Performance of combined clinical mammography and needle biopsy: a nationwide study from Denmark.

Clinical mammography and needle biopsy are key tools for non-operative assessment of breast lesions. We evaluated the performance of all combined tests undertaken in Denmark in 2000. Clinical mammography and needle biopsy data were collected and linked to final cancer outcome, to determine sensitivity, specificity, and predictive values of clinical mammography, needle biopsy, and combined test. In 2000, 6709 combined tests were performed in 36 mammography clinics in Denmark. The combined test was consistently more sensitive than any single test, increasing the proportion of women correctly identified with breast cancer by 9% compared with clinical mammography alone. For concordant combined tests (i.e. either both benign or both malignant), specificity and positive predictive value were 100%, sensitivity was 99.1%, and positive predictive value was 99.6%. Therefore, Danish patients with a malignant concordant combined test can proceed directly to definitive surgery without fear of a false-positive diagnosis, and Danish women with a concordant benign combined test can omit surgery without fear of a false-negative diagnosis. In discordant cases, our results showed that any of the two tests with a suspicious or malignant result indicated a high risk of cancer, and excisional diagnostic biopsy therefore still has an important role to play.

Performance of clinical mammography: a nationwide study from Denmark.

Clinical mammography is the key tool for breast cancer diagnosis, but little is known about the impact of the organisational set-up on the performance. We evaluated whether organisational factors influence the performance of clinical mammography. Clinical mammography data from all clinics in Denmark in the year 2000 were collected and linked to cancer outcome. Use of the National Institute of Radiation Hygiene register for identification of radiology clinics ensured comprehensive nationwide registration. We used the final mammographic assessment at the end of the imaging work-up to determine sensitivity, specificity and accuracy, the latter using a receiver-operating characteristics (ROC) analysis. In 96,534 clinical mammography examinations, sensitivity was 75% and specificity 99%. The presence of at least one high volume-reading radiologist in the clinic increased accuracy (AUC = 0.91 for <1,000 examinations/year and 0.92 for >2,000 examinations/year, p = 0.017). The examination volume per clinic showed no clear effect on performance, as accuracy was significantly higher in clinics with a medium number of examinations (AUC = 0.93 for 2,000-4,000 examinations/year and 0.90 for >6,000 examinations/year, p = 0.003). Accuracy was significantly lower in regions with high annual utilisation rate of clinical mammography, which means the proportion of examined women in a region (AUC = 0.90 for 3.0-5.0% annual utilisation rate and AUC = 0.93 for 2.0-2.5% annual utilisation rate, and p = 0.001), indicating that clinical mammography worked best in patient populations of purely symptomatic women. Our data indicate that to increase the accuracy of clinical mammography at the community level, the presence of an experienced radiologist should be prioritized ahead of raising the clinic size.

Mammography screening in the county of Fyn. November 1993-December 1999.

This report covers the outcome of the first three invitation rounds of the organised mammography screening programme in the county of Fyn. The programme started in November 1993, and the third invitation round ended on 31 December 1999. The screening takes place either at a special clinic located at University Hospital Odense or in a mobile unit. Women living in and around the city of Odense are examined at the clinic (about 55%), while the rest are examined in the mobile unit. Two-view mammography is used at the first screening. Women with dense breast tissue will continue to have two-view mammography (about 60%), whereas the rest will have singleview mammography at the subsequent screens. All screening images are exposed at the mammography-screening clinic and evaluated with double reading in the clinic. The programme targets women aged 50-69, except those undergoing treatment for breast cancer or going for regular check-ups following breast cancer. Based on the updated population register, the IT-Centre of the county of Fyn issues the invitations. Invited are all women aged 50-69 and living in the county of Fyn when their general practitioners' patients are invited. During the first 3 invitation rounds, 136,079 screening tests were made. Of these, 129,375 tests were made in the women aged 50-69 targeted by the programme. In addition, 6682 screening tests were made in women aged 70 and above, and 22 screening tests were made in women below the age of 50. As a consequence of the mammography screening 2657 assessments were made, 1145 women had surgery, 782 women were diagnosed with invasive breast cancer, and 109 women were diagnosed with ductal carcinoma in situ. A participation rate for the first invitation round was calculated immediately after the end of the round based on the number of participants divided by the number of women invited. This percentage was 88%. Invitation data are, however, not stored. It is therefore not possible now to calculate the participation rates in previous invitation rounds based on the same method. We have therefore chosen to calculate the participation rate as the coverage, i.e. the number of participants divided by the average number of women in the county of Fyn during a given invitation round. Calculated in this way, 84% participated in the first round, 84% in the second round, and 82% in the third round. It should be remembered that these figures do not take into account that some women are not invited because they 1) were undergoing current treatment for breast cancer or going for regular check-ups following breast cancer, or 2) did not participate in the previous round (and never actively informed the programme that they wanted an invitation to the next invitation round), relevant only for the second and third invitation round. For the second and third invitation rounds, the programme only invited women who participated in the previous invitation round, asked the clinic for an invitation, or entered the target population since the last invitation round. Therefore the participation rate in the second invitation round among actually invited women will be close to 94%, as 94% of those participating in the first round came for the second round. For the third invitation round, the participation rate among actually invited women will be close to 96%, as 96% of those participating in the first and second rounds came for the third round. One per cent of the participants in the first invitation round were diagnosed with invasive breast cancer or ductal carcinoma in situ. The detection rate was 0.5% in both the second and third invitation rounds. Ductal carcinoma in situ cases constituted 14% of the detected cases in the first and second rounds, and 10% in the third round. The percentage of invasive breast cancer 10 mm of less was 38%, 31%, and 32%, respectively, and 68%, 74%, and 73%, respectively, were node-negative. The screening programme of the county of Fyn fulfilled all the quality assessment parameters specified by the European guidelines on breast cancer screening, except two. The proportionate interval cancer rate was higher than specified in the guidelines, probably mainly due to the fact that the Fyn programme operates without early recalls. The proportion of stage II+ cancers was higher than specified in the guidelines, which seems, however, to be due to inconsistency between some of the performance indicators in the European guidelines. This analysis of the outcome from the first three invitation rounds of the mammography screening programme in the county of Fyn thus showed that it is a programme of high quality with a favourable profile of the prognostic indicators. The screening programme is hopefully well on its way to reducing breast cancer mortality in the county of Fyn.