Study patients and routine practice patients

Abstract

Dear Sir, The road to acceptance in routine practice of important results from clinical trials is sometimes very long. It may be shorter in countries where fear of litigation is a reality and where physicians are aware of the necessity to provide evidence-based medicine. However, in my own country I have experienced a reluctance, or perhaps only a lack of interest, in adopting the conclusions from repeated trials demonstrating that the duration of anticoagulation after venous thromboembolism needs to be prolonged [1, 2]. In the majority of patients the duration of secondary prophylaxis should be about 6 months, in some maybe a year, whereas in those with a distal deep vein thrombosis and a temporary cause 6 weeks will suffice. It is not acceptable to state that patients in clinical practice are different from study patients and therefore cannot be given the same treatment. A large number of the patients in routine practice could very well have been study patients if they were diagnosed at the time when a suitable trial was going on and if they had the time to participate. This large group, which does not have contraindications to standard therapy, is entitled to the optimum therapy, as demonstrated in multicentre randomized clinical trials. It may be possible that family practitioners are unable to provide the same quality of anticoagulation as the study centres at major hospitals [3-6]. But should patients suffer for that reason? Would it not be more appropriate in that case to centralize the care to anticoagulation clinics with more than just a few patients on vitamin K antagonists and with improved outcome? If that is not possible, the use of computer assisted dosing has also been beneficial [7, 8]. It is not necessarily true that study patients are monitored more often than those in routine practice. In the DURAC trials it was stipulated that prothrombin times (PTs) ought to be performed at least once a month [1]. In fact many of the patients were only monitored once every 3–4 weeks. On the other hand, ever so often I see patients who are managed by their family physicians with PT-tests every week, when there is no need for it, because the levels are actually quite stable, but the dosing was not always optimal. Thus, I believe that it is time for the physicians in routine practice to adopt the evidence that has been produced and published lately in this field! Received 24 August 2000; accepted 24 August 2000.