Skip to main content

Table 1 Methodological characteristics

From: Guidelines for guideline developers: a systematic review of grading systems for medical tests

No. Category/sub category Description
Methodological characteristics: features relating to how evidence is gathered, appraised and recommendations developed
1 Structuring the search  
1a-g Preparatory steps prior to evidence collection Preparatory steps are clearly outlined prior to beginning the literature search. Preparatory steps defined as any step that defines the remit of the guideline, such as scoping of the literature*, identify key question(s), define outcomes of importance, create a clinical scenario/care pathway and/or analytical framework **
2 Searching for the evidence  
2a Explicit methodology exists A systematic search strategy (e.g., a systematic literature review) for gathering the evidence is described
2b Minimum no. of databases A minimum no. of databases is specified which need to be included in the search strategy
3 Types of evidence gathered  
3a-c Accuracy data The search for evidence extends beyond test accuracy to include other evidence such as patient important outcomes (e.g., quality of life), cost and resource, legal and ethical issues etc.
Patient important outcome data
Other
4 Appraising the evidence  
4a 1st tier (individual study level) Evidence is appraised at the individual study level
4b 2nd tier (as a body of evidence e.g., systematic review) Evidence is appraised as a total body (i.e., systematic review)
4c 3rd tier (combining different bodies of evidence) Different bodies of evidence are brought together and appraised (i.e., combining evidence derived from different systematic reviews or other forms of evidence reports on cost, quality of life measures etc.)
5 Explicit criteria for appraising the evidence  
5a-c 1 tier (individual study) Criteria used to appraise the evidence at each tier is explicit. For instance, is there a quality checklist used, what are the levels of evidence, is appraisal done in duplicate by different reviewers, is there an evidence table compiled, what other criteria are used to assess evidence quality
2 tier (as a body of evidence e.g., systematic review)
3 tier (combing different bodies of evidence)
6 Formulating recommendations  
6a Methods on how recommendations are derived Explicit method(s) exist to formulate the recommendations and how final decisions are arrived at. Methods include for example, a voting system, formal consensus techniques (e.g., Delphi, Glaser techniques). Areas of disagreement and methods of resolving them should be specified
6b Guidance on wording of recommendations Guidance is provided on how recommendations should be worded to provide clear, unambiguous recommendations
6c Patient important outcomes considered Patient important outcomes are explicitly considered in the recommendation formulation stage
6d A method exists to translate indirect evidence into recommendations An explicit methodology exists on how indirect evidence (i.e., accuracy data) is translated into recommendations
6e Applicability of recommendations considered Potential organizational barriers and cost implications of recommendations are considered. For instance, applying the recommendations may require changes in the current organization of care within a service or a clinic which may be a barrier to using them in daily practice. Recommendations may require additional resources in order to be applied. For example, there may be a need for specialized staff, new equipment, or an expensive drug treatment
Total 6 categories/23 subcategories  
  1. *Scoping of the literature is defined as a very broad search of the literature relevant to the condition that is to be the topic of the guideline. No attempt is made to focus on specific questions at this stage. The intention is only to establish the general extent of the literature in the clinical area to see if there is likely to be sufficient good quality evidence to make evidence based guideline feasible.
  2. **A clinical scenario is defined as a scenario that addresses the intended use of test including setting e.g., primary or specialist care; how test will be applied e.g., screening, diagnosis; who will be tested e.g., general population or high risk groups.
  3. **Care pathway is defined as the diagnostic sequences, treatments, monitoring, retreatment, treatment for side effects and complications that are part of the test-treatment pathway. A flow chart or other diagram can be used to illustrate the pathway.
  4. **Analytical framework is defined as an overarching framework showing linkages of the clinical scenario, the intermediate and health outcomes of interest, and the key questions to be addressed.