Outcome measure

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.[1][2] Measures can often be quantified using effect sizes.[3] Outcomes measures can be patient-reported, or gathered through laboratory tests such as blood work, urine samples etc. or through medical examination.[1] Outcomes measures should be relevant to the target of the intervention (be it a single person or a target population).[2]

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).[1] 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.[1]

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.[1]

  1. ^ a b c d e Ross, David A.; Morrow, Richard H.; Smith, Peter G. (2015). Outcome measures and case definition. Oxford University Press. doi:10.1093/med/9780198732860.003.0012. ISBN 9780191797675.
  2. ^ a b Assessment of methods in health care - A handbook (PDF) (Preliminarily ed.). Swedish Agency for Health Technology Assessment and Assessment of Social Services. April 2018. pp. 18–19. Retrieved 2019-08-28.
  3. ^ Tripepi, G.; Jager, K.J.; Dekker, F.W.; Wanner, C.; Zoccali, C. (October 2007). "Measures of effect: Relative risks, odds ratios, risk difference, and 'number needed to treat'". Kidney International. 72 (7): 789–791. doi:10.1038/sj.ki.5002432. PMID 17653136.