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 outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is the unique and privileged source of information. Other patient-reported health data may not have a clear source of truth, such as co-morbidities and hospitalizations. In such cases, the data reported by patients may supplement, contradict, or agree with EHR and claims data. For example, the EHR may not contain over-the-counter medications or the complete history of hospitalizations for a particular patient. To better understand these sources of data and how to use them in PCTs, The Office of the Assistant Secretary for Planning and Evaluation provided the NIH Collaboratory Coordinating Center with funding to convene an ADAPTABLE Supplement Roundtable Meeting to discuss best practices for capturing these data and the optimal analytic approaches for using the data in a PCT. A meeting summary provides details of the deliberations, and the ADAPTABLE Supplement Report describes results of a literature review of standards for variables of interest. These deliberations resulted in a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set for ADAPTABLE. Additional reference material can be found on GitHub: patient-reported item set from ADAPTABLE in LOINC version 2.64.
For more on PROs, see the Living Textbook resource chapter, Patient-Reported Outcomes.