Secondary outcomes are
additional outcomes monitored to help interpret the results of the primary outcome
: in our example, an increase in the 6MWD is inversely associated with the need for lung transplantation. They can also provide preliminary data for a larger study.
How do you identify primary and secondary outcomes?
In an experimental, quasi-experimental, or analytic observational research study, the primary study outcomes
arise from and align directly with the primary study aim or objective
. Likewise, any secondary study outcomes arise from and directly align with any secondary study aim or objective.
What are secondary outcomes of a study?
Secondary Outcome Measure: defined by ClinicalTrials.gov as “
an outcome measure that is of lesser importance than a primary outcome measure but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical study
and is not specified as an …
What is a secondary outcome variable?
secondary outcome
measures
The outcome measures in a clinical trial that provide information on therapeutic effects of secondary importance, side effects or tolerability
. Data on secondary outcomes are used to evaluate additional effects of the intervention not included in the primary outcome measure.
What is a primary outcome example?
Examples of primary outcome include [difference in… or difference in change in…]
blood pressure, recurrence of kidney stones, quality of life, pain score, death or albuminuria
. The ideal primary outcome is important to all stakeholders – especially to patients.
What is difference between primary and secondary endpoint?
The primary endpoint of a clinical trial is the endpoint for which the trial is powered. Secondary endpoints are
additional endpoints
, preferably also pre-specified, for which the trial may not be powered.
What is primary and secondary endpoint?
Clinical trial endpoints can be classified as primary or secondary.
The primary endpoint is the most important outcome
and is used to assess the primary objective of a trial.
What is an example of an outcome measure?
Outcome measures reflect the impact of the health care service or intervention on the health status of patients. For example:
The percentage of patients who died as a result of surgery
(surgical mortality rates). The rate of surgical complications or hospital-acquired infections.
Can you have more than one primary outcome?
Some trials may have more than one
primary outcome. Having several primary outcomes, however, incurs the problems of interpretation associated with multiplicity of analyses (see items 18 and 20) and is not recommended. Primary outcomes should be explicitly indicated as such in the report of an RCT.
What is a tertiary outcome?
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.
What is a secondary variable?
Secondary variables are either
supportive measurements related to the primary objective or measurements of effects related to the secondary objectives
.
What is a primary outcome vs secondary outcome?
The primary outcome is
the outcome of greatest importance
. Data on secondary outcomes are used to evaluate additional effects of the intervention.
Why is it important to identify a primary outcome?
There are 2 reasons for this: it
reduces the risk of false-positive errors resulting from the statistical testing of many outcomes
, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study.
What are the types of outcomes?
The three types of outcomes are
Organizational outcomes, Team outcomes, and Personal or Individual outcomes
.
Are primary endpoints the same as primary outcomes?
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).
How do you write a study outcome?
- Begin with an Action Verb. Begin with an action verb that denotes the level of learning expected. …
- Follow with a Statement. Statement – The statement should describe the knowledge and abilities to be demonstrated.
