Problems in development and use of guidelines for clinical practice]

According to the Agency for Healthcare Research and Quality in the USA, the characteristics to be fulfilled by clinical guidelines are validity, reproducibility, reliability, clinical flexibility, clarity and scheduled review. However, most clinical guidelines do not necessarily fully satisfy these factors. I have been engaged in the development of evidence-based guidelines for the management of stroke in Japan. Problems in development of guidelines are as follows. The first is the lack of high level evidence such as randomized controlled trials, which influences recommendation grade. In the case of clinical guidelines for treatment of cerebral hemorrhage in the acute stage, the recommendation grade (C1, C2), which means a lack of sufficient scientific evidence, covered 86% of all recommendation items. The second is ease of clinical application. Evidence based clinical guidelines are not likely to be easy to use if sufficient high-level scientific evidence is not available. It must be realized that guidelines can only be applied to 60 to 95% of patients. Depending on the patient, setting, and other factors, guidelines can and should be tailored to fit individual needs. Deviations from guidelines will be fairly common and can be justified by differences in individual circumstances.