International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

Anne F. Klassen, Manraj Kaur, Natasha Johnson, Baudewijntje P. C. Kreukels, Giancarlo McEvenue, Shane D. Morrison, Margriet G. Mullender, Lotte Poulsen, Mujde Ozer, Will Rowe, Thomas Satterwhite, Kinusan Savard, John Semple, Jens Ahm Sørensen, Tim C. van de Grift, Maeghan van der Meij-Ross, Danny Young-Afat, Andrea L. Pusic

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. Methods and analysis This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. Ethics and dissemination This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.
Original languageEnglish
Article numbere025435
JournalBMJ Open
Volume8
Issue number10
DOIs
Publication statusPublished - 2018

Cite this

Klassen, Anne F. ; Kaur, Manraj ; Johnson, Natasha ; Kreukels, Baudewijntje P. C. ; McEvenue, Giancarlo ; Morrison, Shane D. ; Mullender, Margriet G. ; Poulsen, Lotte ; Ozer, Mujde ; Rowe, Will ; Satterwhite, Thomas ; Savard, Kinusan ; Semple, John ; Sørensen, Jens Ahm ; van de Grift, Tim C. ; van der Meij-Ross, Maeghan ; Young-Afat, Danny ; Pusic, Andrea L. / International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q). In: BMJ Open. 2018 ; Vol. 8, No. 10.
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title = "International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)",
abstract = "Introduction A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. Methods and analysis This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. Ethics and dissemination This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.",
author = "Klassen, {Anne F.} and Manraj Kaur and Natasha Johnson and Kreukels, {Baudewijntje P. C.} and Giancarlo McEvenue and Morrison, {Shane D.} and Mullender, {Margriet G.} and Lotte Poulsen and Mujde Ozer and Will Rowe and Thomas Satterwhite and Kinusan Savard and John Semple and S{\o}rensen, {Jens Ahm} and {van de Grift}, {Tim C.} and {van der Meij-Ross}, Maeghan and Danny Young-Afat and Pusic, {Andrea L.}",
note = "{\circledC} Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2018",
doi = "10.1136/bmjopen-2018-025435",
language = "English",
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Klassen, AF, Kaur, M, Johnson, N, Kreukels, BPC, McEvenue, G, Morrison, SD, Mullender, MG, Poulsen, L, Ozer, M, Rowe, W, Satterwhite, T, Savard, K, Semple, J, Sørensen, JA, van de Grift, TC, van der Meij-Ross, M, Young-Afat, D & Pusic, AL 2018, 'International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)' BMJ Open, vol. 8, no. 10, e025435. https://doi.org/10.1136/bmjopen-2018-025435, https://doi.org/10.1136/bmjopen-2018-025435

International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q). / Klassen, Anne F.; Kaur, Manraj; Johnson, Natasha; Kreukels, Baudewijntje P. C.; McEvenue, Giancarlo; Morrison, Shane D.; Mullender, Margriet G.; Poulsen, Lotte; Ozer, Mujde; Rowe, Will; Satterwhite, Thomas; Savard, Kinusan; Semple, John; Sørensen, Jens Ahm; van de Grift, Tim C.; van der Meij-Ross, Maeghan; Young-Afat, Danny; Pusic, Andrea L.

In: BMJ Open, Vol. 8, No. 10, e025435, 2018.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - International phase i study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

AU - Klassen, Anne F.

AU - Kaur, Manraj

AU - Johnson, Natasha

AU - Kreukels, Baudewijntje P. C.

AU - McEvenue, Giancarlo

AU - Morrison, Shane D.

AU - Mullender, Margriet G.

AU - Poulsen, Lotte

AU - Ozer, Mujde

AU - Rowe, Will

AU - Satterwhite, Thomas

AU - Savard, Kinusan

AU - Semple, John

AU - Sørensen, Jens Ahm

AU - van de Grift, Tim C.

AU - van der Meij-Ross, Maeghan

AU - Young-Afat, Danny

AU - Pusic, Andrea L.

N1 - © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2018

Y1 - 2018

N2 - Introduction A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. Methods and analysis This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. Ethics and dissemination This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

AB - Introduction A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. Methods and analysis This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. Ethics and dissemination This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

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