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Patient relevant outcomes, measured using questionnaires, are becoming increasingly popular endpoints in randomized clinical trials (RCTs).
Ultimately the patient relevant consequences are determined with the strategy chosen at the time of the ACL rupture.
A recent survey by the Drug Information Association cited results as "reduced screen failure rates, faster patient recruitment, improved subject retention, reduced protocol amendments, and a greater number of patient relevant endpoints".
The added benefit is mainly determined using patient relevant outcomes.
The results items comprised three items on baseline characteristics and eight on patient relevant outcomes.
The development of patient relevant outcomes is key to any further research in this area.
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In many recent studies, positive results on patient relevant outcomes could be shown.
One can distinguish between surrogate-parameters and patient-relevant outcomes.
However, the role of patient-relevant outcomes is increasing.
PFS per se is of immediate, clinically and patient-relevant value in these patients [23].
As mentioned, the acknowledgement of a patient-relevant medical benefit by the GBA is crucial.
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