Electronic Patient-Reported Outcome (ePRO) Data Collection System
An Electronic Patient-Reported Outcome (ePRO) Data Collection System is an electronic data capture system that is used to collect PRO data in electronic format.
- Context:
- It can range from being a Screen-based ePRO System to being a Telephone-based ePRO System.
- It can range from being a Site-based ePRO System to being a Remote ePRO Data Collection System.
- It can range from being a Device-based ePRO System to being a Web-based ePRO System.
- It can be integrated into an Electronic Clinical Outcome Assessment (eCOA) System.
- …
- Example(s):
- Counter-Example(s):
- See: ISPOR ePRO Good Research Practices Task Force, Decentralized Clinical Trial, Electronic Informed Consent (eConsent), Bring Your Own Device (BYOD) Clinical Trial, Direct-to-Patient Digital Clinical Trial, Cloud-based Digital Patient Recruitment and Engagement Platform, Clinical Trial Management System (CTMS), Interactive Voice Response (IVR) System, Patient eDiary, Software as a Medical Device (SaMD), Digital Biomarker Collection System.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Electronic_patient-reported_outcome Retrieved:2021-12-12.
- An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data.
2021b
- (Signant Health, 2021) ⇒ https://www.signanthealth.com/solutions/clinical-outcome-assessments/smartsignals-ecoa-ecoa/ Retrieved:2021-12-12.
- QUOTE: The difference between Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO) is that ePRO systems are a type of eCOA. Clinical trial patients often use eCOA system technologies on mobile devices to remotely send their ePRO symptoms and experience directly to site staff. Other types of COAs include Electronic Performance Outcome (ePerfO), Electronic Clinician-Reported Outcome (eClinRO), and Electronic Observer-Reported Outcome (eObsRO).
2018
- (Coravos, 2018) ⇒ Andrea Coravos (January 23, 2018). “Clinical trials are in need of a digital makeover". In: Digital Initiative - Harvard Business School.
- QUOTE: This category includes electronic data capture (EDC) systems and other platforms that will store patient-level data. It also includes digital tools that collect eCOAs (Electronic Clinical Outcomes Assessment) and ePROs (electronic Patient Reported Outcome)/PROM (Patient Reported Outcome Measures) data. Many companies have created products that span across the patient and outcomes data layer.
There are a number of big EDCs that have been in the industry for a long time: Medidata, Oracle, RedCap, and eClinicalSolutions. Some companies, like Veeva Systems, have been modernizing the tools for SaaS in global life sciences, expanding out its cloud-based platform.
Aside from the big players, there has been a rise in software tools to capture patient outcomes. CRF Health is one of the leaders in eCOA and ePRO assessments. Bracket is one of the leading providers of eCOA, rater training, and trial supply management solutions for biopharma sponsors — with a focus on CNS therapies. Altavoz is also building an eCOA platforms. uMotif is building a “next-generation” patient data capture platform with many tools designed for clinical research. The International Consortium for Health Outcomes Measurement (ICHOM) has published a number of companies that have web and mobile-based reporting systems for outcome measurements on the ICHOM TechHub.
Outcomes are also influenced by med adherence technologies, and there are a number of new tools that are designed to improve adherence. AiCure is an advanced medication adherence solution powered by artificial intelligence, which visually confirms medication ingestion on any smartphone. Dan Gebremedhin and Kara Werner from Flare Capital recently conducted a deep-dive in medical adherence tools on the market. These types of technologies are in many ways more similar to digital biomarkers than to the big patient data capture databases.
- QUOTE: This category includes electronic data capture (EDC) systems and other platforms that will store patient-level data. It also includes digital tools that collect eCOAs (Electronic Clinical Outcomes Assessment) and ePROs (electronic Patient Reported Outcome)/PROM (Patient Reported Outcome Measures) data. Many companies have created products that span across the patient and outcomes data layer.
2015
- (Coons et al., 2015) ⇒ Stephen Joel Coons, Sonya Eremenco, J. Jason Lundy, Paul O'Donohoe, Hannah O'Gorman, and William Malizia (2015). "Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials". In: The Patient - Patient-Centered Outcomes Research volume 8(4). DOI:10.1007/s40271-014-0090-z.
- QUOTE: In clinical research, PRO data collection can occur at a study site (e.g., clinic) or off-site in an unsupervised setting (e.g., subject's home, workplace, or school). To enable more timely and accurate self-reporting and to avoid potential recall bias, off-site assessment of symptom or functional endpoints is often optimal. For either study site or off-site (i.e., remote) PRO data collection, ePRO platforms are recommended over paper-based approaches, but it is especially critical for unsupervised, remote data entry due to the reasons discussed above.
A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response (IVR) systems and screen-based systems. Within the screen-based approaches are device-based systems (i.e., proprietary software installed on a specific hardware platform), Web-based systems, and downloadable application (app)-based systems that utilize the subject’s or site’s screen-based device. The different types of available ePRO data collection technologies are described briefly below; further description of these technologies is provided by Eremenco and colleagues (2014). Since using downloadable apps for collecting PRO data in clinical trials is an emerging methodology, this topic is only mentioned briefly in the descriptions below, but will be covered in more depth in the context of bring your own device (BYOD) trials later in this article(...)
Advances involving the integration of wireless and cellular phone capabilities expanded their utility exponentially since they allowed data to be transferred immediately from the device to a central server/database. Hence, most of these handheld devices are now mobile telephones (e.g., smartphones) and they have become the mainstay of ePRO data collection. Their portability and touch screen functionality provide a significant advantage over other data collection modes, particularly for clinical trials requiring frequent remote PRO data capture (e.g., symptom or event-based diaries).
- QUOTE: In clinical research, PRO data collection can occur at a study site (e.g., clinic) or off-site in an unsupervised setting (e.g., subject's home, workplace, or school). To enable more timely and accurate self-reporting and to avoid potential recall bias, off-site assessment of symptom or functional endpoints is often optimal. For either study site or off-site (i.e., remote) PRO data collection, ePRO platforms are recommended over paper-based approaches, but it is especially critical for unsupervised, remote data entry due to the reasons discussed above.
2014
- (Eremenco et al., 2014) ⇒ Sonya Eremenco, Stephen Joel Coons, Jean Paty, Karin Coyne, Antonia V. Bennett, Damian McEntegart, and ISPOR PRO Mixed Modes Task Force (2014). "PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO mixed modes good research practices task force". In: Value in health, 17(5). DOI:10.1016/j.jval.2014.06.005.
- QUOTE: In February 2011, the ISPOR Health Science Policy Council recommended to the ISPOR Board of Directors that an ISPOR Good Research Practices Patient-Reported Outcomes (PRO) Task Force be established to focus on mixed modes of PRO data collection and to provide good research practice recommendations for the analysis of mixed modality data.
2009
- (Coons et al., 2009) ⇒ Stephen Joel Coons, Chad J. Gwaltney, Ron D. Hays, J. Jason Lundy, Jeff A. Sloan, Dennis A. Revicki, William R. Lenderking, David Cella, Ethan Basch, and ISPOR ePRO Task Force (2009)."Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report". In: Value in Health, 12(4), 419-429.
- QUOTE: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims"]. The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted.