Risultati per: Cardio-oncology: rivista open access

Circulation, Ahead of Print. Advances in cancer therapeutics have revolutionized survival outcomes in patients with cancer. However, cardiovascular toxicities associated with specific cancer therapeutics adversely affect the outcomes of patients with cancer. Recent studies have uncovered excess risks of these cardiotoxic events, especially in traditionally underrepresented populations. Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations. Previously decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigation, and potential optimal strategies to address disparate cardiotoxicity in contemporary cancer care (eg, with immunotherapy, biologic, or cytotoxic therapies) settings. This scientific statement aims to define the current state of evidence for disparate cardiotoxicity while proposing uniform and novel methodological approaches to inform the identification and mitigation of disparate cardio-oncology outcomes in future clinical trials, registries, and daily clinical care settings. We also propose an evidence-based integrated approach to identify and mitigate disparities in the routine clinical setting. This consensus scientific statement summarizes and clarifies available evidence while providing guidance on addressing inequities in the era of emerging anticancer therapies.

Introduction
Emicizumab effectively prevents bleeding in people with haemophilia A (PwHA), but is a burden for national healthcare budgets and consequently may limit access. According to the drug label, dosing of emicizumab is based on body weight with fixed intervals of 7, 14 or 28 days, which leads to mean plasma concentrations of 55 µg/mL (SD 15 µg/mL). However, a moderate variability of concentrations and a minimal effective concentration of 30 µg/mL have been suggested in studies. Therefore, a dose of emicizumab that targets a trough concentration of 30 µg/mL is hypothesised to be equally effective as conventional dosing in the prevention of bleeding.

Methods and analysis
We designed a phase IV, multicentre, open-label, crossover study to evaluate non-inferiority of bleed control of ≥6 months on conventional dosing in comparison to ≥6 months on dose intervention. This dose intervention consists of reducing the dose of emicizumab to target a trough concentrations of 30 µg/mL using individual pharmacokinetic (PK) parameters. Ninety-five PwHA aged >1 years who received conventional dosing of emicizumab for ≥12 months with good bleeding control during the last 6 months will be recruited from all Dutch haemophilia treatment centres. The study is powered to detect a clinically relevant decrease (risk difference) of 15% in the proportion of patients without treated bleeds during follow-up. Secondary endpoints are spontaneous joint or muscle bleeds, and annualised treated bleeding rates (using negative binomial regression). Cost-effectivity between conventional dosing and individualised PK-guided dosing of emicizumab will be compared.

Ethics and dissemination
The DosEmi study was approved by the Medical Ethics Review Committee NedMec of the University Medical Center of Utrecht, The Netherlands. Study results will be communicated through publications in international scientific journals and presentations at (inter)national conferences.

Trial registration number
EUCTR2021-004039-10-NL at https://trialsearch.who.int.

Protocol version
V.4.1 on 28 October 2022 (DosEmi protocol_V4.1; NL81112.041.22).

Objectives
There are few reports on regional differences in the supply/utilisation balance and provision of rehabilitation services. This study analysed those regional differences in Japan to help policymakers provide more uniform and efficient rehabilitation services and optimally allocate related resources.

Design
An ecological study.

Setting
47 prefectures and 9 regions in Japan in 2017.

Primary and secondary outcome measures
Primary measures were ‘supply/utilisation (S/U) ratio’, calculated by dividing rehabilitation supply converted to service units, by rehabilitation utilisation and ‘utilisation/expected utilisation (U/EU) ratio’, calculated by dividing utilisation by EU. The EU was defined as utilisation expected from the demography in each area. Data required to calculate these indicators were collected from open sources such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data Japan.

Results
The S/U ratios were higher in Shikoku, Kyusyu, Tohoku and Hokuriku regions, and lower in Kanto and Tokai regions. The number of rehabilitation providers per population was higher mostly in the western part of Japan and lower mostly in the eastern part. The U/EU ratios were also higher mostly in the western part, and lower mostly in the eastern part such as Tohoku and Hokuriku regions. The same trend was seen for cerebrovascular disease and musculoskeletal disorder rehabilitation, which accounted for approximately 84% of rehabilitation services. For disuse syndrome rehabilitation, such a trend did not exist, and the U/EU ratio differed by prefectures.

Conclusions
The large surplus in rehabilitation supply in the western part was attributed to the greater number of providers, while the smaller surplus in Kanto and Tokai regions was due to the smaller amount of supply. The number of rehabilitation services used was lesser in the eastern part such as Tohoku and Hokuriku regions, indicating regional differences in the provision of rehabilitation services.

New recommendations from the US Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) could simplify the ability of schools to provide health care, particularly mental health services, to students.

Objectives
The medical reform in 2009 stimulated the growth of private healthcare organisations in China, but there is still room for their further development in the healthcare market. The objectives of the study were to provide more information about the healthcare market in China and to explore the challenges private healthcare organisations faced.

Design
Qualitative descriptive study using a web-based open-ended questionnaire and thematic content analysis. Data were collected between 12 February and 20 February 2020.

Setting
This study was conducted in China.

Participants
124 respondents from private healthcare organisations across 20 provinces in China.

Results
Our content analysis identified three themes: (1) functioning and positioning of the healthcare institutions: current private healthcare organisations generally serve as a supplement to public hospitals and focus more on specialised medical and high-end services; (2) institutions’ advantages: private healthcare organisations can flexibly respond to market demands, formulate effective strategies, introduce advanced management concepts and methods, provide personalised and diversified services, and introduce new technologies which can stimulate market vitality and promote healthy competition; and (3) institutions’ challenges: private healthcare organisations face difficulties in professional development and talent cultivation, branding and establishing a reputation, and the policies for institution establishment, tax and medical insurance pose drawbacks to their development.

Conclusion
This study illustrates that private healthcare organisations need more government support for further development, such as providing a fairer insurance strategy and taxation policy, affording ground for a more equitable scientific research environment and promotion opportunities, and evaluating reputation score for healthcare institutions.

Introduction
Cerebrovascular intervention is an excellent option to treat cerebrovascular diseases. Interventional access is a prerequisite and a foundation for cerebrovascular intervention, which is crucial to the success of an intervention. Although transfemoral arterial access (TFA) has become a popular and acceptable method of access for cerebrovascular angiography and intervention in clinical practice, it has some drawbacks that limit the usage in cerebrovascular interventions. Therefore, transcarotid arterial access (TCA) has been developed in cerebrovascular interventions. We aim to conduct a systematic review to compare the safety and efficacy of TCA with TFA for cerebrovascular intervention.

Methods and analysis
In this protocol, Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols were followed. PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials will be searched mainly from 1 January 2004, to the formal search date. Additionally, reference lists and clinical trial registries will be searched. We will include clinical trials with more than 30 participants, which reported the endpoints of stroke, death and myocardial infarction. Two investigators will independently select studies, extract data and assess bias risk. A standardised mean difference with 95% CI will be presented for continuous data, and a risk ratio with 95% CI will be presented for dichotomous data. On inclusion of sufficient studies, subgroup analysis and sensitivity analysis will be conducted. The funnel plot and Egger’s test will be used to assess publication bias.

Ethics and dissemination
As only published sources will be used in this review, ethical approval is not required. We will publish the results in a peer-reviewed journal.

PROSPERO registration number
CRD42022316468.

Introduction
African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population.

Methods and analysis
The goal of the current study is to systematically adapt a patient–provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women’s reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA.

Ethics and dissemination
This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations.

Trial registration number
NCT04373551.

Objective
We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) pathway, and to add to the current knowledge base of drug approval processes.

Design, setting, participants
This cross-sectional study thoroughly examines novel oncology drugs with dual approval through FDA AA and EMA CMA between 2006 and 2021. Statistical analysis was performed from June to July 2022.

Primary and secondary outcome measures
The study examined the regulatory differences between regions for dually approved novel oncology drugs, including approval decisions, pivotal efficacy clinical trials, speed of review and postmarketing obligations.

Results
During this time period, there was a difference in the use of the FDA AA and the EMA CMA (FDA: EMA: 41.2%: 70.0%, p

Introduction
Current guidelines recommend moderate-intensity lipid lowering (low-density lipoprotein cholesterol, LDL-C of

Introduction
Long COVID is a prevalent condition with many multisystemic symptoms, such as fatigue, dyspnoea, muscle weakness, anxiety, depression and sleep difficulties, impacting daily life and (social and physical) functioning. Pulmonary rehabilitation (PR) may improve physical status and symptoms of patients with long COVID, yet the evidence is limited. Therefore, this trial aims to study the effect of primary care PR on exercise capacity, symptoms, physical activity and sleep in patients with long COVID.

Methods and analysis
PuRe-COVID is a prospective, pragmatic, open-label, randomised controlled trial. A sample of 134 adult patients with long COVID will be randomised to a 12 week PR programme in primary care, supervised by a physiotherapist or to a control group, following no PR. A 3 month and 6 month follow-up period is foreseen. The primary endpoint will be the change in exercise capacity measured by 6-minute walk distance (6MWD) at 12 weeks, hypothesising a more significant improvement in the PR group. Other parameters, such as pulmonary function tests (including maximal inspiratory pressure/maximal expiratory pressure), patient-reported outcomes (COPD Assessment Test, modified Medical Research Council Dyspnoea Scale, Checklist Individual Strength, post-COVID-19 Functional Status, Nijmegen questionnaire, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment Questionnaire and EuroQol-5D-5L), physical activity measured by an activity tracker, hand grip strength and sleep efficiency, are secondary and exploratory outcomes.
The recruitment started on 19 April 2022, and 52 patients were included as of 14 December 2022.

Ethics and dissemination
Ethical approval was obtained in Belgium from the relevant institutional review boards on 21 February 2022 (Antwerp University Hospital, approval number 2022-3067) and on 1 April 2022 (Ziekenhuis Oost-Limburg in Genk, approval number Z-2022-01). Findings from this randomised controlled trial will be disseminated in peer-reviewed publications and presentations at international scientific meetings.

Trial registration number
NCT05244044.

Introduction
Children with bone and joint infections are traditionally treated with intravenous antibiotics for 3–10 days, followed by oral antibiotics. Oral-only treatment has not been tested in randomised trials.

Methods and analysis
Children (3 months to 18 years) will be randomised 1:1 with the experimental group receiving high-dose oral antibiotics and the control group receiving intravenous antibiotics with a shift in both groups to standard oral antibiotics after clinical and paraclinical improvement. Children in need of acute surgery or systemic features requiring intravenous therapy, including septic shock, are excluded. The primary outcome is defined as a normal blinded standardised clinical assessment 6 months after end of treatment. Secondary outcomes are non-acute treatment failure and recurrent infection. Outcomes will be compared by a non-inferiority assumption with an inferiority margin of 5%.

Ethics and dissemination
The trial has the potential to reduce unnecessary hospitalisation and use of intravenous antibiotics in children with bone or joint infections. Due to the close follow-up, exclusion of severely ill children and predefined criteria for discontinuation of the allocated therapy, we expect the risk of treatment failure to be minimal.

Trial registration number
NCT04563325.

Objectives
The aim of this study was to obtain an in-depth perspective from stakeholders involved in access to kidney transplantation to pave the way for solutions in improving access to kidney transplantation. This study qualitatively explored factors influencing optimal access to kidney transplantation from a broad stakeholder perspective.

Design
A qualitative study was performed using semistructured interviews both in focus groups and with individual participants. All interviews were recorded, transcribed and coded according to the principles of grounded theory.

Setting
Participants were healthcare providers (geographically spread), patients and (former living) kidney donors, policy-makers and insurers.

Participants
Stakeholders (N=87) were interviewed regarding their perceptions, opinions and attitudes regarding access to kidney transplantation.

Results
The problems identified by stakeholders within the domains—policy, medical, psychological, social and economic—were acknowledged by all respondents. According to respondents, more efforts should be made to make healthcare providers and patients aware of the clinical guideline for kidney transplantation. The same opinion applied to differences in medical inclusion criteria used in the different transplantation centres. Stakeholders saw room for improvement based on psychological and social themes, especially regarding the provision of information. Many stakeholders described the need to rethink the current economic model to improve access to kidney transplantation. This discussion led to a definition of the most urgent problems for which, according to the respondents, a solution must be sought to optimise access to kidney transplantation.

Conclusions
Stakeholders indicated a high sense of urgency to solve barriers in patient access to kidney transplantation. Moreover, it appears that some barriers are quite straightforward to overcome; according to stakeholders, it is striking that this process has not yet been overcome. Stakeholders involved in kidney transplantation have provided directions for future solutions, and now it is possible to search for solutions with them.

Objective
To examine the association between household access to water, sanitation and handwashing (WaSH) facilities and child undernutrition in Bangladesh.

Design, setting and participants
Cross-sectional study of children less than 5 years using data collected from the 2019 Multiple Indicator Cluster Survey (MICS) and the 2017–2018 Bangladesh Demographic and Health Survey (BDHS).

Outcome measures
Stunting, wasting and underweight, defined as a Z-score

This cross-sectional study examines private equity–backed acquisitions of medical and radiation oncology clinics in the US from 2003 to 2022 using financial databases and publicly available data.

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.

Introduction
Deep brain stimulation (DBS) implantation under general anaesthesia (GA) has been applied to patients with Parkinson’s disease (PD) with severe comorbidities or disabling off-medication symptoms. However, general anaesthetics may affect intraoperative microelectrode recording (MER) to varying degrees. At present, there are few studies on the effects of sedatives or general anaesthetics on multiunit activity characteristics performed by MER in patients with PD during DBS. Therefore, the effect of the choice of anaesthesia on MER remains unclear.

Methods/design
This is a prospective randomised controlled, non-inferiority study that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients undergoing elective bilateral subthalamic nucleus (STN)-DBS will be enrolled after careful screening for eligibility. One hundred and eighty-eight patients will be randomised to receive either conscious sedation (CS) or GA at a 1:1 ratio. The primary outcome is the proportion of high normalised root mean square (NRMS) recorded by the MER signal.

Ethics and dissemination
The study was approved by the Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2022-147-02). Negative study results will indicate that GA using desflurane has a non-inferior effect on MER during STN-DBS compared with CS. The results of this clinical trial will be presented at national or international conferences and submitted to a peer-reviewed journal.

Trial registration number
NCT05550714.