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Table 1 Methodological characteristics

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


Category/sub category


Methodological characteristics: features relating to how evidence is gathered, appraised and recommendations developed


Structuring the search



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 **


Searching for the evidence



Explicit methodology exists

A systematic search strategy (e.g., a systematic literature review) for gathering the evidence is described


Minimum no. of databases

A minimum no. of databases is specified which need to be included in the search strategy


Types of evidence gathered



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



Appraising the evidence



1st tier (individual study level)

Evidence is appraised at the individual study level


2nd tier (as a body of evidence e.g., systematic review)

Evidence is appraised as a total body (i.e., systematic review)


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.)


Explicit criteria for appraising the evidence



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)


Formulating recommendations



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


Guidance on wording of recommendations

Guidance is provided on how recommendations should be worded to provide clear, unambiguous recommendations


Patient important outcomes considered

Patient important outcomes are explicitly considered in the recommendation formulation stage


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


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


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.