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BACKGROUND: In clinical trials, frontline pembrolizumab for advanced NSCLC has demonstrated durable, clinically meaningful, long-term survival benefits over chemotherapy. Our objective was to evaluate 5-year survival rates outside the idealized setting of clinical trials for advanced/metastatic NSCLC treated with frontline pembrolizumab monotherapy. METHODS: Using a nationwide, electronic health record-derived, deidentified database in the United States, we studied adult patients with advanced/metastatic NSCLC (unresectable stage IIIB/IIIC, or stage IV), with PD-L1 expression ≥ 50%, no documented EGFR, ALK, or ROS1 genomic alteration, and ECOG performance status of 0-1 initiating frontline pembrolizumab monotherapy from November 1, 2016, through March 31, 2020, excluding those in clinical trials. Kaplan-Meier was used to determine overall survival (OS). Data cutoff was May 31, 2023. RESULTS: A total of 804 patients were eligible for the study, including 404 women (50%); median age was 72 years (range, 38-85 years), with 310 patients (39%) ≥ 75 years old. Median follow-up time from pembrolizumab initiation to data cutoff was 60.5 months (range, 38.0-78.7). At data cutoff, 549 patients (68%) had died. Median OS was 19.2 months (95% CI, 16.6-21.4), and survival rate at 5 years was 25.1% (95% CI, 21.7-28.7). Overall, 266 patients (33%) received 1 or more subsequent regimens, most commonly an anti-PD-(L)1 agent (as monotherapy or combination therapy) or platinum-based chemotherapy. CONCLUSIONS: With 5-year follow-up in a real-world population, frontline pembrolizumab monotherapy continues to demonstrate long-term effectiveness, with survival outcomes consistent with those of pivotal clinical trials, for treating patients with advanced NSCLC with PD-L1 expression of ≥ 50% and no EGFR, ALK, or ROS1 genomic alteration.
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Background: Front-line therapy with an EGFR tyrosine kinase inhibitor (TKI) is the standard of care for treating patients with advanced nonsquamous NSCLC with the common sensitizing EGFR exon 19 deletion and exon 21 L858R point mutations. However, EGFR TKI resistance inevitably develops. The optimal subsequent therapy remains to be identified, although platinum-containing chemotherapy regimens are often administered. Our objectives were to describe baseline characteristics, survival, and subsequent treatment patterns for patients with advanced nonsquamous NSCLC with EGFR exon 19 deletion or L858R mutation who received a platinum-based combination regimen after front-line EGFR TKI therapy. Methods: This retrospective study used a nationwide electronic health record-derived deidentified database to select adult patients with advanced nonsquamous NSCLC, evidence of EGFR exon 19 deletion or L858R mutation, and ECOG performance status of 0-2 who initiated platinum-containing chemotherapy, with or without concomitant immunotherapy, from 1-January-2011 to 30-June-2020 following receipt of any EGFR TKI as first-line therapy or, alternatively, a first- or second-generation EGFR TKI (erlotinib, afatinib, gefitinib, dacomitinib) as first-line therapy followed by the third-generation EGFR TKI osimertinib as second-line therapy. Data cut-off was 30-June-2022. The Kaplan-Meier method was used to estimate overall survival (OS) after initiation of pemetrexed-platinum (n=119) or any platinum-based combination regimen (platinum cohort; n=311). Results: The two cohorts included two-thirds women (65%-66%) and 57%-58% nonsmokers; median ages were 66 and 65 years in pemetrexed-platinum and platinum cohorts, respectively. Median OS was 10.3 months (95% CI, 8.1-13.9) from pemetrexed-platinum initiation and 12.4 months (95% CI, 10.2-15.2) from platinum initiation; 12-month survival rates were 48% and 51%, respectively; 260 patients (84%) had died by the end of the study. Conclusion: The suboptimal survival outcomes recorded in this study demonstrate the unmet need to identify more effective subsequent treatment regimens for patients with EGFR-mutated advanced nonsquamous NSCLC after EGFR TKI resistance develops.
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Lindane induces severe side effects, including fatality, while Cetrimide causes esophageal damage. With no antidotes available, our patient ingested both, requiring prompt gastric lavage and comprehensive treatment.
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Introduction: Automated seizure detection promises to aid in the prevention of SUDEP and improve the quality of care by assisting in epilepsy diagnosis and treatment adjustment. Methods: In this phase 2 exploratory study, the performance of a contactless, marker-free, video-based motor seizure detection system is assessed, considering video recordings of patients (age 0-80 years), in terms of sensitivity, specificity, and Receiver Operating Characteristic (ROC) curves, with respect to video-electroencephalographic monitoring (VEM) as the medical gold standard. Detection performances of five categories of motor epileptic seizures (tonic-clonic, hyperkinetic, tonic, unclassified motor, automatisms) and psychogenic non-epileptic seizures (PNES) with a motor behavioral component lasting for >10 s were assessed independently at different detection thresholds (rather than as a categorical classification problem). A total of 230 patients were recruited in the study, of which 334 in-scope (>10 s) motor seizures (out of 1,114 total seizures) were identified by VEM reported from 81 patients. We analyzed both daytime and nocturnal recordings. The control threshold was evaluated at a range of values to compare the sensitivity (n = 81 subjects with seizures) and false detection rate (FDR) (n = all 230 subjects). Results: At optimal thresholds, the performance of seizure groups in terms of sensitivity (CI) and FDR/h (CI): tonic-clonic- 95.2% (82.4, 100%); 0.09 (0.077, 0.103), hyperkinetic- 92.9% (68.5, 98.7%); 0.64 (0.59, 0.69), tonic- 78.3% (64.4, 87.7%); 5.87 (5.51, 6.23), automatism- 86.7% (73.5, 97.7%); 3.34 (3.12, 3.58), unclassified motor seizures- 78% (65.4, 90.4%); 4.81 (4.50, 5.14), and PNES- 97.7% (97.7, 100%); 1.73 (1.61, 1.86). A generic threshold recommended for all motor seizures under study asserted 88% sensitivity and 6.48 FDR/h. Discussion: These results indicate an achievable performance for major motor seizure detection that is clinically applicable for use as a seizure screening solution in diagnostic workflows.
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Background: This study investigated real-world time on treatment (rwToT) and overall survival (OS) for patients with metastatic non-small cell lung cancer (mNSCLC) who initiated first-line (1L) pembrolizumab monotherapy. We also explored discontinuation reasons and subsequent treatments, stratified by number of cycles among those who completed ≥17 cycles of 1L pembrolizumab. Methods: Patients with mNSCLC without actionable genetic aberrations, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 and unknown, and PD-L1 TPS ≥ 50% starting 1L pembrolizumab monotherapy between 24-Oct-2016 and 31-Dec-2018 within The US Oncology Network were identified retrospectively and evaluated using structured data, with a data cutoff of 30-Sep-2021. Patient characteristics and disposition were summarized using descriptive statistics. OS and rwToT were evaluated using Kaplan-Meier method for all ECOG PS and PS 0-1. A subgroup of patients who completed ≥17 cycles were evaluated using supplemental chart review data to discern reasons for discontinuation. Results: Of the 505 patients with mNSCLC with PD-L1 TPS ≥50%, 61% had ECOG PS 0-1, 23% had ECOG PS 2, and 65% had nonsquamous histology. Median rwToT and OS of pembrolizumab were 7.0 (95% CI, 6.0-8.4) months and 24.5 (95% CI, 20.1-29.3) months, respectively. In the subgroup with ECOG PS 0-1, they were 7.6 months (95% CI, 6.2-9.2) and 28.8 months (95% CI, 22.4-37.5), respectively. Of the 103 patients who completed ≥17 cycles, 57 (55.3%) patients received 17 - 34 cycles and 46 (44.7%) patients received ≥35 cycles. Approximately 7.7% of the study population received pembrolizumab beyond 35 cycles. Most common reasons for discontinuation were disease progression (38.6%) and toxicity (19.3%) among patients who received 17-34 cycles of pembrolizumab, and disease progression (13.0%) and completion of therapy (10.9%) among patients who received ≥35 cycles. Conclusion: Consistent with findings from KEYNOTE-024 and other real-world studies, this study demonstrates the long-term effectiveness of pembrolizumab monotherapy as 1L treatment for mNSCLC with PD-L1 TPS ≥50%. Among patients who completed ≥17 cycles, nearly half completed ≥35 cycles. Disease progression and toxicity were the most common reasons for discontinuation among patients who received 17-34 cycles of pembrolizumab. Reasons for discontinuation beyond 35 cycles need further exploration.
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PURPOSE: To characterize treatment patterns and real-world clinical outcomes of patients with metastatic non-small cell lung cancer (mNSCLC) who developed progression on an anti-PD-1/anti-PD-L1, herein referred to as anti-PD-(L)1, and platinum-doublet chemotherapy. METHODS: Eligible oncologists/pulmonologists in the United States, Europe (France, Germany, and United Kingdom), and Japan completed electronic case report forms for patients with mNSCLC (no evidence of EGFR/ALK/ROS1 alterations). Eligible patients had disease progression on/after an anti-PD-(L)1 and platinum-doublet chemotherapy (received concurrently or sequentially), initiated a subsequent line of therapy (LOT) between 2017 and 2021, and had an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at this subsequent LOT initiation (index date). Overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS) after index were assessed using Kaplan-Meier analysis. RESULTS: Overall, 160 physicians (academic, 54.4%; community, 45.6%) provided deidentified data from 487 patient charts (United States, 141; Europe, 218; Japan, 128; at mNSCLC diagnosis: median age 66 years, 64.7% male, 81.3% nonsquamous, 86.2% de novo mNSCLC; at line of interest initiation: 86.0% ECOG 0-1, 39.6% liver metastases, 18.9% brain metastases, 79.1% smoking history). The most common treatment regimens upon progression after anti-PD-(L)1/platinum-doublet chemotherapy were nonplatinum chemotherapy (50.5%), nonplatinum chemotherapy plus vascular endothelial growth factor receptor inhibitor (12.9%), and platinum-doublet chemotherapy (6.6%). Median OS was 8.8 months (squamous, 7.8 months; nonsquamous, 9.5 months). Median TTD was 4.3 months (squamous, 4.1 months; nonsquamous, 4.3 months). Median rwPFS was 5.1 months (squamous, 4.6 months; nonsquamous, 5.4 months). CONCLUSION: In this multiregional, real-world analysis of pooled patient chart data, patients with mNSCLC who had disease progression after anti-PD-(L)1/platinum-doublet chemotherapy had poor clinical outcomes with various treatment regimens, demonstrating an unmet clinical need for effective options after failure on anti-PD-(L)1 and platinum-doublet chemotherapy treatments.
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Carcinoma Pulmonar de Células não Pequenas , Carcinoma de Células Escamosas , Neoplasias Pulmonares , Humanos , Masculino , Estados Unidos , Idoso , Feminino , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Platina/uso terapêutico , Japão , Proteínas Tirosina Quinases/uso terapêutico , Fator A de Crescimento do Endotélio Vascular/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Proteínas Proto-Oncogênicas/uso terapêutico , Imunoterapia , Progressão da Doença , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/etiologiaRESUMO
Background: This study explored factors associated with the differences between women and men in attitudes, norms, and the support of taxation of menstrual products (MPs) and menstrual-adjacent products. It also investigated the use of these products in women. Methods: Young adults from 18 to 30 years of age were recruited via social media, listserve emails, and flyers placed throughout a university campus. Following cognitive interviewing, a survey investigated attitudes, beliefs, and behaviors associated with MPs. Results: Individuals self-identified as men or women. Women (n = 154) had more positive general attitudes, less positive safety attitudes, and less support for taxation of MPs than men (n = 43). Regression analyses indicated that factors, such as race, age, attitudes, norms, and taxation, were associated with product use. Conclusions: Attitudes about safety and taxation differ for men and women. Tax policies and attitude-shifting interventions need to be tailored to their audience, and our study can inform that effort.
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Conhecimentos, Atitudes e Prática em Saúde , Produtos de Higiene Menstrual , Impostos , Humanos , Feminino , Adulto , Masculino , Adulto Jovem , Adolescente , Inquéritos e Questionários , Fatores SexuaisRESUMO
PURPOSE: The American Academy of Pediatrics emphasized in a 2007 policy statement the importance of educating trainees on the impacts of climate change on children's health, yet few studies have evaluated trainee knowledge and attitudes about climate change-related health effects in children. This multi-institution study assessed pediatric resident and program director (1) knowledge/attitudes on climate change and health, (2) perspectives on the importance of incorporating climate and health content into pediatric graduate medical education, and (3) preferred topics/activities to include in climate and health curricula. METHOD: This mixed-methods study employed an anonymous cross-sectional survey of pediatric residents and residency program directors from Association of Pediatric Program Directors (APPD) Longitudinal Educational Assessment Research Network (LEARN)-affiliated programs. Multivariable regression models and factor analyses were used to examine associations among resident demographics and resident knowledge, attitudes, and interest in a climate change curriculum. A conventional content analysis was conducted for the open-ended responses. RESULTS: Eighteen programs participated in the study with all program directors (100% response rate) and 663 residents (average response rate per program, 53%; overall response rate, 42%) completing respective surveys. Of the program directors, only 3 (17%) felt very or moderately knowledgeable about the association between climate change and health impacts. The majority of residents (n=423, 64%) agreed/strongly agreed that physicians should discuss global warming/climate change and its health effects with patients/families, while only 138 residents (21%) agreed/strongly agreed that they were comfortable talking with patients and families about these issues. Most residents (n=498, 76%) and program directors (n=15, 83%) agreed/strongly agreed that a climate change curriculum should be incorporated into their pediatrics training program. CONCLUSIONS: Pediatric residents and program directors support curricula that prepare future pediatricians to address the impact of climate change on children's health; however, few programs currently offer specific training, despite identified needs.
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Mudança Climática , Currículo , Internato e Residência , Pediatria , Humanos , Pediatria/educação , Estudos Transversais , Masculino , Feminino , Adulto , Estados Unidos , Atitude do Pessoal de Saúde , Inquéritos e Questionários , Educação de Pós-Graduação em Medicina , Saúde da CriançaRESUMO
Objective: Adequate physician-patient communication about cancer recurrence is vital to quality of life and to informed decision-making related to survivorship care. The current study was guided by a cognitive-affective framework to examine communication with family and physicians about breast cancer recurrence risk. Methods: A survey of recently-diagnosed, early-stage breast cancer patients in Appalachia investigated physician-patient and familial communication about breast cancer recurrence risk. Results: Over 30% of participants reported not talking to family or physicians about breast cancer recurrence risk. Younger patients reported more conversations, and speaking with physicians was associated with greater perception risk factors associated with recurrence risk. Greater worry about recurrence was associated with more communication with family and plans to talk to family, physicians, and friends about recurrence risk in the future. Conclusion: Additional supports for patients and physicians are needed to improve understanding of breast cancer recurrence risk and risk factors for recurrence. Innovation: Family communication about breast cancer recurrence risk is understudied. The combination of physician and family communication adds novelty to our analysis.
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Introduction: This study evaluated the accuracy of motion signals extracted from video monitoring data to differentiate epileptic motor seizures in patients with drug-resistant epilepsy. 3D near-infrared video was recorded by the Nelli® seizure monitoring system (Tampere, Finland). Methods: 10 patients with 130 seizures were included in the training dataset, and 17 different patients with 98 seizures formed the testing dataset. Only seizures with unequivocal hyperkinetic, tonic, and tonic-clonic semiology were included. Motion features from the catch22 feature collection extracted from video were explored to transform the patients' videos into numerical time series for clustering and visualization. Results: Changes in feature generation provided incremental discrimination power to differentiate between hyperkinetic, tonic, and tonic-clonic seizures. Temporal motion features showed the best results in the unsupervised clustering analysis. Using these features, the system differentiated hyperkinetic, tonic and tonic-clonic seizures with 91, 88, and 45% accuracy after 100 cross-validation runs, respectively. F1-scores were 93, 90, and 37%, respectively. Overall accuracy and f1-score were 74%. Conclusion: The selected features of motion distinguished semiological differences within epileptic seizure types, enabling seizure classification to distinct motor seizure types. Further studies are needed with a larger dataset and additional seizure types. These results indicate the potential of video-based hybrid seizure monitoring systems to facilitate seizure classification improving the algorithmic processing and thus streamlining the clinical workflow for human annotators in hybrid (algorithmic-human) seizure monitoring systems.
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Introduction: Pembrolizumab plus carboplatin and (nab-)paclitaxel (pembrolizumab-chemotherapy) is currently an approved and recommended systemic therapy for patients with previously untreated advanced squamous NSCLC. This retrospective study evaluated real-world time on treatment (rwToT) and overall survival (OS) among patients with advanced squamous NSCLC treated with first-line pembrolizumab-chemotherapy at oncology practices in the United States. Methods: Using a real-world database, we selected adult patients with newly diagnosed or recurrent advanced squamous NSCLC (unresectable stages IIIB, IIIC, or IV) and good performance status (Eastern Cooperative Oncology Group 0-1) who initiated first-line pembrolizumab-chemotherapy from November 1, 2018, to May 31, 2020. The Kaplan-Meier method was used to determine rwToT and OS overall and by programmed death-ligand 1 (PD-L1) expression. Data cutoff was October 31, 2021. Results: Of 364 eligible patients, 243 (67%) were men; median age was 70 (range: 43-84) years; and PD-L1 expression was greater than or equal to 1%, less than 1%, and unknown for 172 (47%), 94 (26%), and 98 patients (27%), respectively. Median follow-up from pembrolizumab-chemotherapy initiation to data cutoff was 26.2 months. Overall, median pembrolizumab rwToT was 6.5 months (95% confidence interval [CI]: 5.6-7.6), with on-treatment rates of 29.3% and 15.9% at 12 and 24 months, respectively. Median OS was 15.3 months (95% CI: 11.7-18.6), with 12- and 24-month OS rates of 54.9% and 37.3%, respectively. Median OS did not differ with PD-L1 expression: 16.2 months (95% CI: 10.3-20.6) for PD-L1 greater than or equal to 1% and 17.2 months (95% CI: 10.8-20.6) for PD-L1 less than 1%. Conclusions: For patients with advanced squamous NSCLC and good performance status treated with first-line pembrolizumab-chemotherapy, rwToT and OS are similar to clinical trial findings for treatment duration and OS.
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PURPOSE: To describe trends and patterns of initial percutaneous nephrolithotomy (PCNL) and subsequent procedures from 2010 to 2019 among commercially-insured US adults with urinary system stone disease (USSD). METHODS: Retrospective study of administrative data from the IBM® MarketScan® Database. Eligible patients were aged 18-64 years and underwent PCNL between 1/1/2010 and 12/31/2019. Measures of interest for analysis of trends and patterns included the setting of initial PCNL (inpatient vs. outpatient), percutaneous access (1 vs. 2-step), and the incidence, time course, and type of subsequent procedures (extracorporeal shockwave lithotripsy [SWL], ureteroscopy [URS], and/or PCNL) performed up-to 3 years after initial PCNL. RESULTS: A total of 8,348 patients met the study eligibility criteria. During the study period, there was a substantial shift in the setting of initial PCNL, from 59.9% being inpatient in 2010 to 85.3% being outpatient by 2019 (P < 0.001). The proportion of 1 vs. 2-step initial PCNL fluctuated over time, with a low of 15.1% in 2016 and a high of 22.0% in 2019 but showed no consistent yearly trend (P = 0.137). The Kaplan-Meier estimated probability of subsequent procedures following initial PCNL was 20% at 30 days, 28% at 90 days, and 50% at 3 years, with slight fluctuations by initial PCNL year. From 2010 to 2019, the proportion of subsequent procedures accounted for by URS increased substantially (from 30.8 to 51.8%), whereas SWL decreased substantially (from 39.5 to 14.7%) (P < 0.001). CONCLUSIONS: From 2010 to 2019, PCNL procedures largely shifted to the outpatient setting. Subsequent procedures after initial PCNL were common, with most occurring within 90 days. URS has become the most commonly-used subsequent procedure type.
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Seguro Saúde , Nefrolitotomia Percutânea , Cálculos Urinários , Adulto , Humanos , Litotripsia/estatística & dados numéricos , Litotripsia/tendências , Nefrolitotomia Percutânea/estatística & dados numéricos , Nefrolitotomia Percutânea/tendências , Nefrostomia Percutânea/estatística & dados numéricos , Nefrostomia Percutânea/tendências , Estudos Retrospectivos , Ureteroscopia/estatística & dados numéricos , Ureteroscopia/tendências , Cálculos Urinários/cirurgia , Estados Unidos , Seguro Saúde/estatística & dados numéricos , Adolescente , Adulto Jovem , Pessoa de Meia-IdadeRESUMO
Purpose: This study describes the incremental healthcare costs associated with retreatment among adults undergoing ureteroscopy (URS) or percutaneous nephrolithotomy (PCNL) for upper urinary tract stones (UUTS). Patients and Methods: The IBM® MarketScan® Commercial Database was used to identify adults aged 18-64 years with UUTS treated with URS or PCNL between January 2010 and December 2019. Patients had 12 months of continuous insurance coverage before (baseline) and after (follow-up) the first (index) procedure. The primary outcome was total all-cause healthcare costs measured over the 365-day follow-up period, not inclusive of index costs. Generalized linear models were used to estimate the incremental costs associated with retreatment within 90 (early) or 91-365 days post-index (later) relative no retreatment. The models adjusted for demographics, comorbidities, stone(s) location, treatment setting, procedural characteristics (eg, 1-step vs 2-step PCNL) and index year. Results: Approximately 23% (27,402/119,800) of URS patients were retreated (82% had early retreatments). The adjusted mean total cost was $10,478 (95% CI: $10,281-$10,675) for patients with no retreatment, $25,476 (95% CI: $24,947-$26,004) for early retreatment ($14,998 incremental increase, p<0.01), and $32,868 [95% CI: $31,887-$33,850] for later retreatment ($22,391 incremental increase, p<0.01). Approximately 36% (1957/5516) of PCNL patients were retreated (78% had early retreatments). The adjusted mean total cost was $13,446 (95% CI: $12,659-$14,273) for patients with no retreatment, $37,036 [95% CI: $34,926-$39,145]) for early retreatment ($23,570 incremental increase, p<0.01), and $35,359 (95% CI: $32,234-$38,484) for later retreatment ($21,893 incremental increase, p<0.01). Conclusion: Retreatment during the first year following URS or PCNL was needed in 23% and 36% of patients, respectively, and was associated with an economic burden of up to $23,500 per patient. The high rate of retreatment and associated costs demonstrate there is an unmet need to improve mid- to long-term results in URS and PCNL.
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INTRODUCTION: The outbreak of coronavirus disease in Nepal led medical colleges to suspend in person teaching-learning activities and ultimately online platform was introduced to deliver the contents of medical education. The objective of this study was to describe the perception of medical students towards online teaching-learning introduced during the COVID-19 outbreak in Nepal. METHODS: An online survey using a descriptive cross-sectional study design was carried out among 515 undergraduate medical students currently enrolled in medical colleges in Nepal. Ethical approval was sought from Nepal Health Research Council to conduct this study, and digital informed consent was taken from study respondents. A semi-structured questionnaire in Google form was utilized to collect data. The link of the Google form was sent to the potential respondents through email and social media. Descriptive statistics, including frequency, percentage, mean, and standard deviation were used to analyze data in Stastical Package for the Social Sciences version 20. Ethical approval was sought from Nepal Health Research Council to conduct this study, and digital informed consent was taken from study respondants. RESULTS: The overall score of perception of online teaching-learning was 17.61±7.19, which indicated many problems in this method of teaching-learning. The mean score of perception of online teaching-learning was found to be different across sex, location of enrolled medical colleges, having a personal electronic device, having an internet connection at residence, having separate room/space for attending online classes, and self-rated computer skills. Moreover, only 28 (5.4%) of respondents had perceived online teaching-learning as a better method of delivering content of medical curricula. CONCLUSIONS: Surveyed medical students in Nepal were found to perceive many problems in online teaching-learning. Moreover, management and faculty members need to take the necessary measures for enhancing the online teaching-learning quality.
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COVID-19 , Educação Médica , Estudantes de Medicina , Estudos Transversais , Surtos de Doenças , Humanos , Nepal/epidemiologia , Percepção , SARS-CoV-2RESUMO
PURPOSE: The ability of curved cutter staplers (CCS) to conform to the complex anatomy of the rectum has led to their widespread use in open low anterior resection (LAR). We describe the incidence of complications and their association with healthcare utilization and hospital-borne costs among patients who underwent open LAR with CCS, with the intent to provide contextual epidemiologic and economic burden data for future evaluations of innovations that may lead to a reduced incidence of complications. METHODS: Retrospective cohort study using Premier Healthcare Database. Studied patients were ≥18 years who underwent inpatient open LAR with CCS between October 1, 2016 and March 30, 2020 (index admission). Complications of interest included anastomotic leak, bleeding, infection, transfusion, and device complications/adverse incidents during the index admission. Outcomes included index admission hospital length of stay (LOS), non-home discharge status, total operating room (OR) time, total hospital-borne costs, and all-cause readmissions within 30, 60, and 90 days post discharge from index admission. Multivariable regression models were used to compare outcomes between patients with vs without any complication of interest. RESULTS: The study included 618 patients with a mean age of 61 years, of whom 57% were males. The incidence proportion of any complication during the index admission for open LAR with CCS was 28% (95% CI: [23.9%, 31.0%], n=170). As compared with patients experiencing no complications, those with a complication had higher adjusted mean total hospital costs ($38,159 vs $22,303, p<0.001), non-home discharge status (21.8% vs 9.2%, p=0.004), mean LOS (13 days vs 6 days, p<0.001), and mean OR time (362 mins vs 291 mins, p<0.001). There were no significant differences in all-cause readmissions between patients with vs without complications. CONCLUSION: Among patients undergoing open LAR with CCS, over a quarter of patients experienced a complication, resulting in a substantial burden to the healthcare system.
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PURPOSE: Open colorectal surgery is associated with a high rate of postoperative wound complications. This is a single-arm study of real-world outcomes of triclosan-coated barbed suture (Ethicon's STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device [SSPP]) used in open colorectal surgery. METHODS: Retrospective cohort study using the Premier Healthcare Database. The study included patients who underwent an inpatient open colorectal surgery with wound closure using SSPP (size 0 or 1 to increase the likelihood the suture was used in fascia) between October 2015-September 2019 (N=593). Wound complications, hospital length of stay, total hospital costs (2019 US$), and all-cause readmissions post-discharge were measured. Post-hoc multivariable analyses compared wound complications between non-elective admissions and elective. RESULTS: The overall incidence of wound complications within 30-days post-procedure was 7.1%, with the majority of those being surgical site infections (SSI) (6.0%). Mean operation time was 190 (standard deviation [SD]=64.4) mins, postoperative length of stay was 8.1 (SD=11.9) days, 30-day readmission rate was 11.8%, and total hospital costs were $31,693 (SD=$40,076). As compared with published literature on the rate of SSI in colorectal surgery, the 30-day rate of SSI in the present study (6.0%) fell within the range of 5.4% to 18.2% for open colorectal surgery and from 4.3% to 21.5% for combined open and minimally invasive procedures. Multivariable-adjusted incidence proportions of wound complications were slightly lower for non-elective admissions and did not differ significantly from those of elective admissions. CONCLUSION: The rate of wound complications observed in the present study falls within the range of rates previously reported in the literature, suggesting a safe and effective role for SSPP in open colorectal surgery. In post hoc analyses, the adjusted rate of wound complications was similar between non-elective and elective admissions. Head-to-head studies are required to determine comparative advantages or disadvantages for SSPP versus other sutures.
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ABSTRACT: Improvement in overall survival by immune checkpoint inhibitors (ICI) treatment in clinical trials encourages their use for late-stage melanoma. However, in the real-world, heterogeneity of population, such as older patients with multimorbidity, may lead to a slower diffusion of ICIs. The objective of this study was to examine the association of multimorbidity and other factors to ICI use among older patients with late-stage melanoma using real world data.A retrospective cohort study design with a 12-month baseline and follow-up period was adopted with data from the linked Surveillance, Epidemiology, and End Results cancer registry/Medicare database. Older patients (>65âyears) with late-stage (stage III/IV) melanoma diagnosed between 2012 and 2015 were categorized as with or without multimorbidity (presence of 2 or more chronic conditions) and ICI use was identified in the post-index period. Chi-square tests and logistic regression were used to evaluate factors associated with ICI use.In the study cohort, 85% had multimorbidity, 18% received any treatment (chemotherapy, radiation, and/or ICI), and 6% received ICI. Only 5.5% of older patients with multimorbidity and 6% without multimorbidity received ICIs. Younger age, presence of social support, lower economic status, residence in northeastern regions, and recent year of diagnosis were significantly associated with ICI use; however, multimorbidity, sex, and race were not associated with ICI use.In the real-world clinical practice, only 1 in 18 older adults with late stage melanoma received ICI, suggesting slow pace of diffusion of innovation. However, multimorbidity was not a barrier to ICI use.
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Inibidores de Checkpoint Imunológico/uso terapêutico , Melanoma/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Melanoma/mortalidade , Multimorbidade , Estadiamento de Neoplasias , Sistema de Registros , Estudos Retrospectivos , Estados Unidos/epidemiologiaRESUMO
Background: The objective of this study is to assess the impact of immune checkpoint inhibitors (ICIs) and multimorbidity on healthcare expenditures among older patients with late-stage melanoma. Materials & methods: A retrospective longitudinal cohort study using Surveillance, Epidemiology and End Results linked with Medicare claims was conducted. Generalized linear mixed models were used to analyze adjusted relationships of ICI, multimorbidity and ICI-multimorbidity interaction on average healthcare expenditures. Results: Patients who received ICI and those who had multimorbidity had significantly higher average total healthcare expenditures compared with ICI nonusers and no multimorbidity. In the fully adjusted model using ICI-multimorbidity interaction, no excess cost was added by multimorbidity. Conclusion: Use of ICIs, regardless of multimorbidity, is associated with increased healthcare expenditures.
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Gastos em Saúde/estatística & dados numéricos , Inibidores de Checkpoint Imunológico/economia , Melanoma/economia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Inibidores de Checkpoint Imunológico/uso terapêutico , Estudos Longitudinais , Masculino , Medicare , Melanoma/tratamento farmacológico , Melanoma/epidemiologia , Melanoma/patologia , Multimorbidade , Estudos Retrospectivos , Estados Unidos/epidemiologiaRESUMO
INTRODUCTION: Presence of multimorbidity can affect prognosis, treatment, and outcomes of individuals with cancer. However, the prevalence and factors associated with multimorbidity among older late-stage melanoma is not well studied. We estimated the prevalence of any type of pre-existing multimorbidity (autoimmune disorder (AD), physical health conditions (PHC), and mental health conditions (MHC)) among older adults with late-stage melanoma in the United States. We further examined the association of patient-level factors to multimorbidity in late-stage melanoma. METHODS: We derived data on older fee-for-service Medicare beneficiaries (age ≥ 66 years) diagnosed with late-stage melanoma between 2011 and 2015 (N = 4,519) from the linked Surveillance, Epidemiology, and End Results cancer registry and Medicare claims. We defined multimorbidity as the prevalence of two or more chronic conditions prior to the diagnosis of melanoma. We used unadjusted and adjusted logistic regressions to examine the association of patient-level factors to multimorbidity. RESULTS: An overwhelming majority (85%) of older patients with late-stage melanoma had multimorbidity. Pre-existing PHC multimorbidity (84%) was the most prevalent, followed by AD (12%), and MHC (6%). Age and region were associated with any and PHC multimorbidity. Sex, marital status, and region were factors associated with pre-existing AD while sex, marital status, and dual eligibility were associated with MHC multimorbidity. CONCLUSIONS: Pre-existing multimorbidity was highly prevalent among older individuals with late-stage melanoma; prevalence rates and factors associated with multimorbidity varied by type of chronic conditions. This highlights the need for developing systematic approaches to optimizing care of older patients with late-stage melanoma and multimorbidity.
Assuntos
Melanoma , Multimorbidade , Idoso , Doença Crônica , Estudos Transversais , Humanos , Medicare , Melanoma/epidemiologia , Melanoma/terapia , Prevalência , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
Indigenous preparations (IPs) have evoked a considerable interest in alleviating infections and chronic diseases and improving wellbeing. While such formulations have been a part of traditional practice in several countries and many have been reviewed scientifically for their claims, several of them until date remain to be investigated. A class of IPs for sex selection by Indian pregnant women exists with an aim of begetting a male offspring. In view of the leads obtained from our previous studies on detrimental effects of the newborn, for instance stillbirths and congenital malformations, we attempted to investigate the samples for heavy metal toxicity. Three samples were chosen following phytochemical analysis and reproductive toxicity of such preparations under in vivo conditions. The selected samples were examined for heavy metals-lead, cadmium, arsenic, and mercury using Microwave-assisted atomic absorption spectroscopy. The upper limit level of lead, mercury, and cadmium was found to be 18.56, 0.11, and 0.84 mg/kg respectively whereas arsenic was not detected. The levels of lead and mercury were found to be manifolds high in the IP samples that were primarily contributed by its constituents. The results of our study indicate the potential risk conferred upon, to both the mother and fetus on account of high levels of lead, mercury, and cadmium.