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In December of 2024, David Cella, PhD, and team at Northwestern University Feinberg School of Medicine Department of Medical Social Sciences (MSS) received a grant from the Scleroderma Research Foundation titled “COAST-CONQUEST: Cognitive Debriefing of CONQUEST Clinical Trial Endpoint Measures.” MSS faculty Karen Kaiser, PhD, and George Green, PhD, serve as co-investigators. Dinesh Khanna, MD, MS, at University of Michigan serves as an external co-PI, and Monique Hinchcliff, MD, MS, at Yale University serves as an external co-investigator.

What are the aims of the project?  

As part of a recent collaborative project (COAST) between Northwestern University and University of Michigan, Cella and collaborators conducted cognitive debriefing interviews of several patient reported outcome questionnaires to ensure the respondents understood the questions as intended. The participants are people living with diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune disease that causes the skin and internal organs to harden and tighten. Cella’s team developed two measures capable of assessing multiple patient-centered domains for individuals living with SSc, the COAST Scleroderma Symptom Questionnaire (COAST SSQ), and the COAST Scleroderma Function and Mood Questionnaire (COAST SFMQ), both of which need to undergo the same cognitive debriefing to gather evidence on the validity of these measures with the SSc population.

The CONQUEST clinical trial, developed by the study funder, Scleroderma Research Foundation, is a phase 2 platform clinical trial testing two therapies to treat individuals living with SSc-related interstitial lung disease (ILD). Within this clinical trial, the above assessments are being used to measure different aspects of patient experience during the clinical trial. This research project will help ensure that subsequent clinical trials of new treatments for SSc will use valid, responsive, and interpretable patient reports assessments. The Scleroderma Research Foundation, funders of this work, are conducting the CONQUEST clinical trial and have agreed to add the team’s new SSc-specific questionnaires.  

What are your next steps? 

After the conclusion of the project, the team is preparing for a validation study of the newly developed COAST SSc measures. Because the CONQUEST clinical trial of SSc-ILD has already incorporated the COAST SSc measures, we plan to carry out the validation study alongside the CONQUEST clinical trial.

What do you hope will come out of this funded research? 

This study aims to provide data to support the use of the CONQUEST and COAST COA measures in the SSc clinical trial space. Specifically, for the COAST measures, this work will continue to serve as support for our pursuit of Food and Drug Administration (FDA) Drug Development Tool (DDT) Qualification.