Form follows function: pragmatic controlled trials (PCTs) have to answer different questions and require different designs than randomized controlled trials (RCTs).
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https://hdl.handle.net/10037/6090Date
2013Type
Journal articleTidsskriftartikkel
Peer reviewed
Abstract
Aim Rising concern for demonstrated real world comparative
effectiveness has heightened interest in “pragmatic trials”
design. Pragmatic trials investigate whether the efficacy, presumed
or found in explanatory trials under ideal conditions,
can also be detected under real world conditions, i.e. effectiveness.
It is also recognized that ‘real world’ effects which
are usually addressed in public health research gain growing
interest in confirming the ‘road capability’ of results obtained
under ideal study conditions. This paper demonstrates that
studies under ideal or real world conditions use different
methods, generate different information and cannot replace
each other.
Subjects and methods The PCT design meets four requirements
of public health and of effectiveness research. It
includes all individuals who presented with the selected
condition. It classifies the included individuals according
to baseline risks. It enables plausibility controls. Finally, it
compares the outcomes resulting from specified and notspecified
interventions or treatments.
Proposal We propose a pragmatic controlled trial (PCT)
design in which patient preference and other co-factors
crucial in determining the actual effectiveness of interventional
options will not be neutralized by concealed randomization
and blinding. This design is applicable to record the
selected interventions and generated outcomes in day-to-day
health care and is capable of incorporating preference and
other participative factors into assessment of effectiveness.
Conclusions The PCT design is useful for public health research,
e.g. the effectiveness of interventions to change smoking
habits or to prevent death frombreast cancer, as well as for
comparative effectiveness research where it will supplement
the traditional randomized controlled trial (RCT).
Publisher
SpringerLinkCitation
Journal of Public Health 21(2013) nr. 3 s. 307-313Metadata
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