Intended for healthcare professionals

Education And Debate Understanding controlled trials

What outcomes should be measured?

BMJ 1998; 317 doi: (Published 17 October 1998) Cite this as: BMJ 1998;317:1075
  1. Martin Roland, director of research and developmenta,
  2. David Torgerson, senior research fellowb
  1. aNational Primary Care Research and Development Centre, University of Manchester, Manchester M13 6PL
  2. bCentre for Health Economics, University of York,York YO1 5DD
  1. Correspondence to Dr Roland

    Many types of clinical, patient related, and economic outcomes can be measured in trials. The choice of one or more outcomes will depend on the nature of the study and the question it is trying to answer. Objectives can relate to different levels of observation and analysis,from the individual to the family, the community, and society as a whole.

    If a trial is “explanatory”1then a single main measure of clinical outcome may be appropriate. For example, if a trial is designed to determine which of two antihypertensive agents is more effective at lowering blood pressure then hypertensive control will be the main outcome. Traditionally, clinical trials have used physiological or biomedical outcomes, but these may not be well related …

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