Validity of Evaluation Criteria Is Not Clear
As an author of patient consent forms and as a clinician I am disappointed by the non-transparent study report and its summary employing stereotyped scientific jargon (1). What is the old standard? The authors provide only a summarized evaluation. Was there not a single qualified information leaflet? The authors’ conclusion, that their quality assessment of the explored consent forms may be generalized, is presumptuous. The validity of the “relevant evaluation criteria” remains completely opaque.
In contrast to evidence-based health information, the main function of consent forms lies in providing information for enhancing the mandatory pre-procedure patient-doctor communication; supporting an individually adequate decision; strengthening the relationship between doctor and patient; and minimizing the risks and adverse effects of a recommended medical procedure. Pre-procedure communication therefore does not not merely aim at providing evidence-based information, but also at eliciting from the patient crucial information about individual risks and values, attitudes or previous medical experiences which may be relevant for their decision. Thus, pre-procedure communication encompasses an important relationship aspect, which may outweigh the delivered evidence-based information in the patient´s decision-making process. Cognitive processing of evidence-based information will be curbed by concurrent threatening affects. If the consent form intensifies a patient’s anxiety, his/her ability to use the delivered evidence-based Information for an adequate decision will be hampered. The same is true when the consent form is used in a manner that triggers feelings of anger or helplessness. A consent form therefore has to be conceptually different from a predominantly litigation-avoiding package leaflet. If a consent sheet induces negative emotions, then a patient´s decision against a medical procedure may not be based on a sound informed consent and on patient autonomy, but may be due to poor communication, even if all the quality criteria of evidence-based health information have been met.
Dr. med. Herbert W. Kappauf
Facharzt für Innere Medizin – Onkologie und Hämatologie –
Palliativmedizin, Facharzt für Psychosomatische Medizin und Psychotherapie, Starnberg
Conflict of interest statement
Dr Kappauf is the author of three oncological consent forms that were not investigated in the study. He receives licensing fees/royalties from Thieme for these forms.
|1.||Lühnen J, Mühlhauser I, Steckelberg A: The quality of informed consent forms—a systematic review and critical analysis. Dtsch Arztebl Int 2018; 115: 377–83 VOLLTEXT|