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Single catheter strategy for transradial angiography and primary percutaneous coronary intervention enhances procedural efficiency, microvascular outcomes, and cost-effectiveness: Implications for STEMI healthcare in resource-limited settings

by Mohajit Arneja, Swetharajan Gunasekar, Dharaneswari Hari Narayanan, Joshma Joseph, Harilalith Kovvuri, Sharath Shanmugam, Pavitraa Saravana Kumar, Asuwin Anandaram, Vinod Kumar Balakrishnan, Jayanty Venkata Balasubramaniyan, Sadhanandham Shanmugasundaram, Sankaran Ramesh, Nagendra Boopathy Senguttuvan

Background

Faster time to reperfusion can be achieved by minimizing various patient and system-level delays that contribute to total ischemic time. Procedural delays within the catheterization laboratory represent a non-negligible and modifiable component in the chain of reperfusion, but remain unquantified by conventional metrics such as door-to-ballon (D2B) time. Universal catheter approaches have rapidly gained traction as an alternative to the traditional two catheter approach for transradial coronary interventions. However, their utility for both diagnostic angiography and subsequent angioplasty is limited, and the impact of this strategy on reperfusion outcomes has remained unexplored. We utilized a procedural metric termed fluoroscopy-to-device (FluTD) time to quantify the efficiency of a single catheter strategy, and assessed its impact on epicardial and myocardial perfusion.

Methods and results

In this retrospective study, consecutive STEMI patients undergoing transradial primary PCI (pPCI) at a tertiary care center in India between May 2022 to October 2024 were analyzed. Patients were divided into two groups: 51 underwent PCI using a single universal guiding catheter (UGC), and 51 underwent the conventional two-catheter (CTC) approach. The primary outcome of the study was a comparison of the FluTD time between the two procedural strategies. Secondary outcomes included myocardial blush grade (MBG), Thrombolysis in Myocardial Infarction (TIMI) flow grade, total fluoroscopy time, radiation dose, device safety and efficacy, and procedural success.The median FluTD time was significantly shorter in the UGC compared to the CTC group (3 minutes [IQR 3–4] vs. 10 minutes [IQR 8–17], p  Conclusion

A single catheter strategy for both angiography and pPCI in STEMI patients was associated with a significant reduction in FluTD time and improved microvascular perfusion, without compromising device safety or efficacy. In low- and middle-income countries (LMICs), where intra- and extra-procedural delays are often more pronounced, inclusion of the single catheter strategy can optimize catheterization workflows and yield substantial cost-savings.

The Green Maternity project: A midwife‐led initiative to promote correct waste segregation on an Australian postnatal ward

Abstract

Aims

Healthcare waste production is a significant contributor to carbon emissions, negatively impacting the environment. Ineffective healthcare waste disposal results in greater measures to manage it which is costly to both the environment and healthcare organizations. This study aimed to improve waste management in a tertiary maternity hospital. Specifically, the impact of a midwife-led intervention to improve waste segregation, staff knowledge and attitudes and waste management-related costs was investigated.

Design

A multi-method study including pre- and post-intervention staff waste management knowledge and attitude surveys and waste audits of bins located on the postnatal ward.

Methods

The intervention included education sessions, posters and signage by waste bins and monthly newsletters distributed throughout 2021 to raise staff awareness of correct waste segregation processes. Pre- and post-intervention surveys were distributed in early 2021 and early 2022, respectively. The waste audits occurred on three occasions, January, July and December of 2021. The waste audit included total waste in kilograms (kg), waste in kg by segregation and identification of correct and incorrect segregation. Waste audit and quantitative staff survey data were analysed using descriptive statistics and chi square. Qualitative data from the staff surveys were analysed using content analysis.

Results

Knowledge and attitudes to waste management were similar across pre- and post-intervention staff surveys. Knowledge of accurate allocation of specific items to waste streams was variable with errors identified in both the pre- and post-surveys. Waste audit data showed reductions in clinical waste at each measurement, with a 71.2% decrease in clinical waste from baseline to the final audit. Accuracy of waste segregation also improved from the baseline to final audit, resulting in a 48% reduction in waste management costs.

Conclusion

The midwife-led initiative improved waste segregation and achieved the associated waste management cost reduction.

Impact

A midwifery-led initiative to address waste production and segregation on a maternity ward had a positive impact on waste segregation practices and associated waste management costs. The existence of change champions along with in-service sessions, posters and newsletters to raise awareness of correct waste segregation resulted in a 71% reduction of incorrect items being placed in clinical waste bins. Challenges such as COVID-19 pressures and workload made it difficult for midwives to engage in waste management education and effective waste segregation.

Patient or Public Contribution

No patient or public contribution.

What Does this Paper Contribute to the Wider Global Clinical Community?

Implementing clinician-led waste management interventions across hospital wards while addressing workload issues are likely to have significant cost benefits for organisations and minimise the environmental impacts of healthcare settings.

Efficacy of a novel sensory discrimination training device for the management of phantom limb pain: protocol for a randomised placebo-controlled trial

Por: Oatway · S. · Martin · D. · Graham · A. · Batterham · A. · MacSween · A. · Smith · S. · Ravindran · D. · Ryan · C.
Introduction

Many amputees experience phantom limb pain (PLP). Pharmacological management is the mainstay of treatment, but effectiveness is limited, and it is associated with significant side effects. Sensory discrimination training (SDT) is a non-pharmacological treatment for PLP. Previously, SDT required a clinician, or carer, to administer it, creating a barrier to real world use. In this trial, an automated SDT device (SP1X, 2pd Ltd, Middlesbrough, United Kingdom) for the self-management of PLP will be investigated for efficacy.

Methods and analysis

The Phantom Relief is a decentralised, randomised, placebo-controlled, mixed-methods, superiority trial. Participants will take part from their own homes, using an electronic data capture tool to complete all trial documentation. Eligible, consenting individuals with PLP (intensity rated as ≥4 on a 0–10 scale; n=100) will be randomised to receive the SP1X device (intervention group) or a placebo device SP1X7 (placebo group). The first and second treatment sessions will be observed via video call to provide set-up guidance and any additional advice needed. The primary outcome measure will be the McGill Pain Questionnaire revised (SF-MPQ-2). Outcome measures will be collected at baseline, 3 weeks (immediately post intervention) and 3 months follow-up. Statistical analysis will be carried out by a blinded statistician (analysis of covariance model conditioning on the baseline and stratification factors). Semi-structured interviews will be carried out with a sub-sample (n=10–15) of intervention group participants. Participants will be provided with their allocated device for home use. Online video calls will be used to instruct participants on how to set up and use the device by the research assistant (RA). The RA will observe the first and second treatment sessions and provide any additional advice needed. Participants in both groups will be asked to use the device for 60 min/day for at least 15 days of the 21-day treatment period and to record device use in a study diary.

Ethics and dissemination

Approval has been obtained from Teesside University School of Health and Life Sciences Research and Ethics Committee, the North of Scotland Research Ethics Service, Health Research Authority, and a letter of no objection was obtained from the Medicines and Healthcare products Regulatory Authority. The results will be disseminated through peer-reviewed articles, conference presentations and a doctoral thesis.

Trial registration number

NCT04103983.

Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

Abstract

Aim

Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.

Background

Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.

Design

This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.

Conclusion

The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.

Relevance to workforce development

This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.

Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America

Por: Balmert Bonner · L. · Janicki · J. · Georgiadis · A. · Truong · W. · Harris Beauvais · D. · Belthur · M. · Daley · E. L. · Franzone · J. · Howard · A. · May · C. · Rockhold · F. · Schulz · J. · Bailey · M. · Chiswell · K. · DeLaRosa · J. · Brooks · J. T. · Cantanzano · A. A. · Chan · A.
Introduction

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Methods and analysis

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethics and dissemination

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

Trial registration number

NCT05131685.

Prevention and Early Delirium Identification Carer Toolkit (PREDICT): A Study Protocol for a Stepped‐Wedge, Cluster Randomised Controlled Trial

ABSTRACT

Background

Delirium, a common, serious and often preventable complication in older hospitalised adults, contributes to significant health and social care costs. Carers are uniquely positioned to identify early signs and support delirium prevention. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT), a novel model of care designed to educate carers about delirium management and prevention strategies, enables them to actively participate in the care and recovery of their person. Developed through a comprehensive literature review, a co-designed eDelphi and pilot study, PREDICT demonstrated acceptability and feasibility.

Aims

To evaluate the effectiveness, implementation and cost-benefit of a PREDICT in hospital settings.

Method

A stepped-wedge cluster randomised controlled trial (SW-cRCT), consisting of a cohort study, healthcare service evaluation, and process evaluation. The study will assess carer and staff knowledge of delirium, carer care giving stress, health service outcomes (e.g., incidence, length of stay, readmissions) and cost-benefit.

Discussion

PREDICT is a scalable, person-centred approach that supports both patients and carers, with the potential to embed best-practice delirium management into routine healthcare.

Public and Patient Involvement

This study was developed in consultation with older adults, carers and healthcare staff. Two consumer representatives joined the project steering committee and contributed to shaping the research question, refining the study protocol and selecting outcome measures relevant to families and healthcare staff. Carers were involved in reviewing participant information sheets and the PREDICT website, providing feedback to ensure clarity and accessibility. Results will be shared with participants and the wider community through plain-language summaries and public presentations.

Trial Registration

Australian and New Zealand Clinical trial: ACTRN12625000705482 registered on the 3rd of July 2025

Interpreting Context in Rural and Remote Aged Care Facilities in Readiness for a New Care Model: A Mixed Method Study

ABSTRACT

Background

Geographical isolation compounds limited access to healthcare services and skilled workforce for the provision of rural aged care. Residents have complex chronic disease management and end-of-life care needs. An undersupply of general medical practitioners due to retirement, attrition or unfilled training places in Australia has impacted recruitment to rural areas. Nurse practitioners have been identified as a potential solution.

Aim

To describe and explore the inner (local and organisational) and outer (wider health system) contexts of healthcare, from the perspective of care staff and residents' families. This, in turn, aims to inform the planned implementation of a nurse practitioner model, in several aged care facilities, operating within rural and remote settings, in Queensland Australia.

Design

A convergent mixed methods design.

Methods

Qualitative data were collected, in 2022–2023, using semistructured interviews with staff focusing on role, knowledge development, workplace culture and care relationships with local community. Resident's family's perspectives were obtained as a secondary analysis of organisational feedback data. Quantitative data were collected from direct care workers using the Alberta Context Tool for Long-Term Care. Data were analysed according to type and integrated.

Results

Relational care for residents and families is highly valued but provision of quality is challenging where time-poor staff are perceived to be doing the best they can. Scarce local healthcare services make it difficult to meet resident healthcare needs. Despite the supportive organisational culture, evolving policy requirements have impacted already difficult staff recruitment in rural settings.

Conclusion

Identifying contextual needs of organisations in readiness for change highlights geographical and sectoral nuances influencing any future implementation. As government policy changes to improve the older adult care sector, rural and remote facilities are forced to increasingly adapt.

Implications for the Profession

Context-specific needs extend far beyond a nurse practitioner providing additional expertise in care provision.

Impact Statements

What problem did the study address? Nurse practitioners have been successfully implemented into residential aged care facilities in metropolitan and major regional centres but translating this role into rural and remote Australia requires being cognisant of the needs, unique challenges and context of this setting.

What were the main findings? In an organisational culture of support, the importance of staff providing relational care and having connection with older adult residents and families was a central driver. It was challenging for staff to meet complex care requirements in the absence of local healthcare options and support. Time pressures, from inadequate staffing and changing structural aged care sector, force the prioritising of care requirements.

Where and on whom will the research have an impact? Older adults, policy makers and aged care providers will benefit from understanding the context of rural and remote settings, particularly in identifying potential solutions when there are gaps in primary and secondary healthcare.

Reporting Method

The GRAMMS checklist was followed in reporting of this study.

Patient or Public Contribution

Two lived experience consumers were involved as research team members. One was involved during the development and submission of the funding application and another during project activities including data collection and analysis and the development of publications.

Economic evaluation of a person-centred care intervention with a digital platform and structured telephone support for people with chronic heart failure and/or chronic obstructive pulmonary disease: results from a randomised controlled trial in Sweden

Por: Harvey · B. P. · Barenfeld · E. · Fors · A. · Ekman · I. · Swedberg · K. · Gyllensten · H.
Objectives

The aim of the study was to evaluate the healthcare costs and effects of a remote person-centred care (PCC) add-on intervention compared with usual care for people with chronic heart failure (CHF) and/or chronic obstructive pulmonary Disease (COPD) from a societal perspective.

Design

A cost-effectiveness analysis (CEA) based on the results from a randomised controlled trial.

Setting

The study was conducted from August 2017 until June 2021 within nine primary care centres across Western Sweden.

Participants

Participants in the study had a diagnosis of COPD (J43.0, J44.0–J44.9) and/or CHF (I50.0–I50.9).

224 patients were randomly allocated to the study groups. After two withdrawals, the final intention-to-treat analysis included 110 participants in the intervention group and 112 in the control group.

Interventions

Both the intervention and control group received usual care through their primary care centres. In addition, the intervention group participated in a remote PCC add-on intervention consisting of a digital platform and structured telephone support.

Primary outcome

Incremental cost-effectiveness ratio using direct healthcare costs, productivity loss and prescription drug costs, compared with health effects measured using the EuroQoL questionnaire (EQ-5D-3L) over a 2-year time horizon.

Results

The intervention group had lower healthcare utilisation in inpatient care, specialised outpatient care and reduced productivity loss. The CEA showed incremental effects of 0.0469 quality-adjusted life years and incremental costs of SEK –68 533 (Swedish crowns). The PCC alternative was both more effective and resulted in lower healthcare costs compared with usual care, that is, PCC was dominant.

Conclusions

The results of this CEA demonstrated that a remote PCC add-on intervention for people with COPD and/or CHF had lower healthcare costs and higher health-related quality of life compared with usual care.

Trial registration number

NCT03183817 ClinicalTrials.gov.

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study

Por: Jiwa · A. · Cameron · M. M. · Ademuyiwa · A. O. · Adisa · A. · Aguilera Arevalo · M. L. · Bahrami Hessari · M. · Bhangu · A. · Brennan · P. M. · Clark · N. · Cresswell · K. · Czerwinska · I. · DAdderio · L. · Gunn · E. · Haque · P. D. · Ikegwuonu · T. · Lawani · I. · Morton · D. · Nganwa
Introduction

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

Methods and analysis

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Ethics and dissemination

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

Trial registration number

NCT06565559.

Association between prenatal Zika virus exposure and neurodevelopmental outcomes in offspring: a protocol for a systematic review and meta-analysis of observational studies

Por: Nagata · A. · Swe · T. M. · Iwabuchi · T. · Haque · M. · Razia · S. · Tsuchiya · K. J. · Senju · A. · Rahman · M. S.
Introduction

Zika virus (ZIKV) infection during pregnancy has been associated with adverse birth outcomes, including congenital Zika syndrome, characterised by features such as microcephaly. However, the broader neurodevelopmental influence of prenatal ZIKV exposure, especially among offspring without congenital anomalies at birth, remains poorly understood. While previous studies, including a review, have explored neurodevelopment in ZIKV-exposed children, comparative pooled estimates between exposed and unexposed groups remain scarce. This systematic review and meta-analysis aims to evaluate the association between prenatal ZIKV exposure and neurodevelopmental outcomes in offspring without congenital anomalies at birth, using data from observational studies with defined control groups.

Methods and analysis

We will systematically search multiple databases, including PubMed, EMBASE, Scopus, CINAHL, PsycINFO, Cochrane Library and Web of Science, alongside grey literature sources such as Google Scholar and conference proceedings. Eligible studies will include observational designs (cohort and case-control) comparing neurodevelopmental outcomes between children with and without prenatal ZIKV exposure. Primary outcomes will include gross motor, fine motor, communication, problem-solving, social-emotional and cognitive development assessed with validated tools. Three reviewers will independently screen studies, extract data and assess methodological quality using the Newcastle-Ottawa Scale and the Grading of Recommendations, Assessment, Development and Evaluation approach. A meta-analysis will be conducted where appropriate, with heterogeneity assessed using the I² statistic and further explored through subgroup and meta-regression analyses.

Ethics and dissemination

Ethical approval is not required, as the study involves secondary analysis of publicly available data. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD420251011184.

How can citizen science enhance mental health research quality: theory of change development

Por: Todowede · O. · Rennick-Egglestone · S. · Boyd · D. · Moran · S. · Bell · A. · Sweeney · A. · Hart · A. · Tomlin · A. · Robotham · D. · Repper · J. · Rimmer · K. · Brown · M. · Howells · M. · Singh · S. · Lavis · P. · Higton · F. · Hendy · C. · Slade · M.
Objective

Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.

Design

Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)

Methods

We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.

Results

A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.

Conclusion

The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.

Pragmatic trial evaluating a randomly allocated Supplemental Nutrition Assistance Program outreach and enrolment assistance programme in Michigan: study protocol

Por: Samuel · L. · Stuart · E. A. · Liu · Y. · Szanton · S. L. · Clark · A. L. · Miguel · M. · Schneider · M. · Mashrah · A. · Laretz · M. · Swenor · B.
Introduction

Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.

Methods and analysis

The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.

Ethics and dissemination

The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.

Consensus on addressing HIV-related stigma and achieving the societal enabler targets using an adapted Delphi process

Por: Molesworth · K. · Nkosi · S. · Camacho · S. · Caswell · G. · Salem · S. · Baral · S. · Kamarulzaman · A. · Sprague · L. · Stackpool-Moore · L.
Objectives

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.

Design

An adapted Delphi consensus-building process using two rounds of online questionnaires.

Setting

Online questionnaires sent to a global expert panel.

Participants

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.

Results

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.

Conclusions

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.

Developing service models for adult palliative and end of life care for people with a learning disability (The DAPPLE Project): protocol for a mixed-method study

Por: Tuffrey-Wijne · I. · Tilley · E. · Tyler · F. · Islam · Z. · Borgstrom · E. · Jordan · J. · Glover · G. · Wallace · L. · Roberts · C. · Giles · J. · Keagan-Bull · R. · Cresswell · A. · Anderson-Kittow · R.
Introduction

People with a learning disability face significant health and mortality inequalities as well as wider systemic inequities. Challenges in palliative and end of life care (PEOLC) include communication difficulties, lack of involvement in decision-making and multimorbidity. Early identification of PEOLC needs is challenging, impacting timely care planning. The study aims to (1) understand barriers and enablers to providing high-quality, accessible PEOLC for people with a learning disability, and identify effective service delivery models and interventions and (2) improve PEOLC quality and accessibility by developing robust guidance for health and social care services.

Methods and analysis

This is a mixed-methods study guided by the NHS England 2021 Ambitions Framework and adopting the Social Model of Disability. There are four workstreams: (1) a retrospective cohort analysis of the Clinical Practice Research Datalink; (2) a rapid scoping review; (3) field work in four study sites across England, involving (a) interviews with senior leaders and commissioners (n=up to 16) and informal stakeholder engagement conversations; (b) ethnographic case studies with people with a learning disability at the end of life (n=up to 20) and retrospective case reviews of people with a learning disability who have died (n=up to 40), using family and staff interviews and (c) development and piloting of methods for enabling systematic identification of PEOLC need, using experience-based co-design and (4) patient and public involvement (PPI) activities and a co-production group of 10 people with a learning disability to support data analysis and outputs. Data will be analysed using adapted framework analysis methodology. This is an inclusive, co-produced study with significant involvement of advisors and researchers with a learning disability as part of the study team.

Ethics and dissemination

Ethical approval has been obtained for workstreams 1, 3a and 3b. Significant attention has been paid to ensuring informed consent, making adjustments for capacity. Accessible information and consent forms will be used, involving consultees and adhering to the Mental Capacity Act for participants who lack capacity. Data security will follow General Data Protection Regulation rules. Dissemination will include patient exemplars, guidance and various resources, engaging stakeholders through multiple formats.

Study registration

researchregistry10500.

Surgery or radiotherapy for early-stage cancer study (SORT) target trial protocol: stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for early-stage non-small cell lung cancer (NSCLC)

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Hutchings · A. · Aggarwal · A. · ONeill · S. · Rachet · B. · Edwards · J. · Faivre-Finn · C. · Grieve · R. · Surgery or Radiotherapy Study (SORT) group · Choudhury · Vohra · Cresswell · Charlton · Chuter · Nolte · Gravenhorst · Alencar · Mon
Introduction

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

Methods and analysis

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethics and dissemination

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

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