Protocol for the development and validation of a trigger tool for antiretroviral ADE detection among adult HIV/AIDS patients: A short communication
1 Drug Information Unit, Department of Pharmacy, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria
2 Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria
3 Microbiology Program, Department of Biological Sciences, College of Science, Technology, Engineering and Mathematics, Alabama State University, Montgomery, AL 36104, USA.
4 Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria.
Short Communication
GSC Biological and Pharmaceutical Sciences, 2024, 28(02), 052–058.
Article DOI: 10.30574/gscbps.2024.28.2.0280
Publication history:
Received on 11 June 2024; revised on 31 July 2024; accepted on 02 August 2024
Abstract:
Antiretroviral therapy (ART) is a lifelong combination therapy which has been very promising in managing HIV/AIDs but reported to have several adverse events on the recipients, affecting the desired antiretroviral therapeutic goals. Adverse drug event detection and prevention therefore become very important safety culture maintenance tools among patients living with HIV/AIDS. The designed protocol provided step by step approaches to develop and validate a trigger tool for detection of adverse drug events (ADE) among adult HIV/AIDS patients. The approaches involved include a baseline (Pre-trigger tool development) retrospective clinical record review to establish a baseline ADE detection capacity of a conventional non-trigger tool method; the Delphi panel process to develop the trigger tool in question; Face and content validity approach for validation of the developed trigger tool; Pilot test of the trigger tool using small clinical record sample; determining the effectiveness of the developed trigger tool through the retrospective clinical record review of same samples reviewed at the baseline. Finally, the protocol described the process of determining the feasibility of the developed trigger tool through the survey of the clinical record review team members.
Keywords:
Protocol; Trigger tool; Development; Validation; Adverse drug event; HIV Patients
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