Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 24
Filtrar
Mais filtros








Base de dados
Intervalo de ano de publicação
1.
Neurosurgery ; 2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-38990004

RESUMO

BACKGROUND AND OBJECTIVES: The "July Effect" hypothesizes increased morbidity and mortality after the addition of inexperienced physicians at the beginning of an academic year. However, the impact of newer members on neurosurgical teams managing patients with traumatic brain injury (TBI) has yet to be examined. This study conducted a nationwide analysis to evaluate the existence of the "July Effect" in the setting of patients with TBI. METHODS: The Healthcare Cost and Utilization Project Central Distributor's National Inpatient Sample data set was queried for patients with TBI using International Classification of Diseases (ICD)-9 and ICD-10 codes. Discharges were included for diagnoses of traumatic epidural, subdural, or subarachnoid hemorrhages. Only patients treated at teaching hospitals were included to ensure resident involvement in care. Patients were grouped into July admission and non-July admission cohorts. A subgroup of patients with neurotrauma undergoing any form of cranial surgery was created. Perioperative variables were recorded. Rates of different complications were assayed. Groups were compared using χ2 tests (qualitative variables) and t-tests or Mann-Whitney U-tests (quantitative variables). Logistic regression was used for binary variables. Gamma log-linked regression was used for continuous variables. RESULTS: The National Inpatient Sample database yielded a weighted average of 3 160 452 patients, of which 312 863 (9.9%) underwent surgical management. Patients admitted to the hospital in July had a 5% decreased likelihood of death (P = .027), and a 5.83% decreased likelihood of developing a complication (P < .001) compared with other months of the year. July admittance to a hospital showed no significant impact on mean length of stay (P = .392) or routine discharge (P = .147). Among patients with TBI who received surgical intervention, July admittance did not significantly affect the likelihood of death (P = .053), developing a complication (P = .477), routine discharge (P = .986), or mean length of stay (P = .385). CONCLUSION: The findings suggested that there is no "July Effect" on patients with TBI treated at teaching hospitals in the United States.

2.
Support Care Cancer ; 32(8): 494, 2024 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-38977496

RESUMO

PURPOSE: Palliative care plays essential roles in cancer care. However, differences in receipt among individuals identifying as Asian American, Native Hawaiian, and Other Pacific Islanders (AA&NHPI) with cancer are not well-characterized, especially when these diverse groups are disaggregated. We characterized disparities in receipt of palliative care among AA&NHPI patients with AJCC Stage IV prostate, breast, or lung cancer. METHODS: We performed multivariable logistic regressions were performed in this retrospective cohort analysis, using deidentified data from the National Cancer Database (NCDB) of patients diagnosed with AJCC analytic group stage IV breast, lung, or prostate cancer (2004-2018) who were White or of Asian Indian/Pakistani, Chinese, Filipino, Hawaiian, Hmong, Japanese, Kampuchean, Korean, Laotian, Other Pacific Islander, Thai, or Vietnamese descent. We conducted multivariable logistic regression analyses in a retrospective cohort study using deidentified data from the National Cancer Database (NCDB). The study included patients diagnosed with AJCC analytic group Stage IV breast, lung, or prostate cancer between 2004 and 2018, who were White or identified as Asian Indian/Pakistani, Chinese, Filipino, Hawaiian, Hmong, Japanese, Kampuchean, Korean, Laotian, Other Pacific Islander, Thai, or Vietnamese descent. Adjusted odds ratios and 95% confidence intervals of receiving palliative care were measured when comparing White vs. AA&NHPI patients as one cohort and White vs. disaggregated AA&NHPI patients, adjusting for clinical, socioeconomic, and demographic covariates. RESULTS: Among 775,289 individuals diagnosed with cancer (median age: 68 years), no significant differences in palliative care receipt were observed between White patients and aggregated AA&NHPI patients among patients with prostate, breast, or lung cancer. However, disaggregated analyses revealed reduced palliative care receipt for breast cancer patients of Asian Indian/Pakistani descent (AOR 0.75, 95% CI, 0.60-0.94, P = 0.011) and for lung cancer patients of Chinese, Vietnamese, Thai, and Asian Indian/Pakistani descent compared to White patients (Chinese AOR 0.88, [0.81-0.94], P = 0.001; Vietnamese AOR 0.89, [0.80 to 0.99], P = 0.032; Thai AOR 0.64, [0.44-0.92], P = 0.016; Asian Indian/Pakistani AOR 0.83, [0.74-0.93], P = 0.001). Palliative care was greater for patients of Japanese and Hawaiian descent with prostate cancer (Japanese AOR 1.92, [1.32-2.75], P = 0.001; Hawaiian AOR 2.09, [1.20-3.66], P = 0.009), breast cancer (Japanese AOR 1.72, [1.21-2.43], P = 0.001; Hawaiian AOR 1.70, [1.08-2.67], P = 0.021), and lung cancer (Japanese AOR 1.92, [1.70-2.17], P < 0.001; Hawaiian AOR 2.95, [2.5-3.5], P < 0.001), as well as patients of Other Pacific Islander descent with lung cancer (AOR 1.62, [1.34-1.96], P < 0.001). CONCLUSIONS AND RELEVANCE: Our findings demonstrate disparities in receipt of palliative care upon disaggregation of diverse AA&NHPI groups, the need for disaggregated research and targeted interventions that address the unique cultural, socioeconomic, and healthcare system barriers to palliative care receipt.


Assuntos
Asiático , Disparidades em Assistência à Saúde , Havaiano Nativo ou Outro Ilhéu do Pacífico , Cuidados Paliativos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Asiático/estatística & dados numéricos , Neoplasias da Mama/terapia , Neoplasias da Mama/patologia , Neoplasias da Mama/etnologia , Estudos de Coortes , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Modelos Logísticos , Neoplasias Pulmonares/terapia , Neoplasias Pulmonares/etnologia , Neoplasias Pulmonares/patologia , Havaiano Nativo ou Outro Ilhéu do Pacífico/estatística & dados numéricos , Metástase Neoplásica , Neoplasias/terapia , Neoplasias/etnologia , Neoplasias/patologia , Cuidados Paliativos/estatística & dados numéricos , Neoplasias da Próstata/terapia , Neoplasias da Próstata/etnologia , Neoplasias da Próstata/patologia , Estudos Retrospectivos , Estados Unidos
3.
Eur J Cancer ; 207: 114192, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38959677

RESUMO

CDK4/6 inhibitors are oral agents inhibiting key molecules of the cell cycle regulation. In patients with endocrine receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer, the combination of CDK4/6 inhibitors with endocrine therapy is an effective treatment in the metastatic setting. Now, two studies in the adjuvant setting - MonarchE (2 years of abemaciclib) and NATALEE (3 years of ribociclib) - report positive invasive disease-free survival. Here, we re-evaluate these seminal trials. First, an excess drop-out or loss-to-follow up occurred early in the control arms of both studies. Since both trials are open-label, there is concern that the patients who drop-out do not do so at random but based on socioeconomic factors and alternative options. Is it possible that the results merely appear favorable due to loss to follow up? Based on re-constructed Kaplan-Meier curves, we concluded the results of these studies remain fragile, being prone to informative censoring. Secondly, adverse events were notably higher in both trials, and some of them, like COVID-19 related deaths in NATALEE, raise serious concerns. Third, the potential costs associated with CDK4/6 inhibition given as adjuvant therapy are unprecedented. The NATALEE strategy, in particular, could affect up to 35 % of patients with newly diagnosed breast cancer, which is the cancer with the highest incidence worldwide. Without confirmatory data based on a placebo-controlled trial, or better identification of patients that would benefit from the addition of CDK4/6 inhibitors in the adjuvant setting, we argue against their routine use as adjuvant therapy in ER+ /HER2- early breast cancer.


Assuntos
Neoplasias da Mama , Quinase 4 Dependente de Ciclina , Quinase 6 Dependente de Ciclina , Inibidores de Proteínas Quinases , Feminino , Humanos , Aminopiridinas/uso terapêutico , Aminopiridinas/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Benzimidazóis/uso terapêutico , Benzimidazóis/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Quinase 4 Dependente de Ciclina/antagonistas & inibidores , Quinase 6 Dependente de Ciclina/antagonistas & inibidores , Inibidores de Proteínas Quinases/uso terapêutico , Inibidores de Proteínas Quinases/efeitos adversos , Purinas/uso terapêutico , Purinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Int J Med Inform ; 189: 105513, 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38851132

RESUMO

BACKGROUND: Patient engagement when providing patient access to health data results from an interaction between the available tools and individual capabilities. The recent digital advancements of the healthcare field have altered the manifestation and importance of patient engagement. However, a comprehensive assessment of what factors contribute to patient engagement remain absent. In this review article, we synthesised the most frequently discussed factors that can foster patient engagement with their health data. METHODS: A scoping review was conducted in MEDLINE, Embase, and Google Scholar. Relevant data were synthesized within 7 layers using a thematic analysis: (1) social and demographic factors, (2) patient ability factors, (3) patient motivation factors, (4) factors related to healthcare professionals' attitudes and skills, (5) health system factors, (6) technological factors, and (7) policy factors. RESULTS: We identified 5801 academic and 200 Gy literature records, and included 292 (4.83%) in this review. Overall, 44 factors that can affect patient engagement with their health data were extracted. We extracted 6 social and demographic factors, 6 patient ability factors, 12 patient motivation factors, 7 factors related to healthcare professionals' attitudes and skills, 4 health system factors, 6 technological factors, and 3 policy factors. CONCLUSIONS: Improving patient engagement with their health data enables the development of patient-centered healthcare, though it can also exacerbate existing inequities. While expanding patient access to health data is an important step towards fostering shared decision-making in healthcare and subsequently empowering patients, it is important to ensure that these developments reach all sectors of the community.

5.
J Cancer Policy ; 41: 100491, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38852671

RESUMO

IMPORTANCE: There is an increasing number of cancer 'survivors' and increasing research into supportive care. However, it is unknown how patterns of attention and citation differ between supportive and non-supportive cancer care research. We sought to estimate the engagement of high-impact studies of supportive compared to non-supportive cancer care papers. METHODS: In a cross-sectional review of top oncology journals (2016-2023), we reviewed studies examining supportive care strategies and a frequency-matched random sampling of studies on non-supportive interventions. We compared data on social engagement metrics, as represented by Altmetric scores and citations and funding status, by supportive care or non-supportive care articles. RESULTS: We found overall Altmetric scores were no different between articles that did not test supportive care and those that did, with a numerically higher score for supportive care articles (86.0 vs 102; p=0.416). Other bibliometric statistics (such as the number of blogs, number of X users, and the number of X posts) obtained from Altmetric did not differ significantly between the two groups. Non-supportive cancer care papers had a significantly higher number of citations than supportive cancer care papers (45.6 in supportive care vs 141 in non-supportive care papers; p<0.001). A greater proportion of non-supportive cancer care papers were also supported by pharmaceutical companies compared to supportive cancer care papers (54.2 % vs 15.3 %; p<0.001). CONCLUSION: Though social media engagement is similar between supportive and non-supportive cancer care papers in high-impact journals, there is a significant difference in support from pharmaceutical companies and the number of citations.

6.
Innovations (Phila) ; : 15569845241252441, 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38828943

RESUMO

Cardiovascular diseases are the leading cause of morbidity and mortality worldwide, costing the lives of 18 million people annually, with up to one-third being attributable to cardiac surgical conditions. Approximately 6 billion people do not have access to safe, timely, and affordable cardiac surgery, predominantly affecting populations living in low-middle income countries. Cardiac surgical care is costly, resulting in few centers in variable-resource contexts operating continuously or with the resources observed in higher-resource environments. As a result, innovations may be formally developed or informally adopted to bypass resource constraints and ensure care delivery. Innovations have been observed across the cardiac surgical care continuum and across settings, potentially benefiting both high-income countries, where growing health care costs are becoming unsustainable, and low- and middle-income countries, where competing health agendas may limit investments into cardiac surgery. This narrative review attempts to address the costs associated with cardiac surgery, placing an emphasis on frugal innovations in the perioperative and postoperative care spectrum.

7.
World Neurosurg ; 2024 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-38729521

RESUMO

OBJECTIVE: Basilar impression (BI) is a rare yet debilitating abnormality of the craniovertebral junction, known to cause life-threatening medullary brainstem compression. Our study analyzes surgical approaches for BI and related outcomes. METHODS: A systematic review was conducted using PubMed, Google Scholar, and Web of Science electronic databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to critically assess primary articles examining BI. RESULTS: We analyzed 87 patients from 65 articles, mostly female (55.17%) with a mean age of 46.31 ± 17.94 years, commonly presenting with motor (59.77%) and sensory deficits (55.17%). Commonly employed procedures included posterior occipitocervical fusion (24.14%), anterior decompression (20.69%), and combined anterior decompression with posterior fusion (21.84%). Patients who underwent anterior approaches were found to be older (55.38 ± 17.67 vs. 45.49 ± 18.78 years, P < 0.05) and had a longer duration from symptom onset to surgery (57.39 ± 64.33 vs. 26.02 ± 29.60 months, P < 0.05) compared to posterior approaches. Our analysis revealed a significant association between a longer duration from symptom onset to surgery and an increased likelihood of undergoing odontoidectomy and decompression (odds ratio: 1.02, 95% confidence interval: 1.00-1.03, P < 0.05). Furthermore, after adjusting for all other covariates, a history of rheumatoid arthritis and the use of a posterior approach were significantly associated with an elevated risk of postoperative complications (P < 0.05). CONCLUSIONS: The treatment approach to complex craniovertebral junction disease should be tailored to the surgeon's experience and the nature of the compressive pathology.

8.
World Neurosurg ; 189: 138-153, 2024 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-38789029

RESUMO

Brain-computer interfaces (BCIs), a remarkable technological advancement in neurology and neurosurgery, mark a significant leap since the inception of electroencephalography in 1924. These interfaces effectively convert central nervous system signals into commands for external devices, offering revolutionary benefits to patients with severe communication and motor impairments due to a myriad of neurological conditions like stroke, spinal cord injuries, and neurodegenerative disorders. BCIs enable these individuals to communicate and interact with their environment, using their brain signals to operate interfaces for communication and environmental control. This technology is especially crucial for those completely locked in, providing a communication lifeline where other methods fall short. The advantages of BCIs are profound, offering autonomy and an improved quality of life for patients with severe disabilities. They allow for direct interaction with various devices and prostheses, bypassing damaged or nonfunctional neural pathways. However, challenges persist, including the complexity of accurately interpreting brain signals, the need for individual calibration, and ensuring reliable, long-term use. Additionally, ethical considerations arise regarding autonomy, consent, and the potential for dependence on technology. Despite these challenges, BCIs represent a transformative development in neurotechnology, promising enhanced patient outcomes and a deeper understanding of brain-machine interfaces.

10.
World Neurosurg ; 186: e552-e565, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38599377

RESUMO

BACKGROUND: Socioeconomic status (SES) is a major determinant of quality of life and outcomes. However, SES remains difficult to measure comprehensively. Distress communities index (DCI), a composite of 7 socioeconomic factors, has been increasingly recognized for its correlation with poor outcomes. As a result, the objective of the present study is to determine the predictive value of the DCI on outcomes following intracranial tumor surgery. METHODS: A single institution, retrospective review was conducted to identify adult intracranial tumor patients undergoing resection (2016-2021). Patient ZIP codes were matched to DCI and stratified by DCI quartiles (low:0-24.9, low-intermediate:25-49.9, intermediate-high:50-74.9, high:75-100). Univariate followed by multivariate regressions assessed the effects of DCI on postoperative outcomes. Receiver operating curves were generated for significant outcomes. RESULTS: A total of 2389 patients were included: 1015 patients (42.5%) resided in low distress communities, 689 (28.8%) in low-intermediate distress communities, 445 (18.6%) in intermediate-high distress communities, and 240 (10.0%) in high distress communities. On multivariate analysis, risk of fracture (adjusted odds ratio = 1.60, 95% confidence interval 1.26-2.05, P < 0.001) and 90-day mortality (adjusted odds ratio = 1.58, 95% confidence interval 1.21-2.06, P < 0.001) increased with increasing DCI quartile. Good predictive accuracy was observed for both models, with receiver operating curves of 0.746 (95% CI 0.720-0.766) for fracture and 0.743 (95% CI 0.714-0.772) for 90-day mortality. CONCLUSIONS: Intracranial tumor patients from distressed communities are at increased risk for adverse events and death in the postoperative period. DCI may be a useful, holistic measure of SES that can help risk stratifying patients and should be considered when building healthcare pathways.


Assuntos
Neoplasias Encefálicas , Humanos , Masculino , Feminino , Neoplasias Encefálicas/cirurgia , Neoplasias Encefálicas/mortalidade , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Adulto , Fatores Socioeconômicos , Classe Social
11.
World Neurosurg ; 187: 104-113, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38649021

RESUMO

Spasticity is a potentially debilitating symptom of various acquired and congenital neurologic pathologies that, without adequate treatment, may lead to long-term disability, compromise functional independence, and negatively impact mental health. Several conservative as well as non-nerve targeted surgical strategies have been developed for the treatment of spasticity, but these may be associated with significant drawbacks, such as adverse side effects to medication, device dependence on intrathecal baclofen pumps, and inadequate relief with tendon-based procedures. In these circumstances, patients may benefit from nerve-targeted surgical interventions such as (i) selective dorsal rhizotomy, (ii) hyperselective neurectomy, and (iii) nerve transfer. When selecting the appropriate surgical approach, preoperative patient characteristics, as well as the risks and benefits of nerve-targeted surgical intervention, must be carefully evaluated. Here, we review the current evidence on the efficacy of these nerve-targeted surgical approaches for treating spasticity across various congenital and acquired neurologic pathologies.


Assuntos
Espasticidade Muscular , Rizotomia , Humanos , Espasticidade Muscular/cirurgia , Rizotomia/métodos , Procedimentos Neurocirúrgicos/métodos , Transferência de Nervo/métodos
12.
Surg Neurol Int ; 15: 88, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38628537

RESUMO

Background: Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients' understanding and engagement in the decision-making process. Methods: This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures. Results: The study will evaluate the impact of MR on patients' information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed. Conclusion: This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.

13.
Ann Med Surg (Lond) ; 86(2): 881-885, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38333284

RESUMO

Background: Hydrocephalus is a significant complication arising from tuberculous meningitis (TBM). While ventriculoperitoneal shunt (VPS) remains the primary surgical approach for TBM-related hydrocephalus, there is a rising trend in the use of endoscopic third ventriculostomy (ETV). Materials and methods: This randomized controlled trial, conducted from February 2018 to July 2019, enroled 60 patients aged 20-50 with TBM-related hydrocephalus. Patients underwent either VPS or ETV. Both groups were followed up for a minimum of 30 days, evaluating clinical outcomes and modifications in the modified Vellore grading system. Glasgow Coma Scale (GCS) assessments were conducted at 7-days and 30-day post-surgery for both groups. Results: The mean GCS scores were comparable between the two groups on the 7th and 30th postoperative days. The association between modified Vellore Grade and treatment modality did not show statistically significant differences (P=1.0 and P=0.3) on the seventh and thirtieth postoperative days respectively. Conclusions: Both VPS and ETV demonstrate efficacy in managing hydrocephalus secondary to TBM in adult patients. Our 30-day outcomes did not reveal discernible differences between the two procedures. Therefore, considering technical expertise and experience with ETV, it may be considered as the primary choice for cerebrospinal fluid (CSF) diversion in TBM-associated hydrocephalus, owing to its avoidance of several lifelong complications linked with VPS.

14.
Neurosurg Focus ; 56(1): E7, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38163345

RESUMO

OBJECTIVE: This study aimed to rigorously assess the accuracy of mixed-reality neuronavigation (MRN) in comparison with magnetic neuronavigation (MN) through a comprehensive phantom-based experiment. It introduces a novel dimension by examining the influence of blue-green light (BGL) on MRN accuracy, a previously unexplored avenue in this domain. METHODS: Twenty-nine phantoms, each meticulously marked with 5-6 fiducials, underwent CT scans as part of the navigation protocol. A 3D model was then superimposed onto a 3D-printed plaster skull using a semiautomatic registration process. The study meticulously evaluated the accuracy of both navigation techniques by pinpointing specific markers on the plaster surface. Precise measurements were then taken using digital calipers, with navigation conducted under three distinct lighting conditions: indirect white light (referred to as no light [NL]), direct white light (WL), and BGL. The research enlisted two operators with distinct levels of experience, one senior and one junior, to ensure a comprehensive analysis. The study was structured into two distinct experiments (experiment 1 [MN] and experiment 2 [MRN]) conducted by the two operators. Data analysis focused on calculating average and median values within subgroups, considering variables such as the type of lighting, precision, and recording time. RESULTS: In experiment 1, no statistically significant differences emerged between the two operators. However, in experiment 2, notable disparities became apparent, with the senior operator recording longer times but achieving higher precision. Most significantly, BGL consistently demonstrated a capacity to enhance accuracy in MRN across both experiments. CONCLUSIONS: This study demonstrated the substantial positive influence of BGL on MRN accuracy, providing profound implications for the design and implementation of mixed-reality systems. It also emphasized that integrating BGL into mixed-reality environments could profoundly improve user experience and performance. Further research is essential to validate these findings in real-world settings and explore the broader potential of BGL in a variety of mixed-reality applications.


Assuntos
Realidade Aumentada , Neuronavegação , Humanos , Neuronavegação/métodos , Luz Verde , Tomografia Computadorizada por Raios X , Crânio
15.
J Cancer Policy ; 39: 100462, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38061492

RESUMO

IMPORTANCE: Understanding the factors that are associated with new molecular entity (NME) cancer drug approvals as a single agent and in combination, and European Society for Medical Oncology (ESMO) scores, can aid in identifying suitable factors to consider in trial designs for future drugs. In addition, the association between the various outcomes can aid in determining benefit when surrogate outcomes are used in approval consideration. OBJECTIVE: This study aims to (1) use the measures used in evaluating clinical trials by ESMO scores to determine the differences in the characteristics of 2013-2022 Food and Drug Administration (FDA) oncology NME drug approvals for those approved for use in combination or as a monotherapy, and (2) analyze the association between survival outcomes and the response rate for monotherapy NME drugs and/or drugs approved in combination. DESIGN: Cross-sectional analysis. SETTING: US FDA Oncology Drug Approvals (2013-2022) PARTICIPANTS: US FDA Oncology Drug Approvals (2013-2022) EXPOSURES: Trial-level characteristics (tumor types, basis of approval, randomized or not, phase) and associations between overall survival (OS), progression-free survival (PFS), or overall response rate (ORR) and whether NME drugs were approved as monotherapy or in combination . RESULTS: Drugs approved for use as a monotherapy are less likely to be approved using a randomized study (p < 0.001) and more likely to be approved via the accelerated pathway (p = 0.012) and be open-label (p < 0.001). Drugs approved for use as a combination or monotherapy significantly differed on their approval basis (p = 0.002), phase of trial at the time of approval (p = 0.02), and ESMO scores (p = 0.02). There was low correlation between response rate and either PFS or OS metrics. However, nearly all of the drugs with large improvements in OS (> 5months) were drugs with robust ORR. CONCLUSIONS AND RELEVANCE: Drugs approved as monotherapy with a low response rate are likely to have marginal benefit in OS and PFS.


Assuntos
Antineoplásicos , Neoplasias , Humanos , Aprovação de Drogas , Antineoplásicos/uso terapêutico , Estudos Transversais , Neoplasias/tratamento farmacológico , Preparações Farmacêuticas
16.
Int J Cancer ; 154(8): 1335-1339, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-37962056

RESUMO

The incidence of cancer in general, including breast and prostate cancer specifically, is increasing in India. Breast and prostate cancers have genomic classifiers developed to guide therapy decisions. However, these genomic classifiers are often inaccessible in India due to high cost. These classifiers may also be less suitable to the Indian population, as data primarily from patients in wealthy Western countries were used in developing these genomic classifiers. In addition to the limitations in using these existing genomic classifiers, developing and validating new genomic classifiers for breast and prostate cancer in India is challenging due to the heterogeneity in the Indian population. However, there are steps that can be taken to address the various barriers that currently exist for accurate, accessible genomic classifiers for cancer in India.


Assuntos
Neoplasias da Mama , Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Mama/genética , Neoplasias da Mama/epidemiologia , Neoplasias da Próstata/genética , Neoplasias da Próstata/epidemiologia , Genômica , Índia/epidemiologia , Incidência
17.
Am J Cardiol ; 211: 326-333, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-37993040

RESUMO

This study aimed to compare the trends in cardiovascular diseases (CVDs)-related mortality in patients with Alzheimer's disease (AD) and in the general population aged ≥65 years. Data from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research Multiple Cause of Death dataset were used to determine national trends in age-adjusted CVD mortality rates (AAMR) and average annual percent change (AAPC) values in patients with AD and the overall population aged ≥65 years from 1999 to 2020. Data for AAMR and AAPCs were also stratified by age, gender, ethnicity/race, geographical region, urbanization status, and subgroups of CVD. Trends in the overall AAMR stratified by gender, age, ethnicity/race, geographical region, urbanization status, and CVD subgroups were statistically different between patients with AD and the overall population (overall AAPC for CVD mortality rate in patients with AD = -3.5% [confidence interval -4.1% to -2.9%] vs -2.6% [confidence interval -2.3% to -2.9%] in overall population, p = 0.01). Differences in the decrease in the mortality rates between patients with AD and the overall population were found to be statistically different across all stratifications except for the change in the mortality rates for hypertensive diseases (p = 0.05), females (p = 0.2), and Asian or Pacific Islanders (p = 0.09). In conclusion, CVD-related mortality in patients with AD decreased over the last 2 decades, and decreases were more prominent than seen in the general population aged ≥65 years. These results may help focus public health efforts to optimize CVD health in patients with AD.


Assuntos
Doença de Alzheimer , Doenças Cardiovasculares , Hipertensão , Feminino , Humanos , Doença de Alzheimer/epidemiologia , Doenças Cardiovasculares/mortalidade , Etnicidade , Hipertensão/mortalidade , Estados Unidos/epidemiologia , Grupos Raciais , Masculino , Idoso
18.
J Neurosurg Pediatr ; 32(6): 665-672, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-37724839

RESUMO

OBJECTIVE: Diffuse intrinsic pontine gliomas (DIPGs) are aggressive and malignant tumors of the brainstem. Stereotactic biopsy can obtain molecular and genetic information for diagnostic and potentially therapeutic purposes. However, there is no consensus on the safety of biopsy or effect on survival. The authors aimed to characterize neurological risk associated with and the effect of stereotactic biopsy on survival among patients with DIPGs. METHODS: A systematic review was performed in accordance with PRISMA guidelines to identify all studies examining pediatric patients with DIPG who underwent stereotactic biopsy. The search strategy was deployed in PubMed, Embase, and Scopus. The quality of studies was assessed using the Grading of Recommendations, Assessment, Development and Evaluation system, and risk of bias was evaluated with the Cochrane Risk of Bias in Nonrandomized Studies-of Interventions tool. Bibliographic, demographic, clinical, and outcome data were extracted from studies meeting inclusion criteria. RESULTS: Of 2634 resultant articles, 13 were included, representing 192 patients undergoing biopsy. The weighted mean age at diagnosis was 7.5 years (range 0.5-17 years). There was an overall neurosurgical complication rate of 13.02% (25/192). The most common neurosurgical complication was cranial nerve palsy (4.2%, 8/192), of which cranial nerve VII was the most common (37.5%, 3/8). The second most common complication was perioperative hemorrhage (3.6%, 7/192), followed by hemiparesis (2.1%, 4/192), speech disorders (1.6%, 3/192) such as dysarthria and dysphasia, and movement disorders (1.0%, 2/192). Hydrocephalus was less commonly reported (0.5%, 1/192), and there were no complications relating to wound infection/dehiscence (0%, 0/192) or CSF leak (0%, 0/192). No mortality was specifically attributed to biopsy. Diagnostic yield of biopsy revealed a weighted mean of 97.4% (range 91%-100%). Of the studies reporting survival data, 37.6% (32/85) of patients died within the study follow-up period (range 2 weeks-48 months). The mean overall survival in patients undergoing biopsy was 9.73 months (SD 0.68, median 10 months, range 6-13 months). CONCLUSIONS: Children with DIPGs undergoing biopsy have mild to moderate rates of neurosurgical complications and no excessive morbidity. With reasonably acceptable surgical risk and high diagnostic yield, stereotactic biopsy of DIPGs can allow for characterization of patient-specific molecular and genetic features that may influence prognosis and the development of future therapeutic strategies.


Assuntos
Neoplasias do Tronco Encefálico , Glioma Pontino Intrínseco Difuso , Glioma , Humanos , Criança , Lactente , Pré-Escolar , Adolescente , Glioma/patologia , Neoplasias do Tronco Encefálico/patologia , Biópsia/efeitos adversos
19.
Support Care Cancer ; 31(7): 420, 2023 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-37354234

RESUMO

In India, approximately 1.4 million new cases of cancer are recorded annually, with 26.7 million people living with cancer in 2021. Providing care for family members with cancer impacts caregivers' health and financial resources. Effects on caregivers' health and financial resources, understood as family and caregiver "financial toxicity" of cancer, are important to explore in the Indian context, where family members often serve as caregivers, in light of cultural attitudes towards family. This is reinforced by other structural issues such as grave disparities in socioeconomic status, barriers in access to care, and limited access to supportive care services for many patients. Effects on family caregivers' financial resources are particularly prevalent in India given the increased dependency on out-of-pocket financing for healthcare, disparate access to insurance coverage, and limitations in public expenditure on healthcare. In this paper, we explore family and caregiver financial toxicity of cancer in the Indian context, highlighting the multiple psychosocial aspects through which these factors may play out. We suggest steps forward, including future directions in (1) health services research, (2) community-level interventions, and (3) policy changes. We underscore that multidisciplinary and multi-sectoral efforts are needed to study and address family and caregiver financial toxicity in India.


Assuntos
Cuidadores , Neoplasias , Humanos , Cuidadores/psicologia , Família , Classe Social , Neoplasias/terapia , Índia
20.
Am J Med ; 136(7): 618-619, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36898599
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA