The RESPECT study: RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology: a study protocol

Abstract

BackgroundSmoking remains a leading health risk factor among Europeans. Tobacco, together with other factors, will lead to an expansive epidemic of chronic diseases, including COPD, among the working population in Russia. The general aim of the RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology (RESPECT) study is to gain a better understanding of the prevalence, pathogenesis and symptoms of COPD.Methods/DesignThe RESPECT study is a prospective, population-based cohort study of subjects aged 35–70 years in two north-west regions of the Russian Federation (Saint Petersburg and Arkhangelsk). The study includes three components: a cross-sectional study (prevalence), a case-control study and a cohort study (diagnostic). An investigator who interviewed the patient completed three questionnaires. Spirometry, including a reversibility test, was offered to all participants. Individuals displaying forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) < 0.7 and/or FEV1/FVC < the lower limit of normal before and/or after bronchodilation were included in a follow-up study and were examined by a pulmonologist using a standardized comprehensive examination protocol. A future case-control study of two matched groups of patients (heavy smokers with COPD versus heavy smokers without COPD) will provide information on which factors (biomarkers, including pneumoproteins, in serum and induced sputum) are related to tobacco-induced COPD.DiscussionIn total, 3133 individuals (2122 from St. Petersburg and 1012 from Arkhangelsk) aged 35–70 years agreed to participate in this study and met the inclusion criteria. In total, 2974 participants met the quality criteria for spirometry, and 2388 reversibility tests were performed. A cohort of newly defined obstructive pulmonary disease patients (247 persons) was established for follow-up investigation.The RESPECT study will provide information regarding the prevalence of COPD in the north-west region of the Russian Federation. Moreover, the comprehensive RESPECT database will enable us to explore new research questions, provide novel insight into the risk factors and different phenotypes of COPD, and contribute to an improved understanding of the reasons why some heavy smokers develop the disease whereas others do not.Clinical trial registrationNCT02307799 (the release date: 12/01/2014)

The Prevalence of Chronic Obstructive Pulmonary Disease by the Global Lung Initiative Equations in North-Western Russia

“…material, see www.karger.com/doi/10.1159/000442887). The RESPECT population includes more women than the average population in the north-west region (68.2 vs. 55.3%; p < 0.05) as well as more participants aged 55-70 years (53.7 vs. 35.3%; p < 0.05) [15]. …”

“…The age and sex distribution in the RESPECT study and in the general population were compared in detail earlier [15]. …”

“…A description of the design and rationale of the RESPECT study has previously been published elsewhere [15]. Briefly, 15 primary care centres in two north-western Russian cities (St. Petersburg and Arkhangelsk) were invited to participate in the RESPECT study, and 15 investigators (10 from St. Petersburg and 5 from Arkhangelsk) were recruited.…”

“…Adults 35-70 years of age were selected from each centre using a random number generator and were subsequently invited to participate in the study. The participating sites agreed to recruit a population-based random sample of at least 200 adults who were not institutionalized, were aged 35-70 years and were living in a well-defined administrative area [15]. The research investigators administered questionnaires regarding the participants' background characteristics, including sociodemographic data, smoking status, occupational exposures and respiratory symptoms.…”

Diagnostic algorithm for detecting chronic obstructive pulmonary disease in primary care

“…Мечникова, Санкт-Петербург (протокол № 11 от 27.11.2011). Подробное описание дизайна проекта опубликовано ра-нее [12]. При проведении анализа учитывали результаты, полученные из базы данных вы-борки жителей Санкт-Петербурга.…”