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Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation.

OBJECTIVE: To evaluate the survival gains and additional Medicare spending associated with early access to new cancer drugs granted accelerated approval by the US Food and Drug Administration (FDA), compared with access to cancer drugs following completion of confirmatory trials. DESIGN: Retrospective observational study and economic evaluation. SETTING: US Medicare programme, which provides health insurance for adults aged 65 years and older. PARTICIPANTS: Medicare beneficiaries who received new cancer drug indications from the time of FDA accelerated approval to conversion to regular appr

The Efficacy of Digital Interventions on Adherence to Oral Systemic Anticancer Therapy Among Patients With Cancer: Systematic Review and Meta-Analysis.

BackgroundDigital interventions have been increasingly applied in multidisciplinary care plans to improve medication adherence to oral systemic anticancer therapy (SACT), the crucial lifesaving treatments for many cancers. However, there is still a lack of consensus on the efficacy of those digital interventions.objectivesThis systematic review and meta-analysis aimed to investigate the efficacy of digital interventions in improving adherence to oral SACTs in patients with cancer.MethodsThis systematic review and meta-analysis followed the PRISMA (Preferred Reporting Items for Systematic Revie

Patient Engagement in Oncology Practice: A Qualitative Study on Patients' and Nurses' Perspectives.

Patient engagement has gained increasing attention in cancer care as it is widely acknowledged as an essential element of high-quality care. There are limited data on how oncology nurses might apply techniques that encourage patient engagement. Therefore, this study aims to understand which nursing strategies can favour patient engagement in oncological care from patients' and nurses' perspectives. We conducted a qualitative study involving oncology patients and oncology nurses. Patients were interviewed, while nurses were involved in focus groups (FGs). Both interviews and FGs were analysed b

Применение телемедицины в лечении усталости пациентов с множественным склерозом: обзор аналитического исследования.

Усталость является распространенным симптомом у людей с множественным склерозом, однако доказательства эффективности телемедицины в лечении этого симптома остаются неполными. Несмотря на положительные результаты клинических испытаний, его учет в практической деятельности и систематическая оценка являются ограниченными. ЦЕЛЬ: Цель этого исследовательского проекта заключается в тщательной оценке того, насколько хорошо телемедицина помогает пациентам, страдающим от усталости. МЕТОДЫ: Этот аналитический обзор проводился в соответствии с методологической основой Института Джоанны Бриггс и с учетом

Efficacy and safety of acupuncture for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis of randomized controlled trial.

OBJECTIVE: Chemotherapy-induced nausea and vomiting (CINV) represents a common and debilitating side effects in cancer patients, often compromising treatment adherence and quality of life. Current management remains suboptimal, necessitating the exploration of complementary therapies. Acupuncture, as a widely used adjunctive therapy, has been attempted for the treatment of CINV. This study aims to systematically evaluate the effect and safety of acupuncture in managing CINV. METHODS: We comprehensively searched seven electronic databases (EMBASE, Cochrane Library, Web of Science, PubMed, Chin

Pharmacomicrobiomics in Anticancer Therapies: Why the Gut Microbiota Should Be Pointed Out.

Anticancer treatments have shown a variable therapeutic outcome that may be partly attributable to the activity of the gut microbiota on the pathology and/or therapies. In recent years, microbiota-drug interactions have been extensively investigated, but most of the underlying molecular mechanisms still remain unclear. In this review, we discuss the relationship between the gut microbiota and some of the most commonly used drugs in oncological diseases. Different strategies for manipulating the gut microbiota layout (i.e., prebiotics, probiotics, antibiotics, and fecal microbiota transplantati

Mutation profile and chromosomal abnormality in adenomyosis.

In briefBy tissue-selective next-generation sequencing, we showed that adenomyotic epithelium harbored genomic alterations thought to be relevant to the development and progression of adenomyosis, including somatic mutations in several cancer-associated genes with high mutant allele frequencies and the gain of chromosome 1q. Clonal relationships among multiple adenomyotic lesions and the normal uterine endometrium delineate the oligoclonal origin of adenomyosis and the spatial expansion of mutant clones.AbstractTo identify the distinctive features of mutation profiles in adenomyosis compared t

Integration of Chronic Oncology Services in Noncommunicable Disease Clinic in Rural Rwanda.

BackgroundIn rural sub-Saharan Africa, access to care for severe non-communicable diseases (NCDs) is limited due to myriad delivery challenges. We describe the implementation, patient characteristics, and retention rate of an integrated NCD clinic inclusive of cancer services at a district hospital in rural Rwanda.MethodsIn 2006, the Rwandan Ministry of Health at Rwinkwavu District Hospital (RDH) and Partners In Health established an integrated NCD clinic focused on nurse-led care of severe NCDs, within a single delivery platform. Implementation modifications were made in 2011 to include cance

Совпадение в полном тексте источника
… Implementation Science for Global Oncology: The Imperative to Evaluate the Safety and Efficacy of Cancer Care Delivery . J Clin Oncol . 2016 ; 34 ( 1 ): 43 – 52 . DOI: 10.1200/JCO.2015.61.7738 26578617 …

Establishing a successful outpatient CAR T-Cell program with cilta-cel: real-world experience from an expert roundtable.

In less than a decade since their first approval, chimeric antigen receptor T-cell (CAR-T) therapies have moved into earlier lines of therapy, shifting administration from an inpatient to an outpatient setting and increasing patient demand. Several CAR-T outpatient programs have been initiated to meet patient and institution needs, resulting in resource conservation, increased treatment capacity, reduced hospitalization times, and financial advantages. Ciltacabtagene autoleucel (cilta-cel) is uniquely suited for outpatient administration, given its predictably delayed cytokine release syndrome

Обоснование 4-month, параллельные, выборочно контролируемые испытания для оценки осуществимости и эффективности дистанционного обучения испаноязычных/латиноязычных лиц с множественным склерозом (FERLA MS).

ИСТОРИЯ ВОПРОСА: Испаноязычные/латиноязычные лица с множественным склерозом (МС) сталкиваются с бóльшим бременем болезней и коморбидностью из-за ограниченного доступа к медицинскому обслуживанию, недостаточной представленности в научных исследованиях и социальных факторов, определяющих состояние здоровья (SDOH). Профессиональная подготовка могла бы способствовать достижению результатов в области здравоохранения, однако в существующих исследованиях, посвященных мерам вмешательства, не представлены испаноязычные/латиноязычные страны. МЕТОДЫ: Мы предлагаем провести технико-экономическое обоснован

Interventions to improve cancer survivorship among Indigenous Peoples and communities: a systematic review with a narrative synthesis.

PurposeThe purpose of this systematic review is to synthesize the evidence on the types of interventions that have been utilized by Indigenous Peoples living with cancer, and report on their relevance to Indigenous communities and how they align with holistic wellness.MethodsA systematic review with narrative synthesis was conducted.ResultsThe search yielded 7995 unique records; 27 studies evaluating 20 interventions were included. The majority of studies were conducted in USA, with five in Australia and one in Peru. Study designs were cross-sectional (n=13); qualitative (n=5); mixed methods (

Leveraging the bacteria for enhanced cancer immunotherapy: from a perspective of synthetic biology.

In recent years, synthetic biology has been widely applied to engineer and program cellular behaviors. Using this approach, bacteria can be designed to express immunotherapeutic agents, improve tumor targeting, and deliver therapeutic payloads directly to tumor sites. To further improve efficacy, strategies such as hypoxia-responsive promoters, bacterial swarming, and extracellular vesicles (EVs) have been investigated, along with the synergistic effects of combining bacterial therapy with other treatments (e.g., photodynamic therapy, chemotherapy, immune checkpoint inhibitors). This review su

Многомерное профилирование и модели риска, основанные на клиническом развертывании АИ, в МГУС и миеломе.

Моноклональная гаммопатия неопределённого значения (MGUS), храпающая миелома (SMM) и множественная миелома (MM) образуют континуум расстройств плазменных клеток, причем прогрессировать от MGUS до MM трудно предсказать. Нынешние модели стратификации риска, в значительной степени основанные на клинических, лабораторных и цитогенетических маркерах, не отражают молекулярную сложность, лежащую в основе развития заболеваний, что ограничивает их прогнозную точность. Последние достижения в области мультиомики, включая геномику, транскриптомику, протеомику и метаболомику, позволили глубже понять молеку

Национальное обследование использования медицинских ресурсов для лечения раковых заболеваний с использованием данных о состоянии здоровья населения Японии 2011 в адрес 2022.

Многодисциплинарное лечение рака значительно продвинулось вперед, особенно в том, что касается молекулярной целевой терапии, способствующей прогнозированию. Хотя эти расходы являются дорогостоящими, их финансовые последствия остаются непроверенными. Цель этого исследования заключалась в изучении общего использования ресурсов здравоохранения и выявлении факторов, определяющих стоимость лечения рака в Японии. В этом ретроспективном когортном исследовании пациенты диагностировали недуги в период с апреля 2011 и март 2022 были классифицированы по типам раковых заболеваний, и были проанализированы

Ten years of AMNOG from an oncological perspective: new horizons and continuing expansion.

Purpose2021 marks the tenth anniversary of the AMNOG process and brought with it a new German administration-two good reasons to take stock of where we stand today, what has been achieved so far, and how the path of early benefit assessments in Germany should continue.ResultsFrom the perspective of manufacturers of cancer drugs, the AMNOG process, as a constantly evolving system, has for the most part proved itself-which does not mean that there is no longer room for improvement. Significant improvements have been achieved in the area of early consultation of medical societies regarding the se

Chimeric antigen receptor T-cell therapy: Challenges and framework of outpatient administration.

Adoptive cellular therapy has made a landmark change within the treatment paradigm of several hematologic malignancies, and novel cellular therapy products, such as chimeric antigen receptor T-cell therapy (CART), have demonstrated impressive efficacy and produced durable responses. However, the CART treatment process is associated with significant toxicities, healthcare resource utilization, and financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile. Improved toxicity management strategies and a better understanding of cellular

The effectiveness of mandala coloring on the psychological and physiological symptoms in adult hospitalized patients: a meta-analysis.

BackgroundHospitalization often imposes significant psychological and physiological demands on patients. Mandala coloring may help reduce these challenges. This meta-analysis aimed to evaluate the effectiveness of mandala coloring interventions across psychological and physiological symptoms in adult hospitalized patients.MethodsA comprehensive search was conducted using nine databases. Randomized controlled and controlled studies comparing mandala coloring with control groups were included. Data extraction was performed independently by two authors, and risk of bias was assessed using the Coc

Redefining Breast Cancer Care by Harnessing Computational Drug Repositioning.

Breast cancer faces significant therapeutic challenges, particularly for triple-negative breast cancer (TNBC), due to limited targeted therapies and drug resistance. Drug repositioning leverages existing safety and pharmacokinetic data to expedite the identification of new indications with cost-effective benefits compared to de novo drug discovery. In this critical narrative review, we examine recent advances in computational repositioning strategies for breast cancer, focusing on network-based methods, computer-aided drug design, artificial intelligence and machine learning, transcriptomic si

Early shift to oral antibiotic treatment for pyogenic vertebral osteomyelitis (SAVE): study protocol for an open label, non-inferiority, nation-wide randomized controlled clinical trial.

BACKGROUND: The current Danish National Guideline (DNG) for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week is non-inferior to the current DNG. METHODOLOGY: The SAVE trial is an investigator initiated, randomized (1:1), controlled, non-inf

Stakeholder Perceptions of Key Aspects of High-Quality Cancer Care to Assess with Patient Reported Outcome Measures: A Systematic Review.

Performance measurement is the process of collecting, analyzing, and reporting standardized measures of clinical performance that can be compared across practices to evaluate how well care was provided. We conducted a systematic review to identify stakeholder perceptions of key symptoms and health domains to test as patient-reported performance measures in oncology. Stakeholders included cancer patients, caregivers, clinicians, and healthcare administrators. Standard review methodology was used, consistent with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). MEDLIN

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… Using an implementation science approach to implement and evaluate patient-reported outcome measuRes. (PROM) initiatives in routine care settings. Qual. Life Res. 2020 doi: 10.1007/s11136-020-02564-9. 67. …