SADT in COPD and Oscillometry in Obstructive Airway Disease in Primary Care. The SCOOP-study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The predictive value of SADT-c for detecting SAD in patients with COPD.
研究概览
简要总结
Rationale: The Small Airways are a major site of obstruction in many respiratory diseases, including COPD. More insight into a diagnosis of Small Airways Dysfunction (SAD) in patients with COPD is clinically valuable as it might enable tailored pharmacotherapy. Currently, methods to diagnose SAD in COPD are not standardized and are not available in routine clinical practice. The Small Airways Dysfunction Tool (SADT) was developed to identify patients with asthma and SAD. Initially, the SADT included a comprehensive 63-item questionnaire. The number of items has been reduced to a SADT-asthma (SADT a) questionnaire and key patient and disease characteristics for it to be feasible and implementable in clinical practice. Although there are many similarities between asthma and COPD, there might be differences in clinical characteristics and responses to small airways dysfunction between the two diseases. The current study aims to adapt the original 63-item SADT questionnaire for dedicated use in COPD by reducing the number of items, and identifying COPD-SAD-specific items, to enhance its efficiency in identifying SAD when combined with key patient and disease characteristics in individuals with COPD (SADT-c). In addition, a comparison of diagnostic accuracy of spirometry and oscillometry will be made by interpretations by a panel of experts to provide a triage diagnosis. The previously developed machine learning AC/DC tool will be used to explore its diagnostic accuracy using oscillometry and spirometry results. This can contribute to standardizing oscillometry in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected of having COPD, asthma or ACO as indicated by the referring GP OR a previous diagnosis of COPD
排除标准
- •Inability to understand and sign the written informed consent form.
研究组 & 干预措施
Participants with Small Airway Disease
干预措施: Oscillometer ALDS (Diagnostic Test)
Participants without Small Airway Disease
干预措施: Oscillometer ALDS (Diagnostic Test)
结局指标
主要结局
The predictive value of SADT-c for detecting SAD in patients with COPD.
时间窗: At baseline study visit, during pulmonary function testing
To determine whether SADT-c can be used in patients with COPD to detect SAD.
次要结局
- To determine whether oscillometry and spirometry are equally effective for triage diagnosis in patients in primary care with respiratory symptoms.(At baseline study visit, during initial diagnostic assessment in primary care)
- Assess the diagnostic performance of the Asthma/COPD Differentiation Classification (AC/DC) Tool.(At baseline study visit, with expert panel diagnosis based on data collected during the study assessment)
- Predictive value of SADT-a bronze model for SAD in COPD.(At baseline study visit, during pulmonary function testing)
- Develop SADT-c.(At baseline study visit, using data collected during pulmonary function testing and clinical assessment)
- To evaluate how SADT-c compares to SADT-a.(At baseline study visit, during pulmonary function testing)