Higher Risk Of Adverse Events Research Articles

Sit to stand muscle power reference values and their association with adverse events in Colombian older adults

Recently, a valid method to assess lower-body muscle power based on a sit-to-stand field test (STS) has been published. Our study aimed to describe lower-body muscle power in older individuals aged ≥ 60 years and examine the relationship of muscle weakness with adverse events according to gender- and age-specific muscle weakness cut-off points. A total of 3689 Colombian older adults (57.6% women, age 69.1 ± 6.9 years) from the 2015 Survey on Health, Well-Being, and Aging in Latin America and the Caribbean (SABE) participated in this study. Lower-body muscle power normalized to body mass was estimated by the five-repetitions STS test. Anthropometric, physical performance and clinical characteristics were collected. Age-specific percentiles using the LMS method, cut-off points and association with adverse events were calculated. Lower-body muscle power was greater in men than among women (2.2 ± 0.7 vs. 1.6 ± 0.5 W·kg−1, respectively; p < 0.001) at all ages. Muscle power ranked in the 50th percentile between 2.38 and 1.30 W·kg−1 in men, whereas women ranked between 1.79 and 1.21 W·kg−1. According to the cut-off points, lower-limb muscle power < 1 standard deviation in men was associated with having dynapenia, poor gait speed, cognitive impairment and mental, visual, hearing and memory problems. While, women were associated with having sarcopenia, dynapenia, poor gait speed, cognitive impairment, mental, hearing and memory problems, dementia and hospitalizations of > 24 h in the last year. Overall, participants with poor lower-limb muscle power had a significantly higher risk of adverse events [in men: odds ratio (OR) = 1.51, 95% confidence interval (CI) = 1.19–1.91, p < 0.001; in women: OR = 1.52, 95% CI = 1.27–1.87, p = 0.001] than their stronger counterparts. This study is the first to describe lower-limb muscle power values and cut-off points among a nationally representative sample of Colombian older adults. In men, 7 of the 14 adverse events studied were associated with lower muscle strength, whereas in women, it was 9 of the 14 adverse events.

Directly Measured vs. Calculated Low-Density Lipoprotein Cholesterol Does Not Identify Additional Individuals With Coronary Artery Disease and Diabetes at Higher Risk of Adverse Events: Insight From a Large Percutaneous Coronary Intervention Cohort in Asia.

BackgroundThe objective of our study was to assess whether calculated low-density lipoprotein cholesterol (LDL-C) is inferior to direct LDL-C (dLDL-C) in identifying patients at higher risk of all-cause mortality, recurrent acute myocardial infarction (AMI), and major adverse cardiovascular event (MACE).MethodsA total of 9,751 patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) in the Fuwai PCI registry were included. DLDL-C was measured by the selective solubilization method (Kyowa Medex, Tokyo, Japan). Correct classification was defined as the proportion of estimated LDL-C in the same category as dLDL-C based on dLDL-C levels: less than 1.4, 1.4–1.8, 1.8–2.6, 2.6–3.0, and 3.0 mmol/L or greater.ResultsUnderestimation of LDL-C was found in 9.7% of patients using the Martin/Hopkins equation, compared with 13.9% using the Sampson equation and 24.6% with the Friedewald equation. Cox regression analysis showed compared the correct estimation group, underestimation of LDL-C by the Martin/Hopkins equation did not reduce all-cause mortality (HR 1.26, 95% CI: 0.72–2.20, P = 0.4), recurrent AMI (HR 1.24, 95% CI: 0.69–2.21, P = 0.5), and MACE (HR 1.02, 95% CI: 0.83–1.26, P = 0.9). Similarly, the overestimated group did not exacerbate all-cause mortality (HR 0.9, 95% CI: 0.45–1.77, P = 0.8), recurrent AMI (HR 0.63, 95% CI: 0.28–1.44, P = 0.3), and MACE (HR 1.07, 95% CI: 0.86–1.32, P = 0.6). The results of the diabetes subgroup analysis were similar to those of the whole population.ConclusionCompared with dLDL-C measurement, misclassification by the Martin/Hopkins and Sampson equations was present in approximately 20% of patients. However, directly measured vs. calculated LDL-C did not identify any more individuals in the PCI population with increased risk of all-cause mortality, recurrent AMI, and MACE, even in high-risk patients such as those with diabetes.

A National Retrospective Study of Antidepressants' Effects on Overdose and Self-Harm Among Adults Treated With Opioid Analgesics.

Because individuals with a history of depression who are receiving opioids are at higher risk for adverse events, the authors examined whether antidepressant treatment reduces risk for overdose and self-harm among individuals with a history of depression who receive opioids. Commercial insurance claims of individuals with a history of depression receiving opioids from 2007 to 2017 were used to quantify the association between antidepressant fills and adverse events among individuals after initiation of opioid treatment; the authors accounted for selection into treatment and used discrete-time, proportional hazards survival models. Among 283,374 adults with a history of depression treatment, 8,203 experienced 47,486 adverse events from 2007 to 2017 in the 12 months after initiation of opioid treatment. Approximately half (N=144,052, 50.8%) filled an antidepressant prescription at least once in the 12 months after the opioid episode began. Individuals receiving antidepressants for at least 6 weeks had a reduced risk for any adverse event (adjusted odds ratio [AOR]=0.79, 95% confidence interval [CI]=0.65-0.97) as well as a reduced risk for opioid overdoses (AOR=0.78, 95% CI=0.64-0.96), overdoses from nonopioid controlled substances (AOR=0.76, 95% CI=0.62-0.94), overdoses from other substances (AOR=0.79, 95% CI=0.65-0.97), and other self-harm events (AOR=0.82, 95% CI=0.67-1.00). Individuals with a history of depression who received opioid analgesics had a significantly lower risk for overdose and self-harm after they had been taking antidepressants for at least 6 weeks. Universal screening for mood disorders among individuals receiving opioids, and promptly providing evidence-based depression treatment when appropriate, may reduce adverse events.

Significance of Left Ventricular Ejection Time in Primary Mitral Regurgitation

The optimal timing for mitral valve (MV) surgery in asymptomatic patients with primary mitral regurgitation (MR) remains controversial. We aimed at evaluating the relation between left ventricular ejection time (LVET) and outcome in patients with moderate or severe chronic primary MR because of prolapse. Clinical, Doppler echocardiographic, and outcome data prospectively collected from 302 patients (median age 61 [54 to 74] years, 34% women) with moderate or severe primary MR were analyzed. Patients were retrospectively stratified by quartiles of LVET. The primary end point of the study was the composite of need for MV surgery or all-cause mortality. During a median follow-up time of 66 (25th to 75th percentile, 33 to 95) months, 178 patients reached the primary end point. Patients in the lowest quartile of LVET (&lt;260 ms) were at high risk for adverse events compared with those in the other quartiles of LVET (global p=0.005), whereas the rate of events was similar for the other quartiles (p=NS for all). After adjustment for clinical predictors of outcome, including age, gender, history of atrial fibrillation, MR severity, and current recommended triggers for MV surgery in asymptomatic primary MR, LVET &lt;260 ms was associated with an increased risk of events (adjusted hazard ratio 1.49, 95% confidence interval 1.03 to 2.16, p=0.033). In conclusion, we observed that shorter LVET is associated with increased risk of adverse events in patients with moderate or severe primary MR because of prolapse. Further studies are required to investigate whether shorter LVET has a direct effect on outcomes or is solely a risk marker in primary MR.

Optical coherence tomography-derived lipid core burden index and clinical outcomes: results from the CLIMA registry.

The aim of this study was to assess the morphological characteristics and prognostic implications of the optical coherence tomography (OCT)-derived lipid core burden index (LCBI). OCT-LCBI was assessed in 1003 patients with 1-year follow-up from the CLIMA multicentre registry using a validated software able to automatically obtain a maximum OCT-LCBI in 4 mm (maxOCT-LCBI4mm). Primary composite clinical endpoint included cardiac death, myocardial infarction, and target-vessel revascularization. A secondary analysis using clinical outcomes of CLIMA study was performed. Patients with a maxOCT-LCBI4mm ≥ 400 showed higher prevalence of fibrous cap thickness (FCT) <75 μm [odds ratio (OR) 1.43, 95% confidence interval (CI) 1.03-1.99; P = 0.034], lipid pool arc >180° (OR 3.93, 95%CI 2.97-5.21; P < 0.001), minimum lumen area <3.5 mm2 (OR 1.5, 95%CI 1.16-1.94; P = 0.002), macrophage infiltration (OR 2.38, 95%CI 1.81-3.13; P < 0.001), and intra-plaque intimal vasculature (OR 1.34, 95%CI 1.05-1.72; P = 0.021). A maxOCT-LCBI4mm ≥400 predicted the primary endpoint [adjusted hazard ratio (HR) 1.86, 95%CI 1.1-3.2; P = 0.019] as well as the CLIMA endpoint (HR 2.56, 95%CI 1.24-5.29; P = 0.011). Patients with high lipid content and thin FCT < 75 µm were at higher risk for adverse events (HR 4.88, 95%CI 2.44-9.72; P < 0.001). A high maxOCT-LCBI4mm was related to poor outcome and vulnerable plaque features. This study represents a step further in the automated assessment of the coronary plaque risk profile.

Adverse events after different forms of botulinum neurotoxin A injections in children with cerebral palsy: An 8-year retrospective study.

To compare the risks of adverse events 3 months after Onabotulinumtoxin-A and Lanbotulinumtoxin-A injections in children with cerebral palsy (CP) and to identify risk factors and associations. A total of 1037 children (682 males, 355 females; mean age 5 years 2 months [SD 3 years]; age range 2 years-17 years 10 months) with CP underwent 1013 Onabotulinumtoxin-A injections and 418 Lanbotulinumtoxin-A injections from 2012 to 2021. Information was recorded in a purpose-built database. The adverse event rates of Onabotulinumtoxin-A and Lanbotulinumtoxin-A were reported as 13.92% and 11.96% respectively. Most adverse events were mild and self-limiting. Children in Gross Motor Function Classification System (GMFCS) levels IV to V had a higher risk of adverse events than those in GMFCS levels I to III (odds ratio [OR] [95% confidence interval {CI}]=3.65 [1.56, 5.40], p < 0.01). The history of recent illness and higher dose increased the likelihood of adverse events (OR [95% CI]=2.00 [1.55, 3.00] and 2.20 [1.53, 3.07] respectively, p < 0.01). Sex, age, and the number of injections had no significant effect on adverse event rates (p > 0.05). The incidence of upper respiratory tract infection and lower respiratory tract infection after injections was weakly correlated with the incidence before injections (r=0.36 and r=0.27 respectively, p < 0.01). Occurrence of adverse events was similar between Onabotulinumtoxin-A and Lanbotulinumtoxin-A in children with CP. Dose, GMFCS level, and health background were risk factors. The prevalence of adverse events was similar between Onabotulinumtoxin-A and Lanbotulinumtoxin-A in children with cerebral palsy (CP). The prevalence of adverse events increased with the severity of CP and the injected dose. Sex, age, and number of injections had no significant effect on the prevalence of adverse events.

Efficacy of Topical Intervention for Recurrent Aphthous Stomatitis: A Network Meta-Analysis.

Background and objectives: To compare the efficacy and safety of topical interventions used for recurrent aphthous stomatitis. Materials and Methods: This network meta-analysis was conducted in accordance with the PRISMA statement. We searched four electronic databases, PubMed, Web of Science (WOS), Cochrane Central Register of Controlled Trials and Embase, for randomized controlled trials reporting efficacy and safety data on topical interventions for recurrent aphthous stomatitis. We performed a quality evaluation using a methodology based on the Cochrane Handbook. Two authors independently extracted data on healing effect, size reduction effect, symptom reduction effect, recurrence and safety assessment. Network meta-analysis was then performed using ADDIS and RevMan. Results: A total of 72 trials (5272 subjects) involving 29 topical interventions were included. Honey, lnsulin liposome gel, laser, amlexanox, glycyrrhiza and triamcinolone had better efficacy performance. Probiotics and chlorhexidine helped to prolong ulcer intervals and reduce recurrence. Doxycycline and penicillin had a high risk of adverse events. Hematologic evaluation showed no preference. The rank possibility of size-reducing effect and symptom-reducing effect supported the short-term effect of laser and the long-term effect of probiotics. Conclusions: We recommend the use of laser as a short-term intervention during the exacerbation phase of RAS and probiotics as a long-term intervention during the exacerbation and remission phases of RAS.

Prognostic Impact of Blood Pressure Change Patterns on Patients With Aortic Dissection After Admission.

ObjectivesHypertension is a predominant risk factor for aortic dissection (AD), and blood pressure (BP) control plays a vital role in the management of AD. However, the correlation between BP change and the prognosis for AD remains unclear. This study aims to demonstrate the impact of BP change patterns on AD prognosis.MethodsThis retrospective study included AD patients at two institutions (Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine and the Vascular Department of the First Affiliated Hospital of Anhui Medical University) between 2004 and 2018. The systolic BP (SBP) change patterns of these patients were analyzed by functional data analysis (FDA). The relationship between BP change patterns and the risk of adverse events (AEs) was assessed using survival analysis.ResultsA total of 458 patients with AD were eligible for analysis. The logistic regression analysis indicated that compared with that in patients with low SBP variation (SBPV), the incidence of AEs in patients with high SBPV was significantly higher (35.84 vs. 20.35%, OR 2.19, P < 0.001). The patients were divided into four categories (accelerating rise, accelerating drop, decelerating rise, and decelerating drop) based on their SBP patterns after FDA fitting. The results of Kaplan–Meier analysis showed that at the 15- and 20-min time points, the incidence of AEs in the decelerating-drop group was significantly lower than that in the accelerating-rise group (OR 0.19, P = 0.031 and OR 0.23, P = 0.050). However, at the 25- and 30-min time points, the difference between these four groups was not significant (OR 0.26, P = 0.08 and OR 0.29, P = 0.10).ConclusionsThis study classified AD patients into four groups according to the SBP change patterns the first 30 min following admission, of which those with accelerating rises in SBP are at the highest risk of AEs, while those with decelerating drops have the best prognosis in the first 24 h after admission. Clinical practitioners may benefit from analyzing patterns of in-hospital SBP.

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis.

Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

Influence of albumin and methotrexate clearance on high-dose methotrexate-induced mucositis.

e15081 Background: Methotrexate (MTX) is a cornerstone of therapy for several types of cancer. HDMTX-induced mucositis can impact quality of life and delay subsequent chemotherapy. Objective: The objective of this study was to understand the factors increasing risk for mucositis in patients receiving HDMTX in a multicenter cohort. Methods: A multi-center retrospective study collected data on pediatric and young adult patients ages 0-32 years at diagnosis who received at least one dose of HDMTX (&gt;500 mg/m2) at Children’s Healthcare of Atlanta or Cincinnati Children’s Hospital Medical Center from January 2010 through December 2020. Demographic and clinical variables were manually abstracted, while medications and lab values were electronically pulled from the electronic medical record. Common Terminology Criteria for Adverse Events v5 was used to identify the presence and grade of mucositis after HDMTX administration. Institutional review board approval was obtained at each site. Chi-square and t-tests, as appropriate, were calculated using GraphPad Prism v9. MTX concentrations were fit to a published pharmacokinetic model to estimate clearance using NONMEM. Results: The cohort is described in Table. The rate of mucositis was highest after the first HDMTX administration (54.6%), when the MTX clearance is slowest (30.1%&lt;10 L/hr/1.73m2 and albumin was lowest (14.3%&lt;2.5g/dL). Mucositis was significantly more likely in patients with hypoalbuminemia and in patients with MTX clearance &lt;10 L/hr/1.73m2 (OR 1.75 (CI: 1.503 to 2.028), p&lt;0.0001 and OR 1.43 (CI: 1.236 to 1.653), p&lt;0.0001, respectively). Conclusions: Mucositis after administration of HDMTX is common, with 72% of patients experiencing at least grade 1 mucositis and a third of HDMTX administrations leading to mucositis. Chart abstraction is ongoing at a third hospital to increase the sample size, particularly those of Hispanic/Latino ethnicity, in order to investigate differences by race and ethnicity. In addition, current analyses are evaluating the impact of changes in supportive care on HDMTX-induced mucositis and other adverse events. The results of this study will demonstrate who is at highest risk for adverse events so supportive care can be tailored during this potentially toxic chemotherapy.[Table: see text]

Treating advanced lung cancer in older Veterans with comorbid conditions and frailty

Advanced lung cancer is a deadly malignancy that is a common cause of death among Veterans. Significant advancements in lung cancer therapeutics have been made over the past decade and survival outcomes have improved. The Veteran population is older, has more medical comorbidities and frailty compared to the general population. These factors must be accounted for when evaluating patients for treatment and selecting treatment options. This article explores the impact of these important issues in the management of advanced lung cancer. Recent clinical trials leading to the approval of modern therapies will be outlined and treatment outcomes specific to older patients discussed. The impact of key comorbidities that are common in Veterans and their impact on lung cancer treatment will be reviewed. There is no gold standard frailty index for assessment of frailty in patients with advanced lung cancer and the ability to predict tolerability and benefit from systemic therapies. Currently available systemic therapies are associated with higher risk of adverse events and lower potential for clinically meaningful improvement in outcomes. Future research needs to focus on designing better frailty indices and developing novel therapies that are safer and more effective therapies for frail patients, who constitute a considerable proportion of individuals diagnosed with lung cancer.

Development of a remote monitoring program for melanoma/skin oncology patients at Princess Margaret Cancer Centre.

e18630 Background: The Melanoma/Skin Oncology (MSO) clinic supports &gt; 200 patients on active treatment at any given time. In September 2018, the MSO clinic implemented a nurse-led proactive management program (IMBRASE) to support the monitoring of adverse events (AEs) in patients receiving immunotherapy (IO). Nurses conducted telephone calls at a pre-determined frequency to identify those who required immediate in-person assessment. Despite an initial 40% drop in emergency department visits in the first few months of implementation, insufficient human resources and lack of prioritization of assessments impacted the clinic’s ability to sustain this program. We sought to overcome this limitation by employing digital health technology to monitor and triage on-treatment patients for assessment (eIMBRASE program). Methods: MSO team worked alongside an internal innovation team (Cancer Digital Intelligence) to develop a remote assessment program with an algorithm able to prioritize patients by combining real-time biometrics and automatically scheduled electronic patient-reported outcomes (ePROs) data of individuals undergoing targeted-therapy and IO. This new digital tool will be accessible via smartphone/computer. It will enable patients to send their data to the clinical team and establish priorities based on patients’ complexity of symptoms. Results: eIMBRASE algorithm requires four data points to be displayed for the clinical team: overall priority, cumulative score (CS), biometric alert, and no response alert. The first two points are based on ePROs, for which we established a set of symptoms of interest for each treatment modality. Each symptom can be categorized in 1 of the 6 priority levels. Each priority is associated with a number of complexity points on a logarithmic scale from 0 - 400. After a questionnaire is submitted, a CS is generated for clinicians to determine which patient may be the most complex and deserve priority assessment. Regarding the third data point, oxygen saturation (SpO2) and temperature (T) measures are collected throughout the day and patients are flagged according to the following predefined thresholds: T - red alert &gt; 38.5C, orange 38.1-38.4C, yellow 37.5-38C; and SpO2 - red alert £93%. Patients under the highest risk of AEs, for instance those on anti-CTLA4 + anti-PD1, are required to complete ePROs daily during the first 12 weeks. Patients under low-risk therapies are required to complete ePROs 1x/week. The tool triggers priority-oriented timeframe for medical contact. To minimize the influence of poor electronic literacy, patients will have their apps set up at clinic before treatment initiation. Conclusions: eIMBRASE development presents an alternative way to use digital health tools to potentially improve quality of care for MSO patients. A pilot study will be conducted to assess its feasibility, the impact in patients’ outcomes and satisfaction.

Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States

It is known that hospitalized patients who experience adverse events are at greater risk of readmission; however, it is unknown whether patients admitted to hospitals with higher risk-standardized readmission rates had a higher risk of in-hospital adverse events. To evaluate whether patients with pneumonia admitted to hospitals with higher risk-standardized readmission rates had a higher risk of adverse events. This cross-sectional study linked patient-level adverse events data from the Medicare Patient Safety Monitoring System (MPSMS), a randomly selected medical record abstracted database, to the hospital-level pneumonia-specific all-cause readmissions data from the Centers for Medicare & Medicaid Services. Patients with pneumonia discharged from July 1, 2010, through December 31, 2019, in the MPSMS data were included. Hospital performance on readmissions was determined by the risk-standardized 30-day all-cause readmission rate. Mixed-effects models were used to examine the association between adverse events and hospital performance on readmissions, adjusted for patient and hospital characteristics. Analysis was completed from October 2019 through July 2020 for data from 2010 to 2017 and from March through April 2022 for data from 2018 to 2019. Patients hospitalized for pneumonia. Adverse events were measured by the rate of occurrence of hospital-acquired events and the number of events per 1000 discharges. The sample included 46 047 patients with pneumonia, with a median (IQR) age of 71 (58-82) years, with 23 943 (52.0%) women, 5305 (11.5%) Black individuals, 37 763 (82.0%) White individuals, and 2979 (6.5%) individuals identifying as another race, across 2590 hospitals. The median hospital-specific risk-standardized readmission rate was 17.0% (95% CI, 16.3%-17.7%), the occurrence rate of adverse events was 2.6% (95% CI, 2.54%-2.65%), and the number of adverse events per 1000 discharges was 157.3 (95% CI, 152.3-162.5). An increase by 1 IQR in the readmission rate was associated with a relative 13% higher patient risk of adverse events (adjusted odds ratio, 1.13; 95% CI, 1.08-1.17) and 5.0 (95% CI, 2.8-7.2) more adverse events per 1000 discharges at the patient and hospital levels, respectively. Patients with pneumonia admitted to hospitals with high all-cause readmission rates were more likely to develop adverse events during the index hospitalization. This finding strengthens the evidence that readmission rates reflect the quality of hospital care for pneumonia.

Adverse Cardiovascular Effects of Anti-tumor Therapies in Patients With Breast Cancer: A Single-center Cross-sectional Analysis.

Cardiotoxicity due to antitumor therapy is a dreaded complication and could thus impact the prognosis of patients with breast cancer. This study sought to analyze the occurrence of adverse cardiovascular events and to identify potential risk factors. A total of 136 patients with breast cancer were divided into two groups based on the occurrence of treatment-related cardiovascular toxicity [event 47 (35%) vs. no event 89 (65%)]. Patients were followed over a median of 45 months (range=37-83 months). Most common events were thromboembolic complications (26%), followed by heart failure (15%) and acute toxic cardiomyopathy (5%), with a reduced left ventricular ejection fraction [LVEF (%), no event 59±5.0 vs. event 55±11, p=0.01 ]. Patients with leftsided breast cancer and an advanced stage disease had a higher risk of developing adverse cardiovascular events. The highest risk was found for patients with a high number of cardiovascular risk factors. In addition to LVEF, mitral annular plane systolic excursion was also significantly reduced in the event group, while there was a trend for higher global longitudinal strain. During follow-up, 26 patients (19.1%) deceased, whereof 12 had a treatment-related cardiovascular event, but without statistical difference. Treatment-related cardiovascular events are relatively common in about one third of patients with breast cancer. Women with a cardiovascular risk profile or an advanced stage disease had a higher risk for adverse events. Despite the treatment-related cardiac deterioration, no difference in mortality was observed during follow up.

Survey on Use of Local and Systemic Corticosteroids in the Management of Chronic Rhinosinusitis with Nasal Polyps: Identification of Unmet Clinical Needs.

Background: Local and systemic corticosteroids have long been the workhorse in management of chronic rhinosinusitis with nasal polyps (CRSwNP), although there is no universally accepted modality of prescription. We carried out a survey in Italy to capture current trends in the use of topical and systemic corticosteroids in patients with CRSwNP. Methods: A survey was set up on Survey Monkey®. Each author distributed the link to the survey in an ad hoc manner and a total of 437 participants filled out the survey. Results: Mometasone furoate (79.3%) was the most frequently prescribed, administered daily by 61.9% of participants; the remaining preferred to discontinue treatment for brief periods to reduce side effects or to modulate the therapy in mild cases. The majority believe that a short cycle of systemic steroids should be prescribed for re-exacerbation of symptoms and that the number of cycles in the previous year should be evaluated to define control of the disease even if international guidelines do not provide clear indications on this topic. A certain degree of divergence emerged from responses regarding how long and the maximal dose of systemic steroids which place patients at high risk for adverse events. Finally, systemic corticosteroids seem to offer only temporary benefit on recovery of smell without guaranteeing long-term control even if the patient is adherent to topical corticosteroids. Conclusions: Our results highlight the need for clear guidelines on oral steroids, which could help supporting the use of a precision medicine approach, including indications for new biological agents.

Comparative efficacy and safety of adenosine and regadenoson for assessment of fractional flow reserve: A systematic review and meta-analysis.

BACKGROUNDAdenosine is a coronary hyperemic agent used to measure invasive fractional flow reserve (FFR) of intermediate severity coronary stenosis.AIMTo compare FFR assessment using adenosine with an alternate hyperemic agent, regadenoson.METHODSPubMed, Google Scholar, CINAHL and Cochrane databases were queried for studies comparing adenosine and regadenoson for assessment of FFR. Data on FFR, correlation coefficient and adverse events from the selected studies were extracted and analyzed by means of random effects model. Two tailed P-value less than 0.05 was considered significant. Heterogeneity was assessed using I2 test.RESULTSFive studies with 248 patients were included in the final analysis. All included patients and coronary lesions underwent FFR assessment using both adenosine and regadenoson. There was no significant mean difference between FFR measurement by the two agents [odds ratio (OR) = -0.00; 95% confidence interval (CI): (-0.02)-0.01, P = 0.88]. The cumulative correlation coefficient was 0.98 (0.96-0.99, P < 0.01). Three of five studies reported time to FFR with cumulative results favoring regadenoson (mean difference 34.31 s; 25.14-43.48 s, P < 0.01). Risk of adverse events was higher with adenosine compared to regadenoson (OR = 2.39; 95%CI: 1.22-4.67, P = 0.01), which most commonly included bradycardia and hypotension. Vast majority of the adverse events associated with both agents were transient.CONCLUSIONThe performance of regadenoson in inducing maximal hyperemia was comparable to that of adenosine. There was excellent correlation between the FFR measurements by both the agents. The use of adenosine, was however associated with higher risk of adverse events and longer time to FFR compared to regadenoson.

Recommendations for the Design and Delivery of Transitions-Focused Digital Health Interventions: Rapid Review.

BackgroundOlder adults experience a high risk of adverse events during hospital-to-home transitions. Implementation barriers have prevented widespread clinical uptake of the various digital health technologies that aim to support hospital-to-home transitions.ObjectiveTo guide the development of a digital health intervention to support transitions from hospital to home (the Digital Bridge intervention), the specific objectives of this review were to describe the various roles and functions of health care providers supporting hospital-to-home transitions for older adults, allowing future technologies to be more targeted to support their work; describe the types of digital health interventions used to facilitate the transition from hospital to home for older adults and elucidate how these interventions support the roles and functions of providers; describe the lessons learned from the design and implementation of these interventions; and identify opportunities to improve the fit between technology and provider functions within the Digital Bridge intervention and other transition-focused digital health interventions.MethodsThis 2-phase rapid review involved a selective review of providers’ roles and their functions during hospital-to-home transitions (phase 1) and a structured literature review on digital health interventions used to support older adults’ hospital-to-home transitions (phase 2). During the analysis, the technology functions identified in phase 2 were linked to the provider roles and functions identified in phase 1.ResultsIn phase 1, various provider roles were identified that facilitated hospital-to-home transitions, including navigation-specific roles and the roles of nurses and physicians. The key transition functions performed by providers were related to the 3 categories of continuity of care (ie, informational, management, and relational continuity). Phase 2, included articles (n=142) that reported digital health interventions targeting various medical conditions or groups. Most digital health interventions supported management continuity (eg, follow-up, assessment, and monitoring of patients’ status after hospital discharge), whereas informational and relational continuity were the least supported. The lessons learned from the interventions were categorized into technology- and research-related challenges and opportunities and informed several recommendations to guide the design of transition-focused digital health interventions.ConclusionsThis review highlights the need for Digital Bridge and other digital health interventions to align the design and delivery of digital health interventions with provider functions, design and test interventions with older adults, and examine multilevel outcomes.International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2020-045596

Is it possible to predict mortality and recurrence of VT afterablation? PAINESD risk score applicability vs new predictors

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Catheter ablation (CA) prevents ventricular tachycardia (VT) recurrences in patients (pts) with structural heart disease (SHD), and might have a favorable outcome, but is associated with severe short-term complications. Identification of pts at high risk of periprocedural acute haemodynamic decompensation has important implications at procedural planning. The PAINESD risk score is a promising tool to predict VT ablation procedure-related mortality. Aim To evaluate the accuracy of the PAINESD risk score to predict short-term mortality after structural VT ablation and to compare it with other conventional clinical predictors. Methods Prospective, observational, single-centre study of consecutive pts with SHD (ischemic or nonischemic), referred for VT-CA. High-density substrate maps were collected, through endocardial, epicardial or combined endo-epicardial approaches according to clinical data and operator preference. The primary endpoint was 30-day mortality or hemodynamic decompensation. Univariate Cox regression analysis was used to identify relevant clinical predictors and to compare them with the PAINESD risk score. Multivariable Cox proportional hazards regression models were used to estimate predictors of 30-day mortality. Results A total of 102 pts with SHD referred for VT ablation were evaluated(mean age: 67±11 years, 94% male, 78.4% in NYHA class I-II; mean LVEF was 34±11%). The baseline PAINESD risk score was 12.39±5.8, 19.6% at low risk, 36.3% at intermediate risk and 27.5% at high risk of adverse events. Overall 30-day mortality was 4.9%. The PAINESD did not predict 30-days mortality or hemodynamic decompensation (p= 0.93). Indeed, a non- significant trend to higher short and long-term mortality was noticed in high-risk score pts – Figure 1. On univariate analysis age&amp;gt;65 years (p=0.019), LVEF &amp;lt;35% (p=0.049), body mass index&amp;lt;28kg/m2 (p=0.019), CKD (p=0.001) and previous VT ablation (p=0.022) were prognostic predictors. On multivariate analysis, only LVEF&amp;lt;35% (HR2.225; CI95% 1.004-4-774,p=0.038) and CKD (HR 3.35; CI95%: 1.31-8.51, p=0.011) were independent predictors of short-term prognosis. Conclusions In our population, LVEF&amp;lt;35% and CKD were the strongest predictors of short-term mortality. PAINESD risk score was not accurate in predicting adverse events. New score systems must be derived for prognostic stratification in this population, incorporating the reduction on the actual short-term event rates after VT ablation.

Safety Evaluation of Cervical Dorsal Instrumentation in Geriatric Patients: Experience at a Level 1 Center for Spinal Surgery—A Single Center Cohort Study

ObjectiveDorsal instrumentation of the cervical spine is an established treatment in spine surgery. However, careful planning is required, particularly in elderly patients. This study evaluates early clinical outcomes in geriatric patients undergoing complex spine surgery.MethodsIn this retrospective, single center cohort study, we included all geriatric patients (aged ≥65 years) who underwent dorsal instrumentation between January 2013 and December 2020. We analyzed postoperative complications and the 30-day in-hospital mortality rate. Furthermore, the Charlson comorbidity index (CCI) and Clavien-Dindo grading system (CDG) were used to assess the patients' comorbidity burden.ResultsIn total, 153 patients were identified and included. The mean age of patients was 78 years (SD ± 7). Traumatic injury (53.6%) was the most common reason for surgery. 60.8% of the patients underwent dorsal instrumentation with 3 or more levels. The most common comorbidities were arterial hypertension (64%), diabetes mellitus (22.2%), coronary heart disease and atrial fibrillation (19.6%). The most common adverse event (AE) was pneumonia (4%) and the most common surgery-related complication was wound infection (5.2%). Among patients categorized as high risk for AE (CCI > 5), 14.6% suffered a postoperative AE. In our univariate analysis, we found no risk factors for high rates of complications or mortality.ConclusionOur data demonstrates that older patients were at no significant risk of postoperative complications. The CCI/CDG scores may identify patients at higher risk for adverse events after dorsal instrumentation, and these assessments should become an essential component of stratification in this older patient population.

A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia: a study protocol

BackgroundThe effectiveness of psychotropic medication on behavioral and psychological symptoms of dementia (BPSD) is limited, while associated with a higher risk of adverse events. Non-pharmacological treatment of BPSD is advocated as treatment of first choice. However, many general practitioners (GPs) find it difficult to initiate deprescribing, and when attempting to discontinue psychotropic medication in nursing home residents, they face many barriers. Therefore, we hypothesize that an intervention aimed at improving communication with and involvement of nursing home staff, relatives, and patients by GPs can optimize the pharmacological treatment of BPSD. The aim is to reduce the use of antidepressants in nursing home residents with dementia without increasing morbidity or mortality.ObjectiveThe primary outcome is reduction of antidepressant. Secondary outcomes include difference in use of other psychotropic medication, mortality, morbidity, and severity of BPSD.MethodThe study is a cluster-randomized controlled trial based in general practices in Denmark. We aim to include 22 practices, each of which will recruit up to 15 patients with dementia living in nursing homes. The intervention period is 3 months, and the total study period is 1 year. Randomization is 1:1 to intervention and control group by computer algorithm. Both groups receive education on BPSD and its evidence-based treatment. The intervention includes three tailored components; (1) teaching material and training to be used by the GP to educate nursing home staff on BPSD, (2) a pre-visit reflection tool to encourage nursing home staff to evaluate symptoms and reflect on relatives involvement in the discontinuation process; and (3) a dialog tool to facilitate shared decision making on optimization of BPSD treatment during the visits at the nursing home. The control group includes enhanced care as usual. The primary and secondary outcomes will be assessed at the end of the study period. A process evaluation will be conducted to assess the implementability.DiscussionWe anticipate that the intervention will optimize the treatment of BPSD with antidepressants for nursing homes residents and enhance compliance with reduction of medication. The process evaluation should provide insights into the barriers and facilitators to changing the current practice of deprescribing.Trial registrationClinicaltrials.gov NCT04985305. Registered on 30 July 2021.