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Evaluation of the effectiveness of the Iran-package of essential non-communicable disease (IraPEN) program in reducing cardiovascular disease risk in pilot areas

Abstract

Background

To assess the effectiveness of the IraPEN program in decreasing the risk of cardiovascular disease (CVD) and associated risk factors in selected areas of Iran.

Methods

A secondary data analysis of longitudinal data collected between 2016 and 2017 from health centers in four pilot areas. The target population consisted of people aged 40 years and above, as well as individuals aged 30鈥40 years who had at least one CVD risk factor. We compared mean CVD risk and risk factor levels before and one year after the intervention and utilized Generalized Estimating Equations to analyze the trends during subsequent visits.

Results

A total of 160,223 eligible individuals (93,081 female) were screened at baseline, of which 25,764 individuals (17,386 female) were followed up for at least one year. The proportion of men with a CVD risk score above 10%, according to the WHO/ISH risk charts, decreased from 7.5 to 5.3%, while the proportion of women decreased from 6.1 to 4.7%. Based on the revised WHO risk score, the mean CVD risk for those with a risk score above 10% at baseline and one year later was 0.198 and 0.177 in men and 0.119 and 0.109 in women, respectively. There was a significant decrease in all risk factors, except for waist circumference in both sexes and BMI in women. The trend analysis of risk factors over time confirmed these findings.

Conclusion

The program was modestly effective in reducing CVD risk in the pilot areas. However, further modifications may be needed to enhance its effectiveness.

Peer Review reports

Introduction

Cardiovascular disease (CVD) is a major contributor to mortality, responsible for 31% of deaths worldwide, with 75% of these deaths occurring in low- and middle-income countries [1]. In the Eastern Mediterranean Region, the age-standardized Disability-Adjusted Life Years (DALY) for CVD is significantly higher than the global average [2]; women in this region have the highest risk of cardiometabolic diseases globally, while men are second among men worldwide [3]. In Iran, CVD is the leading cause of death, accounting for 43% of deaths [4, 5] and ageing is expected to increase the DALY for CVD by more than double by 2025 compared to 2005 [6]. According to the results of the Global Burden of Disease Study in 2021, cardiovascular disease, after respiratory infections mainly due to COVID-19, was the second leading cause of death and disability in Iran with 4367 DALYs per 100,000 population in all ages [7].

The World Health Organization (WHO) recommends the Package of Essential Non-communicable Diseases (WHO-PEN) interventions including cardiovascular risk management, in primary health care. Iran has implemented the IraPEN, adapted from the WHO-PEN program, as a part of the National Health Transformation Program, which was launched in 2014 to provide global health coverage providing access to prevention and care for non-communicable diseases (NCDs) such as public education and integration of diabetes and hypertension in the health network system. This program was piloted in four regions and is now being scaled up nationally in at least one district per province [8]. This study aims to evaluate the changes in risk factors and CVD risk one year after implementing the IraPEN program in the pilot areas.

Methods

Study population

In IraPEN, individuals aged 30 years and older were called by local health centers for screening of cardiometabolic risk factors and CVD risk assessment. The CVD risk assessment was done for people 40 years and older and 30鈥40 years old with at least one risk factor. Patients with physician-approved CVD were excluded from risk assessment, as they are already at a CVD risk of 30% or higher. In the current study, we used data from the Ministry of Health鈥檚 IraPEN Program in the pilot phase during 2016鈥2018 in four cities Naghadeh from West Azerbaijan Province, Maragheh from East Azerbaijan Province, Shahreza from Isfahan Province and Baft from Kerman Province. Initially, the sample size was 160,223 people, of which 25,764 persons were followed for at least one year (Fig.听1). The number of visits varied from two to fourteen times during one year of follow-up.

Fig. 1
figure 1

The Flowchart of the participant selection process in the current study

IraPEN program

The IraPEN program was developed based on the WHO-PEN program and aligned with existing national non-communicable disease (NCD) programs. In this program, the CVD risk assessment is conducted for the target group comprising individuals aged 30 years and above with at least one of the following risk factors: diabetes or high blood pressure history, waist circumference鈥夆墺鈥90听cm, smoking or alcohol consumption, family history of diabetes, kidney disease, or premature cardiovascular events and age 40 years and above [9].

For the current data, the target population鈥檚 waist circumference, blood pressure, and smoking status were examined by a health worker and blood sugar, and blood cholesterol levels were measured using point-of-care instruments. High blood sugar was confirmed by laboratory measurement. The 10-year risk of CVD (i.e. fatal or non-fatal coronary heart disease and stroke) was calculated based on the WHO/ISH risk assessment chart of the Eastern Mediterranean region B and using variables of age, sex, smoking, systolic blood pressure, diabetes, and total blood cholesterol. Individuals were then categorized into one of four risk groups: low risk (<鈥10%), medium risk (10 to <鈥20%), high risk (20 to <鈥30%), and very high risk (鈮モ30%). Follow-up care and repeated risk assessment were conducted annually for low-risk individuals, every 9 months for medium-risk individuals, every 6 months for high-risk individuals, and every 3 months for very high-risk individuals [10].

The appropriate interventions, including lifestyle modifications, drug treatments, and referrals to the secondary prevention level, are considered according to individuals鈥 risk factors and their level of 10-year CVD risk, as specified in Table听1. It is noteworthy that the 10-year CVD risk assessment and management is performed at the first level of service provision by a health worker (Behvarz) through integrated care of diabetes, hypertension, hyperlipidemia, and obesity. The Behvarz health worker plays a central role in delivering health services to the target community, as well as recording and following up on patient care. They typically possess a background in health sciences and receive specialized training in non-communicable disease management, which enables them to conduct screenings and provide health education. Behvarz are trained to deliver basic medical care, manage common illnesses, and refer patients to higher-level healthcare facilities when necessary. They serve as a vital link between the healthcare system and the community, ensuring that health services are accessible and culturally appropriate.

Table 1 A summary of intervention in IraPEN program

Individuals assessed for CVD risk receive a risk card and training on a healthy diet, adequate physical activity, non-smoking, and no alcohol consumption. The card contains the individual鈥檚 risk assessment and the necessary actions for follow-up. All individual measurements, actions taken, and required follow-ups are recorded and tracked in the 鈥淪IB鈥 online health information system. SIB (System for Integrated Health Information) is an online platform utilized in Iran for tracking patient data and managing health interventions. This system records data from the Ministry of Health and captures services related to the IraPEN program.

Statistical analysis

To assess changes in risk factors and CVD risk scores over time, we compared these variables at the first visit and one year later. We used paired t-tests to compare continuous variables and McNemar tests to compare categorical variables. We also used Generalized Estimation Equations (GEE) to assess the trend of changes in risk factors and CVD risk over multiple visits. We used the identity link function for continuous risk factors and the logit link function for binary risk factors. The autoregressive working correlation structures were used to consider the correlation between the repetitions of some individuals in different exams. All GEE models were adjusted for age, sex, CVD risk score at the first visit (baseline), interactions of the visit with sex, and visit with CVD risk score. The number of visits during the one-year follow-up ranged from two to fourteen. Given the limited number of participants with four or more visits, only the first three visits were included in the analysis; thus, the GEE analysis was restricted to the first, second, and third visits.

The IraPEN program assessed the 10-year cardiovascular disease (CVD) risk using the WHO/ISH risk chart for the Eastern Mediterranean B region. The CVD risk category was determined and recorded for each individual at healthcare centers using this risk chart. Additionally, we calculated individuals鈥 risks using their recorded risk factors utilizing the revised WHO CVD risk models, as a post-hoc analysis [11]. The revised WHO CVD risk models have been validated in an Iranian population-based cohort study (Tehran Lipid and Glucose Study, TLGS) as the external validity of the original model [11]. In current study we applied the model calibrated for North Africa and Middle East and the CVD risk was computed using 鈥渨hocvdrisk鈥 command in STATA software. We used STATA version 14 to perform all statistical analyses and considered p鈥<鈥0.05 as statistically significant.

Results

Baseline characteristics

Table听2 shows the baseline characteristics of the 160,223 participants in the men and women groups for various variables. The mean age was 47.67 (13.64) years for men and 46.86 (12.97) years for women. Smoking was more prevalent in men than in women (13.18% vs. 0.57%, p鈥<鈥0.001), while central obesity and general obesity were more prevalent in women (57.26% vs. 50.90%, and 34.67% vs. 15.08%, respectively; both p鈥&濒迟;鈥0.001). Hypercholesterolemia was also more prevalent in women than in men (15.77% vs. 9.11%, p鈥&濒迟;鈥0.001).

Table 2 Baseline characteristics of the participants by sex (IraPEN, 2016鈥夆垝鈥2017)

Regarding diabetes, women had a higher prevalence than men (12.91% vs. 8.55%, p鈥<鈥0.001), especially in the known diabetes category (8.77% vs. 5.40%, for known diabetes and 4.14% vs. 3.15%, for unknown ones). Similarly, women had a higher prevalence of hypertension in total (23.19% vs. 15.62%, p鈥<鈥0.001), and known cases (18.23% vs. 9.49%, p鈥<鈥0.001), but a lower prevalence in unknown cases (4.96% vs. 6.13%, p鈥&濒迟;鈥0.001).

The group that participated and followed in the program exhibited a higher prevalence of cardiovascular risk factors and a greater CVD risk compared to the group that did not participate (Supplementary Table 1). The average CVD risk for men was 0.104 among those who were followed, compared to 0.075 for those who were not followed. For women, these values were 0.0803 and 0.065, respectively.

One year after the start of the IraPEN program

Regarding the risk factors, the mean systolic and diastolic blood pressure decreased by around 2 mmHg in both men and women after the intervention. Additionally, mean fasting blood sugar and total cholesterol levels were modestly reduced in both men and women. However, the intervention did not affect mean waist circumference in either sex, and only men showed a significant decrease in mean BMI by only 0.1听kg/m2. Smoking decreased from 13.8 to 10.5% in men. (p鈥<鈥0.001 for all differences mentioned). The detailed results are shown in Table听3.

Table 3 Risk factors of cardiovascular disease in men and women before and one year after the intervention

The proportion of individuals with a CVD risk score above 10%, assessed by the WHO/ISH risk chart, decreased from 7.5% and 6.1鈥5.3% and 4.7% for men and women respectively (Supplementary Table 2). Additionally, based on the WHO revised model, this proportion declined from 34.3 to 32.2% for men and from 27.07 to 24.84% for women and the mean CVD risk for those with a risk score above 10% decreased from 0.198 to 0.177 in men and from 0.119 to 0.109 in women (P鈥&濒迟;鈥0.001).

The results of the Generalized Estimating Equations (GEE) analysis are presented in Fig.听2. The mean BMI was consistently higher among women compared to men throughout follow-up visits, with a slight decrease observed in men during visit 3. The rate of smoking was very low among women during all visits and decreased over visits 2 and 3 among men (P interaction鈥=鈥0.015). The trend of other risk factors was decreasing with negligible differences between men and women. The CVD risk score also reduced almost similarly in both sexes over visits.

Fig. 2
figure 2

Trends of CVD risk and risk factors among participants with 2 to 3 visits

Discussion

IraPEN as a national program has combined previous programs for the prevention and control of NCDs in the country with the WHO PEN program. This is the first report on the changes in risk factors and CVD risk during one year after implementing the IraPEN in pilot areas. We showed that the CVD risk score and most of its risk factors decreased modestly within one year in both sexes.

In the pilot areas, at baseline, the percentage of high-risk people with a CVD risk above 10% was 7.5% in men and 6% in women based on previous WHO/ISH risk charts; these values were 34.3% and 27.07% in men and women respectively based on the newly revised WHO CVD risk model. It seems that the previous WHO model is less sensitive compared to the new one and other well-known prediction models [12,13,14]. We recently in an Iranian national representative population showed that in 2016, based on the WHO revised model, 32% of men and 26% of women had a CVD risk above 10%, the results which are in line of the present study [15]. Also, the findings are in agreement with the results of studies that evaluated the WHO-PEN program and used the WHO/ISH chart to predict CVD risk [16,17,18] .

Our study showed that the absolute risk of CVD decreased by around 1鈥2% over one year after the beginning of IraPEN. It is important to clarify that while the absolute numbers in the risk category of >鈥30% (based on WHO/ISH risk charts) increased (from 6 to 12 for men and from 9 to 24 for women), this change is just around 0.1% (0.001) of total population and the overall proportion of individuals with a CVD risk score above 10% decreased significantly (from 7.5 to 5.3% for men and from 6.1 to 4.7% for women). On the other hand, the validity of WHO/ISH is questionable, but the revised WHO risk model has been validated in the Iranian large population-based cohort study of TLGS as an external validity of the original model [11]. Using this model, we observed a decrease in mean CVD risk, from 0.198 to 0.177 for men and from 0.119 to 0.109 for women.

This finding is in agreement with the study of Carma Karam et al. in France, which over 6-year interventions such as referring high-risk people to hospitals, referring people with low and medium risk to general practitioners, as well as interviewing people about nutrition and smoking cessation led to decrease in the 10-year risk for CVD, calculated by the Framingham model, from 13.3 to 11.7% in men and from 8 to 5.9% in women over the years 2007 to 2012 [19].

In the study of Aye et al., who examined the pilot implementation of the PEN program in Myanmar, the CVD risk category changed to lower risk categories just in a quarter of population after three followed up visits [20]. Also, in the study by Hyon et al. on the PEN program in North Korea, the results indicated that the interventions led to a significant reduction in the percentage of individuals in the high-risk category (risk鈥夆墺鈥20%), decreasing from 9.5 to 3% over a period of one year [17]. The study of Wangchuk et al., which evaluated the performance of the PEN program in Bhutan, showed that after the interventions and after 3 visits, the absolute 10-year risk of CVD was reduced from 13 to 7.3% [18].

We also showed that mean systolic blood pressure, diastolic blood pressure, blood cholesterol, and fasting blood sugar decreased in both sexes. Still, there was insufficient evidence regarding any change in waist circumference and BMI. In the case of smoking, there was also a slight decrease during the year after the start of the study; of note, the prevalence of smoking is generaly very low in Iranian women (0.6鈥9.8%) attributed to cultural norms and its stigma [21]. These findings are in agreement with some previous studies that have shown a decreasing trend in most of the risk factors of cardiovascular diseases [19, 22]. The study of Aye et al. in Myanmar showed a reduction in CVD risk score, blood sugar and systolic blood pressure among 26%, 60% and 31% of cases after a year of intervention [20]. Also, in the study of Hyon et al. in North Korea, the results showed a significant reduction had occurred in the categories of CVD risk of (i) 20鈥30% and (ii)鈥夆墺鈥30% from (i) 587 (25.3%) to 306 (13.2%) and (ii) 395 (17%) to 176 (7.6%) respectively between the first and third visit [17]. The study by Wangchuk et al., which evaluated the performance of the PEN program in a 3-month period in Bhutan, showed that after 3 visits, the use of antihypertensive and antidiabetic drugs in people with diabetes and high blood pressure increased [18]. The study by Malekzadeh et al., which examined the trend of cardiovascular disease risk factors in diabetic patients versus the general population during the last decade in Iran, showed that in people with diabetes, compared to people without diabetes, the average systolic blood pressure, diastolic blood pressure and non-HDL cholesterol were reduced more predominantly. Also, fasting plasma glucose decreased in people with diabetes but increased in people without diabetes. So, it can be concluded that some of this reduction of risk factors can be attributed to population interventions in health centers and national programs to control diabetes and hypertension [23].

As mentioned, waist circumference and BMI did not change significantly in the present study, which seems to be more difficult to control than other risk factors such as high blood pressure, high blood sugar, and high blood fat. It seems that even controlling other risk factors without controlling obesity is valuable because overweight and obese individuals who are metabolically healthy have a lower risk of cardiovascular disease complications [24,25,26].

The national diabetes prevention and control program has been implemented since 1999 in Iran. The goal of this program was primary, secondary and tertiary prevention through screening of high-risk populations and integration of diabetes care into the primary health care network [27]. Following that, in 2015, Iran鈥檚 Ministry of Health established the Iran Non-Communicable Diseases Committee (INCDC) to deal with the high burden of NCDs. In line with WHO鈥檚 global action plan, INCDC prepared the 鈥淣ational Action Plan for the Prevention and Control of Noncommunicable Diseases and Related Risk Factors in Iran from 2015鈥2025鈥, which was then revised to cover up to 2030 [28]. In continuation of the program of structural transformation in the health system, the IraPEN program was designed in 2015 and implemented in four cities [29].

Farzadfar et al. conducted a study in Iran to investigate the effectiveness of diabetes and blood pressure management by rural primary healthcare workers (Behvarz). The study showed that the primary healthcare system, a sufficient number of health personnel, and a program with well-defined guidelines and individual patient follow-up can effectively manage chronic disorders such as diabetes. They conclude that management of NCDs in a primary health care system, especially in rural areas, through a system of trained community health care personnel who are trained and adhere to national treatment guidelines is an approach that may be more feasible and economical than training and hiring many doctors [30]. This evidence suggests that if the facilities and planning are provided properly, the implementation of projects like IraPEN by Behvarz and healthcare workers can be successful to a large extent.

Finally, we observed that people with a high risk of CVD were followed and people with low risk were not followed, and the visible effects are the result of the interventions made in high-risk people, which is consistent with the findings of studies conducted in high-risk people [31,32,33]. By utilizing risk scoring methods, healthcare providers can prioritize individuals based on their CVD risk levels, ensuring that those at the highest risk receive timely and appropriate preventive measures. Recently we measured the potential cost-effectiveness of IraPEN preventive actions for CVD in a modelling study. Based on the WHO CVD risk chart, four index cohorts were constructed as low (<鈥10%), moderate (10鈥19%), high (20鈥29%), and very high-risk (鈥>鈥=鈥30%). The results show that the intervention can yield an incremental cost-effectiveness ratio (ICER) of $804, $551, and -$44 per QALY for moderate, high, and very high CVD risk in non-diabetic groups, respectively. The results demonstrated an ICER of $711, $630, -$42, and -$71 for low, moderate, high, and very high-risk groups with diabetes, respectively. The IraPEN program could be highly cost-effective for all CVD risk groups in the non-diabetic individuals except the low-risk group [34]. So, using non-laboratory office-based CVD risk scores as the first step of screening to select high-risk groups for further evaluation can improve the cost-effectiveness of the program [11, 35]. Although we have previously validated and/or recalibrated different well-known CVD risk scores for the Iranian population [36,37,38,39], in the current study we used the revised WHO CVD risk score which is currently applied in primary healthcare in Iran; this risk score has also been validated in an Iranian population, Tehran Lipid and Glucose Study, as the external validity of the original model [11].

The present study has several strengths, including that our study is a population-based study using real data and a large sample size. In addition, it is the first nationwide study to evaluate the IraPEN program. Our study had some limitations that need to be mentioned. First, this is a before-and-after study, and there was no control group. Second, we acknowledge that only 16% of eligible individuals participated in the IraPEN pilot program, which raises concerns about the generalizability of our findings. The low participation rate can be attributed to several factors, including limited awareness of the program鈥攇iven its status as a pilot initiative鈥攄ependence on the private sector for referrals, and prevailing cultural attitudes towards health interventions. Despite the low percentage of eligible participants, our analysis focused on those who actively engaged in the program, similar to a per-protocol analysis in clinical trials, and it is not clear how effective the program would have been if it had been a regular program. Third, we were able to examine only one year after the program鈥檚 implementation, which may be a short period to measure more variations in some risk factors and the effectiveness of the IraPEN program.

Conclusions

In conclusion, the IraPEN program was modestly effective in reducing CVD risk and associated risk factors in the pilot areas of Iran. However, further modifications may be necessary to enhance the program鈥檚 effectiveness. For instance, implementing non-laboratory CVD risk scores as an initial screening and self-assessment tool, along with expanding the training scope for healthcare workers and the general population could be beneficial. The study highlights the importance of primary healthcare systems and trained community healthcare personnel in managing chronic disorders such as CVD. Future research could explore the long-term effectiveness of the IraPEN program and its scalability to other regions in Iran. Overall, the study provides valuable insights into the effectiveness of the IraPEN program in reducing CVD risk and associated risk factors, and its potential to improve the health outcomes of individuals in Iran and other similar settings.

Data availability

The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.

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Acknowledgements

The authors are grateful to the NCD office in the Ministry of Health for providing the opportunity to do this study and making the data available.

Funding

This research supported by the Research Institute for Endocrine Sciences and did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

Authors

Contributions

鈥淪D, DKH, KE designed the study and supervised data collection.SD, DKH, AM, S.SH, AK analyzed the data, interpreted the results , and drafted the manuscript.FH and AO participated in data collection.All authors have approved the submitted versions. All authors read and approved the final manuscript.鈥

Corresponding authors

Correspondence to Afshin Ostovar or Koorosh Etemad.

Ethics declarations

Ethics approval and consent to participate

IraPEN is a national program approved and delivered by the Ministry of Health and Medical Education that did not require informed consent from participants. We adhered to the ethical standards set by the Institutional Review Board of Shahid Beheshti University of Medical Sciences, which approved the study protocol under ethics committee code IR.SBMU.ENDOCRINE.REC.1401.003.

Competing interests

KE, AO and AM have been among the supervisors of IraPEN program and all authors declare that they have no conflict of interest.

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Derakhshan, S., Khalili, D., Mahdavi, A. et al. Evaluation of the effectiveness of the Iran-package of essential non-communicable disease (IraPEN) program in reducing cardiovascular disease risk in pilot areas. 樱花视频 25, 429 (2025). https://doi.org/10.1186/s12889-024-21168-3

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  • DOI: https://doi.org/10.1186/s12889-024-21168-3

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