Adverse Events and Their Risk Factors Following Intra-articular Corticosteroid Injections of the Ankle or Subtalar Joint

2019 ◽  
Vol 40 (6) ◽  
pp. 622-628 ◽  
Author(s):  
Sophia E. Anderson ◽  
Bart Lubberts ◽  
Anne D. Strong ◽  
Daniel Guss ◽  
A. Holly Johnson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Event ◽  
Adverse Events ◽  
Subtalar Joint ◽  
Corticosteroid Injection ◽  
Adverse Event Rate ◽  
Multivariable Logistic Regression Analysis ◽  
Fluoroscopic Guidance ◽  
Total Cohort ◽  
Diabetes Status

Background: Little data exists regarding the incidence of adverse events and their associated risk factors following intra-articular corticosteroid injection of the ankle and subtalar joint. The aim of this study was to determine the complication rate associated with such injections and to identify any predictive risk factors. Methods: Adult patients who had received an intra-articular ankle or subtalar joint injection between January 2000 and April 2016 at one of 3 regional hospitals (2 level 1 trauma centers and 1 community hospital) were included. Patients with prior intra-articular injection of corticosteroid into the ankle or subtalar joint were excluded. Explanatory variables were sex, age, race, body mass index, diabetes status, tobacco use, presence of fluoroscopic guidance, location of intra-articular injection, and administering physician’s years of experience. Results: Of the 1708 patients included in the final cohort, 99 patients (5.8%) had a total of 104 adverse events within 90 days postinjection. The most prevalent types of adverse events were postinjection flare in 78 patients (4.6% of total cohort, 75% of adverse events) followed by skin reaction in 10 patients (0.6% of total cohort, 9% of adverse events). No infections were noted. Multivariable logistic regression analysis found that intra-articular injection in the subtalar ( P = .004) was independently associated with development of an adverse event. Fluoroscopic guidance was not found to be protective of an adverse event compared to nonguided injections ( P = .476). Conclusion: The adverse event rate following intra-articular ankle or subtalar joint corticosteroid injection was 5.8%, with postinjection flare being the most common complication. Infections following injection were not reported. Injection into the subtalar joint was independently associated with the development of an adverse event after intra-articular corticosteroid injection, and this was not mitigated by the use of fluoroscopic guidance. Level of Evidence: Level III, retrospective comparative study.

scholarly journals Delayed Ileal Pouch Anal Anastomosis Has a Lower 30-Day Adverse Event Rate: Analysis From the National Surgical Quality Improvement Program

2018 ◽  
Vol 24 (8) ◽  
pp. 1833-1839 ◽  
Author(s):  
Bharati Kochar ◽  
Edward L Barnes ◽  
Anne F Peery ◽  
Katherine S Cools ◽  
Joseph Galanko ◽  
...  
Keyword(s):  
Adverse Event ◽  
Quality Improvement ◽  
Adverse Events ◽  
Ileal Pouch ◽  
Ileal Pouch Anal Anastomosis ◽  
Quality Improvement Program ◽  
Adverse Event Rate ◽  
Improvement Program ◽  
Surgical Quality ◽  
Anal Anastomosis

Abstract Background Ulcerative colitis (UC) patients requiring colectomy often have a staged ileal pouch anal anastomosis (IPAA). There are no prospective data comparing timing of pouch creation. We aimed to compare 30-day adverse event rates for pouch creation at the time of colectomy (PTC) with delayed pouch creation (DPC). Methods Using prospectively collected data from 2011–2015 through the National Surgical Quality Improvement Program, we conducted a cohort study including subjects aged ≥18 years with a postoperative diagnosis of UC. We assessed 30-day postoperative rates of unplanned readmissions, reoperations, and major and minor adverse events (AEs), comparing the stage of the surgery where the pouch creation took place. Using a modified Poisson regression model, we estimated risk ratios (RRs) with 95% confidence intervals (CIs) adjusting for age, sex, race, body mass index, smoking status, diabetes, albumin, and comorbidities. Results Of 2390 IPAA procedures, 1571 were PTC and 819 were DPC. In the PTC group, 51% were on chronic immunosuppression preoperatively, compared with 15% in the DPC group (P < 0.01). After controlling for confounders, patients who had DPC were significantly less likely to have unplanned reoperations (RR, 0.42; 95% CI, 0.24–0.75), major AEs (RR, 0.72; 95% CI, 0.52–0.99), and minor AEs (RR, 0.48; 95% CI, 0.32–0.73) than PTC. Conclusions Patients undergoing delayed pouch creation were at lower risk for unplanned reoperations and major and minor adverse events compared with patients undergoing pouch creation at the time of colectomy.

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.

ENDOSCOPIC PAPILLECTOMY FOR EARLY AMPULLARY NEOPLASTIC LESIONS - A CASE SERIES ANALYSIS

2020 ◽  
Vol 57 (3) ◽  
pp. 300-305
Author(s):  
Nelson Silveira CATHCART JR ◽  
Raquel Canzi Almada de SOUZA ◽  
Rafael William NODA ◽  
Eloy TAGLIERI ◽  
José Celso ARDENGH ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Residual Tumor ◽  
High Grade Dysplasia ◽  
Adverse Event Rate ◽  
High Grade ◽  
Technical Success ◽  
Curative Intent ◽  
Endoscopic Papillectomy ◽  
Neoplastic Lesions

ABSTRACT BACKGROUND: Endoscopic papillectomy has been conceived as a less invasive therapeutic option for treatment of early neoplastic lesions located at the major duodenal papilla. OBJECTIVE: Evaluating patients with early ampullary lesions who underwent curative intent endoscopic papillectomy related to technical success (histopathological tumor margin assessment) and safety (adverse event rate). METHODS: A retrospective study including consecutive patients who underwent curative intent endoscopic papillectomy for demographic, histopathological and pre-/post-procedural clinical assessment. Endpoints were technical success (histopathological residual tumor assessment) and adverse events rates. RESULTS: A total of 21 medical records patients with a female predominance (13 cases, 61.9%) were included. The tumor was incidental in 8 (38%) cases. Negative residual tumor resection margin rate was 72% (15 cases); three of these cases confirmed high-grade dysplasia in the resected specimen, and six cases were invasive neoplasia. Tumoral recurrence was seen in two cases, and median follow-up time was 12 months, with a 23% loss rate (five patients). Six (28.5%) patients had adverse events, all of them early (bleeding and pancreatitis); none of them required surgical intervention and there was no mortality. CONCLUSION: Endoscopic papillectomy allowed for technical successful procedure with complete removal of ampullary neoplastic lesions in the majority of cases with acceptable adverse event rates. Recurrence rate should be carefully assessed in further studies. There was a recent increase in the number of procedures. There was also a low correlation between pre- and post-histopathological assessment regarding the presence of invasive carcinoma and adenoma with high grade dysplasia, with a predominance of superficial neoplastic adenomatous lesions.

scholarly journals Surgical timing and presence of a vitreoretinal fellow on postoperative adverse events following pars plana vitrectomy

2018 ◽  
Vol 30 (1) ◽  
pp. 81-87
Author(s):  
Ryan A Shields ◽  
Cassie A Ludwig ◽  
Matthew A Powers ◽  
Jonathan D Tijerina ◽  
Ira H Schachar ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Pars Plana Vitrectomy ◽  
Vitreous Hemorrhage ◽  
Adverse Event Rate ◽  
Start Time ◽  
School Of Medicine ◽  
Pars Plana ◽  
Independent Risk Factors ◽  
Postoperative Vitreous Hemorrhage

Introduction: To evaluate the adverse event rate following pars plana vitrectomy as a function of surgical start time and the presence of a vitreoretinal fellow. Methods: Single-institution retrospective cohort study of patients undergoing pars plana vitrectomy from 1 January 2016 to 31 December 2016 at Stanford University School of Medicine (Palo Alto, CA, USA). Records were reviewed for surgical start time, the presence of vitreoretinal fellow, and postoperative adverse events defined as any finding deviating from the expected postoperative course requiring observation or intervention. Results: A total of 310 pars plana vitrectomies were performed. There was no statistical difference in the rate of any adverse event when comparing cases starting after 16:01 (9/13, 69.2%) and after 12:01 (42/99, 42.4%) to a morning start time (69/198, 34.9%, adjusted p = 0.083). There was a statistically significant increase in the risk of postoperative vitreous hemorrhage with afternoon and evening cases as compared to morning cases (adjusted p = 0.021). In addition, there was no difference in any adverse event with a fellow present (93/244, 38.1%) compared to without (27/66, 40.9%, adjusted p = 0.163). There was a higher risk of postoperative hypotony when a fellow was involved (6.6% vs 0%, p = 0.028), though this difference disappeared after adjusting for confounders (adjusted p = 0.252). There was no difference in the length of surgery with and without a fellow (49 vs 54 min, respectively; p = 0.990). Discussion: Afternoon start time and the presence of a fellow were not independent risk factors for postoperative adverse events.

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.

Association between PD-L1 inhibitor, tumor site and adverse events of potential immune etiology within the US FDA adverse event reporting system

Immunotherapy ◽  
2021 ◽  
Author(s):  
Omar Abdel-Rahman
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Special Interest ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Multivariable Logistic Regression Analysis ◽  
Tumor Type ◽  
Related Factors ◽  
Event Reporting

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.

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.

Missing data may lead to changes in hip fracture database studies

2018 ◽  
Vol 100-B (2) ◽  
pp. 226-232 ◽  
Author(s):  
B. A. Basques ◽  
R. P. McLynn ◽  
A. M. Lukasiewicz ◽  
A. M. Samuel ◽  
D. D. Bohl ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Event ◽  
Quality Improvement ◽  
Hip Fracture ◽  
Missing Data ◽  
Adverse Events ◽  
Elderly Patients ◽  
National Database ◽  
Improvement Program ◽  
Surgical Quality

Aims The aims of this study were to characterize the frequency of missing data in the National Surgical Quality Improvement Program (NSQIP) database and to determine how missing data can influence the results of studies dealing with elderly patients with a fracture of the hip. Patients and Methods Patients who underwent surgery for a fracture of the hip between 2005 and 2013 were identified from the NSQIP database and the percentage of missing data was noted for demographics, comorbidities and laboratory values. These variables were tested for association with ‘any adverse event’ using multivariate regressions based on common ways of handling missing data. Results A total of 26 066 patients were identified. The rate of missing data was up to 77.9% for many variables. Multivariate regressions comparing three methods of handling missing data found different risk factors for postoperative adverse events. Only seven of 35 identified risk factors (20%) were common to all three analyses. Conclusion Missing data is an important issue in national database studies that researchers must consider when evaluating such investigations. Cite this article: Bone Joint J 2018;100-B:226–32.

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