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. A small pilot study is run to compare a new drug for chronic pain to one that

ID: 3048440 • Letter: #

Question

. A small pilot study is run to compare a new drug for chronic pain to one that is currently available. Participants are randomly assigned to receive either the new drug or the currently available drug and to report improvement in pain on a 5-point ordinal scale: 1 = Pain is much worse, 2 = Pain is slightly worse, 3 = No change, 4 = Pain improved slightly, 5 = Pain much improved. Use the appropriate test to assess whether there is a significant difference in self-reported improvement in pain, and report your test statistic.

New Drug:           4       5       3       3       4       2

Standard Drug:              2       3       4       1       2       3

        

Explanation / Answer

(A)

(B)

(C)

(D)

(E)

(F)

(G)

Pain Category

Frequency in New Drug

Frequency in Standard Drug

Proportion in New Drug

Proportion in Standard Drug

Combined Proportion

Z value

Worse

0

1

0

0.166667

0.083333

-1.04447

Slightly worse

1

2

0.166667

0.333333

0.25

-0.66667

No change

2

2

0.333333

0.333333

0.333333

0

Improved Slightly

2

1

0.333333

0.166667

0.25

0.666667

Much Improved

1

0

0.166667

0

0.083333

1.044466

In this example data is provided on 5-point ordinal scale. In the above table column A shows pain category, B shows frequency of patients in each category receiving new drug. Column C shows frequency of patients in each category receiving standard drug. Column D and E gives proportion of   patients in each category corresponding to the new and standard drug. Column F gives combined proportion of patients in each category. Lastly column F gives value of Z for testing equality of proportions in each category receiving new and standard drug. From values of Z it seems that all absolute values of Z are less than 1.64 and hence in each category the effect of both drugs is insignificant, it means drug is at par with standard drug

(A)

(B)

(C)

(D)

(E)

(F)

(G)

Pain Category

Frequency in New Drug

Frequency in Standard Drug

Proportion in New Drug

Proportion in Standard Drug

Combined Proportion

Z value

Worse

0

1

0

0.166667

0.083333

-1.04447

Slightly worse

1

2

0.166667

0.333333

0.25

-0.66667

No change

2

2

0.333333

0.333333

0.333333

0

Improved Slightly

2

1

0.333333

0.166667

0.25

0.666667

Much Improved

1

0

0.166667

0

0.083333

1.044466