Use of the Optimality Index-United States in perinatal clinical research: a validation study.

The objective of this study was to assess the validity and observed effect size of a new instrument, the Optimality Index-United States (OI-US), for use in perinatal clinical research. Using a large, hospital-based, midwifery service clinical database that included complete obstetric data for 3425 women, we examined discriminant validity and the effects of two different scoring methods used with the OI-US. Discriminant validity was confirmed by comparing OI scores for women who remained low risk and did not require physician involvement in their care (OI score mean = 84%; standard deviation [SD] = 8%) compared to those whose condition changed to require physician involvement in their care (mean = 71%; SD = 10%; P < .001). Two methods of scoring the OI-US were compared, finding no significant difference and suggesting that the types of data available and the research question can drive this decision. Finally, effect size was calculated by two methods: Cohen's d (-1.4) and the effect size correlation (r = -0.548), the latter of which corresponds to a d of -1.3, both resulting in a similarly large effect size estimation. The OI-US is a new instrument that shows promise for use in perinatal clinical research, particularly when assessing more subtle clinical differences in outcomes between study groups.