| 1. |
|
|
| 2. |
- Cowie, M. R., et al.
(författare)
-
New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment
- 2017
-
Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842. ; 19:6, s. 718-727
-
Tidskriftsartikel (refereegranskat)abstract
- Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.
|
|
| 3. |
|
|
| 4. |
|
|
| 5. |
- Mondani, Hernan, et al.
(författare)
-
What is a social pattern? Rethinking a central social science term
- 2022
-
Ingår i: Theory and society. - : Springer Science and Business Media LLC. - 0304-2421 .- 1573-7853. ; 51:4, s. 543-564
-
Tidskriftsartikel (refereegranskat)abstract
- The main aim of this article is to start a discussion of social pattern, a term that is commonly used in sociology but not specified or defined. The key question can be phrased as follows: Is it possible to transform the notion of social pattern from its current status in sociology as a proto-concept into a fully worked out concept? And if so, how can this be done? To provide material for the discussion we begin by introducing a few different types of patterns that are currently being used (patterns in nature, cultural patterns, statistical patterns, and computationally generated patterns). This is followed by a suggestion for what a strictly sociological concept of social pattern may look like. A useful and theoretically solid concept of social pattern can in our view be constructed by basing it on Weber’s concept of social action. This means that both the behavior of the actors and the meaning these invest their behavior with must be taken into account. The article ends with a brief discussion of how to use the concept of social patterns in an effective way and what may endanger such a use.
|
|
| 6. |
- Nee, Victor, et al.
(författare)
-
On Politicized Capitalism
- 2007
-
Ingår i: On Capitalism. ; , s. 93-127
-
Bokkapitel (övrigt vetenskapligt/konstnärligt)
|
|
| 7. |
- Nyberg, Anita, et al.
(författare)
-
Women in the economy
- 2010
-
Ingår i: Beijing +15. - Stockholm : Integrations- och jämställdhetsdepartementet, Regeringskansliet.
-
Bokkapitel (populärvet., debatt m.m.)
|
|
| 8. |
-
On Capitalism
- 2007
-
Samlingsverk (redaktörskap) (övrigt vetenskapligt/konstnärligt)
|
|
| 9. |
- Paulsen, Roland, et al.
(författare)
-
The counterfactual imagination
- 2014
-
Ingår i: Theorizing in social science. - 9780804791090 - 9780804791199
-
Bokkapitel (refereegranskat)
|
|
| 10. |
- Sturm, Heidrun B, et al.
(författare)
-
Heart failure guidelines and prescribing in primary care across Europe
- 2005
-
Ingår i: BMC health services research. - : Springer Science and Business Media LLC. - 1472-6963. ; 5
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Major international differences in heart failure treatment have been repeatedly described, but the reasons for these differences remain unclear. National guideline recommendations might be a relevant factor. This study, therefore, explored variation of heart failure guideline recommendations in Europe. METHODS: Treatment recommendations of 14 national guidelines published after 1994 were analyzed in relation to the heart failure treatment guideline of the European Society of Cardiology. To test potential relations between recommendations and prescribing, national prescribing patterns as obtained by a European study in primary care (IMPROVEMENT-HF) were related to selected recommendations in those countries. RESULTS: Besides the 14 national guidelines used by primary care physicians in the countries contacted, the European guideline was used in four countries, and separate guidelines for specialists and primary care were available in another four countries. Two countries indicated that no guideline was used up to 2000. Comprehensiveness of the guidelines varied with respect to length, literature included and evidence ratings. Relevant differences in treatment recommendations were seen only in drug classes where evidence had changed recently (beta-blockers and spironolactone). The relation between recommendation and prescribing for selected recommendations was inconsistent among countries. CONCLUSION: Differences in guideline recommendations are not sufficient to explain variation of prescribing among countries, thus other factors must be considered.
|
|
