Reporting of management and outcomes in the hemolytic disease of the fetus and newborn: a systematic literature review

Abstract

Objective: This systematic literature review aimed to identify outcomes and provide a foundation for the development of a core outcome set in HDFN applicable for use in future clinical trials. Study design: The bibliographic databases MEDLINE, Embase, EBM Reviews, and EconLit were searched from 2005 until 2023. Primary research studies were included. Outcomes were systematically extracted from the publications’ abstract and categorized into maternal, obstetric, neonatal, long-term, and patient-reported outcomes (PROs). Results: 238 included studies reported 104 different outcomes. Outcomes related to HDFN-specific treatments were the most frequently reported across studies. Long-term outcomes as well as PROs were underutilized in the screened literature. Conclusion: This SLR showed that a substantial majority of outcomes reported in HDFN-related studies are clinically-centred. PROs and long-term outcomes beyond the neonatal phase are rarely reported in the current literature emphasizing the need to better incorporate those into future clinical practice.