Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests

2019 ◽  
Vol 57 (6) ◽  
pp. 845-855 ◽  
Author(s):  
Jeremy R. Huddy ◽  
Melody Ni ◽  
Shivani Misra ◽  
Stella Mavroveli ◽  
James Barlow ◽  
...  
Keyword(s):  
Lead Time ◽  
Point Of Care ◽  
Structured Interview ◽  
Interview Study ◽  
Decision Makers ◽  
Face Validity ◽  
Stakeholder Workshop ◽  
Point Of Care Tests ◽  
Evidence Generation ◽  
Expert Workshop

Abstract Background This study aimed to develop the Point-of-Care Key Evidence Tool (POCKET); a multi-dimensional checklist to guide the evaluation of point-of-care tests (POCTs) incorporating validity, utility, usability, cost-effectiveness and patient experience. The motivation for this was to improve the efficiency of evidence generation in POCTs and reduce the lead-time for the adoption of novel POCTs. Methods A mixed qualitative and quantitative approach was applied. Following a literature search, a three round Delphi process was undertaken incorporating a semi-structured interview study and two questionnaire rounds. Participants included clinicians, laboratory personnel, commissioners, regulators (including members of National Institute for Health and Care Excellence [NICE] committees), patients, industry representatives and methodologists. Qualitative data were analysed based on grounded theory. The final tool was revised at an expert stakeholder workshop. Results Forty-three participants were interviewed within the semi-structured interview study, 32 participated in the questionnaire rounds and nine stakeholders attended the expert workshop. The final version of the POCKET checklist contains 65 different evidence requirements grouped into seven themes. Face validity, content validity and usability has been demonstrated. There exists a shortfall in the evidence that industry and research methodologists believe should be generated regarding POCTs and what is actually required by policy and decision makers to promote implementation into current healthcare pathways. Conclusions This study has led to the development of POCKET, a checklist for evidence generation and synthesis in POCTs. This aims to guide industry and researchers to the evidence that is required by decision makers to facilitate POCT adoption so that the benefits they can bring to patients can be effectively realised.

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.

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.

scholarly journals Comparison of Four Commercially Available Point-of-Care Tests to Detect Antibodies against Canine Parvovirus in Dogs

Viruses ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 18
Author(s):  
Michèle Bergmann ◽  
Mike Holzheu ◽  
Yury Zablotski ◽  
Stephanie Speck ◽  
Uwe Truyen ◽  
...  
Keyword(s):  
Test Performance ◽  
Point Of Care ◽  
Reference Method ◽  
Canine Parvovirus ◽  
P Value ◽  
Important Indicator ◽  
Specificity And Sensitivity ◽  
Specific Pathogen ◽  
The One ◽  
Point Of Care Tests

Measuring antibodies to evaluate dogs´ immunity against canine parvovirus (CPV) is useful to avoid unnecessary re-vaccinations. The study aimed to evaluate the quality and practicability of four point-of-care (POC) tests for detection of anti-CPV antibodies. The sera of 198 client-owned and 43 specific pathogen-free (SPF) dogs were included; virus neutralization was the reference method. Specificity, sensitivity, positive and negative predictive value (PPV and NPV), and overall accuracy (OA) were calculated. Specificity was considered to be the most important indicator for POC test performance. Differences between specificity and sensitivity of POC tests in the sera of all dogs were determined by McNemar, agreement by Cohen´s kappa. Prevalence of anti-CPV antibodies in all dogs was 80% (192/241); in the subgroup of client-owned dogs, it was 97% (192/198); and in the subgroup of SPF dogs, it was 0% (0/43). FASTest® and CanTiCheck® were easiest to perform. Specificity was highest in the CanTiCheck® (overall dogs, 98%; client-owned dogs, 83%; SPF dogs, 100%) and the TiterCHEK® (overall dogs, 96%; client-owned dogs, 67%; SPF dogs, 100%); no significant differences in specificity were observed between the ImmunoComb®, the TiterCHEK®, and the CanTiCheck®. Sensitivity was highest in the FASTest® (overall dogs, 95%; client-owned dogs, 95%) and the CanTiCheck® (overall dogs, 80%; client-owned dogs, 80%); sensitivity of the FASTest® was significantly higher compared to the one of the other three tests (McNemars p-value in each comparison: <0.001). CanTiCheck® would be the POC test of choice when considering specificity and practicability. However, differences in the number of false positive results between CanTiCheck®, TiterCHEK®, and ImmunoComb® were minimal.

The Experience of Indonesian Men Living with Type-2 Diabetes Mellitus and Erectile Dysfunction: A Semi-structured Interview Study

2021 ◽  
Vol 39 (2) ◽  
pp. 245-260
Author(s):  
Setho Hadisuyatmana ◽  
Ferry Efendi ◽  
Eka Mishbahatul Marah Has ◽  
Sylvia Dwi Wahyuni ◽  
Michael Bauer ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Erectile Dysfunction ◽  
Structured Interview ◽  
Interview Study

scholarly journals Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV

2020 ◽  
Vol 5 (11) ◽  
pp. e003457
Author(s):  
Nora Engel ◽  
Petra F G Wolffs
Keyword(s):  
Public Health ◽  
Business Models ◽  
Point Of Care ◽  
Decision Makers ◽  
Research Needs ◽  
Ethnographic Fieldwork ◽  
Evaluation Procedures ◽  
Semistructured Interviews ◽  
Intended Use ◽  
Global Stakeholders

Diagnostics, including those that work at point-of-care, are an essential part of successful public health responses to infectious diseases and pandemics. Yet, they are not always used or fit intended use settings. This paper reports on key insights from a qualitative study on how those engaged with developing and implementing new point-of-care (POC) diagnostics for tuberculosis (TB) and HIV ensure these technologies work at POC. Ethnographic fieldwork between 2015 and 2017 consisting of 53 semistructured interviews with global stakeholders and visits to workshops, companies, and conferences was combined with 15 semistructured interviews with stakeholders in India including providers, decision-makers, scientists and developers and visits to companies, clinics and laboratories. Our results show how developers and implementer of HIV and TB POC diagnostics aim to know and align their diagnostics to elements in more settings than just intended use, but also the setting of the developer, the global intermediaries, the bug/disease and the competitor. Actors and elements across these five settings define what a good diagnostic is, yet their needs might conflict or change and they are difficult to access. Aligning diagnostics to the POC requires continuous needs assessment throughout development and implementation phases as well as substantive, ongoing investment in relationships with users. The flexibility required for such continuous realigning and iteration clashes with established evaluation procedures and business models in global health and risks favouring certain products over others. The paper concludes with suggestions to strengthen this alignment work and applies this framework to research needs in the wake of COVID-19.

A preliminary investigation of the Partners in Health scale measurement properties in patients with end stage renal disease

2017 ◽  
Vol 23 (3) ◽  
pp. 288 ◽  
Author(s):  
Claire Baxter ◽  
Andrea Morello ◽  
David Smith ◽  
Lynda Norton ◽  
David Bentley
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Structured Interview ◽  
Face Validity ◽  
Measurement Properties ◽  
Self Management ◽  
Management Capacity ◽  
Stage Renal Disease ◽  
End Stage ◽  
Esrd Patients

End-stage renal disease (ESRD) is becoming more prevalent in Australia. As a result, strategies to improve quality of life when living with ESRD are becoming increasingly important. The Flinders Program has been developed to help support and increase the self-management capacity of people living with chronic disease. The Partners in Health (PIH) scale is a self-management capacity assessment tool, which is an integral element of the Flinders Program. The primary aim of this study was to investigate the preliminary measurement properties of the PIH scale within the ESRD population. Forty participants took part in the study, which involved survey assessments at baseline and follow up and a semi-structured interview. Results indicated that the PIH scale had good internal reliability (α=0.85), moderate test-retest reliability (r=0.33) and face validity in ESRD patients. Areas for improving the instrument or data collection process were identified through qualitative interviews, and implications are discussed specific to ESRD patients.

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