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

Abstract

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.

Full text

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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.
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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.
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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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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?
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7
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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