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Systematic reviews (SR) are an evidence synthesis approach that provides robust and transparent answers toclearly formulated questions. Originally developed for use in clinical practice, SRs have wider applicability,including food and feed safety risk assessment. EFSA has implemented the use of SRs, and this documentcontributes to the further development of this in-house capacity. Since the publication of the document"Application of Systematic Review Methodology to Food and Feed Safety Assessments to Support DecisionMaking", which mainly focuses on interventions and exposures (PECO/PICO), little has changed in this arena.Fast increasing fields of application include chemical and environmental risk assessment, and analysingenvironmental management interventions. Considering time constraints at EFSA, the use of SRs should bepursued thoughtfully. Important are the use of explicit systematic methods aimed at minimising bias andmaximising transparency in order to produce the most reliable findings that can be used to inform decisionmaking. Participants of the training courses indicated SRs should be a priority for controversial topics (whichmight be subject to greater scrutiny by external parties, including the public, and thereby would benefit frommaximum transparency) or topics for which there was disagreement amongst experts. Some areas addressed byEFSA have considerable potential impact, for example related to public health or animal trade, and these topicscould be prioritised for SR. Under severe time constraints, a full SR may not be possible, but a rapid review canbe considered. However rapid reviews are not a substitute for systematic reviews. Adoption of rapid reviewsexchanges one set of concerns (time and resources contracts) for another (lack of robustness andcomprehensiveness). In the view of the Consortium, the continuation of training opportunities is important.Appropriate commissioning of SR expertise is an important step in establishing the role of the methodology in EFSA risk assessments.
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INTRODUCTION: Adding pioglitazone or rosiglitazone to existing therapy are alternative treatment options for patients with type 2 diabetes mellitus who have insufficient glycaemic control while receiving the maximal tolerated dose of metformin monotherapy. Our objective was to develop a lifetime model of type 2 diabetes mellitus and its sequelae in order to compare the costs and benefits of pioglitazone versus rosiglitazone in combination with metformin.
METHODS: A decision-analytic model employing a first order Monte Carlo simulation of a Markov process was constructed. The model incorporated surrogate outcome measures from a large randomised controlled trial (RCT) [n = 802] that compared the glycaemic and lipid control of pioglitazone and rosiglitazone monotherapy. These efficacy data were used with a recently validated and peer-reviewed UKPDS (UK Prospective Diabetes Study) algorithm to simulate the progression of these surrogate outcomes to final health outcomes, including quality of life (QOL) and mortality, and to calculate the risks of diabetic complications and death. The model perspective was of the UK NHS and included direct healthcare costs only (pounds, 2004/5 values). Patient outcomes measured in the model included life-expectancy (LE) and QALYs. The base-case analysis was run for 56-year-old male Caucasions with a haemoglobin A(1c) (HbA(1c)) of 7.57% and a body mass index of 33.14 kg/m(2).
RESULTS: Patients treated with pioglitazone experienced a reduction in the total cholesterol to high-density lipoprotein-cholesterol (TC : HDL-C) ratio of 0.34, whereas the TC : HDL-C ratio increased by 0.65 in those receiving rosiglitazone (p < 0.001). The HbA(1c) profile was similar between the treatment groups (p = 0.13), as were other known risk factors for diabetes complications. The lifetime healthcare costs per patient estimated by the model were 9585 pounds for pioglitazone and 10,299 pounds for rosiglitazone. Patients treated with pioglitazone had a discounted LE of 8.83 years versus 8.79 years for those treated with rosiglitazone. Patients treated with pioglitazone also gained additional QALYs (6.8070 vs 6.7686). With improved health outcomes and lower costs, treatment with pioglitazone dominated rosiglitazone treatment. CONCLUSION: Evidence from the only large head-to-head RCT comparing rosiglitazone and pioglitazone suggests that more favourable changes in serum lipid profiles in patients treated with pioglitazone translate into improved health outcomes in terms of reduced morbidity and mortality and greater gains in QOL. In addition, this analysis indicates that treatment with pioglitazone is associated with lower costs than rosiglitazone. Therefore, in the UK, adjunctive pioglitazone may represent a cost-effective treatment choice for patients with type 2 diabetes who have insufficient glycaemic control while receiving the maximal tolerated dose of metformin monotherapy.
Improving health through better nutrition of the population may contribute to enhanced efficiency and sustainability of healthcare systems. A recent expert meeting investigated in detail a number of methodological aspects related to the discipline of nutrition economics. The role of nutrition in health maintenance and in the prevention of non-communicable diseases is now generally recognised. However, the main scope of those seeking to contain healthcare expenditures tends to focus on the management of existing chronic diseases. Identifying additional relevant dimensions to measure and the context of use will become increasingly important in selecting and developing outcome measurements for nutrition interventions. The translation of nutrition-related research data into public health guidance raises the challenging issue of carrying out more pragmatic trials in many areas where these would generate the most useful evidence for health policy decision-making. Nutrition exemplifies all the types of interventions and policy which need evaluating across the health field. There is a need to start actively engaging key stakeholders in order to collect data and to widen health technology assessment approaches for achieving a policy shift from evidence-based medicine to evidence-based decision-making in the field of nutrition.
Citizen preferences surrounding desirable health system characteristics should be considered when undertaking health system reform. The objective of this study was to pilot test a discrete-choice instrument designed to elicit preference weights surrounding health system attributes.
A discrete-choice experiment was designed and administered to two convenience samples (n=50 each) recruited from the UK and Australia. The impact of eight health system attributes representing level of health, equity, responsiveness and healthcare financing on the choice between hypothetical health systems was analysed utilizing mixed logit analysis.
All characteristics affected the likelihood a health system would be preferred, with the exception of the additional tax contribution levels required to finance the system. There were very few missing or inconsistent responses. The direction of preferences was consistent with expectations for both samples; that is, an improvement in attributes describing level of health, equity or responsiveness increased the likelihood that a health system would be preferred.
A number of potential improvements to the preference instrument are suggested. The discrete-choice technique used in this study offers a feasible method for eliciting health system preferences, and its use in a larger-scale study to elicit and compare the preferences of representative population samples is supported.
