Risks of congenital malformations and neonatal intensive care unit admissions with gabapentin use in pregnancy: A cohort study and scoping review with meta-analysis.

BACKGROUND: The increasing and prevalent use of gabapentin among pregnant people highlights the necessity to assess its neonatal safety. OBJECTIVES: This study aimed to investigate the foetal safety of gabapentin during pregnancy using a cohort study and scoping review with a meta-analysis of published evidence. METHODS: We conducted a population-based cohort study using the Manitoba health databases between 1995 and 2019. We examined the association between gabapentin use during pregnancy and the prevalence of major congenital malformations, cardiac and orofacial malformations, and neonatal intensive care unit (NICU) admissions using multivariate regression models. We searched the literature in MEDLINE and EMBASE databases from inception to October 2022 to identify relevant observational studies and conducted a meta-analysis using random-effects models, including our cohort study results. RESULTS: Of the 289,227 included pregnancies, 870 pregnant people were exposed to gabapentin. Gabapentin exposure during the First trimester was not associated with an increased risk of any malformations (adjusted relative risk [aRR]) 1.16 (95% confidence interval [CI] 0.92, 1.46), cardiac malformations (aRR 1.29, 95% CI 0.72, 2.29), orofacial malformations (aRR 1.37, 95% CI 0.50, 3.75), and major congenital malformations (aRR 1.00, 95% CI 0.73, 1.36). whereas exposure during any trimester was associated with an increased NICU admission risk (aRR, 1.99 [95% CI 1.70, 2.32]). The meta-analysis of unadjusted results revealed an increased risk of major congenital malformations (RR 1.44, 95% CI 1.28, 1.61, I2 = 0%), cardiac malformations (RR 1.66, 95% CI 1.11, 2.47, I2 = 68%), and NICU admissions (RR 3.15, 95% CI 2.90, 3.41, I2 = 10%), and increased trend of orofacial malformations (RR 1.98, 95% CI 0.79, 5.00, I2 = 0%). CONCLUSIONS: Gabapentin use was associated with an increased risk of NICU admissions in the cohort study and pooled meta-analysis. Clinicians should prescribe gabapentin with caution during pregnancy and further studies are warranted.

Antiseizure medication use during pregnancy and neonatal growth outcomes: A systematic review and meta-analysis.

AIMS: We aimed to systematically synthesize the current published literature on neonatal growth outcomes associated with antiseizure medication (ASM) use during pregnancy. METHODS: We searched seven databases, from inception to 23 March 2022. We investigated small for gestational age (SGA) and low birth weight (LBW) as primary outcomes and birth weight, birth height, cephalization index and head circumference as secondary outcomes. The primary analysis included pregnant people exposed to any ASM compared with unexposed pregnant people. Subgroup analysis included ASM class analysis, within epilepsy group analysis and polytherapy compared to monotherapy. RESULTS: We screened 15 720 citations and included 65 studies in the review. Exposed pregnant people had a significantly increased risk of SGA relative risk (RR) 1.33 (95% CI 1.18 to 1.50, I2 74%), LBW RR 1.54 (95% CI 1.33 to 1.77, I2 67%), and decreased birth weight with a mean difference (MD) of -118.87 (95% CI -161.03 to -76.71, I2 42%) g. A non-significant risk change in birth height and head circumference was observed. In subgroup analysis, ASM polytherapy, within epilepsy and ASM class analysis were also associated with an increased risk of SGA and LBW. CONCLUSIONS: This meta-analysis demonstrates that pregnant people exposed to ASMs have a significantly increased risk of adverse fetal growth outcomes including SGA and LBW and decreased birth weight compared to unexposed pregnant people. Polytherapy was associated with higher risks compared to monotherapy. Additional studies are warranted on specific ASM risks.

Evaluation of factors that influenced the length of hospital stay using data mining techniques.

BACKGROUND: length of stay (LOS) is the time between hospital admission and discharge. LOS has an impact on hospital management and hospital care functions. METHODS: A descriptive, retrospective study was designed on about 27,500 inpatients between March 2019 and 2020. Required data were collected from six wards (CCU, ICU, NICU, General, Maternity, and Women) in a teaching hospital. Clinical data such as demographic characteristics (age, sex), type of ward, and duration of hospital stay were analyzed by the R-studio program. Violin plots, bar charts, mosaic plots, and tree-based models were used to demonstrate the results. RESULTS: The mean age of the population was 40.8 ± 19.2 years. The LOS of the study population was 2.43 ± 4.13 days. About 60% of patients were discharged after staying one day in the hospital. After staying one day in the hospital, 67% of women were discharged. However, 23% of men were discharged within this time frame. The majority of LOS in the CCU, ICU, and NICU ranged from 5 to 9 days.; In contrast, LOS was one day in General, Maternity, and Woman wards. Due to the tree plot, there was a different LOS pattern between Maternity-Women and the CCU-General-ICU-NICU wards group. CONCLUSION: We observed that patients with more severe diseases hospitalized in critical care wards had a longer LOS than those not admitted to critical care wards. The older patient had longer hospital LOS than the younger. By excluding Maternity and Woman wards, LOS in the hospital was comparable between males and females and demonstrated a similar pattern.

The effects of statin use on inflammatory markers among patients with metabolic syndrome and related disorders: A systematic review and meta-analysis of randomized controlled trials.

Current evidence suggests that statin use decreases the incidence of cardiovascular diseases (CVD) through reducing LDL cholesterol and decreasing inflammation. Metabolic syndrome (MetS) is usually associated with increased inflammatory markers and increased risk of CVD. We conducted a systematic review and meta-analysis to determine the effect of statin use on inflammatory markers including C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and interleukin-1 (IL-1) among patients with MetS and related disorders. PubMed, EMBASE, Web of Science databases, and Cochrane Library were searched for randomized controlled trials (RCTs) through April 2018. Three independent investigators evaluated study eligibilities, extracted data, and assessed study quality using the Cochrane Collaboration risk of bias tool and Jadad's quality scales. Heterogeneity was determined using Cochran's Q statistic and I-square (I2) test. Based on the heterogeneity results, we pooled data using random-effect or fixed effect models presented as standardized mean differences (SMD) and corresponding 95% confidence intervals (CI). One hundred thirteen RCTs (19,644 patients) were included in our meta-analysis. The pooled results using random effects model showed that statin use statistically significantly decreased CRP level (SMD= -0.97; 95% CI, -1.10, -0.85; P < 0.001; I2: 95.1%), TNF-α (SMD= -1.88; 95% CI, -2.40, -1.38; P < 0.001; I2: 97.2%), IL-6 (SMD= -1.67; 95% CI, -1.98, -1.34; P < 0.001; I2: 96.5%), and IL-1 concentrations (SMD= -8.35; 95% CI, -10.49, -6.22; P < 0.001; I2: 98.4%) among patients with MetS and related disorders. Our meta-analysis showed beneficial effects of statin use on reducing inflammatory markers in patients with MetS and related disorders.

The effects of inositol supplementation on lipid profiles among patients with metabolic diseases: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Several studies have evaluated the effect of inositol supplementation on lipid profiles among population with metabolic diseases; however, the findings are controversial. This review of randomized controlled trials (RCTs) was performed to summarize the evidence of the effects of inositol supplementation on lipid profiles among population with metabolic diseases. METHODS: Relevant RCTs studies were searched in Cochrane Library, EMBASE, MEDLINE, and Web of Science until October 2017. Two researchers assessed study eligibility, extracted data, and evaluated risk of bias of included primary studies, independently. To check for the heterogeneity among included studies Q-test and I2 statistics were used. Data were pooled by using the random-effect model and standardized mean difference (SMD) was considered as summary of the effect size. RESULTS: Overall, 14 RCTs were included into meta-analysis. Pooled results showed that inositol supplementation among patients with metabolic diseases significantly decreased triglycerides (SMD - 1.24; 95% CI, - 1.84, - 0.64; P < 0.001), total- (SMD - 1.09; 95% CI, - 1.83, - 0.55; P < 0.001), and LDL-cholesterol levels (SMD - 1.31; 95% CI, - 2.23, - 0.39; P = 0.005). There was no effect of inositol supplementation on HDL-cholesterol levels (SMD 0.20; 95% CI, - 0.27, 0.67; P = 0.40). CONCLUSIONS: Inositol supplementation may result in reduction in triglycerides, total- and LDL-cholesterol levels, but did not affect HDL-cholesterol levels among patients with metabolic diseases. Additional prospective studies regarding the effect of inositol supplementation on lipid profiles in patients with metabolic diseases are necessary.

Burden of traffic accidents among pedestrians of Fars province, southern Iran; estimate of years of life lost in a sample of Iranian population from 2009 to 2013.

PURPOSE: Traffic injuries are among the leading causes of mortality and morbidity worldwide. Pedestrians have been considered as a high-risk group among road users, especially in middle- or low-income communities. This study attempted to determine the burden of pedestrians' fatalities in Fars, the southern province of Iran using years of life lost (YLL) approach. METHODS: The data used in this study were retrieved from Fars Forensic Medicine Organization database on pedestrian traffic accidents. The YLL from 2009 to 2013 was estimated using the method presented by World Health organization. Some epidemiological characteristics of pedestrians' fatalities were analyzed by SPSS. RESULTS: Although YLL among 1000 male pedestrians decreased from 2.5 in 2009 to 1.5 in 2013, it increased from 0.9 to 2.1 among 1000 females during the same period. Higher proportion of death was found in female, illiterate, and married pedestrians (p < 0.001). In addition, mortality was higher in pedestrians living the cities, during daytime, at home, and in hospitals (p < 0.001). CONCLUSION: Consistent with the global trends, burden of pedestrian accidents in Fars was also exceptionally high. Considering the national and cultural aspects of different countries, improving the safety of pedestrians demands a multi-dimensional approach with interventional factors concerning policies, rules, pedestrians, motor vehicles and environmental conditions taken into consideration.

Relationship between religion and school students' road behavior in southern Iran.

PURPOSE: Unsafe behaviors are an important cause of accidents in adolescent age groups. This study was designed to examine the behaviors of adolescent pedestrians in southern Iran. METHODS: This is a descriptive analytical cross-sectional study. The study population consisted of high school students in Shiraz, capital city of Fars Province, Iran. Five hundred and sixteen students were selected by multi-stage sampling. Data were collected by the use of three questionnaires, which included Persian copies of adolescent road user behavior questionnaire (ARBQ), Duke University Religious Index (DUREL), as well as the context and independent variables questionnaire. RESULTS: The results showed that a decrease in dangerous behaviors on the road resulted in an increase in respondents' intrinsic religiosity. Also, engagement in unsafe crossing behavior in the road decreased with increasing respondents' intrinsic religiosity. Another finding showed that female students were less involved in dangerous play and planned protective behaviors on the road. CONCLUSION: Findings clearly indicate that intrinsic religiosity has a significant role in reducing the risky road behaviors of students. Hence, religion may improve road safety in school students' road behavior in Iran.

New use of an old drug: chloroquine reduces viral and ALT levels in HCV non-responders (a randomized, triple-blind, placebo-controlled pilot trial).

Hepatitis C virus (HCV) infection induces autophagy, but the virus assimilates the autophagic response into its own life cycle. Chloroquine (CQ) is an autophagy inhibitor that is clinically used to treat malaria. The aims of this pilot clinical trial were to evaluate the therapeutic potential and short-term safety of CQ in patients with chronic HCV genotype 1, who were unresponsive to a combination of pegylated interferon alpha and ribavirin. Ten non-responders to previous antiviral treatment(s) were randomized to receive either CQ (150 mg daily for 8 weeks) or placebo, and were followed for 4 weeks after CQ therapy. HCV RNA load and plasma alanine transaminase (ALT) levels were measured at baseline, week 4 (initial response), week 8 (end-of-treatment response), and at the end of 12 weeks. A significant decrease in HCV RNA after the treatments (week 8) was observed in all patients in the CQ group (P = 0.04). However, HCV RNA levels increased within 4 weeks after discontinuation of CQ treatment although they were still lower than baseline. In addition, the ALT normalized during treatment in the CQ group. However, this response was also lost after treatment cessation. This study provides preliminary evidence that CQ is possibly a safe treatment option for HCV non-responders.

Genetic Prognostic Factors in Adult Diffuse Gliomas: A 10-Year Experience at a Single Institution.

Gliomas are primary brain lesions involving cerebral structures without well-defined boundaries and constitute the most prevalent central nervous system (CNS) neoplasms. Among gliomas, glioblastoma (GB) is a glioma of the highest grade and is associated with a grim prognosis. We examined how clinical variables and molecular profiles may have affected overall survival (OS) over the past ten years. A retrospective study was conducted at Sina Hospital in Tehran, Iran and examined patients with confirmed glioma diagnoses between 2012 and 2020. We evaluated the correlation between OS in GB patients and sociodemographic as well as clinical factors and molecular profiling based on IDH1, O-6-Methylguanine-DNA Methyltransferase (MGMT), TERTp, and epidermal growth factor receptor (EGFR) amplification (EGFR-amp) status. Kaplan-Meier and multivariate Cox regression models were used to assess patient survival. A total of 178 patients were enrolled in the study. The median OS was 20 months, with a 2-year survival rate of 61.0%. Among the 127 patients with available IDH measurements, 100 (78.7%) exhibited mutated IDH1 (IDH1-mut) tumors. Of the 127 patients with assessed MGMT promoter methylation (MGMTp-met), 89 (70.1%) had MGMT methylated tumors. Mutant TERTp (TERTp-mut) was detected in 20 out of 127 cases (15.7%), while wildtype TERTp (wildtype TERTp-wt) was observed in 107 cases (84.3%). Analyses using multivariable models revealed that age at histological grade (p < 0.0001), adjuvant radiotherapy (p < 0.018), IDH1 status (p < 0.043), and TERT-p status (p < 0.014) were independently associated with OS. Our study demonstrates that patients with higher tumor histological grades who had received adjuvant radiotherapy exhibited IDH1-mut or presented with TERTp-wt experienced improved OS. Besides, an interesting finding showed an association between methylation of MGMTp and TERTp status with tumor location.

Time analysis of fatal traffic accidents in Fars Province of Iran.

OBJECTIVE: To analyze the time factor in road traffic accidents (RTAs) in Fars Province of Iran. METHODS: This study was conducted in Fars Province, Iran from November 22, 2009 to November 21, 2011. Victims'information consisted of age, sex, death toll involving dri- vers or passengers of cars, motorcycles and pedestrians, and site of injury etc. Accidents were analyzed in relation to hour of the day, season of the year, lighting condition including sunrise, sunset, daytime and nighttime. RESULTS: A total of 3 642 deaths (78.3% were males, and the ratio of males to females was about 3.6:1) were studied regarding their autopsy records. There was a steady increase in fatal accidents occurring at midnight to 15:59. The risk of being involved in a fatal traffic accident was higher for those injured between 4:00 to 7:59 than at other times (OR equal to 2.13, 95% CI 1.85-2.44). The greatest number of fatal RTAs took place in summer. Mortalities due to RTA during spring and summer were more pronounced at 20:00 to 23:59 and midnight to 3:59, whereas mortalities in fall and winter were more pronounced from 12:00 to 15:59. CONCLUSION: The high mortality rate of RTA is a major public health problem in Fars Province. Our results indicate that the time is an important factor which contributes to road traffic deaths.

Health-related quality of life variation by socioeconomic status: Evidence from an Iranian population-based study.

BACKGROUND: Health-Related Quality of Life (HRQoL) values based on the accurate and reliable European Quality of Life Five Dimension (EQ-5D) questionnaire gives health-state utilities as a helpful data set for studying socio-demographic and socio-economic inequalities in health status in the general population. We aimed to do a population-based study to see how HRQoL varies by socio-demographics and socioeconomic status (SES). MATERIALS AND METHODS: The study was a cross-sectional population-based study in Shiraz, Iran's southwest. Data was gathered utilizing a personal digital assistant (PDA). A trained interviewer administered the EQ-5D questionnaire to a representative sample of 1036 inhabitants. Principal component analysis (PCA) was used to create SES indices. Because of the skewed distribution, quantile regression was utilized to model the quartiles of HRQoL values. STATA 12.0 was used to perform all statistical analyses. P <0.05 was considered statistically significant. RESULTS: In 1036 study respondents, women had a mean HRQoL of 0.67 ± 0.28, whereas men had a mean HRQoL of 0.78 ± 0.25. Gender and age remained significant in all quartiles of HRQoL value. Participants with insurance showed 0.14 and 0.08 higher HRQoL values in the first and second HRQoL quartiles than those without coverage, respectively. Education [95% CI: 0.034, 0.111)], economy [95% CI: 0.013, 0.077], and assets [95% CI: 0.003, 0.069] all had an impact on HRQoL value in the lowest quintile. CONCLUSION: In all quartiles of HRQoL value, women had lower reported HRQoL than men. Insurance programs aimed at more disadvantaged groups with poorer HRQoL may help to minimize inequity. Education, economics, and assets all had an impact on the lower quartiles of HRQoL value, emphasizing the importance of general policies in determining public health status.

Acute kidney injury in COVID-19 patients receiving remdesivir: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVES: Remdesivir is an antiviral agent with positive effects on the prognosis of Coronavirus Disease (COVID-19). However, there are concerns about the detrimental effects of remdesivir on kidney function which might consequently lead to Acute Kidney Injury (AKI). In this study, we aim to determine whether remdesivir use in COVID-19 patients increases the risk of AKI. METHODS: PubMed, Scopus, Web of Science, the Cochrane Central Register of Controlled Trials, medRxiv, and bioRxiv were systematically searched until July 2022, to find Randomized Clinical Trials (RCT) that evaluated remdesivir for its effect on COVID-19 and provided information on AKI events. A random-effects model meta-analysis was conducted and the certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation. The primary outcomes were AKI as a Serious Adverse Event (SAE) and combined serious and non-serious Adverse Events (AE) due to AKI. RESULTS: This study included 5 RCTs involving 3095 patients. Remdesivir treatment was not associated with a significant change in the risk of AKI classified as SAE (Risk Ratio [RR]: 0.71, 95% Confidence Interval [95% CI] 0.43‒1.18, p = 0.19, low-certainty evidence) and AKI classified as any grade AEs (RR = 0.83, 95% CI 0.52‒1.33, p = 0.44, low-certainty evidence), compared to the control group. CONCLUSION: Our study suggested that remdesivir treatment probably has little or no effect on the risk of AKI in COVID-19 patients.

Sex differences among users of NSAIDs and opioids during COVID-19 Pandemic.

BACKGROUND: Sex-based inequalities in healthcare have been exposed and amplified during the COVID-19 pandemic. However, few studies have reported sex differences in medication utilization and no studies have examined sex differences in prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and opioids utilization. AIM: To compare the utilization patterns of prescribed NSAIDs and opioids between males and females in Manitoba, Canada during the COVID-19 pandemic. METHOD: A cohort of incident and prevalent users of prescribed NSAIDs and opioids was created. Interrupted times series analysis using autoregressive models were used to evaluate the quarterly change in the prevalent and incident users before and after COVID-19 restrictions were applied (first quarter of 2020). RESULTS: COVID-19 restrictions were associated with a significant decrease in the utilization of prescribed NSAIDs and opioids in all users, followed by a revert to the pre-pandemic trends. Among female prevalent and incident NSAIDs users, there was a significant change in trend after COVID-19 restrictions were introduced (ß3 = 0.087 and 0.078, P = 0.023 and 0.028, respectively). However, there was non-significant change in trend among male prevalent and incident NSAIDs and opioids users during the pandemic. CONCLUSION: In this study, a significant sharp decline in the use of prescribed NSAIDs and opioids was shown in both sexes at the onset of the pandemic. However, a significant upward trend is observed in female NSAIDs users as restrictions began to be lifted.

Prescription trends of antiseizure medications before and during the COVID-19 pandemic.

Introduction: Given the lack of evidence on how the COVID-19 pandemic impacted antiseizure medication (ASM) use, we examined the trends of ASMs before and during COVID-19. Methods: We conducted a population-based study using provincial-level health databases from Manitoba, Canada, between 1 June 2016 and 1 March 2021. We used interrupted time series autoregressive models to examine changes in the prevalence and incidence of ASM prescription rates associated with COVID-19 public health restrictions. Results: Among prevalent users, the COVID-19 pandemic led to a significant increase in new-generation ASMs with a percentage change of 0.09% (p = 0.03) and a significant decrease in incidence use of all ASMs with a percentage change of -4.35% (p = 0.04). Significant trend changes were observed in the prevalent use of new-generation ASMs (p = 0.04) and incidence use of all (p = 0.04) and new-generation ASMs (p = 0.02). Gabapentin and clonazepam prescriptions contributed 37% of prevalent and 54% of incident use. Conclusion: With the introduction of public health measures during COVID-19, small but significant changes in the incident and prevalent use of ASM prescriptions were observed. Further studies are needed to examine whether barriers to medication access were associated with potential deterioration in seizure control among patients. Conference presentation: The results from this study have been presented as an oral presentation at the 38th ICPE, International Society of Pharmacoepidemiology (ISPE) annual conference in Copenhagen.

Efficacy and Safety of MAO-B Inhibitors Safinamide and Zonisamide in Parkinson's Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND AND OBJECTIVE: In Parkinson's disease, safinamide and zonisamide are novel monoamine oxidase-B inhibitors with a dual mechanism of action involving the inhibition of sodium and calcium channels and the subsequent release of glutamate. The aim of this systematic review and meta-analysis was to examine the efficacy and safety of both drugs compared with placebo on motor symptoms, cognitive function, and quality of life in patients with Parkinson's disease. METHODS: We searched MEDLINE, EMBASE, Cochrane Central, Scopus, PsycINFO, and trials registries up to March 2023 for randomized controlled trials of adults with Parkinson's disease administered either safinamide or zonisamide and published in English. We excluded single-arm trials or if neither the efficacy nor safety outcomes of interest were reported. Primary outcomes were the change from baseline in Unified Parkinson's Disease Rating Scale section III (UPDRS-III) and serious adverse events. Secondary outcomes included a change from baseline in OFF-time, Parkinson's Disease Questionnaire 39 to evaluate quality of life, and Mini-Mental State Examination for cognitive function assessment. The meta-analysis was conducted using Review Manager 5.4.1. Random-effect models were used to calculate the pooled mean differences (MDs) and risk ratios with 95% confidence intervals (CIs). Subgroup analyses by medication, doses, Parkinson's disease stage, and risk of bias were conducted. We assessed the risk of bias using the Cochrane's risk of bias tool. Sensitivity analysis was conducted, and publication bias were evaluated. This meta-analysis was not externally funded, and the protocol is available on the Open Science Framework Registration ( https://doi.org/10.17605/OSF.IO/AMNP5 ). RESULTS: Of 3570 screened citations, 16 trials met inclusion criteria (4314 patients with Parkinson's disease). Ten safinamide trials were conducted in several countries. Six zonisamide trials were included, five of which were conducted in Japan and one in India. UPDRS Part III scores were significantly lower with both monoamine oxidase-B inhibitors than with placebo (MD = -  2.18; 95% CI -  2.88 to -  1.49; I 2 =63%; n = 14 studies). A subgroup analysis showed a significant improvement in UPDRS-III in safinamide (MD = -  2.10; 95% CI -  3.09 to -  1.11; I2 = 71%; n = 8 studies) and zonisamide (MD = -  2.31; 95% CI -  3.35 to -  1.27; I2 = 52%; n = 6 studies) compared with placebo. Monoamine oxidase-B inhibitors significantly decreased OFF-time compared with placebo. No significant differences in cognitive function (Mini-Mental State Examination), whereas an improvement in quality of life (Parkinson's Disease Questionnaire 39 scores) was observed. There was no significant difference in incidence rates of serious adverse events among all examined doses of zonisamide and safinamide compared with placebo. Two trials were reported as a high risk of bias and sensitivity analyses confirmed the primary analysis results. CONCLUSIONS: Evidence suggests that novel monoamine oxidase-B inhibitors not only improve motor symptoms but also enhance patients' quality of life. The meta-analysis showed that both medications have a similar safety profile to placebo with regard to serious adverse events. The overall findings emphasize the effectiveness of safinamide and zonisamide in the treatment of Parkinson's disease as adjunct therapy. Further long-term studies examining the impact of these medications on motor and non-motor symptoms are necessary.

Preterm birth and stillbirth rates associated with socioeconomic disparities during COVID-19 pandemic: a population-based cross-sectional study.

BACKGROUND: Conflicting evidence exists on the impact of the COVID-19 pandemic restrictions on preterm birth (PTB) and stillbirth rates. We aimed to evaluate changes in PTB and stillbirth rates before and during the pandemic period and assess the potential effect modification of socioeconomic status (SES). METHODS: Using the linked administrative health databases from Manitoba, Canada, we conducted a cross-sectional study among all pregnant women, comparing 3.5 years pre-pandemic (1 October 2016 to 29 February 2020) to the first year of the pandemic (1 March 2020 to 31 March 2021). We used generalised linear models to assess the quarterly rates of PTB (<37 weeks) and stillbirths. We calculated the predicted trends based on pre-pandemic period data. Finally, we evaluated the PTB and stillbirth rates among lower and higher SES pregnant women (average annual household income) using subgroup analysis and interaction models. RESULTS: We examined 70 931 pregnancies in Manitoba during the study period. The risk of PTB increased by 7.7% (95%CI 1.01 to 1.13) and stillbirths by 33% (95% CI 1.08 to 1.64) during the pandemic period. Following COVID-19 restrictions implemented in March 2020, there were increases in the quarterly rates of both PTB (immediate increase (ß2)=1.37; p=0.0247) and stillbirths (immediate increase (ß2)=0.12; p=0.4434). Among the lower income groups, the pandemic restrictions resulted in an immediate relative increase in PTB and stillbirth rates by 20.12% (immediate increase (ß2)=3.17; p=0.0057) and 27.19% (immediate increase (ß2)=0.48; p=0.0852). However, over the pandemic, the overall PTB rate significantly decreased as a rebound effect by 0.85% per quarter (p=0.0004), whereas the overall stillbirth rate did not decrease significantly (slope decrease (ß3) =-0.01; p=0.8296) compared with the pre-pandemic period. The quarterly rates during the pandemic among the higher income group decreased by 0.39% (p=0.1296) for PTB and increased by 0.07% (p=0.1565) for stillbirth. We observed an effect modification by SES for PTB rates (p=0.047). CONCLUSION: While the onset of COVID-19 pandemic restrictions was not associated with significant effects on stillbirth rates, we observed an immediate and rebound effect on PTB rates. The impact of COVID-19 on preterm birth was dependent on SES, with higher influence on families with lower SES. Further studies are needed to detect future trend changes during pandemic waves after 2021 and assess potential underlying mechanisms.

Evaluation of the Factors Associated with Prescribed and Non-Prescribed Medicine: A Population-Based Study.

OBJECTIVES: Several factors influence medication patterns. The purpose of this study was to look into the role of social determinants in the use of prescribed and non-prescribed medications in a population-based setting of people over 18 in a southern metropolis of Iran (Shiraz) for 2 years. STUDY DESIGN: Prospective population-based cross-sectional. METHODS: This descriptive and cross-sectional survey was done in 2018-2020. A total of 1016 participants were randomly selected based on their postal codes and recruited to the study. The demographic characteristics (age, sex, and education), social profiles (insurance, supplementary insurance, health status, and daily exercise plan), and outpatient visits (family/general physician or specialist/ subspecialist) were recorded by gathering sheets. Descriptive analyses and multinomial logistic analyses were carried out using SPSS software. RESULTS: The medication use pattern was classified into three categories: non-prescribed type I, non-prescribed type II, and prescribed. The mean age of participants was 45.54 ± 15.82 years. The results indicated that most of them took their medication without a prescription (non-prescribed type II). However, people who had insurance and referred to a family physician commonly used the prescribed medications. This study also found that patients who visited a family doctor or a general practitioner used fewer prescribed drugs than those who visited a specialist. CONCLUSION: This study describes social determinants as additional effective factors in health services that influence the use of prescribed and non-prescribed medications in Shiraz. These evidence- based findings can help policymakers to plan the best programs.

Fatal motorcycle accidents in Fars Province, Iran: a community-based survey.

OBJECTIVE: To identify the main characteristics of victims of motorcycle accidents in Fars Province, Iran. METHODS: This cross-sectional study was conducted in Fars Province which has the fourth largest population of all 31 provinces in Iran from March 2009 to June 2010. We included data from all 542 recorded cases of fatalities due to motor vehicle accidents. Data were recorded from the forensic medicine registry consisting of demographic and accident-related information. Demographic information consisted of name, age, sex, status of fatal victim (motorcycle driver vs passenger) and educational level. RESULTS: Of the 2 345 autopsy records from the forensic medicine archives, 542 (23.1%) gave the cause of death as motor vehicle accidents. Mean age of these victims was (31.4+/-6.5) years, and the male to female ratio was 28. Head injury was the most common cause of death in these victims, and overall they tended to have a low level of education. Motorcycle accidents frequently involved younger age groups (15-35 years), and head trauma related with non-use of a helmet was the most common cause of death. CONCLUSIONS: Head injury is frequent among victims in the province we studied. This situation may be related to the victims' low socioeconomic status and little education regarding traffic laws leading to speeding and disregard of these laws along with their weak enforcement.

Epidemiological characteristics of fatal pedestrian accidents in Fars Province of Iran: a community-based survey.

OBJECTIVE: To determine the epidemiological characteristics of fatal pedestrian accidents in Fars Province of Iran. METHODS: This cross-sectional study was conducted in Fars Province of Iran during a 29-month period from March 2009 to July 2011. The data were from the Fars Forensic Medicine Registry. In 4 923 recorded road traffic accident fatalities, 971 deaths were due to pedestrian accidents. The demographic and accident-related information were analyzed by SPSS version 11.5. P value less than 0.05 was considered significant. RESULTS: The mean age of decedents was (47.2+/-26.2) years, ranging from 6 months to 103 years old. Males accounted for 69.8% of all deaths. Fatal accidents were most common in September; 56.1% of the fatal injuries occurred on intracity roads and 33.1% on extracity roads. Fatal head injuries were present in 60.54% of cases. Evaluation of the injury site and the cause of death found that they were significantly associated with age, interval between injury and death. Besides, the type of roads played an important role in mortality. CONCLUSION: Although the clinical management of trauma patients has been improved in our country in the recent decade, decreasing the burden of injuries needs coordination among trauma system organizations.

Utilization of Pharmacokinetic/Pharmacodynamic Modeling in Pharmacoepidemiological Studies: A Systematic Review on Antiarrhythmic and Glucose-Lowering Medicines.

Introduction: In human pharmacology, there are two important scientific branches: clinical pharmacology and pharmacoepidemiology. Pharmacokinetic/pharmacodynamic (PK/PD) modeling is important in preclinical studies and randomized control trials. However, it is rarely used in pharmacoepidemiological studies on the effectiveness and medication safety where the target population is heterogeneous and followed for longer periods. The objective of this literature review was to investigate how far PK/PD modeling is utilized in observational studies on glucose-lowering and antiarrhythmic drugs. Method: A systematic literature search of MEDLINE, Embase, and Web of Science was conducted from January 2010 to 21 February 2020. To calculate the utilization of PK/PD modeling in observational studies, we followed two search strategies. In the first strategy, we screened a 1% random set from 95,672 studies on glucose-lowering and antiarrhythmic drugs on inclusion criteria. In the second strategy, we evaluated the percentage of studies in which PK/PD modeling techniques were utilized. Subsequently, we divided the total number of included studies in the second search strategy by the total number of eligible studies in the first search strategy. Results: The comprehensive search of databases and the manual search of included references yielded a total of 29 studies included in the qualitative synthesis of our systematic review. Nearly all 29 studies had utilized a PK model, whereas only two studies developed a PD model to evaluate the effectiveness of medications. In total, 16 out of 29 studies (55.1%) used a PK/PD model in the observational setting to study effect modification. The utilization of PK/PD modeling in observational studies was calculated as 0.42%. Conclusion: PK/PD modeling techniques were substantially underutilized in observational studies of antiarrhythmic and glucose-lowering drugs during the past decade.