第 6 章 Pattern-Mixture Model 50
6.10 その他の PMM
6.10.5 中止理由別(AE とその他の理由で区別)の pattern imputation
この補完方法は,脱落パターンごとに欠測値を補完するのではなく,たとえば脱落理由として有害事象の影 響で脱落した人とそれ以外の理由で脱落した人でパターンを作り,欠測値の補完を行う(Ratitch et al., 2013).
投与中止後の推移を想定しているため,対象とするestimandはeffectivenessとなる.有害事象で途中脱落した 試験治療群及び対照群の被験者の欠測データには,両群のベースラインの応答変数データで補完する.一方,
その他の理由で脱落した試験治療群/対照群の被験者の欠測値には,それぞれの群の試験を完了したパターンの 被験者のデータでそれぞれ補完をする(CCMV).この補完方法の特徴は,特に疼痛の領域において使用される ベースラインのデータで単補完するBOCFに近いコンセプトをもっている.もし,被験者が薬剤の服用を続け ることができないならば,脱落後のその被験者に治療のベネフィットは与えられなかったと考えることは自然 である.このため,脱落後の被験者の欠測データはベースラインの応答変数データで補完し保守的な取扱いを する.BOCFでは単補完であり,補完値の不確実性を考慮していないことから,この補完方法はこの不確実性 を考慮した多重補完とBOCFを組み合わせた方法となっている.
上記以外にも,中止理由ごとに別々の補完モデルを用いることや,残りの症例がMARを仮定した補完を 行うことなど,中止理由別のpatter imputaionの事例が出始めていることに注目されたい(計量生物セミナー,
2015).
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