Aims: To derive and validate a stakeholder-informed set of requirements for a clinical decision support system (CDSS) designed to support thrombosis and anticoagulant management.
Methods: A sequential mixed-methods design was conducted comprising a targeted literature review, semi-structured interviews, iterative questionnaire development, content validation, and quantitative analysis. Seven experts participated in the qualitative phase, and 35 cardiologists and clinical pharmacists completed the final 48-item questionnaire. Content validity was assessed using the content validity ratio (CVR) and item-level content validity index (I-CVI), internal consistency using Cronbach’s alpha, and group and age-related differences using nonparametric tests.
Findings: The literature review included 55 studies and indicated that existing CDSSs commonly address venous thromboembolism risk assessment, thromboprophylaxis, anticoagulant prescribing, or atrial fibrillation-related management. Interviews identified six requirement domains and 42 subthemes. All retained items had a CVR of 1.00, with an overall mean I-CVI of 0.996. Domain-level mean scores ranged from 4.42 to 4.67 on a five-point scale, and overall Cronbach’s alpha was 0.973. No significant differences were found between cardiologists and clinical pharmacists. Age was positively associated with the Clinical Information Requirements domain (ρ=0.372, p=0.033).
Conclusion: The validated framework encompasses clinical functionality, information requirements, workflow fit, perceived usefulness, usability, and trust. These findings provide stakeholder-informed requirements for specifying and evaluating thrombosis-focused CDSSs while supporting individualized anticoagulation decisions and preserving clinician oversight.