Developing and Validating a Stakeholder-Informed Requirements Framework for a Thrombosis and Anticoagulation Clinical Decision Support System

Aims: This study aimed to derive and validate a stakeholder-informed set of requirements for a clinical decision support system designed to support thrombosis and anticoagulant management.Instrument & Methods: This sequential mixed-methods study identified, operationalized, and quantitatively evaluated stakeholder-informed requirements for a thrombosis and anticoagulation clinical decision support system through a targeted literature review, semi-structured interviews, iterative questionnaire development, content validation, and quantitative analysis. Seven experts participated in the qualitative phase, and ۳۵ cardiologists and clinical pharmacists completed the final ۴۸-item questionnaire. Content validity was assessed using the content validity ratio and item-level content validity index; internal consistency was assessed using Cronbach’s alpha; and group and age-related differences were assessed using nonparametric tests.Findings: The literature review included ۵۵ studies and indicated that existing clinical decision support systems commonly address venous thromboembolism risk assessment, thromboprophylaxis, anticoagulant prescribing, or atrial fibrillation-related management. Interviews identified six requirement domains and ۴۲ subthemes. All retained items had a content validity ratio of ۱.۰۰, and the overall mean item-level content validity index was ۰.۹۹۶. Domain-level mean scores ranged from ۴.۴۲ to ۴.۶۷ on a five-point scale, and the overall Cronbach’s alpha was ۰.۹۷۳. No significant differences were found between cardiologists and clinical pharmacists. Age was positively associated with the Clinical Information Requirements domain (ρ=۰.۳۷۲, p=۰.۰۳۳).Conclusion: The ۴۸-item, six-domain framework provides a stakeholder-informed, content-valid basis for specifying and evaluating thrombosis-focused clinical decision support systems that support individualized anticoagulation decisions while preserving clinician oversight.

کلیدواژه ها:

Thrombosis ، Anticoagulants ، Decision Support Systems ، Clinical ، Surveys and Questionnaires ، Medical Informatics