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 and determinants of anemia among Iranian population aged ≥35 years: A PERSIAN cohort-based cross-sectional study.

BACKGROUND: So far, no comprehensive studies have been performed to assess burden and determinants of anemia in Iran. In the present study, we aimed to answer this query using the data obtained from the Prospective Epidemiological Research Studies in IrAN (PERSIAN). METHODS: In this cross-sectional study, we included 161,686 adult participants (aged 35 years and older) from 16 provinces of Iran. Anemia was defined as a hemoglobin concentration of <13 g/dL in males and <12 g/dL in females. To evaluate the association between anemia and different factors, we used the multivariable Poisson regression analysis with robust variance by applying adjusted prevalence ratio (PR) with 95% confidence interval (CI). RESULTS: Of the total number of subjects, 72,387 (44.77%) were male and others were female. Mean age was 49.39±9.15 years old. The overall age- and sex-standardized prevalence of anemia was 8.83% (95% CI: 8.70-8.96%) in the included population. The highest and the lowest age- and sex-standardized prevalence of anemia pertained to Hormozgan (37.41%, 95% CI: 35.97-38.85%) and Kurdistan (4.57%, 95% CI: 3.87-5.27%) provinces, respectively. Being female (PR = 2.97), rural residence (PR = 1.24), being retired (PR = 1.53) and housewife (PR = 1.11), third and fourth wealth status quartiles (PR = 1.09 and PR = 1.11, respectively), being underweight (PR = 1.49), drug user (PR = 1.35), inadequate sleep (PR = 1.16), poor physical activity (PR = 1.15), diabetes (PR = 1.09), renal failure (PR = 2.24), and cancer (PR = 1.35) were associated with increased risk of anemia. On the other hand, illiteracy (PR = 0.79) and abdominal obesity (PR = 0.77) decreased the risk of anemia. CONCLUSIONS: According to the results, a variable prevalence of anemia was observed across the included provinces. We tried to provide an informative report on anemia prevalence for health professionals and authorities to take measures for identification and management of the cases of anemia in high-prevalence areas.

Alarm of non-communicable disease in Iran: Kavar cohort profile, baseline and 18-month follow up results from a prospective population-based study in urban area.

The PERSIAN Kavar cohort study (PKCS) aims to investigate the prevalence, trends, and relevant prognostic risk factors of non-communicable diseases in participants aged 35-70 years living in the urban area of Kavar County. Kavar County is located at the center of Fars province in the southwest of Iran. Overall, 5236 adults aged 35-70 years old were invited to participate in the PKCS. From whom, 4997 people comprising 2419 men and 2578 women met the inclusion criteria and were recruited in the study (participation rate: 95.4%). This study is aimed to follow participants for at least 10 years; it is designed to perform all procedures similar to the primary phase including biological sampling, laboratory tests, physical examinations, and collecting general, nutritional, and medical data at the 5th and 10th years of follow-up. In addition, participants are annually followed-up by phone to acquire data on the history of hospitalization, any major diagnosis or death. At the enrollment phase, trained interviewers were responsible for obtaining general, nutritional, and medical data utilizing a 482-item questionnaire. The results of the baseline phase of this study show that the overweight category was the most prevalent BMI category among the registered participants (n = 2005, 40.14%). Also, almost one-third of Kavar adult population suffered from metabolic syndrome at the baseline phase (n = 1664, 33.30%). The rate of eighteen-month follow-up response was 100% in the PKCS. Hypertension (n = 116, 2.32%), cardiovascular outcomes (n = 33, 0.66%), and diabetes (n = 32, 0.64%) were the most prevalent new-onset NCDs during eighteen months of follow-up in the participants.

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.

Do clinical and paraclinical findings have the power to predict critical conditions of injured patients after traumatic injury resuscitation? Using data mining artificial intelligence.

PURPOSE: The triage and initial care of injured patients and a subsequent right level of care is paramount for an overall outcome after traumatic injury. Early recognition of patients is an important case of such decision-making with risk of worse prognosis. This article is to answer if clinical and paraclinical signs can predict the critical conditions of injured patients after traumatic injury resuscitation. METHODS: The study included 1107 trauma patients, 16 years and older. The patients were trauma victims of Levels I and II triage and admitted to the Rajaee (Emtiaz) Trauma Hospital, Shiraz, in 2014-2015. The cross-industry process for data mining methodology and modeling was used for assessing the best early clinical and paraclinical variables to predict the patients' prognosis. Five modeling methods including the support vector machine, K-nearest neighbor algorithms, Bagging and Adaboost, and the neural network were compared by some evaluation criteria. RESULTS: Learning algorithms can predict the deterioration of injured patients by monitoring the Bagging and SVM models with 99% accuracy. The most-fitted variables were Glasgow Coma Scale score, base deficit, and diastolic blood pressure especially after initial resuscitation in the algorithms for overall outcome predictions. CONCLUSION: Data mining could help in triage, initial treatment, and further decision-making for outcome measures in trauma patients. Clinical and paraclinical variables after resuscitation could predict short-term outcomes much better than variables on arrival. With artificial intelligence modeling system, diastolic blood pressure after resuscitation has a greater association with predicting early mortality rather than systolic blood pressure after resuscitation. Artificial intelligence monitoring may have a role in trauma care and should be further investigated.

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.

Electrocardiographic findings of methanol toxicity: a cross-sectional study of 356 cases in Iran.

BACKGROUND: Methanol is widely used in industry; however, methanol poisoning is not common. In this regard, a number of outbreaks have been recently reported due to inappropriate processing of alcoholic beverages. Shiraz, a city located in the southern part of Iran, faced one of such outbreaks in 2020 during COVID-19 pandemic. There is no sufficient literature on the electrocardiographic findings in methanol toxicity. This study aimed to address this gap in the literature. METHOD: A total of 356 cases with methanol toxicity referred to Shiraz University of Medical Science Tertiary Hospitals (Faghihi and Namazi) in March and April, 2020. The clinical findings of blindness and impaired level of consciousness, lab data such as arterial blood gas, electrolytes, and creatinine, and the most common findings from ECGs were collected. RESULTS: The most common ECG findings were J point elevation (68.8%), presence of U wave (59.2%), QTc prolongation (53.2% in males and 28.6% in females), and fragmented QRS (33.7%). An outstanding finding in this study was the presence of myocardial infarction in 5.3% of the cases. This finding, to the best of our knowledge, has only been reported in a few case reports. Brugada pattern (8.1%) and Osborn wave (3.7%) were the other interesting findings. In multivariate analysis, when confounding factors were adjusted, myocardial infarction, atrioventricular conduction disturbances, sinus tachycardia, and the prolonged QTC > 500 msecond were four independent factors correlated with methanol toxicity severity measured with arterial blood PH on arterial blood gas measurements, with odds ratios of 12.82, 4.46, 2.32 and 3.15 (P < 0.05 for all), respectively. CONCLUSION: Electrocardiographic variations during methanol intoxication are remarkable and well-correlated with poisoning severity. Myocardial infarction was an egregious and yet a common concerning finding in this sample, which need to be ruled out in methanol toxicity.

Socioeconomic-related inequalities in oral hygiene behaviors: a cross-sectional analysis of the PERSIAN cohort study.

BACKGROUND: Socioeconomic-related inequality in oral hygiene behaviors in Iran is poorly understood. This study aims to measure and decompose socioeconomic-related inequalities in oral hygiene behaviors among middle-aged and elderly adults in Iran. METHODS: A cross-sectional analysis was performed using data from the Prospective Epidemiological Research Studies in IrAN (PERSIAN), a large national cohort study. A total of 130,016 individuals aged 35 years and above from 17 cohort centers in Iran were included in the study. The normalized concentration index (Cn) was used to measure the magnitude of inequality in oral hygiene behaviors, i.e. brushing at least twice and flossing once daily, among middle-aged and elderly Iranian adults included in the cohort centers. Decomposition analysis was performed to quantify the contribution of each determinant to the observed inequality in oral hygiene behaviors. RESULTS: Totally, 65.5% of middle-aged and elderly adults brushed their teeth twice a day or more, 7.6% flossed at least once a day and 3.48% had both habits. The estimated Cn of the two habits combined, i.e. tooth brushing and dental flossing, for all provinces taken part in the PERSIAN cohort study was 0.399 (95% confidence interval [CI]: 0.383 to 0.417), indicating that the prevalence of the two habits combined is more concentrated among individuals with higher socioeconomic status. Inequality in oral hygiene behaviors was pro-rich in all cohort centers. The decomposition results suggested socioeconomic status as the main factor contributing to the overall inequality, followed by the level of education, and the province of residence. CONCLUSION: A low prevalence of oral hygiene behaviors among middle-aged and elderly Iranian adults was observed. There was also a pro-rich inequality in oral hygiene behaviors among middle-aged and elderly adults in all cohort centers. These results suggest an urgent need for targeted policy interventions to increase the prevalence of preventive oral hygiene behaviors among the poor and less-educated middle-aged and elderly adults in Iran.

Adherence to the algorithmic approach for diagnosis of pulmonary embolism: A teaching hospital experience, Shiraz, Iran.

BACKGROUND: We evaluated to see if the algorithmic approach of pulmonary embolism (PE) [Wells' score, followed by D-dimer test and computed tomography pulmonary angiography (CTPA)] is appropriately followed in teaching hospitals of Shiraz, Iran. METHODS: From October 2012 to October 2013, we prospectively calculated Wells' score for all patients who underwent CTPA with clinical suspicion to PE; patients with low probability who had not checked the D-dimer or had low level of D-dimer were considered as non-adherent to the guideline and those with high level of D-dimer or high probability of Wells' score were labeled as adherent to the PE guideline. CTPA scans were independently reported by two radiologists. RESULTS: During study period, 364 patients underwent CTPA to rule out PE, of which 125 (34.3%) had Wells' score > 4 (high probable risk) and 239 had Wells' score ≤ 4. Amongst low probable risk patients (Wells' score ≤ 4), only 32 patients had undergone the D-dimer test (23 patients had high level of D-dimer). Based on the algorithmic approach, patients with suspected PE, patients with high probability (125 patients), and patients with low probability with elevated D-dimer level (23 patients) were considered as adherent to the PE guideline; consequently, the total adherence to PE guideline was 148 out of 364 (40.6%). CONCLUSION: We followed the algorithmic approach guideline in about 40.0% of cases; however, we should pay more attention to the algorithmic approach in patients with suspected PE.

Combination of different clinical reasoning tests in a national exam.

INTRODUCTION: Clinical reasoning as a critical and high level of clinical competency should be acquired during medical education, and medical educators should attempt to assess this ability in medical students. Nowadays, there are several ways to evaluate medical students' clinical reasoning ability in different countries worldwide. There are some well-known clinical reasoning tests such as Key Feature (KF), Clinical Reasoning Problem (CRP), Script Concordance Test (SCT), and Comprehensive Integrative Puzzle (CIP). Each of these tests has its advantages and disadvantages. In this study, we evaluated the reliability of combination of clinical reasoning tests SCT, KF, CIP, and CRP in one national exam and the correlation between the subtest scores of these tests together with the total score of the exam. METHODS: In this cross sectional study, a total number of 339 high ranked medical students from 60 medical schools in Iran participated in a national exam named "Medical Olympiad". The ninth Medical Olympiad was held in Shahid Beheshti University of Medical Sciences, Tehran, Iran, under the direct supervision of the Ministry of Health and Medical Education in summer 2017. The expert group designed a combination of four types of clinical reasoning tests to assess both analytical and non-analytical clinical reasoning. Mean scores of SCT, CRP, KF, and CIP were measured using descriptive statistics. Reliability was calculated for each test and the combination of tests using Cronbach's alpha. Spearman's correlation coefficient was used to evaluate the correlation between the score of each subtest and the total score. SPSS version 21 was used for data analysis and the level of significance was considered <0.05. RESULTS: The reliability of the combination of tests was 0.815. The reliability of KF was 0.81 and 0.76, 0.80, and 0.92 for SCT, CRP, and CIP, respectively. The mean total score was 169.921±41.54 from 240. All correlations between each clinical reasoning test and total score were significant (P<0.001). The highest correlation (0.887) was seen between CIP score and total score. CONCLUSION: The study showed that combining different clinical reasoning tests can be a reliable way of measuring this ability.

Treatment options for nonalcoholic fatty liver disease: a double-blinded randomized placebo-controlled trial.

INTRODUCTION: Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and is becoming the most frequent indication of liver transplantation. Cardiovascular disease is the main cause of death in these patients. There is no Food and Drug Association-approved medication for NAFLD patients. We aimed to provide more robust evidence on the use of medications that are inexpensive and available, namely, metformin, silymarin, pioglitazone, and vitamin E, for treating NAFLD. MATERIALS AND METHODS: We conducted a randomized double-blinded, placebo-controlled trial on 150 consecutive patients with NAFLD who were assigned to five groups: lifestyle plus placebo, metformin 500 mg/day, silymarin 140 mg/day, pioglithasone 15 mg/day, and vitamin E 400 IU/day, all for 3 months. Anthropometric and biochemical variables were measured at baseline and 3 months later. RESULTS: The mean age of the patients was 47.0±9.1 (range: 18-65) years and the sex distribution was 73 (48.7%) women and 77 (51.3%) men. Patients in all groups showed a significant improvement in anthropometric parameters such as waist circumference and BMI. There was no statistically significant difference in alanine transaminase and aspartate transaminase in the control group after treatment (P=0.51, 0.18, respectively); however, both liver enzymes decreased significantly in the other groups. DISCUSSION AND CONCLUSION: This randomized double-blinded placebo-controlled clinical trial suggested a significant benefit of silymarin, pioglitazone, and vitamin E in improving liver aminotransferases in patients with NAFLD after only 3 months, without exerting any specific side effects.