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Authors
Klopotowska, Joanna E. http://orcid.org/0000-0002-9707-5740
Kuks, Paul F. M.
Wierenga, Peter C.
Stuijt, Clementine C. M.
Arisz, Lambertus
Dijkgraaf, Marcel G. W.
de Keizer, Nicolette
Smorenburg, Susanne M.
de Rooij, Sophia E.
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Hoekstra, Joost L. B.
Jansen, Minke E. P.
Meijer, Wim G.
van der Kleij, Bea M.
Lagaay, Anne M.
van der Hoeven, Ruud T. M.
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Article History
Received: 22 December 2021
Accepted: 27 April 2022
First Online: 17 June 2022
Declarations
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: This study was granted an exemption from requiring ethics approval and received a non-WMO waiver (February 14 2007 #07.17.0176) from the Medical Ethics Committee of the Amsterdam University Medical Center, University of Amsterdam, The Netherlands, since this study is outside the scope of the Dutch Medical Research Human Subjects Act (WMO). Furthermore, the committee agreed with data abstraction from patient charts without informed consent (February 14 2007 #21.240 # 07.17.0176) in light of the Medical Treatment Contract Act (in Dutch: Wet op de geneeskundige behandelovereenkomst) and the Code Good Conduct (in Dutch: Code Goed Gedrag). Within this legislative framework, reuse of patient data for research without informed consent was possible if the data abstracted were pseudonymised, and in situations where it cannot be reasonably required to ask consent due to a large sample size, a risk of response bias, or cohort selection. In this study, the risk of response bias was ascertained as high because a study on ADEs might lead to unwanted psychological discomfort and fear in patients. Moreover, the intervention was targeted at prescribers and not patients. All methods were carried out in accordance with relevant guidelines and regulations.
: Not applicable.
: The authors declare that they have no competing interests.
