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Delirium is a critical and complex neuropsychiatric syndrome that significantly affects older adults in general hospital wards. Although multicomponent interventions have been shown to be effective in preventing delirium, the consistent implementation remains a challenge. Also, to manage the complex pathway of patients from admission to discharge in hospital, the involvement of the nursing staff is essential. Developing a nurse-led clinical pathway for delirium prevention could provide a structured approach to improving care quality. For intervention development taking account of the complexity of the clinical environment, the UK Medical Research Council framework is frequently used. A core element of this framework is mapping a programme theory that explains how, for whom and in what circumstances an intervention may work. The realist review methodology is well suited to uncovering the underlying mechanisms, contexts and outcomes of interventions, translating these into a programme theory.
The aim of this realist review is to develop a programme theory for a nurse-led clinical pathway to prevent delirium in older adults aged 65 years or older in general hospital wards and to identify strategies to support its effective implementation.
The realist review is based on the methodical framework developed by Pawson et al and further adapted by Rycroft-Malone et al and the reporting will follow the Realist And MEta-narrative Evidence Syntheses: Evolving Standards guidelines. The process comprises four steps: (1) defining the review scope; (2) systematically searching for and appraising the evidence; (3) extracting and synthesising findings and (4) developing a narrative synthesis. Interest holders, including clinical and academic experts, will be actively involved as an expert reference group to inform and refine the programme theory. The final programme theory will be presented in Context-Mechanism-Outcome configurations and the Implementation Research Logic Model.
Since no data are collected as part of the review, ethical approval is not required. Findings will be disseminated through academic conferences and publication in a peer-reviewed journal.
This protocol has been registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/7EPTF).
To explore perceptions of digitalisation and patient safety from the view of the German general public and related sociodemographic factors.
Cross-sectional survey.
A nationwide survey was undertaken in 2024, using data from the Techniker Krankenkasse (TK) Monitor of Patient Safety. The TK Monitor of Patient Safety is an annual survey of the population on the state of patient safety in medical care.
1000 German adults (18 years and older).
Ordinal logistic regression analyses were performed to investigate the associations among sociodemographic factors (age, gender, education and household income) and perceptions on digitalisation and patient safety.
The majority of respondents expected benefits from digital applications in healthcare. Over half of the respondents (58%) believed that artificial intelligence (AI) can help reduce complications and errors, while 49% of the respondents believed that the use of AI poses serious new risks for the healthcare sector. The results showed that sociodemographic variables are important factors influencing patient safety perceptions of digitalisation and AI. Female, older, less educated and/or lower-income individuals were less likely to perceive benefits from digital care applications and AI.
In our study, the German public appears to view digital technologies and AI as tools both for improving patient safety and as potential risk factors. Our findings also highlight the importance of analysing sociodemographic factors to identify specific disparities in how different groups are affected by digitalisation. Such analysis is essential for developing targeted strategies that mitigate current patient safety risks, ensuring that digital health solutions are equitable and safe across all demographic groups.
Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with Ureaplasma species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, Ureaplasma exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on Ureaplasma-associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with Ureaplasma in very immature preterm infants born Ureaplasma colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.
This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for Ureaplasma colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.
The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.
German Clinical Trials Register (DRKS00033001).
Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.
The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t0), the first, third and sixth treatment sessions (t1, t3, t6) and at 3 months follow-up (t7). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.
The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.
DRKS00031694.
Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.
This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.
This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.
The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.
The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.
Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.
Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.
Suicidal thoughts and behaviours are linked to a wide range of mental health conditions. New interest in the psychiatric benefits of nitrous oxide (N2O) has only recently emerged. The broad pharmacological effects of N2O are thought to be due in large part to N-methyl-d-aspartate antagonism and opioid effects. The purpose of this study protocol is to test whether inhalational N2O exerts rapid antisuicidal effects as a transdiagnostic treatment for suicidal ideation.
This is the protocol of a single-centre pilot study of N2O inhalation in 85 psychiatric inpatients. The initial 45-min double-blind, randomised, placebo-controlled inhalation session either consists of 50% N2O and 50% oxygen (‘active treatment’) or 50% oxygen plus air. The primary outcome is the change in Beck Scale for Suicidal Ideation scores between the day before and the day after inhalation. A second inhalation containing N2O will be administered 1 week after the first inhalation to ensure that all study participants receive the active treatment at least once. For the mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques, including analysis of hair and blood samples and electroencephalography.
This study was approved by the local ethics committee (‘Kantonale Ethikkommission—Kanton Zürich’) and by the Swiss Agency for Therapeutic Products (Swissmedic). Study results will be disseminated primarily by peer-reviewed scientific journals and also by conference presentations, patient and public events and social media.
ClinicalTrials.gov ID NCT06636357.
Persistently low serum alkaline phosphatase (ALP) activity is the hallmark of hypophosphatasia (HPP). However, low ALP values are not commonly recognised in routine clinical practice, often leading to delayed HPP diagnosis. Determining symptoms associated with persistently low ALP activity may facilitate a timelier diagnosis and improved treatment of patients with HPP. This study aimed to evaluate the signs and symptoms associated with low ALP.
Retrospective, multicentre, cross-sectional study.
Medical records of adults with low ALP activity collected in 18 German clinics and large medical centres with medical specialty in endocrinology, diabetology, rheumatology and osteology were assessed. Serum ALP activity, medical history, previous diagnoses, laboratory values and symptoms were analysed.
Records were screened to identify patients≥18 years with ALP activity below the lower limit of the normal range within the last 5 years. Exclusion criteria were oncological or haematological disorders, intensive care at the time of low ALP measurement and having more than one ALP measurement in the normal range or above. Data from 849 patients with ≥1 low ALP value (median age: 44.0, min 18.0, max 90.0), including a subset of 32 patients with documented HPP diagnosis, were analysed.
The study cohort presented with a spectrum of clinical manifestations and diagnostic profiles. Patients with HPP displayed typical symptoms, in particular musculoskeletal pain and fractures, more often than patients without HPP diagnosis (n=817). Among patients without HPP, 26.6% were diagnosed with hypothyroidism. 35 patients displayed 4+ clinical and biochemical signs typical for HPP that were attributed to differential diagnoses, such as rheumatic diseases, fibromyalgia and osteoporosis/osteopenia, suggesting the possibility of underlying HPP in some cases.
Most patients in this study had hypophosphatasemia without further evaluation, highlighting the need for greater awareness of low ALP levels in clinical practice. Recognising low ALP levels, especially when accompanied by symptoms like pain, musculoskeletal and dental abnormalities, is crucial for timely diagnosis and improved patient care.
Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.
To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.
The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.
The trial was approved by the Charité—Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.
The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).
Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.
A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.
This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.
New-onset supraventricular arrhythmia (NOSVA) is the most common arrhythmia in patients with septic shock and is associated with haemodynamic alterations and increased mortality rates. With no data available from randomised trials, clinical practice for patient management varies widely. In this setting, rate control or rhythm control could be beneficial in limiting the duration of shock and preventing evolution to multiorgan dysfunction.
The Control Atrial Fibrillation in Septic shock (CAFS) study is a binational (French and Belgium), multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three management strategies in patients with NOSVA during septic shock. The expected duration of patient enrolment is 42 months, starting from November 2021. Patients will be randomised to receive either risk control (magnesium and control of risk factors for NOSVA), rate control (risk control and low dose of amiodarone) or rhythm control (risk control and cardioversion using high dose of amiodarone with external electrical shock if NOSVA persists) for 7 days. Patients with a history of SVA, NOSVA lasting more than 48 hours, recent cardiac surgery or a contraindication to amiodarone will not be included. We plan to recruit 240 patients. Patients will be randomised on a 1:1:1 basis and stratified by centre. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality and the duration of septic shock defined as time from randomisation to successful weaning of vasopressors. Secondary outcomes include: individual components of the primary endpoint; arterial lactate clearance at day 3; efficacy at controlling cardiac rhythm at day 7; proportion of patients free from organ dysfunction at day 7; ventricular arrhythmia, conduction disorders, thrombotic events, major bleeding events and acute hepatitis related to amiodarone at day 28; intensive care unit and hospital lengths of stay at day 28.
The study has been approved by the French (Comité Sud-Ouest et Outre-Mer II, France, registration number 2019-A02624-53) and Belgian (Comité éthique de l’hôpital Erasme, Belgium, registration number CCB B4062023000179) ethics committees. Patients will be included after obtaining signed informed consent. The results will be submitted for publication in peer-reviewed journals.
FreshRSS 