Appendix G. Listing of Quality Indicators

Howard M Schachter; Vasil Mamaladze; Gabriela Lewin; Larry Paszat; Shailendra Verma; Cathy DeGrasse; Ian Graham; Melissa Brouwers; Margaret Sampson; Andra Morrison; Li Zhang; Peter O'Blenis; Chantelle Garrity

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Schachter HM, Mamaladze V, Lewin G, et al. Measuring the Quality of Breast Cancer Care in Women. Rockville (MD): Agency for Healthcare Research and Quality (US); 2004 Oct. (Evidence Reports/Technology Assessments, No. 105.)

This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Measuring the Quality of Breast Cancer Care in Women.

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Appendix G. Listing of Quality Indicators

Listing of Quality Indicators Used to Measure Adherence to Standards of Breast Cancer Care

1. DIAGNOSIS

1.1 Preoperative diagnosis

• Appropriate use: If a palpable breast mass has been detected, at least one of the following procedures should be completed within 3 months: fine-needle aspiration, mammography, ultrasound, biopsy and/or a followup visit^IV

• Appropriate use of preoperative mammographic evaluation^IV

• Appropriate use of imaging &/or cytology or needle biopsy, if required, to be performed at the initial visit^IV

• Appropriate use of preoperative diagnosis by fine-needle aspiration cytology, needle histology or biopsy^IV

• Appropriate use: A biopsy or fine-needle aspiration should be performed within 6 weeks either when the mammography suggests malignancy or the persistent palpable mass is not cystic on ultrasound^IV

• Appropriate use: If a breast mass has been detected on two separate occasions, then either a biopsy, fine-needle aspiration or ultrasound should be performed within 3 months of the second visit^IV

• Quality of fine-needle aspiration samples from lesions, which subsequently prove to be breast cancer, should be adequate as deemed by the breast pathologist^IV

1.2 Surgical procedures

• Appropriate use: A biopsy should be performed within 6 weeks if fine-needle aspiration cannot rule out malignancy^IV

• Appropriate use of first localization biopsy operation to correctly identify impalpable lesions^IV

• Quality of breast biopsy: primary operable breast cancer receives a frozen section^IV

• Quality of technique to determine histological node status for all invasive tumors, either by sampling or clearance^IV

• Quality of sampling nodes for invasive breast cancer, to include ≥ 4 nodes^IV

• Quality of hormone receptor assay^IV

1.3 QOL and patient satisfaction relating to diagnosis

• Change in QOL after diagnosis of breast cancer^Iac

• Women reporting an overall satisfaction with the quality of breast care^Iac

1.4 General category

• Appropriate use of referrals to surgeon by general practitioner according to breast referral guidelines^IV

• >90% of women with breast cancer detected by screening should attend an assessment center within 3 weeks of mammography^IV

• Patients attending for diagnostic purposes seen on at least 1 occasion by a breast specialist surgeon^IV

• <10% of all new cases of women with breast cancer should attend the clinic/hospital on > 2 occasions for diagnostic purposes^IV

• Urgent referrals of women with breast cancer to be seen within 5 working days^IV

• Women with breast cancer to be seen by specialist in timely fashion post referral for diagnostic purposes^IV

• Management of cases coming to surgery from the screening program carried out by surgeons who have acquired the necessary specialist knowledge^IV

• ≥90% of women requiring an operation for diagnostic purposes should be admitted within 14 days of the surgical decision^IV

• ≥90% of women with breast cancer or with an abnormality requiring diagnostic operation need to be told of this within 5 working days of investigations leading to this diagnosis^IV

• Appropriate use of an evaluation in compliance with guidelines^IV

• Appropriate use of initial examination^IV

2. TREATMENT

2.1 Surgery

• Appropriate use: Women with stage I or stage II breast cancer should be offered a choice of modified radical mastectomy or breast-conserving surgery, unless contraindications to breast-conserving surgery are present^IV

• Appropriate use of all surgery^IV

• No breast-conserving surgery or mastectomy in metastatic disease^IV

• Appropriate use of breast-conserving surgery^IV

• Appropriate number of therapeutic operations (≤ 2) for women having breast-conserving surgery^IV

• Appropriate use of mastectomy^IV

• Appropriate use of axillary lymph node dissection^IV

2.2 Radiotherapy

• Appropriate use of radiotherapy^IV

• Appropriate use: Women treated with breast-conserving surgery should begin radiation therapy within 6 weeks of completing either of the following: the last surgical procedure on the breast (including reconstructive surgery that occurs within 6 weeks of primary resection) or chemotherapy, if patient receives adjuvant chemotherapy, unless wound complications prevent the initiation of treatment^IV

• Appropriate use of radiotherapy after breast-conserving surgery^IV

• Quality of radiotherapy after breast-conserving surgery (following guidelines)^IV

• Appropriate use of radiotherapy after mastectomy^IV

• Quality of radiotherapy via planning on a dedicated simulator^IV

• Quality of radiotherapy: done 5 days/week^IV

• Quality of radiotherapy: homogenous dose distribution of radiotherapy^IV

• Quality of radiotherapy: use of wedges on tangent breast fields^IV

• Appropriate use of radiotherapy on axilla following axillary lymph node dissection, to deal with increased risk of local recurrence (i.e. extracapsular extension; ≥ 4 positive nodes)^IV

• Appropriate use of parasternal radiotherapy for tumors located in the medial part of breast^IV

• Appropriate use of palliative radiotherapy for women with progression or recurrence^IV

• Regional recurrence needing further surgery or radiotherapy^IV

• Quality of radiotherapy: both tangent fields treated daily^IV

• Quality of radiotherapy: receiving 4,500–5,000 cGy total breast dose given in 180–200 cGy fractions^IV

• Quality of radiotherapy: electron beam breast radiation used^IV

2.3 Adjuvant systemic therapy

• Appropriate use of any adjuvant systemic therapy^IV

• Appropriate use: Women with invasive breast cancer that is node-positive, or node-negative and primary tumor ≥ 1 cm, should be treated with adjuvant systemic therapy to include combination chemotherapy (and/or tamoxifen, 20mg/d) ^IV

• Appropriate use of any adjuvant systemic therapy in women with node (+) breast cancer^IV

• Appropriate use of any adjuvant systemic therapy in women with node (-) breast cancer^IV

• Appropriate use of adjuvant systemic therapy after breast-conserving surgery^IV

• Appropriate use of tamoxifen^IV

• Appropriate use of tamoxifen in premenopausal women with node (-), intermediate risk, breast cancer^IV

• Appropriate use of tamoxifen in postmenopausal women with node (-), intermediate risk, breast cancer^IV

• Appropriate use of tamoxifen in postmenopausal women with node (-), high risk, estrogen receptor (+), breast cancer^IV

• Appropriate use of tamoxifen in postmenopausal women with node (+)^IV

• Appropriate use of chemotherapy and hormone therapy (tamoxifen)^IV

• Appropriate use of chemotherapy and hormone therapy (tamoxifen) in premenopausal women, node (+), hormone receptor (+), breast cancer^IV

• Appropriate use of chemotherapy^IV

• Appropriate use of chemotherapy in women with node (-), high risk, estrogen receptor (-), breast cancer^IV

• Appropriate use of chemotherapy in women with node (-), estrogen receptor (+), breast cancer^IV

• Appropriate use of chemotherapy in premenopausal women with node (-), high risk, estrogen receptor (+), breast cancer^IV

• Appropriate use of chemotherapy in premenopausal women with node (+), estrogen receptor (-), breast cancer^IV

• Appropriate use of chemotherapy in postmenopausal women with node (+), estrogen receptor (-), breast cancer^IV

• Appropriate use of chemotherapy in postmenopausal women with node (+), estrogen receptor (+), breast cancer^IV

• Appropriate use of chemotherapy in women <50 years of age with node (+), breast cancer^IV

• Appropriate use of chemotherapy &/or ovarian ablation in premenopausal women with node (+), estrogen receptor (+), breast cancer^IV

• Appropriate decision not to provide adjuvant systemic therapy for women node (-), low risk, breast cancer^IV

• Appropriate decision not to provide adjuvant systemic therapy for women > 65 years of age with high risk, estrogen receptor (-), breast cancer^IV

• Quality of chemotherapy: proper doses administered (≥ 85% dose intensity [DI] & relative dose intensity [RDI]) of CMF^IV

• Availability of office procedure manual used for chemotherapy administration^IV

2.4 QOL and patient satisfaction relating to treatment

• Overall changes in QOL over time, before & after radiotherapy^Iac

• Change in QOL in women with metastatic breast cancer^Iac

• Women with a significant improvement in QOL in clinical phases of breast cancer^Iac

• Change in QOL by time and treatment arm in postmenopausal, node (-) breast cancer women who underwent adjuvant therapy^Ia

• Change in QOL over time^Iac

• Satisfaction of women with breast cancer with the treatment choice^Iac

• Participation of women with breast cancer in decision-making as much as they wanted^IV

• Received enough information about surgery and radiotherapy^IV

2.5 General category

• Board certified medical doctors in medical oncology^IV

• Documentation of Continuing Medical Education credits for the 2 years preceding audit^IV

• Referral to oncologist for treatment^IV

• Women with breast cancer given the opportunity to see a breast cancer specialist nurse^IV

• Evidence of discussion about surgical options^IV

• ≥90% of women admitted for an operation within 21 days of the surgical decision to operate for therapeutic purposes^IV

• Appropriate use of treatment sequences according to guidelines (including surgery; radiotherapy; chemotherapy; hormone therapy; initial examination; and followup)^IV

• Appropriate use of definitive locoregional therapy (total mastectomy + axillary lymph node dissection, or, breast-conserving surgery + axillary lymph node dissection + radiotherapy)^IV

• Appropriate use of alternative definitive therapy (radiotherapy after breast-conserving surgery + axillary lymph node dissection or adjuvant treatment)^IV

• Cases not receiving recommended treatment (radiotherapy after breast-conserving surgery or systemic therapy) due to system failure^IV

• Appropriate use: Women with metastatic breast cancer should be offered hormonal therapy, chemotherapy, and/or enrollment in a clinical trial with documentation of informed consent within 6 weeks of the identification of metastases^IV

3. Followup

• Appropriate use: Women with a history of breast cancer should have a yearly mammography^IV

• Appropriate use of guidelines for followup surveillance of breast cancer^IV

• Women with breast cancer developing local recurrence within 5 years after breast-conserving surgery^IV

• Women with breast cancer developing local recurrence within 5 years after mastectomy^IV

• Appropriate use of prophylactic radiotherapy in women with high risk of flap recurrence^IV

4. REPORTING/DOCUMENTATION

4.1 Pathology reporting/documentation

• Reporting gross observation of lesion^IV

• Reporting verification tumor size (microscopic)^IV

• Reporting number of positive lymph nodes (microscopic)^IV

• Reporting nuclear grade (microscopic)^IV

• Reporting mitotic rate (microscopic)^IV

• Reporting extent of tubule formation (microscopic)^IV

• Reporting laterality of surgical specimen (gross examination)^IV

• Reporting identification of affected quadrant (gross examination)^IV

• Reporting the orientation of the pathology specimen (gross examination)^IV

• Reporting size of specimen (gross examination)^IV

• Reporting tumor size (macroscopic)^IV

• Reporting tumor size (microscopic)^IV

• Reporting lymph node presence/absence (gross examination)^IV

• Reporting number of lymph nodes present (gross examination)^IV

• Reporting nature of specimen (gross examination)^IV

• Reporting distance of tumor from nipple (gross examination)^IV

• Reporting description of cut surface of the tumor (gross examination)^IV

• Reporting description of skin (gross examination)^IV

• Reporting size of overlying skin (gross examination)^IV

• Reporting description of nipple (gross examination)^IV

• Reporting presence or absence of fascia or skeletal muscle (gross examination) ^IV

• Reporting involvement of apical lymph nodes (microscopic)^IV

• Reporting size of concurrent ductal carcinoma in situ (microscopic)^IV

• Reporting description of background breast (microscopic)^IV

• Reporting ductal carcinoma in situ (DCIS) present/absent (microscopic)^IV

• Reporting measurement of macroscopic margins of carcinoma^IV

• Reporting assessment of microscopic margins^IV

• Reporting carcinoma confirmed microscopically^IV

• Reporting histological type (microscopic)^IV

• Reporting histological grade (microscopic)^IV

• Reporting lymph-vascular invasion (microscopic)^IV

• Reporting size of invasive carcinoma (microscopic)^IV

• Reporting estrogen receptor status (microscopic)^IV

• Reporting progesterone receptor status (microscopic)^IV

• Reporting specimen inked (microscopic) ^IV

• Reporting Bloom Scarf Richardson scale (tumor grade) (microscopic)^IV

• Reporting TNM staging (microscopic)^IV

• Reporting distance to the closest margin (microscopic)^IV

• Reporting pathological extent of primary tumor (microscopic)^IV

• Reporting having performed flow cytometry (microscopic)^IV

• Reporting cytometry ploidy (microscopic)^IV

• Pathology reports on chart^IV

4.2 Imaging reporting/documentation

• Size of mammographic abnormality^IV

4.3 Chemotherapy reporting/documentation

• Presence of chemotherapy flow sheets in active treatment charts^IV

• Presence of body surface area calculations on chemotherapy flow sheets^IV

: Level Ia = pre-study data indicating consistently sound psychometric properties; Iac = pre- and on-study data indicating consistently sound psychometric properties; IV = no pre- or on-study psychometric data

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Schachter HM, Mamaladze V, Lewin G, et al. Measuring the Quality of Breast Cancer Care in Women. Rockville (MD): Agency for Healthcare Research and Quality (US); 2004 Oct. (Evidence Reports/Technology Assessments, No. 105.) Appendix G. Listing of Quality Indicators.

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Appendix G. Listing of Quality Indicators - Measuring the Quality of Breast Cancer Care in Women
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Measuring the Quality of Breast Cancer Care in Women.

Appendix G. Listing of Quality Indicators

Listing of Quality Indicators Used to Measure Adherence to Standards of Breast Cancer Care

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