Introduction
The context (the distinctive features of a trial's setting,
participants, clinicians and other staff) in which a trial is done
is clearly important when considering how applicable its results
are to other contexts (see Intervention Design) , or for that
matter, routine care within the same context in which the trial was
done. To support interpretation of a trial's results,
trialists should do all they can to describe the context of their
trial (see Interpretation).
Despite its importance, there is little guidance about what
should be reported about context and little work exploring how
context might influence the results of a trial (1), or
the feasibility of widespread implementation. NPT provides a
consistent framework with which to describe context for these
purposes. Because NPT focuses on collective action and
processes, it can help you to discover what people actually,
practically, do. How people do things is (a very important
part of the trial's context. For example, under NPT's
Collective
Action component, which looks at how work gets done, trialists
may find that an important part of their trial's context is a
particular element of the existing training offered to nurses
working in primary care. In jurisdictions where this element
of training is not provided, the intervention may not be successful
without provision of additional training to primary care nurses
prior to using the intervention.
It is important to note that some of this context-mapping could
happen before the trial (as in the example above) but, other
elements may only be possible after the trial has started.
For example, Reflexive Monitoring requires that
individuals have experience of the intervention, which clearly can
only be assessed once the trial has started. They may use
their experience of the intervention during initial pilot work to
critically assess contextual issues and this, in turn, may shape
further pilot work and the design of the intervention for the main
trial.
Things to consider
- Describing context is important if others are to make informed
judgements about the applicability of your trial's results to their
own situation.
- Describing context is difficult; you may not be conscious of
some elements of your own context. NPT will help you to ask
questions about your context and to enhance your description
- Do you already believe that your intervention depends on one or
more aspects of the particular context in which the trial is being
done? Readers of your trial report need to know this; NPT
might help you structure how you describe your trial to
readers.
- If an element of your context is missing (e.g. easy access to a
particular piece of equipment) does your trial become an
aspirational trial, which would require major structural changes to
a healthcare system to implement? Readers of your trial
report need to know this.
- Describing context is important if others are to make informed
judgements about the applicability of your trial's results to their
own situation.
References
- Wells EM: Behind the
scenes of randomised trials of complex interventions - insiders
reveal the importance of context. PhD Thesis. University of Dundee;
School of Nursing and Midwifery; 2007. Back to text
