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ORIGINAL RESEARCH & REVIEWS

The Informed Consent Model of Care for Accessing Gender-Affirming

Hormone Therapy Is Associated With High Patient Satisfaction

Cassandra Spanos, MD,

1

Julian A. Grace, BASc (Osteopathy),

2

Shalem Y. Leemaqz, PhD,

3

Adam Brownhill, BM BS, MRCGP, FRACGP, FARGP,

2

Pauline Cundill, BM, FRACGP,

2,4

Peter Locke,

2

Peggy Wong, MBBS, FRACGP,

2

Jeffrey D. Zajac, MBBS, FRACP, PhD,

1

and

Ada S. Cheung, MBBS (Hons), FRACP, PhD

1

ABSTRACT

Background: There are 2 common approaches to assess an individual before commencing of gender-affirming

hormone therapy (GAHT); a mental health practitioner assessment and approval or an informed consent model

undertaken with a primary care general practitioner (GP).

Aim: In a primary care clinic practising an Informed Consent Model of care to initiate GAHT, we aimed to

firstly describe the proportion and characteristics of patients referred for secondary consultation to a mental

health practitioner (MH referred) and secondly, we aimed to measure patient satisfaction.

Methods: A retrospective audit of all new patients with a transgender or gender diverse identity presenting to a

primary care clinic in Melbourne, Australia was performed between March 2017 and March 2019. In those

newly seeking GAHT, de-identified data were obtained including presence of secondary mental health practi-

tioner referral, time to GAHT commencement and co-occurring mental health conditions. A separate survey

assessed patient satisfaction.

Outcomes: Mental health conditions and overall patient satisfaction in those referred for secondary mental

health consultation (MH referred) were compared with those who were not (GP assessed).

Results: Of 590 new consultations, 309 were newly seeking GAHT. Referrals for secondary mental health

assessment before GAHT occurred in 8%. The GP-assessed group commenced GAHT at median 0.9 months

(0.5e1.8) after initial consultation compared with 3.1 months (1.3e4.0), P<.001 in the MH-referred group.

The MH-referred group was more likely to have post-traumatic stress disorder (adjusted P¼.036) and

schizophrenia (adjusted P¼.011). Of 43 respondents to the survey, a higher proportion in the GP-assessed

group was extremely satisfied with their overall care compared with the MH-referred group (P<.01).

Notably, 80% in the GP-assessed group chose to seek mental health professional support.

Clinical Implications: Initiation of GAHT can be performed in primary care by GPs using an informed consent

model and is associated with high patient satisfaction. Mental health professionals remain a key source of support.

Strengths & Limitations: This retrospective audit did not randomize patients to pathways to initiate GAHT.

Follow-up duration was short. Responder bias to survey with low response rates may overestimate patient

satisfaction. This is one of the first studies to evaluate an informed consent model of care.

Conclusion: More widespread uptake of an informed consent model of care to initiate GAHT by primary care

physicians has the potential for high patient satisfaction and may be a practical solution to reduce waiting lists in

gender clinics. Spanos C, Grace JA, Leemaqz SY, et al. The Informed Consent Model of Care for Accessing

Gender-Affirming Hormone Therapy Is Associated With High Patient Satisfaction. J Sex Med

2020;XX:XXXeXXX.

Copyright 2020, The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Key Words: Informed Consent Model; Transgender; Gender-Affirming Hormone Therapy; Mental Health

Received July 27, 2020. Accepted October 24, 2020.

1

Department of Medicine, Austin Health, The University of Melbourne,

Heidelberg, Victoria, Australia;

2

Equinox Gender Diverse Health Centre, Thorne Harbour Health, Fitzroy,

Victoria, Australia;

3

College of Medicine and Public Health, Flinders University, South Australia,

Australia;

4

Pandanus Medical NT, Millner, Northern Territory, Australia

Copyright ª2020, The Authors. Published by Elsevier Inc. on behalf of

the International Society for Sexual Medicine. This is an open access

article under the CC BY-NC-ND license (http://creativecommons.org/

licenses/by-nc-nd/4.0/).

https://doi.org/10.1016/j.jsxm.2020.10.020

J Sex Med 2020;-:1e81

INTRODUCTION

Transgender health care is a rapidly growing area of medicine,

with increasing demand for services currently seen worldwide.

However, there is a lack of research to guide how to assess an

individual before commencement of gender-affirming hormone

therapy (GAHT). There is considerable debate regarding tradi-

tional modes of assessment involving a formal mental health

practitioner, compared with an alternative informed consent

model of care that involves a shared decision-making process

between a treating clinician and a transgender (including gender

diverse and non-binary) (TGD) individual seeking GAHT.

The World Professional Association for Transgender Health

Standards of Care were first published in 1979 and represent one

of the earliest international consensus statements about the

optimal management of TGD individuals.

1

Currently, in its 7th

version published in 2012, the World Professional Association

for Transgender Health Standards of Care recommend a psy-

chosocial assessment conducted by a mental health professional

(in most cases, a gender-specific psychiatrist or psychologist) as

the first step for a TGD individual seeking hormone therapy and

outline criteria for hormone prescribing that include a require-

ment for “persistent, well-documented gender dysphoria”.

1

However, the requirement for formal mental health practi-

tioner approval has come under scrutiny from some members of

the TGD community for being paternalistic, without scientific

evidence for benefit, and the process is perceived to be “a form of

gatekeeping that actually limits access to gender-affirming

care”.

2e8

The informed consent model of GAHT prescription

emerged in the early 2000s with the intention of depatholo-

gizing gender diversity and reducing barriers to medical care

for TGD individuals.

1,3,4,8

Its hallmark is a shift from the

requirement for formal psychiatric approval before accessing

GAHT to a shared decision-making process between the pa-

tient and their treating clinician.

8

The primary treating clini-

cian assesses an individual’s ability to provide informed consent

and then provides thorough education around GAHT placing

the patient as the primary decision maker in partnership with

their treating clinician. The informed consent model seeks to

emphasize partnership and self-determination to tailor care to

individual needs and reduce unnecessary barriers in accessing

GAHT.

9

Typically, the primary treating clinician (general

practitioner [GP], sexual health physician or endocrinologist)

will initiate GAHT as long as the patient is able to fully un-

derstand the potential benefits, known risks and unknown risks

of GAHT, and has capacity to provide consent.

8

Secondary

referral to mental health professionals to provide support or

counseling may occur but is not mandated. Notably, the

informed consent model is acknowledged within the World

Professional Association for Transgender Health Standards of

Care as an accepted alternative pathway in the provision of

GAHT

1

and recognized in more recent position statements

from professional societies.

10,11

The informed consent model at Equinox Gender Diverse

Health Centre comprised the following 5 stages: (i) introduction

to clinic services; (ii) initial medical review and referral for sec-

ondary consultation if required; (iii) hormone counseling and

education; (iv) initiation of HRT; and (v) ongoing monitoring

and support, with care provided by a primary care physician

(GP).

9

The model is flexible, allowing for individualization based

on the unique needs of each patient, and encourages the con-

current use of mental health supports as required.

Given a lack of data regarding implementation of informed

consent models of care for GAHT use, at our primary care clinic

specializing in TGD health, we aimed to first describe the pro-

portion of patients referred for secondary mental health practi-

tioner assessment before initiating GAHT; second, to describe

predictors that triggered referral for formal mental health prac-

titioner assessment before commencing GAHT; and third, to

measure patient satisfaction. We hypothesized that those who

underwent assessment solely by their GP would initiate GAHT

earlier and be more satisfied with their care than those referred

for secondary formal mental health practitioner assessment before

initiation of GAHT.

METHODS

A retrospective audit was performed of new consecutive con-

sultations at Equinox Gender Diverse Health Centre between

March 2017 and March 2019. Electronic medical records were

reviewed collaboratively by 2 coauthors C. S. and J. G., and

deidentified data were recorded. A separate cross-sectional

anonymous patient satisfaction survey available as a hard copy

in the clinic waiting room and online (Qualtrics Survey Software

[Utah]) via the clinic Facebook page was conducted between

May and June 2019 to measure patient satisfaction. The study

received ethical approval by the Austin Health Research Ethics

Committee and Community Research Endorsement Panel

(approval number THH/CREP/19/016).

The Equinox Gender Diverse Health Centre (hereafter known

as Equinox) in inner city Melbourne, Australia, is a primary care

clinic specifically serving the TGD population since February

2016. Equinox is a peer-led TGD clinic offering services in

medicine, osteopathy, counseling, and social work. There is a

TGD advisory committee working in conjunction with a practice

manager to guide the operations of the clinic. All reception staff are

TGD community members. Several clinical staff also identify as

TGD. There are no out-of-pocket costs for a patient to see a doctor

at Equinox with all consultations subsidized by the Australian

Government (Medicare bulk-billed). Patients are able to self-

initiate appointments with the primary care physicians (GPs).

Equinox created Australia’sfirst informed consent protocol for

initiation of GAHT in 2017, which were endorsed by the

Australian Professional Association for Trans Health and the only

existing state public tertiary care gender service, Monash Gender

Clinic.

12

The model was based on similar protocols used at Callen-

J Sex Med 2020;-:1e8

2Spanos et al

Lorde Community Health Center in New York, United States,

13

and primary care physicians implemented these informed consent

model of care guidelines in practice in February 2017 for all

attending patients.

9

The Equinox informed consent model does

not state or guarantee that all patients will commence GAHT after

the GP assessment alone. It does state that the GP will perform an

initial assessment for all patients and the GP will refer patients for

secondary mental health practitioner assessment in the settings of

more complex mental health conditions such as psychosis or if the

GP feels unable to adequately determine an individual’s ability to

provide informed consent.

All new patient consultations at Equinox were reviewed

retrospectively. New consultations were divided into 5 groups to

ascertain individuals who were initiated on GAHT at Equinox:

(i) individuals who were assessed solely by a GP before initi-

ating GAHT at Equinox (“GP-assessed”group);

(ii) individuals who were initially assessed by a GP and then

referred for secondary formal mental health practitioner

assessment before initiating GAHT at Equinox (“MH-

referred”group);

(iii) individuals who had a preexisting formal mental health

assessment and initiated GAHT at XEquinox;

(iv) individuals who were already taking GAHT; and

(v) individuals who did not commence GAHT during the

period of follow-up.

To compare characteristics of individuals who were assessed

solely by a GP and individuals who were assess by a GP and then

referred for secondary mental health practitioner assessment,

comparisons were made between groups (i) and (ii).

Deidentified data were collected including age at first pre-

sentation, postcode, birth-assigned sex, gender identity, and date

of first consultation. Postcodes were classified as per the

Australian Standard Geographical Classification eRemoteness

Areas (ASGC-RA)

14

to assess rural status. Diagnosed medical

and mental health conditions were extracted from electronic

medical records as entered by treating clinicians. Birth-assigned

sex and gender identity were self-reported on self-designed

intake forms (question stated “Please indicate your gender

identity/expression”with options to circle including female,

male, trans, sistergirl, brotherboy, genderqueer, transfeminine,

transwoman, transmasculine, transman, non-binary, prefer not

to say, and/or “other [please specify]”with a free text section).

In addition, referrals to mental health professionals (psychia-

trist or psychologist), number of clinic visits before GAHT

commencement, and proportion of patients who returned for

review at 3 and 12 months after initiation were recorded (if

eligible to do so) during the follow-up period.

The patient satisfaction survey is included in full in the

Appendix 1. Participants were asked whether they had initiated

GAHT under the IC model and asked to rate their satisfaction

across a number of domains. Key questions included “How

satisfied were you with the information provided regarding risks/

benefits of hormone therapy by your treating doctor?”“How

satisfied have you been with the opportunity to ask questions

during your consultations with your doctors at Equinox?”“Did

you feel that you were actively involved in the decision-making

process to start hormones?”“Have you accessed mental health

support during your transition?”and “How satisfied were you with

the process or steps required to start gender-affirming hormones

(either at Equinox or elsewhere)?”Responses were provided on a 5-

point Likert scale (extremely satisfied, moderately satisfied, neither

satisfied nor dissatisfied, moderately dissatisfied, and extremely

dissatisfied). Owing to sparse responses, the latter 4 categories were

grouped as one “not extremely satisfied”category and compared

with extremely satisfied responses in the statistical analysis. Par-

ticipants were also provided with a free-text comment box

regarding their care received at Equinox.

Statistical Analysis

Demographics of patients are reported as frequencies and per-

centages (n [%]) for categorical variables and median and interquartile

range for continuous variables. The number of co-occurring mental

health conditions was compared between patients who were referred

for mental health assessment and those who underwent the IC model

of care using Wilcoxon rank-sum test. Further analysis of each mental

health condition was compared separately using Chi-squared tests or

Fisher’s exact test where cell counts are low, with Bonferroni adjusted

P-values for multiple comparisons reported. The median and inter-

quartile range of the time to commence hormonal treatment and

number of appointments before hormonal treatment between pa-

tients with and without referral for mental health assessment was also

reported and compared using Mann-Whitney U test. The patient

satisfaction survey responses were summarized into frequencies and

percentages separately for each question, and Fisher’s exact test was

used to compare the extremely satisfied responses to not extremely

satisfied (moderately satisfied or less). Statistical analyses were per-

formed using R, version 3.6.1 (R foundation for statistical

computing).

RESULTS

Demographics

In total, 589 new patients had new consultations at Equinox

between 01 March 2017 and 28 February 2019. Their mean age

was 25 years (21e30). Based on ASCG-RA criteria, 90% were

from major cities, 9% from inner regional areas, and 1% from

outer regional areas. There were 52% who were assigned female

at birth, 46% were assigned male at birth, and the remaining 2%

preferred not to say. In terms of gender identity, 39% identified

as female, transfemale, or trans feminine, 31% as male, trans-

male, or transmasculine, 27% had a non-binary or genderqueer

identity, and 3% were unassigned.

Referral for Mental Health Assessment

Of all new consultations, 53% (n ¼309) initiated GAHT at

Equinox, 21% (n ¼126) were already taking GAHT, and the

J Sex Med 2020;-:1e8

Informed Consent Model in Transgender Health 3

Table 1. Characteristics that predicted referral for secondary mental health practitioner consultation before commencing GAHT

Characteristic

Informed consent

group (n ¼566) MH-referred group (n ¼23) Total (n ¼291) Pvalue

(Bonferroni)

Adjusted Pvalue

Depression: N (%) .8872 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 151 (56.3) 14 (60.9) 165 (56.7)

Yes 114 (42.5) 9 (39.1) 123 (42.3)

Anxiety: N (%) .1274 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 175 (65.3) 11 (47.8) 186 (63.9)

Yes 90 (33.6) 12 (52.2) 102 (35.1)

ADHD: N (%) .6659 1.0000

Missing 2 (0.7) 0 (0.0) 2 (0.7)

No 248 (92.5) 21 (91.3) 269 (92.4)

Yes 18 (6.7) 2 (8.7) 20 (6.9)

Borderline personality disorder: N (%) .0367 .4400

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 252 (94.0) 19 (82.6) 271 (93.1)

Yes 13 (4.9) 4 (17.4) 17 (5.8)

Autism spectrum disorder: N (%) .3697 1.0000

Missing 2 (0.7) 0 (0.0) 2 (0.7)

No 252 (94.0) 21 (91.3) 273 (93.8)

Yes 14 (5.2) 2 (8.7) 16 (5.5)

Post-traumatic stress disorder: N (%) .0030 .0362

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 260 (97.0) 19 (82.6) 279 (95.9)

Yes 5 (1.9) 4 (17.4) 9 (3.1)

Substance abuse/dependency: N (%) 1.0000 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 256 (95.5) 23 (100.0) 279 (95.9)

Yes 9 (3.4) 0 (0.0) 9 (3.1)

Schizophrenia: N (%) .0009 .0112

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 262 (97.8) 19 (82.6) 281 (96.6)

Yes 3 (1.1) 4 (17.4) 7 (2.4)

Bipolar disorder: N (%) 1.0000 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 257 (95.9) 23 (100.0) 280 (96.2)

Yes 8 (3.0) 0 (0.0) 8 (2.7)

OCD: N (%) 1.0000 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 262 (97.8) 23 (100.0) 285 (97.9)

Yes 3 (1.1) 0 (0.0) 3 (1.0)

Eating disorders: N (%) 1.0000 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 262 (97.8) 23 (100.0) 285 (97.9)

Yes 3 (1.1) 0 (0.0) 3 (1.0)

Schizoaffective disorder: N (%) 1.0000 1.0000

Missing 3 (1.1) 0 (0.0) 3 (1.0)

No 263 (98.1) 23 (100.0) 286 (98.3)

Yes 2 (0.7) 0 (0.0) 2 (0.7)

ADHD ¼attention deficit hyperactivity disorder; GAHT ¼gender-affirming hormone therapy; MH-referred ¼referred for secondary consultation to a mental

health practitioner.

J Sex Med 2020;-:1e8

4Spanos et al

remaining 26% (n ¼154) did not commence GAHT at

Equinox during the study period. Of the 309 patients who

initiated GAHT at Equinox, 18 had already had a prior mental

health assessment performed by the time they had their first

consultation, leaving 291 individuals newly seeking initiation of

GAHT at their first consultation at Equinox (GP-assessed group

n¼268 [92%], MH-referred group n ¼23 [8%]).

Of the 23 individuals in the MH-referred group, 12 in-

dividuals were referred to a clinical psychologist experienced in

TGD health, 7 individuals to a psychiatrist experienced in TGD

health, and 3 individuals were referred to both a psychologist and

psychiatrist. There was no statistically significant relationship

between the number of co-occurring mental health conditions

and referral for mental health assessment (Wilcoxon rank-sum

test P¼.12) before initiation of GAHT.

Predictors of Mental Health Referral

Table 1 outlines the characteristics of individuals who were in

the GP-assessed group compared with the MH-referred group.

There were 2 conditions that were significantly more prevalent in

those who underwent formal mental health practitioner assess-

ment before accessing GAHT: post-traumatic stress disorder

(PTSD) and schizophrenia (see Table 1).

Time to Commence GAHT

Time taken to commence GAHT (median 3.1 months

[1.3e4.0] for the MH-referred group vs 0.9 months [0.5e1.8]

for the GP-assessed group, P<.001) and the number of ap-

pointments attended before the commencement of GAHT

(median 3 [3.0e4.8] appointments for the MH-referred group

vs 2 [2.0e3.0] appointments for the GP-assessed group,

P<.001) was significantly greater in those referred to a mental

health practitioner than in those of the GP-assessed group.

Long-Term Care

There was no significant difference in the proportion of pa-

tients returning for review appointments; 98% of those in the

GP-assessed group (no information available for n ¼6) and

100% in the MH-referred group returned for review at 3 months

or had documented that they had transferred their care to an

alternative primary care clinic (P¼.235). There were 94% in

the GP-assessed group (no information available for n ¼10) and

100% in the MH-referred group who were still attending for

review after 12 months at Equinox or had documented that they

had transferred their care to an alternative primary care clinic

(P¼.173). One individual in the GP-assessed group had

temporarily stopped GAHT after 10 months of treatment owing

to mental health issues and was planning to restart.

Patient Satisfaction

The anonymous survey was completed by 43 patients. 33 had

accessed GAHT after being assessed solely by a GP, and 10 had

undergone a mental health practitioner assessment before

accessing GAHT. More than 80% of participants in both groups

were overall extremely satisfied or moderately satisfied with the

process required to start GAHT including the information pro-

vision regarding the risks and benefits of GAHT and the ability

to ask questions (Table 2). There was a higher proportion of

individuals in the GP-assessed group who were extremely satis-

fied compared with the mental health referral group (P<.01).

There were otherwise no other statistical differences between

proportions who were extremely satisfied in information provi-

sion, ability to ask questions, and feeling actively involved in the

decision-making process to start hormones (Table 3). Notably,

80% of people accessing GAHT who had been solely assessed by

a GP reported that they had chosen to access additional mental

health support during their transition (Table 3). Participants

were additionally able to provide open comments about their

care at Equinox at completion of the survey, and all comments

are listed in Appendix 2.

DISCUSSION

Our study in a primary care clinic specializing in TGD health

showed that among 309 individuals who were seeking GAHT for

the first time, 92% were assessed solely by their GP. A total of

8% were referred for secondary mental health assessment, the

majority of which were performed by clinical psychologists

specializing in TGD health. The 2 mental health conditions that

predicted referral for secondary mental health assessment were

schizophrenia and PTSD. Not unexpectedly, there was a longer

time between initial consultation and initiation of GAHT in

people referred for a mental health assessment compared with

those assessed solely by their GP. There was no difference be-

tween groups in those attending follow-up review consultations

at 3 months or 12 months after initial consultation. Overall,

patients were highly satisfied with their care at XEquinox, with

those undergoing assessment solely by their GP significantly

more likely to report that they were “extremely satisfied”with the

process compared with those who underwent formal mental

health assessment before initiation of GAHT.

The informed consent model has many theorized benefits as a

physical and emotional harm reduction strategy. Increased up-

take of the informed consent model expands access to treatment,

is suggested to promote patient autonomy, and strengthens

therapeutic relationships.

3,15

As many TGD individuals are so-

cioeconomically disadvantaged, the cost benefits of minimizing

care providers and reducing the number of consultations required

to commence GAHT are significant for the community.

16

Pri-

mary care GPs are well placed to be the first point of call and the

primary provider of long-term gender-affirming care, typically in

conjunction with peer support, mental health support, and other

providers of gender-affirming care such as speech pathologists

and surgeons. Professionals providing GAHT need not be spe-

cialists in mental health but should have mental health experi-

ence, which is in the scope of practice of primary care.

10

J Sex Med 2020;-:1e8

Informed Consent Model in Transgender Health 5

Embedding and normalizing transgender health care into routine

practice will reduce barriers to accessing care. Certainly, it is

evident that GAHT can be initiated in primary care, which is

associated with high levels of patient satisfaction.

Mental Health Assessment

The vast majority (92%) of individuals presenting to Equinox

for GAHT had the capacity to provide informed consent for

GAHT with their primary care physician. The duration of time

from initial visit to commencement of GAHT was significantly

less in the GP-assessed group compared with those referred for

mental health assessment. On average, the wait was 70% shorter

for the GP-assessed group, with an average of 0.9 months be-

tween first appointment and GAHT commencement (median 2

appointments). More traditional pathways of care requiring

psychiatric approval before GAHT prescription have previously

been associated with long wait times.

17

Given the high rate of

mental illness and suicidal ideation when individuals are on

waiting lists to access gender-affirming care, facilitating timely

access to GAHT using the informed consent model may be a

practical approach to potentially reduce psychological

distress

4,15,18,19

and additionally meet the increasing demand for

TGD healthcare services being seen worldwide.

11,20e22

Notably, use of the informed consent model did not preclude

patients from accessing concurrent mental health support, and

80% chose to access counseling or psychological services inde-

pendently of formal referral. Mental health practitioners

continue to be valuable part of the multidisciplinary team and

play a key role in supporting the TGD community. Among our

survey population, there was no significant difference in the

proportion of people accessing mental health support in the GP-

assessed group and mental health referral group (P¼1.00),

indicating that removal of the formal requirement for mental

health review does not discourage pursuit of appropriate mental

health support when the patient feels it is needed. Requirement

for mental health support during such a time of significant

physical and social change is not a reason to delay commence-

ment of GAHT when the patient has the capacity to provide

informed consent.

10

Indeed, the majority (56.3%) of participants

in our GP-assessed group had co-occurring mental health con-

ditions, and this did not impact their capacity to access GAHT

under this model of care.

Predictors of Mental Health Referral

While there may be individual reasons for referral to mental

health practitioners before commencing GAHT, analysis of our

results found that 2 conditions were significantly more prevalent

in the MH-referred group than in the GP-assessed group: PTSD

and schizophrenia. More common conditions such as depression

and anxiety did not predict mental health referral but were

widely prevalent in both the GP-assessed and MH referred

groups. PTSD may be associated with symptoms such as

memory difficulties, distorted cognitions, intrusive thoughts,

avoidance, and arousal symptoms, which in some individuals can

be severe and disabling.

23

Symptoms of schizophrenia such as

psychosis and consequences of schizophrenia such as executive

dysfunction may also potentially hinder informed decision-

making.

24

Both of these conditions can be complex and poten-

tially impair a person’s ability to process information and balance

risks or benefits in order to make an informed decision. In

addition, the need for often multimodal long-term mental health

treatment for PTSD or schizophrenia may well trigger referral to

a specialist mental health professional to optimize a person’s

psychological and social functioning. It is important to note that

the number of individuals in the MH-referred group comprised

only 23 people, and while the findings are hypothesis-generating,

they require further confirmation in other cohorts. Individualized

assessment of capacity for informed decision-making and stability

of co-occurring mental health conditions is required for all

individuals.

Provision of Long-Term Care

Our results demonstrate high numbers of participants were

still returning to the clinic 3 and 12 months after commence-

ment of GAHT, remaining well-connected with their primary

healthcare providers. There was no significant difference between

Table 2. Patient satisfaction survey responses to treatment at Equinox Gender Diverse Health Centre

Group Number

Extremely

satisfied n (%)

Moderately

satisfied n (%)

Neither satisfied

nor dissatisfied

n (%)

Moderately dissatisfied

n (%)

Extremely

dissatisfied n (%)

How satisfied were you with the process or steps required to start gender-affirming hormones (either at Equinox or elsewhere)? (P<.01)

Informed consent group 33 28 (85%) 4 (12%) 0 1 (3%) 0

MH-referred group 10 4 (40%) 4 (40%) 0 1 (10%) 1 (10%)

How satisfied were you with the information provided regarding risks/benefits of hormone therapy by your treating doctor? (P¼.61)

Informed consent group 33 29 (88%) 4 (12%) 0 0 0

MH-referred group 10 8 (80%) 2 (20%) 0 0 0

How satisfied have you been with the opportunity to ask questions during your consultations with your doctors at Equinox? (P¼.56)

Informed consent group 33 29 (88%) 3 (9%) 0 1 (3%) 0

MH-referred group 10 10 (100%) 0 0 0 0

MH-referred ¼referred for secondary consultation to a mental health practitioner.

J Sex Med 2020;-:1e8

6Spanos et al

the return attendance rates for the GP-assessed or the MH-

referred groups. Advocates for the informed consent model

have suggested that the process can increase the quality of long-

term care through promotion of a strong therapeutic relationship

and potentially enabling more honest narratives as TGD people

are not incentivized to provide a stereotyped narrative to fit

diagnostic criteria to access GAHT.

4

Satisfaction

We provide the first survey of patients undergoing an informed

consent model of care to access GAHT, and findings are consistent

with anecdotal evidence that the informed consent model is

appreciated by many in the TGD community.

2,8

There were

extremely high levels of satisfaction with the overall process for

commencement of GAHT. Our data support the informed con-

sent model being able to promote high levels of satisfaction,

excellent engagement of patients in discussions with their health

provider which may lead to strong therapeutic relationships.

3,4,8,15

Limitations

Our study is limited by several factors, the most significant of

which is the retrospective nature of the study. Individuals were

not randomized to the GP-assessed group or the MH-referred

group and we were unable to compare any measures of gender

dysphoria or mental health outcomes before and after GAHT

initiation. Long-term data on continuity of care and their health

outcomes were not collected beyond a maximum of 2 years. This

study was performed at a single practice where primary care

physicians are experienced in TGD health and provide care only

for TGD individuals, which may limit the generalizability of

results to other general primary care settings. Notably, while only

PTSD and schizophrenia predicted referral for secondary mental

health assessment, we note significant overlap between complex

PTSD and borderline personality disorder,

25

and given the na-

ture of the study, formal assessment to confirm mental health

diagnoses were not available. The patient satisfaction survey,

while prospective, was small, voluntary and there may have been

responder bias, leading to overestimation of the level of patient

satisfaction overall.

Response rates were low with only 43 completed surveys (of 309

individuals newly commencing GAHT). However, this is one of the

first studies that has described the characteristics of TGD individuals

undergoing the informed consent model and evaluated patient

satisfaction.

CONCLUSION

More than 90% of individuals presenting to our primary care clinic

had the capacity to provide informed consent for GAHT with their

treating GP. Overall high levels of patient satisfaction were seen,

including in people referred for secondary mental health consultation.

Mental health practitioners continue to play a key supportive role in

the multidisciplinary care of TGD people undergoing GAHT,

particularly in individuals with complex mental health conditions

such as PTSD and schizophrenia. Given increasing numbers of TGD

individualsseeking gender-affirming care worldwide and pressures on

gender clinics, using an informed consent model of care in primary

care clinics may be a practical solution to reduce waiting lists and is

associated with extremely high levels of patient satisfaction. Further

studies evaluating longer-term outcomes in more diverse primary care

settings are required.

ACKNOWLEDGMENTS

Ada Cheung is supported by an Australian Government Na-

tional Health and Medical Research Council Early Career

Fellowship (#1143333).

Corresponding Author: Ada S. Cheung, MBBS (Hons),

FRACP, PhD, Austin Health, 145 Studley Road, Heidelberg,

Victoria 3084, Australia. Tel: þ613 94965000; Fax: þ613

94962980; E-mail: adac@unimelb.edu.au

Conflict of Interest: The authors report no conflicts of interest.

Funding: None.

STATEMENT OF AUTHORSHIP

Adam Brownhill: Conceptualization, Methodology, Investi-

gation, Writing eReview & Editing; P Cundill: Conceptuali-

zation, Writing eReview & Editing; Peter Locke:

Conceptualization, Methodology, Investigation, Writing eRe-

view & Editing; Ada S. Cheung: Conceptualization, Method-

ology, Writing eReview & Editing, Funding Acquisition,

Table 3. Patient satisfaction survey responses to being actively involved in decision-making and accessing mental health support

Group Number Yes n (%) No n (%) Unsure n (%)

Did you feel that you were actively involved in the decision-making process to start hormones? (P¼.21)

Informed consent group 33 33 (100%) 0 (0%) 0 (0%)

MH-referred group 10 8 (80%) 1 (10%) 1 (10%)

Have you accessed mental health support during your transition (including counselors, psychologists, phone services or online chat with

professionals ie, Switchboard)? (P¼1.00)

Informed consent group 33 26 (79%) 6 (18%) 1 (3%)

MH-referred group 10 9 (90%) 1 (10%) 0 (0%)

MH-referred ¼referred for secondary consultation to a mental health practitioner.

J Sex Med 2020;-:1e8

Informed Consent Model in Transgender Health 7

Supervision; Peggy Wong: Methodology, Investigation,

Writing eReview & Editing; Jeffrey D. Zajac: Methodology,

Writing eReview & Editing, Supervision; Shalem Y. Leemaqz:

Formal Analysis, Writing eReview & Editing; Julian A. Grace:

Investigation, Formal Analysis, Writing eReview & Editing;

Cassandra Spanos: Investigation, Formal Analysis, Writing e

Review & Editing.

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SUPPLEMENTARY DATA

Supplementary data related to this article can be found at

https://doi.org/10.1016/j.jsxm.2020.10.020.

J Sex Med 2020;-:1e8

8Spanos et al