Can we do better at measuring patient-reported outcomes after cranioplasty? A systematic review.

Measuring quality of life (QOL) after cranioplasty is increasingly evident as a necessary component of patient-centered care. For data to be useful in clinical decision-making and approval of new therapies, studies must utilize valid and reliable instruments. Our objective was to critically appraise studies evaluating QOL in adult cranioplasty patients and determine validity and relevance of the patient-reported outcome measures (PROMs) used. Electronic databases of PubMed, Embase, CINAHL, and PsychINFO were used to identify PROMs measuring QOL in adult patients with cranioplasty. The methodological approach, cranioplasty outcomes, and domains measured by the PROMs were extracted and summarized descriptively. A content analysis of the identified PROMs was completed to identify the concepts measured. From 2236 articles identified, 17 articles containing eight QOL PROMs met the inclusion criteria. None of the PROMs was specifically validated or developed for adults undergoing cranioplasty. The QOL domains included physical health, psychological health, social health, and general QOL. These four domains encompassed 216 total items among the PROMs. Appearance was only assessed in two PROMs. To our knowledge, there are currently no validated PROMs that comprehensively measure appearance, facial function, and adverse effects in adults undergoing cranioplasty. There is an urgent need to develop PROMs to measure QOL outcomes rigorously and comprehensively in this patient population to inform clinical care, research, and quality improvement initiatives. Findings from this systematic review will be used to derive an outcome instrument containing important concepts related to QOL in patients who undergo cranioplasty.

Nipple-Sparing Gigantomastia Breast Reduction: A Systematic Review.

INTRODUCTION: There remains an unclear definition of the term "gigantomastia," with many studies using different parameters and measurements. Currently, the operative management and patient education for gigantomastia are outdated. The historical teaching that a free nipple graft is necessary in elongated pedicles to avoid nipple necrosis may not be factual. The principal goal of our review aims to determine the safety of nipple-sparing breast reductions on large ptotic breasts via complication rate analysis. METHODS: The systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines of conduct for systematic review and meta-analysis. In October 2021, PubMed was used to search the US National Library of Medicine database. Rayyan Intelligent Systematic Review aided in screening studies by title then abstract. If inclusion criteria were met, the entire article was reviewed. RESULTS: Twenty-two articles satisfied the inclusion and exclusion criteria. The study was composed of 1689 total patients with a mean body mass index of 32.9 (±3.4). Mean midclavicle-to-nipple distance and resection weight per breast was 39 cm (±3.8) and 1423.8 g (±268.9), respectively. A Wise pattern was preferred in 77.3% of the studies, with an inferior (45.5%) and superomedial (45.5%) pedicle used most commonly. Complete nipple areolar complex necrosis (1.7%) was found in 4 studies, whereas partial (5.9%) was observed in 11. More common complications included delayed wound healing (17.4%), surgical site infection (14.3%), seroma (10.5%), scar hypertrophy (9.9%), and wound dehiscence (9.2%). CONCLUSION: Nipple-sparing breast reduction surgery can be safely performed on hypertrophic and severely ptotic breasts with nipple areolar complications, such as partial or complete nipple areolar complex loss, at a rate less than previously believed.

Primary Cleft Rhinoplasty: A Systematic Review of Results, Growth Restriction, and Avoiding Secondary Rhinoplasty.

BACKGROUND: Primary rhinoplasty during correction of unilateral cleft lip continues to be a topic of debate because of concerns that early nasal intervention may affect nasal and maxillary development over the long term. This study aims to determine the volume and quality of evidence for and against primary unilateral cleft rhinoplasty. METHODS: A systematic review was performed adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Articles were pulled from PubMed and EMBASE and screened by title and abstract. Studies with human participants undergoing rhinoplasty at the time of unilateral cleft lip repair and some evaluation of the nasal outcome were included. Studies with a large proportion of syndromic patients, case reports, editorials, letters, reviews, studies exclusive to bilateral clefts, and studies not available in English were excluded. Those that met criteria were then systematically reviewed. RESULTS: Twenty-five articles were included. Ten articles that assessed the results of primary rhinoplasty subjectively all supported cleft lip repair with primary rhinoplasty. Sixteen articles assessed the results of primary rhinoplasty objectively, with 15 supporting primary rhinoplasty during cleft lip repair. Eight of nine studies that evaluated nasal growth and development over time found no restriction in nasal development. Five studies with a follow-up period of at least 6 years found that the percentage of patients who avoided revision rhinoplasty ranged from 43% to 100%. There were significant risks of bias in the majority of studies. CONCLUSION: The majority of studies reviewed support that primary rhinoplasty during unilateral cleft lip repair results in good outcomes with limited or no effect on nasal growth.

Differences in Practice in Alveolar Bone Grafting Among American Cleft Palate-Craniofacial Association Members.

The purpose of this study is to determine areas of agreement and disagreement among American Cleft Palate-Craniofacial Association (ACPA)members in the clinical practice of alveolar bone grafting (ABG), to guide further research to optimize ABG practices.A cross-sectional survey was conducted.The respondents were in an academic, combination, or private practice.The respondents were either plastic or oral and maxillofacial surgeons (OMFS) from various countries.A de-identified 24-question online survey was distributed to ACPA surgeon members utilizing the Research Electronic Data Capture (REDCap) tool.Data collected included surgeon specialty, use of various alveolar bone graft surgical techniques, as well as protocols.There was more variability than consensus between specialties with regards to the preoperative workup, timing of surgery, materials used for bone graft, surgical techniques, perioperative management, and postoperative evaluation. There was consensus on grafting during mixed dentition, not staging soft and hard tissue closure, and using iliac crest for primary and secondary grafting. Disagreements involved factors used to time the procedure and type of imaging used to assess viability. Technical differences involved incision type, part of bone grafted, use of minimally invasive technique, and material used for revisions.Aside from areas of consensus among surgeons on ABG, several areas, including use of bone substitutes in revision grafting, incision and type of iliac crest graft used during initial grafting, and postoperative protocols, had no consensus. These areas should be targets of further research to determine if there truly is an optimal method to perform ABG.The study was approved by the University of Illinois at Chicago Institutional Review Board. A de-identified 24-question online survey was distributed to surgeon members of the ACPA utilizing the REDCap tool on August 7, 2020. The survey questions consisted of multiple choice and multiple selection questions including an option to select "other" and specify the information in a blank space. Data collected included surgeon specialty, use of various alveolar bone graft surgical techniques, as well as pre and postoperative protocols. The full survey is included in online Supplemental material. Data analysis was performed in SPSS Statistics 27 (IBM Corp.). Descriptive statistics were performed, and chi-square was used to test for significant differences in survey responses between groups.

A Systematic Review of Primary Rhinoplasty in Patients With Bilateral Cleft Lip.

BACKGROUND: Primary rhinoplasty (PR)at the time of cleft lip repair is controversial. We previously performed a systematic review that supported PR during unilateral cleft lip repair. We now aim to determine whether the same idea translates to care of patients with bilateral cleft lip. METHODS: A systematic review was conducted adhering to Preferred Reporting Items for Systematic Reviews and Meta-analysis statement guidelines. PubMed and Embase databases were searched for studies that met our inclusion criteria: (1) English language, (2) human subjects, (3) rhinoplasty at the time of bilateral cleft lip repair, and (4) evaluation of nasal outcome. Studies were excluded in case of: (1) inclusion of a large proportion of syndromic patients, (2) case reports, (3) editorials, (4) letters, (5) reviews, and (6) exclusive to unilateral clefts. Out of 281 studies that showed up on initial search, 12 were included in our review. Research quality and level of evidence rating were determined for each study. RESULTS: Of the 12 included studies, 9 supported PR at the time of bilateral cleft lip repair; 8 studies evaluated nasal growth and found no restriction over time; 4 studies followed 158 patients to an average of 15 years and showed 77% did not need secondary rhinoplasty. CONCLUSION: Although the available literature supports PR in patients with bilateral cleft lip with respect to subjective and objective outcomes, nasal growth, and reducing the need for secondary/revision rhinoplasty, there are significant limitations, necessitating large volume studies.

The Impact of Hydrocephalus Shunt Devices on Quality of Life.

BACKGROUND: Despite advances in hydrocephalus shunt technology and improvement in hydrocephalus management, many patients have chronic disability and require multiple surgeries throughout their lifetime. There is limited data from patients' perspective regarding the impact of shunt devices on quality-of-life. METHODS: A cross-sectional survey was developed to evaluate the impact of shunt devices on patient quality-of-life. The survey was distributed via social media platforms of the Hydrocephalus Association, and patients self-selected to anonymously complete the online questionnaire. A literature review was performed to contextualize the findings from the survey. RESULTS: A total of 562 survey responses were obtained from a network encompassing 35,000 members. The mean age was 30 years old (0.5-87), and 65% identified as female. Eighty one percent underwent at least 1 shunt revision surgery, with a reported average of 10 shunt revision surgeries per patient (1-200 surgeries). Occlusion, shunt migration and infection were the leading causes for revision at 60%, 47%, and 35%, respectively. In addition, 72% of patients reported pain and discomfort from the device, and 68% expressed avoidance of certain activities due to "fear of bumping shunt." Despite numerous articles discussing shunt technology, a review of the literature indicated a paucity of studies specifically evaluating the burden of shunt devices from a patient/caregiver perspective. CONCLUSIONS: The findings from this study suggest long-term physical and psychosocial burden associated with shunt devices. Importantly, this study highlights the need for concerted efforts to develop validated tools to study patient reported outcomes as it relates to neurocranial implanted devices.

Translucent Customized Cranial Implants Made of Clear Polymethylmethacrylate: An Early Outcome Analysis of 55 Consecutive Cranioplasty Cases.

BACKGROUND: Large skull reconstruction, with the use of customized cranial implants, restores cerebral protection, physiologic homeostasis, and one's preoperative appearance. Cranial implants may be composed of either bone or a myriad of alloplastic biomaterials. Recently, patient-specific cranial implants have been fabricated using clear polymethylmethacrylate (PMMA), a visually transparent and sonolucent variant of standard opaque PMMA. Given the new enhanced diagnostic and therapeutic applications of clear PMMA, we present here a study evaluating all outcomes and complications in a consecutive patient series. METHODS: A single-surgeon, retrospective, 3-year study was conducted on all consecutive patients undergoing large cranioplasty with clear PMMA implants (2016-2019). Patients who received clear PMMA implants with embedded neurotechnologies were excluded due to confounding variables. All outcomes were analyzed in detail and compared with previous studies utilizing similar alloplastic implant materials. RESULTS: Fifty-five patients underwent cranioplasty with customized clear PMMA implants. Twenty-one (38%) were performed using a single-stage cranioplasty method (ie, craniectomy and cranioplasty performed during the same operation utilizing a prefabricated, oversized design and labor-intense, manual modification), whereas the remaining 34 (62%) underwent a standard, 2-stage reconstruction (craniectomy with a delayed surgery for cranioplasty and minimal-to-no implant modification necessary). The mean cranial defect size was 101.8 cm. The mean follow-up time was 9 months (range, 1.5-39). Major complications requiring additional surgery occurred in 7 patients (13%) consisting of 2 (4%) cerebrospinal fluid leaks, 2 (4%) epidural hematomas, and 3 (4%) infections. In addition, 3 patients developed self-limiting or nonoperative complications including 2 (4%) with new onset seizures and 1 (2%) with delayed scalp healing. CONCLUSIONS: This is the first reported consecutive case series of cranioplasty reconstruction using customized clear PMMA implants, demonstrating excellent results with regard to ease of use, safety, and complication rates well below published rates when compared with other alloplastic materials. Clear PMMA also provides additional benefits, such as visual transparency and sonolucency, which is material specific and unavailable with autologous bone. Although these early results are promising, further studies with multicenter investigations are well justified to evaluate long-term outcomes.