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.
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.
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.
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.
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.
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.
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.
American Indians have the highest rates of smokeless tobacco (SLT) use of any racial/ethnic group in the United States, yet no proven effective cessation programs exist for them. Because tobacco is a ...sacred plant to many American Indians, cessation programs must not portray it in a completely negative manner. Based on our successful All Nations Breath of Life smoking cessation program, we developed and pilot-tested the All Nations Snuff Out Smokeless (ANSOS) program. Of 48 participants who began the program, 33 completed to six months (68.8% retention rate). Among participants who completed the program, 11 (34%) self-reported abstinence. When those lost to follow-up are considered current users, the cessation rate is 22.9%. An additional 14 individuals reported decreasing use (29.2% of all participants), with an average of 3.4 days per week decrease. All Nations Snuff Out Smokeless shows promise as a culturally appropriate SLT cessation program and is ready for efficacy testing.
A community-based participatory approach requires that community members be involved in all phases of the research process. We describe three focus group studies with American Indians in Kansas and ...Missouri, using a newly developed method of conducting and analyzing focus groups with community input (72 focus groups, 519 participants). We conducted two needs assessment studies focused on barriers to breast and colorectal cancer screening and one study focused on Internet use for gathering health information. Community members and researchers collaborated to develop guides for the focus group moderators. Community organizations and our community advisory board conducted recruitment, and we trained and employed community members as moderators, assistant moderators, and analysts. Our community partners also helped with dissemination of research findings to their constituents. The methodologic approach and data from these three studies will allow us to more appropriately address health disparities in the American Indian community, with full community support for our research.
The objective of this study was to learn more about the attitudes concerning pediatric obesity among rural parents, the barriers these parents face in trying to help their children attain a healthy ...weight status, and the pediatric weight loss services currently available in small rural communities. A series of eight qualitative focus groups were conducted with 21 parents of overweight rural children in third through fifth grade. Eight saturated themes resulted indicating that parents (i) believe overweight children are lazy, (ii) are concerned about the weight of their children, (iii) believe that some individuals will be overweight no matter what they do, and (iv) have tried a variety of techniques to help their children lose weight. Barriers to helping their children lose weight unique to their rural status included lack of weight loss resources in their community, lack of exercise facilities, and lack of low‐fat or low‐calorie options in grocery stores. Rural families of overweight children encounter many barriers to healthier living, some of which are unique to their rural status.
Abstract Background American Indian/Alaska Native (AI/AN) women have lower breast cancer (BCA) screening and 5-year survival rates than non-Hispanic Whites. Understanding reasons for low screening ...rates is important to combatting later stage diagnoses. The purpose of this study was to assess mammography experiences and satisfaction among AI/AN women. Methods Nine focus groups were held with rural (N = 15) and urban (N = 38) AI/AN women 40 years and older in Kansas and Kansas City, Missouri, living both near and far from Indian Health Service (IHS) and tribal facilities, to examine experiences and satisfaction with mammography. Transcripts were coded and themes identified using a community-based participatory research approach. Findings Themes were classified under knowledge, communication, and awareness of BCA; barriers to mammography; mammogram facility size; impressions of mammogram technologist; motivations for getting a mammogram; and how to improve the mammogram experience. Participants had knowledge of prevention, but described cultural reasons for not discussing it and described better experiences in smaller facilities. Participants indicated having a mammogram technologist who was friendly, knowledgeable, respectful, competent, and explained the test was a determining factor in satisfaction. Other factors included family history, physician recommendation, and financial incentives. Barriers included transportation, cost, perceptions of prejudice, and time constraints. Participants on reservations or near IHS facilities preferred IHS over mainstream providers. Suggestions for improvement included caring technologists, better machines with less discomfort, and education. Conclusions Interventions to enhance the professionalism, empathy, and cultural awareness of mammogram technologists; reduce barriers; and provide positive expectations and incentives could improve satisfaction and compliance with screening mammography.
Abstract only
e18037
Background: Clinical trial enrollment at a group of community oncology sites dropped significantly surrounding acquisition by an academic medical center. While previous research ...used empirical data to identify enrollment barriers, this study used a theoretical framework to investigate research site personnel behavior associated with enrollment, and to further explore clinical trial enrollment barriers. Methods: Data from focus groups and interviews were analyzed using the integrated TDF and COM-B theoretical framework 1 . 1 Theoretical Domains Framework with Capability, Opportunity, Motivation Behavior Wheel. Results: Fifty-six community personnel 2 participated in focus groups and interviews about enrollment experiences before and after the acquisition. Participants described how changes in the workplace and resources affected their Opportunity to enroll: "It's kind of hard to put somebody on a study when you don't have one available." -cs "You can't grow a research department by cutting staff. What message does it send to the organization as far as the importance of research? …it makes you wonder whether the organization truly backs the research effort." -m Physician participants specifically shared that the lack of time and staff devoted to research hampered enrollment efforts, consequently affecting their Motivation: “Current road block is that doc doesn't have time to go through the patient records, so if the study coordinator could determine eligibility before the patient visit, that would be helpful.” -p Participants expressed frustration in not knowing the processes for opening trials, therefore their Capability was affected. “I think in the past, we knew more about what was out there, where I don't see as much of that here now. I don't know if it's because we don't have a research nurse or we are not getting a list of trials anymore or what is going on." -cs 2 Quotes from personnel cs = clinic staff, m = manager, p = provider. Conclusions: Participants perceived many barriers to clinical trial enrollment after the acquisition. To optimally continue providing services as expected, support systems need to be maintained. This study provided evidence of using the TDF for exploring enrollment barriers.
To examine knowledge, attitudes, beliefs, and behaviors about alternative tobacco products among American Indian tribal college students.
One hundred and five tribal college students.
Focus groups, ...one interview, and demographic surveys.
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.
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.
PDF
