Balancing costs and benefits at different stages of medical innovation: a systematic review of Multi-criteria decision analysis (MCDA)

Background The diffusion of health technologies from translational research to reimbursement depends on several factors included the results of health economic analysis. Recent research identified several flaws in health economic concepts. Additionally, the heterogeneous viewpoints of participating stakeholders are rarely systematically addressed in current decision-making. Multi-criteria Decision Analysis (MCDA) provides an opportunity to tackle these issues. The objective of this study was to review applications of MCDA methods in decisions addressing the trade-off between costs and benefits. Methods Using basic steps of the PRISMA guidelines, a systematic review of the healthcare literature was performed to identify original research articles from January 1990 to April 2014. Medline, PubMed, Springer Link and specific journals were searched. Using predefined categories, bibliographic records were systematically extracted regarding the type of policy applications, MCDA methodology, criteria used and their definitions. Results 22 studies were included in the analysis. 15 studies (68 %) used direct MCDA approaches and seven studies (32 %) used preference elicitation approaches. Four studies (19 %) focused on technologies in the early innovation process. The majority (18 studies - 81 %) examined reimbursement decisions. Decision criteria used in studies were obtained from the literature research and context-specific studies, expert opinions, and group discussions. The number of criteria ranged between three up to 15. The most frequently used criteria were health outcomes (73 %), disease impact (59 %), and implementation of the intervention (40 %). Economic criteria included cost-effectiveness criteria (14 studies, 64 %), and total costs/budget impact of an intervention (eight studies, 36 %). The process of including economic aspects is very different among studies. Some studies directly compare costs with other criteria while some include economic consideration in a second step. Conclusions In early innovation processes, MCDA can provide information about stakeholder preferences as well as evidence needs in further development. However, only a minority of these studies include economic features due to the limited evidence. The most important economic criterion cost-effectiveness should not be included from a technical perspective as it is already a composite of costs and benefit. There is a significant lack of consensus in methodology employed by the various studies which highlights the need for guidance on application of MCDA at specific phases of an innovation

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

Clinical Assessment of Amyloid Imaging in Alzheimer’s Disease: A Systematic Review of the Literature

Background/Aims: Healthcare systems face an increased prevalence of Alzheimer's disease and increasing costs. The use of molecular biomarkers and imaging could offer an effective solution for these issues. The objective of this study was to assess amyloid imaging regarding clinical utility and impact. Methods: A literature search was performed in several databases, searching articles between 2008 and January 2013 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results are reported according to the clinical correlates of amyloid imaging. Results: Thirty-three studies were included in the final analysis. Five studies evaluated amyloid imaging for diagnosis. Nine studies assessed the prognostic value. Twenty-two studies provided correlations to cognitive measures. Amyloid imaging provides a high reliability in diagnosis and prognosis, but cognitive measures only showed weak correlations. Conclusion: The evidence clearly indicated that amyloid imaging has not arrived yet in clinical practice. However, it can provide substantial benefits in special aspects of diagnostic accuracy and for a diagnosis up to 10 years before clinical diagnosis. This can be a base for early preventive treatment strategies such as anti-amyloid therapy. In this context, amyloid imaging is crucial to understand the early pathologic process in Alzheimer's disease