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Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review

Author

Listed:
  • Renly Lim

    (Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia)

  • Lisa Kalisch Ellett

    (Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia)

  • Elizabeth E. Roughead

    (Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia)

  • Phaik Yeong Cheah

    (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7FZ, UK
    Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand
    The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7FZ, UK)

  • Nashwa Masnoon

    (Laboratory of Ageing and Pharmacology, Kolling Institute, University of Sydney, St Leonards, NSW 2064, Australia
    Department of Pharmacy, Royal North Shore Hospital, St Leonards, NSW 2065, Australia)

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.

Suggested Citation

  • Renly Lim & Lisa Kalisch Ellett & Elizabeth E. Roughead & Phaik Yeong Cheah & Nashwa Masnoon, 2021. "Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review," IJERPH, MDPI, vol. 18(22), pages 1-17, November.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:22:p:11877-:d:677721
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    References listed on IDEAS

    as
    1. Adam Gater & Matthew Reaney & Amy Findley & Catherine Brun-Strang & Kate Burrows & My-Liên Nguyên-Pascal & Aude Roborel de Climens, 2020. "Development and First Use of the Patient’s Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit–Harm of Drugs Received During Clinical," Drug Safety, Springer, vol. 43(2), pages 119-134, February.
    2. Lee Cronbach, 1951. "Coefficient alpha and the internal structure of tests," Psychometrika, Springer;The Psychometric Society, vol. 16(3), pages 297-334, September.
    3. Tim W. A. Schoenmakers & Martina Teichert & Michel Wensing & Peter A. G. M. Smet, 2017. "Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study," Drug Safety, Springer, vol. 40(5), pages 419-430, May.
    4. Sophie Staniszewska & Kirstie Haywood & Jo Brett & Liz Tutton, 2012. "Patient and Public Involvement in Patient-Reported Outcome Measures," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 5(2), pages 79-87, June.
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