A multi-dimensional evidence toolkit for the evaluation of point-of-care diagnostic tests

Abstract

Point-of-care tests (POCT) allow for near patient or bedside tests that provide instant or rapid results that facilitate real time clinical decision making within patient pathways. Advances in technology has lead to more POCT becoming available and therefore an efficient evaluation process is required to identify the tests that bring demonstrable benefits to patients and society. This thesis provides a novel evidence-based toolkit for the multi-dimensional assessment of POCT that aims to improve the efficiency of the evidence generation process and increase the uptake of POCT devices into clinical practice where their impact can be realised. This is achieved through the development of an overarching framework, the point-of-care key evidence tool (POCKET). This generalisable checklist, developed through a mixed method approach, incorporating relevant POCT stakeholders, facilitates the robust reporting of POCT evaluation by outlining the evidence that is required for adoption by policy and decision makers. Public and patient engagement is a fundamental component of healthcare research and particularly important in the evaluation of POCT to ensure tests are acceptable to patients. To improve this process in the evaluation of POCT two innovative tools were piloted. Sequential simulation (SqS) of clinical pathways was used to demonstrate the downstream pathway implications of incorporating a POCT and the HT-36 questionnaire was created to measure the impact to life of home POCT for patients. This information will allow meaningful comparisons between different devices and inform device design. Finally, evidence alone is not enough to justify the adoption of POCT and barriers and facilitators exist. These factors are determined through the analysis of stakeholder interviews with the same methodology being applied to a case study to understand the barriers that apply to a specific device and develop mitigating strategies. The thesis concludes with an algorithm to guide the approach to the evaluation of POCT.Open Acces