Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal

Introduction
Only 30%–50% of people referred to clinics during community-based eye screening are able to access care in Botswana, India, Kenya and Nepal. The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.

Methods and analysis
We will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. The aim is to identify serial marginal gains that cumulatively result in large improvements to equity and access. The primary outcome will be the probability of accessing treatment among the population group with the worst access at baseline. We will calculate Bayesian posterior probabilities of clinic attendance in each arm every 72 hours. Each RCT will continually recruit participants until the following default stopping rules have been met: >95% probability that one arm is best; >95% probability that the difference between the best arm and the arms remaining in the trial is

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Change in email address

In the Original Investigation titled “Cost Savings and Waste Reduction Through Redispensing Unused Oral Anticancer Drugs: the ROAD study” published online on November 16, 2023, in JAMA Oncology, the email address for the corresponding author, Elisabeth M. Smale, PharmD, has changed to e.smale@erasmusmc.nl. The article was updated online.

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JAMA Oncology

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

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Optimizing Care Planning for Older Adults in Primary Care

Advance care planning (ACP) is fundamentally a communication process involving patient, family, and clinician discussions about potential future care that ideally prepares individuals and their surrogates for the difficult decisions that may arise at the end of life. In JAMA Internal Medicine, Wolff et al present findings from a pragmatic randomized clinical trial (henceforth pragmatic trial) that investigates whether their multicomponent primary care–based intervention enhances ACP process and outcomes. They recruited 64 915 adults (including people with dementia) 65 years and older from 51 primary care practices within 2 mid-Atlantic health systems. Patients in the SHARING Choices (NCT04819191) intervention group received an introductory letter to ACP, an agenda-setting checklist for the patient and family, an advance directive with durable medical power of attorney and living will, access to a patient portal, and access to a grant-funded facilitator certified through the Respecting Choices ACP. Clinicians at the intervention sites also received education about dementia. Researchers evaluated new documentation of end-of-life preferences in the electronic health record (EHR) and potentially burdensome care at end-of-life as 2 primary outcomes. Newly documented ACP was observed in 12% of intervention participants vs 7% of controls with a significant treatment effect for the overall cohort; this effect was attenuated among participants identified in the EHR as Black race, 75 years or older, or having diagnosed dementia. Researchers also examined receipt of potentially burdensome care for the 1498 participants who died with serious illness within 18 months after study entry; surprisingly, rates were higher in the intervention (29%) vs control (21%) among people without dementia, but no treatment effects (intervention (20%) vs control (13%) were observed among people with dementia.

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Focusing on Systems and Policies to Solve the Kidney Transplant Equity Crisis

Minoritized individuals in the US experience both disproportionally high rates of kidney failure and low rates of kidney transplant. These disparities create an urgent health crisis, since kidney transplant is a superior treatment for kidney failure, resulting in a 30% to 70% lower risk of death and substantially improved quality of life compared to dialysis. Among transplant options, living donor kidney transplant (LDKT) offers superior outcomes. However, only 30% of all kidney transplants result from LDKT. Furthermore, profound inequities in LDKT for Black and other minoritized individuals have been present for decades. In 1995 to 1999, minoritized individuals were between 17% (Hispanic or Latino individuals) and 55% (Black individuals) less likely than White individuals to receive LDKT. Disparities have worsened over time such that in 2010 to 2014, minoritized individuals were between 48% (Hispanic or Latino individuals) and 73% (Black individuals) less likely to receive LDKT when compared to their White counterparts. These stark disparities are heavily influenced—but not entirely explained—by differences in individuals’ health care access and socioeconomic status. Adults older than 65 years are also less likely to receive LDKT compared to others, despite the fact that the median age at kidney failure is 64 years.

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A Values Proposition for Cancer Care

This Viewpoint discusses what a value proposition could look like in oncology and how it should reflect a clinician’s commitment to partner with patients to improve outcomes through individualized communication and shared decision-making centered on the patient’s values.

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Real-world outcomes in patients with melanoma brain metastasis: a US multisite retrospective chart review study of systemic treatments

Objective
This study examined real-world treatment patterns and outcomes in patients with melanoma brain metastasis (MBM) treated with first-line immunotherapy consisting of nivolumab plus ipilimumab or anti-programmed death-1 (PD-1) monotherapy (nivolumab or pembrolizumab) or targeted therapy consisting of BRAF/MEK inhibitors.

Design
Retrospective chart review study.

Setting
Academic medical centres, community hospitals and private practice offices.

Participants
Included patients diagnosed with melanoma with brain metastasis in the USA.

Outcome measures
The statistical analysis was descriptive in nature. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method and compared between treatments in a univariate Cox proportional hazards model.

Results
In total, 472 patients with MBM who received first-line nivolumab plus ipilimumab (n=246), anti-PD-1 monotherapy (n=112) or BRAF/MEK inhibitors (n=114) were identified. Patients receiving nivolumab plus ipilimumab, compared with patients receiving anti-PD-1 monotherapy or BRAF/MEK inhibitors, had favourable baseline prognostic factors, such as younger age, fewer or smaller brain metastases, better Eastern Cooperative Oncology Group performance status and less frequently elevated lactate dehydrogenase. Median follow-up times were 15.4 months (range 0.1 to 37.0), 13.3 months (range 0.3 to 36.6) and 13.9 months (range 1.9 to 36.5), respectively. Numerically longer OS was observed with nivolumab plus ipilimumab versus anti-PD-1 monotherapy (HR 0.47, 95% CI 0.34 to 0.67) or BRAF/MEK inhibitors (HR 0.72, 95% CI 0.50 to 1.04) and numerically longer PFS was observed with nivolumab plus ipilimumab versus anti-PD-1 monotherapy (HR 0.74, 95% CI 0.53 to 1.02) or BRAF/MEK inhibitors (HR 0.82, 95% CI 0.60 to 1.12). With nivolumab plus ipilimumab, anti-PD-1 monotherapy and BRAF/MEK inhibitors, 1-year OS rates were 79%, 60% and 72%, respectively; 1-year PFS rates were 68%, 58% and 59%.

Conclusions
In this real-world study, first-line nivolumab plus ipilimumab appeared to provide benefit versus anti-PD-1 monotherapy and BRAF/MEK inhibitors in patients with MBM, consistent with pivotal trial data. However, the observed benefit may have been due to confounding and selection bias, given that patients receiving nivolumab plus ipilimumab had favourable baseline prognostic factors compared with patients receiving anti-PD-1 monotherapy or BRAF/MEK inhibitors.

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Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial

Introduction
Weight restoration is a primary goal in anorexia nervosa (AN) treatment. Recent studies suggest that addressing physical activity urges in patients with AN is a promising target to facilitate weight restoration. This trial will evaluate the feasibility of a virtual reality (VR)-based intervention as an add-on treatment to psychotherapy to improve activity urges and, consequently, initial treatment responses on core outcomes as targeted per AN treatment guidelines.

Methods and analysis
This single-centre feasibility trial adopts the single-blind, two-arm design and outcome measures of an intended full-scale randomised controlled trial (RCT) in order to establish that all necessary trial components work together as intended. It will evaluate feasibility as the primary endpoint and compare changes in ratings of the urge to be active between patients with AN randomly assigned to receiving VR intervention sessions and patients with AN in a control procedure. The feasibility of the full-scale RCT will depend on whether patients (1) will evaluate the experience as acceptable, (2) tolerate VR side effects and (3) will adhere to the intended intervention schedule. We define a set of three-tiered, formal progression criteria and employ a ‘traffic light system’ demarcating go (green), amend (amber) and stop (red) signals for advancing to the full-scale RCT.

Ethics and dissemination
The study was approved by the ethics committee of the Ruhr University Bochum’s Medical Faculty at Campus East-Westphalia (AZ 2024-1296, 9 December 2024). Patients have to provide written consent before taking part in the study. The findings will be published with open access.

Trial registration number
DRKS00035681, German Clinical Trials Register.

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Policies, programmes and research on adolescent and youth sexual and reproductive health in South Sudan: a systematic scoping review

Objectives
To provide an overview of research, policies and programmes related to the sexual and reproductive health (SRH) needs of adolescents and youth (AY) in South Sudan in order to identify the gaps and potential areas of focus for researchers, policymakers and local and global SRH actors.

Design
Systematic scoping review following the Joanna Briggs Institute criteria for evidence synthesis.

Data sources
Medline, Embase and Global Health were searched for articles dated between 9 July 2011 and 13 July 2023. A grey literature search was conducted using Google search engine and on the websites of key stakeholders.

Eligibility criteria for selecting studies
We included all types of studies, policies, reports and programmes that pertained to any aspect of the SRH AY (ages 10–35) in South Sudan.

Data extraction and synthesis
All articles were screened by the first author using the predetermined eligibility criteria. A secondary review was conducted on all selected articles to ensure alignment with criteria. Data were extracted from all eligible articles using an established data extraction tool. The authors identified overarching themes from the extracted data and results were synthesised based on those themes.

Results
We screened 728 articles, resulting in 52 articles included in the review (19 peer-reviewed, 33 grey literature). Results were mapped across South Sudan and synthesised by key AYSRH thematic areas. The results were largely focused on the experiences of adolescent girls and young women and the sociocultural norms and economic challenges that contribute to their lack of access to SRH services and increased risk of experiencing various forms of gender-based violence. Vulnerable populations were excluded from research, policies and programmes, including very young adolescents, LGBTQ youth and youth with disabilities.

Conclusions
Quality research has been done on AYSRH in South Sudan; however, there are many key areas that have not been addressed such as maternal mortality and morbidities, safe abortion and tailored interventions for specific subgroups. While some policies and programmes were identified that address AYSRH, robust programme evaluation processes or evidence of follow-through or implementation of government strategies are lacking.

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Barriers and enablers of access to diabetes eye care in Auckland, New Zealand: a qualitative study

Objective
To explore the barriers and enablers to accessing diabetes eye care services among adults in Auckland.

Design
This was a qualitative study that used semistructured interviews. We performed a thematic analysis and described the main barriers and enablers to accessing services using the Theoretical Domains Framework.

Setting
The study took place in two of the three public funding and planning agencies that provide primary and secondary health services in Auckland, the largest city in Aotearoa New Zealand.

Participants
Thirty people with diabetes in Auckland who had experienced interrupted diabetes eye care, having missed at least one appointment or being discharged back to their general practitioner after missing several appointments.

Results
We identified barriers and enablers experienced by our predominantly Pacific and Māori participants that aligned with 7 (of the 14) domains in the Theoretical Domains Framework. The most reported barriers were transport issues, lack of awareness regarding the importance of retinal screening, time constraints, limited and/or inflexible appointment times and competing family commitments. Enablers included positive interactions with healthcare providers and timely appointment notifications and reminders.

Conclusions
Diabetes eye services could be made more responsive by addressing systemic barriers such as service location and transport links, appointment availability and meaningful information to aid understanding.

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Reducing outpatient wait times through telemedicine: a systematic review and quantitative analysis

Objectives
Population ageing and the rise in chronic diseases place continual stress on healthcare systems. Scarce resources often impede equitable access to healthcare, particularly in rural areas, resulting in prolonged waiting times and heightened risks of morbidity and mortality. Telemedicine has emerged as a promising solution, offering remote and equitable care that could potentially bridge access gaps and enhance health outcomes. This systematic review aims to quantitatively examine the impact of telemedicine implementation on waiting times, defined as the time passed from the booking of a visit for an outpatient to the administration of the service.

Design
A systematic review was conducted using studies on telemedicine interventions that specifically addressed waiting times. Bias assessment was performed with three tools: ROBINS-I (“Risk of Bias In Non-Randomized Studies of Interventions”), AXIS (“Appraisal tool for Cross-Sectional Studies”) and RoB-2 (“Risk of Bias-2”). A weighted mean approach was used to synthesise results, with medians synthesised using a median approach.

Data sources
Articles in English were retrieved from the PubMed and Scopus databases.

Eligibility criteria
Studies were excluded if they did not specifically address waiting times related to telemedicine interventions. Only studies that considered waiting times defined as the time passed from the booking of a visit for an outpatient to the administration of the service and any telemedicine intervention were included.

Data extraction and synthesis
A total of 53 records were included, encompassing 270 388 patients in both the experimental and control groups. The weighted mean reduction in waiting times was calculated, and bias was assessed. No record was evaluated to be at high risk of bias, with 69.8% of studies evaluated at low risk and 26.4% at moderate risk (3.8% were surveys). Results were synthesised using a weighted mean approach for studies reporting means, and a median approach for studies reporting medians.

Results
Overall, a weighted mean reduction of 25.4 days in waiting times was observed. Focusing on clinical specialties (n=114 042), the weighted mean reduction amounted to 34.7 days, while in surgical patients (n=156 346), telemedicine was associated with a weighted mean of 17.3 days saved.

Conclusions
The implementation of telemedicine solutions may significantly improve waiting times, potentially leading to more efficient and equitable healthcare systems.

PROSPERO registration number
CRD42023490822.

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Abstract TMP28: Synergistic Effect of Hospital Prenotification and RAPIDAI on Thrombectomy Times in Large Telemedicine System

Stroke, Volume 56, Issue Suppl_1, Page ATMP28-ATMP28, February 1, 2025. Background:The utilization of artificial intelligence (AI) platforms to provide rapid access to images, LVO detection, and team communication in acute stroke protocols is expanding globally. The VALIDATE study showed that Viz.ai was correlated with significant decrease in arrival to neurointerventionalist notification time of 40 minutes and a synergistic effect with hospital pre-notification. The study aims to assess if these findings are generalizable to other AI platforms specifically RAPIDAI.Methods:Acute stroke consultations seen in the emergency department in 103 facilities (35 RAPID AI and 68 no-AI) in 24 states from July 1, 2021 to December 31, 2021 were extracted from the TeleCare by TeleSpecialistsTMdatabase. The encounters were reviewed for demographics, LVO, accepted for intervention, arrival to NIR notification time (ATN), and RAPIDAI software used. Patients were classified into two groups based on use of RAPIDAI or no AI software as well as hospital pre-notification of teleneurologist vs pre-notifications cases excluded. The median arrival to NIR notification times were compared.Results:A total of 14,159 patients were included: No AI group (7,433), and RAPIDAI (6,726). The median arrival to NIR notification time for No AI group was 88.5 minutes when compared to RAPIDAI groups 57.5 minutes was significantly longer, p

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Abstract WP187: Graph neural networks for impossible transfemoral access pre-procedural prediction in stroke mechanical thrombectomy

Stroke, Volume 56, Issue Suppl_1, Page AWP187-AWP187, February 1, 2025. Introduction:3 to 5% of patients undergoing endovascular thrombectomy present impossible catheter access to the occlusion site from transfemoral access (TFA), largely attributed to complex arterial anatomy. Radial access can be an effective bailout strategy, but intraprocedural delays may negatively impact outcomes. Novel image processing algorithms allow for advanced characterization of vascular pathways from baseline neuroimaging, enabling the exploration of predictive models of impossible TFA before arterial puncture.Methods:A retrospective cohort of patients with an anterior large vessel occlusion who received thrombectomy from TFA between 2017 and 2023 were included in this study. A previously described automatic vascular analysis software was used to generate centerline graphs from the aorta to the intracranial occlusion site from baseline CTA. ArterialGNet, a graph neural network based on graph attention designed to integrate descriptors of centerline pathways extracted at three different distance scales, was trained for impossible TFA prediction. Five-fold cross validation was used for model derivation. The method was compared to a previously introduced random forest ensemble model with extreme gradient boosting (XGBRF) based on six vascular tortuosity descriptors of the aortic and supra-aortic regions.Results:A total of 745 patients (aged 78 years IQR 68-85, 56% women) were included in this study. Patients treated between 2017 to 2022 (n=568, 3.2% with impossible TFA) were used for model training and validation. Patients treated in 2023 (n=177, 3.4% with impossible TFA) were held out for testing. In validation, the best-performing configuration of ArterialGNet achieved a C-statistic of 0.82 (95%CI 0.74-0.90), similar to the baseline model (0.82, 95%CI 0.77-0.88). Comparable outcomes were observed in the final testing for ArterialGNet (0.84, 95%CI: 0.82–0.86). In contrast, the XGBRF model exhibited signs of overfitting (0.65, 95% CI: 0.53–0.78). In final testing, ArterialGNet predicted impossible TFA with a sensitivity of 0.80 (95%CI 0.66-0.94) and a specificity of 0.84 (95%CI 0.76-0.91). Median processing time for ArterialGNet was below 4 min.Conclusions:A novel model for impossible TFA prediction was validated with a large dataset. Impossible TFA prediction before arterial puncture may assist in decision support for initial access selection in thrombectomy, reducing intraprocedural delays and potentially improving clinical outcomes.

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