scholarly journals Patterns in neurosurgical adverse events: intracranial neoplasm surgery

2012 ◽  
Vol 33 (5) ◽  
pp. E16 ◽  
Author(s):  
Judith M. Wong ◽  
Jaykar R. Panchmatia ◽  
John E. Ziewacz ◽  
Angela M. Bader ◽  
Ian F. Dunn ◽  
...  

Object Neurosurgery is a high-risk specialty currently undertaking the pursuit of systematic approaches to measuring and improving outcomes. As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in cranial tumor resection concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Methods The authors performed a PubMed search using search terms “intracranial neoplasm,” “cerebral tumor,” “cerebral meningioma,” “glioma,” and “complications” or “adverse events.” Only papers that specifically discussed the relevant complication rates were included. Papers were chosen to maximize the range of rates of occurrence for the reported adverse events. Results Review of the tumor neurosurgery literature showed that documented overall complication rates ranged from 9% to 40%, with overall mortality rates of 1.5%–16%. There was a wide range of types of adverse events overall. Deep venous thromboembolism (DVT) was the most common adverse event, with a reported incidence of 3%–26%. The presence of new or worsened neurological deficit was the second most common adverse event found in this review, with reported rates ranging from 0% for the series of meningioma cases with the lowest reported rate to 20% as the highest reported rate for treatment of eloquent glioma. Benign tumor recurrence was found to be a commonly reported adverse event following surgery for intracranial neoplasms. Rates varied depending on tumor type, tumor location, patient demographics, surgical technique, the surgeon's level of experience, degree of specialization, and changes in technology, but these effects remain unmeasured. The incidence on our review ranged from 2% for convexity meningiomas to 36% for basal meningiomas. Other relatively common complications were dural closure–related complications (1%–24%), postoperative peritumoral edema (2%–10%), early postoperative seizure (1%–12%), medical complications (6%–7%), wound infection (0%–4%), surgery-related hematoma (1%–2%), and wrong-site surgery. Strategies to minimize risk of these events were evaluated. Prophylactic techniques for DVT have been widely demonstrated and confirmed, but adherence remains unstudied. The use of image guidance, intraoperative functional mapping, and real-time intraoperative MRI guidance can allow surgeons to maximize resection while preserving neurological function. Whether the extent of resection significantly correlates with improved overall outcomes remains controversial. Discussion A significant proportion of adverse events in intracranial neoplasm surgery may be avoidable by use of practices to encourage use of standardized protocols for DVT, seizure, and infection prophylaxis; intraoperative navigation among other steps; improved teamwork and communication; and concentrated volume and specialization. Systematic efforts to bundle such strategies may significantly improve patient outcomes.

2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety


2012 ◽  
Vol 33 (5) ◽  
pp. E15 ◽  
Author(s):  
Judith M. Wong ◽  
John E. Ziewacz ◽  
Allen L. Ho ◽  
Jaykar R. Panchmatia ◽  
Albert H. Kim ◽  
...  

Object As part of a project to devise evidence-based safety interventions for specialty surgery, we sought to review current evidence concerning the frequency of adverse events in open cerebrovascular neurosurgery and the state of knowledge regarding methods for their reduction. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Methods The authors performed a PubMed search using search terms “cerebral aneurysm”, “cerebral arteriovenous malformation”, “intracerebral hemorrhage”, “intracranial hemorrhage”, “subarachnoid hemorrhage”, and “complications” or “adverse events.” Only papers that specifically discussed the relevant complication rates were included. Papers were chosen to be included to maximize the range of rates of occurrence for the reported adverse events. Results The review revealed hemorrhage-related hyperglycemia (incidence rates ranging from 27% to 71%) and cerebral salt-wasting syndromes (34%–57%) to be the most common perioperative adverse events related to subarachnoid hemorrhage (SAH). Next in terms of frequency was new cerebral infarction associated with SAH, with a rate estimated at 40%. Many techniques are advocated for use during surgery to minimize risk of this development, including intraoperative neurophysiological monitoring, but are not universally used due to surgeon preference and variable availability of appropriate staffing and equipment. The comparative effectiveness of using or omitting monitoring technologies has not been evaluated. The incidence of perioperative seizure related to vascular neurosurgery is unknown, but reported seizure rates from observational studies range from 4% to 42%. There are no standard guidelines for the use of seizure prophylaxis in these patients, and there remains a need for prospective studies to support such guidelines. Intraoperative rupture occurs at a rate of 7% to 35% and depends on aneurysm location and morphology, history of rupture, surgical technique, and surgeon experience. Preventive strategies include temporary vascular clipping. Technical adverse events directly involving application of the aneurysm clip include incomplete aneurysm obliteration and parent vessel occlusion. The rates of these events range from 5% to 18% for incomplete obliteration and 3% to 12% for major vessel occlusion. Intraoperative angiography is widely used to confirm clip placement; adjuncts include indocyanine green video angiography and microvascular Doppler ultrasonography. Use of these technologies varies by institution. Discussion A significant proportion of these complications may be avoidable through development and testing of standardized protocols to incorporate monitoring technologies and specific technical practices, teamwork and communication, and concentrated volume and specialization. Collaborative monitoring and evaluation of such protocols are likely necessary for the advancement of open cerebrovascular neurosurgical quality.


2014 ◽  
Vol 18 (5) ◽  
pp. 337-340 ◽  
Author(s):  
Jenna L. O'Neill ◽  
Brandon Shutty ◽  
Yun Sun Lee ◽  
James A. Solomon ◽  
Nikita Patel ◽  
...  

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.


Author(s):  
Moonis Mirza ◽  
Farooq A Jan ◽  
Syed Hina Mumtaz ◽  
Fayaz Ahmad Sofi ◽  
Rauf Ahmad Wani

ABSTRACT Background Adverse events in hospitals are now widely agreed to be a serious problem, annually killing more people than breast cancer or AIDS. Aims: To study incidence of adverse events in admitted patients by current record review. Aims To study incidence of adverse events in admitted patients by current record review. Materials and methods A two-staged prospective study for a period of 1 year was carried out. Current records of inpatients were screened for adverse events. The adverse event was categorized as preventable or nonpreventable on the basis of World Health Organization (WHO) set confidence score of preventability. Results A total of 3150 patients were screened, among which 488 (15.5%) patients were screened positive for having adverse event. Readmission during last 12 months to any given healthcare for the same health condition (32.79%) was the most common adverse event seen. Hospital acquired infection/sepsis (26.64%) was the second most common adverse event seen. The 78% of adverse events presented with untoward outcome among which 81.8% of adverse events resulted in admission in wards, 4.33% adverse events were associated with death, 23.4% adverse events were associated with disability at discharge and 35.5% adverse events were associated with prolonged stay. A total of 67.4% of studied adverse events showed signs of healthcare team responsible for causing adverse events, among which 76.8% of adverse events occurred outside SKIMS before the index admission. A total of 71.3% of adverse events were categorized preventable. Conclusion Hospital acquired infection was found responsible for prolonged stay of the patients. Proper referral policy must be followed by the department of health services. How to cite this article Mirza M, Jan FA, Mumtaz SH, Sofi FA, Wani RA. A Study of Patient Safety with Special Reference to Incidence of Adverse Events taking Place in Patients in a Tertiary Care Hospital in North India. Int J Res Foundation Hosp Healthc Adm 2015;3(2):91-97.


Medicina ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 1235
Author(s):  
Ludovico Furlan ◽  
Lucia Trombetta ◽  
Giovanni Casazza ◽  
Franca Dipaola ◽  
Raffaello Furlan ◽  
...  

Background and Objectives: Knowledge of the incidence and time frames of the adverse events of patients presenting syncope at the ED is essential for developing effective management strategies. The aim of the present study was to perform a meta-analysis of the incidence and time frames of adverse events of syncope patients. Materials and Methods: We combined individual patients’ data from prospective observational studies including adult patients who presented syncope at the ED. We assessed the pooled rate of adverse events at 24 h, 72 h, 7–10 days, 1 month and 1 year after ED evaluation. Results: We included nine studies that enrolled 12,269 patients. The mean age varied between 53 and 73 years, with 42% to 57% females. The pooled rate of adverse events was 5.1% (95% CI 3.4% to 7.7%) at 24 h, 7.0% (95% CI 4.9% to 9.9%) at 72 h, 8.4% (95% CI 6.2% to 11.3%) at 7–10 days, 10.3% (95% CI 7.8% to 13.3%) at 1 month and 21.3% (95% CI 15.8% to 28.0%) at 1 year. The pooled death rate was 0.2% (95% CI 0.1% to 0.5%) at 24 h, 0.3% (95% CI 0.1% to 0.7%) at 72 h, 0.5% (95% CI 0.3% to 0.9%) at 7–10 days, 1% (95% CI 0.6% to 1.7%) at 1 month and 5.9% (95% CI 4.5% to 7.7%) at 1 year. The most common adverse event was arrhythmia, for which its rate was 3.1% (95% CI 2.0% to 4.9%) at 24 h, 4.8% (95% CI 3.5% to 6.7%) at 72 h, 5.8% (95% CI 4.2% to 7.9%) at 7–10 days, 6.9% (95% CI 5.3% to 9.1%) at 1 month and 9.9% (95% CI 5.5% to 17) at 1 year. Ventricular arrhythmia was rare. Conclusions: The risk of death or life-threatening adverse event is rare in patients presenting syncope at the ED. The most common adverse events are brady and supraventricular arrhythmias, which occur during the first 3 days. Prolonged ECG monitoring in the ED in a short stay unit with ECG monitoring facilities may, therefore, be beneficial.


2021 ◽  
pp. 105566562110378
Author(s):  
Kevin J. Carlson ◽  
Suhas R. Bharadwaj ◽  
William M. Dougherty ◽  
Eric J. Dobratz

Objective This study aims to assess early adverse events and patient factors associated with complications following mandible distraction osteogenesis (MDO). Materials and Methods The American College of Surgeons National Surgical Quality Improvement Program-Pediatric (NSQIP-Pediatric) database, years 2012 to 2019, was queried for patients undergoing mandible advancement via relevant Current Procedural Terminology and postoperative diagnosis codes. Thirty-day adverse events and co-morbidities are assessed. Results A total of 208 patients were identified with 17.3% (n = 36) experiencing an adverse event, reoperation (n = 14), and readmission (n = 11) being most common. Patients < 365 days old at the time of operation were more likely to experience an adverse event (26.1% vs 10.8%; P = .005). However, among patients less than 1 year of age, differences in the complication rates between patients  ≤ 28 days and >28 days (30.2% vs 22.2%; P = .47) and those weighing  ≤ 4 kg and >4 kg (31.7% vs 11.5%; P = .063) did not reach statistical significance. Conclusions Adverse events following mandible advancement are relatively common, though often minor. In our analysis of the NSQIP-Pediatric database, neonatal age ( ≤ 28 days) or weight  ≤ 4 kg did not result in a statistically significant increase in complications among patients less than 1 year of age. Providers should consider early intervention in patients who may benefit from MDO.


Immunotherapy ◽  
2021 ◽  
Author(s):  
Omar Abdel-Rahman

Objective: To analyze tumor- and treatment-related factors that might impact the development of certain adverse events (AEs) of potential immune etiology among patients receiving PD-(L)1 inhibitors. Methods: The FDA Adverse Event Reporting System (FAERS) was accessed, and AE reports related to the use of PD-L1 inhibitors were reviewed. Associations between treatment, tumor type and occurrence of AEs of special interest were analyzed through multivariable logistic regression analysis. Results: A total of 80,304 AE reports were included in the current analysis. Diagnosis with lung cancer was associated with a higher probability of pneumonitis; diagnosis with melanoma was associated with a higher probability of hepatitis, hypophysitis/hypopituitarism and uveitis; and diagnosis with genitourinary cancers was associated with a higher probability of nephritis, adrenal insufficiency and myocarditis. Conclusion:  Within this cohort limited to AEs reported to the FAERS, there is an association between different AEs of special interest, agent(s) used and tumor(s) treated.


2015 ◽  
Vol 6 (2) ◽  
pp. 14-18 ◽  
Author(s):  
D. H. Kim ◽  
A. Kinmond ◽  
S. Gilani ◽  
S. Giridharan ◽  
A. Jegannathen

AbstractINTRODUCTION: The aim of this study is to assess the efficacy and toxicity of maintenance pemetrexed following induction treatment with cisplatin and pemetrexed for patients with advanced non-small cell lung cancer.PATIENTS AND METHODS: Eligible patients following four cycles of intravenous pemetrexed (Alimpta©; 500 mg/m2) and intravenous cisplatin (75 mg/m2) were given 21-day cycles of maintenance pemetrexed (500 mg/m2) until disease progression, unacceptable adverse event or death. From a total 80 patients receiving palliative induction chemotherapy, 17 subsequently received maintenance pemetrexed.RESULTS: The mean number of maintenance cycles completed was 5.9 (range 1-20; median 3.0). The mean progression-free survival (PFS) was 5.2 months (range: 2-15; median: 2.0) and the 1-year PFS was 17%. Treatment was discontinued due to disease progression (71%), adverse event (21%) and death from study disease (7%). Grade 3-4 laboratory and non-laboratory adverse events were seen in 11.8 and 17.6% of patients, respectively. Anaemia was the most common adverse event (71% of all patients; 65% grade 1-2; 5.9% grade 3-4). The most common reason for withdrawal due to adverse event was declining renal function. There was a statistically significant correlation between worsening performance status and reducing number of maintenance cycles completed (Spearman’s rank; R = −0.511, p = 0.036).DISCUSSION: The median PFS was lower than in previous studies with a higher than previously reported frequency of adverse events. Clinicians must monitor renal function and full blood counts vigilantly, especially in patients with performance status greater than 0.


2012 ◽  
Vol 33 (5) ◽  
pp. E13 ◽  
Author(s):  
Judith M. Wong ◽  
John E. Ziewacz ◽  
Allen L. Ho ◽  
Jaykar R. Panchmatia ◽  
Angela M. Bader ◽  
...  

Object As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in CSF shunt surgery concerning the frequency of adverse events in practice, their patterns, and the state of knowledge regarding methods for their reduction. This review may also inform future and ongoing efforts for the advancement of neurosurgical quality. Methods The authors performed a PubMed search using search terms “cerebral shunt,” “cerebrospinal fluid shunt,” “CSF shunt,” “ventriculoperitoneal shunt,” “cerebral shunt AND complications,” “cerebrospinal fluid shunt AND complications,” “CSF shunt AND complications,” and “ventriculoperitoneal shunt AND complications.” Only papers that specifically discussed the relevant complication rates were included. Papers were chosen to be included to maximize the range of rates of occurrence for the adverse events reported. Results In this review of the neurosurgery literature, the reported rate of mechanical malfunction ranged from 8% to 64%. The use of programmable valves has increased but remains of unproven benefit even in randomized trials. Infection was the second most common complication, with the rate ranging from 3% to 12% of shunt operations. A meta-analysis that included 17 randomized controlled trials of perioperative antibiotic prophylaxis demonstrated a decrease in shunt infection by half (OR 0.51, 95% CI 0.36–0.73). Similarly, use of detailed protocols including perioperative antibiotics, skin preparation, and limitation of OR personnel and operative time, among other steps, were shown in uncontrolled studies to decrease shunt infection by more than half. Other adverse events included intraabdominal complications, with a reported incidence of 1% to 24%, intracerebral hemorrhage, reported to occur in 4% of cases, and perioperative epilepsy, with a reported association with shunt procedures ranging from 20% to 32%. Potential management strategies are reported but are largely without formal evaluation. Conclusions Surgery for CSF shunt placement or revision is associated with a high complication risk due primarily to mechanical issues and infection. Concerted efforts aimed at large-scale monitoring of neurosurgical complications and consistent quality improvement within these highlighted realms may significantly improve patient outcomes.


2020 ◽  
pp. 194589242097046
Author(s):  
Khodayar Goshtasbi ◽  
Jack L. Birkenbeuel ◽  
Mehdi Abouzari ◽  
Brandon M. Lehrich ◽  
Tyler M. Yasaka ◽  
...  

Introduction The short-term adverse events and predictors of morbidity in surgical resection of esthesioneuroblastoma (ENB) are largely unknown, and investigating these variables can help direct planning for at-risk patients. Methods The 2005–2017 National Surgical Quality Improvement Program database was queried to identify patients with a diagnosis of ENB undergoing skull base surgery for tumor resection. Information regarding demographics, patient morbidity score, pre-operative and intra-operative data, and post-operative outcomes were extracted. Cox proportional hazard analysis was utilized to assess complication and readmission/reoperation rates. Results A total of 95 patients undergoing skull base surgery for resection of ENB were included. Mean age, BMI, operation time, and post-operative length of stay (LOS) of the cohort were 53.6 ± 16.2 years, 29.1 ± 6.5, 392.0 ± 204.6 minutes, and 5.8 ± 4.6 days, respectively. In total, 31 patients (32.6%) experienced at least one 30-day adverse event, which included blood transfusion intra-operatively or within 72 hours from the operation (22.1%), readmission (10.7%), intubation >48 hours (7.4%), reintubation (4.2%), organ or space infection (4.2%), reoperation (4.0%), superficial or deep surgical site infection (2.1%), sepsis (2.1%), pulmonary embolism (1.1%), and myocardial infarction (1.1%). Patients who experienced at least one adverse event had significantly higher operation time (486.8 ± 230.4 vs. 347.5 ± 176.2 minutes, p = 0.002), LOS (9.2 ± 5.6 days vs. 4.2 ± 3.0, p < 0.001), and lower hematocrit (37.3 ± 5.9 vs. 41.2 ± 3.8, p < 0.001) and albumin levels (3.8 ± 0.6 vs. 4.2 ± 0.3, p = 0.009). Patients with a higher American Society of Anesthesiologists (ASA) score (HR = 2.39; p = 0.047) or longer operation time (HR = 1.004; p = 0.001) had a significantly higher risk for experiencing adverse events. Obesity was not associated with different intra- or post-operative outcomes, but older patients had shorter operations ( p = 0.002) and LOS ( p = 0.0014). Conclusion Longer operation time and lower pre-operative hematocrit and albumin levels may all increase complication rates in ENB resection. Patients with high ASA score or more advanced age may have different short-term outcomes.


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