JAMA Oncology

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.

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Ottobre 2024

Identifying markers of health-seeking behaviour and healthcare access in UK electronic health records

Objective
To assess the feasibility of identifying markers of health-seeking behaviour and healthcare access in UK electronic health records (EHR), for identifying populations at risk of poor health outcomes and adjusting for confounding in epidemiological studies.

Design
Cross-sectional observational study using the Clinical Practice Research Datalink Aurum prelinked to Hospital Episode Statistics.

Setting
Individual-level routine clinical data from 13 million patients across general practices (GPs) and secondary data in England.

Participants
Individuals aged ≥66 years on 1 September 2019.

Main outcome measures
We used the Theory of Planned Behaviour (TPB) model and the literature to iteratively develop criteria for markers selection. Based on this we selected 15 markers: those that represented uptake of public health interventions, markers of active healthcare access/use and markers of lack of access/underuse. We calculated the prevalence of each marker using relevant lookback periods prior to the index date (1 September 2019) and compared with national estimates. We assessed the correlation coefficients (phi) between markers with inferred hierarchical clustering.

Results
We included 1 991 284 individuals (mean age: 75.9 and 54.0% women). The prevalence of markers ranged from

Leggi
Settembre 2024

Traditional healing practices, factors influencing to access the practices and its complementary effect on mental health in sub-Saharan Africa: a systematic review

Objectives
In areas with limited and unaffordable biomedical mental health services, such as sub-Saharan Africa (SSA), traditional healers are an incredibly well-used source of mental healthcare. This systematic review synthesises the available evidence on traditional healing practices, factors to access it and its effectiveness in improving people’s mental health in SSA.

Design
Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach.

Data sources
PubMed, MEDLINE, CINAHL and Scopus studies published before 1 December 2022.

Eligibility criteria
Qualitative and quantitative studies reported traditional healing practices to treat mental health problems in SSA countries published in English before 1 December 2022.

Data extraction and synthesis
Data were extracted using Covidence software, thematically analysed and reported using tables and narrative reports. The methodological quality of the included papers was evaluated using Joanna Briggs Institute quality appraisal tools.

Results
In total, 51 studies were included for analysis. Traditional healing practices included faith-based (spiritual or religious) healing, diviner healing practices and herbal therapies as complementary to other traditional healing types. Objectively measured studies stated that people’s mental health improved through collaborative care of traditional healing and biomedical care services. In addition, other subjectively measured studies revealed the effect of traditional healing in improving the mental health status of people. Human rights abuses occur as a result of some traditional practices, including physical abuse, chaining of the patient and restriction of food or fasting or starving patients. Individual, social, traditional healers, biomedical healthcare providers and health system-related factors were identified to accessing traditional healing services.

Conclusion
Although there is no conclusive, high-level evidence to support the effectiveness of traditional healing alone in improving mental health status. Moreover, the included studies in this review indicated that traditional healing and biomedical services collaborative care improve people’s mental health.

PROSPERO registration number
CRD42023392905.

Leggi
Settembre 2024

Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial

Introduction
The high incidence of morbidity and mortality associated with the post-cardiac arrest (CA) period highlights the need for novel therapeutic interventions to improve the outcome of out-of-hospital cardiac arrest (OHCA) patients admitted to the intensive care unit (ICU). The aim of this study is to assess the ability of high-dose intravenous vitamin C (Vit-C) to improve post-CA shock.

Methods and analysis
This is a single-blind, open-label, multicentre, randomised controlled trial, involving 234 OHCA patients with post-CA shock planned to be enrolled in 10 French ICUs. Patients will be randomised to receive standard-of-care (SOC) or SOC with early high-dose intravenous Vit-C administration (200 mg/kg per day, within 6 hours after return of spontaneous circulation, for 3 days). The primary endpoint is the cumulative incidence of vasopressor withdrawal at 72 hours after enrolment, with death considered as a competing event. The main secondary endpoints are neurological outcome, mortality due to refractory shock, vasopressor-free days and organ failure monitored by the sequential organ failure assessment score.

Ethics and dissemination
The study protocol was approved by a French Ethics Committee (EC) on 21 February 2023 (Comité de Protection des Personnes Ile de France 1, Paris, France). Due to the short enrolment period to avoid any delay in treatment, the EC approved the study inclusion before informed consent was obtained. As soon as possible, patient and their relative will be asked for their deferred informed consent. The data from the study will be disseminated through conference presentations and peer-reviewed publications.

Trial registration number
NCT05817851.

Leggi
Settembre 2024

[Articles] Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy for initially unresectable locally advanced colon cancer: short-term outcomes of an open-label, single-centre, randomised, controlled, phase 3 trial

Adding radiation to NACT increased the R0 resection rate, prolonged the PFS, and potentially improved OS in selected patients with initially unresectable LACC. The trial findings indicate that this approach is safe, feasible, and may confer a survival benefit.

Leggi
Settembre 2024

Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2)

Introduction
Several randomised controlled trials have demonstrated that novel oral anticoagulants are safer compared with vitamin K antagonists for the management of non-valvular atrial fibrillation (NVAF) to prevent thromboembolic events in the general population. There is a growing interest in the use of apixaban in patients with end-stage renal disease (ESRD) undergoing peritoneal dialysis (PD) but there is a lack of randomised data in this population.

Methods and analysis
APIDP2 is a prospective parallel, randomised, open-label, blinded endpoint trial involving patients with ESRD undergoing chronic PD who have NVAF. A total of 178 participants will be recruited from 20 French PD centres. Eligible patients will be randomly assigned to receive either apixaban at a reduced dose of 2.5 mg two times per day (dose determined with the previous pharmacokinetic study APIDP1) or dose-adjusted to international normalised ratio (INR) target (2–3) coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of 1 year. The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to month 12, assessed according to the International Society on Thrombosis and Haemostasis Score. Secondary outcomes encompass an efficacy composite criterion combining stroke or transient ischaemic attack (TIA), cardiovascular death and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) and Thrombolysis In Myocardial Infarction (TIMI) criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of 2–3 in the warfarin arm over 1 year, and anti-Xa apixaban activity in case of bleeding events and at 1 month, 6 months and 12 months of follow-up in the apixaban arm. To demonstrate that apixaban is safer than warfarin at 1 year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Study among patients with creatinine clearance 25–30 ml/min), that is, 89 patients per group.

Ethics and dissemination
The study has been approved by the ethics committee Comité de Protection des Personnes Sud Est III – Lyon – FRANCE, CT number 2023-507544-37-00. Written informed consent is required for each participant. Findings will be presented at scientific meetings and published in peer-reviewed journals.

Trial registration
ClinicalTrials.gov, NCT06045858; European Clinical Trial System, CT number 2023-507544-37-00.

Leggi
Settembre 2024

Clinical effectiveness of robotic versus laparoscopic and open surgery: an overview of systematic reviews

Objective
To undertake a review of systematic reviews on the clinical outcomes of robotic-assisted surgery across a mix of intracavity procedures, using evidence mapping to inform the decision makers on the best utilisation of robotic-assisted surgery.

Eligibility criteria
We included systematic reviews with randomised controlled trials and non-randomised controlled trials describing any clinical outcomes.

Data sources
Ovid Medline, Embase and Cochrane Library from 2017 to 2023.

Data extraction and synthesis
We first presented the number of systematic reviews distributed in different specialties. We then mapped the body of evidence across selected procedures and synthesised major findings of clinical outcomes. We used a measurement tool to assess systematic reviews to evaluate the quality of systematic reviews. The overlap of primary studies was managed by the corrected covered area method.

Results
Our search identified 165 systematic reviews published addressing clinical evidence of robotic-assisted surgery. We found that for all outcomes except operative time, the evidence was largely positive or neutral for robotic-assisted surgery versus both open and laparoscopic alternatives. Evidence was more positive versus open. The evidence for the operative time was mostly negative. We found that most systematic reviews were of low quality due to a failure to deal with the inherent bias in observational evidence.

Conclusion
Robotic surgery has a strong clinical effectiveness evidence base to support the expanded use of robotic-assisted surgery in six common intracavity procedures, which may provide an opportunity to increase the proportion of minimally invasive surgeries. Given the high incremental cost of robotic-assisted surgery and longer operative time, future economic studies are required to determine the optimal use of robotic-assisted surgery capacity.

Leggi
Settembre 2024

Change to Open Access

For the Original Investigation titled “Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: the FOCUS Randomized Clinical Trial,” published online June 3, 2024, the publication status was changed to open access (CC-BY). This article has been corrected online.

Leggi
Settembre 2024

JAMA Oncology

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.

Leggi
Settembre 2024

Change to Open Access

For the Original Investigation titled “Polygenic Scores and Networks of Psychopathology Symptoms,” published on June 12, 2024, the publication status was changed to open access (CC-BY). This article was corrected online.

Leggi
Settembre 2024