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P183 Driving Point of Care Technology Development: An Integrated Approach to Consensus Building Using Discrete Choice Experiments (DCE) and Facilitated Meetings

Tuesday, March 13, 2012
Hyatt Exhibit Hall
Joany Jackman, PhD1, Mary Jett-Goheen, BS2, Terry Hogan, BA, MPH3, Yu-Hsiang Hsieh, PhD4, Anne Rompalo, MD, ScM5 and Charlotte Gaydos, DrPH2, 1Research and Exploratory Development Department (REDD), Johns Hopkins University Applied Physics Laboratory, Laurel, MD, 2School of Medicine, Division of Infectious Diseases, STD Laboratory, Johns Hopkins University, Baltimore, MD, 3Bayview Medical Campus, Johns Hopkins Univerisity, Baltimore, MD, 4Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, 5School of Medicine, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD

Background: The need for point of care test (POCT) for diagnosis of Chlamydia trachomatis (Ct) is highly significant.  These infections are particularly hazardous to women since many are asymptomatic.  Despite the recognition that POCT for Ct is an urgent public health need and that technology advances in diagnostics have made rapid POCT realistic, no reliable POCT for Ct exists. 

Objectives: To describe a methodology, which can be used to address the barriers between the need for a Ct POCT and its realization. 

Methods: We employed a process known as WALEX (Warfare Analysis Laboratory Exercise), in combination with Design of Experiment (DOE) methodology using discrete choice experiments (DCE), to define the attributes of the most realistic (as opposed to the ideal) POCT.  The WALEX is an interactive oral and simultaneous electronic discussion between experts (end user, developer and regulatory participants) in different fields linked by a common interest in development of Ct POCT.    The use of DOE methods in creation of DCE provides defined metrics by which trade-offs are measured.

Results: Our study highlighted key features (assay time, preparation time, assay cost, instrument cost, sample source) of an ideal Ct POCT, ranked those most critical to test acceptance and those open to negotiation.  End users were more flexible on assay time (increased to 240 minutes) and instrument costs (increased to $10,000), if the requirement for higher assay throughput (4 samples), lowest test cost (<$10), and source collection (vaginal swabs) were preserved as necessary assay characteristics. 

Conclusions: WALEX combined with DCE identified differences between perceived and actual requirements for an acceptable Ct POCT, addressed the most realistic commercial solutions to bridge those gaps, and provided metrics regarding tradeoffs, which end users were willing to make.

Implications for Programs, Policy, and Research: Multidisciplinary approaches provide a better understanding of the real versus perceived needs for Ct POCT.

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