Study Participant Feedback Questionnaire (SPFQ) Fostered More Patient Centric Approach to Study Design
Featured Solution: Study Participant Feedback Questionnaire (SPFQ)
One member company was looking to leverage decentralized clinical trial (DCT) elements into various studies in a way that would improve patient experience. They leveraged the Study Participant Feedback Questionnaire (SPFQ) from TransCelerate as a tool to incorporate collecting metrics for consideration and analysis.
At the time, there was no consistent standardized method within the company for collecting patient feedback and therefore a lack of incorporation of those metrics into study design. The team leveraged the SPFQ to spur internal discussions with both their data scientists and their medical writing teams. They were able to review the flexibility of the SPFQ bank of questions to apply certain questions that were relevant for specific studies (for example DCT related questions for DCT specific elements in a study). They then worked internally to establish the SPFQ as a standard participant feedback mechanism. They accomplished this by adding the SPFQ to the protocol template as an option for all studies, developing standard implementation guidelines, and customizing the SPFQ bank of questions into a company standard template. These steps were taken to ensure that there was broad consideration within the organization at the onset of study design and a path forward for assessing the SPFQ data. Furthermore, a working group was formed to consult with study teams on why and how the SPFQ is being considered and best practices for incorporating into a study. This created an environment where all teams needed to consider patient-centric design, with the goal of enhancing the value of the SPFQ to improve studies overall.
At this point in their journey, the member company has begun collecting data in two forms (digitally). In any study with electronic Clinical Outcome Assessment (eCOA) where the SPFQ is a part of the standard scope of work, the member company was able to ensure that the SPFQ form is automatically included with minimal cost and effort for the study team. In instances where eCOA is not being used, the member created a form that can be sent to sites for distribution to the participants to access using a QR code or URL link. When the SPFQ is incorporated, the member company is generally collecting data at the beginning, middle and end of the study, with flexibility as needed per study. A separate SPFQ statistical analysis plan has also been developed to focus on participant feedback data separate from clinical trial data and defines the regular check points for reviewing feedback.
The member company concludes that the incorporation of the SPFQ in the onset of study design is helping to foster a more patient centric approach by formalizing a mechanism for requesting and receiving feedback throughout the study process. It is also helping to contextualize and focus each team’s work on the patient in a way that potentially reduces patient burden and increases their likelihood of retention and continued participation.
