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    'One mission accomplished, more important ones remain': commentary on Every-Palmer, S., Howick, J. (2014) How evidence-based medicine is failing due to biased trials and selective publication. Journal of Evaluation in Clinical Practice, 20 (6), 908-914
    (Journal of Evaluation in Clinical Practice, 2015-06) Wyer, Peter; Silva, Suzana Alves da
    Every-Palmer and Howick suggest that evidence-based medicine (EBM) is failing in its mission because of contamination of research by manufacturer and researcher-motivated bias and self-interest. They fail to define that mission and to distinguish between the EBM movement and the research enterprise it was developed to critique. An educational movement, EBM accomplished its mission to simplify and package clinical epidemiological concepts in a form accessible to clinical learners. Its wide adoption within educational circles fostered critical literacy among several generations of practitioners. Illumination of bias, subterfuge and incomplete reporting of research has been a strength of EBM. Increased uptake and use of clinical research within the health care system properly defines the failing mission that eludes Every-Palmer and Howick. Responsibility for failure to make progress towards its achievement is shared by virtually all relevant streams within the system, including policy, clinical guideline development, educational movements and the development of approaches to evidence synthesis. Discordance between the epistemological premises pervading today’s research and health care community and the complex social processes that ultimately determine research use constitutes an important factor that must be addressed as part of a remedy. Enhanced emphasis on and demonstration of alternative approaches to research such as realism and realist synthesis and the momentum towards development of a learning health care system hold promise as guideposts for the rapidly evolving health care environment.
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    Relationship-centred care: antidote, guidepost or blind alley? The epistemology of 21st century health care
    (Journal of Evaluation in Clinical Practice, 2014-06) Wyer, Peter; Silva, Suzana Alves da; Post, Stephen G; Quinlan, Patricia
    Contemporary health care is increasing in complexity and lacks a unifying understanding of epistemology, methodology and goals. Lack of conceptual consistency in concepts such as 'patient-centred care' (PCC) typifies system-wide discordance. We contrast the fragmented descriptions of PCC and related tools to its own origins in the writings of Balint and to a subsequent construct, relationship-centred care (RCC). We identify the explicit and elaborated connection between RCC and a defined epistemological foundation as a distinguishing feature of the construct and we demonstrate that this makes possible the recognition of alignments between RCC and independently developed constructs. Among these, we emphasize Schon's reflective practice, Nonaka's theory of organizational knowledge creation and the research methodology of realist synthesis. We highlight the relational principles common to these domains and to their common epistemologies and illustrate unsatisfying consequences of adherence to less adequate epistemological frameworks such as positivism. We offer RCC not as an 'antidote' to the dilemmas identified at the outset but as an example that illuminates the value and importance of explicit identification of the premises and assumptions underlying approaches to improvement of the health care system. We stress the potential value of identifying epistemological affinities across otherwise disparate fields and disciplines. Keywords: evidence-based medicine; patient-centred care; person-centred medicine.
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    Seven years of use of implantable cardioverter-defibrillator therapies: a nationwide population-based assessment of their effectiveness in real clinical settings
    (BMC Cardiovascular Disorders, 2015) Migowski, Arn; Ribeiro, Antonio Luiz; Carvalho, Marilia Sá; Azevedo, Vitor Manuel Pereira; Chaves, Rogério Brant Martins; Hashimoto, Lucas de Aquino; Xavier, Carolina de Aquino; Xavier, Regina Maria de Aquino
    Background: The efficacy of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) therapy has already been established in clinical trials but their effectiveness in several clinical settings remains undetermined. This study aimed to assess the effectiveness of ICD and CRT-D therapies within the Brazilian National Health System (SUS). Methods: All patients who underwent ICD or CRT-D implantation within the SUS from 2001 to 2007 were included in the study. We compared estimated Kaplan-Meier survival curves using the Peto’s test. Prognostic factors were selected using Cox’s models. Results: There were included 3,295 patients in the ICD group and 681 patients in the CRT-D group. Cardiac causes accounted for 79% of all deaths in both groups and Chagas’ heart disease accounted for 31% of these deaths. In the CRT-D group, survival significantly decreased around the fourth year of follow-up, with a decrease from 59.5% to 38.3% in 5.5 months. Transvenous implantation technique was used in 62% of CRT-D patients. In-hospital case-fatality rates were higher in those undergoing surgical implantation (5.3%) than those undergoing transvenous implantation (1.6%) (p = 0.02). Conclusions: The results show that short-term, medium-term and long-term effectiveness of ICD therapy appears to be similar to that evidenced in clinical trials. In the CRT-D group, in-hospital case-fatality and 30-day case-fatality were higher than those reported in other studies. Surgical epicardial implantation technique was performed in this group at a higher frequency than that reported in the literature and was associated with poorer short-term prognosis.