A STUDY OF THE SUCCESSFUL ADAPTATION OF THE QUALITY OF LIFE QUESTIONNAIRE - BRONCHIECTASIS FROM PAPER TO ELECTRONIC FORMAT
Author(s)
Simpson H1, Ong SH2, Quittner A3, McEvoy K4, Dhariwal M5
1Corporate Translations, Inc., East Hartford, CT, USA, 2Novartis Pharma AG, Basel, Switzerland, 3University of Miami, Miami, FL, USA, 4CRF Health, London, UK, 5Novartis Ireland Ltd, Dublin, Ireland
OBJECTIVES: ISPOR ePRO Task-Force recommends that when an ePRO measure is adapted from a paper, evidence should be generated demonstrating that the measurement properties of the ePRO are comparable to the original paper PRO format (Coons et al, 2009). The objective of this testing was to migrate the paper-based source US English Quality of Life-Bronchiectasis (QOL-B) questionnaire v3.1 (Quittner et al. 2010) to an electronic platform. This study evaluated whether the electronic version was user-friendly and whether patient understanding was impacted. Cognitive debriefing and usability testing were performed using the ISPOR recommendations. METHODS: Initially, ePRO screens using the proprietary software (CRF Health Inc.) were created and checked to ensure the wording had been migrated successfully. The tablet was then tested to ensure user-friendliness and functionality. Following this, the eQOL-B was tested with 10 bronchiectasis patients in the USA. Patients were asked questions about the usability of the device and whether they had any recommendations based on their experience. Five (5) of these patients participated in additional full cognitive debriefing interviews, ensuring that the migration process did not influence their understanding of the questions or rating scales. RESULTS: Minor changes to the format of questions and instructions were made in the electronic version. Respondent understanding and device functionality were tested during cognitive debriefing and usability testing, with no issues were identified. All patients found the device straightforward and easy to use, even when it was their first time completing a PRO on an electronic device. CONCLUSIONS: The review of the draft eQOL-B ensured that the electronic version of the QOL-B was faithful to the source paper version. Intensive testing of the measure concluded that the electronic version was user-friendly, intuitive and maintained the integrity of the instrument. Thus, the electronic version of the QOL-B is considered ready for use in clinical trials or clinical practice.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PRM172
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Respiratory-Related Disorders