Patients' experiences of completing patient-reported outcomes in clinical trials: An interview study

Abstract

This study aimed to gain insight into how older men diagnosed with prostate cancer experience responding to ePRO about their quality of life in a clinical trial as well as what motivates and demotivates them in the process. Drop-outs in patient-reported outcome studies are a well-known challenge that influence both the reliability and validity of clinical trials. Furthermore, retaining older people in electronic patient-reported outcome (ePRO) studies has proven difficult. This study was based on qualitative semi-structured interviews with 13 male patients. The interviews were conducted between April and May 2022 and were audio-recorded and transcribed verbatim. We analysed the interview inductively using Braun and Clark's thematic analysis. Resulting in five core themes among participants' responses: (1) the ePRO frame is feasible, (2) it is challenging to rate one's life on a scale, (3) increased disease insight, (4) unmet expectations of emotional support, and (5) from motivation to demotivation. The informants were motivated primarily by the idea of helping with new knowledge, but also because ePRO was seen as easy to use and access from home. They were further motivated by the new knowledge they gained through ePRO about symptoms and the possibility to follow their own progress. However, relating to their own quality of life creates an expectation that nurses and doctors will do the same in their treatment, and when this does not happen, the initial motivation turns into demotivation as ePRO knowledge was not used to tailor their treatment and follow-up. In conclusion, older men can participate in ePRO. They are motivated by helping with new knowledge, the ability to answer ePRO from home, and the insights they gain from the questionnaire. They lose motivation when their responses are not used to tailor their disease management.