Electronic source materials in clinical research: Acceptability and validity of symptom self-rating in major depressive disorder

Abstract

Objectives Clinical research projects gather large amounts of data. Typically, information is captured on paper source documents for later transcription to an electronic format, where responses can be checked, and errors, omissions, and inconsistencies can be resolved. These steps contribute delays, cost, and complexity to clinical research, particularly in large-scale multi-site investigations. To address these issues, we used a mobile computing device with a touch-screen display (“tablet PC”) to capture clinical data from depressed patients directly into electronic format. We then examined ease of use, the equivalence of responses between paper and electronic methods, and the acceptability of the tablet PC for this clinical population. Settings Outpatient clinics at four medical centers. Methods 80 adults with major depressive disorder (MDD) completed the 16-item Quick Inventory of Depressive Symptomatology – Self-Rated (QIDS-SR 16), using both traditional paper forms and an electronic representation of the same questions; participants also completed a survey to evaluate their experience. Results QIDS-SR 16 responses from paper and electronic versions were highly correlated (mean total: 15.3 (SD = 5.2) electronic vs. 15.1 (SD = 5.2) paper format), and showed high inter-rating reliability for overall score (intra-class correlation 0.987 (with a 95%CI [0.979, 0.992])) and high degree of association for individual symptom items. Participants found both methods acceptable and overall found the electronic implementation easier to use. Conclusions QIDS-SR 16 values collected electronically from research participants were equivalent to those collected using traditional paper self-assessment forms. Participants with MDD found the tablet PC version to be acceptable and easier to use than the paper forms.