Standardizing abortion research outcomes (STAR): results from an international consensus development study.

Abstract

OBJECTIVE\nTo develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.\n\n\nSTUDY DESIGN\nWe extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After two rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings.\n\n\nRESULTS\nWe entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 (87%) invitees provided responses (203 complete responses) for round one and 118 of 218 (42%) completed round two. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients experience of abortion); two outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and two apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity).\n\n\nCONCLUSION\nUsing robust consensus science methods we have developed a core outcome set for future abortion research.