Patient-Reported Outcome - an overview | ScienceDirect …
5 hours ago [a] PRO is 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. The outcome can be measured in absolute terms (e.g., severity of a symptom, sign, or state of a disease) or as a change from a previous measure. >> Go To The Portal
Patient-reported outcomes encompass a wide range of measurable outcomes of care from the patient’s perspective, including symptoms, functional status, and health-related quality of life (HRQoL) [ 1 ]. A PRO is directly reported by the patient without the interpretation of the patient’s response by a clinician or anyone else [ 2 ].
Full Answer
How do you define a patient reported outcome?
Defining Patient-Reported Outcomes. [Back to top] 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].”.
What are the characteristics of Patient-Reported Outcomes?
Patient-reported outcomes typically include information about health-related quality of life (HRQOL), symptoms, function, satisfaction with care or symptoms, adherence to prescribed medications or other therapy, and perceived value of treatment [2].
What is a patient-centered outcome?
The Patient-Centered Outcomes Research Institute (PCORI) recommends that the outcomes measured should include ones that patients notice and care about (e.g., survival, function, symptoms, health-related quality of life) [5]. If a PRO is used as a primary or secondary endpoint, it must be clearly defined and specified in the research protocol [1].
How do patients report experiences through Prems?
Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety.
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 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 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 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 patient health outcomes?
Health outcomes measure a change in the health status of an individual or a group which can be attributed to intervention. Utilising health outcomes of care will determine the impact of the process of care or intervention on the patient's life by using specific measures before and after treatment.
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 are health outcome indicators?
Population health outcome indicators measure the effect of health care on health status at a population level i.e. it is aggregated data.
Why do we measure health outcomes?
Measuring health outcomes allows us to make decisions about how to best care for our patients and outcome measures help us predict the patients who might benefit most from a particular intervention. It helps us identify any improvement after an intervention is provided.
What are the outcomes of disease?
The prognosis is a prediction of the course of a disease following its onset. It refers to the possible outcomes of a disease (e.g. death, chance of recovery, recurrence) and the frequency with which these outcomes can be expected to occur.
Why patient-reported outcomes are important?
Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention.
What is a patient report experience?
Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety.
What is indicator in healthcare?
Indicators are a type of metric that identifies issues requiring further investigation (eg, increase in number of falls) (NHS Institute for Innovation and Improvement/Public Health Observatories, 2007) and reflects how effectively an organization is performing on a set of metrics.
What is a disease specific prom?
In contrast, disease-specific PROMs are designed to identify specific symptoms and their impact on the function of those specific conditions. Disease-specific PROMs have greater face validity and credibility than generic PROMs, but these comparisons cannot always be made across a variety of conditions.
Why is recording the reporter of the information important?
For this reason, recording the reporter of the information can be an important facet of a PRO dataset. PRO data are used to inform and guide patient-centered care as well as clinical and health policy decision-making.
What is a traditional method of measuring a health domain?
A traditional method of measuring a health domain uses a static questionnaire in which the number and order of the items are set. These instruments are intended to be used in their original validated forms; thus, altering or shortening the instrument would render it invalid. Some of the problems encountered with traditional questionnaires include excessive length, likelihood that data would be missing from completed questionnaires, and difficulties in comparing the results of different questionnaires that evaluated similar concepts.
What is the EGD for pro measures?
The Effectiveness Guidance Document (EGD) for incorporating PROs into comparative effectiveness research in adult oncology encourages the assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies [11]. Although PRO measures were originally designed to support clinical research, they are being used in clinical practice as well. The importance of direct patient reporting has been highlighted by both FDA and the European Medicines Agency (EMA) [12]. Because some of the effects of illness are known only to patients, FDA recommends that PRO outcomes instruments be used to assess efficacy outcomes in clinical trials [1]. The EMA is working to increase interaction with patient and consumer organizations (PCOs), and is revising their “Framework of Interaction” to incorporate the role of patients on scientific committees, their involvement in benefit/risk evaluation, and a strategy for training and support [13].
What is ICH in clinical trials?
The International Council on Harmonisation’s (ICH) Guidance for Industry on the Statistical Principles for Clinical Trials describes a set of best statistical practices that are broadly applicable to many clinical trials [34].
What is PRO data?
In addition, PRO data can be used to trigger patient education and interventions and as a means to triage patients to receive other services, helping the patient understand that the information they are reporting is meaningful to their care.
Why is it so difficult to link patient-reported outcomes to particular treatments?
Another major reason is that, generally, clinicians are not able to bill for time spent fielding outcomes surveys or interpreting such data. It's also difficult to link patient-reported outcomes to particular treatments since many factors—including patients' compliance and social factors—influence outcomes.
What is the Office of the National Coordinator for Health Information Technology?
The Department of Health and Human Services' Office of the National Coordinator for Health Information Technology also plans to incorporate PROMs into meaningful use standards, which is likely to prompt more widespread use.
What is a prom in clinical practice?
Use of PROMS in Clinical Practice. In the U.S., PROMs are in the early stages of development for use in clinical practice, as opposed to research. They have been most widely used to monitor conditions that rely on patients' reports (rather than diagnostic tests), such as depression or certain gastrointestinal disorders.
Defining Patient-Reported Outcomes
[Back to top] 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 .” Patient-reported outcomes typically inclu…
National Institutes of Health
- [Back to top] In 2004, a group of scientists from seven institutions and the NIH formed PROMIS, which was funded under the NIH Roadmap for Medical Research Initiative, now part of theNIHCommon Fund. In 2009 the Network was expanded to 12 institutions, three coordinating centers, and the NIH. PROMIS provides adult and pediatric item banks that measure health-relat…
Interpreting Scores from Pro Instruments
- [Back to top] The FDA’s PRO guidance provides recommendations for interpreting a change in PRO scores as evidence of treatment efficacy, and recommends establishing “responder definition” at the outset of a study.FDA defines responder definitionas “a score change in measure, experienced by an individual patient over a predetermined time period that has been d…
Implementing Pro Measures
- [Back to top] After a PRO and a device have been chosen; shown to be valid, reliable, and able to detect change ; and the goals for collecting PROs have been aligned, further work is needed to implement the PRO measure. First, the patients, setting, and timing of the assessments should be determined . Whenever possible, PRO data should be collected electronically and the proportion …
Future Directions For Pros
- [Back to top] Efforts are currently under way through the NIH Collaboratory to create guidelines and define best practices with respect to 1) selecting, compiling and curating the most appropriate PRO measures (and stimulating the development of new instruments when new solutions are needed); 2) providing guidance for the creation of efficient, high-quality PRO data c…
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