Muluneh, Benyam

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.

Introduction To date, there is no adherence estimator to identify risk of nonadherence prior to initiating oral oncolytics. Methods A workgroup was assembled through the National Community Oncology Dispensing Association and tasked with creating a tool to meet this need. Tool constructs were defined after a review of the literature identifying top barriers to adherence. A second literature search was conducted to identify questions targeting specific barriers from validated adherence questionnaires. Once a finalized draft was complete, the risk assessment tool was built into an electronic survey where a risk category can be automatically calculated for the patient. Results The six most impactful factors affecting compliance to oral oncolytics were identified as patient's confidence, health literacy, perception of treatment, quality of life, social support, and complexity of chemotherapy regimen. A six-item questionnaire was created with five patient-directed questions and one clinician-directed question. Examples and descriptions were provided for clinicians to consider when categorizing complexity of a regimen. The tool was designed for responses to each question to be indexed into categories through a 10-point system. Results will be stratified into low, moderate, or high risk for nonadherence. Conclusion The creation of a tool to predict nonadherence prior to starting therapy is an unmet need for patients initiating oral oncolytics. The aim of this tool is to meet those needs and better guide clinicians to provide patients with strategies to better manage nonadherence. Next steps include tool validation and piloting in clinical practice.