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Hoy — Diciembre 16th 2025Tus fuentes RSS

Efficacy and safety of microbiota-targeted therapeutics in autoimmune and inflammatory rheumatic diseases: protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Kragsnaes · M. S. · Gilbert · B. T. P. · Sofiudottir · B. K. · Rooney · C. M. · Hansen · S. M.-B. · Mauro · D. · Mullish · B. H. · Bergot · A.-S. · Mankia · K. S. · Goel · N. · Bakland · G. · Johnsen · P. H. · Miguens Blanco · J. · Li · S. · Dumas · E. · Lage-Hansen · P. R. · Wagenaar
Introduction

An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.

Methods and analysis

This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.

Ethics and dissemination

No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.

PROSPERO registration number

CRD42025644244.

AnteayerTus fuentes RSS

Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Comparative analysis of HIV data completeness in Haitis iSante Plus Electronic Medical Record system across children, adolescents and adults: a cross-sectional evaluation of 2016-2022 data

Por: Odeny · B. · Honore · J. G. · Balan · J. G. · Hughes · J. P. · Wagenaar · B. · Gloyd · S. · Celestin · K. · Elisma · M. · Francois · K. · Puttkammer · N.
Objective

To evaluate and compare documentation completeness of HIV-related data by age group (children, adolescents and adults) in Haiti’s Electronic Medical Record (EMR) system.

Design

Cross-sectional evaluation.

Setting

EMR data for 36 965 enrolment visits, and 123 608 return visits from 58 facilities in Haiti (from 2016 to 2022).

Participants

Children, adolescents and adults accessing HIV care and treatment services in Haiti.

Main exposure measure

Health facility attendance for HIV-related healthcare.

Main outcome measure

Level of data completeness, as a measure of data quality. We developed Composite Completeness Scores (CCS scores) to measure data completeness. Lower scores meant lower completeness. Generalised linear models were used to investigate factors associated with completeness.

Results

At the enrolment visit, most patients were adults (81.6%) and female (56.7%). Most facilities were health centres (75.9%). The overall average enrolment visit CCS score was 54.0%. At enrolment, being a child (CCS score difference=–7.08, 95% CI: –11.31 to –2.86) and a more recent year of enrolment (–6.01, 95% CI: –11.69 to –0.33) were significantly associated with lower completeness scores than being an adult and having an earlier year of enrolment, respectively. The overall average return visit CCS score was 49.6%. At the return visit, children (–6.76, 95% CI: –10.07 to –3.45) had significantly lower average completeness scores than adults. For first viral load documentation, children had lower odds of completeness compared with adults (adjusted OR=0.21, 95% CI: 0.16 to 0.28). Sex, year of enrolment, facility ownership (public, private, mixed), total patient volume and duration of EMR use were not significantly associated with completeness of documentation at the enrolment and return visits.

Conclusions

We observed disparities in electronic data completeness by age group, which may be indicative of digital health disparities. Documentation was particularly poor among children and declined over time for enrolment visits. Further research is needed to understand and address these documentation gaps.

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