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3. Bayesian sample size determination for diagnostic accuracy studies

Author

Wilson, Kevin J., Williamson, S. Faye, Allen, A. Joy, Williams, Cameron J., Hellyer, Thomas P., and Lendrem, B. Clare

Subjects
Statistics - Methodology, Statistics - Applications
Abstract

The development of a new diagnostic test ideally follows a sequence of stages which, amongst other aims, evaluate technical performance. This includes an analytical validity study, a diagnostic accuracy study and an interventional clinical utility study. Current approaches to the design and analysis of the diagnostic accuracy study can suffer from prohibitively large sample sizes and interval estimates with undesirable properties. In this paper, we propose a novel Bayesian approach which takes advantage of information available from the analytical validity stage. We utilise assurance to calculate the required sample size based on the target width of a posterior probability interval and can choose to use or disregard the data from the analytical validity study when subsequently inferring measures of test accuracy. Sensitivity analyses are performed to assess the robustness of the proposed sample size to the choice of prior, and prior-data conflict is evaluated by comparing the data to the prior predictive distributions. We illustrate the proposed approach using a motivating real-life application involving a diagnostic test for ventilator associated pneumonia. Finally, we compare the properties of the proposed approach against commonly used alternatives. The results show that by making better use of existing data from earlier studies, the assurance-based approach can not only reduce the required sample size when compared to alternatives, but can also produce more reliable sample sizes for diagnostic accuracy studies., Comment: Revision: submitted to Statistics in Medicine

Published
2021

7. Conducting invasive urodynamics in primary care: qualitative interview study examining experiences of patients and healthcare professionals

Author

Milosevic, Sarah, Joseph-Williams, Natalie, Pell, Bethan, Cain, Elizabeth, Hackett, Robyn, Murdoch, Ffion, Ahmed, Haroon, Allen, A. Joy, Bray, Alison, Clarke, Samantha, Drake, Marcus J., Drinnan, Michael, Hood, Kerenza, Schatzberger, Tom, Takwoingi, Yemisi, Thomas-Jones, Emma, White, Raymond, Edwards, Adrian, and Harding, Chris

Published
2021
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9. Biomarker-guided antibiotic stewardship in suspected ventilator-associated pneumonia (VAPrapid2): a randomised controlled trial and process evaluation

Author

Hellyer, Thomas P, McAuley, Daniel F, Walsh, Timothy S, Anderson, Niall, Conway Morris, Andrew, Singh, Suveer, Dark, Paul, Roy, Alistair I, Perkins, Gavin D, McMullan, Ronan, Emerson, Lydia M, Blackwood, Bronagh, Wright, Stephen E, Kefala, Kallirroi, O'Kane, Cecilia M, Baudouin, Simon V, Paterson, Ross L, Rostron, Anthony J, Agus, Ashley, Bannard-Smith, Jonathan, Robin, Nicole M, Welters, Ingeborg D, Bassford, Christopher, Yates, Bryan, Spencer, Craig, Laha, Shondipon K, Hulme, Jonathan, Bonner, Stephen, Linnett, Vanessa, Sonksen, Julian, Van Den Broeck, Tina, Boschman, Gert, Keenan, DW James, Scott, Jonathan, Allen, A Joy, Phair, Glenn, Parker, Jennie, Bowett, Susan A, and Simpson, A John

Published
2020
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10. Eliciting hospital staff preferences for an innovative security model of practice to prevent occupational violence in healthcare settings: A qualitative study to select attributes for inclusion in a discrete choice experiment

Author

Hettiarachchi, Ruvini M., primary, Kularatna, Sanjeewa, additional, Allen, Michelle Joy, additional, Senanayake, Sameera Jayan, additional, Brain, David, additional, Griffiths, Joanna, additional, Olsson, Lita, additional, Duff, Jed, additional, and Tyack, Zephanie, additional

Published
2023
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12. Non-equilibrium and finite temperature trapped Bose gases : interactions and decay of macroscopic excitations

Author

Allen, Ashleigh Joy

Subjects
535.2
Abstract

In this thesis we study the dynamics of dark solitons, vortices and Josephson effects, in trapped atomic Bose-Einstein condensates. We firstly demonstrate a novel, sound mediated, long-range interaction mechanism between dark solitons using the Gross-Pitaevskii equation. Then we present the effect of finite temperatures on the dynamics of vortices and Josephson effects using a generalised form of this equation, which additionally includes a source term modelling the coupling of the condensate to a fully dynamical thermal cloud, described by a quantum Boltzmann equation. The latter formalism is known as the Zaremba-Nikuni-Griffin scheme (ZNG). The sound-mediated interaction between dark solitons is such that the speed and trajectory of one soliton in a condensate confined by a harmonic trap can be significantly modified by the presence of a second soliton in the same trap. By confining the two solitons to spatially separated subregions of a double well trap, we show how this effect can be magnified. In particular we find it can be large, and therefore detectable, in experimentally relevant geometries, including high-periodicity optical lattices in which the ability of solitons to act as both absorbers and emitters of energy becomes apparent. At finite temperatures, we model the dynamics via the ZNG scheme. Firstly, we give a detailed description of the scheme for numerically solving these coupled equations including all collisional terms. Then we study the effect of a dynamical thermal cloud on vortex dynamics, in particular, focussing on the experimentally-relevant quantities of precession frequencies, decay rates and vortex core brightness. The changes in these are found to increase with increasing temperature for a pancake-shaped geometry, in particular for trapping parameters of a recent experiment of Freilich et al. (Science 329, 1182 (2010)). Particle exchanging collisions between the condensate and thermal cloud are found to be crucial in determining the rate of decay of a precessing vortex. We further show that, rotation of the thermal cloud can be a mechanism for radially translating the position of a vortex, a scenario under current investigation. Finally, we analyse the effect of finite temperatures on population dynamics in a double well atom chip experiment by LeBlanc et al. (Phys. Rev. Lett. 106, 025302 (2011)). Focussing on the coupled evolution in the absence of collisions, we find that it generates significant damping which is, however, less than that observed in the experiment. A detailed comparison in the presence of collisions is beyond the scope of this thesis.

Published
2012

13. At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR-based tests? A systematic review of individual participant data

Author

Mallett, Sue, Allen, A. Joy, Graziadio, Sara, Taylor, Stuart A., Sakai, Naomi S., Green, Kile, Suklan, Jana, Hyde, Chris, Shinkins, Bethany, Zhelev, Zhivko, Peters, Jaime, Turner, Philip J., Roberts, Nia W., di Ruffano, Lavinia Ferrante, Wolff, Robert, Whiting, Penny, Winter, Amanda, Bhatnagar, Gauraang, Nicholson, Brian D., and Halligan, Steve

Published
2020
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15. A high-resolution melt curve toolkit to identify lineage-defining SARS-CoV-2 mutations.

Author

Fraser, Alice J., Greenland-Bews, Caitlin, Kelly, Daniel, Williams, Christopher T., LSTM Diagnostics Group, Bengey, Daisy, Buist, Kate, Clerkin, Karina, Finch, Lorna S, Gould, Susan, Kontogianni, Konstantina, Savage, Helen R, Thompson, Caitlin R, Wardale, Jahanara, Watkins, Rachel L, Wooding, Dominic, CONDOR Steering Group, Allen, A. Joy, Body, Richard, and Braybrook, Julian

Subjects
SARS-CoV-2, WHOLE genome sequencing, SARS-CoV-2 Omicron variant
Abstract

The emergence of severe acute respiratory syndrome 2 (SARS-CoV-2) variants of concern (VOCs), with mutations linked to increased transmissibility, vaccine escape and virulence, has necessitated the widespread genomic surveillance of SARS-CoV-2. This has placed a strain on global sequencing capacity, especially in areas lacking the resources for large scale sequencing activities. Here we have developed three separate multiplex high-resolution melting assays to enable the identification of Alpha, Beta, Delta and Omicron VOCs. The assays were evaluated against whole genome sequencing on upper-respiratory swab samples collected during the Alpha, Delta and Omicron [BA.1] waves of the UK pandemic. The sensitivities of the eight individual primer sets were all 100%, and specificity ranged from 94.6 to 100%. The multiplex HRM assays have potential as a tool for high throughput surveillance of SARS-CoV-2 VOCs, particularly in areas with limited genomics facilities. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation

Author

Micocci, Massimo, primary, Buckle, Peter, additional, Hayward, Gail, additional, Allen, A Joy, additional, Davies, Kerrie, additional, Kierkegaard, Patrick, additional, Spilsbury, Karen, additional, Thompson, Carl, additional, Astle, Anita, additional, Heath, Ros, additional, Sharpe, Claire, additional, Akrill, Cyd, additional, Lasserson, Dan, additional, Perera, Rafael, additional, Body, Richard, additional, and Gordon, Adam L, additional

Published
2021
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18. Managing LUTS in primary care: qualitative study of GPs’ and patients’ experiences

Author

Milosevic, Sarah, Joseph-Williams, Natalie, Pell, Bethan, Cain, Elizabeth, Hackett, Robyn, Murdoch, Ffion, Ahmed, Haroon, Allen, A. Joy, Bray, Alison, Thomas-Jones, Emma, Harding, Chris, and Edwards, Adrian

Abstract

Background: Lower urinary tract symptoms (LUTS) are common in older men and impact considerably on their quality of life. Management can be complex, and although most LUTS could be treated effectively in primary care, referrals to urology outpatients are increasing. The experiences of General Practitioners (GPs) and patients relating to the management of LUTS have not yet been fully explored. Aim: To explore GPs’ experiences of managing LUTS, together with patients’ experiences of and preferences for treatment in primary care. Design and setting: Qualitative telephone interviews with GPs and male patients presenting to primary care with bothersome LUTS. Method: Eleven GPs and 25 male patients were purposively sampled from 20 GP practices in 3 UK regions. Interviews were conducted between May 2018 and January 2019 and analysed using a framework approach. Results: Difficulty establishing causes and differentiating between prostate and bladder symptoms were key challenges to the diagnosis of LUTS in primary care, making treatment often a process of trial and error. Pharmacological treatments were commonly ineffective and often caused side-effects. Despite this, patients were generally satisfied with GP consultations and expressed a preference for treatment in primary care. Conclusion: Managing LUTS in primary care is a more accessible option for patients. Given the challenges of LUTS diagnosis, an effective diagnostic tool for use by GPs would be beneficial. Ensuring bothersome LUTS are not dismissed as a normal part of ageing is essential in improving patients’ quality of life. Greater exploration of the role of non-pharmacological treatments is needed.

Published
2021

19. Managing lower urinary tract symptoms in primary care: qualitative study of GPs’ and patients’ experiences

Author

Milosevic, Sarah, primary, Joseph-Williams, Natalie, additional, Pell, Bethan, additional, Cain, Elizabeth, additional, Hackett, Robyn, additional, Murdoch, Ffion, additional, Ahmed, Haroon, additional, Allen, A Joy, additional, Bray, Alison, additional, Thomas-Jones, Emma, additional, Harding, Chris, additional, and Edwards, Adrian, additional

Published
2021
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22. Additional file 1 of Systematic review of studies investigating ventilator associated pneumonia diagnostics in intensive care

Author

Al-Omari, Basem, McMeekin, Peter, Allen, A. Joy, Akram, Ahsan R., Graziadio, Sara, Suklan, Jana, Jones, William S., Lendrem, B. Clare, Winter, Amanda, Cullinan, Milo, Gray, Joanne, Dhaliwal, Kevin, Walsh, Timothy S., and Craven, Thomas H.

Subjects
ComputingMethodologies_PATTERNRECOGNITION, InformationSystems_INFORMATIONSTORAGEANDRETRIEVAL, Data_FILES
Abstract

Additional file 1. MEDLINE search example.

Published
2021
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24. Additional file 2 of Systematic review of studies investigating ventilator associated pneumonia diagnostics in intensive care

Author

Al-Omari, Basem, McMeekin, Peter, Allen, A. Joy, Akram, Ahsan R., Graziadio, Sara, Suklan, Jana, Jones, William S., Lendrem, B. Clare, Winter, Amanda, Cullinan, Milo, Gray, Joanne, Dhaliwal, Kevin, Walsh, Timothy S., and Craven, Thomas H.

Subjects
Data_FILES
Abstract

Additional file 2. Quality assessment and data extraction form.

Published
2021
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28. Utility of Routine Laboratory Biomarkers to Detect COVID-19: A Systematic Review and Meta-Analysis

Author

Suklan, Jana, primary, Cheaveau, James, additional, Hill, Sarah, additional, Urwin, Samuel G., additional, Green, Kile, additional, Winter, Amanda, additional, Hicks, Timothy, additional, Boath, Anna E., additional, Kernohan, Ashleigh, additional, Price, D. Ashley, additional, Allen, A. Joy, additional, Moloney, Eoin, additional, and Graziadio, Sara, additional

Published
2021
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29. Is point-of-care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-CoV-2

Author

Micocci, Massimo, primary, Gordon, Adam L, additional, Seo, Mikyung Kelly, additional, Allen, A Joy, additional, Davies, Kerrie, additional, Lasserson, Dan, additional, Thompson, Carl, additional, Spilsbury, Karen, additional, Akrill, Cyd, additional, Heath, Ros, additional, Astle, Anita, additional, Sharpe, Claire, additional, Perera, Rafael, additional, Hayward, Gail, additional, and Buckle, Peter, additional

Published
2021
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33. Randomised controlled trial and process evaluation of biomarker-guided antibiotic stewardship in suspected ventilator-associated pneumonia

Author

Hellyer, Thomas, McAuley, Daniel F, Walsh, Timothy S, Anderson, Niall, Conway Morris, Andrew, Singh, Suveer, Dark, Paul, Roy, Alistair I, Perkins, Gavin D, McMullan, Ronan, Emerson, Lydia M, Blackwood, Bronagh, Wright, Stephen E, Kefala, Kallirroi, O’Kane, Cecilia M, Baudouin, Simon V, Paterson, Ross L, Rostron, Anthony J, Agus, Ashley, Bannard-Smith, Jonathan, Robin, Nicole M, Welters, Ingeborg D, Bassford, Christopher, Yates, Bryan, Spencer, Craig, Laha, Shondipon K, Hulme, Jonathan, Bonner, Stephen, Linnett, Vanessa, Sonksen, Julian, Van Den Broeck, Tina, Boschman, Gert, Keenan, James, Scott, Jonathan, Allen, A Joy, Phair, Glenn, Parker, Jennie, Bowett, Susan A, Simpson, A John, Conway Morris, Andrew [0000-0002-3211-3216], and Apollo - University of Cambridge Repository

Subjects
Male, Process Assessment, Health Care, Pneumonia, Ventilator-Associated, Middle Aged, Bronchoalveolar Lavage, State Medicine, United Kingdom, respiratory tract diseases, Anti-Bacterial Agents, 03 medical and health sciences, Antimicrobial Stewardship, 0302 clinical medicine, 030228 respiratory system, Humans, Female, 030212 general & internal medicine, Bronchoalveolar Lavage Fluid, Biomarkers
Abstract

BACKGROUND. Ventilator-associated pneumonia (VAP) is the most common intensive care unit (ICU)-acquired infection, yet accurate diagnosis remains difficult, leading to overuse of antibiotics. Low concentrations of IL-1 and IL-8 in bronchoalveolar lavage (BAL) fluid have been validated as effective markers for excluding VAP. VAP-Rapid-2 sought to determine whether a rapid IL-1/IL-8 test could effectively and safely improve antibiotic stewardship in patients with clinically suspected VAP. METHODS. VAP-Rapid-2 was a multi-centre randomised controlled trial in 24 intensive care units in the United Kingdom. Patients with suspected VAP in 24 ICUs were randomised 1:1, via a web-based randomisation service, to a “biomarker-based recommendation on antibiotics” or “routine use of antibiotics”. Clinicians were blinded to randomisation for an initial period until the biomarker results were reported. Bronchoalveolar lavage (BAL) was performed in all patients, with concentrations of IL-1 and IL-8 rapidly determined in BAL fluid from patients randomised to the “biomarker-based antibiotic recommendation” arm. If concentrations were below a previously validated cut-off, clinicians were advised that VAP was unlikely and to consider discontinuing antibiotics. Patients in the “routine use of antibiotics” arm received antibiotics according to usual practice. Microbiology was performed on BAL fluid from all patients and VAP was confirmed by ≥104 colony forming units per mL of BAL fluid. The primary outcome measure was the distribution of antibiotic-free days (AFD) in the seven days following BAL. Data were analysed on an intention-to-treat basis, with an additional per-protocol analysis that excluded patients randomised to the intervention arm who defaulted to routine use of antibiotics due to failure to return an adequate biomarker result. An embedded process evaluation assessed factors influencing trial adoption, recruitment and decision making. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN: 65937227, and with ClinicalTrials.gov: NCT01972425. FINDINGS. The trial randomised the target number of 210 patients with suspected VAP. One patient was withdrawn by the clinical team prior to bronchoscopy and so was excluded from the intention-to-treat analysis (‘biomarker-guided recommendation on antibiotics’, n=103; ‘routine use of antibiotics’, n=106). Antibiotics were being used at baseline in 83 (n=103, 80·6%) patients in the intervention arm and 87 (n=106, 82·1%) patients in the control arm. The negative likelihood ratio of the IL-1/IL-8 test was 0·09. There was no difference in the frequency distribution of AFD at day seven (p=0·58). There were no between-group differences in AFD at day 14 (HR 1·13 [95% CI 0·83-1·54]), in AFD at day 28 (HR 1·01 [95% CI 0·73-1·40]) or in mortality at 28 days (OR 1·52 [95% CI 0·78-2·98]). BAL was associated with a small and transient increase in oxygen requirements. Established prescribing practices, reluctance for BAL, and dependence on a chain of trial-related procedures emerged as factors impairing trial processes. INTERPRETATION. Antibiotic use remains high in patients with suspected VAP. Antibiotic stewardship was not improved by a rapid, highly sensitive rule-out test. Prescribing culture, rather than poor test performance, may explain the lack of effect.

Published
2019
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35. FebriDx point-of-care test in patients with suspected COVID-19: a systematic review and individual patient data meta-analysis of diagnostic test accuracy studies

Author

Urwin, Samuel G., primary, Lendrem, B. Clare, additional, Suklan, Jana, additional, Green, Kile, additional, Graziadio, Sara, additional, Buckle, Peter, additional, Dark, Paul M., additional, Gordon, Adam L., additional, Lasserson, Daniel S., additional, Nicholson, Brian, additional, Price, D. Ashley, additional, Reynard, Charles, additional, Wilcox, Mark H., additional, Hayward, Gail, additional, Prestwich, Graham, additional, Tate, Valerie, additional, Clark, Tristan W., additional, Reddy, Raja V., additional, Houston, Hamish, additional, Gupta-Wright, Ankur, additional, John, Laurence, additional, Body, Richard, additional, and Allen, A. Joy, additional

Published
2020
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36. Cost Consequences for the NHS of Using a Two-Step Testing Method for the Detection of Clostridium difficile with a Point of Care, Polymerase Chain Reaction Test as the First Step

Author

Jones, William S., primary, Rice, Stephen, additional, Power, H. Michael, additional, Maniatopoulos, Gregory, additional, Suklan, Jana, additional, Beyer, Fiona, additional, Wilcox, Mark H., additional, Permain, Michelle, additional, Simpson, A. John, additional, Price, D. Ashley, additional, and Allen, A. Joy, additional

Published
2020
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37. At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR based tests?: A systematic review of individual participant data

Author

Mallett, Sue, primary, Allen, A. Joy, additional, Graziadio, Sara, additional, Taylor, Stuart, additional, Sakai, Naomi S, additional, Green, Kile, additional, Suklan, Jana, additional, Hyde, Chris, additional, Shinkins, Bethany, additional, Zhelev, Zhivko, additional, Peters, Jaime, additional, Turner, Philip, additional, Roberts, Nia W., additional, di Ruffano, Lavinia Ferrante, additional, Wolff, Robert, additional, Whiting, Penny, additional, Winter, Amanda, additional, Bhatnagar, Gauraang, additional, Nicholson, Brian D., additional, and Halligan, Steve, additional

Published
2020
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38. More research is required to understand factors influencing antibiotic prescribing in complex conditions like suspected ventilator-associated pneumonia

Author

Hellyer, Thomas P., primary, McAuley, Daniel F., additional, Walsh, Timothy S., additional, Anderson, Niall, additional, Conway Morris, Andrew, additional, Singh, Suveer, additional, Dark, Paul, additional, Roy, Alistair I., additional, Perkins, Gavin D., additional, McMullan, Ronan, additional, Emerson, Lydia M., additional, Blackwood, Bronagh, additional, Wright, Stephen E., additional, Kefala, Kallirroi, additional, O’Kane, Cecilia M., additional, Baudouin, Simon V., additional, Paterson, Ross L., additional, Rostron, Anthony J., additional, Agus, Ashley, additional, Bannard-Smith, Jonathan, additional, Robin, Nicole M., additional, Welters, Ingeborg D., additional, Bassford, Christopher, additional, Yates, Bryan, additional, Spencer, Craig, additional, Laha, Shondipon K., additional, Hulme, Jonathan, additional, Bonner, Stephen, additional, Linnett, Vanessa, additional, Sonksen, Julian, additional, Van Den Broeck, Tina, additional, Boschman, Gert, additional, Keenan, D. W. James, additional, Scott, Jonathan, additional, Allen, A. Joy, additional, Phair, Glenn, additional, Parker, Jennie, additional, Bowett, Susan A., additional, and Simpson, A. John, additional

Published
2020
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39. Diagnostic and economic evaluation of a point-of-care test for respiratory syncytial virus

Author

Allen, A. Joy, primary, Gonzalez-Ciscar, Andrea, additional, Lendrem, Clare, additional, Suklan, Jana, additional, Allen, Karen, additional, Bell, Ashley, additional, Baxter, Frances, additional, Crulley, Stephen, additional, Fairlie, Louise, additional, Hardy, Danielle, additional, Johnston, Louise, additional, McKenna, Joanne, additional, Richards, Nicole, additional, Shovlin, Gavin, additional, Simmister, Clare, additional, Waugh, Sheila, additional, Woodsford, Philip, additional, Graziadio, Sara, additional, Power, Michael, additional, Simpson, A. John, additional, Kumar, Prashant, additional, Eastham, Katherine, additional, and Brodlie, Malcolm, additional

Published
2020
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40. PRImary care Management of lower Urinary tract Symptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (the PriMUS study)

Author

Pell, Bethan, primary, Thomas-Jones, Emma, additional, Bray, Alison, additional, Agarwal, Ridhi, additional, Ahmed, Haroon, additional, Allen, A Joy, additional, Clarke, Samantha, additional, Deeks, Jonathan J, additional, Drake, Marcus, additional, Drinnan, Michael, additional, Dyer, Calie, additional, Hood, Kerenza, additional, Joseph-Williams, Natalie, additional, Marsh, Lucy, additional, Milosevic, Sarah, additional, Pickard, Robert, additional, Schatzberger, Tom, additional, Takwoingi, Yemisi, additional, Harding, Chris, additional, and Edwards, Adrian, additional

Published
2020
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43. Care pathway and prioritization of rapid testing for COVID-19 in UK hospitals: a qualitative evaluation.

Author

Hicks, Timothy, Winter, Amanda, Green, Kile, Kierkegaard, Patrick, Price, D. Ashley, Body, Richard, Allen, A. Joy, Graziadio, Sara, and CONDOR Steering Group

Subjects
COVID-19 testing, COVID-19 pandemic, COVID-19, MEDICAL personnel, VIRAL transmission, SPECIALTY hospitals
Abstract

Objectives: The second wave of the coronavirus pandemic is now established, occurring at a time of winter pressure on acute care in the NHS. This is likely to be more challenging then the first wave for the diagnosis of COVID-19 because of the similar symptomology with other respiratory conditions highly prevalent in winter. This study sought to understand the care pathways in place in UK NHS hospitals during the first wave (March-July 2020) for identification of patients with COVID-19 and to learn lessons to inform optimal testing strategies within the COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR).Design, Setting& Participants: Sixteen hospital-based clinicians from 12 UK NHS Trusts covering 10 different specialties were interviewed following a semi-structured topic guide. Data were coded soon after the interviews and analysed thematically.Results: We developed a diagrammatic, high-level visualisation of the care pathway describing the main clinical decisions associated with the diagnosis and management of patients with suspected COVID-19. COVID-19 testing influenced infection control considerations more so than treatment decisions. Two main features of service provision influenced the patient management significantly: access to rapid laboratory testing and the number of single occupancy rooms. If time to return of result was greater than 24 h, patients with a presumptive diagnosis would often be cohorted based on clinical suspicion alone. Undetected COVID-19 during this time could therefore lead to an increased risk of viral transmission.Conclusions: During the winter months, priority for provision of rapid testing at admission should be given to hospitals with limited access to laboratory services and single room availability. Access to rapid testing is essential for urgent decisions related to emergency surgery, maternity services and organ transplant. The pathway and prioritization of need will inform the economic modelling, clinical evaluations, and implementation of new clinical tests in UK. [ABSTRACT FROM AUTHOR]

Published
2021
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44. Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation

Author

Micocci, Massimo, Buckle, Peter, Hayward, Gail, Allen, A Joy, Davies, Kerrie, Kierkegaard, Patrick, Spilsbury, Karen, Thompson, Carl, Astle, Anita, Heath, Ros, Sharpe, Claire, Akrill, Cyd, Lasserson, Dan, Perera, Rafael, Body, Richard, and Gordon, Adam L

Abstract

Introduction Successful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of the contextual and usability factors that affect test results and minimise biosafety risks. This paper presents a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes.Methods A mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was conducted to explore biosafety issues.Results The agreement analysis was conducted on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI:1.3%−98.7%) positive agreement and 96% (95% CI: 92.5%−98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857−0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%−99.6%) positive agreement and 100% (95% CI: 63.1%−100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549−1). The dry run highlighted four main sources of contamination that led to the modification of the standard operating procedures. Simulation post-modification showed no further evidence of contamination.Conclusion Careful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

Published
2021
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46. Efficiency and Health Economic Evaluations of BD OneFlow™ Flow Cytometry Reagents for Diagnosing Chronic Lymphoid Leukemia

Author

Moloney, Eoin, primary, Watson, Helen, additional, Barge, Dawn, additional, Allen, A. Joy, additional, Carey, Peter, additional, Hislop, Jennifer, additional, Johnston, Louise, additional, Lorrison, Kate, additional, McGregor, Andrew, additional, O'Leary, Rachel A., additional, Power, Michael H., additional, Wallis, Jonathan, additional, Simpson, A. John, additional, and Greystoke, Brigit, additional

Published
2019
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47. Can mid-regional pro-adrenomedullin (MR-proADM) increase the prognostic accuracy of NEWS in predicting deterioration in patients admitted to hospital with mild to moderately severe illness? A prospective single-centre observational study

Author

Graziadio, Sara, primary, O’Leary, Rachel Amie, additional, Stocken, Deborah D, additional, Power, Michael, additional, Allen, A Joy, additional, Simpson, A John, additional, and Price, David Ashley, additional

Published
2018
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48. Unmet clinical needs for COVID-19 tests in UK health and social care settings.

Author

Graziadio, Sara, Urwin, Samuel G., Cocco, Paola, Micocci, Massimo, Winter, Amanda, Yang, Yaling, Price, D. Ashley, Messenger, Mike, Allen, A. Joy, and Shinkins, Bethany

Subjects
COVID-19 testing, PATHOLOGICAL laboratories, MEDICAL personnel, MEDICAL care, MEDICAL care surveys, ANTIBIOTIC residues, FAMILY planning
Abstract

There is an urgent requirement to identify which clinical settings are in most need of COVID-19 tests and the priority role(s) for tests in these settings to accelerate the development of tests fit for purpose in health and social care across the UK. This study sought to identify and prioritize unmet clinical needs for COVID-19 tests across different settings within the UK health and social care sector via an online survey of health and social care professionals and policymakers. Four hundred and forty-seven responses were received between 22nd May and 15th June 2020. Hospitals and care homes were recognized as the settings with the greatest unmet clinical need for COVID-19 diagnostics, despite reporting more access to laboratory molecular testing than other settings. Hospital staff identified a need for diagnostic tests for symptomatic workers and patients. In contrast, care home staff expressed an urgency for screening at the front door to protect high-risk residents and limit transmission. The length of time to test result was considered a widespread problem with current testing across all settings. Rapid tests for staff were regarded as an area of need across general practice and dental settings alongside tests to limit antibiotics use. [ABSTRACT FROM AUTHOR]

Published
2020
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