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Example 1.1 Small parallel two‐group design – gastrointestinal function

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Lobo, Bostock, Neal, et al. (2002) describe a randomised trial in which 20 patients with colonic cancer either received postoperative intravenous fluids in accordance with current hospital standard practice (S) or according to a restricted intake regimen (R). A primary endpoint measure in each patient was the solid‐phase gastric emptying time on the fourth postoperative day. The observed difference between the median emptying times was shorter with R by 56 minutes with 95% confidence interval (CI) from 12 to 132 minutes. The trial also included preoperative and postoperative (days 0, 1, 3 and 5) measures of the concentrations of serum albumin, haemoglobin and blood urea in a repeated measures design.

Key features include the following:

 Design: Randomised comparison of a standard and test, single‐centre participation, unblinded assessment,

 Endpoint: Gastric emptying time,

 Size: 21 patients following colonic resection,

 Analysis: Mann–Whitney U‐test1 for comparing two medians,

 Conclusion: The restricted intake group had shorter delays in returning to gastrointestinal function.

1This can also be referred to as the Wilcoxon rank‐sum test.

Randomised Clinical Trials

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