Digitization of patient-reported outcomes.

Health care is a data-intensive industry. The methods for collecting, storing, and retrieving clinical data have been evolving within a global electronic ecosystem comprising computers, mobile devices, the Web, social media, and a more connected world. The digitization of health care is nearly complete. Imaging studies, laboratory assays, drug delivery systems, diagnostic devices, robot-assisted surgery, computer-assisted prosthetics, and biomonitors all rely on computers and electronic data systems. The biggest holdout for the digital health care transformation has been the routine clinical data derived from patients and recorded in health records. National policy such as the Health Information Technology for Economic and Clinical Care [1] and the Affordable Care Act of 2010 have led to a rapid acceleration in the amount of clinical information that is captured electronically and potentially usable in meaningful ways. The day when the business of health care is conducted without paper seems near at hand. Digitization of health care will transform the research enterprise, because clinical data will be available on millions of patients and their encounters. Less clear is how patients’ perspectives on their treatment preferences, health, well-being, and behavior, captured by patient-reported outcome (PRO) measures, will be obtained from electronic data systems, so-called ePRO systems. Progress implementing ePROs into clinical practice has been made in such fields as oncology [2], which benefits from standardized approaches to symptom assessment, but these efforts remain in their nascent stages of development. PROs evolved from the tradition of questionnaire-based testing, and until recently, virtually all PRO data were obtained via paper-and-pencil methods. Today, there are a variety of electronic data capture systems for PROs, including interactive voice response systems, handheld and tablet devices, and Webenabled technologies. These are available for clinical research and increasingly clinical practice. In recognition of the need for demonstrating the validity of new electronic data collection systems, both for ensuring highquality research and addressing regulatory requirements for using these technologies for labeling purposes, the Systems Validation Task Force of ISPOR has produced a set of recommendations for validating ePRO systems [3]. Zbrozek et al. [3] have provided producers and users of ePRO systems in clinical trials a comprehensive and thoughtful guide on design principles, documentation requirements, and evaluation of the data quality and validity of these tools. It is a unique contribution to the literature, and the Task Force should be applauded for its members’ hard work to achieve these consensus-derived principles. Although the article is targeted at ePRO systems used in clinical trials, it is likely that anyone who develops or uses ePROs will find the guidance useful.