Risultati per: Cardio-oncology: rivista open access

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

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 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.

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.

Introduction
The rapid evolution of the therapeutic landscape in oncology poses challenges to optimal treatment sequencing. Evidence for clinical decision-making is often limited to studies focused on treatment evaluation at a single decision point, with limited capability of identifying delayed effects of prior treatment decisions on the efficacy and feasibility of future treatments. There is a growing interest in dynamic treatment regimes (DTRs) evaluation as it provides guidance on treatment individualisation based on evolving treatment and patient characteristics. In this scoping review we aim to systematically map how and to what extent DTRs have been evaluated in clinical studies to generate evidence for clinical decision-making in oncology.

Methods and analysis
We will do a systematic literature search in MEDLINE (PubMed), Web of Science, Scopus and WHO international clinical trials registry platform to identify clinical studies (including protocols of ongoing studies), with either experimental or observational design, that aim to answer a clinical question and explore treatment sequencing issues in oncology using the concept of DTR. Data extraction will comprise information concerning cancer disease, clinical setting, treatments, tailoring variables, decision rules, decision points and outcomes, type of data, study design and statistical methods used for DTR evaluation. The review will be conducted according to Joanna Briggs Institute Reviewer’s manual for scoping reviews. No patients will be involved.

Ethics and dissemination
Ethics committee approval is not required as this scoping review will undertake secondary analysis of published literature. Results will be disseminated through a peer-reviewed scientific journal and presented in relevant conferences. This scoping review will provide a better understanding of the methods used to generate evidence on treatment sequencing in oncology and will contribute to the identification of knowledge and methodological gaps that should be addressed.

Objectives
Previous research highlighted that in the early 2000s a significant share of the Italian population used and paid out of pocket for private healthcare services even when they could potentially have received the same treatments from the National Health Service (NHS). The decrease in public investments in healthcare and the increase in health needs due to the population ageing may have modified the use of private health services and equity of access to the Italian NHS. This study aims to investigate the change in the prevalence of individuals who have fully paid out of pocket for accessing healthcare services in Italy between 2006 and 2019 and the main reasons behind this choice.

Design
Cross-sectional comparative study.

Participants and comparison
Two representative samples of the Italian population were collected in 2006 and 2019.

Outcome measures
Prevalence of access to fully paid out-of-pocket private health services; type of service of the last fully paid out-of-pocket access; main reasons for the last fully paid out-of-pocket access.

Results
We found an increase in the prevalence of people who declared having fully paid out of pocket at least one access to health services during their lifetime from 79.0% in 2006 to 91.9% in 2019 (adjusted OR 2.66; 95% CI 1.98 to 3.58). ‘To avoid waiting times’ was the main reason and it was significantly more frequent in 2019 compared with 2006 (adjusted OR 1.75; 95% CI 1.45 to 2.11).

Conclusions
This comparative study, conducted the year before the outbreak of the COVID-19 pandemic, highlighted an increase in the prevalence of Italian residents who have fully paid out of pocket for access to health services to overcome long waiting times. Our findings may indicate a reduced access and possible worsening of the equity of access to the public and universalistic Italian NHS between 2006 and 2019.

Objectives
As understanding of the pathogenesis and treatment strategies for osteoarthritis (OA) evolves, it is important to understand how patient factors are also changing. Our goal was to examine demographics and known risk factors of patients with OA over time.

Design
Open-cohort retrospective study using electronic health records.

Setting
Large US integrated health system with 7 hospitals, 2.6 million outpatient clinic visits and 97 300 hospital admissions annually in a mostly rural geographic region.

Participants
Adult patients with at least two encounters and a diagnosis of OA or OA-relevant surgery between 2001 and 2018. Because of geographic region, over 96% of participants were white/Caucasian.

Interventions
None.

Primary and secondary outcome measures
Descriptive statistics were used to examine age, sex, body mass index (BMI), Charlson Comorbidity Index, major comorbidities and OA-relevant prescribing over time.

Results
We identified 290 897 patients with OA. Prevalence of OA increased significantly from 6.7% to 33.5% and incidence increased 37% (from 3772 to 5142 new cases per 100 000 patients per year) (p

Introduction
Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy.

Methods and analysis
This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1–4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events.

Ethics and dissemination
The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications.

Trial registration number
NCT04985695.