Case Study: 統計解析に関する査読者のコメントと解説

1. 無作為化割付け方法の記述

The eligible patients were assigned by computer-generated randomization to receive either XXXX therapy or no adjuvant treatment.
The authors should give more details on the method of randomization, which was used. Also explain why they based their size calculation on one-sided log-rank test.
We randomly assigned eligible patients XXX therapy or no adjuvant treatment. [1]Randomisation was done by permuted block is without stratification, on receipt of the pathological confirmation of T category, no later than 1 week after surgery.
無作為化臨床試験の結果を論文にまとめる際に,無作為化割付けの具体的な方法を明記することが求められます。 ここでは,permuted block without stratification(層別因子を設定しない置換ブロック)を用いた,と記述しています。

(1) 無作為化割付け法(permuted block, minimization method など)
(2) 層別因子
(3) 施設内バランスの有無
(4) 割付け時期


(1) Random assignment was performed using permuted blocks of four assignments in random sequence. In trial JJJ, treatment assignment were balanced according to nodal status, the type of surgery, the intended radiotherapy, and institution with the use of a biased-coin minimization algorithm.

また,二重盲検法を採用している場合には,”blinding procedures”として盲検法について記述することも必要です。
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