Clinical Practice Guidelines Antenatal Care — Module II

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10.11Process of the systematic literature reviews
Search strategies
Appraisal of the evidence

D Review of the evidence

The NICE 2008 guidelines Antenatal Care. Routine Care for the Healthy Pregnant Woman were used as the reference guidelines for this project based on their quality as assessed using the AGREE instrument. The review methodology employed by NICE is outlined in Section 1.6 of the NICE guidelines. For these Guidelines, separate systematic literature reviews were conducted for each clinical chapter. For most clinical areas relevant research questions had been considered in the NICE guidelines. The studies identified by NICE were included in the evidence tables and regraded according to the NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines (2009). Searches were then conducted to bring the literature review up to date. This appendix provides a brief summary of this process. The full evidence tables and evidence statements are included in the Technical Report.

10.11Process of the systematic literature reviews

Research questions

For each clinical topic, research questions were developed by the EAC based on the relevant research questions used in the NICE guidelines. The groups contracted to undertake reviews of the evidence related to these questions used a systematic method of literature searching and selection.

Search strategies

Searches were conducted in Medline, EMBASE, PsycInfo, Informit, Australian Medical Index and the Cochrane Database of Systematic Reviews. Search terms were searched for as keywords, exploded where possible, and as free text within the title and/or abstract, in the EMBASE and Medline databases, with modifications to suit the keywords and descriptors of other search platforms. The reference lists of included papers were reviewed to identify any peer-reviewed evidence that may have been missed in the literature search.

Appraisal of the evidence

Abstracts of studies within the review period and in English were reviewed. Exclusion criteria included:

already included in NICE guidelines;

not specific to target population (eg specific to non-pregnant women or high-risk women only);

does not answer research question;

does not meet criteria for grading (eg no outcomes reported or high risk of bias); and

narrative review or opinion paper (editorial, letter, comment).

Evidence included in the reviews was graded as per NHMRC designations (see Table D1).

Table D1: Designations of levels of evidence according to type of research question

Level	Intervention	Diagnostic accuracy	Prognosis	Aetiology	Screening intervention
I	Systematic review of level II studies	A systematic review of level II studies	A systematic review of level II studies	A systematic review of level II studies	A systematic review of level II studies
II	A randomised controlled trial	A study of test accuracy with an independent, blinded comparison with a valid reference standard, among consecutive persons with a defined clinical presentation	A prospective cohort study	A prospective cohort study	A randomised controlled trial
III-1	Pseudo-randomised trial	A study of test accuracy with independent, blinded comparison with a valid reference standard, among non-consecutive persons with a defined clinical presentation	All or none	All or none	Pseudo-randomised controlled trial (ie alternate allocation or some other method)
III-2	A comparative study with concurrent controls: • Non-randomised experimental trial • Cohort study • Case-control study • Interrupted time series with control group	A comparison with reference standard that does not meet the criteria required for level II and III-1 evidence	Analysis of prognostic factors amongst persons in a single arm of a randomised controlled trial	A retrospective cohort study	A comparative study with concurrent controls: ▪ Non-randomised, experimental trial ▪ Cohort study ▪ Case-control study
III-3	A comparative study without concurrent controls: ▪ Historical control study ▪ Two or more single arm study ▪ Interrupted time series without parallel control	Diagnostic case-control study	A retrospective cohort study	A case-control study	A comparative study without concurrent controls: Historical control study Two or more single arm study
IV	Case series with either post-test or pre-test/post-test outcomes	Study of diagnostic yield (no reference standard)	Case series, or cohort study of persons at different stages of disease	A cross-sectional study or case series	Case series

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

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