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• W2767968586 abstract "We were very interested to read the economic evaluation of human menopausal gonadotropin (hMG) versus recombinant human follicle-stimulating hormone (rhFSH) by Lloyd et al. (1Lloyd A. Kennedy R. Hutchinson J. Sawyer W. Economic evaluation of highly purified menotropin compared with recombinant follicle-stimulating hormone in assisted reproduction.Fertil Steril. 2003; 80: 1108-1113Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). This article contains a number of important inconsistencies, which make its conclusions scientifically invalid for the following reasons. The lack of any statistically significant difference in pregnancy rates between the two treatments (hMG and rhFSH) in the clinical study on which the evaluation was based (2European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating HormoneEfficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles a randomized, comparative trial.Fertil Steril. 2002; 78: 520-528Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar) should not be considered as evidence of equivalence. The only valid conclusion is that the power of the trial was not sufficient to establish a difference. Cost-minimization analysis assumes that outputs (in this case, pregnancy rates) are equal (3Kernick D.P. Economic evaluation in health a thumb nail sketch.BMJ. 1998; 316: 1663-1665Crossref PubMed Scopus (17) Google Scholar). It is therefore flawed to base any “economic analysis” on the unproven assumption of equivalence. When the authors explained their calculations, they mentioned using “simple economic modeling techniques.” Where is the model? There is no information anywhere in the article to indicate which kind of model the authors are talking about! The authors' calculation of medical resources features a number of inaccuracies. For example, the cost of other drugs is described as “various,” the cost of adverse events is not clearly stated, and the cost of potential complications (e.g., ovarian hyperstimulation syndrome) is not even mentioned. To help clinicians understand the potential validity of published economic articles, we are happy to propose some simple guidelines: A “model” implies that a mathematical formula has been generated to link several variables. It is critical to look at the type of model used, what variables are included, and what is generated by the model. A “nondifference” is not an equivalence, and a “nonequivalence” is not a difference. Most patients need to follow more than one treatment cycle, so the analysis must take into account more than one cycle. Because a significant number of patients use frozen embryos, the analysis must evaluate efficacy and the cost of frozen cycles. Costs of side effects and complications must be considered. No great skill in economic evaluation is necessary to understand and use these guidelines. Based on these guidelines, the article by Lloyd et al. (1Lloyd A. Kennedy R. Hutchinson J. Sawyer W. Economic evaluation of highly purified menotropin compared with recombinant follicle-stimulating hormone in assisted reproduction.Fertil Steril. 2003; 80: 1108-1113Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar) clearly is flawed and its conclusions are questionable." @default.
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• W2767968586 date "2004-05-01" @default.
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• W2767968586 title "Clinically relevant differences and “biocreep”" @default.
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• W2767968586 doi "https://doi.org/10.1016/j.fertnstert.2004.03.001" @default.
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