Data Mining of Free-Text Responses: An Innovative Approach to Analyzing Patient Perspectives on Treatment for Chronic Rhinosinusitis with Nasal Polyps in a Phase IIa Proof-of-Concept Study for Dupilumab

Abstract

Asif H Khan,1 Adeline Abbe,1 Bruno Falissard,2 Paulo Carita,1 Claus Bachert,3,4 Joaquim Mullol,5 Matthew Reaney,6 Jingdong Chao,7 Leda P Mannent,1 Nikhil Amin,7 Puneet Mahajan,8 Gianluca Pirozzi,8 Laurent Eckert1 1Sanofi, Chilly-Mazarin, France; 2Centre de recherche en epidémiologie et santé des populations (CESP), INSERM U1018, Paris, France; 3Upper Airways Research Laboratory, Ghent University, Ghent, Belgium; 4CLINTEC, Karolinska Institutet, Stockholm, Sweden; 5Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, Universitat de Barcelona; Clinical and Experimental Respiratory Immunoallergy, IDIBAPS; and CIBERES, Barcelona, Catalonia, Spain; 6IQVIA, Reading, UK; 7Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 8Sanofi, Bridgewater, NJ, USACorrespondence: Asif H KhanSanofi, 1 Avenue Pierre Brossolette, Chilly-Mazarin, 91380, FranceTel [phone]Email [email protected]: Patient perspective is an important and increasingly sought-after complement to clinical assessment. The aim of this study was to transcribe individual patients’ experience of treatment in a dupilumab clinical trial through free-text responses with analysis using natural language processing (NLP) to obtain the unique perspective of patients on disease impact and unmet needs with existing treatment to inform future trial design.Patients and Methods: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who were enrolled in a Phase IIa randomized controlled trial comparing dupilumab with placebo (NCT01920893) were invited to complete a self-assessment of treatment (SAT) tool at the end of treatment, asking, “What is your opinion on the treatment you had during the trial? What did you like or dislike about the treatment?” Free-text responses were analyzed for the overall cohort and according to treatment assignment using natural language processing including sentiment scoring. In a mixed-methods approach, quantitative patient-reported outcome (PRO) results were utilized to complement the qualitative analysis of free-text responses.Results: Of 60 patients enrolled in the study, 43 (71.6%) completed the SAT and responses from 37 patients were analyzed (placebo, n = 16; dupilumab, n = 21). Word analyses showed that the most common words were “smell,” “improve,” “staff,” “great,” “time,” and “good.” Across the whole cohort, “smell” was the most common symptom-related word. The words “smell” and “experience” were more likely to occur in patients treated with dupilumab. Patients treated with dupilumab also had more positive sentiment in their SAT responses than those who received placebo. The results from this qualitative analysis were reflected in quantitative PRO results.Conclusion: “Smell” was important to patients with CRSwNP, highlighting its importance as a patient-centric efficacy outcome measure in the context of clinical trials in CRSwNP.Trial Registration: ClinicalTrials.gov, NCT01920893. Registered 12 August 2013, https://www.clinicaltrials.gov/ct2/show/NCT01920893.Keywords: CRSwNP, free-text data mining, patient perspective, self-assessment, sense of smell

Keywords

• crswnp
• free-text data mining
• patient perspective
• self-assessment
• sense of smell