Dahlén Lisann, Pettersson Klara, Berglund Frank, Bodlund Owe, Dhejne Cecilia, Elfving Maria, Frisén Louise, Halldin-Stenlid Maria, Holmberg Jenny, Holmberg Mats, Högström Jens, Indremo Malin, Karvonen Levi, Kratz Gunnar, Nygren Ulrika, Selvaggi Gennaro, Skalkidou Alkistis, Summanen Edward, Södersten Maria, Tivesten Åsa, Clark Kristen D, Papadopoulos Fotios C
Department of Medical Sciences, Clinical Psychiatry, Uppsala Universitet, Uppsala, Sweden.
Patient association for transgender people, Stockholm, Sweden.
BMJ Open. 2025 Jul 8;15(7):e098300. doi: 10.1136/bmjopen-2024-098300.
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.
Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations' reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2-3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.
The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.
The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.
COMET registration number 3223.
尽管近年来与跨性别和性别多样化（TGD）人群（即那些因出生时被指定的性别与自身性别不符而感到不适或困扰的人）的性别确认治疗（GAT）结果相关的研究越来越多，但当前建议的证据基础并不理想。一个促成因素是所使用的结果和结果测量方法的异质性。本研究旨在通过制定一个基础核心结果集（COS）来应对这一挑战，该结果集将用于瑞典接受GAT的TGD成年人。
有效性试验核心结果测量倡议的建议将分四个阶段用于实现这一目标。第1阶段，将对GAT领域的同行评审文献和国际指南进行综合评价，以确定相关结果。在第2阶段，我们将通过审查患者和利益组织的报告以及一项匿名调查，征求TGD个体的意见，以确定具有个人重要性的结果。在第3阶段，使用德尔菲法进行2至3轮评估，研究人员、医疗保健专业人员、政策制定者和TGD成年人将根据感知到的重要性对确定的结果进行评分。在第4阶段，将召开一次共识会议，召集所有利益相关者群体的代表来确定核心结果集。
本研究的结果将包括一个针对瑞典TGD成年人GAT的核心结果集。将使用解释性分析来评估参与者的调查回复，以确定核心结果。在德尔菲法的每一轮中，将汇总李克特量表评分，以确定每一轮中哪些结果应推进或淘汰。
该研究已获得瑞典伦理审查局（于默奥医学部，注册号：2024 - 04672 - 01）的伦理批准。本研究的结果将以开放获取的方式发表，并通过TGD利益组织和瑞典性别焦虑研究网络进行传播。
COMET注册号3223。
