Reliability of Medical Records in Identifying Inflammatory Breast Cancer and Locally Advanced Breast Cancer in a Case-Control study in North Africa
Inflammatory breast cancer (IBC) is a relatively rare but aggressive form of breast cancer, which accounts for 1-2% of all breast cancers in the United States (1). In North Africa reports from various studies have indicated the proportion of IBC out of all breast cancer cases ranges from 5-7% in Tunisia to 10% in Egypt (2) (3).
IBC is a subset of locally advanced breast cancer (LABC) (4). According to the American Joint Committee on Cancer (AJCC), it is defined as a clinical-pathologic entity characterized by diffuse erythema and edema (peau d'orange) involving one-third or more of the skin of the breast, with tumor stage T4d (5). Typically these symptoms have a rapid onset. The diagnosis is primarily clinical, but pathologic confirmation of invasive carcinoma in addition to clinical findings is required.
It is unknown whether the signs/symptoms and stage designations required for a diagnosis of IBC and its’ differentiation from other types of LABC are routinely recorded in hospital medical records. The proposed study will assess how IBC cases and the subset of other LABC cases that would be classified as T4b or T4c are recorded and differentiated from each other in medical records. We will use data and infrastructure from an ongoing case-control study of IBC in North Africa, in which IBC cases were identified by clinicians at the time of diagnosis, not from medical records.
OBJECTIVES AND SPECIFIC AIMS:
The main objective of this project is to investigate the reliability of medical records for identifying IBC cases in six hospitals in Egypt, Morocco, and Tunisia. Specifically this study aims to determine: 1) the proportion of IBC cases enrolled in an on-going case-control study that had a diagnosis of IBC recorded in the medical record (ie. T4d or the words “IBC”); 2) the proportion of IBC cases enrolled in the case-control study that had signs and symptoms of IBC (redness, edema, peau d’orange) and their extent and duration recorded in hospital medical records; 3) the proportion of non-IBC LABC with any redness, edema, or peau d’orange upon clinical examination that had a stage diagnosis designating non-IBC LABC in the medical record (ie. T4b, T4c); 4) the proportion of non-IBC LABC with any redness, edema, and peau d’orange upon clinical examination that had these signs/symptoms and their duration and extent recorded in the medical records; 5) whether these proportions differ by study site.
Successful completion of this study will help determine whether medical record review at study hospitals can be used to identify IBC cases and adequately distinguish them from other types of LABC cases. This information could be useful in 1) planning new epidemiologic or clinical studies; 2) determining whether medical record review can serve as a quality control procedure to ascertain completeness of case enrollment at diagnosis, and; 3) quantifying the need for educational programs for physicians if diagnosis and signs and symptoms of IBC are not properly recorded.
This study will involve IBC cases enrolled in an on-going case-control study developed by the University of Michigan and NCI-USA. The case-control study is being conducted at the major cancer center in Tunisia (Institut Salah Azaiz), three major cancer centers in Egypt (NCI-Cairo, the Gharbiah Cancer Society, and the Tanta Cancer Center), and two major cancer centers in Morocco (Le Centre D’Oncologie Ibn Rochd in Casablanca, Morocco and the University of Marrakech).
Non-IBC LABC cases are not being recruited as part of the case-control study of IBC. However, approximately five cases initially thought to be IBC, but later determined to be other types of LABC, have been identified in the case-control study at the NCI-Cairo and will be included in the proposed study.
Additionally, non-IBC LABC cases that display any redness, edema, or peau d’orange will be enrolled by collaborating physicians at the study hospitals. They will complete a clinical examination form similar to that completed in the case-control study, obtain digital photographs of the breasts, and copy medical records. The same number of non-IBC LABC cases as IBC cases at each center will be enrolled in the proposed study.
Standard chi-square tests will be used to analyze differences in proportions of information recorded by study hospital.
(1) Anderson WF, Schairer C, Chen BE, Hance KW, Levine PH. Epidemiology of inflammatory breast cancer (IBC). Breast Dis. 2005-2006;22:9-23.
(2) Boussen H, Bouzaiene H, Ben Hassouna J, Gamoudi A, Benna F, Rahal K. Inflammatory breast cancer in Tunisia: reassessment of incidence and clinicopathological features. Semin Oncol. 2008 Feb;35(1):17-24.
(3) An-Chi Lo, Ageliki Georgopoulos, Celina G. Kleer, Mousumi Banerjee, Sherif Omar, Hussein Khaled, Saad Eissa, Ahmed Hablas, Hoda G. Omar, Julie A. Douglas, Sofia D. Merajver, and Amr S. Soliman. Analysis of RhoC expression and lymphovascular emboli in inflammatory vs non-inflammatory breast cancers in Egyptian patients. Breast. 2009 Feb;18(1):55-9. Epub 2009 Jan 20.
(4) William F. Anderson, Kenneth C. Chu, and Shine Chang. Inflammatory Breast Carcinoma and Noninflammatory Locally Advanced Breast Carcinoma: Distinct Clinicopathologic Entities?J Clin Oncol. 2003; 21:2254-2259.
(5) American Joint Committee on Cancer Staging Manual, 7th, Edge SB, Byrd DR, Compton CC, et al (Eds), Springer, New York 2010.
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