Learning pains: system design, management, and lessons learned using electronic patient reported outcomes in the QUEST study of chronic post-amputation pain

Abstract

Abstract Background Studying pain clinically can be challenging. Typically, studies use paper diaries and measure pain from baseline and some pre-specified study endpoints. Both can lead to inaccuracies if studying on-demand device use. The QUEST study evaluating the safety and effectiveness of the investigational Altius device for treating chronic post-amputation pain (PAP) became, to our knowledge, the first longitudinal study to capture and validate repeated measurements using electronic patient-reported outcomes (ePRO). Methods The system was designed to capture pain episodes, device use, pain medication use and prosthetic use in “real-time.” Subjects received an electronic diary (eDiary) during screening and were required to demonstrate compliant reporting, and requisite pain levels to progress towards device implantation. Data were collected and merged with Altius session data and study visit data for 3 Month Primary Endpoint analysis. Compliance data across Device Treatment and End-of-Day Reports were also collected. Results eDiary Eligibility pass rate during screening was 82% (410/497 subjects). Subjects generated 1,773,356 datapoints and 197,952 reports throughout QUEST. A total of 14,337 device uses were captured during Randomized Testing, with 77.0% and 82.7% compliant Device-use Reports and End-of-Day Reports captured, respectively. QUEST results are presented elsewhere (clinicaltrials.gov Identifier NCT 00221934). Conclusions Neuros and partner vendors developed a unique system to capture accurate, “real-time” pain and treatment data from subjects with chronic PAP, despite health and technical-related challenges. This system provided a robust data set not yet seen in chronic pain literature and could provide a framework for better understanding chronic pain. Clinical Trial Information ClinicalTrials.gov ID NCT02221934, Registration Date: 2014–08-15.