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Morie Gertz,1,* Rafat Abonour,2,* Sarah N Gibbs,3,* Muriel Finkel,4,* Heather Landau,5,* Suzanne Lentzsch,6,* Grace Lin,7,* Anuj Mahindra,8,* Tiffany Quock,9,* Cara Rosenbaum,10,* Michael Rosenzweig,11,* Surbhi Sidana,12,* Sascha A Tuchman,13,* Ronald Witteles,12,* Irina Yermilov,3,* Michael S Broder3,* 1Department of Medicine, Mayo Clinic, Rochester, MN, USA; 2Department of Medicine, Indiana University School of Medicine; Director, Multiple Myeloma, Waldenstrom’s Disease and Amyloidosis Program, Indianapolis, IN, USA; 3PHAR (Partnership for Health Analytic Research), Beverly Hills, CA, USA; 4Amyloidosis Support Groups Inc, Wood Dale, IL, USA; 5Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 6Multiple Myeloma and Amyloidosis Program, Columbia University Medical Center, New York, NY, USA; 7Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA; 8Malignant Hematology, Scripps Clinic MD Anderson Cancer Center, La Jolla, CA, USA; 9Health Economics and Outcomes Research, Prothena Biosciences Ltd., South San Francisco, CA, USA; 10Department of Medicine, Hematology/Oncology, Weill Cornell Medical College, New York, NY, USA; 11Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA; 12Division of Cardiovascular Medicine, Stanford School of Medicine, Palo Alto, CA, USA; 13Division of Hematology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA*These authors contributed equally to this workCorrespondence: Michael S Broder, PHAR (Partnership for Health Analytic Research), 280 S Beverly Drive, Suite 404, Beverly Hills, CA, 90212, USA, Tel +1 310 858 9555, Email mbroder@pharllc.comPurpose: Patients with diagnosed with systemic light chain (AL) amyloidosis at advanced Mayo stages have greater morbidity and mortality than those diagnosed at non-advanced stages. Estimating service use by severity is difficult because Mayo stage is not available in many secondary databases. We used an expert panel to estimate healthcare utilization among advanced and non-advanced AL amyloidosis patients.Patients and Methods: Using the RAND/UCLA modified Delphi method, expert panelists completed 180 healthcare utilization estimates, consisting of inpatient and outpatient visits, testing, chemotherapy, and procedures by disease severity and organ involvement during two treatment phases (the 1 year after starting first line [1L] therapy and 1 year following treatment [post-1L]). Estimates were also provided for post-1L by hematologic treatment response (complete or very good partial response [CR/VGPR], partial, no response or relapse [PR/NR/R]). Areas of disagreement were discussed during a meeting, after which ratings were completed a second time.Results: During 1L therapy, 55% of advanced patients had ≥ 1 hospitalization and 38% had ≥ 2 admissions. Rates of hematopoietic stem cell transplant (HSCT) in advanced patients were 5%, while pacemaker or implantable cardioverter defibrillator (ICD) placement were 15%. During post-1L therapy, rates of hospitalization in advanced patients remained high (≥ 1 hospitalization: 20-43%, ≥ 2 hospitalizations: 10-20%), and up to 10% of advanced patients had a HSCT. Ten percent of these patients underwent pacemaker/ICD placement.Conclusion: Experts estimated advanced patients, who would not be good candidates for HSCT, would have high rates of hospitalization (traditionally the most expensive type of healthcare utilization) and other health service use. The development of new treatment options that can facilitate organ recovery and improve function may lead to decreased utilization.Keywords: consensus, hematology, outcomes research, mayo stage, cardiac failure

Charlotte Thor Petersen,1,2 Kristoffer Jarlov Jensen,1 Mary Rosenzweig,2 Benedikte Irene von Osmanski,1,2 Mikkel Zöllner Ankarfeldt,1 Janne Petersen1,3 1Copenhagen Phase IV Unit (Phase4CPH), Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark; 2Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark; 3Section of Biostatistics, University of Copenhagen, Copenhagen, DenmarkCorrespondence: Charlotte Thor Petersen, Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark, Tel +45 30 35 20 43, Email ctp@dlimi.comPurpose: There is an increasing need for national and international pharmacoepidemiological studies based on high-quality real-world data of which the Danish registries are a valuable source. In lack of a complete overview of which data are used to assess real-world drug safety and effectiveness outcomes, we aimed to map the outcomes, data sources, and the reporting of outcome quality in recent pharmacoepidemiological studies.Methods: We conducted a systematic mapping review of pharmacoepidemiological studies based on Danish registries investigating drug safety and/or effectiveness, published in the period 2018– 2019, identified in PubMed and Scopus. Extraction included: Anatomical Therapeutic Chemical level 2 code for drug exposures, outcomes, outcome data sources, and quality of outcomes.Results: Of the 210 included studies, 96% used outcomes categorized as Clinical, 4% utilized outcomes categorized as Society-related, 5% used outcomes categorized as Healthcare cost and utilization, and 3% of the studies applied outcomes categorized as Patient-reported in which the percentages are not mutually exclusive. Diagnosis (66%) and Mortality (38%) were the two most utilized subcategories among those categorized as Clinical outcomes. Danish Health Data Authority and Statistics Denmark registries were the most reported outcome data sources (90%). Ninety-six studies (46%) reported one or more quality parameters related to their outcomes of interest with accuracy/validity being the most reported parameter (22%).Conclusion: The Danish registries support a wide range of outcomes. Across therapeutic areas, most studies investigate traditional clinical outcomes of disease and mortality based on data from a small number of available registries. In contrast, clinical and biochemical databases, despite potentially offering outcomes with high responsiveness, and the high-quality social and healthcare cost registries were rarely used as outcome data sources.Keywords: pharmacoepidemiology, registries, review, Denmark, drugs

Alexa B Schrock,1 Russell Madison,1 Mark Rosenzweig,2 Justin M Allen,2 Rachel L Erlich,2 Siao-Yi Wang,3 Tarek Chidiac,4 Vodur Suresh Reddy,5 Jonathan W Riess,6 Ahmet Ersin Yassa,6 Abdur Shakir,7 Vincent A Miller,1 Brian M Alexander,1 Jeffrey Venstrom,1 Kimberly McGregor,1 Siraj M Ali1 1Foundation Medicine, Department of Clinical Development, Cambridge, MA, USA; 2Foundation Medicine, Department of Translational Oncology and Clinical Reporting, Cambridge, MA, USA; 3Loyola University Medical Cancer, Department of Hematology and Oncology, Maywood, IL, USA; 4Zangmeister Cancer Center, Department of Hematology and Oncology, Columbus, OH, USA; 5Cancer Care Specialists, Department of Hematology and Oncology, Reno, NV, USA; 6UC Davis Comprehensive Cancer Center, Department of Hematology and Oncology Sacramento, CA, USA; 7Sarah Bush Lincoln Health System, Department of Medical Oncology, Mattoon, IL, USACorrespondence: Alexa B SchrockFoundation Medicine, 150 Second Street, Cambridge, MA 02141, USATel +1617-418-2200Email aschrock@foundationmedicine.comBackground: ALK fusions are targetable drivers in non-small-cell lung cancer (NSCLC). However, patients with NSCLC harboring ALK rearrangements without a fusion partner identified in DNA have also been shown to respond to ALK inhibitors. We aimed to characterize complex ALK variants that may predict sensitivity to multiple approved ALK inhibitors.Methods: Comprehensive genomic profiling (CGP) of DNA isolated from formalin‐fixed paraffin‐embedded (FFPE) tumor tissue or blood-based circulating tumor DNA was performed for 39,159 NSCLC patients during routine clinical care. For a subset of cases, RNA sequencing was performed, and prior ALK test results and clinical treatment information were collected from treating physicians.Results: We queried the Foundation Medicine NSCLC database and identified ALK internal inversions, as well as internal deletions, as the sole ALK rearrangements in 6 (0.02%) and 3 (0.01%) of cases, respectively. In cases with ALK internal inversions, RNA testing identified an EML4-ALK fusion in 2/2 cases evaluated, and 3/3 patients treated with ALK inhibitors had durable responses. A single patient with an ALK internal deletion and clinical data available responded to multiple ALK inhibitors. RNA data available for a subset of non-NSCLC cases suggest that ALK internal deletions removing a portion of the N-terminus are drivers themselves and do not result in ALK fusions. Fluorescence in situ hybridization (FISH) results were inconsistent for both classes of DNA events.Conclusion: Rare internal inversions of ALK appear to be indicative of ALK fusions, which can be detected in RNA, and response to ALK inhibitors in patients with NSCLC. In contrast, ALK internal deletions are not associated with ALK fusions in RNA but likely represent targetable drivers themselves. These data suggest that CGP of DNA should be supplemented with immunohistochemistry or RNA-based testing to further resolve these events and match patients to effective therapies.Keywords: ALK rearrangement, inversion, deletion, genomic profiling, targeted therapy

Presents an optical method to control the geometry of buried layers in optoelectronic heterostructures. Description of the technique used; Characteristic near-band-gap spectral variations at different wavelengths; Analysis of the mushroom-type indium-gallium-arsenic-phosphorus/indium-phosphorus laser structure.

Presents information on a study which proposed a model which describes the evolution of degradation starting with invisible crystallographic defects. Description of the preparation and heating of samples; Details on degradation in protected crystals; Summary of the characteristic features of the proposed model; Conclusions on processing and device production.

Background: It is generally accepted that patients with breast cancer metastases have very poor survival. Metastatic breast cancer patients can be considered a heterogeneous population with a varied clinical course, which underscores the need for accurate prediction of survival based on prognostic factors. The purpose of the present study was to identify factors related to survival in breast cancer patients after diagnosis with metastatic disease. Populations and methods: A total of 557 patients with breast cancer metastasis diagnosis seen at one large urban practice have been followed up between 1 January, 1999 and 30 June, 2010. Demographic, tumor characteristics, clinical factors as predictors of survival were analyzed using log-rank test and Cox regression model. Results: The median survival length was 39 months (range 1-138 months) with 154 (27.7%) alive and 403 (72.3%) dead at the end of follow-up period. This study demonstrated that a history of hypertension, ER/PR status, HER2 status, metastasis-free interval, metastatic location (including brain, bone and liver), and BMI at diagnosis with metastatic breast cancer were the most relevant prognostic factors for survival after metastatic disease diagnosis. Conclusion: Findings of this study may form a foundation for the growing corpus of knowledge explaining the outcome differences in treatment of patients with metastatic breast cancer, potentially helping to create tailored counseling and personalized treatment approaches for this vulnerable group. [ABSTRACT FROM AUTHOR]

Background Effective communication skills for clinical practice are essential for all advanced practice nurses. However, competence in these skills is not necessarily intuitive. Advanced communication skills should be taught in a way that is similar to the way other psychomotor skills in advanced nursing practice programs are taught. Objectives To develop a patient communication simulation laboratory for the acute care nurse practitioner program at a major university and to evaluate students' perceived confidence and communication effectiveness before and immediately as well as 4 months after completion of the laboratory. Methods The communication simulation laboratory was developed in collaboration with faculty from the schools of nursing and medicine. Students participated in a didactic session and then completed a 2-hour communication simulation in the laboratory. Content and simulation concentrated on breaking 'bad news,' empathetic communication, motivational interviewing, and the 'angry' patient. Students' self-reported confidence and perceived skill in communication were measured via a Likert scale before, immediately after, and 4 months after completion of the laboratory simulation. Students also evaluated the experience by responding to open-ended questions. Results Compared with baseline findings (before the lecture and simulation), students' confidence in initiating difficult conversations increased significantly both immediately (P<.001) and 4 months after (P=.001) the laboratory simulation. Students' self-ratings of overall ability to communicate were also significantly greater immediately (P<.001) and 4 months (P=.001) after the simulation. Overall, students rated the laboratory simulation experience highly beneficial. Conclusions The content and methods used for the simulation improved students' confidence and perceived skill in communication in potentially difficult acute care situations. [ABSTRACT FROM AUTHOR]

Background: Communication skills have not traditionally been included in nursing curriculum. The best educational method to improve health care providers' practice in communication skills is first, introduction of content, followed by continuous skills assessment and mentored feedback.Methods: A communication skills workshop using standardized patients (SPs) was planned for oncology nurse practitioner students. A 6-step development plan was used to design, implement, and evaluate the curriculum. Three patient cases using SPs were developed to represent a specific communication skill. SP teaching methodology is relatively new to nursing curriculum. RESULTS. Four methods of evaluation revealed a high level of satisfaction with the course, a high level of communications skills demonstrated during the course, and student need to have more communication content throughout their curriculum. Confidence in communication skills increased following the workshop.Conclusions: This methodology has widespread application to other areas of cancer nursing including nurses with less oncology experience and practicing nurses on the oncology units. In addition, there is application throughout nursing curriculum for undergraduate and graduate programs. The content should be presented earlier in the curriculum and then reinforced throughout the remaining courses with clinical follow-up. [ABSTRACT FROM AUTHOR]

1. We tested the hypothesis thatGerbillus henleyi(de Winton 1903), the smallest species (10 g) of a pssamophilic guild in Israel, is scarce on relatively productive dunes of the Israeli desert, due to negative interactions from the commonG. allenbyi (Thomas 1918) andG. pyramidum(Geoffroy 1825).2. The alternative hypothesis was that scarcity on sand resulted from the size of its naked hind feet, that do not allow efficient locomotion on sand.3. Despite their naked soles the weight-bearing surface ofG. henleyifeet carry less mass/area than those of any other species.4. We measured interaction coefficients with the two common species using field-manipulation experiments in two enclosures.5. Habitat usage ofG. henleyichanged from significantly preferring the stabilized sand, when alone, to significantly using the semistabilized dune, whenG. allenbyiwas also present.6. We also estimated the interaction coefficients and calculated theG. henleyi's isoclines competing with the two common gerbil species using a technique we developed elsewhere.7. The stability analysis of the isoclines ofG. henleyicompeting with eitherG. allenbyior withG. pyramidumsuggests that stable coexistence occurs whenG. henleyiis relatively scarce while the competitors are common.8. Interspecific competition from eitherG. allenbyiorG. pyramidumaccounts for 90·3% reduction inG. henleyidensity, relative to when it is alone.9. We concluded that the negative interactions from congeners was the major cause for the scarcity ofG. henleyion the relatively rich sand dunes of the Israeli desert.Journal of Animal Ecology(2005)74, 567–578doi: 10.1111/j.1365-2656.2005.00956.x [ABSTRACT FROM AUTHOR]

PURPOSE: To describe three commercial weight loss programs (Jenny Craig, LA Weight Loss, and Weight Watchers), including efficacy data when available, and to provide clinicians with information for patient counseling. DATA SOURCES: Personal interviews, journal articles, and Web site information. CONCLUSIONS: Commercial weight loss programs provide weight loss services. Benefits are experience, planned menus, and psychological support. Limitations are cost, sales promotions that encourage on-the-spot commitment to prepaid contracts, and the cost of program food and additional vitamins. IMPLICATIONS FOR PRACTICE: Weight loss is a necessary goal for many patients. Clinicians are mandated to provide counseling regarding weight loss. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the New Immigrant Survey Pilot (NIS-P), a panel survey of a nationally representative sample of new legal immigrants to the United States based on probability samples of administrative records of the U.S. Immigration and Naturalization Service (INS). The NIS-P links survey information about immigrants' pre- and post-immigration labor market, schooling, and migratory experiences with data available from INS administrative records, including the visa type under which the immigrant was admitted. Results indicate that the procedures followed for locating, interviewing, and reinterviewing respondents yielded representative samples of new legal immigrants and high-quality data. On the basis of data obtained from the first round of the survey, we present new information never before available on the schooling and language skills of new immigrants and their earnings gains from immigration. [ABSTRACT FROM AUTHOR]

Ecologists need not despair of discovering the mechanisms that lead to large scale patterns. The search for process at higher scales has already led to enhanced confidence in the patterns and to improvements in their description. For example, species-area relationships turn out to form not one, but three patterns. Each is controlled by gain-loss dynamics at its own scale. At the macroscale, origination and global extinction reign. At the archipelagic scale, immigration and island extinction determine the results. At the local scale, metapopulation processes do. The three scales exhibit species-area curves with systematically different slopes in logarithmic space. We use the three scales of species-area to illuminate the relationship between local and regional diversity. Algebra shows that the latter pattern is an echo of species-area curves, and that those echoes ought to be nearly linear. So, we call the relationship of local and regional diversity, the Echo pattern. Ecology has long known that species-area curves within a region reflect the accumulation of habitat variety. Thus, theirconnection to Echo patterns argues against concluding that local diversity has little or nothing to do with population interactions. To obtain a pure Echo pattern, one should draw data from independent regions rather than separate islands. The independence allows natural selection to adjust the fundamental niches of species to diversity. Theory suggests that higher diversity should shrink niches, allowing the coexistence of more species locally. Hence, independence should tend to produce the straightest Echoes. However, archipelagic species-areacurves predict that even when different islands are used as the regions, the Echoes should show only very gentle curvatures. Flouting theory, some archipelagic Echoes approach an asymptote as regional diversity increases. These must have logarithmic slopes that increase withregional pool size. We do not understand why. [ABSTRACT FROM AUTHOR]