Patterns of cutaneous immune‐related adverse events in adults and children with advanced sarcoma: a retrospective cohort study

Author(s):  
L.L. Thompson ◽  
M.S. Chang ◽  
L. McCormack ◽  
N. Polyakov ◽  
J. Yoon ◽  
...  
2010 ◽  
Vol 22 (5) ◽  
pp. 380-385 ◽  
Author(s):  
Mondher Letaief ◽  
Sana El Mhamdi ◽  
Riham El-Asady ◽  
Sameen Siddiqi ◽  
Ahmed Abdullatif

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016546 ◽  
Author(s):  
Jesus Maria Aranaz Andrés ◽  
Ramon Limón Ramírez ◽  
Carlos Aibar Remón ◽  
Maria Teresa Gea-Velázquez de Castro ◽  
Francisco Bolúmar ◽  
...  

BackgroundAdverse events (AEs) epidemiology is the first step to improve practice in the healthcare system. Usually, the preferred method used to estimate the magnitude of the problem is the retrospective cohort study design, with retrospective reviews of the medical records. However this data collection involves a sophisticated sampling plan, and a process of intensive review of sometimes very heavy and complex medical records. Cross-sectional survey is also a valid and feasible methodology to study AEs.ObjectivesThe aim of this study is to compare AEs detection using two different methodologies: cross-sectional versus retrospective cohort design.SettingSecondary and tertiary hospitals in five countries: Argentina, Colombia, Costa Rica, Mexico and Peru.ParticipantsThe IBEAS Study is a cross-sectional survey with a sample size of 11 379 patients. The retrospective cohort study was obtained from a 10% random sample proportional to hospital size from the entire IBEAS Study population.MethodsThis study compares the 1-day prevalence of the AEs obtained in the IBEAS Study with the incidence obtained through the retrospective cohort study.ResultsThe prevalence of patients with AEs was 10.47% (95% CI 9.90 to 11.03) (1191/11 379), while the cumulative incidence of the retrospective cohort study was 19.76% (95% CI 17.35% to 22.17%) (215/1088). In both studies the highest risk of suffering AEs was seen in Intensive Care Unit (ICU) patients. Comorbid patients and patients with medical devices showed higher risk.ConclusionThe retrospective cohort design, although requires more resources, allows to detect more AEs than the cross-sectional design.


Author(s):  
Anna Condella ◽  
Jeremy B. Richards ◽  
Michael A. Frakes ◽  
Christian J. Grant ◽  
Jason E. Cohen ◽  
...  

Abstract Background: Extracorporeal membrane oxygenation (ECMO) has accelerated rapidly for patients in severe cardiac or respiratory failure. As a result, ECMO networks are being developed across the world using a “hub and spoke” model. Current guidelines call for all patients transported on ECMO to be accompanied by a physician during transport. However, as ECMO centers and networks grow, the increasing number of transports will be limited by this mandate. Objectives: The aim of this study was to compare rates of adverse events occurring during transport of ECMO patients with and without an additional clinician, defined as a physician, nurse practitioner (NP), or physician assistant (PA). Methods: This is a retrospective cohort study of all adults transported while cannulated on ECMO from 2011-2018 via ground and air between 21 hospitals in the northeastern United States, comparing transports with and without additional clinicians. The primary outcome was the rate of major adverse events, and the secondary outcome was minor adverse events. Results: Over the seven-year study period, 93 patients on ECMO were transported. Twenty-three transports (24.7%) were accompanied by a physician or other additional clinician. Major adverse events occurred in 21.5% of all transports. There was no difference in the total rate of major adverse events between accompanied and unaccompanied transports (P = .91). Multivariate analysis did not demonstrate any parameter as being predictive of major adverse events. Conclusions: In a retrospective cohort study of transports of ECMO patients, there was no association between the overall rate of major adverse events in transport and the accompaniment of an additional clinician. No variables were associated with major adverse events in either cohort.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 684-684
Author(s):  
Hiraku Fukushima ◽  
Satoshi Yuki ◽  
Yoshimitsu Kobayashi ◽  
Kazuteru Hatanaka ◽  
Takaya Kusumi ◽  
...  

684 Background: Bevacizumab (BV) is widely used in first-line chemotherapy for metastatic colorectal cancer in Japan, but the use of beyond bevacizumab first progression (BBP) has been controversial yet. Methods: Of patients treated with first-line BV in our retrospective cohort study (HGCSG0801), patients treated with BBP (n=22) and those without BBP ( n=19) in second-line setting were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to assess adverse events. The Response Evaluation in Solid Tumors (RECIST) criteria version 1.0 was used to assess tumor response. The Kaplan–Meier method was used to determine PFS and OS. Log-rank test was used to compare each group in terms of PFS and OS. All statistical tests were performed using SPSS. Results: PS (0/1/2) before second line chemotherapy was 18/3/1 in BBP and 10/8/1 in NBBP, respectively. In the safety analysis, five patients in BBP showed a worsening/newer hypertension, which wasn’t a clinical problem. In the efficacy analysis, the response rate was 22.8% in BBP and 0% in NBBP. The median PFS was better in BBP (6.7 months in BBP and 2.7 months in NBBP), but there was no significant difference in median OS from first BV administration between two groups (27.3 months in BBP and 22.2 months in NBBP). Conclusions: We analyzed BBP in daily practice in Japan. Adverse events were well tolerated, but survival advantage of BBP was not suggested. About the efficacy of BBP, we are waiting the results of ongoing Phase III trials.


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