Protocol for the development of a core outcome set on Invasive Placentation

Introduction: Invasive placentation is a life-threatening obstetrical complication that occurs when the placenta abnormally attaches to the uterine wall that may result in maternal and neonatal morbidity and maternal death. Despite its relative rarity, its incidence has risen dramatically in the past 50 years and is continuing to rise. Screening, diagnosing, and managing invasive placentation remains challenging, partially due to the many, often conflicting, outcomes reported in the literature. Prospective studies are necessary to address these knowledge gaps. In order for these studies to translate into improved patient care, and to meaningfully compare outcomes between studies, it is important to have a core set of outcomes considered important by patients and all other stakeholders involved in the care of these patients. This proposal outlines the protocol for the development of a core outcome set for invasive placentation.

Methods: Core outcome set development involves:
(1) Systematic Literature review to identify a list of outcomes reported in studies on invasive placentation;
(2) One-on-one interviews to identify important outcomes from the perspectives of patients, healthcare providers, and other stakeholders;
(3) Delphi Survey to arrive at a consensus on the outcomes that should comprise the core outcome; and
(4) Consensus Meeting to finalize the outcomes for inclusion in the core outcomes set.

Results: The results from each of the steps outlined in the Methods section will be reported individually and will culminate in the development of a core outcome for invasive placentation.

Conclusion: This project will result in the first core outcome set for invasive placentation that includes all relevant stakeholder perspectives. The core outcome set itself will contribute to research that can be optimally used and translated into improved clinical care. This knowledge may be used by future clinicians worldwide when providing care to women with invasive placentation and may improve both maternal and neonatal health outcomes.