Sun City Center, United States
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Vecchio M.,Mario Negri Sud Consortium | Navaneethan S.D.,Mario Negri Sud Consortium | Navaneethan S.D.,Cleveland Clinic | Johnson D.W.,University of Queensland | And 10 more authors.
Clinical Journal of the American Society of Nephrology | Year: 2010

Background and objectives: Sexual dysfunction is very common in patients with chronic kidney disease (CKD), but treatment options are limited. The benefits and harms of existing interventions for treatment of sexual dysfunction were assessed in patients with CKD. Design, setting, participants, & measurements: MEDLINE (1966 to December 2008), EMBASE (1980 to December 2008), and the Cochrane Trial Registry (Issue 4 2008) were searched for parallel and crossover randomized and quasi-randomized trials. Treatment effects were summarized as mean differences (MD) or standardized mean difference (SMD) with 95% confidence intervals (CI) using a random effects model. Results: Fourteen trials (328 patients) were included. Phosphodiesterase-5 inhibitors (PDE5i) compared with placebo significantly increased the overall International Index of Erectile Function-5 (IIEF-5) score (three trials, 101 patients, MD 1.81, 95% CI 1.51 to 2.10), all of its individual domains, and the complete 15-item IIEF-5 (two trials, 80 patients, MD 10.64, 95% CI 5.32 to 15.96). End-of-treatment testosterone levels were not significantly increased by addition of zinc to dialysate (two trials, 22 patients, SMD 0.19 ng/dl, 95% CI -2.12 to 2.50), but oral zinc improved end-of-treatment testosterone levels. There was no difference in plasma luteinizing and follicle-stimulating hormone level at the end of the study period with zinc therapy. Conclusions: PDE5i and zinc are promising interventions for treating sexual dysfunction in CKD. Evidence supporting their routine use in CKD patients is limited. There is an unmet need for studying interventions for male and female sexual dysfunction in CKD considering the significant disease burden. Copyright © 2010 by the American Society of Nephrology.


Howard K.,University of Sydney | Jan S.,George Institute for Global Health | Rose J.,University of Sydney | Chadban S.,Royal Prince Alfred Hospital | And 13 more authors.
BMC Public Health | Year: 2011

Background: Transplantation is the treatment of choice for people with severe organ failure. However, demand substantially exceeds supply of suitable organs; consequently many people wait months, or years to receive an organ. Reasons for the chronic shortage of deceased organ donations are unclear; there appears to be no lack of 'in principle' public support for organ donation. Methods/Design. The PAraDOx Study examines community preferences for organ donation policy in Australia. The aims are to 1) determine which factors influence decisions by individuals to offer their organs for donation and 2) determine the criteria by which the community deems the allocation of donor organs to be fair and equitable. Qualitative and quantitative methods will be used to assess community preferences for organ donation and allocation. Focus group participants from the general community, aged between 18-80, will be purposively sampled to ensure a variety of cultural backgrounds and views on organ donation. Each focus group will include a ranking exercise using a modified nominal group technique. Focus groups of organ recipients, their families, and individuals on a transplant waiting list will also be conducted. Using the qualitative work, a discrete choice study will be designed to quantitatively assess community preferences. Discrete choice methods are based on the premise that goods and services can be described in terms of a number of separate attributes. Respondents are presented with a series of choices where levels of attributes are varied, and a mathematical function is estimated to describe numerically the value respondents attach to different options. Two community surveys will be conducted in approximately 1000 respondents each to assess community preferences for organ donation and allocation. A mixed logit model will be used; model results will be expressed as parameter estimates (β) and the odds of choosing one option over an alternative. Trade-offs between attributes will also be calculated. Discussion. By providing a better understanding of current community preferences in relation to organ donation and allocation, the PAraDOx study will highlight options for firstly, increasing the rate of organ donation and secondly, allow for more transparent and equitable policies in relation to organ allocation. © 2011 Howard et al; licensee BioMed Central Ltd.


Joseph P.D.,Center for Kidney Research | Joseph P.D.,Childrens Hospital at Westmead | Joseph P.D.,Discipline of Adolescent and Child Health | Craig J.C.,Center for Kidney Research | And 5 more authors.
Pediatrics | Year: 2016

Background and Objective: The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. METHODS: Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low-to middle-income countries and high-income countries. The transcripts were thematically analyzed. RESULTS: Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). CONCLUSIONS: Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration, establishing centralized trials infrastructure, and aligning research to child health priorities to encourage trials that address global child health care needs. © 2016 by the American Academy of Pediatrics.


Williams G.J.,Childrens Hospital at Westmead | Williams G.J.,Center for Kidney Research | Macaskill P.,Childrens Hospital at Westmead | Kerr M.,Center for Kidney Research | And 10 more authors.
Pediatric Pulmonology | Year: 2013

Background: Consolidation on chest radiography is widely used as the reference standard for defining pneumonia and variability in interpretation is well known but not well explored or explained. Methods: Three pediatric sub-specialists (infectious diseases, radiology and respiratory medicine) viewed 3,033 chest radiographs in children aged under 5 years of age who presented to one Emergency Department (ED) with a febrile illness. Radiographs were viewed blind to clinical information about the child and blind to findings of other readers. Each chest radiograph was identified as positive or negative for consolidation. Percentage agreement and kappa scores were calculated for pairs of readers. Prevalence of consolidation and reader sensitivity/specificity was estimated using latent class analysis. Results: Using the majority rule, 456 (15%) chest radiographs were positive for consolidation while the latent class estimate was 17%. The radiologist was most likely (21.3%) and respiratory physician least likely (13.7%) to diagnose consolidation. Overall percentage agreement for pairs of readers was 85-90%. However, chance corrected agreement between the readers was moderate, with kappa scores 0.4-0.6 and did not vary with patient characteristics (age, gender, and presence of chronic illness). Estimated sensitivity ranged from 0.71 to 0.81 across readers, and specificity 0.91 to 0.98. Conclusions: Overall agreement for identification of consolidation on chest radiographs was good, but agreement adjusted for chance was only moderate and did not vary with patient characteristics. Clinicians need to be aware that chest radiography is an imperfect test for diagnosing pneumonia and has considerable variability in its interpretation. © 2013 Wiley Periodicals, Inc.


Wong G.,Westmead Hospital | Wong G.,University of Sydney | Wong G.,Center for Kidney Research | Chapman J.R.,Westmead Hospital | And 2 more authors.
Kidney International | Year: 2014

Cancer is a major cause of morbidity among those with kidney transplants. Farrugia et al. examined the overall and site-specific risk of cancer death among kidney transplant recipients. Cancer outcomes, particularly for those with a history of cancer prior to transplantation, are poor. The overall risk of death attributed to cancer in patients with kidney transplants is increased at least tenfold over that in cancer patients in the general population. © 2014 International Society of Nephrology.

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