Primary and secondary care service use and costs associated with frailty in an ageing population: longitudinal analysis of an English primary care cohort of adults aged 50 and over, 2006-2017.

BACKGROUND: Frailty becomes more prevalent and healthcare needs increase with age. Information on the impact of frailty on population level use of health services and associated costs is needed to plan for ageing populations. AIM: To describe primary and secondary care service use and associated costs by electronic Frailty Index (eFI) category. DESIGN AND SETTING: Retrospective cohort using electronic health records. Participants aged ≥50 registered in primary care practices contributing to the Oxford Royal College of General Practitioners Research and Surveillance Centre, 2006-2017. METHODS: Primary and secondary care use (totals and means) were stratified by eFI category and age group. Standardised 2017 costs were used to calculate primary, secondary and overall costs. Generalised linear models explored associations between frailty, sociodemographic characteristics. Adjusted mean costs and cost ratios were produced. RESULTS: Individual mean annual use of primary and secondary care services increased with increasing frailty severity. Overall cohort care costs for were highest in mild frailty in all 12 years, followed by moderate and severe, although the proportion of the population with severe frailty can be expected to increase over time. After adjusting for sociodemographic factors, compared to the fit category, individual annual costs doubled in mild frailty, tripled in moderate and quadrupled in severe. CONCLUSIONS: Increasing levels of frailty are associated with an additional burden of individual service use. However, individuals with mild and moderate frailty contribute to higher overall costs. Earlier intervention may have the most potential to reduce service use and costs at population level.

Frailty transitions and prevalence in an ageing population: longitudinal analysis of primary care data from an open cohort of adults aged 50 and over in England, 2006-2017.

INTRODUCTION: frailty is common in older adults and is associated with increased health and social care use. Longitudinal information is needed on population-level incidence, prevalence and frailty progression to plan services to meet future population needs. METHODS: retrospective open cohort study using electronic health records of adults aged ≥50 from primary care in England, 2006-2017. Frailty was calculated annually using the electronic Frailty Index (eFI). Multistate models estimated transition rates between each frailty category, adjusting for sociodemographic characteristics. Prevalence overall for each eFI category (fit, mild, moderate and severe) was calculated. RESULTS: the cohort included 2,171,497 patients and 15,514,734 person-years. Frailty prevalence increased from 26.5 (2006) to 38.9% (2017). The average age of frailty onset was 69; however, 10.8% of people aged 50-64 were already frail in 2006. Estimated transitions from fit to any level of frailty were 48/1,000 person-years aged 50-64, 130/1,000 person-years aged 65-74, 214/1,000 person-years aged 75-84 and 380/1,000 person-years aged ≥ 85. Transitions were independently associated with older age, higher deprivation, female sex, Asian ethnicity and urban dwelling. Mean time spent in each frailty category decreased with age, with the longest period spent in severe frailty at all ages. CONCLUSIONS: frailty is prevalent in adults aged ≥50 and time spent in successive frailty states is longer as frailty progresses, resulting in extended healthcare burden. Larger population numbers and fewer transitions in adults aged 50-64 present an opportunity for earlier identification and intervention. A large increase in frailty over 12 years highlights the urgency of informed service planning in ageing populations.

Randomized controlled trial of EndoRings assisted colonoscopy versus standard colonoscopy.

OBJECTIVES: The EndoRings device is a distal attachment consisting of two layers of circular flexible rings that evert mucosal folds. The aim of this study was to investigate whether EndoRing assisted colonoscopy (ER) improves polyp and adenoma detection compared to standard colonoscopy (SC). METHODS: Multicenter, parallel group, randomized controlled trial. RESULTS: Total of 556 patients randomized to ER (n = 275) or SC (n = 281). Colonoscopy completed in 532/556 (96%) cases. EndoRings removed in 74/275 (27%) patients. Total number of polyps in ER limb 582 vs. 515 in SC limb, P = 0.04. Total number of adenomas in ER limb 361 vs. 343 for SC limb, P = 0.49. A statistically significant difference in the mean number of polyps per patient in both the intention to treat (1.84 SC vs. 2.10 ER, P = 0.027) and per protocol (PP) (1.84 SC vs. 2.25 ER, P = 0.004). CONCLUSIONS: Our study shows promise for the EndoRings device to improve polyp detection.

The dynamics of frailty development and progression in older adults in primary care in England (2006-2017): a retrospective cohort profile.

BACKGROUND: Frailty is a common condition in older adults and has a major impact on patient outcomes and service use. Information on the prevalence in middle-aged adults and the patterns of progression of frailty at an individual and population level is scarce. To address this, a cohort was defined from a large primary care database in England to describe the epidemiology of frailty and understand the dynamics of frailty within individuals and across the population. This article describes the structure of the dataset, cohort characteristics and planned analyses. METHODS: Retrospective cohort study using electronic health records. Participants were aged ≥50 years registered in practices contributing to the Oxford Royal College of General Practitioners Research and Surveillance Centre between 2006 to 2017. Data include GP practice details, patient sociodemographic and clinical characteristics, twice-yearly electronic Frailty Index (eFI), deaths, medication use and primary and secondary care health service use. Participants in each cohort year by age group, GP and patient characteristics at cohort entry are described. RESULTS: The cohort includes 2,177,656 patients, contributing 15,552,946 person-years, registered at 419 primary care practices in England. The mean age was 61 years, 52.1% of the cohort was female, and 77.6% lived in urban environments. Frailty increased with age, affecting 10% of adults aged 50-64 and 43.7% of adults aged ≥65. The prevalence of long-term conditions and specific frailty deficits increased with age, as did the eFI and the severity of frailty categories. CONCLUSION: A comprehensive understanding of frailty dynamics will inform predictions of current and future care needs to facilitate timely planning of appropriate interventions, service configurations and workforce requirements. Analysis of this large, nationally representative cohort including participants aged ≥50 will capture earlier transitions to frailty and enable a detailed understanding of progression and impact. These results will inform novel simulation models which predict future health and service needs of older people living with frailty. STUDY REGISTRATION: Registered on www.clinicaltrials.gov October 25th 2019, NCT04139278 .

Improving recording and reporting of dementia and frailty via electronic patient record by ambulance staff in a single service (IDEAS).

BACKGROUND: Dementia is common in older adults assessed by ambulance services. However, inconsistent reporting via the patient record may result in this diagnosis being overlooked by healthcare staff further down the care pathway. This can have a deleterious effect on subsequent patient care, increasing morbidity and mortality. We sought to understand how and where ambulance staff would like to record this finding on the electronic patient record (ePR). METHODS: We designed and implemented a survey of ambulance staff in a single service to understand how they identify patients with dementia, how they record dementia on the ePR and how the ePR could be improved to better capture dementia. Scoping questions on frailty were included. The survey was tested using cognitive interviewing. Analysis was conducted using descriptive statistics for closed questions and thematic analysis for open questions as appropriate. RESULTS: 131 surveys were completed; 60% of participants were paramedics and 40% were other grades of front line staff. Participants reported consulting electronic/paper sources, and individuals such as carers involved in the patients' care, to establish whether dementia had been diagnosed. Frailty assessments were prompted by social context, reduced mobility, a fall or diagnosis of dementia. Staff reported documenting dementia in 20 different areas on the ePR and 46% of participants stated a preference for a designated area to record the information. However, 15% indicated it was not necessary to record dementia or that no ePR changes were required. CONCLUSIONS: We have highlighted the variation in ambulance staff practice in recording of dementia. Alterations to the ePR are required to ensure that dementia is recorded consistently and is easily retrievable. Clearer guidance on when to assess frailty may also enhance information provision to care staff in other sectors, resulting in more appropriate clinical and social care.

Reducing ambulance conveyance for older people with and without dementia: evidence of the role of social care from a regional, year-long service evaluation using retrospective routine data.

INTRODUCTION: Older people, especially those with dementia, have a high risk of deterioration following admission to hospital. More than 60% of older people attended by South Central Ambulance Service (SCAS) clinicians are conveyed to hospital, although many conveyances may not have been due to life-threatening conditions. We aimed to understand patterns of conveyance and alternative referral pathways used following ambulance attendance to an older person. METHODS: Service evaluation, using routinely collected, anonymised electronic records. PARTICIPANTS: Electronic records of people aged ≥75 years for whom an ambulance was dispatched between April 2016 and March 2017 within the geographical boundaries of SCAS NHS Foundation Trust, who were alive on arrival of the ambulance. Conveyance rates are described according to patient and emergency-call characteristics. Logistic regression was used to produce adjusted odds ratios for conveyance. Alternative referral pathways used are described. RESULTS: Of 110,781 patients attended, 64% were conveyed to hospital. Factors associated with reduced odds of conveyance included out-of-hours calls (adjusted odds ratio (aOR) 0.82 [0.79-0.85]), living alone with a care package or with family plus care package (aOR 0.66 [0.62-0.69]; aOR 0.58 [0.54-0.62] respectively) and a record of dementia (0.91 [0.87-0.96]). Living in a nursing home was associated with an increased risk of conveyance (aOR 1.25 [1.15-1.36]). Patients with dementia with more income were significantly less likely to be conveyed than those with less income. Alternative referral services were used in 22% of non-conveyed patients, most commonly GP, out-of-hours and falls services. DISCUSSION: People aged ≥75 years have high rates of conveyance, which are influenced by factors such as out-of-hours calls, dementia and receipt of social care. Low use of alternative referral services may reflect limited availability or difficulty in access. A better understanding of how these factors influence ambulance clinician decision-making is integral to improvement of outcomes for older people.

Developing the Accuracy of Vital Sign Measurements Using the Lifelight Software Application in Comparison to Standard of Care Methods: Observational Study Protocol.

BACKGROUND: Vital sign measurements are an integral component of clinical care, but current challenges with the accuracy and timeliness of patient observations can impact appropriate clinical decision making. Advanced technologies using techniques such as photoplethysmography have the potential to automate noncontact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information. OBJECTIVE: In this study, we aim to develop the algorithm used in the Lifelight software application and improve the accuracy of its estimated heart rate, respiratory rate, oxygen saturation, and blood pressure measurements. METHODS: This preliminary study will compare measurements predicted by the Lifelight software with standard of care measurements for an estimated population sample of 2000 inpatients, outpatients, and healthy people attending a large acute hospital. Both training datasets and validation datasets will be analyzed to assess the degree of correspondence between the vital sign measurements predicted by the Lifelight software and the direct physiological measurements taken using standard of care methods. Subgroup analyses will explore how the performance of the algorithm varies with particular patient characteristics, including age, sex, health condition, and medication. RESULTS: Recruitment of participants to this study began in July 2018, and data collection will continue for a planned study period of 12 months. CONCLUSIONS: Digital health technology is a rapidly evolving area for health and social care. Following this initial exploratory study to develop and refine the Lifelight software application, subsequent work will evaluate its performance across a range of health characteristics, and extended validation trials will support its pathway to registration as a medical device. Innovations in health technology such as this may provide valuable opportunities for increasing the efficiency and accessibility of vital sign measurements and improve health care services on a large scale across multiple health and care settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14326.

Predicting survival in malignant pleural mesothelioma using routine clinical and laboratory characteristics.

INTRODUCTION: The prognosis of malignant pleural mesothelioma (MPM) is poor, with a median survival of 8-12 months. The ability to predict prognosis in MPM would help clinicians to make informed decisions regarding treatment and identify appropriate research opportunities for patients. The aims of this study were to examine associations between clinical and pathological information gathered during routine care, and prognosis of patients with MPM, and to develop a 6-month mortality risk prediction model. METHODS: A retrospective cohort study of patients diagnosed with MPM at Queen Alexandra Hospital, Portsmouth, UK between December 2009 and September 2013. Multivariate analysis was performed on routinely available histological, clinical and laboratory data to assess the association between different factors and 6-month survival, with significant associations used to create a model to predict the risk of death within 6 months of diagnosis with MPM. RESULTS: 100 patients were included in the analysis. Variables significantly associated with patient survival in multivariate analysis were age (HR 1.31, 95% CI 1.09 to 1.56), smoking status (current smoker HR 3.42, 95% CI 1.11 to 4.20), chest pain (HR 2.14, 95% CI 1.23 to 3.72), weight loss (HR 2.13, 95% CI 1.18 to 3.72), platelet count (HR 1.05, 95% CI 1.00 to 1.10), urea (HR 2.73, 95% CI 1.31 to 5.69) and adjusted calcium (HR 1.47, 95% CI 1.10 to 1.94). The resulting risk model had a c-statistic value of 0.76. A Hosmer-Lemeshow test confirmed good calibration of the model against the original dataset. CONCLUSION: Risk of death at 6 months in patients with a confirmed diagnosis of MPM can be predicted using variables readily available in clinical practice. The risk prediction model we have developed may be used to influence treatment decisions in patients with MPM. Further validation of the model requires evaluation of its performance on a separate dataset.

The association between ward staffing levels, mortality and hospital readmission in older hospitalised adults, according to presence of cognitive impairment: a retrospective cohort study.

BACKGROUND: Lower nurse staffing levels are associated with increased hospital mortality. Older patients with cognitive impairments (CI) have higher mortality rates than similar patients without CI and may be additionally vulnerable to low staffing. OBJECTIVES: To explore associations between registered nurse (RN) and nursing assistant (NA) staffing levels, mortality and readmission in older patients admitted to general medical/surgical wards. RESEARCH DESIGN: Retrospective cohort. PARTICIPANTS: All unscheduled admissions to an English hospital of people aged ≥75 with cognitive screening over 14 months. MEASURES: The exposure was defined as deviation in staffing hours from the ward daily mean, averaged across the patient stay. Outcomes were mortality in hospital/within 30 days of discharge and 30-day re-admission. Analyses were stratified by CI. RESULTS: 12,544 admissions were included. Patients with CI (33.2%) were exposed to similar levels of staffing as those without. An additional 0.5 RN hours per day was associated with 10% reduction in the odds of death overall (odds ratio 0.90 [95% CI 0.84-0.97]): 15% in patients with CI (OR 0.85 [0.74-0.98]) and 7% in patients without (OR 0.93 [0.85-1.02]). An additional 0.5 NA hours per day was associated with a 15% increase in mortality in patients with no impairment. Readmissions decreased by 6% for an additional 0.5 RN hours in patients with CI. CONCLUSIONS: Although exposure to low staffing was similar, the impact on mortality and readmission for patients with CI was greater. Increased mortality with higher NA staffing in patients without CI needs exploration.

A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial.

BACKGROUND: Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. METHODS: This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. RESULTS: There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). CONCLUSIONS: This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial).

BACKGROUND: Longstanding colonic IBD increases the risk of developing colorectal cancer. The utility of chromoendoscopy with standard-definition white light technology has been established. However, the use of high-definition virtual chromoendoscopy (HDV) in colitis surveillance remains undefined. OBJECTIVE: To compare the performance of HDV (i-scan OE mode 2) with high-definition white light (HDWL) for detection of neoplasia in patients with IBD undergoing surveillance colonoscopy. Additionally, we assessed the utility of protocol-guided quadrantic non-targeted biopsies. DESIGN: A multioperator randomised controlled trial was carried out in two centres in the UK. Total of 188 patients (101 men, mean age 54) with longstanding ulcerative or Crohn's colitis were randomised, prior to starting the surveillance colonoscopy, to using either HDV (n=94) or HDWL (n=94) on withdrawal. Targeted and quadrantic non-targeted biopsies were taken in both arms per-randomisation protocol. The primary outcome was the difference in neoplasia detection rate (NDR) between HDV and HDWL. RESULTS: There was no significant difference between HDWL and HDV for neoplasia detection. The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14). All intraepithelial neoplasia (IEN) detected contained low-grade dysplasia only. A total of 6751 non-targeted biopsies detected one IEN only. The withdrawal time was similar in both arms of the study; median of 24 min (HDWL) versus 25.5 min (HDV). CONCLUSION: HDV and HDWL did not differ significantly in the detection of neoplasia. Almost all neoplasia were detected on targeted biopsy or resection. Quadrantic non-targeted biopsies have negligible additional gain. TRIAL REGISTRATION NUMBER: Clinical Trial.gov ID NCT02822352.

An Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice: Protocol for the Observational VENTILATE Study.

BACKGROUND: Respiratory rate (RR) is the most sensitive physiological observation to predict clinical deterioration on hospital wards, and poor clinical monitoring has been highlighted as a primary contributor to avoidable mortality. Patients in intensive care have their RR monitored continuously, but this equipment is rarely available on general hospital wards. OBJECTIVE: The primary objective is to assess the accuracy of the RespiraSense device in comparison with other methods currently used in clinical practice. The secondary objective is to assess the accuracy of the RespiraSense device in participants in different positions and when reading aloud. METHODS: A single-center, prospective observational study will investigate the agreement of the RespiraSense device as compared with other device measurements (capnography, electrocardiogram) and the current standard measurement of RR (manual counting by a trained health care professional). The different methods will be employed concurrently on the same participant as part of a single study visit. RESULTS: Recruitment to this study has not yet started as funding decisions are still pending. Therefore, results are not available at this stage. It is anticipated that the data required could be collected within 2 months of first recruitment to the study and data analysis completed within 6 months of the study start date. CONCLUSIONS: The Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice (VENTILATE) study will provide further validation of the use of the RespiraSense device in subjects with abnormal respiratory rates. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15437.

Mindfulness-Based Interventions in Recurrent Ovarian Cancer: A Mixed-Methods Feasibility Study.

A recurrence of cancer is a traumatic and stressful experience, and a number of approaches have been proposed to manage or treat the associated psychological distress. Meditative techniques such as mindfulness may be able to improve an individual's ability to cope with stressful life events such as cancer diagnosis or treatment. This single-arm mixed-methods study primarily aimed to determine the feasibility of using a mindfulness-based intervention in managing psychosocial distress in recurrent ovarian cancer. Twenty-eight participants took part in a mindfulness-based program, involving six group sessions, each lasting 1.5 hours and delivered at weekly intervals. The study found that the mindfulness-based intervention was acceptable to women with recurrent ovarian cancer and feasible to deliver within a standard cancer care pathway in a UK hospital setting. The results suggested a positive impact on symptoms of depression and anxiety, but further study is needed to explore the effectiveness of the intervention.

Non-invasive techniques for stimulating urine production in non-toilet trained children: a systematic review.

BACKGROUND: Urinary tract infection requires collection of a sterile urine specimen for diagnosis, which is difficult and time consuming in pre-continent children. This systematic review summarises evidence of the effectiveness of bladder stimulation techniques on urine collection in pre-continent children, compared with standard techniques. METHODS: MEDLINE, PubMed, EMBASE and CINAHL were searched to May 2019. Selection, data extraction, risk of bias and quality assessment were undertaken by two independent reviewers. Inclusion: (1) all study designs; (2) pre-continent, age <3 years receiving bladder stimulation techniques; (3) outcomes including time to urine collection or contamination rates; (4) English-language articles. Exclusion: coexisting neurological disorders. RESULTS: Three randomised controlled trials (RCTs) were identified using three techniques in 568 participants aged 1 day to 35 months. Two RCTs demonstrated an increased success in voiding within 5 min, one using a finger tapping and lumbar paravertebral massage technique and the other cold saline-soaked gauze rubbed over the suprapubic region, compared with no active intervention. A third RCT using a mechanical vibration device demonstrated no difference in time to voiding from advice alone. Non-randomised studies compared different temperatures for the gauze intervention and tapping alone versus urine bags. Six uncontrolled studies tested the finger tapping and massage technique. Risk of bias was low for one RCT and unclear for two RCTs with the other studies rated poor to fair quality. Overall, the evidence on success rates was graded low for tapping plus massage and moderate for the gauze rubbing intervention. Adverse effects included crying and mild distress. DISCUSSION: The results suggest a positive effect of stimulation techniquesbut lack of replication in rigorous RCTs and heterogeneity of techniques and outcomes assessed prevent conclusive recommendations being made. Further RCTs are required comparing non-invasive stimulation methods and assessing time to successful collection, contamination rates, adverse effects, caregiver and clinical staff acceptability.

A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett's surveillance: the ABBA trial.

BACKGROUND: The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett's surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique. METHODS: This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett's surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies. RESULTS: 200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients. CONCLUSIONS: We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett's surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.

Modern Innovative Solutions in Improving Outcomes in Chronic Obstructive Pulmonary Disease (MISSION COPD): Mixed Methods Evaluation of a Novel Integrated Care Clinic.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the second-leading cause of death in the United Kingdom and accounts for 1.7% of bed days in acute hospitals. An estimated two-third of patients with COPD remain undiagnosed. OBJECTIVE: Modern Innovative Solutions in Improving Outcomes in Chronic Obstructive Pulmonary Disease (MISSION COPD) aimed to proactively identify patients from primary care who were undiagnosed or had uncontrolled COPD and to provide a comprehensive integrated multidisciplinary clinic to address the needs of this complex group for improving diagnosis, personalizing therapy, and empowering patients to self-manage their condition. METHODS: This clinic was led by a respiratory specialist team from Portsmouth Hospitals NHS Trust working with five primary care surgeries in Wessex. A total of 108 patients were reviewed, with 98 patients consenting to provide additional data for research. Diagnoses were changed in 14 patients, and 32 new diagnoses were made. RESULTS: Reductions were seen across all aspects of unscheduled care as compared to the prior 12 months, including in emergency general practitioner visits (3.37-0.79 visits per patient, P<.001), exacerbations (2.64-0.56 per patient, P=.01), out-of-hours calls (0.16-0.05 per patient, P=.42), and hospital admissions (0.49-0.12 per patient, P=.48). Improvements were observed in the quality of life and symptom scores in addition to patient activation and patient-reported confidence levels. CONCLUSIONS: This pilot demonstrates that the MISSION model may be an effective way to provide comprehensive gold-standard care that is valued by patients and to promote integration across sectors.

Modern Innovative Solutions to Improve Outcomes in Severe Asthma: Protocol for a Mixed Methods Observational Comparison of Clinical Outcomes in MISSION Versus Current Care Delivery.

BACKGROUND: Asthma that is poorly controlled and undertreated can progress to more severe disease that is associated with high levels of unscheduled care that requires high-cost therapy, leading to a significant health economic burden. The identification and appropriate referral to a specialist asthma service is also often delayed by several months or years because of poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multidisciplinary assessment, often necessitating multiple hospital visits and costing up to £5000 per patient. OBJECTIVE: This study aims to evaluate whether a new service model could identify poorly controlled and potentially severe asthma much earlier in the patient pathway, and then compare clinical outcomes between this new care model with standard care. METHODS: Modern Innovative Solutions to Improve Outcomes in (MISSION) Severe Asthma is a novel service model developed by asthma specialists from Portsmouth and Southampton severe asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from general practice databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In 1- or 2-stop assessments, a thorough review of diagnosis, disease phenotype, and control is undertaken, and clinical outcomes collected at baseline. RESULTS: A variety of clinical outcomes will be collected to assess the service model. The results will be reported in February 2020. CONCLUSIONS: This protocol outlines a mixed methods study to assess the impact on disease control, unscheduled health care usage, and quality of life in patients seen in the MISSION clinic compared with a closely matched cohort who declined to attend. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/9585.

Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT.

BACKGROUND: Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients. OBJECTIVE: To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma. DESIGN: A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups. SETTING: Fourteen hospitals in the UK that manage patients with severe asthma. PARTICIPANTS: Adults (16-75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen. INTERVENTION: Nocturnal, home-based TLA treatment using an Airsonett® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second. MAIN OUTCOME MEASURES: Primary outcome - frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes - changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness. RESULTS: Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised (n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9-12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device. LIMITATIONS: Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive. CONCLUSIONS: Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46346208. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.

Allergies (along with viruses) are common triggers of asthma exacerbations or 'attacks', which can cause suffering and frequent visits to the general practitioner or hospital. A new machine known as a temperature-controlled laminar airflow device, which remains at the bedside and is switched on every night, filters out allergy particles in the air of a patient's breathing zone, allowing their lungs to rest in clean air overnight. We tested whether or not this machine could improve the lives of those with severe allergic asthma. We recruited 240 people across 14 centres that treat severe asthma across the UK; approximately half received the active device and the other half received a machine that looked exactly the same but did not remove the allergens (a 'placebo' machine). One in five participants was recruited using newer methods of social media such as Facebook (Facebook, Inc., Menlo Park, CA, USA) and Twitter (Twitter, Inc., San Francisco, CA, USA). Participants found the machine easy to use and to live with and there were no significant side effects. The number of attacks reduced a lot in both participants using the active device and those who used the placebo device ­ two participants in five did not suffer any attacks during the trial. However, there was no difference in the number of attacks between the two groups. This might have been because participants did not record everything that happened to them. There was no difference in measurements showing how well the lungs were working, nor in participants' quality of life after 1 year of participating in the trial. Those who were interviewed told us that the study visits and questionnaires could be burdensome, although it was helpful to think more about their asthma. An improvement was seen in one aspect of participants' breathing as well as in their quality of life after 6 months of using the machine, but these potential health benefits could not outweigh the cost of the machine.

Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC): Protocol for a Mixed-Methods Study.

BACKGROUND: A high proportion of the costs for respiratory diseases are generated by a relatively small group of patients with severe disease (recognized or unrecognized) or complex problems that include multimorbidity, at-risk behaviors, and socioeconomic disadvantage. These patients often struggle to engage with the structured, proactive, care approaches for chronic disease management advocated for asthma and chronic obstructive pulmonary disease (COPD), resulting in repeated emergency use of both primary and secondary health care. An integrated approach for the management of complex patients, incorporating both specialist and primary care teams' expertise, may be effective in improving outcomes for such high-risk patients. However, the evidence is mixed, and there is a need for evaluation of models of integrated care in routine "real-world" clinical settings. OBJECTIVE: This mixed-methods protocol examines the implementation of a novel integrated care model for patients with airways disease and undifferentiated breathlessness by using both quantitative and qualitative evaluation of processes, patient and health care professional experiences, and clinical outcomes throughout the clinic cycles. It aims to establish whether Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC), including innovative diagnostic and self-management tools, can deliver improvements in health service use and clinical outcomes for the different patient groups (asthma, breathlessness, and COPD) and compares the 12-month period prior to the first patient visit and the 6-month period following the last visit. METHODS: A combination of study designs is required to evaluate all aspects of the service: participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics; before-and-after study for patient outcomes before and after clinic attendance; and qualitative methods (interviews and focus groups). RESULTS: The results will be compiled and published in April 2019. CONCLUSIONS: Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers, and health care professionals in addition to quantitative outcomes for service implementation and patient factors. The long-term impact of the service will be evaluated using clinical and health service outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/9228.

Cognitive impairment is independently associated with mortality, extended hospital stays and early readmission of older people with emergency hospital admissions: A retrospective cohort study.

BACKGROUND: Older adults admitted to hospital are often cognitively impaired. It is not clear whether the presence of cognitive impairment conveys an additional risk for poor hospital outcomes in this patient population. OBJECTIVES: To determine whether cognitive impairment in hospitalised older adults is independently associated with poor outcomes. DESIGN: Retrospective cohort study using electronic, routinely collected data from linked clinical and administrative databases. SETTING: Large, acute district general hospital in England. PARTICIPANTS: 21,399 incident emergency admissions of people aged ≥75, screened for cognitive impairment, categorised to 3 groups: (i) cognitive impairment with a diagnosis of dementia, (ii) cognitive impairment with no dementia diagnosis, (iii) no cognitive impairment. METHODS: Multivariable logistic regression and Fine and Gray competing risks survival models were employed to explore associations between cognitive impairment and mortality (in-hospital alone, and in-hospital plus up to 30 days after discharge), time to hospital discharge, and hospital readmission within 30 days of discharge. Covariates included age, severity of illness, main diagnosis, comorbidities and nutritional risk. RESULTS: Twenty-seven percent of patients had cognitive impairment; of these, 61.5% had a diagnosis of dementia and 38.5% did not. Patients with cognitive impairment and no diagnosis of dementia were most likely to die in hospital or be readmitted, they also had the longest hospital stays. Cognitive impairment was independently associated with mortality in hospital (Odds Ratio 1.34 [1.17-1.55] with dementia; Odds Ratio 1.78 [1.52-2.07] without), mortality in hospital or within 30 days of discharge (Odds Ratio 1.66 [1.48-1.86]; Odds Ratio 1.67 [1.46-1.90]); readmission (Odds Ratio 1.21 [1.04-1.40]; Odds Ratio 1.47 [1.25-1.73]), and increased time until discharge (sub-hazard ratio 0.80 [0.76-0.83]; sub-hazard ratio 0.66 [0.63-0.69]). CONCLUSIONS: Cognitive impairment is associated with an increased risk of adverse outcomes in hospitalised older people with an unscheduled admission, by increasing hospital mortality, extending hospital stays and increasing frequency of readmissions. Future research should focus on understanding the mechanisms contributing to poorer outcomes in this population.