scholarly journals Adverse events in emergency oncological spine surgery: a prospective analysis

2014 ◽  
Vol 21 (5) ◽  
pp. 698-703 ◽  
Author(s):  
Nicolas Dea ◽  
Anne Versteeg ◽  
Charles Fisher ◽  
Adrienne Kelly ◽  
Dennis Hartig ◽  
...  

Object Most descriptions of spine surgery morbidity and mortality in the literature are retrospective. Emerging prospective analyses of adverse events (AEs) demonstrate significantly higher rates, suggesting underreporting in retrospective and prospective studies that do not include AEs as a targeted outcome. Emergency oncological spine surgeries are generally palliative to reduce pain and improve patients' neurology and health-related quality of life. In individuals with limited life expectancy, AEs can have catastrophic implications; therefore, an accurate AE incidence must be considered in the surgical decision-making process. The purpose of this study was to determine the true incidence of AEs associated with emergency oncological spine surgery. Methods The authors carried out a prospective cohort study in a quaternary care referral center that included consecutive patients admitted between January 1, 2009, and December 31, 2012. Inclusion criteria were all patients undergoing emergency surgery for metastatic spine disease. AE data were reported and collected on standardized AE forms (Spine AdVerse Events Severity System, version 2 [SAVES V2] forms) at weekly dedicated morbidity and mortality rounds attended by attending surgeons, residents, fellows, and nursing staff. Results A total of 101 patients (50 males, 51 females) met the inclusion criteria and had complete data. Seventysix patients (76.2%) had at least 1 AE, and 11 patients (10.9%) died during their admission. Intraoperative surgical AEs were observed in 32% of patients (9.9% incidental durotomy, 16.8% blood loss > 2 L). Transient neurological deterioration occurred in 6 patients (5.9%). Infectious complications in this patient population were significant (surgical site 6%, other 50.5%). Delirium complicated the postoperative period in 20.8% of cases. Conclusions When evaluated in a rigorous prospective manner, metastatic spine surgery is associated with a higher morbidity rate than previously reported. This AE incidence must be considered by the patient, oncologist, and surgeon to determine appropriate management and preventative strategies to reduce AEs in this fragile patient population.

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.


2020 ◽  
Author(s):  
BHAVIN VASAVADA ◽  
Hardik Patel

UNSTRUCTURED All the gastrointestinal surgeries performed between April 2016 to march 2019 in our institution have been analysed for morbidity and mortality after ERAS protocols and data was collected prospectively. We performed 245 gastrointestinal and hepato-biliary surgeries between April 2016 to march 2019. Mean age of patients was 50.96 years. 135 were open surgeries and 110 were laparoscopic surgeries. Mean ASA score was 2.40, mean operative time was 111 minutes, mean CDC grade of surgery was 2.56. 40 were emergency surgeries and 205 were elective surgeries. Overall 90 days mortality rate was 8.5% and over all morbidity rate was around 9.79% . On univariate analysis morbidity was associated significantly with higher CDC grade of surgeries, higher ASA grade, more operative time, more blood products use, more hospitalstay, open surgeries,HPB surgeries and luminal surgeries(non hpb gastrointestinal surgeries) were associated with higher 90 days morbidity. On multivariate analysis no factors independently predicted morbidity. On univariate analysis 90 days mortality was predicted by grade of surgeries, higher ASA grade, more operative time, more blood products use, open surgeries and emergency surgeries. However on multivariate analysis only more blood products used was independently associated with mortality There is no difference between 90 day mortality and moribidity rates between open and laparoscopic surgeries.


Author(s):  
Mustafa Emin Canakci ◽  
Cengiz Ovali ◽  
İrem Aydogdu ◽  
Betul Tiryaki Bastug ◽  
Obaidullah Ahmadzai ◽  
...  

Abstract Atrioesophageal fistula (AEF) is an important complication of radiofrequency ablation (RFA). Delayed diagnosis is associated with increased morbidity and mortality. Despite the name “atrioesophageal fistula,” fistulas functionally act esophageal to atrial, which accounts for the neurologic and infectious complications. This report presents the management of a 60-year-old male patient who was admitted to the emergency department (ED) with AEF-caused gastrointestinal bleeding. The patient was operated urgently, but he had serious comorbidities and died after the operation. The aim of this case was to evaluate patients who underwent RFA, within 10 days to two months, carefully in the ED and to know the possible complications.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1433.1-1433
Author(s):  
J. G. Rademacher ◽  
V. Korendovych ◽  
P. Korsten

Background:The anti-CD20 antibody rituximab (RTX) is approved for the treatment of rheumatoid arthritis (RA) and ANCA-associated vasculitis (AAV). In addition, RTX is used in a wide range of autoimmune diseases. Belimumab (BEL) is an anti-BAFF antibody approved for the treatment of non-renal systemic lupus erythematosus (SLE) in Europe. These agents are generally well-tolerated but severe adverse events (AEs) can occur. The frequency of and factors associated with AEs are currently unknown.Objectives:To identify adverse events with the use of B-cell directed therapies in a large population of RA, AAV, and SLE.Methods:This is a single-center retrospective cohort study using routine clinical data over a ten-year period (2010-2020). We recorded epidemiological and clinical data of patients receiving either BEL or RTX. Data included age, gender, type of disease, number and efficacy of infusions, patient-years and concomitant treatment. Patient records were screened for AEs, such as infections, anaphylaxis, occurrence of malignant disease, laboratory abnormalities and immunoglobulin (Ig) deficiency. Between group comparisons were performed.Results:Database screening yielded 445 patients treated with RTX and 23 with BEL. After exclusion of patients with incomplete data, 425 RTX and 23 BEL patients were analyzed.Our preliminary analysis of a sample of 60 of these 448 patients (184 patient-years) resulted in 43 patients (72%) with RA, 8 patients with AAV (13%), 5 patients with a renal disease, and 4 patients with mixed connective tissue disease, as well 23 SLE patients. 46 (77%) were female. In RA, a median of 13 treatments of 1000 mg were administered, corresponding to 3.37 patient-years per patient. Primary non-response occurred in 2 patients, secondary non-response in 13 patients. For AAV, a median of 8.4 treatments were given (3.3 patient-years), no treatment failure was detected. SLE patients received a median of 15 treatments.15 patients had infectious complications during treatment, 11 needed treatment. Herpes zoster infection occurred in 3 patients with RA. Three of the 8 patients with AAV had an infection requiring treatment. In SLE patients, only 2 developed infectious complications, and no Ig-deficiency occurred.Lymphopenia was the most common laboratory abnormality detected in 25 patients with RTX, 19 of whom had RA. Ig deficiency was common in RA, affecting 30% of patients. Deficiency of IgM and IgG was recognized in 5 patients each; 1 patient had low levels IgA.Neither the maintenance prednisolone dosage nor Ig deficiency were associated with risk for infection. However, lymphopenia appeared to be associated with risk for infection.Conclusion:Our preliminary data observe a 184 patient-year period. RTX and BEL were generally associated with few AEs. RA patients frequently had laboratory abnormalities (lymphopenia, Ig-deficiency) which did not necessarily translate to clinical events. Infections were more common in AAV, BEL was the best tolerated B-cell directed agent. Overall, our data are reassuring, but we suggest a more careful vigilance in AAV patients.Disclosure of Interests:Jan-Gerd Rademacher: None declared, Viktor Korendovych: None declared, PETER KORSTEN Speakers bureau: Abbvie, Sanofi Aventis, GSK, Chugai, Boehringer-Ingelheim, Novartis, Consultant of: Lilly, Gilead, Boehringer-Ingelheim, Novartis, GSK, Grant/research support from: GSK


2009 ◽  
Vol 89 (5) ◽  
pp. 443-455 ◽  
Author(s):  
Stefania Costi ◽  
Mauro Di Bari ◽  
Paolo Pillastrini ◽  
Roberto D'Amico ◽  
Ernesto Crisafulli ◽  
...  

Background, Objectives, and Measurements Patients with chronic airway obstruction (CAO) frequently experience dyspnea and fatigue during activities performed by accessory muscles of ventilation, which competitively participate in arm elevation. This systematic review of randomized controlled trials (RCTs) concerning patients with CAO addresses the effects of upper-extremity exercise training (UEET), added to lower-extremity training or comprehensive pulmonary rehabilitation, on the following patient-centered outcomes: exercise capacity, symptoms, ability to perform daily activities, and health-related quality of life. Methods Studies were retrieved using comprehensive database and hand-search strategies. Two independent reviewers determined study eligibility based on inclusion criteria. A detailed description of treatments was mandatory. Reviewers rated study quality and extracted information on study methods, design, intervention, and results. Results Forty publications were evaluated. Four RCTs met the inclusion criteria but had serious methodological limitations, which introduce possible biases that reduce their internal validity. The outcomes measured were heterogeneous, and the results were inconsistent regarding maximal exercise capacity, dyspnea, and health-related quality of life. No effect of UEET was demonstrated for measures of arm fatigue. Limitations and Conclusions The limited methodological quality of the studies retrieved prevented us from performing a meta-analysis, the results of which could be misleading. This systematic review shows that there is limited evidence examining UEET and that the evidence available is of poor quality. Therefore, a recommendation for the inclusion or exclusion of UEET in pulmonary rehabilitation programs for individuals with CAO is not possible. Further research is needed to definitively ascertain the effects of this training modality on patient-centered outcomes.


2014 ◽  
Vol 41 (12) ◽  
pp. 2452-2458 ◽  
Author(s):  
Michelle Batthish ◽  
Shirley M.L. Tse ◽  
Brian M. Feldman ◽  
G. Ross Baker ◽  
Ronald M. Laxer

Objective.To describe the frequency and types of reported adverse events and system improvement recommendations in the Morbidity and Mortality Conference (M&MC) within the Division of Rheumatology at The Hospital for Sick Children, Toronto, Ontario, Canada (SickKids).Methods.A 5-year retrospective review of the M&MC within the Division of Rheumatology at SickKids was completed. Descriptive data including the number and types of events reported were collected. Events were categorized using an adaptation of the National Coordinating Council for Medication Error Reporting and Prevention Index. Recommendations were classified according to the Institute for Safe Medication Practices Canada.Results.Between January 2007 and December 2011, 30 regularly scheduled M&MC were held. Eighty-three cases were reviewed. The most common types of reported events were related to “miscommunication” (34.9%), “treatment/test/procedure” (22.9%), “adverse drug reactions” (12.0%), and “medication errors” (8.4%). Category A events (“an event that has the capacity to cause error”) were the most common with 39.8% of the cases, followed by Category C events (“an event occurred that reached the patient, but did not cause harm”) with 28.9%. Eighty-nine recommendations were made. Over half of these were classified as “information” (58.4%), followed by 11 “rules and policies” recommendations (12.4%). Of the 36 action items generated from these recommendations, most are either complete or ongoing.Conclusion.The M&MC within the Division of Rheumatology reviews a variety of events. Increased reporting of adverse events can lead to system improvements, and has the potential to improve and promote safer healthcare.


Author(s):  
Parastou Fatemi ◽  
Yi Zhang ◽  
Summer S. Han ◽  
Natasha Purington ◽  
Corinna C. Zygourakis ◽  
...  

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1846-1860
Author(s):  
Tahmina A ◽  
Kevin F ◽  
Das S ◽  
Habib N ◽  
Rashid M

COVID -19 pandemic is creating an uncertainty about the demographic trends of morbidity and mortality rates across countries worldwide. Hence, this study is aimed to characterize the gender and age distribution of morbidity and mortality from COVID-19 across populations. This cross-sectional study uses aggregate data on COVID-19 cases and deaths by gender and age. Considering gender-based morbidity, men diagnosed with COVID-19 substantially outnumber infected women with statistically significant findings (*p=<0.05, □ RR>2) in Asian, American, and African countries, whereas women diagnosed higher morbidity rate in European countries. However, gender-based fatality showed higher among men in most of the analyzed countries of all those continents except Australia where female fatality was higher. This study revealed 50 years old were mostly associated with the infection and death in all continents except Australia, showing more morbidity above 20 years of age, whereas, fatality rate was more in the above 80 years group. The study concludes that, across countries, COVID-19 morbidity and fatality rate is age specific rather than gender specific. Infection rates showed rising steeply with age; nevertheless, children do not stand on equal footing when COVID-19 crisis is transforming their day-to-day lives.


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