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Trials in primary care should
recruit participants that are more representative of patients seen in the community than
are in trials in secondary care. However, if the processes that
operate to determine whether a patient is included in a trial are not random,
trial participants may be skewed with respect to disease severity or other
factors such as age or social class. Although this will not bias the trial
result (internal validity), it may misrepresent the effect of the intervention
in non-trial settings (external validity). Modelling, sensitivity analysis,
and statistical estimates of uncertainty are necessary to determine the
generalisability of the trial and to particularise results to a given clinical
setting.(Lilford 1998) Primary
care provides many opportunities but is not an easy place to conduct research. Trials must
be designed and undertaken by multidisciplinary teams with expertise in both
the context of clinical practice and research methods. |