Читать книгу Randomised Clinical Trials - David Machin - Страница 89

This has been designed as a multi‐centre, randomised, controlled, open, fixed sample, parallel group trial with equal randomisation. Patients will be allocated an alternating pressure mattress overlay or an alternating pressure mattress replacement.

The main trial design will be supplemented with a qualitative study involving a purposive sample of 20–30 patients who develop pressure sores, in order to assess the impact of the pressure sores on their well‐being.

Here the design is clearly laid out as, for example, comparative and randomised and specifically refers to a ‘fixed sample’ as opposed to a ‘sequential’ (see Chapter 20) design. They also indicate a supporting study to assess the impact of pressure sores that may develop. It might have been easier for the reader of the protocol if acronyms were given for ‘alternating pressure mattress overlay’ and ‘alternating pressure mattress replacement’ as each have a common three‐word stem. Perhaps simply ‘Overlay’ and ‘Replacement’ with the capitals R and O could have been used.