Table 2.
Methodological difficulties and factors decreasing apparent rupture risks in ISUIA.
1. Poorly defined objectives and indeterminate hypotheses | |
2. Irrelevant population of patients excluded from treatment | |
3. Selection bias at entry manifest by: | a. age |
(all p <.001 as compared to treated cohorts) | b. Size of lesion |
c. History of hemorrhage from another lesion | |
d. Location | |
e. Multiplicity | |
f. Symptoms | |
4. Undefined observation period | |
5. Error rates and sample size not pre-specified | |
6. Excessive losses to follow-up (21% of patients | a. Excessive loss by unrelated (?) |
followed at 4 years) | mortality (12.7%) |
b. Excessive loss by cross-over | |
(32% eventually treated; reasons?) | |
7. Assessment of outcome events was not blind | |
8. Exclusion of events when other potential causes for intracranial bleeding (n=31) | |
9. Exclusion of other intracranial hemorrhagic deaths (n= 19) | |
10. Exclusion of deaths of unknown cause (n= 11) | |
11. Post-hoc definition of subgroups | |
12. Arbitrary relocation of P. Com aneurysms | |
13. Inclusion of extradural lesions (cavernous lesions) | |
14. Systematic attribution to large or posterior location categories when lesions multiple (40%) | |
15. Incomplete reporting: | a. Actual numbers not provided |
b. Confidence intervals not provided | |
c. Methodological obscurities |