Validation of the German version of the Family Reported Outcome Measure (FROM-16) to assess the impact of disease on the partner or family member

Background The Family Reported Outcome Measure (FROM-16) assesses the impact of a patient’s chronic illness on the quality of life (QoL) of the patient’s partner or family members. The aim of the study was to translate, explore the structure of and validate the FROM-16. Methods The questionnaire was translated from English into German (forward, backward, four independent translators). Six interviews with family members were conducted to confirm the questionnaire for linguistic, conceptual, semantic and experiential equivalence and its practicability. The final German translation was tested for internal consistency, reproducibility and test validity. Criterion validity was tested by correlating the scores of the FROM-16 and the Global Health Scale (GHS). Principal component analysis, factor analysis, and confirmatory factor analysis was used to assess the questionnaire’s structure and its domains. Reliability and reproducibility were tested computing the intraclass correlation coefficient (ICC) using one sample t-test for testing the hypothesis that the difference between the scores was not different from zero. Results Overall, 83 family members (61% female, median age: 61 years) completed the questionnaire at two different times (mean interval: 22 days). Internal consistency was good for the FROM-16 scores (Cronbach’s α for total score = 0.86). In those with stable GHS, the ICC for the total score was 0.87 and the difference was not different from zero (p = 0.262) indicating reproducible results. A bi-factor model with a general factor including all items, and two sub-factors comprising the items from the original 2-factor construct had the best fit. Conclusions The German FROM-16 has good reliability, test validity and practicability. It can be considered as an appropriate and generic tool to measure QoL of a patient’s partner or family member. Due to the presence of several cross-loadings we do not recommend the reporting of the scores of the two domains proposed for the original version of FROM-16 when using the German version. Thus, in reporting the results emphasis should be put on the total score

Automated Processing of Pipelines Managing Now- and Forecasting of Infectious Diseases

When faced with the challenge of now- and forecasting infectious diseases, multiple data sources and state-of-the-art models have to be considered. Automatic aggregation, processing, and publishing to relevant data sinks is paramount to achieving consistent, reproducible, and timely results given daily-reported data. To facilitate scientific collaboration and reproducibility of workflows, open and extensible architectures for compute pipelines are required. In this research, we devise an architecture realizing the seamless management and processing of reproducible pipelines. Our case-study is a daily pipeline for nowcasting the state of SARS-CoV-2 in Germany based on public data and state-of-the-art models implemented in the simulation software MEmilio. The results of our pipeline are pushed to ESID (Epidemiological Scenarios for Infectious Diseases), a user interface to epidemiological simulations. To realize the given pipeline, a workflow management system is required to ensure pipeline processing and secure access to multiple heterogeneous data storages. For this purpose, we based our work on an open-source workflow management system - Apache Airflow, which provides the orchestration, coordination and management of complex connected tasks. S3 is utilized as an intermediate data storage service for sharing data between workflow steps and persisting experiment output. We provide a comprehensive view on our work on automated, end-to-end and reproducible pipelines, with detailed commentary on use case, and its realization

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

The regression discontinuity design: Methods and implementation with a worked example in health services research

Background: The randomized controlled trial (RCT) is the gold standard in evidence-based medicine. However, this design may not be appropriate in every setting, so other methods or designs such as the regression discontinuity design (RDD) are required. Method: The aim of this article is to introduce the RDD, summarise methodology in the context of health services research and present a worked example using the statistic software SPSS (Examples for R and Stata in the Appendix A). The mathematical notations of sharp and fuzzy RDD as well as their distinction are presented. Furthermore, examples from the literature and recent studies are highlighted, and both advantages and disadvantages of the design are discussed. Application: The RDD consists of four essential steps: 1. Determine feasibility; 2. Note possible treatment manipulation, 3. Check for the treatment effect, and 4. Fit the regression models to measure the treatment effect. Conclusion: The RDD comes as an alternative for studies in health service research where an RCT cannot be conducted, but a threshold-based comparison can be made

Erfassung der Mundgesundheit von ambulant betreuten Senioren durch Hausärzte

Background!#!Despite a high prevalence in the general practitioner (GP) and geriatric field, limitations of oral health of seniors under outpatient care in Germany are not routinely recorded. Since seniors with a high age visit GPs more often than dentists, the question arises whether an interdisciplinary screening instrument can be used to identify reduced oral health in routine practice.!##!Objective!#!The aim of the work was to develop a screening tool for reduced oral health for GPs and to validate this by dental examinations.!##!Material and methods!#!The geriatric outpatient oral health screening (GAMS) was developed as a subjective screening instrument to depict dental aspects relevant for geriatric patients, such as chewing problems, pain, periodontitis, bad breath or dry mouth in dichotomous questions. The urgency of a visit to the dentist is also assessed by the family doctor. A total of 75 patients were included and the GAMS and a dental examination were performed for validation.!##!Results!#!The subjective assessment of patients and dental findings showed reduced oral health especially with recognized risk factors for the development of systemic comorbidities, such as dysphagia and malnutrition, whereas oral health problems were underestimated by patients. Bites, chewing problems and dry mouth showed sufficient correspondence between dental findings and subjective assessment.!##!Conclusion!#!The GAMS could help facilitate the consideration of oral health problems in geriatric patients in a GP setting and promote cooperation with dentists in the sense of European recommendations for action

Using the modified Schirmer test for dry mouth assessment: A cross-sectional study

This study aimed to establish whether the modified Schirmer test could serve as a diagnostic tool for dry mouth, that is, whether it could reliably measure salivary film at selected locations within the oral cavity, and to identify levels of sensitivity/specificity and determine reference values. Therefore, a cross-sectional study (N = 120, mean age 63.5 [SD 13.9] years) was performed. The test was used at five locations (hard palate; buccal mucosa in molar region at 4 mm above occlusal plane; anterior tongue; lower lip; mouth floor), and results were recorded after 1, 2 and 3 min. A statistically significant discriminatory ability of the Schirmer test for the unstimulated salivary flow rates could be shown for the palate (at 3 min), buccal mucosa (at 1 min), mouth floor (at 1 min), and tongue (at 2 and 3 min) (areas under the curve 0.64-0.68), with individual sensitivity/specificity values depending on test location/time points. Thus, the modified Schirmer test has potential to become a simple and reproducible instrument for the detection of dry mouth based on low unstimulated salivary flow rates in dentistry and especially outreach care. Care must be taken concerning intraoral test location and measurement time

White blood cell counts, CRP, GGT and LDH in the elderly German population

Background: Hematological abnormalities are frequently found in geriatric patients. However, little data is available on reference values for total blood cell counts in older patients. This study is focused on the analysis of reference values for white blood cell counts in aged persons >= 60 years. Methods: This was a cross-sectional study of outpatient laboratory data of 2015 from a German country-wide working laboratory company; inclusion criteria: age >= 60 years, parameters evaluated by the laboratory company between 1.1.2015 and 31.12.2015; exclusion criteria: glomerular filtration rate (GFR) = 60 years. Results: Data of 30,611 persons aged >= 60 years were evaluated by age groups. Results for leukocytes, basophils, eosinophils, neutrophils and lymphocytes remained within the reference ranges recommended by the German Society of Hematology and Oncology (DGHO) and the German Association of Specialists in Internal Medicine (BDI); the lower reference limit for normal platelet values in males was below the DGHO reference value with 136,000/mu L (confidence interval [CI] 129,000; 142,000); similarly, our results for normal monocyte values were above the DGHO reference values with 6.0% (5.7;6.2) to 14.3% (13.9;14.8) in males and 5.4% (5.2;5.6) to 12.9% (12.6;13.4) in females; CRP, GGT and LDH values were above the BDI reference values, comparable with the previous data of a senior patient cohort analysis. Conclusions: Adaptation of reference values for selected laboratory parameters in older German patients should be well considered

Care need and dry mouth as risk indicators for impaired taste and smell

To identify whether reduced saliva secretion or xerostomia symptoms are risk indicators for impaired taste and smell, depending on age and care needs. This cross-sectional study evaluated taste and smell in patients categorized into different age groups ( years) and different care need, with and without dry mouth. Of the 185 patients included, 119 were classified as dry mouth and 66 as without dry mouth. Overall, 103 (55.7%) were female and 37 (20%) needed care. There was no difference between dry mouth and without dry mouth regarding identification of odors or tastes, but a difference in the number of correctly identified odors and tastes in favor of without care need patients (p < 0.05). The ability to identify smells and tastes was negatively influenced by age, number of medications, and number of comorbidities, but subjective dry mouth had no impact. According to our results, subjective dry mouth is not a risk factor for an impaired ability to recognize smells and tastes. However, care need representing age, the number of medications taken, and the number of chronic comorbidities is a risk indicator

Oral health assessment of seniors under outpatient care by family doctors Development and validation of the geriatric outpatient oral health screening

Background Despite a high prevalence in the general practitioner (GP) and geriatric field, limitations of oral health of seniors under outpatient care in Germany are not routinely recorded. Since seniors with a high age visit GPs more often than dentists, the question arises whether an interdisciplinary screening instrument can be used to identify reduced oral health in routine practice. Objective The aim of the work was to develop a screening tool for reduced oral health for GPs and to validate this by dental examinations. Material and methods The geriatric outpatient oral health screening (GAMS) was developed as a subjective screening instrument to depict dental aspects relevant for geriatric patients, such as chewing problems, pain, periodontitis, bad breath or dry mouth in dichotomous questions. The urgency of a visit to the dentist is also assessed by the family doctor. A total of 75 patients were included and the GAMS and a dental examination were performed for validation. Results The subjective assessment of patients and dental findings showed reduced oral health especially with recognized risk factors for the development of systemic comorbidities, such as dysphagia and malnutrition, whereas oral health problems were underestimated by patients. Bites, chewing problems and dry mouth showed sufficient correspondence between dental findings and subjective assessment. Conclusion The GAMS could help facilitate the consideration of oral health problems in geriatric patients in a GP setting and promote cooperation with dentists in the sense of European recommendations for action

Anatomical In Vitro Investigations of the Pediatric Larynx: A Call for Manufacturer Redesign of Tracheal Tube Cuff Location and Perhaps a Call to Reconsider the Use of Uncuffed Tracheal Tubes

BACKGROUND: Some in vivo studies question the traditional funnel-shaped infant larynx; further anatomic examinations were warranted. Examination of fixative free fresh autopsy laryngeal and upper tracheal specimens and multiple measurements was needed to determine consistency between current tracheal tube designs and anatomic observations. METHODS: Larynges from 19 males and 11 females (Caucasian term newborn to 126 months) were examined by the same forensic pathologist. Measurements included anterior/posterior (A/P) and transverse (T) diameters of the cricoid outlet (CO), interarytenoid diameter (IAD), cricothyroid membrane (CTM), distance from the vocal cords (VC) to CO (VC-CO), and calibration of the larynx lumen with uncuffed tracheal tubes as measuring rods. Assessment of safe tracheal tube placement was assessed using manufacturer recommended cuffed Microcuff (Kimberly-Clark, Koblenz, Germany) tubes. RESULTS: In 77% (95% confidence interval [CI], 58-90) of specimens, the proximal end of the cuff was within the CO and in 23% even with or close to the CO. The VC-CO varied from 9.1 to 13.17 mm in infants, 11.55 to 15.17 mm in toddlers, and 13.19 to 18.34 mm in children. The A-P/T ratio of the CO was nearly 0.99 in most larynges; the IAD was greater than CO in all specimens. The CTM could be minimally distended in all specimens. CONCLUSIONS: First, despite being marketed as a safer tracheal tube design, the proximal end of the Microcuff cuff rested within or close to the cricoid cartilage theoretically increasing potential cuff-induced injury when using the VC markings for positioning. Our data suggest that the optimal cuff free distance (VC-CO) would be similar to 13.5 mm for a Microcuff internal diameter (ID) size 3.0, similar to 15 mm for size 3.5, and similar to 16 to 19 mm for greater sizes. Second, the CO was virtually circular in all specimens, suggesting that appropriately sized uncuffed tubes should provide an adequate seal in most neonates and toddlers, thus avoiding the potential for cuff-related necrosis injury. Third, the IAD was always greater than CO confirming that the narrowest point of the infant larynx is the nondistensible cricoid cartilage and not the easily distended glottis. Fourth, appropriately sized Microcuff tubes with the cuff deflated completely filled the lumen of the CO and proximal trachea in all specimens. Our data suggest the need for all manufacturers to further evaluate tracheal tube cuff locations and lengths in relation to the VC safe insertion markings, particularly for neonates and toddlers. Fifth, the CTM is minimally distensible, thus having important implications for emergency surgical airway access with most currently available emergency airway devices