THE USE OF QUALITATIVE (EXIT) INTERVIEWS IN CLINICAL TRIALS- VALUE, IMPLEMENTATION AND KEY CONSIDERATIONS
Author(s)
Gater A, Marshall C, Grant L, Wells J
Adelphi Values Ltd, Bollington, UK
Presentation Documents
Background: As the healthcare industry becomes more patient-centric, ensuring the patient voice is heard throughout the product life cycle is critical. Patient-reported outcome (PRO) measures provide a standardized means of evaluating and monitoring the efficacy and safety of products and services from a patient perspective. However, conducting qualitative interviews as part of clinical research studies provides unique opportunities for in-depth exploration of patient experiences. Objectives: To discuss the application, value and key considerations for implementing qualitative (exit) interviews in clinical research with reference to illustrative examples from a range of disease areas. Results: When implemented in clinical studies alongside PRO assessments, rich data from interviews can be used to contextualize PRO data and provide supplementary insights as part of a mixed-methods approach to evaluating the benefit of medical interventions. Such interviews can also capture concepts that are not adequately measured by available PRO measures (e.g., satisfaction of a novel treatment) or concepts that are too complex to capture reliably using a PRO (e.g., benefit-risk evaluations). When employed in early clinical studies, interviews may also help to generate evidence to evaluate content validity of PRO measures prior to their implementation in pivotal studies. Qualitative exploration of the significance of changes experienced by patients can be used to complement quantitative data and help to establish valid responder definitions and interpretation of meaningful change. Finally, feedback during these interviews could inform operational aspects of trial design. Key considerations for sponsors include how best to incorporate interviews into clinical trial programs (either within or outside the clinical trial protocol), timing of interviews in the study schedule, standardization of data collection and analysis and how to minimize patient burden. Conclusions: Qualitative (exit) interviews provide a novel and valuable means of maximizing insight from study participants but pose unique considerations for implementation into clinical research.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PRM180
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Multiple Diseases