Simplification of Patient Adverse Events Reporting Form for Oncology Patients

Section: Research Paper
Issue
Vol. 22 No. 2 (2025): Volume 22 Issue 2
Published
Jun 1, 2025
Pages
55-64

Abstract

Background: Reporting adverse drug events (ADEs) is critical for oncology medications development, monitoring effectiveness, and assessing treatment toxicity. Underreporting poses a major issue in evaluating the medication's safety profile. Underreporting was mainly due to a lack of simple, specific, and validated reporting forms for cancer patients. The study aims to develop a newly (simplified) electronic patient reporting form and compare it with the one already-in-use. Method: This study is a mixed-methods approach to develop and evaluate a simplified adverse event reporting form for oncology patients in Iraq. A Delphi technique was utilized to gather expert consensus on the strengths and weaknesses of the already-in-use and newly developed ADE reporting forms. A convenient sample of patients with various types of cancer was recruited to evaluate their preferences and opinions regarding the newly developed electronic form. Thematic analysis was utilized for qualitative data examination. Results: The Delphi panel consensus revealed the already-in-use form regarding its suitability for patient reporting While acknowledged as concise and straightforward for healthcare professionals (HCPs), the group emphasized that its design and content render it inaccessible and impractical for direct patient use. A comparative analysis of the two forms revealed significant differences in their design, accessibility, and user experience. The newly developed electronic form offers several advantages over the already-in-use paper-based form. The newly developed electronic reporting form shows excellent content validity for both clarity and relevance according to the calculated indices. Conclusion: The newly developed electronic patient-reported form, can significantly facilitate ADEs reporting. The findings highlight the potential afforded by digital tools to improve not only clinical practice but also patient-centered outcomes in oncology settings.

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Authors

Shahad Abdul-Salam Al-Mukhtar

Department of Clinical Pharmacy, College of Pharmacy, University of Mosul, Mosul, Iraq

ORCID
Mohammed Ibrahim Aladul

Pharmacovigilance center, Iraqi Ministry of Health, Baghdad, Iraq

ORCID
Manal Younus
ORCID

Identifiers

https://doi.org/10.33899/iraqij.p.2025.156548.1127
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How to Cite

Abdul-Salam Al-Mukhtar, S., Ibrahim Aladul, M., & Younus, M. (2025). Simplification of Patient Adverse Events Reporting Form for Oncology Patients. Iraqi Journal of Pharmacy, 22(2), 55–64. https://doi.org/10.33899/iraqij.p.2025.156548.1127