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.
Katherine C. Whitehouse, Bianca M. Stifani, James M.N. Duffy, Caron R. Kim, Mitchell D. Creinin, Teresa De Piñeres, Beverly Winikofff, Kristina Gemzell-Danielsson, Jennifer Blum, Renee Bracey Sherman, Antonella F. Lavelanet, Dalia Brahmi, Daniel Grossman, Anand Tamang, Hailemichael Gebreselassie, Rodolfo Gomez Ponce de Leon, BelaGanatra
Disease Category: Gynaecology, Pregnancy & childbirth
Disease Name: Abortion
Age Range: 10 - 60
Sex: Female
Nature of Intervention: Management of care, Operative and non-operative management, Postoperative management , Surgery
- Clinical experts
- Consumers (patients)
- Governmental agencies
- Researchers
- Service providers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review