Evidence-based approach to the development of clinical practice guidelines has attracted significant attention from medical groups as well as from the public. According to the U.S. Institute of Medicine, clinical practice guidelines are defined as the systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. However, the role and importance of clinical practice guidelines are not fully understood by stakeholders in Japan. This review aims to introduce real movements related with clinical practice guidelines in Japan, problems and future prospects of them.

EBM is the integration of best research evidence with clinical expertise and patient values. EBM has been extending to “evidence-based healthcare/practice” with wider perspectives. When considering healthcare-related evidence, it is useful to distinguish three aspects. Namely, they are “create”, “communicate”and “utilize”. At first, “clinical questions” are generated in real clinical settings. To create clinical evidence, “clinical questions” need to be refined as “research questions”. Concerning the aspect of communication, there are lots of proposals and statements to improve the reporting of research findings. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals proposed by the International Committee of Medical Journal Editors has been evolved since 1979 and has become the global standard for scientific authors and editors. Concerning the aspect of “utilize”, there are two problems, that is, overuse and underuse of evidence. The former is related with the problem of evidence-practice gap. Appropriate use of clinical practice guidelines are expected to reduce these gaps. The latter is linked with the confusion that evidence equals EBM. Evidence is merely evidence even if the level is high in scientific and general meaning. When clinicians make individual decisions, they are required to do them comprehensively balancing the three factors such as evidence, value and resource.

From the standpoint of a physician, drug safety data include not only information on adverse effects, but also information required to perform drug therapy safely. Drug safety data required by physicians include pharmacological data, name of the drug, history and physical data of patients, and an electronic or paper-based prescribing system at the clinic. Although most physicians are generally interested in drug safety data, a focus is not placed on adverse effects, given that they represent only a minor fraction of what is required for clinical practice and prescribing drugs. Moreover, Japanese physicians, who are busy with daily clinical practice, cannot find the time to extract essential information from what is supplied or to manage, make use, and report adverse events.
Many problems exist in the management of drug safety data, especially for adverse effects, including collection of data, database management, and feedback to physicians. In particular, current adverse effect reporting systems rely too heavily on physicians. In order to improve the sensitivity and management of drug safety data in Japan, it is expected that not only physicians but also pharmacists, paramedical staff, and patients will report drug safety data. One promising possibility is the establishment of a special division at all medical facilities that manages drug safety data. This concept is similar to that of the Governmental Consumer Agency (Shohisha-cho) launched in 2009. As an issue, drug safety traverses all of healthcare, so it may be necessary for the drug safety division to adopt not only specialists whose subspecialties are more focused, but also general physicians.

BACKGROUND: Although structured abstracts are becoming common in English-language journals, little is known about papers written in languages other than English.
METHODS: To identify the percentages of reports of clinical trials with structured abstracts that are written in languages other than English, we used the PubMed to retrieve clinical trial reports written in seven languages other than English from 1987 to 2001.
RESULTS: A total of 23, 075 reports of clinical trials written in seven languages other than English were identified. Of the 18, 278 reports that included abstracts, the share of structured abstracts in each language was as follows (entire period and 1999-2001 in parenthesis) : German, 17.3% (48.2%) ; French, 16.1% (45.1%) ; Italian, 21.3% (76.3%) ; Spanish, 44.7% (74.9%) ; Russian, 4.9% (17.4%) ; Chinese, 21.3% (100%), and Japanese, 3.5% (10.4%) .
CONCLUSIONS: This study revealed that structured abstracts written in languages other than English have become popular, particularly since the late 1990s. However, the percentages of reports that include structured abstracts differ greatly among these languages.

In Japan, a government-funded project to develop evidence-based guidelines for the treatment of rheumatoid arthritis started in 1999. Methodologists, including epidemiologists and medical librarians, were asked to participate in this project. Working as a team, the rheumatologists, clinical epidemiologists, and medical librarians reviewed the published evidence systematically. The process and the results, particularly systematic search and review of literature, were assessed from the viewpoint of epidemiology and evidence-based medicine (EBM) . The librarians, supervised by the clinical epidemiologists, searched the literature according to 30 key questions defined by the rheumatologists and classified the articles according to the“level of evidence”. Finally, 379 articles were selected (drug therapy, 207; surgical treatment, 108; rehabilitation/devices, 64) . Meta-analyses and randomized controlled trials accounted for more than 80% of the drug treatment and rehabilitation/device reports, while nearly 70% of the articles retrieved regarding surgical treatment were case series without relevant control groups. The rheumatologists wrote structured abstracts for each article so that they could be used as reference for developing practice guidelines. The literature search, individual original articles, and the PubMed system were examined from the viewpoint of research methodology; the lessons learned were described.
In conclusions, clinical epidemiologists and medical librarians have contributed to developing evidence-based practice guidelines. Clinical epidemiologists were able to work as a coordinator between clinicians and medical librarians. The popularity of EBM requires that expertise in this field be strengthened and made available to a broader audience.

In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.

To investigate the efficacy of human superoxide dismutase (h-SOD) in myocardial ischemia and reperfusion with difference of administration of h-SOD, twenty four dogs were subjected to 120min ischemia by the cross clamping of the ascending aorta, and followed by 60min reperfusion, The dogs were randomly assigned to three groups: group G, h-SOD (8mg/kg) was injected into the cardiopulmonary bypass (CPB) circuit 5min prior to reperfusion; group L, h-SOD (3mg/kg) was administered by bolus injection through the aortic root into the coronary artery 1min prior to reperfusion; group C, nothing was administered. The values of creatinine phosphate MB isozyme (CPK-MB) and a-hydroxydehydrogenase (HBD) in coronary effluent, and lipid peroxides (LPO) in coronary artery and sinus blood, were measured during CPB. Cardiac function was evaluated by cardiac index (C. I.) and LV max d_p/d_t, and it was expressed as a percent recovery of pre-CPB state. Myocardial water contents as myocardial edema were measured after CPB. Effluents of CPK-MB and HBD at 60min after reperfusion were less in group L than group G, C. Generations of LPO (A-Cs difference) were less at 5min after reperfusion in group G, L than group C and there were significant differences between group G, L and group C. The percent recovery of C. I. and LV max d_p/d_t at 60min after reperfusion was superior in group G, L than group C and there were significant difference between group G, L and group C. Myocardial water contents at 60min after reperfusion were less in group G, L than group C and there were significant difference between group G, L and group C. In the lipid peroxides generation, cardiac function and myocardial edema except effluents of cardiac enzymes, group G was as well as group L. These data suggest that the injection of h-SOD into the CPB circuit just before reperfusion is effective to prevent the reperfusion injury as well as the administration through the aortic root.