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      The Medical Devices Special Access Program in Canada: A Scoping Study Translated title: Programme canadien d'accès spécial aux instruments médicaux: étude de l'étendue

      research-article
      , BSc, MLT , , Phd, MHSA, , MSc, Phd
      Healthcare Policy
      Longwoods Publishing

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          Abstract

          New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization.

          Translated abstract

          Les nouvelles technologies de la santé font leur entrée dans les organismes de santé de plusieurs façons qu'il est essentiel de comprendre pour le développement d'une stratégie pancanadienne pour la gestion des technologies de la santé (GTS), laquelle est devenue une priorité pour les gouvernements au Canada. Un des chemins d'entrée de ces technologies est le programme d'accès spécial aux instruments médicaux (PASIM) de Santé Canada, qui permet aux professionnels de la santé d'avoir accès à des instruments non homologués. Toutefois, les circonstances et les répercussions de l'usage actuel du programme ne sont pas claires. Ainsi, une revue de la littérature a été menée pour clarifier ces questions et déterminer les rôles et enjeux importants liés au PASIM. Peu d'informations ont été trouvées sur le PASIM. Néanmoins, trois thèmes se sont dégagés pour démontrer les rôles du PASIM dans la GTS : un arbitre pour le choix d'une technologie, une route pour l'obtention d'une technologie et un facilitateur d'innovation dans les technologies de la santé. Aucune information suggérant que le PASIM est employé pour éviter l'homologation n'a été trouvée. Il aide plutôt à atteindre les résultats souhaités pour les patients ainsi que la commercialisation d'un produit.

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          Knowledge transfer for the management of dementia: a cluster-randomised trial of blended learning in general practice

          Background The implementation of new medical knowledge into general practice is a complex process. Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QCs) and QCs alone. Methods In this cluster-randomised trial with QCs as clusters and general practitioners (GPs) as participants, 389 GPs from 26 QCs in the western part of Germany were invited to participate. Data on the GPs' knowledge were obtained at three points in time by means of a questionnaire survey. Primary outcome was the knowledge gain before and after the interventions. A subgroup analysis of the users of the online modules was performed. Results 166 GPs were available for analysis and filled out a knowledge test at least two times. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores. Conclusion A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge. Trial registration Current Controlled Trials ISRCTN36550981.
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            What are scoping studies? A review of the nursing literature.

            Scoping studies are increasingly undertaken as distinct activities. The interpretation, methodology and expectations of scoping are highly variable. This suggests that conceptually, scoping is a poorly defined ambiguous term. The distinction between scoping as an integral preliminary process in the development of a research proposal or a formative, methodologically rigorous activity in its own right has not been extensively examined. The aim of this review is to explore the nature and status of scoping studies within the nursing literature and develop a working definition to ensure consistency in the future use of scoping as a research related activity. This paper follows an interpretative scoping review methodology. An explicit systematic search strategy included literary and web-based key word searches and advice from key researchers. Electronic sources included bibliographic and national research register databases and a general browser. The scoping studies varied widely in terms of intent, procedural and methodological rigor. An atheoretical stance was common although explicit conceptual clarification and development of a topic was limited. Four different levels of inquiry ranging from preliminary descriptive surveys to more substantive conceptual approaches were conceptualised. These levels reflected differing dimensional distinctions in which some activities constitute research whereas in others the scoping activities appear to fall outside the remit of research. Reconnaissance emerges as a common synthesising construct to explain the purpose of scoping. Scoping studies in relation to nursing are embryonic and continue to evolve. Its main strengths lie in its ability to extract the essence of a diverse body of evidence giving it meaning and significance that is both developmental and intellectually creative. As with other approaches to research and evidence synthesis a more standardized approach is required.
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              An administrative data merging solution for dealing with missing data in a clinical registry: adaptation from ICD-9 to ICD-10

              Background We have previously described a method for dealing with missing data in a prospective cardiac registry initiative. The method involves merging registry data to corresponding ICD-9-CM administrative data to fill in missing data 'holes'. Here, we describe the process of translating our data merging solution to ICD-10, and then validating its performance. Methods A multi-step translation process was undertaken to produce an ICD-10 algorithm, and merging was then implemented to produce complete datasets for 1995–2001 based on the ICD-9-CM coding algorithm, and for 2002–2005 based on the ICD-10 algorithm. We used cardiac registry data for patients undergoing cardiac catheterization in fiscal years 1995–2005. The corresponding administrative data records were coded in ICD-9-CM for 1995–2001 and in ICD-10 for 2002–2005. The resulting datasets were then evaluated for their ability to predict death at one year. Results The prevalence of the individual clinical risk factors increased gradually across years. There was, however, no evidence of either an abrupt drop or rise in prevalence of any of the risk factors. The performance of the new data merging model was comparable to that of our previously reported methodology: c-statistic = 0.788 (95% CI 0.775, 0.802) for the ICD-10 model versus c-statistic = 0.784 (95% CI 0.780, 0.790) for the ICD-9-CM model. The two models also exhibited similar goodness-of-fit. Conclusion The ICD-10 implementation of our data merging method performs as well as the previously-validated ICD-9-CM method. Such methodological research is an essential prerequisite for research with administrative data now that most health systems are transitioning to ICD-10.
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                Author and article information

                Contributors
                Journal
                Healthc Policy
                Healthc Policy
                LP-HPL
                Healthcare Policy
                Longwoods Publishing
                1715-6572
                February 2018
                February 2018
                : 13
                : 3
                : 40-57
                Affiliations
                Graduate Student, School of Public Health, University of Alberta, Edmonton, AB
                Professor, Health Technology and Policy Unit, School of Public Health, University of Alberta, Edmonton, AB
                Director, Health Technology and Policy Unit, School of Public Health, University of Alberta, Edmonton, AB
                Author notes
                Correspondence may be directed to: Roland K. Maier, School of Public Health, University of Alberta3021, Research Transition Facility8308-114 Street NWEdmonton, AB T6G 2V2780-802-6892780-248-1546 rkmaier@ 123456ualberta.ca
                Article
                10.12927/hcpol.2018.25398
                5863869
                36d28b19-737a-4675-a7da-a2c63635e109
                Copyright © 2018 Longwoods Publishing

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 License, which permits rights to copy and redistribute the work for non-commercial purposes only, provided the original work is given proper attribution.

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