ABSTRACT
The quality of the evidence produced by any scientific study is critically
dependent on the study design. This chapter deals with issues that should
be considered when designing studies to investigate the health outcomes
of children born following assisted reproductive technology (ART) con-
ception. The topics covered include identifying the research question(s);
design issues including whether and when it is appropriate to use a
'matched' design and choosing appropriate comparison groups; data
sources and data collection methods; sample size considerations; and ana-
lytical approaches. Examples from the literature have been included to
illustrate particular points and are not intended to provide an exhaustive
critique of all the studies that may be cited as examples of particular
methodological points.