ePROs: What are Electronic Patient Reported Outcomes?
15 hours ago · The term patient-reported outcomes (PROs) refers to a health outcome directly based on patient self-reporting. PROs are a key aspect of clinical trials and treatments, and in modern health care settings, many organizations are transitioning away from pen-and-paper data collection methods and moving to electronic patient-reported outcomes (ePROs). >> Go To The Portal
ePRO (Electronic Patient-Reported Outcome)
- Customizability for ease of use and access.
- Improved reporting as patients and caregivers are able to report as an event is occurring.
- Real-time monitoring of patients.
- Greater compliance compared to traditional methods to capture patient-reported outcomes.
Electronic patient-reported outcomes (ePRO) are patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial. The technology used to gather ePRO can be an app that can be downloaded onto any device, such as a patient's iPhone.
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AnswerWhat is ePRO (electronic Patient Reported Outcomes)?
Participate™ electronic patient reported outcomes (ePRO) provides a fun and easy way for patients to contribute directly to your clinical trial. With Participate ePRO, you can send friendly, “just-in-time” notifications and reminders through SMS or email.
What are Patient-Reported Outcomes?
The term patient-reported outcomes (PROs) refers to a health outcome directly based on patient self-reporting. PROs are a key aspect of clinical trials and treatments, and in modern health care settings, many organizations are transitioning away from pen-and-paper data collection methods and moving to electronic patient-reported outcomes (ePROs).
What are the benefits of ePRO?
Your ePRO data is HIPAA compliant and fully auditable. A single audit trail clearly shows patient, clinician, and study team activity in a single view for easy clinical data analysis. together as one. Patient-reported data instantly becomes part of your overall study data set. Clinical data quality and security.
Can the ePRO tool be used in a single primary health care practice?
Using the tool, patients and providers collaboratively develop health care goals on a portal linked to a mobile device to help patients and providers track progress between visits. Objectives: This study tested the usability and feasibility of adopting the ePRO tool into a single interdisciplinary primary health care practice in Toronto, Canada.
How do you collect patient-reported outcomes?
Strategies for Collecting High-Quality Patient-Reported OutcomesSet Clear Goals. ... Use Validated Questions When Possible. ... Avoid Multiple Interpretations of Questions. ... Keep It Short and Sweet. ... Ensure Patient Understanding. ... Choose the Best Method for the Target Population. ... Protect a Patient's Right to Refuse. ... Conclusion.
What does ePRO stand for in clinical trials?
Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic TrialStudy Type :Interventional (Clinical Trial)Actual Enrollment :45 participantsAllocation:RandomizedIntervention Model:Parallel Assignment8 more rows
What is patient-reported outcome data?
A patient-reported outcome (PRO) is "an outcome measure based on a report that comes directly from the patient (e.g., study subject) about the status of the patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else,” according to the National Health Council. ...
What are patient related outcomes?
The U.S. Food and Drug Administration (FDA) defines a patient-reported outcome (PRO) as “any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else [1].” PROs typically include information about health- ...
What is the difference between eCOA and ePRO?
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.
What is ePRO healthcare?
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.
What are reported outcomes?
Patient-Reported Outcomes (PROs) are defined by the National Quality Forum as “any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.” Most healthcare organizations consistently measure things like ...
What are examples of PROMs?
Examples of such PROM instruments include “Starting the conversation,” a brief measure of dietary intake;62 “Exercise as the fifth vital sign,” a brief measure of physical activity;63 School Health Action, Planning and Evaluation System (SHAPES), a school-based self-report physical activity measure;64 and the Morisky ...
What is the purpose of PROMs?
Patient-reported outcome measures (PROMs) are used to assess a patient's health status at a particular point in time. PROMs tools can be completed either during an illness or while treating a health condition.
What are examples of patient outcomes?
Results. The attributes of patient outcomes include (1) patient functional status (maintained or improved), (2) patient safety (protected or unharmed), and (3) patient satisfaction (patient reporting of comfort and contentment).
What are examples of health outcomes?
Positive health outcomes include being alive; functioning well mentally, physically, and socially; and having a sense of well-being. Negative outcomes include death, loss of function, and lack of well-being.
What are examples of outcome measures?
Outcome Measures For example: The percentage of patients who died as a result of surgery (surgical mortality rates). The rate of surgical complications or hospital-acquired infections.
Why is patient acceptability important in epro?
This is important, as if significant numbers of patients refuse to take part in clinical trials because of dislike of computers then there will be bias in the study population.
What is an EPRO?
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.
What is ISPOR in medicine?
The International Society for Pharmacoeconomomics and Outcomes Research (ISPOR) has issued guidelines on establishing equivalence between modes of administration. Their approach is hierarchical, and depends on the degree of change made during the process of migration from paper to electronic format.
Can epro be used in clinic?
Larger devices are generally used in a clinic setting. Computers generally run dedicated ePRO applications - the use of the web for ePRO is not yet widespread. Typically a single question at a time is presented on the screen, with a set of possible response options.
Is EPRO a new instrument?
At the third level, where most change has occurred, the ePRO instrument must be treated as a new instrument, and complete psychometric validation carried out. There is a great deal of evidence supporting the general equivalence of paper and ePRO methods.
What are the benefits of epros?
Many PROs measure outcomes that can only be assessed by the patient, like pain levels, nausea , or fatigue. ePROs have the potential to improve care delivery by allowing clinicians to more closely monitor patient outcomes asynchronously, in real-time.
What is a PRO in medical terms?
PROs (patient-reported outcomes) are any treatment outcomes that are reported by the patient, without interpretation by a clinician. ePROs (electronic PROs) are captured electronically—rather than via paper forms—using a computer, tablet, smartphone, or other device. The terms PRO and ePRO are often used interchangeably.
Capture patient reported data quickly and accurately
Our electronic patient-reported outcome software is a unique survey builder that allows you to create complex surveys within seconds. A unique feature of ClinicalPURSUIT is that your survey questions are grouped and stored for later use anytime.
Drag-n-Drop Survey Creation
Need to ask demographics questions? Just pull up your demographic questions and drag and drop questions to your new survey.
Skip Logic and Complex Branching
Easily create complex skip logic by simply moving questions around a drag and drop menu system. Creating surveys has never been so easy.
Build
Design beautiful easy to take surveys that ask the right questions. Pull in subject data to personalize the survey experience and provide simple ongoing longitudinal data capture.
Analyze
Quickly use dashboards to track survey responses and natural history disease patterns. Uncover key trends as they happen in real time.
Pre-established Survey Questions
Save time by tapping in the ClinicalPURSUIT pre-populated survey questions.
Safe & Secure
Data is protected with enhanced security including encryption. Compliant with HIPAA and GDPR.
Overview
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
Methods
The two main methods currently used for ePRO are computers/Smartphones and telephone systems
Computers are most often touch-screen devices, ranging from wearables, hand-held devices and smartphones, through iPads and other Tablet computers. The smaller devices are often used as electronic diaries, designed to be used for symptom reporting on a daily basis. Larger devices ar…
Electronic diaries
Diaries are used when it is desirable to obtain frequent assessments over a period of time, for example when a condition fluctuates in severity. In such cases recall of severity over a period of time is unlikely to be accurate. Research has shown substantial bias in such summary recall, with ratings unduly influenced by how the patient is feeling at the time of making the rating, and by maximum severity rather than average severity during the assessment interval. Diaries can over…
Site-based
The other main setting for ePRO is the clinic, with questionnaires completed when patients come in for their scheduled visits. In this supervised situation, compliance is less of an issue. The questionnaires used in site-based ePRO are often longer and more complex than those used in diaries, assessing quality of life and activities of daily living, for example, in some detail. They more often include branching logic ("if YES continue with the next question, if NO, goto question 34"). …
Patient acceptability
From the early years of ePRO there has been concern about whether all patients can cope with computer technology. This is important, as if significant numbers of patients refuse to take part in clinical trials because of dislike of computers then there will be bias in the study population. One of the earliest ePRO studies used a LINC-2 minicomputer to collect patient data. The majority of patients preferred the computer to paper data collection. Similar findings have been reported fro…
Validity and equivalence
Establishing the validity of an ePRO instrument is in principle no different from that for other methods, such as paper. However most of the instruments in current use have been validated in paper form, and we need to ask (1) whether the paper data can be used to establish validity of the electronic version, and (2) whether data from paper and electronic versions can be used interchangeably.
In practice
Several successful regulatory approvals have used ePRO data in recent years, including ketorolac for ocular pain, eszopiclone for insomnia, milnacipran for fibromyalgia, estradiol/levonorgestrel for post-menopausal symptoms, and ruxolitinib for myelofibrosis. In the case of estradiol/levonorgestrel, detailed ePRO data on bleeding/spotting from a one-year clinical trial are presented in the patient information leaflet.
Further reading
• Byrom B, Tiplady B (eds.) ePRO: Electronic Solutions for Patient-Reported Data (2010) Farnham: Gower. ISBN 978-0-566-08771-4.
• Byrom B, Mühlhausen W Electronic Patient-reported Outcome Measures: An implementation handbook for clinical research(2018) ISBN 978-1-72028-110-8
• Stone AA, Shiffman S, Atienza AA, Nebeling L (eds.) The Science of Real-Time Data Capture (2007) Oxford: Oxford University Press. ISBN 978-0-19-517871-5
• Byrom B, Tiplady B (eds.) ePRO: Electronic Solutions for Patient-Reported Data (2010) Farnham: Gower. ISBN 978-0-566-08771-4.
• Byrom B, Mühlhausen W Electronic Patient-reported Outcome Measures: An implementation handbook for clinical research(2018) ISBN 978-1-72028-110-8
• Stone AA, Shiffman S, Atienza AA, Nebeling L (eds.) The Science of Real-Time Data Capture (2007) Oxford: Oxford University Press. ISBN 978-0-19-517871-5.
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