Risk Factors For Adverse Events Research Articles

ERCP in patients over 90 years old: Safety and efficacy comparison with a younger cohort.

Background and study aims As life expectancy increases worldwide, so does the prevalence of biliary tract and pancreatic disorders, resulting in rising demand for invasive procedures such as endoscopic retrograde cholangiopancreatography (ERCP) in the elderly. Few studies have assessed the safety of ERCP in patients 90 years and older, particularly among the Hispanic population. The primary aim of this study was to determine the technical success and adverse events (AEs) associated with ERCP in patients 90 years of age or older in comparison to a younger cohort of patients. Patients and methods A retrospective analysis of all ERCPs done at our institution from 2012 to 2018 was performed. Three hundred ERCPs in patients < 90 years old and all 28 ERCPs done in patients ≥ 90 years old were included in the analysis. Results ERCPs were successfully completed in 96.4% of patients > 90 years old and 96.3% of the < 90-year-old cohort (realtive risk [RR] 1.00, confidence interval 0.92-1.07). There was no difference in the rate of periprocedural AEs. Post-ERCP AEs occurred in 7.1% and 3.0% in patients aged < 90 and > 90 years, respectively (RR 2.38, 0.54-10.48). No deaths were directly attributed to the procedure; however, inpatient mortality was higher in the group aged > 90 years. Conclusions ERCP is safe and effective in nonagenarian patients, and advanced age should not be considered an independent risk factor for AEs nor a contraindication for the procedure.

Association between estimated pulse wave velocity and all-cause mortality in patients with coronary artery disease: a cohort study from NHANES 2005–2008

BackgroundArterial stiffness has been shown to be an independent risk factor for adverse events and all-cause mortality in patients. Although PWV is the gold standard for pulse wave velocity, its application in clinical practice is limited by the high cost and complexity. ePwv is a new, simple, non-invasive indicator of arterial stiffness. The aim of this study was to assess the relationship between ePwv and all-cause mortality in patients with coronary artery disease.MethodsThis is a cohort study, selected from NHANES 2005 to 2008, 402 patients with coronary artery disease were included. The ePWV was divided into two groups and KM survival curves were used to calculate cumulative mortality in patients with coronary artery disease. Restricted cubic spline were used to represent the relationship between ePWV and all-cause mortality in patients with coronary artery disease. Cox regression was used to diagnose the relationship between ePwv and all-cause mortality.ResultsThe mean age of the study subjects was 68.5 ± 11.8 years, of which 282 (70.1%) were men and 120 (29.9%) were women. During 180 months of follow-up, 160 all-cause mortality occurred. KM survival curves indicated that all-cause mortality increased with increasing ePWV. The relationship between ePWV and all-cause mortality in patients with coronary artery disease was verified by cox models. Patients in higher ePWV tertile tended to have higher all-cause mortality. After complete multivariate adjustment, an increase in ePWV was positively associated with all-cause mortality (HR = 1.180, 95% confidence interval (CI): 1.056–1.320). The multivariate-adjusted HR and 95% CI for the highest ePWV tertile was 1.582 (95% CI: 0.968–2.587) compared to the lowest tertile. In addition, the association between ePWV and mortality was visualized employing restricted spline curves, in which we found curves indicating a possible threshold for the effect of ePWV on all-cause mortality, with HR less than 1 when ePWV was less than 11.15 m/s; thereafter, there was a tendency for HR to increase with enhanced ePWV. Subgroup analysis showed that the correlation between ePWV and mortality persisted in population subgroups.ConclusionOur findings suggest that higher ePWV is associated with increased all-cause mortality in patients with coronary artery disease, particularly when ePWV exceeds 11.15 m/s.

Bone Mineral Density is Associated With Adverse Events but not Patient-Reported Outcomes in Total Hip and Knee Arthroplasty

BackgroundAlthough osteoporosis is common in patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA), its impact on postoperative outcomes has been inadequately studied. The purpose of this study was to evaluate the impact of bone mineral density (BMD) on adverse events and patient-reported outcomes in THA and TKA. MethodsA series of 1,306 THA and 1,046 TKA patients who had received osteodensitometry were analyzed retrospectively. Rates of readmission, complication, transfusion, and patient-reported outcome were correlated with BMD. Multivariable logistic regression models were used to assess the relationship between osteoporosis and adverse events. ResultsOsteoporosis patients showed higher rates of 90-day readmission (THA: 8.5% versus 4.0%, P = .02; TKA: 8.9% versus 4.4%, P = .04) and transfusion (THA: 6.8% versus 1.2%, P < .001; TKA: 5.4% versus 1.5%, P = .005). After THA, rates of complications requiring intensive care management (5.1% versus 0.7%, P < .001) and rates of medical complications (3.5% versus 0.6%, P = .001) were increased. After TKA, rates of surgical complications (2.8% versus 0.8%, P = .04) were increased. Postoperatively, osteoporosis patients improved to comparable patient-reported outcomes as patients who had normal BMD. Multivariable logistic regression analyses revealed osteoporosis as an independent risk factor for readmissions, complications, and transfusions. ConclusionOsteoporosis is a risk factor for adverse events after THA and TKA. Affected patients show similar improvement of patient-reported outcome compared to patients who have normal BMD. As osteoporosis is modifiable, a systematic screening of patients scheduled for THA or TKA should be discussed.

Strong impact of sarcopenic state defined by skeletal muscle mass index on postoperative complication of Crohn's disease patients

BackgroundMalnutrition impacts the clinical course of Crohn's disease; however, there is little evidence of its influence on perioperative adverse events. We assessed whether nutritional indicators are associated with postoperative complications in surgical treatment of Crohn's disease. Methods137 patients with Crohn's disease who underwent surgical treatment between January 2011 and December 2020 were included. Skeletal muscle index was calculated by a single CT slice. We analyzed the risk factors for adverse events. Results37 % of patients had postoperative complications. Adverse events occurred more frequently in patients with high serum C-reactive protein, low serum albumin, prognostic nutritional index <38.3, skeletal muscle index <38.9 cm2/m2, abdominoperineal resection, long surgical duration, and mass hemorrhage. Among patients with skeletal muscle index <38.9 cm2/m2, patients who experienced adverse events had higher visceral fat index compared with those who did not (0.85 vs. 0.45, P = 0.04). Multivariate analysis revealed that skeletal muscle index <38.9 cm2/m2 and low serum albumin were the independent risk factors for postoperative complications (Odds ratio, 2.85; 95 % confidence interval, 1.13–7.16; P = 0.03, 2.62; 1.09–6.26; P = 0.03, respectively). Separated by sex, low serum albumin (<3.5 and <2.8 g/dL, male and female, respectively) and skeletal muscle index (<38.9 and <36.6 cm2/m2, male and female, respectively) were statistically related to postoperative complications. ConclusionsSkeletal muscle index is the most useful nutritional predictor of postoperative complications in Crohn's disease patients among other nutritional indices. We believe that these patients are at high risk of postoperative complications and need appropriate nutritional support in the perioperative period.

Real-World Predictors of Severe Neutropenia Associated with Palbociclib and Endocrine Therapy for Metastatic Breast Cancer in Japanese Patients.

Therapy for patients of metastatic breast cancer based on palbociclib, a cyclin-dependent kinase 4/6 inhibitor, has been approved in Japan. However, the risk factors for palbociclib-induced severe neutropenia in Japanese patients are rarely reported. Hence, the present study is aimed to identify the risk factors for adverse events requiring palbociclib dose reduction or discontinuation, and to identify the factors necessary to identify a more stable strategy for treatment continuation. This retrospective cohort analysis included patients with advanced breast cancer treated with 125 mg/d palbociclib. We demonstrated that severe neutropenia required significant dose reduction or therapy cessation. Most (77%) of the patients had severe neutropenia within the three courses. Risk factors for grade 3 or higher included low neutrophil counts (< 3250 /µL) before treatment [odds ratio (OR) = 9.10, 95% confidence interval (CI) (2.80-29.41), p < 0.001] and high age-adjusted Charlson comorbidity index (> 9) [OR = 1.64, 95% CI (1.09-2.48), p = 0.018]. Thus, low baseline neutrophil counts and high values for Age-adjusted Charlson comorbidity index are prospective predictive markers for palbociclib-induced severe neutropenia.

The impact of gastroenterology fellowship involvement on the ERCP outcomes

Aims: This study aimed whether the companionship of the gastroenterology fellowships to operators performing high-volume ERCP, would adversely affect the safety and success of the procedure.&#x0D; Methods: This retrospective observational study included 964 patients with naïve papilla who underwent ERCP between February 2019 and May 2022. Procedures with fellowship involvement were compared with procedures performed only by the expert operator in terms of cannulation success, procedure time, cannulation time, unintended PD cannulation, difficult cannulation, cannulation techniques, and post-procedure adverse events. &#x0D; Results: The two groups were similar in terms of procedure difficulty, successful cannulation in the first session, overall successful canulation, unintended PD cannulation, difficult cannulation rates, and cannulation techniques. The median procedure time was significantly higher in the fellowship involvement group compared to the other group (p=0.008). There was no difference between the two groups in terms of adverse events after the procedure (p&gt;0.05). Procedure difficulty were found an independent risk factor of adverse events in the multivariate analysis (Odds ratio: 2.3; 95% Cl 1.4-3.6; p

Diabetes Mellitus and Its Association with Adverse In-Hospital Outcomes in Patients with COVID-19-A Nationwide Study.

Diabetes mellitus (DM) represents a relevant risk factor regarding morbidity and mortality worldwide. However, only limited data exist regarding the impact of DM on the clinical outcome of patients with COVID-19 infection. All hospitalized patients with confirmed COVID-19-infection (ICD-code U07.1) during the year 2020 in Germany were included in the present study. Patients were stratified regarding the co-prevalence of DM (ICD-codes E10-E14), and the impact of DM on in-hospital case fatality and in-hospital adverse events was analyzed. Overall, 176,137 hospitalizations with confirmed COVID-19 infection were documented; of these, 45,232 (25.7%) patients had an additional diagnosis of DM. Diabetic patients with COVID-19 were more often of male sex and 7 years older (median 76.0 (IQR: 66.0-83.0) vs. 69.0 (52.0-81.0) years, p < 0.001). COVID-19 patients with DM demonstrated an aggravated comorbidity profile, as reflected by a higher Charlson comorbidity index (6.0 (IQR: 4.0-8.0) vs. 3.0 (1.0-5.0), p < 0.001). Risk for pneumonia (OR 1.38 (95% CI: 1.35-1.41), p < 0.001), acute respiratory distress syndrome (OR 1.53 (95% CI: 1.47-1.60), p < 0.001), and need for intensive care (21.3% vs. 13.3%, p < 0.001) were increased in DM patients. DM was an independent risk factor for acute kidney failure (OR 1.49 (95% CI: 1.44-1.53), p < 0.001), dialysis (OR 1.56 (95% CI: 1.47-1.66), p < 0.001), mechanical ventilation (OR: 1.49 (95% CI: 1.43-1.56), p < 0.001), extracorporeal membrane oxygenation (OR 1.44 (95% CI: 1.27-1.62), p < 0.001), major adverse cardiac and cerebrovascular events (OR: 1.24 (95% CI: 1.20-1.27), p < 0.001), and in-hospital mortality (OR: 1.26 (95% CI: 1.22-1.30), p < 0.001). In patients with COVID-19-infection, DM is a relevant risk factor for adverse events, including mortality. The vulnerable patient group of diabetics with COVID-19 requires intense medical care and monitoring during hospitalization.

Incidence and Risk Factors of Postoperative Complications After Rhinoplasty: A Multi-Institutional ACS-NSQIP Analysis.

Despite the popularity of rhinoplasty, outcome research has been mainly limited to single-surgeon or single-institution reports. Therefore, we performed a multi-institutional analysis to present a broader portrait of the postoperative outcomes and risk factors for adverse events after rhinoplasty surgery. We reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2009-2019) to identify patients who underwent rhinoplasty. The postoperative outcomes of interest included 30-day mortality, reoperation, readmission, and surgical and medical complications. We also analyzed risk factors for complication occurrence, including patient comorbidities and preoperative laboratory values. We identified 835 patients, 72% (n=602) of whom underwent a primary, 21% (n=175) a secondary, and 6.7% (n=58) a cleft nasal deformity procedure. The average patient age was 41±17 years, with most patients being female (n=472; 57%) and white (n=643; 77%). Complications rates were generally low, with reoperation (n=19; 2.3%) and superficial incisional infection (n=9; 1.1%) account for the most common general and surgical adverse event, respectively. Multivariable analysis revealed male sex (P=0.04) and higher ASA scores (P<0.0001) as risk factors for complications. Low serum albumin (P=0.04) and hematocrit (P=0.003) levels were associated with the occurrence of any complication, whereas low serum albumin (P=0.02) also correlated with the incidence of surgical adverse events. Complication rates after rhinoplasty were overall low and seemed to correlate with male sex and ASA scores. We identified preoperative albumin and hematocrit as predictive biomarkers of adverse events. Preoperative nutritional optimization and management of low hematocrit may improve postoperative outcomes.

Comparison of 95% effective dose of remimazolam besylate and propofol for gastroscopy sedation on older patients: A single-centre randomized controlled trial.

Advanced age is an important risk factor for adverse events during procedural sedation. Remimazolam is safe and effective in gastroscopic sedation. However, the ideal dose and application for older patients are not well known. We aim to investigate its 95% effective dose (ED95) for older patients undergoing gastroscopy and to assess its safety and efficacy, with propofol as the comparison. The trial consists of 2 parts, patients aged >65 years and scheduled for outpatient painless gastroscopy were enrolled. In the first part, Dixon's up-and-down methodology was used to determine the ED95 of remimazolam besylate and propofol for gastroscopic insertion, in combination with 0.2 μg/kg remifentanil. In the second part, patients in each group received 0.2 μg/kg remifentanil and ED95 dose of the study drugs for sedation induction, supplemental doses were added to maintain sedation depth when necessary. The primary outcome was the incidence of adverse events. The secondary outcome was the recovery time. The ED95 of remimazolam besylate and propofol induction were 0.2039 (95% confidence interval 0.1753-0.3896) mg/kg and 1.9733 (95% confidence interval 1.7346-3.7021) mg/kg respectively. Adverse events were reported in 26 (40.6%) patients in the remimazolam group and 54 (83.1%) in the propofol group (P< .0001), whereas the remimazolam group presented a higher incidence of hiccups (P= .0169). Besides, the median time to awakening was approximately 1 min shorter with remimazolam than with propofol (P< .05). For older patients undergoing gastroscopy, the ED95 dose of remimazolam is a safer alternative than propofol when inducing the same sedation depth.

Daptomycin Exposure as a Risk Factor for Daptomycin-Induced Eosinophilic Pneumonia and Muscular Toxicity.

High-dose daptomycin is increasingly used in patients with bone and joint infection (BJI). This raises concerns about a higher risk of adverse events (AEs), including daptomycin-induced eosinophilic pneumonia (DIEP) and myotoxicity. We aimed to examine pharmacokinetic and other potential determinants of DIEP and myotoxicity in patients with BJI receiving daptomycin. All patients receiving daptomycin for BJI were identified in a prospective cohort study. Cases were matched at a 1:3 ratio, with controls randomly selected from the same cohort. Bayesian estimation of the daptomycin daily area under the concentration-time curve over 24 hours (AUC24h) was performed with the Monolix software based on therapeutic drug monitoring (TDM) data. Demographic and biological data were also collected. Risk factors of AEs were analyzed using Cox proportional hazards model. From 1130 patients followed over 7 years, 9 with DIEP, 26 with myotoxicity, and 106 controls were included in the final analysis. Daptomycin AUC24h, C-reactive protein, and serum protein levels were associated with the risk of AEs. The adjusted hazard ratio of DIEP or myotoxicity was 3.1 (95% confidence interval [CI], 1.48-6.5; P < .001) for daptomycin AUC24h > 939 mg/h/L, 9.8 (95% CI, 3.94-24.5; P < .001) for C-reactive protein > 21.6 mg/L, and 2.4 (95% CI, 1.02-5.65; P = .04) for serum protein <72 g/L. We identified common determinants of DIEP and myotoxicity in patients with BJI. Because the risk of AEs was associated with daptomycin exposure, daptomycin TDM and model-informed precision dosing may help optimize the efficacy and safety of daptomycin treatment in this setting. A target AUC24h range of 666 to 939 mg/h/L is suggested.

Continuing Medical Education Questions: December 2023.

Article Title: Preoperative Risk Factors for Adverse Events in Adults Undergoing Bowel Resection for Inflammatory Bowel Disease: 15-Year Assessment of the American College of Surgeons National Surgical Quality Improvement Program.

Standing Blood Pressure and Risk of Falls, Syncope, Coronary Heart Disease, and Mortality.

ACC/AHA guidelines caution against the use of antihypertensive therapy in the setting of low standing systolic BP (SBP) < 110 mm Hg due to unclear benefits. The Atherosclerosis Risk in Communities (ARIC) Study measured supine and standing SBP in adults aged 45-64 years between 1987 and 1989. We used Cox regression to evaluate the associations of low standing SBP (<110 mm Hg) with risk of falls, syncope, coronary heart disease (CHD), and mortality through December 31, 2019. Falls and syncope were ascertained by hospitalization and outpatient claims; CHD events were adjudicated. Associations were examined overall and in strata of hypertension stage, 10-year atherosclerotic cardiovascular disease (ASCVD) risk, age, and sex. Among 12,467 adults followed a median of 24 years (mean age at enrollment 54.1 ± 5.8 years, 55% women, 26% Black adults), 3,000 (24%) had a standing SBP < 110 mm Hg. A standing SBP < 110 mm Hg compared to standing SBP ≥ 110 mm Hg was not significantly associated with falls or syncope, and was associated with a lower risk of CHD events and mortality with HRs of 1.02 (95% CI 0.94, 1.11), 1.02 (0.93, 1.11), 0.88 (0.80, 0.97), and 0.91 (0.86, 0.97), respectively. There were no clinically meaningful differences when stratified by hypertension stage, 10-year ASCVD risk, age, and sex. In this community-based population, low standing SBP was common and not significantly associated with falls or syncope, but was associated with a lower risk of CHD and mortality. These findings do not support screening for low standing BP as a risk factor for adverse events.

Identifying risk factors for adverse events of pyridoxal phosphate in infantile epileptic spasms syndrome

IntroductionInfantile epileptic spasms syndrome (IESS) is characterized by epileptic spasms, regardless of hypsarrhythmia on electroencephalogram or neurodevelopmental delay. In Japan, pyridoxal 5′-phosphate (PLP) is often used as the first-line treatment for IESS because it is effective in a certain number of patients. Although several studies have reported serious adverse events following PLP treatment, no study has investigated the risk factors for such occurrences. ObjectiveTo investigate adverse events associated with PLP therapy for the treatment of IESS and to identify the associated risk factors. Materials and methodsWe retrospectively evaluated adverse events in 59 patients with IESS at Tottori University Hospital between January 1995 and September 2022. We subsequently collected and analyzed their clinical data and analyzed the risk factors associated with each adverse event. The cutoff values and relative risk (RR) were analyzed for items with significant associations with adverse events. ResultsTwenty-seven (51.9%) participants experienced adverse events, including vomiting in 16 participants (59.3%), elevated liver enzyme levels in 15 participants (55.6%), and rhabdomyolysis in two participants (3.4%). No significant differences were observed between the non-adverse events group and the overall adverse events group, as well as between the non-adverse events group and the vomiting group, in terms of the factors examined. However, when comparing the non-adverse events group with the group with elevated liver enzyme levels, age at PLP treatment showed a negative correlation, whereas PLP dose showed a positive correlation with elevated liver enzyme levels. The cutoff dose was 40 mg/kg/day (73.3% sensitivity and 60.7% specificity), and the cutoff age was 9 months (100% sensitivity and 40.0% specificity). RRs of doses ≥40 mg/kg/day and age <9 months were 2.6 and 3.6, respectively. ConclusionsAdverse events of PLP therapy, including vomiting, elevated liver enzymes, and rhabdomyolysis, were observed in approximately half of the participants. Age under 9 months and a dose ≥40 mg/kg/day were identified as risk factors for elevation of liver enzymes on PLP treatment in infants with IESS, with rhabdomyolysis can occur in the younger or higher dose cases.

Preoperative Risk Factors for Adverse Events in Adults Undergoing Bowel Resection for Inflammatory Bowel Disease: 15-Year Assessment of the American College of Surgeons National Surgical Quality Improvement Program.

Older adults with inflammatory bowel disease (IBD) are at higher risk for postoperative complications as compared to their younger counterparts; however, factors contributing to this are unknown. We assessed risk factors associated with adverse IBD-related surgical outcomes, evaluated trends in emergency surgery, and explored differential risks by age. Using the American College of Surgeons National Surgical Quality Improvement Program database, we identified adults ≥18 years of age who underwent an IBD-related intestinal resection from 2005 to 2019. Our primary outcome included a 30-day composite of mortality, readmission, reoperation, and/or major postoperative complication. Overall, 49,746 intestinal resections were performed with 9,390 (18.8%) occurring among older adults with IBD. Nearly 37% of older adults experienced an adverse outcome as compared to 28.1% among younger adults with IBD ( P < 0.01). Among all adults with IBD, the presence of preoperative sepsis (adjusted odds ratio [aOR], 2.08; 95% confidence interval [CI] 1.94-2.24), malnutrition (aOR, 1.22; 95% CI 1.14-1.31), dependent functional status (aOR, 6.92; 95% CI 4.36-11.57), and requiring emergency surgery (aOR, 1.50; 95% CI 1.38-1.64) increased the odds of an adverse postoperative outcome, with similar results observed when stratifying by age. Furthermore, 8.8% of surgeries among older adults were emergent, with no change observed over time ( P = 0.16). Preoperative factors contributing to the risk of an adverse surgical outcome are similar between younger and older individuals with IBD, and include elements such as malnutrition and functional status. Incorporating these measures into surgical decision-making can reduce surgical delays in older individuals at low risk and help target interventions in those at high risk, transforming care for thousands of older adults with IBD.

Clinical significance of high monocyte counts for the continuous treatment with nintedanib

BackgroundNintedanib is now widely used to treat interstitial lung disease (ILD). Adverse events, which occur in not a few patients, make it difficult to continue nintedanib treatment, but the risk factors for adverse events are not well understood.MethodsIn this retrospective cohort study, we enrolled 111 patients with ILDs treated with nintedanib and investigated the factors involved in starting dosage reduction, withdrawal, or discontinuation within 12 months, even with appropriate symptomatic treatment. We also examined the efficacy of nintedanib in reducing the frequency of acute exacerbations and the prevention of pulmonary function reduction.ResultsPatients with high monocyte counts (> 0.454 × 109/L) had a significantly higher frequency of treatment failure, such as dosage reduction, withdrawal, or discontinuation. High monocyte count was as significant a risk factor as body surface area (BSA). Regarding efficacy, there was no difference in the frequency of acute exacerbations or the amount of decline in pulmonary function within 12 months between the normal (300 mg) and reduced (200 mg) starting dosage groups.ConclusionOur study results indicate that patients with higher monocyte counts (> 0.454 × 109/L) should very careful about side effects with regard to nintedanib administration. Like BSA, a higher monocyte count is considered a risk factor for nintedanib treatment failure. There was no difference in FVC decline and frequency of acute exacerbations between the starting doseage of nintedanib, 300 mg and 200 mg. Considering the risk of withdrawal periods and discontinuation, a reduced starting dosage may be acceptable in the patients with higher monocyte counts or small body sizes.

Adverse Events After Surgical Treatment of Adult Diaphyseal Forearm Fractures: a Retrospective Analysis of 470 Patients.

The incidence of and risk factors for adverse events after internal fixation of diaphyseal forearm fractures have not been well defined in the current literature. The objective of this study was to estimate the incidence of adverse events after diaphyseal forearm fracture surgery in adults and explore potential risk factors for adverse events. We conducted a retrospective, multicenter, cohort study in which we evaluated all diaphyseal forearm fractures between 2009 and 2019 in patients presenting to 4 trauma hospitals in southern Finland. Patients <16 years of age and fracture-dislocations were excluded. There were 470 patients included in this study. Patient records were evaluated to identify and analyze adverse events. There were 202 patients with both-bone fractures, 164 patients with isolated ulnar fractures, and 104 patients with isolated radial fractures. In total, 146 patients (31%) experienced an adverse event; 83 (18%) had major adverse events (persistent or requiring surgical intervention). The patients underwent procedures performed by 185 different surgeons. The median number of operations for a single surgeon was 2 (range, 1 to 12). The most common major adverse events were plate and screw-related issues (6%), nonunion (5%), persistent nerve injuries (4%), and refractures (4%). Higher body mass index, Gustilo-Anderson type-II open fractures, both-bone fractures, isolated radial fractures, and operations performed by junior residents were found to be risk factors for adverse events in the multivariable analysis. Adverse events after diaphyseal forearm fracture surgery are common. We recommend concentrating these operations in a limited team of surgeons and restricting inexperienced surgeons from operating on these fractures without supervision. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Demographical risk factors of adverse events following immunisation of CoronaVac in Jambi, Indonesia

Background and purpose: Slow uptake of COVID-19 vaccination might be associated with the adverse events after vaccination. This study aims to evaluate the association between demographical factors and COVID-19 vaccine adverse events in Jambi, Indonesia Methods: We conducted a cross-sectional study with a total population sampling. Data were collected with a structured questionnaire. We included adults vaccinated for the first dose with CoronaVac in Putri Ayu Public Health Center between March 15th and June 3rd, 2021, accounted for 522 persons. Statistical analysis was done using IBM SPSS 26.0. Multivariate logistic regression analysis was used to analyze the predictive models. Results: This Out of 522 respondents included, immune reactions (34.1%) were the most common adverse effects reported by the respondents. Multivariate analysis showed that respondents with no family members or friends exposed to COVID-19 are less likely to experience puncture site reaction with an OR of 0.28 (95%CI: 0.09-0.92; p=0.036). Those with no history of mental disorders were also less likely to experience the adverse event with an OR of 0.12 (95%CI: 0.024-0.62; p=0.011). As for other reactions, those in the 26-35 years old category are more likely to experience other adverse event reactions with an OR of 11.62 (95%CI: 1.5-89.92; p=0.019). Conclusion: Based Younger respondents tend to experience more other reaction of COVID-19 vaccine adverse events than the older groups. We also found that those with no family or friends who contracted COVID-19 and no history of mental disorders are less likely to experience puncture site reaction adverse events.

Predictors for adverse events following intravesical botulinum toxin injections in men.

Intravesical botulinum toxin A (BTX-A) has been long established as treatment for overactive bladder and neurogenic bladder dysfunction. However, most published data are reported amonga female cohort. Adverse events such as intermittent self-catheterization (ISC) and urinary tract infections (UTIs) play a large role in discontinuation of therapy. There is currently limited information regarding predictive factors to appropriately counsel male patients. We retrospectively collected data on male patients undergoing their first intravesical BTX-A therapy from January 2016 to July 2021 in two high-volume centers. Data included demographics, past medical and surgical history, and urodynamic parameters. Patients were excluded if they had a long-term catheter or ISC before initiation of therapy. A total of 69 men were included in the study with a median age of 66 years. There were 18 patients with neurogenic bladder dysfunction. Thirty men had urge incontinence secondary to radical prostatectomy or bladder outflow surgery. Overall rates of ISC were 43.5%. Predictors for ISC included a baseline postvoid residual (PVR) ≥ 50 mL (odds ratio [OR]: 4.2, 95% confidence interval [CI]: 1.36-13.03, p = 0.01), BTX-A dose >100 units (OR: 4.2, 95% CI: 1.36-13.0, p = 0.01). Stress urinary incontinence was protective against ISC (OR: 0.20, 95% CI: 0.04-1.00, p = 0.049) as well as history of prostatectomy/bladder outflow obstruction (BOO) surgery (OR: 0.16, 95% CI: 0.05-0.47, p < 0.001). A multivariable logistic regression model with these factors yielded a c-statistic of 0.80 (optimism-adjusted = 0.75). An enlarged prostate was the only predictor for UTI amongour male cohort (OR: 8.0, 95% CI: 2.03-31.5, p = 0.003). This is the first study assessing risk factors of adverse events amongmen following BTX-A injection. High PVR and BTX-A dose of >100U were predictors of requiring ISC after BTX-A. Stress incontinence, previous radical prostatectomy, and BOO surgery were all protective against needing ISC post-BTX-A. An enlarged prostate was associated with development of UTI. These factors can be used to assist in counseling male patients regarding their risk of ISC and UTI.

The value of cardiac MRI in the risk stratification in patients with hypertrophic cardiomyopathy

Objective: To explore the value of cardiac magnetic resonance imaging (CMR) in the risk stratification of hypertrophic cardiomyopathy (HCM). Methods: HCM patients who underwent CMR examination in Fuwai Hospital between March 2012 and May 2013 were retrospectively enrolled. Baseline clinical and CMR data were collected and patient follow-up was performed using telephone contact and medical record. The primary composite endpoint was sudden cardiac death (SCD) or and equivalent event. The secondary composite endpoint was all-cause death and heart transplant. Patients were divided into SCD and non-SCD groups. Cox regression was used to explore risk factors of adverse events. Receiver operating characteristic (ROC) curve analysis was used to assess the performance and the optimal cut-off of late gadolinium enhancement percentage (LGE%) for the prediction of endpoints. Kaplan-Meier and log-rank tests were used to compare survival differences between groups. Results: A total of 442 patients were enrolled. Mean age was (48.5±12.4) years and 143(32.4%) were female. At (7.6±2.5) years of follow-up, 30 (6.8%) patients met the primary endpoint including 23 SCD and 7 SCD equivalent events, and 36 (8.1%) patients met the secondary endpoint including 33 all-cause death and 3 heart transplant. In multivariate Cox regression, syncope(HR=4.531, 95%CI 2.033-10.099, P<0.001), LGE% (HR=1.075, 95%CI 1.032-1.120, P=0.001) and left ventricular ejection fraction (LVEF) (HR=0.956, 95%CI 0.923-0.991, P=0.013) were independent risk factors for primary endpoint; Age (HR=1.032, 95%CI 1.001-1.064, P=0.046), atrial fibrillation (HR=2.977, 95%CI 1.446-6.131, P=0.003),LGE% (HR=1.075, 95%CI 1.035-1.116, P<0.001) and LVEF (HR=0.968, 95%CI 0.937-1.000, P=0.047) were independent risk factors for secondary endpoint. ROC curve showed the optimal LGE% cut-offs were 5.1% and 5.8% for the prediction of primary and secondary endpoint, respectively. Patients were further divided into LGE%=0, 0<LGE%<5%, 5%≤LGE%<15% and LGE%≥15% groups. There were significant survival differences between these 4 groups whether for primary endpoint or secondary endpoint (all P<0.001) and the accumulated incidence of primary endpoint was 1.2% (2/161), 2.2% (2/89), 10.5% (16/152) and 25.0% (10/40), respectively. Conclusion: LGE is an independent risk factor for SCD events as well as all-cause death and heart transplant. LGE is of important value in the risk stratification in patients with HCM.

Risk factors for malignancy and serious infection in patients with inflammatory bowel disease: a retrospective analysis.

Patients with inflammatory bowel disease (IBD) are at increased risk of malignancy and infection compared to the general population. We aim to identifyrisk factors for malignancy or serious infection in our IBD cohort. Patients with IBD from a single tertiary referral centre were included. Demographic and clinical details, including immunosuppressant exposure, were collected and medical records retrospectively screened for adverse events, including malignancy or infection requiring hospitalisation. Logistic regression was used to evaluate risk factors for adverse events. Five hundred and forty-nine patients with IBD (340 Crohn disease (CD) and 209 ulcerative colitis (UC)) were studied. Forty-eight malignancies, including 39 (81.3%) non-melanoma skin cancers, 3 (6.3%) haematologic malignancies and 6 (15.4%) solid-organ malignancies, were identified, and 92 cases of serious infection were detected. IBD duration (odds ratio (OR) = 1.08; 95% confidence interval (CI) = 1.03-1.13) and ileocolonic CD (OR = 4.96; 95% CI = 1.13-21.71) were associated with increased odds of overall cancer. Compared with patients not previously exposed to the given class of immunosuppression assessed, the development of overall malignancy was not higher with thiopurine exposure (OR = 1.00; 95% CI = 0.50-2.24) or anti-tumour necrosis factor-alpha (TNF-α) exposure (OR = 0.78; 95% CI = 0.37-1.64). Similarly, compared with patients not exposed, infection risk was not affected by thiopurine (OR = 0.74; 95% CI = 0.46-1.20) or anti-TNF exposure (OR = 0.60; 95% CI = 0.38-0.95). Factors including ileocolonic CD and increasing IBD duration were associated with higher malignancy risk in this cohort. Compared with non-exposure, patients exposed to thiopurines were not at increased risk of malignancy or serious infection. Similarly, patients exposed to anti-TNF treatment did not experience increased rates of malignancy or serious infection compared to patients not exposed to this treatment.