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Background: Traditional fasting rules for children prior to elective operations ("6‑4‑2 rule") often lead to prolonged fasting times with possible adverse events (discomfort, hypoglycemia, metabolic disorders, agitation/delirium). A new liberal fasting policy allowing children to drink clear fluids until being called to the operating room ("6‑4‑0") was established in our university hospital. This article describes our experiences and retrospectively examines the effects., Objective: Evaluation of real fasting times before and up to 6 months after the intervention (success and durability of changing fasting policy). Evaluation of impact on outcome parameters, such as patients' resp. parents' satisfaction as well as perioperative agitation, arterial hypotension after induction and postoperative nausea and vomiting (PONV)., Material and Methods: Retrospective evaluation of methods and interventions from 1 month before to 6 months after changing the fasting policy (June-December 2020). Statistical analysis using descriptive statistics, odds ratio and χ 2 -test., Results: Of 216 analyzed patients 44 were in the pre-change group and 172 in the post-change group. We could significantly reduce clear fluids fasting times over the 6 months after the intervention (median fasting time: from 6.1 h to 4.5 h; p = 0.034) and achieve our aim (fasting time for clear fluids less than or equal to 2h) in 47% of the patients. Fasting times became longer again reaching pre-change intervals in the 4th and 5th month, so reminder measures turned out to be necessary. By reminding the staff we could reduce fasting times again in the 6th month and restore patients' resp. parents' satisfaction. Satisfaction was improved by shorter fasting times (median school grade from 2.8 to 2.2; p = 0.004; odds ratio for better satisfaction 5.24, 2.1-13.2), and preoperative agitation was reduced (agitation modified PAED scale 1-2 in only 34.5% instead of 50%, p = 0.032). In the liberal fasting group, we observed a nonsignificant smaller incidence of hypotension after induction (7% vs. 14%, p = 0.26) while PONV was too rare in both groups for statistical purposes., Conclusion: With multiple interventions we could significantly reduce fasting times for clear fluids and improve patients' resp. parents' satisfaction as well as preoperative agitation. These interventions included regular presence in all staff meetings, a handout for both parents and staff, as well as a remark on the anesthesia protocol. Children who were operated on later in the day, benefited most from the new liberal fasting policy as they were allowed to drink until being called to the operating room. Following our experience, we consider simple and safe fasting rules for the whole staff as most important for change management. Nevertheless, we could not reduce the fasting intervals in all cases and had to remind the staff after 5 months to preserve this success. For enduring success, we suggest regular staff updates during the change process instead of one single kick-off information event., (© 2023. The Author(s).)

Background: Multimorbidity is a common phenomenon among patients treated in general practices. Key challenges within this group include functional difficulties, polypharmacy, treatment burden, fragmentation of care, reduced quality of life and increased health care utilization. These problems cannot be solved in the short consultation time of a general practitioner (GP) since there is an increasing shortage of GPs. In many countries, advanced practice nurses (APNs) are successfully integrated into primary health care for multimorbid patients. The objective of this study is to examine whether the integration of APNs in the primary care of multimorbid patients in Germany leads to optimized care of the target group and to a reduction in the workload of the GPs., Methods: The intervention includes the integration of APNs into the care for multimorbid patients in general practice for twelve months. Qualifications for APNs include a master's level academic degree and 500 hours of project-specific training. Their tasks include in-depth assessment, preparation, implementation, monitoring and evaluation of a person-centred and evidence-based care plan. In this nonrandomized controlled trial, a prospective multicentre mixed methods study will be performed. The main inclusion criterion was the cooccurrence of three chronic diseases. For data collection in the intervention group (n = 817), routine data from health insurance companies and association of statutory health insurance physicians (ASHIP) will be used, as well as qualitative interviews. In addition, the intervention will be assessed through documentation of the care process and standardized questionnaires using a longitudinal design. The control group (n = 1634) will receive standard care. For the evaluation, routine data from health insurance companies are matched at a ratio of 1:2. Outcomes will be measured using emergency contacts and GP visits, treatment costs, health status of the patients and the satisfaction of parties involved. The statistical analyses will include Poisson regression to compare outcomes between the intervention and control groups. Descriptive and analytical statistical methods will be used in the longitudinal analysis of the intervention group data. Cost analysis will compare total costs and subgroup costs between the intervention and control groups. Qualitative data will be analysed using content analysis., Discussion: Challenges to this protocol could include the political and strategic environment as well as the planned number of participants., Trial Registration: DRKS00026172 on DRKS., (© 2023. The Author(s).)

Purpose: Supervised exercise is a potentially promising supportive care intervention for people with metastatic breast cancer (MBC), but research on the patients' perspective is limited. The aim of the current focus group study was to gain an in-depth understanding of MBC patients' perceived barriers, facilitators, and preferences for supervised exercise programs., Methods: Eleven online focus groups with, in total, 44 MBC patients were conducted in four European countries (Germany, Poland, Spain, Sweden). Main topics of the semi-structured discussions covered attitudes towards participation in supervised exercise programs, perceived facilitators, experienced barriers, and exercise preferences. Interviews were transcribed verbatim, translated into English, and coded based on a preliminary coding framework, supplemented by themes emerging during the sessions. The codes were subsequently examined for interrelations and re-organized into overarching clusters., Results: Participants had positive attitudes towards exercise, but experienced physical limitations and insecurities that inhibited their participation. They expressed a strong desire for exercise tailored to their needs, and supervision by an exercise professional. Participants also highlighted the social nature of group training as an important facilitator. They had no clear preference for exercise type, but rather favored a mixture of different activities. Flexible training modules were considered helpful to increase exercise program adherence., Conclusions: MBC patients were generally interested in supervised exercise programs. They preferred group exercise that facilitates social interaction, but also expressed a need for individualized exercise programs. This suggests the relevance to develop flexible exercise programs that are adjusted to the individual's needs, abilities, and preferences., (© 2023. The Author(s).)

Background and purpose - Knee and hip replacement are common and increasing procedures, and an optimized care process that could be implemented in different settings would be useful. The PROMISE trial investigates whether a new care process works equally in different German settings and how the results compare with current non-standardized care.Patients and methods - This multi-center prospective mixed-method study includes 2,000 German patients receiving arthritis-related hip or knee endoprostheses. An interdisciplinary and cross-sectoral care process was developed and implemented in 3 German hospitals with different levels of care, and corresponding rehabilitation centers were included to bridge the gap after acute care.Duration and outcome - The PROMISE trial recruited patients between May 2018 and March 2020. Follow-up will end in February 2021. Assessments are performed at: examination on clinical indication, 1 week before surgery, on the day of surgery, at the end of hospitalization, end of the rehabilitation program, and 3 months, 6 months, and 12 months after surgery. Outcomes include patient-reported outcomes, medical examination findings, and routinely collected data regarding the surgery and complications. Guideline-based interviews are conducted with selected patients and care partners. The primary endpoint is the presence of chronic pain at 12 months after surgery. Secondary endpoints are the number of recognized pre-existing conditions, physical activity at 12 months after surgery, use of medical services, quality of life, and interactions between care partners.Trial registration - The trial is registered with the German Clinical Trials Register (https://www.drks.de; DRKS00013972; March 23, 2018).

Since the beginning of the COVID-19 pandemic, data have been accumulated to examine excess mortality in the first half of 2020. Mortality in the preceding year or years is used to calculate the expected number of deaths, which is then compared with the actual number of deaths in 2020. We calculated weekly age- and sex-specific mortality rates for 93.1% of the Italian municipalities for the years 2015-2019 and for the first 26 weeks in 2020. We assumed the mortality experience during 2015-2019 as the reference period to calculate standardised mortality ratios. Furthermore, in order to compare the mortality experience of males and females, we calculated sex- and age- specific weekly direct standardised mortality rates and differences between the observed and expected number of deaths. We observed considerable changes in the demographics in the Italian population between the years 2015 and 2020, particularly among people 60 years and older and among males. The population is aging and the proportion of elderly males has increased, which was not reflected adequately in previous estimates of excess mortality. Standardized excess mortality results show that in Italy between the 8th and 26th weeks in 2020, there were 33,035 excess deaths, which is only 643 fewer deaths than the official COVID-19 death toll for this time period. A comparative increase in the mortality rates was observed in March among both sexes, but particularly for males. Comparisons with recently published data show considerably higher excess deaths, but these data were either not covering the complete country or did not account for age and sex. Neglecting the demographic changes in a region, even over a short time span, can result in biased estimates.

Purpose: The number of total hip (THA) and knee arthroplasties (TKA) grows constantly which causes enormously rising costs for healthcare systems. The aim of this systematic literature review was to evaluate whether a cost reduction can be achieved by THA or TKA fast-track protocols, which is a multidisciplinary approach aiming at faster recovery., Methods: A systematic literature research was undertaken for the timeframe from 2007/01/01 to 2019/03/04 in PubMed. Abstracts and title of the identified records were checked for eligible criteria and afterward the full text was assessed., Results: Seven studies were included in the review. All studies showed a reduction in the total cost for fast-track THA and TKA. Most studies based their cost calculations on the amount of days the patients spend in the hospital., Conclusion: Using a fast-track protocol can significantly reduce the overall costs of the treatment.

Urine metabolomic profiling can identify biochemical alterations resulting from various injuries affecting the graft outcome after renal transplantation. Here, we aimed to describe in depth the metabolite content of urines of renal transplant patients and to link it with the major injury factors acting at critical stages following transplantation. Morning urine samples were prospectively collected from 38 kidney transplant patients at 7 days (D7), 3 months (M3) and 12 months (M12) after transplantation. Twenty-five patients were treated with tacrolimus (Tac) and thirteen patients with cyclosporine (CsA). (1)H-NMR (proton nuclear magnetic resonance) and gas chromatography-mass spectrometry (GC-MS) were used to examine the overall metabolomic signature of each sample. Multivariate analysis was performed to study the changes in the metabolic profile over time and their dependency on the type of calcineurin inhibitor (CNI) administered to patients. Biological pathways affected by transplantation were identified using a metabolomics pathway analysis (MetPA) web-tool. The metabolic profile of urine samples clearly varied with time. Markers of medullary injury, tubule cell oxidative metabolism and impaired tubular reabsorption or secretion were present at D7. Differences in metabolic profiles became less marked as time passed on, urine content being quite similar at M3 and M12. The metabolite profile tended to differ between patients receiving Tac and those receiving CsA but no clear discriminating profiles can be found. The combination of (1)H-NMR and GC-MS for the analysis of urine metabolomic profiles is a very useful method to study patho-physiological alterations in kidney transplant patients over time.

Rituximab may induce positive B-cell complement-dependent cytotoxicity crossmatch (CDC-XM) in the absence of donor-specific antibodies, as we report in these two cases. We retrospectively assessed the in vitro concentration-effect relationship of rituximab in sera. B-cell CDC-XM results were positive only in the presence of rituximab, even with low concentrations (inferior to 1 μg/mL). Moreover, rituximab neutralization with increasing concentration of an anti-rituximab-idiotype monoclonal antibody progressively reduced B-cell lysis. In conclusion, measurement of rituximab content may be useful to identify sera at risk of misinterpretation in immunized patients., (Copyright © 2013 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.)

Pancreatic cancer is one of the most aggressive tumours. Despite enormous progress in multimodal therapeutic options, surgical resection remains the only chance for curative treatment. Several surgical procedures have been developed with the intention to improve the outcome of this disease. One of these procedures is extended lymphadenectomy. Another is the resection of main arterial or venous vessels, in case of tumour infiltration. So far there is no pivotal proof of any survival advantage of extended lymphadenectomy over standard pancreaticoduodenectomy. On the contrary there even exists evidence that an extended lymphadenectomy might increase morbidity. In case of tumour infiltration of the portal or the superior mesenteric vein, survival seems to be improved by resection of the affected vessel. Resection of the portal vein can be done safely without affecting morbidity or mortality. In the presence of tumour infiltrating the hepatic artery or other arterial vessels, there is still a need for controlled clinical trials to confirm any survival benefit from arterial resection.

Urine samples of 31 probands who had come in conflict with the Dangerous Drugs act and therefore had to take part in urinalysis tests where analysed during a period of 34 months. The purpose of this study was to find out whether urinalysis testing can reduce drug abuse. The urine samples were tested on morphine/codeine, cannabis and barbiturates. 28 out of 31 persons were to be tested on morphine, 13 on cannabis and 26 on barbiturates. 32% of the persons tested on morphine showed no positive results during the whole period of investigation. 3% had continuous relapses (greater than 30% positive results) during this time. A significant (x2 = 28.98) decrease of positive samples at the end of the investigation period was found. The tests on barbiturates showed no significant (x2 = 0) influence of the urinalysis on the frequency of positive results. Tests on cannabis showed a slightly significant (x2 = 4.26) increase of positive results at the end of the investigation period. Most of the test persons showed an obvious improvement of their social and family conditions during this period.