title: Validity of diagnoses, procedures, and laboratory data in Japanese administrative data.
abstract: BACKGROUND
  Validation of recorded data is a prerequisite for studies that utilize administrative databases. The present study evaluated the validity of diagnoses and procedure records in the Japanese Diagnosis Procedure Combination (DPC) data, along with laboratory test results in the newly-introduced Standardized Structured Medical Record Information Exchange (SS-MIX) data.
  
  
  METHODS
  Between November 2015 and February 2016, we conducted chart reviews of 315 patients hospitalized between April 2014 and March 2015 in four middle-sized acute-care hospitals in Shizuoka, Kochi, Fukuoka, and Saga Prefectures and used them as reference standards. The sensitivity and specificity of DPC data in identifying 16 diseases and 10 common procedures were identified. The accuracy of SS-MIX data for 13 laboratory test results was also examined.
  
  
  RESULTS
  The specificity of diagnoses in the DPC data exceeded 96%, while the sensitivity was below 50% for seven diseases and variable across diseases. When limited to primary diagnoses, the sensitivity and specificity were 78.9% and 93.2%, respectively. The sensitivity of procedure records exceeded 90% for six procedures, and the specificity exceeded 90% for nine procedures. Agreement between the SS-MIX data and the chart reviews was above 95% for all 13 items.
  
  
  CONCLUSIONS
  The validity of diagnoses and procedure records in the DPC data and laboratory results in the SS-MIX data was high in general, supporting their use in future studies.
authors.affiliation: Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan; Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan. Electronic address: yamana-tky@umin.ac.jp.
authors.forename: Hayato
authors.initials: H
authors.lastname: Yamana
authors.affiliation: Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan; Quality Management Center, Medical Hospital, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Mutsuko
authors.initials: M
authors.lastname: Moriwaki
authors.affiliation: Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Horiguchi
authors.affiliation: Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan; Department of Health Policy and Informatics, Tokyo Medical and Dental University, Graduate School of Medicine, Tokyo, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Kodan
authors.affiliation: Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan; Quality Management Center, Medical Hospital, Tokyo Medical and Dental University, Tokyo, Japan; Department of Health Policy and Informatics, Tokyo Medical and Dental University, Graduate School of Medicine, Tokyo, Japan.
authors.forename: Kiyohide
authors.initials: K
authors.lastname: Fushimi
authors.affiliation: Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Yasunaga
mesh_terms: D019411:Clinical Laboratory Techniques; D016208:Databases, Factual / Q000592:standards*; D006801:Humans; D007564:Japan; D008499:Medical Records; D015203:Reproducibility of Results
keywords: Administrative data; Diagnosis; Laboratory data; Procedure; Validation