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The World Professional Association for Transgender Health’s (WPATH) new Standards of Care version 8 (SoCv8) have been published. Like earlier versions, SoCv8 will be used to justify insurance coverage and medical interventions for gender minority/trans people.
The Global Applicability section of SOCv8 refers to our systematic review (SR) of international clinical practice guidelines (CPGs) for gender minority/trans people . WPATH recognized the existence of a “wide range of valuable health care resources”(pS16), but appears to make oblique criticism about our SR missing resources, especially seven references “that explicitly draw on expertise from regions outside North America and Europe”(pS16). We examined these:
• Two could not have been included as they were published after our study - one password protected educational module, another single country guideline.
• Three studies appear in our excluded full studies table (W3) with reasons[5,6,7].
• An earlier version of one single-country guideline also appears in W3.
• The 2011 WHO guideline and 2016 update of the consolidated WHO guidelines that underpin an implementation document were already included. This implementation document was not identified by key opinion leaders we contacted. Given it aligns with WHO guidelines (reproducing its recommendations, Introduction Table 1 pxix), it too would not meet the SR inclusion criteria.
WPATH claim that SoCv8 “is based upon a more rigorous and methodological evidence-based approach than previous versions.”(pS247). Although there are presentational improvements (e.g. boxed numbered recommendations), flaws remain:
• Appendix A does not address the fundamental areas requiring improvement regarding evidence and methodology that we and others identified. There are no PICO questions answered by SRs with GRADE data.
• There is no consequent, explicit linking of the evidence to recommendations.
• Each recommendation does not have an evidence grade.
• Decisions on the strength of recommendation statements, worded as “we recommend” or “we suggest”, are not open and transparent because “The balance of potential benefits and harms” are mixed with “Confidence in that balance or quality of evidence”, “Values and preferences of providers and patients” and “Resource use and feasibility”.
• It is impossible to determine which factors were more or less important when panels made their judgments.
• Such important underpinning detail ought to be clear and available to “show the workings” to others.
Further aspects are perplexing. The statement “a systematic review regarding outcomes of treatment in adolescents is not possible”(pS46) seems strange, given well-known evidence reviews exist[14,15] but are omitted from SoCv8’s references. Statement 2.1 asserts “strong evidence demonstrating the benefits in quality of life and well-being of gender-affirming treatments” (pS18), yet is supported by 21 references without any explanations of the papers’ context or evidentiary validity. This is unconvincing to those external audiences used to judging clinical effectiveness by quality, not quantity.
SoCv8 is “based on the published literature (direct as well as background evidence) [and] on consensus-based expert opinion”(pS247) including a Delphi process, but evidence curation moved on long ago; WPATHs methods are prone to bias and are not “evidence-based”[16-20]. Advice to improve methods from the SoCv8 “guideline methodologist [who] assisted with the planning and development of questions and systematic reviews” may have been insufficiently appreciated. It is disappointing that our publication, conference presentation and correspondence with WPATH (Sept 30 and Oct 13 2021) remain unacknowledged, unchallenged and unaddressed.
It appears WPATH expects readers to faithfully accept potentially biased judgments of the literature rather than confidently submitting SoCv8 to open scientific scrutiny. SoCv8 could have been much better: its evidence base and recommendations cannot yet be relied upon.
1 Coleman E, Radix AE, Bouman WP et al. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. International Journal of Transgender Health 2022; 23:sup1, S1-S259. doi: 10.1080/26895269.2022.2100644
2 Dahlen S, Connolly D, Arif I, et al. International clinical practice guidelines for gender minority/trans people: systematic review and quality assessment. BMJ Open 2021;11:e048943. doi: 10.1136/bmjopen-2021-048943
3 APTN. Towards transformative healthcare: Asia Pacific trans health and rights module. Asia-Pacific Transgender Network 2022. Available from: https://weareaptn.org/resource/towards-transformative-healthcare-asia-pa...
4 Tomson A, McLachlan C, Wattrus C, et al. Southern African HIV clinicians society gender-affirming healthcare guideline for South Africa. Southern African Journal of HIV Medicine 2021; 22:1. https://doi.org/10.4102/sajhivmed.v22i1.1299.
5 Health Policy Project, Asia-Pacific Transgender Network and United Nations Development Program. Blueprint for the provision of comprehensive care for trans people and trans communities. 2015. https://weareaptn.org/2017/06/01/blueprint-for-the-provision-of-comprehe...
6 PAHO. Blueprint for the provision of comprehensive care for trans persons and their communities in the Caribbean and other anglophone countries. 2014. John Snow, Inc. https://iris.paho.org/handle/10665.2/31360
7 Oliphant J, Veale J, Macdonald J, et al. Guidelines for gender affirming healthcare for gender diverse and transgender children, young people and adults in Aotearoa, New Zealand. Transgender Health Research Lab 2018. https://patha.nz/Guidelines
8 Telfer M, Tollit M, Pace C, Pang, K. Australian standards of care and treatment guidelines for trans and gender diverse children and adolescents, Version 1.3.The Royal Children’s Hospital Melbourne 2020. https://www.rch.org.au/uploadedFiles/Main/Content/adolescent-medicine/au...
9 Telfer MM, Tollit MA, Pace CC, Pang KC. Australian standards of care and treatment guidelines for transgender and gender diverse children and adolescents. Medical Journal of Australia, 2018;209(3):132–136. https://doi.org/10.5694/mja17.01044
10 World Health Organization. Prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people: recommendations for a public health approach. Geneva: World Health Organization, 2011. https://www.who.int/hiv/pub/guidelines/msm_guidelines2011/en/
11 World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, 2016 update, 2016. Available: http://www.who.int/hiv/pub/guidelines/keypopulations/
12 World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. 2014. http://apps.who.int/iris/bitstream/10665/128048/1/9789241507431_eng.pdf?...
13 UNDP, IRGT. Implementing comprehensive HIV and STI programmes with transgender people: Practical guidance for collaborative interventions. United Nations Development Programme 2016. https://www.unfpa.org/sites/default/files/pub-pdf/TRANSIT_report_UNFPA.pdf
14 Heneghan C, Jefferson T Gender-affirming hormone in children and adolescents. Blog BMJ EBM Spotlight 2019. https://blogs.bmj.com/bmjebmspotlight/2019/02/25/gender-affirming-hormon...
15 Cass Review. NICE Evidence Reviews 2021. https://cass.independent-review.uk/nice-evidence-reviews/
16 Dufresne K. The Delphi Technique. Blog Students 4 Best Evidence 2017. https://s4be.cochrane.org/blog/2017/11/15/the-delphi-technique/
17 Ioannidis JPA. Professional societies should abstain from authorship of guidelines and disease definition statements. Circ Cardiovasc Qual Outcomes 2018;11:e004889. doi:10.1161/CIRCOUTCOMES.118.004889
18 Bewley S. What inhibits obstetricians implementing reliable guidelines? BJOG 2020;127:798.doi:10.1111/1471-0528.16177
19 AGREE Next Steps Consortium. The AGREE II Instrument [Electronic version], 2017. http://www.agreetrust.org
20 Wilson L, Robinson K. Understanding and Interpreting Guideline Recommendations Made with Insufficient Evidence. Paediatric Respiratory Reviews 2014. 16. doi:10.1016/j.prrv.2014.09.002.
21 Connolly D, Dahlen S, Asif I, Junejo M, Bewley S, Meads C. Systematic Review and Quality Assessment of International Clinical Practice Guidelines for Gender Minority or Trans People. Video poster presentation. WPATH 26th Scientific Symposium 6-8 Nov 2020