JMIR Publications

ABSTRACT

Background:

Since 2008, the open-access internet portal embryotox.de provides evidence-based information on drug safety during pregnancy and breastfeeding. The German website, designed for healthcare professionals, comprises factsheets about 400 drugs and is maintained by the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy at the Charité – Universitätsmedizin Berlin. In 2024, it was accessed more than five million times.

Objective:

This mixed-methods study aimed to evaluate who is using the website, how it is being used, and to what extent it meets users’ needs.

Methods:

Data were collected between 2022 and 2023. Online questionnaire 1 contained questions on user characteristics, clinical specifics of use, comprehensibility and changes of risk assessment or drug therapy following factsheet use. Answers included multiple choice options or ratings on a Likert Scale from 0 (not at all) to 10 (fully). Online questionnaire 2 collected data on decision-making based on Embryotox factsheets. Answers included multiple choice options or ratings on a Likert Scale. Data from both questionnaires were analyzed using descriptive statistics. Qualitative data were generated through semi-structured phone interviews, with interviewees sampled from the main user groups identified in questionnaire 1, i.e. patients, physicians, pharmacists and midwives. Kuckartz’s content analysis was employed to analyze data on users' trust and the functions of website use for different stakeholder groups.

Results:

Questionnaire 1 was completed by 14,562 users, including 10,860 patients, 1,676 physicians, 550 pharmacists and 364 midwives. Of the physicians, 27.2% (n=456/1,676) were obstetricians/gynecologists and 22.7% (n=381/1,676) general practitioners. For physicians, mean of comprehensibility ratings was 9.39 (pharmacists 9.25, midwives 9.14), for patients 8.80. Following factsheet use, 66.6% (n=9,694/14,562) of all users changed their perception of risk, and 22.3% of users in a specific treatment setting (n=2,252/10,083) considered changing drug treatment. Qualitative content analysis revealed that users highly trusted the information in the factsheets for a number of reasons, including recommendations from other users, the scientific basis of the website, and the authority of the Embryotox Center as a university-based specialist department for drug safety in pregnancy and lactation. Functions of factsheet use differed depending on the stakeholder group. A total of n=793 users, mostly physicians and patients, fully completed questionnaire 2, specifying typical clinical situations and benefits of factsheet use in the context of shared decision-making. Benefits included facilitating the decision-making process and increasing confidence in it.

Conclusions:

The information provided in the Embryotox factsheets was generally perceived as both comprehensible and trustworthy, supporting and facilitating the decision-making process. Clinical Trial: -