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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Lung Cancer | Study protocol

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

Authors: Wanjun Zhou, Yawen Zhang, Zhiwei Wang, Liang Zhang, Xinqiong Zhang

Published in: Trials | Issue 1/2024

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Abstract

Background

Outcome assessment in perioperative exercise trials for lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This heterogeneity hinders the synthesis of evidence. To address this issue, a core outcome set, an agreed-upon standardized set of outcomes to be measured and reported, is required to reduce heterogeneity among outcome measurements. 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 is divided into four steps. Stage I: Conducting a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains. Stage II: Conducting semi-structured interviews to obtain important outcomes for patients. Stage III: Choosing the most important outcomes by conducting two rounds of the Delphi exercise. Stage IV: Achieving a 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 perioperative exercise trials in lung cancer, which will enhance the quality, comparability, and usability of future trials and positively impact 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
Appendix
Available only for authorised users
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Metadata
Title
Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients
Authors
Wanjun Zhou
Yawen Zhang
Zhiwei Wang
Liang Zhang
Xinqiong Zhang
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-07985-2

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