Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study.

INTRODUCTION: In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice. METHODS AND ANALYSIS: A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis. ETHICS AND DISSEMINATION: This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study's CABs. A lay summary will also be disseminated to all participants.

Evaluating Human Papillomavirus eHealth in Hmong Adolescents to Promote Vaccinations: Pilot Feasibility Study.

BACKGROUND: Human papillomavirus (HPV) is a common sexually transmitted infection, causing multiple cancers, including cervical, penile, and anal. Infection and subsequent health risks caused by HPV can be diminished by HPV vaccination. Unfortunately, vaccination rates among Hmong Americans are substantially lower than those among other racial and ethnic groups, despite having higher cervical cancer rates than non-Hispanic White women. Such disparities and sparse literature highlight the need for innovative and culturally appropriate educational interventions to improve HPV vaccine rates in Hmong Americans. OBJECTIVE: We aimed to develop and evaluate the effectiveness and usability of an innovative web-based eHealth educational website, the Hmong Promoting Vaccines website (HmongHPV website), for Hmong-American parents and adolescents to improve their knowledge, self-efficacy, and decision-making capacities to obtain HPV vaccinations. METHODS: Through social cognitive theory and community-based participatory action research process, we created a theory-driven and culturally and linguistically appropriate website for Hmong parents and adolescents. We conducted a pre-post intervention pilot study to assess the website's effectiveness and usability. Overall, 30 Hmong-American parent and adolescent dyads responded to questions about HPV and HPV vaccine knowledge, self-efficacy, and decision-making at preintervention, 1 week after intervention, and at the 5-week follow-up. Participants responded to survey questions about website content and processes at 1 and 5 weeks, and a subset of 20 dyad participants participated in telephone interviews 6 weeks later. We used paired t tests (2-tailed) to measure the change in knowledge, self-efficacy, and decision-making processes, and used template analysis to identify a priori themes for website usability. RESULTS: Participants' HPV and HPV vaccine knowledge improved significantly from pre- to postintervention stage and follow-up. Knowledge scores increased from preintervention to 1 week after intervention for both parents (HPV knowledge, P=.01; vaccine knowledge, P=.01) and children (HPV knowledge, P=.01; vaccine knowledge, P<.001), which were sustained at the 5-week follow-up. Parents' average self-efficacy score increased from 21.6 at baseline to 23.9 (P=.007) at post intervention and 23.5 (P=.054) at follow-up. Similar improvements were observed in the teenagers' self-efficacy scores (from 30.3 at baseline to 35.6, P=.009, at post intervention and 35.9, P=.006, at follow-up). Collaborative decision-making between parents and adolescents improved immediately after using the website (P=.002) and at follow-up (P=.02). The interview data also revealed that the website's content was informative and engaging; in particular, participants enjoyed the web-based quizzes and vaccine reminders. CONCLUSIONS: This theory-driven, community-based participatory action research-designed and culturally and linguistically appropriate educational website was well received. It improved Hmong parents' and adolescents' knowledge, self-efficacy, and decision-making processes regarding HPV vaccination. Future studies should examine the website's impact on HPV vaccine uptake and its potential for broader use across various settings (eg, clinics and schools).

Population pharmacokinetics, pharmacodynamics and pharmacogenetics modelling of oxypurinol in Hmong adults with gout and/or hyperuricemia.

AIMS: The aim of this study was to quantify identifiable sources of variability, including key pharmacogenetic variants in oxypurinol pharmacokinetics and their pharmacodynamic effect on serum urate (SU). METHODS: Hmong participants (n = 34) received 100 mg allopurinol twice daily for 7 days followed by 150 mg allopurinol twice daily for 7 days. A sequential population pharmacokinetic pharmacodynamics (PKPD) analysis with non-linear mixed effects modelling was performed. Allopurinol maintenance dose to achieve target SU was simulated based on the final PKPD model. RESULTS: A one-compartment model with first-order absorption and elimination best described the oxypurinol concentration-time data. Inhibition of SU by oxypurinol was described with a direct inhibitory Emax model using steady-state oxypurinol concentrations. Fat-free body mass, estimated creatinine clearance and SLC22A12 rs505802 genotype (0.32 per T allele, 95% CI 0.13, 0.55) were found to predict differences in oxypurinol clearance. Oxypurinol concentration required to inhibit 50% of xanthine dehydrogenase activity was affected by PDZK1 rs12129861 genotype (-0.27 per A allele, 95% CI -0.38, -0.13). Most individuals with both PDZK1 rs12129861 AA and SLC22A12 rs505802 CC genotypes achieve target SU (with at least 75% success rate) with allopurinol below the maximum dose, regardless of renal function and body mass. In contrast, individuals with both PDZK1 rs12129861 GG and SLC22A12 rs505802 TT genotypes would require more than the maximum dose, thus requiring selection of alternative medications. CONCLUSIONS: The proposed allopurinol dosing guide uses individuals' fat-free mass, renal function and SLC22A12 rs505802 and PDZK1 rs12129861 genotypes to achieve target SU.

"We will do whatever it takes": Understanding Socioecological Level Influences on Hmong-American Adolescents and Parents' Perceptions of the Human Papillomavirus Vaccine.

Human papillomavirus (HPV) vaccination completion rates in Asian-American populations are substantially lower than most White Americans. Our objective was to identify the knowledge, perceptions, and decision-making processes about HPV vaccinations in the Hmong population, an Asian-American group with increased risks of HPV-related cancers. We conducted eight focus groups with Hmong adolescents (n = 12) and parents (n = 13) to learn about barriers, facilitators, and decision-making processes regarding general vaccinations and the HPV vaccine. The focus group results were analyzed using thematic analysis, informed by the socioecological model and asset lens. Findings showed that at the individual level, Hmong adolescents and parents had low HPV and HPV vaccine awareness levels (barrier) and strong desires to learn about HPV and the HPV vaccine (facilitator). Community-level barriers included salient narratives about traumatic experiences with vaccines and vaccine research, while facilitators included strong community connections. At the institutional level, barriers included structural constraints in health care settings, while facilitators included ease of obtaining vaccines at school-based clinics and provider authoritative decision-making. Additionally, a range of decision-making processes between parents, adolescents, and providers were present, with parents expressing a strong appeal to engage in more shared decision-making with providers. A linguistically and culturally specific HPV educational program for Hmong adolescents and parents could address the barriers and build on facilitators and assets to promote HPV vaccine uptake in this growing Asian-American community.

HLA-B*58: 01 carrier status of Hmong in Minnesota: first in Hmong genotyping for prevalence of this biomarker of risk for severe cutaneous adverse reactions caused by allopurinol.

Allopurinol, a common medication to treat gout, is associated with severe cutaneous adverse reactions, and the occurrence is highly predicted by an individual's HLA-B*58:01 carrier status. Guidelines endorse preemptive testing in select Asian populations before initiating allopurinol. The Hmong, an Asian subpopulation originally from China who now live dispersed around the world, have a 2.5-fold higher risk of gout when compared to non-Hmong in Minnesota. Given the concern for severe cutaneous adverse reactions when prescribing allopurinol, we quantified the carrier status of HLA-B*58:01 in Hmong from two independent cohorts in Minnesota. Using a community-based participatory research approach, HLA-B*58:01 carrier status was determined in 49 US-born Hmong without a history of gout or allopurinol use. Further, 47 Hmong patients undergoing clinical evaluation to receive gout pharmacotherapy were also tested. The frequency of HLA-B*58:01 positive carrier status in these two cohorts were compared to published data from a Han Chinese (n = 2910) and a Korean cohort (n = 485) using a Fisher's exact test with a Bonferroni-corrected P-value <0.025 for significance. With one uninterpretable result, we identified two out of 95 people (2.1%) who carried HLA-B*58:01. This 2.1% incidence in these Hmong adults is notably lower than Han Chinese (19.6%, P < 0.0001) and Korean (12.2%, P = 0.0016) populations. Though commonly understood to be of Chinese descent, the lower prevalence within the Hmong underscores the risk of generalizing genotypic findings from Chinese to Asian subpopulations. We suggest no change to the current guidelines recommending which populations should be tested for HLA-B*58:01 before allopurinol use until further validation.

Examining unanswered questions about the home environment and childhood obesity disparities using an incremental, mixed-methods, longitudinal study design: The Family Matters study.

There are disparities in the prevalence of childhood obesity for children from low-income and minority households. Mixed-methods studies that examine home environments in an in-depth manner are needed to identify potential mechanisms driving childhood obesity disparities that have not been examined in prior research. The Family Matters study aims to identify risk and protective factors for childhood obesity in low-income and minority households through a two-phased incremental, mixed-methods, and longitudinal approach. Individual, dyadic (i.e., parent/child; siblings), and familial factors that are associated with, or moderate associations with childhood obesity will be examined. Phase I includes in-home observations of diverse families (n=150; 25 each of African American, American Indian, Hispanic/Latino, Hmong, Somali, and White families). In-home observations include: (1) an interactive observational family task; (2) ecological momentary assessment of parent stress, mood, and parenting practices; (3) child and parent accelerometry; (4) three 24-hour child dietary recalls; (5) home food inventory; (6) built environment audit; (7) anthropometry on all family members; (8) an online survey; and (9) a parent interview. Phase I data will be used for analyses and to inform development of a culturally appropriate survey for Phase II. The survey will be administered at two time points to diverse parents (n=1200) of children ages 5-9. The main aim of the current paper is to describe the Family Matters complex study design and protocol and to report Phase I feasibility data for participant recruitment and study completion. Results from this comprehensive study will inform the development of culturally-tailored interventions to reduce childhood obesity disparities.

Gout in the Hmong in the United States.

OBJECTIVE: To compare characteristics of gout in Hmong patients versus whites, and examine if Hmong ethnicity is associated with risk of tophaceous gout. METHODS: A retrospective chart review of Hmong and White patients with gout in a large health care system (Health Partners) in St. Paul, Minnesota, from January 2001 to March 2008, to compare clinical characteristics and risk factors for gout. Multivariable-adjusted hierarchical logistic regressions examined the association of Hmong ethnicity with risk of tophaceous gout, adjusting for age, sex, hypertension, diuretic use, and kidney function. RESULTS: The analytic dataset consisted of 89 Hmong patients and 84 White controls, all of whom had ethnicity confirmed, an International Classification of Diseases, ninth revision code for gout and had at least 2 physician-documented diagnoses of gout. The Hmong group was younger (58.3 vs. 66.3 years, P = 0.04), had an earlier onset of symptoms (37.4 vs. 55.0 years, P < 0.001) and higher mean serum uric acid levels during follow-up (9.1 vs. 7.6 mg/dL, P < or = 0.001). Hmong had higher rates of tophaceous gout (31.5% vs. 10.7%, P = 0.001), including hand tophi (21.3% vs. 3.6%, P < 0.001). In multivariable analyses that adjusted for age, sex, hypertension, diuretic, use, and kidney function, Hmong ethnicity was significantly associated with risk of tophaceous gout, with odds ratio 4.3 (95% confidence interval: 1.5, 12.2). CONCLUSION: Hmong patients have an earlier onset of gout symptoms. Hmong race is an independent risk factor for tophaceous gout. Future studies need to examine whether genetic or other comorbid factors predict this higher risk of more severe gout in Hmong.

Cultural feeding practices and child-raising philosophy contribute to iron-deficiency anemia in refugee Hmong children.

OBJECTIVE: Iron-deficiency anemia is high in refugee Hmong toddlers attending Special Supplemental Food Program for Women, Infants, and Children (WIC) sites in St. Paul, Minnesota. We investigated social and cultural reasons for feeding practices of Hmong parents that result in excessive milk and inadequate food intake among infants and toddlers contributing to iron-deficiency anemia. DESIGN: In-depth interviews with community members. Focus-group interviews with caregivers. Discussions of results with a professional healthcare group. SETTING: St. Paul, Minnesota in 1997-1998. PARTICIPANTS: Eight Hmong and 7 non-Hmong community members. Thirty-two Hmong parents in focus groups. Thirteen Hmong and 11 non-Hmong healthcare professionals. MAIN OUTCOME MEASURES: Qualitative analysis identified themes from community and focus-group interviews. Professional group discussed meaning of results. RESULTS: To successfully adjust to American lifestyle demands, Hmong refugee families bottle-feed, rather than breast-feed, their infants. In the traditional demand pattern, bottle-feeding can cause infants to be given too much milk at the expense of solid food, and can teach them to prefer milk to food. As these infants become toddlers, caregivers have difficulty weaning them due to a child-raising philosophy of "hlu" that caters to children's desires. CONCLUSION: Hmong caregivers' child-raising philosophy of "hlu" coupled with feeding practices chosen to adjust to American society contribute to the high rate of iron-deficiency anemia in Hmong toddlers.