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1.
Clin Child Psychol Psychiatry ; : 13591045241286106, 2024 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-39293042

RESUMO

BACKGROUND: Severe mental disorders during childhood and adolescence can be chronic and disturbing, and may result in serious impairments in functioning. Research on the influence of such factors in the functional recovery of children diagnosed with severe mental illnesses is scant. This study aims to enhance understanding of the patterns and descriptions of social factors in the optimal functioning of children with severe mental illnesses. METHODS: We performed content analysis on 69 medical files of children taking treatment from Child and Adolescent Psychiatry (from 2018 to 2020). We analyzed the medical files using the summative approach by identifying and quantifying certain words and phrases. The Children's Global Assessment Scale (CGAS) and data abstraction form were used to record the functioning profile and quantitative data. Socio-demographic and clinical variables were analyzed using descriptive statistics. RESULTS: A total of three major and ten sub-categories were identified from the data. The most striking categories in psychosocial environments were intrapersonal challenges, adverse living and relationship spaces, and outer structures and systems. Moderate to severe functional impairments were retrospectively observed among children. CONCLUSION: Children diagnosed with severe mental illnesses and with poor functioning are the most affected group of population and hence, require proper attention.


In India, due to its diverse cultural, social environments and limited child mental health facilities, it becomes important to understand the factors which restrict the recovery and optimal functioning of children with severe mental illness and making use of that information clinical practice and developing interventions. Over the years, various research reports, papers and commissions have highlighted the relationship of social and cultural factors and mental disorders. However, very little has been done to study the interplay of psychosocial factors that affect the recovery and normal functioning of children with severe mental illness. To our best knowledge, this study is a first attempt to understand the psychosocial factors affecting the children with severe mental disorders based on qualitative content analysis of individual case files.

3.
Lupus ; 33(10): 1116-1129, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39148457

RESUMO

BACKGROUND: Neuropsychiatric systemic lupus erythematosus (NPSLE) is a poorly understood and heterogeneous manifestation of SLE. Common major NPSLE syndromes include strokes, seizures, myelitis, and aseptic meningitis. Easily obtainable biomarkers are needed to assist in early diagnosis and improve outcomes for NPSLE. A frequent end-result of major syndromes is neuronal or glial injury. Blood-based neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) have been utilized as markers for monitoring disease activity and/or severity in other neurodegenerative and neuroinflammatory diseases; however, they have not been evaluated in active major NPSLE. METHODS: This was a case-control study. We enrolled patients aged 12-60 years with active major NPSLE, SLE without active major NPSLE, and healthy controls. Active NPSLE was defined as being <6 months from last new or worsening neuropsychiatric symptom. Demographics, clinical data, and serum or plasma biosamples were collected. RESULTS: Thirteen patients with active major NPSLE, 13 age/sex/kidney function matched SLE controls without active major NPSLE, and 13 age/sex matched healthy controls (mean ages 26.8, 27.3, 26.6 years) were included. 92% of each group were female. Major syndromes included stroke (5), autonomic disorder (3), demyelinating disease (2), aseptic meningitis (2), sensorimotor polyneuropathy (2), cranial neuropathy (1), seizures (1), and myelopathy (2). Mean (standard deviation) blood NfL and GFAP were 3.6 pg/ml (2.0) and 50.4 pg/ml (15.0), respectively, for the healthy controls. Compared to healthy controls, SLE without active major NPSLE had mean blood NfL and GFAP levels 1.3 pg/ml (p = .42) and 1.2 pg/ml higher (p = .53), respectively. Blood NfL was on average 17.9 pg/ml higher (95% CI: 9.2, 34.5; p < .001) and blood GFAP was on average 3.2 pg/ml higher (95% CI: 1.9, 5.5; p < .001) for cases of active major NPSLE compared to SLE without active major NPSLE. In a subset of 6 patients sampled at multiple time points, blood NfL and GFAP decreased after immunotherapy. CONCLUSIONS: Blood NfL and GFAP levels are elevated in persons with SLE with active major NPSLE compared to disease matched controls and may lower after immunotherapy initiation. Larger and longitudinal studies are needed to ascertain their utility in a clinical setting.


Assuntos
Biomarcadores , Proteína Glial Fibrilar Ácida , Vasculite Associada ao Lúpus do Sistema Nervoso Central , Proteínas de Neurofilamentos , Humanos , Feminino , Biomarcadores/sangue , Estudos de Casos e Controles , Adulto , Masculino , Vasculite Associada ao Lúpus do Sistema Nervoso Central/sangue , Proteína Glial Fibrilar Ácida/sangue , Proteínas de Neurofilamentos/sangue , Adulto Jovem , Adolescente , Pessoa de Meia-Idade , Criança , Neuroglia/patologia , Neuroglia/metabolismo , Neurônios/patologia
4.
Continuum (Minneap Minn) ; 30(4): 1259-1271, 2024 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-39088295

RESUMO

ABSTRACT: As newer, innovative neurology drugs enter the US health care system, neurologists should consider the cost of these treatments in addition to their efficacy, safety, and tolerability. To do so thoughtfully requires an understanding of how prescription drugs are priced in the United States. The process of drug pricing is linked to the distribution supply chain and the many stakeholders involved. Stakeholders include pharmaceutical manufacturers; wholesalers; pharmacies; pharmacy benefit managers; payers, including health insurers; hospital systems; neurologists and other clinicians; and patients. Drug pricing has taken center stage as the Inflation Reduction Act of 2022 has set maximum out-of-pocket expenses for Medicare beneficiaries for the first time in the program's history and limits drug price increases for a select group of Medicare Part D drugs. This article describes the US drug distribution supply chain and its stakeholders and introduces key drug pricing terms; a brief description of how rebates are generally estimated will also be discussed. Finally, as newer neurology outpatient drugs enter the market, the "value" of drugs will be described through cost-effectiveness terminology and their utility for the clinical neurologist.


Assuntos
Custos de Medicamentos , Neurologistas , Humanos , Estados Unidos , Neurologistas/economia , Medicamentos sob Prescrição/economia
5.
Ann Clin Transl Neurol ; 11(6): 1526-1534, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38654416

RESUMO

OBJECTIVE: Our objectives were to (1) obtain the prevalence and demography of people with multiple sclerosis (MS) in a representative Colorado population, and (2) to assess the utilization of disease-modifying therapy within this prevalent cohort. METHODS: This is a retrospective, observational study of patients that had contact with the University of Colorado Health System from 2012 to 2020. We queried Health Data Compass, a data warehouse, for patient data and applied the MS Prevalence Workgroup Algorithm to generate a prevalent cohort. We calculated prevalence as of 31 December 2020, and stratified by age, sex, race, and ethnicity. Payer information and treatment exposure were obtained from linked claims from the Colorado All Payers Claim Database. Disease-modifying therapies were classified as highly effective and moderately effective based on the clinical trial, TREAT-MS (NCT03500328). RESULTS: From a population of 1,382,821 individuals, 8557 people with MS were captured. Age-adjusted prevalence of MS as of 31 December 2020 was 572.3 per 100,000 with a mean age of 47.36. Prevalence varied between demographic subgroups, with the lowest prevalence in Hispanic men (215.6) and highest in White (824.1) and Black women (820.1). Overall disease-modifying therapy exposure was 62.4%, with increased highly effective therapy use and a corresponding decrease in moderately effective therapy use on a yearly basis. INTERPRETATION: MS is highly prevalent in a representative Colorado cohort. Overall treatment and proportion of highly effective therapy exposure increased significantly during a critical period of MS therapeutic advances, indicating a shift in disease management driven sharply by the availability of on-label anti-CD20 therapy.


Assuntos
Esclerose Múltipla , Humanos , Masculino , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/terapia , Feminino , Adulto , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Colorado/epidemiologia , Adulto Jovem , Idoso , Adolescente , Estados Unidos/epidemiologia
6.
JCO Oncol Pract ; : OP2300576, 2024 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-38442311

RESUMO

PURPOSE: Randomized controlled trials have demonstrated that palliative care (PC) can improve quality of life and survival for outpatients with advanced cancer, but there are limited population-based data on the value of inpatient PC. We assessed PC as a component of high-value care among a nationally representative sample of inpatients with metastatic cancer and identified hospitalization characteristics significantly associated with high costs. METHODS: Hospitalizations of patients 18 years and older with a primary diagnosis of metastatic cancer from the National Inpatient Sample from 2010 to 2019 were analyzed. We used multivariable mixed-effects logistic regression to assess medical services, patient demographics, and hospital characteristics associated with higher charges billed to insurance and hospital costs. Generalized linear mixed-effects models were used to determine cost savings associated with provision of PC. RESULTS: Among 397,691 hospitalizations from 2010 to 2019, the median charge per admission increased by 24.9%, from $44,904 in US dollars (USD) to $56,098 USD, whereas the median hospital cost remained stable at $14,300 USD. Receipt of inpatient PC was associated with significantly lower charges (odds ratio [OR], 0.62 [95% CI, 0.61 to 0.64]; P < .001) and costs (OR, 0.59 [95% CI, 0.58 to 0.61]; P < .001). Factors associated with high charges were receipt of invasive medical ventilation (P < .001) or systemic therapy (P < .001), Hispanic patients (P < .001), young age (18-49 years, P < .001), and for-profit hospitals (P < .001). PC provision was associated with a $1,310 USD (-13.6%, P < .001) reduction in costs per hospitalization compared with no PC, independent of the receipt of invasive care and age. CONCLUSION: Inpatient PC is associated with reduced hospital costs for patients with metastatic cancer, irrespective of age and receipt of aggressive interventions. Integration of inpatient PC may de-escalate costs incurred through low-value inpatient interventions.

7.
Neurol Clin Pract ; 14(2): e200256, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38223350

RESUMO

A central approach to achieving high-quality neurologic care is to reduce the burden on providers in accessing services needed to achieve this level of care. Neurology-based practices across the continuum (solo, multispecialty, hospital, or health system-based) have adopted different methods to mitigate the impact of gatekeeper methods of prior authorization and related mechanisms. We discuss ways to partner with payers through innovative Gold Carding programs that reduce the burden of gatekeeper mechanisms on neurology providers, thereby allowing them to consistently focus their efforts in the provision of high-quality neurologic care.

8.
Expert Rev Pharmacoecon Outcomes Res ; 24(2): 171-180, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37961908

RESUMO

INTRODUCTION: The United States has begun assessing the value of pharmaceuticals to inform negotiated prices in the Medicare program. Given strong political objections in the United States to the use of QALYs, Medicare will need to adopt an alternative approach to measuring value. AREAS COVERED: In this narrative review, we identified six alternative approaches to measuring value (equal value life-years, health years in total, generalized risk-adjusted cost-effectiveness, severity weighting based on absolute or proportional shortfall, comparative effectiveness based on conventional clinical endpoints, and comparative effectiveness based on both conventional endpoints and patient-centric value elements) and five criteria for assessing these approaches (responsiveness to concerns about discrimination, feasibility, transparency, flexibility, and the ability to incorporate factors beyond traditional value elements). EXPERT OPINION: Four of the alternatives are broadly aligned with the cost-effectiveness framework, but none fully addresses all aspects of the stated concerns that QALYs may be used to unintentionally implement discrimination. We note, however, that the extent to which these concerns lead to discrimination in practice is unknown. Finally, we recommend an approach for measuring value in terms of comparative effectiveness that combines quantitative ranking and weighting of distinct criteria (including patient-centric value elements) with deliberation.


Assuntos
Medicare , Negociação , Idoso , Humanos , Estados Unidos , Anos de Vida Ajustados por Qualidade de Vida , Análise Custo-Benefício
9.
Cancer Med ; 12(18): 18729-18744, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37706222

RESUMO

BACKGROUND: The National Comprehensive Cancer Network suggested that older women with low-risk breast cancer (LRBC; i.e., early-stage, node-negative, and estrogen receptor-positive) could omit adjuvant radiation treatment (RT) after breast-conserving surgery (BCS) if they were treated with hormone therapy. However, the association between RT omission and breast cancer-specific mortality among older women with comorbidity is not fully known. METHODS: 1105 older women (≥65 years) with LRBC in 1998-2012 were queried from the Surveillance, Epidemiology, and End Results-Medicare Health Outcomes Survey data resource and were followed up through July 2018. Latent class analysis was performed to identify comorbidity burden classes. A propensity score-based inverse probability of treatment weighting (IPTW) was applied to Cox regression models to obtain subdistribution hazard ratios (HRs) and 95% CI for cancer-specific mortality considering other causes of death as competing risks, overall and separately by comorbidity burden class. RESULTS: Three comorbidity burden (low, moderate, and high) groups were identified. A total of 318 deaths (47 cancer-related) occurred. The IPTW-adjusted Cox regression analysis showed that RT omission was not associated with short-term, 5- and 10-year cancer-specific death (p = 0.202 and p = 0.536, respectively), regardless of comorbidity burden. However, RT omission could increase the risk of long-term cancer-specific death in women with low comorbidity burden (HR = 1.98, 95% CI = 1.17, 3.33), which warrants further study. CONCLUSIONS: Omission of RT after BCS is not associated with an increased risk of cancer-specific death and is deemed a reasonable treatment option for older women with moderate to high comorbidity burden.


Assuntos
Neoplasias da Mama , Feminino , Idoso , Humanos , Estados Unidos/epidemiologia , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/radioterapia , Resultado do Tratamento , Estadiamento de Neoplasias , Programa de SEER , Medicare , Radioterapia Adjuvante , Mastectomia Segmentar , Comorbidade
10.
Neurology ; 101(11): e1167-e1177, 2023 09 12.
Artigo em Inglês | MEDLINE | ID: mdl-37487753

RESUMO

BACKGROUND AND OBJECTIVES: The objective of this study was to determine the external validity of the Axon Registry by comparing the 2019 calendar year data with 2 nationally representative, publicly available data sources, specifically the National Ambulatory Medical Care Survey (NAMCS) and the Medical Expenditure Panel Survey (MEPS). The Axon Registry is the American Academy of Neurology's neurology-focused qualified clinical data registry that reports and analyzes electronic health record data from participating US neurology providers. Its key function is to support quality improvement within ambulatory neurology practices while also promoting high-quality evidence-based care in clinical neurology. We compared demographics of patients who had an outpatient or office visit with a neurologist along with prevalence of selected neurologic conditions and neurologic procedures across the 3 data sets. METHODS: We performed a cross-sectional, retrospective comparison of 3 data sets: NAMCS (2012-2016), MEPS (2013-2017, 2019), and Axon Registry (2019). We obtained patient demographics (age, birth sex, race, ethnicity), patient neurologic conditions (headache, epilepsy, cerebrovascular disease, multiple sclerosis, parkinsonism, dementia, spinal pain, and polyneuropathy), provider location, and neurologic procedures (neurology visits, MR/CT neuroimaging studies and EEG/EMG neurophysiologic studies). Parameter estimates from the pooled 5-year samples of the 2 public data sets, calculated at the visit level, were compared descriptively with those of the Axon Registry. We calculated Cohen h and performed Wald tests (α = 0.05) to conduct person-level statistical comparisons between MEPS 2019 and Axon Registry 2019 data. RESULTS: The Axon Registry recorded 1.3 M annual neurology visits (NAMCS, 11 M; MEPS, 22 M) and 645 K people with neurologic conditions (MEPS, 10 M). Compared with the pooled national surveys, the Axon Registry has similar patient demographics, neurologic condition prevalence, neuroimaging and neurophysiologic utilization, and provider location. In direct comparison with MEPS 2019, the Axon Registry 2019 had fewer children (2% vs 7%), more elderly persons (21% vs 16%), fewer non-Black and non-White race persons (5% vs 8%), less number of patients with epilepsy (10% vs 13%), more patients with dementia (8% vs 6%), more patients with cerebrovascular disease (11% vs 8%), and a greater predominance of neurology providers in the Midwest (25% vs 20%). The only difference with a non-negligible effect size was the proportion of people younger than 15 years (Cohen h = 0.25). DISCUSSION: The Axon Registry demonstrates high concordance with 2 nationally representative surveys. Recruiting more and diverse neurology providers will further improve the volume, representativeness, and value of the Axon Registry.


Assuntos
Demência , Doenças do Sistema Nervoso , Neurologia , Criança , Humanos , Estados Unidos/epidemiologia , Idoso , Estudos Transversais , Estudos Retrospectivos , Doenças do Sistema Nervoso/epidemiologia , Doenças do Sistema Nervoso/terapia , Pesquisas sobre Atenção à Saúde , Sistema de Registros , Assistência Ambulatorial
11.
12.
J Phys Chem A ; 127(16): 3675-3683, 2023 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-37043375

RESUMO

Interatomic potentials for the B2Σ1/2+ states of CsAr, CsXe, and RbXe have been determined through comparisons of experimental B ← X absorption spectra for alkali vapor-rare gas mixtures with calculations of the Franck-Condon factors (FCFs) associated with free-free transitions of thermal atomic pairs. Simulations of optical transitions of alkali-rare gas atomic pairs between the thermal and vibrational continua of the X2Σ1/2+ and B2Σ1/2+ states of the molecule, responsible for the blue satellites of the Cs and Rb D2 resonance lines in a rare gas background, require the incorporation of ground-state J values above ∼400 into the FCF calculations and proper normalization of the free-particle wave functions. Absorption spectra computed on the basis of several X and B state interatomic potentials available in the literature were found to be sensitive to the height of the B2Σ1/2+ state barrier, as well as the X2Σ1/2+ state repulsive wall contour and the location of the van der Waals minimum. Other spectral simulations entailed iterative modifications to a selected B2Σ1/2+ interatomic potential, again coupled with comparison to experimental B ← X spectra. Comparisons of calculated spectra with experiment yield a CsXe B2Σ1/2+ potential, for example, exhibiting a barrier height of 76 cm-1 at 5.2 Å and yet is nearly flat at smaller values of internuclear separation (R). The latter contrasts with previous theoretical calculations of VB(R) in the vicinity of the barrier maximum. For the CsAr molecule, the B2Σ1/2+ barrier height was found to be 221 cm-1, which is within 3% of the value determined from pseudopotential calculations incorporating the spin-orbit effect. Reproducing Cs-rare gas experimental absorption spectra also requires the existence of a broad, shallow potential well lying beyond the B2Σ1/2+ barrier that, for CsAr, has a dissociation energy (De ∼ 24 cm-1) a factor of 3 larger than values predicted by theory. Similar results are obtained for the RbXe and CsXe complexes.

13.
J Med Econ ; 26(1): 494-502, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36970763

RESUMO

AIM: Evaluate the real-world costs over two years and costs by site of care for ocrelizumab (OCR), natalizumab (NTZ), and alemtuzumab (ATZ) in patients with multiple sclerosis (MS). METHODS: This retrospective study used HealthCore Integrated Research Database and included continuously enrolled adults with MS initiating OCR, NTZ, and ATZ between April 2017 and July 2019 (i.e. patient identification period). Annual total cost of care (pharmacy and medical costs) was evaluated for the first- and second-year of follow-up, further stratified by site of care. Costs were measured using health plan allowed amount and adjusted to 2019 US dollars. Sensitivity analyses were conducted in patients who completed yearly dosing schedule according to Food and Drug Administration approved prescribing information. RESULTS: Overall, 1,058, 166, and 46 patients were included in OCR, NTZ, and ATZ cohorts, respectively. Mean (standard deviation [SD]) total cost of care during first- and second-year follow-up were $125,597 ($72,274) and $109,618 ($75,085) for OCR, $117,033 ($57,102) and $106,626 ($54,872) for NTZ, and $179,809 ($97,530) and $108,636 ($77,973) for ATZ. Infusible drug cost was the main driver in all three cohorts accounting for >78% of the total costs. Annual total cost of care increased substantially after patients started/switched to infusible DMTs. Across site of care, hospital outpatient infusion was common (OCR 58%, NTZ 37%, ATZ 49%) and expensive followed by physician office infusion (OCR 28%, NTZ 40%, ATZ 16%); home infusion was the least common (<10%) and least expensive. LIMITATIONS: The results were limited to commercially insured patients (specifically those with Anthem-affiliated health plans). CONCLUSIONS: Real-world costs increased after patients started/switched to infusible DMTs. Drug cost is the main driver for the total costs, which varied substantially by site of care. Controlling drug cost markups and using home setting for infusion can reduce costs in the treatment of MS patients.


Ocrelizumab (OCR), natalizumab (NTZ), and alemtuzumab (ATZ) are infusible drugs to treat patients with multiple sclerosis (MS). We did a study to understand the costs of these infusible MS drugs in real-world settings by analyzing a patients' pharmacy and medical claims database. A total of 1,058 patients were included. We found that the annual total costs increased substantially after patients started to use these infusible MS drugs. Specifically, the average first- and second-year total costs for patients were $125,597 and $109,618 for OCR, $117,033 and $106,626 for NTZ, and $179,809 and $108,636 for ATZ, respectively. We also found that the cost of the drug itself is the main driver for the overall healthcare spending, accounting for >78% of the total costs. Additionally, we found that the cost varies depending on where patients receive these infusible MS drugs, and generally speaking, infusions received from hospital outpatient settings would be more expensive than received from home settings. In summary, this study showed that the real-world costs of these infusible MS drugs are very high. Shifting patients away from more costly hospital outpatient departments or using MS drugs that do not require infusion resources (e.g. oral/self-injectable) may help reduce the overall healthcare spending on MS.


Assuntos
Esclerose Múltipla , Adulto , Humanos , Esclerose Múltipla/tratamento farmacológico , Estudos Retrospectivos , Natalizumab/uso terapêutico , Custos de Medicamentos , Alemtuzumab/uso terapêutico
14.
Semin Radiat Oncol ; 33(2): 211-217, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36990638

RESUMO

Radiotherapy (RT) plays a critical role in the palliation of symptoms in patients with advanced or metastatic cancer. To address the growing need for these services, multiple dedicated palliative RT programs have been established. This article serves to highlight the novel ways in which palliative RT delivery systems support patients with advanced cancer. Through early integration of multidisciplinary palliative supportive services, rapid access programs facilitate best practices for oncologic patients at the end of life.


Assuntos
Neoplasias , Radioterapia (Especialidade) , Humanos , Cuidados Paliativos , Neoplasias/radioterapia , Oncologia
15.
Ann Clin Transl Neurol ; 10(4): 579-588, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36811392

RESUMO

OBJECTIVE: This study aimed to evaluate safety (infusion-related reactions [IRRs]) and patient satisfaction (patient-reported outcomes [PROs]) for at-home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open-label study included adult patients with an MS diagnosis who had completed a ≥ 600-mg ocrelizumab dose, had a patient-determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600-mg ocrelizumab home-based infusion over 2 h, followed by 24-h and 2-week post-infusion follow-up calls. IRRs and adverse events (AEs) were documented during infusions and follow-up calls. PROs were completed before and 2 weeks post infusion. RESULTS: Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)-similar to other shorter ocrelizumab infusion studies-and all AEs were mild/moderate. In total, 66.7% of patients experienced AEs, including itch, fatigue, and grogginess. Patients reported significantly increased satisfaction with the at-home infusion process and confidence in the care provided. Patients also reported a significant preference for at-home infusion compared with prior infusion center experiences. INTERPRETATION: IRRs and AEs occurred at acceptable rates during in-home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home-based ocrelizumab infusion over a shorter infusion period.


Assuntos
Esclerose Múltipla , Adulto , Feminino , Humanos , Masculino , Anticorpos Monoclonais Humanizados , Infusões Intravenosas , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/etiologia , Avaliação de Resultados da Assistência ao Paciente
16.
Pharmacoecon Open ; 7(2): 217-228, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36316575

RESUMO

BACKGROUND AND OBJECTIVE: Several novel methods have been suggested to extend a conventional value assessment to capture a more comprehensive perspective of value from a patient perspective. The objective of this research was to demonstrate a framework for implementing a combined qualitative and quantitative method to elicit and prioritize patient experience value elements in rare diseases. Neuromyelitis optica spectrum disorder was used as a case study. METHODS: The method for eliciting and prioritizing patient experience value elements involved a three-step process: (1) collecting potential patient experience value elements from existing literature sources followed by deliberation by a multi-stakeholder research team; (2) a pre-workshop webinar and survey to identify additional patient-reported value elements; and (3) a workshop to discuss, prioritize the value elements using a swing weighting method. Outcomes were prioritized value elements with normalized weights for patients considering a treatment for neuromyelitis optica spectrum disorder. RESULTS: A literature review and deliberation resulted in the following initial value elements: ability to reach important personal milestones, patient's financial burden, value of hope/balance or timing of risks and benefits, Uncertainty about long-term benefits and safety of the treatment, Patient empowerment through therapeutic advancement and technology, Caregiver/family's financial burden, patient experience related to treatment regimen, Therapeutic options, and Caregiver/family's quality of life. Eight patients with neuromyelitis optica spectrum disorder participated in the case study. In the online survey, participants found the nine proposed patient experience value elements both understandable and important with no additions. During the workshop, 'Uncertainty about long-term benefits and safety,' 'Patient experience related to treatment regimen,' and 'Patient's financial burden' were found to be the most important patient experience value elements, with a respective weight of 25%, 19.2%, and 14.4% (out of total 100%). CONCLUSIONS: This case study provides a framework for eliciting and prioritizing patient experience value elements using direct patient input. Although elements/weights may differ by disease, and even in neuromyelitis optica spectrum disorder, additional research is needed, value frameworks, researchers, and manufacturers can use this practical method to generate patient experience value elements and evaluate their impact on treatment selection.

17.
Pract Radiat Oncol ; 13(3): e220-e229, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36526246

RESUMO

PURPOSE: Education and specific training on serious illness communication skills for radiation oncology residents is lacking. The Accreditation Council for Graduate Medical Education requires radiation oncology residents to demonstrate interpersonal and communication skills; however, implementing specific training to address this poses an ongoing challenge. This study assesses the feasibility and effectiveness of a radiation oncology specific serious illness communication curriculum at a single radiation oncology residency program. METHODS AND MATERIALS: The primary objectives were to assess observable communication skills among radiation oncology residents and their perceived level of preparedness and comfort with patient encounters surrounding serious illness. Each resident participated in a baseline simulated patient encounter. Two virtual half-day experience-based learning sessions led by faculty experts trained in teaching serious illness communication were held. The training consisted of brief didactic teaching, with the emphasis on small group guided practice with simulated patients in scenarios specific to radiation oncology. Each resident participated in a postcourse simulated patient encounter. Three blinded faculty trained in serious illness communication completed objective assessments of observable communication skills to compare pre- and postcourse performance. RESULTS: A t test based on validated assessments reviewed by blinded faculty demonstrated significant improvement in overall observable communication skills among radiation oncology residents in the postcourse encounter compared with the precourse encounter (P = .0067). Overall, 8 of 9 (89%) residents felt more comfortable and prepared with radiation oncology-specific serious illness communication after the course compared with prior. The simulated patients rated the overall average resident performance higher on the postcourse assessment (Likert 4.89/5) compared with the precourse assessment (Likert 4.09/5), which trended toward a significant improvement (P = .0515). CONCLUSIONS: Radiation oncology residents had a significant improvement in observable communication skills after participating in an experience-based training curriculum. This course can serve as an adaptable model that may be implemented by other radiation oncology residency programs.


Assuntos
Internato e Residência , Radioterapia (Especialidade) , Humanos , Educação de Pós-Graduação em Medicina , Currículo , Comunicação , Competência Clínica
18.
Am J Manag Care ; 28(16 Suppl): S323-S328, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36548523

RESUMO

Multiple sclerosis (MS) is a chronic, immune-mediated, neurodegenerative condition that results in progressive accumulation of disability over the course of the disease. MS presents heterogeneously, and, as the disease progresses, patients develop a range of physical and neurologic problems that include reduced mobility, cognitive impairment, weakness, fatigue, pain, and defects in speech or vision. Economically, MS is costly, including both direct costs stemming from clinical care and medications and the indirect costs of productivity losses. These costs pose a substantial burden to patients, families, caregivers, employers, and society. There are 21 approved disease-modifying therapies for MS across several drug classes. The importance of early MS treatment has been confirmed, and progress has been made in the treatment of relapsing-remitting MS, although this progress has not been replicated for progressive presentations of the disease. Ongoing research continues to elucidate the exact mechanisms of disease in MS as well as potential new treatment strategies that may better address current gaps, such as disability progression in secondary progressive MS without activity. One of the novel pathways under investigation is the inhibition of Bruton tyrosine kinase, a cytoplasmic tyrosine kinase, which is expressed in B cells and other potentially targetable hematopoietic lineage cells. This review examines emerging hypotheses that targeting both B cells and myeloid cells within the periphery and central nervous system could yield clinical effects in key areas of MS pathophysiology that are currently unaddressed.


Assuntos
Tirosina Quinase da Agamaglobulinemia , Esclerose Múltipla , Humanos , Tirosina Quinase da Agamaglobulinemia/antagonistas & inibidores , Tirosina Quinase da Agamaglobulinemia/metabolismo , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/enzimologia , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/enzimologia , Redes e Vias Metabólicas , Linfócitos B/efeitos dos fármacos , Linfócitos B/enzimologia , Células Mieloides/efeitos dos fármacos , Inibidores de Proteínas Quinases/farmacologia , Inibidores de Proteínas Quinases/uso terapêutico
19.
Neurol Clin Pract ; 12(2): 169-175, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35733944

RESUMO

Aducanumab (Aduhelm), developed by the biotechnology firm Biogen in Cambridge, MA, was approved using the less common accelerated approval pathway by the Federal Drug Administration (FDA) reserved for treatments that fill a significant unmet need.1 Its approval on June 7, 2021, has been met with an outpouring of opinions from prescribers, insurers, advocacy groups, and hospital systems regarding its risk-benefit profile.2-4 Originally approved for all forms of Alzheimer disease (AD), the FDA updated aducanumab's labeling on July 8, 2021, for "treatment in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials."5 With 6 million people nationally in the United States who suffer from AD and an anticipated one-third of those who may now fulfill the criteria under the revised labeling, the implications of aducanumab's approval continue to generate national interest.6.

20.
Mult Scler Relat Disord ; 61: 103784, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35405561

RESUMO

BACKGROUND: Despite advances in algorithms for identifying people with MS (PwMS) in large data sets, limited data exists on regional prevalence, or prevalence and care in minority populations. OBJECTIVES: To report the 7-year (01/01/2012-12/31/2018) prevalence and demographics of MS and disease-modifying therapy (DMT) utilization in a large, diverse population. METHODS: This retrospective analysis used the OneFlorida Data Trust, which captures health data from >15 million Floridians across 10 constituent organizations. A validated algorithm identified subjects with MS. DMTs were identified using RxNorm concept unique identifiers and National Drug Codes. Results were stratified across age, sex, race-ethnicity, and location. RESULTS: Of 6,638,649 adults in the database, the algorithm identified 9681 PwMS. Overall prevalence per 100,000 was 145.83. MS prevalence was considerable in women of all races and ethnicities ranging from 138.86 to 253.76 per 100,000. 52.6% of PwMS had one or more DMT prescription. DMT prescription was more likely in Hispanic PwMS. CONCLUSION: Prevalence analysis of the OneFlorida Data Trust revealed a substantial burden of disease in women of all races and ethnicities. Variation in treatment utilization among demographic subgroups underscores the need for additional studies to assess health care disparities in MS at the population level.


Assuntos
Esclerose Múltipla , Adulto , Etnicidade , Feminino , Humanos , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/epidemiologia , Prevalência , Estudos Retrospectivos
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