Additional file 1: of Cost-of-illness studies in heart failure: a systematic review 2004–2016

List of search terms, databases and results of each search. (DOCX 13 kb

Additional file 2: of Health economic evaluations of non-pharmacological interventions for persons with dementia and their informal caregivers: a systematic review

Quality assessment of included studies according to the 10-item Drummond check-list. (PDF 199 kb

Additional file 1: of Health economic evaluations of non-pharmacological interventions for persons with dementia and their informal caregivers: a systematic review

Search strategies and search results. (PDF 106 kb

Additional file 2: of Cost-of-illness studies in heart failure: a systematic review 2004–2016

Criteria used for inclusion/exclusion of reviewed articles. (DOCX 14 kb

Quality criteria for medical device registries: best practice approaches for improving patient safety – a systematic review of international experiences

<p><b>Introduction:</b> As the benefit of medical device registries (MDRs) depends on their content and quality, it is important to ensure that MDRs have a robust and adequate structure to fulfill their objectives. However, no requirements are specified for the design and content of MDRs. The aim of this work is to analyze different MDRs in the field of implants and to give best practice recommendations for quality criteria regarding their design and development.</p> <p><b>Areas covered:</b> A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified 66 articles describing either a general MDR structure or the development process of specific registries. Extracted information about MDRs served as the basis for recommendations: MDRs should deliver a minimal data set and report information about the geographical area, data collection, numbers of patients enrolled, registry staff, and security and confidentiality of data.</p> <p><b>Expert commentary:</b> Well-structured registries are a cornerstone of the regulatory process of medical devices and a major tool for decision makers. A future goal is to establish agreed minimal data sets for different devices – overcoming national borders. By establishing clear guidelines, the outcomes as well as registry comparability can be fundamentally improved.</p

Accessing the medical devices market in Egypt and Saudi Arabia: a systematic review of policies and regulations

<p><b>Introduction:</b> Despite the significant medical devices market size in Egypt and Saudi Arabia, information regarding policies and regulations for medical devices market access is highly deficient.</p> <p><b>Areas covered:</b> The aim of this paper is to provide a systematic review on market access policies and regulations in both countries, to allow safe and timely access to medical technology. The following databases were searched: PubMed, Science Direct, Scopus, and Al Manhal Arabic database. Additionally, the web portals of regulatory authorities of both countries were searched. There are 34 records included in the qualitative synthesis of this review.</p> <p><b>Expert commentary:</b> Main findings include; adopted regulatory framework from reference countries, and interim main regulatory documents, In conclusion, the market access schemes are relatively structured. However, some recommendations are put forward to navigate towards a more comprehensive policy framework in both countries.</p

Acceptance by laypersons and medical professionals of the personalized eHealth platform, eHealthMonitor

<p><i>Introduction and background</i>: Often, eHealth services are not accepted because of factors such as eHealth literacy or trust. Within this study, eHealthMonitor was evaluated in three European countries (Germany, Greece, and Poland) by medical professionals and laypersons with respect to numerous acceptance factors. <i>Methods</i>: Questionnaires were created on the basis of factors from literature and with the help of scales which have already been validated. A qualitative survey was conducted in Germany, Poland, and Greece. <i>Results</i>: The eHealth literacy of all participants was medium/high. Laypersons mostly agreed that they could easily become skillful with eHealthMonitor and that other people thought that they should use eHealthMonitor. Amongst medical professionals, a large number were afraid that eHealthMonitor could violate their privacy or the privacy of their patients. Overall, the participants thought that eHealthMonitor was a good concept and that they would use it. <i>Discussion and conclusion</i>: The main hindrances to the use of eHealthMonitor were found in trust issues including data privacy. In the future, more research on the linkage of all measured factors is needed, for example, to address the question of whether highly educated people tend to mistrust eHealth information more than people with lower levels of education.</p