Consider the following hypothetical study: a study of 20 patients needed knee replacement surgery was conducted. Ten patients were randomized to have the surgery performed using the standard surgical...

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Consider the following hypothetical study: a study of 20 patients needed knee replacement surgery was conducted. Ten patients were randomized to have the surgery performed using the standard surgical anchors used for knee replacements and ten patients were randomized to have the surgery performed using a new surgical anchor.


The primary outcome for the study was the 6 month change in the Oxford Knee Score (a scale that can be scored between 0 and 48 - with low scores indicating bad outcomes for the knee and high scores indicating healthy outcomes for the knee).


The researchers found that the Oxford Knee Score improved by 9 units in the patients with the new anchor and 3 units with the standard of care anchor, but the p-value for the test of the difference was not statistically significant. In addition, the 95% confidence interval comparing the two groups for the difference in Oxford Knee Scores was 6 +/- 8 (i.e., confidence interval from -2 to +14).


The minimally clinically important change (difference) in a Oxford Knee Score is 5 units based on previous research.


Investigator one says that this study shows that the new anchor is better than the old anchor because the observed difference between groups is 6 units and that is larger than the minimally clinically significant difference of 5 units.


Investigator two says that this study has not shown that the new anchor is better than the old anchor because the p-value for the comparison is not significant and the confidence interval includes 0.


Investigator three says that this is an under-powered study and therefore we cannot tell if Investigator 1 or Investigator 2 is correct,


Based on your understanding of statistical power which Investigator 1, 2, or 3 is correct - Explain your reasoning.


What additional information might you request to better determine whether Investigator 3's claim concerning the study being under-powered is correct?

Answered 1 days AfterMar 24, 2021

Answer To: Consider the following hypothetical study: a study of 20 patients needed knee replacement surgery...

Vidya answered on Mar 26 2021
143 Votes
STATISTICAL STUDY
In the given hypothetical study, 20 patients who required a knee replacement surgery were considered. Out of these, 10 patients
were randomized for the surgery by using standard surgical anchors that are used for knee replacements and the rest of the 10 patients were randomized for the surgery by using a new surgical anchor. The six month change in the Oxford Knee Score was the primary outcome for the study. It is a scale which scores within the range of 0-48, which depicts bad outcomes for the knee by low scores and healthy outcomes for the knee through high scores. Though there was no statistically significant p-value for the test of the difference, an improvement of 9 units were seen among the patients who underwent surgery with new anchor and 3 units improvement with the standard surgical anchors. Also, the 95% confidence interval which compares the two groups for the difference in the provided Oxford Knee Scores was 6 +/- 8 that gives a confidence interval from -2 to +14. On a reference, based on previous research of the Oxford Knee Score, 5 units is the minimally clinically important difference or change.
From the above data, the study shows the efficiency of the new anchor when compared to the standard old anchors. This is depicted by the observed difference between the given groups which is more than the minimally clinically significant difference that is considered for the Oxford Knee Score i.e., 6 units which is...
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