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Composite adverse outcomes in obstetric studies: a systematic review
Dylan Herman1,2,3, Kar Yee Lor4, Abdul Qadree5
1Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.
BMC Pregnancy and Childbirth
|February 6, 2021
Summary
Composite outcomes in obstetric trials are common but often lack consistency. Future research should use methods like concept mapping to improve the development of these critical outcome measures.
Area of Science:
- Obstetrics and Gynecology
- Clinical Trial Methodology
- Reproductive Health Research
Background:
- Composite outcomes are increasingly utilized in obstetric randomized controlled trials (RCTs).
- A critical appraisal of their use in obstetric RCTs is needed to identify limitations and propose solutions.
- This systematic review focuses on the application and development of composite outcomes in pregnancy research.
Purpose of the Study:
- To critically appraise the use of composite outcomes in obstetric RCTs.
- To identify limitations in the current construction and application of composite outcomes.
- To provide potential solutions for future research in developing better composite outcomes.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) published between 1999 and 2019.
- Searches conducted in Medline, Embase, Cochrane Databases, and clinicaltrials.gov using pregnancy and composite outcome terms.
- Duplicate screening and data extraction followed by descriptive synthesis and critical appraisal.
Main Results:
- 156 RCTs reporting 181 composite outcomes were included, primarily related to maternal and perinatal morbidity/mortality.
- Composite outcomes varied widely, including 2 to 16 components often dissimilar in severity, frequency, and relevance.
- Many composite outcomes failed to incorporate patient perspectives, holistic health views, or consider both mother and fetus.
Conclusions:
- Composite outcomes are increasingly used for conclusions and recommendations in obstetric RCTs.
- Significant inconsistencies exist in component selection and measurement of composite adverse obstetric outcomes.
- Novel methods like concept mapping may improve the development of composite adverse obstetric outcomes for future studies.
Keywords:
Adverse pregnancy outcomesComposite endpointsComposite outcomesObstetric trialsSystematic reviewMore Related Videos
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