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1.  Advance Care Treatment Plan (ACT-Plan) for African American Family Caregivers: A Pilot Study 
Dementia (London, England)  2012;13(1):10.1177/1471301212449408.
Research is limited on end-of-life (EOL) treatment decisions made by African American (AA) family caregivers. In a pilot study we examined feasibility of implementing an advance care treatment plan (ACT-Plan), a group-based education intervention, with AA dementia caregivers. Cardiopulmonary resuscitation (CPR), mechanical ventilation (MV) and tube feeding (TF) were EOL treatments discussed in the ACT-Plan. In a 4-week pre/posttest two-group design at urban adult daycare centers, 68 caregivers were assigned to the ACT-Plan or attention-control health promotion conditions. Theoretically based, the ACT-Plan included strategies to enhance knowledge, self-efficacy, and behavioral skills to make EOL treatment plans in advance. Findings strongly suggest that the ACT-Plan intervention is feasible and appropriate for AA caregivers. Self-efficacy and knowledge about dementia, CPR, MV and TF increased with ACT-Plan but not attention control condition. More ACT-Plan participants than control participants developed an advance care plan for relatives with dementia. Findings warrant a randomized efficacy trial.
PMCID: PMC3882894  PMID: 24381040
African-Americans; advance care planning; dementia caregivers
2.  A Review of Cardiovascular Outcomes in the Treatment of People with Type 2 Diabetes 
Diabetes Therapy  2014;5(2):385-402.
Cardiovascular disease (CVD) is a common and serious complication of type 2 diabetes mellitus (T2DM) often linked to the increased morbidity and mortality associated with T2DM. Monitoring and treating risk factors for CVD are important elements of diabetes management. This review aims to examine CV risk in people with relatively early and mild diabetes who are at substantial risk of CVD; it considers the impact of insulin therapy on this risk by focusing on key studies in patients with diabetes.
A literature search was carried out using PubMed to identify key publications, between 2008 and 2013, related to insulin and its possible effect on CVD. This review examines CV risk in diabetes and the impact of insulin therapy on this risk.
Studies have shown that treatment with insulin glargine is associated with marked improvement in the lipid profile of people with T2DM. Intensive insulin therapy has been shown to lower mortality rates in people with diabetes following acute myocardial infarction after 1 year. Retrospective data also indicate that insulin reduces the risk of CVD events, regardless of whether people had comorbidities known to increase CV risk. The prospective ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial found that treatment with insulin glargine had a neutral effect with regard to CV outcomes in people with prediabetes or early diabetes, compared with standard care.
Other ongoing, large-scale studies of insulin therapy should provide further insights into whether or not insulin therapy can influence long-term CV outcomes.
Electronic supplementary material
The online version of this article (doi:10.1007/s13300-014-0091-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4269651  PMID: 25515096
Cardiovascular disease; Cardiovascular risk; Glycated hemoglobin; Glycemic control; HbA1c; Hypoglycemia; Insulin glargine; Type 2 diabetes; Weight gain
3.  BRIT1 regulates p53 stability and functions as a tumor suppressor in breast cancer 
Carcinogenesis  2013;34(10):2271-2280.
In humans, the gene encoding the BRCA1 C terminus-repeat inhibitor of human telomerase expression 1 (BRIT1) protein is located on chromosome 8p23.1, a region implicated in the development of several malignancies, including breast cancer. Previous studies by our group and others suggested that BRIT1 might function as a novel tumor suppressor. Thus, identifying the molecular mechanisms that underlie BRIT1’s tumor suppressive function is important to understand cancer etiology and to identify effective therapeutic strategies for BRIT1-deficient tumors. We thus investigated the role of BRIT1 as a tumor suppressor in breast cancer by using genetic approaches. We discovered that BRIT1 functions as a post-transcriptional regulator of p53 expression. BRIT1 regulates p53 protein stability through blocking murine double minute 2-mediated p53 ubiquitination. To fully demonstrate the role of BRIT1 as a tumor suppressor, we depleted BRIT1 in normal breast epithelial cells. We found that knockdown of BRIT1 caused the oncogenic transformation of normal mammary epithelial cells. Furthermore, ectopic expression of BRIT1 effectively suppressed breast cancer cell proliferation and colony formation in vitro and tumor growth in vivo. Taken together, our study provides new insights into the biological functions of BRIT1 as a tumor suppressor in human breast cancer.
PMCID: PMC3786380  PMID: 23729656
4.  Reproductive Health CHOICES for Young Adults with Sickle Cell Disease or Trait: Randomized Controlled Trial Immediate Posttest Effects 
Nursing research  2013;62(5):352-361.
People with sickle cell disease (SCD) or sickle cell trait (SCT) may not have information about genetic inheritance needed for making informed reproductive health decisions. CHOICES is a web-based, multimedia educational intervention that provides information about reproductive options and consequences to help those with SCD or SCT identify and implement an informed parenting plan. Efficacy of CHOICES compared with usual care must be evaluated.
The purpose was to compare immediate posttest effects of CHOICES versus an attention control usual care intervention (e-Book) on SCD/SCT-related reproductive health knowledge, intention, and behavior.
In a randomized controlled study, we recruited subjects with SCD/SCT from clinics, community settings, and online networks with data collected at sites convenient to the 234 subjects with SCD (n = 136) or SCT (n = 98) (age ranged from18-35 years, 65% were female, and 94% were African American). Subjects completed a measure of sickle cell reproductive knowledge, intention, and behavior before and immediately after the intervention.
Compared to the e-Book group, the CHOICES group had significantly higher average knowledge scores and probability of reporting a parenting plan to avoid SCD or SCD and SCT when pretest scores were controlled. Effects on intention and planned behavior were not significant. The CHOICES group showed significant change in their intention and planned behavior; the e-Book group did not show significant change in their intention, but their planned behavior differed significantly.
Initial efficacy findings are encouraging but warrant planned booster sessions and outcome follow-ups to determine sustained intervention efficacy on reproductive health knowledge, intention, and actual behavior of persons with SCD/SCT.
PMCID: PMC3805179  PMID: 23995469
sickle cell disease; sickle cell trait; reproductive behavior; young adult; randomized controlled trial
5.  The Relationships among Satisfaction with Social Support, Quality of Life, and Survival 5 to 10 Years after Heart Transplantation 
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).
Thus, the purposes of our retrospective analyses of a prospective, longitudinal study were to examine (1) the relationship between satisfaction with social support and post HT health-related quality of life (HRQOL) and survival, and (2) whether two types of social support (emotional and tangible) were predictors of survival and HRQOL.
Data were collected from 555 HT patients over a 5-year period (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, and medical records review. Statistical analyses included t-tests, correlations, Kaplan-Meier survival actuarials, and linear and multivariable regression.
Patients were very satisfied with overall social support from 5 to 10 years after HT (0=very satisfied, 1=very dissatisfied) which was stable across time (p = 0.74). Satisfaction with emotional social support (p = 0.53) and tangible social support (p = 0.61) also remained stable over time. When stratified into low, medium and high levels of satisfaction, satisfaction with social support was not related to survival (p = 0.24). At 5 years, overall satisfaction with social support was a predictor of HRQOL ( r2=.59, p<.0001), and satisfaction with emotional social support was a predictor of HRQOL at 10 years post HT ( r2=.66, p<.0001).
Patients were very satisfied over time with emotional and tangible social support. While social support explained QOL outcomes, it did not predict survival. Knowledge of relationships among social support, stress, and outcomes may assist clinicians to address social support needs and resources long-term after HT.
PMCID: PMC3432292  PMID: 22580630
Social support; heart transplantation; quality of life; survival
6.  Allospecific Regulatory Effects of Sirolimus and Tacrolimus in the Human Mixed Lymphocyte Reaction 
Transplantation  2011;91(2):199-206.
Tacrolimus (TAC) and sirolimus (SRL), two commonly used immunosuppressive agents, have demonstrated contrasting immunoregulatory effects. We recently described factors affecting the generation of allospecific CD4+CD25High forkhead/winged helix transcription factor P3 (FOXP3+) T-regulatory (Treg) cells in mixed lymphocyte reaction (Treg MLR) and now report additional findings on the effects of TAC and SRL.
TAC, SRL, or media without agents were added separately to MLRs using human leukocyte antigen two DR-matched and -mismatched healthy volunteers and prekidney transplant donor/recipient pairs. Concentrations correlated with subtherapeutic and therapeutic blood levels. Stimulation indices of 3H-TDR uptake, cell proliferation, and the generation of carboxy-fluorescein diacetate succinimidyl ester (CFSE) labeled CD4+CD25HighFOXP3+ cells by flow cytometry were initially compared. Each group of (non-CFSE labeled) MLR-generated cells were then added as third components to CFSE-labeled responding cells in freshly prepared primary MLRs, to determine allospecific and nonspecific inhibitory and Treg recruitment effects.
TAC inhibited stimulation indices and CD4+CD25High FOXP3+ cell generation in both human leukocyte antigen DR-matched and -mismatched pairs, particularly at therapeutic levels (≥5 ng/mL). SRL had an equivalent effect in matched pairs but was associated with a significantly higher % generation of CD4+CD25HighFOXP3+ cells than TAC. SRL-MLR-generated Tregs added as third components allospecifically inhibited MLR proliferation and recruited additional CFSE-labeled autologous Tregs compared with addition of TAC- or media-MLR-generated Tregs.
Calcineurin and mammalian target of rapamycin inhibitors have disparate effects on allospecific Treg generation using the Treg MLR. This assay can thereby be helpful in assessing allospecific regulatory effects of diverse immunosuppressive agents.
PMCID: PMC4109156  PMID: 21239962
Mixed lymphocyte reaction; Regulatory T cells; FOXP3; Calcineurin inhibitor agents; mTOR inhibition
7.  Reduced vasodilator function following acute resistance exercise in obese women 
Obesity contributes to stress induced impairments in endothelium-dependent vasodilation (EDV), a precursor to atherosclerosis. Since obesity is associated with inflammation and oxidative stress, we sought to determine if a single bout of strenuous weight lifting (SWL) reduces EDV among sedentary obese adults. Participants included 9 obese (OB) (BMI 30.0–40.0 kg/m2) and 8 lean (LN) (BMI 18.5–24.9 kg/m2) sedentary young women. All participants underwent a single bout of SWL using a progressive leg-press protocol. Brachial artery flow-mediated dilation (FMD) (an index of EDV) was determined using ultrasonography before and after SWL. Sublingual nitroglycerin (NTG) was used to determine brachial artery endothelium-independent vasodilation following SWL. Brachial artery FMD was significantly reduced in OB and LN women (LN: 6.4 ± 1.6%, p = 0.22) after SWL. There was no difference in the magnitude of change pre- and post-SWL between groups (OB: −2.4 ± 0.6% and LN: −2.2 ± 1.6%, p = 0.84). Dilation to NTG was lower in OB (21.6 ± 1.3%) compared to LN women (27.6 ± 2.1%, p = 0.02) and associated with body weight (r = −0.70, p = 0.01). These data suggest that EDV is reduced in woman after acute resistance exercise. Dilations to NTG were lower in obese compared to lean woman and associated with body weight suggesting that changes in sensitivity of blood vessels to NO occurs during obesity. These findings may be important for understanding vascular risk following acute exercise in obesity.
PMCID: PMC4083188  PMID: 25071598
endothelium; vasodilation; acute exercise; obesity; women
8.  Zinc finger protein 668 interacts with Tip60 to promote H2AX acetylation after DNA damage 
Cell Cycle  2013;12(13):2033-2041.
Many tumor suppressors play an important role in the DNA damage pathway. Zinc finger protein 668 (ZNF668) has recently been identified as one of the potential tumor suppressors in breast cancer, but its function in DNA damage response is unknown. Herein, we report that ZNF668 is a regulator of DNA repair. ZNF668 knockdown impairs cell survival after DNA damage without affecting the ATM/ATR DNA-damage signaling cascade. However, recruitment of repair proteins to DNA lesions is decreased. In response to IR, ZNF668 knockdown reduces Tip60-H2AX interaction and impairs IR-induced histone H2AX hyperacetylation, thus impairing chromatin relaxation. Impaired chromatin relaxation causes decreased recruitment of repair proteins to DNA lesions, defective homologous recombination (HR) repair and impaired cell survival after IR. In addition, ZNF668 knockdown decreased RPA phosphorylation and its recruitment to DNA damage foci in response to UV. In both IR and UV damage responses, chromatin relaxation counteracted the impaired loading of repair proteins and DNA repair defects in ZNF668-deficient U2OS cells, indicating that impeded chromatin accessibility at sites of DNA breaks caused the DNA repair defects observed in the absence of ZNF668. Our findings suggest that ZNF668 is a key molecule that links chromatin relaxation with DNA damage response in DNA repair control.
PMCID: PMC3737306  PMID: 23777805
ZNF668; Tip60; H2AX acetylation; DNA damage repair
9.  Immunoregulatory profiles in liver transplant recipients on different immunosuppressive agents 
Human immunology  2009;70(3):146-150.
We compared peripheral blood immunophenotyping in 31 adult liver transplant recipients on differing long-term immunosuppressive (IS) monotherapy with and without peri-transplantation alemtuzumab (AL) induction. All patients had been stable on monotherapy with either sirolimus (SRL) (n = 10) or without SRL (tacrolimus (TAC) (n = 10), mycophenolate mofetil (MMF) (n = 11)) for more than 6 months. Five-color flow cytometry for putative “regulatory” T and dendritic cells as well as serum assays for soluble HLA-G (sHLA-G) were performed. The SRL monotherapy group had significantly higher percentages of CD4+CD25high+ Foxp3+ T cells (1.3 ± 1.0) compared with the non-SRL group (0.7 ± 0.6) (p = 0.04). The SRL effect was even higher in a subset with prior AL induction and no prior hepatitis C or rejection (1.7 ± 0.2) compared with all other subgroups (0.7 ± 0.6) (p = 0.02). TAC patients showed significantly higher “regulatory” DC2:DC1 ratios (10 ± 7.6) compared with non-TAC patients (4.1 ± 2.3) (p = 0.04). Although sHLA-G levels appeared higher in TAC patients, the differences were not statistically significant. In conclusion, IS monotherapy provides an opportunity to investigate regulatory roles of individual agents. SRL maintenance and prior AL induction in subsets of patients appeared to show a regulatory T cell immunophenotype. However, TAC patients may have other regulatory characteristics, supporting the need for larger, prospective studies to clarify differences.
PMCID: PMC4066558  PMID: 19141306
Regulatory T cells; Dendritic cells; Immunophenotyping; Liver transplantation; Immunosuppression
10.  Fatigue in Women with Type 2 Diabetes 
The Diabetes educator  2012;38(5):662-672.
PMCID: PMC4006984  PMID: 22713262
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
12.  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
13.  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
14.  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
15.  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
16.  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
17.  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
18.  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
19.  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
20.  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
21.  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
22.  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
23.  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
24.  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
25.  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

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