Artificial intelligence for imaging-based COVID-19 detection: Systematic review comparing added value of AI versus human readers.

Purpose: A growing number of studies have examined whether Artificial Intelligence (AI) systems can support imaging-based diagnosis of COVID-19-caused pneumonia, including both gains in diagnostic performance and speed. However, what is currently missing is a combined appreciation of studies comparing human readers and AI.

Methods: We followed PRISMA-DTA guidelines for our systematic review, searching EMBASE, PUBMED and Scopus databases.

Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

Background: Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties.

Cost-of-illness studies in heart failure: a systematic review 2004-2016.

Background: Heart failure is a major and growing medical and economic problem worldwide as 1-2% of the healthcare budget are spent for heart failure. The prevalence of heart failure has increased over the past decades and it is expected that there will be further raise due to the higher proportion of elderly in the western societies. In this context cost-of-illness studies can significantly contribute to a better understanding of the drivers and problems which lead to the increasing costs in heart failure.

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

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.

Health Economic Impact of a Pulmonary Artery Pressure Sensor for Heart Failure Telemonitoring: A Dynamic Simulation.

Aims: Recently, a permanently implantable wireless system, designed to monitor and manage pulmonary artery (PA) pressures remotely, demonstrated significant reductions in heart failure (HF) hospitalizations in high-risk symptomatic patients, regardless of ejection fraction. The objectives of this study were to simulate the estimated clinical and economic impact in Germany of generalized use of this PA pressure monitoring system considering reductions of HF hospitalizations and the improvement in Quality of Life.

Materials And Methods: Based on the Prospective Health Technology Assessment approach, we simulated the potential of the widespread application of PA pressure monitoring on the German healthcare system for the period 2009-2021.

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

Introduction: 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.

Areas Covered: 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.

Screening for breast cancer with Breast-CT in a ProHTA simulation.

Aims: The potential of dedicated Breast-CT is evaluated by simulating its impact onto the performance of the German breast cancer screening program. Attendance rates, cancer detection and economic implications are quantified.

Methods: Based on a prospective health technology assessment approach, we simulated screening in different scenarios.

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.

Recalls of cardiac implants in the last decade: what lessons can we learn?

Background: Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities.

Exploring the perspectives and preferences for HTA across German healthcare stakeholders using a multi-criteria assessment of a pulmonary heart sensor as a case study.

Background: Health technology assessment and healthcare decision-making are based on multiple criteria and evidence, and heterogeneous opinions of participating stakeholders. Multi-criteria decision analysis (MCDA) offers a potential framework to systematize this process and take different perspectives into account. The objectives of this study were to explore perspectives and preferences across German stakeholders when appraising healthcare interventions, using multi-criteria assessment of a heart pulmonary sensor as a case study.

A systematic review of health technology assessment tools in sub-Saharan Africa: methodological issues and implications.

Background: Health technology assessment (HTA) is mostly used in the context of high- and middle-income countries. Many "resource-poor" settings, which have the greatest need for critical assessment of health technology, have a limited basis for making evidence-based choices. This can lead to inappropriate use of technologies, a problem that could be addressed by HTA that enables the efficient use of resources, which is especially crucial in such settings.

The main cost drivers in dementia: a systematic review.

Objectives: Because of the increasing prevalence of dementia worldwide, combined with limited healthcare expenditures, a better understanding of the main cost drivers of dementia in different care settings is needed.

Methods: A systematic review of cost-of-illness (COI) studies in dementia was conducted from 2003 to 2012, searching the following databases: PubMed (Medline), Cochrane Library, ScienceDirect (Embase) and National Health Service Economic Evaluations Database. Costs (per patient) by care setting were analyzed for total, direct, indirect and informal costs and related to the following: (1) cost perspective and (2) disease severity.

Assessing new developments in the pre-market regulatory process of medical devices in the People's Republic of China.

The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang.

Registries of implantable medical devices in Europe.

Background: In early 2012, a number of serious events in the implant area raised public awareness and started a discussion on safety issues and monitoring medical devices in academics and politics. Apparently, there is a lack in the surveillance of medical devices. Therefore, the objective of this work is to detect and classify implant registries in Europe.

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.

An international review of the main cost-effectiveness drivers of virtual colonography versus conventional colonoscopy for colorectal cancer screening: is the tide changing due to adherence?

Objectives: The majority of recent cost-effectiveness reviews concluded that computerised tomographic colonography (CTC) is not a cost-effective colorectal cancer (CRC) screening strategy yet. The objective of this review is to examine cost-effectiveness of CTC versus optical colonoscopy (COL) for CRC screening and identify the main drivers influencing cost-effectiveness due to the emergence of new research.

Methods: A systematic review was conducted for cost-effectiveness studies comparing CTC and COL as a screening tool and providing outcomes in life-years saved, published between January 2006 and November 2012.

Cost of illness in colorectal cancer: an international review.

Objectives: Given the current-and increasing-pressure to limit expenditure on health care provision in many countries, a better understanding of the cost burden of colorectal cancer is needed. Cost-of-illness studies and reviews thereof can be a useful tool for analysing and critically evaluating the cost-related development of colorectal cancer, and they highlight important cost drivers.

Methods: A systematic review was conducted from 2002 to 2012 to identify cost-of-illness studies related to colorectal cancer, searching the Medline, PubMed, Science Direct, Cochrane Library and the York CRD databases.