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ELECTRONIC DEVICES FOR COGNITIVE IMPAIRMENT SCREENING: A SYSTEMATIC LITERATURE REVIEW.
Related Articles

ELECTRONIC DEVICES FOR COGNITIVE IMPAIRMENT SCREENING: A SYSTEMATIC LITERATURE REVIEW.

Int J Technol Assess Health Care. 2017 Sep 18;:1-20

Authors: García-Casal JA, Franco-Martín M, Perea-Bartolomé MV, Toribio-Guzmán JM, García-Moja C, Goñi-Imizcoz M, Csipke E

Abstract
OBJECTIVES: The reduction in cognitive decline depends on timely diagnosis. The aim of this systematic review was to analyze the current available information and communication technologies-based instruments for cognitive decline early screening and detection in terms of usability, validity, and reliability.
METHODS: Electronic searches identified 1,785 articles of which thirty-four met the inclusion criteria and were grouped according to their main purpose into test batteries, measures of isolated tasks, behavioral measures, and diagnostic tools.
RESULTS: Thirty one instruments were analyzed. Fifty-two percent were personal computer based, 26 percent tablet, 13 percent laptop, and 1 was mobile phone based. The most common input method was touchscreen (48 percent). The instruments were validated with a total of 4,307 participants: 2,146 were healthy older adults (M = 73.59; SD = 5.12), 1,104 had dementia (M = 74.65; SD = 3.98) and 1,057 mild cognitive impairment (M = 74.84; SD = 4.46). Only 6 percent were administered at home, 19 percent reported outcomes about usability, and 22 percent about understandability. The methodological quality of the studies was good, the weakest methodological area being usability. Most of the instruments obtained acceptable values of specificity and sensitivity.
CONCLUSIONS: It is necessary to create home delivered instruments and to include usability studies in their design. Involvement of people with cognitive decline in all phases of the development process is of great importance to obtain valuable and user-friendly products. It would be advisable for researchers to make an effort to provide cutoff points for their instruments.

PMID: 28920567 [PubMed - as supplied by publisher]




MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.
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MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.

Int J Technol Assess Health Care. 2017 Sep 18;:1-7

Authors: Gagliardi AR, Takata J, Ducey A, Lehoux P, Ross S, Trbovich PL, Easty A, Bell CM, Urbach DR

Abstract
OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.
METHODS: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).
RESULTS: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.
CONCLUSIONS: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

PMID: 28918758 [PubMed - as supplied by publisher]