Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures.

While the use of electronic methods to collect patient-reported outcome data in clinical trials continues to increase, it remains the case that many patient-reported outcome measures (PROMs) have originally been developed and validated on paper. Careful consideration during the move from paper PROMs to electronic format is required to preserve the integrity of the measure and ensure a "faithful migration." Relevant literature has long called out the importance of following migration best practices during this process; nevertheless, such best practices are distributed across multiple documents. This article consolidates and builds upon existing electronic PROM implementation best practice recommendations to provide a comprehensive, up-to-date, single point of reference. It reflects the current consensus based on the significant advances in technology capabilities and knowledge gleaned from the growing evidence base on electronic migration and implementation, to balance the need for maintaining the integrity of the measure while optimizing respondent usability. It also specifies whether the practice is rooted in evidence or expert consensus, to enable those using these best practices to make informed and considered decisions when conducting migration. • This article consolidates and builds upon existing electronic patient-reported outcome measure (PROM) implementation best practices to provide a comprehensive, up-to-date, single point of reference, which reflect the significant advances in technology capabilities and knowledge gleaned from the growing evidence base on electronic migration and implementation. • For each best practice, the rationale is provided (ie, based on scientific evidence, regulatory guidance, or Electronic Clinical Outcome Assessment Consortium expert consensus), and it is classified depending on whether it risks affecting comparability, regulatory acceptability, or optimal usability, to enable a fully informed, standardized approach to electronic PROM implementation. • In cases where sufficient evidence of measurement comparability exists and these best practices have been followed, as concluded by the ISPOR Task Force Good Practices Report recommendations on evidence needed to support measurement comparability among modes of data collection for PROMs, further testing of measurement comparability between modes of data collection is not necessary. [ABSTRACT FROM AUTHOR]