Abstract
Background: This systematic review aims to summarise available patient-reported questionnaires to detect adverse drug reactions (ADRs) that can be utilised by healthcare professionals in clinical practice and to summarise the psychometric properties (validity, reliability, and responsiveness) of the questionnaires. Methods: A systematic literature search was conducted using Medline, Pubmed, Embase, and Emcare databases to screen for articles published between January 2000 and July 2020. Data items regarding validity, reliability, and responsiveness were extracted independently by two authors. The methodological quality was assessed using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) checklist. Results: A total of 1563 unique article titles were identified after removing duplicates. Following shortlisting of relevant articles, 19 patient-reported ADR questionnaires were identified. Questionnaires most commonly focused on mental health medications (42.1%, n = 8), followed by general questionnaires applicable to any medication (21.1%, n = 4). Many questionnaires did not report assessing the validity and reliability of the measurement tool. For example, only 11 questionnaires (58%) mentioned assessing content validity, in addition to criterion or construct testing. Conclusion: This systematic review summarised the available patient-reported questionnaires that can be used in research and clinical practice to identify ADRs. Results of this systematic review highlight the need for more robust validity and reliability testing when developing patient-reported ADR questionnaires.
Highlights
We found that different types of patient self-reported questionnaires to identify medication sideeffects have been developed, with questionnaires most commonly focusing on identifying side-effects due to mental health medications
We found that the level of detail was variable between the questionnaires; general questionnaires asked whether patients had experienced sideeffects, whereas condition- or medication-specific questionnaires provided a thorough list of potential adverse drug reactions (ADRs)
This systematic review summarised the available patient-reported questionnaires that can be used in research and clinical practice to identify ADRs
Summary
Adverse drug reactions (ADRs) are unintended and unexpected effects caused by administration of a medication [3]. This systematic review aims to summarise available patient-reported questionnaires to detect adverse drug reactions (ADRs) that can be utilised by healthcare professionals in clinical practice and to summarise the psychometric properties (validity, reliability, and responsiveness) of the questionnaires. Following shortlisting of relevant articles, 19 patient-reported ADR questionnaires were identified. Many questionnaires did not report assessing the validity and reliability of the measurement tool. Conclusion: This systematic review summarised the available patient-reported questionnaires that can be used in research and clinical practice to identify ADRs. Results of this systematic review highlight the need for more robust validity and reliability testing when developing patient-reported ADR questionnaires
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