title: Construct validity of medicare chemotherapy claims: the case of 5FU.
abstract: BACKGROUND
  The elderly are under represented in clinical trials of cancer therapy and the elderly who are enrolled may be unrepresentative.
  
  
  OBJECTIVE
  To assess whether Medicare claims data might be used to understand the benefits and tolerance of chemotherapy in the general elderly population, the construct validity of Medicare 5FU claims for elderly colon cancer patients within the SEER-Medicare data set was determined.
  
  
  METHODS
  In this validation study of Medicare chemotherapy claims from the linked the SEER-Medicare data set, the patterns of 5FU chemotherapy claims were evaluated for an incident cohort of elderly colon cancer patients (n = 15,039) during the 13 months following their diagnosis. Patterns of Medicare National Claims History (NCH) 5FU claims were evaluated with respect to prespecified patient-level disease and demographic factors from the data set.
  
  
  RESULTS
  Twenty-two percent of patients had at least one detectable 5FU claim during the observation period. Among those patients, the median dose of 5FU was 1000 mg, the median interval between 5FU claims was 7 days, and the median number of claims during this period was 24. Multivariate regression revealed expected associations between demographic and disease factors and the likelihood of having a Medicare NCH 5FU claim. With increasing cancer stage, patients' likelihood of having a 5FU claim increased. Younger patients, married patients, white patients, patients with low comorbidity, and patients living in urban and less impoverished regions were each more likely to have 5FU claims.
  
  
  CONCLUSIONS
  Because their pattern is consistent with the standard of medical care and with previously described associations with disease and demographic factors, it was concluded that Medicare NCH claims for 5FU administration in the SEER-Medicare data set exhibit construct validity. Criterion validation studies with an external gold standard should be pursued to determine the sensitivity and specificity of chemotherapy codes in the Medicare NCH files.
authors.affiliation: Section of Hematology-Oncology, University of Chicago, Illinois 60637, USA.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Lamont
authors.forename: Diane S
authors.initials: DS
authors.lastname: Lauderdale
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Christakis
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D003625:Data Collection / Q000706:statistics & numerical data; D003710:Demography; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007345:Insurance Claim Review / Q000706:statistics & numerical data*; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data*; D018426:SEER Program / Q000706:statistics & numerical data; D014481:United States / Q000453:epidemiology
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil