conference patient report outcome

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.

What is a Patient-Reported Outcome (PRO)?

A patient-reported outcome (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” (FDA 2009).

How do you measure patient-reported outcomes and experiences?

Patient-reported outcomes and experiences are commonly collected using questionnaires. Use existing standardised measures if they already exist. For example, there is a current national PROMs programme in England which measures PROMs before and after 4 inpatient procedures.

Are Patient-Reported Outcomes of a clinical intervention important?

The outcomes of a clinical intervention obtained by the patient i.e. patient-reported outcomes (PROs) are seemed to be of more importance in future than any other outcomes like clinical, physiological or caregiver-reported.

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 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 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 patient-reported outcomes in clinical trials?

Patient-reported outcomes (PROs) are any report of the patients' perspectives about the impact of disease and treatment on their health status, for example quality of life and symptoms, without the interpretation of a clinician, or anyone else [1, 2].

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 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 PREMs and PROMs?

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

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. ...

Why patient reported outcomes are important?

Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention.

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.

How do you include patient reported outcome measures in clinical trials?

How to Collect Patient-Reported Outcomes in Clinical TrialsStep 1: Research existing PRO instruments for your condition area. ... Step 2: Conduct patient interviews or focus groups. ... Step 3: Decide whether you'll use electronic patient-reported outcomes or paper forms. ... Step 4: Formulate your questions and timing.More items...•

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.

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.

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.

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 a PRO in medical terms?

A patient-reported outcome (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” (FDA 2009).

Why are PROs important?

PROs provide crucial information for patients and clinicians facing choices in health care. Conducting systematic reviews and meta-analyses including PROMs and interpreting their results is not straightforward, and guidance can help review authors address the challenges.

Can a PRO be used in different studies?

The definition of a particular PRO may vary between studies, and this may justify use of different instruments (i.e. different PROMs). Even if the definitions are similar (or if, as happens more commonly, the investigators do not define the PRO), the investigators may choose different instruments to measure the PROs, especially if there is a lack of consensus on which instrument to use (Prinsen et al 2016).

Why do patients track their outcomes between office visits?

Because patients track their outcomes between office visits and can communicate electronically when there is a change, the timing of appointments (urgent care for flare-up or routine follow-up) and their duration and content can be preplanned by the office staff and guided by patients’ needs and priorities.

What happens outside of the clinical encounter?

For most patients there is no systematic or effective method for communicating what happens outside the clinical encounter, such as perceived needs, symptoms, response to treatment, undesirable side effects, effect on function, and what matters to patients and their families.

How does HowsYourHealth work?

Developed in 1994 and disseminated on the internet since 1999 without charge to primary care practices, the HowsYourHealth system provides an immediate and standard source of information about patients’ function, diagnosis, symptoms, health habits, preventive needs, capacity to self manage chronic conditions, and their experiences of care. 16 Patients enter all the data themselves, mainly using tick boxes in response to questions. For practice improvement the system also provides a summary of all patient data (with national benchmarks) and a secure registry to target interventions at groups of patients with similar needs (such as those with diabetes, emotional problems, or low confidence to self manage health problems). The system is used by hundreds of practices in the United States and Canada, and initiatives to increase uptake are under way in Iowa, Massachusetts, and British Columbia. The system is endorsed by several medical specialty organisations.

How does a prom system help?

PROM systems have the potential to enable improvement by providing information that can bridge the gap between the clinical reality and the patient world, triggering learning as well as the right next action. PROM systems must be codeveloped by patients, the public, and professionals to obtain maximum value.

What is the purpose of evaluating the effectiveness and experience of care using patient-reported outcomes?

It has been widely used in randomised controlled trials assessing the effect of new medications or medical procedures.

How to develop high quality outcome measures?

Developing high-quality outcome measures takes time and involves making sure that that the outcome: measures what it is supposed to measure (validity) measures it consistently in different circumstances (reliability) You should develop the measures in collaboration with patients and experts in the relevant health area.

Why is it important to use a disease specific questionnaire?

questionnaires can be burdensome for patients to complete, so it is important to balance between the need to show impact and burden. you should use disease-specific measures if you are assessing the impact of your intervention on a particular health condition, but disease-specific measures don’t always exist.

What is coach facilitated web based therapy?

MacLean and others (2020), ‘ Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial ’. The team assessed the effects of online therapy on depression in a trial.

1 Introduction to Patient-Reported Outcomes#Section-18-1

• 18.1.1 What are patient-reported outcomes?#section-18-1-1
  A patient-reported outcome(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” (FDA 2009). PROs are one of several clinical outcome assessment methods that c…
• 18.1.2 Why patient-reported outcomes?#section-18-1-2
  PROs provide patients’ perspectives regarding treatment benefit and harm, directly measure treatment benefit and harm beyond survival, major morbid events and biomarkers, and are often the outcomes of most importance to patients and families. Self-reported outcomes often correl…

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2 Formulation of The Review#Section-18-2

3 Appraisal of Evidence#Section-18-3

4 Synthesis and Interpretation of Evidence#Section-18-4

5 Chapter Information#Section-18-5

6 References#Section-18-6