Safety of jidabokuippo administration based on adverse event rate

Author(s):  
Toshiharu Kitamura ◽  
Hajime Nakae ◽  
Yasuhito Irie ◽  
Kasumi Satoh ◽  
Nobuhisa Hirasawa ◽  
...  
2011 ◽  
Vol 39 (6) ◽  
pp. 932-938 ◽  
Author(s):  
Martin Majlund Mikkelsen ◽  
Niels Holmark Andersen ◽  
Thomas Decker Christensen ◽  
Troels Krarup Hansen ◽  
Hans Eiskjaer ◽  
...  

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Adam L. Sharp ◽  
Aileen Baecker ◽  
Najlla Nassery ◽  
Stacy Park ◽  
Ahmed Hassoon ◽  
...  

AbstractObjectivesDiagnostic error is a serious public health problem. Measuring diagnostic performance remains elusive. We sought to measure misdiagnosis-related harms following missed acute myocardial infarctions (AMI) in the emergency department (ED) using the symptom-disease pair analysis of diagnostic error (SPADE) method.MethodsRetrospective administrative data analysis (2009–2017) from a single, integrated health system using International Classification of Diseases (ICD) coded discharge diagnoses. We looked back 30 days from AMI hospitalizations for antecedent ED treat-and-release visits to identify symptoms linked to probable missed AMI (observed > expected). We then looked forward from these ED discharge diagnoses to identify symptom-disease pair misdiagnosis-related harms (AMI hospitalizations within 30-days, representing diagnostic adverse events).ResultsA total of 44,473 AMI hospitalizations were associated with 2,874 treat-and-release ED visits in the prior 30 days. The top plausibly-related ED discharge diagnoses were “chest pain” and “dyspnea” with excess treat-and-release visit rates of 9.8% (95% CI 8.5–11.2%) and 3.4% (95% CI 2.7–4.2%), respectively. These represented 574 probable missed AMIs resulting in hospitalization (adverse event rate per AMI 1.3%, 95% CI 1.2–1.4%). Looking forward, 325,088 chest pain or dyspnea ED discharges were followed by 508 AMI hospitalizations (adverse event rate per symptom discharge 0.2%, 95% CI 0.1–0.2%).ConclusionsThe SPADE method precisely quantifies misdiagnosis-related harms from missed AMIs using administrative data. This approach could facilitate future assessment of diagnostic performance across health systems. These results correspond to ∼10,000 potentially-preventable harms annually in the US. However, relatively low error and adverse event rates may pose challenges to reducing harms for this ED symptom-disease pair.


2018 ◽  
Vol 34 (12) ◽  
pp. 862-865 ◽  
Author(s):  
David Jones ◽  
Matt Hansen ◽  
Josh Van Otterloo ◽  
Caitlin Dickinson ◽  
Jeanne-Marie Guise

Endoscopy ◽  
2020 ◽  
Vol 53 (01) ◽  
pp. 44-52 ◽  
Author(s):  
Bojan Kovacevic ◽  
Pia Klausen ◽  
Charlotte Vestrup Rift ◽  
Anders Toxværd ◽  
Hanne Grossjohann ◽  
...  

Abstract Background The limited data on the utility of endoscopic ultrasound (EUS)-guided through-the-needle biopsies (TTNBs) in patients with pancreatic cystic lesions (PCLs) originate mainly from retrospective studies. Our aim was to determine the clinical impact of TTNBs, their added diagnostic value, and the adverse event rate in a prospective setting. Methods This was a prospective, single-center, open-label controlled study. Between February 2018 and August 2019, consecutive patients presenting with a PCL of 15 mm or more and referred for EUS were included. Primary outcome was a change in clinical management of PCLs following TTNB compared with cross-sectional imaging and cytology. Adverse events were defined according to the ASGE lexicon. Results 101 patients were included. TTNBs led to a change in clinical management in 11.9 % of cases (n = 12). Of these, 10 had serous cysts and surveillance was discontinued, while one of the remaining two cases underwent surgery following diagnosis of a mucinous cystic neoplasm. The diagnostic yield of TTNBs for a specific cyst diagnosis was higher compared with FNA cytology (69.3 % vs. 20.8 %, respectively; P < 0.001). The adverse event rate was 9.9 % (n = 10; 95 % confidence interval 5.4 % – 17.3 %), with the most common event being acute pancreatitis (n = 9). Four of the observed adverse events were severe, including one fatal outcome. Conclusions TTNBs resulted in a change of clinical management in about one in every 10 patients; however, the associated adverse event risk was substantial. Further studies are warranted to elucidate in which subgroups of patients the clinical benefit outweighs the risks.


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