Conectar
IgG4-related disease is a chronic fibroinflammatory disease with multiorgan involvement. Glucocorticoids and/or immunosuppressants as well as rituximab are both first-line treatments in remission induction therapy. However, relapse is common during the maintenance period, particularly in patients with re-elevation of serum IgG4 level. This study aims to evaluate whether adding mycophenolate mofetil (MMF) during the maintenance phase for such patients can reduce the risk of disease flare.
This study is a multicentre, randomised, double-blind, placebo-controlled study. A total of 108 eligible patients with re-elevation of serum IgG4 level during maintenance therapy will be included in this study and randomised in a 1:1 ratio to receive add-on MMF 0.5 g one time per day or placebo for 52 weeks. The primary outcome is the proportion of patients experiencing relapse at week 52. Secondary outcomes include time-to-relapse, changes in disease activity and serum IgG4 level, stratified relapse rate according to the elevation level of IgG4. Analyses will follow the intention-to-treat principle.
The study has been approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (approval no. K3231). Written informed consent will be obtained from all participants before enrolment. Findings will be disseminated through peer-reviewed journals and conference presentations.
Artificial intelligence-based conversational agents (CAs) have shown transformative potential in healthcare, yet their application in cancer health education has remained underexplored, particularly regarding usability and patients' experiences. Existing reviews lack a dedicated focus on user perspectives, limiting insights into how CAs can be optimised for patient needs.
To explore the usability and experience of artificial intelligence-based conversational agents in health education for cancer from the user perspective.
A scoping review was conducted with the Joanna Briggs Institute Scoping Reviews conduct guidance and reported according to the preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews checklist.
A search was performed in PubMed, Embase, CINAHL, Web of Science, PsycINFO, IEEE Xplore Digital Library and ACM Digital Library from their inception to March 6, 2024. The references to the articles included were also searched. The Pillar Integration Process was employed to chart data.
A total of 12 studies were included in this scoping review, which revealed that CAs supported diverse educational contexts, including cancer-related knowledge (41.7%), pretest genetics (33.3%), self-management (16.7%) and psychological skills (8.3%). Three studies reported that patients preferred interactions with multiple options or ‘read more’ functions. Patients were generally optimistic about the CAs and reported that CAs provided informational, physical, and psychological support for them. However, limitations such as insufficient customisation, lack of empathy, and defects in understanding free-input questions were noted.
This review demonstrated that CAs are promising complementary tools in cancer education, alleviating healthcare burdens while enhancing patient engagement, which was particularly critical in resource-limited settings. However, clinical implementation requires more rigorous validation of safety protocols and high-quality original studies.
Nurses and policymakers should consider CAs valuable tools to enhance cancer health education, provided that they align with patient needs and institutional safety standards.
Ample evidence has shown the benefit of high-fidelity simulation (HFS) in promoting learning in pre-licensure nursing students, but the evidence for practising registered nurses has not been synthesised.
To evaluate the effects of HFS training on learning outcomes and satisfaction in practising registered nurses.
In this systematic review and meta-analysis, we searched PubMed, CINAHL, ERIC, Cochrane Library, Web of Science and China National Knowledge Infrastructure (CNKI) for studies published in English or Chinese from database inception to 31 May 2023 (updated on 20 April 2025). All randomised controlled trials (RCT) or quasi-experiments that compared HFS training with traditional methods (e.g., lecture) for practising registered nurses and reported learning outcomes and satisfaction were included. Risk of bias was assessed by the Cochrane risk-of-bias tool for randomised trials (RoB 2) and non-randomised trials (ROBINS-I). Inverse-variance random-effect models were used to calculate standardised mean differences (SMDs) with 95% confidence interval (CI). We followed the PRISMA 2020 guideline.
Of 1404 records, eight eligible studies (five RCTs and three quasi-experiments) involving 275 practising nurses were identified. Two RCTs had high risk of bias, while others showed some concerns or moderate risk of bias. Meta-analyses showed that HFS could promote knowledge acquisition (SMD = 0.65, 95% CI, [0.35, 0.95], p < 0.01, I2 = 0%), professional skills (SMD = 0.72, 95% CI, [0.41, 1.04], p < 0.01, I2 = 0%) and learning satisfaction (SMD = 1.24, 95% CI, [0.35, 2.13], p < 0.01; I2 = 67%), compared with traditional methods. The pooled effect on self-confidence was marginally insignificant (SMD = 0.59, 95% CI, [−0.04, 1.22], p = 0.07; I2 = 67%).
Compared with traditional training methods, HFS is effective in promoting knowledge acquisition, professional skills and learning satisfaction and may enhance self-confidence among practising nurses. To strengthen the evidence base, more rigorous RCTs with larger sample sizes, adequate reporting of HFS design, and standardised outcome measures are warranted.
PROSPERO (CRD42022358717). No Patient or Public Contribution.
To summarize the current evidence on reducing loneliness among informal caregivers of people with dementia, such as family members or friends.
A systematic review.
The methodological quality was evaluated using the revised Cochrane risk-of-bias tool for randomized controlled trials and the revised JBI critical appraisal checklist for quasi-experimental studies. Data were extracted as predefined and synthesized narratively. The Template for Intervention Description and Replication checklist was used to report the intervention characteristics.
Six electronic databases (MEDLINE via PubMed, EMBASE, Cochrane Library, PsycINFO, CINAHL Plus, and Web of Science Core Collection) were searched for studies published in peer-reviewed English journals from the inception of each database until 28 January 2024.
Eight studies were included in this review, published between 2002 and 2023, with three being randomized controlled trials. All included interventions were psychosocial. Only one study reported significant improvements in loneliness. Five studies utilized remote and online interventions, such as social networking, psychotherapy, and online social support. Interventions varied in their impact on secondary outcomes, including stress, depressive symptoms, anxiety, and caregiver burden. Four studies demonstrated a positive effect on caregiver stress levels. One pilot trial reported a positive impact on depressive symptoms, and another study noted potential improvements in anxiety. One pilot study reported an average improvement in caregiver burden.
While the evidence is insufficient for conclusive statements, this systematic review suggests potential benefits of interventions to reduce loneliness and improve mental health among these caregivers. It highlights the promise of remote interventions in addressing loneliness among dementia caregivers.
The findings suggest that tailored interventions, especially those delivered remotely, can enhance the support provided to caregivers, potentially improving their mental health and overall well-being.
This systematic review adhered to the PRISMA statement.
No patient or public contribution.
by Dandan Liu, Huixia Ji, Ye Chen, Tongzhou Zhou
BackgroundMetabolic dysfunction‑associated steatotic liver disease (MASLD) is a multisystem metabolic disorder. The impact of occupational noise exposure on metabolic processes through non-auditory pathways is also closely associated with hepatic steatosis in addition to obesity. Most studies examine noise exposure or Body Mass Index (BMI) alone on ultrasound-detected hepatic steatosis(UDHS), while few examine BMI’s interaction with occupational noise duration. The underlying mechanisms of these combined effects remain unclear. The correlation between occupational noise exposure duration and UDHS in automotive manufacturing workers is examined, as well as the interactive role of BMI
ObjectiveThis study investigates the correlation between occupational noise exposure duration and UDHS in automotive manufacturing workers, as well as the interactive moderating effect of BMI on this association.
MethodsA retrospective study involved 769 male workers exposed to occupational noise. Ultrasound was used to diagnose hepatic steatosis. Modified Poisson regression with robust variance estimation was used to analyze variable associations. A slope analysis and Johnson-Neyman test were used to validate BMI and variable interactions. A sensitivity analysis was performed to ensure robustness.
ResultsOverall, 53.2% of workers had UDHS. Noise exposure duration showed a significant independent association with UDHS,with a negative interaction effect on BMI (P = 0.006) after adjusting for confounding factors. In normal-weight workers, each additional year of noise exposure was associated with an 8.2% higher UDHS likelihood (P < 0.001), but not statistically significant in overweight/obese individuals; BMI = 27.7 kg/m² represented the critical threshold where the magnitude of this association approached zero. Alcohol consumption and overweight/obesity were independent risk factors.
ConclusionNoise exposure is associated with UDHS risk among male workers, yet BMI modifies this association, whereby the magnitude of this association weakens as BMI increases. These findings are specific to male factory workers and cannot be generalized to female populations. Accordingly, tailored occupational health protection strategies can be developed for noise-exposed populations.
Operating room noise levels during ankle fracture open reduction and internal fixation (ORIF) can reach levels well above the WHO recommended 35 dB(A) threshold for hospital treatment rooms. Neuroimaging evidence confirms that primary auditory cortex remains responsive to acoustic stimuli even under general anaesthesia (bispectral index 40–60), suggesting intraoperative noise may trigger stress responses via subcortical pathways. Active noise-cancelling (ANC) headphones combined with music therapy represent a promising non-pharmacological intervention for enhanced recovery after surgery protocols, yet no study has employed factorial design to isolate the independent and interactive effects of noise reduction and music therapy on postoperative recovery.
This prospective, randomised, participant and outcome-assessor-blinded, four-arm, 2x2 factorial design trial will enrol 224 adult patients (aged 18–65 years) scheduled for elective ankle fracture ORIF under standardised anaesthesia combining saphenous nerve block with popliteal sciatic nerve block plus general anaesthesia at Deyang Sixth People’s Hospital, Sichuan, China. Patients will be randomised 1:1:1:1 to: (1) NC-MT group: ANC plus personalised music; (2) NC group: ANC only; (3) MT group: passive isolation plus personalised music and (4) Sham group: passive isolation only. All groups will wear identical Soundcore Space One headphones, applied after anaesthesia induction (loss of consciousness) and removed before emergence (Bispectral Index<60), so that patients cannot perceive between-group difference in device operating mode. The primary outcome is the 15-item Quality of Recovery score (QoR-15) at 24 hours postoperatively. Secondary outcomes include pain (Visual Analogue Scale), anxiety (6-item State-Trait Anxiety Inventory), sleep quality (Richards-Campbell Sleep Questionnaire), melody recognition test, opioid consumption and adverse events.
This study was approved by the Institutional Review Board of Deyang Sixth People’s Hospital, Sichuan, China, on 23 December 2025 (DSLYIRB-2025-11) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice of the International Council for Harmonisation (ICH-GCP) guidelines. Written informed consent will be obtained from all participants prior to enrolment. Findings will be disseminated through peer-reviewed publication and academic conference presentations.
ChiCTR2600123100.
by Tian-Qi Li, Qin Zhang, Hui-Juan Wang, Zhao-Feng Ma, Bing-Yu Lu, Ke-Gui Hou, Xiang-Yu Zhang
ObjectiveTo detect and analyze the correlation between commonly mutated genes and known genes associated with tooth agenesis in patients with non-syndromic tooth agenesis. The aim is to explore new genes that may be associated with tooth agenesis, to provide a genetic reference for its prevention as well as for the clinical diagnosis and treatment of tooth agenesis.
MethodsGenomic DNA was extracted from the peripheral blood of 18 congenitally edentulous subjects, and related gene mutations were identified by whole-exome sequencing. The genes related to maxillofacial development and the known pathogenic gene sequences of congenital tooth agenesis were selected for local alignment analysis of pairwise sequences, and the metric relationship of related sequences was determined. Hierarchical and fuzzy clustering methods were used for cluster analysis.
ResultsHierarchical clustering and fuzzy clusterings yielded consistent results. The EPB41L4A gene clustered with a large number of well-known and well-defined genes associated with tooth agenesis. From the perspective of cluster analysis, it can be inferred that the genes clustered together generally have similar functions.
ConclusionEPB41L4A, which is involved in the Wnt pathway, may be a candidate gene warranting further investigation.
by Belal Elmarhoumy, Mahmoud Salloum, Thamir Bahattab, Hussein Alhelaly, Mohammed Sghaireen, Matheel AL-Rawas, Johari Yap Abdullah, A. S. M. Rafiul Haque, Mohammed Mousa
The present study evaluated the influence of 3% and 10% (by weight) silicon dioxide (SiO2) and titanium dioxide (TiO2) nanoparticles (NPs) on the tear strength, tensile strength, and elongation at break of a room-temperature vulcanizing (RTV) maxillofacial silicone elastomer (MFSE; A-2000) after two years of natural tropical weathering. A total of 160 specimens (80 dumbbell-shaped and 80 trouser-shaped) were allocated to non-weathered and weathered groups, each divided into five subgroups (n = 8): unfilled control, 3% SiO2, 10% SiO2, 3% TiO2, and 10% TiO2. Weathered specimens were exposed outdoors in a hot, humid tropical climate for two years. Mechanical properties were measured using a universal testing machine. Data were analyzed using two-way ANOVA followed by Tukey HSD post-hoc tests (α = 0.05). In non-weathered specimens, 3% SiO2 increased tear strength by 34% (17.89 ± 0.31 vs. 13.38 ± 1.07 N/mm; P < 0.001) and tensile strength by 35% (4.28 ± 0.27 vs. 3.16 ± 0.13 MPa; P < 0.001) compared with the unfilled control. After natural tropical weathering, only the 3% SiO2 group maintained a significantly higher tear strength (14.03 ± 2.10 N/mm) than the unfilled group (11.09 ± 1.53 N/mm; P = 0.007). Weathering significantly reduced tear strength in all NP-filled groups (P < 0.001) but increased tensile strength across all groups (P < 0.01), with the smallest increase observed in the 10% TiO2 group (+10.1%; P = 0.004). Elongation at break decreased significantly in all groups following weathering (P < 0.001); however, NP-filled groups retained substantially higher elongation values (losses of 13.1–17.6%) than the unfilled control (loss of 51.1%). In conclusion, the incorporation of 3% SiO2 NPs significantly enhanced the mechanical properties of A-2000 MFSE both before and after two years of natural tropical weathering, whereas higher loading (10%) offered no additional benefit. These findings support the use of low-content SiO2 NPs to improve the long-term durability of maxillofacial prostheses.by Yaniga Swaengdee, Sararas Khongwirotphan, Jaravee Lasode, Phakakarn Kuecharoen, Phathayphout Phetvilay, Thitithep Limvorapitak, Anapat Sanpavat, Sira Sriswasdi, Piyaporn Boonsirikamchai, Yothin Rakvongthai
ObjectiveAccurately assessing residual disease after neoadjuvant chemoradiotherapy (nCRT) in locally advanced rectal cancer (LARC) remains challenging. Residual extramural venous invasion (EMVI) and perirectal lymph node (PLN) metastasis indicate adverse outcomes, but treatment-related changes obscure their detection on post-treatment MRI. This study developed MRI-based radiomics models to predict residual EMVI and PLN metastasis using post-nCRT restaging MRI.
Materials and methodsIn this retrospective study, 219 patients with LARC who completed nCRT and underwent post-treatment MRI for restaging prior to surgery were included. Radiomic features were extracted from manually segmented regions of interest encompassing the primary tumor and mesorectal fat on high-resolution T2-weighted images using PyRadiomics. Logistic regression (LR), support vector machine (SVM), and random forest (RF) models were developed to predict pathological EMVI and PLN status. Model performance was assessed using repeated 5-fold cross-validation, with the area under the receiver operating characteristic curve (AUC) as the primary evaluation metric. Differences in model performance were compared using DeLong test.
ResultsFor EMVI prediction, the combined tumor and mesorectal fat radiomics model achieved the highest AUC of 0.797 ± 0.073 using the LR model. For PLN prediction, the combined model also demonstrated superior performance, achieving an AUC of 0.824 ± 0.073. Models incorporating both tumor and mesorectal fat features consistently outperformed single-region models.
ConclusionMRI-based radiomics models using post-nCRT restaging images could predict residual EMVI and PLN metastasis in LARC. Incorporating mesorectal fat features improved model performance, suggesting that information from the surrounding mesorectal compartment may be useful for post-treatment risk assessment.
Children discharged after in-hospital treatment for severe anaemia or severe malaria in sub-Saharan Africa remain at high risk of readmission and death, particularly in malaria-endemic settings where recurrent infections are common. Post-discharge malaria chemoprevention (PDMC) has demonstrated substantial reductions in mortality and hospital readmissions and is now recommended by the WHO. However, optimal PDMC delivery strategies, via existing health systems, that optimise adherence remain unclear, particularly in West Africa where implementation and evidence of impact on clinical outcomes are limited. This trial aims to determine the effectiveness of different PDMC delivery strategies and adherence support mechanisms in optimising completion of PDMC courses. Secondary objectives include assessing clinical outcomes (readmissions, outpatient visits, mortality), evaluating health system linkage mechanisms and examining the acceptability and feasibility of the different delivery approaches.
A cluster-randomised implementation trial will be conducted in central and southern Benin across urban and rural settings. Clusters, defined as villages within the catchment areas of two referral hospitals, will be randomly allocated (1:1:1) to one of three arms: (A) facility-based drug distribution (all courses) at discharge with community health worker (CHW) home visit reminders; (B) monthly community-based drug delivery by CHWs combined with phone reminders; and (C) dispensing all courses to caregivers at discharge without adherence support (control). Eligible participants are children under 10 years hospitalised with severe anaemia or severe malaria and clinically stable at discharge. All participants should receive three courses of dihydroartemisinin–piperaquine at weeks 2, 6 and 10 post-discharge and will be followed for 14 weeks. The primary endpoint is incomplete adherence to the full PDMC regimen (3 courses/9 doses). Secondary endpoints include all-cause and malaria-specific readmissions, outpatient visits and mortality. Quantitative outcomes will be analysed using mixed-effects regression models under an intention-to-treat approach. Qualitative methods will assess acceptability and feasibility among caregivers, providers and policymakers.
Ethical approval was received from the institutional review boards of the Benin Institute of Applied Biomedical Sciences and Liverpool School of Tropical Medicine. Trial findings will be disseminated to national and international stakeholders through meetings, peer-reviewed publications and major conferences to inform PDMC policy, implementation guidelines and global malaria scale-up efforts, particularly through engagement with the World Health Organization and major malaria funding partners
Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, characterised by persistent pain after the rash subsides with a particularly high incidence among the elderly population. Its pathological mechanism involves peripheral and central sensitisation, often leading to severe pain, sleep disturbances, emotional issues and a decline in quality of life, posing a significant burden on healthcare and society. Current clinical treatments primarily rely on pharmacological and interventional therapies yet their efficacy remains suboptimal. Stellate ganglion block (SGB), as an interventional technique targeting the sympathetic nervous system, is believed to alleviate PHN by modulating neurovascular function, inhibiting inflammatory responses and blocking pain transmission pathways. However, evidence-based data on its efficacy and safety remain insufficient and existing study results are inconsistent. Therefore, this study aims to comprehensively evaluate the effectiveness and safety of SGB in treating PHN through a systematic review and meta-analysis.
This systematic review and meta-analysis will be conducted in strict accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search will be performed for relevant randomised controlled trials published from the inception of each database until 31 December 2025, in PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Database and VIP Database. Two researchers will independently complete the literature screening, data extraction and cross-verification. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias tool. Statistical analysis will be performed using RevMan V.5.4 software: continuous variables will be analysed by calculating the mean difference and 95% CI, and dichotomous variables will be analysed by calculating the OR and 95% CI. Based on the results of heterogeneity testing (I² statistic), either a fixed-effects model or a random-effects model will be employed for data synthesis. Subgroup analyses and sensitivity analyses will be conducted to explore sources of heterogeneity, and a grading system will be used to assess the quality of the evidence.
Ethical approval is not required for this study, as it does not involve the collection of primary data from individual patients. Findings will be disseminated through peer-reviewed publication and conference presentations.
CRD420251128909.
To systematically synthesise qualitative evidence on the experiences of chronic heart failure (CHF) patients using mobile health (mHealth) tools for self-management and to identify factors influencing their acceptance and adherence, thereby informing the development of more patient-centred solutions.
Qualitative meta-synthesis.
A comprehensive search was conducted using terms related to mHealth, heart failure, self-management and qualitative research. Study quality was appraised using the Joanna Briggs Institute criteria for qualitative studies, and data were synthesised using thematic synthesis. The search covered the period from database inception to July 2025.
The following eight electronic databases were searched: PubMed, Ovid, CINAHL, Web of Science, PsycINFO, China National Knowledge Infrastructure, Wangfang and VIP
A total of 18 studies were included, yielding two integrated themes: factors influencing the use of mHealth tools and recommendations for their development.
Experiences of patients with CHF using mHealth underscore the need for a patient-centred paradigm in mHealth design. Codesigning tools based on patients’ real-world needs and preferences is crucial to promote sustained engagement and effective self-management. Healthcare professionals and developers should prioritise usability, personalisation and continuous support to enhance acceptance.
CRD420-25638367.
Tea-tribe communities in Assam face a substantial and under-recognised burden of stroke, shaped by socioeconomic marginalisation, limited access to formal healthcare and distinct cultural practices.
We estimated the prevalence of physician-diagnosed stroke, described associated functional and psychological disabilities, characterised gaps in diagnosis and care, and developed a logistic regression-based classification score for prevalent stroke among tea-tribe adults in Cachar district, Assam, Northeast India.
We conducted a community-based cross-sectional door-to-door survey (July 2024–August 2025) across five tea estates among permanent tea-tribe residents aged ≥18 years. Trained community health workers collected data on sociodemographics, vascular risk factors, healthcare utilisation and poststroke functional and psychological outcomes using a structured questionnaire, the Modified Rankin Scale and a symptom inventory. Stroke was identified through community symptom screening and confirmed by teleconsultation with a senior neurologist, supported by neuroimaging where available. A multivariable logistic regression model with stepwise selection identified factors associated with prevalent stroke and regression coefficients were converted into an additive point-based classification score. Internal validation used 1000 bootstrap samples and a 70:30 train–test split. The model performance was assessed using the area under the receiver operating characteristic curve and Brier score.
Among 3818 participants, 164 had a history of stroke (prevalence 4.3%), with a higher prevalence in older adults, men, unemployed or semiskilled or skilled workers and households below the poverty line. Hypertension was the strongest risk factor and its combination with daily tea containing added salt was associated with markedly higher odds of stroke. Alcohol consumption, smoking and previous heart disease were also associated with stroke. Stroke survivors had high functional and psychological burdens and fewer than half reached a health facility within 4.5 hours or underwent CT/MRI. The final model showed good discrimination (area under the curve 0.84) and calibration (Brier score 0.037). The derived classification score (0–19 points) identified a highly associated group (scores >13) with a stroke prevalence of 14.5%.
The tea-tribe community in Assam faces a high stroke burden, substantial disability and major gaps in timely diagnosis and care. A simple, internally validated classification score based on demographic, socioeconomic and vascular factors may help target community screening and prevention but requires external validation and cautious interpretation given the cross-sectional design and self-reported exposures.
Recanalisation rates following standard intravenous thrombolysis (IVT) for acute ischaemic stroke due to medium or large vessel occlusion (MeVO/LVO) remain unsatisfactory, leading to poor clinical outcomes. Tenecteplase (TNK), a fibrin-specific thrombolytic agent, demonstrates potential advantages over alteplase, including higher recanalisation rates in LVO. Preliminary evidence suggests that a second dose of thrombolytic in patients with persistent vessel occlusion after initial IVT may be feasible and beneficial. This study aims to evaluate the efficacy and safety of a second intravenous dose of TNK administered to patients with acute anterior and posterior circulation MeVO/LVO who have not recanalised 1 hour after standard IVT.
RITIS-TNK2 is a prospective, randomised, open-label, blinded endpoint, multicentre, superiority trial. Eligible patients will be randomly assigned (1:1) to receive a second dose of TNK (0.25 mg/kg intravenously, capped at a maximum total dose of 16 mg) plus standard medical care or standard medical care alone. The primary efficacy outcome is the recanalisation rate of the occluded artery at 24 hours after randomisation. The primary safety outcome is symptomatic intracranial haemorrhage within 24 hours. Secondary outcomes include functional status at 90 days (modified Rankin Scale score). The expected recanalisation rate at 24 hours in the control group is estimated at 45%. We hypothesise rescue TNK will raise 24-hour recanalisation rate from 45% to 65%, representing an absolute 20 percentage-point improvement and a relative 44.4% increase. A maximum of 198 patients are required to test the superiority hypothesis with 80% power according to a two-sided 0.05 level of significance.
This study has been approved by the central Institutional Review Board (General Hospital of Northern Theater Command; IRB: Y (2025) 502). The study results will be disseminated through peer-reviewed journals and presentation at relevant national and international scientific conferences, regardless of the direction of the findings.
Fibrosing interstitial lung diseases (F-ILD) affect substantial patient populations with significant mortality and socioeconomic burden. Approximately one-third of patients with F-ILD develop a progressive fibrosing phenotype with poor outcomes. Current monitoring methods, including pulmonary function testing and high-resolution CT (HRCT), often lag behind increases in fibrotic activity, limiting early risk identification and optimal treatment timing. Fibroblast activation protein (FAP) imaging can capture fibrotic activity at the pathological level. This study aims to evaluate the incremental value of ⁹⁹Tc-FAPI single-photon emission CT (SPECT)/CT for early warning of disease progression in F-ILD and develop a predictive model integrating fibroblast activation protein inhibitor (FAPI) quantitative parameters with clinical variables.
This prospective, single-centre, observational cohort study will recruit 380 adult patients with confirmed F-ILD diagnoses from December 2024 to June 2027, with 12-month follow-up. Comprehensive baseline evaluation includes pulmonary function testing, 6-min walk test, laboratory investigations and ⁹⁹Tc-FAPI SPECT/CT imaging. Follow-up visits at 3, 6 and 12 months will assess clinical outcomes. The primary outcome is disease progression within 12 months, defined as ≥5% forced vital capacity decline, ≥10% diffusing capacity of the lungs for carbon monoxide decline, increased fibrosis on HRCT, acute exacerbation or death. Cox proportional hazards regression models will be used for predictive model construction, with internal validation using bootstrap resampling and temporal split methods.
The study protocol has been approved by the Ethics Committee of Fujian Provincial Hospital (K2024-11-010) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publications and academic conference presentations. De-identified individual participant data will be available upon reasonable request after primary publication.
Chinese Clinical Trial Registry ChiCTR2400093808.
Malignant biliary obstruction (MBO) is a common complication of pancreaticobiliary and periampullary malignancies and is associated with substantial morbidity and reduced survival. Multiple biliary drainage strategies are available, including endoscopic, percutaneous and surgical approaches, as well as adjunctive therapies. However, direct head-to-head comparisons remain limited, and the relative effectiveness and safety of these interventions are not well established. This study aims to compare the effectiveness and safety of different biliary drainage strategies for MBO using a network meta-analysis, allowing both direct and indirect comparisons and enabling ranking of treatment strategies.
This protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. We will systematically search MEDLINE via PubMed, Embase via Elsevier, Web of Science Core Collection via Clarivate, and the Cochrane Central Register of Controlled Trials via the Cochrane Library from inception to 30 June 2026. Randomised controlled trials (RCTs) and non-randomised comparative studies will be included. Interventions of interest include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound-guided biliary drainage (EUS-BD), percutaneous transhepatic biliary drainage (PTBD), surgical bypass and adjunctive therapies combined with drainage (eg, photodynamic therapy or radiofrequency ablation). Primary outcomes will include technical success, clinical success and quality of life. Secondary outcomes will include adverse events, reintervention rates, overall survival, 30-day all-cause mortality, stent patency duration and length of hospital stay. Risk of bias will be assessed using the Cochrane Risk of Bias two tool for RCTs and the ROBINS-I tool for non-randomised studies. A random-effects network meta-analysis will be conducted within a frequentist framework. Consistency and transitivity assumptions will be assessed, and treatment ranking will be estimated using the surface under the cumulative ranking curve. Subgroup analyses will be performed according to clinically relevant factors, including obstruction site, stent type, tumour type and treatment setting. The certainty of evidence will be evaluated using the GRADE approach adapted for network meta-analysis.
Ethical approval is not required, as this study is based on published data. Findings will be disseminated through peer-reviewed publication.
CRD420261373097
Inappropriate and broad-spectrum antibiotic use contributes to antimicrobial resistance (AMR) and higher healthcare costs. In Saudi Arabia, despite ongoing antimicrobial stewardship efforts, comprehensive real-world evidence on antibiotic prescribing patterns remains limited. This study aimed to evaluate antibiotic prescribing among insured (Daman) beneficiaries in Saudi Arabia and benchmark against international standards.
Retrospective analysis of deidentified health insurance claims from the National Platform for Health and Insurance Exchange Services (NPHIES), covering 1 November 2023–31 October 2024.
Antibiotic prescriptions were identified within claims and linked to diagnostic codes using the International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) to determine clinical indications for use.
Among 4.02 million claimants, 8.3 million antibiotic prescriptions were identified.
Antibiotic claims were mapped to the Saudi Food and Drug Authority (SFDA) drug list. Hospital antibiotic consumption was expressed as defined daily doses (DDD) per 100 patient-days for five selected inpatient antibiotics, whereas overall antibiotic consumption (in both community and hospital settings) was expressed as DDD per 1000 insured persons per day. Treatment duration, prescriber specialty and patient demographics were measured. Appropriateness of antimicrobial prescribing for respiratory tract infections was assessed using Healthcare Effectiveness Data and Information Set (HEDIS) metrics.
Age-stratified and sex-stratified antibiotic prescription rates showed disproportionately high use in male infants (509.6 prescriptions per 1000) and older males (641.9 prescriptions per 1000). General practitioners accounted for 80% of prescriptions. Broad-spectrum beta-lactams, particularly amoxicillin–clavulanate, predominated. Overall antibiotic consumption was 11.63 DDD per 1000 insured persons per day, comparable to European Surveillance of Antimicrobial Consumption Network (ESAC-Net) outpatient benchmarks. Mean treatment durations ranged 8–14 days, exceeding global stewardship recommendations. HEDIS indicators revealed overprescribing, particularly for upper respiratory tract infections.
This is the first claim-based analysis of antibiotic prescribing patterns among Daman beneficiaries in Saudi Arabia. Decision support systems, artificial intelligence-driven audits and targeted education could optimise prescribing, reduce AMR and inform policy.
Type 2 diabetes mellitus (T2DM) imposes clinical and economic burdens worldwide, with the Kingdom of Saudi Arabia (KSA) reporting among the highest prevalence rates in the Middle East and North Africa (MENA) region. Despite national diabetes initiatives under Vision 2030 and recent guideline implementation, evidence on T2DM management among privately insured beneficiaries remains limited. This study aimed to provide one of the first real-world assessments of antidiabetic treatment patterns, therapy modifications, medication adherence and guideline-recommended glycaemic monitoring among privately insured patients with T2DM in KSA.
Longitudinal retrospective cohort study.
A national claims-based analysis was conducted using the National Platform for Health Information Exchange Services (NPHIES), covering privately insured beneficiaries across KSA. The study period spanned from 1 September 2022 to 31 December 2024.
Eligible participants were privately insured individuals aged ≥15 years with a diagnosis of T2DM, defined as having at least one medical claim of T2DM (International Classification of Diseases, 10th Revision, Australian Modification code E11) and continuous insurance enrolment for a minimum of 12 months (including ≥180 days pre-index and ≥180 days post-index). The index date was defined as the earliest observed antidiabetic prescription within the study window. A total of 187 797 patients met the inclusion criteria and were included in the final analysis.
The primary outcomes were antidiabetic real-world treatment patterns and therapy modifications, including treatment escalation, switching, early discontinuation and medication adherence. Secondary outcomes included guideline-recommended laboratory testing of glycaemic control for haemoglobin A1c (HbA1c), plasma glucose tests and oral glucose tolerance test. Claims were linked to the Council of Health Insurance’s internal product dictionary using the NPHIES product/service code to retrieve the standardised product name and activity type. Data extraction used Structured Query Language-based queries and Python transformation.
Patients had a mean age of 53.7 years, while T2DM rates reached 47.4 per 1000 insured men and 43.8 per 1000 insured women. Combination therapy accounted for 29.4% of initial treatment regimens among eligible patients with T2DM. Biguanide monotherapy users exhibited switching and escalation rates of 9% and 7%, respectively, while 35% of sulfonylurea users exhibited escalation. Treatment discontinuation was observed in 22% of users of combination therapies, 22% of SGLT2 inhibitor users and 19% of sulfonylurea users. The medication possession ratio was 0.87 for insulin users. Regarding laboratory monitoring, 61% of patients had at least one glycaemic test 6 months prior to therapy initiation. Laboratory testing reached 73% following therapy initiation.
The Saudi experience suggests that integrated national claims platforms, supported by standardised coding and e-prescribing, can play a critical role in advancing real-world evidence generation and informing diabetes management strategies in KSA and across MENA health systems.
Hand expression is a manual method of milk expression that requires no equipment and is commonly used in the early postpartum period, particularly when direct breastfeeding is not possible or not effective. Randomised trials have reported mixed findings across different maternal–infant contexts. This review aims to synthesise randomised evidence on the effects of postpartum hand expression on expressed milk volume and breastfeeding outcomes.
We will include individually randomised parallel-group controlled trials involving human postpartum women expressing breast milk in the early postpartum period. The intervention is postpartum hand expression; comparators will include electric or manual pump expression and usual care without structured hand-expression training. We will search PubMed, Embase, CINAHL, PsycINFO, Web of Science and CENTRAL from inception, without language or date restrictions and also search OpenGrey, ClinicalTrials.gov and WHO ICTRP, plus reference lists. Two reviewers will independently screen studies, extract data and assess risk of bias using the Risk of Bias tool for randomised trials, version 2. Eligible outcomes include expressed milk volume, breastfeeding outcomes, supplementation, time to onset of copious milk secretion and maternal outcomes. Where appropriate, we will conduct pairwise meta-analyses, calculating risk ratios for dichotomous outcomes and mean differences or standardised mean differences for continuous outcomes with 95% CIs. Heterogeneity will be assessed using ² and I², with prespecified subgroup and sensitivity analyses. Certainty of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).
This study will be based on previous research findings, so that ethics approval is not required. Data searching commences in June 2026 and expects to complete in January, 2027. The findings will be disseminated through peer-reviewed journals and academic conferences.
CRD420261327070.
FreshRSS 