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OBJECTIVES: Although research has continued to show that substance use disorders (SUDs) can be treated effectively with evidence-based treatment, there continues to be gaps in access, and utilization remains low. Alternative SUD treatment methods, including telemedicine, are increasingly being explored to reach patients where traditional in-person treatment approaches are inaccessible. This cross-sectional study aimed to explore SUD treatment retention, specifically comparing telemedicine-delivered opioid use disorder (OUD) treatment with a traditional in-person treatment delivery approach. METHODS: Patients at Cahaba Medical Care, an FQHC in Birmingham, AL with a diagnosis of OUD and undergoing buprenorphine/naloxone or buprenorphine treatment were categorized into two groups: treatment and control. The dependent variable, retention to SUD treatment, was assessed at four different time periods over 12 months to determine patient SUD consultation appointment attendance. Multiple linear regression was used to examine the relationship between SUD treatment retention and delivery mode. Correlations were obtained to assess associations between frequency of urine drug screens performed and SUD treatment retention. RESULTS: As the number of the urine drug screens patients received increased by 1, the number of SUD treatment program consultations patients attended increased by 0.69 (P < 0.001). There was no significant difference in SUD treatment retention between traditional in-person and telemedicine delivered approaches, however. CONCLUSIONS: The findings of this study suggest that a telemedicine-delivered treatment program equals retention effectiveness when compared with in-person delivery. This suggests that leveraging telemedicine to treat patients with SUD could be an effective alternative for those unable to access treatment or who are less likely to attend or complete traditional in-person treatment sessions.
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Transtornos Relacionados ao Uso de Opioides , Telemedicina , Humanos , Telemedicina/estatística & dados numéricos , Estudos Transversais , Masculino , Feminino , Adulto , Transtornos Relacionados ao Uso de Opioides/terapia , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Pessoa de Meia-Idade , Tratamento de Substituição de Opiáceos/métodos , Tratamento de Substituição de Opiáceos/estatística & dados numéricos , Transtornos Relacionados ao Uso de Substâncias/terapia , Retenção nos Cuidados/estatística & dados numéricos , Buprenorfina/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Combinação Buprenorfina e Naloxona/uso terapêuticoRESUMO
Locally recurrent nasopharyngeal carcinoma (NPC) presents substantial challenges in clinical management. Although postoperative re-irradiation (re-RT) has been acknowledged as a potential treatment option, standardized guidelines and consensus regarding the use of re-RT in this context are lacking. This article provides a comprehensive review and summary of international recommendations on postoperative management for potentially resectable locally recurrent NPC, with a special focus on postoperative re-RT. A thorough search was conducted to identify relevant studies on postoperative re-RT for locally recurrent NPC. Controversial issues, including resectability criteria, margin assessment, indications for postoperative re-RT, and the optimal dose and method of re-RT, were addressed through a Delphi consensus process. The consensus recommendations emphasize the need for a clearer and broader definition of resectability, highlighting the importance of achieving clear surgical margins, preferably through an en bloc approach with frozen section margin assessment. Furthermore, these guidelines suggest considering re-RT for patients with positive or close margins. Optimal postoperative re-RT doses typically range around 60 Gy, and hyperfractionation has shown promise in reducing toxicity. These guidelines aim to assist clinicians in making evidence-based decisions and improving patient outcomes in the management of potentially resectable locally recurrent NPC. By addressing key areas of controversy and providing recommendations on resectability, margin assessment, and re-RT parameters, these guidelines serve as a valuable resource for clinical experts involved in the treatment of locally recurrent NPC.
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PURPOSE: Merkel cell carcinoma (MCC) is an aggressive skin cancer with a 40% recurrence rate, lacking effective prognostic biomarkers and surveillance methods. This prospective, multicenter, observational study aimed to evaluate circulating tumor DNA (ctDNA) as a biomarker for detecting MCC recurrence. METHODS: Plasma samples, clinical data, and imaging results were collected from 319 patients. A tumor-informed ctDNA assay was used for analysis. Patients were divided into discovery (167 patients) and validation (152 patients) cohorts. Diagnostic performance, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), was assessed. RESULTS: ctDNA showed high sensitivity, 95% (discovery; 95% CI, 87 to 99) and 94% (validation; 95% CI, 85 to 98), for detecting disease at enrollment, with corresponding specificities of 90% (95% CI, 82 to 95) and 86% (95% CI, 77 to 93). A positive ctDNA during surveillance indicated increased recurrence risk, with hazard ratios (HRs) of 6.8 (discovery; 95% CI, 2.9 to 16) and 20 (validation; 95% CI, 8.3 to 50). The PPV for clinical recurrence at 1 year after a positive ctDNA test was 69% (discovery; 95% CI, 32 to 91) and 94% (validation; 95% CI, 71 to 100), respectively. The NPV at 135 days after a negative ctDNA test was 94% (discovery; 95% CI, 90 to 97) and 93% (validation; 95% CI, 89 to 97), respectively. Patients positive for ctDNA within 4 months after treatment had higher rates of recurrence, with 1-year rates of 74% versus 21% (adjusted HR, 7.4 [95% CI, 2.7 to 20]). CONCLUSION: ctDNA testing exhibited high prognostic accuracy in detecting MCC recurrence, suggesting its potential to reduce frequent surveillance imaging. ctDNA also identifies high-risk patients who need more frequent imaging and may be best suited for adjuvant therapy trials.
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BACKGROUND: The semantics of entities extracted from a clinical text can be dramatically altered by modifiers, including entity negation, uncertainty, conditionality, severity, and subject. Existing models for determining modifiers of clinical entities involve regular expression or features weights that are trained independently for each modifier. METHODS: We develop and evaluate a multi-task transformer architecture design where modifiers are learned and predicted jointly using the publicly available SemEval 2015 Task 14 corpus and a new Opioid Use Disorder (OUD) data set that contains modifiers shared with SemEval as well as novel modifiers specific for OUD. We evaluate the effectiveness of our multi-task learning approach versus previously published systems and assess the feasibility of transfer learning for clinical entity modifiers when only a portion of clinical modifiers are shared. RESULTS: Our approach achieved state-of-the-art results on the ShARe corpus from SemEval 2015 Task 14, showing an increase of 1.1% on weighted accuracy, 1.7% on unweighted accuracy, and 10% on micro F1 scores. CONCLUSIONS: We show that learned weights from our shared model can be effectively transferred to a new partially matched data set, validating the use of transfer learning for clinical text modifiers.
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Transtornos Relacionados ao Uso de Opioides , Humanos , Aprendizado de Máquina , Semântica , Processamento de Linguagem NaturalRESUMO
Detection of extranodal extension on histopathology in surgically treated head and neck squamous cell carcinoma indicates poor prognosis. However, there is no consensus on the diagnostic criteria, interpretation, and reporting of histology detected extranodal extension, which has contributed to conflicting evidence in the literature, and likely clinical inconsistency. The Head and Neck Cancer International Group conducted a three-round modified Delphi process with a group of 19 international pathology experts representing 15 national clinical research groups to generate consensus recommendations for histology detected extranodal extension diagnostic criteria. The expert panel strongly agreed on terminology and diagnostic features for histology detected extranodal extension and soft tissue metastasis. Moreover, the panel reached consensus on reporting of histology detected extranodal extension and on nodal sampling. These consensus recommendations, endorsed by 19 organisations representing 34 countries, are a crucial development towards standardised diagnosis and reporting of histology detected extranodal extension, and more accurate data collection and analysis.
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Consenso , Técnica Delphi , Extensão Extranodal , Neoplasias de Cabeça e Pescoço , Humanos , Neoplasias de Cabeça e Pescoço/patologia , Extensão Extranodal/patologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Terminologia como AssuntoRESUMO
Extranodal extension of tumour on histopathology is known to be a negative prognostic factor in head and neck cancer. Compelling evidence suggests that extranodal extension detected on radiological imaging is also a negative prognostic factor. Furthermore, if imaging detected extranodal extension could be identified reliably before the start of treatment, it could be used to guide treatment selection, as patients might be better managed with non-surgical approaches to avoid the toxicity and cost of trimodality therapy (surgery, chemotherapy, and radiotherapy together). There are many aspects of imaging detected extranodal extension that remain unresolved or are without consensus, such as the criteria to best diagnose them and the associated terminology. The Head and Neck Cancer International Group conducted a five-round modified Delphi process with a group of 18 international radiology experts, representing 14 national clinical research groups. We generated consensus recommendations on the terminology and diagnostic criteria for imaging detected extranodal extension to harmonise clinical practice and research. These recommendations have been endorsed by 19 national and international organisations, representing 34 countries. We propose a new classification system to aid diagnosis, which was supported by most of the participating experts over existing systems, and which will require validation in the future. Additionally, we have created an online educational resource for grading imaging detected extranodal extensions.
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Consenso , Extensão Extranodal , Neoplasias de Cabeça e Pescoço , Humanos , Neoplasias de Cabeça e Pescoço/diagnóstico por imagem , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/terapia , Extensão Extranodal/diagnóstico por imagem , Extensão Extranodal/patologia , Técnica Delphi , Terminologia como Assunto , PrognósticoRESUMO
Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.
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Consenso , Determinação de Ponto Final , Neoplasias de Cabeça e Pescoço , Carcinoma de Células Escamosas de Cabeça e Pescoço , Humanos , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/terapia , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/mortalidade , Determinação de Ponto Final/normas , Ensaios Clínicos Fase III como Assunto , Intervalo Livre de ProgressãoRESUMO
Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.
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Consenso , Determinação de Ponto Final , Neoplasias de Cabeça e Pescoço , Recidiva Local de Neoplasia , Carcinoma de Células Escamosas de Cabeça e Pescoço , Humanos , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Carcinoma de Células Escamosas de Cabeça e Pescoço/secundário , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Recidiva Local de Neoplasia/patologia , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/terapia , Determinação de Ponto Final/normas , Ensaios Clínicos Fase III como Assunto , Metástase NeoplásicaRESUMO
PURPOSE: Adjuvant radiation therapy (ART) for cutaneous squamous cell carcinoma is recommended based on a number of wide-ranging clinicopathologic features, which encompass a broad array of patients. The 40-gene expression profile (GEP) test classifies cutaneous squamous cell carcinoma tumors into low (class 1), higher (class 2A), or highest (class 2B) risk of nodal and/or distant metastasis. This study's hypotheses are as follows: (1) local recurrence is associated with metastatic disease progression and (2) 40-GEP, by identifying high risk for metastasis, could predict a metastasis-specific benefit from ART. METHODS AND MATERIALS: Samples were obtained from 920 patients (ART-untreated: 496 class 1, 335 class 2A, and 33 class 2B; ART-treated: 11 class 1, 35 class 2A, and 10 class 2B) who were matched on clinical risk factors and stratified by ART status to create 49 matched patient strata. To control for the variety of characteristics and treatment selection bias, randomly sampled pairs of matched ART and non-ART patients comprising 10,000 resampled cohorts were each analyzed for 5-year metastasis-free survival and predicted time to metastatic event. RESULTS: Of 96 patients experiencing local recurrence, 56.3% experienced metastasis; of those experiencing both, 88.9% experienced local recurrence before (75.9%) or concurrently (13.0%) with metastasis. After matching for clinicopathologic risk, median 5-year disease progression rates for resampled cohorts demonstrated approximately 50% improvement for class 2B ART-treated compared with ART-untreated cohorts. ART-treated class 2B cohorts had a 5-fold delay in predicted time to metastatic event and deceleration of disease progression compared with ART-untreated cohorts (Kolmogorov-Smirnov test, P < .01); this was not observed for patients with class 1 or 2A cSCC (P > .05 for each). No risk factor or staging system combined with ART status identified groups that would benefit from ART as well as 40-GEP. CONCLUSIONS: Forty-GEP identifies patients at the highest risk of nodal/distant metastasis who may derive the greatest benefit from ART, as well as patients who may have clinical indications for ART but are at low risk of metastasis. Compared with current guidelines, 40-GEP could provide greater specificity concerning the benefit of ART in individual patients.
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BACKGROUND: The health-care industry is a substantial contributor to global greenhouse gas emissions, yet the specific environmental impact of radiotherapy, a cornerstone of cancer treatment, remains under-explored. We aimed to quantify the emissions associated with the delivery of radiotherapy in the USA and propose a framework for reducing the environmental impact of oncology care. METHODS: In this multi-institutional retrospective analysis and simulation study, we conducted a lifecycle assessment of external beam radiotherapy (EBRT) for ten anatomical disease sites, adhering to the International Organization for Standardization's standards ISO 14040 and ISO 14044. We analysed retrospective data from Jan 1, 2017, to Oct 1, 2023, encompassing patient and staff travel, medical supplies, and equipment and building energy use associated with the use of EBRT at four academic institutions in the USA. The primary objective was to measure the environmental impacts across ten categories: greenhouse gases (expressed as kg of carbon dioxide equivalents [CO2e]), ozone depletion, smog formation, acidification, eutrophication, carcinogenic and non-carcinogenic potential, respiratory effects, fossil fuel depletion, and ecotoxicity. Human health effects secondary to these environmental impacts were also estimated as disability-adjusted life years. We also assessed the potential benefits of hypofractionated regimens for breast and genitourinary (ie, prostate and bladder) cancers on US greenhouse gas emissions using an analytic model based on the 2014 US National Cancer Database for fractionation patterns and patient commute distances. FINDINGS: We estimated that the mean greenhouse gas emissions associated with a standard 25-fraction EBRT course were 4310 kg CO2e (SD 2910), which corresponded to 0·0035 disability-adjusted life years per treatment course. Transit and building energy usage accounted for 25·73% (1110 kg CO2e) and 73·95% of (3190 kg CO2e) of total greenhouse gas emissions, respectively, whereas supplies contributed only 0·32% (14 kg CO2e). Across the other environmental impact categories, most of the environmental impact also stemmed from patient transit and energy use within facilities, with little environmental impact contributed by supplies used. Hypofractionated treatment simulations suggested a substantial reduction in greenhouse gas emissions-by up to 42% for breast and 77% for genitourinary cancer-and environmental impacts more broadly. INTERPRETATION: This comprehensive lifecycle assessment of EBRT delineates the environmental and secondary health impacts of radiotherapy, and underscores the urgent need for sustainable practices in oncology. The findings serve as a reference for future decarbonisation efforts in cancer care and show the potential environmental benefits of modifying treatment protocols (when clinical equipoise exists). They also highlight strategic opportunities to mitigate the ecological footprint in an era of escalating climate change and increasing cancer prevalence. FUNDING: Mount Zion Health Fund.
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Neoplasias , Humanos , Estudos Retrospectivos , Neoplasias/radioterapia , Estados Unidos , Gases de Efeito Estufa/efeitos adversos , Gases de Efeito Estufa/análise , Radioterapia/efeitos adversos , Meio Ambiente , Simulação por ComputadorRESUMO
The MD Anderson Dysphagia Inventory (MDADI), a measure of swallowing-related quality of life, has become the preferred patient-reported outcome measure (PROM) in contemporary clinical trials evaluating the experience of human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPVOPSCC) survivors. With many potentially practice-changing studies using the MDADI composite score as either a primary or coprimary endpoint, or as a key secondary endpoint, it is important to understand its psychometric properties as judged by contemporary PROM standards, with a particular focus on its application to contemporary HPVOPSCC populations. In this critical review, we evaluate contemporary HPVOPSCC studies reporting MDADI outcomes, followed by a detailed evaluation of the psychometric properties of the MDADI. Although the focus of this review was the MDADI, the issues discussed are not unique to the MDADI and have broader applicability to the evaluation and assessment of other PROMs currently in use. First, it may be possible to improve administration of the instrument, as related to missing items, scoring, and the number of items required. Second, although in many instances, the MDADI has been intended as a direct or surrogate measure of swallowing physiology, the MDADI composite score captures a broader health-related quality of life construct affected by both swallowing and eating, the latter of which may be affected by a range of nonswallowing treatment-related toxicities. Finally, a clinically meaningful change of 10 in the MDADI composite score, widely accepted and applied to the clinical trial setting, represents an undoubtably clinically relevant difference in unselected head and neck cancer survivors. However, the smallest difference that might be clinically important to a highly functional HPVOPSCC cohort remains uncertain. Understanding the purpose and properties of the MDADI instrument and furthering the sophistication with which we apply it in this population would improve its interpretation in clinical trials.
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Fibroblast activation protein (FAP), expressed in the tumor microenvironment of a variety of cancers, has become a target of novel PET tracers. The purpose of this report is to evaluate the imaging characteristics of 68Ga-FAP-2286, present the first-to our knowledge-dosimetry analysis to date, and compare the agent with 18F-FDG and FAPI compounds. Methods: Patients were administered 219 ± 43 MBq of 68Ga-FAP-2286 and scanned after 60 min. Uptake was measured in up to 5 lesions per patient and within the kidneys, spleen, liver, and mediastinum (blood pool). Absorbed doses were evaluated using MIM Encore and OLINDA/EXM version 1.1 using the International Commission on Radiological Protection publication 103 tissue weighting factor. Results: Forty-six patients were imaged with 68Ga-FAP-2286 PET. The highest average uptake was seen in sarcoma, cholangiocarcinoma, and colon cancer. The lowest uptake was found in lung cancer and testicular cancer. The average SUVmax was significantly higher on 68Ga-FAP-2286 PET than on 18F-FDG PET in cholangiocarcinoma (18.2 ± 6.4 vs. 9.1 ± 5.0, P = 0.007), breast cancer (11.1 ± 6.8 vs. 4.1 ± 2.2, P < 0.001), colon cancer (13.8 ± 2.2 vs. 7.6 ± 1.7, P = 0.001), hepatocellular carcinoma (9.3 ± 3.5 vs. 4.7 ± 1.3, P = 0.01), head and neck cancer (11.3 ± 3.5 vs. 7.6 ± 5.5, P = 0.04), and pancreatic adenocarcinoma (7.4 ± 1.8 vs. 3.7 ± 1.0, P = 0.01). The total-body effective dose was estimated at 1.16E-02 mSv/MBq, with the greatest absorbed organ dose in the urinary bladder wall (9.98E-02 mGy/MBq). Conclusion: 68Ga-FAP-2286 biodistribution, dosimetry, and tumor uptake were similar to those of previously reported FAPI compounds. Additionally,68Ga-FAP-2286 PET had consistently higher uptake than 18F-FDG PET. These results are especially promising in the setting of small-volume disease and differentiating tumor from inflammatory uptake.
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Fluordesoxiglucose F18 , Radioisótopos de Gálio , Neoplasias , Tomografia por Emissão de Pósitrons , Radiometria , Humanos , Fluordesoxiglucose F18/farmacocinética , Masculino , Feminino , Neoplasias/diagnóstico por imagem , Neoplasias/metabolismo , Tomografia por Emissão de Pósitrons/métodos , Pessoa de Meia-Idade , Distribuição Tecidual , Idoso , Adulto , Compostos Radiofarmacêuticos/farmacocinética , Idoso de 80 Anos ou mais , QuinolinasRESUMO
OBJECTIVES: This cross-sectional study aimed to assess the awareness among United States (US) oncologists about oral medicine (OM) as a specialty of dentistry, and their collaboration with OM providers. METHODS: An online survey was conducted, inviting 1350 US oncologists, with data collected on demographics, practice background, comfort level with diagnosing and treating oral conditions, referral practices for oral conditions, and more. RESULTS: Of the invited 1350 oncologists, 192 responded (14% response rate). Among respondents, 46% were familiar with the OM specialty. Of these, 73% had previously sought consultation from OM specialists. The primary reasons for referral included dental clearance before initiating chemotherapy (38.5%), dental clearance before initiating radiotherapy (37%), and managing oral ulcers and oral potentially malignant disorders equally (32.2%). Regarding referrals to providers outside of OM, oncologists primarily referred patients with oral lesions to otolaryngologists (64.6%), followed by oral and maxillofacial surgeons (55.2%) and general dentists (45.3%). CONCLUSION: Our study showed that over half of US oncologists were unfamiliar with the OM specialty. However, the referral rate to OM providers was high among oncologists who had prior OM knowledge. It is advisable to enhance the collaboration between OM and oncology specialists to ensure optimal care for patients with cancer.
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Oncologistas , Medicina Bucal , Encaminhamento e Consulta , Humanos , Estudos Transversais , Estados Unidos , Masculino , Inquéritos e Questionários , Feminino , Encaminhamento e Consulta/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Pessoa de Meia-Idade , Conhecimentos, Atitudes e Prática em Saúde , Competência ClínicaRESUMO
OBJECTIVES: Communication with patients and their families/caregivers to facilitate informed decision making is an integral part of patient/family-centered care. Due to the high coronavirus disease 2019 (COVID-19) infection rates and limited personal protective equipment, healthcare systems were forced to restrict patient visitors, limit patient-provider interactions, and implement other changes in treatment protocols that disturbed traditional communications and risked eroding patient/family-centered care and adversely affected patient satisfaction. This article focuses on changes in patient experience in two dedicated COVID-19 units of an academic medical center located in the US South as a result of the enhanced communication process implemented specifically during the COVID-19 pandemic. METHODS: This retrospective quality improvement project used data from Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys, fielded between January 1, 2021 and August 31, 2021, to understand the role of a proactive communication initiative in patient satisfaction. RESULTS: Our results show that HCAHPS scores for hospital unit hospital unit 4 (HSP4) in all categories increased over time, with the greatest improvements seen in the responsiveness of staff and care transition; however, HCAHPS scores for hospital unit HSP3 remained stable, with a small increase in responsiveness of staff. CONCLUSIONS: Our findings suggest that communication is a critical factor in patient satisfaction, demonstrating the efficacy of a swift and innovative initiative to improve communication with family/caregivers, which may have been linked to better patient experiences. Developing communication strategies is crucial for enhancing patient satisfaction.
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COVID-19 , Pandemias , Humanos , Estudos Retrospectivos , Satisfação do Paciente , Comunicação , COVID-19/epidemiologia , Avaliação de Resultados da Assistência ao Paciente , FamíliaRESUMO
PURPOSE: Locally advanced, unresectable basal cell carcinoma (LA BCC) can be treated with radiation therapy (RT), but locoregional control (LRC) rates are unsatisfactory. Vismodegib is a hedgehog pathway inhibitor (HPI) active in BCC that may radiosensitize BCC. We evaluated the combination of vismodegib and RT for patients with LA BCC. METHODS: In this multicenter, single-arm, phase II study, patients with unresectable LA BCC received 12 weeks of induction vismodegib, followed by 7 weeks of concurrent vismodegib and RT. The primary end point was LRC rate at 1 year after the end of treatment. Secondary end points included objective response, progression-free survival (PFS), overall survival (OS), safety, and patient-reported quality of life (PRQOL). RESULTS: Twenty-four patients received vismodegib; five were unable to complete 12 weeks of induction therapy. LRC was achieved in 91% (95% CI, 68 to 98) of patients at 1 year. The response rate was 63% (95% CI, 38 to 84) after induction vismodegib and 83% (95% CI, 59 to 96) after concurrent vismodegib and RT. With a median follow-up of 5.7 years, 1-year PFS and OS rates were 100% and 96%, and at 5 years PFS and OS rates were 78% and 83%, respectively. Distant metastasis or BCC-related death has not been observed. The most frequent treatment-related adverse events (AEs) were dysgeusia, fatigue, and myalgias occurring in 83%, 75%, and 75% of patients. No grade 4 to 5 treatment-related AEs occurred. PRQOL demonstrated clinically meaningful improvements in all subscales, with emotions and functioning improvements persisting for a year after the end of treatment. CONCLUSION: In patients with unresectable LA BCC, the combination of vismodegib and RT yielded high rates of LRC and PFS and durable improvements in PRQOL.
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Anilidas , Carcinoma Basocelular , Piridinas , Neoplasias Cutâneas , Humanos , Anilidas/uso terapêutico , Anilidas/efeitos adversos , Anilidas/administração & dosagem , Piridinas/uso terapêutico , Piridinas/efeitos adversos , Piridinas/administração & dosagem , Carcinoma Basocelular/patologia , Carcinoma Basocelular/tratamento farmacológico , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/radioterapia , Neoplasias Cutâneas/mortalidade , Idoso de 80 Anos ou mais , Qualidade de Vida , Adulto , Quimiorradioterapia/efeitos adversos , Intervalo Livre de ProgressãoRESUMO
The Head and Neck Cancer International Group (HNCIG) has undertaken an international modified Delphi process to reach consensus on the essential data variables to be included in a minimum database for HNC research. Endorsed by 19 research organisations representing 34 countries, these recommendations provide the framework to facilitate and harmonise data collection and sharing for HNC research. These variables have also been incorporated into a ready to use downloadable HNCIG minimum database, available from the HNCIG website.
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Ensaios Clínicos como Assunto , Consenso , Bases de Dados Factuais , Neoplasias de Cabeça e Pescoço , Humanos , Neoplasias de Cabeça e Pescoço/terapia , Bases de Dados Factuais/normas , Ensaios Clínicos como Assunto/normas , Técnica Delphi , Pesquisa Biomédica/normasRESUMO
BACKGROUND: An international multidisciplinary panel of experts aimed to provide consensus guidelines describing the optimal intratumoral and intranodal injection of NBTXR3 hafnium oxide nanoparticles in head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, and cervical lymph nodes and to review data concerning safety, feasibility, and procedural aspects of administration. METHODS: The Delphi method was used to determine consensus. A 4-member steering committee and a 10-member monitoring committee wrote and revised the guidelines, divided into eight sections. An independent 3-member reading committee reviewed the recommendations. RESULTS: After two rounds of voting, strong consensus was obtained on all recommendations. Intratumoral and intranodal injection was deemed feasible. NBTXR3 volume calculation, choice of patients, preparation and injection procedure, potential side effects, post injection, and post treatment follow-up were described in detail. CONCLUSIONS: Best practices for the injection of NBTXR3 were defined, thus enabling international standardization of intratumoral nanoparticle injection.
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Neoplasias de Cabeça e Pescoço , Injeções Intralesionais , Carcinoma de Células Escamosas de Cabeça e Pescoço , Humanos , Neoplasias de Cabeça e Pescoço/terapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Técnica Delphi , Háfnio/administração & dosagem , Óxidos/administração & dosagem , Nanopartículas/administração & dosagem , Masculino , Consenso , Feminino , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/patologia , Guias de Prática Clínica como AssuntoRESUMO
Nursing homes expressed concern about potential severe adverse financial outcomes of COVID-19, with worries extending to the possibility of some facilities facing closure. Maintaining a strong financial well-being is crucial, and there were concerns that the pandemic might have significantly impacted both expenses and income. This longitudinal study aimed to analyze the financial performance of nursing homes during COVID-19 pandemic. Specifically, we examined the impact of the pandemic on nursing home operating margins, operating revenue per resident day, and operating cost per resident day. The study utilized secondary data from various sources, including CMS Medicare cost reports, Brown University's Long Term Care Focus (LTCFocus), CMS Payroll-Based Journal, CMS Care Compare, Area Health Resource File, Provider Relief Fund distribution data, and CDC's NH COVID-19 public file. The sample consisted of 45 833 nursing home-year observations from 2018 to 2021. Fixed-effects regression analysis was employed to assess the impact of the pandemic on financial performance while controlling for various organizational and market characteristics. The study found that nursing homes' financial performance deteriorated during the COVID-19 pandemic. Operating margins decreased by approximately 4.3%, while operating costs per resident day increased by $26.51, outweighing the increase in operating revenue per resident day by about $17. Occupancy rates, payer mix, and staffing intensity were found to impact financial performance. The study highlights the significant financial impact of the COVID-19 pandemic on nursing homes. While nursing homes faced substantial financial strains, the findings offered lessons for the future, underscoring the need for nursing homes to improve the accuracy of their cost reports and enhance financial transparency and accountability.