gms | German Medical Science

Introduction: More than two years since the beginning of the pandemic, there is still a lack of research investigating women’s health [1]. However, according to previous literature, women have experienced menstrual changes following COVID-19 vaccinations [2], [3], [4]. Most large-scale studies excluded questions about menstrual cycle changes and its relation to COVID-19 [1]. In this paper, we show how we created a questionnaire specifically focusing on menstrual changes and COVID-19-time specific events to collect interoperable data for international use and further analysis [5].

Methods: To obtain questionnaire items, we used already publicly existing questionnaires such as the common Menstrual History Questionnaire [6], the RHINESSA WOMEN’S QUESTIONNAIRE by Helse Bergen Gesundheit Bergen HF, Universitätsklinik Haukeland [7], the COVIM - Determination and use of SARS-CoV-2 immunity questionnaire [8] and other menstrual history questionnaires [9] which are identified by LOINC [10]. Obstetrician-Gynecologists were involved to identify appropriate questions that would pose menstrual change related questions. In order to have the semantic foundation of terms to be chosen, we closely collaborated with two obstetrician-gynaecologists via online video calls and revised excel sheets where we collected the reviewed questions/terms, to comprise the semantic depth of the questionnaire. Finally, questions and questionnaire responses were semantically coded with existing international standards such as LOINC and SNOMED CT codes to foster data standardization in the questionnaire response.

Results: Out of the existing questionnaires we identified 56 questions for our interoperable questionnaire containing the following sections: 5 registration questions, 45 initial “current status” questions and 6 follow-up questions. The questionnaire serves the English and German language.

Within the registration section one out of five questions (20%) and within the “current status” section 53% (24/45) could be semantically coded. No semantic codes were identified in the follow-up section (0/6).

Discussion and conclusion: It was noticeable that semantic interoperability on the menstrual cycle did not yet include COVID-19 related terms. The lacking question and answer options of international semantic standards regarding menstrual cycle and women's health, clearly highlight the need for extending semantic interoperability towards menstrual changes. Therefore, we focused on the questions and responses not yet represented in LOINC terms. Thus, 31 questions pertaining around menstrual changes with COVID-19-time specific answer and question terms will be submitted for codes to LOINC (Regenstrief Institute) [10] to obtain a complete questionnaire, facilitating interoperable standardized data capturing. The survey period is intended to be six months long with six-week intervals for questioning.

The ultimate goal is the development of a mobile app for effective dissemination of the questionnaire. To accomplish syntactic interoperability, answers will be coded in HL7 FHIR increasing usage and data sharing of the questionnaire with other researchers. This framework is inspired by the NUM-COMPASS project [11]. The project established a coordination and technology platform for pandemic applications and where the German Corona Consensus Dataset (GECCO) finds use. The GECCO Dataset already provides some questions found in the Menstrual Questionnaire, which can be used as a reference for syntactic and semantic interoperability [12].

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.