Budget impact of introducing oral semaglutide to the public healthcare benefit package in Saudi Arabia.

BACKGROUND: The Kingdom of Saudi Arabia (KSA) has embarked on a Health Sector Transformation Program as part of the Kingdom's Vision 2030 initiatives with the facilitation of access to healthcare services for the millions in KSA with diabetes an essential part of the Program. Decision-making tools, such as budget impact models, are required to consider the addition of new medications like oral semaglutide that have multifaceted health benefits and address barriers related to therapeutic inertia to reduce diabetes-related complications. OBJECTIVE: To determine the financial impact of the introduction of oral semaglutide as a treatment option for people with type 2 diabetes mellitus (T2DM) in KSA. METHODS: From the public payer's perspective, the budget impact model estimates the costs before and after the introduction of oral semaglutide over a 5-year time horizon. The budget impact of introducing oral semaglutide (primary comparator) compared with three different classes of diabetes medicines: glucagon-like peptide-1 receptor agonists (GLP-1), sodium-glucose transport protein 2 inhibitors (SGLT 2i) and dipeptidyl peptidase 4 inhibitors (DDP-4i) have been calculated based on the projected market shares. The model includes the cost of care through the incorporation of health outcomes that have an impact on the national payer's budget in Saudi Riyals (SAR). RESULTS: The budget impact over the five-year time horizon indicates a medication cost increase (17,424,788 SAR), and cost offsets which include a difference in diabetes management costs (-3,625,287 SAR), CV complications costs (-810,733 SAR) and weight loss savings of 453,936 SAR. The cumulative total cost difference is 12,427,858 SAR (0.66%). CONCLUSION: The introduction of oral semaglutide 14 mg as a second-line treatment option after metformin is indicated as budget-neutral to slightly budget-inflating for the public pharmaceutical formulary of KSA. The price difference is offset by positive health outcomes and costs. This conclusion was confirmed through a probabilistic sensitivity analysis.

Carpometacarpal dislocation second to fifth with associated hamate fracture: A case report of rare injury.

INTRODUCTION: Carpometacarpal (CMC) dislocation of the second to fifth metacarpals is an extremely rare hand injury that results from high-energy trauma. It is inherently unstable, especially if it is associated with concomitant carpal or metacarpal fractures. CASE PRESENTATION: We report the case of an 18-year-old male who sustained a motorbike injury at the level of the second to fifth CMC joints, which was associated with a hamate fracture. The patient failed initial conservative treatment, and so one week later he underwent closed reduction of the second to fifth carpometacarpal dislocations and Kirschner wire fixations from the second to fifth metacarpals. He then underwent open reduction and internal fixation of the hamate fracture using a mini-fragment plate and screws. DISCUSSION: This type of hand trauma is often overlooked due to radiological misinterpretations. It is important to pay attention to significant soft tissue swelling in this injury. Percutaneous pinning is still considered the gold standard and safest procedure for this injury. CONCLUSION: This is a rare hand injury that requires careful radiological assessment and meticulous and stable reduction. We believe that open reduction is advantageous in certain circumstances.

Urinary Bladder Hemangioma Successfully Treated by Angioembolization with Long-Term Follow-Up: Case Report and Literature Review.

Hemangiomas are benign blood vessel and capillary tumor growths which are widespread in many organs but extremely rare in the bladder, making up just 0.6% of all bladder tumors. To the best of our knowledge, few cases of bladder hemangioma are associated with pregnancy in the literature, and no bladder hemangiomas have been discovered incidentally after abortion. The use of angioembolization is well established; however, postoperative follow-up is crucial to identify tumor recurrence or residual disease. Case presentation: In 2013, a 38-year-old female was referred to a urology clinic with an incidental finding after an abortion of a large bladder mass identified incidentally using ultrasound (US). The patient was recommended for CT, which reported a polypoidal hypervascular lesion, as previously described arising from the urinary bladder wall. Diagnostic cystoscopy showed a large, bluish-red, pulsatile, vascularized submucosal mass with large dilated submucosal vessels, a wide-based stalk, and no active bleeding in the posterior wall of the urinary bladder, measuring about 2 × 3 cm, with negative urine cytology. Due to the vascular nature of the lesion and no active bleeding, the decision was made not to biopsy. The patient underwent angioembolization and scheduled for US every six months with regular diagnostic cystoscopy. In 2018, at 5 years of follow-up, the patient developed recurrence after a successful pregnancy. The angiography revealed recanalization of the previously embolized left superior vesical arteries from the anterior division of the left internal iliac artery, resulting in arteriovenous malformation (AVM). The second angioembolization was performed, with the total exclusion of AVM without residual. By the end of 2022, the patient had remained asymptomatic and without recurrence. Conclusion: Angioembolization is a safe treatment technique, minimally invasive, and has less effect on the quality of life, especially in young patients. Long-term follow-up is essential for detecting tumor recurrence or residual disease.

Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial.

PURPOSE: To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. METHODS: This is a pre-planned follow-up study of the Helmet-COVID trial. In this multicenter, randomized clinical trial, adults with acute hypoxemic respiratory failure (n = 320) due to coronavirus disease 2019 (COVID-19) were randomized to receive helmet noninvasive ventilation or usual respiratory support. The modified intention-to-treat population consisted of all enrolled patients except three who were lost at follow-up. The study outcomes were 180-day mortality, EuroQoL (EQ)-5D-5L index values, and EQ-visual analog scale (EQ-VAS). In the modified intention-to-treat analysis, non-survivors were assigned a value of 0 for EQ-5D-5L and EQ-VAS. RESULTS: Within 180 days, 63/159 patients (39.6%) died in the helmet noninvasive ventilation group compared to 65/158 patients (41.1%) in the usual respiratory support group (risk difference - 1.5% (95% confidence interval [CI] - 12.3, 9.3, p = 0.78). In the modified intention-to-treat analysis, patients in the helmet noninvasive ventilation and the usual respiratory support groups did not differ in EQ-5D-5L index values (median 0.68 [IQR 0.00, 1.00], compared to 0.67 [IQR 0.00, 1.00], median difference 0.00 [95% CI - 0.32, 0.32; p = 0.91]) or EQ-VAS scores (median 70 [IQR 0, 93], compared to 70 [IQR 0, 90], median difference 0.00 (95% CI - 31.92, 31.92; p = 0.55). CONCLUSIONS: Helmet noninvasive ventilation did not reduce 180-day mortality or improve HRQoL compared to usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

Effectiveness of a Single Chair Side Application of NovaMin® [Calcium Sodium Phosphosilicate] in the Treatment of Dentine Hypersensitivity following Ultrasonic Scaling-A Randomized Controlled Trial.

Dentinal hypersensitivity or cervical dentinal sensitivity is one of the commonest clinical problems. The aim of this randomized controlled trial was to evaluate the effectiveness of a single chair side application of 100% pure calcium sodium phosphosilicate (NovaMin®) in reducing dentin hypersensitivity following ultrasonic scaling as evaluated on a visual analogue scale (VAS). The study included 50 subjects who were selected based on an evaluation of dentinal hypersensitivity on a VAS carried out using a metered air blast from a three-way syringe and divided into two groups (n = 25/group); i.e., the test group (Group A) received the NovaMin® paste and the control group (Group B) received a placebo paste made from pumice. All the 50 subjects included in the study were had VAS scores of 3 or more. The NovaMin® powder mixed with distilled water was applied. Dentinal hypersensitivity was reassessed immediately and after 1, 2 and 4 weeks after the procedure. Results showed that the percentage reduction of dentinal hypersensitivity following a single application of NovaMin® in powder form was about 76.38% immediately, 67.72% one week postoperatively, 52.76% two weeks postoperatively and 26.78% four weeks postoperatively. It can be concluded from the results of the current clinical study demonstrated that a single chair side application of NovaMin® in powder form has a significant and immediate reduction in dentinal hypersensitivity, which lasted nearly for four weeks.

Effect of Injectable Platelet-Rich Fibrin with a Nano-Hydroxyapatite Bone Graft on the Treatment of a Grade II Furcation Defect.

Background: Periodontal diseases lead to bone loss, crestal defects and even loss of the tooth, which also further makes it difficult to replace the tooth. Autogenous bone grafts are considered the gold standard in bone regenerative procedures. This study aimed to compare and evaluate the bone regenerative effects of i-PRF (Injectable- Platelet-rich fibrin) with a bone graft and a bone graft alone in mandibular grade II furcation defects over a period of 9 months. Method: This was a comparative study of 12 participants, who were randomly selected and grouped into two groups: test and control. Following phase I therapy, both groups were subjected to open flap debridement. In the test group, after debridement, a nano-hydroxyapatite bone graft mixed with i-PRF was inserted, whereas in the control group only a nano-hydroxyapatite bone graft was inserted. The clinical parameters such as plaque index (PI), gingival index (GI), pocket probing depth (PPD), clinical attachment level (CAL), horizontal probing depth (HPD) and vertical probing depth (VPD) were recorded at baseline, 3 months, 6 months and 9 months following the surgery. The bone area fill (BAF) was assessed using intraoral periapical radiographs (IOPARs) taken at baseline and 9 months after surgery. Results: At the baseline, there was no statistically significant difference between the tested parameters. After 9 months all the clinical parameters, PI, GI, PPD, CAL, HPD and VPD as well as radiographic bone fill showed a significant increase in both the groups (p < 0.05) (PI-TGr; CGr−VPD­3.5 ± 0.54 to 0.66 ± 0.51; 3.3 ± 0.81 to 2 ± 0.63/BAF­2.9 ± 0.88 to 5.6 ± 1.10; 3.4 ± 1.39 to 3.9 ± 1.4). On comparison the test group showed better results for each clinical parameter. Conclusion: The results showed increased improvement in clinical conditions in both groups, although better results were seen in the group where i-PRF with a nano-HA bone graft was used in the furcation defect.

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial.

Importance: Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited. Objective: To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Design, Setting, and Participants: This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021. Interventions: Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen. Main Outcomes and Measures: The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events. Results: Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group. Conclusions and Relevance: Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04477668.

Prevalence, Causes, and Adverse Clinical Impact of Delayed Presentation of Non-COVID-19-Related Emergencies during the COVID-19 Pandemic: Findings from a Multicenter Observational Study.

Objective: The coronavirus disease (COVID-19) pandemic has disrupted healthcare systems worldwide, resulting in decreased and delayed hospital visits of patients with non-COVID-19-related acute emergencies. We evaluated the impact of the COVID-19 pandemic on the presentation and outcomes of patients with non-COVID-19-related medical and surgical emergencies. Method: All non-COVID-19-related patients hospitalized through emergency departments in three tertiary care hospitals in Saudi Arabia and Bahrain in June and July 2020 were enrolled and categorized into delayed and non-delayed groups (presentation ≥/=24 or <24 h after onset of symptom). Primary outcome was the prevalence and cause of delayed presentation; secondary outcomes included comparative 28-day clinical outcomes (i.e., 28-day mortality, intensive care unit (ICU) admission, invasive mechanical ventilation, and acute surgical interventions). Mean, median, and IQR were used to calculate the primary outcomes and inferential statistics including chi-square/Fisher exact test, t-test where appropriate were used for comparisons. Stepwise multivariate regression analysis was performed to identify the factors associated with delay in seeking medical attention. Results: In total, 24,129 patients visited emergency departments during the study period, compared to 48,734 patients in the year 2019. Of the 256 hospitalized patients with non-COVID-19-related diagnoses, 134 (52%) had delayed presentation. Fear of COVID-19 and curfew-related restrictions represented 46 (34%) and 25 (19%) of the reasons for delay. The 28-day mortality rates were significantly higher among delayed patients vs. non-delayed patients (n = 14, 10.4% vs. n = 3, 2.5%, OR: 4.628 (CI: 1.296−16.520), p = 0.038). Conclusion: More than half of hospitalized patients with non-COVID-19-related diagnoses had delayed presentation to the ED where mortality was found to be significantly higher in this group. Fear of COVID-19 and curfew restrictions were the main reasons for delaying hospital visit.

Knowledge, perception, and acceptance toward the booster dose of COVID-19 vaccine among patients visiting dental clinics in Aseer region of KSA.

Scientists have emerged with innovative research on non-human primates showing that the booster dose of the COVID-19 vaccine increases neutralizing antibody levels against all variants. The current cross-sectional survey was designed to evaluate the knowledge, perception, and acceptance of the booster dose of the COVID-19 vaccine among the patients visiting the various dental clinics in Aseer region, Kingdom of Saudi Arabia. A total of 609 dental patients were selected from various dental clinics by a simple random probability sampling method. The questionnaire was designed in multiple languages and categorized as demographic information, knowledge, perception, and acceptance of participants to a booster dose. An anonymous, self-administered, closed-ended online, and paper-based questionnaire was used to assess the above parameters. In the current survey, the majority of the participants were Saudis (80.8%) with an age mean of 37.7 ± 8.7 years. About 68.6% (418 out of 609) of participants had poor knowledge about the booster dose. Significant differences in the levels of knowledge were found in relation to gender, area of residency, education, nationality, and occupation. The distribution of level of perception of booster dose differs significantly among participants of different marital statuses and nationalities. Hesitation to booster was reported more in the rural than in the urban population. Despite a low level of knowledge, a higher level of good perception and acceptance of booster doses were reported among the studied population.

Comparative Evaluation of Locally Administered 2% Gel Fabricated from Lemongrass Polymer and 10% Doxycycline Hyclate Gel as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis-A Randomized Controlled Trial.

Background: Extracts of medicinal plant like lemongrass offer a new choice for optional antimicrobial therapy against various oral microorganisms. The objective of this study was to assess, verify, and compare the antimicrobial effectiveness of locally administered 2% lemongrass gel and 10% doxycycline hyclate gel as an adjunct to scaling and root planing (SRP) in treating chronic periodontitis. Method: This is a double-blind parallel arm randomized controlled study. Forty subjects were randomly divided into Group A and B for 2% lemongrass gel and 10% doxycycline hyclate gel, respectively. The clinical assessments of Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL) together with microbial colony counts for Porphyromonas gingivalis, Actinomyces naeslundii, and Prevotella intermedia were done at baseline, 1st month, and 3rd month follow-ups. Results: The results showed there was a significant reduction in the mean scores of GI, PPD, and CAL clinical indices from baseline to the 1st and 3rd month follow-ups in both the 2% lemongrass gel and 10% doxycycline gel groups (p < 0.05). Similarly, there was significant reduction in mean CFU scores for all periodontal pathogens from baseline to 1st and 3rd month follow-ups in both the 2% lemongrass gel and 10% doxycycline gel groups (p < 0.05). Conclusions: It could be concluded that the local delivery of 2% lemongrass gel as an adjunct to scaling and root planing is effective and comparable to 10% doxycycline gel in the treatment of chronic periodontitis.

Pre-hospital airway management and survival outcomes after paediatric out-of-hospital cardiac arrests.

BACKGROUND: Paediatric out-of-hospital cardiac arrest (OHCA) results in high mortality and poor neurological outcomes. We conducted this study to describe and compare the effects of pre-hospital airway management on survival outcomes for paediatric OHCA in the Asia-pacific region. METHODS: We performed a retrospective analysis of the Pan Asian Resuscitation Outcomes Study (PAROS) data from January 2009 to June 2018. PAROS is a prospective, observational, multi-centre cohort study from eleven countries. The primary outcomes were one-month survival and survival with favourable neurological status, defined as Cerebral Performance Category1 or 2. We performed multivariate analyses of the unmatched and propensity matched cohort. RESULTS: We included 3131 patients less than 18 years in the study. 2679 (85.6%) children received bag-valve-mask (BVM) ventilations, 81 (2.6%) endotracheal intubations (ETI) and 371 (11.8%) supraglottic airways (SGA). 792 patients underwent propensity score matching. In the matched cohort, advanced airway management (AAM: SGA and ETI) when compared with BVM group was associated with decreased one-month survival [AAM: 28/396 (7.1%) versus BVM: 55/396 (13.9%); adjusted odds ratio (aOR), 0.46 (95% CI, 0.29 - 0.75); p = 0.002] and survival with favourable neurological status [AAM: 8/396 (2.0%) versus BVM: 31/396 (7.8%); aOR, 0.22 (95% CI, 0.10 - 0.50); p < 0.001]. For SGA group, we observed less 1-month survival [SGA: 24/337 (7.1%) versus BVM: 52/337 (15.4%); aOR, 0.41 (95 %CI, 0.25-0.69), p = 0.001] and survival with favourable neurological status. CONCLUSION: In children with OHCA in the Asia-Pacific region, pre-hospital AAM was associated with decreased one-month survival and less favourable neurological status.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial.

BACKGROUND: Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited. METHODS: In this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk  and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait. DISCUSSION: We developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020.

International multi-center real world implementation trial to increase out-of-hospital cardiac arrest survival with a dispatcher-assisted cardio-pulmonary resuscitation package (Pan-Asian resuscitation outcomes study phase 2).

BACKGROUND: Dispatcher-assisted CPR (DA-CPR) has the potential to deliver early bystander CPR (BCPR) and improve out-of-hospital cardiac arrest (OHCA) survival. This study in the Asia-Pacific evaluated the impact of a DA-CPR program on BCPR rates and survival. METHODS: This was a three-arm, prospective, multi-national, population-based, community-level, implementation trial. Cases between January 2009 and June 2018 from the Pan-Asian Resuscitation Outcomes Study were included. Sites either implemented a comprehensive (with quality improvement tool) or a basic DA-CPR package, or served as controls. Primary outcome was survival-to-discharge/30th day post-arrest. Secondary outcomes were BCPR and favorable neurological outcome. A before-after comparison was made within each country; this before-after change was then compared across the three groups using logistic regression. RESULTS: 170,687 cases were analyzed. Before-after comparison showed that survival to discharge was higher in the 'implementation' period in all three groups: comprehensive odds ratio (OR) 1.09, 95% confidence interval (CI; [1.0-1.19]); basic OR 1.14, 95% CI (1.08-1.2); and control OR 1.25, 95% CI (1.02-1.53). Comparing between groups, the comprehensive group had significantly higher change in BCPR (comprehensive vs control ratio of OR 1.86, 95% CI [1.66-2.09]; basic vs control ratio of OR 0.94, 95% CI [0.85-1.05]; and comprehensive vs basic ratio of OR 1.97, 95% CI [1.87-2.08]) and survival with favorable neurological outcome (comprehensive vs basic ratio of OR 1.2, 95% CI [1.04-1.39]). CONCLUSION: We evaluated the impact of a DA-CPR program across heterogeneous EMS systems and demonstrated that a comprehensive DA-CPR program had the most impact on BCPR and favorable neurological outcome.

The association between Annexin A2 and epithelial cell adhesion molecule in breast cancer cells.

BACKGROUND: The epithelial cell adhesion molecule (EpCAM) is a type I transmembrane and glycosylated protein, which is overexpressed in many neoplasms. However, EpCAM has no known ligand partners and the mechanisms by which it functions are not fully understood. AIM: This study was performed to discover novel partners of EpCAM, which may provide a better understanding of its functions. METHODS: The membrane fraction of the ERα+ noninvasive breast cancer cell line ZR-75-1 and MCF-7 was extracted and followed by co-immunoprecipitation of EpCAM using C-10, a mouse monoclonal antibody raised against amino acids 24-93 of the EpCAM molecule. As a negative control, MDA-MB-231 and Hs578T were used since they express a negligible amount of EpCAM and are known as EpCAM-/low ERα-/low invasive and tumorigenic breast cancer cell lines. RESULTS: Annexin A2 (ANXA2) was found to be selectively and differentially co-immunoprecipitated with EpCAM in the ERα+ breast cancer cells MCF-7 and ZR-75-1. ANXA2 is a multifunctional protein and known to act as a co-receptor for tissue plasminogen activator (tPA) on the surface of endothelial and cancer cells, thereby affecting fibrinolytic activity and neoangiogenesis as well as invasive and metastatic properties. In this study, the association between EpCAM and ANXA2 was found to affect the activity of tPA. CONCLUSION: This study concludes that ANXA2 co-localizes with EpCAM at the plasma membrane, and the co-localization may have functional implications. Data suggest that EpCAM supports ANXA2 to function as a co-receptor for the tPA, and that EpCAM has a regulatory function on the expression and subcellular localization of ANXA2.

Successful Endovascular Repair of Infectious External Iliac Artery Anastomotic Pseudoaneurysm With Graft Preservation Post-Kidney Transplantation: Case Report and Review of Literature.

BACKGROUND: Allograft artery-infected pseudoaneurysm (PA) represents a rare but life-threatening complication of kidney transplantation (KT). A review of the literature, showed that nearly all these cases ended resulted in graft loss. We presented a case of post-KT-infected external iliac artery anastomotic PA successfully managed by endovascular stenting with graft preservation. Additionally, we reviewed the pertinent literature. METHOD: In this article, we described a hypertensive, 47-year-old man who presented 1 month post-cadaveric KT with acute kidney injury and gram-negative bacteremia secondary to a large infectious anastomotic PA of the external iliac artery. RESULTS: Because of favorable anatomy, successful arterial angio-stent fixation of the main renal artery PA, sparing the lower polar artery, was performed after 1 week of antibiotic and fungal coverage. CONCLUSION: Patient was discharged after 2 weeks with functioning graft. Graft function was stable after 3 months.

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality. METHODS: The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of "possible sepsis alert" to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days. DISCUSSION: The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality. METHODS AND ANALYSIS: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. ETHICS AND DISSEMINATION: Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings. TRIAL REGISTRATION NUMBER: NCT04477668.

Surgical treatment of humeral head avascular necrosis in patients with sickle cell disease: a systematic review.

BACKGROUND: Sickle cell disease is the leading etiology for atraumatic humeral head avascular necrosis worldwide. Treatment of this condition is not standardized, with only few studies evaluating clinical outcomes after surgical interventions. The aim of this study was to review the available evidence on the results of surgical intervention for humeral head avascular necrosis in the sickle cell disease population. METHODS: A systematic electronic search was conducted using PubMed (MEDLINE), EMBASE, and Cochrane Library databases. Relevant studies that reported the outcomes of surgical intervention for humeral head avascular necrosis for patients with sickle cell disease were reviewed. Outcome parameters were pain, range of motion, specific shoulder outcome scores, and complications. RESULTS: Six studies, three retrospective cohorts (2 level III and 1 level IV) and three case series (level IV), were included in this review. A total of forty-three patients with sickle cell disease, comprising forty-nine shoulders, underwent different surgical procedures. Surgical procedures were core decompression, arthroscopic intervention, humeral head resurfacing, shoulder hemiarthroplasty, and total shoulder arthroplasty. CONCLUSION: Surgical intervention for humeral head avascular necrosis in patients with sickle cell disease is selected based on the osteonecrosis stage. In the precollapse stage, core decompression is regarded as the first surgical option. However, in the light of current evidence, it has not been confirmed to prevent or delay natural progression of the disease. Shoulder arthroplasty is reserved for late stages, which despite the fairly good outcomes, data for long-term implant survival and complications are not well documented.

Assessment of risk factors for bone fractures in patients with type 2 diabetes mellitus: A study in Saudi Arabia.

BACKGROUND AND AIMS: This study aimed to estimate the prevalence of bone fractures and analyze their associated risk factors in people with and without type 2 diabetes (T2D) in Saudi Arabia. METHODS: This study was conducted among 1188 people (581 type 2 diabetes) in Prince Sultan Military Medical City, Riyadh, Saudi Arabia. In addition to the demographic variables, glycated hemoglobin (HbA1c), creatinine, estimated glomerular filtration rate (eGFR), use of teriparatide, presence of rheumatoid arthritis, presence of chronic obstructive pulmonary disease (COPD), Bone mineral density (BMD), Trabecular Bone Score (TBS) and Fracture Risk using the Fracture Risk Assessment Tool (FRAX) were also collected. RESULTS: There were 1188 people (mean age 66.5 ± 8.7yrs) included in this study, of which 1068 (89.9%) were female, and 120 (10.1%) were male. A total of 112 (9.4%) individuals had a fracture history. Female, use of teriparatide, TBS (partially degraded and degraded), FRAX with TBS (MOF), and FRAX with TBS (Hip fx) were identified as independent risk factors for fracture in the whole study population. Teriparatide use and FRAX with TBS (MOF) were observed as independent risk factors for fracture in the non-diabetic population, whereas age, creatinine, eGFR, teriparatide, osteopenia, osteoporosis, TBS (partially degraded, degraded), FRAX with TBS (MOF), FRAX with TBS (Hip fx) were determined as independent risk factors for fracture among patients with diabetes. CONCLUSION: Patients with T2D were observed to have a higher risk for fractures. The findings of the study highlight the requirement for fracture prevention strategies in patients with diabetes.

Impact of critical care response team implementation on oncology patient outcomes: A retrospective cohort study.

INTRODUCTION: The main goal of a critical care response team (CCRT) is to quickly assess and transfer, if required, rapidly deteriorating patients to an intensive care unit (ICU) to prevent cardiopulmonary arrest, stabilize patients' condition, and help in optimizing the care provided by the primary team. The objective of this study was to investigate the correlation between early intervention by CCRT and the outcome of oncology patients. MATERIALS AND METHODS: This is a retrospective cohort study conducted at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. KAMC is a tertiary care facility with 1200-bed capacity. The study compared oncology patients to nononcology patients. RESULTS: Over 4 years, a total number of 4941 patients were reviewed, of which 172 were oncology patients. The average age of patients in the oncology group was 48.8 ± 20.7, while the average age for nononcology was 52.8 ± 21.2 (P = 0.016). The average Acute Physiology and Chronic Health Evaluation II score on admission for oncology patients was higher than that for the nononcology group (27.8 ± 8.9 vs. 23.6 ± 9.3, respectively). Lower ICU mortality was seen after CCRT implementation (38.8% vs. 62.7%). The average duration of hospital stay and ICU stay increased after CCRT implementation (37.34 vs. 29.31 and 11.93 vs. 8.9, respectively). CONCLUSION: In this study, we identified that early intervention by implementing CCRT had a significant impact in reducing ICU mortality for oncology and nononcology patients.