title: Does enrollment in a randomized clinical trial lead to a higher cost of routine care?
abstract: BACKGROUND
  Reimbursement for the routine care of patients enrolled in clinical trials is controversial. Our objective was to determine the added medical costs, if any, associated with enrollment in a randomized clinical trial.
  
  
  METHODS
  We analyzed data from the Myocardial Infarction Triage and Intervention (MITI) Trial (1988-1991) and the registry of all patients admitted to 19 Seattle area coronary care units (1988-1993). The major trial entry criteria were age 35 to 71 years, symptom duration 15 minutes to 6 hours, and acute myocardial infarction on electrocardiogram. The trial group consisted of 264 of 324 randomized patients who received thrombolytics and had available cost data. From 11,932 registry patients, we identified a control group who met trial entry criteria but who were not enrolled because of logistic barriers or presentation outside the trial enrollment period, 335 of whom received thrombolytics and had available cost data. The groups were compared for total cost for initial hospitalization, with and without multivariable adjustment for baseline characteristics.
  
  
  RESULTS
  Total hospital cost was not different between trial patients (median $11,516) and control subjects (median $14,200) (trial/control mean cost ratio 0.91 [95% CI 0.82-1.02]). Participation in the trial had an insignificant effect on costs in the multivariable model (cost ratio 1.04, 95% CI 0.95-1.16). Significant predictors of cost included hospital of admission, length of stay, and coronary revascularization procedures.
  
  
  CONCLUSIONS
  Participation in the MITI randomized trial had no effect on the cost of routine care.
authors.affiliation: Department of Health Research and Policy, Stanford University School of Medicine, Stanford, Calif 94305-5405, USA.
authors.forename: J Peter
authors.initials: JP
authors.lastname: Weiss
authors.forename: Lori S
authors.initials: LS
authors.lastname: Parsons
authors.forename: Nathan R
authors.initials: NR
authors.lastname: Every
authors.forename: W Douglas
authors.initials: WD
authors.lastname: Weaver
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hlatky
mesh_terms: D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D003325:Coronary Care Units / Q000191:economics*; D005260:Female; D005343:Fibrinolytic Agents / Q000191:economics* / Q000627:therapeutic use; D006302:Health Services Research; D017721:Hospital Costs / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D006278:Medicare / Q000191:economics / Q000331:legislation & jurisprudence; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000191:economics*; D016032:Randomized Controlled Trials as Topic / Q000191:economics*; D012042:Registries; D010959:Tissue Plasminogen Activator / Q000191:economics / Q000627:therapeutic use; D014861:Washington
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator