http://www.iiss.es/gcs/
Hochman M, McCormick D
Characteristics of Published Comparative Effectiveness Studies of Medications. JAMA. 2010, 303:951-8.
Objective To analyze the characteristics of comparative effectiveness studies recently published in journals with high impact factor. Data and method
Systematic review of randomized clinical trials, case-control studies, cohort studies and meta-analysis published in 6 medical journals with higher impact factor (New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, BMJ and Archives of Internal Medicine) from June 2008 to September 2009. Were defined as those comparative effectiveness studies comparing an existing drug therapies against active (active comparator studies) rather than active therapy compared with inactive placebo control. Results
104 of 328 (31.7%) identified studies presented results of comparative effectiveness. Of these, 43% compared different prescription drugs and 11 non-pharmacological interventions. Comparative effectiveness studies were less likely than the rest to be financed privately only (87% of the studies were funded by nonprofit sources, 63% public funding). Only 2 of the 104 selected studies presented cost-effectiveness ratios. Between trials, the probability of statistically significant results in favor of the intervention being tested is significantly lower in the comparative effectiveness studies (39% vs. 63% in other studies). 24% of randomized clinical trials used active comparators aim to demonstrate non-inferiority. Conclusions
Only a third of the studies published in magazines "top" provides evidence of effectiveness compared, which are very rare compared with non-drug alternatives, or that safety or cost analysis. Funding is mostly by public and nonprofit organizations.
Funding: None stated; Conflict of interest: none declared; Correspondence: mhochman@usc.edu
comment on the comparative effectiveness or the extent to which an intervention contributes to improved health status for one or more alternative interventions (1). This is a concept similar to added therapeutic value (2), essential from the standpoint of the social value of innovations and a previous input, and essential for estimating the cost-effectiveness ratios (incremental cost per incremental unit of output is achieved with the intervention evaluated against their comparators).
The focus of the incremental cost-effectiveness is appropriate to the decisions of a certain treatment coverage by public insurance, the price you are willing to pay for it, and the clinical situations and patient groups in which recommended (ie, the formularies, software recommendations, and indicator systems prescription or not associated with incentives).
The measure of comparative effectiveness (achieving or not the estimated cost-effectiveness ratios) is a key factor in financing decisions taken by insurers to be efficient and help to maximize health improvement. Away from the unfortunate translation of the concepts of comparative effectiveness and cost-effectiveness ratio as a fourth barrier (after the "barriers" regulatory efficiency, safety and quality), research on the measurement of these concepts is the essential guarantee for the maximization of health objectives in the presence of financial constraints. Additionally, use this fourth "guarantee" in making decisions through independent agencies and committees of experts is able to defend the value of efficient and effective innovation policy "blind" to contain costs and ensure that limited resources available for health systems are intended to treatments are worth their cost (3).
The review published by Hochman and McCormick has a positive reading (almost a third of the studies published by the 6 major journals relating to similar effect) but also should serve to bring out the debate on the conditions of implementation and funding these studies. The measure of comparative effectiveness studies require less non-inferiority and superiority over studies, requiring more complex trials with more patients and more expensive. If the major regulatory authorities hold the attention away from the comparative effectiveness is issued a clear signal for the development of innovations in low value added and allowed therapeutic comparative effectiveness in the field of negotiation with donors. If you keep the status quo, innovators have little incentive to develop comparative effectiveness studies of high methodological quality and the production of this information will require government intervention or non-profit, especially when there is uncertainty about the efficacy / effectiveness innovation.
The example of the United Kingdom, Australia and Canada in the use of comparative effectiveness and cost-effectiveness ratio coverage decisions not only provides evidence that it is feasible for use in these decisions but they have encouraged the production of information Comparative efficacy by the market (4).
1. Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S. Relative Efficacy of drugs: an Emerging Issues Between Regulatory Agencies and third-party Payers. Nature Reviews. 2010, 9:277-91.
2. Junoy Puig J, Peiró S. The usefulness of drugs added therapeutic value and cost-effectiveness. En Rev Public Health. 2009, 83: 59-70.
3. Mushlin AI, Ghomrawi H. Health Care Reform and the Need for Comparative-Effectiveness Research. N Engl J Med 2010; 362 (3): e6.
4. FM Clement, Harris A, Li JJ, Yong K, Lee KL, Manns BJ. Using Effectiveness and Cost-Effectiveness Decisions to Make Drug Coverage. JAMA, 302:1437-43.
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