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Trials. 2012 Jan 8;13:5. doi: 10.1186/1745-6215-13-5.

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

Collaborators (367)

Bhandari M, Devereaux PJ, Guyatt G, Heetveld MJ, Jeray K, Liew S, Richardson MJ, Schemitsch EH, Swiontkowski M, Tornetta P 3rd, Walter S, Bhandari M, Sprague S, Simunovic HV, Heels-Ansdell D, Buckingham L, Duraikannan A, Swiontkowski MF, Agel J, Van Lieshout EM, Zielinski SM, Goslings JC, Haverlag R, Ponsen KJ, Patka P, Eversdijk MG, Peters R, den Hartog D, van Waes OJ, Oprel P, de Rijcke PA, Koppert CL, Buijk SE, Groenendijk RP, Dawson I, Tetteroo GW, Bruijninckx MM, Doornebosch PG, deGraaf EJ, Heetveld MJ, Visser GA, Stockmann H, Silvis R, Snellen JP, Rijbroek A, Scheepers JJ, Vermeulen EG, Siroen MP, Vuylsteke R, Brom HL, Ryna H, Rhemrev SJ, Bosman CH, de Mol van Otterloo A, Hoogendoorn J, de Vries AC, Meylaerts SA, Roukema GR, Josaputra H, Keller P, de Rooij PP, Kuiken H, Boxma H, Cleffken BI, Liem R, Poolman RW, Simons MP, van der Heijden FH, Willems WJ, de Meulemeester FR, van der Hart CP, Turckan K, Festen S, de Nies F, Haverlag R, Out NJ, Bosma J, van der Elst M, van der Pol CC, van 't Riet M, Karsten TM, de Vries MR, Stassen LP, Schep NW, Schmidt GB, Hoffman WH, Segers MJ, Zijl JA, Verhoeven B, Smits AB, de Vries JP, Fioole B, van der Hoeven H, Theunissen EB, de Vries Reilingh TS, Govaert L, Wittich P, de Brauw M, Wille J, Go PM, Ritchie ED, Wessel RN, Hammacher ER, Verhofstad MH, Meijer J, van Egmond T, van der Heijden FH, van der Brand I, van der Vis HM, Campo M, Verhagen R, Albers GH, Zurcher A, van Kampen A, Biert J, van Vugt AB, Edwards MJ, Blokhuis TJ, Frölke JP, Geeraedts MG, Gardeniers JW, Tan ET, Poelhekke LM, Malefijt W, Schreurs B, Simmermacher RK, van Mulken J, van Wessem K, Blokhuis TJ, van Gaalen SM, Leenen LP, Bronkhorst MW, Guicherit OR, Frihagen F, Nordsletten L, Stoen O, Brekke K, Tetsworth K, Weinrauch P, Pincus P, Donald G, yang S, Halliday B, Gervais T, Holt M, Flynn A, Pirpiris M, Love D, Bucknill A, Farrugia RJ, Liew S, Dowrick A, Donohue C, Bedi H, Li D, Edwards E, Csongvay S, Miller R, Wang O, Chia A, Miller R, Jain A, Mammen M, Murdoch Z, Sage C, Jain AK, Pankaj A, Singh AP, Pesantez R, Martinez A, Novoa C, Buckley RE, Duffy P, Korley R, Johnston K, Puloski S, Carcary K, Avram V, Bicknell R, Yach J, Bardana D, Lambert S, Sanders DW, Howard J, Macleod M, Bartly CT, Tieszer C, Peterson D, Zalzal P, Maumetz V, Brien H, Weening B, Wai EK, Roffey D, McCormack R, Stone T, Perey B, Viskontas D, Boyer D, Perey B, Zomar M, Moon K, Oatt A, Schemitsch EH, McKee M, Hall J, Ahn H, Vicente MR, Wild LM, Kreder HJ, Stephen DJ, Nousianinen M, Cagaanan R, Kunz M, Syed K, Azad T, Coles C, Leighton R, Johnstone D, Glazebrook M, Alexander D, Trask K, Dobbin G, Oliver TM, Jones V, Ronan J, Tornetta P 3rd, Brown DT, Carlilse H, Shaughnessy L, Schwappach J, Davis CA, Weingarten P, Weinerman S, Newman H, Baker J, Browner K, Hurley M, Zura R, Manson MJ, Jeray K, Goetz D, Broderick SJ, Porter S, Pace T, Tanner SL, Snider B, Schmidt AH, Haas J, Templeman D, Westberg JR, Mullis B, Ertl JP, Shively K, Frizzel V, Marcantonio AJ, Iorio R, Lobo M, Kain M, Specht L, Garfi J, Prayson MJ, Davis C, Laughlin R, Rubino J, Lawless M, DiPaola M, Gaydon C, Dulaney L, Vallier HA, Wilber J, Sontich J, Patterson B, Dolenc A, Robinson C, Wilber R, DePaolo CJ, Alosky R, Shell EL, Keeve JP, Anderson C, McDonald M, Hoffman J, Baele J, Weber T, Edison M, Musapatika D, Jones C, Ringler J, Endres T, Gelbke M, Jabara M, Sietsema DL, Engerman SM, Switzer JA, Li M, Marston S, Cole P, Vang SX, Foley A, McBeth J, Comstock C, Ziran N, Shaer J, Hileman B, Karges D, Cannada L, Djoldas, Kuldjanov, Watson JT, Mills E, Simon T, Abdelgawad A, Shunia J, Jenkins M, Zumwalt M, Romero AW, Lowe J, Goldstein J, Zamorano DP, Lawson D, Archdeacon M, Wyrick J, Hampton S, Lewis CG, Ademi A, Sullivan R, Caminiti S, Graves M, Smith L, Della Rocca GJ, Crist BD, Murtha Y, Anderson LK, Kliewer TK, McPherson MK, Sullivan KM, Sagebien C, Seuffert P, Mehta S, Esterhai J, Ahn J, Tjoumakaris F, Horan AD, Kaminski C, Tarkin I, Siska P, Luther A, Irrgang J, Farrell D, Gorczyca JT, Gross JM, Kates SL, Colosi J, Hibsch N, Noble K, Agarwal A, Wright R, Houston S, Hsu JR, Ficke JR, Napierala MA, Charlton MT, Fan MK, Obremskey WT, Richards JE, Robinson K.

Author information

1
Dept, of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands.

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.

PMID:
22225733
PMCID:
PMC3275506
DOI:
10.1186/1745-6215-13-5
[Indexed for MEDLINE]
Free PMC Article

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