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治 療 Therapy

治 療 Therapy. 庭棻 , 育宛. 治療 (Therapy). 效度與臨床重要性 綜述性 systemic review, 單一研究. 有關治療 ( 個別隨機試驗 ) 的證據是有效的嗎 ?. 病人的治療分配是隨機的嗎 ? 隨機分派過程是否隱匿 ? 對照組與實驗組病人在進入試驗時是否相似 ? 是否所有的病人都被放到原先分派的組別中做分析 (intention-to-treat analysis)? 病人、醫師、研究員是否對治療不知情 (blind)? 對照組與實驗組是否被同等對待 ?. Data collection. Data Monitoring.

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治 療 Therapy

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  1. 治 療Therapy 庭棻,育宛

  2. 治療 (Therapy) • 效度與臨床重要性 • 綜述性 systemic review, 單一研究

  3. 有關治療(個別隨機試驗)的證據是有效的嗎? • 病人的治療分配是隨機的嗎? • 隨機分派過程是否隱匿? • 對照組與實驗組病人在進入試驗時是否相似? • 是否所有的病人都被放到原先分派的組別中做分析(intention-to-treat analysis)? • 病人、醫師、研究員是否對治療不知情(blind)? • 對照組與實驗組是否被同等對待?

  4. Data collection Data Monitoring Statistical analysis End points

  5. Entry, Randomization, and Follow-up of Patients in the Hypertension in the Very Elderly Trial Beckett NS et al. N Engl J Med 2008;358:1887-1898

  6. Baseline Characteristics of the Patients Beckett NS et al. N Engl J Med 2008;358:1887-1898

  7. 如何決定研究中所描述治療的可能效益 (或傷害) 是否重要

  8. 如何決定研究中所描述治療的可能效益 (或傷害) 是否重要 • 治療的效果有多大 • 治療效果的估計有多精確 (95信賴區間；95% CI)

  9. 表5.3 效果大小的測量 相對危險降低度 (relative risk reduction, RRR) 相對效益增加度 (relative benefit increase, RBI) 相對風險增加度 (relative risk increase, RRI)

  10. 相對風險降低度。RRR不能反映沒有治療的事件危險性，因此無法區分治療效果的大小。相對風險降低度。RRR不能反映沒有治療的事件危險性，因此無法區分治療效果的大小。 • 要看出治療效果的大小，必須以兩組間的差異絕對值來估計，即絕對風險降低度(ARR)。 • 因此，在評估治療效果時，ARR是一個比RRR更有意義的度量方式。 • 文章常以RRR 來表示療效，但用NNT (Number Needed to Treat), NNH來表達更為直接。

  11. NNT (number need to treat) • NNT：在研究試驗期間，我們必須使用試驗性療法治療多少個病人，才能預防一個額外的壞結果。 • NNT=1/ARR=1/∣CER-EER∣ • NNT必須為一個整數 • NNH (number need to harm) =1/ARI (使用試驗性療法治療多少個病人，才能造成一個額外的壞結果。)

  12. Treatment Effects • Occurrence of diabetic retinopathy at 5 years among insulin-dependent diabetic in the DCCT trial • Usual insulin regimen (CER: control event rate): 38% • Intensive insulin regimen (EER: experimental event rate): 13% • Risk Reduction (calculation): NNT • Absolute risk reduction (ARR) = │CER-EER│= 38%-13% = 25% • Relative risk reduction (RRR) = │CER-EER│/CER = 25%/38% =66% • Number needed to treat (NNT) = 1/ARR = 1/25% = 4 patients NNT: The number of patients that need to be treated to prevent one bad outcome or get one good outcome.

  13. Harm • The proportion of patients with at least one episode of symptomatic hypoglycemia • Usual insulin regimen (CER: control event rate): 23% • Intensive insulin regimen (EER: experimental event rate): 57% • Risk Increase(calculation): NNH • Absolute risk increase (ARI) =│EER - CER│ = 57%-23% = 34% • Relative risk increase (RRI) =│EER-CER│/CER = 57%-23%/ 23% = 148% • Number needed to harm (NNH) = 1/ARI = 1/0.34 = 3 patients (整數) NNH: The number of patients that need to be treated to cause one bad outcome (being harmed).

  14. 一些有NNT的案例

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