title: 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.
abstract: BACKGROUND
  Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS).
  
  
  METHODS
  A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise.
  
  
  BACKGROUND
  The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations.
authors.affiliation: Department of Surgery and Cancer, Imperial College, London, UK.
authors.forename: Jeremy R
authors.initials: JR
authors.lastname: Huddy
authors.affiliation: Department of Surgery and Cancer, Imperial College, London, UK.
authors.forename: Melody
authors.initials: M
authors.lastname: Ni
authors.affiliation: Department of Surgery and Cancer, Imperial College, London, UK.
authors.forename: Stella
authors.initials: S
authors.lastname: Mavroveli
authors.affiliation: Imperial College Business School, South Kensington Campus, London, UK.
authors.forename: James
authors.initials: J
authors.lastname: Barlow
authors.affiliation: British In Vitro Diagnostics Association (BIVDA), London, UK.
authors.forename: Doris-Ann
authors.initials: DA
authors.lastname: Williams
authors.affiliation: Department of Surgery and Cancer, Imperial College, London, UK.
authors.forename: George B
authors.initials: GB
authors.lastname: Hanna
mesh_terms: D057189:Checklist / Q000379:methods*; D032921:Consensus; D003697:Delphi Technique; D019937:Diagnostic Techniques and Procedures; D019317:Evidence-Based Medicine; D006801:Humans; D066298:In Vitro Techniques; D033181:Information Dissemination; D019095:Point-of-Care Systems
keywords: QUALITATIVE RESEARCH