Δευτέρα 26 Φεβρουαρίου 2018

Response

We thank Cherny and colleagues for their comments about our article. Our use of the term "arbitrary" to describe the cutoffs utilized in the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) was not meant to reflect a criticism of the development of this tool. It was simply an observation that the assessments of value in health care (which in the case of ESMO-MCBS is based on both efficacy and safety) are continuous measures that exist over a spectrum. Typically, attempts to dichotomize a continuous variable are subject to some arbitrary decisions. This is supported by data that show that there is only fair correlation between the assessment of value by ESMO-MCBS and other value frameworks despite the use of the same constructs of clinical benefit (1–3). Additionally, we are familiar with the robust statistical modeling that was performed to develop the ESMO-MCBS (4). However, even with this modeling, arbitrary cutoffs were utilized. For example, the decision to base efficacy assessment on the lower limit of the 95% confidence interval for the hazard ratio may be based on long-standing statistical dogma, but it is a somewhat arbitrary cutoff.

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