title: Collecting direct non-health care and time cost data: application to screening and diagnosis of cervical cancer.
abstract: BACKGROUND
  Data on direct non-health care and time costs are rarely collected, though the incorporation of such data is essential for performing cost-effectiveness analyses according to established guidelines.
  
  
  OBJECTIVE
  To explore the challenges involved in collecting and analyzing these data from patients enrolled in a clinical trial.
  
  
  METHODS
  Through the use of a pilot study, the authors designed a questionnaire to collect these costs. They used this questionnaire in a clinical trial conducted at a comprehensive cancer center and a public community hospital. Patients in the trial were undergoing screening or diagnostic procedures through a clinical protocol designed to measure the effectiveness of fluorescence and reflectance spectroscopy for detecting cervical precancers. Direct non-health care costs were adjusted to 2003 constant dollars.
  
  
  RESULTS
  The authors successfully collected direct non-health care and time cost data, thus demonstrating the feasibility of acquiring such data. Compared to patients receiving diagnostic services for cervical cancer, those receiving screening services for the same condition in both settings incurred lower direct non-health care costs and time costs, as defined in the questionnaire. Compared to patients receiving either service at the comprehensive cancer center, those seeking either service at the public community hospital incurred lower direct non-health care costs and time costs. When outliers were removed, total direct non-health care costs and time costs substantially decreased for diagnostic patients in the comprehensive cancer center; total direct non-health care costs and time costs for other subgroups remained essentially unchanged.
  
  
  CONCLUSIONS
  Direct non-health care and time cost data can be collected within a large-scale clinical trial. The setting (community v. specialty hospital) and population (patients receiving screening v. diagnostic examination) makes a difference regarding the cost totals. The order of magnitude of the final result depends on the context in which the non-health care and time cost data will be used.
authors.affiliation: Department of Biostatistics and Applied Mathematics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030-4009, USA. sbcantor@mdanderson.org
authors.forename: Scott B
authors.initials: SB
authors.lastname: Cantor
authors.forename: Lawrence B
authors.initials: LB
authors.lastname: Levy
authors.forename: Marylou
authors.initials: M
authors.lastname: Cárdenas-Turanzas
authors.forename: Karen
authors.initials: K
authors.lastname: Basen-Engquist
authors.forename: Tao
authors.initials: T
authors.lastname: Le
authors.forename: J Robert
authors.initials: JR
authors.lastname: Beck
authors.forename: Michele
authors.initials: M
authors.lastname: Follen
mesh_terms: D000328:Adult; D003625:Data Collection; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000191:economics / Q000706:statistics & numerical data*; D008875:Middle Aged; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000517:prevention & control*