OBJECTIVES: To describe the development and initial results of an examination and certification process assessing competence in critical care echocardiography. DESIGN: A test writing committee of content experts from eight professional societies invested in critical care echocardiography was convened, with the Executive Director representing the National Board of Echocardiography. Using an examination content outline, the writing committee was assigned topics relevant to their areas of expertise. The examination items underwent extensive review, editing, and discussion in several face-to-face meetings supervised by National Board of Medical Examiners editors and psychometricians. A separate certification committee was tasked with establishing criteria required to achieve National Board of Echocardiography certification in critical care echocardiography through detailed review of required supporting material submitted by candidates seeking to fulfill these criteria. SETTING: The writing committee met twice a year in person at the National Board of Medical Examiner office in Philadelphia, PA. SUBJECTS: Physicians enrolled in the examination of Special Competence in Critical Care Electrocardiography (CCEeXAM). MEASUREMENTS AND MAIN RESULTS: A total of 524 physicians sat for the examination, and 426 (81.3%) achieved a passing score. Of the examinees, 41% were anesthesiology trained, 33.2% had pulmonary/critical care background, and the majority had graduated training within the 10 years (91.6%). Most candidates work full-time at an academic hospital (46.9%). CONCLUSIONS: The CCEeXAM is designed to assess a knowledge base that is shared with echocardiologists in addition to that which is unique to critical care. The National Board of Echocardiography certification establishes that the physician has achieved the ability to independently perform and interpret critical care echocardiography at a standard recognized by critical care professional societies encompassing a wide spectrum of backgrounds. The interest shown and the success achieved on the CCEeXAM by practitioners of critical care echocardiography support the standards set by the National Board of Echocardiography for testamur status and certification in this imaging specialty area.
Preface: promoting research in PLS: current knowledge and future challenges
ObjectiveThe aim of this systemic review is to compare different treatments for patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) to inform evidence‐based recommendations for the American College of Rheumatology (ACR)/Vasculitis Foundation (VF) Vasculitis Management Guidelines.MethodsA systemic review was conducted by searching articles in English using OVID Medline, PubMed, Embase, and the Cochrane Library. Articles were screened for suitability in addressing PICO questions, with studies presenting the highest level of evidence given preference.ResultsA total of 729 full‐text articles addressing GPA and MPA PICO questions were reviewed. For remission induction, rituximab was shown to be noninferior to cyclophosphamide (CYC) (odds ratio [OR]: 1.55, moderate certainty of evidence). The addition of plasma exchange to induction therapy in severe disease did not improve the composite end point of death or end stage renal disease (hazard ratio [HR]: 0.86 [95% confidence interval CI: 0.65, 1.13], moderate certainty of evidence). In nonsevere disease, methotrexate was noninferior to CYC for induction of remission (remission at 6 months of 90% vs. 94%). For maintenance of remission, methotrexate and azathioprine showed no difference in the risk of relapse over a mean follow‐up of 29 months (HR: 0.92, [95% CI: 0.52, 1.65]low certainty of evidence). As maintenance therapy, rituximab was superior to a tapering azathioprine strategy in major relapse‐free survival at 28 months (HR: 6.61, [95% CI: 1.56, 27.96], moderate certainty of evidence). In two randomized trials, longer‐term azathioprine maintenance therapy (>24 months) is associated with fewer relapses without an increase in adverse events.ConclusionThis comprehensive systematic review synthesizes and evaluates the benefits and toxicities of different treatment options for GPA and MPA.
Abstract PD14-09: Nci 10013 - A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel, with or without atezolizumab in triple negative breast cancer (TNBC)
Abstract Background Inhibition of PD-L1 with atezolizumab combined with chemotherapy has shown acceptable safety and improved survival in patients with metastatic PD-L1 positive triple negative breast cancer (TNBC). Patients with TNBC who do not achieve a pathological complete response (pCR) to neoadjuvant chemotherapy have a high risk of disease recurrence and death. This randomized, open-label, phase 2 trial evaluates neoadjuvant carboplatin and paclitaxel with or without atezolizumab in patients with previously untreated clinical stages II and III TNBC. Methods Women aged ≥18 years with clinical stage T2-T4c, any N, M0 primary tumor by AJCC 7th edition staging TNBC; ECOG PS 0-2; and no prior systemic therapy for the indexed breast cancer were eligible. Patients were randomized in a 1:2 ratio to carboplatin AUC5 q 3 weeks x 4 + paclitaxel 80 mg/m2 q week x 12 (Arm A), or carboplatin AUC5 q 3 weeks x 4 + paclitaxel 80 mg/m2 q week x 12 + atezolizumab 1200 mg q3 weeks x 4 (Arm B). Surgery was 3-6 weeks following neoadjuvant chemotherapy. Adjuvant dose-dense doxorubicin and cyclophosphamide was administered q2 weeks with growth factor support to all patients as per routine care. pCR and tumor infiltrating lymphocyte (TIL) percentages are the co-primary endpoints. pCR-evaluable population includes all eligible women who have been randomized and received at least one dose of combination therapy, while the TIL-evaluable population includes all eligible women who have evaluable TIL percentage after one cycle of therapy. A sample size of 67 (22 in Arm A, and 45 in Arm B) provided 80% power at 1-sided alpha = 0.10 to detect a minimum of 15% difference in TIL and 29% improvement (40% vs. 69%) in pCR, respectively. Herein, we report pCR results in the per protocol modified intent-to-treat population (mITT), which includes all eligible patients who were randomized and received at least one dose of combination therapy. Results Sixty-seven patients were randomized between 8/2017 and 9/2019. Six patients randomized to Arm A withdrew consent; 2 of these received protocol therapy but are excluded from the mITT analyses as they are not evaluable because definitive pathology reports are not available. Median follow up is 6 months (range 0.3 - 12.6 months). Median age is 52 years (range 25 - 78). Forty-three (64.2%) were Caucasian and thirteen (19.4%) were African American. Twenty-five (37.3%) were pre-menopausal. 67.2% and 32.8% had stages II and III disease respectively. Nine (13.4%) had a germline mutation in either BRCA1 or BRCA2. In the mITT population, 3 of 16 patients achieved pCR in Arm A - 18.8% (95% CI 4.0%- 45.6%), versus 25 of 45 patients in Arm B - 55.6% (95% CI 40.0%-70.4%); p value 0.018. pCR in those with BRCA mutations was 50% and 80% in Arm A and Arm B, respectively. Treatment delays were observed in 9 patients (40.9%) in Arm A, and 20 (44.4%) in Arm B; dose reductions occurred in 4 patients (18.1%) in Arm A, and in 6 (13.3%) in Arm B. There were 4 SAEs in Arm A and 10 in Arm B. One patient in Arm B had grade 3 adrenal insufficiency. One patient in Arm B died from recurrent disease during the follow-up period. Conclusions: The addition of atezolizumab to neoadjuvant carboplatin and paclitaxel resulted in an increased pCR rate in patients with clinical stages II and III TNBC. However, the pCR in the control Arm A was lower than expected, possibly due to the absence of neoadjuvant anthracyclines. The high pCR rate observed in the experimental arm of this study is similar to that observed in other neoadjuvant trials utilizing anthracyclines, taxanes, and carboplatin in TNBC. Clinical trial information: NCT02883062. Citation Format: Foluso O Ademuyiwa, Feng Gao, Ina Chen, Donald W Northfelt, Robert Wesolowski, Mili Arora, Adam Brufsky, Claire Dees, Cesar A Santa-Maria, Roisin M Connolly, Jeremy Force, Alvaro Moreno-Aspitia, Sarah Larson, Elad Sharon, William Gillanders. Nci 10013 - A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel, with or without atezolizumab in triple negative breast cancer (TNBC) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD14-09.
AbstractBackgroundCatheter ablation is associated with limited success rates in patients with persistent atrial fibrillation (AF). Currently, existing mapping systems fail to identify critical target sites for ablation. Recently, we proposed and validated several techniques (multiscale frequency [MSF], Shannon entropy [SE], kurtosis [Kt], and multiscale entropy [MSE]) to identify pivot point of rotors using ex‐vivo optical mapping animal experiments. However, the performance of these techniques is unclear for the clinically recorded intracardiac electrograms (EGMs), due to the different nature of the signals.ObjectiveThis study aims to evaluate the performance of MSF, MSE, SE, and Kt techniques to identify the pivot point of the rotor using unipolar and bipolar EGMs obtained from numerical simulations.MethodsStationary and meandering rotors were simulated in a 2D human atria. The performances of new approaches were quantified by comparing the “true” core of the rotor with the core identified by the techniques. Also, the performances of all techniques were evaluated in the presence of noise, scar, and for the case of the multielectrode multispline and grid catheters.ResultsOur results demonstrate that all the approaches are able to accurately identify the pivot point of both stationary and meandering rotors from both unipolar and bipolar EGMs. The presence of noise and scar tissue did not significantly affect the performance of the techniques. Finally, the core of the rotors was correctly identified for the case of multielectrode multispline and grid catheter simulations.ConclusionThe core of rotors can be successfully identified from EGMs using novel techniques; thus, providing motivation for future clinical implementations.
Protocol for the Examination of Specimens From Patients With Soft Tissue Tumors of Intermediate Malignant Potential, Malignant Soft Tissue Tumors, and Benign/Locally Aggressive and Malignant Bone Tumors
Background: Patient information is critical in shared decision-making and patient-centred management for neuroendocrine tumours (NETs). Most adults search the internet for health issues, with over half considering such information to be credible. Therefore, we evaluated the quality of online information on NETs. Methods: Searching for “Neuroendocrine Tumours”, the top 20 websites from Google and top 10 from Yahoo and Bing were identified. Open-access websites written in English were included. Websites indicated as advertisements or directed towards healthcare providers were excluded. Each website was evaluated using the JAMA benchmarks, DISCERN instrument, and the Health on the Internet (HONCode) seal by two independent reviewers. Results: We included 16 unique websites after removing duplicates. Four were education pages from healthcare institutions, 10 were Cancer Society pages, and 2 were general information pages. The average score for JAMA benchmarks was 2.3, with 19% of websites receiving the highest score of 4. Specifically, 31% met the benchmark for authorship, 69% for attribution, 94% for disclosure, and 44% for currency. The average score for the DISCERN instrument was 46.5, with no website achieving the maximum of 80 points. The HONCode seal was present in 3 out of 16 websites (18%). Conclusions: We identified major issues with the quality of online information for NETs using validated instruments. The majority of websites identified through common search engines are low-quality. Patients should be informed of the limited quality of online information on NETs. High-quality online information is needed to ensure that patients can avoid misinformation and actively participate in their care.
Best‐practices for preventing skin injury beneath personal protective equipment during the COVID‐19 pandemic: A position paper from the National Pressure Injury Advisory Panel
AbstractCOVID‐19 has infected millions of patients and impacted healthcare workers worldwide. Personal Protective Equipment (PPE) is a key component of protecting frontline clinicians against infection. The benefits of PPE far outweigh the risks, nonetheless, many clinicians are exhibiting skin injury caused by PPE worn incorrectly. These skin injuries, ranging from lesions to open wounds are concerning because they increase the susceptibility of viral infection and transmission to other individuals. Early into the COVID‐19 pandemic (April 2020), the U. S. National Pressure Injury Advisory Panel (NPIAP) developed a series of position statements to improve wear‐ability of PPE and protect healthcare professionals and their patients as safe from harm as possible under the circumstances. The NPIAP positions, which were formed by conducting a systematic review of what was known at the time, include: (a) Prepare skin before and after wearing PPE with skin sealants, barrier creams and moisturisers; (b) Frequent PPE offloading to relieve pressure and shear applied to skin; (c) treat visible skin injuries immediately caused by PPE to minimise future infection; (d) non‐porous dressings may provide additional skin protection, but lack evidence; (e) health systems should take care to educate clinicians about placement and personal hygiene related to handling PPE. Throughout all of these practices, handwashing remains a top priority to handle PPE. These NPIAP positions provided early guidance to reduce the risk of skin injury caused by PPE based on available research regarding PPE injuries, a cautious application of evidence‐based recommendations on prevention of device‐related pressure injuries in patients and the expert opinion of the NPIAP Board of Directors. Clinicians who adhere to these recommendations reduce the prospects of skin damage and long‐term effects (e.g. scarring). These simple steps to minimise the risk of skin injury and reduce the risk of coronavirus infection from PPE can help.