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Design and methods of a strategic outcome study for chronic kidney disease: Frontier of Renal Outcome Modifications in Japan

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Abstract

Background

The continuous increase in the number of people requiring dialysis is a major clinical and socioeconomical issue in Japan and other countries. This study was designed to encourage chronic kidney disease (CKD) patients to consult a physician, enhance cooperation between nephrologists and general practices, and prevent the progression of kidney disease.

Methods

Subjects comprise CKD patients aged between 40 and 74 years consulting a general physician, and patients in CKD stage 3 with proteinuria and diabetes or hypertension. This trial is a stratified open cluster-randomized study with two intervention groups: group A (weak intervention) and group B (strong intervention). We have recruited 49 local medical associations (clusters) in 15 different prefectures, which were classified into four regions (strata) based on the level of increase rate of dialysis patients. The patients in group A clusters were instructed initially to undergo treatment in accordance with the current CKD treatment guide, whereas patients in group B clusters were not only instructed in the same fashion but also received support from an information technology (IT)-based system designed to help achieve the goals of CKD treatment, consultation support centers, and consultations by dietitians visiting the local general practice offices. We assessed the rates of continued consultation, collaboration between general practitioners and nephrologists, and progression of CKD (as expressed by CKD stage).

Conclusion

Through this study, filling the evidence-practice gap by facilitating effective communication and supporting general physicians and nephrologists, we will establish a CKD care system and decrease the number of advanced-stage CKD patients.

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Acknowledgments

We express our thanks to the doctors and dietitians who participated in this study. We also express our thanks for the continuous support from members of the Japanese Society of Nephrology, the Japan Dietetic Association, and the Japanese Medical Association. We further thank Dr. Toshiyuki Imasawa, Dr. Chie Saitoh, Dr. Hirayasu Kai, Dr. Hideto Takahashi, Dr. Masafumi Okada, and Ms. Mariko Doi for valuable discussion and preparation of this manuscript. This study was supported by a grant for a strategic outcome study project from the Ministry of Health, Labor, and Welfare of Japan.

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Authors and Affiliations

  1. Department of Nephrology, Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1, Ten-oudai, Tsukuba, Ibaraki, 305-8575, Japan

    Kunihiro Yamagata

  2. Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan

    Hirofumi Makino

  3. Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan

    Tadao Akizawa

  4. Dialysis Unit, University Hospital of The Ryukyus, Okinawa, Japan

    Kunitoshi Iseki

  5. Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan

    Sadayoshi Itoh

  6. Department of Nephrology and Hypertension, St. Marianna University School of Medicine, Kanagawa, Japan

    Kenjiro Kimura

  7. Division of Endocrinology and Metabolism, Kanazawa Medical University, Ishikawa, Japan

    Daisuke Koya

  8. Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Science, Niigata, Japan

    Ichiei Narita

  9. Division of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical School, Saitama, Japan

    Tetsuya Mitarai

  10. Department of Internal Medicine, Miyazaki Clinic, Miyazaki, Japan

    Masanobu Miyazaki

  11. Department of Nephrology, Osaka General Medical Center, Osaka, Japan

    Yoshiharu Tsubakihara

  12. Department of Internal Medicine III, Fukushima Medical University School of Medicine, Fukushima, Japan

    Tsuyoshi Watanabe

  13. Department of Laboratory Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of Medicine, Kanazawa University, Ishikawa, Japan

    Takashi Wada

  14. Japan Kidney Foundation, Tokyo, Japan

    Osamu Sakai

Authors
  1. Kunihiro Yamagata
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  2. Hirofumi Makino
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  14. Osamu Sakai
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Correspondence to Kunihiro Yamagata.

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Yamagata, K., Makino, H., Akizawa, T. et al. Design and methods of a strategic outcome study for chronic kidney disease: Frontier of Renal Outcome Modifications in Japan. Clin Exp Nephrol 14, 144–151 (2010). https://doi.org/10.1007/s10157-009-0249-4

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  • DOI: https://doi.org/10.1007/s10157-009-0249-4

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