Using Bayesian hierarchical models for controlled post hoc subgroup analysis of clinical trials: application to smoking cessation treatment in American Indians and Alaska Natives.

Clinical trials powered to detect subgroup effects provide the most reliable data on heterogeneity of treatment effect among different subpopulations. However, pre-specified subgroup analysis is not always practical and post hoc analysis results should be examined cautiously. Bayesian hierarchical modelling provides grounds for defining a controlled post hoc analysis plan that is developed after seeing outcome data for the population but before unblinding the outcome by subgroup. Using simulation based on the results from a tobacco cessation clinical trial conducted among the general population, we defined an analysis plan to assess treatment effect among American Indians and Alaska Natives (AI/AN) enrolled in the study. Patients were randomized into two arms using Bayesian adaptive design. For the opt-in arm, clinicians offered a cessation treatment plan after verifying that a patient was ready to quit. For the opt-out arm, clinicians provided all participants with free cessation medications and referred them to a Quitline. The study was powered to test a hypothesis of significantly higher quit rates for the opt-out arm at one-month post randomization. Overall, one-month abstinence rates were 15.9% and 21.5% (opt-in and opt-out arm, respectively). For AI/AN, one-month abstinence rates were 10.2% and 22.0% (opt-in and opt-out arm, respectively). The posterior probability that the abstinence rate in the treatment arm is higher is 0.96, indicating that AI/AN demonstrate response to treatment at almost the same probability as the whole population.

A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial.

BACKGROUND: Despite numerous benefits for both mom and baby, few infants are exclusively breastfed for the recommended first six months. Additionally, infants are given solids too early. Prenatal education increases rates of breastfeeding initiation and we hypothesize it can also improve exclusive breastfeeding rates and prevent the early introduction of solids. We conducted a randomized controlled pilot and feasibility trial to understand the feasibility and maternal acceptance of a prenatal behavioral lifestyle intervention (PBLI) delivered via group based phone counseling (GBPC) and its effectiveness on rates of exclusive breastfeeding up to six months postpartum. Secondary aims included rates of any breastfeeding up to six months, rates of early introduction of solids, and infant feeding progression. METHODS: Forty-one pregnant women were recruited from a Kansas City Metropolitan Obstetrics and Gynecology office and randomly assigned to a usual care group or a PBLI. Women in the PBLI participated in six GBPC sessions where they learned about breastfeeding and introducing solids. Feeding questionnaires to assess breastfeeding and introduction of solids were sent at two weeks, two months, four months, and six months postpartum. Structured interviews were also conducted after the intervention and at six months postpartum to assess maternal acceptance and intervention feasibility. RESULTS: Participants overwhelmingly found the intervention acceptable and beneficial. Rates of exclusive breastfeeding and any breastfeeding did not differ between groups at any time point. No between group differences were found for early introduction of solids or infant feeding progression. CONCLUSIONS: Mothers discontinue breastfeeding earlier than recommended despite high rates of initiation. A PBLI delivered via GBP is feasible, acceptable to participants, and showed positive impacts such as maternal empowerment for both breastfeeding and introducing solids. Future interventions should incorporate both prenatal and postpartum components. TRIAL REGISTRATION: Study protocols were approved by the University of Kansas Medical Center's Human Subjects Committee (STUDY00140506) and registered at ClinicalTrials.gov on 02/22/2018 ( NCT03442517 , retrospectively registered). All participants gave written informed consent prior to data collection.

Baseline characteristics of American Indian smokeless tobacco users participating in two pilot cessation studies.

American Indians have higher rates of smokeless tobacco (SLT) use than other racial/ethnic groups in the US, yet no efficacious cessation program exists for them. Because tobacco is a sacred plant to many American Indians, it is imperative that a program respect the scared nature of tobacco while encouraging quitting recreational use. All Nations Snuff Out Smokeless (ANSOS) was designed to help American Indian SLT users quit recreational tobacco use while still using it for traditional purposes. We pilot tested the ANSOS 6-month group-based counseling program (N = 48) and a shortened version consisting of a one-time education session (N = 80). Here, we discuss the tobacco characteristics of participants at baseline in both studies. Participants across studies were more likely to be male (74.2%) and have at least a college education (65%). Participants in the one-time education sessions were younger (age 35 vs age 39) and used SLT fewer days per week (4.9 vs 5.7). Two-thirds of those in the full program reported that they often substitute SLT in locations where smoking is not allowed compared to 26%. Participants in the education sessions were more likely to report daily use of traditional tobacco (20% versus 0%). Results suggest that dual use of SLT and cigarettes needs to be addressed, as does the use of SLT to circumvent public smoking rules. The role of traditional tobacco and its relationship to lower SLT use also warrants further investigation.

One-Time Education Sessions to Help American Indian Smokeless Tobacco Users Quit.

American Indian (AI) smokeless tobacco use rates are the highest of all racial/ethnic groups within the United States. Despite this, no effective cessation program currently exists that acknowledges the cultural significance of tobacco among many American Indian tribal nations. Participants were smokeless tobacco users, over 18 years of age, and were recruited through community partners. We modified the All Nations Snuff Out Smokeless Tobacco group-based program to be delivered as a one-time education session intervention. This was delivered to 80 participants and follow-up data was collected by self-report at 6-months. The mean age of participants was 35 and most were male (70%). A majority (69%) grew up on a AI reservation; the mean age of first smokeless tobacco use was 16 years of age. Of program completers reached for 6-month post baseline, 46% reported 0 days of SLT use; 13.5% of participants reduced; while 36% reported continued daily use. In intention to treat analysis those lost to follow-up are considered current users, the quit rate was 12.5% and among those who were still using, 4.0% reduced their use. In this study, a one-time education session intervention was effective for those who prefer an individual based approach to quitting SLT use. Follow up strategies to increase participant retention at 6-months should be explored.

Feasibility of Implementing the All Nations Breath of Life Culturally Tailored Smoking Cessation Program for American Indians in Multi-Tribal Urban Communities.

Introduction: Prevalence of cigarette smoking is highest among American Indians, yet few culturally appropriate smoking cessation programs have yet been developed and tested for multi-tribal American Indian adult populations. This study examined implementation of the All Nations Breath of Life culturally tailored smoking cessation program in multi-tribal urban and suburban American Indian communities in seven locations across five states (N = 312). Methods: This single-arm study used community-based participatory research to conduct a 12-week intervention whose primary purpose was to curb commercial tobacco use among American Indians. Participants were followed through month 6 in person and month 12 via telephone. The primary outcome was continuous abstinence from recreational cigarette smoking at 6 months post-baseline, verified through voluntary provision of salivary cotinine levels. Results: At program completion (12 weeks post-baseline), 53.3% of program completers remained abstinent; labeling those lost to follow-up as smokers resulted in a 41.4% quit rate. At 6 months post-baseline (primary endpoint), 31.1% of retained participants quit smoking (p < .0001 compared to the highest quit rates among multi-tribal populations reported in the literature, 7%); final quit rate was 22.1% labeling those lost to follow-up as smokers (p = .002). Retention rate at endpoint was 71.2%. 12-month follow-up was attempted with all participants and had a retention rate of 49.0%. Of those participants reached, 34.0% were smoke-free. Conclusions: All Nations Breath of Life shows promise as a smoking cessation program for multi-tribal urban American Indian communities. It can be successfully implemented in a variety of urban settings. Implications: This is the first large feasibility study of a culturally tailored smoking cessation program for American Indians with good cessation and retention rates in a multi-tribal urban American Indian population. It shows that All Nations Breath of Life can be implemented in multiple urban settings across five states. To our knowledge, this is the first program of its kind to be implemented across multiple heterogeneous urban locations and to include salivary cotinine testing for verification of self-report data across these locations.

Food Security and Diet Among American Indians in the Midwest.

The purpose of this study was to determine levels of food security among American Indians (AI) living in the Midwest and possible correlations between food security levels and various health outcomes, diet, and demographic variables. This study used a cross-sectional design to determine health behaviors among AI. Participants (n = 362) were recruited by AI staff through various cultural community events in the Midwest, such as powwows and health fairs. Inclusion criteria included the following: age 18 years or older, self-identify as an AI, and willing to participate in the survey. Of all participants, 210 (58%) had either low or very low food security, with 96 in the very low category (26.5%). Participants with very low food security tended to have significantly more chronic conditions. Additional significant differences for very low food security existed by demographic variables, including having no insurance (p < 0.0001) or having a regular primary care provider (p = 0.0354). There was also a significant difference between food security levels and the consumption of fast food within the past week (p value = 0.0420), though no differences were found in fruit and vegetable consumption. AI in our sample had higher levels of food insecurity than those reported in the literature for other racial/ethnic groups. AI and non-Native health professionals should be aware of the gravity of food insecurity and the impact it has on overall health. Additional research is needed to determine specific aspects of food insecurity affecting different Native communities to develop appropriate interventions.

A novel evaluation of optimality for randomized controlled trials.

Balanced two-arm designs are more powerful than unbalanced designs and, consequently, Bayesian adaptive designs (BADs) are less powerful. However, when considering other subject- or community-focused design characteristics, fixed two-arm designs can be suboptimal. We use a novel approach to identify the best two-arm study design, taking into consideration both the statistical perspective and the community's perception. Data envelopment analysis (DEA) was used to estimate the relative performance of competing designs in the presence of multiple optimality criteria. The two-arm fixed design has enough deficiencies in subject- and community-specific benefit to make it the least favorable study design.

American Indian Knowledge, Attitudes, and Beliefs About Smokeless Tobacco: A Comparison of Two Focus Group Studies.

Though smokeless tobacco (SLT) use has decreased in many communities, concern for American Indian (AI) SLT use remains, as this population continues to be disproportionally affected by SLT-related diseases. Tobacco has cultural significance to many AI tribes, therefore tobacco cessation messages portraying tobacco as entirely negative may be ineffective. As a part of our formative research for an SLT cessation intervention, we sought to gain a better understanding of the knowledge, attitudes, and beliefs about SLT among AI community members. We describe two independent focus group studies conducted in Montana (ten focus groups, 54 participants) and Kansas (six focus groups, 27 participants). Predominant themes emerged from three major topic areas (SLT use, program development, and recreational SLT use) during the discussions from both studies. The formative approach and data from these studies will allow us to more appropriately address SLT-related health disparities across multiple AI communities.

Methodological Challenges in Conducting Research with Refugee Women.

The purpose of this pilot study was to evaluate the acceptability and feasibility of a 10-week community-based, culturally tailored mental health intervention, called Healthy Sudanese Families, with 12 South Sudanese refugee women living in a metropolitan area of the Midwestern United States. This mixed-methods study used the Dinka and Arabic versions of the Hopkins Symptoms Checklist-25 to measure indicators of anxiety and depression and a final focus group to evaluate the women's responses to the intervention. The women found the mental health intervention acceptable and relevant. Methodological challenges encountered in cross-cultural research with refugees are discussed.

Recruitment and Baseline Characteristics of American Indian Tribal College Students Participating in a Tribal College Tobacco and Behavioral Survey.

INTRODUCTION: American Indians (AIs) have the highest cigarette smoking rates of any racial/ethnic group in the United States. Although the overall smoking prevalence in the United States for nonminority populations has decreased over the past several decades, the same pattern is not observed among AIs. The purpose of this observational study was to collect cigarette smoking and related information from American Indian tribal college students to inform tailored interventions. METHODS: We conducted a repeated cross-sectional survey of American Indian tribal college students, Tribal College Tobacco and Behavior Survey (TCTABS), with a focus on recruiting all incoming freshman at three participating tribal colleges in the Midwest and Northern Plains regions. A total of 1256 students participated in the baseline surveys between April 2011 and October 2014. RESULTS: The overall smoking prevalence of this sample was 34.7%, with differences by region (Northern Plains-44.0% and Midwest-28%). The majority, 87.5% of current smokers reported smoking 10 or less cigarettes per day, 41% reported smoking menthol cigarettes, 52% smoked Marlboro brand, and the mean age of their first cigarette was 14 years. The majority, 62% had made at least one quit attempt in the past year. The overwhelming majority of respondents, regardless of their smoking status, thought that the current smoking prevalence on campus was greater than 41% and approximately one-third believed that it was as high as 61%. CONCLUSIONS: Very few studies of smoking have been conducted in this population and results from our study confirm the need for effective interventions. IMPLICATIONS: AIs have the highest cigarette smoking rates compared to other racial/ethnic groups in the United States. Furthermore, limited studies have examined the epidemiology of cigarette smoking among tribal college students. This study addresses health disparities related to smoking among college students by examining the demographic, cultural, and environmental characteristics of smoking and quitting. Results from this study could lead to the development of a culturally-tailored smoking cessation and prevention program for American Indian tribal college students.

COLORECTAL CANCER SCREENING PRACTICES AMONG THREE AMERICAN INDIAN COMMUNITIES IN MINNESOTA.

Colorectal cancer (CRC) is a leading cause of cancer morbidity and mortality. Effective prevention and early detection may be achieved through screening, but screening rates are low, especially in American Indian (AI) populations. We wanted to understand perceptions of CRC screening among AI located in the Great Lakes region. Focus groups were recorded and transcribed verbatim (N = 45). Data were analyzed using qualitative text analysis. Themes that deterred CRC screening were low CRC knowledge, fear of the procedure and results, cost and transportation issues, and a lack of quality and competent care. Suggestions for improvement included outreach efforts and culturally-tailored teaching materials.

Geographic variation in colorectal cancer incidence and mortality, age of onset, and stage at diagnosis among American Indian and Alaska Native people, 1990-2009.

OBJECTIVES: We characterized estimates of colorectal cancer (CRC) in American Indians/Alaska Natives (AI/ANs) compared with Whites using a linkage methodology to improve AI/AN classification in incidence and mortality data. METHODS: We linked incidence and mortality data to Indian Health Service enrollment records. Our analyses were restricted to Contract Health Services Delivery Area counties. We analyzed death and incidence rates of CRC for AI/AN persons and Whites by 6 regions from 1999 to 2009. Trends were described using linear modeling. RESULTS: The AI/AN colorectal cancer incidence was 21% higher and mortality 39% higher than in Whites. Although incidence and mortality significantly declined among Whites, AI/AN incidence did not change significantly, and mortality declined only in the Northern Plains. AI/AN persons had a higher incidence of CRC than Whites in all ages and were more often diagnosed with late stage CRC than Whites. CONCLUSIONS: Compared with Whites, AI/AN individuals in many regions had a higher burden of CRC and stable or increasing CRC mortality. An understanding of the factors driving these regional disparities could offer critical insights for prevention and control programs.

Homes of low-income minority families with asthmatic children have increased condition issues.

The home is increasingly associated with asthma. It acts both as a reservoir of asthma triggers and as a refuge from seasonal outdoor allergen exposure. Racial/ethnic minority families with low incomes tend to reside in neighborhoods with low housing quality. These families also have higher rates of asthma. This study explores the hypothesis that black and Latino urban households with asthmatic children experienced more home mechanical, structural condition-related areas of concern than white households with asthmatic children. Participant families (n = 140) took part in the Kansas City Safe and Healthy Homes Program, had at least one asthmatic child, and met income qualifications of no more than 80% of local median income; many were below 50%. Families self-identified their race. Homes were assessed by environmental health professionals using a standard set of criteria and a specific set of on-site and laboratory sampling and analyses. Homes were given a score for areas of concern between 0 (best) and 53 (worst). The study population self-identified as black (46%), non-Latino white (26%), Latino (14.3%), and other (12.9%). Mean number of areas of concern were 18.7 in Latino homes, 17.8 in black homes, 13.3 in other homes, and 13.2 in white homes. Latino and black homes had significantly more areas of concern. White families were also more likely to be in the upper portion of the income. In this set of 140 low-income homes with an asthmatic child, households of minority individuals had more areas of condition concerns and generally lower income than other families.

Understanding American Indian tribal college student knowledge, attitudes, beliefs, and behaviors surrounding alternative tobacco products.

OBJECTIVES: To examine knowledge, attitudes, beliefs, and behaviors about alternative tobacco products among American Indian tribal college students. PARTICIPANTS: One hundred and five tribal college students. METHODS: Focus groups, one interview, and demographic surveys. RESULTS: Tobacco use varied across the sample with 35.2% of the participants being users of ENDS products and 29.5% were cigarette smokers. Overall, participants viewed electronic nicotine delivery systems and chewing tobacco as primary examples of alternative tobacco products and described a generational divide between alternative and conventional tobacco product use. Alternative tobacco products were not considered suitable for use in traditional contexts. CONCLUSIONS: Previously successful cessation programs in this population have relied on cultural tailoring related to traditional tobacco use in American Indian communities. Our findings suggest that this strategy may be less effective for addressing alternative tobacco use. Reliance on the importance of family relationships may prove more impactful in future programming.

Moving forward: breaking the cycle of mistrust between American Indians and researchers.

American Indians (AIs) have some of the poorest documented health outcomes of any racial/ethnic group. Research plays a vital role in addressing these health disparities. Historical and recent instances of unethical research, specifically the Havasupai diabetes project, have generated mistrust in AI communities. To address the concerns about unethical research held by some AIs in the Heartland (Midwest), the Center for American Indian Community Health (CAICH) has launched a series of efforts to inform AIs about research participants' rights. CAICH educates health researchers about the importance of learning and respecting a community's history, culture, values, and wishes when engaging in research with that community. Through community-based participatory research, CAICH is also empowering AIs to assert their rights as research participants.

Perceptions, barriers, and suggestions for creation of a tobacco and health website among American Indian/Alaska Native college students.

Information concerning American Indian/Alaska Native (AI/AN) Internet use and health information needs is dearth. Our research team explored Internet use among AI/AN college students to determine Internet use in relation to health information seeking behaviors. We used a tobacco site example for participants to describe what they desired in a health site designed specifically for AI/AN. Using a community-based participatory research approach, we conducted 14 focus groups with AI/AN college students (N = 108), to better understand their perceptions of and attitudes toward Internet use and health information needs. Daily Internet use was reported across strata yet health topics investigated differed among groups. Participants in all strata desired a health website that was easy to navigate and interactive. Respectful representation of Native culture was a concern, yet no consensus was reached for a multi-tribal audience. Participants felt a website should use caution with cultural depictions due to the possible misinterpretation. Overall, participants agreed that recreational and traditional tobacco use should be differentiated and the variation of traditional use among tribes acknowledged. Data concerning Internet use for health information among AI/AN college students are needed to establish baseline indicators to effectively address disparities.

Employing the church as a marketer of cancer prevention: a look at a health promotion project aimed to reduce colorectal cancer among African Americans in the Midwest.

Health promotion programs designed to address colorectal cancer disparities among African Americans are increasing. Unfortunately, this group still shoulders a disproportionate mortality burden in the United States; these numbers are also reflective of colorectal cancer (CRC) disparities in the Midwest. The purpose of this study was to extrapolate results from in-depth interviews and brief surveys on the effectiveness of the church as a social marketer of CRC-prevention messages. Results show that pastors believe the congregation has limited knowledge about CRC risk and prevention; they also believe the church can improve cancer-prevention communication among members and those affiliated with the church.

Barriers to colorectal cancer screening among American Indian men aged 50 or older, Kansas and Missouri, 2006-2008.

American Indian (AI) men have some of the highest rates of colorectal cancer (CRC) in the United States but among the lowest screening rates. Our goal was to better understand awareness and discourse about colorectal cancer in a heterogeneous group of AI men in the Midwestern United States. Focus groups were conducted with AI men (N = 29); data were analyzed using a community-participatory approach to qualitative text analysis. Several themes were identified regarding knowledge, knowledge sources, and barriers to and facilitators of screening. Men in the study felt that awareness about colorectal cancer was low, and people were interested in learning more. Education strategies need to be culturally relevant and specific.

American Indian perceptions of colorectal cancer screening: viewpoints from adults under age 50.

Colorectal cancer (CRC) mortality rates have decreased in the general US population; however, CRC mortality rates are increasing among American Indians (AI). AI CRC screening rates remain low when compared to other ethnic groups. Our team investigated CRC screening education prior to recommended age for screening to better understand screening perceptions among AI community members. Our research team conducted 11 focus groups with AI men and women aged 30-49 (N = 39 men and N = 31 women) in Kansas and Missouri. The results revealed that community members (1) have little knowledge of CRC, (2) do not openly discuss CRC, and (3) want additional CRC education. Variations existed among men and women's groups, but they agreed that preventive measures need to be appropriate for AI communities. Thus, AI CRC screening interventions should be culturally tailored to better meet the needs of the population.

Breast cancer screening perceptions among American Indian women under age 40.

Breast cancer mortality rates are the second leading cause of cancer death in American Indian (AI) women. AI breast cancer screening rates have been decreasing, and AI women have some of the lowest screening rates compared to other racial/ethnic groups. Our research team investigated breast cancer and breast cancer screening education prior to recommended age for screening. It is imperative to examine the perspectives of young AI women toward breast cancer screening to better understand screening perceptions among AI women. Following a community-based participatory research approach, we conducted five focus groups and four interviews with AI women aged 25-39 (N = 48) in Kansas and Missouri. Nine themes emerged from the focus groups and relate to topics such as the following: knowledge of breast cancer and breast cancer screening, barriers to screening and treatment, suggestions to improve access, and perceptions and use of health-care systems. Specifically, we found that AI women lacked knowledge of details about screenings and their risks for getting breast cancer, cost was cited as a primary barrier to screening, additional education was needed (particularly materials that were AI focused), breast health was generally not discussed with others, and more instruction was requested for techniques used to identify bodily changes or abnormalities. Understanding attitudes of AI women not of recommended screening age may provide an insight into low screening rates among AI women. Furthermore, the results may inform outreach strategies to improve current and future screening rates.