Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter November 9, 2018

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 , Melody Ni ORCID logo , Shivani Misra , Stella Mavroveli , James Barlow and George B. Hanna EMAIL logo



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.


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.


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.


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.

Corresponding author: Professor George B. Hanna, PhD, FRCS, Department of Surgery and Cancer, Imperial College London, Academic Surgical Unit, 10th Floor, QEQM Building, St Mary’s Hospital, South Wharf Road, London, W2 1NY, UK, Phone: +44 203 312 2124, Fax: +44 203 312 6309

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. 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.

  3. 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.

  4. Employment or leadership: None declared.

  5. Honorarium: None declared.

  6. 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.


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.i14.4111Search in Google Scholar PubMed PubMed Central

2. Price CP. Point of care testing. Br Med J 2001;322:1285–8.10.1016/B978-1-4160-6164-9.00020-2Search in Google Scholar

3. Global Point-of-Care Diagnostics Market Outlook. 2018. Accessed: 24 Apr 2015.Search in Google Scholar

4. Lijmer JG, Leeflang M, Bossuyt PM. Proposals for a phased evaluation of medical tests. Med Decis Making 2009;29:E13–21.10.1177/0272989X09336144Search 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;140:189–202.10.7326/0003-4819-140-3-200402030-00010Search in Google Scholar PubMed

6. NIHR Medtech and In Vitro Diagnostics Co-operatives (MICs). Accessed: 11 Sep 2018.Search in Google Scholar

7. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group: Test Evaluation. Accessed: 11 Sep 2018.Search in Google Scholar

8. Bossuyt PM. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem 2003;49:1–6.10.1309/8EXCCM6YR1THUBAFSearch 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.Search 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.f1049Search in Google Scholar PubMed

11. International Organization for Standardization. IEC 62366-1:2015 Medical devices – application of usability engineering to medical devices. Accessed: 11 Sep 2018.Search in Google Scholar

12. National Institute for Health and Clinical Excellence. Diagnostics Assessment Programme manual. 2011.Search 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-2015-007840Search 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/mzm042Search in Google Scholar PubMed

15. International Organization for Standardization. ISO 9241-11. Ergonomics of human-system interaction. Accessed: 11 Sept 2018.Search 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.2010.04.004Search in Google Scholar

Received: 2018-10-07
Accepted: 2018-10-10
Published Online: 2018-11-09
Published in Print: 2019-05-27

©2019 Walter de Gruyter GmbH, Berlin/Boston

Downloaded on 4.3.2024 from
Scroll to top button