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

Running, not enrolling

Conditions studied: Abdominal Surgery

In brief

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.

Key facts

Study ID

NCT03461497

Run by

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

People needed

530

Starts

2016-07-01

Expected to finish

2026-07-01

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States
• Cleveland Clinic (Main Campus) — Cleveland, Ohio, United States
• Hospital São Paulo — São Paulo, Brazil
• Montreal General Hospital — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Canada
• San Raffaele Hospital — Milan, Italy
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.