A core outcome set for clinical studies of adhesive small bowel obstruction

Background

Adhesive Small bowel obstruction (ASBO) is a common surgical emergency condition. Research in the field is plentiful, however inconsistency in outcome reporting makes comparisons challenging. The aim of this study was to define a core outcome set (COS) for studies of ASBO.

Methods

The long list of outcomes was identified through systematic review, focus groups across different geographical regions. A modified Delphi consensus exercise of 3 rounds was undertaken with stakeholder groups (patients and clinicians). Items were rated on a 9-point Likert scale. Items exceeding 70% rating at 7-9 were passed to the consensus meeting. New item proposals were invited in Round 1. Individualized feedback on prior voting compared to other participants was provided. An international consensus meeting was convened to ratify the final COS.

Results

In round one, 56 items were rated by 118 respondents. 18 items reached consensus, and respondents proposed an additional 10 items. Round two was completed by 90 respondents, and 9 items achieved consensus. In round three, 80 surveys were completed; one item achieved consensus, and five borderline items were identified. The final COS included 26 outcomes, mapped to the following domains: Interventions, need for stoma, septic complications, return of gut function, patient reported outcomes, and recurrence of obstruction, as well as mortality, failure to rescue, and time to resolution.

Conclusion

This COS should be used in future studies in the treatment of adhesive SBO. Further work to define a core measurement set is needed to identify the optimum tools to measure each outcome.