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

Stephanie M Zielinski; Helena Viveiros; Martin J Heetveld; Marc F Swiontkowski; Mohit Bhandari; Peter Patka; Esther M M Van Lieshout; FAITH trial investigators

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

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

Authors

Stephanie M Zielinski¹, Helena Viveiros, Martin J Heetveld, Marc F Swiontkowski, Mohit Bhandari, Peter Patka, Esther M M Van Lieshout; FAITH trial investigators

Collaborators

FAITH trial investigators:
Mohit Bhandari, Philip J Devereaux, Gordon Guyatt, Martin J Heetveld, Kyle Jeray, Susan Liew, Martin J Richardson, Emil H Schemitsch, Marc Swiontkowski, Paul Tornetta 3rd, Stephen Walter, Mohit Bhandari, Sheila Sprague, Helena Viveiros Nicole Simunovic, Diane Heels-Ansdell, Lisa Buckingham, Aravin Duraikannan, Marc F Swiontkowski, Julie Agel, Esther M M Van Lieshout, Stephanie M Zielinski, J Carel Goslings, Robert Haverlag, Kees Jan Ponsen, Peter Patka, Martin G Eversdijk, Rolf Peters, Dennis den Hartog, Oscar J F van Waes, Pim Oprel, Piet A R de Rijcke, C L Koppert, Steven E Buijk, Richard P R Groenendijk, I Dawson, G W M Tetteroo, Milko M M Bruijninckx, Pascal G Doornebosch, E J R deGraaf, Martin J Heetveld, Gijs A Visser, Heyn Stockmann, Rob Silvis, J P Snellen, A Rijbroek, Joris J G Scheepers, Erik G J Vermeulen, M P C Siroen, Ronald Vuylsteke, H L F Brom, H Ryna, Steven J Rhemrev, C H R Bosman, Alexander de Mol van Otterloo, Jochem Hoogendoorn, Alexander C de Vries, Sven A G Meylaerts, Gert R Roukema, H Josaputra, Paul Keller, P P de Rooij, H Kuiken, Han Boxma, B I Cleffken, Ronald Liem, Rudolf W Poolman, Maarten P Simons, Frank H W M van der Heijden, W J Willems, Frank R A J de Meulemeester, Cor P van der Hart, Kahn Turckan, Sebastiaan Festen, F de Nies, Robert Haverlag, Nico J M Out, J Bosma, Maarten van der Elst, Carmen C van der Pol, Martijne van 't Riet, T M Karsten, M R de Vries, Laurents P S Stassen, Niels W L Schep, G B Schmidt, W H Hoffman, Michiel J M Segers, Jacco A C Zijl, Bart Verhoeven, Anke B Smits, J P P M de Vries, Bram Fioole, H van der Hoeven, Evert B M Theunissen, Tammo S de Vries Reilingh, Lonneke Govaert, Philippe Wittich, Maurits de Brauw, Jan Wille, Peter M N Y M Go, Ewan D Ritchie, R N Wessel, Eric R Hammacher, Michiel H J Verhofstad, Joost Meijer, Teun van Egmond, Frank H W M van der Heijden, Igor van der Brand, Harm M van der Vis, Martin Campo, Ronald Verhagen, G H R Albers, A Zurcher, A van Kampen, Jan Biert, Arie B van Vugt, Michael J R Edwards, Taco J Blokhuis, Jan Paul M Frölke, M G Geeraedts, J W M Gardeniers, Edward T C H Tan, L M S J Poelhekke, Waal Malefijt, Bart Schreurs, Rogier K J Simmermacher, Jeroen van Mulken, Karlijn van Wessem, Taco J Blokhuis, Steven M van Gaalen, Luke P H Leenen, Maarten W G A Bronkhorst, O R Guicherit, Frede Frihagen, Lars Nordsletten, Oydna Stoen, Kine Brekke, Kevin Tetsworth, Patrick Weinrauch, Paul Pincus, Geoff Donald, Steven yang, Brett Halliday, Trevor Gervais, Michael Holt, Annette Flynn, Marinis Pirpiris, David Love, Andrew Bucknill, Richard J Farrugia, Susan Liew, Adam Dowrick, Craig Donohue, Harvinder Bedi, Doug Li, Elton Edwards, Steven Csongvay, Russell Miller, Otis Wang, Andrew Chia, Russell Miller, Arvind Jain, Mathan Mammen, Zoe Murdoch, Claire Sage, Anil Kumar Jain, Amite Pankaj, Ajay Pal Singh, Rodrigo Pesantez, Adriana Martinez, Catherine Novoa, Richard E Buckley, Paul Duffy, Robert Korley, Kelly Johnston, Shannon Puloski, Kimberly Carcary, Victoria Avram, Ryan Bicknell, Jeff Yach, Davide Bardana, Sue Lambert, David W Sanders, Jamie Howard, Mark Macleod, C T Bartly, Christina Tieszer, Devin Peterson, Paul Zalzal, Victor Maumetz, Heather Brien, Brad Weening, Eugene K Wai, Darren Roffey, Robert McCormack, Trevor Stone, Bertrand Perey, Darius Viskontas, Dory Boyer, Bert Perey, Mauri Zomar, Karyn Moon, Amber Oatt, Emil H Schemitsch, Michael McKee, Jeremy Hall, Henry Ahn, Milena R Vicente, Lisa M Wild, Hans J Kreder, David J G Stephen, Markku Nousianinen, Ria Cagaanan, Monica Kunz, Khalid Syed, Tania Azad, Chad Coles, Ross Leighton, David Johnstone, Mark Glazebrook, David Alexander, Kelly Trask, Gwendolyn Dobbin, Todd M Oliver, Vicky Jones, James Ronan, Paul Tornetta 3rd, Desmond T Brown, Hope Carlilse, Lisa Shaughnessy, John Schwappach, Craig A Davis, Peter Weingarten, Stewart Weinerman, Heike Newman, Janell Baker, Kieran Browner, Meghan Hurley, Robert Zura, Maria J Manson, Kyle Jeray, David Goetz, Scott J Broderick, Scott Porter, Thomas Pace, Stephanie L Tanner, Becky Snider, Andrew H Schmidt, Jonathan Haas, David Templeman, Jerald R Westberg, Brian Mullis, J P Ertl, Karl Shively, Valda Frizzel, Andrew J Marcantonio, Richard Iorio, Margaret Lobo, Michael Kain, Lawrence Specht, John Garfi, Michael J Prayson, Craig Davis, Richard Laughlin, Joe Rubino, Mathew Lawless, Matt DiPaola, Chris Gaydon, Liz Dulaney, Heather A Vallier, John Wilber, John Sontich, Brendan Patterson, Andrea Dolenc, Chalitha Robinson, Roger Wilber, Charles J DePaolo, Rachel Alosky, E Leslie Shell, Jonathan P Keeve, Chris Anderson, Michael McDonald, Jodi Hoffman, Joseph Baele, Tim Weber, Matt Edison, Dana Musapatika, Clifford Jones, James Ringler, Terrance Endres, Martin Gelbke, Michael Jabara, Debra L Sietsema, Susan M Engerman, Julie A Switzer, Mangnai Li, Scott Marston, Peter Cole, Sandy X Vang, Amy Foley, Jessica McBeth, Curt Comstock, Navid Ziran, James Shaer, Barbara Hileman, David Karges, Lisa Cannada, Djoldas, Kuldjanov, John Tracy Watson, Emily Mills, Tiffany Simon, Amr Abdelgawad, Juan Shunia, Mark Jenkins, Mimi Zumwalt, Amanda West Romero, Jason Lowe, Jessica Goldstein, David P Zamorano, Deanna Lawson, Michael Archdeacon, John Wyrick, Shelley Hampton, Courtland G Lewis, Arben Ademi, Raymond Sullivan, Stephanie Caminiti, Matthew Graves, Lori Smith, Gregory J Della Rocca, Brett D Crist, Yvonne Murtha, Linda K Anderson, Toni K Kliewer, Melinda K McPherson, Kelly M Sullivan, Carlos Sagebien, Patricia Seuffert, Samir Mehta, John Esterhai, Jaimo Ahn, Fotios Tjoumakaris, Annamarie D Horan, Christine Kaminski, Ivan Tarkin, Peter Siska, Arlene Luther, James Irrgang, Dana Farrell, John T Gorczyca, Jonathan M Gross, Stephen Lloyd Kates, Jen Colosi, Nancy Hibsch, Krista Noble, Animesh Agarwal, Rebecca Wright, Sam Houston, Joseph R Hsu, James R Ficke, Matthew A Napierala, Michael T Charlton, Mary K Fan, William T Obremskey, Justin E Richards, Kenya Robinson

Affiliation

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.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Administrative Personnel / economics
Administrative Personnel / organization & administration*
Canada
Cooperative Behavior
Efficiency, Organizational
Ethics Committees, Research
Fracture Fixation / economics
Fracture Fixation / methods*
Hip Fractures / economics
Hip Fractures / surgery*
Humans
Netherlands
Patient Selection
Research Design*
Research Personnel / economics
Research Personnel / organization & administration*
Research Support as Topic
Sample Size
Time Factors
United States

Associated data

ClinicalTrials.gov/NCT00761813

Abstract

Publication types

MeSH terms

Associated data

Grants and funding