Belgian Pulmonary Function Study : the Belgian Thoracic Society
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis.
研究概览
简要总结
Pulmonary function tests including spirometry, lung volumes, measurements of resistance and diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests are an integral part of the diagnosis and treatment of lung diseases, but until now there is no clear evidence for the use of many of the pulmonary function tests because of a lack of adequate studies. The obscurity largely pertains to the conditions under which combinations of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all pulmonologists and the pneumology LOK/GLEM"s, will investigate this matter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Age between 18 and 75 years old
- •New outpatients with respiratory symptoms as dyspnoea, cough, sputum, but without firm diagnosis
- •Results of the tests are available and acceptable
- •Standardized list of complaints
- •Capability of patient for doing pulmonary function tests
- •Seen by a Pneumologist
- •Written informed consent
排除标准
- •Patients with diagnosed respiratory disease
- •Younger than 18 and older than 75 years old
- •Recent heart attack
- •Pneumothorax
- •hemoptoic
- •Suspicion of Tuberculosis
- •Not capable to do pulmonary function tests
结局指标
主要结局
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis.
时间窗: end of study
To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis and its reflection of the gold standard (final diagnosis), a statistical score will be calculated based on 1/n differential diagnoses after every pulmonary function test. The score will contain corrections for a high number of differential diagnoses and a wrong preferential diagnosis and compared with Linear mixed model after logistic transformation.
次要结局
- % correct preferential diagnoses(end of study)
- N differential diagnoses in the subgroup with correct preferential diagnosis(end of study)
- subgroup analyses(end of study)
- Sensitivity analysis(end of study)