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词条 Levels of evidence
释义

  1. Definition

  2. History

     Canada  USA  UK  Global 

  3. Proponents

  4. Limitations

  5. See also

  6. References

  7. Bibliography

  8. External links

{{Contradicts other|date=November 2014|1=Evidence-based medicine#Assessing the quality of evidence}}

In medicine, levels of evidence (LoE) are arranged in a ranking system used in evidence-based practices to describe the strength of the results measured in a clinical trial or research study. The design of the study (such as a case report for an individual patient or a double-blinded randomized controlled trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence.

Definition

The National Cancer Institute defines levels of evidence as "a ranking system used to describe the strength of the results measured in a clinical trial or research study. The design of the study [...] and the endpoints measured [...] affect the strength of the evidence."[1]

History

Canada

The term was first used in a 1979 report by the "Canadian Task Force on the Periodic Health Examination" (CTF) to "grade the effectiveness of an intervention according to the quality of evidence obtained".[2]{{rp|1195}}

The task force used three levels, subdividing level II:

  • Level I: Evidence from at least one randomized controlled trial,
  • Level II1: Evidence from at least one well designed cohort study or case control study, i.e. a controlled trial which is not randomized
  • Level II2: Comparisons between times and places with or without the intervention
  • Level III: Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.

The CTF graded their recommendations into a 5-point A–E scale: A: Good level of evidence for the recommendation to consider a condition, B: Fair level of evidence for the recommendation to consider a condition, C: Poor level of evidence for the recommendation to consider a condition, D: Fair level evidence for the recommendation to exclude the condition, and E: Good level of evidence for the recommendation to exclude condition from consideration.[2]{{rp|1195}}

The CTF updated their report in 1984,[3] in 1986[4] and 1987.[5]

USA

In 1988, the United States Preventive Services Task Force (USPSTF) came out with its guidelines based on the CTF using the same 3 levels, further subdividing level II.[6][7]

  • Level I: Evidence obtained from at least one properly designed randomized controlled trial.
  • Level II-1: Evidence obtained from well-designed controlled trials without randomization.
  • Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
  • Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
  • Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Over the years many more grading systems have been described.[8]

UK

In September 2000, the Oxford (UK) CEBM Levels of Evidence published its guidelines for 'Levels' of evidence re claims about prognosis, diagnosis, treatment benefits, treatment harms, and screening. It not only addressed therapy and prevention, but also diagnostic tests, prognostic markers, or harm. The original CEBM Levels was first released for Evidence-Based On Call to make the process of finding evidence feasible and its results explicit. As published in 2009[9]{{sfn|Burns el al|2011}} they are:

  • 1a: Systematic reviews (with homogeneity) of randomized controlled trials
  • 1b: Individual randomized controlled trials (with narrow confidence interval)
  • 1c: All or none randomized controlled trials
  • 2a: Systematic reviews (with homogeneity) of cohort studies
  • 2b: Individual cohort study or low quality randomized controlled trials (e.g. <80% follow-up)
  • 2c: "Outcomes" Research; ecological studies
  • 3a: Systematic review (with homogeneity) of case-control studies
  • 3b: Individual case-control study
  • 4: Case series (and poor quality cohort and case-control studies)
  • 5: Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

In 2011, an international team redesigned the Oxford CEBM Levels to make it more understandable and to take into account recent developments in evidence ranking schemes. The Levels have been used by patients, clinicians and also to develop clinical guidelines including recommendations for the optimal use of phototherapy and topical therapy in psoriasis[10] and guidelines for the use of the BCLC staging system for diagnosing and monitoring hepatocellular carcinoma in Canada.[11]

Global

In 2007, the World Cancer Research Fund grading system described 4 levels: Convincing, probable, possible and insufficient evidence.[12] All Global Burden of Disease Studies have used it to evaluate epidemiologic evidence supporting causal relationships.[13]

Proponents

In 1995 Wilson et al.,[14] in 1996 Hadorn et al.[15] and in 1996 Atkins et al.[16] have described and defended various types of grading systems.

Limitations

The hierarchy of evidence produced by a study design has been questioned, because guidelines have "failed to properly define key terms, weight the merits of certain non-randomized controlled trials, and employ a comprehensive list of study design limitations".[17]

Stegenga has criticized specifically that meta-analyses are placed at the top of such hierarchies.[18] The assumption that RCTs ought to be necessarily near the top of such hierarchies has been criticized by Worrall.[19] and Cartwright[20]

See also

  • Evidence-based practice
  • Evidence-based medicine
  • Hierarchy of evidence
  • Jadad scale

References

1. ^{{cite web|author1=National Cancer Institute|title=NCI Dictionary of Cancer Terms: Levels of evidence|url=http://www.cancer.gov/dictionary?CdrID=446533|publisher=US DHHS-National Institutes of Health|accessdate=8 December 2014|date=n.d.}}
2. ^{{cite journal|author1=Canadian Task Force on the Periodic Health Examination|title=Task Force Report: The periodic health examination|journal=Can Med Assoc J|date=3 November 1979|volume=121| issue=9| pages=1193–1254| pmid=115569|pmc=1704686}}
3. ^{{cite journal|author1=Canadian Task Force on the Periodic Health Examination|title=Task Force Report: The periodic health examination. 2. 1984 update|journal=Can Med Assoc J|date=15 May 1984|volume=130|issue=10|pages=1278–1285|pmc=1483525|pmid=6722691}}
4. ^{{cite journal|author1=Canadian Task Force on the Periodic Health Examination|title=Task Force Report: The periodic health examination. 3. 1986 update|journal=Can Med Assoc J|date=15 May 1986|volume=134|issue=10|pages=721–729}}
5. ^{{cite journal|author1=Canadian Task Force on the Periodic Health Examination|title=Task Force Report: The periodic health examination. 2. 1987 update|journal=Can Med Assoc J|date=1 April 1988| volume=138| issue=7| pages=618–26|pmc=1267740|pmid=3355931}}
6. ^{{cite book|first1=Robert |last1=Lawrence|date=1989|publisher=DIANE Publishing|isbn=978-1568062976|author2=U. S. Preventive Services Task Force Edition |title=Guide to Clinical Preventive Services|url=https://books.google.com/?id=eQGJHgI_dR8C|accessdate=9 December 2014}}
7. ^{{cite book|author=U.S. Preventive Services Task Force|title=Guide to clinical preventive services: report of the U.S. Preventive Services Task Force|url=https://books.google.com/books?id=eQGJHgI_dR8C&pg=PR24 |date=August 1989|publisher=DIANE Publishing|isbn=978-1-56806-297-6|pages=24–}}Appendix A
8. ^{{cite web|last1=Welsh|first1=Judith|title=Levels of evidence and analyzing the literature|url=http://nihlibrary.ors.nih.gov/jw/levels_of_evidence.html|publisher=National Institutes of Health Library|accessdate=9 September 2015|date=January 2010}}
9. ^{{cite web |url=http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/ |title=Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009) |website=Centre for Evidence-Based Medicine |accessdate=25 March 2015}}
10. ^{{cite web|author=OCEBM Levels of Evidence Working Group|title=The Oxford Levels of Evidence 2'|url=http://www.cebm.net/index.aspx?o=5653}}
11. ^{{cite journal|last1=Paul|first1=C.|last2=Gallini |first2=A.|last3=Archier |first3=E.|title=Evidence-Based Recommendations on Topical Treatment and Phototherapy of Psoriasis: Systematic Review and Expert Opinion of a Panel of Dermatologists|journal=Journal of the European Academy of Dermatology and Venerology|year=2012|volume=26 |issue=Suppl 3|pages=1–10|pmid=22512675 |doi=10.1111/j.1468-3083.2012.04518.x|display-authors=etal}}
12. ^World Cancer Research Fund AICR. Food, Nutrition, and Physical Activity, and the Prevention of Cancer: A Global Perspective. American Institute for Cancer Research, Washington, DC; 2007
13. ^{{cite journal|url=http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61766-8|doi=10.1016/S0140-6736(12)61766-8|pmid=23245609|pmc=4156511|title=A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: A systematic analysis for the Global Burden of Disease Study 2010|journal=The Lancet|volume=380|issue=9859|pages=2224–2260|year=2012|last1=Lim|first1=Stephen S|last2=Vos|first2=Theo|last3=Flaxman|first3=Abraham D|last4=Danaei|first4=Goodarz|last5=Shibuya|first5=Kenji|last6=Adair-Rohani|first6=Heather|last7=Almazroa|first7=Mohammad A|last8=Amann|first8=Markus|last9=Anderson|first9=H Ross|last10=Andrews|first10=Kathryn G|last11=Aryee|first11=Martin|last12=Atkinson|first12=Charles|last13=Bacchus|first13=Loraine J|last14=Bahalim|first14=Adil N|last15=Balakrishnan|first15=Kalpana|last16=Balmes|first16=John|last17=Barker-Collo|first17=Suzanne|last18=Baxter|first18=Amanda|last19=Bell|first19=Michelle L|last20=Blore|first20=Jed D|last21=Blyth|first21=Fiona|last22=Bonner|first22=Carissa|last23=Borges|first23=Guilherme|last24=Bourne|first24=Rupert|last25=Boussinesq|first25=Michel|last26=Brauer|first26=Michael|last27=Brooks|first27=Peter|last28=Bruce|first28=Nigel G|last29=Brunekreef|first29=Bert|last30=Bryan-Hancock|first30=Claire|displayauthors=29}}
14. ^{{cite journal | year = 1995 | title = Users' guides to the medical literature. VIII. How to use clinical practice guidelines. B. what are the recommendations and will they help you in caring for your patients? The evidence-based medicine working group | url = | journal = JAMA | volume = 274 | issue = 20| pages = 1630–1632 | doi = 10.1001/jama.1995.03530200066040 | last1 = Wilson | first1 = Mark C }}
15. ^{{cite journal|doi=10.1016/0895-4356(96)00019-4|title=Rating the quality of evidence for clinical practice guidelines|journal=Journal of Clinical Epidemiology|volume=49|issue=7|pages=749–754|year=1996|last1=Hadorn|first1=David C|last2=Baker|first2=David|last3=Hodges|first3=James S|last4=Hicks|first4=Nicholas}}
16. ^{{cite journal | year = 2004 | title = Grading quality of evidence and strength of recommendations | url = | journal = BMJ | volume = 328 | issue = 7454| page = 1490 | doi=10.1136/bmj.328.7454.1490| pmid = 15205295 | pmc = 428525| last1 = Atkins | first1 = D | last2 = Best | first2 = D | last3 = Briss | first3 = P. A | last4 = Eccles | first4 = M | last5 = Falck-Ytter | first5 = Y | last6 = Flottorp | first6 = S | last7 = Guyatt | first7 = G. H | last8 = Harbour | first8 = R. T | last9 = Haugh | first9 = M. C | last10 = Henry | first10 = D | last11 = Hill | first11 = S | last12 = Jaeschke | first12 = R | last13 = Leng | first13 = G | last14 = Liberati | first14 = A | last15 = Magrini | first15 = N | last16 = Mason | first16 = J | last17 = Middleton | first17 = P | last18 = Mrukowicz | first18 = J | last19 = O'Connell | first19 = D | last20 = Oxman | first20 = A. D | last21 = Phillips | first21 = B | last22 = Schünemann | first22 = H. J | last23 = Edejer | first23 = T | last24 = Varonen | first24 = H | last25 = Vist | first25 = G. E | last26 = Williams Jr | first26 = J. W | last27 = Zaza | first27 = S | author28 = GRADE Working Group }}
17. ^{{cite journal|author1=Gugiu, PC|author2= Westine, CD|author3= Coryn, CL|author4= Hobson, KA|title=An application of a new evidence grading system to research on the chronic care model|journal=Eval Health Prof.|date=3 April 2012|volume=36|issue=1|pages=3–43|doi=10.1177/0163278712436968|pmid= 22473325|url=http://ehp.sagepub.com/content/36/1/3.long|accessdate=8 December 2014|citeseerx= 10.1.1.1016.5990}}
18. ^{{cite journal | title = Is meta-analysis the platinum standard of evidence? | journal = Stud Hist Philos Biol Biomed Sci | volume = 42 | issue = 4 | pages = 497–507 | year = 2011 | url = https://www.academia.edu/2310140 | pmid = 22035723 | doi = 10.1016/j.shpsc.2011.07.003| last1 = Stegenga | first1 = J }}
19. ^{{cite journal|doi=10.1086/341855|title=What Evidence in Evidence‐Based Medicine?|journal=Philosophy of Science|volume=69|pages=S316–S330|year=2002|last1=Worrall|first1=John}}
20. ^{{cite journal|doi=10.1017/s1745855207005029|title=Are RCTs the Gold Standard?|journal=Biosocieties|volume=2|pages=11–20|year=2007|last1=Cartwright|first1=Nancy}}

Bibliography

{{refbegin}}
  • {{cite journal|last1=Burns|first1=Patricia B.|last2=Rohrich|first2=Rod J.|last3=Chung|first3=Kevin C.|title=The Levels of Evidence and Their Role in Evidence-Based Medicine|journal=Plastic and Reconstructive Surgery|date=July 2011|volume=128|issue=1|pages=305–310|doi=10.1097/PRS.0b013e318219c171|pmc=3124652|ref={{harvid|Burns el al|2011}}|pmid=21701348}}
{{refend}}

External links

  • Evidence levels with explanations – entry in the Centre for Evidence-Based Medicine
  • Evidence-based medicine resources page – with a diagram showing different levels of evidence forming a pyramid
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3 : Evidence-based practices|Research|Clinical research

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