Objective: To update and formalize the International Parkinson and Movement Disorder Society (MDS) Clinical Outcomes Assessment Program guidelines on validating and evaluating electronic clinical outcome assessments (eCOAs).
Background: The transition from paper-based COAs to eCOAs has gained significant interest, particularly for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs). However, there is a lack of consensus on the required evidence to establish equivalence between eCOAs and validated paper-based COAs. Furthermore, standardized guidelines for evaluating electronic observer-reported outcomes (ObsROs) or performance-reported outcomes (PerfOs) are even more limited.
Method: The MDS Electronic COA Committee and the COA Scientific Evaluation Committee are collaborating to develop updated best practices for electronic migration and validation of eCOAs. This initiative includes: 1. Review existing MDS guidelines on eCOA validation; 2. Conduct a gap analysis to identify missing or incomplete guidance; 3. Develop updated recommendations for evaluating PROs, ClinROs, ObsROs, and PerfOs; 4. Publish position papers outlining best practices for eCOA development and validation.
Results: This project was officially launched in January 2025 with an inaugural meeting of MDS COA Scientific Evaluation and eCOA committee members. As part of the initial phase, a review of existing MDS guidelines and international regulatory standards for eCOA validation has been initiated. The committees will then draft updated guidelines, incorporating stakeholder input from regulatory agencies, industry leaders, and clinical researchers. Future steps include expert consensus meetings, data-driven recommendations for validation criteria, and the publication of official MDS guidance documents to standardize the evaluation of electronic assessments across different outcome domains.
Conclusion: The revised guidelines will provide a structured framework for evaluating eCOAs, ensuring methodological rigor in their validation. These recommendations will guide both MDS internal reviews and the broader scientific community in adopting and assessing electronic assessments.
To cite this abstract in AMA style:
R. Fuller, M. Skorvanek, M. Monje, M. Tosin, S. Ali, A. Lofald, A. Sanchez Ferro, T. Mestre. Advancing MDS Guidelines for Electronic Clinical Outcome Assessments: Best Practices for Validation and Implementation [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/advancing-mds-guidelines-for-electronic-clinical-outcome-assessments-best-practices-for-validation-and-implementation/. Accessed November 20, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/advancing-mds-guidelines-for-electronic-clinical-outcome-assessments-best-practices-for-validation-and-implementation/