Methodology for the Development of SOC8

» 2.3 Development of Chapters

The Guideline Steering Committee, in discussion with chapter members, determined the chapters for inclusion in the Standards of Care, based on the previous editions of the SOC. Four new chapters were added. The chapters in the Standards of Care 8th Version are:

• Chapter 1. Terminology
• Chapter 2. Global Applicabilit
• Chapter 3. Population Estimates
• Chapter 4. Education
• Chapter 5. Assessment of Adults
• Chapter 6. Adolescents
• Chapter 7. Children
• Chapter 8. Nonbinary
• Chapter 9. Eunuchs
• Chapter 10. Intersex
• Chapter 11. Institutional Environments
• Chapter 12. Hormone Therapy
• Chapter 13. Surgery and Postoperative Care
• Chapter 14. Voice and Communication
• Chapter 15. Primary Care
• Chapter 16. Reproductive Health
• Chapter 17. Sexual Health
• Chapter 18. Mental Health

» 2.4 Methodology of the SOC8

Several stages have been followed to develop the SOC8:

1. Based on the SOC7 the topics were reviewed and main questions were developed
2. Systematic literature reviews were conducted where appropriate
3. Draft recommendations statements were developed by the chapters and reviewed by the chairs
4. Delphi process was followed in order to approve recommendations
5. Approved recommendations were Graded
6. Supportive text was added for each recommendation
7. Independent checking of references of chapters.

The SOC8 chairs have approved every step above.

2.4.1 Refine the Topics and Review Questions

The Evidence Review Team abstracted 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 the following was decided:

• recommendation statements that need to be updated
• new areas requiring recommendation statements
• systematic reviews required

Chapter Members developed possible statements and with the support of the evidence review team the decision is made as to whether a systematic review for the draft statements were required.

For the statements requiring a systematic review, the Evidence Review Team drafts review questions, specifying the population, interventions, comparisons, and outcomes (PICO elements). Chapter Leads and Members reviewed the review questions and provided feedback.

2.4.2 Conduct the Systematic Reviews

The Evidence Review Team conducted systematic reviews:

The Evidence Review Team presented evidence tables and other results of the systematic reviews to the members of the relevant chapter.

2.4.3 Drafting of the Recommendation Statements

Chapter Leads and Members drafted recommendation statements. The statements were crafted to be explicit and actionable. The statements were developed carefully following months of debates among the chapter members who had expertise regarding the specific area and were aware of the literature in the field. The statements were approved by the SOC8 chairs.

During this review any overlap between chapters was also addressed.

2.4.4 Approval of the recommendation following the Delphi Method

Following the advice of the Evidence Review Team (who are experts in the development of guidelines) the Delphi process was followed to approve the statements. The Delphi SOC8 process used the Research and Development/UCLA Appropriateness scale ranging from 1 (strongly disagree) to 9 (strongly agree). Every member of the SOC8 voted for each draft recommendation statement.

Agreement is defined as 75% of the SOC8 members scoring the statement 7, 8, or 9. Scores. Recommendation statements attaining agreement were not distributed for voting again in the next round of Delphi. Voters were asked to make comments when they don’t agree with a statement.

Recommendations that did not achieve agreement were returned to the respective chapter leads, and where necessary, all chapter members for revision. The comments from the voting process were provided. Once the statement is modified based on the comments the newly modified statements went through Delphi again.

A second and third round of voting was performed for all revised recommendations not reaching agreement. If a statement was not approved after 3 rounds, the statement was removed from the SOC8.

2.4.5 Grading

Once the statements of a chapter passed the Delphi process, chapter members graded each statement using GRADE. Recommendation statements either for or against an intervention/therapy/strategy and strength were indicated as either.

• We recommend
• We suggest

The strength of recommendation considers four domains:

1. The balance of potential benefits and harms
2. Confidence in that balance or quality of evidence
3. Values and preferences of providers and patients
4. Resource use and feasibility

Evidence-based recommendation statements may be strong or weak:

• 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 that effects will be achieved in practice)
  • there are few downsides of therapy/intervention/strategy
  • there is a high degree of acceptance among 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 patients or those for whom the recommendation applies.

Academic evidence as well as expert clinical evidence is used to reach the decision as to whether a recommendation is strong or weak.

2.4.6 Adding Supportive Text

Once the statements are approved, chapter member will write the text explaining the statement and the evidence using direct evidence or background evidence. Explanatory text follows each statement providing the rationale or reasoning for the recommendation. This includes outlining the available evidence, providing details about potential benefits and harms, a description of uncertainty, role of values and experience in developing the recommendation, and information about implementation of the recommendation, including expected barriers or challenges. References are used, using APA style, to support the information in the text. Links to resources can also be provided, as appropriate. Reasons as to why the statement is strong or weak should be clearly described. The text, including whether a recommendation has been described as strong or weak, will be reviewed and approved by the Chairs. In addition, references used to support the statements will be validated.

To maintain difference and help readers distinguish between recommendations informed by systematic reviews and those not, the statements should be followed by certainty of evidence for those informed by systematic literature reviews.

Only statements supported by the systematic literature review should be followed by:

++++ strong certainty of evidence
+++ moderate certainty of evidence
++ low certainty of evidence
+ very low certainty of evidence

The level of agreement from the final round of Delphi should be presented for each as an appendix at the end of the document (such as in a table).

» 2.5 Editing of the SOC8

An independent professional editor has been commissioned in order to edit the whole SOC8 in order for the SOC8 to read as written by one person.

» 2.6 Distribute Standards of Care for review

Once ready, the whole draft will be distributed via this website for comments from the WPATH members, the WPATH Global Trans Advisory Council, and open for comments for a period of one month. The comments will be reviewed by the SOC8 chairs and chapter leads and if appropriate and necessary changes will be made.

» 2.7 Disseminate the Standards of Care

The Standards of Care will be printed in a special edition of the International Journal of Transgender Health; this edition will be open access.

» 2.8 Plan to Update

The field of transgender health is rapidly evolving. Small adaptations/changes/addendums to the Standards of Care version 8 may take place. However, should new data become available that will significantly affect specific recommendations a revision of the SOC8 will be considered by a newly to be formed SOC8 Revision Committee. The SOC8 Revision Committee will be recruited and established after the completion and publication of the SOC8.