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

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Title: Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
Authors: Huddy, JR
Ni, M
Misra, S
Mavroveli, S
Barlow, J
Hanna, GB
Item Type: Journal Article
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.
Issue Date: 1-Jun-2019
Date of Acceptance: 10-Oct-2018
URI: http://hdl.handle.net/10044/1/71967
DOI: https://doi.org/10.1515/cclm-2018-1089
ISSN: 1434-6621
Publisher: De Gruyter
Start Page: 845
End Page: 855
Journal / Book Title: Clinical Chemistry and Laboratory Medicine
Volume: 57
Issue: 6
Copyright Statement: © 2018 The Authors. Published by De Gruyter.
Keywords: Science & Technology
Life Sciences & Biomedicine
Medical Laboratory Technology
checklist
diagnostic equipment
diagnostic test approval
point-of-care testing
DIAGNOSTIC-ACCURACY
checklist
diagnostic equipment
diagnostic test approval
point-of-care testing
Science & Technology
Life Sciences & Biomedicine
Medical Laboratory Technology
checklist
diagnostic equipment
diagnostic test approval
point-of-care testing
DIAGNOSTIC-ACCURACY
1103 Clinical Sciences
1702 Cognitive Sciences
General Clinical Medicine
Publication Status: Published
Online Publication Date: 2018-11-09
Appears in Collections:Imperial College Business School
Department of Medicine (up to 2019)