Risultati per: Cardio-oncology: rivista open access

Circulation, Volume 146, Issue Suppl_1, Page A15314-A15314, November 8, 2022. Introduction:Mycobacterium chimaera is an emerging pathogen, recognized to cause prosthetic valve infective endocarditis (PVIE) and disseminated infection following open-chest cardiac surgery with certain contaminated heater-cooler systems. Diagnosis is challenging and requires a very high index of suspicion. Data regarding the optimal cardiac imaging evaluation of this condition is limited.Methods:Scopus, PubMed, EMBASE, Ovid and Cochrane were searched for published articles through October 2021, using keywords “Mycobacterium chimaera”, “Prosthetic valve” and “Endocarditis”. 169 articles were found and reviewed for study eligibility. Articles were included if they consisted of Mycobacterium chimaera causing IE, with imaging modalities used to establish diagnosisResults:Thirty-three articles were included, yielding twenty-two cases of Mycobacterium chimaera PVIE. The disease manifested on average thirty months after surgery, with an average patient age of 59 years (90% male). Imaging modalities to establish the diagnosis of prosthetic valve infective endocarditis included: transthoracic echocardiogram in 5 cases, transesophageal echocardiogram (TEE) in nine cases, 18F-FDG-PET/CT in seven cases. A combination of imaging modalities with TEE and 18F-FDG-PET/CT was reported once; TTE, TEE and 18F-FDG-PET/CT was also noted in one case. Lastly there was one instance each of combined use of TTE, TEE, and one of the following: CTA, Cardiac MRI, or standard CT. Nine cases did not specify the imaging modality used to achieve diagnosis. Ten patients died.Conclusions:PVIE due to Mycobacterium chimaera infection is a rare and challenging diagnosis, which requires a high index of suspicion. Accurate diagnosis should be aided by multimodality cardiac imaging, with 18F-FDG-PET/CT being a powerful adjunct imaging modality.

Introduction
Sub-Saharan Africa (SSA) region harbours the highest burden of HIV infections in the world. Agricultural work has been reported as one of the occupations with a high prevalence of HIV. Farm workers generally have poor access to health services, which prevents them from receiving proper HIV prevention and care. Furthermore, poor policies and policy implementation, and lack of workplace programmes increases farm workers’ vulnerability to HIV infection. Thus, the aim of this study is to conduct a systematic review to assess HIV prevention and treatment services and national policies governing access to healthcare services by farm workers in SSA.

Methods and analysis
Our systematic review will include studies published from January 1990 to December 2021 within SSA countries. We will use a sensitive search strategy for electronic bibliographic databases and grey literature sources. Databases will include PubMed, CINAHL, Cochrane library, African Index Medicus and Scopus. The main outcomes to be reported will be HIV policy for farmworkers, availability of HIV prevention service(s), availability of treatment and support to farmworkers who are living with HIV, presence of referral structures for farmworkers through the health system and follow-up services for farmworkers who are on antiretroviral therapy. We will synthesise the main characteristics of included studies and use summary measures to describe study characteristics. In a situation where data are not sufficiently homogeneous to perform a quantitative synthesis, we will conduct a narrative synthesis. We will explore themes and relationships between included studies for qualitative data.

Ethics and dissemination
The study will use publicly available data and ethics exemption has been obtained from Human Research Ethics Committees, Faculty of Medicine & Health Sciences, Stellenbosch University. The results of this study will be disseminated through peer-reviewed journals, conference presentations and seminars.

PROSPERO registration number
CRD42021277528.

Introduction
Multiple myeloma is a malignancy of plasma cells with around 6000 new cases per year in the UK. Cyclophosphamide plus prednisolone is considered a standard of care for disease and symptom control in the advanced relapsed or refractory myeloma setting within the UK NHS. The selective nuclear export inhibitor, selinexor, has been relatively well tolerated in previous clinical trials and offers promise when used in combination with a wide range of other anti-cancer treatments. Here, we investigate if the addition of selinexor can improve responses to cyclophosphamide plus prednisolone without adding prohibitive toxicity.

Methods and analysis
MUKtwelve is a UK-based, randomised, controlled, open, parallel group, multicentre phase II trial designed to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisolone (SCP) in patients with relapsed or refractory multiple myeloma. A calibration arm will receive cyclophosphamide and prednisolone alone (CP). Participants who experience disease progression on the CP arm may, if eligible, receive SCP.
The MUKtwelve trial results will be the first to assess clinical efficacy of selinexor with low-dose CP in relapsed/refractory multiple myeloma. It is widely accepted that the relapsing-remitting nature of the disease is accompanied by cellular changes that often result in the requirement for novel agents and drug combinations to regain disease control. Patients also often experience cumulative toxicities throughout their treatments, limiting the treatment intensity that can be given at relapse. Thus, there is a need for novel effective combination therapies with acceptable toxicity profiles.

Ethics and dissemination
Ethics approval is obtained. Results will be submitted for publication in a peer-reviewed journal.

Trial registration number
ISRCTN15028850.

Introduction
Rituximab (RTX) effectively prevents relapses in patients with complicated steroid-sensitive nephrotic syndrome (SSNS). The 1-year relapse-free survival rate is approximately 30% in children after the first episode of SSNS treated with standardised corticosteroids. Whether the benefits of RTX extend to the first relapse are unknown. The efficacy and safety of RTX in the first episode of paediatric idiopathic nephrotic syndrome (RTXFIRPedINS) trial (NCT04783675) will assess its effect on the risk of subsequent relapse.

Methods and analysis
RTXFIRPedINS is an open-label, single-arm, multicentre trial targeting patients aged 1–18 years with a first episode of SSNS. All patients will receive standardised corticosteroid treatment for 12 weeks. A sample size of 44 patients provides 80% power to detect a 20% increase in the 1-year relapse-free rate, assuming a dropout rate of 10%. After obtaining informed consent and screening, eligible patients will be treated with a single intravenous infusion of 375 mg/m2 RTX within 1 week after achieving remission. Trimethoprim-sulfamethoxazole will be administered for 3 months after RTX administration to prevent Pneumocystis carinii infection. The follow-up period will be 1 year. The primary outcome is the 1-year relapse-free survival rate after RTX infusion. The secondary study outcomes are the number of days from the infusion of RTX to the occurrence of the first relapse, 6-month relapse-free survival rate, the B cell recovery time and treatment-related adverse events. Immunological factors will be studied as predictors of response.

Ethics and dissemination
This trial was approved by the Ethics Committee of the Children’s Hospital of Fudan University and seven local ethics committees. We will publish our study results in peer-reviewed journals and present them at international scientific meetings.

Trial registration number
NCT04783675

Automated insulin delivery (AID) systems—also known as closed-loop or artificial pancreas systems—for type 1 diabetes are growing in popularity. In a recent study, an unregulated open-source AID system was more effective for blood glucose control in type 1 diabetes than a conventional sensor–augmented insulin pump.

Objectives
Multiple social-cultural and contextual factors influence access to and acceptance of cancer treatment in Ghana. The aim of this research was to assess existing literature on how these factors interplay and could be susceptible to local and national policy changes.

Design
This study uses a critical interpretive synthesis approach to review qualitative and quantitative evidence about access to adult cancer treatment services in Ghana, applying the socioecological model and candidacy framework.

Results
Our findings highlighted barriers to accessing cancer services within each level of the socioecological model (intrapersonal, interpersonal community, organisational and policy levels), which are dynamic and interacting, for example, community level factors influenced individual perceptions and how they managed financial barriers. Evidence was lacking in relation to determinants of treatment non-acceptance across all cancers and in the most vulnerable societal groups due to methodological limitations.

Conclusions
Future policy should prioritise multilevel approaches, for example, improving the quality and affordability of medical care while also providing collaboration with traditional and complementary care systems to refer patients. Research should seek to overcome methodological limitations to understand the determinants of accessing treatment in the most vulnerable populations.

In the Brief Report titled, “Differences in Thickness-Specific Incidence and Factors Associated With Cutaneous Melanoma in the US From 2010 to 2018,” which published online March 24, 2022, and in print in the May 2022 issue, the article status was changed to open access (CC-BY license). This article was updated online.

This decision analytical model study examines premature treatment discontinuation in clinical trials for patients with advanced renal cell carcinoma.

The Original Investigation titled “Receipt of Telehealth Services, Receipt and Retention of Medications for Opioid Use Disorder, and Medically Treated Overdose Among Medicare Beneficiaries Before and During the COVID-19 Pandemic,” published online August 31, 2022, was changed to open access status under the CC-BY license. This article was corrected online.

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
Previous studies have demonstrated that one anastomosis gastric bypass (OAGB) is not inferior to Roux-en-Y gastric bypass (RYGB) in treating obesity. However, high level evidence comparing the efficacy and safety of both procedures in type 2 diabetes (T2D) treatment is still lacking, which is another main aim of bariatric surgery. The presented trial has been designed to aim at investigating the superiority of OAGB over the reference procedure RYGB in treating T2D as primary endpoint. And diabetes-related microvascular and macrovascular complications, cardiovascular comorbidities, weight loss, postoperative nutritional status, quality of life and overall complications will be followed up for 5 years as secondary endpoints.

Methods and analysis
This prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI≥27.5 kg/m2) who are diagnosed with T2D will be randomly assigned (1:1) to OAGB or RYGB with blocks of four. The primary endpoint is the complete diabetes remission rate defined as HbA1c≤6.0% and fasting plasma glucose≤5.6 mmol/L without any antidiabetic medications at 1 year after surgery. All secondary endpoints will be measured at different follow-up visit points, which will start at least 3 months after enrolment, with a continuous annual follow-up for five postoperative years in order to provide solid evidence on the efficacy and safety of OAGB in patients with T2D.

Ethics and dissemination
The study has been approved by the ethics committee of leading centre (Beijing Friendship Hospital, Capital Medical University, no. 2021-P2-037-03). The results generated from this work will be disseminated to academic audiences and the public via publications in international peer-reviewed journals and conferences. The data presented will be imported into a national data registry. Findings are expected to be available in 2025, which will facilitate clinical decision-making in the field.

Trial registration number
NCT05015283.

Introduction
For over 40 years, Aboriginal and Torres Strait Islander Community-Controlled Health Services (ACCHS) in Australia have led strategic responses to address the specific needs of Aboriginal and Torres Strait Islander populations. Globally, there has been rapid growth in urban Indigenous populations requiring an adaptive primary healthcare response. Patient-centred medical homes (PCMH) are an evidenced-based model of primary healthcare suited to this challenge, underpinned by principles aligned with the ACCHS sector—relational care responsive to patient identified healthcare priorities. Evidence is lacking on the implementation and effectiveness of the PCMH model of care governed by, and delivered for, Aboriginal and Torres Strait Islander populations in large urban settings.

Method and analysis
Our multiphased mixed-methods prospective cohort study will compare standard care provided by a network of ACCHS to an adapted PCMH model of care. Phase 1 using qualitative interviews with staff and patients and quantitative analysis of routine primary care health record data will examine the implementation, feasibility and acceptability of the PCMH. Phase 2 using linked survey, primary care and hospitalisation data will examine the impact of our adapted PCMH on access to care, relational and quality of care, health and wellbeing outcomes and economic costs. Phase 3 will synthesise evidence on mechanisms for change and discuss their implications for sustainability and transferability of PCMHs to the broader primary healthcare system

Ethics and dissemination
This study has received approval from the University of Queensland Human Research Ethics Committee (2021/HE00529). This research represents an Aboriginal led and governed partnership in response to identified community priorities. The findings will contribute new knowledge on how key mechanisms underpinning the success and implementation of the model can be introduced into policy and practice. Study findings will be disseminated to service providers, researchers, policymakers and, most importantly, the communities themselves.

Background
The HIV epidemic in key populations such as men who have sex with men (MSM) is a public health issue of worldwide concern. China has seen an increase in newly diagnosed HIV infections through male–male sexual contact in the past decade. In a long-term cohort, how the complex behaviour pattern of MSM changed and the association with the HIV risk are unclear at present.

Methods
This study was conducted from October 2011 to December 2019 in Tianjin. MSM were recruited by snowball sampling through online and offline ways. Demographic and sexual behavioural data were collected for analysis. Three indicators (condom use in last anal sex, frequency of condom use during anal sex and the number of sexual partners) were used to define the behaviour change. Participants with zero, one, and two or three risk indicators were categorised into behaviour types of ‘protective’, ‘moderate’, and ‘fragile’, respectively. Change in behaviour type between baseline and each visit was considered. Time-varying Cox models were performed to evaluate HIV infection risk.

Results
Of 2029 MSM included in the study, 127 were new HIV diagnoses. The overall incidence rate was 3.36 per 100 person-years. The percentage of ‘protective’ and ‘moderate’ behaviour types had a conspicuous growth trend as the follow-up. Furthermore, the HIV incidence rate in each visit among different behaviour transition types showed a general downward trend as the number of total follow-up times increased. Individuals who remained in ‘fragile’ (adjusted HR (aHR): 25.86, 95% CI: 6.92 to 96.57) or changed from ‘protective’ to ‘moderate’ (aHR: 4.79, 95% CI: 1.18 to 19.47), ‘protective’ to ‘fragile’ (aHR: 23.03, 95% CI: 6.02 to 88.13), and ‘moderate’ to ‘fragile’ (aHR: 25.48, 95% CI: 6.79 to 95.40) between baseline and the last follow-up had a higher HIV risk. Gained risk indicators were associated with the increase of HIV risk (gained one indicator, aHR: 2.67, 95% CI: 1.68 to 4.24; gained two or three indicators, aHR: 4.99, 95% CI: 3.00 to 8.31) while losing just one risk indicator could halve the risk (aHR: 0.43, 95% CI: 0.21 to 0.90).

Conclusions
Among MSM in Tianjin, it is necessary to get timely behaviour change for those with high-incidence behaviour patterns while sustaining for those with low-incidence patterns.

Trial registration number
Chinese Clinical Trials Registry (ChiCTR2000039500).

Introduction
Hip fractures treated with total hip arthroplasty (THA) are at high risk of prosthesis instability, and dislocation is the most common indication for revision surgery. This study aims to determine whether dual mobility THA implants reduce the risk of dislocation compared with conventional THA in patients with hip fracture suitable to be treated with THA.

Methods and analysis
This is a cluster-randomised, crossover, open-label trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will comprise hospitals that perform at least 12 THAs for hip fracture per annum. All adults age ≥50 years who meet the Australian and New Zealand Hip Fracture Registry guidelines for THA will be included. The intervention will be dual mobility THA and the comparator will be conventional THA. Each hospital will be allocated to two consecutive periods, one of dual mobility THA and the other of conventional THA in random order, aiming for an average of 16 patients eligible for the primary analysis per group (32 total per site), allowing different recruitment totals between sites. Data will be collected through the AOANJRR and linked with patient-level discharge data acquired through government agencies. The primary outcome is dislocation within 1 year. Secondary outcomes include revision surgery for dislocation and all-cause, complications and mortality at 1, 2 and 5 years. If dual mobility THA is found to be superior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 1536 patients from at least 48 hospitals over 3 years.

Ethics and dissemination
Ethics approval has been granted (Sydney Local Health District – Royal Prince Alfred Hospital Zone (approval X20-0162 and 2020/ETH00680) and site-specific approvals). Participant recruitment is via an opt-out consent process as both treatments are considered accepted, standard practice. The trial is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.

Trial registration number
ACTRN12621000069853.

Introduction
Hypoaccommodation is common in children born prematurely and those with hypoxic ischaemic encephalopathy (HIE), with the potential to affect wider learning. These children are also at risk of longer-term cerebral visual impairment. It is also well recognised that early intervention for childhood visual pathology is essential, because neuroplasticity progressively diminishes during early life. This study aims to establish the feasibility and acceptability of conducting a randomised controlled trial to test the effectiveness of early near vision correction with spectacles in infancy, for babies, at risk of visual dysfunction.

Methods and analysis
This is a parallel group, open-label, randomised controlled (feasibility) study to assess visual outcomes in children with perinatal brain injury when prescribed near vision spectacles compared with the current standard care—waiting until a problem is detected. The study hypothesis is that accommodation, and possibly other aspects of vision, may be improved by intervening earlier with near vision glasses. Eligible infants (n=75, with either HIE or