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Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective

Author

Listed:
  • Jette A. Lint

    (Netherlands Pharmacovigilance Centre Lareb
    Radboudumc)

  • Marlieke Sonnenberg

    (Netherlands Pharmacovigilance Centre Lareb)

  • Harald E. Vonkeman

    (Medisch Spectrum Twente
    University of Twente)

  • Bart J. F. Bemt

    (Radboudumc
    Sint Maartenskliniek)

  • Eugene P. Puijenbroek

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen)

  • Naomi T. Jessurun

    (Netherlands Pharmacovigilance Centre Lareb)

Abstract

Introduction There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective have not been identified before. Objective We aimed to develop a framework based on common themes in the course of ADRs identified from patient descriptions in patient-reported ADRs. Methods In this qualitative study, patient descriptions of the course of patient-reported ADRs were analysed by a thematic analysis with an inductive approach using three different existing datasets containing patient-reported ADRs. Two datasets included patient-reported ADRs from cohort event monitoring of biologics and direct oral anticoagulants and one dataset included spontaneous reports from patients concerning medication for lower urinary tract symptoms. A conceptual framework was developed from the identified main themes and subthemes. Results Patient-reported data concerning 3888 ADRs were analysed. Six main themes with multiple subthemes were identified from patient descriptions of the course of ADRs. Four themes were descriptive: frequency of an ADR episode, duration of an ADR episode, moment or period of ADR occurrence, and development in the intensity of the ADR. Two themes concerned factors influencing the course of ADRs: triggering factors and improving factors. Conclusions The presented framework illustrates that patients describe extensive details on the course and timeframe of ADRs. The identified themes provide a basis for improving the systematic data collection of more extensive details about ADRs from patients as a first step towards the provision of more comprehensive ADR information to patients.

Suggested Citation

  • Jette A. Lint & Marlieke Sonnenberg & Harald E. Vonkeman & Bart J. F. Bemt & Eugene P. Puijenbroek & Naomi T. Jessurun, 2023. "Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective," Drug Safety, Springer, vol. 46(10), pages 1039-1047, October.
    • Handle: RePEc:spr:drugsa:v:46:y:2023:i:10:d:10.1007_s40264-023-01343-y
    DOI: 10.1007/s40264-023-01343-y
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    1. Jette A. Lint & Naomi T. Jessurun & Renske C. F. Hebing & Frank Hoentjen & Sander W. Tas & Harald E. Vonkeman & Martijn B. A. Doorn & Annemieke Sobels & Phyllis I. Spuls & Eugene P. Puijenbroek & Mich, 2020. "Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases," Drug Safety, Springer, vol. 43(9), pages 917-925, September.
    2. Linda Härmark & June Raine & Hubert Leufkens & I. Ralph Edwards & Ugo Moretti & Viola Macolic Sarinic & Agnes Kant, 2016. "Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?," Drug Safety, Springer, vol. 39(10), pages 883-890, October.
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