TORONTO, ON--(Marketwired - October 10, 2016) -
During the webinar, Dr. Wilhelm Muehlhausen, Head of Innovation at ICON, Kai Langel, Co-Founder and Director Patient Solutions at eClinicalHealth will provide insight on how organizations can develop a methodology and standards for migrating instruments for capturing clinical outcomes that would be applicable to any device. The live broadcast will take place on Wednesday, October 26, 2016 at 10am EDT (3pm BST/UK).
Current guidance from the FDA and ISPOR (2009) recommends that when a Patient Reported Outcome (PRO) instrument is migrated between different modalities (for example, from a paper PRO to an electronic (ePRO) format), additional evidence is required in order to demonstrate that the measurement properties of the ePRO application are comparable if not superior to the original PRO format.
In the case of a migration of a paper instrument to an electronic device, when non-substantive changes are made (i.e. changing 'circle' on paper to 'select' or 'click' on an electronic device; or minor changes in format such as one item per screen rather than multiple items on a page) this qualifies as a minor modification. According to good practice guidelines (Coons et al; 2009), this should be addressed through cognitive debriefing and usability testing interviews in the population of interest.
However, with the advent of web-based instruments and bring-your-own-device (BYOD), validation becomes more challenging: due to an increasingly diverse range of mobile phones and tablets on the market, with varying screen sizes, operating systems etc.
This is considered in relation to a specific project whereby guidelines were produced for migrating one such PRO instrument, the Anti-Clot Treatment Scale (ACTS) to electronic format. For this project, an exploratory usability study of the electronic version of the ACTS was carried out, using a full-sized tablet (iPad), an iPad mini, a laptop and a phone. Twenty English-speaking participants aged 60-77 completed the ACTS in the various formats and were observed and interviewed about how the instrument was best used on the devices; the importance of being able to see the recall period; the impact of horizontal scrolling; user-preference and patient burden of the single question per page versus the current layout of the ACTS; and the minimum usable device size.
The objectives of this webinar are to:
- Introduce the concept of BYOD in eCOA
- Describe regulatory expectations and current best practices in PRO migration to electronic devices
- Highlight the challenges that the current regulatory environment poses to BYOD
- Provide an in-depth case study of developing a process to migrate a specific instrument, the ACTS, to electronic format
- Present the process that was developed for migrating this instrument
To learn more about this event visit: Bring Your Own Device (BYOD) eCOA - Instrument Validation Methodology
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