[S3 Guideline: Treating Chronic Respiratory Failure with Non-invasive Ventilation].

The S3 guideline on non-invasive ventilation as a treatment for chronic respiratory failure was published on the website of the Association of the Scientific Medical Societies in Germany (AWMF) in July 2024. It offers comprehensive recommendations for the treatment of chronic respiratory failure in various underlying conditions, such as COPD, thoraco-restrictive diseases, obesity-hypoventilation syndrome, and neuromuscular diseases. An important innovation is the separation of the previous S2k guideline dating back to 2017, which included both invasive and non-invasive ventilation therapy.

INDUCE-2: A Phase I/II, open-label, two-part study of feladilimab in combination with tremelimumab in patients with advanced solid tumors.

Combining immunotherapies with distinct mechanisms of action has the potential to overcome treatment resistance and improve outcomes. The inducible T-cell co-stimulator (ICOS) agonist feladilimab is directed at enhancing T-cell activation and function, thereby promoting an antitumor response. INDUCE-2 (NCT03693612) was a Phase I/II, open-label, two-part study evaluating the anti-ICOS agonist feladilimab in combination with the anti-CTLA-4 antibody tremelimumab in patients with select advanced solid tumors.

Anterior Fusion and Long-Term Cervical Mobility in Patients With Traumatic Spinal Cord Injury: An Observational Study.

Objective This study aims to determine and quantify the impairment of cervical mobility and range of motion in patients with traumatic spinal cord injury (SCI) and subsequent cervical subaxial fusion surgery. Methods A total of 89 patients who underwent interbody fusion of the cervical spine and were admitted to the Spinal Cord Injury Center of the BG Klinikum Hamburg, Germany between 2003 and 2018 were examined after their in-facility rehabilitation was successfully completed. Reclination, inclination, tilt, and rotation of the cervical spine were examined and documented in addition to overall patient characteristics and fusion extent.

Demographics and functional outcome of shallow water diving spinal injuries in northern Germany - A retrospective analysis of 160 consecutive cases.

Aim: To describe demographic findings, typical injuries and functional neurological outcomes in patients with cervical trauma and tetraplegia sustained after diving into shallow water.

Patients And Methods: A retrospective study was performed including all patients treated in BG Klinikum Hamburg suffering from tetraplegia after jumping into shallow water between 1st June 1980 and 31st July 2018.

Results: One hundred and sixty patients with cervical spinal injuries and tetraplegia following a dive into shallow water were evaluated.

Incidence of spinal cord injuries in Germany.

Purpose: The goal of this study was to provide recent data on incidence of spinal cord injuries (SCI) in Germany.

Methods: The source of information was data collected via the mandatory submission of ICD-10 GM Codes by German public hospitals after patient discharge. Data from 2013 to 2020 were retrieved from the databases of the Federal Bureau of Statistics.

Designing a Visit Schedule for Longitudinal Studies in Pediatric Research.

A challenge for longitudinal studies is combining individual assessments into visits that are scientifically logical, not burdensome for participants, well-choreographed, and operationally feasible. The visits then need to be sequenced and spaced to address the scientific goals and generate a data archive that is sufficiently robust and well-documented to support subsequent analyses. This paper summarizes comprehensive multi-disciplinary activities that were coordinated to design the content, format, and structure of the National Children's Study and concurrently serve as a model and resource for other studies.

Phrenic nerve stimulation experiences. A single centre, controlled, prospective study.

Patients with central apnoea may use electro ventilation, provided their phrenic nerves and diaphragm muscles are normal. A tendency towards better survival has been found, and both an improved quality of life and facilitated nursing have been claimed with electro ventilation compared to mechanical ventilation. The high investment for the device may form a hurdle for fund providers like our hospital administration board.

Long-Term Survival and Causes of Death in Patients below the Age of 60 with Traumatic Spinal Cord Injury in Germany.

To study the mortality, cause and risk indicators of death in German patients with traumatic spinal cord injury, patients with traumatic spinal cord injury admitted to Berufsgenossenschaftliches Trauma Hospital Hamburg between 1 January 1997 and 31 December 2018, aged between 16 and 60 with a minimal survival of one year after injury, were included. Further criteria were the absence of life-limiting comorbidities at the time of injury. 223 deceased patients with traumatic spinal cord injury were identified, investigated on and partly compared to the surviving subjects.

NCS Assessments of the Motor, Sensory, and Physical Health Domains.

As part of the National Children's Study (NCS) comprehensive and longitudinal assessment of the health status of the whole child, scientific teams were convened to recommend assessment measures for the NCS. This manuscript documents the work of three scientific teams who focused on the motor, sensory, or the physical health aspects of this assessment. Each domain team offered a value proposition for the importance of their domain to the health outcomes of the developing infant and child.

Principles of Researching Health Disparities in Longitudinal Cohort Studies Enrolling Children.

Health disparities are defined on the basis of specific populations that, when compared to the general population, have a significant disparity on the rate of disease incidence, prevalence, morbidity, mortality, or survival. People that experience health disparities can be defined by multiple criteria. As the diversity of the United States broadens and increases, research on the origins and causes of health disparities becomes more important to support a healthy general population.

Health Measurement Model-Bringing a Life Course Perspective to Health Measurement: The PRISM Model.

Health is a multidimensional concept that is challenging to measure, and in the rapidly evolving developmental changes that occur during the first 21 years of human life, requires a dynamic approach to accurately capture the transitions, and overall arc of a complex process of internal and external interactions. We propose an approach that integrates a lifecourse framework with a layered series of assessments, each layer using a many to many mapping, to converge on four fundamental dimensions of health measurement-Potential, Adaptability, Performance, and Experience. The four dimensions can conceptually be mapped onto a plane with each edge of the resulting quadrilateral corresponding to one dimension and each dimensions assessment calibrated against a theoretical ideal.

Urinary bladder cancer as a late sequela of traumatic spinal cord injury.

Background: Traumatic spinal cord injury (SCI) is also a combat-related injury that is increasing in modern warfare. The aim of this work is to inform medical experts regarding the different course of bladder cancer in able-bodied patients compared with SCI patients based on the latest medical scientific knowledge, and to present decision-making aids for the assessment of bladder cancer as a late sequela of traumatic SCI.

Methods: A study conducted between January 1998 and December 2019 in the BG Trauma Hospital Hamburg formed the basis for the decision-making aids.

Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries.

Introduction: Pneumonia is one of the leading complications and causes of death after a spinal cord injury (SCI). After a cervical or thoracic lesion, impairment of the respiratory muscles decreases respiratory function, which increases the risk of respiratory complications. Pneumonia substantially reduces patient's quality of life, may prolong inpatient rehabilitation time, increase healthcare costs or at worse, lead to early death.

Prerequisites to support high-quality clinical trials in children and young people.

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population.

Challenges in clinical trials for children and young people.

There is a well-known knowledge gap regarding the efficacy and safety of medicines in children of all ages and children are often treated with medicines off-label. Children are thus deprived of treatment based on the same quality of information that guides treatment in adults. The knowledge gap regarding efficacy and safety of medicines in children has been acknowledged by authorities and is reflected in legislation both in North America and in the European Union.

Can clinical and urodynamic parameters predict the occurrence of neutralizing antibodies in therapy failure of intradetrusor onabotulinumtoxin A injections in patients with spinal cord injury?

Background: The aim of the study was to clarify whether clinical and/or urodynamic parameters could be used to infer the probability of neutralizing antibody (NAb) formation as a possible cause of therapy failure (non-response, NR) in patients with neurogenic detrusor overactivity (NDO) due to acquired spinal cord injury/disease (SCI/D) treated with intradetrusor botulinum neurotoxin A (BoNT-A) injections.

Methods: A retrospective chart review was performed of all patients with SCI/D who underwent both intradetrusor onabotulinumtoxin A injections and the determination of neutralizing antibodies against BoNT-A between January 1, 2002, and December 31, 2018. NR was defined as urodynamically confirmed persistent or reappearing NDO.

Incidental bladder cancer at initial urological workup of spinal cord injury patients.

Study Design: Retrospective descriptive study.

Objectives: To compare histopathological findings and the long-term course of SCI patients with bladder cancer found incidentally at the initial urological workup to those diagnosed with bladder cancer many years after the onset of SCI.

Setting: Spinal cord injury center in Germany.

The Real Daily Need for Incontinence Aids and Appliances in Patients with Neurogenic Bladder Dysfunction in a Community Setting in Germany.

Purpose: For successful long-term rehabilitation of patients with neurogenic lower urinary tract dysfunction (NLUTD), it is necessary to define the objective requirement for urological aids based on a scientifically validated basis.

Methods: This was a cross-sectional multicenter study, based on a questionnaire. Data concerning bladder management and daily consumption of urological appliances for patients with NLUTD in a community setting were collected through a standardized survey.

[Urinary bladder cancer as a late sequela of spinal cord injury : Decision-making aids for assessment of this causal association].

Background: There is to date no convincing literature that has assessed the association between traumatic spinal cord injury (SCI) and the later development of urinary bladder cancer. The aim of this work is to present medical experts as well as the national accident insurance and the social courts decision-making aids based on the latest medical scientific knowledge, for assessment of this causal association.

Materials And Methods: A study conducted between April 1998 and March 2017 in the BG Trauma Hospital Hamburg forms the basis for the decision-making aids.

Traumatic spinal cord injury confers bladder cancer risk to patients managed without permanent urinary catheterization: lessons from a comparison of clinical data with the national database.

Purpose: Life expectancy for people with traumatic spinal cord injury (SCI) is increasing due to advances in treatment methods and in neuro-urology. Thus, developing urinary bladder cancer (UBC) is gaining importance.

Methods: Single-centre retrospective evaluation of consecutive in- and out-patient data with spinal cord injury between January 1st, 1998 and December 31st, 2018 was carried out and data were compared with UBC data of the German population from the German Centre for Cancer Registry Data at Robert Koch Institute.

What Could the Future of Safety Monitoring Look Like?

Like much of the clinical research and health care provider enterprise, the data capture and archiving for harm, probability of harm, and impact of intervention-related events is fragmented, inconsistent, and lacks standards to perform the types of operations that could inform researchers, practitioners, and patients in a timely way of actions and policies. The entire system of assessments, terminology, data formats and structure, analyses, and dissemination would benefit from changes based on adherence to a process framework of detect, describe, analyze, and react in the context of recognizing the multiple pathways and factors that lead to any specific outcome or series of outcomes. Existing tools, if properly applied, can form the basis for the next generation of data systems, processes, analyses, and sharing to address most of the current challenges.

Weight estimation among multi-racial/ethnic infants and children aged 0-5·9 years in the USA: simple tools for a critical measure.

Objective: In resource-constrained facilities or during resuscitation, immediate paediatric weight estimation remains a fundamental challenge. We aimed to develop and validate weight estimation models based on ulna length and forearm width and circumference measured by simple and portable tools; and to compare them against previous methods (advanced paediatric life support (APLS), Theron and Traub-Johnson formulas).

Design: Cross-sectional analysis of anthropometric measurements.