Harmonisation of research data for congenital Zika syndrome: need for core data sets for epidemic-prone infectious diseases

Abstract

Purpose: To reduce the delay in the clinical research response during outbreaks; we sought to define core variables for research on Congenital Zika Syndrome (CZS) based on the experiences of research responders in Recife, Brazil - a Zika affected region. Methods & Materials: We employed a qualitative methodology with interviews and document review. Two sets of case record forms (CRFs) designed at the start of the Zika epidemic were reviewed; one developed by the Microcephaly Epidemic Research Group (MERG) in Recife and the other by ISARIC (International Consortium for Severe Acute Respiratory and Emerging Infections Consortium) and her collaborators. Semi-structured qualitative interviews were conducted to explore the views of the MERG team on core domains for research on CZS. Thematic discourse analysis was used to look for similarities and differences in the data. Results: The document review indicated that the CRFs complemented each other and merging the domains from both sets of questionnaires produced a relatively comprehensive data set. The participants proposed a minimum set of domains for observational research on CZS and divided these into clinical and epidemiological domains based on the type of data generated. Cross-cutting themes which emerged were the importance of the research context and timing of research on the structure, construct and content of items in each domain. Participants underscored the need for dynamic CRFs at the start of an epidemic; because outbreaks are rapidly evolving, and questionnaires need to be adaptable to accommodate new information during the outbreak. Conclusion: Developing a standardised case record form for clinical research involves various steps, each of which takes time. The domains recommended lend themselves to other arbovirus infections or infections with the potential for mother-to-child transmission. The study strengthens the need for an agreed core set of variables for various clinical syndromes and unique issues such as pregnant women and children. A methodology on how to decide on the data variables would be useful. A future study could be to identify what the generic research questions might be, to further refine the core data set in advance of an outbreak, given that CRFs should ideally be linked to predefined research questions and protocols.