Chlamydia Prevalence by Age and Correlates of Infection Among Pregnant Women.

BACKGROUND: There is a paucity of population-based data on chlamydia in pregnancy despite rising rates in US women. Our objectives were to assess chlamydia prevalence by age group and to identify factors associated with infection in pregnant women to inform screening guidelines. METHODS: This cross-sectional study included pregnant women tested for chlamydia who delivered at the University of Alabama at Birmingham between November 1, 2012, and December 31, 2017. The primary outcome was chlamydia prevalence, defined as a positive urogenital chlamydia nucleic acid amplification test result documented in the electronic medical record. Multivariable logistic regression was used to identify factors associated with infection. RESULTS: Among 17,796 women who delivered during the study period, 13,657 (77%) had chlamydia testing performed at the University of Alabama at Birmingham. Chlamydia prevalence (95% confidence interval) was 7.4% (7.0%-7.9%). Age-stratified prevalence rates were 14.6%, 4.3%, and 1.7% for women younger than 25 years, 25 to 29 years, and 30 years or older, respectively. Chlamydia in pregnancy remained strongly associated with age (adjusted odds ratio [95% confidence interval], 7.2 [5.6-9.2] for age <25 years, and 2.3 [1.7-3.0] for ages 25-29 years, when compared with >30 years) after adjustment for race, urban residence, and insurance status. CONCLUSIONS: Among pregnant women living in the southeastern United States, chlamydia was detected in 1 of 14 women who were tested. Chlamydia positivity was highest among women younger than 30 years. Study findings support broad screening for chlamydia in pregnancy.

Duration of Bisphosphonate Drug Holidays and Associated Fracture Risk.

BACKGROUND: Discontinuation of bisphosphonates (BP) or a "drug holiday" after several years of treatment is increasingly common. However, the association of drug holiday duration with future fracture risk is unclear. OBJECTIVES: We evaluated the rate of fracture in relation to various lengths of drug holidays among women receiving long-term BP therapy. RESEARCH DESIGN: Observational cohort study using US Medicare data 2006-2016. Incidence rates (IRs) and Cox proportional hazards models were used to evaluate the rate and adjusted hazard ratios (aHRs) controlling for potential confounders. SUBJECTS: Women aged 65 years and above enrolled in fee-for-service Medicare who had been adherent (≥80%) to alendronate, risedronate, or zoledronate for ≥3 years. MEASURES: Hip, humerus, distal forearm, and clinical vertebral fracture. RESULTS: Among 81,427 eligible women observed for a median (interquartile range) of 4.0 (2.5, 5.3) years, 28% of women underwent a drug holiday. In the alendronate cohort (73% overall), the IR of hip fracture among women who discontinued BP for >2 years was 13.2 per 1000 person-years. Risk was increased (aHR=1.3, 1.1-1.4) versus continuing therapy (IR=8.8, referent). Rates were elevated for humerus fracture with discontinuation >2 years (aHR=1.3, 1.1-1.66) and for clinical vertebral fracture with discontinuation >2 years (aHR=1.2, 1.1-1.4). Results were similar for risedronate, zoledronate, and ibandronate for hip and clinical vertebral fracture. CONCLUSION: Discontinuing alendronate beyond 2 years was associated with increased risk of hip, humerus, and clinical vertebral fractures.

Changing rates in fracture trends are temporally associated with declining testing and treatment: reality or ecologic fallacy?

PURPOSE OF REVIEW: The changing patterns of osteoporosis treatment and fragility fractures have led to what leaders are calling a 'crisis in the osteoporosis.' We address data on changing patterns in fractures, and highlight strengths and limitations of recently published data. RECENT FINDINGS: Declines in hip fracture rates have been shown in studies from around the world. However, recently, using national Medicare data, Michael Lewiecki and colleagues show a plateau in the decline of hip fracture incidence in the United States from 2012 to 2015. Population-based data is integral for evaluating temporal trends; however, researchers must consider the biases associated with them including: age effects, period effects, and cohort effects. Rosengren and colleagues conducted the most comprehensive evaluation of age, period, and birth cohort effects in their study of hip fracture trends from 1987 to 2010 in Denmark and Sweden, in which they identified changes in hip fracture rates based on age, period, and cohort effects. SUMMARY: Recent findings show clear temporal trends in changing fracture rates. Studies, which evaluated these biases largely attribute increased hip fracture rates to various age, period, and cohort effects, highlighting the importance of appropriate screening and treatment.

Association of e-cigarette use with oral health: a population-based cross-sectional questionnaire study.

BACKGROUND: The impact of daily or intermittent electronic cigarette (e-cigarette) use on oral health is unknown. METHODS: We performed a cross-sectional analysis using the 2016 Behavioral Risk Factor Surveillance System data. Poor oral health was determined by the number of permanent teeth removed due to non-traumatic causes, and e-cigarette use determined by daily or intermittent use within 30 days prior to survey administration. We performed logistic regression analysis to test associations between e-cigarette use and oral health with adjustment for factors associated with poor oral health, survey clustering, strata and weight. RESULTS: We included survey responses from 456 343 adults. Over half of respondents (51.5%) reported having at least one permanent tooth removed because of tooth decay or gum disease in their lifetime. Daily e-cigarette use was reported by 4957 (1.1%) of respondents. In multivariable analysis, daily e-cigarette use, was independently associated with a 78% higher odds of poor oral health (adjusted OR = 1.78, 95% CI: 1.39-2.30; P < 0.001). CONCLUSIONS: In a population-based health survey of US adults, self-reported health behavior and outcomes, daily use, but not intermittent use of e-cigarettes was independently associated with poor oral health. Care must be exercised in seeking 'healthier' cigarette alternatives.

Characteristics of older adults using patient web portals to view their DXA results.

BACKGROUND: Sharing test results with patients via patient web portals is a new trend in healthcare. No research has been done examining patient web portal use with bone density test results. The objective of our study was to identify patient characteristics associated with the use of patient web portals to view their bone density test results. METHODS: A secondary analysis of data from a pragmatic randomized controlled trial of 7749 participants ≥50 years old that had presented for a dual energy X-ray absorptiometry (DXA) bone density test. Patients were interviewed at enrollment and 12 weeks later. Multivariable logistic regression identified patient characteristics that differentiated those who used the web portal from those who did not. RESULTS: Our sample included 4669 patients at the two (University of Iowa [UI], and Kaiser Permanente of Georgia [KPGA]) clinical sites that had patient web portals. Of these patients, 3399 (72.8%) reported knowing their test results 12 weeks post-DXA, with 649 (13.9%) reporting that they viewed their DXA results using the web portal. Web portal users were more likely to be from UI than KPGA, and were younger, more educated, had higher health literacy, had osteopenia, and had the same sex as their referring physician (all p < 0.05). CONCLUSION: Only 19.1% of the 3399 patients who knew their DXA results used the available patient web portals to find out about them. Web portal users differed from non-users on several characteristics. This suggests that simply making patient web portals available for use may not be sufficient to appreciably enhance patient awareness of their test results. Based on these findings, a better understanding of the reasons why older, less educated, and less activated patients do not access their test results through patient web portals is needed.

Disparities in receipt of follow-up care instructions among female adult cancer survivors: Results from a national survey.

OBJECTIVE: To evaluate predictors of receipt of follow-up instructions at completion of cancer treatment among women with breast and gynecologic cancers (cervical, endometrial, ovarian) in the United States, and determine if the factors differ by cancer type. METHODS: We designed a cross-sectional study using data from the "Cancer Survivorship" module of the 2016 Behavioral Risk Factor Surveillance System (BRFSS). We created logistic regression models to determine characteristics associated with receipt of follow-up care instructions, and stratified by models by cancer type to evaluate differences in factors. RESULTS: Our sample included 954 (66%) and 492 (34%) women with breast and gynecologic cancers respectively. Even after adjustment, women treated for gynecologic cancer had 63% lower odds [0.37 (0.25-0.55)] of receiving follow-up instructions compared to women with breast cancer. Among breast cancer patients, those with an income <$25,000 per year had lower odds of receiving follow-up instructions [0.53(0.31-0.92)], while patients with high BMI (BMI ≥30 kg/m2) had higher odds of receiving follow-up instructions [1.91 (1.15-3.18)]. Among gynecologic cancer patients, those diagnosed 51-75 years had higher odds of receiving follow-up instructions compared to those diagnosed ≤50 years [2.54 (1.13-5.70)]. CONCLUSION: In our study, gynecologic cancer patients less frequently received follow-up instructions compared to breast cancer patients. Receipt of follow-up instructions also differed by demographic and lifestyle factors. The results provide evidence for the need of public health initiatives to increase the frequency of follow-up instructions for gynecologic cancer patients, which can potentially increase the rate of follow-up and improve long-term outcomes.

Racial Differences and Disparities in Osteoporosis-related Bone Health: Results From the PAADRN Randomized Controlled Trial.

BACKGROUND: Determining whether observed differences in health care can be called disparities requires persistence of differences after adjustment for relevant patient, provider, and health system factors. We examined whether providing dual-energy x-ray absorptiometry (DXA) test results directly to patients might reduce or eliminate racial differences in osteoporosis-related health care. DESIGN, SUBJECTS, AND MEASURES: We analyzed data from 3484 white and 1041 black women who underwent DXA testing at 2 health systems participating in the Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial (ClinicalTrials.gov NCT-01507662) between February 2012 and August 2014. We examined 7 outcomes related to bone health at 12 weeks and 52 weeks post-DXA: (1) whether the patient correctly identified their DXA baseline results; (2) whether the patient was on guideline-concordant osteoporosis pharmacotherapy; (3) osteoporosis-related satisfaction; (4) osteoporosis knowledge; (5 and 6) osteoporosis self-efficacy for exercise and for diet; and (7) patient activation. We examined whether unadjusted differences in outcomes between whites and blacks persisted after adjusting for patient, provider, and health system factors. RESULTS: Mean age was 66.5 years and 29% were black. At baseline black women had less education, poorer health status, and were less likely to report a history of osteoporosis (P<0.001 for all). In unadjusted analyses black women were less likely to correctly identify their actual DXA results, more likely to be on guideline-concordant therapy, and had similar patient activation. After adjustment for patient demographics, baseline health status and other factors, black women were still less likely to know their actual DXA result and less likely to be on guideline-concordant therapy, but black women had greater patient activation. CONCLUSIONS: Adjustment for patient and provider level factors can change how racial differences are viewed, unmasking new disparities, and providing explanations for others.

Improving medical record retrieval for validation studies in Medicare data.

PURPOSE: The purpose of the study is to describe medical record retrieval for a study validating claims-based algorithms used to identify seven adverse events of special interest (AESI) in a Medicare population. METHODS: We analyzed 2010-2011 Medicare claims of women with postmenopausal osteoporosis and men ≥65 years of age in the Medicare 5% national sample. The final cohorts included beneficiaries covered continuously for 12+ months by Medicare parts A, B, and D and not enrolled in Medicare Advantage before starting follow-up. We identified beneficiaries using each AESI algorithm and randomly selected 400 women and 100 men with each AESI for medical record retrieval. The Centers for Medicare and Medicaid Services provided beneficiary contact information, and we requested medical records directly from providers, without patient contact. RESULTS: We selected 3331 beneficiaries (women: 2272; men: 559) for whom we requested 3625 medical records. Overall, we received 1738 [47.9% (95%CI 46.3%, 49.6%)] of the requested medical records. We observed small differences in the characteristics of the total population with AESIs compared with those randomly selected for retrieval; however, no differences were seen between those selected and those retrieved. We retrieved 54.7% of records requested from hospitals compared with 26.3% of records requested from physician offices (p < 0.001). Retrieval did not differ by sex or vital status of the beneficiaries. CONCLUSIONS: Our national medical record validation study of claims-based algorithms produced a modest retrieval rate. The medical record procedures outlined in this paper could have led to the improved retrieval from our previous medical record retrieval study. Copyright © 2016 John Wiley & Sons, Ltd.

Activating Patients With a Tailored Bone Density Test Results Letter and Educational Brochure: the PAADRN Randomized Controlled Trial.

In cross-sectional studies, patient activation has been associated with better health behaviors, health outcomes, and health-care experiences. Moreover, tailored interventions have led to clinically meaningful improvements in patient activation, as well as health outcomes over time. We tested whether a tailored patient-activation letter communicating bone mineral density (BMD) test results plus an educational brochure improved patient activation scores and levels at 12 and 52 wk post-baseline as the mechanism leading to enhanced bone healthcare. In a randomized, controlled, double-blinded, multicenter pragmatic clinical trial, we randomized 7749 patients ≥50 yr old and presenting for BMD testing at 3 medical centers in the United States between February 2012 and August 2014. The outcome measures were patient activation scores and levels based on 6 items taken from the Patient Activation Measure (PAM) that were administered at the baseline, 12-wk, and 52-wk follow-up interviews. Mean age was 66.6 yr, 83.8% were women, and 75.3% were Non-Hispanic-Whites. Overall, PAM activation scores improved from 58.1 at baseline to 76.4 by 12 wk (p < 0.001) and to 77.2 (p = 0.002) by 52 wk post-baseline. These improvements, however, were not significantly different between the intervention and usual care groups (18.7 vs 18.1, p = 0.176, at 12 wk) in intention-to-treat analyses. PAM activation scores and levels substantially improved at 12 wk and 52 wk, but no differences were observed in these improvements between the intervention and usual care groups. These null findings may have occurred because the tailoring focused on the patient's BMD and fracture risk results, rather than on the patient's BMD and fracture risk results as well as the patient's baseline PAM activation scores or levels.

Patient-reported reasons for nonadherence to recommended osteoporosis pharmacotherapy.

OBJECTIVES: As many as one-half of patients recommended for osteoporosis pharmacotherapy do not take their medications. To identify intervention targets, we examined patient characteristics associated with nonadherence to recommended pharmacotherapy and their reasons for nonadherence. METHODS: Data come from the Patient Activation after DXA Result Notification (PAADRN) study, a randomized controlled trial of 7749 patients aged 50 years or older presenting for dual-energy X-ray absorptiometry (DXA) at 3 health centers in the United States. We focused on the 790 patients who reported receiving a recommendation for new pharmacotherapy at baseline. Using Pearson chi-squared tests for categorical variables, 2-sample t tests for continuous variables, and multivariable multinomial logistic regression, we compared those who reported starting the recommended medication (adherers) with temporary nonadherers and nonadherers on demographics, health habits, DXA impression, 10-year probability of fracture using the assessment tool, and osteoporosis knowledge, and we examined their stated reasons for nonadherence. RESULTS: Mean age was 66.8 years (SD = 8.9); 87.2% were women, and 84.2% were white. One-fourth of patients (24.8%) reported that they did not start their recommended pharmacotherapy. In the unadjusted analyses, the only factor significantly associated with nonadherence was osteoporosis knowledge, with those having better knowledge being less likely to take their medications (P < 0.05). The most common reasons for nonadherence were fear of adverse effects (53.3%), a dislike of taking medicine (25.3%), and the belief that the medication would not help their condition (16.7%). CONCLUSION: One in 4 patients recommended for osteoporosis pharmacotherapy declined treatment because they feared potential adverse effects, did not like taking medicine, or believed that the medication would not help their condition. Improved patient counseling on the potential adverse effects of osteoporosis treatment and the risk-benefit ratio for these medications may increase adherence.

Effects of a DXA result letter on satisfaction, quality of life, and osteoporosis knowledge: a randomized controlled trial.

BACKGROUND: Undiagnosed, or diagnosed and untreated osteoporosis (OP) increases the likelihood that falls result in hip fractures, decreased quality of life (QOL), and significant medical expenditures among older adults. We tested whether a tailored dual energy x-ray absorptiometry (DXA) test result letter and an accompanying educational bone-health brochure affected patient satisfaction, QOL, or OP knowledge. METHODS: The Patient Activation after DXA Result Notification (PAADRN) study was a double-blinded, pragmatic, randomized trial which enrolled patients from 2012 to 2014. We randomized 7,749 patients presenting for DXA at three health care institutions in the United States who were ≥ 50 years old and able to understand English. Intervention patients received a tailored letter four weeks after DXA containing their results, 10-year fracture risk, and a bone-health educational brochure. Control patients received the results of their DXA per the usual practices of their providers and institutions. Satisfaction with bone health care, QOL, and OP knowledge were assessed at baseline and 12- and 52-weeks after DXA. Intention-to-treat analyses used multiple imputation for missing data and random effects regression models to adjust for clustering within providers and covariates. RESULTS: At 12-weeks 6,728 (86.8 %) and at 52-weeks 6,103 participants (78.8 %) completed their follow-up interviews. The intervention group was more satisfied with their bone health care compared to the usual care group at both their 12- and 52-week follow-ups (standardized effect size = 0.28 at 12-weeks and 0.17 at 52-weeks, p < 0.001). There were no differences between the intervention and usual care groups in QOL or OP knowledge at either time point. CONCLUSIONS: A tailored DXA result letter and bone-health educational brochure sent to patients improved patient satisfaction with bone-related health care. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01507662 First received: December 8, 2011.

Validation study of medicare claims to identify older US adults with CKD using the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study.

BACKGROUND: Health care claims data may provide a cost-efficient approach for studying chronic kidney disease (CKD). STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: We compared characteristics and outcomes for individuals with CKD defined using laboratory measurements versus claims data from 6,982 REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study participants who had Medicare fee-for-service coverage. PREDICTORS: Presence of CKD as defined by both the REGARDS Study (CKDREGARDS) and Medicare data (CKDMedicare), presence of CKDREGARDS but not CKDMedicare, and presence of CKDMedicare but not CKDREGARDS, and absence of both CKDREGARDS and CKDMedicare. OUTCOMES: Mortality and incident end-stage renal disease (ESRD). MEASUREMENTS: The research study definition of CKD (CKDREGARDS) included estimated glomerular filtration rate (eGFR) < 60mL/min/1.73m(2) or albumin-creatinine ratio > 30mg/g at the REGARDS Study visit. CKD in Medicare (CKDMedicare) was identified during the 2 years before each participant's REGARDS visit using a claims-based algorithm. RESULTS: Overall, 32% of participants had CKDREGARDS and 6% had CKDMedicare. Sensitivity, specificity, and positive and negative predictive values of CKDMedicare for identifying CKDREGARDS were 15.5% (95% CI, 14.0%-17.1%), 97.7% (95% CI, 97.2%-98.1%), 75.6% (95% CI, 71.4%-79.5%), and 71.5% (95% CI, 70.4%-72.6%), respectively. Mortality and ESRD incidence rates, expressed per 1,000 person-years, were higher for participants with versus without CKDMedicare (mortality: 72.5 [95% CI, 61.3-83.7] vs 33.3 [95% CI, 31.5-35.2]; ESRD: 16.4 [95% CI, 11.2-21.6] vs 1.3 [95% CI, 0.9-1.6]) and with versus without CKDREGARDS (mortality: 59.9 [95% CI, 55.4-64.4] vs 25.5 [95% CI, 23.6-27.4]; ESRD: 6.8 [95% CI, 5.4-8.3] vs 0.1 [95% CI, 0.0-0.3]). Among participants with CKDREGARDS, those with abdominal obesity, diabetes, anemia, lower eGFR, more outpatient visits, hospitalization, and a nephrologist visit in the 2 years before their REGARDS visit were more likely to have CKDMedicare. LIMITATIONS: CKDREGARDS relied on eGFR and albuminuria assessed at a single visit. CONCLUSIONS: CKD, whether defined in claims or through research study measurements, was associated with increased mortality and ESRD. However, individuals with CKD identified in claims may represent a select high-risk population.

Use of health plan combined with registry data to predict clinical trial recruitment.

BACKGROUND: Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. METHODS: Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients' treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. RESULTS: Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. CONCLUSION: Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

Patterns and predictors of osteoporosis medication discontinuation and switching among Medicare beneficiaries.

BACKGROUND: Low adherence to bisphosphonate therapy is associated with increased fracture risk. Factors associated with discontinuation of osteoporosis medications have not been studied in-depth. This study assessed medication discontinuation and switching patterns among Medicare beneficiaries who were new users of bisphosphonates and evaluated factors possibly associated with discontinuation. METHODS: We identified patients initiating bisphosphonate treatment using a 5% random sample of Medicare beneficiaries with at least 24 months of traditional fee-for-service and part D drug coverage from 2006 through 2009. We classified medication status at the end of follow-up as: continued original bisphosphonate, discontinued without switching or restarting, restarted the same drug after a treatment gap (≥ 90 days), or switched to another anti-osteoporosis medication. We conducted logistic regression analyses to identify baseline characteristics associated with discontinuation and a case-crossover analysis to identify factors that precipitate discontinuation. RESULTS: Of 21,452 new users followed respectively for 12 months, 44% continued their original therapy, 36% discontinued without switching or restarting, 8% restarted the same drug after a gap greater than 90 days, and 11% switched to another anti-osteoporosis medication. Factors assessed during the 12-month period before initiation were weakly associated with discontinuation. Several Factors measured during follow-up were associated with discontinuation, including more physician visits, hospitalization, having a dual-energy X-ray absorptiometry test, higher Charlson comorbidity index scores, higher out-of-pocket drug payments, and upper gastrointestinal problems. Patterns were similar for 4,738 new users followed for 30 months. CONCLUSIONS: Among new bisphosphonates users, switching within and across drug classes and extended treatment gaps are common. Robust definitions and time-varying considerations should be considered to characterize medication discontinuation more accurately.

Improving bone mineral density reporting to patients with an illustration of personal fracture risk.

BACKGROUND: To determine patients' preferences for, and understanding of, FRAX® fracture risk conveyed through illustrations. METHODS: Drawing on examples from published studies, four illustrations of fracture risk were designed and tested for patient preference, ease of understanding, and perceived risk. We enrolled a convenience sample of adults aged 50 and older at two medical clinics located in the Midwestern and Southern United States. In-person structured interviews were conducted to elicit patient ranking of preference, ease of understanding, and perceived risk for each illustration. RESULTS: Most subjects (n = 142) were female (64%), Caucasian (76%) and college educated (78%). Of the four risk depictions, a plurality of participants (37%) listed a bar graph as most preferred. Subjects felt this illustration used the stoplight color system to display risk levels well and was the most "clear," "clean," and "easy to read". The majority of subjects (52%) rated the pictogram as the most difficult to understand as this format does not allow people to quickly ascertain their individual risk category. CONCLUSIONS: Communicating risk to patients with illustrations can be done effectively with clearly designed illustrations responsive to patient preference. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01507662.

The American Society for Bone and Mineral Research Task Force on clinical algorithms for fracture risk report.

Using race and ethnicity in clinical algorithms potentially contributes to health inequities. The American Society for Bone and Mineral Research (ASBMR) Professional Practice Committee convened the ASBMR Task Force on Clinical Algorithms for Fracture Risk to determine the impact of race and ethnicity adjustment in the US Fracture Risk Assessment Tool (US-FRAX). The Task Force engaged the University of Minnesota Evidence-based Practice Core to conduct a systematic review investigating the performance of US-FRAX for predicting incident fractures over 10 years in Asian, Black, Hispanic, and White individuals. Six studies from the Women's Health Initiative (WHI) and Study of Osteoporotic Fractures (SOF) were eligible; cohorts only included women and were predominantly White (WHI > 80% and SOF > 99%), data were not consistently stratified by race and ethnicity, and when stratified there were far fewer fractures in Black and Hispanic women vs White women rendering area under the curve (AUC) estimates less stable. In the younger WHI cohort (n = 64 739), US-FRAX without bone mineral density (BMD) had limited discrimination for major osteoporotic fracture (MOF) (AUC 0.53 (Black), 0.57 (Hispanic), and 0.57 (White)); somewhat better discrimination for hip fracture in White women only (AUC 0.54 (Black), 0.53 (Hispanic), and 0.66 (White)). In a subset of the older WHI cohort (n = 23 918), US-FRAX without BMD overestimated MOF. The Task Force concluded that there is little justification for estimating fracture risk while incorporating race and ethnicity adjustments and recommends that fracture prediction models not include race or ethnicity adjustment but instead be population-based and reflective of US demographics, and inclusive of key clinical, behavioral, and social determinants (where applicable). Research cohorts should be representative vis-à-vis race, ethnicity, gender, and age. There should be standardized collection of race and ethnicity; collection of social determinants of health to investigate impact on fracture risk; and measurement of fracture rates and BMD in cohorts inclusive of those historically underrepresented in osteoporosis research.

Using race or ethnicity when calculating disease risk may contribute to health disparities. The ASBMR Task Force on Clinical Algorithms for Fracture Risk was created to understand the impact of the US Fracture Risk Assessment Tool (US-FRAX) race and ethnicity adjustments. The Task Force reviewed the historical development of FRAX, including the assumptions underlying selection of race and ethnicity adjustment factors. Furthermore, a systematic review of literature was conducted, which revealed an overall paucity of data evaluating the performance of US-FRAX in racially and ethnically diverse groups. While acknowledging the existence of racial and ethnic differences in fracture epidemiology, the Task Force determined that currently there is limited evidence to support the use of race and ethnicity­specific adjustments in US-FRAX. The Task Force also concluded that research is needed to create generalizable fracture risk calculators broadly applicable to current US demographics, which do not include race and ethnicity adjustments. Until such population­based fracture calculators are available, clinicians should consider providing fracture risk ranges for Asian, Black, and/or Hispanic patients and should engage in shared decision-making with patients about fracture risk interpretation. Future studies are required to evaluate fracture risk tools in populations inclusive of those historically underrepresented in research.

Study design considerations for a large simple trial of bisphosphonates.

PURPOSE OF REVIEW: To evaluate design considerations for an osteoporosis large simple trial (LST). RECENT FINDINGS: There is a growing need for more comparative effectiveness studies in osteoporosis. However, the design of such studies is challenged by issues surrounding study design, choosing comparator therapies, participant and outcome selection, data acquisition and data analysis. SUMMARY: LSTs are real-world studies that can have high levels of generalizability, if designed properly. We propose novel approaches to LSTs focusing on some of the challenges associated with comparative effectiveness research in osteoporosis. In this review, we discuss these considerations in the context of bisphosphonate active comparator initiation and discontinuation trials, while presenting advantages and disadvantages of the various design aspects for such studies.

Identifying newly approved medications in Medicare claims data: a case study using tocilizumab.

BACKGROUND: After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described. OBJECTIVES: To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010. METHODS: We used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity. RESULTS: Of 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100). CONCLUSION: Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes.

The Consumption of Animal and Plant Foods in Areas of High Prevalence of Stroke and Colorectal Cancer.

Diets of red and processed meat have been reported as important risk factors for developing colorectal cancer. Given the racial and ethnic differences in the incidence of colorectal cancer, patterns of food consumption, and areas of residence, particularly in the South, more data is needed on the relationship between residing in a high stroke area, colorectal cancer incidence levels, and red meat and processed meat consumption. We created online surveys to ascertain meat, red meat, and healthy food consumption levels. We used OLS regression to evaluate the association between residence in Stroke Belt states and colorectal cancer incidence quartiles with food consumption. We further used path analysis using structural equation modeling to evaluate if age, sex, race/ethnicity, income, and comorbidity index mediated the association between residence in the eight-state Stroke Belt, colorectal cancer incidence groups, and meat consumption. Our sample included 923 participants, with 167 (18.1%) residing in the Stroke Belt and 13.9% being in the highest colorectal cancer incidence group. The findings show that residing in a Stroke Belt state is predictive of the consumption of overall meat 0.93 more days per week or red meat 0.55 more days per week compared to those not residing in a Stroke Belt state. These data can be used to develop future diet interventions in these high-risk areas to reduce rates of colorectal cancer and other negative health outcomes.

From fracture risk prediction to evaluating fracture patterns: recent advances in the epidemiology of osteoporosis.

Understanding the factors associated with fracture is one of the main research objective of the osteoporosis epidemiology field. Tools such as FRAX have overall improved the ability of clinicians and researchers to identify individuals at high risk of fragility fractures. However, the performance of these tools in specific subpopulations needs further examination. We highlight recent studies that have shown under- or overestimation of fractures using FRAX in subpopulations, as well as recently proposed modifications to this important algorithm. We also discuss recent evaluations of secular trends in fracture incidence.