Evidence map›Paper›PMID 30344182›Full record

ArticleBMJ open2018

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 Pc Kreukels, Giancarlo McEvenue, Shane D Morrison, Margriet G Mullender, Lotte Poulsen, Mujde Ozer, Will Rowe and 8 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Anne F KlassenMcMaster University, Hamilton, Ontario, Canada.
Manraj KaurMcMaster University, Hamilton, Ontario, Canada.
Natasha JohnsonMcMaster University, Hamilton, Ontario, Canada.
Baudewijntje Pc KreukelsDepartment of Medical Psychology, Amsterdam Public Health research institute, Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam, The Netherlands.
Giancarlo McEvenueMcLean Clinic, Mississauga, Ontario, Canada.
Shane D MorrisonDivision of Plastic Surgery, Department of Surgery, University of Washington Medical Center, Seattle, Washington, USA.
Margriet G MullenderDepartment of Plastic Reconstructive and Hand Surgery, Amsterdam Public Health Research Institute, Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam, The Netherlands.
Lotte PoulsenDepartment of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark.
Mujde OzerDepartment of Plastic Reconstructive and Hand Surgery, Amsterdam Public Health Research Institute, Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam, The Netherlands.
Will RoweMcMaster University, Hamilton, Ontario, Canada.
Thomas SatterwhiteBrownstein & Crane Surgical Services, Greenbrae, California, USA.
Kinusan SavardFleming College-Emeritus, Peterborough, Ontario, Canada.
John SempleWomen's College Hospital, Toronto, Ontario, Canada.
Jens Ahm SørensenDepartment of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark.
Tim C van de GriftDepartment of Plastic Reconstructive and Hand Surgery, Amsterdam Public Health Research Institute, Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam, The Netherlands.
Maeghan van der Meij-RossDepartment of Plastic Reconstructive and Hand Surgery, Amsterdam Public Health Research Institute, Center of Expertise on Gender Dysphoria, VU University Medical Center, Amsterdam, The Netherlands.
Danny Young-AfatAmsterdam University Medical Centers, Amsterdam, The Netherlands.
Andrea L PusicBrigham and Women's Hospital, Boston, Massachusetts, USA.

Funding

CIHR
6 · The paper itself

Abstract

introductionA 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.

Indexed as

Patient Reported Outcome MeasuresClinical Trials, Phase I as TopicFemaleGender DysphoriaHormone Replacement TherapyHumansInternationalityInterviews as TopicMalePsychometricsQuality of LifeTransgender Personsgender-qlgtbq+patient-reported outcomepsychometricsquality of lifetransgender

Identifiers

PMID30344182
PMCPMC6196938

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.