21 research outputs found
Evaluating the Effectiveness and Cost-Effectiveness of Seizure Dogs in Persons With Medically Refractory Epilepsy in the Netherlands
__Background:__ Epilepsy is associated with a high disease burden, impacting the lives of
people with epilepsy and their caregivers and family. Persons with medically refractory
epilepsy experience the greatest burden, suffering from profound physical, psychological,
and social consequences. Anecdotal evidence suggests these persons may benefit
from a seizure dog. As the training of a seizure dog is a substantial investment,
their accessibility is limited in the absence of collective reimbursement as is seen
in the Netherlands. Despite sustained interest in seizure dogs, scientific knowledge
on their benefits and costs remains scarce. To substantiate reimbursement decisions
stronger evidence is required. The EPISODE study aims to provide this evidence
by evaluating the effectiveness and cost-effectiveness of seizure dogs in adults with
medically refractory epilepsy.
__Methods:__ The study is designed as a stepped wedge randomized controlled trial that
compares the use of seizure dogs in addition to usual care, with usual care alone. The
study includes adults with epilepsy for whom current treatment options failed to achieve
seizure freedom. Seizure frequency of participants should be at least two seizures per
week, and the seizures should be associated with a high risk of injury or dysfunction.
During the 3 year follow-up period, participants receive a seizure dog in a randomized
order. Outcome measures are taken at multiple time points both before and after receiving
the seizure dog. Seizure frequency is the primary outcome of the study and will be
recorded continuously using a seizure diary. Questionnaires measuring seizure severity,
quality of life, well-being, resource use, productivity, social participation, and caregiver
burden will be completed at baseline and every 3 months thereafter. The study is
designed to include a minimum of 25 participants.
__Discussion:__ This protocol describes the first randomized controlled trial on seizure
dogs. The study will provide comprehensive data on the effectiveness and cost effectiveness
of seizure dogs in adults with medically refractory epilepsy. Broader benefits
of seizure dogs for persons with epilepsy and their caregivers are taken into account,
as well as the welfare of the dogs. The findings of the study can be used to inform
decision-makers on the reimbursement of seizure dogs
Erratum:The behavioral and psychological symptoms of dementia in down syndrome scale (BPSD-DS II): Optimization and further validation
BACKGROUND: People with Down syndrome (DS) are at high risk to develop Alzheimer's disease dementia (AD). Behavioral and psychological symptoms of dementia (BPSD) are common and may also serve as early signals for dementia. However, comprehensive evaluation scales for BPSD, adapted to DS, are lacking. Therefore, we previously developed the BPSD-DS scale to identify behavioral changes between the last six months and pre-existing life-long characteristic behavior. OBJECTIVE: To optimize and further study the scale (discriminative ability and reliability) in a large representative DS study population. METHODS: Optimization was based on item irrelevance and clinical experiences obtained in the initial study. Using the shortened and refined BPSD-DS II, informant interviews were conducted to evaluate 524 DS individuals, grouped according to dementia status: no dementia (DS, N = 292), questionable dementia (DS + Q, N = 119), and clinically diagnosed dementia (DS + AD, N = 113). RESULTS: Comparing item change scores between groups revealed prominent changes in frequency and severity for anxious, sleep-related, irritable, restless/stereotypic, apathetic, depressive, and eating/drinking behavior. For most items, the proportion of individuals displaying an increased frequency was highest in DS + AD, intermediate in DS + Q, and lowest in DS. For various items within sections about anxious, sleep-related, irritable, apathetic, and depressive behaviors, the proportion of individuals showing an increased frequency was already substantial in DS + Q, suggesting that these changes may serve as early signals of AD in DS. Reliability data were promising. CONCLUSION: The optimized scale yields largely similar results as obtained with the initial version. Systematically evaluating BPSD in DS may increase understanding of changes among caregivers and (timely) adaptation of care/treatment
Publisher Correction: Truncated FGFR2 is a clinically actionable oncogene in multiple cancers.
This paper was originally published under a standard Springer Nature license
De <i>BPSD-DS</i> evaluatieschaal voor dementiegerelateerde gedragsveranderingen bij mensen met downsyndroom (<i>BPSD-DS II</i>):optimalisatie en verdere validatie
De <i>BPSD-DS</i> evaluatieschaal voor dementiegerelateerde gedragsveranderingen bij mensen met downsyndroom (<i>BPSD-DS II</i>):optimalisatie en verdere validatie
De <i>BPSD-DS</i> evaluatieschaal voor dementiegerelateerde gedragsveranderingen bij mensen met downsyndroom (<i>BPSD-DS II</i>):optimalisatie en verdere validatie
De <i>BPSD-DS</i> evaluatieschaal voor dementiegerelateerde gedragsveranderingen bij mensen met downsyndroom (<i>BPSD-DS II</i>):optimalisatie en verdere validatie
The prognostic role of tumor associated macrophages in squamous cell carcinoma of the head and neck: A systematic review and meta-analysis
Head and neck squamous cell carcinoma (HNSCC) is an immunogenic cancer type, and tumor associated macrophages (TAMs) are a major component of the tumor microenvironment (TME). In this systematic review and meta-analysis, studies assessing tumor infiltration with CD68+, iNOS+, HLA-DR+, CD11b+, CD163+, CD206+, and CD204+TAMs were included, and correlation to survival hazard was studied. A low number of CD68+TAMs correlated to better overall survival (OS) in multivariate analysis (HR 1.36 95 %CI (1.07–1.72) P = .01). CD68+TAMs did not correlate to disease free survival (DFS), disease specific survival (DSS), progression free survival (PFS), or recurrence free survival (RFS). A low number of CD163+TAMs correlated to better OS in uni- and multivariate analysis (resp. HR 2.65 95 %CI (1.57–4.46) P = .01 and HR 2.42 95 %CI (1.72–3.41) P < .001). A low number of CD163+TAMs also correlated to better DFS and PFS, whereas a low number of CD204+TAMs only correlated to PFS. While IHC analysis of pan macrophage marker CD68 and M2-like marker CD163 both show prognostic utility in OS, CD163 is a stronger prognosticator, as indicated by multivariate meta-analysis. CD163+TAMs also correlate to DFS and PFS; outcomes that are more relevant to patients, thus showing promising results for future clinical implementation
A Multicenter Retrospective Cohort Series of Muscle-invasive Bladder Cancer Patients Treated with Definitive Concurrent Chemoradiotherapy in Daily Practice
Background: Concurrent chemoradiotherapy (CRT) as a definitive treatment option for patients with nonmetastatic muscle-invasive bladder carcinoma (MIBC) is increasingly being applied in clinical practice. Objective: To assess the oncological and toxicity outcomes in a contemporary cohort of nonmetastatic MIBC patients treated with concurrent CRT in daily practice. Design, setting, and participants: Patients with nonmetastatic MIBC (cT2-4aN0M0) who had received CRT with curative intent between January 2010 and April 2020 in three centers were retrospectively identified. The CRT consisted of 66 Gy (or biologically equivalent) plus either mitomycin C and fluorouracil/capecitabine or cisplatinum. Outcome measurements and statistical analysis: The primary endpoint was the 2-yr locoregional disease-free survival (LDFS) estimate. Secondary endpoints were complete response, disease-specific survival (DSS), overall survival (OS), bladder intact event-free survival (BI-EFS), and severe adverse events (<90 d of starting CRT). Kaplan-Meier survival and Cox multivariable regression analyses were performed. Results and limitations: We included data of 240 MIBC patients with a median age of 74 yr and a median follow-up of 27 mo (interquartile range 11–44). Complete response on first cystoscopy after CRT was seen in 209 cases (90%). The 2-yr LDFS was 76% (95% confidence interval [CI] 70–82%); the 5-yr OS and DSS were 50% (95% CI 42–59%) and 70% (95% CI 62–79%), respectively. On multivariable analysis, cT2 versus cT3–4 tumor stage was significantly associated with better DSS (hazard ratio 1.02, 95% CI 1–1.05, p = 0.024). The 2-yr BI-EFS was 75% (95% CI 69–82%). Forty-three (17%) patients experienced a severe adverse event (grade ≥3). Limitations include retrospective design and heterogeneous administration of CRT. Conclusions: Concurrent CRT is a safe and effective treatment modality for nonmetastatic MIBC. Patient summary: Chemoradiotherapy for the treatment of muscle-invasive bladder carcinoma is increasingly being applied. In this study, we reviewed the outcomes of this bladder-sparing treatment using a series of patients treated in three hospitals in daily practice. We found that administration of chemoradiotherapy can be safe and effective
A Multicenter Retrospective Cohort Series of Muscle-invasive Bladder Cancer Patients Treated with Definitive Concurrent Chemoradiotherapy in Daily Practice
Background: Concurrent chemoradiotherapy (CRT) as a definitive treatment option for patients with nonmetastatic muscle-invasive bladder carcinoma (MIBC) is increasingly being applied in clinical practice. Objective: To assess the oncological and toxicity outcomes in a contemporary cohort of nonmetastatic MIBC patients treated with concurrent CRT in daily practice. Design, setting, and participants: Patients with nonmetastatic MIBC (cT2-4aN0M0) who had received CRT with curative intent between January 2010 and April 2020 in three centers were retrospectively identified. The CRT consisted of 66 Gy (or biologically equivalent) plus either mitomycin C and fluorouracil/capecitabine or cisplatinum. Outcome measurements and statistical analysis: The primary endpoint was the 2-yr locoregional disease-free survival (LDFS) estimate. Secondary endpoints were complete response, disease-specific survival (DSS), overall survival (OS), bladder intact event-free survival (BI-EFS), and severe adverse events (<90 d of starting CRT). Kaplan-Meier survival and Cox multivariable regression analyses were performed. Results and limitations: We included data of 240 MIBC patients with a median age of 74 yr and a median follow-up of 27 mo (interquartile range 11–44). Complete response on first cystoscopy after CRT was seen in 209 cases (90%). The 2-yr LDFS was 76% (95% confidence interval [CI] 70–82%); the 5-yr OS and DSS were 50% (95% CI 42–59%) and 70% (95% CI 62–79%), respectively. On multivariable analysis, cT2 versus cT3–4 tumor stage was significantly associated with better DSS (hazard ratio 1.02, 95% CI 1–1.05, p = 0.024). The 2-yr BI-EFS was 75% (95% CI 69–82%). Forty-three (17%) patients experienced a severe adverse event (grade ≥3). Limitations include retrospective design and heterogeneous administration of CRT. Conclusions: Concurrent CRT is a safe and effective treatment modality for nonmetastatic MIBC. Patient summary: Chemoradiotherapy for the treatment of muscle-invasive bladder carcinoma is increasingly being applied. In this study, we reviewed the outcomes of this bladder-sparing treatment using a series of patients treated in three hospitals in daily practice. We found that administration of chemoradiotherapy can be safe and effective