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