Faculty of Health, Social Care & Medicine, Edge Hill University, Ormskirk, United Kingdom.
Respiratory Research Centre, Edge Hill University, Ormskirk, Lancashire, United Kingdom.
PLoS One. 2022 Feb 8;17(2):e0263695. doi: 10.1371/journal.pone.0263695. eCollection 2022.
Bronchiectasis is a chronic respiratory disease characterised by airways widening and recurrent infections, resulting in episodes of chronic cough, sputum expectoration, and dyspnoea. This leads to deterioration in daily function, repeated hospital admissions and poor quality of life. The prevalence and mortality related to bronchiectasis is increasing worldwide with growing economic burden on healthcare systems. Physiotherapy for bronchiectasis aims to decrease accumulation of sputum, dyspnoea, and improve exercise capacity and daily function. A robust evidence base to support physiotherapy in bronchiectasis is currently lacking. This is partly because of inconsistency and poor reporting of outcomes in available studies. A core outcome set is the minimum acceptable group of outcomes that should be used in clinical trials for a specific condition. This decreases research waste by improving consistency and reporting of key outcomes and facilitates the synthesis of study outcomes in systematic reviews and guidelines. The aim of the study is therefore to develop a core outcome set and outcome measurement set for physiotherapy research in adults with bronchiectasis. This will ensure outcomes important to key stakeholders are consistently used and reported in future research.
This project will use the COMET Initiative and COSMIN guidelines of core outcome set development and will include three phases. In the first phase, a comprehensive list of outcomes will be developed using systematic review of reported outcomes and qualitative interviews with patients and physiotherapists. Then consensus on key outcomes will be established in phase two using a Delphi survey and a consensus meeting. Finally, in phase three, we will identify appropriate instruments to measure the core outcomes by evaluating the psychometric properties of available instruments and a stakeholders' meeting to establish consensus.
The study was reviewed and has received ethical approval from the health-related Research Ethics Committee- Edge Hill University (ETH2021-0217).
This study is registered with the COMET database. https://www.comet-initiative.org/Studies/Details/1931. The full systematic review protocol is registered in PROSPERO under the number CRD42021266247.
支气管扩张症是一种以气道扩张和反复感染为特征的慢性呼吸道疾病，导致慢性咳嗽、咳痰和呼吸困难反复发作。这导致日常功能恶化、反复住院和生活质量下降。随着医疗保健系统经济负担的增加，支气管扩张症的患病率和死亡率在全球范围内都在上升。支气管扩张症的物理治疗旨在减少痰液积聚、呼吸困难，并提高运动能力和日常功能。目前，支持支气管扩张症物理治疗的证据基础还不够强大。这部分是由于现有研究中结果的不一致性和报告质量差。核心结局集是应在特定疾病的临床试验中使用的最低可接受的一组结局。这通过提高关键结局的一致性和报告，减少研究浪费，并促进系统评价和指南中研究结果的综合。因此，该研究的目的是为成人支气管扩张症的物理治疗研究制定一个核心结局集和结局测量集。这将确保未来研究中始终使用和报告对主要利益相关者重要的结局。
该项目将使用 COMET 倡议和 COSMIN 核心结局集制定指南，并包括三个阶段。在第一阶段，将使用系统评价报告的结局和对患者和物理治疗师的定性访谈来制定全面的结局清单。然后，在第二阶段，通过德尔菲调查和共识会议，就关键结局达成共识。最后，在第三阶段，我们将通过评估现有工具的心理测量学特性和利益相关者会议来确定合适的工具来测量核心结局，以确定核心结局。
该研究已通过与健康相关的伦理委员会-埃奇希尔大学进行审查并获得批准（ETH2021-0217）。
该研究在 COMET 数据库中注册。https://www.comet-initiative.org/Studies/Details/1931。完整的系统评价方案在 PROSPERO 中注册，编号为 CRD42021266247。
