A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation.

PURPOSE: This study investigates the performance of a cardiac-based seizure detection algorithm (CBSDA) that automatically triggers VNS (NCT01325623). METHODS: Thirty-one patients with drug resistant epilepsy were evaluated in an epilepsy monitoring unit (EMU) to assess algorithm performance and near-term clinical benefit. Long-term efficacy and safety were evaluated with combined open and closed-loop VNS. RESULTS: Sixty-six seizures (n=16 patients) were available from the EMU for analysis. In 37 seizures (n=14 patients) a ≥ 20% heart rate increase was found and 11 (n=5 patients) were associated with ictal tachycardia (iTC, 55% or 35 bpm heart rate increase, minimum of 100 bpm). Multiple CBSDA settings achieved a sensitivity of ≥ 80%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within ± 2 min of seizure onset. In 10/17 of these seizures, where triggered VNS overlapped with ongoing seizure activity, seizure activity stopped during stimulation. Physician-scored seizure severity (NHS3-scale) showed significant improvement for complex partial seizures (CPS) at EMU discharge and through 12 months (p<0.05). Patient-scored seizure severity (total SSQ score) showed significant improvement at 3 and 6 months. Quality of life (total QOLIE-31-P score) showed significant improvement at 12 months. The responder rate (≥ 50% reduction in seizure frequency) at 12 months was 29.6% (n=8/27). Safety profiles were comparable to prior VNS trials. CONCLUSIONS: The investigated CBSDA has a high sensitivity and an acceptable specificity for triggering VNS. Despite the moderate effects on seizure frequency, combined open- and closed-loop VNS may provide valuable improvements in seizure severity and QOL in refractory epilepsy patients.

Ictal tachycardia: the head-heart connection.

Epileptic seizures can lead to changes in autonomic function affecting the sympathetic, parasympathetic, and enteric nervous systems. Changes in cardiac signals are potential biomarkers that may provide an extra-cerebral indicator of ictal onset in some patients. Heart rate can be measured easily when compared to other biomarkers that are commonly associated with seizures (e.g., long-term EEG), and therefore it has become an interesting parameter to explore for detecting seizures. Understanding the prevalence and magnitude of heart rate changes associated with seizures, as well as the timing of such changes relative to seizure onset, is fundamental to the development and use of cardiac based algorithms for seizure detection. We reviewed 34 articles that reported the prevalence of ictal tachycardia in patients with epilepsy. Scientific literature supports the occurrence of significant increases in heart rate associated with ictal events in a large proportion of patients with epilepsy (82%) using concurrent electroencephalogram (EEG) and electrocardiogram (ECG). The average percentage of seizures associated with significant heart rate changes was similar for generalized (64%) and partial onset seizures (71%). Intra-individual variability was noted in several articles, with the majority of studies reporting significant increase in heart rate during seizures originating from the temporal lobe. Accurate detection of seizures is likely to require an adjustable threshold given the variability in the magnitude of heart rate changes associated with seizures within and across patients.

Racial/ethnic disparities in survival among men diagnosed with prostate cancer in Texas.

BACKGROUND: To the authors' knowledge, few studies to date have examined racial differences in prostate cancer survival while controlling for socioeconomic status (SES). No such studies have examined this association in Texas, a large state with significant ethnic and racial diversity. The objective of this analysis was to determine whether racial disparities in survival for men diagnosed with prostate cancer in Texas from 1995 through 2002 remained after adjusting for SES, rural residence, and stage of disease. METHODS: A cohort of 87,449 men who were diagnosed with prostate cancer was identified from the Texas Cancer Registry. The SES measure was based on census tract data reflecting median household income, median home value, and percentages of men living below poverty, with a college education, and with a management or professional occupation. The 5-year survival rates were calculated using the Kaplan-Meier method and Cox proportional hazard modeling was used to estimate hazard ratios (HRs) for race and all-cause and disease-specific mortality. RESULTS: After adjusting for SES, age, stage of disease, tumor grade, year of diagnosis, and rural residence, both black and Hispanic men were more likely (adjusted HR [aHR], 1.70 [95% confidence interval (95% CI), 1.58-1.83] and aHR, 1.11 [95% CI, 1.02-1.20], respectively) to die of prostate cancer compared with white men. The pattern of survival disadvantage for black men held for those diagnosed with localized disease and advanced disease, and for those with an unknown stage of disease at diagnosis. CONCLUSIONS: Substantial racial disparities in prostate cancer survival were found for men in Texas. Future studies should incorporate treatment data as well as comorbid conditions because this information may explain noted survival disparities.

HPV vaccine acceptance among Latina mothers by HPV status.

OBJECTIVE: We investigated whether Latina mothers who were and were not human papillomavirus (HPV) positive differed in their knowledge and acceptance of the HPV vaccine for their children. METHODS: We conducted a cross-sectional survey among women aged 18-64 years between April 2007 and April 2008. Data collectors conducted in-person interviews in community clinics with 215 HPV-negative women and 190 HPV-positive women (with respective response rates of 64% and 84%). Most (83%) HPV-positive women were recruited at dysplasia clinics. Although no HPV-negative women were recruited at dysplasia clinics, they were recruited at other low-income public and private clinics. RESULTS: After adjustment for age, marital status, and health insurance, women who were HPV positive were more likely than HPV-negative women to have heard about the HPV vaccine, to indicate they would have their daughters and sons vaccinated against cervical cancer even if they had to pay themselves, and to be in favor of the proposed Texas law requiring girls to receive the HPV vaccine before entry into sixth grade but less likely to be in favor of girls receiving the vaccine at age > or =13. CONCLUSIONS: Our findings indicate that >90% of Latinas living on the Texas-Mexico border find the HPV vaccine acceptable for their own daughters and sons.

Ethnic disparities in cervical cancer survival among Texas women.

OBJECTIVE: The aim of this work was to determine whether minority women are more likely to die of cervical cancer. A population-based cohort study was performed using Texas Cancer Registry (TCR) data from 1998 to 2002. METHODS: A total of 5,166 women with cervical cancer were identified during 1998-2002 through the TCR. Measures of socioeconomic status (SES) and urbanization were created using census block group-level data. Multilevel logistic regression was used to calculate the odds of dying from cervical cancer by race, and Cox proportional hazards modeling was used for cervical cancer-specific survival analysis. RESULTS: After adjusting for age, SES, urbanization, stage, cell type, and treatment, Hispanic women were significantly less likely than non-Hispanic White women to die from cervical cancer (adjusted hazard ratio [aHR] = 0.69; 95% CI [confidence interval] = 0.59-0.80), whereas Black women were more likely to die (aHR = 1.26; 95% CI = 1.06-1.50). Black and Hispanic women were more likely to be diagnosed at a later stage than White women. Black women were significantly less likely to receive surgery among those diagnosed with localized disease (p = 0.001) relative to both White and Hispanic women. CONCLUSIONS: Relative to non-Hispanic White women, Black women were more likely to die of cervical cancer while Hispanic women were less likely to die; these survival differences were not explained by SES, urbanization, age, cell type, stage at diagnosis, or treatment.

Ethnic disparities in cervical cancer survival among Medicare eligible women in a multiethnic population.

UNLABELLED: To determine predictors of cervical cancer survival by socioeconomic status (SES), urbanization, race/ethnicity, comorbid conditions, and treatment among elderly Medicare-eligible women whose conditions were diagnosed with cervical cancer in a multiethnic population. METHODS: : A total of 538 women with cervical cancer aged 65 years or older were identified from 1999 to 2001 from the Texas Cancer Registry and were linked with the state Medicare data and Texas Vital Records to determine survival times. All women had similar access to care through Medicare fee-for-services insurance. A composite measure of SES was created using census tract-level data as was urbanization. Treatment and comorbid conditions were available from the Medicare data. Cox proportional hazards modeling was used for all-cause and cervical cancer-specific survival analysis. RESULTS: : Increased age (P < 0.0001) and advanced tumor stage (P < 0.0001) were associated with poorer all-cause and cervical cancer-specific survival. Having a comorbid condition was associated with all-cause survival (P < 0.01) but not cervical cancer-specific mortality. After adjusting for confounders, women receiving some form of treatment were almost half as likely to die with cervical cancer (adjusted hazard ratio = 0.68; 95% confidence interval, 0.52-0.89). After adjustment for all confounders, Hispanic women consistently had lower all-cause and cervical cancer-specific mortality rates relative to non-Hispanic white and non-Hispanic black women. CONCLUSIONS: : Among women with similar health care coverage, Hispanic women had consistently lower all-cause and cervical cancer-specific mortality rates than other older women whose conditions were diagnosed with this disease in Texas. The presence of comorbid conditions and treatment were important predictors of survival, yet these factors do not explain the survival advantage for Hispanic women.

Smoking and survival among Kentucky women diagnosed with invasive cervical cancer: 1995-2005.

OBJECTIVES: To determine whether smokers with cervical cancer were more likely to die from cervical cancer compared with non smokers after adjusting for confounding factors. METHODS: A population-based survival analysis was conducted among 2661 women diagnosed with invasive cervical cancer and reported to the Kentucky Cancer Registry from 1995-2005 and linked with state vital records and the National Death Index through 12/31/2005. A standard Kaplan - Meier approach was used in this survival analysis and Cox Proportional Hazards modeling was used to estimate adjusted hazard [aHR] ratios and 95% confidence intervals [CI] for smoking and survival for all cause and cervical cancer specific cause of death. RESULTS: Almost half of women diagnosed with cervical cancer (48.6%) were known to be current smokers based the medical record review and reporting to KCR. For another 19.4% no tobacco status was documented (missing) and 32.1% were known non smokers. After adjustment for age and stage at diagnosis, cell type, rural residence, race, insurance coverage, and treatment received, current smoker were 35% more likely to die of any cause (aHR=1.35; 95% CI=1.17-1.56) and 21% more likely to die of cervical cancer (aHR=1.21; 95% CI=1.01-1.46) compared with known non smoking cases. CONCLUSION: These data strongly suggest that smoking reduces cervical cancer survival.

Adherence to recommendations for follow-up to abnormal Pap tests.

OBJECTIVE: To evaluate whether timely adherence rates differ by race among women with abnormal Pap tests participating in a cost-free or reduced-cost program. METHODS: Eligible subjects included women aged 47-64 years who received a referral for follow-up care after an abnormal Pap test from 1999 to 2002 in South Carolina (n=330). Adherence was measured as days to receipt of follow-up care after an abnormal Pap test. Cox proportional hazards modeling was used to estimate risk factors associated with time to adherence within 60 and 365 days by race. RESULTS: African-American and non-Hispanic white women had similar adherence to follow-up. Among white women, those with high-grade lesions were less likely to adhere in a timely manner relative to those with low-grade lesions (hazard ratio 0.6, 95% confidence interval [CI] 0.4-1.0). For African-American women, rural residence (hazard ratio: 0.5, 95% CI 0.2-0.9) and history of abnormal Pap tests (hazard ratio 0.6, 95% CI 0.3-1.0) were associated with decreased adherence, whereas less education (hazard ratio 2.3, 95% CI 1.3-3.9) was associated with increased adherence. CONCLUSION: Adherence rates do not differ by race. However, risk factors for adherence within race are variable. Interventions tailored to the differential needs of racial and ethnic groups may prove effective toward increasing timely adherence rates. LEVEL OF EVIDENCE: II.

Understanding barriers for adherence to follow-up care for abnormal pap tests.

OBJECTIVE: Approximately 4000 women annually will die from preventable and treatable cervical cancer. Failure to adhere to follow-up recommendations after an abnormal Pap test can lead to development of cervical cancer. This paper summarizes the body of literature on adherence to follow-up after an abnormal Pap test in order to facilitate development of interventions to decrease morbidity and mortality due to cervical cancer. METHODS: We conducted a comprehensive search of published literature addressing risk factors for adherence or interventions to improve adherence following an abnormal Pap test as the outcome. We included peer-reviewed original research conducted in the United States from 1990 to 2005. RESULTS: Fourteen analytical and twelve experimental studies that met our criteria were reviewed. Lesion severity and health beliefs were consistently associated with adherence rates. Communication interventions, including telephone reminders, counseling, and educational sessions, increased follow-up compliance across intervention studies. Inconsistent evidence for associations among race, income, and age were found. CONCLUSIONS: Further research is needed to reinforce current studies addressing health beliefs and social support. Interventions that focus on the interplay among psychological, educational, and communication barriers are necessary. These interventions should be adapted and applied across various racial/ethnic and socioeconomic groups to reach all women with a high-risk profile for invasive cervical cancer.

What predicts adherence to follow-up recommendations for abnormal Pap tests among older women?

OBJECTIVE: To address socio-demographic factors associated with adherence to follow-up recommendations in a high-risk population of women referred for follow-up care after an abnormal Pap test. METHODS: 486 women aged 46-64 served by BCCEDP in two southeastern states between 1999-2002 and referred for follow-up care after an abnormal Pap test were the sampling frame for this cross-sectional study; 204 women completed a phone-based interview in 2004. Cox proportional hazards modeling was used to determine the association of various risk factors with time to adherence. RESULTS: Among those completing the phone interview (interview rate=61.4%) the mean age was 53.3 years, 64.7% were African-American women, 81.9% had low-grade cervical lesions, and all were either uninsured or under insured. Over 95% received follow-up care for an abnormal Pap test within 365 days of referral. When the BCCEDP criteria of follow-up within 60 days were applied, 52.9% were adherent. Rates of self-reported and program documented adherence differed significantly by state. After adjusting for state of residence, women who reported having symptoms of a chronic disease were more likely to be adherent within 365 days (aHR=1.42; 95% CI=1.00, 2.04). Neither age, race, lesion severity, education, number of dependent adults or children, self-perceived physical health, nor smoking status was associated with time to adherence. CONCLUSIONS: Findings suggest that institutional factors may be more important than individual factors in predicting time to adherence for an abnormal Pap test.

Cervical cancer survival by socioeconomic status, race/ethnicity, and place of residence in Texas, 1995-2001.

OBJECTIVE: The current study explored whether socioeconomic status (SES), race/ethnicity, and rural residence may be linked to poorer cervical cancer survival by stage at diagnosis. METHODS: Data from 7,237 cervical cancer cases reported to the Texas Cancer Registry from 1995-2001 were used to address the association by stage at diagnosis and cause of death. Zip code-level census data were used to classify residence and to develop a composite variable for SES. Multilevel Cox proportional hazards modeling was used to estimate hazard ratios (HR) and 95% confidence intervals (CI). RESULTS: Late stage at diagnosis was a strong predictor of cervical cancer mortality (HR = 6.2, 95% CI 5.5-7.2). SES and race/ethnicity were independently associated with stage at diagnosis. Women residing in areas with lower SES had significantly shorter survival times when diagnosed at an early stage (HR = 3.0, 95% CI 2.1-4.3). Hispanic women had a lower probability of dying from cervical cancer during the follow-up period (HR = 0.7, 95% CI 0.6- 0.8) after adjusting for confounders. The association between lower SES and poorer survival was consistent across all racial/ethnic groups, suggesting the effect of SES may be more important than race. CONCLUSIONS: SES and race/ethnicity were independently associated with poorer cervical cancer survival in this large Texas sample. Further research is needed to investigate the role of optimal treatment and comorbid conditions in the association between SES and cervical cancer survival.

Social and mental health needs assessment of Katrina evacuees.

Hurricane Katrina made landfall along the Gulf Coast as a Category 3 storm on August 29, 2005. Many residents were evacuated to neighboring cities owing to massive destruction. Working with the City of Houston Health Department, researchers conducted a medical and psychological needs assessment of 124 Hurricane Katrina evacuees in Houston shelters from September 4-12, 2005. Among those willing to talk about their experiences, 41% were afraid they would die, 16% saw someone close to them injured or die, 17% saw violence, and 6% directly experienced physical violence. When using a version of the Impact of Stress Experiences scale, the majority of evacuees scored as experiencing moderate (38.6%) to severe (23.9%) post-traumatic stress disorder (PTSD) symptoms. These data suggest that in addition to challenges in finding loved ones, housing, and jobs, many Katrina survivors have experienced significant psychological trauma that may lead to future PTSD.

Socioeconomic status and cervical cancer survival among older women: findings from the SEER-Medicare linked data cohorts.

OBJECTIVES: Tumor stage, age, and cell type are well-characterized predictors for cervical cancer survival; socioeconomic factors may also play an important role. The purpose of this study is to estimate cervical cancer survival by socioeconomic indicators and race/ethnicity among elderly women diagnosed with cervical cancer. METHODS: We studied 1251 women with cervical cancer aged 65 or older, identified between 1992 and 1999 from the Surveillance, Epidemiology, and End Results [SEER]-Medicare linked data. All women had similar access to care through Medicare fee-for-services insurance. A composite measure of socioeconomic status was created using census tract level data for poverty, education, and income. Cox proportional hazard modeling was used for all-cause and cervical cancer-specific survival analysis. RESULTS: Increased age (P < 0.0001) and advanced tumor stage (<0.0001) were associated with poorer all-cause and cervical cancer-specific survival. After adjustment for age, stage, and treatment, increased co-morbidity scores and having non-squamous cervical cancer were associated with poorer all-cause survival (P < 0.001). After adjusting for confounders, women receiving hysterectomy vs. no surgery or any treatment had significantly better all-cause and cervical cancer-specific survival. Socioeconomic factors were not associated with either all-cause (P for trend = 0.79) or cervical cancer-specific (P for trend = 0.81) survival. No racial/ethnic differences in all-cause or cervical cancer-specific survival were observed after adjusting for socioeconomic factors. CONCLUSION: Among women with similar access to care, neither minority race/ethnicity nor poorer socioeconomic status were associated with poorer survival in this large sample of older women diagnosed with invasive cervical cancer. Presence of co-morbid conditions and treatment were important predictors of cervical cancer survival.