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.
Implications: Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.
Approximately 43.8 million abortions are performed annually worldwide. Nearly half of those abortions are performed unsafely. Complications of unsafe abortion are one of the main causes of maternal mortality globally. Studies addressing safe abortion practices report heterogeneous outcomes resulting in bias and making it difficult to draw meaningful conclusions across studies. Development and use of core outcome sets would help to improve the applicability of results and better address one of the most common procedures performed on women worldwide.
Katherine C Whitehouse, Bianca M Stifani, James M N Duffy, Caron R Kim, Mitchell D Creinin, Teresa DePiñeres, Beverly Winikoff, Kristina Gemzell-Danielsson, Jennifer Blum, Renee Bracey Sherman, Antonella F Lavelanet, Dalia Brahmi, Daniel Grossman, Anand Tamang, Hailemichael Gebreselassie, Rodolfo Gomez Ponce de Leon, Bela Ganatra, World Health Organization
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)
- Epidemiologists
- Governmental agencies
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Systematic review
Stage 1: Identify possible outcomes
• Systematic review: randomised controlled trials evaluating safe induced abortion practices
• Qualitative patient interviews: Recruitment of patients via patient representative groups in at least one developed country and one developing country. Patients to take part in semi-structured interviews to identify common themes and identify possible outcomes of abortion.
• Outcome inventory: create comprehensive list of outcomes gleaned from review and patient interviews
Stage 2: Determine Core Outcomes
• Delphi process: Invite key stakeholders to participate in survey assessment of possible outcomes to refine list and work towards consensus
• Consensus meeting: key stakeholders and experts convene to deliberate on final core outcome set, including in this discussion is quality assessment to determine how outcomes should be measured.