In 2012, more than 200,000 women in the United States were diagnosed with invasive breast cancer. Despite the high incidence, 5-year curative rates for early-stage cancer exceed 85%, reflecting remarkable progress over the past 3 decades in tailoring antineoplastic approaches.1 One such advancement is identification of a breast cancer biomarker profile for all cancers, which results from regular testing of hormone receptors alongside other predictive and prognostic markers. In combination with patient characteristics, these profiles ensure that targeted therapies are selectively applied in delivering patient-centered care. A shining example of this has been the incorporation of trastuzumab for cancers that overexpress HER2, the use of which has dramatically extended survival in both the adjuvant2 and metastatic settings.3
Breast cancer biomarker ordering and measurement are guided by several national recommendations of best practice based on clinical and pathologic scenarios.4,5 These guidelines also highlight when testing may not be appropriate, such as when unnecessary confirmatory measures are ordered to validate a previously positive test. Especially in situations in which additional information rarely changes the clinical approach, systematic evaluations of the frequency of such “low value” practices should routinely occur. Quality improvement interventions can then be designed and tested in local organizations to identify solutions that simultaneously support both patient-centered and resource-efficient care.
Using the Standards for Quality Improvement Reporting Excellence (SQUIRE) framework,6 this article describes a directed quality improvement project to address ordering variance of HER2 testing at the Duke Cancer Institute (DCI). Pilot data demonstrated special cause variance in practice that was not easily attributable to patient- or disease-related causes. The team at DCI planned to target this to reach the following specified stated aims statement:
Over the next 2 years, the multidisciplinary breast program at the DCI will establish standardized practices for biomarker ordering, receipt, and interpretation that apply to 90% of early-stage breast cancer patients.
The authors would like to acknowledge the contributions of Donald Kirkendall, ELS, for his excellent feedback on the development of the manuscript.
The authors have have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors. The authors would like to recognize generous funding from the NCCN Opportunity for Improvement in Breast Cancer grant awarded to Duke Cancer Institute.
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