Contextualizing remote fall risk: Video data capture and implementing ethical AI.

Wearable inertial measurement units (IMUs) are being used to quantify gait characteristics that are associated with increased fall risk, but the current limitation is the lack of contextual information that would clarify IMU data. Use of wearable video-based cameras would provide a comprehensive understanding of an individual's habitual fall risk, adding context to clarify abnormal IMU data. Generally, there is taboo when suggesting the use of wearable cameras to capture real-world video, clinical and patient apprehension due to ethical and privacy concerns. This perspective proposes that routine use of wearable cameras could be realized within digital medicine through AI-based computer vision models to obfuscate/blur/shade sensitive information while preserving helpful contextual information for a comprehensive patient assessment. Specifically, no person sees the raw video data to understand context, rather AI interprets the raw video data first to blur sensitive objects and uphold privacy. That may be more routinely achieved than one imagines as contemporary resources exist. Here, to showcase/display the potential an exemplar model is suggested via off-the-shelf methods to detect and blur sensitive objects (e.g., people) with an accuracy of 88%. Here, the benefit of the proposed approach includes a more comprehensive understanding of an individual's free-living fall risk (from free-living IMU-based gait) without compromising privacy. More generally, the video and AI approach could be used beyond fall risk to better inform habitual experiences and challenges across a range of clinical cohorts. Medicine is becoming more receptive to wearables as a helpful toolbox, camera-based devices should be plausible instruments.

The impact of large core and late treatment trials: An update on the modelled annual thrombectomy eligibility of UK stroke patients.

INTRODUCTION: To support decisions about thrombectomy provision, we have previously estimated the annual UK population eligible for treatment as ∼10% of stroke admissions. Since then, eight further randomised trials that could alter the eligibility rate have reported in 2021-23. We updated our estimates of the eligible population from these trials and other recent studies. PATIENTS AND METHODS: An updated decision tree describing the EVT eligible population for UK stroke admissions was produced. Decision criteria were derived from the highest level of evidence available. For nodes where no specific RCT data existed, evidence was obtained from the latest systematic review(s) or the highest quality observational data. RESULTS: We estimate that 15,420 (approximately 15%) of admitted UK stroke patients are now eligible for thrombectomy, or 14,930 if advanced brain imaging using MRI/CT perfusion or collateral assessment were used in all patients. This is a 54% increase in our previous estimate in 2021. Over 50% of LAO strokes are now potentially eligible for thrombectomy. The increase in eligibility is principally due to a much larger cohort of later presenting and/or larger ischaemic core patients. CONCLUSION: Most previously independent LAO stroke patients presenting within 24 h, even in the presence of a large ischaemic core on initial non-contrast CT, should be considered for thrombectomy with use of advanced brain imaging in those presenting beyond 12 h to identify salvageable penumbral brain tissue. Treatment in most patients remains critically time-dependent and our estimates should be interpreted with this in mind.

Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation.

BACKGROUND: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. METHODS: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0-100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. DISCUSSION: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. TRIAL REGISTRATION: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021.

Costs of endovascular and open repair of thoracic aortic aneurysms.

BACKGROUND: Repair of thoracic aortic aneurysms with either endovascular repair (TEVAR) or open surgical repair (OSR) represents major surgery, is costly and associated with significant complications. The aim of this study was to establish accurate costs of delivering TEVAR and OSR in a cohort of UK NHS patients suitable for open and endovascular treatment for the whole treatment pathway from admission and to discharge and 12-month follow-up. METHODS: A prospective study of UK NHS patients from 30 NHS vascular/cardiothoracic units in England aged ≥18, with distal arch/descending thoracic aortic aneurysms (CTAA) was undertaken. A multicentre prospective cost analysis of patients (recruited March 2014-July 2018, follow-up until July 2019) undergoing TEVAR or OSR was performed. Patients deemed suitable for open or endovascular repair were included in this study. A micro-costing approach was adopted. RESULTS: Some 115 patients having undergone TEVAR and 35 patients with OSR were identified. The mean (s.d.) cost of a TEVAR procedure was higher £26 536 (£9877) versus OSR £17 239 (£8043). Postoperative costs until discharge were lower for TEVAR £7484 (£7848) versus OSR £28 636 (£23 083). Therefore, total NHS costs from admission to discharge were lower for TEVAR £34 020 (£14 301), versus OSR £45 875 (£43 023). However, mean NHS costs for 12 months following the procedure were slightly higher for the TEVAR £5206 (£11 585) versus OSR £5039 (£11 994). CONCLUSIONS: Surgical procedure costs were higher for TEVAR due to device costs. Total in-hospital costs were higher for OSR due to longer hospital and critical care stay. Follow-up costs over 12 months were slightly higher for TEVAR due to hospital readmissions.

Preparing for practice, the effects of repeated immersive simulation on the knowledge and self-efficacy of undergraduate nursing students: A mixed methods study.

AIM: The aim of this study was to compare the effects of two immersive simulation-based education instructional designs, immersive simulation with team deliberate practice and immersive repeated standard simulation, when delivered over the same time on the knowledge and self-efficacy of nursing students. BACKGROUND: Implementing immersive simulation-based education is not without its resource challenges, making it prohibitive for simulation educators to include it in their curricula. Subsequently, there is a need to identify instructional designs that meet these challenges. DESIGN: A two-stage mixed methods approach was used to compare the two instructional designs. METHODS: In stage one, data were collected using questionnaires and differences estimated using analysis of covariance. In stage two, data were collected from two focus groups and analysed using a qualitative content analysis approach. Data were collected as part of a doctoral study completed in 2019 and was analysed for this study between 2022 and 2023. The justification for this study was that the identification of effective designs for immersive simulation remains a key research priority following the increase in allowable simulation hours by the Nursing and Midwifery Council. RESULTS: In stage one, there was no statistical significance in the participant's knowledge or self-efficacy between the models. In stage two, four themes were identified: vulnerability, development of knowledge, development of self-efficacy and preparation for placement. In contrast to stage one, participants reported that the repeated nature of both designs reinforced their knowledge base increased their self-efficacy, reduced their anxiety levels, and helped them to prepare for placement. CONCLUSION: The results inferred that both designs had a positive impact on the participants. Overall, participants reported that it helped them prepare for placements. Based on the findings, wherever possible, repeated immersive simulation-based education designs should be used and not a standalone immersive simulation-based education scenarios. If resources allow, this could be either a repeated scenario, or if there are resource constraints to use, over the same time, immersive simulation with team deliberate practice, or a similar model. Thus, giving a potential return on investment, one that supports simulation educators making those sensitive decisions regarding the inclusion of immersive simulation with team deliberate practice in their curriculum. Further research is needed into this area to ascertain the design features that maximise this impact and support a move away from standalone scenarios to an approach that uses repetitive immersive simulation.

Developing and piloting an intervention to reduce colposcopy non-attendance and corresponding inequalities: a mixed-methods study.

BACKGROUND: Cervical cancer incidence and mortality is higher in lower income populations. Non-attendance for colposcopy following cervical screening is higher in deprived areas and younger patients. Diagnostic delays reduce the benefits of screening, increasing risk of pre-cancerous cells being undetected or treated later. We aimed to better understand drivers of colposcopy non-attendance and pilot a targeted intervention. Women and people with a cervix (referred to as patients in this paper) access colposcopy services. METHODS: For the service improvement audit, we collected qualitative data from Jan 24 to April 22, 2022, via telephone calls and interviews. The sample included patients who cancelled or did not attend their appointment and patients who attended their appointment. Interviews explored attendance barriers and enablers. Data were analysed thematically and reported, aligning with Consolidated Criteria for reporting Qualitative Studies' principles. The analysis informed development of a pilot intervention, implemented from Aug 8 to Oct 6, 2022, for all scheduled appointments. Patients were contacted by telephone pre-appointment as both a reminder and opportunity to identify and address attendance barriers. Barrier-specific pathways were developed to support attendance (eg, transport assistance). We compared descriptive non-attendance rates during the intervention period and pre-intervention. Audit permission was granted by Northumbria Clinical Audit Team and Caldicott approval obtained. FINDINGS: Data were collected from 20 of the 36 patients who did not attend between Jan 24, and April 22, 2022. Further data were gathered from 88 patients cancelling appointments and four colposcopy attendees. During the audit, ethnicity and gender identity were not routinely collected. Themes identified were administrative, forgetting, anxiety, work, childcare, and transport. During the pilot, 383 (65%) of all 595 patients with an appointment were successfully contacted. The overall non-attendance in 2022 pre-telephone intervention was 10% (195 of 1736 appointments). During the intervention, non-attendance was 8% (45 of 539 appointments). Non-attendance during the intervention was 12% (10 of 87 appointments) for patients aged 25-39 years in the 20% most deprived areas was, compared with 20% (64 of 319 appointments) before the intervention. INTERPRETATION: Identifying and addressing attendance barriers might improve non-attendance, particularly in younger and more deprived populations. This offers the prospect of improving the effectiveness of screening programmes alongside reducing inequalities in health-care access. The findings of this small-scale study are limited to NHS trust colposcopy service in the northeast of England, thus further formalised research is necessary. FUNDING: None.

Better informing everyday fall risk assessment: experimental studies with contemporary technologies.

BACKGROUND: Age-related mobility issues and frailty are a major public health concern because of an increased risk of falls. Subjective assessment of fall risk in the clinic is limited, failing to account for an individual's habitual activities in the home or community. Equally, objective mobility trackers for use in the home and community lack extrinsic (ie, environmental) data capture to comprehensively inform fall risk. We propose a contemporary approach that combines artificial intelligence (AI) and video glasses to augment current methods of fall risk assessment. METHODS: Two case studies were performed to provide a framework to assess extrinsic factors within fall risk assessment via video glasses. The first was AI-based detection of environment and terrain type. We developed convolutional neural networks (CNN) via a bespoke dataset (>145 000 images) captured from different settings (eg, offices, high streets) via free-licenced video on social media. AI automated a textual description to uphold privacy while describing the scene (eg, indoor and carpet). In the second case study, we provided video glasses to participants within a university campus (two men, 17 women; aged 21-60 years) to capture data for automatically labelling environment and objects (eg, fall hazards) via a CNN object detection algorithm. The case studies ran from Dec 5, 2022, to March 24, 2023. FINDINGS: To date, results show promise for the efficient, and accurate AI-based approach to better inform fall risk. Each component of the framework achieved at least 75% accuracy across a range of walks (indoor and outdoor and multiple terrains) from a dataset of 6283 new images. The AI achieved a mean average precision score of 0·93 for the identification of fall risk hazards. INTERPRETATIONS: The AI-based approach provides a contemporary means to better inform fall risk while providing an ethical means to uphold privacy. The proposed approach could have significant implications for improving overall health and quality of life, enabling ageing in place through habitual data collection with contemporary wearables to decentralise fall risk assessment. A limitation was the lack of data collection on older adults within real world, unscripted settings. However, the next phase of this research is the deployment of the AI on real-world data from a cohort of more than 40 participants within UK-based homes. FUNDING: National Institute of Health and Care Research (NIHR) Applied Research Collaboration (ARC) North-East and North Cumbria (NENC), Faculty of Engineering and Environment at Northumbria University.

Gait retraining to reduce falls: an experimental study toward scalable and personalised use in the home.

BACKGROUND: Age-related neurological conditions can result in poor mobility typified by gait abnormalities and falls, increasing risk of frailty and lowering quality of life. In the UK, the expense and inaccessibility of services to improve mobility through gait training (eg, auditory cueing) is a public health issue. Contemporary and scalable pervasive technologies for widespread public use could provide an affordable and accessible solution. We aimed to show the preliminary efficacy of a novel smartphone app that provides a personalised approach to mobility and gait assessment while facilitating gait training. METHODS: In this experimental study, we recruited participants aged 22-46 years with no physical functional impairments (ie, no age-related neurological condition and who could walk unaided) from Northumbria University staff (Newcastle upon Tyne, UK) between April 19, and May 26. Participants wore a smartphone on their lower back. Inertial data from the smartphone were recorded during two walks, one at a self-selected pace and the other with a personalised auditory cue via headphones (+10% pace on walk 1). Smartphone app functionality enabled the measurement of clinically relevant gait characteristics via a Python-based Cloud server. We compared smartphone-based mobility or gait characteristics with a gold-standard reference (Opal Mobility Lab, APDM). We used Pearson and intraclass correlation coefficients (ICC2,1) to examine agreement between the novel app and reference. The study ran from April 4 to July 21, 2023. This study received ethics approval from the Northumbria University Ethics committee, and all participants provided written informed consent. FINDINGS: Ten adults were recruited (six women and four men; mean age 27·4 years [SD 6·2], mean weight 79·6 kg [SD 12·7], mean height 174·7 cm [SD 7·9]). High levels of agreement were found between the smartphone app and reference, quantified by Pearson (≥0·858) and ICC values (≥0·911). The personalised cueing intervention increased the mean cadence by an average of 11%, which shows good participant adherence to cueing via an app. INTERPRETATION: Here, we propose a contemporary approach to increase the accessibility to a health-based intervention. Preliminary findings suggest the smartphone app is a suitable tool for personalised mobility or gait assessment while facilitating gait training. Use of a scalable app could be an accessible and affordable method for improving mobility to reduce falls in the home. Here, current limitations are the lack of investigation with the smartphone app for neurological gait assessment on older adults and the lack of information on participants app experience, but this will be included in future work. The pervasive use of smartphones enables a decentralised approach to overcoming issues such as frailty and logistical challenges of travelling to bespoke clinics. FUNDING: National Institute of Health and Care Research (NIHR) Applied Research Collaboration (ARC) North-East and North Cumbria (NENC); Faculty of Engineering and Environment at Northumbria University.

Robotic and laparoscopic gynaecological surgery: a prospective multicentre observational cohort study and economic evaluation in England.

OBJECTIVE: To compare the health-related quality of life and cost-effectiveness of robot-assisted laparoscopic surgery (RALS) versus conventional 'straight stick' laparoscopic surgery (CLS) in women undergoing hysterectomy as part of their treatment for either suspected or proven gynaecological malignancy. DESIGN: Multicentre prospective observational cohort study. SETTING: Patients aged 16+ undergoing hysterectomy as part of their treatment for gynaecological malignancy at 12 National Health Service (NHS) cancer units and centres in England between August 2017 and February 2020. PARTICIPANTS: 275 patients recruited with 159 RALS, 73 CLS eligible for analysis. OUTCOME MEASURES: Primary outcome was the European Organisation for Research and Treatment of Cancer Quality of Life measure (EORTC). Secondary outcomes included EuroQol-5 Dimension (EQ-5D-5L) utility, 6-minute walk test (6MWT), NHS costs using pounds sterling (£) 2018-2019 prices and cost-effectiveness. The cost-effectiveness evaluation compared EQ-5D-5L quality adjusted life years and costs between RALS and CLS. RESULTS: No difference identified between RALS and CLS for EORTC, EQ-5D-5L utility and 6MWT. RALS had unadjusted mean cost difference of £556 (95% CI -£314 to £1315) versus CLS and mean quality adjusted life year (QALY) difference of 0.0024 (95% CI -0.00051 to 0.0057), non-parametric incremental cost-effectiveness ratio of £231 667per QALY. For the adjusted cost-effectiveness analysis, RALS dominated CLS with a mean cost difference of -£188 (95% CI -£1321 to £827) and QALY difference of 0.0024 (95% CI -0.0008 to 0.0057). CONCLUSIONS: Findings suggest that RALS versus CLS in women undergoing hysterectomy (after adjusting for differences in morbidity) is cost-effective with lower costs and QALYs. Results are highly sensitive to the usage of robotic hardware with higher usage increasing the probability of cost-effectiveness. Non-inferiority randomised controlled trial would be of benefit to decision-makers to provide further evidence on the cost-effectiveness of RALS versus CLS but may not be practical due to surgical preferences of surgeons and the extensive roll out of RALS.

Investigating changes in mental health services utilisation in England and their impact on health outcomes and wellbeing during the COVID-19 pandemic: Protocol for a health data-linkage study.

INTRODUCTION: Linking routinely collected health care system data records for the same individual across different services and over time has enormous potential for the NHS and its patients. The aims of this data linkage study are to quantify the changes to mental health services utilisation in responses to the COVID-19 pandemic and determine whether these changes were associated with health-related outcomes and wellbeing among people living in the most deprived communities in North East and North Cumbria, England. METHODS AND ANALYSIS: We will assemble a retrospective cohort of people having referred or self-referred to NHS-funded mental health services or Improving Access to Psychological Therapies (IAPT) services between 23rd March 2019 and 22nd March 2020 in the most deprived areas in England. We will link together data from retrospective routinely collected healthcare data including local general practitioner (GP) practice data, Hospital Episode Statistics admitted patient care outpatients, and A&E, Community Services Data Set, Mental Health Services Data Set, and Improving Access to Psychological Therapies Data Set. We will use these linked patient-level data to 1) describe the characteristics of the cohort prior to the lockdown; 2) investigate changes to mental health services utilised between multiple time periods of the COVID-19 lockdown including out of lockdown; 3) explore the relationship between these changes and health outcomes/wellbeing and factors that confound and mediate this relationship among this cohort. STRENGTHS AND LIMITATIONS OF THIS STUDY: This study comprises a deprived population-based cohort of people having referred or self-referred to NHS-funded secondary mental health services or Improving Access to Psychological Therapies (IAPT) services over an extended period of the lockdown in England (2019-2022).This study will utilise a new longitudinal data resource that will link together detailed data from a cohort of individual participants and retrospective administrative data relating to the use of primary, secondary, and community care services.The study period covers pre-lockdown, different lockdown and post-lockdown, and out of lockdown periods up to March 2022.Routinely collected administrative data contain limited contextual information and represent an underestimate of total health outcomes for these individuals.Routinely collected datasets can often been incomplete or contain missing data, which can make it difficult to accurately analyse the data and draw meaningful conclusions.Intervention and treatment for mental health conditions are not wholly captured across these data sources and may impact health outcomes.

Enhancing Free-Living Fall Risk Assessment: Contextualizing Mobility Based IMU Data.

Fall risk assessment needs contemporary approaches based on habitual data. Currently, inertial measurement unit (IMU)-based wearables are used to inform free-living spatio-temporal gait characteristics to inform mobility assessment. Typically, a fluctuation of those characteristics will infer an increased fall risk. However, current approaches with IMUs alone remain limited, as there are no contextual data to comprehensively determine if underlying mechanistic (intrinsic) or environmental (extrinsic) factors impact mobility and, therefore, fall risk. Here, a case study is used to explore and discuss how contemporary video-based wearables could be used to supplement arising mobility-based IMU gait data to better inform habitual fall risk assessment. A single stroke survivor was recruited, and he conducted a series of mobility tasks in a lab and beyond while wearing video-based glasses and a single IMU. The latter generated topical gait characteristics that were discussed according to current research practices. Although current IMU-based approaches are beginning to provide habitual data, they remain limited. Given the plethora of extrinsic factors that may influence mobility-based gait, there is a need to corroborate IMUs with video data to comprehensively inform fall risk assessment. Use of artificial intelligence (AI)-based computer vision approaches could drastically aid the processing of video data in a timely and ethical manner. Many off-the-shelf AI tools exist to aid this current need and provide a means to automate contextual analysis to better inform mobility from IMU gait data for an individualized and contemporary approach to habitual fall risk assessment.

Sonification for Personalised Gait Intervention.

Mobility challenges threaten physical independence and good quality of life. Often, mobility can be improved through gait rehabilitation and specifically the use of cueing through prescribed auditory, visual, and/or tactile cues. Each has shown use to rectify abnormal gait patterns, improving mobility. Yet, a limitation remains, i.e., long-term engagement with cueing modalities. A paradigm shift towards personalised cueing approaches, considering an individual's unique physiological condition, may bring a contemporary approach to ensure longitudinal and continuous engagement. Sonification could be a useful auditory cueing technique when integrated within personalised approaches to gait rehabilitation systems. Previously, sonification demonstrated encouraging results, notably in reducing freezing-of-gait, mitigating spatial variability, and bolstering gait consistency in people with Parkinson's disease (PD). Specifically, sonification through the manipulation of acoustic features paired with the application of advanced audio processing techniques (e.g., time-stretching) enable auditory cueing interventions to be tailored and enhanced. These methods used in conjunction optimize gait characteristics and subsequently improve mobility, enhancing the effectiveness of the intervention. The aim of this narrative review is to further understand and unlock the potential of sonification as a pivotal tool in auditory cueing for gait rehabilitation, while highlighting that continued clinical research is needed to ensure comfort and desirability of use.

The impact of a digital joint school educational programme on post-operative outcomes following lower limb arthroplasty: a retrospective comparative cohort study.

BACKGROUND: As part of an ongoing service improvement project, a digital 'joint school' (DJS) was developed to provide education and support to patients undergoing total hip (THR) and total knee (TKR) replacement surgery. The DJS allowed patients to access personalised care plans and educational resources using web-enabled devices, from being listed for surgery until 12 months post-operation. The aim of this study was to compare a cohort of patients enrolled into the DJS with a cohort of patients from the same NHS trust who received a standard 'non-digital' package of education and support in terms of Health-Related Quality of Life (HRQoL), functional outcomes and hospital length of stay (LoS). METHODS: A retrospective comparative cohort study of all patients undergoing primary TKR/THR at a single NHS trust between 1st Jan 2018 and 31st Dec 2019 (n = 2406) was undertaken. The DJS was offered to all patients attending the clinics of early adopting surgeons and the remaining surgeons offered their patient's standard written and verbal information. This allowed comparison between patients that received the DJS (n = 595) and those that received standard care (n = 1811). For each patient, demographic data, LoS and patient reported outcome measures (EQ-5D-3L, Oxford hip/knee scores (OKS/OHS)) were obtained. Polynomial regressions, adjusting for age, sex, Charlson Comorbidity Index (CCI) and pre-operative OKS/OHS or EQ-5D, were used to compare the outcomes for patients receiving DJS and those receiving standard care. FINDINGS: Patients that used the DJS had greater improvements in their EQ-5D, and OKS/OHS compared to patients receiving standard care for both TKR and THR (EQ-5D difference: TKR coefficient estimate (est) = 0.070 (95%CI 0.004 to 0.135); THR est = 0.114 (95%CI 0.061 to 0.166)) and OKS/OHS difference: TKR est = 5.016 (95%CI 2.211 to 7.820); THR est = 4.106 (95%CI 2.257 to 5.955)). The DJS had a statistically significant reduction on LoS for patients who underwent THR but not TKR. CONCLUSION: The use of a DJS was associated with improved functional outcomes when compared to a standard 'non-digital' method. The improvements between pre-operative and post-operative outcomes in EQ-5D and OKS/OHS were higher for patients using the DJS. Furthermore, THR patients also had a shorter LoS.

National implementation of reperfusion for acute ischaemic stroke in England: How should services be configured? A modelling study.

Objectives: To guide policy when planning thrombolysis (IVT) and thrombectomy (MT) services for acute stroke in England, focussing on the choice between 'mothership' (direct conveyance to an MT centre) and 'drip-and-ship' (secondary transfer) provision and the impact of bypassing local acute stroke centres. Design: Outcome-based modelling study. Setting: 107 acute stroke centres in England, 24 of which provide IVT and MT (IVT/MT centres) and 83 provide only IVT (IVT-only units). Participants: 242,874 emergency admissions with acute stroke over 3 years (2015-2017). Intervention: Reperfusion delivered by drip-and-ship, mothership or 'hybrid' models; impact of additional travel time to directly access an IVT/MT centre by bypassing a more local IVT-only unit; effect of pre-hospital selection for large artery occlusion (LAO). Main outcome measures: Population benefit from reperfusion, time to IVT and MT, admission numbers to IVT-only units and IVT/MT centres. Results: Without pre-hospital selection for LAO, 94% of the population of England live in areas where the greatest clinical benefit, assuming unknown patient status, accrues from direct conveyance to an IVT/MT centre. However, this policy produces unsustainable admission numbers at these centres, with 78 out of 83 IVT-only units receiving fewer than 300 admissions per year (compared to 3 with drip-and-ship). Implementing a maximum permitted additional travel time to bypass an IVT-only unit, using a pre-hospital test for LAO, and selecting patients based on stroke onset time, all help to mitigate the destabilising effect but there is still some significant disruption to admission numbers, and improved selection of patients suitable for MT selectively reduces the number of patients who would receive IVT at IVT-only centres, challenging the sustainability of IVT expertise in IVT-only centres. Conclusions: Implementation of reperfusion for acute stroke based solely on achieving the maximum population benefit potentially leads to destabilisation of the emergency stroke care system. Careful planning is required to create a sustainable system, and modelling may be used to help planners maximise benefit from reperfusion while creating a sustainable emergency stroke care system.

Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study.

BACKGROUND: The management of chronic thoracic aortic aneurysms includes conservative management, watchful waiting, endovascular stent grafting and open surgical replacement. The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study investigates timing and intervention choice. OBJECTIVE: To describe pre- and post-intervention management of and outcomes for chronic thoracic aortic aneurysms. DESIGN: A systematic review of intervention effects; a Delphi study of 360 case scenarios based on aneurysm size, location, age, operative risk and connective tissue disorders; and a prospective cohort study of growth, clinical outcomes, costs and quality of life. SETTING: Thirty NHS vascular/cardiothoracic units. PARTICIPANTS: Patients aged > 17 years who had existing or new aneurysms of ≥ 4 cm in diameter in the arch, descending or thoracoabdominal aorta. INTERVENTIONS: Endovascular stent grafting and open surgical replacement. MAIN OUTCOMES: Pre-intervention aneurysm growth, pre-/post-intervention survival, clinical events, readmissions and quality of life; and descriptive statistics for costs and quality-adjusted life-years over 12 months and value of information using a propensity score-matched subsample. RESULTS: The review identified five comparative cohort studies (endovascular stent grafting patients, n = 3955; open surgical replacement patients, n = 21,197). Pooled short-term all-cause mortality favoured endovascular stent grafting (odds ratio 0.71, 95% confidence interval 0.51 to 0.98; no heterogeneity). Data on survival beyond 30 days were mixed. Fewer short-term complications were reported with endovascular stent grafting. The Delphi study included 20 experts (13 centres). For patients with aneurysms of ≤ 6.0 cm in diameter, watchful waiting was preferred. For patients with aneurysms of > 6.0 cm, open surgical replacement was preferred in the arch, except for elderly or high-risk patients, and in the descending aorta if patients had connective tissue disorders. Otherwise endovascular stent grafting was preferred. Between 2014 and 2018, 886 patients were recruited (watchful waiting, n = 489; conservative management, n = 112; endovascular stent grafting, n = 150; open surgical replacement, n = 135). Pre-intervention death rate was 8.6% per patient-year; 49.6% of deaths were aneurysm related. Death rates were higher for women (hazard ratio 1.79, 95% confidence interval 1.25 to 2.57; p = 0.001) and older patients (age 61-70 years: hazard ratio 2.50, 95% confidence interval 0.76 to 5.43; age 71-80 years: hazard ratio 3.49, 95% confidence interval 1.26 to 9.66; age > 80 years: hazard ratio 7.01, 95% confidence interval 2.50 to 19.62; all compared with age < 60 years, p < 0.001) and per 1-cm increase in diameter (hazard ratio 1.90, 95% confidence interval 1.65 to 2.18; p = 0.001). The results were similar for aneurysm-related deaths. Decline per year in quality of life was greater for older patients (additional change -0.013 per decade increase in age, 95% confidence interval -0.019 to -0.007; p < 0.001) and smokers (additional change for ex-smokers compared with non-smokers 0.003, 95% confidence interval -0.026 to 0.032; additional change for current smokers compared with non-smokers -0.034, 95% confidence interval -0.057 to -0.01; p = 0.004). At the time of intervention, endovascular stent grafting patients were older (age difference 7.1 years; 95% confidence interval 4.7 to 9.5 years; p < 0.001) and more likely to be smokers (75.8% vs. 66.4%; p = 0.080), have valve disease (89.9% vs. 71.6%; p < 0.0001), have chronic obstructive pulmonary disease (21.3% vs. 13.3%; p = 0.087), be at New York Heart Association stage III/IV (22.3% vs. 16.0%; p = 0.217), have lower levels of haemoglobin (difference -6.8 g/l, 95% confidence interval -11.2 to -2.4 g/l; p = 0.003) and take statins (69.3% vs. 42.2%; p < 0.0001). Ten (6.7%) endovascular stent grafting and 15 (11.1%) open surgical replacement patients died within 30 days of the procedure (p = 0.2107). One-year overall survival was 82.5% (95% confidence interval 75.2% to 87.8%) after endovascular stent grafting and 79.3% (95% confidence interval 71.1% to 85.4%) after open surgical replacement. Variables affecting survival were aneurysm site, age, New York Heart Association stage and time waiting for procedure. For endovascular stent grafting, utility decreased slightly, by -0.017 (95% confidence interval -0.062 to 0.027), in the first 6 weeks. For open surgical replacement, there was a substantial decrease of -0.160 (95% confidence interval -0.199 to -0.121; p < 0.001) up to 6 weeks after the procedure. Over 12 months endovascular stent grafting was less costly, with higher quality-adjusted life-years. Formal economic analysis was unfeasible. LIMITATIONS: The study was limited by small numbers of patients receiving interventions and because only 53% of patients were suitable for both interventions. CONCLUSIONS: Small (4-6 cm) aneurysms require close observation. Larger (> 6 cm) aneurysms require intervention without delay. Endovascular stent grafting and open surgical replacement were successful for carefully selected patients, but cost comparisons were unfeasible. The choice of intervention is well established, but the timing of intervention remains challenging. FUTURE WORK: Further research should include an analysis of the risk factors for growth/rupture and long-term outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04044627 and NCT02010892. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 6. See the NIHR Journals Library website for further project information.

The aorta is the main artery that carries oxygen-rich blood from the heart to the body. An aneurysm is a swelling or bulging in a blood vessel, which usually occurs where the wall has become weak and has lost its elastic properties, which means that it does not return to its normal shape after the blood has passed through. A thoracic aortic aneurysm, or TAA for short, is an aneurysm in the section of the aorta in the chest (www.bhf.org.uk/informationsupport/conditions/thoracic-aortic-aneurysms). The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study aimed to investigate aneurysm growth rates, patient outcomes, quality of life and costs, including those from surgery. Surgical treatments include open heart surgery, in which the section of the aorta that contains the aneurysm is removed and replaced by a new aorta made from a synthetic material, and stent grafting, in which tubes are inserted into arteries to allow blood to flow freely, using less invasive 'keyhole' surgery. The existing research evidence was reviewed, but data comparing the effectiveness of these two approaches were sparse or of limited quality, and outdated. Between 2014 and 2018, clinical experts were surveyed and 886 NHS patients with chronic thoracic aortic aneurysms (≥ 4 cm in diameter) were observed to monitor aneurysm growth and patient outcomes. If patients were unfit or unwilling to have surgery, they had conservative management with medication and lifestyle changes. For small aneurysms, experts recommended watchful waiting, with regular monitoring, until the aneurysm grew to about 6 cm in diameter. Open surgery was preferred for larger arch aneurysms and for descending aneurysms in patients with genetic disorders. Otherwise, stent grafting was preferred. The observational study recruited 321 women and 565 men with an average age of 71 years from 30 English hospitals. A total of 489 patients underwent watchful waiting and 112 received conservative management. Without surgery, death rates were higher for women and older patients, while the risk of dying doubled for each centimetre of aneurysm diameter at baseline. Of the remaining patients, 150 underwent stent grafting and 135 had open surgery. One-year overall survival was 83% after stent grafting and 79% after open surgery but the difference could be due to chance. The factors affecting survival after stent grafting or open surgery were aneurysm location, age, breathlessness and time waiting for a procedure. Small aneurysms are low risk, so blood pressure management and smoking cessation are recommended. For larger aneurysms, it is important that surgery is not delayed, as a longer waiting time to surgery means that outcomes are poorer. Only about half of patients who had surgery were considered suitable for both stent grafting and open surgery, which limited the ability to determine the best use of NHS resources. No comparative cost-effectiveness analysis was feasible. The main cost in a stent grafting procedure was the stent graft, and the main cost in an open surgery procedure was days in an intensive care unit.

An analysis of the COVID-19 vaccination campaigns in France, Israel, Italy and Spain and their impact on health and economic outcomes.

Objectives: This paper presents an overview of the vaccination campaigns in France, Israel, Italy and Spain during the first eleven months from the first COVID-19 vaccine approval (Dec 2020 - Nov 2021). These four countries were chosen as they share similar socioeconomic, and epidemiological profiles and adopted similar vaccination strategies. Methods: A rapid review of available primary data from each country was conducted. Data were collected from official government documents whenever possible, supplemented by information from international databases and local reports. The data were analysed via descriptive and graphical analysis to identify common patterns as well as significant divergences in the structural changes of countries' healthcare systems during the pandemic, outcomes of the vaccination roll-out, and their impact on contextual policies. Results: The four countries adopted similar interventions to protect and strengthen their healthcare systems. The effective coordination between the governance levels, ability to ensure a large supply of doses, and trust towards health authorities were amongst the determinants for more successful vaccination outcomes. The analysis reports a positive impact of the COVID-19 vaccines on epidemiological, political and economic outcomes. We observed some evidence of a negative association between increased vaccine coverage and fatalities and hospitalisation trends. Conclusions: The strengths and weaknesses of COVID-19 pandemic crisis management along with the various strategies surrounding the vaccination roll-out campaigns may yield lessons for policymakers amidst such decisions, including for future pandemics. Lay summary: This paper presents an overview of the vaccination campaigns in France, Israel, Italy and Spain during the first eleven months following approval of the first COVID-19 vaccine (Dec 2020 - Nov 2021). These four countries were chosen as they share similar demographic, socioeconomic, and epidemiological profiles, and adopted similar vaccinations strategies. Effective coordination between governance levels, ability to ensure a large supply of doses, and trust towards health authorities were amongst the determinants for successful outcomes of vaccination campaigns. The strengths and weaknesses of COVID-19 pandemic crisis management, along with the various strategies surrounding the vaccination roll-out campaigns may yield lessons for policymakers amidst such decisions, including for future pandemics.

Primary Sjögren's syndrome: Longitudinal real-world, observational data on health-related quality of life.

INTRODUCTION: Primary Sjögren's syndrome (pSS) is a chronic inflammatory condition, which presents with symptoms of dryness, pain, fatigue and often symptoms of anxiety and depression. Health-related quality of life (HRQoL) is significantly reduced in pSS and the direct and indirect health costs of pSS are substantial. This study aims to determine how symptom burden, disease activity and demographics associate with HRQoL longitudinally over a median of 24-month follow-up period in pSS. METHODS: Longitudinal EuroQoL-5 dimension (EQ-5D)-3L data from the Newcastle pSS cohort (n = 377) were evaluated using a survival analysis strategy. Kaplan-Meier and Cox proportional hazards analysis were performed using baseline Newcastle Sjogren's Stratification Tool (NSST) subgroup, EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI), disease duration, age and sex as covariates including polypharmacy and comorbidity score, where data were available (n = 191). RESULTS: Of the 377 pSS participants analysed in this study, 16% experienced a decline in HRQoL to a health state comparable to or worse than death. NSST subgroup and ESSPRI score had a significant relationship with time to 'EQ-5D event', whereas baseline ESSDAI, age, disease duration and sex did not. CONCLUSION: In pSS, symptom burden and to a great extent NSST subgroup, rather than systemic disease activity, has a significant relationship with HRQoL longitudinally. Improvements in symptom burden have the potential to produce significant impacts on long-term HRQoL in pSS.

Is fear of falling key to identifying gait and balance abnormalities in community-dwelling older adults? Protocol of a mixed-methods approach.

INTRODUCTION: The ageing population poses an increasing burden to public health systems, particularly as a result of falls. Falls have been associated with poor gait and balance, as measured by commonly used clinical tests for poor gait and balance. Falls in older adults have the potential to lead to long-term issues with mobility and a fear of falling (FoF). FoF is measured by a variety of instruments; the Falls Efficacy Scale International (FES-I) version is widely used within clinical and research arenas. The ability of the FoF, as measured by the FES-I to predict gait and balance abnormalities (GABAb) has not previously been measured; this study aims to be the first to investigate this prospective relationship. METHODS AND ANALYSES: To investigate the ability of the FES-I to predict GABAb a mixed-methods approach will be used, including quantitative, qualitative and health economics approaches. Initially the ability of the FES-I to identify poor gait and balance will be investigated, along with whether the measure is able to assess change in gait and balance in response to exercise training. The ability of an online FES-I tool to assess poor gait and balance in an alternative pre-existing online strength and balance programme will also be investigated. Interviews will be carried out to investigate participant experiences and motivations of those that are offered Age UK Strength and Balance Training, along with the views of healthcare professionals and Age UK staff involved within the process. ETHICS AND DISSEMINATION: NHS REC Approval has been granted (IRAS ID 314705). Study participation is voluntary; participants will be provided with all necessary information within the participant information sheet, with written consent being sought. Study findings will be disseminated through manuscripts in peer-reviewed journals, at scientific conferences and in a short report to participants and the funding body.