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Standardizing abortion research outcomes (STAR): Results from an international consensus development study
Katherine C Whitehouse1, Bianca M Stifani2, James M N Duffy3
1The UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Contraception
|July 17, 2021
Summary
A core outcome set was developed for abortion research using a modified Delphi method. This standardized set of 15 outcomes will improve consistency in future abortion trials and systematic reviews.
Area of Science:
- Reproductive Health
- Clinical Trials Methodology
- Evidence-Based Medicine
Background:
- Abortion research often lacks standardized outcome measures, leading to heterogeneity in study results.
- This variability complicates the synthesis of evidence for systematic reviews and the development of clinical guidelines.
- A consensus-driven approach is needed to establish a core set of outcomes for abortion trials.
Purpose of the Study:
- To develop a minimum data set, or core outcome set (COS), for future abortion randomized controlled trials.
- To standardize outcome reporting in abortion research to enhance comparability and reduce heterogeneity.
- To improve the quality and utility of systematic reviews and clinical guidelines for abortion care.
Main Methods:
- A modified Delphi method was employed, involving experts in abortion research, clinical practice, and patient advocacy.
- Outcomes were extracted from systematic reviews of quantitative and qualitative abortion studies.
- Experts rated outcome importance via a 9-point Likert scale over two rounds, followed by consensus development meetings.
Main Results:
- Forty-two potential outcomes across 15 domains were initially considered.
- A final core outcome set of 15 outcomes was established through expert consensus.
- The set includes universally applicable outcomes (e.g., successful abortion, pain) and those specific to medical, surgical, or anesthesia-assisted abortion.
Conclusions:
- A robust core outcome set for abortion research has been successfully developed using consensus science methods.
- Standardized reporting of these core outcomes is recommended for future abortion trials, systematic reviews, and clinical guidelines.
- Adoption of this COS is expected to decrease trial heterogeneity and improve the overall quality of abortion research.
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