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31. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

21.11. - 22.11.2024, Bonn

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Development of a standardized questionnaire for patient-reported outcomes of adverse drug reactions

Entwicklung eines standardisierten Fragebogens zu unerwünschten Arzneimittelwirkungen aus Patientensicht

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  • corresponding author presenting/speaker Judith Berres - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany
  • Hannah Fölsch - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany
  • Jule Neiß - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany
  • Dominik Krzoska - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany
  • Katja S. Just - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany
  • Julia C. Stingl - Institut für Klinische Pharmakologie, Uniklinik RWTH Aachen, Aachen, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 31. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn, 21.-22.11.2024. Düsseldorf: German Medical Science GMS Publishing House; 2024. Doc24gaa04

doi: 10.3205/24gaa04, urn:nbn:de:0183-24gaa040

Published: November 13, 2024

© 2024 Berres et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Background: Especially patients under polymedication and older adults suffer of a higher risk of adverse drug reactions (ADRs). A routine acquisition of patient-reported ADRs is hence beneficial and recommended by the current German S3 guideline for multimedication [1]. Yet, a standardised procedure to rate patient-reported outcomes in clinical practice is missing.

Materials and Methods: A detailed questionnaire on patient-reported ADR symptoms was developed using the online reporting form of PEI [2], a DELPHI process of the European SafePolyMed project and a former used questionnaire of the University Hospital Aachen.

Results: The developed standardized questionnaire contained 119 ADR symptoms structured in 15 thematic classes. These were supplemented by a patient education, a detailed medication documentation, the EQ-5D-5L questionnaire, and a causality assessment according to WHO-UMC rated by a clinician. By subdivision and partial query, the number of questions can be reduced individually for each patient. Additional gender-specific questions include two questions for men and five for women.

Conclusion: Our new questionnaire has the promising potential to gain deeper understanding of how patients rate their medication regarding ADRs. It may offer a suitable basis for improving the therapy. Further validation regarding scope of questions, sensitivity and specificity are currently under investigation in older, polymedicated patients.

Outline

References

1.
DEGAM Leitliniengruppe Hessen. S3-Leitlinie Multimedikation. AWMF-Registernummer: 053-043. Langfassung. 2. Aufl. 2021. Available from: https://www.degam.de/leitlinie-s3-053-043 External link
2.
Paul-Ehrlich-Institut. Online-Meldung von Nebenwirkungen. [last accessed 2024 Sep 16 2024]. Available from: https://nebenwirkungen.bund.de/SiteGlobals/Forms/nebenwirkungen/01-person/person-node.html External link