In a systematic review of the literature, we were able to demonstrate that the evidence is not sufficient to
recommend screening for bladder cancer in an asymptomatic population. Two trials of screening have
been performed that have also reported long-term outcomes. The two studies came to differing
conclusions on the mortality benefit of screening; furthermore, both studies suffered from a number of
significant flaws that prevent us from drawing conclusions. The body of evidence on the diagnostic
accuracy of tests used to diagnose primary bladder cancer is similarly weak. These studies contained
no single test has a high enough sensitivity and specificity to recommend its use in screening. Finally,
there is no evidence on whether earlier treatment of early stage bladder cancer is more beneficial than
later treatment, and we lack any data on the harms of screening. Without well-designed studies
addressing these important questions, we cannot appropriately balance the benefits and harms of a bladder
cancer screening program.
This study highlights the great need for well-conducted research on screening for bladder cancer.
A wide-spread, randomized controlled trial would be the highest level of evidence available. As such, we
recommend a wide-spread trial among older men, using hemoglobin dipstick, NMP22, or BTA stat as a
screening modality. It is critical that such a trial collects data on both the benefits and harms of screening,
so that a balanced evaluation of the screening program can be made. There is also a need for a
randomized trial comparing earlier versus later treatment of early stage bladder tumors. Finally, in the
absence of high-quality evidence on the effectiveness of screening, we believe that the most effective
public health intervention for the improvement of the substantial burden of bladder cancer may be
smoking cessation counseling.
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Appendix I
USPSTF-derived quality criteria for internal validity (28)
Design Criteria
Randomized controlled trials Initial assembly of comparable groups employs adequate randomization, including first concealment and whether potential confounders were distributed equally among groups.
Maintenance of comparable groups (includes attrition, crossovers, adherence, contamination)
Important differential loss to follow-up or overall high loss to follow-up
Measurements: equal, reliable, and valid (includes masking of outcome assessment) Clear definition of the interventions All important outcomes considered
Case-control studies Accurate ascertainment of cases
Nonbiased selection of cases/controls with exclusion criteria applied equally to both Response rate
Diagnostic testing procedures applied equally to each group
Measurement of exposure accurate and applied equally to each group
Appropriate attention to potential confounding variables
Cohort Studies Initial assembly of comparable groups employs consideration of potential confounders with either restriction or measurement for adjustment in the
analysis; consideration of inception cohorts Maintenance of comparable groups
(includes attrition, crossovers, adherence, contamination)
Important differential loss to follow-up or overall high loss to follow-up
Measurements: equal, reliable, and valid (includes masking of outcome assessment) Clear definition of the interventions All important outcomes considered