Development and Validation of UCD-11

Researchers developing health-related tools for patients and families employ a range of approaches to involve prospective users in design and development

To develop a validated measure of the human- or user-centeredness of design and development processes for patient-centered tools.

Cross-sectional data from a previous systematic review of the design and development processes of 348 tools

Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis.

We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. Cronbach’s alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver or surrogate users were involved in steps to understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool, or (5) involved in steps intended to evaluate the tool, (6) the process had three or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion, (9) consulted before a first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved.

The measure UCD-11 may be used to quantitatively document the user- and human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to the people who will use them, rather than requiring people to adapt to tools.