Access to dental services for children: a scoping review on the impact of COVID-19 and implications for future models of care

Background
The COVID-19 pandemic had detrimental effects on routine health and social care as countries instituted widespread public health measures to control transmission of SARS-CoV-2. This affected care delivery for many chronic and non-communicable diseases, including oral health and dental diseases with implications in the postpandemic period.

Objectives
This scoping review, conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Scoping Review guidelines, aims to synthesise evidence regarding the impact of COVID-19 on access to dental services among children and their implications for future models of care, especially for children from low-income families, to inform policy decision making around subsidised dental services in Australia.

Data sources
PubMed, Web of Science, Embase, Cochrane Library of Systematic Reviews and Cochrane Central Register of Controlled Trials.

Eligibility criteria
Primary studies of any design published between 1 January 2020 and 31 July 2024. Included studies described provision of paediatric dental services, considered components of access or utilisation and were published in English. Excluded studies were those that only evaluated maxillofacial services.

Data extraction and synthesis
Data were extracted using a standardised template in MS Excel then analysed to thematically classify findings based on key areas of impact. Quality assessment of studies was not conducted.

Results
54 articles from 17 countries were included. Studies identified reductions in service availability and utilisation, including patient and parent-driven demand. Changes to the configuration of services included greater rates of emergency treatment, reductions in use of aerosol-generating procedures and more use of teledentistry, as well as self-management and prevention approaches. Substantial delays to routine dental care, leading to more dental problems and ongoing need, especially untreated dental caries, were observed with a disproportionate impact on socioeconomically disadvantaged and vulnerable children and families.

Conclusion
The COVID-19 pandemic has had pronounced negative effects on the provision of primary and secondary dental care for children around the world. Access to care was affected by disruptions to service availability and by changes in demand for services related to parental anxiety around the risk of COVID-19 transmission. Delays in receipt of routine dental care and changes to oral health behaviours are likely to lead to an increased need for oral health services, with service adaptations needed to ensure this increased demand can be met.

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Maggio 2025

Revisiting the Open Vein Hypothesis to Reduce the Postthrombotic Syndrome: Implications for Multidisciplinary Care and Research: A Scientific Statement From the American Heart Association

Circulation, Ahead of Print. The “open vein hypothesis” postulates that early thrombus clearance and restoration of venous blood flow may prevent postthrombotic syndrome after proximal deep vein thrombosis. Since its proposal several decades ago, new insights from basic and clinical studies have motivated a re-evaluation and refinement of this hypothesis. According to data from these studies, susceptibility to postthrombotic syndrome occurs as a result of differences in genetic composition, thrombophilic conditions, predilection to inflammation and fibrosis, endogenous fibrinolytic capability, timing of s ymptom presentation and treatment initiation, and efficacy of antithrombotic therapy. Although initial restoration of an open vein appears to be beneficial for selected patient groups, freedom from postthrombotic syndrome is more likely in the setting of long-term venous patency, reduced recurrent thrombotic episodes, and reduced perithrombotic (eg, vein wall and valve) inflammation. These underlying biological mechanisms need further elucidation, with a long-term goal of personalizing treatment by mapping the individuals’ clinical presentation with their underlying risk factors and assessing time-dependent biological processes that occur as a clinical venous thrombosis resolves. This scientific statement (1) highlights historical fundamentals of the open vein hypothesis and then showcases new research insights into the pathophysiological factors driving postthrombotic syndrome; (2) discusses advantages and disadvantages of imaging modalities for deep vein thrombosis used in clinical practice, including the potential to depict thrombus chronicity and status of vein wall injury; (3) proposes measures to develop integrated multidisciplinary care for deep vein thrombosis focused on the reduction of postthrombotic syndrome; and (4) identifies priority areas and questions for further research.

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Maggio 2025

Effects of early factor XIII replacement in postpartum hae morrhage: study protocol for a multicentre, open-label, randomised, controlled, investigator-initiated trial

Introduction
The primary objective of this trial is to evaluate the effect of replenishing coagulation factor XIII (FXIII) in women with postpartum haemorrhage (PPH) on measured blood loss (MBL). Based on earlier research, we hypothesise that the administration of FXIII leads to a significant reduction in postpartum blood loss.

Methods and analysis
This is a randomised, controlled trial that will allocate eligible patients in the event of a PPH and after receiving tranexamic acid either to the treatment group, receiving FXIII, or to the control group (standard of care). The primary endpoint is the MBL within 24 hours using a standardised method. For the primary analysis, estimation of the OR under a proportional odds assumption is conducted simultaneously for all possible cut-off points. A corresponding estimate, along with a two-sided 95% CI and two-sided p value against the null hypothesis OR=1, is obtained from the Continuous Outcome Logistic Regression model. More than 7000 patients will be screened in order to include a total of 988 eligible patients into the trial. Secondary outcomes include the rate of adverse maternal outcomes related to PPH, the rate of women breastfeeding after PPH and the safety of the administration of FXIII in women with PPH. Dynamics of blood coagulation factors in women with PPH and their association with MBL will be assessed in specific centres. A preliminary overview on costs and potential savings through early treatment of PPH with FXIII is included in the analysis as well as a patient and public involvement report, asking for patients’ personal experience during PPH in the main study centre.

Ethics and dissemination
Ethics approval was granted by the central ethics committee (Kantonale Ethikkommission Zürich/Switzerland) on 16 June 2024, reference number: BASEC 2024-00374. Results will be disseminated via open-access publication in a relevant medical journal.

Trial registration number
ClinicalTrials.gov ID NCT06481995.

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Maggio 2025

PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter, open-label, randomised conTrolled studY (PROSPERITY)

Introduction
Loop ileostomy and loop colostomy are both used to form a protective stoma after anterior resection. Evidence regarding which of these two procedures is superior is lacking. Furthermore, no studies comparing changes in the microbiome after loop ileostomy or loop colostomy exist.

Methods and analysis
This multicentre, open-label, superiority, individually randomised controlled trial will include patients who undergo anterior rectal resection with primary anastomosis with a protective stoma. The exclusion criteria are patients who already have a stoma, technical inability to create either type of stoma, aged

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Maggio 2025

A phase I, open-label, multicentre, first-in-human study to evaluate safety, pharmacokinetics and efficacy of AMG 404, a PD-1 inhibitor, in patients with advanced solid tumours

Objective
To evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumour activity of AMG 404, a fully human IgG1 monoclonal antibody targeting programmed cell death-1, in patients with advanced solid tumours.

Design
First-in-human phase I study comprising eight dose expansion cohorts, including cohorts with microsatellite instability-high (MSI-H) tumours and non-small cell lung cancer with high programmed death-ligand 1 expression (NSCLC/PDL1-H, tumour proportion score ≥50%).

Setting
Conducted across 28 global sites.

Participants
This study enrolled adult patients with histologically or cytologically confirmed metastatic or locally advanced solid tumours not amenable to curative treatment with surgery or radiation. The inclusion criteria included a life expectancy of >3 months, ≥1 measurable or evaluable lesion per modified Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1, an Eastern Cooperative Oncology Group performance status of ≤2 and adequate haematological, renal and hepatic function. Patients with prior treatment with checkpoint inhibitors, primary brain tumour or untreated or symptomatic brain metastases and leptomeningeal disease and history of other malignancy within the past 2 years were excluded.

Interventions
The planned doses were 240 mg, 480 mg and 1050 mg of AMG 404 administered every 4 weeks (Q4W).

Primary and secondary outcome measures
Primary endpoints were dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, changes in vital signs and clinical laboratory tests. Secondary endpoints included PK parameters, incidence of antidrug (AMG 404) antibodies and antitumour activity assessed per modified RECIST V.1.1 (objective response, duration of response, progression-free survival (PFS), disease control and duration of stable disease).

Results
A total of 171 patients were enrolled; 168 were treated. Median (range) follow-up was 36.3 weeks (1.6–137.1). No DLTs were observed. Grade 3 and serious treatment-related adverse events occurred in 16 (9.5%) and 12 (7.1%) patients, respectively. The 480 mg Q4W dose was selected as the recommended phase II dose. AMG 404 serum exposure increased approximately dose proportionally. The objective response rate (80% CI) was 19.6% (15.7–24.1) for the overall population and 36.6% (26.4–47.8) and 30.8% (14.2–‍52.3) for cohorts with MSI-H tumours (n=41) and NSCLC/PDL1-H (n=13), respectively. The overall disease control rate (80% CI) was 54.8% (49.5–59.9). The median (80% CI) PFS was 3.7 (3.5–4.5) months for the overall population and 14.8 (9.0–not estimable) and 4.4 (2.2–9.7) months for cohorts with MSI-H tumours and NSCLC/PDL1-H, respectively.

Conclusions
AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types.

Trial registration number
NCT03853109.

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Maggio 2025

Change to Open Access Status

The Original Investigation titled “An Approach to Providing Timely Mental Health Services to Diverse Youth Populations,” published online February 26, 2025, was changed to open access status under a CC-BY license. This article was corrected online.

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Maggio 2025