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Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations

2012-06-22T10:14:59Z

A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo (“assay sensitivity”). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

Construct validation of a physical model colonsocopy simulator

2012-06-22T09:23:34Z

Construct validity of the Quality of Upper Extremity Skills Test for children with cerebral palsy

2012-11-15T12:03:38Z

Consumer perceptions of the effectiveness of a breast care nurse in providing holistic, coordinated care to women with breast cancer

Eley, Robert og Rogers-Clark, Cath — 2012-10-15T12:23:33Z

Continuity and discontinuity of trouble sleeping behaviors from early childhood to young adulthood in a large Australian community-based-birth cohort study

2013-01-06T00:10:04Z

Continuous beta-lactam infusion in critically ill patients: the clinical evidence

2012-12-14T17:28:20Z

There is controversy over whether traditional intermittent bolus dosing or continuous infusion of beta-lactam antibiotics is preferable in critically ill patients. No significant difference between these two dosing strategies in terms of patient outcomes has been shown yet. This is despite compelling in vitro and in vivo pharmacokinetic/pharmacodynamic (PK/PD) data. A lack of significance in clinical outcome studies may be due to several methodological flaws potentially masking the benefits of continuous infusion observed in preclinical studies. In this review, we explore the methodological shortcomings of the published clinical studies and describe the criteria that should be considered for performing a definitive clinical trial. We found that most trials utilized inconsistent antibiotic doses and recruited only small numbers of heterogeneous patient groups. The results of these trials suggest that continuous infusion of beta-lactam antibiotics may have variable efficacy in different patient groups. Patients who may benefit from continuous infusion are critically ill patients with a high level of illness severity. Thus, future trials should test the potential clinical advantages of continuous infusion in this patient population. To further ascertain whether benefits of continuous infusion in critically ill patients do exist, a large-scale, prospective, multinational trial with a robust design is required.

Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicentre double-blind, randomised controlled trial.

2012-12-05T16:53:31Z

Contribution of autonomic dysfunction to abnormal exercise blood pressure in type 2 diabetes mellitus

2013-03-10T01:14:57Z

Contribution of autonomic dysfunction to abnormal exercise blood pressure in type 2 diabetes mellitus

2012-11-23T10:55:38Z

Control of Fluoroquinolone Resistance through Successful Regulation, Australia

2012-11-06T10:59:14Z

Convective transport of highly plasma protein bound drugs facilitates direct penetration into deep tissues after topical application

2012-05-07T19:18:31Z

Conventionally accepted risk factors do not explain higher rates of middle ear disease in remote Indigenous children: an ecological study

2012-11-15T12:15:58Z

No abstract is available for this article.

Co-payments in health insurance and their impact in a developing country – evidence from a quasi-natural experiment

Nguyen, Ha Trong og Connelly, Luke — 2012-09-14T11:48:15Z

Though the impact of co-payments on health care demand is well documented in developed countries, evidence from developing countries is rare. In this paper, we contribute to this scarcity by analysing the impact of increasing co-payments in a developing country, namely Vietnam. In 2007, the Vietnam government reintroduced a co-payment of 20 percent for individuals with voluntary health insurance. Because individuals with compulsory health insurance and the uninsured were exempted from the increase in co-payments, this policy can be regarded as a quasi-natural experiment. We use a difference-in-difference approach to examine whether the increase in co-payment effectively reduces the demand for health care services. We find it has no significant negative impact on health care demand. This finding holds with different control groups, outcomes and estimators.

CoralWatch: education, monitoring, and sustainability through citizen science

2012-09-23T00:13:32Z

CoralWatch, launched in 2002, is a citizen-science program that seeks to integrate education and global reef monitoring by examining coral bleaching and uses a monitoring network to educate the public about reef biology, climate change, and environmental stewardship. The organization's development from research and monitoring to education and ecotourism has presented a number of challenges.

Corneal sensitivity is related to established measures of diabetic peripheral neuropathy

2012-06-25T09:59:12Z

Correlation of MRI-derived apparent diffusion coefficients in newly diagnosed gliomas with [18F]-Fluoro-L-Dopa PET: what are we really measuring with minimum ADC?

2013-02-13T13:52:24Z

Correlation of tumour BRAF mutations and MLH1 methylation with germline mismatch repair (MMR) gene mutation status: a literature review assessing utility of tumour features for MMR variant classification

2012-09-03T00:46:14Z

Corticosteroid therapy in IgA nephropathy

2012-07-31T16:14:24Z

The benefits and risks of steroids for the treatment of IgA nephropathy remain uncertain. We systematically searched MEDLINE, EMBASE, and the Cochrane Library for randomized, controlled trials of corticosteroid therapy for IgA nephropathy published between 1966 and March 2011.We identified nine relevant trials that included 536 patients who had urinary protein excretion >1 g/d and normal renal function. Forty-six (8.6%) of these patients developed a kidney failure event, defined as doubling of the serum creatinine/halving of the GFR or ESRD. Overall, steroid therapy was associated with a lower risk for kidney failure (relative risk, 0.32 [95% confidence interval [CI], 0.15-0.67]; P=0.002) and a reduction in proteinuria (weighted mean difference, 20.46 g/d [95% CI, 20.63 to 20.29 g/d]), with no evidence of heterogeneity in these outcomes. Subgroup analysis suggested that the dose modifies the effect of steroids for renal protection (P for heterogeneity=0.030): Relatively high-dose and short-term therapy (prednisone >30 mg/d or high-dose pulse intravenous methylprednisolone with duration ≤1 year) produced significant renal protection, whereas low-dose, long-term steroid use did not. Steroid therapy was associated with a 55% higher risk for adverse events. The quality of included studies was low, however, limiting the generalizability of the results. In conclusion, steroids appear to provide renal protection in patients with IgA nephropathy but increase the risk for adverse events. Reliably defining the efficacy and safety of steroids in IgA nephropathy requires a high-quality trial with a large sample size.

Cost minimization analysis of laparoscopic sacral colpopexy and total vaginal mesh

Maher, Christopher F. og Connelly, Luke B. — 2012-05-28T00:00:00Z

Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: Results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

2012-11-06T12:51:15Z

Critical care of the potential organ donor

2012-09-10T14:32:16Z

Cross-sectional analysis of association between socioeconomic status and utilization of primary total hip joint replacements 2006-7: Australian orthopaedic association national joint replacement registry

2012-09-01T00:00:00Z

CT and radiographic analysis of sagittal profile changes following thoracoscopic anterior scoliosis surgery

2012-11-05T14:14:50Z

Culture and health care: Intergroup communication and its consequences

2012-01-10T22:42:30Z

Current diagnosis and management of mucopolysaccharidosis VI in the Asia-Pacific region

2012-08-20T14:42:07Z

Cyanoacrylate tissue adhesives - effective securement technique for intravascular catheters: in vitro testing of safety and feasibility

2012-06-25T00:00:00Z

Partial or complete dislodgement of intravascular catheters remains a significant problem in hospitals despite current securement methods. Cyanoacrylate tissue adhesives (TA) are currently used to close skin wounds as an alternative to sutures. These adhesives have high mechanical strength and can remain in situ for several days. This study investigated in vitro use of TAs in securing intravascular catheters (IVC). We compared two adhesives for interaction with IVC material, comparing skin glues with current securement methods in terms of their ability to prevent IVC dislodgement and to inhibit microbial growth. Two TAs (Dermabond® , Ethicon Inc. and Histoacryl® , B. Braun) and three removal agents (Remove™, paraffin and acetone) were tested for interaction with IVC material by use of tensile testing. TAs were also compared against two polyurethane (standard and bordered) dressings (Tegaderm™ 1624 and 1633, 3M Australia Pty Ltd) and an external stabilisation device (Statlock® , Bard Medical, Covington) against control (unsecured IVCs) for ability to prevent pull-out of 16 G peripheral IVCs from newborn fresh porcine skin. Agar media containing pH-sensitive dye was used to assess antimicrobial properties of TAs and polyurethane dressings to inhibit growth of Staphylococcus aureus and Staphylococcus epidermidis. Neither TA weakened the IVCs (P >0.05). Of removal agents, only acetone was associated with a significant decrease in IVC strength (P <0.05). Both TAs and Statlock significantly increased the pull-out force (P <0.01). TA was quick and easy to apply to IVCs, with no irritation or skin damage noted on removal and no bacterial colony growth under either TA.

Cytochrome c: Potential as a noninvasive biomarker of drug-induced acute kidney injury

Small, David M. og Gobe, Glenda C. — 2012-07-02T08:31:23Z

Acute kidney injury (AKI) in critically ill patients is closely associated with increased morbidity and mortality, yet there remains continued reliance on increased serum creatinine and blood urea nitrogen to diagnose AKI. These biomarkers increase only after significant renal structural damage has occurred. Recent research efforts have focused on discovery and validation of novel serum and urine biomarkers to detect AKI prior to extensive structural damage. Cytochrome c is best known as an indicator of cell death burden in any organ or tissue. It is released during mitochondrial damage that is associated with processing of apoptosis, cell lysis during necrosis and even reversible mitochondrial and cell injury. Areas covered: This article reviews the current literature on the potential for cytochrome c as an early biomarker of AKI. The article is based on PubMed searches, using the terms 'acute kidney injury,' 'renal failure,' 'biomarker,' 'toxicity' and 'cytochrome c', with a focus on experimental and clinical data. Expert opinion: Cytochrome c, as a biomarker, has the potential to improve outcome for AKI patients. Its release indicates mitochondrial damage, one of the earliest changes in cell injury and death. New mitochondrial-targeted therapeutics may be designed around this molecule. Its disadvantages include only transient increase at expression levels that are easily measurable and nonspecificity for kidney injury. The appropriate and optimal utilization of cytochrome c as a biomarker for AKI will be realized only after its complete characterization in experimental and clinical arenas.

Cytotoxic lymphocyte microRNAs as prospective biomarkers for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

2012-11-09T11:04:42Z

Daily Variation in Death in Patients Treated by Long-term Dialysis: Comparison of In-Center Hemodialysis to Peritoneal and Home Hemodialysis

2012-09-17T09:43:44Z

DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic

2012-12-17T16:52:48Z

Deaths reported from the accidental intrathecal administration of bortezomib

Gilbar, P. og Seger, A.C. — 2012-11-08T10:56:21Z

Deciding when to stop - towards evidence-based de-prescribing of drugs in older populations

2012-11-19T13:19:03Z

Decision influences and aftermath: Parents, stillbirth and autopsy

2012-08-02T00:32:58Z

Decision support methods for finding phenotype - disorder associations in the bone dysplasia domain

2012-12-06T16:16:20Z

A lack of mature domain knowledge and well established guidelines makes the medical diagnosis of skeletal dysplasias (a group of rare genetic disorders) a very complex process. Machine learning techniques can facilitate objective interpretation of medical observations for the purposes of decision support. However, building decision support models using such techniques is highly problematic in the context of rare genetic disorders, because it depends on access to mature domain knowledge. This paper describes an approach for developing a decision support model in medical domains that are underpinned by relatively sparse knowledge bases. We propose a solution that combines association rule mining with the Dempster-Shafer theory (DST) to compute probabilistic associations between sets of clinical features and disorders, which can then serve as support for medical decision making (e.g., diagnosis). We show, via experimental results, that our approach is able to provide meaningful outcomes even on small datasets with sparse distributions, in addition to outperforming other Machine Learning techniques and behaving slightly better than an initial diagnosis by a clinician.

Defining and evaluating success in paediatric cochlear implantation - an exploratory study

2012-11-04T00:07:19Z

Depression and sexual dysfunction in chronic kidney disease: a narrative review of the evidence in areas of significant unmet need

2012-10-21T00:12:16Z

People with chronic kidney disease (CKD) have a high symptom burden and experience poorer quality of life than the general population. People with CKD frequently report fatigue, anorexia, pain, sleep disturbance, itching and restless legs. Depression and sexual dysfunction may also be common in CKD, although questions about optimal diagnosis and treatment remain unanswered. People with kidney disease identify lifestyle and the impact of CKD on family and psychosocial supports as key priorities and rate symptoms such as sexual dysfunction and psychological distress as severe. Here, we outline the current state of research underlying depression and sexual dysfunction in this population focusing on prevalence, diagnosis, screening, outcomes and interventions and suggest areas requiring additional specific research.

Depressive symptoms in adolescents with early and continuously treated phenylketonuria: Associations with phenylalanine and tyrosine levels

2012-07-01T23:34:16Z

Dermatoscopy in routine practice 'Chaos and Clues'

2012-09-25T12:05:08Z

Dermatoscopy of facial actinic keratosis, intraepidermal carcinoma, and invasive squamous cell carcinoma: A progression model

2012-04-09T11:55:15Z

Dermoscopic and histopathologic correlations

2012-09-20T15:38:57Z

Dermoscopy is a widely diffused technique that offers the possibility to analyze subsurface structures not otherwise visible by naked eye. It has been proved that dermoscopy is an essential clinical tool in the hands of experts for diagnostic definition of melanocytic and non-melanocytic skin lesions, while improving diagnostic accuracy [1]. In addition to dermoscopy, reflectance-mode confocal microscopy (RCM) holds the great advantage to explore histological details of skin tissue, in vivo and in real time. Similarly to dermoscopy RCM produces images corresponding to horizontal section of the skin from the epidermis surface to the papillary dermis but offering a cellular level resolution, similarly to histopathology. Thus, it seems to be the natural link between dermoscopy and histopathology.

Dermoscopic features of amelanotic and hypomelanotic melanoma

Banan, Parastoo og Soyer, H. Peter — 2013-04-14T11:56:51Z

Melanomas that lack significant pigment are a diagnostic challenge. Dermoscopy, although less accurate for diagnosing these lesions than for pigmented lesions, is still superior to clinical examination.

Dermoscopy of scalp tumours: A multi-centre study conducted by the international dermoscopy society

2012-08-19T00:01:39Z

Dermoscopy of squamous cell carcinoma and keratoacanthoma

2013-01-13T00:22:07Z

Dermoscopy, reflectance confocal microscopy and histopathology of an amelanotic melanoma from an individual heterozygous for MC1R and tyrosinase variant alleles

2012-12-14T18:19:06Z

We present a case of an amelanotic nodular melanoma occurring in a 26-year-old woman who carried a heterozygous (melancortin-1-receptor) MC1R 160R/W and tyrosinase (TYR) 402R/Q genotype and had a dark hair phenotype. We present dermoscopic, reflectance confocal microscopy (RCM) and histopathological images of the melanoma. We discuss the relationship between MC1R red hair colour (RHC) variants, TYR variants, phenotype and melanoma development. We also discuss the merits of RCM as an additional diagnostic aid for equivocal melanocytic lesions.

Dermoscopy: The essentials

2011-11-24T00:00:00Z

Description and psychometric properties of the CP QOL-Teen: a quality of life questionnaire for adolescents with cerebral palsy

2013-02-10T00:33:07Z

To assess the measurement properties of a new QOL instrument, the Cerebral Palsy Quality of Life Questionnaire-Teen (CP QOL-Teen), in adolescents with cerebral palsy (CP) aged 13-18 years, examining domain structure, reliability, validity and adolescent-caregiver concordance. Based on age, 695 eligible families were invited to participate by mail. Questionnaires were returned by 112 primary caregivers (71.8% of questionnaires sent). 87 adolescents aged 12-18 years also completed the questionnaires. CP QOL-Teen, generic QOL instruments (KIDSCREEN, Pediatric Quality of Life Inventory), functioning (Gross Motor Function Classification System) and a condition-specific instrument (PedsQL-CP) were used. Principal components analysis produced seven scales: wellbeing and participation; communication and physical health; school wellbeing; social wellbeing; access to services; family health; feelings about functioning. Cronbach's alphas for the derived scales ranged from 0.81 to 0.96 (primary caregiver report) and 0.78 to 0.95 (adolescent report). Test-retest reliability (4 weeks) ranged from 0.57 to 0.88 for adolescent self-report and 0.29 to 0.83 for primary caregiver report. Moderate correlations were observed with other generic and condition specific measures of QOL, indicating adequate construct validity. Moderate correlations were observed between adolescent self-report and primary caregiver proxy report. This study demonstrates acceptable psychometric properties of both the adolescent self-report and the primary caregiver proxy report versions of the CP QOL-Teen.

Description, reliability and validity of a novel method to measure carpal tunnel pressure in patients with carpal tunnel syndrome

2012-12-30T00:10:06Z

Design and baseline characteristics of the 10 Small Steps Study: A randomised controlled trial of an intervention to promote healthy behaviour using a lifestyle score and personalised feedback

2012-03-22T12:11:51Z

Design and delivery of an e-learning curriculum for physicians involved in the management of pulmonary hypertension

2013-01-08T13:37:18Z

Designing and conducting randomized controlled trials in palliative care: a summary of discussions from the 2010 clinical research forum of the Australian Palliative Care Clinical Studies Collaborative

2012-12-23T00:26:36Z

Rigorous clinical research in palliative care is challenging but achievable. Trial participants are likely to have deteriorating performance status, co-morbidities and progressive disease. It is difficult to recruit patients, and attrition unrelated to the intervention being trialled is high. The aim of this paper is to highlight practical considerations from a forum held to discuss these issues by active palliative care clinical researchers.To date, the Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has randomized more than 500 participants across 12 sites in 8 Phase III studies. Insights from the 2010 clinical research forum of the PaCCSC are reported. All active Australian researchers in palliative care were invited to present their current research and address three specific questions: (1) What has worked well? (2) What didn't work well? and (3) How should the research be done differently next time?Fourteen studies were presented, including six double-blind, randomized, controlled, multi-site trials run by the PaCCSC. Key recommendations are reported, including guidance on design; methodologies; and strategies for maximizing recruitment and retention. These recommendations will help to inform future trial design and conduct in palliative care.