Desirability Of Outcome Ranking (DOOR) Analyses for the NICHD MFMU and MOMS Studies - The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network was set up in 1986 and continues to conduct major practice-changing clinical trials in maternal and fetal medicine. Primary results of the MFMU Network’s trials have amassed over 7,400 citations (average 320 citations per primary manuscript) and are frequently referenced in the American College of Obstetricians and Gynecologists Practice Bulletins. The NICHD also supported the Management of Myelomeningocele Study (MOMS), a groundbreaking trial of surgical repair of the spina bifida defect before the baby is born versus the usual postnatal surgical repair and the follow-up study of the children (MOMS2). Results from obstetrical clinical trials can be challenging to understand and inform clinical practice since the effects of an intervention on the outcomes of the birthing individual and their perinate may be discordant. For example, for any individual trial participant and their perinate (dyad), an obstetrical intervention may improve a perinatal outcome but worsen a maternal outcome. In practice, this imbalance of benefit may increase the complexity of decision-making and back-and-forth discussions between clinical provider and patient due to various understandings and perceptions of treatment strategies and outcomes for the pregnant person or perinate. The Desirability Of Outcome Ranking (DOOR) is a paradigm shift for the design and analysis of clinical trials that can consider both maternal and perinatal outcomes concurrently to comprehensively and objectively evaluate the effects of interventions on the overall success of the pregnancy. The partial credit strategy, part of the DOOR analysis, assesses the robustness of trial results which further allow any individual to evaluate results with respect to their own perspective on outcomes. The primary goal of this research project is to utilize the DOOR methodology to generate and disseminate clearer and more meaningful interpretations of trial results to advance understanding from these NICHD funded studies (MFMU and MOMS) that have informed clinical practice. Providing more interpretable results is the fundamental basis for understanding how interventions lead to healthier pregnancy and infant outcomes, both of which are topics directly related to the NICHD’s mission. Results from these DOOR analyses of existing high-impact studies will enhance the global understanding of how obstetrical interventions lead both the birthing individual and their perinate towards healthier and desirable outcomes and will provide the foundational education and knowledge for future obstetrical trials.
