SP7.3 Development of a Patient Reported Outcome measure for GastroIntestinal recovery: The PRO-diGI study

Abstract Background Patients undergoing abdominal surgery often experience gastrointestinal dysfunction. Recovery of gastrointestinal function is poorly measured. There is a need for a patient reported outcome measure to assess gastrointestinal recovery. The first stage of development requires qualitative work to identify key concepts. Methods The PRO-diGI study consisted of three phases: Phase 1: Qualitative interviews of patients admitted to hospital for major gastrointestinal, gynaecological, or urological surgery, or with intestinal obstruction. Phase 2: Development of questionnaire and face validity testing with patients as in Phase 1, and expert clinicians internationally. Phase 3: The questionnaire was distributed to eligible patients. Participants completed the questionnaire as soon after surgery as they were able. Exploratory factor analysis was performed to confirm the structure of the questionnaire and reduce the number of items. Results Phase 1: 29 patients were interviewed, and reported 26 key symptoms or experiences across 6 themes including impact on life, mental health, and general physical wellbeing, diet and appetite, abdominal symptoms, nausea and vomiting, and bowel function. Phase 2: 18 patients and 15 clinicians assessed a 44-item questionnaire, confirming good face validity. Phase 3: 297 participants were recruited. Factor analysis identified 20 questions related to enjoyment of food, ability to eat and drink, bowel function, nausea and vomiting, and general wellbeing, for inclusion in the final tool. The final tool shows correlation with self-rating of gut function, GI-2, and operative approach. Discussion This study has developed a multi-dimensional patient reported outcome measure which can be used in studies of gastrointestinal recovery.