WHO guidelines and the GRC · Applicant submits AD to Secretariat GRC *Evaluation and discussion...
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WHO guidelines and the Guidelines Review Committee Dr Faith McLellan
Transcript of WHO guidelines and the GRC · Applicant submits AD to Secretariat GRC *Evaluation and discussion...
WHO guidelines and the Guidelines Review Committee
Dr Faith McLellan
The Problem
WHO guidelines: not transparent, not evidence based↓ Systematic reviews↓ Transparency about judgements↑ Expert opinion↓ Adaptation of global guidelines to end
users' needs↔ Tension between time taken and when
advice needed↓ Resources
Oxman et al, Lancet 2007;369:1883-9
WHO response
GRCStandards for:
Reporting ProcessesUse of evidence
Revised WHO handbook for guidelinesDifferent types of documents for different purposes
Guideline types
EmergencyResponse to acute need, evidence informed, limited consultation, short use-by date
Standard /focusedLimited topic area, 10-20 'questions', evidence-based, 1 guideline group meeting
ComprehensiveDisease/policy area, evidence-based, 3-4 meetings
TextbooksJoint guidelines
What is a WHO guideline?
"Guidelines are recommendations intended to assist providers and recipients of health care and other stakeholders to make informed decisions. Recommendations may relate to clinical interventions, public health activities, or government policies."
WHO 2003, 2007
But what is it, really?YES: Clinical and public health interventionsNO: Standards (eg pharmacopoeia, food), standard operating procedures, evidence synthesis without recommendations, 'how to' manuals UNCLEAR: compilations of clinical information without clear recommendationsIN ANY CASE: The name is irrelevant
WHO Guidelines Production ProcessGuidelines Review Committee
A WHO Department decides to produce a guideline
Initial publication approvalADG/DGO
Final approval by GRC (see flow chart)
Beginning End
Relevant approvals are obtained (ADG or DGO)
The guideline is produced by the WHO Department (i.e. from a few months to 2/3 years time frame)
GRC SecretariatThroughout the process of production of a guideline,
the WHO Department can access the resources provided by the GRC Secretariat.
Advice and support from members of
the GRC
Advice and support from external
experts on guideline
production
Advice and support from WHO
Collaborating Centres
Advice and support from GRC through
WHO list of technical expert
Advice and support from the GRC Secretariat
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Initial approval by GRC (see flow chart)
Application Document (2-4 pages) Index• Copy of the Development of health information product form approved• Type of guideline and Scope • Target audience• Budget•Group members•Proposed outputs, products including translations• Plan for summarising and presenting the evidence, including external technical support• Peer review plan •Implementation plan (linkage with a project, if exists)
Initial approval flow-chart for WHO guidelines
1. Application Document (AD): 2-4 pages (see index proposed)
2. Applicant submits AD to Secretariat GRC
3. GRC reviews AD *
4. GRC meets with Applicant and discusses comments/questions *
6. Applicant reviews AD
9. Approval report is sent to Applicant, cc to relevant Director & ADG
If changes are requested, the AD should be resubmitted to GRC for approval.
8. GRC produces approval report (1 page)
If AD is approved
7. Applicant submits AD to Secretariat GRC
* Evaluation and discussion could require a meeting with the GRC and some technical support from GRC Secretariat. Methodological support to the group for framing, formulating the questions and revising the evidence could be offered.
5. GRC makes written comments/recommendations (1-2 pages)
10. The Applicant is ready to start the process of development of the guideline!
Completed Guideline Document (2-3 pages) Index• Copy of the GRC initial approval of guideline development process• Scope • Summary of DOI from group members• Reference to evidence summaries • Response to peer review • Implementation plan (linkage with a project, if exists)• Plan for update
Final approval flow-chart for WHO guidelines
1. Completed guideline (CG) plus 2-3 pages (see index proposed)
2. Applicant submits CG to Secretariat GRC
3. GRC reviews CG *
4. GRC meets with Applicant and discusses comments/questions *
6. Applicant reviews CG
9. Approval report is sent to Applicant, cc to relevant Director & ADG
If changes are requested, the CG should be resubmitted to GRC for approval.
8. GRC produces approval report (1 page)
If CG is approved
7. Applicant submits CG to Secretariat GRC
* Evaluation and discussion could require a meeting with the GRC and some technical support from GRC Secretariat. Methodological support to the group for framing, formulating the questions and revising the evidence could be offered as methodological support.
5. GRC makes written comments/recommendations (1-2 pages)
10. The Applicant is ready to send the guideline for usual approval (ADG, RD or DGO, as appropriate)
WHO Standards for guidelines
Reporting, process and use of evidence
1. Scoping the document: reasons for choosing the topic, problems with existing guidelines, variations and gaps,
2. Group composition (or consultations)
3. Conflict of interest
4. Formulations of the questions and choice of the relevant outcomes
5. Evidence retrieval, evaluation and synthesis (balance sheet, evidence table)
6. Benefit/risk profile: integrating evidence with values and preferences, equity and costs
7. Formulation of the recommendations
8. Implementation and evaluation of impact
9. Research needs or areas of further research
10. Peer-review process and updating
Title, responsible person, WHO Department- responsible of the clearance process, WHO Departments involved, CC involved,
Standards for evidence: GRADE system
Reporting standard and process
Reporting standard and process
Conflict of interest sample
Standards for evidence
PracticalitiesSynthesis of all available evidenceFormal assessment of quality of evidenceEvidence summaries for group meetings using standard template
Practicalities, cont'd
Consideration of resource use and costsLink evidence to recommendations, explaining reasons for judgements
System for assessing evidence for interventions: GRADE (Grading of Recommendations Assessment, Development and Evaluation)
Quality of evidence
The extent to which one can be confident that an estimate of effect or association is correct. Suggested categories:
HighModerateLowVery low
Quality of evidence
QUESTION: Should active management of the third stage of labour be used by skilled providers for all women to prevent postpartum hemorrhage (PPH)?
7.7low quality++oo
min 41 (26.5, 90.1)max 73 (43.3, 225.5)
0.33 (0.21, 0.51)
min 1.5% (0.6-2.4)max 3.2% (2.0-4.4)
31583126nonesome uncertainty about directness4,5
-1
no important inconsistency
serious limitation2
,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 1000 ml
6.3low quality++oo
min 8 (6.7, 11.2)max 16 (11.7, 24.7)
0.38 (0.32, 0.46)
min 8.3% (6.3, 10.3) max 17.9% (15.3, 20.5)
31583126nonesome uncertainty about directness4,5
-1
no important inconsistency
serious limitation2
,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 500 ml
6.4-----------0
Admission to intensive care unit
8.5-----------0
Maternal deaths
Benefits:
NNT(95%CI
)
Relative risk
(95%CI)
Baseline Risk
(95%CI)
Standard procedures
Active management
Other considera
tions
Directness
Consistency
LimitationsDesign
No of studies (Ref)
ImportanceQuality
EffectNo of patients
Summary of findingsQuality assessment
QUESTION: Should active management of the third stage of labour be used by skilled providers for all women to prevent postpartum hemorrhage (PPH)?
7.7low quality++oo
min 41 (26.5, 90.1)max 73 (43.3, 225.5)
0.33 (0.21, 0.51)
min 1.5% (0.6-2.4)max 3.2% (2.0-4.4)
31583126nonesome uncertainty about directness4,5
-1
no important inconsistency
serious limitation2
,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 1000 ml
6.3low quality++oo
min 8 (6.7, 11.2)max 16 (11.7, 24.7)
0.38 (0.32, 0.46)
min 8.3% (6.3, 10.3) max 17.9% (15.3, 20.5)
31583126nonesome uncertainty about directness4,5
-1
no important inconsistency
serious limitation2
,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 500 ml
6.4-----------0
Admission to intensive care unit
8.5-----------0
Maternal deaths
Benefits:
NNT(95%CI
)
Relative risk
(95%CI)
Baseline Risk
(95%CI)
Standard procedures
Active management
Other considera
tions
Directness
Consistency
LimitationsDesign
No of studies (Ref)
ImportanceQuality
EffectNo of patients
Summary of findingsQuality assessment
QUESTION: Should active management of the third stage of labour be used by skilled providers for all women to prevent postpartum hemorrhage (PPH)?
7.7low quality++oo
min 41 (26.5, 90.1)max 73 (43.3, 225.5)
0.33 (0.21, 0.51)
min 1.5% (0.6-2.4)max 3.2% (2.0-4.4)
31583126nonesome uncertainty about directness4,5
-1
no important inconsistency
serious limitation2
,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 1000 ml
6.3low quality++oo
min 8 (6.7, 11.2)max 16 (11.7, 24.7)
0.38 (0.32, 0.46)
min 8.3% (6.3, 10.3) max 17.9% (15.3, 20.5)
31583126nonesome uncertainty about directness4,
5
-1
no important inconsistency
serious limitation2,3,17
-1
RCT4PW 001
Ad 97Br 88Du 90Hi 98
Blood loss ≥ 500 ml
6.4-----------0
Admission to intensive care unit
8.5-----------0
Maternal deaths
Benefits:
NNT(95%CI
)
Relative risk
(95%CI)
Baseline Risk
(95%CI)
Standard procedures
Active management
Other considera
tions
Directness
Consistency
LimitationsDesign
No of studies (Ref)
ImportanceQuality
EffectNo of patients
Summary of findingsQuality assessment
Recommendations versus evidence
Recommendations are judgementsQuality of evidenceTrade off between benefits and harmsCostsValues and preferences
Why bother about grading?
People draw conclusions about thequality of evidencestrength of recommendations
Systematic and explicit approaches can help
protect against errorsresolve disagreementsfacilitate critical appraisalcommunicate information
Strength of a recommendation
Strength of a recommendationStrong vs. weak?
Strength of a recommendationStrong vs weak?
Strong/weakStrong/conditionalStrong/qualified
website
http://intranet.who.int/homes/rpc/grc/.
For assistance, advice, and further informationGuidelines HELP CLINIC
Thursdays, 1400 to 1600, Rooms 4336 and 4341GRC Secretariat contacts:Dr Faith McLellan [email protected] Gunn Vist [email protected] Silke Walleser [email protected]
