Search

Abstract Background Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable. Methods The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Seventy patients (30 control group, 30 intervention group, 10 drop-out rate of 15%) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both detailed subjective assessment of swallowing function and quality of life by means of various questionnaires and objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: detailed counseling with video demonstration and exercises to strengthen and improve the range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed at 6 weeks, 3 and 6 months, and 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary study endpoints are swallowing function and emotional distress at 6 weeks of control visit. Discussion Prehabilitation measures have already proven successful in other patient groups, e.g., transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually, only subgroups, e.g., patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life. Trial registration German Clinical Trials Register DRKS00029676 . International Clinical Trials Registry Platform DRKS00029676 . Registered on 19 July 2022.

BackgroundPrehabilitation is becoming increasingly important in oncology because of the significant survival benefits that the reduction of malnutrition provide. Specifically, tumor- and therapy-related dysphagia leads to malnutrition in more than half of head and neck tumor patients. Studies describe the positive effects of an early onset of swallow-specific prehabilitation on the protection of the swallowing function. This paper intents to evaluate the existing evidence on the efficacy of preventive forms of swallowing therapy.MethodsA systematic literature search was performed in February 2022 in the Cochrane Library, MEDLINE via PubMed, and ClinicalTrials.gov databases for randomized controlled trials investigating preventive swallowing therapy in head and neck tumor patients. This Procedure complies with the PRISMA statement. The RCTs were evaluated by using the PEDro Scale and the Cochrane Risk of Bias tool RoB2.ResultsFive randomized-controlled trials with 423 participants were identified. Four Studies showed moderate to high quality in the PEDro analysis, one showed less. The risk of bias was high in all studies because there was no possibility for blinding and there were high dropout rates. Heterogeneity in interventions, measurement instruments, measurement time points, and outcomes limits a general statement about which swallowing exercises are suitable for the prevention of dysphagia in head and neck tumor patients. Evidence is provided for short-term effects (≤24 months) on functional aspects of swallowing and quality of life. Overall, a decreasing adherence over time was observed in the intervention groups.DiscussionInitial studies describe swallowing-specific prehabilitation programs in head and neck tumor patients as effective, at least in the short term, whereas long-term effects need to be further investigated. At the current time the evidence base for clear recommendations does not appear to be sufficiently high and studies share a high risk of bias. Further well-designed research, especially considering the conditions in the national health care system, is needed.OtherThere was no funding and no registration.

Abstract Background Congenital cytomegalovirus (cCMV) infection can cause severe neurological damage, growth retardation, hearing loss, and microcephaly in infants. We aimed at assessing healthcare costs of infants with recorded cCMV diagnosis in an administrative claims database in the first 2 years of life. Methods We conducted a retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database. Incremental healthcare costs during the first and second year of life were assessed by matching (1:60) infants with cCMV diagnoses ≤ 90 days after birth (cCMV90 cohort) to infants without cCMV diagnosis (“representative” controls) and infants with cCMV diagnoses ≤ 21 days after birth plus specific symptoms (cCMV21-S) to infants without cCMV and any ICD-10-GM records (besides Z00-Z99) until 4th preventive health check-up (“healthy” controls). Due to missing data, mean imputation was applied for aids and remedies costs. Results We identified 54 and 24 infants born 2014–2018 for the cCMV90 and cCMV21-S cohorts, respectively. During the first year, mean (median) healthcare costs were significantly higher in cCMV90 cases vs. “representative” controls (€22,737 (€9759) vs. €3091 (€863), p

BackgroundCongenital cytomegalovirus (cCMV) infection can have a broad range of manifestations. This study aimed to assess cCMV-associated sequelae and healthcare resource utilization (HCRU) in infants during the first year of life in Germany.MethodsA retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database was conducted. cCMV-associated sequelae and HCRU during the first year of life were assessed by matching (1:60) infants with at least one inpatient/outpatient cCMV diagnosis (ICD-10-GM: P35.1) ≤90 days after birth (cCMV90 cohort) and infants with at least one inpatient cCMV diagnosis plus specific sequelae ≤21 days after birth (cCMV21-S) to infants without cCMV or CMV (ICD-10-GM: B25) diagnosis (control group), respectively. Outcomes were analyzed during the first 365 days of life.ResultsBetween 2014-2018, we identified 54 newborns for cCMV90 and 24 newborns for cCMV21-S cohort. Compared to the 3,240 and 1,440 controls, respectively, more cCMV90 infants (83.3% vs. 41.9%, pConclusionscCMV-infection shows a considerable disease and healthcare burden during the first year of life. More than 80% of the identified newborns with cCMV suffered from at least one associated sequela during the first year of life, including long-term sequelae such as SNHL (40%) and visual impairment (13%). Additional steps for prevention of cCMV infection and associated sequelae as well as a comprehensive monitoring of disease burden are needed.

Evidence-based guidelines for the prevention, diagnosis and treatment of congenital cytomegalovirus (cCMV) were recently released by two independent expert groups. Of particular emphasis was the relationship between cCMV and sensorineural hearing loss (SNHL), a major component of the virus’ overall disease burden. In this study, a literature review was performed to estimate the proportion of cCMV-related SNHL cases, which might be identified through selective cCMV testing following failed newborn hearing screening. Furthermore, it was of interest to estimate the potential benefit of emerging antiviral therapies. Currently, at most 10% of cCMV-related SNHL is likely to be identified clinically. Through use of a selective cCMV testing protocol, however, a significant improvement in the identification rate can be achieved. Recent expert group statements strongly recommend antiviral therapy in cases of moderate-to-severe disease, especially in the presence of central nervous system involvement. Though differences exist between recommendations in instances of isolated SNHL or SNHL in combination with only mild symptoms, the majority of experts in both groups offered at least a weak recommendation for antiviral treatment. Available results suggest antiviral treatment could therefore benefit a meaningful proportion of newborns referred for cCMV testing following failed newborn hearing screening.

Numerical simulations of rockfall trajectories are a standard procedure for evaluating rockfall hazards. For these simulations, corresponding software codes must be calibrated and evaluated based on field data. This study addresses methods of repeatable rockfall tests, and investigates whether it is possible to produce traceable and statistically analysable data. A testing series is described extensively covering how to conduct rockfall experiments and how certain elements of rockfall trajectories can be measured. The tests use acceleration and rotation sensors inside test blocks, a system to determine block positions over time, surveying measurements, and video recordings. All systems are evaluated regarding their usability in the field and for analyses. The highly detailed description of testing methods is the basis for sound understanding and reproducibility of the tests. This article serves as a reference for future publications and other rockfall field tests, both as a guide and as a basis for comparisons. First analyses deliver information on runout with a shadow angle ranging between 21 and 45 degrees for a slope consisting of homogeneous soft soil. A digital elevation model of the test site as well as point clouds of the used test blocks are part of this publication.

Rockfall protection barriers are connected to the ground using steel cables fixed with anchors and foundations for the steel posts. It is common practice to measure the forces in the cables, while to date measurements of forces in the foundations have been inadequately resolved. An overview is presented of existing methods to measure the loads on the post foundations of rockfall protection barriers. Addressing some of the inadequacies of existing approaches, a novel sensor unit is presented that is able to capture the forces acting on post foundations in all six degrees of freedom. The sensor unit consists of four triaxial force sensors placed between two steel plates. To correctly convert the measurements into the directional forces acting on the foundation a special in-situ calibration procedure is proposed that delivers a corresponding conversion matrix.