NobleBlocks

St. Rita's Medical Center

Hospital / health systemLima, Ohio, United States

Research output, citation impact, and the most-cited recent papers from St. Rita's Medical Center (United States). Aggregated across the NobleBlocks index of 300M+ scholarly works.

Total works
261
Citations
5.3K
h-index
36
i10-index
75
Also known as
St. Rita's Medical Center

Top-cited papers from St. Rita's Medical Center

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation
Benedikt Schrage, Peter Moritz Becher, A. Bernhardt, Hiram G. Bezerra +4 more
2020· Circulation502doi:10.1161/circulationaha.120.048792

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score–matched cohort. Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63–0.98]; P =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site–related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock
Sandeep M. Patel, Jerry Lipinski, Sadeer Al‐Kindi, Toral Patel +4 more
2018· ASAIO Journal256doi:10.1097/mat.0000000000000767

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for refractory cardiogenic shock; however, it is associated with increased left ventricular afterload. Outcomes associated with the combination of a percutaneous left ventricular assist device (Impella) and VA-ECMO remains largely unknown. We retrospectively reviewed patients treated for refractory cardiogenic shock with VA-ECMO (2014-2016). The primary outcome was all-cause mortality within 30 days of VA-ECMO implantation. Secondary outcomes included duration of support, stroke, major bleeding, hemolysis, inotropic score, and cardiac recovery. Outcomes were compared between the VA-ECMO cohort and VA-ECMO + Impella (ECPELLA cohort). Sixty-six patients were identified: 36 VA-ECMO and 30 ECPELLA. Fifty-eight percent of VA-ECMO patients (n = 21) had surgical venting, as compared to 100% of the ECPELLA cohort (n = 30) which had Impella (±surgical vent). Both cohorts demonstrated relatively similar baseline characteristics except for higher incidence of ST-elevation myocardial infarction (STEMI) and percutaneous coronary intervention (PCI) in the ECPELLA cohort. Thirty-day all-cause mortality was significantly lower in the ECPELLA cohort (57% vs. 78%; hazard ratio [HR] 0.51 [0.28-0.94], log rank p = 0.02), and this difference remained intact after correcting for STEMI and PCI. No difference between secondary outcomes was observed, except for the inotrope score which was greater in VA-ECMO group by day 2 (11 vs. 0; p = 0.001). In the largest US-based retrospective study, the addition of Impella to VA-ECMO for patients with refractory cardiogenic shock was associated with lower all-cause 30 day mortality, lower inotrope use, and comparable safety profiles as compared with VA-ECMO alone.

Gene therapy for cancer: present status and future perspective
Magid H. Amer
2014· Molecular and Cellular Therapies240doi:10.1186/2052-8426-2-27

Advancements in human genomics over the last two decades have shown that cancer is mediated by somatic aberration in the host genome. This discovery has incited enthusiasm among cancer researchers; many now use therapeutic approaches in genetic manipulation to improve cancer regression and find a potential cure for the disease. Such gene therapy includes transferring genetic material into a host cell through viral (or bacterial) and non-viral vectors, immunomodulation of tumor cells or the host immune system, and manipulation of the tumor microenvironment, to reduce tumor vasculature or to increase tumor antigenicity for better recognition by the host immune system. Overall, modest success has been achieved with relatively minimal side effects. Previous approaches to cancer treatment, such as retrovirus integration into the host genome with the risk of mutagenesis and second malignancies, immunogenicity against the virus and/or tumor, and resistance to treatment with disease relapse, have markedly decreased with the new generation of viral and non-viral vectors. Several tumor-specific antibodies and genetically modified immune cells and vaccines have been developed, yet few are presently commercially available, while many others are still ongoing in clinical trials. It is anticipated that gene therapy will play an important role in future cancer therapy as part of a multimodality treatment, in combination with, or following other forms of cancer therapy, such as surgery, radiation and chemotherapy. The type and mode of gene therapy will be determined based on an individual's genomic constituents, as well as his or her tumor specifics, genetics, and host immune status, to design a multimodality treatment that is unique to each individual's specific needs.

Percutaneous tumor ablation with radiofrequency
Bradford J. Wood, Jeffrey R. Ramkaransingh, Tito Fojo, McClellan M. Walther +1 more
2002· Cancer166doi:10.1002/cncr.10234

BACKGROUND: Radiofrequency thermal ablation (RFA) is a new minimally invasive treatment for localized cancer. Minimally invasive surgical options require less resources, time, recovery, and cost, and often offer reduced morbidity and mortality, compared with more invasive methods. To be useful, image-guided, minimally invasive, local treatments will have to meet those expectations without sacrificing efficacy. METHODS: Image-guided, local cancer treatment relies on the assumption that local disease control may improve survival. Recent developments in ablative techniques are being applied to patients with inoperable, small, or solitary liver tumors, recurrent metachronous hereditary renal cell carcinoma, and neoplasms in the bone, lung, breast, and adrenal gland. RESULTS: Recent refinements in ablation technology enable large tumor volumes to be treated with image-guided needle placement, either percutaneously, laparoscopically, or with open surgery. Local disease control potentially could result in improved survival, or enhanced operability. CONCLUSIONS: Consensus indications in oncology are ill-defined, despite widespread proliferation of the technology. A brief review is presented of the current status of image-guided tumor ablation therapy. More rigorous scientific review, long-term follow-up, and randomized prospective trials are needed to help define the role of RFA in oncology.

Multiple neoplasms, single primaries, and patient survival
Magid H. Amer
2014· Cancer Management and Research129doi:10.2147/cmar.s57378

BACKGROUND: Multiple primary neoplasms in surviving cancer patients are relatively common, with an increasing incidence. Their impact on survival has not been clearly defined. METHODS: This was a retrospective review of clinical data for all consecutive patients with histologically confirmed cancer, with emphasis on single versus multiple primary neoplasms. Second primaries discovered at the workup of the index (first) primary were termed simultaneous, if discovered within 6 months of the index primary were called synchronous, and if discovered after 6 months were termed metachronous. RESULTS: Between 2005 and 2012, of 1,873 cancer patients, 322 developed second malignancies; these included two primaries (n=284), and three or more primaries (n=38). Forty-seven patients had synchronous primaries and 275 had metachronous primaries. Patients with multiple primaries were predominantly of Caucasian ancestry (91.0%), with a tendency to develop thrombosis (20.2%), had a strong family history of similar cancer (22.3%), and usually presented with earlier stage 0 through stage II disease (78.9%). When compared with 1,551 patients with a single primary, these figures were 8.9%, 15.6%, 18.3%, and 50.9%, respectively (P≤0.001). Five-year survival rates were higher for metachronous cancers (95%) than for synchronous primaries (59%) and single primaries (59%). The worst survival rate was for simultaneous concomitant multiple primaries, being a median of 1.9 years. The best survival was for patients with three or more primaries (median 10.9 years) and was similar to the expected survival for the age-matched and sex-matched general population (P=0.06991). CONCLUSION: Patients with multiple primaries are usually of Caucasian ancestry, have less aggressive malignancies, present at earlier stages, frequently have a strong family history of similar cancer, and their cancers tend to have indolent clinical behavior with longer survival rates, possibly related to genetic predisposition.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Role of Surgery in the Management of Adults With Metastatic Brain Tumors
Brian V. Nahed, Christopher Alvarez‐Breckenridge, Priscilla K. Brastianos, Helen A. Shih +4 more
2018· Neurosurgery115doi:10.1093/neuros/nyy542

Please see the full-text version of this guideline https://www.cns.org/guidelines/guidelines-treatment-adults-metastatic-brain-tumors/chapter_2) for the target population of each recommendation listed below. SURGERY FOR METASTATIC BRAIN TUMORS AT NEW DIAGNOSIS QUESTION: Should patients with newly diagnosed metastatic brain tumors undergo surgery, stereotactic radiosurgery (SRS), or whole brain radiotherapy (WBRT)? RECOMMENDATIONS: Level 1: Surgery + WBRT is recommended as first-line treatment in patients with single brain metastases with favorable performance status and limited extracranial disease to extend overall survival, median survival, and local control. Level 3: Surgery plus SRS is recommended to provide survival benefit in patients with metastatic brain tumors Level 3: Multimodal treatments including either surgery + WBRT + SRS boost or surgery + WBRT are recommended as alternatives to WBRT + SRS in terms of providing overall survival and local control benefits. SURGERY AND RADIATION FOR METASTATIC BRAIN TUMORS QUESTION: Should patients with newly diagnosed metastatic brain tumors undergo surgical resection followed by WBRT, SRS, or another combination of these modalities? RECOMMENDATIONS: Level 1: Surgery + WBRT is recommended as superior treatment to WBRT alone in patients with single brain metastases. Level 3: Surgery + SRS is recommended as an alternative to treatment with SRS alone to benefit overall survival. Level 3: It is recommended that SRS alone be considered equivalent to surgery + WBRT. SURGERY FOR RECURRENT METASTATIC BRAIN TUMORS QUESTION: Should patients with recurrent metastatic brain tumors undergo surgical resection? RECOMMENDATIONS: Level 3: Craniotomy is recommended as a treatment for intracranial recurrence after initial surgery or SRS. SURGICAL TECHNIQUE AND RECURRENCE QUESTION A: Does the surgical technique (en bloc resection or piecemeal resection) affect recurrence? RECOMMENDATION: Level 3: En bloc tumor resection, as opposed to piecemeal resection, is recommended to decrease the risk of postoperative leptomeningeal disease when resecting single brain metastases. QUESTION B: Does the extent of surgical resection (gross total resection or subtotal resection) affect recurrence? RECOMMENDATION: Level 3: Gross total resection is recommended over subtotal resection in recursive partitioning analysis class I patients to improve overall survival and prolong time to recurrence. The full guideline can be found at https://www.cns.org/guidelines/guidelines-treatment-adults-metastatic-brain-tumors/chapter_2.

Potential and Emerging Treatment Options for Ebola Virus Disease
Bryan M. Bishop
2014· Annals of Pharmacotherapy108doi:10.1177/1060028014561227

OBJECTIVE: To describe the current Ebola virus epidemic and the potential options for treatment and prevention of Ebola virus disease. DATA SOURCES: A PubMed literature search (1976 through October 20, 2014) was conducted using the search term Ebola. STUDY SELECTION AND DATA EXTRACTION: Animal and human studies published in English were selected. Studies published within the past 5 years were the primary focus of this review. DATA SYNTHESIS: The current Ebola virus epidemic has primarily been contained in West Africa though it has subsequently spread to other areas, including the United States. The first patient in the United States infected with Ebola virus was diagnosed, treated, and expired in Texas. Two nurses caring for this patient also were diagnosed with Ebola virus and have been successfully treated. Treatment options for patients infected with Ebola virus are limited. Supportive therapy is centered on fluid resuscitation, electrolyte imbalance correction, treating complicating infections, and preventing complications of shock. Experimental therapies (ZMapp, brincidofovir, TKM-Ebola, and favipiravir) have been used during this current outbreak. Several medications such as amiodarone, chloroquine, and clomiphene may prevent the transmission of or treat Ebola virus. Different vaccine therapies are also in early-stage development. One of the vaccine strategies using recombinant vesicular stomatitis virus as a delivery vector has demonstrated efficacy when used for preexposure and postexposure prophylaxis. CONCLUSION: Ebola virus is highly virulent and fatal, and treatment options are limited. Several experimental and existing therapies may be options for preventing and treating Ebola virus disease.

Revision Total Knee Arthroplasty
Wade Gofton, Harry Tsigaras, Reed Butler, James J. Patterson +2 more
2002· Clinical Orthopaedics and Related Research99doi:10.1097/00003086-200211000-00028

The number of revision total knee replacements continues to increase annually. To date, much of the literature has focused on the performance of titanium revision systems. The primary aim of the current study was to review the mid term results of a contemporary revision knee system, with alternative design features. Ninety-one consecutive patients having aseptic revision total knee arthroplasty with one, modular all-cobalt chrome stemmed revision knee system using hybrid stem fixation were studied prospectively. Eighty-nine revisions in 84 patients were reviewed at a mean of 5.9 years (range, 4.1-8.6 years). Significant improvements in pain scores (15 +/- 14 to 38 +/- 14), function (40 +/- 24 to 53 +/- 29), range of motion (88 degrees +/- 23 degrees to 98 degrees +/- 18 degrees ), and total Knee Society score (85 +/- 40 to 132 +/- 40) were seen at followup. Five patients had revision surgery, with a Kaplan-Meier survivorship of 93.5% at 8.6 years. Intermediate results support the use of cobalt chrome components and hybrid cement fixation; however, this fixation in combination with high articular constraint requires continued monitoring.

Review of the Mobile Stroke Unit Experience Worldwide
Victoria J. Calderon, Brittany M. Kasturiarachi, Eugene Lin, Vibhav Bansal +1 more
2018· Interventional Neurology79doi:10.1159/000487334

BACKGROUND: The treatment of stroke is dependent on a narrow therapeutic time window that requires interventions to be emergently pursued. Despite recent "FAST" initiatives that have underscored "time is brain," many patients still fail to present within the narrow time window to receive maximum treatment benefit from advanced stroke therapies, including recombinant tissue plasminogen activator (tPA) and mechanical thrombectomy. The convergence of emergency medical services, telemedicine, and mobile technology, including transportable computed tomography scanners, has presented a unique opportunity to advance patient stroke care in the prehospital field by shortening time to hyperacute stroke treatment with a mobile stroke unit (MSU). SUMMARY: In this review, we provide a look at the evolution of the MSU into its current status as well as future directions. Our summary statement includes historical and implementation information, economic cost, and published clinical outcome and time metrics, including the utilization rate of thrombolysis. KEY MESSAGES: Initially hypothesized in 2003, the first MSUs were launched in Germany and adopted worldwide in acute, prehospital stroke management. These specialized ambulances have made the diagnosis and treatment of many neurological emergencies, in addition to ischemic and hemorrhagic stroke, possible at the emergency site. Providing treatment as early as possible, including within the prehospital phase of stroke management, improves patient outcomes. As MSUs continue to collect data and improve their methods, shortened time metrics are expected, resulting in more patients who will benefit from faster treatment of their acute neurological emergencies in the prehospital field.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on Treatment Options for Adults With Multiple Metastatic Brain Tumors
Mario Ammirati, Brian V. Nahed, David W. Andrews, Clark C. Chen +1 more
2019· Neurosurgery58doi:10.1093/neuros/nyy548

TARGET POPULATION: These recommendations apply to adult patients newly diagnosed with multiple (more than 1) brain metastases. QUESTION 1: In what circumstances should whole brain radiation therapy be recommended to improve tumor control and survival in patients with multiple brain metastases? RECOMMENDATION: Level 2: It is recommended that whole brain radiation therapy can be added to stereotactic radiosurgery to improve local and distant control keeping in mind the potential for worsened neurocognitive outcomes and that there is unlikely to be a significant impact on overall survival. QUESTION 2: In what circumstances should stereotactic radiosurgery be recommended to improve tumor control and survival in patients with multiple brain metastases? RECOMMENDATIONS: Level 1: In patients with 2 to 3 brain metastases not amenable to surgery, the addition of stereotactic radiosurgery to whole brain radiation therapy is not recommended to improve survival beyond that obtained with whole brain radiation therapy alone. Level 3: The use of stereotactic radiosurgery alone is recommended to improve median overall survival for patients with more than 4 metastases having a cumulative volume < 7 cc. QUESTION 3: In what circumstances should surgery be recommended to improve tumor control and survival in patients with multiple brain metastases? RECOMMENDATION: Level 3: In patients with multiple brain metastases, tumor resection is recommended in patients with lesions inducing symptoms from mass effect that can be reached without inducing new neurological deficit and who have control of their cancer outside the nervous system.The full guideline can be found at https://www.cns.org/guidelines/guidelines-treatment-adults-metastatic-brain-tumors/chapter_6.

Genetic factors and breast cancer laterality
Magid H. Amer
2014· Cancer Management and Research57doi:10.2147/cmar.s60006

BACKGROUND: Women are more likely to develop cancer in the left breast than the right. Such laterality may influence subsequent management, especially in elderly patients with heart disease who may require radiation therapy. The purpose of this study was to explore possible factors for such cancer laterality. METHODS: In this work, clinical data for consecutive patients with histologically confirmed breast cancer were reviewed, with emphasis on clinical presentation and family history. RESULTS: Between 2005 and 2012, 687 patients with breast cancer were seen. Two women with incomplete data and eleven men were excluded. In total, 343 (50.9%) patients presented with left breast cancer, 311 (46.1%) with right breast cancer, and 20 (3.0%) with simultaneous bilateral malignancy. There were no significant differences between the three groups, especially in regards to clinical presentation and tumor characteristics. A total of 622 (92.3%) patients had unilateral primary, 20 (3.0%) had simultaneous bilateral, and 32 (4.7%) had metachronous primary breast cancer with subsequent contralateral breast cancer after 7.5-236 months. The worst 10-year survival was for bilateral simultaneous (18%) compared with unilateral (28%) and metachronous primaries (90%). There were no differences in survival in relation to breast cancer laterality, handedness, and presence or absence of a family history of cancer. There were significant similarities between patients and first-degree relatives in regards to breast cancer laterality, namely same breast (30/66, 45.5%), opposite breast (9/66, 13.6%), and bilateral cancer (27/66, 40.9, P=0.01163). This was more evident among patients and their sisters (17/32, 53.1%) or mothers (11/27, 40.7%, P=0.0689). There were also close similarities in relation to age at initial diagnosis of cancer for patients and their first-degree relatives for age differences of ≤5 years (48/166, 28.9%), 6-10 years (34/166, 20.5%), and >11 years (84/166, 50.6%, P=0.12065). CONCLUSION: High similarities between patients and their first-degree relatives in regards to cancer laterality and possibly age at initial diagnosis of cancer may suggest an underlying inherited genetic predisposition.

Antimicrobial Stewardship in the Emergency Department
Bryan M. Bishop
2015· Journal of Pharmacy Practice49doi:10.1177/0897190015585762

Antimicrobial resistance is a national public health concern. Misuse of antimicrobials for conditions such as upper respiratory infection, urinary tract infections, and cellulitis has led to increased resistance to antimicrobials commonly utilized to treat those infections, such as sulfamethoxazole/trimethoprim and flouroquinolones. The emergency department (ED) is a site where these infections are commonly encountered both in ambulatory patients and in patients requiring admission to a hospital. The ED is uniquely positioned to affect the antimicrobial use and resistance patterns in both ambulatory settings and inpatient settings. However, implementing antimicrobial stewardship programs in the ED is fraught with challenges including diagnostic uncertainty, distractions secondary to patient or clinician turnover, and concerns with patient satisfaction to name just a few. However, this review article highlights successful interventions that have stemmed inappropriate antimicrobial use in the ED setting and warrant further study. This article also proposes other, yet to be validated proposals. Finally, this article serves as a call to action for pharmacists working in antimicrobial stewardship programs and in emergency medicine settings. There needs to be further research on the implementation of these and other interventions to reduce inappropriate antimicrobial use to prevent patient harm and curb the development of antimicrobial resistance.

Relationship between anthropometric or functional characteristics and maximal serve velocity in professional tennis players.
Matteo Bonato, Martina Anna Maggioni, Claudio Rossi, Susanna Rampichini +2 more
2015· PubMed48

AIM: This study aims at investigating the possible relationships between anthropometric and functional parameters and maximal serve speed in professional tennis players. METHODS: Eight professional male tennis players (age 23±4 [mean±SD] years; height 181±4 cm; body mass 80±4 kg; playing experience 14±4 years; weekly training practice 29±6 hours) were recruited. Anthropometric parameters (height, body mass, arm-racquet length, arm muscle area), jump performance (squat jump, counter movement jump; counter movement jump free), handgrip strength and first and second maximal serve speed were assessed. RESULTS: Pearson's correlation coefficient showed significant (P<0.05) positive relationships between height and ball speed in both the first (r=0.78; P=0.02) and second (r=0.80; P=0.017) serve, and a significant negative correlation between serve speed and arm muscle area in first serve only (r=-0.78; P=0.03). In addition, a trend towards a positive correlation was observed between string tensions and serves speed for both first and second serves (r=0.54; P=0.16 and r=0.60; P=0.11, respectively). No significant relationship was found between serve speed and the other variables considered, including jumping performance parameters. CONCLUSION: Height was confirmed to be the main anthropometric determinant of serves speed in professional tennis players.

Improving the safety of medication administration using an interactive CD-ROM program
Philip J. Schneider, Craig A. Pedersen, Kathryn R. Montanya, Christine R. Curran +4 more
2005· American Journal of Health-System Pharmacy48doi:10.2146/ajhp040609

PURPOSE: The impact of an interactive CD-ROM program on the rate of medication administration errors made by nurses was studied. METHODS: This randomized, controlled, nonblinded study was conducted at three community hospitals. Study participants included 30 registered nurses who had at least one year of nursing experience in acute care and who worked on medical or medical-surgical units. Nurses were randomized to an intervention group that completed an interactive CD-ROM program on safe medication practices or to a control group. Direct observation was used to determine the baseline (preintervention) and postintervention error rates for both study and control groups. Three categories of errors were defined: deviation from safe administration practices (core 1), preparation and administration errors (core 2), and deviations from prescribed therapy (core 3). An error rate was calculated for each nurse, and the error rates for the study and control groups were based on the average error rate for the nurses in each group. RESULTS: The majority of errors made were core 1 errors. The nurse-level data showed a significant decrease in core 1 error rates between baseline and postintervention periods. Core 2 error rates were higher in the postintervention period, but the increase was not significant. Very few core 3 errors were made by either group during either period. CONCLUSION: An interactive CD-ROM enabled nurses to apply the information learned to identify errors in medication administration and improved adherence to safe medication administration practices.

Analytical Validation and Interobserver Reproducibility of EnzMet GenePro
Erinn Downs‐Kelly, James Pettay, David G. Hicks, Marek Skacel +4 more
2005· The American Journal of Surgical Pathology47doi:10.1097/01.pas.0000172294.67409.4f

Fluorescence in situ hybridization (FISH) has both excellent sensitivity and specificity in detecting HER2 gene amplification in invasive breast carcinoma. FISH has not been widely implemented in clinical practice because of reagent costs and the special instrumentation and expertise required to perform and integrate the assay. Immunohistochemistry (IHC) for HER2 protein is widely used, but false-positive and false-negative results are problematic. We developed a bright-field assay to visualize HER2 gene amplification and concomitant HER2 protein expression (EnzMet GenePro). This assay detects HER2 gene amplification via deposition of metallic silver by enzyme metallographytrade mark (EnzMettrade mark, Nanoprobes, Yaphank, NY) combined with HER2 protein detection by IHC using alkaline phosphatase and fast red K substrate visualization (CB11;Ventana, Tucson, AZ). The assay was performed on 94 invasive breast carcinomas, for which FISH (PathVysiontrade mark, Vysis, Downer's Grove, IL), conventional IHC (CB11), and enzyme metallography (EnzMettrade mark) results were known. The EnzMettrade mark component of the assay was scored as either HER2 gene amplified, polysomic, or nonamplified. The IHC component was scored using the conventional FDA scale of 0 to 3+. Concordance of the EnzMet component of the assay versus FISH was assessed and showed an excellent correlation (Pearson coefficient of 0.95; P < 0.001). The combination of gene and protein detection (EnzMet GenePro) displayed a specificity of 100% and an accuracy of 92.6% (95% confidence interval 85.3-97.0), facilitated recognition of gene/protein discordances, and allowed for efficient interpretation of the slide by conventional light microscopy. The interobserver kappa for each component was excellent (IHC, kappa = 0.94; and EnzMettrade mark, kappa = 0.96). EnzMet is the first bright-field ISH assay in our experience that routinely and nonambiguously detects endogenous HER2 signals, essential for a reliable clinical HER2 assay, and in combination with HER2 protein enables improved diagnosis in borderline cases.

Main issues addressed in the 2014–2015 revisions to the OECD Genetic Toxicology Test Guidelines
Véronique Thybaud, Elisabeth Lorge, Dan D. Levy, Jan van Benthem +4 more
2017· Environmental and Molecular Mutagenesis46doi:10.1002/em.22079

The Organization for Economic Cooperation and Development (OECD) recently revised the test guidelines (TGs) for genetic toxicology. This article describes the main issues addressed during the revision process, and the new and consistent recommendations made in the revised TGs for: (1) demonstration of laboratory proficiency; (2) generation and use of robust historical control data; (3) improvement of the statistical power of the tests; (4) selection of top concentration for in vitro assays; (5) consistent data interpretation and determination of whether the result is clearly positive, clearly negative or needs closer consideration; and, (6) consideration of 3R's for in vivo assay design. The revision process resulted in improved consistency among OECD TGs (including the newly developed ones) and more comprehensive recommendations for the conduct and the interpretation of the assays. Altogether, the recommendations made during the revision process should improve the efficiency, by which the data are generated, and the quality and reliability of test results. Environ. Mol. Mutagen. 58:284-295, 2017. © 2017 Wiley Periodicals, Inc.

Elderly patients with advanced NSCLC: The value of geriatric evaluation and the feasibility of CGA alternatives in predicting chemotherapy toxicity
Teresa Almodôvar, E. Teixeira, Ana Barroso, Marta Soares +3 more
2018· Pulmonology44doi:10.1016/j.pulmoe.2018.07.004

Cancer is primarily a disease of the elderly, with the incidence of older patients with cancer expected to increase in the coming years. Despite remarkable advances during the last decade, lung cancer remains a leading cause of mortality worldwide, non-small cell lung cancer (NSCLC) being the dominant (85-90%) subtype. At diagnosis, 50% of NSCLC patients are ≥70 years and 15%, over 80 years of age. Due to their under-representation in clinical trials, current treatment decisions for older patients with cancer are based on a low level of scientific evidence. The little evidence that exists suggests that chemotherapy is effective in elderly NSCLC patients, but also indicates that they are at more risk of chemotherapy toxicity than younger adults. However, if carefully selected and monitored, elderly patients can benefit from standard chemotherapy regimens. The Comprehensive Geriatric Assessment (CGA) has historically been adopted to identify elderly patients who are unfit for chemotherapy, yet in clinical practice this is often not feasible as it is too time-consuming. Two promising new tools have emerged - the CRASH and CARG scores - to assign patients to varying intensities of chemotherapy based on a pre-therapy risk assessment. The strengths and shortcomings of each tool were discussed by a group of six advisors with expertise in the treatment of NSCLC. Based on a literature review and on their personal experience, CRASH and CARG were considered feasible toxicity prediction tools, appropriate for implementation in routine clinical practice, with a potentially high impact in optimizing therapy selection for elderly patients with cancer.

Cancer-associated thrombosis: clinical presentation and survival
Magid H. Amer
2013· Cancer Management and Research44doi:10.2147/cmar.s47094

BACKGROUND: Thromboembolic events are important causes of morbidity and mortality in cancer patients. Clinical presentation in a community-based setting has not been fully clarified. The purpose of this study was to evaluate the incidence, risk factors, role of thrombophilia, and subsequent survival following thrombosis in cancer patients. METHODS: A retrospective review was undertaken of clinical data for all consecutive patients with histologically confirmed cancer seen by the author at a regional cancer center, with emphasis on cancer-related thrombosis. RESULTS: Between 2005 and 2012, of 1874 cancer patients, 307 (16.4%) developed thrombosis during their lifetime. Of these patients, 37 (2%) had a history of thrombosis, while the remaining 270 (14.4%) patients developed thrombosis 3 months before or any time after diagnosis of cancer, which was considered to be cancer-related. These patients included 230 (12.3%) with venous thrombosis, 28 (1.5%) cases with arterial occlusion, and 12 (0.6%) with combined venous and arterial thrombosis. Patients of Caucasian ancestry were more prone to develop thrombosis, with a higher frequency of multiple genetic thrombophilia compared with other ethnic groups. In regression analysis, only advanced stages of cancer and the presence of atherosclerosis were predictive of thrombosis. There were no significant differences between venous and arterial thrombosis. The worst survival was noted in patients who developed thrombosis 3 months prior to or shortly after their diagnosis of cancer. There has been a recent improved survival outcome following therapy. CONCLUSION: In addition to venous thrombosis, arterial occlusion with stroke and anginal symptoms is relatively common among cancer patients, especially those of Caucasian ancestry, and is possibly related to genetic predisposition.

Inpatient Experiences with MyChart Bedside
Erin L. Winstanley, Michelle Burtchin, Yifan Zhang, Paula Campbell +3 more
2017· Telemedicine Journal and e-Health33doi:10.1089/tmj.2016.0132

Background:As technology is increasingly being integrated into hospital-based care, it is important to assess patient experiences. The purpose of this project was to conduct an evaluation of inpatient experiences with MyChart®Bedside. Materials and Methods:A convenience sample of patients (n = 88) were included in this study, who responded to a Web-based self-reported survey that was embedded within the MyChart Bedside application. Results:The majority of respondents (78%) reported that MyChart Bedside was easy to use. The respondents agreed that MyChart Bedside improved communication with their nurses (74%) and with their physicians (53%), as well as helped them understand their medications (90%) during their inpatient hospitalization. Conclusions:The study found that the majority of patients were satisfied with MyChart Bedside, and they reported that it helped them learn more about their medications, as well as communicate with their care team.

Comparative Treatment Outcomes for Idiopathic Subglottic Stenosis: 5‐Year Update
William S. Tierney, Li‐Ching Huang, Sheau‐Chiann Chen, Lynn D. Berry +4 more
2023· Otolaryngology31doi:10.1002/ohn.190

The North American Airway Collaborative (NoAAC) previously published a 3-year multi-institutional prospective cohort study showing variation in treatment effectiveness between 3 primary surgical techniques for idiopathic subglottic stenosis (iSGS). In this report, we update these findings to include 5 years of data evaluating treatment effectiveness. Patients in the NoAAC cohort were re-enrolled for 2 additional years and followed using the prespecified published protocol. Consistent with prior data, prospective observation of 487 iSGS patients for 5 years showed treatment effectiveness differed by modality. Cricotracheal resection maintained the lowest rate of recurrent operation (5%), followed by endoscopic resection with adjuvant medical therapy (30%) and endoscopic dilation (50%). These data support the initial observations and continue to provide value to providers and patients navigating longitudinal decision-making. Level of evidence: 2-prospective cohort study.