Standardizing abortion research outcomes (STAR): Results from an international consensus development study.
Clinical trials
Core outcomes
Medical abortion
Surgical abortion
Journal
Contraception
ISSN: 1879-0518
Titre abrégé: Contraception
Pays: United States
ID NLM: 0234361
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
21
04
2021
revised:
01
07
2021
accepted:
02
07
2021
pubmed:
18
7
2021
medline:
28
10
2021
entrez:
17
7
2021
Statut:
ppublish
Résumé
To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. 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. 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). Using robust consensus science methods we have developed a core outcome set for future abortion research. 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.
Identifiants
pubmed: 34273335
pii: S0010-7824(21)00224-9
doi: 10.1016/j.contraception.2021.07.004
pmc: PMC8609158
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
484-491Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
Copyright © 2021. Published by Elsevier Inc.
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