An Epidemiological and Clinical Analysis of Cutaneous Adverse Drug Reactions Seen in a Tertiary Care Outpatient Clinic in Cairo, Egypt

A cutaneous adverse drug reaction (CADR) is any undesirable change in the structure or function of the skin, its appendages, or mucous membranes caused by a drug. The frequency of CADRs is variable, with only few studies evaluating it. Our aim was to identify the clinical spectrum of CADRs and document the epidemiological data of different types of drug eruptions among Egyptian patients attending a tertiary care center. An observational hospital-based analytical study was planned for a period of six months (January-June 2015). All patients attending the outpatient Dermatology Clinic at Kasr El Aini hospital were examined to detect patients with CADRs, who were subjected to a detailed questionnaire with a detailed drug history. A skin biopsy was taken to confirm the diagnosis and to detect the type of CADRs. The primary incidence of CADRs reported in our study was 0.28% (78 patients) from a total number of 27,093 patients. The most common CADRs were SJS/TEN in 12 patients (15.3%) and lichenoid drug eruptions in 12 patients (15.3%), followed by exanthematous drug eruptions in 11 patients (14.1%) and vasculitic drug eruptions in 9 patients (11.5%). The most common drug incriminated was ibuprofen in 6 patients (7.6%), followed by penicillin in 4 patients (5.1%) and aspirin in 3 patients (3.8%). In conclusion, incidence of CADRs in our study was similar to incidence reported in different countries; however, the incidence of life-threatening reactions such as SJS/TEN was higher compared with studies conducted abroad.</p

An Epidemiological and Clinical Analysis of Cutaneous Adverse Drug Reactions Seen in a Tertiary Care Outpatient Clinic in Cairo, Egypt

A cutaneous adverse drug reaction (CADR) is any undesirable change in the structure or function of the skin, its appendages, or mucous membranes caused by a drug. The frequency of CADRs is variable, with only few studies evaluating it. Our aim was to identify the clinical spectrum of CADRs and document the epidemiological data of different types of drug eruptions among Egyptian patients attending a tertiary care center. An observational hospital-based analytical study was planned for a period of six months (January-June 2015). All patients attending the outpatient Dermatology Clinic at Kasr El Aini hospital were examined to detect patients with CADRs, who were subjected to a detailed questionnaire with a detailed drug history. A skin biopsy was taken to confirm the diagnosis and to detect the type of CADRs. The primary incidence of CADRs reported in our study was 0.28% (78 patients) from a total number of 27,093 patients. The most common CADRs were SJS/TEN in 12 patients (15.3%) and lichenoid drug eruptions in 12 patients (15.3%), followed by exanthematous drug eruptions in 11 patients (14.1%) and vasculitic drug eruptions in 9 patients (11.5%). The most common drug incriminated was ibuprofen in 6 patients (7.6%), followed by penicillin in 4 patients (5.1%) and aspirin in 3 patients (3.8%). In conclusion, incidence of CADRs in our study was similar to incidence reported in different countries; however, the incidence of life-threatening reactions such as SJS/TEN was higher compared with studies conducted abroad.</p

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Splenomegaly versus pathological lung volume during COVID-19 infection with or without cytokine storm; a linear regression analysis using CT volumetry

Background: Due to the paucity of scientific evidence, it is unclear among pulmonologists and physicians in critical care units if and when splenomegaly in novel coronavirus disease (2019) (COVID-19) patients is worrisome. This study aims to evaluate the significance of splenic volume during COVID-19 infection with or without cytokine storm and correlates splenic volume to the volume of pathological lung changes through linear regression analysis. Results: A retrospective study collected 509 polymerase chain reaction proved COVID-19 patients (399 males, 110 females; mean age 48 years, age range 24-78 years) between June and November 2021, without a history of splenic pathology. A control group of age and sex-matched 509 healthy subjects was used and analyzed according to the splenic volume. Five consulting radiologists evaluated initial and follow-up computed tomography (CT) examinations using lung CT volumetry and splenic volume calculation in consensus. Three consulting pulmonologists correlated the severity of clinical and laboratory findings, including oxygen requirements and interleukin-6 (IL-6) levels. The T test results for comparison between the COVID-19 patients and the healthy subjects control group regarding the splenic volume were significant (Tvalue was - 4.731452 and p value was 0.00002). There was no significant correlation between the severity of the disease and normal-sized spleen (26% of patients, p= 0.916) or splenomegaly (24% of patients, p= 0.579). On the other hand, all patients with a small spleen or progressive splenomegaly during serial follow-up imaging had clinically severe disease with a statistically significant correlation (p= 0.017 and 0.003, respectively). Ninety-seven percent of patients with clinically mild disease and splenomegaly had 0-20% lung involvement (CT-severity score 1) while all patients with clinically severe disease and splenomegaly had 27-73% lung involvement (CT-severity score 2 and 3) (r = 0.305, p = 0.030). Conclusions: Splenomegaly is a non-specific sign that may be found during mild and severe COVID-19 infection, it was not statistically correlated with the clinical severity and a weak positive relationship was found between the splenic size and the CT-severity score of the pathological lung volume. On the other hand, the presence of splenic atrophy or progressive splenomegaly was correlated with severe COVID-19 presentation and "cytokine storm". Therefore, the splenic volume changes should not be overlooked in COVID-19 serial CT examinations, particularly in severe or critically ill patients with cytokine storms

Primary Evaluation of Shape Recovery of Orthodontic Aligners Fabricated from Shape Memory Polymer (A Typodont Study)

As an innovative approach to overcome the rate-limiting staging of conventional aligners, using shape memory polymers (SMPs) as aligners’ materials was investigated in this in vitro study. The ability of SMPs to shape recover and consequently move tooth, upon appropriate stimuli, was evaluated on a typodont model before clinical application. The study design was to achieve 1.9 mm correction movement of an upper central incisor by one aligner after multiple steps/activation. A custom-made aligned typodont model with a movable upper central incisor was scanned. Using an orthodontic software and a 3D printer, resin-models were generated. Seven aligners of ClearX sheets (SMPs) were fabricated by thermoforming on the resin aligned model. Each aligner was tested for repositioning of the central incisor in the typodont model. The model was scanned after each step and the corrective movement was measured through the superimposition of scans. Results showed that the total correction efficiency of the SMPs’ aligner was ≈93% (1.76 mm). The corrective movement was 0.94 ± 0.04 mm after the reforming step, 0.66 ± 0.07 mm after the first activation step, and 0.15 ± 0.10 mm after the second activation step. It was concluded that aligners made of SMPs could have a promising future-use in orthodontic aesthetic treatment

Maternal and neonatal safety outcomes after SAR-CoV-2 vaccination during pregnancy: a systematic review and meta-analysis

Abstract Background and objective More than five million individuals died because of problems connected to COVID-19. SARS-Cov-2 poses a particular challenge to expectant mothers, who comprise one of the most vulnerable segments of the population. Our aim is to demonstrate the maternal and neonatal safety of the COVID-19 vaccine during pregnancy. Methods We searched PubMed, Cochrane Library, Scopus, Web of Science (WOS), Embase, Ovid, MedRxiv, and BioRxiv databases from inception till December 2021 and then updated it in April 2022. Additionally, we searched ClinicalTrials.gov, Research Square and grey literature. Cohort, case–control studies, and randomized controlled trials detecting the safety of the Covid-19 vaccine during pregnancy were included. We used the Cochrane tool and Newcastle–Ottawa Scale to assess the risk of bias of the included studies and the GRADE scale to assess the quality of evidence. A meta-analysis was conducted using review manager 5.4. Results We included 13 studies with a total number of 56,428 patients. Our analysis showed no statistically significant difference in the following outcomes: miscarriage (1.56% vs 0.3%. RR 1.23; 95%CI 0.54 to 2.78); length of maternal hospitalization (MD 0.00; 95%CI -0.08 to 0.08); puerperal fever (1.71% vs 1.1%. RR 1.04; 95%CI 0.67 to 1.61); postpartum hemorrhage (4.27% vs 3.52%. RR 0.84; 95%CI 0.65 to 1.09); instrumental or vacuum-assisted delivery (4.16% vs 4.54%. RR 0.94; 95%CI 0.57 to 1.56); incidence of Apgar score ≤ 7 at 5 min (1.47% vs 1.48%. RR 0.86; 95%CI 0.54 to 1.37); and birthweight (MD -7.14; 95%CI -34.26 to 19.99). Conclusion In pregnancy, the current meta-analysis shows no effect of SAR-CoV-2 vaccination on the risk of miscarriage, length of stay in the hospital, puerperal fever, postpartum hemorrhage, birth weight, or the incidence of an Apgar score of ≤ 7 at 5 min

Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries

© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 licenseBackground: 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods: This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov, NCT03471494. Findings: Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation: Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding: National Institute for Health Research Global Health Research Unit

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23–0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research