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; breastfeeding 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.
There is no consensus regarding which outcome measures should be used to evaluate enhanced recovery after cesarean delivery (ERAC) protocol success within research studies.
We aim to define a standardised core outcome set which can be used by researchers to evaluate ERAC protocol efficacy within future randomized controlled, observational and retrospective studies.
Pervez Sultan, Ron George, Carolyn F Weiniger, K El-Boghdadly, Perman Pandal, Brendan Carvalho; CRADLE Study Investigators
Disease Category: Pregnancy & childbirth
Disease Name: Maternity care
Age Range: 18 - 120
Sex: Female
Nature of Intervention: Procedure
- Clinical experts
- COS for clinical trials or clinical research
- Delphi process
- Semi structured discussion
- Systematic review
We will invite ERAC experts to participate in 2 rounds of Delphi questionnaires followed by a "round table" discussion to finalize a core outcome set.
Experts will be selected as follows:
Above investigators
Corresponding authors of the 12 published ERAC studies
All authors of a recent consensus statement published by the Society for Obstetric Anesthesia and Perinatology regarding ERAC
Each member of the ERAC society task force will be asked to recommend an obstetrician with expertise in the area
First and last authors of the ERAS society guidelines (Parts 1-3) surrounding ERAC, published in American Journal of Obstetrics and Gynecology
Corresponding authors of the ERAS society guidelines surrounding ERAC will also be invited to recommend another expert in ERAC, (with experience in evaluating / assessing impact of ERAC)
First and last authors of any published article / review identified in a literature search regarding ERAC