A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The aim of the RESPECT study is to gain a better understanding of the prevalence,
      pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study
      seeks to address the following specific objectives/research questions: 1) to estimate the
      prevalence of airflow limitation (AL) and COPD in adults 35-70 years of age in St.Petersburg
      and Arkhangelsk based on sex, age, environmental conditions, socioeconomic status and smoking
      status; 2) to compare the prevalence of COPD in the study population based on the Global
      Strategy for Diagnosis, Management and Prevention of COPD (GOLD) and lower limit of normal
      (LLN) criteria; 3) to identify the diagnostic value of various signs, symptoms and background
      characteristics for the diagnosis of COPD; 4) to determine whether differences in background
      characteristics and inflammatory biomarkers are evident between smokers with and without
      COPD; and 5) to describe co-morbidity, functionality and global health status in a cohort of
      newly diagnosed COPD patients.
    

Detailed description: 
      Two northwestern of Russian Federation (RF) cities (St.Petersburg and Arkhangelsk) were
      selected for the RESPECT study. Fifteen primary care centers were invited to participate in
      this study.

      Fifteen investigators (10 from St.Petersburg and 5 from Arkhangelsk) were recruited
      (predominantly doctors and two highly educated nurses). All investigators received study
      information, including a detailed study protocol and recent guidelines on COPD, and
      participated in a three-week course on spirometry and the clinical diagnosis and management
      of obstructive lung diseases. The sample size was calculated based on two goals: 1) to
      determine a reliable estimate of the prevalence of COPD and 2) to estimate the diagnostic
      value of symptoms with an acceptable confidence interval.

      The sample size for the RESPECT study was estimated using 2828 subjects (based on an 8%
      prevalence of COPD in RF). Assuming an anticipated refusal rate of 20%, 3500 participants
      from St.Petersburg and 1500 from Arkhangelsk were invited to participate in this study.

      The analyses will include cross-sectional and prospective approaches. Prospective analyses
      will be performed on the entire cohort.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First component: The study population was randomly selected from the lists of the 15
        participating centers (these patient lists are organized based on territories).

        Second component (cohort study): All newly identified individuals with airflow limitation
        before and/or after the reversibility test were included in the cohort study.

        Third component: One hundred patients with COPD and a smoking history of more than 10
        pack-years (cases) and one hundred patients with the same smoking history without COPD
        (controls) will be included in the third study.
      
Keywords: tobacco; spirometry; cohort study; case-control study; prevalence