Electronic formats of clinical outcome assessments (eCOAs) have become the norm. COAs describe or reflect how a person feels, functions, or survives and can be reported by a healthcare provider, a patient, a non-clinical observer, or through performance of an activity or task. While many COAs – of which patient-reported outcome measures (PROMs) are a subset – were originally developed for paper-and-pencil administration, newly developed instruments often include or are solely implemented in an electronic format. This evolution has been paralleled by a growth in the number of digital studies, an increase in uptake of eCOAs in clinical studies, and encouragement of electronic data collection from bodies such as the US Food and Drug Administration¹.
What are the benefits of electronic formats of COAs²?
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- Less administrative burden
- Higher patient acceptance
- Greater flexibility in study design
- Avoidance of secondary data entry errors
- Easier implementation of logic/skip patterns
- More accurate and complete data
- Speed of completion
What do we need to keep in mind for paper-to-electronic migration of PROMs?
The main consideration when migrating paper versions of PROMs to electronic versions is the level of comparability of scores obtained via the original and adapted administration mode – in other words, are the measurement properties of the instrument changed when you migrate the PRO to an electronic version?
One of the bodies providing recommendations to industry and regulators to facilitate electronic data capture while ensuring that data integrity is maintained is the ISPOR Task Force on measurement comparability between modes of data collection for PROMs³. Task Force reports have shaped the research community’s thinking about implementing PROMs electronically in research studies, and their recommendations in the 20094 and 20145 reports have been routinely adopted throughout the industry. This month (May 2023), the Task Force released their most recent recommendation update³.
How have the ISPOR Task Force recommendations evolved?
In their 2009 recommendations, the Task Force indicated evidence such as cognitive interviews and usability testing (for minor modifications due to migration) and quantitative equivalence studies (for moderate modifications due to migration) to be effective in supporting measurement comparability when migrating from paper to electronic formats.
Over the years, however, accumulating evidence has indicated that instrument properties are generally well-conserved in the migration process when best practices for ePROM design are followed. Thus, the most recent update to the Task Force’s recommendations presents several revisions.
1. To determine whether new research is needed to evaluate measurement comparability for a given PROM, the suitability of existing evidence needs to be established.
2. The suitability of existing evidence depends on whether:
a) It has been carried out according to best practices for eCOA design.
b)It satisfactorily demonstrates that migration has not affected the PROM’s measurement properties.
3. If sufficient evidence exists, further testing of measurement comparability between the data collection modes is not necessary.
4. The previous distinction between “minor” and “moderate” levels of modification is no longer considered helpful, as the “moderate” distinction has been demonstrated to not affect comparability. Therefore, changes will be classified as “minor to moderate” or “substantial”.
In terms of best practices for PROM migration, the report additionally notes that, at the time of publication, an initiative is underway within the Electronic Clinical Outcomes Assessment Consortium6 to synthesize and update ePROM best practices into a single publication.
Figure 1: Decision flowchart regarding the need to establish measurement comparability for regulatory submissions. From O’Donohoe et al.
Take-home messages
The implementation of eCOAs has transformed the way patient data is collected and evaluated in healthcare and clinical research. As the use of eCOAs increases, so does the thinking around best practices for paper-to-electronic migration and the requirements for evidencing measurement comparability. Knowledge of these processes is vital to maximize insights into valuable patient data.
At Vitaccess, we have in-house experts in eCOA migration who help our clients streamline the process of PROM implementation in real-world patient-reported study design. For more information on how we could help you, get in touch at info@vitaccess.com.
By Fatemeh Amini and Catherine Bottomley
References
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations
- https://www.sciencedirect.com/science/article/pii/S1098301522001231
- https://www.valueinhealthjournal.com/article/S1098-3015(23)00003-7/fulltext
- https://pubmed.ncbi.nlm.nih.gov/19900250/
- https://pubmed.ncbi.nlm.nih.gov/25128043/
- https://c-path.org/programs/ecoac/
