Testing the validity and reliability of the Person-Centered Contraceptive Counseling (PCCC) Performance Measure in a Real-World Contraceptive Access Program.

OBJECTIVES: To validate the Person-Centered Contraceptive Counseling (PCCC) patient-reported outcome performance measure and assess for differences by sociodemographic attributes using survey data from a multistate contraceptive access program. STUDY DESIGN: This analysis explored internal reliability and construct validity of the PCCC using survey data from 1413 patients who visited 15 health centers in Washington state and Massachusetts that had partnered with Upstream USA. RESULTS: Multiple psychometric indicators provided evidence of reliability and validity. Significant associations between the highest PCCC rating and conceptually-related survey questions (i.e., experience with bias/coercion and shared decision-making) provided further evidence of construct validity. CONCLUSIONS: Our findings demonstrate that the PCCC is valid and reliable. The results also highlight differences in experience of care by patient-reported race and ethnicity, income level, and language.

Novel Ex Vivo Zymography Approach for Assessment of Protease Activity in Tissues with Activatable Antibodies.

Proteases are involved in the control of numerous physiological processes, and their dysregulation has been identified in a wide range of pathologies, including cancer. Protease activity is normally tightly regulated post-translationally and therefore cannot be accurately estimated based on mRNA or protein expression alone. While several types of zymography approaches to estimate protease activity exist, there remains a need for a robust and reliable technique to measure protease activity in biological tissues. We present a novel quantitative ex vivo zymography (QZ) technology based on Probody® therapeutics (Pb-Tx), a novel class of protease-activated cancer therapeutics that contain a substrate linker cleavable by tumor-associated proteases. This approach enables the measurement and comparison of protease activity in biological tissues via the detection of Pb-Tx activation. By exploiting substrate specificity and selectivity, cataloguing and differentiating protease activities is possible, with further refinement achieved using protease-specific inhibitors. Using the QZ assay and human tumor xenografts, patient tumor tissues, and patient plasma, we characterized protease activity in preclinical and clinical samples. The QZ assay offers the potential to increase our understanding of protease activity in tissues and inform diagnostic and therapeutic development for diseases, such as cancer, that are characterized by dysregulated proteolysis.

Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY = 97%, MFHP = 51%; p < .0001). Concordance between tool and genetic counselor was significantly greater for participants randomized to VICKY compared to MFHP for ascertaining first- and second-degree relatives (ps<.0001), and most health conditions examined. There was significant interaction by health literacy, with greater differences in concordance observed between tools among those with limited literacy. CONCLUSIONS: A virtual counselor overcomes many of the literacy-related barriers to using traditional digital tools and highlights an approach that may be important to consider when collecting health histories from vulnerable populations. PRACTICE IMPLICATIONS: The usability of digital health history tools will have important implications for the quality of the data collected and its downstream clinical utility.

Influence of Family and Community Socioeconomic Status on the Risk of Adolescent Drug Use.

Background: Adolescent drug use increases the risk of mental, physical and social problems later in life and so it is important to understand its complex etiology that likely includes socioeconomic status (SES). We undertook the present analysis using data from a population-based retrospective cohort study to examine the influence of family and community SES in relation to adolescent drug use. We hypothesized that lower levels of community and parental SES would increase the risk of use and that there would be stronger associations for the more proximate family-level factors. Methods: We used self-administered questionnaires (N=1,402) to obtain information on use of marijuana, inhalants, heroin, cocaine/crack, psychedelics/hallucinogens, Ritalin without a prescription, and club drugs during adolescence. Family SES was gathered from birth certificate data on maternal educational level and paternal occupation. Community SES characteristics at birth, age 10 and age 18 were obtained from the US Census Bureau. Results: An increased risk of adolescent drug use was associated with lower maternal education, non-white collar occupations among fathers, and lower community median income, and poverty and unemployment levels at age 18. The strongest associations were seen for the use of multiple drugs (Risk Ratio (RR): 1.7, 95% CI: 1.4-2.2), inhalants (RR: 2.5, 95% CI: 1.5-2.2), crack/cocaine (RR: 2.8, 95% CI: 1.7-4.5), psychedelics/hallucinogens (RR: 1.8, 95% CI: 1.4-2.4), and club/designer drugs (RR: 1.8, 95% CI: 1.2-2.7) among adolescents whose mothers had only a high school education. Conclusions: These results suggest that use of certain drugs during adolescence is associated with both family and community SES measures. However, maternal education appears to have the greatest influence on use, suggesting that a multi-level approach that engages mothers is needed to prevent adolescent drug use.

Designing and Evaluating a Digital Family Health History Tool for Spanish Speakers.

Digital family health history tools have been developed but few have been tested with non-English speakers and evaluated for acceptability and usability. This study describes the cultural and linguistic adaptation and evaluation of a family health history tool (VICKY: VIrtual Counselor for Knowing Your Family History) for Spanish speakers. In-depth interviews were conducted with 56 Spanish-speaking participants; a subset of 30 also participated in a qualitative component to evaluate the acceptability and usability of Spanish VICKY. Overall, agreement in family history assessment was moderate between VICKY and a genetic counselor (weighted kappa range: 0.4695 for stroke-0.6615 for heart disease), although this varied across disease subtypes. Participants felt comfortable using VICKY and noted that VICKY was very likeable and possessed human-like characteristics. They reported that VICKY was very easy to navigate, felt that the instructions were very clear, and thought that the time it took to use the tool was just right. Spanish VICKY may be useful as a tool to collect family health history and was viewed as acceptable and usable. The study results shed light on some cultural differences that may influence interactions with family history tools and inform future research aimed at designing and testing culturally and linguistically diverse digital systems.

Health Literacy and Income Mediate Racial/Ethnic Asthma Disparities.

BACKGROUND: Health literacy and socioeconomic status (SES) are associated with both race/ethnicity and asthma outcomes. The extent to which health literacy and SES mediate racial/ethnic asthma disparities is less clear. OBJECTIVE: To determine if health literacy and SES mediate racial/ethnic asthma disparities using advanced mediation analyses. METHODS: A secondary analysis was performed using a Chicago-based longitudinal cohort study conducted from 2004 to 2007 involving 342 adults age 18 to 41 years with persistent asthma. Phone interviews were conducted every 3 months assessing asthma quality of life (AQOL; scored 1-7, with 7 being the highest) and asthma-related health care use measures. Structural equation models assessed mediation of race/ethnicity effects on AQOL and health care use through health literacy and SES. Covariates in the best-fit model included sex, year and season of interview, and cigarette smoking. KEY RESULTS: The study sample was 77.8% female, 57.3% African American/non-Hispanic, and 28.7% Hispanic. Race/ethnicity was significantly associated with AQOL and asthma-related emergency department (ED) visits, but only indirectly, through the effects of health literacy and income. Compared with White/non-Hispanics, African American/non-Hispanics and Hispanics had significantly higher odds of low health literacy and lower income. Low health literacy was associated with significantly lower AQOL scores (ß = -0.24, 95% confidence interval (CI) [-0.38, -0.10]) and higher odds of an ED visit (adjusted odds ratio = 1.24, 95% CI [1.07, 1.43]). Increasing income was associated with significantly higher AQOL scores (ß = 0.18, 95% CI [0.08, 0.28]) and lower odds of an ED visit (adjusted odds ratio = 0.88, 95% CI [0.80, 0.97]). CONCLUSIONS: The relationships between race/ethnicity and several asthma outcomes were mediated by health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers. [HLRP: Health Literacy Research and Practice. 2019;3(1):e9-e18.]. PLAIN LANGUAGE SUMMARY: Using advanced statistical methods, this study suggests racial/ethnic differences in several asthma outcomes are largely due to effects of health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers.

Assessment of Preclinical Liver and Skeletal Muscle Biomarkers Following Clofibrate Administration in Wistar Rats.

Clofibrate is a known rodent hepatotoxicant classically associated with hepatocellular hypertrophy and increased serum activities of cellular alanine aminotransferase/aspartate aminotransferase (ALT/AST) in the absence of microscopic hepatocellular degeneration. At toxic dose, clofibrate induces liver and skeletal muscle injury. The objective of this study was to assess novel liver and skeletal muscle biomarkers following clofibrate administration in Wistar rats at different dose levels for 7 days. In addition to classical biomarkers, liver injury was assessed by cytokeratin 18 (CK18) cleaved form, high-mobility group box 1, arginase 1 (ARG1), microRNA 122 (miR-122), and glutamate dehydrogenase. Skeletal muscle injury was evaluated with fatty acid binding protein 3 (Fabp3) and myosin light chain 3 (Myl3). Clofibrate-induced hepatocellular hypertrophy and skeletal muscle degeneration (type I rich muscles) were noted microscopically. CK, Fabp3, and Myl3 elevations correlated to myofiber degeneration. Fabp3 and Myl3 outperformed CK for detection of myofiber degeneration of minimal severity. miR-122 and ARG1 results were significantly correlated and indicated the absence of liver toxicity at low doses of clofibrate, despite increased ALT/AST activities. Moreover, combining classical and novel biomarkers (Fabp3, Myl3, ARG1, and miR-122) can be considered a valuable strategy for differentiating increased transaminases due to liver toxicity from skeletal muscle toxicity.

Patient Activation Mediates Health Literacy Associated with Hospital Utilization among Whites.

BACKGROUND: Reducing the 30-day hospital readmission rate is a national priority and patient activation has emerged as a modifiable target to reduce hospital readmissions. OBJECTIVE: Prior studies demonstrate that low patient activation and low health literacy are each associated with higher rates of hospital utilization. The aim of this study was to use path analysis methods to assess if patient activation mediates the relationship between health literacy and hospital utilization in the 30 days after discharge. DESIGN AND PARTICIPANTS: We performed a secondary analysis of data from a randomized controlled trial of patients receiving care at an urban safety net hospital. Path analyses were used to assess patient activation as a mediator of the relationship of education and health literacy with 30-day hospital utilization. The final model was stratified by race and ethnicity. MEASURE: 30 day Hospital Utilization. RESULTS: In the overall study sample, a one standard deviation (SD) higher patient activation measure (PAM) score was associated with 18% reduced odds of hospital utilization (odds ratio (OR) 0.82, 95% confidence interval (CI): 0.73, 0.91, p=<0.001). PAM mediated the relationship between education level and health literacy and hospital utilization. When stratified by race, the mediating effect of PAM was evident among Whites, but not among non-Whites. Specifically, a one SD higher PAM score was significantly associated with a 33% reduced odds of utilization among Whites (OR 0.67, 95% CI: 0.57, 0.79, p<0.001). With the inclusion of PAM in the model, there was no direct relationship between either health literacy or education and 30-day hospital utilization. CONCLUSION: Patient activation is only associated with hospital utilization among Whites. Further research is needed to assess if this selective protection is seen in other cohorts. Potential interventions to reduce hospital readmissions may need to consider other modifiable factors in racially and ethnically diverse populations.

Health Literacy and Education as Mediators of Racial Disparities in Patient Activation Within an Elderly Patient Cohort.

The Patient Activation Measure (PAM) assesses facets of patient engagement to identify proactive health behaviors and is an important predictor of health outcomes. Health literacy and education are also important for patient participation and successful navigation of the health care system. Because health literacy, education, and patient activation are associated with racial disparities, we sought to investigate whether health literacy and education would mediate racial differences in patient activation. Participants were 265 older adults who participated in a computer-based exercise interventional study. Health literacy was assessed using the Test of Functional Health Literacy in Adults (TOFHLA). Of 210 eligible participants, 72% self-identified as Black and 28% as White. In adjusted analyses, education and health literacy each significantly reduced racial differences in patient activation. These findings are especially important when considering emerging data on the significance of patient activation and new strategies to increase patient engagement.

Disparities in Age-Associated Cognitive Decline Between African-American and Caucasian Populations: The Roles of Health Literacy and Education.

OBJECTIVES: To examine health literacy as a mediator of racial disparities in cognitive decline as measured by executive function in elderly adults. DESIGN: Prospective cohort study. SETTING: Secondary analysis of ElderWalk trial in Boston, Massachusetts. PARTICIPANTS: English-speaking African-American and Caucasian individuals in a walking intervention for community-dwelling adults aged 65 and older without dementia at baseline who completed baseline and 12-month evaluations (N = 198). MEASUREMENTS: Health literacy was measured using the Short Test of Functional Health Literacy in Adults. Fluid and crystallized cognitive functions were measured at baseline and 12 months using the Trail-Making Test Part B minus Part B (TMT B-A) and the Controlled Oral Word Association Test (COWAT). Associations between health literacy and 12-month cognitive decline were modeled using multivariate linear regression. RESULTS: Participants with higher health literacy and education experienced less cognitive decline than those with limited health literacy according to the TMT B-A (P = .01). After adjusting for covariates, Caucasian participants (n = 63) experienced less decline than African-American participants (n = 135) on TMT B-A (P = .001) and COWAT (P = .001). Adjusting for health literacy led to a 25.3% decrease in the point estimate for racial difference in TMT B-A and a 19.5% decrease in COWAT. Although independently related to cognitive decline, educational attainment did not mediate racial differences. CONCLUSION: Health literacy is a partial mediator of racial disparities in cognitive decline. These results indicate the need to develop interventions to mitigate cognitive decline that individuals with low heath literacy can use and to modify the healthcare environment to better accommodate this population.