Clinical Outcome Assessment: Difference between revisions
No edit summary |
Kim Jackson (talk | contribs) m (Removed linked link and corrected editor code) |
||
| Line 1: | Line 1: | ||
<div class="editorbox"> | <div class="editorbox"> | ||
'''Original Editor '''- Adu Omotoyosi Johnson | '''Original Editor '''- [[User:Adu Omotoyosi Johnson|Adu Omotoyosi Johnson]] | ||
'''Top Contributors''' - {{Special:Contributors/{{FULLPAGENAME}}}} | '''Top Contributors''' - {{Special:Contributors/{{FULLPAGENAME}}}} | ||
</div> | </div> | ||
== Introduction == | == Introduction == | ||
A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include<ref>FDA [https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition COA] Available from:https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition (last accessed 14.5.2020)</ref>: | A clinical outcome assessment (COA) is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include<ref>FDA [https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition COA] Available from:https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition (last accessed 14.5.2020)</ref>: | ||
# Patient-reported outcome (PRO) measures | # Patient-reported outcome (PRO) measures | ||
# Observer-reported outcome (ObsRO) measures | # Observer-reported outcome (ObsRO) measures | ||
| Line 13: | Line 13: | ||
==Types of Clinical Outcome Assessments== | ==Types of Clinical Outcome Assessments== | ||
[[File:Scott-graham-OQMZwNd3ThU-unsplash.jpg|right|frameless]] | [[File:Scott-graham-OQMZwNd3ThU-unsplash.jpg|right|frameless]] | ||
=== Patient-Reported Outcomes (PRO) === | |||
* [[Outcome Measures|Outcome]] where the patient is the rater | * [[Outcome Measures|Outcome]] where the patient is the rater | ||
* Rely on a patient’s direct responses to questions | * Rely on a patient’s direct responses to questions | ||
* Responses may be recorded by the patient in a variety of ways such as on paper, via computerized questionnaire forms, or via interviews where the patient’s observations or reports are recorded exactly as spoken, without any interpretation (judgment) on the part of the interviewer. | * Responses may be recorded by the patient in a variety of ways such as on paper, via computerized questionnaire forms, or via interviews where the patient’s observations or reports are recorded exactly as spoken, without any interpretation (judgment) on the part of the interviewer. | ||
* Patient’s direct report can capture a wide range of feelings and functions, as well as provide a direct measurement of how a patient feels, e.g., pain or low mood | * Patient’s direct report can capture a wide range of feelings and functions, as well as provide a direct measurement of how a patient feels, e.g., pain or low mood | ||
Increasing interest in developing PRO COAs. FDA guidance on the topic <ref>US Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [Accessed July 20, 2014];2009 Available from :<nowiki>http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064981.htm</nowiki>.</ref> has highlighted the regulatory agency’s interest in these instruments<ref name=":0" /> | |||
=== Clinician-Reported Outcomes (ClinRo) === | |||
* Reflects the evaluation of a patient's condition by a healthcare professional | * Reflects the evaluation of a patient's condition by a healthcare professional | ||
* Based on the report that comes from a trained health care professional after observation of a patient's condition. a good example of this is the pain rating scale | * Based on the report that comes from a trained health care professional after observation of a patient's condition. a good example of this is the pain rating scale | ||
=== Observer-Reported Outcomes (ObsRo) === | |||
* Measurement based on an observation by someone other than the patient or a health professional. | * Measurement based on an observation by someone other than the patient or a health professional. | ||
* Usually done by patient's non-clinical care giver, family or anyone living around patient and observes the patient in daily life. A good example is the assessment of a patient's cognition. | * Usually done by patient's non-clinical care giver, family or anyone living around patient and observes the patient in daily life. A good example is the assessment of a patient's cognition. | ||
[[File:Trust-tru-katsande-A ftsTh53lM-unsplash.jpg|right|frameless]] | [[File:Trust-tru-katsande-A ftsTh53lM-unsplash.jpg|right|frameless]] | ||
=== Performance Outcome (PerfO) === | |||
* The patient is assessed, but no rater judgment impacts the measurement, categorized as COAs because a patient’s motivation or volition is involved in the task performance. | * The patient is assessed, but no rater judgment impacts the measurement, categorized as COAs because a patient’s motivation or volition is involved in the task performance. | ||
* Based on the patient’s performance of a defined task that is quantified in a specified way that does not rely on judgment to determine the rating. | * Based on the patient’s performance of a defined task that is quantified in a specified way that does not rely on judgment to determine the rating. | ||
* Include instruments such eg [[Six Minute Walk Test / 6 Minute Walk Test|distance walked in 6 minutes]] and [[Timed Up and Go Test (TUG)|Timed up and go]] | * Include instruments such eg [[Six Minute Walk Test / 6 Minute Walk Test|distance walked in 6 minutes]] and [[Timed Up and Go Test (TUG)|Timed up and go]] (TUG) | ||
* Clinician or observer is administering and monitoring performance of the PerfO assessment task, this individual does not apply judgment to quantifying the performance..<ref name=":0" /> | * Clinician or observer is administering and monitoring performance of the PerfO assessment task, this individual does not apply judgment to quantifying the performance..<ref name=":0" /> | ||
==The Context of Use of the COA== | ==The Context of Use of the COA== | ||
The context of use typically includes the following elements; | The context of use typically includes the following elements;[[File:Gabrielle-henderson-HJckKnwCXxQ-unsplash.jpg|right|frameless]] | ||
* Disease, injury, impairment or condition being treated | * Disease, injury, impairment or condition being treated | ||
* Patient population demographics (age, disease severity, | * Patient population demographics (age, disease severity, language, culture, education) | ||
* | *Clinical treatment objectives and plan of treatment | ||
== Conclusion == | == Conclusion == | ||
| Line 51: | Line 55: | ||
== References == | == References == | ||
<references | <references /> | ||
[[Category:Outcome Measures]] | [[Category:Outcome Measures]] | ||
Latest revision as of 14:19, 16 May 2020
Original Editor - Adu Omotoyosi Johnson
Top Contributors - Adu Omotoyosi Johnson, Kim Jackson and Lucinda hampton
Introduction[edit | edit source]
A clinical outcome assessment (COA) is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include[1]:
- Patient-reported outcome (PRO) measures
- Observer-reported outcome (ObsRO) measures
- Clinician-reported outcome (ClinRO) measures
- Performance outcome (PerfO) measures.[2]
Types of Clinical Outcome Assessments[edit | edit source]
Patient-Reported Outcomes (PRO)[edit | edit source]
- Outcome where the patient is the rater
- Rely on a patient’s direct responses to questions
- Responses may be recorded by the patient in a variety of ways such as on paper, via computerized questionnaire forms, or via interviews where the patient’s observations or reports are recorded exactly as spoken, without any interpretation (judgment) on the part of the interviewer.
- Patient’s direct report can capture a wide range of feelings and functions, as well as provide a direct measurement of how a patient feels, e.g., pain or low mood
Increasing interest in developing PRO COAs. FDA guidance on the topic [3] has highlighted the regulatory agency’s interest in these instruments[2]
Clinician-Reported Outcomes (ClinRo)[edit | edit source]
- Reflects the evaluation of a patient's condition by a healthcare professional
- Based on the report that comes from a trained health care professional after observation of a patient's condition. a good example of this is the pain rating scale
Observer-Reported Outcomes (ObsRo)[edit | edit source]
- Measurement based on an observation by someone other than the patient or a health professional.
- Usually done by patient's non-clinical care giver, family or anyone living around patient and observes the patient in daily life. A good example is the assessment of a patient's cognition.
Performance Outcome (PerfO)[edit | edit source]
- The patient is assessed, but no rater judgment impacts the measurement, categorized as COAs because a patient’s motivation or volition is involved in the task performance.
- Based on the patient’s performance of a defined task that is quantified in a specified way that does not rely on judgment to determine the rating.
- Include instruments such eg distance walked in 6 minutes and Timed up and go (TUG)
- Clinician or observer is administering and monitoring performance of the PerfO assessment task, this individual does not apply judgment to quantifying the performance..[2]
The Context of Use of the COA[edit | edit source]
The context of use typically includes the following elements;
- Disease, injury, impairment or condition being treated
- Patient population demographics (age, disease severity, language, culture, education)
- Clinical treatment objectives and plan of treatment
Conclusion[edit | edit source]
- An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient’s health status.
- Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition.
- Most efficacy endpoints are based on specified clinical assessments of patients.
- When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs).[2].
Resources[edit | edit source]
References[edit | edit source]
- ↑ FDA COA Available from:https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition (last accessed 14.5.2020)
- ↑ 2.0 2.1 2.2 2.3 Walton MK, Powers III JH, Hobart J, Patrick D, Marquis P, Vamvakas S, Isaac M, Molsen E, Cano S, Burke LB. Clinical outcome assessments: conceptual Foundation—Report of the ISPOR clinical outcomes assessment–emerging good practices for outcomes research Task force. Value in Health. 2015 Sep 1;18(6):741-52. Available from:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4610138/ (last accessed 14.5.2020)
- ↑ US Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [Accessed July 20, 2014];2009 Available from :http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064981.htm.
