Bring Your Own Device (BYOD) eCOA – Instrument Validation Methodology

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), empirical 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 webinar discusses how we can develop a methodology and minimum standards for migrating instruments that would be applicable to any device.

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 interviewed about how the instrument was best displayed 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.

Speakers

Dr. Wilhelm Muehlhausen, Head of Innovation, ICON

Wilhelm has been involved in clinical research for more than 20 years and has held positions in Data Management, Clinical Research Operations and Project Management, Business Development and Product Management and Innovation. During his career he has specialised in developing new products and services for CROs and technology providers. He has represented the ePRO vendors as the inaugural Vice Chair of the ePRO consortium and overseen the development of important guidelines regarding the development and migration of questionnaires from paper to electronic formats.

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Kai Langel, Director Patient Solutions, eClinicalHealth

Since 2000, Kai has been a pioneer in patient-facing systems for clinical trials. Through his various technical, operational and scientific roles, he has gained an in-depth understanding of the patient journey in clinical trials from recruitment and engagement through data capture. As one of the founders of eClinicalHealth, Kai supports the global Clinpal Team and advises Clinpal customers on how to best operationalize new and innovative methods to ensure easier and more efficient technology-enabled processes for both sites and patients.

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Helen Marson-Smith, Outcomes Researcher, Clinical Outcomes Assessment, ICON (Webinar Content Contributor)

Helen joined ICON in 2013 as a researcher and project manager within the eCOA group. She is a sociologist by training, with a particular focus on qualitative research methodologies and fifteen years’ experience of working within research, including research posts at the University of Oxford and Oxford Brookes University. She holds a Bachelor’s Degree, Masters with Distinction, and PhD in Sociology from the University of Warwick. Since joining ICON, Helen’s work has focussed on the development and validation of PRO instruments, particularly in relation to the migration of instruments from paper to electronic devices, in various indications including asthma, chronic migraine, bowel disease and multiple myeloma, and several vaccine report card projects.

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