Comparing the measurement equivalence of EQ-5D-5L across different modes of administration.

Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required.

"Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?

Field-based patient-reported outcome (PRO) assessments, including measures of signs, symptoms, and events that are administered outside of the research clinic, can be critical in evaluating the efficacy and safety of new medical treatments. Collection of this type of data commonly involves providing subjects with stand-alone electronic devices, such as smartphones, that they can use to respond to assessments in their home or work environment. Although this approach has proven useful, it is also limited in several ways: For example, provisioning stand-alone devices can be costly for sponsors, and requiring subjects to carry a device that is exclusively dedicated to the study can be burdensome.

Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints.

For a number of compelling scientific, operational, and regulatory reasons, the use of electronic data capture is becoming the preferred means of collecting clinical outcome assessment (eg, patient-reported outcome [PRO]) data in clinical trials. Electronic PRO (ePRO) data collection leverages screen-based technologies (eg, handheld devices, tablet computers, and web-based systems) and telephone-based (eg, interactive voice response) systems. Data collection is routinely either site based (ie, clinical study site) or field based (eg, subject's home, school, or workplace).

Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.

Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures.