and behaviors of transgender adults. A survey was conducted among a non-clinical sample of 325 male-to-female and 251 female-to-male Dutch adults (17-76yr, Mage = 41.87), divided into those with no GCT desire, those who desired (more) GCT, and those who completed GCT. Findings indicated that whereas GCT may positively affect sexual feelings, particularly in MtF's, body satisfaction may play an even bigger role. Those without a GCT desire may experience particular difficulties to their sexual experiences.
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This review provides an update on the epidemiology of gender dysphoria and transgender identity in children, adolescents and adults. Although the prevalence of gender dysphoria, as it is operationalised in the fifth edtion of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), remains a relatively 'rare' or 'uncommon' diagnosis, there is evidence that it has increased in the past couple of decades, perhaps reflected in the large increase in referral rates to specialised gender identity clinics. In childhood, the sex ratio continues to favour birth-assigned males, but in adolescents, there has been a recent inversion in the sex ratio from one favouring birth-assigned males to one favouring birth-assigned females. In both adolescents and adults, patterns of sexual orientation vary as a function of birth-assigned sex. Recent studies suggest that the prevalence of a self-reported transgender identity in children, adolescents and adults ranges from 0.5 to 1.3%, markedly higher than prevalence rates based on clinic-referred samples of adults. The stability of a self-reported transgender identity or a gender identity that departs from the traditional male-female binary among non-clinic-based populations remains unknown and requires further study.
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Background: Plastic surgery to improve chest appearance is becoming increasingly popular. The BODY-Q is a patient-reported outcome (PRO) instrument designed for weight loss and/or body contouring. In this paper, we describe the development of a new module for masculinizing chest contouring surgery. Methods: Qualitative methods were used to develop and refine the content of the BODY-Q Chest Module, which was subsequently field-tested in Canada, USA, Netherlands and Denmark between June 2016 and June 2017. Participants were men and trans men aged 16 years or older and seen for gynecomastia, weight loss or trans men chest surgery. Data were collected using either a web-based application or paper questionnaire. Rasch Measurement Theory (RMT) analysis was performed. Results: The sample included 739 participants (i.e., 174 gynecomastia, 224 weight loss, 341 gender confirming). RMT analysis refined a 10-item chest and 5-item nipple scale. All items had ordered thresholds and good item fit, and scales evidenced reliability, i.e., Person Separation Index and Cronbach's alpha values were 0.95 and 0.98 (chest scale) and 0.87 and 0.94 (nipple scale). Scores for both scales correlated more strongly with similar (satisfaction with the body) versus dissimilar (psychological and social function) BODY-Q scales. The mean score for the chest and nipples scales was significantly higher (p<0.001 on independent samples t-tests) in participants who were post-operative compared with pre-operative at the time of assessment. Conclusion: This new BODY-Q Chest Module is a clinically meaningful and scientifically sound PRO instrument that can be used to measure outcomes for masculinizing chest contouring surgery.
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Background: The usefulness of patient-reported outcome measures is emphasized along with the development of patient-centered care. When implementing patient-reported outcome measures, evidence of the instrument's validity, reliability, and responsiveness in the target population is necessary to secure accurate reporting of the patient's experience. The aim of this study was to identify the literature in which structured patient-reported outcome measures have been used to evaluate the results of gender confirmation surgery, and to systematically evaluate the validity of these instruments. Methods: A systematic review of the current literature was performed to identify structured patient-reported outcome measures used to evaluate the outcome of gender confirmation surgery. The identified instruments' validity in the transgender population was assessed for adherence to international guidelines for development and validation of health outcomes instruments. Results: A total of 110 instruments were identified: 64 ad hoc; six generic; 24 evaluating psychiatric, social, or psychosocial aspects; nine evaluating function but only valid in other patient groups; five ad hoc with some formal development/validation; and two specific for gender dysphoria. Conclusions: There is a lack of patient-reported outcome measures that are valid for the transgender population and concurrently sensitive enough to evaluate gender confirmation surgery without the influence of other gender confirming interventions. Basing research on instruments without confirmed validity decreases the validity of the study itself; thus, previous research using patient-reported outcome measures to evaluate gender confirmation surgery can be considered to have a low level of evidence. To obtain valid patient-reported outcome measures, specific for evaluating the results of gender confirmation surgery, development of new instruments or adaptation of existing instruments is needed.
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Background: Chest reconstruction in many female-to-male (FTM) transgender individuals is an essential element of treatment for their gender dysphoria. In existing literature, there are very few longitudinal studies utilizing validated survey tools to evaluate patient reported outcomes surrounding this surgery. The purpose of our study is to prospectively evaluate patient reported satisfaction, improvement in body image, and quality of life following FTM chest wall reconstruction. Methods: Our study was a prospective analysis of FTM patients who underwent chest reconstruction by a single surgeon (C.A.) between April 2015 and June 2016. The patients were surveyed preoperatively and 6 months after surgery utilizing the BREAST-Q breast reduction/mastectomy questionnaire and the Body Uneasiness Test (BUT-A). Analysis was performed on their self-reported demographic information, survey results, and chart review data. Results: Of 87 eligible patients, 42 completed all surveys and could be linked to their chart data. From the BREAST-Q surveys, significant improvements were observed in the domains of breast satisfaction, psychosocial well-being, sexual satisfaction, and physical well-being. From the BUT-A surveys, we observed significant improvement in body image, avoidance, compulsive self-monitoring, and depersonalization. Groups with mental health conditions had poorer initial BUT-A scores and greater degree of improvement after surgery. Conclusions: As the prevalence of gender affirming surgery increases and as health policies are being developed in this area, the need for evidence-based studies surrounding specific interventions is essential. This study demonstrates significant improvement in a number of quality of life measurements in FTM patients after undergoing chest masculinization surgery.
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Context Breast development is a key feature of feminization and therefore important to transwomen (male-to-female transgender persons). However, it is not exactly known when breast development starts after initiating cross-sex hormone therapy (CHT) and how much growth may be expected of CHT alone. Objective To investigate breast development in centimeters and bra cup-sizes in transwomen during their first year of CHT, and whether clinical or laboratory parameters predict the breast development. Design This study was performed as part of the European Network for the Investigation of Gender Incongruence (ENIGI), which is a prospective multicenter cohort study. Setting Specialized gender clinics in Amsterdam, Ghent, and Florence. Participants All transwomen who completed the first year of CHT (n=229) were eligible for analyses. Intervention Cross-sex hormone therapy. Main outcome measures Breast development in centimeter and cup-size. Results The median age of the included transwomen was 28 years (range 18;69 years). Mean breast – chest difference increased from 4.1±2.9cm at baseline to 7.9±3.1cm after one year of CHT, mainly resulting in less than an AAA cup-size (48.7%). Main breast development occurred in the first six months of therapy. Serum estradiol levels did not predict breast development after one year CHT (first quartile: +3.6cm(95% CI +2.7;+4.5cm), second quartile: +3.2cm(95% CI +2.3;+4.2cm), third quartile: +4.4(95% CI +3.5;+5.3cm), fourth quartile: +3.6cm(95% CI +2.7;+4.5cm)). Conclusion This study shows that after one year of CHT breast development is modest and occurs primarily in the first six months. No clinical or laboratory parameters were found that predict breast development.
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Appearance and facial function are concepts not well addressed in current pediatric patient-reported outcome measures (PROM) for facial conditions. We aimed to develop a new module of the FACE-Q for children/young adults with facial conditions that include ear anomalies, facial paralysis, skeletal conditions, and soft tissue conditions. Semi-structured and cognitive interviews were conducted with patients aged 8–29 years recruited from craniofacial centers in Canada, USA, UK, and Australia. Interviews were used to elicit new concepts and to obtain feedback on CLEFT-Q scales hypothesized to be relevant to other facial conditions. Interview data were recorded, transcribed, and coded. Experts were emailed and invited to provide feedback via Research Electronic Data Capture (REDCap). Eighty-four participants and 43 experts contributed. Analysis led to the development of a conceptual framework and 14 new scales that measure appearance, facial function, health-related quality of life, and adverse effects of treatment. In addition, 12 CLEFT-Q scales were determined to have content validity for use with other facial conditions. Expert input led to minor changes to scales and items. This new FACE-Q module for children/young adults is being field-tested internationally. Once finalized, we anticipate this PROM will be used to inform clinical practice and research studies.