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The Sister Study

breast cancer Validation

Confirmation of Breast Cancer Diagnosis

Self-reports are the main source of initial information collected on breast cancer and other health conditions in the Sister Study. Participants who develop breast cancer report their diagnosis through telephone calls, e-mails, correspondence with the Sister Study Helpdesk, or regularly scheduled follow-ups (Annual Health Updates or Detailed Follow-Up Questionnaires). Once a study participant reports a breast cancer diagnosis, she is asked to provide a copy of her pathology report, if available.

Approximately six months after the reported date of diagnosis, participants are asked to complete a brief questionnaire (Breast Cancer Follow-Up Form, BCFF) and to permit contact of their health care provider for retrieval of relevant medical records and pathology reports. Medical records are abstracted onto standard forms (Breast Cancer Medical Report Form, and when applicable, Stage IV Breast Cancer Medical Report Form) to verify self-reported breast cancer diagnosis information, collect information needed for staging, and obtain additional diagnostic information. Information abstracted includes:

  • Tumor characteristics
  • Hormone receptor status
  • Lymph node involvement
  • Metastasis
  • Treatments (surgery, chemotherapy, radiation, biological therapy, hormonal treatment, clinical trial enrollment)
  • Genetic testing

Concordance of Self-Reported and Medical Record-Abstracted Breast Cancer Characteristics

Data Release Timeline: DR 6.0:
(Requires Adobe Acrobat - Download Here) exit disclaimer

Links to other Data Releases, including detailed analysis of concordance in DR 4.0

Data shown are for incident breast cancer events confirmed by medical records (N = 2,324), which are 81.1% of the total incident breast cancer events (N=2,865) as of Data Release 5.0.*

As of Data Release 5.0, the Sister Study has medical records for 81.1% of women who reported a breast cancer diagnosis. Among women with medical records retrieved, the positive predictive value (PPV) of a self-reported breast cancer is 99.4%. PPVs for self-reported invasiveness, ductal or lobular origin, and hormone receptor characteristics can be found below.

Self-Reported Type for any Breast Cancer (Overall) and by Invasiveness % Confirmed by Medical Records (PPV)

Breast Cancer

99.4%

Invasive (any)

Invasive-Ductal (any)†‡
   Invasive-Ductal (only)†‡
Invasive-Lobular (any)†‡
   Invasive-Lobular (only)†‡
Invasive- Both Ductal/Lobular or Mixed†‡

99.3%

98.5%
96.3%
73.4%
73.1%
43.8%

In Situ (only)

In Situ-Ductal or Both Ductal/Lobular‡
   In Situ-Ductal (only)‡
In Situ-Lobular

64.9%

67.7%
67.8%
68.2%

 

Self-Reported Type by Ductal or Lobular Origin†‡ % Confirmed by Medical Records (PPV)

Ductal (Any)

Ductal-Only

98.8%

96.4%

Both Ductal/Lobular or Mixed

39.0%

Lobular (Any)

Lobular-Only

72.2%

75.8%

Excludes n = 5 cases not of ductal or lobular origin (phyllodes tumors).
Special subtypes of inflammatory or Paget’s were assigned accordingly to ductal or lobular categories. 

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Hormone Receptor Characteristics among those with Medically Confirmed Invasive Cancers

[Excludes those that did not complete Breast Cancer Follow-Up Form (asks about self-report of hormone receptor characteristics) or are missing hormone receptor data in medical records].

Self-Reported Hormone Receptor Status % Confirmed by Medical Records (PPV)

Estrogen Receptor (ER)

Positive
Negative

 

99.3%
83.1%

Progesterone Receptor (PR)

Positive
Negative

 

99.0%
71.3%

Human Epidermal Growth Factor Receptor 2 (HER2)

Positive
Negative

 

64.3%
99.0%

*Further excluded 2 women from concordance results who have medical confirmation of breast cancer but disavowed (refuted) their original self-report of breast cancer.

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Other Data Releases:

Breast Cancer Validation: Data Release 3

Breast Cancer Validation: Data Release 4

For more information on concordance between breast cancer self-report and medical record(s) (DR 4.0):

For full text (citation above), please see the link below. Note: Manuscript pdfs are not 508 compliant however, compliant versions can be obtained from the respective journals, accessed via the link in the citation.

Breast Cancer Validation: Data Release 5


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