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Inappropriate antibiotic (ATB) prescriptions are a threat to patients, leading to adverse drug reactions, bacterial resistance, and subsequently, elevated hospital costs. Our aim was to evaluate ATB prescriptions in an emergency department of a tertiary care facility. A cross-sectional study was conducted by reviewing charts of patients complaining of infections. Patient characteristics (age, sex, weight, allergy, infection type) and prescription characteristics (class, dose, frequency, duration) were evaluated for appropriateness based on the AHFS Drug Information and the Drug Information Handbook. Descriptive and analytic statistics were applied. Sample with equal sex distribution constituted of 5,752 cases: adults (≥15 years) =61% and pediatrics (<15 years) =39%. Around 55% complained of respiratory tract infections, 25% urinary tract infections (UTIs), and 20% others. Broad-spectrum coverage ATBs were prescribed for 76% of the cases. Before the prescription, 82% of pediatrics had their weight taken, while 18% had their weight estimated. Allergy checking was done in 8% only. Prevalence of inappropriate ATB prescriptions with at least one type of error was 46.2% (pediatrics =58% and adults =39%). Errors were in ATB selection (2%), dosage (22%), frequency (4%), and duration (29%). Dosage and duration errors were significantly predominant among pediatrics (P<0.001 and P<0.0001, respectively). Selection error was higher among adults (P=0.001). Age stratification and binary logistic regression were applied. Significant predictors of inappropriate prescriptions were associated with: 1) cephalosporin prescriptions (adults: P<0.001, adjusted odds ratio [adj OR] =3.31) (pediatrics: P<0.001, adj OR =4.12) compared to penicillin; 2) UTIs (adults: P<0.001, adj OR =2.78) (pediatrics: P=0.039, adj OR =0.73) compared to respiratory tract infections; 3) obtaining weight for pediatrics before the prescription of ATB (P<0.001, adj OR =1.83) compared to those whose weight was estimated; and 4) broad-spectrum ATBs in adults (P=0.002, adj OR =0.67). Prevalence of ATB prescription errors in this emergency department was generally high and was particularly common with cephalosporin, narrow-spectrum ATBs, and UTI infections.

The behavior of the general public and the adoption of precautionary measures during a pandemic determine the fate of the country in the absence of any specific cure. This study aimed to determine the public attitude and behavior responses to the COVID-19 pandemic in Saudi Arabia during movement restrictions, and the predictors of behavioral responses. A community-based cross-sectional study of 2470 adult individuals in Saudi Arabia, 17-29 April 2020 was conducted via Survey Monkey, using an anonymous validated e-questionnaire. Data were collected on demographic characteristics, COVID-19-related attitudes, and behavioral responses in terms of; precautionary measures, preparedness, and self-quarantine activities, to be responded to by 4-point Likert scales. Multiple linear regression analyses were performed to identify the significant predictors of compliance with different behaviors. Significance was considered at p<0.05. Participants reported positive attitudes towards governmental actions (95%), self-hygiene (93.2%), social distancing (97.1%) and choice of healthy food (89.6%), and negative attitudes towards the current worldwide situation of the pandemic (81.0%) and hearing someone tested positive (77.8%) or died from COVID-19 (83.7%). High rates of compliance to behavior were reported by only 55.8% of participants in terms of precautionary measures (71.3%), preparedness (38.4%), and self-quarantine activities (46.1%). After adjusting for all possible confounders, the total attitude score was a significant predictor of the total scores of precautionary measures (t=12.01, p<0.001), preparedness (t=9.29, p<0.001), self-quarantine activities (t=12.05, p<0.001), and overall behavior response (t=14.09, p<0.001). Other significant predictors of higher overall behavior response scores were female gender (t=7.22, p<0.001) and non-Saudi nationality (t=3.40, p<0.001). This study provides baseline data on the behavioral response to the national COVID-19 pandemic in Saudi Arabia. The levels of compliance to behavior response and attitude to COVID-19 pandemic were less than satisfactory. Socio-demographics influence public behavior and protective health measures. COVID-19 awareness programs are recommended.

Background Medication errors (MEs) are among the most common types of medical errors and one of the most common and preventable causes of iatrogenic injuries. The aims of the present study were; (i) to determine the incidence and types of medication prescribing errors (MPEs), and (ii) to identify some potential risk factors in a pediatric inpatient tertiary care setting in Saudi Arabia. Findings A five-week retrospective cohort study identified medication errors in the general pediatric ward and pediatric intensive care unit (PICU) at King Abdulaziz Medical City (KAMC) through the physical inspection of physician medication orders and reviews of patients' files. Out of the 2,380 orders examined, the overall error rate was 56 per 100 medication orders (95% CI: 54.2%, 57.8%). Dose errors were the most prevalent (22.1%). These were followed by route errors (12.0%), errors in clarity (11.4%) and frequency errors (5.4%). Other types of errors were incompatibility (1.9%), incorrect drug selection (1.7%) and duplicate therapy (1%). The majority of orders (81.8%) had one or more abbreviations. Error rates were highest in prescriptions for electrolytes (17.17%), antibiotics (13.72%) and bronchodilators (12.97%). Medication prescription errors occurred more frequently in males (64.5%), infants (44.5%) and for medications with an intravenous route of administration (50.2%). Approximately one third of the errors occurred in the PICU (33.9%). Conclusions The incidence of MPEs was significantly high. Large-scale prospective studies are recommended to determine the extent and outcome of medication errors in pediatric hospitals in Saudi Arabia.

Patients allergic to antibiotics are at higher risk of receiving treatment with a broader spectrum, more harmful, and expensive agents. The aims of this study were (1) to assess the quality of documentation of antibiotics allergies in the electronic medical records (EMR) in a Pediatric tertiary care setting, and (2) to determine the validity of physicians' decision to hold antibiotics prescriptions. This is a retrospective cohort study at King Abdullah Specialized Children Hospital, Riyadh, Saudi Arabia. A review of the EMR and all Adverse Drug Reaction (ADR) reports of pediatric patients 1-14 years old, with a documented allergy to antibiotics from June 2016 until June 2019. The quality of documentation of antibiotics allergy was assessed based on the presence of four parameters: 1) allergy alert notification, 2) allergy severity classification, 3) setting notes, and 4) symptoms' description. In addition, all physicians' reports of allergy to antibiotics were cross-classified according to their corresponding ADR reports, and the validity of physicians' documentation of allergy was assessed. Of a total of 105 Pediatric patients' EMR, documentation of antibiotics allergy was available in 98 (93.3%), with the presence of symptoms description (83%), allergy notes (87%), severity (67%), and signs of alert (50.8%). Overall documentation quality was good for only 23.5% of patients, while it was poor for 35.7%. Physicians' documentation of antibiotics allergy was 0.82 sensitive [with 0.18 risk of allergy] and 0.60 specific [with 0.40 unnecessary restrictions of prescriptions]. Of all children with possible/actual allergies, only 38.9% were referred to the immunology clinic. The quality of documentation of antibiotic allergy in children and the validity of physicians' decisions are less than satisfactory. Therefore, improving communications between all healthcare providers regarding patients' allergy status and follow-up for further assessment of the reaction is recommended to improve patient care.

Background It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. Methods The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. Discussion This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. Trial registration ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843 . Registered on 27 July 2016.

Background Although patients frequently use patient information leaflets (PILs) to obtain information about medicine, their confidence in using it may be diminished after reading it. This study aimed to assess the public perception of PIL's quality and the perceived impact of its use on medication adherence. Methods A community-based cross-sectional study of 1,138 adult individuals in Saudi Arabia, April–May 2020, was conducted via Survey Monkey using an anonymous validated e-questionnaire. Data were collected on personal characteristics, PIL readership and preferences, perception towards PIL quality and impact of its use on taking medication, and reasons for not reading PIL. In addition, logistic regression analysis was performed to identify the significant predictors of reading PIL. Significance was considered at p  < 0.05. Results Nearly all participants (91.1%) reported reading PIL. The more read PIL's sections were directions of use (52.7%) and side effects (30.3%). Female gender (OR = 5.64, 95%CI: 3.53,9.02), age over 40 years (OR = 2.80, 95%CI: 1.69,4.64), and secondary education or more (OR = 1.74, 95%CI: 1.06,2.85) were the significant predictors of reading PIL. The majority of PIL readers reported their preference for verbal information (65.8%), hard copy presentation (77%), adding graphics (71.1%), and concise content of PIL (68.8%). In addition, most participants reported PIL always/usually adds to their knowledge of medicines (70.6%) and said that PIL reading positively impacted their medication adherence (64.9%). For only 8.8%, PIL reading negatively impacted their adherence, primarily because of reading information on medicine's side effects and complications (74.4%). More than one-half of participants perceived the PIL quality as good/excellent in terms of; font size (51.3%), language comprehensiveness (64.9%), paper quality (68.0%), and general appearance (64.9%). Getting sufficient information from doctors and pharmacists was the main reason for not reading the PIL (59.2%). Most participants (92.5%) agreed on standardizing how information is displayed in the PIL among all PILs of all companies. Conclusion PIL is read by nearly all the study sample, especially females, older, and educated subjects. It was perceived as beneficial in upgrading medication adherence. Effective designing of PILs should focus on patients' literacy level and age. Standardization of the PIL structure in all pharmaceutical companies is recommended.

Background Thiamine is a precursor of the essential coenzyme thiamine pyrophosphate required for glucose metabolism; it improves the immune system function and has shown to reduce the risk of several diseases. The role of thiamine in critically ill septic patient has been addressed in multiple studies; however, it’s role in COVID-19 patients is still unclear. The aim of this study was to evaluate the use of thiamine as an adjunctive therapy on mortality in COVID-19 critically ill patients. Methods This is a two-center, non-interventional, retrospective cohort study for critically ill patients admitted to intensive care units (ICUs) with a confirmed diagnosis of COVID19. All patients aged 18 years or older admitted to ICUs between March 1, 2020, and December 31, 2020, with positive PCR COVID-19 were eligible for inclusion. We investigated thiamine use as an adjunctive therapy on the clinical outcomes in critically ill COVID-19 patients after propensity score matching. Results A total of 738 critically ill patients with COVID-19 who had been admitted to ICUs were included in the study. Among 166 patients matched using the propensity score method, 83 had received thiamine as adjunctive therapy. There was significant association between thiamine use with in-hospital mortality (OR = 0.39; 95% CI 0.19–0.78; P value = 0.008) as well as the 30-day mortality (OR = 0.37; 95% CI 0.18–0.78; P value = 0.009). Moreover, patients who received thiamine as an adjunctive therapy were less likely to have thrombosis during ICU stay [OR (95% CI) 0.19 (0.04–0.88), P value = 0.03]. Conclusion Thiamine use as adjunctive therapy may have potential survival benefits in critically ill patients with COVID-19. Additionally, it was associated with a lower incidence of thrombosis. Further interventional studies are required to confirm these findings.

Background Type I interferons (IFNs) are essential antiviral cytokines induced upon respiratory exposure to coronaviruses. Defects in type I IFN signaling can result in severe disease upon exposure to respiratory viral infection and are associated with worse clinical outcomes. Neutralizing autoantibodies (auto‐Abs) to type I IFNs were reported as a risk factor for life‐threatening COVID‐19, but their presence has not been evaluated in patients with severe Middle East respiratory syndrome (MERS). Methods We evaluated the prevalence of type I IFN auto‐Abs in a cohort of hospitalized patients with MERS who were enrolled in a placebo‐controlled clinical trial for treatment with IFN‐β1b and lopinavir‐ritonavir (MIRACLE trial). Samples were tested for type I IFN auto‐Abs using a multiplex particle‐based assay. Results Among the 62 enrolled patients, 15 (24.2%) were positive for immunoglobulin G auto‐Abs for at least one subtype of type I IFNs. Auto‐Abs positive patients were not different from auto‐Abs negative patients in age, sex, or comorbidities. However, the majority (93.3%) of patients who were auto‐Abs positive were critically ill and admitted to the ICU at the time of enrollment compared to 66% in the auto‐Abs negative patients. The effect of treatment with IFN‐β1b and lopinavir‐ritonavir did not significantly differ between the two groups. Conclusion This study demonstrates the presence of type I IFN auto‐Abs in hospitalized patients with MERS.

Background and Purpose. Gentamicin (GEN) is a broad-spectrum antibiotic that cannot be prescribed freely because of its toxicity. Thymoquinone (THQ), a phytochemical, has antibacterial, antioxidant, and toxicity-reducing properties. However, its hydrophobicity and light sensitivity make it challenging to utilize. This incited the idea of co-encapsulating GEN and THQ in liposomes (Lipo-GEN-THQ). Method. Lipo-GEN-THQ were characterized using the zeta-potential, dynamic light scattering, Fourier transform infrared spectroscopy, and transmission electron microscope (TEM). The liposomes’ stability was evaluated under different storage and biological conditions. Lipo-GEN-THQ’s efficacy was investigated by the minimum inhibitory/bactericidal concentrations (MICs-MBCs), time–kill curves, and antibiofilm and antiadhesion assays. Bacterial interactions with the empty and GEN-THQ-loaded liposomes were evaluated using TEM. Results. The Lipo-GEN-THQ were spherical, monodispersed, and negatively charged. The Lipo-GEN-THQ were relatively stable and released GEN sustainably over 24 h. The liposomes exhibited significantly higher antibacterial activity than free GEN, as evidenced by the four-fold lower MIC and biofilm eradication in resistant E. coli strain (EC-219). TEM images display how the empty liposomes fused closely to the tested bacteria and how the loaded liposomes caused ultrastructure damage and intracellular component release. An antiadhesion assay showed that the Lipo-GEN-THQ and free GEN (0.125 mg/L) similarly inhibited Escherichia coli (EC-157) adhesion to the A549 cells (68% vs. 64%). Conclusions. The Lipo-THQ-GEN enhanced GEN by combining it with THQ within the liposomes, reducing the effective dose. The reduction in the GEN dose after adding THQ may indirectly reduce the toxicity and aid in developing an enhanced and safer form of GEN.