To explore the impact of acute worsening events (AWEs), defined as clinically relevant deteriorations in peak expiratory flow, reliever use and/or symptoms, on patients’ daily lives and identify behaviours linked to their recognition and management.

A qualitative international substudy was conducted in the Netherlands, Spain, the USA, Canada and the UK (2023–2024).

19 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from a randomised clinical trial participated. Interviews, triggered by AWEs and repeated 6 weeks later, were audio-recorded, transcribed and analysed.

Patients varied in identifying bad days, reporting inability to perform physical activities, symptom worsening or the need for add-on treatment. Recognition of AWEs depended on their duration: shorter events (

AWEs significantly impact daily life but vary widely in recognition and thresholds for seeking care. Limited awareness of daily disease variations may contribute to both under-reporting of worsening events to healthcare providers and suboptimal self-management in COPD.

NCT05492877.

Misophonia is a newly recognised sound sensitivity disorder with clinically significant symptoms affecting up to 18% of the population. It is characterised by extreme negative reactions to specific sounds which are often repetitive and generated by the human oral-nasal tract (eg, sniffing and eating sounds). Although misophonia currently has no standard treatment, research suggests that transcutaneous auricular vagus nerve stimulation (taVNS) holds promise therapeutically. This study aims to investigate both the effects of 4 weeks taVNS (compared with sham) on misophonia and related symptoms as well as its underlying neurophysiological mechanisms. To our knowledge, this is the first trial on taVNS in misophonia.

This is a single-centre double-blind sham-controlled trial in which 60 participants with clinically significant misophonia are randomly allocated in a 1:1 ratio to receive taVNS or sham stimulation. The intervention will be self-administered over 4 weeks (two times per day for 30 mins each). The primary efficacy outcome is self-reported misophonia severity with secondary outcomes, including mental health and audiological symptoms. In addition, all participants will undergo preintervention and postintervention testing, including MRI and physiology to investigate neurophysiological mechanisms underlying taVNS effects.

The study has been approved by the Brighton and Sussex Medical School ethics board (ER/GLP28/4). Results will be submitted for publication in peer-reviewed journals. Data will be anonymised and made available for sharing after completion of the study.

This trial is registered in ISRCTN; ISRCTN79500062.

Intravenous injection is one of the most frequently performed invasive nursing procedures in hospitals. However, patients may experience pain and anxiety during this procedure, which can affect patient satisfaction.

Colorectal cancer (CRC) is one of the most common cancers worldwide. Stage II/III patients undergo curative-intent surgery yet still face the recurrence risk. Detecting recurrences early provides the best opportunity for optimal treatment. We aimed to develop a microsimulation model to evaluate CRC management-associated outcomes based on current guidelines, including the performance of guideline-recommended surveillance in detecting recurrences.

Two separate individual-level state transition (microsimulation) models for colon and rectal cancer were built with a lifetime horizon using monthly cycles. The models integrated treatment and surveillance strategies per current guidelines.

The currently recommended surveillance modalities by National Comprehensive Cancer Network guidelines for surveilling patients with CRC after curative-intent surgery.

65-year-old patients with stage II and stage III CRC who underwent curative-intent surgery in the USA.

Cumulative recurrences, detected recurrences, detection rate, overall survival and recurrence-free survival in a 5-year horizon, as well as average life expectancy, were the outcome measures used.

Over 5 years, disease recurrence was observed in 9.5% of patients with stage II–III colon cancer and in 38.0% of patients with stage II–III rectal cancer. Of these, 82.5% and 85.5% were detected via surveillance, respectively, within 5 years. The predicted 5-year overall survival was 86.0% for colon cancer and 69.3% for rectal cancer, with corresponding recurrence-free survival rates of 78.9% and 53.8%. Based on current guidelines-recommended surveillance, detecting one colon cancer recurrence requires 148 carcinoembryonic antigen (CEA) tests, 37 CT scans and 21 colonoscopies. In contrast, detecting one rectal cancer recurrence requires 31 CEA tests, 8 CT scans and 4 colonoscopies.

Our validated model suggests that relative to an optimal benchmark in which all recurrences are detected, recurrence detection under current guidelines may be suboptimal, indicating room for improvement. As new tests emerge, this model could be a valuable tool for evaluating existing clinical practices and the potential of new tests to enhance patient outcomes.

Traditional encounter-based analyses overlook downstream costs and complications that follow emergency department (ED) care. To enable more comprehensive evaluations, we developed standardised episode of care definitions for five common, high-cost conditions: chest pain, congestive heart failure (CHF), pneumonia, chronic obstructive pulmonary disease (COPD) and suicidality.

A two-round modified Delphi panel study was conducted following a literature review and evidence synthesis. Using structured surveys with anonymous feedback, panellists rated candidate criteria. To be retained in the final episode definitions, criteria were required to meet a predefined validity threshold without panellist disagreement. Data were analysed descriptively, and meeting deliberations were recorded and reviewed thematically.

Virtual, supported by an online survey platform.

A multidisciplinary panel of 11 experts in emergency medicine and relevant clinical specialties with 9 members participating in each round.

Criteria to determine inclusion, exclusion (including pre-trigger, post-trigger and event exclusion) and risk-adjustment standards for constructing ED-based episodes of care.

Candidate criteria were presented to the panel by condition: 30 for chest pain, 54 for CHF, 30 for COPD, 79 for pneumonia and 375 for suicidality. Following deliberations and re-rating, the number of valid criteria was reduced, primarily in the episode exclusion category. Thematic analysis highlighted trade-offs between episode exclusion criteria and the use of risk adjustment to account for heterogeneity.

Operational definitions for ED-based episodes of care for five conditions were established. These may support healthcare administrators, policymakers and researchers in evaluating variation in ED care delivery and its downstream cost and outcomes.

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

jRCTs062240066

Demographic change is resulting in a growing number of individuals requiring nursing care, while the availability of professional caregivers is simultaneously declining. This imbalance places increasing pressure on care provision, particularly in home settings and rural areas. Primary care services are also under pressure. Digital solutions such as teleconsultations are considered promising strategies to support intersectoral collaboration in long-term care and to mitigate existing gaps in service provision.

Seven teleconsultation projects in long-term care are being conducted using a mixed-methods design aligned with the phases of the Medical Research Council framework: with a focus on the feasibility phase. Data on structural conditions, usage patterns and user acceptance will be collected through standardised instruments (including Unified Theory of Acceptance and Use of Technology and Fit between Individuals, Task and Technology). In addition, focus groups and interviews will be carried out. The quantitative analysis will include descriptive and inferential statistical methods and will be complemented by a cost–consequence analysis. The qualitative data will be analysed using structuring content analysis. The aim is to provide a context-informed and theory-informed assessment of the implementation and potential impact of telemedical consultations.

The study has been approved by the Ethics Committee in Tübingen. Participation is voluntary and based on written informed consent. Data protection is ensured in accordance with the GDPR (General Data Protection Regulation); all data are pseudonymised and processed separately. Results will be communicated in a target group-appropriate manner and published in scientific journals. Practice-oriented recommendations will be developed to support the further advancement of telemedical care in nursing.

Geriatric patients are at increased risk of developing postoperative neurocognitive disorders, including delirium. Existing evidence-based perioperative interventions need to be implemented into routine care to improve postoperative outcomes. In this qualitative interview study, we wanted to collect stakeholder experiences to understand the implementation process of a multi-component intervention to prospectively facilitate future implementation.

Descriptive qualitative evaluation research.

Single-centre at a German major urban academic hospital.

22 interviews were conducted with n = 7 geriatric patients after surgery who had received a comprehensive geriatric assessment and an individualised perioperative multi-component intervention, and n = 15 healthcare professionals, including nurses, physicians and medical assistants working in the perioperative care.

Semi-structured interviews were conducted, addressing the implementation procedure of the multicomponent intervention and the experience with it within the routine setting.

The implementation outcomes were adoption, acceptance, appropriateness, feasibility and sustainability.

Transcribed audio recordings were analysed with directed content analysis. Most intervention components could be adopted during the pilot trial. Implementation barriers were identified. Limited resources and logistic constraints threatened feasibility and sustainability. Acceptance of patients and healthcare providers regarding an intervention depended on its perceived appropriateness, which varied per intervention component, workspace and duration of the implementation.

We were able to replicate and extend previous findings on the implementation of improved perioperative care. To facilitate the implementation success and motivation to implement evidence-based measures, resource allocation needs to be adjusted and standard operational procedures, as well as the cross-sectional collaboration, must be simplified.

NCT03325413.

Curable sexually transmitted infections (STIs) heavily rely on laboratory testing methods. Unfortunately, these diagnostic tools are infrequently used in certain regions of the country, which often results in suboptimal treatment for these infections. This study aimed to assess the prevalence of selected curable STIs among pregnant women.

Cross-sectional study.

The study was conducted in an antenatal care (ANC) unit in one of Southern Ethiopia’s general hospitals.

A total of 244 consecutive pregnant women attending the ANC follow-up were recruited for the study. All pregnant women have equal opportunity to participate; however, women who declined to be interviewed or give a sample were excluded. Pregnant women on antibiotic treatments were also excluded.

The study assessed the prevalence of selected curable STIs and associated factors. Neisseria gonorrhoea was diagnosed by culture, trichomoniasis by microscopic examination and syphilis by serological testing using a rapid diagnostic test cassette. Test results for trichomoniasis and gonorrhoea were obtained from vaginal and endocervical swabs. Factors associated with curable STIs were evaluated by bivariable and multivariate logistic regression.

The overall prevalence of curable STIs was 16.4% (40/244), with prevalence of 2% for gonorrhoea, 15.2% for trichomoniasis and 1.2% for syphilis. Alcohol intake (adjusted OR (AOR)=3.0; 95% CI 1.1 to 8.3; p=0.030), symptomatic treatment (AOR=3.6; 95% CI 1.4 to 8.6; p=0.004), residency (AOR=3.2; 95% CI 1.2 to 9.1; p=0.022) and pain while urinating (AOR=4.0; 95% CI 1.6 to 9.7; p=0.002) were all found to be associated with the existence of these STIs. This study has limitations; the cross-sectional study design and small sample size would provide limited information about factors associated with curable maternal STIs.

The study reveals a high prevalence of curable STIs among the participants, highlighting the need for further research aimed at improving their management during pregnancy.

To provide the first national estimate of syphilis prevalence among people who inject drugs (PWID) in Georgia, alongside updated HIV prevalence and associated risk behaviours, and to identify factors associated with infection.

Cross-sectional Integrated Bio-Behavioural Surveillance Survey conducted in 2022. Respondent-driven sampling was used to recruit PWID. Data were collected through standardised face-to-face interviews using structured questionnaires, and venous blood samples were collected for laboratory testing. HIV was diagnosed by serology, and syphilis was assessed using a two-step algorithm (Rapid Plasma Reagin screening with Treponema pallidum haemagglutination assay confirmation). Logistic regression models were applied to identify correlates of infection.

The study was conducted in community settings across seven major cities of Georgia that represent the main urban centres with large PWID populations. Survey implementation was supported by local peer-led and community-based harm reduction organisations with established trust and access to PWID networks, facilitating participant recruitment and ensuring feasibility.

HIV prevalence was 0.9% and syphilis prevalence 2.1%. Coinfection with HIV and syphilis was observed in 0.2% of participants. HIV infection was significantly associated with longer duration of injection drug use (adjusted OR (aOR) 0.2; 95% CI 0.5 to 0.9) and lack of access to HIV prevention services (aOR 2.8; 95% CI 1.1 to 7.8). Syphilis prevalence was significantly lower among PWID who had not had casual or paid sex in the past year (OR 0.06; 95% CI 0.02 to 0.2). Unsafe sexual behaviours were common: 25.8% reported sex with a casual partner in the past year, 12.3% reported a paid partner, and only around half used condoms consistently with these partners.

Despite a relatively low HIV prevalence, syphilis prevalence among PWID in Georgia highlights ongoing sexual risk behaviours. Current harm reduction programmes primarily address injection-related risks, with limited sexually transmitted infection (STI) prevention efforts. Expanding sexual health interventions within harm reduction services, including STI screening, structured counselling and safe sex education, is essential to reduce STI transmission and improve health outcomes among PWID.

Employees in sheltered workplaces face greater challenges in maintaining a healthy and vitality-enhancing lifestyle due to physical, mental and psychosocial disabilities. While workplace health and vitality programmes are particularly relevant for this group, evaluation of programmes in this setting remains limited. This paper presents a protocol for a realist evaluation of a sheltered workplace’s vitality programme aimed at physical, mental and social sources of vitality.

Using a multimethod design with adaptive qualitative methods, we developed an initial programme theory that describes how context and mechanisms of the sheltered workplace’s vitality programme influence the outcomes related to physical activity, healthy eating and social interaction. The protocol explains how we will collect and synthesise qualitative data, interviews, observations and focus group discussions, to refine and validate this initial programme theory and further evaluate the vitality programme. We aim to conduct at least 15 interviews, 15 observations, 3 focus group discussions and 1 final validating focus group. The study includes recipients of the intervention, namely individuals with varying work abilities, as well as other key stakeholders involved in the vitality programme. In this way, we will get insights into how to promote vitality-enhancing behaviours. Our context-sensitive methodology offers both scientific and practical value for future research in similar settings.

Ethical approval was granted through the Ethics Review Committee of Erasmus University Rotterdam (application number: ETH2324-0939). Findings will be disseminated through presentations, conferences, social media and peer-reviewed publications.

The aim of this study is to identify and analyse research priorities across the osteopathic profession internationally, to determine how different interested parties conceptualise research importance and to examine how contextual factors influence research prioritisation.

A mixed methods sequential exploratory design combining an umbrella review, a thematic analysis, an expert consensus agreement and an international cross-sectional survey was used to define, validate and evaluate research priorities.

An international online survey, available in nine languages, was distributed through professional osteopathic organisations and network worldwide, a patient representative organisation and social media.

2229 respondents including patients (7.4%), practitioners (42.1%), students (17.4%), educators (13.5%), researchers (5.0%) and policy makers (4.3%) from across 42 countries.

Primary outcomes were interested party’s conceptualisation of research importance and validation of the priorities in Research for Osteopathic Care (PROCare) framework. Secondary outcomes included current research priorities across interested parties groups and influence of contextual factors on prioritisation.

Three distinct approaches to priority-setting emerged: conservative (42.9%), sceptic (20.2%) and enthusiast (36.9%). Organising research priorities as a construct built from domains and subdomains was shown to be internally valid (Cronbach’s α=0.911). ‘Patient safety’ (nominated by 82% of relevant countries) and ‘physical activities and mobility’ (51.0%) were the most prioritised subdomains. ‘Digital health’ ranked lowest (28th of 28 subdomains). Significant geographic variations were observed mainly for the overall importance to most research domains. Strong consensus emerged around core priorities including patient safety, physical activity promotion and understanding treatment mechanisms.

The PROCare framework provides a validated structure for evaluating osteopathic research priorities across diverse interested parties. While geographic variations exist in priority emphasis, fundamental agreement on key research domains suggests potential for internationally coordinated research strategies. Future work should focus on developing mechanisms to ensure balanced representation of conservative, sceptic and enthusiast perspectives in research planning.

This study aimed to assess the clinical severity and risk factors of diabetic ketoacidosis (DKA) at type 1 diabetes (T1D) diagnosis in children under 18 years in Greater Poland from 2006 to 2023, including temporal trends and the impact of COVID-19.

A retrospective cross-sectional study.

Greater Poland Province, Poland.

The study cohort comprised 2432 European Caucasian children (boys: 1335) aged 0–18 years with newly diagnosed T1D admitted to one hospital between 2006 and 2023.

DKA and its severity were classified according to the International Society for Pediatric and Adolescent Diabetes criteria. The multivariable analysis assessed the following risk factors for DKA at T1D diagnosis: age, sex, seasonality and the presence of T1D autoantibodies. Poisson regression models with a log link were used to assess the impact of the COVID-19 pandemic on monthly DKA cases at T1D onset, including time, pandemic period and their interaction as predictors.

DKA was diagnosed in 51.4% (1248) of newly diagnosed T1D patients, with 24.9% classified as mild, 14.4% as moderate and 12.1% as severe. Modest sex-related differences were observed, with DKA at T1D onset slightly more common in males than females (52.8% vs 47.2%). However, when comparing the DKA and non-DKA groups, a higher proportion of females presented with DKA (47.2%) than those without DKA (42.9%) (p=0.034). Children aged 0–2 years showed the highest DKA prevalence at T1D onset (76.4%), with a significant proportion experiencing severe DKA (33.6%). Factors like age, sex, season, glycaemia, glycated haemoglobin and autoantibodies did not independently predict DKA risk. The COVID-19 pandemic did not affect DKA rates at diagnosis.

The frequency of DKA is high, and its severity is substantial among children with newly diagnosed T1D in Greater Poland. Children aged 0–2 years are at the greatest risk of severe DKA at onset, underscoring the need for earlier recognition and intervention in this age group. Our findings emphasise the critical importance of increased awareness, education, point-of-care glucose testing, and targeted strategies such as T1D screening programmes to reduce the occurrence of DKA.

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

NCT06021184.

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.