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We thank our correspondents for their critical discussion of our article (1). We will address some of the issues raised in detail.

Ascertaining the competence to give consent is an important component of the pre-procedure discussion and should be documented in the consent form. If the patient does not have competence, the pre-procedure discussion involves their legal representative, and the decision will have to be made by proxy.

The subject of our analysis comprised the written materials and not the entire consent process. For this reason we were not able to consider the aspect of time expenditure. From the patient’s perspective, time expenditure matters far less than a comprehensive and comprehensible pre-procedure discussion. Consent forms that meet the criteria for evidence-based health information can—in our opinion—help to put this aspiration into practice more easily, since crucial information for the pre-procedure discussion is already available in a comprehensible format.

There is no validated instrument for the purpose of evaluating consent forms that might make classification feasible. For this reason we presented our results in a purely descriptive form. The criteria we applied were defined on the basis of an evidence-based and consensus based guideline for evidence-based health information. According to these criteria, the consent forms we investigated were not suitable for enabling an informed decision. In spite of certain differences in quality, we would not rate any of the consent forms as very good. In all forms, sources of information were not cited, and an appropriate numerical presentation of harms and benefits was missing. Our analysis does not allow for any general conclusion about the quality of all consent forms, but it is fair to assume that the results are generalizable to a certain extent.

In a process of shared and informed decision-making, patients should weigh up on the basis of the best available evidence which options meet their own preferences and ideas best. We therefore agree that the pre-procedure discussion should consist of more than evidence-based facts. But the facts cannot be omitted because they form the basis of the individual weighing-up process. Especially numerical data can help to assess the probabilities for the possible benefits and harms of a medical measure more realistically (2, 3). It was also shown that anxiety or uncertainty do not increase if more information is provided in the context of the pre-procedure discussion (4).

With regard to the package information leaflets mentioned, it was recently ascertained that even those working in the healthcare professions do not understand the information on adverse effects (5). For this reason, we would not use such package leaflets for comparison if appropriate and comprehensible risk communication is needed. Consent forms are probably in many cases used only for the purposes of consent that is legally valid. However, the objective should be an informed decision. For this reason, we make a plea for new standards, in order to ensure that patients receive, at the right time, the information they need in order to make an individual informed decision.

DOI: 10.3238/arztebl.2018.0637

On behalf of the authors

Julia Lühnen
MIN-Fakultät, Gesundheitswissenschaften, Universität Hamburg
julia.luehnen@uni-hamburg.de

Conflict of interest statement

The author declares that no conflict of interest exists.

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
2.
Berry D, Raynor T, Knapp P, Bersellini E: Over the counter medicines and the need for immediate action: a further evaluation of European Commission recommended wordings for communicating risk. Patient Educ Couns 2004; 53: 129–34 CrossRef
3.
Man-Son-Hing M, O‘Connor AM, Drake E, Biggs J, Hum V, Laupacis A: The effect of qualitative vs. quantitative presentation of probability estimates on patient decision-making: a randomized trial. Health Expect 2002; 5: 246–55 CrossRef MEDLINE PubMed Central
4.
Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B: Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev 2013; 7: CD009445.
5.
Mühlbauer V, Mühlhauser I: Understanding adverse drug reactions in package leaflets—an exploratory survey among health care professionals. BMC Health Serv Res 2015; 15: 505 CrossRef MEDLINE PubMed Central
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
2.Berry D, Raynor T, Knapp P, Bersellini E: Over the counter medicines and the need for immediate action: a further evaluation of European Commission recommended wordings for communicating risk. Patient Educ Couns 2004; 53: 129–34 CrossRef
3. Man-Son-Hing M, O‘Connor AM, Drake E, Biggs J, Hum V, Laupacis A: The effect of qualitative vs. quantitative presentation of probability estimates on patient decision-making: a randomized trial. Health Expect 2002; 5: 246–55 CrossRef MEDLINE PubMed Central
4. Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B: Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev 2013; 7: CD009445.
5. Mühlbauer V, Mühlhauser I: Understanding adverse drug reactions in package leaflets—an exploratory survey among health care professionals. BMC Health Serv Res 2015; 15: 505 CrossRef MEDLINE PubMed Central

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