腹部手術後の回復を評価するための患者報告アウトカム尺度の開発

基本情報

NCT ID

NCT03461497

ステータス

実施中（募集終了）

試験のフェーズ

-

試験タイプ

観察

目標被験者数

530

治験依頼者名

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

概要

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.

対象疾患

依頼者（Sponsor）

実施施設 (1)