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The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis.
Julia Lühnen1, Ingrid Mühlhauser, Anke Steckelberg
1Unit of Health Sciences and Education, MIN Faculty, University of Hamburg; Institute of Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale).
Deutsches Arzteblatt International
|June 23, 2018
Summary
Informed consent forms often lack crucial details about medical procedure risks and alternatives, hindering patient decision-making. New standards are essential to improve the quality and efficacy of these vital documents.
Area of Science:
- Medical Ethics
- Health Communication
- Patient Safety
Background:
- Patient consent requires physician discussion documented on standardized forms.
- Existing informed consent forms frequently lack information vital for informed decision-making.
Purpose of the Study:
- To systematically review the quality and efficacy of informed consent forms.
- To analyze the decisionally relevant content and intelligibility of German informed consent forms.
Main Methods:
- Systematic literature search up to February 2017 for content analyses of informed consent forms.
- Evaluation of 37 German informed consent forms for content and presentation based on evidence-based health information guidelines.
Main Results:
- Literature review revealed deficiencies in information on benefits, risks, alternatives, and numerical frequencies.
- Analysis of German forms showed consistent information on interventions and risks, but deficits in detailing alternatives and the option of doing nothing.
Conclusions:
- Significant deficiencies exist in informed consent forms, especially regarding risk communication.
- New standards are necessary to enhance patient understanding and promote well-informed decision-making.
- Structural changes in patient information processes are recommended.
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