This study aimed to describe the types of psychological and physical symptoms experienced by healthcare professionals who became second victims after a patient safety incident and the impact of the incident on their social and professional lives.
Scoping review.
JBI methodology for scoping reviews and PRISMA-ScR for reporting were followed.
The search was conducted on June 13, 2024, using the CINAHL (EBSCO), Scopus, PubMed (Medline), Medic and PsycInfo (EBSCO) databases. A grey literature search was also conducted.
A total of 96 papers were included. Healthcare professionals experienced psychological symptoms such as anger, sadness and guilt after a safety incident. Physical symptoms were reported, including symptoms related to sleep and gastrointestinal symptoms. At the professional and social levels, the incident affected their work, relationships and well-being. Positive impacts were also noted.
This study provides a comprehensive overview of healthcare professionals' experiences after safety incidents. In addition, this study also captured the positive impacts of safety incidents, such as learning from mistakes.
By recognising the symptoms and impacts associated with the second victim syndrome, appropriate support can be provided for healthcare professionals.
The findings of this study can be used to identify the relevant harm to professionals after a safety incident, which could help to improve the well-being of these workers.
No patient or public contribution.
Open Science Framework, https://archive.org/details/osf-registrations-5cdmu-v1
This study was an investigation of the key factors influencing nurse retention and attrition focusing on the perspectives of current and former nurses within the context of the ongoing nursing shortage exacerbated by the COVID-19 pandemic.
This descriptive, cross-sectional study was designed to explore the complex dynamics of nurse retention and attrition in a rural and northern academic hospital in northwestern Ontario.
An online survey was administered to current and former nurses to compare the perspectives of those with no intention of leaving the organisation, those contemplating departure within the next year, and those who had reduced their work hours in the past 5 years.
Of the 288 respondents, 47% indicated no intention to leave and 17% reported having already left the organisation. The primary reasons for attrition included excessive workload demands, challenges maintaining a healthy work-life balance and dissatisfaction with management practices and organisational support. Respondents recommended improving leadership effectiveness, increasing staffing levels and implementing retention-focused initiatives to enhance job satisfaction and reduce turnover.
This study underscored the urgent need for strategic interventions tailored to retain nursing staff, particularly in rural and northern communities already facing significant recruitment and retention challenges. By addressing workload pressures, enhancing work-life balance, strengthening leadership and offering retention initiatives, health care organisations can improve job satisfaction and reduce attrition. System-level changes are essential to creating a sustainable and supportive environment for nursing professionals.
The findings highlight the critical need for immediate action to address the nursing crisis in rural and northern health care settings. They emphasise the importance of systemic interventions aimed at improving staffing levels, leadership practices and overall work conditions to safeguard the future of nursing in these underserved regions.
No patient or public contribution.
This research will contribute to the extant literature on the retention and attrition levels of nursing by offering a unique perspective from a rural and northern academ. The findings may help to guide hospital administrators to develop targeted strategies to enhance nurse retention rates within their organisations. By prioritising nurse satisfaction, these efforts will foster positive nurse–patient interactions and improve overall care outcomes.
This study is reported according to STROBE guidelines.
Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.
MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.
This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.
Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.
by Simon Knobloch, Philipp Haul, Saskia Rusche, Heiko Paland, Darius Zokai, Moritz Haaf, Jonas Rauh, Christoph Mulert, Gregor Leicht
When confronted with dichotically presented syllables, right-handed healthy individuals tend to consciously perceive syllables presented to the right ear more often. This phenomenon, known as the right-ear advantage, is driven by delayed processing of information from the left ear in left temporal auditory cortex due to its indirect relay through the corpus callosum. In contrast, less is known about about the corresponding mechanisms for stimuli processed in the right temporal hemisphere. In this study, we developed a melody-based dichotic listening paradigm designed to induce a left-ear advantage. This novel paradigm, alongside a classical syllable-based paradigm was tested in 40 healthy right-handed participants. We also examined the influence of musical education on lateralization of auditory processing. Our results revealed a significant left-ear advantage for the perception of dichotically presented melodies and replicated established findings of a right-ear advantage for syllables. No group differences emerged between participants with or without current or past musical practice. However, among those with musical training, a greater number of years of practice was associated with a reduced right-ear advantage for syllables and an increased report of melodies presented to the left-ear. These findings suggest that the left-ear advantage in dichotic perception of melodies reflects right hemispheric processing of musical stimuli. Moreover, monitoring of the left ear seems to be altered by musical practice. Future research using neuroimaging techniques will be necessary to confirm this finding.Severe mental disorders are associated with increased risk of metabolic dysfunction. Identifying those subgroups at higher risk may help to inform more effective early intervention. The objective of this study was to compare metabolic profiles across three proposed pathophysiological subtypes of common mood disorders (‘hyperarousal-anxious depression’, ‘circadian-bipolar spectrum’ and ‘neurodevelopmental-psychosis’).
751 young people (aged 16–25 years; mean age 19.67±2.69) were recruited from early intervention mental health services between 2004 and 2024 and assigned to two mood disorder subgroups (hyperarousal-anxious depression (n=656) and circadian-bipolar spectrum (n=95)). We conducted cross-sectional assessments and between-group comparisons of metabolic and immune risk factors. Immune-metabolic markers included body mass index (BMI), fasting glucose (FG), fasting insulin, Homeostasis Model Assessment-Insulin Resistance (HOMA2-IR), C reactive protein and blood lipids.
Individuals in the circadian-bipolar spectrum subgroup had significantly elevated FG (F=5.75, p=0.04), HOMA2-IR (F=4.86, p=0.03) and triglycerides (F=4.98, p=0.03) as compared with those in the hyperarousal-anxious depression subgroup. As the larger hyperarousal-anxious depression subgroup is the most generic type, and weight gain is also a characteristic of the circadian-bipolar subgroup, we then differentiated those with the hyperarousal-anxious subtype on the basis of low versus high BMI (2 vs ≥25 kg/m2, respectively). The ‘circadian-bipolar’ group had higher FG, FI and HOMA2-IR than those in the hyperarousal-anxious-depression group with low BMI.
Circadian disturbance may be driving increased rates of metabolic dysfunction among youth with emerging mood disorders, while increased BMI also remains a key determinant. Implications for assessment and early interventions are discussed.
The objective of this study was to understand primary care clinician perspectives on a novel linked health data system to facilitate diabetes prevention for individuals with a history of gestational diabetes mellitus (GDM). We used the conceptual example of linking the National Gestational Diabetes Register with primary care electronic health records to understand clinicians’ views on potential implementation.
A qualitative study of semistructured interviews with primary care clinicians.
Australian primary care.
Primary care clinicians (n=14). Inclusion criteria were: general practitioners (GPs), practice nurses and/or diabetes educators working in primary care in Australia, and seeing individuals with a history of GDM; aged 18 years and over; and willing to voluntarily contribute to the project. There were no exclusion criteria.
Clinicians’ views on acceptability, feasibility and utility were characterised by realistic optimism for a linked data system to improve GP workflow and patient outcomes. Clinicians noted existing pressures on primary care and patient concerns regarding confidentiality and privacy, and that these factors should be considered in the development process. Clinicians envisaged three functions for their clinical management systems: (1) automatically updating a patient’s past history; (2) generating actionable alerts and (3) generating recall lists.
Primary care clinicians were unanimously supportive of a linked health data system to facilitate diabetes prevention. Consistent with previous studies, we identified the key clinician-related enabler as the integration into existing GP workflows to facilitate pro-active clinical care. Point-of-care tools and preventative care consultations could increase the uptake of screening and provide opportunities for patient education post partum.
In combination with effective prevention programmes, and health policy and system supports, linked health data systems could be part of the equation for type 2 diabetes prevention for individuals with a history of GDM. Larger acceptability, feasibility, co-design and implementation studies are recommended.
by Ismat Tasnim, Md. Asif Iqbal, Ismat Ara Begum, Mohammad Jahangir Alam, Morten Graversgaard, Paresh Kumar Sarma, Kiril Manevski
Food insecurity and agriculture in South Asia, including Bangladesh, pose significant threats to the well-being and livelihoods of its people. Building adaptive capacities and resilient food systems is crucial for sustainable livelihoods. This study employs the Resilience Index Measurement and Analysis II framework to construct a Resilience Capacity Index (RCI) and analyze its relationship with food security using data from the Bangladesh Integrated Household Survey 2018. The study applies Exploratory Factor Analysis and Structural Equation Modeling to examine the impact of key resilience components such as Access to Basic Services, Adaptive Capacity, and Assets on household resilience. The findings reveal that access to basic services, land assets, and farm equipment positively influences households’ resilience capacity. However, the presence of livestock assets has a negative impact, potentially due to market volatility, climate vulnerability, and disease outbreaks. Additionally, adaptive capacity has a positive but insignificant influence on RCI, suggesting that without enhancing economic opportunities, institutional support, and inclusive development strategies, adaptive capacity could not be enough to foster resilience. However, resilient capacity enhances food security metrics such as the Food Consumption Score and Expenditure. These findings underscore the importance of policies that focus on increasing and maintaining access to basic services, promoting sustainable land management practices, and strengthening social safety nets. This study emphasizes the importance of focusing on livestock assets to ensure their sustainability by stabilizing the livestock market, improving veterinary services, and providing subsidies to reduce maintenance costs.To (1) analyse managers' experiences with handling patient safety incident reports in an incident reporting software, identifying key challenges; (2) analyse the incident report processes from the managers' perspective; (3) examine managers' perceptions of ways to support and improve health professionals' experiences of report-handling processes; and (4) investigate how, from their point of view, incident reporting software should be developed in the future.
A descriptive qualitative study.
Interviews and focus group discussions on Microsoft Teams from 11/2024 to 3/2025, including 16 participants, analysis with deductive and inductive content analysis.
Of 16 participants, 15 were managers and one was a patient safety expert. Most were nurse managers (n = 9). Four discussion themes were divided into 30 categories. Participants highlighted the need to improve the reporting software's terminology, classification and analysis tools. The use of artificial intelligence was desired but not currently integrated into the software. Participants were unsure of their skills to use all the software features. Clear and transparent handling processes, feedback, managers' behaviour and communication methods were seen as key to improving staff's experience with report processes. A real-time warning system was considered beneficial for various incident types. Specific questions must be answered before further developing such systems.
This study deepened the understanding of reporting software's challenges regarding its handling features. The handling processes of incident reports had multiple shortcomings, which may negatively affect health professionals' experiences in report handling. Real-time warning systems could assist healthcare managers in processing reports.
Organisational-level guidance for incident report processing is needed. Improvements to report processing and reporting software can improve shared learning and understanding of the status of patient safety.
No patient or public contribution.
COnsolidated criteria for REporting Qualitative research Checklist.
Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.
In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.
Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.
DRKS00033284.
Traumatic brain injury (TBI) is a leading cause of mortality and disability worldwide. In the USA, individuals who racially identify as African American or Black experience disproportionately higher rates of TBI and sustain worse prognosis compared with White patients; however, this population continues to be under-represented in contemporary translational research agendas. This protocol aims to comprehensively evaluate and synthesise what is currently known about the molecular epidemiology of TBI outcome among individuals of Black racial identity or African ancestry.
This review will use the established scoping review framework from the Joanna Briggs Institute. The search strategy will be implemented in PubMed (MEDLINE) and expanded to Embase and Cochrane CENTRAL Library (Wiley) databases in the final review. The date range will span from database inception to 20 July 2025 (date of final search). A two-stage screening process will be performed first at the title and abstract level before full-text assessment. Screening will be performed by two independent reviewers and discrepancies will be reconciled by a third reviewer. Articles that meet the following inclusion criteria will be considered: we will include human studies that investigate molecular and biochemical markers associated with TBI outcome. Studies must include individuals who are (A) of Black or African American racial identity, (B) of African ancestry and/or (C) performed in Sub-Saharan African countries. There is no eligibility criteria related to participant age, sex or gender. Eligible studies will be limited to English, Spanish or French. Data extracted from will be analysed and presented as written narrative, summary statistics of study characteristics and graphical or tabular displays.
Ethical approval is not required for this scoping review. The results of this review will be disseminated through peer-reviewed publications and academic conferences.
Ages of attainment for early gross motor milestones have been widely studied, but definitions and measurement methods have varied greatly. Since delays in motor milestones have been used extensively as one of the earliest indicators of atypical development, it is imperative to establish a universal understanding of the methods and results reported on motor milestones in typically developing children. Therefore, the primary aim of this scoping review is to provide an overview of recent studies reporting ages of onset for independent sitting and walking in typically developing children worldwide; this will be achieved by summarising how these milestones have been operationalised and evaluated, the samples from whom these data have been drawn, and the reported ages of acquisition.
To meet inclusion criteria, articles must: be original research papers published in any language since 2003, contain a sample of typically developing children and report actual ages of onset for independent sitting and/or walking. To conduct this scoping review, the Joanna Briggs Institute methodological framework will be used. Search terms will include variations of the following concepts: acquisition of motor milestone (independent sitting and/or walking), age of onset, infancy. Six databases (CINAHL Plus, Embase, PsycNet: PsycINFO & PsycArticles, PubMed, Scopus, Web of Science: Core Collection) will be searched. Records from these databases will be screened for eligibility. Two people will independently review each record during title and abstract screening, and three people will independently screen full texts and extract data. Results will be displayed in tables, graphs and narrative summaries in the scoping review.
As the review will only include previously published data, ethics approval is not required. Findings will be shared at scientific conferences and in a peer-reviewed journal.
The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.
Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.
Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.
The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.
CRD42024597624.
Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.
HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.
The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.
Sleep disturbances are highly prevalent among individuals with psychiatric conditions and significantly impair cognitive, emotional and behavioural functioning. Pharmacotherapy for sleep disturbances carries a risk of dependence and adverse effects, while behavioural therapies are often insufficient. Therefore, there is an urgent need for novel interventions. Non-invasive brain stimulation (NIBS) techniques, including repetitive transcranial magnetic stimulation, transcranial electrical stimulation and electroconvulsive therapy, have shown potential in modulating neural circuits involved in sleep regulation, yet their clinical utility remains uncertain. This protocol outlines a systematic review aiming to evaluate the efficacy, safety and optimal parameters of NIBS for treating sleep disturbances in psychiatric conditions.
The review will adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and is registered with PROSPERO. Two reviewers will independently perform a literature search, extract data and assess research quality. A comprehensive literature search will be conducted in four databases: PubMed/MEDLINE, Cochrane Library, Embase and Web of Science. Eligible studies will comprise randomised and non-randomised controlled trials, open-label studies, observational designs, case reports and case series. Analysed outcomes will include subjective and objective sleep measures, daytime functioning, changes in psychiatric symptoms and adverse events. Risk of bias will be assessed using the Cochrane Risk of Bias Tool, ROBINS-I and the Newcastle-Ottawa Scale. Where possible, data will be synthesised through meta-analysis; otherwise, tabular summary and narrative synthesis will be provided. The certainty of evidence will be assessed using the grading of recommendations assessment, development and evaluation framework.
No ethical approval is required as this study will involve analysis of already published data. Findings will be disseminated via peer-reviewed publication and conference presentations.
CRD420251053488.
The healthcare sector has significant environmental impacts, particularly through greenhouse gas emissions. Reducing its climate footprint is therefore essential for achieving political goals such as net-zero and climate-friendly healthcare. While health economic evaluation (HEE) methods compare the costs and consequences of two or more interventions, these analyses rarely consider climate impacts. Some studies have begun to determine climate impacts parallel to or integrated into HEEs. Life cycle assessment (LCA) could be used to integrate climate impacts by considering these results as effects or monetised climate footprints. However, a reporting standard is needed for using these climate-extended economic evaluations in evidence-based decision-making. This protocol describes using an online Delphi process to incorporate climate impacts into the Consolidated Health Economic Evaluation Reporting Standard (CHEERS), called CHEERS Climate Extension (CHEERS ClimatE).
The development of CHEERS ClimatE will proceed through five key stages. First, the preliminary steering group develops in consultation with an advisory board a proposal for the CHEERS ClimatE reporting standard based on a transparency checklist that combines three standards for carbon footprint calculations into the CHEERS framework. The mapping was complemented by reviewing studies that incorporate climate impacts in HEE. Second, for the Delphi process, international experts in HEE and LCA with at least one year of academic experience will be invited to participate in an online pre-survey. We aim to recruit at least 40 participants. Expecting various drop-outs, we aim to reach a consensus with at least 20 participants per Delphi round. Third, an expected three-round Delphi process will be conducted to validate and refine the proposed elements. Participants will rate each item using a 9-point Likert scale and will have the opportunity to comment on each item and propose new items. Consensus is defined with the target of a 70% agreement. Unless consensus is reached, a moderated video conference may be held as a fourth round. Fourth, following other CHEERS extensions, the consented checklist will be piloted using thematically relevant case studies. While substantial changes are not anticipated, minor revisions to individual items may be considered and ratified by the steering group and advisory board. The fifth stage is the publication of the final checklist.
This study has been approved by the ethics committee of the University of Bremen (2024–25). The findings of the Delphi study will be published in a peer-reviewed journal and presented at conferences.
Outcome after surgery depends on both patient-related as well as procedure-related risks. Complications after surgery are a significant burden to patients and to the health system. A vast amount of often unstructured data from different sources are generated during surgery, which contain valuable information associated with outcome. Advances in computer hardware and machine learning now increasingly facilitate the development of prediction models in standardised, parametric, information-rich areas such as the perioperative setting. For the development and validation of risk scores and prediction models, high-fidelity data sources are required to arrive at meaningful and reliable predictions. However, data quality standards in retrospective studies are rarely met. Therefore, the prospective Heidelberg Perioperative Deep Data Registry and Biomaterial Bank (HeiPoDD - Registry and Bio Bank) was started to implement a clinical data base and a corresponding biobank merging the entirety of available clinical records.
The HeiPoDD - Registry and Bio Bank is a study-driven, prospective, single-centre observational registry data base and biomaterial bank. It contains data and material from eligible patients who give informed consent and undergo elective non-cardiac high-risk surgery at the surgical centre of the Heidelberg University Hospital. The screening for eligibility started in January 2022, with no maximum sample size specified in advance. Routine data are recorded and stored during hospital stay and potential readmissions within 90 days after index surgery. The data are merged with the potentially available genome, proteome, flow cytometry, and bio signal data. Endpoints are obtained from routine observations, stored data in the hospital information system and follow-up visits. Further, data and biological specimens from separate perioperative studies with the patients’ consent can be transferred into the HeiPoDD - Registry and Bio Bank as well. This large-scale data collection will allow the calculation of endpoint-specific prediction models using logistic regression models as well as machine learning models. The first 1040 patients included in the HeiPoDD - Registry and Bio Bank are also included in the HeiPoDD study.
The trial protocol and subsequent amendments were approved by the ethics committee of the University of Heidelberg (S-745/2021). Participating patients’ data will be entered only in pseudonymised form. Data and biomaterials will be kept for up to 30 years. The findings will be disseminated in peer-reviewed academic journals.
DRKS00025924, registered on 2021-11-12.
Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.
This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).
The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.
Explore the care escalation process initiated by parents concerned about their hospitalised child's deterioration and healthcare providers' response to parental concerns.
A qualitative study using Charmaz's constructivist grounded theory.
Participants included healthcare providers, cultural mediators and parents of children hospitalized for ≥ 3 days, who had experienced previous urgent intensive care admission or parental concern during hospitalization, in a tertiary pediatric hospital. Data were collected through focus groups, and analyzed using a grounded theory methodology with NVivo Software.
A total of 13 parents, 7 cultural mediators and 68 healthcare providers participated in 16 focus groups. Two main categories were identified: (1) Parents navigating the uncertainty of the escalation system to get a response; (2) Healthcare providers balancing parents' concerns, their own situation awareness, escalation processes and team relations. We developed a Grounded theory called ‘Parents Supporting Timely Escalation Processes’ (P-STEP). By monitoring their children, parents identify early signs of deterioration and advocate for escalation. Reasons for concern are their child's behaviour, communication failure and admission on an off-service ward. Parents escalate by contacting ward providers, their child's specialist or the most trusted staff and, only selected parents, the Rapid Response Team. Staff escalate parents' concern according to their own situation awareness, parent evaluation and ward escalation practices. Parent's emotions and trust are influenced by the timeliness and type of staff response.
While some parents effectively advocate for their child, others face obstacles due to unclear and lack of formal care escalation systems. Understanding how parents escalate care and healthcare providers respond is essential to identify facilitators, barriers, key stakeholders, and implement a formal system for parent-initiated escalation of care.
Integrating parents into processes of escalation and rapid response systems could optimise early recognition and improve responsiveness in paediatric deterioration.
The study adheres to the COnsolidated criteria for REporting Qualitative research (COREQ) guidelines.
Parents and HCPs participated as interview respondents.
Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.
The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.
The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.
ClinicalTrials.gov ID: NCT05681962. Registered January 2023.