Robert D. Wellman

A Randomized Trial Comparing Yoga, Stretching, and a Self-care Book for Chronic Low Back Pain

BACKGROUND Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. METHODS A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. RESULTS After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, -2.5 [95% CI, -3.7 to -1.3]; P < .001; mean difference for symptoms, -1.1 [95% CI, -1.7 to -0.4]; P < .001). At 26 weeks, function for the yoga group remained superior (mean difference, -1.8 [95% CI, -3.1 to -0.5]; P < .001). Yoga was not superior to conventional stretching exercises at any time point. CONCLUSION Yoga classes were more effective than a self-care book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00447668.

Prevalence of Mammographically Dense Breasts in the United States

BACKGROUND National legislation is under consideration that would require women with mammographically dense breasts to be informed of their breast density and encouraged to discuss supplemental breast cancer screening with their health care providers. The number of US women potentially affected by this legislation is unknown. METHODS We determined the mammographic breast density distribution by age and body mass index (BMI) using data from 1518 599 mammograms conducted from 2007 through 2010 at mammography facilities in the Breast Cancer Surveillance Consortium (BCSC). We applied these breast density distributions to age- and BMI-specific counts of the US female population derived from the 2010 US Census and the National Health and Nutrition Examination Survey (NHANES) to estimate the number of US women with dense breasts. RESULTS Overall, 43.3% (95% confidence interval [CI] = 43.1% to 43.4%) of women 40 to 74 years of age had heterogeneously or extremely dense breasts, and this proportion was inversely associated with age and BMI. Based on the age and BMI distribution of US women, we estimated that 27.6 million women (95% CI = 27.5 to 27.7 million) aged 40 to 74 years in the United States have heterogeneously or extremely dense breasts. Women aged 40 to 49 years (N = 12.3 million) accounted for 44.3% of this group. CONCLUSION The prevalence of dense breasts among US women of common breast cancer screening ages exceeds 25 million. Policymakers and healthcare providers should consider this large prevalence when debating breast density notification legislation and designing strategies to ensure that women who are notified have opportunities to evaluate breast cancer risk and discuss and pursue supplemental screening options if deemed appropriate.

Diagnostic Accuracy of Digital Screening Mammography With and Without Computer-Aided Detection

IMPORTANCE After the US Food and Drug Administration (FDA) approved computer-aided detection (CAD) for mammography in 1998, and the Centers for Medicare and Medicaid Services (CMS) provided increased payment in 2002, CAD technology disseminated rapidly. Despite sparse evidence that CAD improves accuracy of mammographic interpretations and costs over

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini‐Sentinel pilot

400 million a year, CAD is currently used for most screening mammograms in the United States. OBJECTIVE To measure performance of digital screening mammography with and without CAD in US community practice. DESIGN, SETTING, AND PARTICIPANTS We compared the accuracy of digital screening mammography interpreted with (n = 495 818) vs without (n = 129 807) CAD from 2003 through 2009 in 323 973 women. Mammograms were interpreted by 271 radiologists from 66 facilities in the Breast Cancer Surveillance Consortium. Linkage with tumor registries identified 3159 breast cancers in 323 973 women within 1 year of the screening. MAIN OUTCOMES AND MEASURES Mammography performance (sensitivity, specificity, and screen-detected and interval cancers per 1000 women) was modeled using logistic regression with radiologist-specific random effects to account for correlation among examinations interpreted by the same radiologist, adjusting for patient age, race/ethnicity, time since prior mammogram, examination year, and registry. Conditional logistic regression was used to compare performance among 107 radiologists who interpreted mammograms both with and without CAD. RESULTS Screening performance was not improved with CAD on any metric assessed. Mammography sensitivity was 85.3% (95% CI, 83.6%-86.9%) with and 87.3% (95% CI, 84.5%-89.7%) without CAD. Specificity was 91.6% (95% CI, 91.0%-92.2%) with and 91.4% (95% CI, 90.6%-92.0%) without CAD. There was no difference in cancer detection rate (4.1 in 1000 women screened with and without CAD). Computer-aided detection did not improve intraradiologist performance. Sensitivity was significantly decreased for mammograms interpreted with vs without CAD in the subset of radiologists who interpreted both with and without CAD (odds ratio, 0.53; 95% CI, 0.29-0.97). CONCLUSIONS AND RELEVANCE Computer-aided detection does not improve diagnostic accuracy of mammography. These results suggest that insurers pay more for CAD with no established benefit to women.

Mediators of yoga and stretching for chronic low back pain.

This manuscript describes the current statistical methodology available for active postmarket surveillance of pre‐specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data.

Risk Factors for Inflammatory Breast Cancer and Other Invasive Breast Cancers

Although yoga is an effective treatment for chronic low back pain, little is known about the mechanisms responsible for its benefits. In a trial comparing yoga to intensive stretching and self-care, we explored whether physical (hours of back exercise/week), cognitive (fear avoidance, body awareness, and self-efficacy), affective (psychological distress, perceived stress, positive states of mind, and sleep), and physiological factors (cortisol, DHEA) mediated the effects of yoga or stretching on back-related dysfunction (Roland-Morris Disability Scale (RDQ)). For yoga, 36% of the effect on 12-week RDQ was mediated by increased self-efficacy, 18% by sleep disturbance, 9% by hours of back exercise, and 61% by the best combination of all possible mediators (6 mediators). For stretching, 23% of the effect was mediated by increased self-efficacy, 14% by days of back exercise, and 50% by the best combination of all possible mediators (7 mediators). In open-ended questions, ≥20% of participants noted the following treatment benefits: learning new exercises (both groups), relaxation, increased awareness, and the benefits of breathing (yoga), benefits of regular practice (stretching). Although both self-efficacy and hours of back exercise were the strongest mediators for each intervention, compared to self-care, qualitative data suggest that they may exert their benefits through partially distinct mechanisms.

Five-week outcomes from a dosing trial of therapeutic massage for chronic neck pain.

BACKGROUND We investigated risk factors for inflammatory breast cancer (IBC), a rare, aggressive, and poorly understood breast cancer that is characterized by diffuse breast skin erythema and edema. METHODS We included 617 IBC case subjects in a nested case-control study from the Breast Cancer Surveillance Consortium database (1994-2009). We also included 1151 noninflammatory, locally advanced, invasive breast cancers with chest wall/breast skin involvement (LABC), 7600 noninflammatory invasive case subjects without chest wall/breast skin involvement (BC), and 93 654 control subjects matched to case subjects on age and year at diagnosis and mammography registry. We present estimates of rate ratios (RRs) and 95% confidence intervals (CI) from conditional logistic regression analyses for each case group vs control subjects based on multiply imputed datasets. RESULTS First-degree family history of breast cancer and high mammographic breast density increased risk of IBC, LABC, and BC. High body mass index (BMI) increased IBC risk irrespective of menopausal status and estrogen receptor (ER) expression; rate ratios for BMI 30 and greater vs BMI less than 25 were 3.90 (95% CI = 1.50 to 10.14) in premenopausal women and 3.70 (95% CI = 1.98 to 6.94) in peri/postmenopausal women not currently using hormones. BMI 30 and greater slightly increased risk of ER-positive BC (RR = 1.40; 95% CI = 1.11 to 1.76). Statistically significant reductions in risk of ER-negative IBC with older age at first birth and of ER-positive IBC with higher education were not seen for LABC and BC of the same ER status. CONCLUSIONS Different associations with BMI, age at first birth, and education between IBC and/or LABC and BC suggest a distinct etiology for IBC.

Validity of Eight Integrated Healthcare Delivery Organizations' Administrative Clinical Data to Capture Breast Cancer Chemotherapy Exposure

PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0–50 points) and pain intensity with a numerical rating scale (range, 0–10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Disparities in the use of screening magnetic resonance imaging of the breast in community practice by race, ethnicity, and socioeconomic status.

Background: Cancer Research Network (CRN) sites use administrative data to populate their Virtual Data Warehouse (VDW). However, information on VDW chemotherapy data validity is limited. The purpose of this study was to assess the validity of VDW chemotherapy data. Methods: This was a retrospective cohort study of women ≥18 years with incident, invasive breast cancer diagnosed between January 1999 and December 2007. Pharmacy and procedure chemotherapy data were extracted from each sites VDW. Random samples of 50 patients stratified on trastuzumab, anthracyclines, and no chemotherapy exposure was selected from each site for detailed chart abstraction. Weighted sensitivities and specificities of VDW compared with abstracted data were calculated. Cumulative doses calculated from VDW data were compared with doses obtained from the medical chart review. Results: The cohort included 13,497 patients with 6,456 (48%) chart review eligible. Patients in the sample (N = 400) had a mean age of 65 years. Trastuzumab, anthracycline, and other chemotherapy weighted sensitivities were 95%, 97%, and 100%, respectively; specificities were 99%, 99%, and 93%, respectively; positive predictive values were 96%, 99%, and 55%, respectively; and negative predictive values were 99%, 96%, and 100%. Trastuzumab and anthracyclines VDW mean doses were 873 and 386 mg, respectively, whereas abstracted mean doses were 1,734 and 369 mgs, respectively (R2 = 0.14, P < 0.01 and R2 = 0.05, P = 0.03, respectively). Conclusions: Sensitivities and specificities for CRN chemotherapy VDW data were high and dosages were correlated with chart information. Impact: The findings support the use of CRN data in evaluating chemotherapy exposures and related outcomes. Cancer Epidemiol Biomarkers Prev; 21(4); 673–80. ©2012 AACR.

A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data

Uptake of breast magnetic resonance imaging (MRI) coupled with breast cancer risk assessment offers the opportunity to tailor the benefits and harms of screening strategies for women with differing cancer risks. Despite the potential benefits, there is also concern for worsening population‐based health disparities.