Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies : A systematic review

This study was funded by Iran University of Medical Sciences (grant number 97-01-27-33259).Peer reviewedPublisher PD

Association between individual, household, and area-level socioeconomic status indicators and sensorineural hearing loss in adults in southwest Iran: a population-based study

IntroductionHearing loss is the fourth most common chronic disease, but studies on the relationship between hearing loss and socioeconomic factors are limited. We aimed to examine the association between hearing loss and socioeconomic factors among 35–70 year adults in southwest Iran.Materials and methodsThis population-based cross-sectional study was conducted in the baseline of Hoveyzeh cohort study in adults aged 35–70 in southwest Iran between 2017 and 2021. Information on socioeconomic factors, demographic characteristics, comorbidities, family history of hearing loss, and noise exposure was collected. We assessed the relationship between three levels of socioeconomic factors (individual, household, and area level) with sensorineural hearing loss (SNHL). Multiple logistic regression was used to adjust the potential confounders.ResultsAmong a total of 1,365 assessed participants, 485 patients were diagnosed as having hearing loss, and the other 880 individuals were diagnosed without hearing loss, which is considered the case and the control group, respectively. At the individual level of socioeconomic, the odds of having hearing loss in the participants with high school education and diploma, [OR = 0.51 (95%CI:0.28–0.92)], and the individuals with university education [OR = 0.44 (95%CI:0.22–0.87)] were significantly lower than the illiterate participants. At the household socioeconomic level, the odds of having hearing loss were lower for those with poor [OR = 0.63 (95%CI:0.41–0.97)] and moderate [OR = 0.62 (95%CI:0.41–0.94)] wealth status vs. those with the poorest wealth status. In the area level socioeconomic, although the odds of hearing loss in the residents of affluent areas were slightly lower than the residents of deprived areas, there was no significant difference among the groups.ConclusionThe individuals with hearing loss may have insufficient education and income

Province-level Prevalence of Psychiatric Disorders: Application of Small-Area Methodology to the Iranian Mental Health Survey (IranMHS)

Objective: National surveys revealed a high prevalence of psychiatric disorders in Iran. Province-level estimates are needed to manage the resources and focus on preventive efforts more efficiently. The objective of this study was to provide province-level estimates of psychiatric disorders. Method: In this study, Iranian Mental Health Survey (IranMHS) data (n = 7886) was used to produce province-level prevalence estimates of any psychiatric disorders among 15-64 year old males and females. Psychiatric disorders were diagnosed based on structured diagnostic interview of the Persian version of Composite International Diagnostic Interview (CIDI, version, 2.1). The Hierarchical Bayesian (HB) random effect model was used to calculate the estimates. The mental health status of half of the participants was also measured using a 28-item general health questionnaire (GHQ). Results: A wide variation in the prevalence of psychiatric disorders was found among 31 provinces of Iran. The direct estimates ranged from 3.6% to 62.6%, while the HB estimates ranged from 12.6% to 36.5%. The provincial prevalence among men ranged from 11.9% to 34.5%, while it ranged from 18.4% to 38.8% among women. The Pearson correlation coefficient between HB estimates and GHQ scores was 0.73. Conclusion: The Bayesian small area estimation provides estimation with improved precision at local levels. Detecting high-priority communities with small-area approach could lead to a better distribution of limited facilities and more effective mental health interventions

Type 2 diabetes remission after Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and one anastomosis gastric bypass (OAGB) : results of the longitudinal assessment of bariatric surgery study

Acknowledgements The authors would like to thank the staff at the Minimally Invasive Surgery Research Center (MISRC) in Rasoul-e-Akram Hospital. Funding Information: This study was supported by the Deputy of Research of Iran University of Medical Sciences, Tehran, Iran.Peer reviewedPublisher PD

Does fasting plasma glucose values 5.1-5.6 mmol/l in the first trimester of gestation a matter?

ObjectivesThe aim of the study was to investigate the effect of treatment on pregnancy outcomes among women who had fasting plasma glucose (FPG) 5.1-5.6 mmol/l in the first trimester of pregnancy.MethodsWe performed a secondary-analysis of a randomized community non-inferiority trial of gestational diabetes mellitus (GDM) screening. All pregnant women with FPG values range 5.1-5.6 mmol/l in the first trimester of gestation were included in the present study (n=3297) and classified to either the (i) intervention group who received treatment for GDM along with usual prenatal care (n=1,198), (ii) control group who received usual-prenatal-care (n=2,099). Macrosomia/large for gestational age (LGA) and primary cesarean-section (C-S) were considered as primary-outcomes. A modified-Poisson-regression for binary outcome data with a log link function and robust error variance was used to RR (95%CI) for the associations between GDM status and incidence of pregnancy outcomes.ResultsThe mean maternal age and BMI of pregnant women in both study groups were similar. There were no statistically significant differences in the adjusted risks of adverse pregnancy outcomes, including macrosomia, primary C-S, preterm birth, hyperbilirubinemia, preeclampsia, NICU-admission, birth trauma, and LBW both groups.ConclusionsIt is found that treating women with first-trimester FPG values of 5.1-5.6 mmol/l could not improve adverse pregnancy outcomes including macrosomia, Primary C-S, Preterm birth, hypoglycemia, hypocalcemia, preeclampsia, NICU admission, Birth trauma and LBW. Therefore, extrapolating the FPG cut-off point of the second trimester to the first –which has been proposed by the IADPSG, might therefore not be appropriate.Clinical Trial Registrationhttps://www.irct.ir/trial/518, identifier IRCT138707081281N1

Epidemiology of oesophageal adenocarcinoma

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Data management system for diabetes clinical trials: a pre-post evaluation study

Abstract Background Data management system for diabetes clinical trials is used to support clinical data management processes. The purpose of this study was to evaluate the quality and usability of this system from the users’ perspectives. Methods This study was conducted in 2020, and the pre-post evaluation method was used to examine the quality and usability of the designed system. Initially, a questionnaire was designed and distributed among the researchers who were involved in the diabetes clinical trials (n = 30) to investigate their expectations. Then, the researchers were asked to use the system and explain their perspectives about it by completing two questionnaires. Results There was no statistically significant differences between the users’ perspectives about the information quality, service quality, achievements, and communication before and after using the system. However, in terms of the system quality (P = 0.042) and users’ autonomy (P = 0.026), the users’ expectations were greater than the system performance. The system usability was at a good level based on the users’ opinions. Conclusion It seems that the designed system largely met the users’ expectations in most areas. However, the system quality and users’ autonomy need further attentions. In addition, the system should be used in multicenter trials and re-evaluated by a larger group of users

Fracture Risk in People With Primary Biliary Cirrhosis: A Population-Based Cohort Study

Background & Aims: Controversy exists as to whether people with primary biliary cirrhosis (PBC) have an increased risk of developing osteoporosis and the extent to which this may translate into an increased risk of fracture. We have performed a cohort study using the General Practice Research Database to quantify the excess fracture risk in people with PBC. Methods: We identified 930 people with PBC and 9202 age- and sex-matched control subjects. We used Cox regression to estimate the hazard ratios for any fracture, hip fracture, and ulna/radius fracture in the PBC cohort compared with the general population. Results: There were approximately 2-fold relative increases in the risk of any fracture, hip fracture, and ulna/radius fracture for the PBC cohort compared with the general population (hazard ratio [HR], 2.03; 95% confidence interval [CI]: 1.70–2.44; HR 2.14 (95% CI: 1.40–3.28), and HR, 1.96; 95% CI: 1.42–2.71, respectively). The absolute excess in fracture rates were for any fracture, 12.5 per 1000 person-years (95% CI: 8.1–16.9); for hip fracture, 1.9 per 1000 person-years (95% CI: 0.3–3.5); and for ulna/radius fracture, 3.4 per 1000 person-years (95% CI: 1.2–5.7). In those people with more severe disease, the relative risks of fracture were similar (any fracture HR, 2.24; hip fracture HR, 1.25; ulna/radius fracture HR, 1.28). Conclusions: There are modest increases in both the absolute and relative fracture risks in people with PBC compared with the general population, with the excess risks similar in those with more severe disease

Serum variations of anti-mullerian hormone and total testosterone with aging in healthy adult Iranian men: A population-based study.

Literature proves anti-mullerian hormone (AMH) and total testosterone (TT) as two important reproductive hormones in male development, however evidence regarding age variations of these hormones is lacking.To estimate the normal serum AMH values and to assess the age-specific TT levels in men aged 30-70, we conducted the present population-based study.A total of 831 healthy eligible men, aged 30-70 years, were recruited from Tehran Lipid and Glucose study cohort. Centiles for AMH were estimated according to the exponential normal 3-parameter model. The parametric method of Royston available in general software was applied for the first time to estimate the age-specific AMH and TT percentiles of 5th, 10th, 25th, 50th, 75th, 90th and 95th.Mean AMH level was 6.93, ranging from 0.1 to 40.1 ng/ml. Serum AMH concentrations followed a steady reduction with increasing age. Mean TT level was 4.8, ranging from 0.44 to 11.4 ng/ml.A measurable serum concentrations of AMH in healthy males throughout lifespan with variations, based on age, confirming a slight age-related AMH decline. Fractional polynomial (FP) regression models revealed that the mean and standard deviation (SD) of the TT were not associated with age, so the percentiles estimated were not age-specific.We presented a nomogram of age-specific AMH values in a healthy cohort of Iranian men. This finding might have clinical importance in dealing hormonal disorders in men