Progress of health plans toward meeting the million hearts clinical target for high blood pressure control - United States, 2010-2012.

High blood pressure is a major cardiovascular disease risk factor and contributed to >362,895 deaths in the United States during 2010. Approximately 67 million persons in the United States have high blood pressure, and only half of those have their condition under control. An estimated 46,000 deaths could be avoided annually if 70% of patients with high blood pressure were treated according to published guidelines. To assess blood pressure control among persons with health insurance, CDC and the National Committee for Quality Assurance (NCQA) examined data in the 2010-2012 Healthcare Effectiveness Data and Information Set (HEDIS). In 2012, approximately 113 million adults aged 18-85 years were covered by health plans measured by HEDIS. The HEDIS controlling blood pressure (CBP) performance measure is the proportion of enrollees with a diagnosis of high blood pressure confirmed in their medical record whose blood pressure is controlled. Overall, only 64% of enrollees with diagnosed high blood pressure in HEDIS-reporting plans had documentation that their blood pressure was controlled. Although these findings signal that additional work is needed to meet the 70% target, modest improvements since 2010, coupled with focused efforts, might make it achievable.

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.

Update on the methods of the U.S. Preventive Services Task Force: insufficient evidence.

The U.S. Preventive Services Task Force (USPSTF) seeks to provide reliable and accurate evidence-based recommendations to primary care clinicians. However, clinicians indicate frustration with the lack of guidance provided by the USPSTF when the evidence is insufficient to make a recommendation. This article describes a new USPSTF plan to commission its Evidence-based Practice Centers to collect information in 4 domains pertinent to clinical decisions about prevention and to report this information routinely. The 4 domains are potential preventable burden, potential harm of the intervention, costs (both monetary and opportunity), and current practice. The process and rationale used to select these domains are presented, along with examples of how clinicians might use the information to guide clinical decision making when evidence is insufficient.

Screening for chronic obstructive pulmonary disease using spirometry: summary of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States. Fewer than half of the estimated 24 million Americans with airflow obstruction have received a COPD diagnosis, and diagnosis often occurs in advanced stages of the disease. PURPOSE: To summarize the evidence on screening for COPD using spirometry for the U.S. Preventive Services Task Force (USPSTF). DATA SOURCES: English-language articles identified in PubMed and the Cochrane Library through January 2007, recent systematic reviews, expert suggestions, and reference lists of retrieved articles. STUDY SELECTION: Explicit inclusion and exclusion criteria were used for each of the 8 key questions on benefits and harms of screening. Eligible study types varied by question. DATA EXTRACTION: Studies were reviewed, abstracted, and rated for quality by using predefined USPSTF criteria. DATA SYNTHESIS: Pharmacologic treatments for COPD reduce acute exacerbations in patients with severe disease. However, severe COPD is uncommon in the general U.S. population. Spirometry has not been shown to independently increase smoking cessation rates. Potential harms from screening include false-positive results and adverse effects from subsequent unnecessary therapy. Data on the prevalence of airflow obstruction in the U.S. population were used to calculate projected outcomes from screening groups defined by age and smoking status. LIMITATION: No studies provide direct evidence on health outcomes associated with screening for COPD. CONCLUSION: Screening for COPD using spirometry is likely to identify a predominance of patients with mild to moderate airflow obstruction who would not experience additional health benefits if labeled as having COPD. Hundreds of patients would need to undergo spirometry to defer a single exacerbation.

How to read the new recommendation statement: methods update from the U.S. Preventive Services Task Force.

Since 2001, the U.S. Preventive Services Task Force (USPSTF) has worked to refine its methods of evidence review and assessment and to create more usable documents in response to clinicians' needs. These changes have resulted in a revised grading system, as well as a new format and new language for the recommendation statement. This paper focuses on the changes to and the new look of the USPSTF recommendation statement. The new recommendation statement comprises 9 sections. Important changes include standardization of the format of the summary statement to specify what service is being recommended in what population; standardization of the headings in the rationale section; a change in the wording of the grade C recommendation and the I statement; and a new section, called "Other Considerations," in which salient issues related to cost-effectiveness, mandates, and other implementation issues are described.

Specificity of clinical breast examination in community practice.

BACKGROUND: Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (approximately 94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity. OBJECTIVE: To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity. DESIGN: Retrospective cohort study. SUBJECTS: Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484). MEASUREMENTS: Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered "average-risk" if they had neither a family history of breast cancer nor a prior breast biopsy and "increased-risk" otherwise. RESULTS: Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8-99.7%] and 97.1% (95% CI: 95.7-98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7-76.5%) and 57.1% (95% CI: 51.1-63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10-0.46). CONCLUSIONS: Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.

The effect of immediate reading of screening mammograms on medical care utilization and costs after false-positive mammograms.

OBJECTIVE: To investigate whether decreased anxiety associated with immediate reading of screening mammograms resulted in lower downstream utilization and costs among women with false-positive mammograms. DATA SOURCES/STUDY SETTING: We identified 1,140 women, > or =age 40, with false-positive mammograms and 12-month follow-up after participating in a trial of immediate versus batch mammographic reading between February 1999 and January 2001 in a multispecialty group managed care practice in Massachusetts. STUDY DESIGN: We determined downstream utilization and costs for study participants by immediate and batch reading status. DATA COLLECTION/EXTRACTION METHODS: Demographic, comorbidity, and medical care utilization data were obtained from survey data and computerized medical record databases. Costs included direct medical costs, patient time, travel and copayments, and additional professional time costs associated with immediate reading. PRINCIPAL FINDINGS: Immediate reading cost an additional $4.40 per screening mammogram. Women with immediate readings had more follow-up mammograms (781 versus 750, p=.018) and fewer diagnostic ultrasounds (176 versus 219, p=.016) than women with batch readings. Costs to the health plan for breast care were approximately 10 percent higher for immediate readings in multivariable analyses (p=.046), but no significant difference was seen in total societal costs (p=.072). CONCLUSIONS: Immediate mammogram reading was associated with increased costs to the health plan and changes in follow-up radiology procedures. These costs must be examined alongside beneficial effects of immediate reading.

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.

Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes.

OBJECTIVE: This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey. STUDY DESIGN AND SETTING: We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation. RESULTS: IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs. CONCLUSION: Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies.

A population-based study of bilateral prophylactic mastectomy efficacy in women at elevated risk for breast cancer in community practices.

BACKGROUND: Findings from several studies suggest that bilateral prophylactic mastectomy reduces breast cancer incidence by 90% or more, but the studies used highly selected patients from referral centers, and the comparison groups were not population based. We studied the efficacy of bilateral prophylactic mastectomy in women with elevated breast cancer risk cared for in community practices. METHODS: We conducted a retrospective case-cohort study of women aged 18 to 80 years with 1 or more breast cancer risk factors (family history of breast cancer, history of atypical hyperplasia, or > or =1 breast biopsies with benign findings). Using computerized data and medical records, we identified 276 women with bilateral prophylactic mastectomy and a stratified random sample of 196 women representing an underlying cohort of 666 800 women with elevated breast cancer risk without prophylactic mastectomy, and then we determined who developed breast cancer. RESULTS: Breast cancer developed in 1 woman (0.4%) after bilateral prophylactic mastectomy vs 26 800 women (4.0%) without prophylactic mastectomy. Stratifying by birth year, the hazard ratio for breast cancer occurrence after bilateral prophylactic mastectomy was 0.005 (95% confidence interval, 0.001-0.044). No woman with bilateral prophylactic mastectomy died of breast cancer vs a calculated 0.2% of women without prophylactic mastectomy. CONCLUSIONS: Bilateral prophylactic mastectomy reduced breast cancer incidence in women at elevated risk for breast cancer cared for in community-based practices. However, the absolute risk of breast cancer incidence and death in women who did not undergo the procedure in these settings was relatively low.

Screening mammograms by community radiologists: variability in false-positive rates.

BACKGROUND: Previous studies have shown that the agreement among radiologists interpreting a test set of mammograms is relatively low. However, data available from real-world settings are sparse. We studied mammographic examination interpretations by radiologists practicing in a community setting and evaluated whether the variability in false-positive rates could be explained by patient, radiologist, and/or testing characteristics. METHODS: We used medical records on randomly selected women aged 40-69 years who had had at least one screening mammographic examination in a community setting between January 1, 1985, and June 30, 1993. Twenty-four radiologists interpreted 8734 screening mammograms from 2169 women. Hierarchical logistic regression models were used to examine the impact of patient, radiologist, and testing characteristics. All statistical tests were two-sided. RESULTS: Radiologists varied widely in mammographic examination interpretations, with a mass noted in 0%-7.9%, calcification in 0%-21.3%, and fibrocystic changes in 1.6%-27.8% of mammograms read. False-positive rates ranged from 2.6% to 15.9%. Younger and more recently trained radiologists had higher false-positive rates. Adjustment for patient, radiologist, and testing characteristics narrowed the range of false-positive rates to 3.5%-7.9%. If a woman went to two randomly selected radiologists, her odds, after adjustment, of having a false-positive reading would be 1.5 times greater for the radiologist at higher risk of a false-positive reading, compared with the radiologist at lowest risk (95% highest posterior density interval [similar to a confidence interval] = 1.17 to 2.08). CONCLUSION: Community radiologists varied widely in their false-positive rates in screening mammograms; this variability range was reduced by half, but not eliminated, after statistical adjustment for patient, radiologist, and testing characteristics. These characteristics need to be considered when evaluating false-positive rates in community mammographic examination screening.

Using Electronic Health Record Data to Measure Care Quality for Individuals with Multiple Chronic Medical Conditions.

OBJECTIVES: To inform the development of a data-driven measure of quality care for individuals with multiple chronic conditions (MCCs) derived from an electronic health record (EHR). DESIGN: Qualitative study using focus groups, interactive webinars, and a modified Delphi process. SETTING: Research department within an integrated delivery system. PARTICIPANTS: The webinars and Delphi process included 17 experts in clinical geriatrics and primary care, health policy, quality assessment, health technology, and health system operations. The focus group included 10 individuals aged 70-87 with three to six chronic conditions selected from a random sample of individuals aged 65 and older with three or more chronic medical conditions. MEASUREMENTS: Through webinars and the focus group, input was solicited on constructs representing high-quality care for individuals with MCCs. A working list was created of potential measures representing these constructs. Using a modified Delphi process, experts rated the importance of each possible measure and the feasibility of implementing each measure using EHR data. RESULTS: High-priority constructs reflected processes rather than outcomes of care. High-priority constructs that were potentially feasible to measure included assessing physical function, depression screening, medication reconciliation, annual influenza vaccination, outreach after hospital admission, and documented advance directives. High-priority constructs that were less feasible to measure included goal setting and shared decision-making, identifying drug-drug interactions, assessing social support, timely communication with patients, and other aspects of good customer service. Lower-priority domains included pain assessment, continuity of care, and overuse of screening or laboratory testing. CONCLUSION: High-quality MCC care should be measured using meaningful process measures rather than outcomes. Although some care processes are currently extractable from electronic data, capturing others will require adapting and applying technology to encourage holistic, person-centered care.

Complications following bilateral prophylactic mastectomy.

BACKGROUND: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort. METHODS: Women aged 18-80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure. RESULTS: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055). CONCLUSION: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.

Screening clinical breast examination: how often does it miss lethal breast cancer?

BACKGROUND: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women who ultimately died of breast cancer, as well as to identify factors associated with accurate detection. SUBJECTS AND METHODS: We evaluated CBE accuracy among asymptomatic female health plan enrollees in five states (WA, OR, CA, MA, and MN) who received a CBE within 1 year of breast cancer diagnosis and who died of breast cancer within 15 years of diagnosis (N = 485). Sensitivity was estimated as the proportion whose exam was abnormal. Bivariate and logistic regression analyses identified patient characteristics associated with cancer detection. RESULTS: An abnormality was noted on screening CBE in one of five women who ultimately succumbed to breast cancer (sensitivity = 21.6%; 95% confidence interval [CI] = 18.1% to 25.6%). The odds of a true-positive screening CBE (sensitivity) were decreased among women using estrogen (odds ratio [OR] = 0.23; 95% CI = 0.07 to 0.80), receiving a Pap smear during the same visit as CBE (OR = 0.45; 95% CI = 0.27 to 0.72), and with increasing chronic disease comorbidity (P(trend) = .08). CONCLUSION: Screening CBE as performed in the community may be insufficiently sensitive to detect most lethal breast cancers. Low sensitivity of screening CBE in community practice may be partly attributable to its performance alongside time-consuming clinical tasks such as Pap smear screening or chronic illness care.

Race and ethnicity: comparing medical records to self-reports.

Understanding and eliminating health disparities requires accurate data on race/ethnicity. To assess the quality of race/ethnicity data, we compared medical record classifications to self-report of a study of prophylactic mastectomy. A total of 788 women had race/ethnicity from both sources; 69.9% were 55 years of age or older, 38.3% were at least college graduates, and 67.8% were married or living with someone. There were 817 race/thnicity classifications for the 788 women, of which 758 (92.3%) were identical in the medical record and self-report. Sensitivity and positive predictive value were high (86.7%-97.2%) for whites, Asians, and blacks and moderate (64.0% and 68.1%) for Latinas. However, only one of 18 Native Americans was correctly identified in her medical record. Our results indicate that even if the overall accuracy of medical record classifications for race/ethnicity is high, such a finding may obscure substantial inaccuracies in the recording for racial/ethnic minorities, especially Latinas and Native Americans.

Screening for colorectal, breast, and cervical cancer in the elderly: a review of the evidence.

There is general consensus that screening can reduce mortality from colorectal, breast, and cervical cancer among persons in their 50s and 60s. However, few screening trials have included persons over age 70 years. Therefore, indirect evidence must be used to determine when results in younger persons should be extrapolated to older persons. In this review, we focus on cancer screening tests that are well accepted in younger persons (mammography, Papanicolaou smears, and colorectal cancer screening) and discuss the strength of inference concerning benefits and harms of screening older persons. Some aspects of aging favor screening (eg, increased absolute risk of dying of cancer) whereas other aspects do not (eg, decreased life expectancy). Age also affects the behavior of some cancers (eg, increases the proportion of slow-growing breast cancers) and affects the accuracy of some screening tests (eg, increases the accuracy of mammography; decreases the accuracy of sigmoidoscopy). These effects make the application of evidence in younger populations to older populations complex. However, given the heterogeneity of the elderly population, there is no evidence of one age at which potential benefits of screening suddenly cease or potential harms suddenly become substantial for everyone. Therefore, characteristics of individual patients that go beyond age should be the driving factors in screening decisions. For example, persons who have a life expectancy less than 5 years or persons who would decline treatment should generally not be screened. Decisions to either continue or discontinue screening in the elderly should be based on health status, the benefits and harms of the test, and preferences of the patient, rather than solely on the age of the patient.

Breast cancer screening. Benefits, risks, and current controversies.

Mammography is the best tool available for screening for breast cancer. Although the data supporting clinical breast examination are not as strong, this procedure continues to be widely used in the United States. To maximize accuracy of results, women who undergo screening during their premenopausal years should attempt to schedule mammography during the follicular phase of the menstrual cycle. All women should be educated about the benefits and the harms of screening, including the risk of being called back for further testing.

Comparing breast cancer case identification using HMO computerized diagnostic data and SEER data.

OBJECTIVE: To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases. STUDY DESIGN: An HMO without a cancer registry developed an algorithm identifying incident breast cancer cases using computerized diagnostic codes. Two other HMO sites with Surveillance, Epidemiology, and End Results (SEER) registries duplicated this case-identification approach. Using the SEER registries as the criterion standard, we determined the sensitivity and PPV of the computerized data. METHODS: Data were collected from HMO computerized data-bases between January 1, 1996, and December 31, 1999. Surveillance, Epidemiology, and End Results data were also used. RESULTS: The overall sensitivity of the HMO databases was between 0.92 (95% confidence interval [CI], 0.91-0.96) and 0.99 (95% CI, 0.98-0.99). Sensitivity was high (range, 0.94-0.98), for the first 3 (of 4) years, dropping slightly (range, 0.81-0.94) in the last year. The overall PPV ranged from 0.34 (95% CI, 0.32-0.35) to 0.44 (95% CI, 0.42-0.46). Positive predictive value rose sharply (range, 0.18-0.20) after the first year to 0.83 and 0.92 in the last year because prevalent cases were excluded. Review of a random sample of 50 cases identified in the computerized data-bases but not by SEER data indicated that, while SEER usually identified the cases, the registry did not associate every case with the health plan. CONCLUSIONS: Health maintenance organization computerized databases were highly sensitive for identifying incident breast cancer cases, but PPV was low in the initial year because the systems did not differentiate between prevalent and incident cases. Health maintenance organizations depending solely on SEER data for cancer case identification will miss a small percentage of cases.

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

BACKGROUND: Recent 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. METHODS: This 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. RESULTS: In 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. CONCLUSIONS: Managed 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).