what is patient-report outcome (pros)

Patient-reported outcome From Wikipedia, the free encyclopedia 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.

Full Answer

What is Patient-Reported Outcome (PRO)?

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.

What are Patient Reported Outcomes in clinical trials?

Patient-reported outcomes (PROs) are instruments that evaluate daily functioning and health outcomes from the patient's perspective. If developed using standardized procedures (FDA Guidance, 2009), they can be used as primary or secondary outcomes in clinical trials evaluating new medications and treatments.

How can we minimize missing patient reports in PRO data?

Employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data Report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores, and Publish results of PRO analyses simultaneously with other clinical outcomes.

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].

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.

Why use patient-reported outcome measures?

The national Patient Reported Outcome Measures (PROMs) programme began in 2009. The purpose of PROMs is to collect information, from patients themselves, about how well the health service is treating them. PROMs allow us to understand the difference that healthcare interventions make to people's quality of life.

What is meant by patient-reported outcomes?

Information about a patient's health that comes directly from the patient. Examples of patient-reported outcomes include a patient's description of their symptoms, their satisfaction with care, and how a disease or treatment affects their physical, mental, emotional, spiritual, and social well-being.

Are patient-reported outcomes reliable?

Research shows a high correlation between patient-reported data and clinically documented chart abstracted data. This means data collected from patients is accurate and trustworthy.

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 is the difference between pro and prom?

PROs provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received. PROMs are tools and/or instruments used to report PROs.

What are PROs in clinical trials?

Patient-reported outcomes (PROs) are increasingly used in clinical trials to assess the impact of a medical treatment or intervention. PRO assess a range of outcomes including symptoms, functional health, well-being and psychological issues from the patients' perspective, without interpretation by a clinician [1,2,3].

How can patient-reported outcomes be improved?

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 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 ...

Why do outcome measures need to be reliable?

If you want to make decisions based on an outcome measure, you must be confident that, if no real change has occurred, your outcome measure will produce the same number each time you use it.

What is sufficient evidence for the reliability and validity of patient-reported outcome measures?

Several guidelines are recommended for establishing sufficient evidence of reliability and validity. For clinical trials, a minimum reliability threshold of 0.70 is recommended. Sample sizes for testing should include at least 200 cases and results should be replicated in at least one additional sample.

Why are proms important?

The use of PROMs continues to expand beyond clinical research in recognition of its potential to transform health care, as well as improve quality and safety by placing the patients at the center of decision-making.

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 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.

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 IRT model?

IRT is a probabilistic, mathematically based model used to describe the relationship between an individual’s response to questions about his or her health and an underlying variable measured by the instrument (eg, strength of attitude, intelligence).

What is a PRO in clinical practice?

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.

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 a PRO?

A PRO is any measure of a patient's health status that reflects how a person functions, feels, or survives, as reported by the patient himself or herself. 3 Health-related quality of life (HRQOL) measures are one type of PRO that typically includes several domains of functioning. 4 These tools capture the aspects of functioning known only to the patient, including his or her symptoms, behaviors, and daily functioning (e.g., frequency of cough, physical limitations, worries about the future). PROs can be used for several purposes: (1) as primary or secondary outcomes in clinical trials, (2) to evaluate pharmaceutical, surgical, or behavioral interventions, (3) to assess the effect of a disease on multiple aspects of patient functioning, and (4) to develop individualized treatment plans. 5–8

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.

Is condition specific measure more actionable than generic measure?

Although well-developed condition-specific or individualised measures are likely to have enhanced clinical relevance than generic measures, providing information that is more actionable, appropriate education and training in the application and interpretation of PROMs is required.

What is ASCQ ME?

ASCQ-Me is a HRQOL instrument for adults with sickle cell disease (SCD) that was developed under a National Institutes of Health (NIH)/ National Heart, Lung, and Blood Institute (NHLBI) initiative. It is designed to add specificity to the PROMIS HRQOL instrument in adults with SCD [29].

What is neuro-qol?

Neuro-QOL is a set of PRO measures that assesses the HRQOL of adults and children with neurological disorders such as stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson disease, epilepsy, and muscular dystrophy.

What is HRQOL in healthcare?

Health-related quality of life (HRQOL) is broadly defined as an individual’s or a group’s perceived mental and physical health over time. HRQOL includes the patient’s report of the way a disease or its treatment affects physical, emotional and social well-being [2].

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 the primary endpoint?

Primary endpoints are used to test treatment effect, calculate sample size, and are statistically and rigorously tested. Secondary endpoints are of clinical interest, and it is common to test secondary endpoints only after a treatment effect is shown for the primary endpoint [1].

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 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.

Analog vs. Digital

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.

Types of ePROs

There are three general collection categories for ePROs. Each type of ePRO has its merits, and a provider planning to incorporate ePROs should consider both the appropriateness of each collection method for their patient population and intended use, as well as whether more than one collection method should be used.

The Power ePROs

ePROs gather a whole range of measurements that cover a patient’s health status in terms of their physical and mental status as well as their social well-being. There is increasing recognition of the role that non-clinical factors, such as those that can be identified via ePROs, play in a patient’s overall health.

The Future of ePROs

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.

Why Are Patient-Reported Outcomes Important?

• When it comes to healthcare quality and outcomes, the patient voice informs the full picture, and fills in the “gaps” between care visits documented by their physician or specialists. PROs are the missing piece that complete the puzzle. There are parts of the story that only the patient (or a fa…

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How to Collect Patient-Reported Outcomes

Get Started with Pros

Defining Patient-Reported Outcomes

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National Institutes of Health

Interpreting Scores from Pro Instruments

Implementing Pro Measures

Future Directions For Pros