Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.

NCT06774820.

Several antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.

We will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.

The Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.

NCT06845332.

In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

NCT06719245. Dutch trial registry: NL87196.058.24

To investigate the occurrence of depression and mental health disorders other than depression among Brazilian people with intellectual disabilities, analysing data from a national household survey.

Cross-sectional epidemiological study using data from the 2019 National Health Survey (PNS).

Brazil, nationwide data collection in urban and rural private households.

272 499 individuals, among whom 1.2% (n=3198) reported intellectual disabilities.

Self-reported depression and mental health disorders other than depression (anxiety, panic, schizophrenia, bipolar disorder, psychosis or obsessive–compulsive disorder (OCD)), either isolated or comorbid.

Among people with intellectual disabilities, 43.2% reported at least one mental health disorder versus 13.7% without disabilities. In adults aged 0–59 years, intellectual disability was associated with higher odds of depression (adjusted OR (aOR) 3.25, 95% CI 1.76 to 6.00), mental health disorders other than depression (aOR 12.23, 95% CI 7.52 to 19.90) and depression associated with other mental health disorders (aOR 14.34, 95% CI 7.92 to 25.96). In older adults (≥60 years), risks also remained elevated: depression (aOR 1.71, 95% CI 1.04 to 2.79), mental health disorders other than depression (aOR 4.33, 95% CI 2.09 to 8.94) and depression associated with other mental health disorders (aOR 2.98, 95% CI 1.49 to 5.95). Women with intellectual disabilities were more likely to report depression and multimorbidity, while men more often reported non-depressive disorders. Poorer self-perceived health was consistently linked to worse outcomes across age groups.

Mental health disorders and their comorbidities are significantly more prevalent among people with intellectual disabilities in Brazil. These findings highlight the urgent need for inclusive, equitable and specialised mental healthcare policies.

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

A retrospective cohort study.

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.

The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.

Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

NCT06245499.

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

NCT05991453.

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

The development of mental disorders is multifactorial across the lifespan. The introduction of the exposome concept has enhanced the understanding of life-course environmental factors by encompassing the totality of environmental exposures. While most studies on chronic diseases have applied a single-exposure approach, the exposome approach remains underutilised in mental disorder research. There is a need to better recognise the environmental factors considered in exposome analysis of mental disorders, the methodologies used and the gaps reported. This scoping review aims to map the evidence on the relationship between the exposome and mental disorders across the lifespan, identifying and describing the methodologies used and highlighting the gaps reported.

This scoping review will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and the Population-Concept-Context approach. It will include observational and interventional studies involving populations of all ages in the community or healthcare settings. The search strategy will contain indexed terms in MEDLINE and will be adapted for CINAHL (EBSCO), Scopus, Embase and PsycINFO without restrictions on language or date of publication. For the selection of articles, two independent researchers will screen articles by title and abstract, followed by a full-text assessment. Afterwards, the extracted data will be summarised using a narrative and descriptive analysis.

Ethics approval is not required for this scoping review. Dissemination activities will include peer-reviewed publications and academic presentations.

To assess the magnitude of elective surgery cancellation and associated factors among scheduled patients at Debre Markos Comprehensive Specialized Hospital, Amhara region, North West Ethiopia, 2023.

A cross-sectional explanatory mixed-methods approach was used.

The study was carried out at Debre Markos Comprehensive Specialized Hospital between 1 March and 30 April 2023.

A total of 340 participants were included in the study, comprising 194 males and 146 females from various ethnic backgrounds. All participants scheduled for elective surgical procedures were selected using a simple random sampling method. Those with missing key information, such as operation or cancellation dates, were excluded from the study.

The primary outcome was the status of elective surgery, whether it was cancelled or conducted. The secondary outcomes focused on identifying the factors associated with elective surgery cancellations.

Elective surgery cancellations accounted for 24.40% of the scheduled procedures. Significant factors associated with cancellation included residing in a rural area (rural area (AOR)=2.47; 95% CI: 1.19 to 5.11), overscheduling (AOR=6.85; 95% CI: 2.27 to 20.63), lack of health insurance (AOR=8.68; 95% CI: 2.18 to 34.61), unstable medical conditions (AOR=9.99; 95% CI: 2.57 to 38.92), absence of a recovery bed (AOR=14.91; 95% CI: 5.10 to 43.59) and missing preoperative laboratory orders (AOR=18.16; 95% CI: 5.22 to 63.11).

A substantial number of elective surgeries were cancelled on the day they were scheduled. Key contributing factors included patients’ medical conditions, health insurance status, place of residence, availability of preoperative laboratory tests, overscheduling and lack of recovery beds. To reduce cancellations, healthcare stakeholders should enhance preoperative assessments, schedule procedures based on estimated surgical duration and ensure the availability of essential operating room resources.

Living with epilepsy, especially drug-resistant epilepsy (DRE), imposes several challenges for people diagnosed with the condition. These challenges include the physical and mental implications of epilepsy on both caregivers and patients with epilepsy. For the more than 120 000 individuals living with this neurological disorder in the Netherlands, along with their families, daily activities become hazardous, limited and costly, significantly affecting their health-related quality of life (HRQoL). As data on the burden of epilepsy in the Netherlands are lacking, studies attempting to capture the impact of epilepsy on individuals, caregivers and society are needed to enhance understanding and help address the burden of epileptic seizures.

The study is part of the AIM@EPILEPSY project. The project aims to develop a planning suite enabling cost-saving, minimally invasive treatment for epilepsy. By surveying 330 people with epilepsy and an anticipated sample of 150–200 informal caregivers across the Netherlands, using standardised questionnaires focusing on associated societal costs and the impact on HRQoL, this bottom-up, prevalence-based prospective study aims to understand the societal burden of DRE in the Netherlands. The data will be collected at 0, 3, 6 and 12 months of follow-up. The study results will describe the economic impact of epilepsy, focusing on cost-of-illness () and HRQoL (utilities) in the Netherlands.

The proposed study was approved by the Maastricht University Medical Ethics Review Committee (Approval reference: FHML-REC/2024/067/Amendment/2024_16). The result of the study is planned to be published in a peer-reviewed journal and presented at international and local scientific conferences.

To explore neonatal survival by type of neonatal complications at birth and referral pattern for these complications by place of delivery.

Bihar, India.

Women aged 15–49 years who had given live birth between July 2020 and June 2021.

Prevalence of neonatal complications at birth, referral pattern by complication and neonatal deaths by type of complication.

Data were available for 6767 (81.8%) newborns including 717 neonatal deaths. The prevalence of at least one neonatal complication at birth was reported for 32.9% (95% CI 32.4 to 33.4) newborns, with the most common complications including difficulty in breathing (21.9%), high fever (20.7%), low birth weight (12.5%) and jaundice (13.2%). A total of 578 (26.6%; 95% CI 25.8 to 27.4) neonates with complications at birth were referred to another health provider, predominantly to private sector (68.1%, 93% and 78.7% from public facility, private facility and home). The complications with high referrals included meconium aspiration syndrome (64.1%; 95% CI: 61.1 to 67.1), inability to pass urine (54.7%; 95% CI: 42.1 to 67.2), difficulty in suckling (49.7%; 95% CI: 46.9 to 52.5), cold to touch (48.5%; 95% CI: 43.5 to 53.6), inability to cry (47.2%; 95% CI: 44.2 to 50.1), pneumonia (45.6%; 95% CI: 42.0 to 49.1), difficulty in breathing (44.0%; 95% CI: 42.5 to 45.6) and lethargy (43.5%; 95% CI: 38.4 to 48.6). Referrals were linked to higher neonatal deaths, in particular, among neonates born at home and referred for complications (84.7%; p

With one-third of the neonates reported to have complications at birth and those referred more likely to die, critical gaps in addressing neonatal complications at birth and improvement in the referral services are urgently needed to reduce neonatal mortality.

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

To assess the impact of opening a large community-based asynchronous review ophthalmic clinic on attendance delays among patients with stable chronic eye disease attending a London teaching eye hospital network.

Interrupted time-series analysis of routine electronic health records of appointment attendances.

A large eye hospital network with facilities across London, UK, between June 2018 and April 2023.

We analysed 69 257 attendances from 39 357 patients, with glaucoma and medical retina accounting for 62% (n=42 982) and 38% (n=26 275) of visits, respectively. Patients over 65 made up 54% (n=37 824) of attendances, while 53% (n=37 014) were from the more deprived half of the population, and 51% (n=35 048) were males.

An asynchronous review clinic opened in a shopping centre in London, in autumn 2021, following the COVID-19 lockdown in spring 2020.

Average attendance delays (days), calculated as the difference between follow-up attendance date and the latest clinically appropriate date determined at the preceding attendance.

Pre-COVID-19, attendance delays for chronic eye disease monitoring were increasing by 0.9 days per week (95% CI, 0.8 to 0.9) on average, worsening to 2.0 days per week (95% CI, 2.0 to 2.0) after the first COVID-19 national lockdown, mid-March 2020. Opening the asynchronous review clinic increased appointment capacity, with delays decreasing on average by 8.1 days per week (95% CI, 8.1 to 8.2) shortly after opening. The rate of decrease slowed to 0.3 days per week (95% CI, 0.3 to 0.3) after 5 months. We found no significant differences in average attendance delays by age, gender or level of deprivation.

The asynchronous review clinic significantly reduced attendance delays across the hospital network, addressing pre-existing backlog for stable chronic eye diseases. The reduction appeared to be maintained after the initial backlog had been cleared.