The Virtual International Stroke Trials Archive

Background and Purpose - Stroke has global importance and it causes an increasing amount of human suffering and economic burden, but its management is far from optimal. The unsuccessful outcome of several research programs highlights the need for reliable data on which to plan future clinical trials. The Virtual International Stroke Trials Archive aims to aid the planning of clinical trials by collating and providing access to a rich resource of patient data to perform exploratory analyses. Methods - Data were contributed by the principal investigators of numerous trials from the past 16 years. These data have been centrally collated and are available for anonymized analysis and hypothesis testing. Results - ”Currently, the Virtual International Stroke Trials Archive contains 21 trials. There are data on 15 000 patients with both ischemic and hemorrhagic stroke. Ages range between 18 and 103 years, with a mean age of 6912 years. Outcome measures include the Barthel Index, Scandinavian Stroke Scale, National Institutes of Health Stroke Scale, Orgogozo Scale, and modified Rankin Scale. Medical history and onset-to-treatment time are readily available, and computed tomography lesion data are available for selected trials. Conclusions - This resource has the potential to influence clinical trial design and implementation through data analyses that inform planning. (Stroke. 2007;38:1905-1910.)

MATCH: a new industry-focused approach to medical device development

MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the product lifecycle in order to achieve devices that truly meet the requirements of their users. A review of the published literature indicates that user requirements are mainly collected during the design and evaluation stage of the product lifecycle whilst other areas, including the concept stage, have less user involvement. Complementing the literature review is an in-depth consultation with the medical device industry, which has identified a number of barriers encountered by companies when attempting to capture user requirements. These will be addressed by a number of case study projects, performed in collaboration with our industrial partners, that will examine the application and utility of different approaches to collecting and analysing data on user requirements. MATCH is focused on providing advice to device developers on how to select and apply methods that have maximum theoretical strength, practical application, cost-effectiveness and likelihood of wide sector acceptance. Feedback will be sought in order to ensure that the needs of the diverse medical device sector are met.

How does the healthcare industry involve users in medical device development? Pointers for UbiHealth

This paper introduces the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) and outlines the problem of integrating a user-centred approach for development of medical devices together with the information and communication technology environments in which they are increasingly required to operate. We highlight some of the regulatory requirements that are relevant to user needs consideration in medical device development. Finally, we reveal a range of limitations in the current practice of the medical device industry in the area of user needs capture, based on responses from interviews with MATCH’s industry partners.