33. アウトカム測定の記載事例
• Exposure time windowは薬物内服までの時間ではなく、薬効
発現までの時間を考慮し設定する。
- We tested the definition of current use by varying the width of the
exposure time to 60 and 30 days. (Methods section)
• アウトカムは外部検証されたものを使用する。アウトカム
の定義が複数があるなどの場合、感度分析での確認を。
- We Recent reviews of all validation studies found that medical data in the
CPRD are of high quality. (Methods section)
• 疾病罹患をアウトカムにする場合、アウトカムの定義は類
似した対象患者で検証された定義を用いる。
- We identified acute kidney injury events by using hospital admission data,
whose validity has been demonstrated in the more clinically severe
subgroup requiring dialysis (sensitivity 90%; positive predictive value 94%).
When we restricted the analysis to this more severe subgroup, we
observed a lower point estimate. (Discussion section)
BMJ. 2013 Jan 8;346:e8525. 33
63. 限定化と効果量の推移
• 制限化と死亡率の推移
0: Drug user vs non-users (No restriction)
1: Incident drug users vs non-users
2: Incident drug users vs
incident comparison drug user
3: Incident drug users vs
incident comparison drug users
without contraindications
4: Adherent incident users vs
adherent incident comparison drug uses
without contraindications
5: RCT population
Schneeweiss S, et al. Med Care. 2007 Oct;45(10 Supl 2):S131-42. 63