Atosiban versus placebo in the treatment of threatened preterm birth between 30 and 34 weeks gestation: study protocol of the 4-year APOSTEL 8 follow-up

Introduction
Currently, the majority of women worldwide with threatened preterm birth are treated with tocolytics. Although tocolytics can effectively delay birth for 48 hours, no tocolytic drug has convincingly been shown to improve neonatal outcomes and effects on long-term child development are unknown. The aim of this follow-up study of a placebo controlled randomised trial is to investigate the long-term effects of atosiban administration in case of threatened preterm birth on child’s neurodevelopment and behaviour development, overall health and mortality.

Methods and analysis
This protocol concerns a follow-up study of the multicentre randomised double-blind placebo controlled APOSTEL 8 trial (NL61439.018.17, EudraCT-number 2017-001007-72). In this trial, women with threatened preterm birth (between 30 and 34 weeks of gestation) defined as uterine contractions with (1) a cervical length of

Leggi
Luglio 2024

Long-term follow-up in outpatients with mildly elevated pulmonary artery systolic pressure on echocardiography: a single-centre retrospective cohort study in Shanghai, China

Objective
To investigate the correlation between mildly elevated pulmonary artery systolic pressure (PASP) on echocardiography and mortality, as well as long-term changes in PASP.

Design
Retrospective cohort study.

Setting
Shanghai, China, a single centre.

Participants
A total of 910 patients were enrolled in this study. From January to June 2016, 1869 patients underwent echocardiography at the Zhongshan Hospital affiliated with Fudan University. Patients with malignant tumours, previous heart or other solid organ transplantation, previous or scheduled ventricular assist device implantation, severe kidney dysfunction (uraemia and patients on dialysis) and a life expectancy of less than 1 year for any medical condition were excluded.

Interventions
No interventions were done.

Primary and secondary outcome measures
The predictors of death in patients with mild echocardiographic pulmonary hypertension were analysed using univariate and multivariate Cox regression analyses. Paired t-tests were used to calculate changes in the PASP values at baseline and follow-up for different patient groups.

Results
The 5-year survival of patients was 93.2%. Patients were grouped according to whether they had combined organic heart disease (OHD). The PASP value was an independent predictor of all-cause mortality in patients with OHD, with each 1 mm Hg increase associated with an HR of 1.02 (95% CI: 1.01–1.03, p=0.038) but not in patients without OHD. Of the total, 46% (419/910) of the patients with 5–6 years of echocardiography were investigated for changes in the PASP value. We found significant PASP reduction in patients without OHD (42.8±2.4 mm Hg vs 39.3±8.2 mm Hg, p

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Luglio 2024

Characteristics and feedback of adult survivors of childhood cancer seen in Swiss comprehensive follow-up clinics led by general internists: a prospective cohort study

Objectives
In our study, we aimed to characterise adult childhood cancer survivors (ACCS), assess their health issues, gauge health-related quality of life (HRQOL) and evaluate visit satisfaction.

Design
Prospective cohort study using data from clinical visits and questionnaires.

Setting
Interdisciplinary follow-up programme for ACCS based on the long-term follow-up (LTFU) guidelines of the Children’s Oncology Group and overseen by internists in two Swiss hospitals.

Participants
ACCS attending our LTFU clinics between April 2017 and January 2022 were eligible.

Interventions
We documented medical history, current health status and assessed HRQOL using Short Form-36 V.2, comparing it with Swiss general population (SGP) norms (T mean=50, SD=10; age stratified). 3 months post visit, a feedback questionnaire was distributed.

Main results
Among 102 ACCS (mean age: 32 years (range: 18–62 years), 68% women), 43 had no prior follow-up (36 ACCS >28 years, 7 ACCS≤28 years). A notable 94% had health issues, affecting an average of 6.1 (SD=3.3) organ systems. HRQOL was lower in ACCS >28 years than the SGP >28 years (physical: 44.8 (SD=11.65) vs 49.3 (SD=10.29), p=0.016; mental: 44.4 (SD=13.78) vs 50.53 (SD=9.92), p=0.004). Older ACCS ( >28 years) reported inferior physical (44.8 vs 50.1 (SD=9.30), p=0.017) and mental HRQOL (44.4 vs 50.3 (SD=7.20), p=0.009) than younger ACCS. The majority of respondents reported high levels of satisfaction with the consultation, exceeding 90%.

Conclusion
ACCS attending LTFU clinics face diverse health issues impacting multiple organ systems and exhibit lower HRQOL compared with the SGP. Thus, internist-led LTFU clinics are crucial for optimising follow-up care.

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Luglio 2024

Heart rate vARiability and physical activity in inpatient treatMent of burnOut and DepressIon (HARMODI): protocol of a cross-sectional study with up to 8-week follow up

Introduction
Chronic stress can cause an imbalance within the autonomic nervous system, thereby affecting cardiovascular and mental health. Physical activity (PA) may have a positive effect on the autonomic nervous system and stress-related disorders, such as depression and burnout. Heart rate variability (HRV) is a non-invasive marker of the autonomic nervous system. However, limited and inconsistent data exist on the exact relationship between HRV, PA and depression and burnout symptoms. The HARMODI study aims to explore whether HRV is a feasible marker of depression and burnout symptoms and aims to evaluate the role of PA in the treatment of stress-related disorders.

Methods and analyses
This is an observational study with a cross-sectional up to 8 week follow-up study design. A total of 153 patients, undergoing psychiatric inpatient treatment with burnout syndrome (Z73) and depressive episode (F32 or F33) or adjustment disorder (F43.2), will be recruited. Data on depression and burnout symptoms, HRV recordings (24-hour, supine, standing and exercise stress test), cognitive function, cardiorespiratory fitness, cardiovascular health, balance and strength will be collected at baseline (T1) and after up to 8 weeks (T2). Continuous data on PA and Ecological Momentary Assessments of exhaustion, mood and tension will be monitored daily throughout inpatient treatment. Multiple regression models, adjusted for potential confounders, will assess the association between HRV as the primary outcome, PA and depression and burnout severity score.

Ethics and dissemination
The protocol has been approved by Swiss Ethics Committee, Cantonal Ethics Committee Zürich. Results of HARMODI will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number
NCT05874856.

Leggi
Giugno 2024

Incidence and predictors of diabetic foot ulcer among patients with diabetes mellitus in a diabetic follow-up clinic in Central Ethiopia: a retrospective follow-up study

Background
Diabetic foot ulcer is a major medical, social, and economic problem, and a leading cause of hospitalisations, increased morbidity, and mortality. Despite a rising occurrence, there is a dearth of data on the incidence and its predictors.

Objective
To assess the incidence and predictors of diabetic foot ulcers among patients with diabetes mellitus in a diabetic follow-up clinic in Central Ethiopia.

Design
Retrospective follow-up study design.

Participants
A total of 418 newly diagnosed diabetes mellitus patients from 1 January 2012 to 31 December 2022. A computer-generated simple random sampling method was used to select the study participants. Data were collected using a structured data extraction checklist. The collected data were entered into Epi Info V.7.2 and exported to STATA V.14 for analysis. To estimate survival time, the Kaplan-Meier method was used, and the survival difference was tested using a log-rank test.

Outcome measures
The Cox proportional hazard model was fitted to identify the predictors of diabetic foot ulcer development. The strength of the association was estimated using an adjusted hazard ratio (AHR) with a 95% confidence interval (CI), and statistical significance was proclaimed at a p

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Giugno 2024

Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study

Background
During adolescence, behaviours are initiated that will have substantial impacts on the individual’s short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available services are not always appropriate for their needs. We co-developed with adolescents a health and well-being check-up programme (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects and cost-effectiveness of Y-Check in three African cities.

Method
This is a multi-country prospective intervention study, with a mixed-method process evaluation. The intervention involves screening, on-the-spot care and referral of adolescents through health and well-being check-up visits. In each city, 2000 adolescents will be recruited in schools or community venues. Adolescents will be followed-up at 4 months. The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. Process and economic evaluations will investigate acceptability, feasibility, uptake, fidelity and cost effectiveness.

Ethics and dissemination
Approval has been received from the WHO (WHO/ERC Protocol ID Number ERC.0003778); Ghana Health Service (Protocol ID Number GHS-ERC: 027/07/22), the United Republic of Tanzania National Institute for Medical Research (Clearance No. NIMR/HQ/R.8a/Vol.IX/4199), the Medical Research Council of Zimbabwe (Approval Number MRCZ/A/2766) and the LSHTM (Approval Numbers 26 395 and 28312). Consent and disclosure are addressed in the paper. Results will be published in three country-specific peer-reviewed journal publications, and one multicountry publication; and disseminated through videos, briefs and webinars. Data will be placed into an open access repository. Data will be deidentified and anonymised.

Trial registration number
NCT06090006.

Leggi
Giugno 2024

Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial

Introduction
Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.

Methods and analysis
The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.

Ethics and dissemination
All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.

Trial registration number
ClinicalTrials.gov Registry (NCT04850300).

Leggi
Maggio 2024