There is currently a lack of noninvasive biomarkers that effectively predict the progression of IgA nephropathy. We investigated the value of urinary IL-18 in predicting the progression of IgA nephropathy and whether its combination with clinical variables improved risk prediction. A total of 136 patients with IgA nephropathy were followed up for a median of 36 months in four academic medical centers. The levels of three biomarkers, urinary IL-18, urinary KIM-1 and urinary NGAL, were measured via ELISA in patients with 136 IgA nephropathy. The progression of IgA nephropathy was defined as a > 50% decrease in the eGFR or end-stage kidney disease. Multivariate Cox regression analyses of urine biomarkers for predicting the progression of IgA nephropathy were performed, and the AUCs of the clinical prediction models were calculated. Kaplan-Meier analysis revealed that high levels (> 28.1 pg/mg of creatinine) of urinary IL-18 were associated with a significantly poor renal outcome (P < 0.01), and Cox analysis further confirmed this result. High levels of urinary IL-18 were associated with a 4.7-fold greater risk for IgA nephropathy progression in adjusted analyses. For predicting IgA nephropathy progression, urinary IL-18 yielded a C-statistic of 0.77 (95% CI, 0.67-0.86), renal injury molecule 1 yielded 0.75 (95% CI, 0.65-0.86), and uNGAL yielded 0.70 (95% CI, 0.59-0.80). Urinary IL-18 levels significantly improved the C statistic from 0.77 to 0.89, outperforming the clinical and MEST-C scores. Urinary IL-18 is a significant predictor of poor renal outcomes and improves the risk prediction of IgA nephropathy.
Pemphigus vulgaris is a rare autoimmune blistering disease characterised by recurrent mucocutaneous erosions, high symptom burden and unpredictable relapse. Current management relies mainly on pharmacological therapy and hospital-based follow-up, with limited real-time monitoring and individualised support in home-based disease management. To address these challenges, this trial aims to evaluate the effectiveness of an Intelligent Multimodal Symptom Assessment and Response System, integrating patient-reported outcomes, wearable physiological data and image-based lesion assessments, to improve symptom management and quality of life in pemphigus vulgaris patients. Primary objective is to evaluate the effectiveness of the Intelligent Multimodal Symptom Assessment and Response System in improving symptom alerting and symptom management outcomes in patients with pemphigus vulgaris. Secondary objectives are to enhance patients' self-management ability in symptom monitoring and control, to improve treatment adherence throughout the follow-up period, to promote health-related quality of life among pemphigus vulgaris patients, to assess the usability and acceptability of the system from the patients' perspective. This is a multicentre, parallel-group, randomised controlled trial. 160 participants will be randomly assigned to either the intervention group (receiving the Intelligent Multimodal Symptom Assessment and Response System) or the control group (receiving standard care). Eligible participants will be adults aged 18 years or older with a confirmed diagnosis of pemphigus vulgaris and active skin or mucosal lesions, who are able to use digital devices and provide written informed consent. Individuals with severe comorbidities, concurrent participation in other clinical trials or cognitive impairments that may interfere with study adherence will be excluded. The intervention will be delivered via a digital platform, integrating electronic patient-reported outcomes, wearable physiological data and lesion images over a 12-week follow-up period. Ethical approval was obtained from the Institutional Review Board of the School of Nursing, Fudan University (IRB 2025-07-13), the Medical Ethics Committee of the Institute of Dermatology, Chinese Academy of Medical Sciences (2025-KY-034) and the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (2025-452). Approvals were granted on 10 September, 18 July and 23 July 2025, respectively. This protocol is based on V1.0, 13 July 2025 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences. ChiCTR2500109711.
Multiple sclerosis (MS) is a common central nervous system disease among young adults worldwide and Finland is one of the high-risk MS regions in Europe. Fatigue affects around 80% of individuals with MS, with prevalence rising to 95% as the disease progresses. Fatigue significantly limits daily activities and is associated with poorer employment outcomes and reduced quality of life. The objective of this qualitative study is to explore the lived experiences of individuals with MS and conceptions of MS-related fatigue among physiotherapists. This qualitative study is part of a larger research project entitled 'Building conceptualisation and understanding of momentary fatigue and activity-related fatigability in daily life for people with multiple sclerosis' (EMA-FAMS), consisting of several studies conducted from 2024 to 2028. For this qualitative study, 10 individuals with relapsing-remitting MS will be interviewed using a phenomenological approach to collect their lived experiences of fatigue. Additionally, 15 physiotherapists with experience in MS rehabilitation will be interviewed using a phenomenographic approach to explore their conceptions of MS-related fatigue. All interviews will be conducted remotely during 2025-2026. Interview data will be analysed in two phases using interpretative phenomenological analysis (IPA) and phenomenographic analysis methods. The EMA-FAMS study project has obtained ethical approval from the Regional Medical Research Ethics Committee of the Helsinki University Hospital District (HUS/10011/2024), and all the participants will provide written consent. Findings of this study will be shared through peer-reviewed articles, at academic conferences and with public healthcare and healthcare professionals.
Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments. The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with endometriosis will be recruited from one academic tertiary and five secondary hospitals in the Netherlands. They will be randomised (1:1:1:1) among four intervention groups: standard care (SC) (SC group), SC and an AIDI (SC + AIDI group), SC and CBT (SC + CBT group), and SC, AIDI and CBT (SC + AIDI + CBT group). Women with endometriosis will visit the hospital twice during the intervention period, at the start (T0) and end (T2) of the 13-week intervention period. HC will not undergo any of the interventions and will have one hospital visit (T0). Participants will complete questionnaires regarding pain symptoms, HRQoL, physical activity level, sleep, diet quality, pain cognitions, and stress at T0 and T2. Furthermore, they are instructed to collect menstrual effluent, a vaginal swab and a faecal sample. During the study visits, peripheral blood will be drawn and scalp hair samples will be taken. The primary outcome is average pain, measured using a numerical rating scale. Secondary outcomes focus on HRQoL, inflammation, immune system characteristics, vaginal- and gut microbiome, and hair cortisol levels. These are considered to reflect potentially underlying mechanisms of the effect of both interventions on the primary outcome. Biological samples and questionnaires of women with endometriosis and HC will be compared to establish the differences in secondary outcomes. This study protocol has been approved (approval number: NL86247.091.24) by the METC Oost-Nederland from Radboud University Medical Centre on July 11, 2024. Prior to participation, participants are required to provide informed consent. The results will be widely disseminated through scientific peer-reviewed journals, and presentation to a broad audience in scientific meetings, congresses, patient meetings, as well as in policy-relevant forums. NCT06332560.
While it is common practice for academic institutions to implement a student honor code, there is not a comprehensive review of the reasons for the implementation, distinction from a code of conduct, implications for a competency-base curriculum design and exam proctoring practices, descriptions and criteria commonly included in a code, and procedural enforcement for non-compliance. This exploratory study offers a broad examination of key considerations when determining whether or not to consider creating and adopting a student honor code by examining in depth the why, what, and how for an academic health science center. A thematic analysis of existing honor codes gathered from sample academic health science centers as well as relevant literature review findings were used to identify common codes or terms for the behaviors associated with an honor code, adjudication procedures, and the body of authority who reviews and enforces the code.
Treating major depressive disorder is difficult due to the lack of objective criteria to guide therapy. Decision making often relies on trial and error, which limits treatment effectiveness. Precision psychiatry has been presented as a new approach that uses biological and multimodal data to support diagnosis and treatment, similar to precision medicine in other fields. This study aims to explore the perceptions of key experts regarding the drivers and barriers to the adoption of precision psychiatry in Latin America. Secondary objectives are to explore the conceptualization of precision psychiatry, explore its potential benefits in the context of MDD, identify potential drivers and barriers to its implementation in the region, and identify context specific considerations for future implementation. This is a qualitative study based on interviews, and a hybrid deductive-inductive content analysis was applied. A scoping review informed the development of a semi structured interview guide. Semi structured interviews were then conducted with experts involved in healthcare provision, mental health policy shaping, and academic research. The interviews explored the perceived value of precision psychiatry, its potential contribution to the treatment of major depressive disorder, and the challenges surrounding its adoption in the region. Participants viewed precision psychiatry as a promising approach to improve diagnostic accuracy, guide targeted treatment, and use healthcare resources more efficiently. These advantages were seen as particularly relevant for major depressive disorder due to its high burden, heterogeneity, and prevalence of treatment resistant cases in Latin America. Key barriers included limited understanding of precision concepts, insufficient evidence on effectiveness and cost, low provider awareness, high implementation costs, regulatory constraints, and systemic challenges such as under-resourced services, stigma, and shortages of trained professionals. Precision psychiatry has the potential to improve mental health care in Latin America according to participants, especially for major depressive disorder. Realizing this potential will require stronger evidence, greater investment in research and training, improved information systems, stronger mental health policies, and regulatory processes that can assess clinical, economic, and societal value. Coordinated efforts across stakeholders are necessary to support its development and adoption. Not applicable.
The literature on sustainability performance frameworks for healthcare organisations varies in its applicability to different types of organisations and settings, functions and activities, and definitions and dimensions of sustainability. This fragmentation creates implementation barriers which may be overcome by consolidating existing evidence in a format that can be linked directly to organisations' business models. This protocol proposes a scoping review to assess the extent of the literature on frameworks for monitoring and evaluating the multidimensional sustainability performance of healthcare organisations and to assemble a consolidated framework in an operationally relevant format to support progress towards sustainable healthcare organisations. The search strategy will be applied across Semantic Scholar, Google Scholar, Web of Science, MEDLINE, Embase, Academic Search Premier, CINAHL and Business Source Premier databases. Search results from 2009, coinciding with the publication of the WHO's 'Healthy Hospitals, Healthy Planet, Healthy People' report, will be considered. The scoping review will include studies reporting on multidimensional sustainability monitoring or evaluation frameworks applied or developed for use at the level of healthcare delivery organisations. Studies relating to operational units within organisations or to healthcare systems will be excluded. The review's context will be restricted to operational sustainability and will not consider the literature on sustainable design planning and construction of new facilities. No specific exclusion criteria will be applied to the types of healthcare delivery organisations nor participants implicated in the frameworks. Title and abstract screening against the inclusion and exclusion criteria, followed by full-text assessment of remaining articles, will be performed by two reviewers. Data from included studies will be extracted using a custom-designed extraction tool, analysed using topic or thematic analysis to consolidate themes and presented within the triple-layered business model canvas. Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.
Despite growing recognition of the critical importance of physician leadership in delivering safe healthcare, especially in light of the 2023 medical crisis and professional resistance in Korea, existing studies on leadership education have focused predominantly on countries with long-established leadership curricula. This study aims to assess the curricular content of Korean medical schools to provide a quantitative and qualitative baseline of medical leadership training in the undergraduate curriculum. We conducted a content analysis of undergraduate medical curricula from 19 Korean medical schools using the Medical Leadership Competency Framework (MLCF) as a guiding framework. Survey questionnaires were distributed to designated faculty at each institution, and 270 courses were analyzed, yielding 504 leadership-related codes that were categorized thematically across the five MLCF domains and by academic year. Our analysis revealed that 228 codes (45.2%) fell within "Demonstrating personal qualities" and 75 codes (14.8%) within "Setting direction," with predominant emphasis on medical ethics and law. Training in systems-based practice, self-awareness, emotional intelligence, and team-based approaches was relatively limited. Substantial institutional variation existed, with only eight of 19 schools offering curricula covering all five MLCF domains. Most leadership content was delivered through isolated, single- semester courses rather than longitudinally integrated programs. While Korean medical schools recognize certain leadership competencies, there is a need for more comprehensive and consistent integration of leadership development, particularly in teamwork and systems-based practice. We recommend longitudinal integration of leadership education across pre-clinical and clinical years to address evolving competencies at different training stages.
Although palliative care (PC) is recognized as a component of comprehensive care throughout the life course and universal health coverage, more than 85% of the global need for PC is unmet. Nigeria has isolated PC provision, with a narrow scope, limited availability, and inadequate support for PC services, despite having adequate legislation to support the operation in the country. Given the rising incidence of chronic illnesses that are amenable to PC in Nigeria, this study aimed to explore healthcare professionals' (HCPs') knowledge and attitudes towards PC and identify targets for improving PC delivery nationally. Using a mixed-methods convergent design, an online survey was distributed to multidisciplinary HCPs in Nigeria. The survey included validated tools that assessed knowledge and attitudes related to PC, pain management, and end-of-life (EOL) care. Five focus group discussions (FGDs) were conducted and qualitatively analyzed using rapid matrix analysis to triangulate themes with survey responses. From February to December 2024, 117 HCPs from 26 hospitals across five of six geopolitical zones of Nigeria completed the quantitative survey. Most respondents were nurses (67%) or physicians (26%), worked in public teaching hospitals (70%), and provided care for patients with cancer (94%). Over half (56%) received some PC training, though many expressed interest in additional training on pain management (65%), EOL communication skills (50%), and EOL ethics and decision-making (49%). FGDs from three geopolitical zones revealed 3 major themes: (1) HCPs have a shared high-level understanding of the goals of PC with varied perceptions around PC delivery; (2) Challenges in the practical delivery of PC include systemic barriers, opioid costs and stigma, and patient receptivity; (3) Delivering PC impacts HCPs' job satisfaction and takes a psychological toll. Participant-identified strategies for overcoming barriers to PC delivery included the development of standardized PC protocols, opioid policy changes, patient education about PC, and HCP training and support. HCPs in this study demonstrated broad interest in and knowledge about PC. However, systemic barriers and limited patient and caregiver receptivity limit PC uptake in clinical practice. Future initiatives should involve clinical training related to PC communication, community education programs, and implementation of contextually appropriate protocols and policies for PC delivery.
Poststroke depression (PSD) affects approximately 33% of stroke survivors and is associated with worse outcomes, poor quality of life (QOL) and mortality. Despite its prevalence and consequences, there is no consensus on the most effective strategy for PSD prevention. Behavioural activation (BA) is an effective intervention for depression across diverse populations and is considered safer, better tolerated and a longer-lasting alternative to antidepressant medications. This study aims to test the effectiveness of a remotely delivered BA intervention to prevent PSD (Tele-BA-S). We will conduct a randomised effectiveness trial of 350 low-income adults (≥ 55 years) within 3 months of ischaemic or haemorrhagic stroke and with subthreshold depression (Patient Health Questionnaire-9 score <9 and 24-item Hamilton Depression Rating Scale (HDRS) score <15). Eligible and consented adults will be randomly assigned to Tele-BA-S or treatment-as-usual. Tele-BA-S will be comprised of an orientation session, 5 weekly BA sessions and 2 follow-up monthly booster calls delivered by trained community health workers. We will conduct assessments at 1 month, 2 months, 4 months, 6 months and 9 months after baseline. The primary outcome (PSD) will be measured by the 24-item HDRS. Secondary outcomes will include anxiety (Generalised Anxiety Disorder-7 Scale), psychological well-being (Ryff Scale of Psychological Well-being), QOL (Stroke Specific QOL Scale), medication adherence (Medication Adherence Report Scale-5), rehabilitation adherence (Rehabilitation Adherence Inventory), number of emergency department visits and hospitalisations, functional outcome (Barthel Index) and degree of disability (Modified Rankin Scale). Mediating variables will include self-efficacy (Stroke Self-Efficacy Questionnaire), motivation (Motivation in Stroke Patients for Rehabilitation Scale) and activity engagement (Neuro-QOL Participation in Roles and Activities). Exploratory implementation measures will also be collected. Primary analysis will follow the intention-to-treat principle and evaluate intervention effects over time using mixed-effects models. Ethical approval was obtained by the University of Texas Health Science Center at Houston's (UTHealth Houston) Committee for the Protection of Human Subjects Institutional Review Board. The trial protocol, statistical analysis plan and code, and deidentified participant data will be made available via the National Institute of Mental Health Data Archive. The results will be presented at academic conferences and submitted for publication. The authors declare that they have no conflicts of interest relevant to the content of this manuscript. NCT06864715.
Care provided in people's own homes (domiciliary care) is an increasingly important part of long-term care. There are various services, including home visits, live-in care and housing with care. Some people directly employ care staff, called personal assistants. Services vary in quality, price and availability, and there is currently little evidence of the value these services provide to the public purse and individuals. This study protocol presents planned research to fill this important gap. This will be a cross-sectional study based on surveys of care recipients, their unpaid carers as well as formal care providers. In the first half of 2026, we will survey 1850 people accessing domiciliary care either through a homecare agency, a housing with care scheme or by directly employing personal assistants and 400 unpaid carers, all based in England. We will conduct a cost-effectiveness analysis taking a 'production function' approach and use quality of life as measured by the Adult Social Care Outcomes Toolkit as the main outcome of interest. The study received ethical approval from the School of Social Sciences Staff Review Committee at the University of Kent on 20 May 2025 (reference 1195) and the Health Research Authority, London-Camberwell St Giles Research Ethics Committee on 28 October 2025 (reference 25/LO/0652). Implications around consent, data protection and confidentiality, risk and participant payment are discussed. In addition to academic outputs (eg, academic articles, conference presentations), we aim to coproduce news items and blogs with people with lived experience of accessing long-term care and jointly present findings at events aimed at the care sector. Moreover, we will offer participating care providers benchmarking briefs based on our findings.
Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial. Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out. Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders. ISRCTN15570706.
Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours. This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity. This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications. NCT06505109.
The pace of surgical innovation appears ever faster. Innovation is being freed from the design constraints of the opposable digits of a surgeon's hand through the use of programmable binary digits. Surgeons must be the drivers of change and central to the application of innovations. We should collaborate with industry, engineers and scientists to think out of the box but must consider also expense, environmental impact, equity, and ethics. But we should not be blinded by shiny technology: innovation without impact is mere noise. The ultimate considerations are the diagnosis and management of surgical disease, of improving the care of our patients. Expert surgeons, scientists and engineers across the world were identified and invited to describe areas of innovation within surgery. They were given free rein to review their areas of expertise and to discuss both current and future applications of technology within surgical care. The Commission spans multiple surgical specialties and scientific domains. It reviews translational genomics, including the role of ctDNA, alongside microbiomic and proteomic applications in improving the diagnosis, treatment and monitoring of surgical disease. Applications to enhance surgical procedures are described, from medical micro/nanorobots for minimally invasive interventions, sensory-enriched surgery with visual optimization and molecular image-guidance to intelligent and semiautomated instruments. The expansion and broad influence of artificial intelligence in surgical writing, training and simulation, diagnosis and robotics is widely described. The role of surgical innovation and technology in driving personalized care for benign and malignant surgical disease from genomic profiling to bespoke surgical and non-surgical treatment pathways and surveillance is considered. The future of surgery is poised to become more precise, personalized, and effective. Collaboration with engineers, data scientists, and industry partners not only represents an exciting opportunity for surgeons to participate in team science but is critical to focus innovation goals on optimizing patient care and outcomes.
Tuberculosis (TB) remains a major global health challenge, with an estimated 10.8 million new cases and 1.25 million deaths in 2023. Despite advances in molecular detection of Mycobacterium TB (MTB), significant diagnostic gaps remain: in 2023, only 48% of newly diagnosed TB cases received rapid diagnostic testing, far below the 100% target. These challenges are intensified in high-burden settings, where sputum collection and distinguishing TB from other illnesses are difficult. The Xpert MTB Host Response (Xpert-HR) assay measures host immune gene expression from blood, shows promise but variable accuracy across studies. Hence, this study will perform an Individual Patient Data Meta-Analysis (IPDMA) to evaluate the diagnostic accuracy, subgroup performance, predictive values and clinical benefit of Xpert-HR compared with conventional sputum-based testing. This systematic review and IPDMA will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Diagnostic Test Accuracy guidelines. Prospective studies including adolescents (>12 years) or adults with presumed TB tested using the Xpert MTB Host-Response assay will be identified through PubMed, Embase and Web of Science. Study quality will be assessed using an adapted diagnostic accuracy tool. Diagnostic accuracy will be pooled using random-effects models, with subgroup analyses where applicable. Decision curve analysis will evaluate clinical utility. Predictive values will be estimated across TB prevalences of 1-10%. Both one-stage and two-stage IPDMA approaches will be explored, and the proportion of unevaluable samples will be reported. The review will be based on deidentified individual patient data to be obtained upon request from the corresponding authors of studies fulfilling all the data sharing agreement. Ethical approval has been obtained from the Ethical Committee of the Medical Faculty of Heidelberg University (Approval No. S-043/2026). The results will be disseminated through publication in a peer-reviewed journal, and through presentations at academic conferences. CRD420251071857.
Management of cryptoglandular anal fistula is characterised by wide variation in diagnostic strategies, surgical techniques and outcome reporting, limiting comparison between studies and hindering evidence-based guideline development. This study aims to implement a standardised core outcome measurement set within a large international observational framework and to evaluate the feasibility of a scalable digitally supported model for global collaborative surgical research. Cryptoglandular anal fistula treatment is a prospective, international, multicentre observational study comprising two components: a short-term audit capturing clinician-reported outcomes at 3 months and a long-term cohort capturing clinician- and patient-reported outcomes over twelve months. Adults undergoing surgery for primary or recurrent cryptoglandular anal fistula are eligible, excluding non-cryptoglandular aetiologies. Data are collected using secure electronic case report forms and digitally administered patient-reported outcome measures, with paper alternatives available where required. Outcomes are defined according to the Anal Fistula Core Outcome Measurement Set and include clinical and radiological healing, recurrence, complications, reintervention, development of additional fistulas, symptoms, psychological impact of treatment, continence, quality of life and additionally work productivity. The study was designed around a predefined nine-step framework, including multidisciplinary coordination, central ethical approval to support local submissions, artificial intelligence-assisted translation of study materials with native review and implementation of secure digital data capture systems. Based on previous European Society of Coloproctology studies and expected centre volumes, the audit arm aims to include approximately 1000 patients and the cohort arm 500 to 750 patients. Central ethical approval has been obtained from the Medical Ethics Review Committee of the Maastricht University Medical Centre+ under METC 2024-0374 (audit arm) and METC 2024-0361 (cohort arm) with local approvals or waivers secured in participating countries according to national regulations. Written informed consent is obtained for cohort participation. Results will be disseminated through peer-reviewed publications and international conferences, with the aim of informing future guideline development and supporting patient-centred care in cryptoglandular anal fistula management.
It is estimated that 30-70% of patients in psychiatry have co-existing psychiatric disorders and substance use disorders, also called dual diagnosis. This condition often results in a complex clinical condition that affects the treatment trajectory and outcomes. Although the two conditions are intertwined, they are handled in two different sectors in Denmark, and therefore mostly treated separately. To overcome this divide, a coordination model was developed, with the aim of coordinating treatment between psychiatric outpatient FACT teams and municipal substance use treatment facilities for patients with dual diagnosis. The aim of this study was to assess the barriers and facilitators to a cross-sectoral coordination model as perceived by frontline staff during implementation. 24 semi-structured interviews with frontline staff were performed in both sectors. The interview guide and analysis are based on the Consolidated Framework for Implementation Research (CFIR) in combination with Qualitative Content Analysis. During implementation of the coordination model, frontline staff perceived barriers and facilitators in outpatient psychiatry and substance use treatment centers within all domains of CFIR, yet overall, participants were positive about the benefits and potentials of the model. During implementation they experienced an improvement in coordination practices, although patients were still rejected despite use of implementation strategies aimed at knowledge and skills, staff in both sectors did not feel competent to treat the target group and called for more training and concrete action plans. The flexibility required by this target group was considered hard to attain due to a lack of time and staff resources. According to frontline staff, a sustainable effort and stronger cross-sector collaboration calls for extensive management support, an ongoing focus on culture- and behavior changes, and enhancement of competences associated with addressing, detecting, and treating dual diagnosis.
Despite limited evidence supporting the long-term effectiveness of opioid therapy and existing recommendations on multi-disciplinary treatment, patients with chronic non-cancer pain (CNCP) continue to receive opioids. In Sweden, most prescription renewals for CNCP are issued by general practitioners (GPs). To explore GPs' experiences with and understanding of opioid prescribing for CNCP and their views on multi-disciplinary collaboration. Semi-structured interviews were conducted with GPs and one GP-trainee in Region Uppsala, Sweden (February-June 2022). Topics included long-term opioid treatment (LTOT), opioid tapering, prescription renewal and multi-disciplinary collaboration. The interviews were recorded, transcribed and thematically analyzed. Twelve participants including one GP trainee with a mean experience of 13 years were involved. Two main themes were developed. (1) To endure the ethical conflicts of opioid prescribing practices, where the GPs negotiated ethical conflicts arising in the intersection between patient needs, personal values and clinical guidelines regarding LTOT. (2) The last resort, where the GP's role was conceptualized through the lens of systemic healthcare structures, perceived patient demands, expectations from fellow healthcare providers and the internal expectations held by themselves. GPs experienced moral distress prescribing opioids and reinforced stigma toward patients with CNCP and LTOT. These dynamics hinder treatment reassessment and biopsychosocial evidence-based care. Perceived expectations of GPs as the 'last resort' may perpetuate opioid use and impede collaborative care with the patient and multi-disciplinary teams. Opioid prescribing involves significant ethical dilemmas for general practitioners (GPs).General practitioners face challenges balancing opioid risks with patient expectations and work load.Tapering long-term opioid therapy (LTOT) is regarded as a time-intensive process and is often deprioritized.The identity of the GP as a comprehensive healer is challenged within the context of chronic non-cancer pain (CNCP) and opioid prescribing.General practitioners infrequently utilize multi-disciplinary approaches for the care of patients with CNCP and LTOT.
The Quality Maternal and Newborn Care Framework index (QMNCFi) is a validated English-language instrument developed to assess women's experiences during pregnancy, childbirth, and the postnatal period. These experiences include respect, dignity, communication, continuity of care, and involvement in decision-making. Despite Arabic being spoken in 22 countries, substantial variations exist in dialects, terminology, and healthcare practices. Because maternity care models, communication styles, and clinical terminology vary across Arabic-speaking contexts, ensuring semantic and experiential equivalence is essential when adapting the QMNCFi for use in Middle Eastern settings. This study aimed to translate and culturally adapt the QMNCFi into Arabic and to document the international collaborative methodological process supporting this adaptation. We followed an internationally recognized six-stage approach for translation and cultural adaptation (forward translation, synthesis, back translation, expert committee review, pre-final testing, and finalization). Two research teams, representing institutions across five countries, collaborated under a unified protocol. Cognitive interviews were conducted with 48 postpartum participants in Palestine and the Kingdom of Saudi Arabia. Refinements included adding a country identifier within demographic items to distinguish data collection sites, aligning demographic categories (e.g., education and income/currency), clarifying items with context-relevant examples, and adding "not applicable" where appropriate. These adjustments improved clarity and contextual fit without altering item order or scoring. Inter-rater agreement reached 99.1%, exceeding the a priori 80% benchmark. Operational challenges, including ethics approvals, data-sharing restrictions, supervision structures, and cross-site coordination, were addressed through structured mentorship, version-controlled documentation, and regular joint meetings. A shared language did not ensure semantic or experiential equivalence. Addressing institutional, regulatory, capacity, and linguistic factors was essential for developing a usable Arabic QMNCFi. This work provides a transparent methodological guideline for same-language, multi-country adaptation of health measurement tools and prepares the Arabic QMNCFi for psychometric validation and future implementation in Arabic-speaking maternity care settings.
Previous post-entry language assessments (PELAs) research in higher education shows that academic language proficiency contributes to academic achievement. PELAs are particularly valuable for higher education systems with minimal or no admission requirements for identifying and supporting at-risk students. However, the availability of PELAs for languages beyond English, such as Dutch, is limited. Moreover, existing Dutch PELAs and their construct validity evidence are not publicly accessible, and predictive validity analyses typically do not reach the program-specific level. Therefore, the present study introduced the Ghent University Language Screening (GULS), an easy-to-administer, free, and publicly accessible Dutch PELA. More specifically, GULS evaluates first-year students' reading comprehension in higher education. First, we confirmed the construct validity of GULS at the model and item levels and its reliability using data from the two 3-year periods 2017-2018 to 2019-2020 (N1 = 12,527) and 2020-2021 to 2022-2023 (N2 = 17,204). Second, we examined GULS's predictive validity for academic achievement (i.e., Grade Point Average and study success) on data over the same two periods across 16 bachelor study programs (n1 = 8244; n2 = 10,891), followed by predictive validity analyses for each study program across the combined 6-year period. Results demonstrate that GULS is a valid and reliable PELA for assessing Dutch language proficiency, especially for first-year higher education students who require language support to ensure equal educational opportunities. As such, GULS functions as a predictor of first-year academic achievement. We discuss the potential application of GULS in future educational research and practice given its accessibility.