Background
Pre-eclampsia is a serious complication of pregnancy and contributes to maternal
and offspring mortality and morbidity. Randomised controlled trials evaluating
therapeutic interventions for pre-eclampsia have reported many different outcomes
and outcome measures. Such variation contributes to an inability to compare,
contrast, and combine individual studies, limiting the usefulness of research to inform
clinical practice. The development and use of a core outcome set would help to
address these issues ensuring outcomes important to all stakeholders, including
patients, will be collected and reported in a standardised fashion.
Methods
An international steering group including healthcare professionals, researchers, and
patients, has been formed to guide the development of this core outcome set.
Potential outcomes will be identified through a comprehensive literature review and
semi-structured interviews with patients. Potential core outcomes will be entered into
an international, multi-perspective online Delphi survey. All key stakeholders,
including healthcare professionals, researchers, and patients will be invited to
participate. The modified Delphi method encourages whole and stakeholder group
convergence towards consensus ‘core’ outcomes. Once core outcomes have been
agreed upon it is important to determine how they should be measured. The truth,
discrimination, and feasibility assessment framework will assess the quality of
potential outcome measures. High quality outcome measures will be associated with
core outcomes. Mechanisms exist to disseminate and implement the resulting core
outcome set within an international context.
Discussion
Embedding the core outcome set within future clinical trials, systematic reviews, and
clinical practice guidelines could make a profound contribution to advancing the
usefulness of research to inform clinical practice, enhance patient care, and improve
maternal and offspring outcomes. The infrastructure created by developing a core
outcome set for pre-eclampsia could be leveraged in other settings, for example
selecting research priorities and clinical practice guideline development.