Abstract

ISPOR has recently updated its recommendations on the evidence needed to support measurement comparability among modes of data collection for patient-reported outcome measures (PROMs).¹ This new ISPOR Good Practices report is an update to the recommendations from the ISPOR 2009 Electronic Patient-Reported Outcomes (ePROs)² and 2014 PRO Mixed Modes Good Research Practices Task Force³ reports. The final report, which was the product of substantial effort by task force members, incorporates feedback from 2 rounds of written review by ISPOR’s Clinical Outcomes Assessment (COA) Special Interest Group. Finalization of these recommendations is an important accomplishment given the enormous amount of new research in this field, the challenges of collaborating across 2 separate task forces, and the coordination needed to achieve consensus among the diverse stakeholders represented, including the US Food and Drug Administration, academia, research organizations, electronic COA service providers, and the pharmaceutical industry.

The COA field has evolved since the 2009 and 2014 reports were published, especially as researchers navigate collecting COA data during a pandemic. Those earlier reports created the foundation of a “faithful migration” of instruments from 1 mode to another, typically from paper-based administration to electronic data collection. The stated goal of a faithful migration was ensuring that subjects interpret and respond to the questions/items on the PRO instrument the same way, regardless of the mode of data collection. Furthermore, earlier reports’ recommendations discouraged mixing modes within a single study, if possible, especially if there was not documented and sufficient evidence to support pooling scores from the different modes. Multiple research designs for gathering necessary evidence were described for both qualitative and quantitative studies. Finally, readers were warned of the risk of increased measurement error caused by the pooled scores, which may lead to a loss of power to detect treatment benefit, and they were cautioned against ignoring their recommendations that discouraged mixing modes.

Between the 2014 and 2023 reports, the COA field experienced many changes. The 2023 report provides an excellent summary of the immense quantity of published research in this area, with detailed references that can facilitate deeper investigation. Building upon these resources and the insights from the task force members, the 2023 report authors describe 2 important goals for the update:

1. To empower readers to make a meaningful assessment of their specific situation, which will vary by PROM, technology, and patient population; and
2. To make the good practices generalizable enough to apply to future scenarios and technologies.

The report goes a long way toward meeting these goals, but ISPOR could produce a valuable and practical companion to the report, by providing case studies of the complete process. These case studies could serve as a detailed roadmap for considering measurement comparability and evaluating supportive evidence.