(475) Desirability Of Outcome Ranking (DOOR) Methodology Applied to a Trial of Induction versus Expectant Management
Thursday, February 9, 2023
4:00 PM – 5:30 PM
Objective: In randomized trials, one primary outcome is typically chosen while other important outcomes to evaluate the consequences of an intervention are relegated to secondary outcomes. Desirability of outcome ranking (DOOR) is a new paradigm for the design and analysis of clinical trials based on patient-centric values, and allows multiple outcomes to be taken into account. Our aim was to tailor and apply DOOR methodology to maternal-perinatal paired (dyadic) outcomes in which a pair of individuals may be affected by an intervention but may experience discordant outcomes (e.g. cesarean may improve neonatal outcome but worsen maternal outcome).
Study Design: We applied DOOR methodology using data from a randomized trial of elective induction of labor (IOL) at 39 weeks vs. expectant management (EM). The original analysis showed no difference in the primary (neonatal composite) outcome, but a decrease in the secondary outcome of cesarean delivery with IOL. In this analysis, dyadic outcomes ranging from spontaneous vaginal delivery without severe neonatal complication (most desirable) to cesarean delivery with perinatal death (least desirable, Table 1) were classified into eight categories ranked by overall desirability. Distributions of the DOOR were compared by estimating which intervention results in greater probability of having a more desirable dyadic outcome (i.e. DOOR point estimate above 50%).
Results: The probability of a better dyadic outcome for a randomly selected patient who underwent IOL vs. EM was 53% (95% CI: 51 – 54%) implying that IOL led to a better overall outcome for the dyad. Furthermore, the DOOR probability of averting cesarean with IOL was 52% (95% CI: 51 – 53%), which was not at the expense of a poorer outcome for the perinate (perinatal DOOR component probabilities did not differ significantly by intervention) (Figure 1).
Conclusion: DOOR methodology may be a useful tool for obstetric studies, given that it provides a more functional view of the impact of an intervention on dyadic outcomes, and thereby allows for better translation of data for decision-making and person-centered care.
Primary & Presenting Author(s)
GS
Grecio J. Sandoval, PhD (he/him/his)
for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network Rockville, Maryland, United States