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  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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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 visitIV
• Appropriate use of preoperative mammographic evaluationIV
• Appropriate use of imaging &/or cytology or needle biopsy, if required, to be performed at the initial visitIV
• Appropriate use of preoperative diagnosis by fine-needle aspiration cytology, needle histology or biopsyIV
• 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 ultrasoundIV
• 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 visitIV
• Quality of fine-needle aspiration samples from lesions, which subsequently prove to be breast cancer, should be adequate as deemed by the breast pathologistIV
1.2 Surgical procedures
• Appropriate use: A biopsy should be performed within 6 weeks if fine-needle aspiration cannot rule out malignancyIV
• Appropriate use of first localization biopsy operation to correctly identify impalpable lesionsIV
• Quality of breast biopsy: primary operable breast cancer receives a frozen sectionIV
• Quality of technique to determine histological node status for all invasive tumors, either by sampling or clearanceIV
• Quality of sampling nodes for invasive breast cancer, to include ≥ 4 nodesIV
• Quality of hormone receptor assayIV
1.3 QOL and patient satisfaction relating to diagnosis
• Change in QOL after diagnosis of breast cancerIac
• Women reporting an overall satisfaction with the quality of breast careIac
1.4 General category
• Appropriate use of referrals to surgeon by general practitioner according to breast referral guidelinesIV
• >90% of women with breast cancer detected by screening should attend an assessment center within 3 weeks of mammographyIV
• Patients attending for diagnostic purposes seen on at least 1 occasion by a breast specialist surgeonIV
• <10% of all new cases of women with breast cancer should attend the clinic/hospital on > 2 occasions for diagnostic purposesIV
• Urgent referrals of women with breast cancer to be seen within 5 working daysIV
• Women with breast cancer to be seen by specialist in timely fashion post referral for diagnostic purposesIV
• Management of cases coming to surgery from the screening program carried out by surgeons who have acquired the necessary specialist knowledgeIV
• ≥90% of women requiring an operation for diagnostic purposes should be admitted within 14 days of the surgical decisionIV
• ≥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 diagnosisIV
• Appropriate use of an evaluation in compliance with guidelinesIV
• Appropriate use of initial examinationIV
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 presentIV
• Appropriate use of all surgeryIV
• No breast-conserving surgery or mastectomy in metastatic diseaseIV
• Appropriate use of breast-conserving surgeryIV
• Appropriate number of therapeutic operations (≤ 2) for women having breast-conserving surgeryIV
• Appropriate use of mastectomyIV
• Appropriate use of axillary lymph node dissectionIV
2.2 Radiotherapy
• Appropriate use of radiotherapyIV
• 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 treatmentIV
• Appropriate use of radiotherapy after breast-conserving surgeryIV
• Quality of radiotherapy after breast-conserving surgery (following guidelines)IV
• Appropriate use of radiotherapy after mastectomyIV
• Quality of radiotherapy via planning on a dedicated simulatorIV
• Quality of radiotherapy: done 5 days/weekIV
• Quality of radiotherapy: homogenous dose distribution of radiotherapyIV
• Quality of radiotherapy: use of wedges on tangent breast fieldsIV
• 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 breastIV
• Appropriate use of palliative radiotherapy for women with progression or recurrenceIV
• Regional recurrence needing further surgery or radiotherapyIV
• Quality of radiotherapy: both tangent fields treated dailyIV
• Quality of radiotherapy: receiving 4,500–5,000 cGy total breast dose given in 180–200 cGy fractionsIV
• Quality of radiotherapy: electron beam breast radiation usedIV
2.3 Adjuvant systemic therapy
• Appropriate use of any adjuvant systemic therapyIV
• 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 cancerIV
• Appropriate use of any adjuvant systemic therapy in women with node (-) breast cancerIV
• Appropriate use of adjuvant systemic therapy after breast-conserving surgeryIV
• Appropriate use of tamoxifenIV
• Appropriate use of tamoxifen in premenopausal women with node (-), intermediate risk, breast cancerIV
• Appropriate use of tamoxifen in postmenopausal women with node (-), intermediate risk, breast cancerIV
• Appropriate use of tamoxifen in postmenopausal women with node (-), high risk, estrogen receptor (+), breast cancerIV
• 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 cancerIV
• Appropriate use of chemotherapyIV
• Appropriate use of chemotherapy in women with node (-), high risk, estrogen receptor (-), breast cancerIV
• Appropriate use of chemotherapy in women with node (-), estrogen receptor (+), breast cancerIV
• Appropriate use of chemotherapy in premenopausal women with node (-), high risk, estrogen receptor (+), breast cancerIV
• Appropriate use of chemotherapy in premenopausal women with node (+), estrogen receptor (-), breast cancerIV
• Appropriate use of chemotherapy in postmenopausal women with node (+), estrogen receptor (-), breast cancerIV
• Appropriate use of chemotherapy in postmenopausal women with node (+), estrogen receptor (+), breast cancerIV
• Appropriate use of chemotherapy in women <50 years of age with node (+), breast cancerIV
• Appropriate use of chemotherapy &/or ovarian ablation in premenopausal women with node (+), estrogen receptor (+), breast cancerIV
• Appropriate decision not to provide adjuvant systemic therapy for women node (-), low risk, breast cancerIV
• Appropriate decision not to provide adjuvant systemic therapy for women > 65 years of age with high risk, estrogen receptor (-), breast cancerIV
• Quality of chemotherapy: proper doses administered (≥ 85% dose intensity [DI] & relative dose intensity [RDI]) of CMFIV
• Availability of office procedure manual used for chemotherapy administrationIV
2.4 QOL and patient satisfaction relating to treatment
• Overall changes in QOL over time, before & after radiotherapyIac
• Change in QOL in women with metastatic breast cancerIac
• Women with a significant improvement in QOL in clinical phases of breast cancerIac
• Change in QOL by time and treatment arm in postmenopausal, node (-) breast cancer women who underwent adjuvant therapyIa
• Change in QOL over timeIac
• Satisfaction of women with breast cancer with the treatment choiceIac
• Participation of women with breast cancer in decision-making as much as they wantedIV
• Received enough information about surgery and radiotherapyIV
2.5 General category
• Board certified medical doctors in medical oncologyIV
• Documentation of Continuing Medical Education credits for the 2 years preceding auditIV
• Referral to oncologist for treatmentIV
• Women with breast cancer given the opportunity to see a breast cancer specialist nurseIV
• Evidence of discussion about surgical optionsIV
• ≥90% of women admitted for an operation within 21 days of the surgical decision to operate for therapeutic purposesIV
• 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 failureIV
• 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 metastasesIV
3. Followup
• Appropriate use: Women with a history of breast cancer should have a yearly mammographyIV
• Appropriate use of guidelines for followup surveillance of breast cancerIV
• Women with breast cancer developing local recurrence within 5 years after breast-conserving surgeryIV
• Women with breast cancer developing local recurrence within 5 years after mastectomyIV
• Appropriate use of prophylactic radiotherapy in women with high risk of flap recurrenceIV
4. REPORTING/DOCUMENTATION
4.1 Pathology reporting/documentation
• Reporting gross observation of lesionIV
• 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 carcinomaIV
• Reporting assessment of microscopic marginsIV
• Reporting carcinoma confirmed microscopicallyIV
• 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 chartIV
4.2 Imaging reporting/documentation
• Size of mammographic abnormalityIV
4.3 Chemotherapy reporting/documentation
• Presence of chemotherapy flow sheets in active treatment chartsIV
• Presence of body surface area calculations on chemotherapy flow sheetsIV

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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