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Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of in vitro diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.

Background Influenza is an acute viral infection of the respiratory tract. A rapid confirmatory diagnosis of influenza is important, since it is highly transmissible and outbreaks of influenza within the hospital setting increase morbidity and mortality. The objective of this study was to evaluate the cost implications, from the perspective of the UK NHS, of using on-label nasal swabs with the Alere™ i Influenza A & B test in a near patient setting. Methods A cost consequence model was developed. The time horizon of the model was from hospital admission on suspicion of influenza until the end of treatment (following a diagnosis of influenza or discharge from hospital). Data on the prevalence of influenza and the sensitivity and specificity of the Alere™ i Influenza A & B test came from two prospective observational diagnostic accuracy studies. Costs were obtained from published resources. Uncertainties in the model data were investigated using deterministic, one-way sensitivity analyses. Results Using the Alere™ i Influenza A & B point of care test with nasal swabs (on label) in NHS medical assessment units and emergency departments could save approximately £242,730 per 1000 adults presenting with influenza-like symptoms. The main cause for this was reduced times to availability of the result compared with the laboratory RT-PCR test. Other key drivers of savings were the cost of isolation, the prevalence of influenza, the specificity of the test, and the availability of isolation resources. Conclusions The Alere™ i Influenza A & B point of care test would have greatest impact in hospitals that have extensive delays in the time to receive a result. Sensitivity analyses identified the model parameters which would have greatest effect on the result and confirmed that assumptions were conservative, i.e. did not change key results.

Reason for the studyTo standardize the use of flow cytometry for classifying hematological malignancies and make the results reliable and reproducible across laboratories, the EuroFlow™ Consortium published a comprehensive specification of antibody‐fluorochrome conjugates, standard protocols, and algorithms for analysis. The BD OneFlow™ system builds on, and further standardizes, the EuroFlow protocols. We aimed to assess the effects on safety, efficiency, and costs for laboratories of adopting the BD OneFlow reagent tubes (LST and B‐CLPD T1) for diagnosing chronic lymphocytic leukemia.MethodsWe compared in‐house laboratory processes and results with those using the LST and B‐CLPD T1 reagent tubes with, and without, blood film morphology. Outcome measures included concordance in classification results, and efficiency within the laboratory, that is, resource usage, staff time, unwanted events, and cost‐consequences.ResultsThere was 100% concordance between the classifications made with in‐house flow cytometry and those with the BD OneFlow reagent tubes. Using BD OneFlow tubes required 13 hours less staff time per month (i.e. for 100 samples) than the in‐house process. Sensitivity analyses explored the effects of uncertainties in the price of the BD OneFlow tubes and the prevalence of CLL and identified the thresholds at which laboratories might expect cost‐savings from adopting the BD OneFlow system. Laboratory and clinical staff considered the BD OneFlow system to be safe and effective.ConclusionsLaboratories adopting the BD OneFlow system for classifying patients with suspected CLL can expect safe, efficient processes that can be cost saving if the discount on the list price, and prevalence of CLL (which will both vary between sites and countries), is within the thresholds suggested by the health economics sensitivity analysis. © 2019 International Clinical Cytometry Society

ObjectiveTo assess the value added to the National Early Warning Score (NEWS) by mid-regional pro-adrenomedullin (MR-proADM) blood level in predicting deterioration in mild to moderately ill people.DesignProspective observational study.SettingThe Medical Admissions Suite of the Royal Victoria Infirmary, Newcastle.Participants300 adults with NEWS between 2 and 5 on admission. Exclusion criteria included receiving palliative care, or admitted for social reasons or self-harming. Patients were enrolled between September and December 2015, and followed up for 30 days after discharge.Outcome measureThe primary outcome measure was the proportion of patients who, within 72 hours, had an acuity increase, defined as any combination of an increase of at least 2 in the NEWS; transfer to a higher-dependency bed or monitored area; death; or for those discharged from hospital, readmission for medical reasons.ResultsNEWS and MR-proADM together predicted acuity increase more accurately than NEWS alone, increasing the area under the curve (AUC) to 0.61 (95% CI 0.54 to 0.69) from 0.55 (95% CI 0.48 to 0.62). When the confounding effects of presence of chronic obstructive pulmonary disease or heart failure and interaction with MR-proADM were included, the prognostic accuracy further increased the AUC to 0.69 (95% CI 0.63 to 0.76).ConclusionsMR-proADM is potentially a clinically useful biomarker for deterioration in patients admitted to hospital with a mild to moderately severe acute illness, that is, with NEWS between 2 and 5. As a growing number of National Health Service hospitals are routinely recording the NEWS on their clinical information systems, further research should assess the practicality and use of developing a decision aid based on admission NEWS, MR-proADM level, and possibly other clinical data and other biomarkers that could further improve prognostic accuracy.

ObjectivesTo evaluate the impact of introducing CT fractional flow reserve (FFRCT) on stable chest pain pathways, concordance with National Institute for Health and Care Excellence (NICE) chest pain guidelines, resource usage and revascularisation of patients from a tertiary UK cardiac centre rapid access chest pain clinic (RACPC).MethodsSingle-centre before and after study comparing data from electronic records and Strategic Tracing Service of all RACPC patients attending between 1 July 2017 and 31 December 2017, and 1 August 2018 and 31 January 2019.ResultsTwo hundred and sixty-eight and 287 patients (overall mean age 62 years, range 26–89 years, 48.3% male), were eligible for first-line CT coronary angiography (CTCA) pre-FFRCTand post-FFRCT, respectively. First-line CTCA use per NICE Guideline CG95 increased (50.6% pre-FFRCTvs 75.7% post-FFRCT, p<0.001). More patients reached pathway endpoint (revascularisation or assumed medical management) after one investigation (74.9% pre-FFRCTvs 84.9% post-FFRCT, p=0.005). There were fewer stress (22.8% pre-FFRCTvs 7.7% post-FFRCT, p<0.001) and rest (10.4% pre-FFRCTvs 4.2% post-FFRCT, p=0.007) myocardial perfusion scans and diagnostic-only angiograms (25.5% vs 13.7%, p<0.001). Despite fewer invasive procedures (29.3% pre-FFRCTvs 17.6% post-FFRCT, p=0.002), revascularisation rates remained similar (10.4% pre-FFRCTvs 8.8% post-FFRCT, p=0.561). Avoiding invasive investigations reduced inpatient admissions (39.0% pre-FFRCTvs 24.3% post-FFRCT, p<0.001). Time to revascularisation was unchanged (153.5 days pre-FFRCTvs 142.0 post-FFRCT, p=0.925). Unplanned hospital attendances, emergency admissions and adverse events were similar.ConclusionsFFRCTadoption was associated with greater compliance with NICE guidelines, reduced invasive diagnostic angiography, planned admissions and needing more than one test to reach a pathway endpoint.

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