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

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

Stephanie M. Zielinski, Helena Viveiros, Martin J. Heetveld, Marc F. Swiontkowski, Mohit Bhandari, Peter Patka, Esther M.M. Van Lieshout

Orthopaedic Surgery

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

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.

Original language	English (US)
Article number	5
Journal	Trials
Volume	13
DOIs	https://doi.org/10.1186/1745-6215-13-5
State	Published - Jan 8 2012

Bibliographical note

Funding Information:
The trial start-up period was statistically significantly shorter in the Netherlands (median 41 days) than in the US and Canada (87 and 232 days). In these latter two countries contract negotiations with participating sites had to take place during the trial start-up period, whereas this procedure was not applicable in the Netherlands. Furthermore, research assistants from Canada and the US frequently reported a long period between grant approval and official release of the funds. These aspects related to the per patient payment strategy applied in Canada and the US slowed the trial start-up process in these countries. In the Netherlands contract negotiations or per patient payments were unnecessary, as all tasks were performed by the central study coordinator, not resulting in delay. The assistance of the Dutch central trial coordinator in trial start-up activities (e.g. distributing study materials, giving start-up presentations) may also have contributed to a more efficient and speedy trial start-up.

Funding Information:
Steering Committee Mohit Bhandari (chair), Philip J. Devereaux, Gordon Guyatt, Martin J. Heetveld, Kyle Jeray, Susan Liew, Martin J. Richardson, Emil H. Schemitsch, Marc Swiontkowski, Paul Tornetta III, Stephen Walter. Methods Centre and Coordination of Canadian/International Sites Supported under the PSI and CIHR Grants McMaster University, Hamilton, ON: Mohit Bhandari, Sheila Sprague, Helena Viveiros Nicole Simunovic, Diane Heels-Ansdell, Lisa Buckingham, Aravin Duraikannan. Country Coordination of US Sites Supported under the NIH Grant University of Minnesota, Minneapolis, MN: Marc F. Swiontkowski, Julie Agel. Country Coordination of Dutch Sites Supported under the Fonds Nuts Ohra Grant Erasmus MC, Rotterdam: Esther M.M. Van Lieshout, Stephanie M. Zielinski. Investigators - The Netherlands (site principal investigator is marked with an asterisk) Academic Medical Center, Amsterdam: J Carel Goslings*, Robert Haverlag, Kees Jan Ponsen. Erasmus MC, University Medical Center Rotterdam, Rotterdam: Peter Patka*, Martin G. Eversdijk, Rolf Peters, Dennis den Hartog, Oscar J.F. van Waes, Pim Oprel. IJsselland Ziekenhuis, Capelle aan den IJssel: 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. Kennemer Gasthuis, Haarlem: 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. Medisch Centrum Haaglanden, Den Haag: Steven J. Rhemrev*, C.H.R. Bosman, Alexander de Mol van Otterloo, Jochem Hoogendoorn, Alexander C. de Vries, Sven A.G. Meylaerts. Maasstad Ziekenhuis, Rotterdam: Gert R Roukema*, H. Josaputra, Paul Keller, P.P. de Rooij, H. Kuiken, Han Boxma, B.I. Cleffken, Ronald Liem. Onze Lieve Vrouwe Gasthuis, Amsterdam: 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. Reinier de Graaf Gasthuis, Delft: 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. St. Antonius Ziekenhuis, Nieuwegein: 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. St. Elisabeth Ziekenhuis, Tilburg: Michiel H.J. Verhofstad*, Joost Meijer, Teun van Egmond, Frank H.W.M. van der Heijden, Igor van der Brand. Tergooi Ziekenhuizen, Hilversum: Harm M van der Vis*, Martin Campo, Ronald Verhagen, G.H.R. Albers, A Zurcher. University Medical Center St. Radboud, Nijmegen: A van Kampen, Jan Biert*, Arie B. van Vugt, Michael J.R. Edwards, Taco J. Blokhuis, Jan Paul M. Frölke, L. M.G. Geeraedts, J.W.M. Gardeniers, Edward T.C.H. Tan, L.M.S.J. Poelhekke, M.C. de Waal Malefijt, Bart Schreurs.

Keywords

Follow-up
Inclusion
Management
Randomized controlled trial
Trial coordinator
Trial performance

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10.1186/1745-6215-13-5

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@article{78d8cf7b9d804e38988e80646f850509,

title = "Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: The FAITH trial experience",

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.",

keywords = "Follow-up, Inclusion, Management, Randomized controlled trial, Trial coordinator, Trial performance",

author = "Zielinski, {Stephanie M.} and Helena Viveiros and Heetveld, {Martin J.} and Swiontkowski, {Marc F.} and Mohit Bhandari and Peter Patka and {Van Lieshout}, {Esther M.M.}",

note = "Funding Information: The trial start-up period was statistically significantly shorter in the Netherlands (median 41 days) than in the US and Canada (87 and 232 days). In these latter two countries contract negotiations with participating sites had to take place during the trial start-up period, whereas this procedure was not applicable in the Netherlands. Furthermore, research assistants from Canada and the US frequently reported a long period between grant approval and official release of the funds. These aspects related to the per patient payment strategy applied in Canada and the US slowed the trial start-up process in these countries. In the Netherlands contract negotiations or per patient payments were unnecessary, as all tasks were performed by the central study coordinator, not resulting in delay. The assistance of the Dutch central trial coordinator in trial start-up activities (e.g. distributing study materials, giving start-up presentations) may also have contributed to a more efficient and speedy trial start-up. Funding Information: Steering Committee Mohit Bhandari (chair), Philip J. Devereaux, Gordon Guyatt, Martin J. Heetveld, Kyle Jeray, Susan Liew, Martin J. Richardson, Emil H. Schemitsch, Marc Swiontkowski, Paul Tornetta III, Stephen Walter. Methods Centre and Coordination of Canadian/International Sites Supported under the PSI and CIHR Grants McMaster University, Hamilton, ON: Mohit Bhandari, Sheila Sprague, Helena Viveiros Nicole Simunovic, Diane Heels-Ansdell, Lisa Buckingham, Aravin Duraikannan. Country Coordination of US Sites Supported under the NIH Grant University of Minnesota, Minneapolis, MN: Marc F. Swiontkowski, Julie Agel. Country Coordination of Dutch Sites Supported under the Fonds Nuts Ohra Grant Erasmus MC, Rotterdam: Esther M.M. Van Lieshout, Stephanie M. Zielinski. Investigators - The Netherlands (site principal investigator is marked with an asterisk) Academic Medical Center, Amsterdam: J Carel Goslings*, Robert Haverlag, Kees Jan Ponsen. Erasmus MC, University Medical Center Rotterdam, Rotterdam: Peter Patka*, Martin G. Eversdijk, Rolf Peters, Dennis den Hartog, Oscar J.F. van Waes, Pim Oprel. IJsselland Ziekenhuis, Capelle aan den IJssel: 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. Kennemer Gasthuis, Haarlem: 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. Medisch Centrum Haaglanden, Den Haag: Steven J. Rhemrev*, C.H.R. Bosman, Alexander de Mol van Otterloo, Jochem Hoogendoorn, Alexander C. de Vries, Sven A.G. Meylaerts. Maasstad Ziekenhuis, Rotterdam: Gert R Roukema*, H. Josaputra, Paul Keller, P.P. de Rooij, H. Kuiken, Han Boxma, B.I. Cleffken, Ronald Liem. Onze Lieve Vrouwe Gasthuis, Amsterdam: 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. Reinier de Graaf Gasthuis, Delft: Maarten van der Elst*, Carmen C. van der Pol, Martijne van {\textquoteleft}t Riet, T.M. Karsten, M.R. de Vries, Laurents P.S. Stassen, Niels W.L. Schep, G.B. Schmidt, W.H. Hoffman. St. Antonius Ziekenhuis, Nieuwegein: 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. St. Elisabeth Ziekenhuis, Tilburg: Michiel H.J. Verhofstad*, Joost Meijer, Teun van Egmond, Frank H.W.M. van der Heijden, Igor van der Brand. Tergooi Ziekenhuizen, Hilversum: Harm M van der Vis*, Martin Campo, Ronald Verhagen, G.H.R. Albers, A Zurcher. University Medical Center St. Radboud, Nijmegen: A van Kampen, Jan Biert*, Arie B. van Vugt, Michael J.R. Edwards, Taco J. Blokhuis, Jan Paul M. Fr{\"o}lke, L. M.G. Geeraedts, J.W.M. Gardeniers, Edward T.C.H. Tan, L.M.S.J. Poelhekke, M.C. de Waal Malefijt, Bart Schreurs.",

year = "2012",

month = jan,

day = "8",

doi = "10.1186/1745-6215-13-5",

language = "English (US)",

volume = "13",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

}

TY - JOUR

T1 - Central coordination as an alternative for local coordination in a multicenter randomized controlled trial

T2 - The FAITH trial experience

AU - Zielinski, Stephanie M.

AU - Viveiros, Helena

AU - Heetveld, Martin J.

AU - Swiontkowski, Marc F.

AU - Bhandari, Mohit

AU - Patka, Peter

AU - Van Lieshout, Esther M.M.

N1 - Funding Information: The trial start-up period was statistically significantly shorter in the Netherlands (median 41 days) than in the US and Canada (87 and 232 days). In these latter two countries contract negotiations with participating sites had to take place during the trial start-up period, whereas this procedure was not applicable in the Netherlands. Furthermore, research assistants from Canada and the US frequently reported a long period between grant approval and official release of the funds. These aspects related to the per patient payment strategy applied in Canada and the US slowed the trial start-up process in these countries. In the Netherlands contract negotiations or per patient payments were unnecessary, as all tasks were performed by the central study coordinator, not resulting in delay. The assistance of the Dutch central trial coordinator in trial start-up activities (e.g. distributing study materials, giving start-up presentations) may also have contributed to a more efficient and speedy trial start-up. Funding Information: Steering Committee Mohit Bhandari (chair), Philip J. Devereaux, Gordon Guyatt, Martin J. Heetveld, Kyle Jeray, Susan Liew, Martin J. Richardson, Emil H. Schemitsch, Marc Swiontkowski, Paul Tornetta III, Stephen Walter. Methods Centre and Coordination of Canadian/International Sites Supported under the PSI and CIHR Grants McMaster University, Hamilton, ON: Mohit Bhandari, Sheila Sprague, Helena Viveiros Nicole Simunovic, Diane Heels-Ansdell, Lisa Buckingham, Aravin Duraikannan. Country Coordination of US Sites Supported under the NIH Grant University of Minnesota, Minneapolis, MN: Marc F. Swiontkowski, Julie Agel. Country Coordination of Dutch Sites Supported under the Fonds Nuts Ohra Grant Erasmus MC, Rotterdam: Esther M.M. Van Lieshout, Stephanie M. Zielinski. Investigators - The Netherlands (site principal investigator is marked with an asterisk) Academic Medical Center, Amsterdam: J Carel Goslings*, Robert Haverlag, Kees Jan Ponsen. Erasmus MC, University Medical Center Rotterdam, Rotterdam: Peter Patka*, Martin G. Eversdijk, Rolf Peters, Dennis den Hartog, Oscar J.F. van Waes, Pim Oprel. IJsselland Ziekenhuis, Capelle aan den IJssel: 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. Kennemer Gasthuis, Haarlem: 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. Medisch Centrum Haaglanden, Den Haag: Steven J. Rhemrev*, C.H.R. Bosman, Alexander de Mol van Otterloo, Jochem Hoogendoorn, Alexander C. de Vries, Sven A.G. Meylaerts. Maasstad Ziekenhuis, Rotterdam: Gert R Roukema*, H. Josaputra, Paul Keller, P.P. de Rooij, H. Kuiken, Han Boxma, B.I. Cleffken, Ronald Liem. Onze Lieve Vrouwe Gasthuis, Amsterdam: 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. Reinier de Graaf Gasthuis, Delft: 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. St. Antonius Ziekenhuis, Nieuwegein: 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. St. Elisabeth Ziekenhuis, Tilburg: Michiel H.J. Verhofstad*, Joost Meijer, Teun van Egmond, Frank H.W.M. van der Heijden, Igor van der Brand. Tergooi Ziekenhuizen, Hilversum: Harm M van der Vis*, Martin Campo, Ronald Verhagen, G.H.R. Albers, A Zurcher. University Medical Center St. Radboud, Nijmegen: A van Kampen, Jan Biert*, Arie B. van Vugt, Michael J.R. Edwards, Taco J. Blokhuis, Jan Paul M. Frölke, L. M.G. Geeraedts, J.W.M. Gardeniers, Edward T.C.H. Tan, L.M.S.J. Poelhekke, M.C. de Waal Malefijt, Bart Schreurs.

PY - 2012/1/8

Y1 - 2012/1/8

N2 - 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.

AB - 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.

KW - Follow-up

KW - Inclusion

KW - Management

KW - Randomized controlled trial

KW - Trial coordinator

KW - Trial performance

UR - http://www.scopus.com/inward/record.url?scp=84855466931&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84855466931&partnerID=8YFLogxK

U2 - 10.1186/1745-6215-13-5

DO - 10.1186/1745-6215-13-5

M3 - Article

C2 - 22225733

AN - SCOPUS:84855466931

SN - 1745-6215

VL - 13

JO - Trials

JF - Trials

M1 - 5

ER -

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

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