I recently came across these statements:
The issues set forth herein must be further explored to ensure that patients are receiving appropriate care based on accurate diagnoses and accurate identification of predictive and prognostic markers. A pathologic diagnosis is the foundation upon which all other treatment decisions are made and with breast cancer, the pathology dictates the use of potentially curable therapy. An incorrect pathologic diagnosis may lead to negative outcomes as serious as failure to treat a missed case of breast cancer or provision of unnecessary surgery, chemotherapy, and radiation.
Concerns over the quality and practice of breast pathology are not limited to diagnostic accuracy, although many of the issues are inter-related. Other concerns relate to the training and proficiency of pathologists who are evaluating breast specimens; the lack of integration of pathologists into the clinical care team, particularly in smaller hospitals and non-hospital based pathology practices; the disconnect between reimbursement and the work required to analyze the nuances and complexities inherent in breast pathology; the impediment of patient and information flow to appropriate team members by a cumbersome healthcare infrastructure; the potential decrement in translational research as a result of privacy regulations; and a lack of mandatory uniform practice standards, which allows practice variation to occur without quantification or remedy.
This is how a white paper produced entitled “Why Current Breast Pathology Practices Must Be Evaluated” produced by Susan G. Komen for the Cure in June of 2006 started out. The next dozen pages following the executive summary provide data and personal communications and references to support their conclusions.
Fast forward nearly 10 years to March of this year when Diagnostic Concordance Among Pathologists Interpreting Breast Biopsy Specimens was published in JAMA.
That study concluded that:
3 reference pathologists agreed unanimously on the diagnosis for 75% (180 of 240) of the cases after the initial independent evaluation. Compared with the final consensus-derived reference diagnoses, overall concordance of the initial independent diagnoses of the expert panel members was 90.3% (650 of 720 interpretations).
And further concluded:
Compared with the consensus-derived reference diagnosis, the overall concordance rate of diagnostic interpretations of participating pathologists was 75.3% (5194 of 6900 interpretations). Among invasive carcinoma cases (663 interpretations), 96% were concordant, and 4% were underinterpreted; among DCIS cases (2097 interpretations), 84% were concordant, 3% were overinterpreted, and 13% were underinterpreted; among atypia cases (2070 interpretations), 48% were concordant, 17% were overinterpreted, and 35% were underinterpreted; and among benign cases without atypia (2070 interpretations), 87% were concordant and 13% were overinterpreted.
Disagreement with the reference diagnosis was statistically significantly higher among biopsies from women with higher (n = 122) vs lower (n = 118) breast density on prior mammograms (overall concordance rate, 73% for higher vs 77% for lower), and among pathologists who interpreted lower weekly case volumes or worked in smaller practices or nonacademic settings.
Much has already been made of the study design, what the participants may have been told, saw, or actually did based on public comments and the lack of the participating pathologists to perform additional sections, do extra immunohistochemical stains and perhaps even show the cases around to colleagues before rendering their opinion.
This was the study design and while perhaps not real-life, while there is high concordance for cancer (96%) and benign (87%), cases of atypical ductal hyperplasia had a much lower concordance (48%). And independent agreement between 3 experts was 75% before group review of 240 cases, raising the concordance to 90%.
Now we have some data about potential errors in diagnosis substantiating what we know about intra- and interobserver variability in pathology diagnoses, as in other areas of medicine.
During the course of my training, quality assurance programs were in place for breast, prostate and new malignancies to be reviewed by a second pathologist. I have continued to practice this way has many have and many of us have advocated for these types of departmental programs for patient safety and quality long before they became popular buzz words for “meaningful use” or “integrated healthcare”.
What is missing here though?
It seems to me organizations such as Susan G. Komen and others advocate for better patient care but pathology largely remains recognized for its faults rather than its successes.
Does pathology have patients advocating for pathology?
The white paper mentioned contained the following paragraph:
What roles should Susan G. Komen for the Cure, pathology professional societies, and the Federal government play in ensuring that breast pathology practices meet the highest possible standards in the United States?
Our challenge is to determine how to ensure that breast pathology practices are meeting or exceeding acceptable standards throughout the United States without placing undue burden on practitioners. Several professional societies are already addressing some of these issues. For example, practice guidelines, policy statements, and QC programs have been developed in an effort to standardize and improve breast pathology practice. Nonetheless, concerns remain regarding the adequacy of specimen handling, pathology reporting, laboratory testing, personnel training, and quality control. The sufficiency of current practice guidelines must be examined to determine whether additional guidelines are needed and whether the use of such guidelines should be mandated. Komen for the Cure stands ready to work with the appropriate parties to address the important issues raised herein.
Has this really ever happened?
Have patient advocacy groups ever championed ensuring best (or breast) pathology practices are being supported without “placing undue burden on practioners” such as, perhaps, pathologists doing more for less with an impetus for quantity over quality with declining reimbursements, increased expenses and more regulation. I think this would constitute “placing undue burden on practioners”.
Have we partnered with patient advocacy groups to represent pathology and laboratories on behalf of themselves?
Has a patient ever told a hospital administrator “These physicians provide the life-saving diagnoses that tell my surgeon, oncologist and radiation oncologist the diagnosis to treat my disease. I understand they need more pathologists or histotechnologists or training or space or updated equipment or information systems or improved communications between other providers and laboratories to treat patients like me.”
I think we know the answer to this question. And it’s our own fault.
We as a community and as a medical specialty need to change this.
Link to White Paper mentioned.