Conectar
Growing evidence suggests that vaccines targeting respiratory pathogens have non-specific and broader effects. We aimed to investigate the non-specific effects of respiratory vaccines on acute lower respiratory infection (ALRI) hospitalisations and associated outcomes in children
Systematic review and meta-analysis.
We searched online databases including Medline, Embase, CINAHL, Scopus and Clinical Trials.gov from inception to 24 January 2024.
We included human studies involving non-specific/off-target effects of respiratory vaccines (including maternal, infant and childhood vaccines) and excluded studies investigating the Bacille Calmette-Guérin vaccine and non-pathogen-confirmed outcomes following pneumococcal conjugate vaccination (PCV).
We used Research Screener, a machine learning tool, to semi-automate the abstract screening process and Covidence, a management and streamlining software for full-text reviews and data extraction. A meta-analysis was conducted if four or more studies reported on the same outcome and the same exposure vaccine.
After removing duplicates, 9727 articles were identified. After screening and full-text reviews, 20 articles were eligible. Of those, four met the requirements for a meta-analysis which showed a 21% vaccine effectiveness (VE) (95% CI 8.0% to 32.0%) of maternal influenza vaccine against all-cause ALRI hospitalisations in infants
Our review demonstrated both protective and neutral non-specific effects of respiratory vaccines against ALRI-hospitalisations and related outcomes in young children. Such effects should be considered as part of the full value of a vaccine and how vaccine investments are prioritised. Further research on the impact of respiratory vaccines on antibiotic prescribing rates is essential as consistent reductions may help contribute to reducing the global burden of antimicrobial resistance.
CRD 42023476038.
Outcome measures used in sciatica research lack standardisation, making it difficult to combine data for analysis. This scoping review identified and categorised Patient Reported Outcome Measures (PROMs) employed in randomised controlled trials investigating sciatica interventions, providing a foundation for developing a consensus-based core outcome set.
Scoping review.
A systematic search was conducted across MEDLINE, Embase and Cochrane Central for research published between 1999 and 2024.
We included randomised controlled trials that involved patients with sciatica and used at least one PROM.
Screening and data extraction were performed independently by at least two reviewers. PROMs were categorised using the OMERACT Filter 2.0 framework, inductively sub-categorised into domains, and then the frequency was counted to identify patterns of use. Collection time points and intervention type were also assessed.
187 studies met the inclusion criteria. These studies employed 69 different PROMs, collected 548 times across all papers. The Visual Analogue Scale for pain (n=115), Oswestry Disability Index (n=109) and Numeric Pain Rating Scale (n=74) were most frequently used. PROMs predominantly addressed the pathophysiological (n=274) and life impact (n=262) domains, with minimal attention to resource use/economic impact (n=12). Injection-based interventions were the most studied treatment approach. Follow-up periods using the same PROMs varied considerably between studies, with trends by intervention type.
This review identified and categorised PROMs from numerous research studies, revealing substantial heterogeneity in outcome measurement for sciatica trials. This demonstrates the need for a standardised core outcome set. The predominance of use of non-sciatica-specific pain and disability measures suggests potential gaps in capturing sciatica-specific outcomes. Inconsistent follow-up durations and administration methods further highlight the requirement for standardisation.
Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.
A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.
Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.
37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).
Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.
This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.
Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.
This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.
The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.
The WHO Surgical Safety Checklist (SSC) can improve patient outcomes through checks and enhancing the safety climate, provided the team engage. Patients are central to that team and may be awake during part or all of many procedures. Their greater inclusion in the SSC process could enhance its checking objectives by using patient knowledge of details relevant to proposed procedures, and its objective of improving culture by emphasising patient identity, seeing patients as individuals rather than items on a production line. We aimed to evaluate SSC use, including clinicians’ and patients’ perspectives, in cardiothoracic operating rooms (CTORs) and cardiac catheterisation laboratories (CCLs), and to identify opportunities to refine its use in these spaces.
We undertook a multimethod study based on positivism and interpretivism, with evaluation of SSC administration and interviews. We evaluated SSC administration during 20 Sign Ins, 20 Time Outs and 20 Sign Outs in CTORs and 20 Time Outs in CCLs (11 coronary angiography and 9 electrophysiology cases) using the WHO Behaviourally Anchored Rating Scale (WHOBARS, 1–7, where higher scores indicate better practice). We additionally interviewed 10 clinicians and 17 patients about their experiences and perceptions of safety and SSC use. We undertook thematic analysis of interview data.
CTORs and CCLs in an Auckland public hospital.
We observed 171 clinicians during 20 cases. We interviewed 10 clinicians (Pakeha/New Zealand/European n=6; male n=5; doctor n=5). We interviewed 17 patients (Pakeha/New Zealand/European n=12; male n=10; age range 45–81 years).
In CTORs, the SSC was used in full: median (IQR) WHOBARS score was 5.9 (5.2, 6.5). In CCLs, its use differed between electrophysiology and angiography CCLs: median (IQR) WHOBARS score was 4.50 (3.2, 5.6). In both CTORs and CCLs, high levels of carefulness and respect between team members were observed. Clinicians described the SSC as valuable and identified context-related reasons for variations in its use. Patients wanted to feel cared for and respected (including culturally). The SSC contributed positively to this. Clinicians expressed reservations about increasing patients’ involvement with the SSC. However, patients’ comments supported their increased engagement in the SSC process (including establishing their preferred names).
The SSC is used at Auckland City Hospital with some variation between services and with high levels of carefulness and respect. The SSC increased patients’ sense of being cared for. With modification (eg, by verifying their preferred name during the Sign In phase), the SSC could enhance patients’ perception of being seen as individuals, their cultural safety and the safety climate in operating and procedure rooms, and hence potentially improve patient outcomes. Our findings reinforce the value of regular evaluation and context-relevant modification of SSC for its effective use.
Food insecurity is increasing in the UK, impacting choice and diet quality. The current means-tested free school meals (FSM) policy was put in place to address dietary inequalities and food insecurity in school children. In secondary schools, approximately 20% of students who are eligible and registered do not take their FSM. Working across a range of schools that have variable levels of FSM uptake, this study aims to evaluate the effectiveness and cost-effectiveness of the current means-tested FSM policy in UK secondary schools on diet and food insecurity outcomes, understand what factors are associated with uptake and test the potential impact of any proposed policy change.
Secondary schools (n=32) in both Northern Ireland and the Midlands region of the UK are being recruited into the study. Data will be collected from school staff, governors, students and parents via questionnaires, as well as observational data of school eating environments. Qualitative data will be collected in selected case study schools (n=6–8). Multilevel modelling will be undertaken to evaluate the association between FSM uptake and fruit and vegetable intake, overall diet quality and food insecurity in all students. Economic evaluation will be conducted using a cost–utility approach. The effect of policy change will be modelled and school factors associated with FSM uptake explored using multiple methods.
Ethical approval has been obtained from Queen’s University Belfast Faculty of Medicine, Health and Life Sciences Research Ethical Committee (MHLS 23_55). Findings will be disseminated to key national and local agencies, to schools through reports and presentations, and to the public through media and open access publications.
Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.
The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.
Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.
Commentary on: Sushko K, Strachan P, Butt M, Nerenberg K, Sherifali D. Supporting self-management in women with pre-existing diabetes in pregnancy: a mixed-methods sequential comparative case study. BMC nursing. 2024 Jan 2;23(1):1.
Implications for practice and research Policies are required to support self-management of diabetes during labour and delivery in practice. Future research should focus on developing and implementing interventions to support self-management of diabetes during labour and delivery.
Sushko et al
To explore how urinary (UI) and anal incontinence (AI) affect various aspects of quality of life (QoL) and the risk of depression 6 months postpartum, using patient-reported outcome measures (PROMs).
Prospective cohort study.
Women who gave birth between 2020 and 2022 within a local obstetric collaborative network in the Netherlands, including 13 midwifery practices, 5 maternity care organisations at the primary care level, and 1 secondary teaching hospital.
Prospectively collecting data by using the questionnaires of the International Consortium for Health Outcome Measures Pregnancy and Childbirth set at five moments during pregnancy and postpartum.
Associations between UI, AI, QoL and likelihood of depression based on PROMs collected from questionnaire 6 months postpartum.
Of the 663 women who completed the 6-month postpartum questionnaire, 79 women had severe UI, 71 had severe AI and 45 experienced both. These women reported significantly lower QoL as measured by PROMIS-10: 34 (IQR 30.5–38.5), 34 (IQR 30–39.5), and 32 (IQR 27–35), respectively, compared with a score of 37 (IQR 33–42) for the total population. Additionally, the positive rate for depression screening was notably higher among these groups, with rates of 6%, 10% and 18%, respectively, compared with 3% for the overall group.
In this observational cohort study, we found that severe UI and/or AI 6 months postpartum significantly impact QoL and increase the likelihood of depression, as indicated by PROMs. Our findings emphasise the importance of screening, evaluation and treatment of UI and/or AI to improve the QoL and reduce the risk of depressive disorders for postpartum women.
Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.
A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.
Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.
Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.
A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p
This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.
To examine health and social service use pre- and post-cochlear implant in adults.
A retrospective cohort study.
All public and private hospitals in Australia.
A total of 3033 adults aged ≥18 years who received a cochlear implant in Australia between 1 January 2014 and 31 December 2018 were included. Participants were followed for 3 years pre-implant date and 3 years post-implant date or until death. Data were sourced from the Person Level Integrated Data Asset.
The study examined the (i) number of visits to general practitioners (GPs), specialists and audiologists; (ii) fee charged, benefit paid and out-of-pocket (OOP) expenses for health services; (iii) personal income; (iv) completion of higher education and post-high school vocational education and training and (v) number of government benefits and concession cards received.
The mean age of adults at cochlear implantation was 63.3 years (SD 16.1). Over the 3 years period before and after implantation, the mean number of GP visits remained stable (24.5 pre-implant vs 24.7 post-implant), specialist visits decreased (6.4 pre-implant vs 5.3 post-implant) and audiologist visits increased (1.7 pre-implant vs 6.6 post-implant). Higher GP visit rates were observed both pre- and post-implantation among females (RR 1.13 vs 1.14), older adults (RR 1.06 vs 1.15), individuals needing assistance with daily activities (RR 1.11 vs 1.12), individuals with chronic health conditions (RR 1.25 vs 1.34), with ≥6 RxRisk comorbidities (RR 2.35 vs 2.22) and adults residing in socio-economically disadvantaged areas (RR 1.64 vs 1.19). Mental health conditions were associated with increased specialist visits pre- and post-implantation (RR 2.57 vs 2.53), while employed individuals had higher specialist visit rates post-implantation (RR 1.58). Average OOP costs for health services decreased by 31.4% post-implant. Government benefits were higher pre-implant (55.6%) than post-implant (44.4%). Females and adults needing assistance with activities of daily living were more likely to seek government benefits.
These findings highlight the need for tailored healthcare and social support services to address the diverse needs of cochlear implant users, ensuring comprehensive care and support throughout their healthcare journey.
The emergency department (ED) often serves as a crucial pathway for cancer diagnosis. However, little is known about the management of patients with new suspected cancer diagnoses in the ED. The objective of this study was to explore emergency physicians’ experiences in managing patients with a newly suspected cancer diagnosis in the ED.
Between January and April 2024, we conducted a qualitative descriptive study. Interviews were conducted by trained research personnel using a semistructured interview guide. Interviews were conducted until thematic saturation was achieved. The interview transcripts were coded and thematic analysis was used to uncover key themes.
Emergency physicians practising in Ontario, Canada.
20 emergency physicians were interviewed. Four themes around the management of patients with new suspected cancer diagnoses in the ED were identified: (1) healthcare system-level factors that impact suspected cancer diagnosis through the ED, (2) institutional and provider-level challenges associated with managing patients with a suspected cancer diagnosis in the ED, (3) patient-level characteristics and experiences of receiving a cancer diagnosis in the ED and (4) the need for care coordination for patients with suspected cancer in the ED.
Physicians experienced several unique challenges in managing patients with a suspected cancer diagnosis in the ED. Overall, the findings of this study suggest these challenges often make the ED a difficult environment in which to deliver a suspected cancer diagnosis.
To seek consensus among global experts on concepts, measures and approaches to guide national and global action to address HIV-related stigma and formulate a call to action. This outlines priorities to unite actors in more effectively responding to and resourcing efforts to address HIV-related stigma.
An adapted Delphi consensus-building process using two rounds of online questionnaires.
Online questionnaires sent to a global expert panel.
50 global experts on HIV-related stigma and discrimination representing sectors including civil society, people living with HIV and key populations, research and academia, clinical practice, law, non-profit organisations, the United Nations, and policy and donor organisations.
The panel reached consensus on 55 points relating to the 12 broad themes extracted from the evidence base. These comprised the importance of addressing HIV-related stigma at scale; HIV-related stigma terms and definitions; Frameworks; Programming and approaches; Community leadership in HIV-related stigma-reduction implementation; Intersectional stigma and discrimination; Stigma and discrimination measures and assessment scales; Monitoring and evaluation; Stakeholder and community participation in monitoring and evaluation; Knowledge gaps and research needs; Funding and Commitment calls. From these, a consensus statement and call to action were formulated on priorities for strong political and financial commitments by all countries to reduce and mitigate HIV-related stigma and achieve global HIV targets adopted in 2021.
This study illustrated that global experts across sectors consider that action is needed to support the three critical enablers of the HIV response—society, systems and services—to ensure that HIV services are non-discriminatory and person-centred. The importance of attention and action to reduce stigma is critical in the current geopolitical and funding crisis affecting HIV and global health.
Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.
The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.
Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.
The protocol is registered in Open Science Framework (https://osf.io/ua8z9).
Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.
DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.
Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.
Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.
This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.
There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend or partner of the patient) can help mitigate some of these patient-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence.
INVITE-Home (innovative administration of long-acting injectables for HIV treatment enhancement at home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.
This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV.
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
FreshRSS 