080 Implantable Miniature Telescope – Implementing Guidelines When Evidence Is Uncertain. (15th August 2013) - Gupta, A
Abstract : Background: Age-related macular degeneration (AMD) is the third leading cause of blindness in industrialised countries. The heavy burden of the disease, the expected increase in the number of cases, and a lack of effective treatment options highlight the need to examine new therapies. The implantable miniature telescope (IMT) is a potential new treatment for AMD. However, few high-quality studies are currently available to assess its effectiveness. Despite limited evidence, the US Food and Drug Administration (FDA) and Medicare granted regulatory approval, potentially increasing patient demand. Context: In the context of limited available evidence, but potential patient demand driven by lack of alternatives, a large, US-based integrated healthcare system rapidly developed evidence-based guidance and implementation strategies for IMT. Description of Best Practice: A systematic review was conducted to assess IMT effectiveness. A centralised, collaborative panel of experts was convened based upon clinical expertise, interest in providing IMT surgery, and potential operational volume. Evidence-based recommendations informed rapid development of an implementation strategy over six months. The strategy involved 1) centralised patient review and selection; 2) consent forms that describe benefit vs. harms; and 3) surgical training standards. Rapid development and distribution of the implementation strategy ensured that IMT would be provided in a timely and appropriate clinical context. The centralised process facilitated development of a patient database to track outcomes and inform future research. Lessons for Guideline Developers, Adaptors, Implementers, and/or Users: Rapid, collaborative, and evidence-based development of clinical guidance and implementation strategies is an effective model for spreading best practices in an environment of uncertain or low-quality evidence.