The PROTEUS Consortium: Helping You Navigate the Use of Patient-Reported Outcomes in Clinical Trials and Clinical Practice

Claire Snyder, PhD; Michael Brundage, MD MSc; and Norah Crossnohere, PhD
PROTEUS Leadership

Patients, clinicians, health system administrators, regulators, and policy makers value information regarding the impact of disease and treatment from the perspective of patients. Patient-reported outcome (PRO) assessments have, therefore, become critical endpoints assessed in research studies and are increasingly integrated into clinical care to monitor patients and inform their management. However, PROs can only be used effectively if they are measured appropriately and reported clearly. Methodologic tools have been developed by ISOQOL and others to improve the assessment and interpretation of PROs in research studies (particularly clinical trials and comparative effectiveness studies) and in clinical practice.

To ensure that patients, clinicians, and other decision-makers have PRO data to make the best decisions they can about treatment options, the PROTEUS Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders) is partnering with 37 key patient, clinician, research, health system, funding, and regulatory groups from the U.S. and internationally, including ISOQOL. PROTEUS’s most immediate function is to disseminate and facilitate use of the methodologic resources and materials through direct engagement with stakeholders and through its website (TheProteusConsortium.org).

These are the trials-related core methodologic tools:¹

• SPIRIT-PRO Guidance² for writing PRO aspects of protocols
• ISOQOL Minimum Standards for PRO Measures in PCOR/CER³ to inform PRO measure selection
• SISAQOL Consortium Guidance⁴ for analyzing PRO data
• CONSORT PRO Guidance⁵ and Stakeholder-Driven, Evidence-Based Standards for Presenting PROs in Clinical Practice⁶ for reporting PRO findings
• Clinician’s Checklist for Reading and Using an Article About PROs⁷ for interpreting PRO papers

PROTEUS has also developed guidance for including and reviewing PRO endpoints in grant applications.⁸

These are the practice-related core methodologic tools:

• ISOQOL Users Guide for Implementing PRO Assessment in Clinical Practice⁹ step-by-step guide to the considerations involved in, and options for, implementing PROs in routine care
• User’s Guide for Integrating Patient-Reported Outcomes in Electronic Health Records¹⁰ step-by-step guide to the considerations involved in, and options for, integrating PROs in electronic health records
• Stakeholder-Driven, Evidence-Based Standards for Presenting PROs in Clinical Practice⁶ recommendations for displaying PRO data to promote understanding and use
• Medical Care Supplement “A PRO-cision Medicine Methods Toolkit”¹¹ a range of approaches for interpreting and acting on PRO data in clinical practice
• ePROs in Clinical Care¹² website aimed at helping health systems with PRO intervention design

In addition to providing links to the above tools, the PROTEUS website provides checklists, templates, brief web tutorials, handbooks, and other resources to help navigate the use of PROs in clinical trials and clinical practice. We invite you to visit TheProteusConsortium.org frequently as we are constantly adding information and resources. You can also join the mailing list for our bimonthly newsletter, PRO-cisely PROTEUS, on the website.

To view our references, please click the button below.

Support: PROTEUS has received funding from the Patient-Centered Outcomes Research Institute and unrestricted grants from Genentech and Pfizer.

This newsletter editorial represents the views of the author and does not necessarily reflect the views of ISOQOL. 

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