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WHO handbook for guideline development 2nd ed [Pehme köide]

  • Formaat: Paperback / softback, 178 pages, kõrgus: 300 mm, ill
  • Ilmumisaeg: 30-Dec-2014
  • Kirjastus: World Health Organization
  • ISBN-10: 9241548967
  • ISBN-13: 9789241548960
Teised raamatud teemal:
WHO handbook for guideline development 2nd edSuurem pilt
  • Formaat: Paperback / softback, 178 pages, kõrgus: 300 mm, ill
  • Ilmumisaeg: 30-Dec-2014
  • Kirjastus: World Health Organization
  • ISBN-10: 9241548967
  • ISBN-13: 9789241548960
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9789241548960.html
Märksõnad:
The first edition of this handbook, published in 2012, provided general guidance on the steps involved in guideline development and on GRC and WHO processes and procedures. This second edition provides additional detailed guidance on each step in guideline development, as well as two additional chapters. Chapter 5 deals with the importance of considering equity, human rights, gender and the social determinants of health in formulating recommendations. The chapter provides specific entry points for integrating these issues into each and every guideline developed by WHO. Chapter 11 describes the development of rapid advice guidelines in the context of a public health emergency, with a focus on how the standard methods of evidence review and synthesis need to be modified to produce such guidelines. This handbook provides step-by-step guidance on how to plan, develop and publish a World Health Organization (WHO) guideline. It covers the methods, processes and procedures for producing a document that meets WHO standards. It does not provide detailed technical guidance on many of the steps: this can be obtained from the references in the handbook and through references to the published scientific literature listed on WHO's Guideline Review Committee (GRC) intranet site (available to WHO staff). Additional chapters of this handbook containing detailed guidance on selected topics are also available and new chapters will continue to be added to the GRC intranet site in response to the needs of WHO guideline developers.
Foreword xi
1 Introduction
1(14)
1.1 What is a WHO guideline?
1(1)
1.2 Why does WHO develop guidelines?
1(1)
1.3 What principles underlie WHO guidelines?
1(1)
1.4 What is the aim of this handbook?
2(1)
1.5 For whom Is this handbook Intended?
3(1)
1.6 What is in this handbook?
3(1)
1.7 Types of WHO guidelines
3(6)
1.7.1 Standard guidelines
6(1)
1.7.2 Consolidated guidelines
6(1)
1.7.3 Interim guidelines
7(1)
1.7.4 Guidelines in response to an emergency or urgent need
8(1)
1.8 Additional types of guidelines produced by WHO
9(2)
1.8.1 Guidelines developed in collaboration with external organizations
9(1)
1.8.2 Guidelines developed by external organizations
10(1)
1.8.3 Adaptation of existing WHO guidelines
10(1)
1.9 Information products that are not considered guidelines
11(1)
1.10 The Guideline Review Committee
11(2)
1.10.1 Terms of reference of the GRC
12(1)
1.10.2 The GRC Secretariat
13(1)
1.11 References
13(2)
2 Planning guidelines
15(8)
2.1 Is this guideline really needed?
15(1)
2.1.1 Who wants the guideline?
15(1)
2.1.2 Should WHO be the organization to produce this guideline?
15(1)
2.1.3 Do guidelines on the topic already exist?
16(1)
2.2 What purpose and audience does the guideline serve?
16(1)
2.2.1 What will the guideline achieve?
16(1)
2.2.2 What are the specific objectives of the guideline?
16(1)
2.2.3 Who is the target audience?
17(1)
2.2.4 Who are the recipients of the interventions?
17(1)
2.3 When Is the guideline needed?
17(1)
2.3.1 Why now?
17(1)
2.3.2 When is the guideline needed?
17(1)
2.3.3 Is the guideline a response to a situation calling for urgent advice?
18(1)
2.4 Will the recommendations in the guideline be implemented?
18(1)
2.4.1 Are the guideline and its implementation within the relevant programme's work area and budget?
18(1)
2.4.2 Is a process for disseminating and implementing the recommendations in place?
18(1)
2.5 Who should be Involved In developing a guideline?
19(1)
2.5.1 Do you have your director's agreement?
19(1)
2.5.2 What WHO departments must be involved?
19(1)
2.5.3 Have you identified experts in guideline methods?
19(1)
2.6 Additional considerations
19(1)
2.6.1 Do you have the necessary resources to develop a guideline?
20(1)
2.6.2 What publication types and formats are you considering?
20(1)
2.6.3 What translations are you planning?
20(1)
2.7 Scoping the guideline
20(2)
2.7.1 How to scope the guideline
21(1)
2.8 References
22(1)
3 Contributors and their role in guideline development
23(16)
3.1 The steering group
23(1)
3.2 The guideline development group
24(4)
3.2.1 Composition of the guideline development group
25(3)
3.3 The external review group
28(1)
3.4 The systematic review team
29(4)
3.5 Other individuals and groups involved in guideline development
33(1)
3.5.1 The guideline methodologist
33(1)
3.5.2 Consultants with additional technical expertise
33(1)
3.5.3 Observers at the meeting of the guideline development group
33(1)
3.5.4 Designated writer/editor
34(1)
3.6 Funders of the guideline
34(1)
3.7 Identifying and managing conflicts of interests
34(1)
3.8 Managing an effective guideline development group meeting
35(1)
3.8.1 The role of the chair and vice-chair
35(1)
3.8.2 Decision-making in the guideline development group
35(1)
3.9 Planning an effective meeting
36(2)
3.9.1 Goals of the meeting
36(1)
3.9.2 Preparing for the meeting
36(1)
3.9.3 Roles and process at the meeting
37(1)
3.9.4 Follow-up after the meeting
37(1)
3.10 References
38(1)
4 Preparing the planning proposal
39(6)
4.1 What is a guideline planning proposal?
39(1)
4.2 What Is the purpose of the planning proposal?
39(1)
4.3 Who develops the planning proposal?
40(1)
4.4 When should the planning proposal be developed and finalized?
41(1)
4.5 Preparing the planning proposal
41(2)
4.6 What if there are major changes In scope or approach after the GRC has approved the planning proposal?
43(1)
4.7 For how long is an approved planning proposal in effect?
44(1)
5 Incorporating equity, human rights, gender and social determinants into guidelines
45(12)
5.1 Reflecting WHO's values in Its guidelines
45(1)
5.2 Background
45(5)
5.2.1 Equity
46(1)
5.2.2 Human rights
46(1)
5.2.3 Social determinants of health and health inequities
47(1)
5.2.4 Gender
47(1)
5.2.5 Social determinants of health
47(3)
5.3 Eight entry points for integrating equity, human rights, gender and the social determinants of health into WHO guidelines
50(1)
5.4 Incorporating equity, human rights, gender and social determinants into each step in guideline development
50(4)
5.4.1 Phase 1: planning
50(2)
5.4.2 Phase 2: development
52(1)
5.4.3 Phase 3: publishing and updating
53(1)
5.5 References
54(3)
6 Declaration and management of interests
57(20)
6.1 What is a conflict of interest?
57(1)
6.2 What types of conflicts of interest exist?
58(1)
6.3 Why is a conflict of interest important in guideline development at WHO?
59(1)
6.4 What are WHO's policies on conflicts of Interest?
59(1)
6.5 Who should complete a declaration of Interests form?
60(3)
6.6 What interests need to be disclosed?
63(1)
6.7 Collecting declarations of interests
64(1)
6.8 Assessing declarations of interest
64(3)
6.9 Managing conflicts of Interest at the Individual level
67(3)
6.9.1 Guideline development group members
67(2)
6.9.2 Peer reviewers
69(1)
6.10 Managing conflicts of interest at the group level
70(3)
6.10.1 Minimizing the risk posed by conflicts of interest when constituting guideline development groups
70(2)
6.10.2 Minimizing the risk posed by conflicts of interest during the guideline development process
72(1)
6.11 Reporting declarations of Interest in the guideline
73(1)
6.12 What sources of funding are appropriate for WHO guidelines?
74(1)
6.13 References
74(3)
7 Formulating questions and selecting outcomes
77(16)
7.1 Types of questions
77(2)
7.1.1 Background questions
77(1)
7.1.2 Foreground or key questions
78(1)
7.2 Formulating key questions in PICO format
79(4)
7.2.1 Population
79(1)
7.2.2 Intervention or exposure
80(1)
7.2.3 Comparator
81(1)
7.2.4 Outcomes
81(1)
7.2.5 Examples of key questions in PICO format
82(1)
7.3 Types of key questions
83(3)
7.4 Broadly- versus narrowly-focused key questions
86(1)
7.5 Number of key questions
87(1)
7.6 Selecting and rating outcomes
87(2)
7.7 Finalizing the key questions and priority outcomes
89(2)
Step 1 Generate an initial list of questions
89(1)
Step 2 Draft the key questions in PICO format
89(1)
Step 3 List relevant outcomes
89(1)
Step 4 Review and revise
89(2)
Step 5 Prioritize the key questions
91(1)
Step 6 Rates the outcomes
91(1)
Step 7 Finalize the key questions and the important and critical outcomes
91(1)
7.8 Analytic frameworks
91(1)
7.9 References
92(1)
8 Evidence retrieval and synthesis
93(16)
8.1 What is a systematic review?
93(1)
8.2 Identifying and evaluating existing systematic reviews
94(3)
8.2.1 Sources for existing systematic reviews
94(1)
8.2.2 Is a new systematic review needed?
95(1)
8.2.3 Evaluating the relevance and quality of existing systematic reviews
96(1)
8.3 Steps in performing a systematic review
97(6)
Step 1 Develop and finalize the key questions and the study eligibility criteria
98(1)
Step 2 Identify information sources and search for original articles
99(2)
Step 3 Select studies and abstract data
101(1)
Step 4 Assess risk of bias of the individual studies
101(1)
Step 5 Synthesize and report the results and conclusions
102(1)
Step 6 Prepare the final report of the systematic review
103(1)
8.4 Including qualitative research
103(1)
8.5 Including other types of data In the systematic review
104(1)
8.6 Updating existing systematic reviews
104(1)
8.7 How to commission a systematic review
105(1)
8.8 Systematic review quality standards
106(1)
8.9 Systematic review reporting standards
106(1)
8.10 References
106(3)
9 Evidence assessment
109(14)
9.1 What Is the "quality of the evidence"?
110(1)
9.2 What are GRADE evidence profiles?
110(1)
9.3 Who performs the quality assessment?
110(2)
9.4 What is the role of WHO staff in assessing the quality of the evidence?
112(1)
9.5 How is the quality of the body of evidence assessed for intervention studies?
112(8)
9.5.1 Five factors can lower the quality of the body of evidence for each outcome
113(6)
9.5.2 Three factors can increase the quality of the evidence from observational studies
119(1)
9.6 How Is the overall quality of the evidence determined?
120(1)
9.7 Is GRADE applicable In all situations?
121(1)
9.8 References
121(2)
10 Developing recommendations
123(10)
10.1 Factors that determine the direction and strength of recommendations
123(2)
10.2 Detailed criteria that should be considered when moving from evidence to recommendations
125(3)
10.2.1 Quality of the evidence
125(1)
10.2.2 Values and preferences
125(1)
10.2.3 Balance of benefits and harms
126(1)
10.2.4 Resource implications
126(1)
10.2.5 Priority of the problem
127(1)
10.2.6 Equity and human rights
127(1)
10.2.7 Acceptability
127(1)
10.2.8 Feasibility
128(1)
10.3 Evidence-to-recommendation tables
128(1)
10.4 The strength of the recommendation
128(2)
10.4.1 Strong recommendations
129(1)
10.4.2 Conditional or weak recommendations
129(1)
10.5 Formulating recommendations
130(1)
10.5.1 Reaching agreement on recommendations
130(1)
10.6 Writing recommendations
130(1)
10.7 When not to make recommendations
131(1)
10.8 Future research
132(1)
11 Rapid advice guidelines in the setting of a public health emergency
133(24)
11.1 What is a rapid advice guideline?
133(1)
11.2 What is a rapid review?
133(1)
11.3 What is the evidence on the validity and impact of rapid reviews and rapid advice guidelines?
134(1)
11.4 Is a rapid advice guideline needed?
134(3)
11.4.1 What is the type of emergency and the risk to public health?
135(1)
11.4.2 Is the event novel?
135(1)
11.4.3 Does uncertainty need to be urgently addressed?
136(1)
11.4.4 What is the anticipated time frame for the event?
136(1)
11.4.5 Will the rapid advice guideline be rapidly implemented?
136(1)
11.5 How is a rapid advice guideline developed?
137(4)
11.5.1 Consult the GRC Secretariat early
137(1)
11.5.2 Formulate the various groups involved in guideline development
137(3)
11.5.3 Scope the rapid advice guideline and define the key questions
140(1)
11.5.4 Prepare the planning proposal for the GRC
140(1)
11.6 How do rapid reviews compare with systematic reviews?
141(2)
11.6.1 Types of rapid reviews
141(2)
11.7 Steps in the rapid review process
143(7)
11.7.1 Select the types of evidence to be collected and identify the appropriate sources
143(1)
11.7.2 Develop search strategies
143(1)
11.7.3 Search for grey literature
144(1)
11.7.4 Common search restrictions
144(1)
11.7.5 Other strategies for identifying relevant literature
145(1)
11.7.6 Screening and study selection
146(1)
11.7.7 Use a stepwise approach with emphasis on higher levels of evidence
146(1)
11.7.8 Obtaining publications
146(1)
11.7.9 Data extraction and evidence synthesis
147(1)
11.7.10 Assess the risk of bias at the individual study level
147(1)
11.7.11 Evidence synthesis
147(1)
11.7.12 Assessing the quality of the body of evidence using GRADE
148(2)
11.8 The rapid review report
150(1)
11.9 Formulate recommendations
151(1)
11.9.1 Convene the meeting of the guideline development group
151(1)
11.9.2 Evidence to recommendations
152(1)
11.10 Draft the guideline document
152(1)
11.11 External peer review
152(1)
11.12 Implementation and the Importance of context
153(1)
11.13 Publishing
153(1)
11.14 Updating
154(1)
11.15 Guideline Review Committee processes for rapid advice guidelines
154(1)
11.16 Conclusions
155(1)
11.17 References
156(1)
12 Producing and publishing the guideline
157(8)
12.1 Guideline format
157(1)
12.2 Peer review
158(1)
12.3 The production process
159(2)
12.3.1 Writing
159(1)
12.3.2 Legal advice on proprietary products
160(1)
12.3.3 Editing and proofreading
160(1)
12.3.4 Executive clearance and approval by the Guideline Review Committee
160(1)
12.3.5 Layout
160(1)
12.3.6 Printing
161(1)
12.4 Disseminating guidelines
161(2)
12.4.1 Online publication
161(1)
12.4.2 Archiving
162(1)
12.4.3 Translations
162(1)
12.4.4 Journals
162(1)
12.4.5 Other forms of dissemination
162(1)
12.5 Updating guidelines
163(1)
12.5.1 Review-by date
163(1)
12.5.2 Updating recommendations
163(1)
12.5.3 Guidelines that are near or beyond their "review-by" date
163(1)
12.5.4 Recommendations that may be out of date
164(1)
12.6 References
164(1)
13 Adaptation, implementation and evaluation
165
13.1 Adaptation
165(1)
13.2 Implementation
166(1)
13.3 Monitoring and evaluation
166(1)
13.4 References
167