Content validation of a pre-treatment oral oncolytic non-adherence estimator (ORACLE)

Abstract

Background

Oral anti-cancer treatment is commonly used, and non-adherence can negatively affect outcomes. The Oral Oncolytic Non-Adherence Estimator (ORACLE) was designed to prospectively categorize patients into risk levels by considering constructs such as self-efficacy, health literacy, perception of treatment, quality of life, social support, and regimen complexity. Validating this estimator is essential.

Methods

A content validation survey evaluated representativeness, clarity, and factor structure of each construct in ORACLE. A multidisciplinary panel of 8 content experts and 4 lay experts completed the survey. Results were analyzed to evaluate inter-rater agreement, content validity index (CVI), and factorial validity index (FVI). Post-survey workgroup discussions reviewed results and considered tool adjustments.

Results

All 12 invited experts completed the survey. The average CVI for content experts was 0.88 for representativeness and 0.98 for clarity. The average CVI for lay experts was 0.95 for clarity. The average FVI was 0.88, with self-efficacy and negative perception constructs yielding the lowest scores (0.63 and 0.75, respectively). ORACLE revisions addressed survey results and expert feedback on health literacy, social support, and regimen complexity.

Conclusions

Strong CVI for content and lay experts (94% and 95%) and strong FVI for content experts (98%) verify that the tool is understandable and addresses non-adherence issues, establishing validity of construct clarity and representativeness.

Content validity of the first pre-treatment oral oncolytic non-adherence risk estimator was established, providing a reliable tool to identify patients at higher risk of non-adherence.