An Estimate of the proportion of symptoms reported in Self-administered questionnaires that are captured as adverse drug events in an observational database

J. Raboud; M. Lesosky; S. Sterling; E.J. Phillips; S. Walmsley; A. Bayoumi

doi:10.1310/hct0805-311

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An Estimate of the proportion of symptoms reported in Self-administered questionnaires that are captured as adverse drug events in an observational database

Journal article

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An Estimate of the proportion of symptoms reported in Self-administered questionnaires that are captured as adverse drug events in an observational database

J. Raboud, M. Lesosky, S. Sterling, E.J. Phillips, S. Walmsley and A. Bayoumi

HIV Clinical Trials, Vol.8(5), pp.311-319

09/2007

DOI: https://doi.org/10.1310/hct0805-311

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Abstract

Purpose: This study was conducted to determine how frequently self-reported symptoms are captured as adverse drug events (ADEs) during chart abstraction. Method: We studied Ontario Cohort Study (OCS) participants attending the Toronto Hospital Immunodeficiency Clinic and compared OCS data on ADEs collected semi-annually through chart review and a self-administered questionnaire, completed on up to three occasions, which asked about the frequency, severity, and chronicity of symptoms including diarrhea, nausea, fatigue, and changes in body shape. Among 64 participants who completed the questionnaires, the median age was 42 years, the median time since HIV diagnosis was 9 years, 84% were male, 58% were men who had sex with men, 70% had viral load levels below 50 copies/mL, and the median CD4 was 422 cells/mm3. All patients were taking antiretroviral therapy. Results: The median (interquartile range) number of symptoms per participant reported on the questionnaire at the first visit was 3 (1-5). The most common symptoms reported by patients were diarrhea (58%), headache (59%), difficulty sleeping (52%), dry skin (53%), and changes in body shape (52%). The median number of ADEs during the study period per participant in OCS was 1 (0-2). Of 345 symptoms identified on the questionnaire, 16% were reported as ADEs in the OCS. Conclusion: Although some symptoms were correctly not classified as ADEs as they were not related to antiretroviral medication, others may have been missed due to incomplete reporting to the physician, incomplete physician recording, or errors in chart extraction.

Details

Title: An Estimate of the proportion of symptoms reported in Self-administered questionnaires that are captured as adverse drug events in an observational database
Authors/Creators: J. Raboud (Author/Creator)
M. Lesosky (Author/Creator)
S. Sterling (Author/Creator)
E.J. Phillips (Author/Creator)
S. Walmsley (Author/Creator)
A. Bayoumi (Author/Creator)
Publication Details: HIV Clinical Trials, Vol.8(5), pp.311-319
Publisher: Thomas Land Publishers Inc.
Identifiers: 991005541672707891
Copyright: © 2007 Thomas Land Publishers, Inc.
Murdoch Affiliation: Institute for Immunology and Infectious Diseases
Language: English
Resource Type: Journal article

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.66 HIV; 1.66.1372 HIV Comorbidities
Web Of Science research areas: Infectious Diseases; Pharmacology & Pharmacy
ESI research areas: Clinical Medicine