Author, Year (ref) | Study design, Study period,Population, Readers | Index test (I) | Reference test | Results CI= confidence interval Se= sensitivity Sp=specificity | Study quality, Comments |
---|---|---|---|---|---|
Gilbert et al., 2008 [71] | Prospective, multicentre 2006-2007 | I.1: single reading + CAD, n=28,204 | Biopsy of suspected cases or follow-up (not all, though; number not reported) | Cancer detection rate: | Moderate |
 |  |  |  | Single reading + CAD: 7.02 /1000. |  |
 | Population: |  |  | Double reading: 7.06/1000. | Restricted generalisability since results were based on single reading +CAD by experienced radiologists. |
 |  |  |  | Difference not statistically significant (NS). |  |
 |  | I.2: double reading, n=28,204. |  |  |  |
 | Initially invited: 68,060 women. |  |  |  |  |
 |  |  |  | Recall rate: | Incomplete follow-up, particularly affecting the estimates of sensitivity. |
 | Investigated: 28,204. |  |  |  |  |
 | Aged 50-70 years (1 % > 70 years). |  |  | Single reading + CAD: 3.9 %. |  |
 |  |  |  | Double reading: 3.4 %. | Scanned analogue mammograms. |
 |  |  |  | Difference 0.5 % (95 % CI: 0.3;0.8). |  |
 | Readers: radiologists (n=17), specially trained staff (n=10). |  |  |  |  |
 |  |  |  | Accuracy: |  |
 |  |  |  | Single reading + CAD: |  |
 |  |  |  | Se= 87.2 % |  |
 |  |  |  | Sp= 96.9 % |  |
 | All readers had at least 6 years’ experience and >5000 readings/year |  |  | Double reading: |  |
 |  |  |  | Se= 87.7 % |  |
 |  |  |  | Sp= 97.4 % |  |
 |  |  |  | Difference in sensitivity: |  |
 |  |  |  | 0.5 % (95 % CI: |  |
 |  |  |  | -7.4;6.6), (NS). |  |
 |  |  |  | Difference in specificity 0,5% ( CI not specified but reported NS). |  |
Gromet et al., 2008 [69] | Retrospective | I.1: Single reading + CAD | Biopsy and follow-up | Cancer detection rate: | Low |
 | Population: |  |  | Single reading + CAD: 4.2/1000. | Retrospective study (controlled for age and time since last screening). |
 | 231 221 women |  |  | Double reading: 4.46/1000 (NS). |  |
 | 2001-05 | n=118,808. |  |  |  |
 |  | I.2: Double reading |  |  | Follow-up time unclear. |
 | Readers: |  |  |  |  |
 |  |  |  |  | Screening situation not applicable to European conditions (i.e. recall rate higher than accepted in Europe). |
 | Single reading + CAD: specialists in mammography. |  |  |  |  |
 |  | n=112,413. |  | Recall rate: |  |
 |  |  |  | Single reading + CAD: 10.6 %. |  |
 | Double reading: Specialists in mammography + radiology. |  |  | Double reading:11.9%. |  |
 |  |  |  | Difference statistically significant (p=0.001). |  |
 |  |  |  |  | Invitation procedure and blinded readings unclear. |
 |  |  |  | Accuracy: |  |
 |  |  |  | Single reading + CAD: Se= 90.4 % | Scanned analogue mammograms. |
 |  |  |  | Double reading: |  |
 |  |  |  | Se=88.0 %. |  |
 |  |  |  | Difference statistically significant. |  |
 |  |  |  | Percent of recalled with cancer: |  |
 |  |  |  | Single reading + CAD: 3.9%. |  |
 |  |  |  | Double reading: 3.7% (NS). |  |
Georgian-Smith et al., 2007 [68] | Prospective | I.1: Single reading + CAD | Biopsy and at least 12 months´ follow-up to detect false negatives. | Cancer detection rate: | Low |
 | Study period: 2001-03 |  |  | Single reading +CAD: 2.0/1000. | Screening situation not applicable to European conditions. Invitation procedure not described. |
 |  | n=6381. |  | Double reading: 2.4/1000 (NS). |  |
 | Population: 6381 consecutive screening examinations |  |  |  |  |
 |  | I.2: Double reading |  |  |  |
 |  |  |  | Recall rate: | Population, selection criteria, withdrawals unclear. |
 |  | n=6381. |  | Single reading +CAD: 7.87%. |  |
 |  |  |  | Double reading: 7.93% (NS). |  |
 | Readers: |  |  |  | Not independent double reading but blinded to CAD |
 | Experienced breast radiologists |  |  | Accuracy: |  |
 |  |  |  | Sensitivity and specificity not reported. | Number of recalls based on all readings. |
 | Single reading + CAD. |  |  |  | Scanned analogue radiographs. |
 | Double reading: Not independent reading. |  |  |  |  |
Khoo et al., 2005 [70] | Prospective | I.1: Single reading +CAD n= 6111. | Biopsy | Cancer detection rate: | Low |
 | Study period: not reported. |  | Not reported | Total for double reading + single reading + symptomatic patients:10/1000. | A so-called relative sensitivity used since 3-year follow-up not yet achieved. |
 |  |  | No follow-up |  |  |
 | Population: 6,111 women (45-94 years), screening every 3rd year |  |  |  |  |
 |  |  |  | Not reported individually for the groups. |  |
 |  |  |  |  | Relatively high screening age and long screening intervals. |
 |  | I.2: Double reading n= 6111. |  |  |  |
 |  |  |  | Recall rate: |  |
 |  |  |  | Single reading + CAD: 6.1%. | Unclear whether the readings were blinded. |
 |  |  |  | Double reading: 5.0 %. | Incomplete follow-up. |
 | Readers: |  |  | Difference statistically significant | Scanned analogue radiographs. |
 | Radiologists (n=7) and specially trained staff (n=5). |  |  |  |  |
 |  |  |  | Accuracy: (relative sensitivity)* |  |
 |  |  |  | Single reading + CAD: Se= 91.5%. |  |
 |  |  |  | Double reading: Se= 98.4% (NS). |  |
 | Double reading not always performed by two radiologists. |  |  |  |  |