Under the prevailing ”disease-oriented” paradigm of health, Quality of Life (QOL) has been treated with profound skepticism. Two facts, however, militate for taking QOL seriously into account : first, both social and clinical decision making today require evidence presented in the form of patient outcomes; second, of patient outcomes, one of the most important from the patient's standpoint is QOL. Giving several examples, the author discusses why traditional endpoints are insufficient and why patient-based outcomes are relevant in modern social and clinical decision making.
And yet not all outcomes are relevant : for the purposes of assessment of health and medical care, QOL should be confined to its health-related elements, and instruments to measure health-related quality of life (HRQOL) should be rigorously tested with psychometric methods. Even more important, however, is the instrument's content validity : i. e., whether it measures what one wants to measure. This paper lists criteria for selection of appropriate instruments and describes the recent debate and moves to formulate guidelines on the use of HRQOL evidence in pharmaceutical product approvals and manufacturers' product efficacy claims. Finally, the author discusses the future of HRQOL research and uses of HRQOL in clinical practice.

1) Japanese clinical research and population-based medicine have different origins and have lived separate lives. After 100 years of mutual isolation, their paths are about to cross.
2) Clinical research is not confined to clinical trials and translational research, but covers a wider area that includes outcomes research, economic evaluation, and studies of the quality of care.
3) Government policymakers very recently turned their attention to clinical research, and set up administrative schemes to provide large-scale funding.
4) However, unlike the US, Japan cannot catch this wave because it does not have the necessary intellectual infrastructure of trained clinical investigators.
5) Population-based medicine and clinical research have similar emphases and core values. Both are concerned with measuring frequencies, with socially relevant outcomes, and with the impact of research on clinical practice and health policy.

Introduction: There are no studies on how much primary care research from Japan has spread internationally. In this study, we aimed to investigate Japan's contribution to high-impact international primary care journals.

Methods: We used the PubMed database and reviewed abstracts to examine the frequency of articles reporting clinical research or systematic reviews originating from Japan that were published in 5 high-impact international primary care journals from January 2011 to June 2016. We calculated the proportion of articles from Japan in the selected journals by year and journal.

Results: Of the total articles (2,602), the proportion of Japanese articles in 5 high-impact international primary care journals was 0.15% (4 articles).

Conclusion: Currently, Japan's contribution to high-impact international primary care journals is very small. In Japan, the development of research infrastructure, the education of researchers, and networks for research collaboration may be needed for international dissemination of primary care research.

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.

1) I participated in the postgraduate clinical research training program at the University of California, San Francisco.
2) The program included course work for acquiring knowledge about conducting clinical research and an individual mentoring system that provided effective support for researchers to conduct their own research.
3) To improve mentoring skills, trial programs were implemented, including specific education programs for faculty and performance evaluations.

OBJECTIVE: Advance directives that assume respect for individual autonomy in end-of-life decisions may not be accepted in all cultures. We studied Japanese preferences concerning care planning and written advance directives.
DESIGN: A nationally representative Japanese sample answered questions about their preferred mechanism of care planning and preferences for end-of-life care. Factors associated with wishing to participate in care planning were evaluated by logistic regression.
RESULTS: Seventy-eight percent of the respondents wanted to be directly involved in care planning. The preferred option for that planning was discussion within the family. The family also emerged as a potential source of knowledge of the patient's values that could inform a physician's decision. Only 23% of respondents desired any type of written advance directive. Greater desire for care planning was related to greater autonomy preference, greater information seeking, greater desire for personal and family decision making, and less willingness to tolerate adverse health states. Women, married subjects, better-educated subjects, and those living alone were more likely to want to participate in care planning.
CONCLUSIONS: Most Japanese people want to participate in care planning, but the types of written advance directives most commonly used in the U.S. are not suitable. Japanese physicians should provide adequate information about prognosis and should encourage early conversations about preferences for life-sustaining interventions between patients and their family members.

Objective: The present study examined the status of the provision of drug information to hypertensive patients at community-based pharmacies by evaluating patients' satisfaction, understanding, and wishes.
Design: A cross-sectional study was conducted by surveying patients using a self-administered questionnaire.
Methods: Three items were evaluated: 1) the level of patient satisfaction with provision of drug information; 2) the level of patient understanding of information provided on antihypertensive drugs; and, 3) patient wishes regarding provision of drug information.
Results: The level of satisfaction with provision of drug information was high (86.6%). Although patients were found to understand the precautions for use of antihypertensive drugs, their understanding of drug efficacy was insufficient. Also, patients wished to receive more explanation from pharmacists regarding the efficacy of drugs in addition to explanations of associated adverse reactions or precautions for use of the drugs.
Conclusions: Hypertensive patients were highly satisfied with the provision of drug information at community-based pharmacies, but did not show sufficient understanding of the efficacy of antihypertensive drugs, an issue to be addressed in the future by pharmacists in their instructions to patients on the use of drugs.

Background: Because of a severe shortage of clinical researchers in Japan, training clinical physicians to perform clinical research is an important issue in medical education. Although education has started to provide a foundation for clinical research, it is unclear whether clinicians, who should play a central role in a clinical research, are interested in performing clinical research and participating in a training program for clinical research.1) We performed a cross-sectional Internet survey to determine the interest of clinicians' interest in performing a clinical research and participating in a clinical-research training program.2) A total of 2176 clinicians were sent emails requesting their participation in this survey, and 310 responded (response rate, 14.6%). Eighty-five percent of the respondents were interested in conducting clinical research, and 78% were willing to participate in a clinical-research training program.3) Most respondents were willing to participate in a training program as part of an educational seminar or a training course after a few years of clinical practice. The respondents desired an educational system that would allow them to learn about clinical research while continuing their clinical practice.4) Although the rate of willingness to participate in a training program was highest (90%) among respondents who wanted to earn a doctorate, the rates were also high among those who did not want to earn a doctorate (76%) and those who had already earned a doctorate (74%).5) An educational system for clinical research should allow graduate schools to play leading role in training and should be flexible enough for clinicians who do not want to earn a doctorate.

We conducted a national survey to examine the status of programs to teach evidence-based medicine (EBM) to undergraduates in Japan. Our survey specifically focused on four areas: 1) recognition of a need to teach EBM, 2) the present status of programs to teach EBM to undergraduates, 3) details of the timing of existing EBM teaching programs and of departments responsible for it. Sixty-four schools (80%) responded. Nearly all respondents agreed that EBM should be taught, and most agreed that it should be taught both before and after graduation. Most respondents stated that departments must collaborate when preparing to teach EBM. At the time of the survey, 22 medical schools (34%) had already started programs to teach EBM and 28 (42%) were planning to do so. Existing programs mainly targeted 4th-year students, but the department responsible for the programs varied among schools. Further evaluation of the effectiveness of existing programs is now needed.

We conducted a nationwide survey in 2000 regarding undergraduate medical education in Evidence-based Medicine (EBM) in Japan. We asked faculty members responsible for medical education at each medical school 1) whether there are any barriers to teaching EBM, 2) what these barriers are, and 3) what educational resources are needed to overcome them. Responses were received from 64 schools (80%). More than half of the respondents reported barriers to teaching EBM. We identified two kinds of barriers: before EBM is introduced, skepticism toward the concept of EBM and the value of teaching EBM is encountered; later, problems of organizing a curriculum and shortages of staff and materials are encountered. To overcome these barriers, we need: 1) to establish organizations for coordinating educational programs among medical schools, 2) to hold seminars for faculty development, 3) to develop EBM curricula and teaching materials, and 4) to provide computer facilities and appropriate networks.