The Safety of Acupuncture – Evidence from the Uk

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 53-57 ◽  
Author(s):  
Adrian White
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Serious Adverse Events ◽  
Positive Evidence ◽  
Safe Treatment ◽  
Significant Events ◽  
The Uk

Background Patients are attracted to acupuncture partly by its reputation for having low risks. The safety of acupuncture should be established by positive evidence. Methods Two prospective surveys were conducted among different groups of professionals in the UK, including doctors, physiotherapists and practitioners primarily trained in acupuncture. Participants monitored adverse events over a defined period of time, and reported minor and significant events on purpose designed forms. Results A total of 652 acupuncturists reported 6733 adverse reactions including tiredness in 66 229 patients, an adverse event rate of 10.2%. The most common events were tiredness (3%) bleeding or bruising (3%), aggravation of symptoms (2%) and pain at the needling site (1%). There were no serious adverse events. A total of 86 (0.1%) of the treatments was associated with an event that the practitioner judged to be significant though without persistent consequences for the patient's health. Conclusion The risks associated with acupuncture can be classified as negligible, and acupuncture is a very safe treatment in the hands of competent practitioners.

Clinical impact of endoscopic ultrasound-guided through-the-needle microbiopsy in patients with pancreatic cysts

Endoscopy ◽  
2020 ◽  
Vol 53 (01) ◽  
pp. 44-52 ◽  
Author(s):  
Bojan Kovacevic ◽  
Pia Klausen ◽  
Charlotte Vestrup Rift ◽  
Anders Toxværd ◽  
Hanne Grossjohann ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Endoscopic Ultrasound ◽  
Clinical Management ◽  
Event Rate ◽  
Clinical Impact ◽  
Adverse Event Rate ◽  
Controlled Study ◽  
Cystic Neoplasm ◽  
Pancreatic Cysts

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.

scholarly journals Stent Applications for Palliative Treatment in Advanced Stage Esophageal Cancers

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Mustafa Şentürk ◽  
Murat Çakır ◽  
Mehmet Aykut Yıldırım ◽  
Ömer Kişi
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Palliative Treatment ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Endoscopic Stenting ◽  
Covered Stents ◽  
Advanced Stage ◽  
Esophageal Cancers ◽  
Uncovered Stents

Background and Aim. Endoscopic stenting is a generally safe and effective palliative treatment for esophageal malignancies. In this study, we aimed to present endoscopic stent applications, adverse events, and relative advantages of covered versus uncovered stents in our center. Methods. We examined cases of endoscopic stenting for palliative treatment of advanced stage esophageal cancers between January 2014 and July 2019. Age, gender, location of mass, adverse events, survival time, and stent type were evaluated. Outcomes of fully covered and uncovered self-expanding stents were compared with regard to adverse events, including stent migration and occlusion. Results. The mean age of the patients was 66.4 ± 1 , 52 were male, and 8 were female. Patients were followed up for a mean of 133 days. The most common complication due to stenting was migration. 13 patients developed adverse events. Migration was the most common adverse event, occurring in 8 (13%) patients. Although the migration rate of fully covered stents was higher than uncovered stents, there was no statistically significant difference ( p = 0.47 ). Stent occlusion was observed in 4 patients. In three cases, it was due to the tumor; an uncovered stent was placed again in these cases. Food-related occlusion developed in one patient. There was no statistical difference in terms of overall adverse event rate when comparing fully covered stents to uncovered stents ( p = 0.68 ). Conclusion. Endoscopic stenting is a viable palliative method with low morbidity and mortality in experienced centers. Though there are relative advantages with covered versus uncovered stents in individual cases, the overall adverse event rate is low and relatively similar.

scholarly journals Outcomes of Non-anesthesiologist-Administered Propofol in Pediatric Gastroenterology Procedures

2021 ◽  
Vol 8 ◽  
Author(s):  
Frances C. Lee ◽  
Karen Queliza ◽  
Bruno P. Chumpitazi ◽  
Amber P. Rogers ◽  
Catherine Seipel ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
General Anesthesia ◽  
Safety Profile ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Gastrointestinal Adverse Event ◽  
Acceptable Safety Profile ◽  
Physical Classification ◽  
American Society

Background and Aims: Non-anesthesiologist-administered propofol (NAAP) has been found to have an acceptable safety profile in adult endoscopy, but its use remains controversial and pediatric data is limited. Our aim was to examine the safety and efficacy of NAAP provided by pediatric hospitalists in pediatric endoscopy.Methods: We retrospectively reviewed 929 esophagogastroduodenoscopy (EGD), colonoscopy, and combined EGD/colonoscopy cases in children aged 5–20 years between April 2015 and December 2016 at a large children's hospital. We analyzed the data for adverse events in relation to demographics and anthropometrics, American Society of Anesthesiologists physical classification score, presence of a trainee, comorbid conditions, and procedure time.Results: A total of 929 cases were included of which 496 (53%) were completed with NAAP. Seventeen (3.4%) of NAAP cases had an adverse event including the following: 12 cases of hypoxia, 2 cardiac, and 3 gastrointestinal adverse events. General anesthesia cases had 62 (14.3%) adverse events including the following: 54 cases of hypoxia, 1 cardiac, 7 gastrointestinal, and 1 urologic adverse event. No adverse events in either group required major resuscitation. NAAP vs. general anesthesia had a lower overall adverse event rate (3.4 vs. 14.3%, p &lt; 0.0004) and respiratory adverse event rate (2.4% vs. 12.5%, p &lt; 0.0004). Overall, cardiac and gastrointestinal adverse event rates between the two groups were comparable. When accounting for all captured factors via logistic regression, both younger age (P &lt; 0.001) and general anesthesia (P &lt; 0.0001) remained risk factors for an adverse event.Conclusion: The overall adverse event rate of NAAP was low (3.4%) with none requiring major resuscitation or hospitalization. This is comparable to studies of NAAP in adult endoscopy and suggests that NAAP provided by pediatric hospitalists has an acceptable safety profile.

TM2-2 Analysis of adverse events in the management of chronic headache by occipital nerve stimulation

2019 ◽  
Vol 90 (3) ◽  
pp. e13.2-e13
Author(s):  
S Miller ◽  
L Watkins ◽  
M Matharu
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Nerve Stimulation ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Occipital Nerve Stimulation ◽  
Occipital Nerve ◽  
Significant Difference ◽  
Event Rates ◽  
The Impact

ObjectivesTo analyse long-term adverse events of occipital nerve stimulation (ONS).DesignProspective open-label observational study.Subjects134 patients with refractory headaches implanted between 2007–2014 in a single specialised centre.MethodsInformation was collected on ONS device, implantable pulse generator (IPG) site and adverse event rates. The impact of implanter experience and the association between IPG site and adverse event rates was also explored.ResultsMean follow up was 46 months (6–108 months). A total of 139 adverse events were recorded in 75 patients (56%). A total of 59 additional surgeries were needed in 39 patients. A significant difference was seen in the rates of adverse events recorded between 2007–2010 and 2011–2014 (60.7% vs 42.6%, p=0.002). A significant reduction in ONS revision was seen over time (25.7% vs 5.9%, p=0.002). Analysis of adverse events with IPG site showed those with abdominal implants recorded higher adverse event rate that those with an IPG in the chest (65.8% vs 40.3%, p=0.004).ConclusionsIn specialist centres, adverse event rates of ONS can be much lower than reported in the literature. Our results suggest implanter experience and IPG site both have an effect on adverse event rate.

scholarly journals Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

2020 ◽  
Author(s):  
Rainer Kozlik-Feldmann ◽  
Avraham Lorber ◽  
Horst Sievert ◽  
Peter Ewert ◽  
Christian Jux ◽  
...  
Keyword(s):  
Adverse Event ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Ventricular Septal Defects ◽  
Serious Adverse Events ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Septal Defects ◽  
Device Implantation ◽  
Study Results

Abstract Objective This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. Background The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. Methods In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. Results The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2–65) years and a median body weight of 26.7 (10–109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). Conclusion The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.

scholarly journals Impact of physiologically shaped pancreatic stent for chronic pancreatitis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yasuki Hori ◽  
Yuka Ichino ◽  
Itaru Naitoh ◽  
Kazuki Hayashi ◽  
Michihiro Yoshida ◽  
...  
Keyword(s):  
Adverse Event ◽  
Chronic Pancreatitis ◽  
Adverse Events ◽  
Event Rate ◽  
Medical Costs ◽  
Adverse Event Rate ◽  
Pancreatic Stent ◽  
Stent Patency ◽  
Related Adverse Event ◽  
Pancreatic Duct Obstruction

AbstractEndoscopic pancreatic stenting is used to prevent main pancreatic duct obstruction and relieve painful symptoms of chronic pancreatitis. However, the stent typically needs to be exchanged and the rate of adverse events is high. Few studies have evaluated the effect of stent shape on those outcomes. We evaluated the adverse events, stent patency, and total medical cost within 90 days of patients who received an 8.5 French (Fr) physiologically shaped pancreatic stent by comparing these features with those associated with a conventional straight-type stent for ≥ 90 days. The total stent-related adverse event rate was significantly lower for the physiologically shaped pancreatic stent (physiologically shaped, 6.7% [2/30]; straight-type, 50.6% [44/87]; P < 0.001). Stent occlusion was significantly less frequent (P < 0.001) and the total medical costs were significantly lower (P = 0.002) for the physiologically shaped stent. The stent-related adverse event rate was significantly higher for the 10 Fr straight type stent than for the 8.5 Fr physiologically shaped stent (10 Fr, straight-type vs. 8.5 Fr, physiologically shaped: 36.1% [13/36] vs. 6.7% [2/30]; P = 0.007). In conclusion, a physiologically shaped pancreatic stent was superior to a straight-type stent in terms of the patency rate and medical costs.

scholarly journals Adverse medication events in a psychiatric practice: a naturalistic study

2013 ◽  
Vol 37 (12) ◽  
pp. 395-397
Author(s):  
Eugene G. Breen
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Drug Events ◽  
Psychiatric Training ◽  
Clinical Implications ◽  
Naturalistic Study ◽  
Near Misses ◽  
Significant Events ◽  
Core Module ◽  
Sector Service

Aims and methodTo document the number and type of adverse medication events in a psychiatric sector service. Significant new adverse events were collated by the author and team over 30 months. Intervention to prevent any adverse event was enacted as soon as any were noticed or anticipated.ResultsThirty-six significant events occurred including three deaths and nine near misses. Corrective action was taken immediately any adverse event occurred. Inadequate communication between various hospital clinics, general practitioner practices, psychiatric clinics and pharmacies was the biggest avoidable cause of adverse events.Clinical implicationsAwareness of adverse drug events is essential in psychiatry. Clear, transparent pathways of prescribing are a key requirement to reduce avoidable adverse medication events. Psychopharmacology is a core module for psychiatric training.

scholarly journals Microalbuminuria is associated with high adverse event rate following cardiac surgery

2011 ◽  
Vol 39 (6) ◽  
pp. 932-938 ◽  
Author(s):  
Martin Majlund Mikkelsen ◽  
Niels Holmark Andersen ◽  
Thomas Decker Christensen ◽  
Troels Krarup Hansen ◽  
Hans Eiskjaer ◽  
...  
Keyword(s):  
Adverse Event ◽  
Cardiac Surgery ◽  
Event Rate ◽  
Adverse Event Rate ◽  
High Adverse Event

Missed acute myocardial infarction in the emergency department–standardizing measurement of misdiagnosis-related harms using the SPADE method

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Adam L. Sharp ◽  
Aileen Baecker ◽  
Najlla Nassery ◽  
Stacy Park ◽  
Ahmed Hassoon ◽  
...  
Keyword(s):  
Emergency Department ◽  
Adverse Event ◽  
Chest Pain ◽  
Administrative Data ◽  
Diagnostic Performance ◽  
Event Rate ◽  
Public Health Problem ◽  
Diagnostic Error ◽  
Adverse Event Rate ◽  
Disease Pair

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.

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