Background Case reports and case series are a widely-used source of scientific evidence. Although usually associated with a low strength of evidence, they are ideal for narrating events observed during clinical practice. On the other hand, the existing gap in the scientific literature relative to maternal drug exposure, due to several constraints, justifies the use of case reports and case series as a method for generating evidence in these situations.
Purpose To develop an optimised method of reporting clinical cases of maternal drug exposure, with the goal of increasing the strength of evidence associated with these sources.
Material and methods A Medline search was performed in PubMed and other databases, and on the instructions provided by working groups and scientific journals, to analyse and compile guidelines for writing case studies. 79 cases of pregnant women exposed to drugs were examined to identify the most relevant reports.
In the second phase, medical and pharmacological information was analysed related to each type of clinical situation, to be included in clinical reports suitable for future publications.
Results Several guidelines to publishing case reports were obtained. Although considerably heterogeneous, it was possible to develop a reporting model. As part of the model, we included the most relevant general clinical and pharmacological data for reporting cases of maternal drug exposure. The model was applied to 5 cases of pregnant women exposed to antidepressants, since they were the most prevalent, 25 out of 79, and was evaluated with a tool to measure quality.
Conclusion Clinical records analysis showed the absence of relevant, systematic and consistent information to build a case report. We have developed an evidence-based method tailored to report cases of maternal drug exposure, useful not only to strengthen their evidence and quality, but also to systematically collect clinical and pharmacological data.
References and/or acknowledgements I thank the physicians from the Hospital for their cooperation.
No conflict of interest.
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