Feasibility and Acceptability of a Novel Intensive Care Unit Communication Intervention ("Let's Talk") and Initial Assessment Using the Multiple Goals Theory of Communication.

Background: Family members of intensive care unit (ICU) patients often report poor communication, feeling unprepared for ICU family meetings, and poor psychological outcomes after decision-making. The objective of this study was to create a tool to prepare families for ICU family meetings and assess feasibility of using Communication Quality Analysis (CQA) to measure communication quality of family meetings. Methods: This observational study was conducted at an academic tertiary care center in Hershey, PA from March 2019 to 2020. Phase 1a involved conceptual design. Phase 1b entailed acceptability testing of 2 versions of the tool (text-only, comic) with 9 family members of non-capacitated ICU patients; thematic analysis of semi-strucutred interviews was conducted. Phase 1c assessed feasibility of applying CQA to audio-recorded ICU family meetings (n = 17); 3 analysts used CQA to assess 6 domains of communication quality. Wilcoxon Signed Rank tests were used to interpret CQA scores. Results: Four themes emerged from Phase 1b interviews: participants 1) found the tool useful for meeting preparation and organizing thoughts, 2) appreciated emotional content, 3) preferred the comic form (67%), and 4) had indifferent or negative perceptions about specific elements. In Phase 1c, clinicians scored higher on the CQA content and engagement domains; family members scored higher on the emotion domain. CQA scores in the relationship and face domains had the lowest quality ratings. Conclusions: Let's Talk may help families become better prepared for ICU family meetings. CQA provides a feasible approach to assessing communication quality that identifies specific areas of strengths and weaknesses in communication.

Comparing two advance care planning conversation activities to motivate advance directive completion in underserved communities across the USA: The Project Talk Trial study protocol for a cluster, randomized controlled trial.

BACKGROUND: Advance care planning (ACP) is a process involving conversations between patients, loved ones, and healthcare providers that consider patient preferences for the types of medical therapies received at the end of life. Underserved populations, including Black, Hispanic, rural, and low-income communities are less likely to engage in ACP than other communities, a health inequity that results in lower-quality care and reduced hospice utilization. The purpose of this trial is to compare efficacy of two interventions intended to motivate ACP (particularly advance directive completion) for those living in underserved communities. METHODS: This 3-armed cluster, randomized controlled mixed methods design is being conducted in 75 community venues in underserved communities across the USA. The goal of the trial is to compare the efficacy of two interventions at motivating ACP. Arm 1 uses an end-of-life conversation game (Hello); Arm 2 uses a nationally utilized workshop format for ACP conversations (The Conversation Project); and Arm 3 uses an attention control game (TableTopics). Events are held in partnership with 75 local community-based host organizations and will involve 1500 participants (n=20 per event). The primary outcome is completion of a visually verified advance directive at 6 months post-event. Primary analyses compare efficacy of each intervention to each other and the control arm. Secondary mixed methods outcomes include (a) other ACP behaviors and engagement; (b) communication quality; (c) impact of sociocultural environment on ACP (via qualitative interviews); and (d) implementation and sustainability. Subgroup analyses examine outcomes for Black, Hispanic, and rural groups in particular. DISCUSSION: This trial will add to the evidence base behind various conversational ACP interventions, examine potential mechanisms of action for such interventions, and provide qualitative data to better understand the sociocultural environment of how community-based ACP interventions are experienced by underserved populations. Results will also provide important data for future researchers to learn whether visual verification of advance directives is necessary or whether reliance on self-reported outcomes is of comparable value. Data from this study will inform ways to effectively motivate underserved communities to participate in advance care planning. TRIAL REGISTRATION: ClinicalTrials.gov NCT04612738. Registered on October 12, 2020. All information from the WHO Trial Registration Data Set can be found within the protocol.

Robust and Efficient Assessment of Potency (REAP) as a quantitative tool for dose-response curve estimation.

The median-effect equation has been widely used to describe the dose-response relationship and identify compounds that activate or inhibit specific disease targets in contemporary drug discovery. However, the experimental data often contain extreme responses, which may significantly impair the estimation accuracy and impede valid quantitative assessment in the standard estimation procedure. To improve the quantitative estimation of the dose-response relationship, we introduce a novel approach based on robust beta regression. Substantive simulation studies under various scenarios demonstrate solid evidence that the proposed approach consistently provides robust estimation for the median-effect equation, particularly when there are extreme outcome observations. Moreover, simulation studies illustrate that the proposed approach also provides a narrower confidence interval, suggesting a higher power in statistical testing. Finally, to efficiently and conveniently perform common lab data analyses, we develop a freely accessible web-based analytic tool to facilitate the quantitative implementation of the proposed approach for the scientific community.

Finding a new drug which is both safe and efficient is an expensive and time-consuming endeavour. In particular, establishing the 'dose-effect relationship' ­ how beneficial a drug is at different dosages ­ can be challenging. Predicting this curve requires gathering experimental data by exposing and recording how cells respond to various levels of the drug. However, extreme values are often observed at low and high dosages, potentially introducing errors that are hard to correct in the prediction process. Yet, these extreme observations are sometimes genuine so researchers cannot just ignore them. To improve dose-effect estimation, Zhou, Liu, Fang et al. developed a new general-purpose approach. It uses advanced statistical modelling to account for extremes in lab data. This strategy outperformed other methods when dealing with these observations while also providing higher efficiency in data analysis with more uniform data in experiments. To facilitate implementation, Zhou, Liu, Fang et al. set up a user-friendly tool baptized 'REAP'; this free online resource allows scientists without advanced statistical experience to harness the new approach and to perform dose-effect analysis more easily and accurately. This could boost research across many different disciplines that examine the effects of chemicals on cells.

Cost evaluation of an exercise oncology intervention: The exercise in all chemotherapy trial.

BACKGROUND: There is strong evidence supporting the efficacy of exercise oncology programs to improve physical and psychosocial outcomes during active treatment. However, there is a paucity of evidence on the effect of exercise on healthcare utilization and cost analyzes of exercise oncology programs. AIMS: Our objective was to assess the effects of a pragmatic exercise oncology program (ENACT) during active chemotherapy treatment on healthcare utilization and associated costs. METHODS: We conducted post-hoc analyzes on 160 ENACT participants and 75 comparison participants matched on cancer site, stage, age range, and gender. We obtained complete healthcare utilization histories for each patient (specific to emergency department [ED] visits and hospital admissions) coinciding with their participation in ENACT. A sub-analysis was conducted for advanced stage breast, gastrointestinal, and pancreatic cancer patients. RESULTS: Healthcare costs for patients who participated in the ENACT exercise oncology intervention were numerically lower than healthcare costs for the comparison group, even after accounting for the cost of the intervention. However, the differences were not statistically significant. CONCLUSION: Our findings suggest that an exercise oncology program during active chemotherapy treatment are at least cost neutral for all cancer patients, including advanced stage cancers. Additional research is warranted to evaluate the potential for exercise oncology programs to reduce healthcare utilization, particularly in advanced cancer patients.

Cervical cancer screening varies by HPV vaccination status among a National Cohort of privately insured young women in the United States 2006-2016.

ABSTRACT: Human papillomavirus (HPV) vaccination in young women is low. Women aged 21 to 65 years in the United States (U.S.) have not reached the Healthy People 2020 objective of 93% for cervical cancer screening. The main aim of this study was to investigate the association between HPV vaccination status and cervical cancer screening among privately insured women aged 21 to 26 years in the U.S.This was a retrospective cohort study using the IBM MarketScan database (2006-2016). The study population included 190,982 HPV-vaccinated women and 763,928 matched unvaccinated women. Adjusted incidence rate ratio (IRR) and the 95% confidence intervals (CIs) were obtained using the generalized estimating equations models with a Poisson distribution.Among a total of 954,910 women included in the analysis, age (mean [SD]) was 23.3 [1.6] years. During 967,317 person-years of follow-up, a total of 475,702 incidents of cervical cancer screening were identified. The incidence density rates of cervical cancer screening were 461 per 1000 person-years (PY) for unvaccinated women and 787 per 1000 PY for those who received 3 doses of the HPV vaccine. After adjusting for other covariates, the IRR of cervical cancer screening was 34% higher among HPV-vaccinated women with at least one vaccine dose than unvaccinated women (adjusted IRR = 1.34, 95% CI: 1.33-1.35; P < .0001). The IRR of cervical cancer screening varied by the dose of HPV vaccination. There was evidence of a linear dose-response relationship between the number of HPV vaccine doses and cervical cancer screening (P-trend < .0001). Compared with unvaccinated women, the IRR of cervical cancer screening were 14%, 39%, and 60% higher among those who received 1, 2, and 3 doses of the HPV vaccine, respectively.In this large retrospective cohort study of privately insured women, HPV-vaccinated women were more likely to be screened for cervical cancer compared with unvaccinated women.

Global, regional and national epidemiology and prevalence of child stunting, wasting and underweight in low- and middle-income countries, 2006-2018.

In 2016, undernutrition, as manifested in childhood stunting, wasting, and underweight were estimated to cause over 1.0 million deaths, 3.9% of years of life lost, and 3.8% of disability-adjusted life years globally. The objective of this study is to estimate the prevalence of undernutrition in low- and middle-income countries (LMICs) using the 2006-2018 cross-sectional nationally representative demographic and health surveys (DHS) data and to explore the sources of regional variations. Anthropometric measurements of children 0-59 months of age from DHS in 62 LMICs worldwide were used. Complete information was available for height-for-age (n = 624,734), weight-for-height (n = 625,230) and weight-for-age (n = 626,130). Random-effects models were fit to estimate the pooled prevalence of stunting, wasting, and underweight. Sources of heterogeneity in the prevalence estimates were explored through subgroup meta-analyses and meta-regression using generalized linear mixed-effects models. Human development index (a country-specific composite index based on life expectancy, literacy, access to education and per capita gross domestic product) and the United Nations region were explored as potential sources of variation in undernutrition. The overall prevalence was 29.1% (95% CI 26.7%, 31.6%) for stunting, 6.3% (95% CI 4.6%, 8.2%) for wasting, and 13.7% (95% CI 10.9%, 16.9%) for underweight. Subgroup analyses suggested that Western Africa, Southern Asia, and Southeastern Asia had a substantially higher estimated prevalence of undernutrition than global average estimates. In multivariable meta-regression, a combination of human development index and United Nations region (a proxy for geographical variation) explained 54%, 56%, and 66% of the variation in stunting, wasting, and underweight prevalence, respectively. Our findings demonstrate that regional, subregional, and country disparities in undernutrition remain, and the residual gaps to close towards achieving the second sustainable development goal-ending undernutrition by 2030.

Low Skepticism and Positive Attitudes About Advance Care Planning Among African Americans: a National, Mixed Methods Cohort Study.

BACKGROUND: African Americans have low engagement in advance care planning (ACP). This has been attributed to healthcare distrust and skepticism about ACP. A better understanding of these attitudes is needed to address health disparities related to end-of-life care. OBJECTIVE: To explore the ACP-related values and beliefs of diverse African American communities across the USA and then the perceived value of an inexpensive end-of-life conversational game. DESIGN: Prospective, convergent, mixed methods cohort study involving fifteen underserved, African American communities across the USA. PARTICIPANTS: Of the 428 who attended events at purposively sampled sites, 90% consented to the research; 37% participated in one of 15 focus groups (n = 141). INTERVENTION: An end-of-life conversation game, played in groups of 4-6. MAIN MEASURES: The validated, 7-item ACP values and beliefs questionnaire (scaled 7 = least skeptical, 49 = most skeptical) was administered pre-game. Post-game focus groups explored perceptions about ACP and the intervention. KEY RESULTS: Participants had positive attitudes (low skepticism) about ACP with a median score of 12.00 (7.00, 20.00). Values and beliefs did not significantly differ by geographical region; however, rural areas were observed to be slightly more skeptical than urban areas (median score 14.00 vs. 11.00, p = 0.002). Themes from focus groups converged with survey data showing participants valued the ACP process and consider further engagement in ACP to be worthwhile. Subthemes emphasized the need for and value of ACP. CONCLUSIONS: Skepticism about ACP may contribute to low rates of ACP engagement in underserved African American communities. The positive attitudes uncovered in our study either negate previous findings or suggest reduced skepticism. TRIAL REGISTRATION: This study has been registered at clinicaltrials.gov ( NCT03456921 ).

Association of Participation in an End-of-Life Conversation Game With Advance Care Planning Behavior and Perspectives Among African American Individuals.

Importance: Less than 25% of African American individuals have completed advance directives and are thus vulnerable to poor end-of-life care. Low-cost interventions are needed to increase engagement in advance care planning (ACP). Objectives: To investigate whether an end-of-life conversation game motivates African American attendees to engage in ACP and to assess whether the game is well received and endorsed. Exposures: Attendance at an end-of-life conversation game (Hello) played in groups of 4 to 6 participants for 60 minutes. Design, Setting, and Participants: Prospective, mixed-methods cohort study conducted from 2018 to 2019 with a 3- to 11-month follow-up interview. Game events were held in 53 community venues across the US; 15 were purposively sampled for onsite research procedures. Of 428 attendees at purposively sampled sites, 386 (90%) consented to research procedures (6 attendees were removed from analysis for protocol deviation). Of 367 attendees who provided accurate contact information, 232 (63%) were contacted, and 220 were included in follow-up analyses. Main Outcomes and Measures: The primary outcome was advance directive completion rates after the intervention. Secondary outcomes included rates of other ACP behaviors, ACP engagement, conversation satisfaction and realism, and participants' Net Promoter Score (a measure of endorsement). Follow-up telephone interviews explored the game experience and relevant ACP behaviors of attendees. Results: Of 380 individuals who participated (mean [SD] age, 62.2 [13.8] years; 304 were female [80%], and 348 were [92%] African American), none withdrew because of an adverse event. After the intervention, 91 of 220 attendees (41%) completed a new advance directive; 176 of 220 attendees (80%) discussed end-of-life wishes with loved ones, and 214 of 219 attendees (98%) completed at least 1 ACP behavior. There was a moderate increase in the self-efficacy domain on the ACP Engagement Survey (mean [SD] change from before to after the game, 0.54 [0.98]; P < .001). The mean (SD) conversation satisfaction score was 6.21 (0.93) (range, 1-7, with 7 being highest satisfaction), and the overall Net Promoter Score was 57.89 (range, -100 to 100, with 100 being highest endorsement). Interviews revealed 5 themes about the game: (1) it was a useful forum for ACP; (2) it provided new information and perspective; (3) it was emotionally beneficial; (4) it increased appreciation for ACP; and (5) it empowered and motivated participants to perform ACP. Mixed-methods integration showed convergence across data sets. Conclusions and Relevance: Among a nationwide sample of African American individuals, the end-of-life conversation game appeared to be well received and was associated with high rates of ACP behavior. This low-cost and scalable tool may help reduce health disparities associated with end-of-life care.

Neighbourhood-level deprivation indices and postpartum women's health: results from the Community Child Health Network (CCHN) multi-site study.

BACKGROUND: Area-level socioeconomic characteristics have been shown to be related to health status and mortality however, little is known about the association between residential community characteristics in relation to postpartum women's health. METHODS: Data from the longitudinal, multi-site Community Child Health Network (CCHN) study were used. Postpartum women (n = 2510), aged 18-40 were recruited from 2008 to 2012 within a month of delivery. Socioeconomic data was used to create deprivation indices. Census data were analysed using principal components analysis (PCA) and logistic regression to assess the association between deprivation indices (DIs) and various health indicators. RESULTS: PCA resulted in two unique DIs that accounted for 67.5% of the total variance of the combined all-site area deprivation. The first DI was comprised of variables representing a high percentage of Hispanic or Latina, foreign-born individuals, dense households (more than one person per room of residence), with less than a high-school education, and who spent more than 30% of their income on housing costs. The second DI was comprised of a high percentage of African-Americans, single mothers, and high levels of unemployment. In a multivariate logistic regression model, using the quartiles of each DI, women who reside in the geographic area of Q4-Q2 of the second DI, were almost twice as likely to have more than three adverse health conditions compared to those who resided in the least deprived areas. (Q2vs.Q1:OR = 2.09,P = 0.001,Q3vs.Q1:OR = 1.89,P = 0.006,Q4vs.Q1:OR = 1.95,P = 0.004 respectively). CONCLUSIONS: Our results support the utility of examining deprivation indices as predictors of maternal postpartum health.

Post-Acute Kidney Injury Proteinuria and Subsequent Kidney Disease Progression: The Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI) Study.

Importance: Among patients who had acute kidney injury (AKI) during hospitalization, there is a need to improve risk prediction such that those at highest risk for subsequent loss of kidney function are identified for appropriate follow-up. Objective: To evaluate the association of post-AKI proteinuria with increased risk of future loss of renal function. Design, Setting, and Participants: The Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI) Study was a multicenter prospective cohort study including 4 clinical centers in North America included 1538 patients enrolled 3 months after hospital discharge between December 2009 and February 2015. Exposures: Urine albumin-to-creatinine ratio (ACR) quantified 3 months after hospital discharge. Main Outcomes and Measures: Kidney disease progression defined as halving of estimated glomerular filtration rate (eGFR) or end-stage renal disease. Results: Of the 1538 participants, 769 (50%) had AKI durring hospitalization. The baseline study visit took place at a mean (SD) 91 (23) days after discharge. The mean (SD) age was 65 (13) years; the median eGFR was 68 mL/min/1.73 m2; and the median urine ACR was 15 mg/g. Overall, 547 (37%) study participants were women and 195 (13%) were black. After a median follow-up of 4.7 years, 138 (9%) participants had kidney disease progression. Higher post-AKI urine ACR level was associated with increased risk of kidney disease progression (hazard ratio [HR], 1.53 for each doubling; 95% CI, 1.45-1.62), and urine ACR measurement was a strong discriminator for future kidney disease progression (C statistic, 0.82). The performance of urine ACR was stronger in patients who had had AKI than in those who had not (C statistic, 0.70). A comprehensive model of clinical risk factors (eGFR, blood pressure, and demographics) including ACR provided better discrimination for predicting kidney disease progression after hospital discharge among those who had had AKI (C statistic, 0.85) vs those who had not (C statistic, 0.76). In the entire matched cohort, after taking into account urine ACR, eGFR, demographics, and traditional chronic kidney risk factors determined 3 months after discharge, AKI (HR, 1.46; 95% CI, 0.51-4.13 for AKI vs non-AKI) or severity of AKI (HR, 1.54; 95% CI, 0.50-4.72 for AKI stage 1 vs non-AKI; HR, 0.56; 95% CI, 0.07-4.84 for AKI stage 2 vs non-AKI; HR, 2.24; 95% CI, 0.33-15.29 for AKI stage 3 vs non-AKI) was not independently associated with more rapid kidney disease progression. Conclusions and Relevance: Proteinuria level is a valuable risk-stratification tool in the post-AKI period. These results suggest there should be more widespread and routine quantification of proteinuria after hospitalized AKI.

Reproductive Life Planning and Contraceptive Action Planning for Privately Insured Women: The MyNewOptions Study.

CONTEXT: Although reproductive life planning (RLP) is recommended in federal and clinical guidelines and may help insured women make personalized contraceptive choices, it has not been systematically evaluated for effectiveness. METHODS: In 2014, some 984 privately insured women aged 18-40 who were not intending to become pregnant in the next year were randomly assigned to receive RLP, RLP with contraceptive action planning (RLP+) or information only (the control group). Women's contraceptive use, prescription contraceptive use, method adherence, switching to a more effective method, method satisfaction and contraceptive self-efficacy were assessed at six-month intervals during the two-year follow-up period. Differences between groups were identified using binomial logistic regression, linear regression and generalized estimating equation models. RESULTS: During the follow-up period, the proportion of women using any contraceptive method increased from 89% to 96%, and the proportion using a long-acting reversible contraceptive or sterilization increased from 8% to 19%. Contraceptive adherence was high (72-76%) in all three groups. In regression models, the sole significant finding was that women in the RLP+ group were more likely than those in the RLP group to use a prescription method (odds ratio, 1.3). No differences were evident between the intervention groups and the control group in overall contraceptive use, contraceptive adherence, switching to a more effective method, method satisfaction or contraceptive self-efficacy. CONCLUSIONS: The study does not provide evidence that web-based RLP influences contraceptive behaviors in insured women outside of the clinical setting. Further research is needed to identify strategies to help women of reproductive age identify contraceptive methods that meet their needs and preferences.

Cardiovascular and Metabolic Risk in Women in the First Year Postpartum: Allostatic Load as a Function of Race, Ethnicity, and Poverty Status.

OBJECTIVE: Allostatic load (AL) represents multisystem physiological "wear-and-tear" reflecting emerging chronic disease risk. We assessed AL during the first year postpartum in a diverse community sample with known health disparities. STUDY DESIGN: The Eunice Kennedy Shriver National Institute for Child Health and Human Development Community Child Health Network enrolled 2,448 predominantly low-income African-American, Latina, and White women immediately after delivery of liveborn infants at ≥20 weeks' gestation, following them over time with interviews, clinical measures, and biomarkers. AL at 6 and 12 months postpartum was measured by body mass index, waist:hip ratio, blood pressure, pulse, hemoglobin A1c, high-sensitive C-reactive protein, total cholesterol and high-density lipoprotein, and diurnal cortisol slope. RESULTS: Adverse AL health-risk profiles were significantly more prevalent among African-American women compared with non-Hispanic Whites, with Latinas intermediate. Breastfeeding was protective, particularly for White women. Complications of pregnancy were associated with higher AL, and disparities persisted or worsened through the first year postpartum. CONCLUSION: Adverse AL profiles occurred in a substantial proportion of postpartum women, and disparities did not improve from birth to 1 year. Breastfeeding was protective for the mother.

Joint modeling of recurrent events and a terminal event adjusted for zero inflation and a matched design.

In longitudinal studies, matched designs are often employed to control the potential confounding effects in the field of biomedical research and public health. Because of clinical interest, recurrent time-to-event data are captured during the follow-up. Meanwhile, the terminal event of death is always encountered, which should be taken into account for valid inference because of informative censoring. In some scenarios, a certain large portion of subjects may not have any recurrent events during the study period due to nonsusceptibility to events or censoring; thus, the zero-inflated nature of data should be considered in analysis. In this paper, a joint frailty model with recurrent events and death is proposed to adjust for zero inflation and matched designs. We incorporate 2 frailties to measure the dependency between subjects within a matched pair and that among recurrent events within each individual. By sharing the random effects, 2 event processes of recurrent events and death are dependent with each other. The maximum likelihood based approach is applied for parameter estimation, where the Monte Carlo expectation-maximization algorithm is adopted, and the corresponding R program is developed and available for public usage. In addition, alternative estimation methods such as Gaussian quadrature (PROC NLMIXED) and a Bayesian approach (PROC MCMC) are also considered for comparison to show our method's superiority. Extensive simulations are conducted, and a real data application on acute ischemic studies is provided in the end.

Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial.

BACKGROUND: The Affordable Care Act mandates that most women of reproductive age with private health insurance have full contraceptive coverage with no out-of-pocket costs, creating an actionable time for women to evaluate their contraceptive choices without cost considerations. The MyNewOptions study is a three-arm, randomized, controlled trial testing web-based interventions aimed at assisting privately insured women with making contraceptive choices that are consistent with their reproductive goals. METHODS: Privately insured women between the ages of 18 and 40 not intending pregnancy were randomly assigned to one of three groups: 1) a reproductive life planning (RLP) intervention, 2) a reproductive life planning enriched with contraceptive action planning (RLP+) intervention, or 3) an information only control group. Both the RLP and RLP+ guide women to identify their individualized reproductive goals and contraceptive method requirements. The RLP+ additionally includes a contraceptive action planning component, which uses if-then scenarios that allow the user to problem solve situations that make it difficult to be adherent to their contraceptive method. All three groups have access to a reproductive options library containing information about their contraceptive coverage and the attributes of alternative contraceptive methods. Women completed a baseline survey with follow-up surveys every 6 months for 2 years concurrent with intervention boosters. Study outcomes include contraceptive use and adherence. ClinicalTrials.gov identifier: NCT02100124. DISCUSSION: Results from the MyNewOptions study will demonstrate whether web-based reproductive life planning, with or without contraceptive action planning, helps insured women make patient-centered contraceptive choices compared with an information-only control condition.

Hip Hop Stroke: Study Protocol for a Randomized Controlled Trial to Address Stroke Literacy.

OBJECTIVE: Stroke is the fifth leading cause of death and the leading cause of serious long-term adult disability in the US. Acute stroke treatments with intravenous thrombolysis and endovascular therapy are proven to reduce disability, however a critical limitation on their effectiveness is the narrow time window for administration, which is 4.5 hours and 6 hours respectively from the onset of symptoms. Our overarching goal is to reduce pre-hospital delays to acute stroke treatments in economically disadvantaged minority communities where the greatest delays exist, using Hip Hop Stroke. METHODS: Hip Hop Stroke (HHS) is a school-based, child-mediated, culturally-tailored stroke communication multimedia intervention developed using validated models of behavior change and designed to improve stroke literacy (knowledge of stroke symptoms, the urgent need to call 911, and prevention measures) of 4th, 5th and 6th grade students and their parents residing in poor urban communities. Children in the intervention arm will receive the HHS intervention, while those in the attentional control arm will receive standardized nutrition education based on the USDA's MyPyramid program. Children will be trained and motivated to share stroke information with their parents or other adult caregiver. Both children and parents will complete a stroke knowledge assessment at baseline, immediately following the program, and at 3-months post-program. The primary outcome is the effect of the child mediation on parental stroke literacy. CONCLUSION: Stroke literate children, a captive audience in school systems, may represent a viable channel for spreading stroke information into households of poor urban communities where mass media stroke campaigns have shown the lowest penetration. These children may also call 911 when witnessing a stroke in their homes or communities. The HHS program may highlight the potential role of children in the chain of stroke recovery as a strategy for reducing prehospital delays to acute stroke treatment.

Validity of the brief inpatient screen for intimate partner violence among adult women.

BACKGROUND: Identifying intimate partner violence in healthcare settings is becoming the standard of care. The Brief Inpatient Screen was designed to assess recent emotional, physical, and sexual abuse in a general inpatient medical-surgical setting and compared to the Composite Abuse Scale. METHODS: Researchers matched "cases" (inpatients screening Brief Inpatient Screen-positive) to up to four "controls" (inpatients screening Brief Inpatient Screen-negative). Forty-six female hospital inpatients ages 18-64 years completed a self-administered survey. The sensitivity and specificity of the Brief Inpatient Screen and its subscales were compared to the Composite Abuse Scale. Researchers examined the performance of the Brief Inpatient Screen when used as a verbal screen versus an anonymous written screen. RESULTS: Twelve of 46 participants (26%) had a positive screen. Compared to the Composite Abuse Scale, the overall sensitivity and specificity of the verbal Brief Inpatient Screen were 52.6% (95% CI 28.9-75.6) and 92.6% (95% CI 75.7-99.1), respectively. The written Brief Inpatient Screen showed improved sensitivity overall (68.4%, 95% CI 43.5-87.4) for the most severe intimate partner violence. Subscale analysis revealed greater sensitivity for emotional and severe combined intimate partner violence. CONCLUSIONS: The verbal Brief Inpatient Screen, when compared to the Composite Abuse Scale, was limited in its ability to identify intimate partner violence. An anonymous written format improved sensitivity. Future research should optimize intimate partner violence screening among inpatients.

Quality of evidence in drug compendia supporting off-label use of typical and atypical antipsychotic medications.

Public and private payers use drug compendia to make coverage determinations, yet the quality of evidence they contain has received little scrutiny. We examined compendia citations regarding antipsychotic drugs, an important drug class given their substantial costs and widespread use. Nearly three-fold as many off-label indications were recommended for atypical as for typical agents, a difference that did not appear to be due to differences in quality of evidence for typical and atypical off-label indications. Given the important role that compendia play in evidence synthesis, coverage decisions, and ultimately, prescription utilization, these data suggest greater efforts are needed to improve the quality of evidence and transparency of evidence evaluations compendia contain.

The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial.

BACKGROUND: Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. OBJECTIVES: To test the effects of (1) CHESS+CM, a system for parents and children ages 4-12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. METHODS: We identified eligible parent-child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. RESULTS: Of 305 parent-child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child's Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = -0.31, 95% confidence limits [CL] -0.56, -0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL -0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL -8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM's effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). CONCLUSIONS: Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. TRIAL REGISTRATION: Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz).

The assessment, serial evaluation, and subsequent sequelae of acute kidney injury (ASSESS-AKI) study: design and methods.

BACKGROUND: The incidence of acute kidney injury (AKI) has been increasing over time and is associated with a high risk of short-term death. Previous studies on hospital-acquired AKI have important methodological limitations, especially their retrospective study designs and limited ability to control for potential confounding factors. METHODS: The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study was established to examine how a hospitalized episode of AKI independently affects the risk of chronic kidney disease development and progression, cardiovascular events, death, and other important patient-centered outcomes. This prospective study will enroll a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at three Clinical Research Centers, as well as 100 children undergoing cardiac surgery at three Clinical Research Centers. Participants will be followed for up to four years, and will undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens will be collected at each visit, along with information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography and urinalysis. CONCLUSIONS: ASSESS-AKI will characterize the short-term and long-term natural history of AKI, evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI, and identify a subset of high-risk patients who could be targeted for future clinical trials to improve outcomes after AKI.