Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery

April 9, 2025 updated by: Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre

Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients

As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery.

The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases:

Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items.

Phase 2: Use of Rasch Analysis for item-reduction and scale formation.

Phase 3: Further assessment of measurement properties based on traditional psychometric methods.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

OBJECTIVE:

To develop a comprehensive, conceptually relevant and psychometrically sound PRO measure to assess recovery after abdominal surgery.

OUTLINE:

  • Phase 1(Conceptual framework and item generation): Semi-structured interviews focusing on patient lived experiences after abdominal surgery will be conducted to derive the "final conceptual framework of recovery after abdominal surgery". The interviews are guided by the "hypothesized conceptual framework" which is based on previous literature and expert input. This phase has a minimal targeted sample of 30 patients. To account for potential cross-cultural differences in recovery experiences, the study is enrolling patients from 4 international sites: McGill University Health Centre (Montreal, Canada), Hospital Sao Paulo (Sao Paulo, Brazil), Vita-Salute San Raffaele Hospital (Milan, Italy), and Hokkaido University Hospital (Sapporo, Japan). Interview audio recordings are transcribed, translated if required, and coded according to ICF (International Classification of Functioning, Disability and Health) domains. Codes for which saturation is reached will comprise the final conceptual framework of recovery. Items reflecting the essence of each domain will be generated and patient understanding of the items will be assessed through cognitive interviews. Items for which no problems have been identified and those successfully revised will be compiled into an item pool to be 'calibrated' in subsequent stages of PRO development.
  • Phase 2 (Item selection and scoring- Rasch Analysis): In phase 2, the preliminary item pool generated in phase 1 will undergo refinement using Rasch Measurement Theory (RMT). Based on this analysis, items will be modified or eliminated to ensure that the novel PRO measure fits a linear continuum and produces meaningful scores. A target sample of 100 patients undergoing abdominal surgery will be recruited from three tertiary hospitals in Canada. The participants will complete the preliminary PRO measure at five time points: preoperatively, and on postoperative days (PODs) 1, 7, 30, and 90. Items that fail to fit the Rasch model will be revised or removed.
  • Phase 3 (Validation using traditional psychometric methods): Further evaluation of the measurement properties of the novel PRO measure will be conducted using traditional psychometric methods. A total of 600 patients undergoing abdominal surgery will be recruited in five tertiary hospitals in Canada and in the United States. Participants will complete the PRO measure in different timepoints: preoperatively, and on PODs 1-7, 28, 60, and 90. Assessment of psychometric properties will focus on internal consistency, test-retest reliability, measurement error, hypothesis testing construct validity, responsiveness, and criterion validity. Interpretability will be assessed by estimating the minimal important difference (MID) using anchor-based methods.

Study Type

Observational

Enrollment (Estimated)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04024-002
        • Hospital São Paulo
  • Canada
      • Montreal, Canada
        • Jewish General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • Italy
      • Milano, Italy, 20132
        • San Raffaele Hospital
  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
  • United States
    • Florida
      • Weston, Florida, United States
        • Cleveland Clinic Florida
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic (Main Campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patient's that have undergone abdominal surgery

Description

The following applies to all phases of the project.

Inclusion Criteria:

  • Age ≥18 years old
  • Abdominal surgery within three days to three months before enrolment
  • Fluent in the local language
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Documented mental impairment
  • Palliative care
  • Advanced musculoskeletal, neurological, pulmonary or cardiac disorders
  • Organ transplantation
  • Cesarean section

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients Cohort
Patients undergoing abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome Measure (PRO)
Time Frame: 3 years
PRO measure of recovery after abdominal surgery
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

The Cleveland Clinic
Jewish General Hospital
Cleveland Clinic Florida
Hokkaido University Hospital
San Raffaele University Hospital, Italy
Hospital São Paulo, Brazil

Investigators

  • Principal Investigator: Julio F Fiore Jr, PhD, McGill University, Department of Surgery
  • Principal Investigator: Liane S Feldman, MD, McGill University, Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VT 57203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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