In Reply In response to the query by Dr Douma and colleagues regarding the HR of 0.83 reported in the multivariable analysis of overall survival, the clinical meaningfulness bar of an HR of 0.8 suggested by working groups of the ASCO Cancer Research Committee is intended for application to a different context, namely clinical trials of costly and toxic antineoplastic therapies.1 Although there is some cost associated with infrastructure and staffing for an online symptom-reporting intervention, the intervention itself is nontoxic and reduces rather than increases resource utilization (ie, leads to reduced emergency department visits). In this context, we think that the observed increase in overall survival is clinically meaningful, an assertion further supported by Sobrero and colleagues2 who noted that a benefit of the magnitude observed in our trial is clinically meaningful if cost and toxicity are moderate. Moreover, the intervention was associated with a clinically meaningful and significant gain in health-related quality of life,3 which we believe independently substantiates its value to patients. Based on these findings, criteria in the ASCO Value Framework would classify this intervention favorably.4
Basch E, Deal AM, Dueck AC. Patient-Reported Symptom Monitoring During Chemotherapy—Reply. JAMA. 2017;318(19):1935–1936. doi:10.1001/jama.2017.14903
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