Introduction

This Guide focuses specifically on the use of PROs in clinical practice for individual patient management (i.e., my clinician using my data to inform my own care). While individual-level patient data collected to inform that patient’s own care can be aggregated for use as real-world evidence, in quality assessment efforts, and in other ways, this Guide focuses primarily on the use of PROs in individual patient-clinician interactions.

As described by the U.S. Food & Drug Administration and others, PROs are patients’ own reports of how they feel, function, live their lives, and survive. A growing evidence base suggests using individual patients’ PRO data to inform their care facilitates patient-clinician communication, helps identify symptoms, informs patient monitoring and management, can improve efficiency, and sometimes, increases survival.

Using PROs in Clinical Care

Using PROs in clinical care effectively requires addressing a range of considerations. Several established resources provide guidance on specific aspects of using PROs in clinical care, such as how to display PRO results or how to integrate PRO data into the electronic health record. This Guide collates and synthesizes the guidance from these foundational resources to create a unified, comprehensive document that covers all stages of the process. For the most comprehensive and detailed information on a topic, we encourage you to review the relevant foundational resources listed at the end of each section. We also suggest you cite these resources directly, in addition to the Guide, as noted in Acknowledgements.

Throughout the Guide, we refer to both patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). We refer to PROs when discussing the outcome itself, or more generally to refer to the field of collecting patient-reported outcomes. We refer to PROMs when we are describing the standardized, validated questionnaire or survey used to elicit information from the patient about a given outcome. Both concepts are distinct from patient-reported experience measures (PREMs), which are questionnaires used to assess patients’ perceptions of their care, although many of the considerations that apply to PROs and PROMs also apply to PREMs.

How the Guide is Organized

The Guide is organized into 16 sections which span three overarching stages of using PROs in practice: Design, Implementation, and System & Data Management. Within each section we present a high-level overview, and then expand upon this information. For each consideration, the Guide provides a range of options rather than one “right” way. In almost all cases, the options are not mutually exclusive, and it is advisable to adopt multiple approaches. As such, the Guide is applicable to a broad range of “health systems,” from solo practices to large group practices, from outpatient to inpatient settings, and from small clinics to large integrated health systems.

Finally, while the Guide draws primarily from the foundational resources, a selection of other relevant references are available on the Further Reading page.

Relevant Primary Resources by Topic for PROs in Clinical Care