The cost-effectiveness of procalcitonin for guiding antibiotic prescribing in individuals hospitalized with COVID-19: part of the PEACH study.

BACKGROUND: Many hospitals introduced procalcitonin (PCT) testing to help diagnose bacterial coinfection in individuals with COVID-19, and guide antibiotic decision-making during the COVID-19 pandemic in the UK. OBJECTIVES: Evaluating cost-effectiveness of using PCT to guide antibiotic decisions in individuals hospitalized with COVID-19, as part of a wider research programme. METHODS: Retrospective individual-level data on patients hospitalized with COVID-19 were collected from 11 NHS acute hospital Trusts and Health Boards from England and Wales, which varied in their use of baseline PCT testing during the first COVID-19 pandemic wave. A matched analysis (part of a wider analysis reported elsewhere) created groups of patients whose PCT was/was not tested at baseline. A model was created with combined decision tree/Markov phases, parameterized with quality-of-life/unit cost estimates from the literature, and used to estimate costs and quality-adjusted life years (QALYs). Cost-effectiveness was judged at a £20 000/QALY threshold. Uncertainty was characterized using bootstrapping. RESULTS: People who had baseline PCT testing had shorter general ward/ICU stays and spent less time on antibiotics, though with overlap between the groups' 95% CIs. Those with baseline PCT testing accrued more QALYs (8.76 versus 8.62) and lower costs (£9830 versus £10 700). The point estimate was baseline PCT testing being dominant over no baseline testing, though with uncertainty: the probability of cost-effectiveness was 0.579 with a 1 year horizon and 0.872 with a lifetime horizon. CONCLUSIONS: Using PCT to guide antibiotic therapy in individuals hospitalized with COVID-19 is more likely to be cost-effective than not, albeit with uncertainty.

Evidence of quality of life for hospitalised patients with COVID-19: a scoping review.

Background: Information on the quality of life of people hospitalised with COVID-19 is important, both in assessing the burden of disease and the cost-effectiveness of treatments. However, there were potential barriers to collecting such evidence. Objective: To review the existing evidence on quality of life for people hospitalised with COVID-19, with a focus on the amount of evidence available and methods used. Design: A scoping review with systematic searches. Results: A total of 35 papers were selected for data extraction. The most common study type was economic evaluation (N = 13), followed by cross-sectional (N = 10). All economic evaluations used published utility values for other conditions to represent COVID-19 inpatients' quality of life. The most popular quality-of-life survey measure was the Pittsburgh Sleep Quality Index (N = 8). There were 12 studies that used a mental health-related survey and 12 that used a sleep-related survey. Five studies used EQ-5D, but only one collected responses from people in the acute phase of COVID-19. Studies reported a negative impact on quality of life for people hospitalised with COVID-19, although many studies did not include a formal comparison group. Limitations: Although it used systematic searches, this was not a full systematic review. Conclusion: Quality-of-life data were collected from people hospitalised with COVID-19 from relatively early in the pandemic. However, there was a lack of consensus as to what survey measures to use, and few studies used generic health measures. Economic evaluations for COVID-19 treatments did not use utilities collected from people with COVID-19. In future health crises, researchers should be vigilant for opportunities to collect quality-of-life data from hospitalised patients but should try to co-ordinate as well as ensuring generic health measures are used more. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR132254.

Quality of life can be measured using short, simple surveys. It is important to assess quality of life in this way, as it can show how health conditions affect people. Quality-of-life surveys can also be used to measure how treatments benefit people and to judge whether it is cost-effective to fund them. COVID-19 is a new disease, with new treatments developed to treat it. COVID-19 also created possible barriers to collecting quality-of-life survey data, especially from people in hospital at the start of the pandemic. This paper reviews studies which report data on quality of life for people hospitalised with COVID-19, especially how much evidence is available and how the studies were carried out. There were 35 studies included in the review. Of these, 13 assessed how cost-effective treatments for COVID-19 were. None of them collected survey responses directly from patients. Instead, they used data previously collected from people with other conditions such as influenza to represent people with COVID-19's quality of life. The studies which did collect data from patients used a wide variety of different surveys, which made comparing their results difficult. Mental health-related surveys were used by 12 studies, and a further 12 used sleep-related surveys. Relatively few studies used general surveys which could assess the overall effect of COVID-19 on people's quality of life. In future health crises, we recommend using more general quality-of-life measures. We also recommend that researchers co-ordinate to reduce the number of different surveys they use, as this will make comparing results easier.

Target Product Profile for a Machine Learning-Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study.

BACKGROUND: Diabetic eye screening (DES) represents a significant opportunity for the application of machine learning (ML) technologies, which may improve clinical and service outcomes. However, successful integration of ML into DES requires careful product development, evaluation, and implementation. Target product profiles (TPPs) summarize the requirements necessary for successful implementation so these can guide product development and evaluation. OBJECTIVE: This study aims to produce a TPP for an ML-automated retinal imaging analysis software (ML-ARIAS) system for use in DES in England. METHODS: This work will consist of 3 phases. Phase 1 will establish the characteristics to be addressed in the TPP. A list of candidate characteristics will be generated from the following sources: an overview of systematic reviews of diagnostic test TPPs; a systematic review of digital health TPPs; and the National Institute for Health and Care Excellence's Evidence Standards Framework for Digital Health Technologies. The list of characteristics will be refined and validated by a study advisory group (SAG) made up of representatives from key stakeholders in DES. This includes people with diabetes; health care professionals; health care managers and leaders; and regulators and policy makers. In phase 2, specifications for these characteristics will be drafted following a series of semistructured interviews with participants from these stakeholder groups. Data collected from these interviews will be analyzed using the shortlist of characteristics as a framework, after which specifications will be drafted to create a draft TPP. Following approval by the SAG, in phase 3, the draft will enter an internet-based Delphi consensus study with participants sought from the groups previously identified, as well as ML-ARIAS developers, to ensure feasibility. Participants will be invited to score characteristic and specification pairs on a scale from "definitely exclude" to "definitely include," and suggest edits. The document will be iterated between rounds based on participants' feedback. Feedback on the draft document will be sought from a group of ML-ARIAS developers before its final contents are agreed upon in an in-person consensus meeting. At this meeting, representatives from the stakeholder groups previously identified (minus ML-ARIAS developers, to avoid bias) will be presented with the Delphi results and feedback of the user group and asked to agree on the final contents by vote. RESULTS: Phase 1 was completed in November 2023. Phase 2 is underway and expected to finish in March 2024. Phase 3 is expected to be complete in July 2024. CONCLUSIONS: The multistakeholder development of a TPP for an ML-ARIAS for use in DES in England will help developers produce tools that serve the needs of patients, health care providers, and their staff. The TPP development process will also provide methods and a template to produce similar documents in other disease areas. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50568.

Evidence Synthesis and Linkage for Modelling the Cost-Effectiveness of Diagnostic Tests: Preliminary Good Practice Recommendations.

OBJECTIVES: To develop preliminary good practice recommendations for synthesising and linking evidence of treatment effectiveness when modelling the cost-effectiveness of diagnostic tests. METHODS: We conducted a targeted review of guidance from key Health Technology Assessment (HTA) bodies to summarise current recommendations on synthesis and linkage of treatment effectiveness evidence within economic evaluations of diagnostic tests. We then focused on a specific case study, the cost-effectiveness of troponin for the diagnosis of myocardial infarction, and reviewed the approach taken to synthesise and link treatment effectiveness evidence in different modelling studies. RESULTS: The Australian and UK HTA bodies provided advice for synthesising and linking treatment effectiveness in diagnostic models, acknowledging that linking test results to treatment options and their outcomes is common. Across all reviewed models for the case study, uniform test-directed treatment decision making was assumed, i.e., all those who tested positive were treated. Treatment outcome data from a variety of sources, including expert opinion, were utilised for linked clinical outcomes. Preliminary good practice recommendations for data identification, integration and description are proposed. CONCLUSION: Modelling the cost-effectiveness of diagnostic tests poses unique challenges in linking evidence on test accuracy to treatment effectiveness data to understand how a test impacts patient outcomes and costs. Upfront consideration of how a test and its results will likely be incorporated into patient diagnostic pathways is key to exploring the optimal design of such models. We propose some preliminary good practice recommendations to improve the quality of cost-effectiveness evaluations of diagnostics tests going forward.

The National Health Service urgent cancer referral pathway for suspected urological cancers: early economic evaluation of a risk prediction test.

OBJECTIVES: In the UK, the number of patients urgently referred for suspected cancer is increasing, and providers are struggling to cope with demand. We explore the potential cost-effectiveness of a new risk prediction test - the PinPoint test - to triage and prioritize patients urgently referred with suspected urological cancers. METHODS: Two simulation models were developed to reflect the diagnostic pathways for patients with (i) suspected prostate cancer, and (ii) bladder or kidney cancer, comparing the PinPoint test to current practice. An early economic analysis was conducted from a UK National Health Service (NHS) perspective. The primary outcomes were the percentage of individuals seen within 2 weeks and health care costs. An exploratory analysis was conducted to understand the potential impact of the Pinpoint test on quality-adjusted life years gained. RESULTS: Across both models and applications, the PinPoint test led to more individuals with urological cancer being seen within 2 weeks. Using PinPoint only to prioritize patients led to increased costs overall, whereas using PinPoint to both triage and prioritize patients led to cost savings. The estimated impact on life years gained/lost was very small and highly uncertain. CONCLUSIONS: Using the PinPoint test to prioritize urgent referrals meant that more individuals with urological cancer were seen within 2 weeks, but at additional cost to the NHS. If used as a triage and prioritization tool, the PinPoint test shortens wait times for referred individuals and is cost saving. More data on the impact of short-term delays to diagnosis on health-related quality of life is needed.

Short-term psychosocial outcomes of adding a non-contrast abdominal computed tomography (CT) scan to the thoracic CT within lung cancer screening.

OBJECTIVES: To evaluate psychological, social, and financial outcomes amongst individuals undergoing a non-contrast abdominal computed tomography (CT) scan to screen for kidney cancer and other abdominal malignancies alongside the thoracic CT within lung cancer screening. SUBJECTS AND METHODS: The Yorkshire Kidney Screening Trial (YKST) is a feasibility study of adding a non-contrast abdominal CT scan to the thoracic CT within lung cancer screening. A total of 500 participants within the YKST, comprising all who had an abnormal CT scan and a random sample of one-third of those with a normal scan between 14/03/2022 and 24/08/2022 were sent a questionnaire at 3 and 6 months. Outcomes included the Psychological Consequences Questionnaire (PCQ), the short-form of the Spielberger State-Trait Anxiety Inventory, and the EuroQoL five Dimensions five Levels scale (EQ-5D-5L). Data were analysed using regression adjusting for participant age, sex, socioeconomic status, education, baseline quality of life (EQ-5D-5L), and ethnicity. RESULTS: A total of 380 (76%) participants returned questionnaires at 3 months and 328 (66%) at 6 months. There was no difference in any outcomes between participants with a normal scan and those with abnormal scans requiring no further action. Individuals requiring initial further investigations or referral had higher scores on the negative PCQ than those with normal scans at 3 months (standardised mean difference 0.28 sd, 95% confidence interval 0.01-0.54; P = 0.044). The difference was greater in those with anxiety or depression at baseline. No differences were seen at 6 months. CONCLUSION: Screening for kidney cancer and other abdominal malignancies using abdominal CT alongside the thoracic CT within lung cancer screening is unlikely to cause significant lasting psychosocial or financial harm to participants with incidental findings.

Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial.

INTRODUCTION: Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing. METHODS AND ANALYSIS: The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation. ETHICS AND DISSEMINATION: This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal. TRIAL REGISTRATION: ISRCTN20579216.

Measuring spirometry in a lung cancer screening cohort highlights possible underdiagnosis and misdiagnosis of COPD.

Introduction: COPD is underdiagnosed, and measurement of spirometry alongside low-dose computed tomography (LDCT) screening for lung cancer is one strategy to increase earlier diagnosis of this disease. Methods: Ever-smokers at high risk of lung cancer were invited to the Yorkshire Lung Screening Trial for a lung health check (LHC) comprising LDCT screening, pre-bronchodilator spirometry and a smoking cessation service. In this cross-sectional study we present data on participant demographics, respiratory symptoms, lung function, emphysema on imaging and both self-reported and primary care diagnoses of COPD. Multivariable logistic regression analysis identified factors associated with possible underdiagnosis and misdiagnosis of COPD in this population, with airflow obstruction defined as forced expiratory volume in 1 s/forced vital capacity ratio <0.70. Results: Out of 3920 LHC attendees undergoing spirometry, 17% had undiagnosed airflow obstruction with respiratory symptoms, representing potentially undiagnosed COPD. Compared to those with a primary care COPD code, this population had milder symptoms, better lung function and were more likely to be current smokers (p≤0.001 for all comparisons). Out of 836 attendees with a primary care COPD code who underwent spirometry, 19% did not have airflow obstruction, potentially representing misdiagnosed COPD, although symptom burden was high. Discussion: Spirometry offered alongside LDCT screening can potentially identify cases of undiagnosed and misdiagnosed COPD. Future research should assess the downstream impact of these findings to determine whether any meaningful changes to treatment and outcomes occur, and to assess the impact on co-delivering spirometry on other parameters of LDCT screening performance such as participation and adherence. Additionally, work is needed to better understand the aetiology of respiratory symptoms in those with misdiagnosed COPD, to ensure that this highly symptomatic group receive evidence-based interventions.

Diagnoses and treatments for participants with interstitial lung abnormalities detected in the Yorkshire Lung Screening Trial.

INTRODUCTION: Interstitial lung abnormalities (ILA) are relatively common incidental findings in participants undergoing low-dose CT screening for lung cancer. Some ILA are transient and inconsequential, but others represent interstitial lung disease (ILD). Lung cancer screening therefore offers the opportunity of earlier diagnosis and treatment of ILD for some screening participants. METHODS: The prevalence of ILA in participants in the baseline screening round of the Yorkshire Lung Screening Trial is reported, along with the proportion referred to a regional ILD service, eventual diagnoses, outcomes and treatments. RESULTS: Of 6650 participants undergoing screening, ILA were reported in 169 (2.5%) participants. Following review in a screening review meeting, 56 participants were referred to the ILD service for further evaluation (0.8% of all screening participants). 2 participants declined referral, 1 is currently awaiting review and the remaining 53 were confirmed as having ILD. Eventual diagnoses were idiopathic pulmonary fibrosis (n=14), respiratory bronchiolitis ILD (n=4), chronic hypersensitivity pneumonitis (n=2), connective tissue disease/rheumatoid arthritis-related ILD (n=4), asbestosis (n=1), idiopathic non-specific interstitial pneumonia (n=1), sarcoidosis (n=1) and pleuroparenchymal fibroelastosis (n=1). Twenty five patients had unclassifiable idiopathic interstitial pneumonia. Overall, 10 people received pharmacotherapy (7 antifibrotics and 3 prednisolone) representing 18% of those referred to the ILD service and 0.15% of those undergoing screening. 32 people remain under surveillance in the ILD service, some of whom may require treatment in future. DISCUSSION: Lung cancer screening detects clinically significant cases of ILD allowing early commencement of disease-modifying treatment in a proportion of participants. This is the largest screening cohort to report eventual diagnoses and treatments and provides an estimate of the level of clinical activity to be expected by ILD services as lung cancer screening is implemented. Further research is needed to clarify the optimal management of screen-detected ILD. TRIAL REGISTRATION NUMBER: ISRCTN42704678.

Diagnosis and treatment outcomes from prebronchodilator spirometry performed alongside lung cancer screening in a Lung Health Check programme.

INTRODUCTION: Incorporating spirometry into low-dose CT (LDCT) screening for lung cancer may help identify people with undiagnosed chronic obstructive pulmonary disease (COPD), although the downstream impacts are not well described. METHODS: Participants attending a Lung Health Check (LHC) as part of the Yorkshire Lung Screening Trial were offered spirometry alongside LDCT screening. Results were communicated to the general practitioner (GP), and those with unexplained symptomatic airflow obstruction (AO) fulfilling agreed criteria were referred to the Leeds Community Respiratory Team (CRT) for assessment and treatment. Primary care records were reviewed to determine changes to diagnostic coding and pharmacotherapy. RESULTS: Of 2391 LHC participants undergoing prebronchodilator spirometry, 201 (8.4%) fulfilled the CRT referral criteria of which 151 were invited for further assessment. Ninety seven participants were subsequently reviewed by the CRT, 46 declined assessment and 8 had already been seen by their GP at the time of CRT contact. Overall 70 participants had postbronchodilator spirometry checked, of whom 20 (29%) did not have AO. Considering the whole cohort referred to the CRT (but excluding those without AO postbronchodilation), 59 had a new GP COPD code, 56 commenced new pharmacotherapy and 5 were underwent pulmonary rehabilitation (comprising 2.5%, 2.3% and 0.2% of the 2391 participants undergoing LHC spirometry). CONCLUSIONS: Delivering spirometry alongside lung cancer screening may facilitate earlier diagnosis of COPD. However, this study highlights the importance of confirming AO by postbronchodilator spirometry prior to diagnosing and treating patients with COPD and illustrates some downstream challenges in acting on spirometry collected during an LHC.

Variation in hospital cost trajectories at the end of life by age, multimorbidity and cancer type.

Background: Approximately thirty thousand people in Scotland are diagnosed with cancer annually, of whom a third live less than one year. The timing, nature and value of hospital-based healthcare for patients with advanced cancer are not well understood. The study's aim was to describe the timing and nature of hospital-based healthcare use and associated costs in the last year of life for patients with a cancer diagnosis. Methods: We undertook a Scottish population-wide administrative data linkage study of hospital-based healthcare use for individuals with a cancer diagnosis, who died aged 60 and over between 2012 and 2017. Hospital admissions and length of stay (LOS), as well as the number and nature of outpatient and day case appointments were analysed. Generalised linear models were used to adjust costs for age, gender, socioeconomic deprivation status, rural-urban (RU) status and comorbidity. Results: The study included 85,732 decedents with a cancer diagnosis. For 64,553 (75.3%) of them, cancer was the primary cause of death. Mean age at death was 80.01 (SD 8.15) years. The mean number of inpatient stays in the last year of life was 5.88 (SD 5.68), with a mean LOS of 7 days. Admission rates rose sharply in the last month of life. One year adjusted and unadjusted costs decreased with increasing age. A higher comorbidity burden was associated with higher costs. Major cost differences were present between cancer types. Conclusions: People in Scotland in their last year of life with cancer are high users of secondary care. Hospitalisation accounts for a high proportion of costs, particularly in the last month of life. Further research is needed to examine triggers for hospitalisations and to identify influenceable reasons for unwarranted variation in hospital use among different cancer cohorts.

Development and Internal Validation of a Risk Prediction Model to Identify Myeloma Based on Routine Blood Tests: A Case-Control Study.

Myeloma is one of the hardest cancers to diagnose in primary care due to its rarity and non-specific symptoms. A rate-limiting step in diagnosing myeloma is the clinician considering myeloma and initiating appropriate investigations. We developed and internally validated a risk prediction model to identify those with a high risk of having undiagnosed myeloma based on results from routine blood tests taken for other reasons. A case-control study, based on 367 myeloma cases and 1488 age- and sex-matched controls, was used to develop a risk prediction model including results from 15 blood tests. The model had excellent discrimination (C-statistic 0.85 (95%CI 0.83, 0.89)) and good calibration (calibration slope 0.87 (95%CI 0.75, 0.90)). At a prevalence of 15 per 100,000 population and a probability threshold of 0.4, approximately 600 patients would need additional reflex testing to detect one case. We showed that it is possible to combine signals and abnormalities from several routine blood test parameters to identify individuals at high-risk of having undiagnosed myeloma who may benefit from additional reflex testing. Further work is needed to explore the full potential of such a strategy, including whether it is clinically useful and cost-effective and how to make it ethically acceptable.

Meta-analysis: Enhanced liver fibrosis test to identify hepatic fibrosis in chronic liver diseases.

BACKGROUND & AIMS: Patients with liver disease can be stratified for risk of liver-related ill health by degree of hepatic fibrosis. The Enhanced liver fibrosis (ELF) test was developed to quantify hepatic fibrosis non-invasively and is widely used. The objective of this review was to identify and synthesise the evidence on the diagnostic accuracy of the ELF test for staging of hepatic fibrosis. APPROACH & RESULTS: Searches of PubMed and EMBASE were conducted between October 2020 and November 2021 to identify studies reporting the diagnostic accuracy of the ELF test compared to histology in liver disease patients. QUADAS-2 was used to assess risk of bias in each study. Meta-analysis using the multiple thresholds model described by Steinhauser S, Schumacher M, Rücker G. Modelling multiple thresholds in meta-analysis of diagnostic test accuracy studies. BMC Med. Res. Methodol. 2016;16. 10.1186/s12874-016-0196-1 allowed synthesis of 2 × 2 data at different cut-offs. Sixty-three studies were included in this review. These studies included 19,285 patients with or at risk of liver disease from viral hepatitis, Non-Alcoholic Fatty Liver Disease, Alcohol-related Liver Disease and other mixed chronic liver diseases. The prevalence of significant fibrosis, advanced fibrosis and cirrhosis was 47.5%, 39.2% and 4.4%, respectively. Cut-offs with maximal Youden index were generated with AUROC = 0.811 (95% CI: 0.736-0.870), 0.812 (95% CI: 0.758-0.856) and 0.810 (95% CI: 0.694-0.888) to detect significant fibrosis, advanced fibrosis or cirrhosis, respectively. Diagnostic accuracy of the ELF test varied between different liver diseases and cut-offs to detect each stage with 95% sensitivity or specificity were also generated. CONCLUSIONS: Meta-analysis revealed considerable variability in the ability of ELF to stage fibrosis across disease aetiologies. Research has mostly focused on viral hepatitis and NAFLD. There is currently a lack of data on the value of the ELF test in Alcohol-related liver disease and patients in primary care settings.

Procalcitonin Evaluation of Antibiotic Use in COVID-19 Hospitalised Patients (PEACH): Protocol for a Retrospective Observational Study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel virus responsible for the coronavirus disease 2019 (COVID-19) pandemic. Although COVID-19 is a viral illness, many patients admitted to hospital are prescribed antibiotics, based on concerns that COVID-19 patients may experience secondary bacterial infections, and the assumption that they may respond well to antibiotic therapy. This has led to an increase in antibiotic use for some hospitalised patients at a time when accumulating antibiotic resistance is a major global threat to health. Procalcitonin (PCT) is an inflammatory marker measured in blood samples and widely recommended to help diagnose bacterial infections and guide antibiotic treatment. The PEACH study will compare patient outcomes from English and Welsh hospitals that used PCT testing during the first wave of the COVID-19 pandemic with those from hospitals not using PCT. It will help to determine whether, and how, PCT testing should be used in the NHS in future waves of COVID-19 to protect patients from antibiotic overuse. PEACH is a retrospective observational cohort study using patient-level clinical data from acute hospital Trusts and Health Boards in England and Wales. The primary objective is to measure the difference in antibiotic use between COVID-19 patients who did or did not have PCT testing at the time of diagnosis. Secondary objectives include measuring differences in length of stay, mortality, intensive care unit admission, and resistant bacterial infections between these groups.

Perceived feasibility, facilitators and barriers to incorporating point-of-care testing for SARS-CoV-2 into emergency medical services by ambulance service staff: a survey-based approach.

OBJECTIVES: This body of work aimed to elicit ambulance service staff's perceptions on the barriers and facilitators to adoption, and clinical utility of incorporating rapid SARS-CoV-2 testing during ambulance assessments. DESIGN: A mixed-methods survey-based project using a framework analysis method to organise qualitative data. SETTING: Emergency and non-emergency care ambulatory services in the UK were approached to take part. PARTICIPANTS: Current, practising members of the UK ambulance service (paramedics, technicians, assistants and other staff) were included in this body of work. RESULTS: Survey 1: 226 responses were collected between 3 December 2020 and 11 January 2021, 179 (79.2%) of which were completed in full. While the majority of respondents indicated that an ambulance-based testing strategy was feasible in concept (143/190, 75.3%), major barriers to adoption were noted. Many open-ended responses cited concerns regarding misuse of the service by the general public and other healthcare services, timing and conveyance issues, and increased workloads, alongside training and safety concerns. Survey 2: 26 responses were received between 8 February 2021 and 22 February 2021 to this follow-up survey. Survey 2 revealed conveyance decision-making, and risk stratification to be the most frequently prioritised use cases among ambulance service staff. Optimal test characteristics for clinical adoption according to respondents were; accuracy (above 90% sensitivity and specificity), rapidity (<30 min time to results) and ease of sample acquisition. CONCLUSIONS: The majority of commercially available lateral flow devices are unlikely to be supported by paramedics as their duty of care requires both rapid and accurate results that can inform clinical decision making in an emergency situation. Further investigation is needed to define acceptable test characteristics and criteria required for ambulance service staff to be confident and supportive of deployment of a SARS-CoV-2 test in an emergency care setting.

An exploratory assessment of the impact of a novel risk assessment test on breast cancer clinic waiting times and workflow: a discrete event simulation model.

BACKGROUND: Breast cancer clinics across the UK have long been struggling to cope with high demand. Novel risk prediction tools - such as the PinPoint test - could help to reduce unnecessary clinic referrals. Using early data on the expected accuracy of the test, we explore the potential impact of PinPoint on: (a) the percentage of patients meeting the two-week referral target, and (b) the number of clinic 'overspill' appointments generated (i.e. patients having to return to the clinic to complete their required investigations). METHODS: A simulation model was built to reflect the annual flow of patients through a single UK clinic. Due to current uncertainty around the exact impact of PinPoint testing on standard care, two primary scenarios were assessed. Scenario 1 assumed complete GP adherence to testing, with only non-referred cancerous cases returning for delayed referral. Scenario 2 assumed GPs would overrule 20% of low-risk results, and that 10% of non-referred non-cancerous cases would also return for delayed referral. A range of sensitivity analyses were conducted to explore the impact of key uncertainties on the model results. Service reconfiguration scenarios, removing individual weekly clinics from the clinic schedule, were also explored. RESULTS: Under standard care, 66.3% (95% CI: 66.0 to 66.5) of patients met the referral target, with 1,685 (1,648 to 1,722) overspill appointments. Under both PinPoint scenarios, > 98% of patients met the referral target, with overspill appointments reduced to between 727 (707 to 746) [Scenario 1] and 886 (861 to 911) [Scenario 2]. The reduced clinic demand was sufficient to allow removal of one weekly low-capacity clinic [N = 10], and the results were robust to sensitivity analyses. CONCLUSION: The findings from this early analysis indicate that risk prediction tools could have the potential to alleviate pressure on cancer clinics, and are expected to have increased utility in the wake of heightened pressures resulting from the COVID-19 pandemic. Further research is required to validate these findings with real world evidence; evaluate the broader clinical and economic impact of the test; and to determine outcomes and risks for patients deemed to be low-risk on the PinPoint test and therefore not initially referred.

Cost-effectiveness of gasless laparoscopy as a means to increase provision of minimally invasive surgery for abdominal conditions in rural North-East India.

Laparoscopic surgery, a minimally invasive technique to treat abdominal conditions, has been shown to produce equivalent safety and efficacy with quicker return to normal function compared to open surgery. As such, it is widely accepted as a cost-effective alternative to open surgery for many abdominal conditions. However, access to laparoscopic surgery in rural North-East India is limited, in part due to limited equipment, unreliable supplies of CO2 gas, lack of surgical expertise and a shortage of anaesthetists. We evaluate the cost-effectiveness of gasless laparoscopy as a means to increase provision of minimally invasive surgery (MIS) for abdominal conditions in rural North-East India. A decision tree model was developed to compare costs, evaluated from a patient perspective, and health outcomes, disability adjusted life years (DALYs), associated with gasless laparoscopy, conventional laparoscopy or open abdominal surgery in rural North-East India. Results indicate that MIS (performed by conventional or gasless laparoscopy) is less costly and produces better outcomes, fewer DALYs, than open surgery. These results were consistent even when gasless laparoscopy was analysed using least favourable data from the literature. Scaling up provision of MIS through increased access to gasless laparoscopy would reduce the cost burden to patients and increase DALYs averted. Based on a sample of 12 facilities in the North-East region, if scale up was achieved so that all essential surgeries amenable to laparoscopic surgery were performed as such (using conventional or gasless laparoscopy), 64% of DALYS related to these surgeries could be averted, equating to an additional 454.8 DALYs averted in these facilities alone. The results indicate that gasless laparoscopy is likely to be a cost-effective alternative to open surgery for abdominal conditions in rural North-East India and provides a possible bridge to the adoption of full laparoscopic services.

Participation in community-based lung cancer screening: the Yorkshire Lung Screening Trial.

BACKGROUND: Screening with low-dose computed tomography (LDCT) reduces lung cancer mortality; however, the most effective strategy for optimising participation is unknown. Here we present data from the Yorkshire Lung Screening Trial, including response to invitation, screening eligibility and uptake of community-based LDCT screening. METHODS: Individuals aged 55-80 years, identified from primary care records as having ever smoked, were randomised prior to consent to invitation to telephone lung cancer risk assessment or usual care. The invitation strategy included general practitioner endorsement, pre-invitation and two reminder invitations. After telephone triage, those at higher risk were invited to a Lung Health Check (LHC) with immediate access to a mobile CT scanner. RESULTS: Of 44 943 individuals invited, 50.8% (n=22 815) responded and underwent telephone-based risk assessment (16.7% and 7.3% following first and second reminders, respectively). A lower response rate was associated with current smoking status (adjusted OR 0.44, 95% CI 0.42-0.46) and socioeconomic deprivation (adjusted OR 0.58, 95% CI 0.54-0.62 for the most versus the least deprived quintile). Of those responding, 34.4% (n=7853) were potentially eligible for screening and offered a LHC, of whom 86.8% (n=6819) attended. Lower uptake was associated with current smoking status (adjusted OR 0.73, 95% CI 0.62-0.87) and socioeconomic deprivation (adjusted OR 0.78, 95% CI 0.62-0.98). In total, 6650 individuals had a baseline LDCT scan, representing 99.7% of eligible LHC attendees. CONCLUSIONS: Telephone risk assessment followed by a community-based LHC is an effective strategy for lung cancer screening implementation. However, lower participation associated with current smoking status and socioeconomic deprivation underlines the importance of research to ensure equitable access to screening.

Clinical utility of small bowel ultrasound assessment of Crohn's disease in adults: a systematic scoping review.

Background: Ultrasound (US) is an alternative to magnetic resonance enterography, and has the potential to significantly reduce waiting times, expedite clinical decision-making and improve patient experience. Point of care US is an advantage of the US imaging modality, where same day scanning, interpretation and treatment decisions can be made. Aim: To systematically scope the literature on point of care US use in small bowel Crohn's disease, generating a comprehensive list of factors relating to the current understanding of clinical utility of this imaging modality. Methods: Searches included MEDLINE, EMBASE, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, clinicaltrial.gov,'TRIP' and Epistemonikos. Reference lists of included studies were hand searched. Search terms were searched for as both keywords and subject headings (MeSH) as appropriate. Searches were performed with the 'suggested search terms' and 'explode' selection, and restricted to 'human', 'adult' and 'English language' publications. No date limits were applied to be as inclusive as possible. Two investigators conducted abstract and full-text review. No formal quality appraisal process was undertaken; however, quality of sources was considered when reporting findings. A narrative synthesis was conducted. Results: The review included 42 sources from the UK, Europe, Japan, Canada and the USA. Small bowel ultrasound (SBUS) has been shown to be as accurate in detecting the presence of small bowel Crohn's disease, is quicker, safer and more acceptable to patients, compared with magnetic resonance enterography. SBUS is used widely in central Europe and Canada but has not been embraced in the UK. Further research considering economic evaluation, clinical decision-making and exploration of perceived barriers to future implementation of SBUSs is required.