Electronic patient-reported outcome
ePRO is a method of collecting patient-reported outcome data through electronic means, often used in clinical trials and healthcare. Linguistic validation is a common process for ePRO questionnaires in the regulatory process. The collected data is considered Electronic Source Data for clinical trials.
The two main methods used for ePRO are computer devices such as touch-screen devices, smartphones, and tablets, and telephone systems using an IVR system. Computers are mostly used as electronic diaries and run dedicated ePRO applications, while IVR systems are used for both diaries and clinic settings. Additionally, there are custom devices specifically designed for ePRO data collection.
Diaries are used to obtain frequent assessments over a period of time and electronic diaries improve compliance compared to paper diaries. Electronic diaries automatically time-stamp entries, ensure valid and in-range data, provide reminders to patients, transfer data promptly to a central server for analysis, and eliminate manual data editing, reducing errors. ePRO applications typically achieve high compliance rates over 80% and often over 90%.
Interactive voice response
Interactive Voice Response (IVR) is a technology that allows telephone users to interact with a computer-operated telephone system through voice or keypad inputs. IVR provides a way for customers to interact with a company’s host system, allowing access to services via a telephone keypad or speech recognition. IVR systems can respond with pre-recorded or dynamically generated audio to guide users, and are capable of handling large call volumes for both inbound and outbound calls, being more intelligent than some predictive dialer systems.
IVR systems can be used as standalone systems to provide self-service solutions for various applications such as mobile purchases, banking payments, services, retail orders, utilities, travel information, and weather conditions. When combined with other systems like an automated attendant and ACD, IVR systems can optimize call routing for improved caller experience and workforce efficiency. The term Voice Response Unit (VRU) is also sometimes used.
IVR systems use DTMF decoding and speech recognition to understand the caller’s responses, and TTS (Text-to-Speech) to speak information to the caller. IVR can be deployed on-premises, in PSTN, or as an ASP. IVR can be used to front-end a call center operation, by identifying the caller’s needs and providing information such as account balances, reducing the need for operator intervention. IVR call flows are designed using directed, open-ended, or mixed dialogue prompts, and can be created using standards like VoiceXML, CCXML, SRGS, and SSML. The audio response unit (ARU) is a device that provides synthesized voice responses and increases the efficiency of information retrieval.
Electronic diaries
Diaries are commonly used to record assessments over time, and electronic diaries provide a more accurate and compliant way to do so compared to paper-based diaries. They have benefits such as automatic time-stamping, in-range data validation, reminders, prompt data transfer, and elimination of manual data entry. This makes electronic diaries useful for regulatory applications and helps achieve high compliance rates.
Site-based
Site-based ePRO is usually conducted in a clinical setting where patients come in for their scheduled visits, making compliance less of an issue. The questionnaires used are often longer and more complex than those used in diaries and assess quality of life and daily activities in detail, often using branching logic to guide patients through the questionnaire. This makes the experience easier for patients. Electronic features like automatic data entry, prevention of out-of-range or inconsistent entries, and prompt data transfer to a central server help reduce missing data and manual errors. This improves the overall quality of the questionnaire data collected.
In conclusion, establishing the validity of an ePRO instrument involves a multi-step process that can vary depending on the degree of change made in migrating from paper to electronic format. The International Society for Pharmacoeconomomics and Outcomes Research (ISPOR) provides guidelines on equivalence between modes of administration. Evidence supports the general equivalence of paper and ePRO methods, but each case must be evaluated on an individual basis. Validity must also be maintained in all target language populations through the process of Linguistic Validation. It is not always necessary to validate an ePRO measure against a pre-existing paper version, and new instruments can be developed from the beginning in electronic form or in parallel for both paper and electronic use.
