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Standards of Care for the Health of Transgender and Gender Diverse People, Version 8: References and Appendixes

Here are the References section and the Appendixes section for Standards of Care for the Health of Transgender and Gender Diverse People, Version 8.

References

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Appendixes

International Journal of Transgender Health S247
Appendix A METHODOLOGY

  1. Introduction
    This version of the Standards of Care (SOC-8) is based
    upon a more rigorous and methodological evidence-based
    approach than previous versions. This evidence is not only
    based on the published literature (direct as well as background evidence) but also on consensus-based expert opinion. Evidence-based guidelines include recommendations
    intended to optimize patient care and are informed by a
    systematic review of evidence and an assessment of the
    benefits and harms of alternative care options. Evidence-based
    research provides the basis for sound clinical practice guidelines and recommendations but must be balanced by the
    realities and feasibility of providing care in diverse settings.
    The process for development of the SOC-8 incorporated
    recommendations on clinical practice guideline development
    from the National Academies of Medicine and The World
    Health Organization that addressed transparency, the
    conflict-of-interest policy, committee composition and group
    process. (Institute of Medicine Committee on Standards for
    Developing Trustworthy Clinical Practice, 2011; World
    Health Organization, 2019a).
    The SOC-8 revision committee was multidisciplinary and
    consisted of subject matter experts, health care professionals, researchers and stakeholders with diverse perspectives
    and geographic representation. All committee members
    completed conflict of interest declarations.*
    A guideline methodologist assisted with the planning and
    development of questions, and an independent team undertook systematic reviews that were used to inform some of
    the statements for recommendations. Additional input to the
    guidelines was provided by an international advisory committee, legal experts, and feedback received during a public
    comment period. Recommendations in the SOC-8 are based
    on available evidence supporting interventions, a discussion
    of risks and harms, as well as feasibility and acceptability
    within different contexts and country settings. Consensus of
    the final recommendations was attained using a Delphi process that included all members of the Standards of Care
    Revision committee and required that recommendation statements were approved by 75% of members. Supportive and
    explanatory text of the evidence for the statements were
    written by chapter members. Drafts of the chapters were
    reviewed by the Chair and the Co-Chairs of the SOC
    Revision Committee to ensure the format was consistent,
    evidence was properly provided, and recommendations were
    consistent across chapters. An independent team checked
    the references used in the SOC-8 before the guidelines were
    fully edited by a single professional. A detailed overview of
    the SOC-8 Methodology is described below.
  2. Difference between the methodology of the
    SOC-8 and previous editions
    The main differences in the methodology of the SOC-8
    when compared with other versions of the SOC are:
  • The involvement of a larger group of professionals
    from around the globe;
  • A transparent selection process to develop the
    guidelines steering committee as well as to select
    chapter leads and members;
  • The inclusion of diverse stakeholders in the development of the SOC-8
  • Management of conflicts of interest
  • The use of a Delphi process to reach agreement on
    the recommendations among SOC-8 committee
    members
  • The involvement of an independent body from a
    reputable university to help develop the methodology and undertake independent systematic literature
    reviews where possible
  • Recommendations were graded as either “recommend” or “suggest” based upon the strength of the
    recommendations.
  • The involvement of an independent group of clinical
    academics to review citations.
  • The involvement of international organizations working with the transgender and gender diverse (TGD)
    community, members of WPATH and other professional organizations as well as the general public
    who provided feedback through a public comment
    period regarding the whole SOC-8.
  1. Overview of SOC-8 development Process
    The steps for updating the Standards of Care are summarized below:
  2. Establishing Guideline Steering Committee including
    Chair, and Co-Chairs (July 19, 2017)
  3. Determining chapters (scope of guidelines)
  4. Selecting Chapter Members based upon expertise
    (March 2018)
  5. Selecting the Evidence Review Team: John Hopkins
    University (May 2018)
  6. Refining topics included in the SOC-8 and review
    questions for systematic reviews
  7. Conducting systematic reviews (March 2019)
  8. Drafting the recommendation statements
  9. Voting on the recommendation statements using a
    Delphi process (September 2019–February 2022)
  10. Grading of the recommendations statements
  11. Writing the text supporting the statements
  12. Independently validating the references used in the
    supportive text
  13. Finalizing a draft SOC-8 (December 1, 2021)
  14. Feedback on the statements by International
    Advisory Committee
  15. Feedback on the entire draft of the SOC-8 during
    a public comment period (November 2021–January
    2022)
  16. Revision of Final Draft based on comments (January
    2022- May 2022)
  17. Approval of final Draft by Chair and Co-Chairs
    (June 10, 2022)
  18. Approval by the WPATH Board of Directors
  19. Publication of the SOC-8
  20. Dissemination and translation of the SOC-8
    S248 E. COLEMAN ET AL.
    3.1. Establishment of Guideline Steering
    Committee
    The WPATH Guideline Steering Committee oversaw the
    guideline development process for all chapters of the
    Standards of Care. Except for the Chair (Eli Coleman) who
    was appointed by the WPATH board to maintain a continuity from previous SOC editions, members of the Guideline
    Steering Committee were selected by the WPATH Board
    from WPATH members applying for these positions. Job
    descriptions were developed for the positions of Co-Chairs,
    Chapter Leads, Chapter Members and Stakeholder. WPATH
    members were eligible to apply by completing an application
    form and submitting their CV. The Board of WPATH voted for the position of co-chair (one member of the board
    did not participate in view of conflict of interest). The chairs
    and co-chairs selected the chapter leads and members (as
    well as stakeholders) based on the application form and
    CVs.
    The Guideline Steering Committee for Standards of Care
    8th Version are:
  • Eli Coleman, PhD (Chair) Professor, Director and
    Academic Chair, Institute for Sexual and Gender
    Health, Department of Family Medicine and
    Community Health, University of Minnesota Medical
    School (USA)
  • Asa Radix, MD, PhD, MPH (Co-chair) Senior
    Director, Research and Education Callen-Lorde
    Community Health Center Clinical Associate
    Professor of Medicine New York University, USA
  • Jon Arcelus, MD, PhD (Co-chair) Professor of
    Mental Health and Well-being Honorary Consultant
    in Transgender Health University of Nottingham,
    UK
  • Karen A. Robinson, PhD (Lead, Evidence Review
    Team) Professor of Medicine, Epidemiology and
    Health Policy & Management Johns Hopkins
    University, USA
    3.2. Determination of topics for chapters
    The Guideline Steering Committee determined the chapters
    for inclusion in the Standards of Care by reviewing the
    literature and by reviewing the previous edition of the SOC.
    The chapters in the Standards of Care 8th Version:
  1. Terminology
  2. Global Applicability
  3. Population estimates
  4. Education*
  5. Assessment of Adults
  6. Adolescent
  7. Children
  8. Nonbinary
  9. Eunuch
  10. Intersex
  11. Institutional environments
  12. Hormone Therapy
  13. Surgery and Postoperative Care
  14. Voice and communication
  15. Primary care
  16. Reproductive Health
  17. Sexual Health
  18. Mental Health
  • The Education Chapter was originally intended to cover both education and ethics. A decision was made to create a separate committee to write a chapter on ethics. In
    the course of writing the chapter, it was later determined
    topic of ethics was best placed external to the SOC8 and
    required further in-depth examination of ethical considerations relevant to transgender health.
    3.3. Selection of chapter members
    A call for applications to be part of the SOC-8 review
    committee (chapter lead or member) was sent to the
    WPATH membership. The Chairs of the Guideline Steering
    Committee appointed the members for each chapter, ensuring representation from a variety of disciplines and perspectives.
    Chapter Leads and Members were required to be
    WPATH Full Members in good standing and content experts in transgender health, including in at least one chapter topic. Chapter Leads reported to the Guideline Steering
    Committee and were responsible for coordinating the participation of Chapter Members. Chapter members reported
    directly to the Chapter Lead.
    Each chapter also included stakeholders as members who
    bring perspectives of transgender health advocacy or work
    in the community, or as a member of a family that included a transgender child, sibling, partner, parent, etc.
    Stakeholders were not required to be full members of
    WPATH.
    The Chapter Members were expected to:
  • Participate in the development refinement of review
    questions
  • Read and provide comments on all materials from
    the Evidence Review Team
  • Critically review draft documents, including the
    draft evidence report
  • Review and assess evidence and draft
    recommendations
  • Participate in the Delphi consensus process
  • Develop the text to back up the recommendation
    statements
  • Grade each statement to describe the strength of
    the recommendation
  • Review and address the comments from the Chairs
    during the whole process
  • Develop the content of the chapters
  • Review comments from public comments and assist
    in the development of a revision of guidelines
  • Provide input and participate in the dissemination
    of guidelines
    Training and orientation for Chapter Leads and Members
    was provided, as needed. Training content included formulation and refinement of questions (i.e., use of PICO), reviewing the evidence, developing recommendation state-
    International Journal of Transgender Health S249
    ments, grading the evidence and the recommendations, and
    information about the guideline development program and
    process.
    A total of 26 chapter-leads were appointed (some chapters required co-leads), 77 chapter members and 16 stakeholders. A total of 127 were selected. During the SOC
    process, 8 people left, due to personal or work-related issues. Therefore, there were 119 final authors of the SOC-8.
    3.4. Selection of the evidence review team
    The WPATH Board issued a request for applications to
    become the Evidence Review Team. For Standards of Care
    8th Version the WPATH Board engaged the Evidence
    Review Team at Johns Hopkins University under the leadership of Karen Robinson.
  • Karen A. Robinson, PhD (Lead, Evidence Review
    Team) Professor of Medicine, Epidemiology and
    Health Policy & Management Johns Hopkins
    University, USA
    Dr Robinson also guided the steering committee in the
    development of the SOC-8 by providing advice and training
    in the development of PICO questions, statements, and the
    Delphi process as well as undertaking a very rigorous systematic literature review where direct evidence was available.
    Conflict of interest
    Members of the Guideline Steering Committee, Chapter
    Leads and Members, and members of the Evidence Review
    Team were asked to disclose any conflicts of interest. Also
    reported, in addition to potential financial and competing
    interests or conflicts, are personal or direct reporting relationships with a chair, co-chair or a WPATH Board Member
    or the holding of a position on the WPATH Board of
    Directors.
    3.5. Refinement of topics and review of questions
    The Evidence Review Team abstracted the recommendation
    statements from the prior version of the Standards of Care.
    With input from the Evidence Review Team, the Guideline
    Steering Committee and Chapter Leads determined:
  • Recommendation statements that needed to be
    updated
  • New areas requiring recommendation statements
    3.6. Conduct the systematic reviews
    Chapter Members developed questions to help develop recommendation statements. For the questions eligible for
    systematic review, the Evidence Review Team drafted review
    questions, specifying the Population, Interventions,
    Comparisons, and Outcomes (PICO elements). The Evidence
    Review Team undertook the systematic reviews. The
    Evidence Review Team presented evidence tables and other
    results of the systematic reviews to the members of the
    relevant chapter for feedback.
    Protocol
    A separate detailed systematic review protocol was developed for each review question or topic, as appropriate. Each
    protocol was registered on PROSPERO.
    Literature search
    The Evidence Review Team developed a search strategy
    appropriate for each research question including MEDLINE®,
    Embase™, and the Cochrane Central Register of Controlled
    Trials (CENTRAL). The Evidence Review Team searched
    additional databases as deemed appropriate for the research
    question. The search strategy included MeSH and text terms
    and was not limited by language of publication or date.
    The Evidence Review Team hand searched the reference
    lists of all included articles and recent, relevant systematic
    reviews. The Evidence Review Team searched ClinicalTrials.
    gov for any additional relevant studies.
    Searches were updated during the peer review process.
    The literature included in the systematic review was
    mostly based on quantitative studies conducted in Europe,
    the US or Australia. We acknowledge a bias towards perspectives from the global north that does not pay sufficient
    attention to the diversity of lived experiences and perspectives within transgender and gender diverse (TGD) communities across the world. This imbalance of visibility in
    the literature points to a research and practice gap that
    needs to be addressed by researchers and practitioners in
    the future in order to do justice to the support needs of
    all TGD people independent of gender identification.
    Study selection
    The Evidence Review Team, with input from the Chapter
    Workgroup Leads, defined the eligibility criteria for each
    research question a priori.
    Two reviewers from the Evidence Review Team independently screened titles and abstracts and full-text articles
    for eligibility. To be excluded, both reviewers needed to
    agree that the study met at least one exclusion criteria.
    Reviewers resolved differences regarding eligibility through
    discussion.
    Data extraction
    The Evidence Review Team used standardized forms to
    abstract data on general study characteristics, participant
    characteristics, interventions, and outcome measures. One
    reviewer abstracted the data, and a second reviewer confirmed the abstracted data.
    Assessment of risk of bias
    Two reviewers from the Evidence Review Team independently assessed the risk of bias for each included study. For
    S250 E. COLEMAN ET AL.
    randomized controlled trials, the Cochrane Risk of Bias Tool
    was used. For observational studies, the Risk of Bias in
    Non-Randomized Studies—of Interventions (ROBINS-I) tool
    was used. Where deemed appropriate, existing recent systematic reviews were considered and evaluated using ROBIS.
    Data synthesis and analysis
    The Evidence Review Team created evidence tables detailing
    the data abstracted from the included studies. The members
    of the Chapter Workgroups reviewed and provided comments on the evidence tables.
    Grading of the evidence
    The Evidence Review Team assigned evidence grades using
    the GRADE methodology. The strength of the evidence was
    obtained using predefined critical outcomes for each question and by assessing the limitations to individual study
    quality/risk of bias, consistency, directness, precision, and
    reporting bias.
    3.7. Drafting of the Recommendation Statements
    Chapter Leads and Members drafted recommendation statements. The statements were crafted to be feasible, actionable,
    and measurable.
    Evidence-based recommendation statements were based
    on the results of the systematic, and background literature
    reviews plus consensus-based expert opinions.
    The Chair and Co-Chairs and Chapter Leads reviewed
    and approved all recommendation statements for clarity
    and consistency in wording. During this review and
    throughout the process any overlap between chapters was
    also addressed.
    Many chapters had to work closely together to ensure
    consistency of their recommendations. For example, as there
    are now separate chapters for childhood and adolescence, to
    ensure consistency between both chapters, some authors were
    part of both chapters. For a similar reason, when applicable,
    a workgroup collaborated with other Chapter Workgroups
    on topics shared between the chapters (i.e., Assessment of
    Children, Assessment of Adults, Hormone Therapy, Surgery
    and Postoperative Care and Reproductive Health).
    3.8. Approval of the recommendations using the
    Delphi process
    Formal consensus for all statements was obtained using the
    Delphi process (a structured solicitation of expert judgements in three rounds). For a recommendation to be approved, a minimum of 75% of the voters had to approve
    the statement. A minimum of 65% of the SOC-8 members
    had to take part in the Delphi process for each statement.
    People who did not approve the statement had to provide
    information as to the reasons for their disapproval, so the
    statement could be modified (or removed) according to this
    feedback. Once modified, the statement was put through
    the Delphi process again. If after 3 rounds the statement
    was not approved, the statement was removed from the
    SOC. Every member of the SOC voted for each statement.
    There was a response rate between (74.79% and 94.96%)
    for the statements.
    3.9. Grading criteria for statements
    Once the statements passed the Delphi process, chapter
    members graded each statement using a process adapted
    from the Grading of Recommendations, Assessment,
    Development and Evaluations (GRADE) framework. This a
    transparent framework for developing and presenting summaries of evidence and provides a systematic approach for
    making clinical practice recommendations (Guyatt et al.,
    2011). The statements were graded based on factors such as:
  • The balance of potential benefits and harms
  • Confidence in that balance or quality of evidence
  • Values and preferences of providers and patients
  • Resource use and feasibility
    The statements were classified as:
  • Strong recommendations (“we recommend”) are for
    those interventions/therapy/strategies where:
  • the evidence is of high quality
  • estimates of the effect of an intervention/therapy/
    strategy (i.e., there is a high degree of certainty
    effects will be achieved in practice)
  • there are few downsides of therapy/intervention/
    strategy
  • there is a high degree of acceptance among providers and patients or those for whom the recommendation applies.
  • Weak recommendations (“we suggest”) are for those
    interventions/therapy/strategies where:
  • there are weaknesses in the evidence base
  • there is a degree of doubt about the size of the
    effect that can be expected in practice
  • there is a need to balance the potential upsides and
    downsides of interventions/therapy/strategies
  • there are likely to be varying degrees of acceptance among providers and patients or those for
    whom the recommendation applies.
    3.10. Writing of the text supporting the
    statements
    Following the grading of the statements, the Chapter
    Workgroups wrote the text providing the rationale or reasoning for the recommendation. This included providing
    the available evidence, providing details about potential
    benefits and harms, describing uncertainties, and information about implementation of the recommendation,
    including expected barriers or challenges among others.
    References use APA-7 style, to support the information
    in the text. Links to resources are also provided, as appropriate. The text, including whether a recommendation
    has been described as strong or weak, was reviewed and
    approved by the Chair and Co-Chairs.
    International Journal of Transgender Health S251
    3.11. External validation of references used to
    support the statements
    A group of independent clinical academics working in the
    field of transgender health reviewed the references used
    in every chapter in order to validate that the references
    were appropriately used to support the text. Any queries
    regarding the references were sent back to the chapters
    for review.
    3.12. Finalizing a draft SOC-8
    A final SOC-8 draft was made available for comments.
    3.13. Distribute Standards of Care for review by
    international advisors
    The statements of the recommendations of Standards of
    Care 8th were circulated among the broader Standards of
    Care Revision Committee and the WPATH International
    Advisory Group, which included the Asia Pacific Transgender
    Network (APTN), the Global Action for Transgender
    Equality (GATE), the International Lesbian, Gay, Bisexual,
    Transgender, Intersex Association (ILGA), and Transgender
    Europe (TGEU).
    3.14. Public comment period
    The revised draft version of the Standards of Care document was posted online for comment from the public,
    including WPATH members, on the WPATH website. A
    6-week period was allocated for comments. A total of 1,279
    people made comments on the draft with a total of 2,688
    comments.
    3.15. Revision of final draft based on comments
    The Chapter Leads and Guideline Steering Committee considered the feedback and made any necessary revisions. All
    public comments were read and, where appropriate, integrated into the background text.
    As part of this process, 3 new Delphi statements were
    developed and 2 were modified enough to require a new
    vote by the SOC-8 committee. This meant a new Delphi
    process was initiated in January 2022. The results of this
    Delphi process were accepted by the chapters, and the new
    statements were added or modified accordingly. The new
    supportive text was added.
    All the new versions of the chapters were reviewed again
    by the Chair and Co-Chairs and changes or modifications
    were suggested. Finally, once the Chairs and the Chapter
    Members were satisfied with the draft, the chapter was
    finalized.
    All new references were double checked by an independent member.
    3.16. Approval of final draft by Chair and
    Co-Chairs
    Modifications were reviewed by the Chairs and were accepted by them.
    3.17. Approval by the WPATH Board of Directors
    The final document was presented to the WPATH Board
    of Directors for approval and it was approved on the 20th
    of June 2022.
    3.18. Publication of the SOC-8 and dissemination
    of the Standards of Care
    The Standards of Care was disseminated in a number of
    venues and in a number of formats including publication
    in the International Journal of Transgender Health (the
    official scientific journal of WPATH).

Plan to Update
A new edition of the SOC (SOC-9) will be developed in
the future, when new evidence and/or significant changes
in the field necessitating a new edition is substantial.
*The development of SOC-8 was a complex process at
a time of COVID-19 and political uncertainties in many
parts of the world. Members of the SOC-8 worked on the
SOC-8 on top of their day-to-day job, and most of the
meetings took place out of their working time and during
their weekends via Zoom. There were very few face-to-face
meetings, most of them linked to WPATH, USPATH or
EPATH conferences. Committee members of the SOC-8
were not paid as part of this process.
S252 E. COLEMAN ET AL.
Appendix B GLOSSARY
CISGENDER refers to people whose current gender identity corresponds to the sex they were assigned at birth.
DETRANSITION is a term sometimes used to describe an
individual’s retransition to the gender stereotypically associated with their sex assigned at birth.
EUNUCH refers to an individual assigned male at birth
whose testicles have been surgically removed or rendered
non-functional and who identifies as a eunuch. This differs
from the standard medical definition by excluding those
who do not identify as eunuch.
EUNUCH-IDENTIFIED: An individual who feels their
true self is best expressed by the term eunuch.
Eunuch-identified individuals generally desire to have their
reproductive organs surgically removed or rendered
non-functional.
GENDER: Depending on the context, gender may reference
gender identity, gender expression, and/or social gender
role, including understandings and expectations culturally
tied to people who were assigned male or female at birth.
Gender identities other than those of men and women (who
can be either cisgender or transgender) include transgender,
nonbinary, genderqueer, gender neutral, agender, gender
fluid, and “third” gender, among others; many other genders
are recognized around the world.
GENDER-AFFIRMATION refers to being recognized or
affirmed in a person’s gender identity. It is usually conceptualized as having social, psychological, medical, and
legal dimensions. Gender affirmation is used as a term
in lieu of transition (as in medical gender-affirmation) or
can be used as an adjective (as in gender-affirming care).
GENDER-AFFIRMATION SURGERY (GAS) is used to
describe surgery to change primary and/or secondary sex
characteristics to affirm a person’s gender identity.
GENDER BINARY refers to the idea there are two and
only two genders, men and women; the expectation that
everyone must be one or the other; and that all men are
males, and all women are females.
GENDER DIVERSE is a term used to describe people with
gender identities and/or expressions that are different from
social and cultural expectations attributed to their sex assigned at birth. This may include, among many other culturally diverse identities, people who identify as nonbinary,
gender expansive, gender nonconforming, and others who
do not identify as cisgender.
GENDER DYSPHORIA describes a state of distress or
discomfort that may be experienced because a person’s gender identity differs from that which is physically and/or
socially attributed to their sex assigned at birth. Gender
Dysphoria is also a diagnostic term in the DSM-5 denoting
an incongruence between the sex assigned at birth and
experienced gender accompanied by distress. Not all transgender and gender diverse people experience gender dysphoria.
GENDER EXPANSIVE is an adjective often used to describe people who identify or express themselves in ways
that broaden the socially and culturally defined behaviors
or beliefs associated with a particular sex. Gender creative
is also sometimes used. The term gender variant was used
in the past and is disappearing from professional usage
because of negative connotations now associated with it.
GENDER EXPRESSION refers to how a person enacts or
expresses their gender in everyday life and within the context of their culture and society. Expression of gender
through physical appearance may include dress, hairstyle,
accessories, cosmetics, hormonal and surgical interventions
as well as mannerisms, speech, behavioral patterns, and
names. A person’s gender expression may or may not conform to a person’s gender identity.
GENDER IDENTITY refers to a person’s deeply felt, internal, intrinsic sense of their own gender.
GENDER INCONGRUENCE is a diagnostic term used in
the ICD-11 that describes a person’s marked and persistent
experience of an incompatibility between that person’s gender identity and the gender expected of them based on
their birth-assigned sex.
INTERSEX refers to people born with sex or reproductive
characteristics that do not fit binary definitions of female
or male.
MISGENDER/MISGENDERING refers to when language
is used that does not correctly reflect the gender with which
a person identifies. This may be a pronoun (he/him/his,
she/her/hers, they/them/theirs) or a form of address (sir,
Mr.).
NONBINARY refers to those with gender identities outside
the gender binary. People with nonbinary gender identities
may identify as partially a man and partially a woman or
identify as sometimes a man and sometimes a woman, or
identify as a gender other than a man or a woman, or as
not having a gender at all. Nonbinary people may use the
pronouns they/them/theirs instead of he/him/his or she/
her/hers. Some nonbinary people consider themselves to be
transgender or trans; some do not because they consider
transgender to be part of the gender binary. The shorthand
NB or “enby” is sometimes used as a descriptor for nonbinary. Examples of nonbinary gender identities are genderqueer, gender diverse, genderfluid, demigender, bigender,
and agender.
RETRANSITION refers to second or subsequent gender
transition whether by social, medical, or legal means. A
retransition may be from one binary or nonbinary gender
to another binary or nonbinary gender. People may retransition more than once. Retransition may occur for many
reasons, including evolving gender identities, health concerns, family/societal concerns, and financial issues.
SEX ASSIGNED AT BIRTH refers to a person’s status as
male, female, or intersex based on physical characteristics.
Sex is usually assigned at birth based on appearance of the
external genitalia. AFAB is an abbreviation for “assigned
female at birth.” AMAB is an abbreviation for “assigned
male at birth.”
SEXUAL ORIENTATION refers to a person’s sexual identity, attractions, and behaviors in relation to people on the
basis of their gender(s) and or sex characteristics and those
of their partners. Sexual orientation and gender identity
are distinct terms.
TRANSGENDER or trans are umbrella terms used to describe people whose gender identities and/or gender expressions are not what is typically expected for the sex to
which they were assigned at birth. These words should
always be used as adjectives (as in “trans people”) and
never as nouns (as in “transgenders”) and never as verbs
(as in “transgendered”).
International Journal of Transgender Health S253
TRANSGENDER MEN or TRANS MEN or MEN OF
TRANS EXPERIENCE are people who have gender identities as men and who were assigned female at birth. They
may or may not have undergone any transition. FTM or
Female-to-Male are older terms that are falling out of use.
TRANSGENDER WOMEN or TRANS WOMEN or
WOMEN OF TRANS EXPERIENCE are people who have
gender identities as women and who were assigned male
at birth. They may or may not have undergone any transition. MTF or Male-to-Female are older terms that are
falling out of use.
TRANSITION refers to the process whereby people usually change from the gender expression associated with their
assigned sex at birth to another gender expression that
better matches their gender identity. People may transition
socially by using methods such as changing their name,
pronoun, clothing, hair styles, and/or the ways that they
move and speak. Transitioning may or may not involve
hormones and/or surgeries to alter the physical body.
Transition can be used to describe the process of changing
one’s gender expression from any gender to a different gender. People may transition more than once in their lifetimes.
TRANSPHOBIA refers to negative attitudes, beliefs, and
actions concerning transgender and gender diverse people
as a group. Transphobia may be enacted in discriminatory policies and practices on a structural level or in very
specific and personal ways. Transphobia can also be internalized, when transgender and gender diverse people
accept and reflect such prejudice about themselves or
other transgender and gender diverse people. While transphobia sometimes may be a result of unintentional ignorance rather than direct hostility, its effects are never
benign. Some people use the term anti-transgender bias
in place of transphobia.
S254 E. COLEMAN ET AL.
Appendix C GENDER-AFFIRMING HORMONAL
TREATMENT

Table 1. Expected time course of physical changes in
response to gender-affirming hormone therapy
Testosterone Based Regimen
Effect Onset Maximum
Skin Oiliness/acne 1–6 months 1–2 years
Facial/body hair growth 6–12 months >5 years
Scalp hair loss 6–12 months >5 years
Increased muscle mass/
strength
6–12 months 2–5 years
Fat redistribution 1–6 months 2–5 years
Cessation of menses 1–6 months 1–2 years
Clitoral enlargement 1–6 months 1–2 years
Vaginal atrophy 1–6 months 1–2 years
Deepening of voice 1–6 months 1–2 years
Estrogen and testosterone-lowering based regimens
Effect Onset Maximum
Redistribution of body fat 3–6 months 2–5 years
Decrease in muscle mass
and strength
3–6 months 1–2 years
Softening of skin/
decreased oiliness
3–6 months Unknown
Decreased sexual desire 1–3 months Unknown
Decreased spontaneous
erections
1–3 months 3–6 months
Decreased sperm
production
Unknown 2 years
Breast growth 3–6 months 2–5 years
Decreased testicular
volume
3–6 months Variable
Decreased terminal hair
growth
6–12 months > 3 years
Increased scalp hair Variable Variable
Voice changes None
Adapted from Hembree et al., 2017.

Table 2. Risks associated with gender affirming hormone
therapy (bolded items are clinically significant) (Updated
from SOC-7)
RISK LEVEL Estrogen-based regimens
Testosterone-based
regimens
Likely increased
risk
Venous
Thromboembolism
Infertility
Hyperkalemias
Hypertrigyceridemia
Weight Gain
Polycythemia
Infertility
Acne
Androgenic Alopecia
Hypertension
Sleep Apnea
Weight Gain
Decreased HDL Cholesterol
and increased LDL
Cholesterol
Likely increased
risk with
presence of
additional
risk factors
Cardiovascular Disease
Cerebrovascular Disease
Meningiomac
Polyuria/Dehydrations
Cholelithiasis
Cardiovascular Disease
Hypertriglyceridemia
Possible
increased risk
Hypertension
Erectile Dysfunction
Possible
increased
risk with
presence of
additional
risk factors
Type 2 Diabetes
Low Bone Mass/
Osteoporosis
Hyperprolactinemia
Type 2 Diabetes
Cardiovascular Disease
No increased
risk or
inconclusive
Breast and Prostate
Cancer
Low Bone Mass/
Osteoporosis
Breast, Cervical, Ovarian,
Uterine Cancer
Ccyproterone-based regimen
S
spironolactone-based regimen

Table 3. Gender-Affirming Hormone Regimens In Transgender
And Gender Diverse Youth (Adapted from the Endocrine Society
Guidelines; Hembree et al., 2017)
Induction of female puberty (estrogen-based regimen) with oral
17ß-estradiol
Initiate at 5µg/kg/d and increase every 6 months by 5 µg/kg/d up to
20 µg/kg/d according to estradiol levels
Adult dose = 2-6mg/day
In postpubertal TGD adolescents, the dose of 17ß-estradiol can be
increased more rapidly:
1mg/d for 6 months followed by 2mg/d and up according to estradiol
levels
Induction of female puberty (estrogen-based regimen) with
transdermal 17ß-estradiol
Initial dose 6.25-12.5 µg/24 h (cutting 24 g patch to ¼ then ½)
Titrate up by every 6 months by 12.5 µg/24 h according to estradiol
levels
Adult dose = 50-200 µg/24 hours
For alternatives once at adult dose (Table 4)
Induction of male puberty (testosterone-based regimen) with
testosterone esters
25mg/m2
/2 weeks (or alternatively half this dose weekly)
Increase by 25mg/m2
/2 weeks every 6 months until adult dose and
target testosterone levels are achieved. See alternatives for
testosterones (Table 4)
Table 4. Hormone regimens in transgender and gender
diverse adults*
Estrogen-based regimen (Transfeminine)
 Estrogen
  Oral or sublingual
   Estradiol 2.0-6.0mg/day
  Transdermal
   Estradiol transdermal patch 0.025-0.2mg/day
   Estradiol gel various ‡ daily to skin
Parenteral
   Estradiol valerate or cypionate 5-30mg IM every 2 weeks
2-10 IM every week
 Anti-Androgens
  Spironolactone 100–300mg/day
Cyproterone acetate 10mg/day**
  GnRH agonist 3.75–7.50mg SQ/IM monthly
  GnRH agonist depot formulation 11.25/22.5mg SQ/IM 3/6
monthly
‡ Amount applied varies to formulation and strength
Testosterone-Based Regimen (Transmasculine)
Transgender males
 Testosterone
Parenteral
   Testosterone enanthate/
cypionate
50–100 IM/SQ weekly or
100–200 IM every 2 weeks
   Testosterone undecanoate 1000mg IM every 12 weeks or
750mg IM every 10 weeks
   Transdermal testosterone
   Testosterone gel 50-100mg/day
   Testosterone transdermal patch 2.5–7.5mg/day
*
Doses are titrated up or down until sex steroid hormone levels are in
the therapeutic range. Hormone regimens do not reflect all formulations that are available in all pharmacies throughout the world.
Hormone regimens may have to be adapted to what is available in
local pharmacies.
**Kuijpers et al (2021).

Table 5. Hormone monitoring of transgender and gender diverse people receiving gender-affirming hormone therapy (Adapted from the Endocrine Society Guidelines) Transgender male or trans masculine (including gender diverse/nonbinary) individuals 1. Evaluate patient approximately every 3 months (with dose changes) in the first year and 1 to 2 times per year thereafter to monitor for appropriate physical changes in response to testosterone. 2. Measure serum total testosterone every 3 months (with dose changes) until levels are at goal a. For parenteral testosterone, the serum total testosterone should be measured midway between injections. The target level is 400-700 ng/dL. Alternatively, measure peak and trough peaks to ensure levels remain in the range of reference men. b. For parenteral testosterone undecanoate, testosterone should be measured just before injection. If the level is < 400ng/dL, adjust the dosing interval. c. For transdermal testosterone, the testosterone level can be measured no sooner than after 1 week of daily application (at least 2hours after application of product). 3. Measure hematocrit or hemoglobin concentrations at baseline and approximately 3 months (with dose changes) for the first year and then one to two times a year. Transgender Female or trans feminine (including gender diverse/nonbinary) individuals 1. Evaluate patient approximately every 3 months (with dose changes) in the first year and one to two times per year thereafter to monitor for appropriate physical changes in response to estrogen. a. Serum testosterone levels should be less than 50 ng/dL. b. Serum estradiol should be in the range of 100-200 pg/mL. 2. For individuals receiving spironolactone, serum electrolytes, in particular potassium, and kidney function, in particular creatinine, should be monitored. 3. Follow primary care screening per primary care chapter recommendations

S256 E. COLEMAN ET AL.
Appendix D SUMMARY CRITERIA FOR
HORMONAL AND SURGICAL TREATMENTS FOR
ADULTS AND ADOLESCENTS
The SOC-8 guidelines are intended to be flexible in order
to meet the diverse health care needs of TGD people globally. While adaptable, they offer consensus-based standards
derived from the best available scientific evidence for promoting optimal health care and guiding the treatment of
people experiencing gender incongruence. As in all previous
versions of the SOC, the criteria put forth in this document
for gender affirming interventions are clinical guidelines;
individual health care professionals and programs, in consultation with the TGD person, may modify them. Clinical
departures from the SOC may occur due to a TGD person’s
unique anatomic, social, or psychological situation; an experienced health care professional’s evolving method of
handling a common situation; a research protocol; lack of
resources in various parts of the world; or the need for
specific harm-reduction strategies. These departures should
be recognized as such, discussed with the TGD person, and
documented. This documentation is also valuable for the
accumulation of new data, which can be retrospectively
examined to allow for health care—and the SOC—to evolve.
This summary criteria needs to be read in conjunction with
the relevant chapters (see Adult Assessment and Adolescent
chapters).
SUMMARY CRITERIA FOR ADULTS
Related to the assessment process

Health care professionals assessing transgender and
gender diverse adults seeking gender-affirming treatment should liaise with professionals from different
disciplines within the field of trans health for consultation and referral, if required*

If written documentation or a letter is required to
recommend gender affirming medical and surgical
treatment (GAMST), only one letter of assessment
from a health care professional who has competencies in the assessment of transgender and gender
diverse people is needed.
Criteria for hormones
a. Gender incongruence is marked and sustained;
b. Meets diagnostic criteria for gender incongruence
prior to gender-affirming hormone treatment in
regions where a diagnosis is necessary to access
health care;
c. Demonstrates capacity to consent for the specific
gender-affirming hormone treatment;
d. Other possible causes of apparent gender incongruence have been identified and excluded;
e. Mental health and physical conditions that could
negatively impact the outcome of treatment have
been assessed, with risks and benefits discussed;
f. Understands the effect of gender-affirming hormone treatment on reproduction and they have
explored reproductive options.
Criteria for surgery
a. Gender incongruence is marked and sustained;
b. Meets diagnostic criteria for gender incongruence prior
to gender-affirming surgical intervention in regions
where a diagnosis is necessary to access health care;
c. Demonstrates capacity to consent for the specific
gender-affirming surgical intervention;
d. Understands the effect of gender-affirming surgical
intervention on reproduction and they have
explored reproductive options;
e. Other possible causes of apparent gender incongruence have been identified and excluded;
f. Mental health and physical conditions that could
negatively impact the outcome of gender-affirming
surgical intervention have been assessed, with risks
and benefits have been discussed;
g. Stable on their gender affirming hormonal treatment regime (which may include at least 6 months
of hormone treatment or a longer period if
required to achieve the desired surgical result,
unless hormone therapy is either not desired or
is medically contraindicated).*
*These were graded as suggested criteria
SUMMARY CRITERIA FOR ADOLESCENTS
Related to the assessment process

A comprehensive biopsychosocial assessment including
relevant mental health and medical professionals;

Involvement of parent(s)/guardian(s) in the assessment process, unless their involvement is determined
to be harmful to the adolescent or not feasible;

If written documentation or a letter is required to
recommend gender-affirming medical and surgical
treatment (GAMST), only one letter of assessment
from a member of the multidisciplinary team is
needed. This letter needs to reflect the assessment
and opinion from the team that involves both medical and mental health professionals (MHPs).
Puberty blocking agents
a. Gender diversity/incongruence is marked and sustained over time;
b. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary
to access health care;
c. Demonstrates the emotional and cognitive maturity
required to provide informed consent/assent for
the treatment;
d. Mental health concerns (if any) that may interfere
with diagnostic clarity, capacity to consent, and
gender-affirming medical treatments have been
addressed; sufficiently so that gender-affirming
medical treatment can be provided optimally.
e. Informed of the reproductive effects, including the
potential loss of fertility and the available options
to preserve fertility;
f. Reached Tanner stage 2.
International Journal of Transgender Health S257
Hormonal treatments
a. Gender diversity/incongruence is marked and sustained over time;
b. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary
to access health care;
c. Demonstrates the emotional and cognitive maturity
required to provide informed consent/assent for
the treatment;
d. Mental health concerns (if any) that may interfere
with diagnostic clarity, capacity to consent, and
gender-affirming medical treatments have been
addressed; sufficiently so that gender-affirming
medical treatment can be provided optimally.
e. Informed of the reproductive effects, including the
potential loss of fertility and the available options
to preserve fertility;
f. Reached Tanner stage 2.
Surgery
a. Gender diversity/incongruence is marked and
sustained over time;
b. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary
to access health care;
c. Demonstrates the emotional and cognitive maturity
required to provide informed consent/assent for
the treatment;
d. Mental health concerns (if any) that may interfere
with diagnostic clarity, capacity to consent, and
gender-affirming medical treatments have been
addressed; sufficiently so that gender-affirming
medical treatment can be provided optimally.
e. Informed of the reproductive effects, including the
potential loss of fertility and the available options
to preserve fertility;
f. At least 12 months of gender-affirming hormone
therapy or longer, if required, to achieve the
desired surgical result for gender-affirming procedures, including breast augmentation, orchiectomy, vaginoplasty, hysterectomy, phalloplasty,
metoidioplasty, and facial surgery as part of
gender-affirming treatment unless hormone therapy is either not desired or is medically
contraindicated.

S258 E. COLEMAN ET AL.
Appendix E GENDER-AFFIRMING SURGICAL
PROCEDURES
As the field’s understanding of the many facets of gender
incongruence expands, and as technology develops which
allows for additional treatments, it is imperative to understand this list is not intended to be exhaustive. This is particularly important given the often lengthy time periods
between updates to the SOC, during which evolutions in
understanding and treatment modalities may occur.

FACIAL SURGERY
Brow • Brow reduction

Brow augmentation

Brow lift
Hair line advancement and/or hair transplant
Facelift/mid-face lift (following alteration of the underlying skeletal
structures)
Facelift/mid-face lift (following alteration of the underlying skeletal
structures)

Platysmaplasty
Blepharoplasty • Lipofilling
Rhinoplasty (+/- fillers)
Cheek • Implant

Lipofilling
Lip • Upper lip shortening

Lip augmentation (includes autologous and non-autologous)
Lower jaw • Reduction of mandibular angle

Augmentation
Chin reshaping • Osteoplastic

Alloplastic (implant-based)
Chondrolaryngoplasty • Vocal cord surgery (see voice chapter)
BREAST/CHEST SURGERY
Mastectomy • Mastectomy with nipple-areola preservation/reconstruction as determined
medically necessary for the specific patient

Mastectomy without nipple-areola preservation/reconstruction as
determined medically necessary for the specific patient
Liposuction
Breast reconstruction (augmentation) • Implant and/or tissue expander

Autologous (includes flap-based and lipofilling)
GENITAL SURGERY
Phalloplasty (with/without scrotoplasty) • With/without urethral lengthening

With/without prosthesis (penile and/or testicular)

With/without colpectomy/colpocleisis
Metoidioplasty (with/without scrotoplasty) • With/without urethral lengthening

With/without prosthesis (penile and/or testicular)

With/without colpectomy/colpocleisis
Vaginoplasty (inversion, peritoneal, intestinal) • May include retention of penis and/or testicle
Vulvoplasty • May include procedures described as “flat front”
GONADECTOMY
Orchiectomy
Hysterectomy and/or salpingo-oophorectomy
BODY CONTOURING
Liposuction
Lipofilling
Implants • Pectoral, hip, gluteal, calf
Monsplasty/mons reduction
ADDITIONAL PROCEDURES
Hair removal: Hair removal from the face, body, and genital areas
for gender affirmation or as part of a preoperative preparation
process. (see Statement 15.14 regarding hair removal)

Electrolysis

Laser epilation
Tattoo (i.e., nipple-areola)
Uterine transplantation
Penile transplantation


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