Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
-
Jeremy R. Huddy
,
Shivani Misra
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.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Transparency statement: The lead author affirms that this article is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Research funding: This research was supported by the National Institute for Health Research (NIHR) Diagnostic Evidence Co-operative London at Imperial College Healthcare NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and St Mary’s Hospital, South Wharf Road, London, W2 1NY, UK.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: All authors have completed the Unified Competing Interest form and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years, no other relationships or activities that could appear to have influenced the submitted work. The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Huddy JR, Ni MZ, Markar SR, Hanna GB. Point-of-care testing in the diagnosis of gastrointestinal cancers: current technology and future directions. World J Gastroenterol 2015;21:4111–20.10.3748/wjg.v21.i14.4111Suche in Google Scholar PubMed PubMed Central
2. Price CP. Point of care testing. Br Med J 2001;322:1285–8.10.1016/B978-1-4160-6164-9.00020-2Suche in Google Scholar
3. Global Point-of-Care Diagnostics Market Outlook. 2018. http://www.researchandmarkets.com/reports/2848147/global-point-of-care-diagnostics-market-outlook. Accessed: 24 Apr 2015.Suche in Google Scholar
4. Lijmer JG, Leeflang M, Bossuyt PM. Proposals for a phased evaluation of medical tests. Med Decis Making 2009;29:E13–21.10.1177/0272989X09336144Suche in Google Scholar PubMed
5. Whiting P, Rutjes AW, Reitsma JB, Glas AS, Bossuyt PM, Kleijnen J. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann Intern Med 2004;140:189–202.10.7326/0003-4819-140-3-200402030-00010Suche in Google Scholar PubMed
6. NIHR Medtech and In Vitro Diagnostics Co-operatives (MICs). https://www.nihr.ac.uk/about-us/how-we-are-managed/our-structure/infrastructure/Documents/medtech-and-in-vitro-diagnostic-co-operatives.htm. Accessed: 11 Sep 2018.Suche in Google Scholar
7. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group: Test Evaluation. https://www.eflm.eu/site/page/a/1158. Accessed: 11 Sep 2018.Suche in Google Scholar
8. Bossuyt PM. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem 2003;49:1–6.10.1309/8EXCCM6YR1THUBAFSuche in Google Scholar
9. Monaghan PJ, Robinson S, Rajdl D, Bossuyt PM, Sandberg S, St John A, et al. Practical guide for identifying unmet clinical need for biomarkers. EJIFCC 2018;29:129–37.Suche in Google Scholar
10. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Br Med J 2013;346:f1049.10.1136/bmj.f1049Suche in Google Scholar PubMed
11. International Organization for Standardization. IEC 62366-1:2015 Medical devices – application of usability engineering to medical devices. https://www.iso.org/standard/63179.html. Accessed: 11 Sep 2018.Suche in Google Scholar
12. National Institute for Health and Clinical Excellence. Diagnostics Assessment Programme manual. 2011.Suche in Google Scholar
13. Huddy JR, Ni M, Mavroveli S, Barlow J, Williams D-A, Hanna GB. A research protocol for developing a Point-of-Care Key Evidence Tool ‘POCKET’: a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics. BMJ Open 2015;5.10.1136/bmjopen-2015-007840Suche in Google Scholar PubMed PubMed Central
14. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349–57.10.1093/intqhc/mzm042Suche in Google Scholar PubMed
15. International Organization for Standardization. ISO 9241-11. Ergonomics of human-system interaction. https://www.iso.org/obp/ui/#iso:std:iso:9241:-11:ed-2:v1:en. Accessed: 11 Sept 2018.Suche in Google Scholar
16. Finstad K. Interacting with computers the usability metric for user experience. Interact Comput 2010;22:323–7.10.1016/j.intcom.2010.04.004Suche in Google Scholar
©2019 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Obituary
- Professor Howard A. Morris
- Editorial
- The silk road to total quality in Laboratory Medicine
- Reviews
- Moving average quality control: principles, practical application and future perspectives
- Serum α-fetoprotein in pediatric oncology: not a children’s tale
- Mini Review
- Value-based healthcare: the role of laboratory medicine
- Opinion Paper
- Advantages and limitations of total laboratory automation: a personal overview
- General Clinical Chemistry and Laboratory Medicine
- Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
- A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China
- Quality assessment of interpretative commenting and competency comparison of comment providers in China
- Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program
- Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
- Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab
- Hematology and Coagulation
- Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
- Danger of false negative (exclusion) or false positive (diagnosis) for ‘congenital thrombophilia’ in the age of anticoagulants
- Point-of-care haemostasis monitoring during liver transplantation is cost effective
- Reference Values and Biological Variations
- Evaluation of reference intervals of haematological and biochemical markers in an Austrian adolescent study cohort
- Cancer Diagnostics
- A novel machine learning-derived decision tree including uPA/PAI-1 for breast cancer care
- Cardiovascular Diseases
- Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform
- Infectious Diseases
- Improvement in detecting sepsis using leukocyte cell population data (CPD)
- Letters to the Editor
- The biological variation of plasma proenkephalin: data from a stable heart failure cohort
- Hemoglobin variants found in relation to HbA1c testing: high occurrence of Hb Athens-Georgia in the Northern Jutland, Denmark
- Eltrombopag interferes with the measurement of plasma total bilirubin in pediatric patients in an automated colorimetric method
- A challenging case: highly variable TSH in a mother and her two children
- Suppressing all test results in grossly hemolyzed samples: is this approach appropriate in every case?
- Prozone effect observed for heavy chain α in the serum immunofixation electrophoresis of a patient with monoclonal IgA-λ gammopathy
- Significant allelic dropout phenomenon of Oncomine BRCA Research Assay on Ion Torrent S5
- Evaluation of immature platelet fraction in patients with myelodysplastic syndromes. Association with poor prognosis factors
- Influence of temperature of transport of whole blood on plasma Cu, I, Mn, Se and Zn and Mg concentrations in erythrocytes
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Artikel in diesem Heft
- Frontmatter
- Obituary
- Professor Howard A. Morris
- Editorial
- The silk road to total quality in Laboratory Medicine
- Reviews
- Moving average quality control: principles, practical application and future perspectives
- Serum α-fetoprotein in pediatric oncology: not a children’s tale
- Mini Review
- Value-based healthcare: the role of laboratory medicine
- Opinion Paper
- Advantages and limitations of total laboratory automation: a personal overview
- General Clinical Chemistry and Laboratory Medicine
- Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
- A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China
- Quality assessment of interpretative commenting and competency comparison of comment providers in China
- Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program
- Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
- Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab
- Hematology and Coagulation
- Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
- Danger of false negative (exclusion) or false positive (diagnosis) for ‘congenital thrombophilia’ in the age of anticoagulants
- Point-of-care haemostasis monitoring during liver transplantation is cost effective
- Reference Values and Biological Variations
- Evaluation of reference intervals of haematological and biochemical markers in an Austrian adolescent study cohort
- Cancer Diagnostics
- A novel machine learning-derived decision tree including uPA/PAI-1 for breast cancer care
- Cardiovascular Diseases
- Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform
- Infectious Diseases
- Improvement in detecting sepsis using leukocyte cell population data (CPD)
- Letters to the Editor
- The biological variation of plasma proenkephalin: data from a stable heart failure cohort
- Hemoglobin variants found in relation to HbA1c testing: high occurrence of Hb Athens-Georgia in the Northern Jutland, Denmark
- Eltrombopag interferes with the measurement of plasma total bilirubin in pediatric patients in an automated colorimetric method
- A challenging case: highly variable TSH in a mother and her two children
- Suppressing all test results in grossly hemolyzed samples: is this approach appropriate in every case?
- Prozone effect observed for heavy chain α in the serum immunofixation electrophoresis of a patient with monoclonal IgA-λ gammopathy
- Significant allelic dropout phenomenon of Oncomine BRCA Research Assay on Ion Torrent S5
- Evaluation of immature platelet fraction in patients with myelodysplastic syndromes. Association with poor prognosis factors
- Influence of temperature of transport of whole blood on plasma Cu, I, Mn, Se and Zn and Mg concentrations in erythrocytes
- Absorbent materials to collect urine can affect proteomics and metabolomic biomarker concentrations
