Understanding controlled trials: What outcomes should be measured?

BMJ 1998;317:1075-1080 ( 17 October )

Education and debate

Understanding controlled trials

What outcomes should be measured?

Martin Roland, director of research and development, ^a David Torgerson, senior research fellow. ^b

^a National Primary Care Research and Development Centre, University of Manchester, Manchester M13 6PL, ^b Centre for Health Economics, University of York, York YO1 5DD

Correspondence to Dr Roland
The first 150 words of the full text of this article appear below.

Many types of clinical, patient related, and economic outcomes can be measured in trials. The choice of one or more outcomeswill depend on the nature of the study and the question it istrying to answer. Objectives can relate to different levels ofobservation and analysis, from the individual to the family, thecommunity, and society as awhole.

If a trial is "explanatory"¹ then a single main measure of clinical outcome may be appropriate. For example, if a trialis designed to determine which of two antihypertensive agentsis more effective at lowering blood pressure then hypertensivecontrol will be the main outcome. Traditionally, clinical trialshave used physiological or biomedical outcomes, but these maynot be well related to clinical outcomes. One example of a surrogateoutcome measure which misled investigators was the CD4 count inAIDS trials: this turned out to be a poor predictor of . . . [Full text of this article]

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