Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - (Page 8) EVIDENCE AND EFFECTIVENESS prevention of ischemic cardiopathy estimate that up to 69% of patients in some countries do not achieve the objectives of risk-factor control. Against this background, healthcare experts are increasingly emphasizing the importance of identifying obstacles to change, with a view to developing more effective strategies for implementation. A number of studies have attempted to understand the barriers impeding the incorporation of evidence in clinical practice. Among those identified are: ● lack of knowledge about the evidence ● absence of the doctor’s consent ● low expectation of achieving optimal results ● inertia of previous practices ● over-worked surgeries ● lack of time ● shortage of adequate reminder systems. the heterogeneity of the compiled studies does not appear to be an a priori impediment, and that it is necessary to be particularly detailed in describing the methods and findings. At the same time, the results obtained from effectiveness studies should not be magnified to the detriment of the efficacy studies. Both approaches are necessary and complementary. A balance between both types gives results that are not overestimated by possible confounding factors or bias and which are representative of the patients who attend surgeries. Pragmatic clinical trials would respond well to these premises but are regrettably few and far between, perhaps because of their difficult methodology and because of greater familiarity with and a better understanding of traditional RCTs. New models For this reason, we must go beyond the EBM paradigm and promote other types of models. Starting with ideal evidence, obtained in RCTs, we should understand patient preferences and also take into account how far we can go in daily clinical practice. Some interesting initiatives are already attempting to incorporate patients into the process of elaborating CPGs. These include the Scottish Intercollegiate Guideline Network (SIGN), a body that develops and publishes evidencebased CPGs to improve the effectiveness and efficiency of clinical care. For a number of years it has counted patients, carers and the public among its working groups. Nevertheless, the perspective of real clinical practice in CPGs is still missing. The huge disparity between the quantity of information on efficacy and the paucity of information on effectiveness is a testament to this. Reducing the gap Various options can be explored for reducing the gap and moving from medicine based on evidence to medicine based on effectiveness or other quality comparison in the evidence, placing it on the same level as that furnished by observational and experimental studies. Classically, it is said that observational studies — where inferences are drawn or hypotheses tested through observation — may bias results and overestimate the effect of a treatment or action, but nowadays we have the means of comparing both types of studies. Their results are unambiguous: they do not reveal any data supporting the concept that observational studies magnify treatments; indeed some of the results are more precise, with a smaller credibility gap. The solution is to design sound observational studies whose internal validity is not compromised by their representative nature or external validity. The MOOSE proposal, which sets out criteria for the effective reporting of meta-analysis in observational studies,1 is a good initiative for raising the quality of meta-analyses of observational studies, taking into consideration that the confounding variables are going to be inevitable in many cases, that 8 Another possibility would be to include groups of independent doctors in the drafting of CPGs, who would reach a consensus on the minimum control objectives that are viable in clinical practice, or more information on effectiveness — on what happens in real-life situations. By understanding the reality on the ground, in surgeries that are similar to theirs, doctors can gain a better insight into what they can expect and what they should propose to patients. Furthermore, it is important to keep in mind that the RCTs are designed to answer questions on efficacy and safety and in order to avoid bias they require a very structured therapy regimen and intensive monitoring and follow-through so as to isolate the effects of the new treatment from other possible bias. In the case of pharmacoeconomic analyses, as well as other types of more pragmatic designs, it is necessary to have studies that give greater attention to generalisation and external validity. RCTs and effectiveness studies provide complementary information on the impact of treatments on patients and on the variables in the results obtained in the health system. Notwithstanding this, to date there has been plentiful information on the former and very little on the latter. Only by targeting research on areas of shortfall and re-adjusting the gradation of the evidence, taking into account what will be done in real clinical practice and not in an ideal world, will we be able to reduce the gap. ■ Reference 1. D. F. Stroup et al. “Meta analysis of observational studies in epidemiology: A proposal for reporting,” JAMA, 2000; 283(15): 2008–12. About the Author Xavier Badía is principal, Health Economics and Outcomes Research, at IMS Health, with particular expertise in outcomes research, patient-reported outcomes, effectiveness and cost-effectiveness evaluations. An accomplished university lecturer and member of several international advisory boards, Xavier has published more than 150 papers in peer-reviewed journals and serves on the editorial committees of various international health economics publications. DECEMBER 2007 HEALTH ECONOMICS
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 Contents Budget Impact Analyses: BIAs: The Fifth Hurdle? Evidence and Effectiveness: Redressing the Balance Commercializing HEOR: Adding Value Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 (Page 1) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 (Page 2) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Contents (Page 3) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Budget Impact Analyses: BIAs: The Fifth Hurdle? (Page 4) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Budget Impact Analyses: BIAs: The Fifth Hurdle? (Page 5) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Budget Impact Analyses: BIAs: The Fifth Hurdle? (Page 6) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Evidence and Effectiveness: Redressing the Balance (Page 7) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Evidence and Effectiveness: Redressing the Balance (Page 8) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Commercializing HEOR: Adding Value (Page 9) Pharmaceutical Executive Europe IMS Health Economics Supplement - December 2007 - Commercializing HEOR: Adding Value (Page 10)
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