Научная статья на тему 'Objectives and design of Russian registry of hypertension, coronary artery disease, and chronic heart failure'

Objectives and design of Russian registry of hypertension, coronary artery disease, and chronic heart failure Текст научной статьи по специальности «Клиническая медицина»

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Russian Open Medical Journal
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HYPERTENSION / CORONARY ARTERY DISEASE / CHRONIC HEART FAILURE / REGISTRУ / QUALITY CONTROL / CLINICAL INDICATORS

Аннотация научной статьи по клинической медицине, автор научной работы — Gridnev Vladimir I., Kiselev Anton R., Posnenkova Olga M., Popova Yulia V., Lazareva Natalya V.

Introduction Among the causes of mortality in Russia, as in most developed countries, the first position is occupied by the cardiovascular diseases (CVD). It may be caused by different reasons, including an insufficient quality of healthcare. Methods The Russian Registry of Hypertension, Coronary Artery Disease, and Chronic Heart Failure (RusR-Htn-CAD-CHF) is a retrospective, continuous, nationwide, web-based registry of patients with the following chronic CVD: hypertension (Htn), coronary artery disease (CAD) and chronic heart failure (CHF). Participation in the RusR-Htn-CAD-CHF is voluntary. Any health facilities that provide primary healthcare to patients with one or several of the evaluated chronic CVD (Htn, CAD, and CHF) can take part in the RusR-Htn-CAD-CHF. The RusR-Htn-CAD-CHF enrolls patients who underwent care in Russian health facilities from January 2013 to the present day. Key data elements and methods of data analysis in the RusR-Htn-CAD-CHF are presented in this paper. Results Up to 2016, 69 healthcare units (from small rural clinics to large regional dispensaries) from 18 regions of Russia participated in the RusR-Htn-CAD-CHF. Currently, the database contains data on more than 41,000 patients with one or several chronic CVD (Htn, CAD, and CHF) who were followed-up from 2013 to current day. However, the contribution of regions to data collection of the RusR-Htn-CAD-CHF is nonuniform. In database, the major part of participants (88.7%) is from the Ivanovo region. Current statement of promotion of RusR-Htn-CAD-CHF, some problems, and first advances are considered in the present paper. Conclusion The RusR-Htn-CAD-CHF is a novel project for the Russian healthcare. It has good prospects for the assessment of healthcare quality in Russian patients with Htn, CAD, and CHF.

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Текст научной работы на тему «Objectives and design of Russian registry of hypertension, coronary artery disease, and chronic heart failure»

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Trial design

Objectives and design of Russian Registry of Hypertension, Coronary Artery Disease, and Chronic

Heart Failure

Vladimir I. Gridnev 1, Anton R. Kiselev 1, Olga M. Posnenkova 1, Yulia V. Popova 1, Natalya V. Lazareva 2, Olga A. Belova 3, Svetlana V. Romanchuk 4, Mikhail D. Prokhorov 5, Pavel Ya. Dovgalevsky 1, Elena V. Oshchepkova 2

1 Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia

2 Russian Cardiology Research and Production Complex, Moscow, Russia

3 Ivanovo Regional Cardiology Dispensary, Ivanovo, Russia 4 Healthcare Department of Ivanovo Region, Ivanovo, Russia 5 Saratov Branch of the Institute of Radio Engineering and Electronics of Russian Academy of Sciences, Saratov, Russia

Received 10 March 2017, Revised 12 April 2017, Accepted 25 April 2017

© 2017, Gridnev V.I., Kiselev A.R., Posnenkova O.M., Popova Yu.V., Lazareva N.V., Belova O.A., Romanchuk S.V., Prokhorov M.D., Dovgalevsky P.Ya., Oshchepkova E.V.

© 2017, Russian Open Medical Journal

Abstract: Introduction — Among the causes of mortality in Russia, as in most developed countries, the first position is occupied by the cardiovascular diseases (CVD). It may be caused by different reasons, including an insufficient quality of healthcare.

Methods — The Russian Registry of Hypertension, Coronary Artery Disease, and Chronic Heart Failure (RusR-Htn-CAD-CHF) is a retrospective, continuous, nationwide, web-based registry of patients with the following chronic CVD: hypertension (Htn), coronary artery disease (CAD) and chronic heart failure (CHF). Participation in the RusR-Htn-CAD-CHF is voluntary. Any health facilities that provide primary healthcare to patients with one or several of the evaluated chronic CVD (Htn, CAD, and CHF) can take part in the RusR-Htn-CAD-CHF. The RusR-Htn-CAD-CHF enrolls patients who underwent care in Russian health facilities from January 2013 to the present day. Key data elements and methods of data analysis in the RusR-Htn-CAD-CHF are presented in this paper.

Results — Up to 2016, 69 healthcare units (from small rural clinics to large regional dispensaries) from 18 regions of Russia participated in the RusR-Htn-CAD-CHF. Currently, the database contains data on more than 41,000 patients with one or several chronic CVD (Htn, CAD, and CHF) who were followed-up from 2013 to current day. However, the contribution of regions to data collection of the RusR-Htn-CAD-CHF is nonuniform. In database, the major part of participants (88.7%) is from the Ivanovo region. Current statement of promotion of RusR-Htn-CAD-CHF, some problems, and first advances are considered in the present paper.

Conclusion — The RusR-Htn-CAD-CHF is a novel project for the Russian healthcare. It has good prospects for the assessment of healthcare quality in Russian patients with Htn, CAD, and CHF.

Keywords: hypertension, coronary artery disease, chronic heart failure, registry, quality control, clinical indicators.

Cite as Gridnev VI, Kiselev AR, Posnenkova OM, Popova YuV, Lazareva NV, Belova OA, Romanchuk SV, Prokhorov MD, Dovgalevsky PYa, Oshchepkova EV. Objectives and design of Russian Registry of Hypertension, Coronary Artery Disease, and Chronic Heart Failure. Russian Open Medical Journal 2017; 6: e0201.

Correspondence to Vladimir I. Gridnev. Address: Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, 112, Bolshaya Kazachya str., Saratov, 410012, Russia. Email: [email protected].

Introduction

Among the causes of mortality in Russia, as in most developed countries, the first position is occupied by the cardiovascular diseases (CVD) [1]. CVD have caused 50.1% cases of total mortality in 2014 in Russia [1]. In some countries with a comparable economic level, the mortality rate is lower and life expectancy is higher than that in Russia [2]. It may be caused by different reasons, including an insufficient quality of healthcare.

In various countries, there are a number of registries that include patients with main chronic CVD, such as hypertension (Htn) [3-12], coronary artery disease (CAD) [9, 13-18], and chronic

heart failure (CHF) [15, 16, 19-23]. The main goal of registries is to fill the gap between probative data of randomized controlled trials and real clinical practice [24]. The registries can also be the basis for epidemiologic studies, original studies, risk modeling, etc.

The registry is an ideal tool for studying the real clinical practice, especially when it is necessary to improve the quality of healthcare [25]. Registries of CVD can be useful for increasing the management efficiency in the healthcare system [25]. The problem of improving the quality control methods of providing healthcare to patients is very relevant [8, 26, 27], including for Russia [28]. In real practice, the use of existing Russian healthcare standards is often accompanied by various difficulties, for

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

example, inadequate management and funding of healthcare, low patients' compliance, and lack of qualified specialists, necessary equipment, and drugs [28-30].

The first Russian registry of Htn was created in 2006 and has been used successfully up to 2012 inclusive. The main results of this registry were published in Russian scientific journals [31-35]. In 2012, the novel registry, named the Russian Registry of Hypertension, Coronary Artery Disease, and Chronic Heart Failure (RusR-Htn-CAD-CHF), was created, which replaced the first registry of Htn. The goal of the novel registry was to collect information about the patients with one or several of the following chronic CVD: Htn, CAD, and CHF.

The aim of this paper is to describe the objectives and design of the RusR-Htn-CAD-CHF. Presented results may be interesting to a wide audience because the RusR-Htn-CAD-CHF is currently the largest registry of Russian patients with Htn, CAD, and CHF.

Description of RusR-Htn-CAD-CHF

Objectives

The main objectives of RusR-Htn-CAD-CHF are the following:

i) to create the Russian national database containing information on healthcare delivered to patients with Htn and/or CAD and/or CHF in primary care and specialized healthcare;

ii) to obtain the data on the demographic, clinical, and laboratorial characteristics of patients with Htn and/or CAD and/or CHF in the Russian healthcare;

iii) to identify the national features of associations between the characteristics of evaluated chronic CVD (Htn, CAD, and CHF) and clinical outcomes, including quality of primary care and specialized healthcare;

iv) to propose a practical guide for improving the quality and efficiency of healthcare in each health facilities participating in the RusR-Htn-CAD-CHF.

Developers

The Russian Cardiology Research and Production Complex (Moscow, Russia) was responsible for the development of the RusR-Htn-CAD-CHF and centralized the data analysis at a federal level. The RusR-Htn-CAD-CHF was established in 2011-2012 by researchers, cardiologists, and IT specialists from the Saratov Research Institute of Cardiology (Saratov, Russia). The current support of the RusR-Htn-CAD-CHF is carried out by the staff of both the above-mentioned organizations.

Participation

Participation in the RusR-Htn-CAD-CHF is voluntary and free of charge. Any health facility that provides primary care for patients with Htn, CAD, and CHF can participate in the Registry by sending a request to the technical support staff. Starting from 2013, many health facilities from different regions of Russia were invited to take part in the RusR-Htn-CAD-CHF by the Russian Cardiology Research and Production Complex (Moscow, Russia). Up to 2016, 69 healthcare units (from small rural polyclinics to large regional dispensaries) from 18 regions of Russia participated in the RusR-Htn-CAD-CHF. However, the contribution of regions to data collection of the RusR-Htn-CAD-CHF is nonuniform. The major part of participants of the RusR-Htn-CAD-CHF is from the Ivanovo

region. Ivanovo region is a main participant which is now owned by a majority of patient data in database. Ivanovo region is a region in the Central Federal District of Russia. According to official data of Federal State Statistics Service of Russian Federation (http://www.gks.ru), the population of Ivanovo region was 1,036,900 people (44.9% male) in January 2015. It is 2.7% of population of the Central Federal District of Russia, and 0.7% of total Russian population (http://www.gks.ru). The main demographic characteristics of Ivanovo region are the following: the proportion of adult people is 84.4% (vs 82.4% in all-Russia), mean age of inhabitants is 41.5 years (vs 39.5 years in all-Russia), the proportion of urban people is 81.2% (vs 74.0% in all-Russia), and cardiovascular mortality among total population is 0.64% (vs 0.65% in all-Russia).

Now, 4.2% (36,424 people) of adult population (875,513 people) of Ivanovo region are registered in the RusR-Htn-CAD-CHF. In other regions of Russia, the using of RusR-Htn-CAD-CHF is only at the beginning.

Design of RusR-Htn-CAD-CHF

The RusR-Htn-CAD-CHF is a retrospective, continuous, nationwide, web-based registry operating online (URL: http://62.117.81.44/Register/login.aspx). The design of RusR-Htn-CAD-CHF is based on the national and international clinical guidelines on diagnostics and treatment of Htn, CAD, and CHF [3642].

Access to the Registry is given to registered members. Each user has a unique identification number and password to log into the database. The web forms are designed to be interactive. They limit or exclude certain options in order to avoid the entry of conflicting or spurious data. Wherever possible, the data are entered by selection from "drop-down" lists in order to minimize the number of keyboard errors. The purpose of all the above-mentioned measures is to maximize the accuracy of data.

he web interface of RusR-Htn-CAD-CHF contains 9 web forms with the following titles:

i) Personal data of patients;

ii) Past history;

iii) Results of physical examination at visit;

iv) Results of instrumental examinations;

v) Results of laboratory tests;

vi) Non-pharmacologic treatment;

vii) Drug treatment;

viii) Invasive treatment;

ix) Diagnosis and its codes according to the International Classification of Diseases 10 (ICD-10).

Each web form can be saved unlimited number of times with different dates that allows accumulating the information about the dynamics of clinical parameters of patients over time.

Patients

The RusR-Htn-CAD-CHF enrolls patients with Htn and/or CAD and/or CHF receiving primary healthcare in Russia. The enrollment of patients started in January 2013 and is continued up to the present day.

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2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Inclusion criteria comprise established diagnosis of Htn and/or CAD and/or CHF in patients' medical card, and age >18 years. The RusR-Htn-CAD-CHF has no any exclusion criteria.

Data elements

The key data elements and definitions of RusR-Htn-CAD-CHF database were developed using ACCF/AHA 2011 Key Data Elements and Definitions of the Base Cardiovascular Vocabulary for Electronic Health Records [43] and national and international clinical guidelines on diagnostics and treatment of Htn, CAD, and CHF [36-42].

Data on patients' demographics, clinical characteristics, non-pharmacologic and drug treatment, and invasive intervention are collected. The key data elements of RusR-Htn-CAD-CHF database are presented in Appendix A. The list of data elements recommended to filling depends on the diagnosis (Htn, CAD, or CHF) (see Appendix A).

For each included patient, the web form (see Design of RusR-Htn-CAD-CHF) can be saved multiple times with different dates signed by user according to the dates in patients' medical card.

Data collection

The health facilities participating in the RusR-Htn-CAD-CHF were asked to include all patients following inclusion criteria treated for Htn, CAD, and CHF. For each included patient, new data may be added to the database annually in the case of necessity. Thus, the RusR-Htn-CAD-CHF can be used not only for the retrospective study, but also for the prospective evaluation (observation). Several health facilities can enter data on the same patient, if they provided him medical care at the same time or sequentially. The source of patients' data is the patient medical card and/or the hospital chart. The design of RusR-Htn-CAD-CHF does not allow to study of mortality in patients with chronic CVD.

In each center, one or several physicians were trained to log the data of patients into the Registry. To help these physicians, a detailed user manual was developed [44]. This user manual is available on the RusR-Htn-CAD-CHF website.

Currently, the RusR-Htn-CAD-CHF contains the data on more than 41,000 patients with one or several chronic CVD (Htn, CAD, and CHF) who were followed-up in 2013-2015. As for the proportion of chronic CVD presentations included in the Registry since 2013, we have only an approximate estimation. For example, the main participant (Ivanovo region) owns 36,424 patients in the registry. That is about 4.2% of the total number of adults in this region. In other regions, this proportion is even smaller.

The health facilities are interested in accurate data collection because these data are analyzed further by experts separately for each center and used on site for healthcare quality management.

Data security

Some of the main features of database and web security issues should be mentioned briefly. As it is mentioned above, all users are assigned a unique username/password combination that is used to log on to the RusR-Htn-CAD-CHF. In this way, all transactions are recorded automatically in the web server's log.

All the data are pseudonymously entered into a web-based database protected by a password on a safe server of the Russian Cardiology Research and Production Complex (Moscow, Russia)

using SSL connections. Subject identification is possible only at the local study site and participating centers are exclusively able to review and modify the patient data. The data on patients with chronic CVD can be added to the RusR-Htn-CAD-CHF and can be changed, but cannot be removed. The transmitted data are stored in the central database on the central server at the Russian Cardiology Research and Production Complex (Moscow, Russia).

The purpose of all the above-mentioned measures is to ensure the confidentiality of data.

Ethical aspects

The study protocol including patient information and consent forms has been reviewed and approved by the Ethics Commission of the Russian Cardiology Research and Production Complex (Moscow, Russia).

All patients must give informed consent before inclusion of their personal and clinical data in the RusR-Htn-CAD-CHF. The standard informed consent form is available on the RusR-Htn-CAD-CHF website. Patients gave their informed consent during their first visit to health facilities in the period of inclusion.

Personal data are coded automatically when entered into the registry. Names, addresses and other data which allows identification of a patient do not stored on the central server. Patients' personal data are available only for staff of a healthcare facility where patients are treated.

The appropriate measures are used to guarantee maximal data confidentiality.

Data analysis

Within the RusR-Htn-CAD-CHF, an analytical module was created for the assessment of guidelines implementation in patients with Htn, CAD, and CHF. The main aim of this analytical module is to implement the system analysis of clinical cases to achieve the clinical result (for example, to achieve the target blood pressure in patients with Htn).

In the RusR-Htn-CAD-CHF, the completeness of clinical guidelines performance in real healthcare is evaluated using the developed clinical indicators, which are calculated automatically by using the database query for a required cohort of patients (in primary care facilities, in regions of Russia, or in all-Russia). These indicators were developed on the basis of national and European guidelines using the ACCF/AHA methodology for the development of quality measures for cardiovascular technology [45]. The details of clinical indicators are presented in Appendix C.

Based on the presented clinical indicators, the quality of care in patients with chronic CVD could be compared among Russian healthcare units. This approach allows not only evaluation of the quality of care in a particular unit based on clinical guidelines, but also allows comparative evaluation of health facilities in a city, region or the whole Russia.

Discussion

Registries of diseases allow collecting data from large populations of patients. Currently, the use of RusR-Htn-CAD-CHF is local. Only one region (Ivanovo region) uses the Registry systematically. In other regions of Russia, we have only the first results of RusR-Htn-CAD-CHF using. However, these results can be employed for the evaluation of quality of healthcare in health

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2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

facilities participating in the project [46-50]. The first results of RusR-Htn-CAD-CHF caused debate among some Russian cardiologists. Some authors reported their comments and suggestions to improving this Registry [51]. Heterogeneity of quality and efficiency of secondary prevention of CVD in different regions of Russia (according to 2014 report [47]) shows relevant improvement of healthcare in these regions based on using the RusR-Htn-CAD-CHF [52]. According to S.V. Balashov [52], similar approach can be used also for primary cardiovascular prevention, which is also an urgent problem for the Russian cardiology. There is evidence of the successful use of RusR-Htn-CAD-CHF for healthcare quality control in a certain clinic [53, 54]. The basic principle of clinical indicators of RusR-Htn-CAD-CHF (see Appendix C) is the following: the quality indicator must contribute to the achievement of clinical outcome.

Since the RusR-Htn-CAD-CHF uses key data elements and definitions recommended by the American College of Cardiology and American Heart Association, the results of our study have the potential to be used for cross-country comparison of different registries in other European countries and the USA.

Currently, the data filling of RusR-Htn-CAD-CHF faced some difficulties. The use of RusR-Htn-CAD-CHF in practical healthcare meets the problem of reorganizing the workload of staff in health facilities providing care for patients with chronic CVD. Untrained users may have some difficulties with the use of RusR-Htn-CAD-CHF. To solve this problem we developed a user manual [44].

Due to the first Russian registry of Htn (2006-2012), it became possible to trace for several years the level of implementation of clinical guidelines among Russian patients with Htn. It was found out that the level of guidelines implementation is low, compared to economically developed countries [34, 35, 55, 56]. In 2008, only 22% of hypertensive patients had the goal blood pressure and/or satisfactory quality of healthcare [32]. It has been shown that primary care physicians do not conduct correction of cardiovascular risk factors and diagnosis of lesions of target organs and/or associated clinical conditions, which leads to an underestimation of cardiovascular risk and inadequate choice of treatment tactics in patients with Htn [32, 34]. In 2007, 64% of hypertensive patients had medicinal purposes in medical card [34]. At the same time, assigned antihypertensive therapy is fully consistent with the clinical status in 6.5% of total patients with Htn [34].

One of the reasons of low guidelines implementation is a set of current healthcare indicators powered by the Russian Ministry of Health. These indicators are solely organizational. They are used to calculate the average cost of treatment of a typical patient. These indices are not associated with the clinical objectives of treatment [28]. Such dissonance is a major problem in the transition of the Russian healthcare system to higher quality level. Novel registry (the RusR-Htn-CAD-CHF) will provide an objective view not only on patients with Htn, but also on patients with CAD and CHF. In the future, the RusR-Htn-CAD-CHF may provide the basis for implementing local initiatives, such as "pay for performance". Similar projects were implemented in the US and UK [57-59].

In recent years, the attention to primary and secondary prevention of chronic CVD significantly increased in Russia and other countries [60-64]. Some authors have shown that coronary revascularization was often performed unnecessarily from the clinical point of view [65]. It is known that Russian patients with CAD are characterized by more severe clinical status compared

with the same patients from other economically developed countries [66, 67]. However, the percitaneous coronary intervention (PCI) is carried out less frequently in these patients in Russia [66-68]. Soon, criteria of assessment of needs and appropriateness of coronary revascularization [69] will be added to analytical apparatus of the RusR-Htn-CAD-CHF. It is important for modern healthcare in Russia, taking into account the lack of probative data on the necessity and appropriateness of using the coronary revascularization in CAD patients in Russia. Our systematic search in database of Russian Science Citation Index gave no results.

The RusR-Htn-CAD-CHF may be also used as a basis for improving the quality of primary and secondary prevention of chronic CVD. Some Russian health facilities are already using the RusR-Htn-CAD-CHF for the assessment of quality of cardiovascular primary prevention [53].

In Russia, there are other registries of patients with Htn (RECVASA registry, local registries in Tomsk region, Tyumen region, and some other regions) [70-72], CAD (PROGNOS CHD registry and RECVASA registry) [73, 74], and CHF (RIF-CHF registry and Russian Hospital Chronic Heart Failure Registry) [75, 76]. But the RusR-Htn-CAD-CHF is currently the largest registry of Russian patients with chronic CVD.

Currently, the RusR-Htn-CAD-CHF is focused on primary care in Russia. But in the near future, we plan to expand this registry to covering secondary care facilities.

Conclusion

The RusR-Htn-CAD-CHF is a perspective project for healthcare quality assessment in patients with Htn, CAD, and CHF, living in Russia. This registry can be used for dynamic monitoring and improving the quality of primary care (and secondary care in near future) in Russia. Additionally, the RusR-Htn-CAD-CHF can be used for different epidemiologic studies in Russian patients with Htn, CAD, and CHF.

Acknowledgments

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We thank all the participants of RusR-Htn-CAD-CHF. This Registry is funded by the Russian Ministry of Health as a part of the Health National Project.

Conflict of interest

None declared. The Russian Ministry of Health was not involved in the collection, analysis, and interpretation of data, in the manuscript preparation, or in making the decision to submit the paper. The authors have not received any financial support for the preparation of this paper.

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Authors:

Vladimir I. Gridnev - MD, DSc, Head of Department of New Cardiological Informational Technologies, Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia. http://orcid.org/0000-0001-6807-7934.

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Anton R. Kiselev - MD, DSc, Leading Researcher, Department of New Cardiological Informational Technologies, Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia. http://orcid.org/0000-0003-3967-3950.

Olga M. Posnenkova - MD, DSc, Senior Researcher, Department of New Cardiological Informational Technologies, Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia. http://orcid.org/0000-0001-5311-005X.

Yulia V. Popova - MD, PhD, Researcher, Department of New Cardiological Informational Technologies, Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia. http://orcid.org/0000-0002-2402-7588.

Natalya V. Lazareva - MD, PhD, Senior Researcher, Department of Registries of Cardiovascular Diseases, Russian Cardiology Research and Production Complex, Moscow, Russia.

Olga A. Belova - Chief physician, Ivanovo Regional Cardiology Dispensary, Ivanovo, Russia.

Svetlana V. Romanchuk - MD, PhD, Director of Healthcare Department of Ivanovo Region, Ivanovo, Russia.

Mikhail D. Prokhorov - DSc, Head of Laboratory of Nonlinear Dynamics Modelling, Saratov Branch of the Institute of Radio Engineering and Electronics of Russian Academy of Sciences, Saratov, Russia. http://orcid.org/0000-0003-4069-9410.

Pavel Ya. Dovgalevsky - MD, DSc, Professor, Director of Research Institute of Cardiology, Saratov State Medical University n.a. V.I. Razumovsky, Saratov, Russia. http://orcid.org/0000-0001-6846-6219. Elena V. Oshchepkova - MD, DSc, Professor, Head of Department of Registries of Cardiovascular Diseases, Russian Cardiology Research and Production Complex, Moscow, Russia.

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2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Appendix A. Key data elements of the database of RusR-Htn-CAD-CHF

Code Recommended diagnosis Title of key data element Type of element Format of data

1 Personal data of patients

1.1 Htn, CAD, CHF Surname Text Any text

1.2 Htn, CAD, CHF First name Text Any text

1.3 Htn, CAD, CHF Middle name Text Any text

1.4 Htn, CAD, CHF Sex Binary Male Female

1.5 Htn, CAD, CHF Date of birth Date DD.MM.YYYY

1.6 Htn, CAD, CHF Date of registration in the RusR-Htn-CAD-CHF Date DD.MM.YYYY

1.7 Htn, CAD, CHF Address Text Any text

1.8 Htn, CAD, CHF Phone (one or more) Text Any text

1.9 Htn, CAD, CHF Number of pension insurance certificate Text Any text

1.10 Htn, CAD, CHF Number of health insurance policy Text Any text

1.11 Htn, CAD, CHF Social category Categorical (one of list) Working Pensioner Disabled Other Unknown

1.12 Htn, CAD, CHF Educa tion Categorical (one of list) Primary Average Specialized secondary Incomplete higher Higher Unknown

1.13 Htn, CAD, CHF Type of work Categorical (one of list) Physical Mental Not working Unknown

2 Past history

2.1 Htn, CAD Family history of coronary artery disease Categorical (one of list) Yes No Unknown

2.2 Htn Family history of hypertension Categorical (one of list) Yes No Unknown

2.3 Htn, CAD, CHF Smoking Categorical (one of list) Current smoker: <1 cigarettes/day Current smoker: 1-9 cigarettes/day Current smoker: 10-19 cigarettes/day Current smoker: 20-39 cigarettes/day Current smoker: >40 cigarettes/day Former smoker Never smoked Unknown

2.4 Htn, CAD, CHF Alcohol consumption Categorical (one of list) Alcohol drinking: <20 g/day Alcohol drinking: 20-59 g/day Alcohol drinking: 60-139 g/day Alcohol drinking: 140-179 g/day Alcohol drinking: >180 g/day No alcohol drinking Unknown

2.5 Htn, CAD, CHF The level of physical activity in lifestyle Categorical (one of list) Low Medium High Unknown

2.6 Htn, CAD, CHF Balanced diet Categorical (one of list) Yes No Unknown

2.7 CHF Inpatient treatment for cardiovascular diseases Date of admission, Discharge date DD.MM.YYYY, DD.MM.YYYY

3 Results of physical examination at the visit

3.1 Htn, CAD SBP, first measurement at visit Numeric 000 mmHg Unknown

3.2 Htn, CAD DBP, first measurement at the visit Numeric 000 mmHg

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2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Code Recommended diagnosis Title of key data element Type of element Format of data

Unknown

3.3 Htn, CAD SBP, second measurement at the visit Numeric 000 mmHg Unknown

3.4 Htn, CAD DBP, second measurement at the visit Numeric 000 mmHg Unknown

3.5 CAD, CHF Heart rate at the visit Numeric 000 beats/min Unknown

3.6 CAD, CHF Palpation Categorical (multiple choose) Bilateral ankle swelling Ripple of jugular veins Hepatojugular reflux Hepatomegalia

3.7 CAD, CHF Auscultation Categorical (multiple choose) Rattling in the lower lung Rattling on all lung fields The third tone in heart beat

3.8 Htn, CAD Height Numeric 000 cm Unknown

3.9 Htn, CAD Weight Numeric 000 kg Unknown

3.10 Htn, CAD Waist circumference Numeric 000 cm Unknown

3.11 CAD Complaints of chest pain or its equivalent Categorical (one of list) Yes No Unknown

3.12 CAD Characteristics of chest pain or its equivalent Categorical (multiple choose) Symptom has characteristic features and duration for chest pain Chest pain or its equivalent arises during physical exertion or emotional stress Chest pain or its equivalent passes alone and/or after taking nitroglycerin Not applicable (if in element 3.11 it was selected "No" or "Unknown")

3.13 CAD The level of physical activity associated with Categorical (one Usual daily physical activity does not cause chest pain or its

chest pain or its equivalent of list) equivalent Slight limitation of usual physical activity Significant limitation of usual physical activity Inability to perform any physical activity because of chest pain or its equivalent Unknown Not applicable (if in element 3.11 it was selected "No" or "Unknown")

3.14 CAD, CHF Complaint of dyspnea Categorical (one of list) Yes No Unknown

3.15 CAD, CHF Characteristics of dyspnea Categorical Paroxysmal nocturnal dyspnea

(прим.: если в пункте «Жалобы на одышку» (multiple choose) Dyspnea during usual physical activity

выбран «Имеется») Dyspnea during walking on level ground Dyspnea when climbing (uphill, stairs) Dyspnea at rest Orthopnoea Nocturnal cough Unknown Not applicable (if in element 3.14 it was selected "No" or "Unknown")

4 Results of instrumental examinations

4.1 Htn 24-hour ambulatory blood pressure Categorical (one Yes

monitoring of list) No

4.1.1 Htn 24-hour SBP Numeric 000 mmHg Unknown

4.1.2 Htn 24-hour DBP Numeric 000 mmHg Unknown

4.1.3 Htn Daytime SBP Numeric 000 mmHg Unknown

4.1.4 Htn Daytime DBP Numeric 000 mmHg Unknown

4.1.5 Htn Number of daytime measurements Numeric 00 Unknown

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2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Code Recommended diagnosis Title of key data element Type of element Format of data

4.2.1 Htn Self-monitoring SBP (mean) Numeric 000 mmHg Unknown

4.2.2 Htn Self-monitoring DBP (mean) Numeric 000 mmHg Unknown

4.2.3 Htn Duration of self-monitoring blood pressure Numeric 00 days Unknown

4.3 Htn, CAD, CHF Echocardiography Categorical (one of list) Yes No

4.3.1 Htn Left ventricular mass index Numeric 000 g/m2 Unknown

4.3.2 CAD, CHF LVEF Numeric 00 % Unknown

4.3.3 CHF Left ventricular diastolic dysfunction Categorical (one of list) Yes No Unknown

4.3.4 CAD Local contractility disorders Categorical (one of list) Yes No Unknown

4.3.5 CHF Pulmonary hypertension Categorical (one of list) Yes No Unknown

4.4.1 Htn, CAD, CHF ECG: conclusion Categorical (multiple choose) Left ventricular hypertrophy Signs of Q-wave myocardial infarction Signs of non-Q-wave myocardial infarction Tachyarrhythmia Atrioventricular block: 2 or 3 degree Atrial fibrillation or atrial flutter Other violations Normal Unknown

4.4.2 Htn Sokolow-Lyon index Numeric 00 mm Unknown

4.4.3 Htn Cornell product criteria Numeric 0000 mm*ms Unknown

4.5.1 Htn Duplex ultrasound: Intima media thickness Numeric 0.0 mm Unknown

4.5.2 Htn Duplex ultrasound: Atherosclerotic plaque in great arteries Categorical (one of list) Yes No Unknown

4.5.3 Htn Carotid-femoral pulse wave velocity Numeric 00.0 m/s Unknown

4.5.4 Htn Ankle-brachial index Numeric 0.0 Unknown

4.6 CAD, CHF Chest X-ray Categorical (multiple choose) Cardiomegaly Pleurisy Pulmonary vascular congestion or pulmonary edema None of the above Unknown

4.7 Htn Fundus examination by ophthalmologist Categorical (one of list) Hypertensive retinopathy Other Unknown

4.8 Htn, CHF Consulting with cardiologist Categorical (one of list) Yes No

4.9 CAD ECG during exercise Categorical (one of list) Yes No

4.9.1 CAD Results of ECG during exercise Categorical (one of list) Positive Negative Uncertain Unknown Not applicable (if in element 4.9 it was selected "No")

4.9.2 CAD ECG during exercise: The load duration Numeric 00.0 minutes Unknown Not applicable (if in element 4.9 it was selected "No")

4.9.3 CAD ECG during exercise: Maximal deviation of ST segment Numeric 00.0 mm Unknown Not applicable (if in element 4.9 it was selected "No")

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Code Recommended diagnosis Title of key data element Type of element Format of data

4.9.4 CAD ECG during exercise: Features of chest pain Categorical (one of list) No angina Angina occurs, but does not stop exercise test Angina causes to stop the test Unknown Not applicable (if in element 4.9 it was selected "No")

4.9.5 CAD ECG during exercise: METs Numeric 00.0 METs Unknown Not applicable (if in element 4.9 it was selected "No")

4.9.6 CAD Contraindications for exercise test Categorical (one of list) Yes Unknown Not applicable (if in element 4.9 it was selected "Yes")

4.10.1 CAD Physical stress echocardiography: Minimal LVEF Numeric 00 % Unknown

4.10.2 CAD Physical stress echocardiography: Stress-induced violations of local contractility Categorical (one of list) Yes No Unknown

4.11 CAD Dobutamine stress echocardiography: Stress-induced violations of local contractility Categorical (one of list) Yes No Unknown

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4.12 CAD Perfusion scintigraphy: Irreversible perfusion defect Categorical (one of list) Yes No Unknown

4.13.1 CAD Computerized tomography: Agatston score Numeric 000 HU Unknown

4.13.2 CAD Results of coronary computed tomography angiography Categorical (multiple choose) Yes (Additional dataset is presented in Appendix B) Unknown

4.14 CAD Results of coronary angiography Categorical (multiple choose) Yes (Additional dataset is presented in Appendix B) Unknown

5 Results of laboratory tests

5.1 Htn, CAD Blood glucose Numeric 00.0 mmol/L 000 mg/dL Unknown

5.2 Htn, CAD Glucose tolerance test: Blood glucose via 2 hours after glucose load Numeric 00.0 mmol/L 000 mg/dL Unknown

5.3 Htn, CAD Hemoglobin A1c Numeric 00.0 % Unknown

5.4 Htn, CAD Total cholesterol Numeric 00.0 mmol/L 000 mg/dL Unknown

5.5 Htn, CAD Triglycerides Numeric 00.0 mmol/L 000 mg/dL Unknown

5.6 Htn, CAD Low-density lipoprotein Numeric 00.0 mmol/L 000 mg/dL Unknown

5.7 Htn, CAD High-density lipoprotein Numeric 00.0 mmol/L 000 mg/dL Unknown

5.8 Htn, CHF Creatinine Numeric 000 micromoles/L 0.00 mg/dL Unknown

5.9 Htn Serum urea Numeric 00.00 mmol/L Unknown

5.10 Htn Uric acid Numeric 000.0 ^mol/L Unknown

5.11 CHF B-type natriuretic peptide (PNB) Numeric 000 Pg/ml 000 Pmol/ml

5.12 CHF N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) Numeric 0000 Pg/ml 000 Pmol/ml

5.13 Htn, CAD, CHF Serum potassium Numeric 000.0 mmol/L Unknown

5.14 CHF Serum sodium Numeric 000.0 mmol/L Unknown

5.15 CHF Serum chloride Numeric 000.0 mmol/L

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Code Recommended diagnosis Title of key data element Type of element Format of data

Unknown

5.16 CAD Hemoglobin Numeric 000 g/L Unknown

5.17 Htn Urine protein Numeric 0.000 g/L Unknown

5.18 Htn 24-hour urine protein Numeric 000.0 mg/day Unknown

5.19 Htn Albumin/creatinine ratio in urine Numeric 00 mg/g 0.0 mg/mmol

6 Non-pharmacologic treatment

6.1 Htn Subject who was trained in the School for hypertensive patients Categorical (one of list) Yes Unknown

6.2 CHF Subject who was trained in the School for patients with CHF Categorical (one of list) Yes Unknown

6.3 Htn, CAD, CHF Patient who received advice on the rational consumption of alcohol Categorical (one of list) Yes Unknown

6.4 Htn, CAD, CHF Patient who received advice on smoking cessation Categorical (one of list) Yes Unknown

6.5 Htn, CAD, CHF Patient who received advice on rational physical activity Categorical (one of list) Yes Unknown

6.6 Htn, CAD, CHF Patient who received advice on rational diet Categorical (one of list) Yes Unknown

6.7 Htn, CAD, CHF Patient who received advice on weight normalization Categorical (one of list) Yes Unknown

7 Drug treatment

7.1.1 Htn, CAD, CHF ACE-ls Categorical (one of list) Yes No

7.1.2 Htn, CHF Adverse reactions to ACE-ls and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.1.3 Htn, CAD, CHF Angioedema Categorical (one of list) Yes Unknown Not applicable (if in element 7.1.2 it was selected "Unknown")

7.2.1 Htn, CAD, CHF ARBs Categorical (one of list) Yes No

7.2.2 Htn, CHF Adverse reactions to ARBs and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.3 Htn Direct renin inhibitors Categorical (one of list) Yes No

7.4.1 Htn, CAD, CHF Beta-blockers Categorical (one of list) Yes No

7.4.2 Htn, CAD, CHF Adverse reactions to beta-blockers and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.5.1 Htn, CAD Dihydropyridine CCBs Categorical (one of list) Yes No

7.5.2 Htn, CAD Non-dihydropyridine CCBs Categorical (one of list) Yes No

7.5.3 Htn, CAD Adverse reactions to CCBs and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.6.1 Htn, CHF Thiazide diuretics Categorical (one of list) Yes No

7.6.2 Htn, CHF Potassium-sparing diuretics Categorical (one of list) Yes No

7.6.3 Htn, CHF Loop diuretics Categorical (one of list) Yes No

7.6.4 Htn, CHF Adverse reactions to diuretics and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.7 Htn Alpha-blockers Categorical (one of list) Yes No

7.8 Htn Imidazoline receptor agonists Categorical (one of list) Yes No

7.9 Htn Other antihypertensive drugs Categorical (one of list) Yes No

7.10.1 CAD, CHF Statins Categorical (one Yes

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Code Recommended diagnosis Title of key data element Type of element Format of data

of list) No

7.10.2 CAD, CHF Adverse reactions to statins and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.11.1 Htn, CAD, CHF Aspirin Categorical (one of list) Yes No

7.11.2 Htn, CHF Adverse reactions to aspirin and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.12.1 Htn, CAD, CHF Indirect-acting anticoagulants Categorical (one of list) Yes No

7.12.2 Htn, CHF Adverse reactions to indirect-acting anticoagulants and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.13.1 CAD Clopidogrel Categorical (one of list) Yes No

7.13.2 CAD Adverse reactions to clopidogrel and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.14.1 CAD, CHF Short-acting nitrates Categorical (one of list) Yes No

7.14.2 CAD, CHF Adverse reactions to short-acting nitrates and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.14.3 CAD, CHF Long-acting nitrates Categorical (one of list) Yes No

7.14.4 CAD, CHF Adverse reactions to long-acting nitrates and/or idiosyncrasy Categorical (one of list) Yes Unknown

7.14.5 CAD Number of nitroglycerin tablets per week Numeric 00 tablets/week

7.15 CHF Hydralazine Categorical (one of list) Yes No

7.16 CHF Digoxin Categorical (one of list) Yes No

8 Invasive treatment

8.1.1 Htn, CAD PCI Categorical (one of list) Yes No

8.1.2 CAD Results of PCI: residual stenosis Categorical (multiple choose) Yes (Additional dataset is presented in Appendix B) Unknown

8.1.3 CAD Contraindications for PCI Categorical (one of list) Yes Unknown

8.1.4 CAD Number of stents Numeric 0 Unknown

8.1.5 CAD Type of stents Categorical (one of list) With drug-coated Uncovered Unknown

8.2 Htn, CAD Surgical coronary revascularization Categorical (one of list) Yes No

9 Diagnosis and its codes according to the International Classification of Diseases 10 (ICD-10)

9.1.1 Htn, CAD Stable angina (I20.8) Categorical (one of list) Yes No

9.1.2 CAD Angina functional class according to the Canadian Cardiovascular Society grading of angina pectoris Categorical (one of list) I class II class III class IV class Unknown

9.2 Htn, CAD, CHF Old myocardial infarction (I25.2) Categorical (one of list) Yes No

9.3 CAD Other forms of chronic ischemic heart disease (I25.0, I25.1, I25.3, I25.4, I25.5, I25.6, I25.8, I25.9) Categorical (one of list) Yes No

9.4 Htn, CAD Essential (primary) hypertension (I10) Categorical (one of list) Yes No

9.5.1 Htn Renovascular hypertension (I15.0) Categorical (one of list) Yes No

9.5.2 Htn, CAD Bilateral renal artery stenosis Categorical (one of list) Yes No

9.6 Htn Other secondary hypertension (I15.1, I15.2, I15.8, I15.9) Categorical (one of list) Yes No

9.7.1 Htn, CAD, CHF CHF (I50) Categorical (one of list) Yes No

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Code Recommended diagnosis Title of key data element Type of element Format of data

9.7.2 CAD, CHF Functional class of CHF according to the New York Heart Association Functional Classification Categorical (one of list) I class II class III class IV class Unknown

9.8 Htn Cerebral infarction (I63) Categorical (one of list) Yes No

9.9 Htn Intracerebral haemorrhage (I60, I61, I62) Categorical (one of list) Yes No

9.10 Htn Stroke, not specified as haemorrhage or infarction (I64) Categorical (one of list) Yes No

9.11 Htn Atherosclerotic peripheral arterial disease (I70) Categorical (one of list) Yes No

9.12 Htn Transient cerebral ischaemic attacks and related syndromes (G45) Categorical (one of list) Yes No

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9.13 Htn Discirculatory encephalopathy (I65, I66, I67.2, I67.3, I67.4, I67.8, F01, I69) Categorical (one of list) Yes No

9.14 Htn Dissecting aortic aneurysm (I71.0) Categorical (one of list) Yes No

9.15 Htn, CAD Diabetes mellitus (E10-E14) Categorical (one of list) Yes No

9.16.1 Htn, CAD, CHF Chronic lower respiratory diseases (J40-J47) Categorical (one of list) Yes No

9.16.2 Htn, CAD Asthma (J45) Categorical (one of list) Yes No

9.17 Htn Gout (M10) Categorical (one of list) Yes No

9.18 Htn, CAD Pregnancy Categorical (one of list) Yes No Not applicable (if in element 1.4 it was selected "Male")

9.19 CHF Cirrhosis of liver (K74.3-K74.6) Categorical (one of list) Yes No

9.20 CAD Other deseases provoking or aggravating ischemia Categorical (one of list) Yes No

9.21 CAD Other deseases provoking, aggravating, or simulating chest pain Categorical (one of list) Yes No

Data elements, preferred to fill in patients with Htn and/or CAD and/or CHF, signed in column "Recommended diagnosis".

DD.MM.YYYY is day, month and year. ACE-Is, angiotensin converting enzyme inhibitors; ARBs, angiotensin II receptor blockers; CAD, coronary artery disease; CCBs, calcium channel blockers; CHF, chronic heart failure; DBP, diastolic blood pressure; ECG, electrocardiogram; Htn, hypertension; HU, Hounsfield units; LVEF, left ventricle ejection fraction; METs, metabolic equivalents of task; PCI, percitaneous coronary intervention; SBP, systolic blood pressure.

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Appendix B. Addition data elements for coronary anatomy used in the RusR-Htn-CAD-CHF

Segments Title Stenosis or residual stenosis TIMI

Segment 1 Proximal part of right coronary artery 00 % 0

Segment 2 Middle part of right coronary artery 00 % 0

Segment 3 Middle part of right coronary artery 00 % 0

Segment 4 Posterior descending (interventricular) artery 00 % 0

Segment 5 Trunk of left coronary artery 00 % 0

Segment 6 Proximal part of anterior descending (interventricular) artery 00 % 0

Segment 7 Middle part of anterior descending (interventricular) artery 00 % 0

Segment 8 Middle part of anterior descending (interventricular) artery 00 % 0

Segment 9 First diagonal branch 00 % 0

Segment 10 Second diagonal branch 00 % 0

Segment 11 Proximal part of circumflex artery 00 % 0

Segment 12 First blunt marginal branch 00 % 0

Segment 13 Middle part of circumflex artery 00 % 0

Segment 14 Other blunt segments 00 % 0

Segment 15 Right posterolateral segment and branches 00 % 0

Bypass 00 % 0

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Appendix C. Clinical indicators for assessment of quality of healthcare in patients with Htn, CAD, and CHF

Title of indicators | Definitions

Control of cardiovascular risk factors

1. BP control Numerator: [Patients with Htn and/or CAD and/or CHF who have last BP <140/90 mmHg] AND [Patients with Htn and/or CAD and/or CHF who have last BP is >140/90 mmHg under treatment with 2 or more antihypertensive drugs]. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criteria: i) There are no data on BP at the last 12 months. ii) Secondary hypertension.

1A. Target BP is reached Numerator: Patients with Htn and/or CAD and/or CHF who have last BP <140/90 mmHg. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criteria: i) There are no data on BP at the last 12 months. ii) Secondary hypertension.

1B. Target BP is not reached, but assigned 2 or more antihypertensive drugs Numerator: Patients with Htn and/or CAD and/or CHF who have last BP is >140/90 mmHg under treatment with 2 or more antihypertensive drugs. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criteria: i) There are no data on BP at the last 12 months. ii) Secondary hypertension.

2. Control of physical activity Numerator: [Patients with AH and/or CAD and/or CHF with optimal physical activity] AND [Patients with AH and/or CAD and/or CHF with low physical activity who received advice to increase physical activity]. Denominator: Patients with AH and/or CAD and/or CHF. Exclusion criterion: There are no data on physical activity at the last 12 months.

2A. The proportion of patients with optimal physical activity Numerator: Patients with Htn and/or CAD and/or CHF with optimal physical activity. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on physical activity at the last 12 months.

2B. The proportion of patients with low physical activity who received advice to increase physical activity Numerator: Patients with Htn and/or CAD and/or CHF with low physical activity who received advice to increase physical activity. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on physical activity at the last 12 months.

3. Smoking control Numerator: [Non-smoking patients with Htn and/or CAD and/or CHF] AND [Smoking patients with Htn and/or CAD and/or CHF who received advice to smoking cessation]. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on smoking (or non-smoking) at the last 12 months.

3A. The proportion of nonsmoking patients Numerator: Non-smoking patients with Htn and/or CAD and/or CHF. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on smoking (or non-smoking) at the last 12 months.

3B. The proportion of smoking patients who received advice to smoking cessation Numerator: Smoking patients with AH and/or CAD and/or CHF who received advice to smoking cessation. Denominator: Patients with AH and/or CAD and/or CHF. Exclusion criterion: There are no data on smoking (or non-smoking) at the last 12 months.

4. Body mass control Numerator: [Patients with Htn and/or CAD and/or CHF who have normal body mass] AND [Patients with Htn and/or CAD and/or CHF who have excess body mass and received advice to mass loss]. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on body mass at the last 12 months.

4A. The proportion of patients with normal body mass Numerator: Patients with Htn and/or CAD and/or CHF who have normal body mass. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criteria: There are no data on body mass at the last 12 months.

4B. The proportion of patients with excess body mass who received advice to mass loss Numerator: Patients with Htn and/or CAD and/or CHF who have excess body mass and received advice to mass loss. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on body mass at the last 12 months.

5. Diet control Numerator: [Patients with Htn and/or CAD and/or CHF who observe a balanced diet] AND [Patients with Htn and/or CAD and/or CHF with have unhealthy diet and received advice to improve diet]. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on compliance with a balanced diet at the last 12 months.

5A. The proportion of patients with balanced diet Numerator: Patients with Htn and/or CAD and/or CHF who observe a balanced diet. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on compliance with a balanced diet at the last 12 months.

5B. The proportion of patients with unhealthy diet who received advice to improve diet Numerator: Patients with Htn and/or CAD and/or CHF with have unhealthy diet and received advice to improve diet. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on compliance with a balanced diet at the last 12 months.

6. Blood cholesterol control Numerator: Patients with Htn and/or CAD and/or CHF who have blood cholesterol <190 mg/dL and LDL <115 mg/dL during last 12 months. Denominator: Patients with Htn and/or CAD and/or CHF. Exclusion criterion: There are no data on blood cholesterol and/or LDL at the last 12 months.

6A. The proportion of patients with CAD and LDL <100 mg/dL during last 12 months Numerator: Patients with CAD who have LDL <100 mg/dL during last 12 months. Denominator: Patients with CAD. Exclusion criterion: There are no data on LDL at the last 12 months.

ISSN 2304-3415, Russian Open Medical Journal

2017. Volume 6. Issue 2. Article CID e0201 DOI: 10.15275/rusomj.2017.0201_

Title of indicators Definitions

Healthcare in patients with CAD

1. The proportion of patients Numerator: Patients CAD who received antiplatelet agents (aspirin or clopidogrel) at the last visit during last 12 months.

with CAD who received Denominator: Patients with CAD.

antiplatelet agents Exclusion criterion: Contraindications to aspirin and clopidogrel.

2. The proportion of patients Numerator: Patients with CAD who received statin medication during last 12 months.

with CAD who received statin Denominator: Patients with CAD.

medication Exclusion criterion: Contraindications to statin medication.

2A. The proportion of patients Numerator: Patients with CAD and last level of LDL >100 mg/dL who received statin medication during last 12 months.

with CAD and LDL >100 mg/dL Denominator: Patients with CAD.

who received statin medication Exclusion criteria: i) Contraindications to statin medication. ii) There are no data on LDL at the last 12 months.

3. The proportion of patients Numerator: Patients with CAD who received beta-blockers during last 12 months.

with CAD who received beta- Denominator: Patients with CAD.

blockers Exclusion criterion: Absolute contraindications to beta-blockers.

3A. The proportion of patients Numerator: Patients with old myocardial infarction who received beta-blockers during last 12 months.

with old myocardial infarction Denominator: Patients with old myocardial infarction.

who received beta-blockers Exclusion criterion: Absolute contraindications to beta-blockers.

3B. The proportion of patients Numerator: Patients with CAD and LVEF <40% who received beta-blockers during last 12 months.

with CAD and LVEF <40% who Denominator: Patients with CAD and LVEF <40%.

received beta-blockers Exclusion criterion: Absolute contraindications to beta-blockers.

4. The proportion of patients Numerator: Patients with CAD who received ACE-Is or ARB during last 12 months.

with CAD who received ACE-Is Denominator: Patients with CAD.

or ARBs Exclusion criterion: Absolute contraindications to ACE-Is and ARBs.

4A. The proportion of patients Numerator: Patients with CAD and diabetes mellitus who received ACE-Is or ARB during last 12 months.

with CAD and diabetes mellitus Denominator: Patients with CAD and diabetes mellitus.

who received ACE-Is or ARBs Exclusion criterion: Absolute contraindications to ACE-Is and ARBs.

4B. The proportion of patients Numerator: Patients with CAD and LVEF <40% who received ACE-Is and ARBs during last 12 months.

with CAD and LVEF <40% who Denominator: Patients with CAD and LVEF <40%.

received ACE-Is or ARBs Exclusion criterion: Absolute contraindications to ACE-Is and ARBs.

Healthcare in patients with CHF

1. Assessment of LVEF in Numerator: Patients with CHF who have at least one measurement of LVEF during last 12 months.

patients with CHF Denominator: Patients with CHF. Exclusion criterion: none.

2. The proportion of patients Numerator: Patients with CHF who received ACE-Is or ARB during last 12 months.

with CHF who received ACE-Is Denominator: Patients with CHF.

or ARBs Exclusion criterion: Absolute contraindications to ACE-Is and ARBs.

2A. The proportion of patients Numerator: Patients with CHF and LVEF <40% who received ACE-Is and ARBs during last 12 months.

with CHF and LVEF <40% who Denominator: Patients with CHF and LVEF <40%.

received ACE-Is or ARBs Exclusion criterion: Absolute contraindications to ACE-Is and ARBs.

3. The proportion of patients Numerator: Patients with CHF who received beta-blockers during last 12 months.

with CHF who received beta- Denominator: Patients with CHF.

blockers Exclusion criterion: Absolute contraindications to beta-blockers.

3A. The proportion of patients Numerator: Patients with CHF and LVEF <40% who received beta-blockers during last 12 months.

with CHF and LVEF <40% who Denominator: Patients with CHF and LVEF <40%.

received beta-blockers Exclusion criterion: Absolute contraindications to beta-blockers.

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4. The proportion of patients Numerator: Patients with CHF and atrial fibrillation (or atrial flutter) who received indirect-acting anticoagulants during

with CHF and atrial fibrillation last 12 months.

(or atrial flutter) who received Denominator: Patients with CHF and atrial fibrillation (or atrial flutter).

indirect-acting anticoagulants Exclusion criterion: Contraindications to indirect-acting anticoagulants.

5. The proportion of subjects Numerator: Patients with CHF who were trained in the School for patients with CHF.

who were trained in the School Denominator: Patients with CHF.

for patients with CHF Exclusion criterion: none.

ACE-Is, angiotensin converting enzyme inhibitors; ARBs, angiotensin II receptor blockers; BP, blood pressure; CAD, coronary artery disease; CHF, chronic heart failure; LDL, low-density lipoprotein; LVEF, left nentricular ejection fraction; Htn, hypertension.

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