Risultati per: Cardio-oncology: rivista open access

Introduction
Supervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of time-limited SIOT using injectable hydromorphone delivered in an existing Australian public opioid treatment programme, with secondary outcomes of safety, cost, changes in drug use and other health outcomes. If feasible, the goal is to scale up the intervention to be more widely available in Australia.

Methods and analysis
Between 20 and 30 participants will be offered two times per day hydromorphone to inject under direct observation, in addition to their current opioid agonist treatment (OAT), for up to 2 years. At the end of 2 years of supervised hydromorphone treatment, participants will be continued on standard OAT only. Informed consent will be obtained from all participants included in the study. This is a single-site, uncontrolled, open-label study where quantitative and qualitative interview data will be collected at baseline, 12 months and lastly at 3 months following their final hydromorphone dose. The main outcome measures are feasibility, as assessed by recruitment, retention and participation in treatment, and acceptability to participants, clinic staff and other stakeholders assessed by qualitative interviews. Secondary outcome measures of safety, as assessed by adverse events, and cost will also be assessed, as well as a range of other drug and health outcomes.

Ethics and dissemination
This study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2019/ETH00418). This will be the first study of time-limited SIOT in the Australian setting. All results will be submitted to peer-reviewed journals, scientific conferences and local practice meetings. A preliminary report on outcomes will also be presented to local health policy makers. A consumer and community forum will also be held to feedback results to a broader audience.

Trial registration number
ACTRN12621001729819.

The Original Investigation titled “Clinical Decision Support for Hypertension Management in Chronic Kidney Disease: A Randomized Clinical Trial,” published online March 11, 2024, has been updated to be an open-access article.

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.

For the Original Investigation titled “Postrecurrence Treatment in Neoadjuvant or Adjuvant FDA Registration Trials: A Systematic Review,” published online June 20, 2024, the publication status was changed to open access (CC-BY). This article has been corrected online.

Introduction
Postoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1–2N1M0 cohort with a low clinical risk of local–regional recurrence (LRR), has incited a discourse surrounding personalised treatment strategies. Multigene testing for Recurrence Index (RecurIndex) model capably differentiates patients based on their level of LRR risk. This research aims to validate whether a more aggressive treatment approach can enhance clinical outcomes in N1 patients who possess a clinically low risk of LRR, yet a high RecurIndex-determined risk of LRR. Specifically, this entails postoperative whole breast irradiation combined with regional lymph node irradiation (RNI) following breast-conserving surgery or chest wall irradiation with RNI after mastectomy.

Methods and analysis
The RIGAIN (RecurIndex-Guided postoperative radiotherapy with or without Avoidance of Irradiation of regional Nodes in 1–3 node-positive breast cancer) Study is a multicentre, prospective, randomised, open-label, phase III clinical trial that is being conducted in China. In this study, patients with low clinical LRR risk but high RecurIndex-LRR risk are randomly assigned in a 1:1 ratio to the experimental group or the control group. In the experimental group, RNI is performed and the control group omits RNI. Efficacy and safety analyses will be conducted, enrolling a total of 540 patients (270 per group). The primary endpoint is invasive disease-free survival, and secondary endpoints include any first recurrence, LRR-free survival, distant metastasis-free survival, recurrence-free survival, overall survival, disease-free survival, breast cancer-specific mortality and assessment of patient quality of life. The study began in April 2023 and with a follow-up period of 60 months after the last participant completes radiation therapy.

Ethics and dissemination
The study was approved by the Ethics Committee of Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University (SYSKY-2022-097-02, V.3.1). It adheres to the Helsinki Declaration and Good Clinical Practice. Research findings will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04069884.

Introduction
With the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments’ efficacy and toxicity is drawing more attention. Mobile phone interventions may be a practical solution to support patients taking OAMs at home, yet evidence to inform the efficacy of these interventions is lacking. The safety and adherence to medications and self-care advice in oncology (SAMSON) pilot randomised control trial (RCT) aims to evaluate the acceptability, feasibility and potential efficacy of a novel digital solution to improve medication adherence (MA) among people with cancer.

Methods and analysis
This is a two-arm, 12-week, pilot RCT aiming to enrol 50 adults with haematological, lung or melanoma cancers at an Australian metropolitan specialised oncology hospital, who are taking oral anti-cancer medicines. Participants will be randomised (1:1 allocation ratio) to either the intervention group (SAMSON solution) or the control group (usual care). The primary outcomes are the acceptability and feasibility of SAMSON. The secondary outcomes are MA, toxicity self-management, anxiety and depressive symptoms, health-related quality of life, and parameters relating to optimal intervention strategy. Quantitative data will be analysed on a modified intention-to-treat basis.

Summary
While multicomponent interventions are increasingly introduced, SAMSON incorporates novel approaches to the solution. SAMSON provides a comprehensive, patient-centred, digital MA intervention solution with seamless integration of a mobile platform with clinical consultations that are evidence-based, theory-based, co-designed and rigorously tested. The pilot trial will determine whether this type of intervention is feasible and acceptable in oncology and will provide a foundation for a future full-scale RCT.

Ethics and dissemination
Primary ethics approvals were received from Peter MacCallum Cancer Centre and Swinburne University of Technology Human Research Ethics Committees (HREC/95332/PMCC and 20237273–15836). Results will be disseminated via peer-reviewed publications and presentations at international and national conferences.

Trial registration number
The protocol has been prospectively registered on the Australian New Zealand Clinical Trials Registry with trial registration number (ACTRN12623000472673).

Introduction
Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder pain. Currently, exercise is proposed as the first-line treatment for patients suffering from RCRSP. However, adherence to therapeutic exercise programmes can be poor in the long term in a home setting. The aim of this study is to evaluate the effects of adding video animations to a traditional paper-based exercise programme.

Methods and analysis
A single-centre, randomised, open-labelled clinical trial will be conducted in a hospital in Spain. Adults aged between 18 and 80 years diagnosed with RCRSP who meet the eligibility criteria will be included. Patients (n=132) will be randomised into two groups, with both receiving paper-based exercises, and the experimental group will also be provided with video animations. The participants will receive seven face-to-face physical therapy sessions and will be asked to perform the exercises at home for 6 months. The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary outcomes will be the patient’s pain intensity during the last week (rest, during movement and at night); expectations of improvement; satisfaction with treatment; impression of improvement; perceived usability, usefulness and satisfaction of multimedia animations; and adherence to exercises. Generalised least squares regression models with an autoregressive-moving average lag one correlation structure will be implemented, with an intention-to-treat analysis.

Ethics and dissemination
This study has been approved by the ethics committee of Hospital Universitario Fundación Alcorcón (Madrid, Spain), reference number CI18/16. All participants will sign an informed consent. The results will be published in a peer-reviewed scientific journal.

Trial registration
ClinicalTrials.gov, NCT05770908.

Objectives
To assess the impact of a patient-based self-assessed fatigue intervention aimed at promoting early postoperative ambulation.

Design
Prospective randomised controlled trial.

Setting
Single-centre, conducted at the Obstetrics and Gynaecology Department of the Xiangyang Central Hospital, China.

Participants
Eligible were adult patients undergoing elective gynaecologic oncologic surgery.

Interventions
The intervention group utilised a modified Borg Rating of Perceived Experience (RPE) scale for self-assessment of fatigue levels. The control group followed fixed-activity distance guidelines postoperatively.

Primary and secondary outcome measures
The primary outcome was the self-reported the time to first flatus postoperatively. Secondary outcomes encompassed the time to first defecation, incidence of moderate-to-severe abdominal distention, ileus, postambulation adverse events (nausea, vomiting and dizziness), patient satisfaction with early ambulation instructions, compliance with early ambulation and average hospital costs and length of stay.

Results
Between June 2021 and October 2022, 552 patients were enrolled. The self-assessed fatigue intervention group demonstrated non-inferior the time to first flatus compared with the fixed-activity distance assessment group (25.59±14.59 hours vs 26.10±14.19 hours, pnon-inferiority

Objectives
Identifying key barriers to accessing quality-assured and affordable antimicrobials among forcibly displaced persons in Uganda, Yemen and Colombia and investigating their (1) utilisation patterns of antibiotics, (2) knowledge about antimicrobial resistance (AMR) and (3) perception of the quality of antimicrobials received.

Design
Pilot cross-sectional survey.

Setting
Data were collected from five health facilities in the Kiryandongo refugee settlement (Bweyale, Uganda), three camps for internally displaced persons (IDPs) in the Dar Sad district (Aden, Yemen) and a district with a high population of Venezuelan migrants (Kennedy district, Bogotá, Colombia). Data collection took place between February and May 2021. The three countries were selected due to their high number of displaced people in their respective continents.

Participants
South Sudanese refugees in Uganda, IDPs in Yemen and Venezuelan migrants in Colombia.

Outcome measure
The most common barriers to access to quality-assured and affordable antimicrobials.

Results
A total of 136 participants were enrolled in this study. Obtaining antimicrobials through informal pathways, either without a doctor’s prescription or through family and friends, was common in Yemen (27/50, 54.0%) and Colombia (34/50, 68.0%). In Yemen and Uganda, respondents used antibiotics to treat (58/86, 67.4%) and prevent (39/86, 45.3%) a cold. Knowledge of AMR was generally low (24/136, 17.6%). Barriers to access included financial constraints in Colombia and Uganda, prescription requirements in Yemen and Colombia, and non-availability of drugs in Uganda and Yemen.

Conclusion
Our multicentred research identified common barriers to accessing quality antimicrobials among refugees/IDPs/migrants and common use of informal pathways. The results suggest that knowledge gaps about AMR may lead to potential misuse of antimicrobials. Due to the study’s small sample size and use of non-probability sampling, the results should be interpreted with caution, and larger-scale assessments on this topic are needed. Future interventions designed for similar humanitarian settings should consider the interlinked barriers identified.

Introduction
Persons with mild and moderate intellectual disability (MMID) have the right to participate in all aspects of society and be afforded equal opportunities to realise their full potential. However, it is a challenge for persons with MMID to find and maintain employment due to many different barriers. Currently, there is no contextually relevant framework in South Africa that considers the unique employment support needs and accommodation of persons with MMID, which can guide and inform the transition to employment interventions, strategies and national policy directives.

Methods and analysis
The proposed scoping review will be guided by the methodological framework developed by a working group from the Joanna Briggs Institute (JBI) and the JBI Collaboration. The search for relevant studies will be conducted across 12 research databases. Reference mining of review studies will be conducted. A three-step search strategy will be used, including the use of information management software to manage the search results. Three independent reviewers will screen the full-text studies to finalise the list of included and excluded studies. Included studies will be assessed for methodological quality using a critical appraisal tool. Data will be charted by one independent reviewer and assessed by two independent reviewers, using a data charting instrument. The data chart will be presented using tables and charts describing the demographic features of the reviewed studies, with an explanation of the thematically analysed results.

Ethics and dissemination
This scoping review has received ethical approval (BM22/10/11). A summary of the findings of the study will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding of the key characteristics or factors underpinning the components of a multilevel transition to employment framework that will result in open labour market employment for persons with MMID.

Since the turn of this century, fatal drug overdoses involving opioids have continued to mount. Despite rhetorical assertions to the contrary, too little investment has been made in the science-based responses to this crisis and progress has been stymied by systems-level factors.

Objectives
Provision of personalised care planning is a national priority for people with dementia. Research suggests a lack of quality and consistency of care plans and reviews. The PriDem model of care was developed to deliver feasible and acceptable primary care-based postdiagnostic dementia care. We aimed to increase the adoption of personalised care planning for people with dementia, exploring implementation facilitators and barriers.

Design
Mixed-method feasibility and implementation study.

Setting
Seven general practices from four primary care networks (PCNs) in the Northeast and Southeast of England.

Participants
A medical records audit collected data on 179 community-dwelling people with dementia preintervention, and 215 during the intervention year. The qualitative study recruited 26 health and social care professionals, 14 people with dementia and 16 carers linked to participating practices.

Intervention
Clinical dementia leads (CDL) delivered a 12-month, systems-level intervention in participating PCNs, to develop care systems, build staff capacity and capability, and deliver tailored care and support to people with dementia and their carers.

Primary and secondary outcome measures
Adoption of personalised care planning was assessed through a preintervention and postintervention audit of medical records. Implementation barriers and facilitators were explored through semistructured qualitative interviews and non-participant observation, analysed using codebook thematic analysis informed by Normalisation Process Theory.

Results
The proportion of personalised care plans increased from 37.4% (95% CI 30.3% to 44.5%) preintervention to 64.7% (95% CI 58.3% to 71.0%) in the intervention year. Qualitative findings suggest that the flexible nature of the PriDem intervention enabled staff to overcome contextual barriers through harnessing the skills of the wider multidisciplinary team, delivering increasingly holistic care to patients.

Conclusions
Meaningful personalised care planning can be achieved through a team-based approach. Although improved guidelines for care planning are required, commissioners should consider the benefits of a CDL-led approach.

Trial registration number
ISRCTN11677384.

Objective
Billions of vascular access devices (VADs) are inserted annually for intravenous therapy worldwide. However, their use is not without challenges. Facilitating the process and enhancing results, hospital authorities have created vascular access specialist teams (VASTs) with advanced competencies in the evaluation, insertion, care and management of VADs. The objective is to compare the effectiveness of VASTs versus standard practice regarding cannulation success and vascular access maintenance in hospitalised adults.

Design
Systematic review, using the Mixed Methods Appraisal Tool.

Data sources
We conducted a structured data search on Cochrane Library, MEDLINE, Web of Science, Scopus and EBSCOhost up to 31 May 2023. We did not impose a time limit regarding the date of publication.

Eligibility criteria
Studies were eligible for inclusion in the review if they were randomised and non-randomised trials and observational studies.

Data extraction and synthesis
We included studies that described or evaluated the activity of VASTs compared with clinical practitioners. The outcomes analysed were the success of the cannulation and the incidence of associated adverse effects.

Results
The search strategy produced 3053 papers published between 1984 and 2020, from which 12 were selected for analysis. VASTs are heterogeneously described among these studies, which mainly focus on insertions, frequently for patients with difficult intravenous access. Some patients presented with specific needs or requirement for specific insertion technique or catheter type. Compared with usual practice, these studies indicate that the involvement of a VAST is associated with a higher effectiveness in terms of first attempt insertions and insertion success rates, and a reduction in catheter-associated adverse events. However, meta-analyses confirming this trend are not currently possible.

Conclusions
It seems apparent that VASTS contribute to improving the health of patients during the administration of intravenous. VASTs seem to increase the effectiveness of VAD insertion and care and reduce complications.

PROSPERO registration number
CRD42021231259.

Introduction
Laparoscopic proximal gastrectomy with double flap technique (LPG-DFT) reconstruction has been used for proximal early gastric cancer in recent years. However, its feasibility and safety remain uncertain, as only a few retrospective studies have contained postoperative complications and long-term survival data. LPG-DFT for proximal early gastric cancer is still in the early stages of research. Large-scale, prospective randomised controlled trials (RCTs) are necessary to assess the value of LPG-DFT for proximal early gastric cancer.

Methods and analysis
This study is a multicentre, prospective, open-label, RCT that investigates the antireflux effect of LPG-DFT compared with laparoscopic total gastrectomy with Roux-en-Y (LTG-RY) reconstruction for proximal early gastric cancer. A total of 216 eligible patients will be randomly assigned to the LPG-DFT group or the LTG-RY group at a 1:1 ratio using a central, dynamic and stratified block randomisation method, if inclusion criteria are met. General and clinical data will be collected when the patient is enrolled in the study and keep pace with the patient at each stage of his medical and follow-up pathway. The primary endpoint is the proportion of patients with reflux esophagitis (Los Angeles Grade B or more) within 12 months postoperatively. The secondary endpoints included intraoperative outcomes, postoperative recovery, postoperative pain assessment, pathological outcomes, postoperative quality of life, postoperative nutrition status, morbidity and mortality rate, and oncological outcomes (3-year overall survival (OS), 3-year disease-free survival (DFS), 5-year DFS and 5-year OS).

Ethics and dissemination
The protocol is approved by the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ethics committee (registration number: SYSKY-2022-276-02) on 28 September 2022.We will report the positive as well as negative findings in international peer-reviewed journals.

Trial registration number
NCT05890339.

Rationale
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.

Methods
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.

Ethics and dissemination
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04693403.

Protocol version
8 September 2023; version 5.