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  1. 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.

  2. The great majority of trials (89% in our survey) predefined a single primary outcome. Obviously, the choice of primary outcome is crucial, balancing clinical and statistical issues: the measure(s) that best capture the overall efficacy of a treatment that can be adequately powered for a realistic treatment benefit.

  3. 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.

  4. 10 Απρ 2023 · The primary outcome of medical research is the main outcome measure that the study aims to answer (i.e. based on the primary objective). In an experimental, semi-experimental or observational research study, the primary study outcome is based on and aligned directly with the primary objective.

  5. In this chapter, we provide an overview of types of outcomes (with emphasis on those most relevant to observational CER studies); considerations in defining outcomes; the process of outcome ascertainment, measurement and validation; design and analysis considerations; and means to evaluate and address bias that may arise. Go to:

  6. 19 Νοε 2020 · Learn about the clinical, practical, and statistical considerations in choosing outcomes for clinical trials, with a focus on the primary outcome. Find out the definitions, types, and examples of outcomes, and how to evaluate their quality and multiple outcomes.

  7. Primary outcome: The planned outcome that is most directly related to the primary objective of the trial. 5 It is typically the outcome used in the sample size calculation for trials with the primary objective of assessing efficacy or effectiveness. 31 Many trials have 1 primary outcome, but some have >1.

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