A Potential Multimodal Test for Clinical Assessment of Visual Attention in Neurological Disorders

Attention is an important aspect of human brain function and often affected in neurological disorders. Objective assessment of attention may assist in patient care, both for diagnostics and prognostication. We present a compact test using a combination of a choice reaction time task, eye-tracking and EEG for assessment of visual attention in the clinic. The system quantifies reaction time, parameters of eye movements (i.e. saccade metrics and fixations) and event related potentials (ERPs) in a single and fast (15 min) experimental design. We present pilot data from controls, patients with mild traumatic brain injury and epilepsy, to illustrate its potential use in assessing attention in neurological patients. Reaction times and eye metrics such as fixation duration, saccade duration and latency show significant differences (p < .05) between neurological patients and controls. Late ERP components (200–800 ms) can be detected in the central line channels for all subjects, but no significant group differences could be found in the peak latencies and mean amplitudes. Our system has potential to assess key features of visual attention in the clinic. Pilot data show significant differences in reaction times and eye metrics between controls and patients, illustrating its promising use for diagnostics and prognostication

Data from: DSM-5-TR prolonged grief disorder and DSM-5 posttraumatic stress disorder are related, yet distinct: confirmatory factor analyses in traumatically bereaved people

Prolonged grief disorder (PGD) is newly included in the text revision of the DSM-5 (DSM-5-TR). So far, it is unknown if DSM-5-TR PGD is distinguishable from bereavement-related posttraumatic stress disorder (PTSD). Prior research examining the distinctiveness of PTSD and pathological grief focused on non-traumatic loss samples, used outdated conceptualizations of grief disorders, and has provided mixed results. In a large sample of traumatically bereaved people, we first evaluated the factor structure of PTSD and PGD separately and then evaluated the factor structure when combining PTSD and PGD symptoms to examine the distinctiveness between the two syndromes. Self-reported data were used from 468 people bereaved due to the MH17 plane disaster (N = 200) or a traffic accident (N = 268). The 10 DSM-5-TR PGD symptoms were assessed with the Traumatic Grief Inventory-Self Report Plus (TGI-SR+). The 20-item Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) was used to tap PTSD symptoms. Confirmatory factor analyses were conducted. For PTSD, a seven factor, so-called ‘Hybrid’ model yielded the best fit. For PGD, a univariate factor model fits the data well. A combined model with PGD items loading on one factor and PTSD items on seven factors (associations between PGD and PTSD subscales r ≥ .50 and ≤.71), plus a higher-order factor (i.e. PTSD factors on a higher-order PTSD factor) (association between higher-order PTSD factor and PGD factor r = .82) exhibited a better fit than a model with all PGD and PTSD symptom loading on a single factor or two factors (i.e. one for PGD and one for PTSD). This is the first study examining the factor structure of DSM-5-TR PGD and DSM-5 PTSD in people confronted with a traumatic loss. The findings provide support that PGD constitutes a syndrome distinguishable from, yet related with, PTSD. This is the first factor analytic study on PGD and PTSD after traumatic loss.PTSD and PGD factors are related, but distinguishable.DSM-5-TR PGD is distinct from DSM-5 PTSD. This is the first factor analytic study on PGD and PTSD after traumatic loss. PTSD and PGD factors are related, but distinguishable. DSM-5-TR PGD is distinct from DSM-5 PTSD

Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data [Dataset]

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Stakeholders’ perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases

Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the ‘Dutch Biologic Monitor’. Generation of a multi-stakeholder perspective on the preferred setup, potential and added value of a PROM-based national drug safety monitoring system. Nineteen stakeholders were interviewed following a structured interview guide. Transcribed data were coded and analyzed to count frequencies and to generate recurring themes. Stakeholders (84.2%) support the establishment of a national drug safety monitoring system, but the feasibility depends on the implementation process. The need for integration and assessment of PROMs on ADRs in clinical practice and the preference to monitor small molecules and new drugs were emphasized. Preferably, all pharmacological options per indication should be monitored. Stakeholders recommend to establish a PROM-based national drug safety monitoring system focused on ADRs attributed to biologics, small molecules, and new drugs. Moreover, PROMs on ADRs ideally need to become integrated in clinical practice to provide health-care providers more insight in patients’ perspectives

Stakeholders’ perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases

Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the ‘Dutch Biologic Monitor’. Generation of a multi-stakeholder perspective on the preferred setup, potential and added value of a PROM-based national drug safety monitoring system. Nineteen stakeholders were interviewed following a structured interview guide. Transcribed data were coded and analyzed to count frequencies and to generate recurring themes. Stakeholders (84.2%) support the establishment of a national drug safety monitoring system, but the feasibility depends on the implementation process. The need for integration and assessment of PROMs on ADRs in clinical practice and the preference to monitor small molecules and new drugs were emphasized. Preferably, all pharmacological options per indication should be monitored. Stakeholders recommend to establish a PROM-based national drug safety monitoring system focused on ADRs attributed to biologics, small molecules, and new drugs. Moreover, PROMs on ADRs ideally need to become integrated in clinical practice to provide health-care providers more insight in patients’ perspectives

Study protocol of the GLOW study: maximising treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics—a prospective multicenter cohort study

Abstract Background Glioblastoma (GBM), the most common glial primary brain tumour, is without exception lethal. Every year approximately 600 patients are diagnosed with this heterogeneous disease in The Netherlands. Despite neurosurgery, chemo -and radiation therapy, these tumours inevitably recur. Currently, there is no gold standard at time of recurrence and treatment options are limited. Unfortunately, the results of dedicated trials with new drugs have been very disappointing. The goal of the project is to obtain the evidence for changing standard of care (SOC) procedures to include whole genome sequencing (WGS) and consequently adapt care guidelines for this specific patient group with very poor prognosis by offering optimal and timely benefit from novel therapies, even in the absence of traditional registration trials for this small volume cancer indication. Methods The GLOW study is a prospective diagnostic cohort study executed through collaboration of the Hartwig Medical Foundation (Hartwig, a non-profit organisation) and twelve Dutch centers that perform neurosurgery and/or treat GBM patients. A total of 200 patients with a first recurrence of a glioblastoma will be included. Dual primary endpoint is the percentage of patients who receive targeted therapy based on the WGS report and overall survival. Secondary endpoints include WGS report success rate and number of targeted treatments available based on WGS reports and number of patients starting a treatment in presence of an actionable variant. At recurrence, study participants will undergo SOC neurosurgical resection. Tumour material will then, together with a blood sample, be sent to Hartwig where it will be analysed by WGS. A diagnostic report with therapy guidance, including potential matching off-label drugs and available clinical trials will then be sent back to the treating physician for discussing of the results in molecular tumour boards and targeted treatment decision making. Discussion The GLOW study aims to provide the scientific evidence for changing the SOC diagnostics for patients with a recurrent glioblastoma by investigating complete genome diagnostics to maximize treatment options for this patient group. Trial registration: ClinicalTrials.gov Identifier: NCT05186064

Health-related quality of life of long-term advanced melanoma survivors treated with anti-CTLA-4 immune checkpoint inhibition compared to matched controls

Checkpoint inhibitors have changed overall survival for patients with advanced melanoma. However, there is a lack of data on health-related quality of life (HRQoL) of long-term advanced melanoma survivors, years after treatment. Therefore, we evaluated HRQoL in long-term advanced melanoma survivors and compared the study outcomes with matched controls without cancer. Ipilimumab-treated advanced melanoma survivors without evidence of disease and without subsequent systemic therapy for a minimum of two years following last administration of ipilimumab were eligible for this study. The European Organization for Research and Treatment of Cancer quality of life questionnaire Core 30 (EORTC QLQ-C30), the Multidimensional Fatigue Inventory (MFI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M) were administered. Controls were individually matched for age, gender, and educational status. Outcomes of survivors and controls were compared using generalized estimating equations, and differences were interpreted as clinically relevant according to published guidelines. A total of 89 survivors and 265 controls were analyzed in this study. After a median follow-up of 39 (range, 17–121) months, survivors scored significantly lower on physical (83.7 vs. 89.8, difference (diff) = −5.80, p=.005), role (83.5 vs. 90, diff = −5.97, p=.02), cognitive (83.7 vs. 91.9, diff = −8.05, p=.001), and social functioning (86.5 vs. 95.1, diff = −8.49, p= vs. 15.5, diff = 7.48, p=.004), dyspnea (13.3 vs. 6.7, diff = 6.47 p=.02), diarrhea (7.9 vs. 4.0, diff = 3.78, p=.04), and financial impact (10.5 vs. 2.5, diff = 8.07, p=.001) than matched controls. Group differences were indicated as clinically relevant. Compared to matched controls, long-term advanced melanoma survivors had overall worse functioning scores, more physical symptoms, and financial difficulties. These data may contribute to the development of appropriate survivorship care