Development of a patient reported outcome measure for gastrointestinal recovery (PRO-DIGI)

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.