Very large treatment effects in randomised trials as an empirical marker to indicate whether subsequent trials are necessary: meta-epidemiological assessment.

ABSTRACT:

Objective

 To examine whether a very large effect (VLE; defined as a relative risk of ≤0.2 or ≥5) in a randomised trial could be an empirical marker that subsequent trials are unnecessary.

Design

 Meta-epidemiological assessment of existing published data on randomised trials.

Data sources

 Cochrane Database of Systematic Reviews (2010, issue 7) with data on subsequent large trials updated to 2015, issue 12.

Eligibility criteria

 All binary outcome forest plots were selected, which contained an index randomised trial with a VLE that was nominally statistically significant (P<0.05), included a subsequent large randomised trial (≥200 events and ≥200 non-events) for validation of the effect, assessed a primary outcome of the review, and was not a subgroup or sensi

SUBMITTER: Nagendran M 

PROVIDER: S-EPMC5081692 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature