The German Guidelines for Diagnosis and Treatment of Gender Incongruence and Gender Dysphoria of Childhood and Adolescence (2024)

In March 2024, the Association of Scientific Medical Societies in Germany (AWMF) published the final draft of the guidelines "Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment.” The AWMF is an important "pillar" in the German healthcare system, as it is the umbrella organization that organizes guideline updates and certifies treatment guidelines. The guideline development process was formally led by the German Society for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy (DGKJP), with 26 other medical organizations from Germany, Switzerland and Austria participating.The draft is scheduled to be voted on by the Boards for the 27 societies, and, if accepted, will be published in June 2024 as the final guideline.

Germany's draft recommendations immediately drew international attention for their marked departure from England'sCass Report recommendations.The divergence between the two is remarkable. The Cass Report recommended withdrawing puberty blockers from commissioned treatments for youth gender dysphoria, advised extreme caution regarding cross-sex hormone use, did not consider surgery as a possible option for minors, and asserted that most gender dysphoric youth should be treated psychotherapeutically. In contrast, Germany's draft recommendations relaxed the prior age and eligibility requirements for minors wishing to access body-modifying endocrine and surgical interventions, and asserted that the requirement that minors undergo psychotherapy prior to accessing body-modifying procedures is "not ethically justified for reasons of respect for the dignity and self-determination of the person."

Having analyzed the two sets of recommendations and the processes used to create them, it is apparent that their divergence can be largely explained by the difference in the assumptions about the role ofevidencein the process of making the recommendations. The Cass Report started with the assumption that the best treatment approach for gender dysphoric youth is unknown and commissioned 8 systematic reviews of evidenceto develop its recommendations. In contrast, the German guideline update started with the assumption that the reclassification of the ICD diagnosis of "gender incongruence" from a mental to a physical health condition (which itself reflected a "societal paradigm shift") demands that body-modifying procedures are available to all those who desire them—including minors. The intention to align treatment recommendations with the "societal paradigm shift" is stated in the guidelineregistration with AWMF in 2020, and isapparent in the approach that the guideline development team took toward the evidence, which appears to have served as a mere backdrop to an a priori decision to liberalize access to medical intervention for minors.

Originally, the updated German guidelines for treating gender dysphoric children and adolescents were supposed to carry the classification of "S3," which signifies the highest level, evidence-based guidelines. However,the guideline development team abandoned the systematic evidence search after 2019, stating it was no longer "feasible with the Commission's resources."The decision to stop systematically searching for the evidence during the last four years (2020–2023) resulted in a failure to systematically appraise 50% or more of the relevant evidence, depending on the topic (as the recent UK York systematic reviews commissioned by the Cass review demonstrated, more than 50% of the relevant studies were published after 2019). After the final draft was completed in early 2024, AWMF downgraded it from the originally intended highest-level "S3" evidence-based guidelines to their current lower status of S2K "consensus guidelines."

Our analysis concurs with the conclusion that the current draft of the guidelines cannot be graded as "S3" due to its failure to systematically assess much of the relevant evidence, and due to many other deviations from the evidence-based process as outlined by the AWMF-publishedGerman Instrument for Methodological Guideline Appraisal(DELBI). However, our methodological assessment suggests that even the lower S2K standard may not have been met. This additional concern deserves consideration, as any guidelines that are considered for implementation must be trustworthy. As theGerman Instrument for Methodological Guideline Appraisal(DELBI)states, "the primary aim of clinical practice guidelines is to enhance good clinical practice" by assessing "comprehensive knowledge (scientific evidence and clinical experience) about problems of care, to reconcile opposite views and to define current optimal practice by trading off benefits and harms." It does not appear that the basic requirement for trustworthy quality guidelines has been met.

Below, we present a brief summary of the content of the German guidelinerecommendations and list thekey methodological concerns (both sections contain detailed tables that can be expanded). We then discuss the evolution of the German approach to the care of gender-dysphoric/gender-incongruent children and adolescents. We conclude with the SEGM take-aways.

1. Guideline Recommendations

The "Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment” guideline contains 72 recommendation statements for 8 topics. All 72 are consensus-based, rather than evidence-based. The guideline methods "Leitlinienreport" report states that evidence-based guidelines were not possible because the quality of the evidence itself was weak:

"After the discussions on the literature-based evidence situation, it was clear to the steering group that there would be no evidence-based recommendations on individual interventions in the treatment of gender incongruence or gender dysphoria in this field due to a lack of controlled evidence of effectiveness and an overall weak evidence situation with regard to uncontrolled evidence of effectiveness from case-cohort studies."

However, the claim that evidence-based recommendations are not possible when the evidence is of low quality is inaccurate. Evidence-based recommendations are always possible regardless of the state of the evidence. The key requirement for a highly quality evidence-based guideline is not that the guidelines are based on high-quality evidence but that they are based on the best available evidence. This is achieved by conducting a systematic search, appraising the evidence for quality, and by basing the recommendations on the evidence while assigning an appropriate level of "strength" to each specific recommendation. This methodologically rigorous process was not followed in the case of the update to the German child and adolescent gender dysphoria guidelines.

Below is a brief summary of the recommendations contained in the draft guidelines:

• Comprehensive mental health assessment. The stated goal of the assessment is to establish the diagnosis of "stable/persistent gender incongruence or gender dysphoria" of adolescence (either ICD-11 or DSM-5)with "sufficient diagnostic clarity."How this should be achieved is not explained other than stating thatmental health professionals should "work out an individual assessment in a joint discussion with the affected person and theirguardians based on the overall picture of the existing psychological findings,the descriptionsand reflections of the affected person and their life story."Theguidelines acknowledge that "there are no empirically validated individualcriteria for determining the long-term stability/persistence of gender incongruence or genderdysphoria."
• Psychotherapeutic treatment.The guidelines state that"gender dysphoric children and adolescents presenting to health care facilities are more likely to have clinically relevant psychopathological abnormalities that go beyond reported gender dysphoric distress."If such conditions interfere with the clarity of diagnosis or success oftreatment, treatment should be offered, but not required: "an obligation to undergopsychotherapy as a condition for access to medical treatment is not ethically justifiedfor reasons of respect for the dignity and self-determination of the person."If an adolescent wishes to undergo medical or surgical gender transition, but the parents disagree, family therapy is recommended. Should an impasse be reached, the role of the therapist may include helping the young person emancipate from the parents to facilitate"shapingtheir life in accordance with their gender identity."
• Social gender transition (SGT).SGT (including social transition ofprepubertal children)is presented as likely beneficial intervention with non-existent risks. The guidelines recommend that the decisionwhether to undergo SGT should be led by the child and guided bychild's right to self-determination. Theinvolvement of mental health experts is only necessary to help the family adjust to the child's decision and to help the child and family manage any potential adverse societal reactions. Parentsare advised toremain open to the possibility that a child's identity may continue to change. Social transition is not necessary prior to undergoing treatment with PBs or surgery, however it is recommended (but not required) before starting cross-sex hormones.
• Puberty blockers (PB).PBs can be provided upon reaching Tanner stage 2 (earliest stage of puberty) and obtaining the diagnosis of "gender incongruence" (GI) or "gender dysphoria" (GD) which, according to the guidelines, signifies a "very probable persistent gender incongruence."The guidelines do not specify how to achieve this and acknowledge a lack of "empirically validated individualcriteria for determining the long-term stability/persistence of gender incongruence or genderdysphoria."There is no requirement of a pre-pubertal onset of GD/GI and no time criteria for the minimum duration of "concomitant body-related gender dysphoric distress."Unlike the "distress" criterion in tje DMS-5 diagnosis of GD,the distress in the context of the German guidelines can take the form of "an anticipatory fear"of the anticipatedpubertal body changes.While a comprehensive mental health assessment is listed as an "absolute requirement," PBs can be initiated "provisionally" ahead of the assessment ifthe pubertal changesarecausing an urgency to start the PB treatment. Overall, PBs are viewed as a fully reversible and likely beneficial intervention with likely minimal risks, which can be further mitigated by limiting the duration of puberty blockade.Fertility counseling appears to be recommended. The treatment is available to both teens with a cross-sex identification, as well as those who identify as non-binary.
• Cross-sex hormones (CSH).TheGI diagnosis with "concomitant body-related gender dysphoric distress"is required, with the additional criterion that the sense of incongruence should have lastedfor a "sufficiently long period of time." Theguideline team made a "deliberate decision against specifying a formal time frame" since the "inner coming-out"happens "before the gender incongruence is apparent to others," making the time frame impossible to validate.Acomprehensive mental health assessment is required, but treatment of co-occurring mental health conditions is merely "offered" but not required. Overall, CSHare viewed as a beneficial intervention, but their partial irreversibilityand the potential harms, especially harmto fertility, are acknowledged.Fertility counseling is recommended.The treatment is available to both teens with a cross-sex identification, as well as those who identify as non-binary.
• Surgery.Mastectomy or breast reductionrequires the diagnosis of GI and"concomitant body-related gender dysphoric distress"combined witha "clear desire for a change in the organ orcharacteristic to be operated on." Prior treatment with testosteroneis not required, but if it has occurred, then a 6 month waiting period before breast surgery is recommended to assure that both the identity and post-testosteronebreast size stabilize. Surgery is recognized as an irreversible step with profound consequences. Acomprehensive mental health assessmentis required, but attempts at psychotherapeutic treatment are not required as a prerequisite for surgery. The latterrecommendation isrecognized to be in conflict with the "current assessment guidelines of the Medical Service of the National Association of Statutory Health Insurance Funds (2020), according to which, before approval of the assumption of costs for gender reassignment surgery...additional proof must be provided that the GD could not have been treated sufficiently effectively with psychotherapeutic means alone." The treatment is available to both teens with a cross-sex identification, as well as those who identify as non-binary.

  Genital surgery (i.e. if an orchiectomy, ovariectomy or hysterectomy) is not allowed in minors due to German laws that prohibitmedical sterilization in minors.

Tables A1- A3 below present a more detailed analysis of the content of the recommendations comparing the German recommendations and rationale to those in the Cass Report. The Cass Report cautioned against social transition in pre-pubertal children and recommended caution in older adolescents; disallowed the use of puberty of blockers as a treatment for gender dysphoria; suggested "extreme caution" in the use of cross-sex hormones for both adolescents and young adults; and recommended psychosocial interventions as the first and likely only line of treatment for most youth (surgeries for minors, including mastectomies, have never been allowed in England). NHS England accepted the Cass Report's recommendations for implementation.

Table A1 – Social Gender Transition (SGT) Show table..

Table A2 – Puberty Blockers (PB)Show table..

Table A3 – Cross-Sex Hormones (CSH)Show table..

2. Methodological Issues

High-quality guidelines share the following characteristics: the recommendations are clear and actionable; theevidence is summarized using rigorous systematic review methods; theguideline panel considers all outcomes important to patients; and the guideline panel makes appropriate judgments in the interpretation of the evidence and the final recommendation.Having assessed the final draft of the guidelines "Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment" for methodological rigor, we conclude that it does not meet the standard for a credible evidence-based guideline.

While the guidelines acknowledge that their recommendations are not evidence-based, theywrongly state that evidence-based recommendations were not possible due to the low level of evidence. In explaining the reason for the downgrading of the guideline from its originally-intended S3 evidence-based guidelines to the current consensus-based S2k level, the guidelines provided this justification:

"Due to a lack of controlled evidence of efficacy and an overall weak evidence base with regard to uncontrolled evidence of efficacy from case-cohort studies, no evidence-based recommendations were made in this guideline for the treatment of GI or GD; instead, all recommendations were developed on the basis of consensus."

However, as is widely known,evidence-based guidelines can be created regardless of the level or strength of the available evidence. As long as a rigorous process for guideline development is followed, an evidence-based guideline can be produced even in the context of extremely limited, low-quality evidence.Below is a summary of the key methodological shortcomings of the study. This summary is followed by a detailed assessment that suggests that not only did the guidelines fail to meet the S3 criteria, but even the lower-level S2k criteria may not have been met.

• Systematicsearch for evidence stopped between 2017–2019.The decision by the guidelines committee to stop the systematic evidence search after 2019 (and for some topics, as early as 2017) led to a failure to systematically assess as much as 50% + of the relevant literature, depending on the topic (e.g., see Table 1A, "SEGM fact-check / Notes). The cessation of the systematic search so early in the guideline developmentrenders the recommendations not evidence-based; it omits a large body of recent literature, which is most applicable to the current populations of youth presenting with gender dysphoria/gender incongruence.
• The search for the evidence was conducted withoutclearly defined criteria.Even during the early timeframe when a systematic search was conducted, the approach to defining search criteria was inadequate. The study inclusion criteria were overly broad and vague (e.g., were articulated at a high level instead of stating it separately for each intervention; did not specify target outcomes; did not list comparator groups;did not specify study designs, etc).This makesthe guideline susceptible to concerns of bias over which studies were allowed toinfluencethe recommendations.
• The evidence was not critically appraised at the study level and notrated for certainty overall. While the guideline acknowledged that the overall quality of evidence was poor, the appraisal fell far short of what the AWMF "DELBI" standards for guideline appraisal consideradequate. Individual studies were notappraised for risk of bias (RoB), and the overall body of evidence was not appraised for quality/certainty using tools such as GRADE.Notably, the guidelines also misrepresentedthe findings of the NICE systematic review for puberty blockers, wrongly suggestingthat it concluded that puberty suppressionwas beneficial to young gender-dysphoric people.
• The recommendations werenot graded for strength. The hallmark of an evidence-based guideline is the grading of the guideline recommendations for strength. This tells guideline users how to interpret any givenrecommendation. The recommendations can be both "for" and "against" certain treatments, and they can be graded"strong" and"conditional." If a recommendation is graded as "strong," this indicates that almost all of the patients would benefit from (or would be harmed by)the intervention,while a recommendation graded as "conditional" suggeststhat the majority, but not all, of the patients would benefit (or would be harmed). None of the 70+ recommendations in the guideline are graded for strength using either a formal (e.g. GRADE) or a less formal method. Instead, only the strength of "consensus" is provided. However, according to theAWMF Guidance Manual and Rules for Guideline Development, the strength of consensus is provided in addition to the grading/rating of the strength of recommendation — not in place of it.
• There was no explicit link between the recommendations and the evidence base. None of the over70 topic-specific recommendations, including the specific recommendations regardingpsychotherapy, social transition, puberty blockers, cross-sex hormones, and surgery arelinked to a body of evidence that is graded for certainty. Instead, the guidelinesmake specific treatment recommendationsjustifying them by findings from individual studies (which were not assessed for risk of bias and frequently presented highly biased findings as a trustworthy basis for recommendations).
• Failureto properly engage stakeholders with a range of views representative of the relevant clinicianand patient communities.According to the AWMF "DELBI" standards for guideline appraisal, the guideline development effort should seek the engagementofprofessionals who will be tasked with implementing the recommendations, and patient/citizen groups whose care will be affected by the recommendations. While the guidelines did include professionals from 27 organizations, it appears that a diversity of views was lacking.
  • The failure to ensure intellectual diversity and manage disagreement was suggested by the fact that oneof the guideline steering committee members quit the effort.Theguideline methods "Leitlinienreport" report reveals that "Prof. Dr. med. Florian Daniel Zepf left the steering group at his own request after two years on thesteering group due to his stated professional ethical concerns and 'concerns regarding aspects ofchild and youth protection'.At no time was he entitled to vote in consensus conferences."
  • The failure to properly engage professionals with the dissenting opinions becameapparent when during the comment period, 15 Chairs and senior members of the Child and Adolescent Psychiatry Associationsubmitted a 100+ page dissenting opinion.
  • The failure to ensure a broad representation of opinions held by German clinicians was also evidentwhen theGerman Medical Assembly, which represents 250 delegatesrepresenting 17 German medical associations,passedresolutionIc-48 calling for a markedly different approach to treating gender-dysphoric youth than the one outlined in the draft guidelines. The resolutionasked to restrict all gender-transitioning treatments for youth to clinical trials.
  • The diversity of patient perspectives was also not represented, as evidenced by the dissentingopinionpublishedby severalparentstakeholdergroupsshortly after the draft guideline was completed.
• Failure tomanageconflicts of interest. Theguideline methods "Leitlinienreport" report states, "no conflicts of interest were found which have been considered problematic with regard to the involvement of the members of the guideline commission in the consensus process." However, adetailed analysisof the guideline development group's composition, complied by theparent groups,noted what appeared to besignificant intellectual and potential financial conflicts of interest for a number of the guideline development group members,and theirlack of independence from powerful interest groups that promote amedicalized approach to treating minors.

Our detailed methodological assessment of the German guidelines relative to the AWMF DELBI standard is presented in Table B below. Note:The DELBI instrument comprises 34 items across 8 domains, 7 of which are drawn from the internationally recognized AGREE II tool, with the eighth domainrelating to "applicability in the German healthcare system."A full assessment was out of scope, so instead we focused on the subset of the criteria which the AWMF listsas specifically differentiating between the level of guidelines (S1-S3).

Table B - Assessment of "Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment" relative to the DELBI standards outlined by AWMF.

Show table..

What is the appropriate "S" classification for the current draft guidelines?

The AWMF classifies guidelines fromS1 to S3. The "S1" rating is the lowest level, reserved for the guidelines based only on recommendations by experts; "S2" guidelines require a structured consensus process ("S2k") or a systematic literature review ("S2e"); while "S3" guidelines are based both on a systematic literature review, and employ a structured consensus process to make recommendations.

As mentioned earlier, the guidelines "Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment" were originally registered at the "S3" level, which represents the highest level, rigorous, and trustworthy guideline. The guideline draft continuedto carry the designation of S3 untilJanuary 2024. However, following a meeting with AWMF in January, the final draft was downgraded to "S2k."Two major reasons were offered publicly as the explanation for the downgrade. One was that the decision to downgrade the guideline was due to the poor quality of the evidence itself (a surprising explanation, as it is widely known that even when the evidence itself is of very low quality, it is possible to create high-quality evidence-based guidelines, as long as the process follows a high methodological standard).

Another stated reason for the downgrade was that this was merely a "preemptive" downgrade in anticipation of AWMF strengthening its S3 criteria, which would have rendered the guideline non-compliant with "S3" in the near future: the upcoming change in the S3 standard will require that at least 50% of the recommendations are evidence- rather than consensus-based. Of note, however, it appears that this requirement was already present in the2023 AWMF Guidance Manual and Rules for Guideline Development(p. 40, see below) and according to another AWMF document, it appears that this requirement may have been in place as early as July 2023(p. 3), a full 6 months before the guidelines were finalized.

In trying to understand the marked discrepancy between the Cass Report and the German draft recommendations, we embarked on assessing the guideline development process used by the German guideline development group using the "DELBI" standard. Our analysis suggests that not only do the guidelines fail to meet the stated future S3 requirements, but they fail to meet the S3 standard as it exists currently.Per the2023 AWMF Guidance Manual and Rules for Guideline Development(p. 57), S3 guidelines require assigning a formal "grade" to each recommendation*:

In the case of S3 guidelines, the formal consensus development process for adopting recommendations focuses on clinical aspects to judge the methodologically synthesised evidence. The recommendations are then discussed on this basis. Next, the strength of the recommendations is determined and agrade of recommendation assigned[emphasis added].

Byadditionally indicating the strength of consensus(percentage of agreement within the guideline development group) for each recommendation, the guideline users are given an impression of the extent to which all participants were in agreement.[emphasis added].

As our detailed analysis in Table B demonstrates, most of the S3 requirements have not been met. However, our analysis also suggests even the lower S2k level may not have been reached. According to the various AWMFdocumentationsources, while the S2guidelines do not require a formal grading of the evidence using structured tools such as GRADE, a less formal assessment of the quality of the recommendation is still required. In 2013 the AWMFmadeit clearthat for S2k guidelines, the consensus rating should be used in addition to, rather thaninstead of, providing a grading for the strength of the recommendation:

For consensus-based guidelines (S2k), the strength of recommendations is identified and adopted during the formal consensus process, although an indication of grades of recommendation (and levels of evidence) is not included because recommendations are not based on a systematic review of the evidence. Here, the strength of a recommendation is expressed in words only.Additionally,the strength of consensus (percentage of agreement within the guideline development group) can be indicated for each recommendation [emphasis added](p. 42).

The updated 2023AWMF Guidance Manual and Rules for Guideline Developmentlanguage is similar but less specific:

For consensus-based guidelines (S2k),the strength of recommendations is identified and adoptedduring the formal consensus process. Nevertheless, it is not planned to state schematic grades of recommendation or levels of evidence because recommendations are not based on any systematic processing of the evidence.The grade of a recommendation is expressed in words.

It further specifies however that the consensus is used to arrive at the ranking of the recommendation, rather than substitute it:

AWMF Guideline Register Rule: Classification of S2 and S3 guidelines (excerpt): If it is an S2k or S3 guideline:

• The methods for formulating recommendations are clearly described. This requires formal consensus techniques (e.g. consensus conference, nominal group process or Delphi method (see AGREE II Criterion 10).
• Every recommendation is discussed and voted on as part of a structured consensus development with a neutral moderator. The objectives are to find a solution to pending decision-making issues, toestablish a final ranking of the recommendations (S2k guideline)and determine the grade of recommendation (S3 guideline), and to measure the strength of consensus[emphasis added](p. 58)

The requirement that "the strength of the recommendation is expressed in words" also appears in the "aids and appendices" section for S2k.

There does not appear to be any clear indication of the strength of the recommendations (even informal) in the guidelines text. However, the requirementthat the "strength of the recommendation is expressed in words" is vague, andtherefore, it is unclear if theS2k criterion has been met. What is clear, however, is that the strength of consensus is not considered to be a substitute for the strength of recommendation by AWMF, as the two measure different constructs. The strength of consensus indicates the proportion of the guideline panel that agrees with the recommendation statement. The strength of the recommendation signals whether almost all, most, or only a few of the patients would benefit from the recommendation.

While it is up to AWMF to determine whether or not the rating/grading of the strength of the recommendation "expressed in words" criterion has been met, to the extent that S2k guidelines are considered credible for implementation by AWMF, the lack of any indication of the strength of the recommendation (formal and informal) is a key limitation of the current draft, regardless of the final AWMF rating.

*This text has been updated based on the 2023 AWMF Guidance Manual and Rules for Guideline Development (the prior language was based exclusivelyon the2012 AWMF Guidance Manual).

3. The Evolution of German Guidance to Care of Children and Adolescents

Like in other Western countries, the care for gender incongruent/gender dysphoric children and adolescents in the 21st century was largely informed by innovations in the care for gender-dysphoric mature adults in the 20th century. Germany occupies a special place in the history of adult gender medicine. In the 20th century, it was the German sexologist and founder of the Institute for Sexual Science in Berlin, Magnus Hirschfeld, who coined the term “transsexual” and oversaw the first “gender-affirming” procedures in the 1920’s-1930s. Later, Hershfield mentored his younger German colleague Harry Benjamin, who later immigrated to the United States, and became known as the founder of the field of gender medicine in the U.S. and worldwide in the 1950’s. Benjamin’s research led to the formation of WPATH, which, from its inception until 2006, carried Benjamin’s name.

Not only was Germany instrumental to initiating the practice of gender transitions, but it has been the worldwide leader in promoting the "depathologizing" approach to gender incongruence in adults.In 2015, the German Medical Association proposednew transgender guidelines during the World Medical Association (WMA), which asserted that “everyone has the right to determine one’s own gender,” that “gender incongruence is not in itself a mental disorder,” and recommended that “every effort be made to make individualised, multi-professional, interdisciplinary and affordable transgender healthcare (including speech therapy, hormonal treatment, surgical interventions and mental healthcare) available to all people who experience gender incongruence in order to reduce or to prevent pronounced gender dysphoria.” The WMA accepted the German proposal and adopted the guideline, with many medical associations worldwide (including the American Medical Association, who is a member of WMA) embracing it.

In contrast to the adult 2015 German guidelines, theoriginal German treatment guidelines for children and adolescents, written in 1999 and updated in 2013, retained a cautious approach to medicalizing gender-dysphoric youth. The guidelinesrequired youth to undergo psychotherapy for at least 1 year prior to commencing medical interventions to rule out the possibility of transient distress due to emerging sexuality or any other developmental struggles. For youth whose desired to transition persisted, an additional 1-year “real-life test” was required. Puberty blockers are allowed at Tanner stage 2, while the minimum age of cross-sex hormones is set at 16—but both treatments are only provided to those who were expected to continue to suffer from “life-long transsexualism.”

The 2013 guidelines recognized the significant uncertainty regarding the medicalization of gender-dysphoric minors. In addition to discussing the complexities of adolescent development, the 2013 guideline acknowledged that endocrine interventions in general, and puberty blockers in particular, could alter the natural psychosocial development, with a particular effect on gay youth.

To diagnose “transsexualism” (an ICD-10 diagnosis) in a young person, a number of conditions have to be ruled out first. Differential diagnosis included temporary distress, personality disorders, development of a hom*osexual orientation, or a “sexual maturation crisis,” especially in the cases where gender distress appeared “shortly before or during puberty.”

The 2013 guidelines were classified as "S1" (lowest level, as the consensus process was not "structured"). To be rated as an S1-level guidelines, "arepresentative group of experts from the specialist society(s) draws up a recommendation by informal consensus, which is finally approved by the board of the specialist society(s) and any other organizations involved."

As discussed above, this changed in 2020, when the AWMF—the umbrella organization for Germany’s medical societies which also organizes guideline updates—officially registered its plan to update the 2013 guideline for the management of gender dysphoria in youth. According to the guideline registration information, the primary justification for the update was a “paradigm shift” in the world whereby gender-related variance was no longer considered to be a form of mental illness. The registration specifically referenced the diagnostic change in ICD-11, which officially depathologized “gender incongruence” by removing this diagnosis from the mental health disorders section. The guideline registration did, however, mention that the approach to minors would take into account “particularities of the still incomplete biological development of maturity and identity and personality development in childhood and adolescence.”

The registration information provided additional detail on the planned guideline update. The “Guideline goal” section (“Zielorientierung der Leitlinie”) stated that the goal was to create a “valid guideline in which the treatment standards for childhood and adolescence are summarized with the greatest possible evidence-based and consensus among the professional associations involved in order to achieve an improvement in quality standards in medical care.” The "methodology" section (“Methodik”) referenced the plan to utilize systematic reviews of evidence as well as the use of a structured consensus process.

In accordance with this description, the guideline was registered as an S3 guideline, and in fact, the early draft in January 2024 still carried the S3 designation, suggesting the guideline will utilize a systematic review of evidence. As explained earlier, German guidelines can carry a designation from S1 to S3 depending on the rigor of the process. Guidelines classified as S1 are of the lowest quality, since they are based only on recommendations by experts; S2 guidelines require a structured consensus process (S2K) or a systematic literature review (S2E); while S3 guidelines include both elements.

Despite registering and publishing the guideline draft as “S3,” the draft had to be downgraded to “S2k” after the AWMF meeting in January. According to the process outlined by AWMF, the next steps include the meeting of the Boards of all 27 participating organizations, with the plan to vote on the adoption of the guideline in June 2024. Should the guideline be adopted, it will replace the 2013 version. However, it is unclear how binding the guidelines are, especially in light of the significant dissent from both professional and patient/community stakeholder groups, as discussed above.

SEGM Take-away

Guidelines exist to enable physicians, patients, and policy-makers to make informed decisions about treatments.While AWMFallows for these different "levels" of guidelines, the fundamental requirement that guidelines be trustworthy is not optional. TheGerman AWMF Instrument for Methodological Guideline Appraisal(DELBI)acknowledges that "the primary aim of clinical practice guidelines is to enhance good clinical practice" by assessing "comprehensive knowledge (scientific evidence and clinical experience) about problems of care, to reconcile opposite views and to define current optimal practice by trading off benefits and harms."DELBIrecognizes thatif a guideline is not viewed as reliable, it will not be accepted by the end users: "The effectiveness of guidelines depends on their acceptance and the reliability of their recommendations" (p. 9).

From the German AWMF/DELBI standard perspective, the current guidelines fall far below the originally intended S3 evidence-based guidelines. It appears that even the S2k level, which apparently the guideline has been certified at by AWMF, may not have been adequately met, since the guidelines failed to indicate the strength of recommendations (only the strength of consensus is provided, which is not sufficient per the AWMF documentation for S2k). More importantly, irrespective of the exact DELBI rating, treatment guidelines must be trustworthy. The requirement that guidelines should be evidence-based is no longer optional in the world of evidence-based medicine of the 21st century. As our analysis demonstrates, the"Gender Incongruence and Gender Dysphoria in Childhood and Adolescence: Diagnosis and Treatment" guidelines do not meet the basic requirement of credible, trustworthy, evidence-based guidelines.