5. Keywords
• Pa:ent
centered
outcome
• Body
of
evidence
• GRADE
– The Grading of Recommendations
Assessment, Development and Evaluation
• AGREE
– The Appraisal of Guidelines for Research and
Evaluation
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7. ガイドラインの定義
Ins:tute
of
Medicine
1990
• systema:cally
developed
statements
to
assist
prac::oner
and
pa:ent
decisions
about
appropriate
health
care
for
specific
clinical
circumstances
• 特定の臨床状況での適切な判断の実現に向
けて、医療者と患者を支援するために、系統
的に作成された文書
• “Clinical
Prac:ce
Guidelines:
Direc:ons
for
a
New
Program
(
1990
)
“
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8. ガイドラインの定義：改訂
Ins:tute
of
Medicine
2011
• Clinical
Prac:ce
Guidelines
are
statements
that
include
recommenda:ons
intended
to
op:mize
pa:ent
care.
– 診療ガイドラインとは、患者ケアの最適化を目的とす
る推奨を含む文書である。
• They
are
informed
by
a
systema:c
review
of
evidence
and
an
assessment
of
the
benefits
and
harms
of
alterna:ve
care
op:ons.
– 診療ガイドラインは、エビデンスのシステマティックレ
ビューと、選択肢の益と害の評価によって作成される。
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17. 患者中心のアウトカム
• ARDSの人工呼吸療法のアウトカムは
– 28日生存率改善
cri:cal
– 28日人工呼吸器非装着日数短縮
cri:cal
– 合併症（圧損傷など）の発生率低下
important
– 酸素化の改善
not
important
– 平均気道内圧の制限
not
important
第41回集中治療医学会学術総会
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18. Body
of
Evidence
• 推奨決定のために必要なevidenceは、個々
の論文を体系的に評価する必要がある
• システマティックレビューを行ない、エビデン
ス総体（body
of
evidence）を評価する
第41回集中治療医学会学術総会
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19. GRADE
• The Grading of Recommendations Assessment,
Development and Evaluation
• 国際的なガイドライン作成手順の標準化の取
り組み
2000年から活動を開始
– 明示的で、実用的で、共通のガイドラインの推奨
作成手順を開発している
– ガイドラインに限らず、UpToDateなどでも採用
– hUp://www.gradeworkinggroup.org
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22. Critical
Outcome
Critical
Outcome
Important
Outcome
Not
High
Moderate
Low
Very
low
Summary
of
findings
&
estimate
of
effect
for
each
outcome
Systematic
review
Grade
down
Outcome
Grade
up
P
I
C
O
Randomization
increases
initial
quality
1. Risk
of
bias
2. Inconsistency
3. Indirectness
4. Imprecision
5. Publication
bias
1. Large
effect
2. Dose
response
3. Confounders
Guideline
development
Formulate
recommenda.ons:
• For
or
against
(direc:on)
• Strong
or
weak/condi:onal
(strength)
By
considering:
q Quality
of
evidence
q Balance
benefits/harms
q Values
and
preferences
Revise
if
necessary
by
considering:
q Resource
use
(cost)
Grade
overall
quality
of
evidence
across
outcomes
based
on
lowest
quality
of
critical
outcomes
Holger Schünemann, MD,PhD
• “We
recommend
using…”
Chair and Professor, Department of Clinical
• “We
suggest
using…”
Epidemiology• &“We
recommend
against
using…”
Biostatistics
• “We
第41回集中治療医学会学術総会
suggest
against
using…”
22
McMaster University, Hamilton, Canada
23. GRADE
Grading
of
Recommenda:ons
Assessment,
Development
and
Evalua:on
• 患者中心のアウトカム設定
• システマティックサーチとレビューを行う
– アウトカムごとに「バイアスのリスク（ROB)」を評価
– アウトカムごとに（可能なら）メタ分析を行う
– アウトカムごとに「エビデンスの総体（BOE)」を評価し推奨
度を決定する
• 研究ごとのまとめを「研究サマリー(SoF)」の表を作る
• 以下、推奨に向けて作業を進める
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26. Critical
Outcome
Critical
Outcome
Important
Outcome
Not
High
Moderate
Low
Very
low
Summary
of
findings
&
estimate
of
effect
for
each
outcome
Systematic
review
Grade
down
Outcome
Grade
up
P
I
C
O
Randomization
increases
initial
quality
1. Risk
of
bias
2. Inconsistency
3. Indirectness
4. Imprecision
5. Publication
bias
1. Large
effect
2. Dose
response
3. Confounders
Guideline
development
Formulate
recommenda.ons:
• For
or
against
(direc:on)
• Strong
or
weak/condi:onal
(strength)
By
considering:
q Quality
of
evidence
q Balance
benefits/harms
q Values
and
preferences
Revise
if
necessary
by
considering:
q Resource
use
(cost)
Grade
overall
quality
of
evidence
across
outcomes
based
on
lowest
quality
of
critical
outcomes
• “We
recommend
using…”
• “We
suggest
using…”
• “We
recommend
against
using…”
• “We
第41回集中治療医学会学術総会
suggest
against
using…”
26
43. Critical
Outcome
Critical
Outcome
Important
Outcome
Not
High
Moderate
Low
Very
low
Summary
of
findings
&
estimate
of
effect
for
each
outcome
Systematic
review
Grade
down
Outcome
Grade
up
P
I
C
O
Randomization
increases
initial
quality
1. Risk
of
bias
2. Inconsistency
3. Indirectness
4. Imprecision
5. Publication
bias
1. Large
effect
2. Dose
response
3. Confounders
Guideline
development
Formulate
recommenda.ons:
• For
or
against
(direc:on)
• Strong
or
weak/condi:onal
(strength)
By
considering:
q Quality
of
evidence
q Balance
benefits/harms
q Values
and
preferences
Revise
if
necessary
by
considering:
q Resource
use
(cost)
Grade
overall
quality
of
evidence
across
outcomes
based
on
lowest
quality
of
critical
outcomes
• “We
recommend
using…”
• “We
suggest
using…”
• “We
recommend
against
using…”
• “We
第41回集中治療医学会学術総会
suggest
against
using…”
43
