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Example 3.18 Protocol SQCP01 (2006): Comparing speech and growth outcomes between two different techniques and two different timings of surgery in the management of clefts of the secondary palate Method

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Infants will be recruited at age less than 12 months and followed up until 17 years of age. They will be assessed at age 18 months, 3, 5, 7, 9, 15 and 17 years.

The PRESSURE (2000) trial lists the sequences of assessments under different headings, and for each provides details of precisely what is required. We have indicated these headings in Example 3.19 but only for their section 8.2.3 have we specified the details. The number of assessments depends on whether or not the patient has, or subsequently develops, pressure sores and also on how long they remain in the hospital ward. As one would expect, this contrasts markedly with SQCP01 (2006) which stipulates seven assessment times scheduled at various growth and speech development stages of the children.

Randomised Clinical Trials

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