Abstract

Self-Controlled Case Series (SCCS) and Self-Controlled Risk Interval (SCRI) study designs are types of studies where cases act as their controls. They are commonly used by pharmacovigilance to study rare events. There is no existing tool for the assessment of the methodological quality of such studies. Critical appraisal in primary and secondary studies is crucial as it enables the reader to evaluate how the study was elaborated and take this into consideration while analyzing the evidence presented. This paper presents a proposal of an instrument that has been adapted from an already existing tool used for cohort studies and it combines the elements of this tool and the premises of the SCCS and SCRI study designs. It is expected that the tool will help researchers and readers in critically appraising SCCS and SCRI study designs.