Confusion about the concept of clinical practice guidelines in Japan: on the way to a social consensus

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To the Editor: In Japan, the first governmental report on health technology assessment (HTA) officially introduced evidence-based medicine (EBM) in 1997 [1], followed in 1999 by the second report, referring to the need to develop evidence-based clinical practice guidelines [2]. The Ministry of Health and Welfare established priorities for the development of clinical practice guidelines in the latter report, and started several projects to promote EBM. The budget to develop each guideline was ¥60 000 000 (approximately US$500 000 or €460 000) over 2 years. Beginning with essential hypertension, diabetes mellitus, and bronchial asthma, 20 clinical practice guidelines were to be developed by 2003. However, some problems have emerged. Although experts had previously published clinical recommendations, these were recognized as personal opinions and had no restrictive power on clinicians' practice. Under the on-going government-sponsored project, the guidelines have been developed by authoritative academic societies within a government-funded framework, so clinicians may regard them as canonical. In Japan, what ‘guideline’ means and how guidelines work are unclear, because the word ‘guideline’ is ambiguous. The US Institute of Medicine defines clinical practice guidelines as ‘systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances' [3]. Furthermore, the Dictionary of Epidemiology states ‘…directives are stronger than recommendations, which are stronger than guidelines’ (emphasis added) [4]. However, Japanese people do not usually recognize these distinctions, and tend to regard guidelines as mandatory directives even in individual cases.

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