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Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Background The ethics committee has the responsibility to comply with the rules and guidelines regarding oversight of all human research activities, particularly when the research study involves vulnerable people. It also has the role of educating researchers on ethical issues, scientific truthfulness, preventing misconduct and conflicts of interest. In our study we evaluate and benchmark the function of the local ethical committees across the country from the researchers point-of-view. Methods We employed an online IRB-RAT survey to measure perspectives of investigators towards IRB functions dealing with fairness issues, services, bias, and competences and upholding the rights of the human participants. Two responses were recorded: first shows how important an IRB function is for the investigator in his work, second shows how researchers rate their IRBs in being descriptive in that specific function. The difference of these two scores represent the outcome. Results We had 179 participants, 166(94%) researchers/research coordinators, and 13(7.2%) IRB members, 94 (53%) participants had been working in the research field for more than 11 years, and the majority 163(90%) revealed that they had IRB contact. The largest gap between actual rating and ideal was observed for the item “An IRB that requires that its chair be an experienced investigator” with a score difference of 1.53. In contrast, the smallest score difference was for the item “Considering the protection of human participants,” which had a score of 0.51. Conclusion According’s to researchers point of view; IRBs respect researchers, view human protections as a primary role, do not allow personal bias, maintain accurate records and take timely action whenever misconduct is reported. Further collaborations are needed to enhance IRB performance and to engage researchers in more productive communication with their IRBs.

Posterior reversible encephalopathy syndrome (PRES) is a serious neurological syndrome that may develop following immunosuppressive therapy for stem cell transplantation (SCT). We report 8 patients with sickle cell disease (SCD) who developed PRES, which is likely to be related to immunosuppression. This is retrospective cohort analysis of the SCD registry at the King Faisal Specialist Hospital and Research Center (KFSHRC) in Riyadh, Saudi Arabia. Inclusion criteria included all adults SCD patients who underwent SCT from 2011 until 2022. We explored all cases of PRES in patients with SCT. PRES was diagnosed with MRI imaging showing reversible vasogenic cerebral edema associated with neurological symptoms including severe headache, seizures, encephalopathy, delirium, and visual disturbances. During ten years follow-up (2011-2022) we found 8 patients with PRES (age range between 14 to 37 years at diagnosis) PRES occurred 8 to 124 days following SCT in 7 cases and one patient developed PRES 8 months prior to SCT. All patients were on immunosuppressive medications, including tacrolimus, cyclosporine, sirolimus and or mycophenolate mofetil. Headache, seizures, visual hallucinations, confusion, and drowsiness were the most common presenting symptoms. MRI showed abnormalities in the occipital, parietal and frontal lobes in most cases. Recovery was complete in all patients and no recurrences were noted. Two patients had graft versus host disease (GVHD). We compared risk factors for PRES among the 8 cases and 136 SCT in SCD patients who did not develop PRES. There was a significant association between PRES and imaging abnormalities, including previous bi-hemispheric infarctions (  = 0.001), and cerebral microbleeds (CBMs). PRES was strongly associated with presence (  = 0.006), size (  = 0.016) and number (  = 0.005) of CMBs. PRES can develop days to weeks following SCT in patients with SCD, and is associated with immunosuppressive therapy, previous bi-hemispheric infarctions and CMB. Prompt recognition and intervention leads to good recovery.

Introduction: Neurology senior residents and stroke fellows are first to clinically assess and interpret imaging studies of patients presenting to the emergency department with acute stroke. The aim of this study was to compare the diagnostic accuracy of brain CT angiography (CTA) with and without CT perfusion (CTP) between neurology senior residents and stroke fellows. Methods: In this neuroimaging study, nine practitioners (four senior neurology residents (SNRs) and five stroke fellows (SFs)) clinically assessed and interpreted the imaging data of 50 cases (15 normal images, 21 large vessel occlusions (LVOs) and 14 medium vessel occlusions (MeVOs) in two sessions, 1 week apart in comparison to final diagnosis of experienced neuroradiologist and experienced stroke neurologist consensus. Interrater agreement of CTA alone and CTA with CTP was quantified using kappa statistics, sensitivity, specificity and overall accuracy. Results: Overall, arterial occlusions were correctly identified in 221/315 (70.1%) with CTA alone and in 266/315 (84.4%) with CTA and CTP (p < 0.001). The sensitivity of overall arterial occlusions detection with CTA alone was 94.2% (95% CI: 90.8%–96.6%) while with addition of CTP was 98% (95% CI: 95.6%–99.3%), The specificity of CTA alone was 74.7% (95% CI: 67.2%–81.3%) which increased with CTP to 84.4% (95% CI: 77.7%–89.8%). The likelihood of correct identification with CTA alone was 156/189 (82.54%) for LVOs and 65/126 (51.59%) for MeVOs. This increased to 169/189 (89.42%; p = 0.054) for LVOs and 97/126 (76.98%; p < 0.001) for MeVOs when the CTA images with CTP were viewed. There was good overall interrater agreement between readers when using CTA alone (k 0.71, 95% CI, 0.62–0.80) and almost perfect (k 0.85, 95% CI, 0.76–0.94) when CTP was added to the image for interpretation. CTA and CTP had a significantly lower median interquartile range (IQR) interpretation time than CTA alone (114 [IQR, 103–120] s vs 156 [IQR, 133–160] s, p < 0.001). Discussion: In cerebral arterial occlusions, the rate of LVO and MeVOs detections increases when adding CTP to CTA. The accuracy and time for diagnosing arterial occlusion can be significantly improved if CTP is added to CTA. As MeVOs are commonly missed by front-line neurology senior residents or stroke fellows, cases with significant deficits and no apparent arterial occlusions need to be reviewed with neuroradiological expertise. Graphical abstract

Purpose: To investigate the role that intravascular thrombus volume plays in mechanical thrombectomy and dose-titrated algorithms using pharmaceutical thrombolytic therapies. Methods: The angiographic studies of 33 consecutive patients (19 women; mean age 66±11 years) who underwent endovascular treatment for acute ischemic stroke were reviewed. A double-injection technique was utilized that involved 2 catheters for simultaneous injection of contrast proximal and distal to the thrombus to delineate its boundaries. The thrombus volume was calculated using the formula for cylindrical objects after measuring its length and diameter. Results: The volume of the 36 thrombi measured in the study group was 46±59 mm3. The mean length and diameter were 10±6 and 2±1 mm, respectively. The time between symptom onset and acquisition of angiographic images ranged from 167 to 589 minutes (mean 336±109). In a multivariate analysis, thrombus volume was not associated with any recanalization (odds ratio 2.4, 95% CI 0.02–191) after adjusting for initial occlusion grade, time between symptom onset and angiography, and previous intravenous use of thrombolytic agents. Volume capacities for retrieval devices to retain 50% and 75% of the thrombi were estimated as 29.2 mm3 and 55.3 mm3, respectively. Conclusion: The large variation in thrombi volume must be considered in designing retrieval devices to optimize their performance.

Limited information exists regarding thrombolysis among anticoagulated acute stroke patients. We present data from three consecutive patients, on active warfarin therapy, treated with intra-arterial reteplase. All patients were screened for the presence of intracranial hemorrhage. Warfarin was reversed with fresh frozen plasma in all patients and cerebral angiography and intra-arterial administration of reteplase was performed. Computed tomographic scans were performed to detect any subsequent intracranial hemorrhage. Ages ranged from 58 to 79 years with initial National Institutes of Health Stroke Scale scores ranging from 12 to 17. Baseline international normalized ratios (INRs) were 1.99-2.25. None of the patients suffered from intracranial hemorrhage following thrombolysis, and two of the patients experienced early neurological improvement. Low dose, intra-arterial reteplase following acute reversal of elevated INR is feasible and may offer a potential treatment for patients suffering with acute ischemic stroke while receiving active warfarin treatment.

We describe a woman with congestive heart failure who presented with acute cardiac decompensation followed by ischemic stroke. The management of the patient posed unique challenges for thrombolytic treatment (due to existing coagulopathy) and subsequent optimization of hemodynamic status. Issues related to rethrombosis and use of platelet glycoprotein IIB/IIIA inhibitors are also discussed.