Improving Adherence to electronic Patient-Reported Outcomes:Study Protocol for a Systematic Literature Review and subsequent qualitative Interviews

Abstract Background Electronic patient-reported outcomes (ePROs) are frequently used to include the patients’ perspective in clinical trials and routine clinical care. In contrast to data collected in clinical trials, PRO response rates tend to decrease drastically overtime in routine clinical care, leading to missing data and questionable validity of results reported. This study aims to investigate factors influencing patient adherence to digitally collected PROs. Method The study comprises of three steps: (1) a systematic literature review (SLR) focusing on factors increasing PRO response rates, (2) focus group interviews with patients to develop criteria on how to increase response rates for real-world evidence (RWE), and subsequently, (3) an anonymous online survey to evaluate developed criteria. The SLR will follow the PRISMA guidelines. The inclusion criteria for the review encompass studies focusing exclusively on patients or people recruited via medical personnel. The literature review will include studies from various settings, encompassing publications in German or English language published within the past 10 years (2014-2024). Participants for the focus group interviews (n = 6-8/group) will be recruited via patient advisory boards or groups/organisations. The findings of the SLR and the focus group form the basis for the anonymous online survey to include more patients. Outlook The results of the study can be incorporated into the development and implementation of digital collection methods for PROs, with the aim of improving adherence to PROs and thus robustness of RWE data.