實證文獻判讀及文獻評析技巧 - acshn.org.tw · 評析系統性回顧文獻 systematic...
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學校護理人員實證護理學術研討會
實證文獻判讀及文獻評析技巧
講師: 亞東醫院教學部/家醫科 謝其磐醫師
2016/5/28 於 板橋高中
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http://med.fsu.edu/index.cfm?page=medicalinformatics.ebmTutorial
http://med.fsu.edu/index.cfm?page=medicalinformatics.ebmTutorial
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實證醫學五步驟
形成一個可以回答的臨床問題
搜尋最佳證據
嚴格評讀證據之效度與重要性
將臨床專業與病人價值觀相結合
評估執行效果及效用
由台北醫學大學.市立萬芳醫院實證醫學中心經授權作中文編譯,英國The Centre for Evidence-Based Medicine及The National Library for Health, NHS所出版由Carl Heneghan及Paul Glasziou撰寫之Quesions Log: A tool for ' just in time' learning手冊。
PICO
搜尋資料
3
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形成一個可回答的臨床問題 •Patient/Population or Problem
•病人或族群的年齡層、體質、疾病史、過去史
•Ex: A 50 year-old woman with a family history of breast cancer P
• Intervention or Indicator
•治療、診斷、預後、成本效益分析等研究的主題
• Ex: Hormone replacement therapy I
•Comparator
•有無其他方式或選擇?
•Ex: Placebo C
•Outcome
•效果是甚麼?或是預計的結果?
•Ex: Prevention of Alzheimer’s disease O
4 衛生政策數位學院 http://ehealthpolicy.nhri.org.tw/lecture.htm ,實證醫學資料庫推廣專案種子師資培訓營
PICO的好處:(1)聚焦問題,容易找到關鍵字。(2)分辨臨床問題的型態,如Thearapy治療、Harm傷害、Diagnosis診斷、Prognosis預後與Etiology病因等類別。(3)協助瞭解何者是最好且最適合之研究設計,據此而產生之研究結果才是最佳證據等級的文獻。
http://ehealthpolicy.nhri.org.tw/lecture.htm
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搜集最佳證據
使用資訊技術協助搜尋,配合搜尋輔助工具與 MeSH 語法
MeSH 醫學專業詞彙 eg. PubMed Clinical Query eg. [dp] = date of publish; [ptyp] = publication type
適當使用布林邏輯 AND, OR, .....,縮小搜尋結果至約10至30篇
選擇合適之資訊資源檢索
PICO 問題轉譯成適當關鍵字,組織檢索語句
國泰醫院實證醫學中心 http://ebm.cgh.org.tw/ebm-handon-6quar,六刻鐘EBM套餐
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http://ebm.cgh.org.tw/ebm-handon-6quarhttp://ebm.cgh.org.tw/ebm-handon-6quarhttp://ebm.cgh.org.tw/ebm-handon-6quarhttp://ebm.cgh.org.tw/ebm-handon-6quarhttp://ebm.cgh.org.tw/ebm-handon-6quar
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大綱
1. 隨機臨床試驗 (randomized controlled trial, RCT) 的文獻判讀
2. 系統性回顧 (systematic review) 的文獻判讀
3.臨床指引 (clinical guideline) 的文獻判讀
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隨機臨床試驗 (randomized controlled trial, RCT) 的文獻判讀
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臨床情境 (練習)
• 一位65歲的女士要去美國看她剛出生的孫子,這是她第一次搭飛機長途旅行,因此,她到處詢問長途飛行的注意事項。她找到旅遊雜誌上一篇相關報導,其中提到穿彈性襪可以預防腳部靜脈栓塞。因此,她來門診時,問醫師她需不需要買彈性襪來穿?
2013 實證醫學種子師資培訓工作坊
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實證醫學五步驟
Step 1: converting the need for information (about prevention, diagnosis, prognosis, therapy, causation, etc.) into an answerable question.
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病人最需要解決的問題?
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使用 PICO 寫出您最想詢問的 前景問題
• P (patient/population)
• I (intervention/exposure)
• C (comparison)
• O (outcome)
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Type of study design 這個問題適合用哪一種研究設計回答
• Systematic review
• Randomized controlled trial
• Cohort study
• Case-controlled study
• Cross-sectional study
• Other
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實證醫學五步驟
Step 2: tracking down the best evidence with which to
answer that question.
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文獻搜尋 PubMed
Keyword MeSH term
• P
• I
• C
• O
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搜尋 RCT/Systematic study的技巧
• PubMed Clinical Queries
• PubMed Advanced Publication type randomized controlled trial 或 meta analysis
• SUMSearch, http://sumsearch.org/
• Cochrane Database of Systematic Review
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其它搜尋相關文獻的技巧
• 此文章引用了哪些文章 (references) – Textbook 的 reference
– Review article 的 reference
– Guideline 的 reference
– Original article 的 reference
• 此文章被哪些文章引用 (cite) – Scholar Google
– JCR 資料庫
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實證醫學五步驟 Step 3: 嚴格評讀文獻
Step 3: critically appraising that evidence for its
– validity (closeness to the truth)
– impact (size of the effect)
– applicability (usefulness in our clinical practice)
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評讀文獻的步驟
1. 閱讀文章,決定此篇文章內容是否直接回答您的臨床問題。
2. 評析文章的有效性 (validity)。
3. 評析文章的重要性 (importance)。
4. 評估如何將文章應用在您的病人情境。
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Frequency and prevention of symptomless deep-vein thrombosis in long-haul flights: a randomised trial.
• Lancet. 2001 May 12;357(9267):1485-9.
• Scurr JH, Machin SJ, Bailey-King S, Mackie IJ, McDonald S, Smith PD.
• Department of Surgery, Royal Free and University College Medical School, London, UK.
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methods
• 89 male and 142 female passengers over 50 years of age with no history of thromboembolic problems.
• Randomly allocated to one of two groups: – one group wore class-I below-knee graduated elastic
compression stockings
– the other group did not
• journeys lasting more than 8 h per flight (median total duration 24 h), returning to the UK within 6 weeks.
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Outcomes
• Questionnaire – duration of air travel
– wearing of stockings, symptoms in the lower limbs, and illnesses and medication taken
• Duplex ultrasonography – assess the deep veins before and after travel
• Blood samples were analysed for two specific common gene mutations – factor V Leiden (FVL)
– prothrombin G20210A (PGM)
• A sensitive D-dimer assay
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Directness 方向性
• 臨床問題的 PICO
• P
• I
• C
• O
• 文獻實驗中的 PICO
• P
• I
• C
• O
本文的內容是否直接且正確解答您的臨床問題?
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Validity 有效性 (以評讀 RCT為例)
• 根據本文研究設計判斷回答以下問題 (是/否/不知),並評估偏差的危險性 (高/低/不確定)。
1. 病人是否隨機分配至治療各組?
2. 分配過程是否隱匿?
3. 一開始各組條件是否相同?
4. 治療當中,研究對象是否不知道自己的組別?
5. 治療當中,提供照顧的醫療人員是否不知道研究對象的組別?
6. 治療當中,結果評估者是否不知道誰是實驗組?
7. 一開始隨機分配後的病人是否都被納入分析?
8. 病人追蹤率是否夠高? (20% 不好)
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介入效果 DVT 12 人 DVT 0 人 副作用 SVT 0 人 SVT 4 人
DVT: deep vein thrombosis
SVT: superficial thrombophlebitis
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• Intention-to-treat analysis – 分析時納入一開始分組時的所有受試者,包含 dropout
和 missing data。
– 如何處理 missing data? 最保守的方法是假設所有 dropout 的人都發生 event。
• Per-protocol analysis – 只分析完成所有測試的受試者。
– bias associated with the non-random loss of the participants?
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Result 結果 (Per-protocol analysis)
發生 DVT 人數 無 DVT 人數 Total
實驗組人數 (彈性襪)
0 100 100
對照組人數 (無彈性襪)
12 88 100
Total 12 188
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Result 結果 ( Intention-to-treat analysis)
(最保守的估計法,將退出的受試者全視為有發生DVT)
發生 DVT 人數 無 DVT 人數 Total
實驗組人數 (彈性襪)
15
(0+15)
100 115
對照組人數 (無彈性襪)
28
(12+16)
88 116
Total 43 188
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Control event
rate
Experimental
event rate
Relative risk
reduction
Absolute
risk
reduction
Number
needed to treat
CER EER RRR =
|CER-EER|/CER
ARR =
|CER-EER|
NNT = 1/ARR
12% 0 1 12% 1/(12%) = 8.33
NNT = 9
(無條件進位)
最重要的治療/預防效果的呈現
以 Per-protocol analysis 的數據
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副作用結果的呈現 SVT: 淺部靜脈炎
發生 SVT 人數 無 SVT 人數 Total
實驗組人數 (彈性襪)
4 96 100
對照組人數 (無彈性襪)
0 100 100
Total 4 196
以 Per-protocol analysis 的數據
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治療的效果有多精準?
• 請描述 95% confidence interval 和統計上的意義。
• 實驗組發生 DVT: 10% (95% CI 4.8-16.0%)
• 對照組發生 DVT: 0% (95% CI 0-3.2%)
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實證醫學五步驟
Step 4: integrating the critical appraisal with
– our clinical expertise
– our patient’s unique biology, values and circumstances
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Applicability 應用性
• 1. 有沒有任何生物或醫學上的因素會影響本文結果應用在您的病人身上? (例如:性別、種族、年齡、病人的合併症等等)
• 2. 有沒有任何社會或經濟上的因素,會影響本文結果應用在您病人身上的效果?
• 3. 請評估在您的病人身上,可能的治療效果如何?
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實證醫學五步驟
• Step 5: evaluating our effectiveness and efficiency in executing steps 1–4 and seeking ways to improve them both for next time.
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系統性回顧 (systematic review) 的文獻判讀
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評析系統性回顧文獻 systematic review
• 我們已經讀了一篇 RCT,接下來想看看,是否有其它類似研究文獻支持或反對這樣的結果。於是我們想找一篇 systematic review 的文章。
• J Adv Nurs. 2005 Jul;51(1):83-98.
• Graduated compression stockings as prophylaxis for flight-related venous thrombosis: systematic literature review.
• Hsieh HF, Lee FP.
• Department of Nursing, Fooyin University, Kaohsuing, Taiwan.
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Directness 方向性
• 臨床問題的 PICO
• P
• I
• C
• O
• 文獻實驗中的 PICO
• P
• I
• C
• O
本文的內容是否直接且正確解答您的臨床問題?
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Validity 有效性
1. 用於篩選文章的標準是否適當?
2. 有沒有漏掉重要的文章?
3. 被納入的文章是否品質良好?
4. 被納入的文章的評估標準是否可被重複檢視?
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Result 結果的評讀
• 1. 本回顧結果的效果有多大? – 此系統性分析如何呈現結果?
• forest plot
• table
– 此統統性回顧是顧進行 meta-analysis?
– 如果有 meta-analysis,其總合結果的效應值 (pooled effect size) 如何呈現? • Odds ratio, risk ratio, risk difference, mean difference, weighted
mean difference…
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Result 結果的評讀
• 2. 本回顧納入的文章彼此間相似嗎?
– 此回顧如何分析研究中的異質性?
• 臨床的異質性
• 統計上的異質性
– 是 fixed effect model or random effect model
• 本回顧的效果有多精榫?
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統計上的異質性 (heterogeneity)
• 2
2 > df, 異質性存在
• P value
P < 0.1,異質性存在
• I2 < 25% 異質性低
~ 50% 異質性中等
> 75% 異質性高
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Applicability 應用性
• 1. 有沒有任何生物或醫學上的因素會影響本文結果應用在您的病人身上? (例如:性別、種族、年齡、病人的合併症等等)
• 2. 有沒有任何社會或經濟上的因素,會影響本文結果應用在您病人身上的效果?
• 3. 有沒有進行 subgroup analysis 的必要?
• 4. 請評估在您的病人身上,可能的治療效果如何?
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臨床指引的評讀 -- 從證據到建議
(The Appraisal of Clinical Guidelines: from Evidence to Recommendations)
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CHEST 2012; 141(2)(Suppl):e531S–e575S
CHEST 2012; 141(2)(Suppl)
當期有一系列關於抗血栓治療的臨床指引
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CHEST 2012; 141(2)(Suppl):e531S–e575S
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綜合搜尋 guideline 的資料庫
• SUMSearch (包括 Medline, DARE, NGC)
http://sumsearch.org/
• PubMed http://www.ncbi.nlm.nih.gov/pubmed
– 選 Advanced Publication Type guideline
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搜尋 guideline 的網站
• National Guideline Clearinghouse (NGC) 美國 http://www.guideline.gov/
• National Institute for Health and Care Excellence (NICE) 英國 http://www.evidence.nhs.uk/
• CMA Infobase: Clinical Practice Guidelines Database (CPGs) 加拿大 https://www.cma.ca/En/Pages/clinical-practice-guidelines.aspx
• Scottish Intercollegiate Guidelines Network (SIGN) 蘇格蘭 http://www.sign.ac.uk/
• National Health and Medical Research Council (NHMRC) 澳大利亞http://www.nhmrc.gov.au/guidelines-publications
• eGuidelines http://www.eguidelines.co.uk/
• Guidelines International Network (G-I-N) http://www.g-i-n.net/
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Specification of outcomes: ensuring comprehensiveness
• Systematic reviews may even focus on a single outcome, and lack some key outcomes, particularly harms.
– the impact of statins on stroke
– vitamin D on nonvertebral fractures
• Recommendations in guidelines require consider
– all important outcomes to patients, including morbid and mortal events and adverse effects
– the use of resources paid for by third parties
– impacts on those who care for patients
– public health impacts (e.g., the spread of infections or antibiotic resistance)
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Guideline 的評讀與撰寫方法
• AGREE II – Appraisal of Guidelines, Research and Evaluation
• GRADE – The Grading of Recommendations Assessment,
Development and Evaluation (GRADE) Working Group
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Guideline 的評讀: AGREE II (Appraisal of Guidelines, Research and Evaluation)
AGREE II is the new (2010) international tool to assess the quality and reporting of practice guidelines.
http://www.agreetrust.org/resource-centre/agree-ii/
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臨床指引品質評讀工具: AGREE II (2013年版)
• AGREE II 6 domains (23 items) + Overall assessment (2 global rating items)
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AGREE II
• Domain 1. Scope and Purpose
• Domain 2. Stakeholder Involvement
• Domain 3. Rigour of Development
• Domain 4. Clarity of Presentation
• Domain 5. Applicability
• Domain 6. Editorial Independence
• Overall assessment
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Domain 1. Scope and Purpose
• 1. The overall objective(s) of the guideline is (are) specifically described. 整體目的有具體描述。
• 2. The health question(s) covered by the guideline is (are) specifically described. 指引所涵蓋的健康問題有具體描述。
• 3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described. 指引要應用的族群(病患,大眾,等等)有具體描述。
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Domain 2. Stakeholder Involvement
• 4. The guideline development group includes individuals from all relevant professional groups. 指引發展團隊包括各類相關的專家團體。
• 5. The views and preferences of the target population (patients, public, etc.) have been sought. 目標族群(病患,大眾,等等)的觀點和偏好有被納入。
• 6. The target users of the guideline are clearly defined. 有清楚定義指引的使用者。
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Domain 3. Rigour of Development
• 7. Systematic methods were used to search for evidence. 運用系統化的方法搜尋證據。
• 8. The criteria for selecting the evidence are clearly described. 挑選證據的標準有明確描述。
• 9. The strengths and limitations of the body of evidence are clearly described. 證據本身的強度和限制有清楚描述。
• 10. The methods for formulating the recommendations are clearly described. 制定建議的方法有清楚摸述。
• 11. The health benefits, side effects, and risks have been considered in formulating the recommendations. 制定建議的過程有考慮健康效益,副作用,及風險。
• 12. There is an explicit link between the recommendations and the supporting evidence. 建議和支持它的證據有明顯的關聯。
• 13. The guideline has been externally reviewed by experts prior to its publication. 指引在發表之前曾有外部專家審閱過。
• 14. A procedure for updating the guideline is provided. 有提供更新指引的程序。
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Domain 4. Clarity of Presentation
• 15. The recommendations are specific and unambiguous. 建議具體不含糊。
• 16. The different options for management of the condition or health issue are clearly presented. 對於處理某情境或健康議題的不同選擇有清楚呈現。
• 17. Key recommendations are easily identifiable. 關鍵的建議很容易辨識。
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Domain 5. Applicability
• 18. The guideline describes facilitators and barriers to its application. 指引中有描述應用時可能遇到的助力和阻礙。
• 19. The guideline provides advice and/or tools on how the recommendations can be put into practice. 指引中有提供建議被如何實際運用的忠告和(或)工具。
• 20. The potential resource implications of applying the recommendations have been considered. 指引中有提及應用建議時可能用到的資源。
• 21. The guideline presents monitoring and/or auditing criteria. 指引有呈現監測和檢查的標準。
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Domain 6. Editorial Independence
• 22. The views of the funding body have not influenced the content of the guideline. 贊助者的意見沒有影響指引的內容。
• 23. Competing interests of guideline development group members have been recorded and addressed. 指引發展團隊的成員間的利益競爭有記錄和註明。
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Guideline 的開發,撰寫,和評讀: GRADE approach
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group
http://www.gradeworkinggroup.org/
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A schematic view of the GRADE approach for synthesizing evidence and
developing recommendations (GRADE Handbook).
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文獻評讀的常用工具
Critical Appraisal Skills Programm (CASP)
• http://www.casp-uk.net/
• EBM E-learning 課程
http://www.casp-uk.net/#!e-learning/cd70
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Critical Appraisal Skills Programme (CASP) http://www.casp-uk.net/
• CASP critical appraisal checklists: – CASP Randomised Controlled Trial
– CASP Systematic Review
– CASP Cohort Study
– CASP Case Control Study
– CASP Qualitative Research
– CASP Economic Evaluations
– CASP Diagnostic Test
– CASP Clinical Prediction Rule
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實做練習
• 以台灣的”骨質疏鬆症臨床治療指引”為材料,用 AGREE II 的方法,來評讀此指引。
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感謝聆聽
• 課後討論。
• 請多多批評指導。