Assessment and validation of glottic motion using cone-beam CT and real-time cine MRI.

PURPOSE: This study aimed to assess the margin for the planning target volume (PTV) using the Van Herk formula. We then validated the proposed margin by real-time magnetic resonance imaging (MRI). METHODS: An analysis of cone-beam computed tomography (CBCT) data from early glottic cancer patients was performed to evaluate organ motion. Deformed clinical target volumes (CTV) after rigid registration were acquired using the Velocity program (Varian Medical Systems, Palo Alto, CA, USA). Systematic (Σ) and random errors (σ) were evaluated. The margin for the PTV was defined as 2.5 Σ + 0.7 σ according to the Van Herk formula. To validate this margin, we accrued healthy volunteers. Sagittal real-time cine MRI was conducted using the ViewRay system (ViewRay Inc., Oakwood Village, OH, USA). Within the obtained sagittal images, the vocal cord was delineated. The movement of the vocal cord was summed up and considered as the internal target volume (ITV). We then assessed the degree of overlap between the ITV and the PTV (vocal cord plus margins) by calculating the volume overlap ratio, represented as (ITV∩PTV)/ITV. RESULTS: CBCTs of 17 early glottic patients were analyzed. Σ and σ were 0.55 and 0.57 for left-right (LR), 0.70 and 0.60 for anterior-posterior (AP), and 1.84 and 1.04 for superior-inferior (SI), respectively. The calculated margin was 1.8 mm (LR), 2.2 mm (AP), and 5.3 mm (SI). Four healthy volunteers participated for validation. A margin of 3 mm (AP) and 5 mm (SI) was applied to the vocal cord as the PTV. The average volume overlap ratio between ITV and PTV was 0.92 (range 0.85-0.99) without swallowing and 0.77 (range 0.70-0.88) with swallowing. CONCLUSION: By evaluating organ motion by using CBCT, the margin was 1.8 (LR), 2.2 (AP), and 5.3 mm (SI). The margin acquired using CBCT fitted well in real-time cine MRI. Given that swallowing during radiotherapy can result in a substantial displacement, it is crucial to consider strategies aimed at minimizing swallowing and related motion.

Specialist Availability and Drug Adherence in Older Adults with Dementia Across Regions of the United States.

BACKGROUND: Access to specialists facilitates appropriate Alzheimer's disease and related dementia (ADRD) medication use and adherence. However, there is little information on the impact of specialists' availability on ADRD medication adherence, especially in regions of the United States (US) where specialists are scarce, e.g., the Deep South (DS). OBJECTIVE: To ascertain whether the availability of specialty physicians in the DS and other US regions predicts ADRD medication adherence among community-dwelling older adultsMethods:We conducted secondary analyses of claims data for 54,194 Medicare beneficiaries with ADRD in 2013-2015. Medication adherence was measured using the proportion of days covered (PDC). Multivariable-adjusted Modified Poisson regression was used to examine associations of adherence with physicians' availability by region. RESULTS: The race/ethnicity distribution was 81.44% white, 9.17% black, 6.24% Hispanic, 2.25% Asian, and 1% other; 71.81% were female, and 42.36% were older than 85 years. Beneficiaries across regions differed in all individual and contextual characteristics except sex and comorbidities. Neurologists and psychiatrists' availability was not significantly associated with adherence (DS = 1.00, 0.97-1.03 & non-DS = 1.01, 1.00-1.01). Race and having ≥1 specialist visits were associated with a lower risk of adherence in both regions (p < 0.0001). Advanced age, dual Medicare/Medicaid eligibility, and living in non-large metropolitan areas, were associated with adherence in the non-DS region. CONCLUSION: Among older Americans with ADRD, a context defined by specialist availability does not affect adherence, but other context characteristics related to socioeconomic status may. Research should further examine the influence of individual and contextual factors on ADRD treatment among older adults.

Attitudes toward telemedicine among urban and rural residents.

INTRODUCTION: Adoption of telemedicine by healthcare facilities has dramatically increased since the start of coronavirus pandemic; yet, major differences exist in universal acceptance of telemedicine across different population groups. The goal of this study was to examine population-based factors associated with current and/or future use of telemedicine in Alabama. METHODS: A cross-sectional survey was administered to 532 participants online or by phone, in four urban and eight rural counties in Alabama. Data were collected on: demographics, health insurance coverage, medical history, access to technology, and its use in accessing healthcare services. Generalized logit regression models were used to estimate the odds of choosing "virtual visit" and "phone communication" compared to "in-person visit" for the preferred choice of visit with the healthcare provider; as well as odds for willingness to participate in "virtual visit" in the future. RESULTS: Our study sample had a mean age of 43 (±15) years, 72.9% women, 45.9% Black or African American; 59.4% population living in an urban county. The odds of "phone communication" were higher compared to the odds of "in-person visit", with a unit increase in age (odds ratio: 1.02, 95% confidence interval: 1.00-1.03), after adjusting for other covariates. Among participants with past experience of virtual communications, the odds for choosing "virtual visit" were significantly higher compared to choice of in-person visit (odds ratio for virtual visit: 3.23, 95% confidence interval: 2.01-5.18), adjusted for other covariates. Further, people with college or more education were 71% less likely to choose "No" compared to those with high school or lower general education development education for future virtual visit [odds ratio for college or more: 0.29, 95% confodence interval: 0.10-0.87). Likewise, participants residing in rural counties were 57% less likely to choose "No" compared to urban counties for future virtual visit (odds ratio for rural participants: 0.43, 95% confidence interval:0.19-0.97). DISCUSSION: Our study found notable differences in age, education, and rurality for use and/or preference for telemedicine. Medical institutions and healthcare providers will need to account for these differences to ensure that the implementation of telemedicine does not exacerbate existing health disparities.

A Radiological Assessment of Chronic Subdural Hematomas.

Chronic subdural hematoma (CSDH), which generally occurs in elderly patients, is a frequently diagnosed condition in neurosurgical departments. Computed tomography (CT) and magnetic resonance imaging (MRI) are the most preferred diagnostic modalities for CSDH assessment. With early diagnosis and adequate management, CSDH may show favorable prognosis in majority of the patients; however, recurrence after surgery can occur in a significant number of patients. The recently increasing number of CSDH studies could reveal the prognostic factors affecting CSDH recurrence. Particularly, radiological characteristics regarding the internal architecture of CSDH are considered closely associated with recurrence in surgically treated CSDH patients. In this literature review, we evaluated the various diagnostic modalities of CSDH and its radiological characteristics on CT and MRI. Furthermore, we summarized the prognostic factors of recurrence for the hematoma type based on the radiological findings.

Cost-effective screening using a two-antibody panel for detecting mismatch repair deficiency in sporadic colorectal cancer.

BACKGROUND: The microsatellite instability (MSI) test and immunohistochemistry (IHC) are widely used to screen DNA mismatch repair (MMR) deficiency in sporadic colorectal cancer (CRC). For IHC, a two-antibody panel of MLH1 and MSH2 or four-antibody panel of MLH1, MSH2, PMS2, and MSH6 are used. In general, MSI is known as a more accurate screening test than IHC. AIM: To compare two- and four-antibody panels of IHC in terms of accuracy and cost benefit on the basis of MSI testing for detecting MMR deficiency. METHODS: We retrospectively analyzed patients with CRC who underwent curative surgery between 2015 and 2017 at a tertiary referral center. Both IHC with four antibodies and MSI tests were routinely performed. The sensitivity and specificity of a four- and two types of two-antibody panels (PMS2/MSH6 and MLH1/MSH2) were compared on the basis of MSI testing for detecting MMR deficiency. RESULTS: High-frequency MSI was found in 5.5% (n = 193) of the patients (n = 3486). The sensitivities of the four- and two types of two-antibody panels were 97.4%, 92.2%, and 87.6%, respectively. The specificities of the three types of panels did not differ significantly (99.6% for the four-antibody and PMS2/MSH6 panels, 99.7% for the MLH1/MSH2 panel). Based on Cohen's kappa statistic (κ), four- and two-antibody panels were in almost perfect agreement with the MSI test (κ > 0.9). The costs of the MSI test and the four- and two-antibody panels of IHC were approximately $200, $160, and $80, respectively. CONCLUSION: Considering the cost of the four-antibody panel IHC compared to that of the two-antibody panel IHC, a two-antibody panel of PMS2/MSH6 might be the best choice in terms of balancing cost-effectiveness and accuracy.

Impacts of Residual Self-Interference, Hardware Impairment and Cascade Rayleigh Fading on the Performance of Full-Duplex Vehicle-to-Vehicle Relay Systems.

In practice, self-interference (SI) in full-duplex (FD) wireless communication systems cannot be completely eliminated due to imperfections in different factors, such as the SI channel estimation and hardware circuits. Therefore, residual SI (RSI) always exists in FD systems. In addition, hardware impairments (HIs) cannot be avoided in FD systems due to the non-ideal characteristics of electronic components. These issues motivate us to consider an FD-HI system with a decode-and-forward (DF) relay that is applied for vehicle-to-vehicle (V2V) communication. Unlike previous works, the performance of the proposed FD-HI-V2V system is evaluated over cascaded Rayleigh fading channels (CRFCs). We mathematically obtain the exact closed-form expressions of the outage probability (OP), system throughput (ST), and ergodic capacity (EC) of the proposed FD-HI-V2V system under the joint and crossed effects of the RSI, HIs, and CRFCs. We validate all derived expressions via Monte-Carlo simulations. Based on these expressions, the OP, ST, and EC of the proposed FD-HI-V2V system are investigated and compared with other related systems, such as ideal hardware (ID) and half-duplex (HD) systems, as well as a system over traditional Rayleigh fading channels (RFCs), to clearly show the impacts of negative factors.

Dementia Care in Diverse Older Adults in the U.S. Deep South and the Rest of the United States.

BACKGROUND: Use of specialists and recommended drugs has beneficial effects for older adults living with Alzheimer's disease and related dementia (ADRD). Gaps in care may exist for minorities, e.g., Blacks, and especially in the United States (U.S.) Deep South (DS), a poor U.S. region with rising ADRD cases and minority overrepresentation. Currently, we have little understanding of ADRD care utilization in diverse populations in this region and elsewhere in the U.S. (non-DS), and the factors that adversely impact it. OBJECTIVE: To examine utilization of specialists and ADRD drugs (outcomes) in racial/ethnic groups of older adults with ADRD and the personal or context-level factors affecting these outcomes in DS and non-DS. METHODS: We obtained outcomes and personal-level covariates from claims for 127,512 Medicare beneficiaries with ADRD in 2013-2015, and combined county-level data in exploratory factor analysis to define context-level covariates. Adjusted analyses tested significant association of outcomes with Black/White race and other factors in DS and non-DS. RESULTS: Across racial/ethnic groups, 33%-43% in DS and 43%-50% in non-DS used specialists; 47%-55% in DS and 41%-48% in non-DS used ADRD drugs. In adjusted analyses, differences between Blacks and Whites were not significant. Vascular dementia, comorbidities, poverty, and context-level factor "Availability of Medical Resources" were associated with specialist use; Alzheimer's disease and senile dementia, comorbidities, and specialist use were associated with drug use. In non-DS only, other individual, context-level covariates were associated with the outcomes. CONCLUSION: We did not observe significant gaps in ADRD care in DS and non-DS; however, research should further examine determinants of low specialist and drug use in these regions.

Comparison of Patient Experience Between Primary Care Settings Tailored for Homeless Clientele and Mainstream Care Settings.

BACKGROUND: More than 1 million Americans receive primary care from federal homeless health care programs yearly. Vulnerabilities that can make care challenging include pain, addiction, psychological distress, and a lack of shelter. Research on the effectiveness of tailoring services for this population is limited. OBJECTIVE: The aim was to examine whether homeless-tailored primary care programs offer a superior patient experience compared with nontailored ("mainstream") programs overall, and for highly vulnerable patients. RESEARCH DESIGN: National patient survey comparing 26 US Department of Veterans Affairs (VA) Medical Centers' homeless-tailored primary care ("H-PACT"s) to mainstream primary care ("mainstream PACT"s) at the same locations. PARTICIPANTS: A total of 5766 homeless-experienced veterans. MEASURES: Primary care experience on 4 scales: Patient-Clinician Relationship, Cooperation, Accessibility/Coordination, and Homeless-Specific Needs. Mean scores (range: 1-4) were calculated and dichotomized as unfavorable versus not. We counted key vulnerabilities (chronic pain, unsheltered homelessness, severe psychological distress, and history of overdose, 0-4), and categorized homeless-experienced veterans as having fewer (≤1) and more (≥2) vulnerabilities. RESULTS: H-PACTs outscored mainstream PACTs on all scales (all P<0.001). Unfavorable care experiences were more common in mainstream PACTs compared with H-PACTs, with adjusted risk differences of 11.9% (95% CI=6.3-17.4), 12.6% (6.2-19.1), 11.7% (6.0-17.3), and 12.6% (6.2-19.1) for Relationship, Cooperation, Access/Coordination, and Homeless-Specific Needs, respectively. For the Relationship and Cooperation scales, H-PACTs were associated with a greater reduction in unfavorable experience for patients with ≥2 vulnerabilities versus ≤1 (interaction P<0.0001). CONCLUSIONS: Organizations that offer primary care for persons experiencing homelessness can improve the primary care experience by tailoring the design and delivery of services.

Perceptions of Care Coordination Among Homeless Veterans Receiving Medical Care in the Veterans Health Administration and Community Care Settings: Results From a National Survey.

BACKGROUND: Initiatives to expand Veterans' access to purchased health care outside Veterans Health Administration (VHA) facilities ("community care") present care coordination challenges for Veterans experiencing homelessness. OBJECTIVE: Among Veterans with homeless experiences, to evaluate community care use and satisfaction, and compare perceptions of care coordination among Veterans using VHA services and community care to those using VHA services without community care. RESEARCH DESIGN: Cross-sectional analysis of responses to a 2018 mailed survey. SUBJECTS: VHA outpatients with homeless experiences. MEASURES: Self-reported use of community care, Likert-style ratings of satisfaction with that care, and Access/Coordination experiences from the Primary Care Quality-Homeless (PCQ-H) survey. RESULTS: Of 4777 respondents, 1325 (26.7%) reported using community care; most of this subsample affirmed satisfaction with the community care they received (83%) and its timeliness (75%). After covariate adjustment, Veteran characteristics associated with greater community care use included female sex, being of retirement age and nonmarried, and having higher education, more financial hardship, ≥3 chronic conditions, psychological distress, depression, and posttraumatic stress disorder. Satisfaction with community care was lower among patients with travel barriers, psychological distress, and less social support. Compared with those using the VHA without community care, Veterans using VHA services and community care were more likely to report unfavorable access/coordination experiences [odds ratio (OR)=1.34, confidence interval (CI)=1.15-1.57]. This included hassles following referral (OR=1.37, CI=1.14-1.65) and perceived delays in receiving health care (OR=1.38, CI=1.19-1.61). CONCLUSIONS: Veterans with homeless experiences value community care options. Potential access benefits are balanced with risks of unfavorable coordination experiences for vulnerable Veterans with limited resources.

Willingness of Latinx and African Americans to Participate in Nontherapeutic Trials: It Depends on Who Runs the Research.

Background: Inclusion of racial/ethnic minorities in cancer-related research remains inadequate, continuing to impact disparate health outcomes. Data regarding enrollment of racial/ethnic minorities in nontherapeutic, health-related research is sparse, and even less is known about enrollment of those with a double disparity of racial/ethnic minorities in rural settings. Objective: To examine perspectives of Latinx and African American (AA) healthy volunteers from rural and urban settings in five southern US states and Puerto Rico regarding their trust in research and their willingness to participate in nontherapeutic research trials based on who conducts the research. Methods: This study was conducted in 2013 in rural and urban communities across Alabama, Florida, Georgia, Mississippi, Louisiana, and Puerto Rico. A 38-item questionnaire based on the Tuskegee Legacy Project Questionnaire assessed willingness, motivators, and barriers to participation in nontherapeutic cancer-related research. The sample was segmented into four subgroups by urban/rural location and race/ethnicity. Results: Of 553 participants (rural Latinx=151, urban Latinx=158, rural AA=122, urban AA=122), more than 90% had never been asked to participate in research, yet 75% of those asked agreed to participate. Most had positive views regarding health-related research. Trust in who conducted research varied by subgroup. Personal doctors and university hospitals were most trusted by all subgroups; for-profit and tobacco companies were least trusted. Both Latinx subgroups trusted pharmaceutical companies more than AAs; local hospitals and for-profit businesses were more trusted by AAs. Both rural subgroups trusted research by insurance companies more than their urban counterparts. Conclusions: If asked, rural and urban AA and Latinx healthy volunteers were willing to participate in health-related research, with personal doctors and university hospitals considered the most trusted sources to encourage/conduct research.

Gastric Cancer Risk Prediction Using an Epidemiological Risk Assessment Model and Polygenic Risk Score.

We investigated the performance of a gastric cancer (GC) risk assessment model in combination with single-nucleotide polymorphisms (SNPs) as a polygenic risk score (PRS) in consideration of Helicobacter pylori (H. pylori) infection status. Six SNPs identified from genome-wide association studies and a marginal association with GC in the study population were included in the PRS. Discrimination of the GC risk assessment model, PRS, and the combination of the two (PRS-GCS) were examined regarding incremental risk and the area under the receiver operating characteristic curve (AUC), with grouping according to H. pylori infection status. The GC risk assessment model score showed an association with GC, irrespective of H. pylori infection. Conversely, the PRS exhibited an association only for those with H. pylori infection. The PRS did not discriminate GC in those without H. pylori infection, whereas the GC risk assessment model showed a modest discrimination. Among individuals with H. pylori infection, discrimination by the GC risk assessment model and the PRS were comparable, with the PRS-GCS combination resulting in an increase in the AUC of 3%. In addition, the PRS-GCS classified more patients and fewer controls at the highest score quintile in those with H. pylori infection. Overall, the PRS-GCS improved the identification of a GC-susceptible population of people with H. pylori infection. In those without H. pylori infection, the GC risk assessment model was better at identifying the high-risk group.

HPV vaccine uptake among daughters of Latinx immigrant mothers: Findings from a cluster randomized controlled trial of a community-based, culturally relevant intervention.

OBJECTIVE: We examined the efficacy of a culturally relevant, community-based HPV vaccination intervention among Latinx immigrant mothers with daughters aged 9-12 in Alabama. METHODS: We conducted a cluster-randomized controlled trial with "place of residence" (e.g., apartment complexes, trailer parks) as the unit of randomization that evaluated two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating and appropriate nutrition label interpretation. Identical baseline/post/7-month follow up questionnaires were completed by all participants and both interventions consisted of four group sessions and one individual session. A total of 40 locations were randomized with 317 mother-daughter dyads enrolled in the study between May 2013 and October 2017. RESULTS: A total of 278 mother-daughter dyads met full eligibility and initiated the intervention/control participation. Retention rate overall was 93.2% (92.6% for the intervention arm and 93.7% for the control arm). Daughters in the intervention arm were significantly more likely to receive one, two, and three doses of HPV vaccine than daughters in the control arm p < 0.001). In multivariate analyses, mothers in the intervention arm had a six times greater odds of vaccinating daughters with the first dose (OR = 5.96, 95% CI: 3.38, 10.49), eight times greater odds of vaccinating daughters with the second dose (OR = 8.09, 95% CI: 4.0, 16.35), and more than 16 times greater odds of completing the three-dose HPV vaccine series than mothers in the control arm after adjusting for mother's age, time in the U.S., income, and daughter's health insurance status (OR = 16.5, 95% CI: 5.73, 47.48). Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1). CONCLUSIONS: A theory-driven, culturally-relevant intervention developed through extensive formative assessments in collaboration with community members can effectively promote HPV vaccination among 9-12 years of age daughters of Latina immigrants.

The Association of Low Income and High Stress with Acute Care Use in COPD Patients.

INTRODUCTION: Low-income chronic obstructive pulmonary disease (COPD) individuals are known to have higher rates of COPD-related hospitalizations and readmissions. Levels of psychological stress are also higher in low-income populations and may be associated with acute care use. We sought to: (1) determine the association between stress and acute care use in COPD, (2) evaluate the social determinants of health (SDH) in low and high stress individuals, and (3) determine the association between low income and high stress with acute care use. MATERIALS AND METHODS: Using results from a survey-based study of individuals with COPD at the University of Alabama (UAB), we used multivariable regression modeling to evaluate the association of high stress with acute care use (COPD-related emergency department [ED] visits or hospitalizations). We then compared SDH between low and high stress groups and evaluated the association of low income + high stress with acute care use in a secondary model. RESULTS: We included 126 individuals in our study. The high stress group was more likely to be < 65 years old and female. No differences in race, smoking, years of smoking, body mass index, dyspnea, or lung function (forced expiratory volume in 1 second [FEV1]%) by stress group were observed. The high stress group had a 2.5-fold increased adjusted odds of acute care use (adjusted odds ratio [AOR]95% confidence interval [CI], 2.51, 1.06-5.98) compared to the low stress group, while the low-income + high stress group had a 4-fold increased adjusted odds of acute care use (AOR, 95% CI, 4.38, 1.25-15-45) compared to high-income + low-stress group. CONCLUSIONS: Acute care use and stress are associated in COPD. These associations are more pronounced in the low-income + high stress population who disproportionately contribute to health care utilization and frequently lack the resources needed to cope with stress.

Development of a reverse transcription-loop-mediated isothermal amplification as a rapid early-detection method for novel SARS-CoV-2.

The previous outbreaks of SARS-CoV and MERS-CoV have led researchers to study the role of diagnostics in impediment of further spread and transmission. With the recent emergence of the novel SARS-CoV-2, the availability of rapid, sensitive, and reliable diagnostic methods is essential for disease control. Hence, we have developed a reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for the specific detection of SARS-CoV-2. The primer sets for RT-LAMP assay were designed to target the nucleocapsid gene of the viral RNA, and displayed a detection limit of 102 RNA copies close to that of qRT-PCR. Notably, the assay has exhibited a rapid detection span of 30 min combined with the colorimetric visualization. This test can detect specifically viral RNAs of the SARS-CoV-2 with no cross-reactivity to related coronaviruses, such as HCoV-229E, HCoV-NL63, HCoV-OC43, and MERS-CoV as well as human infectious influenza viruses (type B, H1N1pdm, H3N2, H5N1, H5N6, H5N8, and H7N9), and other respiratory disease-causing viruses (RSVA, RSVB, ADV, PIV, MPV, and HRV). Furthermore, the developed RT-LAMP assay has been evaluated using specimens collected from COVID-19 patients that exhibited high agreement to the qRT-PCR. Our RT-LAMP assay is simple to perform, less expensive, time-efficient, and can be used in clinical laboratories for preliminary detection of SARS-CoV-2 in suspected patients. In addition to the high sensitivity and specificity, this isothermal amplification conjugated with a single-tube colorimetric detection method may contribute to the public health responses and disease control, especially in the areas with limited laboratory capacities.

Clinical and cost-effectiveness of collaborative traditional Korean and Western medicine treatment for low back pain: A protocol for a prospective observational exploratory study.

BACKGROUND: In South Korea, a few patients with low back pain (LBP) are currently being treated with a combination of traditional Korean medicine (KM) and Western medicine (WM). Although a recent research has reported results regarding patient satisfaction and exploratory effectiveness, evidence of comparative effectiveness still needs to be reviewed. The aim of this study is to evaluate the clinical and cost-effectiveness of KM and WM collaborative treatment (CT) compared with that of sole treatment (ST) for patients with LBP in Korea. METHOD/DESIGN: This multisite, prospective observational comparative effectiveness research study is part of a nationwide pilot project for KM and WM collaboration launched by the Korean Ministry of Health and Welfare. The duration of the study is 8 weeks, and the target number of inclusion is 360 patients. Participants receive treatment according to their treatment plan, and a researcher conducts investigations thrice, every 4 weeks. In the final analysis, the merged data from the participants' questionnaire responses, hospital medical records, and administrative data, and Health Insurance Review and Assessment service data will be compared between the CT and ST groups. DISCUSSION: This study will provide clinical and economic information about CT for LBP, which might be a milestone for establishing future polices about this collaboration in Korea. TRIAL REGISTRATION: The study protocol has been registered with the Clinical Research Information Service (KCT0002827).

Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol.

BACKGROUND: Low-income and racial/ethnic minority mothers and their young children are at increased risk for obesity. Lack of access to evidence-based obesity prevention and treatment services further contributes to these disparities. METHODS: This two-arm, parallel, randomized controlled trial (RCT) tests the effectiveness of a simple obesity intervention (HABITS) delivered as part of ongoing home visitation services, compared to the existing home visitation services without obesity-related content on mothers' and children's obesity risks. HABITS focuses on habit formation and modifications of food and activity cues in the home to support habit formation. Habit formation is focused on improving five behaviors: 1) fruits/vegetables, 2) fried foods, 3) sugar-sweetened beverages, 4) physical activity and 5) self-monitoring. Participants will be 298 mothers (>50% African American; 100% low income) and their children (3-5yo at baseline) enrolled in a home visitation program in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS as part of their weekly home visits for 9 months. Assessments of mothers (weight, waist circumference, and habit strength of targeted behaviors), children (rate of weight gain), and the food/activity household environment will be conducted at enrollment, post-intervention (9 month), and one year post-intervention follow-up. DISCUSSION: This research is poised to have a substantial impact because the delivery modalities of current obesity efforts disproportionally restrict the reach and engagement of underserved, low-income children and their caregivers who are most at-risk for health and obesity disparities.

Quality Assessment of Randomized Controlled Trials of Moxibustion Using STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB).

OBJECTIVES: To assess the quality and completeness of published reports of randomized controlled trials (RCTs) of moxibustion. METHOD: We searched six databases to retrieve eligible RCTs of moxibustion published from 2000 to December 2015. We used the STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB) tool to assess the completeness of reporting of RCTs of moxibustion and evaluate the reporting quality of included RCTs. RESULTS: Thirty-four studies of moxibustion were analyzed using STRICTOM and ROB. Of the 34 studies, the completeness percentage of STRICTOM varied from 33% to 100% (mean 68%, median 67%). The completeness of STRICTOM items showed a rising tendency along with the publication year. The STRICTOM items of setting and context (14.7%), rationale for the control (17.6%), and response (26.4%) showed incomplete reporting. The number of RCTs that rated a low risk of bias for allocation concealment (n=6), blinding of participants and personnel (n=1), and blinding of outcome assessment (n=4) appeared to be small. CONCLUSION: The quality of reporting of RCTs of moxibustion remains incomplete according to the STRICTOM and ROB tool at present. Researchers should consider the STRICTOM and ROB for improving not only the completeness of reporting but also the study design. General guidelines for RCTs of moxibustion are also required.

Is the Reinitiation of Antiplatelet Agents Safe at 1 Week after Gastric Endoscopic Submucosal Dissection? Assessment of Bleeding Risk Using the Forrest Classification.

BACKGROUND/AIMS: Delayed bleeding after gastric endoscopic submucosal dissection (ESD) commonly occurs within 3 days, but it may also occur after 1 week following ESD, especially in antiplatelet agent users. We evaluated the risk of delayed bleeding in post-ESD ulcers using the Forrest classification. METHODS: Registry data on the Forrest classification of post-ESD ulcers (n=371) at 1 week or 2 weeks after ESD were retrospectively evaluated. The Forrest classification was categorized into two groups: increased risk (Forrest Ia to IIc) or low risk (Forrest III). The odds ratios (ORs) were calculated using logistic regression analysis. RESULTS: Among 371 post-ESD ulcers, one ulcer (0.3%) was classified as Forrest Ib, two (0.5%) as Forrest IIa, 17 (4.6%) as Forrest IIb, 172 (46.4%) as Forrest IIc, and 179 (48.2%) as Forrest III. The proportion of increased-risk ulcers was 72.2% (140/194) at 1 week after ESD, which decreased to 29.4% (52/177) at 2 weeks after ESD (p<0.001). In the multivariate analysis, a post-ESD ulcer at 1 week after ESD (OR, 7.54), younger age (OR, 2.17), and upper/middle ulcer location (OR, 2.05) were associated with increased-risk ulcers. CONCLUSIONS: One week after ESD, ulcers still have an increased risk of bleeding when assessed using the Forrest classification. This risk should be considered when resuming antiplatelet therapy.

Differences in Electronic Cigarette Awareness, Use History, and Advertisement Exposure Between Black and White Hospitalized Cigarette Smokers.

E-cigarette use has increased rapidly over the past decade. There is growing concern about e-cigarette use and advertising given limited regulation of these products. This cross-sectional study reports on data collected at baseline from hospitalized cigarette smokers (N=944) recruited in monthly cohorts between December 2012 and September 2013. Participants were queried regarding e-cigarette awareness and use, and number and sources of e-cigarette advertisement exposures in the previous 6 months. Most Whites (99%) reported ever hearing of an e-cigarette compared to 96% of Blacks (p<0.001). Over two thirds (64%) of Whites reported ever using an e-cigarette compared to 30% of Blacks (p<0.001). There were significant trends in increasing e-cigarette use for both racial groups with an average increase of 13% each month (p<0.005) and in increasing e-cigarette advertisement exposure reported for the previous 6 months, with a 14% increase each month (p<0.0001). Whites reported 56% greater advertisement exposure than Blacks (mean=25 vs. 8 in month 1 to 79 vs. 45 in month 9, respectively; p<0.0001). For Blacks, advertisement exposure was significantly associated with e-cigarette use (p<0.001). Whites reported more advertisement exposure from stores and the Internet, and Blacks reported more advertisement exposure from radio or television. Results suggest that e-cigarette marketing is beginning to breach the Black population who are, as a consequence, "catching up" with Whites with regard to e-cigarette use. Given the significant disparities for smoking-related morbidity and mortality between Blacks and Whites, these findings identify new areas for future research and policy.

Addressing the unexpected: lessons learned from a randomized controlled trial conducted in partnership with a low-income, rural community.

Healthy People 2020 objectives include increasing the proportion of individuals who are adherent to their hypertensive medications. In this paper we highlight lessons learned through the implementation of a clinical trial to evaluate a behavioral intervention to increase medication adherence in a rural, low-income, primarily African American community.