Patrick T Donahue1, George Grove2, Chelsea Stillman2, Chaeryon Kang2, Jeffrey Burns3, Charles H Hillman4, Arthur F Kramer5, Edward McAuley6, Eric Vidoni3, Kirk I Erickson7. 1. University of Pittsburgh, Pittsburgh, PA, USA; Johns Hopkins University, Baltimore, MD, USA. Electronic address: ptd3@pitt.edu. 2. University of Pittsburgh, Pittsburgh, PA, USA. 3. University of Kansas Medical Center, Kansas City, MO, USA. 4. Northeastern University, Boston, MA, USA. 5. Northeastern University, Boston, MA, USA; University of Illinois, Champaign, IL, USA. 6. University of Illinois, Champaign, IL, USA. 7. University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: kiericks@pitt.edu.
Abstract
INTRODUCTION: Supervised exercise interventions are expensive and time intensive. However, there are financial costs to consider in addition to the intervention itself, namely: advertising and recruitment, outcome assessments, and other trial-related costs. OBJECTIVES: In this analysis, we examine the financial costs associated with the administration of Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) to quantify the costs associated with large exercise intervention trials and to provide future investigators with financial estimates if they wish to pursue studies of a similar design. METHODS: Cost per randomized participant were calculated in four areas: (1) advertising and recruitment, (2) outcome assessments, (3) delivery of the intervention, and (4) other trial-related expenses. Overall trial costs associated with data analysis, faculty salaries, and indirect costs were estimated as well. RESULTS: The total cost per randomized participant was estimated to be $16,494. Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs. Neuroimaging assessments (MRI & PET) cost $8247 per randomized participant, accounting for two-thirds (67%) of outcome assessment costs and half (50%) of per-participant costs. CONCLUSION: Large clinical trials of exercise are expensive (~$21 million), particularly when administering several visits to assess study aims. Outcome assessments, specifically those involving neuroimaging, accounted for a significant proportion of total costs in this analysis. Future investigators must budget accordingly if they wish to conduct a comprehensive, multi-site exercise intervention trial that examines numerous physiological and psychological outcomes.
INTRODUCTION: Supervised exercise interventions are expensive and time intensive. However, there are financial costs to consider in addition to the intervention itself, namely: advertising and recruitment, outcome assessments, and other trial-related costs. OBJECTIVES: In this analysis, we examine the financial costs associated with the administration of Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) to quantify the costs associated with large exercise intervention trials and to provide future investigators with financial estimates if they wish to pursue studies of a similar design. METHODS: Cost per randomized participant were calculated in four areas: (1) advertising and recruitment, (2) outcome assessments, (3) delivery of the intervention, and (4) other trial-related expenses. Overall trial costs associated with data analysis, faculty salaries, and indirect costs were estimated as well. RESULTS: The total cost per randomized participant was estimated to be $16,494. Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs. Neuroimaging assessments (MRI & PET) cost $8247 per randomized participant, accounting for two-thirds (67%) of outcome assessment costs and half (50%) of per-participant costs. CONCLUSION: Large clinical trials of exercise are expensive (~$21 million), particularly when administering several visits to assess study aims. Outcome assessments, specifically those involving neuroimaging, accounted for a significant proportion of total costs in this analysis. Future investigators must budget accordingly if they wish to conduct a comprehensive, multi-site exercise intervention trial that examines numerous physiological and psychological outcomes.
Authors: Kirk I Erickson; George A Grove; Jeffrey M Burns; Charles H Hillman; Arthur F Kramer; Edward McAuley; Eric D Vidoni; James T Becker; Meryl A Butters; Katerina Gray; Haiqing Huang; John M Jakicic; M Ilyas Kamboh; Chaeryon Kang; William E Klunk; Phil Lee; Anna L Marsland; Joseph Mettenburg; Renee J Rogers; Chelsea M Stillman; Bradley P Sutton; Amanda Szabo-Reed; Timothy D Verstynen; Jennifer C Watt; Andrea M Weinstein; Mariegold E Wollam Journal: Contemp Clin Trials Date: 2019-08-26 Impact factor: 2.226
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Authors: Erik J Groessl; Robert M Kaplan; Steven N Blair; W Jack Rejeski; Jeffrey A Katula; Abby C King; Roger A Fielding; Nancy W Glynn; Marco Pahor Journal: J Phys Act Health Date: 2009-11
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Authors: Eric D Vidoni; Amanda Szabo-Reed; Chaeryon Kang; Ashley R Shaw; Jaime Perales-Puchalt; George Grove; Morgan Hamill; Donovan Henry; Jeffrey M Burns; Charles Hillman; Arthur F Kramer; Edward McAuley; Kirk I Erickson Journal: Contemp Clin Trials Commun Date: 2020-10-09