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A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.

James M N Duffy1, Janneke van 't Hooft2, Chris Gale3

  • 1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6NW, United Kingdom.

Pregnancy Hypertension
|December 13, 2016
PubMed
Summary
This summary is machine-generated.

Developing a standardized core outcome set for pre-eclampsia research will improve data comparability and clinical practice. This ensures patient-important outcomes are consistently collected and reported in trials.

Keywords:
Core outcome setModified Delphi methodPre-eclampsiaSemi-structured interviewsSystematic review

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Area of Science:

  • Obstetrics and Gynecology
  • Clinical Trial Methodology
  • Perinatal Health

Background:

  • Pre-eclampsia poses significant risks to maternal and offspring health.
  • Inconsistent outcome measures in pre-eclampsia trials hinder research synthesis and clinical application.
  • A standardized core outcome set is needed to ensure consistent data collection and reporting.

Purpose of the Study:

  • To develop and implement a consensus-based core outcome set for pre-eclampsia research.
  • To standardize outcome measurement in therapeutic intervention trials for pre-eclampsia.
  • To enhance the comparability and utility of research findings for clinical practice.

Main Methods:

  • An international steering group guided the process, involving healthcare professionals, researchers, and patients.
  • Potential outcomes were identified via literature review and patient interviews.
  • An international online Delphi survey with key stakeholders was used to reach consensus on core outcomes.
  • The truth, discrimination, and feasibility framework assessed potential outcome measures.

Main Results:

  • A consensus-based core outcome set for pre-eclampsia was developed.
  • High-quality outcome measures were identified and associated with the core outcomes.
  • A framework for dissemination and international implementation was established.

Conclusions:

  • Implementing the core outcome set in trials and guidelines will improve research utility and patient care.
  • Standardized outcomes will enhance maternal and offspring health outcomes in pre-eclampsia.
  • The developed infrastructure can support core outcome set development in other research areas.