Appendix 2 Literature search methods

Page last updated: September 2016

Search criteria and terms

Search filters should initially be set to include only randomised trials, as follows:

a) the trial includes a randomisation procedure in its design (use Cochrane Highly Sensitive Search Strategies⁶⁴)

b) the trial contains the proposed medicine and the relevant comparator(s)

c) the trial recruits participants with characteristics that overlap with those of the target population (only apply this criterion if the medicine is listed for multiple indications, to avoid excluding potentially relevant trials).

Of these criteria, only (c) requires an element of judgment. If there is any uncertainty about whether to include or exclude a randomised trial, it is usually wiser to include it.

Use Table A2.1 to tabulate search terms based on the search criteria above and adapted to capture direct randomised trials, randomised trials required for indirect comparisons, or nonrandomised studies. Present Table A2.1 in the main body of the submission.

MeSH = medical subject headings

Ensure that the search terms for population are broad; only apply them if the proposed medicine is used for multiple indications. Do not include terms for trial outcomes in the search strategy. Exclude any identified trials that do not report on an appropriate outcome in Subsection 2.2. Include the comparator search terms for all relevant comparators.

The methods used to search the published literature are key to assessing the completeness of the overall search. Tabulate the characteristics of the search strategy as shown in Table A2.2. Where additional databases are relevant to include (eg PsycINFO for mental health literature), add these to Table A2.2.

The methodological standards for the conduct of new Cochrane Intervention Reviews are an appropriate source of guidance for performing a high-quality systematic literature search.⁶⁴

Provide a complete electronic search strategy for PubMed in an attachment to the submission. Present Table A2.2 in the main body of the submission.

^a Includes the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials and the Health Technology Assessment database

^b International Clinical Trials Registry Platform

^c Report on the details of supplementary searches, including manual checking of the references in retrieved papers, searches of the TGA dossier and searches of grey literature.