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Inmunoterapia Adoptiva , Linfoma de Células B Grandes Difuso , Lectina 2 Similar a Ig de Unión al Ácido Siálico , Humanos , Inmunoterapia Adoptiva/métodos , Linfoma de Células B Grandes Difuso/terapia , Linfoma de Células B Grandes Difuso/inmunología , Lectina 2 Similar a Ig de Unión al Ácido Siálico/inmunología , Receptores Quiméricos de Antígenos/inmunología , Receptores de Antígenos de Linfocitos T/inmunologíaRESUMEN
BACKGROUND AND OBJECTIVE: While international guidelines advocate for a multifaceted approach to treating erectile dysfunction (ED) involving physical activities, psychological support, and education, structured programs are infrequent. To address this gap, an app-based therapy was developed, offering a systematic approach. This randomized, single-blind controlled trial aimed to assess the effectiveness of an app-based therapeutic in improving ED. METHODS: A total of 241 patients (49.74, standard deviation 12.73 yr) with ED (International Index of Erectile Function [IIEF]-5 <22) were randomized to the 12-wk app-based therapy (treatment group [TG], n = 122) or a waiting list for the app with continuation of their current management protocol (control group [CG], n = 119). Patients on long-term medication for ED were included, but subsequent exclusion occurred for those starting new medication. Coprimary endpoints were improvements from baseline to 12 wk in erectile function (IIEF-5), disease-related quality of life (QOL-Med-15), and patient activation (Patient Activation Measure [PAM-13]). KEY FINDINGS AND LIMITATIONS: Erectile function (IIEF-5) improved by 4.5 points in the TG versus 0.2 points in the CG (p < 0.0001, 95% confidence interval [CI] 3.4-5.0) group. Quality of life (QOL-Med) improved by 20.5 points in the TG versus -0.0 points in the CG (p < 0.0001, 95% CI 19.2-26.0) group. Patient activation (PAM-13) improved by 11.2 points in the TG versus 0.6 points in the CG (p < 0.0001, 95% CI 9.1-13.6) group. Phosphodiesterase type 5 inhibitor intake had no influence on all observed treatment effects. CONCLUSIONS AND CLINICAL IMPLICATIONS: App-based therapy of patients with ED provided a significant, clinically meaningful improvement. Quality of life and patient activation were also enhanced significantly. This program has the potential to change clinical practice in the treatment of ED. PATIENT SUMMARY: A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.
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ABSTRACT: Graft-versus-host disease (GVHD) occurs in about 10% to 33% of patients receiving "allogeneic" or "autologous" chimeric antigen receptor T (CAR-T) cells after preceding allogeneic hematopoietic stem cell transplantation (allo-HSCT) due to the substantial presence of alloreactive T cells. Extracorporeal photopheresis (ECP) shows promising clinical outcomes in the treatment of GVHD after allo-HSCT without hampering antitumor and antiviral effects. This raises an interesting question: whether ECP might constitute a new way to treat patients with GVHD after CAR T-cell therapy without compromising CAR-T cells significantly. Third-generation CD19-specific CAR-T cells were generated and an in vitro ECP protocol was established. The impact of ECP on CAR-T cells was comprehensively investigated in 2 models: the nondilution model reflects days after CAR T-cell infusion and the dilution model weeks after infusion. The therapeutic effect of ECP on GVHD was examined in an in vitro mixed lymphocyte reaction (MLR) assay. We found, ECP-treated CAR-T cells demonstrated reduced potency in inducing alloreaction compared with that of the group without ECP treatment in MLR assay. ECP could selectively induce apoptosis, thereby enriching the naive and central memory CAR-T cells with a reduced alloreactivity. The cytokine milieu of CAR-T cells could be switched from immune stimulation to immune tolerance in both models. Moreover, ECP could modulate the proliferative capacity of CAR-T cells without hampering their long-term functionality in the dilution model. In conclusion, ECP constitutes a promising treatment strategy for GVHD after allo-HSCT and CAR T-cell transfusion, as ECP reduces the alloreactivity without hampering CAR T-cell functionality.
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Enfermedad Injerto contra Huésped , Inmunoterapia Adoptiva , Fotoféresis , Enfermedad Injerto contra Huésped/terapia , Enfermedad Injerto contra Huésped/etiología , Fotoféresis/métodos , Humanos , Inmunoterapia Adoptiva/métodos , Inmunoterapia Adoptiva/efectos adversos , Receptores Quiméricos de Antígenos , Linfocitos T/inmunología , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trasplante de Células Madre Hematopoyéticas/métodosRESUMEN
INTRODUCTION: Targeting the B cell receptor (BCR) pathway via ibrutinib, a specific inhibitor of Bruton's tyrosine kinase, has shown marked clinical efficacy in treatment of patients with chronic lymphocytic leukemia (CLL), thus becoming a preferred first line option independent of risk factors. However, acquired resistance to ibrutinib poses a major clinical problem and requires the development of novel treatment combinations to increase efficacy and counteract resistance development and clinical relapse rates. CASE PRESENTATION: In this study, we performed exome and transcriptome analyses of an ibrutinib resistant CLL patient in order to investigate genes and expression patterns associated with ibrutinib resistance. Here we provide evidence that ibrutinib resistance can be attributed to aberrant mammalian target of rapamycin (MTOR) signaling. CONCLUSION: Thus, our study proposes that combined use of MTOR inhibitors with ibrutinib could be a possible option to overcome therapy resistance in ibrutinib treated patients.
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AIM: To identify current key areas for nursing research in Switzerland, we revised the Swiss Research Agenda for Nursing (SRAN) initially published in 2008. BACKGROUND: By developing a research agenda, nursing researchers internationally prioritize and cluster relevant topics within the research community. The process should be collaborative and systematic to provide credible information for decisionmakers in health care research, policy, and practice. SOURCES OF EVIDENCE: After a participative, systematic, and critical evaluation within and outside of the Swiss Association for Nursing Science, the updated SRAN 2019-2029 defines four research priorities (new models of care, nursing care interventions, work and care environment, and quality of care and patient safety) and four transversal themes (organization of research, research methodologies, research in health care policy and public health perspectives). CONCLUSION: Adding to other national nursing research agendas, the categories are organized in a framework of key research priorities and transversal themes. They relate to the importance of global and local foci of research as well as challenges in health care services and policy systems. The agenda is an important prerequisite for enhancing the influence of nursing research in Switzerland and provides guidance for the next decade. IMPLICATIONS FOR NURSING PRACTICE: The revised agenda ensures that research projects target key knowledge gaps and the discipline's core questions in respective countries. IMPLICATIONS FOR HEALTH POLICY: Nursing research should inform and influence health policy on all institutional and political levels. Therefore, the integration of public health perspectives in research is one of the most important new aspects of SRAN 2019-2029.
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Investigación en Enfermería , Suiza , Humanos , Política de Salud , Prioridades en Salud , Persona de Mediana Edad , AdultoRESUMEN
The use of the DOS and Delirium Prevalence: a quantitative longitudinal study at a Swiss-German central hospital Abstract: Background: With a prevalence of 12-64%, delirium is a common complication in acute care, associated with negative outcomes such as increased mortality and prolonged length of stay. Many hospitals have guidelines to improve the delirium management. The Delirium Observation Screening Scale (DOS) Score is collected in the study hospital from all patients ≥ 70 years at each shift for at least 3 days. Delirium is diagnosed by a physician and coded according to ICD-10. Purpose: Evaluation of the delirium screening with the DOS according to internal guideline in terms of number of DOS assessments performed, prevalence of delirium (DOS score ≥ 3 points, CD-10 code delirium). Method: This retrospective quantitative single-centre longitudinal study used 2017 and 2018 data of 10046 cases. Statistical analysis methods were used to analyse prevalence of delirium and subgroup comparisons. Results: At least one DOS score was documented in 92% of cases aged ≥ 70-years (n = 5038). DOS implementation varied between 60% in the early, 49% in the late and 38% in the night shift. The prevalence of delirium was 12% according to DOS score ≥ 3 and 4% according to physician diagnosis of a delirium. Cases with a DOS score ≥ 3 were significantly older, more often female, had more comorbidities and were depressed. Conclusions: DOS is performed in most patients when indicated. The DOS implementation frequency varied depending on the shift.
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Delirio , Femenino , Humanos , Delirio/diagnóstico , Delirio/epidemiología , Hospitales , Estudios Longitudinales , Estudios Retrospectivos , Suiza , Masculino , AncianoRESUMEN
Postoperative delirium (POD) remains a common, dangerous and resource-consuming adverse event but is often preventable. The whole peri-operative team can play a key role in its management. This update to the 2017 ESAIC Guideline on the prevention of POD is evidence-based and consensus-based and considers the literature between 01 April 2015, and 28 February 2022. The search terms of the broad literature search were identical to those used in the first version of the guideline published in 2017. POD was defined in accordance with the DSM-5 criteria. POD had to be measured with a validated POD screening tool, at least once per day for at least 3 days starting in the recovery room or postanaesthesia care unit on the day of surgery or, at latest, on postoperative day 1. Recent literature confirmed the pathogenic role of surgery-induced inflammation, and this concept reinforces the positive role of multicomponent strategies aimed to reduce the surgical stress response. Although some putative precipitating risk factors are not modifiable (length of surgery, surgical site), others (such as depth of anaesthesia, appropriate analgesia and haemodynamic stability) are under the control of the anaesthesiologists. Multicomponent preoperative, intra-operative and postoperative preventive measures showed potential to reduce the incidence and duration of POD, confirming the pivotal role of a comprehensive and team-based approach to improve patients' clinical and functional status.
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Anestesiología , Delirio , Delirio del Despertar , Adulto , Humanos , Delirio del Despertar/diagnóstico , Delirio del Despertar/epidemiología , Delirio del Despertar/etiología , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Delirio/diagnóstico , Delirio/epidemiología , Delirio/etiología , Consenso , Cuidados Críticos , Factores de RiesgoRESUMEN
Background: Studies have shown that nurses do not complete one or more necessary nursing care elements in their last shift due to lack of time. The Basel Extent of Rationing Nursing Care (BERNCA) instrument is one of the most used scales to measure the rationing of nursing care. Aim: This study is aimed to culturally adapt the revised BERNCA (BERNCA-R) instrument to the Turkish language and to test its validity and reliability. Methods: A cross-sectional and methodological study was used. The instrument was adapted in three stages: translation and adaptation, content validity testing and validity and reliability. Data were obtained from 350 nurses working in two public acute care hospitals in Turkey, between September 2019 and January 2020. The descriptive statistics, content validity index, exploratory and confirmatory factor analyses, Cronbach's α, Guttman split-half and inter-item reliability analyses were performed for the analysis of the data. Results: The Turkish version of the BERNCA-R instrument with a 27-item and three-subscales (monitoring, daily care and needs and psychosocial care) structure was found to have acceptable and good fit indices. Conclusion: The Turkish version of the BERNCA-R instrument is valid and reliable tool to measure rationing of nursing care.
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Postoperative delirium (POD) is an adverse but often preventable complication of surgery and surgery-related anaesthesia, and increasingly prevalent. This article provides an overview on non-pharmacological preventive measures, divided into individualized and non-individualized measures. Non-individualized measures, such as the most minimally invasive surgical procedure, avoidance of unnecessary fasting before surgery, and the most tolerable anaesthesia are used to minimize the risk of POD in all patients. Based on the results of preoperative screenings for risk factors such as frailty or cognitive impairment, individualized measures may encompass prehabilitation, treatment of specific risk factors, operation room companionship or cognitive, motor, and sensory stimulation as well as social support. This article additionally lists several examples of best practice approaches already implemented in German-speaking countries and websites for further readings.
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Anestesia , Anestesiología , Delirio del Despertar , Fragilidad , Humanos , Delirio del Despertar/prevención & control , AyunoRESUMEN
BACKGROUND: Third-generation chimeric antigen receptor (CAR)-engineered T cells (CARTs) might improve clinical outcome of patients with B cell malignancies. This is the first report on a third-generation CART dose-escalating, phase-1/2 investigator-initiated trial treating adult patients with refractory and/or relapsed (r/r) acute lymphoblastic leukemia (ALL). METHODS: Thirteen patients were treated with escalating doses of CD19-directed CARTs between 1 × 106 and 50 × 106 CARTs/m2. Leukapheresis, manufacturing and administration of CARTs were performed in-house. RESULTS: For all patients, CART manufacturing was feasible. None of the patients developed any grade of Immune effector cell-associated neurotoxicity syndrome (ICANS) or a higher-grade (≥ grade III) catokine release syndrome (CRS). CART expansion and long-term CART persistence were evident in the peripheral blood (PB) of evaluable patients. At end of study on day 90 after CARTs, ten patients were evaluable for response: Eight patients (80%) achieved a complete remission (CR), including five patients (50%) with minimal residual disease (MRD)-negative CR. Response and outcome were associated with the administered CART dose. At 1-year follow-up, median overall survival was not reached and progression-free survival (PFS) was 38%. Median PFS was reached on day 120. Lack of CD39-expression on memory-like T cells was more frequent in CART products of responders when compared to CART products of non-responders. After CART administration, higher CD8 + and γδ-T cell frequencies, a physiological pattern of immune cells and lower monocyte counts in the PB were associated with response. CONCLUSION: In conclusion, third-generation CARTs were associated with promising clinical efficacy and remarkably low procedure-specific toxicity, thereby opening new therapeutic perspectives for patients with r/r ALL. Trial registration This trial was registered at www. CLINICALTRIALS: gov as NCT03676504.
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Síndromes de Neurotoxicidad , Humanos , Adulto , Leucaféresis , Proteínas Adaptadoras Transductoras de Señales , Antígenos CD19/uso terapéuticoRESUMEN
Delirium incidence and phenotype differ between sexes. Sex differences in the selection of treatment strategies remain elusive. We evaluated sex-specific responses to non- and pharmacological management. In this observational prospective cohort study conducted at the University Hospital Zurich, Switzerland, 602 patients managed for delirium were analyzed. Remission and benefit ratios of treatments were calculated using Cox regression models. Baseline characteristics were similar in both sexes. Overall, 89% of all patients (540/602) received pharmacological management for delirium, most (77%) with one or two different medications. An equal number of male and female patients had either no medication ( P â =â 0.321) or three and more medications ( P â =â 0.797). Men had two different medications more often ( P â =â 0.009), while women more frequently received one medication ( P â =â 0.037). Remission rates within 20 days were higher in non-pharmacological treatment and similar between sexes, with odds of 1.36 in females, and 2.3 in males. Non-pharmacological treatment was equally efficacious in both sexes. Women who received supportive treatment and monotherapy had equal odds of remission. Men fared better with supportive care compared to pharmacologic therapies. Remission rates with different management strategies were similar between sexes. No sex differences were found regarding phenotypes, clinical course, and response to therapy.
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Delirio , Humanos , Masculino , Femenino , Anciano , Estudios Prospectivos , Delirio/diagnóstico , Delirio/tratamiento farmacológico , Delirio/epidemiología , Caracteres SexualesRESUMEN
Hematological toxicity is the most common adverse event after chimeric antigen receptor (CAR) T-cell therapy. Cytopenias can be profound and long-lasting and can predispose for severe infectious complications. In a recent worldwide survey, we demonstrated that there remains considerable heterogeneity in regard to current practice patterns. Here, we sought to build consensus on the grading and management of immune effector cell-associated hematotoxicity (ICAHT) after CAR T-cell therapy. For this purpose, a joint effort between the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA) involved an international panel of 36 CAR T-cell experts who met in a series of virtual conferences, culminating in a 2-day meeting in Lille, France. On the basis of these deliberations, best practice recommendations were developed. For the grading of ICAHT, a classification system based on depth and duration of neutropenia was developed for early (day 0-30) and late (after day +30) cytopenia. Detailed recommendations on risk factors, available preinfusion scoring systems (eg, CAR-HEMATOTOX score), and diagnostic workup are provided. A further section focuses on identifying hemophagocytosis in the context of severe hematotoxicity. Finally, we review current evidence and provide consensus recommendations for the management of ICAHT, including growth factor support, anti-infectious prophylaxis, transfusions, autologous hematopoietic stem cell boost, and allogeneic hematopoietic cell transplantation. In conclusion, we propose ICAHT as a novel toxicity category after immune effector cell therapy, provide a framework for its grading, review literature on risk factors, and outline expert recommendations for the diagnostic workup and short- and long-term management.
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Hematología , Trasplante de Células Madre Hematopoyéticas , Consenso , Inmunoterapia Adoptiva , Factores InmunológicosRESUMEN
OBJECTIVE: Patient sitters are frequently used in acute care hospitals to provide one-to-one care for agitated or disorientated patients to assure the safety and well-being of patients. However, there is still a lack of evidence on the use of patient sitters, especially in Switzerland. Therefore, the aim of this study was to describe and explore the use of patient sitters in a Swiss acute care hospital. METHODS: In this retrospective, observational study we included all inpatients who were hospitalized between January and December 2018 in a Swiss acute care hospital and required a paid or volunteer patient sitter. Descriptive statistics were used to describe the extent of patient sitter use, patient characteristics, and organizational factors. For the subgroup analysis between internal medicine and surgical patients Mann-Whitney U tests and chi-square tests were used. RESULTS: Of the total of 27'855 included inpatients, 631 (2.3%) needed a patient sitter. Of these, 37.5% had a volunteer patient sitter. The median patient sitter duration per patient per stay was 18.0 hours (IQR = 8.4-41.0h). The median age was 78 years (IQR = 65.0-86.0); 76.2% of patients were over the age of 64. Delirium was diagnosed in 41% of patients, and 15% had dementia. Most of the patients showed signs of disorientation (87.3%), inappropriate behavior (84.6%), and risk of falling (86.6%). Patient sitter uses varied during the year and between surgical and internal medicine units. CONCLUSIONS: These results add to the limited body of evidence concerning patient sitter use in hospitals, supporting previous findings related to patient sitter use for delirious or geriatric patients. New findings include the subgroup analysis of internal medicine and surgical patients, as well as analysis of patient sitter use distribution throughout the year. These findings may contribute to the development of guidelines and policies regarding patient sitter use.
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Etnicidad , Pacientes Internos , Anciano , Humanos , Confusión , Hospitales , Estudios Retrospectivos , Suiza , Anciano de 80 o más AñosRESUMEN
Accurate somatic variant calling from next-generation sequencing data is one most important tasks in personalised cancer therapy. The sophistication of the available technologies is ever-increasing, yet, manual candidate refinement is still a necessary step in state-of-the-art processing pipelines. This limits reproducibility and introduces a bottleneck with respect to scalability. We demonstrate that the validation of genetic variants can be improved using a machine learning approach resting on a Convolutional Neural Network, trained using existing human annotation. In contrast to existing approaches, we introduce a way in which contextual data from sequencing tracks can be included into the automated assessment. A rigorous evaluation shows that the resulting model is robust and performs on par with trained researchers following published standard operating procedure.
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Aprendizaje Automático , Redes Neurales de la Computación , Humanos , Reproducibilidad de los Resultados , Secuenciación de Nucleótidos de Alto Rendimiento/métodosRESUMEN
BACKGROUND: There is a strong within-subject alteration of semen parameters in men with infertility. However, it remains unknown in which subgroup variations are likely to occur and which semen parameters are affected. OBJECTIVE: To evaluate parameters associated with spontaneous alterations in semen analysis. PATIENTS AND METHODS: We retrospectively selected 3456 men with infertility without known causes affecting spermatogenesis or sperm output for analysis of repeated ejaculate samples. Exclusion criteria comprised sperm concentration <1 million/mL, abnormal follicle-stimulating hormone or low testosterone, and low bitesticular volume (<10 mL). Grouped linear two-level nested mixed-effect models were applied. The analyzed parameters included abstinence time, bitesticular volume, age, accessory gland markers, follicle-stimulating hormone, and FSHB c.-211 variants. RESULTS: Groups include A (n = 397): ≥1.0 to <5.0 million/mL, B (n = 708): ≥5.0 to <15.0 million/mL, and C (n = 2351): ≥15.0 million/mL. Groups A, B, and C: changes in ejaculate volume were associated with alterations in total sperm count and motility (p < 0.003). Changes were, controlled for abstinence time (p < 0.001), related to α-glucosidase, fructose, or zinc (p = 0.005-0.02). Group A + B: fluctuations in follicle-stimulating hormone level influenced sperm concentration/count (p = 0.004-0.02), albeit only in men with FSHB c.-211 GG (p = 0.007-0.02). T-allele carriers did not show changes in follicle-stimulating hormone levels (p > 0.1). Group B: age <50 years (p = 0.007-0.01) and normal bitesticular volume (p = 0.008-0.02) were associated with spontaneous increases in sperm concentration, count, and motility. CONCLUSION: Semen parameters exhibit intra-individual alterations associated with organic, hormonal, and genetic variables. Changes are pronounced in younger men with normal bitesticular volume and oligozoospermia to almost normozoospermia. The effect is modulated by abstinence time, accessory gland function, and fluctuations in follicle-stimulating hormone level, which is bound to FSHB c.-211G>T variant. Judgment of semen analysis should be based on two semen samples, with abstinence times between 4 and 5 days. As a future perspective, it might be investigated whether younger men with normal bitesticular volume who are unable to elicit increases in serum follicle-stimulating hormone (FSHB c.-211 genotype of GT/TT) benefit from improving accessory gland function and increasing follicle-stimulating hormone.
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Oligospermia , Semen , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Polimorfismo de Nucleótido Simple , Hormona Folículo Estimulante , Hormona Folículo Estimulante Humana , Recuento de Espermatozoides , Testosterona , Motilidad EspermáticaRESUMEN
Increasing evidence suggests that the gut microbiome may modulate the efficacy of cancer immunotherapy. In a B cell lymphoma patient cohort from five centers in Germany and the United States (Germany, n = 66; United States, n = 106; total, n = 172), we demonstrate that wide-spectrum antibiotics treatment ('high-risk antibiotics') prior to CD19-targeted chimeric antigen receptor (CAR)-T cell therapy is associated with adverse outcomes, but this effect is likely to be confounded by an increased pretreatment tumor burden and systemic inflammation in patients pretreated with high-risk antibiotics. To resolve this confounding effect and gain insights into antibiotics-masked microbiome signals impacting CAR-T efficacy, we focused on the high-risk antibiotics non-exposed patient population. Indeed, in these patients, significant correlations were noted between pre-CAR-T infusion Bifidobacterium longum and microbiome-encoded peptidoglycan biosynthesis, and CAR-T treatment-associated 6-month survival or lymphoma progression. Furthermore, predictive pre-CAR-T treatment microbiome-based machine learning algorithms trained on the high-risk antibiotics non-exposed German cohort and validated by the respective US cohort robustly segregated long-term responders from non-responders. Bacteroides, Ruminococcus, Eubacterium and Akkermansia were most important in determining CAR-T responsiveness, with Akkermansia also being associated with pre-infusion peripheral T cell levels in these patients. Collectively, we identify conserved microbiome features across clinical and geographical variations, which may enable cross-cohort microbiome-based predictions of outcomes in CAR-T cell immunotherapy.
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Microbioma Gastrointestinal , Linfoma de Células B , Receptores Quiméricos de Antígenos , Humanos , Microbioma Gastrointestinal/genética , Inmunoterapia , Inmunoterapia Adoptiva/efectos adversos , Linfocitos T , Antígenos CD19RESUMEN
Evaluation of the implementation of non-pharmacological measures for the prevention and treatment of delirium: A retrospective cohort study Abstract. Background: Delirium is burdensome for the affected patients, their relatives, hospital staff and the health care system. Preventing delirium with targeted multicomponent interventions is therefore essential. Aim: To investigate the implementation of defined non-pharmacological, preventive, and supportive measures in patients with an increased risk of delirium and/or delirium by the hospital's directions. Methods: In this observational study, routine data from 175 hospitalized patients were included. Data on delirium prevention, treatment and presence of delirium were extracted from the patient records and analyzed using appropriate statistical methods. Group comparisons were made between the medical/surgical clinic and the delirium/no delirium group. Results: Of the 175 patients, 31 had delirium. For delirium prevention, measures to improve oxygen supply, excretion, pain and mobility were most frequently implemented and measures such as improving cognition and communication were least frequently implemented. In the case of delirium, measures to modify risk factors, ensure safety, as well as prophylaxis were applied most frequently. Between the two clinics and between the delirium/no delirium group significant differences in the frequency of these measures were shown. Conclusion: The differences in frequency of implementation provide preliminary evidence that clinic-specific delirium prevention, early detection, and treatment may be needed.
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Atención a la Salud , Humanos , Estudios RetrospectivosRESUMEN
AIM: Nurse-led care aims to optimize the discharge preparation with a focus on increasing patients' independency and self-care abilities. This study compared patients' improvements of self-care abilities and frequency of readmission rate between nurse-led care and regular nursing care within the acute hospital setting. DESIGN: A quasi-experimental design within a real-world setting was used for this work. METHODS: We included a pool of 2501 patients from a control group (medically stable in usual care) and 420 patients from an intervention group (nurse-led care). After propensity score matching, the study cohort consisted of 612 patients. RESULTS: From admission to discharge, nurse-led care patients showed superior improvements of total self-care abilities compared to usual care patients. In particular, we found improvements in the following categories: mobility, grooming and excretion. Patients with nurse-led care were furthermore less frequently readmitted to hospital compared with the control group patients. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.
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Rol de la Enfermera , Autocuidado , Humanos , Readmisión del Paciente , Relaciones Enfermero-Paciente , Alta del PacienteRESUMEN
INTRODUCTION: Donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation. In a phase I clinical trial (TOL-1 Study), MIC treatment resulted in a cellular phenotype that was directly and indirectly suppressive to the recipient's immune system allowing for reduction of conventional immunosuppressive therapy. Here, we describe a protocol for a randomised controlled, multicentre phase-IIb clinical trial of individualised immunosuppression with intravenously administered donor MIC compared with standard-of-care (SoC) in living donor kidney transplantation (TOL-2 Study). METHODS AND ANALYSIS: Sixty-three living donor kidney transplant recipients from six German transplant centres are randomised 2:1 to treatment with MIC (MIC group, N=42) or no treatment with MIC (control arm, N=21). MIC are manufactured from donor peripheral blood mononuclear cells under Good Manufacturing Practice conditions. The primary objective of this trial is to determine the efficacy of MIC treatment together with reduced conventional immunosuppressive therapy in terms of achieving an operational tolerance-like phenotype compared with SoC 12 months after MIC administration. Key secondary endpoints are the number of patient-relevant infections as well as a composite of biopsy-proven acute rejection, graft loss, graft dysfunction or death. Immunosuppressive therapy of MIC-treated patients is reduced during follow-up under an extended immunological monitoring including human leucocyte antigen-antibody testing, and determination of lymphocyte subsets, for example, regulatory B lymphocytes (Breg) and antidonor T cell response. A Data Safety Monitoring Board has been established to allow an independent assessment of safety and efficacy. ETHICS AND DISSEMINATION: Ethical approval has been provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg, Heidelberg, Germany (AFmu-580/2021, 17 March 2022) and from the Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Institute, Langen, Germany (Vorlage-Nr. 4586/02, 21 March 2022). Written informed consent will be obtained from all patients and respective donors prior to enrolment in the study. The results from the TOL-2 Study will be published in peer-reviewed medical journals and will be presented at symposia and scientific meetings. TRIAL REGISTRATION NUMBER: NCT05365672.