Electronic Patient-Reported Outcome (ePRO) Measure
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An Electronic Patient-Reported Outcome (ePRO) Measure is a PRO instrument that is an electronic survey.
- Context:
- It is a disease-specific, health condition, or generic measure that is based on a report that comes directly from the patient.
- It requires a ePRO Data Collection System.
- …
- Example(s):
- Medable ePro.
- …
- Counter-Example(s):
- See: Decentralized Clinical Trial, Medable Inc., eConsent, Electronic Clinical Outcome Assessment (eCOA) System, Electronic Data Capture (EDC) System, Direct-to-Patient Digital Clinical Trial, Cloud-based Digital Patient Recruitment and Engagement Platform, Siteless Clinical Trial, Clinical Trial Case Report Form (CRF), Clinical Trial Management System (CTMS), Interactive Voice Response (IVR) 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
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Patient-reported_outcome Retrieved:2021-12-12.
- A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting.
2021c
- (NCBI, 2021) ⇒ https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.patientreported-outcome/
- QUOTE: A type of clinical outcome assessment. A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response. Symptoms or other unobservable concepts known only to the patient can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. PRO measures include:
- Rating scales (e.g., numeric rating scale of pain intensity or Minnesota Living with Heart Failure Questionnaire for assessing heart failure)
- Counts of events (e.g., patient-completed log of emesis episodes or micturition episodes)
- QUOTE: A type of clinical outcome assessment. A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response. Symptoms or other unobservable concepts known only to the patient can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. PRO measures include:
2020
- (Cochrane PRO-MG, 2020) ⇒ https://handbook-5-1.cochrane.org/chapter_17/17_1_what_are_patient_reported_outcomes.htm
- QUOTE: Patient-reported outcomes (PROs) are any reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient’s responses by a clinician, or anyone else. PROs include any treatment or outcome evaluation obtained directly from patients through interviews, self-completed questionnaires, diaries or other data collection tools such as hand-held devices and web-based forms (US Food and Drug Administration 2006). Proxy reports from caregivers, health professionals, or parents and guardians (necessary in some conditions such as advanced cancer and cognitive impairment) cannot be considered PROs and should be considered as a separate category of outcomes.
PROs provide patients’ perspective on treatment benefit; directly measure treatment benefit beyond survival, disease, and physiologic markers; and are often the outcomes of greatest importance to patients. Reports from patients may include the signs and symptoms reported in diaries, the evaluation of sensations (most commonly classified as symptoms), reports of behaviours and abilities (most commonly classified as functional status), general perceptions or feelings of well-being, and other reports including satisfaction with treatment, general or health-related quality of life, and adherence to treatments. Reports may also include adverse or side effects (see Chapter 14).
PROs are sometimes used as primary outcomes in clinical trials, particularly when no surrogate measure of direct benefit is available to capture the patient’s well-being. More often, PROs complement primary outcomes such as survival, disease indicators, clinician ratings and physiologic or laboratory-based measures. Figure 17.1.a shows those outcomes that are considered most often as important to patients within a classification of all outcomes.
PROs may be collected using a measure (or instrument) that is disease-specific, condition-specific or generic. Disease-specific measures describe severity, symptoms, or functional limitations specific to a particular disease state, condition or diagnostic grouping (e.g. arthritis or diabetes). Condition-specific measures describe patient symptoms or experiences related to a specific condition or problem (e.g. low-back pain) or related to particular interventions or treatments (e.g. knee-replacement or coronary artery bypass graft surgery). Generic measures are designed for use with any illness group or population sample.
- QUOTE: Patient-reported outcomes (PROs) are any reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient’s responses by a clinician, or anyone else. PROs include any treatment or outcome evaluation obtained directly from patients through interviews, self-completed questionnaires, diaries or other data collection tools such as hand-held devices and web-based forms (US Food and Drug Administration 2006). Proxy reports from caregivers, health professionals, or parents and guardians (necessary in some conditions such as advanced cancer and cognitive impairment) cannot be considered PROs and should be considered as a separate category of outcomes.
2018
- (FDA, 2021) ⇒ https://www.fda.gov/drugs/development-approval-process-drugs/patient-focused-drug-development-glossary Content current as of: 06/08/2018.
- QUOTE: Patient-reported outcome (PRO): A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without interpretation of the patient's response by a clinician or anyone else. A PRO can be measured by self-report or by interview, provided that the interviewer records only the patient's response. Symptoms or other unobservable concepts known only to the patient (e.g., pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others (...)
2017
- (Gwaltney et al., 2017) ⇒ Chad Gwaltney, James C. Mundt, John H. Greist, Jean Paty, and Brian Tiplady. (2017). “Interactive Voice Response and Text-based Self-report Versions of the Electronic Columbia-Suicide Severity Rating Scale Are Equivalent.” Innovations in clinical neuroscience 14, no. 3-4
- QUOTE: ... The most widely used SIB-specific measure is the Columbia Suicide Severity Rating Scale (C-SSRS).4 The original C-SSRS is a paper and pencil measure that is completed by a clinician through a semi-structured interview with a patient. An electronic version of the measure—the eC-SSRS — was developed as an interactive voice response (IVR) system alternative that is completed directly by the patient through a structured, standardized, automated interview. ...
2009
- (Coonsoel et al., 2009) ⇒ Stephen J. Coonsoel, Chad J. Gwaltney, Ron D. Hays, J. Jason Lundy, Jeff A. Sloan, Dennis A. Revicki, William R. Lenderking, David Cella, and Ethan Basch. (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.” Value in Health 12, no. 4
- QUOTE:
- Background: 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.
- Conclusions: The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.
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