Standardizing Abortion Research Outcomes (STAR): Results From an International Consensus Development Study
- July 13th, 2021
- Abortion, general
- Whitehouse, K.C., Stifani, B.M., Duffy, J.M.N., Kim, C.R., Creinin, M.D., DePiñeres, T., Winikoff, B., Gemzell-Danielsson, K., Blum, J., Sherman, R.B., Lavelanet, A.F., Brahmi, D., Grossman, D., Tamang, A., Gebreselassie, H., Gomez Ponce de Leon, R., Ganatraa, B.
Contraception; 2021 Jul 13; S0010-7824(21): 00224-9. doi:10.1016/j.contraception.2021.07.004
Objective: To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.
Study design: We 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 2 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.
Results: We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. 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); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity).
Conclusion: Using robust consensus science methods we have developed a core outcome set for future abortion research.