An electronic patient-reported outcome, ePRO for short, is the electronic capture of a health-related report directly by the trial participant, without interpretation of the response by medical personnel. ePRO thus describes the digital collection mode of a patient-reported outcome. The entry can be made, for example, via a provided mobile device, a tablet, a web application or an own device.<\/p>\n
A patient-reported outcome, PRO for short, is the content concept: a direct self-report on the state of health, for instance on symptoms, functioning or quality of life. ePRO does not change this concept, but determines how the response is captured and transmitted to the trial environment. The selection of the instrument must fit the trial objective, the target population and the intended context. A digital interface alone therefore does not automatically make a questionnaire a suitable endpoint instrument.<\/p>\n
The EMA treats ePRO as an electronic clinical outcome assessment and subjects the data to the same GCP expectations as other clinical data. The first durable, transmitted source data record and the associated metadata must be traceably determined. These include in particular user assignment, time point, instrument version, response status as well as technical events, if applicable. Electronic capture can reduce transmission errors and enable timely data availability, but does not exempt from the duty to ensure completeness and quality.<\/p>\n
The ePRO system must be suitable for its intended use. The sponsor must demonstrate on a risk basis that the requirements for capture, storage, transmission, user management, data protection and recovery are met. The validation refers not only to the application, but also to configuration, interfaces, versions, changes and the defined use in the trial context. Training and support of the participants are part of the concept, because a misunderstood operation can impair data quality.<\/p>\n
Time stamps document when a response was entered or transmitted. They enable the review of collection windows and help to distinguish retroactive bulk entries from timely entries. With bring your own device, BYOD for short, participants use their own compatible device. For this, in addition to technical compatibility, equivalent presentation, secure authentication, accessibility features, support, backup procedures in case of device or connection problems and potential selection bias must be evaluated. BYOD is thus a provision model, not a separate endpoint type.<\/p>\n
A PRO is the direct statement of the patient; it can be collected on paper or electronically. ePRO designates exclusively the electronic capture of such an outcome. Not every electronic patient report must be a formal PRO instrument with a regulatory-relevant endpoint, and not every PRO must be implemented as ePRO. For suitability, concept, measurement model, target population, collection mode and evidence for the intended purpose are decisive.<\/p>\n
An eDiary is a specific form of electronic data capture, which typically queries recurring diary entries such as symptoms, intakes or events in predefined time windows. It can contain ePRO data, but is narrower than ePRO: ePRO also includes electronic questionnaires at visits or other patient-side outcome collections. The terms must therefore not be equated. An eDiary can also capture reports that do not represent a validated PRO measurement.<\/p>\n
ePRO can make patient-reported data available in a timely and structured manner. In everyday trial life, comprehensible screen texts, appropriate reminders, robust time stamps, a clear definition of the source as well as regulated escalation paths for critical reports are central. Authorities expect the quality of the data, the suitability of the system and the reliability of the collection process to be demonstrable. Data changes should be limited and traceable; participants must not be burdened by unnecessarily complicated technology.<\/p>\n
Full-service CROs such as Mediconomics support the selection and setup of ePRO workflows, the evaluation of system and validation documents, the design of training and support as well as the alignment with data management, monitoring and biostatistics. Concrete services include the specification of data transfers, the review of time stamps and collection windows, the documentation of BYOD or backup device processes and the planning of data review up to database lock.<\/p>\n
Is ePRO the same as a patient-reported outcome?<\/strong><\/p>\n No. PRO describes the direct patient statement as an outcome concept. ePRO describes the electronic capture of this outcome. A PRO can also be collected on paper.<\/p>\n Why are time stamps important in ePRO?<\/strong><\/p>\n They prove the temporal context of an entry and support the check whether predefined collection windows were adhered to. Together with other metadata, they help to make the data history traceable.<\/p>\n Is BYOD readily permissible?<\/strong><\/p>\n BYOD can be used if suitability for the intended trial purpose is demonstrated and risks such as device differences, access, support and possible selection bias are adequately controlled.<\/p>\n An electronic patient-reported outcome, ePRO for short, is the electronic capture of a health-related report directly by the trial participant, without interpretation of the response by medical personnel. ePRO thus describes the digital collection mode of a patient-reported outcome. The entry can be made, for example, via a provided mobile device, a tablet, a web […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6929","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6929","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":2,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6929\/revisions"}],"predecessor-version":[{"id":7467,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6929\/revisions\/7467"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6929"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6929"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
\n