What is a primary study outcome?

What is a primary study outcome?

The primary outcome is the variable that is the most relevant to answer the research question. Ideally, it should be patient-centered (i.e., an outcome that matters to patients, such as quality of life and survival).

What is primary outcome and secondary outcome?

Outcome (primary and secondary) – An outcome variable of interest in the trial (also called an end point). The primary outcome is the outcome of greatest importance. Data on secondary outcomes are used to evaluate additional effects of the intervention.

What is a primary outcome in an RCT?

Primary outcome (end point) is a very critical issue in the design of RCTs. A primary outcome is one which will be used to arrive at a decision on the overall result of the study. [4] Moreover, a primary outcome will also serve the basis to calculate the sample size for a particular RCT.

What is the main outcome of primary treatment?

Primary treatment removes material that will either float or readily settle out by gravity. It includes the physical processes of screening, comminution, grit removal, and sedimentation. Screens are made of long, closely spaced, narrow metal bars.

How do you identify primary outcomes?

Primary outcomes for the review should be identified from among the main outcomes. Primary outcomes are the outcomes that would be expected to be analysed should the review identify relevant studies, and conclusions about the effects of the interventions under review will be based largely on these outcomes.

How many primary outcomes can a study have?

Most clinical studies have one primary outcome measure, but a clinical study may have more than one”.

What is a secondary outcome?

Full explanation: Secondary outcomes are outcomes measured in studies or systematic reviews of treatment effects that are pre-specified in the protocol as being relevant, but less important than the primary outcomes.

Is primary outcome the same as primary endpoint?

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).

Can a study have 2 primary outcomes?

Multiple primary outcomes may be specified in a randomised controlled trial (RCT) when it is not possible to use a single outcome to fully characterise the effect of an intervention on a disease process [1,2,3]. The use of multiple primary outcomes (or ‘endpoints’) is becoming increasingly common in RCTs.

What is outcome in clinical research?

Outcomes (also called events or endpoints) are variables that are monitored during a study to document the impact that a given intervention or exposure has on the health of a given population. Typical examples of outcomes are cure, clinical worsening, and mortality.

How many primary outcomes should a study have?

There should in general be no more than three primary outcomes and they should include at least one desirable and at least one undesirable outcome (to assess beneficial and adverse effects respectively).

What is 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.

Which is the primary outcome of a study?

The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed.

Which is the most important outcome in a clinical trial?

The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study.

Why is the primary outcome measure so important?

The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-posit …

What happens if you include too many primary outcomes?

Including too many primary outcomes can (a) lead to an unfocused research question and study and (b) present problems with interpretation if the treatment effect differed across the outcomes. Inclusion of secondary variables in the study design and the resulting manuscript needs to be justified.