Clinical Practice Guidelines Antenatal Care — Module II



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Grading of the evidence


Grading of the body of evidence involved:

review of the evidence base, including the number of studies, level of evidence and quality of studies (eg risk of bias), and consistency across studies;

examination of the effect size, the relevance of the evidence base to the research question and whether the risks and benefits had been considered in terms of clinical impact; and

judgement by members of the EAC of the generalisability of the body of evidence to the target population for the Guidelines and the applicability of the body of evidence to the Australian healthcare context, taking into account feasibility issues (workforce, geographical distance, cost) and existing health care systems.

The Evidence Statement Form/Matrix (adapted from NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines [2009]) was used for each research question addressed. The form was used as the basis of discussion regarding the key components, which were rated according to the matrix shown in Table D2. Conflicts of interest (eg where an EAC member was author of evidence under consideration) were declared at the commencement of discussion of each topic. Barriers to implementing the recommendations and support required for successful uptake of the Guidelines, were noted on the Form.

Table D2: Components of body of evidence considered when grading each recommendation



Evidence base

A

One or more level I studies with a low risk of bias or several level II studies with low risk of bias




B

One or two level II studies with a low risk of bias or systematic review/several level III studies with a low risk of bias




C

One or two level III studies with a low risk of bias or level I or II studies with a moderate risk of bias




D

Level IV studies or level I to III studies/systematic review with a high risk of bias

Consistency

A

All studies consistent




B

Most studies consistent and inconsistency can be explained




C

Some inconsistency, reflecting genuine uncertainty around question




D

Evidence in inconsistent




NA

Not Applicable – one study only

Clinical Impact

A

Very large




B

Moderate




C

Slight




D

Restricted




UD

Unable to be determined

Generalisability

A

Evidence directly generalisable to target population




B

Evidence directly generalisable to target population with some caveats




C

Evidence not directly generalisable to target population but could be sensibly applied




D

Evidence not directly generalisable to target population and hard to judge whether it is sensible to apply

Applicability

A

Evidence directly applicable to Australian healthcare context




B

Evidence applicable to Australian healthcare context with few caveats




C

Evidence probably applicable to Australian healthcare context with some caveats




D

Evidence not applicable to Australian healthcare context

Source: NHMRC Levels of Evidence and Grades of Recommendations for Developers of Guidelines (NHMRC 2009).


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