Saudi Cultural Missions Theses & Dissertations
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Item Restricted Real-World Data Synergy: Optimizing Clinical Trials Through Evidence Integration(King's College London, 2024-08-13) Alharrah, Abdullah; Prapopoulou, MariaBackground Integration of real-world evidence into clinical trials is an emerging approach, which attempts to increase the generalizability, credibility, and efficiency of clinical research. RWE, derived from sources such as EHRs, patient registries, and insurance claims, will provide real-world effectiveness and safety information for medical interventions. While it has a lot of potential, the best way to incorporate RWE into clinical studies remains relatively unexplored, and challenges associated with data quality, standardization, and adherence to the regulation are significant. Methods A systematic review was used to examine the current literature on the integration of Real-world evidence (RWE) in clinical trials and a stakeholder review to identify the methods, opportunities and challenges for this integration. The literature review aimed to examine studies from the past 10 years, focusing in the practical benefits in using RWE to enhance patient recruitment and site selection and evaluated the methods of integration and their challenges. Case studies from pharmaceutical industry and research institutions were analyzed to showcase the real-world applications of RWE. Results The research further identified key challenges in integrating RWE into clinical trials, such as data quality, data standardiza)on, and regulatory acceptance. It also brought out practical benefits that are related to RWE, among them improved patient recruitment, better efficiency in conducting trials, and facilitating validation and complementation of RCT findings. Case studies illustrated successful applications of RWE in several therapeutic areas, specifically on how this could be used in the design and conduct of clinical trials to enhance generalizability and applicability. Stakeholder survey highlighted the need for collaboration between stakeholders. Conclusion Real-world evidence showed positive outcome regarding patient safety and reduction of clinical trials duration and costs. Although RWE proved beneficial, challenges such as data quality, standardization, and regulatory compliance need to be addressed. Suggesting modification to current methodologies and regulatory guidance for improved patient outcomes and more informed healthcare decisions.4 0Item Restricted A radiographic analysis of short-term outcomes of second molars in proximity to wisdom teeth in periodontal patients (A retrospective radiographic study)(Queen Mary University of London, 2024) Alfurhud, Ahmed Ata O; Nikolaos, Gkranias; Edmund, Bailey; Nikolaos, DonosObjective: To evaluate radiographic changes in the alveolar bone on the distal surface of the second molars (2Ms) in the continued presence of impacted or semi-impacted third molars (ITMs) and following short term period with or without intervention. Materials and Methods: This was an observational study to assess the radiographic changes in the alveolar bone between two time points (T0) and (T1). Available x-rays were used and three measurements were taken on the distal surface of the 2Ms: (i) a vertical distance from the cementoenamel junction (CEJ) to the deepest apical bone extension of the intra-bony defect (BD); (ii) an oblique straight distance from BD to the most coronal position of the alveolar bone crest of the intra-bony defect (CB); and (iii) the angle formed from the vertical line from the identified CEJ to BD with an oblique line from BD to CB. The EMAGO 6.1 software was used to analyse the x-rays. The data was transferred to SPSS version 29.0, operating on the Mac OS platform. The database was secured upon completion. Descriptive statistics were then computed to provide an initial overview of the data. Statistical significance in the analysis was established with a threshold of p-value < 0.05 to ascertain significant differences between measurements obtained at different time points. Results: The retrospective analysis identified a total of 125 patients (9.6%) suitable for analysis out of 1302 patients (100%) through patient records as having either impacted or semi-impacted 3Ms. The mean age was 45 years with a standard deviation (SD) of 13 years. Out of the 125 patients, 218-second molars were analysed at T0 and only 68-second molars at T1 with a time interval of approximately 20 months, with a std. error of mean (SEM) estimated to be 62 days. In the initial findings, it was observed that ITMs in the mandible were higher compared to their upper counterparts, accounting for 73.7% of the cases at T0 and 81% at T1. Maxillary impaction was observed in only 26.7% of cases at T0 and 19% at T1. The most frequent angle of impaction was mesioangular, followed by vertical, distoangular, horizontal, and inverted impactions. Regarding the main results, no significant differences were found in vertical and oblique bone changes or angular bone changes between certain landmarks between T0 and T1. Gender significantly influenced the distribution of the linear measurement CEJ to BD (p= 0.022) not however, of the measurement between the BD and CB. The distribution of intrabony defect angle according to gender was statistically significant at T0 but not at adjusted T1, with p-values of 0.048 and 0.292, respectively. Analysing according to medical history, medication, ethnicity, smoking status, and ITM angulation did not show significant effects on any radiographic measurements or time points. However, patient age did seem to correlate with intrabony defect angles that almost reached significance with a p-value of 0.047. Conclusion: This specific analysis with the limitations presented did not seem to indicate that universal prophylactic ITM extraction would offer significant bone sparing benefit, nor does it show that prolonged ITMs presence will always have a continuous bone damaging effect on nearby 2Ms in the short-term. It suggests further research is needed to quantify the medium to long term risk and confirm or reject the hypothesis whether extraction of ITM can truly improve bone levels at 2Ms.12 0Item Restricted Transrectal Ultrasound guided biopsies of prostate for the detection of prostate cancer: outcomes and complications(Saudi Digital Library, 2023-08-23) Ghafra, Ebtehag; Ghulam, NabiObjective: To report clinical outcomes and complications of prostate biopsies guided by transrectal ultrasound for cancer detection. In addition to reporting the predictive value of clinical features for a negative biopsy for patients with elevated (PSA) levels across various age cohorts. Methods: This was a prospective study. Between 1st of January and 30th of June 2021, 200 individuals had transrectal ultrasound-guided or transperineal prostate biopsies. Patient characteristics (age, PSA level) were recorded through medical records. We also determined whether biopsy samples were cancerous or benign, their complications, and treatments. 186 patients with complete data were included. 14 patients with incomplete data were excluded. In addition, reported the predictive value by using a nomogram for a negative biopsy for patients with elevated (PSA) levels across various age cohorts. Results: 186 transrectal ultrasound-guided and transperineal (TP)biopsies were performed. There were 116 positive biopsy (cancers) (80.55%) in transrectal group and 35 (83.33%) in transperineal group. There were 28 negative biopsy (benign) (19.4%) in transrectal group and 7(16.66%) in transperineal group. Age differences between the groups were not statistically significant. PSA testing showed a significant difference (p value 0.01). There 9 cases where complications were recorded. There were 8 (5.55%) cases where complications were recorded in transrectal group and 9 (21.42%) in transperineal group. The prediction by a nomogram and assessment studies also reveals that predicting a benign biopsy is difficult when PSA levels reach 4 across all the age groups. Conclusion: The present study concluded that the results of prostate biopsies (PB) showed good detection rate for cancers. The results revealed that the number of biopsy complications is generally low and that TRUS may be safer than TP. In addition, the findings from the prediction by a nomogram and assessment analyses suggest that nomogram accurately predicted benign results when PSA was less than 4.13 0