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


CONCLUSIONS
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.
Yamagata
Kunihiro
K
Department of Nephrology, Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan. k-yamaga@md.tsukuba.ac.jp
Makino
Hirofumi
H
Akizawa
Tadao
T
Iseki
Kunitoshi
K
Itoh
Sadayoshi
S
Kimura
Kenjiro
K
Koya
Daisuke
D
Narita
Ichiei
I
Mitarai
Tetsuya
T
Miyazaki
Masanobu
M
Tsubakihara
Yoshiharu
Y
Watanabe
Tsuyoshi
T
Wada
Takashi
T
Sakai
Osamu
O
D018450:Disease Progression; D005260:Female; D006801:Humans; D007564:Japan; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008019:Life Style; D008297:Male; D017063:Outcome Assessment, Health Care; D010348:Patient Care Team; D010353:Patient Education as Topic; D012017:Referral and Consultation; D006435:Renal Dialysis / Q000191:economics; D051436:Renal Insufficiency, Chronic / Q000628:therapy*; D016896:Treatment Outcome