EBM (Evidence-Based Medicine)

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EBM (Evidence-Based Medicine)
http//www.usaco.co.jp/EBMR.html

• EBM?? Evidenc-Based Medicine(???????????)????????
  ??????????????????????????????????????????????????
  ???????????????EBM????????????? (the Agency for
  health Care Policy Research, the American
  college of Physiciaians, the British medical
  Association?the Cochrane Collaboration)???????????
  ??????(Oxford University?Michigan State
  University??)???????EMB???????????????

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EBM????

• EBM?????????????????????????????
• 1.???????????????????
• 2.?????????????????(?????)???????
• ?????????EBMR(The Cochrane Database of
  Systematic Reviews?Best Evidence)???????
• 3.?????????(?????)??????????????
• 4.?????????????????????
• 5.?????????????

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Evidence-Based Medicine Reviews(EBMR) ???

• 1.The Cochrane Database of Systematic Reviews
  CDSR
• The Cochrane Database of Systematic
  Reviews(CDSR)?????????(The Cochrane
  Collaboration)????? ?????????45???????????????????
  ??????????Review(?????????? ??)?Protocol(???????
  ?)??????????

??????????1992???????????????? ??????????????????
????????????????????????(randomized controlled
trialRCT)?????????Clinical Trail?????????????(sy
stematic review???????????? ????????)????????????
?????????????????????????????????? ???????????
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Evidence-Based Medicine Reviews(EBMR)

• 1.The Cochrane Database of Systematic Reviews
  CDSR

???????????????????????????? 1.
??????????????????????? 2. MEDLINE?EMBASE?BIOSI
S?????????????????????????????????????????? 3.
??????????????????????????????? 4.
??????????????????????? 5. ??????????????? 6.
?????????????
2. Database of Abstracts of Reviews of
Effectiveness DARE ????????The National Health
ServicesCentre for Reviews and Dissemination
(NHS CRD) ???????????????????????????????????????
???????????
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Evidence-Based Medicine Reviews(EBMR)

• 3.Best Evidence
• ACP Journal Club?Evidence-Based
  Medicine?????????????????????????????????????????(
  tructured abstract)????1??????????????????????????
  ??????????????????????????????????????????????????
  ??????????????

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EBM

• Evidence-Based Medicine
• ???????????
• ??????????????????????????????????EBNEvidence-B
  ased Nursing

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???????????????

• ? ???????? (RCT Randomized Control Trial)
• ? ??????????????????? (??????)
• ? ??????(Case-control Study)
• ? ??????????????????

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???????????????(2)

• ? ???????? (RCT Randomized Control Trial)
• ?a???RCT???????? (Meta-analysis)
• ?b?????1??RCT

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EBM????????

• STEP1 ????????? (??????????)
• STEP2 ??????????????? (?????)???
• STEP3 ??(?????)????? ?????????
  (critical appraisal)
• STEP4 ??????????? ??????

IT???
???
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??????????????????????????

• International Committee of Medical Journal
  EditorsUniform Requirements for Manuscripts
  submitted to biomedical JournalsAnn. Intern.
  Med. 1988, 108 258-265

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???????????????

• Bailer JC, Mosteller F Guidelines for
  Statistical Reporting in Articles for Medical
  Journals - amplications and explanations.Ann.
  Intern. Med. 1988, 108 266-273
• ????????????????????????????????????????????????3
  ?????????,??? 1992,175-82
• ??????????(??????????)?23???????????????????????p
  p.668-677,????

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??????????????

• 1)Statistical Analysis Methods????Statistical
  Analysis??sub-section???
• (1)????????????meanSD or meanSE????????????
  ????????percentile median 25?75?range
• (2)????(????)?????????????????
• (3)??????????(one-tailed)?????(two-tailed)
• (4)??????????????

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??????????????(?)

• 2)Results???????????????????????????????????????
  ???????
• 3)Tables and Figures?????????(????)??????????????
  ??????????????????(??????????????)???
• ??1)Describe Statistical methods with enough
  detail to enable a knowledgeable reader with
  access to the original data to verify the
  reported results.12)Put general description of
  methods in the Methods section, specify the
  statistical methods used to analyze them.
  15)Define statistical terms, abbreviations, and
  most symbols.

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??????????

• ????????p value???????????????????????????????????
  ??????????????????????????????????????????????????
  (??)????????(??)?????????????????????????????
• ???????????????????????????????????????????
• ??2)When possible, quality findings and present
  them with appropriate indicators of measurement
  error or uncertainty(such as confidence
  intervals)3)Avoid sole reliance on statistical
  hypothesis testing, such as the use of P values,
  which fails to convey important quantitative
  information.

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????????????

• ???????????????????????????????????
• ??????????????Thirty consecutive patients with
  liver cirrhosis who visited our outpatients
  clinic were recruited for this study...
• ????????????????study protocol??????(??)?eligibili
  ty criteria (inclusion exclusion)?????????
• ??4)Discussion eligibility of experimental
  subjects.

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??????????

• ???????????????????????????????????????????????
  ????????????????????????
• ???????????????????????(??)????????????????????
  ?????????(????????????????)????(???????)????
  ??????????????????????????????????????
• ??5)Give details about randomization

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????????????

• ?????????????????????????????
• ??????????????????????????????????????????????????
  ????(?????????????)
• ????????????????????????????????????
• ??8)Give numbers of observations. 9)Report
  losses to observation (such as dropouts
  from a clinical trial).

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???

• ?????????????????????????????????textbook?????
  ?10)References for study design and statistical
  methods should be to standard works (with pages
  stated) when possible, rather than to papers
  where designs or methods were originally
  reported.
• ?????????????????????????11)Special any
  general-use computer programs used
• ???????????????14)Avoid non-technical uses of
  technical terms in statistics, such as
  random(which implies a randomizing device)
  normal,significant,correlation and sample.

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EBM???????? Evidence Based Medicine and
Meta-analysis

• ?? ??
• ?????????????? ?????
• Masayuki HONDA
• Department of Medical Informatics, Nagasaki
  University Hospital

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?????????????????
???????????????(Ver4.1/2001.4.24)

• ????????????????????????,???????????????????????
  ?????????????.
• ?????????,??????????????????????????evidence-ba
  sed medicine????????????.???,?????????????????????
  ?,??????????.

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?????????????????
???????????????(Ver4.1/2001.4.24)

• ?????(???)1.?????????????(???)???????
• 2.???????????
• 3.??????????????????,???(research
  question)???????
• 4.????????,????????
• 5.??????????,??????????????????????,??????????????
  ???(included study)????????(excluded study)??????
• 6.???????????????,???????????????????????????(abst
  ract form)?????????????

?????????1.???? 1)????????????????
2)?????????????????????? 2.????
1)????????? 2)?????????? 3.????????????,??????
???????????????????,?????????????????????????????
??????????????????.
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?????????????????
???????????????(Ver4.1/2001.4.24)

• ?????(???)
• 7.???????????,?????????????(abstract table)???
• 8.??????,??????????????,????????????????????(??,?
  ???,???,?,?,???)??????
• 9.????????????????????????????????????????(?????)?
  ??????,?????,???????????????????
• 10.?????????????????????
• 11.???????????????????????????????????????????????
  ??.
• 12.??????????????????,??????????????????
• 13.?????,?????????????????(????????????
  ????????????????????)????
• 14.?????3???????????????,?????????????????

?1
?2
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1.????????????????????????????????????????????
???????.2.???????,???????????????????????????????
????????????????.3.???????,??????????????????????
???????????????.4.???????????,???????????????????
????,????????????????????????????.
?1 ????????????????????
? ?
????
????
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?.????????????/????????.??????????????????
?.??????????????.???????(????????????????)?.????
(????????????)????.???????????,??????????????.
?2 ??????????????????????
?
???????
?????????
? ?
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??????????
??????????????????????????????????overview,
pooling, combining????????????????????????????????
?????????????????????????????????????????????????
?(??)
??????????????????????????????????????????????????
??????
???????? ?????????????????????????????????
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?????????????????????? ???
???????????????????(Points to Consider)????????
??????????????,?????????????????????( Committee
for Proprietary Medical Products(2001))

• ??
• ????????????????????????.
• ????????????????????????????????????????.
• ?????????????,???????????????.
• ??????????????,???????????????(???)?????
• ???????????????.
• ????,?????????????.

• ???????????????????
• ??????????????? ??????,
• ??????????,
• ???????????????????????,
• ?????,???????????????,????????????????,
• ?????????????????????????????

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??????? ????
?????????????

• ???????(????)?????????????????????????????????????
  ????????
• ?????????????????????????????????
• ?????????????(??????????????????????????????????)?
  ?????????????????????
• ??????????????????????????????????????????????????
  ???????????????????????????????????????????????
• ??????????????????
• ???????????????????????????????

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??????(Publication bias) ???(1)
?????????(?????)
????????????
??????????

• ?????????????
• ???????(?????????)
• ??????(??????????????)
• ??????
• ????????
• ????
• ????(GCP?????)
• ???
• ?????????
• ??????

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??????(Publication bias) ???(2)

• ??17?7????????????????????????????????????????????
  ?????(11?)????????
• UMIN(????????????)???????? (?????????????????17?
  5?????????????)
• UMIN???????(??????2005.2.2??)

????????????????????????? ??????????????????????
????(?????)???????????? ????????????????? ????????
?????????? ?????????? ? ?????????
????????????????????????????????????? ????????????
?????????????? ??????????
????????????????????
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??????????????????????

• ????????????????2??????????(?2?????????????????
  ??????????????)
• ??????????????????????????????????(????)????

• ??????????????
• ?????

• ???????
• ???????(?????????)
• ??????(??????????????)
• ??????
• ????????
• ????
• ????(GCP?????)
• ???
• ?????????
• ??????

??????? ???? ???? ?????? ???? ????
???????????(?????)
????????????
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?????????????(1)

• MAL(meta-analysis of the literature)
  ??????(?????????????)
• MAP(meta-analysis of individual patient
  data)??????(?????????????????)

• MAP???
• ????????????????
• ??????????????????????????????????????????????????
  ?????????

MAP????(??2002) 1)????????????????????????????????
?????????????????????????? 2)?????????????????????
?????(????,?????????)????????-?????L????????. 3)??
????????,????????????????????????????????????????
?.
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?????????????(2)
MAP????UMIN????????????? ??????????? ????????
??????? ????????
Cres?? ?????????????
?????????????????????????(????????????)?????????
???????????????????????? ????????????????
??????????? ??????????????????????
???????????????? ??????????????????????
??????????? ????????? ???????
?????????????
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CReS?? ????????????
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? ? ?

• EBM???Sackett(1997)???????????????????????????????
  ?????????????????????????????
• ???????????(systematic review)????????????????????
  ???????????????????
• EBM???????????????????????????????????????????????
  ??????????
• ??????????????????????????????????????????????????
  ???????????
• ??????????????????????????????????????????????????
  ??????????????????????????????????????????????????
  ???????