Risultati per: Cardio-oncology: rivista open access

If the recently leaked ruling from the US Supreme Court in Dobbs v. Jackson Women’s Health Organization is any indication of the future of abortion care in the US, Roe v. Wade will soon no longer be the law of the land, and access to care will be determined by state laws. It is estimated that about half of states will ban abortion, putting an essential, time-sensitive component of comprehensive health care out of reach.

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.

Objective
Equitable and affordable access to improved sanitation facilities is linked to health and is among the priority areas of development programmes in a country like India. This study assesses the level of different sanitation facilities accessed by households and attempts to understand the socioeconomic characteristics of the households that received financial benefits from the Swachh Bharat Mission (Swachh Bharat Abhiyan), a Government of India flagship programme.

Design
Cross-sectional study.

Setting and participants
The study extracted data from the 76th round (2018) of the National Sample Survey, consisting of 106 837 households in India.

Outcome measures
Sanitation services and benefits received from the Swachh Bharat Mission in the last 3 years preceding the survey were the two outcome variables of this study. Bivariate and multinomial logistic regression analysis were performed to identify factors associated with the outcome variables.

Results
Findings show the existence of state and regional disparities, along with rural–urban gaps, in the accessibility of sanitation facilities. Half of the households (52%, n=55 555) had access to safely managed sanitation facilities, followed by basic services (14.8%, n=15 812), limited services (11.4%, n=12 179) and unimproved services/open defecation (21.8%, n=23 290). Limited and unimproved facilities decreased significantly (p

Introduction
Nurses comprise the largest group of health workers globally and are essential to the provision of care necessary for delivering curative therapy to children with cancer. In high-income countries, previous studies of the nurse workforce have shown an association between patient morbidity and mortality and nursing-related factors such as staffing, education and the nursing practice environment. There is currently limited evidence available to define the scope of essential core competencies for paediatric oncology nursing (PON) practice internationally and specifically in Latin America. Clearly defined essential core competencies contribute to establishing nurses’ scope of practice within clinical practice, education and research settings. Here, we aimed to map and synthesise the available evidence on the scope of PON practices in the context of clinical practice, educational training and research settings in Latin America.

Methods
A scoping review (ScR) protocol is reported, adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement and guided by The Joanna Briggs Institute. MEDLINE/PubMed, Cochrane Library, Embase, CINAHL, Web of Science, Scopus, Science Direct and Latin American and Caribbean Health Sciences Literature, plus additional sources: The ProQuest Dissertation & Theses Global, The British Library, Google Scholar, medRXiv, ClinicalTrials.gov and WHO-ICTRP will be searched. No date or language restrictions will be employed. Two independent researchers will conduct all the steps of this ScR. The findings will be presented through tables, charts, narrative summaries and assessed based on the outcomes. The search strategy will be updated in May 2022. The expected completion date for this ScR is November 2022.

Ethics/dissemination
This protocol does not require ethical approval. The dissemination plans comprise peer-reviewed publication and conference presentations, to be shared with International Oncology Societies/International Nursing Societies and advisory groups to inform discussions on future research. We expect that our results will be of interest to nurse professionals, especially, PON and nurse scholars concerned with this particular issue.

Introduction
Spinal cord injury (SCI) leads to significant changes in morbidity, mortality and quality of life (QOL). Currently, there are no effective therapies to restore function after chronic SCI. Preliminary studies have indicated that epidural spinal cord stimulation (eSCS) is a promising therapy to improve motor control and autonomic function for patients with chronic SCI. The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function. Our secondary objective is to optimise spinal cord stimulation parameters for volitional movement.

Methods and analysis
The Epidural Stimulation After Neurologic Damage (ESTAND) trial is a phase II single-site self-controlled trial of epidural stimulation with the goal of restoring volitional movement and autonomic function after motor complete SCI. Participants undergo epidural stimulator implantation and are followed up over 15 months while completing at-home, mobile application-based movement testing. The primary outcome measure integrates quantity of volitional movement and similarity to normal controls using the volitional response index (VRI) and the modified Brain Motor Control Assessment. The mobile application is a custom-designed platform to support participant response and a kinematic task to optimise the settings for each participant. The application optimises stimulation settings by evaluating the parameter space using movement data collected from the tablet application and accelerometers. A subgroup of participants with cardiovascular dysautonomia are included for optimisation of blood pressure stabilisation. Indirect effects of stimulation on cardiovascular function, pain, sexual function, bowel/bladder, QOL and psychiatric measures are analysed to assess generalisability of this targeted intervention.

Ethics and dissemination
This study has been approved after full review by the Minneapolis Medical Research Foundation Institutional Review Board and by the Minneapolis VA Health Care System. This project has received Food and Drug Administration investigational device exemption approval. Trial results will be disseminated through peer-reviewed publications, conference presentations and seminars.

Trial registration number
NCT03026816.

Introduction
Vaginal progesterone supplementation is frequently given to patients receiving frozen embryo transfer (FET) in the natural cycle aiming to increase the chance of pregnancy and live birth. To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low.

Methods and analysis
The ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. Participants are randomised (1:1:1) to either luteal phase progesterone for 3 weeks, luteal phase progesterone for 7 weeks or no luteal phase progesterone. The participating study centres consist of 12 in vitro fertilisation-clinics in Sweden and 1 in Iceland. The primary outcome is to investigate if luteal phase support (LPS) by vaginal progesterone increases the chance of a live birth per randomised patient in a natural FET cycle compared with no LPS.

Ethics and dissemination
The trial was approved by the Swedish Ethical Review Authority (ID 2020-06774, 2021-02822 and 2022-01502-02) and the Swedish Medical Products Agency (ID nr 5.1-2020-102613). All participants are required to provide written informed consent. The outcome of this study will be disseminated to the public through broadcasts, newspapers and presentations at scientific congresses as well as publications in international scientific journals.

Trial registration number
NCT04725864.

Introduction
Non-cystic fibrosis bronchiectasis (NCFB) brought a heavy healthcare burden worldwide. Macrolide maintenance therapy was proved to be helpful in reducing exacerbation of NCFB. However, the optimal dosing regimens of macrolides have not been determined, and its efficacy in Chinese NCFB population has not been validated. This protocol describes a head-to-head clinical trial designed to compare the efficacy of two dosing regimens of azithromycin in Chinese NCFB population.

Methods and analysis
This prospective, open-label and randomised controlled trial will be conducted in the First People’s Hospital of Jiashan, China. Eligible patients with high-resolution CT defined NCFB will be randomly divided into three groups, which will receive either 250 mg daily azithromycin, or 500 mg three-times-weekly azithromycin or no treatment for 6 months. They will be followed up for another 6 months without treatment. The primary outcome is the mean rate of protocol-defined pulmonary exacerbation at 6 months.

Ethics and dissemination
Ethical approval was obtained from the First People’s Hospital of Jiashan Ethics Committee. The findings will be disseminated in peer-reviewed publications.

Trial registration number
ChiCTR2100052906.

Introduction
The prevalence of diminished ovarian reserve (DOR), a common gynaecological disorder, is approximately 10% across the world. Failure in early diagnosis and treatment may result in continuous decreases in ovarian function and the resultant loss in an opportunity of pregnancy, which greatly affects the happiness of the women’s family and women’s physical and mental health. Nevertheless, there has been no effective treatment for such a disorder until now. Folic acid, a member of the vitamin B family, is involved in one-carbon cycle and methylation regulation. It has been found that folic acid affects the whole period of pregnancy, and folic acid supplementation has shown effective to remarkably reduce the incidence of fetal neural tube defects and decrease plasma homocysteic acid levels, thereby resulting in a decline in the incidence of abortion. In addition, folic acid is reported to mediate ovarian functions. It is therefore hypothesised that folic acid may improve DOR.

Methods and analysis
A single-centre, open-label, randomised, placebo-controlled clinical trial is designed. We plan to recruit 140 women with DOR at ages of 30–35 years. All participants will be randomised into the folic acid group and placebo group, and each subject will be given a tablet with the same appearance daily for 6 months. The primary outcome is antral follicle count, and the secondary outcomes are ovarian reserve markers, ovarian low-dose stimulation responses and safety.

Ethics and dissemination
This study was approved by the Ethics Review Committee of Nanping First Hospital Affiliated to Fujian Medical University on 10 February 2021 (approval number: NPSY202002042). Written informed consent was obtained from all participants prior to randomisation, following a detailed description of the purpose of the study. The results of this clinical trial will be presented at scientific conferences and submitted to a peer-reviewed journal.

Trial registration number
Chinese Clinical Trial Registry, ChiCTR2100047410.

This Viewpoint addresses the need for accessible dermatologic care in rural areas of the US and discusses the development and implementation of strategies for expanding access to care.

Introduction
Oxygen is an essential medicine for children and adults. The current systems for its delivery can be expensive and unreliable in settings where oxygen is most needed. FREO2 Foundation Australia has developed an integrated oxygen system, driven by a mains-powered oxygen concentrator, with the ability to switch automatically between low-pressure oxygen storage device and cylinder oxygen in power interruptions. The aim of this study is to assess the clinical impact and cost-effectiveness of expanding this system to 20 community and district hospitals and level IV facilities in Western Uganda.

Methods and analysis
This will be a phased implementation with preintervention and postintervention comparison of outcomes. Standardised baseline data collection and needs assessment will be conducted, followed by implementation of the FREO2 Oxygen System in combination with pulse oximetry in 1–2 facilities per month over a 16-month period, with a total 23-month data collection period. The primary outcome will be the proportion of hypoxaemic children receiving oxygen pre and post oxygen system. Secondary outcomes will assess clinical, economic and technical aspects. Pre and post oxygen system primary and secondary outcomes will be compared using regression models and standard tests of significance. Useability will be quantitatively and qualitatively evaluated in terms of acceptability, feasibility and appropriateness, using standardised implementation outcome measure tools.

Ethics and dissemination
Ethics approval was obtained from Mbarara University of Science and Technology (MUREC 1/7) and the University of Melbourne (2021-14489-13654-2). Outcomes will be presented to the involved facilities, and to representatives of the Ministry of Health, Uganda. Broader dissemination will include publication in peer-reviewed journals and academic conference presentations.

Trial registration number
ACTRN12621000241831.

Objective
Measuring access and preferences to Men who have Sex with Men focused community-based HIV testing sites (MSM-CBTS) in Côte d’Ivoire.

Design
A respondent-driven sampling telephone survey.

Setting
National survey conducted in 2018 in Côte d’Ivoire.

Participants
518 MSM aged over 18 years old.

Primary and secondary outcome measures
Knowledge, practices, satisfaction and preferences regarding MSM-CBTS. Factors associated with MSM-CTBS access or knowledge and with HIV testing venue preferences were examined.

Results
Only half of the respondents (47%) reported knowing of an MSM-CBTS. Of these, 79% had already attended one. Both knowing of and ever visiting an MSM-CBTS were significantly associated with a higher number of HIV tests performed in the past 12 months and having disclosed sexual orientation to one family member.
In terms of preferences, 37% of respondents said they preferred undifferentiated HIV testing sites (ie, ‘all patients’ HIV testing sites), 34% preferred MSM-CBTS and 29% had no preference.
Those who reported being sexually attracted to women, being bisexual and those who did not know an MSM non-governmental organisation were less likely to prefer MSM-CBTS. MSM who preferred undifferentiated HIV testing sites mentioned the lack of discretion and anonymity of community-based sites and the desire to avoid the gaze of others.

Conclusion
Community-based HIV testing is well suited for MSM who identify as homosexual and those close to the MSM community, while maintaining undifferentiated HIV testing is essential for others. Both types of activities need to be maintained and developed. Healthcare professionals in undifferentiated HIV testing sites need to be properly trained in the non-judgemental reception of MSM.

Stroke, Volume 53, Issue 7, Page e362-e362, July 1, 2022.

Introduction
At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap.

Methods and analysis
This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56–80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences—Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery.

Ethics and dissemination
The study received the following approvals: South Central—Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers.

Trial registration number
ISRCTN93895792.

Introduction
Laparoscopic colectomy has been widely used clinically due to its minimally invasive advantages, and many studies have also demonstrated its safety and efficacy. However, the efficacy of laparoscopic left hemicolectomy remains unclear due to the differences in pathogenesis and surgical details between left and right colon cancers. Therefore, we plan to conduct a systematic review and meta-analysis to investigate whether laparoscopic techniques can be safely used in left hemicolectomy.

Method and analysis
This meta-analysis protocol will be completed and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A systematic search was performed for all articles related to laparoscopic left hemicolectomy in PubMed, Web of Science, Medline, EMBASE and the Cochrane Library from inception to 5 November 2021. Article screening and data extraction were performed independently by two authors and cross-checked after completion. The literature to be included will use corresponding tools for bias risk assessment. Subgroup analyses and sensitivity analyses will be used to explore potential heterogeneity.

Ethics and dissemination
Because this systematic review is based on studies with published results and does not involve intervention in patients, no ethical review is required. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42022291526.

Introduction
Postoperative delirium is common in older cardiac surgery patients and associated with negative short-term and long-term outcomes. The alpha-2-adrenergic receptor agonist dexmedetomidine shows promise as prophylaxis and treatment for delirium in intensive care units (ICU) and postoperative settings. Clonidine has similar pharmacological properties and can be administered both parenterally and orally. We aim to study whether repurposing of clonidine can represent a novel treatment option for delirium, and the possible effects of dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns and biomarkers of neuronal injury, and whether these effects are associated with frailty status.

Methods and analysis
This five-centre, double-blind randomised controlled trial will include 900 cardiac surgery patients aged 70+ years. Participants will be randomised 1:1:1 to dexmedetomidine or clonidine or placebo. The study drug will be given as a continuous intravenous infusion from the start of cardiopulmonary bypass, at a rate of 0.4 µg/kg/hour. The infusion rate will be decreased to 0.2 µg/kg/hour postoperatively and be continued until discharge from the ICU or 24 hours postoperatively, whichever happens first.
Primary end point is the 7-day cumulative incidence of postoperative delirium (Diagnostic and Statistical Manual of Mental Disorders, fifth edition). Secondary end points include the composite end point of coma, delirium or death, in addition to delirium severity and motor activity patterns, levels of circulating biomarkers of neuronal injury, cognitive function and frailty status 1 and 6 months after surgery.

Ethics and dissemination
This trial is approved by the Regional Committee for Ethics in Medical Research in Norway (South-East Norway) and by the Norwegian Medicines Agency. Dissemination plans include publication in peer-reviewed medical journals and presentation at scientific meetings.

Trial registration number
NCT05029050.

Objectives
Through analysis of claims and payment data, we quantified several implications of shifting ancillary healthcare services from regulated, more expensive to unregulated, less expensive sites. We also quantified the implications of this shift on access to services, with a focus on differences in access between rural and urban patients for a Medicaid (disadvantaged) population in Maryland, USA.

Design
Using a dataset of all Medicaid claims records for 1 year, we identified and extracted all bundles of regulated and unregulated ancillary services. Geospatial computing was used to approximate transportation costs required to access services. Including transportation enabled us to estimate net savings of any added transportation costs. We used location-allocation optimisation models to find the optimal sites to minimise net costs.

Setting
Coverage area included Medicaid patients throughout the state of Maryland.

Participants
All rural and urban members of this Medicaid cohort.

Primary and secondary outcome measures
Change in payer costs and member travel times on shifting ancillary bundles from regulated to unregulated sites.

Results
Procedure cost and travel time differentials between regulated and unregulated sites strongly correlated with the percentage of procedures referred to regulated sites. Shifting regulated bundles to unregulated sites, while imposing the constraint of no increase in travel time, reduced expenditures by 15.9%. This figure exceeded 30% if no limit was placed on travel-time increases.

Conclusion
With reasonable constraints on allowable travel time increases, shifting ancillary service bundles from regulated to unregulated sites can benefit both patients and payers in terms of cost and access.