To determine the prevalence and clinical characteristics associated with polyneuropathy in kidney transplant recipients (KTRs).

Cross-sectional study.

SENS study at the University Medical Center Groningen, the Netherlands, December 2021–May 2023.

KTR, participating in the ongoing TransplantLines Biobank and Cohort Study, ≥12 months post-transplantation.

Participants underwent a structured neurological assessment including history taking, neurological examination, quantitative sensory testing and nerve conduction studies. An expert panel classified participants into no/possible, probable/definite large fibre polyneuropathy or small fibre neuropathy. Large-fibre subtypes included axonal or demyelinating, pure sensory, pure motor and sensorimotor. To assess potential associations with clinical characteristics, logistic regression analysis was conducted.

We included 160 KTRs with a mean age of 59.8±11.6 years at a median of 6.1 (95% CI 3.9 to 13.1) years post-transplantation, with 16 KTRs (10%) diagnosed with polyneuropathy before study inclusion. In total, 84 KTRs (53%) were identified with large fibre polyneuropathy and 7 KTRs (4%) with small fibre neuropathy. KTRs with large fibre polyneuropathy presented with either sensor-predominant polyneuropathy (40 KTR (48%)) or sensorimotor polyneuropathy (44 KTR (52%)). We found no neurophysiological characteristics of demyelination. Overall, 18% (95% CI 11% to 27%) of KTRs with large fibre polyneuropathy were asymptomatic. Higher age (OR=1.04 (1.01 to 1.08), p=0.01), male sex (OR=2.55 (1.19 to 5.60), p=0.02), diabetes (OR=5.58 (1.36 to 38.14), p=0.03) and elevated urea levels (OR=1.12 (1.04 to 1.23), p=0.01) were significantly associated with polyneuropathy in KTR.

In contrast with previous studies, axonal sensory or sensorimotor polyneuropathy is highly prevalent and often underdiagnosed in KTR. Next to higher age and male sex, it was independently associated with diabetes and higher urea levels. Further research is needed to reveal the aetiology and course of polyneuropathy in KTRs.

NCT04664426.

The BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) study is a multicentre prospective observational cohort designed to identify biomarkers associated with prostate cancer (PCa) risk that may be modifiable through lifestyle factors. This paper describes the cohort, along with the data and bio-samples available for future studies in PCa risk assessment.

Canadian men at risk of PCa were enrolled based on one of two criteria (1) negative first prostate biopsy within 6 months from enrolment (Group 1); or (2) a prostate-specific antigen (PSA) blood level between 2.5 and 10 ng/mL without prior prostate biopsy (Group 2). At baseline, blood samples and comprehensive data were collected. PCa incidence and lifestyle factors were updated for all participants over 2 years, with extended follow-up for those who provided additional consent.

Recruitment was conducted across four health centres in Quebec, Canada. A total of 2053 men were enrolled—1499 in Group 1 and 554 in Group 2. All participants completed the initial visit, which included collection of medical and family history, anthropometric measurements, demographic information, dietary and alcohol intake, physical activity, tobacco use, medication use, and quality of life assessments, and candidate biomarker measurements. At the 2-year mark, 7.2% of participants had developed PCa; this figure has since increased to 15.3% (median follow-up: 6.1 years). Additionally, 84% (n=1718) consented to ongoing annual follow-up.

This large, prospective cohort of men at risk of PCa offers valuable resources for risk stratification and primary prevention. The BioCaPPE biosamples and data are available to support the identification of lifestyle-related biomarkers associated with PCa risk in this population.

ClinicalTrials.gov Identifier: NCT03383016.

Spinal cord injury (SCI) impairs autonomic functions, which are ranked among the highest priorities for recovery. The loss of autonomic control, including bowel, bladder, sexual and cardiovascular functions, interferes with rehabilitation and decreases health-related quality of life (HRQoL). Preliminary evidence indicates that non-invasive transcutaneous spinal cord stimulation (TCSCS) has the potential to improve autonomic stability in people with SCI. However, the optimal stimulation site for improving autonomic responses remains to be determined. This pilot randomised clinical trial aims to explore the efficacy of non-invasive mid-thoracic and lumbosacral TCSCS (proof-of-concept) for blood pressure stability (orthostatic hypotension and autonomic dysreflexia burden) alongside end-organ autonomic functions (lower urinary tract, bowel and sexual function) and HRQoL.

30 participants with chronic (>1 year) motor-complete SCI (American Spinal Injuries Association Impairment Scale A and B) at or above T6 will be enrolled in this open-label, two-arm randomised pilot clinical trial. Participants will be block randomised into either the mid-thoracic or lumbosacral TCSCS group. Participants will then undergo 8 weeks of TCSCS (3 times per week for 60 min; 24 sessions total) while in a seated position. Post-treatment effects will be recorded following the 8-week intervention and follow-up effects will be recorded 8 weeks after the end of the intervention. Primary and secondary outcomes will assess resting blood pressure, autonomic dysreflexia, orthostatic hypotension and lower urinary tract, bowel and sexual functions as well as HRQoL.

This study is approved by The University of British Columbia’s Clinical Research Ethics Board (UBC CREB H22-00365), and by Health Canada for Investigational Testing Authorisations (ITA) for Class II medical devices used in this trial (ITA#346875 TESCoN; ITA#381 154 SCONE). The findings will be disseminated through peer-reviewed publications, conferences, seminars and SCI community outreach.

NCT05369520.

The literature on sustainability performance frameworks for healthcare organisations varies in its applicability to different types of organisations and settings, functions and activities, and definitions and dimensions of sustainability. This fragmentation creates implementation barriers which may be overcome by consolidating existing evidence in a format that can be linked directly to organisations’ business models. This protocol proposes a scoping review to assess the extent of the literature on frameworks for monitoring and evaluating the multidimensional sustainability performance of healthcare organisations and to assemble a consolidated framework in an operationally relevant format to support progress towards sustainable healthcare organisations.

The search strategy will be applied across Semantic Scholar, Google Scholar, Web of Science, MEDLINE, Embase, Academic Search Premier, CINAHL and Business Source Premier databases. Search results from 2009, coinciding with the publication of the WHO’s ‘Healthy Hospitals, Healthy Planet, Healthy People’ report, will be considered. The scoping review will include studies reporting on multidimensional sustainability monitoring or evaluation frameworks applied or developed for use at the level of healthcare delivery organisations. Studies relating to operational units within organisations or to healthcare systems will be excluded. The review’s context will be restricted to operational sustainability and will not consider the literature on sustainable design planning and construction of new facilities. No specific exclusion criteria will be applied to the types of healthcare delivery organisations nor participants implicated in the frameworks. Title and abstract screening against the inclusion and exclusion criteria, followed by full-text assessment of remaining articles, will be performed by two reviewers. Data from included studies will be extracted using a custom-designed extraction tool, analysed using topic or thematic analysis to consolidate themes and presented within the triple-layered business model canvas.

Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.

To evaluate the feasibility and relevance of the LIFE-UP Day audit, a simple, 1-day benchmarking tool based on the multidisciplinary LIFE-UP bundle (Limit sedation, optimise nutritional Intakes, engage Families, promote Exercise and follow-UP the patients after discharge) and assessing the implementation of postintensive care syndrome (PICS) prevention strategies in daily practice.

Exploratory multicentre cross-sectional audit study.

Eight Belgian adult intensive care units (ICUs), between April and July 2024.

All patients present at 08:00 on the audit day and hospitalised for ≥24 hours.

An independent nurse collected data on sedation, analgesia, nutrition, family empowerment, physical exercise and post-ICU follow-up. A multidimensional LIFE-UP composite score (raw 0–10 points), normalised to a 5-point scale, was created to quantify adherence to PICS prevention practices based on current recommendations. Feasibility was evaluated through data accessibility, resource needs, cooperation of ICU teams and the ability to complete the audit within 1 day. Relevance was evaluated through adherence to the bundle, assessed by comparing LIFE-UP scores between ICUs. Quantitative results were expressed as median and IQR.

The audit was tested in 87 patients aged 68 (59–74) years, 9 (5–15.5) days after their admission. The audit was feasible across all ICUs: necessary data were available, resources required were minimal and cooperation was excellent. The LIFE-UP score highlighted significant variability between ICUs (2.5 (1.75–2.75), p

The LIFE-UP Day audit proved feasible and provides a first structured framework for benchmarking. Broader implementation will be essential to validate the LIFE-UP score, refine the model and ultimately determine whether it can translate into improved patient and family outcomes.

Cadmium is a metal that poses significant health risks, particularly in occupational environments where exposure can happen. The main objective of this scoping review is to review the cadmium exposure levels in the different occupational settings in the European Union (EU), considering the regulatory measures currently in place. The secondary objectives, depending on the availability of data, are (a) to identify the occupational settings where higher exposure levels occur, (b) to identify any geographical and temporal differences and trends within the EU and (c) to identify the most relevant co-exposures reported.

A scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews reporting guidelines. Studies reporting quantitative occupational data on cadmium exposure obtained through human biomonitoring and/or air monitoring will be included. A descriptive analysis of the findings will be performed.

This protocol for a scoping review does not require ethical approval as it is based on secondary data. The dissemination plan of the scoping review includes its publication in a scientific journal of reference, as it is expected that it will provide important knowledge to support ongoing and future occupational health interventions in the EU, at the technical and regulatory levels.

This study is registered at the Open Science Framework (OSF), 7 April osf.f2w3h.

People with longstanding hip and groin pain (LHGP) are often referred to orthopaedic care. Physical therapist-led interventions are recommended in consensus statements as the first line of treatment, but it is unknown if structured interventions are more effective than usual care. The aim of this trial is to evaluate the effectiveness of a structured physical therapist-led treatment model (HIPSTER) compared with usual care on hip-related quality of life at 4 months for people with LHGP referred to orthopaedic care.

This is a preregistered (clinicaltrials.gov, NCT05853640) study protocol for a double-blinded two-armed pragmatic randomised controlled trial. Patients with LHGP (n=122), referred to the Department of Orthopaedics at a university hospital in Sweden, will be randomised into the HIPSTER model or usual care. The HIPSTER model is a 16-week structured, individualised progressive treatment using exercise therapy and patient education. Usual care consists of a recommendation to contact a physical therapist in primary care. Both groups will undergo standard examinations and a surgical consultation at the Department of Orthopaedics. The primary outcome will be the mean group change in the International Hip Outcome Tool from baseline to 4 months, according to intention-to-treat principles. Secondary outcomes include patient-reported outcomes (such as perceived improvement, psychological factors and physical activity), physical impairment tests and radiographic measures. Additional time points will be 1, 2 and 5 years after baseline. Subgroups of patients will complete semistructured interviews and report additional data on psychosocial variables to provide more information on patient experience as well as determinants of adherence.

The Swedish Ethical Review Authority approved this study (Dnr 202205023–01). The results of this study will be published, regardless of results, in scientific journals and as plain language summaries for participants.

NCT05853640.

Carpal tunnel syndrome (CTS) has become one of the most prevalent occupational health problems1 and represents a major burden for individuals, employers1 2 and healthcare systems.1 The need to consider psychosocial factors such as stress and coping strategies is increasingly recognised...

Respiratory syncytial virus (RSV) is a leading cause of hospitalisation in infants worldwide. New immunoprophylactic products, including long-acting monoclonal antibodies and maternal vaccines, have demonstrated high efficacy in prelicensure clinical trials. Understanding how these interventions perform outside controlled trials, and how viral evolution or host factors influence protection, is essential for sustaining confidence in RSV prevention programmes.

We will conduct a 5-year, test-negative case–control study among infants ≤12 months of age who present with acute respiratory illness (ARI) within a large healthcare delivery network serving a demographically diverse population. Cases will be infants testing positive for RSV by PCR, and controls will be RSV-negative infants meeting the same ARI criteria. Data will be obtained from electronic health records, structured caregiver surveys and state immunization registries to ensure accurate classification of exposures and covariates. Vaccine effectiveness will be estimated using multivariable logistic regression controlling for potential confounding. RSV-positive specimens will undergo full-genome sequencing to identify variant lineages and potential immune-escape mutations. A subset of participants will provide acute and convalescent blood samples for single-cell immune profiling to define innate and adaptive responses associated with breakthrough infection.

The study protocol has been approved by the Yale Human Investigation Committee (HIC #2000036550). Written informed consent will be obtained from all parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications, scientific meetings and public repositories, with fully de-identified participant data to protect privacy and confidentiality. Viral genomic data will be shared in accordance with the National Institutes of Health Genomic Data Sharing Policy, and analytical code will be made publicly available to ensure reproducibility.

NCT06172660.

Dyspnoea is an existentially burdensome symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure. Recent studies have highlighted that symptomatic treatment of dyspnoea is often ineffective and may depend on the underlying disease. Immersive virtual reality (IVR) has emerged as a ‘digital therapeutic’ for conditions such as pain, anxiety, and dyspnoea. Brain functional MRI (fMRI) offers the opportunity to identify distinct patterns of dyspnoea. Current findings are mainly limited to healthy volunteers, but clinical data from patients with life-limiting conditions are needed. The aim of this study is to assess the feasibility of identifying dyspnoea patterns in different life-limiting conditions using fMRI and IVR.

This is an observational monocentric feasibility study, conducted in a tertiary university centre. Healthy volunteers and patients diagnosed with advanced cancer, COPD, or heart failure and suffering from persistent dyspnoea will undergo an fMRI of the brain using IVR. The primary outcome of feasibility will be evaluated using descriptive statistics. Secondary outcomes include analysis of fMRI patterns of dyspnoea across populations, patient-reported burden of participation, and correlation between dyspnoea and psychological symptoms. These preliminary data will help determine the sample size required for a future study evaluating differences in dyspnoea patterns. Exploratory comparison between the characteristics of all four groups will be assessed with Fisher’s test (for proportions) and either independent Student’s t-test or Mann-Whitney test, depending on distribution. Correlations between variables will be tested using the Pearson’s correlation coefficient. Statistical analysis will be performed using STATA.

This study protocol received ethical approval on 23 April 2025 from the Commission cantonale d’éthique de la recherche in the Canton of Geneva, Switzerland. The identification number is 2024-02289. Submission to peer-reviewed journals and presentation in international congresses for the dissemination of the study findings are planned.

Clinical Trials number is NCT07319039; Pre-results.

Healthcare logistics involves the coordination of resources, services and infrastructure to ensure timely and efficient care delivery. Process mining offers data-driven insights into logistical workflows such as patient transport, inventory management and scheduling. This systematic review aims to synthesise evidence on the application of process mining in healthcare logistics, focusing on its impact on operational efficiency, resource utilisation and service delivery.

A systematic search will be conducted in MEDLINE, Embase, Google Scholar, Web of Science and ABI/Inform for studies published from 1999 onward. Eligible studies will include observational studies, case reports, conference papers and meta-analyses focusing on process mining applications to logistical processes in healthcare settings. Studies screening, data extraction and methodological quality assessment will be conducted using the Mixed Methods Appraisal Tool. Data will be extracted on key dimensions and performance indicators and will be presented in a structured format. A narrative synthesis will be conducted, and findings will be categorised and thematically analysed where appropriate. Primary outcomes include improvements in logistical efficiency, traceability, resource utilisation and sustainability. Secondary outcomes include implementation challenges, data integration issues and limitations in applying process mining techniques to logistical workflows.

The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. The data we will use do not include individual patient data, so ethical approval is not required.

CRD420251164812.

To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

NCT03387423.

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

DRKS00030749 (29-09-2023)

Night shift work is well known to cause health disruption in the short and long term. Among healthcare workers, sleep deprivation is a common concern with many nurses reporting sleep of

A 12-week randomised controlled trial will be performed with two conditions: (1) a 30 min nap opportunity during night shift work in a dedicated quiet room with a bed and (2) a control condition including a 30 min rest period in a break room. A total of 80 nurses and assistant nurses from interventional care units working a 2x12 hour shift schedule will be recruited. The main outcome will be endothelial dysfunction assessed through the reactive hyperaemia index using the EndoPAT device. Secondary outcomes will include other cardiovascular risk biomarkers, including arterial stiffness (pulse wave velocity), blood pressure, heart rate variability, proinflammatory blood parameters, self-reported fatigue, recovery needs, sleep quality and sleepiness, which will be assessed using validated questionnaires. Our study will address whether napping on the night shift can decrease cardiovascular risk through early cardiovascular biomarkers, including endothelial function, arterial stiffness and heart rate variability. If effective, such interventions could contribute to the development of more sustainable and health-conscious shift work practices, benefiting both workers and the organisations that employ them.

The study protocol is in accordance with ethical principles established by the 18th World Medical Assembly (Helsinki 1964) and received approval from an institutional review board ‘comité de protection des personnes EST III’ (23CH138). Written informed consent will be obtained from all participants.

NCT05955729; ClinicalTrials.gov 2023-A01109-36 Registered on 21 July 2023.

The analgesic and antipyretic paracetamol (acetaminophen) is generally considered safe in therapeutic doses. The most important toxic effect is hepatotoxicity after supratherapeutic doses or in the presence of risk factors (eg, malnutrition, alcoholism). According to the WHO analgesic ladder, a combination of a non-opioid analgesic such as paracetamol with a strong opioid is recommended as step III treatment of patients with chronic pain, despite limited evidence for this approach. The main aim of this study is to test the hypothesis that paracetamol does not provide clinically relevant benefits when added to strong opioids in patients with chronic pain.

Investigator-initiated, randomised, double-blind, placebo-controlled, non-inferiority trial at two Swiss hospitals. A total of 140 patients with chronic pain requiring strong opioids and paracetamol ≥1.5 g/day for at least 7 days will be enrolled and randomised to either continued combination treatment or strong opioid plus placebo. In the first study phase (days 1–7), patients receive identically looking capsules containing either paracetamol at the exact dose previously used or a placebo. During a second study phase (days 7–14), all patients stop the blinded study medication (paracetamol and placebo) with follow-up to day 14. Adherence will be assessed by pill count and measurement of paracetamol and opioid serum concentrations. Patients are instructed to use a pain diary daily during the whole study. The primary outcome is the average pain score on day 7 using a 10 cm visual analogue scale (VAS). A difference between groups of ≤8 mm will be considered clinically irrelevant. Secondary outcomes will include VAS pain score on day 14, number of opioid rescue doses used, subjective ratings of overall feeling of well-being, quality of life, nausea/vomiting, drowsiness and constipation, and other adverse events, and potential effects of study drug concentrations and opioid receptor and cytochrome P450 (CYP) genotypes on the observed differences.

The study was approved by the Ethics Committee (Ethikkommission Bern, reference number 2021-01518) and the Swiss Agency for Therapeutic Products (Swissmedic, reference number 701286). Results will be published in open-access policy peer-reviewed journals. The study is funded by the Swiss National Science Foundation (grant number 32 003B_201072).

NCT05088876.

Retroperitoneal sarcomas (RPS) are rare and often large malignancies that frequently require extensive surgery for complete tumour removal. Resections of the colorectum are part of the standard resection, this way contributing to complication rates, including anastomotic leakage or obstruction. Surgical strategies for stoma formation and colorectal reconstruction remain poorly defined. The Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q) study aims to explore surgical procedures and health-related quality of life (HRQoL) in patients undergoing colorectal procedures during RPS surgery.

COLOSARC-Q is a prospective, multicentre, non-interventional study and will recruit 120 patients with primary RPS who undergo colorectal resection as part of sarcoma surgery in a sarcoma referral centre in Germany or Switzerland. HRQoL is assessed using standardised questionnaires (EORTC QLQ-C30, QLQ-CR29) as well as semi-structured interviews by psycho-oncology services and patient advocates. Data will be collected via an electronic Case Report Form, encompassing demographic, clinical, surgical and outcome-related information. All data will be centrally analysed. For the assessment of quality of life, a qualitative analysis with content and context analysis, as well as evaluation of the questionnaires according to a standardised scoring system, is planned. The primary aim is to evaluate surgical techniques for bowel resection and reconstruction and their influence on the further course of disease. Secondary endpoints assess postoperative complications as well as tumour-, patient- and treatment-related factors.

Ethical approval was granted by the Ethics Committee II of the University of Heidelberg (approval number 2024-562; 13 June 2024). The data protection review was approved by the data protection officer of the University of Heidelberg. Participation of other centres in the study requires local ethical approval. All patients will be required to sign an informed consent form. Results of primary and secondary endpoints will be published.

NCT06943612; German Clinical Trials Registry (DRKS00034135).

This study evaluates how participants experienced and assessed a three-round Delphi study on the terminology of developmental language disorders in childhood. It compares participants who completed all rounds (completers) with those who withdrew early (dropouts) and aims to derive methodological quality criteria for future Delphi studies.

The evaluation is based on a Delphi study conducted in 2021/2022 across five German-speaking countries. After the final round, n=179 experts (40% response rate) completed a standardised survey assessing their expertise, motivation, reasons for discontinuation, time commitment and perceptions of questionnaire and feedback design. Responses from completers (n=156) and dropouts (n=23) were analysed descriptively.

Most participants had no prior experience with Delphi methods but rated the study positively and considered the topic highly relevant. Completers reported their subjective time commitment to be lower and rated the handling of the questionnaire more positively than dropouts. Feedback was used by nearly half of all experts and was more actively considered by completers. Lack of time was the most common reason for discontinuation.

The findings confirm the feasibility and acceptance of the Delphi method in interdisciplinary health research. In addition to established methodological principles, topic relevance, clear communication and time commitment emerged as key areas for expert motivation and engagement.