Risultati per: Cardio-oncology: rivista open access

Introduction
The reduction of fluoroscopic exposure during catheter ablation of supraventricular arrhythmias is widely adopted by experienced electrophysiology physicians with a relatively short learning curve and is becoming standard of care in many parts of the world. While observational studies in the USA and some parts of Western Europe have evaluated the minimal fluoroscopic approach, there are scarce real-world data for this technique and generalisability of outcome in other economic regions.

Methods and analysis
The arrhythmias with as low as reasonably achievable X-ray exposure study is a prospective, observational, multicentre and multinational open-label registry study. Up to 700 patients undergoing catheter ablation for right-sided supraventricular arrhythmias (according to national guidelines) will be enrolled for the routine use of the EnSite Precision 3D mapping system. Participating sites are distributed in 13 countries from Central Eastern Europe, North and South Africa, the Middle East and the CIS (Commonwealth of Independent States), with different levels of expertise using minimal fluoroscopic exposure techniques. After electrophysiological procedure, patients will be followed up for 6 months either in-clinic or via telephone interview. Patients will be asked to complete a study questionnaire at enrolment and 6 months after the invasive procedure to assess quality of life changes secondary to the procedure. The study’s primary objective is to describe ionising radiation exposure during catheter ablation when the EnSite Precision 3D mapping system is used in supraventricular tachycardia ablation. The study’s secondary objective is to assess the safety and efficacy of this method. Furthermore, fluoroscopy timing, total procedure time, success rate and complications will be reported.

Ethics and dissemination
The study was approved by the ethics committee at Mohammed Bin Khalifa Specialist Cardiac Centre (BDF/R&REC/2020-504) and the medical ethics committees of all participating sites. Participants will be required to provide informed consent before enrolment in the study. The study results will be published and presented at conferences.

Trial registration number
NCT04716270

Introduction
BedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects.

Methods and analysis
Design: Prospective parallel randomised, open-label, blinded end-point trial.
Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.
Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.
Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.
Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.
Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.
Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.
Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).
Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.
Sample size: The trial will continue until a projected 368 primary outcome events have occurred.
Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years).

Ethics and dissemination
BedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal.

Trial registration number
NCT04054648.

Introduction
Monkeypox was originally endemic locally in West Africa; however, outbreaks in non-endemic countries have been recognised since May 2022. The effectiveness of tecovirimat has been estimated against smallpox, which belongs to the same Orthopoxvirus genus as monkeypox. Thus, tecovirimat is expected to be effective against monkeypox. This study aims to evaluate the efficacy and safety of oral tecovirimat therapy for patients with smallpox and monkeypox and to prepare a scheme for oral tecovirimat use in Japan.

Methods and analysis
This nationwide, multicentre, non-randomised, open-label, double-arm study will involve viral examination of the blood, throat swabs, urine and skin lesions, performed periodically. Participants will freely decide whether to participate in an administered group (supportive treatment plus oral tecovirimat) or a non-administered group (only supportive treatment). Tecovirimat will be administered for 14 days. To ensure that financial problems do not preclude participation in the study, the research fund will cover the cost of tecovirimat and basic hospitalisation fees. The primary endpoint is the percentage of patients with negative PCR results (cycle threshold value ≥40) for skin lesion specimens at 14 days after inclusion in the study. Secondary endpoints include mortality at 14 and 30 days, viral load in each sample, duration of fever and adverse events. The sample size is estimated to be 50 patients with monkeypox or smallpox.

Ethics and dissemination
Written informed consent will be obtained from all participants. This study was approved by the Certified Review Board of National Center for Global Health and Medicine and published in the Japan Registry of Clinical Trials. The results of this study will be published in peer-reviewed journals and/or in presentations at academic conferences.

Trial registration number
jRCTs031220169.

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

This Viewpoint argues that making a progestin-only contraceptive pill available for sale as an over-the-counter product will help reduce logistic barriers to safe and effective birth control.

The Original Investigation titled “Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs Paclitaxel Alone in Patients With Platinum-Resistant Ovarian High-Grade Serous Carcinoma: The OCTOPUS Multicenter, Phase 2, Randomized Clinical Trial,” published online March 16, 2023, in the May 2023 print issue, has changed license status to open access (CC-BY-NC-ND license). This article has been updated online.

This Viewpoint explains the history of the Comstock Act, its use by those seeking to restrict abortion, and why it threatens abortion access in the US.

Annals of Internal Medicine, Ahead of Print.

Introduction
Colistin is a lipopeptide antibiotic administered as an inactive prodrug—colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, dependent on plasma concentrations. The number of patients with infections caused by multidrug-resistant Gram-negative bacteria sensitive only to colistin and the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure increased significantly in association with COVID-19-induced infections. ECMO can generally affect the pharmacokinetics of drugs by creating a new compartment.

Methods and analysis
The COL-ECMO2022 study is a prospective, non-randomised, single-centre, phase IV pharmacokinetic clinical trial designed to assess the influence of ECMO on the pharmacokinetics of colistin and CMS. Up to 30 patients treated with colistin will be included in the study and assigned to one of two arms, depending on the presence/absence of ECMO. All study participants will receive standard CMS dose intravenously. The plasma concentrations of colistin and CMS taken at defined intervals will be assessed by high-performance liquid chromatography-mass spectrometry. Patients will participate in the clinical trial for a maximum of three monitored dosing intervals. A population pharmacokinetic model will be developed to assess the influence of ECMO on pharmacokinetics. A difference greater than 25% is considered clinically significant.

Ethics and dissemination
The study has been approved by the Ethics Committee of St. Anne’s University Hospital Brno (Number 10ML/2022-AM). Related manuscripts will be submitted to peer-review journals.

Trial registration numbers
EudraCT Number 2022-000291-19; NCT05542446.

New England Journal of Medicine, Ahead of Print.

Introduction
Patients with cancer undergoing chemotherapy experience various physical and psychological problems and discomfort. Virtual reality (VR) can be used in technology-based non-pharmacological therapy that can serve as a potential distractor in the symptom management of patients with cancer undergoing chemotherapy. We propose a smartphone-based virtual reality relaxation (S-VR) technique as a complementary modality to provide comfort to patients with cancer, and we will evaluate its effect on patients with cancer undergoing chemotherapy.

Methods and analysis
We will recruit 80 patients from the One Day Chemotherapy ‘Tulip’ Center of Dr. Sardjito General Hospital, Yogyakarta, Indonesia. This will be a two-arm parallel randomised controlled trial, with a 1:1 allocation and the primary outcome assessor blinded. This study will be divided into two groups: (1) an intervention group, with participants receiving 360° panoramic video content and music relaxation intervention through a VR device (head-mounted display) placed on their head during chemotherapy for ±10 min plus standard care and (2) a control group, with participants receiving guided imagery relaxation therapy in the form of a leaflet plus standard care. We will measure the outcomes after one chemotherapy cycle for each participant. The primary outcome is the effectiveness of the S-VR in improving the comfort of patients. The secondary outcome is the effect of the S-VR on the patients’ symptom management self-efficacy, pain, anxiety, blood pressure (systolic blood pressure and diastolic blood pressure) and pulse rate.

Ethics and dissemination
This study was approved by the Medical and Health Research Ethics Committee of the Faculty of Medicine, Public Health and Nursing of Universitas Gadjah Mada—Dr. Sardjito General Hospital, Yogyakarta, Institutional Review Board (approval number: KE/FK/0301/EC/2023). Written informed consent will be obtained from all participants who enrol in the study. Dissemination will be conducted through peer-reviewed publications and conference presentations.

Trial registration number
NCT05756465.

This study estimates changes in geographic access and drive times to gender clinics following legislation enacted to restrict puberty-suppressing medications and hormones for those younger than 18 years.

Introduction
Guided tissue regeneration (GTR) combined with bone grafting for periodontal regenerative surgery has ideal clinical results for intrabony defect. However, some sites of intrabony defects often suffer from insufficient keratinised gingival width, which affects the efficacy and long-term prognosis of periodontal tissue regeneration. Free gingival graft (FGG) is an effective surgical procedure to widen the keratinised gingiva, but there are few clinical studies on FGG prior to GTR combination with bone grafting to improve clinical outcomes.

Methods
This study is an open-label randomised controlled trial. 68 patients with periodontitis with at least one intrabony defect depth with ≥3 mm are recruited and randomly grouped. In the test group, FGG is performed first, followed by GTR and bone grafting 3 months later; while in the control group, only periodontal tissue regenerative procedures are performed. After completion of all procedures, the patients will be recalled at 3 months, 6 months and 12 months and the relevant clinical and radiographic examinations will be carried out and statistical analysis of the data will also be performed. The present research has received approval from the Ethics Committee of Shanghai Stomatological Hospital (No.2022–007) on 4 August 2022.

Discussion
Exploring the effectiveness of the two-stage approach of FGG prior to periodontal tissue regenerative surgery for the treatment of keratinised gingival width deficient intrabony defects can provide a high-level evidence-based basis for the formulation of relevant treatment strategies in clinical practice.

Ethics and dissemination
The present research has received approval from the Ethics Committee of Shanghai Stomatological Hospital (No.2022–007) on 4 August 2022. The patients will be incorporated into this trial only after their written informed consent has been obtained. The study will be performed according to the 2013 revision of the Helsinki Declaration of 1975. Personal information of all subjects will be stored in the Department of Periodontology of Shanghai Stomatological Hospital. Data of the present research will be registered with the Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific journals.

Trial registration
Chinese Clinical Trial Registry, ID: ChiCTR 2200063180. Registered on 1 September 2022.

Objective
This study compares the use of sickness absence benefits (SABs) due to a common mental disorder (CMD) between precariously employed and non-precariously employed workers with CMDs.

Design
Register-based cohort study.

Participants
The study included 78 215 Swedish workers aged 27–61 who experienced CMDs in 2017, indicated by a new treatment with selective serotonin reuptake inhibitors (SSRIs). Excluded were those who emigrated or immigrated, were self-employed, had an annual employment-based income 90 days of unemployment per year, had student status, had SABs due to CMDs during the exposure measurement (2016) and the two previous years, had an SSRI prescription 1 year or less before the start of the SSRI prescription in 2017, had packs of >100 pills of SSRI medication, had a disability pension before 2017, were not entitled to SABs due to CMDs in 2016, and had no information about the exposure.

Outcome
The first incidence of SABs due to CMDs in 2017.

Results
The use of SABs due to a CMD was slightly lower among precariously employed workers compared with those in standard employment (adjusted OR [aOR] 0.92, 95% CI 0.81 to 1.05). Particularly, women with three consecutive years in precarious employment had reduced SABs use (aOR 0.48, 95% CI 0.26 to 0.89), while men in precarious employment showed weaker evidence of association. Those in standard employment with high income also showed a lower use of SABs (aOR 0.74, 95% CI 0.67 to 0.81). Low unionisation and both low and high-income levels were associated with lower use of SABs, particularly among women.

Conclusions
The study indicates that workers with CMDs in precarious employment may use SABs to a lower extent. Accordingly, there is a need for (1) guaranteeing access to SABs for people in precarious employment and/or (2) reducing involuntary forms of presenteeism.

Introduction
Matching-adjusted indirect comparison (MAIC) studies are a subtype of indirect comparison, which uses propensity score weighting to enhance comparability. This method adjusts aggregated data based on covariables from individual patient data from studies to produce population-adjusted indirect comparisons. Some national Health Technology Assessment agencies have recently received submissions containing MAIC models. However, there can be a lack of confidence in its estimates when they are poorly reported and inconsistent with other techniques. The objective of this study is to map the characteristics, concepts and methodology of MAIC studies used for pharmacological therapies in the field of oncology.

Methods and analysis
A scoping review methodology will be applied following the Joanna Briggs Institute framework and the results will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews. Studies that used MAIC to compare treatments in oncology conditions will be considered eligible. A systematic search will be conducted in PubMed, Embase and the Cochrane Library. No restriction of location or language will be applied. Study screening will be documented and presented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow diagram. Data will be extracted and recorded on a predefined data form and will be presented in a tabular form accompanied by a descriptive summary.

Ethics and dissemination
No ethical approval is required for this study. The results of this scoping review will be disseminated through peer-reviewed publications.

This study examines the exposure of Medicare Part D beneficiaries to utilization management, such as prior authorization, for oral oncology drugs.