title: Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials.
abstract: BACKGROUND
  Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories.
  
  
  METHODS
  In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance.
  
  
  RESULTS
  Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%.With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients.
  
  
  CONCLUSIONS
  Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has to be modified because of the increased standard deviation. This approach is suitable to enable economic evaluation with lower costs to both study participants and investigators.
  
  
  BACKGROUND
  The trial registration number is ISRCTN02893746.
authors.affiliation: Helmholtz Zentrum München-German Research Center for Environmental Health, Institute of Health Economics and Health Care Management, Munich, Germany. hildegard.seidl@helmholtz-muenchen.de
authors.forename: Hildegard
authors.initials: H
authors.lastname: Seidl
authors.forename: Christa
authors.initials: C
authors.lastname: Meisinger
authors.forename: Rupert
authors.initials: R
authors.lastname: Wende
authors.forename: Rolf
authors.initials: R
authors.lastname: Holle
mesh_terms: D000368:Aged; D019090:Case Management / Q000191:economics / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000379:methods*; D017046:Cost Savings / Q000592:standards / Q000706:statistics & numerical data*; D003362:Cost-Benefit Analysis / Q000379:methods* / Q000706:statistics & numerical data; D003625:Data Collection / Q000379:methods* / Q000592:standards; D036262:Empirical Research; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D031168:Matricaria; D009203:Myocardial Infarction / Q000191:economics / Q000451:nursing; D015203:Reproducibility of Results; D018401:Sample Size