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Developing a core outcome set for gender-affirming healthcare in transgender and gender diverse adults in Sweden using the Delphi approach : A study protocol

Dahlén, Lisann ; Pettersson, Klara ; Berglund, Frank ; Bodlund, Owe ; Dhejne, Cecilia ; Elfving, Maria LU ; Frisén, Louise ; Halldin-Stenlid, Maria ; Holmberg, Jenny and Holmberg, Mats , et al. (2025) In BMJ Open 15(7).
Abstract

Introduction 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. Methods Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella... (More)

Introduction 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. Methods 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. Analysis 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. Ethics and dissemination 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. Trial registration number COMET registration number 3223.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Health Services for Transgender Persons, Patient Reported Outcome Measures, Protocols & guidelines
in
BMJ Open
volume
15
issue
7
article number
e098300
publisher
BMJ Publishing Group
external identifiers
  • scopus:105010630750
  • pmid:40633945
ISSN
2044-6055
DOI
10.1136/bmjopen-2024-098300
language
English
LU publication?
yes
additional info
Publisher Copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.
id
0f451bdf-61ce-4b1f-a504-8019e54b82db
date added to LUP
2025-12-11 15:44:20
date last changed
2025-12-12 03:00:02
@article{0f451bdf-61ce-4b1f-a504-8019e54b82db,
  abstract     = {{<p>Introduction 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. Methods 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. Analysis 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. Ethics and dissemination 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. Trial registration number COMET registration number 3223.</p>}},
  author       = {{Dahlén, Lisann and Pettersson, Klara and Berglund, Frank and Bodlund, Owe and Dhejne, Cecilia and Elfving, Maria and Frisén, Louise and Halldin-Stenlid, Maria and Holmberg, Jenny and Holmberg, Mats and Högström, Jens and Indremo, Malin and Karvonen, Levi and Kratz, Gunnar and Nygren, Ulrika and Selvaggi, Gennaro and Skalkidou, Alkistis and Summanen, Edward and Södersten, Maria and Tivesten, Åsa and Clark, Kristen D. and Papadopoulos, Fotios C.}},
  issn         = {{2044-6055}},
  keywords     = {{Health Services for Transgender Persons; Patient Reported Outcome Measures; Protocols & guidelines}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{7}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Developing a core outcome set for gender-affirming healthcare in transgender and gender diverse adults in Sweden using the Delphi approach : A study protocol}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2024-098300}},
  doi          = {{10.1136/bmjopen-2024-098300}},
  volume       = {{15}},
  year         = {{2025}},
}