fengmo4668
第2楼2012/10/11
Only 30 patients,can have 32 admissions? How?
poorlittle
第5楼2012/10/13
This may be a second study, the sample size may be 38 patients in the initial study. Or, the initial sample size was 38 patients in the planning stage, but the size of 40 patients was adopted as the designed (or determined) size in the study, therefore it may mean:
The sample size (20 patients for each group, totally 40 patients although the initial sample size consisted of 38 patients) was determined based on power calculations to detect inter-group differences in terms of clinical outcomes.
After the exclusion of 8 patients (20%) the two study groups each consisted of 16 randomised hospital admissions, giving a total of 32 admissions for 40 patients.
happyjyl
第6楼2012/10/27
一开始根据统计学要求计算出的样本量:每组20个患者,两组共40个。[1]
一开始实际入组的患者:38个。[2]
随机化后剔除了8个不符合临床试验方案要求的患者。[3]
理论上:方案要求受试者为住院患者[4]。一开始每组有20个随机的住院患者名额(admissions),两组共40个。试验开始后排除掉8个不符合方案要求的患者(占40个名额的20%),共还有32个名额,即每组16个。
实际上:一开始只入组了38个患者,排除掉8个不符合方案要求的患者,实际完成试验的只有30个。最后的试验数据和结论是在这30个患者的临床试验结果上统计分析后得出的。
[1] based on power calculations to detect inter-group differences in terms of clinical outcomes--临床结果应能检测出组间差异,并且该临床试验的把握度应符合要求。
[2]由于入组时限、患者数量等限制,有时不能在规定时间内入组足够数量的患者。
[3]见原文:The internal validity of the study results is questionable due to the small sample size and the fact that the analysis of the results was based on the principle of treatment completers, after the post-randomization exclusion of those patients who did not comply with the protocols.
[4]见原文:The study patients were set to be able to start TEN or TPN within 48 hours of hospital admission, without having any evidence of short bowel syndrome, Crohn's disease or major pancreatic resection.
fengmo4668
第7楼2012/10/27
多谢指点!
还是有个疑问,既然是30个病人,又怎么可以做出来32份数据报告呢?