Introduction and adoption of innovative invasive procedures and devices in the NHS: an in-depth analysis of written policies and qualitative interviews (the INTRODUCE study protocol)

摘要

IntroductionInnovation is key to improving outcomes in healthcare. Innovative pharmaceutical products undergo rigorous phased research evaluation before they are introduced into practice. The introduction of innovative invasive procedures and devices is much less rigorous and phased research, including randomised controlled trials, is not always undertaken. While the innovator (usually a surgeon) may introduce a new or modified procedure/device within the context of formal research, they may also be introduced by applying for local National Health Service (NHS) organisation approval alone. Written policies for the introduction of new procedures and/or devices often form part of this local clinical governance infrastructure; however, little is known about their content or use in practice. This study aims to systematically investigate how new invasive procedures and devices are introduced in NHS England and Wales.