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 follow up of intractable chronic short lasting unilateral neuralgiform headache disorders treated with occipital nerve stimulation

Cephalalgia ◽  
2017 ◽  
Vol 38 (5) ◽  
pp. 933-942 ◽  
Author(s):  
Sarah Miller ◽  
Laurence Watkins ◽  
Manjit Matharu
Keyword(s):  
Adverse Event ◽  
Nerve Stimulation ◽  
Rating Scale ◽  
Adverse Event Rate ◽  
Occipital Nerve Stimulation ◽  
Attack Frequency ◽  
Occipital Nerve ◽  
Change In Mean

Background Occipital nerve stimulation is a potential treatment option for medically intractable short-lasting unilateral neuralgiform headache attacks. We present long-term outcomes in 31 patients with short-lasting unilateral neuralgiform headache attacks treated with occipital nerve stimulation in an uncontrolled open-label prospective study. Methods Thirty-one patients with intractable short-lasting unilateral neuralgiform headache attacks were treated with bilateral occipital nerve stimulation from 2007 to 2015. Data on attack characteristics, quality of life, disability and adverse events were collected. Primary endpoint was change in mean daily attack frequency at final follow-up. Results At a mean follow-up of 44.9 months (range 13–89) there was a 69% improvement in attack frequency with a response rate (defined as at least a 50% improvement in daily attack frequency) of 77%. Attack severity reduced by 4.7 points on the verbal rating scale and attack duration by a mean of 64%. Improvements were seen in headache-related disability and depression. Adverse event rates were favorable, with no electrode migration or erosion reported. Conclusion Occipital nerve stimulation appears to offer a safe and efficacious treatment for refractory short-lasting unilateral neuralgiform headache attacks with significant improvements sustained in the long term. The procedure has a low adverse event rate when conducted in highly specialised units.

scholarly journals The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

2021 ◽  
pp. bmjqs-2020-011122 ◽  
Author(s):  
Warren Connolly ◽  
Natasha Rafter ◽  
Ronan M Conroy ◽  
Cornelia Stuart ◽  
Anne Hickey ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Positive Impact ◽  
Retrospective Chart Review ◽  
Published Data ◽  
National Programmes ◽  
Event Rates ◽  
Hospital Associated Infections ◽  
Design And Methods ◽  
The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

scholarly journals The efficacy of remdesivir in coronavirus disease 2019 (COVID-19): a systematic review

2020 ◽  
Author(s):  
Amirhossein Roshanshad ◽  
Alireza Kamalipour ◽  
Mohammad Ali Ashraf ◽  
Romina Roshanshad ◽  
Sirous Jafari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Cohort Studies ◽  
Clinical Improvement ◽  
Day Treatment ◽  
Mortality Rates ◽  
Severe Adverse Event ◽  
Adverse Event Rate ◽  
Significant Difference ◽  
Event Rates

Background and Objectives: Researchers all around the world are working hard to find an effective treatment for the new coronavirus 2019. We performed a comprehensive systematic review to investigate the latest clinical evidence on the efficacy and safety of treatment with Remdesivir in hospitalized patients with COVID-19. Materials and Methods: We performed a systematic search in Pubmed, Embase, Web of Science, Google scholar and MedRxiv for relevant observational and interventional studies. The outcomes measures were mortality rates, improvement rates, time to clinical improvement, all adverse event rates and severe adverse event rates. Results: Three randomized controlled trials and 2 cohort studies were included in our study. In the 2 cohort studies, patients received Remdesivir for 10 days. 2 RCTs evaluated 10-day efficacy of treatment with Remdesivir versus placebo group and the other RCT compared its 5-day regimen versus 10-day regimen. Visual inspection of the forest plots revealed that the efficacy of Remdesivir was not much different in reducing 28-day mortality versus 14-day mortality rates. Besides, 10-day treatment regimen overpowered 5-day treatment and placebo in decreasing time to clinical improvement. All adverse event rates did not have a significant difference; however, severe adverse event rate was lower in the 5-day Remdesivir group compared to the 10-day and placebo groups. Conclusion: 5-day course of Remdesivir therapy in COVID-19 patients is probably efficacious and safe, and patients without invasive mechanical ventilation benefit the most. Treatment can be extended to 10 days if satisfactory improvement is not seen by day 5. Most benefits from Remdesivir therapy take place in the first 14 days of the start of the treatment.

Comparing Demographic Characteristics and Adverse Event Rates at Two Dermatologic Surgery Practices

2014 ◽  
Vol 18 (5) ◽  
pp. 337-340 ◽  
Author(s):  
Jenna L. O'Neill ◽  
Brandon Shutty ◽  
Yun Sun Lee ◽  
James A. Solomon ◽  
Nikita Patel ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Geographic Location ◽  
Common Adverse Event ◽  
Adverse Event Rate ◽  
Dermatologic Surgery ◽  
Patient Demographics ◽  
Logistic Regression Procedure ◽  
Event Rates ◽  
Procedure Type

Background: Patient demographics and operative techniques may contribute to adverse events after surgeries. Objective: To identify differences in adverse event rates between different dermatologic surgery centers and potential contributing features affecting these rates. Methods: Data regarding demographics, procedure type, and adverse events were collected at two dermatologic surgery centers. Results: The most common adverse event at both sites was infection: 2.1% at site 1 versus 0.5% at site 2 ( p < .001). Using multivariate logistic regression, procedure type (Mohs surgery), geographic location (being at site 1), older age, and anatomic location of surgery were associated with a higher risk of infection. Conclusion: Adverse event rate appears to correlate with patient demographics, procedure type, and setting of surgery more than use of prophylactic antibiotics. Identification of differences in adverse event rates and potential contributing variables at different practices may allow for identification of opportunities to prevent adverse events.

scholarly journals Remdesivir Efficacy in Coronavirus Disease 2019 (COVID-19): A Systematic Review

2020 ◽  
Author(s):  
Amirhossein Roshanshad ◽  
Alireza Kamalipour ◽  
Mohammad Ali Ashraf ◽  
Romina Roshanshad ◽  
Mohammad Reza Akbari
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Clinical Improvement ◽  
Day Treatment ◽  
Invasive Mechanical Ventilation ◽  
Mortality Rates ◽  
Severe Adverse Event ◽  
Adverse Event Rate ◽  
Significant Difference ◽  
Event Rates

AbstractBackgroundResearchers are working hard to find an effective treatment for the new coronavirus 2019. We performed a comprehensive systematic review to investigate the latest clinical evidence on the treatment efficacy and safety of Remdesivir in hospitalized patients with COVID-19.MethodsWe performed a systematic search of the Pubmed, Embase, Web of Science, Google scholar, and MedRxiv for relevant observational and interventional studies. Measured outcomes were mortality rates, improvement rates, time to clinical improvement, all adverse event rates and severe adverse event rates.Results3 RCTs and 2 cohorts were included in our study. In 2 cohort studies, patients received Remdesivir for 10 days. 2 RCTs evaluated 10-day treatment of Remdesivir efficacy versus placebo group and the other RCT compared its 5-day regimen versus 10-day regimen. Visual inspection of the forest plots revealed that Remdesivir efficacy was not much different in reducing 28-day mortality versus 14-day mortality rates. Besides, 10-day treatment regimen overpowers 5-day treatment and placebo in decreasing time to clinical improvement. All adverse event rates did not have significant difference; however, severe adverse event rate was lower in 5-day Remdesivir group compared to 10-day and placebo groups.Conclusion5-day course of Remdesivir therapy in COVID-19 patients is probably efficacious and safe and patients without invasive mechanical ventilation benefit the most. Treatment can be extended to 10 days if satisfactory improvement is not seen by day 5. Most benefits from Remdesivir therapy take place in the first 14 days of the start of the treatment.

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.

scholarly journals Percutaneous cholecystostomy for biliary decompression in patients with cholangitis and pancreatitis

2018 ◽  
Vol 46 (10) ◽  
pp. 4120-4128 ◽  
Author(s):  
Jin Myung Park ◽  
Chang Don Kang ◽  
Minjong Lee ◽  
Sung Chul Park ◽  
Sung Joon Lee ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Biliary Obstruction ◽  
Clinical Success ◽  
Adverse Event Rate ◽  
Serum Total Bilirubin ◽  
Percutaneous Cholecystostomy ◽  
Success Rates ◽  
Biliary Decompression ◽  
Significant Difference

Objective This study was performed to assess the effectiveness and safety of percutaneous cholecystostomy (PC) for biliary decompression. Methods We retrospectively analyzed our institution’s PC database from March 2015 to August 2017 and selected patients with biliary obstruction. The primary outcomes were the technical and clinical success rates. As secondary outcomes, adverse events and pain after PC were compared with those of patients who underwent PC for acute cholecystitis during the same period. Results Twenty patients underwent PC for biliary obstruction (cholangitis, 19; pancreatitis, 1). The technical and clinical success rates were 100%. The median serum total bilirubin level decreased considerably from 4.5 to 1.4 mg/dL after PC. An adverse event (catheter migration) occurred in 1 patient, and 17 patients developed pain after PC. During the same period, 104 patients underwent PC for cholecystitis. Adverse events occurred in 7 patients, and 62 developed pain. There was no significant difference in the adverse event rate between the cholangitis/pancreatitis and cholecystitis groups (5.0% vs. 6.7%, respectively), but pain occurred considerably more frequently in the cholangitis/pancreatitis group (94.4% vs. 63.9%, respectively). Conclusions PC is an effective and safe method for biliary decompression in selected patients. However, attention should be paid to postoperative pain.

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.

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