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O'Rourke N.,Cochrane Lung Cancer Group | Macbeth F.,National Institute for Health and Clinical Excellence
Clinical Oncology | Year: 2010

In the past 15 years, the treatment of locally advanced non-small cell lung cancer (NSCLC) has shifted from radiotherapy alone. There are now schedules using induction chemotherapy, concurrent chemoradiation using either radiosensitising doses of chemotherapy or full-dose chemotherapy, consolidation chemotherapy after radiation or combinations of these options. There is no consensus on the optimal chemotherapy regimen and its scheduling and the issue of radiation dose and optimal fractionation equally remains unresolved. This overview is in two sections. First, we have evaluated a selection of international guidelines on the management of locally advanced NSCLC. We assessed the methodology by which individual guidelines were produced and the levels of evidence quoted in support of the recommendations. Second, we have updated the literature search of the 2004 Cochrane review on concurrent chemoradiation. Trials were identified that compared sequential with concurrent chemoradiation using median survival as the primary outcome measure. Two-year survival and toxicity were evaluated as secondary outcome measures. Eleven trials were identified, of which six fulfilled criteria for inclusion. The median survival for concurrent treatment was 16-17 months compared with 13-15 months with sequential treatment. Treatment-related mortality was 3% for concurrent treatment and 1.7% for sequential treatment. The rate of grade 3 or worse oesophagitis was 19% in concurrent treatment compared with 3% for sequential treatment. In conclusion, chemotherapy adds benefit to radiotherapy treatment of locally advanced NSCLC. Concurrent chemoradiation is associated with significant toxicity. The evidence to support concurrent chemoradiation as the standard of care is not robust, in spite of its recommendation within a number of guidelines. Further trials should be supported. © 2010 The Royal College of Radiologists. Source


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.3.2-2 | Award Amount: 4.04M | Year: 2013

The use of HTA has increased recently in Europe and more widely (e.g. Americas) to enable evidence-based coverage decisions and improve efficiency in resource allocation. HTA has often resulted in different coverage decisions across settings despite the same evidence being used for this purpose. This may reflect in part societal preferences about value, priorities or risk perceptions, suggesting a significant need for methodological improvements and extensions. The fundamental objective of ADVANCE_HTA is to contribute to advancements in the methods for HTA in European and other settings by involving the wider stakeholder community in areas actively and heavily debated given their implications for decision-making and resource allocation, as follows: First, the issue around value for money and the different approaches surrounding current thresholds for resource allocation; Second, the concept of value assessment, and the factors that need to be considered beyond cost effectiveness, such as disease severity; Third, to improve the quality of the evidence required for and the methods associated with the assessment of rare diseases; Fourth, to advance the debate in the elicitation of preferences by deriving these in more realistic settings within the patient community in the wider EU; Fifth, to advance the debate on the suitability of current HTA tools across different categories of medical devices (e.g. diagnostics); and Sixth, to improve the implementation and capacity building of HTA including outside Europe, where HTA is considered explicitly in decision-making. ADVANCE_HTA aims to broaden the spectrum, complement and address areas of intense methodological debate in the application, use and implementation of HTA. It also aims to improve HTA methods, which can be taken further by competent authorities nationally whilst supplementing the work of supra-national bodies (e.g. EUnetHTA) towards a common understanding of choices in health care decision-making.


Qaseem A.,The American College | Forland F.,KIT Biomedical Research | Macbeth F.,National Institute for Health and Clinical Excellence | Ollenschlager G.,Arztliches Zentrum fur Qualitat in der Medizin | And 2 more authors.
Annals of Internal Medicine | Year: 2012

Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development. Source


Kakkar A.K.,Queen Mary, University of London | MacBeth F.,National Institute for Health and Clinical Excellence
British Journal of Cancer | Year: 2010

A broad range of studies suggest a two-way relationship between cancer and venous thromboembolism (VTE). Patients with cancer have consistently been shown to be at elevated risk for VTE; this risk is partly driven by an intrinsic hypercoagulable state elicited by the tumour itself. Conversely, thromboembolic events in patients without obvious risk factors are often the first clinical manifestation of an undiagnosed malignancy. The relationship between VTE and cancer is further supported by a number of trials and meta-analyses which, when taken together, strongly suggest that antithrombotic therapy can extend survival in patients with cancer by a mechanism that extends beyond its effect in preventing VTE. Moreover, accumulating evidence from in vitro and in vivo studies has shown that tumour growth, invasion, and metastasis are governed, in part, by elements of the coagulation system. On 22 May 2009, a group of health-care providers based in the United Kingdom met in London, England, to examine recent advances in cancer-associated thrombosis and its implications for UK clinical practice. As part of the discussion, attendees evaluated evidence for and against an effect of antithrombotic therapy on survival in cancer. This paper includes a summary of the data presented at the meeting and explores potential mechanisms by which antithrombotic agents might exert antitumour effects. The summary is followed by a consensus statement developed by the group. © 2010 Cancer Research UK. All rights reserved. Source


Rawlins M.D.,National Institute for Health and Clinical Excellence
British Journal of Clinical Pharmacology | Year: 2012

The fourth hurdle, the requirement that pharmaceutical manufacturers can demonstrate that their new products represent good value for money as well as being of good quality, effective and safe, is increasingly being required by healthcare systems. In crossing this 'fourth' hurdle, companies will usually need to demonstrate that their products are more effective than relevant comparators and that the increased cost is offset by the enhanced benefits. Decision makers, however, must draw their conclusions not only on the basis of the underpinning science but also on the social values of the people they serve. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society. Source

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