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肺癌患者康复结局研究(UNITE):核心结局集制定方案。

Rehabilitation outcomes for people with lung cancer (UNITE): protocol for the development of a core outcome set.

机构信息

Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia

Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

出版信息

BMJ Open Respir Res. 2023 Jun;10(1). doi: 10.1136/bmjresp-2022-001571.

DOI:10.1136/bmjresp-2022-001571
PMID:37336620
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10347493/
Abstract

INTRODUCTION

With treatment-related improvements in survival, rehabilitation is essential to improve function and health-related quality of life and manage the high symptom burden associated with lung cancer. Despite this, significant heterogeneity exists in the outcomes and instruments used to evaluate lung cancer rehabilitation programme impact. This study aims to develop a core set of clinically relevant lung cancer rehabilitation outcomes for use in clinical practice.

METHODS AND ANALYSIS

An international Delphi consensus study involving consumer, healthcare professional and researcher stakeholders to determine which outcomes to include and how to measure these. Stage 1 (preliminary): mixed methods to develop the potential list of outcomes (1) overview of systematic reviews of lung cancer exercise interventions and (2) focus groups and individual interviews with people with lung cancer. Stage 2: outcomes were grouped according to the International Classification of Functioning, Disability and Health domains. Stage 3: to determine priority outcomes for core outcome set (COS) inclusion participants will rate each outcome's importance (one-nine-point Likert scale) over two-three survey rounds. Stage 4: following review by the steering committee, a consensus meeting will be held if agreement on the COS has not been reached.Stage 5: recommendations will be made regarding a single instrument for measuring each COS outcome by reviewing existing resources where consensus has already been reached. Where resources do not exist the quality and feasibility of potential measurement instruments will be appraised, and the Delphi consensus survey and meeting process outlined in stages 3-4 will be repeated.This protocol adheres to the COS-Standardised Protocol statement and will be conducted and reported according to the COS-Standards for Development recommendations and the COS-Standards for Reporting.

ETHICS AND DISSEMINATION

Ethics approval (20/9/22, University of Melbourne ID 2022-24839-32231-3). Dissemination in peer-reviewed journals and conference presentations.

摘要

简介

随着与治疗相关的生存改善,康复对于提高功能和健康相关生活质量以及管理与肺癌相关的高症状负担至关重要。尽管如此,在评估肺癌康复计划影响的结果和使用的工具方面仍然存在显著的异质性。本研究旨在确定一组用于临床实践的肺癌康复的核心临床相关结果。

方法和分析

一项涉及消费者、医疗保健专业人员和研究人员利益相关者的国际 Delphi 共识研究,以确定要纳入的结果以及如何衡量这些结果。第 1 阶段(初步阶段):采用混合方法制定潜在的结果清单(1)对肺癌运动干预的系统评价综述,(2)对肺癌患者的焦点小组和个人访谈。第 2 阶段:根据国际功能、残疾和健康分类对结果进行分组。第 3 阶段:为确定核心结果集(COS)纳入的优先结果,参与者将在两轮三回合的调查中对每个结果的重要性(1-9 点 Likert 量表)进行评分。第 4 阶段:如果未就 COS 达成一致意见,将由指导委员会进行审查,并举行共识会议。第 5 阶段:如果已经达成共识,则将通过审查现有的资源提出用于测量每个 COS 结果的单一工具的建议,这些资源已经达成共识。如果没有资源,则将评估潜在测量工具的质量和可行性,并重复第 3-4 阶段中的 Delphi 共识调查和会议过程。本方案遵循 COS 标准化方案声明,并将根据 COS 开发建议和 COS 报告标准进行和报告。

伦理与传播

伦理批准(2022 年 9 月 22 日,墨尔本大学 ID 2022-24839-32231-3)。在同行评议的期刊和会议报告中进行传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ada3/10347493/19fe558f06ed/bmjresp-2022-001571f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ada3/10347493/19fe558f06ed/bmjresp-2022-001571f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ada3/10347493/19fe558f06ed/bmjresp-2022-001571f01.jpg

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Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews.肺癌全程护理中的运动:系统评价概述
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Preoperative exercise training for people with non-small cell lung cancer.非小细胞肺癌患者的术前运动训练。
Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients.
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What should be measured and reported in clinical trials for the treatment of patients with acute pancreatitis? A study protocol for establishing a core outcome set.在治疗急性胰腺炎患者的临床试验中应测量和报告哪些内容?建立核心结局集的研究方案。
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