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

Autor: James Duffy, Bianca M. Stifani, Jennifer Blum, Anand Tamang, Kristina Gemzell-Danielsson, Beverly Winikoff, Caron Kim, Bela Ganatra, Katherine C. Whitehouse, Teresa DePiñeres, Mitchell D. Creinin, Dalia Brahmi, Rodolfo Gómez Ponce de León, Hailemichael Gebreselassie, Antonella Lavelanet, Daniel Grossman, Renee Bracey Sherman
Rok vydání: 2021
Předmět:
medicine.medical_specialty
Consensus
Delphi Technique
medicine.medical_treatment
Clinical Trials and Supportive Activities
Clinical Sciences
Delphi method
Surgical abortion
Reproductive health and childbirth
Abortion
law.invention
Paediatrics and Reproductive Medicine
Clinical trials
Randomized controlled trial
Clinical Research
Pregnancy
law
Surveys and Questionnaires
Medical abortion
Health care
Humans
Medicine
Original Research Article
Core outcomes
Obstetrics & Reproductive Medicine
Minimum Data Set
business.industry
Induced
Obstetrics and Gynecology
Abortion
Induced
Clinical trial
Good Health and Well Being
Treatment Outcome
Systematic review
Reproductive Medicine
Research Design
Family medicine
Public Health and Health Services
Female
Patient Safety
business
Systematic Reviews as Topic
Zdroj: Contraception
Contraception, vol 104, iss 5
ISSN: 0010-7824
Popis: 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.
Databáze: OpenAIRE
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