Background Outcome assessment in genital gender-affirming surgery (gGAS) has long been a heterogenous practice. Although two core outcome sets (COS) for masculinizing and feminizing gGAS have been previously established, the absence of standardized and validated outcome measurement instruments (OMIs) limits consistent reporting. The second phase of the GenderCOS project aimed to identify, evaluate, and recommend OMIs to standardize outcome assessment and facilitate adoption of the COS in gGAS research, ultimately enabling comparability and evidence synthesis. Methods The project followed the Core Outcome Measures for Effectiveness Trials (COMET) initiative standards and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for selecting OMIs for a COS. Phase 2 of the GenderCOS project was conducted from September 2024 to June 2025. Potential OMIs were identified through systematic reviews: PROSPERO: CRD42022347400 (inception to September 2023) and CRD42020223430 (inception to November 2020), clinical guidelines, and international expert consultations. All instruments relevant to at least one core outcome underwent quality and feasibility assessment. Consensus on the most appropriate OMIs and essential supplementary information was achieved through an international consensus process involving professional experts across multiple disciplines. Findings A total of 380 potential OMIs were identified through systematic searches. After domain- and COS- matching, 152 patient-reported outcome measures (PROMs) and 53 clinical OMIs were evaluated on quality and feasibility aspects. The consensus process among professional experts in gender-care, resulted in measurement recommendations for 19 of the 20 unique core outcomes. These recommendations endorse the use of validated PROMs for the included patient-reported outcomes (PROs) and adherence to existing clinical guidelines for clinical outcomes and adverse events. For the remaining outcome relating to feminizing gGAS, a measurement recommendation was made for the subgroup that underwent vaginoplasty only. Development of an OMI suitable for all feminizing gGAS is also recommended. Interpretation The GenderCOS provides the first consensus-based standardized measurement framework for core outcomes in gGAS. Its modular structure and inclusion of validated instruments enable harmonized reporting, data synthesis and evidence-based improvement in gGAS research. Funding None received.
Masculinizing genital gender-affirming surgery (mgGAS) refers to the array of various surgical techniques that can be offered to transgender and gender-diverse (TGD) individuals. However, due to the significant variation in outcome reporting, comparisons of these techniques in terms of safety and effectiveness remain challenging. Currently, it is not clear which outcomes TGD individuals consider most valuable and no consensus exists on which parameters should be measured. The lack of standardized outcome definitions and measurement instruments complicates efforts to synthesize data across studies. The GenderCOS project addresses these issues by identifying key outcomes for mgGAS that should be measured and reported consistently across all clinical trials, improving evidence-based practice and shared decision-making. The development of the mgGAS COS followed a multi-stage protocol (https://doi.org/10.1080/26895269.2023.2288881) and involved a multidisciplinary steering group of professionals and TGD individuals at all stages. The key phases included: i) a systematic literature review to identify reported outcomes, ii) collection of additional outcomes through focus groups and interviews with TGD individuals, iii) synthesis of clinician-reported and patient-reported outcomes into a preliminary outcome list, iv) a multi-stakeholder Delphi survey where outcomes were rated based on importance by professionals and TGD individuals, and v) a final consensus meeting to determine the core outcomes. The selection of appropriate measurement instruments will be addressed in future phases. Initially, 2077 unique outcomes were identified from literature and patient input. After aggregation, this list was reduced to 91 and then narrowed to 38 entries through expert input. These outcomes underwent an e-Delphi survey evaluation and further discussion during a consensus meeting to finalize the COS. A total of 10 core outcomes for mgGAS were established, which include patient-reported and clinical outcomes and adverse events (Table 1). The development of a Core Outcome Set for mgGAS marks a significant step towards standardizing outcome measurement in this field. This will enable more reliable comparisons of surgical techniques, improve guideline development, and support informed decision-making for TGD individuals. The definition of appropriate measurement instruments will represent the next critical step in optimizing individualized gender-affirming care. None.
Background:Feminizing genital gender-affirming surgery (gGAS) comprises various surgical procedures and techniques. Comprehensive knowledge of the outcomes of all procedures and techniques is fundamental for informed decision-making. However, in current research on feminizing gGAS there is significant heterogeneity in reported outcomes. Standardization of outcome measurement is therefore urgently required. This study aimed to develop a Core Outcome Set (COS) for feminizing gGAS. Methods:A multidisciplinary, international study steering group comprising 16 panellists from Europe, the United Kingdom, North America, and South America-including health care professionals and transgender individuals-was appointed to guide the development of a COS. The steering group convened on 16 June 2022, 28 September 2023, 2 May 2024, and 29 August 2024. The study involved three phases: (i) relevant outcomes were identified through a literature review and focus groups with transgender and gender-diverse people; (ii) stakeholders were invited to participate in an international Delphi study to reach consensus on the key outcomes; (iii) a consensus meeting was held to reach a final consensus on the COS. Findings:Initial data collection yielded 2621 unique outcomes. This number was reduced to 39 potential outcomes for the Delphi process through a structured selection process. The Delphi rounds encompassed February, May and July 2024 respectively. Following the consensus meeting in September 2024, a final list of 11 outcomes was agreed, of which six are patient-reported outcomes. Seven outcomes apply to all feminizing gGAS procedures and four are specific to vaginoplasty procedures involving the creation of a vaginal canal. Interpretation:Adoption of the COS for feminizing gGAS could ensure that the most relevant outcomes in clinical research are measured and reported in a standardized way. Future studies adopting these suggested outcome measures could reduce the heterogeneity of reported outcomes across studies and working to improve the quality of research and care. Funding:None received.
Background:Masculinizing genital gender-affirming surgery (gGAS) for transgender and gender diverse people encompasses a complex, heterogenous, and modular set of procedures. To enable evidence-based decision-making or meta-analysis, a uniformity of outcome research is needed. Currently, this is hindered by non-standardized outcome reporting. This study aims to develop a core outcome set (COS) for research on masculinizing gGAS to address this issue. Methods:An international, multidisciplinary study steering group was established, consisting of 16 professional experts (PE) and lived experience experts (LEE), to advise on and support the development of this COS. The steering group convened online on 16 June 2022, 28 September 2023, 2 May 2024, and 29 August 2024. Potential outcomes were identified through interviews and focus groups with LEE and a systematic literature review convened up to September 2023. LEE and PE were recruited globally via websites, social platforms, scientific meetings, patient organizations, and posters and invited to participate in three e-Delphi survey rounds. In the first round, participants rated each outcome's importance on a 5-point Likert scale and provided reasoning for their rating. In subsequent rounds, participants re-rated the outcomes using illustrative quotes and rankings based on prior ratings to refine consensus. Pre-defined criteria guided outcome inclusion and exclusion. A final online consensus meeting with LEE and PE finalized the COS. Findings:Initial outcome gathering identified 384 unique outcomes, of which 38 outcomes were selected for the e-Delphi survey rounds. Thirty-two LEE and 52 PE participants, most from Europe, the UK, and the USA, completed all three survey rounds (February, May, and July 2024). Final consensus was reached in September 2024 on including one clinical outcome, three adverse events, and six patient-reported outcomes in the COS for masculinizing gGAS. The core outcomes are sensibility in the neo-phallus, additional surgery, ability to achieve orgasm, sexual well-being, and satisfaction with neo-genital aesthetics. For urethral lengthening, additional core outcomes include neo-urethral fistula, stricture, and the ability to void while standing. For phalloplasty, additional outcomes are flap necrosis and donor site morbidity. Interpretation:Developing a COS for masculinizing gGAS is a crucial step towards standardized outcome measurement and reporting in clinical research. Implementation could facilitate data comparison, meta-analysis and evidence-based guideline development, ultimately improving personalized surgical care. Funding:None received.
Background: Worldwide, many different surgical procedures and techniques are being used for masculinizing genital gender affirming surgery (gGAS) in transgender and gender diverse (TGD) individuals. Studies reporting on masculinizing gGAS measure and report different outcomes, hindering comparison and thus evidenced-based treatment decision making. This study aims to systematically assess reporting heterogeneity in masculinizing gGAS studies to date. Methods: A systematic review in compliance with the Cochrane Handbook for Systematic Reviews of Interventions was conducted. A multi-database literature search was performed up to September 2023. Clinical studies reporting on outcomes after masculinizing gGAS (i.e. phalloplasty, scrotoplasty, metoidioplasty and coronaplasty) in TGD individuals were included. Data extraction included reported outcomes, their definitions, timing of assessment, measurement instruments used, and primary outcomes for risk of bias evaluation. Results: After screening 922 studies, 87 were included for data extraction. In total, 2077 individual (clinician- and patient reported) outcomes were reported, of which 1026 (49%) were defined. The provided definitions were inconsistent, and the degree of outcome specificity varied. Among the most reported outcomes were neo-urethral fistula (n = 104) and stricture (n = 81), partial (n = 56) and complete (n = 50) flap necrosis, hematoma (n = 36) and, tactile sensitivity in the neo-phallus (n = 36). Measurement instruments were stated for 987 (48%) outcomes, primarily using ad hoc questionnaires. The timing of outcome assessment was specified for 1116 (54%) outcomes, often described as follow-up periods ranging in duration. The primary outcome was declared in 36 (41%) studies. Conclusion: This review demonstrates an extensive use of ambiguous definitions, measurement tools and assessment times following masculinizing gGAS and highlights the necessity for standardization. Adoption of an agreed-upon Core Outcome Set (COS) for masculinizing gGAS could improve the comparability and reliability of research findings and ultimately improve the treatment decision-making process.
OBJECTIVES:To assess the expected duration of exposure of United Kingdom urology and plastic surgery trainees to the provision of gender affirming healthcare to transgender patients. This observational, cross-sectional survey asked UK training programme directors (TPDs) to report the volume of training in gender affirming care of transgender patients that urology and plastic surgery trainees are expected to receive. METHODS:A Google Form online questionnaire was distributed to each regional TPD in the UK both for plastic surgery and urology. RESULTS:Eleven of 14 TPDs in plastic surgery and 13 of 19 urology TPDs completed the survey with responses representing 487 trainees. The total estimated exposure of UK trainees to any aspect of gender affirming healthcare was a median of one hour of training per trainee per year (clinical or didactic). Thirteen deaneries reported that trainees received some (didactic or clinical) training in transgender care each year. Only eight of these deaneries reported provision of direct clinical training. The remaining eleven deaneries reported that trainees received no training in gender affirming care. No training was expected to take place for any trainee of either speciality within multi-disciplinary team meetings or in masculinising genital surgery. CONCLUSION:The above evidence demonstrates the low exposure of plastic surgery and urology registrar trainees to gender affirming care during their training years in the UK.
OBJECTIVE:To describe an easy-to-perform surgical refinement to create a meatal appearance in phalloplasty without urethral lengthening by using a triangular flap extension.METHODS:Transgender men undergoing phalloplasty without urethral lengthening are candidate for this flap extension. A triangular flap is drawn at the distal part of the flap. When the flap is raised, this triangle is raised with the flap and subsequently folded in the tip of the neophallus, thus creating a neomeatal appearance.RESULTS:We present this easy-to-perform technique, our experience and postoperative results. Two pitfalls of this technique are: (1) when it is insufficiently trimmed and thinned, it adds too much bulk to the phallic top and (2) when it is insufficiently vascularized, wound healing problems will occur; especially since the neophallus will swell in the immediate postoperative phase.CONCLUSION:Using a triangular flap extension is an easy method to create a neomeatal appearance.
Background: Worldwide an increasing number of transgender and gender diverse individuals are requesting genital Gender Affirming Surgery (gGAS). For both masculinizing and feminizing gGAS various procedures and techniques are employed. Current literature on gGAS reports heterogeneous, non-standardized and often ill-defined outcomes. Presently, no consensus exists on what outcomes should be evaluated in order to assess the clinical results and the effectiveness of these procedures, which precludes development of evidence-based treatment guidelines.Aims: This international consensus study aims to develop Core Outcome Sets (COS) for both masculinizing and feminizing gGAS. These represent the minimum sets of outcomes recommended to be measured and reported in all clinical trials pertaining to gGAS.Methods: Two Core Outcome Sets for masculinizing and feminizing gGAS will be developed in parallel by following the Core Outcome Measures in Effectiveness Trials (COMET) guidelines. The stages of development for each set are: i) Identify outcomes measured and reported in previous research through a systematic review of the literature; ii) Identify outcomes suggested by transgender and gender diverse individuals during focus groups and interviews; iii) Combine and structure the outcomes into a preliminary outcome list; iv) Conduct e-Delphi surveys among stakeholders (i.e. professionals in transgender healthcare and transgender individuals) in which all potential outcomes will be rated on level of importance; and v) Decide on the final COS during an online consensus meeting.Discussion: This study will produce minimum, core sets of relevant outcomes for gGAS, through reaching international consensus with key stakeholders, including transgender individuals. Development of these COS will enable the measurement and reporting of relevant and standardized outcomes, facilitating continued scientific advancement of this field.
BackgroundFeminizing genital gender affirmation surgery (fgGAS) may be an essential adjunct in the care of some transgender women and gender diverse individuals with gender incongruence. However, the comparison of different techniques of fgGAS may be confounded by variable outcome reporting and the use of inconsistent outcomes in the literature. This systematic review provides the most in-depth examination of fgGAS studies to date, and summarizes all reported outcomes, definitions, and the times when outcomes were assessed following these surgical interventions.Aims/Methods: This work intends to quantify the levels of outcome variability and definition heterogeneity in this expanding field and provides guidance on outcome reporting for future study authors. Candidate studies for this systematic review were sourced via an electronic, multi-database literature search. All primary, clinical research studies of fgGAS were included with no date limits. Paired collaborators screened each study for inclusion and performed data extraction to document the outcomes, definitions, and times of outcome assessment following fgGAS.ResultsAfter screening 1225 studies, 93 studies proceeded to data extraction, representing 7681 patients. 2621 separate individual outcomes were reported, 857 (32.7%) were defined, and the time of outcome assessment was given for 1856 outcomes (70.8%) but relied on nonspecific ranges of follow-up dates. "Attainment of orgasm", "Neovaginal stenosis", and "Neovaginal depth/length" were among the most commonly reported outcomes. Profound heterogeneity existed in the definitions used for these and for all outcomes reported in general.DiscussionThe results demonstrate a need for clear outcomes, agreed definitions, and times of outcome assessment following fgGAS in transgender women and gender diverse individuals. The adoption of a consistent set of outcomes and definitions reported by all future studies of fgGAS (a Core Outcome Set) will aid in improving treatment comparisons in this patient group. This review is the first step in that process.
This work aimed to identify the lead causes of upper limb injury presenting to a busy hand and major trauma unit during the UK COVID-19 domestic lockdown period, in comparison to a cohort from the same period one year previously. Hand and upper limb injuries presenting to the host organization during a pre-lockdown period (23rd March 2019-11th May 2019) and the formal UK lockdown period (23rd March 2020-11th May 2020) were compared, using data collated from the host institution's hand surgery database. The UK lockdown period was associated with a 52% fall in the number of patients presenting to the service with hand and upper limb injuries (589 pre-lockdown vs. 284 during lockdown). There was a significant increase in the proportion of injuries due to machinery use during lockdown (38, 6.5% pre-lockdown vs. 33, 11.6% during lockdown, P = 0.009), other etiologies were consistent. The proportion requiring surgical management were similar (n = 272, 46.2% pre-lockdown vs. n = 138, 48.6% during lockdown, P = 0.50). The proportion requiring overnight admission fell (n = 94, 16.0% pre-lockdown vs. 29, 10.2% during lockdown, P = 0.022). COVID-19 related lockdown in the UK resulted in a reduction in the presenting numbers of hand related injuries; however almost half of these patients still required surgery. These data may be of use to other hand surgery centers for resource planning during future lockdown periods, and for injury prevention strategies in the post-COVID-19 world.
during the initial surgery. A decreased IP joint deviation after FPL centralization would suggest that the tendon was the main deforming force responsible for the deformity. Interestingly, there was decreased broadening of the radial aspect of the proximal phalanx, which may also indicate that a deforming force had been removed (Figure 2(b)). There remains some degree of deviation at 1-year follow-up, which may indicate either that there are other residual soft tissue abnormalities or that the deviation would eventually correct itself with more growth time. In conclusion, we recommend surgical exploration of radial polydactyly even in floatingtype cases, which may initially appear inconspicuous. This is especially relevant when there is a degree of joint deviation preoperatively.
Context: The fair comparison of treatment interventions for craniosynostosis across different studies is expected to be impaired by incomplete reporting and the use of inconsistent outcomes. Objective: This review assessed the outcomes currently reported in studies of craniosynostosis, and whether these outcomes are formally defined and prespecified in the study methods. Data Sources, Search Terms, and Study Selection: Studies were sourced via an electronic, multi-database literature search for “craniosynostosis.” All primary, interventional research studies published from 2011 to 2015 were reviewed. Data Extraction: Two independent researchers assessed each study for inclusion and performed the data extraction. For each study, data were extracted on the individual outcomes reported, and whether these outcomes were defined and prespecified in the methods. Data Synthesis and Results: Of 1027 studies screened, 240 were included and proceeded to data extraction. These studies included 18,365 patients. 2192 separate outcomes were reported. Of these, 851 outcomes (38.8%) were clearly defined, 1394 (63.6%) were prespecified in the study methods. “Clinical and functional” was the most commonly reported outcome theme (900 outcomes, 41.1%), and “patient-reported” outcomes the least (7 outcomes, 0.3%). “Duration of surgery” was the most commonly reported single outcome (reported 80 times). “Cranial index” was the most variably defined outcome (18 different definitions used). Conclusion: The outcomes reported following treatment interventions for craniosynostosis are incompletely and variably defined. Improving definitions for these outcomes may aid comparison of different management strategies and improve craniosynostosis care. Suboptimal prespecification of these outcomes in the study methods implied that outcome reporting bias cannot be excluded.
Background: Randomized controlled trials (RCTs) are gold standard assessments for healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) statement was published to maximize RCT reporting transparency. The authors conducted a systematic review to assess current compliance of RCTs published within craniofacial surgery with the CONSORT statement. Methods: The Thomson Reuters Impact Factor Report 2016 was consulted to identify craniofacial surgery journals. PubMed was used to search for recent RCTs published within the 5 journals identified. Two independent researchers assessed each study for inclusion and performed data extraction. The primary outcome was compliance of each RCT with the CONSORT statement. Secondary outcomes were the pathology and interventions examined, impact factor, multi-versus-single center, number of authors, and publication date. Results: Eighty-six studies met the inclusion criteria, across which a median of 56% (range 33%-94%) applicable CONSORT items were reported. The 5 least reported items were: trial design (3a); registration number and name of trial registry (23); who generated random allocation sequences, enrolled participants, and assigned participants to interventions (10); sample size determination (7a); mentioning "randomized trial" in the title (1a). Conclusion: The compliance of craniofacial surgery RCTs with the CONSORT statement requires improvement. Areas in need are identified, and methods to improve reporting transparency, are discussed.
This case report describes the clinical course of a child who developed staphylococcal scalded skin syndrome (SSSS) after a burn injury. The intent is to aid other units in recognizing the presentation of SSSS after a pediatric burn and to optimize subsequent management. The main clinical finding was of rapid, progressive, superficial epidermal loss at sites separate from the original burn, involving 55% of the total body surface area, 13 days after a 6% scald burn to the face, neck, and chest. Diagnosis was confirmed by multidisciplinary team clinical assessment and histopathology of an intraoperative skin biopsy. This confirmed epidermal cleavage at the granular cell layer. These findings were later supported by Staphylococcus aureus cultured from the burn wound, and a positive epidermolytic toxin A assay. Management was with general medical supportive care, clindamycin and flucloxacillin intravenous antibiotic therapy, and cleansing and dressing of the areas of epidermal loss. Key learning points from this case were that SSSS presented after a burn injury and that 13 days elapsed between the burn and SSSS. Factors differentiating it from toxic epidermal necrolysis are described, including the value of histopathology in confirming the diagnosis. The prompt use of antibiotics and attentive wound care are advocated as an effective management strategy.
Introduction: The Academic Surgical Collaborative (ASC) is a trainee research collaborative (TRC) formed in the UK in October 2014. Three years on, the achievements are presented along with advice for emerging and established TRCs. Methods: A retrospective review of internal, member-maintained ASC records was conducted. Membership numbers, PubMed indexed publications, presentations and prizes awarded were all calculated over time. Google Scholar was used to calculate citations per ASC publication. An online survey was distributed to members to ascertain member satisfaction. Results: With 62 active members (predominantly medical students) the ASC has published 33 PubMed indexed papers over three years, with a mean of 21 citations per paper (SD 89, range 0-491). 54 presentations have been delivered and eight prizes have been awarded for ASC research projects. 60% of ASC members believe the ASC delivers research that improves patient care. Key learning points for the ASC have been the use of a set of resources distributed to new members, the value of regular meetings, close mentoring throughout research projects to develop the skills of junior researchers, encouragement for junior members to present at conferences, and an ongoing focus on research conduct and improving evidence based medicine. Conclusions: The ASC has fulfilled many of its goals set out at its inception. The ASCs subsequent aims are to enhance existing research training for junior members, advances in the field of core outcome development and also multi-collaborative research.
The UK Academic Foundation Programme (AFP) is a two-year foundation programme that includes an additional "academic theme" undertaking work in research, management/leadership, or education and teaching activities. The limited number of AFP places makes the AFP application a highly competitive process. This article outlines points to consider when applying for the AFP and successful application strategies. Reviewed by successful AFP applicants, this article provides specific insight into applications to the London Academic Unit of Application (deanery).
BACKGROUND:Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction.METHODS:The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic.RESULTS:In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary.CONCLUSIONS:The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature.CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, V.
INTRODUCTION:It is expected that a child's first outpatient appointment with a craniofacial multidisciplinary team (MDT) instills anxiety in parents. Limited data exist on the aspects of the appointment that parents are most concerned about and what information they desire. The effect of written information provision on this cohort is unstudied.METHODS:Parents attending their child's first outpatient appointment with the Birmingham Children's Hospital Craniofacial MDT between September and December 2012 completed a questionnaire to identify concerns they had relating to the appointment. A patient information leaflet was subsequently developed and distributed. From September 2015 to January 2016, questionnaires completed by parents assessed the usefulness of the leaflet and whether it reduced parental anxiety.RESULTS:Twenty-six initial questionnaires were returned. Seventeen respondents (65%) reported that they were concerned about some aspect of their child's appointment. Twenty-two (86%) expressed a desire for more information surrounding their child's appointment. Thirteen (50%) requested for this information to be provided using a patient information leaflet. After the introduction of the leaflet, 30 questionnaires were returned. All 30 (100.0%) found the leaflet easy to understand. Twenty-nine (96.7%) felt the leaflet provided helpful information. Eighteen (60.0%) felt less worried about the appointment after reading the leaflet.CONCLUSIONS:The majority of parents of children referred to a craniofacial MDT appointment displayed concerns that related to the appointment itself. Specific information relating to the appointment process itself was desired. A purpose-built leaflet successfully provided parents with desired information and lowered anxiety among the majority of attendees.