Research for pandemic response needs to be timely to inform evidence-based decision making. The lack of epidemiological data at the start of the COVID-19 pandemic led experts to call for cohorts that could rapidly supply data about newly emerging infectious diseases. The ‘Bern, get ready’ (BEready) study aims to establish a prospective ‘pandemic preparedness cohort’ in the canton of Bern, Switzerland. This cohort can be pivoted to the needs of a new pandemic pathogen. The aim of this pilot study was to investigate the potential response and to test the feasibility of procedures for BEready.

Closed population-based cohort study.

Random sample of private households in the canton of Bern, Switzerland, that had previously responded to an online survey.

Adults, children and pets.

Enrolment as a percentage, associations between the agreement to participate and the demographic and socioeconomic variables of the invited household member, number of social contacts, proportion of samples collected, proportion of complete questionnaires and proportion of participants responding after 12 months.

After the initial in-person visit with venous blood sampling, participants were followed up for 1 year. We tested remote data collection methods, with online questionnaires and self-collected capillary blood and nasopharyngeal samples, and established a biobank.

The pilot study enrolled 106/1138 (9%) of invited households plus two additional households that had proactively contacted us. In total, we enrolled 193 people in 108 households (1.8 per household) and 44 pets between April and September 2023. We obtained and stored at least one venous and/or capillary baseline blood sample from 184/193 (95%) people and 40/44 (91%) pets. After 1 year, 172/193 (89%) people in 101/108 (94%) of households completed a follow-up survey, as did 22 owners of 34/44 (77%) pets. 151/172 (88%) respondents returned a follow-up capillary blood sample.

The response rate to the pilot study shows that obtaining high levels of participant enrolment in a pandemic preparedness cohort study is challenging. Data collection without face-to-face contact with a study team is feasible for household members and will be needed in BEready if control measures during a pandemic prevent in-person studies.

Despite the growing volume of research in surgical education (SurgED), the integration of evidence into teaching practice remains fragmented and inconsistent. A structured and continuously updated synthesis is needed to support data-informed curriculum development and promote best practices across training programmes.

This protocol describes the development of a living systematic review and evidence map of SurgED research. Studies will be identified through comprehensive searches of CENTRAL, PubMed and Web of Science, and screened independently by two reviewers, supported by an Artificial Intelligence (AI)-assisted screening tool to improve efficiency. Eligible studies will include both quantitative and qualitative designs involving medical students, surgical residents and faculty. Studies will be categorised across key educational domains such as simulation-based training, competency-based assessment, feedback, mentoring and technology-enhanced learning. The evidence map will be updated at least quarterly, with new studies screened and added in near real-time to ensure that the map remains current and actionable.

As this study does not involve human participants, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, presentations at national and international conferences and open access integration into the Evidence at a glance (EVIglance) evidence platform.

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.