Tuesday, November 30, 2010

CBE FOR THE MAMMOGRAPHER - Part 2: Interpretation and Follow-up



Well, it is well into Autumn here but the weather is holding pretty well so far. No snow yet right in Toronto but the surrounding northern 'burbs have got some already. Thanksgiving is coming up for my US colleagues so a very happy TGing to y'all.


November's techtalk continues with our skills regarding patient assessment in the form of CBE. Enjoy and pass it on. Remember, don't fear new skills and responsibilities, embrace them. Knowledge is power!


Keep in touch,
Anne


OBJECTIVES:
With the constant changing of the expectations of DI personnel our scope of practice changes year on year, full patient assessment now often comes into our scope of practice. With that in mind, the mammographers responsibilities in regards to Clinical Breast exam broaden somewhat.

I will present recommendations in three areas, the clinical breast examination itself, interpretation/ report/follow-up, and overcoming barriers to performance. Some recommendations can be implemented immediately within clinical settings, and clinicians are encouraged to lead this effort. Others will require partnerships between the clinical community and health care organizations to establish systems, increase awareness, and gather necessary information to achieve outcomes.

CLINICAL BREAST EXAMINATION 
The premise underlying CBE is that visually inspecting and palpating of the breast and surrounding tissue can detect breast abnormalities. CBE is considered to include a continuum of integrally related components, from the examination itself, to interpretation and reporting of findings, to patient follow up. The recommendations for performance in this article represent general standards that can be immediately disseminated and adopted based on current evidence. 

Neither CBE nor mammography is a substitute for the other as an independent examination for detecting breast abnormalities. When a suspicious mass is found on CBE, it must be evaluated and explained even if mammography examination does not show an abnormality.

Interpretation and Reporting Overview:
  1. Reporting should consist of a summary of the relevant portions of a patient’s history and a description of whether the CBE is interpreted as normal/negative or abnormal. If abnormal, include a description of the visual and palpable findings, including changes in the appearance of skin or nipples, the presence of nipple discharge, the presence of breast masses or palpable asymmetries, and the presence of palpable lymph nodes.  
Lead responsibility for implementation: clinicians and health care organizations. 
  1. Develop a consistent, standardized lexicon of terms and format for documenting the interpretation and reporting of specific CBE findings.
Lead responsibility for implementation: health care organizations.


The primary function of CBE is to identify abnormalities that warrant further evaluation; CBE alone is not capable of accurately distinguishing benign from malignant status. Interpreting the visual and tactile observations of CBE is complex. A variety of patient characteristics can influence interpretation, including age, parity, tissue density and nodularity, menopausal status, phase of the ovarian cycle, and health history. For example, bloody nipple discharge during the last trimester of pregnancy or the first 3 months of lactation may be considered a normal physiologic change, but it would be interpreted quite differently in a woman who was not pregnant or lactating. Similarly, skin erythema or lymphedema would not necessarily be cause for further evaluation in a woman having recently undergone radiation therapy of the breast but would certainly require follow up in a woman without such a history. A more common and difficult challenge involves breast lumpiness or nodularity, which varies considerably among women and over time for the same woman. For example, increased nodularity might be normal during the luteal phase of the menstrual cycle, but at other times it might be cause for further examination. 


As with the performance of CBE, no standard system exists for interpreting or reporting CBE findings. Little standardized terminology exists for describing findings such as degree of nodularity; thickening versus a mass; dimpling of skin; or the size, mobility, shape, or consistency of an abnormality. Thus, even if CBE was performed uniformly to its highest potential sensitivity and specificity, differences in interpretation and how findings are reported limit its potential benefits in guiding further evaluation and permitting earlier treatment of breast cancer. Efforts to improve the interpretation of mammography reporting and subsequent associated management recommendations have resulted in improvements in accuracy and consistency in those areas, but several studies demonstrate the importance of continued system refinement and training. 

An important byproduct of standardizing interpretation and reporting is the potential to provide data for more accurate estimates of sensitivity and specificity in clinical practice settings. Estimates of false-positive and false-negative results based on reporting and medical records data could be used to provide feedback to health care professionals to improve their proficiency. 

Information about the number of cancers first identified by CBE, particularly as a function of age and other population characteristics, could help clarify the role of CBE as a component of early detection and the use of this examination in relationship to other screening modalities.

Interpretation:
Interpretation involves three elements:
  • Identification of visual and palpable characteristics of the breasts and lymph nodes
  • Accurate assignment of specific, common, descriptive terminology to each characteristic
  • Determination of appropriate follow-up actions for identified finding
The interpretation and reporting elements described below provide a general framework for identifying all relevant features of a proficient CBE, describing visual and physical findings, and reporting these findings and follow-up recommendations. This framework is general, representing an important initial step in the process of developing a standardized lexicon and patient follow up, as well as a reporting format for CBE. The role of CBE is to identify and appropriately describe visual and palpable findings; determination of benign or malignant status can be established only through further evaluation. Examiners are encouraged to adopt and begin implementing this framework for CBE interpretation and reporting. Development and implementation of a detailed system, as well as analysis of reporting data, must be undertaken as a partnership between clinicians and health care organizations.


The results of CBE can be interpreted in two ways:
  • Normal/Negative: No abnormalities on visual inspection or palpation.
  • Abnormal: Asymmetrical finding on either visual inspection or palpation that warrants further evaluation and possible referral. Findings will reflect a continuum of possible outcomes, from probably benign to highly suspicious of cancer. Determination of benign or malignant status, however, can be established only through further evaluation.
Reporting:
Reporting should include a description of all findings in specific and precise language, regardless of interpretation. In the case of a negative interpretation, description of findings provides a baseline for interpreting future results from visual inspection and palpation. In the case of an abnormal interpretation, a description provides an important guide for follow-up examination.

Reporting should follow the same sequence as the examination itself. The following outline directs providers’ attention to those aspects of the exam that represent unique patient characteristics or abnormalities. To the extent possible, electronic reporting should be encouraged to provide compatibility with existing medical records systems and more efficient analysis of reporting trends.


 Normal/Negative CBE: Normal Breast Characteristics
Clinical history – describe:
  • Breast screening practices
  • Breast changes
  • Risk factors for breast cancer
  • Hormonal factors at time of examination (e.g., time in menstrual cycle, pregnancy, breast feeding, hormonal contraceptives, hormone therapy)
Visual inspection – describe:
  • Scarring.
  • Symmetry of breast shape and appearance of skin and nipple-areolar complex.
  • Palpation of lymph node – describe results with respect to:
    • Infra- and supraclavicular nodes
    • Axillary nodes
Breast palpation – describe results with respect to:
  • Nodularity
    • Normal nodularity should not be described as a fibrocystic condition
    • Normal cyclic breast tenderness should not be described as a pathologic condition
  • Symmetry.
    • Tenderness (focal versus generalized and constant versus intermittent)
Abnormal CBE: Abnormal Breast Characteristics
Clinical history – describe:
  • Breast screening practices
  • Breast changes
  • Risk factors for breast cancer
  • Hormonal factors at time of examination (e.g., time in menstrual cycle, pregnancy, breast feeding, hormonal contraceptives, hormone therapy)
Visual inspection – describe:
  • Contour (skin retraction, dimpling)
  • Color (erythema)
  • Texture (skin thickening or lymphedema)
  • Skin retraction or dimpling
  • Nipple scaling or retraction
  • Nipple inversion (age of onset during adulthood)
  • Location of abnormal findings or mass according to a clock face as the examiner faces the patient, clearly indicating whether the abnormality is in the right or left breast
  • Size/extent of abnormal finding or mass
Palpation – for each palpable abnormality (including breast tissue and infraclavicular, supraclavicular, and axillary lymph nodes), describe:
  • Three-dimensional dominant mass or two-dimensional thickening
    • Location in three dimensions (subcutaneous, midlevel, next to chest wall, and according to a clock face as the examiner faces the patient)
  • Size
  • Shape (round, oblong, irregular, lobular [having one to four rounded or curved extensions from a central mass]).
  • Mobility (mobile, fixed to skin or chest wall).
  • Consistency (soft, similar to surrounding breast tissue, hard).
  • External texture (smooth, irregular [having bumps distributed over the external surface of the mass]).
  • Nipple discharge.
    • Spontaneous
    • Color.
    • Number of involved ducts.
    • Right or left breast or both.
Follow Up:
The final but equally important component of the CBE is follow up; different types of findings will require different follow-up actions, but appropriate follow up is essential. Adopt a standardized approach to follow up that provides continuous care to the patient until an appropriate resolution of findings is reached. This approach should make use of all appropriate follow-up options, ensure appropriate timing of subsequent actions, involve communication and coordination with other providers, and include proper documentation and tracking.


Follow Up for Normal/Negative CBE
In the case of a normal/negative CBE, a repeat CBE at the next screening interval or preventive health examination is the appropriate follow up. Descriptive findings from the normal/negative CBE should serve as the baseline for the next interval CBE


Follow Up for Abnormal CBE
In the case of an abnormal CBE, the provider should not discount an abnormal CBE because of
 a negative mammogram or other imaging examination. 


Providers must follow up all conflicting or abnormal findings to satisfactory resolution using the actions outlined below.
  • All referrals must ensure that a copy of the CBE report is provided to specialists performing follow-up imaging to assist in examination and interpretation
  • One or more of the following follow-up options are available
    • Repeat CBE.
    • Medical management of probably benign condition
    • Referral to a breast specialist
    • Imaging (ultrasound, mammography, and magnetic resonance imaging)
    • Aspiration
    • Biopsy (percutaneous or excisional)
Follow-up Timing
The timing of follow-up actions must be appropriate to the findings and should be designed to minimize patient burden and psychological stress. For women aged 40 and older, a repeat CBE in the case of negative findings will likely occur as part of the woman’s regular preventive health care. Among women aged 40 and younger with a negative CBE, this interval may be longer. In the case of abnormal findings, follow up should take place at a shorter interval, at least within 6 months and usually within a shorter time frame.


Coordination of Follow-up
If follow up is necessary, examiners may need to work with other care providers, including radiologists, oncologists, surgeons, and other breast health specialists. Clear communication about follow up and effective coordination of any follow-up actions are essential.


Tracking to Ensure That Follow Up Has Occurred
Appropriate tracking must be in place to ensure that follow up has occurred. This involves making adequate documentation, reminders to resolve outstanding issues or patient questions, having a system for patient callback and reminders, and taking actions to obtain patient feedback.


SUMMARY:
As laws change, medical teams form and shift, multi disciplinary education becomes normal and hybrid and fusion imaging becomes standard practice our responsibilities as clinicians expand and evolve. As professionals we are expected to rise to the challenges presented to us.
With education, practice and experience we can embrace these new proficiencies and continue to serve our patients with skill and renewed efficacy. Knowledge is power!