Multi-centre research in Australia:analysis of a recent National Health and Medical Research Council-funded project

BACKGROUND AND OBJECTIVE: Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world.

METHODS: This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008.

RESULTS: Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143.

CONCLUSIONS: Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.

Availability of complementary and alternative medicine for people with cancer in the British National Health Service: Results of a national survey

This study assessed access to Complementary and Alternative Medicine (CAM) therapies for people with cancer within the British National Health Service. CAM units were identified through an internet search in 2009. A total of 142 units, providing 62 different therapies, were identified: 105 (74.0%) England; 23 (16.2%) Scotland; 7 (4.9%) each in Wales and Northern Ireland. Most units provide a small number of therapies (median 4, range 1–20), and focus on complementary, rather than alternative approaches. Counselling is the most widely provided therapy (available at 82.4% of identified units), followed by reflexology (62.0%), aromatherapy (59.1%), reiki (43.0%), massage (42.2%). CAM units per million of the population varied between countries (England: 2.2; Wales: 2.3; Scotland: 4.8; Northern Ireland: 5.0), and within countries. Better publicity for CAM units, greater integration of units in conventional cancer treatment centres may help improve access to CAMs.

Chronic kidney disease and diabetes in the National Health Service:a cross-sectional survey of the UK National Diabetes Audit

We investigated the prevalence of chronic kidney disease and attainment of therapeutic targets for HbA1c and blood pressure in a large UK-based diabetes population.

Sexual Health and Sexuality Education Needs of Young People in Care: a Survey of Service-provider Perspectives. Report No 1.

Aim: This study aims to describe the sex education and sexual health needs of young people in care, and to explore the degree to which these needs are being met by current provision.As part of the Department for Children and Youth Affairs ‘National Strategy for Data and Research on Children’s Lives, 2011-2016’, the HSE Crisis Pregnancy Programme (CPP) and HSE Children and Families Social Services Care Group have co-commissioned a team of researchers from UCD School of Nursing, Midwifery & Health Systems, Insights Health and Social Research and Queen’s University Belfast to examine the sex education and sexual health needs of young people in care in the Republic of Ireland. The project is supported by a steering group of senior personnel from both partner organisations (CPP and CFS) and external advisors. The study involves data collection with young people, care providers, birth parents and foster parents using a mixed methods approach. Findings from each stage of the study will be combined to inform recommendations for policy and practice.

Urinary deoxynivalenol is correlated with cereal intake in individuals from the United Kingdom

BACKGROUND: Deoxynivalenol (DON) is a toxic fungal metabolite that frequently contaminates cereal crops. DON is toxic to animals, but the effects on humans are poorly understood, in part because exposure estimates are of limited precision.

OBJECTIVES: In this study we used the U.K. adult National Diet and Nutrition Survey to compare 24-hr urinary DON excretion with cereal intake.

METHODS: One hundred subjects were identified for each of the following cereal consumption groups: low (mean, 107 g cereal/day; range, 88-125), medium (mean, 179 g/day; range, 162-195) and high (mean, 300 g/day, range, 276-325). DON was analyzed in 24-hr urine samples by liquid chromatography mass spectrometry after purification on immunoaffinity columns.

RESULTS: DON was detected in 296 of 300 (98.7%) urine samples. Cereal intake was significantly associated with urinary DON (P < 0.0005), with the geometric mean urinary levels being 6.55 mu g DON/day [95% confidence interval (CI), 5.71-7-531; 9.63 mu g/day (95% Cl, 8.39-11.05); and 13.24 mu g/day (95% Cl, 11.54-15.19) for low-, medium-, and high-intake groups, respectively. In multivariable analysis, wholemeal bread (p < 0.0005), white bread (p < 0.0005), "other" bread (p < 0.0005), buns/cakes (p = 0.003), high-fiber breakfast cereal (p = 0.016), and pasta (p = 0.017) were significantly associated with urinary DON. Wholemeal bread was associated with the greatest percent increase in urinary DON per unit of consumption, but white bread contributed approximately twice as much as wholemeal bread to the urinary DON levels because it was consumed in higher amounts.

CONCLUSION: The majority of adults in the United Kingdom appear to be exposed to DON, and on the basis of the urinary levels, we estimate that some individuals may exceed the European Union (EU) recommended maximum tolerable daily intake of 1,000 ng DON/kg (bw). This exposure biomarker will be a valuable toot for biomonitoring as part of surveillance strategies and in etiologic studies of DON and human disease risk.

Management of Hyperphosphataemia in Chronic Kidney Disease:Summary of National Institute for Health and Clinical Excellence (NICE) Guideline

Bone disease and ectopic calcification are the two main consequences of hyperphosphataemia of chronic kidney disease (CKD). Observational studies have demonstrated that hyperphosphataemia in CKD is associated with increased mortality. Furthermore, the use of phosphate binders in dialysis patients is associated with significantly lower mortality. The UK Renal Registry data show significant underachievement of phosphate targets in dialysis patients. It is believed to be due to wide variation in how management interventions are used. The National Institute for Health and Clinical Excellence (NICE) has developed a guideline on the management of hyperphosphataemia in CKD. This is based on the evidence currently available using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. This review outlines the recommendations including research recommendations and discusses methodology, rationale and challenges faced in developing this guideline and the health economic model used to assess the cost-effectiveness of different phosphate binders. © 2013 S. Karger AG, Basel.