9776_commissioning_policy for gender dysphoria services and gender reassignment surgery

					                  HPP 247 – Policy




              COMMISSIONING POLICY
          GENDER DYSPHORIA SERVICES AND
          GENDER REASSIGNMENT SURGERY


Author             Dr. Lookman Alli


Position           Health Intelligence Officer


Policy Lead        Dr. Tamara Djuretic
                   Public Health Consultant

Directorate        Public Health


Date               July 2009


Version            1


Approved By        Individual Cases Panel (ICP)   06.07.09


Review Date        July 2010
                                        CONTENTS PAGE




1. OVERVIEW....................................................................................................... 3
1.1 Policy Statement ............................................................................................. 3
1.2 Background .................................................................................................... 3
2. LEGAL FRAMEWORK ........................................................................................ 6
3. REVIEW OF EVIDENCE ..................................................................................... 7
4. LOCAL COST IMPLICATIONS ........................................................................... 11
5. ELIGIBILITY ................................................................................................... 12
5.1 Eligibility Criteria for Funding ......................................................................... 12
5.2 Exceptionality .............................................................................................. 15
6. PROCESS / NEXT STEPS ................................................................................. 15
6.1 Approval & Ratification Process ..................................................................... 15
6.2 Dissemination ............................................................................................... 15
7. EXISTING GUIDELINES/POSITIONS OF PROFESSIONAL BODIES .......................16
8. APPENDICES ..................................................................................................17
9. REFERENCES..................................................................................................27




Date of policy: July 2009 (v 1)
Date of review: July 2011
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1. OVERVIEW



1.1 Policy Statement

NHS Haringey, as a Primary Care Trust (PCT) have a commitment to meeting the
health needs of its residents and take necessary steps to ensure that those with ill-
health have timely access to necessary medical treatments and care to restore their
health.

The PCT is sensitive to the health needs of the residents of the borough, and
committed to providing effective, evidence-based treatments and care directly
through our providers arm or indirectly through commissioning arrangements with
other providers to our patients who might need such treatments. To do this, we
have established a system for constant surveillance for tracking evidence-based
update for effectiveness of treatments and procedures as well as identifying new
technologies that may be beneficial to our residents.


This policy document is a guidance for which NHS Haringey will consider requests for
gender dysphoria services and gender reassignment surgery. It will apply to all
residents who might benefit from these treatments and procedures. This policy was
put together using available evidence of effectiveness and safety aligned with
national, regional and local guidelines regarding commissioning services for gender
dysphoria and gender reassignment and, like other commissioning policies of the
PCT; it is underpinned by a Framework of Principles available in Individual Funding
Requests Policy.


The objectives of this policy are:

    To have a commissioning guidance in place to ensure consistency in the care of
     people with Gender Dyshoria in whom treatment is appropriate.
    To ensure that patients with Gender Dyshoria who are most likely to benefit from
     treatments are having timely access to the procedures.
    To reduce the waiting times between clinical decisions to treat a patient and the
     actual procedures taking place.


1.2 Background

Gender Dysphoria (GD) or Gender Identity Disorder (GID) is said to be existing when
a person has concerns, uncertainties and questions about gender identity that persist
during their personal development, and becomes so intense that it seems to be the
most important aspect of their life, or prevent them in establishing a relatively


Date of policy: July 2009 (v 1)
Date of review: July 2011
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unconflicted gender identity. The individual’s psychological experience of themselves
as male or female is incongruent with the external sexual characteristic of their body.

The exact aetiology of GID is unknown; several environmental, genetic and
anatomical theories have been described. It is estimated to occur in about 1% of live
births.14 Epidemiological data are limited however, it has been estimated to be
present in 1 in 37,000 males and 1 in 107, 000 females in the United Kingdom.
Figure from Scotland estimates transsexualism to occur in approximately 1 in 12,225
of the adult population.4

The World Health Organization’s International Statistical Classification of Diseases
(ICD-10)4 and, the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)1
offer the following diagnostic criteria:

          Gender Identity Disorder (DSM-IV) is a condition in which there is:

          “a strong and persistent cross-gender identification and a persistent
          discomfort with the sex or a sense of inappropriateness in the gender role of
          that sex”.

          Transsexualism (ICD-10 F64) is experienced when there is:

          “a desire to live and be accepted as a member of the opposite sex, usually
          accompanied by a sense of discomfort with, or inappropriateness of, one’s
          anatomic sex and a wish to have hormonal treatment and surgery to make
          one’s body as congruent as possible with the preferred sex”.

The condition may be diagnosed when:“the transsexual identity has been present
persistently for at least two years”. There are no tests that provide a definitive
diagnosis.

GD treatment is a combination of initial assessment, psychiatric assessment,
psychological support, an aided period of real life experience in the desired gender
and surgical interventions. People with GD vary in the extent to which they feel
dissatisfied with their sexual identity and the extent and permanency of desired
gender.2

Gender Reassignment Surgery involves both the removal of organs relating to the
unwanted gender and the creation of genitalia in the desired gender.2 Operations
relating to the provision of secondary gender characteristics are also sought by
transgender patients. However, health professionals are obliged to assess and
identify patients who will benefit from hormonal and surgical sex-reassignment
treatment. According to the Harry Benjamin International Gender Dysphoria
Association’s Standards of Care for Gender Identity Disorders, ‘any surgical
intervention should not be carried out prior to adulthood, or prior to a real-life
experience of at least two years in the gender role of the sex with which the
adolescent identifies. The threshold of 18 should be seen as an eligibility criterion


Date of policy: July 2009 (v 1)
Date of review: July 2011
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and not an indication in itself for active intervention’.5 The real life experience is
usually precluded by at least 6 months of continuous hormonal treatment.3

GID may be alleviated to a greater or lesser extent by treatment, to the point that
many individuals say that they no longer experience any discomfort, they may,
nonetheless, continue to need hormone therapy and monitoring throughout life. GPs
are usually at the centre of treatment for trans people, often in a shared care
arrangement with other clinicians. GPs may prescribe hormones and make referrals
to other clinicians or services, depending on the needs of the particular service user.4

Most GID patients prefer an approach to treatment that starts with administration of
hormone. Hormone administration, in the short term, is reversible and usually
precedes steps that are largely irreversible, such as living full-time in the opposite
role (the ‘real-life experience’ or RLE) or undergoing genital surgery. Accordingly, the
typical triadic pathway set out in the Harry Benjamin International Gender Dysphoria
Association (HBIGDA) is: hormones ==> real-life experience ==> surgery.5 Clinical
experience indicates that treatment outcomes, using this model or other
combinations of its elements, are good.6 In some patients hormone therapy alone
may provide sufficient symptomatic relief to obviate the need for cross-living or
surgery.5

Gender reassignment procedures are grouped as Core and Non- Core by the Gender
Dysphoria Consortium of London. Core services are those procedures that are
included as services commissioned and paid for by the Gender Dysphoria Consortium
(Appendix 1). Non-Core services are those which may be procured and paid for by
individual PCTs.

In London, patients’ pathway for Gender Identity service is through referral by an
NHS psychiatrist to the West London Mental Health Trust (WLMHT) (Appendix 2).
Referrals must be through the patient’s GP referring them on to an NHS psychiatrist,
who then refers to WLMHT. A patient cannot self-refer and referrals from the private
sector are not accepted.7

In WLMHT, at least two years in the new gender role (known as the Real Life
Experience, RLE) are required before any form of genital surgery would be
considered. Of these two years, at least one is spent in some kind of meaningful full
time occupation. With adherence to these requirements, only one in five male to
female patients undergo gender reassignment surgery (GRS).

This policy outlines NHS Haringey’s funding principles on Gender Dysphoria (Identity
Disorder) services and re- assignment surgery. This document has been put
together using the best available evidence; national and local guidelines and, it is
aimed at improving access to services as well as reducing inequalities in access and
service provision for people with GID.




Date of policy: July 2009 (v 1)
Date of review: July 2011
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2. LEGAL FRAMEWORK


- The Department of Health guidance for NHS health professional published in May
2008 states that: ‘People are entitled to treatment for transsexualism by law as
stated in the case of North West Lancashire Health Authority v A, D & G, Court of
Appeal, 1999. This is not a condition that clinicians may decline to treat’.4

- The House of Lords has confirmed that GID is a bona fide medical condition and
agreed that Primary Care Trusts should make Gender Reassignment Surgery
available to subject to funding and in accordance with normal PCT's prioritisation
process. It is also allowed for PCTs to accord any treatment ‘low priority’.

The House of Lords also places an ‘obligation to treat trans people in accordance
with current best practice and in the light of the most up-to-date research in the
field’.

- The European Court ruling in the cases of Goodwin Vs UK and I Vs UK also places a
responsibility on NHS organisations to treat GID patients.




Date of policy: July 2009 (v 1)
Date of review: July 2011
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3. REVIEW OF EVIDENCE



Literature search were undertaken in 4 electronic databases – Cochrane Library,
Medline, Pubmed, and DARE for current systematic reviews/ RCTs and the following
studies met the inclusion criteria. Trans Gender research appears to be concentrated
on post-surgical outcomes. There are relatively fewer studies on the variety of
outcomes that involve hormone therapy alone, or are combined with an intermittent
or permanent change of gender role.



3.1 Gender Reassignment Surgery
A systematic review of evidence conducted in Sheffield and published in 2009 aimed
to evaluate earlier reviews and literature concerning five individual surgical
procedures for male-to-female (MTF) transsexism: clitoroplasty, labiaplasty,
orchidectomy, penectomy and vaginoplasty and, eight surgical procedures for
female-to-male (FTM) transsexism: hysterectomy, mastectomy, metoidoplasty,
phalloplasty, salpingo-oophorectomy, scrotoplasty/ placement of testicular
prostheses, urethroplasty and vaginectomy was carried out. It was concluded from
this study that the evidence concerning gender reassignment surgery in both MTF
and FTM transsexism has several limitations in terms lack of controlled studies,
prospective data collection, high loss to follow up and lack of validated assessment
measures. Satisfactory outcomes were reported from some of the studies
considered, but the magnitude of benefit and harm for individual surgical procedures
cannot be estimated accurately using the current available evidence.8

A review of evidence published in 2008 to evaluate scientific validity of the recent
literature on penile reconstruction found that although, there are technical advances
in penile reconstruction however, the available long-term follow-up studies confirm
the surgical difficulty and complications limiting the final achievable outcomes. Penile
reconstruction was found to necessitate several steps and a high number of
revisions. Studies were not controlled and a high rate of loss to follow-up (especially
in sex reassignment surgery) and a lack of validated assessment measures.9

A Review of Effectiveness conducted by Aggressive Research Intelligence Facility
(ARIF)- University of Birmingham in July 2004 concluded that “the degree of
uncertainty about any of the effects of gender reassignment is such that it is
impossible to make a judgement about whether the procedure is clinically effective”.

A systematic review of evidence in 2002 commissioned by the Government of New
Zealand to determine subgroups of transsexual people who might benefit from
Gender Reassignment Surgery (GRS) showed that10 there is insufficient evidence to
support the efficacy of gender reassignment surgery for specific subgroups of
persons selected for surgical intervention. Subgroups of transsexual people who will


Date of policy: July 2009 (v 1)
Date of review: July 2011
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most likely benefit from sex reassignment surgery were not identifiable from the
evidence reviewed. Furthermore, they found that the quality of the evidence was
poor and based on a small number of studies with weak study designs and significant
methodological limitations. However, the reviewed studies may indicate that early,
rather than delayed sex reassignment surgery is of greater benefit to transsexual
people who have gone through rigorous assessment procedures and have been
accepted for surgery. Also, Gender reassignment surgery may benefit some carefully
assessed and selected transsexual people who have satisfied recognised diagnostic
and eligibility criteria, and have received recognised standards of care for surgery.

A Canadian Rapid Review of phalloplasty (penile reconstruction) in transmales found
that this remains a highly specialised procedure, requiring high levels of surgical
expertise and careful patient selection and follow-up. Limited data was available on
outcome measures, including patient selection and follow-up. Best results are to be
expected when using multidisciplinary teams of plastic surgeons, urologists,
gynecologists, and experts in sexual medicine in large volume centers.3

A few studies such as Landén et al showed only a 3.8% regret rate, indicating that
regrets are few. The study also revealed that these regrets were more likely where
there was a lack of family support.11 Poor surgical outcomes were also a factor in
some cases as shown by Smith et al. (2005) which found that no patient was actually
dissatisfied following GRS, 91.6% were satisfied with their overall appearance and
the remaining 8.4% were neutral.12


3.2 Cross- Sex Hormone Therapy
Known effects of hormone therapy in trans-women include subtle feminising effects
on appearance; slight reduction in the size of the penis and testicles; erections and
orgasm may be less readily achieved; breasts increase modestly in size;
redistribution of fat helps to achieve a more feminine appearance. There is likely to
be a loss of muscle bulk and power overtime. Some clinical experience indicates that
oestrogens also have a calming effect and augment the efficacy of, and even
replace, antidepressants over a period of time, should these have already been
prescribed. Other reported effects are arrest of male pattern baldness and facilitation
of hair removal.4


Hormone treatment in trans-men is known to promote beard and body hair growth
and also male-pattern baldness; the clitoris increases a little in size; libido may be
heightened; muscle bulk increases; the voice irreversibly deepens, and menstruation
will cease. Occasionally there may be some break-through bleeding requiring
adjustment of the dosage.4

The most serious risks associated with oestrogen usage are deep vein thrombosis
(DVT), cerebrovascular accident (CVA), pulmonary embolism (PE), altered liver
function and oestrogen-related cancers. Prolactinoma is also a theoretical risk, but in
practice is extremely rare. Trans-men on testosterone therapy may be at risk of
polycythaemia.4     Studies have indicated that in the first year of taking


Date of policy: July 2009 (v 1)
Date of review: July 2011
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ethinylestradiol (EE) the rate of development of DVT was 2.6% falling to around
0.4% per annum after that. Other types of oestrogen such as 17ß oestradiol, are
safer in this regard. Overall, short-term and medium-term usage is found to be safe;
the risks of long-term usage are unknown.4

A report of long-term experience (patients were followed lifelong) using cross–sex
hormones in the context of gender re- assignment in a hospital in Netherlands from
1995 to 2006 in over 3000 (2236 male-to-female and 876 female-to-male
transsexuals) reveals that mortality was not higher than in a comparison group.
There was a 6-8% incidence of venous thrombosis (blood clots) with ethinyl
estradiol, but not with use of other types of estrogens. Androgen deprivation plus an
estrogen in male-to-female transsexuals has a larger deleterious effect on
cardiovascular risk factors than inducing an androgenic milieu in female-to-male
transsexuals, but there is so far no elevated cardiovascular morbidity/mortality. Low
numbers of endocrine-related cancers were observed in male-to-female transsexuals.
The report concluded that cross-sex hormone treatment of transsexuals appears
acceptably safe over the short and medium term, but noted that solid clinical data
are lacking.13

3.3 Breast Augmentation (MtF)

It is estimated that up to 30-40% of MtF patients may require breast augmentation.
However, it is believed that as therapists become more skilled with HRT, this
proportion is likely to decline. Breast development is dependent on initial rate of
dosage of hormone treatment. A high initial dose could lead to the breast
development stopping at Tanner stage 3 or 4. Breast development can also depend
on the shape of the thorax (which can be very different in males to females). The
development of breast is measured on the Tanner scale, which does not measure
size, but maturity.7

The Gender Dysphoria Consortium, London suggest that breast augmentation for MtF
patients should only be considered if hormone treatment under proper
endocrinological supervision has clearly failed and, that cases would need to be
considered by the PCT on an individual basis.7

3.4 Removal of Facial Hair (MtF)

The effect of oestrogen on facial hair growth makes it less bushy and, may not
eradicate the beard. Some patients may want complete removal of facial hair to
complete a satisfactory transition. Generally, two options are available for complete
facial hair removal- electrolysis and laser treatment. The latter is faster but costs
more and only removes dark hair from light skin, not dark hair from dark skin.

According to the London Gender Dysphoria Consortium, facial hair removal could be
the most beneficial intervention for male to female patients after GRS. It has also
been recommended by the lead clinician at WLMHT.7



Date of policy: July 2009 (v 1)
Date of review: July 2011
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Removal of facial hair by laser is not always suitable and, it is believed that in many
instances, laser will not work and electrolysis will be required. Both methods take a
long time to clear the skin. Laser treatment will take up to a year to completely clear
the skin; electrolysis takes much longer than laser hair removal and both may need
to be started before referral for surgery. 7

A systematic review of RCTs to assess the efficacy and safety laser hair removal
considered 11 RCTs that met the inclusion criteria. Results from this review showed a
short term hair reduction. Approximately 50 % hair reduction was achieved with
alexandrite and diode lasers up to six months after treatment, whereas there was
little evidence for an effect with intense pulsed light neodymium. Results for long-
term effects were not recorded for any of the studies. Adverse effects were
infrequent and include pain, skin redness, swelling, burned hairs and pigmentary
changes. None of these RCTs were assessed to be of very high quality.14

With regard to facial removal (MtF), Gender Dysphoria Consortium, London,
recommends that a list of preferred providers should be developed for reasons of
quality control, performance standards, and safety.7


3.5 Rhinoplasty (Nose repair)

Rhinoplasty is an operation to change the shape of the nose. The type of rhinoplasty
depends on which particular area of the nose needs correction. Although the basic
techniques of nasal feminization surgery are not inherently different from rhinoplasty
in general, the extensive tissue reductions often required potentially put the patient
at risk of nasal valve insufficiency.15 It is one of the most technically demanding
procedures in facial plastic surgery and requires a level of sophistication derived from
diligent study, repetitive execution, and critical review.16

Evidence specifically for nasal feminisation rhinoplasty is sparse. The result of 12
patients who underwent nasal feminization as part of male-to-female gender
reassignment in a London Specialist Unit from 1998 to 2004 shows that the
procedure achieved more feminine nasal profile in all patients, although
approximately 33% (4 cases) of them needed post- operative reconstruction of the
internal nasal valve. Three nasal anthropometric measures were used as outcomes
and there were significant angular changes in two of them (the nasofrontal and
nasolabial angles but not in the Goode’s ratio). Patients were followed for a short
duration of 1 year and no instances of nasal valve insufficiency during this period.15

3.6 Lipoplasty / Body contouring (liposuction and/or body sculpture)

Lipoplasty may be considered as part of GRS to treat areas of excess fat areas of the
body including the stomach, buttocks, hips, thighs, and calves. The main methods
for lipoplasty are the traditional; laser/ultrasound and suction – assisted.

A systematic review of evidence to assess the efficacy and safety of ultrasound-
assisted lipoplasty demonstrated that the evidence base is inadequate to determine

Date of policy: July 2009 (v 1)
Date of review: July 2011
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the procedure's safety and efficacy. The potential for DNA damage the procedure
was also a source of concern.17

An RCT comparing laser- assisted and ultra-sound assisted lipoplasty found no major
clinical differences.15 It appears that both ultrasound and suction–assisted were
associated with less blood vessel damage and more specific for fat tissue aspiration.
However, higher concentrations of free fatty acids were found after laser-assisted
lipoplasty alerting to the possibility of hepatic and renal toxicity.18


4. LOCAL COST IMPLICATIONS




Epidemiological data suggests that an estimated 1 in 37,000 males and 1 in 107, 000
females in United Kingdom could have GID. Therefore, Haringey would expect to
have approximately 6 males and 2 females having Gender Identity Disorder (GID) at
any time. However, GID patients vary in the extent to which they feel dissatisfied
with their sexual identity and the extent of procedure desired, making cost difficult to
estimate and localise with certainty.

Data from SUS (PBR) revealed that 8 patients from Haringey have had 12 Gender
Identity procedures between April 2006 and December 2008.

Core procedures are funded for by the London Specialist Gender Dysphoria
Consortium and PCTs are expected to bear the cost of non- core procedures, if
approved.7



Cost of some major Non- Core procedures7

a. Breast Augmentation

It is estimated that up to 30-40% of MtF patients may require breast augmentation.
However, as therapists become more skilled with HRT, this proportion is likely to
decline.7

BUPA charge around £3,400 - £5,000 for augmentation. (CB)

Capio costs are listed as £3,800.

NHS costs = £ 4,731




Date of policy: July 2009 (v 1)
Date of review: July 2011
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b. Facial Hair removal
For facial hair removal by electrolysis, the costs and time taken vary enormously, so
it is hard to quote a reliable figure. People require between 200 and 400 hours of
treatment for permanent hair removal typically.

Costs approximately come out at around £10-£15 per hour in high street beauticians.

Therefore £12.50 x 300                                                       = £3,750


For treatment by laser, usually not more than 15 laser treatments are required. The
complete full face treatment might cost between                   £952 and £1,500

5. ELIGIBILITY



5.1 Eligibility Criteria for Funding

5.1.1 Diagnosis of transsexualism or Gender Identity Disorder for all ages

The initial diagnosis of transsexualism or Gender Identity Disorder is made by a local
GP who feels competent to undertake the assessment or by other health
professionals who have developed expertise in gender issues. Referral to a Gender
Identity Clinic should be made by an NHS Psychiatrist. The GP should refer to an
NHS psychiatrist.

5.1.2 Adults with Gender Identity Disorder

A. NHS Haringey will routinely fund Gender Dysphoria core procedures defined by
the Specialist London Consortium:

Male to Female (MtF), ‘trans women’ after having changed gender role:
          - Orchidectomy (removal of testes)
          - Penectomy (removal of the penis)
          - Vaginoplasty (creation of a vagina)
          - Clitoroplasty and labiaplasty (creation of clitoris and labia)
          - Phono-surgery (surgery on the voice –box)

Female to Male (FtM), ‘trans men’ after having changed their gender role
         - Hysterectomy (removal of uterus)
         - Vaginectomy (removal of vagina)
         - Salpingo-oophorectomy (removal of ovaries and Fallopian tubes)
         - Metoidoplasty (creation of micropenis)
         - Phalloplasty (creation of phallus)
         - Urethroplasty (creation of urethra)



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               -     Scrotoplasty (creation of scrotum) and placement of testicular
                     prosthesis
               -     Implantation of penile prosthesis
               -     Bilateral mastectomy (removal of breasts)

Cross-Gender
         - Psychotherapy
         - Hormone replacement therapy during the psychotherapeutic process
         - Speech Therapy


B. NHS Haringey will not routinely fund non- core treatments.

The following non- core procedures may be funded by the PCT where there are
exceptional circumstances and the patient meets all of the general and specific
criteria as outlined below:

- Removal of Facial Hair (MtF)
- Breast Augmentation (MtF)


5.1.3 General Criteria

 Patient is 18 years old or over;
 The patient has an initial diagnosis of transsexualism or Gender Identity Disorder
  made by a local GP who feels competent to undertake the assessment or by other
  health professionals who have developed expertise in gender issues;
 Referral to Gender Identity Clinic (GIC) is by an NHS Psychiatrist. The GP should
  refer to an NHS psychiatrist;
 The transgender identity has been present for at least two (2) years;
 The patient has clinical support from their GP to ensure future shared care;
 The disorder is not a symptom of another mental disorder or other treatable
  causes;
 Patient has undergone a successful ‘Real Life Experience’ of 3 months for
  hormonal treatment and at least 2 years for Gender Reconstruction Surgery
  (GRS);
 Patient has had at least 6 months of continuous hormonal treatment for Gender
  Reconstruction Surgery;
 Treatment is to be carried out by a multi-disciplinary team with specialised
  training and experience in gender reassignment procedures and, there is on-going
  support for the patient after the procedure;
 The decision to undergo gender reassignment is taken by a multi- disciplinary
  team including where applicable the surgeon, endocrinologist, psychiatrist;
                                                                        *
 The patient must be registered with a Haringey General Practitioner.


*
  Patient will be required to show continuity of records and evidence that real life experience had
taken place prior to submission of request for gender dysphoria procedure.

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 For GRS, patient should have continued with an established course of hormone
  reassignment therapy;
 Patients should have a demonstrable knowledge of the procedure, the required
  lengths of hospitalisations, likely complications and post-treatment rehabilitation
  and, is prepared to continue with the treatment;
 Treatment is to take place in the follow order: Hormonal treatment first followed
  by Real Life Experience and Surgery.

5.1.4 Specific Criteria

Breast Augmentation (MtF)
- Breast Development after 5 years of adequate oestrogen treatment has not
   progressed beyond Tanner stage 4 as measured by the Tanner Scale.
- Hormone treatment has been supervised by an endocrinologist over this period
   and has clearly failed.


Removal of Facial Hair (MtF)
- The recommendation for facial hair removal should be made by the
  endocrinologist, and supported by the patient’s psychiatrist.
- Appropriate drug therapy has been administered to the patient for at least a year.
- Access to therapy is for a maximum of 6 treatments only per patient.


The GIC will ensure that patients meet the eligibility criteria before commencement
of treatment for Hormone Reassignment Therapy and, prior to listing the patient for
surgery for Gender Reassignment.

The GIC will then notify the PCT in writing that the patient meets the criteria for
surgery. Patient who wish to procure all or part of their treatment privately will be
treated in accordance the Guidance on NHS patients who wish to pay for additional
private care.19

Storage of gametes to preserve reproductive potential will be in line with the existing
NHS Haringey Access to Fertility Treatments Policy.


NHS HARINGEY WILL NOT ROUTINELY PROVIDE FUNDING FOR REVERSAL
OF GENDER REASSIGNMENT SURGERY.




5.1.5 Children and Young people with Gender Identity Disorder

Where a child or young person is experiencing variance, NHS Haringey will support
such a patient and fund the following treatment if the patient is registered with a
Haringey General Practitioner:

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          -      Referral to specialist child/adolescent gender identity unit
          -      Referral to Psychiatrist
          -      Referral to endocrinologist for hormone blocking at puberty and before
                 sexual characteristics become manifest ; and
          -      Psychological support services



5.2 Exceptionality

NHS Haringey will not normally fund rhinoplasty (nose repair), reduction of other
facial bones and lipoplasty, body contouring, liposuction and/or body sculpting.
Funding applications for these procedures in exceptional cases will be considered on
individual basis by the Individual Cases Panel.

Patients who do not meet any of the above criteria for access to non-core procedures
may be considered on exceptional grounds by NHS Haringey’s Individual Cases
Panel.


6. PROCESS / NEXT STEPS


6.1 Approval & Ratification Process

-This policy was approved by the NHS Haringey Individual Cases Panel on the 6 th
July 2009.


6.2 Dissemination

The policy and eligibility for access to gender dysphoria and gender re-assignment
service will be disseminated to all GPs, secondary and tertiary care providers. It will
also be placed on NHS Haringey’s external website and Intranet.

 NHS Haringey Board will be made aware that policy exists.




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7. EXISTING GUIDELINES/POSITIONS OF PROFESSIONAL BODIES


Parliamentary Forum on Transsexualism

The Forum that includes gender specialist clinicians and trans people and form the
Parliamentary Forum on Transsexualism agreed a set of guidelines for treatments to
be commissioned for trans people.20

The Department of Health in their guidelines for General Practitioners and other
health professionals4 advise that trans people should have access to the treatments
proposed by the Parliamentary Forum. The Department of Health has produced a list
of suggested procedures for NHS organisations to commission. However, the list of
treatments is not intended to be prescriptive, and should be used flexibly in response
to the various needs and circumstances of the individual service users. The list may
also be extended in line with advances in treatment. (Appendix 3)




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8. APPENDICES


APPENDIX 17

GENDER CONSORTIUM LONDON
CURRENT CORE SURGICAL PROCEDURES

       The Core surgical procedures in the transgender genital reconstructive services
       are listed below:

Male to Female (MtF), ‘trans women’ after having changed gender role:
          - Orchidectomy (removal of testes)
          - Penectomy (removal of the penis)
          - Vaginoplasty (creation of a vagina)
          - Clitoroplasty and labiaplasty (creation of clitoris and labia)
          - Hair removal from donor site skin
          - Phonosurgery


Female to Male (FtM), ‘trans men’ after having changed their gender role
         - Hysterectomy (removal of uterus)
         - Vaginectomy (removal of vagina)
         - Salpingo-oophorectomy (removal of ovaries and Fallopian tubes)
         - Metoidoplasty (creation of micropenis)
         - Phalloplasty (creation of phallus)
         - Urethroplasty (creation of urethra)
         - Scrotoplasty (creation of scrotum) and placement of testicular
            prosthesis
         - Implantation of penile prosthesis
         - Bilateral Mastectomy
         - Hair removal from donor site skin




Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                   17
APPENDIX 2
GENDER CONSORTIUM LONDON: TREATMENT PATHWAY


                                                     Patient visits General
                                                          Practitioner


                                                        GP refers to local Consultant
                                                                Psychiatrist


                                                                Consultant refers to Gender
                                                                      Identity Clinic


                                                                     Referral checked by Admin and
                                                                     confirm PCT agreement to fund


                                                                       Referral allocated to Gender
                                                                         Consultant Psychiatrist


                                  Appointment offered


                                          1st Assessment


                                          2nd Assessment



       Follow-up appointments                                   Group session every 2nd
          every 3-4 months                                             Monday


                   Start 2-year real Life Test


                      Speech Therapy if necessary



                           Referral for surgery if
                               appropriate



                                    Surgery



                         Follow-up appointments
                        before referral back to GP




Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                                      18
APPENDIX 3
DEPARTMENT OF HEALTH: TREATMENTS THAT MAY BE COMMISSIONED

Adult with GID
In cases of adult gender dysphoria/transsexualism health commissioners may be
expected to be responsible for funding:
• support from the GP throughout the process;
• referral to a psychiatrist with specialist experience in gender dysphoria;
• ongoing assessment and psychological support when necessary. This should be
provided by a clinician with relevant specialist experience, e.g. a psychiatrist,
psychologist or psychotherapist or specialist nurse;
• within a gender identity clinic, a package that includes an image consultant,
and facilities for peer support groups (facilitated or self-led) and relatives’
support groups;
• hormone treatment including a referral to a specialist endocrinologist, or other
relevant specialist;
• referral to a specialist in reproductive medicine for advice and information
about reproductive options such as cryogenic gamete storage and mechanical
sperm retrieval and egg retrieval. Provision of storage of gametes and assisted
fertility services should be offered in accordance with existing local policy;
• providers of removal of facial hair for trans women;
• referral for chest reconstruction for trans men;
• speech and language therapy;
• thyroid chondroplasty for trans women;
• breast augmentation in trans women;
• specific gender confirmation surgery when appropriate. This would include:
– referral for hair removal from donor site;
– orchidectomy, penectomy, vaginoplasty and clitoroplasty for trans women;
and
– hysterectomy, salpingo-oophorectomy, vaginectomy, metoidioplasty,
scrotoplasty, urethroplasty and phalloplasty for trans men.
appropriate district nurse pre-operative and post-operative advice and support;
• post-operative referral to endocrinologist or other relevant specialist;
• ongoing monitoring of hormone regime (usually by a GP or, where appropriate,
an endocrinologist); and
• follow-up review by a gender specialist (at 12 months).


Commissioning treatments for young trans people

In cases of young people experiencing gender variance, their treatment services
should be well integrated with adult services. Few gender dysphoric pre-pubertal
children become gender dysphoric adults, whereas those experiencing the
condition as young people almost invariably require access to adult services.

Commissioners are responsible for funding:
• GP support and liaison;
• referral to specialist child/adolescent gender identity unit;
• referral to endocrinologist for hormone blocking during puberty; and
• psychological support services.



Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                     19
APPENDIX IV – NHS HARINGEY POLICY SETTING
Framework of Principles
Haringey TPCT’s vision is to improve the health of the local population and to ensure
that there are good quality, appropriate health services for those people that need
them. We want to ensure that people receive 21st century health services – that is
the right treatment at the right time in the right place, provided by appropriately
skilled staff.


The experience of the NHS from its inception is that demand has always outstripped
supply. There is no evidence that this is changing and thus we must sometimes
choose between providing one type of service or treatment over another. Haringey
TPCT is committed to focusing its resources where they are needed most.


Haringey TPCT will apply a number of principles, and balance these against each
other, when determining what are the most appropriate services and most
appropriate treatments for both the population of Haringey and for individuals that it
will give priority to. These principles are listed in the following sections.



1.0 Clinical Effectiveness

Our resources should be used in the most clinically effective way –
 clinical effectiveness is the extent to which specific clinical interventions, when
  deployed in the field for a particular patient or population, do what they are
  intended to do – that is, maintain or improve health, and secure the greatest
  possible health gain from available resources;
    we recognise a distinction between ‘evidence of lack of effectiveness’ and ‘lack of
     evidence of effectiveness’, and we will seek to avoid supporting the use of
     interventions for which evidence of clinical effectiveness is either absent, or too
     weak for reasonable conclusions to be reached; and
    As well as strength of evidence for a particular intervention, we will also take into
     account the likely magnitude of benefit and of safety, as well as the number of
     people who can reasonably be expected to benefit from that intervention.

2.0 Cost Effectiveness

Our resources should be used in the most cost effective way –
 the NHS is required to keep within its budget, so to maximize the care that can
  be given we must extract the maximum value from the money we spend and
  from the way in which all other types of resources are used,
    the cost of treatment is relevant because every activity has opportunity costs – if
     resources are used in one area they cannot be used in another, so we must seek



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                                                                                       20
       to use all resources in the most appropriate way if the greatest number of people
       possible are to benefit in the greatest possible ways; and
      All decisions set precedents – if one person or a group of people are given
       treatment then others in similar circumstances should receive the same
       treatment. Thus, a decision about the treatment of one person or a group of
       people can have resource implications beyond that individual or group.


3.0 Affordability

We should only provide, contract for, or commission the services that we
consider are appropriate if we have sufficient money or other resources to
do so –
     we are statutorily required to keep within the resources made available to us, that
      is, we are legally bound not to spend more money than we have been allocated;
      and
     if we spend money or use other resources on one thing, then we cannot use those
      same resources for another, so we have to recognise that even if something is
      clinically effective and it is, compared to other interventions for the same
      condition, also cost-effective, this does not necessarily mean that we will be able
      to support its use because we may not always have enough money or other
      resources available.



4.0 Equity

Our resources should be used in an equitable way –
 within the requirements of legislation and NHS regulations, and other than where
  there is good evidence that a particular characteristic (e.g. age) or lifestyle (e.g.
  smoking) adversely impacts the clinical and/or cost-effectiveness of treatment, we
                                                                                                                  †
      will seek not to directly or indirectly discriminate between people on grounds of –
               age                                                                            ‡
                                                                           place of abode
               gender                                                     employment
               ethnicity                                                  financial status
               physical, sensory or learning                              personal lifestyle
                disability


†
     This list is not exhaustive, but is intended to provide examples of the types of differences between people that
    the we will not use as grounds for determining whether one person or group of people should or should not
    receive a particular treatment, other than where there is good evidence that a characteristic is associated with
    poorer clinical or cost-effectiveness
‡
     Other than the fact that PCTs are only responsible for the health care needs of the residents of their boroughs,
    for people registered with their general medical practitioners, for the provision of a range of school nursing
    services to children attending their local schools, and for visitors to their areas who develop a need of
    emergency health care whilst there


Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                                                   21
              family or other personal                   religious beliefs
               circumstances
              sexual orientation                         social position;
   health care should be allocated justly and fairly on the basis of need, and we will
    seek to maximise the welfare of people within the resources available to us, but
    without taking a rigid approach , i.e. we will allow flexibility so that variations from
    this approach may (but will not necessarily always) be made in certain
    circumstances, such as (but not limited to) –
     urgent need, e.g. immediate life-saving treatment,
     treatment for those whose quality of life is extremely severely affected by
        disabling chronic illness,
     special characteristics of an individual patient justifying treatment of higher
        cost than normal, e.g. where an intervention may be less cost-effective for a
        particular person because of a disability or other characteristic but is otherwise
        freely available to others who do not have that disability; and
   whilst we consider that people have equal rights of access to health and health
    care services on the basis of equal need, we note that –
     there may be occasions or circumstances when some categories of care are
       given priority in order to address health inequalities in the community,
     Health and health care services should be allocated justly and fairly on the
      basis of both need and capacity to benefit, in order to maximise benefits to the
      population within the resources available. In the absence of evidence of health
      need or reasonable capacity to benefit, treatment will not generally be given
      solely because a person or a group of people request it. Similarly, a treatment
      of likely limited benefit will not necessarily be provided simply because it is the
      only treatment available;
     Sometimes the needs of the wider population conflict with the needs of
      individuals, especially when an expensive treatment may possibly produce
      some clinical benefit and possibly quite a lot of benefit, but only for a relatively
      limited time. For example, such a treatment may do something to improve a
      patient’s (or group of patients’) condition to some extent or slow the
      progression of disease but not change the ultimate outcome, i.e. it will not
      ‘cure’. However, more people may gain greater benefit if the same money or
      other resources were used for other purposes, even if that may not be in the
      best interests of an individual or smaller group of people.



5.0 Quality & Safety

The services we provide, contract for and commission should be safe and
of high quality to minimise risk to people and to minimise waste–
   high quality care can be thought of in terms of doing the right thing, in the right
    way, to the right person, at the right time and doing it right first time; and


Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                         22
   Failing to do this risks harming people and wasting limited resources (and thus
    harming other people by denying them access to services that can no longer be
    afforded).
We will therefore need to be satisfied that any service provider has adequate quality
and safety mechanisms in place. Generally, these will have to be equivalent to NHS
clinical governance mechanisms, and we will expect all standards set by the
Healthcare Commission and Care Standards Authority to be met.

6.0 Ethics

The approach that we take to determining health and health care priorities
                                                                    21
should take account of ethical considerations, specifically –
   respect for patient autonomy – which requires that we help people to make their
    own decisions (e.g. by providing important information), and respect those
    decisions (even when we may believe that a patient’s or a group of people’s
    decision may be inappropriate, noting that this does not require us to provide a
    specific treatment just because someone wants it, but only if it satisfactorily meets
    the other criteria in this framework) and only requires us to provide a treatment in
    a particular place of their choice if that meets the requirements of the national
    ‘Patient Choice’ initiative or other NHS regulations;
    we also recognise that some treatments may enable a patient to maintain their
    independence and/or dignity, e.g. prolonging the time that they can continue to
    perform everyday living activities with relative independence, and we consider that
    this is a desirable objective, although it will not necessarily take precedence over
    other considerations;
   beneficence – which emphasises the moral importance of ‘doing good’ to others,
    entailing doing what is ‘best’ for the patient or group of people (the question of
    who should be the judge of what is ‘best’ is often interpreted as focusing on what
    an objective assessment by a relevant health professional would determine as in
    the patient’s best interests, with the patient’s own views being considered through
    the principle of respect for patient autonomy, the two only conflicting when a
    competent patient chooses a course of action that might be thought of as not in
    their best interests);
   non-maleficence – which requires that we should not harm patients, and, because
    most treatments carry some risk of doing some harm as well as good, the
    potential goods and harms and their probabilities must be weighed up to decide
    what, overall, is in the patient’s or group of patients’ best interests (but it must
    also be noted that we have a duty of non-maleficence to others – we could
    indirectly harm others because a decision to provide treatment to one person or
    group of people could prevent others from receiving other care of proven clinical
    and cost-effectiveness; and
   Distributive justice – which recognises that time and resources do not allow every
    patient to have the ‘best possible’ treatment and that decisions must be made
    about which treatments can be offered within a health care system. This principle
    of justice emphasises two points:


Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                      23
     people in similar situations should normally have access to similar health care,
      and
     When determining what level of health care should be available for one group,
      we must take into account the effect of such a use of resources on others (i.e.
      the opportunity costs).



7.0 General Principles
In determining which treatment priorities to focus on, we will use mechanisms
that –
   follow technology appraisal guidelines (TAGs) from the National Institute for
                                           §
    Health and Clinical Excellence (NICE) where they exist and where the
    circumstances of patients meet NICE criteria precisely and in full;
   are based on evidence – using both local data (to enable effective targeting) and
    the results of high-quality research, including literature reviews, that are published
    in peer-reviewed publications, and including clinical guidance from national health-
    professional bodies and non-TAG clinical guidance from NICE (to enable us to
    support care that is appropriate for the largest number of people possible);
   are transparent, i.e. the reasoning behind our decisions made should be clear and
    available to anyone who wishes to see them (as long as patient confidentiality is
    preserved);
   are ethical, i.e. that meet principles of fairness and appropriateness and that seek
    to provide the greatest good for the greatest number of people whilst not
    discriminating against people who, because of their personal circumstances (e.g. a
    disability) would benefit from treatment provided in a less cost-effective way than
    were their circumstances otherwise to be similar to those of the general
    population; and
   Are managerially robust, i.e. that follow due process and can be seen to have
    done so.



8.0 Accountability
We will be accountable for our decisions, through –
   publicity – decisions and their rationale will be publicly accessible, i.e. the
    processes and the principles behind them will be ‘transparent’,
   reasonableness – our decisions and their rationale should reflect an ‘even-handed’
    and ‘sensible’ interpretation of how we should ensure both value for money and
    equitable access to the services that we provide, contract for or commission for
    the varied health needs of the population, within the resources available to us;



§
           These are also referred to as ‘final appraisal determinations (FADs)

Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                       24
   an appeal process for population-based decisions – there may be objections from
    individuals or from groups to decisions made by Commissioning Division Directors
    on recommendations made to change services and in the first instance these
    should be dealt with through the normal complaints process with a response from
    the chief executive, although it may be necessary to seek the views of the
    Commissioning Division Directors and/or the group making the recommendation
    (e.g. Individual Cases Panel) if new information or evidence is made available by
    the referring clinician;
   an appeal process for individual cases decisions – there should be a separate
    mechanism for challenge and dispute resolution, including an opportunity for us to
    change previous decisions in the light of new information or evidence, or if there is
    a prime facie case that we have failed to follow our declared process
    appropriately.
The individual cases appeal process is described in section 7 of the
Individual Cases Panel Policy.
There should be regulation of these processes by the PCT to ensure that the four
conditions above are met.




9.0 Ensuring Probity


People involved in making decisions using this framework will be bound by
the ‘Seven Principles of Public Life’ defined by the Nolan Committee. These
are:
   Selflessness – holders of public office should act solely in terms of the public
    interest. They should not do so in order to gain financial or other benefits for
    themselves, their family or their friends;
   integrity – holders of public office should not place themselves under any
    financial or other obligation to outside individuals or organisations that might seek
    to influence them in the performance of their official duties.;
   objectivity – In carrying out public business, including making public
    appointments, awarding contracts, or recommending individuals for rewards and
    benefits, holders of public office should make choices on merit.;
   accountability – holders of public office are accountable for their decisions and
    actions to the public and must submit themselves to whatever scrutiny is
    appropriate to their office;
   Openness – holders of public office should be as open as possible about all the
    decisions and actions that they take. They should give reasons for their decisions
    and restrict information only when the wider public interest clearly demands;
   honesty – holders of public office have a duty to declare any private interests
    relating to their public duties and to take steps to resolve any conflicts arising in a
    way that protects the public interest; and


Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                        25
   Leadership – holders of public office should promote and support these
    principles by leadership and example.


10.0 Developing this Framework
The principles described will be developed:
   in the light of our own experience and that of other organisations, especially to
    ensure a fair and ethical approach;
   in response to new scientific evidence coming to light concerning the effectiveness
    of health and health care interventions;
   As public values and perceptions changes; and in response to changes in
    legislation and regulatory requirements.




Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                    26
9. REFERENCES


1
 American Psychiatric Association (1994, revised 2000) Diagnostic and Statistical
Manual of Mental Disorders, 4th edition.
2
  Worcestershire Primary Care Trust. Commissioning policy and referral
Guidelines for Gender dysphoria services and Gender reassignment surgery
In adults. July 2008.
3
  Michael Sohn, Hartmut A.G. Bosinski, Gender Identity Disorders: Diagnostic and
Surgical Aspects (CME). The Journal of Sexual Health. Volume 4 Issue
5, Pages 1193 – 1208. Aug 2007.
4
 Department of Health. Guidance for GPs and other clinicians on the treatment of
gender variant people. Department of Health. May 2008.
5
  Harry Benjamin International Gender Dysphoria Association (2001) The standards
of care for gender identity disorders, sixth version. Symposion, Düsseldorf.
6
   Smith, YLS, van Goozen, SHM, Kuiper, AJ, Cohen-Kettenis, PT (2005) Sex
reassignment: outcomes and predictors of treatment for adolescent and adult
transsexuals. Psychological Medicine 35: 89–99.
7
    Gender Dysphoria Consortium, London.
8
  Sutcliffe PA, Dixon S, Akehurst RL, Wilkinson A, Shippam A, White S, Richards R,
Caddy CM. Evaluation of surgical procedures for sex reassignment: a systematic
review.J Plast Reconstr Aesthet Surg. 2009 Mar;62(3):294-306.
9
  Selvaggi G, Elander A. Penile reconstruction/formation. Curr Opin Urol. 2008
Nov;18(6):589-97
10
  Day P. Trans-gender reassignment surgery. Health Technology Assessment (HTA)
Database. July 2002.
11
   Landén, M, Walinder, Y, Hambert, G, Lundström, B (1998) Factors predictive of
regret in sex reassignment. Acta Psychiatrica Scandinavica 97(4): 284–289.
12
   Smith, YLS, Van Goozen, SHM, Kuiper, AJ, Cohen-Kettenis, PT (2005) Sex
reassignment: outcomes and predictors of treatment for adolescent and adult
transsexuals. Psychological Medicine 35: 89–99.
13
   Gooren LJ, Giltay EJ, Bunck MC.Long-term treatment of transsexuals with cross-
sex hormones: extensive personal experience. J Clin Endocrinol Metab. 2008
Jan;93(1):19-25.


Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                               27
14
     Haedersdal M, Gøtzsche PC. Laser and photoepilation for unwanted hair growth.
Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD004684. DOI:
10.1002/14651858.CD004684.pub2.
15
   S. A. Reza Nouraei, Prem Randhawa, Peter J. Andrews, Hesham A. Saleh. The Role
of Nasal Feminization Rhinoplasty in Male-to-Female Gender Reassignment. Arch
Facial Plast Surg. 2007;9(5):318-320.
16
  Williams Edwin F, LAM Samuel M. A systematic, graduated approach to rhinoplasty.
Facial plastic surgery, 2002, vol. 18, no 4 (57 p.) [Document : 8 p.] (5 ref.), pp. 215-
222 [8 page(s) (article)]
17
  Babidge W, et al. A systematic review of ultrasound-assisted lipoplasty (update
and re-appraisal. HTA database 2002.
18
   Scuderi N, Paolini G, Grippaudo F R, Tenna S. Comparative evaluation of
traditional, ultrasonic, and pneumatic assisted lipoplasty: analysis of local and
systemic effects, efficacy, and costs of these methods. NHS Economic Evaluation
Database (NHS EED). December 2003.
19
   Department of Health. Guidance on NHS patients who wish to pay for additional
private care. Department of Health. March 2009.
20
   Parliamentary Forum. Guidelines for health organisations commissioning treatment
services for trans people. Available at www.gires.org.uk/Web_Page_Assets
/frontframeset.htm.




Date of policy: July 2009 (v 1)
Date of review: July 2011
                                                                                     28

				
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