Respiratory Sciences, University of Leicester, Leicester, UK.
Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.
BMJ Open. 2021 Nov 23;11(11):e057362. doi: 10.1136/bmjopen-2021-057362.
Chronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.
Ten general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is 'usual care' and the study experience.
The Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.
ISRCTN14483247.
慢性呼吸困难是一种常见且使人虚弱的症状，与高医疗保健使用率和降低的生活质量相关。患有慢性呼吸困难的人经常面临诊断方面的挑战和延误，导致治疗延迟。主要假设是，在初级保健中采用基于症状的诊断方法将导致更早的诊断，从而更早地治疗，并改善长期结果，包括与健康相关的生活质量。本研究旨在建立一项多中心集群随机对照试验，以评估初级保健中呼吸困难的结构化诊断途径的临床和成本效益。
莱斯特和莱斯特郡的 10 家全科医生 (GP) 实践将被集群随机分配到结构化诊断途径（干预）或常规护理。结构化诊断途径包括在 1 个月内进行一系列检查。常规护理将按照正常的患者护理进行。入选标准包括首次出现慢性呼吸困难的患者，年龄超过 40 岁且无现有症状诊断。在与全科医生的咨询点触发电子模板将有助于在初级保健中进行机会性招募。本可行性研究的主要结果是招募率。次要结果指标，包括诊断时间，将被收集，以帮助为未来的试验提供结果并评估早期诊断的影响。这些将包括症状、与健康相关的生活质量、运动能力、虚弱指标、身体活动和医疗保健利用。该研究将包括对患者和医疗保健人员的嵌套定性访谈，以了解可行性结果，探讨什么是“常规护理”以及研究体验。
诺丁汉 1 研究伦理委员会已为本研究提供伦理批准（REC 参考：19/EM/0201）。研究结果将通过在相关会议和会议上的演讲进行传播，包括英国胸科学会和初级保健呼吸学会，以及通过同行评议的出版物，并通过向患者提供演讲和通讯，如果可行的话。
ISRCTN82310442。
