Читать книгу Randomised Clinical Trials - David Machin - Страница 86

Two endpoints will be used to assess patient satisfaction:

1 Amongst patients who remain eligible: patient request to be moved to a ‘standard’ mattress because they are dissatisfied with the alternating pressure device.

2 The recording on discharge of whether or not (‘yes’ or ‘no’) patients experienced the following: excessive noise, interference with sleep, motion sickness, difficulty moving in bed, temperature, and overall comfort.

The primary endpoint for Protocol AHCC01 (1997) in patients with inoperable hepatocellular carcinoma was their survival time, which is unfortunately usually very short in such patients. Because of the multinational and multi‐lingual nature of this trial, assessing the secondary objectives with a quality of life instrument was not stipulated as mandatory for all participating centres.