Title: Development of a patient reported outcome measure for gastrointestinal recovery (PRO-DIGI)
Funder: Department of Health and Social Care

Abstract: Background Gastrointestinal dysfunction is commonly seen after surgery, and also manifests itself in intestinal obstruction. During this time, the patient may experience a range of symptoms of acute intestinal failure, includings loss of motility and absorption. These may resolve at different rates during the period of gastrointestinal recovery. Trials in the area have conflicting results, partly due to the selection of clincian reported unidimensional outcomes. There is a clear need for a patient reported outcome measure (PROM) to record gastrointestinal recovery. Aims and Objectives To develop a PROM for gastrointestinal recovery. To identify a candidate longlist of items for inclusion in a PROM through semi-structured patient interviews, and test face validity with patients and an expert panel To develop a PROM using the approved long list Methods This study will be conducted in three stages with reference to FDA and ISOQoL guidelines. Stage 1: Five centres will undertake purposive sampling to identify patients who have undergone major intraabdominal surgery (including gastrointestinal, urological, and gynaecological) and patients treated for intestinal obstruction. It is expected that 40-60 participants will undergo a semi-structured interview to identify important items related to recovery of gastrointestinal function in order to reach thematic saturation. Interviews will be transcribed and coded using a framework methodology. This will generate allow us to construct a prototype questionnaire with an initial pool of items. Stage 2: The prototype questionnaire will be shown to a group of international experts in gastrointestinal recovery for assessment of face validity, using the QQ-10 questionnaire. This will then be tested with 20 patients treated for eligible conditions at five participating centres using the QQ-10. Stage 3: Upto 500 participants (depending on number of items on the questionnaire) will be recruited from 10 centres which offer gastrointestinal, urological, and gynaecological surgery. Participants will rate items on a Likert scale. Items will undergo factor analysis to reduce the number of items. This will present a shorter questionnaire with finalised scales. Timelines for delivery Ethical approvals/site set ups: Apr-Sep 2021 Stage 1 (interviews/questionnaire drafting): Oct 21-Jan 2022 Stage 2 (face validity): Feb -Apr 2022 Questionnaire amendments: May-Jul 2022 Stage 3 (item reduction/scale generation): Aug 2022-Jan 2023 Close out: Feb - Mar 2023 Total 24 months Anticipated Impact and Dissemination The PROM may be incorporated into routine data registries including the British Association of Urological Surgeons cystectomy database. We will work with additional ongoing audits where this may be of relevance including the National Bowel Cancer Audit and National Emergency Laparotomy Audit to investigate inclusion in their ongoing work. The PROM will be submitted to NICE for inclusion in future enhanced recovery documents. This will help patients by measuring and driving up standards. The PROM will be made available to researchers in the field to further assess tool and respondent characteristics in real-world settings. Peer reviewed publication and presentation at scientific meetings will be undertaken.

Lay abstract: Aim(s) of the research This research will develop a tool to help measure what patients think is important in the recovery of bowel function when they have had a condition which stops their bowel working properly. Background to the research Sometimes the gut can stop working properly, leading to a condition of acute intestinal failure. It means that the bowel cannot absorb fluid and nutrients from food or move bowel content forwards, to be passed eventually into the toilet. These conditions are deeply distressing for patients, causing bloating, pain, and vomiting. This can affect thousands of people each year in the UK, and typically occurs after abdominal surgery, or where the bowel becomes blocked by scar tissue. Research measures bowel function recovery in lots of different ways, and some are not important to patients. In order to help us understand treatments better, we would like to develop a patient reported outcome measure (PROM) which will let patients tell us about the aspects of their bowel recovery that are significant to them. Design and methods used The study will be conducted in three stages. Stage one includes interviews with 40 patients who experience acute intestinal failure. They will identify which aspects of this experience matter to patients, and things we might want to measure. This will generate a long-list of items which could be used to measure bowel recovery. Stage two will check that this list makes sense with 20 people who are recovering from one of the relevant conditions. In stage three, we will ask 500 patients who are recovering from abdominal operations or bowel obstruction to tell us how important each of the statements on the long-list is for measuring their bowel recovery. This will help us to reduce the list to less than 20 statements. This will provide us with a tool that can be used in routine practice Patient and public involvement The study team includes two patient representatives who both have experienced ileus or small bowel obstruction. They will be involved in managing and sharing the findings of the study. Patient involvement is integral to every stage of the research process in this proposed study, ensuring that the final PROM will be patient-driven and patient-focused. This will be achieved through the addition of a separate patient representative steering group, with three additional members of the public to provide input. Dissemination The tool will be made available to researchers to test how it works in different settings. It will be shared with quality improvement bodies to help improve the routine care of patients in relevant settings such as cancer and emergency surgery. We will tell people about this tool through publications, and presentations at scientific meetings.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: ORAL AND GASTROINTESTINAL