Mary B. Barton

TEN-YEAR RISK OF FALSE POSITIVE SCREENING MAMMOGRAMS AND CLINICAL BREAST EXAMINATIONS

BACKGROUND The cumulative risk of a false positive result from a breast-cancer screening test is unknown. METHODS We performed a 10-year retrospective cohort study of breast-cancer screening and diagnostic evaluations among 2400 women who were 40 to 69 years old at study entry. Mammograms or clinical breast examinations that were interpreted as indeterminate, aroused a suspicion of cancer, or prompted recommendations for additional workup in women in whom breast cancer was not diagnosed within the next year were considered to be false positive tests. RESULTS A total of 9762 screening mammograms and 10,905 screening clinical breast examinations were performed, for a median of 4 mammograms and 5 clinical breast examinations per woman over the 10-year period. Of the women who were screened, 23.8 percent had at least one false positive mammogram, 13.4 percent had at least one false positive breast examination, and 31.7 percent had at least one false positive result for either test. The estimated cumulative risk of a false positive result was 49.1 percent (95 percent confidence interval, 40.3 to 64.1 percent) after 10 mammograms and 22.3 percent (95 percent confidence interval, 19.2 to 27.5 percent) after 10 clinical breast examinations. The false positive tests led to 870 outpatient appointments, 539 diagnostic mammograms, 186 ultrasound examinations, 188 biopsies, and 1 hospitalization. We estimate that among women who do not have breast cancer, 18.6 percent (95 percent confidence interval, 9.8 to 41.2 percent) will undergo a biopsy after 10 mammograms, and 6.2 percent (95 percent confidence interval, 3.7 to 11.2 percent) after 10 clinical breast examinations. For every 100 dollars spent for screening, an additional 33 dollars was spent to evaluate the false positive results. CONCLUSIONS Over 10 years, one third of women screened had an abnormal test result that required additional evaluation, even though no breast cancer was present. Techniques are needed to decrease false positive results while maintaining high sensitivity. Physicians should educate women about the risk of a false positive result from a screening test for breast cancer.

Management of breast cancer in elderly individuals: recommendations of the International Society of Geriatric Oncology.

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer mortality in women worldwide. Elderly individuals make up a large part of the breast cancer population, and there are important specific considerations for this population. The International Society of Geriatric Oncology created a task force to assess the available evidence on breast cancer in elderly individuals, and to provide evidence-based recommendations for the diagnosis and treatment of breast cancer in such individuals. A review of the published work was done with the results of a search on Medline for English-language articles published between 1990 and 2007 and of abstracts from key international conferences. Recommendations are given on the topics of screening, surgery, radiotherapy, (neo)adjuvant hormone treatment and chemotherapy, and metastatic disease. Since large randomised trials in elderly patients with breast cancer are scarce, there is little level I evidence for the treatment of such patients. The available evidence was reviewed and synthesised to provide consensus recommendations regarding the care of breast cancer in older adults.

Efficacy of Prophylactic Mastectomy in Women With Unilateral Breast Cancer: A Cancer Research Network Project

PURPOSE We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer. METHODS This retrospective cohort study comprised approximately 50,000 women who were diagnosed with unilateral breast cancer during 1979 to 1999. Using computerized data confirmed by chart review, we identified 1,072 women (1.9%) who had CPM. We obtained covariate information for these women and for a sample of 317 women who did not undergo CPM. RESULTS The median time from initial breast cancer diagnosis to the end of follow-up was 5.7 years. Contralateral breast cancer developed in 0.5% of women with CPM, metastatic disease developed in 10.5%, and subsequent breast cancer developed in 12.4%; 8.1% died from breast cancer. Contralateral breast cancer developed in 2.7% of women without CPM, and 11.7% died of breast cancer. After adjustment for initial breast cancer characteristics, treatment, and breast cancer risk factors, the hazard ratio (HR) for the occurrence of contralateral breast cancer after CPM was 0.03 (95% CI, 0.006 to 0.13). After adjustment for breast cancer characteristics and treatment, the HRs for the relationship of CPM with death from breast cancer, with death from other causes, and with all-cause mortality were 0.57 (95% CI, 0.45 to 0.72), 0.78 (95% CI, 0.57 to 1.06), and 0.60 (95% CI, 0.50 to 0.72), respectively. CONCLUSION CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality.

Screening and Treatment for Major Depressive Disorder in Children and Adolescents: US Preventive Services Task Force Recommendation Statement

DESCRIPTION. This is an update of the 2002 US Preventive Services Task Force recommendation on screening for child and adolescent major depressive disorder. METHODS. The US Preventive Services Task Force weighed the benefits and harms of screening and treatment for major depressive disorder in children and adolescents, incorporating new evidence addressing gaps in the 2002 recommendation statement. Evidence examined included the benefits and harms of screening, the accuracy of primary care–feasible screening tests, and the benefits and risks of treating depression by using psychotherapy and/or medications in patients aged 7 to 18 years. RECOMMENDATIONS. Screen adolescents (12–18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up (B recommendation). Evidence is insufficient to warrant a recommendation to screen children (7–11 years of age) for major depressive disorder (I statement).

Clinical Breast Examination: Practical Recommendations for Optimizing Performance and Reporting

Clinical breast examination (CBE) seeks to detect breast abnormalities or evaluate patient reports of symptoms to find palpable breast cancers at an earlier stage of progression. Treatment options for earlier‐stage cancers are generally more numerous, include less toxic alternatives, and are usually more effective than treatments for later‐stage cancers. For average‐risk women aged 40 and younger, earlier detection of palpable tumors identified by CBE can lead to earlier therapy. After age 40, when mammography is recommended, CBE is regarded as an adjunct to mammography. Recent debate, however, has questioned the contributions of CBE to the detection of breast cancer in asymptomatic women and particularly to improved survival and reduced mortality rates. Clinicians remain widely divided about the level of evidence supporting CBE and their confidence in the examination. Yet, CBE is practiced extensively in the United States and continues to be recommended by many leading health organizations. It is in this context that this report provides a brief review of evidence for CBEs role in the earlier detection of breast cancer, highlights current practice issues, and presents recommendations that, when implemented, could contribute to greater standardization of the practice and reporting of CBE. These recommendations may also lead to improved evidence of the nature and extent of CBEs contribution to the earlier detection of breast cancer.

Increased patient concern after false-positive mammograms: clinician documentation and subsequent ambulatory visits.

OBJECTIVE: To measure how often a breast-related concern was documented in medical records after screening mammography according to the mammogram result (normal, or truenegative vs false-positive) and to measure changes in health care utilization in the year after the mammogram.DESIGN: Cohort study.SETTING: Large health maintenance organization in New England.PATIENTS: Group of 496 women with false-positive screening mammograms and a comparison group of 496 women with normal screening mammograms, matched for location and year of mammogram.MEASUREMENTS AND MAIN RESULTS: 1) Documentation in clinicians’ notes of patient concern about the breast and 2) ambulatory health care utilization, both breast-related and non-breast-related, in the year after the mammogram. Fifty (10%) of 496 women with false-positive mammograms had documentation of breast-related concern during the 12 months after the mammogram, compared to 1 (0.2%) woman with a normal mammogram (P=.001). Documented concern increased with the intensity of recommended follow-up (P=.009). Subsequent ambulatory visits, not related to the screening mammogram, increased in the year after the mammogram among women with false-positive mammograms, both in terms of breast-related visits (incidence ratio, 3.07; 95% confidence interval [CI], 1.69 to 5.93) and non-breast-related visits (incidence ratio, 1.14; 95% CI, 1.03 to 1.25).CONCLUSIONS: Clinicians document concern about breast cancer in 10% of women who have false-positive mammograms, and subsequent use of health care services are increased among women with false-positive mammogram results.

Update on the Methods of the U.S. Preventive Services Task Force: Insufficient Evidence

The U.S. Preventive Services Task Force (USPSTF) is an independent panel of experts that is convened and supported by the Agency for Healthcare Research and Quality (AHRQ). The U.S. Congress has charged the USPSTF to review the scientific evidence for clinical preventive services and develop evidence-based recommendations about their delivery. In its recommendations, the USPSTF seeks to maximize population health benefits while minimizing harms. The target audience for USPSTF recommendations is primary care clinicians, but the recommendations are widely used by others as well (1). The USPSTF processes and methods are continually examined, and recent updates have been published (13). The USPSTF Procedure Manual is posted on the AHRQ Web site (4). In this issue, the USPSTF reports that it concluded that the evidence to determine whether the benefits of skin cancer screening outweigh the harms was insufficient (5). No recommendation was made, and no letter grade was assigned. Instead, the USPSTF issued an I statement (2). Evidence is often found to be insufficient for topics considered by the USPSTF. Even for screening topics that pertain to all or a large majority of adults, children, or adolescents, evidence is often insufficient (Table 1) (6). Table 1. Insufficient Evidence Statements for Screening of Large Population Subgroups The release of the I statement for skin cancer screening provides an opportunity for the USPSTF to describe its plan to expand the kinds of information it commissions to be collected and reported routinely by Evidence-based Practice Centers, to describe the process that led to selection of this information, and to illustrate the uses of the information with examples. Problem Statement Primary care physicians and their professional societies expressed frustration with the frequency with which the USPSTF concluded that evidence is insufficient to make a recommendation. In the past, the USPSTF coupled this conclusion with a recommendation worded as follows: the USPSTF concludes that the evidence is insufficient to recommend for or against routine provision of xxx service. Clinicians pointed out that this wording is not a recommendation. Anecdotally, the statement was characterized as useless and sometimes as worse than useless. In focus groups of practicing primary care providers, a common request was for USPSTF guidance on a course of action with individual patients in situations in which evidence about net benefit is insufficient. Professional society representatives reinforced the need for guidance. The USPSTF and other bodies have generally held that the strongest argument for providing an intervention is based on scientific evidence from multiple large, well-conducted, randomized clinical trials (RCTs). However, for most clinical preventive services, this standard of evidence is unattainable. Requirements for RCTs of behavioral counseling interventions are especially problematic because the study interventions in gold-standard RCTs may be artificial. Tucker and Roth (7) discuss this problem in the context of behavioral interventions for substance abuse. They point out that requiring fidelity in treatment delivery in a gold-standard RCT may eliminate the contextual aspects of the treatment experience and the adaptation of treatment to individual needs that underlies treatment success. Requiring a no-treatment or usual-treatment control condition may produce insurmountable barriers to recruitment. Requiring a control condition with the same number of contact hours as the treatment condition can compromise retention. For different reasons, the conduct of RCTs for preventive services delivered to infants, children, and adolescents also presents challenges. For some preventive services, the long timeline required to improve health outcomes makes RCTs impractical. Consensus is lacking about the appropriate outcomes for preventive interventions in children, although agreement is universal that decreasing mortality is not the only goal of preventive services provided to this age group. Finally, many valuable preventive interventions will never be evaluated in an RCT because a trial would be too expensive, recruiting enough participants is not feasible, or investigator interest or funding is lacking. Acknowledging the Contribution of Non-RCT Evidence and Persisting Issues Recognizing the paucity of evidence from RCTs, the USPSTF and other groups consider evidence from non-RCT study designs (such as cohort, cross-sectional, casecontrol, or quasi-experimental) as a standard strategy. Use of an analytic framework, which is an organizing principle for all recent or current USPSTF systematic reviews, permits incorporation of evidence from studies with a variety of designs and yields certainty that can in theory approach the certainty of evidence derived from RCTs. In constructing an analytic framework, clinical problems are conceptualized in terms of a sequence of key questions (8). A systematic review is generally done to answer each key question. When considered together, the key question evidence forms a chain of evidence that permits firm conclusions about net benefit. In the case of skin cancer, notwithstanding the use of an analytic framework and consideration of study designs other than RCTs, the USPSTF could not conclude with even moderate certainty that the benefits of skin cancer screening by inspection outweighed the harms or that the harms outweighed the benefits, making the evidence insufficient to make a recommendation (9). Even when non-RCT evidence is considered within a structured causal framework, the problem of insufficient evidence persists. A New Approach: Process and Outcome In response to the concerns about the frequency of I statements, the frustration expressed by clinicians, and the call for guidance, the USPSTF held a workshop in spring 2005 to consider how better to meet the needs of its constituents when evidence is insufficient. The workshop involved members of the USPSTF, AHRQ staff, and scientists from the Evidence-based Practice Center supporting the USPSTF. The charge to workshop participants was to develop a strategy that would reduce confusion created by the wording I recommendation, and to consider whether the USPSTF should nuance the Ithat is, make a suggestion in favor of or against providing the service. At the workshop, attendees heard presentations from AHRQ and Evidence-Based Practice Center staff involved in the efforts of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) working group (1012). Other publications about approaches to grading recommendations were identified and reviewed (13). The workshop resulted in a decision to transform what was formerly called an I recommendation into an I statement, as described elsewhere (2). The workshop also led to a group decision to reject the proposal to nuance the I. Nuancing would have resulted in recommendations that clinicians act routinely to offer a service even in the absence of at least moderate certainty that the preventive service has net benefits at the population level, thus violating an underlying principle guiding the work of USPSTF: avoidance of overall harm. Before the workshop, attendees were charged with bringing to the meeting suggestions for criteria that might be used to nuance the I, with practice relevance for clinicians, patients, or systems as the basis for these suggestions. During the workshop, further criteria were identified by using a brainstorming technique. The product of these processes was a list of possible factors that could be used to nuance the I. After rejecting the idea of nuancing the I, the USPSTF decided to explore, after the workshop, whether provision of information about the factors identified during this process might be useful to clinicians. This follow-up work was delegated to the Methods Workgroup and members of the Evidence-based Practice Center. The follow-up group noted that almost all of the factors fell into 1 of 4 groups. The 4 information groups came to be described as domains, a term that connotes hierarchical ranking and is apt, even if accidental. That is, these information domains constitute a limited number of broadly applicable collections of factors, considerations, or attributes pertinent to decision making about preventive services when evidence is insufficient to conclude, with certainty, that there is net benefit or net harm. After more deliberation, the Methods Workgroup proposed in 2006 that the Evidence-based Practice Center gather pertinent information in the 4 domains as part of its evidence retrieval process. The full USPSTF accepted the proposal, and members provided further input to the descriptions of the domains. The authors of this article were asked to prepare a manuscript about the process and product on behalf of the USPSTF. Domains and Rationale The first domain is potential preventable burden of suffering from the condition. When evidence is insufficient, provision of an intervention designed to prevent a serious condition (such as dementia) might be viewed more favorably than provision of a service designed to prevent a condition that does not cause as much suffering (such as rash). The USPSTF recognized that burden of suffering is subjective and involves judgment. In clinical settings, it should be informed by patient values and concerns. The second domain is potential harm of the intervention. When evidence is insufficient, an intervention with a large potential for harm (such as major surgery) might be viewed less favorably than an intervention with a small potential for harm (such as advice to watch less television). The USPSTF again acknowledges the subjective nature and the difficulty of assessing potential harms: For example, how bad is a mild stroke? The third domain is costnot just monetary cost, but opportunity cost, in particular the amount of time a provider spends to provide the service

Barriers to self-monitoring of blood glucose among adults with diabetes in an HMO: A cross sectional study

BackgroundRecent studies suggest that patients at greatest risk for diabetes complications are least likely to self-monitor blood glucose. However, these studies rely on self-reports of monitoring, an unreliable measure of actual behavior. The purpose of the current study was to examine the relationship between patient characteristics and self-monitoring in a large health maintenance organization (HMO) using test strips as objective measures of self-monitoring practice.MethodsThis cross-sectional study included 4,565 continuously enrolled adult managed care patients in eastern Massachusetts with diabetes. Any self-monitoring was defined as filling at least one prescription for self-monitoring test strips during the study period (10/1/92–9/30/93). Regular SMBG among test strip users was defined as testing an average of once per day for those using insulin and every other day for those using oral sulfonylureas only. Measures of health status, demographic data, and neighborhood socioeconomic status were obtained from automated medical records and 1990 census tract data.ResultsIn multivariate analyses, lower neighborhood socioeconomic status, older age, fewer HbA1c tests, and fewer physician visits were associated with lower rates of self-monitoring. Obesity and fewer comorbidities were also associated with lower rates of self-monitoring among insulin-managed patients, while black race and high glycemic level (HbA1c>10) were associated with less frequent monitoring. For patients taking oral sulfonylureas, higher dose of diabetes medications was associated with initiation of self-monitoring and HbA1c lab testing was associated with more frequent testing.ConclusionsManaged care organizations may face the greatest challenges in changing the self-monitoring behavior of patients at greatest risk for poor health outcomes (i.e., the elderly, minorities, and people living in low socioeconomic status neighborhoods).

Reconsidering the Approach to Prevention Recommendations for Older Adults

The U.S. Preventive Services Task Force (USPSTF) bases its recommendations on an evidence-based model of clinical prevention that focuses on specific diseases, well-defined preventive interventions, and evidence of improved health outcomes. Applying this model to prevention for very old patients has been problematic for several reasons: Many geriatric disorders have multiple risk factors, interventions, and expected outcomes; older adults are not often represented in clinical trials; and important outcomes may not be measured and reported in ways that are conducive to evidence synthesis and interpretation. In 2005, the USPSTF convened a geriatrics workgroup to refine USPSTF methodology and processes to better address the preventive needs of older adults. The USPSTF has begun to apply these new approaches to the review and recommendation on interventions to prevent falls in older adults.

Breast Cancer Screening Use by African Americans and Whites in an HMO

AbstractOBJECTIVE: To examine racial differences in breast cancer screening in an HMO that provides screening at no cost. DESIGN: Retrospective cohort study of breast cancer screening among African-American and white women. Breast cancer screening information was extracted from computerized medical records. SETTING: A large HMO in New England. PATIENTS/PARTICIPANTS: White and African-American women (N=2,072) enrolled for at least 10 years in the HMO. MAIN RESULTS: Primary care clinicians documented recommending a screening mammogram significantly more often for African Americans than whites (70% vs 64%; P<.001). During the 10-year period, on average, white women obtained more mammograms (4.49 vs 3.93; P<.0001) and clinical breast examinations (5.35 vs 4.92; P<.01) than African-American women. However, a woman’s race was no longer a statistically significant predictor of breast cancer screening after adjustment for differences in age, estimated household income, estrogen use, and body mass index (adjusted number of mammograms, 4.47 vs 4.25, P=.17; and adjusted number of clinical breast examinations, 5.35 vs 5.31, P=.87). CONCLUSIONS: In this HMO, African-American and white women obtained breast cancer screening at similar rates. Comparisons with national data showed much higher screening rates in this HMO for both white and African-American women.