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 (370%) 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) ofthe 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. © 2016, Academy of Medical Sciences of I.R. Iran. All rights reserved

Polycyclic aromatic hydrocarbons and esophageal squamous cell carcinoma

Esophageal cancer (EC) is the 8th most common cancer and the 6th most frequent cause of cancer mortality worldwide. Esophageal squamous cell carcinoma (ESCC) is the most common type of EC. Exposure to polycyclic aromatic hydrocarbons (PAHs) has been suggested as a risk factor for developing ESCC. In this paper we will review different aspects of the relationship between PAH exposure and ESCC. PAHs are a group of compounds that are formed by incomplete combustion of organic matter. Studies in humans have shown an association between PAH exposure and development of ESCC in many populations. The results of a recent case-control study in a high risk population in northeastern Iran showed a dramatic dose-response relationship between PAH content in non-tumor esophageal tissue (the target tissue for esophageal carcinogenesis) and ESCC case status, consistent with a causal role for PAH exposure in the pathogenesis of ESCC. Identifying the main sources of exposure to PAHs may be the first and most important step in designing appropriate PAH-reduction interventions for controlling ESCC, especially in high risk areas. Coal smoke and drinking mate have been suggested as important modifiable sources of PAH exposure in China and Brazil, respectively. But the primary source of exposure to PAHs in other high risk areas for ESCC, such as northeastern Iran, has not yet been identified. Thus, environmental studies to determining important sources of PAH exposure should be considered as a high priority in future research projects in these areas

Central obesity and advanced liver stiffness in Hepatitis B: Result from golestan hepatitis B cohort study

Background: Chronic infection with the hepatitis B virus and obesity may both contribute synergistically to liver disease, although relatively few studies have investigated this hypothesis. Therefore, in this study, we evaluated the relationship between central obesity and the liver stiffness in the Golestan Hepatitis B cohort study (GHBCS). Methods: Our study included 304 chronic hepatitis B (CHB) patients enrolled from GHBCS. Liver stiffness measurement (LSM) and laboratory tests were performed after a follow-up of 4 years (2012). The hepatitis B viral load was measured at the baseline and follow-up using the real-time PCR method. Waist circumference ≥102 cm in men and ≥ 89 cm in women (central obesity) was considered to be abnormal. Advanced liver stiffness (ALS) was defined as LSM≥8 KPa. Statistical analysis was performed using SPSS-V17. Logistic regression was used to test predictors of advanced liver stiffness (LSM ≥ 8 KPa). Linear regression was used to test the predictive value of variables in ALT (as a continuous variable). P-value of less than 0.05 was considered statistically significant. Results: Among these CHB patients, 19 (7.4%) cases with a mean (±SD) age of 49.5 (±6.3) developed ALS after 4 years of follow-up. Multivariate analysis showed a significant predictive role of central obesity and viral load in ALS. Conclusions: Central obesity is related to the liver stiffness in chronic hepatitis B patients. © 2015, Academy of Medical Sciences of I.R. Iran. All rights reserved

The upper normal limit of serum alanine aminotransferase in Golestan Province, Northeast Iran

Background: The objective of this study was to determine the upper normal limit of serum alanine aminotransferase level in a population-based study in Golestan Province, northeast Iran. Methods: From the randomly invited individuals (2,292), 698 out of the 916 males and 1,351 out of the 1,376 females participated in the study (participation rate: 76.2 and 98.1, respectively). One hundred and twenty-one participants were excluded due to positive hepatitis B surface antigen or hepatitis C virus antibody and/or drinking more than 20 grams of alcohol per day. A total of 1,928 participants (1300 females) were included. The upper normal limit of serum alanine aminotransferase level was defined as the 95th percentile. Results: The upper normal limit of serum alanine aminotransferase level in normal weight and nondiabetics was significantly lower than the total study group (36 versus 45 U/L). Serum alanine aminotransferase level was independently associated with male gender, body mass index, and diabetes mellitus (OR=2.05; 95Cl: 1.44 - 2.94, OR=2.76; 95Cl: 1.84 - 4.13, and OR=2.96; 95Cl: 1.56-5.61, respectively). Conclusion: Considering the lower calculated upper normal limit in normal weight nondiabetic participants in this study, we recommend setting new upper normal limit for serum alanine aminotransferase level, It seems reasonable to set upper normal limit for serum alanine aminotransferase level in males and females separately

The upper normal limit of serum alanine aminotransferase in Golestan Province, Northeast Iran

Background: The objective of this study was to determine the upper normal limit of serum alanine aminotransferase level in a population-based study in Golestan Province, northeast Iran. Methods: From the randomly invited individuals (2,292), 698 out of the 916 males and 1,351 out of the 1,376 females participated in the study (participation rate: 76.2 and 98.1, respectively). One hundred and twenty-one participants were excluded due to positive hepatitis B surface antigen or hepatitis C virus antibody and/or drinking more than 20 grams of alcohol per day. A total of 1,928 participants (1300 females) were included. The upper normal limit of serum alanine aminotransferase level was defined as the 95th percentile. Results: The upper normal limit of serum alanine aminotransferase level in normal weight and nondiabetics was significantly lower than the total study group (36 versus 45 U/L). Serum alanine aminotransferase level was independently associated with male gender, body mass index, and diabetes mellitus (OR=2.05; 95Cl: 1.44 - 2.94, OR=2.76; 95Cl: 1.84 - 4.13, and OR=2.96; 95Cl: 1.56-5.61, respectively). Conclusion: Considering the lower calculated upper normal limit in normal weight nondiabetic participants in this study, we recommend setting new upper normal limit for serum alanine aminotransferase level, It seems reasonable to set upper normal limit for serum alanine aminotransferase level in males and females separately

The impact of illicit drug use on Spontaneous Hepatitis C Clearance: Experience from a large cohort population study

Background and Aims: Acute hepatitis C infection usually ends in chronic infection, while in a minority of patients it is spontaneously cleared. The current population-based study is performed on a large cohort in Golestan province of Iran to examine the demographic correlates of Spontaneous Hepatitis C Clearance. Methods: Serum samples used in this study had been stored in biorepository of Golestan Cohort Study. These samples were evaluated for anti hepatitis C Virus by third generation Enzyme-linked immunosorbent assay (ELISA). Subjects who tested positive were then invited and tested by Recombinant Immunoblot Assay (RIBA) and Ribonucleic Acid Polymerase Chain Reaction test (PCR). If tested positive for RIBA, subjects were recalled and the two tests were re-done after 6 months. Those subjects who again tested positive for RIBA but negative for PCR were marked as cases of spontaneous clearance. Results: 49,338 serum samples were evaluated. The prevalence of Chronic Hepatitis C Virus (CHCV) infection based on PCR results was 0.31. Among those who had acquired hepatitis C, the rate of SC was 38. In multivariate analysis, illicit drug use both Injecting Use (OR = 3.271, 95 CI: 1.784-6.000, p-value<0.001) and Non-Injecting Use (OR = 1.901, 95 CI: 1.068-3.386, p-value = 0.029) were significant correlates of CHCV infection versus SC. Conclusions: Illicit drug use whether intravenous or non-intravenous is the only significant correlate of CHCV, for which several underlying mechanisms can be postulated including repeated contacts with hepatitis C antigen. © 2011 Poustchi et al

Prevalence of chronic kidney disease and its associated risk factors: The first report from Iran using both microalbuminuria and urine sediment

Background: The incidence of major risk factors of chronic kidney disease (CKD) in the world is on the rise, and it is expected that this incidence and prevalence, particularly in developing countries, will continue to increase. Using data on urinary sediment and microalbuminuria, we aimed to estimate the prevalence of CKD in northeast Iran. Methods: In a cross-sectional study, the prevalence of CKD in a sample of 1557 regionally representative people, aged � 18 years, was analyzed. CKD was determined based on glomerular filtration rate (GFR) and microalbuminuria. Life style data, urine and blood samples were collected. Urine samples without any proteinuria in the initial dipstick test were checked for qualitative microalbuminuria. If the latter was positive, quantitative microalbuminuria was evaluated. Results: 1557 subjects with a mean age of 56.76 ± 12.04 years were enrolled in this study. Based on the modifcation of diet in renal disease (MDRD) equation, 137 subjects (8.89%) were categorized as CKD stages III-V. Based on urine abnormalities, the prevalence of combined CKD stages I and II was 10.63%, and based on macro- and microalbuminuria it was 14.53%. The prevalence of CKD was significantly associated with sex, age, marital status, education, diabetes mellitus (DM), hypertension (HTN), ischemic heart disease (IHD), waist to hip ratio, myocardial infarction (MI), and cerebrovascular accident (CVA). Conclusion: CKD and its main risk factors are common and represent a definite health threat in this region of Iran. Using and standardizing less expensive screening tests in low resource countries could be a good alternative that may improve the outcome through early detection of CKD

Marked increase in the incidence rate of esophageal adenocarcinoma in a high-risk area for esophageal cancer

BACKGROUND: Esophageal cancer (EC) is the eighth common cancer worldwide. Esophageal squamous cell carcinoma (ESCC) and adenocarcinoma (EAD) are the most common histologic types of EC. Many recent reports showed an increasing trend in EAD and a decreasing trend in ESCC in many Western countries. Golestan Province in northeastern Iran has been known as a high-risk area for EC. The aim of this study was to describe the time trend of EAD in this area between 2000-2009. METHODS: Data on cancer cases were obtained from Golestan Population-based Cancer Registry. Analysis was done using Joinpoint software. To examine the incidence trends, the annual percent change was calculated. The possibilities of anatomic and histologic misclassification were considered by assessing the trend of ESCC and gastric adenocarcinoma. RESULTS: A total number of 1186 histologically-confirmed EC cases were recruited. The incidence rate of EAD showed a significant increasing trend. There was no significant trend in the incidence of ESCC during the study period. A significant increase in the incidence rate of gastric adenocarcinoma was observed during the period of 2000-2005, followed by a plateau during the period of 2005-2009. CONCLUSIONS: We found a significant increasing trend in the incidence rate of EAD. We find no evidence to support an alternative explanation including anatomic and histologic misclassification. So, the observed rise in the incidence of EAD seems to be real. Therefore, designing and implementation of control programs, including control of preventable risk factors of EAD, should be considered in this high- risk area

Association of mutations in the basal core promoter and pre-core regions of the hepatitis B viral genome and longitudinal changes in HBV level in HBEAG negative individuals: Results from a cohort study in northern Iran

Background: Although certain HBV mutations are known to affect the expression of Hepatitis e antigen, their association with HBV viral level or clinical outcomes is less clear. Objectives: We evaluated associations between different mutations in the Basal Core promoter (BCP) and Pre-core (PC) regions of HBV genome and subsequent changes in HBV viral DNA level over seven years in a population of untreated HBeAg negative chronic hepatitis B (CHB) participants in Northeast of Iran. Materials and Methods: Participants in the current study were drawn from the Golestan Hepatitis B Cohort Study (GHBCS), a cohort of approximately 2590 HBsAg positive subjects (living in Gonbad city) embedded in the Golestan Cohort Study (GCS). At baseline, HBsAg was measured in all participants and revealed 2590 HBsAg positive cases. We randomly selected 304 participants who their blood sample were taken at both baseline and seven years later in follow-up and had not been treated for HBV during this time. HBV viral load were assessed at baseline and at year 7. The BCP and PC regions of the HBV DNA, at baseline, were amplified via hemi-nested PCR and sequenced by cycle sequencing. At year 7, liver stiffness was assessed by fibroscan; also, other parameters of liver disease were assessed following standard clinical protocols. Associations were assessed via tabulation, chi-square, t-tests and logistic regression. P values < 0.05 were considered statistically significant and all tests were two-sided. Results: Among 304 HBsAg positive participants, 99 had detectable HBV DNA at study baseline. Of these, 61.6% had PC mutations (48.5% A1896 and 25.2% G1899). In contrast to other mutations, A1896 was associated with a higher proportion of detectable HBV DNA at year 7 (39.6%) compared to patients with the wild type (13.7%) (OR: 4.36, CI95% = 1.63-11.70; P Value = 0.002). Although participants with the A1896 mutation had higher year-7 HBV viral load than participants with G1896 (2.30 ± 1.66 IU/mL vs. 1.76 ± 1 IU/mL among patients with detectable HBV; P value = 0.052), no association was observed with either serum level ALT or liver stiffness. Interestingly, mutations in the basal core promoter (BCP) region had no significant effect on virus DNA detection. Conclusions: In this population with chronic HBeAg negative hepatitis B, an association was observed between the G1896A mutation in the Pre-core region of HBV and subsequent level of HBV DNA seven years later, which indicated that mutations in this region of HBV genome may contribute to disease progression in these patients and play an important role in HBV natural course of disease. © 2015, Kowsar Corp

Cancer incidence in Golestan province: Report of an ongoing population-based cancer registry in Iran between 2004 and 2008

Background: Golestan Province, at the western end of the Asian esophageal cancer (EC) belt in northeastern Iran, was reported to have one of the highest worldwide rates of EC in the 1970s. We have previously shown a declining incidence of EC in Golestan during the last decades. This study reports additional new results from the Golestan Population-based Cancer Registry (GPCR). Methods: The GPCR collected data from newly diagnosed (incident) cancer cases from all 68 public and private diagnostic and therapeutic centers in Golestan Province. CanReg-4 software was used for data entry and analysis based on the guidelines of the International Agency for Research on Cancer (IARC). Age-standardized incidence rates (ASR) of cancers were calculated using the 2000 world standard population. Results: From 2004 through 2008, 9007 new cancer cases were reported to the GPCR. The mean (SD) age was 55.5 (18.6) years, and 54 were diagnosed in men. The ASRs of all cancers were 175.3 and 141.1 per 100,000 person-years for males and females, respectively. Cancers of the stomach (ASR:30.7), esophagus (24.3), and lung (15.4) were the most common cancers in males. In females, breast cancer (ASR:26.9) was followed by malignancies of the esophagus (19.1) and stomach (12.4). The diagnosis of cancer was based on histopatho- logical reports in 71 and on death certificate only in 9 ofcases. Conclusions: The EC incidence rate continues to decline in Golestan, while the incidence rates of stomach, colorectal, and breast cancers continue to increase