A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes.

PURPOSE: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. METHODS: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole-food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. RESULTS: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01), and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15-3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. CONCLUSION: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight, cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes.

PURPOSE: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC), and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet-promoting weight loss is feasible and might improve QOL. METHODS: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. RESULTS: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3 % total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8 % to 20.4 % percent calories from fat, p < 0.001) and fiber content (12.7 to 30.8 g fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95 % confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). CONCLUSIONS: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A Whole Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Feasibility, Nutrient, and Patient-Reported Outcomes.

Purpose: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC) and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet promoting weight loss is feasible and might improve QOL. Methods: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. Results: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3% total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8-20.4% percent calories from fat, p < 0.001) and fiber content (22.1 to 40.8 grams fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95% confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). Conclusions: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. Trial registration: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome.

Purpose: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. Methods: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. Results: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01) and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15 - 3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. Conclusion: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight and cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration: First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial.

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30 to 60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor-blinded randomized clinical trial (RCT) was designed to assess 1) preliminary efficacy (ie, alpha pre-specified at .2) of a wearable, app-controlled, transcutaneous electrical nerve stimulation (TENS) device for chronic CIPN and 2) feasibility of conducting a confirmatory trial within the National Cancer Institute Community Oncology Research Program (NCORP) (NCT04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0-10 numeric rating scales). The primary analysis was an analysis of covariance (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used a similar analysis of covariance models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at the endpoint (placebo-active) was 1.05 (95% Confidence Interval: -.56, 2.67; P = .199). The difference between groups for the individual symptoms was as follows: hot/burning pain: 1.37 (-.33, 3.08; P = .112), sharp/shooting pain: 1.21 (-.37, 2.79; P = .128), cramping: 1.35 (-.32, 3.02; P = .110), tingling: .23 (-.61, 1.08; P = .587), numbness: .27 (-.51, 1.05; P = .492). An RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in the NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PERSPECTIVE: Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.

Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial.

PURPOSE: A growing body of research suggests that inflammation plays a role in many chemotherapy-related toxicities such as fatigue, anxiety, and neuropathy. Regular exercise can change levels of individual cytokines (e.g., reducing IL-6, increasing IL-10); however, it is not known whether exercise during chemotherapy affects relationships between cytokines (i.e., whether cytokine concentrations change collectively vs. independently). This study assessed how 6 weeks of exercise during chemotherapy affected relationships between changes in concentrations of several cytokines. METHODS: This is a secondary analysis of a randomized trial studying 6 weeks of moderate-intensity walking and resistance exercise during chemotherapy compared with chemotherapy alone. At pre- and post-intervention, patients provided blood to assess serum concentrations of cytokines IL-1ß, IL-6, IL-8, IL-10, and IFN-γ, and receptor sTNFR1. We investigated relationships between cytokines using the correlations between changes in cytokine concentrations from pre- to post-intervention. RESULTS: We obtained complete data from 293 patients (149 randomized to exercise). Exercise strengthened the correlation between concentration changes of IL-10 and IL-6 (r = 0.44 in exercisers vs. 0.11 in controls; p = 0.001). We observed the same pattern for IL-10:IL-1ß and IL-10:sTNFR1. Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1ß (p = 0.099, trend-level significance). CONCLUSIONS: Our hypothesis-generating work suggests that regular exercise during 6 weeks of chemotherapy may cause certain cytokine concentrations to change collectively (not independently). This work enhances our understanding of relationships between cytokines and complements traditional analyses of cytokines in isolation. Future work should test for replication and relationships to patient outcomes. TRIAL REGISTRATION: Clinical Trials.gov, # NCT00924651, http://www.clinicaltrials.gov .

Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.

OBJECTIVE: Nearly 80% of cancer patients struggle with insomnia, which is associated with decreased heart rate variability (HRV) and quality of life (QOL). The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during chemotherapy visits, on QOL and HRV in patients with breast cancer (BC). METHOD: QOL and HRV data were obtained during a pilot clinical trial assessing the feasibility and effects of BBT-CI on insomnia. A total of 71 BC patients (mean age = 52.5 years) were randomly assigned to either BBT-CI or a healthy-eating control intervention (HEAL). BBT-CI and HEAL were delivered over 6 weeks (2 face-to-face sessions plus 4 phone calls) by trained staff at 4 National Cancer Institute-funded Community Oncology Research Program clinics. QOL was measured with the Functional Assessment of Cancer Therapy (FACT-G) and HRV with the Firstbeat device at baseline and after intervention. RESULTS: There were significant improvements in QOL after intervention for BBT-CI (FACT-G, p = .009; FACT-B, p = .016; ANCOVA) and 5-min supine HRV measures (SDNN, p = .005; rMSSD, p = .004; HF, p = .009; ANCOVA) compared with HEAL. CONCLUSIONS: Patients randomized to BBT-CI showed improvements in QOL and HRV, providing support for BBT-CI's possible benefit when delivered in the community oncology setting by trained staff. A more definitive efficacy trial of BBT-CI is currently being planned with sufficient statistical power to evaluate the intervention's clinical utility. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Multimedia psychoeducation for patients with cancer who are eligible for clinical trials: A randomized clinical trial.

BACKGROUND: Supporting patients' decision making about clinical trials may enhance trial participation. To date, few theory-based interventions have been tested to address this issue. The objective of the current study was aimed to evaluate the effect of a multimedia psychoeducation (MP) intervention, relative to a print education (PE) intervention, on patients' decision support needs and attitudes about clinical trials. METHODS: Patients with cancer who were eligible for participation in a National Cancer Institute therapeutic cancer clinical trial were recruited through the nationwide University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program from 2014 to 2016 and were randomized to the MP or PE intervention. Assessments at baseline (before intervention), postintervention, and at a 2-month follow-up visit included patients' decision support needs, attitudes regarding clinical trials, and clinical trial participation. RESULTS: In total, 418 patients with various types of cancer were recruited (ages 26-89 years). Relative to the PE intervention, the MP intervention did not significantly affect decision support needs. However, patients in the MP arm reported significantly more positive attitudes about clinical trials and were more likely to participate in a clinical trial than those in the PE arm (69% vs 62%; P = .01). Furthermore, an improvement in attitudes about clinical trials significantly mediated the effect of the intervention on participation in clinical trials. CONCLUSIONS: The MP intervention was able to improve patient attitudes toward clinical trials compared with the PE intervention, and this improvement led to increased rates of participation in trials. The MP intervention could be disseminated to improve attitudes about clinical trials among patients with cancer.

Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer.

OBJECTIVES: To assess an intervention derived from self-regulation theory (SRT) to promote well-being for individuals with advanced lung cancer. SAMPLE & SETTING: 45 adults with advanced lung cancer who were receiving chemotherapy at an ambulatory cancer center. METHODS & VARIABLES: Participants were randomized to the intervention group or usual care control group. Feasibility assessment focused on recruitment, retention, design, methods, and fidelity. Outcome measures of quality of life, symptoms, and distress were collected at four time points. The main research variables were symptoms, quality of life, and distress. RESULTS: The participation rate was 79%, and the retention rate was 62%. Participant loss was most often because of progressive disease and occurred early in the study. High fidelity was noted for delivery of the intervention as planned and outcome data collection by telephone. The mean number of interventions delivered was 5.5 of a planned 8. A high level of acceptability was reported for participants completing the intervention. IMPLICATIONS FOR NURSING: Although delivering the SRT-derived intervention with fidelity was possible, feasibility findings do not warrant intervention replication in this population.

Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial.

BACKGROUND: This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL). METHODS: Of the 71 participants recruited, 34 were randomised to receive BBT-CI and 37 to receive HEAL. Oncology staff was trained to deliver the intervention in four community clinics affiliated with the NCI. Insomnia was assessed with the Insomnia Severity Index (ISI), and circadian rhythm was assessed using a wrist-worn actiwatch. RESULTS: Community staff interveners delivered 72% of the intervention components, with a recruitment rate of 77% and an adherence rate of 73%, meeting acceptability and feasibility benchmarks. Those randomised to BBT-CI improved their ISI scores by 6.3 points compared to a 2.5-point improvement in those randomised to HEAL (P = 0.041). Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05). CONCLUSIONS: BBT-CI is an acceptable and feasible intervention that can be delivered directly in the community oncology setting by trained staff. The BBT-CI arm experienced significant improvements in insomnia and circadian rhythm as compared to the control condition.

Industry Payments to Obstetricians and Gynecologists Under the Sunshine Act.

OBJECTIVE: To evaluate financial relationships between obstetrician-gynecologists (ob-gyns) and industry, including the prevalence, magnitude, and the nature of payments. METHODS: We conducted a cross-sectional study in which we obtained a list of industry contributions to U.S. obstetricians and gynecologists through the Centers for Medicare and Medicaid Services Open Payments Database from August 1, 2013, to December 31, 2015. These data were cross-referenced with the entire cohort of practicing obstetricians and gynecologists, who were identified using the National Provider Identification database, because not all practicing ob-gyns received payments. These payments were analyzed with respect to 1) types of payments, 2) demographic attributes of health care providers receiving payments, and 3) comparisons between obstetrician and gynecologist subspecialties. Continuous data were compared using the Mann-Whitney test for variables that were not normally distributed and with the t test for variables that are normally distributed. RESULTS: A total of 517,077 nonresearch payments, totaling $79,965,244, were made to 23,292 ob-gyns. Physicians receiving payments were predominantly female, younger than 65 years old, allopathic physicians who graduated from U.S. medical schools in the late 1990s, and were board-certified subspecialists (P<.001 for all). Half of all ob-gyns received payments of varying amounts from drug manufacturers, device manufacturers, or both, with most of the payments for honoraria, faculty compensation, or consulting. Female pelvic medicine and reconstructive surgery physicians received the largest median dollar amount; maternal-fetal medicine physicians received the smallest. CONCLUSION: Obstetricians and gynecologists receive a substantial amount of payments from industry. Most of these payments were for honoraria, faculty compensation, or consulting and totaled less than $400 per health care provider. Although this total amount is less than typically received by surgical providers, including orthopedic surgeons who account for the highest compensated group in total and mean industry payments, the median payment value for obstetrics and gynecology subspecialists surpasses the median payment to orthopedic surgeons. These financial relationships warrant further exploration with future research.

Racial Differences in Information Needs During and After Cancer Treatment: a Nationwide, Longitudinal Survey by the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program.

Before treatment, cancer patients need information about side effects and prognosis, while after treatment they need information to transition to survivorship. Research documenting these needs is limited, especially among racial and ethnic minorities. This study evaluated cancer patients' needs according to race both before and after treatment. We compared white (n = 904) to black (n = 52) patients receiving treatment at 17 National Cancer Institute Community Oncology Research Program (NCORP) sites on their cancer-related concerns and need for information before and after cancer treatment. Two-sample t test and chi-squared analyses were used to assess group differences. Compared to white patients, black patients reported significantly higher concerns about diet (44.3 vs. 25.4 %,) and exercise (40.4 vs. 19.7 %,) during the course of treatment. Compared to whites, blacks also had significantly higher concern about treatment-related issues (white vs. black mean, 25.52 vs. 31.78), self-image issues (7.03 vs. 8.60), family-related issues (10.44 vs. 12.84), and financial concerns (6.42 vs. 8.90, all p < 0.05). Blacks, compared to whites, also had significantly greater post-treatment information needs regarding follow-up tests (8.17 vs. 9.44), stress management (4.12 vs. 4.89), and handling stigma after cancer treatment (4.21 vs. 4.89) [all p < 0.05]. Pre-treatment concerns and post-treatment information needs differed by race, with black patients reporting greater information needs and concerns. In clinical practice, tailored approaches may work particularly well in addressing the needs and concerns of black patients.

Oral curcumin for radiation dermatitis: a URCC NCORP study of 686 breast cancer patients.

PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancer patients. Patients took four 500-mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until 1 week post-RT. RESULTS: A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed-model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) = 0.044 (- 0.101, 0.188), p = 0.552). Fewer curcumin patients with RDS > 3.0 suggested a trend toward reduced severity (7.4 vs. 12.9%, p = 0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS: Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.

Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study.

Purpose Cancer-related cognitive impairment is an important problem for patients with breast cancer, yet its trajectory is not fully understood. Some previous cancer-related cognitive impairment research is limited by heterogeneous populations, small samples, lack of prechemotherapy and longitudinal assessments, use of normative data, and lack of generalizability. We addressed these limitations in a large prospective, longitudinal, nationwide study. Patients and Methods Patients with breast cancer from community oncology clinics and age-matched noncancer controls completed the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at prechemotherapy and postchemotherapy and at a 6-month follow-up as an a priori exploratory aim. Longitudinal models compared FACT-Cog scores between patients and controls at the three assessments and adjusted for age, education, race, menopausal status, and baseline reading ability, anxiety, and depressive symptoms. A minimal clinically important difference cutoff determined percentages of impairment over time. Results Of patients, 581 patients with breast cancer (mean age, 53 years; 48% anthracycline-based regimens) and 364 controls (mean age, 53 years) were assessed. Patients reported significantly greater cognitive difficulties on the FACT-Cog total score and four subscales from prechemotherapy to postchemotherapy compared with controls as well as from prechemotherapy to 6-month follow-up (all P < .001). Increased baseline anxiety, depression, and decreased cognitive reserve were significantly associated with lower FACT-Cog total scores. Treatment regimen, hormone, or radiation therapy was not significantly associated with FACT-Cog total scores in patients from postchemotherapy to 6-month follow-up. Patients were more likely to report a clinically significant decline in self-reported cognitive function than were controls from prechemotherapy to postchemotherapy (45.2% v 10.4%) and from prechemotherapy to 6-month follow-up (36.5% v 13.6%). Conclusion Patients with breast cancer who were treated in community oncology clinics report substantially more cognitive difficulties up to 6 months after treatment with chemotherapy than do age-matched noncancer controls.

Bundling of Reimbursement for Inferior Vena Cava Filter Placement Resulted in Significantly Decreased Utilization between 2012 and 2014.

BACKGROUND: On January 1, 2012, reimbursement for inferior vena cava filters (IVCFs) became bundled by the Centers for Medicare and Medicaid Services. This resulted in ICVF placement (CPT code 37191) now yielding 4.71 relative value units (RVUs), a decrease from 15.6 RVUs for placement and associated procedures (CPT codes 37620, 36010, 75825-26, 75940-26). Our hypothesis was that IVCF utilization would decrease in response to this change as other procedures had done once they had become bundled. METHODS: Including data from 2010 to 2011 (before bundling) and 2012 to 2014 (after bundling), we utilized 5% inpatient, outpatient, and carrier files of Medicare limited data sets and analyzed IVCF utilization before and after bundling across specialty types, controlling for total diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) (ICD-9 codes 453.xx and 415.xx, respectively) and placement location. RESULTS: In 2010 and 2011, the rates/10,000 DVT/PE diagnoses were 918 and 1,052, respectively (average 985). In 2012, 2013, and 2014, rates were 987, 877, and 605, respectively (average 823). Comparing each year individually, there is a significant difference (P < 0.0001) with 2012, 2013, and 2014 having lower rates of ICVF utilization. Comparing averages in the 2010-2011 and 2012-2014 groups, there is also a significant decrease in utilization after bundling (P < 0.0001). CONCLUSIONS: Following the bundling of reimbursement for IVCF placement, procedural utilization decreased significantly. More data from subsequent years will be needed to show if this decrease utilization continues to persist.

pH-responsive and enzymatically-responsive hydrogel microparticles for the oral delivery of therapeutic proteins: Effects of protein size, crosslinking density, and hydrogel degradation on protein delivery.

Two potential platform technologies for the oral delivery of protein therapeutics were synthesized and tested. pH-responsive poly(itaconic acid-co-N-vinyl-2-pyrrolidone) (P(IA-co-NVP)) hydrogel microparticles were tested in vitro with model proteins salmon calcitonin, urokinase, and rituximab to determine the effects of particle size, protein size, and crosslinking density on oral delivery capability. Particle size showed no significant effect on overall delivery potential but did improve percent release of encapsulated protein over the micro-scale particle size range studied. Protein size was shown to have a significant impact on the delivery capability of the P(IA-co-NVP) hydrogel. We show that when using P(IA-co-NVP) hydrogel microparticles with 3 mol% tetra(ethylene glycol) dimethacrylate crosslinker, a small polypeptide (salmon calcitonin) loads and releases up to 45 µg/mg hydrogel while the mid-sized protein urokinase and large monoclonal antibody rituximab load and release only 19 and 24 µg/mg hydrogel, respectively. We further demonstrate that crosslinking density offers a simple method for tuning hydrogel properties to variously sized proteins. Using 5 mol% TEGDMA crosslinker offers optimal performance for the small peptide, salmon calcitonin, whereas lower crosslinking density of 1 mol% offers optimal performance for the much larger protein rituximab. Finally, an enzymatically-degradable hydrogels of P(MAA-co-NVP) crosslinked with the peptide sequence MMRRRKK were synthesized and tested in simulated gastric and intestinal conditions. These hydrogels offer ideal loading and release behavior, showing no degradative release of encapsulated salmon calcitonin in gastric conditions while yielding rapid and complete release of encapsulated protein within 1h in intestinal conditions.

Hearing function in patients living with HIV/AIDS.

OBJECTIVES: During the earlier years of the HIV/AIDS epidemic, initial reports described sensorineural hearing loss in up to 49% of individuals with HIV/AIDS. During those years, patients commonly progressed to advanced stages of HIV disease and frequently had neurological complications. However, the abnormalities on pure-tone audiometry and brainstem-evoked responses outlined in small studies were not always consistently correlated with advanced stages of HIV/AIDS. Moreover, these studies could not exclude the confounding effect of concurrent opportunistic infections and syphilis. Additional reports also have indicated that some antiretroviral medications may be ototoxic; thus, it has been difficult to make conclusions regarding the cause of changes in hearing function in HIV-infected patients. More recently, accelerated aging has been suggested as a potential explanation for the disproportionate increase in complications of aging described in many HIV-infected patients; hence, accelerated aging-associated hearing loss may also be playing a role in these patients. DESIGN: We conducted a large cross-sectional analysis of hearing function in over 300 patients with HIV-1 infection and in 137 HIV-uninfected controls. HIV-infected participants and HIV-uninfected controls underwent a 2-hr battery of hearing tests including the Hearing Handicap Inventory, standard audiometric pure-tone air and bone conduction testing, tympanometric testing, and speech reception and discrimination testing. RESULTS: Three-way analysis of variance (ANOVA) and logistic regression analysis of 278 eligible HIV-infected subjects stratified by disease stage in early HIV disease (n = 127) and late HIV disease (n = 148) and 120 eligible HIV-uninfected controls revealed no statistically significant differences among the three study groups in either overall 4-frequency pure-tone average (4-PTA) or hearing loss prevalence in either ear. Three-way ANOVA showed significant differences in word recognition scores in the right ear among groups, a significant group effect on tympanogram static admittance in both ears and a significant group effect on tympanic gradient in the right ear. There was significantly larger admittance and gradient in controls as compared to the HIV-infected group at late stage of disease. Hearing loss in the HIV-infected groups was associated with increased age and was similar to that described in the literature for the general population. Three-way ANOVA analysis also indicated significantly greater pure-tone thresholds (worse hearing) at low frequencies in HIV patients in the late stage of disease compared with HIV-uninfected controls. This difference was also found by semi-parametric mixed effects models. CONCLUSIONS: Despite reports of "premature" or "accelerated" aging in HIV-infected subjects, we found no evidence of hearing loss occurring at an earlier age in HIV-infected patients compared to HIV-uninfected controls. Similar to what is described in the general population, the probability of hearing loss increased with age in the HIV-infected subjects and was more common in patients over 60 years of age. Interestingly, HIV-infected subjects had worse hearing at lower frequencies and have significant differences in tympanometry compared to HIV-uninfected controls; these findings deserve further study.

Cohort study of smoke-free homes in economically disadvantaged communities in the Dominican Republic.

OBJECTIVE: To analyze household smoking-ban prevalence over time and predictors among communities in the Dominican Republic, historically a significant tobacco-growing country with few tobacco control regulations. METHODS: Baseline (2004) and follow-up surveillance surveys (2006, 2007) (each n > 1 000 randomly selected households) conducted in six economically disadvantaged communities (three tobacco-growing and two each urban, peri-urban, and rural) assessed household members' demographics, health status, and household characteristics, including smoking restrictions. RESULTS: Between 2004 and 2007, household smoking-ban prevalence increased in all communities, with overall rates increasing from 23.9% (2004) to 45.3% (2007). Households with smokers adopted smoking bans at lower rates (6%-17%) versus those without smokers (which had an adoption rate of 35%-58%). Logistic regression models demonstrated that the associations between allowing smoking in households with no members who smoked and being located in a tobacco-growing community, being a Catholic household, and having a member with a cardiovascular problem were statistically significant. The association between having a child under age 5 or a member with a respiratory condition and prohibiting smoking in the home was not statistically significant. CONCLUSIONS: Prevalence of households banning smoking increased in all communities but remained well below rates in industrialized countries. For low- and middle-income countries or those in early stages of tobacco control, basic awareness-raising measures (including surveillance activities) may lead to statistically significant increases in household smoking-ban adoption, particularly among households with no smokers. An increase in household smoking-ban prevalence may result in changes in community norms that can lead to a further increase in the adoption of smoking bans. Having household members who smoke and being in a tobacco-growing community may mitigate the establishment of household bans. Increasing individuals' knowledge about the far-reaching health effects of secondhand smoke exposure on children and nonsmoking adults (healthy or unhealthy) may help overcome these obstacles.

Physical activity as a coping strategy for smoking cessation in mid-life and older adults.

Smoking prevalence for those ages 45-65 is higher than the national average and the number of mid-life and older smokers is expected to increase as baby boomers age. Cessation, even after age 65, confers health benefits. Both physiologic and psychological mechanisms support use of physical activity (PA) as a coping tool for quitting and improving health. This study focused on use of PA for coping with urges to smoke, factors associated with use, and whether use of PA was associated with abstinence at 12 months for 799 smokers ages 50 and older. Only 11.6% used PA for coping, with walking the most common PA. Females were more likely to use PA relative to males. Though in the predicted direction, use of PA was not significantly associated with 12-month abstinence. Male gender and higher baseline self-efficacy to quit were associated with 12 month abstinence. Encouraging use of PA during smoking cessation does not impede quitting and may improve health outcomes. Further research on whether PA increases abstinence with a larger sample of mid-life and older adults is indicated.