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.

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.

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.

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.

Enhancing fall risk assessment: instrumenting vision with deep learning during walks.

BACKGROUND: Falls are common in a range of clinical cohorts, where routine risk assessment often comprises subjective visual observation only. Typically, observational assessment involves evaluation of an individual's gait during scripted walking protocols within a lab to identify deficits that potentially increase fall risk, but subtle deficits may not be (readily) observable. Therefore, objective approaches (e.g., inertial measurement units, IMUs) are useful for quantifying high resolution gait characteristics, enabling more informed fall risk assessment by capturing subtle deficits. However, IMU-based gait instrumentation alone is limited, failing to consider participant behaviour and details within the environment (e.g., obstacles). Video-based eye-tracking glasses may provide additional insight to fall risk, clarifying how people traverse environments based on head and eye movements. Recording head and eye movements can provide insights into how the allocation of visual attention to environmental stimuli influences successful navigation around obstacles. Yet, manual review of video data to evaluate head and eye movements is time-consuming and subjective. An automated approach is needed but none currently exists. This paper proposes a deep learning-based object detection algorithm (VARFA) to instrument vision and video data during walks, complementing instrumented gait. METHOD: The approach automatically labels video data captured in a gait lab to assess visual attention and details of the environment. The proposed algorithm uses a YoloV8 model trained on with a novel lab-based dataset. RESULTS: VARFA achieved excellent evaluation metrics (0.93 mAP50), identifying, and localizing static objects (e.g., obstacles in the walking path) with an average accuracy of 93%. Similarly, a U-NET based track/path segmentation model achieved good metrics (IoU 0.82), suggesting that the predicted tracks (i.e., walking paths) align closely with the actual track, with an overlap of 82%. Notably, both models achieved these metrics while processing at real-time speeds, demonstrating efficiency and effectiveness for pragmatic applications. CONCLUSION: The instrumented approach improves the efficiency and accuracy of fall risk assessment by evaluating the visual allocation of attention (i.e., information about when and where a person is attending) during navigation, improving the breadth of instrumentation in this area. Use of VARFA to instrument vision could be used to better inform fall risk assessment by providing behaviour and context data to complement instrumented e.g., IMU data during gait tasks. That may have notable (e.g., personalized) rehabilitation implications across a wide range of clinical cohorts where poor gait and increased fall risk are common.

Aneurysm growth, survival, and quality of life in untreated thoracic aortic aneurysms: the effective treatments for thoracic aortic aneurysms study.

AIMS: To observe, describe, and evaluate management and timing of intervention for patients with untreated thoracic aortic aneurysms. METHODS AND RESULTS: Prospective study of UK National Health Service (NHS) patients aged ≥18 years, with new/existing arch or descending thoracic aortic aneurysms of ≥4 cm diameter, followed up until death, intervention, withdrawal, or July 2019. Outcomes were aneurysm growth, survival, quality of life (using the EQ-5D-5L utility index), and hospital admissions. Between 2014 and 2018, 886 patients were recruited from 30 NHS vascular/cardiothoracic units. Maximum aneurysm diameter was in the descending aorta in 725 (82%) patients, growing at 0.2 cm (0.17-0.24) per year. Aneurysms of ≥4 cm in the arch increased by 0.07 cm (0.02-0.12) per year. Baseline diameter was related to age and comorbidities, and no clinical correlates of growth were found. During follow-up, 129 patients died, 64 from aneurysm-related events. Adjusting for age, sex, and New York Heart Association dyspnoea index, risk of death increased with aneurysm size at baseline [hazard ratio (HR): 1.88 (95% confidence interval: 1.64-2.16) per cm, P < 0.001] and with growth [HR: 2.02 (1.70-2.41) per cm, P < 0.001]. Hospital admissions increased with aneurysm size [relative risk: 1.21 (1.05-1.38) per cm, P = 0.008]. Quality of life decreased annually for each 10-year increase in age [-0.013 (-0.019 to -0.007), P < 0.001] and for current smoking [-0.043 (-0.064 to -0.023), P = 0.004]. Aneurysm size was not associated with change in quality of life. CONCLUSION: International guidelines should consider increasing monitoring intervals to 12 months for small aneurysms and increasing intervention thresholds. Individualized decisions about surveillance/intervention should consider age, sex, size, growth, patient characteristics, and surgical risk.

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.

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.

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.

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.

Systematic review of studies investigating ventilator associated pneumonia diagnostics in intensive care.

BACKGROUND: Ventilator-associated pneumonia (VAP) is an important diagnosis in critical care. VAP research is complicated by the lack of agreed diagnostic criteria and reference standard test criteria. Our aim was to review which reference standard tests are used to evaluate novel index tests for suspected VAP. METHODS: We conducted a comprehensive search using electronic databases and hand reference checks. The Cochrane Library, MEDLINE, CINHAL, EMBASE, and web of science were searched from 2008 until November 2018. All terms related to VAP diagnostics in the intensive treatment unit were used to conduct the search. We adopted a checklist from the critical appraisal skills programme checklist for diagnostic studies to assess the quality of the included studies. RESULTS: We identified 2441 records, of which 178 were selected for full-text review. Following methodological examination and quality assessment, 44 studies were included in narrative data synthesis. Thirty-two (72.7%) studies utilised a sole microbiological reference standard; the remaining 12 studies utilised a composite reference standard, nine of which included a mandatory microbiological criterion. Histopathological criteria were optional in four studies but mandatory in none. CONCLUSIONS: Nearly all reference standards for VAP used in diagnostic test research required some microbiological confirmation of infection, with BAL culture being the most common reference standard used.

Secondary transfer of emergency stroke patients eligible for mechanical thrombectomy by air in rural England: economic evaluation and considerations.

BACKGROUND: Mechanical thrombectomy (MT) is a time-sensitive emergency procedure for patients who had ischaemic stroke leading to improved health outcomes. Health systems need to ensure that MT is delivered to as many patients as quickly as possible. Using decision modelling, we aimed to evaluate the cost-effectiveness of secondary transfer by helicopter emergency medical services (HEMS) compared with ground emergency medical services (GEMS) of rural patients eligible for MT in England. METHODS: The model consisted of (1) a short-run decision tree with two branches, representing secondary transfer transportation strategies and (2) a long-run Markov model for a theoretical population of rural patients with a confirmed ischaemic stroke. Strategies were compared by lifetime costs: quality-adjusted life years (QALYs), incremental cost per QALY gained and net monetary benefit. Sensitivity and scenario analyses explored uncertainty around parameter values. RESULTS: We used the base case of early-presenting (<6 hours to arterial puncture) patient aged 75 years who had stroke to compare HEMS and GEMS. This produced an incremental cost-effectiveness ratio (ICER) of £28 027 when a 60 min reduction in travel time was assumed. Scenario analyses showed the importance of the reduction in travel time and futile transfers in lowering ICERs. For late presenting (>6 hours to arterial puncture), ground transportation is the dominant strategy. CONCLUSION: Our model indicates that using HEMS to transfer patients who had stroke eligible for MT from remote hospitals in England may be cost-effective when: travel time is reduced by at least 60 min compared with GEMS, and a £30 000/QALY threshold is used for decision-making. However, several other logistic considerations may impact on the use of air transportation.

Impact of emergency care centralisation on mortality and efficiency: a retrospective service evaluation.

OBJECTIVE: Evidence favours centralisation of emergency care for specific conditions, but it remains unclear whether broader implementation improves outcomes and efficiency. Routine healthcare data examined consolidation of three district general hospitals with mixed medical admission units (MAU) into a single high-volume site directing patients from the ED to specialty wards with consultant presence from 08:00 to 20:00. METHODS: Consecutive unscheduled adult index admissions from matching postcode areas were identified retrospectively in Hospital Episode Statistics over a 3-year period: precentralisation baseline (from 16 June 2014 to 15 June 2015; n=18 586), year 1 postcentralisation (from 16 June 2015 to 15 June 2016; n=16 126) and year 2 postcentralisation (from 16 June 2016 to 15 June 2017; n=17 727). Logistic regression including key demographic covariates compared baseline with year 1 and year 2 probabilities of mortality and daily discharge until day 60 after admission and readmission within 60 days of discharge. RESULTS: Relative to baseline, admission postcentralisation was associated with favourable OR (95% CI) for day 60 mortality (year 1: 0.95 (0.88 to 1.02), p=0.18; year 2: 0.94 (0.91 to 0.97), p<0.01), mainly among patients aged 80+ years (year 1: 0.88 (0.79 to 0.97); year 2: 0.91 (0.87 to 0.96)). The probability of being discharged alive on any day since admission increased (year 1: 1.07 (1.04 to 1.10), p<0.01; year 2: 1.04 (1.02 to 1.05), p<0.01) and the risk of readmission decreased (year 1: 0.90 (0.87 to 0.94), p<0.01; year 2: 0.92 (0.90 to 0.94), p<0.01). CONCLUSION: A centralised site providing early specialist care was associated with improved short-term outcomes and efficiency relative to lower volume ED admitting to MAU, particularly for older patients.

Evaluation of an Extended Stroke Rehabilitation Service (EXTRAS): A Randomized Controlled Trial and Economic Analysis.

Background and Purpose- There is limited evidence to guide rehabilitation to meet the longer term needs of stroke survivors. The clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS) provided following early supported discharge were determined. Methods- EXTRAS was a pragmatic parallel-group observer-blind randomized controlled trial involving 19 UK centers. Patients with stroke were individually randomized to receive EXTRAS or usual care at discharge from early supported discharge. Five EXTRAS reviews were provided by an early supported discharge team member between one and 18 months, usually by telephone. Reviews consisted of a semi-structured interview assessing progress, rehabilitation needs, and service provision, with goal setting and action planning. The primary outcome was performance in extended activities of daily living (Nottingham EADL Scale) at 24 months post-randomization. The Nottingham EADL Scale is scored 0 to 66, with higher scores indicating better performance in these activities. Cost-effectiveness was estimated using resource utilization costs and Quality Adjusted Life Years. Analyses were intention to treat. Results- Between January 9, 2013 and October 26, 2015, 573 participants were randomized (EXTRAS, n=285; usual care, n=288). Mean 24 month Nottingham EADL Scale scores were EXTRAS (n=219) 40.0 (SD 18.1) and usual care (n=231) 37.2 (SD 18.5) giving an adjusted mean difference of 1.8 (95% CI, -0.7 to 4.2). 1155/1338 (86%) of expected EXTRAS reviews were undertaken. Over 24 months, the mean cost of resource utilization was lower in the intervention group: -£311 (-$450 [95% CI, -£3292 to £2787; -$4764 to $4033]). EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]). At current conventional thresholds of willingness to pay (£20 000 [$28 940] per Quality Adjusted Life Years), there was a 90% chance that EXTRAS could be considered cost-effective. Conclusions- EXTRAS did not significantly improve stroke survivors' performance in extended activities of daily living. However, given the impact on costs and Quality Adjusted Life Years, EXTRAS may be an affordable addition to improve stroke care. Clinical Trial Registration- URL: www.isrctn.com. Unique identifier: ISRCTN45203373.

Rapid evaluation for health and social care innovations: challenges for "quick wins" using interrupted time series.

BACKGROUND: Rapid evaluation was at the heart of National Health Service England's evaluation strategy of the new models of care vanguard programme. This was to facilitate the scale and spread of successful models of care throughout the health & social care system. The aim of this paper is to compare the findings of the two evaluations of the Enhanced health in Care Homes (EHCH) vanguard in Gateshead, one using a smaller data set for rapidity and one using a larger longitudinal data set and to investigate the implications of the use of rapid evaluations using interrupted time series (ITS) methods. METHODS: A quasi-experimental design study in the form of an ITS was used to evaluate the impact of the vanguard on secondary care use. Two different models are presented differing by timeframes only. The short-term model consisted of data for 11 months data pre and 20 months post vanguard. The long-term model consisted of data for 23 months pre and 34 months post vanguard. RESULTS: The cost consequences, including the cost of running the EHCH vanguard, were estimated using both a single tariff non-elective admissions methodology and a tariff per bed day methodology. The short-term model estimated a monthly cost increase of £73,408 using a single tariff methodology. When using a tariff per bed day, there was an estimated monthly cost increase of £14,315. The long-term model had, using a single tariff for non-elective admissions, an overall cost increase of £7576 per month. However, when using a tariff per bed-days, there was an estimated monthly cost reduction of £57,168. CONCLUSIONS: Although it is acknowledged that there is often a need for rapid evaluations in order to identify "quick wins" and to expedite learning within health and social care systems, we conclude that this may not be appropriate for quasi-experimental designs estimating effect using ITS for complex interventions. Our analyses suggests that care must be taken when conducting and interpreting the results of short-term evaluations using ITS methods, as they may produce misleading results and may lead to a misallocation of resources.

Estimating the effectiveness and cost-effectiveness of establishing additional endovascular Thrombectomy stroke Centres in England: a discrete event simulation.

BACKGROUND: We have previously modelled that the optimal number of comprehensive stroke centres (CSC) providing endovascular thrombectomy (EVT) in England would be 30 (net 6 new centres). We now estimate the relative effectiveness and cost-effectiveness of increasing the number of centres from 24 to 30. METHODS: We constructed a discrete event simulation (DES) to estimate the effectiveness and lifetime cost-effectiveness (from a payer perspective) using 1 year's incidence of stroke in England. 2000 iterations of the simulation were performed comparing baseline 24 centres to 30. RESULTS: Of 80,800 patients admitted to hospital with acute stroke/year, 21,740 would be affected by the service reconfiguration. The median time to treatment for eligible early presenters (< 270 min since onset) would reduce from 195 (IQR 155-249) to 165 (IQR 105-224) minutes. Our model predicts reconfiguration would mean an additional 33 independent patients (modified Rankin scale [mRS] 0-1) and 30 fewer dependent/dead patients (mRS 3-6) per year. The net addition of 6 centres generates 190 QALYs (95%CI - 6 to 399) and results in net savings to the healthcare system of £1,864,000/year (95% CI -1,204,000 to £5,017,000). The estimated budget impact was a saving of £980,000 in year 1 and £7.07 million in years 2 to 5. CONCLUSION: Changes in acute stroke service configuration will produce clinical and cost benefits when the time taken for patients to receive treatment is reduced. Benefits are highly likely to be cost saving over 5 years before any capital investment above £8 million is required.

Between a ROC and a hard place: Teaching prevalence plots to understand real world biomarker performance in the clinic.

The Receiver Operating Characteristic (ROC) curve and the Area Under the Curve (AUC) of the ROC curve are widely used in discovery to compare the performance of diagnostic and prognostic assays. The ROC curve has the advantage that it is independent of disease prevalence. However, in this note, we remind scientists and clinicians that the performance of an assay upon translation to the clinic is critically dependent upon that very same prevalence. Without an understanding of prevalence in the test population, even robust bioassays with excellent ROC characteristics may perform poorly in the clinic. While the exact prevalence in the target population is not always known, simple plots of candidate assay performance as a function of prevalence rate give a better understanding of the likely real-world performance and a greater understanding of the likely impact of variation in that prevalence on translation to the clinic.

A Delphi study and ranking exercise to support commissioning services: future delivery of Thrombectomy services in England.

BACKGROUND: Intra-arterial thrombectomy is the gold standard treatment for large artery occlusive stroke. However, the evidence of its benefits is almost entirely based on trials delivered by experienced neurointerventionists working in established teams in neuroscience centres. Those responsible for the design and prospective reconfiguration of services need access to a comprehensive and complementary array of information on which to base their decisions. This will help to ensure the demonstrated effects from trials may be realised in practice and account for regional/local variations in resources and skill-sets. One approach to elucidate the implementation preferences and considerations of key experts is a Delphi survey. In order to support commissioning decisions, we aimed using an electronic Delphi survey to establish consensus on the options for future organisation of thrombectomy services among physicians with clinical experience in managing large artery occlusive stroke. METHODS: A Delphi survey was developed with 12 options for future organisation of thrombectomy services in England. A purposive sampling strategy established an expert panel of stroke physicians from the British Association of Stroke Physicians (BASP) Clinical Standards and/or Executive Membership that deliver 24/7 intravenous thrombolysis. Options with aggregate scores falling within the lowest quartile were removed from the subsequent Delphi round. Options reaching consensus following the two Delphi rounds were then ranked in a final exercise by both the wider BASP membership and the British Society of Neuroradiologists (BSNR). RESULTS: Eleven stroke physicians from BASP completed the initial two Delphi rounds. Three options achieved consensus, with subsequently wider BASP (97%, n = 43) and BSNR members (86%, n = 21) assigning the highest approval rankings in the final exercise for transferring large artery occlusive stroke patients to nearest neuroscience centre for thrombectomy based on local CT/CT Angiography. CONCLUSIONS: The initial Delphi rounds ensured optimal reduction of options by an expert panel of stroke physicians, while subsequent ranking exercises allowed remaining options to be ranked by a wider group of experts within stroke to reach consensus. The preferred implementation option for thrombectomy is investigating suspected acute stroke patients by CT/CT Angiography and secondary transfer of large artery occlusive stroke patients to the nearest neuroscience (thrombectomy) centre.

Can Automated Imaging for Optic Disc and Retinal Nerve Fiber Layer Analysis Aid Glaucoma Detection?

PURPOSE: To compare the diagnostic performance of automated imaging for glaucoma. DESIGN: Prospective, direct comparison study. PARTICIPANTS: Adults with suspected glaucoma or ocular hypertension referred to hospital eye services in the United Kingdom. METHODS: We evaluated 4 automated imaging test algorithms: the Heidelberg Retinal Tomography (HRT; Heidelberg Engineering, Heidelberg, Germany) glaucoma probability score (GPS), the HRT Moorfields regression analysis (MRA), scanning laser polarimetry (GDx enhanced corneal compensation; Glaucoma Diagnostics (GDx), Carl Zeiss Meditec, Dublin, CA) nerve fiber indicator (NFI), and Spectralis optical coherence tomography (OCT; Heidelberg Engineering) retinal nerve fiber layer (RNFL) classification. We defined abnormal tests as an automated classification of outside normal limits for HRT and OCT or NFI ≥ 56 (GDx). We conducted a sensitivity analysis, using borderline abnormal image classifications. The reference standard was clinical diagnosis by a masked glaucoma expert including standardized clinical assessment and automated perimetry. We analyzed 1 eye per patient (the one with more advanced disease). We also evaluated the performance according to severity and using a combination of 2 technologies. MAIN OUTCOME MEASURES: Sensitivity and specificity, likelihood ratios, diagnostic, odds ratio, and proportion of indeterminate tests. RESULTS: We recruited 955 participants, and 943 were included in the analysis. The average age was 60.5 years (standard deviation, 13.8 years); 51.1% were women. Glaucoma was diagnosed in at least 1 eye in 16.8%; 32% of participants had no glaucoma-related findings. The HRT MRA had the highest sensitivity (87.0%; 95% confidence interval [CI], 80.2%-92.1%), but lowest specificity (63.9%; 95% CI, 60.2%-67.4%); GDx had the lowest sensitivity (35.1%; 95% CI, 27.0%-43.8%), but the highest specificity (97.2%; 95% CI, 95.6%-98.3%). The HRT GPS sensitivity was 81.5% (95% CI, 73.9%-87.6%), and specificity was 67.7% (95% CI, 64.2%-71.2%); OCT sensitivity was 76.9% (95% CI, 69.2%-83.4%), and specificity was 78.5% (95% CI, 75.4%-81.4%). Including only eyes with severe glaucoma, sensitivity increased: HRT MRA, HRT GPS, and OCT would miss 5% of eyes, and GDx would miss 21% of eyes. A combination of 2 different tests did not improve the accuracy substantially. CONCLUSIONS: Automated imaging technologies can aid clinicians in diagnosing glaucoma, but may not replace current strategies because they can miss some cases of severe glaucoma.

Relative distributions: a novel method for examining trends between stroke onset and thrombolysis time.

BACKGROUND AND PURPOSE: Analyses of trends in the delivery of time critical treatments typically report the median, but measures of central tendency may ignore important changes for specific patient groups. We considered whether this was an important effect during comparison of onset to treatment (OTT) time between 2 cohorts of patients with stroke receiving intravenous thrombolysis. METHODS: After controlling for stroke severity, a relative distributions technique compared OTT for UK patients treated with recombinant tissue-type plasminogen activator registered within the first and last quarters (each n=661) of the Safe Implementation of Thrombolysis in Stroke-Monitoring Study database between January 2003 and September 2010. RESULTS: Significant differences were found between OTT distributions. Overall, the second cohort's OTT distribution demonstrated simultaneous increases in the proportion of patients with faster and slower OTT, which resulted in no net effect on the median after correction for stroke severity. CONCLUSIONS: Medians did not adequately describe distributional changes. Faster OTT may be because of more efficient processes in acute stroke centers and improved symptom recognition by the public. Slower OTT is likely to reflect movement from a 3- to a 4.5-hour OTT target. Relative distributions offer new insights into historical trends and service evaluation where time critical treatments are involved.