title: Cluster-randomized trial to improve the quality of diabetes management: The study for the efficacy assessment of the standard diabetes manual (SEAS-DM).
abstract: OBJECTIVE
  'The Standard Diabetes Manual' has been developed by clinical researchers from multiple major institutions in Japan, such as the National Center for Global Health and Medicine, as a comprehensive disease management program, including collaboration between primary care physicians (PCPs) and specialist services. The present study evaluated the efficacy of the manual as a quality improvement strategy in diabetes care by PCPs.
  
  
  METHODS
  A total of 42 PCPs in eight domestic districts of the Japan Medical Association were allocated to either the intervention group or the control group in a cluster-randomized design. The PCPs in both groups were provided with a copy of the Diabetes Treatment Guide published by the Japan Diabetes Society, and the PCPs in the intervention group additionally received a copy of the manual and a 30-min relevant seminar at the inception of the intervention. The primary end-point was the adherence to the following performances as quality indicators: evaluation of retinopathy, and urinary albumin excretion measurements and serum creatinine measurements, as recommended by the Japan Medical Association.
  
  
  RESULTS
  A total of 416 patients were enrolled by 36 PCPs. During the 1-year follow-up period, the proportion of PCPs who adhered to recommendation-concordant measurements of urinary albumin excretion was significantly higher in the intervention group than in the control group (adherence: 17.9% vs 5.3%, P = 0.016). The other parameters were not statistically different between the two groups.
  
  
  CONCLUSIONS
  Implementation of 'The Standard Diabetes Manual' potentially leads to an improved quality of diabetes management by PCPs.
authors.affiliation: Endocrinology Department, St. Luke's International Hospital, Tokyo, Japan.|Department of Diabetes Research, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Noto
authors.affiliation: Department of Bio-Signal Analysis, Division of Endocrinology, Metabolism, Hematological Sciences and Therapeutics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Tanizawa
authors.affiliation: Diabetes Center, Aizawa Hospital, Matsumoto, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Aizawa
authors.affiliation: Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.
authors.forename: Hirohito
authors.initials: H
authors.lastname: Sone
authors.affiliation: Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Center, NTT East Corporation, Sapporo, Japan.
authors.forename: Narihito
authors.initials: N
authors.lastname: Yoshioka
authors.affiliation: Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Nobuya
authors.initials: N
authors.lastname: Inagaki
authors.affiliation: Department of Diabetes Research, National Center for Global Health and Medicine, Tokyo, Japan.|Department of Endocrinology and Diabetes, Saitama Medical University, Iruma, Japan.
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Noda
mesh_terms: D000368:Aged; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058007:Physicians, Primary Care; D015397:Program Evaluation; D011785:Quality Assurance, Health Care; D016896:Treatment Outcome
keywords: Disease management; Quality indicator; Randomized trial