PRM148 - Innovation In The Development And Validation Of Clinical Outcome Assessments (Coa): An Exploration Of Patient-Cenetered Creative Methodologies

Abstract

There is increasing interest in innovation in the development and validation of clinical outcome assessments (COAs), fuelled by the need to demonstrate robust evidence of content validity for regulatory approval with ever increasing budget and time constraints. Traditionally, qualitative research methods have relied upon standard one-one interview and focus groups techniques; however these may not always be appropriate, particularly for patients with communication difficulties or in pediatric populations or for sensitive research areas. Creative methodologies can be a pragmatic way to elicit patient-driven insights and identify appropriate outcomes in special populations. There is a well-established literature base exploring the use of creative methodologies in social research and many of these approaches can be readily applied to outcomes research. We have reviewed a variety of creative methods and purposively selected the most valuable approaches to create a toolkit of methods to advance the development of patient-centred COAs. The toolkit of creative methods is discussed in context of: 1) disease and clinical characteristics, 2) patient demographics and 3) research objectives. Integration of creative methodologies throughout the COA development process serves to develop patient-driven insights for concept elicitation and item generation. By advancing elicitation techniques (e.g. visual elicitation), and ecological evidence generation (e.g. video diaries) participants’ have the power and freedom to show how they perceive and experience their condition, rather than reliance on verbal report. Creative methodologies can be used to demonstrate reliable, valid and content rich data for a variety of populations and contexts of use. There are exciting opportunities to build upon existing practice and advance creative research approaches in this field. Integrating such methodologies generates patient insight to underpin content development for COAs ensuring they are developed with an evolving fit for purpose approach. The application of such methods for regulatory COA development requires further exploration.