Risk Adjustment In Neurocritical care (RAIN)--prospective validation of risk prediction models for adult patients with acute traumatic brain injury to use to evaluate the optimum location and comparative costs of neurocritical care: a cohort study.

OBJECTIVES: To validate risk prediction models for acute traumatic brain injury (TBI) and to use the best model to evaluate the optimum location and comparative costs of neurocritical care in the NHS. DESIGN: Cohort study. SETTING: Sixty-seven adult critical care units. PARTICIPANTS: Adult patients admitted to critical care following actual/suspected TBI with a Glasgow Coma Scale (GCS) score of < 15. INTERVENTIONS: Critical care delivered in a dedicated neurocritical care unit, a combined neuro/general critical care unit within a neuroscience centre or a general critical care unit outside a neuroscience centre. MAIN OUTCOME MEASURES: Mortality, Glasgow Outcome Scale - Extended (GOSE) questionnaire and European Quality of Life-5 Dimensions, 3-level version (EQ-5D-3L) questionnaire at 6 months following TBI. RESULTS: The final Risk Adjustment In Neurocritical care (RAIN) study data set contained 3626 admissions. After exclusions, 3210 patients with acute TBI were included. Overall follow-up rate at 6 months was 81%. Of 3210 patients, 101 (3.1%) had no GCS score recorded and 134 (4.2%) had a last pre-sedation GCS score of 15, resulting in 2975 patients for analysis. The most common causes of TBI were road traffic accidents (RTAs) (33%), falls (47%) and assault (12%). Patients were predominantly young (mean age 45 years overall) and male (76% overall). Six-month mortality was 22% for RTAs, 32% for falls and 17% for assault. Of survivors at 6 months with a known GOSE category, 44% had severe disability, 30% moderate disability and 26% made a good recovery. Overall, 61% of patients with known outcome had an unfavourable outcome (death or severe disability) at 6 months. Between 35% and 70% of survivors reported problems across the five domains of the EQ-5D-3L. Of the 10 risk models selected for validation, the best discrimination overall was from the International Mission for Prognosis and Analysis of Clinical Trials in TBI Lab model (IMPACT) (c-index 0.779 for mortality, 0.713 for unfavourable outcome). The model was well calibrated for 6-month mortality but substantially underpredicted the risk of unfavourable outcome at 6 months. Baseline patient characteristics were similar between dedicated neurocritical care units and combined neuro/general critical care units. In lifetime cost-effectiveness analysis, dedicated neurocritical care units had higher mean lifetime quality-adjusted life-years (QALYs) at small additional mean costs with an incremental cost-effectiveness ratio (ICER) of £14,000 per QALY and incremental net monetary benefit (INB) of £17,000. The cost-effectiveness acceptability curve suggested that the probability that dedicated compared with combined neurocritical care units are cost-effective is around 60%. There were substantial differences in case mix between the 'early' (within 18 hours of presentation) and 'no or late' (after 24 hours) transfer groups. After adjustment, the 'early' transfer group reported higher lifetime QALYs at an additional cost with an ICER of £11,000 and INB of £17,000. CONCLUSIONS: The risk models demonstrated sufficient statistical performance to support their use in research but fell below the level required to guide individual patient decision-making. The results suggest that management in a dedicated neurocritical care unit may be cost-effective compared with a combined neuro/general critical care unit (although there is considerable statistical uncertainty) and support current recommendations that all patients with severe TBI would benefit from transfer to a neurosciences centre, regardless of the need for surgery. We recommend further research to improve risk prediction models; consider alternative approaches for handling unobserved confounding; better understand long-term outcomes and alternative pathways of care; and explore equity of access to postcritical care support for patients following acute TBI. FUNDING: The National Institute for Health Research Health Technology Assessment programme

Scope And Outcomes Of A Trauma Quality Improvement Program At Royal Prince Alfred Hospital, Australia 2006-2016

Background Injury and trauma remain important causes of morbidity and mortality globally. Trauma systems have been established to facilitate optimal management of injured patients, including timely access to specialist trauma centres in those who are severely injured. Trauma quality improvement programs have emerged over the past decade to evaluate and improve quality of care delivered by trauma systems and trauma centres. Despite this, there remains little evidence to demonstrate that these quality improvement programs actually improve patient outcomes or whether they are cost-effective. In 2006, a trauma quality improvement program was initiated at Royal Prince Alfred Hospital, Australia. This consisted primarily of the implementation of trauma team activation and resuscitation protocols, and the evaluation of care through the use of clinical indicators (key performance indicators) and measurement of post discharge health status. Objectives This thesis describes a quality improvement program at Royal Prince Alfred Hospital that involved monitoring of all major clinical services involved in the acute care of trauma at this hospital, and evaluates this program with respect to in-patient mortality for severe injury, cost effectiveness and long term outcomes. Methods The studies were conducted at Royal Prince Alfred Hospital (RPA) in New South Wales Australia. The thesis is presented in four main sections. The first section (chapters 1 to 4) provides an outline of the thesis and summarises the current literature on trauma quality improvement programs. Preliminary papers describe the historical context of the trauma service at this institution and discuss the conceptual framework for trauma patient data collection. The second section (chapters 5 to 9) provides background information regarding contemporaneous trends in injury presentations to Emergency Departments and major trauma activity and mortality across NSW. The third section (chapters 10 to 13) details and evaluates the impact of the trauma quality improvement program on long-term major trauma mortality trends at this hospital using time series analysis and its cost effectiveness in a subset of road trauma patients. It also investigates health status outcomes in trauma patients at three and six months after hospital discharge - a project initiated as part of the quality improvement program. Results Injury is one of the leading causes of presentations to Emergency Departments across NSW and the critically injured make up around 1% of total injury presentations. Major trauma in-hospital mortality across NSW has remained stable at around 16% between 2003 and 2014. The trauma quality improvement program at RPA was associated with a significant reduction in major trauma mortality from 16% to 10% after 2007. The incremental cost effectiveness was estimated to be $7600 per year of life saved in the subset of road trauma patients. Analyses of health outcomes after discharge revealed increasing injury severity and upper limb injuries were the only predictors of reduced employment status after injury, and lower limb injuries were associated with reduced physical health status compared to those without lower limb injuries at both 3 and 6 months post discharge. Around 37% of patients reported signs of psychological distress and this did not change significantly during the study interval. Conclusions This thesis has published important new information regarding the clinical and cost-effectiveness of trauma quality improvement programs. It contains the first published studies evaluating these interventions using formal time series and health economics analysis and one of few reporting the intervention in the context of existing injury and trauma management systems in New South Wales Australia

Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT

Background: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. Primary objective: Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). Design: A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element). Setting: The trial was set in 42 secondary and community inpatient facilities in the UK. Participants: Adult inpatients with evidence of acute illness and at a high risk of PU development. Interventions and follow-up: APM or HSFM – the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up. Main outcome measures: Time to event. Results: From August 2013 to November 2016, 2029 participants were randomised to receive either APM (n = 1016) or HSFM (n = 1013). Primary end point – 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact p-value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93; p = 0.0176 and 2.6% absolute difference). Secondary end points – 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; p-value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62; p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed – there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68; p = 0.6122 and absolute difference 2.9%). Health economics – the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy – the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was ‘very good’ (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy – the Pressure Ulcer Quality of Life – Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. Limitations: A lower than anticipated event rate. Conclusions: In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. Future work: Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore ‘what works for whom and in what circumstances’. Trial registration: Current Controlled Trials ISRCTN01151335. Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 52. See the NIHR Journals Library website for further project information

A national registry to assess the value of cardiovascular magnetic resonance imaging after primary percutaneous coronary intervention pathway activation:a feasibility cohort study

Background Cardiovascular magnetic resonance (CMR) is increasingly used in patients who activate the primary percutaneous coronary intervention (PPCI) pathway to assess heart function. It is uncertain whether having CMR influences patient management or the risk of major adverse cardiovascular events in these patients. Objective To determine whether or not it is feasible to set up a national registry, linking routinely collected data from hospital information systems (HISs), to investigate the role of CMR in patients who activate the PPCI pathway. Design A feasibility prospective cohort study. Setting Four 24/7 PPCI hospitals in England and Wales (two with and two without a dedicated CMR facility). Participants Patients who activated the PPCI pathway and underwent an emergency coronary angiogram. Interventions CMR either performed or not performed within 10 weeks of the index event. Main outcome measures A. Feasibility parameters – (1) patient consent implemented at all hospitals, (2) data extracted from more than one HIS and successfully linked for andgt; 90% of consented patients at all four hospitals, (3) HIS data successfully linked with Hospital Episode Statistics (HES) and Patient Episode Database Wales (PEDW) for andgt; 90% of consented patients at all four hospitals and (4) CMR requested and carried out for ≥ 10% of patients activating the PPCI pathway in CMR hospitals. B. Key drivers of cost-effectiveness for CMR (identified from simple cost-effectiveness models) in patients with (1) multivessel disease and (2) unobstructed coronary arteries. C. A change in clinical management arising from having CMR (defined using formal consensus and identified using HES follow-up data in the 12 months after the index event). Results A. (1) Consent was implemented (for all hospitals, consent rates were 59–74%) and 1670 participants were recruited. (2) Data submission was variable – clinical data available for ≥ 82% of patients across all hospitals, biochemistry and echocardiography (ECHO) data available for ≥ 98%, 34% and 87% of patients in three hospitals and medications data available for 97% of patients in one hospital. (3) HIS data were linked with hospital episode data for 99% of all consented patients. (4) At the two CMR hospitals, 14% and 20% of patients received CMR. B. In both (1) multivessel disease and (2) unobstructed coronary arteries, the difference in quality-adjusted life-years (QALYs) between CMR and no CMR [‘current’ comparator, stress ECHO and standard ECHO, respectively] was very small [0.0012, 95% confidence interval (CI) –0.0076 to 0.0093 and 0.0005, 95% CI –0.0050 to 0.0077, respectively]. The diagnostic accuracy of the ischaemia tests was the key driver of cost-effectiveness in sensitivity analyses for both patient subgroups. C. There was consensus that CMR leads to clinically important changes in management in five patient subgroups. Some changes in management were successfully identified in hospital episode data (e.g. new diagnoses/procedures, frequency of outpatient episodes related to cardiac events), others were not (e.g. changes in medications, new diagnostic tests). Conclusions A national registry is not currently feasible. Patients were consented successfully but conventional consent could not be implemented nationally. Linking HIS and hospital episode data was feasible but HIS data were not uniformly available. It is feasible to identify some, but not all, changes in management in the five patient subgroups using hospital episode data. The delay in obtaining hospital episode data influenced the relevance of some of our study objectives. Future work To test the feasibility of conducting the study using national data sets (e.g. HES, British Cardiovascular Intervention Society audit database, Diagnostic Imaging Dataset, Clinical Practice Research Datalink). Funding The National Institute for Health Research (NIHR) Health Services and Delivery Research programme. This study was designed and delivered in collaboration with the Clinical Trials and Evaluation Unit, a UK Clinical Research Collaboration-registered clinical trials unit that, as part of the Bristol Trials Centre, is in receipt of NIHR clinical trials unit support funding. </jats:sec

Community hospitals and their services in the NHS: identifying transferable learning from international developments – scoping review, systematic review, country reports and case studies

Background The notion of a community hospital in England is evolving from the traditional model of a local hospital staffed by general practitioners and nurses and serving mainly rural populations. Along with the diversification of models, there is a renewed policy interest in community hospitals and their potential to deliver integrated care. However, there is a need to better understand the role of different models of community hospitals within the wider health economy and an opportunity to learn from experiences of other countries to inform this potential. Objectives This study sought to (1) define the nature and scope of service provision models that fit under the umbrella term ‘community hospital’ in the UK and other high-income countries, (2) analyse evidence of their effectiveness and efficiency, (3) explore the wider role and impact of community engagement in community hospitals, (4) understand how models in other countries operate and asses their role within the wider health-care system, and (5) identify the potential for community hospitals to perform an integrative role in the delivery of health and social care. Methods A multimethod study including a scoping review of community hospital models, a linked systematic review of their effectiveness and efficiency, an analysis of experiences in Australia, Finland, Italy, Norway and Scotland, and case studies of four community hospitals in Finland, Italy and Scotland. Results The evidence reviews found that community hospitals provide a diverse range of services, spanning primary, secondary and long-term care in geographical and health system contexts. They can offer an effective and efficient alternative to acute hospitals. Patient experience was frequently reported to be better at community hospitals, and the cost-effectiveness of some models was found to be similar to that of general hospitals, although evidence was limited. Evidence from other countries showed that community hospitals provide a wide spectrum of health services that lie on a continuum between serving a ‘geographic purpose’ and having a specific population focus, mainly older people. Structures continue to evolve as countries embark on major reforms to integrate health and social care. Case studies highlighted that it is important to consider local and national contexts when looking at how to transfer models across settings, how to overcome barriers to integration beyond location and how the community should be best represented. Limitations The use of a restricted definition may have excluded some relevant community hospital models, and the small number of countries and case studies included for comparison may limit the transferability of findings for England. Although this research provides detailed insights into community hospitals in five countries, it was not in its scope to include the perspective of patients in any depth. Conclusions At a time when emphasis is being placed on integrated and community-based care, community hospitals have the potential to assume a more strategic role in health-care delivery locally, providing care closer to people’s homes. There is a need for more research into the effectiveness and cost-effectiveness of community hospitals, the role of the community and optimal staff profile(s). Funding The National Institute for Health Research Health Services and Delivery Research programme

Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair : a systematic review and economic evaluation

Study registration: This study is registered as PROSPERO CRD42016036475. Funding: The National Institute for Health Research Health Technology Assessment programme.Peer reviewedPublisher PD

Evaluating alcohol intoxication management services: the EDARA mixed-methods study

Background: Front-line health-care services are under increased demand when acute alcohol intoxication is most common, which is in night-time environments. Cities have implemented alcohol intoxication management services to divert the intoxicated away from emergency care. Objectives: To evaluate the effectiveness, cost-effectiveness and acceptability to patients and staff of alcohol intoxication management services and undertake an ethnographic study capturing front-line staff’s views on the impact of acute alcohol intoxication on their professional lives. Methods: This was a controlled mixed-methods longitudinal observational study with an ethnographic evaluation in parallel. Six cities with alcohol intoxication management services were compared with six matched control cities to determine effects on key performance indicators (e.g. number of patients in the emergency department and ambulance response times). Surveys captured the impact of alcohol intoxication management services on the quality of care for patients in six alcohol intoxication management services, six emergency departments with local alcohol intoxication management services and six emergency departments without local alcohol intoxication management services. The ethnographic study considered front-line staff perceptions in two cities with alcohol intoxication management services and one city without alcohol intoxication management services. Results: Alcohol intoxication management services typically operated in cities in which the incidence of acute alcohol intoxication was greatest. The per-session average number of attendances across all alcohol intoxication management services was low (mean 7.3, average minimum 2.8, average maximum 11.8) compared with the average number of emergency department attendances per alcohol intoxication management services session (mean 78.8), and the number of patients diverted away from emergency departments, per session, required for services to be considered cost-neutral was 8.7, falling to 3.5 when ambulance costs were included. Alcohol intoxication management services varied, from volunteer-led first aid to more clinically focused nurse practitioner services, with only the latter providing evidence for diversion from emergency departments. Qualitative and ethnographic data indicated that alcohol intoxication management services are acceptable to practitioners and patients and that they address unmet need. There was evidence that alcohol intoxication management services improve ambulance response times and reduce emergency department attendance. Effects are uncertain owing to the variation in service delivery. Limitations: The evaluation focused on health service outcomes, yet evidence arose suggesting that alcohol intoxication management services provide broader societal benefits. There was no nationally agreed standard operating procedure for alcohol intoxication management services, undermining the evaluation. Routine health data outcomes exhibited considerable variance, undermining opportunities to provide an accurate appraisal of the heterogenous collection of alcohol intoxication management services. Conclusions: Alcohol intoxication management services are varied, multipartner endeavours and would benefit from agreed national standards. Alcohol intoxication management services are popular with and benefit front-line staff and serve as a hub facilitating partnership working. They are popular with alcohol intoxication management services patients and capture previously unmet need in night-time environments. However, acute alcohol intoxication in emergency departments remains an issue and opportunities for diversion have not been entirely realised. The nurse-led model was the most expensive service evaluated but was also the most likely to divert patients away from emergency departments, suggesting that greater clinical involvement and alignment with emergency departments is necessary. Alcohol intoxication management services should be regarded as fledgling services that require further work to realise benefit. Future work: Research could be undertaken to determine if a standardised model of alcohol intoxication management services, based on the nurse practitioner model, can be developed and implemented in different settings. Future evaluations should go beyond the health service and consider outcomes more generally, especially for the police. Future work on the management of acute alcohol intoxication in night-time environments could recognise the partnership between health-care, police and ambulance services and third-sector organisations in managing acute alcohol intoxication. Trial registration: Current Controlled Trials ISRCTN63096364

Post Hepatectomy Liver Failure: Risk Factors and Prediction of Post-Operative Function using Novel Dynamic MRI

Liver surgery is an advancing specialty with improved outcomes in recent years. Liver resection is used with curative intent for both primary and metastatic cancer. Despite the rapid improvements and increasing range of surgical options, there remains a significant risk of developing Post-Hepatectomy Liver Failure (PHLF) – caused by inadequate remnant liver function after surgery. This is a condition with high mortality and morbidity and currently there are no specific treatments for it once it has developed. Its pathogenesis is complex and multifactorial, and some risk factors, particularly ageing are uncertain as to their contributing significance. This thesis aimed to investigate risk factors for PHLF development and a imaging based measurement of liver function after major liver resection. This study identified patients over-75 years have a significantly increased risk of PHLF. Development of a method to predict post-operative function is needed to aid patient selection and reduce complications for those who undergo resection. Currently, volumetry is performed but this has proven inadequate, with some patients still developing PHLF despite adequate remnant volume. Other options such as Indocyanine Green and Technetium-99m labelled Mebrofenin are not readily available. One potential solution is Dynamic Gadoxetate Enhanced (DGE) MRI of the Liver, which has been developed to investigate liver function, with promising results for demonstrating liver heterogenicity in patients with parenchymal liver diseases. Oncological staging of the liver involves MRI to plan surgical resection, and DGE-MRI can be integrated into the diagnostic protocol easily with no additional burden to the patient. This thesis aimed to demonstrate if DGE-MRI functional estimates can predict post-operative liver function after resection of colorectal liver metastases. This study demonstrated that there was good correlation of DGE-MRI-function tests with post-operative hyperbilirubinaemia, a measure of hepatic dysfunction. This could be utilised in surgical planning to improve patient selection and outcomes

Electronic health records in ambulances: the ERA multiple-methods study

Background: Ambulance services have a vital role in the shift towards the delivery of health care outside hospitals, when this is better for patients, by offering alternatives to transfer to the emergency department. The introduction of information technology in ambulance services to electronically capture, interpret, store and transfer patient data can support out-of-hospital care. Objective: We aimed to understand how electronic health records can be most effectively implemented in a pre-hospital context in order to support a safe and effective shift from acute to community-based care, and how their potential benefits can be maximised. Design and setting: We carried out a study using multiple methods and with four work packages: (1) a rapid literature review; (2) a telephone survey of all 13 freestanding UK ambulance services; (3) detailed case studies examining electronic health record use through qualitative methods and analysis of routine data in four selected sites consisting of UK ambulance services and their associated health economies; and (4) a knowledge-sharing workshop. Results: We found limited literature on electronic health records. Only half of the UK ambulance services had electronic health records in use at the time of data collection, with considerable variation in hardware and software and some reversion to use of paper records as services transitioned between systems. The case studies found that the ambulance services’ electronic health records were in a state of change. Not all patient contacts resulted in the generation of electronic health records. Ambulance clinicians were dealing with partial or unclear information, which may not fit comfortably with the electronic health records. Ambulance clinicians continued to use indirect data input approaches (such as first writing on a glove) even when using electronic health records. The primary function of electronic health records in all services seemed to be as a store for patient data. There was, as yet, limited evidence of electronic health records’ full potential being realised to transfer information, support decision-making or change patient care. Limitations: Limitations included the difficulty of obtaining sets of matching routine data for analysis, difficulties of attributing any change in practice to electronic health records within a complex system and the rapidly changing environment, which means that some of our observations may no longer reflect reality. Conclusions: Realising all the benefits of electronic health records requires engagement with other parts of the local health economy and dealing with variations between providers and the challenges of interoperability. Clinicians and data managers, and those working in different parts of the health economy, are likely to want very different things from a data set and need to be presented with only the information that they need