Quality of economic evaluations of ventricular assist devices: A systematic review.

Objective: Because of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies.

Evaluation of 3D printing costs in surgery: a systematic review.

Objectives: The use of three-dimensional (3D) printing in surgery is expanding and there is a focus on comprehensively evaluating the clinical impact of this technology. However, although additional costs are one of the main limitations to its use, little is known about its economic impact. The purpose of this systematic review is to identify the costs associated with its use and highlight the first quantitative data available.

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review.

Background: Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.

Materials And Methods: A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database.

Benefits of 3D printing applications in jaw reconstruction: A systematic review and meta-analysis.

Background: Three-dimensional (3D) printing has changed surgical practice over the past few years, especially in maxillofacial surgery. However, little is known about its real clinical impact. The objectives of our study were to identify clinical outcomes that have been evaluated in the literature regarding 3D printing applications in jaw reconstruction, and to quantify the impact of this technology on operating times.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

Objectives: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items.

Study Design And Setting: A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE.

HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?

Background: The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis.

Advantages and disadvantages of 3-dimensional printing in surgery: A systematic review.

Background: Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and disadvantages of 3D printing applied in surgery.

Methods: We conducted a systematic review of articles on 3D printing applications in surgery published between 2005 and 2015 and identified using a PubMed and EMBASE search.

New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues.

We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities.

Combining multi-criteria decision analysis and mini-health technology assessment: A funding decision-support tool for medical devices in a university hospital setting.

Background: At the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a notable example is the Matrix4value model.

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

Context: Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.

Objective: To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.

INTRODUCTION OF INNOVATIVE MEDICAL DEVICES AT FRENCH UNIVERSITY HOSPITALS: AN OVERVIEW OF HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT INITIATIVES.

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.

Special funding schemes for innovative medical devices in French hospitals: the pros and cons of two different approaches.

Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices.

Who cares for former child soldiers? Mental health systems of care in sierra leone.

While numerous studies on former child soldiers (FCS) have shown mental health needs, adequate services are a challenge. This study aimed to identify priorities, barriers and facilitators of mental health care for Sierra Leonean FCS. Thematic analysis was done on 24 qualitative interviews with participants from diverse sectors.