Abstract
Introduction: Randomized Controlled Trials (RCT) are the golden standard in nowadays evidence based outcome assessment. Nevertheless, RCTs in surgery are associated with several concerns. The major concern focuses on ethical issues when randomization is done.
Method: We conducted an indebt analysis on advantages and disadvantages of three types of data acquisition (Case Control Study (CCS), RCT, and Registries) where scientific impact, ability to assess changes over time, cost efficiency, time consumption, ability to provide bench marks and other variables are compared.
Results: RCTs are best regarding the scientific impact. Registers are superior in detecting changes over time (post market surveillance, early warning system), cost efficiency, time consumption, ability to provide benchmarks, local/national/international comparability and ability to let private practitioners participate. CCSs are of minor value in respect to all the assessed variables.
Conclusion: In Surgery, registries are an excellent alternative to RCTs if a great majority of the treating physicians (in respect to a therapy) participate and if all the treated patients (per physician) are included. The register increases its scientific impact if alternative therapies are included (control). In this case, the scientific impact of a register is getting nearly equivalent to RCTs.
Take home message: If ethical aspects allow an RCT, than the RCT is the study set up of choice when a new technique/implant has to be introduced in the market. Once the implant has proved its evidence, the following post market surveillance should be accompanied by registries (introduction of an implant in each country). If an RCT is not indicated (ethical or other contra indications), than registries should be used to prove evidence for an indicated therapy. CCSs are not recommended.
Correspondence should be addressed to ERASS Office, Schulthess Klinik, Lengghalde 2, CH-8008 ZURICH, Switzerland.
