scholarly journals “There is no magic bullet.” Considerations for the adoption of molecular chlamydia and gonorrhoea point of care tests into routine care.

2020 ◽  
Author(s):  
Sebastian Fuller ◽  
Emma Harding-Esch
Keyword(s):  
Sexual Health ◽  
Point Of Care ◽  
Clinical Effectiveness ◽  
Routine Care ◽  
Good Evidence ◽  
Magic Bullet ◽  
Value Proposition ◽  
Healthcare Settings ◽  
A Value ◽  
Point Of Care Tests

IntroductionSexually Transmitted Infections (STIs), including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem, with the majority of the disease burden in Low and Middle Income Countries. This could in part be addressed through increased access to rapid point-of-care-tests (POCTs) for infection detection and appropriate clinical management. Guidelines and criteria for the development of STI POCTs have been established, and several POCTs for CT and NG have been brought to market. Yet even those diagnostics with good evidence of clinical effectiveness often fail to be implemented and adopted into routine care. Here we review the current literature for test development and implementation alongside studies of how the Cepheid CT/NG GeneXpert POCT has been utilised in different healthcare settings, to develop a value proposition for CT/NG POCT adoption.MethodsWe review whether the Cepheid CT/NG GeneXpert fulfil the (RE)ASSURED and Target Product Profile (TPP) criteria, and present published literature reporting on the test’s implementation, to demonstrate its range of values in different settings and to a variety of stakeholders. This information is then applied to the value proposition for laboratory medicine, to form the basis of a value proposition for a CT/NG POCT. ResultsThe Cepheid CT/NG GeneXpert did not fulfil all (RE)ASSURED or TPP criteria, however, studies of test implementation showed multiple stakeholder values for the use of the test across various healthcare settings and geographic locations. The majority of values identified were setting specific. Sexual health services and outreach services had the least overlap in values, whereas General Practice and other non-sexual health specialist services served as a “bridge” between the two.ConclusionWe recommend that those wishing to improve CT/NG diagnosis be supported to identify the values most relevant to their settings and context, and prioritise implementation of those tests most closely aligned with those values.

scholarly journals Molecular chlamydia and gonorrhoea point of care tests implemented into routine practice: Systematic review and value proposition development

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259593
Author(s):  
Sebastian S. Fuller ◽  
Eleanor Clarke ◽  
Emma M. Harding-Esch
Keyword(s):  
Systematic Review ◽  
Sexual Health ◽  
Point Of Care ◽  
Clinical Effectiveness ◽  
Routine Care ◽  
Routine Practice ◽  
Value Proposition ◽  
Sexually Transmitted ◽  
Conference Abstract ◽  
Point Of Care Tests

Background Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings. Methods We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings. Findings The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a “bridge” between the two. Conclusions Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.

USING CLAIMS DATA FOR EVIDENCE GENERATION IN MANAGED ENTRY AGREEMENTS

2016 ◽  
Vol 32 (1-2) ◽  
pp. 69-77 ◽  
Author(s):  
Alina Brandes ◽  
Larissa Schwarzkopf ◽  
Wolf H. Rogowski
Keyword(s):  
Claims Data ◽  
Reliability And Validity ◽  
Clinical Information ◽  
Clinical Effectiveness ◽  
Routine Care ◽  
Data Availability ◽  
A Value ◽  
Sufficient Detail ◽  
Managed Entry Agreements ◽  
German Statutory Health Insurance

Objectives: This study assesses the use of routinely collected claims data for managed entry agreements (MEA) in the illustrative context of German statutory health insurance (SHI) funds.Methods: Based on a nonsystematic literature review, the data needs of different MEA were identified. A value-based typology to classify MEA on the basis of these data needs was developed. The typology is oriented toward health outcomes and utilization and costs, key components of a new technology's value. For each MEA type, the suitability of claims data in establishing evidence of the novel technology's value in routine care was systematically assessed. Assessment criteria were data availability, completeness, timeliness, confidentiality, reliability, and validity.Results: Claims data are better suited to MEA addressing uncertainty regarding the utilization and costs of a novel technology in routine care. In schemes where safety aspects or clinical effectiveness are assessed, the role of claims data is limited because clinical information is not included in sufficient detail.Conclusions: The suitability of claims data depends on the source of uncertainty and, in consequence, the outcome measures chosen in the agreements. In all schemes, the validity of claims data should be judged with caution as data are collected for billing purposes. This framework may support manufacturers and payers in selecting the most suitable contract type and agreeing on contract conditions. More research is necessary to validate these results and to address remaining medical, economic, legal, and ethical questions of using claims data for MEA.

2017 European guideline for the screening, prevention and initial management of hepatitis B and C infections in sexual health settings

2018 ◽  
Vol 29 (10) ◽  
pp. 949-967 ◽  
Author(s):  
Gary Brook ◽  
Norbert Brockmeyer ◽  
Thijs van de Laar ◽  
Sven Schellberg ◽  
Andrew J Winter
Keyword(s):  
Hepatitis B ◽  
Sexual Health ◽  
Point Of Care ◽  
Sexual Transmission ◽  
Hepatitis E ◽  
European Guideline ◽  
Virus Infections ◽  
Initial Management ◽  
Exposure Prophylaxis ◽  
Point Of Care Tests

This guideline updates the 2010 European guideline for the management of hepatitis B and C virus infections. It is primarily intended to provide advice on testing, prevention and initial management of viral hepatitis B and C for clinicians working in sexual health clinical settings in European countries. The guideline is in a new question and answer format based on clinical situations, from which population/intervention/comparison/outcome questions were formulated. Updates cover areas such as epidemiology, point-of-care tests for hepatitis B, hepatitis C risk and ‘chemsex’, and HIV pre-exposure prophylaxis and hepatitis B. We have also included a short paragraph on hepatitis E noting there is no evidence for sexual transmission. The guideline has been prepared in accordance with the Europe protocol for production available at http://www.iusti.org/regions/europe/pdf/2017/ProtocolForProduction2017.pdf

scholarly journals Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation

2017 ◽  
Vol 93 (6) ◽  
pp. 424-429 ◽  
Author(s):  
Emma M Harding-Esch ◽  
Achyuta V Nori ◽  
Aseel Hegazi ◽  
Marcus J Pond ◽  
Olanike Okolo ◽  
...  
Keyword(s):  
Sexual Health ◽  
Care Pathway ◽  
Point Of Care ◽  
Clinical Care ◽  
Service Evaluation ◽  
Multiple Point ◽  
Clinical Care Pathway ◽  
Point Of Care Tests

scholarly journals Modelling of hypothetical SARS-CoV-2 point-of-care tests on admission to hospital from A&E: rapid cost-effectiveness analysis

2021 ◽  
Vol 25 (21) ◽  
pp. 1-68
Author(s):  
Matt Stevenson ◽  
Andrew Metry ◽  
Michael Messenger
Keyword(s):  
Cost Effectiveness ◽  
Patient Outcomes ◽  
Point Of Care ◽  
Clinical Effectiveness ◽  
Decision Makers ◽  
Target Product ◽  
Target Product Profile ◽  
Point Of Care Test ◽  
Product Profile ◽  
Point Of Care Tests

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019. At the time of writing (October 2020), the number of cases of COVID-19 had been approaching 38 million and more than 1 million deaths were attributable to it. SARS-CoV-2 appears to be highly transmissible and could rapidly spread in hospital wards. Objective The work undertaken aimed to estimate the clinical effectiveness and cost-effectiveness of viral detection point-of-care tests for detecting SARS-CoV-2 compared with laboratory-based tests. A further objective was to assess occupancy levels in hospital areas, such as waiting bays, before allocation to an appropriate bay. Perspective/setting The perspective was that of the UK NHS in 2020. The setting was a hypothetical hospital with an accident and emergency department. Methods An individual patient model was constructed that simulated the spread of disease and mortality within the hospital and recorded occupancy levels. Thirty-two strategies involving different hypothetical SARS-CoV-2 tests were modelled. Recently published desirable and acceptable target product profiles for SARS-CoV-2 point-of-care tests were modelled. Incremental analyses were undertaken using both incremental cost-effectiveness ratios and net monetary benefits, and key patient outcomes, such as death and intensive care unit care, caused directly by COVID-19 were recorded. Results A SARS-CoV-2 point-of-care test with a desirable target product profile appears to have a relatively small number of infections, a low occupancy level within the waiting bays, and a high net monetary benefit. However, if hospital laboratory testing can produce results in 6 hours, then the benefits of point-of-care tests may be reduced. The acceptable target product profiles performed less well and had lower net monetary benefits than both a laboratory-based test with a 24-hour turnaround time and strategies using data from currently available SARS-CoV-2 point-of-care tests. The desirable and acceptable point-of-care test target product profiles had lower requirement for patients to be in waiting bays before being allocated to an appropriate bay than laboratory-based tests, which may be of high importance in some hospitals. Tests that appeared more cost-effective also had better patient outcomes. Limitations There is considerable uncertainty in the values for key parameters within the model, although calibration was undertaken in an attempt to mitigate this. The example hospital simulated will also not match those of decision-makers deciding on the clinical effectiveness and cost-effectiveness of introducing SARS-CoV-2 point-of-care tests. Given these limitations, the results should be taken as indicative rather than definitive, particularly cost-effectiveness results when the relative cost per SARS-CoV-2 point-of-care test is uncertain. Conclusions Should a SARS-CoV-2 point-of-care test with a desirable target product profile become available, this appears promising, particularly when the reduction on the requirements for waiting bays before allocation to a SARS-CoV-2-infected bay, or a non-SARS-CoV-2-infected bay, is considered. The results produced should be informative to decision-makers who can identify the results most pertinent to their specific circumstances. Future work More accurate results could be obtained when there is more certainty on the diagnostic accuracy of, and the reduction in time to test result associated with, SARS-CoV-2 point-of-care tests, and on the impact of these tests on occupancy of waiting bays and isolation bays. These parameters are currently uncertain. Funding This report was commissioned by the National Institute for Health Research (NIHR) Evidence Synthesis programme as project number 132154. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 21. See the NIHR Journals Library website for further project information.

Regular estimates of paddock pasture mass can improve profitability on New Zealand dairy farms

2015 ◽  
Vol 77 ◽  
pp. 29-34 ◽  
Author(s):  
P.C. Beukes ◽  
S. Mccarthy ◽  
C.M. Wims ◽  
A.J. Romera
Keyword(s):  
Supply And Demand ◽  
Grazing Management ◽  
Average Error ◽  
Value Proposition ◽  
Perfect Knowledge ◽  
Operating Profit ◽  
A Value ◽  
Main Driver ◽  
Imperfect Knowledge ◽  
Farm Scale

Paddock selection is an important component of grazing management and is based on either some estimate of pasture mass (cover) or the interval since last grazing for each paddock. Obtaining estimates of cover to guide grazing management can be a time consuming task. A value proposition could assist farmers in deciding whether to invest resources in obtaining such information. A farm-scale simulation exercise was designed to estimate the effect of three levels of knowledge of individual paddock cover on profitability: 1) "perfect knowledge", where cover per paddock is known with perfect accuracy, 2) "imperfect knowledge", where cover per paddock is estimated with an average error of 15%, 3) "low knowledge", where cover is not known, and paddocks are selected based on longest time since last grazing. Grazing management based on imperfect knowledge increased farm operating profit by approximately $385/ha compared with low knowledge, while perfect knowledge added a further $140/ha. The main driver of these results is the level of accuracy in daily feed allocation, which increases with improving knowledge of pasture availability. This allows feed supply and demand to be better matched, resulting in less incidence of under- and over-feeding, higher milk production, and more optimal post-grazing residuals to maximise pasture regrowth. Keywords: modelling, paddock selection, pasture cover

Re-challenging antibiotic resistance with Daniel Berman

2020 ◽  
Author(s):  
Daniel Berman
Keyword(s):  
Bacterial Infections ◽  
Point Of Care ◽  
Healthcare Setting ◽  
Rapid Diagnostic Tests ◽  
Resistant Bacteria ◽  
Drug Resistant ◽  
Drug Resistant Bacteria ◽  
Global Threat ◽  
The Right ◽  
Point Of Care Tests

How can we prevent the rise of resistance to antibiotics? In this video, Daniel Berman,  Nesta Challenges, discusses the global threat of AMR and how prizes like the Longitude Prize can foster the development of rapid diagnostic tests for bacterial infections, helping to contribute towards reducing the global threat of drug resistant bacteria. Daniel outlines how accelerating the development of rapid point-of-care tests will ensure that bacterial infections are treated with the most appropriate antibiotic, at the right time and in the right healthcare setting.

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