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eCOA Consortium develops new resource for best practices.
The value proposition for the electronic implementation of patient-reported outcome (PRO) measures (PROMs) is well established, but the migration and implementation of measures initially developed for paper administration requires careful consideration and demands adherence to what has been either defined or recommended as best practice.1
In recent years, the Electronic Clinical Outcome Assessment (eCOA) Consortium members have observed a high number of sponsors implementing electronic PROs (ePROs) in their clinical trials having to locate, digest, and compare a range of different documents and resources pertaining to ePRO implementation best practices. In its previous incarnation as the Electronic Patient-Reported Outcome (ePRO) Consortium, several papers were developed that made substantial contributions to the literature,2,3 and in combination with key papers developed by ISPOR,4,5 they together described the core of best practices in the field.
However, even that consensus-developed work could not be classified as definitive and complete, as other important scientific works developed by organizations such as Oxford University Innovation6 and papers generated by select groups of experts contributed to what could collectively be labeled as “best practice.” What has long been required is a consolidation of these best practices that represents the true consensus.
As is the way with technological progress today, the capabilities of electronic devices utilized for ePRO data capture has advanced substantially, yet documented best practices have not kept pace with these advancements. Therefore, any definitive work must ensure contemporaneousness as far as possible.
To address the critical need for an authoritative, consensus-developed and technologically-relevant resource for ePRO best practices, the eCOA Consortium developed the Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures,7 the pre-print of which was published by Value in Health on Oct. 23, 2023.
This consolidation of best practices articulates the vital need to align with measurement comparability requirements and regulatory guidance, as well as recognition of where usability for the individuals completing these measures can be optimized.
Balancing maintenance of the scientific integrity of a measure with optimized accessibility is critical.Transparency is key in this step-by-step guide detailing the key system and screen design requirements for successfully implementing ePROs as well as best practices. Detail is provided about whether a given practice is rooted in evidence or expert consensus, thus enabling those utilizing the practices to take a fully informed, considered, and standardized approach to implementation. Screenshots depicting the practices are provided throughout, to ensure shared understanding, and a flow diagram guiding those implementing ePRO through the process and the key design decisions.
Ultimately, this work serves as the true consensus on the best practices for ePRO migration and implementation, endorsed by the 23 eCOA technology or allied service providers that form the eCOA Consortium.
However, publication does not signal the end of this effort—socialization of the best practices among all stakeholders is crucial to truly facilitate standardization of ePRO implementation. PRO measure copyright holders and instrument authors are key to ensuring the widespread adoption of these best practices, and to mitigate the risk of any specific implementation guidance being at odds with those outlined by the Consortium, it is important to effectively communicate the updated best practices and their rationale to these key stakeholders. Furthermore, clinical trial sponsors are responsible for ensuring that the data they capture are fit for regulatory submission.
ePRO data are an increasing component of regulatory submissions, so the adoption of the most up-to-date best practices to ensure optimal data integrity is critical.
We believe this single point of reference will serve as a blueprint for the industry for many years to come, and we look forward to this resource being adopted by all those engaged in the field of eCOA. Though we must not become complacent, there is still research to do, and best practices should evolve as the evidence base expands.
Authored on behalf of Critical Path Institute’s eCOA Consortium by Florence Mowlem, PhD, Vice President, Science, ObvioHealth, and Scottie Kern, Executive Director, eCOA Consortium