Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

BACKGROUND: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017. METHODS: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence. RESULTS: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]). CONCLUSION: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.

The utility of serum glucose potassium ratio as a predictive factor for haemorrhagic transformation, stroke recurrence, and mortality among ischemic stroke patients.

Background and Objective: Glucose-Potassium Ratio (GPR) has emerged as a biomarker in several pathophysiological conditions. However, the association between GPR and long-term outcomes in stroke patients has not been investigated. Our study evaluated the applicability of baseline GPR as a predictive prognostic tool for clinical outcomes in ischemic stroke patients. Methods: The multicenter retrospective cohort study included acute-subacute adult ischemic stroke patients who had their baseline serum GPR levels measured. Eligible patients were categorized into two sub-cohorts based on the baseline GPR levels (<1.67 vs. ≥ 1.67). The primary outcome was the incidence of 30-day hemorrhagic transformation, while stroke recurrence, and all-cause mortality within twelve months, were considered secondary. Results: Among 4083 patients screened, 1047 were included in the current study. In comparison with GPR < 1.67 group, patients with ≥ 1.67 GPR had a significantly higher ratio of all-cause mortality within twelve months (aHR 2.07 [95 % CI 1.21-3.75] p = 0.01), and higher ratio of 30-day hemorrhagic transformation but failed to reach the statistical significance (aHR 1.60 [95 % CI 0.95-2.79], p = 0.08). Conclusion: Overall, baseline GPR serum is an independent predictor of all-cause mortality within twelve months in patients with acute and subacute ischemic stroke. Further clinical studies are necessary to validate these findings.

Outcomes and complications of patients with cerebral venous thrombosis: a retrospective study.

OBJECTIVES: To assess outcomes and complications of patients with cerebral venous thrombosis (CVT). METHODS: This multicenter retrospective study was conducted at 2 health care centers in Saudi Arabia and Oman. Adult patients diagnosed with CVT in radiological imaging between 2006 and 2020 were included. Data were collected from medical records and analyzed using the software IBM® SPSS version 22. Neurological disability occurring after CVT was graded according to the modified Rankin scale (mRS). RESULTS: The study included 103 patients, of which the majority (68%) were female. The mean age was 39.12±12.96 years. Two-thirds of patients received low-molecular-weight heparin (LMWH) in acute treatment, while 76% of discharged patients used warfarin. The majority of patients had no or mild neurological disability during follow-up, and 6 patients had an mRS score ≥3, implying significant neurological disability. There were 55 patients (52.3%) who had complications from CVT, including seizures in 17 (16.5%) patients and one mortality. Follow-up imaging of 55 patients showed complete thrombus resolution in 20 patients (36%). CONCLUSION: Anticoagulation is the mainstay treatment for CVT patients. Approximately half of patients experience complications. Prospective studies are needed to assess the long-term neurological outcomes in such patients.

Gut microbiota analyses of inflammatory bowel diseases from a representative Saudi population.

BACKGROUND: Crohn's diseases and ulcerative colitis, both of which are chronic immune-mediated disorders of the gastrointestinal tract are major contributors to the overarching Inflammatory bowel diseases. It has become increasingly evident that the pathological processes of IBDs results from interactions between genetic and environmental factors, which can skew immune responses against normal intestinal flora. METHODS: The aim of this study is to assess and analyze the taxa diversity and relative abundances in CD and UC in the Saudi population. We utilized a sequencing strategy that targets all variable regions in the 16 S rRNA gene using the Swift Amplicon 16 S rRNA Panel on Illumina NovaSeq 6000. RESULTS: The composition of stool 16 S rRNA was analyzed from 219 patients with inflammatory bowel disease and from 124 healthy controls. We quantified the abundance of microbial communities to examine any significant differences between subpopulations of samples. At the genus level, two genera in particular, Veillonella and Lachnoclostridium showed significant association with CD versus controls. There were significant differences between subjects with CD versus UC, with the top differential genera spanning Akkermansia, Harryflintia, Maegamonas and Phascolarctobacterium. Furthermore, statistically significant taxa diversity in microbiome composition was observed within the UC and CD groups. CONCLUSIONS: In conclusion we have shown that there are significant differences in gut microbiota between UC, CD and controls in a Saudi Arabian inflammatory bowel disease cohort. This reinforces the need for further studies in large populations that are ethnically and geographically diverse. In addition, our results show the potential to develop classifiers that may have add additional richness of context to clinical diagnosis of UC and CD with larger inflammatory bowel disease cohorts.

The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis.

PURPOSE: The Saudi Food and Drug Authority (SFDA) added pregabalin to the list of controlled substances in December 2017 to minimize the risk of its possible abuse and misuse. This study was aimed at assessing the impact of this decision on the overall use of pregabalin in Saudi Arabia and in comparison with drugs prescribed to treat neuropathic pain (i.e., vs. gabapentin, tramadol, duloxetine, and amitriptyline). METHODS: This was an interrupted time-series analysis of the Saudi quarterly sale data of the study drugs from October/2015 to September/2020. These data were obtained from IQVIA and were converted into use estimates (defined daily dose per 1000 inhabitant-days [DDD/TID]). Segmented regression models were conducted to assess the direct (level) and prolonged (trend) changes in use data after the decision. All analyses were completed using RStudio Version 1.4.1103. RESULTS: Before the SFDA's decision, there was an increased quarter-to-quarter use of pregabalin (DDD/TID: 0.16; 95% confidence interval [CI] 0.04 to 0.28). Pregabalin overall use dropped sharply by -1.85 DDD/TID (95% CI -2.71 to -0.99) directly after the decision with a prolonged quarter-to-quarter declining effect (DDD/TID: -0.22, CI to -0.37 to -0.05). The decision was associated with a direct increase in the use of gabapentin by 0.62 DDD/TID (95% CI 0.52-0.72) without any impact on the use of other drugs. CONCLUSIONS: The results of our study showed that the SFDA decision was associated with a decrease in the overall use of pregabalin, which may help minimize the risk of its abuse and misuse.

Well Performance Classification and Prediction: Deep Learning and Machine Learning Long Term Regression Experiments on Oil, Gas, and Water Production.

In the oil and gas industries, predicting and classifying oil and gas production for hydrocarbon wells is difficult. Most oil and gas companies use reservoir simulation software to predict future oil and gas production and devise optimum field development plans. However, this process costs an immense number of resources and is time consuming. Each reservoir prediction experiment needs tens or hundreds of simulation runs, taking several hours or days to finish. In this paper, we attempt to overcome these issues by creating machine learning and deep learning models to expedite the process of forecasting oil and gas production. The dataset was provided by the leading oil producer, Saudi Aramco. Our approach reduced the time costs to a worst-case of a few minutes. Our study covered eight different ML and DL experiments and achieved its most outstanding R2 scores of 0.96 for XGBoost, 0.97 for ANN, and 0.98 for RNN over the other experiments.

Analyzing the U.S. Post-marketing safety surveillance of COVID-19 vaccines.

INTRODUCTION: Since December 2020, three COVID-19 vaccines have been authorized in the United States (U.S.) and were proceeded by large immunization programs. The aim of this study was to characterize the U.S. post-marketing safety (PMS) profiles of these vaccines with an in-depth analysis of mortality data. METHODS: This was a retrospective database analysis study. Details of the U.S. PMS reports (15 December 2020 to 19 March 2021) of the three vaccines (Pfizer-BioNTech, Moderna, and Janssen Ad26.COV2.S) were retrieved from the U.S. Vaccine Adverse Event Reporting System (VAERS). A descriptive analysis was conducted to characterize the reported adverse events (AEs). A comparative (Pfizer-BioNTech vs. Moderna) analysis of mortality was conducted. The mean count ratio of death between the two vaccines was estimated using a negative binomial regression model adjusting for the measured confounders. RESULTS: A total of 44,451 AE reports were retrieved (corresponding to 0.05% of the U.S. population who received at least one dose). The most commonly reported AEs were injection site reactions (30.4% of the reports), pain (reported in 26.7% of the reports), and headache (18.6% of the reports). Serious AEs were reported in only 14.6% of the reports with 4,108 hospitalizations. The total number of deaths was 1,919 with a mean count ratio of Moderna (n = 997) vs. Pfizer-BioNTech (n = 899) of 1.07 (95% confidence interval 0.86 to 1.33). CONCLUSIONS: The vast majority of PMS AEs in the U.S. were non-serious, and the number of serious AEs is very low given the total number of vaccinated U.S. population.

Optical comparison between micro-CT and OCT in imaging of marginal composite adaptation: Observational study.

Dental composite is the most used aesthetic restorative biomaterial worldwide. However, it undergoes polymerisation shrinkage that could lead to loss of the interfacial seal between tooth and resin in some circumstances. This demands high-resolution imaging technologies to detect these defects. This study carried out a comparison between microcomputed tomography (micro-CT; Shimadzu, Japan) and swept-source optical coherence tomography (SS-OCT; Santec, Japan) in the detection of marginal adaptation defects at the tooth-resin interface. Unlike in micro-CT, it was possible to outline interfacial gaps along with tooth-resin interfaces with SS-OCT, which was attributed to the Fresnel diffraction of light. This in vitro comparison demonstrates SS-OCT has great potential in dental imaging to effectively assess dental composite adaptation and marginal defects when high resolution is desired in real time. LAY DESCRIPTION: Detection of tooth-colored restoration defects had been assessed by different radiographic methods. However, most of these methods are either invasive or suffer from low-resolution. In this study, a comparison has been carried out between two different high-resolution imaging systems; microcomputed tomography and optical coherence tomography, to explore their potentials in detecting restorations defects. The results showed optical coherence tomography has a great accuracy in locating the underlying defects when the obtained images were validated against confocal laser scanning microscopy images.

Rivaroxaban was found to be noninferior to warfarin in routine clinical care: A retrospective noninferiority cohort replication study.

PURPOSE: To compare the effectiveness and safety of a drug in daily practice with the outcomes of a target non-inferiority trial by rigorously mimickingin an observational study the trial's design features. METHODS: This cohort study was conducted using the British Clinical Practice Research Datalink (CPRD) to emulate the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial. Patients with atrial fibrillation who were newly prescribed (>=12 months of no use) either rivaroxaban or warfarinfrom October 2008 to December 2017 were included. Non-inferiority of rivaroxaban to warfarin in the prevention of stroke or systemic embolism was assessed in different analysis populations (intention-to-treat [ITT], per-protocol [PP], and as-treated populations) using a hazardratio (HR) of 1.46 as the non-inferiority margin. Major bleeding (safety outcome) was also assessed and compared to that of the target trial. All outcomes were analyzed using Cox-proportional hazard analyses. RESULTS: We included 25,473 incident users of rivaroxaban (n=4,008) or warfarin(n=21,465). Similar to the trial, non-inferiority in the primary out come was demonstrated in all three analysis populations: HR=1.04 (95%CI 0.84 to 1.30) (ITT), HR=0.98 (95%CI 0.70 to 1.38) (PP), and HR=1.11 (95%CI 0.86 to 1.42) (as-treated). Risk of major bleeding was also similar to the target trial. CONCLUSION: The results of this study provide supportive evidence to the effectiveness of rivaroxaban and adds knowledge on the usefulness of emulating a non-inferiority trial to assess drug effectiveness.

Effect of self-etch adhesives on the internal adaptation of composite restoration: a CP-OCT Study.

Despite improvements in dental adhesive materials, internal adaptation remains a challenge in bonded restorations. The aim of this study was to compare microgaps and internal floor adaptation between two different self-etch adhesives in class-V cavities using cross-polarization optical coherence tomography (CP-OCT). In this in vitro study, standardized round class-V cavities were prepared in 20 non-carious human upper central incisor teeth. They were randomly divided into two groups, TN and SE, with each group receiving a different dental adhesive. In TN group, the adhesive used was all-in-one Tetric N-Bond Self-Etch (TN; Ivoclar/Vivadent, Liechtenstein), while SE group was bonded with two-step self-etch Clearfil SE Bond 2 adhesive (SE; Kuraray Noritake Dental Inc, Japan). The prepared cavities were restored with flowable composite and then stored in distilled water for 24 h. Next, they were immersed in silver nitrate, followed by immersion in a photo-developing solution. Optical comparison was carried out by CP-OCT to assess microgaps and composite adaptation at the cavity floor. A Mann-Whitney test was applied to the data, which showed a statistically significant difference in composite adaptation among the two groups (p < 0.001) with the SE group showing superior adaptation. CP-OCT is a reliable tool for non-invasive imaging that gives an insight into composite performance. Better adaptation was found with the two-step self-adhesive for the composite used in this study.

Gender differences in the association of ELMO1 genetic variants with type 2 diabetes in Tunisian Arabs.

PURPOSE: Polymorphisms of the engulfment and cell motility 1 (ELMO1) gene were recently associated with type 2 diabetes (T2DM) and its complications. We investigated the association of rs10255208, rs7782979, and rs2041801 ELMO1 gene variants with T2DM in Tunisian Arabs. METHODS: Subjects comprised 900 T2DM patients and 600 normoglycemic controls. ELMO1 genotyping was done by PCR-RFLP; the contribution of ELMO1 variants to T2DM was analyzed by Haploview and regression analysis. RESULTS: Minor allele frequencies of rs7782979 and rs10255208 ELMO1 variants were significantly higher among unselected T2DM cases than controls, and significant differences in the distribution of rs7782979 genotypes were seen between T2DM cases and control subjects, which was seen in male but not female subjects. Three-locus ELMO1 haplotype analysis identified haplotype GAA to be positively associated, and haplotypes GCA, AAA, and GCG to be negatively associated with T2DM. The distribution of these haplotypes was gender-dependent for some (GCA, GCG, AAG), and gender-independent for others (GAA, AAA). This translated into altered risk of T2DM in male or female subjects, which persisted after adjusting for BMI, systolic and diastolic blood pressure, and serum lipid profile. CONCLUSION: These results confirm role for ELMO1 as T2DM susceptibility locus, which appears to be gender-dependent.

Defining the noninferiority margin and analysing noninferiority: An overview.

Noninferiority trials are used to assess whether the effect of a new drug is not worse than an active comparator by more than a noninferiority margin. If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one of the most challenging steps in the design of noninferiority trials. Regulators recommend that the margin should be defined based on the historical evidence of the active comparator (the latter is often the well-established standard treatment of the disease), which can be performed by different approaches. There are several factors and assumptions that need to be accounted for during the process of defining the margin and during the analysis of noninferiority. Three methods are commonly used to analyse noninferiority trials: the fixed-margin method; the point-estimate method; and the synthesis method. This article provides an overview of analysing noninferiority and choosing the noninferiority margin.

Prevalence of sexual dysfunction in saudi women with Type 2 diabetes: Is it affected by age, glycemic control or obesity?

OBJECTIVE: Sexual dysfunction (SD), as a diabetes mellitus (DM)-related complication, is common among patients having diabetes. This study aimed to ascertain the prevalence of SD in Saudi women with type 2 DM and to determine whether age, glycemic control, and obesity are associated with SD or not. METHODS: A total of 275 Saudi women with type 2 diabetes took part in this cross-sectional study and filled out the Female Sexual Function Index through a fill-coded questionnaire in primary care clinics in King Khalid University Hospital, Riyadh, in the period between January 2013 and May 2013. The level of glycosylated hemoglobin and the body mass index were assessed to evaluate the DM control status and obesity among the patients. RESULTS: SD was reported by 88.7% of the Saudi women with type 2 diabetes. The results showed a significant association between the presence of SD and the increase in age of patients at 92% in the age group above 50 years. Glycemic control did not show a significant association with SD. The obesity factor showed a slight increase in SD by weight, but it was not statistically significant. CONCLUSION: The prevalence of SD among the Saudi women having type 2 diabetes is high and increases with age. No association was found between SD and glycemic control.

Ultrastructural features of dentinoenamel junction revealed by focused gallium ion beam milling.

To take full advantage of focused ion beam (FIB) in preparation of ultrathin sections of biological tissues, we have used a cryo-milling process. In this study, extracted human teeth were scanned by optical coherence tomography to inspect the samples for intactness and to determine the area of interest. Then, the selected area of interest was cross-sectioned for examination under a confocal laser scanning microscope to determine the target location of the dentinoenamel junction (DEJ) that was later milled by cryo-FIB at preset parameters, followed by transmission electron microscope examination of the final sliced specimens for ultrastructural characterization. The proposed technique was able to outline the DEJ and to identify the different tooth layers in a single section, without artefacts or tissue damage. The DEJ was outlined as fine longitudinal projections intermingling between the solid electron-dense enamel and intricate electron-lucent hollow dentin. In conclusion, this study has shown the great potential of cryo-FIB in handling different biological tissues having different physical properties, with great precision and accuracy and minimum artefacts.

Characterization of transparent dentin in attrited teeth using optical coherence tomography.

Attrition and wear of tooth surface occur with aging and result in loss of enamel, with exposure and histological changes in dentin. Dealing with attrited teeth and restoration of the lost tissue are clinically challenging. The main objective of this study is to characterize the exposed transparent dentin in the occlusal surface of attrited teeth by optical coherence tomography (OCT). Naturally attrited, extracted human teeth with occlusal-transparent dentin were investigated in comparison to sound and carious teeth. The teeth were subjected to OCT imaging and then cross-sectioned and polished. OCT B-scans were compared to light microscopy images of the same cross section. In OCT images, some changes were evident at the transparent dentin in attrited teeth. An OCT attenuation coefficient parameter (µ t) was derived based on the Beer-Lambert law as a function of backscatter signal slope. The mean values of µ t were 1.05 ± 0.3, 2.23 ± 0.4, and 0.61 ± 0.27 mm(-1) for sound, carious, and transparent dentins, respectively. One-way ANOVA with Tukey's post-hoc showed a significant difference between groups (p < 0.05). Physiological changes in transparent dentin that involve deposition of mineral casts in the dentinal tubules lead to lower attenuation of OCT signal. OCT has a potential role to detect transparent dentin on the surface of attrited teeth and can be used in the future as a clinical adjunct tool.

A variant of perilunate dislocation: A case report and literature review.

Perilunate dislocation is a rare carpal dislocation, which are predominantly trans-styloid and trans-scaphoid. This type of fracture dislocation is seen due to axial loading of a hyperextended ulnar-deviated wrist. This can result in the disruption of the scapholunate, lunocapitate, and lunotriquetral ligaments. The lunate may dislocate volar or dorsal to the other carpal bones. Herein, we have reported a case of trans-styloid, trans-scaphoid perilunate fracture dislocation with carpal tunnel syndrome, which has never been reported in the literature. A 38-year-old construction worker presented with a swollen hand and signs of carpal tunnel syndrome. The patient was diagnosed with perilunate fracture dislocation after a through clinical and radiological assessment. The scaphoid had invaginated into the radial styloid and demonstrated a comminuted fracture pattern. Volar lunate displacement was identified, and the patient demonstrated signs of carpal tunnel syndrome, which is not a common presentation. Open reduction with ligament repair was performed to minimize jeopardizing the hand function. Spelt tea cup sign is a diagnostic for perilunate dislocation. Operative exploration and reduction is imperative for failed closed lunate dislocation reduction to minimizes ongoing soft tissue jeopardy. Moreover, carpal tunnel release is indicated in the present of symptomatic carpal tunnel syndrome. To our knowledge, only a few cases of trans-styloid, trans-scaphoid perilunate dislocation with neurological deficit have been reported.

Correlation of Anemia Due to Poor Iron Status With Obesity at King Fahad Medical City, Riyadh, Saudi Arabia.

Background Saudi Arabia has a high prevalence of chronic diseases such as obesity. Moreover, iron deficiency anemia (IDA) in developing countries is the most prevalent type of anemia. This study aims to assess the correlation between anemia related to poor iron status and obesity. Methods A cross-sectional observational study was conducted at the obesity center in King Fahad Medical City, Saudi Arabia, from April to September 2020. Two hundred and forty participants were needed to be included in the study. The data was gathered by utilizing a designed data collection form. Socio-demographic data, weight and height, questions related to the history of anemia, and gynecological data (for females) were collected. The data was analyzed using SPSS (Statistical Package for Social Science) version 28.0. Descriptive statistics were used to present numerical and categorical data and a Chi-square test was conducted to assess the correlation between categorical variables. Informed written consent was obtained from all participants and ethical approval was obtained from the Ethical Board Committee in King Fahad Medical City. Results The study included 240 participants. Two-thirds of the study population are females (64.6%), 66.7% are married, and 65.8% have obesity. Almost one-half of the study population (46%, N=128) was diagnosed with IDA with malnourishment being the most common reason for IDA (88.2%). The results indicated a correlation between obesity and the prevalence of IDA. The prevalence of IDA among participants with obesity (60.4%) was significantly higher compared to non-obese participants (39.5%), p=0.002. The study found that females and underweight individuals have a higher prevalence of IDA (p<0.001). Conclusion Results of the present study suggest that obesity could be associated with a risk of IDA. In addition, Saudi women could be more prone to IDA than men. Further prospective controlled studies among diverse populations in Saudi Arabia including laboratory assessment of inflammatory markers and iron status are required to better understand the correlation between obesity and IDA.

Concurrent Vibrio cholerae O1 Meningitis and Intracranial Lesions in a Patient With Sickle Cell Disease: A Case Report.

Cholera meningitis is a rare complication of Vibrio cholerae (V. cholerae) infection. We present a case of cholera meningitis caused by toxigenic V. cholerae O1 in a 34-year-old male with sickle cell disease (SCD). The patient presented with fever, diarrhea, and altered mental status. Cerebrospinal fluid (CSF) analysis showed 5,231 cells/µL (53.9% neutrophils), a protein level of 462 mg/dL, and a glycorrhachia level of 26 mg/dL. V. cholerae O1 was isolated on CSF culture. Despite the patient undergoing antimicrobial therapy, brain imaging revealed basal ganglia ring-enhancing lesions suggestive of tuberculomas. Antituberculosis treatment and steroids led to clinical improvement. This report highlights the need to consider V. cholerae meningitis in patients with SCD who present with diarrhea and altered mental status. Prompt diagnosis and appropriate antimicrobial therapy are keys to improving patient outcomes.

Awareness and attitudes towards eye donation among medical and allied health students in Jeddah, Saudi Arabia.

Background: Many national studies in Saudi Arabia have revealed a lack of knowledge about eye donation. The current study assessed awareness and attitudes towards eye donation among health faculty students in Jeddah, Saudi Arabia. It aims to increase their awareness as future healthcare providers are expected to raise general awareness to attain more local corneal donations. Methods: A cross-sectional study including 1,060 health faculty students was conducted at King Abdulaziz University. Data were collected through an online questionnaire that covered participants' demographics, academic year, knowledge, and attitudes regarding eye donation. Results: Thirty-five percent of students had heard about eye donation, with the most common sources of information being social media (29%) and health workers (24%). Most respondents, 61% (n = 643), indicated willingness to donate their eyes after death. Of these respondents, 93% (n = 986), 6.8% (n = 72), and 0.2% (n = 2) had poor, fair, and good knowledge levels, respectively. A total of 66% (n = 696) and 34% (n = 364) had negative and positive attitudes, respectively. Conclusion: Students in this study showed low levels of knowledge and negative attitudes about eye donation. Students should be adequately educated about the significance of eye donation.

Parental Knowledge, Attitudes, and Practices Towards Pediatric Ear Infections in the Makkah Region of Saudi Arabia: A Cross-Sectional Study.

BACKGROUND:  Pediatric ear infections constitute a significant public health concern worldwide, adversely impacting children's health and well-being. Parents play a crucial role in prevention, ensuring timely healthcare access, and therefore minimizing potential complications. This study aims to assess parental knowledge, attitudes, and practices towards pediatric ear infections in Makkah region. METHODOLOGY:  A descriptive cross-sectional study was conducted among Saudi parents who were ≥18 years old and lived in Makkah region. Convenience sampling was used to recruit 319 participants through social media platforms; data were collected from June to September 2023 via an online self-administered questionnaire. The questionnaire assessed sociodemographic characteristics, along with knowledge, attitudes, and practices related to pediatric ear infections. RESULTS:  A total of 319 parents were included in the study. The majority of the participants were female 228 (71.5%), and 208 (65.2%) had a university education level. The most common age groups were 18-30 years and 31-40 years. More than half of the participants (167, 52.4%) demonstrated adequate knowledge regarding pediatric ear infections. Positive attitudes and practices were reported by 183 (57.4%) and 285 (89.3%) of participants, respectively. Adequate knowledge was significantly higher among participants with younger ages (p<0.05). It was found that having a younger age (18-30 years) was an independent predictor of good knowledge (OR: 1.26 (1.96-3.65), p=0.009) and positive practice (OR: 1.53 (1.01-2.33), p=0.045). CONCLUSION:  We found that the majority of parents in Makkah region had a good level of knowledge regarding childhood ear infections, with an overall positive attitude and practice. The study revealed that younger parents had superior knowledge and younger age was an independent predictor for good knowledge and positive attitude.