This document was published more than 2 years ago. The nature of the evidence may have changed.
In Sweden, all women aged 50 through 69 years are offered mammography at regular intervals. Most county councils even offer this type of examination to women aged 40 through 49 years and 70 through 74 years. Swedish and European guidelines recommend that two specially trained radiologists (breast radiologists) review the breast images. Computer-aided detection (CAD) is a computerised method for analysing images from e.g. mammography screening. Although the method has existed for approximately 10 years, its clinical use in Sweden is limited.
The method under investigation is computer-aided detection (CAD) in breast cancer screening. The target group includes women aged 40 through 74 years who receive mammography within the framework of population-based screening.
The program used in CAD identifies and marks areas that the software identifies as abnormal breast tissue. The CAD program is not intended as the only method to be used when analysing mammography images. Rather, it is designed to alert the radiologist about possibly suspicious areas. Hence, interpretation of the image by a breast radiologist must accompany CAD.
It has been suggested that CAD in conjunction with mammography screening could replace one of the two independent readings that are done in accordance with European and Swedish guidelines. A prerequisite would be that the diagnostic accuracy and patient benefit are as good when the images are read by one breast radiologist plus CAD as when they are read by two breast radiologists. Another important prerequisite is that not too many women need to be called back for further diagnostic work-up (recall). In Europe, the highest recommended recall rate is 5 percent.
High average age among practicing breast radiologists, and poor replacement rate in this group of specialists, has increased the interest for computerised analysis of mammography images.
In this report we have studied whether diagnostic accuracy is at least as good, while recall rates are not higher, when CAD plus single reading by one breast radiologist is used in conjunction with mammography screening instead of independent readings by two breast radiologists.
Is the reading of mammographic images by a single breast radiologist plus CAD at least as accurate as readings by two breast radiologists (current practice) in terms of:
The report includes population-based screening studies only. The studies should include at least 5 000 women and the study settings should be comparable to Swedish conditions. Furthermore, the studies should compare mammography readings by one breast radiologist plus CAD against readings by two breast radiologists. Since prospective studies based on digital mammography could not be identified, scanned analogue images were accepted.
Recall increases short-term anxiety among the women affected and also increases cost. Therefore, the requirement for using single reading plus CAD is that the method must detect at least as many cancers as double reading, without increasing the recall rate, i.e. the method’s specificity must be at least as high as that in double reading.
Only one study of sufficient quality met the inclusion criteria. It compared single reading plus CAD with double reading in conjunction with mammography screening, and reported no difference in the percentage of cancer cases detected. The recall rate, however, was statistically significantly higher for single reading plus CAD (3.9 percent compared to 3.4 percent for double reading). The generalisability of the study is reduced since all of the breast radiologists participating in the study had extensive experience in mammography screening. Therefore, this single study, having deficiencies in study quality and generalisability, cannot be used to draw conclusions (insufficient scientific evidence ).
SBU’s assessment shows that the scientific evidence is insufficient to comment on single mammographic reading by one breast radiologist plus CAD in comparison to current practice of double reading involving two breast radiologists.
Since the medical consequences are uncertain, it is not possible to determine the cost-effectiveness and/or the socioeconomic consequences of replacing one of the readings with CAD in the context of mammography screening.
Four levels are used in grading the strength of the scientific evidence on which conclusions are based:
Strong scientific evidence (). Based on high or medium quality studies with no factors that weaken the overall assessment.
Moderately strong scientific evidence (). Based on high or medium quality studies with isolated factors that weaken the overall assessment.
Limited scientific evidence (). Based on high or medium quality studies having factors that weaken the overall assessment.
Insufficient scientific evidence (). Scientific evidence is deemed insufficient when scientific findings are absent, the quality of available studies is low, or studies of similar quality present conflicting findings.
presents a comprehensive, systematic assessment of available scientific evidence. The certainty of the evidence for each finding is systematically reviewed and graded. Full assessments include economic, social, and ethical impact analyses.
SBU assessments are performed by a team of leading professional practitioners and academics, patient/user representatives and SBU staff. Prior to approval and publication, assessments are reviewed by independent experts, SBU’s Scientific Advisory Committees and Board of Directors.