title: Toward a continuous quality improvement paradigm for hemodialysis providers with preliminary suggestions for clinical practice monitoring and measurement.
abstract: BACKGROUND
  Consensus processes using the clinical literature as the primary source for information generally drive projects to draft clinical practice guidelines (CPGs). Most such literature citations describe special projects that are not part of an organized quality management initiative, and the publication/review/consensus process tends to be long. This project describes an initiative to develop and explore a flexible and dedicated data-driven paradigm for deciding new CPGs that could be rapidly responsive to changing medical knowledge and practice.
  
  
  METHODS
  Candidate Clinical Practice Monitoring Measures (CPMM) were selected using a large, national database according to the natures and strengths of their associations with mortality risk among patients during 1994. Thresholds above or below which risk of death increased were evaluated for each CPMM using risk profile charts and spline functions. The fractions of patients outside of those thresholds in each dialysis unit (the %Var) were determined for the years 1993, 1994, and 1995. A standardized mortality ratio (SMR) was also determined for each year for each facility. The associations between the %Var and SMR were evaluated in several single-variable and multivariable statistical models.
  
  
  RESULTS
  Eleven CPMM were selected and evaluated based on their associations with death risk. These included the urea clearance x dialysis time product (Kt); the concentrations of albumin, potassium, phosphate, bicarbonate, hemoglobin, neutrophils, and lymphocytes in the blood; the body weight/height ratio; diastolic blood pressure; and vascular access type. Even though the CPMM were strongly associated with death risk among patients, the %Var were weakly and inconsistently associated with SMR among facilities.
  
  
  CONCLUSIONS
  The paradigm was flexible, easy to implement, quickly executed, and potentially able to accommodate evolving medical practice assuming the availability of large database systems such as this. The primary associates of death risk were easily identified and the thresholds easily adopted. The SMR and %Var from the CPMM were only weakly associated, however, suggesting that one cannot be reliably predicted from the other. As such, quality management programs should likely monitor both the processes and outcomes of care among dialysis facilities.
authors.affiliation: Fresenius Medical Care (NA), Incorporated, Lexington, Massachusetts, USA. edmund.lowrie@fmc-na.com
authors.forename: Edmund G
authors.initials: EG
authors.lastname: Lowrie
authors.forename: Ming
authors.initials: M
authors.lastname: Teng
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Lew
authors.forename: Eduardo J
authors.initials: EJ
authors.lastname: Lacson
authors.forename: J M
authors.initials: JM
authors.lastname: Lazarus
authors.forename: William F
authors.initials: WF
authors.lastname: Owen