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Hansen S.,Copenhagen University | Baptiste K.E.,Danish Health and Medicines Authority | Fjeldborg J.,Copenhagen University | Horohov D.W.,University of Kentucky
Ageing Research Reviews | Year: 2015

The equine aging process involves many changes to the immune system that may be related to genetics, the level of nutrition, the environment and/or an underlying subclinical disease. Geriatric horses defined as horses above the age of 20, exhibit a decline in body condition, muscle tone and general well-being. It is not known whether these changes contribute to decreased immune function or are the result of declining immune function. Geriatric years are characterized by increased susceptibility to infections and a reduced antibody response to vaccination as a result of changes in the immune system. Humans and horses share many of these age-related changes, with only a few differences. Thus, inflamm-aging and immunosenescence are well-described phenomena in both human and equine research, particularly in relation to the peripheral blood and especially the T-cell compartment. However, the lung is faced with unique challenges because of its constant interaction with the external environment and thus may not share similarities to peripheral blood when considering age-related changes in immune function. Indeed, recent studies have shown discrepancies in cytokine mRNA and protein expression between the peripheral blood and bronchoalveolar lavage immune cells. These results provide important evidence that age-related immune changes or 'dys-functions' are organ-specific. © 2014 Elsevier B.V.

Nordahl H.,Copenhagen University | Lange T.,Copenhagen University | Osler M.,Glostrup University Hospital | Diderichsen F.,Copenhagen University | And 5 more authors.
Epidemiology | Year: 2014

Background: Differential exposures to behavioral risk factors have been shown to play an important mediating role on the education-mortality relation. However, little is known about the extent to which educational attainment interacts with health behavior, possibly through differential vulnerability. Methods: In a cohort study of 76,294 participants 30 to 70 years of age, we estimated educational differences in cause-specific mortality from 1980 through 2009 and the mediating role of behavioral risk factors (smoking, alcohol intake, physical activity, and body mass index). With the use of marginal structural models and three-way effect decomposition, we simultaneously regarded the behavioral risk factors as intermediates and clarified the role of their interaction with educational exposure. Results: Rate differences in mortality comparing participants with low to high education were 1,277 (95% confidence interval = 1,062 to 1,492) per 100,000 person-years for men and 746 (598 to 894) per 100,000 person-years for women. Smoking was the strongest mediator for cardiovascular disease, cancer, and respiratory disease mortality when conditioning on sex, age, and cohort. The proportion mediated through smoking was most pronounced in cancer mortality as a combination of the pure indirect effect, owing to differential exposure (men, 42% [25% to 75%]; women, 36% [17% to 74%]) and the mediated interactive effect, owing to differential vulnerability (men, 18% [2% to 35%], women, 26% [8% to 50%]). The mediating effects through body mass index, alcohol intake, or physical activity were partial and varied for the causes of deaths. Conclusion: Differential exposure and vulnerability should be addressed simultaneously, as these mechanisms are not mutually exclusive and may operate at the same time. Copyright © 2014 by Lippincott Williams & Wilkins.

Due U.,Copenhagen University | Brostrom S.,Danish Health and Medicines Authority | Lose G.,Copenhagen University
Acta Obstetricia et Gynecologica Scandinavica | Year: 2013

Objective To translate the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) and to evaluate their psychometric properties in Danish women with symptomatic pelvic organ prolapse. Design and setting Cross-sectional, university hospital setting. Sample Women with symptomatic pelvic organ prolapse (n = 132). Methods A panel of gynecologists performed three independent translations, which were combined and psychometrically evaluated through interviews and pretesting. Main outcome measures Construct, content and convergent validity. Internal consistency and reliability. Sensitivity to change, responsiveness and minimal clinical important difference. Results After two revisions PFDI-20 demonstrated good construct and content validity but PFIQ-7 showed major ceiling effect and lacked items describing affection of health-related quality of life. Convergent validity was moderate with only single items of PFDI-20 correlating with the pelvic organ prolapse quantification system (POP-Q) and only weak to moderate correlations between PFDI-20 and PFIQ-7 scores. Cronbach's alpha and inter-item-total correlation analysis were satisfactory overall. Intra-class correlation coefficient demonstrated good reliability for all but one subscale (r = 0.701-0.894 p < 0.001). Wilcoxon signed rank test showed significant sensitivity to change. Effect size and standardized response mean was good in pelvic organ prolapse subscales and correlated with the Patient Global Index of Improvement scale (PGI-I). Minimal clinical important difference could not be clearly demonstrated. Conclusion The Danish version of PFDI-20 is valid while the PFIQ-7 has a major ceiling effect and lacks items about health-related quality of life. The subscales of PFDI-20 and PFIQ-7 demonstrate good internal consistency and reliability. Pelvic organ prolapse subscales show good responsiveness. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Callreus T.,Danish Health and Medicines Authority
Pharmaceutical Medicine | Year: 2013

Traditionally, bioethics has focused on the obligations of healthcare professionals and the rights of individual patients as well as participants in clinical research. However, in recent years, this center of attention has been questioned and a new "Public Health Ethics" has emerged. It argues that when dealing with ethical issues related to research or interventions, the health of groups and populations should be considered and not only that of individuals. This article reviews the background to the current debate on Public Health Ethics as well as some ethical theories and principles guiding its development. Following a discussion of issues in pharmacovigilance with an ethical dimension, the article explores the potential implications of the emergence of a Public Health Ethics perspective for regulatory pharmacovigilance as a public health activity. In summary it appears that this new perspective may offer a new take on ethical issues in pharmacovigilance and provide guidance as to when public health paternalism is justified or when the public good should take precedence over rights of individuals. © 2013 Springer International Publishing Switzerland. Reference:.

Olofsson P.,Skane University Hospital | Ayres-De-Campos D.,University of Porto | Kessler J.,University of Bergen | Tendal B.,Danish Health and Medicines Authority | And 2 more authors.
Acta Obstetricia et Gynecologica Scandinavica | Year: 2014

We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis. © 2014 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons on behalf of Nordic Federation of Societies of Obstetrics and Gynecology.

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