Conceptional and structural conditions for successful clinical research.
The efficiency of surgical research has again become the subject of debate. Clinical research is required to improve our understanding of surgical disorders and our ability to treat patients. This involves both experimental research (research in the test tube) and clinical research in actual patients. The surgeon must remain the expert because it is he who deals with the patient and is confronted with his problems. On the other hand, care for the patient, must always be the central issue. Here a new orientation is needed, evaluating the effectiveness of surgical research from the patient's point of view. Surgical treatment, particularly surgical research, must be adapted first to the individual patient and only secondly to the surgical disease - the problem must determine the method, not vice versa. While it is clear that a creative atmosphere, supportive structure and efficient organisation are enormously helpful, today's exaggerated attention to matters of structure and organisation are often poor substitutes for creativity and intuition. Surgical research does not refer solely to therapy research but includes methods for carrying out controlled clinical trials, establishing guidelines and scores and designing instruments for measuring outcome. Socioeconomic and analyses and ethical considerations are crucial for facing such conflicts as "quality versus quantity", "profession versus business", "patient care versus economics costs". Proposals for designing more effective concepts, structure and organisation for clinical research are presented here, and three models are introduced: the cooperation model, the integration model and a mixture of the two.
Troidl
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Universität zu Köln, II. Lehrstuhl für Chirurgie, Chirurgische Klinik Köln-Merheim, Cologne, Germany.
D005500:Follow-Up Studies; D013502:General Surgery / Q000379:methods* / Q000592:standards; D006801:Humans; D008962:Models, Theoretical; D011788:Quality of Life; D012106:Research / Q000458:organization & administration*; D012107:Research Design; D012680:Sensitivity and Specificity; D013514:Surgical Procedures, Operative / Q000592:standards*; D016896:Treatment Outcome