Clinical Outcome Measure
An Clinical Outcome Measure is a physical measure that can be referenced as a clinical endpoint.
- Context:
- It can range from being a Primary Outcome Measure to being a Secondary Outcome Measure.
- It can range from being a Clinical Research Trial to being a Healthcare Delivery Endpoint.
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- Example(s):
- disease relapse.
- chest pain.
- tumor shrinkage.
- a Peak Volume of Oxygen.
- a PROMIS Fatigue Score.
- a Difficult to Assess Outcome Measure, such as: Suicide Attempt, Gout Flare, Silent Myocardial Infarction, to Early Miscarriage.
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- Counter-Example(s):
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- See: Surrogate Endpoint, Clinical Trial, Effect Size, Patient-Reported Outcome, Blood Test, Clinical Urine Tests, Physical Examination, Random Assignment, Clinical Endpoint.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/endpoint Retrieved:2021-12-15.
- Outcome measure, a measure used as an endpoint in research
- Clinical endpoint, in clinical research, a disease, symptom, or sign that constitutes one of the target outcomes of the trial or its participants
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Outcome_measure Retrieved:2021-12-15.
- An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. Measures can often be quantified using effect sizes. Outcomes measures can be patient-reported, or gathered through laboratory tests such as blood work, urine samples etc. or through medical examination. Outcomes measures should be relevant to the target of the intervention (be it a single person or a target population).
Depending on the design of a trial, outcome measures can be either primary outcomes, in which case the trial is designed around finding an adequate study size (through proper randomization and power calculation). Secondary or tertiary outcomes are outcome measures which are added after the design of the study is finalized, for example when data has already been collected. A study can have multiple primary outcome measures.
Outcome measures can be divided into clinical endpoints and surrogate endpoints where the former is directly related to what the goal of the intervention, and the latter are indirectly related.
- An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. Measures can often be quantified using effect sizes. Outcomes measures can be patient-reported, or gathered through laboratory tests such as blood work, urine samples etc. or through medical examination. Outcomes measures should be relevant to the target of the intervention (be it a single person or a target population).
2020
- https://clinicaltrials.gov/ct2/about-studies/glossary
- QUOTE: ... Outcome measure: For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure. ...
2020
- https://rethinkingclinicaltrials.org/chapters/design/choosing-specifying-end-points-outcomes/choosing-and-specifying-endpoints-and-outcomes-introduction/
- QUOTE: ... For an explanatory trial, investigators can specify any outcome or endpoint, define the endpoint, and then measure it. The term outcome usually refers to the measured variable (eg, peak volume of oxygen or PROMIS Fatigue score), whereas an endpoint refers to the analyzed parameter (eg, change from baseline at 6 weeks in mean PROMIS Fatigue score). Even after a specific outcome is selected, it may be challenging to determine the best way to measure the effect of an intervention in terms of an analyzable endpoint, especially with pragmatic research where data are collected as part of routine care.
With pragmatic research, the endpoints and outcomes need to be available as part of routine care. Although the research question regarding the relative risks, benefits, and burdens of a specific intervention or activity will drive the selection of endpoints and outcomes, in a PCT, the selection must be balanced with an understanding of what is available in the electronic health record (EHR) or claims data and what additional resources will be needed to capture information not found in these sources. ...
- Defining endpoints and outcomes for some health phenomena is relatively easy for things like
- acute myocardial infarction
- broken bone
- hospitalization
- However, many outcomes are not routinely recorded as part of healthcare delivery. For example:
- QUOTE: ... For an explanatory trial, investigators can specify any outcome or endpoint, define the endpoint, and then measure it. The term outcome usually refers to the measured variable (eg, peak volume of oxygen or PROMIS Fatigue score), whereas an endpoint refers to the analyzed parameter (eg, change from baseline at 6 weeks in mean PROMIS Fatigue score). Even after a specific outcome is selected, it may be challenging to determine the best way to measure the effect of an intervention in terms of an analyzable endpoint, especially with pragmatic research where data are collected as part of routine care.