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Objectives: To quantify use of patient-reported outcomes (PROs) in interventional trials conducted in Saudi Arabia and to determine whether PRO usage varies according to key trial characteristics. Methods: The ClinicalTrials.gov database was searched to identify all interventional trials located in Saudi Arabia. Two authors screened each trials primary and secondary outcomes and categorized each trial into: (1) trials in which PROs were mentioned or (2) trials in which PROs were not mentioned. The Chi-square test was used to examine associations between PRO use and certain trial characteristics. Results: The search identified 933 trials. Forty percent (n=371) reported PROs as primary (n=141, 38%) or secondary (n=178, 48%) outcomes or both (n=52, 14%). The number of PRO instruments was 535. Pain was the most common PRO (n=164, 31%). Trials characteristics associated with more use of PROs included nonindustry-sponsored trials, trials focusing on nondrug interventions, phase 3 trials and trials conducted exclusively in Saudi Arabia. Conclusion: Forty percent of the registered clinical trials in Saudi Arabia used at least one PRO. This highlights the need to address barriers to PRO use to facilitate generation of local evidence. Keywords: Patient-reported outcomes measures, Clinical trials, Patient outcome assessment

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In view of a constant increase in the number of patients treated with antipsychotic medications, the problem of nonadherence to the prescribed treatment becomes particularly relevant. Since one of the major contributors to the nonadherence is the presence of side effects of the drugs being used, the availability of tools for assessment of adverse reactions is of great importance. The objective of the present work was to develop an Arabic language version of the Glasgow Antipsychotic Side-effect Scale (GASS). After confirming the accuracy of translation, the questionnaire was given to 100 patients in two psychiatric centers in Saudi Arabia. The Cronbach's alpha (0.793) indicated a good reliability of the survey. The mean GASS score was 19.09, indicating absent or mild side effects of antipsychotics, but 46% of patients experienced moderate, and 25% experienced severe side effects. An analysis of the correlation between patients' characteristics and side effects revealed the presence of a positive relationship between the side effects and health literacy. It is expected that the Arabic-GASS will benefit Arabic-speaking psychiatric patients by helping them to express their concerns about side effects of antipsychotics. The collected results also document the importance of patients' health literacy in achieving high-quality healthcare.

Background Down syndrome (DS), or Trisomy 21, is defined by the existence of an additional chromosome 21. Various physiological considerations in DS patients might lead to challenges in adequate pain management and sedation after surgery. The aim of this systematic review and meta-analysis is to evaluate the variations of the requirement needed for pain management and sedation in patients with DS who have undergone surgery compared to patients without DS. Methods A systematic review and meta-analysis of studies were conducted, focusing on critically ill patients with DS who were admitted to Intensive care units (ICUs) post-surgery and received opioids and/or benzodiazepines. Searches were conducted in four databases from their inception to November 18, 2023 (Pubmed, Scopus, Cochrane Library, and Web of Science). The primary outcome measured was the dosage of Oral Morphine Equivalent (OME) administered in the days following surgery. Fixed-effect models were used, an approach advisable when only a limited number of studies are available. Results Out of the 992 studies initially screened, the systematic review included ten studies, encompassing 730 patients, while the meta-analysis consisted of seven studies, encompassing 533 patients. Of the seven studies included in the analysis, 298 patients were identified to have DS, and 235 patients served as controls. Patients with DS showed a slight increase in OME needs on the first day, but this increase was not statistically significant (mean difference [MD] = 0.09; 95% Confidence Interval [CI]: [-0.02, 0.20]; P  = 0.11). There was also no significant difference in the requirement for Midazolam on the first day among DS patients (MD = 0.01; CI [-0.16, 0.19]; P  = 0.88). In addition, the duration of mechanical ventilation was not statistically significant in patients with DS compared with the control group (MD = -1.46 hours; 95% CI [-9.74, 6.82]; P  = 0.73). Conclusion Patients with Down syndrome did not require more sedation or analgesia in the first three days after surgery than patients without Down syndrome. Additionally, the two groups showed no significant difference in the duration of mechanical ventilation.

Background There is a growing recognition of the importance of teaching patient safety to medical students to improve healthcare and minimize patients’ harm; however, few studies evaluated the attitudes of pharmacy students toward patient safety. The purpose of this study was to explore the attitudes toward patient safety among pharmacy students in Saudi Arabia. Methods A cross-sectional study was conducted among pharmacy students from four different universities using a self-administered questionnaire. The Attitudes to Patient Safety Questionnaire III (APSQ-III) was used to measure the attitude toward patient safety. The data were presented using descriptive statistics, such as percentages and means, and compared across gender using Student’s t-test. Results All of the students who agreed to participate and signed the consent form have completed the questionnaire. Of the 347 pharmacy students who participated in the study; 63% were enrolled in the Doctor of Pharmacy Program and 37% were enrolled in the Bachelor of Pharmaceutical Sciences program. Only 46% of the participants received courses for patient safety mainly in the fourth year of their pharmacy program, and around 93% were interested to learn more about patient safety. A more positive attitude toward patient safety was reported in the domain of ‘confidence to report errors’, ‘working hours as error cause’, ‘patient involvement in reducing error’, and ‘team functioning’. However, most negative attitudes were reported in the domains of ‘Error inevitability’ and ‘Disclosure responsibility’. Gender differences were noticed in the attitude toward patient safety; female students had more positive attitudes in most domains of patient safety. Conclusions Around one-half of the surveyed pharmacy students did not receive any courses on patient safety. Our findings emphasize the need for including patient safety courses in the curricula of the different pharmacy programs given the patient safety training importance in improving the quality of patient care.

Background: Biosimilars are designed to closely resemble their reference biologics in terms of quality, safety, and efficacy, with only minor variations in clinically inactive components and manufacturing methods. Evaluating the safety of switching between these products is critical for healthcare providers and patients. Concerns may arise when transitioning patients from a reference biologic to a biosimilar or between different biosimilars. Objective: This systematic review and meta-analysis aims to evaluate the frequency of adverse events associated with switching from a reference biologic to its biosimilar, using data derived from randomized controlled trials (RCTs). Methods: A comprehensive search was conducted in MEDLINE and Cochrane Central databases from their inception to December 2024. Studies included RCTs that reported adverse reactions related to switching between reference-to-reference biologics and reference-to-biosimilar biologics. Record screening, data extraction, and risk of bias assessment were performed independently by two reviewers. Random effects models were applied to pool crude outcome data. Results: The search identified 668 abstracts, with an additional 14 studies found through hand-searching review articles. Of these, 12 trials involving 1326 participants in the reference–reference group and 1176 participants in the reference–biosimilar group met the inclusion criteria. The frequency of adverse events, serious adverse events, and treatment-related adverse events did not differ significantly between the reference–reference and reference–biosimilar groups: relative risk (RR) = 0.96 (95% confidence interval [CI], 0.85–1.08), RR = 1.06 (95% CI, 0.68–1.65), and RR = 1.03 (95% CI, 0.66–1.59), respectively. Heterogeneity was generally low to moderate across outcomes, and subgroup analyses based on disease type and reference product showed no differences. Conclusions: Switching between reference biologics and biosimilars demonstrates a comparable safety profile, suggesting that both options are viable. However, the findings are limited by the small number of trials and the scope of patient populations and products studied. PROSPERO registration number: CRD42021267205.

Objectives Bleeding remains a common complication post-thoracic surgery. Although intravenous tranexamic acid (TXA) has been shown to decrease blood loss, its use has been associated with adverse effects. Accordingly, topical TXA has been proposed as an alternative to reduce bleeding with fewer systemic complications. Methods We searched Medline, Embase, and Cochrane Central databases for randomized controlled trials (RCTs) comparing topical TXA versus control (i.e., placebo) in patients undergoing thoracic procedures. The primary outcome was total postoperative blood loss at 24 hours. Secondary outcomes included were the number of red blood cell (RBC) transfusions, and hospital length of stay (LOS). Meta-analyses were pooled using mean difference with inverse-variance weighting and random-effects. Results Out of the 575 unique studies that were screened, we identified three randomized controlled trials (RCTs) involving 399 patients. Out of the three RCTs analyzed, two studies, accounting for 67% of the total, were found to have a low risk of bias. The primary outcome of 24-h post-operative blood loss was significantly lower in patients who received TXA (mean difference [MD] −93.6 ml, 95% CI −121.8 to −65.4 ml, I2 = 45%). In addition, the need for RBC transfusion was significantly lower in the topical TXA group compared to control (MD −0.5 units, 95% CI −0.8 to −0.3 units, I2 = 60%). However, there was no significant difference in the hospital length of stay (LOS) (MD −0.3 days, 95% CI −0.9 to 0.4 days, I2 = 0%). These results remained consistent after several sensitivity analyses. The use of topical intrapleural tranexamic acid has also been found to be safe without any significant safety concerns. Conclusion Topical intrapleural TXA reduces blood loss and the need for blood transfusions during thoracic surgery. In addition, there is no evidence of the increased safety concerns associated with its use. Larger trials are necessary to validate these findings and evaluate the safety and efficacy of different dosages.

Investigating pharmacovigilance (PV) practices among oncology healthcare providers (HCPs) is crucial for patient safety in oncology settings. This study aimed to assess the awareness, attitudes, and practices towards PV and identify barriers to effective adverse drug reaction (ADR) reporting for HCPs working in oncology-related settings. Employing a cross-sectional survey design, we collected data from 65 HCPs, focusing on their experiences with ADR reporting, education on ADR management, and familiarity with PV protocols. The results showed that about half of the responders were pharmacists. Around 58.9% of the respondents reported ADRs internally, and 76.9% had received some form of ADR-related education. However, only 38.5% were aware of formal ADR review procedures. Methotrexate and paclitaxel emerged as the drugs most frequently associated with ADRs. The complexity of cancer treatments was among the common reasons for the low reporting of ADRs by the study participants. The findings highlight the need for enhanced PV education and standardized reporting mechanisms to improve oncology care. We conclude that reinforcing PV training and streamlining ADR-reporting processes are critical to optimizing patient outcomes and safety in oncology, advocating for targeted educational interventions and the development of unified PV guidelines.

Bariatric surgery provides an effective option for the management of morbid obesity. Several studies have investigated the association between bariatric surgery and secondary hyperparathyroidism (SHPT). This study aims to compare the levels of blood biomarkers, specifically, calcium (Ca), vitamin D, and phosphate (PO4), and their association with parathyroid hormone (PTH) levels pre- and post-bariatric surgery. In addition, it aims to assess the prevalence of hyperparathyroidism post-bariatric surgery in a tertiary care hospital in Saudi Arabia. A prospective cohort study was conducted at a large tertiary care hospital between May 2017 and April 2019. The study included adult obese patients who underwent laparoscopic sleeve gastrectomy (LSG). Patients were excluded if they were known to have any comorbidities, receiving vitamin supplements, and those who had undergone bariatric procedures previously. Routine blood tests, including PTH, vitamin D, Ca, and PO4, were collected at baseline, and post-surgery. A total of 143 patients who underwent LSG were included in the study. Hyperparathyroidism was observed in 15.4% of patients at baseline and in 36.4% of patients' post-surgery (p < 0.001). Low vitamin D levels, which were highly prevalent before surgery, decreased sustainably (66.4% pre-operative and 28% at follow-up after surgery, P=0.032). Baseline hypocalcemia was observed in 20.3% of patients compared to 8.4% post-surgery (P=0.546). Hypophosphatemia was present in 60.8% of subjects at baseline, while the percentage dropped to 21.7% post-surgery. There was a significant association between PO4 and PTH levels at baseline. Post-operatively, there was a significant correlation between PTH and both vitamin D and calcium levels. Our study showed that the higher levels of PTH post LSG can be related to vitamin D deficiency and lower calcium levels, despite patients following the provided recommendations for supplementation. This study also emphasizes the importance of routine testing for hyperparathyroidism both before and after bariatric surgery.

The prevalence of venous thromboembolism is high in patients with COVID-19, despite prophylactic anticoagulation. The evidence that supports the preferred thromboprophylaxis regimen in non-critically ill patients with mild to moderate COVID-19 is still limited. Therefore, this systematic review and meta-analysis aimed to compare the clinical outcomes of hospitalized patients with mild to moderate COVID-19 who received standard thromboprophylaxis anticoagulation with intermediate to high prophylaxis regimens. We systematically searched MEDLINE and Embase databases for published studies until August 17th, 2022. We included studies on patients with mild to moderate COVID-19 who received thromboprophylaxis during their hospital stay. Patients who received standard prophylaxis dose “control group” were compared to patients who received intermediate to high prophylaxis “intervention group”. Random effect models were used when pooling crude numbers and adjusted effect estimates of study outcomes. A comprehensive analysis was conducted, encompassing seven studies involving a total of 1931 patients. The risk of all-cause thrombosis was not statistically different between the two groups (risk ratio [RR] 1.48, 95% confidence interval [CI] [0.11, 20.21]). The risk of minor bleeding was reported to be lower in patients who received intermediate to high prophylaxis (RR 0.64, 95% CI 0.21, 1.97), while had a higher risk of major bleeding compared with the standard prophylaxis (RR 1.40, 95% CI 0.43, 4.61); however, did not reach the statistical significance. The overall risk for all hospital mortality favored the utilization of intermediate to high doses over the standard thromboprophylaxis dosing (RR 0.47, 95%CI 0.29, 0.75). In medically ill patients with COVID-19, there is no difference between standard and intermediate to high prophylaxis dosing regarding thrombosis and bleeding. However, it appears that intermediate to high prophylaxis regimens are linked to additional survival benefits.