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A Simplified Benefit-Risk Analysis of Testing

The above analysis is only a cost-benefit and not a benefit-risk analysis and therefore disregards the possible harm of unwarranted testing, which in fact does incur risk ( Fig. 25-4 ). Let us assume that the chest radiograph in the under-age-40 population has a sensitivity of 75% and a specificity of 95% (these values are better than the best in the literature for readings referenced by a single radiologist). Let us also assume that the prevalence of disease detectable by the test is 0.5%, that the benefit from true positives is 20 in 100 (better than the best in


Figure 25-4 Theory and actuality of what happens to well-being as testing increases. The straight line represents the common theory that "the more testing, the better"; that is, that well-being increases with testing. The A-to-E curve shows what actually happens as testing increases. At a certain point (point C), more harm than good may result. Therefore, point C represents the optimal point in the well-being versus testing relationship. The goal of using guidelines is to direct resources from point E to point C (to reduce testing and to increase well-being). Unless health-care providers allocate health resources in a cost-efficient manner, governmental restrictions will move testing from point C to point A—that is, will ration testing that improves well-being.


950

TABLE 25-11 -- Hypothetic benefit-risk analyses for two tests, under three circumstances
Test: Chest Radiograph Electrocardiogram
Patient: <40-Year-Old Asymptomatic Patient (%) 30-Year-Old-Asymptomatic Man, to Search for MI 47-Year-Old Asymptomatic Man, to Search for MI and Conduction Disturbance
Sensitivity of test 75 33%  50%
Specificity of test 95 90%  90%
Prevalence of disease detectable by test  0.5 ∼2.1% ∼15%
Benefit from true-positives 20 20%  20%
Harm rate for false-positives  6  6%   6%
Benefit per 1,000 patients


  Predicted true-positives  3.8  7  75
  Benefited patients  0.8  1.4  15
Harm per 1,000 patients


  Predicted false-positives  4.9 97.9  85
Harmed patients  3  5.9   5.1
Conclusion: Harm greater than benefit: do not test! Benefit greater than harm: test!
MI, myocardial infarction.

the literature)[110] [111] [112] [113] [114] [115] [116] [117] [118] [119] [120] [121] [122] [123] [124] [125] (see Table 25-6 ) (Apfelbaum JL et al, unpublished data), and that harm from false-positive results is 6 in 100 (see previous discussion)[82] [149] (Apfelbaum JL et al, unpublished data). For the asymptomatic under-age-40 population, the result would be harm to three individuals and benefit to only 0.8 individuals per 1,000 chest radiographs ( Table 25-11 ). Similar analyses are possible for other tests and situations (see Table 25-11 ).

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