Paper Patient-Reported Outcomes: Golden No More
“We must do all that we can to make patient-reported outcome assessment feasible and credible. If we fail in our task we will have left out the heart of all healthcare research: the patient.” This quote, from Sloan and colleagues, is a powerful reminder of the importance of patient-reported outcomes (PROs), particularly as the chorus calling for patient-centered research grows. The delivery mechanism is inextricably linked to PROs’ feasibility and credibility. Paper, in addition to being the original mode, has long been the gold standard for PRO data capture, but times have changed and the credibility of paper has never been lower. Look around — in every coffee shop, every sidewalk, every public place, people have their heads buried in smartphones. They are using technology for most everything in their day-to-day lives: work, shopping, entertainment, socializing… Yet when patients participate in a trial, they are told their data are critically important and are handed paper to record it. What messages does this send and how does it impact the quality of the data? Paper has always been imperfect but, in context of modern, consumer-oriented technology, it is rapidly becoming an anachronism. Why has paper persisted? The life sciences industry is slow to change—often for good reason—but ePRO solutions have been around for decades. The benefits of ePRO are well-documented and the FDA eSource guidance is clear, yet up to half of studies still use paper. Why? Expensive and time-consuming, traditional ePRO solutions were designed to address the most demanding and complex PRO challenges and, as a result, are ill-suited to the needs of many trials. Trials with less complex needs or smaller volumes of assessments have been unable to justify the ROI required for these solutions so they fall back to the only real alternative, paper. New Model for ePRO Paper is flawed and traditional ePRO doesn’t fit, but there is good news: well-suited to displace paper, a new model for ePRO has arrived. Unified with EDC, the new model has the following benefits:
- As easy to deploy and to use as paper
- An ROI to displace paper
- eSource data quality
Clinical trials are, fundamentally, a data collection exercise so optimizing data quality is paramount. To accurately capture the patient experience especially as the number of studies with PRO endpoints grows, along with patients’ expectations, the time has come to eliminate paper PROs.
*Guest blogger David McNierney is a product and solutions marketing director at Medidata. You can reach David by email or follow him on Twitter @davidmcnierney. And check out these additional blog posts by David.