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a randomised double blind control trial is conducte dto asses efficacy of a drug to prevent osteoporotic # in women more tahn 60 yrs of age.6o women are enrolled .30 of them are given drugX ( new drug) ....30 received placebo Y .2 yrs later 7 of group X had # and 15 of group Y had # .( p=0.06) .investigators concludde that there is no significant diff between the 2 drugs and the use of X is not recommended .which of the foll raises teh most concern about the validity of the conclusion?
a0 inappropriate study population
b0 low external validity
c0 low power
d) ose of blinding
e) use of placebo .
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i think the answer is a--->number of pts in study is very low,gl
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since the p value is more so the test is not statistically significant and so low external validity?
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I think the answer is c. ...i.e. low power.
As Mahshid has mentioned the major concern with the study design appears to be a arather low n(number of subjects recruited)
and since a low n results in low power...I would think the best possible response is c.
The study population chosen itself is appropriate as women at greatest risk alone have been chosen for random allocation to drug and placebo groups.
So I disagree with a being the correct answer.
Also I do not think that Validity of a study and the p value obtained do not have a direct relationship.
