Outcome measures reported following feminizing genital gender affirmation surgery for transgender women and gender diverse individuals: A systematic review.

Background: Feminizing 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. Results: After 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. Discussion: The 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.

Triangular Flap Extension to Create a Meatal Appearance in Phalloplasty Without Urethral Lengthening.

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.

Outcome Measures Reported in Published Clinical Research Studies in Craniosynostosis: A Systematic Review.

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.

Assessing the Compliance of Randomized Controlled Trials Published in Craniofacial Surgery Journals With the CONSORT Statement.

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.

The Academic Surgical Collaborative: A three-year review of a trainee research collaborative.

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.

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

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.

Protocol for the development of a core outcome set for autologous fat grafting to the breast.

INTRODUCTION: One in eight women will develop breast cancer in their lifetime. Reconstruction is routinely offered to patients and can be autologous and/or implant based. One area of growing interest in autologous fat grafting (AFG). Our group recently published a systematic review and meta-analysis of this topic which showed 51 different outcomes were being utilized in the published literature, with substantial heterogeneity in their definitions. METHODS AND ANALYSIS: A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will first group these according to the six domains previously identified; oncological, clinical, aesthetic and functional, patient-reported, process and radiological. Through sequential rounds of voting, the long list of outcomes will be narrowed down using predefined rules of agreement. ETHICS AND DISSEMINATION: No patients will be involved in this study and ethical approval is not required. The research will be published in a peer-reviewed journal. It will also be presented at national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the appropriate audiences of surgeons and societies through email and other modes of communication.

The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction.

INTRODUCTION: There is growing interest in autologous fat grafting (AFG) for breast reconstruction. This systematic review examines the range of outcomes used across studies of AFG, their definitions and whether there is a need for a core outcome set to aid reporting. METHODS: Following the protocol of our systematic review, a search of 20 databases (1986 to March 2014) returned 35 studies which met the inclusion criteria. These were assessed independently by two authors. Disagreements were resolved by consensus. RESULTS: Of the 35 studies, 27 (77%) were case series, 5 (14.3%) were cohort studies, and 3 (8.6%) were case reports. A total of 51 different outcomes were reported. These studies each reported a median of five separate outcomes (range, 2-14), of which a median of 3 outcomes were defined (range, 0-14). A median of 2 outcomes per paper were prespecified in the study methods (range, 0-12) and a median of only 2 outcomes per paper (range, 0-12) were both defined and prespecified. The most commonly reported outcome in studies of AFG was that of "operative details," reported by 26 studies, and eight different outcome definitions were used. "Cancer recurrence" was reported by 20 studies, with the use of 10 different outcome definitions. Overall, there was a poor proportion of defined and prespecified outcomes that employed a wide range of different outcome definitions. In addition only 14/35 studies stated the number of patients lost to follow-up. CONCLUSIONS: There is a need for a core outcomes set for AFG to the breast to minimise outcome and reporting bias and aid evidence synthesis. Our future research will focus in this direction, titled VOGUE or Valid Outcomes for the Grafting of AUtologous Fat to the BrEast study. We invite all those interested to get in touch with the lead author.

From birth to maturity: midline tessier 0-14 craniofacial cleft patients who have completed protocol management at a single craniofacial unit.

INTRODUCTION: The rare craniofacial clefts form an important component of craniofacial pathology, but little has been written regarding the definitive management of affected patients. This report describes the presentation, management, and outcomes in a group of patients who have completed their protocol management for treatment of midline Tessier 0-14 clefts. METHODS: A retrospective review of the clinical, photographic, and radiographic records of all midline cleft patients treated at a single center was performed. Data describing each patient's presenting features, surgical management, and final outcomes are presented. RESULTS: Four patients were identified as having completed protocol management for Tessier 0-14 midline clefting at the unit. The age range at the most recent follow-up was 19.3 to 36.3 years. Three patients had entered protocol management during infancy, and the remaining patient presented to the unit at 13.8 years of age. The surgical management regimen is described in detail. Outcomes for development, hearing, speech, and vision at maturity were all acceptable. Three patients attained a respectable educational and social status. With respect to facial aesthetics scores, the only significant difference after management was a significant worsening of deformity in the region of the orbits. The Whitaker grade for repeat surgery improved after management (3.25 before to 2.63 postmanagement), but this improvement was not statistically significant. CONCLUSION: Presented are the results of the first cohort of midline Tessier 0-14 cleft patients to have completed protocol management at a single craniofacial unit. As more patients complete their management in the future, further refinements to the protocol could be made.