Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.

BACKGROUND: NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America. METHODS: We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed. RESULTS: Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose. CONCLUSIONS: NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).

Comparison of circulating and excreted metals and of autoimmunity between two Great Plains Tribal communities.

Metals contaminants of the environment from mine waste have been implicated as contributing agents in autoimmune disease. The current study compares metals and autoimmunity in two Tribal communities residing in the Black Hills and the Bighorn Mountains geographical regions that are scattered with extant hard rock mines. With documented drinking water contamination in both communities, in vivo levels of more than half of the measured serum and urine metals differed between the two communities and were substantially different from their national median values. Serum autoantibodies associated with systemic autoimmune disease were rare or at low-level, but antibodies to denatured (single-stranded) DNA and thyroid-specific autoantibodies were commonly elevated, especially in women. A three-tier statistical modeling process was carried out to examine individual metals exposure as predictors of autoantibody levels. For the most part only weak positive associations between individual metals and systemic autoantibodies were found, although univariate quantile regression analysis showed positive statistical associations of serum lead and antimony with anti-chromatin and anti-histone autoantibodies. Using age and gender-adjusted multivariable statistical models, metals did not predict anti-thyroglobulin or -thyroid peroxidase significantly and metals were generally negative predictors of the other autoantibodies. Overall these results suggest that elevated levels of environmental metals and metalloids in these communities may result in suppression of autoantibodies associated with systemic autoimmune disease.

Active smoking, secondhand smoke exposure and serum cotinine levels among Cheyenne River Sioux communities in context of a Tribal Public Health Policy.

INTRODUCTION: American Indians and Alaska Natives face disproportionately high rates of smoking and secondhand smoke (SHS) exposure. The Cheyenne River Sioux Tribe (CRST) is among the few Tribal Nations controlling commercial tobacco exposures in public and work places. We had an opportunity to explore effects of the new commercial tobacco-free policy (implemented in 2015) in an environmental health study (2014-2016) that collected information about commercial tobacco use and SHS prevalence and examined predictor variables of serum cotinine concentrations. METHODS: Self-reported survey data were used in quantile regression statistical modelling to explore changes in cotinine levels, based on smoking status, smokeless tobacco consumption and SHS exposure. RESULTS: From enrolled 225 adults, 51% (N=114) were current smokers. Among 88 non-tobacco users, 35 (40%) reported current SHS exposure. Significant differences in cotinine median concentrations were found among participants with and without current SHS exposure. Extremely high cotinine concentrations (~100 times larger than the median) were detected in some non-tobacco users. After implementing the new smoke-free air Tribal policy, cotinine decreased in participants with intermediate (3-15 ng/mL, non-tobacco users with SHS exposure) and high (>15 ng/mL, mainly tobacco users) cotinine levels showing association with an abatement of opportunities for SHS exposure. Significant predictors of cotinine levels were sampling year, current smoking and tobacco chewing. No gender differences were observed in cotinine. CONCLUSIONS: Our results show decrease in cotinine concentrations in CRST participants since implementation of their 'Smoke-Free Clean Air Act' in 2015.

Type 2 diabetes and later cognitive function in older American Indians: The Strong Heart Study.

OBJECTIVES: Insulin resistance is a substantial health issue for American Indians, with type 2 diabetes overrepresented in this population as compared with non-Hispanic whites. Insulin resistance and its related conditions in turn increase risk for dementia and cognitive impairment. The aim of the current study was to determine whether type 2 diabetes and insulin resistance at midlife was associated with later-life cognitive testing in a large sample of older American Indians, aged 65 and older. METHODS: American Indian participants who underwent both fasting blood draw as part of the Strong Heart Study and had subsequent cognitive testing as part of the later adjunct Cerebrovascular Disease and its Consequences in American Indians study were included (n = 790). Regression models examined type 2 diabetes and impaired fasting glucose and subsequent cognitive test performance as part of a longitudinal study design. The relationship between a continuous measure of insulin resistance and later cognitive test performance was assessed using generalized estimating equations. RESULTS: Controlling for demographic and clinical factors, verbal fluency and processing speed/working memory were significantly negatively associated with having type 2 diabetes and with insulin resistance, but not with impaired fasting glucose. CONCLUSION: In this sample of American Indians, type 2 diabetes at midlife was associated with subsequent lower performance on measures of executive function. These results may have important implications for future implementation of diagnostic and intervention services in this population.

Spatial Epidemiology of Alcohol- and Drug-Related Health Problems Among Northern Plains American Indians: Nebraska and South Dakota, 2007 to 2012.

BACKGROUND: Despite high abstinence rates, American Indians experience elevated rates of many alcohol and other drug problems. American Indians also predominantly reside in poor and rural areas, which may explain some observed health disparities. We investigated whether geographic areas including reservations or large American Indian populations exhibited greater incidence of alcohol- and drug-related hospitalizations. METHODS: We obtained inpatient hospitalization records for 2 Northern Plain states (Nebraska and South Dakota) for the years 2007 to 2012. We constructed zip code counts for 10 categories of hospitalization with diagnoses or injury causation commonly associated with alcohol or drug use. We related these to community sociodemographic characteristics using Bayesian Poisson space-time regression models and examined associations with and without controls for whether each zip code was located within an American Indian reservation. RESULTS: Controlling for other demographic and economic characteristics, zip codes with greater percentage of American Indians exhibited greater incidence for all 10 substance abuse-related health outcomes (9 of 10 well supported); zip code areas within American Indian reservations had greater incidence of self-inflicted injury and drug dependence and abuse, and reduced incidence of alcohol cirrhosis and prescription opioid poisoning. However, the analyses generally demonstrated no well-supported differences in incidence associated with local residence percentages of American Indian versus African American. CONCLUSIONS: In our analyses, ethnicity or heredity alone did not account for alcohol- and drug-related hospitalizations among Native populations. Aspects of social, economic, and political dimensions of Native lives must be considered in the etiology of alcohol- and drug-related problems for rural-dwelling indigenous peoples.

Relationships Between Smoking Behaviors and Cotinine Levels Among Two American Indian Populations With Distinct Smoking Patterns.

Introduction: Smoking prevalence, cigarettes per day (CPD), and lung cancer incidence differ between Northern Plains (NP) and Southwest (SW) American Indian populations. We used cotinine as a biomarker of tobacco smoke exposure to biochemically characterize NP and SW smokers and nonsmokers and to investigate factors associated with variation in tobacco exposure. Methods: American Indians (N = 636) were recruited from two different tribal populations (NP and SW) as part of a study conducted as part of the Collaborative to Improve Native Cancer Outcomes P50 project. For each participant, a questionnaire assessed smoking status, CPD, second-hand smoke exposure, and traditional ceremonial tobacco use; plasma and/or salivary cotinine was measured. Results: Cotinine levels were (mean ± 95% confidence interval [CI]) 81.6 ± 14.1 and 21.3 ± 7.3 ng/ml among NP smokers and non-mokers, respectively, and 44.8 ± 14.4 and 9.8 ± 5.8 ng/ml among SW smokers and nonsmokers, respectively. Cotinine levels correlated with CPD in both populations (p < .0001). Cotinine ≥15 ng/ml was measured in 73.4% of NP smokers and 47.8% of SW smokers and in 19.0% of NP nonsmokers and 10.9% of SW nonsmokers. Ceremonial traditional tobacco use was associated with higher cotinine among NP smokers only (p = 0.004). Second-hand smoke exposure was associated with higher cotinine among NP non-smokers (P < 0.02). More secondhand smoke exposure was associated with smoking more CPD in both populations (p = 0.03-0.29). Linear regression modeling mirrored these findings. Conclusions: High prevalence of smoking in the Northern Plains and high cotinine levels among nonsmokers in both regions highlights the tribal populations' risk for tobacco-related disease. Implications: There is a high prevalence of smoking in Northern Plains American Indians. Among Northern Plains and Southwest nonsmokers, relatively high cotinine levels, representative of high tobacco exposure, suggest considerable exposure to second-hand smoke. It is critical to highlight the extent of second-hand smoke exposure among the Northern Plains and Southwest American Indians and to enhance efforts to initiate smoke-free policies in tribal communities, which are not subject to state-level polices.

Variation in CYP2A6 and nicotine metabolism among two American Indian tribal groups differing in smoking patterns and risk for tobacco-related cancer.

OBJECTIVE: The Northern Plains (NP) and Southwest (SW) American Indian populations differ in their smoking patterns and lung cancer incidence. We aimed to compare CYP2A6 genetic variation and CYP2A6 enzyme activity (representative of the rate of nicotine metabolism) between the two tribal populations as these have previously been associated with differences in smoking, quitting, and lung cancer risk. PARTICIPANTS AND METHODS: American Indians (N=636) were recruited from two different tribal populations (NP in South Dakota, SW in Arizona) as part of a study carried out as part of the Collaborative to Improve Native Cancer Outcomes P50 Project. A questionnaire assessed smoking-related traits and demographics. Participants were genotyped for CYP2A6 genetic variants *1B, *2, *4, *7, *9, *12, *17, and *35. Plasma and/or saliva samples were used to measure nicotine's metabolites cotinine and 3'-hydroxycotinine and determine CYP2A6 activity (3'-hydroxycotinine/cotinine, i.e. the nicotine metabolite ratio, NMR). RESULTS: The overall frequency of genetically reduced nicotine metabolizers, those with CYP2A6 decrease-of-function or loss-of-function alleles, was lower in the NP compared with the SW (P=0.0006). The CYP2A6 genotype was associated with NMR in both tribal groups (NP, P<0.0001; SW, P=0.04). Notably, the rate of nicotine metabolism was higher in NP compared with SW smokers (P=0.03), and in comparison with other ethnic groups in the USA. Of the variables studied, the CYP2A6 genotype was the only variable to significantly independently influence NMR among smokers in both tribal populations (NP, P<0.001; SW, P=0.05). CONCLUSION: Unique CYP2A6 allelic patterns and rates of nicotine metabolism among these American Indian populations suggest different risks for smoking, and tobacco-related disease.

Strengthening breast and cervical cancer control through partnerships: American Indian and Alaska Native Women and the National Breast and Cervical Cancer Early Detection Program.

The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) has played a critical role in providing cancer screening services to American Indian and Alaska Native (AI/ANs) women and strengthening tribal screening capacity. Since 1991, the NBCCEDP has funded states, tribal nations, and tribal organizations to develop and implement organized screening programs. The ultimate goal is to deliver breast and cervical cancer screening to women who do not have health insurance and cannot afford to pay for these services. The delivery of clinical services is supported through complementary program efforts such as professional development, public education and outreach, and patient navigation. This article seeks to describe the growth of NBCCEDP's tribal commitment and the unique history and aspects of serving the AI/AN population. The article describes: 1) how this program has demonstrated success in improving screening of AI/AN women; 2) innovative partnerships with the Indian Health Service, state programs, and other organizations that have improved tribal public health infrastructure; and 3) the evolution of Centers for Disease Control and Prevention work with tribal communities.

Historical trends and regional differences in all-cause and amenable mortality among American Indians and Alaska Natives since 1950.

American Indian and Alaska Native (AI/AN) death rates declined over most of the 20th century, even before the Public Health Service became responsible for health care in 1956. Since then, rates have declined further, although they have stagnated since the 1980s. These overall patterns obscure substantial regional differences. Most significant, rates in the Northern and Southern Plains have declined far less since 1949 to 1953 than those in the East, Southwest, or Pacific Coast. Data for Alaska are not available for the earlier period, so its trajectory of mortality cannot be ascertained. Socioeconomic measures do not adequately explain the differences and rates of change, but migration, changes in self-identification as an AI/AN person, interracial marriage, and variations in health care effectiveness all appear to be implicated.

Prostate cancer deaths and incident cases among American Indian/Alaska Native men, 1999-2009.

OBJECTIVES: We linked databases to improve identification of American Indians/Alaska Natives (AI/ANs) in determining prostate cancer death and incidence rates. METHODS: We linked prostate cancer mortality and incidence data with Indian Health Service (IHS) patient records; analyses focused on residents of IHS Contract Health Service Delivery Area (CHSDA) counties. We calculated age-adjusted incidence and death rates for AI/AN and White men for 1999 to 2009; men of Hispanic origin were excluded. RESULTS: Prostate cancer death rates were higher for AI/AN men than for White men. Death rates declined for White men (-3.0% per year) but not for AI/AN men. AI/AN men had lower prostate cancer incidence rates than White men. Incidence rates declined among Whites (-2.2% per year) and AI/ANs (-1.9% per year). CONCLUSIONS: AI/AN men had higher prostate cancer death rates and lower prostate cancer incidence rates than White men. Disparities in accessing health care could contribute to mortality differences, and incidence differences could be related to lower prostate-specific antigen testing rates among AI/AN men.

Trends and disparities in heart disease mortality among American Indians/Alaska Natives, 1990-2009.

OBJECTIVES: We evaluated heart disease death rates among American Indians and Alaska Natives (AI/ANs) and Whites after improving identification of AI/AN populations. METHODS: Indian Health Service (IHS) registration data were linked to the National Death Index for 1990 to 2009 to identify deaths among AI/AN persons aged 35 years and older with heart disease listed as the underlying cause of death (UCOD) or 1 of multiple causes of death (MCOD). We restricted analyses to IHS Contract Health Service Delivery Areas and to non-Hispanic populations. RESULTS: Heart disease death rates were higher among AI/AN persons than Whites from 1999 to 2009 (1.21 times for UCOD, 1.30 times for MCOD). Disparities were highest in younger age groups and in the Northern Plains, but lowest in the East and Southwest. In AI/AN persons, MCOD rates were 84% higher than UCOD rates. From 1990 to 2009, UCOD rates declined among Whites, but only declined significantly among AI/AN persons after 2003. CONCLUSIONS: Analysis with improved race identification indicated that AI/AN populations experienced higher heart disease death rates than Whites. Better prevention and more effective care of heart disease is needed for AI/AN populations.

Association of American Indian cultural identity with physical activity.

OBJECTIVE: Cultural factors are associated with health behaviors among American Indians. Accordingly, the objective of our study was to investigate whether cultural identity, defined as the primary language spoken at home, is associated with: 1) higher total physical activity levels, and 2) levels of leisure-time physical activity recommended for health benefits in a diverse sample of American Indians. DESIGN: Cross-sectional analysis of 5,207 American Indian adults 18 to 82 years. Participants resided on the Oglala Sioux (n=2,025) and Cheyenne River Sioux (n=1,528) reservations in South Dakota, and the Gila River Indian Community (n=1,654) in Arizona. RESULTS: Bicultural participants in South Dakota, but not Arizona, reported significantly higher total physical activity compared to the English-only group (P<.05). About 35% of English only speakers, 39% of American Indian/Alaska Native only speakers, and 39% of participants speaking both languages met the 150 minutes/week activity threshold. Odds of being sufficiently active were higher among bicultural respondents in both regions when compared to respondents endorsing only English, controlling for sociodemographic and health-related covariates (P<.05). CONCLUSION: Bicultural respondents among tribal members in South Dakota had significantly higher total physical activity, and higher levels of sufficient leisure-time activity in both South Dakota and Arizona, compared to those who spoke either language exclusively. Interventions that encourage American Indians to develop their bicultural efficacy and to draw on resources for healthy living that may be available in all the cultures with which they identify are recommended.

Religio-Spiritual Participation in Two American Indian Populations.

Following a previous investigation of religio-spiritual beliefs in American Indians, this article examined prevalence and correlates of religio-spiritual participation in two tribes in the Southwest and Northern Plains (N = 3,084). Analysis suggested a "religious profile" characterized by strong participation across three traditions: aboriginal, Christian, and Native American Church. However, sociodemographic variables that have reliably predicted participation in the general American population, notably gender and age, frequently failed to achieve significance in multivariate analyses for each tradition. Religio-spiritual participation was strongly and significantly related to belief salience for all traditions. Findings suggest that correlates of religious participation may be unique among American Indians, consistent with their distinctive religious profile. Results promise to inform researchers' efforts to understand and theorize about religio-spiritual behavior. They also provide tribal communities with practical information that might assist them in harnessing social networks to confront collective challenges through community-based participatory research collaborations.

Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study.

Background: In a parallel-group, international, phase 3 study (ClinicalTrials.govNCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03). Methods: Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18-55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control group, n = 479) received two primary doses, 21 days apart, of MV(D614). Anti-D614G and anti-B.1.351 antibodies were evaluated using validated pseudovirus (lentivirus) neutralization (PsVN) assay 14 days post-booster (day [D]15) in 18-55-year-old BNT162b2-primed participants and compared with those pre-booster (D1) and on D36 in 18-55-year-old controls (primary immunogenicity endpoints). PsVN titers to Omicron BA.1, BA.2 and BA.4/5 subvariants were also evaluated. Safety was evaluated over a 12-month follow-up period. Planned interim analyses are presented up to 14 days post-last vaccination for immunogenicity and over a median duration of 5 months for safety. Findings: All three boosters elicited robust anti-D614G or -B.1.351 PsVN responses for mRNA, adenovirus-vectored and protein vaccine-primed groups. Among BNT162b2-primed adults (18-55 years), geometric means of the individual post-booster versus pre-booster titer ratio (95% confidence interval [CI]) were: for MV (D614), 23.37 (18.58-29.38) (anti-D614G); for MV(B.1.351), 35.41 (26.71-46.95) (anti-B.1.351); and for BiV, 14.39 (11.39-18.28) (anti-D614G) and 34.18 (25.84-45.22 (anti-B.1.351). GMT ratios (98.3% CI) versus post-primary vaccination GMTs in controls, were: for MV(D614) booster, 2.16 (1.69; 2.75) [anti-D614G]; for MV(B.1.351), 1.96 (1.54; 2.50) [anti-B.1.351]; and for BiV, 2.34 (1.84; 2.96) [anti-D614G] and 1.39 (1.09; 1.77) [anti-B.1.351]. All booster formulations elicited cross-neutralizing antibodies against Omicron BA.2 (across priming vaccine subgroups), Omicron BA.1 (BNT162b2-primed participants) and Omicron BA.4/5 (BNT162b2-primed participants and MV D614-primed participants). Similar patterns in antibody responses were observed for participants aged ≥56 years. Reactogenicity tended to be transient and mild-to-moderate severity in all booster groups. No safety concerns were identified. Interpretation: CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of priming vaccine. Funding: Sanofi and Biomedical Advanced Research and Development Authority (BARDA).

Design of a randomized controlled trial of a web-based intervention to reduce cardiovascular disease risk factors among remote reservation-dwelling American Indian adults with type 2 diabetes.

We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings.

Community-responsive interventions to reduce cardiovascular risk in American Indians.

American Indian and Alaska Native (AI/AN) populations bear a heavy burden of cardiovascular disease (CVD), and they have the highest rates of risk factors for CVD, such as cigarette smoking, obesity, and diabetes, of any U.S. population group. Yet, few randomized controlled trials have been launched to test potential preventive interventions in Indian Country. Five randomized controlled trials were initiated recently in AI/AN communities to test the effectiveness of interventions targeting adults and/or children to promote healthy behaviors that are known to impact biological CVD risk factors. This article provides a context for and an overview of these five trials. The high burden of CVD among AI/AN populations will worsen unless behaviors and lifestyles affecting CVD risk can be modified. These five trials, if successful, represent a starting point in addressing these significant health disparities.

A Framework for Promoting Diversity, Equity, and Inclusion in Genetics and Genomics Research.

IMPORTANCE: Research into the genetic and genomic ("genomics") foundations of disease is central to our understanding of disease prevention, early detection, diagnostic accuracy, and therapeutic intervention. Inequitable participation in genomics research by historically excluded populations limits the ability to translate genomic knowledge to achieve health equity and ensure that findings are generalizable to diverse populations. OBSERVATIONS: We propose a novel framework for promoting diversity, equity, and inclusion in genomics research. Building on principles of community-based participatory research and collective impact frameworks, the framework can guide our understanding of the social, cultural, health system, policy, community, and individual contexts in which engagement and genomics research are being done. Our framework highlights the involvement of a multistakeholder team, including the participants and communities to be engaged, to ensure robust methods for recruitment, retention, return of genomic results, quality of engagement, follow-up, and monitoring of participants. CONCLUSIONS AND RELEVANCE: The proposed engagement framework will guide investigators in optimizing equitable representation in research and enhancing the rigor of genomics investigation.

Impact of hysterectomy and bilateral oophorectomy prevalence on rates of cervical, uterine, and ovarian cancer among American Indian and Alaska Native women, 1999-2004.

OBJECTIVE: To present more accurate incidence rates of cervical, uterine, and ovarian cancer by geographic region in American Indian/Alaska Native (AI/AN) women. METHODS: The authors used data from central cancer registries linked to Indian Health Service (IHS) patient registration database, the Behavioral Risk Factor Surveillance System, IHS National Data Warehouse, and the National Hospital Discharge Survey. Cancer incidence rates were adjusted for hysterectomy and oophorectomy prevalence and presented by region for non-Hispanic White (NHW) and AI/AN women. RESULTS: AI/AN women had a higher prevalence of hysterectomy (23.1%) compared with NHW women (20.9%). Correcting cancer rates for population-at-risk significantly increased the cancer incidence rates among AI/AN women: 43% for cervical cancer, 67% for uterine cancer, and 37% for ovarian cancer. Risk-correction led to increased differences in cervical cancer incidence between AI/AN and NHW women in certain regions. CONCLUSIONS: Current reporting of cervical, uterine, and ovarian cancer underestimates the incidence in women at risk and can affect the measure of cancer disparities. Improved cancer surveillance using methodology to correct for population-at-risk may better inform disease control priorities for AI/AN populations.

Soda intake and osteoporosis risk in postmenopausal American-Indian women.

OBJECTIVE: Low bone mass often leads to osteoporosis and increased risk of bone fractures. Soda consumption may contribute to imbalances that lead to decreased bone mineral density (BMD) and general bone health. We examined the relationship between soda consumption and osteoporosis risk in postmenopausal American-Indian women, an at-risk population because of nutritional and other lifestyle-related factors. DESIGN: Cross-sectional analysis using logistic regression to examine associations between soda consumption and osteoporosis, and linear regression to examine the association between soda consumption and BMD, with and without adjustment for demographic and lifestyle factors. Quantitative ultrasound of the heel was performed to estimate BMD (g/cm2). SETTING: American-Indian communities in the Northern Plains and Southwestern USA. SUBJECTS: A total of 438 postmenopausal American-Indian women. RESULTS: Women with osteoporosis were significantly older and had lower BMI, average daily soda intakes, BMD levels and use of hormones than women without osteoporosis (P < 0·05). Soda consumption was not associated with increased odds of osteoporosis in either unadjusted or adjusted models (P > 0·05), although age (increased), BMI (decreased) and past hormone use (decreased) were all significantly associated with osteoporosis risk (P < 0·05). CONCLUSIONS: Although the present study did not find associations between soda consumption and osteoporosis risk in postmenopausal American-Indian women, analyses did confirm confounding between soda consumption and age and BMI. This suggests that any potential effects of soda consumption on bone health are largely mediated through these factors.