[The role of randomised controlled trials in the medical evaluation of routine procedures].
If a demand exists for the evaluation of the favourable and adverse effects of a medical procedure, a comparison is required; this comparison should be fair. The only procedure that ensures a fair comparison is randomisation. Randomised controlled trials (RCTs) therefore represent the gold standard in the evaluation of medical procedures; the non-application of a randomisation process must be justified in detail in individual cases. Reasons presented for not conducting an RCT are mainly based on a misunderstanding of the term "randomisation". They may also be based on circumstances where the conduct of any simultaneous comparison is unsuitable (independent of the mode of allocation) or on situations where there is practically no hypothesis available for a comparison, or even for a study. These factors are taken into account by the current regulations valid in Germany on the approval of drugs and on the reimbursement eligibility of health care services by statutory health insurance.
Lange
S
S
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Köln. stefan.lange@iqwig.de
D020811:Biomedical Technology / Q000379:methods* / Q000458:organization & administration; D003659:Decision Making, Organizational; D019317:Evidence-Based Medicine / Q000379:methods*; D005858:Germany; D010043:Outcome and Process Assessment, Health Care / Q000379:methods* / Q000458:organization & administration; D010818:Practice Patterns, Physicians'; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013673:Technology Assessment, Biomedical / Q000379:methods* / Q000458:organization & administration