In this study of 102 women who presented with a diagnostic delay of at least 90 days or at least stage II breast cancer, we found that process of care failures affected about one in four patients. Process breakdowns spanned all phases of the breast care process. About half were attributable to clinicians and their practices, delaying diagnosis by approximately 3 weeks; the remaining breakdowns were related to patients’ failure to seek care for initial symptoms in a timely manner or to follow through on recommended screenings or diagnostic tests, resulting in a median delay of more than 4 months. In the multivariate analysis, process failures were more likely when the primary care clinician was male and when the patient was non-white. Since this study was not based on malpractice claims data, it provides insight into how often patient factors, as well as failures in the medical system, contribute to a delayed diagnosis of breast cancer.
Our results inform and extend malpractice claims-based studies that document multiple deficiencies in the diagnostic process. Process failures in our study affected about one-quarter of patients, similar to the 29 percent reported in a malpractice claims study10
. We also found that patients often experienced multiple process failures of varying types, corroborating findings from emergency department and ambulatory studies suggesting that the majority of medical errors involve two or more process breakdowns2,6
Our study also substantiated findings demonstrating disparities in the breast care process associated with clinician gender11–13
. While the benefits of self breast exams and clinical breast exams are controversial14
, Lurie and colleagues showed that female physicians are more likely to talk with patients about breast cancer prevention, to believe in the effectiveness of mammography, and to feel comfortable performing clinical breast examinations13
. Males, on the other hand, may have a tendency to defer breast examinations to nurse practitioners or OB/GYN physicians.
In contrast to previous work, our study identified patient behavior as a prominent component of process failures2,6
. In 20 of 26 cases (77%), patients’ behavior contributed, at least in part, to suboptimal breast cancer care. This occurred when patients discovered findings at home but did not report them in a timely manner, or when they failed to complete recommended mammograms or adhere to their providers’ suggested follow-up plan.
How should we understand patients’ contributions to diagnostic errors in breast care? Denial may cause some patients to delay seeking treatment for suspicious symptoms or to fail to follow up on physician recommendations15,16
. In addition, process failures in our study were more common among non-whites and Medicaid recipients, indicating a sociodemographic linkage that may be mediated by poor health literacy or practical obstacles17–24
. For some patients, failure to report a breast lump or to adhere to a physician’s recommendation may indicate a lack of understanding of the significance of the finding or the urgency of the recommendation. Other patients may face financial constraints, transportation difficulties, or language barriers that could affect a patient’s decision to delay seeking care, as suggested by a study of low income women in Los Angeles23
Do diagnostic delays affect clinical outcomes? The evidence seems to suggest that patient delay (defined in most studies as the duration between onset of symptoms and the first medical consultation) is associated with worse prognosis, whereas provider delay (defined as duration between first consultation and biopsy or start of treatment) is either neutral25–27
. Afzelius and colleagues found that patient delays of >60 days resulted in poorer outcomes compared to short delays (0–14 days)28
, and in a population-based study of 287 German women, Arndt and colleagues found that patient delay (categorized as <1 month, 1–3 months, and >3 months) was positively correlated with stage at diagnosis for poorly differentiated tumors (p
. In contrast, provider delays of 3 months or more were not associated with decreased survival in several studies25–28
, perhaps because indolent tumors were more likely to be diagnosed late.
Our findings therefore offer several implications for clinical care. To address practice-level process failures, clinicians and practice administrators must ensure that mechanisms are in place to coordinate diagnostic screenings among multiple providers, to facilitate the follow-up and communication of critical test results, and to direct the implementation of appropriate care plans. To that end, several “best practices” have been developed encouraging the use of information technology to help streamline the communication process30
To address patient-related process failures, clinicians and health-care organizations should create a more robust infrastructure to support the patients’ role in breast care. More effective outreach programs are needed to educate patients about findings suggestive of a breast abnormality, the need for regular mammography, and the urgency of adhering to follow-up plans. These educational interventions must be tailored to at-risk populations, targeting women whose languages, cultures, or social situations make it difficult for them to understand or implement optimal breast care18
. A number of such interventions, including patient navigator programs and community-based outreach efforts, have shown some success,31,32
although further research is needed to determine which combination of initiatives is most efficacious for a given population.
This study has several limitations. First, the sample was selected from two Boston teaching hospitals and therefore may not be representative of a general population of women with breast cancer. However, the study hospitals treat almost half of all Boston residents with cancer, including one-third of the city’s racial minorities with cancer. Additionally, patients in this study were referred from within the hospitals’ wide primary care network, potentially mitigating the referral bias associated with cancer centers that provide primarily second opinion consultations. Second, the study is limited by the selection of cases from primary care practices with an EMR. While this approach facilitated data abstraction, it may limit the generalizability of the results beyond sites with electronic records. The EMR offers access to electronic reminders that may improve the quality of breast care, as well as easy access to electronic notes of providers who share the system. These features would presumably reduce the rate of missed and delayed diagnoses and under
estimate the rate of process failures in breast care. Similarly, exclusion of cases with limited clinician notes in the EMR may have resulted in selection bias that underestimated the rate of process failures if the clinicians most meticulous about their notes were also more conscientious caregivers. Third, the rate of process failures derives from a study cohort of women with self-reported delays or presentation with at least stage II disease. These rates cannot be readily generalized to other patient populations. Therefore, future studies are needed to create population-based estimates of the true incidence and prevalence of diagnostic errors. Nevertheless, these results identify vulnerabilities that may affect the care of patients in high-risk groups, and they corroborate results from malpractice claims-based studies, which suffer from additional biases8,33
. Finally, the study is limited by the challenge of ascertaining lapses in care. We relied on implicit judgments by physician reviewers using medical record review abstractions and on the quality of documentation in the medical record itself. Recognizing the difficulty of these judgments, reviewers generally presumed that care was adequate, absent evidence of a significant error or omission8,34,35
In spite of these potential limitations, our study demonstrates a high rate of process failures among patients with self-reported delays in cancer diagnosis and among those who presented with at least stage II disease. While many process failures were attributable to lapses in care rendered by frontline clinicians, patients themselves played a prominent role in about half of the failures. Improving breast cancer care, therefore, is a two-pronged challenge. It requires targeted interventions that educate and empower patients to monitor the symptoms that should trigger a visit to the physician, and it demands that clinicians be prepared to deliver high quality, coordinated care when those patients arrive.