INTRODUCTION
The Comparative Effectiveness Research initiative and regulatory agencies have challenged the Outcome Measures in Rheumatology (OMERACT) initiative, and similar organizations, to establish truthful, discriminative and feasible patient-important outcomes for randomized controlled trials (RCTs) and non-randomized studies.
As the founders of OMERACT elegantly wrote in 1993, ˝Clinical trials are only as credible as their endpoints˝ (2).
If we are to believe the results of a clinical trial designed to investigate benefits and harms of a treatment, the trial outcomes measures must be ones that are important and relevant to patients, health care practitioners, policy-makers and other decision makers, and have demonstrated acceptable measurement properties.
In addition, the same important outcomes should be measured in all clinical trials of the same conditions and class of interventions to allow for pooling of results across trials, thereby improving the wider evidence base and reducing research waste.
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