Risultati per: Cardio-oncology: rivista open access

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.

Circulation, Ahead of Print. BACKGROUND:ST-segment–elevation myocardial infarction (STEMI) guidelines recommend pharmaco-invasive treatment if timely primary percutaneous coronary intervention (PCI) is unavailable. Full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. Whether pharmaco-invasive treatment with half-dose tenecteplase is effective and safe in older patients with STEMI is unknown.METHODS:STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction) was an investigator-initiated, open-label, randomized, multicenter study. Patients ≥60 years of age with ≥2 mm ST-segment elevation in 2 contiguous leads, unable to undergo primary PCI within 1 hour, were randomly assigned (2:1) to half-dose tenecteplase followed by coronary angiography and PCI (if indicated) 6 to 24 hours after randomization, or to primary PCI. Efficacy end points of primary interest were ST resolution and the 30-day composite of death, shock, heart failure, or reinfarction. Safety assessments included stroke and nonintracranial bleeding.RESULTS:Patients were assigned to pharmaco-invasive treatment (n=401) or primary PCI (n=203). Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively. After last angiography, 85.2% of patients undergoing pharmaco-invasive treatment and 78.4% of patients undergoing primary PCI had ≥50% resolution of ST-segment elevation; their residual median sums of ST deviations were 4.5 versus 5.5 mm, respectively. Thrombolysis In Myocardial Infarction flow grade 3 at last angiography was ≈87% in both groups. The composite clinical end point occurred in 12.8% (51/400) of patients undergoing pharmaco-invasive treatment and 13.3% (27/203) of patients undergoing primary PCI (relative risk, 0.96 [95% CI, 0.62–1.48]). Six intracranial hemorrhages occurred in the pharmaco-invasive arm (1.5%): 3 were protocol violations (excess anticoagulation in 2 and uncontrolled hypertension in 1). No intracranial bleeding occurred in the primary PCI arm. The incidence of major nonintracranial bleeding was low in both groups (

New England Journal of Medicine, Volume 389, Issue 2, Page 179-181, July 2023.

Introduction
Percutaneous coronary intervention (PCI)-related myocardial infarction (type 4a MI) and major periprocedural myocardial injury have been demonstrated leading to poor prognosis of patients with coronary heart disease (CHD) undergoing elective PCI and still remain high occurrence even after the therapy of dual antiplatelet agents and statins. Proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has been shown to be effectively in reducing the risk of acute MI (AMI). However, the effect of alirocumab on preventing PCI-related MI or major periprocedural myocardial injury in patients with CHD undergoing elective PCI remains uncertain.

Methods and analysis
Alirocumab effect on Preventing Periprocedural ischaemic Events in coronary heart diseAse patients undergoing coronary StEnting trial is a multicentre, open-label, randomised controlled trial aiming to determine whether alirocumab could reduce the incidence of type 4a MI or major periprocedural myocardial injury in patients with CHD undergoing elective PCI. In total, 422 non-AMI CHD patients planned to undergo elective PCI will be randomly assigned to receive standard pharmacotherapy of CHD (control group) or additional use of subcutaneous alirocumab 75 mg 1 day before procedure (alirocumab group). The primary outcome is type 4a MI or major periprocedural myocardial injury defined as high-sensitivity cardiac troponin elevating above 5×99 th percentile upper reference limit in 48 hours after PCI. Patients will continue receiving standard pharmacotherapy or additional biweekly subcutaneous alirocumab 75 mg for 3 months according to the initial randomisation group. We will follow up for 3 months and record all the major adverse cardiovascular events (MACEs). Incidence of PCI-related MI or major periprocedural myocardial injury, and MACE in 3 months after PCI will be compared between control group and alirocumab group.

Ethics and dissemination
Ethics approval has been obtained from the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University with approval number: (2022)02-140-01. The results of this study will be reported through peer-reviewed journals and conference presentations.

Trial registration number
ChiCTR2200063191.

Introduction
Emicizumab prophylaxis substantially reduces bleeding episodes in patients with haemophilia A (HA). The haemostatic efficacy of emicizumab in patients with HA is estimated as approximately 15% based on mimic activity of factor (F) VIII. Although it has been proven effective in preventing bleeding, its haemostatic effect during breakthrough bleeding or surgery is considered insufficient. Therefore, haemostatic management of emicizumab-treated patients with HA without inhibitors frequently requires FVIII replacement therapy. In haemostatic management of emicizumab-treated patients with HA, conventional FVIII dosage calculations are used in clinical practice without considering the coagulant effects of emicizumab.

Methods and analysis
In the CAGUYAMA study, 100 patients with HA without inhibitors will be enrolled for a maximum duration of 1 year, and samples of 30 events following the concomitant use of FVIII concentrates (30±5 U/kg) with emicizumab will be collected. An ‘event’ is defined as obtaining blood samples at preadministration and postadministration of FVIII concentrates during a breakthrough bleeding or a surgical procedure. Global coagulation assays will be used to measure the coagulation potential of the obtained samples. Clot waveform analysis (CWA) is used to identify the primary end-point, that is, the degree of improvement in the maximum coagulation rate at preadministration and post-administration of fixed-dose FVIII concentrations. The parameter obtained from CWA, which is triggered by an optimally diluted mixture of prothrombin time reagent and activated partial thromboplastin time reagent, is reported to be an excellent marker for assessing the degree of improvement of the coagulation potential in emicizumab-treated plasmas.

Ethics and dissemination
The CAGUYAMA study was approved by the Japan-Certified Review Board of Nara Medical University (Approval ID; nara0031). The study results will be communicated through publication in international scientific journals and presentations at (inter)national conferences.

Trial registration number
jRCTs051210137.

Introduction
Individuals with anorexia nervosa (AN) harbour distinct gut microbiomes compared with healthy individuals, which are sufficient to induce weight loss and anxiety-like behaviours when transplanted into germ-free mice. We hypothesise that faecal microbiome transfer (FMT) from healthy donors would help restore the gut microbiome of individuals with AN, which in turn, may aid patient recovery.

Methods
We aim to conduct an open-label pilot study in 20 females aged 16–32 years in Auckland, New Zealand who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for AN and have a body mass index 13–19 kg/m2. We will recruit four healthy, lean, female donors, aged 18–32 years, who will undergo extensive clinical screening prior to stool donation. Faecal microbiota will be harvested from donors and double encapsulated in delayed release, acid-resistant capsules. All participants will receive a single course of 20 FMT capsules (five from each donor) which they can choose to take over two or four consecutive days. Stool and blood samples will be collected from participants over a period of 3 months to assess their gut microbiome profile, metabolome, levels of intestinal inflammation and nutritional status. Our primary outcome is a shift in the gut microbiome composition at 3 weeks post-FMT (Bray-Curtis dissimilarity). We will also monitor participants’ body composition (whole-body dual-energy X-ray absorptiometry scans), eating disorder psychopathology, mental health and assess their views on, and tolerability of, treatment. All adverse events will be recorded and reviewed by an independent data monitoring committee.

Ethics and dissemination
Ethics approval was provided by the Central Health and Disability Ethics Committee (Ministry of Health, New Zealand, 21/CEN/212). Results will be published in peer-reviewed journals and presented to both scientific and consumer group audiences.

Trial registration number
ACTRN12621001504808.

Introduction
Patients with head and neck cancer have a substantial risk of chronic opioid dependence following surgery due to pain and psychosocial consequences from both the disease process and its treatments. Conditioned open-label placebos (COLPs) have been effective for reducing the dose of active medication required for a clinical response across a wide range of medical conditions. We hypothesise that the addition of COLPs to standard multimodal analgesia will be associated with reduced baseline opioid consumption by 5 days after surgery in comparison to standard multimodal analgesia alone in patients with head and neck cancer.

Methods and analysis
This randomised controlled trial will evaluate the use of COLP for adjunctive pain management in patients with head and neck cancer. Participants will be randomised with 1:1 allocation to either the treatment as usual or COLP group. All participants will receive standard multimodal analgesia, including opioids. The COLP group will additionally receive conditioning (ie, exposure to a clove oil scent) paired with active and placebo opioids for 5 days. Participants will complete surveys on pain, opioid consumption and depression symptoms through 6 months after surgery. Average change in baseline opioid consumption by postoperative day 5 and average pain levels and opioid consumption through 6 months will be compared between groups.

Ethics and dissemination
There remains a demand for more effective and safer strategies for postoperative pain management in patients with head and neck cancer as chronic opioid dependence has been associated with decreased survival in this patient population. Results from this study may lay the groundwork for further investigation of COLPs as a strategy for adjunctive pain management in patients with head and neck cancer. This clinical trial has been approved by the Johns Hopkins University Institutional Review Board (IRB00276225) and is registered on the National Institutes of Health Clinical Trials Database.

Trial registration number
NCT04973748.

Introduction
Nurses frequently place a peripheral venous catheter during children’s hospitalisation. Many studies suggest treatment of venipuncture-related pain. The administration of an equimolar mixture of oxygen and nitrous oxide (EMONO) is employed for pain control; however, no studies have analysed the association between EMONO and audiovisuals.
The purpose of the study is to evaluate the effect of EMONO administration when combined with audiovisuals (EMONO+Audiovisual) versus EMONO alone on perceived pain, side effects and level of cooperation during peripheral venous access placement in children aged 2–5 years.

Methods and analysis
The first 120 eligible children admitted to the paediatric ward of the Lodi Hospital and presenting the indication for peripheral venous access will be enrolled. Sixty children will be randomly assigned to the experimental group (EMONO+Audiovisual) and 60 to the control group (EMONO alone).
The Face, Legs, Activity, Cry, Consolability scale will be used to assess pain in the children aged 2-years old; pain in the children aged 3–5 years will be assessed using the Wong-Baker scale. The cooperation throughout the procedure will be measured using the Groningen Distress Rating Scale.

Ethics and dissemination
The Milan Area 1 Ethics Committee approved the study protocol (Experiment Registry No. 2020/ST/295). The trial results will be presented at conferences and published in peer-reviewed journals.

Trial registration number
NCT05435118.

Objective
The study contextualises the spatial heterogeneity and associated drivers of open defecation (OD) in India.

Design
The present study involved a secondary cross-sectional survey data from the fifth round of the National Family Health Survey conducted during 2019–2021 in India. We mapped the spatial heterogeneity of OD practices using LISA clustering techniques and assessed the critical drivers of OD using multivariate regression models. Fairlie decomposition model was used to identify the factors responsible for developing OD hot spots and cold spots.

Setting and participants
The study was conducted in India and included 636 699 sampled households within 36 states and union territories covering 707 districts of India.

Primary and secondary outcome measures
The outcome measure was the prevalence of OD.

Results
The prevalence of OD was almost 20%, with hot spots primarily located in the north-central belts of the country. The rural–urban (26% vs 6%), illiterate-higher educated (32% vs 4%) and poor-rich (52% vs 2%) gaps in OD were very high. The odds of OD were 2.7 and 1.9 times higher in rural areas and households without water supply service on premises compared with their counterparts. The spatial error model identified households with an illiterate head (coefficient=0.50, p=0.001) as the leading spatially linked predictor of OD, followed by the poorest (coefficient=0.31, p=0.001) and the Hindu (coefficient=0.10, p=0.001). The high-high and low-low cluster inequality in OD was 38%, with household wealth quintile (67%) found to be the most significant contributing factor, followed by religion (22.8%) and level of education (6%).

Conclusion
The practice of OD is concentrated in the north-central belt of India and is particularly among the poor, illiterate and socially backward groups. Policy measures should be taken to improve sanitation practices, particularly in high-focus districts and among vulnerable groups, by adopting multispectral and multisectoral approaches.

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.

In February 2023, North Dakota advanced legislation to remove transgender identity from state data collection. “Prostate cancer ought not show up in female reporting,” testified Representative SuAnn Olson, who cosponsored the bill.