May 14 2024
Written by Kandie Dempsey and Marcie W. Ritter
NRG Patient Reported Outcomes (PRO) Compliance Officers Marcie Ritter and Kandie Dempsey have been evaluating opportunities to improve PRO data compliance. Patient Reported Outcomes (PROs) are, “a type of clinical outcome assessments based on a report that comes directly from the patient about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else.” (1)NRG trials that incorporate PROs currently use paper questionnaires sometimes supplemented by Medidata Patient Cloud (ePRO)(2) or Visiontree(3) electronic data capture that provides protocol participants with the ability to complete PRO surveys electronically from their personal device. Clinical Research Professionals at the research sites then can monitor data submissions in real-time to ensure the data is submitted within the protocol parameters.
Historically, the PRO compliance efforts focused on supporting remediation of delinquency. Going forward, there will be more focus on compliance – the percentage of expected PRO and NCF assessments that are collected and submitted. This initiative is expected to assist with improving overall compliance over time.
At the request of Patient Centered Outcomes Research Committee (PCOR) leadership, Ben Movsas and Ron Chen and in collaboration with NRG statistician, Stephanie Pugh and NRG programmer Josh Killion, a quarterly Compliance PRO Report has been developed for all NRG sites and trials that will be reviewed by the PCOR leadership. This compliance report was designed to reflect only those assessments that sites could have been expected to collect. Therefore, assessments were excluded from this report for the patients who were reported to be deceased, hospitalized, on hospice/palliative care, or had withdrawn consent. Moving forward these new reports will be used to assess site compliance for both PROs and Neurocognitive Function (NCF) assessments. Over the two-year time-period between 2022 and 2024, overall PRO compliance improved from 74% to 85.7% and data delinquencies decreased from 10.2% to 0.5%. This was due in large part to the prompt attention of dedicated site staff to remedy delinquencies when asked and who adapted their collection methods to improve compliance.
These successes were an outcome of the primary goals set to ensure timely, complete, and high-quality data submissions. Initiatives that contributed to the success of these outcomes included monitoring data submissions for all NRG trials that includes PROs, Quality of Life (QOL) and Neurocognitive Functioning (NCF) at least bi-monthly; developing positive rapport with sites; developing and providing education to sites or individuals tailored to their specific needs; and serving as resources to identify other content experts for guidance and education as needed.
Surveys were developed and administered to clinical research professionals to learn sites’ educational needs at two separate time-points. As a result of the feedback received, best practice tools and quick reference sheets were developed including: PRO Frequently Asked Questions (FAQ), Patient Cloud Handout, Best Practices for Collecting PROs via Telephone or Email, some protocol-specific quick reference sheets, and reminders for key points on trials with PROs as (co-) primary outcome measures in addition to educational brochures for PROs and NCF.
Presentations are provided at a variety of sessions at each NRG Group Meeting. Round-table sessions are held, which gives an opportunity to share best practices across sites and provides the opportunity for one-to-one engagement. The PCOR Committee has developed a PRO video that is an excellent resource for investigators at sites who are interested in becoming a PRO study chair or who may be considering adding PROs to their study, and it may be accessed on the NRG website nrg2024winter.s3.amazonaws.com/PCOR+NRG2024.mp4
Another significant NRG PRO resource is the NRG Oncology Protocol Support Committee (PSC). The PSC developed an NRG Oncology Clinical Research Coordinator Mentor Program – the program provides one-on-one support and guidance to Clinical Trial Nurses (CTN) and Clinical Research Associates (CRA) who are new to NRG Oncology and/or Clinical Trials, who have questions about the processes and procedures involved with trials and who could benefit from an experienced CTN or CRA. This program is valuable to individuals who are not new to NRG Oncology but have changed roles and responsibilities. This program is recommended to participating sites having difficulty with accrual, data delinquency rates, or that have experienced and unsatisfactory audits. There is an on-line request form. Individuals are matched to mentors according to the individual needs experienced.
Several future goals are in development. A new system is being piloted to provide sites with a quarterly PCOR report evaluating PRO compliance. The aim is to have 90% or higher compliance. Sites with compliance at or below 80% compliance will be monitored and provided with resources to assist with improvement.
High-priority trials that include PROs will be monitored for compliance. Reminder letters are being sent to sites providing important information about key PRO or NCF assessment measures and timepoints to assist with compliance.
A PRO Education Module is in development that will provide sites with electronic on-demand access to training. Once completed it will be available through CLASS on CTSU.
Many steps have been taken to improve PRO compliance, however the results can also be attributed to the personnel at the sites who ensure that the protocol requirements are followed, that protocol participants have the tools downloaded to their devices and that they monitor study calendars and requirements to ensure data is submitted as required, and if not, to contact patients personally as needed. We appreciate your contributions that help to ensure PRO research data validity and reliability. Know that NRGs persistence in contacting sites should not be overlooked, as evidence supports it is contributing to significant improvement in study outcomes. Finally, do not hesitate to reach out to the PRO Compliance Officers if assistance is needed. We cannot do this without you!
The compliance officers, the PCOR Chairs and the NCORP chairs would like to recognize the following 459 sites for their above-standards PRO compliance for forms expected since the spring of 2022.
Click here to view the list of all sites with above-standards PRO compliance.
CONTACT:
Patient Reported Outcomes (PRO) Compliance Officers
Kandie Dempsey
dempseyk@nrgoncology.org
Marcie W. Ritter
ritterm@nrgoncology.org
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