Desirability Of Outcome Ranking (DOOR) for Obstetric Trials: Illustration and Application to the ARRIVE Trial
American journal of obstetrics and gynecology
desirability of outcome ranking; dyadic outcome; induction of labor
BACKGROUND: In randomized trials, one primary outcome is typically chosen to evaluate the consequences of an intervention while other important outcomes are relegated to secondary outcomes. This issue is amplified for many obstetric trials in which an intervention may have consequences for both the pregnant person and the child. In contrast, desirability of outcome ranking (DOOR), a paradigm shift for the design and analysis of clinical trials based on patient-centric evaluation, allows multiple outcomes - including from more than one individual - to be considered concurrently. OBJECTIVE: Our aim is to describe DOOR methodology tailored for obstetric trials and apply the methodology to maternal-perinatal paired (dyadic) outcomes in which both individuals may be affected by an intervention but may experience discordant outcomes (e.g., an obstetric intervention may improve perinatal but worsen maternal outcomes). STUDY DESIGN: This secondary analysis applies the DOOR methodology to data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network ARRIVE trial. The original analysis showed no statistical difference in the primary (perinatal composite) outcome, but a decreased risk of the secondary outcome of cesarean delivery with elective induction at 39 weeks. In the present DOOR analysis, dyadic outcomes ranging from spontaneous vaginal delivery without severe neonatal complication (most desirable) to cesarean delivery with perinatal death (least desirable) were classified into eight categories ranked by overall desirability by experienced investigators. Distributions of the DOOR were compared by estimating the probability of having a more desirable dyadic outcome with elective induction at 39 weeks of gestation than with expectant management. To account for various perspectives on these outcomes, a complementary analysis, called the partial credit strategy, was used in order to grade outcomes on a 100-point scale and estimate the difference in overall treatment scores between groups using a t-test. RESULTS: All 6096 participants from the trial were included. The probability of a better dyadic outcome for a randomly selected patient who was randomized to elective induction was 53% (95% CI: 51 - 54%) implying that elective induction led to a better overall outcome for the dyad when taking multiple outcomes into account concurrently. Furthermore, the DOOR probability of averting cesarean with elective induction was 52% (95% CI: 51 - 53%), which was not at the expense of an operative vaginal delivery or a poorer outcome for the perinate (i.e., survival with a severe neonatal complication or perinatal death). Randomization to elective induction also was advantageous in the majority of the partial credit score scenarios. CONCLUSION: DOOR methodology is a useful tool for obstetric trials as it provides a concurrent view of the effect of an intervention on multiple dyadic outcomes, potentially allowing for better translation of data for decision-making and person-centered care.
Sandoval, Grecio J.; Grobman, William A.; Evans, Scott R.; Rice, Madeline M.; Clifton, Rebecca G.; Chauhan, Suneet P.; Costantine, Maged M.; Gibson, Kelly S.; Longo, Monica; Metz, Torri D.; Miller, Emily S.; Parry, Samuel; Reddy, Uma M.; Rouse, Dwight J.; Simhan, Hyagriv N.; Thorp, John M.; Tita, Alan T.; and Saade, George R., "Desirability Of Outcome Ranking (DOOR) for Obstetric Trials: Illustration and Application to the ARRIVE Trial" (2023). GW Authored Works. Paper 3365.
Biostatistics and Bioinformatics