Development of a de novo Clinical Outcomes Assessment (COA) for Chronic Intestinal Pseudo Obstruction (CIPO)
The overall objective of this study is to develop a de novo CIPO-specific PRO that is 1)able to capture change in core CIPO visible signs and symptoms across all etiologies and severity levels, and 2) is fit for-purpose for use as a primary endpoint in a clinical trial setting. Specifically, this will include: • Development of a de novo CIPO-specific PRO on an electronic platform (ePRO); • Development of a conceptual framework of the de novo PRO;- A conceptual framework is a content map used to demonstrate the expected relationships between items within a domain, and of domains within a PRO tool (Wild et al., 2008). • Conduct of hybrid Concept Elicitation (CE)/Cognitive Interviews and Usability Testing (CIUT), in order to: o 1) Identify concepts of importance to patients and update the draft conceptual model, and- A conceptual model is a diagram of proposed causal linkages among a set of concepts (e.g. visible signs, symptoms, general disease impacts) believed to be related to a particular health problem or disease (Wild et al, 2008). 2) Gain patient input on the relevance, clarity, comprehensiveness and ease of use of the de novo ePRO
This study is actively enrolling patients. To learn more about CIPO and how you can join contact our research office at (314) 289-7690
This study is funded by the Foundation through Alfasigma/ICON
This study is funded by the Foundation through Alfasigma/ICON