Children's visual acuity tests without professional supervision: a prospective repeated measures study.

BACKGROUND: Home visual acuity tests could ease pressure on ophthalmic services by facilitating remote review of patients. Home tests may have further utility in giving service users frequent updates of vision outcomes during therapy, identifying vision problems in an asymptomatic population, and engaging stakeholders in therapy. METHODS: Children attending outpatient clinics had visual acuity measured 3 times at the same appointment: Once by a registered orthoptist per clinical protocols, once by an orthoptist using a tablet-based visual acuity test (iSight Test Pro, Kay Pictures), and once by an unsupervised parent/carer using the tablet-based test. RESULTS: In total, 42 children were recruited to the study. The mean age was 5.6 years (range 3.3 to 9.3 years). Median and interquartile ranges (IQR) for clinical standard, orthoptic-led and parent/carer-led iSight Test Pro visual acuity measurements were 0.155 (0.18 IQR), 0.180 (0.26 IQR), and 0.300 (0.33 IQR) logMAR respectively. The iSight Test Pro in the hands of parents/carers was significantly different from the standard of care measurements (P = 0.008). In the hands of orthoptists. There was no significant difference between orthoptists using the iSight Test Pro and standard of care (P = 0.289), nor between orthoptist iSight Test Pro and parents/carer iSight Test Pro measurements (P = 0.108). CONCLUSION: This technique of unsupervised visual acuity measures for children is not comparable to clinical measures and is unlikely to be valuable to clinical decision making. Future work should focus on improving the accuracy of the test through better training, equipment/software or supervision/support.

Impact on stable chest pain pathways of CT fractional flow reserve.

OBJECTIVES: To 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). METHODS: Single-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. RESULTS: Two 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-FFRCT and post-FFRCT, respectively. First-line CTCA use per NICE Guideline CG95 increased (50.6% pre-FFRCT vs 75.7% post-FFRCT, p<0.001). More patients reached pathway endpoint (revascularisation or assumed medical management) after one investigation (74.9% pre-FFRCT vs 84.9% post-FFRCT, p=0.005). There were fewer stress (22.8% pre-FFRCT vs 7.7% post-FFRCT, p<0.001) and rest (10.4% pre-FFRCT vs 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-FFRCT vs 17.6% post-FFRCT, p=0.002), revascularisation rates remained similar (10.4% pre-FFRCT vs 8.8% post-FFRCT, p=0.561). Avoiding invasive investigations reduced inpatient admissions (39.0% pre-FFRCT vs 24.3% post-FFRCT, p<0.001). Time to revascularisation was unchanged (153.5 days pre-FFRCT vs 142.0 post-FFRCT, p=0.925). Unplanned hospital attendances, emergency admissions and adverse events were similar. CONCLUSIONS: FFRCT adoption 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.

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

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.

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

REASON FOR THE STUDY: To 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. METHODS: We 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. RESULTS: There 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. CONCLUSIONS: Laboratories 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.

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.

OBJECTIVE: To 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. DESIGN: Prospective observational study. SETTING: The Medical Admissions Suite of the Royal Victoria Infirmary, Newcastle. PARTICIPANTS: 300 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 MEASURE: The 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. RESULTS: NEWS 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). CONCLUSIONS: MR-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.

Sensory and autonomic function in the hands of patients with non-specific arm pain (NSAP) and asymptomatic office workers.

Chronic pain in the upper limb associated with repetitive movements of the arm and hand is often seen in patients in the absence of specific pathology such as epicondylitis, carpal tunnel syndrome and tenosynovitis. This condition has been given many names and will be referred to here as non-specific arm pain (NSAP). Previous work has shown elevated vibration thresholds and reduced flare suggesting a neuropathic cause for this condition. In order to examine this further the present study has assessed functions that involve both large sensory nerve fibres (vibration) and small dorsal root fibres (flare) and sympathetic fibres (vasoconstriction). NSAP patients and also a group of office workers who intensively used display screen equipment but who did not have NSAP were also studied along with an age-matched control group. In the median innervated area of the hand we measured flare responses to iontophoresis of histamine (a sensory C-fibre effect), and sympathetic vasoconstrictor responses to ice stimulation over C7. To tie in with previous studies, vibration threshold over areas of the hand innervated by the median, ulnar and radial nerves was also evaluated. All measures were carried out over both hands in each subject. Significant differences from controls were found on all three measures for the NSAP patient group and on two measures for the office workers. Flare area was reduced by 33% in the patients and by 30% in the office workers. Reflex vasoconstriction was reduced by 20% in the patient group but was not altered in office worker group. Over the median innervated area on the hand, vibration threshold was elevated by 47% in the patients and by 21% in the office workers. These results confirm previous findings showing reduced function associated with both small and large sensory fibres in the NSAP patients and additionally, for the first time, demonstrate a functional change related to sympathetic fibres. Office workers demonstrate a similar but smaller trend for reduced nerve function associated with both small and large sensory fibre function, but had no change in the sympathetic reflex.