Exploring patients' perspectives: a mixed methods study on Outpatient Parenteral Antimicrobial Therapy (OPAT) experiences.

BACKGROUND: Outpatient Parenteral Antimicrobial Therapy (OPAT), an alternative to inpatient intravenous antibiotic therapy, has shown benefits in international studies such as increased patient satisfaction. Because OPAT has been used only sporadically in Germany so far, no structured results on patients' experiences and concerns regarding OPAT have yet been available. This study therefore aims to explore the experiences of OPAT patients in a pilot region in Germany. METHODS: This is an observational study in a German pilot region, including a survey of 58 patients on their experiences with OPAT, and in-depth interviews with 12 patients (explanatory-sequential mixed-methods design). RESULTS: Patients reported that they were satisfied with OPAT. That a hospital discharge was possible and anti-infective therapy could be continued in the home environment was rated as being particularly positive. In the beginning, many patients in the interviews were unsure about being able to administer the antibiotic therapy at home on their own. However, healthcare providers (doctors and pharmacy service provider staff) were able to allay these concerns. Patients appreciated regular contact with care providers. There were suggestions for improvement, particularly concerning the organization of the weekly check-up appointments and the provision of information about OPAT. CONCLUSIONS: Patients were generally satisfied with OPAT. However, the treatment structures in Germany still need to be expanded to ensure comprehensive and high-quality OPAT care. TRIAL REGISTRATION: NCT04002453, https://www. CLINICALTRIALS: gov/ , (registration date: 2019-06-21).

Does the mode of care delivery affect therapeutic alliance, patient care satisfaction or patient reported outcomes? Psycho-oncological care evaluation data collected during the COVID-19 pandemic.

PURPOSE: Since the COVID-19 pandemic, psycho-oncological care has increasingly been provided virtually and/or telephonically. We examined whether patients' therapeutic alliance (TA) - an essential processual outcome - differs due to altered modes of care delivery (MOCD) and assessed, if MOCD impacts patients' care satisfaction and patient reported outcomes. METHODS: Survey and documentation data from newly diagnosed cancer patients that were cared for in the new form of care 'isPO' in Germany, were analyzed. Patients were surveyed after completing the one-year psycho-oncological care program. MOCD was operationalized by the ratio of patients' face-to-face, telephonic or video-based consultations to all their consultations. Regression analyzes were conducted to determine a possible relationship between MOCD and TA, between MOCD and patients' care satisfaction ('subjective effectiveness' and 'satisfaction and needs-orientation') and patient reported outcomes (anxiety and depression, sense of coherence, global health status). FINDINGS: MOCD does not significantly influence TA. Regression models on the possible effect on subjective effectiveness and satisfaction and needs-orientation do not show statistical significance with only MOCD as the predictor. MOCD does not predict any of the patient reported outcomes. CONCLUSIONS: During the pandemic, neither TA, care satisfaction nor patient reported outcomes were affected by the MOCD in the new form of care 'isPO'. Therefore, the MOCD didn't negatively affect quality of care, which indicates that telephone or video consultations seem to be useful alternatives for psycho-oncological care in Germany.

Outpatient parenteral antimicrobial therapy (OPAT) in Germany: insights and clinical outcomes from the K-APAT cohort study.

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.

Incidence and risk factors for HIV-tuberculosis coinfection in the Cologne-Bonn region: a retrospective cohort study.

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.

The impact of COVID-19 on the interpretation of psycho-oncological support trial results: a quasi-experimental approach using the data from the new form of care "Integrated cross-sectoral psycho-oncology (nFC-isPO)".

OBJECTIVE: In addition to the common difficulties of ongoing trials, the COVID-19 pandemic posed several challenges to scientists worldwide and created an additional burden for vulnerable patient groups. In the nFC-isPO of individualised treatment for anxiety and depression in newly diagnosed patients with cancer caregivers (e.g. psycho-oncologists) reported elevated HADS scores in newly enrolled patients after the outbreak of the COVID-19 pandemic. Accordingly, the question arises whether the pandemic affected HADS scores. Therefore, stratified analyses by the time of enrolment (T1) were performed for patients with 12 months of care (T3). METHODS: Patients with 12 months of care (N = 1,140) were analysed. A comparison within the regression discontinuity design according to the time points at which patients completed the baseline (T1) HADS questionnaire was conducted to examine differences between patients recruited before Q2/2020 (pre-pandemic) and after the coronavirus outbreak. Furthermore, mean HADS scores at T1 and T3 for all quarters during the study were compared. RESULTS: Mean T1 and T3 HADS scores of patients with cancer during the pandemic are only slightly higher than those of the pre-pandemic group. No significant treatment effect was observed in either the pre-pandemic (p = 0.5495, Late = 1.7711) or the post-pandemic group (p = 0.9098, LATE=-0.2933). In contrast, the average local treatment effect in the post-pandemic group suggests a minimal decrease in HADS score in the predefined range and thus a positive treatment effect for isPO. Comparison of mean HADS scores at T1 and T3 did not show a large increase by pandemic-related timepoints, however, a decrease of approximately 2-3 points over each quarter at 12 months compared to baseline is observed. CONCLUSION: The existing nFC-isPO care is resilient to crisis and may counteract external influences such as the Corona pandemic. Accordingly, the pandemic had little influence on the fears of patients with cancer in the nFC-isPO. This emphasises that psycho-oncology is vital for the reduction of stress, anxiety and depression in patients with cancer. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry on 30 October 2018 under the ID "DRKS00015326".

How does stress affect maternal and paternal perceptions of relationship strain after a preterm birth? Results of a retrospective survey study.

AIM: Strain on couple relationships is associated with a lower well-being. As premature birth is known to pose stress to parents, this study explores whether interparental relationship strain comes to pass within mothers and fathers during their infant's stay in a neonatal intensive care unit. METHODS: A retrospective cross-sectional survey was conducted with parents who experienced a preterm birth (September to December 2020). Linear regression was used to analyse associations between stress and relationship strain. RESULTS: The study included 437 mothers and 301 fathers. Fathers experienced lower relationship strain (M = 2.49, SD = 1.00) than mothers (M = 3.37, SD = 1.04). Overall, a significant association between relationship strain and stress due to the infant's behaviour and appearance was found for mothers (ß = 0.16, p = 0.02) and fathers, with a significantly higher association for fathers (ß = 0.27, p ≤ 0.002). With regard to parental role alterations, only mothers showed a significant association (ß = 0.21, p ≤ 0.001). CONCLUSION: Although mothers showed higher levels of stress and relationship strain, stress may also have an impact on fathers. Therefore, research should focus on stress prevention measures to meet both maternal and paternal needs.

Outpatient parenteral antimicrobial therapy in Germany: a prospective cohort study protocol.

INTRODUCTION: Outpatient parenteral antimicrobial therapy (OPAT) means intravenous administration of antibiotics outside the hospital. The antibiotics are administered at the patient's home. The advantages are the shortening of the inpatient stay, which means that patients can remain in their familiar environment, the reduction of nosocomial infections as well as the reduction of hospital and therapy costs. Nevertheless, OPAT is rarely performed in Germany, despite its international application. Therefore, systematic data on OPAT are not available in Germany. The project objective is to investigate the medical care using OPAT under medical, epidemiological and economic aspects within the framework of the Cologne Network of Infectious Diseases. METHODS AND ANALYSIS: Observational study with mixed-methods approach, qualitative analysis to identify physician-side factors to assess the attitude of general practitioners in Cologne with regard to possible implementation barriers of an OPAT. Longitudinal analysis of an OPAT patient cohort with respect to clinical and patient-relevant outcomes using descriptive and conclusive statistics. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of the University of Cologne, Germany (19-1284-1). Written informed consent was obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. TRIAL REGISTRATION NUMBER: NCT04002453.

Outcome Quality After Colorectal Cancer Resection in Certified Colorectal Cancer Centers­Patient-Reported and Short-Term Clinical Outcomes.

BACKGROUND: In this observational study, patient-reported outcomes and short-term clinical outcome parameters in patients with colorectal cancer were studied 12 months after the start of treatment. Outcomes were also compared across German Certified Colorectal Cancer Centres. METHODS: Data were collected from 4239 patients with colorectal cancer who had undergone elective tumor resection in one of 102 colorectal cancer centers and had responded to a quality-of-life questionnaire before treatment (EORTC QLQ-C30 and -CR29). 3142 (74.1%) of these patients completed a post-treatment questionnaire 12 months later. Correlation analyses were calculated and case-mix adjusted comparisons across centers were made for selected patient-reported outcomes, anastomotic insufficiency, and 30-day-mortality. RESULTS: At 12 months, mild improvements were seen in mean quality-of-life scores (66 vs. 62 points), constipation (16 vs. 19), and abdominal pain (15 vs. 17). Worsening was seen in physical function (75 vs. 82) and pain (22 vs. 19). Better patient-reported outcomes at 12 months were associated with better scores before treatment. Better results in at least three of the five scores were associated with male sex, higher educational level, higher age, and private health insurance. Major worsening of fecal incontinence was seen among patients with rectal cancer without a stoma. The largest differences across centers were found with respect to physical function. Anastomotic insufficiency was found in 4.3% of colon cancer patients and 8.2% of rectal cancer patients. 1.9% of patients died within 30 days after their resection. CONCLUSION: Clinicians can use these findings to identify patients at higher risk for poorer patient-reported outcomes. The differences among cancer centers that were found imply that measures for quality improvement would be desirable.

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.

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.

Clinical covariates that improve surgical risk prediction and guide targeted prehabilitation: an exploratory, retrospective cohort study of major colorectal cancer surgery patients evaluated with preoperative cardiopulmonary exercise testing.

BACKGROUND: Preoperative risk stratification is used to derive an optimal treatment plan for patients requiring cancer surgery. Patients with reversible risk factors are candidates for prehabilitation programmes. This pilot study explores the impact of preoperative covariates of comorbid disease (Charlson Co-morbidity Index), preoperative serum biomarkers, and traditional cardiopulmonary exercise testing (CPET)-derived parameters of functional capacity on postoperative outcomes after major colorectal cancer surgery. METHODS: Consecutive patients who underwent CPET prior to colorectal cancer surgery over a 2-year period were identified and a minimum of 2-year postoperative follow-up was performed. Postoperative assessment included: Clavien-Dindo complication score, Comprehensive Complication Index, Days at Home within 90 days (DAH-90) after surgery, and overall survival. RESULTS: The Charlson Co-morbidity Index did not discriminate postoperative complications, or overall survival. In contrast, low preoperative haemoglobin, low albumin, or high neutrophil count were associated with postoperative complications and reduced overall survival. CPET-derived parameters predictive of postoperative complications, DAH-90, and reduced overall survival included measures of VCO2 kinetics at anaerobic threshold (AT), peakVO2 (corrected to body surface area), and VO2 kinetics during the post-exercise recovery phase. Inflammatory parameters and CO2 kinetics added significant predictive value to peakVO2 within bi-variable models for postoperative complications and overall survival (P < 0.0001). CONCLUSION: Consideration of modifiable 'triple low' preoperative risk (anaemia, malnutrition, deconditioning) factors and inflammation will improve surgical risk prediction and guide prehabilitation. Gas exchange parameters that focus on VCO2 kinetics at AT and correcting peakVO2 to body surface area (rather than absolute weight) may improve CPET-derived preoperative risk assessment.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

Dispatcher Self-assessment and Attitude Toward Video Assistance as a New Tool in Simulated Cardiopulmonary Resuscitation.

INTRODUCTION: Video-assisted cardiopulmonary resuscitation (V-CPR) describes an advanced telephone-assisted CPR (T-CPR), in which emergency medical service (EMS) dispatchers view a live video steam of the resuscitation. Dispatchers ' general attitudes toward and self-assessment in V-CPR have not been previously investigated. MATERIAL AND METHODS: We conducted this quantitative analysis along with a pilot study on V-CPR. After conducting V-CPR with laypersons in a simulation, EMS dispatchers were given questionnaires with 21 items concerning their personal attitude toward V-CPR and their self-assessment in providing instructions. The actual CPR performance achieved was recorded and compared to the dispatchers' self-assessments. RESULTS: Dispatchers completed 49 questionnaires, and the data is presented descriptively. Over 80% strongly agreed that V-CPR was helpful in guiding and that their feedback improved CPR quality. Fifty-one percent agreed that video images supported them in making a diagnosis, while 44.9% disagreed. A vast majority (80-90% each) strongly agreed that V-CPR helped them recognize CPR issues such as compression point, compression rate, and deterioration. In contrast, data for improved compression depth and release were weaker. Thirty percent found V-CPR to be more stressful or exhausting than T-CPR. A majority stated they would prefer V-CPR as an addition to T-CPR in the future. There was a huge gap between dispatchers' own view of CPR effort and measured CPR quality. CONCLUSION: Dispatchers generally embrace V-CPR and praise the abilities it provides. Our results indicate that the use of V-CPR did not automatically result in an overall improvement in guideline-compliant CPR quality.

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 (<65> 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.

Safety and mid-term surgical results of anterior urethroplasty with the tissue-engineered oral mucosa graft MukoCell® : A single-center experience.

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.

The effects of webcams on German neonatal intensive care units - study protocol of a randomised crossover trial (Neo-CamCare).

BACKGROUND: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences. METHODS: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data. DISCUSSION: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them. TRIAL REGISTRATION: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.

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 ~13.5 mm for a Microcuff internal diameter (ID) size 3.0, ~15 mm for size 3.5, and ~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.

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. TRIAL REGISTRATION: Retrospectively registered: DRKS00021070.

[Oral health assessment of seniors under outpatient care by family doctors : Development and validation of the geriatric outpatient oral health screening]. / Erfassung der Mundgesundheit von ambulant betreuten Senioren durch Hausärzte : Entwicklung und Validierung des geriatrischen ambulanten Mundgesundheits-Screenings.

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.

[Subjective oral health problems of geriatric outpatients and general medical geriatric findings-a pilot study]. / Subjektive Mundgesundheitsprobleme ambulant betreuter geriatrischer Patienten und allgemeinmedizinisch-geriatrische Befunde ­ eine Pilotstudie.

BACKGROUND: Oral health problems of the aged in Germany are not recorded in general practitioner's practices despite a high prevalence. For this purpose, a subjective geriatric outpatient oral health screening (GAMS) is available. AIM: The aim was to clarify whether subjective oral health problems reported by the GAMS can serve as risk indicators for medical findings in geriatric patients. MATERIAL AND METHODS: A total of 75 geriatric patients >75 years old in a family doctor's practice, GAMS, laboratory parameters, e.g. blood count with hemoglobin (g/dl), leukocytes (cells/nl), platelets (cells/nl), sodium (mmol/l), potassium (mmol/l), glucose in serum (mg/dl), HbA1c (HPLC)%, cholesterol (mg/dl) and glomerular filtration rate (GFR, ml/min), Barthel index and timed up and go test (TUG) were carried out. RESULTS: The most common oral health problems were chewing difficulties (19%) and xerostomia (40%). In the case of oral health problems, there were reduced everyday skills (p = 0.066), slower walking speed (0.049), higher serum glucose (p = 0.001) and long-term glucose values (p = 0.002). Bleeding gums are risk indicators for higher leukocyte concentration (p = 0.036). With xerostomia, the hemoglobin value drops by 1.13 g/dl (p = 0.001). DISCUSSION: The GAMS helps to identify oral problems as risk indicators of reduced geriatric health. Also, GAMS can be initiated in cases of the described geriatric pathologies in order to identify possible oral problems.