Protocol of the Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS): a Multiphase Optimization Strategy (MOST) study implementing a gamified mHealth intervention to reduce postdischarge suicide risk in patients with mental disorders in Shenzhen

Introduction
Postdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science.

Methods and analysis
This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes.

Ethics/dissemination
The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission.

Trial registration number
ClinicalTrials.gov, ID: NCT06358339

Leggi
Aprile 2025

Predictive value of burnout complaints and depressive symptoms for medically certified sickness absence among physicians in Sweden: a 1 year follow-up observational study

Objective
This study aimed to explore the predictive value of severe burnout complaints, symptom dimension of burnout and depressive symptoms for subsequent all-cause medically certified sickness absence (ACMCSA) during the pandemic among physicians in Sweden.

Design
A 1 year follow-up panel cohort observational study—the Longitudinal Occupational Health Survey for HealthCare in Sweden. At baseline (February–May 2021), a representative sample of 6699 physicians was drawn from the Swedish occupational register and invited to participate in the study. At follow-up (March–May 2022), the full sample (excluding those who died, retired, stopped working as a physician or migrated, n=94) was invited to answer the survey.

Setting
Swedish primary and specialist healthcare.

Participants
At baseline, the response rate was 41.3% (n=2761) of which 1575 also answered at follow-up.

Primary and secondary outcome measures
ACMCSA data came from the Swedish Social Insurance Agency. The Burnout Assessment Tool (BAT-23) was used to measure burnout, including a burnout total score and scores for the four symptom dimensions of exhaustion, mental distance, emotional impairment and cognitive impairment. Depressive symptoms were assessed using the Symptom Checklist-core depression (SCL-CD6). Associations between baseline burnout and depressive symptoms and subsequent ACMCSA were estimated with logistic regression analyses.

Results
ACMCSA was found in 9% of the participating physicians. In the sample, 4.7% had severe burnout complaints, and 3.7% had depressive symptoms. Burnout (OR=2.57; 95% CI=1.27 to 5.23) and the burnout symptom dimensions emotional impairment (OR=1.80; 95% CI=1.03 to 3.15) and cognitive impairment (OR=2.52; 95% CI=1.12 to 5.50) were associated with a higher likelihood of subsequent ACMCSA. Depressive symptoms were not associated with ACMCSA when adjusted for severe burnout complaints and other covariates.

Conclusion
This study demonstrates the distinction between burnout and depressive symptoms, particularly in predicting future ACMCSA. Early intervention targeting exhaustion and burnout may mitigate symptom development and reduce the risk of ACMCSA.

Leggi
Aprile 2025

Comparison of non-invasive and fluorescein tear film break-up time in a 65-year-old Norwegian population: a cross-sectional study

Objectives
Measurement of tear film stability is central in dry eye disease (DED) diagnosis. In this study, we aimed to compare the performance of two methods of tear film stability measurement: non-invasive tear break-up time (NIBUT) and fluorescein tear film break-up time (FTBUT).

Design
Cross-sectional study.

Setting and participants
The study involved 132 subjects of 65-year-old inhabitants of the Oslo region who were not seeking ophthalmic care.

Interventions
The participants underwent a battery of DED tests, including NIBUT measured on Oculus Keratograph 5M and a traditional method using fluorescein drops (FTBUT). Oculus Keratograph 5M measures two types of NIBUT:; appearance time of the first dry spot (NIBUTFirst) and average NIBUTAvg.

Results
74 participants (56%) were female and 58 were male (44%). Subjects presented with varying degrees of DED signs and symptoms. Mean values of NIBUTFirst and FTBUT from all the participants were significantly different (6.2±4.9 s vs 8.6±6.2 s, p

Leggi
Aprile 2025

Recurrence of hypoglycaemia and associated factors among neonates admitted with perinatal asphyxia in Northwest Ethiopia: multicentre, retrospective follow-up study with negative binomial regression

Objective
To estimate the recurrence of hypoglycaemia and the associated factors in neonates with birth asphyxia admitted to the neonatal intensive care unit in Northwest Amhara region’s comprehensive specialised hospitals, Northwest Ethiopia, in 2024.

Design
A multicentre, institution-based, retrospective follow-up study.

Setting
Tertiary hospitals in Northwest Amhara Regional State, Northwest Ethiopia, from 1 July 2020 to 30 July 2024.

Participants
A total of 761 neonates with perinatal asphyxia were admitted to the neonatal intensive care unit of selected public hospitals in Northwest Amhara from July 2020 to July 2024.

Outcome measure
The primary outcome measure of this study was recurrence of hypoglycaemia. Furthermore, the factors associated with recurrence of hypoglycaemia in newborns with perinatal asphyxia were noted.

Results
The average number of hypoglycaemia cases among neonates with birth asphyxia was 2.05 (95% CI 1.939, 2.163) over the 28-day follow-up period. Meningitis (adjusted incidence rate ratio (AIRR)=1.16; 95% CI 1.04, 1.30), feeding in less than 72 hours (AIRR=1.17; 95% CI 1.05, 1.31), stage 3 hypoxic-ischaemic injury (AIRR=1.20; 95% CI 1.04, 1.39), length of hospital stay (AIRR=1.01; 95% CI 1.01, 1.03) and macrosomia (AIRR=1.39; 95% CI 1.19, 1.63) were significant factors associated with recurrence of hypoglycaemia.

Conclusions and recommendations
The current study indicated that the mean recurrence of hypoglycaemia in newborns experiencing perinatal asphyxia was considerably higher. Presence of neonatal meningitis, delayed initiation of feeding 72 hours after birth, stage 3 hypoxic-ischaemic injury, length of hospital stay and macrosomia were the key factors associated with recurrence of hypoglycaemia.

Leggi
Aprile 2025

Protocol of the follow-up of patients with transthyretin amyloid cardiomyopathy by multimodality imaging (FAITH) study: a prospective observational study in patients with ATTR-CM undergoing treatment with tafamidis

Introduction
This prospective observational study of patients with transthyretin amyloid cardiomyopathy (ATTR-CM) undergoing treatment with tafamidis aims at identifying quantitative image markers and comparing imaging modalities regarding the follow-up and prognostication of these patients, with the goal of providing a multiparametric score to predict treatment response.

Methods and analysis
Patients with a board-approved decision to receive tafamidis will undergo, in addition to standard of care, baseline and follow-up cardiovascular magnetic resonance (CMR) scans at 9 and 18 months. In total, the study plans to recruit and scan 60 patients. A blinded read will take place in a CMR research core laboratory. The final statistical analysis will be based on developing a multiparametric score for the prediction of treatment response. The study will be managed through the Amyloidosis Center Charité Berlin, a clinical unit formed from the three clinical campus sites of the Charité in Berlin, using the Berlin Research Network for CMR.

Ethics and dissemination
The study was approved by the Charité—Universitätsmedizin Berlin ethics committee EA1/262/23. The results of the study will be disseminated through international peer-reviewed publications and congress presentations.

Trial registration number
Approved WHO primary register: German Clinical Trials Register: https://www.drks.de/DRKS00033884. WHO International Clinical Registry Platform: https://trialsearch.who.int/?TrialID=DRKS00033884. Recruitment started on 1 July 2024.

Leggi
Marzo 2025

Cohort profile: the Genetics of Glucose regulation in Gestation and Growth (Gen3G) – a prospective prebirth cohort of mother-child pairs in Sherbrooke, Canada, 3-year and 5-year follow-up visits

Purpose
Initiated in 2010, the Genetics of Glucose regulation in Gestation and Growth (Gen3G) prospective cohort investigates the pathophysiology of impaired glycaemic regulation in pregnancy and evaluates its impact on both the mothers and her offspring health trajectory. Follow-up visits 3 and 5 years after delivery aimed to investigate pregnancy-related risk factors such as maternal obesity and gestational hyperglycaemia in relation to the mother’s metabolic health after pregnancy, and with offspring health outcomes such as risk of obesity and neurodevelopmental problems in early childhood. We also investigated molecular mechanisms involved in the fetal programming of these later health outcomes.

Participants
Of the 1024 women originally recruited in the first trimester of pregnancy, we have targeted the 854 who had complete glucose tolerance test data and the 724 newborns who provided placenta and/or cord blood samples for follow-up recruitment. Of these, 695 mother–child dyads agreed to be contacted for the prospective follow-up visits. 448 and 521 mother–child dyads completed the research visits at 3 and 5 years after delivery respectively.

Findings to date
At both visits, we collected the mother’s and child’s medical history, lifestyle (using validated questionnaires), sociodemographic status, anthropometric measurements, mother’s blood samples, child’s saliva samples and growth charts. At the 5-year-old visit, we additionally collected the mother’s and child’s urine and stool samples and the child’s blood samples; we performed a 75 g oral glucose tolerance test in the mothers and assessed the body composition in children using dual-energy X-ray absorptiometry. Using the Gen3G rich longitudinal data set, we have enhanced the understanding of the pathophysiology and characterisation of the heterogeneity of gestational diabetes mellitus, and we have shown that gestational hyperglycaemia and insulin resistance are associated with offspring epigenetics (DNA methylation) variations in the placenta, cord blood and blood at 5 years of age, as well as with offspring anthropometric, metabolic and neurodevelopmental outcomes in early childhood.

Future plans
We are currently conducting a prospective follow-up of mothers and their children 12 years after delivery to study how prenatal and early-life metabolic factors may programme childhood adiposity and obesogenic dietary behaviours. This follow-up should be completed by the end of 2026.

Leggi
Marzo 2025

Stenting Versus Medical Therapy for Symptomatic Intracranial Artery Stenosis: Long-Term Follow-Up of a Randomized Trial

Stroke, Ahead of Print. BACKGROUND:Whether the long-term benefit of stroke prevention when stenting is added to medical therapy (MT) over MT alone for symptomatic severe intracranial artery stenosis offsets the perioperative risks of the stenting has not been directly evaluated in a randomized trial. We aimed to compare the long-term ( >3 years) effect of stenting versus MT alone in patients with symptomatic severe intracranial artery stenosis in a randomized trial.METHODS:We extended the follow-up of 358 subjects enrolled in a multicenter, open-label, randomized trial conducted at 8 centers in China. Patients with transient ischemic attack or stroke attributed to severe intracranial stenosis (70% to 99%) were recruited between March 5, 2014, and November 10, 2016. The primary outcome was a composite of stroke or death within 30 days or stroke in the territory of the qualifying artery beyond 30 days. Other secondary outcomes included stroke in the territory of the qualifying artery, as well as disabling stroke or death after enrollment.RESULTS:A total of 358 patients (stenting 176 versus MT 182) were recruited from March 5, 2014, and followed up till January 22, 2024. The median duration of follow-up was 7.4 years (interquartile range, 6.0–8.0). The primary outcome was not significantly different (stenting 14.8% versus MT 14.3%; hazard ratio, 1.02 [95% CI, 0.58–1.77];P=0.97). No significant difference was found between groups for the secondary outcomes: stroke in the territory of qualifying artery (14.8% versus 14.3%; hazard ratio, 1.02 [95% CI, 0.58–1.77];P=0.97), disabling stroke or death (16.5% versus 14.3%; hazard ratio, 1.12 [95% CI, 0.66–1.91];P=0.70), and death (9.1% versus 7.1%; hazard ratio, 1.22 [95% CI, 0.58–2.58];P=0.60).CONCLUSIONS:This study provides compelling evidence that, even over prolonged observed periods, the addition of stenting to MT does not confer additional benefits to MT alone in patients with symptomatic severe intracranial artery stenosis. These results underscore the importance of MT as the cornerstone of long-term stroke prevention in this patient population.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01763320.

Leggi
Marzo 2025

Barriers to annual diabetic retinopathy screening and subsequent recommended follow-up adherence among Chinese diabetics: a cross-sectional and longitudinal study

Objectives
Adherence to routine annual eye evaluations for diabetes is frequently insufficient on a global scale. We evaluated the adherence to annual diabetic retinopathy screening (DRS) and recommended follow-up among Chinese patients with diabetes, and we also identified the associated risk variables.

Design
This was a cross-sectional and longitudinal study.

Setting
Patients with diabetes were inquired about their completion of DRS within the preceding year. All participants were required to complete the Compliance with Annual Diabetic Eye Exams Survey.

Participants
Participants with diabetes who initially sought eye examination from November 2021 to October 2023 at He Eye Specialist Hospital, Shenyang, China.

Outcome measures
Logistic regression analyses defined the risk factors associated with poor compliance with the annual DRS and recommended follow-up.

Results
There were 468 patients registered, with a mean age of 67.42±10.66 years. A total of 308 (65.8%) participants had DRS in the previous year. Rural residents (OR 1.704, 95% CI 1.019 to 2.850, p=0.042), vision-threatening diabetic retinopathy (VTDR) (OR 1.948, 95% CI 1.145 to 3.313, p=0.014), item 7 (over the past 4 weeks, I have felt blue, downhearted or depressed) (OR 0.624, 95% CI 0.401 to 0.971, p=0.037) and item 42 (I receive a reminder from my eye doctor’s office when it is time to schedule an exam) (OR 0.618, 95% CI 0.387 to 0.989, p=0.045) were associated with non-adherence to annual DRS. The compliance with DRS improved to 80.9% in the second year after health education and reminders of follow-up. VTDR (OR 3.063, 95% CI 1.852 to 5.066, p

Leggi
Marzo 2025

Incidence of tuberculosis and its predictors among children on antiretroviral therapy in Amhara Region, Ethiopia: a multicentre institution-based retrospective follow-up study

Introduction
Tuberculosis (TB) continues to be a significant public health issue, particularly in low-income and middle-income countries. Globally, the End TB Strategy targets an 80% reduction in TB incidence by 2030. Despite this strategy, there remains limited evidence on the incidence of TB among HIV-infected children after the test-and-treat strategies in Amhara Region. Hence, this study aimed to assess the incidence of TB and its predictors among children on antiretroviral therapy (ART) in Amhara Region, which is the second largest region in Ethiopia and located in the northwestern, northeastern and north-central parts of Ethiopia.

Methods
A multicentre institution-based retrospective follow-up study was conducted on 421 HIV-infected children receiving ART from July 2014 to March 2022. The study participants were selected using simple random technique. National antiretroviral intake and follow-up forms were used to gather data through the KoBo Toolbox. Stata V.17 was used for data analysis. The Kaplan-Meier curve was applied to estimate failure time, and the log-rank test was employed to compare groups of predictors. To identify TB predictors, Gompertz regression models, both bivariable and multivariable, were constructed. Ultimately, a 95% CI adjusted HR (AHR) was calculated, and variables with a p value less than 0.05 were considered statistically significant.

Results
A total of 421 children with a record completeness rate of 97.9% were analysed in the study. The TB incidence rate in children on ART was 2.16 (95% CI 1.52, 3.05) per 100 child-year observations. Anaemia at baseline (AHR: 3.83; 95% CI 1.46, 10.04), never taking TB preventive treatment (TPT) (AHR: 3.78; 95% CI 1.44, 9.94), wasting (AHR: 2.53; 95% CI 1.19, 5.38) and not initiating ART within 7 days (AHR: 2.35; 95% CI 1.15, 4.78) were significant predictors of TB in children.

Conclusion
The incidence of TB in children on ART was relatively high. HIV-positive children presenting with anaemia, those who never took TPT, wasted children and those with late initiation of ART were prone to the occurrence of TB. Therefore, prioritising anaemia treatment, TB preventive therapy, nutritional counselling and timely initiation of ART are essential to curb the TB burden.

Leggi
Febbraio 2025

Efficacy of unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A) in China: protocol for a randomised controlled trial

Introduction
Emotional disorders are highly prevalent among adolescents, with a high rate of comorbidity. Convenient and effective treatment options are needed to reduce costs and improve effectiveness. The unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A) is an evidence-based transdiagnostic approach aimed at ameliorate emotional symptoms. The objective of this study is to assess the efficacy of the UP-A in Chinese adolescents with emotional disorders using multidimensional evaluations.

Methods and analysis
This study is a two-armed, randomised controlled trial on the efficacy of 12 week UP-A on adolescents with emotional disorders along with their parents. Forty-eight participants will be randomly assigned to either the treatment as usual (TAU) group or the TAU combined with UP-A (UP-A+TAU) group. We will evaluate the efficacy of the UP-A, through the following primary and secondary outcomes: emotional disorder severity, emotional symptoms, emotion regulation, cognitive patterns, executive function, resilience, quality of life, social and family functioning. Participants will be assessed at baseline (T1), week 4 (T2), week 8 (T3), post-treatment (T4) and 3 month follow-up (T5).

Discussion
This protocol outlines the first randomised controlled trial investigating the efficacy of the UP-A among Chinese adolescents with emotional disorders. The findings may contribute to providing an effective and feasible transdiagnostic intervention in Chinese clinical settings.

Ethics and dissemination
This trial has been approved by the Ethics and Clinical Research Committees of Peking University Sixth Hospital and will be performed under the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results will be disseminated in a peer-reviewed journal and a conference presentation.

Trial registration number
ChiCTR2300069354.

Leggi
Febbraio 2025

YEARS clinical decision rule for diagnosing pulmonary embolism: a prospective diagnostic cohort follow-up study in primary care

Objectives
The Wells rule is often used in primary care to rule out pulmonary embolism (PE), but its efficiency is low as many referred patients do not have PE. In this study, we evaluated in primary care an alternative and potentially more efficient diagnostic strategy—the YEARS algorithm; a simplified three-item version of the Wells rule combined with a pretest probability adjusted D-dimer interpretation.

Design
In this comprehensive prospective diagnostic validation study, primary care patients suspected of PE were enrolled by their general practitioner. All three YEARS items were collected in addition to D-dimer results, and patients were followed for 3 months to establish the final diagnosis.

Setting
Primary care in the Netherlands.

Participants
753 patients with suspected acute PE were included. Five patients (0.7%) were lost to follow-up.

Main outcome measures
Failure rate (number of PE cases among patients classified by the algorithm as ‘PE ruled-out’) and efficiency (fraction of patients classified as ‘PE probable/further imaging needed’).

Results
Prevalence of PE was 5.5% (41/748 patients). In total, 603 patients were classified as ‘PE ruled-out’ by the YEARS algorithm (532 with zero YEARS items and a D-dimer

Leggi
Febbraio 2025