title: Value of information analysis optimizing future trial design from a pilot study on catheter securement devices.
abstract: BACKGROUND
  Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional information.
  
  
  OBJECTIVE
  To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial.
  
  
  METHODS
  An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared.
  
  
  RESULTS
  Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%.
  
  
  CONCLUSIONS
  Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated.
  
  
  CONCLUSIONS
  The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials.
authors.affiliation: Griffith Health Institute, Griffith University, Gold Coast, QLD, Australia Centre for Applied Health Economics, School of Medicine, Griffith Health Institute, Griffith University, Meadowbrook, QLD, Australia haitham.tuffaha@griffith.edu.au.
authors.forename: Haitham W
authors.initials: HW
authors.lastname: Tuffaha
authors.affiliation: National Health and Medical Research Council (NHMRC) Centre for Research, Excellence in Nursing Interventions for Hospitalized Patients, Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Nathan, QLD, Australia Department of Anesthesiology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
authors.forename: Heather
authors.initials: H
authors.lastname: Reynolds
authors.affiliation: Griffith Health Institute, Griffith University, Gold Coast, QLD, Australia Centre for Applied Health Economics, School of Medicine, Griffith Health Institute, Griffith University, Meadowbrook, QLD, Australia.
authors.forename: Louisa G
authors.initials: LG
authors.lastname: Gordon
authors.affiliation: National Health and Medical Research Council (NHMRC) Centre for Research, Excellence in Nursing Interventions for Hospitalized Patients, Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Nathan, QLD, Australia Department of Anesthesiology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
authors.forename: Claire M
authors.initials: CM
authors.lastname: Rickard
authors.affiliation: Griffith Health Institute, Griffith University, Gold Coast, QLD, Australia Centre for Applied Health Economics, School of Medicine, Griffith Health Institute, Griffith University, Meadowbrook, QLD, Australia.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Scuffham
mesh_terms: D002406:Catheterization, Peripheral / Q000295:instrumentation*; D057785:Catheters; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D006801:Humans; D009010:Monte Carlo Method; D010865:Pilot Projects; D011793:Queensland; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013223:Statistics as Topic
keywords: Value of information; cost-effectiveness; peripheral catheters; trial design