This survey is intended for clinical trialists, clinicians who routinely read articles about clinical trials,  and for statisticians and epidemiologists who work in clinical trials.  The goal is to ascertain current opinions about how a simple endpoint (here, stroke) should be reported when the endpoint may be interrupted by another endpoint (here, all-cause mortality).

Suppose that in a high risk patient population a new treatment is intended to reduce the risk of stroke within 30 days of a certain intervention.  Treatments are labeled A and B and 100 patients are randomized to each treatment.  Stroke may be interrupted by all-cause death, and death may also occur at or after a stroke.  So the count of the number of strokes is the number of patients having a stroke before or at the moment of death.

Suppose the trial results in the following event frequencies:

                                A     B
a  Nontatal stroke             12    16
b  Fatal stroke                 1     1
c  Stroke (fatal or nonfatal)  13    17    a+b
d  Death without stroke         5     1
e  Death after nonfatal stroke  1     2
f  Death                        7     4    b+d+e
g  Stroke or death             19    20    a+f=c+d+e

                                A     B
a  Stroke, alive               11    15
b  Stroke, fatal                1     1
c  Stroke, later death          1     1
d  Death, no stroke             5     1
e  Stroke                      13    17    a+b+c
f  Death                        7     3    b+c+d
g  Stroke or death             18    18    a+b+c+d

1.  Which of a-g should be emphasized when the trial is reported (which also dictates the primary statistical analysis)?

2. If you were to select a category that includes both strokes and deaths, which analytical approach do you favor?

a. A traditional comparison of two proportions where death and stroke are considered equally bad
b. An ordinal analysis where death is counted as worse than a nonfatal stroke, without assuming how much worse



3. Please select the category that best describes you

a. clinical trialist
b. clinician not engaged in clinical trial design
c. statistician
d. epidemiologist
e. other


4. Please provide any comments you care to make about how the above endpoints should be analyzed or interpreted