Question

Is a clear and systematic reporting of radiological examinations essential for good quality breast care?

Recommendation

Mammography indications:

  • Screening within the framework of the national breast screening programme
  • Screening in relation to increased risk
  • Within the framework of symptomatology (in women and men > 30 years)
  • Within the framework of metastases of an unknown primary malignancy: only if there are clinical or pathological signs for malignancy

 

Ultrasound indications:

  • Examination of first choice for young (< 30 years) symptomatic women (and men if applicable)
  • Examination of first choice for symptomatic women who are pregnant or breastfeeding
  • Additional examination to further characterise a mass detected on a mammogram
  • Additional examination to further analyse a palpable abnormality that is indistinct or occult on the mammogram
  • Additional examination to further analyse a non-palpable finding on a mammogram
  • Additional examination to further analyse an incidental laesion found on MRI
  • For the purposeof an ultrasound-guided punction or biopsy

 

Operating and reporting on mammography and ultrasound:

  • If mammography is indicated for young, pregnant and breastfeeding women after having undergone an ultrasound, this should be performed directly afterwards
  • The radiology report should correlate the symptomatology with the integrated radiology findings
  • If multiple imaging types are performed during one visit, an integrated report should be made, in which the examination with the highest suspicion for malignancy should be the deciding factor
  • The report should be completed with a conclusion and recommendations, in which the BI-RADS final assessment category must be assigned

 

BI-RADS 3

  • Assigning the final assessment category BI-RADS 3, probably benign, is reserved for the group of abnormalities that the radiologist thinks is benign, i.e. the chance of malignancy is less than 2%.
  • The manner in which a BI-RADS 3 laesion is dealt with may differ and is dependent on the possibilities in relation to punction, but also the wishes of the patient and preference of the radiologist. On this basis, a choice should be made between a punction or short-term follow-up (6 months). In the case of a fibroadenoma, a single follow-up in 6 months is sufficient; for microcalcifications, follow-up in 6 months is recommended, and then further follow-ups after 12 and 24 months.
  • If a patient has a BI-RADS 3 laesion, and is referred by the national breast screening programme, a punction should be chosen (where possible) so that the patient can be directly referred back to the national breast screening programme if the result is benign.
  • Additional MRI for BI-RADS 3 laesions as an alternative for follow-up of biopsy is not recommended.

 

BI-RADS 4 and 5

The manner in which a BI-RADS 4 and 5 laesion is dealt with is uniform: tissue sampling for pathology is mandatory. By exception with BI-RADS 4 abnormalities, short-interval follow-up after 6 months may be chosen if decided by the breast care team on the basis of good arguments.

Conclusions

Level 1

For good quality breast care, clear and systematic reporting of radiological examinations is essential.

The routine assigning of BI-RADS final assessment categories reduces interobserver and   intraobserver variability.

 

A1    ACR 2003

A2    Caplan 1999, Lehman 2002, Monticciolo 2004

Literature summary

The below text has made use of Kerlikowske (2003), three interobserver studies with screening populations [Caplan, 1999; Lehman, 2002; Monticciolo, 2004], three studies with selected abnormalities on mammography and ultrasound [Berg, 2002; Lazarus, 2006; Burnside 2007] and the BI-RADS atlas.

BI-RADS has been developed by the American College of Radiologists [ACR, 2003]. The system was established in 1994 and consists of an atlas, in which standardised terminology is covered for the purpose of a standardised compiled report, with the aim of improving uniformity in intercollegial communication and reducing confusion. In relation to mammography and ultrasound, the criteria from which the final assessment categories have been derived, are based on publications on the diagnostic value of these criteria and can therefore be considered evidence-based. Application of the system was initially limited by interobserver variation, this decreased as the system became more common. The percentage of mammography reports in which the BI-RADS final assessment category has been assigned is an internal indicator in the quality assurance audits of the NVvR (Radiological Society of the Netherlands).

 

The report

A good report begins with a good imaging request. This should contain information about the complaint or the symptomatology, risk profile and history as well as clinical breast examination (also see 2.1).

If more than one type of imaging is performed in one sitting, all types should be included in the same report with one integrated conclusion and final assessment category to facility clarity.

 

A report should be succinct and follow the structure determined by BI-RADS:

  1. It should state the indication for the imaging study;
  2. Describe the breast composition in a semi-quantitative manner (not: very good, good, moderate, poor):

    ACR 1       The breast is almost entirely fat (< 25% breast tissue);

    ACR 2       There are scattered fibroglandular densities (25-50% breast tissue)

    ACR 3       The breast tissue is heterogenously dense (51-75% breast tissue)

    ACR 4       The breast tissue is extremely dense (> 75% breast tissue)

  3. Describe any new findings or changes compared to previous images, including size and localisation. Correlation with symptomatology.
  4. Concluding description followed by a BI-RADS final assessment category, showing the level of suspicion, and recommendations in relation to follow-up or additional imaging if indicated.

 

BI-RADS final assessment categories and clarification

If both mammography and ultrasound are performed, an integrated report should be formulated; the deciding factor in the BI-RADS final assessment category is the modality with the highest suspicion of malignancy.

Note that the presence of extremely dense breast tissue does not influence the BI-RADS final assessment category. In the final assessment category, the radiologist should express the extent to which an abnormality is radiologically suspect for malignancy, independent of density or the ability to evaluate the tissue.

 

BI-RADS 0 (Incomplete study)

Additional imaging is indicated. Examples are magnification views, ultrasound or comparison with previous studies that are not available. Many mammographic examinations performed during screening, which are eligible for referral, belong to this category. In radiology departments, this category should be applied as a provisional result and attempts towards completion should be made as fast as possible.

 

BI-RADS 1 and 2 (Negative and Benign)

The distinction between BI-RADS 1 and 2 is somewhat artificial, but may assist the treating physician with the discussion about a finding on the mammogram with radiological benign characteristics, such as a benign calcification or an oil cyst. Typical ultrasound BI-RADS 2 abnormalities are cysts and solid abnormalities with benign characteristics, which are stable over time. The BI-RADS 2 category is chosen if there is status after surgery, such as breast-conserving treatment, breast reduction and breast augmentation.

The percentage of malignancies in these categories should be extremely small, but will never be nil, because false negative findings are inevitable.

 

BI-RADS 3 (Probably benign)

This final assessment category is reserved for abnormalities on mammography or ultrasound, where the radiologist estimates the risk of malignancy to be so low (< 2%), that short-interval follow-up is deemed adequate. This usually concerns abnormalities with benign aspect, in which imaging for comparison is available, such as solid laesions (on ultrasound) with round, oval or lobulated contours, (mammographically) well-defined laesions, small groups of round or oval microcalcifications or focal asymmetry of the breast tissue.

The manner in which a BI-RADS 3 laesion is dealt with in the Netherlands differs from the recommendations by the ACR (2003), due to a difference in organisational structure. The guideline development group is of the opinion that aside from short-interval follow-up, a biopsy may also be chosen. If follow-up is chosen, then follow-up any earlier than 6 months later is generally not worthwhile [Graf, 2004; Vizcaino, 2001]. After 6 months, a recommendation may be made whether further follow-up needs to be performed after 12 and 24 months. The radiologist also has a choice here: the duration of follow-up may be applied to the age of the patient and the laesion type: in the case of a young woman with a small, typical fibroadenoma, one-off follow-up after 6 months is sufficient. Complete follow-up through to 24 months can be chosen for an older woman with a cluster of probably benign microcalcifications. If the laesion remains stable over time, the final assessment category can be changed to BI-RADS 2 (benign).

The most important disadvantage of follow-up is the chance that the patient does not follow this recommendation. This was the case for 16-18% of patients in various studies [Varas, 2002; Zonderland, 2004].

If a biopsy is chosen (cytological punction or needle biopsy) and the results are representative and correlate with the imaging (e.g. fibroadenoma), then the diagnostics are complete and follow-up is no longer necessary.

The choice between follow-up or biopsy is dependent on the technical possibilities for biopsy, the wishes of the patient and the preference of the radiologist. On the basis of currently available literature, there are insufficient indications that MRI provides added value [AHRQ, 2006; Peters, 2008], see 2.2.5.

 

BI-RADS 4 (Probably malignant)

If an abnormality is assigned BI-RADS 4, it needs to be taken into account that the abnormality may still be benign. The chance of malignancy within this category can vary highly, from 2-95%; subclassifications may therefore be used as an option, namely:

  • BI-RADS 4a (low suspicion)
  • BI-RADS 4b (intermediate      suspicion) and
  • BI-RADS 4c (of moderate concern,      but not classic)

This refinement is of importance with microcalcifications and benign biopsy results that are indistinct, see 4.1.3. Microcalcifications may be subdivided according to the BI-RADS assessment categories into round and punctate, milk of calcium, amorphous, coarse heterogenous, fine pleomorphic, fine linear, and branching calcifications.The order corresponds to increasing risk of malignancy.The distribution pattern, diffuse distribution, regional, clustered, linear or segmental, may play a role in determination of the risk of malignancy.In a retrospective study of 115 biopsies, Burnside (2007) described a good correlation between the morphology of microcalcifications and the estimated risk of malignancy.The amorphous and coarse heterogenous microcalcifications were less often associated with malignancy (7 and13% respectively) compared to fine pleomorphous and fine linear/branching microcalcifications (29 and53% respectively).

 

The essence of assigning a BI-RADS 4 is that tissue for pathology must be obtained that correlates with the radiology. Short-interval follow-up is not sufficient, unless this has been decided by the breast care team on the basis of good arguments.

 

BI-RADS 5 (Highly suggestive of malignancy)

This category is assigned to an abnormality that is highly suggestive of malignancy, with a greater than 95% likelihood of malignancy. There are often secondary characteristics of malignancy. If the obtained pathological material still yields a benign result, there needs to be consultation within the breast care team whether there may have been a sample error.

 

BI-RADS 6 (Biopsy- proven malignancy)

The number of patients with large tumours or locoregional extended disease who are treated pre-operatively with neoadjuvant chemotherapy or radiotherapy is on the increase. The effect of such therapy is monitored using imaging. This category has been created for this group of people, because the typical abnormalities may disappear as a result of therapy, while there may still be malignant tissue in the breast. This category is therefore not intended for imaging for patients that have already undergone surgery.

 

Table 1.Final assessment categories: BI-RADS mammography and ultrasound

Final assessment category

Description

0

Incomplete examination: additional imaging evaluation indicated and/or prior mammograms for comparison

1

Normal, there is nothing to comment on

2

Benign finding, e.g. a cyst, a known or calcified fibroadenoma or postoperative status

3

Probably benign finding: The radiologist thinks the laesion is benign, but prefers confirmation by means of a short-interval follow-up (6 months) or by means of a punction

4

Probably malignant, suspicious laesion:

4a. low suspicion, malignancy cannot be excluded

4b. intermediate suspicion of malignancy

4c. moderate suspicion, not classic

5

Highly suggestive of malignancy

6

Biopsy- proven malignancy

Considerations

Patients referred by the national breast screening programme form a separate group. They (usually) do not have any symptoms, but an abnormality on the screening mammogram. Section 1.3.2. describes how this should be dealt with. For most patients, the mammogram and ultrasound can be used to explain the referral indication and assign a definitive, diagnostic BI-RADS final assessment category. For a small proportion, the abnormalilities that are cause for referral are not detected on the mammogram in the hospital and can at the most be interpreted as fibroglandular tissue. A BI-RADS 1 can then be assigned and patients can immediately return to the national breast screening programme. In a few cases, e.g. with focal asymmetry, a BI-RADS 3 (probably benign) can be assigned and a 6 month follow-up recommended, after which the patient returns to the national breast screening programme. Given this concerns asymptomatic women from the general population with low suspicion of malignancy, an MRI is also not indicated in this group.

 

There must not be more than two working days between performing the examination and reporting. Requesting mammograms that have been taken elsewhere must also not delay reports, any comparisons performed at a later point in time may be mentioned in an appendix. Assigning a BI-RADS 0 may only be applied if the comparison with previous mammograms is absolutely necessary for the conclusion. Each radiology unit should consider striving for a comprehensive system in relation to requesting previous mammograms from elsewhere and follow-up recommendations. Recommendations by a radiologist are not binding, although it is adviced that a multidisciplinary decision for a change in patient management is also recorded in an appendix. Finally, it remains important to also communicate personally unexpected findings with the requesting physician.

Authorization date and validity

Last review : 13-02-2012

Last authorization : 13-02-2012

The national Breast Cancer guideline 2012 is a living guideline, in other words there is no standard term of revision. NABON continually watches at new developments and clinical problems in the areas of screening, diagnostics, treatment and aftercare, and whether this requires an update.

Initiative and authorization

Initiative : Nationaal Borstkanker Overleg Nederland

Authorized by:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Psychiatrie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie

General details

Approximately 14,000 women (and 100 men) are diagnosed with invasive breast cancer each year in the Netherlands, and about 1,900 have an in situ carcinoma. A woman's risk of having breast cancer over the course of her life is 12-13%. This means that breast cancer is the most common form of cancer in women in the Netherlands. Early detection, particularly via national breast cancer screening, combined with adjuvant therapy followed by locoregional treatment, improves the prognosis in women with breast cancer

The guideline on Breast Cancer Screening and Diagnostics, published in 2000, was updated in 2007. In 2002, the first multidisciplinary National Breast Cancer Guideline was published, it was revised in 2004, 2005 and 2006. In 2008 both guidelines were combined to Breast Cancer Guideline, which 2012 revision is now effected.

Scope and target group

This guideline is written for all the members of the professional groups that have contributed to its development.

 

This guideline is a document with recommendations and instructions to support daily practice. The guideline is based on the results of scientific research and expert opinion, with the aim of establishing good medical practice. It specifies the best general care for women with (suspected) breast cancer and for those who are eligible for screening. The guideline aims to serve as a guide for the daily practice of breast cancer screening, diagnostics, treatment and aftercare. This guideline is also used in the creation of informational materials for patients, in cooperation with the KWF (Dutch Cancer Society).

Member of workgroup

A core group consisting of a radiologist, surgeon, pathologist, medical oncologist and radiation therapist began preparing for the revision of the breast cancer practice guidelines in 2009. A multidisciplinary guideline development group was formed in early 2010 to implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society) (see list of guideline development group members). The benefits of such a multidisciplinary approach are obvious: not only does it best reflect the care, but it offers the greatest possible expertise for the guideline. In composing the development group, geographic distribution of the members, balanced representation of the various organisations and agencies concerned, and a fair distribution in academic background were taken into account as much as possible.

 

The guideline development group received procedural and administrative support from IKNL (Comprehensive Cancer Centre for the Netherlands) and support on methodology from Bureau ME-TA. Partial funding was obtained from SKMS (Quality Funds Foundation of Dutch Medical Specialists). This subsidy would not have been possible without the extensive assistance provided by the NVvR (Radiological Society of the Netherlands).

Declaration of interest

Partial funding for the guideline revision was obtained from the Society of Dutch Medical Specialists in the framework of the SKMS. IKNL sponsored some of the cost. On two occasions, as well as at the beginning and end of the process, all of the members of the guideline development group were asked to fill out a statement of potential conflicts of interest, in which they stated their relationship with the pharmaceutical industry. A list of these statements of interest can be found in the appendices.

Patient involvement

In developing this guideline, four clinical questions were formulated. These questions emerge from an inventory of clinical problems collected in the field from professionals, patients and patient representatives.

 

Also, A multidisciplinary guideline development group was formed in early 2010 to create and implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society).

 

Method of development

Evidence based

Implementation

Feasibility has been taken into account in developing the guideline. This included attention to factors that could promote or hinder putting the advice into practice. Examples include the implementation of an analysis of problems, the multidisciplinary composition of the guideline development group, and making active use of support from the guideline development group members. Presenting the draft guideline to the field and communicating what, if anything, is being done with the responses, also promotes implementation. In this manner, a guideline has been developed that answers current questions in the field.

The guideline is distributed widely and is available in digital form on the Dutch Guideline Database. The guideline may also be brought to the attention of a wider audience in other periodicals or continuing education sessions, for example. To promote use of the guideline, we recommend that the regional tumour working groups and group practices, as well as scientific and professional organisations, repeatedly bring the guideline to the attention of their members. Any problems that may arise in using the guidelines can then be discussed and, when appropriate, submitted to the national guideline development group, as it is a "living" guideline. If desirable, parts of the guideline can be made more explicit by formulating regional additions or translation to the local situation in departmental and/or hospital protocols.

In principle, indicators are determined during development of the guideline that can be used to monitor implementation of the recommendations. Via a documentation project, these indicators can then be used to determine the extent of compliance with the guideline. The information from the documentation project becomes input for the revision of the guideline.

Methods and proces

This module has been evidence-based revised in 2008 and consensus based updated in 2012.

 

A revision of an existing guideline consists of revised and updated text. Revised text is new text based on an evidence-based review of the medical literature; updated text is the old guideline text which has been edited by the experts without performing a review of medical literature. Each section of the guideline states what type of revision has taken place. Each chapter of the guideline is structured according to a set format, given below. The purpose of this is to make the guideline transparent, so that each user can see on what literature and considerations the recommendations are based on.

 

Description of the literature

To the greatest extent possible, the answers to the fundamental questions (and therefore the recommendations in this guideline) were based on published scientific research. The articles selected were evaluated by an expert in methodology for their research quality, and graded in proportion to evidence using the following classification system:

 

Classification of research results based on level of evidence

A1

Research   on the effects of diagnostics on clinical outcomes in a prospectively   monitored, well-defined patient group, with a predefined policy based on the   test outcomes to be investigated, or decision analysis research into the   effects of diagnostics on clinical outcomes based on results of a study of   A2-level and sufficient consideration is given to the interdependency of   diagnostic tests.

A2

Research   relative to a reference test, where criteria for the test to be investigated   and for a reference test are predefined, with a good description of the test   and the clinical population to be investigated; this must involve a large   enough series of consecutive patients; predefined upper limits must be used,   and the results of the test and the "gold standard" must be   assessed independently. Interdependence is normally a feature of situations   involving multiple diagnostic tests, and their analysis must be adjusted   accordingly, for example using logistic regression.

B

Comparison   with a reference test, description of the test and population researched, but   without the other features mentioned in level A.

C

Non-comparative   trials

D

Opinions   of experts, such as guideline development group members

 

Conclusions

Based on the medical literature, one or more relevant conclusions are made for each section. The most important literature is listed according to the level of evidential strength, allowing conclusions to be drawn based on the level of
evidence. All the medical literature included in the conclusion is described in the bibliography.

 

Classification of conclusions based on literature analysis

1

Based   on 1 systematic review (A1) or at least 2 independent A2 reviews.

2

Based   on at least 2 independent B reviews

3

Based   on 1 level A2 of B research, or any level C research

4

Opinions   of experts, such as guideline development group members

 

Other considerations

Based on the conclusion(s), recommendations are made. However, there are other considerations that contribute to formulation of the recommendation besides literature evidence, such as safety, the patients' preferences, professional expertise, cost-effectiveness, organisational aspects and social consequences. The other considerations are mentioned separately. In this manner, it is clear how the guideline development group arrived at a particular recommendation.

 

Recommendations

The final wording of the recommendation is the result of the scientific conclusion, taking into account the other considerations. The purpose of following this procedure and drawing up the guidelines  in this format is to increase transparency.

 

References

An alphabetical list of literature references can be found at the end of the guideline.

 

All draft texts have been discussed by the guideline development group.

Search strategy

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