The First Validated Innovation in Scale Design Since the Migration to Screens: Results of an Equivalence Study, Testing a New Graphical Version of the Widely Used Verbal Rating Scale

Author(s)

Muehlhausen W1, Doll HA2, Hellman B3, James B3, Nagrani G4, O'Neill B5, Ward T5
1SAFIRA Clinical Research Ltd, Cloughjordan, TA, Ireland, 2Clinical Outcomes Solutions, Folkestone, UK, 3uMotif, London, UK, 4SAFIRA Clinical Research Ltd, Cloughjordan, ON, Ireland, 5Dublin City University, Dublin, Ireland

OBJECTIVES: While the use of PROMs in clinical research continues to grow and user interface design evolves steadily, newly developed PROMs use mostly standard scale types such as Numeric Rating Scale(NRS), Verbal Response Scale(VRS), Visual Analog Scale(VAS) in a paper-based original design. This research validated a modern design for the VRS and tested it against the standard VRS-design of the EQ-5D-5L to encourage instrument developers to utilise modern design approaches supported by new technology.

METHODS: A randomised equivalence study with 55 participants in two groups (Group A=28, Group B=27) and a cross-over design using the standard EQ-5D-5L VRS vs. the new VRS design was conducted. A short training of the two VRS versions was provided to the participants. A period with an active distraction task between the applications was observed and the Intraclass Correlation Coefficient (ICC) for the EQ-5D-5L were calculated to show measurement equivalence between the two VRS versions. Participants of both groups also completed the identical EQ-5D-5L vertical scale.

RESULTS: Participants in both groups reported no difficulty with the new petal-like (motif) VRS widget and all participants successfully completed both versions of the VRS. The ICC of 0.875 and the lower bound 95%-confidence interval of 0.796 are strong indications that these two representations of the VRS are equivalent.

CONCLUSIONS: Existing and newly developed PROMs utilise only a limited number of well established scale types. These were developed for use on paper and then, almost unchanged, migrated to electronic platforms. This project shows that it is possible to develop modern graphical user interfaces of existing standard scale types (i.e. VRS) without changing psychometric properties of the PROM. The motif VRS can be used to replace the standard VRS design in existing and in the development of new PROMs.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)

Code

PCR49

Topic

Patient-Centered Research, Study Approaches

Topic Subcategory

Clinical Trials, Instrument Development, Validation, & Translation, Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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