Table2_Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project.DOCX

To assess the risk of exposure to a medicinal product during pregnancy in an individual case report, the necessary information should be present, complete and clearly described. Previously designed grading tools were not developed for pregnancy pharmacovigilance data. This study aims to identify the elements that are necessary to assess of the quality of information for risk assessment of medicinal products used during pregnancy. This is a first step in the development of a validated method to assess the clinical quality of case reports in pregnancy pharmacovigilance data. Potential information elements were determined by means of an expert focus group discussion and a survey based on its outcome. This provided an overview of possible information elements to be selected. For the final selection of the elements, a second survey and subsequent focus group discussion was used. Twenty-one information elements within seven categories were identified: information related to the association itself, the event, exposure to the medicinal product, maternal factors, pregnancy, labour, and the child. This study identified elements considered necessary in the assessment of quality of information of case reports in pregnancy pharmacovigilance data, via an extensive four-step process.

为评估个体病例报告（case report）中受试者妊娠期药品（medicinal product）暴露风险，相关必要信息应完整、清晰且齐备。此前设计的分级工具并非针对妊娠期药物警戒（pregnancy pharmacovigilance）数据开发。本研究旨在明确用于妊娠期用药风险评估的信息质量评价所需的核心要素。本研究是开发用于评价妊娠期药物警戒数据中病例报告临床质量的经过验证的方法的第一步。研究首先通过专家焦点小组讨论（focus group discussion）及基于该讨论结果的问卷调查，确定潜在信息要素，由此梳理出可供遴选的各类潜在信息条目。为最终确定要素清单，本研究又开展了第二轮问卷调查及后续焦点小组讨论。最终明确了7大类共21项信息要素，分别涉及关联本身、不良事件、药品暴露情况、母体因素、妊娠状况、分娩过程及新生儿情况。本研究通过一套系统性四阶段流程，明确了妊娠期药物警戒数据中病例报告的信息质量评价所需的核心要素。