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Heart transplant-related stressors and coping are related to poor outcomes early after transplant. The purposes of our study were to (1) identify the most frequent and bothersome stressors and most used and effective coping strategies, and (2) compare the most frequent and bothersome stresses and most used and effective coping styles between patients at 5 and 10 years after heart transplantation. We also examined differences in coping styles by patient characteristics, and factors associated with frequency and intensity of stress at both 5 and 10 years after heart transplantation.
This report is a secondary analysis of data from a prospective, multi-site study of quality of life outcomes. Data are from 199 and 98 patients at 5 and 10 years after transplant, respectively. Patients completed the Heart Transplant Stressor Scale and Jalowiec Coping Scale. Statistical analyses included frequencies, measures of central tendency, t-tests, Chi-square and generalized linear models.
At 5 and 10 years after heart transplantation, the most bothersome stressors were regarding work, school, and financial issues. Patients who were 10 years post transplant reported less stress, similar stress intensity, and less use and perceived effectiveness of negative coping than patients who were 5 years post transplant. Long-term after transplant, demographic characteristics, psychological problems, negative coping, and clinical factors were related to stress frequency and/or intensity.
Heart transplant-related stress occurs long-term after surgery. Types of transplant-related stress and factors related to stress confirm the importance of ongoing psychological and clinical support after heart transplantation.
PMCID: PMC3602911  PMID: 23498164
2.  The Relationship of Sociodemographic Factors and Satisfaction with Social Support at 5 and 10 years after Heart Transplantation 
Clinical transplantation  2012;27(2):267-273.
Despite the fact that social support has been found to be important to cardiovascular health, there is a paucity of information regarding the relationship between social support and outcomes long-term after heart transplantation (HT). The purposes of this study were to examine demographic and psychosocial characteristics and their relationship to social support after HT, and identify if sociodemographic variables are predictors of satisfaction with social support post HT.
Data were collected from 555 HT patients (pts) (78% male, 88% white, mean age=53.8 years at time of transplant) at 4 U.S. medical centers using the following instruments: Social Support Index, QOL Index, HT Stressor Scale, Jalowiec Coping Scale, Sickness Impact Profile, Cardiac Depression Scale, and medical records review Statistical analyses included t-tests, correlations, and linear and multivariable regression.
There were no associations between education, and ethnicity and perception of social support at 5 and 10 yrs after HT. Married and older pts reported higher satisfaction with social support after HT. Being married and higher education were predictors of better overall satisfaction with social support at 10 years post heart transplantation.
Knowledge of relationships among sociodemographic factors and social support may assist clinicians to address social support needs and resources long-term after HT.
PMCID: PMC3622832  PMID: 23278755
3.  Burden of menstrual symptoms in Japanese women – an analysis of medical care-seeking behavior from a survey-based study 
Menstrual symptoms are associated with various health problems in women of reproductive age, and this may impact their quality of life. Despite this, Japanese women are likely to hesitate seeking a specialist’s medical help for their menstrual symptoms.
To study subject parameters including symptom severity, gynecological disorders, and treatments in medical care-seeking women (outpatient) and women opting for self-care (nonvisit), to identify reasons why Japanese women do not see a gynecologist, and to document the benefit of gynecologist visits by assessing the impact on women’s daily lives.
Two online surveys were conducted among women aged 15–49 years. Sampling was structured to approximate the age and geographic distribution in Japan. Results of the first survey and part of the second survey on the overall current burden of menstrual symptoms are reported in a separate publication. Further outcomes from the second survey reported in this paper included data from the outpatient (n=274) and nonvisit (n=500) groups on symptom severity, gynecological disorders, medical treatment use, reasons for not seeking medical care, and the improvement of daily life.
The outpatient group tended to have greater symptom severity compared to the nonvisit group. Uterine fibroids, dysmenorrhea, endometriosis, and premenstrual syndrome were the most commonly self-reported diagnoses, and oral contraceptives were frequently prescribed at gynecologist visits. Nonvisit group subjects felt that gynecologist consultations were unnecessary or felt resistant to them. Daily life was significantly improved after medical treatment from a gynecologist visit with associated economic savings, whilst the nonvisit group had no change after taking over-the-counter drugs to relieve their menstrual symptoms.
The present study results indicate that Japanese women who were suffering from menstrual symptoms could benefit from visiting a gynecologist for easing their symptoms, hence improving their daily life.
PMCID: PMC3869918  PMID: 24368891
menstrual symptoms; burden; outpatient; care-seeking; MDQ score; patient reported outcome
4.  Relationship among Trust in Physicians, Demographics, and End-of-life Treatment Decisions Made by African American Dementia Caregivers 
A pilot study was conducted in an urban African American community to explore the relationship between trust in physicians, demographics and end-of-life treatment decisions made by African American caregivers of family members with dementia: namely, cardiopulmonary resuscitation, mechanical ventilation and tube feeding.
In a cross-sectional design, standard measures were administered to a convenience sample of 68 African American caregivers of family members with dementia. Univariate and multivariate analyses were used to explore associations among the variables.
Those with more education exhibited higher (p = 0.035) trust in physicians than less educated individuals. Caregivers who were more trusting of their physicians were more likely to use mechanical ventilation (p = 0.0005) than were less trusting caregivers. Conversely, more trusting caregivers were less likely to use tube feeding (p = 0.022).
Our findings suggest relationships exist among trust in physicians, demographics and end-of-life treatment decisions. Thus, health care providers should consider African American caregivers’ perceived trust in physicians when counseling about dementia and end-of-life treatment choices.
PMCID: PMC3864045  PMID: 24353477
Trust in physicians; African American; dementia; cardiopulmonary resuscitation; mechanical ventilation; tube feeding
5.  NUTORC—a transdisciplinary health services and outcomes research team in transplantation 
The field of solid organ transplantation has historically concentrated research efforts on basic science and translational studies. However, there has been increasing interest in health services and outcomes research. The aim was to build an effective and sustainable, inter- and transdisciplinary health services and outcomes research team (NUTORC), that leveraged institutional strengths in social science, engineering, and management disciplines, coupled with an international recognized transplant program. In 2008, leading methodological experts across the university were identified and intramural funding was obtained for the NUTORC initiative. Inter- and transdisciplinary collaborative teams were created across departments and schools within the university. Within 3 years, NUTORC became fiscally sustainable, yielding more than tenfold return of the initial investment. Academic productivity included funding for 39 grants, publication of 60 manuscripts, and 166 national presentations. Sustainable educational opportunities for students were created. Inter- and transdisciplinary health services and outcomes research in transplant can be innovative and sustainable.
PMCID: PMC3647618  PMID: 23667403
Transdisciplinary research teams; Health Services and Outcomes Research; Educational opportunities; Academic productivity; Sustainable research efforts
6.  Maternal and Umbilical Artery Cortisol at Birth: Relationships With Epidural Analgesia and Newborn Alertness 
Biological research for nursing  2011;14(3):10.1177/1099800411413460.
Newborn alertness soon after birth facilitates mother–infant interaction and may be related to umbilical cortisol levels. Yet, little is known about whether epidural analgesia influences umbilical cortisol at birth.
The aims of this study were to explore relationships between exposure to epidural analgesia and maternal and umbilical cortisol; maternal and umbilical cortisol levels at birth; and umbilical cortisol and infant alertness after birth.
Forty women were self-selected to unmedicated or epidural labors in this pilot study. Maternal saliva and infant umbilical artery (UA) plasma at birth were enzyme immunoassayed for cortisol. Infant alertness was assessed nearly 1 hr after birth.
Maternal cortisol was higher in the unmedicated versus epidural group (p = .003). Umbilical cortisol was not related to epidural analgesia exposure but was related to duration of labor (higher cortisol with longer labors; p = .026). Maternal cortisol level explained 55% of the variance in umbilical cortisol in the unmedicated group (p = .002), but there was no significant shared variance in the epidural sample (p = .776). There was a positive correlation (r2 = .17, p = .008) between umbilical cortisol and infant alertness. Latina infants demonstrated a higher frequency of alertness than Black infants. In multivariate analysis, umbilical cortisol (p = .049) and race/ethnicity (p = .024) remained significant predictors of infant alertness.
Our findings indicate that higher umbilical cortisol is related to greater infant alertness soon after birth. While epidural analgesia did not directly relate to infant cortisol, other factors contributed to higher umbilical cortisol.
PMCID: PMC3817017  PMID: 21719528
cortisol; alertness; birth; epidural; maternal; infant
7.  Assessing quality of life in the treatment of patients with age-related macular degeneration: clinical research findings and recommendations for clinical practice 
The importance of incorporating quality-of-life (QoL) assessments into medical practice is growing as health care practice shifts from a “disease-based” to a “patient-centered” model. The prevalence of age-related macular degeneration (AMD) is increasing in today’s aging population. The purpose of this paper is: (1) to discuss, by reviewing the current literature, the impact of AMD on patients’ QoL and the utility of QoL assessments in evaluating the impact of AMD and its treatment; and (2) to make a recommendation for incorporating QoL into clinical practice.
We conducted a PubMed and an open Internet search to identify publications on the measurement of QoL in AMD, as well as the impact of AMD and the effect of treatment on QoL. A total of 28 articles were selected.
AMD has been found to cause a severity-dependent decrement in QoL that is comparable to systemic diseases such as cancer, ischemic heart disease, and stroke. QoL impairment manifests as greater social dependence, difficulty with daily living, higher rates of clinical depression, increased risk of falls, premature admission to nursing homes, and suicide. The National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) is the most widely used eye disease-specific QoL instrument in AMD. It has been shown to correlate significantly with visual acuity (VA). QoL reflects aspects of AMD including psychological well-being, functional capacity, and the ability to perform patients’ valued activities, which are not captured by a single, numerical VA score.
The literature shows that the adverse impact of AMD on QoL is comparable to serious systemic disease. Eye disease-specific instruments for measuring QoL, such as the NEI VFQ-25, have shown a significant correlation of QoL decrement with measures of disease severity, as well as significant QoL improvement with treatment. The NEI VFQ-25 and other validated instruments provide a wide-ranging assessment of vision-related functioning that is important to patients and complementary to VA measurement. We strongly recommend the incorporation of QoL assessment into routine clinical practice.
PMCID: PMC3702546  PMID: 23836961
wet age-related macular degeneration; quality of life assessment; patient-reported outcome; clinical practice; review; NEI VFQ-25
8.  Pediatric Nurses’ Beliefs and Pain Management Practices: An Intervention Pilot 
We evaluated feasibility of the Internet-based Relieve Children's Pain (RCP) protocol to improve nurses’ management of children's pain. RCP is an interactive, content-focused, and Kolb's Experiential Learning Theory-based intervention. Using a one-group, pre/posttest design, we evaluated feasibility of RCP and pre/post difference in scores for nurses’ beliefs, and simulated and actual pain management practices. Twenty-four RNs completed an Internet-based Pain Beliefs and Practices Questionnaire (PBPQ, alpha=.83) before and after they completed the RCP and an Acceptability Scale afterward. Mean total PBPQ scores significantly improved from pre-to-posttest as did simulated practice scores. After RCP in actual hospital practice, nurses administered significantly more ibuprofen and keterolac and children's pain intensity significantly decreased. Findings showed strong evidence for the feasibility of RCP and study procedures and significant improvement in nurses’ beliefs and pain management practices. The 2-hour RCP program is promising and warrants replication with an attention control group and a larger sample.
PMCID: PMC3670117  PMID: 21172923
Children; pain; nursing; pain management; intervention
9.  The Comparative Effectiveness of Donation after Cardiac Death versus Donation after Brain Death Liver Transplantation: Recognizing Who Can Benefit 
Liver Transplantation  2012;18(6):630-640.
Due to organ scarcity and wait-list mortality, transplantation of donation after cardiac death (DCD) livers has increased. However, the group of patients benefiting from DCD liver transplantation is unknown. We studied the comparative effectiveness of DCD versus donation after brain death (DBD) liver transplantation.
A Markov model was constructed to compare undergoing DCD transplantation with remaining on the wait-list until death or DBD liver transplantation. Differences in life years, quality-adjusted life years (QALYs), and costs according to candidate Model for End-Stage Liver Disease (MELD) score were considered. A separate model for hepatocellular carcinoma (HCC) patients with and without MELD exception points was constructed.
For patients with a MELD score <15, DCD transplantation resulted in greater costs and reduced effectiveness. Patients with a MELD score of 15 to 20 experienced an improvement in effectiveness (0.07 QALYs) with DCD liver transplantation, but the incremental cost-effectiveness ratio (ICER) was >$2,000,000/QALY. Patients with MELD scores of 21 to 30 (0.25 QALYs) and >30 (0.83 QALYs) also benefited from DCD transplantation with ICERs of $478,222/QALY and $120,144/QALY, respectively. Sensitivity analyses demonstrated stable results for MELD scores <15 and >20, but the preferred strategy for the MELD 15 to 20 category was uncertain. DCD transplantation was associated with increased costs and reduced survival for HCC patients with exception points but led to improved survival (0.26 QALYs) at a cost of $392,067/QALY for patients without exception points.
In conclusion, DCD liver transplantation results in inferior survival for patients with a MELD score <15 and HCC patients receiving MELD exception points, but provides a survival benefit to patients with a MELD score >20 and to HCC patients without MELD exception points.
PMCID: PMC3365831  PMID: 22645057
cost-effectiveness; quality-adjusted life-years; regional variation; biliary complications
10.  Burden of comorbidities among Japanese patients with atrial fibrillation: a case study of dyspepsia 
The aim of this study was to investigate the link between atrial fibrillation (AF) and dyspepsia, as well as the contribution of dyspepsia to the overall burden of AF.
The 2008, 2009, and 2010 Japan National Health and Wellness Survey (NHWS) datasets were used in this study. The NHWS is an Internet-based survey administered to the adult population in Japan using a random stratified sampling framework to ensure demographic representativeness. The presence of dyspepsia was compared between those with and without AF. Among those with AF, the effect of dyspepsia on health status, work productivity, and activity impairment was examined, along with health care resource use using multivariable regression modeling and controlling for baseline differences.
Among patients with AF (n = 565), the three most commonly reported comorbidities were hypertension (38.76%), dyspepsia (37.35%), and overactive bladder (28.72%). Patients with AF had 48.59% greater odds of reporting dyspepsia than those without AF (P < 0.05). Patients with dyspepsia used more AF medications (2.05 versus 1.54) and had been diagnosed more recently (9.97 versus 10.58 years). Dyspepsia was associated with significantly worse physical health status (P < 0.05) and significantly more absenteeism, overall work impairment, activity impairment, physician visits, and emergency room visits (all P < 0.05).
Patients with AF in Japan experience a number of comorbidities, with dyspepsia being the most common noncardiovascular comorbidity. Given the prevalence and additional burden of this comorbidity across both humanistic and economic outcomes, the management of dyspepsia among patients with AF should be an area of greater focus.
PMCID: PMC3662464  PMID: 23717048
atrial fibrillation; dyspepsia; health status; work productivity; health care resource use
11.  Extrahepatic metastases occur in a minority of hepatocellular carcinoma patients treated by locoregional therapies: Analyzing patterns of progression in 285 patients 
Hepatology (Baltimore, Md.)  2012;55(5):1432-1442.
While most cancers are considered to be predominantly systemic processes, this may not hold true for hepatocellular carcinoma (HCC). The literature regarding patterns of progression of HCC (local versus systemic) has been relatively sparse. Our objectives were to: 1) analyze patterns of progression in HCC patients presenting with intrahepatic disease from initial treatment until death and, 2) identify clinically-relevant risk factors for the development of metastases. Over a 9-year period, 285 patients treated with transarterial locoregional therapies underwent scheduled imaging follow-up from treatment until death and were categorized by pattern of progression: 1) intrahepatic (increased tumor enhancement/size, development/progression of vascular invasion, new hepatic lesions) progression or 2) extrahepatic (adrenal/bone/lung/lymph node) metastases. Uni/multivariate analyses assessing the risk factors for the development of metastases were performed. The median time from last scan to death was 2.4 months (inter-quartile range: 1.3–4.8 months). The time to development of metastases, vascular invasion and/or new lesions was 13.8 months (confidence interval: 11.3–17.7 months). Of the 209 patients followed until death, only 50 developed extrahepatic metastases (24%). Multivariate analyses identified age <65 years (p=0.038), AFP >200 ng/ml (p=0.04) and vascular invasion (p=0.017) as significant predictors of metastases development. In conclusion, knowledge of the risk factors associated with the development of metastases may help guide assessment of patient prognosis. Since 76% of patients presenting with local disease treated with locoregional therapies die without developing extrahepatic metastases, the notion of HCC as a systemic disease, as detected by imaging, may be reconsidered.
PMCID: PMC3322252  PMID: 22109811
hepatocellular carcinoma; embolization; imaging; progression
12.  Alpha-fetoprotein Response Correlates with EASL Response and Survival in Solitary Hepatocellular Carcinoma Treated with Trans-arterial Therapies: A Subgroup Analysis 
Journal of Hepatology  2012;56(5):1112-1120.
Background and Aims
Alpha-fetoprotein (AFP) is a universally recognized tumor marker in hepatocellular carcinoma (HCC). Its utility in assessing response to treatment remains controversial. We sought to study the: a) correlation between AFP response and imaging response, and b) ability of AFP, EASL and WHO response to predict survival outcomes in patients with solitary HCC.
629 HCC patients were treated with transarterial locoregional therapies over an 11-year period. To eliminate confounding factors, we included patients with single tumors, baseline AFP≥200 ng/mL, and no extrahepatic disease; this identified our study cohort of 51 patients. AFP response was defined as >50% decrease from baseline; this was correlated to EASL and WHO response criteria by Kappa agreement, Pearson correlation and receiver operating curves. Survival analyses were performed by Landmark, risk-of-death and Mantel-Byar methodologies. None of the patients received sorafenib.
Three months post-treatment, AFP and EASL response correlated well (Kappa: 0.83; Pearson: 0.84); the sensitivity, specificity, positive and negative predictive values of AFP in predicting EASL response at 3 months were 96.6%, 85.7%, 92.3% and 93.3% respectively. Correlation with WHO response was low. From the 3-month landmark, WHO, EASL and AFP responders survived longer than nonresponders (P=0.006, 0.0001 and <0.0001 respectively). The risk of death was lower for EASL and AFP responders by both risk-of-death and Mantel-Byar methodologies (P<0.05).
Response by AFP and EASL are predictors of survival outcome in patients with solitary HCC. AFP correlates with imaging response assessment by EASL guidelines. Achieving AFP response should be one of the therapeutic intents of locoregional therapies.
PMCID: PMC3328660  PMID: 22245905
transarterial chemoembolization; radioembolization; hepatocellular carcinoma; imaging response, AFP response, correlation, survival
13.  Human Acellular Dermis versus Submuscular Tissue Expander Breast Reconstruction: A Multivariate Analysis of Short-Term Complications 
Archives of Plastic Surgery  2013;40(1):19-27.
Acellular dermal matrix (ADM) allografts and their putative benefits have been increasingly described in prosthesis based breast reconstruction. There have been a myriad of analyses outlining ADM complication profiles, but few large-scale, multi-institutional studies exploring these outcomes. In this study, complication rates of acellular dermis-assisted tissue expander breast reconstruction were compared with traditional submuscular methods by evaluation of the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP) registry.
Patients who underwent immediate tissue expander breast reconstruction from 2006-2010 were identified using surgical procedure codes. Two hundred forty tracked variables from over 250 participating sites were extracted for patients undergoing acellular dermis-assisted versus submuscular tissue expander reconstruction. Thirty-day postoperative outcomes and captured risk factors for complications were compared between the two groups.
A total of 9,159 patients underwent tissue expander breast reconstruction; 1,717 using acellular dermis and 7,442 with submuscular expander placement. Total complications and reconstruction related complications were similar in both cohorts (5.5% vs. 5.3%, P=0.68 and 4.7% vs. 4.3%, P=0.39, respectively). Multivariate logistic regression revealed body mass index and smoking as independent risk factors for reconstructive complications in both cohorts (P<0.01).
The NSQIP database provides large-scale, multi-institutional, independent outcomes for acellular dermis and submuscular breast reconstruction. Both thirty-day complication profiles and risk factors for post operative morbidity are similar between these two reconstructive approaches.
PMCID: PMC3556529  PMID: 23362476
Alloderm; Mammaplasty; Breast implantation; Tissue expansion devices; Complications
14.  NUTORC—a transdisciplinary health services and outcomes research team in transplantation 
The field of solid organ transplantation has historically concentrated research efforts on basic science and translational studies. However, there has been increasing interest in health services and outcomes research. The aim was to build an effective and sustainable, inter- and transdisciplinary health services and outcomes research team (NUTORC), that leveraged institutional strengths in social science, engineering, and management disciplines, coupled with an international recognized transplant program. In 2008, leading methodological experts across the university were identified and intramural funding was obtained for the NUTORC initiative. Inter- and transdisciplinary collaborative teams were created across departments and schools within the university. Within 3 years, NUTORC became fiscally sustainable, yielding more than tenfold return of the initial investment. Academic productivity included funding for 39 grants, publication of 60 manuscripts, and 166 national presentations. Sustainable educational opportunities for students were created. Inter- and transdisciplinary health services and outcomes research in transplant can be innovative and sustainable.
PMCID: PMC3647618  PMID: 23667403
Transdisciplinary research teams; Health Services and Outcomes Research; Educational opportunities; Academic productivity; Sustainable research efforts
15.  A Comprehensive Risk Assessment of Mortality Following Donation after Cardiac Death Liver Transplant – An Analysis of the National Registry 
Journal of hepatology  2011;55(4):808-813.
Background and Aims
Organ scarcity has resulted in increased utilization of donation after cardiac death (DCD) donors. Prior analysis of patient survival following DCD liver transplantation has been restricted to single institution cohorts and a limited national experience. We compared the current national experience with DCD and DBD livers to better understand survival after transplantation.
We compared 1,113 DCD and 42,254 DBD recipients from the Scientific Registry of Transplant Recipients database between 1996 and 2007. Patient survival was analyzed using Kaplan-Meier methodology and Cox regression.
DCD recipients experienced worse patient survival compared to DBD recipients (p<0.001). One and three year survival was 82% and 71% for DCD compared to 86% and 77% for DBD recipients. Moreover, DCD recipients required re-transplantation more frequently (DCD 14.7% versus DBD 6.8%, p<0.001), and re-transplantation survival was markedly inferior to survival after primary transplant irrespective of graft type. Amplification of mortality risk was observed when DCD was combined with cold ischemia time > 12hours (HR=1.81), shared organs (HR=1.69), recipient hepatocellular carcinoma (HR=1.80), recipient age >60 years (HR=1.92), and recipient renal insufficiency (HR=1.82).
DCD recipients experience signficantly worse patient survival after transplantation. This increased risk of mortality is comparable in magnitude to, but often exacerbated by other well-established risk predictors. Utilization decisions should carefully consider DCD graft risks in combination with these other factors.
PMCID: PMC3177011  PMID: 21338639
16.  Radiographic Response to Locoregional Therapy in Hepatocellular Carcinoma Predicts Patient Survival Times 
Gastroenterology  2011;141(2):526-535.e2.
Background & Aims
It is not clear whether survival times of patients with hepatocellular carcinoma (HCC) are associated with their response to therapy. We analyzed the association between tumor response and survival times of patients with HCC who were treated with locoregional therapies (LRTs; chemoembolization and radioembolization).
Patients received LRTs over a 9-year period (n=463). Patients with metastases, portal venous thrombosis, or who had received transplants were excluded; 159 patients with Child-Pugh≤B7 were analyzed. Response (based on European Association for Study of the Liver [EASL] or World Health Organization [WHO] criteria) was associated with survival times using the landmark, risk-of-death, and Mantel-Byar methodologies. In a subanalysis, survival times of responders were compared to those of patients with stable disease (SD) and progressive disease (PD).
Based on 6-month data, in landmark analysis, responders survived longer than nonresponders (based on EASL but not WHO criteria: P=0.002 and 0.0694). The risk of death was also lower for responders (based on EASL but not WHO criteria: P=0.0463 and 0.707). Landmark analysis of 12-month data showed that responders survived longer than nonresponders (P=<0.0001 and 0.004, based on EASL and WHO criteria, respectively). The risk of death was lower for responders (P=0.0132 and 0.010, based on EASL and WHO criteria, respectively). By the Mantel-Byar method, responders had longer survival than nonresponders, based on EASL criteria (P<0.0001; P=0.596 with WHO criteria). In the subanalysis, responders lived longer than patients with SD or PD.
Radiographic response to LRTs predicts survival time. EASL criteria for response more consistently predicted survival times than WHO criteria. The goal of LRT should be to achieve a radiologic response, rather than to stabilize disease.
PMCID: PMC3152626  PMID: 21664356
embolization; liver cancer; radiology; treatment
17.  Meta-Analysis of Maternal and Neonatal Outcomes Associated with the Use of Insulin Glargine versus NPH Insulin during Pregnancy 
As glargine, an analog of human insulin, is increasingly used during pregnancy, a meta-analysis assessed its safety in this population. A systematic literature search identified studies of gestational or pregestational diabetes comparing use of insulin glargine with human NPH insulin, with at least 15 women in both arms. Data was extracted for maternal outcomes (weight at delivery, weight gain, 1st/3rd trimester HbA1c, severe hypoglycemia, gestation/new-onset hypertension, preeclampsia, and cesarean section) and neonatal outcomes (congenital malformations, gestational age at delivery, birth weight, macrosomia, LGA, 5 minute Apgar score >7, NICU admissions, respiratory distress syndrome, neonatal hypoglycemia, and hyperbilirubinemia). Relative risk ratios and weighted mean differences were determined using a random effect model. Eight studies of women using glargine (331) or NPH (371) were analyzed. No significant differences in the efficacy and safety-related outcomes were found between glargine and NPH use during pregnancy.
PMCID: PMC3362948  PMID: 22685467
18.  Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma 
Gastroenterology  2010;140(2):497-507.e2.
Background and Aims
Chemoembolization is a standard treatment for hepatocellular carcinoma (HCC). Radioembolization with 90Y microspheres is a new, transarterial approach to radiation therapy. We performed a comparative effectiveness analysis of these therapies in patients with HCC.
We collected data from 463 patients who were treated with transarterial locoregional therapies (chemoembolization or radioembolization) over a 9-year period. We excluded patients who were not appropriate for comparison and analyzed data from 245 (122 who received chemoembolization and 123 who received radioembolization). Patients were followed for signs of toxicity; all underwent imaging analysis at baseline and follow-up timepoints. Overall survival was the primary outcome measure. Secondary outcomes included safety, response rate, and time-to-progression. Uni- and multi-variate analyses were performed.
Abdominal pain and increased transaminase activity were more frequent following chemoembolization (P<.05). There was a trend that patients treated with radioembolization had a higher response rate than with chemoembolization (49% vs. 36%, P=0.104). Although time-to-progression was longer following radioembolization than chemoembolization (13.3 months vs 8.4 months, P=0.046), median survival times were not statistically different (17.4 months vs 20.5 months, P=0.232). Among patients with intermediate-stage disease, survival was similar between groups that received chemoembolization (17.5 months) and radioembolization (17.2 months, P=0.42).
Patients with HCC treated by chemoembolization or radioembolization with 90Y microspheres had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemoembolization. Post-hoc analyses of sample size indicated that a randomized study with >1000 patients would be required to establish equivalence of survival times between patients given the different therapies.
PMCID: PMC3129335  PMID: 21044630
liver cancer; radiotherapy; chemotherapy; clinical trial
19.  Adductor Myocutaneous Flap Coverage for Hip and Pelvic Disarticulations of Sarcomas with Buttock Contamination 
Hip disarticulation and hemipelvectomy are alternatives to limb-salvage procedures for patients with extensive tumors of the upper thigh and buttocks. In cases when neither the conventional posterior gluteus maximus flap nor the anterior quadriceps flap can be used because of the location of the tumor, a medial adductor myocutaneous flap may be an alternative.
Description of Technique
The flap is outlined over the anteromedial thigh. The distal extent is at the level of the adductor hiatus. The common femoral vessels and nerve are traced, preserved, and protected. The adductor muscles then are divided above their insertions on the femur and preserved with the flap. En bloc removal of the tumor is performed by either hip disarticulation or hemipelvectomy. The long adductor myocutaneous flap is brought up laterally and proximally to close the wound.
Patients and Methods
We reviewed four patients who underwent a medial adductor myocutaneous flap after either hip disarticulation or hemipelvectomy. The medical records and radiographs were analyzed. These patients were followed up for at least a year or until death.
Wide surgical margins were achieved in all four patients and the flap remained viable, with no skin necrosis or flap breakdown. The patients were able to sit on the flap, and one patient was able to wear a prosthesis.
In patients undergoing hip disarticulation or hemipelvectomy where tumor infiltration or inadvertent contamination by previous surgery will not allow the traditional posterior gluteus maximus or anterior quadriceps flap, this unconventional medial adductor myocutaneous flap is a feasible, technically simple option.
Level of Evidence
Level IV therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
PMCID: PMC3008907  PMID: 20632137
20.  Higher Doses of Subcutaneous IgG Reduce Resource Utilization in Patients with Primary Immunodeficiency 
Journal of Clinical Immunology  2011;32(2):281-289.
The recommended dose of IgG in primary immunodeficiency (PID) has been increasing since its first use. This study aimed to determine if higher subcutaneous IgG doses resulted in improved patient outcomes by comparing results from two parallel clinical studies with similar design. One patient cohort received subcutaneous IgG doses that were 1.5 times higher than their previous intravenous doses (mean 213 mg/kg/week), whereas the other cohort received doses identical to previous subcutaneous or intravenous doses (mean 120 mg/kg/week). While neither cohort had any serious infections, the cohort maintained on higher mean IgG dose had significantly lower rates of non-serious infections (2.76 vs. 5.18 episodes/year, P < 0.0001), hospitalization (0.20 vs. 3.48 days/year, P < 0.0001), antibiotic use (48.50 vs. 72.75 days/year, P < 0.001), and missed work/school activity (2.10 vs. 8.00 days/year, P < 0.001). The higher-dose cohort had lower health care utilization and improved indices of well being compared to the cohort treated with traditional IgG doses.
PMCID: PMC3305876  PMID: 22193916
Primary immunodeficiency; subcutaneous IgG replacement therapy; infection rate; hospitalization rate; Hizentra
21.  Longitudinal Changes in Acculturation for Immigrant Women from the Former Soviet Union 
Most research on immigrant acculturation has been conducted with cross-sectional samples, using statistical designs that may not capture different trajectories for the components that contribute to this complex concept. The purpose of this study was to examine change over time in acculturation for 226 women from the former Soviet Union who had lived in the US fewer than eight years when recruited. Using self-report data from four annual waves, growth trajectories were examined in four components of acculturation (American behavior, Russian behavior, English language proficiency, and cultural generativity). Results indicate that these components changed at varying rates. Acculturation is a process with multiple distinct components which should be measured separately to obtain a full profile of change over time.
PMCID: PMC3236557  PMID: 22180661
22.  Crosstalk between mast cells and pancreatic cancer cells contributes to pancreatic tumor progression 
To assess the clinical and pathological significance of mast cell infiltration in human pancreatic cancer and evaluate crosstalk between mast cells and cancer cells in vitro.
Experimental Design
Immunohistochemistry for tryptase was performed on 53 pancreatic cancer specimens. Mast cell counts were correlated with clinical variables and survival. Serum tryptase activity from cancer patients was compared to patients with benign pancreatic disease. In vitro, the effect of pancreatic cancer conditioned media on mast cell migration was assessed. The effect of conditioned media from the human mast cell line, LAD-2, on cancer and normal ductal cell proliferation was assessed by thymidine incorporation. Matrigel invasion assays were used to evaluate the effect of mast cell conditioned media on cancer cell invasion in the presence and absence of a matrix metalloproteinase inhibitor, GM6001.
Mast cell infiltration was significantly increased in pancreatic cancer compared to normal pancreatic tissue [11.4±6.7vs.2.0±1.4(p<0.001)]. Increased infiltrating mast cells correlated with higher grade tumors (p<0.0001) and worse survival. Patients with pancreatic cancer had elevated serum tryptase activity (p<0.05). In vitro, AsPC1 and PANC-1 cells induced mast cell migration. Mast cell conditioned media induced pancreatic cancer cell migration, proliferation and invasion but had no effect on normal ductal cells. Furthermore, the effect of mast cells on cancer cell invasion was in large part MMP-dependent.
Tumor infiltrating mast cells are associated with worse prognosis in pancreatic cancer. In vitro, the interaction between mast cells and pancreatic cancer cells promote tumor growth and invasion.
PMCID: PMC3122919  PMID: 20371681
Mast cells; Pancreatic Adenocarcinoma; Tryptase; Matrix Metalloproteinase
Human immunology  2010;71(6):566-576.
Ex-vivo identification of donor specific unresponsiveness in organ transplant recipients is important for immunosuppression (IS) minimization. We tested three groups of stable living-related-donor-kidney transplant patients upto 11 years post-operatively, i.e., 20 haploidenticals with donor bone marrow cell (DBMC) infusions, 8 non-infused haploidentical controls (haplo-controls) and 11 HLA-identical controls (HLA-Id), using multiple ex vivo immune assays. None developed donor specific antibodies. The majority showed donor specific CTL unresponsiveness from year one onwards. 13/20 DBMC recipients became specifically donor MLR non-reactive. Depletion of donor cells in DBMC recipients still MLR reactive increased donor specific reactivity by 75±36% (p=0.04). Adding them back in low concentration caused antigen specific inhibition. The frequencies of ELISPOT granzyme-B and interferon-γ producing cells somewhat paralleled the CTL and MLR responses. In the transvivo-DTH, 14/19 DBMC recipients demonstrated donor specific unresponsiveness and 16/19 showed “linked suppression”, vs 0/8 and 1/8 haplo-controls and vs. 6/10 and 1/10 HLA-ids respectively. Most importantly, when all 6 assays were performed simultaneously, 10/18 DBMC, 5/10 HLA-id but no haplo-controls were specifically donor unresponsive long-term.
We propose that a cluster-analysis combining these assays will reveal tolerant recipients in whom IS minimization may safely be tested. This appears to have occurred in many DBMC infused recipients.
PMCID: PMC2874115  PMID: 20153397
kidney transplant patients; donor bone marrow infusion; immune assessments; donor specific unresponsiveness
24.  Inoculation Against Falls: Rapid Adaptation By Young And Older Adults To Slips During Daily Activities 
To determine whether aging diminishes one’s ability to rapidly learn to resist falls on repeated-slip exposure across different activities of daily living.
Quasi-experimental controlled trial.
Two university-based research laboratories.
Young (n=35) and older (n=38) adults underwent slips during walking. Young (n=60) and older (n=41) adults underwent slips during sit-to-stands. All (N=174) were healthy and community-dwelling.
Low-friction platforms induced unannounced blocks of 2–8 repeated slips, interspersed with blocks of 3–5 nonslip trials, during the designated task.
Main Outcome Measures
The incidence of falls and balance loss. Dynamic stability (based on center-of-mass position and velocity) and limb support (based on hip height) 300 ms after slip onset.
Under strictly controlled, identical low-friction conditions, all participants experienced balance loss but older adults were over twice as likely as young to fall on the first, unannounced, novel slip in both tasks. Independent of age or task, participants adapted to avoid falls and balance loss, with most adaptation occurring in early trials. By the fifth slip, the incidence of falls and balance loss was less than 5% and 15%, respectively, regardless of age or task. Reductions in falls and balance loss for each task were accomplished through improved control of stability and limb support in both age groups. A rapidly-reversible, age- and task-dependent waning of motor learning occurred after a block of nonslip trials. Adaptation to walk-slips reached steady-state in the second slip block, regardless of age.
The ability to rapidly acquire fall-resisting skills on repeated-slip exposure remains largely intact at older ages and across functional activities. Thus, repeated-slip exposure might be broadly effective in inoculating older adults against falls.
PMCID: PMC2842602  PMID: 20298839
Aging; Learning; Motor skills; Postural balance; Rehabilitation
25.  Obesity and Overweight Prevalence Among Adolescents With Disabilities 
Preventing Chronic Disease  2011;8(2):A41.
We examined overweight and obesity prevalence among adolescents with disabilities by disability type (physical vs cognitive) and demographic factors (sex, age, race/ethnicity).
Parents (N = 662) of adolescents aged 12 to 18 years with disabilities from 49 states responded to an online survey from September 2008 through March 2009.
Prevalence of obesity among adolescents with physical and cognitive disabilities (17.5%) was significantly higher compared with that among adolescents without disabilities (13.0%). Obesity prevalence was higher among males, 18-year-olds, and youths with cognitive disabilities than among females, younger adolescents, and youths with physical disabilities.
The higher prevalence of obesity among youths with disabilities compared with nondisabled youths, particularly in certain subgroups, requires further examination in future surveillance research.
PMCID: PMC3073434  PMID: 21324255

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