Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery (PRO-diGI)

People who undergo surgery, or develop intestinal obstruction will spend a period of time without normal bowel function. This might extend beyond the normal measures of passage of flatus or tolerance of diet. This study will take a three stage approach to develop a patient reported outcome measure for gastrointestinal recovery.

Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal surgery, or conservatively managed intestinal obstruction. These interviews will identify key themes and ideas to develop the questionnaire.

Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10 questionnaire to aid assessment. The questionnaire may be edited after this.

Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or treatment for intestinal obstruction. Basic demographics will also be collated. Item reduction and scale refinement will be undertaken using this dataset. This will provide a PROM of gastrointestinal recovery which is ready for validation.

Study Overview

• Status: Recruiting
• Conditions: Ileus; Small Bowel Obstruction; Intestinal Failure

Detailed Description

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, including 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 clinician 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 long-list 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 (Food and Drug Administration) and ISOQoL (International Society for Quality of Life Research) 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 quality-10 item) 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.

• Study Type: Observational
• Enrollment (Anticipated): 560

Contacts and Locations

• Study Contact: Name: Debby Hawkins, PhD; Phone Number: 01142434343; Email: debby.hawkins@nhs.net

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Recruiting
      • Sheffield Teaching Hospitals NHS Foundation Trust
      • Principal Investigator: Matthew J Lee, MBChB PhD
      • Contact: Debby Hawkins, PhD; Phone Number: +44 0114 2434343; Email: debby.hawkins@sth.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or gynaecological indications OR patients being treated for intestinal obstruction regardelss of aetiology.

Description

Inclusion Criteria:

Adult patients (aged 18+) admitted to hospital for one of the following reasons will be eligible to participate:

• Undergoing major elective gastrointestinal surgery (e.g. colorectal resection, gastric resection, liver or pancreatic resection)
• Emergency laparotomy for non-trauma indication
• Patients undergoing intra-abdominal surgery for non-gastrointestinal indications e.g.cystoprostatectomy, prostatectomy, nephrectomy, hysterectomy, or oophorectomy.
• With a diagnosis of intestinal obstruction (small or large bowel).
• Participants are permitted to participate in another study or trial in addition to PRO-DIGI

Exclusion Criteria:

• Non conversationaI standard of English
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Phase 1; Qualitative interviews with patients to generate thematic framework and questionnaire
Phase 2; Face validity assessment of questionnaire
Phase 3; Completion of questionnaire to refine scale and item list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of interviews (stage one)	completions of interview by group 1	Within one month of treatment
Completion of questionnaire (stage three)	completion of questionnaire by group 3	Within two weeks of treatment
Completion of face validity assessment (stage two)	Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2	Within one month of treatment

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Sheffield
• Investigators: Principal Investigator: Matthew Lee, PhD, University of Sheffied and Sheffield Teaching Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: surgery; PROM
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: STH20670; NIHR 201492 (Other Grant/Funding Number: National Institute for Health Research RfPB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Anonymised transcriptions of phase one interviews will be made available on our institution open access data repository. Other data relates to refinement of the PROM and is not relevant outside of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No