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Principal Investigator: Rachel A Moses
Organization: DARTMOUTH-HITCHCOCK CLINIC
Fiscal Year: 2024
Award: $341,426
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Project Summary/Abstract
Metoidioplasty and phalloplasty gender affirming surgeries (MaPGAS) are increasingly performed but
remain high risk procedures that require patients to make complex decisions affecting future gender
congruence, fertility, urinary, and sexual function. Prior studies demonstrate there is decisional uncertainty
among transgender and non-binary individuals assigned female at birth considering MaPGAS which may lead
to poor decision quality and outcomes. In these high risk surgical decisions with multiple options with clinical
equipoise, it is paramount to empower patients with decision support that facilitates quality decisions that are
well informed, deliberated, and align with personal goals and values. However, there is a lack of validated
MaPGAS decision support due to a historical lack of understanding of patients’ decisional needs and dearth of
high quality published outcomes or guidelines. Taken together, this limits the extent of MaPGAS counseling
and shared decision making, potentially leading to poor quality decisions and unexpected outcomes.
In our prior R21 we used a mixed methods design grounded in the Ottawa Decision Support
Framework with community and provider stakeholders, to identify key themes surrounding patient surgical
goals, values, and decision moderators from geographically diverse locations in the US. This was combined
with a systematic review of the literature and modified Delphi consensus of high volume MaPGAS surgeons
on patient focused surgical outcomes to create, iteratively revise, and sandpit test a community developed,
web-based MaPGAS picture decision aid (DA) prototype. The DA provides information on the most common
MaPGAS options and a decision support tool applicable to patients of various health literacy levels.
The purpose of this study is to 1) evaluate the usability and acceptability of the MaPGAS DA using a
mixed methods approach including the validated System Usability Scale triangulated with key stakeholder
focus groups feedback. Further, to 2) evaluate preliminary MaPGAS DA efficacy through a prospective
randomized controlled trial at two geographically diverse institutions. The primary outcome includes change in
pre and post DA decisional conflict (Decisional Conflict Scale) and decision readiness (Preparation for
Decision Making Scale) as compared to usual care. The secondary outcome will include post-surgical
consultation evaluation with the CollaboRATE measure coupled with semi structured patient and provider
interviews on optimal DA administration timing, implementation, and impact on shared decision making.
Successful completion of this study will refine the MaPGAS DA, test preliminary efficacy, and inform a
larger prospective study designed to test broader acceptability, efficacy, and ultimately improve MaPGAS
shared decision making.
Terms: <Address><Affect><Body Tissues><Clinical><Collaborations><Communities><Complex><Conflict><Conflict (Psychology)><Consensus><Consult><Consultations><Counseling><Coupled><Decision Aid><Decision Making><Emotional><Equipoise><Evaluation><Fecundability><Fecundity><Feedback><Fertility><Fistula><Focus Groups><Future><Gender><Gender Affirming Surgery><Gender Confirmation Surgery><Gender and Sexual Minorities><Genital Organs><Genitalia><Geography><Goals><Guidelines><Health><Individual><Institution><Interview><Location><Measures><Methods><On-Line Systems><Online Systems><Operative Procedures><Operative Surgical Procedures><Outcome><Participant><Patient Recruitments><Patients><Phase><Population Heterogeneity><Preparation><Preparedness><Procedures><Prospective Studies><Prosthesis><Prosthetic device><Prosthetics><Provider><Publishing><QOL><Quality of life><Randomized><Randomized, Controlled Trials><Readiness><Recovery><Reporting><Research Design><Review Literature><Risk><Sampling><Sex Functioning><Sex Reassignment Surgery><Sexual Health><Sexual and Gender Minorities><Site><Skin><Staging><Structure><Study Type><Surgeon><Surgical><Surgical Interventions><Surgical Procedure><System><Testicles><Testing><Testis><Time><Tissues><Trauma><Travel><Uncertainty><United States><Urethra><Urethral Stenosis><Urethral Stricture><Urination><Work><assigned female at birth><assigned female gender at birth><assigned female sex at birth><care as usual><consultation><consults><cost><design><designing><diverse populations><doubt><empowerment><experience><feasibility testing><gender affirmation procedure><gender affirmation surgery><gender affirming procedure><health literacy><heterogeneous population><high risk><improved><infection risk><member><metoidioplasty><micturition><nonbinary><novel><online computer><participant recruitment><patient centered><patient oriented><patient retention><penis><phalloplasty><pilot trial><population diversity><preference><preparations><primary outcome><prospective><prototype><randomisation><randomization><randomized control trial><randomly assigned><recruit><reproductive organ><secondary outcome><sexual functioning><shared decision making><social><study design><support tools><surgery><surgery outcome><surgery risk><surgical outcome><surgical risk><systematic review><tool><trans*><transgender><treatment as usual><urethra stricture><urethral><urinary><usability><usual care><web based>