How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

Graziadio, Sara; Winter, Amanda; Lendrem, Clare; Suklan, Jana; Jones, William S.; Urwin, Samuel; O’Leary, Rachel; Dickinson, Rachel; Halstead, Anna; Kurowska, K.; Green, Kile; Sims, Andrew; Simpson, A. John; Power, HM; Allen, Joy

doi:10.3390/mi11030291

Cited by 22 publications

(20 citation statements)

References 38 publications

(49 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, before a biomarker to be recommended for clinical practice, it should be evaluated for analytical, clinical, and internal validity. Moreover, external validation and clinical utility are desirable [28,31,32].…”

Section: Discussionmentioning

confidence: 99%

Diagnostic Accuracy with Total Adenosine Deaminase as a Biomarker for Discriminating Pleural Transudates and Exudates in a Population-Based Cohort Study

et al. 2021

View full text Add to dashboard Cite

Background. An initial step in the evaluation of patients with pleural effusion syndrome (PES) is to determine whether the pleural fluid is a transudate or an exudate. Objectives. To investigate total adenosine deaminase (ADA) as a biomarker to classify pleural transudates and exudates. Methods. An assay of total ADA in pleural fluids (P-ADA) was observed using a commercial kit in a population-based cohort study. Results. 157 pleural fluid samples were collected from untreated individuals with PES due to several causes. The cause most prevalent in transudate samples (21%, n = 33 / 157 ) was congestive heart failure (79%, 26/33) and that among exudate samples (71%, n = 124 / 157 ) was tuberculosis (28.0%, 44/124). There was no significant difference in the proportion of either sex between the transudate and exudate groups. The median values of P-ADA were significantly different ( P < 0.0001 ) between both total exudates (18.4 U/L; IQR, 9.85-41.4) and exudates without pleural tuberculosis (11.0 U/L; IQR, 7.25-19.75) and transudates (6.85; IQR, 2.67-11.26). For exudates, the AUC was 0.820 (95% CI, 0.751-0.877; P < 0.001 ), with excellent discrimination. The optimum cut-off point in the ROC curve was determined as the level that provided the maximum positive likelihood ratio (PLR; 14.64; 95% CI, 2.11-101.9) and was22.0 U/L. For transudates, the AUC was 0.8245 (95% CI, 0.7470-0.9020; P < 0.0001 ). Internal validation of the AUC after 1000 resamples was evaluated with a tolerance minor than 2%. The clinical utility was equal to 92% (95% CI, 0.84 to 0.96, P < 0.05 ).Conclusions. P-ADA is a useful biomarker for distinguishing pleural exudates from transudates.

show abstract

Section: Discussionmentioning

confidence: 99%

Diagnostic Accuracy with Total Adenosine Deaminase as a Biomarker for Discriminating Pleural Transudates and Exudates in a Population-Based Cohort Study

et al. 2021

View full text Add to dashboard Cite

show abstract

“…[16] This work instead took a different approach with a focus on drawing a broad, high-level picture of the pathway across the UK, whilst describing the differences across hospitals descriptively. This pathway was useful to inform economic modelling from a national perspective, as well as the study design of clinical evaluations of new diagnostics and POC tests [8] with the CONDOR platform (https://www.condor-platform.org/).…”

Section: Discussionmentioning

confidence: 99%

“…There is pressure to expedite test development and evaluation, and the demand on developing models to help identify optimal testing strategies is also high. Patient care pathway analysis [7] is the rst step in that direction, [8] supporting the identi cation of the most effective role of new tests in the current care pathway.…”

Section: Introductionmentioning

confidence: 99%

Care Pathway And Prioritization Of Rapid Testing For Covid-19 In UK Hospitals: A Qualitative Evaluation

Hicks

Winter

Green

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

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 hours, 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.

show abstract

“…At the core of TPP development is the scoping and definition of unmet clinical needs [ 5 ]. Tests often have numerous roles in clinical practice across multiple clinical settings (e.g., primary and secondary care) and positions in a care pathway (e.g., to diagnose or to monitor disease) [ 8 ]. There is an urgent need to identify which health and social care settings are most in need of COVID-19 tests, and the priority role(s) for tests in these settings, particularly ahead of the winter season, where other respiratory viral-like illnesses will also be in circulation.…”

Section: Introductionmentioning

confidence: 99%

Unmet clinical needs for COVID-19 tests in UK health and social care settings

et al. 2020

Self Cite

View full text Add to dashboard Cite

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.

show abstract

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

Cited by 22 publications

References 38 publications

Diagnostic Accuracy with Total Adenosine Deaminase as a Biomarker for Discriminating Pleural Transudates and Exudates in a Population-Based Cohort Study

Diagnostic Accuracy with Total Adenosine Deaminase as a Biomarker for Discriminating Pleural Transudates and Exudates in a Population-Based Cohort Study

Care Pathway And Prioritization Of Rapid Testing For Covid-19 In UK Hospitals: A Qualitative Evaluation

Unmet clinical needs for COVID-19 tests in UK health and social care settings

Contact Info

Product

Resources

About