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- Lopes, Renato D., et al.
(author)
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Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer : The Primary Results of the PRONOUNCE Randomized Trial
- 2021
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In: Circulation. - 1524-4539. ; 144:16, s. 1295-1307
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Journal article (peer-reviewed)abstract
- BACKGROUND: The relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial. METHODS: In this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months. RESULTS: Because of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79]; P=0.53). CONCLUSIONS: PRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.
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| 2. |
- Mark, Daniel B., et al.
(author)
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Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA
- 2022
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In: Circulation. - : Ovid Technologies (Wolters Kluwer Health). - 0009-7322 .- 1524-4539. ; 145:17, s. 1294-1307
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Journal article (peer-reviewed)abstract
- BACKGROUND: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy.METHODS: In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index).RESULTS: Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment.CONCLUSIONS: In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.
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- Tjulin, Åsa, et al.
(author)
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An International Online Work Disability Policy Course : How A University Partnership Became A Facilitator
- 2019
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Conference paper (peer-reviewed)abstract
- So what?Our Masters and PhD students within the field of work disability prevention are part of a global economy where challenges and commonalities between nations need to be addressed. International learning collaborations can facilitate student movement from theory (e.g. about different social security systems) to praxis, through interactive knowledge exchange amongst peers (Loisel et al, 2009).An international on-line course can facilitate participation without the need for travel and additional related expenses is a way to foster student equity in higher education.What is the innovation?Our annual 10-week course, “What is fair? International perspectives on equity on work and health”, was first implemented in January 2019.The course, based on cooperation between Mid-Sweden University, University of Waterloo and Mälardalen University in Sweden and Canada, provides the students with unique learning opportunities to work with international peers on course work and group activities while learning about international systems and policy in relation to health, work and equity.Our partnership (with aims to expand) goes beyond the intention to provide an international learning environment; it also includes knowledge exchange between the universities. That is, the partnership includes co-operative development not only between faculty members, but also among pedagogical developers, international relations office administrators and librarians.The outcome?When we meet at the conference, we will have more to tell you about the specific course and experiences gained from faculty members, administrative members but foremost students who have undertaken the course.
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| 7. |
- Tjulin, Åsa, 1976-, et al.
(author)
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Virtual Internationalization – we did it our way
- 2021
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In: Högre Utbildning. - Oslo : Nordic Open Access Scholarly Publishing. - 2000-7558. ; 11:2, s. 1-13
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Journal article (peer-reviewed)abstract
- Using virtual internationalization as a key concept, this article adds to the body of experience-based knowledge on how to build partnerships and develop courses within higher education. The purpose of this article is to disseminate knowledge about the collaborative process that took place when Swedish and Canadian universities created an international online course focused on work and health. The article presents the challenges and mitigating strategies during course implementation and preconditions that enabled the co-production of the course. The conclusion provides critical reflections, questions and lessons learned that arose from the instructors reflections in relation to virtual internationalization. The self-reflexive experiences were analysed through the lens of internationalization in higher education and virtual internationalization literature, and the theory of social coordination and bureaucracy to enable an understanding of how we did it our way.
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