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
Luglio 2024

Norepinephrine weaning guided by the Hypotension Prediction Index in vasoplegic shock after cardiac surgery: protocol for a single-centre, open-label randomised controlled trial – the NORAHPI study

Introduction
Norepinephrine (NE) is the first-line recommended vasopressor for restoring mean arterial pressure (MAP) in vasoplegic syndrome (vs) following cardiac surgery with cardiopulmonary bypass. However, solely focusing on target MAP values can lead to acute hypotension episodes during NE weaning. The Hypotension Prediction Index (HPI) is a machine learning algorithm embedded in the Acumen IQ device, capable of detecting hypotensive episodes before their clinical manifestation. This study evaluates the clinical benefits of an NE weaning strategy guided by the HPI.

Material and analysis
The Norahpi trial is a prospective, open-label, single-centre study that randomises 142 patients. Inclusion criteria encompass adult patients scheduled for on-pump cardiac surgery with postsurgical NE administration for vs patient randomisation occurs once they achieve haemodynamic stability (MAP >65 mm Hg) for at least 4 hours on NE. Patients will be allocated to the intervention group (n=71) or the control group (n=71). In the intervention group, the NE weaning protocol is based on MAP >65 mmHg and HPI65 mm Hg in the control group. Successful NE weaning is defined as achieving NE weaning within 72 hours of inclusion. An intention-to-treat analysis will be performed. The primary endpoint will compare the duration of NE administration between the two groups. The secondary endpoints will include the prevalence, frequency and time of arterial hypotensive events monitored by the Acumen IQ device. Additionally, we will assess cumulative diuresis, the total dose of NE, and the number of protocol weaning failures. We also aim to evaluate the occurrence of postoperative complications, the length of stay and all-cause mortality at 30 days.

Ethics and dissemination
Ethical approval has been secured from the Institutional Review Board (IRB) at the University Hospital of Amiens (IRB-ID:2023-A01058-37). The findings will be shared through peer-reviewed publications and presentations at national and international conferences.

Trial registration number
NCT05922982.

Leggi
Giugno 2024

Correction notice: priority strategies to reduce socio-gendered inequities in access to person-centred osteoarthritis care: Delphi survey

Iziduh S, Abenoja A, Theodorlis M, et al Priority strategies to reduce socio-gendered inequities in access to person-centred osteoarthritis care: Delphi survey. BMJ Open 2024;14:e080301. doi: 10.1136/bmjopen-2023-080301
The above mentioned article is corrected since it was published. The second author is changed from “Angela Abenoja” to “Angelina Abbaticchio”.

Leggi
Giugno 2024

Using mobile health to expedite access to specialty care for youth presenting to the emergency department with concussion at highest risk of developing persisting symptoms: a protocol paper for a non-randomised hybrid implementation-effectiveness trial

Introduction
Paediatric concussion is a common injury. Approximately 30% of youth with concussion will experience persisting postconcussion symptoms (PPCS) extending at least 1 month following injury. Recently, studies have shown the benefit of early, active, targeted therapeutic strategies. However, these are primarily prescribed from the specialty setting. Early access to concussion specialty care has been shown to improve recovery times for those at risk for persisting symptoms, but there are disparities in which youth are able to access such care. Mobile health (mHealth) technology has the potential to improve access to concussion specialists. This trial will evaluate the feasibility of a mHealth remote patient monitoring (RPM)-based care handoff model to facilitate access to specialty care, and the effectiveness of the handoff model in reducing the incidence of PPCS.

Methods and analysis
This study is a non-randomised type I, hybrid implementation-effectiveness trial. Youth with concussion ages 13–18 will be enrolled from the emergency department of a large paediatric healthcare network. Patients deemed a moderate-to-high risk for PPCS using the predicting and preventing postconcussive problems in paediatrics (5P) stratification tool will be registered for a web-based chat platform that uses RPM to collect information on symptoms and activity. Those patients with escalating or plateauing symptoms will be contacted for a specialty visit using data collected from RPM to guide management. The primary effectiveness outcome will be the incidence of PPCS, defined as at least three concussion-related symptoms above baseline at 28 days following injury. Secondary effectiveness outcomes will include the number of days until return to preinjury symptom score, clearance for full activity and return to school without accommodations. The primary implementation outcome will be fidelity, defined as the per cent of patients meeting specialty care referral criteria who are ultimately seen in concussion specialty care. Secondary implementation outcomes will include patient-defined and clinician-defined appropriateness and acceptability.

Ethics and dissemination
This study was approved by the Institutional Review Board of the Children’s Hospital of Philadelphia (IRB 22-019755). Study findings will be published in peer-reviewed journals and disseminated at national and international meetings.

Trial registration number
NCT05741411.

Leggi
Giugno 2024

Assessing the feasibility and acceptability of a diabetes-specific nurse-led multicomponent smoking cessation intervention in diabetes education: study protocol for an open-label pragmatic randomised controlled trial

Introduction
Smoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators.

Methods and analysis
This is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service’s one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses’ perceived challenges and facilitators to implementation and the nurses’ and patients’ acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals.

Ethics and dissemination
Ethical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal.

Trial registration number
NCT05920096.

Leggi
Giugno 2024

Applying ordered network analysis to video-recorded physician-nurse interactions to examine communication patterns associated with shared understanding in inpatient oncology care settings

Objectives
The main aim of this study was to demonstrate how ordered network analysis of video-recorded interactions combined with verbal response mode (VRM) coding (eg, edification, disclosure, reflection and interpretation) can uncover specific communication patterns that contribute to the development of shared understanding between physicians and nurses. The major hypothesis was that dyads that reached shared understanding would exhibit different sequential relationships between VRM codes compared with dyads that did not reach shared understanding.

Design
Observational study design with the secondary analysis of video-recorded interactions.

Setting
The study was conducted on two oncology units at a large Midwestern academic health care system in the USA.

Participants
A total of 33 unique physician–nurse dyadic interactions were included in the analysis. Participants were the physicians and nurses involved in these interactions during patient care rounds.

Primary and secondary outcome measures
The primary outcome measure was the development of shared understanding between physicians and nurses, as determined by prior qualitative analysis. Secondary measures included the frequencies, orders and co-occurrences of VRM codes in the interactions.

Results
A Mann-Whitney U test showed that dyads that reached shared understanding (N=6) were statistically significantly different (U=148, p=0.00, r=0.93) from dyads that did not reach shared understanding (N=25) in terms of the sequential relationships between edification and disclosure, edification and advisement, as well as edification and questioning. Dyads that reached shared understanding engaged in more edification followed by disclosure, suggesting the importance of this communication pattern for reaching shared understanding.

Conclusions
This novel methodology demonstrates a robust approach to inform interventions that enhance physician–nurse communication. Further research could explore applying this approach in other healthcare settings and contexts.

Leggi
Giugno 2024

Qualitative evaluation of digital vending machines to improve access to STI and HIV testing in South West England: using a Person-Based Approach

Objectives
To report the development, implementation, acceptability and feasibility of vending machines offering HIV and sexually transmitted infection (STI) testing kits.

Design
A qualitative study using the Person-Based Approach with patient and public involvement workshops and stakeholder involvement and interviews with machine users, sexual health service (SHS) staff, venue staff and local authority sexual health commissioners. Transcripts were analysed thematically.

Setting
Bristol, North Somerset and South Gloucestershire (BNSSG).

Participants
15 machine users, 5 SHS staff, 3 venue staff and 3 local authority commissioners.

Intervention
Four vending machines dispensing free HIV self-testing and STI self-sampling kits in publicly accessible venues across BNSSG were introduced to increase access to testing for groups at higher risk of HIV and STI infection who are less likely to access SHS clinic testing services (young people, people from black communities, and gay, bisexual and other men who have sex with men).

Results
Machine users reported the service was convenient, easy to use and accessible; however, concerns regarding privacy related to machine placement within the venues and issues of maintenance were raised. Promotional material was inclusive and informative; however, awareness of the service through the promotional campaign was limited. Vending machines were acceptable to venue staff once clear processes for their management were agreed with the SHS. SHS staff identified challenges with the implementation of the service related to the limited involvement of the whole SHS team in the planning and development.

Conclusions
The codeveloped vending machine service was acceptable, addressing some barriers to testing. Resources and protected staff time are needed to support greater involvement of the whole SHS team and service providers in venues. Adopting a similarly robust coproduction approach to the implementation of the machines could avoid the challenges reported. The placement of the machines to assure users privacy and repeated, targeted promotion could encourage service use among target groups.

Leggi
Giugno 2024

Utility, acceptability and applicability of a nucleic acid amplification test in comparison with a syndromic approach in the management of sexually transmitted diseases at Mulago National Referral Hospital in Uganda (ASTRHA): protocol for an open-label, randomised controlled trial

Introduction
Sexually transmitted diseases (STDs) are a major cause of long-term disability. Urethral discharge syndrome (UDS), abnormal vaginal discharge (AVD) and genital ulcer disease (GUD) are very common in low-income and middle-income countries (LMICs), where, due to lack of resources, these infections are managed according to a syndromic approach. Although microbiological diagnosis using nuclear acid amplification tests (NAAT) is already a standard to prescribe targeted treatments in industrialised countries, no randomised clinical trials have been conducted to evaluate clinical usefulness and acceptability of NAAT in comparison with syndromic approach in LMICs. The results of this study could inform diagnostic guidelines since they may suggest an update of the current recommendation if microbiological diagnosis using NAAT in the management of STD is demonstrated to be both useful and acceptable in an LMIC context.

Methods and analysis
The primary objective of this randomised, open-label trial is to evaluate the clinical usefulness of a NAAT and its acceptability in comparison with a clinical syndromic approach and to explore whether this test could replace the syndromic approach in the management of STDs at a national referral hospital in Uganda. 220 patients presenting to the STD clinic at Mulago Hospital in Kampala, Uganda with AVD, UDS or GUD will be randomised to either standard of care (syndromic management) or NAAT-based treatment with a 1:1 ratio. All the patients will be asked to return after 2 or 3 weeks for a control visit. Primary outcome will be therapeutic appropriateness.

Ethics and dissemination
This trial was approved by the Mulago Hospital Research and Ethical Committee (MHREC2023-97) and the Uganda National Council for Science and Technology (HS31000ES). Patients will give informed consent to participate before taking part in the study. Results will be published in peer-reviewed journals in open-access formats and data made available in anonymised form.

Trial registration number
NCT05994495.

Leggi
Giugno 2024

Neonatal Resuscitation Online Registry in Shenzhen: protocol for a prospective, multicentre, open, observational cohort study

Introduction
Preterm birth complications and neonatal asphyxia are the leading causes of neonatal mortality worldwide. Surviving preterm and asphyxiated newborns can develop neurological sequelae; therefore, timely and appropriate neonatal resuscitation is important to decrease neonatal mortality and disability rates. There are very few systematic studies on neonatal resuscitation in China, and its prognosis remains unclear. We established an online registry for neonatal resuscitation in Shenzhen based on Utstein’s model and designed a prospective, multicentre, open, observational cohort study to address many of the limitations of existing studies. The aim of this study is to explore the implementation and management, risk factors and outcomes of neonatal resuscitation in Shenzhen.

Methods and analysis
This prospective, multicentre, open, observational cohort study will be conducted between January 2024 and December 2026 and will include >1500 newborns resuscitated at birth by positive pressure ventilation at five hospitals in Shenzhen, located in the south-central coastal area of Guangdong province, China. Maternal and infant information, resuscitation information, hospitalisation information and follow-up information will be collected. Maternal and infant information, resuscitation information and hospitalisation information will be collected from the clinical records of the patients. Follow-up information will include the results of follow-up examinations and outcomes, which will be recorded using the WeChat applet ‘Resuscitation Follow-up’. These data will be provided by the neonatal guardians through the applet on their mobile phones. This study will provide a more comprehensive understanding of the implementation and management, risk factors and outcomes of neonatal resuscitation in Shenzhen; the findings will ultimately contribute to the reduction of neonatal mortality and disability rates in Shenzhen.

Ethics and dissemination
Our protocol has been approved by the Medical Ethics Committee of Shenzhen Luohu People’s Hospital (2023-LHQRMYY-KYLL-048). We will present the study results at academic conferences and peer-reviewed paediatrics journals.

Trial registration number
ChiCTR2300077368.

Leggi
Giugno 2024

Impact of physiotherapy access on health-related quality of life following hip fracture: an observational study on 30 752 hip fractures from the Norwegian Hip Fracture Register 2014-2018

Objectives
The main objective of this study was to investigate the characteristics of patients receiving private community physiotherapy (PT) the first year after a hip fracture. Second, to determine whether utilisation of PT could improve health-related quality of life (HRQoL).

Methods
In an observational cohort study, 30 752 hip fractures from the Norwegian Hip Fracture Register were linked with data from Statistics Norway and the Norwegian Control and Payment of Health Reimbursements Database. Association between covariates and utilisation of PT in the first year after fracture, the association between covariates and EQ-5D index score and the probability of experiencing ‘no problems’ in the five dimensions of the EQ-5D were assessed with multiple logistic regression models.

Results
Median age was 81 years, and 68.4% were females. Most patients with hip fracture (57.7%) were classified as American Society of Anesthesiologists classes 3–5, lived alone (52.4%), and had a low or medium level of education (85.7%). In the first year after injury, 10 838 of 30 752 patients with hip fracture (35.2%) received PT. Lower socioeconomic status (measured by income and level of education), male sex, increasing comorbidity, presence of cognitive impairment and increasing age led to a lower probability of receiving postoperative PT. Among those who used PT, EQ-5D index score was 0.061 points (p

Leggi
Giugno 2024

Evaluation of a novel university-based testing platform to increase access to SARS-CoV-2 testing during the COVID-19 pandemic in a cohort study

Objective
We aimed to evaluate the feasibility and utility of an unsupervised testing mechanism, in which participants pick up a swab kit, self-test (unsupervised) and return the kit to an on-campus drop box, as compared with supervised self-testing at staffed locations.

Design
University SARS-CoV-2 testing cohort.

Setting
Husky Coronavirus Testing provided voluntary SARS-CoV-2 testing at a university in Seattle, USA.

Outcome measures
We computed descriptive statistics to describe the characteristics of the study sample. Adjusted logistic regression implemented via generalised estimating equations was used to estimate the odds of a self-swab being conducted through unsupervised versus supervised testing mechanisms by participant characteristics, including year of study enrolment, pre-Omicron versus post-Omicron time period, age, sex, race, ethnicity, affiliation and symptom status.

Results
From September 2021 to July 2022, we received 92 499 supervised and 26 800 unsupervised self-swabs. Among swabs received by the laboratory, the overall error rate for supervised versus unsupervised swabs was 0.3% vs 4%, although this declined to 2% for unsupervised swabs by the spring of the academic year. Results were returned for 92 407 supervised (5% positive) and 25 836 unsupervised (4%) swabs from 26 359 participants. The majority were students (79%), 61% were female and most identified as white (49%) or Asian (34%). The use of unsupervised testing increased during the Omicron wave when testing demand was high and stayed constant in spring 2022 even when testing demand fell. We estimated the odds of using unsupervised versus supervised testing to be significantly greater among those

Leggi
Giugno 2024

An exploratory open-label multicentre phase I/II trial evaluating the safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe osteogenesis imperfecta in infants and fetuses: the BOOSTB4 trial protocol

Introduction
Severe osteogenesis imperfecta (OI) is a debilitating disease with no cure or sufficiently effective treatment. Mesenchymal stem cells (MSCs) have good safety profile, show promising effects and can form bone. The Boost Brittle Bones Before Birth (BOOSTB4) trial evaluates administration of allogeneic expanded human first trimester fetal liver MSCs (BOOST cells) for OI type 3 or severe type 4.

Methods and analysis
BOOSTB4 is an exploratory, open-label, multiple dose, phase I/II clinical trial evaluating safety and efficacy of postnatal (n=15) or prenatal and postnatal (n=3, originally n=15) administration of BOOST cells for the treatment of severe OI compared with a combination of historical (1–5/subject) and untreated prospective controls (≤30). Infants

Leggi
Giugno 2024

Experiences and perceptions of critical care nurses on the use of point-of-care ultrasound (POCUS) to establish peripheral venous access in patients with difficult intravenous access: a qualitative study

Objectives
This study aims to explore and describe critical care nurses’ (CCNs’) experiences and perceptions of using point-of-care ultrasound (POCUS) to establish peripheral intravenous access in patients with difficult intravenous access (DIVA).

Design
A qualitative design with a hermeneutic approach was chosen for this study. From May to August 2022, data were collected using individual, face-to-face, and digital semistructured interviews and analysed using Braun and Clarke’s reflexive thematic analysis.

Setting
The study were conducted in six intensive care units in both Norway and Sweden.

Participants
Nine CCNs experienced in using point-of-care ultrasound (POCUS) to establish peripheral intravenous access in patients with DIVA were recruited.

Results
Data analysis led to the construction of the overarching theme: ‘POCUS simplifies a complicated procedure’ based on the following five subthemes: ‘Sharing the experience’, ‘Seeing inside the body’, ‘Independent in establishing difficult intravenous access’, ‘Using POCUS to increase action readiness’, and ‘Appreciating an expanded role as critical care nurses’.

Conclusion
Ultrasound-guided peripheral intravenous access can become a valuable skill for CCN’s caring for patients with DIVA in the intensive care unit. This practice can potentially reduce patient suffering, improve patient outcomes, enable the CCN to provide high-quality care, improve action readiness, time management and job satisfaction for the nurses.

Leggi
Giugno 2024

Antibiotic prescribing practice using WHO Access, Watch and Reserve classification and its determinants among outpatient prescriptions dispensed to elderly population in six community chain pharmacies in Asmara, Eritrea: a cross-sectional study

Objective
To assess antibiotic prescribing practice and its determinants among outpatient prescriptions dispensed to the elderly population.

Design
A prescription-based, cross-sectional study.

Setting
Six community chain pharmacies in Asmara, Eritrea.

Participants
All outpatient prescriptions dispensed to the elderly population (aged 65 and above) in the six community chain pharmacies in Asmara, Eritrea.

Data collection and analysis
Data were collected retrospectively, between 16 June 2023 and 16 July 2023. Antibiotic prescribing practice was assessed using the 2023 World Health Organization (WHO) Access, Watch and Reserve (AWaRe) classification system. Descriptive statistics and logistic regression were performed using IBM SPSS (V.26.0). P values less than 0.05 were considered as significant.

Results
Of the 2680 outpatient prescriptions dispensed to elderly population, 35.8% (95% CI: 34.0, 37.6) contained at least one antibiotic. Moreover, a total of 1061 antibiotics were prescribed to the elderly population. The most commonly prescribed antibiotics were ciprofloxacin (n=322, 30.3%) and amoxicillin/clavulanic acid (n=145, 13.7%). The Access category accounted for the majority of antibiotics (53.7%) with 32.1% from the Watch category. Prescriber qualification (Adjusted Odds Ratio (AOR)= 0.60, 95% CI: 0.44, 0.81) and polypharmacy (AOR= 2.32, 95% CI: 1.26, 4.27) were significant determinants of antibiotic prescribing in the elderly population. Besides, sex (AOR=0.74, 95% CI: 0.56, 0.98), prescriber qualification (AOR=0.49, 95% CI: 0.30 to0.81) and level of health facility (AOR 0.52, 95% CI 0.34 to 0.81) were significant determinants of a Watch antibiotic prescription.

Conclusion
Antibiotics were prescribed to a considerable number of the elderly population, with more than half of them falling into the Access category. Further efforts by policy-makers are needed to promote the use of Access antibiotics while reducing the use of Watch antibiotics to mitigate risks associated with antimicrobial resistance.

Leggi
Giugno 2024