實證醫學基本課程文獻評讀與數據擷取

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實證醫學基本課程文獻評讀與數據擷取

實證決策管理委員會實證醫學中心何鴻鋆

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實證醫學教育訓練

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進行方式: 課前線上學習、現場討論

• 先找好科部內兩位指導老師，撰寫CAT過程中若有疑問，先與指導老師討論。特別是專科知識討論與未來進一步研究方向。

• 請按進度先自行完成線上影音學習，於上課前完成提交初稿，以利指導者課前審視。上課時將直接針對相關進度繳交之CAT內容討論。

• 請按照預約時段準時到場，逾時不候，亦無法補課，

未完成之進度遞延至下一梯次。兩梯次內未完成則需重新報名等候安排。

• 為讓您接收訊息更快速直接，學員間也可以互相討論取暖，請加入Line群組！

• http://line.me/R/ti/g/7OEJpEycyf

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呈現介面使用表格

201707 R4 EBM CAT模板.doc

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……

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進度

1. 題目設定與形成及精準搜尋與證據選定

2. 證據研究方法評讀

3. 證據數據擷取 4. 證據應用評估

5. FINAL CAT (Critical Appraisal Topic) 產出

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2. 證據研究方法評讀

2.1 選定證據文獻 2.2 評讀表選定

2.3 bias評讀 (Validity)

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2.1 選定證據文獻

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檢索結果(可考慮列入評讀文獻)

• 原CPG或UpToDate在相關章節的參考文獻

• 在DataBase搜尋到的文獻

最後列入(評讀)參考文獻: 出略篩選文獻符合我們臨床問題的 PICO

初步評讀: (需寫出文獻PICOT與研究設計)

選定文獻「必要條件」:

– 文獻PICO符合我們臨床問題的PICO

– 較能解決該類型問題的研究設計

• 通過的文獻才進入真正評讀

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2.1 選定證據文獻

建議文獻選擇考量:

• 列出參考guideline/UpTodate中相關參考文獻

• 列出在PubMed/EmBase找到的文獻

• 依據與緣設定PICO最符合、證據等級較高、發表年較近緣則選擇

• 將選定評讀文獻中研究方法: 收案對像(P)，探討的處置(I)、對照組處置(C)與outcomes列出。另外處置使用時間/觀察時間(T)列出。假如無法找到對應項目列出

，前在這篇文獻不是適當文獻。

• 研究設計方法為何?除非罕見疾病

，否則無對照組研究不會列入評讀。

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範例

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2.2 評讀表選定

• 依照第一次上課認定所選主題為何種型態選擇模板中的表格

• origin paper用p3的，他們就不用再分RCT, cohort,case series。

SR 兩者選一。診斷型的只有CASP

• 假如發現評讀文章時，無法順利竹項填入，要不是選錯文獻，要不

選錯表格。 ⁹

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2.3 bias評讀 (Validity) Critical Appraisal

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Source Protection

Baseline imbalance Randomization

Performance Blinding of caregivers, careful monitoring

& analysis

Placebo-effect Blinding of patients

Attrition Careful follow-up & ITT analysis Detection Valid measurement

Blinding of outcome assessors Analytical Careful analyses

Reporting Report all relevant planned measurements

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Sources of bias

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第一關: Randomization

http://www.cancer.gov/about-cancer/treatment/clinical-trials/what- 12

are-trials/randomization/clinical-trial-randomization-infographic

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常見Randomization的方法

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Allocation Concealment

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Allocation Concealment

Minimum criteria for adequate allocation concealment schemes

• Sequentially numbered, opaque, sealed envelopes (SNOSE)

• Sequentially numbered containers

• Pharmacy controlled

• Central randomisation

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THE LANCET • Vol 359 • Feb 16, 2002 • www.thelancet.com

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Allocation Concealment

THE LANCET • Vol 359 • Feb 16, 2002 • www.thelancet.com

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Lost Follow-up -- Attrition

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https://www.youtube.com/watch?v=dMfC-SSBZi0

Intention to Treat

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Lost Follow-up -- Intention to Treat

https://www.youtube.com/watch?v=Kps3VzbykFQ

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Blind

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研究設計 Double-Blind

http://library.downstate.edu/EBM2/2300.htm

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Blinding

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Detection bias

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• Valid measurement

A good measure should be

• Valid

• Reliable

• Sensitive

Valid exist when

• “testing for the right thing”

• A valid measure actually

measures what

it is intend to

measure

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Criteria for Measurements

A good measure should be

• Valid

• Reliable

• Sensitive

Valid exist when

• “testing for the right thing”

• A valid measure actually measures what it is intend to measure

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Detection bias

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• Valid measurement

• Blinding of outcome assessors

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Analytical bias

• Analyzing the data incorrectly

• Due to the way that the results are evaluated

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Reporting bias/ Selective reporting

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https://www.youtube.com/watch?v=dMfC-SSBZi0

Type of reporting bias Definition

Publication bias The publication or non-publication of research findings, depending on the nature and direction of the results Time lag bias The rapid or delayed publication of research findings,

depending on the nature and direction of the results Multiple (duplicate)

publication bias

The multiple or singular publication of research findings, depending on the nature and direction of the results Location bias The publication of research findings in journals with

different ease of access or levels of indexing in standard databases, depending on the nature and direction of results.

Citation bias The citation or non-citation of research findings, depending on the nature and direction of the results

Language bias The publication of research findings in a particular language, depending on the nature and direction of the results

Outcome reporting bias

The selective reporting of some outcomes but not others, depending on the nature and direction of the results

實證醫學基本課程 文獻評讀與數據擷取