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3.4.2 Outcome measures

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The eventual design chosen will have been influenced by the outcome measures, certainly by the primary one, and each endpoint measure must be explicitly defined. The trial structure in terms of, for example, the frequency and timing of the (possibly repeated) assessments should enable the endpoint for each individual subject on the trial to be determined. Thus, in the PRESSURE (2000) trial, in those patients admitted without pressure sores skin conditions were assessed daily by the ward nursing staff using the skin classification scale stipulated within the protocol.

Randomised Clinical Trials

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