Hamzeh Hayat, Kelly Carol, Lee Annemarie L, Spinou Arietta, Marques Alda, Herrero-Cortina Beatriz, Burtin Chris, Hall Kathleen, Spencer Sally
Faculty of Health, Social Care & Medicine, Edge Hill University, Ormskirk, UK.
Department of Physiotherapy, Monash University, Frankston, 3199, Victoria, Australia.
Heliyon. 2024 Jul 5;10(14):e34101. doi: 10.1016/j.heliyon.2024.e34101. eCollection 2024 Jul 30.
Physiotherapy is recommended for bronchiectasis management, but there is disparity in evidence supporting its use. This is partly because of inconsistency and poor reporting of outcomes in available studies. A Core Outcome Set (COS) may improve trial consistency and decrease reporting bias. This study aimed to develop a COS for physiotherapy clinical trials in adults with bronchiectasis.
A comprehensive list of outcomes was developed using a systematic review and qualitative semi-structured interviews with patients with bronchiectasis and physiotherapists.An international two-round online Delphi survey was conducted. Outcomes scored 7-9 (crucial) by ≥ 70 % of participants and 1-3 (not that important) by ≤ 15 % of participants from each stakeholder in the Likert scale were nominated for inclusion in the COS. Nominated outcomes and those considered crucial by only one of the stakeholders' groups were further discussed and voted in an international consensus meeting.
A list of 137 outcomes was generated; 104 from literature and 33 from interviews. A Delphi survey containing 59 outcomes was completed by 171 participants from 20 countries. After the consensus meeting, representatives agreed on seven outcomes: health-related quality of life, respiratory symptoms, physical functioning, emotional and psychological functioning, fatigue, adherence to treatment, and functional exercise capacity.
A minimum set of seven outcomes are recommended to be included as measurements in future trials evaluating physiotherapy interventions for bronchiectasis.
推荐采用物理治疗来管理支气管扩张症，但支持其使用的证据存在差异。部分原因在于现有研究结果的不一致性和报告不充分。核心结局集（COS）可能会提高试验的一致性并减少报告偏倚。本研究旨在为成人支气管扩张症物理治疗临床试验制定一个核心结局集。
通过系统综述以及对支气管扩张症患者和物理治疗师进行定性半结构化访谈，制定了一份全面的结局清单。开展了两轮国际在线德尔菲调查。在李克特量表中，每个利益相关方中≥70%的参与者评分为7 - 9分（关键）且≤15%的参与者评分为1 - 3分（不太重要）的结局被提名纳入核心结局集。被提名的结局以及仅被其中一个利益相关方群体视为关键的结局在一次国际共识会议上进行了进一步讨论和投票。
生成了一份包含137个结局的清单；104个来自文献，33个来自访谈。来自20个国家的171名参与者完成了一项包含59个结局的德尔菲调查。在共识会议之后，代表们就七个结局达成了一致：健康相关生活质量、呼吸道症状、身体功能、情绪和心理功能、疲劳、治疗依从性以及功能锻炼能力。
建议在未来评估支气管扩张症物理治疗干预措施的试验中，将最少七个结局作为测量指标纳入。
