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

Assar, Gh.; Ansari, R.; Namazi, S.; Mohammadi, K.; Mollazadeh, R.; Zehtab Hashemi, H.; Roshan, M.; Safaei, A.A.

doi:10.58209/hehp.14.2.449

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

Document Type : Original Article

Authors

Gh. Assar ¹

R. Ansari ¹

S. Namazi ¹

K. Mohammadi ¹

R. Mollazadeh ²

H. Zehtab Hashemi ³

M. Roshan ⁴

A.A. Safaei ⁵

¹ Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences (TUMS), Tehran, Iran

² “Department of Cardiology, Faculty of Medicine” and “Imam Khomeini Hospital Complex (IKHC)”, Tehran University of Medical Sciences (TUMS), Tehran, Iran

³ Artificial Intelligence in Medical Sciences Research Center, Smart University of Medical Sciences, Tehran, Iran

⁴ Hormozgan Science and Technology Park, Bandar Abbas, Iran

⁵ Department of Medical Informatics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

10.58209/hehp.14.2.449

Abstract

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 35 cardiologists and clinical pharmacists completed the final 48-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 55 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 42 subthemes. All retained items had a content validity ratio of 1.00, and the overall mean item-level content validity index was 0.996. Domain-level mean scores ranged from 4.42 to 4.67 on a five-point scale, and the 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 48-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.

Keywords

Thrombosis

Anticoagulants

Decision Support Systems, Clinical

Surveys and Questionnaires

Medical Informatics

Subjects