Joan.Vlayen | KCE

Process Book

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1. Introduction

1. Introduction

1.1. What is GRADE?

1.2. Limitations of GRADE

1.3. Steps in the process

2. Building a search question

2. Framing the question

3. Deciding on important outcomes

3. Searching electronic sources

3.1 Sources of biomedical literature

3.1. General approach

3.2 Sources of economic literature

3.2. Perspective of outcomes

3.3 Sources of clinical practice guidelines

3.3. Before and after literature review

3.4 Sources of ongoing clinical trials

3.4. Implications of the classification

3.5. Expert involvement

3.5. Sources of grey literature

3.6 Building a search strategy

3.6. Use of surrogates

3.6.1 Search tools

3.6.2 Search limits

3.6.3. Search filters

3.7 Documenting a search strategy

3.7. Clinical decision threshold and minimally important difference

3.8. Adverse effects

4. Searching supplementary sources

4. Summarizing the evidence

5. Rating the quality of evidence

5. Searching for evidence on adverse effects

5.1. Introduction

5.1.1. Four levels of evidence

5.1.2. Overall quality of evidence

5.1.3. GRADE and meta-analysis

5.2. Study limitations, risk of bias

5.2.1. Risk of bias assessment of individual studies should be done using a validated assessment tool

5.2.2. Moving from individual risk of bias to a judgment about rating down for risk of bias across a body of evidence

5.3. Inconsistency

5.3.1. Heterogeneity and inconsistency

5.3.2. Judging heterogeneity and inconsistency

5.3.3. Other considerations

5.4. Indirectness

5.5. Imprecision

5.5.1. Clinical decision threshold and minimally important difference

5.5.1.1. Categorical outcomes

5.5.1.2. Continuous outcomes

5.5.2. Application and examples

5.5.3. Relative versus absolute reductions

5.5.4. Dealing with fragility: Optimal Information Size (OIS)

5.5.5. Low event rates with large sample size: an exception to the need for OIS

5.6. Publication bias

5.7. Reasons to upgrade studies

5.7.1. Large magnitude of effect

5.7.3. Dose-response gradient

6. Recommendations

6.1. Four key factors influence the strength of a recommendation

6.2. Wording of a recommendation

7. GRADE and diagnostic testing

7. Quality assessment of studies

7.2. Critical appraisal of randomized controlled trials for interventions

7.3. Critical appraisal of diagnostic accuracy studies

7.4. Critical appraisal of observational studies

7.5. Critical appraisal of guidelines

8. Data extraction

ADAPTE: To use or not to use?

Evidence tables

GRADE evidence profiles

GUIDELINE DEVELOPMENT: PRINCIPLES (GCP)

SEARCH FOR EVIDENCE (GCP - HTA)

The ADAPTE methodology