title: Design of telehealth trials--introducing adaptive approaches.
abstract: BACKGROUND
  The field of telehealth and telemedicine is expanding as the need to improve efficiency of health care becomes more pressing. The decision to implement a telehealth system is generally an expensive undertaking that impacts a large number of patients and other stakeholders. It is therefore extremely important that the decision is fully supported by accurate evaluation of telehealth interventions.
  
  
  OBJECTIVE
  Numerous reviews of telehealth have described the evidence base as inconsistent. In response they call for larger, more rigorously controlled trials, and trials which go beyond evaluation of clinical effectiveness alone. The aim of this paper is to discuss various ways in which evaluation of telehealth could be improved by the use of adaptive trial designs.
  
  
  RESULTS
  We discuss various adaptive design options, such as sample size reviews and changing the study hypothesis to address uncertain parameters, group sequential trials and multi-arm multi-stage trials to improve efficiency, and enrichment designs to maximise the chances of obtaining clear evidence about the telehealth intervention.
  
  
  CONCLUSIONS
  There is potential to address the flaws discussed in the telehealth literature through the adoption of adaptive approaches to trial design. Such designs could lead to improvements in efficiency, allow the evaluation of multiple telehealth interventions in a cost-effective way, or accurately assess a range of endpoints that are important in the overall success of a telehealth programme.
authors.affiliation: MRC Biostatistics Unit, Institute of Public Health, Forvie site, Robinson Way, Cambridge CB2 0SR, United Kingdom. Electronic address: lisa.law@mrc-bsu.cam.ac.uk.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Law
authors.affiliation: MRC Biostatistics Unit, Institute of Public Health, Forvie site, Robinson Way, Cambridge CB2 0SR, United Kingdom.
authors.forename: James M S
authors.initials: JM
authors.lastname: Wason
mesh_terms: D003362:Cost-Benefit Analysis; D006801:Humans; D015233:Models, Statistical; D012107:Research Design; D017216:Telemedicine
keywords: Adaptive design; Enrichment designs; Group sequential designs; Interim analysis; Multi-arm trials; Sample size re-estimation; Telehealth; Telemedicine