Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
Public ClinicalTrials.gov record NCT03461497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03461497
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Other
- Enrollment
- 530 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2016
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
- Last update posted
- Apr 12, 2025
2016 – 2026
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | — | — |
| Cleveland Clinic (Main Campus) | Cleveland | Ohio | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03461497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03461497 live on ClinicalTrials.gov.