Vancomycin-impregnated beads appear to be reasonable as a therapeutic option whereas amikacin-impregnated POP beads and amikacin and vancomycin combinations may require further study before considering as a therapeutic option.
<p class="Pa7"><strong>Introduction: </strong>Retention of racial/ethnic minority groups into research trials is necessary to fully understand and address health disparities. This study was conducted to identify participants’ characteristics associated with retention of African Americans (AAs) in a randomized controlled trial (RCT) of a behavioral intervention.</p><p class="Pa7"><strong>Methods: </strong>Using data from an RCT conducted from 2009 to 2012 among AAs, participant-level factors were examined for associations with retention between three measurement points (ie, baseline, 3-month, and 12-month). Chi-square tests and logistic regression analyses were conducted to compare retained participants to those who were not retained in order to identify important predictors of retention.</p><p class="Pa7"><strong>Results: </strong>About 57% of participants (n=238) were retained at 12 months. Baseline characteristics that showed a statistically significant association with retention status were age, marital status, body mass index (BMI), intervention group, enrollment of a partner in the study, and perceived stress score (PSS). Multivariable logistic regression that adjusted for age, BMI, and PSS showed the odds of being retained among participants who enrolled with a partner was 2.95 (95% CI: 1.87-4.65) compared with participants who had no study partner enrolled. The odds of being retained among participants who were obese and morbidly obese were .32 and .27 (95% CI: .14-.74 and .11-.69), respectively, compared with participants who had normal weight.</p><p><strong>Conclusion: </strong>Having a partner enrolled in behavioral interventions may improve retention of study participants. Researchers also need to be cognizant of participants’ obesity status and potentially target retention efforts toward these individuals. <em></em></p><p><em>Ethn Dis. </em>2017;27(3):265-272; doi:10.18865/ed.27.3.265.</p><strong></strong>
This study used ambient heart rate monitoring among health care workers to determine whether a novel measure of heart rate variability (HRV), as well as sleep disturbances, fatigue, or cognitive performance differed among non-rotating night shift nurses relative to those working permanent day shifts. Continuous ambulatory HRV monitoring was performed among night nurses (n = 11), and a comparison group of permanent day nurses (n = 7), over a 36-h period coinciding with the last two 12-h shifts of each participant's work week. Symptoms and psychomotor vigilance were assessed at the end of the ambient HRV monitoring period, and no differences between shifts were observed. Day nurses exhibited an increase in hourly mean HRV coherence ratios during their sleep period, suggesting a circadian pattern of cardiorespiratory phase coupling, whereas night nurses had no increase in HRV coherence ratios during their sleep period. The HRV coherence patterns were similar to high frequency HRV power among nurses on the same shift. To the authors knowledge, this study was the first to quantify patterns of the HRV coherence ratio among shiftworkers in a non-experimental (work/home) setting. The results suggest a pattern of autonomic dysregulation among night workers during their sleep period relative to those working day shifts. The HRV coherence ratio may serve as a novel indicator of HRV dysregulation among shift workers.
10099 Background: Late effects of cancer and its treatment include pain, fatigue, stress, and depression all mediated by autonomic dysfunction. Heart Rate Variability (HRV) coherence is an established measure of autonomic dysfunction. Cancer survivors have lower HRV coherence than normal controls. HRV biofeedback (HRV-B) training improves HRV coherence, restores autonomic health, and reduces the above symptoms. This report describes a feasibility study of HRV-B in symptomatic cancer survivors. Methods: In a randomized, waitlist controlled, clinical trial, 179 were screened, 34 enrolled and 31 completed the protocol. Participants in the intervention arm received weekly HRV-B training up to six weeks. Outcome measures assessed at baseline (pre) and after week six (post) included HRV coherence plus Insomnia Symptom Questionnaire (ISQ), Suscro Distress Inventory (SDI), Brief Pain Inventory (BPI), Multi-Dimensional Fatigue Inventory (MFI), Perceived Stress Scale (PSS) and Beck Depression Inventory II (BDI-II). Results: See table below. Conclusions: Delivering HRV Biofeedback training to cancer survivors is feasible at our Cancer Institute. This pilot study provides preliminary evidence that HRV-B for cancer survivors improves HRV coherence and reduces insomnia, pain, fatigue, depression, and stress. The intervention has great potential and further research is indicated. [Table: see text]
An anti-inflammatory dietary intervention called the Inflammation Management Intervention (IMAGINE) was adapted to emphasize watermelon due to its anti-inflammatory properties. This pilot study (n = 23) tested the effect of a watermelon-enhanced IMAGINE intervention (n = 15) on body habitus and markers of inflammation and metabolism. This 3-month self-selection trial, consisting of weekly in-person classes and online education for 12 weeks, focused on incorporating watermelon into an already anti-inflammatory diet. Controls (n = 8) received basic health education via email and blogs. Measurements, including diet, anthropometrics, actigraphy, and a blood draw, were made at baseline and immediately postintervention. Linear regression analyses were conducted using intervention status as the main exposure. Post hoc analyses then ignored intervention assignment and grouped participants based on their change in their energy-adjusted Dietary Inflammatory Index (E-DIITM) score. There were no group-by-time interactions for any of the studied outcomes. However, some intervention participants’ diets became more proinflammatory, and several control participants’ diets became more anti-inflammatory. Those participants below the median of E-DII change (ie, more anti-inflammatory changes) showed reductions in body fat percent (–1.27% vs +0.90%, respectively, P = .01), body mass index (–0.66 vs +0.38 kg/m2, respectively, P = .06) and body weight (–0.99 vs +0.54 kg, respectively, P = .08) compared to those above the median of E-DII change. This study demonstrates that individuals who adopt a more anti-inflammatory diet containing watermelon will have improvements in body anthropometrics. Future studies should focus on increasing adherence and compliance to intervention prescriptions, exploring options to extend interventions to evaluate long-term changes, and further examining changes in inflammatory biomarkers. Clinical Trials Registration: NCT03158740
Background: Recruitment and retention of minority racial/ethnic groups is necessary to assess and address cancer health disparities in the United States. The objective of this study was to characterize participants’ retention status and identify baseline participant factors associated with retention among an entirely African American (AA) population in a randomized controlled trial (RCT). Methods: Using data from the Healthy Eating and Living in the Spirit (HEALS) program, an RCT conducted from 2009 to 2012 among AAs in South Carolina we examined participant-level factors associated with retention. We used SAS v9.4 to compute chi square tests and fit logistic regressions in order to compare 220 (53.14%) retained to 194 not-retained participants with the goal of identifying important predictors of retention. Among the entire study population, main predictor variable of interest was network distance in miles from home of participants to the clinic venue (i.e. their church) whereas among participants randomized to the intervention arm, a second predictor was percentage of intervention classes attended. Results: Baseline characteristics that were significantly associated with retention status included group assignment, age, body mass index (BMI), distance from home to clinic site(s), and partner enrollment in the study. Participants who lived in locations >5 miles from the clinic sites were more likely to be retained in the study (OR = 1.58; 95% CI: 1.04 - 2.4) compared to participants who lived <5 miles away from the clinic. Older participants (>60 years) were 3.3 times as likely (95% CI: 1.59 - 6.81) than those aged < 41 years to be retained while individuals randomized to the control group were more likely to be retained (OR = 1.63; 95% CI: 1.06 - 2.50) compared with those randomized to the study group. Those who were obese were less likely to be retained (OR = 0.37; 95% CI: 0.17 - 0.79) compared to those who had normal BMI. Participants who had their partner enrolled in the study were less likely to be retained (OR = 0.59; 95% CI: 0.36-0.95) compared with participants who did not have their partners enrolled. Among individuals randomized to the intervention arm, attending 60% of the classes in the first 3 months of the RCT was strongly predictive of being retained in the study with an odds ratio of 4.31 (95% CI: 2.25 - 8.24) compared with those who did not complete 60% of the classes. Conclusions: Participants who lived further away (>5 miles) and attending 60% or more of the intervention classes was strongly predictive of being retained in the study. Ensuring that there is a run-in period as part of the screening procedure for all participants before randomization will help project managers to identify participants that are likely to be retained in the study and more studies need to be done to know why those who lived farther away were more likely to be retained. Citation Format: Oluwole A. Babatunde, Swann A. Adams, Michael D. Wirth, Jan M. Eberth, Jameson Sofge, Brook Harmon, Lisa Davis, Ruby Drayton, Tom Hurley, Heather M. Brandt, James R. Hebert. Predictors of participants’ retention among African Americans in the Healthy Eating and Living in The Spirit (HEALS) trial. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 1764.
148 Background: Late effects of cancer and its treatment include pain, fatigue, stress, and depression, all mediated by autonomic dysfunction. Heart Rate Variability (HRV) coherence is an established measure of optimal autonomic function. HRV coherence is achieved when the heart beat-to-beat intervals increase and decrease with respiration in a smooth rhythm. High coherence is associated with improved mood, cognition, executive function, and optimal pulmonary gas exchange. Cancer survivors have lower HRV than controls. Low HRV has been associated with early mortality, inflammation, and other adverse intermediary outcomes. HRV biofeedback (HRV-B) training improves HRV coherence, restores autonomic health, and reduces the above symptoms. HRV-B is non-pharmacologic, inexpensive, and self-maintained. This report describes a feasibility study of HRV-B in symptomatic cancer survivors. Methods: In a randomized, waitlist-controlled clinical trial, 179 were screened, 35 enrolled and 31 completed the protocol. Participants in the intervention arm received weekly HRV-B training up to six weeks. Outcome measures assessed at baseline (pre) and after week six (post) included HRV coherence plus the Brief Pain Inventory (BPI), Multi-Dimensional Fatigue Inventory (MFI), Perceived Stress Scale (PSS) and Beck Depression Inventory II (BDI-II). Data analyzed using linear-mixed models for repeated measures (SAS Proc Mixed). Results: Conclusions: Delivering HRV Biofeedback training to cancer survivors is feasible in a clinical setting. This study provides preliminary evidence that HRV-B training for cancer survivors improves HRV and reduces pain, fatigue, stress, and depression. HRV-B training has potential for symptom control in cancer survivors. Controlled, multisite studies are indicated.[Table: see text]
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