Development and Content Validation of the Patient’s Qualitative Assessment of Treatment – Real-World (PQAT-RW): An Instrument to Evaluate Benefits and Disadvantages of Treatments in Real-World Settings

Abstract

Aude Roborel de Climens,1 Amy Findley,2 Denise P Bury,3 Keri JS Brady,3 Matthew Reaney,4 Adam Gater2 1Patient-Centered Solutions, IQVIA RDS France, La Défense, Cedex, France; 2Patient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK; 3Patient Informed Development & Health Value Translation, Sanofi, Cambridge, MA, USA; 4Patient-Centered Solutions, IQVIA, Reading, UKCorrespondence: Aude Roborel de Climens, Patient-Centered Solutions, IQVIA RDS, France, La Défense, Cedex, France, Email [email protected]: Quantifying patient-perceived benefits and disadvantages of treatments in a real-world setting is increasingly important in healthcare decision-making. The Patient’s Qualitative Assessment of Treatment (PQAT) assesses patient-perceived benefits and disadvantages of treatment, and associated trade-offs potentially influencing patients’ willingness to continue treatment. It has then been modified to capture patients’ perceived magnitude of benefits and disadvantages of treatment quantitatively, as well as qualitatively (PQATv2). However, the PQAT and the PQATv2 were designed for use and validated in a clinical trial setting. The objective of this study was to adapt and test the content validity of a version of the PQATv2 for use in real-world settings (PQAT-RW).Patients and Methods: The PQATv2 was adapted for use in real-world settings (PQAT-RW), and its content was validated in 16 patients with varied chronic medical conditions and medication regimens via semi-structured qualitative interviews.Results: All participants reported that the PQAT-RW was “easy to understand”. The majority (n = 11/16) reported that the items covered all important aspects of their treatment experience, and that no items needed to be removed or added to the instrument. Analysis of free-text responses identified eight global concepts considered by participants when evaluating the benefits and disadvantages of treatment: treatment effectiveness, side effects and method of administration were most frequently considered (as both benefits and disadvantages), followed by frequency of administration, financial considerations, storage, packaging and drug preparation.Conclusion: The results of this study support the content validity of the PQAT-RW. They also demonstrate that using qualitative responses to contextualize quantitative responses provides unique insight into diverse and individualized patient-perceived benefits and disadvantages, and their relative importance, in real-world settings.Keywords: patient-reported outcome measure, qualitative research, real-world evidence, treatment experience

Keywords

• patient-reported outcome measure
• qualitative research
• real-world evidence
• treatment experience.