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      Burden of heart failure on patients from China: results from a cross-sectional survey

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          Abstract

          Purpose

          Little evidence exists on the burden that chronic heart failure (HF) poses specifically to patients in China. The objective of this study, therefore, was to describe the burden of HF on patients in China.

          Materials and methods

          A cross-sectional survey of cardiologists and their patients with HF was conducted. Patient record forms were completed by 150 cardiologists for 10 consecutive patients. Patients for whom a patient record form was completed were invited to complete a patient questionnaire.

          Results

          Most of the 933 patients (mean [SD] age 65.8 [10.2] years; 55% male; 80% retired) included in the study received care in tier 2 and 3 hospitals in large cities. Patients gave a median score of 4 on a scale from 1 (no disruption) to 10 (severe disruption) to describe how much HF disrupts their everyday life. Patients in paid employment (8%) missed 10% of work time and experienced 29% impairment in their ability to work due to HF in the previous week. All aspects of patients’ health-related quality of life (QoL) were negatively affected by their condition. Mean ± SD utility calculated by the 3-level 5-dimension EuroQol questionnaire was 0.8±0.2, and patients rated their health at 70.3 (11.5) on a 100 mm visual analog scale. Patients incurred costs associated with HF treatment, travel, and professional caregiving services.

          Conclusion

          HF is associated with poor health-related QoL and considerable disruption in patients’ lives. Novel and improved therapies are needed to reduce the burden of HF on patients and the health care system.

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          Most cited references 30

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          Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand.

          Treatment guidelines and strategies are often based on data from randomized controlled trials and observational clinical studies. These sources drive treatment decisions, yet the data they provide may have limited relevance to the wider population in real-world clinical practice due to the narrow selection criteria applied to patients in trials. Information used to inform clinical practice and improve patient outcomes can, therefore, be unreflective of real-world clinical situations. The purpose of this article is to assess the value of Adelphi Disease Specific Programmes (DSPs) as sources of real world data. DSPs are large, multinational, observational studies of clinical practice for a range of common chronic diseases. Treatment practice data are collected by physicians (n = 700) who are asked to provide information for the next 10 patients consulting for a specific condition. These patients (n = 7000) are also invited to fill out a self-completion form providing their own assessment of symptoms, expectations and quality of life. This article provides examples of the statistical techniques that have been employed to analyse the data in terms of cost/burden of illness, quality of life, disease severity and progression, compliance and adherence to therapy, impact of treatment guidelines and analyses of unmet need. DSPs can support clinical understanding of how diseases are managed including rationale for doctor decision-making and patient attitudes to their condition. Comparisons with other data sources and limitations of the programmes are discussed (including the fact that, unlike claims databases and registries, the DSPs are cross-sectional and not longitudinal).
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            Population health status in China: EQ-5D results, by age, sex and socio-economic status, from the National Health Services Survey 2008

            Purpose To measure and analyse national EQ-5D data and to provide norms for the Chinese general population by age, sex, educational level, income and employment status. Methods The EQ-5D instrument was included in the National Health Services Survey 2008 (n = 120,703) to measure health-related quality of life (HRQoL). All descriptive analyses by socio-economic status (educational level, income and employment status) and by clinical characteristics (discomfort during the past 2 weeks, diagnosed with chronic diseases during the past 6 months and hospitalised during the past 12 months) were stratified by sex and age group. Results Health status declines with advancing age, and women reported worse health status than men, which is in line with EQ-5D population health studies in other countries and previous population health studies in China. The EQ-5D instrument distinguished well for the known groups: positive association between socio-economic status and HRQoL was observed among the Chinese population. Persons with clinical characteristics had worse HRQoL than those without. Conclusions This study provides Chinese population HRQoL data measured by the EQ-5D instrument, based on a national representative sample. The main findings for different subgroups are consistent with results from EQ-5D population studies in other countries, and discriminative validity was supported. Electronic supplementary material The online version of this article (doi:10.1007/s11136-010-9762-x) contains supplementary material, which is available to authorized users.
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              Heart Failure Care in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

              Introduction In high-income countries (HICs), heart failure is a well-recognized public health problem representing a significant burden for patients and healthcare systems [1],[2]. For example, in the UK and US, heart failure is one of the leading causes of hospitalisation, and despite recent advances, outcomes remain poor [3]–[6]. Of those hospitalised for heart failure in the UK, about 10% will die during admission [6]. In the US, between 20% and 27% of those who survive to discharge will be re-admitted within 30 d [7], whilst 5-y mortality rates range between 40% and 65% amongst the US, UK, Netherlands, and Sweden [2]–[4],[8],[9]. The costs associated with heart failure care are also substantial. In many HICs, heart failure typically consumes 1%–2% of healthcare resources [2], mainly because of repeated admissions to hospitals and prolonged inpatient stays. With demographic changes and the epidemiological transition to non-communicable diseases [10],[11], heart failure is expected to become a major public health issue in low- and middle-income countries (LMICs). Yet systematic evidence for its current burden to patients and health services is limited [1],[2],[12]. In fact, the last review of the burden of heart failure in LMICs, conducted over ten years ago, found no population studies and concluded that published data on heart failure epidemiology were almost entirely absent from most populations across the world [12]. As a result, many of our assumptions regarding the current burden of this condition worldwide are based on extrapolations from studies conducted in HICs, which may not be appropriate [1],[2]. Therefore, we sought to conduct a systematic review of both published and unpublished data regarding the patterns of heart failure presentation, management, and outcomes in LMICs. Methods This systematic review was designed and undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [13]. A study protocol describing the methodology has been published previously [14]. In brief, we searched Medline, Embase, Global Health Database, and WHO regional databases for articles published between 1 January 1995 and 30 March 2014 with the subject terms “heart failure” or “cardiomyopathies” or any related terms AND “incidence”, “prevalence”, “cause*”, “etiology”, “aetiology”, “epidemiolog*”, “burden”, “management”, “treatment”, “prevent*”, “population based”, “community”, “trends”, “survey”, “surveillance”, “mortality”, “morbidity”, “fatalit*”, or “attack rate”. Relevant studies from LMICs on the epidemiology, diagnosis, management, and outcomes of heart failure were included. There were no language restrictions. We also scrutinised the reference lists of study reports and review articles, and inquired among our collaborators and international heart failure experts about any additional databases or studies of which they may be aware. We further searched the Institute for Health Metrics and Evaluation's Global Health Data Exchange as well as the websites of regional and country-specific societies of cardiology to identify further datasets. Figure 1 summarises the retrieval and selection process for studies and relevant databases. After removing duplicate reports, two reviewers independently screened all titles and abstracts for their potential eligibility and extracted data using a pre-designed form. Studies were eligible for inclusion if they reported on heart failure patients from LMICs as defined by the World Bank [15]. Studies must have reported on at least 100 cases and contained relevant information on demographic characteristics, prevalence, case fatality, underlying aetiology, or management of patients with heart failure. Studies confined to subgroups of patients with heart failure (for example, those that included only dilated cardiomyopathy or heart failure as a complication of acute myocardial infarction) were excluded, as were studies that clearly did not include a representative sample of patients from the setting chosen (for example, studies that selected people referred to an echocardiography department, or studies that excluded adult populations) [14]. Investigators of multinational studies that had not reported findings by country were contacted for country-specific data. 10.1371/journal.pmed.1001699.g001 Figure 1 Data acquisition flowchart. Quality Assessment In order to capture a comprehensive overview of heart failure in LMICs, a wide range of studies, each with differing objectives and designs, were included. Studies meeting the minimum quality requirement, as specified below, for inclusion were analysed for both methodological limitations and reporting quality, using items from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [16] (Tables 1–6). Specifically, the sample size of each study, the location and type of healthcare facility, diagnostic methods used, and patient selection criteria were documented. In addition, we assessed each study's specific methodological strengths and weaknesses as well as likely external validity. 10.1371/journal.pmed.1001699.t001 Table 1 Characteristics of Africa region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations Algeria [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with either a previous or new diagnosis of heart failure.Exclusion: patients with acute decompensated heart failure, or those in another clinic trial. Clinical diagnosis on the basis of the Framingham criteria. [71].91% of participants had an echocardiogram. 400 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. >90% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Cameroon [24] Prospective and retrospective elements 1998–2001 Consecutive patients ≥15 y of age admitted to the cardiology clinic and/or the medical wards of Yaounde General Hospital. Those who had not had an echocardiogram were excluded.A prospective phase was carried out between September and November 2001, where all patients with suspected heart failure were included (39 patients).A retrospective phase involved the use of case notes of those with heart failure admitted to the hospital and undergoing echocardiography between 1998 and September 2001 (128 patients). Clinical diagnosis on the basis of the Framingham criteria [71].All patients had an echocardiogram. 167 Strengths: All patients had echocardiographic assessment.Limitations: This is a study of a single regional tertiary referral centre set in a rural area that may not be representative of the broader population. Patients who had not had an echocardiogram were excluded, but it is unclear how many patients with a clinical diagnosis of heart failure were thus excluded and to what extent this reduces the generalizability of the study findings. Missing data unreported. Cameroon [29] Prospective 2002–2008 All consecutive patients diagnosed with congestive cardiac failure referred to the cardiac centre of St. Elizabeth Catholic General Hospital, Shisong, Cameroon. Clinical diagnosis on the basis of the Framingham criteria.Echocardiography used, but no indication if all patients underwent this investigation. 462 Strengths: Comprehensive prospective study encompassing all patients diagnosed within the study period. Loss to follow-up documented.Limitations: This is a study of a single regional cardiology referral centre that may not be representative of the broader population. Missing data not transparently accounted for. Democratic Republic of the Congo [32] Prospective 2003–2004 Every fourth patient admitted with heart failure as an inpatient having been seen at the cardiology clinic of the Lomo Medical Centre of the Heart of Africa Cardiovascular Centre in Kinshasa. Echocardiography. 100 Strengths: All patients had echocardiographic assessment.Limitations: This is a study of a single urban outpatient cardiology referral centre that may not be representative of the broader population. Missing data not transparently accounted for. Ghana [30] Prospective 1992–1995 Consecutive patients with heart failure referred to the National Cardiothoracic Centre, Accra, over 4 y. Framingham criteria.All patients had an echocardiogram performed. 572 Strengths: This centre receives referrals from all hospitals across the country, increasing the generalizability of the results. All patients had echocardiography.Limitations: Acknowledged potential for referral bias as patients at this single urban tertiary specialist centre may not be representative of heart failure management elsewhere. Unclear if there were missing data, and how they were accounted for. Nigeria [36] Retrospective 1995–2005 The case notes of 202 patients with heart failure were randomly selected from the outpatient and inpatient departments of University College Hospital, Ibadan. New York Heart Association classification. 202 Limitations: Retrospective study with uncertain diagnostic accuracy. Inpatient and outpatient management were not separated. This is a study of a single urban tertiary referral centre that may not be representative of the broader population. Missing data not transparently accounted for. Nigeria [34] Retrospective 1996–2005 All patients recorded as having a diagnosis of heart failure from the mortality records of the University of Ilorin Teaching Hospital Not specified. 228 Strengths: Comprehensive review of all deaths and their respective case notes from the hospital, limiting selection bias.Limitations: Uncertain diagnostic accuracy. This is a single urban teaching hospital providing services to north-central Nigeria. Although the hospital covers a large catchment area, the patients may nonetheless not be representative of the broader population. Nigeria [33] Prospective 1997–2001 Records of all patients admitted with cardiovascular disease to the Obafemi Awolowo University Teaching Hospitals Complex in Ife, Nigeria. Not specified. 386 Strengths: Single tertiary referral centre providing services to 10 million individuals in the southwest of Nigeria, increasing the study's generalizability.Limitations: Single centre, though with a large catchment area, may not be representative of the broader population. No standardised diagnostic criteria used. Nigeria [37] Retrospective 1998–2001 All patients admitted to the medical wards of the University of Uyo Teaching Hospital in southern Nigeria with heart failure during the dry seasons within the study period.Exclusion: Patients with renal disease or suspected coronary artery disease. Clinical features with the aid of blood results, chest radiography, electrocardiography, and echocardiography. The proportion receiving additional investigations is unknown. 245 Strengths: Comprehensive assessment of patients with heart failure as coded for by this hospital.Limitations: Single tertiary referral centre may not be representative of the broader population. Study was a retrospective study of case notes; consequently, diagnostic accuracy is uncertain. Proportions receiving additional gold-standard investigations, such as echocardiography, not documented. Nigeria [31] Retrospective 2001–2005 All adults ≥18 y with congestive cardiac failure admitted to the medical wards of the University of Port Harcourt Teaching Hospital.Exclusion: patients whose condition did not meet the Framingham criteria or who died within 24 h of admission. Framingham criteria. 423 Strengths: Clear diagnostic criteria. Comprehensive assessment of patients with heart failure.Limitations: Single tertiary referral centre may not be representative of the broader population. Retrospective assessment with uncertain accuracy of the aetiology of heart failure. Unclear what proportion received additional investigations such as echocardiography. Unclear how missing data were accounted for. Nigeria [22] Prospective May–June 2004 Consecutive patients ≥18 y with suspected heart failure presenting to outpatient department, wards, or the casualty unit of Jos University Teaching Hospital. Framingham criteria. 102 Strengths: Consecutive patients included, limiting potential for selection bias. Clear documentation of rationale behind sample size. Standardised diagnosis criteria used. Acknowledged limitations.Limitations: Single tertiary referral centre may not be representative of the broader population. Inpatient and outpatient sample not separated. Aetiology of heart failure ascertained by case notes and clinical findings on examination rather than gold-standard investigation. Echocardiography not available to all patients. Nigeria [26] Prospective 2006–2008 Consecutive patients ≥15 y with heart failure presenting to the University of Abuja Teaching Hospital. European Society of Cardiology guidelines.Echocardiography available for all patients. 340 Strengths: Large catchment area for this referral centre, improving generalizability. All patients had echocardiographic assessment, improving overall diagnostic accuracy and that of assigned underlying aetiologies of heart failure.Limitations: Single tertiary referral centre may reflect more severe cases or those of uncertain diagnosis, therefore not reflecting practice in the broader health service. Nigeria [27] Prospective 2006–2010 Clinical registry of consecutive individuals referred for the first time to the cardiology clinic of the University of Abuja Teaching Hospital.Exclusion: those with musculoskeletal chest pain or hepatic or renal failure. European Society of Cardiology guidelines.Echocardiography available from >95% of patients. 475 Strengths: Consecutive patients, reducing the risk of selection bias. Clear, standardised, diagnostic criteria. Documented use of the STROBE guidelines [16] for the reporting of observational studies.Limitations: Single tertiary referral centre may reflect more severe cases or those of uncertain diagnosis, therefore not reflecting practice in the broader health service. Nigeria [28] Prospective Unknown (published 2009) 177 consecutive individuals with heart failure presenting to the University College Hospital, Ibadan. Framingham criteria.All patients underwent an echocardiogram. 177 Strengths: Clear, standardised, diagnostic criteria. All patients had an echocardiogram, improving the accuracy of heart failure diagnosis and that of underlying aetiology. Catchment area of greater than 3 million individuals, improving the generalizability of the results. Clear explanation of statistical methods used.Limitations: Single tertiary referral centre may reflect more severe cases or those of uncertain diagnosis, therefore not reflecting practice in the broader health service. Senegal [38] Prospective January–June 2001 Selection criteria not specified. Urban hospital in Dakar. Clinical diagnosis.All patients underwent echocardiography. 170 Strengths: All patients underwent echocardiography, improving the likely accuracy of the diagnosis of heart failure and of assigned aetiology.Limitations: Single urban hospital in the capital may not reflect broader population with heart failure. Unclear selection criteria. South Africa [25] Prospective 2006 All patients with cardiovascular disease or presenting to the cardiology unit. Those with a de novo presentation with heart failure were included.Exclusion: those with acute ischaemic aetiology. Based on European Society of Cardiology guidelines.All patients had an echocardiogram. 844 Strengths: Sole cardiovascular centre for a population of 1.1 million individuals, increasing the generalizability of findings. All patients underwent echocardiographic assessment, improving likely accuracy of diagnosis and of underlying aetiology of each patient's heart failure. Clear documentation of data availability and criteria applied.Limitations: Exclusion of those with an ischaemic aetiology may underestimate the proportion of those with heart failure due to IHD. Urban hospital setting may not reflect the broader population. Sub-Saharan Africa [35] Prospective 2007–2010 Patients ≥12 y with acute heart failure confirmed by echocardiography were included.The study was conducted in the following countries: Sudan, Ethiopia, Kenya, Uganda, Mozambique, South Africa, Cameroon, Nigeria, Senegal.Exclusion: those with acute ST-elevation myocardial infarction, known severe renal failure, hepatic failure, or another cause of hypoalbuminemia. Unspecified signs and symptoms of heart failure.All patients had an echocardiogram. 1,006 Strengths: All patients had echocardiographic assessment, improving diagnostic accuracy. Clear documentation of missing data and loss to follow-up as well as how this was accounted for in analyses. First published data on heart failure from a number of African countries.Limitations: Urban single hospital centres included. Individual study sites often had very few patients enrolled (range from 10 to 200). Exclusion criteria may lead to the underestimation of IHD as a cause of heart failure. ∧ Previously unpublished data. 10.1371/journal.pmed.1001699.t002 Table 2 Characteristics of Americas region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations Argentina [23] Retrospective 1992–1999 All patients diagnosed with congestive heart failure, decompensated heart failure, or acute pulmonary oedema as recorded in the electronic vital statistics of a community hospital of Mar del Plata, Argentina. Not specified. 6,368 Strengths: Comprehensive study with limited selection bias.Limitations: Single community hospital that may not be reflective of broader patterns of heart failure prevalence. No standardised method for diagnosing heart failure, relying on discharge reports. Argentina [21] Prospective 1996–1997 Patients admitted to both the general medical and cardiology wards with decompensated chronic heart failure. Patients must have had heart failure, as diagnosed by the Framingham clinical criteria, for 30 d or more.Exclusion: acute heart failure due to an ischaemic event, those lost to follow-up, and those without an electrocardiogram and chest radiograph. Framingham criteria.Unspecified proportion received echocardiography. 751 Strengths: 31 centres from across Argentina, 42% of which were in Buenos Aires. Standardised diagnostic criteria. Clear statistical methods documented.Limitations: Centres were invited to take part rather than randomised. Uncertain proportion received echocardiographic confirmation. Exclusion criteria may lead to underestimation of IHD as an aetiology of heart failure. Argentina [43] Prospective 2002–2003 All patients >18 y hospitalised for decompensated chronic heart failure.Exclusion: heart failure secondary to a myocardial infarction or post-operatively. Investigator's discretion. 615 Strengths: 36 centres predominantly based around Buenos Aires or neighbouring regions. Comprehensive assessment of all patients with likely low selection bias.Limitations: Centres were not randomised, rather invited. Consequently, results may not reflect the broader management of heart failure amongst physicians with less of an interest in heart failure. No standard diagnostic criteria. Exclusion criteria may lead to underestimation of IHD as an aetiology of heart failure. Uncertain adjustment for those with missing data. Argentina [44] Prospective 2007 All patients >18 y of age were included if hospitalised for decompensated chronic heart failure.Exclusion: heart failure as a complication of a myocardial infarction or post-operatively. Investigator's discretion. 736 Strengths: 36 centres from across Argentina.Limitations: Centres invited to take part rather than randomised, and those that did may reflect clinicians with an interest in heart failure, affecting the broader generalizability of results. Exclusion criteria may lead to underestimation of IHD as an aetiology of heart failure. No standard diagnostic criteria. Uncertain adjustment for those with missing data or lost to follow-up. No standard diagnostic criteria for heart failure. Brazil [45] Retrospective 1992 to 2010 Patients admitted to public hospitals in São Paulo with heart failure. Not specified. 194,098 Strengths: From the Datasus registry, providing hospital episode statistics for the entire public health system of São Paulo.Limitations: Uncertain diagnostic criteria based on individual physician's discretion. Brazil [42] Prospective 1998–2000 Consecutive patients admitted to hospital with worsening symptoms of heart failure (NYHA functional classes III or IV).Exclusion: patients with heart failure due to valvular heart diseases, thyrotoxicosis, hypothyroidism, severe anaemia, amyloidosis, neoplasia, chronic non-cardiogenic pulmonary diseases, previous heart transplantation, chronic haemodialysis, or participation in drug protocols. Clinical diagnosis based on the Framingham criteria. 494 Strengths: Standardised diagnostic criteria.Limitations: University Teaching Hospital in São Paulo dedicated to cardiology. Exclusion criteria may further hinder generalizability. Only patients with NYHA functional class III or IV, so may not be generalizable to those with milder symptoms. The exclusion of patients with valvular heart disease may impact on the assignment of aetiologies of heart failure. Unclear how loss to follow up and missing data were accounted for. Brazil [40] Prospective 2001 98 consecutive patients admitted to participating public hospitals and 105 consecutive patients admitted to participating private hospitals within the 3-mo study period in the city of Niteroi with a Boston criteria score of 8 or more. Boston criteria score ≥8. 203 Strengths: Multiple hospitals within Niteroi, improving generalizability. Clear statistical methods reported. Just under half of patients were from the private sector, the remaining from the public sector, allowing direct comparison between these two groups and representation from a broader swathe of society.Limitations: The methods used to select the participating hospitals are unclear, as is the final number of sites included. Brazil [19] Prospective 2005–2006 Consecutive patients admitted with heart failure and systolic dysfunction. Clinical diagnosis with echocardiographic confirmation. 263 Limitations: Single urban centre that may not be representative of the patterns of care at the national level. Unclear how missing data and loss to follow-up were accounted for. Uncertain diagnostic criteria or proportion receiving echocardiography. Only patients with systolic dysfunction were included, possibly reducing the generalizability of results. Brazil [39] Prospective 2006–2008 Consecutive patients ≥18 y referred to heart failure clinic with a Boston score of ≥7. Individuals were all classed as living in rural areas as per the Brazilian Institute of Geography and Statistics. Boston criteria score ≥7.All patients underwent echocardiography. 166 Strengths: All patients had echocardiographic assessment. Standard diagnostic criteria.Limitations: Single centre study that may not be representative of the patterns of care at the national level. Brazil [46] Prospective Unknown (published 2008) Patients consecutively admitted to the emergency department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo over a period of 150 d with the diagnosis of decompensated heart failure. 100 out of the 212 patients initially assessed were retrospectively selected, for whom further details were collected. Not specified. 100 Strengths: Although there were no standard diagnostic criteria for heart failure itself, there were standard criteria for assigning aetiologies of heart failure.Limitations: Single urban tertiary referral centre that may not be representative of the patterns of care at the national level. No standard diagnostic criteria used. Method of selection of the 100 patients for whom more detailed analysis was performed unclear. Brazil [59] Prospective 16 unspecified months (published 2012). Tertiary centre in Salvador, Bahia, Brazil. Consecutive patients with a diagnosis of heart failure who had had echocardiography. Echocardiography. 383 Strengths: All patients had echocardiographic assessment. Standard criteria for the assignment of aetiologies.Limitations: Single urban tertiary referral centre that may not be representative of the patterns of care at the national level. Only those patients who had already had echocardiography were included. Endemic zone for Chagas disease, which may hinder the generalizability of the study. Brazil [67] Retrospective 2008 All patients with congestive heart failure treated at the outpatient clinic of Hospital das Clínicas of the Federal University of Goiás.Exclusion: those who died in 2008 (their medical records were incomplete) or who were not from the state of Goiás. Not specified. 144 Strengths: Unbiased case selection.Limitations: Retrospective use of case notes without specified diagnostic criteria. Single urban centre that may not be representative of the patterns of care at the national level. Patients who died within the time frame of the study were excluded, limiting the study to patients with less severe forms of heart failure. Brazil [65] Prospective 1997 100 patients were randomly selected from the outpatient department of the Hospital das Clinicas, a tertiary referral centre in São Paulo. Patients were included if they were found on echocardiography to have a LVEF of 10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. 78% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Colombia [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.72% had an echocardiogram. 211 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. >70% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Mexico [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.75% had an echocardiogram. 458 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. 75% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. ∧ Previously unpublished data. NYHA, New York Heart Association. 10.1371/journal.pmed.1001699.t003 Table 3 Characteristics of Eastern Mediterranean region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations Egypt [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.73% had an echocardiogram. 434 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. >90% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Iran#,∧ Retrospective 1998–2012 All 277 patients with heart failure from a dataset of 83,895 hospitalised patients in Iran.Unpublished dataset. Not specified. 277 Strengths: Multi-centre study.Limitations: Non-random selection of hospitals. Diagnostic criteria used unspecified. Iran [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.95% had an echocardiogram. 105 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. >90% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Lebanon [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.83% had an echocardiogram. 181 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. >80% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Pakistan [47] Retrospective 2002–2003 First presentation to Agha Khan University Hospital in Karachi with the diagnosis of new-onset congestive heart failure that met the Boston criteria.Exclusion: LVEF≥40%, prior diagnosis of systolic heart failure dating back 3 mo, underlying disease with expected survival of less than 6 months, known primary valvular heart disease (rheumatic or nonrheumatic), patient died in-hospital, or no follow-up available after discharge. Clinical diagnosis based on Boston criteria.All patients received echocardiography. 196 Strengths: All patients had echocardiographic assessment.Limitations: Single tertiary referral centre in Karachi may not be generalizable to the broader population. The exclusion of valvular heart disease may impact on the aetiologies ascribed to cases of heart failure. Similarly, the exclusion of those who died in hospital may affect the generalizability of the findings. Tunisia [70] ∧ Prospective 2008–2009 All outpatients ≥21 y of age with new or previously diagnosed heart failure.Exclusion: patients with acute decompensated heart failure. Framingham criteria.71% had an echocardiogram. 257 These data come from the I PREFER registry.Strengths: >10 centres. Sites were randomly selected, and all cardiologists within the country considered eligible. Missing data and loss to follow-up transparent. Prospective trial within a specified recruitment period. 71% had confirmation of heart failure through echocardiography.Limitations: Representative only of those attending outpatient cardiology services, excluding the acute sector or those patients in primary care with heart failure not under joint care of a cardiologist. Yemen [48] Prospective 2007–2008 First 100 consecutive patients admitted to Ibn Seena Central Hospital, Mukalla, with heart failure. All patients were required to have blood tests, electrocardiogram, echocardiogram, and chest radiogram.Exclusion: all patients who for any reason dropped from follow-up before investigation was completed (died, transferred, discharged) Framingham criteria.All patients underwent echocardiography. 100 Strengths: Clear diagnostic criteria for underlying aetiologies. All patients had echocardiographic assessment. Referral centre for a large catchment area.Limitations: Single urban tertiary referral centre may not be representative of the broader population of patients with heart failure. ∧ Previously unpublished data. # S. Rahimzadeh, F. Farzadfar F, and M. Ghaziani, unpublished data. 10.1371/journal.pmed.1001699.t004 Table 4 Characteristics of Europe region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations Romania [51] Retrospective 2006 459 consecutively admitted patients between January and December 2006 to the cardiology department with a discharge diagnosis of chronic heart failure. Not specified. 459 Limitations: Single urban general hospital may not be representative of the broader population of patients with heart failure. Diagnostic criteria not clear. Data recorded from hospital files. Unclear how missing data were accounted for. Romania [50] Prospective 2008–2009 All consecutive patients hospitalised with a primary diagnosis of acute heart failure syndromes.Exclusion: patients with high-output heart failure. European Society of Cardiology guidelines.80% of patients had an echocardiogram. 3,224 Strengths: National registry involving 13 sites, increasing the generalizability of its results. A large majority of patients had echocardiographic assessment. Both tertiary academic centres and general hospitals were included, increasing generalizability.Limitations: Unclear how missing data were accounted for, although this issue is acknowledged in their limitations section. Serbia [61] Cross-sectional Unknown Patients with chronic heart failure were recruited from an outpatient cardiology clinic at the Clinic for Cardiovascular Diseases, Clinical Center Niš.Exclusion: those who had had a worsening of symptoms or changes in treatment in the preceding 2 wk. European Society of Cardiology and echocardiography. 127 Strengths: All patients underwent echocardiography. Standardised diagnostic criteria.Limitations: Single urban centre may not be representative of the broader population. Unclear method of case ascertainment. Turkey [49] Retrospective 1997–1998 Medical records of consecutive patients admitted for congestive heart failure at 16 academic hospitals were selected for review: “The most recent, in average, 50 patients from each centre with sufficient data for CHF [congestive heart failure] in their files were included”. American Heart Association guidelines.81% had an echocardiogram. 661 Strengths: 16 centres from across the country. A large majority of individuals had echocardiographic assessment.Limitations: Results from academic hospitals may not be generalizable to the broader health system. Method of case ascertainment may lead to selection bias. Unclear how missing data were accounted for. Turkey [64] Prospective 1999–2000 A survey was conducted of a random sample of 117 primary care physicians from across Turkey who logged all patients they saw with heart failure. Not specified. 876 Strengths: Real-world practice taken from a random sample of 117 primary care physicians from across Turkey.Limitations: Diagnosis of heart failure left to the clinicians. Turkey [63] Prospective 2005 A sample of 4,650 randomly selected individuals had their height, weight, blood pressure measured as well as an ECG and blood taken for NT-proBNP level. Any of the sample with a cardiac history, abnormal ECG, or NT-proBNP ≥120 pg/ml was further investigated with echocardiography. Echocardiography. 320 Strengths: Population-based random sample of individuals may provide generalizable information on prevalence of heart failure. ECG, electrocardiogram. 10.1371/journal.pmed.1001699.t005 Table 5 Characteristics of South East Asia region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations India [69] ∧ Retrospective 2008–2012 Billing codes from hospital used to identify patients with heart failure in Andhra Pradesh. Not specified. 5,758 Strengths: This study of billing data is from a large sample of over 1.5 million hospitalisations.Limitations: Billing data rely on clinical coding, and consequently there are no standardised diagnostic criteria available. Indonesia [20] Prospective 2006 Consecutively hospitalised patients ≥18 y in five hospitals. Patients with heart failure primarily being treated as a co-morbid rather than primary condition.Exclusion: those without an accessible medical record, those without acute decompensated heart failure. Not specified. 1,687 Indonesian arm of ADHERE-International.Strengths: Five hospitals, improving the potential generalizability of results. Missing data transparently accounted for. Echocardiographic assessment in 37.9% of patients.Limitations: Discharge data with lack of standardisation in the diagnosis of heart failure, which may lead to selection bias. Thailand [52] Retrospective 2006–2007 Consecutively hospitalised patients age more than 18 y at 18 cardiovascular centres. Patients with heart failure primarily being treated as a co-morbid rather than primary condition.Exclusion: those without an accessible medical record, patients with cardiogenic shock, and perioperative heart failure. Not specified. 1,612 Thai arm of ADHERE-International.Strengths: 18 cardiovascular centres from across the country, consequently greater generalizability of the results. 60.4% had echocardiographic assessment.Limitations: Discharge data with lack of standardisation in the diagnosis of heart failure, which may lead to selection bias. ∧ Previously unpublished data. 10.1371/journal.pmed.1001699.t006 Table 6 Characteristics of Western Pacific region studies and databases included. Country of Origin Study Design Recruitment Period Selection Criteria Heart Failure Definition Cases of Heart Failure Strengths and Limitations China [57] Retrospective 1980–2000 Patients admitted with heart failure to participating hospitals. Not specified. 1,756 Strengths: Multi-centre study may increase generalizability of results. Long study time period enabling analysis of trends across time.Limitations: Retrospective use of case notes, with consequent lack of standardised diagnostic criteria, may increase selection and reporting bias. China [58] Retrospective 1980–2008 Patients admitted to the medical wards during the study period. Not specified. 2,458 Strengths: Long time period of study allowed the analysis of medication prescription changes over time.Limitations: Urban single-centre study may not be generalizable to broader health service. Retrospective use of case notes without standardised diagnostic criteria for heart failure may increase reporting and selection bias. China [56] Retrospective 1995–2004 Patients admitted with heart failure. Not specified. 259 Limitations: Diagnostic criteria not standardised, leading to potential for reporting and selection bias. China [53] Retrospective 1995–2009 Patients admitted with heart failure to three university hospitals. American Heart Association 2005 guidelines. 1,119 Strengths: Multi-centre cohort study.Limitations: Academic centres may not reflect the broader health service. China [55] Retrospective 2007 Patients admitted with heart failure. Framingham criteria. 478 Limitations: Rural single-centre study that may not be generalizable to the broader health service. Retrospective analysis of case notes open to reporting bias. China [54] Retrospective 2008–2009 Patients admitted with heart failure. European Society of Cardiology 2005 guidelines 206 Limitations: Urban single-centre study that may not be generalizable to the broader health service. China [60] Prospective Unknown (published 2012) Individuals admitted to the People's Liberation Army General Hospital, Beijing, over the age of 60 y with a diagnosis of chronic heart failure.Exclusion: those with severe aortic stenosis, anticipated cardiac transplantation, or a left ventricular assist device. European Society of Cardiology 2008 guidelines. 327 Limitations: Single-centre army general hospital in the capital with a high proportion of male patients (78% of this cohort) may not be broadly generalizable. China [62] Prospective Unknown (published 2009) Cluster randomised sample of adults in primary care facilities with congestive heart failure in six counties of Liaoning Province. Framingham criteria. 529 Strengths: Cluster randomisation of primary care facilities, reducing potential for bias. Representation from six counties of Liaoning Province may improve regional generalizability of the results.Limitations: Uncertain diagnostic criteria and patient pool. Malaysia [68] ∧ Retrospective 2007–2008 Consecutive individuals with a principal discharge diagnosis of heart failure, using the relevant International Classification of Disease-9 codes. Patients with heart failure primarily being treated as a co-morbid rather than primary condition.Exclusion: patients 45% [76]. Here, 71% of individuals were prescribed ACEIs, 48% a mineralocorticoid receptor antagonist, and 61% a beta-blocker at discharge [76]. The corresponding figures across our dataset are 57%, 32%, and 34%, respectively. Across represented LMICs, patients admitted with heart failure had a poorer immediate prognosis than those in many HICs. However, as is the case for HICs, the estimates from LMICs varied substantially, although we found the difference between the two outlying regions in terms of prognosis, the Americas and South East Asia, was not statistically significant (p = 0.27). On average, the in-hospital mortality rate was 8.3% in LMICs, compared to 6.7% in the EuroHeart Failure II Survey [76] and 4% in ADHERE in the US [77]. Such differences, and the wide heterogeneity both within LMICs and between LMICs and HICs, may be due to different thresholds for hospitalisation or differences in patient characteristics, treatment strategies, or hospital characteristics. Reports of outcomes after hospital discharge were available from some studies, and these were more comparable to estimates from HICs [4],[6],[19],[42],[47]. Remarkable regional variation exists in the incidence of heart failure admissions to hospital. Of particular note is the low rate of reported admissions for heart failure in India and Iran. Unpublished data from India, based on the hospital billing codes assigned to patients from a sample of just under 1,551,410 admissions, showed an incidence of 0.37% [69]. Similarly, 0.3% of all hospital admissions were attributed to heart failure in a registry of over 80,000 hospitalisations across a number of hospitals in Iran (S. Rahimzadeh, F. Farzadfar F, and M. Ghaziani, unpublished data). These figures are an order of magnitude smaller than what is reported in HICs. There are several possible reasons for this observation. For example, it may be that in these countries, hospitals are still largely used for procedure-related activities, as opposed to pure medical management. In such a setting, treatment of medical conditions, such as heart failure, is much more likely to take place in the outpatient setting, for which data from India and Iran are lacking. Overall, the population-level incidence and prevalence of heart failure, despite its significance and dominance amongst cardiovascular diseases presenting to hospitals worldwide, remains largely unknown. Similarly, few data regarding the direct and indirect costs of heart failure are available in LMICs, information that is vital in understanding and measuring the value of different health service configurations and novel interventions. This review collates data over a time period of almost 20 y, which may be one explanation for the degree of heterogeneity in results between studies. However, when study period was analysed using meta-regression against the causes, management, and outcomes of heart failure, only three statistically significant effects were found. These included a rising percentage of patients in whom hypertension was reported as a contributing cause of heart failure, an increasing trend in the reported prescription of beta-blockers over time, and a substantial decline in in-hospital death rates (see Figures 14, 18, and 22). Although these associations are plausible and—in case of beta-blocker use and mortality rates—encouraging, they should be interpreted cautiously because of the potential for confounding. Limitations The data included are derived from a heterogeneous group of studies that set out with differing research goals. Variation in the methodologies used, particularly in methods of standardising the diagnosis and assessment of heart failure, may impact on some of the findings. These factors likely explain the high estimates of between-study variation that we found. Such variation may lead to underestimation of the true prevalence of heart failure, as well as inaccuracies in the causes ascribed to cases of heart failure. Our study includes individuals from three groups: those with their first presentation with acute heart failure, those with acute decompensation of chronic heart failure, and those with stable chronic heart failure seen in the outpatient clinic setting. Differences between healthcare systems may mean that the characteristics of patients seen in various settings may differ between countries, whilst adherence to gold-standard management may be more common amongst those with stable chronic heart failure seen in outpatient settings staffed by cardiologists than amongst those with acute heart failure treated in hospitals staffed by general internal physicians. In analysing these patients we have focussed on the evidence-based medical management methods common to all three groups. Combining data from 1995 to 2014, this study summarises management techniques over an almost 20-y period, an approach that may underestimate adherence to current management standards. However, when evaluated with meta-regression, the heterogeneity in a management variable was rarely found to be explained by changes over time. Another limitation of our study is that our data are derived from studies conducted for the most part in urban tertiary referral centres, which may not reflect the broader picture of heart failure in other hospitals and the community. Finally, despite the large number of studies included, information from some regions and for some outcomes was limited. In countries where few data are available, these results may not be truly reflective of the population and should therefore be interpreted as only a guide to the true prevalence, causes, and management of heart failure. Conclusion This review shows that heart failure places a considerable burden on health systems in LMICs, and affects a wide demographic profile of patients in these countries. Non-communicable diseases dominate the causes of heart failure across LMICs, although infectious valvular diseases and cardiomyopathies continue to impose a significant burden. Together, this suggests a double burden of communicable and non-communicable diseases for countries in the midst of epidemiological transition. In addition, we have identified high in-hospital mortality and wide variation and significant suboptimal use of pharmacological therapies. Further population-level studies, with clear case and outcome definitions, are needed for a more accurate assessment of heart failure in LMICs. Supporting Information Protocol S1 Study protocol: systematic review of the burden of heart failure in low- and middle-income countries. (PDF) Click here for additional data file. Checklist S1 PRISMA 2009 checklist. (DOC) Click here for additional data file.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2018
                08 June 2018
                : 12
                : 1659-1668
                Affiliations
                [1 ]Real World Research, Adelphi Real World, Bollington, UK
                [2 ]Real World Evidence, Cardio-Metabolics Franchise, Novartis Sweden AB, Stockholm, Sweden
                [3 ]Wellmera AG, Basel, Switzerland
                [4 ]Health Economics and Outcomes Research and Access Strategy, Novartis Pharma China, Beijing, China
                [5 ]Real World Evidence, Cardio-Metabolics Franchise, Novartis Pharma AG, Basel, Switzerland
                Author notes
                Correspondence: James DS Jackson, Adelphi Real World, Adelphi Mill, Grimshaw Lane, Bollington, Cheshire SK10 5JB, UK, Tel +44 162 557 7371, Fax +44 162 557 7294, Email james.jackson@ 123456adelphigroup.com
                Article
                dddt-12-1659
                10.2147/DDDT.S148949
                5996854
                © 2018 Jackson et al. This work is published and licensed by Dove Medical Press Limited

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