Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Abstract

Abstract Background Outcome assessment in perioperative exercise trials of lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This hinders evidence synthesis. To solve this problem, a core outcome set, an agreed standardized set of outcomes to be measured and reported to reduce heterogeneity among outcome measures, is needed. This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice. Methods The project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, Which will be divided into four steps. Stage Ⅰ: Conduct a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains.. Stage Ⅱ: Conduct semi-structured interviews to obtain important outcomes for patients. Stage Ⅲ: Choose the most important outcomes by conducting two-round Delphi surveys. Stage Ⅳ: Establish consensus in a face-to-face meeting to discuss the final core outcome set. Discussion This is the first project identified for the core outcome set of outcomes for perioperative exercise trials for lung cancer, which will improve the quality, comparability, and usability of future trials and positively impact the perioperative exercise and the care of patients with lung cancer. Trials registration Core Outcome Measurement in effectiveness Trials (COMET) Initiative database registration: https://www.comet-initiative.org/Studies/Details/2091