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Patient-Reported Outcomes in Masculinizing Gender-Affirming Chest Surgery: Validation of the GENDER-Q Chest Scales

Haley, Caleb; Morrison, Shane D; Kaur, Manraj N; Rae, Charlene; Lane, Megan; Young-Afat, Danny A; van de Grift, Tim C; Dean, Nicola R; Armstrong, Kathleen A; Coon, Devin; Cannell, Zac A; Lava, Christian X; Cornacchi, Sylvie D; Laungani, Alexis; Mullender, Margriet G; Sørensen, Jens Ahm; Poulsen, Lotte; Graesser, Jack G; Satterwhite, Thomas; Hu, Allison C; Mundinger, Gerhard S; Brydges, Hilliard T; Hsu, Jessica J; Peters, Blair R; Berli, Jens U; Kaoutzanis, Christodoulos; Kalia, Nargis; Bluebond-Langner, Rachel; Ganor, Oren; Hamidian Jahromi, Alireza; Hassan, Bashar A; Liang, Fan; Pang, John H; Ray, Edward C; Del Corral, Gabriel A; Fan, Kenneth L; Mundy, Lily R; Pusic, Andrea L; Klassen, Anne F
INTRODUCTION/BACKGROUND:Masculinizing gender-affirming chest surgery is the most frequently accessed gender-affirming procedure. The GENDER-Q Chest scales were developed to better assess patient-reported outcomes in masculinizing gender-affirming chest surgery, yet previous psychometric assessment of these scales is limited. The objective of this study was to assess the construct validity of the GENDER-Q Chest scales (Chest, Nipples & Areolas, and Scars). METHODS:An international, cross-sectional study was performed to develop the GENDER-Q between February 2022 and March 2024. Individuals were included in this analysis if they had sought or received masculinizing gender-affirming chest surgery and completed the GENDER-Q Chest scale. Construct validity was assessed for each scale by testing a priori hypotheses. According to Consensus-based Standards for the Selection of Health Measurement Instruments guidelines, greater than 75% acceptance of hypotheses indicates sufficient evidence of construct validity. RESULTS:A total of 2,846 participants completed the GENDER-Q Chest scale. For the GENDER-Q Chest, Nipples & Areolas, and Scars scales, 95% (21/22), 79% (15/19), and 100% (12/12) of hypotheses were accepted for each scale, respectively. Patients who underwent surgery and do not currently need revisions reported the highest satisfaction, while patients who had not yet undergone surgery reported the lowest satisfaction. CONCLUSION/CONCLUSIONS:The GENDER-Q Chest scales evidenced construct validity to measure appearance of chest, nipples, and scars for individuals seeking or undergoing masculinizing gender-affirming chest surgery. The GENDER-Q Chest scales provide a robust, validated approach for assessing outcomes in this context and are well-suited for generating high-quality evidence on patient-reported outcomes.
PMID: 42418773
ISSN: 1365-2168
CID: 6063932

Intraoperative nerve blocks for pain reduction in robotic peritoneal flap vaginoplasty: A prospective cohort study

Vernice, Nicholas A; Lisk, Rebecca; Fitzmaurice, Bren; Oh, Cheongeun; Lee, Wen-Yu; Zhao, Lee; Bluebond-Langner, Rachel
BACKGROUND:Achieving adequate analgesia in patients undergoing vaginoplasty facilitates early ambulation, reduces postoperative morbidity and increases patient satisfaction. This study evaluated the use of intraoperative nerve blocks (transverse abdominis plane [TAP] block and perineal block) in reducing postoperative pain and decreasing opioid use in robotic-assisted peritoneal flap vaginoplasty. METHODS:A prospective cohort study of 150 consecutive adult patients undergoing robotic peritoneal flap vaginoplasty performed by the senior authors was conducted at a single institution from December 2023 to October 2024. 75 consecutive patients who did not receive a block and 75 consecutive patients who did receive blocks were included based upon power analysis calculations with assumptions yielding 99% power. Demographic data as well as multimodal analgesic use was compared between groups with respect to use during the preoperative, intraoperative, and post anesthesia phases of care, as well as on each day of inpatient admission. RESULTS:Groups did not differ significantly in baseline characteristics. Block-treated patients demonstrated a significantly reduced total opioid requirement throughout their hospital stay, inclusive of intraoperative and perioperative dosing, as measured in total morphine milligram equivalents (MME) (median 675 versus 26 MME; p < 0.001). Block-treated patients required almost no oxycodone or hydromorphone after surgery with a median oxycodone dose of 0 mg compared with 33 mg in controls (p < 0.001); their total median hydromorphone dose was 0.4 mg versus 1.2 mg (p < 0.001). CONCLUSIONS:The block intervention achieved a dramatic reduction in total postoperative opioid use (oral and intravenous) throughout the hospital stay.
PMID: 41995367
ISSN: 1529-4242
CID: 6028282

Editorial Comment on "The Peritoneal Neovagina After Robotic-assisted Peritoneal Flap Gender-Affirming Vaginoplasty: A Morphologic and Histologic Investigation of the Neovaginal Lining"

Blasdel, Gaines; Bluebond-Langner, Rachel; Zhao, Lee
PMID: 40998055
ISSN: 1527-9995
CID: 5980102

"Gender-Affirming Vaginoplasty Using Robotic Peritoneal Flap Method: Long Term Outcomes of 500 Cases"

Blasdel, Gaines; Hemal, Kshipra; Dubach-Reinhold, Charlie; Parker, Augustus; Amro, Chris; Zhao, Lee C; Bluebond-Langner, Rachel
OBJECTIVE:The objective of this study was to determine the outcomes of robotic peritoneal flap vaginoplasty. BACKGROUND:There is a lack of long-term outcomes data for gender-affirming vaginoplasty to inform patient decision-making. METHODS:A retrospective cohort of 500 consecutive patients undergoing robotic peritoneal flap vaginoplasty from 2017-2023 were reviewed. Complications requiring procedural intervention, self-reported vaginal dimensions, and orgasm were recorded at each follow up visit and analyzed as outcomes. RESULTS:487 (97%) of patients were followed to 3 months, and 425 (85%) to 1 year or greater. Twenty patients (4%) had a complication requiring procedural intervention, and 61(12%) had elective revision surgery. Median self-reported vaginal depth and width at 1 year was 14.5 cm (14.5-14.5) and 3.8 cm (3.8-3.8 cm). There were 12 patients (4%) no longer dilating using standard dilators at this pre-scheduled 1-year appointment, and at last follow-up ≥1 year, 8% were no longer dilating. Thirty-six (8%) of patients were considered anorgasmic at last follow up. Difficulty with orgasm prior to surgery was associated with lower rates of achieving orgasm after surgery and less consistent vaginal depth at 1 year, however 80% of these patients were able to orgasm after surgery. CONCLUSIONS:Clinician-observed and patient-reported outcomes for robotic gender-affirming peritoneal flap vaginoplasty were superior to those reported in the literature for penile inversion vaginoplasty. Patients who do not achieve orgasm prior to surgery are less likely to achieve orgasm and maintain vaginal depth afterwards, however the majority of these patients have improved sexual health after surgery.
PMID: 39781707
ISSN: 1528-1140
CID: 5782012

Vaginoplasty Complications and Revisions

Parker, Augustus; Blasdel, Gaines; Bluebond-Langner, Rachel; Zhao, Lee
Choice of vaginoplasty technique is guided by the patient's natal anatomy, patient goals, and surgeon preference. The biggest distinction among techniques is the choice of lining for the vaginal canal. This chapter provides an overview of current data on the most pertinent complications, both universal and specific to different techniques for gender-affirming vaginoplasty. Clinical pearls for the management of these complications and indications for revision will be reviewed.
PMID: 41093465
ISSN: 1558-0504
CID: 5954862

Bridging the evidence gap in gender-affirming care: urgent research needs

Dolendo, Isabella; Zhao, Lee; Bluebond-Langner, Rachel; Anger, Jennifer T
Gender-affirming care has emerged as a critical component of healthcare, addressing the specific medical and psychosocial needs of transgender and non-binary individuals. In this review article, we address what we see as the most pressing evidence gaps in the gender health literature: long-term effects of pubertal blockers and gender-affirming hormone therapy and the lack of standardised outcome measures of gender-affirming care. Substantial uncertainties persist regarding long-term effects of hormone therapy and the implications of gender-affirming therapy on cancer risk. Though there is some uncertainty about the long-term effects of gender-affirming medical therapy, providers must also consider the potential negative consequences of prolonging a dysphoric experience. Additionally, there is a dearth of validated measures for patient-reported outcomes and a lack of standardisation in the reporting of data that is detrimental to the progress of understanding the impacts of gender-affirming care.
PMID: 40457589
ISSN: 1464-410x
CID: 5862202

Discussion: Mastectomy for Individuals with Gender Dysphoria Younger Than 26 Years: A Systematic Review and Meta-Analysis

Schechter, Loren; Berli, Jens Urs; Bluebond-Langner, Rachel
PMID: 40434656
ISSN: 1529-4242
CID: 5855362

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

Quantifying the Learning Curve in Robotic Peritoneal Flap Vaginoplasty

Hemal, Kshipra; Blasdel, Gaines; Parker, Augustus; Amro, Chris; Dubach-Reinhold, Charlie; Zhao, Lee C; Bluebond-Langner, Rachel
BACKGROUND:The learning curve (LC) is the process of mastering a new technique. This study assesses the LC for robotic-assisted peritoneal flap gender-affirming vaginoplasty (RPGAV). METHODS:A retrospective chart review of all consecutive patients undergoing RPGAV between 09/2017 and 02/2023 at a single center was performed. Operative times (OT) were analyzed to describe the LC. A cutoff point was determined after which OT stabilized, and this was used to compare perioperative and postoperative outcomes. RESULTS:Five hundred RPGAVs were performed. Median OT was 125 (interquartile range 105-181) minutes and decreased significantly over time. The minimum number of cases required to observe a plateau in OT is 300 patients.After adjusting for the LC, 2 variables significantly affected OT: a 1-point increase in body mass index increased OT by 1.4 minutes [95% confidence interval (1.0, 1.9), P < 0.001] and the single port robot decreased OT by 34 minutes [95% CI 1 (-43.1, -25.0), P < 0.001] as compared to the traditional multiport Xi robot.When comparing the first 300 cases (learning phase) to the last 200 (expert phase), length of stay, blood transfusions, and rates of elective revision surgery were lower in the expert phase. CONCLUSIONS:The LC for RPGAV in this large cohort was 300 cases. Patient body mass index causes a dose-response increase in OT and the single port robot dramatically decreases OT. Although OT is just one facet of overall efficiency, differences between learning and expert phases are evident in decreased length of stay, transfusions, and rates of revision surgery.
PMID: 40167061
ISSN: 1536-3708
CID: 5818952

Patient-centered outcomes on preparing for and undergoing gender-affirming phalloplasty: a qualitative, descriptive study

Mmonu, Nnenaya; Radix, Asa; Castle, Elijah; Zhao, Lee; Bluebond-Langner, Rachel; Ospina-Norvell, Clarissa; Harel, Daphna; Fendrick, Mark; Zhang, Tenny R; Berry, Carolyn A
OBJECTIVE:Despite increasing incidence of genital gender-affirming surgery (GGAS), there is no systematic method of evaluating patient perspectives. The objective of this study is to elucidate transgender and non-binary patient perspectives on gender-affirming phalloplasty/metoidioplasty via structured focus groups and determine convergent themes as the first step towards the development of a GGAS patient-reported outcome measure. DESIGN/METHODS:We conducted a systematic qualitative study using a thematic content analysis of four focus groups from April 2021 to April 2022 comprising 8 patients undergoing phalloplasty/metoidioplasty and 10 patients post-phalloplasty/metoidioplasty. Focus groups were hosted virtually and recorded and transcribed. Discussions were guided by participant input and focused on goals, experiences, outcomes, satisfaction, and quality of life. SETTING/METHODS:This volunteer but purposive sample of patients was recruited directly in clinic, via email, and via social media at NYU Langone Health (primary site), Callen-Lorde Community Health Center (New York, New York, USA) and the San Francisco Community Health Center. PARTICIPANTS/METHODS:We conducted focus groups with 18 patients before/after undergoing gender-affirming phalloplasty/metoidioplasty. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Transcripts were uploaded into ATLAS.ti, a qualitative data analysis software that facilitates coding for thematic content analysis. We performed deductive and inductive coding to identify the themes that were clustered into overarching domains. RESULTS:The mean duration of focus groups was 81.5 min. Seven themes and 19 subthemes were constructed. The major themes were (1) goals, expectations, and priorities before/after surgery; (2) sexual function; (3) urinary function; (4) peer support; (5) decision-making; (6) mental health and quality of life; and (7) gender dysphoria. Of the major themes, those determined before the study included themes 1-3 and 6-7. Limitations include small sample size and bias in patient selection. CONCLUSIONS:We conducted focus groups with 18 patients before/after undergoing gender-affirming phalloplasty/metoidioplasty. Mental health, quality of life, functional, and aesthetic outcomes are all critical to patients. Phalloplasty/metoidioplasty impact numerous aspects of patients' lives. Experiential components of the surgical process, mental health, and quality of life are important metrics to consider in addition to functional and aesthetic outcomes.
PMCID:11934403
PMID: 40122562
ISSN: 2044-6055
CID: 5814592