Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.

This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.

The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.

NCT06936657.

The suicide risk among discharged psychiatric patients is substantially higher than that among patients with physical diseases and the general population. In China, few cohort studies have investigated suicidal acts in patients discharged from psychiatric facilities, and the factors that convey the risk of post-discharge suicidal acts in this specific population remain unclear. Therefore, we are conducting a prospective multicentre cohort study to investigate the association between suicide attempt history and disease severity in patients with common psychiatric disorders with post-discharge suicidal acts.

This study will recruit 3000 inpatients with one of three common psychiatric disorders, namely schizophrenia, bipolar disorder and major depressive disorder, from three hospitals in North China: Beijing Huilongguan Hospital, Tianjin Anding Hospital and the First Hospital of Shanxi Medical University. Participants will include 1500 inpatients with schizophrenia, 900 inpatients with major depressive disorder and 600 inpatients with bipolar disorder. The baseline assessment includes determining whether each recruited patient meets the diagnostic criteria for schizophrenia, major depressive disorder or bipolar disorder using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) and obtaining details on prior histories of suicide attempts and the severity of the diagnosed disorders using several questionnaires. A 2-year follow-up will be conducted after the recruited patients have been completely assessed. Follow-ups are scheduled at 3, 6, 12 and 24 months after discharge. The primary outcomes are suicidal acts, including suicide attempts and death, that occurred during the follow-up period. A survival analysis will be performed to test for the supposed associations.

This study was approved by the institutional review boards of Beijing Huilongguan Hospital (2022-67-Science), Tianjin Anding Hospital (2022-47) and First Hospital of Shanxi Medical University (2022-K155). All participants will be required to provide written informed consent before the baseline assessment. The recruitment methods will be explained to potential participants, and their confidentiality will be protected throughout the study. The findings of this study will be disseminated to peer-reviewed scientific journals and conference presentations.

ChiCTR2200064610.

Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient’s Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients’ experiences with using the PASC.

An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial’s intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.

Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.

The PASC enhanced patients’ involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.

NCT03105713.

Squamous cell carcinoma and multiple actinic keratoses caused by solar ultraviolet radiation (UVR) are among the most frequently recognised occupational diseases in Germany. Employees who regularly work outdoors, for example, in the construction industry, agriculture, forestry and gardening, are at a higher risk of developing occupational skin cancer. However, sun-safety behaviour in outdoor workers is currently insufficient. Therefore, this study aims to investigate the effectiveness of an intervention to increase sunscreen use among outdoor workers.

In this non-randomised, controlled intervention study, 234 outdoor workers from different companies in industries with outdoor working activities based in Germany will be included. The study population, aged 18 years and above, has to be intensively exposed to solar UVR of regularly 1 hour or more per day. The intervention group will receive a sunscreen package as well as health education. The control group follows the practice in their companies (‘treatment-as-usual’). At the beginning of the study, after 3 months and at the end of the study (after 6 months), both groups filled in different questionnaires. In addition, stratum corneum (SC) samples will be collected at the beginning and after 3 months. The primary outcome—increase in the frequency of sunscreen use during work and in leisure time—will be assessed from data on self-reported sunscreen use. The secondary outcomes include sun protection behaviour, knowledge about sun protection and skin cancer, and acceptance of the provided sunscreens. Further secondary outcomes include internal UV dose and UV-related immune response, determined by the levels of SC biomarkers. Data will be analysed using both descriptive and inferential methods.

The study protocol followed the principles of the Declaration of Helsinki (2013) and was approved by the Ethics Committee of Osnabrück University, Germany (reference Ethik-37/2024). Study results will be disseminated through peer-reviewed publications and conference presentations.

DRKS00035178.

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

Spiritual care has been shown to assist patients in managing anxiety, fear of death and existential concerns commonly encountered during the preoperative period. Nevertheless, surgical clinics often fail to prioritise this dimension of care. Accordingly, it is essential to gain a thorough understanding of how surgical nurses perceive and implement spiritual care. This study aims to describe the views of nurses working in surgical units regarding the provision of spiritual care in the preoperative phase, the challenges they encounter and the factors that influence this process.

A qualitative descriptive study using an inductive thematic analysis approach.

The study was conducted in the general surgery units of a tertiary-level hospital providing healthcare services to a diverse patient population, with the aim of enhancing nurses’ views related to spiritual care.

18 nurses with a minimum of 6 months of experience in surgical units were selected using purposive sampling. Head nurses and those on leave during the data collection period were excluded from participation.

Semi-structured interviews were conducted via video conferencing or telephone between September and October 2023, each lasting between 45 and 60 min. Audio-recorded interviews were transcribed verbatim and analysed using Braun and Clarke’s six-step thematic analysis method. Data collection ceased at the point of thematic saturation.

Three key themes emerged: (1) perceptions of spirituality—nurses viewed spirituality as abstract and subjective, yet recognised religious rituals as visible signs of patients’ emotional and spiritual needs. (2) Spiritual care in nursing—though seen as vital to holistic care, spiritual support was limited by privacy concerns and unclear professional boundaries. (3) Dynamics of spiritual care—delivery was shaped by institutional barriers, nurses’ personal traits and patients’ non-verbal communication of distress.

This study revealed the views of general surgical nurses regarding spiritual care. The findings indicate that while nurses acknowledge the importance of spiritual care, they encounter obstacles in its implementation. Consequently, the results suggest that nurses need to be culturally sensitive and receive institutional support—particularly in collectivist and high-context cultures such as Turkey—in order to better understand and meet spiritual needs. Future studies should explore spiritual care models adapted to different cultural contexts.

This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Qualitative focus groups; thematic analysis.

Focus group discussion with healthy older adults hosted at a university in central London.

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.

Traumatic brain injury (TBI) remains a major public health concern in India, with high mortality and long-term disability. Existing prognostic models, mostly developed in high-income countries using traditional methods, lack generalisability to the Indian context and do not use the potential of machine learning or multicentric data. This study primarily aims to develop, compare and validate machine learning methods, including the traditional approach, to predict 30-day mortality and 6-month functional outcomes in patients with moderate or severe TBI. A secondary objective is to describe and compare admission characteristics and outcomes (at discharge, 3 months, 6 months and 1 year) in TBI patients in tertiary care settings using descriptive analyses.

Data from the neurotrauma registry at Jai Prakash Narayan Apex Trauma Centre, department of neurosurgery, All India Institute of Medical Sciences (AIIMS), New Delhi, including patients admitted between 23 March 2022 and 22 September 2024, will be used for model development and internal validation. For external validation, retrospectively collected data from the same centre (May 2010 to August 2013) and prospectively collected data from AIIMS Patna (1 June 2022 to 30 November 2024) and Rajiv Gandhi Government General Hospital, Madras Medical College (MMC), Chennai (1 May 2022 to 31 October 2024) will be included. Prediction models for 30-day mortality and 6-month functional outcomes will be developed using both machine learning and traditional statistical techniques. Model performance will be evaluated based on discrimination, calibration and clinical utility, with the latter assessed through decision curve analysis (DCA). An online risk calculator will be developed based on the best-performing model to estimate outcome probabilities along with 95% CIs.

The institutional Ethics Review Board of respective data collection centres, that is, AIIMS, New Delhi, AIIMS, Patna, and MMC, Chennai, approved the study. Findings will be published in peer-reviewed journals and disseminated at national and international conferences.

This study will develop and validate prognostic models using traditional and machine learning methods tailored to the Indian TBI context. Multicentric, prospectively collected data will enhance generalisability, while clinical utility will be evaluated through DCA. Adherence to Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis + Artificial Intelligence (TRIPOD+AI) guidelines ensures methodological transparency. With external validation, these models may improve clinical decision-making, resource planning and patient-family communication in diverse Indian healthcare settings.

Older adults are particularly vulnerable to climate-related stressors such as extreme heat, food and water insecurity and displacement, all of which can worsen existing health conditions. This is further compounded by age-related physiological changes, pre-existing health conditions and social factors like isolation and limited mobility. With a growing population of older adults in low-income and middle-income countries, their vulnerability to climate change becomes a critical global public health issue and yet is understudied and needs urgent and comprehensive action. This study aims to investigate how climate seasonality impacts the health, well-being and socioeconomic conditions of older adults in rural communities of Kenya.

This formative qualitative study will use a combination of 40 in-depth interviews with older adults and key informant interviews with 20 health workers and 12 policy-makers to provide a comprehensive understanding of the impacts of climate seasonality on the health, well-being and socioeconomic conditions of older adults in rural communities of Busia and Kilifi Counties in Kenya. These counties were selected for the study due to their history of significant flooding and heat stress events. Study participants will be purposively selected for the interviews. A thematic approach will be employed in data analysis using NVivo V.14 software.

This study received ethical approval from the Medical College of Wisconsin Institutional Review Board, Institutional Scientific Ethics Review Committee at Africa International University and National Commission for Science, Technology and Innovation, Kenya. The study outputs will reflect the views and experiences of older adults, health workers and policy-makers. The findings will be disseminated to the scientific community through conferences and peer-reviewed publications and to the older adults, health workers, communities and policy-makers through videos and dissemination meetings, and policy briefs. The findings will deepen understanding of how climate seasonality is experienced by older people and shape strategies for resilience and adaptation.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

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.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

Oliceridine is a novel μ-opioid receptor selective agonist that provides analgesia while reducing μ-receptor-mediated adverse effects such as postoperative nausea and vomiting (PONV). Evidence in abdominal surgery remains limited. This study aims to determine whether oliceridine reduces PONV and improves recovery in abdominal surgery.

This is a prospective, multicentre, two-arm, randomised trial. Participants aged 18–65 years, with American Society of Anesthesiologists physical status I–III and a body mass index of 18.5–23.9 kg/m², undergoing elective major abdominal surgery, will be eligible for inclusion. Gynaecological surgeries are excluded. All patients must require postoperative intravenous patient-controlled analgesia (PCIA) and give written consent. 494 participants will be randomised to oliceridine group or sufentanil group. The primary outcome is the incidence of PONV within 48 hours postsurgery. Secondary outcomes include vomiting frequency, nausea severity score, use of rescue antiemetics, resting numerical rating scale (NRS) pain score, Quality of Recovery-15 (QoR-15) score, time to first postoperative flatus, intensive care unit (ICU) length of stay (LOS), hospital LOS and PCIA metrics (effective attempts and total volume used). Safety outcomes include other opioid-related adverse effects (ORAEs) (eg, respiratory depression, pruritus, dizziness, headache), complications related to PONV (eg, electrolyte disturbances, wound dehiscence) and other perioperative complications.

This protocol was approved (Version V3.0, 2025-01-14) by the Ethics Committee of Changhai Hospital (CHEC-2025–069), the Shanghai Public Health Clinical Centre (2025-S024-01) and the Wusong Central Hospital of Baoshan District, Shanghai (2025-17-01). It complies with the Declaration of Helsinki. Results will be shared via conferences and peer-reviewed journals.

Chinese Clinical Trial Registry (ID: ChiCTR2400089262).

Postoperative pain is particularly pronounced in spinal surgery. Inadequate management of acute postoperative pain not only reduces patient satisfaction and delays recovery but also increases the risk of developing chronic pain. Local infiltration analgesia (LIA) is a widely used technique for perioperative pain management. However, even with the use of long-acting local anaesthetics, such as ropivacaine, postoperative analgesia often remains insufficient. Preliminary evidence suggests that combining diprospan, a mixture of betamethasone disodium phosphate and betamethasone dipropionate, with ropivacaine can significantly reduce analgesic requirements in the immediate postoperative period. However, concerns about steroid-related complications, including hyperglycaemia and surgical site infections, highlight the need to identify the minimum diprospan concentration to achieve a balance between efficacy and safety. This randomised, controlled, evaluator-blinded trial aims to investigate the dose-response relationship of diprospan as an adjunct to ropivacaine for LIA in spinal surgery to determine the minimum effective dose for effective and safe pain management.

This is a single-centre, randomised, evaluator-blinded, controlled, dose-mapping study in which subjects will be randomised in a 1:1:1:1:1 ratio to the control group or to receive diprospan at concentrations of 0.003%, 0.006%, 0.009% or 0.012%. Patients will receive either 0.5% ropivacaine alone or a corresponding dose of diprospan combined with 0.5% ropivacaine for LIA. All participants will be followed for a duration of 3 months. The primary outcome measure will be cumulative sufentanil consumption within the first 48 hours postsurgery. Secondary outcomes will include additional assessments of analgesia, steroid-related adverse events and other complications within the 3-month follow-up period.

This study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital (KY2024-365-02-1). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal.

NCT06785350.

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Observational study based on prospectively collected registry data analysed retrospectively.

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Anxiety and depression are among the top contributors to disability in the Kingdom of Saudi Arabia (KSA), but little is known about their economic impact. This study estimates the economic burden of moderate to severe symptoms of anxiety and depression among adults in KSA.

A cross-sectional survey was administered via a web panel. Participants were asked to fill out the Patient Health Questionnaire-4 (PHQ-4) for themselves and on behalf of other household members to capture prevalence rates. Those who reported at least moderate symptoms of anxiety or depression filled out a longer survey with questions on healthcare utilisation and productivity losses due to symptoms. These responses were monetised using prevalence rates and population estimates to calculate per-person and total annual costs.

Prevalence estimates are based on responses from 1164 participants on behalf of 3202 Saudi adults. Of these, 269 individuals with symptoms completed the longer survey.

Prevalence of anxiety and depression; healthcare utilisation (medications, outpatient, inpatient) and productivity losses due to absenteeism and presenteeism.

In total, 26.2% reported at least moderate symptoms consistent with anxiety and/or depression. Among those with symptoms, direct healthcare costs due to anxiety and depression averaged Saudi riyal (SAR) 3431.95 per person annually. Indirect costs via absenteeism and presenteeism averaged SAR 9702.87 and SAR 24 577.28 per person assuming that anxiety and/or depression episodes last for 6 months. Summing up the healthcare costs and productivity losses yields a total annual economic burden of SAR 163.3 billion. Absenteeism accounts for 24.8% of this total (SAR 40.5 billion), presenteeism accounts for 62.8% (SAR 102.5 billion) and healthcare resource utilisation accounts for 12.4%(SAR 20.3 billion).

The overall prevalence of anxiety and depression in KSA is estimated at 26.2%. The economic burden associated with these symptoms amounts to SAR 163.3 billion or 4.1% of GDP. Absenteeism and presenteeism costs account for the vast majority of the total, but a large percentage (nearly 60%) also report emergency department visits and unplanned hospital admissions. Evidence-based interventions should be considered to address the health and economic burden of these conditions in KSA.

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease. Diagnostic delay severely impairs patient access to ALS multidisciplinary clinics, available disease-modifying medications and therapies that may prolong survival.

To investigate how patient and physician perspectives might be leveraged to promote timely ALS diagnosis, and how system-level barriers might be addressed to promote appropriate referral to ALS multidisciplinary care.

A qualitative study in Alberta, Canada, used human-centred design and interviews to map the diagnostic journeys of ALS patients and identify individual-level and system-level diagnostic barriers and opportunities.

30 semistructured interviews (10 patients; 20 physicians) were conducted. Data were inductively analysed with the aid of Miro board software. Patient and physician data were triangulated to identify key phases of the journey from symptom onset to confirmed ALS diagnosis and themes related to the diagnostic barriers and opportunities. Journey maps were created to visualise the diagnostic journey.

Patient journeys were comprised of five phases and commonly involved iterative cycles of referral and testing before an ALS diagnosis was confirmed. Four primary themes related to diagnostic barriers: difficulty recognising and responding effectively to early-stage ALS symptoms, absence of a single definitive diagnostic test, long wait times between referrals and clinical visits, and physician reluctance to pronounce an ALS diagnosis. Analysis indicated three approaches for improving diagnostic processes: increase ALS awareness; improve communication between referring physicians and physicians receiving referrals (consultants); and develop physician, diagnostic testing and multidisciplinary clinic referral forms that will guide symptom assessment and accurate referral.

Timely ALS diagnosis is challenging for patients navigating the frequently prolonged, circuitous diagnostic journey and physicians who struggle with referral pathways and the efficient diagnosis of this rare disease. Findings demonstrate the importance of increased ALS awareness and effective communication and response within referral pathways. Recommendations include strengthening the clinical approach of community-based physicians and supporting access and referral pathways. Current initiatives arising from this investigation seek to achieve meaningful change in timely referrals for progressive neurological diseases like ALS.

Type 2 diabetes mellitus (T2DM) is a chronic non-communicable disease that requires long-term management to maintain blood glucose levels and prevent complications. Smart healthcare technologies have shown promising potential in enhancing self-management and treatment adherence among people with T2DM. However, current research on the use of smart healthcare in the continuum of care for T2DM showed considerable variation in intervention approaches, content and evaluation metrics, resulting in substantial heterogeneity across studies.

This scoping review aims to identify recurring intervention strategies, summarise commonly reported components and outline outcome indicators in the application of smart healthcare within the continuum of care for T2DM, to inform future research and practice by healthcare professionals.

This scoping review will follow the methodological framework proposed by Arksey and O’Malley. A comprehensive literature search will be conducted across PubMed (National Library of Medicine), Embase (Elsevier), Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO), Web of Science (Clarivate Analytics), the Cochrane Library (Wiley), Scopus (Elsevier), China National Knowledge Infrastructure (CNKI; China Academic Journals (CD-ROM) Electronic Publishing House), Wanfang Data (Beijing Wanfang Data Co., Ltd.), VIP Database (Chongqing VIP Information Co., Ltd.) and Chinese Biomedicine Literature Database (CBM; Chinese Academy of Medical Sciences). The search will include studies published from the inception of each database up to 25 April 2025. Two reviewers will independently screen the literature and extract data. Any disagreements will be resolved through discussion with a third reviewer. The review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.

Ethics approval is not required. Findings will be disseminated through professional networks, conference presentations and publication in a scientific journal.