International Journal for Quality in Health Care 15:359-360 (2003)
© 2003 International Society for Quality in Health Care
Letter to the Editor |
Confusion about the concept of clinical practice guidelines in Japan: on the way to a social consensus
Department of Medical Systems Informatics, Kyoto University School of Public Health, Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Kyoto 606-8501, Japan E-mail: nakayama{at}pbh.med.kyoto-u.ac.jp
College of Medical Technology, Kyoto University, Kyoto, Japan
Department of Pharmacoeconomics, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan
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.
In developing clinical practice guidelines and in consideration of the interests of the Japan Medical Association (JMA), a new expression, ‘collection of clinical evidence’, has been coined in the hope of making clinicians more comfortable with the concept [5]. As a result of more recent political compromise, however, the term ‘guideline’ has been revived in governmental projects, but acceptance by clinicians remains problematic.
An additional sign of problems for evidence-based care was suspension of the establishment of a national EBM database at the National Institute of Public Health (NIPH). The Liberal Democratic Party, the leading political party, backed by the JMA, opposed this project in 2000. Although the JMA approved of both EBM and disseminating information to the public, it could not accept the NIPH as the appropriate coordinating body. The JMA felt that governmental development and administration of clinical practice guidelines might compromise professional autonomy and the advancement of medicine. Finally, in 2002, a political compromise placed this project under the Japan Council for Quality Health Care (JCQHC). The JCQHC, established in 1995, is the independent organization authorized to accredit hospitals. Their database will be accessible to both health care professionals and the general public, which is eagerly awaiting access to this information.
Much remains to be done to bring other stakeholders to the table. One of the next concerns that needs to be addressed is that patients, consumers, and legal professionals may overestimate the authority of clinical practice guidelines. All of Japanese society can, and needs to, participate in the process of developing a consensus on clinical practice guidelines. However, an important initial step is to clarify just what clinical practice guidelines are, or are not.
References
- Committee for Examination of Health Technology Assessment. Report About Need and Future Direction of Health Technology Assessment (in Japanese). Health Policy Bureau, Ministry of Health and Welfare, Japan. Available online: http://www1.mhlw.go.jp/houdou/0906/h0627–6.html (1 April 2003, date last accessed).
- Committee for Promoting Health Technology Assessment. Report About Promotion of Health Technology Assessment (in Japanese). Health Policy Bureau, Ministry of Health and Welfare, Japan. Available online: http://www1.mhlw.go.jp/houdou/1103/h0323–1_10.html (1 April 2003, date last accessed).
- Field MJ, Lohr KN (eds). Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academy Press, 1990.
- Last JM, Abramson JH (eds). A Dictionary of Epidemiology. 4th edn. New York: Oxford University Press, 2000.
- Tsutani K. Policy and Politics of Evidence-Based Medicine in Japan (in Japanese). Proceedings of an International Symposium on ‘Evidence and Policy Development’. National Institute of Public Health (Tokyo), Tokyo, Japan.
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