Initial Entry Round (Year 1) Through Last Entry Round (Year 4) of Screening: False-Positive and Resulting Diagnostic Follow-Up Rates
| Physician Response | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Repeated Screening | Imaging | Minimally Invasive Procedurea | Moderately Invasive Procedureb | Major Surgical Procedurec | |||||||
| Subgroup | Ever False Positive No. (%) | No. (%)d | % of FPse | No. (%)d | % of FPse | No. (%)d | % of FPse | No. (%)d | % of FPse | No. (%)d | % of FPse |
| CA-125 = cancer antigen 125; CXR = chest radiograph; DRE = digital rectal examination; FP = false positive; FSG = flexible sigmoidoscopy; PSA = prostate-specific antigen; TVU=transvaginal ultrasonography. | |||||||||||
| Note: These percentages reflect only the subset of diagnostic procedures directly caused by a false-positive result; they do not include procedures associated with a true-positive or negative. | |||||||||||
| a Example: simple endoscopy with conscious sedation (see Table 1 for the complete list of procedure classifications). | |||||||||||
| b Example: tissue removal, more involved instrumentation, or general anesthesia, including laparoscopy. | |||||||||||
| c Example: prostatectomy, or laparotomy with colectomy or oophorectomy. | |||||||||||
| d Percentage among participants in the intervention arm that took at least 1 screening examination. | |||||||||||
| e Percentage among participants in the intervention arm that received at least 1 false-positive examination (change in denominator). This percentage (and the accompanying crude numbers) does not include procedures that resulted in a true positive (diagnosis of cancer). | |||||||||||
| f In each case, the denominator is the total number of participants taking examinations for a given screening modality; this number varied depending on differences in compliance with different tests. | |||||||||||
| Overall rates | 29,517 (43.1) | 13,576 (19.8) | 46.0 | 7,306 (10.7) | 24.8 | 2,049 (3.0) | 6.9 | 10,822 (15.8) | 36.7 | 1,062 (1.6) | 3.6 |
| Men | 17,432 (50.9) | 9,251 (27.0) | 53.1 | 4,056 (11.9) | 23.3 | 1,088 (3.2) | 6.2 | 6,972 (20.4) | 40.0 | 47 (0.1) | 0.3 |
| Women | 12,085 (35.3) | 4,325 (12.6) | 35.8 | 3,250 (9.5) | 26.9 | 961 (2.8) | 8.0 | 3,850 (11.3) | 31.9 | 1,015 (3.0) | 8.4 |
| By screening modality: menf | |||||||||||
| PSA | 3,388 (10.4) | 2,884 (8.9) | 85.1 | 1,494 (4.6) | 44.1 | 1 (0.0) | 0.0 | 1,491 (4.6) | 44.0 | 6 (0.0) | 0.2 |
| DRE | 4,882 (15.0) | 3,881 (12.0) | 79.5 | 1,326 (4.1) | 27.2 | 0 (0.0) | 0.0 | 1,259 (3.9) | 25.8 | 1 (0.0) | 0.0 |
| CXR | 6,320 (18.6) | 3,216 (9.5) | 50.9 | 1,466 (4.3) | 23.2 | 52 (0.2) | 0.8 | 77 (0.2) | 1.2 | 35 (0.1) | 0.6 |
| FSG | 8,186 (26.8) | 645 (2.1) | 7.9 | 157 (0.5) | 1.9 | 1,036 (3.4) | 12.7 | 4,821 (15.8) | 58.9 | 5 (0.0) | 0.1 |
| By screening modality: womenf | |||||||||||
| CA-125 | 888 (3.0) | 567 (1.9) | 63.9 | 349 (1.2) | 39.3 | 0 (0.0) | 0.0 | 103 (0.4) | 11.6 | 125 (0.4) | 14.1 |
| TVU | 2,310 (7.8) | 745 (2.5) | 32.3 | 1,394 (4.7) | 60.4 | 1 (0.0) | 0.0 | 677 (2.3) | 29.3 | 874 (3.0) | 37.8 |
| CXR | 5,531 (16.3) | 2,907 (8.6) | 52.6 | 1,498 (4.4) | 27.1 | 56 (0.2) | 1.0 | 93 (0.3) | 1.7 | 40 (0.1) | 0.7 |
| FSG | 5,239 (17.2) | 321 (1.1) | 6.1 | 151 (0.5) | 2.9 | 906 (3.0) | 17.3 | 3,072 (10.1) | 58.6 | 7 (0.0) | 0.1 |