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BACKGROUND: Despite improvements in the treatment of primary uveal melanoma (UM), patients with metastatic disease continue to exhibit poor survival. METHODS: A retrospective review of metastatic UM patients at Yale (initial cohort) and Memorial Sloan Kettering (validation cohort) was conducted. Cox proportional hazards regression was used to determine baseline factors that are associated with overall survival, including sex, Eastern Cooperative Oncology Group (ECOG) Performance Status Scale, laboratory measurements, metastasis location, and use of anti-CTLA-4 and anti-PD-1 therapies. Differences in overall survival were analyzed using Kaplan-Meier analysis. RESULTS: A total of 89 patients with metastatic UM were identified; 71 and 18, in the initial and validation cohorts, respectively. In the initial cohort, median follow-up was 19.8 months (range, 2-127 months) and median overall survival was 21.8 months (95% CI, 16.6-31.3). Female sex, anti-CTLA-4, and anti-PD-1 therapy were associated with better survival outcomes with adjusted death hazard ratios (HRs) of 0.40 (95% CI, 0.20-0.78), 0.44 (0.20-0.97), and 0.42 (0.22-0.84), respectively, whereas development of hepatic metastases and ECOG score ≥1 (per 1 U/L) were associated with worse survival outcomes with HRs of 2.86 (1.28-7.13) and 2.84 (1.29-6.09), respectively. In both the initial and validation cohorts, use of immune checkpoint inhibitors was associated with improved overall survival after adjusting for sex and ECOG score, with death HRs of 0.22 (0.08-0.56) and 0.04 (0.002-0.26), respectively. CONCLUSIONS: Development of extrahepatic-only metastases, ECOG of 0, immune checkpoint therapy, and female sex were each associated with more than 2-fold reductions in risk of death. PLAIN LANGUAGE SUMMARY: Metastatic uveal melanoma patients face limited treatment options and poor survival rates. Results from this retrospective analysis indicate that immune checkpoint inhibitors, such as anti-CTLA-4 and anti-PD-1 therapies, were associated with improved survival outcomes. Factors such as extrahepatic-only metastases, better baseline performance status, and female sex contributed to a more than 2-fold reduction in death risk. These findings highlight the potential of immunotherapy in treating metastatic uveal melanoma.
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Melanoma , Neoplasias Uveais , Humanos , Feminino , Ipilimumab/uso terapêutico , Inibidores de Checkpoint Imunológico/uso terapêutico , Estudos Retrospectivos , Melanoma/tratamento farmacológicoRESUMO
PURPOSE: To validate the prognostic usefulness of gene expression profile (GEP) testing in patients with uveal melanoma. To determine whether combining tumor size with the GEP classification provides additional prognostic value. DESIGN: Retrospective analysis. PARTICIPANTS: Patients with a diagnosis of choroidal melanoma examined at Yale New Haven Hospital; University of California, San Diego; and Memorial Sloan Kettering Cancer Center. METHODS: Patients' demographic and clinical data and tumor characteristics were collected. Univariate and multivariate Cox hazard regression analysis were used to assess the association between tumor characteristics and GEP classification with metastasis as an outcome. MAIN OUTCOME MEASURES: Metastasis-free survival (MFS). RESULTS: Of the 337 individuals included in the study, 87 demonstrated metastases. The mean follow-up time was 37.2 (standard deviation [SD], 40.2) months for patients with metastases and 55.0 (SD, 49.3) months for those without metastases. Tumors of larger thickness and GEP class 2 (vs. class 1) were associated significantly with increased risk of metastasis. Tumor thickness showed better prognostic usefulness than GEP classification (Wald statistic, 40.7 and 24.2, respectively). Class 2 tumors with a thickness of 7.0 mm or more were associated with increased risk of metastasis than tumors with a thickness of < 7.0 mm (hazard ratio [HR], 3.23; 95% confidence interval [CI], 1.61-6.51), whereas class 1 tumors with a thickness of 9.0 mm or more were associated with increased risk of metastasis than tumors with a thickness of < 9.0 mm (HR, 2.07; 95% CI, 0.86-4.99). No difference in MFS was found between patients with class 1A tumors compared with those with class 1B tumors (P = 0.8). Patients with class 2 tumors showed an observed 5-year MFS of 47.5% (95% CI, 36.0%-62.8%). CONCLUSIONS: Tumor size was the most significant predictor of metastasis and provided additional prognostic value independent of GEP classification. In addition, rates of metastasis for class 2 tumors were lower than estimates reported by Castle Bioscience, and no difference in rates of metastasis were found between class 1A and 1B tumors. This indicates that tumor size should be accounted for when relying on GEP for prognostication and that patients with GEP class 1A or 1B tumors may benefit from the same metastatic surveillance protocols. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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Melanoma , Neoplasias Uveais , Humanos , Prognóstico , Estudos Retrospectivos , Melanoma/diagnóstico , Melanoma/genética , Melanoma/metabolismo , Neoplasias Uveais/diagnóstico , Neoplasias Uveais/genética , Neoplasias Uveais/patologia , Perfilação da Expressão Gênica/métodosRESUMO
PURPOSE: To determine the effect of playing patient-selected music intraoperatively on patient self-reported anxiety and the amount of sedative administered during cataract surgery. SETTING: Yale New Haven Hospital health system, New Haven, Connecticut. DESIGN: Prospective, randomized, controlled clinical trial. METHODS: Patients were randomized to either a music group or a control group, which had no music played. Patients were blinded to the purpose of the study. On postoperative day 1, patients were consented to participate in the study and asked to complete a 6-question Likert-style survey (modified from the State-Trait Anxiety Inventory) assessing anxiety at baseline and during surgery. Patients' intraoperative and postoperative vitals were recorded. The medication, dosage, and number of sedative injections given were also recorded. Paired t tests were used to assess for significant differences between the 2 groups. RESULTS: 107 patients (mean age 71.2 years) were enrolled in the study. There was no significant difference in baseline anxiety between the 2 groups. Patients randomized to the music group had significantly lower total self-reported anxiety (mean 5.98) than the control group (mean 7.13, P = .006). Moreover, patients exposed to music felt significantly less frightened, nervous, and confused during surgery ( P = .002, .007, and 0.017, respectively). There was no significant difference between the groups in number and dosage of sedatives given. CONCLUSIONS: Playing patient-selected music during cataract surgery is an effective way to decrease anxiety. Music directly affects patient experience and is an inexpensive, low-risk method of reducing patient anxiety during surgery.
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Ansiedade , Musicoterapia , Humanos , Estudos Prospectivos , Idoso , Masculino , Feminino , Ansiedade/prevenção & controle , Musicoterapia/métodos , Facoemulsificação , Implante de Lente Intraocular , Inquéritos e Questionários , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/uso terapêutico , Extração de CatarataRESUMO
BACKGROUND: Patients with prostate cancer tend to be at heightened risk for fracture due to bone metastases and treatment with androgen-deprivation therapy. Bone mineral density (BMD) derived from dual energy X-ray absorptiometry (DXA) is the standard for determining fracture risk in this population. However, BMD often fails to predict many osteoporotic fractures. Patients with prostate cancer also undergo 18F-sodium fluoride (18F-NaF)-positron emission tomography/computed tomography (PET/CT) to monitor metastases. The purpose of this study was to assess whether bone deposition, assessed by 18F-NaF uptake in 18F-NaF PET/CT, could predict incident fractures better than DXA- or CT-derived BMD in patients with prostate cancer. METHODS: This study included 105 males with prostate cancer who had undergone full body 18F-NaF PET/CT. Standardized uptake value (SUVmean and SUVmax) and CT-derived Hounsfield units (HU), a correlate of BMD, were recorded for each vertebral body. The average SUVmean, SUVmax, and HU were calculated for cervical, thoracic, lumbar, and sacral areas. The t-test was used to assess significant differences between fracture and no-fracture groups. RESULTS: The SUVmean and SUVmax values for the thoracic area were lower in the fracture group than in the no-fracture group. There was no significant difference in cervical, thoracic, lumbar or sacral HU between the 2 groups. CONCLUSIONS: Our study reports that lower PET-derived non-metastatic bone deposition in the thoracic spine is correlated with incidence of fractures in patients with prostate cancer. CT-derived HU, a correlate of DXA-derived BMD, was not predictive of fracture risk. 18F-NaF PET/CT may provide important insight into bone quality and fracture risk.
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Patients seeking total joint arthroplasty frequently undergo preoperative optimization with the assistance of nurse navigators to facilitate interactions between patients, consulting services, and the orthopaedic surgical team. Given the enormous impact nurse navigator programs have on reducing postoperative complications, our aim is to characterize the involvement of nurse navigators in preoperative optimization programs across the country. We conducted a survey of nurse navigators identified through the National Association of Orthopaedic Nurses to assess the involvement of nurse navigators in the preoperative optimization process. Sixty-seven percent of responding nurse navigators were involved in preoperative optimization, including components such as heart disease (53%) and poorly controlled diabetes (52%). Orthopaedic nurse navigators are commonly involved in preoperative optimization programs for total joint arthroplasty but most of these involve gated yes/no checklists with limited established referral care pathways. Only some of the programs include standardized referrals for specific medical comorbidities.
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Procedimentos Ortopédicos , Ortopedia , Navegação de Pacientes , Humanos , Inquéritos e Questionários , ArtroplastiaRESUMO
Preoperative optimization of patients seeking total joint arthroplasty is becoming more common, and risk scores, which provide an estimate for the risk of complications following procedures, are often used to assist with the preoperative decision-making process. The aim of this study was to characterize the use of risk scores at institutions that utilize nurse navigators in the preoperative optimization process. The survey included 207 nurse navigators identified via the National Association of Orthopaedic Nurses to better understand the use of risk scores in preoperative optimization and the different factors that are included in these risk scores. The study found that 48% of responding nurse navigators utilized risk scores in the preoperative optimization process. These risk scores often included patient comorbidities such as diabetes (85%) and body mass index (87%). Risk scores are commonly used by nurse navigators in preoperative optimization and involve a variety of comorbidities and patient-specific factors.
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Artroplastia de Quadril , Artroplastia do Joelho , Diabetes Mellitus , Ortopedia , Humanos , Artroplastia de Quadril/efeitos adversos , Fatores de RiscoRESUMO
PURPOSE: To study the epidemiology of all domestic violence (DV)-related ocular injuries among pediatric emergency department (ED) patients in the United States. METHODS: This is a retrospective, cross-sectional study of isolated children (<18 years of age) with a diagnosis of DV and primary or secondary diagnosis of ocular injuries in the Nationwide Emergency Department Sample, 2008-2017. We calculated annual incidence of DV-related ocular injuries and prevalence by demographic variables, including age, sex, and income quartile. Median charges, median length of inpatient hospital stay, and factors associated with hospitalization were also measured. RESULTS: From 2008 to 2017, there were 4,125 ED encounters, with an average incidence of 0.56 per 100,000 population (males, 50.0%; mean age [SE], 9.2 [0.3]). Patients in the lowest income quartile (42.6%) and with Medicaid insurance (63.2%) were the most prevalent. The most common known perpetrator was a family member (29.4%). Most ED encounters took place at southern regional (28.6%), metropolitan teaching (67.1%) and designated trauma hospitals (57.8%). Contusion of the eye/adnexa and being struck by or against an object were the most common ocular diagnosis and known mechanism of injury, respectively. An estimated 12.4% of patients were admitted with a median hospital stay of 4 (IQR, 2-6). Median charges during the study period were $27,415.10 (IQR, $13,142.70-$54,454.90). CONCLUSIONS: DV-related ocular injuries were most prevalent among patients with a low socioeconomic status. Given the historical underreporting of DV, future studies are warranted to identify more specific social determinants of health that contribute to such presentations.
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Violência Doméstica , Traumatismos Oculares , Masculino , Criança , Humanos , Estados Unidos/epidemiologia , Estudos Retrospectivos , Estudos Transversais , Traumatismos Oculares/epidemiologia , Serviço Hospitalar de EmergênciaRESUMO
Preoperative optimization programs are becoming more common for patients seeking total joint arthroplasty; yet, limited research has been conducted to monitor the long-term effects of these programs on patient outcomes. Our aim was to develop a set of metrics that programs can use to monitor the success of preoperative optimization programs. As part of a larger survey of orthopaedic nurses, we collected data regarding current monitoring techniques for preoperative optimization programs and the feasibility of collecting specific variables. Surgical factors such as length of stay and 30-day readmissions were most often used to monitor the success of preoperative optimization programs. Surgical factors were the most likely to be accessible using the electronic medical record. Surgical factors and patient characteristics are the most feasible components for programs to monitor in order to track the outcomes of patients participating in preoperative optimization programs.
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Artroplastia de Quadril , Artroplastia do Joelho , Enfermeiras e Enfermeiros , Ortopedia , Humanos , Artroplastia do Joelho/efeitos adversos , Benchmarking , Artroplastia de Quadril/efeitos adversos , Tempo de Internação , Estudos RetrospectivosRESUMO
Background We previously demonstrated that retinal ischemic perivascular lesions (RIPLs), which are indicative of ischemia in the middle retina, may be a biomarker of ischemic cardiovascular disease. In this study, we sought to determine the relationship between RIPLs and atrial fibrillation, a common source of cardiac emboli. Methods and Results In this case-control study, we identified individuals between the ages of 50 and 90 years who had undergone macular spectral domain optical coherence tomography imaging. Individuals with atrial fibrillation were identified, and age- and sex-matched individuals from the same pool, but without a diagnosis of atrial fibrillation, were selected as controls. Spectral domain optical coherence tomography scans were reviewed by 3 independent and masked observers for presence of RIPLs. The relationship between RIPLs and atrial fibrillation was analyzed using multivariable logistic regression models. There were 106 and 91 subjects with and without atrial fibrillation, respectively. The percentage of subjects with RIPLs was higher in the atrial fibrillation group compared with the control group (57.5% versus 37.4%; P=0.005). After adjusting for age, sex, smoking history, hypertension, diabetes, coronary artery disease, carotid stenosis, stroke, and myocardial infarction, the presence of RIPLs was significantly associated with atrial fibrillation, with an odds ratio of 1.91 (95% CI, 1.01-3.59). Conclusions RIPLs are significantly associated with atrial fibrillation, independent of underlying ischemic heart disease or cardiovascular risk factors. This association may inform the diagnostic cardiovascular workup for individuals with RIPLs incidentally detected on optical coherence tomography scan of the macula.
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Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/complicações , Estudos de Casos e Controles , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Isquemia/complicaçõesRESUMO
BACKGROUND: Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE: The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS: This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS: Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS: Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.