Tallis Training

Triple Assessment In detail

  1. The Candidate placeholder enquiry is separated from the rest of the workflow. Contrary to the other enquiries in this process, it does not collect data from the end-user, but from the process itself. It holds data items that are assigned values at runtime. As the status of the data items is set to optional and they all have a default values, they are not displayed to the end-user. The data items’ use will be clarified in the following sections.

  1. The first task in the Triple Assessment workflow is the Clinical examination and genetic risk assessment plan. This plan introduces the first of the four decisions modelled in this sample – the familial genetic risk assessment decision.

  1. First, the Patient demographics enquiry collects data about the patient’s age, gender and ethnicity.

  1. Then the Patient history plan collects further data about the patient.

  1. The Patient history enquiry collects a large number of data items, some of which are interdependent. In order to enable and disable certain data items according to the end-user’s responses to other data items, a customised HTML page was created for this enquiry (the reference to the customised pages for this and other tasks is in the Context tab of the top-level plan). Running the Triple Assessment application without this customised page would result in all data items being enabled and displayed on the screen haphazardly (this is what happens when you run the application in the Tallis Tester, which ignores customisations).

Note: The status of dependent data items is set to optional, so that the enquiry can complete even if the data is not collected.

  1. If the patient has a family history of cancer, the Get patient details enquiry follows the Patient history enquiry and collects more information about the family history; otherwise it is discarded. Once again, a customised page was created for this enquiry: it invokes an application for genetic risk assessment, which provides a user-friendly interface for entering family history data.

  1. Additional data about genetic predisposition and genetic risk factors is collected by the Get Further Data enquiry, as this information is not collected by the genetic risk assessment application.

  1. The Familial Genetic Risk Assessment decision runs after all relevant data has been collected (either immediately after the Patient history enquiry or after the Get Further Data enquiry). It has three candidates: HIGH (greater than 25% lifetime risk), MEDIUM (17 - 25% lifetime risk) and LOW (less than 17% lifetime risk).

The arguments for the HIGH candidate are:

  • One first degree relative (FDR) or second degree relative (SDR) with a diagnosis of bilateral breast cancer (BrCa) AND one FDR or SDR diagnosed with BrCa before the age of 60
  • One FDR or SDR with a diagnosis of bilateral BrCa before the age of 50
  • One male BrCa AND one FDR or SDR with a diagnosis of BrCa before the age of 50
  • One male BrCa AND two FDRs or SDRs diagnosed with BrCa before the age of 60
  • One FDR or SDR diagnosed with ovarian cancer (OvCa) at any age AND one FDR or SDR with a diagnosis of BrCa before the age of 50
  • One FDR or SDR diagnosed with OvCa at any age AND two FDRs or SDRs diagnosed with BrCa before the age of 60
  • Formal risk assessment shows a family history pattern that equates to 8% risk in next 10 years, or 25% lifetime risk, or 20% chance of gene mutation being harboured in the family
  • Three FDRs or SDRs diagnosed with BrCa before the age of 60
  • Two FDRs or SDRs diagnosed with BrCa befor the age of 50
  • One FDR or SDR diagnosed with OvCa at any age AND one other FDR or SDR diagnosed with OvCa at any age
  • Patient has other miscellaneous genetic risk factors
  • A faulty BrCa gene has already been identified in the family
  • Four relatives of any age

The candidate’s recommendation rule states that if any of the above arguments are true, the candidate will be recommended.

The arguments for the MEDIUM candidate are:

  • One FDR or SDR diagnosed with BrCa before 60, AND one FDR or SDR diagnosed with OVCA.
  • Formal risk assessment shows a family history pattern that equates to AT LEAST 2.6% risk in next 10 years or 17% lifetime risk
  • One FDR with bilateral BrCa where 1st primary was diagnosed before age of 50
  • One FDR female relative diagnosed with BrCa before the age of 40
  • One 1st degree male relative diagnosed with BrCa before the age of 60
  • One FDR diagnosed with BrCa before the age of 40
  • Three 1st or 2nd DRs diagnosed with BrCa
  • Two relatives diagnosed with BrCa with an average age less than 60
  • Two 1st or 2nd DRs diagnosed with BrCa, one being male and the other less than 60
  • Two 1st or 2nd DRs diagnosed with BrCa before average age of 60
  • Two SDRs before the age of 50 at diagnosis with BrCa
  • Three relatives diagnosed with BrCa at any age
  • Patient has Jewish Ashkenazi ancestry
  • Sarcoma in a relative less than 45 years
  • Complicated patterns of multiple cancers at a young age
  • Glioma or childhood adrenal carcinomas
  • Very strong paternal history

The candidate’s recommendation rule states that if any of the above arguments are true and if there is no support for the HIGH candidate, the candidate will be recommended.

An argument for the LOW candidate is that there are no risk factors. LOW is only recommended if there is no support for the other two candidates.

The Familial Genetic Risk Assessment decision has a postcondition that assigns the decision result (HIGH, MEDIUM or LOW) to a data item (patient_family_geneticRiskAssessmentResult) for later use. This data item, as well as other data items that are not requested by the process but rather used as internal variables is held in the Candidate placeholder enquiry.

  1. The Patient history plan is followed by the Patient examination enquiry. As it collects many interrelated data items, a customised page was created for this enquiry, to order the data items and enable and disable them appropriately.

  1. After reaching a decision about the patient’s level of genetic risk, the process continues with the Radiology plan, which contains the second decision: choosing the right mode of imaging for the patient, if any.

  1. The Which radiology? decision has three candidates: do a mammogram of both breasts, do an ultrasound of the affected area and do neither. The support type of this decision is numeric, meaning arguments for each candidate have different weight values. The weights of arguments for each candidate are added together and the weights of arguments against each candidate are taken away. If the resultant sum is greater than 1, then the candidate is recommended.  The do neither candidate is recommended if none of the other two candidates are recommended. As the appropriate action might be to do both a mammogram and an ultrasound, this decision enables multiple-selection of candidates.

Do a mammogram of both breasts

  1. A very strong argument for doing a mammogram of both breasts is if the assessment of the patient's latest ultrasound is U4 or U5. This argument has a weight of +500.
  2. There are several strong arguments for doing a mammogram of both breasts. Each of the following has a weight of +100:
    • The patient has been assessed as being at medium or high genetic risk and is over 30 years old
    • The clinical impression at examination was suspicious (P4 or higher)
    • The patient is over 30 and has received chest radiotherapy more than 8 years ago for Hodgkins Disease
    • The patient has had a previous breast malignancy
    • The patient has been previously diagnosed with a high risk breast lesion
  3. There are several reasonable arguments for doing a mammogram of both breasts. Each of the following has a weight of +1:
    • The clinical impression at examination was equivocal (P3)
    • The patient is under 40 and has nipple discharge which is serous sanguineous, haemo-occult positive, unilateral, single-duct or spontaneous
    • The patient has localised breast nodularity (< 3 quadrants)
    • The patient is over 40 and has nipple discharge
    • The patient has a nipple inversion with recent onset (< 6 months)
    • The patient has axillary lymph node/lump
    • The patient has skin eczema, erythema, peau d'orange, ulceration or dimpling
    • The patient has some other findings which suggest possible breast primary
    • The patient has non-cyclical breast pain
    • The patient has a palpable breast lump
  4. An argument against doing a mammogram of both breasts is if the patient is younger than 35yrs. This argument has a weight of -50.
  5. A stronger argument against doing a mammogram of both breasts is if the patient is pregnant or possibly pregnant. This argument has a weight of -400.
  6. A very strong argument against doing a mammogram of both breasts is if the patient has had a recent mammography and the result is known. This argument has a weight of -1000.

Do an ultrasound of the affected area

  1. There are several arguments in support of doing an ultrasound of the affected area. Each of the following has a weight of 1:
    • The patient has axillary lymph node/lump
    • The patient has breast implants
    • The patient has localised breast nodularity (< 3 quadrants)
    • The clinical impression at examination was not entirely benign (P3 or higher) and patient is less than 35yrs
    • The patient has a nipple inversion with recent onset (< 6months)
    • The patient has a palpable breast lump
    • The appearance of the mammography included mass lesion, asymmetric density or architectural distortion
  2. A strong argument against doing an ultrasound of the affected area is if the patient had an ultrasound recently done and the result is known. This argument was given a weight of –99.

Do neither

  1. An argument for not doing any imaging is if both the mammogram and the ultrasound candidates are not supported. This argument has a weight of 1.
  2. An argument against not doing any imaging is if both the mammogram and the ultrasound candidates are not supported overall. This argument has a weight of -1.

The Which radiology? decision has a postcondition that assigns the decision results to data items for later use. These data item are held in the Candidate placeholder enquiry.

  1. Once a decision is made, if the decision results include the ultrasound candidate, the Ultrasound result enquiry runs after the decision and collects data regarding the test results.

  1. If the decision results include the mammogram candidate, the Mammography result enquiry runs after the decision and collects data regarding the test results.

The Radiology plan has a cycling condition, which states that it should re-run either until the Neither candidate is recommended, or until both mammography and ultrasound results are known.

  1. When the cycling condition of the Radiology plan is met, the plan completes and the Biopsy plan runs. The Biopsy plan contains the third decision: choosing the right mode of biopsy for the patient, if any.

  1. The Which biopsy? decision has nine candidates, each with a different priority value:
Candidate Priority
Ultrasound guided core biopsy 1
Freehand core biopsy 2
Mammogram guided core (stereotactic) 3
Mammogram guided core (vacuum assisted) 4
Ultrasound guided FNA 5
Freehand FNA 6
Mammogram guided FNA 7
Skin biopsy 8
None 0

Priority values determine the order of a list of recommended candidates when the net support values of those candidates are equal: the smaller the priority value, the higher the location of the candidate in the list (a priority value of 0 is considered no priority, and would therefore be at the bottom of the list).

The support type of this decision is numeric: the weights of arguments for each candidate are added together and the weights of arguments against each candidate are taken away. If the resultant sum is greater than 1, then the candidate is recommended. The None candidate is recommended if none of the other candidates are recommended. As the appropriate action might be to do more than one biopsy, this decision enables multiple-selection of candidates.

Ultrasound guided core biopsy

  1. There are three arguments for doing an ultrasound guided core biopsy:
    • The latest cytology assessment was C3 or higher and the ultrasound assessment was U2 or higher. This argument has a weight of +10.
    • The patient had an ultrasound assessment of U3 or higher. This argument has a weight of +1.
    • The patient had an ultrasound assessment of U2 and they are more than 35 yrs old. This argument has a weight of +1.
  2. There are four arguments against doing an ultrasound guided core biopsy:
    • A core biopsy has already been done. This argument has a weight of -99.
    • The patient has a mammogram assessment of higher significance than the ultrasound assessment. This argument has a weight of -2.
    • The ultrasound showed a cystic appearance to the lesion. This argument has a weight of -2.
    • The ultrasound assessment was U2 and the examination assessment was low (P1 or P2) and the ultrasound appearance showed fat necrosis or lipoma or abcess. This argument has a weight of -1.

Freehand core biopsy

  1. There are two arguments for doing freehand core biopsy:
    • The latest cytology assessment was C3 or higher and the patient has a palpable lump or localised nodularity. This argument has a weight of +5.
    • The patient has a palpable lump. This argument has a weight of +1.
  2. There are three arguments against doing freehand core biopsy:
    • A core biopsy has already been done. This argument has a weight of -99.
    • The ultrasound showed a cystic appearance to the lesion. This argument has a weight of -2.
    • The ultrasound assessment was U2 and the examination assessment was low (P1 or P2) and the ultrasound appearance showed fat necrosis or lipoma or abcess. This argument has a weight of -2.

Mammogram guided core (stereotactic or vacuum assisted)

  1. There are two arguments for doing a mammogram guided core biopsy, whether stereotactic or vacuum assisted:
    • The patient had a mammogram assessment of M3 or higher. This argument has a weight of +1.
    • The latest cytology assessment was C3 or higher and the mammogram assessment was M2 or higher. This argument has a weight of +10.
  2. There are two arguments against doing a mammogram guided core biopsy, whether stereotactic or vacuum assisted:
    • A core biopsy has already been done. This argument has a weight of -99.
    • The patient has an ultrasound assessment of higher than or equal significance to the mammography assessment. This argument has a weight of -2.

Ultrasound guided FNA

  1. An argument for doing an ultrasound guided FNA is if the patient had an ultrasound assessment of U2 or U3. This argument has a weight of +1.
  2. There are three strong arguments against doing an ultrasound guided FNA. Each of the following has a weight of -99:
    • An FNA has already been done.
    • The patient has had a core biopsy.
    • The patient had a physical examination assessment (P4 or P5), ultrasound assessment (U4 or U5) or mammography assessment (M4 or M5) indicating high suspicion of cancer so core biopsy is preferred as it has higher specificity and sensitivity.
  3. There are three reasonable arguments against doing an ultrasound guided FNA. Each of the following has a weight of -2:
    • The mammography showed borderline or suspicious microcalcifications.
    • The patient has a mammogram assessment of higher significance than the ultrasound assessment.
    • Mammography showed an architectural distortion.

Freehand FNA

  1. There are three arguments for doing freehand FNA Each of the following has a weight of +1:
    • The patient has suspicious or malignant axillary lymph node/lump.
    • The patient has a palpable lump.
    • The patient has a localised nodularity.
  2. There are three strong arguments against doing freehand FNA. Each of the following has a weight of -99:
    • An FNA has already been done.
    • The patient has had a core biopsy.
    • The patient had a physical examination assessment (P4 or P5), ultrasound assessment (U4 or U5) or mammography assessment (M4 or M5) indicating high suspicion of cancer so core biopsy is preferred as it has higher specificity and sensitivity.
  3. There are two reasonable arguments against doing freehand FNA. They each have a weight of -5:
    • The mammography showed borderline or suspicious microcalcifications.
    • Mammography showed an architectural distortion.

Mammogram guided FNA

  1. An argument for doing an ultrasound guided FNA is if the patient had a mammogram assessment of M3. This argument has a weight of +1.
  2. There are three strong arguments against doing freehand FNA. Each of the following has a weight of -99:
    • An FNA has already been done.
    • The patient has had a core biopsy.
    • The patient had a physical examination assessment (P4 or P5), ultrasound assessment (U4 or U5) or mammography assessment (M4 or M5) indicating high suspicion of cancer so core biopsy is preferred as it has higher specificity and sensitivity.
  3. There are two reasonable arguments against doing freehand FNA. They each have a weight of -2:
    • The patient has an ultrasound assessment of higher than or equal significance to the mammography assessment.
    • The mammography showed borderline or suspicious microcalcifications.
    • Mammography showed an architectural distortion.

Skin biopsy

  1. An argument for doing a skin biopsy is if the patient has eczema or suspected Paget's disease. This argument has a weight of +1.
  2. A strong argument against doing a skin biopsy is if a skin biopsy has already been done. This argument has a weight of -99.
  3. An argument against doing a skin biopsy is if the patient does not have eczema or suspected Paget's disease. This argument has a weight of -1.

None

  1. An argument for not doing any biopsy is if no biopsies are recommended. This argument has a weight of +1.
  2. An argument for doing a biopsy is if one of the biopsies is recommended. This argument has a weight of -1.

  1. Once a decision is made, if the decision results include one of the FNA candidates, the Post FNA enquiry runs after the decision and collects data regarding the test results. To keep track of the fact that a FNA was preformed, the enquiry assigns a positive value to the whichBiopsyDecisionFNACandidate data item, held in the Candidate placeholder enquiry.

  1. If the decision results include the skin biopsy candidate, the Post skin biopsy action runs.To keep track of the fact that a skin biopsy was preformed, the enquiry assigns a positive value to the whichBiopsyDecisionFNACandidate data item, held in the Candidate placeholder enquiry.

  1. If the decision results include one of the core biopsy candidates, the Post core biopsy action runs.To keep track of the fact that a core biopsy was preformed, the enquiry assigns a positive value to the whichBiopsyDecisionCoreCandidate data item, held in the Candidate placeholder enquiry.

The Biopsy plan cycles either until the Which biopsy? decision result includes the None candidate, or until a FNA, a skin biopsy and a core biopsy were all performed.

  1. When the cycling condition of the Biopsy plan is met, the plan completes and the Provisional management decision at end of TA clinic decision runs; this is the final decision in this process.

The decision has five candidates:

  • Discharge patient after any necessary symptomatic treatment
  • Enter the patient into high risk follow up protocol
  • Patient to MDM with high suspicion of cancer
  • Patient to MDM with low suspicion of cancer
  • The patient is eligible for referral to geneticist

The support type of this decision is numeric: the weights of arguments for each candidate are added together and the weights of arguments against each candidate are taken away. If the resultant sum is greater than 1, then the candidate is recommended. The Discharge candidate is recommended if none of the other candidates are recommended. As the appropriate action might be to do more than one of the above, this decision enables multiple-selection of candidates.

Patient to MDM with HIGH suspicion of cancer

  • There are four arguments for referring the patient to MDM with high suspicion of cancer. Each of the following has a weight of +1:
    1. The patient had a cytology assessment of C3 or higher
    2. The patient had an examination assessment of P3 or higher
    3. The patient had a mammography assessment of M3 or higher
    4. The patient had an ultrasound assessment of U3 or higher

Patient to MDM with LOW suspicion of cancer

  • There are two arguments for referring the patient to MDM with low suspicion of cancer. Each of the following has a weight of +1:
    1. The candidate had a skin biopsy and the physical/radiological assessment was probably benign
    2. The candidate had a core biopsy and the physical/radiological assessment was probably benign
  • An argument against referring the patient to MDM with low suspicion of cancer is if referral to MDM with high suspicion is recommended. This argument has a weight of -99.

Enter the patient into high risk follow up protocol

  • There are four arguments for entering the patient into high risk follow up protocol:
    1. The patient has had a previous breast malignancy. This argument has a weight of +3.
    2. The patient has received chest radiotherapy for Hodgkins lymphoma in the past. This argument has a weight of +3.
    3. The patient has been previously diagnosed with a high-risk breast lesion. This argument has a weight of +3.
    4. The patient has been assessed as being at high genetic risk of breast cancer. This argument has a weight of +1.
  • There are two arguments against entering the patient into high risk follow up protocol:
    1. Referral to MDM with high suspicion is recommended. This argument has a weight of -99.
    2. The patient is at high genetic risk because a relative had a sarcoma at less than 45 years of age - further evaluation is required before advising surveillance. This argument has a weight of -2.

The patient is eligible for referral to geneticist

  • An argument for referring the patient to a geneticist is if the patient has been assessed as being at high genetic risk of breast cancer. This argument has a weight of +1.
  • An argument against referring the patient to a geneticist is if referral to MDM with high suspicion is recommended. This argument has a weight of -99.

Discharge patient after any necessary symptomatic treatment

  • An argument for discharging the patient is if there is no suspicion of breast cancer in this patient. This argument has a weight of +1.
  • An argument against discharging the patient is if there is reason to manage the patient rather than discharge them. This argument has a weight of -1.

 

If you have installed the Tallis Toolset, you can find this sample in the World > Samples folder in the ACL Web Repository.

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Guidelines used in the modelling of Triple Assessment:

Familial breast cancer: The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care

BASO guidelines for the surgeons in the management of symptomatic breast disease in the UK-1998 revision

NCCN Practice guideline: Breast Cancer Screening and Diagnosis

SIGN guideline

ACR Appropriateness Criteria- Appropriate imaging work-up of palpable breast masses

ACR appropriateness criteria- Appropriate imaging work-up of breast microcalcifications

ACR practice guideline for the performance of diagnostic mammography

ACR Practice guidelines for the performance of a breast ultrasound examination

ASCO 1998 surveillance guidelines

Clinical Guidelines for breast cancer screening assessment-NHSBSP Publication No 49, April 2001

Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening- NHSBSP Publication No 50, June 2001

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