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BACKGROUND: The minimal important difference (MID) is vital to consider when interpreting the clinical importance of observed changes from surgical interventions assessed by patient-reported outcome measures (PROMs). There is no gold-standard for how to calculate MIDs, and uptake in plastic surgery literature is currently unknown, leading to methodological and interpretation issues. METHODS: Medline and Embase were searched to identify all plastic surgery randomized controlled trials (RCTs) employing PROMs as outcomes, and MID estimation studies for PROMs used by RCTs. Included studies were assessed for uptake and application of MIDs, and MID estimation methodology and values were categorized. RESULTS: A total of 554 RCTs employing PROMs as outcomes were identified. Of these, 419 RCTs had the possibility of incorporating a previously published MID. Uptake rate of MIDs was 11.5% (n=48/419). The most common ways MIDs were applied was to calculate sample size (37.5%) or to determine whether results were clinically important (35.4%). A total of 99 studies estimating MID values for the most common PROMs in plastic surgery, based on our review, were analyzed. The most common estimation methodologies were receiver-operator curve analysis (49%), change difference (31%), and standard deviation (25%). CONCLUSIONS: Our review highlights limited uptake and application of MIDs in plastic surgery. We propose four major barriers: 1) there existed no repository of published MIDs for PROMs used in plastic surgery; 2) available MIDs are not specific to plastic surgery populations; 3) high heterogeneity in MID estimation methodology; 4) wide ranges in MID values with no superior choice.
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Background: Rhinoplasty is one of the most common aesthetic plastic surgery procedures. Complications can lead to both aesthetic and functional impairments. The Consolidated Standards of Reporting Trials (CONSORT) Harms statement was developed to promote improved reporting of harm across randomized controlled trials (RCTs). Objectives: The aim of this systematic review is to assess harms reporting quality across RCTs on aesthetic rhinoplasty. Methods: A literature search was conducted in Ovid MEDLINE and Embase databases (January 1, 2005 to August 4, 2023). RCTs which compared 2 or more interventions in rhinoplasty with primarily aesthetic indications and assessed patient-important outcomes were included. The reporting quality was assessed by following a 40-item checklist endorsed by the 2022 CONSORT Harms Extension update. Results: A total of 58 RCTs met the inclusion criteria. Fifteen RCTs addressed harms of treatment in some capacity. Overall, the reporting quality across RCTs was poor, with a median CONSORT Harms score of 33% (range, 16%-83%). A reporting adherence of ≥50% was met by only 8 studies. There was no significant difference in reporting adherence between studies based on journal endorsement of CONSORT or industry vs nonindustry funding sources (P > .05). A high journal impact factor was significantly associated with a higher reporting quality (P = .044). Conclusions: CONSORT Harms reporting adherence was poor across the majority of included RCTs. Future trials on aesthetic rhinoplasty should aim to follow the reporting recommendations endorsed by the CONSORT Harms statement to increase transparency and minimize heterogeneity in harms reporting across studies.
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BACKGROUND: The test-retest (TRT) reliability of FACE-Q Aesthetic scales is yet to be assessed. The aim of this study was to establish the TRT reliability of 17 FACE-Q Aesthetic scales and determine the smallest detectable change (SDC) that can be identified using these scales. METHODS: Data were collected from an online international sample platform (Prolific). Participants ≥20 years old, who had been to a dermatologist or plastic surgeon for a facial aesthetic treatment within the past 12 months were asked to provide demographic and clinical information and complete an online REDcap survey consisting of 17 FACE-Q Aesthetic scales. Participants were asked if they would be willing to complete the survey again in 7 days. Only the participants who reported no important change in the scale construct and completed the retest within 14 days were included. RESULTS: A total of 342 unique participants completed the TRT survey. The mean age of the sample was 36.6 (±11.5) years, and 82.4% were female. With outlier data removed, all FACE-Q scales demonstrated an intraclass correlation coefficient >0.70 indicating "good" TRT reliability. The standard error of measurement for the included scales ranged from 3.37 to 11.87, corresponding to a range of SDCgroup from 0.95 to 3.23 and SDCind from 9.34 to 32.91. CONCLUSION: All included FACE-Q scales demonstrated sufficient TRT reliability and stability overall after the outlier data were removed. Moreover, the authors calculated the values for the SDC for these scales.
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Estética , Cara , Humanos , Femenino , Masculino , Reproducibilidad de los Resultados , Adulto , Encuestas y Cuestionarios , Persona de Mediana Edad , Satisfacción del Paciente/estadística & datos numéricos , Adulto JovenRESUMEN
Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared to the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial compared to subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on Medline, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies were included that assessed the use of the subfascial plane for breast augmentation. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and seven comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared to subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases risk of capsular contracture, hematoma, and rippling compared to the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings.
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BACKGROUND: Endoscopic posterior cervical foraminotomy is gaining popularity among endoscopic spine surgeons for the treatment of radiculopathy caused by foraminal stenosis. METHODS: This study describes a technique using the lateral decubitus position for endoscopic posterior cervical foraminotomy under monitored anesthesia care and local anesthesia only. RESULTS: A total of 10 patients with contraindications to general anesthesia underwent the procedure, resulting in improvement in cervical radicular pain with no perioperative complications. CONCLUSIONS: The findings suggest that this approach is a viable alternative for patients at high risk of general anesthesia care, expanding the surgical options for the treatment of radiculopathy.
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Anestesia Local , Vértebras Cervicales , Foraminotomía , Humanos , Foraminotomía/métodos , Anestesia Local/métodos , Masculino , Femenino , Persona de Mediana Edad , Vértebras Cervicales/cirugía , Anciano , Radiculopatía/cirugía , Radiculopatía/etiología , Posicionamiento del Paciente/métodos , Adulto , Neuroendoscopía/métodos , Resultado del Tratamiento , Estenosis Espinal/cirugía , Endoscopía/métodosRESUMEN
INTRODUCTION: Organized trauma systems reduce morbidity and mortality after serious injury. Rapid transport to high-level trauma centers is ideal, but not always feasible. Thus, interhospital transfers are an important component of trauma systems. However, transferring a seriously injured patient carries the risk of worsening condition before reaching definitive care. In this study, we evaluated characteristics and outcomes of patients whose hemodynamic status worsened during the transfer process. METHODS: We conducted a retrospective cohort study using data from the Pennsylvania Trauma Outcomes Study database from 2011 to 2018. Patients were included if they had a heart rate ≤ 100 and systolic blood pressure ≥ 100 at presentation to the referring hospital and were transferred within 24 h. We defined hemodynamic deterioration (HDD) as admitting heart rate > 100 or systolic blood pressure < 100 at the receiving center. We compared demographics, mechanism of injury, injury severity, management, and outcomes between patients with and without HDD using descriptive statistics and multivariable regression analysis. RESULTS: Of 52,919 included patients, 5331 (10.1%) had HDD. HDD patients were more often moderately-severely injured (injury severity score 9-15; 40.4% versus 39.4%, P < 0.001) and injured via motor vehicle collision (23.2% versus 16.6%, P < 0.001) or gunshot wound (2.1% versus 1.3%, P < 0.001). HDD patients more often had extremity or torso injuries and after transfer were more likely to be transferred to the intensive care unit (35% versus 28.5%, P < 0.001), go directly to surgery (8.4% versus 5.9%, P < 0.001), or interventional radiology (0.8% versus 0.3%, P < 0.001). Overall mortality in the HDD group was 4.9% versus 2.1% in the group who remained stable. These results were confirmed using multivariable analysis. CONCLUSIONS: Interhospital transfers are essential in trauma, but one in 10 transferred patients deteriorated hemodynamically in that process. This high-risk component of the trauma system requires close attention to the important aspects of transfer such as patient selection, pretransfer management/stabilization, and communication between facilities.
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Hemodinámica , Transferencia de Pacientes , Centros Traumatológicos , Heridas y Lesiones , Humanos , Transferencia de Pacientes/estadística & datos numéricos , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Heridas y Lesiones/mortalidad , Heridas y Lesiones/terapia , Heridas y Lesiones/complicaciones , Heridas y Lesiones/fisiopatología , Centros Traumatológicos/estadística & datos numéricos , Puntaje de Gravedad del Traumatismo , Pennsylvania/epidemiología , Anciano , Adulto JovenRESUMEN
Background: The World Health Organization has recommended the inclusion of human papillomavirus (HPV) vaccines in national immunization programs to address the global problem of cervical cancer. In the Philippines, HPV vaccination was introduced in a phased approach in 2015. This study seeks to estimate the cost of delivery of the HPV vaccination program and its operational context in the Philippines. Methods: This was a retrospective, cross-sectional micro-costing study focused on ongoing HPV vaccination delivery and its operational context across all levels of the health system. Using structured questionnaires and data collection from secondary sources, the weighted mean financial and economic costs and costs per dose at the national, subnational, and health facility levels were estimated. Results: The weighted mean financial and economic costs per dose of the HPV vaccination program aggregated across all levels of the health system were $US3.72and $29.74, respectively. Activities contributing most significantly to costs were service delivery and vaccine collection or distribution and storage at the health facility and administrative levels, respectively. The opportunity costs for health worker and non-health worker time accounted for 77% of the economic cost per dose. Conclusion: The total weighted mean financial and economic costs of HPV delivery are within range of those reported in other countries. Costing studies can help identify cost drivers with local operational context to help inform policymakers and program managers in budgeting and planning interventions to improve program implementation.
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Lithium (Li) metal is considered an ultimate anode owing to its high specific capacity and energy density. However, uncontrolled Li dendrite growth and low Coulombic efficiency have limited the application of Li metal. Among various strategies introduced to address these limitations, the surface modification of polyolefin separators with functional materials has been widely adopted for improving the mechanical and thermal stabilities of polymer separators and to protect the separator from the penetration of Li dendrites. Herein, we report a new functional polymer separator that is surface-altered with a graphene-based Li-ion flux regulator (GLR) to homogenize the Li-ion flux and suppress the growth of sharp dendritic Li in Li metal batteries. The nanopores distributed through the GLR structure serve as channels for ion transport and junctions for electron transfer, facilitating efficient electrolyte penetration and rapid charge transfer between graphene (Gr) sheets. Owing to these favorable features of porous GLR, a Li-Cu cell with the GLR surface-altered polypropylene separator (GLR-PP) delivers excellent cycle and rate performances compared to a Li-Cu cell with a Gr surface-altered polypropylene separator. In addition, among the tested cells, Li-sulfur cells with GLR-PP exhibit the most stable cycle performance over 500 cycles. These results demonstrate that the concept of tailoring the surface of a polymer separator with porous 2D materials is an effective strategy for improving the long-term cycle stability and electrochemical kinetics of Li metal-based batteries and would trigger further relevant studies.
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Background: Preeclampsia, a condition in pregnancy characterized by new onset high blood pressure and proteinuria, complicates 2%-8% of pregnancies globally. Early detection, careful monitoring, and treatment of high blood pressure are crucial in preventing mortality related to preeclampsia disorders. There is limited data that examines obstetric/gynecologic (OBGYN) provider-type practices concerning management of hypertensive disorders of pregnancy to reduce early onset preeclampsia (EOP). We assessed the knowledge and practice patterns of OBGYN management to reduce EOP. Methods: We conducted a semistructured survey with OBGYN residents, maternal-fetal medicine fellows, and attending physicians (OBGYN and family medicine) at a single academic medical center to assess the management of hypertensive disorders to EOP. Results: Thirty-one participants (71% residents/fellows 29% attendings) completed the survey. Seventy-eight percent of attendings indicated they discuss blood pressure and preeclampsia with all patients compared to 50% of residents/fellows (p = 0.31). Eighty-nine percent of attendings reported they are extremely likely to monitor high-risk patients compared to 36% of residents/fellows (p = 0.07). Conclusion: Attending physicians were more likely to appropriately manage hypertension in women at risk for pregnancy compared to residents/fellows. Further research is needed on monitoring high-risk patients.
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PURPOSE: To evaluate the role of performing photocoagulation up to ora serrata during vitrectomy in preventing recurrent vitreous hemorrhage (VH) in patients undergoing pars plana vitrectomy (PPV) for proliferative diabetic retinopathy (PDR). METHODS: This retrospective, nonrandomized study included 60 eyes from 60 patients who had undergone PPV for VH due to PDR. These patients were divided into two groups: group 1, those who underwent photocoagulation up to ora serrata using the scleral indentation technique during surgery; and group 2, those who did not undergo scleral indentation when photocoagulation and underwent photocoagulation up to vortex veins. Their hospital records were analyzed to investigate the recurrence rate of VH, the time until recurrence of VH after surgery, logarithm of the minimal angle of resolution (logMAR) best-corrected visual acuity (BCVA) measured before surgery and at 1, 2, and 3 years after surgery, and the occurrence of complications such as neovascular glaucoma (NVG) during follow-up. RESULTS: Group 1 exhibited lower recurrence rate of VH (2 of 30 [6.7%] vs. 10 of 30 [33.3%], p = 0.01) and lower occurrence of postoperative NVG (2 of 30 [6.7%] vs. 8 of 30 [26.7%], p = 0.038) compared with group 2. There were no statistically significant differences in logMAR BCVA measured at 1, 2, and 3 years between the two groups (at 1 year: 0.54 ± 0.43 vs. 0.54 ± 0.44, p = 0.954; at 2 years: 0.48 ± 0.47 vs. 0.55 ± 0.64, p = 0.235; at 3 years: 0.51 ± 0.50 vs. 0.61 ± 0.77, p = 0.200). Logistic regression analysis showed that among several factors that could affect recurrence rate of VH, only range of photocoagulation performed was a statistically significant factor (odds ratio, 0.119; 95% confidence interval, 0.022-0.659; p = 0.015). CONCLUSIONS: Photocoagulation treatment over a wider range with scleral indentation could be a beneficial adjunct procedure for preventing postoperative recurrent VH following diabetic vitrectomy.
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Diabetes Mellitus , Retinopatía Diabética , Humanos , Vitrectomía/métodos , Hemorragia Vítrea/diagnóstico , Hemorragia Vítrea/prevención & control , Hemorragia Vítrea/cirugía , Estudios Retrospectivos , Retina , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/cirugía , Retinopatía Diabética/complicaciones , Fotocoagulación/efectos adversosRESUMEN
BACKGROUND: Biologic agents are emerging as an important treatment option for immune-mediated diseases. Injection site reactions following subcutaneous injection of biologic agents is not well described in the literature. OBJECTIVE: To summarize injection site reaction data in phase 3 trials of all biologic agents. METHODS: MEDLINE, Embase, and CENTRAL databases were systematically searched on February 8, 2022. Proportional meta-analysis was conducted to summarize injection site reaction prevalence for each biologic. RESULTS: There were 158 articles included in the review. The most common types of injection site reactions were erythema (42.8%), unspecified reaction (23.3%), pain (12.4%), and pruritus (5.7%). No patients discontinued their treatment due to injection site reactions in 39 of the 48 studies that reported on discontinuation data. There were 16 biologics included in meta-analysis across 80 eligible studies. The biologics with the highest point prevalence of patients reporting injection site reactions were Canakinumab (15.5%; 294 patients), Dupilumab (11.4%; 1888 patients), Etanercept (11.4%; 4363 patients), and Ixekizumab (11.2%; 2205 patients). The biologics with the lowest point prevalence of injection site reactions were Risankizumab (0.8%; 707 patients), Brodalumab (1.3%; 1365 patients), Guselkumab (1.3%; 1852 patients), Secukinumab (1.9%; 1277 patients). CONCLUSIONS: The prevalence of injection site reaction in response to biologics ranges from 0.08 to 15.5%. Canakinumab, Dupilumab, Etanercept, and Ixekizumab had the highest prevalence of injection site reactions. Risankizumab, Brodalumab, Guselkumab, and Secukinumab had the lowest prevalence of injection site reactions. Recommendations are made regarding the improvement of adverse event reporting to better understand the epidemiology of injection site reactions.
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Productos Biológicos , Psoriasis , Humanos , Etanercept/efectos adversos , Reacción en el Punto de Inyección/epidemiología , Reacción en el Punto de Inyección/etiología , Factores Biológicos , Productos Biológicos/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Nodding syndrome is a neurological disease of children in northern Uganda. Infection with the nematode parasite Onchocerca volvulus has been epidemiologically implicated as the cause of the disease. It has been proposed that an autoantibody directed against the human protein leiomodin-1 cross reacts with a tropomyosin-like nematode protein, thus suggesting that nodding syndrome is an autoimmune brain disease due to extra-cerebral parasitism. This hypothesis is dependent on constitutive neuronal expression of leiomodin-1. We tested this hypothesis by studying the distribution of leiomodin-1 in the normal human brain and other human tissues using immunohistochemistry. We found that immunostaining for leiomodin-1 follows a smooth muscle cell specific pattern. In the brain, it is confined to the smooth muscle cells of cerebral blood vessels and is not generally present in neurons or glia. However, immunoreactivity was identified in human Purkinje cell membrane and the body wall of C. elegans (as a proxy for Onchocerca volvulus) but only when immunostained with an antibody recognizing the N-terminal of leiomodin-1. Homology between leiomodin-1 and tropomodulin, specifically at the N-terminus, could explain why leiomodin-1 antibody cross reactivity between human Purkinje cells and C. elegans. However, we cannot provide proof confirming that the immunoreactivity in the membranes of Purkinje cells is specifically caused by the expression of tropomodulin. To overcome this limitation, further investigations using additional immunohistochemical and biochemical studies are required to corroborate our findings and provide more comprehensive evidence. Nevertheless, our findings do not support to the autoimmunity hypothesis involving Onchocerca volvulus and leiomodin-1. To gain a more comprehensive understanding of the cause and pathogenesis of NS, it is essential to explore alternative hypotheses.
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BACKGROUND: Patient-reported outcome measures (PROMs) quantify patient perspectives to measure outcomes that matter to patients. The aim of this study was to assess the reporting of appropriateness and quality of PROM selection in plastic surgery randomized controlled trials (RCTs). METHODS: MEDLINE, Embase, and CENTRAL were searched from January 1, 2000, to June 5, 2022, to identify published RCTs within the plastic surgery literature. Included studies were categorized as follows: 1) a clearly defined patient-reported primary outcome; 2) a primary outcome could be inferred; or 3) no clear or implied primary outcome. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) database was consulted to assess the available literature on the PROMs. RESULTS: There were 130 plastic surgery RCTs identified. Of the 43 studies with a clear or inferred primary outcome, the percentage of studies that commented with supporting references on the PROM's appropriateness for the population, disease/condition, and outcome were 20.9% (n = 9/43), 18.6% (n = 8/43), and 27.9% (n = 12/43), respectively. The percentage of studies that commented on the PROM's validity, reliability, and responsiveness with supporting references were 34.9% (n = 15/43), 14.0% (n = 6/43), and 11.7% (n = 5/43), respectively. There were 21 unique PROMs identified; 28.6% (n = 6/21) were available in the COSMIN database. CONCLUSION: The majority of plastic surgery RCTs assessing patient-reported primary outcomes lack transparency surrounding PROM selection and quality. We recommend investigators conducting plastic surgery clinical research report explicitly why they used a particular PROM and support its appropriateness and psychometric properties with supporting references. Finally, they should familiarize themselves with the COSMIN initiative.
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Procedimientos de Cirugía Plástica , Cirugía Plástica , Humanos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Resultados Informados por el PacienteRESUMEN
Kidney grafts are the most common transplanted solid organ. To optimize graft survival, radiologists should be familiar with the anatomy and potential complications unique to transplanted kidneys. In addition to being able to recognize the imaging characteristics to diagnose etiologies of kidney graft dysfunction, an understanding of the pathophysiology is a key to narrowing the differential diagnosis. This article provides a summary of the most common complications based on broad categories of type of complication and posttransplant timing.
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Trasplante de Riñón , Humanos , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/métodos , Riñón , Supervivencia de Injerto , Complicaciones Posoperatorias/diagnóstico por imagenRESUMEN
The deep inferior epigastric artery perforator (DIEP) flap is widely used in autologous breast reconstruction. However, the technique relies heavily on nonrandomized observational research, which has been found to have high risk of bias. "Spin" can be used to inappropriately present study findings to exaggerate benefits or minimize harms. The primary objective was to assess the prevalence of spin in nonrandomized observational studies on DIEP reconstruction. The secondary objectives were to determine the prevalence of each spin category and strategy. Methods: MEDLINE and Embase databases were searched from January 1, 2015, to November 15, 2022. Spin was assessed in abstracts and full-texts of included studies according to criteria proposed by Lazarus et al. Results: There were 77 studies included for review. The overall prevalence of spin was 87.0%. Studies used a median of two spin strategies (interquartile range: 1-3). The most common strategies identified were causal language or claims (n = 41/77, 53.2%), inadequate extrapolation to larger population, intervention, or outcome (n = 27/77, 35.1%), inadequate implication for clinical practice (n = 25/77, 32.5%), use of linguistic spin (n = 22/77, 28.6%), and no consideration of the limitations (n = 21/77, 27.3%). There were no significant associations between selected study characteristics and the presence of spin. Conclusions: The prevalence of spin is high in nonrandomized observational studies on DIEP reconstruction. Causal language or claims are the most common strategy. Investigators, reviewers, and readers should familiarize themselves with spin strategies to avoid misinterpretation of research in DIEP reconstruction.
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Engineering of solid electrolytes of Li-ion batteries is carried out for achieving high levels of ionic conductivity and preserving low levels of electrical conductivity. Doping metallic elements into solid electrolyte materials composed of Li, P, and O is quite challenging due to instances of possible decomposition and secondary phase formation. To accelerate the development of high-performance solid electrolytes, predictions of thermodynamic phase stabilities and conductivities are necessary, as they would avoid the need to carry out exhaustive trial-and-error experiments. In this study, we demonstrated theoretical approach to increase the ionic conductivity of amorphous solid electrolyte by doping: cell volume-ionic conductivity relation. Using density functional theory (DFT) calculations, we examined the validity of the hypothetical principle in predicting improvements in stability and ionic conductivity with 6 candidate doping elements (Si, Ti, Sn, Zr, Ce, Ge) in a quaternary Li-P-O-N solid electrolyte system (LiPON) both in crystalline and amorphous phases. The doping of Si into LiPON (Si-LiPON) was indicated to stabilize the system and enhance ionic conductivity based on our calculated doping formation energy and cell volume change. The proposed doping strategies provide crucial guidelines for the development of solid-state electrolytes with enhanced electrochemical performances.
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BACKGROUND: The FACE-Q Aesthetics module is a validated patient-reported outcome measure (PROM) that evaluates perspectives on facial aesthetic treatments. Improper administration and poor study methodology can compromise the validity and interpretation of this PROM. OBJECTIVES: This systematic review sought to evaluate the administration and scoring of the FACE-Q Aesthetics scales within the literature. METHODS: A search of Ovid Medline, Embase, Cochrane, and Web of Science was performed on December 20, 2022, with the assistance of a health-research librarian (CRD42022383676). Studies that examined facial aesthetic interventions using the FACE-Q Aesthetics module as a primary or secondary outcome measure were included for analysis. RESULTS: There were 114 studies included. The Face Overall (n = 52, 45.6%), Psychological (n = 45, 39.4%), and Social (n = 43, 37.7%) scales were most frequently reported. Errors in FACE-Q administration were identified in 30 (26.3%) studies. The most common error was the presentation of raw ordinal scores rather than the converted Q score (n = 23). Most studies reported a time horizon for their primary analysis (n = 76, 66.7%); however, only 4 studies provided a rationale for this selection. Sample size calculations for the primary outcome were rarely performed (n = 9, 7.9%). CONCLUSIONS: There continues to be limitations in PROM administration and the quality of articles that report FACE-Q Aesthetic scale data. The authors suggest that future investigators using the FACE-Q refer to the User's Guide regarding administration and scoring of this scale, report a rationale for the study time horizon, and provide an a priori sample size calculation for the primary outcome of interest.
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Calidad de Vida , Humanos , Estética , PsicometríaRESUMEN
OBJECTIVE: To identify cases and summarize outcomes of cutaneous malignancies in patients with epidermolysis bullosa (EB). DATA SOURCES: MEDLINE and EMBASE databases were searched on February 8, 2022. STUDY SELECTION: Original observational or experimental studies with cases of cutaneous malignancy in patients with inherited EB were included. DATA EXTRACTION: Data were extracted by two reviewers in duplicate. DATA SYNTHESIS: A total of 87 articles with 367 patients were included in this systematic review. Squamous cell carcinomas were the most common malignancy (94.3%) with a median survival of 60 months. The presence of metastasis was investigated at diagnosis in 77 patients; 18.8% of patients had detectable metastasis. Patients with squamous cell carcinoma with metastasis at diagnosis had significantly shorter median survival (16.8 months) than those without (72 months; P = .027). The remission rate was 47.6%. At the end of follow-up, 15.1% were alive with disease, and 41.6% were deceased. Other malignancies included malignant melanoma and basal cell carcinoma. The most common initial modes of management were excisions (71.9%) and amputations (17.6%). Other modes included chemotherapy (4.6%), radiation (3.9%), and no treatment (2.6%). The overall rate of recurrence or new lesions was 38.8%, with a median time of 16 months to recurrence or new lesions. Immediate recurrence was lowest following amputation (4.3%). There were no statistically significant differences in median survival among initial excision, amputation, and all other modes combined ( P = .30). CONCLUSIONS: Squamous cell carcinomas in patients with EB have a high likelihood of metastasis and mortality. Surgical excision is the most common intervention. There are no significant differences in survival among different initial management options. There is a need for research that documents and monitors outcomes of the treatment options.
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Carcinoma Basocelular , Carcinoma de Células Escamosas , Epidermólisis Ampollosa , Melanoma , Neoplasias Cutáneas , Humanos , Neoplasias Cutáneas/terapia , Neoplasias Cutáneas/patología , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/patología , Epidermólisis Ampollosa/complicaciones , Epidermólisis Ampollosa/terapia , Epidermólisis Ampollosa/patologíaRESUMEN
BRIEF ABSTRACT: This is a protocol to assess feasibility of conducting a prospective cohort study comparing local flaps versus skin grafts for surgical excision of skin cancer from the face. INTRODUCTION: Skin cancer is the most common malignancy worldwide and the face is one of the most common locations of occurrence. Surgical excision is the most popular treatment for small lesions of the face. Defects can be reconstructed using local flaps or skin grafts. There is a paucity of literature evaluating outcomes after skin cancer surgery from the patient's perspective using valid measurement tools. The purpose of this study is to assess the feasibility of conducting a prospective observational cohort study. The primary outcomes include recruitment rates, eligibility rate, compliance of intervention and rate of completion of the primary outcome (FACE-Q scales) at 3 months. Secondary outcomes include examining patient characteristic and FACE-Q score differences between local flaps to skin grafts and adverse events. METHODS AND ANALYSIS: This study is a prospective cohort study consisting of an anticipated 30 patients aged ≥18 years. The study population will consist of a consecutive sample of non-melanoma facial skin cancer patients undergoing a skin graft or local flap. Patients will be followed and evaluated with the FACE-Q questionnaire at 2 weeks, 3 months, 6 months and 1 year post-operation. The following criteria will determine success: patients who meet eligibility criteria >70%; recruitment rate >70%; compliance with intervention >90%; rate of completion of full-scale prospective study primary outcome (FACE-Q at 3 months) >80%; retention rate at 6-month follow-up visit >70%. DISCUSSION: The findings of this study will be used to guide the sample size calculation for a future, large-scale prospective study.Trial registration: ClinicalTrials.gov (NCT04842279).
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Neoplasias Cutáneas , Trasplante de Piel , Humanos , Adolescente , Adulto , Estudios Prospectivos , Estudios de Factibilidad , Colgajos Quirúrgicos/cirugía , Neoplasias Cutáneas/cirugía , Estudios Observacionales como AsuntoRESUMEN
PURPOSE: While anterior cervical discectomy and fusion as well as cervical disk arthroplasty are gold standard treatments for the surgical treatment of cervical radiculopathy, posterior endoscopic cervical foraminotomy (PECF) as a substitute procedure is gaining popularity. To date, studies investigating the number of surgeries needed to achieve proficiency in this procedure are lacking. The purpose of the study is to examine the learning curve for PECF. METHODS: The learning curve in operative time for two fellowship-trained spine surgeons at independent institutions was retrospectively assessed for 90 uniportal PECF procedures (PBD: n = 26, CPH: n = 64) performed from 2015 to 2022. Operative time was assessed across consecutive cases using a nonparametric monotone regression, and a plateau in operative time was used as a proxy to define the learning curve. Secondary outcomes assessing achievement of endoscopic prowess before and after the initial learning curve included number of fluoroscopy images, visual analog scale (VAS) for neck and arm, Neck Disability Index (NDI), and the need for reoperation. RESULTS: There was no significant difference in operative time between surgeons (p = 0.420). The start of a plateau for Surgeon 1 occurred at 9 cases and 111.6 min. The start of a plateau for Surgeon 2 occurred at 29 cases and 114.7 min. A second plateau for Surgeon 2 occurred at 49 cases and 91.8 min. Fluoroscopy use did not significantly change before and after surmounting the learning curve. The majority of patients achieved minimally clinically important differences in VAS and NDI after PECF, but postoperative VAS and NDI did not significantly differ before and after achieving the learning curve. There were no significant differences in revisions or postoperative cervical injections before and after reaching a steady state in the learning curve. CONCLUSION: PECF is an advanced endoscopic technique with an initial improvement in operative time that occurred after as few as 8 cases to as many as 28 cases in this series. A second learning curve may occur with additional cases. Patient-reported outcomes improve following surgery, and these outcomes are independent of the surgeon's position on the learning curve. Fluoroscopy use does not change significantly along the learning curve. PECF is a safe and effective technique that current and future spine surgeons should consider as part of their armamentarium.