Development of a patient-reported outcome measure for gastrointestinal recovery after surgery (PRO-diGI)

Lee, Matthew J., Baker, Daniel M., Hawkins, Debby, Blackwell, Sue, Arnott, Robert, Harji, Deena, Thorpe, Gabrielle, Chapman, Stephen J. and Jones, Georgina L. and the PRO-diGI Collaborators (2025) Development of a patient-reported outcome measure for gastrointestinal recovery after surgery (PRO-diGI). British Journal of Surgery, 112 (4). ISSN 0007-1323

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Abstract

Background: After major abdominal surgery, patients may experience significant gastrointestinal dysfunction, including postoperative ileus. Many clinical tools are used to measure this dysfunction, but there is no patient-reported outcome measure (PROM) specific to this group. The aim of this study was to develop a new PROM for this common condition. Methods: A four-stage approach was undertaken. Stage 1 used semi-structured interviews with 29 patients to explore experiences of gastrointestinal recovery and develop a draft questionnaire. Stage 2 solicited feedback from 18 patients and 15 clinical experts on the face validity of the proposed tool using the Questionnaire on Questionnaires (QQ-10). Stage 3 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 4 in a sample of 100 patients and in a sample of 68 patients respectively. Results: The interviews generated 26 subthemes across gastrointestinal recovery and general well-being. An initial questionnaire containing 44 items was developed. The QQ-10 demonstrated high value and low burden, supporting face validity. Tests to reduce the items and identify the domain structure resulted in a 15-item questionnaire across four domains (nausea, eating, well-being, and bowels). Test-retest reliability showed intraclass correlation coefficient values ≥0.7 for all domains. Pilot responsiveness was demonstrated through differences in pre- and post-surgical scores. Conclusion: PRO-diGI is a PROM for gastrointestinal dysfunction after major abdominal surgery that shows good psychometric properties and demonstrates face validity, reliability, and responsiveness. This now needs external validation to facilitate broader implementation.

Item Type: Article
Additional Information: Data availability statement: The research team will consider reasonable requests for data sharing of unidentified quantitative data sets for appropriate methodological reasons. The corresponding author should be contacted in the first instance. In addition, the study protocol and other documents, including template consent forms, may be accessed by contacting the corresponding author. Funding information: This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR201492). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Uncontrolled Keywords: gastrointestinal function,gastrointestinal surgery,patient reported outcome measure
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Depositing User: LivePure Connector
Date Deposited: 30 Jun 2025 09:30
Last Modified: 30 Jun 2025 09:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/99760
DOI: 10.1093/bjs/znaf055

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