Risultati per: Springer: Nuove riviste open access di Medicina Generale

Annals of Internal Medicine, Ahead of Print.

Background
To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.

Methods and analysis
A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.
After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq/L≤serum potassium (sK)

Introduction
The Central Chronic Medicines Dispensing and Distribution (CCMDD) programme, a differentiated alternative service delivery programme, initiated by the Department of Health, South Africa, allows clinically stable patients to receive chronic medication refills at the clinic-based or community-based pick-up points, offering stable patients suffering from non-communicable diseases an easy way to collect their medication. This facilitates the achievement of positive therapeutic outcomes and underscores the importance of this programme, which has resulted in decreased stigma concerns and optimising the workload for public health facilities and health workers. Therefore, this scoping review aims to explore and describe how the improved CCMDD programme has widened access to medications in South Africa in readiness for the implementation of the National Health Insurance.

Methods and analysis
This scoping review will be conducted using the Arksey and O’Malley framework and further refined by the Levac framework. The review will follow a six-step approach: (1) identifying the research question, (2) identifying relevant studies, (3) studying selection eligibility, (4) charting the data, (5) collating, summarising and reporting the results and (6) consultation. A comprehensive search strategy will be developed by searching studies published between 2014 and 2024 using the following electronic databases; PubMed, Web of Science and Google Scholar. Grey literature including conference abstracts and reports will also be searched. The Preferred Reporting Items for Systematic Reviews and the Meta-Analysis for Scoping Reviews (PRISMA-ScR) will be used as a guide for this scoping review protocol. Two independent reviewers will screen identified studies’ titles, abstracts and full texts. Discrepancies will be handled by consensus or consulting a third reviewer author. Data extraction will be conducted using a standardised form. The selection of studies for the review is anticipated to be completed within 10 weeks, from 15 March to 30 May 2025, with strict adherence to the guidelines of the PRISMA-ScR checklist.

Ethics and dissemination
This review, not requiring ethical approval, will inform policymakers, researchers and healthcare professionals to improve the deliverables of the CCMDD programme for all chronic conditions and ailments with a high prevalence in South Africa and identify any research gaps. We plan to disseminate our findings via a peer-reviewed journal, policy briefs, conference presentations and stakeholder engagement.

Iniziativa all’Università Politecnica delle Marche

Iniziativa all’Università Politecnica delle Marche

In the Original Investigation titled “Endometrial Thickness as Diagnostic Triage for Endometrial Cancer Among Black Individuals,” published online June 27, 2024, and in the August 2024 print issue, the article has been changed to a CC-BY open access license. Some updates to the authors’ Conflict of Interest Disclosures were also made. This article has been corrected.

Grinta, Continuerà nel solco tracciato dal dr. Zega

Introduction
Oligodendroglioma (ODG) is a rare type of brain tumour, typically diagnosed in younger adults and associated with prolonged survival following treatment. The current standard of care is maximal safe debulking surgery, radiotherapy (RT) and adjuvant procarbazine, lomustine and vincristine (PCV) chemotherapy. Patients may experience long-term treatment-related toxicities, with RT linked to impairments of neurocognitive function (NCF) and health-related quality of life (HRQoL). With proton beam therapy (PBT), radiation dose falls off sharply beyond the target with reduced normal brain tissue radiation doses compared with photon RT. Therefore, PBT might result in reduced radiation-induced toxicity compared with photon RT.

Methods and analysis
APPROACH is a multicentre open-label phase III randomised controlled trial of PBT versus photon RT in patients with ODG, investigating the impact of PBT on long-term NCF measured using the European Organisation for Research and Treatment of Cancer (EORTC) Core Clinical Trial Battery Composite (CTB COMP). The trial will randomise 246 participants from 18 to 25 UK RT sites, allocated 1:1 to receive PBT or photon RT, with PBT delivered at one of the two UK PBT centres. Participants with grade 2 and grade 3 ODG will receive 54 Gy in 30 fractions and 59.4 Gy in 33 fractions, respectively, followed by 6×6-weekly cycles of PCV chemotherapy. The trial contains staged analyses, with an internal pilot for feasibility of recruitment at 12 months, early assessment of efficacy at 2 years, futility assessment and final primary endpoint comparison of NCF between arms at 5 years. Secondary endpoints include additional NCF, treatment compliance, acute and late toxicities, endocrinopathies, HRQoL, tumour response, progression-free survival and overall survival.

Ethics and dissemination
Ethical approval was obtained from Newcastle North Tyneside REC (reference 22/NE/0232). Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines.

Trial registration number
ISRCTN:13390479.

Introduction
Intrauterine adhesions (IUAs) are one of the most common causes of uterine infertility. Hysteroscopic adhesiolysis is the primary treatment for IUA, but the rate of IUA recurrence is high in moderate to severe cases. While traditional guidelines recommend placing a non-copper stainless steel intrauterine device (IUD) into the uterine cavity after adhesiolysis to prevent readhesion, the preventive effect is uncertain. Our preliminary trials suggested that the collagen scaffold was more effective in moderate cases. This study aims to assess the efficacy and safety of a collagen scaffold versus IUD in preventing readhesion after hysteroscopic adhesiolysis in patients with moderate IUA.

Methods and analysis
This multicentre, open-label, randomised controlled trial evaluates the efficacy and safety of a collagen scaffold compared with an IUD in preventing readhesion after hysteroscopic adhesiolysis in women with moderate IUA. This trial will be conducted at six teaching hospitals and plans to enrol 200 participants. The primary outcome is the non-recurrence rate of IUA 2 months after adhesiolysis. Secondary endpoints include changes in American Fertility Society scores before and after surgery and postoperative menstrual blood volume. The 95% CIs for the difference in non-recurrence rates between the two groups will be calculated. If the lower limit of this interval exceeds the superiority threshold of zero, the conclusion of superiority is confirmed.

Ethics and dissemination
This study has received approval from the ethics committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School (2022-491-02) and the ethics committees of the participating centres. Written informed consent will be obtained from each participant before starting any study procedures. The results of this trial will be published in a peer-reviewed journal.

Trial registration number
ChiCTR2300068271.

Claessens Z, Fieuws S, Daems J, et al. Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020. BMJ Open 2025;15:e091361. doi:10.1136/bmjopen-2024–0 91 361
This article has been corrected since it was published online. Figure 4 of the paper has been updated from (lacking number of medicines included in conditional marketing authorisation)
to (including the number of medicines with conditional marketing authorisation)

Yang X, He X, Pan D, et al. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial. BMJ Open 2024;14:e091059. doi: 10.1136/bmjopen-2024091059 This article was previously published with an error. The follow-up visit at ‘48±12 hours’ was inadvertently omitted from ‘Follow-up Procedures’ under the Methods section. To accurately reflect all key assessment points, the text has been updated to: Study visits will occur at 24±12 hours, 48±12 hours, day 7±1 or at discharge (whichever occurs first), and day 90±7. The follow-up schedule is displayed in table 1. Accordingly, table 1 has been updated to include the missing ‘48±12 hours after randomisation’ visit, during which NIHSS scores, adverse event monitoring, and concomitant medication use are documented. The missing ‘48±12 hours’ follow-up visit has also been added to the timeline in figure 2, to align with…

Airo: “Radioterapia è speranza, serve integrazione specialisti”

Palliative care has become standard in many inpatient settings, with about three-quarters of US hospitals currently offering such services. Although early integration of palliative care can yield substantial benefits for patients and their caregivers (eg, enhanced quality of life, psychological well-being, improved coping), the optimal timing and best clinical settings for initiating palliative care are not yet established.

Introduction
Glaucoma is one of the most common causes of blindness and affects more than 70 million people worldwide. The disease is characterised by the loss of retinal ganglion cells associated with a progressive optic neuropathy, resulting in an impairment of visual functions, for example, visual field loss. Nowadays, the only modifiable risk factor is the increase in intraocular pressure, and its treatment is to lower this pressure by medication, laser treatment or surgery to avoid disease progression. New methods for preventing and reversing vision loss are thus urgently needed. Several small and two multicentre studies have presented evidence that repetitive transorbital alternating current stimulation (rtACS) can lead to long-lasting visual field improvement. This could open a new and inexpensive therapeutic option for optic atrophy. However, the level of evidence for this method is still fairly rather poor, and further trials are needed. Therefore, this clinical trial aims to prove the effectiveness of rtACS compared with sham stimulation in patients with primary open-angle glaucoma (POAG).

Methods and analysis
VIRON (Vision Restoration in Optic Neuropathy) is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with three arms. The primary objective is to assess the effectiveness of rtACS in patients with POAG compared with sham stimulation. The primary outcome is the change in mean defect (MD) in the visual field immediately after 10 sessions of rtACS (days 9, 16 and 23) compared with the values of initial perimetry (days –21 to –14 and 0) after applying electrical stimulation with a classical montage, compared with sham and electrical stimulation using individualised montage. Secondary outcome measures comprise a long-term effect with changes in MD at 24 weeks after stimulation, and data from the National Eye Institute Visual Function-25 and quality of life (Short Form 36) questionnaires. The target population are patients with glaucomatous optic atrophy and significant glaucomatous visual field defects (MD of 5–22 dB) due to POAG.
After randomisation, patients received either classical rtACS (group 1), individual rtACS (group 2) or sham stimulation (group 3) in daily 25 min stimulation sessions in two series of five consecutive days separated by a weekend interval. In group 1, active stimulation will be via the routinely applied montage using two electrodes affixed on the right and left side of the head, next to the eyes, with straightforward fixation. In group 2, the current flow will be individually modelled (MRI-based) to target areas of partial visual field defects by optimising electrode positions in conjunction with an optimised visual fixation direction. Group 3 with sham stimulation will serve as control.
The calculated sample size required to achieve a statistical power of 80% for a relevant effect size and allow for dropouts was 300 (100 per group). The trial has already begun with the first patient in July 2023. The planned recruitment period is 24 months with an estimated end of the study in November 2025 (last patient out). An adjusted extension of the study period is planned.

Ethics and dissemination
VIRON was approved by the Central Ethics Committee of the University Medical Center Göttingen (19 October 2022) and those of the individual participating centres (Bonn: 446/23-EP, Hamburg: 2023-200889-BO-bet, Cologne: 23-1487 and Mainz: 2023-17399-§23b). The study protocol complies with the Declaration of Helsinki, the national medicine device regulation (MDR) laws and the international standards of good clinical practice (GCP).
The study protocol (V.5, 24 November 2023) was designed following the Standard Protocol Items: Recommendations for Interventional Trials guidelines and is registered on https://drks.de/search/de/trial/DRKS00029129.
As study initiatior the University Medical Center Göttingen (UMG) is responsible for data ownership and data management of the VIRON study. The study data will be published within 6 months of the study being completed. After the publication of the primary results, all data are anonymised and published in an open-access journal to ensure access to the data for third parties.

Trial registration number
https://drks.de/search/de/trial/DRKS00029129.

In patients hospitalised for COVID-19 receiving ventilatory support, we found no evidence that higher dose corticosteroids reduced the risk of death compared to usual care, which included low dose corticosteroids.

Objectives
To explore the barriers to accessing quality trauma care after injury in Ghana.

Design
A qualitative study using semi-structured interviews and focus group discussions in one rural and one urban setting. Interviews and focus group discussions were audio recorded, transcribed and thematically analysed using the four-delay framework.

Participants
53 patient participants (n=39 men, n=14 women, mean age=41, SD=15.6, n=38 rural participants, n=15 urban participants) who had an injury not more than 6 months preceding the start of the study.

Settings
15 individual interviews (n=15) and 2 focus group discussions (n=23) were conducted in Yendi (rural setting in Ghana) and 10 individual interviews (n=10) and 1 focus group discussion (n=5) in the Tamale metropolis (urban setting in Ghana).

Results
Our findings showed that when an injury occurred, participants faced multiple barriers across all delays which prevented them from accessing quality injury care. Barriers were a mix of individual, community-level and health-system factors that were interrelated in many ways. Financial difficulties were one of the prominent barriers mentioned by the participants in both settings.

Conclusion
This study shows that multiple factors cause an injured patient to delay in seeking care, reaching care, receiving care and remaining in care. Therefore, there is a pressing need for comprehensive, community-driven strategies to strengthen health literacy at the community level. There is also a need for facility-based strategies that would improve the availability of medical and human resources to augment access to quality trauma care. Additionally, if policymakers focus on removing financial barriers to trauma care and strengthening referral systems, especially in the remote and rural areas, it would greatly improve access to quality trauma care in Ghana.