A study was conducted to look for an association between the use of statins, wid

Question

A study was conducted to look for an association between the use of statins, widely-prescribed cholesterol lowering medications, and incidence of herpes zoster, a painful viral infection also known as “shingles” which is caused by reactivation of the virus from a previous case of chicken pox. Investigators in Taiwan examined data from 1,000,000 randomly selected enrollees in the National Health Insurance program. From these records, investigators were able to obtain records on 47,359 individuals age 18 or older who had a case of herpes zoster infection between January 2001 and December 2011. They then selected a comparison group of 142,077 participants who had no history of herpes zoster infection and were of the same gender and similar age as the herpes zoster cases in the year of their infection. The main results were summarized in terms of odds ratios and presented in Table 1 below.

Variable

Total (n=189,436)

Subjects with herpes zoster (n=47,359)

Controls (n=142,077)

n

%

N

%

n

%

Any Statin Use (regular or irregular)

24,523

13.0

7,315

15.5

17,208

12.1

     Crude OR (95% CI)

-

1.33*** (1.29,1.37)

1.00

     Adjusted OR (95% CI)

-

1.28***

1.00

If 95% Confidence interval for the difference between the proportion exposed in cases and controls is (0.049, 0.061), p-value = <0.0001

OR = 1.32, 95% CI for crude OR (1.28, 1.36)

1. A hypothetical reviewer of the manuscript of this paper might suggest that the results may be of statistical significance, but not clinical or practical significance. What do they mean by this distinction and why might that be a problem in this study?

2. As part of their criticism, the hypothetical reviewer points out that the proportion exposed in each group are merely a couple of percentage points apart. How does using the odds ratio rather than the proportion exposed help address this particular criticism?

Variable

Total (n=189,436)

Subjects with herpes zoster (n=47,359)

Controls (n=142,077)

n

%

N

%

n

%

Any Statin Use (regular or irregular)

24,523

13.0

7,315

15.5

17,208

12.1

     Crude OR (95% CI)

-

1.33*** (1.29,1.37)

1.00

     Adjusted OR (95% CI)

-

1.28***

1.00

Explanation / Answer

1. The data is not useful for the clinical purpose because it just uses the people of age 18 years or older..But for clinical purposes, we have to get it examined on people from each age group and with different abilities.

2. The odd Ratio is merely a ratio whose value is much more likely to be close for different issues.Thus even though the odd ratio looks similar, there may be a difference if we use the proportion

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