Adverse Events Odds Ratio Research Articles

Impact of skeletal muscle mass on postoperative complications in oral cancer surgery

BackgroundSarcopenia is characterized by a progressive and generalized loss of skeletal muscle mass and strength. The aim of this retrospective study was to investigate the impact of skeletal muscle mass on adverse events in free-flap reconstruction for defects after oral cancer resection.ResultsOf 120 patients, recipient-site adverse events occurred in 56 patients (46.7%), and recipient-site surgical site infections occurred in 45 patients (37.5%). Skeletal muscle index was significantly associated with recipient-site adverse events in univariate analysis (P < 0.05). Lower body mass index and skeletal muscle index were significantly associated with recipient-site surgical site infection in univariate analysis (P < 0.05). In the multiple logistic regression model, a lower skeletal muscle index was a significant risk factor for recipient-site adverse events and surgical site infections (adverse events odds ratio; 3.17/P = 0.04; surgical site infection odds ratio; 3.76/P = 0.02).ConclusionsThe SMI at level Th12 was an independent factor for postoperative AEs, especially SSI, in OSCC patients with free-flap reconstruction.

Efficacy and Safety of the Utilization of Dipeptidyl Peptidase IV Inhibitors in Diabetic Patients with Chronic Kidney Disease: A Meta-Analysis of Randomized Clinical Trials.

To assess the efficacy and safety of Dipeptidyl Peptidase IV (DPP-4) inhibitors in patients with Type-2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) using level 1 evidence. The Cochrane and PubMed databases were searched from inception until January 1, 2022. RCTs that studied the efficacy and safety of DPP-4 inhibitors in diabetic patients with CKD were included. The primary efficacy outcome was assessed as the mean difference between HbA1c at the beginning and the end of each study for each arm, and the primary safety outcome was assessed as the incidence of adverse events and severe adverse events in each study. Twenty-one studies satisfied the pre-defined eligibility criteria. In assessing the efficacy of DPP-4 inhibitors in the treatment of T2DM and CKD, a total of 2917 patients under the DPP-4 inhibitors group and 2377 patients under the control group were included; The mean difference between the HbA1c of DPP-4 Inhibitor and the control group was -0.5295 with a 95% CI of -0.5337 to -0.5252. The included studies had high heterogeneity p < 0.00001 and I2 = 99%. In assessing the safety outcome and tolerability of DPP-4 inhibitors, a total of 8138 patients under the DPP-4 inhibitors group and 7517 patients under the control group were included; the odds ratio of adverse events between both groups was 0.9967 with a 95% CI of 0.9967 to 1.1047. The included studies had low heterogeneity p = 0.25 and I2 = 15%. The overall effect, Z = 0.06 (p = 0.95), was insignificant. Patients suffering from both T2DM and CKD exhibited a significantly enhanced glycemic control when treated with DPP-4 inhibitors in comparison to the control group. Furthermore, no significant difference in the incidence of adverse events was observed between the DPP-4 inhibitors and the control group.

1214. Short versus long antibiotic treatment duration for febrile urinary tract infection and acute pyelonephritis: A systematic review and meta-analysis

Abstract Background The optimal treatment duration for febrile UTI and pyelonephritis is unknown; however, multiple randomized trials have compared shorter versus longer duration. The most recent systematic review and meta-analysis was published 10 years ago. Methods With the support of a medical librarian (LY), we conducted a systematic review of the pertinent literature up to December 14, 2021. We used key terms for febrile urinary tract infection and acute pyelonephritis, treatment duration, and possible antimicrobial agents in the search. Using the evaluation tool Covidence, the identified abstracts were reviewed by the research team and potentially eligible studies were subject to full-text review. We also reviewed the references of eligible articles and scrutinized meeting abstracts. For the meta-analysis, we used SPSS version 28. For quality assessment, we used the Cochrane risk-of-bias tool. Results We screened 6732 abstracts, reviewed 21 full-text articles, and included 12 articles in this systematic review. We conducted a meta-analysis of these 12 articles (Figure 1). The Odds Ratio (OR) for clinical failure between short versus long treatment duration was 0.81 (95% CI 0.55-1.19). We also conducted a subgroup analysis for the more recent trials (#9-12 in Fig 1), with an OR 1.09 (95% CI 0.64-1.87), and the older trials (#1-8 in Fig 1), with an OR 0.68 (95% CI 0.36-1.31). The OR of experiencing an adverse event was 0.88 (95% CI 0.63-1.22) between short and long duration groups (Fig 2).Figure 1:Odds ratio of treatment failure with short versus long antibiotic course for febrile UTI and acute pyelonephritis This figure represents the odds ratio of treatment failure in short versus long duration treatment. Therefore, an odds ratio &amp;lt;1 favors short duration (i.e. lower odds of treatment failure), whereas an odds ratio &amp;gt;1 favors long duration.Figure 2:Odds ratio of adverse events with short versus long antibiotic course for febrile UTI and acute pyelonephritis This figure represents the odds ratio of a patient experiencing at least one adverse event in the short versus long duration treatment groups. Therefore, an odds ratio &amp;lt;1 favors short duration (i.e. lower odds of adverse events), whereas an odds ratio &amp;gt;1 favors long duration. Conclusion In this systematic review and meta-analysis of the evidence comparing shorter versus longer treatment durations for febrile UTI and pyelonephritis, 7 days of treatment were non-inferior to 14 days. There was no difference in adverse events between the two groups. Our findings confirm those of an earlier meta-analysis and serve as a reminder that shorter treatment durations for febrile UTI and pyelonephritis are sufficient. Disclosures All Authors: No reported disclosures

Real-world comparison of the effects of etanercept and adalimumab on well-being in non-systemic juvenile idiopathic arthritis: a propensity score matched cohort study

BackgroundEtanercept (ETN) and adalimumab (ADA) are considered equally effective biologicals in the treatment of arthritis in juvenile idiopathic arthritis (JIA) but no studies have compared their impact on patient-reported well-being. The objective of this study was to determine whether ETN and ADA have a differential effect on patient-reported well-being in non-systemic JIA using real-world data.MethodsBiological-naive patients without a history of uveitis were selected from the international Pharmachild registry. Patients starting ETN were matched to patients starting ADA based on propensity score and outcomes were collected at time of therapy initiation and 3–12 months afterwards. Primary outcome at follow-up was the improvement in Juvenile Arthritis Multidimensional Assessment Report (JAMAR) visual analogue scale (VAS) well-being score from baseline. Secondary outcomes at follow-up were decrease in active joint count, adverse events and uveitis events. Outcomes were analyzed using linear and logistic mixed effects models.ResultsOut of 158 eligible patients, 45 ETN starters and 45 ADA starters could be propensity score matched resulting in similar VAS well-being scores at baseline. At follow-up, the median improvement in VAS well-being was 2 (interquartile range (IQR): 0.0 – 4.0) and scores were significantly better (P = 0.01) for ETN starters (median 0.0, IQR: 0.0 – 1.0) compared to ADA starters (median 1.0, IQR: 0.0 – 3.5). The estimated mean difference in VAS well-being improvement from baseline for ETN versus ADA was 0.89 (95% CI: -0.01 – 1.78; P = 0.06). The estimated mean difference in active joint count decrease was -0.36 (95% CI: -1.02 – 0.30; P = 0.28) and odds ratio for adverse events was 0.48 (95% CI: 0.16 –1.44; P = 0.19). One uveitis event was observed in the ETN group.ConclusionsBoth ETN and ADA improve well-being in non-systemic JIA. Our data might indicate a trend towards a slightly stronger effect for ETN, but larger studies are needed to confirm this given the lack of statistical significance.

S1072 Safety of Endoscopic Pancreatic Necrosectomy Compared With Radiologic or Surgical Necrosectomy: A Nationwide Inpatient Analysis

Introduction: Pancreatic necrosis is an independent predictor of morbidity and mortality among patients with acute pancreatitis. Patients with pancreatic necrosis often undergo direct endoscopic necrosectomy, surgical and interventional radiology approaches exist. We compared the safety and outcomes of 3 techniques including endoscopic necrosectomy, fluoroscopy-guided necrosectomy by an interventional radiologist (IR-necrosectomy), and open necrosectomy performed by a surgeon (surgical necrosectomy). Methods: Using the Nationwide Readmissions Database, we identified hospitalised patients who underwent pancreatic necrosectomy from 2016 to 2019. They were identified using the International Classification of Diseases, 10th Revision, Procedure Coding System. Categorical variables were described using proportions and compared with Chi-Squared Test. Continuous variables were presented as means and compared using the adjusted Wald test. Adjusted odds ratios for adverse events associated with each technique were calculated using multivariable logistic regression analysis. Adjusted hazard ratios were calculated to compare mortality rates. Results: Of the 2,281 patients meeting the selection criteria, the method of pancreatic necrosectomy was as follows: endoscopy, 672 (52.1 ± 1.00 years); IR, 1,338 (53.2 ± 0.56 years); and open surgery, 271 (52.0 ± 1.36 years). The rate of mortality was lowest for endoscopy (hazard ratio (HR) 0.27; 95% CI 0.08-0.90; P = 0.033) followed by IR (HR 0.44; 95% CI, 0.20-0.98; P =0.045), compared to surgery. Endoscopy was associated with less post procedure bleeding compared to IR and surgical necrosectomy, respectively (n=74 vs n=195 vs n=102; P< 0.001); as well as lower rates of post procedure end organ damage including renal failure (n=134, vs n=449, vs n= 133; P< 0.001) and respiratory failure (n=0, vs n=18, vs n= 13; P=0.002). Endoscopy was associated with average shorter lengths of stay and total hospital costs when compared with IR and surgery, respectively (20.1 vs 25.8 vs 38.3 days; P < 0.001) and ($57K vs $76K vs $123K; P< 0.001). Conclusion: Endoscopic necrosectomy is associated with significantly lower risk of inpatient mortality, adverse events, length of stay, and cost when compared to IR and surgical approaches.Figure 1.: Kaplan-Meier survival curve comparing endoscopic, radiologic, and surgical pancreatic necrosectomy

Comparative efficacy and safety of fimasartan in patients with hypertension: A network meta-analysis of randomized controlled trials.

Hypertension is a prevalent risk factor for cardiovascular disease. Angiotensin II receptor blockers are widely prescribed to patients with hypertension, while new drugs are continuously developed. However, data on comparative efficacy and safety of novel agents, such as fimasartan, are scarce. Here, we aimed to collect clinical evidence on different angiotensin II receptor blockers using a network meta‐analysis. Randomized controlled trials whose follow‐up time is within 12 weeks were identified from eight databases via a systematic literature review. Of the 7909 possibly relevant studies, 61 studies with 14,249 adult patients were included in the analysis. These studies were further subjected to quality appraisal using Cochran's Risk of Bias, and sitting systolic blood pressure was considered the primary endpoint. A Bayesian random effect generalized linear model was used for the network meta‐analysis, and the treatment rank probability was determined. Olmesartan (standardized mean difference ‐0.987 [‐1.29, ‐0.729]) and fimasartan (standardized mean difference ‐0.966 [‐1.21, ‐0.745]) showed the highest rank probabilities (37% and 35%) in the 4‐week group, considering the primary endpoint. Furthermore, the odds ratio of adverse events for all agents did not differ significantly from that of the placebo. The treatment rank of angiotensin II receptor blockers varied depending on the outcome type and follow‐up period considerably. Fimasartan rapidly lowered blood pressure in 4 weeks, which was further maintained until 12 weeks, indicating its competent efficacy and tolerability. Our findings may help medical practitioners and patients to select the best angiotensin II receptor blocker against hypertension.

Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions.

Iatrogeny due to drug-drug interactions is insufficiently documented, due to the high number of possible combinations. This study aimed to design a simple but general method to predict the variation of adverse events (AE) frequency due to a pharmacokinetic or pharmacodynamic interaction. Three prediction models were designed using a logistic probability density function. Each prediction model was based on three components: the AE odds ratio of each drug in the combination, and the area under the curve ratio (Rauc) of the pharmacokinetic interaction, if any. Pharmacodynamic interaction was assumed to be additive on logit scale. Rauc was predicted using a well-validated mechanistic static model, freely available online. No combination study is required. The method was evaluated against a wide range of AEs (28 High Level Terms) and 211 drug combinations (involving 43 victim drugs and 55 perpetrators), by comparing the observed and predicted frequencies. The observed odds ratios were estimated with a disproportionality analysis from the FDA Adverse Event Reporting System, using an approach that minimizes biases. With the best model, the rate of prediction considered as correct (within 50-200% of the observed value) was 72%, and the bias was negligible (-5%). The AE odds ratio due to pharmacokinetic and pharmacodynamic interactions was equally well predicted. A simple workflow to implement the method in practice is proposed. This method may help to foresee and to anticipate the harmful consequences associated with drug-drug interactions, at virtually no experimental cost, when the odds ratio of an AE is known for each drug alone and the AUC ratio is known or predicted by a suitable model.

Adverse Events of Soft Tissue Coagulation Using a Helium-Based Plasma Technology Alone and in Combination With Ultrasound-Assisted Liposuction.

BackgroundProtein denaturation and collagen contraction occur when living tissue is heated to well-defined temperatures. The result is reduced volume and surface area of the heated tissue.ObjectivesTo evaluate the adverse events of procedures in which a helium-based plasma technology (HPT) was used with and without ultrasound-assisted liposuction for the coagulation of soft tissue.MethodsA multicenter retrospective chart review was performed in which patients (n = 192) were divided into 2 groups: one that received only soft tissue coagulation and the other that received both soft tissue coagulation and liposuction. Each of the 2 groups was subdivided into patients with and without adverse events, including seroma. Odds ratios for adverse events were calculated for both demographic and surgical subgroups. Seroma data were analyzed separately.ResultsNo serious adverse events were observed. Forty-six (24.0%) patients reported 51 total adverse events. Seroma was the most frequently occurring adverse event with 13 patients (6.8%) reporting 17 (33.3%) events in 12 body areas. In these cases, all areas were treated with both liposuction and soft tissue coagulation. Seroma was not observed in patients receiving soft tissue coagulation alone. Patients aged 61 to 76 years and males were more likely to experience seroma or other adverse event than younger patients or females, respectively.ConclusionsThe use of the HPT for soft tissue coagulation in combination with ultrasound for liposuction is associated with nonserious adverse events. The most frequently occurring adverse event, seroma, was not observed in patients treated with HPT alone.Level of Evidence: 3

Nocebo-Prone Behavior Associated with SARS-CoV-2 Vaccine Hesitancy in Healthcare Workers.

Among healthcare workers (HCWs), SARS-CoV-2 vaccine hesitancy may be linked to a higher susceptibility to nocebo effects, i.e., adverse events (AEs) experienced after medical treatments due to negative expectations. To investigate this hypothesis a cross-sectional survey was performed with a self-completed questionnaire that included a tool (Q-No) for the identification of nocebo-prone individuals. A total of 1309 HCWs (67.2% women; 43.4% physicians; 28.4% nurses; 11.5% administrative staff; 16.6% other personnel) completed the questionnaires, among whom 237 (18.1%) had declined vaccination. Q-No scores were ≥15 in 325 participants (24.8%) suggesting nocebo-prone behavior. In a multivariate logistic regression model with Q-No score, age, gender, and occupation as independent variables, estimated odds ratios (ORs) of vaccination were 0.43 (i.e., less likely, p < 0.001) in participants with Q-No score ≥ 15 vs. Q-No score < 15, 0.58 in females vs. males (p = 0.013), and 4.7 (i.e., more likely) in physicians vs. other HCWs (p < 0.001), independent of age, which was not significantly associated with OR of vaccination. At least one adverse effect (AE) was reported by 67.5% of vaccinees, mostly local pain and flu-like symptoms. In a multivariate logistic regression model, with Q-No score, age, gender, and occupation as independent variables, estimated ORs of AE reporting were 2.0 in females vs. males (p < 0.001) and 1.47 in physicians vs. other HCWs (p = 0.017) independently of age and Q-No score, which were not significantly associated with OR of AE. These findings suggest that nocebo-prone behavior in HCWs is associated with SARS-CoV-2 vaccination hesitancy indicating a potential benefit of a campaign focused on nocebo-prone people.

Anlotinib for refractory advanced non-small-cell lung cancer: A systematic review and meta-analysis.

ObjectiveTo assess the efficacy and toxicity of anlotinib for the treatment of refractory advanced non-small-cell lung cancer (NSCLC).MethodsWe systematically searched databases for randomized controlled trials on anlotinib treatment for patients with advanced NSCLC published until November 6, 2020. Articles were assessed and data were extracted independently by two investigators. Further, we analyzed hazard ratios (HRs) for progression-free and overall survival (PFS and OS, respectively). In addition, we analyzed risk ratio (RR) for overall response and disease control rates (ORR and DCR, respectively) and the odds ratio (OR) for the main adverse events (AEs) using RevMan 5.3 software.ResultsThis analysis included 594 patients from three clinical studies. The pooled HRs for PFS and OS were 0.27 (95% confidence interval (CI): 0.22–0.33, P < 0.001) and 0.68 (95% CI: 0.56–0.83, P < 0.001), respectively, indicating that anlotinib administration significantly improved PFS and OS in patients with advanced NSCLC. The pooled RRs for ORR and DCR were 11.62 (95% CI: 2.75–49.14, P < 0.001) and 2.30 (95% CI: 1.91–2.77, P < 0.001), respectively, indicating that anlotinib administration in patients with advanced NSCLC improved ORR and DCR. The pooled OR for AEs of grade 3 or higher was 2.94 (95% CI: 1.99–4.35, P < 0.001), indicating that AEs of grade 3 or higher were more prevalent in the anlotinib group than in the placebo group.ConclusionAnlotinib, an effective choice of third- or later line therapy for patients with refractory advanced NSCLC, provides clinical benefits in terms of PFS, OS, ORR, and DCR. AEs associated with anlotinib were tolerable.

Safety of endoscopic gastrostomy tube placement compared with radiologic or surgical gastrostomy: nationwide inpatient assessment

A gastrostomy tube is often required for inpatients requiring long-term nutritional access. We compared the safety and outcomes of 3 techniques for performing a gastrostomy: percutaneous endoscopic gastrostomy (PEG), fluoroscopy-guided gastrostomy by an interventional radiologist (IR-gastrostomy), and open gastrostomy performed by a surgeon (surgical gastrostomy). Using the Nationwide Readmissions Database, we identified hospitalized patients who underwent a gastrostomy from 2016 to 2017. They were identified using the International Classification of Diseases, 10th Revision, Procedure Coding System. The selected patients were divided into 3 cohorts: PEG (0DH64UZ), IR-gastrostomy (0DH63UZ), and open surgical gastrostomy (0DH60UZ). Adjusted odds ratios for adverse events associated with each technique were calculated using multivariable logistic regression analysis. Of the 184,068 patients meeting the selection criteria, the route of gastrostomy tube placement was as follows: PEG, 16,384 (53.7 ± 29.0 years); IR-gastrostomy, 154,007 (67.2 ± 17.5 years); and surgical gastrostomy, 13,677 (57.9 ± 24.3 years). Compared with PEG, the odds for colon perforation using IR-gastrostomy and surgical gastrostomy, respectively, were 1.90 (95% confidence interval [CI], 1.26-2.86; P= .002) and 6.65 (95% CI, 4.38-10.12; P< .001), for infection of the gastrostomy 1.28 (95% CI, 1.07-1.53; P= .006) and 1.61 (95% CI, 1.29-2.01; P< .001), for hemorrhage requiring blood transfusion 1.84 (95% CI, 1.26-2.68; P= .002) and 1.09 (95% CI, .64-1.86; P= .746), for nonelective 30-day readmission 1.07 (95% CI, 1.03-1.12; P= .0023) and 1.13 (95% CI, 1.06-1.2; P= .0002), and for inpatient mortality 1.09 (95% CI, 1.02-1.17; P= .0114) and 1.55 (95% CI, 1.42-1.69; P< .0001). Placement of a gastrostomy tube (PEG) endoscopically is associated with a significantly lower risk of inpatient adverse events, mortality, and readmission rates compared with IR-gastrostomy and open surgical gastrostomy.

Clinical use of the STOP-BANG questionnaire to determine postoperative risk in veterans.

To determine whether STOP-BANG (snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference, gender) scores are associated with immediate postoperative adverse events in veterans undergoing surgery. In this prospective cohort study, veterans presenting to the presurgical clinic at a Veterans Affairs hospital answered the STOP-BANG questionnaire, which was scored as high risk (5-8), intermediate risk (3-4), and low risk (0-2) for obstructive sleep apnea (OSA), during a 6-month study period. Immediate postoperative respiratory and cardiovascular adverse events were recorded. The patient population included 1,080 veterans. Ninety-five patients (8.8%) experienced adverse events, of which 74 (6.9%) were respiratory and 21 (1.9%) were cardiovascular in nature. Patients with high-risk STOP-BANG scores (5-8) had significantly greater odds of having an adverse event odds ratio (OR) 2.1 (95% confidence interval [CI]: 1.4, 3.3) and hypoxia OR 2.8 (95% CI: 1.7, 4.6) compared to those with low- to intermediate-risk scores (0-4). Among patients with OSA, those with high-risk scores (5-8) had greater odds of an adverse event OR 3.9 (95% CI: 1.1, 13.9) and hypoxia OR 3.7 (95% CI: 1.1, 13.0) compared to those with low- to intermediate-risk scores (0-4). Patients without a history of OSA with high-risk scores (5-8) did not have significantly greater odds of an adverse event OR 1.5 (95% CI: 0.82, 2.6) or a hypoxic event OR 1.7 (95% CI: 0.87, 3.4) compared to those with low- to intermediate-risk scores (0-4). The STOP-BANG questionnaire was useful in the veteran population because high-risk scores were predictive of adverse events, in particular, hypoxia for patients with a previous diagnosis of OSA. In the future, this may direct studies and clinical activities aimed at optimizing safe and effective perioperative practices. 2b Laryngoscope, 129:259-264, 2019.

A New Feasible Syncope Risk Score Appropriate for Emergency Department: A Prospective Cohort Study.

We aimed to compare current syncope risk stratification scores and propose a new more feasible and easy-to-use one. In this prospective cohort study, we enrolled all patients (≥18 years) with chief complaint of syncope if they were not eligible for admission in terms of high-risk features. San Francisco Syncope Rule, Osservatorio Epidemiologico sulla Sincope nel Lazio, and risk stratification of syncope in the emergency department scores were compared in our population. Overall, 356 patients (mean age: 44.5 years, 46.3% male) were followed for 3 months. Serious adverse events occurred in 26 (7.3%) patients including 4 deaths. Odds ratio for adverse events was 6.8 [95% confidence interval (CI), 2.8-16.1; P < 0.001; area under the curve (AUC): 66.3], 7.7 (95% CI, 3.2-18; P < 0.001; AUC: 72.8), and 18 (95% CI, 7.1-45.4; P < 0.001; AUC: 70.8) when considering San Francisco Syncope Rule, Osservatorio Epidemiologico sulla Sincope nel Lazio, and risk stratification of syncope in the emergency department scores as the predicting tools, respectively. We proposed a relatively more feasible risk score (presenting symptoms, history of cardiovascular diseases, ejection fraction <50%, and predefined electrocardiography abnormalities). According to this syncope score, odds ratio for occurring adverse events was 20.9 (95% CI, 8.4-52; P < 0.001; AUC: 79.8). The 3 syncope risk scores could somehow predict 3-month adverse events. We found more feasible indicators that could predict serious events better. It suits well for emergency department.

Efficacy and Safety of Atypical Antipsychotics for Behavioral and Psychological Symptoms of Dementia Among Community Dwelling Adults

Introduction: Options for the treatment of the behavioral and psychological symptoms of dementia (BPSD) are limited. Atypical antipsychotics are often used but have questionable efficacy and are generally considered high risk. Therefore, the objective of this study is to evaluate the efficacy and safety of using any atypical antipsychotic for the treatment of BPSD among outpatients. Methods: Retrospective observational study of an academic outpatient memory disorders clinic. Participants included any community-dwelling patient with a diagnosis of dementia, not trauma induced, with documented BPSD treated with an atypical antipsychotic for at least 2 weeks. Medical records were reviewed from January 1, 1990 to March 23, 2010. Safety outcomes were documented from the time of antipsychotic initiation, and behavioral/psychological efficacy outcomes were documented beginning 2 weeks after antipsychotic therapy was initiated, until the last documentation available. Results: A total of 87 distinct antipsychotic treatment periods for 81 unique patients were included. Antipsychotic treatment was continued for more than a year in 33% of patients and only 17% of patients discontinued antipsychotic treatment over the entire period. The behavioral/psychological outcomes improved for 24 (28%) treatments, remained stable for 17 (20%) treatments, and worsened for 46 (53%) treatments. Adverse events were reported by 53% of patients, with the most common adverse events being metabolic, fall related, type, and vascular. Few adverse events were severe. The odds ratio of adverse events per every 90-day increase in duration of treatment was 1.20 (P = 0.02). Conclusion: Antipsychotic treatment improved behavioral/psychological symptoms for less than one-third of patients and increased the potential risk of adverse events for more than half of patients.

Do time of birth, unit volume, and staff seniority affect neonatal outcome in deliveries at ≥34+0 weeks of gestation?

We investigated whether time of birth, unit volume, and staff seniority affect neonatal outcome in neonates born at ≥34+0 weeks of gestation. Population-based prospective cohort study. Ten public hospitals in the Austrian province of Styria. A total of 87 065 neonates delivered in the period 2004-2015. Based on short-term outcome data, generalised linear mixed models were used to calculate the risk for adverse and severely adverse neonatal outcomes according to time of birth, unit volume, and staff seniority. Neonatal composite adverse and severely adverse outcome measures. The odds ratio for severely adverse events during the night-time (22:01-07:29 hours) compared with the daytime (07:30-15:00 hours) was 1.35 (95% confidence interval, 95% CI 1.13-1.61). There were no significant differences in neonatal outcome comparing weekdays and weekends, and comparing office hours and shifts. Units with 500-1000 deliveries per year had the lowest risk for adverse events. Adverse and severely adverse neonatal outcomes were least common for midwife-guided deliveries, and became more frequent with the level of experience of the doctors attending the delivery. With increasing pregnancy risks, senior staff attending delivery and delivering in a tertiary centre reduce the odds ratio for adverse events. Different times of delivery were associated with increased adverse neonatal outcomes. The management of uncomplicated deliveries by less experienced staff showed no negative impact on perinatal outcome. In contrast, riskier pregnancies delivered by senior staff in a tertiary centre favour a better outcome. Achieving a better balance in the total number of labour ward staff during the day and the night appears to be a greater priority than increasing the continuous presence of senior obstetrical staff on the labour ward during the out-of-hours period. Deliveries during night time lead to a greater number of neonates experiencing severely adverse events.

Preeclampsia in pregnancies complicated by systemic lupus erythematosus (SLE) nephritis: prophylactic treatment with multidisciplinary approach are important keys to prevent adverse obstetric outcomes

Introduction: Systemic lupus erythematosus (SLE) commonly affects women of childbearing age. Hypertension, antiphospholipid syndrome, and lupus nephritis are risk factors for adverse maternal/fetal outcome. The aim of this retrospective cohort study is to compare pregnancy outcomes in patients with and without SLE nephritis, using a multidisciplinary approach and a broad prophylaxis protocol.Materials and methods: Data were collected from 86 pregnancies complicated by SLE. Twenty-seven women with nephropathy before pregnancy stated as the study group and 59 formed the control group. Each group received a prophylactic treatment based on their clinical characteristics. Results were expressed as mean ± SD, percentage and χ2-test (significant values when p < .05).Results: The prophylactic treatment (60.4% of the patients) significantly controlled the complications related to some risk factors, such as antiphospholipid antibodies (aPL) and nephritis. Preeclampsia occurred in 14.8% of patients. Patients with pregestational hypertension showed a 2.75 odds ratio of adverse events when compared to the group without chronic hypertension. The presence of proteinuria was associated with a risk of preeclampsia 2.45 times greater, as well as serum creatinine >1.2 mg/dL, which was related to a risk 1.25 times higher than the risk observed in patients with serum creatinine <1.2 mg/dL. A 6-month inactive disease was associated with a better outcome. A value of Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73 m2 resulted in a 18.73 times greater risk of preeclampsia, intrauterine growth restriction (IUGR), and preterm delivery.Discussion: A multidisciplinary approach in a tertiary care center and a broad prophylactic treatment protocol to patients affected by SLE and complicated by nephritis may definitively foster a successful pregnancy.

Ustekinumab Does Not Increase Risk of Serious Adverse Events: A Meta-Analysis of Randomized Controlled Trials

Introduction: Inflammatory bowel disease (IBD) therapy is continuously evolving with novel drugs targeting various inflammatory pathways. Ustekinumab (USK), a monoclonal antibody inhibiting the IL-12/23 pathway, was approved in September 2016 to treat moderate-to-severe Crohn's disease (CD). While safety data in IBD is limited, USK has been used to treat other autoimmune diseases with favorable safety profiles. We aimed to establish rates of adverse events (AE) and demonstrate non-inferiority of AE of USK compared to placebo and other biologics. Methods: MEDLINE, PubMed and Embase databases were searched in May 2017 using terms “ustekinumab” and “clinical trials.” Two authors independently performed quality assessment and dual extraction. Randomized control trials comparing USK to placebo or other biologics regardless of disease were included. The primary outcome was the odds ratio (OR) of AE of USK vs placebo, expressed as pooled OR and 95% confidence interval (CI). Secondary outcomes included OR of mild/moderate and serious AE (SAE) in USK vs placebo, USK vs biologics, and low vs high-dose USK, respectively (Table 2). A sub-analysis of outcomes in CD trials was performed. Random effects meta-analysis was performed for all outcomes.Table: Table. Odds ratio for Adverse Events in USK groupResults: 16 papers with 6756 subjects (44% female) were included (Fig 1). Infections were the most common AE (Table 1). The OR of serious AE in USK vs placebo was 0.76 (95% CI 0.56-1.03, Fig 2). The OR of mild-to-moderate AE in the USK vs placebo was 1.12 (95% CI 1.01-1.24), suggesting increased risk of mild/moderate AE with USK (Fig 3). However, this was no longer significant after sub-analysis of the three CD trials. Analysis of 5 trials comparing low vs high-dose USK revealed an OR of 0.96 (95% CI 0.46-2.04) for SAE and 1.17 (95% CI 0.98-1.39) for mild-to-moderate AE. Use of USK was not associated with increased AE compared to other biologics, with OR of 0.91 (95% CI 0.61-1.35) for SAE and 0.98 (95% CI 0.85-1.13) for mild/moderate AE. Heterogeneity was low for all calculations.Figure: Prisma diagram for study identification and inclusion.Figure: Forest Plot of Serious Adverse Events, Ustekinumab vs Placebo.Figure: Forest Plot of Mild/Moderate Adverse Events, Ustekinumab vs Placebo.Table: Table. Rates of Adverse EventsConclusion: USK has a comparable safety profile to placebo and other biologics in the treatment of various diseases, although we did find a mildly elevated risk of mild/moderate AE with USK; however, this was not seen in CD trials. The favorable safety profile of USK is of clinical importance with the advent of USK in CD and ongoing clinical trials for ulcerative colitis. More data on long-term safety data in the IBD population is needed.

Comparative Efficacy And Safety Of Olaparib 300 Mg Tablets Bid And Niraparib 300 Mg Tablets QD As Maintenance Treatment After Response To Chemotherapy In Patients With Platinum-Sensitive Relapsed Germline BRCA-Mutated Ovarian Cancer (PSROC)

Maintenance therapy with a poly(ADP-ribose) polymerase inhibitor (PARPi), following response to platinum-based chemotherapy, significantly extends progression-free survival (PFS) and time to first subsequent treatment or death (TFST) in gBRCAm PSROC. The comparative efficacy and safety of different PARPis is currently unknown. An indirect treatment comparison (ITC) analysis of data from the ENGOT-OV16/NOVA and ENGOT-OV21/SOLO2 clinical studies was used to compare niraparib tablets with olaparib tablets. A Bayesian ITC was performed on efficacy and safety data from NOVA (niraparib) and SOLO2 (olaparib). Efficacy data for gBRCAm patients in NOVA were compared with SOLO2. Efficacy analyses included comparing the hazard ratios (HR) of PFS, of investigator-assessed PFS (primary) and independent review committee (IRC)-assessed PFS of SOLO2 versus NOVA, and HR of TFST. Safety analyses included the odds ratio (OR) of any grade ≥3 adverse event (AE), and AEs leading to discontinuation, dose interruption, or dose reduction. PFS HRs comparing olaparib and niraparib were 1.11 (95% credible interval 0.67–1.83) for investigator-assessed PFS, and 0.93 (0.53–1.61) for IRC PFS. TFST HR was 0.90 (0.54–1.49). No significant difference in efficacy between PARPi was observed. The corresponding OR for AEs was 0.18 (0.07–0.47), 0.30 (0.11–0.79), 0.49 (0.01–6.91) and 0.13 (0.02–0.85) for any grade ≥3 AEs, AEs leading to dose interruption, discontinuation, or reduction, respectively. There was a significant reduction in the odds of any grade ≥3 AE and AEs leading to interruption or dose reduction with olaparib, compared with niraparib. ITC shows no significant difference in efficacy between olaparib tablets and niraparib tablets as maintenance therapy in patients with gBRCAm PSROC, following response to chemotherapy. Olaparib is predicted to have had a superior safety profile versus niraparib, with reduced odds of grade ≥3 AEs, drug interruption, and dose reduction.

MP22-04 URETEROSCOPY FOR URETERAL STONES: A MULTIVARIATE ANALYSIS OF ADVERSE EVENTS

You have accessJournal of UrologyStone Disease: Surgical Therapy I1 Apr 2016MP22-04 URETEROSCOPY FOR URETERAL STONES: A MULTIVARIATE ANALYSIS OF ADVERSE EVENTS Carrie Yeast, Woodson Smelser, Jack Campbell, Derek Benham, Chelsea Deroche, and James Cummings Carrie YeastCarrie Yeast More articles by this author , Woodson SmelserWoodson Smelser More articles by this author , Jack CampbellJack Campbell More articles by this author , Derek BenhamDerek Benham More articles by this author , Chelsea DerocheChelsea Deroche More articles by this author , and James CummingsJames Cummings More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.692AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES With advances in fiberoptic, digital imaging, and fragmentation/retrieval technology, ureteroscopy is increasingly utilized for the management of urolithiasis. Several studies have attempted to characterize the post-operative complication and readmission rates relative to the technical difficulty of the procedure. We review our experience with ureteroscopy for ureteral stones to create a model to predict what factors, including resident experience, affect rates of post-operative complications. METHODS We reviewed ureteroscopies performed at our academic tertiary care facility from January 2009 to December 2013. Cases of ureteroscopy for ureteral-only stones were examined for demographics, history of previous stones, stone size and location, operative techniques utilized and resident training level. All post-operative adverse events requiring urology consultation, clinic or emergency department visits, hospital admission, prolonged post-operative hospitalization, or repeat surgery within 30 days of the procedure were identified and analyzed. RESULTS From 1120 procedures initially identified, 417 cases of ureteroscopy for ureter-only stones were included for study. We identified 53 (12.7%) involving an unexpected post-operative course. Of these, 29 (6.9%) involved return to emergency department, 25 (6%) required readmission, 12 (2.88%) required repeat operative intervention under anesthesia with the most common procedure being repeat ureteroscopy for additional stone burden, followed by stent placement. Logistic regression was performed to create a predictive model of adverse events with residency year, stone clearance, stone location, and stone size as predictor variables. While controlling for all other variables, only lack of stone clearance was significant for increasing the likelihood of an adverse event. A second logistic model was performed to determine the odds ratio of adverse events with stone clearance and residency year as predictor variables. In this group, while controlling for stone clearance, no residency year showed higher odds of adverse outcomes. CONCLUSIONS Ureteroscopy has increased in prevalence in recent years, but overall complication rates are low. Resident level of experience does not appear to impact adverse event rate. Stone clearance during initial surgery appears to be most important in avoiding adverse events. Due to a low level of overall adverse events, not all variables were able to be included in analysis. Further expansion of the database over time will improve our ability to predict adverse outcomes in this common procedure. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e254 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Carrie Yeast More articles by this author Woodson Smelser More articles by this author Jack Campbell More articles by this author Derek Benham More articles by this author Chelsea Deroche More articles by this author James Cummings More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A large-scale survey of adverse events experienced in yoga classes.

BackgroundYoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.MethodsThe subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.ResultsAmong 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.ConclusionsThe results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.