Registry of COPD Patients Who Undergo Outpatient Treatment or Are Under Surveillance at Outpatient Polyclinic Healthcare Institutions of the Russian Federation in Moscow
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).
研究概览
简要总结
To describe the clinical profile of COPD patient who is under outpatient surveillance at polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade, distribution by disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).
详细描述
The registry of COPD patients in fact represents non-interventional multicenter retrospective study including all COPD patients included into the registry retrospectively from patients medical records and newly diagnosed under outpatient surveillance at the selected polyclinic institutions of Moscow.
The registry will include all patients with registered diagnoses J40 - J44 according to ICD-10 with spirometry results confirming COPD diagnosis, who are at the study start under outpatient surveillance, and also newly registered patients diagnosed with COPD (ICD-10 J40 - J44, as confirmed by spirometry results) during the conduction of the registry program at the selected polyclinic institutions of Moscow (according to ICD: J40 - Bronchitis, not specified as acute or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple chronic bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - Unspecified chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive pulmonary disease) based on regular (yearly) retrospective analysis of patient records with data entry into a consolidated database.
It is planned to enrol into the study approximately 2000 male and female patients over 40 years of age with diagnosed COPD (as confirmed by spirometry results).
The present observational multicenter descriptive study will be conducted in the setting of routine clinical practice of outpatient polyclinic institutions. There is no hypothesis to be tested in this study.
The study will be conducted in outpatient polyclinic institutions of the primary medical care system of Moscow. Pulmonologists of the primary medical care system will be engaged as investigators. These are the physicians, whom the patients with tentative COPD diagnosis are referred to in the Russian Federation and who within the scope of their responsibilities have access to source medical records and who evaluate the quality of diagnosis and extent of treatment prescribed to COPD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smokers or ex-smokers, with previously diagnosed COPD
- •COPD diagnosis corresponding to ICD codes J40 - J44 (J40 - Bronchitis, not specified as acute or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple chronic bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - Unspecified chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive pulmonary disease
- •COPD diagnosis confirmed by spirometry results (spirometry is performed as normal with bronchodilator testing using salbutamol 400 µg, post-BD FEV1\ FVC < 0.7)
排除标准
- •Tuberculosis
- •Sarcoidosis
结局指标
主要结局
COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).
时间窗: 1 day
COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).
To describe the clinical profile of COPD patient in Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade
时间窗: 1 day
To describe the clinical profile of COPD patient who is under outpatient surveillance at polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade, distribution by disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).
次要结局
- Mean number of hospitalizations in the last year in COPD patients(1 year)
- Mean number of exacerbations requiring medical attention (outpatient prescription of oral corticosteroids and/or antibiotics) in the last year in COPD patients(1 year)
- Disease burden based on the collected data concerning the duration of temporary disability(1 year)
- Disease burden based on the collected data concerning the outpatient visits due to COPD(1 year)
- To determine the percentage of patients with eosinophilic inflammation according to haematology results(3 years)
- To describe treatment regimens prescribed to COPD patients depending on disease severity grade in the setting of real-life clinical practice(3 years)
- To establish the percentage of medical prescriptions for treatment of COPD patients which comply with current Federal clinical guidelines for diagnosis and treatment of chronic obstructive pulmonary disease.(1year)
- To evaluate the disease burden based on the collected data concerning the duration of temporary disability of patients under outpatient surveillance(1 year)
- To evaluate the disease burden based on the collected data concerning the number of hospitalizations due to COPD exacerbations(1 year)
- Percentage of patients with different disease phenotypes among outpatients(1 day)
- Percentage of prescriptions of medicinal products to COPD patients depending on disease severity grade in the setting of real-life clinical practice(1 year)
- Distribution (%) of COPD patients who seek attention from primary medical care physicians by severity of airway obstruction(1 year)