Purpose: Outpatient parenteral antimicrobial therapy (OPAT) offers several key advantages, including enhanced patient quality of life, reduced healthcare costs, and a potential reduction of nosocomial infections. It is acknowledged for its safety and effectiveness. This study provides the first systematic clinical data for Germany, where OPAT has not yet been widely adopted. The aim is to establish a foundational reference point for further research and integration of OPAT into the German healthcare system. Methods: This prospective observational study descriptively analyses data obtained from a cohort of patients receiving OPAT. Both in- and outpatients from all medical specialties could be recruited. Patients administered the anti-infective medications themselves at home using elastomeric pumps. Results: 77 patients received OPAT, with a median duration of 15 days and saving 1782 inpatient days. The most frequently treated entities were orthopaedic infections (n = 20, 26%), S. aureus bloodstream infection (n = 16, 21%) and infectious endocarditis (n = 11, 14%). The most frequently applied drugs were flucloxacillin (n = 18, 23%), penicillin G (n = 13, 17%) and ceftriaxone (n = 10; 13%). Only 5% of patients (n = 4) reported to have missed more than one outpatient dose (max. 3 per patient). Only one catheter-related adverse event required medical intervention, and there were no catheter-related infections. Conclusion: The study demonstrates that OPAT can be safely conducted in Germany. In preparation for its broader implementation, crucial next steps include creating medical guidelines, fostering interdisciplinary and inter-sectoral communication, as well as creating financial and structural regulations that facilitate and encourage the adoption of OPAT. Trial registration number: NCT04002453.

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. 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. 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. 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.

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.

Purpose: The risk of developing active tuberculosis (TB) is considerably increased in people living with HIV/AIDS (PLWH). However, incidence of HIV/TB coinfection is difficult to assess as surveillance data are lacking in many countries. Here, we aimed to perform a quantitative analysis of HIV/TB coinfections within the Cologne/Bonn HIV cohort and to determine risk factors for active TB. Methods: We systematically evaluated data of patients with HIV/TB coinfection between 2006 and 2017. In this retrospective analysis, we compared HIV/TB-coinfected patients with a cohort of HIV-positive patients. The incidence density rate (IDR) was calculated for active TB cases at different time points. Results: During 2006–2017, 60 out of 4673 PLWH were diagnosed with active TB. Overall IDR was 0.181 cases/100 patient-years and ranged from 0.266 in 2006–2009 to 0.133 in 2014–2017. Patients originating from Sub-Saharan Africa had a significantly (p < 0.001) higher IDR (0.694/100 patient-years of observation, 95% CI [0.435–1.050]) in comparison to patients of German origin (0.053/100 patient-years of observation, 95% CI [0.028–0.091]). In terms of TB-free survival, individuals originating from countries with a TB incidence higher than 10/100,000 exhibited a markedly reduced TB-free survival compared to those originating from regions with lower incidence (p < 0.001). In 22 patients, TB and HIV infection were diagnosed simultaneously. Conclusion: Overall, we observed a decline in the incidence density rate (IDR) of HIV/TB coinfections between 2006 and 2017. Patients originating from regions with high incidence bear a higher risk of falling ill with active TB. For PLWH born in Germany, the observed risk of active TB appears to be lower compared to other groups within the cohort. These findings should be considered when developing TB containment and screening strategies for PLWH in low-incidence countries.

Objective: To assess the mid‐term efficacy and safety of anterior urethroplasty using an autologous tissue‐engineered oral mucosa graft (MukoCell^®).Methods: The data of 77 patients with anterior urethral strictures undergoing treatment with MukoCell^® at a tertiary center from June 2016 to May 2019 were analyzed. Patients’ characteristics, pre‐ and postoperative diagnostics, perioperative complications, and follow‐up data were obtained. The overall stricture‐free survival, outcomes of the different surgical techniques, stricture localizations, stricture length, early complications of the procedure and risk factors of recurrence were assessed.Results: The median follow‐up period was 38 months (interquartile range 31–46). The overall recurrence‐free rate of anterior urethroplasty using MukoCell^® was 68.8%, 24 patients (31.2%) developed a recurrence of the stricture. The stricture recurrences were observed at a median of 7 months (interquartile range 3–13) only in patients with at least one previous surgery or repeated dilatations in their medical history. No oral‐urethral adverse events related to the use of MukoCell^® were observed, except for a urethrocutaneous fistula (1.3%) requiring reoperation.Conclusions: Anterior one‐stage urethroplasty using MukoCell^® showed in our hands a mid‐term success rate of up to 68.8% without significant adverse events after a median follow‐up period of 38 months. This procedure might be an alternative option for long‐segment urethral reconstruction.

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. Trial registration: Retrospectively registered: DRKS00021070.