Background: Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions.Methods: We used an informal consensus-based process informed by key methodological resources and our team’s complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research.Results: We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data.Conclusions: By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials.

The Indian Health Service (IHS) has made huge strides in narrowing health disparities between American Indian and Alaska Native (AI/AN) populations and other racial and ethnic groups. Yet, health disparities experienced by AI/AN people persist, with deep historical roots combined with present-day challenges. Here we review the history of the IHS from colonization to the present-day system, highlight persistent disparities in AI/AN health and health care, and discuss six key present-day challenges: inadequate funding, limited human resources, challenges associated with transitioning services from federal to Tribal control through contracting and compacting, evolving federal and state programs, the need for culturally sensitive services, and the promise and challenges of health technology.

Objective: To examine the association between baseline renal insufficiency and mortality among adults initiating antiretroviral therapy (ART) in an urban African setting. Design: Open cohort evaluation. Methods: We examined mortality according to baseline renal function among adults initiating ART in Lusaka, Zambia. Renal function was assessed by the Cockcroft–Gault method, the Modification of Diet in Renal Disease equation, and serum creatinine. Results: From April 2004 to September 2007, 25 779 individuals started ART with an available creatinine measurement at baseline. When creatinine clearance was calculated by the Cockcroft–Gault method, 8456 (33.5%) had renal insufficiency: 73.5% were mild (60–89 ml/min), 23.4% moderate (30–59 ml/min), and 3.1% severe (<30 ml/min). Risk for mortality at or before 90 days was elevated for those with mildly [adjusted hazard ratio (AHR) = 1.7; 95% confidence interval (95% CI) = 1.5–1.9], moderately (AHR = 2.3; 95% CI = 2.0–2.7), and severely (AHR = 4.3; 95% CI = 3.1–5.5) reduced creatinine clearance. Mild (AHR = 1.4; 95% CI = 1.2–1.6), moderate (AHR = 1.9; 95% CI = 1.5–2.3), and severe (AHR = 3.6; 95% CI = 2.4–5.5) insufficiency were also associated with increased mortality after 90 days, when compared with those with normal renal function. Trends were similar when renal function was estimated with Modification of Diet in Renal Disease or serum creatinine. Conclusion: Renal insufficiency at time of ART initiation was prevalent and associated with increased mortality risk among adults in this population. These results have particular relevance for settings like Zambia, where tenofovir – a drug with known nephrotoxicity – has been adopted as part of first-line therapy. This emphasizes the need for resource-appropriate screening algorithms for renal disease, both as part of ART eligibility and pretreatment assessment.

Background: Well-documented shortages of health care workers in sub-Saharan Africa are exacerbated by the increased human resource demands of rapidly expanding HIV care and treatment programmes. The successful continuation of existing programmes is threatened by health care worker burnout and HIV-related illness. Methods: From March to June 2007, we studied occupational burnout and utilization of HIV services among health providers in the Lusaka public health sector. Providers from 13 public clinics were given a 36-item, self-administered questionnaire and invited for focus group discussions and key-informant interviews. Results: Some 483 active clinical staff completed the questionnaire (84% response rate), 50 staff participated in six focus groups, and four individuals gave interviews. Focus group participants described burnout as feeling overworked, stressed and tired. In the survey, 51% reported occupational burnout. Risk factors were having another job (RR 1.4 95% CI 1.2–1.6) and knowing a co-worker who left in the last year (RR 1.6 95% CI 1.3–2.2). Reasons for co-worker attrition included: better pay (40%), feeling overworked or stressed (21%), moving away (16%), death (8%) and illness (5%). When asked about HIV testing, 370 of 456 (81%) reported having tested; 240 (50%) tested in the last year. In contrast, discussion groups perceived low testing rates. Both discussion groups and survey respondents identified confidentiality as the prime reason for not undergoing HIV testing. Conclusion: In Lusaka primary care clinics, overwork, illness and death were common reasons for attrition. Programmes to improve access, acceptability and confidentiality of health care services for clinical providers and to reduce workplace stress could substantially affect workforce stability.