Factors associated with the incidence of serious adverse events in patients admitted with COPD acute exacerbation

2016 ◽  
Vol 186 (2) ◽  
pp. 477-483 ◽  
Author(s):  
M.-T. García-Sanz ◽  
J.-C. Cánive-Gómez ◽  
N. García-Couceiro ◽  
L. Senín-Rial ◽  
S. Alonso-Acuña ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Exacerbation ◽  
Serious Adverse Events ◽  
Factors Associated

scholarly journals Factors associated with mechanical and systemic adverse events after colonoscopy (France, 2010-2015)

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Older Patients ◽  
Public Hospitals ◽  
Serious Adverse Events ◽  
Logistic Regression Models ◽  
Factors Associated ◽  
Increased Risk ◽  
Experienced Endoscopists

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.

scholarly journals Procedural Pain and Serious Adverse Events with Bone Marrow Aspiration and Biopsy: Real World Experience from India

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 38-38
Author(s):  
Chepsy C Philip ◽  
Inderjit Singh ◽  
Rachel Thaper ◽  
Alice David ◽  
Suvir Singh ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Adverse Event ◽  
Adverse Events ◽  
Pain Perception ◽  
Bone Marrow Aspiration ◽  
Procedural Pain ◽  
Routine Practice ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Factors Associated

Background: Bone Marrow aspiration and Biopsy (BMAB) is perceived by patients as a painful procedure with fearsome complications. Though informed as safe and well tolerated; there is limited data about the complications and degree of pain experienced by patients undergoing BMAB.[1] Further scarce is data from the developing world where procedural fear discourages patients from pursuing treatment and diagnosis.[2] Methods Aims: To estimate the level of pain and frequency of serious adverse eventsexperienced by patients undergoing BMAB at our center. We also attempted to identify factors associated with increased pain perception. Study setting: This study was conducted at a tertiary level teaching hospital, the Christian Medical College & Hospital, Ludhiana. Ethics approval was obtained from the Institutional research committee (CMC/1495). Study period: 01 April 2015 through 30 Nov 2019 Study Design: This is a comparative cross sectional study where comparison of those with relatively more pain to those with less was done to elicit the factors associated with pain perception. Study Population: All consecutive patients who underwent a BMAB and provided informed consent which was taken pre-procedure, were included. We excluded patients who underwent the procedure under general anesthesia. Logistics of the Study: The BMAB was performed variably by Consultant Physicians, Trainee Physicians and Physician Assistants. All patients were pre-medicated with tramadol intravenous pre-procedure, and the preferred approach was from the posterior superior iliac spine (PSIS) in a left lateral decubitus under local anesthesia with lignocain. Patients were sent home or returned to their ward after upto 60 minutes of observation. A serious adverse event was considered as one requiring a prolonged observation beyond routine practice or extending to an admission to manage adverse events following and related to the BMAB. Data sources and variables Information regarding age at diagnosis, address and sex, indication to perform the BMAB, coded as malignant and non-malignant was collected from each patient. Number of prior procedures and details regarding food intake were collected as recalled by the patient. Level of pain was noted soon after the BMAB using a combined Wong-Baker grimace with numeric pain scale by the patient themselves. Statistical Analysis: Descriptive statistics were used to characterize variables. Univariate and Multivariate Logistic Regression were used to identify factors associated with higher pain severity (Score >2). Results: A total of 942 BMAB procedures were performed in this period. Baseline characteristics as tabulated below (Table1). Although the Mean + SD pain score was only 2.7 + 1.39, fourteen patients (1.48%) reported severe pain (>8). The following risk-factors were associated with increased pain on multivariate analysis: those experiencing their first BMAB procedure had very low odds of pain (OR (95 % CI): 0.23 (0.15-0.37)). However, when more than one attempt of biopsy was made, the odds of pain was much higher (OR (95 % CI): 1.62 (1.29-2.05)). Food and drink intake prior to procedure was associated only at the univariate level. Those who did not take any food prior to procedure had very high odds of pain (odds ratio (OR) 1.81 (95 % CI 1.01-3.22)). However, those who took juice had very low odds (OR (95 % CI): 0.619 (0.43-0.90)). Nine (0.95%) serious adverse events were reported. There were no deaths. The major serious adverse event was hemorrhage resulting from pseudo-aneurysm of the posterior iliac artery, which comprised 2 of the 9 serious adverse events. Other serious adverse events included persistent vomiting and severe aching pain in the ipsilateral leg. Conclusions: In our analysis BMAB is associated with a low level of procedural pain and is safe. The pain perception was not influenced by the operator. Factors associated with decreased pain perception were first procedural BMAB experience and successful completion of the procedure in the first attempt. Having at least a snack or a juice pre-procedure could reduce pain perception. Serious adverse events are rare in our experience. Disclosures No relevant conflicts of interest to declare.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  
Keyword(s):  
Visual Cortex ◽  
Adverse Events ◽  
Clinical Intervention ◽  
Occipital Cortex ◽  
Neuronal Population ◽  
Serious Adverse Events ◽  
Stimulation Parameters ◽  
The Right ◽  
Visual Cortical ◽  
Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

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