Patient Reported Outcomes of Gastrointestinal Recovery (PRO-diGI)

Gastrointestinal dysfunction affects a significant proportion of patients following major abdominal surgery, with up to 30% experiencing symptoms such as nausea, vomiting, obstipation, and abdominal pain. These symptoms, commonly referred to as postoperative ileus, contribute to delayed recovery, increased hospital stays, and elevated healthcare costs. Despite the prevalence of these issues, there has been no validated Patient-Reported Outcome Measure (PROM) specifically designed to assess gastrointestinal recovery in this context.

Existing tools for gastrointestinal-related quality of life are typically designed for chronic conditions and outpatient settings, failing to capture the acute postoperative experience. Clinical assessments often rely on binary indicators such as the passage of flatus, which do not reflect the multidimensional nature of recovery.

The PRO-diGI was developed to address this gap, offering a condition-specific PROM for gastrointestinal recovery after surgery. The development followed a rigorous four-stage process:
1. Item Generation – Semi-structured interviews with 29 patients across five UK hospitals identified 26 subthemes and informed a draft 44-item questionnaire.
2. Face Validity Assessment – Feedback from 18 patients and 15 clinical experts confirmed the tool’s acceptability and relevance.
3. Domain Development and Item Reduction – Principal component analysis (PCA) refined the questionnaire to 15 items across four domains.
4. Reliability and Responsiveness Testing – Test–retest reliability showed intraclass correlation coefficients ≥0.7 across all domains.

The development was guided by the COSMIN taxonomy and GRIPP-2 SF framework, with extensive patient and public involvement (PPI) throughout. Collaborators included health psychologists, colorectal nurses, surgeons, and lay representatives from institutions such as the University of Birmingham, University of Sheffield, Leeds Teaching Hospitals, and Leeds Beckett University.

The PRO-diGI is copyright 2024 by Sheffield Teaching Hospitals and licensing is managed by InSpired Health Outcomes Ltd, Oxford, UK.
 

A simple and flexible scoring system is used throughout the PRO-diGI, allowing for both individual domain scores and an overall assessment of gastrointestinal recovery.

Domain Scoring:
Each item is scored using a reverse Likert scale:
- Not at all = 3 points
- A little = 2 points
- Quite a bit = 1 point
- Very much = 0 points

Domain Breakdown:
- Nausea and vomiting – Items 1–4 (max score: 12)
- Eating and drinking – Items 5–9 (max score: 15)
- Fatigue – Items 10–12 (max score: 9)
- Bowel function – Items 13–15 (max score: 9)

Calculation:
Each domain score is calculated by summing the item scores and converting to a percentage:
- Divide by the domain’s maximum score
- Multiply by 100

A score of 100 indicates best possible function; 0 indicates worst. If any item within a domain is missing, that domain score cannot be calculated.

The PRO-diGI was developed in accordance with best practice guidelines from the FDA and COSMIN, following a rigorous four-stage process:

Stage 1 – Item Generation:
Qualitative interviews with 29 patients across five UK hospitals identified 26 subthemes. These informed a draft 44-item questionnaire.

Stage 2 – Face Validity Assessment:
18 patients and 15 clinical experts reviewed the draft. Feedback confirmed high acceptability and relevance, leading to refinements.

Stage 3 – Domain Development and Item Reduction:
297 patients completed the survey. Principal Component Analysis (PCA) refined the questionnaire to 15 items across four domains.

Stage 4 – Reliability and Responsiveness Testing:
- Test–retest reliability: ICC values ≥0.7 across all domains
- Responsiveness: Significant differences in pre- and post-surgery scores
- Known-group validity: Demonstrated ability to distinguish between surgical approaches and recovery outcomes
 

The PRO-diGI has been applied in perioperative trials and observational studies to assess gastrointestinal recovery. It has shown utility in:
- Measuring symptom burden post-surgery
-    Measuring symptom burden after small bowel obstruction
- Comparing outcomes between open and minimally invasive procedures
- Evaluating recovery trajectories and quality of care

Its use has been recommended for studies involving emergency laparotomy, colorectal cancer surgery, and cystectomy.

- Paper and pen completion
- Digital (eCOA) completion available upon request
  - Licensing and review managed by InSpired Health Outcomes (Oxford, UK)
  - Available User Support Documents
- Scoring and administration instructions
- Concept Elaboration Document (to assist with translation and cultural adaptation)

© 2024 Sheffield Teaching Hospitals. All rights reserved.
Licensing is managed by InSpired Health Outcomes, Oxford, UK.
Standard licences are available at no cost for most academic and non-commercial uses. Commercial use may incur fees, determined via the Licence Request Form.