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WHO Non-Lab CVD Risk Charts in India

This study evaluates the concordance between laboratory-based and non-laboratory-based cardiovascular disease (CVD) risk assessment tools in a rural North Indian population. Conducted with 1,018 participants, it found that hypertension (39.4%) was the most prevalent risk factor, and the non-laboratory-based charts showed a high concordance rate of 83.3% with a kappa value of 0.64. The findings suggest that non-laboratory-based risk charts are effective for CVD risk estimation in resource-limited settings like India.

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0% found this document useful (0 votes)
17 views7 pages

WHO Non-Lab CVD Risk Charts in India

This study evaluates the concordance between laboratory-based and non-laboratory-based cardiovascular disease (CVD) risk assessment tools in a rural North Indian population. Conducted with 1,018 participants, it found that hypertension (39.4%) was the most prevalent risk factor, and the non-laboratory-based charts showed a high concordance rate of 83.3% with a kappa value of 0.64. The findings suggest that non-laboratory-based risk charts are effective for CVD risk estimation in resource-limited settings like India.

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jecklierose
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© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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WHO Non-Lab-Based CVD

Risk Assessment: A Reliable


Measure in a North Indian
Population ORIGINAL RESEARCH

P. ANANDA SELVA DAS


MAHASWETA DUBEY
RAVNEET KAUR
HARSHAL RAMESH SALVE
CHERIAN VARGHESE
BARIDALYNE NONGKYNRIH
*Author affiliations can be found in the back matter of this article

ABSTRACT CORRESPONDING AUTHOR:


P. Ananda Selva Das
Introduction: Timely, affordable, and sustained interventions reduce the risk of heart
Resident, Centre for
attack or Stroke in people with a high total risk of cardiovascular diseases (CVD). Risk Community medicine,
prediction tools are available to estimate the cardiovascular risk using information on Room. 14, Old OT block,
multiple variables. CVD risk charts prepared by the World Health Organization (WHO) Centre for Community
has laboratory-based and non-laboratory-based charts with the latter meant for use Medicine, All India Institute of
in resource limited settings. We conducted a study to determine concordance between Medical Sciences, New Delhi,
India
the laboratory- and non-laboratory risk charts and to estimate the prevalence of
anandaselvadas@[Link]
selected CVD risk factors in a rural Indian population.

Methods: A community-based cross-sectional study was conducted in rural area of


Ballabgarh in district Faridabad, Haryana. Sample of 1,018 participants aged 30–69
KEYWORDS:
years was selected randomly from study area. Information on CVDs risk factors was Non-communicable diseases;
obtained using WHO STEPS questionnaire, anthropometry and laboratory investigation. cardiovascular disease risk;
Risk distribution among the study participants was observed. Concordance between WHO CVD risk charts; risk
laboratory- and non-laboratory-based WHO CVD risk charts was determined using prediction; agreement; risk
factors
agreement analysis.

Results: The mean age of the study participants was 43.9 (8.9) years and 55.6%
TO CITE THIS ARTICLE:
participants were women. Among various CVD risk factors, hypertension (39.4%) was Ananda Selva Das P, Dubey M,
the major factor followed by overweight (34.1%) was found to be major factor, followed Kaur R, Salve HR, Varghese C,
by current smoking (23.6%) and hypercholesterolemia (18.7%). The concordance Nongkynrih B. WHO Non-Lab-
between the two charts was 83.3% with kappa value of 0.64. Considering laboratory- Based CVD Risk Assessment:
A Reliable Measure in a North
based charts as the gold standard, the sensitivity and specificity of non-laboratory-
Indian Population. Global
based risk charts at 5% risk as cut-off was 86.5% and 90.3% respectively. Heart. 2022; 17(1): 64. DOI:
Conclusion: The study shows a good agreement between the laboratory-based and [Link]
gh.1148
non-laboratory-based risk charts. Thus non-laboratory-based risk charts are suitable
for risk estimation of CVDs for use in resource limited settings like India.
1 INTRODUCTION Ananda Selva Das et al.
Global Heart
2

DOI: 10.5334/gh.1148
Cardiovascular diseases (CVDs) are leading cause of mortality and morbidity globally.
Ischemic heart disease and stroke are responsible for the majority of deaths due to CVDs
[1, 2]. CVDs are caused by an interaction of multiple risk factors which include tobacco use,
harmful alcohol use, physical inactivity, unhealthy diet, high blood pressure, high blood
glucose, high body mass index (BMI) and high blood cholesterol. Individual level attributes
such as age, sex, ethnicity/race, and family history of cardiovascular disease add to overall
risk [2]. Identification and addressing risk factor at right time among individual with high
risk would be helpful in the prevention of CVDs [3]. Risk prediction charts help to quantify
CVD risk by considering multiple risk factors and categorize individuals into high and low
risk. Timely and affordable interventions will reduce the risk of severe outcomes such as
heart attack, and hence will reduce premature mortality and disability. These CVD risk
charts are also good communication tools for monitoring behavior change at individual
level [3, 4].

Framingham Risk Score (FRS) was the first CVD risk prediction charts which was developed
based on the Framingham Heart Study. Later, multiple risk prediction charts were developed
and are in use (examples include SCORE, PROCAM, QRISK, Reynold Risk Score etc) [5–8]. But
most of these charts are based on the studies in high-income countries and may not be useful
to resource limited setting [9]. The World Health Organization (WHO) in association with
International Society of Hypertension (ISH) developed a risk prediction chart in 2007 which is
applicable to 14 WHO epidemiological regions. WHO updated the chart with two versions viz,
laboratory-based and non-laboratory-based in year 2019 with wider usability. The laboratory-
based WHO CVD risk charts require information on age, sex, smoking status, systolic blood
pressure, diabetes, and total cholesterol values to estimate the CVD risk in an individual. Risk
stratification is done as follows: <5% (green), 5% to <10% (yellow), 10% to <20% (orange),
20% to <30% (red), and ≥30% (dark red). This risk stratification is aligned with the WHO
recommendations for management of CVD risk. However, in resource constraint settings
where either availability or accessibility of laboratory investigations is limited these charts are
of no use. In such situation, non-laboratory-based risk charts using information such age, sex,
smoking status, systolic blood pressure and BMI, is an effective tool for CVD risk assessment.
Non-laboratory-based CVD risk charts are also useful for field level workers for screening and
referral of individuals at risk of CVD in the community [5, 10]. Risk stratification is similar to lab-
based charts, however its validity for use in resource limited setting like India is not yet studied.
Hence, we aimed to estimate the concordance between laboratory based and non-laboratory
based WHO risk charts.

2 METHODS
This was a community based cross-sectional study conducted from March 2020 to January
2021. The study was carried out in rural villages under Comprehensive Rural Health Services
Project (CRHSP), Ballabgarh in Faridabad district of Haryana in North India. The study area is
a health and demographic surveillance site and all demographic and health information are
stored in a computerized Health Management Information System (HMIS) [11]. Two villages
were selected for the study from the area. The sample size was calculated based on the
prevalence of diabetes (9.3%) reported in National Noncommunicable Diseases Monitoring
Survey 2017–2018 (NNMS 2017), with 2% absolute precision and 10% non-response, where
the minimum sample size required was 1000 [12]. Individuals in the age group of 30–69 years
in the study villages were enlisted from the HMIS and a simple random sampling was done to
select the participants. Participants with history of event of stroke or myocardial infarction were
excluded.

A semi-structured questionnaire, adapted from the WHO STEPS questionnaire, was used to
collect information about CVD risk factors. Anthropometric measurements (height and weight),
assessment of blood pressure, random blood glucose and lipid profile (total cholesterol,
triglycerides, high density lipoprotein and low-density lipoprotein) were carried out using
standard procedures and equipment.
The updated WHO CVD risk charts for South Asia, both laboratory-based and non-laboratory- Ananda Selva Das et al. 3
Global Heart
based charts were used to estimate the CVD risk among the participants. The risk charts give DOI: 10.5334/gh.1148
CVD risk in percentages and has been further categorized into 5 groups –<5%, 5–<10%, 10–
<20%, 20–<30% and ≥30%.

All current smokers and those who quit smoking less than one year before the assessment
were considered smokers; Hypercholesterolemia was defined as total cholesterol value of ≥
200 mg/dL; Body Mass Index (BMI) was calculated by the ratio of weight in kilograms divided by
square of height in meters. Subjects were classified as normal if the BMI was 18.5–24.99 kg/m2,
overweight if 25–29.99 kg/m2 and obese if BMI ≥ 30 kg/m2; High blood pressure was defined as
systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg; Hypertension
was defined as systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90
mm Hg or a history of taking anti-hypertensive medications or supported by documentation;
Raised blood glucose was defined as random blood glucose ≥ 200 mg/dL; Diabetes mellitus was
defined as random blood glucose ≥ 200 mg/dL or a history of taking anti-diabetic medications
or supported by documentation.

Statistical analysis: The data was collected digitally using Google forms. The collected data was
extracted to Microsoft Excel and was analyzed using STATA version14. Categorical variables
were expressed in percentages. Statistical significance between various categorical variables
and gender was assessed using Chi-square test and Fischer’s exact test, wherever applicable.
Concordance and non-concordance between the laboratory-based and non-laboratory-based
charts was calculated assuming the lab-based charts as reference. If the CVD risk calculated
by non-lab-based risk charts was higher than the risk calculated by lab-based risk charts, it was
described as overestimate and if lower, underestimate. Agreement between the two charts
was determined by Cohen’s kappa statistic. Sensitivity and specificity of non-laboratory-based
risk charts were calculated with laboratory-based risk charts considered as gold standard
(reference).

Ethical approval was obtained from the Institutional Ethics Committee, All India Institute of
Medical Sciences, New Delhi. (Ref. No.: IECPG-292/22.07.2020, RT-10/26.08.2020) Informed
written consent was taken from all the participants.

3 RESULTS
A total of 1,018 participants were enrolled in the study. The Mean (SD) age of the study
Table 1 Distribution of
participants was 43.9 (8.9) years. Majority (N, 70.3%) of the study participants were in the age participants by age & sex and
group of 30–49 years while only 2.9% in 60–69 years. Female participants (N, 55.6%) were prevalence of CVD risk factors
slightly more than the male participants (44.4%) (Table 1). by age groups (N = 1018).

AGE GROUP 30–39 40–49 50–59 60–69 TOTAL


n (%) n (%) n (%) n (%) n (%)

Gender

Male 142 (31.4) 168 (37.2) 129 (28.5) 13 (2.9) 452 (44.4)

Female 218 (38.5) 188 (33.2) 143 (25.3) 17 (3.0) 566 (55.6)

Total 360 (35.4) 356 (35) 272 (26.7) 30 (3.0) 1018 (100.0)

CVD RISK FACTORS % (95% CI)

Current smoking 10.6 (7.8–14.1) 24.2 (20.0–28.9) 39 (33.3–44.9) 33.3 (18.7–52.0) 23.6 (21.1–26.3)

Current smokeless tobacco 3.3 (1.9–5.8) 2.5 (1.3–4.8) 5.5 (3.3–9.0) 3.3 (0.4–20.8) 3.6 (2.6–5.0)

Current alcohol use 9 (6.5–12.5) 16.4 (12.9–20.7) 17.2 (13.1–22.2) 0.0 (0.0) 13.5 (11.6–15.8)

Hypercholesterolemia 13.9 (10.7–17.9) 19.4 (15.6–23.8) 24.3 (19.5–29.7) 16.7 (7.0–34.7) 18.7 (16.3–21.1)

Overweight 38.6 (33.7–43.8) 33.4 (28.7–38.5) 29.8 (24.6–35.5) 30 (16.2–48.9) 34.1 (31.3–37.2)

Obesity 11.1 (8.2–14.8) 12.4 (9.3–16.2) 13.2 (9.7–17.8) 13.3 (5.0–31.0) 12.2 (10.3–14.3)

Hypertension 29.4 (24.9–34.4) 41.6 (36.5–46.8) 44.5 (38.6–50.5) 86.7 (68.0–95.2) 39.4 (36.4–42.4)

Diabetes mellitus 3.9 (2.3–6.5) 8.7 (6.2–12.1) 9.2 (6.3–13.3) 20 (9.1–38.3) 7.5 (6.0–9.2)
Of all study participants, 23.6% (95% CI 21.1–26.3%) were smokers. Proportion of smoking Ananda Selva Das et al. 4
Global Heart
was higher among males (42.9%) than females (8.1%) and similarly, smokeless tobacco use DOI: 10.5334/gh.1148
was higher among males (7.5%). More than one third of the total participants were overweight
(34.2%, 95% CI 31.3–37.2%) and obese being 12.2% (95% CI 10.3–14.3%). Proportion of
obesity among females was 14.5% while it was 9.3% among males. Prevalence of self-reported
hypertension was 10.4% (95% CI 8.7–12.4%) while participants who had high blood pressure
during the data collection period was 34.6% (95% CI 31.7–37.6%). Prevalence of self-reported
diabetes was 2.6% (95% CI 1.7–3.7%) while participants with raised random blood glucose at Table 2 Distribution of CVD risk
the time of study was 7.1% (95% CI 5.6–8.8%). Prevalence of hypercholesterolemia was 18.7% factors of study participants
(95% CI 16.4–21.2%) (Tables 1 and 2). by sex (N = 1018).

VARIABLES MALE (n = 452, 44.4%) FEMALE (n = 566, 55.6%) TOTAL (n = 1018) p-VALUE
n (%) n (%) n (%)

Current smoking 194 (42.9) 46 (8.1) 240 (23.6) <0.001

Current smokeless tobacco use 34 (7.5) 3 (0.5) 37 (3.6) <0.001

Current alcohol use (30 days) 135 (29.9%) 1 (0.2) 136 (13.5%) <0.001

Overweight 161 (35.6) 187 (33.0) 348 (34.2) 0.07

Obesity 42 (9.3) 82 (14.5) 124 (12.2) 0.07

High blood pressure 173 (38.3) 179 (31.6) 352 (34.6) 0.03

Known case of Hypertension 21 (4.6) 85 (15.0) 106 (10.4) <0.001

Raised blood glucose 33 (7.3) 36 (6.4) 69 (6.8) 0.61

Known case of Diabetes mellitus 10 (2.2) 16 (2.8) 26 (2.6) 0.54

Hypercholesterolemia 75 (16.6) 115 (20.3) 190 (18.7) 0.13

3.1 RISK STRATIFICATION AND CONCORDANCE BETWEEN THE TWO CHARTS


Out of 1,018 participants, low CVD risk (<10%) was observed in 958 (94%) participants by
laboratory-based chart and 956 (93.9%) participants by non-laboratory-based chart. Details of
moderate- and high-risk assessment is described in Table 3.

Table 3 Agreement level


RISK LEVELS OF WHO LABORATORY-BASED CHART
between WHO Cardiovascular
<5% 5–9% 10–19% 20–29% ≥30% TOTAL Disease risk prediction charts
n (%) n (%) n (%) n (%) n (%) n with laboratory and non-
laboratory charts: (N = 1018).
Risk levels of WHO non-laboratory based chart

<5% 645 (63.4) 40 (3.9) 1 (0.1) 0 (0.0) 0 (0.0) 686 (67.4)

5–9% 68 (6.7) 175 (17.2) 27 (2.6) 0 (0.0) 0 (0.0) 270 (26.5)

10–19% 1 (0.1) 28 (2.8) 28 (2.8) 3 (0.3) 0 (0.0) 60 (5.9)

20–29% 0 (0.0) 1 (0.1) 1 (0.1) 0 (0.0) 0 (0.0) 2 (0.2)

≥30% 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

Total 714 (70.1) 244 (24) 57 (5.6) 3 (0.3) 0 (0.0) 1018 (100)

CHARACTERISTICS OF CONCORDANCE n (%)

Concordance 848 (83.3)

Non-concordance 170 (16.7)

Underestimate 71 (7)

Overestimate 99 (9.7)

K value-Cohen’s Kappa (95% CI) Agreement = 83.3%


Expected agreement = 53.9%
kappa – value = 0.64 (0.02)

The concordance between the laboratory-based and non-laboratory-based charts in CVD risk
classification of the participants into different risk categories was 848 (83.3%). Among the
170 participants with non-concordant risk estimates, 71 (58.2%) were overestimates and
99 (41.8%) were underestimates. Majority (98.8%) of the non-concordant belonged to risk Ananda Selva Das et al. 5
Global Heart
categories <20%. The Cohen’s kappa between the two charts was 0.64 (SE 0.02), reflecting DOI: 10.5334/gh.1148
good agreement. Considering lab-based charts considered as the gold standard, the sensitivity
and specificity of non-lab-based charts was 86.5% and 90.3% respectively (Table 3).

3.2 SENSITIVITY ANALYSIS


As the risk charts are meant to be used for people in the age group of 40–74 years, we did a
sensitivity analysis by removing participants in the age group of 30–39 years. The concordance
observed was 78.1% (514/658) between laboratory and non-laboratory-based risk charts.
Under-estimation by non-laboratory-based charts was 8.7% (57/658) while over-estimation
was 13.2% (87/658). The kappa statistic between the two also slightly decreased to 0.61 from
previous value of 0.64, but it still indicates good agreement between the two charts.

4 DISCUSSION
Drug therapy and counselling for individuals with high risk of developing fatal and non-fatal
cardiovascular disease (CVD) is a World Health Organization (WHO) best-buy intervention. Risk
prediction charts help identify high risk individuals and many tools have been developed over
the years. Although many studies have been published on CVD risk estimate using various risk
prediction charts including WHO/ISH risk charts, the present study is one of the first to estimate
CVD risk using the 2019 updated WHO CVD risk charts since its development.

Prevalence of current tobacco use in the present study was 25.7% as compared to 32.8% in
National Non-communicable disease survey (NNMS) 2017–18 and 28.6% in Global Adults
Tobacco Survey-2(GATS-2) but tobacco use (smoked) is higher in the present study due to the
widespread use of hookah in the study area [12, 16]. The prevalence of alcohol consumption
(13.6%) is comparable to that found in a study of substance use in India survey (14.6%) and
NNMS (15.9%) [12, 17]. Smoking and alcohol consumption was higher in men. The prevalence of
overweight and obesity found was 34.2% and 12.2% respectively which was much higher than
that found in NNMS 2017–18, 26.1% being overweight and 6.2% being obese. Obesity was higher
among women. The prevalence of raised blood pressure was 34.6% while the same was 28.5%
in NNMS 2017–18 and raised blood glucose was 6.8% as compared to 9.3% in NNMS 17–18.

In the present study, 94% had CVD risk <10% estimated by both the charts. It was observed that
there was a high concordance of 83.3% between the laboratory-based and non-laboratory-
based CVD risk charts. The 2019 WHO CVD risk charts have been recently developed and until
now, there are no published studies assessing the concordance between the laboratory based
and non-laboratory based WHO CVD risk charts. There are previous studies assessing the
concordance of WHO/ISH risk prediction tool between the charts with cholesterol and without
cholesterol levels, which reported concordance in the range of 86.3% to 89.5%. A study by Deori
et al. (2020) observed a concordance of 86.3% while concordance of 89.5% and 88.1% was
observed by Fatema et al. (2015) and Nordet et al. (2013) respectively [13–15]. In our study,
the kappa statistic between the two WHO CVD risk charts was 0.64. The kappa statistic shows a
good agreement between the two charts in 30–69 years age group and a concordance of 83.3%
suggests that non-laboratory-based risk charts can be a useful tool in resource limited settings.
Also, as non-laboratory-based risk charts do not require laboratory investigations for diagnosis
of diabetes mellitus and total cholesterol measurement, it can be used by the community
health workers to predict the CVD risk estimate of individuals at community level. According
to the guidelines, individuals with a total CVD risk level of 10% and above should receive an
assessment using laboratory-based charts after measurement for diabetes and cholesterol.

This was one of the first studies to assess the CVD risk using the updated 2019 WHO CVD risk
charts to determine the concordance between the lab-based and non-lab based WHO CVD
risk charts at community level setting. There were some limitations of the study. Firstly, we
included participants aged below 40 years, although the charts are applicable to 40 years and
above. Since the younger population is expected to have lower level of CVD risk, and exclusion
of persons above 69 years, the study may have underestimated the level of CVD risk in this
population. The reason for including people aged 30 and above is because the guidelines under
National Health Mission in India recommends screening from the age of 30 years. However,
a sensitivity analysis excluding the participants in the age group of 30–39 years showed that
the concordance was comparable to the concordance found in the overall study population. Ananda Selva Das et al. 6
Global Heart
Secondly, use of random blood glucose measurement by point of care device to diagnose DOI: 10.5334/gh.1148
diabetes mellitus may have led to a misclassification of people with diabetes.

5 CONCLUSION
The present study highlighted that there is low CVD risk using WHO CVD risk chart among adults in
rural community in north India. Good agreement between the WHO CVD laboratory-based and non-
laboratory-based risk charts was observed in the study. Thus, non-laboratory-based charts could be
considered for identifying the individuals who might benefit from laboratory-based risk assessment.
A risk stratification approach is particularly suitable to settings with limited resources, where saving
the greatest number of lives at lowest cost becomes imperative. A stepwise approach can be
considered starting with non-lab risk assessment and followed by laboratory-based risk; this will
help in optimizing resources. Additionally, the non-laboratory risk charts can be used for education
and advocacy regarding total CVD risk in areas where lab testing remains currently unavailable.

DATA ACCESSIBILITY STATEMENT


Dataset associated with the current paper is available from the corresponding author upon
reasonable request.

ACKNOWLEDGEMENTS
The authors are grateful to all participants in the study.

FUNDING INFORMATION
This research did not receive any specific grant from funding agencies in the public, commercial,
or not-for-profit sectors.

COMPETING INTERESTS
The authors have no competing interests to declare.

AUTHOR CONTRIBUTIONS
RK, HRS, CV, BN and ASD developed the concept and research protocol. ASD and MD collected
and analysed the data. RK, HRS, CV, BN and ASD participated in the multiple revisions of the
manuscript. All authors read and approved the final manuscript.

AUTHOR AFFILIATIONS
P. Ananda Selva Das [Link]/0000-0002-8332-8137
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India; Room. 14, Old OT
block, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India
Mahasweta Dubey [Link]/0000-0002-8905-1271
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India; Room. 18, Old OT
block, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India
Ravneet Kaur [Link]/0000-0001-8226-8614
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India; Room. 12, Old OT
block, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India
Harshal Ramesh Salve [Link]/0000-0002-5299-5762
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India; Room. 12, Old OT
block, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India
Cherian Varghese [Link]/0000-0001-6907-0451
Department of Noncommunicable Diseases, World Health Organization, Geneva, Switzerland
Baridalyne Nongkynrih [Link]/0000-0002-6088-9230
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India; Room. 18, Old OT
block, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India
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© 2022 The Author(s). This is an
Magnitude of Substance Use in India. New Delhi: Ministry of Social Justice and Empowerment,
open-access article distributed
Government of India.
under the terms of the Creative
Commons Attribution 4.0
International License (CC-BY
4.0), which permits unrestricted
use, distribution, and
reproduction in any medium,
provided the original author
and source are credited. See
[Link]
licenses/by/4.0/.
Global Heart is a peer-reviewed
open access journal published
by Ubiquity Press.

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