Efficacy versus effectiveness: What’s the use of registries?

RCTs alone are not enough – this short sentence summarizes the benefit medical registries offer. The necessity of randomized controlled trials (RCTs) is of course not at all put into question. However, due to their selective in- and exclusion criteria, their specific setting and their limitation to a concrete research question in a strictly defined study group, RCTs do not reflect clinical routine adequately. Results generated from RCTs and other clinical studies are purely statistical and normally do not allow individual statements. As a result, their transferability into clinical practice is often difficult. At this point, registries come into play. Since a representative sample of the target population (sometimes even the whole target population) is included, registries show what actually happens in daily healthcare so that therapeutic flaws can be revealed and procedures can be optimized. In this way, indications for a therapy can be defined more precisely; differences in sub-groups can be assessed, long-term and side effects of a therapy can be recorded and safety profiles can be analyzed. In addition, registry data offer the possibility of economic evaluations of a therapy. All these aspects show that medical registries are an important source of information for quality assurance and for optimized treatment and that they are indispensable for transferring scientific results into clinical routine.

„Science tells us what we can do;
Guidelines what we should do;
Registries what we are actually doing. „
Lukas Kappenberger MD
Heart Rhythm Society Policy Conference
Washington DC 2005

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