Presentation (CTI)

OBJECTIVES: Following major abdominal surgery, patients may experience significant gastrointestinal dysfunction, including post-operative ileus. Many clinical tools are used to measure this dysfunction, but there is no Patient-Reported Outcome measure specific to this group. The aim of this study was to develop a new PRO measure for this common condition.
METHODS: A four-phase approach was undertaken. Stage one used semi-structured interviews with 29 patients to explore experiences of gastrointestinal recovery and develop a draft questionnaire. Stage two solicited feedback from 18 patients and 15 clinical experts on the face validity of the proposed tool using the QQ10 (a questionnaire of questionnaires designed and validated to assess face validity). Stage three recruited 297 patients to complete the questionnaire. Principal Component Analysis reduced the items and identified the domain structure. Test-retest reliability and a pilot assessment of responsiveness were assessed in stage four in a sample of 100 and 68 patients respectively.
RESULTS: The interviews generated 27 themes across gastrointestinal recovery and general wellbeing. An initial questionnaire containing 43 items was developed. The QQ10 demonstrated high value and low burden, supporting face validity. Tests to reduce the items, and identify the domains structure resulted in a 15-item questionnaire across four domains (nausea, eating, wellbeing, and bowel function). Test-retest reliability showed ICC values >0.7 for all domains. Pilot responsiveness was demonstrated through differences in pre- and post-surgical scores.
CONCLUSIONS: The PRO-diGI is a PRO measure for gastrointestinal dysfunction after major abdominal surgery which shows good psychometric properties, and demonstrates face validity, reliability, and responsiveness. This now needs external validation to facilitate broader implementation.