Vineland™-II Adaptive Behavior Scales for Autism Spectrum Disorder: An Electronic Version Is Conceptually Equivalent to the Standard Paper Version

Background: The Vineland Adaptive Behavior Scales, Second Edition (Vineland™-II) is a semi-structured interview-based clinical outcome assessment (COA) that is administered by a trained healthcare professional to the individual's caregiver/study partner. It assesses core domains of adaptive behavior and is recognized as an appropriate primary outcome measure for clinical trials in autism spectrum disorder (ASD). The Vineland-II is traditionally administered in paper format, but an electronic, tablet-based version has recently been developed for multicenter clinical trials.

Objectives: Regulatory guidance requires that whenever a COA is administered in a new mode, evidence is required to demonstrate that the COA’s measurement properties are equivalent or superior to the data produced from the original version. Thus, the objective of this study was to explore conceptual equivalence and usability of the electronic version of the Vineland-II compared with its original paper format.

Methods: Qualitative, face-to-face interviews were conducted with 10 healthcare professionals in the United States who had experience administering the paper version of the Vineland-II and treating patients with ASD. Interviews were split into 4 sections: training the healthcare professional on the use of the electronic Vineland-II; a mock-administration exercise; and 2 debriefing sessions, 1 for each mode of the Vineland-II. All interviews were digitally recorded and transcribed verbatim. Qualitative analysis was conducted on all transcripts by sorting quotes into concepts using thematic analysis methods using a qualitative data analysis and research software (ATLAS.ti).

Results: All 10 participants were able to successfully use the electronic version of the Vineland-II on a tablet and experienced no significant issues in completion. There were no apparent differences between levels of understanding of the instructions and items for the paper and electronic versions. No participants reported differences in how the items on the paper and electronic versions of the Vineland-II were displayed or suggested ways in which the items could be displayed better on the electronic version. No notable differences were identified between calculating and interpreting scores on the electronic and paper versions of the Vineland-II, and both modalities were considered equally acceptable and easy to use. All participants reported that they would complete both versions in the same manner, and that they would be comfortable completing the electronic version in a clinical trial setting.

Conclusions: This qualitative research with healthcare professionals provides strong evidence that the newly developed electronic version of the Vineland-II is conceptually equivalent to the original paper version. The evidence from this study supports the use of an electronic version of Vineland-II in multicenter clinical trials for ASD.