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

NCT03461497 | Active Not Recruiting

• 1 other identifier: VT 57203
• Study Type: observational
• Target: 530
• Locations: 5 countries
• Sites: 7

Brief Summary

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.

Conditions

Abdominal Surgery

Keywords

Patient-Reported Outcome; Patient Outcome Assessment; Questionnaire; Self-Report; Abdominal Surgery; Postoperative Period; Recovery of Function; Psychometrics; Qualitative Research; Patient-Centered

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcome Measure (PRO)

  PRO measure of recovery after abdominal surgery

  3 years

Study Arms (1)

Patients Cohort

Patients undergoing abdominal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient's that have undergone abdominal surgery

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Hospital São Paulo, Brazil: collaborator
• Hokkaido University Hospital: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Cleveland Clinic Florida: collaborator
• The Cleveland Clinic: collaborator
• Jewish General Hospital: collaborator

Study Sites (7)

Cleveland Clinic Florida

Weston, Florida, United States

Location

Cleveland Clinic (Main Campus)

Cleveland, Ohio, United States

Location

Hospital São Paulo

São Paulo, 04024-002, Brazil

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Canada

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Related Publications (4)

• Fiore JF Jr, Figueiredo S, Balvardi S, Lee L, Nauche B, Landry T, Mayo NE, Feldman LS. How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery. Ann Surg. 2018 Apr;267(4):656-669. doi: 10.1097/SLA.0000000000002415.

  PMID: 28767559 BACKGROUND

• Alam R, Figueiredo SM, Balvardi S, Nauche B, Landry T, Lee L, Mayo NE, Feldman LS, Fiore JF Jr. Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework. Surg Endosc. 2018 Dec;32(12):4874-4885. doi: 10.1007/s00464-018-6242-9. Epub 2018 May 17.

  PMID: 29777351 BACKGROUND

• Alam R, Montanez J, Law S, Lee L, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Feldman LS, Fiore JF Jr. Development of a conceptual framework of recovery after abdominal surgery. Surg Endosc. 2020 Jun;34(6):2665-2674. doi: 10.1007/s00464-019-07044-x. Epub 2019 Aug 1.

  PMID: 31372888 BACKGROUND

• Rajabiyazdi F, Alam R, Pal A, Montanez J, Law S, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Lee L, Feldman LS, Fiore JF Jr. Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery. JAMA Surg. 2021 Aug 1;156(8):758-765. doi: 10.1001/jamasurg.2021.1557.

  PMID: 33978692 BACKGROUND

Study Officials

• Julio F Fiore Jr, PhD

  McGill University, Department of Surgery

  PRINCIPAL INVESTIGATOR

• Liane S Feldman, MD

  McGill University, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 12, 2018
• Study Start: July 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

JP (1); BR (1); IT (1); US (2); CA (2)