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Natural history, clinical outcomes and predictors of disease course in paediatric IgA vasculitis: protocol for a multicentre prospective cohort study in Guangxi Zhuang Autonomous Region, China

Por: Jiang · H.-H. · Meng · X.-Y. · Liang · Q. · Li · R.-J. · Tang · Q. · Huang · L. · Yun · X. · Shan · Q.-W. · Chen · X.-Q.
Introduction IgA vasculitis (IgAV, formerly Henoch-Schönlein purpura) is a systemic small-vessel vasculitis. The aetiology of IgAV is multifactorial, involving environmental triggers in genetically susceptible individuals. Evolving socioeconomic and environmental factors may be altering the contemporary aetiological and precipitant spectrum of IgAV. Prospective observational studies are therefore crucial for elucidating disease management, prognostic factors and long-term outcomes. Although numerous studies exist on paediatric IgAV, prospective cohort data remain limited. This multicentre prospective observational study aims to characterise the natural history, aetiological/precipitant spectrum, incidence and outcomes of gastrointestinal and renal involvement, factors influencing therapeutic efficacy and the predictive value of biomarkers for disease activity.

Methods and analysis

We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.

Trial registration number

ChiCTR2500099716.

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures

Por: Kotcher · R. E. · Rosengart · M. R. · La Colla · L. · Lin · H.-H. S. · Vogt · K. M. · Xu · Y. · Neal · M. D.
Introduction

Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.

Methods and analysis

This is a randomised controlled trial in which adult trauma inpatients (18 years) with painful rib fractures will be allocated 1:1:1 to three arms: bright blue light intervention (peak 442 nm, ~1400 lux), bright full-spectrum light comparison (~1400 lux) and usual ambient light control. Bright light exposures will be administered for 4 consecutive hours daily for up to 3 days. The primary outcome will be any measurable changes in chest wall pain intensity during deep breathing, quantified using an 11-point Numerical Rating Scale. Secondary outcomes will assess chest wall pain intensity at rest, opioid requirements, delirium incidence, pulmonary complication incidence, hospital-free and intensive care unit-free days, and physiological markers of autonomic nervous system, circadian, and immune activation. Sample size analysis yields a total of 75 participants needed to detect a 2-point difference in pain scores with >80% power and assuming a 20% non-completion rate.

Ethics and dissemination

Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.

Trial registration number

NCT06626334.

Associations between patient characteristics and five-year trajectories of anticholinergic drug burden in older adults in German primary care: a prospective observational cohort study

Por: Tajdar · D. · Westphal · J. · Lühmann · D. · Krüger · C. · Langebrake · C. · Bickel · H. · Fuchs · A. · Gensichen · J. · König · H.-H. · Maier · W. · Mergenthal · K. · Riedel-Heller · S. G. · Schön · G. · Weyerer · S. · Wiese · B. · Scherer · M. · Schäfer · I.
Objectives

To investigate the change in anticholinergic burden over a 5 year period in relation to the health characteristics of older adults.

Study design

Using data from the MultiCare Cohort Study (2008–2013), a prospective observational cohort study based on patient data from 158 general practices

Setting

Primary care in Germany.

Participants

3189 multimorbid adults aged 65 to 85 years

Primary and secondary outcome measures

The primary outcome was the change in the anticholinergic burden score (ACB) over a 5 year period. The ACB was defined as the dependent variable and was calculated by including all anticholinergic drugs prescribed to participants during the study period. Independent variables included age, sex, education (according to CASMIN), depressiveness (GDS), cognitive function (LDST), quality of life (EQ5D-3L) and the number of diseases weighted by severity. We performed multilevel mixed-effects multivariable linear regression analyses.

Results

A total of 7068 observations were analysed during three follow-ups. The mean age of the participants was 74.4±5.2 years and 59.3% were female. The mean ACB score was 1.5±1.7 at baseline and did not change significantly over time. In contrast, a higher severity-weighted number of diseases (coefficient: 0.08, 95% CI: 0.05/0.10, p

Conclusions

Our results show that anticholinergic prescribing increases despite the deteriorating health status of older adults, which may lead to higher hospitalisation and mortality rates. New practice recommendations for general practitioners may be helpful in raising their awareness of cumulative ACB and enabling them to discontinue or reduce the dose of some anticholinergics where possible. However, further research is needed to assess the impact of our findings on prescribing behaviour in primary care.

Trial registration number

ISRCTN89818205.

Excess costs of transgender and gender-diverse people with gender incongruence and gender dysphoria compared with people from the general population in Germany: a secondary analysis using data from a randomised controlled trial and a representative teleph

Por: Grochtdreis · T. · König · H.-H. · Konnopka · A. · Dekker · A. · Briken · P. · Renner · J. · Nieder · T. · Dams · J.
Objectives

For transgender and gender-diverse (TGD) people, it is known that there is a lack of healthcare professionals with experience in trans healthcare. This may result in either inadequate provision of healthcare or in an increased seeking of adequate trans healthcare. Little is known about healthcare services utilisation and resulting costs in treatment-seeking TGD people with gender incongruence or gender dysphoria (GIC/GD). Therefore, the aim of this study was to determine the excess costs associated with GIC/GD in Germany.

Design

In a secondary analysis, baseline data of a randomised controlled trial with a sample of TGD people with GIC/GD were combined with data of a telephone survey conducted in a representative sample of the general German population. The data sets were matched using entropy balancing. Self-reported healthcare services utilisation was valued by standardised unit costs for the German healthcare system, and absenteeism from work and unemployment were valued with the gross hourly wage of persons in manufacturing and services sectors.

Settings

TGD people with GIC/GD living at least 50 km outside Hamburg in the federal state Bremen, Mecklenburg-Western Pomerania, Lower Saxony or Schleswig Holstein and the German general adult population.

Participants

Treatment-seeking TGD people with GIC/GD (n=167) and people of the general German population (n=2811).

Primary and secondary outcome measures

6-month excess healthcare costs and indirect costs from a societal perspective were calculated for the year 2020 using two-part models with logit specification for the first part and a generalised linear model with gamma family and log link function for the second part.

Results

The total 6-month excess costs associated with GIC/GD from a societal perspective were estimated to be 672 (95% CI: –3315 to 4657; p=0.741) per person. The direct excess healthcare costs were estimated to be 2 (–1115 to 1119; p=0.977) and the indirect excess costs due to absenteeism from work and unemployment were 669 (–3031 to 4370; p=0.723) per person. The total excess costs associated with GIC/GD in trans men, trans women and non-binary people were estimated to be –5572 (–12 232 to 1088), 4238 (–1694 to 10 170) and 3041 (–4268 to 10 351) per person (all with p>0.05), respectively.

Conclusions

The total 6-month costs in TGD people with GIC/GD did not differ statistically significantly from the costs in the general German population. Indirect excess costs due to absenteeism from work accounted for the largest part of the excess costs associated with GIC/GD, yet with wide 95% CIs. Potential causes of absenteeism from work, such as experienced or expected discrimination, need to be identified and addressed so that TGD people can experience a healthy work environment.

Trial registration number

NCT04290286.

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