Outcomes Measured via Direct Patient Report

Choosing and Specifying End Points and Outcomes

Section 4

Outcomes Measured via Direct Patient Report


Lesley Curtis, PhD

Adrian F. Hernandez, MD, MHS

Kevin P. Weinfurt, PhD



Contributing Editor

Karen Staman, MS

Patients want to know how treatments will improve their day-to-day living and quality of life, and patient-reported outcomes (PROs) are often the best way of assessing these outcomes. However, because PROs are not routinely and consistently used in clinical care, they are not regularly recorded as part of the electronic health record (EHR). In the future, PRO measures are expected to be used more widely because payers have started to demand more evidence of quality care in terms of patient-centered outcomes, which is resulting in greater incorporation of PROs into clinical care. But for now, pragmatic trials that rely on data already collected for billing and clinical purposes may have difficulty using PROs as trial outcomes. This is not an insurmountable hurdle, however, as mechanisms can be developed to collect this type of information.

For more on PROs, see the Living Textbook resource chapter, Patient-Reported Outcomes.




Curtis L, Hernandez A, Weinfurt K. Choosing and Specifying End Points and Outcomes: Outcomes Measured via Direct Patient Report. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://www.rethinkingclinicaltrials.org/design/choosing-specifying-end-points-outcomes/outcomes-measured-via-direct-patient-report/. Updated January 8, 2018. DOI: 10.28929/012.