Standards of Care Appendix

This is intended as a supplement to the Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People. Content has not been changed but has been reformatted to reflect the original document.

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.

3. Overview of SOC-8 development Process

The steps for updating the Standards of Care are summarized below:

1. Establishing Guideline Steering Committee including Chair, and Co-Chairs (July 19, 2017)
2. Determining chapters (scope of guidelines)
3. Selecting Chapter Members based upon expertise (March 2018)
4. Selecting the Evidence Review Team: John Hopkins University (May 2018)
5. Refining topics included in the SOC-8 and review questions for systematic reviews
6. Conducting systematic reviews (March 2019)
7. Drafting the recommendation statements
8. Voting on the recommendation statements using a Delphi process (September 2019–February 2022)
9. Grading of the recommendations statements
10. Writing the text supporting the statements
11. Independently validating the references used in the supportive text
12. Finalizing a draft SOC-8 (December 1, 2021)
13. Feedback on the statements by International Advisory Committee
14. Feedback on the entire draft of the SOC-8 during a public comment period (November 2021–January 2022)
15. Revision of Final Draft based on comments (January 2022- May 2022)
16. Approval of final Draft by Chair and Co-Chairs (June 10, 2022)
17. Approval by the WPATH Board of Directors
18. Publication of the SOC-8
19. Dissemination and translation of the SOC-8

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 statements, 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 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. 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). 4. 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.

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”).

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.

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

1. Gender incongruence is marked and sustained;
2. Meets diagnostic criteria for gender incongruence prior to gender-affirming hormone treatment in regions where a diagnosis is necessary to access health care;
3. Demonstrates capacity to consent for the specific gender-affirming hormone treatment;
4. Other possible causes of apparent gender incongruence have been identified and excluded;
5. Mental health and physical conditions that could negatively impact the outcome of treatment have been assessed, with risks and benefits discussed;
6. Understands the effect of gender-affirming hormone treatment on reproduction and they have explored reproductive options.

Criteria for surgery

1. Gender incongruence is marked and sustained;
2. Meets diagnostic criteria for gender incongruence prior to gender-affirming surgical intervention in regions where a diagnosis is necessary to access health care;
3. Demonstrates capacity to consent for the specific gender-affirming surgical intervention;
4. Understands the effect of gender-affirming surgical intervention on reproduction and they have explored reproductive options;
5. Other possible causes of apparent gender incongruence have been identified and excluded;
6. 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;
7. 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

1. Gender diversity/incongruence is marked and sustained over time;
2. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary to access health care;
3. Demonstrates the emotional and cognitive maturity required to provide informed consent/assent for the treatment;
4. 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.
5. Informed of the reproductive effects, including the potential loss of fertility and the available options to preserve fertility;
6. Reached Tanner stage 2.

Hormonal treatments

1. Gender diversity/incongruence is marked and sustained over time;
2. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary to access health care;
3. Demonstrates the emotional and cognitive maturity required to provide informed consent/assent for the treatment;
4. 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.
5. Informed of the reproductive effects, including the potential loss of fertility and the available options to preserve fertility;
6. Reached Tanner stage 2.

Surgery

1. Gender diversity/incongruence is marked and ­sustained over time;
2. Meets the diagnostic criteria of gender incongruence in situations where a diagnosis is necessary to access health care;
3. Demonstrates the emotional and cognitive maturity required to provide informed consent/assent for the treatment;
4. 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.
5. Informed of the reproductive effects, including the potential loss of fertility and the available options to preserve fertility;
6. 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.

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.

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