Case Study: 統計解析に関する査読者のコメントと解説

2. 評価尺度の明確化

The primary end point was recurrence-free survival, and the secondary end points included incidence and risk recurrence, recurrence-free interval, and overall survival.
The authors should define what they have considered as event in all the outcomes. E.g., was it the first recurrence (for the recurrence type outcomes), was it death from any cause (for the survival type outcomes). Also they should specify the difference in the definition of the recurrence free survival and recurrence free interval.
The primary endpoints were time to first recurrence and recurrence-free survival, and the secondary endpoints were disease-specific survival and overall survival. ・・・We recorded first recurrences and deaths from any cause. We defined recurrence as the appearance of new lesions with radiological features typical of DDD disease, seen by at least two imaging methods, and was separated into six classifications: overall recurrence (tumours at any time or at any site); early recurrence (any recurrence type during the first 2 years); local recurrence (tumours within 2 cm of the surgical margin); ・・・ The first detected recurrence was documented by two independent radiologists unaware of the study group; any recurrence arising after the first event was not recorded. ・・・
治療効果判定のための評価尺度を何にしたかを,主要な評価尺度と副次的な評価尺度に分けて記載します。 また,その定義や評価方法もはっきりさせておく必要があります。 ここでは,最初の再発までの期間と無再発期間を主要評価尺度と決めていますが, 再発を6つに分類してそれぞれの再発で治療群,対照群の頻度を比較しています。

評価尺度は,客観的な尺度と主観的な尺度に分けることができます。 客観的な尺度の例は生存期間,血圧や血糖値などの検査値であり,データ収集,解析方法で問題となることは少ないと思います。 一方の主観的な尺度は,症状や痛みの変化などを著明改善:1,中等度改善:2・・・などと数値化したもので医師や患者自らが評価します。 したがって,各カテゴリーの定義が評価者にとっても読者にとってもわかりやすく誤解のないように表現されていなければなりません。
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