An evidence-base and implementation framework for promoting best practices in pharmaceutical interventions for hearing loss (PIHL) research

Abstract

Pharmaceutical interventions for hearing loss (PIHL) have many biological and physiological targets, highly variable study designs, incomparable outcomes, and no Federal Drug Administration (FDA)-approved drug after more than three decades of research. This project seeks to create the platforms and tools for scientific progress in this field with a novel model of translational research management. This effort includes a systematic review of PIHL studies to understand the key elements of study methods being employed across this field. A stakeholders group was developed to identify research barriers, determine prioritized issues to address, and provide expertise and consensus for the development of evidence-based Best Research Practices (BRPs). Using PIHL literature obtained through standardized systematic review search methods, this effort identified, characterized, evaluated and correlated the methodological variables across the full translational scope of PIHL studies, from animal to human species. Publications from original reports of pre-clinical animal or human studies of interventions to prevent or treat hearing loss or peripheral tinnitus caused by noise or blast exposure were included. A total of 3,492 articles published prior to January 2017 were returned in the librarian-assisted, Boolean search. The final set of included articles were limited to noise- or blast-induced hearing loss targets only and data extraction was completed on 213 articles. The establishment of the PIHL network, comprised of over 200 interdisciplinary experts, provides the platform for discussion, consensus and development of state-of-the-science determinations and BRPs. Outcomes will be translated into recommendations for the consideration of the FDA, funding agencies, and primary peer-reviewed journal editorial boards as part of an overall knowledge dissemination, implementation and adoption strategy. Dissemination pathways, including journal special issues, conference presentations, as well as network discussion, consensus, and adoption are explored as key elements of the overall effort. Early disseminations include 6 PIHL Newsletters, approximately 50 articles published or pending publication in four targeted peer-reviewed journals, and 9 presentations at national conferences. Critical review and understanding of the state of current study methods provide the evidence-base to set norms and standards, which can avoid research waste, thus protecting study subjects and resources and more quickly benefit target patient populations.