Is clinical breast examination a viable way of determining breast cancer?
Clinical breast examination is part of the consultation.
Clinical breast examination is indicated when there are symptoms and when palpable abnormalities are found by the woman herself during a self-exam.
For women in the general population without a history of breast cancer, clinical breast examination as a screening method in addition to imaging has very limited added value for finding a primary breast carcinoma, and is therefore not recommended.
Clinical breast examination in women who are screened outside the national breast screening programme has limited added value.
Clinical breast examination combined with mammography for breast cancer screening has a low sensitivity and a high percentage of false-positive findings, and is therefore not cost-effective.
Level 1: A1 Nelson 2009, A2 Oestreicher 2005, Chiarelli 2009, B Feigin 2006, Elmore 1998, Bobo 2000, Elmore 2005, Pisani 2006
In women with an increased risk of breast cancer, the number of false-positive palpation findings is slightly more favorable than with mammography and MRI.
Level 3: A2 Rijnsberger 2010
The same four systematic reviews that evaluated screening by periodic breast self-exam also assessed screening by clinical breast exams [Kösters, 2003; Weiss, 2003; Elmore, 2005; Nelson, 2009]. Barton conducted a meta-analysis of clinical breast examinations in 1999. Besides these, there are cohort studies comparing clinical breast examination to imaging techniques, in particular mammography, as screening methods. The CNBSS-2 study [Miller, 2000] is an RCT with clinical breast examination as one of the study arms. Especially in the large studies, clinical breast examination is performed by trained health care staff. One of the differences between breast self-examination and clinical breast examination is the quality standards that can be placed on clinical breast examination. Studies indicate that a good clinical breast examination requires training and takes time, at least several minutes. When these conditions are met, no difference in quality is reported between the results from doctors and from other health care staff [Coleman, 2001]. Kösters (2003) is less clear with respect to clinical breast examination than breast self-examination.
In studies, the sensitivity and positive predictive value are limited. Feigin (2006) describes a retrospective study on the role and costs of clinical breast examination by nurse practitioners compared with mammography in 60,027 asymptomatic women. Without clinical breast examinations, 3% of cancers would have been missed. The costs were over $122,000 per cancer found.
The results are highly dependent on the composition of the population. In the prospective study conducted by Oestreicher (2005) in 61,688 asymptomatic women of age 40 and older, the mean sensitivity was 4% and was highest in women between the ages of 50-59 with dense breasts (6.8%) and lowest in women between the ages of 50 and 59 with adipose breasts (1.8%).
In an observational study, Chiarelli (2009) compared screening units where only mammography was performed with screening units in which mammography and clinical breast examination were conducted. In the latter group, 4 more cancers were found in 10,000 women, compared to 219 false-positive findings.
Similarly, very few additional cancers are found when women at high or very high risk are screened using clinical breast examination in combination with mammography and MRI [Warner, 2004]. These studies contain relatively small populations. In the MRISC screening study [Rijnsburger, 2010] the sensitivity is 20.6%. Out of 98 breast cancers, 3 were exclusively detected using clinical breast examination. At 10.3%, the positive predictive value is slightly better than that of mammography (8.5%) and MRI (7.7%).
Clinical breast examination, which can detect presymptomatic cancers, is an integral part of every consultation for women with breast pathology. This method can be used as a screening method in areas of the world where screening mammography is unavailable. However, regular clinical breast examination in addition to imaging as a selected screening method is not cost-effective in the general population of the Netherlands.
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 NederlandAuthorized by:
- Nederlandse Internisten Vereniging
- Nederlandse Vereniging voor Heelkunde
- Nederlandse Vereniging voor Psychiatrie
- Nederlandse Vereniging voor Radiologie
- Nederlandse Vereniging voor Radiotherapie en Oncologie
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).
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.
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
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
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.
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.
Comparison with a reference test, description of the test and population researched, but without the other features mentioned in level A.
Opinions of experts, such as guideline development group members
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
Based on 1 systematic review (A1) or at least 2 independent A2 reviews.
Based on at least 2 independent B reviews
Based on 1 level A2 of B research, or any level C research
Opinions of experts, such as guideline development group members
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.
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.
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.
Searches are available upon request. Please contact the Richtlijnendatabase.
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