Inclusion of special populations in clinical research: important considerations and guidelines.

BACKGROUND: Trials that involve human participants call for experiments or observations that are performed in a clinical research setting. Currently, there are over 16,000 clinical trials open in the United States. Despite continuing efforts to include "special populations" in clinical trials, there are gaps in participation for people who are either minors or elderly adults, are from historically under-represented minorities, or live in rural communities. The inclusion of these special populations in clinical trials research is essential for conclusions that benefit all populations. Data suggest that study partic-ipation rates for special populations have fallen to levels that could endanger the successful performance of some types of research. This is particularly concerning in the 21st century, where demographic trends in the United States continue to shift towards an older and Hispanic population with fewer rural dwellers. Trends in New Mexico and other minority-majority states mirror many of these shifts. RELEVANCE FOR PATIENTS: In this review, we highlight improvement strategies for enhanced clinical trial participation by members of special populations. Key drivers for disparate clinical trials participation and outcomes often include differences in genetics, physiology, and perceptions of mistrust towards researchers. To overcome these barriers, we focus on best practices in recruitment strategies from the perspectives of the participants, the researchers and the institutions that support clinical trials.

Buffering the Uneven Impact of the Affordable Care Act: Immigrant-serving Safety-net Providers in New Mexico.

We conducted a study in early 2014 to document how the initial implementation of the Affordable Care Act (ACA) affected health care provision to different categories of immigrants from the perspective of health care providers in New Mexico. Though ACA navigators led enrollment, a range of providers nevertheless became involved by necessity, expressing concern about how immigrants were faring in the newly configured health care environment and taking on advocacy roles. Providers described interpreting shifting eligibility and coverage, attending to vulnerable under/uninsured patients, and negotiating new bureaucratic barriers for insured patients. Findings suggest that, like past efforts, this recent reform to the fragmented health care system has perpetuated a condition in which safety-net clinics and providers are left to buffer a widening gap for immigrant patients. With possible changes to the ACA ahead, safety-net providers' critical buffering roles will likely become more crucial, underscoring the necessity of examining their experiences with past reforms.

Effective Strategies for Affordable Care Act Enrollment in Immigrant-Serving Safety Net Clinics in New Mexico.

In the new Affordable Care Act (ACA) health care environment, safety-net institutions continue to serve as important sources of culturally appropriate care for different groups of immigrant patients. This article reports on a qualitative study examining the early ACA enrollment experiences of a range of health care providers (n = 29) in six immigrant-serving safety-net clinics in New Mexico. The six clinics configured their ACA enrollment strategies differently with regard to operations, staffing, and outreach. Providers reported a generally chaotic rollout overall and expressed frustration with strategies that did not accommodate patients, provided little training for providers, and engaged in minimal outreach. Conversely, providers lauded strategies that flexibly met patient needs, leveraged trust through strategic use of staff, and prioritized outreach. Findings underscore the importance of using and funding concerted strategies for future enrollment of immigrant patients, such as featuring community health workers and leveraging trust for outreach.

Viewing Focus Groups Through a Critical Incident Lens.

Scholars often do not describe in detail the complex process of conducting focus groups, including what happens when they take unexpected turns. A critical incident lens provides a framework for better analyzing and understanding what actually happens during focus group sessions. Using a critical incident approach, we examine our experiences of carrying out focus groups about the human papillomavirus (HPV) vaccine with vaccine-eligible adolescent girls and parents/caregivers of vaccine-eligible adolescent girls in New Mexico. The critical incident lens allowed us to productively explore the context and interactional dynamics of our focus groups and ultimately pushed us to talk through the challenges of conducting and analyzing them. We hope this serves as a call to qualitative researchers to be attentive to the critical incidents in your own research to enrich your analysis and contribute to a broader discussion of the realities of focus group conduct.

Catching Up With the HPV Vaccine: Challenges and Opportunities in Primary Care.

PURPOSE: Data confirm that high rates of human papillomavirus (HPV) vaccination have not been achieved despite strong clinician endorsement of the vaccine. We conducted a study of primary care clinicians to assess the broad range of health care delivery, health policy, and attitudinal factors influencing vaccination uptake and opportunities for informed decision making. METHODS: We implemented a mixed methods study in RIOS Net, a primary care practice-based research network in New Mexico. We first conducted qualitative, in-depth interviews with primary care clinicians, health policy makers, and immunization experts, and followed up with a confirmatory survey distributed to RIOS Net clinician members. RESULTS: Health service delivery challenges emerged as the greatest barrier to HPV vaccination, specifically the lack of capacity to track and distribute reminders to eligible patients. Clinicians also reported variations in counseling approaches attributable to both age and emphasis on the cancer prevention benefits of the vaccine. There was no evidence of sociocultural influences on vaccine decision making, nor did concerns about perceived overprotection emerge. CONCLUSIONS: Our findings, based on a long-term program of research, suggest that both patients' attributes and health system delivery are most influential in HPV vaccination coverage challenges. Interventions targeting innovative communication techniques, as well as health system changes that build on efforts toward coordinated care and utilization of other venues to promote vaccination, will be necessary to address these challenges.

Expressions of machismo in colorectal cancer screening among New Mexico Hispanic subpopulations.

Although national colorectal cancer (CRC) incidence rates have steadily decreased, the rate for New Mexico Hispanics has been increasing, and screening rates are low. We conducted an exploratory qualitative study to determine barriers to CRC screening for New Mexico Hispanics. We found that machismo served as a dynamic influence on men's health-seeking behaviors; however, it was conceptualized differently by two distinct Hispanic subpopulations, and therefore appeared to play a different role in shaping their screening attitudes and behaviors. Machismo emerged as more of an influence for Mexican men, who expressed concern over colonoscopies being potentially transformative and/or stigmatizing, but was not as salient for Hispanos, who viewed the colonoscopy as "strictly medical," and were more concerned with discomfort and pain. Findings from the study highlight the importance of identifying varying characteristics among subpopulations to better understand screening barriers and provide optimal CRC screening counseling in primary care settings.