A COS is a minimum set of outcomes of specific importance that should be measured and reported in all clinical trials for a specific condition. COS are developed with the input of relevant stakeholders and patient engagement is a central part in the process of COS development.
Clinical trials evaluate the safety and effect of interventions, treatments or care procedures. To enable this, one intervention is compared against a comparative intervention, for example placebo, in a trial. The effect of the intervention is seen as the difference between the groups when measuring different outcomes. It is crucial that these outcomes have a therapeutic importance to relevant stakeholders, such as patients and clinicians.
To enable the best clinical evidence, all clinical trials within a field are often systematically collected, assessed and synthesized in systematic reviews. Often these reviews are unable to synthesize results of individual studies because different outcomes were measured. This, in turn, lowers the certainty of the evidence for the specific intervention.
SBU is, as a producer of systematic reviews, one stakeholder of clinical trials. As such, SBU has been involved as a participant in the development of COS. SBU endorses the usage of robustly developed COS in clinical trials and in systematic reviews.
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