Patient-Reported Outcomes in Multiple Sclerosis: An Overview

Longitudinal PRO data are usually displayed in simple line graphs.^145,146 Overall, line graphs have been found to have the highest ease of understanding by both patients and clinicians, but sometimes can be confusing.¹⁴⁷ For example, upward trending lines are usually viewed as improvement and downward trending lines as decline; however, upward trending scores on a PROM can indicate decline, such as increasing fatigue severity. Annotation of visual displays can help. Patients and clinicians find that employing thresholds and color coding is useful, and better than “stoplight” red-yellow-green shading schemes or red-circle formats to indicate data that warrant attention.¹⁴²

Error Risks

PROs are not free of risk for error, especially if they are used independently of other information sources, such as clinical interview, examination, and diagnostic testing, or if they are utilized too frequently, too infrequently, or are duplicated in practice. If a PRO instrument is employed too frequently, score changes may reflect learning effects rather than actual clinical status. Conversely, if used too infrequently, PRO information will not be timely enough to inform real-time clinical practice. Duplication of PRO assessments (eg, multiple measures of the same PRO for the same patient on the same day) or use of multiple PRO measures to assess the same aspect (eg, 2 measures used to assess fatigue) could introduce unnecessary complexity and confusion to interpretation of PRO results.

PRO measures also can be biased or modified by clinical status and/or perceptions of people with MS at the time of assessment. For example, cognitive impairment, whether at baseline state or due to a cognitive MS relapse event, could impact patients’ ability to understand and respond to PRO assessments, producing erroneous results. However, when used appropriately, PROs targeting cognitive dysfunction may be able to detect onset of cognitive events or help to measure recovery from them. Finally, PROs measure perceived (self-reported) status, which may not be an accurate depiction of actual status.

All of these potential pitfalls support the argument that PROs should be utilized to augment the clinical interview, examination, and diagnostic (objective) testing aspects of comprehensive MS care. In this way, PROs can be correlated with other information sources to deepen the shared understanding of health status between a person with MS and her clinician, increasing the potential to make better treatment decisions and care plans together in partnership.

Value and Cost

National groups such as the Patient-Centered Outcomes Research Institute (PCORI) are working with regulatory bodies, funding agencies, insurance providers, patient advocacy groups, researchers, providers, and specialty groups to investigate how PROMs can be implemented into value-based health care reforms, including value-based reimbursement.¹⁴⁸ However, practical PRO implementation requires considerable time and resources, and many methodological and operational questions must be addressed before widespread adoption and reimbursement for PROMs will be feasible.^148,149