Abstract
Background:
Cardiovascular diseases (CVDs) account for over three-quarters of all deaths taking place in developing nations.
Objective:
The present study aims to stratify noncommunicable disease (NCD) patients using the Globorisk chart for predicting their 10-year risk of a major (fatal or nonfatal) CVD event and to estimate the level of agreement between this country-specific chart and the existing World Health Organization (WHO)/International Society of Hypertension (ISH) risk strata.
Methods:
A record-based cross-sectional analytical study was conducted in 2018 among adults attending the NCD clinic of one rural and one urban primary health center in Puducherry. Laboratory and office risk calculators of the Globorisk chart were used to calculate the risk.
Results:
The median age (interquartile range (IQR)) of the 760 study participants was 58 (50–65) years. When calculated using the Globorisk prediction chart, 22.1% (n = 168) of the participants had a <10% risk for any CVD event in the next 10 years, whereas the same risk was found in 71.1% (n = 540) by using the WHO/ISH risk chart. There was no agreement found between the two risk charts (k = 0.0174; P-value = 0.26).
Conclusion:
The Globorisk chart was found to identify more patients as belonging to the higher risk category as compared to WHO/ISH charts.
Keywords: Cardiovascular diseases, Globorisk, noncommunicable diseases
INTRODUCTION
Accounting for over three-quarters of all deaths taking place in low- and middle-income countries (LMIC), cardiovascular diseases (CVDs) rank among the top global causes of death.[1] The figures for CVD burden in India are more challenging because of early-onset and high case fatality rates.[2] Since the 1960s with the Framingham heart study, risk factors for the development of CVDs have been given much importance in clinical practice. The following decades showed us the effects of risk multiplication and multiple risk factors contributing to the same disease, which led to the development of risk assessment and risk reduction approaches for the control of CVDs.[3] In order to estimate a person’s risk of a fatal or nonfatal cardiovascular event during a specific period based on their level of risk factors, various prediction models (or risk scores) have been developed and are currently available within the health system.
The World Health Organization/International Society of Hypertension (WHO/ISH) risk prediction charts predict the 10-year risk for fatal or nonfatal cardiovascular events based on the age, gender, systolic blood pressure (SBP), smoking status, diabetic status, and blood cholesterol levels.[4] The WHO/ISH risk chart is available at 14 WHO epidemiological sub-region levels only, as the data and evidence at the country level were lacking. The relatively new Globorisk chart, developed by a team of collaborators under the Harvard School of Public Health, predicts the risk of a fatal or nonfatal cardiovascular event for patients at the country level for all countries in the world using the same parameters of WHO/ISH and also with the person’s country of residence using two separate charts, one for laboratory use and another for office use.[5]
There is limited evidence available on the utility of Globorisk charts among the Indian population. So, the present study aims to stratify noncommunicable disease (NCD) patients in the chronic disease clinics functioning in rural and urban primary health centers in South India using this country-specific risk prediction chart for predicting the 10-year risk of a major (fatal or nonfatal) cardiovascular event and to estimate the level of agreement between Globorisk and the existing WHO/ISH risk strata.
METHODOLOGY
Study design
A record-based cross-sectional analytical study was conducted at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) rural and urban health centers (JIRHC and JIUHC, respectively) for four months (July–October 2018).
Study setting and population
JIRHC caters to a population of around 10,000 spread over four villages with agriculture as the primary occupation, whereas JIUHC caters to a population of about 8000 spread over four wards along with the coastal areas of Puducherry where fishing is the major occupation.
The NCD clinic of these centers is a special clinic conducted on a weekly basis to provide comprehensive healthcare services for NCD patients exclusively by a team that includes the medical officer (MO), postgraduates, undergraduate intern trainees, nursing staff, and public health workers posted under the Department of Preventive and Social Medicine, JIPMER. Healthcare services provided in both centers are similar and include routine medical consultation, laboratory investigations, and the provision of medications for NCDs like diabetes, hypertension, thyroid disorders, bronchial asthma, and epilepsy. On each visit, that is, every month, a clinical including foot examination and blood pressure measurement is conducted for all patients.
Study participants
Records of adults aged between 40 and 79 years attending the NCD clinic of JIRHC and JIUHC in the study period were included in the study. Patients with severe disease states like established CVDs (angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, cerebrovascular disease, peripheral vascular disease, or after coronary revascularization or carotid endarterectomy), mean SBP (>180 mmHg), total blood cholesterol (TC) ≥345 mg/dL, or renal impairment are excluded from the study.
Study tools
The Globorisk chart employed both the laboratory and office risk calculators to determine the 10-year risk of a fatal or nonfatal cardiovascular event.[6] These calculators used various variables such as country, age, gender, smoking status, SBP, TC, and the presence of diabetes mellitus in the laboratory-based version. However, the office version included age, gender, SBP, smoking status, and BMI. For 36 patients with missing cholesterol values, the BMI was utilized to calculate the risk using the office chart.
The calculation of risk based on the WHO/ISH cardiovascular risk prediction charts was conducted using the whoishRisk package for R software.[7] In the WHO laboratory-based model, cardiovascular risk was determined based on factors such as age, sex, smoking status, diabetes status, SBP, and cholesterol levels (measured in mmol/L). On the other hand, the non-laboratory-based model of WHO replaced cholesterol and diabetes with BMI. Risk assessment was based on age, sex, smoking status, SBP, and BMI. The CVD risk within the WHO models is determined across 21 regions as defined by the Global Burden of Disease (GBD).
Study procedure and statistical analysis
Each patient in the NCD clinic has a comprehensive case record issued by the Medical Records Department (MRD) with a unique family folder number, which is updated during every visit by the health workers. Records of the patients are maintained at the center, both as case records and in the hospital information system (HIS) in MS-Excel. Records of around 898 patients receiving treatment from January 1, 2017 to June 30, 2018 were reviewed during the study period. The last recorded values within 3 months were considered for the assessment of cardiovascular risk. The updated data were analyzed using STATA 14 software (manufactured by StataCorp LP, College Station, Texas, USA). Age, SBP, and TC were expressed as median (interquartile range (IQR)). Categorical variables such as gender, tobacco, diabetes, and cardiovascular risk events were expressed as percentages. Diabetes status was determined based on the criteria outlined in the Guidelines for Management of Type 2 Diabetes issued by the Indian Council of Medical Research.[8] SBP and TC were further categorized based on NCEP (ATP III criteria) and Joint National Committee-7 (JNC-7) guidelines.[9,10] Behavioral habits and anthropometric and blood pressure measurements were measured based on the WHO STEPS questionnaire.[11] All current smokers and those who quit smoking in the last year are considered as smokers. The WHO Asia-Pacific guideline was used to classify body mass index.[12]
The risk scores calculated were categorized into five strata for the WHO/ISH chart: <10%, 10%–<20%, 20%–<30%, 30%–<40%, and ≥40%; and seven strata for the Globorisk chart: <5%, 5–9%, 10–19%, 20–29%, 30–39%, 40–49%, and ≥50%, respectively.[13] Globorisk categories were further clubbed for comparison with WHO/ISH. SBP <100 mm Hg and TC <4 mmol/l were considered in the lowermost strata while calculated in the WHO/ISH chart. Globally, there is no standard cutoff decided on stratifying the population into high-risk and low-risk categories for CVD events using both the models.[6,14] Based on the available literature, CVD risk events were categorized into low-risk models using a cutoff of <10% and high-risk models using a cutoff of >20% and >30%. The level of agreement between the two risk prediction methods was determined by weighted kappa.[15] A P-value <0.05 was considered to be statistically significant. We followed the Strengthening and Reporting of Observational Studies in Epidemiology (STROBE) checklist to report our study findings.
RESULTS
Out of all the registered 456 patients in JIRHC and the 442 in JIUHC, records of 362 (79%) and 398 (90%) patients, respectively, were included in the study.
The data presented in Table 1 indicates that the median age of the study participants was 58 (50–65) years, and more than two-thirds of them were females (70%). In the study, population diabetes was higher in rural areas (59%). The median SBP and TC were 130 (120–140) mm Hg and 168 (145–196), respectively. Three-fourths of the patients had their SBP (72%) and TC (77%) within normal limits.
Table 1.
Sociodemographic profile of study participants (n=760)
| Characteristics | Rural n=362 (%) | Urban n=398 (%) | Total n=760 |
|---|---|---|---|
| Age group (years) | |||
| 40–49 | 80 (22.1) | 88 (22.1) | 168 (22.1) |
| 50–59 | 113 (31.2) | 138 (34.7) | 251 (33.1) |
| 60–69 | 118 (32.6) | 109 (27.4) | 227 (29.8) |
| 70–79 | 51 (14.1) | 63 (15.8) | 114 (15.0) |
| Gender | |||
| Male | 122 (33.7) | 108 (27.1) | 230 (30.2) |
| Female | 240 (66.3) | 290 (72.9) | 530 (69.8) |
| Tobacco consumption | |||
| Yes | 31 (8.6) | 27 (6.8) | 58 (7.6) |
| No | 331 (91.4) | 371 (93.2) | 702 (92.4) |
| Diabetes present | |||
| Yes | 214 (59.1) | 200 (50.3) | 414 (54.4) |
| No | 148 (40.8) | 198 (49.8) | 346 (45.6) |
| SBP (in mm Hg) | |||
| < 140 | 250 (69.1) | 295 (74.1) | 545 (71.7) |
| ≥ 140 | 112 (30.9) | 103 (25.9) | 215 (28.2) |
| Total cholesterol (in mg/dL)* | (n=342) | (n=382) | 724 |
| Satisfactory (<200) | 286 (83.6) | 268 (70.2) | 554 (76.5) |
| Unsatisfactory (≥200) | 56 (16.4) | 114 (29.8) | 170 (23.4) |
*36 values (4.7%) are missing; SBP=systolic blood pressure
Figures 1 and 2 illustrate that the prevalence of individuals in the high-risk category (30 and above) was notably elevated when utilizing Globorisk compared to the WHO/ISH risk chart (15.3% versus 6.5%).
Figure 1.
Distribution of study participants based on WHO/ISH risk categories (N = 760); WHO/ISH = World Health Organization/International Society of Hypertension
Figure 2.
Distribution of study participants based on different Globorisk categories (N = 760)
The agreement between the WHO/ISH chart and the Globorisk chart in various risk categories: <10%, 10 to <20%, 20 to <30%, 30 to <40%, and >40% is depicted in Table 2. Specifically, it indicates agreement percentages of 22%, 39%, 25%, 3%, and 0%, respectively. The strata were weighted by 1, 0.94, 0.75, 0.44, and 0, respectively, for the calculation of weighted kappa. There was no agreement found (k = 0.0174), and the finding was not statistically significant. (P-value = 0.26).
Table 2.
Comparison of risk stratification in the study population using WHO/ISH and Globorisk charts (n=760)*
| Globorisk | WHO/ISH Risk Chart | |||||
|---|---|---|---|---|---|---|
|
| ||||||
| <10% | 10% to 20% | 20% to 30% | 30% to 40% | >=40% | Total | |
| <10% | 119 (22) | 23 (19) | 13 (25) | 7 (24) | 6 (29) | 168 (22) |
| 10% to 20% | 222 (41) | 46 (39) | 19 (37) | 9 (31) | 6 (29) | 302 (40) |
| 20% to 30% | 123 (23) | 27 (23) | 13 (25) | 8 (28) | 4 (19) | 175 (23) |
| 30% to 40% | 51 (9) | 16 (13) | 5 (10) | 1 (3) | 5 (24) | 78 (10) |
| >=40% | 25 (5) | 7 (6) | 1 (2) | 4 (14) | 0 | 37 (5) |
| Total | 540 | 119 | 51 | 29 | 21 | 760 |
WHO/ISH=World Health Organization/International Society of Hypertension
The stratification of the population into low-risk groups using a cutoff of <10% and high-risk groups for CVD events using a cutoff of >20% and 30% is illustrated in Table 3. In the low-risk model, more than half (53%) of the individuals having hypertension were categorized by WHO/ISH as having the lowest CVD risk category (risk <10%) compared to less than a quarter (19%) based on Globorisk. Ideally, both should have been as low as possible, considering uncontrolled hypertension is a risk for a CVD event. Similarly, more than half (58.2%) of the known diabetic individuals were categorized by WHO/ISH as the lowest CVD risk category (risk <10%) compared to less than a quarter (23%) based on Globorisk. In the high-risk model, when 20% is taken as the cutoff, it is found that 22% of the diabetic patients had a risk of a CVD event according to WHO/ISH compared to 38% based on Globorisk.
Table 3.
Characteristics of study participants using low-risk (<10%) and high-risk models (>20% and>30%) based on WHO/ISH and Globorisk prediction charts (n=760)
| Characteristics | n | Low-risk model Risk cutoff <10% n (%) |
High-risk model | ||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Risk cutoff >20% n (%) | Risk cutoff >30% n (%) | ||||||
|
|
|
|
|||||
| WHO/ISH | Globorisk | WHO/ISH | Globorisk | WHO/ISH | Globorisk | ||
| Age >60 years | 282 | 124 (43.9) | 68 (24.1) | 77 (27.3) | 114 (40.4) | 37 (13.1) | 49 (17.3) |
| Female | 530 | 367 (69.2) | 123 (23.2) | 78 (14.7) | 213 (40.1) | 39 (7.3) | 90 (16.9) |
| Tobacco present | 58 | 27 (46.5) | 14 (24.1) | 19 (32.7) | 26 (44.8) | 14 (24.1) | 12 (20.7) |
| Diabetes present | 414 | 241 (58.2) | 96 (23.1) | 91 (21.9) | 159 (38.4) | 45 (10.8) | 63 (15.2) |
| SBP >140 (in mm Hg) | 215 | 114 (53.0) | 41 (19.0) | 59 (27.4) | 91 (42.3) | 37 (17.2) | 43 (20.0) |
| Total cholesterol ≥200 (in mg/dL)* | 170 | 81 (47.6) | 43 (25.2) | 44 (25.8) | 62 (36.4) | 23 (13.5) | 23 (13.5) |
*36 values (4.7%) are missing; SBP=systolic blood pressure; WHO/ISH=World Health Organization/International Society of Hypertension
DISCUSSION
This study aims to stratify the NCD patients using the Globorisk chart for predicting the 10-year risk of a major (fatal or nonfatal) cardiovascular event in two different populations, that is, urban and rural. In our study, nearly one-fourth (22%) of the patients belong to the strata with <10% risk for CVD events in the next 10 years in both service areas by using the Globorisk chart. This study is unique in obtaining the above result because other studies have revealed a variable level of prevalence of CVD risk for <10% using other risk prediction charts (viz., Nigeria 86%, Cuba 89.7%, Iran 93.9%, Pakistan 79.2%, Georgia 83.1%, Sri Lanka 94.9%, Nepal 87.2%, and China 96.1%).[13]
WHO/ISH charts have identified a higher proportion of patients belonging to the low-risk category than the Globorisk chart in predicting CVD risk. The majority (71%) of patients were categorized as having <10% risk, while the same risk was attributed to only 22% of the patients by Globorisk.[,17,18]
The percentage of agreement was found to be very low in each category of risk into which the patients were divided – the highest being for the 10–<20% category for which there was 39% agreement, and the least being for ≥40% category, for which it was 0%. The weighted kappa statistic was used to measure the degree of deviation on an ordered scale and to take into account the effect of chance. However, it was found that there was no level of agreement between the two risk assessment tools.
Since there is no standard cutoff for stratifying populations into high-risk and low-risk categories for CVD events.[6,14] CVD risk events were categorized into low-risk models using a cutoff of <10% and high-risk models using a cutoff of >20% and >30%. In the low-risk model, participants who had aged more than 60 years, females, with tobacco intake, diabetics, uncontrolled hypertensive, and unsatisfactory cholesterol levels were higher in WHO/ISH risk as compared to the Globorisk prediction chart, whereas in the high-risk model, the above findings were comparatively lesser in the WHO/ISH chart. This shows that the WHO/ISH chart underestimates the real cardiac risk.[19] This could be due to many reasons. WHO/ISH chart is WHO region-specific, whereas Globorisk measures country-specific risk charts for predicting individuals’ 10-year risk of cardiovascular disease. It is unable to adequately recognize high-risk individuals – morbid obesity, sedentary lifestyle, and family history of NCDs – hence labeling them as low cardiac risk based on the six predefined parameters. Also, the antihypertensive and statin therapies alter the SBP and the TC misclassifying the risk categories.
The Globorisk prediction tool identified more patients as belonging to the high-risk category for a CVD event.[5] Moreover, 15% of the patients were assessed to have ≥30% risk by Globorisk against 7% as per the WHO/ISH charts. Similarly, 38% of the patients were assessed to have ≥20% risk by Globorisk against 13% as per the WHO/ISH charts. This demonstrates that Globorisk has the potential to become one of the best global parameters for CVD risk estimation. Given the rise of NCDs in LMIC, further calibration, validation, and economic studies may be needed to assess the cost-effectiveness of risk prediction by this tool in such settings.[20]
WHO/ISH charts have been recommended in LMIC.[21] The biggest advantage is its simplicity and the option of cholesterol.[22] However, as found in repeated studies regarding its inaccuracy, it will lead to undermining the risk and categorizing high-risk people into the low CVD group in LMIC.[14,16,23,24] This will further contribute to more resources being spent in resource-constraint settings, and yet high-risk people will be missed increasing the economic and health burden for all.
Risk-based prevention of CVD is a major strategy proposed by national and international guidelines.[6] CVDs can be prevented either by the total risk approach, that is, using simple time-saving prediction charts for screening the masses, or by a single risk approach, that is, by screening a single parameter like BP or TC. In LMIC, the former is preferred.[25,26] For this reason, proper policies need to be framed by the government. However, there is still no universal consensus on the threshold level (>30% vs. 20%) that is required to make a decision for treatment, and hence further studies need to be done using the Globorisk prediction chart.
CONCLUSION
Globorisk’s identification of a higher number of high-risk patients for CVD suggests its potential as a reliable global measure for assessing CVD risk. With the increasing incidence of NCDs in LMIC, additional research is essential to assess the cost-effectiveness of using this tool for risk prediction in these settings.
Ethical approval
The Jawaharlal Institute of Postgraduate Medical Education and Research Institutional Ethics Committee approved the study.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest to declare.
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