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Development and Assessment of a Patient-Reported Outcome Instrument for Gender-Affirming Care

Kaur, Manraj N; Rae, Charlene; Morrison, Shane D; Laungani, Alexis; Brassard, Pierre; Mullender, Margriet G; van de Grift, Tim C; Young-Afat, Danny A; Sørensen, Jens Ahm; Poulsen, Lotte; Cornacchi, Sylvie D; Graesser, Jack G; Igbokwe, Michelle Mistry; Satterwhite, Thomas; Pang, John H; Akhavan, Arya A; Hu, Allison; Johnson, Natasha; Cano, Stefan J; Savard, Kinusan; Mundinger, Gerhard S; Capitán-Cañadas, Fermín; Simon, Daniel; Capitán, Luis; Coon, Devin; Brydges, Hilliard T; Bluebond-Langner, Rachel; Rodriguez, Eduardo D; Zhao, Lee C; Armstrong, Kathleen A; Dean, Nicola R; Crittenden, Tamara A; Cannell, Zac A; Lane, Megan; Haley, Caleb A; Hsu, Jessica; Dy, Geolani W; Peters, Blair R; Berli, Jens U; Milano, Christina E; Lava, Christian X; Fan, Kenneth L; Del Corral, Gabriel A; Kaoutzanis, Christodoulos; Kalia, Nargis; Higuchi, Ty; Ganor, Oren; Subedi, Sangeeta; Douglass, Laura M; Hamidian Jahromi, Alireza; Hosseini, Helia C; Ihnat, Jacqueline; Parikh, Neil; Hu, Kevin; Alperovich, Michael; Ray, Edward C; Aref, Youssef; Hassan, Bashar A; Liang, Fan; Mundy, Lily; Chen, Mang L; Pusic, Andrea L; Klassen, Anne F
IMPORTANCE/UNASSIGNED:There is an urgent need for a validated gender-affirming care-specific patient-reported outcome measure (PROM). OBJECTIVE/UNASSIGNED:To field test the GENDER-Q, a new PROM for gender-affirming care, in a large, international sample of transgender and gender diverse (TGD) adults and evaluate its psychometric properties. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This international cross-sectional study was conducted among TGD adults aged 18 years and older who were seeking or had received gender-affirming care within the past 5 years at 21 clinical sites across Canada, the United States, the Netherlands, and Spain; participants were also recruited through community groups (eg, crowdsourcing platform, social media). The study was conducted between February 2022 and March 2024. Participants had to be capable of completing the instrument in English, Danish, Dutch, or French-Canadian. Eligible participants accessed an online REDCap survey to complete sociodemographic questions and questions about gender-affirming care they had received or sought (ie, to look, function, or feel masculine, feminine, gender fluid, or another way). MAIN OUTCOME AND MEASURES/UNASSIGNED:Branching logic was used to assign relevant instrument scales. Rasch measurement theory (RMT) analysis was used to examine the fit of the observed data to the Rasch model for each scale. Test-retest reliability and hypothesis-based construct validity of instrument scales were examined. The hypothesis was that instrument scale scores would increase with better outcomes on corresponding categorical questions. RESULTS/UNASSIGNED:A total of 5497 participants (mean [SD] age, 32.8 [12.3] years; 1837 [33.4%] men; 1307 [23.8%] nonbinary individuals; and 2036 [37.0%] women) completed the field test survey. Participants sought or had the following types of gender-affirming care: 2674 (48.6%) masculinizing, 2271 (41.3%) femininizing, and 552 (10.0%) other. RMT analysis led to the development of 54 unidimensional scales and 2 checklists covering domains of health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Test-retest reliability of the scales (intraclass correlation coefficient [average] >0.70) was demonstrated. Only 1 item (phalloplasty donor flap) had an ICC less than 0.70. As hypothesized, scores increased incrementally with better associated self-reported categorical responses. For example, among 661 participants who reported poor psychological well-being, the mean (SD) scale score was 45 (18) points; for those who reported excellent psychological well-being, the mean (SD) scale score was 85 (16) points (P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cross-sectional study of 5497 TGD adults, the instrument demonstrated reliability and validity. The instrument was validated in an international sample and is designed to collect and compare evidence-based outcome data for gender-affirming care from the patients' perspective.
PMCID:12008761
PMID: 40249619
ISSN: 2574-3805
CID: 5829042

Immunologic Pretreatment of Donor Tissue in Vascularized Composite Allotransplantation: A Systematic Review

Stead, Thor S; Laspro, Matteo; Brydges, Hilliard T; Chinta, Sachin R; Shah, Alay R; Rabbani, Piul S; Gelb, Bruce E; Rodriguez, Eduardo D
BACKGROUND:Vascularized composite allotransplantation (VCA) holds significant promise for patients with complex structural defects, providing solutions unattainable through traditional methods. Despite technical successes, graft rejection and ischemia-reperfusion injury (IRI) present major challenges, with high rejection rates even under modern immunosuppression protocols. This review synthesizes current literature on immunologic pretreatments (IPTs) designed to mitigate these issues, focusing on interventions applied to donor tissues between procurement and transplantation. METHODS:A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines identified 11 relevant studies, categorizing IPTs into donor tissue modification (DTM), deoxygenated perfusate, and oxygenation methods. RESULTS:DTM, the most common IPT method, shows promise in reducing immunogenicity and prolonging graft survival, primarily through techniques such as recipient bone marrow-derived cell conditioning and MHC-I knockdown using small interfering RNA (siRNA). Deoxygenated perfusate studies highlighted mitomycin C's potential in reducing immune response and extending graft viability. Oxygenation methods, aimed at minimizing IRIs, utilized perfusion techniques to maintain graft viability ex vivo. CONCLUSIONS:Although IPTs for extending graft survival have seen moderate clinical translation, those targeting immunogenicity remain largely experimental. This review underscores the potential of these IPT modalities to improve VCA outcomes by reducing rejection and IRIs. However, it also highlights the need for further research, particularly multi-center clinical trials, to validate these techniques for broader clinical adoption. This comprehensive synthesis aims to guide future studies and enhance clinical strategies for VCA, ultimately improving patient outcomes.
PMID: 40113491
ISSN: 1873-2623
CID: 5813652

The Effects of Perioperative Gender-affirming Hormone Therapy on Facial Feminization Surgery Adverse Events, Facial Features Addressed, and Esthetic Satisfaction: A Multimodal Analysis

Laspro, Matteo; Hoffman, Alexandra; Chinta, Sachin; Abdalla, Jasmina; Tran, David; Oh, Cheongeun; Robinson, Isabel; Rodriguez, Eduardo D
OBJECTIVE:Facial feminization surgery (FFS) treats gender dysphoria in transfeminine patients by addressing the facial bony and soft tissue components. Individuals seeking FFS may be taking gender-affirming hormone replacement therapy [gender-affirming hormone therapy (GAHT)]. This study aims to better characterize the GAHT's impact on venous thromboembolism (VTE) risk, surgical planning, and outcomes. METHODS:A systematic review and meta-analysis of the literature were carried out to assess the effect of perioperative GAHT continuation on VTE. Cochrane Q and I2 statistics measured study heterogeneity with the following meta-regression exploring these results. Simultaneously, a retrospective review of the senior author's FFS cohort was conducted to investigate GAHT duration's impact on FFS revision rate, complication incidence, and facial structures operated on. RESULTS:Eleven articles were included: 602 patients stopped GAHT, of whom 3 VTEs were recorded (0.49%). This is compared with one episode among the 925 who continued GAHT perioperatively (0.11%). Study heterogeneity was low (0%), but limited VTE sample size precluded meta-analytic conclusions. Gender-affirming hormone therapy duration does not impact the incidence of all-cause complications (P = 0.478), wound infection (P = 0.283), hematoma (P = 0.283), or VTE (P = 1). The only procedures significantly less associated with higher GAHT were tracheal shaving (P = 0.002) and mandibuloplasty (P = 0.003). Finally, the FFS revision rate was not associated with GAHT duration (P = 0.06). CONCLUSION/CONCLUSIONS:There is a paucity of data to assess the safety or harm of continuing GAHT in the FFS perioperative period. Thus, a shared provider-patient decision-making process examining the risks and benefits of GAHT perioperative continuation is warranted. As patients seeking gender-affirming care are diverse, a "one-protocol-fits-all" is not appropriate.
PMID: 39495542
ISSN: 1536-3732
CID: 5803542

From Selfies to Surgery: Unveiling Trends and Ethical Considerations in Facial Feminization on Instagram

Hoffman, Alexandra F; Laspro, Matteo; Chinta, Sachin; Tran, David L; Rodriguez, Eduardo D
Facial feminization surgery (FFS) is a critical gender-affirming intervention utilized to alleviate gender dysphoria. This study investigates the role of Instagram in shaping public perceptions and disseminating information about FFS. The authors analyzed the most recent 500 Instagram posts using the hashtag "#facialfeminizationsurgery" through a nonbiased data scraping platform between June 1, 2023 and October 13, 2023. Posts were categorized, for example, by tone, author, hospital, practice location, and whether it was a patient or physician-reported outcome. Of the posts, 85% connoted a positive tone. Health care providers and organizations posted 65.4% of content. Geographic breakdown showed that of posts written in English, 55% of health care providers were from the United States. The top 3 most frequently cited locations outside of the United States were India (25.2%), England (19.1%), and South Korea (16.0%). Common themes among posts were perception of FFS and whether it be deemed cosmetic or reconstructive, ethical considerations, and insurance/funding. 36% of posts were advertisements, and 20% were educational, which emphasized the role of social media in disseminating information. This study emphasizes the dynamic nature of social media and its large impact on FFS with regard to disseminating accurate information, navigating the patient-physician relationship, and posting ethical content. The demographics of the users and posts show growing global interest in FFS, a largely positive tone from users, and a large presence of health care workers. Lastly, Instagram is an educational tool for FFS and spreads awareness of insurance and issues faced by patients through first-hand perspectives.
PMID: 39283137
ISSN: 1536-3732
CID: 5719982

Demonstrating Agreement between Radio and Fluorescence Measurements of the Depth of Maximum of Extensive Air Showers at the Pierre Auger Observatory

Abdul Halim, A; Abreu, P; Aglietta, M; Allekotte, I; Cheminant, K Almeida; Almela, A; Aloisio, R; Alvarez-Muñiz, J; Yebra, J Ammerman; Anastasi, G A; Anchordoqui, L; Andrada, B; Andringa, S; Anukriti,; Apollonio, L; Aramo, C; Ferreira, P R Araújo; Arnone, E; Velázquez, J C Arteaga; Assis, P; Avila, G; Avocone, E; Bakalova, A; Barbato, F; Mocellin, A Bartz; Bellido, J A; Berat, C; Bertaina, M E; Bhatta, G; Bianciotto, M; Biermann, P L; Binet, V; Bismark, K; Bister, T; Biteau, J; Blazek, J; Bleve, C; Blümer, J; Boháčová, M; Boncioli, D; Bonifazi, C; Arbeletche, L Bonneau; Borodai, N; Brack, J; Orchera, P G Brichetto; Briechle, F L; Bueno, A; Buitink, S; Buscemi, M; Büsken, M; Bwembya, A; Caballero-Mora, K S; Cabana-Freire, S; Caccianiga, L; Caruso, R; Castellina, A; Catalani, F; Cataldi, G; Cazon, L; Cerda, M; Cermenati, A; Chinellato, J A; Chudoba, J; Chytka, L; Clay, R W; Cerutti, A C Cobos; Colalillo, R; Coleman, A; Coluccia, M R; Conceição, R; Condorelli, A; Consolati, G; Conte, M; Convenga, F; Dos Santos, D Correia; Costa, P J; Covault, C E; Cristinziani, M; Sanchez, C S Cruz; Dasso, S; Daumiller, K; Dawson, B R; de Almeida, R M; de Jesús, J; de Jong, S J; Neto, J R T de Mello; De Mitri, I; de Oliveira, J; Franco, D de Oliveira; de Palma, F; de Souza, V; de Errico, B P de Souza; De Vito, E; Del Popolo, A; Deligny, O; Denner, N; Deval, L; di Matteo, A; Dobre, M; Dobrigkeit, C; D'Olivo, J C; Mendes, L M Domingues; Dorosti, Q; Dos Anjos, J C; Dos Anjos, R C; Ebr, J; Ellwanger, F; Emam, M; Engel, R; Epicoco, I; Erdmann, M; Etchegoyen, A; Evoli, C; Falcke, H; Farmer, J; Farrar, G; Fauth, A C; Fazzini, N; Feldbusch, F; Fenu, F; Fernandes, A; Fick, B; Figueira, J M; Filipčič, A; Fitoussi, T; Flaggs, B; Fodran, T; Fujii, T; Fuster, A; Galea, C; Galelli, C; García, B; Gaudu, C; Gemmeke, H; Gesualdi, F; Gherghel-Lascu, A; Ghia, P L; Giaccari, U; Glombitza, J; Gobbi, F; Gollan, F; Golup, G; Berisso, M Gómez; Vitale, P F Gómez; Gongora, J P; González, J M; González, N; Goos, I; Góra, D; Gorgi, A; Gottowik, M; Grubb, T D; Guarino, F; Guedes, G P; Guido, E; Gülzow, L; Hahn, S; Hamal, P; Hampel, M R; Hansen, P; Harari, D; Harvey, V M; Haungs, A; Hebbeker, T; Hojvat, C; Hörandel, J R; Horvath, P; Hrabovský, M; Huege, T; Insolia, A; Isar, P G; Janecek, P; Jilek, V; Johnsen, J A; Jurysek, J; Kampert, K-H; Keilhauer, B; Khakurdikar, A; Covilakam, V V Kizakke; Klages, H O; Kleifges, M; Knapp, F; Köhler, J; Kunka, N; Lago, B L; Langner, N; de Oliveira, M A Leigui; Lema-Capeans, Y; Letessier-Selvon, A; Lhenry-Yvon, I; Lopes, L; Lu, L; Luce, Q; Lundquist, J P; Payeras, A Machado; Majercakova, M; Mandat, D; Manning, B C; Mantsch, P; Marafico, S; Mariani, F M; Mariazzi, A G; Mariş, I C; Marsella, G; Martello, D; Martinelli, S; Bravo, O Martínez; Martins, M A; Mathes, H-J; Matthews, J; Matthiae, G; Mayotte, E; Mayotte, S; Mazur, P O; Medina-Tanco, G; Meinert, J; Melo, D; Menshikov, A; Merx, C; Michal, S; Micheletti, M I; Miramonti, L; Mollerach, S; Montanet, F; Morejon, L; Morello, C; Mulrey, K; Mussa, R; Namasaka, W M; Negi, S; Nellen, L; Nguyen, K; Nicora, G; Niechciol, M; Nitz, D; Nosek, D; Novotny, V; Nožka, L; Nucita, A; Núñez, L A; Oliveira, C; Palatka, M; Pallotta, J; Panja, S; Parente, G; Paulsen, T; Pawlowsky, J; Pech, M; Pękala, J; Pelayo, R; Pereira, L A S; Martins, E E Pereira; Armand, J Perez; Bertolli, C Pérez; Perrone, L; Petrera, S; Petrucci, C; Pierog, T; Pimenta, M; Platino, M; Pont, B; Pothast, M; Shahvar, M Pourmohammad; Privitera, P; Prouza, M; Puyleart, A; Querchfeld, S; Rautenberg, J; Ravignani, D; Akim, J V Reginatto; Reininghaus, M; Ridky, J; Riehn, F; Risse, M; Rizi, V; de Carvalho, W Rodrigues; Rodriguez, E; Rojo, J Rodriguez; Roncoroni, M J; Rossoni, S; Roth, M; Roulet, E; Rovero, A C; Ruehl, P; Saftoiu, A; Saharan, M; Salamida, F; Salazar, H; Salina, G; Gomez, J D Sanabria; Sánchez, F; Santos, E M; Santos, E; Sarazin, F; Sarmento, R; Sato, R; Savina, P; Schäfer, C M; Scherini, V; Schieler, H; Schimassek, M; Schimp, M; Schmidt, D; Scholten, O; Schoorlemmer, H; Schovánek, P; Schröder, F G; Schulte, J; Schulz, T; Sciutto, S J; Scornavacche, M; Segreto, A; Sehgal, S; Shivashankara, S U; Sigl, G; Silli, G; Sima, O; Simkova, K; Simon, F; Smau, R; Šmída, R; Sommers, P; Soriano, J F; Squartini, R; Stadelmaier, M; Stanič, S; Stasielak, J; Stassi, P; Strähnz, S; Straub, M; Suomijärvi, T; Supanitsky, A D; Svozilikova, Z; Szadkowski, Z; Tairli, F; Tapia, A; Taricco, C; Timmermans, C; Tkachenko, O; Tobiska, P; Peixoto, C J Todero; Tomé, B; Torrès, Z; Travaini, A; Travnicek, P; Trimarelli, C; Tueros, M; Unger, M; Vaclavek, L; Vacula, M; Galicia, J F Valdés; Valore, L; Varela, E; Vásquez-Ramírez, A; Veberič, D; Ventura, C; Quispe, I D Vergara; Verzi, V; Vicha, J; Vink, J; Vorobiov, S; Watanabe, C; Watson, A A; Weindl, A; Wiencke, L; Wilczyński, H; Wittkowski, D; Wundheiler, B; Yue, B; Yushkov, A; Zapparrata, O; Zas, E; Zavrtanik, D; Zavrtanik, M; ,
We show, for the first time, radio measurements of the depth of shower maximum (X_{max}) of air showers induced by cosmic rays that are compared to measurements of the established fluorescence method at the same location. Using measurements at the Pierre Auger Observatory we show full compatibility between our radio and the previously published fluorescence dataset, and between a subset of air showers observed simultaneously with both radio and fluorescence techniques, a measurement setup unique to the Pierre Auger Observatory. Furthermore, we show radio X_{max} resolution as a function of energy and demonstrate the ability to make competitive high-resolution X_{max} measurements with even a sparse radio array. With this, we show that the radio technique is capable of cosmic-ray mass composition studies, both at Auger and at other experiments.
PMID: 38277596
ISSN: 1079-7114
CID: 5911672

Molecular Signature Associated With Acute Rejection in Vascularized Composite Allotransplantation

Cassidy, Michael F; Doudican, Nicole A; Frazzette, Nicholas; Rabbani, Piul S; Carucci, John A; Gelb, Bruce E; Rodriguez, Eduardo D; Lu, Catherine P; Ceradini, Daniel J
BACKGROUND/UNASSIGNED:A deeper understanding of acute rejection in vascularized composite allotransplantation is paramount for expanding its utility and longevity. There remains a need to develop more precise and accurate tools for diagnosis and prognosis of these allografts, as well as alternatives to traditional immunosuppressive regimens. METHODS/UNASSIGNED:Twenty-seven skin biopsies collected from 3 vascularized composite allotransplantation recipients, consisting of face and hand transplants, were evaluated by histology, immunohistochemistry staining, and gene expression profiling. RESULTS/UNASSIGNED:significantly predicted inflammation specific to vascularized composite allografts that required therapeutic intervention. CONCLUSIONS/UNASSIGNED:The mechanism of vascularized composite allograft-specific inflammation and rejection appears to be conserved across different patients and skin on different anatomical sites. A concise gene signature can be utilized to ascertain graft status along with a continuous scale, providing valuable diagnostic and prognostic information to supplement current gold standards of graft evaluation.
PMCID:11415116
PMID: 39310283
ISSN: 2373-8731
CID: 5802822

A Comprehensive Analysis of Genioplasty in Facial Feminization Surgery: A Systematic Review and Institutional Cohort Study

Gursky, Alexis K; Chinta, Sachin R; Wyatt, Hailey P; Belisario, Maxwell N; Shah, Alay R; Kantar, Rami S; Rodriguez, Eduardo D
PMCID:11721636
PMID: 39797264
ISSN: 2077-0383
CID: 5805392

Novel Osteomyocutaneous Flap Model for Vascularized Composite Allotransplantation

Tran, David L; Cassidy, Michael F; Chinta, Sachin R; Shah, Alay R; Huang, Ren-Wen; Rodriguez, Eduardo D; Ceradini, Daniel J
BACKGROUND/UNASSIGNED:Vascularized composite allotransplantation (VCA) has become a viable option for restoration of devastating injuries that are not amenable to conventional reconstructive techniques. However, the relative scarcity of procedures performed worldwide, as well as the potential for iatrogenic injury with biopsies, makes studying the immunopathogenesis of acute rejection challenging. Translational VCA research focuses on developing strategies to overcome these barriers with the use of animal models can be technically challenging and difficult to replicate without highly trained microsurgeons. METHODS/UNASSIGNED:We describe a modified model of a femur-based composite tissue allograft using an adapted vascular cuff anastomotic technique with a tunneled skin flap in a rodent model. RESULTS/UNASSIGNED:The use of a heterotopic osteomyocutaneous flap with a subcutaneously tunneled-skin paddle to the posterolateral aspect of the recipient rodent allows for ease of flap monitoring and reduces the risk of self-mutilation. A total of six transplantations were conducted with no signs of self-mutilation. Operative time decreased as our surgical technique improved, and long-term graft tolerance was possible under our immunosuppressive regimen. Additionally, we demonstrate cases of successful transplantation in both an allogeneic and syngeneic rodent model. CONCLUSION/UNASSIGNED:Animal models, although technically challenging, are a reliable and reproducible modality that has been used to investigate various aspects of VCA immunology. We describe the success of an osteomyocutaneous flap with a modified vascular cuff anastomosis that can be used by investigators with less experience in microsurgical techniques to further our understanding of VCA physiology. Furthermore, tunneling of the skin paddle reduces the risk of self-mutilation and other external factors affecting the graft.
PMCID:11295284
PMID: 39099676
ISSN: 2352-5878
CID: 5730472

Computerized Surgical Planning in Face Transplantation

Shah, Alay; Chinta, Sachin; Rodriguez, Eduardo D
Face transplantation (FT) has emerged as a critical intervention for patients with complex facial deformities unsuitable for conventional reconstructive methods. It aims to restore essential functions such as facial expression, mastication, and speech, while also improving psychosocial health. The procedure utilizes various surgical principles, addressing unique challenges of craniofacial complexity and diverse injury patterns. The integration of Computerized Surgical Planning (CSP) leverages computer-aided technologies to enhance preoperative strategy, intraoperative navigation, and postoperative assessment. CSP utilizes three-dimensional computed tomography, printing, angiography, and navigation systems, enabling surgeons to anticipate challenges and reduce intraoperative trial and error. Through four clinical cases, including a groundbreaking combined face and bilateral hand transplant, CSP's role in FT is highlighted by its ability to streamline operative processes and minimize surgical revisions. The adoption of CSP has led to fewer cadaveric rehearsals, heightened operative precision, and greater alignment with preoperative plans. Despite CSP's advancements, it remains complementary to, rather than a replacement for, clinical expertise. The demand for technological resources and multidisciplinary teamwork is high, but the improved surgical outcomes and patient quality of life affirm CSP's value in FT. The technology has become a staple in reconstructive surgery, signaling a step forward in the evolution of complex surgical interventions.
PMCID:11305830
PMID: 39118859
ISSN: 1535-2188
CID: 5730922

Reshaping Faces, Redefining Risks: A Systematic Review of Orthognathic Surgery Outcomes in Cleft Lip and Palate Patients

Chinta, Sachin R; Segrera, Sergio; Friedman, Rebecca; Shah, Alay R; Kantar, Rami S; Volk, Angela S; Staffenberg, David; Rodriguez, Eduardo D
PMCID:11477402
PMID: 39407762
ISSN: 2077-0383
CID: 5718502