METHODS: This was a retrospective cohort study of severe or critical COVID-19 patients (≥18 years) admitted to one hospital in Kuwait. Fifty-one patients received intravenous tocilizumab, while 78 patients received the standard of care at the same hospital. Both groups were compared for clinical improvement and in-hospital mortality.
RESULTS: The tocilizumab (TCZ) group had a significantly lower 28-day in-hospital mortality rate than the standard-of care-group (21.6% vs. 42.3% respectively; p = 0.015). Fifty-five per cent of patients in the TCZ group clinically improved vs. 11.5% in the standard-of-care group (p over the 14 days of follow-up. Secondary infections occurred in 19.6% of the TCZ group, and in 20.5% of the standard-of-care group, with no statistical significance (p = 0.900).
CONCLUSION: Tocilizumab was significantly associated with better survival and greater clinical improvement in severe or critical COVID-19 patients.
METHODS: The most used methods for the quantification of Hb A2 are based on automated high performance liquid chromatography (HPLC) or capillary electrophoresis (CE). In particular Hb analyses were performed by HPLC on three dedicated devices. DNA analyses were performed according to local standard protocols.
RESULTS: Here, we described eight new δ-globin gene variants discovered and characterized in some laboratories in Northern Italy in recent years. These new variants were added to the many already known Hb A2 variants that were found with an estimated frequency of about 1-2% during the screening tests in our laboratories.
CONCLUSIONS: The knowledge recognition of the delta variant on Hb analysis and accurate molecular characterization is crucial to provide an accurate definitive thalassemia diagnosis, particularly in young subjects who would like to ask for a prenatal diagnosis or preimplantation genetic diagnosis.
METHODS: A cross-sectional study was conducted among HIV-infected individuals attending the main referral hospital in Jazan Region during the period 2017-2019. The participants' TB status, CD4+ lymphocyte count, and viral load were assessed. In addition, their demographic and clinical information was collected using a structured questionnaire.
RESULTS: A total of 316 HIV-positive individuals aged between 13 and 81 years (75% male and 25% female) were enrolled in this study. Of them, 30 (9.5%; 95% confidence interval [CI]: 5.2, 10.6%) were diagnosed with TB: 46.7% (14/30) had pulmonary TB and 53.3% (16/30) had extrapulmonary TB. The highest proportion of TB-positive PLWHA was found among participants aged 18-30 years (11.6%) and among non-Saudis (14.0%) when compared to other age groups and Saudi participants (7.4%). Multivariate analysis showed that male gender (adjusted odds ratio [AOR] = 4.79; 95% CI = 1.22, 18.74), past medical history (PMH) of TB (AOR = 29.67; 95% CI = 5.31, 164.32), PMH of other RTIs (AOR = 5.86; 95 % CI = 2.14, 16.06), CD4+ lymphocyte count of <200 cells/mm³ (AOR = 4.33; 95% CI = 1.65, 11.36), and viral load of ≥1 × 103 copies/mL (AOR = 5.46; 95% CI = 2.02, 14.77) were the significant risk factors of TB among the studied PLWHA.
CONCLUSION: The prevalence of TB/HIV co-infection among the studied population was 9.5%. Therefore, all PLWHA should be screened for TB at every visit to a health facility. The findings highlight that integration of health services for both TB and HIV/AIDS in Saudi Arabia is recommended.
TECHNIQUE: Under fluoroscopy, needle entry site and pathway are drawn according to the spinal anatomy. The needle is advanced toward the lateral recess and the needle tip is placed medially to the medial border of the pedicle under anteroposterior view and posteriorly to the posterior border of the upper endplate under lateral view. After checking optimal contrast spread, steroids and local anesthetics are injected.
CASE ILLUSTRATION: An 86-year-old woman who suffered from lower back pain with radiculopathy received interventional treatment. Comparing the "traditional" supraneural approach with the FLLR approach, the difference in contrast enhancement to lateral recess is clearly shown.
DISCUSSION: Compared to the pre-existing approaches, the FLLR approach may provide better ventral epidural and lateral recess enhancement. Furthermore, with the advanced needle tip, the injectate may enhance not only the at-level nerve root but also the nerve root of adjacent level during their existence in a single injection. With blunt needle usage, no nerve root injury or dura puncture was noted so far.
CONCLUSION: FLLR TFESI is a modified fluoroscopic technique targeted on lateral recess and anterior epidural space. However, subsequent trials are needed to confirm its efficacy in pain reduction and the rate of complications.
Objective: This study aims to determine inter-laboratory variation in HER2 IHC testing through a slide-exchange program between five main reference laboratories.
Method: A total of 20 breast carcinoma cases with different known HER2 expression and gene status were selected by the central laboratory in five testing rounds. Three unstained tissue sections from each case were sent to participating laboratories, which immunostained and interpreted the HER2 immunohistochemistry result. One of the stained slides was sent to one designated participating laboratory for evaluation. Results were analyzed by the central laboratory.
Results: A complete concordance was achieved in six IHC-positive and six IHC-negative cases, its gene status of which was confirmed by in-situ-hybridization (ISH) study. The discordant results were observed in six equivocal cases, one negative case and one positive case with a concordance rate of 50-88.3%. Interestingly, the negative discordant case actually displays tumor heterogeneity. Good inter-observer agreement was achieved for all participating laboratories (k = 0.713-1.0).
Conclusion: Standardization of HER2 testing method is important to achieve optimum inter-laboratory concordance. Discordant results were seen mainly in equivocal cases. Intra-tumoral heterogeneity may impact the final HER2 IHC scoring. The continuous quality evaluation is therefore paramount to achieve reliable HER2 results.
METHODS: A systematic review and meta-analysis were conducted in accordance with the PRISMA criteria. The PubMed, Science Direct, Web of Science, Scopus, Magiran, and Google Scholar databases were searched with no lower time limit up till 26 August 2020. The heterogeneity of the studies was measured using the I2 test, and the publication bias was assessed by the Begg and Mazumdar's test at the significance level of 0.1.
RESULTS: After following the systematic review processes, 86 studies were selected for meta-analysis. The sample size of the study was 103,334,579 people in the age range of 15-105 years. Using meta-analysis, the prevalence of osteoporosis in the world was reported to be 18.3 (95% CI 16.2-20.7). Based on 70 studies and sample size of 800,457 women, and heterogenicity I2: 99.8, the prevalence of osteoporosis in women of the world was reported to be 23.1 (95% CI 19.8-26.9), while the prevalence of osteoporosis among men of the world was found to be 11.7 (95% CI 9.6-14.1 which was based on 40 studies and sample size of 453,964 men.). The highest prevalence of osteoporosis was reported in Africa with 39.5% (95% CI 22.3-59.7) and a sample size of 2989 people with the age range 18-95 years.
CONCLUSION: According to the medical, economic, and social burden of osteoporosis, providing a robust and comprehensive estimate of the prevalence of osteoporosis in the world can facilitate decisions in health system planning and policymaking, including an overview of the current and outlook for the future; provide the necessary facilities for the treatment of people with osteoporosis; reduce the severe risks that lead to death by preventing fractures; and, finally, monitor the overall state of osteoporosis in the world. This study is the first to report a structured review and meta-analysis of the prevalence of osteoporosis worldwide.
OBJECTIVE: The purpose of this study was to develop a Falls Screening Mobile App (FallSA), determine its acceptance, concurrent validity, test-retest reliability, discriminative ability, and predictive validity as a self-screening tool to identify fall risk among Malaysian older persons.
METHODS: FallSA acceptance was tested among 15 participants (mean age 65.93 [SD 7.42] years); its validity and reliability among 91 participants (mean age 67.34 [SD 5.97] years); discriminative ability and predictive validity among 610 participants (mean age 71.78 [SD 4.70] years). Acceptance of FallSA was assessed using a questionnaire, and it was validated against a comprehensive fall risk assessment tool, the Physiological Profile Assessment (PPA). Participants used FallSA to test their fall risk repeatedly twice within an hour. Its discriminative ability and predictive validity were determined by comparing participant fall risk scores between fallers and nonfallers and prospectively through a 6-month follow-up, respectively.
RESULTS: The findings of our study showed that FallSA had a high acceptance level with 80% (12/15) of older persons agreeing on its suitability as a falls self-screening tool. Concurrent validity test demonstrated a significant moderate correlation (r=.518, P
MATERIALS AND METHODS: We searched the Pubmed, Medline, Embase and EBSCO databases for full-text, peer-reviewed journal publications from January 1965 to August 2020. Data extraction was done using preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.
RESULTS: Our search yielded 45 case reports involving 48 EMTM teeth. The mean age of the patients was 46.3 years with an age range of 22-80 years. Thirty-two cases were seen in women as compared to 13 cases in men. The majority of the cases (42) were unilateral, with only three bilateral cases. Among the 48 EMTM teeth, 21 were seen in the condylar region followed by 13 in the ramus, seven in the sigmoid notch, three in the angle and two each in the coronoid process and the lower border of the mandible. Twenty-five EMTM teeth had histopathologically confirmed dentigerous cysts, eight teeth had chronic infection/inflammation/granulation tissue, two had radicular cysts, two had infected cysts, two teeth had normal follicular spaces, and associated lesions were not mentioned for nine teeth. The most common symptoms were swelling (33 teeth) and pain (29 teeth), and six teeth were asymptomatic. Surgical removal through intraoral approach was carried out for 27 teeth, while an extra-oral approach was adopted in 15 teeth, a spontaneous regression of the pericoronal radiolucency was noticed in one tooth, four teeth were not treated and choice of treatment was not mentioned for one tooth. Mild transient paraesthesia was frequently observed; however, serious post-surgical complications were not reported.
CONCLUSIONS: The present review found that EMTM can present with complex clinicopathological characteristics, with a majority of the cases being asymptomatic in the beginning and turning out to be symptomatic with lesions at later stages, requiring surgical intervention.
METHODS: PARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI).
RESULTS: Overall, 190 patients with a median age of 61 years (range: 22.0-96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%).
CONCLUSIONS: Results of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.
METHODS: After baseline PET, patients were randomly assigned to an induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP). Repeat PET was performed after induction; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders (< 35% decrease in SUV) crossed over to the alternative chemotherapy during chemoradiation (50.4 Gy/28 fractions). PET responders (≥ 35% decrease in SUV) continued on the same chemotherapy during chemoradiation. Patients underwent surgery at 6 weeks postchemoradiation. Primary end point was pathologic complete response (pCR) rate in nonresponders after switching chemotherapy.
RESULTS: Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET. The pCR rates for PET nonresponders after induction FOLFOX who crossed over to CP (n = 39) or after induction CP who changed to FOLFOX (n = 50) was 18.0% (95% CI, 7.5 to 33.5) and 20% (95% CI, 10 to 33.7), respectively. The pCR rate in responders who received induction FOLFOX was 40.3% (95% CI, 28.9 to 52.5) and 14.1% (95% CI, 6.6 to 25.0) in responders to CP. With a median follow-up of 5.2 years, median overall survival was 48.8 months (95% CI, 33.2 months to not estimable) for PET responders and 27.4 months (95% CI, 19.4 months to not estimable) for nonresponders. For induction FOLFOX patients who were PET responders, median survival was not reached.
CONCLUSION: Early response assessment using PET imaging as a biomarker to individualize therapy for patients with esophageal and esophagogastric junction adenocarcinoma was effective, improving pCR rates in PET nonresponders. PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.
METHODOLOGY: Patients' socio-demographic and epidemiological data, clinical features, laboratory findings and clinical outcomes were extracted using a data sheet.
RESULTS: The median patient age was 25 [interquartile range (IQR)] 20-44) years, and most of patients were male (68.7%) and of Malaysian nationality (88.4%). Almost half of the patients were from a case cluster related to a religious event (48.3%) and 12.9% had a history of overseas travel. A total of 33.3% of patients were not related to any case cluster, i.e. sporadic cases. Radiological investigation showed that 13.6% of the patients had chest X-ray changes and all laboratory parameters were within the normal ranges. Sixty-six patients (44.9%) experienced symptoms. The most common symptoms were rhinitis (66.7%), followed by fever (19.7%) and cough (15.2%). Age, gender, case cluster, comorbidity status, haemoglobin, albumin, total protein, bilirubin total and alkaline phosphatase level were associated with symptomatic status.
CONCLUSIONS: In this single-centre study, COVID-19 infection led not only to case clusters, but also to sporadic infections, with patients being either symptomatic or asymptomatic. These sporadic cases and asymptomatic patients may hamper effective contact tracing, leading to rapid human-to-human transmission in our population. Future studies on the prevalence and clinical significance of asymptomatic and presymptomatic COVID-19 patients would pre-emptively address issues on further containment of the pandemic.
METHODS: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status.
RESULTS: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI, -12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI, -8.4% to 12.8%) for spot-sign negative participants (Pheterogenity=0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants (Pheterogenity=0.88).
CONCLUSIONS: Data from the TICH-2 trial do not support that admission spot sign status modifies the treatment effect of tranexamic acid versus placebo in patients with acute intracerebral hemorrhage. The results might have been affected by low statistical power as well as treatment delay. Registration: URL: http://www.controlled-trials.com; Unique identifier: ISRCTN93732214.
METHODS: We randomly allocated 180 older patients with significant morbidity (ASA physical status 3) ≥75 yr old to reversal of rocuronium with either SUG or NEO. Adverse events in the recovery room and pulmonary complications (defined by a 5-point [0-4; 0=best to 4=worst] outcome score) on postoperative Days 1, 3, and 7 were compared between groups.
RESULTS: Data from 168 patients aged 80 (4) yr were analysed; SUG vs NEO resulted in a reduced probability (0.052 vs 0.122) of increased pulmonary outcome score (impaired outcome) on postoperative Day 7, but not on Days 1 and 3. More patients in the NEO group were diagnosed with radiographically confirmed pneumonia (9.6% vs 2.4%; P=0.046). The NEO group showed a non-significant trend towards longer hospital length of stay across all individual centres (combined 9 vs 7.5 days), with a significant difference in Malaysia (6 vs 4 days; P=0.011).
CONCLUSIONS: Reversal of rocuronium neuromuscular block with SUG resulted in a small, but possibly clinically relevant improvement in pulmonary outcome in a select cohort of high-risk older patients.
CLINICAL TRIAL REGISTRATION: ACTRN12614000108617.