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Quality assessment is critical for healthcare reform, but data sources are lacking for measurement of many important healthcare outcomes. With over 49 million people covered by Medicare as of 2010, Medicare claims data offer a potentially valuable source that could be used in targeted health care quality improvement efforts. However, little is known about the operating characteristics of provider profiling methods using claims-based outcome measures that may estimate provider performance with error. Motivated by the example of screening mammography performance, we compared approaches to identifying providers failing to meet guideline targets using Medicare claims data. We used data from the Breast Cancer Surveillance Consortium and linked Medicare claims to compare claims-based and clinical estimates of cancer detection rate. We then demonstrated the performance of claim-based estimates across a broad range of operating characteristics using simulation studies. We found that identification of poor performing providers was extremely sensitive to algorithm specificity, with no approach identifying more than 65% of poor performing providers when claims-based measures had specificity of 0.995 or less. We conclude that claims have the potential to contribute important information on healthcare outcomes to quality improvement efforts. However, to achieve this potential, development of highly accurate claims-based outcome measures should remain a priority. Copyright © 2014 John Wiley & Sons, Ltd.

Objectives Identifying the distributions and determinants of fluoroscopy time for invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI). Background ICA and PCI are significant contributors to radiation exposure from medical imaging in the US. Fluoroscopy time is a potentially modifiable determinant of radiation exposure for these procedures, but has not been well characterized in contemporary practice. Methods We evaluated the distribution of fluoroscopy time in patients undergoing ICA and/or PCI in the CathPCI Registry®, stratifying patients by numerous clinical scenarios. Hierarchical models were used to determine patient, procedure, operator and hospital-level factors associated with fluoroscopy time for these procedures. Results Our study included a total of 3,295,348 ICA and PCI procedures performed by 9,600 operators from January 2005 through June 2009. There was wide variation in fluoroscopy times for these procedures with median [IQR] fluoroscopy times of 2.6 [1.7–4.5] minutes for ICA, 6.7 [4.2–10.8] minutes for ICA in patients with prior coronary artery bypass grafting (CABG), 10.1 [6.0–17.4] minutes for PCI, 10.7 [7.0–16.9] minutes for PCI with ICA, and 16.0 [10.6–24.0] minutes for PCI and ICA in patients with prior CABG. Prolonged fluoroscopy times (>30 minutes) were rare for ICA, but occurred in 6.7% of PCIs and 14.7% of PCIs in patients with prior CABG. After accounting for patient characteristics and procedure complexity, operator and hospital-level factors explained nearly 20% of the variation in fluoroscopy time. Conclusions Fluoroscopy times vary widely during ICA and PCI with operator and hospital-level factors contributing substantially to these differences. A better understanding of potentially modifiable sources of this variation will elucidate opportunities for enhancing the radiation safety of these procedures. © 2013 Wiley Periodicals, Inc.

To compare the accuracy of several approaches for defining prevalent vertebral fractures from measurements of vertebral dimensions (morphometry), we measured the lateral dimensions of vertebral bodies of 115 normal premenopausal and 100 postmenopausal women. Of the postmenopausal women two observers agreed that 49 had definite vertebral fractures and 38 were definitely normal. Using these classifications as an independent reference, women were then classified as fractured or normal by several definitions based on vertebral morphometry. No morphometric definition of vertebral fracture agreed perfectly with the consensus classifications. In general, definitions that involved combinations of measurements of anterior (Ha), middle (Hm), and posterior (Hp) vertebral height classified women more accurately than did definitions based on a single measurement or ratio. The Ha/Hp ratio produced many false positives unless it was adjusted for normal variations in the shapes of different vertebral bodies. Definitions of fracture based on a greater than 15% reduction in heights or ratios had higher sensitivity but more false positives than definitions that used a more stringent (greater than 20%) criterion. All morphometric definitions of vertebral fracture separated the post-menopausal women into two groups (fractured and normal) that had significantly (P less than 0.001) different mean spine bone density by quantitative computed tomography. Definitions that had the lowest rates of false positives also produced the largest differences in bone density between those defined as fractured and those defined as normal.

The reasons for race/ethnicity (R/E) differences in breast cancer survival have been difficult to disentangle.Surveillance, Epidemiology, and End Results (SEER)-Medicare data were used to identify 41,020 women agedor =68 years with incident breast cancer between 1994-1999 including African American (2479), Hispanic (1172), Asian/Pacific Island (1086), and white women (35,878). A Cox proportional hazards model assessed overall and stage-specific (0/I, II/III, and IV) R/E differences in breast cancer survival after adjusting for mammography screening, tumor characteristics at diagnosis, biologic markers, treatment, comorbidity, and demographics.African American women had worse survival than white women, although controlling for predictor variables reduced this difference among all stage breast cancer (hazards ratio [HR], 1.08; 95% confidence interval [95% CI], 0.97-1.20). Adjustment for predictors reduced, but did not eliminate, disparities in the analysis limited to women diagnosed with stage II/III disease (HR, 1.30; 95% CI, 1.10-1.54). Screening mammography, tumor characteristics at diagnosis, biologic markers, and treatment each produced a similar reduction in HRs for women with stage II/III cancers. Asian and Pacific Island women had better survival than white women before and after accounting for all predictors (adjusted all stages HR, 0.61 [95% CI, 0.47-0.79]; adjusted stage II/III HR, 0.61 [95% CI, 0.47-0.79]). Hispanic women had better survival than white women in all and stage II/III analysis (all stage HR, 0.88; 95% CI, 0.75-1.04) and stage II/III analysis (HR, 0.88; 95% CI, 0.75-1.04), although these findings did not reach statistical significance. There was no significant difference in survival by R/E noted among women diagnosed with stage IV disease.Predictor variables contribute to, but do not fully explain, R/E differences in breast cancer survival for elderly American women. Future analyses should further investigate the role of biology, demographics, and disparities in quality of care.

Objective To determine the association between second trimester ultrasound findings (genetic sonogram) and the risk of Down syndrome. Methods Prospective population-based cohort study of women who were at increased risk of chromosome abnormality based on serum screening. Results Overall 9244 women with singleton pregnancies were included, including 245 whose fetuses had Down syndrome. Overall, 15.3% of the women had an abnormal genetic sonogram, including 14.2% of pregnancies with normal fetuses and 53.1% of those with Down syndrome. If the genetic sonogram were normal, the risk that a woman had a fetus with Down syndrome was reduced (likelihood ratio 0.55 [95% CI 0.49, 0.62]) However, if the normal genetic sonogram were used to counsel these high-risk women that they could avoid amniocentesis, approximately half of the cases of Down syndrome (115 of 245) would have been missed. The isolated ultrasound soft markers were the most commonly observed abnormality. These were seen in a high proportion of Down syndrome fetuses (13.9%) and normal fetuses (9.3%). In the absence of a structural anomaly, the isolated ultrasound soft markers of choroid plexus cyst, echogenic bowel, renal pyelectasis, clenched hands, clinodactyly, two-vessel umbilical cord, short femur, and short humerus were not associated with Down syndrome. Nuchal fold thickening was a notable exception, as a thick nuchal fold raised the risk of Down syndrome even when it was seen without an associated structural anomaly. Limitations All women included in this study were at high risk of Down syndrome based on serum screening, and thus the results of this study cannot be used as a basis to modify maternal age-related risk. Conclusions The accuracy of the genetic sonogram is less than previously reported. The genetic sonogram should not be used as a sequential test following serum biochemistry, as this would substantially reduce the prenatal diagnosis of Down syndrome cases. In contrast to prior reports, most isolated soft markers were not associated with Down syndrome. Copyright © 2007 John Wiley & Sons, Ltd.

BACKGROUND It is unknown whether differences in the quality of breast cancer care among women from racial and ethnic minority groups, the elderly, and rural areas have changed over time across the continuum of care. METHODS The linked Surveillance, Epidemiology, and End Results-Medicare database identified 22,701 women ages 66–79 years diagnosed with early stage breast cancer from 1992–1999. Multiple breast cancer processes of care were measured, including breast-conserving surgery, radiation therapy, documentation of estrogen receptor status, surveillance mammography, and a combined measure of “adequate care”. RESULTS African-American and Hispanic women were significantly less likely to receive adequate care than White women in unadjusted comparisons (54.7% and 58.0% vs. 68.4% for African-American and Hispanic vs. White women) and adjusted comparisons (adjusted odds ratio [AOR] 0.67; 95% confidence interval [95% CI] 0.59–0.76, and AOR 0.77; 95% CI 0.66–0.90 for African-American and Hispanic women, respectively). The proportion of Asian/Pacific Islander women receiving adequate care was similar to White women. When considering only women diagnosed with breast cancer from 1997–1999, African-American women remained less likely than White women to receive adequate care (AOR 0.63; 95% CI 0.50–0.79). Women ages 75–79 years were less likely to receive adequate care compared with women ages 66–69 years (AOR 0.74; 95% CI 0.69–0.80), and women from rural (vs. metropolitan) areas were less likely to receive adequate care (AOR 0.81; 95% CI 0.73–0.89). CONCLUSIONS The quality of breast cancer care is lower among vulnerable populations across the continuum of care, and many of these differences have not improved in more recent years. Cancer 2005. © 2005 American Cancer Society.

Objective Transvaginal sonography (TVS) is routinely performed as part of a pelvic sonogram in postmenopausal women, and images of the endometrium are frequently obtained. In women without vaginal bleeding, the threshold separating normal from abnormally thickened endometrium is not known. The aim of this study was to determine an endometrial thickness threshold that should prompt biopsy in a postmenopausal woman without vaginal bleeding. Methods This was a theoretical cohort of postmenopausal women aged 50 years and older who were not receiving hormone therapy. We determined the risk of cancer for a postmenopausal woman with vaginal bleeding when the endometrial thickness measures > 5 mm, and then determined the endometrial thickness in a woman without vaginal bleeding that would be associated with the same risk of cancer. We used published and unpublished data to determine the sensitivity and specificity of TVS, the incidence of endometrial cancer, the percentage of women symptomatic with vaginal bleeding, and the percentage of cancer that occurs in women without vaginal bleeding. Ranges for each estimate were included in a sensitivity analysis to determine the impact of each estimate on the overall results. Results In a postmenopausal woman with vaginal bleeding, the risk of cancer is approximately 7.3% if her endometrium is thick (> 5 mm) and 11 mm) and 0.002% if the endometrium is thin (≤ 11 mm). The estimated risk of cancer was sensitive to the percentage of cancer cases that were estimated to occur in women without vaginal bleeding. For the base case we estimated that 15% of cancers occur in women without vaginal bleeding. When we changed the estimate to project that only 5% of cancers occur in women without vaginal bleeding, the projected risk of cancer with a thick measurement was only 2.2%, whereas when we estimated that 20% of endometrial cancers occur in women without bleeding, the projected risk of cancer with a thick measurement was 8.9%. As a woman's age increases, her risk of cancer increases at each endometrial thickness measurement. For example, using the 11 mm threshold, the risk of cancer associated with a thick endometrium increases from 4.1% at age 50 years to 9.3% at age 79 years. Varying the other estimates used in the decision analysis within plausible ranges had no substantial effect on the results. Conclusions In a postmenopausal woman without vaginal bleeding, if the endometrium measures > 11 mm a biopsy should be considered as the risk of cancer is 6.7%, whereas if the endometrium measures ≤ 11 mm a biopsy is not needed as the risk of cancer is extremely low. Copyright © 2004 ISUOG. Published by John Wiley & Sons, Ltd.

Objectives Although prenatal ultrasound is broadly used to detect abnormal fetuses, the variability in the interpretation of second-trimester prenatal ultrasound examinations is unknown. We sought to evaluate the consistency of the interpretation of prenatal ultrasound examinations. Design Physicians who perform prenatal ultrasound and who participate in the California Maternal Serum Expanded AFP program were asked to interpret a series of test ultrasound examinations. The series of cases was selected to include a random sample of fetal structural abnormalities, ultrasound markers that have been associated with chromosomal abnormalities, and normal cases. Interobserver agreement was evaluated using a κ statistic for each organ system. The sensitivity and false-positive rate were calculated for detecting specific anatomic abnormalities within each organ system. Results Of the 210 sonologists eligible for inclusion in the study, completed responses were received from 148 (70%). There was moderate to substantial agreement between physicians in reporting the presence of fetal abnormalities for all organ systems (κ range 0.40–0.88, P < 0.001). The consistency was highest for the central nervous system (CNS), neck, and face. Within each organ system, the consistency was similar for major structural abnormalities and ultrasound markers of chromosomal abnormalities. The sensitivity ranged from 62% (95% confidence interval (CI) 58–66%) for major renal abnormalities to 91% (95% CI 88–94%) for CNS abnormalities, with corresponding false-positive rates of 7% (95% CI 6–9%) for renal abnormalities and 9% (95% CI 7–11%) for CNS abnormalities. For most organ systems, the sensitivity for detecting ultrasound markers of chromosomal abnormalities was similar to the sensitivity for detecting structural abnormalities. Conclusion There is moderate to substantial agreement in the interpretation of second-trimester prenatal ultrasound examinations. Whether the identification of specific ultrasound abnormalities and markers is overall beneficial to patients remains to be determined. Copyright © 2001 International Society of Ultrasound in Obstetrics and Gynecology

Purpose: To develop and demonstrate an automated computational method used to provide organ and effective dose assessments of computed tomography(CT) examinations, using a pre‐calculated organ dose database.Methods: A five dimensional organ dose matrix, D (33 organs, 6 age groups, 2 genders, 3 tube potentials, scan positions with 1 cm z‐resolution), was calculated using a Monte Carlo transport method which couples a reference CTscanner model (Siemens Sensation 16) with a series of pediatric and adult hybrid computational phantoms. CT scans with a given scan range were approximated as the sum of doses from multiple axial slices included in the scan range of interest. Patient‐specific doses were calculated using the organ and effective doses normalized to CTDIvol of the reference scanner and patient/scan‐specific parameters: body part scanned, CTDIvol, age, gender, scan length, kVp, and mAs. The parameters were obtained from a manually‐ and electronically‐extracted DICOM dataset of 3,982 CT exams randomly selected from five health care systems participating in the NCI‐funded Cancer Research Network (CRN). Illustrative dose analysis and comparison of dose for a subset of scans were performed. Results: Based on an evaluation of 3,983 CT examinations the following values were provided: effective dose, CTDIvol, dose length product (DLP) and the absorbed doses for 33 organs. Illustrative analysis for brain dose in head scans revealed a large dose variation in the age less than 30‐year scans (COV=0.445) compared to the age above 30‐year (COV=0.104). We observed that brain dose is strongly correlated with scan length compared to other scan parameters. Conclusion: The automated organ and effective dose calculation method developed in this study reduces the time needed to calculate doses on a large number of patients. We have successfully utilized this program for a variety of CT‐related studies including retrospective epidemiological study and CT dose trend analysis studies.