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.

Development of a Complex Intervention for Secondary Prevention of Coronary Heart Disease in Primary Care Using the UK Medical Research Council Framework

Objective: To apply the UK Medical Research Council (MRC) framework for development and evaluation of trials of complex interventions to a primary healthcare intervention to promote secondary prevention of coronary heart disease. Study Design: Case report of intervention development. Methods: First, literature relating to secondary prevention and lifestyle change was reviewed. Second, a preliminary intervention was modeled, based on literature findings and focus group interviews with patients (n = 23) and staff (n = 29) from 4 general practices. Participants’ experiences of and attitudes toward key intervention components were explored. Third, the preliminary intervention was pilot-tested in 4 general practices. After delivery of the pilot intervention, practitioners evaluated the training sessions, and qualitative data relating to experiences of the intervention were collected using semistructured interviews with staff (n = 10) and patient focus groups (n = 17). Results: Literature review identified 3 intervention components: a structured recall system, practitioner training, and patient information. Initial qualitative data identified variations in recall system design, training requirements (medication prescribing, facilitating behavior change), and information appropriate to the prospective study participants. Identifying detailed structures within intervention components clarified how the intervention could be tailored to individual practice, practitioner, and patient needs while preserving the theoretical functions of the components. Findings from the pilot phase informed further modeling of the intervention, reducing administrative time, increasing practical content of training, and omitting unhelpful patient information. Conclusion: Application of the MRC framework helped to determine the feasibility and development of a complex intervention for primary care research.

Design and Development of a Film-based Intervention about Teenage Men and Unintended Pregnancy: Applying the Medical Research Council Framework in Practice

Following the UK Medical Research Council’s (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys’ and girls’ intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: 1) know and engage the target population and engage gatekeepers in addressing contextual complexities; 2) know the targeted behaviours and model a process of change; and 3) look beyond development to evaluation and implementation.

Research in Progress: Medical Research Council United Kingdom Refractory Asthma Stratification Programme (RASP-UK)

The UK Refractory Asthma Stratification Programme(RASP-UK) will explore novel biomarker stratificationstrategies in severe asthma to improve clinicalmanagement and accelerate development of newtherapies. Prior asthma mechanistic studies have notstratified on inflammatory phenotype and theunderstanding of pathophysiological mechanisms inasthma without Type 2 cytokine inflammation is limited.RASP-UK will objectively assess adherence tocorticosteroids (CS) and examine a novel compositebiomarker strategy to optimise CS dose; this will alsoaddress what proportion of patients with severe asthmahave persistent symptoms without eosinophilic airwaysinflammation after progressive CS withdrawal. There will be interactive partnership with the pharmaceutical industry to facilitate access to stratified populations for novel therapeutic studies.

Anticholinergic medication use and cognitive impairment in the older population:the Medical Research Council cognitive function and ageing study

OBJECTIVES: To determine whether the use of medications with possible and definite anticholinergic activity increases the risk of cognitive impairment and mortality in older people and whether risk is cumulative. DESIGN: A 2-year longitudinal study of participants enrolled in the Medical Research Council Cognitive Function and Ageing Study between 1991 and 1993. SETTING: Community-dwelling and institutionalized participants. PARTICIPANTS: Thirteen thousand four participants aged 65 and older. MEASUREMENTS: Baseline use of possible or definite anticholinergics determined according to the Anticholinergic Cognitive Burden Scale and cognition determined using the Mini-Mental State Examination (MMSE). The main outcome measure was decline in the MMSE score at 2 years. RESULTS: At baseline, 47% of the population used a medication with possible anticholinergic properties, and 4% used a drug with definite anticholinergic properties. After adjusting for age, sex, educational level, social class, number of nonanticholinergic medications, number of comorbid health conditions, and cognitive performance at baseline, use of medication with definite anticholinergic effects was associated with a 0.33-point greater decline in MMSE score (95% confidence interval (CI)=0.03–0.64, P=.03) than not taking anticholinergics, whereas the use of possible anticholinergics at baseline was not associated with further decline (0.02, 95% CI=-0.14–0.11, P=.79). Two-year mortality was greater for those taking definite (OR=1.68; 95% CI=1.30–2.16; P<.001) and possible (OR=1.56; 95% CI=1.36–1.79; P<.001) anticholinergics. CONCLUSION: The use of medications with anticholinergic activity increases the cumulative risk of cognitive impairment and mortality.

National Agricultural Research Organisation. National Fisheries Resources Research Institute Annual Report 2011/2012

The annual report presents present activities and achievements for the reporting year 2011/2012. The Objectives of NaFIRRI are highlighted below: a) Generation of knowledge and technologies of strategic importance for the management, development and conservation of fisheries resources and water quality. b) Establishment and management of the human, physical and financial resources of the National Fisheries Resources Research Institute. c) Provision of technical backstopping and capacity building to the Ministry of Agriculture, Animal Industry and Fisheries (MAAIF), Zonal Agricultural Research and Development Institutes (ZARDIs) and other agencies dealing in fisheries research and water quality. d) Development and management of fisheries research information and ensuring collaboration with stakeholders. e) Planning, monitoring and evaluation of all fisheries research programmes undertaken by the institute to ensure conformity with national research strategy. f) Ensuring the quality of knowledge and technologies developed, multiplied and disseminated through uptake pathways. g) Generation of periodic reports on fisheries and water quality research programmes to National Agricultural Research Council (NARC) and other stakeholders. h) Establishment of sustainable linkages and partnerships with local, regional and international research bodies.

Addressing migration-related social and health inequalities in Australia: call for research funding priorities to recognise the needs of migrant populations

Objective Migrants constitute 26% of the total Australian population and, although disproportionately affected by chronic diseases, they are under-represented in health research. The aim of the present study was to describe trends in Australian Research Council (ARC)- and National Health and Medical Research Council (NHMRC)-funded initiatives from 2002 to 2011 with a key focus on migration-related research funding.Methods Data on all NHMRC- and ARC-funded initiatives between 2002 and 2011 were collected from the research funding statistics and national competitive grants program data systems, respectively. The research funding expenditures within these two schemes were categorised into two major groups: (1) people focused (migrant-related and mainstream-related); and (2) basic science focused. Descriptive statistics were used to summarise the data and report the trends in NHMRC and ARC funding over the 10-year period.Results Over 10 years, the ARC funded 15 354 initiatives worth A$5.5 billion, with 897 (5.8%) people-focused projects funded, worth A$254.4 million. Migrant-related research constituted 7.8% of all people-focused research. The NHMRC funded 12 399 initiatives worth A$5.6 billion, with 447 (3.6%) people-focused projects funded, worth A$207.2 million. Migrant-related research accounted for 6.2% of all people-focused initiatives.Conclusions Although migrant groups are disproportionately affected by social and health inequalities, the findings of the present study show that migrant-related research is inadequately funded compared with mainstream-related research. Unless equitable research funding is achieved, it will be impossible to build a strong evidence base for planning effective measures to reduce these inequalities among migrants.What is known about the topic? Immigration is on the rise in most developing countries, including Australia, and most migrants come from low- and middle-income countries. In Australia, migrants constitute 26% of the total Australian population and include refugee and asylum seeker population groups. Migrants are disproportionately affected by disease, yet they have been found to be under-represented in health research and public health interventions.What does this paper add? This paper highlights the disproportions in research funding for research among migrants. Despite migrants being disproportionately affected by disease burden, research into their health conditions and risk factors is grossly underfunded compared with the mainstream population.What are the implications for practitioners? Migrants represent a significant proportion of the Australian population and hence are capable of incurring high costs to the Australian health system. There are two major implications for practitioners. First, the migrant population is constantly growing, therefore integrating the needs of migrants into the development of health policy is important in ensuring equity across health service delivery and utilisation in Australia. Second, the health needs of migrants will only be uncovered when a clear picture of their true health status and other determinants of health, such as psychological, economic, social and cultural, are identified through empirical research studies. Unless equitable research funding is achieved, it will be impossible to build a strong evidence base for planning effective measures to reduce health and social inequalities among migrant communities.

Multicenter Analysis of Glucocerebrosidase Mutations in Parkinson`s Disease

Background Recent studies indicate an increased frequency of mutations in the gene encoding glucocerebrosidase (GBA), a deficiency of which causes Gaucher`s disease, among patients with Parkinson`s disease. We aimed to ascertain the frequency of GBA mutations in an ethnically diverse group of patients with Parkinson`s disease. Methods Sixteen centers participated in our international, collaborative study: five from the Americas, six from Europe, two from Israel, and three from Asia. Each center genotyped a standard DNA panel to permit comparison of the genotyping results across centers. Genotypes and phenotypic data from a total of 5691 patients with Parkinson`s disease (780 Ashkenazi Jews) and 4898 controls (387 Ashkenazi Jews) were analyzed, with multivariate logistic-regression models and the Mantel-Haenszel procedure used to estimate odds ratios across centers. Results All 16 centers could detect two GBA mutations, L444P and N370S. Among Ashkenazi Jewish subjects, either mutation was found in 15% of patients and 3% of controls, and among non-Ashkenazi Jewish subjects, either mutation was found in 3% of patients and less than 1% of controls. GBA was fully sequenced for 1883 non-Ashkenazi Jewish patients, and mutations were identified in 7%, showing that limited mutation screening can miss half the mutant alleles. The odds ratio for any GBA mutation in patients versus controls was 5.43 across centers. As compared with patients who did not carry a GBA mutation, those with a GBA mutation presented earlier with the disease, were more likely to have affected relatives, and were more likely to have atypical clinical manifestations. Conclusions Data collected from 16 centers demonstrate that there is a strong association between GBA mutations and Parkinson`s disease.

National Research Council of Thailand Visit

Agenda for the National Research Council of Thailand's Visit to Florida International University on May 17 and 18, 2007.

[Ressenya del llibre Rediscovering geography: new relevance for science and society, de Rediscovering Geography Committee, National Research Council]

El llibre ressenyat pretén ser una síntesi i una avaluació de la situació de la geografia als Estats Units. Estructurat en vuit capítols, els sis primers són una anàlisi de diversos aspectes de la geografia i els dos últims expliquen quina estratègia hauria de portar-se a terme per enfortir el paper de la geografia en el món acadèmic i en la societat en general

... Algebraic numbers. Report of the Committee on Algebraic Numbers, National Research Council,

Cover-title.