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Hansen, Miriam, and Julia Mendzheritskaya. "How University Lecturers’ Display of Emotion Affects Students’ Emotions, Failure Attributions, and Behavioral Tendencies in Germany, Russia, and the United States." Journal of Cross-Cultural Psychology 48, no. 5 (March 19, 2017): 734–53. http://dx.doi.org/10.1177/0022022117697845.
Повний текст джерелаАнотація:
In this study, we investigate whether the cultural-educational contexts in Russia, Germany, and the United States affect university students’ emotions, failure attributions, and behavioral tendencies after receiving negative achievement feedback from a lecturer. The 383 university students from Germany, Russia, and the United States participating in the study completed an online survey in which they read text vignettes of a university lecturer giving negative feedback to a student on his performance. We used a 2 × 3 × 3 experimental design to determine whether the negative feedback situation (private vs. public), the lecturer’s display of emotion (no emotion vs. anger vs. pity), and the cultural-educational contexts (German, Russian, U.S.) affected the participants’ judgment of the student’s affective and behavioral reactions to the negative feedback. Significant main effects and significant interactions were identified, for example, participants in Germany and in the United States reported stronger emotions in response to the negative feedback than the participants in Russia indicated. Also, compared with the participants in Germany and the United States, the participants in Russia attributed the student’s failure more often to external, unstable, and controllable factors and expected the student to adopt more approach tendencies after receiving the failure feedback. Furthermore, a culturally universal effect of emotional transmission between lecturer and student was found, as participants believed the student, for example, to feel anger when his lecturer displayed anger. Overall, the interplay of cultural-educational and situational contexts can affect the way students respond to the emotions a university lecturer displays, and those emotions can shape students’ learning behavior.
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Gadzhimuradova, Gyulnara, and Nemanja Vukcevic. "EU migration policy: policy of humanism vs threat to national security." Science. Culture. Society 29, no. 4 (December 15, 2023): 54–64. http://dx.doi.org/10.19181/nko.2023.29.4.5.
Повний текст джерелаАнотація:
Uncontrolled migration sweeping Europe is a priority of the political leadership led by a number of European states such as France, Italy, as well as their allies in the United States. The climate crisis in Europe also plays an important role here, which can be resolved, according to Germany, with the help of future “new citizens” who arrived from countries in Africa and the Middle East, exclusively with a Muslim population. What are the migration and immigrant policies in EU countries? How is the immigration policy of European countries being transformed? A detailed analysis of the current state of affairs in Europe is based on official data from the national statistical services of Germany, France, Great Britain, the Ministry of European Integration of the Republic of Serbia, the Department of Civil Liberty and Immigration of the Italian Republic, as well as international organizations - the Office of the United Nations High Commissioner for Refugees (UNHCR), the International Organization for Migration (IOM), Eurostat, World Bank. The article examines the security problem in connection with the penetration of radical Islam along with refugees. The authors reveal the consequences of the migration crisis in Europe and make an attempt to answer the question: is the reception and integration of refugees an act of humanity or a problem of national security for EU countries.
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Alba, Richard. "Bright vs. blurred boundaries: Second-generation assimilation and exclusion in France, Germany, and the United States." Ethnic and Racial Studies 28, no. 1 (January 2005): 20–49. http://dx.doi.org/10.1080/0141987042000280003.
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Vokinger, Kerstin Noëlle, Paola Daniore, ChangWon C. Lee, Aaron S. Kesselheim, and Thomas J. Hwang. "Launch prices and price developments of cancer drugs in the United States and Europe." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 2006. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.2006.
Повний текст джерелаАнотація:
2006 Background: Cancer drug costs are rising in the US and Europe. While drug manufacturers set prices without restriction in the US, European countries have regulations that allow national authorities to directly negotiate drug prices at launch and over time. We analyzed and compared the launch prices and price developments of cancer drugs in the US, Germany, Switzerland and England. Methods: We identified new drugs indicated to treat solid tumors in adults that were FDA-approved between 2009 and 2019 and had also been approved by the EMA and Swissmedic by 31 December 2019. Launch prices and post-launch price changes as of 1 January 2020 were extracted and adjusted to average sales prices for monthly treatment costs in the US and compared to comparable currency-adjusted ex-factory monthly treatment costs in Germany, Switzerland, and England. A cross-sectional analysis was conducted to infer yearly trends in launch prices and post-launch price changes across the countries. Results: The study cohort included 42 drugs for solid tumors, of which 40 (95%) drugs were first approved in the US compared to Germany and England, and 41 (98%) to Switzerland. Average launch prices for monthly treatment costs per patient were $15,178 in the US vs $7,049 in Germany, $7,421 in Switzerland and $8,176 in England, i.e., 215% (interquartile range [IQR] 263%-187%), 205% (IQR 202%-185%) and 186% (IQR 166%-189%) higher in the US compared to Germany, Switzerland and England respectively. Post-launch prices of 36 (86%), 40 (95%), and 38 (90%) drugs decreased over time with total savings of monthly treatment costs for all drugs in the study cohort of $86,744, $44,936, and $1744 in Germany, Switzerland, and England respectively. By contrast, prices of 8 (19%) drugs decreased, while 34 (81%) increased post-launch in the US with total additional expenses of $128,192 for monthly treatment costs. Conclusions: Launch prices for cancer drugs are far higher in the US than in Germany, Switzerland, or England. These price disparities continue to increase substantially after market entry since cancer drug prices, in general, decrease over time in Europe and increase in the US. Spending on cancer drugs could be reduced in the US if it adopted the principles used to more effectively negotiate drug prices in Europe.
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Walsh, Gianfranco. "Relationships among immigrant consumers' cultural orientation, innovativeness and opinion leadership." International Marketing Review 39, no. 1 (November 15, 2021): 80–104. http://dx.doi.org/10.1108/imr-03-2021-0141.
Повний текст джерелаАнотація:
PurposeThis research examines the direct and indirect effects of immigrant consumers' (heritage vs host) cultural orientation on their opinion leadership, in relation to heritage versus host culture peers. In addition to examining the potential mediation of different exhibitions of innovativeness, the research tests whether the relative size of the immigrant population in a country might affect the relationship of consumers' cultural orientation and opinion leadership.Design/methodology/approachTests of the theoretical arguments rely on data from three samples of more than 1,000 consumers collected from Russian immigrants to three countries–Israel, Germany and the United States.FindingsThis study offers broad support for the foundational theorizing, in that the findings confirm a mediating role of consumer innovativeness. Cultural orientation relates directly to opinion leadership, though only in two countries with a relatively small (Russian) immigrant population, that is, Germany and the United States. Accordingly, these findings have pertinent theoretical and practical implications.Originality/valueLittle research centers on opinion leaders among immigrant consumer segments or details the antecedents of opinion leadership relative to ethnic and immigrant consumer segments. This study contributes to marketing theory and practice by investigating immigrants from Russia who have migrated to Israel, Germany or the United States and by elucidating whether and to what extent their heritage versus host culture orientations exert indirect (via innovativeness) or direct impacts on their opinion leadership, expressed toward heritage and host culture peers.
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Varnavskii, V. "Systemic Crisis of Euro-zone: Economics vs Politics." World Economy and International Relations, no. 11 (2012): 43–49. http://dx.doi.org/10.20542/0131-2227-2012-11-43-49.
Повний текст джерелаАнотація:
The main problem of the Euro-zone is not even the financial crisis combusted and not sovereign debts, but the absence of viable ideas how to preserve the institutional structure, managerial system and separation of powers between Brussels and national governments, which are designed in the Maastricht Treaty. No personalities are seen on the EU political landscape who could offer a realistic way of the crisis recovery, without economic and social shocks. European society, including its educated part, the elites, doesn't believe either in modern leaders, or in tools of crisis recovery suggested by them. It was illustrated dramatically by presidential and parliamentary elections in France, regional elections in Germany. The financial and institutional reforms, worked out poorly and half-estimated, may be continued, but only as long as the economy stands political experiments on itself. Obviously, there is only one real alternative – whether a collapse of the Euro-zone, or a radical, tangible integration, working out and adoption of a Roadmap for some EU-countries' movement towards the United States of Europe creation on the space of viable, effective, competitive national economies, ready to sacrifice their sovereignty.
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Wahl, Hans-Werner, Johanna Drewelies, Sandra Duezel, Margie Lachman, Jacqui Smith, Nilam Ram, Ulman Lindenberger, and Denis Gerstorf. "No Historical Change in Views on Aging and Their Correlates: Emerging Evidence From Germany and the United States." Innovation in Aging 5, Supplement_1 (December 1, 2021): 286. http://dx.doi.org/10.1093/geroni/igab046.1111.
Повний текст джерелаАнотація:
Abstract To examine historical changes in views on aging, we compared matched cohorts of older adults within two independent studies that assessed differences across a two-decade interval, the Berlin Aging Studies (BASE, 1990/93 vs. 2017/18, each n = 256, Mage = 77) and the Midlife in the United States Study (MIDUS, 1995/96 vs. 2013/14, each n = 848, Mage = 67). Consistent across four different dimensions of individuals’ subjective views on aging (age felt, age appeared, desired age, attitudes towards own aging) in the Berlin Aging Studies and corroborated with subjective age felt in the MIDUS, there was no evidence whatsoever that older adults of today have more favorable views on how they age than older adults did two decades ago. We discuss reasons for our findings, including the possibility that individual age views may have become increasingly decoupled from societal age views.
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Kaufmann, Lutz, and Craig R. Carter. "International Supply Management Systems - The Impact of Price vs. Non-Price Driven Motives in the United States and Germany." Journal of Supply Chain Management 38, no. 3 (June 2002): 4–17. http://dx.doi.org/10.1111/j.1745-493x.2002.tb00131.x.
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Mahtani, Reshma, Alexander Niyazov, Bhakti Arondekar, Katie Lewis, Alex Rider, Lucy Massey, and Michael Patrick Lux. "BRCA1/2 Mutation Testing in Patients with HER2-Negative Advanced Breast Cancer: Real-World Data from the United States, Europe, and Israel." Cancers 14, no. 21 (November 2, 2022): 5399. http://dx.doi.org/10.3390/cancers14215399.
Повний текст джерелаАнотація:
Poly(adenosine diphosphate-ribose) polymerase inhibitors are approved to treat patients harboring a germline breast cancer susceptibility gene 1 or 2 mutation (BRCA1/2mut) with human epidermal growth factor receptor 2—negative (HER2−) advanced breast cancer (ABC). This study evaluated differences in patient demographics, clinical characteristics, and BRCA1/2mut testing within the United States (US), European Union 4 (EU4; France, Germany, Italy, and Spain), and Israel in a real-world population of patients with HER2− ABC. Oncologists provided chart data from eligible patients from October 2019 through March 2020. In the US, EU4, and Israel, 73%, 42%, and 99% of patients were tested for BRCA1/2mut, respectively. In the US and the EU4, patients who were not tested versus tested for BRCA1/2mut were more likely to have hormone receptor—positive (HR+)/HER2− ABC (US, 94% vs. 74%, p < 0.001; EU4, 96% vs. 78%, p < 0.001), less likely to have a known family history of BRCA1/2-related cancer (US, 6% vs. 19%, p = 0.002; EU4, 10% vs. 28%, p < 0.001), and were older (US, 68.9 vs. 62.5 years, p < 0.001; EU4, 66.7 vs. 58.0 years, p < 0.001). Among tested patients, genetic counseling was received by 45%, 53%, and 98% with triple-negative breast cancer, and 36%, 36%, and 98% with HR+/HER2− ABC in the US, EU4, and Israel, respectively. Efforts should be made to improve BRCA1/2 testing rates in the US and Europe.
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Kim, Paul J., Siobhan Lookess, Christine Bongards, Leah Passmore Griffin, and Allen Gabriel. "Economic model to estimate cost of negative pressure wound therapy with instillation vs control therapies for hospitalised patients in the United States, Germany, and United Kingdom." International Wound Journal 19, no. 4 (September 28, 2021): 888–94. http://dx.doi.org/10.1111/iwj.13689.
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Ogdie, A., L. Schmerold, W. Tillett, R. Germino, J. C. Cappelleri, and P. Young. "AB0811 DEMOGRAPHIC, TREATMENT AND DISEASE CHARACTERISTICS OF PATIENTS WITH PSORIATIC ARTHRITIS RECEIVING TOFACITINIB IN THE UNITED STATES, FRANCE, GERMANY, ITALY, SPAIN AND THE UNITED KINGDOM." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1707–8. http://dx.doi.org/10.1136/annrheumdis-2020-eular.982.
Повний текст джерелаАнотація:
Background:Tofacitinib is an oral JAK inhibitor for the treatment of psoriatic arthritis (PsA). The efficacy and safety of tofacitinib for PsA have been demonstrated in Phase 3 trials of up to 12 months’ (mos) duration.1,2Objectives:To describe demographic, treatment and disease characteristics of a sample of patients (pts) at initiation of tofacitinib for PsA in the United States (US), France, Germany, Italy, Spain and the United Kingdom (European Union Five; EU5).Methods:An online, retrospective medical chart review of de-identified pts treated with tofacitinib for PsA from the US and the EU5 was conducted by Ipsos Rheumatology Monitor between Sept and Dec 2019, after product approval for PsA (US, 5 mg twice daily [BID] and 11 mg once daily [QD]: Dec 2017; EU, 5 mg BID: June 2018). Rheumatology healthcare professionals (HCPs), recruited from a large panel, selected a sample of charts of pts ≥18 years of age who had a HCP-reported diagnosis of PsA and were prescribed tofacitinib. Extracted data included pt demographics, treatment characteristics (including treatments prior to tofacitinib) and disease characteristics at tofacitinib initiation (including HCP-reported disease severity).Results:Of 1564 pts (US n=436; EU5 n=1128, respectively) sampled by 391 HCPs, the majority were White (75%; 91%), female (both 52%) and 45–64 years of age (53%; 57%). At time of chart review, US pts had received tofacitinib for median (interquartile range [IQR]) 9 (7–11) mos, and EU5 pts for 7 (6–9) mos; 52% of US pts received 11 mg QD, and 84% of EU5 pts received 5 mg BID. Median (IQR) time from PsA diagnosis to tofacitinib initiation was 34 (12–68) mos for all pts with data available (n=1237), and was shorter for US (11 [3–33] mos) vs EU5 (40 [19–79] mos) pts. Most pts had received ≥1 prior targeted therapy (59%; biologic or targeted synthetic disease-modifying antirheumatic drugs) for median (IQR) 12 (7–22) mos. The most common HCP-reported reason for switching from prior targeted therapy was efficacy failure (US and EU5 both 59%); either initial failure (US 28%; EU5 13%) or long-term failure (US 34%; EU5 48%) (Figure 1A). Mechanism of action and mode of administration were the most common HCP-reported reasons for switching to tofacitinib in both the US and EU5 (Figure 1B). HCP-reported disease severity at tofacitinib initiation was higher in the EU5 than US (Figure 2).Conclusion:Characteristics of pts treated with tofacitinib for PsA were generally similar in the US and EU5. However, time from PsA diagnosis to tofacitinib initiation was shorter in the US vs EU5. It was of clinical interest to note that switching to tofacitinib appeared to be more commonly influenced by mechanism of action and mode of administration vs pt preference and access, as reported by HCPs. A key limitation of this study was the retrospective chart review design, which may introduce recall bias.References:[1]Mease et al. NEJM 2017;377:1537-50.[2]Gladman et al. NEJM 2017;377:1525-36.Acknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Dominic Singson of CMC Connect and funded by Pfizer Inc. Pt chart data were provided by Ipsos Rheumatology Monitor © Ipsos 2020, all rights reserved.Disclosure of Interests:Alexis Ogdie Shareholder of: Amgen, Novartis, Pfizer Inc, Grant/research support from: Novartis, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Luke Schmerold Consultant of: Astellas, Helsinn Therapeutics, Janssen, Pfizer Inc, Employee of: SmartAnalyst Inc, William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Rebecca Germino Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Joseph C Cappelleri Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Pamela Young Shareholder of: Pfizer Inc, Employee of: Pfizer Inc
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Ernst, Nicole, Frank Esser, Sina Blassnig, and Sven Engesser. "Favorable Opportunity Structures for Populist Communication: Comparing Different Types of Politicians and Issues in Social Media, Television and the Press." International Journal of Press/Politics 24, no. 2 (December 22, 2018): 165–88. http://dx.doi.org/10.1177/1940161218819430.
Повний текст джерелаАнотація:
The aim of this study is to explore favorable opportunity structures for populist communication of politicians in Western democracies. We analyze the content and style of 2,517 statements from 103 politicians from six countries (France, Italy, Germany, Switzerland, United Kingdom, and United States) who differ in their party affiliation (populist versus nonpopulist) and hierarchical position (backbencher vs. frontbencher). To learn more about their media strategies and chances of success, we investigate four communication channels (Facebook, Twitter, talk shows, and news media) that systematically differ in their degree of journalistic intervention and examine fourteen often-raised topics that differ in their suitability for populist mobilization. Our content analysis shows the highest probability of populist communication comes from (1) members of populist parties and (2) backbenchers who address (3) mobilizable issues in (4) social media or newspaper articles. We conclude by explaining why populists have become so successful in getting their messages into newspapers.
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Rodríguez Quijada, Mateo, and Svetlana Molkova. "URSS vs. EEUU, RDA vs. RFA: Guerra Fría en los Juegos Olímpicos de Verano (1952-1988) (U.S.S.R. vs. USA, GDR vs. FRG: Cold War at the Summer Olympics (1952-1988))." Retos, no. 33 (September 15, 2017): 37–39. http://dx.doi.org/10.47197/retos.v0i33.52809.
Повний текст джерелаАнотація:
Durante la Guerra Fría (1947-1991), las cuestiones geopolíticas determinaron el desarrollo del deporte internacional. Los Juegos Olímpicos se convirtieron en la arena de la lucha no solo deportiva sino política. Las victorias deportivas se utilizaban para mostrar la supremacia política, económica e ideológica de los países participantes. En la presente investigación se realiza un análisis de los medallistas de la Unión de Repúblicas Socialistas Soviéticas (URSS), los Estados Unidos (EEUU), la República Democrática Alemana (RDA) y la República Federal de Alemania (RFA) en los Juegos Olímpicos de Verano entre los años 1952 y 1988. Se analiza una muestra de 1945 medallistas olímpicos provenientes de los países indicados que compitieron durante 8 ediciones de los Juegos Olímpicos. Se excluyen del estudio los Juegos de Moscú 1980 y Los Ángeles 1984 debido a los boicots políticos por parte de EEUU y la RFA, y de la URSS y la RDA respectivamente. Los resultados del estudio muestran una clara superioridad de la URSS frente a los EE.UU. en casi todas las características estudiadas. La RDA, a su vez, supera a la RFA en la mayoría de variables analizadas. Los resultados ponen de manifiesto una supremacía de los países del bloque del este en los Juegos Olímpicos de Verano durante la Guerra Fría.Abstract. During the Cold War (1947-1991), geopolitical issues influenced international sports events. The Olympic Games became a space not only for sports competitions, but also for political clashes. Sports victories were used to pinpoint political, economic and ideological supremacy of the participating countries. The aim of the present research was to analyze the Summer Olympic medalists from the Union of Soviet Socialist Republics (U.S.S.R.), United States of America (USA), the German Democratic Republic (GDR) and the Federal Republic of Germany (FRG) in the period 1952-1988. We analyzed 1,945 Olympic medalists from above-mentioned countries, competing during 8 Summer Olympic Games. The 1980 Summer Olympics in Moscow and the 1984 Summer Olympics in Los Angeles were excluded due to political boycotts by the USA and the FRG and by the U.S.S.R. and the GDR, respectively. The results of our research show clear superiority of U.S.S.R in comparison to USA in almost all characteristics studied. GDR was better than FRG in most of the analyzed variables. Our outcomes reveal the supremacy of the Eastern Bloc countries at the Summer Olympics during the Cold War.
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Toth, Federico. "Integration vs separation in the provision of health care: 24 OECD countries compared." Health Economics, Policy and Law 15, no. 2 (December 11, 2018): 160–72. http://dx.doi.org/10.1017/s1744133118000476.
Повний текст джерелаАнотація:
AbstractThis article proposes a classification of the different national health care systems based on the way the network of health care providers is organised. To this end, we present two rivalling models: on the one hand, the integrated model and, on the other, the separated model. These two models are defined based on five dimensions: (1) integration of insurer and provider; (2) integration of primary and secondary care; (3) presence of gatekeeping mechanisms; (4) patient's freedom of choice; and (5) solo or group practice of general practitioners. Each of these dimensions is applied to the health care systems of 24 OECD countries. If we combine the five dimensions, we can arrange the 24 national cases along a continuum that has the integrated model and the separated model at the two opposite poles. Portugal, Spain, New Zealand, the UK, Denmark, Ireland and Israel are to be considered highly integrated, while Italy, Norway, Australia, Greece and Sweden have moderately integrated provision systems. At the opposite end, Austria, Belgium, France, Germany, the Republic of Korea, Japan, Switzerland and Turkey have highly separated provision systems. Canada, The Netherlands and the United States can be categorised as moderately separated.
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Kang, Yeong Seon, Eunji Huh, and Mi-Hee Lim. "Effects of Foreign Directors’ Nationalities and Director Types on Corporate Philanthropic Behavior: Evidence from Korean Firms." Sustainability 11, no. 11 (June 3, 2019): 3132. http://dx.doi.org/10.3390/su11113132.
Повний текст джерелаАнотація:
Addressing the fact that there are few studies exploring the relationship between board characteristics and corporate social responsibility (CSR) in non-Western contexts, this study examines the relationship in South Korean corporate contexts. We concentrate on foreign directors as a board attribute, which is reported as a remarkable change in Korean corporate boards, and propose that foreign directors have different impacts on CSR investment depending on their nationality (Anglo-Americans vs. non-Anglo-Americans) and director types (insiders vs. outsiders). In detail, the presence of directors from Anglo-American countries (e.g., the United States, the United Kingdom) decreases firms’ CSR involvement, whereas the presence of directors from non-Anglo-American countries (e.g., France, Germany) increases firms’ CSR involvement. Moreover, the effects of Anglo-Americans on CSR are strengthened when they are inside (rather than outside) directors. Empirical analyses using a sample of 1828 Korean firms from 2002 to 2015 provide evidence to support the predictions. This study theoretically contributes to CSR and corporate governance literature in that it sheds light on the CSR in non-Western companies and reveals varied effects of foreign directors contingent upon their individual attributes. It also has practical implications for policymakers and corporate managers by providing insights of the changes generated by foreign members in a boardroom.
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Wood, Robert, Steve Fermer, Sulabha Ramachandran, Scott Baumgartner, and Robert Morlock. "Patients with Gout Treated with Conventional Urate-lowering Therapy: Association with Disease Control, Health-related Quality of Life, and Work Productivity." Journal of Rheumatology 43, no. 10 (April 1, 2016): 1897–903. http://dx.doi.org/10.3899/jrheum.151199.
Повний текст джерелаАнотація:
Objective.Implications of inadequate gout control were assessed through health-related quality of life (HRQOL) and work productivity of patients with gout adequately controlled while taking conventional urate-lowering therapy (ULT) for ≥ 3 months vs those whose gout was inadequately controlled.Methods.Retrospective data were drawn from the Adelphi Disease Specific Programme (DSP), a cross-sectional survey of patients with gout in France, Germany, the United Kingdom, and the United States. Patients completed these questionnaires: EQ-5D (3L), Patient Reported Outcomes Measurement Information System (PROMIS) Health Assessment Questionnaire (HAQ), and Work Productivity and Activity Impairment. Inadequate control was defined as the most recent serum uric acid (SUA) level > 6 mg/dl (> 360 µmol/l) or ≥ 2 flares in the last 12 months; adequate control as SUA level ≤ 6 mg/dl (≤ 360 µmol/l) and 0 flares. Appropriate statistical tests were used to assess differences between groups.Results.There were 836 (69%) inadequately and 368 (31%) adequately controlled gout cases. Mean age was 61 and 63 years and duration of current ULT was 32 and 57 months, respectively. Patients experiencing inadequate control reported significantly worse functioning and HRQOL, as measured by the EQ-5D (0.790 vs 0.877; difference: −0.087; p < 0.001) and PROMIS HAQ (13.21 vs 6.91; difference: 6.30; p < 0.001) scales. Productivity was also more impaired (work time missed: 4.5% vs 1.3%; impairment while working: 19.1% vs 5.2%; overall work impairment: 20.4% vs 5.6%; activity impairment: 20.3% vs 5.3%; all p < 0.001).Conclusion.Less than one-third of patients had gout that was adequately controlled. Those experiencing inadequately controlled gout reported significantly worse functioning, quality of life, and work productivity. Gout treatment strategies to improve disease control may lead to improvements in HRQOL and productivity.
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Forrester, MB. "Bibliometric analysis of poison center-related research published in peer-review journals." Human & Experimental Toxicology 35, no. 7 (August 3, 2015): 705–12. http://dx.doi.org/10.1177/0960327115598386.
Повний текст джерелаАнотація:
Poison centers advance knowledge in the field of toxicology through publication in peer-review journals. This investigation describes the pattern of poison center-related publications. Cases were poison center-related research published in peer-review journals during 1995–2014. These were identified through searching the PubMed database, reviewing the tables of contents of selected toxicology journals, and reviewing abstracts of various national and international meetings. The following variables for each publication were identified: year of publication, journal, type of publication (meeting abstract vs. other, i.e. full article or letter to the editor), and the country(ies) of the poison center(s) included in the research. Of the 3147 total publications, 62.1% were meeting abstracts. There were 263 publications in 1995–1999, 536 in 2000–2004, 999 in 2005–2009, and 1349 in 2010–2014. The publications were in 234 different journals. The journals in which the highest number of research was published were Clinical Toxicology (69.7%), Journal of Medical Toxicology (2.2%), and Veterinary and Human Toxicology (2.1%). The research was reported from 62 different countries. The countries with the highest number of publications were the United States (67.9%), United Kingdom (6.5%), Germany (3.9%), France (2.5%), and Italy (2.4%). The number of publications increased greatly over the 20 years. Although the publications were in a large number of journals, a high proportion of the publications were in one journal. While the research came from a large number of countries, the preponderance came from the United States.
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Zhou, Lihua, and Ying Wu. "Validation of the Chinese version of the Achievement Emotions Questionnaire–Elementary School." Social Behavior and Personality: an international journal 49, no. 5 (May 5, 2021): 1–11. http://dx.doi.org/10.2224/sbp.10118.
Повний текст джерелаАнотація:
We developed the Chinese version of the Achievement Emotions Questionnaire–Elementary School (AEQ-ES), and tested its internal and external validity with a sample of 426 Chinese elementary school students aged between 6 and 10 years in three academic settings (class, homework, and test) of mathematics classes. The hierarchical model of the AEQ-ES for our Chinese sample was consistent with those obtained with samples of students in similar age groups in Italy, Germany, and the United States. We assessed the achievement emotions of enjoyment, boredom, and anxiety and found that girls (vs. boys) reported more class-related enjoyment, more academic effort, less classrelated anxiety, less boredom, and less homework-related boredom. Our results show that the Chinese version of the AEQ-ES is both valid and reliable; thus, it can be used in future studies.
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Cherry, James D. "The 112-Year Odyssey of Pertussis and Pertussis Vaccines—Mistakes Made and Implications for the Future." Journal of the Pediatric Infectious Diseases Society 8, no. 4 (February 22, 2019): 334–41. http://dx.doi.org/10.1093/jpids/piz005.
Повний текст джерелаАнотація:
AbstractEffective diphtheria, tetanus toxoids, whole-cell pertussis (DTwP) vaccines became available in the 1930s, and they were put into routine use in the United States in the 1940s. Their use reduced the average rate of reported pertussis cases from 157 in 100 000 in the prevaccine era to <1 in 100 000 in the 1970s. Because of alleged reactions (encephalopathy and death), several countries discontinued (Sweden) or markedly decreased (United Kingdom, Germany, Japan) use of the vaccine. During the 20th century, Bordetella pertussis was studied extensively in animal model systems, and many “toxins” and protective antigens were described. A leader in B pertussis research was Margaret Pittman of the National Institutes of Health/US Food and Drug Administration. She published 2 articles suggesting that pertussis was a pertussis toxin (PT)-mediated disease. Dr Pittman’s views led to the idea that less-reactogenic acellular vaccines could be produced. The first diphtheria, tetanus, pertussis (DTaP) vaccines were developed in Japan and put into routine use there. Afterward, DTaP vaccines were developed in the Western world, and definitive efficacy trials were carried out in the 1990s. These vaccines were all less reactogenic than DTwP vaccines, and despite the fact that their efficacy was less than that of DTwP vaccines, they were approved in the United States and many other countries. DTaP vaccines replaced DTwP vaccines in the United States in 1997. In the last 13 years, major pertussis epidemics have occurred in the United States, and numerous studies have shown the deficiencies of DTaP vaccines, including the small number of antigens that the vaccines contain and the type of cellular immune response that they elicit. The type of cellular response a predominantly, T2 response results in less efficacy and shorter duration of protection. Because of the small number of antigens (3–5 in DTaP vaccines vs >3000 in DTwP vaccines), linked-epitope suppression occurs. Because of linked-epitope suppression, all children who were primed by DTaP vaccines will be more susceptible to pertussis throughout their lifetimes, and there is no easy way to decrease this increased lifetime susceptibility.
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Schluchter, Helena, Ahmad T. Nauman, Sabine Ludwig, Vera Regitz-Zagrosek, and Ute Seeland. "Quantitative and Qualitative Analysis on Sex and Gender in Preparatory Material for National Medical Examination in Germany and the United States." Journal of Medical Education and Curricular Development 7 (January 2020): 238212051989425. http://dx.doi.org/10.1177/2382120519894253.
Повний текст джерелаАнотація:
Background: Sex- and gender-based medicine (SGBM) should be a mandatory part of medical education. We compared the quantity and quality of sex- and gender-related content of e-learning materials commonly used by German and American medical students while preparing for national medical examinations. Methods: Quantitative, line-by-line analysis of the preparatory materials AMBOSS 2017 and USMLE Step 1 Lecture Notes (2017) by KAPLAN MEDICAL was performed between April and October 2017. Subjects were allocated to one of the three main fields: clinical subjects, behavioral and social science, and pharmacology. Qualitative analysis comprised binary categorization into sex- and gender-based aspects and qualification with respect to the presence of a pathophysiological explanation for the sex or gender difference. Results: In relation to the total content of AMBOSS and KAPLAN, the sex- and gender-based share of the clinical subjects content was 26.8% (±8.2) in AMBOSS and 21.1% (±10.2) in KAPLAN. The number of sex- and gender-based aspects in the behavioral and social science learning material differed significantly for AMBOSS and KAPLAN (4.4% ± 3.1% vs 10.7% ± 7.5%; P = .044). Most of the sex- and gender-related content covered sex differences. Most learning cards and texts did not include a detailed pathophysiological explanation for sex- or gender-based aspects. The knowledge provided in the preparatory documents represents only a small part of facts that are already known about sex and gender differences. Conclusions: The preparatory materials focused almost exclusively on biological sex differences and the sociocultural dimension in particular is underrepresented. A lot more evidence-based facts are known and should be integrated into the materials to reflect the importance of SGBM as an integral component of patient-centered medicine.
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de Paula Couto, M. Clara P., Helene Fung, Sylvie Graf, Thomas M. Hess, Shyhnan Liou, Jana Nikitin, and Klaus Rothermund. "“OLDER ADULTS SHOULD…”: CROSS-NATIONAL DIFFERENCES IN ENDORSEMENT OF PRESCRIPTIVE AGE STEREOTYPES." Innovation in Aging 7, Supplement_1 (December 1, 2023): 268. http://dx.doi.org/10.1093/geroni/igad104.0892.
Повний текст джерелаАнотація:
Abstract Normative expectations about how older adults should behave are known as prescriptive age stereotypes (or “prescriptive views of aging,” PVoA). Previous research has shown that endorsement of PVoA varies across age groups but has not yet examined the variability of PVoA endorsement across countries. Considering that context may influence the endorsement of PVoA, we investigated differences in endorsement reported by an international sample of adults (N = 2,902) from the Aging as Future study covering the age range from 40 to 90 years in five countries: Czechia, Germany, Hong Kong, Taiwan, and the United States (US). We focused on endorsement of two types of PVoA, that is, disengagement (older adults should make way for the younger generation), and activation (older adults should remain socially engaged). Overall, participants reported a stronger endorsement of activation compared to disengagement (i.e., a focus on activation). Replicating previous studies, compared to young and middle-aged adults, older adults more strongly endorsed PVoA. Most importantly, cross-national differences emerged, indicating that overall endorsement of PVoA (averaged across activation and disengagement) was the strongest in Taiwan and the weakest in Czechia and Germany. However, the focus on activation (vs. disengagement) was the highest in the US followed by Hong Kong and Germany, and then by Czechia and Taiwan. Cross-national differences in the belief that the State should support older adults, in cultural values, and in views of own aging predicted the focus on activation and partially explained differences in the strength of this focus between countries.
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Larose, Martin. "Kaim, Markus et Ursula Lehmkuhl (dir.), In Search of a New Relationship. Canada, Germany, and the United States, Wiesbaden, vs Verla für Sozialwissenschaften, 2005, 160 p." Études internationales 37, no. 4 (2006): 665. http://dx.doi.org/10.7202/014651ar.
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Scheer, Volker, David Valero, Elias Villiger, Thomas Rosemann, and Beat Knechtle. "The Impact of the COVID-19 Pandemic on Endurance and Ultra-Endurance Running." Medicina 57, no. 1 (January 9, 2021): 52. http://dx.doi.org/10.3390/medicina57010052.
Повний текст джерелаАнотація:
Background and objectives: The COVID-19 outbreak has become a major health and economic crisis. The World Health Organization declared it a pandemic in March 2020, and many sporting events were canceled. Materials and Methods: We examined the effects of the COVID-19 pandemic on endurance and ultra-endurance running (UER) and analyzed finishes and events during the COVID-19 pandemic (observation period March 2020–October 2020) to the same time period pre-COVID-19 outbreak (March 2019–October 2019). Results: Endurance finishes decreased during the pandemic (459,029 to 42,656 (male: 277,493 to 25,582; female 181,536 to 17,074; all p < 0.001). Similarly, the numbers of endurance events decreased (213 vs. 61 events; p < 0.001). Average marathon finishing times decreased during the pandemic in men (5:18:03 ± 0:16:34 vs. 4:43:08 ± 0:25:08 h:min:s (p = 0.006)) and women (5:39:32 ± 0:19:29 vs. 5:14:29 ± 0:26:36 h:min:s (p = 0.02)). In UER, finishes decreased significantly (580,289 to 110,055; p < 0.001) as did events (5839 to 1791; p < 0.001). Popular event locations in United States, France, UK, and Germany decreased significantly (p < 0.05). All distance and time-limited UER events saw significant decreases (p < 0.05). Conclusions: The COVID-19 pandemic has had a significant effect on endurance and UER, and it is unlikely that running activities return to pre-pandemic levels any time soon. Mitigation strategies and safety protocols should be established.
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Scheer, Volker, David Valero, Elias Villiger, Thomas Rosemann, and Beat Knechtle. "The Impact of the COVID-19 Pandemic on Endurance and Ultra-Endurance Running." Medicina 57, no. 1 (January 9, 2021): 52. http://dx.doi.org/10.3390/medicina57010052.
Повний текст джерелаАнотація:
Background and objectives: The COVID-19 outbreak has become a major health and economic crisis. The World Health Organization declared it a pandemic in March 2020, and many sporting events were canceled. Materials and Methods: We examined the effects of the COVID-19 pandemic on endurance and ultra-endurance running (UER) and analyzed finishes and events during the COVID-19 pandemic (observation period March 2020–October 2020) to the same time period pre-COVID-19 outbreak (March 2019–October 2019). Results: Endurance finishes decreased during the pandemic (459,029 to 42,656 (male: 277,493 to 25,582; female 181,536 to 17,074; all p < 0.001). Similarly, the numbers of endurance events decreased (213 vs. 61 events; p < 0.001). Average marathon finishing times decreased during the pandemic in men (5:18:03 ± 0:16:34 vs. 4:43:08 ± 0:25:08 h:min:s (p = 0.006)) and women (5:39:32 ± 0:19:29 vs. 5:14:29 ± 0:26:36 h:min:s (p = 0.02)). In UER, finishes decreased significantly (580,289 to 110,055; p < 0.001) as did events (5839 to 1791; p < 0.001). Popular event locations in United States, France, UK, and Germany decreased significantly (p < 0.05). All distance and time-limited UER events saw significant decreases (p < 0.05). Conclusions: The COVID-19 pandemic has had a significant effect on endurance and UER, and it is unlikely that running activities return to pre-pandemic levels any time soon. Mitigation strategies and safety protocols should be established.
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Rychlowska, Magdalena, Yuri Miyamoto, David Matsumoto, Ursula Hess, Eva Gilboa-Schechtman, Shanmukh Kamble, Hamdi Muluk, Takahiko Masuda, and Paula Marie Niedenthal. "Heterogeneity of long-history migration explains cultural differences in reports of emotional expressivity and the functions of smiles." Proceedings of the National Academy of Sciences 112, no. 19 (April 20, 2015): E2429—E2436. http://dx.doi.org/10.1073/pnas.1413661112.
Повний текст джерелаАнотація:
A small number of facial expressions may be universal in that they are produced by the same basic affective states and recognized as such throughout the world. However, other aspects of emotionally expressive behavior vary widely across culture. Just why do they vary? We propose that some cultural differences in expressive behavior are determined by historical heterogeneity, or the extent to which a country’s present-day population descended from migration from numerous vs. few source countries over a period of 500 y. Our reanalysis of data on cultural rules for displaying emotion from 32 countries [n = 5,340; Matsumoto D, Yoo S, Fontaine J (2008) J Cross Cult Psychol 39(1):55–74] reveals that historical heterogeneity explains substantial, unique variance in the degree to which individuals believe that emotions should be openly expressed. We also report an original study of the underlying states that people believe are signified by a smile. Cluster analysis applied to data from nine countries (n = 726), including Canada, France, Germany, India, Indonesia, Israel, Japan, New Zealand, and the United States, reveals that countries group into “cultures of smiling” determined by historical heterogeneity. Factor analysis shows that smiles sort into three social-functional subtypes: pleasure, affiliative, and dominance. The relative importance of these smile subtypes varies as a function of historical heterogeneity. These findings thus highlight the power of social-historical factors to explain cross-cultural variation in emotional expression and smile behavior.
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Patel, K. V., P. Salmon, I. Marin-Jiménez, M. Thessen, K. Kligys, D. Sharma, Y. Sanchez Gonzalez, and J. Kershaw. "P416 The impact of remission on healthcare resource utilisation and costs amongst patients with inflammatory bowel disease in France, Germany, Italy, Spain, and the United Kingdom." Journal of Crohn's and Colitis 17, Supplement_1 (January 30, 2023): i544—i546. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0546.
Повний текст джерелаАнотація:
Abstract Background Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with increasing healthcare resource utilisation (HCRU) and associated costs. Optimal management of CD and UC aims to induce and maintain remission which may subsequently lower HCRU and costs. This study reports on the potential impact on HCRU and associated direct HCRU costs (excluding drug costs) from achieving CD or UC remission in France, Germany, Italy, Spain and the United Kingdom (EU5). Methods Data were drawn from an Adelphi Real World IBD Disease Specific ProgrammeTM, a point in time survey collected from gastroenterologists and their IBD patients in EU5 in Sep 2020-Jan 2021. GEs completed a patient record form for their next 5-10 consulting IBD patients covering demographics, remission status, healthcare professional visits, tests used to diagnose and monitor CD/UC, hospitalisations and surgeries related to IBD. Patients were stratified into two groups based on GE stated remission status from set categories: remission (RE) vs non-remission (NR). Associated HCRU costs were sourced from published healthcare system reports per country. Outcomes and costs were compared between patients in RE vs NR using inverse probability weighted regression statistical analysis (α=0.05), adjusting for age, sex, BMI, smoking status, disease location, and current treatment. Results A total of 1,526 CD patients were analysed and split into patients in RE (n=1,021) and NR (n=505; Figure 1). Compared with CD patients in NR, patients in RE experienced a lower risk of at least one hospitalization (12.8% vs 29.8%; p<0.001) and surgery (13.8% vs 26.0%; p<0.0001) (Figure 2), and fewer visits to HCPs in the last 12 months (6.5 vs 7.4; p=0.005) (Figure 3). Furthermore, total HCRU cost was 53% less for patients in RE vs NR (€1410.4 vs €2153.4; p=0.0002), with 16% lower HCP visit and test costs (€637.1 vs €737.3; p<0.001) and 83% lower hospitalisation and surgery costs (€773.3 vs €1416.2; p=0.001) (Figure 3). In addition, 1,447 UC patients were analysed and split into patients in RE (n=968) and NR (n=479; Figure 1). Compared to UC patients in NR, patients in RE experienced a lower risk of at least one hospitalization (11.4% vs 24.3%; p<0.0001) and surgery (1.8% vs 5.0%; p=0.004 (Figure 1), and fewer HCP visits (6.0 vs 7.1; p<0.001) (Figure 3). Total HCRU cost trended lower amongst patients in RE vs NR (€1219.6 vs €1443.0; p=0.085), with 19% lower costs of HCP visit and test costs (€617.3 vs €734.7; p<0.0001). Conclusion Patients with IBD who achieve remission present lower HCRU burden, lower risk of hospital and surgery, and ultimately lower associated direct HCRU costs to healthcare systems in EU5.
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Norman, John G., Stephen Brealey, Ada Keding, David Torgerson, and Amar Rangan. "Does time to surgery affect patient-reported outcome in proximal humeral fractures? A subanalysis of the PROFHER randomized clinical trial." Bone & Joint Journal 102-B, no. 1 (January 2020): 33–41. http://dx.doi.org/10.1302/0301-620x.102b1.bjj-2020-0546.r1.
Повний текст джерелаАнотація:
Aims The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures Methods A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot. Results The mean time from initial trauma to surgery was 10.5 days (1 to 33). Earlier surgical intervention did not improve OSS throughout follow-up, nor when stratified by participant age (< 65 years vs ≥ 65 years) and fracture severity (one- and two-part vs three- and four-part fractures). Participants managed later than reported international averages (three days in the United States and Germany, eight days in the United Kingdom) did not have worse outcomes. At five-year follow-up, 50 participants (76%) had the same or improved OSS compared with six months (six-month mean OSS 35.8 (SD 10.0); five-year mean OSS 40.1 (SD 9.1); r = 0.613). A Bland-Altman plot demonstrated a positive mean difference (3.3 OSS points (SD 7.92)) with wide 95% limits of agreement (-12.2 and 18.8 points). Conclusion Timing of surgery did not affect OSS at any stage of follow-up, irrespective of age or fracture type. Most participants had maximum functional outcome at six months that was maintained at five years. These findings may help guide providers of trauma services on surgical prioritization. Cite this article: Bone Joint J 2020;102-B(1):33–41
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Hossain, Arif. "Peace, Conflict and Resolution (Good vs. Evil)." Bangladesh Journal of Bioethics 4, no. 1 (March 26, 2013): 9–19. http://dx.doi.org/10.3329/bioethics.v4i1.14264.
Повний текст джерелаАнотація:
The immense structural inequalities of the global social /political economy can no longer be contained through consensual mechanisms of state control. The ruling classes have lost legitimacy; we are witnessing a breakdown of ruling-class hegemony on a world scale. There is good and evil among mankind; thus it necessitates the conflict between the good and evil on Earth. We are in for a period of major conflicts and great upheavals. It's generally regarded that Mencius (c.371- c.289 B.C) a student of Confucianism developed his entire philosophy from two basic propositions: the first, that Man's original nature is good; and the second, that Man's original nature becomes evil when his wishes are not fulfilled. What is good and what is evil? Philosophers of all ages have thought over this question. Each reckoned that he had solved the question once and for all, yet within a few years the problem would re-emerge with new dimensions. Repeated acts of corruption and evil action makes a man corrupt and takes away a man from his original nature. Still now majority of the people of the world give compliance to corruption because of social pressures, economic pressures, cultural pressures and political pressures. The conflict between good and evil is ancient on earth and is prevalent to this day. May be the final confrontation between the descendants of Cain and Abel is at our doorsteps. During the 2nd World War America with its European allies went into world wide military campaign to defeat Germany, Italy and Japan. When the Second World War ended in 1945 the United States of America came out as victorious. America was the first country to detonate atomic bomb in another country. During that period Russia fell into competition with America in politically colonizing countries after countries. With the fall of Communism Russia terminated its desire wanting to be the champion of the oppressed of the world. The situation in Russia continues to deteriorate, a country which until only a few years ago was a superpower. Russians are deeply disillusioned today with the new politicians in Russia, who they says "promise everything and give nothing." The Russians still strongly oppose a world order dominated by the United States. If anyone looks at or investigates the situations in other countries it can be seen that at present almost all countries of the world are similar or same in the forms of structures of corruption and evil. The Worldwide control of humanitys economic, social and political activities is under the helm of US corporate and military power. The US has established its control over 191 governments which are members of the United Nations. The last head of state of the former Soviet Union, Mikhail Gorbachev on December 2012, at a conference on the future of the Middle East and the Black Sea region in the Turkish city of Istanbul, has warned the US of an imminent Soviet-like collapse if Washington persists with its hegemonic policies. Mass public protest occurred against US hegemony are mainly from Muslim countries of South East Asia, South Asia, Central Asia, West Asia, North Africa and Africa. The latest mass protests erupted in September 2012 when the divine Prophet Muhammad (pbuh) was insulted by America and Israel. There were strong mass protests by people from Indonesia to Morocco and in the European countries by mostly immigrants and Australia were there are Muslim populations. This worldwide protest had occurred while the rise of the masses is ongoing against corrupt rulers in West Asia and North Africa. The masses of the people are thirsty and desperate for justice, dignity, economic welfare and human rights. Most major religions have their own sources of information on the Last Age of Mankind or the End of Times, which often include fateful battles between the forces of good and evil and cataclysmic natural disasters. Humans are evolving to a final stage of their evolution towards a 'New Age that is to come which the corrupt does not understand. At present times a final battle of good versus evil on Earth will ensue. The World powers (leaders) and their entourages who are really detached from the masses have organized to keep aloft the present world order that degenerates the masses in corruption, keeps the people in unhappiness, and deprives the masses from economic well being, education and keeps promoting wars and conflicts to support corruption and evil. We are at the ?End of Times?. The Promised Messiah will come to set right what is wrong, no doubt. DOI: http://dx.doi.org/10.3329/bioethics.v4i1.14264 Bangladesh Journal of Bioethics 2013; 4(1):9-19
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Patel, Rahul, Krishna Sajeev, Vani Sojitra, Krina Manojbhai Patel, Pranathi Royal Naradasu, Sneh Patel, and Hardik Dineshbhai Desai. "EVOLVING LANDSCAPE OF INFLAMMATORY BOWEL DISEASE IN G20 NATIONS (1990-2019): A COMPREHENSIVE GLOBAL ASSESSMENT." Inflammatory Bowel Diseases 30, Supplement_1 (January 25, 2024): S31. http://dx.doi.org/10.1093/ibd/izae020.069.
Повний текст джерелаАнотація:
Abstract BACKGROUND As pivotal players in the global economy, the G20 countries not only lead in economic dynamics but also in health challenges. Recent data reveals an escalating burden of Inflammatory Bowel Disease (IBD) in these nations. Understanding this trend is crucial to frame healthcare strategies and ensure the well-being of a significant portion of the global population. METHOD We employed data on IBD prevalence, incidence, mortality, and DALYs for G20 countries from the Global Burden of Disease (GBD) 2019 study. Using standardized statistical techniques, we analyzed by age, sex, year and location across G20 countries, estimating incidence and prevalence with the DisMod-MR 2.1 tool and mortality through the Cause of Death Ensemble Model (CODEm). RESULTS From 1990 to 2019, IBD prevalence figures in the G20 nations escalated from 2,999,730 (95%UI: 2,625,581-3,416,963) to 4,254,467 (3,809,445-4,751,041), marking a 42% (38-46) surge in the Annual Percentage Change (APC). Meanwhile, the incidence rose by 30% (26-35), mortality by 72% (49-97), and DALYs by 27% (15-43). Among these nations, China witnessed a striking 314% increase in incidence, closely followed by South Korea at 288%. Death rates were most pronounced in European Union members, with Portugal at the helm (441%), trailed by Italy (433%) and Germany (418%). Germany also led in DALYs growth with a 289% APC. Examining Age-standardized mortality rates, Germany again topped the list with a 244% increase, shadowed by Italy (186%) and the United States (147%). Over the past three decades, older populations demonstrated a rising IBD burden. In gender comparisons, males experienced a more significant incidence increase (32% vs. females at 28%) and DALYs (30% vs. females at 24%). Conversely, females had a steeper death rate growth, 77% as opposed to males at 67%. CONCLUSION In 2019, IBD was responsible for 2.02% of digestive disease-related deaths and 2.30% of associated disabilities in the G20 nations. The stark rise in IBD prevalence, especially in countries like China, South Korea, and European Union members, emphasizes a pressing need for targeted clinical approaches and proactive health policies to mitigate this escalating burden. Age-standardized rate (per 100,000 person years) of Inflammatory Bowel Disease in G20 Countries, 2019. A: ASIR, B: ASMR, C:ASDALR.
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Butler, Marcus O., Caroline Robert, Sylvie Negrier, Gino Kim In, John WT Walker, Ivana Krajsova, Victoria Atkinson, et al. "ILLUMINATE 301: A randomized phase 3 study of tilsotolimod in combination with ipilimumab compared with ipilimumab alone in patients with advanced melanoma following progression on or after anti-PD-1 therapy." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): TPS9599. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps9599.
Повний текст джерелаАнотація:
TPS9599 Background: Tilsotolimod (IMO-2125) is a Toll-like receptor (TLR) 9 agonist with potent immunostimulating activity. In an ongoing Phase 1/2 clinical study in patients with advanced melanoma who progressed on or after anti-PD-1 therapy (NCT02644967), intratumoral (IT) tilsotolimod with ipilimumab was well-tolerated, demonstrating durable responses (including complete response > 21 months), dendritic cell activation, type I interferon response, CD8+ T-cell proliferation in responders, and an abscopal effect. Methods: ILLUMINATE 301 (NCT03445533) is a randomized phase 3 global, multi-center, open-label study of IT tilsotolimod (8 mg) in combination with ipilimumab (3 mg/kg) versus ipilimumab monotherapy in patients with advanced melanoma and progression on or after anti-PD-1 therapy. Eligible patients are ≥18 years with histologically confirmed unresectable Stage III or Stage IV melanoma, ≥1 measurable lesion accessible for injection (superficial or visceral, the latter with image guidance), ECOG PS ≤1, and adequate organ function. Exclusion criteria include prior TLR agonists, prior ipilimumab (except adjuvant ≥12 weeks before progression), and CNS disease other than stable brain metastases. Patients are randomized 1:1 and stratified by duration of prior anti-PD-1 (≥12 weeks vs <12 weeks), stage (M1c vs other), and BRAF status/prior targeted therapy (TT) (BRAF wildtype vs BRAF mutation+ with TT vs BRAF mutation+ without TT). Primary endpoints are overall response rate (RECIST v1.1) by independent central review and overall survival. Secondary endpoints include durable response rate, time to response, progression-free survival, patient-reported outcomes, and safety. Patients are enrolling at sites in the United States, European Union, Australia, and Canada. References: (1) Haymaker C. Society for Immunotherapy of Cancer Annual Meeting, November 2017, National Harbor, MD; (2) Diab A, et al. European Society of Molecular Oncology Annual Meeting, October 2018, Munich, Germany. Clinical trial information: NCT03445533.
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Hossain, Arif. "Peace, Conflict and Resolution (Good vs. Evil) Part 2." Bangladesh Journal of Bioethics 4, no. 2 (September 9, 2013): 9–21. http://dx.doi.org/10.3329/bioethics.v4i2.16372.
Повний текст джерелаАнотація:
The immense structural inequalities of the global social /political economy can no longer be contained through consensual mechanisms of state control. The ruling classes have lost legitimacy; we are witnessing a breakdown of ruling-class hegemony on a world scale. There is good and evil among mankind; thus it necessitates the conflict between the good and evil on Earth. We are in for a period of major conflicts and great upheavals. It's generally regarded that Mencius (c.371-c.289 B.C) a student of Confucianism developed his entire philosophy from two basic propositions: the first, that Man's original nature is good; and the second, that Man's original nature becomes evil when his wishes are not fulfilled. What is good and what is evil? Philosophers of all ages have thought over this question. Each reckoned that he had solved the question once and for all, yet within a few years the problem would re-emerge with new dimensions. Repeated acts of corruption and evil action makes a man corrupt and takes away a man from his original nature. Still now majority of the people of the world give compliance to corruption because of social pressures, economic pressures, cultural pressures and political pressures. The conflict between good and evil is ancient on earth and is prevalent to this day. May be the final confrontation between the descendants of Cain and Abel is at our doorsteps. During the 2nd World War America with its European allies went into world wide military campaign to defeat Germany, Italy and Japan. When the Second World War ended in 1945 the United States of America came out as victorious. America was the first country to detonate atomic bomb in another country. During that period Russia fell into competition with America in politically colonizing countries after countries. With the fall of Communism Russia terminated its desire wanting to be the champion of the oppressed of the world. The situation in Russia continues to deteriorate, a country which until only a few years ago was a superpower. Russians are deeply disillusioned today with the new politicians in Russia, who they says "promise everything and give nothing." The Russians still strongly oppose a world order dominated by the United States. If anyone looks at or investigates the situations in other countries it can be seen that at present almost all countries of the world are similar or same in the forms of structures of corruption and evil. The Worldwide control of humanitys economic, social and political activities is under the helm of US corporate and military power. The US has established its control over 191 governments which are members of the United Nations. The last head of state of the former Soviet Union, Mikhail Gorbachev on December 2012, at a conference on the future of the Middle East and the Black Sea region in the Turkish city of Istanbul, has warned the US of an imminent Soviet-like collapse if Washington persists with its hegemonic policies. Mass public protest occurred against US hegemony are mainly from Muslim countries of South East Asia, South Asia, Central Asia, West Asia, North Africa and Africa. The latest mass protests erupted in September 2012 when the divine Prophet Muhammad (pbuh) was insulted by America and Israel. There were strong mass protests by people from Indonesia to Morocco and in the European countries by mostly immigrants and Australia were there are Muslim populations. This worldwide protest had occurred while the rise of the masses is ongoing against corrupt rulers in West Asia and North Africa. The masses of the people are thirsty and desperate for justice, dignity, economic welfare and human rights. Most major religions have their own sources of information on the Last Age of Mankind or the End of Times, which often include fateful battles between the forces of good and evil and cataclysmic natural disasters. Humans are evolving to a final stage of their evolution towards a ?New Age that is to come which the corrupt does not understand. At present times a final battle of good versus evil on Earth will ensue. The World powers (leaders) and their entourages who are really detached from the masses have organized to keep aloft the present world order that degenerates the masses in corruption, keeps the people in unhappiness, and deprives the masses from economic well being, education and keeps promoting wars and conflicts to support corruption and evil. We are at the ?End of Times?. The Promised Messiah will come to set right what is wrong, no doubt. DOI: http://dx.doi.org/10.3329/bioethics.v4i2.16372 Bangladesh Journal of Bioethics 2013; 4(2) 9-21
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Naujokaitis, Tadas, Ramin Khoramnia, Grzegorz Łabuz, Chul Young Choi, Gerd U. Auffarth, and Tamer Tandogan. "Imaging Function and Relative Light Transmission of Explanted Opacified Hydrophilic Acrylic Intraocular Lenses." Diagnostics 13, no. 10 (May 19, 2023): 1804. http://dx.doi.org/10.3390/diagnostics13101804.
Повний текст джерелаАнотація:
We evaluated the influence of intraocular lens (IOL) opacification on the optical performance of explanted hydrophilic acrylic IOLs. We performed a laboratory analysis of 32 Lentis LS-502-1 (Oculentis GmbH, Berlin, Germany) IOLs, explanted due to opacification, in comparison with six clear unused samples of the same IOL model. Using an optical bench setup, we obtained modulation transfer function (MTF), Strehl ratio, two-dimensional MTF, and United States Air Force (USAF) chart images. In addition, we assessed light transmission through the IOLs. The MTF values of opacified IOLs at 3-mm aperture were similar to those of clear lenses, with the median (interquartile range) values of 0.74 (0.01) vs. 0.76 (0.03) at the spatial frequency of 50 line pairs per millimeter in clear and opacified IOLs, respectively. The Strehl ratio of opacified lenses was not lower than that of clear lenses. The USAF-chart analysis showed a considerable reduction in brightness in opacified IOLs. The median (interquartile range) relative light transmission of opacified IOLs in comparison to clear lenses was 55.6% (20.8%) at the aperture size of 3 mm. In conclusion, the explanted opacified IOLs had comparable MTF values to those of clear lenses but significantly reduced light transmission.
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Peyrin-Biroulet, L., R. Ungaro, D. T. Rubin, B. Bokemeyer, E. Ricart, P. Levine, J. H. Lai, et al. "P683 Economic impact of achieving mucosal healing on UC-related hospitalisations and work productivity in patients with moderately to severely active UC: A post-hoc analysis of risankizumab Phase 2b/3 trials." Journal of Crohn's and Colitis 18, Supplement_1 (January 1, 2024): i1298—i1299. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0813.
Повний текст джерелаАнотація:
Abstract Background The value of endoscopic-histologic healing is incompletely understood, and definitions are variable. We assessed the clinical and economic value of achieving mucosal healing in patients with ulcerative colitis (UC) by evaluating the relationship of histologic-endoscopic mucosal improvement (HEMI) and subsequent UC-related hospitalisation and work productivity, and associated costs in the United States (US); United Kingdom (UK); and France, Germany, Italy, and Spain (EU4). Methods Data from the risankizumab (RZB) INSPIRE induction (NCT03398148) and COMMAND maintenance (NCT03398135) studies were analysed. The number of UC-related hospitalisations was compared in patients who achieved HEMI or no HEMI using a chi-square test. The mean percent changes in Work Productivity and Activity Impairment (WPAI)-UC domains from baseline to induction week 12 and maintenance week 52 were compared in patients who achieved HEMI or no HEMI using analysis of variance test. Hospitalisation and work productivity differences during induction and maintenance were converted to annualised costs based on average earnings and hospitalisation cost inputs from US, UK, and EU4. Results UC-related hospitalisations were significantly lower in patients who achieved HEMI at induction week 12 than those who did not (0% vs 2.9%, p≤0.05). A similar result was found at maintenance week 52, but the difference was not significant. In patients who achieved HEMI vs no HEMI, a greater mean change in activity impairment, impairment while working, and overall work impairment from baseline to induction week 12 was observed (p≤0.001). Improvements were sustained at maintenance week 52 for patients who achieved HEMI vs those who did not. Estimated annualised cost benefits from maintenance data for UC-related hospitalisations in patients who achieved HEMI was $490 in the US, £29 in the UK, and €28–€58 in EU4. Greater monetised benefits accrued from work productivity gains, where estimated annualised cost savings were $5,085 in the US, £3,507 in the UK, and €3,240–€4,456 in EU4. Conclusion These findings demonstrate that patients treated with RZB who achieved HEMI had fewer UC-related hospitalisations and greater improvement in work productivity and ability to perform daily activities than those who did not, which results in moderate direct cost savings and substantial indirect cost savings to healthcare systems in the US, UK, and EU4.
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Dick, Wolfgang F. "Anglo-American vs. Franco-German Emergency Medical Services System." Prehospital and Disaster Medicine 18, no. 1 (March 2003): 29–37. http://dx.doi.org/10.1017/s1049023x00000650.
Повний текст джерелаАнотація:
AbstractIt has been stated that the Franco-German Emergency Medical Services System (FGS) has considerable drawbacks compared to the Anglo-American Emergency Medical Services System (AAS):1. The key differences between the AAS and the FGS are that in the AAS, the patients is brought to the doctor, while in the FGS, the doctor is brought to the patient.2. In the FGS, patients with urgent conditions usually are evaluated and treated by general practitioners in their offices or at the patient`s home; initially, very few approach an emergency department.3. Emergency patients with life-threatening trauma or disease are treated by emergency physicians at the scene and during transport. Paramedics often are first to arrive at the scene, and until the emergency physician arrives at the scene, are allowed to defibrillate, to intubate endotracheal-ly, and to administer life-saving drugs (epinephrine endotracheally, glucose intravenously, etc.).4. Prehospital emergency physicians treat patients at the scene and during transport.5. Emergency patients are guaranteed to be reached by an appropriate emergency vehicle and a respective crew within 10 minutes in 80% of the responses and within 15 minutes in 95% of cases.6. The FGS deploys qualified emergency physicians assisted by qualified paramedics as prehospital intensive care providers; extended immediate care is standard. Total Prehospital Times (TPT) and scene times only are minimally longer than in the AAS.7. Emergency Medicine is recognized as a supra-specialty to the base specialties. Specific training programs exist for emergency physicians, medical directors of emergency medical services systems (EMSS), and chief emergency physicians (CEP).8. Resuscitation attempts are carried out not only by anesthesiologists, but also by internists, surgeons, pediatricians, etc. Emergency medicine encompasses cardiopulmonary resuscitation (CPR) and shock cases, and patients with an acute myocardial infarction, stroke, poly-trauma, status asthmaticus, etc. Emergency patients are admitted directly to emergency departments of the hospitals, which, depending upon the size of the hospital.9. The incidence of life-threatening trauma victims has decreased to <10% in the FGS. Of a total of 830,000 deaths/year, fatal trauma cases ranked the lowest at 4%.10. Survival figures on cardiac arrest (asystole, ventricular fibrillation/ventricular tachycardia (VF/VT), pulseless electrical activity (PEA), etc.) reported in the German EMSS correspond to those in Europe and the United States.11. Paramedic training is characterized by a two-year program followed by a theoretical and a practical examination.12. Paramedics and emergency physicians-in-training are supervised at the scene and during transport. Quality assurance (Q/A) constitutes an integral and legally compulsory part of the EMSS.13. In the majority of cases, the emergency patients are evaluated and treated by the respective specialties without delays caused by patient transfer to other hospitals.14. The FGS does not require a greater number of ambulances and/or personnel than does the AAS.15. The German healthcare system creates less expenses/ capita than the does the U.S. system at a similar level of quality of care.16. Emergency procedures are carried out by anesthesiologists, emergency physicians, surgeons, internists, and other specialists.
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Sikirica, M., J. Lynch, J. Kershaw, R. Lukanova, S. Baker, and G. Milligan. "P246 Persistent burden of disease in patients with Crohn’s disease treated with biologic therapy: results from a real-world survey in the United States (US), France, Germany, Italy, Spain, and United Kingdom (5EU)." Journal of Crohn's and Colitis 16, Supplement_1 (January 1, 2022): i292—i293. http://dx.doi.org/10.1093/ecco-jcc/jjab232.373.
Повний текст джерелаАнотація:
Abstract Background Crohn’s disease (CD) requires life-long disease management. The study objective was to investigate the burden of CD in patients who have only partially responded to biologic therapy. Methods Data were drawn from two waves (Nov 2014-Mar 2015; Sep 2017-Jan 2018) of the Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme™, a point-in-time survey of gastroenterologists (GEs) and their IBD patients, in the US, and 5EU. GEs completed a physician-reported questionnaire (PRF) for 5–10 consecutively consulting patients with CD, covering demographics, clinical characteristics, and health care resource use (HCRU). Same patients completed a voluntary patient-reported questionnaire (PSC) covering the Short IBD Questionnaire (SIBDQ), EuroQol 5-dimension (EQ-5D), and Work Productivity and Activity Impairment (WPAI) questionnaires. Crohn’s Disease Activity Index (CDAI) score, derived per patient from the PRF and PSC, was used to stratify patients into four groups by degree of disease activity (DA). Since clinical remission (CDAI <150) and moderate to severe (mod/sev) (≥221) are well known in clinical trials, we explored stratification in between, creating a ‘mild’ group (CDAI 150 - <180) and a ‘partial responder’ (PR) group (CDAI 180 - 220). Outcomes were compared between DA groups using linear regression (or logistic for binary outcome) that included the potential confounding variables age, gender, body mass index (BMI), comorbidities (using Charlson Comorbidity Index), and severity at diagnosis. From each regression, least square (LS) means were generated for each DA group and pairwise Wald tests were conducted to compare pairs of DA groups. Base sizes varied due to the voluntary PSC element. Results 319 GEs and 853 CD patients receiving a biologic for at least 12 weeks at data collection were included in the analysis (mean age 38.1 years, proportion of female patients 52.3%, 65.3% employed, mean BMI 24.1). CDAI groups are reported in Table 1. Levels of pain, sleep disturbance and fatigue were significantly lower in patients in remission (Table 2). SIBDQ, EQ-5D, and WPAI Health-Related Quality of Life (HrQoL) measures indicated significantly better outcomes amongst remission patients (Table 3). HCRU in the past 12 months, in terms of hospitalisations and surgery rates, was significantly lower amongst remission patients (Table 4). Conclusion Patients in remission showed significantly better outcomes compared with mild, PR and mod/sev. Patient stratification by CDAI demonstrated that patients in remission may considerably benefit from fewer symptoms and improved HrQoL, even vs ‘mild’ patients. The latter had unaddressed symptoms, which may negatively impact their wellbeing.
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Broughton, Edward I., Jürgen E. Gschwend, J. Alfred Witjes, Mia Berry, Michael Kostikas, Rachel Montgomery, Annabel Lambert, Siguroli Teitsson, and Neil Milloy. "Use of perioperative treatment (tx) among patients (pts) undergoing radical resection (RR) for muscle-invasive urothelial cancer (MIUC) in France, Germany, Italy, Spain, the United Kingdom, the United States, Canada, China, and Japan." Journal of Clinical Oncology 40, no. 6_suppl (February 20, 2022): 467. http://dx.doi.org/10.1200/jco.2022.40.6_suppl.467.
Повний текст джерелаАнотація:
467 Background: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by RR is the standard of care in cisplatin-eligible pts with MIUC. Adjuvant chemotherapy (AC) with cisplatin-based tx may be offered to those not given NAC. The unmet need this survey tried to evaluate is the post-RR burden of disease, quality of life (QoL) and perioperative tx patterns among MIUC pts. Methods: Real-world descriptive data were drawn from Adelphi’s MIUC Disease-Specific Programme: A point-in-time survey conducted with clinical/medical oncologists/urologists and their pts in 9 countries between January and June 2021. Physicians completed a survey on their pts’ clinical characteristics and tx patterns, while pts voluntarily completed a series of patient-reported outcome measures. Results: Of 2178 pts (data provided by 320 physicians), 30% received NAC only, 26% received AC only, 38% received no NAC or AC tx, and 6% received both. 1744 pts had initial tumour in the bladder; 35% received NAC only, 24% AC only, 35% no NAC or AC tx, and 6% received both. Of 387 pts with upper-tract urothelial carcinoma (UTUC), 51% received no NAC/AC tx, 35% received AC only, and 12% NAC only. More pts with T3 disease received no NAC/AC tx (36%) or NAC (35%) than AC (24%). Of 734 pts with nodal disease, 36% received NAC only. Of all pts, 60% experienced symptoms at data abstraction: 50% in pts who received NAC only, 71% in pts who received AC only and 82% in pts of those who received both. Pts reported similar EQ-5D-5L utility index scores (mean = 0.86; range: 0.84 [AC only] to 0.89 [NAC only]). Overall, feeling pain (40%) and stress (39%) were the EQ-5D domains with the worst scores. Pts who received AC only reported nominally lower EQ-5D visual analogue scale scores (71.11) compared with pts who received no NAC/AC (73.17) or pts who received NAC only (75.05). EORTC QLQ-C30 Global Health Status scores were 60.0 in pts who received AC only, 64.1 in pts who received NAC only or no NAC/AC, and 66.7 for pts who received both NAC and AC. Conclusions: Nearly 40% of pts remain untreated in either NAC or AC setting in 9 countries. A higher proportion of pts with UTUC go untreated. AC was more frequently used in UTUC vs BC pts; and in pts with Tis. NAC was implemented more frequently in pts T3 disease and in those with N+ disease. Pts who received AC appear to have nominally worse QOL and more symptoms, further demonstrating the need for efficacious adjuvant tx that does not decrease post-RR QoL.[Table: see text]
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Diel, Roland, and Niklas Lampenius. "Cost-benefit analysis of VKA versus NOAC treatment in German patients with atrial fibrillation utilizing patient self-testing." Journal of Health Economics and Outcomes Research 6, no. 3 (August 7, 2019): 142–59. http://dx.doi.org/10.36469/9774.
Повний текст джерелаАнотація:
Objectives: This study quantified the burden of hypoxic respiratory failure (HRF)/persistent pulmonary hypertension of newborn (PPHN) in preterm and term/near-term infants (T/NTs) by examining health care resource utilization (HRU) and charges in the United States. Methods: Preterms and T/NTs (≤34 and >34 weeks of gestation, respectively) having HRF/PPHN, with/without meconium aspiration in inpatient setting from January 1, 2011-October 31, 2015 were identified from the Vizient database (first hospitalization=index hospitalization). Comorbidities, treatments, HRU, and charges during index hospitalization were evaluated among preterms and T/NTs with HRF/PPHN. Logistic regression was performed to evaluate mortality-related factors. Results: This retrospective study included 504 preterms and 414 T/NTs with HRF/PPHN. Preterms were more likely to have respiratory distress syndrome, neonatal jaundice, and anemia of prematurity than T/NTs. Preterms had significantly longer inpatient stays (54.1 vs 29.0 days), time in a neonatal intensive care unit (34.1 vs 17.5 days), time on ventilation (4.7 vs 2.2 days), and higher total hospitalization charges ($613,350 vs $422,558) (all P<0.001). Similar rates were observed for use of antibiotics (96.2% vs 95.4%), sildenafil (9.5% vs 8.2%), or inhaled nitric oxide (93.8% vs 94.2%). Preterms had a significantly higher likelihood of mortality than T/NTs (odds ratio: 3.6, 95% confidence interval: 2.3-5.0). Conclusions: The findings of more severe comorbidities, higher HRU, hospitalization charges, and mortality in preterms than in T/NTs underscore the significant clinical and economic burden of HRF/PPHN among infants. The results show significant unmet medical need; further research is warranted to determine new treatments and real-world evidence for improved patient outcomes.
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Ijaz, M. Khalid, Raymond W. Nims, Sarah de Szalay, and Joseph R. Rubino. "Soap, water, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): an ancient handwashing strategy for preventing dissemination of a novel virus." PeerJ 9 (September 17, 2021): e12041. http://dx.doi.org/10.7717/peerj.12041.
Повний текст джерелаАнотація:
Public Health Agencies worldwide (World Health Organization, United States Centers for Disease Prevention & Control, Chinese Center for Disease Control and Prevention, European Centre for Disease Prevention and Control, etc.) are recommending hand washing with soap and water for preventing the dissemination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. In this review, we have discussed the mechanisms of decontamination by soap and water (involving both removal and inactivation), described the contribution of the various components of formulated soaps to performance as cleansers and to pathogen inactivation, explained why adherence to recommended contact times is critical, evaluated the possible contribution of water temperature to inactivation, discussed the advantages of antimicrobial soaps vs. basic soaps, discussed the differences between use of soap and water vs. alcohol-based hand sanitizers for hand decontamination, and evaluated the limitations and advantages of different methods of drying hands following washing. While the paper emphasizes data applicable to SARS-CoV-2, the topics discussed are germane to most emerging and re-emerging enveloped and non-enveloped viruses and many other pathogen types.
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Cella, D., M. D. Michaelson, J. C. Cappelleri, A. G. Bushmakin, C. Charbonneau, S. T. Kim, J. Z. Li та R. J. Motzer. "Quality of life (QOL) with sunitinib versus interferon-alfa (IFN-α) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): Final results". Journal of Clinical Oncology 27, № 15_suppl (20 травня 2009): 6529. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6529.
Повний текст джерелаАнотація:
6529 Background: In an international, randomized phase 3 trial (Figlin et al, ASCO. 2008), sunitinib showed superior progression-free survival (the primary endpoint) and objective response rate over IFN-α (11 vs. 5 mo and 47% vs. 12%, respectively; p < 0.000001) as first-line mRCC therapy, with a median overall survival of more than 2 years. Here, we report the final health-related QOL results from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib 50 mg orally once-daily in recurring cycles of 4 weeks on drug and 2 weeks off or IFN-α 9 MU subcutaneously thrice-weekly. QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G), which has 4 subscales, the FACT-Kidney Symptom Index-15 item (FKSI-15), which includes a Disease-Related Symptoms (FKSI-DRS) subscale, and the EQ-5D questionnaire's utility index (EQ-5D Index) and visual analog scale (EQ-VAS). The primary QOL endpoint was FKSI-DRS. Higher scores indicated better outcomes. Patients completed questionnaires on days 1 and 28 of each cycle. Data were analyzed for the intent-to-treat population using mixed-effects models (MM), supplemented with pattern-mixture models (PMM). We also compared QOL of patients in the United States (US) with patients in the European Union (EU; France, Germany, Italy, Poland, Spain and United Kingdom). Results: Patients on sunitinib reported better FKSI-15 and FKSI-DRS scores than those on IFN-α, with a significant difference in the overall means across cycles (4.06 and 2.36, respectively; p < 0.0001; MM). Similarly, differences in means for FACT-G (and all subscales), EQ-5D Index, and EQ-VAS all significantly favored sunitinib (p < 0.05). Based on pre-set, required minimum score differences, between-treatment differences in the mean scores were clinically meaningful for FKSI-15, FKSI-DRS, FACT-G, and the FACT-G functional well-being subscale. Between-treatment differences were similar for both the US and EU populations. Across all analyses, results from PMM were similar to those from MM. Conclusions: Sunitinib provides superior QOL over IFN-α, in addition to superior efficacy, as first-line mRCC therapy. [Table: see text]
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Corn, Tim, Peter Ogram, and Tina Doede. "Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome: Diagnostic Patterns Among United States and European Union Hematologists and Oncologists Managing Patients Receiving Stem Cell Transplantation." Blood 126, no. 23 (December 3, 2015): 4732. http://dx.doi.org/10.1182/blood.v126.23.4732.4732.
Повний текст джерелаАнотація:
Abstract Introduction Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially fatal complication of hematopoietic stem cell transplantation (HSCT) and high-dose chemotherapy. The VOD/SOS pathologic cascade is initiated by endothelial and hepatocyte damage. VOD/SOS is usually diagnosed using Baltimore criteria (≤21 days post transplant: bilirubin >2 mg/dL, plus 2 or more of hepatomegaly, ascites, and weight gain ≥5%) or modified Seattle criteria (≤20 days post transplant: 2 or more of bilirubin >2 mg/dL, hepatomegaly or right upper quadrant pain, and weight gain >2%). Severe VOD/SOS, usually characterized by multi-organ dysfunction (ie, pulmonary and/or renal dysfunction), may develop in a substantial number of high-risk patients and may be associated with >80% mortality. To understand the diagnostic patterns for VOD/SOS in the United States (US) and European Union (EU), a quantitative online survey was conducted among HSCT specialists. Methods Participating hematology-oncology specialists for pediatric and adult patients had ≥2 years direct involvement in performing HSCT, spent ≥25% of their time in direct patient care, and managed ≥10 HSCT patients (≥10 allogeneic) in the past year. Their facilities were accredited and performed ≥80 adult HSCT procedures in the US (≥50 in the EU) or ≥20 pediatric HSCT procedures (US or EU). In this survey, VOD/SOS severity was rated as early (milder) or severe (with multi-organ dysfunction). On average, the online survey took 30 to 40 minutes to complete. Results Surveys were completed by 100 US physicians (70 adult, 30 pediatric) and 153 EU physicians (122 adult, 31 pediatric; from France, Germany, Italy, Spain, and the United Kingdom). Each physician directly managed an average of 179 (US) or 95 (EU) HSCT patients in the past year. In adult patients, the median percentages of patients treated for severe/early VOD/SOS were 7%/7% in the US and 3%/6% in the EU; in pediatric patients, the median percentages were 9%/12% in the US and 5%/10% in the EU. The most commonly used VOD/SOS diagnostic signs and symptoms (Table) were weight gain and bilirubin level. The median level of weight gain to trigger follow-up action (action not specified but could include further diagnostic testing) was 10% in the US and 5% in the EU, for both adult and pediatric patients; the Baltimore and Seattle criteria specify a weight gain of 5% and 2%, respectively. US physicians were less likely than EU physicians to take action at weight gain of ≤5% (Figure): about half as likely for adults (29% vs 56%) and about a fifth as likely for pediatric patients (14% vs 67%). In addition, at ≤5% weight gain, US physicians of pediatric patients were about twice as likely to take action as US physicians of adult patients. The median bilirubin levels at which US physicians initiated action were 3 mg/dL in adults and 4 mg/dL in pediatric patients, compared with 2 mg/dL for EU physicians in both adult and pediatric patients (Figure); the Baltimore and modified Seattle criteria specify a bilirubin level of 2 mg/dL. Conclusions The survey results show that a substantial proportion of US HSCT physicians take follow-up action at weight gain or bilirubin thresholds higher than those in the Baltimore or modified Seattle criteria. Treatment patterns in the EU, particularly among pediatric physicians, appear to be more closely aligned with the diagnostic criteria. The established criteria have limitations; neither set takes into account late onset of VOD/SOS or presentation of edema and weight gain in the absence of other signs and symptoms. As discussed in a recent publication (Mohty M et al. BMT. 2015;50[6]:781-789), elevated bilirubin may be absent in VOD/SOS developing late after HSCT and in children, which prompted the authors to suggest the need for a criteria update. Support: Jazz Pharmaceuticals. Participants received financial remuneration for their survey participation. Table. VOD/SOS Assessment Measures Used by Physicians Baltimore/Seattle Item US(n=95), % EU(n=152), % Weight increase Y 50 78* Bilirubin increase Y 46 62* Hepatomegaly Y 36 57* Ascites Y 36 49* Ultrasound 27 47* Liver Doppler 23 29 Pain Y 16 29* Jaundice Y 25 28 Liver function Y 25 26 Distention/Swelling Y 22 18 *P <.05 vs US. Figure 1. Figure 1. Disclosures Corn: Jazz Pharmaceuticals: Employment, Equity Ownership. Ogram:Jazz Pharmaceuticals: Employment, Equity Ownership. Doede:Jazz Pharmaceuticals: Employment, Equity Ownership.
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Gottschalk, Zachary, Mary Weber Redman, Kelsey K. Baker, Cornelia M. Ulrich, Erin M. Siegel, Jane C. Figueiredo, David Shibata, et al. "Comparison of the disease presentation of early- vs. later-onset colorectal cancer within the prospective ColoCare study." Journal of Clinical Oncology 42, no. 3_suppl (January 20, 2024): 91. http://dx.doi.org/10.1200/jco.2024.42.3_suppl.91.
Повний текст джерелаАнотація:
91 Background: Within the United States (US), colorectal cancer (CRC) is the third most diagnosed cancer and the second leading cause of cancer-related fatalities, with a median age at diagnosis of 66 years. While the incidence of sporadic CRC is decreasing, the incidence in those aged 18-49 years has steadily increased. Younger patients are not often screened for CRC, and they are often diagnosed at a later stage of disease. Herein, we compare the presenting symptoms and stage at diagnosis of early-onset CRC to disease in those aged 50 or greater. Methods: The ColoCare Study is a prospective cohort enrolling individuals diagnosed with primary CRC across six cancer centers in the US and one site in Germany. Serial questionnaires administered at baseline assessed demographic characteristics and symptoms experienced prior to diagnosis, while clinical data such as staging and pathology were abstracted from medical records. For this analysis, only patients who had available age and tumor stage were included. Patients diagnosed <50 years old were categorized as “early-onset” and ≥50 as “later-onset.” Fisher’s exact test was used to compare demographics, disease state characteristics, and symptoms experienced by age group. Statistical significance was based on a two-sided alpha level of 0.05. Results: 1,996 patients were included in this analysis. Of these, 1,508 (76%) were later-onset (mean diagnosis age 64, range: 50-94), while 488 (24%) were early-onset (mean age: 42, range: 21-49). Demographic data was similar between early- and later-onset patients in terms of gender and primary site. Disease stage at diagnosis was significantly associated with age (p < 0.001). A higher proportion of early-onset patients had advanced disease at the time of diagnosis compared to later-onset for both stage III (43% vs 37%) and stage IV disease (28% vs 17%). For patients with available histologic data, younger patients were more likely to have vascular (35% vs 28%, p=0.03) and perineural invasion (33% vs 21%, p <0.001) at diagnosis. Early-onset patients were also more likely to report symptoms prior to diagnosis (95% vs 83%, p <0.001). Specifically, younger patients reported higher rates of abdominal pain (46% vs 23%, p < 0.001), blood in stool (71% vs 54%, p <0.001), and changes in bowel habits (54% vs 40%, p <0.001). General weakness and vomiting were also statistically more likely to be noted at presentation in early-onset patients. Conclusions: In this prospective real-world cohort analysis, patients with early-onset CRC are more likely to be diagnosed with more advanced disease at presentation than later-onset patients. This analysis highlights key symptoms that should raise awareness as possible indicators of a new diagnosis of CRC, even in individuals <50 years old. Additional disease comparisons between age groups will be presented at the meeting.
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Eichenbaum, PhD, Gary, Karin Göhler, MD, Mila Etropolski, MD, Ilona Steigerwald, MD, PhD, Joseph Pergolizzi, MD, Myoung Kim, PhD, MA, and Gary Vorsanger, PhD, MD. "Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency." Journal of Opioid Management 11, no. 3 (May 1, 2015): 211. http://dx.doi.org/10.5055/jom.2015.0270.
Повний текст джерелаАнотація:
Objectives: Opioid-induced androgen deficiency (OPIAD) affects patients treated with opioid analgesics. The norepinephrine reuptake inhibitor (NRI) and μ-opioid receptor (MOR) agonist activities of tapentadol may result in tapentadol having less effect on serum androgen concentrations than analgesics acting through the MOR alone, such as morphine and oxycodone. The objectives of this publication are to 1) evaluate the effects of tapentadol (NUCYNTA and NUCYNTA extended release [ER]) on sex hormone concentrations in healthy male volunteers (vs placebo and morphine) and patients with osteoarthritis (vs placebo and oxycodone), and 2) present a mechanistic hypothesis explaining how the combined MOR agonist and NRI activities of tapentadol may result in less impact on androgen concentrations. Methods: Three clinical studies were conducted: study 1 (single-dose comparison study vs morphine in healthy volunteers), study 2 (single-dose-escalation study in healthy volunteers without an active comparator), and study 3 (multiple-dose study vs oxycodone in patients with osteoarthritis). Studies 1 and 2 were conducted at medical research centers in Germany and the United Kingdom; study 3 was conducted at primary and secondary care centers and medical research centers in the United States. All three studies were randomized, double blind, and placebo controlled. Concentrations of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH; study 3 only) were evaluated at 6 and 24 hours postdose in studies 1 and 2, respectively, and at varying time points postdose in study 3.Results: In study 1, mean serum total testosterone concentrations in healthy male volunteers were similar at baseline for all treatment periods; 6 hours after dosing, mean concentrations were comparable between placebo (8.6 nmol/L) and tapentadol immediate release (IR; 43 mg, 8.8 nmol/L; 86 mg, 9.3 nmol/L), but were lower following administration of morphine IR 30 mg (5.4 nmol/L). In study 2, there were no or minimal changes in testosterone in the therapeutic dose range with tapentadol IR (75-100 mg), and there was a modest decrease that appeared to level off in the supratherapeutic range (125-175 mg); mean testosterone and LH concentrations with all doses remained within normal ranges (testosterone, 4.56-28.2 nmol/L; LH, 2.9-4.6 U/L). In study 3, the decrease in the mean [standard deviation] testosterone concentration from baseline to endpoint for male patients receiving tapentadol ER (100 mg, −1.9 [0.71] nmol/L; 200 mg, −2.1 [0.93] nmol/L) was numerically smaller compared to oxycodone CR (20 mg, −2.7 [0.93] nmol/L), but higher compared to placebo (−0.3 [1.62] nmol/L).Conclusions: These results suggest that tapentadol, which has combined MOR and NRI activities, may have a lower impact on sex hormone concentrations than pure opioid analgesics, such as morphine or oxycodone. The data and mechanistic rationale presented herein provide a justification for conducting additional hypothesis testing studies, and are not intended to be used as a basis for clinical decision making. Future studies may help elucidate whether the observed trends are clinically significant and would translate into a reduced incidence of OPIAD.
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Corker, Katherine S., Jack D. Arnal, Diane B. V. Bonfiglio, Paul G. Curran, Christopher R. Chartier, William J. Chopik, Rosanna E. Guadagno, Amanda M. Kimbrough, Kathleen Schmidt, and Bradford J. Wiggins. "Many Labs 5: Registered Replication of Albarracín et al. (2008), Experiment 7." Advances in Methods and Practices in Psychological Science 3, no. 3 (September 2020): 340–52. http://dx.doi.org/10.1177/2515245920925750.
Повний текст джерелаАнотація:
Albarracín et al. (2008, Experiment 7) tested whether priming action or inaction goals (vs. no goal) and then satisfying those goals (vs. not satisfying them) would be associated with subsequent cognitive responding. They hypothesized and found that priming action or inaction goals that were not satisfied resulted in greater or lesser responding, respectively, compared with not priming goals ( N = 98). Sonnleitner and Voracek (2015) attempted to directly replicate Albarracín et al.’s (2008) study with German participants ( N = 105). They did not find evidence for the 3 × 2 interaction or the expected main effect of task type. The current study attempted to directly replicate Albarracín et al. (2008), Experiment 7, with a larger sample of participants ( N = 1,690) from seven colleges and universities in the United States. We also extended the study design by using a scrambled-sentence task to prime goals instead of the original task of completing word fragments, allowing us to test whether study protocol moderated any effects of interest. We did not detect moderation by protocol in the full 3 × 2 × 2 design (pseudo- r2 = 0.05%). Results for both protocols were largely consistent with Sonnleitner and Voracek’s findings (pseudo- r2s = 0.14% and 0.50%). We consider these results in light of recent findings concerning priming methods and discuss the robustness of action-/inaction-goal priming to the implementation of different protocols in this particular context.
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Benito-Garcia, Elizabeth, Julio Vega, Eric J. Daza, Wei-Nchih Lee, Adee Kennedy, and Jean-Marc Chantelot. "Patient and Physician Perspectives on the Use of a Connected Ecosystem for Diabetes Management: International Cross-Sectional Observational Study." JMIR Formative Research 7 (November 30, 2023): e47145. http://dx.doi.org/10.2196/47145.
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Background Collaboration between people with type 2 diabetes (T2DM) and their health care teams is important for optimal control of the disease and outcomes. Digital technologies could potentially tie together several health care-related devices and platforms into connected ecosystems (CES), but attitudes about CES are unknown. Objective We surveyed convenience samples of patients and physicians to better understand which patient characteristics are associated with higher likelihoods of (1) participating in a potential CES program, as self-reported by patients with T2DM and (2) clinical benefit from participation in a potential CES program, as reported by physicians. Methods Adults self-reporting a diagnosis of T2DM and current insulin use (n=197), and 33 physicians whose practices included ≥20% of such patients, were enrolled in the United States, France, and Germany. We surveyed both groups about the likelihood of patient participation in a CES. We then examined the associations between patients’ clinical and sociodemographic characteristics and this likelihood. We also described characteristics of patients likely to clinically benefit from CES use, according to physicians. Results Compared with patients in Germany and France, US patients were younger (mean age 45.3 [SD 11.9] years vs 61.9 [SD 9.2] and 65.8 [SD 9.4] years, respectively), more often female, more highly educated, and more often working full-time. In all, 51 (44.7%) US patients, 16 (36.4%) German patients, and 18 (46.3%) French patients indicated strong interest in a CES program, and 115 (78.7%) reported currently using ≥1 connected device or app. However, physicians believed that only 11.3%-19.2% of their patients were using connected devices or apps to manage their disease. Physicians also reported infrequently recommending or prescribing connected devices to their patients, although ≥80% (n=28) of them thought that a CES could help support their patients in managing their disease. The factors most predictive of patient likelihood of participating in a CES program were cost, inclusion of medication reminders, and linking blood glucose levels to behaviors such as eating and exercise. In all countries, the most common patient expectations for a CES program were that it could help them eat more healthfully, increase their physical activity, increase their understanding of how blood glucose relates to behavior such as exercise and eating, and reduce stress. Physicians thought that newly diagnosed patients, sicker patients—those who had been hospitalized for diabetes, were currently using insulin, or who had any comorbid condition—and patients who were nonadherent to treatment were most likely to benefit from CES use. Conclusions In this study, there was a high degree of interest in the future use of CES, although additional education is needed among both patients with T2DM and their physicians to achieve the full potential of such systems to improve self-management and clinical care for the disease.
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Altmann, Samuel, Luke Milsom, Hannah Zillessen, Raffaele Blasone, Frederic Gerdon, Ruben Bach, Frauke Kreuter, Daniele Nosenzo, Séverine Toussaert, and Johannes Abeler. "Acceptability of App-Based Contact Tracing for COVID-19: Cross-Country Survey Study." JMIR mHealth and uHealth 8, no. 8 (August 28, 2020): e19857. http://dx.doi.org/10.2196/19857.
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Background The COVID-19 pandemic is the greatest public health crisis of the last 100 years. Countries have responded with various levels of lockdown to save lives and stop health systems from being overwhelmed. At the same time, lockdowns entail large socioeconomic costs. One exit strategy under consideration is a mobile phone app that traces the close contacts of those infected with COVID-19. Recent research has demonstrated the theoretical effectiveness of this solution in different disease settings. However, concerns have been raised about such apps because of the potential privacy implications. This could limit the acceptability of app-based contact tracing in the general population. As the effectiveness of this approach increases strongly with app uptake, it is crucial to understand public support for this intervention. Objective The objective of this study is to investigate the user acceptability of a contact-tracing app in five countries hit by the pandemic. Methods We conducted a largescale, multicountry study (N=5995) to measure public support for the digital contact tracing of COVID-19 infections. We ran anonymous online surveys in France, Germany, Italy, the United Kingdom, and the United States. We measured intentions to use a contact-tracing app across different installation regimes (voluntary installation vs automatic installation by mobile phone providers) and studied how these intentions vary across individuals and countries. Results We found strong support for the app under both regimes, in all countries, across all subgroups of the population, and irrespective of regional-level COVID-19 mortality rates. We investigated the main factors that may hinder or facilitate uptake and found that concerns about cybersecurity and privacy, together with a lack of trust in the government, are the main barriers to adoption. Conclusions Epidemiological evidence shows that app-based contact tracing can suppress the spread of COVID-19 if a high enough proportion of the population uses the app and that it can still reduce the number of infections if uptake is moderate. Our findings show that the willingness to install the app is very high. The available evidence suggests that app-based contact tracing may be a viable approach to control the diffusion of COVID-19.
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Pfeuffer, Steffen, Leoni Rolfes, Jens Ingwersen, Refik Pul, Konstanze Kleinschnitz, Melanie Korsen, Saskia Räuber, et al. "Effect of Previous Disease-Modifying Therapy on Treatment Effectiveness for Patients Treated With Ocrelizumab." Neurology - Neuroimmunology Neuroinflammation 10, no. 3 (April 11, 2023): e200104. http://dx.doi.org/10.1212/nxi.0000000000200104.
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Background and ObjectivesB cell–depleting antibodies were proven as effective strategy for the treatment of relapsing multiple sclerosis (RMS). The monoclonal antibody ocrelizumab was approved in 2017 in the United States and in 2018 in the European Union, but despite proven efficacy in randomized, controlled clinical trials, its effectiveness in the real-world setting remains to be fully elucidated. In particular, most study patients were treatment naive or switched from injectable therapies, whereas oral substances or monoclonal antibodies made up >1% of previous treatments.MethodsWe evaluated ocrelizumab-treated patients with RMS enrolled in the prospective cohorts at the University Hospitals Duesseldorf and Essen, Germany. Epidemiologic data at baseline were compared, and Cox proportional hazard models were applied to evaluate outcomes.ResultsTwo hundred eighty patients were included (median age: 37 years, 35% male patients). Compared with using ocrelizumab as a first-line treatment, its use as a third-line therapy increased hazard ratios (HRs) for relapse and disability progression, whereas differences between first- vs second-line and second- vs third-line remained smaller. We stratified patients according to their last previous disease-modifying treatment and here identified fingolimod (FTY) (45 patients, median age 40 years, 33% male patients) as a relevant risk factor for ongoing relapse activity despite 2nd-line (HR: 3.417 [1.007–11.600]) or 3rd-line (HR: 5.903 [2.489–13.999]) ocrelizumab treatment, disability worsening (2nd line: HR: 3.571 [1.013–12.589]; 3rd line: HR: 4.502 [1.728–11.729]), and occurrence of new/enlarging MRI lesions (2nd line: HR: 1.939 [0.604–6.228]; 3rd line: HR: 4.627 [1.982–10.802]). Effects were persistent throughout the whole follow-up. Neither peripheral B-cell repopulation nor immunoglobulin G levels were associated with rekindling disease activity.DiscussionOur prospectively collected observational data suggest suboptimal effectiveness of ocrelizumab in patients switching from FTY compared with those switching from other substances or having been treatment naive. These findings support previous studies indicating abated effectiveness of immune cell–depleting therapies following FTY treatment in patients with RMS.Classification of EvidenceThis study provides Class IV evidence that for patients with RMS, previous treatment with FTY compared with previous treatment with other immunomodulating therapies decreases the effectiveness of ocrelizumab.
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Gribben, John G., Emmanuel Bachy, Markqayne Ray, Kathryn Krupsky, Kathleen Beusterien, Lewis Kopenhafer, Flor Mendez, et al. "Physician Treatment Preferences in Relapsed/Refractory Follicular Lymphoma: A Discrete Choice Experiment." Blood 142, Supplement 1 (November 28, 2023): 4424. http://dx.doi.org/10.1182/blood-2023-190261.
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Introduction: Follicular lymphoma (FL) is an indolent form of non-Hodgkin lymphoma with limited treatment options at disease progression. Novel treatments, like bispecific antibodies and chimeric antigen receptor T-cell therapy, have recently emerged, each with novel safety and management profiles. Yet, contemporary research evaluating treatment preferences among physicians treating relapsed or refractory (r/r) FL is lacking. The objective of this study was to identify key treatment attributes that influence physicians' treatment decisions when treating patients with r/r FL. Methods: We fielded a multi-country survey of physicians from the United States (US), United Kingdom (UK), Brazil, Japan, Germany and France, with up to 50 participants in each country. Data collected as of June 13, 2023 are reported with the remaining data from all countries expected by July 31st. Physicians were recruited through a healthcare research panel for an online, cross-sectional survey that included two discrete choice experiment (DCE) exercises: one for 2 nd line (2L) and one for 3 rd line (3L) therapy. The DCEs prompted physicians to choose between 2 treatment profiles that varied on 7 attributes associated with treatment for r/r FL: progression-free survival (PFS), overall survival (OS), serious adverse events (AE), cytokine release syndrome (CRS) events, neurological events, fatigue and administration/impact on functioning. Attributes and levels of interest were informed by a targeted literature review, clinical data on r/r FL treatments and clinical input. Sociodemographic and practice characteristics were summarized using descriptive statistics. We generated attribute level preference weights using hierarchical Bayesian modeling. Relative attribute importance (RI) was computed based on differences in preference weights between the most and least favorable level of each attribute. Bivariate statistics were used to evaluate differences between physicians. Interim results from the UK and US are reported with plans to include additional countries at time of presentation. Results: This analysis included 98 physicians (49 US; 49 UK) who averaged 13.7 years treating patients with FL. Most physicians specialized in medical oncology or hematology oncology (US: 100.0%; UK: 83.7%). Overall, 55.1% of physicians practiced in academic settings whereas 44.9% practiced in community settings; the proportion of academic-based physicians was higher in the UK vs the US (79.6% vs 30.6%; p<0.001). Roughly 60% of patients managed by physicians were >50 years of age. The mean number of FL patients treated over the past six months among physicians from the UK was greater than physicians from the US [65.0 vs 43.0, respectively]. Yet, the mean proportion of patients receiving 2L and 3L therapy over the past six months was roughly equal between physicians from the US and UK [2L: 27.2% vs 26.1%; 3L: 15.9% vs 15.6%]. In the context of 2L (Figure 1) and 3L (Figure 2) therapy, improved PFS was selected as most important (2L RI=20.4%; 3L RI=27.5%) whereas reducing the risk of serious AEs was least important (2L=5.6%; 3L RI=6.7%). In 2L, reducing the risk of neurological events was the second most important attribute (RI=19.1%) followed by increasing OS (RI=16.2%). Conversely, in 3L therapy, increasing OS was the second most important attribute (RI=18.9%) followed by reducing the risk of neurological events (RI=14.3%). Reducing the risk of neurological events and the risk of CRS were relatively more important to physicians in the 2L vs 3L setting. In general, physicians from the US and UK assigned similar levels of importance to each attribute evaluated, regardless of treatment line. However, the RI of fatigue was higher among physicians from the UK compared to those from the US (13.5% vs. 10.0%; p=0.047). Conclusion: Assessing physician treatment preference facilitates alignment between what matters most to patients and physicians' treatment decisions in r/r FL, particularly amidst an evolving treatment landscape. PFS was the most important attribute influencing physicians' treatment decisions for patients in 2L and 3L settings, which suggests that preserving a longer treatment-free period is important to physicians at both lines of therapy. Future treatments for r/r FL may need to demonstrate PFS benefits to influence physicians' willingness to make trade-offs between efficacy and side effects in earlier treatment lines.
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Schildhaus, Hans-Ulrich, Sunil Badve, Corrado D’Arrigo, Gelareh Farshid, Annette Lebeau, Vicente Peg, Fréderique Penault-Llorca, et al. "Abstract 1030: Concordance between the DESTINY-Breast04 clinical trial assay (4B5[CDx]) and other HER2 IHC assays for HER2-low breast cancer in real-world practice: First phase of a large-scale, multicenter global ring study." Cancer Research 84, no. 6_Supplement (March 22, 2024): 1030. http://dx.doi.org/10.1158/1538-7445.am2024-1030.
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Abstract Background: DESTINY-Breast04 (DB-04) showed that trastuzumab deruxtecan improves survival vs chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry [IHC] 1+ or IHC 2+ with in situ hybridization negative) metastatic breast cancer (BC). The VENTANA 4B5(CDx) IHC assay, now approved in the United States (US) as a companion diagnostic, was used as the clinical trial assay (CTA) in DB-04. Real-world differentiation of HER2-low vs HER2 IHC 0 BC with non-CTAs is difficult. This is the first phase of a study assessing agreement between CTA and non-CTA scores. Methods: 50 clinical BC samples with HER2 IHC scores of 0, 1+, 2+, and 3+ were sent to laboratories in Europe, Canada, and the US for HER2 IHC testing per ASCO/CAP 2018 guidelines. After routine protocol scoring, pathologists were trained and rescored the samples 2 weeks later. Post training scores were compared with reference CTA scores determined by a central laboratory and a panel of experts. The primary endpoint was positive percentage agreement (PPA) and negative percentage agreement (NPA) between CTA and non-CTA scores, assessed after training, considering HER2-low as positive and HER2 IHC 0 as negative. Results: A total of 3449 post training non-CTA scores were available for analysis. PPA for HER2-low vs HER2 IHC 0 was 87.5% and NPA was 61.9%, with Cohen κ of 0.51 (Table). HER2-low vs HER2 IHC 0 agreement between CTA and non-CTA varied across subgroups. PPA >95% was shown with 4B5 Laboratory Developed Tests (LDTs) and HercepTest (Omnis), NPA of 80% with Leica, and overall agreement >80% with HercepTest (Link48), 4B5 LDTs, and German, French, and Italian laboratories. Conclusions: The degree of concordance between the CTA and non-CTAs varied among assay types and laboratory locations. A low NPA for some non-CTAs suggests the need for further assay optimization for HER2 IHC 0 evaluation. Post training non-CTA results HER2-low vs HER2 IHC 0 BC Post training scores PPA (95% CI), % NPA (95% CI), % Overall percentage agreement (95% CI), % Cohen κ (95% CI) Overall non-CTA test results (N = 3449) 87.5 (86.0-89.0) 61.9 (58.9-64.9) 78.7 (77.1-80.1) 0.51 (0.48-0.54) Non-CTA subgroups HercepTest (Omnis) (n = 467) 95.5 (92.3-97.7) 36.9 (28.9-45.4) 75.2 (70.8-79.4) 0.37 (0.28-0.46) HercepTest (Link48) (n = 790) 88.5 (85.2-91.2) 64.3 (57.8-70.4) 80.3 (77.2-83.2) 0.55 (0.48-0.61) Leica (n = 96) 59.3 (45.0-72.4) 80.0 (61.4-92.3) 66.7 (55.5-76.6) 0.35 (0.17-0.53) Non-4B5 LDTs (n = 1609) 83.8 (81.2-86.1) 67.8 (63.5-72.0) 78.2 (75.9-80.3) 0.52 (0.47-0.57) 4B5 LDTs (n = 487) 96.0 (93.0-98.0) 58.8 (50.4-66.8) 83.0 (79.1-86.4) 0.59 (0.51-0.68) Country subgroups Germany (n = 340) 93.1 (88.5-96.3) 64.4 (54.2-73.6) 83.1 (78.3-87.2) 0.61 (0.51-0.70) France (n = 342) 95.4 (91.5-97.9) 64.4 (54.4-73.6) 84.7 (80.1-88.6) 0.64 (0.55-0.73) Italy (n = 395) 89.9 (85.2-93.5) 72.5 (63.6-80.3) 83.9 (79.6-87.6) 0.64 (0.55-0.72) Spain (n = 567) 83.0 (78.4-86.9) 64.2 (56.6-71.3) 76.3 (72.3-80.0) 0.48 (0.40-0.56) US/Canada (n = 1029) 86.6 (83.6-89.2) 61.8 (56.1-67.3) 78.2 (75.4-80.8) 0.50 (0.44-0.56) Europe, other (n = 776) 85.0 (81.3-88.2) 52.8 (46.2-59.3) 73.8 (70.3-77.1) 0.40 (0.32-0.47) Citation Format: Hans-Ulrich Schildhaus, Sunil Badve, Corrado D’Arrigo, Gelareh Farshid, Annette Lebeau, Vicente Peg, Fréderique Penault-Llorca, Josef Rueschoff, Wentao Yang, Neil Atkey, Jessica Baumann, Elisabeth Beyerlein, Amy Hanlon Newell, Alexander Penner, Akira Moh, Guiseppe Viale. Concordance between the DESTINY-Breast04 clinical trial assay (4B5[CDx]) and other HER2 IHC assays for HER2-low breast cancer in real-world practice: First phase of a large-scale, multicenter global ring study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1030.
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Rollison, Dana E., Matthew Hayat, Martyn Smith, Sara S. Strom, William D. Merritt, Lynn Ries, Brenda K. Edwards, and Alan F. List. "First Report of National Estimates of the Incidence of Myelodysplastic Syndromes and Chronic Myeloproliferative Disorders from the U.S. SEER Program." Blood 108, no. 11 (November 16, 2006): 247. http://dx.doi.org/10.1182/blood.v108.11.247.247.
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Abstract BACKGROUND: Incidence rates for myelodysplastic syndromes (MDS) and chronic myeloproliferative disorders (CMD) in the United States were unavailable prior to the addition of these stem cell malignancies to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program and other central cancer registries in 2001. Description of national incidence rates for 2001–2003 will provide an important baseline for future studies of secular trends and allow for the examination of rates by selected demographic factors to define risk profiles of these malignancies in the American population. METHODS: Incidence rates of MDS and CMD were calculated for 18 SEER areas between 2001–2003. These rates were stratified by disease subtype using the FAB classification (including chronic myelomonocytic leukemia [CMML]) with the addition of the WHO deletion 5q category, sex, age at diagnosis and race. Based on the observed SEER incidence rates, counts were estimated for the entire U.S. population. RESULTS: In 2003, 2,538 cases of MDS and 1,421 cases of CMD were observed for all 18 SEER areas combined. Similar numbers of cases were observed in 2001 and 2002. Age-adjusted incidence rates for 2001–2003 were significantly higher among males than females for MDS (4.5 per 100,000 in males vs. 2.7 per 100,000 in females, p <0.0001) and CMD (2.4 per 100,000 in males vs. 1.7 per 100,000 in females, p<0.0001). This gender rate difference was observed consistently across all disease subtypes, including refractory anemia (2.0 per 100,000 in males vs. 1.2 per 100,000 in females (p<0.0001). Incidence rates were significantly associated with age at diagnosis for both MDS (p=0.01) and CMD (p=0.001), and were highest among White, non-Hispanics (2.4 per 100,000 for CMD; 4.2 per 100,000 for MDS). An estimated national total of 14,648 cases of MDS (including CMML) and CMD were diagnosed in 2003, with overall incidence rates for MDS and CMD of 3.1 and 1.9 per 100,000, respectively. The MDS incidence rate for the U.S. is remarkably similar to those previously reported from European countries including England and Wales (3.6 per 100,000), Germany (4.1 per 100,000), Sweden (3.6 per 100,000) and France (3.2 per 100,000). Estimated incidence rates in the U.S. were greater among men than women for all diseases, including CMML (0.40 per 100,000 in males versus 0.3 per 100,000 in females, p< 0.0001). Disease incidence increased with age for MDS, CMD, and CMML, although the increase was greatest for MDS, with an approximate five-fold difference in estimated rates for those diagnosed at ages 60–69 years vs. 80 years and older (7.4 per 100,000 vs. 36.3 per 100,000). The increase in MDS incidence with age was greater for males than females, whereas the age-related increase in CMD and CMML incidence was similar across sexes. Rates of CMD, MDS and CMML were all estimated to be highest among White, non-Hispanics. CONCLUSION: Male sex and advanced age are important risk factors for the development of CMD and MDS. Diagnostic recording differences may underestimate the total annual U.S. MDS and CMD case burden. Future prevention intervention and disease causality studies of MDS and CMD should target high-risk groups.
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Dubinsky, M. C., T. Gibble, S. Travis, R. Panaccione, T. Hibi, A. P. Bleakman, T. Panni, et al. "DOP70 Prevalence and severity of bowel urgency in Crohn’s Disease: Results from the Communicating Needs and Features of IBD Experience (CONFIDE) Survey." Journal of Crohn's and Colitis 18, Supplement_1 (January 1, 2024): i201—i202. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0110.
Повний текст джерелаАнотація:
Abstract Background Bowel urgency (BU) affects patients with Crohn’s disease (CD); however, its prevalence and severity are unclear. Here, data from Communicating Needs and Features of IBD Experiences (CONFIDE) study were used to understand the burden and impact of BU among patients with moderate-to-severe CD. Methods CONFIDE is an online, quantitative, cross-sectional survey exploring the experiences and impact of symptoms on patients with CD or ulcerative colitis in Europe (France, Germany, Italy, Spain, and UK), United States (US) and Japan. Criteria based on previous treatment, steroid use, and/or hospitalization defined moderate-to-severe CD. Patients were asked about bowel movement deferral time with response options ranging from able to wait ≥15 minutes (mins) to sometimes unable to make it to the bathroom in time. Patients currently experiencing BU (in last month) rated BU severity in the last 3 days using the Urgency Numeric Rating Scale (NRS, 0-10), a content-validated patient-reported instrument. CD data from Europe and US are presented here using descriptive statistics. Results Surveys were completed by 547 European (male [M]=55.4%, mean age 38 years) and 215 US (M=54.9%, mean age 40.9 years) patients with CD. Current BU (over the past month) was reported by 38% of patients in Europe and 42.3% in US. More than one-third of all patients in both Europe and US reported that over the last 3 days, they needed to get to the bathroom within 5 mins, and 1.8% European and 2.8% US patients were sometimes unable to make it to the bathroom in time. Among patients who reported currently experiencing BU, 46% reported the need to get to the bathroom within 5 mins and 3% reported sometimes being unable to make it to the bathroom in time in both Europe and US. Shorter deferral times were reported by those with higher mean Urgency NRS scores (Table). Mean (SD) Urgency NRS scores in patients with a deferral time <5 mins vs those with a deferral time >5 mins were 7.0 (1.7) vs 6.5 (2.1) among European and 7.3 (1.5) vs 6.7 (1.9) among the US patients. Most European and US patients reported experiencing BU, BU-related accidents, and/or wearing diaper/pad/other protection due to fear/anticipation of BU-related accidents at least once a month in past 3 months (Figure). Conclusion Patients with moderate-to-severe CD reported similar experiences of BU in the Europe and US, with most patients reporting currently experiencing BU and wearing diaper/pad/protection due to fear of BU-related accidents at least once a month. Patients currently experiencing BU had short deferral times, often having to reach the bathroom in ≤5 mins. Given the substantial burden and impact, BU should be considered when assessing patients with CD.