Prolonged weaning from invasive mechanical ventilation is a major challenge in critically ill patients failing a spontaneous breathing trial. Levosimendan, a calcium sensitiser, has been shown to improve respiratory muscle function. However, its effect on clinically relevant endpoints in difficult to wean patients has not yet been investigated. We aim to assess whether levosimendan shortens the weaning process in invasively ventilated intensive care unit (ICU) patients who fail a separation attempt. The objective is to assess the effect of levosimendan on the number of ventilator-free days and alive at day 28.

The WEANing with LEvoSimendan Study (WEANLESS) is an investigator-initiated, multicentre, double-blind, parallel-group, randomised clinical superiority trial. Adult invasively ventilated patients who failed a separation attempt are randomly assigned to receive either intravenous levosimendan (intervention) or placebo (control). The primary outcome is the number of ventilator-free days and alive at day 28 from randomisation. WEANLESS also evaluates the effects of levosimendan on patient-reported outcomes, measured through daily dyspnoea scores and uses an EQ-5D-5L questionnaire. Additionally, we will evaluate healthcare resource utilisation and intensive care capacity, assessed through reintubation rates, ICU readmissions within 90 days, the need for non-invasive respiratory support and ICU length of stay. WEANLESS includes a pharmacokinetic analysis of levosimendan and its metabolites.

WEANLESS is the first clinical study that is sufficiently powered to determine the effect of intravenous levosimendan in difficult to wean patients on the duration of weaning from invasive ventilation.

WEANLESS is registered before the inclusion of the first patient at clinicaltrials.gov; the study protocol has been approved by the relevant ethics committee. Its findings will be disseminated through presentations at scientific conferences and publications in a peer-reviewed journal.

NCT07105202.

Sepsis is a global health priority with nearly 50 million cases annually. Cardiovascular dysfunction is common, frequently manifesting as hypotension that persists despite fluid resuscitation. Most affected patients require the use of intravenous (IV) vasoactive agents, typically necessitating intensive care unit (ICU)-level monitoring, invasive interventions and contributing substantially to healthcare costs. Midodrine, an oral alpha-1 agonist approved for orthostatic hypotension, has increasingly been used off-label as a vasopressor-sparing (reducing IV vasopressor use) strategy in sepsis, despite limited and inconsistent evidence. This pragmatic, randomised, open-label trial evaluates the efficacy and safety of midodrine in patients with sepsis-associated hypotension. We hypothesise that, compared with standard care, midodrine administration will reduce the duration of IV vasopressor use.

A total of 308 adult patients with sepsis-associated hypotension will be enrolled (154 per arm). The intervention group will, in addition to standard of care, receive enteral midodrine 10 mg three times daily. Outcomes will be ascertained pragmatically via electronic health record-based data retrieval and adjudicated by research coordinators blinded to treatment assignment. The primary outcome is time alive and off IV vasopressors in the first 28 days (in hours) after randomisation. Secondary outcomes include cumulative vasopressor exposure; use and duration of central venous access; cumulative fluid balance over the first 48 hours and up to 7 days of ICU stay; ICU and hospital length of stay; and ICU-, hospital-, and organ support-free days through day 28. Safety outcomes include adverse events potentially attributable to midodrine during hospitalisation including acute kidney injury. Primary analyses will follow an intention-to-treat framework, including all randomised participants according to their assigned treatment groups. Primary and secondary outcomes will be compared using a van Elteren test stratified by randomisation factors. A predefined secondary Bayesian analysis of the primary outcome will provide complementary estimates of treatment effect. Safety outcomes will be summarised descriptively without formal between-arm hypothesis testing.

The Mayo Clinic Institutional Review Board approved this protocol and required written informed consent from all participants (IRB# 24–0 00 121). Findings will be disseminated through peer-reviewed publications and international conference presentations.

NCT06319248.

Suicidal thoughts and behaviours (STB) are a critical public health concern, with 700 000 deaths by suicide each year. The period immediately following hospital discharge is associated with an elevated risk for suicide. Monitoring suicidal ideations throughout this period is therefore critical. However, its highly dynamic nature limits the utility of traditional risk assessments through infrequent outpatient visits. Recent advancements in ambulatory assessments and multimodal predictive approaches offer a promising new avenue. Hence, the present study aims to examine how psychological, linguistic, neurobiological and smartphone-based characteristics relate to suicidal ideation and to improve STB monitoring through a deep phenotyping approach.

In this interdisciplinary, multicentre, prospective observational study, we plan to recruit a total of 200 inpatients with current and/or past STB. The study comprises the following components: (1) a baseline assessment, conducted while participants are still in the hospital. This includes interviews, an electroencephalography recording, a video-recorded verbal task and self-report questionnaires; (2) data collection through a smartphone application during the first 4 weeks after hospital discharge with two active collection weeks of five daily ecological momentary assessments and two 1 min video diaries every other day, as well as smartphone passive sensing for 28 consecutive days and (3) two follow-up assessments, 4 weeks and 3 months after discharge. The primary outcome is self-reported suicidal ideation after hospital discharge.

The Ethics Committee of the Faculty of Arts and Social Sciences of the University of Zurich, Switzerland, approved the study for the Zurich and Basel sites (Ref: 22.09.19). Approval for the New York Site was granted by the Institutional Review Board of NYU Langone Health (i23-00366). Study findings will be disseminated via peer-reviewed, open-access publications, conference presentations, patient and public events, and dedicated social media outlets.

CRSII5_205913.

Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.

Cross-sectional, retrospective.

Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.

The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.

87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p

Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.

NCT01538550.

To synthesise the perspectives of healthcare professionals and patients/residents of hospitals/nursing homes about determinants of inappropriate indwelling urinary catheter (IUC) use and strategies for reduction.

Qualitative evidence synthesis.

We searched MEDLINE, Scopus and CINAHL for studies published between 1 January 2000 and 23 May 2025.

Studies were eligible if they used qualitative methods to explore the perceptions and experiences of healthcare professionals and patients/residents of hospitals/nursing homes or their family members regarding the determinants of IUC use and reduction. Included studies focused on behavioural drivers or strategies to reduce inappropriate IUC use.

Two independent authors reviewed the search results, extracted and coded data, and assessed methodological strengths and limitations of studies. We used a thematic synthesis approach following the Cochrane–Campbell Handbook for Qualitative Evidence Synthesis and applied the Grading of Recommendations Assessment, Development and Evaluation–Confidence in the Evidence from Reviews of Qualitative Research approach to assess confidence in the findings.

We synthesised 24 studies. Perceived determinants of inappropriate IUC use included non-adherence to guidelines due to vague indications for initial IUC insertion, differing perspectives on benefits and risks, low priority given to the topic, limited accessibility or perceived unsuitability of alternatives, high nurse workload and staff shortages (moderate confidence). Ineffective nurse–physician communication, documentation difficulties and lack of training were also assumed to be linked to inappropriate IUC use (low confidence). Mentioned strategies for the reduction of inappropriate IUC use included additional training for healthcare professionals, clinician reminders to review or remove catheters, improved electronic documentation systems, increased staffing and greater use of IUC alternatives.

Key drivers of inappropriate IUC use are vague indications and routine decisions, lack of suitable and available alternatives, staff shortages and perceived lack of importance of the topic. Addressing these barriers is important for deimplementing inappropriate IUC use, and multifaceted strategies appear to be the most promising approach to address the multiple factors that drive current IUC misuse.

CRD42024531522.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).

First, to understand social needs in different mental disorders. Second, to determine patterns of social behaviour for either physical and online encounters in patients with depression.

Sequential qualitative design: (1) exploratory qualitative interview study investigating social needs of mentally disordered patients, followed by (2) qualitative network analysis of patients and healthy controls, analysed using inductive coding and triangulation for data aggregation and network visualisation. Standards for Reporting Qualitative Research (SRQR) were followed.

(1) Professionals from inpatient and outpatient mental health services of psychosomatic medicine, psychotherapy and psychiatry. (2) Patients from outpatient services, healthy controls from various settings.

(1) Nine mental health professionals with seven physicians and two psychological psychotherapists took part in interviews. (2) Network interviews were conducted with 10 patients with a diagnosis of depression given within the past year and nine healthy controls with matching sociodemographic characteristics.

Social relationships influence both the illness history and symptom profile of patients with depression. Patients reported less encounters compared with controls, although the frequency of their encounters was higher. Patients reported positive and trustful, yet more ambivalent relationships. Patients perceived less trust, but more influence on personal well-being by their encounters. Online contacts were described as more superficial by both groups.

Qualitative network analysis reveals patterns of social needs in physical and online encounters and their visualisation allows for direct group comparisons. Biopsychosocial research designs with a larger sample size are recommended. Targeted interventions have to regard the complexity of relationship patterns in physical and online interactions.

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

DRKS00034899.

V2.1, 6 June 2024.