The impact of digital technology in care homes on unplanned secondary care usage and associated costs.

BACKGROUND: A substantial number of Emergency Department (ED) attendances by care home residents are potentially avoidable. Health Call Digital Care Homes is an app-based technology that aims to streamline residents' care by recording their observations such as vital parameters electronically. Observations are triaged by remote clinical staff. This study assessed the effectiveness of the Health Call technology to reduce unplanned secondary care usage and associated costs. METHODS: A retrospective analysis of health outcomes and economic impact based on an intervention. The study involved 118 care homes across the North East of UK from 2018 to 2021. Routinely collected NHS secondary care data from County Durham and Darlington NHS Foundation Trust was linked with data from the Health Call app. Three outcomes were modelled monthly using Generalised Linear Mixed Models: counts of emergency attendances, emergency admissions and length of stay of emergency admissions. A similar approach was taken for costs. The impact of Health Call was tested on each outcome using the models. FINDINGS: Data from 8,702 residents were used in the analysis. Results show Health Call reduces the number of emergency attendances by 11% [6-15%], emergency admissions by 25% [20-39%] and length of stay by 11% [3-18%] (with an additional month-by-month decrease of 28% [24-34%]). The cost analysis found a cost reduction of £57 per resident in 2018, increasing to £113 in 2021. INTERPRETATION: The introduction of a digital technology, such as Health Call, could significantly reduce contacts with and costs resulting from unplanned secondary care usage by care home residents.

Real world evidence supports waking salivary cortisone as a screening test for adrenal insufficiency.

OBJECTIVE: Worldwide, adults and children are at risk of adrenal insufficiency largely due to infectious diseases and adrenal suppression from use of anti-inflammatory glucocorticoids. Home waking salivary cortisone is an accurate screening test for adrenal insufficiency, it has potential to reduce costs, and patients prefer it to the adrenocorticotropin (ACTH) (synacthen) stimulation test. We carried out a service evaluation of home waking salivary cortisone in clinical care to identify implementation barriers. DESIGN, PATIENTS AND MEASUREMENTS: Service evaluation in a centre where 212 patients referred for adrenal insufficiency had a waking salivary cortisone. Problems encountered during testing were recorded and patient feedback, via focus groups, collected. RESULTS: From all patients providing a waking salivary cortisone 55% had a normal test, 23% adrenal suppression, and 22% an equivocal result requiring a clinical centre ACTH stimulation test. The median (interquartile range [IQR]) for the time of the saliva sample was 07:40 (07:00-08:40). The median (IQR) days between collection and (i) delivery to local laboratory was 1 (0.25-2) day; (ii) reporting by local laboratory was 13 (11-18) days. Patients considered the test is "easy to do" and preferred it to the inpatient ACTH stimulation test. The principal challenge to clinical implementation was results reporting to clinicians due to delays at the local laboratory. CONCLUSIONS: This service evaluation provides real-world evidence that home waking salivary cortisone is an effective, practical screening test for adrenal insufficiency. It identified key barriers to testing implementation that need to be addressed when introducing the test to a health service.

Use of urgent, emergency and acute care by mental health service users: A record-level cohort study.

BACKGROUND: People with serious mental illness experience worse physical health and greater mortality than the general population. Crude rates of A&E attendance and acute hospital admission are higher in people with serious mental illness than other hospital users. We aimed to further these findings by undertaking a standardised comparison of urgent and emergency care pathway use among users of mental health services and the general population. METHODS: Retrospective cohort analysis using routine data from 2013-2016 from the CUREd dataset for urgent and emergency care contacts (NHS 111, ambulance, A&E and acute admissions) and linked mental health trust data for Sheffield, England. We compared annual age- and sex-standardised usage rates for each urgent and emergency care service between users of mental health services and those without a recent history of mental health service use. RESULTS: We found marked differences in usage rates for all four urgent and emergency care services between the general population and users of mental health services. Usage rates and the proportion of users were 5-6 times and 3-4 times higher in users of mental health services, respectively, for all urgent and emergency care services. Users of mental health services were often more likely to experience the highest or lowest acuity usage characteristics. CONCLUSIONS: Current users of mental health services were heavily over-represented among urgent and emergency care users, and they made more contacts per-person. Higher service use among users of mental health services could be addressed by improved community care, more integrated physical and mental health support, and more proactive primary care. A complex pattern of service use among users of mental health services suggests this will need careful targeting to reduce avoidable contacts and optimise patient outcomes.

Home Waking Salivary Cortisone to Screen for Adrenal Insufficiency.

At-Home Cortisone Screen for Adrenal InsufficiencyThis prospective study tested the use of home waking salivary cortisone levels to predict adrenal insufficiency. Salivary cortisone had diagnostic accuracy similar to that of a standard adrenocorticotropin stimulation test and was preferred by patients.

A descriptive study of samples sizes used in agreement studies published in the PubMed repository.

INTRODUCTION: A sample size justification is required for all studies and should give the minimum number of subjects to be recruited for the study to achieve its primary objective. The aim of this review is to describe sample sizes from agreement studies with continuous or categorical endpoints and different methods of assessing agreement, and to determine whether sample size justification was provided. METHODS: Data were gathered from the PubMed repository with a time interval of 28th September 2018 to 28th September 2020. The search returned 5257 studies of which 82 studies were eligible for final assessment after duplicates and ineligible studies were excluded. RESULTS: We observed a wide range of sample sizes. Forty-six studies (56%) used a continuous outcome measure, 28 (34%) used categorical and eight (10%) used both. Median sample sizes were 50 (IQR 25 to 100) for continuous endpoints and 119 (IQR 50 to 271) for categorical endpoints. Bland-Altman limits of agreement (median sample size 65; IQR 35 to 124) were the most common method of statistical analysis for continuous variables and Kappa coefficients for categorical variables (median sample size 71; IQR 50 to 233). Of the 82 studies assessed, only 27 (33%) gave justification for their sample size. CONCLUSIONS: Despite the importance of a sample size justification, we found that two-thirds of agreement studies did not provide one. We recommend that all agreement studies provide rationale for their sample size even if they do not include a formal sample size calculation.

Frequent attendance at the emergency department shows typical features of complex systems: analysis of multicentre linked data.

OBJECTIVE: Frequent attendance at the ED is a worldwide problem. We hypothesised that frequent attendance could be understood as a feature of a complex system comprising patients, healthcare and society. Complex systems have characteristic statistical properties, with stable patterns at the level of the system emerging from unstable patterns at the level of individuals who make up the system. METHODS: Analysis of a linked dataset of routinely collected health records from all 13 hospital trusts providing ED care in the Yorkshire and Humber region of the UK (population 5.5 million). We analysed the distribution of attendances per person in each of 3 years and measured the transition of individual patients between frequent, infrequent and non-attendance. We fitted data to power law distributions typically seen in complex systems using maximum likelihood estimation. RESULTS: The data included 3.6 million attendances at EDs in 13 hospital trusts. 29/39 (74.3%) analyses showed a statistical fit to a power law; 2 (5.1%) fitted an alternative distribution. All trusts' data fitted a power law in at least 1 year. Differences over time and between hospital trusts were small and partly explained by demographics. In contrast, individual patients' frequent attendance was unstable between years. CONCLUSIONS: ED attendance patterns are stable at the level of the system, but unstable at the level of individual frequent attenders. Attendances follow a power law distribution typical of complex systems. Interventions to address ED frequent attendance need to consider the whole system and not just the individual frequent attenders.

Prospectively predicting Pseudomonas aeruginosa infection/s using routine data from the UK cystic fibrosis register.

RATIONALE AND AIMS: Lung health of people with cystic fibrosis (PwCF) can be preserved by daily use of inhaled therapy. Adherence to inhaled therapy, therefore, provides an important process measure to understand the success of care and can be used as a quality indicator. Defining adherence is problematic, however, since the number of prescribed treatments varies considerably between PwCF. The problem is less pronounced among those with Pseudomonas aeruginosa (PA), for whom at least three daily doses of nebulized therapy should be prescribed and who thus constitute a more homogeneous group. The UK CF Registry provides routine data on PA status, but data are only available 12 months after collection. In this study, we aim to prospectively identify contemporary PA status from historic registry data. METHOD: UK CF Registry data from 2011 to 2015 for PwCF aged ≥16 was used to determine a pragmatic prediction rule for identifying contemporary PA status using historic registry data. Accuracy of three different prediction rules was assessed using the positive predictive value (PPV). The number and proportion of adults predicted to have PA infection were determined overall and per center for the selected prediction rule. Known characteristics linked to PA status were explored to ensure the robustness of the prediction rule. RESULTS: Having CF Registry defined chronic PA status in the two previous years is the selected definition to predict a patient will have PA infection within the current year (population-level PPV = 96%-97%, centre level PPV = 85%-100%). This approach provides a subset of data between 1852 and 1872 patients overall and a range of 8 to 279 patients per center. CONCLUSION: Historic registry data can be used to contemporaneously identify a subgroup of patients with chronic PA. Since this patient group has a narrower treatment schedule, this can facilitate a better benchmarking of adherence across centers.

Sample sizes for cluster-randomised trials with continuous outcomes: Accounting for uncertainty in a single intra-cluster correlation estimate.

Sample size calculations for cluster-randomised trials require inclusion of an inflation factor taking into account the intra-cluster correlation coefficient. Often, estimates of the intra-cluster correlation coefficient are taken from pilot trials, which are known to have uncertainty about their estimation. Given that the value of the intra-cluster correlation coefficient has a considerable influence on the calculated sample size for a main trial, the uncertainty in the estimate can have a large impact on the ultimate sample size and consequently, the power of a main trial. As such, it is important to account for the uncertainty in the estimate of the intra-cluster correlation coefficient. While a commonly adopted approach is to utilise the upper confidence limit in the sample size calculation, this is a largely inefficient method which can result in overpowered main trials. In this paper, we present a method of estimating the sample size for a main cluster-randomised trial with a continuous outcome, using numerical methods to account for the uncertainty in the intra-cluster correlation coefficient estimate. Despite limitations with this initial study, the findings and recommendations in this paper can help to improve sample size estimations for cluster randomised controlled trials by accounting for uncertainty in the estimate of the intra-cluster correlation coefficient. We recommend this approach be applied to all trials where there is uncertainty in the intra-cluster correlation coefficient estimate, in conjunction with additional sources of information to guide the estimation of the intra-cluster correlation coefficient.

Impact of health technology assessment on prescribing patterns of inhaled fixed-dose combination triple therapy in chronic obstructive pulmonary disease.

Background: Evidence suggests that triple therapy for patients with chronic obstructive pulmonary disease (COPD) is being used in a broader range of patients than recommended by guidelines, which may have health and cost implications. Objective: To explore the relationship between national health technology assessment (HTA) agency appraisals and market penetration of two fixed-dose combination (FDC) triple therapies. Study design: HTAs from Q3 2017 to Q1 2020 from 10 countries were evaluated. Intervention: Glycopyrronium bromide/formoterol fumarate/beclomethasone (Trimbow®) and umeclidinium/vilanterol/fluticasone furoate (Trelegy™ Ellipta®). Main outcome measure: HTA restrictions and prescribing rates (days of therapy). Results: Seven countries (70%) imposed restrictions on use including prescription only for patients stable on free-combination triple therapy or not controlled on dual therapy, requirement of a specialist prescription or therapeutic plan, prescription only for patients with severe COPD, and use as second-line therapy or later. In general, countries that have imposed restrictions on the use of FDC triple therapies have seen a lower than average uptake. Conclusion: Payer guidance on prescribing FDC triple therapy may potentially support more appropriate prescribing in line with clinical guidelines. It is important for payers to consider which restrictions would ensure the most efficient use of scarce resources.

Patient compliance with NHS 111 advice: Analysis of adult call and ED attendance data 2013-2017.

The NHS 111 telephone advice and triage service is a vital part of the management of urgent and emergency care (UEC) services in England. Demand for NHS 111 advice has increased since its introduction in 2013, and the service is of particular importance in light of the current pandemic and resulting increased demand for emergency care. Currently, little is known about the effectiveness of NHS 111 in terms of the appropriateness of the advice given, or about the compliance of patients with that advice. We aimed to address this issue by analysing a large linked routine dataset of all NHS 111 calls (n = 3,631,069) and subsequent emergency department (ED) attendances made in the Yorkshire & Humber region from March 2013-March 2017. We found that many patients do not comply with advice, with 11% (n = 289,748) of patients attending ED when they are advised to self-care or seek primary care. We also found that a considerable number of these patients are further classed as urgent (88%, n = 255,931) and a substantial minority (37%, 106,207) are subsequently admitted to hospital. Further, many patients who are sent an ambulance or told to attend ED are classed as non-urgent upon attending ED (9%, n = 42,372). This research suggests that the level at which NHS 111 is currently triaging results in many hundreds of thousands of mis-triaged cases annually. Additionally, patients frequently do not comply with the advice they receive. This has implications for understanding the accuracy and efficiency of triaging systems.

Angiotensin converting enzyme inhibitors do not increase the risk of poor outcomes in COVID-19 disease. A multi-centre observational study.

BACKGROUND AND AIMS: Hypertension is associated with an increased risk of severe outcomes with COVID-19 disease. Angiotensin Converting Enzyme (ACE) inhibitors are widely used as a first line medication for the treatment of hypertension in the UK, although their use was suggested in early reports to increase the risk associated with SARS-CoV-2 infection. METHODS: A prospective cohort study of hospitalised patients with laboratory confirmed COVID-19 was conducted across three hospital sites with patients identified on the 9th April 2020. Demographic and other baseline data were extracted from electronic case records, and patients grouped depending on ACE inhibitor usage or not. The 60-day all-cause mortality and need for intubation compared. RESULTS: Of the 173 patients identified, 88 (50.8%) had hypertension. Of these 27 (30.7%) used ACE inhibitors. We did not find significant differences in 60-day all-cause mortality, the requirement for invasive ventilation or length of stay between our patient cohorts after adjusting for covariates. CONCLUSION: This study contributes to the growing evidence supporting the continued use of ACE inhibitors in COVID-19 disease, although adequately powered randomised controlled trials will be needed to confirm effects.

Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review.

BACKGROUND: Guidelines recommend that treatment with a long-acting ß2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and inhaled corticosteroids (ICS), i.e. triple therapy, is reserved for a select group of symptomatic patients with chronic obstructive pulmonary disease (COPD) who continue to exacerbate despite treatment with dual therapy (LABA/LAMA). A number of single-inhaler triple therapies are now available and important clinical questions remain over their role in the patient pathway. We compared the efficacy and safety of single-inhaler triple therapy to assess the magnitude of benefit and to identify patients with the best risk-benefit profile for treatment. We also evaluated and compared study designs and population characteristics to assess the strength of the evidence base. METHODS: We conducted a systematic search, from inception to December 2018, of randomised controlled trials (RCTs) of single-inhaler triple therapy in patients with COPD. The primary outcome was the annual rate of moderate and severe exacerbations. RESULTS: We identified 523 records, of which 15 reports/abstracts from six RCTs were included. Triple therapy resulted in the reduction of the annual rate of moderate or severe exacerbations in the range of 15-52% compared with LAMA/LABA, 15-35% compared to LABA/ICS and 20% compared to LAMA. The patient-based number needed to treat for the moderate or severe exacerbation outcome ranged between approximately 25-50 (preventing one patient from having an event) and the event-based number needed to treat of around 3-11 (preventing one event). The absolute benefit appeared to be greater in patients with higher eosinophil counts or historical frequency of exacerbations and ex-smokers. In the largest study, there was a significantly higher incidence of pneumonia in the triple therapy arm. There were important differences in study designs and populations impacting the interpretation of the results and indicating there would be significant heterogeneity in cross-trial comparisons. CONCLUSION: The decision to prescribe triple therapy should consider patient phenotype, magnitude of benefit and increased risk of adverse events. Future research on specific patient phenotype thresholds that can support treatment and funding decisions is now required from well-designed, robust, clinical trials. TRIAL REGISTRATION: PROSPERO #CRD42018102125 .

AccessLab: Workshops to broaden access to scientific research.

AccessLabs are workshops with two simultaneous motivations, achieved through direct citizen-scientist pairings: (1) to decentralise research skills so that a broader range of people are able to access/use scientific research, and (2) to expose science researchers to the difficulties of using their research as an outsider, creating new open access advocates. Five trial AccessLabs have taken place for policy makers, media/journalists, marine sector participants, community groups, and artists. The act of pairing science academics with local community members helps build understanding and trust between groups at a time when this relationship appears to be under increasing threat from different political and economic currents in society. Here, we outline the workshop motivations, format, and evaluation, with the aim that others can build on the methods developed.