Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

BACKGROUND: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting. METHODS: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect. RESULTS: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups. CONCLUSIONS: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level. TRIAL REGISTRATION NUMBER: NCT03459560.

Prevalence of metabolically healthy obesity and healthy overweight and the associated factors in southern Iran: A population-based cross-sectional study.

Background and Aims: Obesity is considered a major growing threat to public health which could negatively affect the quality of life. The current cross-sectional study was conducted to investigate the population-based prevalence of metabolically healthy obesity (MHO) and healthy overweight (MHOW) and associated factors in southern Iran. Methods: Baseline data from the Pars Cohort Study was analyzed. Metabolically healthy participants were identified based on the definition of the American Heart Association for the metabolic syndrome. The prevalence of MHOW and MHO and their 95% confidence intervals were estimated. Poisson regression was applied for the calculation of prevalence ratios (PRs). Results: Gender- and age-standardized prevalences of MHOW and MHO were 6.3% (6.0%-6.6%) and 2.3% (2.1%-2.5%), respectively. The following factors were associated with being MHOW compared with those with normal weight: Being younger, female gender (1.31, 1.20-1.43), higher socioeconomic status, being noncurrent cigarette smoker (1.27, 1.11-1.45), low level of physical activity (1.14, 1.03-1.25), having normal overweight during adolescence, and overweight (1.35, 1.24-1.48) or obesity (1.68, 1.53-1.86) during young adulthood. We also found strong associations between MHO and younger age groups, female gender (2.87, 2.40-3.42), being married (1.57, 1.08-2.27), Fars ethnicity (1.25, 1.10-1.43), higher socioeconomic status, ever use of tobacco (1.14, 1.00-1.30), never use of opium (1.85, 1.19-2.86), lower physical activity (1.45, 1.20-1.72), being normal weight in 15-year body pictogram and being overweight (1.87, 1.59-2.20) or obese (3.20, 2.74-3.72) in 30-year body pictogram when considering those with normal weight or MHO. Conclusion: Potentially modifiable factors including physical activity should be more emphasized. Furthermore, our study issued that it would be more reasonable that the prevention of unhealthy obesity be initiated before the development of MHO, where there are more protective factors and they could be more effective.

Polypharmacy and pattern of medication use among patients with gastroesophageal reflux disease: results from Pars Cohort study.

BACKGROUND: Gastroesophageal Reflux Disease (GERD) is a common chronic condition. Its chronic nature may affect the pattern of medication use. This study aimed to investigate the prevalence, associated factors, and patterns of polypharmacy and medication use among GERD patients in southwestern Iran. METHODS: We used data from the Pars Cohort Study. We classified drugs using the Anatomical Therapeutic Chemical classification system. The Lexicomp® database was used to assess potential drug-drug interactions. Multivariable Poisson regression was applied. Adjusted prevalence ratio (PR) and its 95% confidence interval (CI) were estimated. RESULTS: A total of 9262 participants were included. Among 2,325 patients with GERD, age-standardized prevalence of polypharmacy was 9.5% (95% CI: 7.5%, 11.6%) in males, and 19.3% (95% CI: 17.2%, 21.4%) in females. The PR of experiencing Polypharmacy by GERD patients compared to non-GERD patients was 1.82 (95% CI: 1.61, 2.05%). Multimorbidity (PR: 3.33; CI: 2.66, 4.15), gender (PR: 1.68; CI: 1.30, 2.18), and metabolic syndrome (PR: 1.77; CI: 1.45, 2.15) were associated with polypharmacy among GERD patients. Drugs for acid-related disorders were the most common used drugs among men, women and elders. We found that 13.9%, 4.2%, and 1.1% of GERD patients had type C, D and X drug interactions, respectively. CONCLUSION: GERD is correlated with a higher prevalence of polypharmacy. Among GERD patients, females, those with multi-morbidities, and those with metabolic syndrome may be affected more by polypharmacy. Considering the fairly high rate of interactions identified, a review of the medication list is essential when approaching GERD patients, and physicians must check for medications that may worsen GERD.

Liver fibrosis in pars cohort study: A large-scale study on the prevalence and correlated factors.

BACKGROUNDS AND STUDY AIMS: The fibrosis-4 (FIB-4) is a non-invasive scoring system for estimating liver fibrosis severity as a biomarker of chronic liver disease. We aimed to estimate the prevalence and severity of chronic liver disease at the community level using FIB-4. PATIENTS AND METHODS: This cross-sectional study was conducted using the Pars Cohort database collected in Valashar, Fars province, Iran. Participants were divided into three groups based on their FIB-4 scores: low risk of liver fibrosis (FIB < 1.45), intermediate cases (1.45 ≤ FIB-4 ≤ 3.25), and high risk of liver fibrosis (FIB-4 > 3.25). RESULTS: In total, 9269 individuals with a mean age of 52.65 years were enrolled in the study, of which 4278 (46.2 %) were male. Among all participants, 7853 (84.7 %) were in the low-risk, and 65 (0.7 %) were in the high-risk groups. In the final ordinal regression model, male gender, being a farmer or rancher, living in rural areas, history of opioid use, history of jaundice, no history of diabetes, history of depression, and positive HBs Ag were independently associated with higher FIB-4 scores. CONCLUSION: Our study revealed that males, individuals residing in rural areas, and those engaged in farming and ranching occupations face a heightened risk of liver fibrosis. These findings emphasize the need for future programs for early detection and effective management of liver fibrosis in these at-risk populations.

Population-based pattern of medication use and prevalence of polypharmacy among patients with cardiovascular diseases: results of the Pars cohort study from Iran.

BACKGROUND: Polypharmacy in patients with cardiovascular diseases (CVDs) has been linked to several adverse outcomes. This study aimed to investigate the pattern of medication use and prevalence of polypharmacy among CVDs patients in Iran. METHOD: We used the baseline data of the Pars cohort study (PCS). The participants were asked to bring their medication bags; then, the medications were classified using the Anatomical Therapeutic Chemical classification. Polypharmacy was defined as using five or more medications concurrently. Poisson regression modeling was applied. The adjusted prevalence ratios (PR) and its 95% confidence interval (CI) were estimated. RESULTS: Totally, 9262 participants were enrolled in the PCS, of whom 961 had CVDs. The prevalence of polypharmacy in participants with and without CVDs was 38.9% and 7.1%, respectively. The highest prevalence of polypharmacy (51.5%) was among obese patients. Abnormal waist-hip ratio (PR: 2.79; 95% CI 1.57-4.94), high socioeconomic status (PR: 1.65; 95% CI 1.07-2.54), tobacco-smoking (PR: 1.35; 95% CI 1.00-1.81), patients with more than three co-morbidities (PR: 1.41; 95% CI 1.30-1.53), high physical activity (PR: 0.66; 95% CI 0.45-0.95), use of opiate ever (PR: 0.46; 95% CI 0.26-0.82), and healthy overweight subjects (PR: 0.22; 95% CI 0.12-0.39) were associated with polypharmacy. Cardiovascular drugs (76.1%), drugs acting on blood and blood-forming organs (50.4%), and alimentary tract and metabolism drugs (33.9%) were the most frequently used drugs. Agents acting on the renin-angiotensin system were the mostly used cardiovascular system drugs among men and those above 60 years old, while beta-blocking agents were mostly prevalent among cardiovascular system drugs in women with CVDs. CONCLUSION: Given the high prevalence of polypharmacy among CVDs patients, and subsequent complications, programs to educate both physicians and patients to prevent this issue is crucial.

Pictogram Is a Valid Instrument to Classify At-Risk Adult Population Based on Abdominal Obesity: Results from Pars Cohort Study.

BACKGROUND: Abdominal obesity is associated with increased risk of myocardial infarction and death events. Thus, obtaining data on the status of abdominal obesity is important in risk factor assessment and prevention of non-communicable diseases. This study aimed to evaluate the validity of using pictograms to classify abdominal obesity indices (waist circumference [WC], waist-hip ratio [WHR], and waist-height ratio [WHtR]) into normal and at-risk categories and determine the effects of demographic characteristics on this validity. METHODS: This cross-sectional study used data from Pars Cohort Study (PCS). Participants chose the most similar pictogram scores to their body size at 15, 30 years, and current age. Optimal normal/at-risk cut-off values for pictograms were calculated using sensitivity/specificity plots. Receiver operating characteristic curves were used to evaluate the validity of pictograms. Validity measures were analyzed across different subgroups of demographic characteristics. RESULTS: A total of 9263 participants (46% males) were included in the study. The estimated area under the curves were 84% for WC, 77% for WHR, and 89% for WHtR in males, and 84% for WC, 73% for WHR, and 90% for WHtR in females. Optimal pictogram cutoffs to classify central obesity for WC, WHR, and WHtR were 4, 4, and 5 in males and 4, 4, and 6 in females, respectively. The majority of demographic characteristics were not associated with the validity of pictograms. CONCLUSION: Using pictograms to determine normal and at-risk categories of abdominal obesity indices is valid among adult population with a wide range of demographic characteristics. However, the results need to be interpreted with caution in those with a positive history of weight fluctuation.

Comparison of laboratory-based and non-laboratory-based WHO cardiovascular disease risk charts: a population-based study.

BACKGROUND: Determining the risk of Cardiovascular Disease (CVD) is a necessity for timely preventive interventions in high-risk groups. However, laboratory testing may be impractical in countries with limited resources. This study aimed at comparison and assessment of the agreement between laboratory-based and non-laboratory-based WHO risk charts models. METHODS: This study was performed using the baseline data of 8138 participants in the pars cohort study who had no history of CVD and stroke. The updated 2019 WHO model was used to determine the 10-year fatal and non-fatal CVD risks. In general, there are two types of new WHO risk prediction models for CVD. The scores were determined based on age, sex, smoking status, diabetes, Systolic Blood Pressure (SBP), and total cholesterol for the laboratory-based model and age, sex, smoking status, SBP, and Body Mass Index (BMI) for the non-laboratory-based model. The agreement of these two models was determined via kappa statistics for the classified risk (low: < 10%, moderate: 10-< 20%, high: ≥ 20%). Correlation coefficients (r) and scatter plots was used for correlation between scores. RESULTS: The results revealed very strong correlation coefficients for all sex and age groups (r = 0.84 for males < 60 years old, 0.93 for males ≥ 60 years old, 0.85 for females < 60 years old, and 0.88 for females ≥ 60 years old). In the laboratory-based model, low, moderate, and high risks were 76.10%, 18.17%, and 5.73%, respectively. These measures were respectively obtained as 77.00%, 18.08%, and 4.92% in the non-laboratory-based model. Based on risk classification, the agreement was substantial for males < 60 years old and for both males and females aged ≥ 60 years (kappa values: 0.79 for males < 60 years old, 0.65 for males ≥ 60 years old, and 0.66 for females ≥ 60 years old) and moderate for females < 60 years old (kappa = 0.46). CONCLUSIONS: The non-laboratory-based risk prediction model, which is simple, inexpensive, and non-invasive, classifies individuals almost identically to the laboratory-based model. Therefore, in countries with limited resources, these two models can be used interchangeably.

The pattern of medication use, and determinants of the prevalence of polypharmacy among patients with a recent history of depressive disorder: results from the pars cohort study.

BACKGROUND: Inappropriate medication use among individuals with depressive disorders (DD) is a rising public health challenge. We aimed to investigate the polypharmacy and its determinants among individuals with DD in a less developed region, and evaluate the pattern of medication use in this population. METHODS: Data was extracted from Pars Cohort Study (PCS) between 2016 and 2019. Participants were asked to bring all the medication they were using regularly, and history of DD during the last 12 months prior to study was obtained. The Anatomical Therapeutic Chemical classification was applied and polypharmacy was defined as concurrent use of five or more medications. Logistic regression models were developed to estimate the associations between polypharmacy and DD, adjusted for relevant covariates. The prevalence of consumption of each drug class was estimated among males, females, and elders. Logistic regression was applied and the adjusted odds ratio (OR) and its 95% confidence interval (CI) were estimated. RESULTS: A total of 9264 participants with a mean age of 52.6 (SD: 9.7) were enrolled. The prevalence of polypharmacy was 22.6% [95% CI (20.7-24.6)]. The most common drug classes were genitourinary system (55.4%) and nervous system (29.1%) medication, respectively. Recent history of DD was reported among 19.4% (n = 1795) participants, the majority of whom were females. Factors associated with polypharmacy include female gender (OR: 1.51), Fars ethnicity (OR: 1.52), lower physical activity (OR: 1.74), and higher socioeconomic status (OR: 1.40). The prevalence of antidepressant use among males was higher than females (P < 0.001). CONCLUSION: The prevalence of polypharmacy is high among patients with a recent history of depressive disorder. Females, individuals with higher socioeconomic status and lower physical activity, and those who use tobacco are more likely to be polymedicated. Surveillance measures need to be established to monitor the patterns of medication use among individuals with depressive disorders.

Validity of Body Image Pictogram to Determine Overweight/Obesity in Adults from Less Developed Populations: Results From Pars Cohort Study.

BACKGROUND: Despite the evidence for validity of body image pictogram (BIP) to discriminate overweight, obese, and normal individuals, there is little evidence on the probable effect of socio-demographic variables on its validity. To investigate the effects of socioeconomic status (SES), age, ethnicity, and educational level on the validity of BIP to discriminate normal weight, overweight, and obese people. METHODS: We used the Pars Cohort Study (PCS) data. Stunkard's BIP score was used as test measure. Participants were classified as normal (body mass index [BMI]<25), overweight (BMI=25 to 29.9), and obese (BMI≥29.9) based on their BMI (kg/m2 ). Area under curve (AUC) and its 95% CI were estimated and compared. Optimal cutoff points and their sensitivity, specificity, and likelihood ratio were reported. RESULTS: A total of 9232 participants with a female/male ratio of 1.03 were included. The prevalence of overweight and obesity was 37.4% and 18.2%, respectively. Regardless of socio-demographic levels, the optimal cut-points to discriminate normal BMI from overweight, and overweight from obese participants were BIP score of four and five, respectively. Estimated AUC correlated with ethnicity (P<0.001) for both genders, and with SES for females (P<0.05). CONCLUSION: Although BIP may be a valid measure to categorize the general adult population into normal, overweight and obese, its validity depends on SES and ethnicity. BIP may be available as a proxy measure for BMI categories in socio-demographically homogeneous populations but not in heterogeneous populations.

Prevalence of Hepatitis B and C Infections and Associated Risk Factors in Pars Cohort Study, Southern Iran.

BACKGROUND Hepatitis B and C virus (HBV and HCV) infections rank among the most frequent infectious diseases with a rising worldwide burden. However, their epidemiology and risk factors are understudied in many regions, including Iran. METHODS This study was conducted as part of the Pars Cohort Study (PCS) in Valashahr district, Fars province (2012-2014). Participants received venipuncture for HBsAg and HCV antibody, followed by Polymerase Chain Reaction (PCR) testing. All infected people and their comparison groups completed a risk assessment questionnaire. RESULTS Overall, 9,269 people participated in the study; the majority were women and of Fars ethnicity. Prevalence of HBsAg and HCV antibody was 2.3% (n = 215) and 0.3% (n = 26), from whom 23% (n = 47) and 13% (n = 3) had indications for treatment, respectively. During follow-up, among HBsAg-positive individuals who were not on treatment, 62% tested negative for HBsAg, and in 2% HBV DNA had risen to treatment levels. Risk factors for HBV infection were illiteracy [OR = 3.43, 95% CI = 1.1, 10.3], and Turk ethnicity compared to Fars [OR = 1.58, 95% CI = 1.1, 2.3]. History of blood transfusion [OR = 2.00, 95% CI = 1.1, 3.5] and history of drug use [OR = 2.85, 95% CI = 1.1, 7.4] were associated with HCV infection, after adjustment. CONCLUSION Further epidemiological studies are needed to identify at-risk populations in different regions. Preventive interventions, including educational programs and transfusion safety strategies, are crucial for reducing the hepatitis burden.

Correction: Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial.

This corrects the article "Effectiveness of polypill for prevention of cardiovascular disease (PolyPars): protocol of a randomized controlled trial" published on 2020: Volume 23, Issue 08, Pages 548-556. Correction to: Arch Iran Med. 2020;23(8):548-556. doi: 10.34172/aim.2020.58. In the original version of this article, the recruitment period was wrongly reported to last from December 2014 to December 2015 in abstract and methods sections of the article. This is corrected into "from December 2015 to December 2016" in the PDF and HTML versions of the article. Also the "PolyIran" is changed to "PolyPars" in the last paragraph of the discussion section in the PDF and HTML versions of the article.

Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial.

BACKGROUND: Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD. METHODS: The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up. RESULTS: From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560. CONCLUSION: Polypill may be effective for primary prevention of CVDs in developing countries.

Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial.

BACKGROUND: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. METHODS: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985. FINDINGS: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; pinteraction=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group. INTERPRETATION: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs. FUNDING: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou.

Prevalence, Awareness, Treatment, Control, and Correlates of Hypertension in the Pars Cohort Study.

BACKGROUND: High blood pressure is an important risk factor for all-cause mortality and cardiovascular mortality and morbidity among Iranians. We aimed to estimate its prevalence, correlates, and its rate of awareness, treatment, and control in South of Iran. METHODS: The Pars Cohort Study (PCS) was launched in a district of Fars province. All residents between 40 and 75 years old in the district were recruited from 2012 to 2014. Hypertension was defined as either systolic/diastolic blood pressure ≥ 140/90 mm Hg or taking medications. Logistic regression was used to identify the correlates of hypertension and awareness and its treatment and control. A total of 9264 participants were recruited. Of the total participants, 46.2% were men. The mean age was 52.6 years (SD: 9.7). RESULTS: Prevalence of hypertension was 26.9%. Of the total 2489 hypertensives, 49.6% were aware and 55.7% were under treatment. Blood pressure was controlled in 69.2% of treated hypertensives. In the adjusted model, female sex and history of cardiovascular disease (CVD) were positively associated with having hypertension, higher awareness, and better treatment and control. Older age, being overweight or obese, and having a history of diabetes were also positively associated with having hypertension and higher awareness and treatment; however, being overweight or obese was associated with poorer hypertension control. Older age and having a history of diabetes did not show a statistically significant association with control. CONCLUSION: Being underweight and higher physical activity were inversely associated with having hypertension but were not associated with awareness, treatment, or control. Prevalence of hypertension is high but the rates of awareness, treatment, and control are not adequate.

Reliability Analysis of a Newly Developed Questionnaire for Quality Control of Follow-up Visits in PolyIran Study.

BACKGROUND: The PolyIran study is a large-scale pragmatic cluster randomized controlled trial of fixed-dose combination therapy (Polypill) for prevention of cardiovascular diseases (CVD) in Iran. The PolyIran Quality Control Program (PIQCP) including a new questionnaire was developed to assess the quality of data collection during follow-up visits. The aim of this study was to assess the inter-rater reliability of PIQCP questionnaire. METHODS: The study was conducted in 26 (11%) randomly selected clusters (from a total of 236 PolyIran clusters). All participants within these 26 clusters were enrolled. The quality scores were measured according to the PIQCP guidelines by two independent raters. The intraclass correlation coefficients (ICC) were measured. In addition, the quality scores were categorized into good (70%) and poor (<70%). The kappa coefficient was used to assess inter-rater agreement for this categorical quality scores. RESULTS: A total number of 945 PolyIran participants were enrolled of which, 501 (53%) were from intervention arm. In 934 participants (98.8%), the quality score could be successfully identified by both raters. The ICC (95%CI) of the overall quality scores was 0.985 (0.983-0.987). It was 0.976 (0.972-0.980) and 0.988 (0.986-0.990) in intervention and control arms, respectively. We found excellent agreement between the two raters in identifying participants with good and poor quality scores (kappa = 0.988, P < 0.001). The kappa values were 0.972 (P < 0.001) and 1.000 (P < 0.001) in intervention and control arms, respectively. DISCUSSION: Our results suggested that the PIQCP questionnaire is a reliable tool for assessing quality of data collection in PolyIran follow-up visits. Using this measure will help us in efficient monitoring of the PolyIran follow-ups and may ensure high quality data.

Burden of Gastrointestinal and Liver Diseases in Middle East and North Africa: Results of Global Burden of Diseases Study from 1990 to 2010.

BACKGROUND Gastrointestinal and liver diseases (GILDs) are major causes of death and disability in Middle East and North Africa (MENA). However, they have different patterns in countries with various geographical, cultural, and socio-economic status. We aimed to compare the burden of GILDs in Iran with its neighboring countries using the results of the Global Burden of Disease (GBD) Study in 2010. METHODS Classic metrics of GBD have been used including: age-standardized rates (ASRs) of death, years of life lost due to premature death (YLL), years of life lost due to disability (YLD), and disability adjusted life years (DALY). All countries neighboring Iran have been selected. In addition, all other countries classified in the MENA region were included. Five major groups of gastrointestinal and hepatic diseases were studied including: infections of gastrointestinal tract, gastrointestinal and pancreatobilliary cancers, acute hepatitis, cirrhosis, and other digestive diseases. RESULTS The overall burden of GILDs is highest in Afghanistan, Pakistan, and Egypt. Diarrheal diseases have been replaced by gastrointestinal cancers and cirrhosis in most countries in the region. However, in a number of countries including Afghanistan, Pakistan, Turkmenistan, Egypt, and Yemen, communicable GILDs are still among top causes of mortality and morbidity in addition to non-communicable GILDs and cancers. These countries are experiencing the double burden. In Iran, burden caused by cancers of stomach and esophagus are considerably higher than other countries. Diseases that are mainly diagnosed in outpatient settings have not been captured by GBD. CONCLUSION Improving the infrastructure of health care system including cancer registries and electronic recording of outpatient care is a necessity for better surveillance of GILDs in MENA. In contrast to expensive treatment, prevention of most GILDs is feasible and inexpensive. The health care systems in the region can be strengthened for prevention and control.

Trend of Gastrointestinal and Liver Diseases in Iran: Results of the Global Burden of Disease Study, 2010.

BACKGROUND The general pattern of epidemiologic transition from communicable to noncommunicable diseases is also observed for gastrointestinal and liver diseases (GILD), which constitute a heterogeneous array of causes of death and disability. We aimed to describe the trend of GILD in Iran based on the global burden of disease (GBD2010) study from 1990 to 2010. METHODS The trend of number of deaths, disability, adjusted life years (DALYs) and their age-standardized rates caused by 5 major GILD have been reported. The change in the rankings of major causes of death and DALY has been described as well. RESULTS The age standardized rates of death and DALYs in both sexes have decreased from 1990 to 2010 for most GILD. The most prominent decreases in death rates are observed for diarrheal diseases, gastritis and duodenitis, and peptic ulcer disease. Positive trends are observed for liver cancer, pancreatic cancer, and gall bladder cancer. Diarrheal diseases have retained their 1st rank among children under 5. Among adults, decreased ranks are observed for diarrheal diseases, appendicitis, gastritis and duodenitis, gall bladder diseases, pancreatitis, and all types of cirrhosis. The trends in age standardized rates of DALYs, deaths, and YLLs are negative for almost all GILD, and especially for diarrheal diseases. However, there is no upward or downward trend in rates of years lost due to disability (YLDs) for most diseases. Total numbers of DALYs and deaths due to acute hepatitis C, stomach cancer, and liver cancers are rising. The total DALYs due to overall digestive diseases except cirrhosis and DALYs due to cirrhosis are both somehow stable. No data has been reported for GILD that are mainly diagnosed in outpatient settings, including gastroesophageal reflux disease, irritable bowel syndrome, and non-alcoholic fatty liver disease. CONCLUSION The results of GBD 2010 demonstrate that the rates of most GILD are decreasing in Iran but total DALYs are somehow stable. However, as diseases detected in outpatient settings have not been captured, the burden of GILD seems to be underestimated. Population-based studies at national level are required for accurate reports.

Burden of Gastrointestinal and Liver Diseases in Iran: Estimates Based on the Global Burden of Disease, Injuries, and Risk Factors Study, 2010.

BACKGROUND Gastrointestinal and liver diseases (GILD) constitute a noteworthy portion of causes of death and disability in Iran. However, data on their prevalence and burden is sparse in Iran. The Global Burden of Disease (GBD) study in 2010 has provided invaluable comprehensive data on the burden of GILD in Iran. METHODS Estimations of death, years of life lost due to premature death (YLL), years of life lost due to disability (YLD), disability-adjusted life years (DALY), life expectancy, and healthy life expectancy have been reported for 291 diseases, 67 risk factors, 1160 sequelae, for both sexes and 19 age groups, form 1990 to 2010 for 187 countries. In the current paper, 5 major categories of gastrointestinal (GI) and liver diseases have been investigated as follows: GI infectious diseases, GI and liver cancers, liver infections, chronic end stage liver disease, and other digestive diseases. RESULTS Among women, 7.6% of all deaths and 3.9% of all DALYs were due to digestive and liver diseases in 2010. The respective figures in men were 7.8% of deaths and 4.6% of DALYs. The most important cause of death among children under 5 is diarrhea. Among adults between 15 to 49 years old, the main causes of death are GI and liver cancers and cirrhosis, while diarrhea still remains a major cause of DALY. Among adults 50 years and above, GI and liver cancers and cirrhosis are the main causes of both deaths and DALYs. Gastritis and duodenitis, diarrheal diseases, gall bladder and bile duct diseases, acute hepatitis A, peptic ulcer disease, appendicitis, and acute hepatitis A mainly cause disability rather than death. CONCLUSION GBD study provides invaluable source of data on burden of GILD in Iran. However, there exist limitations, namely overestimation of burden of liver cancer and underestimation of the burden of GI diseases that are usually diagnosed in outpatient settings. The collaboration of scientists across the world and specifically those from developing countries is necessary for improving the accuracy of future updates of GBD in these countries.

The clinical performance of an office-based risk scoring system for fatal cardiovascular diseases in North-East of Iran.

BACKGROUND: Cardiovascular diseases (CVD) are becoming major causes of death in developing countries. Risk scoring systems for CVD are needed to prioritize allocation of limited resources. Most of these risk score algorithms have been based on a long array of risk factors including blood markers of lipids. However, risk scoring systems that solely use office-based data, not including laboratory markers, may be advantageous. In the current analysis, we validated the office-based Framingham risk scoring system in Iran. METHODS: The study used data from the Golestan Cohort in North-East of Iran. The following risk factors were used in the development of the risk scoring method: sex, age, body mass index, systolic blood pressure, hypertension treatment, current smoking, and diabetes. Cardiovascular risk functions for prediction of 10-year risk of fatal CVDs were developed. RESULTS: A total of 46,674 participants free of CVD at baseline were included. Predictive value of estimated risks was examined. The resulting Area Under the ROC Curve (AUC) was 0.774 (95% CI: 0.762-0.787) in all participants, 0.772 (95% CI: 0.753-0.791) in women, and 0.763 (95% CI: 0.747-0.779) in men. AUC was higher in urban areas (0.790, 95% CI: 0.766-0.815). The predicted and observed risks of fatal CVD were similar in women. However, in men, predicted probabilities were higher than observed. CONCLUSION: The AUC in the current study is comparable to results of previous studies while lipid profile was replaced by body mass index to develop an office-based scoring system. This scoring algorithm is capable of discriminating individuals at high risk versus low risk of fatal CVD.

Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial.

BACKGROUND: The complexity of treatment regimens, costs and pill burden decrease the medication adherence and contribute to shortfall in cardiovascular preventive drug coverage. The polypill, a fixed dose combination pill of established drugs, is expected to increase adherence and reduce the costs whilst preventing major cardiovascular events (MCVE). DESIGN AND METHODS: The PolyIran trial is a pragmatic cluster randomized trial nested within the Golestan Cohort Study (GCS). Subjects were randomized to either non-pharmacological preventive interventions alone (minimal care arm) or together with a polypill (polypill arm) comprising hydrochlorothiazide, aspirin, atorvastatin and either enalapril or valsartan. This study benefits from the infrastructure of the primary health care system in Iran and the interventions are delivered by the local auxiliary health workers (Behvarz) to the participants. The primary outcome of the study is the occurrence of first MCVE within five years defined as non-fatal and fatal myocardial infarction, unstable angina, sudden death, heart failure, coronary artery revascularization procedures, and non-fatal and fatal stroke. TRIAL STATUS: From February 2011 to April 2013, 8410 individuals (236 clusters) attended the eligibility assessment. Of those, 3421 in the polypill arm and 3417 in the minimal care arm were eligible. The study is ongoing. CONCLUSION: The infrastructure of GCS and the primary health care system in Iran enabled the conduct of this pragmatic large-scale trial. If the polypill strategy proves effective, it may be implemented to prevent cardiovascular disease in developing countries.