Background: The Saudi Food and Drug Authority (SFDA) plays a pivotal role in safeguarding public health through robust pharmacovigilance. Since establishing its signal detection in 2015, SFDA has implemented a comprehensive framework to monitor and evaluate drug safety through proactive data collection, advanced analytical methods, and international collaborations. Objective: To provide a comprehensive analysis of the current practices in signal detection at SFDA, assess the effectiveness of its regulatory framework, in-house priority system, active surveillance programme, and global collaborations, and to offer recommendations for future enhancements in pharmacovigilance. Methods: A scientific review was conducted using publicly available literature, official SFDA guidelines, and internal reports. The evaluation focused on the regulatory mandate, data collection methodologies, signal generation processes (including weekly scanning of diverse sources), case validation, and the integration of advanced statistical techniques. Special emphasis was given to the in-house priority algorithm, active surveillance initiatives, and collaborative efforts with international bodies. Results: The review highlights that SFDA's robust regulatory framework and innovative in-house priority algorithm have enhanced the efficiency of signal detection. The active surveillance programme has significantly increased the capacity for real-time monitoring, while global collaborations have facilitated knowledge exchange and harmonised methodologies. However, challenges persist regarding data quality, resource allocation, and the need for continuous training and improved communication among stakeholders. Conclusion: SFDA's signal detection system effectively contributes to drug safety in Saudi Arabia by combining rigorous regulatory practices with innovative analytical methods and international cooperation. Addressing current challenges through advanced technologies, enhanced resource allocation, and strengthened stakeholder communication is recommended to further improve pharmacovigilance practices and ensure public health protection.

Background: Despite increasing interest in quality end-of-life care (EOLC), critically ill patients often receive suboptimal care. Critical care nurses play a crucial role in EOLC, but face numerous barriers that hinder their ability to provide compassionate and effective care. Methods: An integrative literature review was conducted to investigate barriers impacting the quality of end-of-life care. This review process involved searching database like MEDLINE, Cochrane Central Register of Controlled Trials, CINAHL, EBSCO, and ScienceDirect up to November 2023. Search strategies focused on keywords related to barriers in end-of-life care and critical care nurses from October 30th to November 10th, 2023. The inclusion criteria specified full-text English articles published between 2010 and 2023 that addressed barriers perceived by critical care nurses. This integrative review employs an integrated thematic analysis approach, which combines elements of deductive and inductive analysis, to explore the identified barriers, with coding and theme development overseen by the primary and secondary authors. Results: Out of 103 articles published, 11 articles were included in the review. There were eight cross-sectional descriptive studies and three qualitative studies, which demonstrated barriers affecting end-of-life care quality. Quality appraisal using the Mixed Method Appraisal Tool was completed by two authors confirmed the high credibility of the selected studies, indicating the presence of high-quality evidence across the reviewed articles. Thematic analysis led to the three main themes (1) barriers related to patients and their families, (2) barriers related to nurses and their demographic characteristics, and (3) barriers related to health care environment and institutions. Conclusion: This review highlights barriers influencing the quality of end of life care perceived by critical care nurses and the gaps that need attention to improve the quality of care provided for patients in their final stages and their fsmilies within the context of critical care. This review also notes the need for additional research to investigate the uncover patterns and insights that have not been fully explored in the existing literature to enhance understanding of these barriers. This can help to inform future research, care provision, and policy-making. Specifically, this review examines how these barriers interact, their cumulative impact on care quality, and potential strategies to overcome.

Background: HVPG measurement is the gold standard for assessing portal hypertension. Many patients decline HVPG measurements due to associated pain. According to previous studies, propofol sedation during HVPG measurements potentially alters HVPG readings. However, opioid analgesics' effects on HVPG await full elucidation. This study aimed to evaluate fentanyl analgesia's effects on HVPG measurement accuracy in patients with cirrhosis. Methods: This prospective, multicenter study included patients with cirrhosis undergoing HVPG measurements, which were performed preanalgesia and under analgesia with fentanyl injection (1.0 or 1.5 μg/kg). Results: Of the 48 enrolled patients with cirrhosis, 23 were administered 1.0 μg/kg fentanyl analgesia during HVPG measurement. The HVPG was 13.4±4.9 mm Hg in preanalgesia and 13.5±5.2 mm Hg under analgesia. HVPG measurement accuracy was not altered after fentanyl analgesia (p = 0.801). The following measures also did not change: heart rate (p = 0.132), mean arterial pressure (p = 0.348), and blood oxygen saturation (p = 0.748); however, respiratory rate (p = 0.001) changes occurred. The Verbal Numerical Rating Score for comfort under analgesia was higher than that in preanalgesia (p = 0.001). Twenty-five patients were administered 1.5 μg/kg fentanyl analgesia during HVPG measurement. The HVPG was 19.5±5.7 mm Hg in preanalgesia and 19.6±5.6 mm Hg under analgesia. HVPG measurement accuracy did not alter after fentanyl analgesia (p = 0.469). Similarly, the following measures did not change: mean arterial pressure (p = 0.871) and oxygen saturation (p = 0.327); nevertheless, respiratory rate (p = 0.015) and heart rate (p = 0.019) changes occurred. The Verbal Numerical Rating Score for comfort under analgesia was higher than that in preanalgesia (p < 0.001). Conclusion: Fentanyl analgesia did not alter HVPG measurement accuracy, and fentanyl improved comfort in patients with cirrhosis during HVPG measurements.

Background: COVID-19 might be a risk factor for various chronic diseases. However, the association between COVID-19 and the risk of incident diabetes remains unclear. We aimed to meta-analyze evidence on the relative risk of incident diabetes in patients with COVID-19. Methods: In this systematic review and meta-analysis, the Embase, PubMed, CENTRAL, and Web of Science databases were searched from December 2019 to June 8, 2022. We included cohort studies that provided data on the number, proportion, or relative risk of diabetes after confirming the COVID-19 diagnosis. Two reviewers independently screened studies for eligibility, extracted data, and assessed risk of bias. We used a random-effects meta-analysis to pool the relative risk with corresponding 95 % confidence intervals. Prespecified subgroup and meta-regression analyses were conducted to explore the potential influencing factors. We converted the relative risk to the absolute risk difference to present the evidence. This study was registered in advance (PROSPERO CRD42022337841). Main findings: Ten articles involving 11 retrospective cohorts with a total of 47.1 million participants proved eligible. We found a 64 % greater risk (RR = 1.64, 95%CI: 1.51 to 1.79) of diabetes in patients with COVID-19 compared with non-COVID-19 controls, which could increase the number of diabetes events by 701 (558 more to 865 more) per 10,000 persons. We detected significant subgroup effects for type of diabetes and sex. Type 2 diabetes has a higher relative risk than type 1. Moreover, men may be at a higher risk of overall diabetes than women. Sensitivity analysis confirmed the robustness of the results. No evidence was found for publication bias. Conclusions: COVID-19 is strongly associated with the risk of incident diabetes, including both type 1 and type 2 diabetes. We should be aware of the risk of developing diabetes after COVID-19 and prepare for the associated health problems, given the large and growing number of people infected with COVID-19. However, the body of evidence still needs to be strengthened.

PURPOSE: Integrating equity, diversity, and inclusivity (EDI) in curricula for training health professionals is a frequent institutional goal. The use of standardized (or simulated) patient programs (SPPs) to support EDI in health sciences training is not well described. Here the authors present a theoretical model based on a synthesis of the literature for using SPPs in EDI training, along with a narrative review of the available literature. METHOD: The authors searched PubMed, Scopus, Science Direct, and Google Scholar databases for studies published between January 2000 and October 2019 describing the use of SPPs to support EDI in health sciences education. Studies were included if they described standardized patient (SP) education involving EDI and reported empiric data about its design, delivery, or effectiveness. The authors conducted a narrative review and provide a synthesis of the available literature, identifying key themes. RESULTS: Out of 117 studies identified, 17 met the inclusion criteria. Most studies (53%; n = 9) focused on cultural competence; many focused on communication with diverse patients (29%; n = 5) or health inequity (18%; n = 3). Studies employed portrayal of diversity (71%; n = 12) or learning objectives supported by diversity (29%; n = 5) as approaches to EDI relevant to SP training. Three primary themes emerged: improving cultural competence, effective communication with diverse patients, and highlighting health inequalities. CONCLUSIONS: This review outlines approaches to EDI-based SPPs, with the perspectives and priorities of institutional approaches in mind. SP education around specific EDI issues is reported; however, programmatic approaches to EDI by SPPs are lacking. More research is needed to provide further evidence for the challenges, effectiveness, and outcomes of developing and implementing EDI-based SPPs in health sciences education.

Background:Pharmacotherapy provides an option for adults with overweight and obesity to reduce their bodyweight if lifestyle modifications fail. We summarised the latest evidence for the benefits and harms of weight-lowering drugs. Methods:This systematic review and network meta-analysis included searches of PubMed, Embase, and Cochrane Library (CENTRAL) from inception to March 23, 2021, for randomised controlled trials of weight-lowering drugs in adults with overweight and obesity. We performed frequentist random-effect network meta-analyses to summarise the evidence and applied the Grading of Recommendations Assessment, Development, and Evaluation frameworks to rate the certainty of evidence, calculate the absolute effects, categorise interventions, and present the findings. The study was registered with PROSPERO, CRD 42021245678. Findings:14 605 citations were identified by our search, of which 132 eligible trials enrolled 48 209 participants. All drugs lowered bodyweight compared with lifestyle modification alone; all subsequent numbers refer to comparisons with lifestyle modification. High to moderate certainty evidence established phentermine-topiramate as the most effective in lowering weight (odds ratio [OR] of ≥5% weight reduction 8·02, 95% CI 5·24 to 12·27; mean difference [MD] of percentage bodyweight change -7·98, 95% CI -9·27 to -6·69) followed by GLP-1 receptor agonists (OR 6·33, 95% CI 5·00 to 8·00; MD -5·79, 95% CI -6·34 to -5·25). Naltrexone-bupropion (OR 2·69, 95% CI 2·10 to 3·44), phentermine-topiramate (2·40, 1·68 to 3·44), GLP-1 receptor agonists (2·22, 1·74 to 2·84), and orlistat (1·71, 1·42 to 2·05) were associated with increased adverse events leading to drug discontinuation. In a post-hoc analysis, semaglutide, a GLP-1 receptor agonist, showed substantially larger benefits than other drugs with a similar risk of adverse events as other drugs for both likelihood of weight loss of 5% or more (OR 9·82, 95% CI 7·09 to 13·61) and percentage bodyweight change (MD -11·40, 95% CI -12·51 to -10·29). Interpretation:In adults with overweight and obesity, phentermine-topiramate and GLP-1 receptor agonists proved the best drugs in reducing weight; of the GLP-1 agonists, semaglutide might be the most effective.

Junior doctors’ exposure to bullying may impact their training and compromise quality healthcare, yet little is known in relation to its predictors and effects. The aim of this paper is to assess the prevalence, factors and outcomes of workplace bullying among junior doctors. Literature search was performed to identify all primary studies examining workplace bullying among junior doctors using the following electronic databases: Medline, Scopus, Web of Science, PsycINFO and Cochrane Library. A total of 18 articles were included, reporting on a total of 9,597 junior doctors. The quality of evidence can be rated as moderate according to the Newcastle Ottawa Scale. From the review, a wide range (30–95%) of bullying prevalence, significant differences in bullying rates according to gender, age, height, ethnicity and subspecialty, and significant associations between bullying and mental strain, job dissatisfaction, burnout, and increased accidents at work were observed. Concurrently, heterogeneity in the terms and methodologies used to examine workplace bullying as well as definitional issues in relation to the persistency of negative interactions were noted. Evidence suggests that workplace bullying is a serious occupational hazard for junior doctors, and more research is warranted to better understand this phenomenon and address its definitional and methodological issues.

To evaluate the association between shift work and risk of type 2 diabetes mellitus, we searched PubMed, EMBASE and Web of Science from their inception to June 8, 2019. Observational studies examining the relationship between shift work and type 2 diabetes were included. Subgroup analyses were conducted to explore whether specific characteristics would affect the relationship. A dose-response relationship was estimated by using generalized least squares trend regression. Finally, twelve cohort studies and nine cross-sectional studies were included (inter-rater agreement, k = 0.96). The result of meta-analysis indicated that shift work was associated with an increased risk of type 2 diabetes (relative risk = 1.10, 95% confidence interval = 1.05-1.14). Subgroup analyses demonstrated that female shift workers have increased risk of type 2 diabetes while male not observed, health care workers showed the highest risk compared with civil servants and manual workers, and night shift and rotating shift were associated with an increased risk of type 2 diabetes. Dose-response meta-analysis based on three cohorts among female workers indicated that there might be a positive association between duration of shift work and the risk of type 2 diabetes. In conclusion, shift work is positively associated with an increased risk of type 2 diabetes. Among female workers, with the years of exposure to shift work prolonged, the risk of type 2 diabetes might increase accordingly. In the future, more studies are needed to confirm the results of dose-response analysis.

PURPOSE: To evaluate the association between cigarette smoking and lumbar disc herniation (LDH). METHODS: Cohort or case-control studies were identified by searches of several data bases, including Pubmed, Embase, Web of Science, and BIOSIS, for entries made up to December 2014. Data extraction was performed by two independent investigators. The data synthesis was performed using the random effects model. Subgroup analysis, sensitivity analyses, and assessment for publication bias were also performed. RESULTS: This systematic review included 12 studies-six each of cohort and case-control studies. The combined reported values showed that the relative risk of the association between smoking and LDH was 1.27 [95 % confidence interval (CI), 1.15-1.40] overall, 1.48 (95 % CI, 1.27-1.73) for case-control studies, and 1.17 (95 % CI, 1.05-1.30) for cohort studies. CONCLUSION: This systematic review demonstrates that smoking promotes the development of LDH

OBJECTIVE: To evaluate the utilization of mobile phone technology for treatment adherence, prevention, education, data collection, monitoring long-term management of HIV/AIDS and TB patients. METHODS: Articles published in English language from January 2005 until now from PubMed/MEDLINE, EMBASE, Web of Science, WHO databases, and clinical trials were included. Data extraction is based on medication adherence, quality of care, prevention, education, motivation for HIV test, data collection from HIV lab test results and patient monitoring. Articles selected for the analysis cover RCTs and non RCTs related to the use of mobile phones for long-term care and treatment of HIV/AIDS and TB patients. RESULTS: Out of 90 articles selected for the analysis, a large number of studies, 44 (49%) were conducted in developing countries, 24 (26%) studies from developed countries, 12 (13%) are systematic reviews and 10 (11%) did not mention study location. Forty seven (52.2%) articles focused on treatment, 11 (12.2%) on quality of care, 8 (9%) on prevention, 13 (14.4%) on education, 6 (6.6%) on data collection, and 5 (5.5%) on patient monitoring. Overall, 66 (73%) articles reported positive effects, 21 (23%) were neutral and 3 (4%) reported negative results. CONCLUSIONS: Mobile phone technology is widely reported to be an effective tool for HIV/AIDS and TB long-term care. It can substantially reduce disease burden on health care systems by rendering more efficient prevention, treatment, education, data collection and management support

Hematopoietic stem cell transplantation (HSCT) and consolidation chemotherapy have been used to treat intermediate-risk acute myeloid leukemia (AML) patients in first complete remission (CR1). However, it is still unclear which treatments are most effective for these patients. The aim of our study was to analyze the relapse-free survival (RFS) and overall survival (OS) benefit of allogeneic HSCT (alloHSCT) for intermediate-risk AML patients in CR1. A meta-analysis of prospective trials comparing alloHSCT to non-alloHSCT (autologous HSCT [autoHSCT] and/or chemotherapy) was undertaken. We systematically searched PubMed, Embase, and the Cochrane Library though October 2014, using keywords and relative MeSH or Emtree terms, 'allogeneic'; 'acut*' and 'leukem*/aml/leukaem*/leucem*/leucaem*'; and 'nonlympho*' or 'myelo*'. A total of 7053 articles were accessed. The primary outcomes were RFS and OS, while the secondary outcomes were treatment-related mortality (TRM) and relapse rate (RR). Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for each outcome. The primary outcomes were RFS and OS, while the secondary outcomes were TRM and RR. We included 9 prospective controlled studies including 1950 adult patients. Patients with intermediate-risk AML in CR1 who received either alloHSCT or non-alloHSCT were considered eligible. AlloHSCT was found to be associated with significantly better RFS, OS, and RR than non-alloHSCT (HR, 0.684 [95% CI: 0.48, 0.95]; HR, 0.76 [95% CI: 0.61, 0.95]; and HR, 0.58 [95% CI: 0.45, 0.75], respectively). TRM was significantly higher following alloHSCT than non-alloHSCT (HR, 3.09 [95% CI: 1.38, 6.92]). However, subgroup analysis showed no OS benefit for alloHSCT over autoHSCT (HR, 0.99 [95% CI: 0.70, 1.39]). In conclusion, alloHSCT is associated with more favorable RFS, OS, and RR benefits (but not TRM outcomes) than non-alloHSCT generally, but does not have an OS advantage over autoHSCT specifically, in patients with intermediate-risk AML in CR1

The effect of neoadjuvant chemotherapy on the survival of patients with thoracic esophageal squamous cell carcinomas (ESCCs) remains controversial. The optimal management strategy for resectable ESCCs varies regionally based on local randomized controlled trials. A systematic review and meta-analysis was conducted to re-evaluate this controversial issue.A systematic review of the Medline, Embase, and PubMed databases was carried out on data collected between August 1994 and August 2014 to evaluate the role of neoadjuvant chemotherapy. Only randomized controlled trials comparing the effects of neoadjuvant chemotherapy with that of surgery and surgery plus adjuvant chemotherapy were selected.Six studies with a total of 1202 patients were identified, consisting of a neoadjuvant chemotherapy arm (n = 597) and a surgery alone and surgery plus adjuvant chemotherapy arm (n = 605). The 5-year overall survival benefit for neoadjuvant chemotherapy was statistically significant at alpha = 0.1 (hazard ratio = 0.81, 95% confidence intervals, 0.65-1.00, P = 0.053). All 6 trials recruited patients for more than 5 years with undefined lymphadenectomies. Cisplatin and fluorouracil were adopted as neoadjuvant chemotherapy regimens.The role of neoadjuvant chemotherapy for ESCC is worth re-investigating. The design of randomized controlled trials should adopt new chemotherapy regimens as well as define the surgical procedure and the details of the lymphadenectomy

Gastrointestinal (GI) disorders often manifest similar symptoms with overlapping clinical diagnosis and unmet medical needs. Traditional Chinese medicine (TCM) has history-proven benefits for GI diseases; albeit language barrier prevents Western readers from accessing the original reports in Chinese. The TCM formula Si-Ni-San (SNS) consists of 4 herbs targeting on homeostatic disturbances characterized by 'reflux' and 'irritable' problems. Here we used SNS as a therapeutic tool to explore the common mechanisms of pathogenesis in non-neoplastic GI diseases.Data sources from PUBMED, Chinese National Knowledge Infrastructure, and Wanfang databases were searched for clinical trials. Comparisons were SNS as intervention and Western conventional medicine as control, which treat patients with upper GI disorders (gastroesophageal reflux disease, peptic ulcer, chronic gastritis, duodenogastric reflux), lower GI diseases (irritable bowel syndrome, ulcerative colitis), and functional dyspepsia. Participants and studies in accordance with the Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement were eligible. We used the Jadad scale to assess methodological qualities, the fixed or random-effect model to evaluate therapeutic efficacy, and the funnel plots to explore publication bias. Outcome was clinical efficacy defined by symptom relief with normal GI endoscopy, radiology, and pathology.We included 83 studies involving 7762 participants: 1708 versus 1397 of the upper GI disorders in 34 studies, 901 versus 768 of the lower GI diseases in 19 studies, 1641 versus 1348 of functional dyspepsia in 30 studies, and 328 versus 287 of relapse rate in 8 studies. Six studies had a Jadad score >2 points and the rest were <2 points. Pooled data showed significant efficacy of SNS for the upper GI disorders (odds ratio [OR] = 3.9, 95% confidence interval [CI] = 3.09-4.92), lower GI diseases (OR = 4.91, 95% CI = 3.71-6.51), and functional dyspepsia (N = 2989; OR = 3.94, 95% CI = 3.17-4.90). The relapse rate was 12.9% for SNS, significantly <46.5% for conventional therapies (OR = 0.16, 95% CI = 0.11-0.25).The consistent efficacy of the single TCM formula implicates common mechanisms of pathogenesis in GI disorders

Background Training of lay refugees/internally displaced persons (IDPs) and deploying them to provide basic health services to other women, children, and families in camps is perceived to be associated with public health benefits. However, there is limited evidence to support this hypothesis. Objectives To assess the effects of interventions to train and deploy lay refugees and/or IDPs for the provision of basic health service to other women, children, and families in camps. Methods PubMed, Science and Social Science Citation Indices, PsycINFO, EMBASE, POPLINE, CINAHL, and reference lists of relevant articles were searched (from inception to June 30, 2014) with the aim of identifying studies that reported the effects of interventions that trained and deployed lay refugees and/or IDPs for the provision of basic health service to other women, children, and families in camps. Two investigators independently reviewed all titles and abstracts to identify potentially relevant articles. Discrepancies were resolved by repeated review, discussion, and consensus. Study quality assessment was undertaken using standard protocols. Results Ten studies (five cross-sectional, four pre-post, and one post-test only) conducted in Africa (Guinea and Tanzania), Central America (Belize), and Asia (Myanmar) were included. The studies demonstrated some positive impact on population health associated with training and deployment of trained lay refugees/IDPs as health workers in camps. Reported effects included increased service coverage, increased knowledge about disease symptoms and prevention, increased adoption of improved treatment seeking and protective behaviors, increased uptake of services, and improved access to reproductive health information. One study, which assessed the effect of peer refugee health education on sexual and reproductive health, did not demonstrate a marked reduction in unintended pregnancies among refugee/IDP women. Conclusion Although available evidence suggests a positive impact of training and deployment of lay refugees/IDPs as health workers in camps, existing body of evidence is weak, and calls for a re-examination of current practices. Interventions that promote training and deployment of lay refugees/IDPs as health workers in camps should include strong evaluation components in order to facilitate assessment of effects on population health.