October 21, 2016 -
During our SWOG meeting in Chicago last month, the symptom control and quality of life committee and the patient advocate committee co-sponsored a special symposium entitled ďPatient-Reported Outcomes Symposium: Approaches, Tools, Electronic Data Capture.Ē We organized the event for a few reasons. The central one: these health-related outcomes are valuable tools that can improve our trials Ė and make our work truly patient focused.
Patient-reported outcomes, or PROs, are any trial outcomes reported by participants. A subset of PROs are Health-Related Quality of Life (HRQOL) measures, which help investigators evaluate the impact of illness or treatment on the physical, emotional, and social aspects of quality of life (QoL). PROs are broadly applicable across SWOG, both to disease and cancer control committees. In the disease committees, PROs are used to understand key domains of patient experience and QoL as a secondary endpoint, and also enhance understanding of some dimensions of drug toxicity when comparing different anti-cancer therapeutics. In symptom research, PROs are often appropriate primary endpoints of interventional studies taking aim at specific symptoms.
Because PROs can clarify and deepen our understanding of the impact of treatments, their use is on the rise. PROs even landed a high-profile plenary spot this month at ESMO 2016 in Copenhagen, when CheckMate researchers announced that head and neck cancer patients treated with nivolumab stayed healthier longer, and experienced less pain, fatigue, and insomnia than patients receiving standard treatment. There are also exciting developments in the field of PROs, including the rollout of a patient-reported version of the Common Terminology Criteria for Adverse Events called PRO-CTCAE. The PRO-CTCAE does not replace the CTCAE entirely, but it improves certain toxicity assessments that are best reported directly by the patient. Finally, we held the symposium to address a key issue facing all of us in SWOG Ė how and when to incorporate PRO assessments into our therapeutic trials. This is an especially important topic in an atmosphere of limited resources and increasing trial complexity.
So we had a lot to talk about in Chicago. And the symposium featured a number of excellent presentations. You can view the audio and slides on the web.
(Thanks to The Hope Foundation and the presenters for their support and generosity).
The symposium opened with a presentation from Dr. David Cella of Northwestern University, who provided an overview of development of PRO measures, including the NIH-supported PROMIS measures. Dr. Ethan Basch of the University of North Carolina followed with a description of the recently developed PRO-CTCAE. SWOGís biostatistician Dr. Joe Unger provided a summary of the issues facing SWOG with the increasing use of PRO measures in our clinical trials, which has led to an increased burden on staff at the SWOG statistics and data management center in Seattle, and the changes he is implementing to streamline the process. Dr. Lori Minasian from NIH explained the NCIís view of how best to incorporate PRO in trials, including new details about upcoming electronic data capture of answers directly from study participants. And SWOG advocate Sandra Hamilton provided key insights into the importance of PROs from the patientís perspective.
Some key messages from the session:
We encourage anyone who is interested in considering PROs in their SWOG research to reach out to the symptom control and quality of life committee for advice and guidance early in the process of developing your study. We can be contacted at email@example.com or firstname.lastname@example.org.
- Incorporation of PROs can add an important dimension to the interpretation of trial results, but it is important to be mindful of patient burden.
- There are different validated PRO instruments in use, and SWOG and other members in the NCIís National Clinical Trials Network are striving for consistency across trials as much as possible, especially within disease types.
- When PROs are used, itís important to collaborate early with colleagues who have specific content and methodological expertise.