Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high\u2010quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital\u2010based HTA.<\/p>\n\n\n\n
We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5\u2010point level\u2010of\u2010evidence scale.<\/p>\n\n\n\n
We screened and classified 217 studies: 215 clinical trials and 2 cost\u2010effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high\u2010level clinical evidence (levels 1\u20132); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high\u2010quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow\u2010up period and the mean follow\u2010up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device.<\/p>\n\n\n\n
Our findings confirm that only a few studies of innovative medical devices provide high\u2010level clinical evidence. Nevertheless, RCT may be the \u2018gold standard\u2019 for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations.<\/p>\n","protected":false},"featured_media":0,"template":"","categories":[21],"tags":[],"class_list":["post-225258","hta_library","type-hta_library","status-publish","hentry","category-review-papers"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library\/225258","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library"}],"about":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/types\/hta_library"}],"wp:attachment":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/media?parent=225258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/categories?post=225258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/tags?post=225258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}