Summary
Objectives:
In many medical domains investigator-initiated clinical trials are used to introduce
new treatments and hence act as implementations of guideline-based therapies. Trial
protocols contain detailed instructions to conduct the therapy and additionally specify
reactions to exceptional situations (for instance an infection or a toxicity). To
increase quality in health care and raise the number of patients treated according
to trial protocols, a consultation system is needed that supports the handling of
the complex trial therapy processes efficiently. Our objective was to design and evaluate
a consultation system that should 1) observe the status of the therapies currently
being applied, 2) offer automatic recognition of exceptional situations and appropriate
decision support and 3) provide an automatic adaptation of affected therapy processes
to handle exceptional situations.
Methods:
We applied a hybrid approach that combines process support for the timely and efficient
execution of the therapy processes as offered by workflow management systems with
a knowledge and rule base and a mechanism for dynamic workflow adaptation to change
running therapy processes if induced by changed patient condition.
Results and Conclusions:
This approach has been implemented in the AdaptFlow prototype. We performed several
evaluation studies on the practicability of the approach and the usefulness of the
system. These studies show that the AdaptFlow prototype offers adequate support for
the execution of real-world investigator-initiated trial protocols and is able to
handle a large number of exceptions.
Keywords
Clinical trials - clinical protocols - guidelines - event-oriented exception handling
- adaptive workflow management
