Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

Abstract

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

The advantages, disadvantages, threats, and opportunities of electronic patient-reported outcome systems in cancer: A systematic review

“…According to our findings, we found several significant advantages of ePRO systems in cancer care: “Improved Quality of Life and Care,” “Real-time and Remote Monitoring,” and “Effective Communication Between Clinicians and Patients.” The most prominent advantage identified was the “Improved Quality of Life and Care”. 14 – 16 , 18 , 31 – 71 This finding is consistent with the study by Gressel et al, which emphasized the prevalence of web-based ePRO systems for long-term monitoring and patient empowerment. 101 Similarly, Moradian et al’s exploration of an eHealth tool for capturing and analyzing immune-related adverse events in cancer treatment 31 and Helissey et al’s assessment of the effectiveness of electronic patient reporting outcomes in prostate cancer care further contributed to understanding the benefits of ePRO systems in cancer care.…”

“…According to Table 1 , The advantages of ePRO were found to be diverse, with “Improved Quality of Life and Care” being the most prominent, cited in 45 studies (28.48%). 14 – 16 , 18 , 31 – 71 This was followed by “Real-time and Remote Monitoring” with 39 references (24.68%), highlighting its significance in real-time health monitoring, which can significantly impact patient outcomes 1 , 16 – 18 , 31 , 33 , 34 , 36 – 39 , 43 , 44 , 47 , 49 …”

Measurement equivalence of the paper-based and electronic version of the Integrated Palliative care Outcome Scale (IPOS): A randomised crossover trial

“…To help older adults and/or those with peripheral neuropathy, qualitative evidence has also supported stylus or pen entry of data into electronic devices instead of the more common swipe-and-touch techniques. 48 …”

“…To help older adults and/or those with peripheral neuropathy, qualitative evidence has also supported stylus or pen entry of data into electronic devices instead of the more common swipe-andtouch techniques. 48 With the demonstration of high reproducibility and concordance between the two versions, the regular use of electronic IPOS in palliative home care may help harness the power of rapid, real-time assessment and feedback to patients and clinicians. This might also enhance interdisciplinary communication and care.…”

Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims

“…Studies have shown that many individuals may prefer to use their own device to respond to PRO instruments [ 10 – 12 ], and so the option of BYOD to capture PRO data can help address patient-centricity by improving the ease of participation. As participants are familiar with their own devices, BYOD could increase engagement and compliance, potentially improving retention and reducing missing data [ 8 ].…”