P231: Novel Asynchronous Qualitative Interview System to Enhance Content Validity Evidence for THRIVE-20-PF in Oncology
Poster Presenter
Carolina Navas
COA Manager
IQVIA Spain
Objectives
To describe the development of THRIVE-20-PF, a new physical functioning PRO for oncology, using a novel asynchronous interview-based method compared with traditional one-on-one qualitative interviews.
Method
CDI asynchronous interviews (n=85) enabled diverse cancer sampling via online voice-recorded responses; 30 traditional interviews (15 initial 1:1 comparisons and 15 validating the new method) confirmed content. NLP generated a 65-item Physical Functioning (PF) bank, refined to 20 items via 35 cognitive debriefing.
Results
Concept elicitation identified impacts across four physical functioning subdomains (mobility, dexterity, axial function, and complex activities), generating a comprehensive 65-item bank. The novel asynchronous (CDI) method enabled substantially higher qualitative throughput, completing 85 interviews in the same period of time required to conduct 15 traditional one-on-one interviews, demonstrating the method’s scalability and efficiency.
CDI also broadened the representativeness of the sample, capturing a wide age range (25–68 years) that reflects current trends of increasingly earlier cancer diagnoses in adults. Demographic and clinical heterogeneity was markedly expanded, with 43% non-white participants and experiences spanning 39 cancer types at varying disease stages, contributing to a richer and more inclusive qualitative evidence base. The asynchronous, voice-recorded format reduced participation barriers and facilitated inclusion of patient groups often underrepresented in qualitative Patient Reported Outcome (PRO) research.
Subsequently, 35 cognitive debriefing interviews confirmed that all 65 items were relevant and well understood by cancer patients. Participants then identified the 20 items most meaningful and most impacted by cancer and treatment, ensuring that the final short form retained full coverage across all four physical functioning subdomains.
Conclusion
The THRIVE 20 PF development program shows that the novel asynchronous qualitative interviewing (CDI) can generate content validity evidence more efficiently than traditional 1 on 1 methods. By enabling 85 interviews within the same development period required for only 15 traditional interviews, CDI delivered substantially higher qualitative throughput while achieving comparable content, supporting its validity as a faster, scalable approach for future instrument-development work. While this study showed high concordance between information gathered using the two qualitative approaches, further evaluation of this novel method is needed for more complex concepts than physical functioning.
This method also expanded clinical and demographic heterogeneity, capturing experiences from 39 cancer types across disease stages and a broad adult age range (25–68 years), with meaningful inclusion of younger adults. This broader sampling, strengthens representativeness in line with regulatory expectations for representative patient input and supports evaluation of physical functioning across the full spectrum, including higher-functioning ranges that are often underrepresented in legacy measures and may be prone to ceiling effects.
The resulting THRIVE-20-PF instrument provide oncology specific physical functioning content with strong qualitative support. Planned next steps include quantitative evaluation (reliability, validity, responsiveness), cross calibration to the SF 36v2 10 item physical functioning scale, and development of natural history profiles and benchmarking to support interpretation and integration of THRIVE 20 PF scores in clinical trials and cancer care studies.
