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080 Implantable Miniature Telescope – Implementing Guidelines When Evidence Is Uncertain
  1. A Gupta,
  2. P Garg,
  3. D Patel
  1. Kaiser Permanente, Pasadena, USA

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.

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