University Library
  • Login
A gateway to Melbourne's research publications
Minerva Access is the University's Institutional Repository. It aims to collect, preserve, and showcase the intellectual output of staff and students of the University of Melbourne for a global audience.
View Item 
  • Minerva Access
  • Medicine, Dentistry & Health Sciences
  • Melbourne Medical School
  • Medical Education
  • Medical Education - Research Publications
  • View Item
  • Minerva Access
  • Medicine, Dentistry & Health Sciences
  • Melbourne Medical School
  • Medical Education
  • Medical Education - Research Publications
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

    Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

    Thumbnail
    Download
    Published version (383.7Kb)

    Citations
    Scopus
    Web of Science
    Altmetric
    3
    3
    Author
    Zielinski, SM; Viveiros, H; Heetveld, MJ; Swiontkowski, MF; Bhandari, M; Patka, P; Van Lieshout, EMM
    Date
    2012-01-08
    Source Title
    Trials
    Publisher
    BIOMED CENTRAL LTD
    University of Melbourne Author/s
    Bucknill, Andrew
    Affiliation
    Medical Education
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Zielinski, S. M., Viveiros, H., Heetveld, M. J., Swiontkowski, M. F., Bhandari, M., Patka, P. & Van Lieshout, E. M. M. (2012). Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience. TRIALS, 13 (1), https://doi.org/10.1186/1745-6215-13-5.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/256306
    DOI
    10.1186/1745-6215-13-5
    Abstract
    BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813.

    Export Reference in RIS Format     

    Endnote

    • Click on "Export Reference in RIS Format" and choose "open with... Endnote".

    Refworks

    • Click on "Export Reference in RIS Format". Login to Refworks, go to References => Import References


    Collections
    • Minerva Elements Records [45770]
    • Medical Education - Research Publications [497]
    Minerva AccessDepositing Your Work (for University of Melbourne Staff and Students)NewsFAQs

    BrowseCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects
    My AccountLoginRegister
    StatisticsMost Popular ItemsStatistics by CountryMost Popular Authors