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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Patient-Reported Outcome Measure (PRO) — 3 years
  PRO measure of recovery after abdominal surgery

Trial sites (7)

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada