Olver I N, Simon R M, Aisner J
Cancer Treat Rep. 1986 May;70(5):555-63.
Methodological issues encountered in reviewing the antiemetic literature are discussed. Variables affecting antiemetic assessment include those relating to the patient, the emetic stimulus, and the differences in action of the antiemetic drugs. Study design questions including the desirability of randomization, double blinding, use of controls, and stratifications for factors such as previous exposure to chemotherapy and strength of the emetic stimulus are discussed. From a statistical viewpoint a parallel subject design with adequate sample size is recommended. The problems of standardizing the evaluation of nausea and vomiting are considered and simple ordinal scales grading severity are suggested. The patient's overall assessment of tolerance of therapy is of primary importance.
讨论了在回顾止吐文献时遇到的方法学问题。影响止吐评估的变量包括与患者、催吐刺激以及止吐药物作用差异相关的变量。探讨了研究设计问题，包括随机化、双盲、对照的使用以及针对既往化疗暴露和催吐刺激强度等因素的分层的可取性。从统计学角度推荐采用具有足够样本量的平行受试者设计。考虑了恶心和呕吐评估标准化的问题，并提出了简单的按序评分量表来分级严重程度。患者对治疗耐受性的总体评估至关重要。
