Background: Heterogeneity among reported outcomes from enhanced recovery after cesarean delivery impact studies is high. This study aimed to develop a standardized enhanced recovery core outcome set for use in future enhanced recovery after cesarean delivery studies.
Methods: An international consensus study involving physicians, patients, and a director of midwifery and nursing services was conducted using a three-round modified Delphi approach (two rounds of electronic questionnaires and a third-round e-discussion) to produce the core outcome set. An initial list of outcomes was based on a previously published systematic review. Consensus was obtained for the final core outcome set, including definitions for key terms and preferred units of measurement. Strong consensus was defined as 70% or greater agreement and weak consensus as 50 to 69% agreement. Of the 64 stakeholders who were approached, 32 agreed to participate. All 32, 31, and 26 stakeholders completed Rounds 1, 2 and 3, respectively.
Results: The number of outcomes in the final core outcome set was reduced from 98 to 15. Strong consensus (70% or greater stakeholder agreement) was achieved for 15 outcomes. The core outcome set included length of hospital stay; compliance with enhanced recovery protocol; maternal morbidity (hospital re-admissions or unplanned consultations); provision of optimal analgesia (maternal satisfaction, compliance with analgesia, opioid consumption
or requirement and incidence of nausea or vomiting); fasting times; breast feeding success; and times to mobilization and urinary catheter removal. The Obstetric Quality of Recovery-10 item composite measure was also included in the final core outcome set. Areas identified as requiring further research included readiness for discharge and analysis of cost savings.
Conclusions: Results from an international consensus to develop a core outcome set for enhanced recovery after cesarean delivery are presented. These are outcomes that could be considered when designing future enhanced recovery studies.
This study aimed to develop a standardized enhanced recovery core outcome set for use in future enhanced recovery after cesarean delivery studies.
ContributorsPervez Sultan, M.B.Ch.B., Ron George, M.D., Carolyn F. Weiniger, M.D., K. El-Boghdadly, M.B.B.S., Perman Pandal, M.B.B.S., Brendan Carvalho, M.B.B.Ch., and CRADLE Study Investigators*
Disease Category: Pregnancy & childbirth
Disease Name: enhanced cesarean delivery recovery
Age Range: Unknown
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
A literature search was used to generate an initial list of outcomes. Then a 3-round delphi process was used to reach consensus on a final COS