electronic patient report outcome

by Onie Heller Published 3 years ago Updated 2 years ago 4 min read

Electronic patient-reported outcome - Wikipedia

24 hours ago · ePROs: What are Electronic Patient Reported Outcomes? January 24, 2020 | Cancer, Clinical Teams, Patient Experience, Technology. 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 … >> Go To The Portal

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.

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.

Full Answer

What is an electronic patient summary?

Technical Safeguards

Access Control. A covered entity must implement technical policies and procedures that allow only authorized persons to access electronic protected health information (e-PHI). ...
Audit Controls. ...
Integrity Controls. ...
Transmission Security. ...

Can electronic health records prevent harm to patients?

While digital records have improved the delivery of health care and introduced features—such as alerts about potential drug allergies—that can prevent medical errors and patient harm, they have also created unforeseen safety risks and contributed to serious mistakes in treatment.

What is electronic patient care report?

The National Ambulance Service (NAS) is introducing an electronic Patient Care Report (ePCR) to support patient care. This new technology will enable clinical audit practices in line with HIQA requirements and is part of the NAS National Programme for Information Technology.

What is ePRO in clinical trials?

What Is ePRO and How Is It Used In Clinical Trials? ePRO (short for electronic patient-reported outcomes) is a term that describes a category of clinical trials software which enables patients to digitally report their trial experience via their smartphone, tablet or computer, replacing the traditional approach of using paper forms.

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 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 is the purpose of patient-reported outcomes?

Patient-reported outcomes measures (PROMs) are a critical component of assessing whether clinicians are improving the health of patients.

What are patient-reported outcome measure?

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. In some cases, using pre- and post-event PROMs can help measure the impact of an intervention.

What are two types of patient reported outcome measures?

There are two basic types: General health PROMs can be used to survey patients with any condition. They usually focus on general well-being, mental health and/or quality of life. Condition-specific PROMs usually concentrate on the symptoms of a particular disease.

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 some of the advantages of using patient-reported outcomes?

The greatest perceived benefits were the ability to track changes in clinical symptoms over time, improved quality of care, and better disease control among patients, providers, and administrators, respectively.

What is an example of a patient reported outcome?

Health-Related Quality of Life Numerous generic health status measures, such as the Medical Outcomes Study Short Form SF-36 (and related measures) and the Sickness Impact Profile are classic examples.

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 PREMs and PROMs?

▪ Patient Reported Outcome Measures (PROMs) ▪ Real time patient feedback facilitated by Patient. Reported Experience Measures (PREMs)

What is electronic data collection?

Electronic data collection is the new norm for data collection in clinical settings, and is increasingly being used as a way to better track and manage patients outside the clinical setting. ePROs have so far been used most extensively in the context of clinical trials, but there is an inexorable move towards ePROS in other arenas. The U.S. Food and Drug Administration recently deployed an app-based data collection system called MyStudies to inform regulatory decision-making. ePROs are also a feature in Oncology Care First, the proposed follow-up to the CMS Oncology Care Model.

Why use epro?

Research has shown there are a number of issues with paper-based PROs, especially when individuals are unsupervised. Health journal Patient notes patients often provide untimely, unreadable, incomplete, or faulty data via paper-based approaches. For instance, an individual might back- or forward-fill diary entries in an effort to save time, skip over items on a questionnaire, or write answers illegibly. ePRO systems can help mitigate many of these issues, as they provide a more structured data-collection method. There are a number of benefits to using digital means to collect patient-reported data, including improved accuracy and compliance. With electronic data collection, the date and time of each entry is recorded, and patients cannot skip questions or provide out-of-range responses. Certain ePRO delivery systems can even provide alarms or reminders to patients if timely responses are imperative. These abilities often lead to more accurate, complete data.

Why is digital data important?

There are a number of benefits to using digital means to collect patient-reported data, including improved accuracy and compliance. With electronic data collection, the date and time of each entry is recorded, and patients cannot skip questions or provide out-of-range responses. Certain ePRO delivery systems can even provide alarms ...

Do all participants own a compatible device?

Not all participants may own a compatible device.

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.

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.

What are the benefits of PROs?

PROs can help assess symptoms, side effects of treatment, and quality-of-life outcomes. Many PROs measure outcomes that can only be assessed by the patient, like pain levels, nausea, or fatigue.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

See TrialStat In Action

Request Your Personalized Demo. Our Clinical Team will organize a tailored demonstration of TrialStat based on your specific study requirements. You'll see first hand how TrialStats unified features, blazing speed, configurable features and comprehensive functionality will help you run more efficient and cost effective studies.

What happens when questionnaires are divided into multiple forms?

If the questionnaires are divide into multiple forms the software automatically joins the forms sequentially giving the user a seamless experience without any complex navigation. In study designs that involve an interviewer collecting some of the data during the interviewing process, while other forms are meant for self completion, ...

Is epro better than paper?

ePRO offers a number of benefits compared to paper based data collection, including higher patient compliance compared to paper, better data quality and accuracy of study results, reduces missing data, data errors, and since the data can be entered in real-time at the time of an event, memory recall is reduced or eliminated. ePRO software also provides accurate data and time stamped information and allows investigator to review and monitor the self-completed data in real-times.

What is a PRO in health care?

Patient-reported outcomes (PROs) such as pain and other symptoms are commonly measured not only in research, but more commonly now in routine clinical care for symptom screening and to enhance communication, particularly those addressing chronic illnesses that impact patient quality of life and their activities of daily living. Use of PROs in performance evaluation is closely related to a growing interest in integrating PROs into electronic health records systems and patient portals [14]. Evidence demonstrates that patient reporting can improve communication, satisfaction, and symptom management [15,16]. There is evidence to support PRO in assessing baseline pain and changes in pain, analgesia, and analgesic-induced side effects in an effort to improve analgesia [17] ( Tables 6.1 and 6.2 ).

What is a PRO in SLE?

A patient-reported outcome (PRO) refers to an assessment of a patient’s health condition that comes directly from the individual (see Chapter 6 for further discussion). PROs are increasingly recognized as an important aspect of clinical practice and clinical trials. Many PRO instruments evaluate both global outcomes and specific quality-of-life domains. Examples of generic PRO instruments employed in SLE studies are the Short-Form 36 (SF-36) and EuroQol 5-dimension. Domains assessed by PRO tools include fatigue (e.g., Fatigue Severity Scale), pain (e.g., McGill Pain Scale), depression (e.g., Hospital Anxiety and Depression Scale), and work productivity (Work Productivity and Activity Impairment Questionnaire:Lupus). 33 There is also interest in using the Patient-Reported Outcome Measures Information System (PROMIS) instruments in SLE assessment. 34

How reliable is a PROM test?

The test should be reliable. The reliability should be evaluated by the test-retest reliability and measurement error. The test-retest reli ability assesses if the PROM provides similar answers on repeated measurements under the assumption that the symptoms and complaints are similar. Intraclass correlation coefficient (ICC) is commonly reported, and the reliability is considered to be good if the ICC is at least 0.70. Measurement error should be assessed to determine the agreement between repeated measurements in one patient. This is the systematic and random error of a patient’s score that is not attributed to true changes. 1,2

Why are proms important?

PROMs can be used for different purposes: as feedback for the patient self, for the clinician to identify which patient experiences improved or deteriorated health outcome over time, in clinical research, and as an indicator in healthcare systems for assessing the performance of hospitals and clinics.

What is the use of PROs?

Use of PROs is becoming standard practice for both randomized clinical trials and clinical care. The current shift in medicine toward patient-centered care is consistent with development and use of PROs.

What is a PRO in medicine?

This chapter reviews the definition, development, and utilization of PROs for both research and clinical purposes, including developmental considerations for administration of PROs with children. Health-related quality of life measures (HRQoL) are one type of PRO, and several condition-specific PROs have been developed for a variety of pediatric respiratory diseases, including vocal cord dysfunction, asthma, cystic fibrosis, sleep-related breathing disorders, and primary ciliary dyskinesia. A substantial body of literature has demonstrated that condition-specific, rather than generic measures, are more sensitive to change and better reflect the patient's symptoms and functioning. This chapter reviews the currently available PROs for pediatric respiratory conditions, including a description of the instrument, the domains of functioning it measures, the appropriate developmental age for administration, and the psychometric properties of the instrument, including its reliability and validity. Use of PROs is becoming standard practice for both randomized clinical trials and clinical care. The current shift in medicine toward patient-centered care is consistent with development and use of PROs. These measures provide unique information about patient symptoms, level of daily functioning, and systematic response to treatment. These measures have also been shown to facilitate patient-provider communication and shared decision-making. Integration of PROs into clinical care is a critical step in promoting patient-centered, quality health care practice.

What are some examples of SLE-specific PRO tools?

A variety of SLE-specific PRO tools have been developed to assess important SLE experiences that may be underemphasized or missed by generic tools, such as fatigue, pain, and emotional well-being. 33 Examples of lupus-specific instruments include the Lupus Quality of Life (LupusQoL) and the Lupus Patient-Reported Outcome (LupusPRO). In one study, LupusQoL was equivalent to the generic SF-36 for measuring quality of life over time. 35

Overview

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.