Evidence map›Paper›PMID 33857678›Full record

ArticleContemporary clinical trials2021

Estimating the financial costs associated with a phase III, multi-site exercise intervention trial: Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE).

Patrick T Donahue, George Grove, Chelsea Stillman, Chaeryon Kang, Jeffrey Burns, Charles H Hillman, Arthur F Kramer, Edward McAuley, Eric Vidoni, Kirk I Erickson

Open access · greenAbstract read
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Patrick T DonahueUniversity of Pittsburgh, Pittsburgh, PA, USA; Johns Hopkins University, Baltimore, MD, USA. Electronic address: ptd3@pitt.edu.
George GroveUniversity of Pittsburgh, Pittsburgh, PA, USA.
Chelsea StillmanUniversity of Pittsburgh, Pittsburgh, PA, USA.
Chaeryon KangUniversity of Pittsburgh, Pittsburgh, PA, USA.
Jeffrey BurnsUniversity of Kansas Medical Center, Kansas City, MO, USA.
Charles H HillmanNortheastern University, Boston, MA, USA.
Arthur F KramerNortheastern University, Boston, MA, USA; University of Illinois, Champaign, IL, USA.
Edward McAuleyUniversity of Illinois, Champaign, IL, USA.
Eric VidoniUniversity of Kansas Medical Center, Kansas City, MO, USA.
Kirk I EricksonUniversity of Pittsburgh, Pittsburgh, PA, USA. Electronic address: kiericks@pitt.edu.
University of Pittsburgh · USUniversity of Kansas Medical Center · USNortheastern University · USUniversity of Illinois Urbana-Champaign · US

Funding

Investigating Gains in Neurocognition in an Intervention Trial of Exercise SupplementR01AG053952 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BURNS, JEFFREY MURRAY, ERICKSON, KIRK I · 2016 to 2020
$27.5M
EPIDEMIOLOGY AND BIOSTATISTICS OF AGINGT32AG000247 · NIA · JOHNS HOPKINS UNIVERSITY · PI Karen J. Bandeen-Roche · 1996 to 2026
$13.2M
NIA NIH HHS R01 AG053952NIA NIH HHS T32 AG000247
6 · The paper itself

Abstract

introductionSupervised 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.

objectivesIn 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.

methodsCost 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.

resultsThe 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.

conclusionLarge 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.

Indexed as

ExerciseNeuroimagingAdvertisingClinical Trials, Phase III as TopicCost-Benefit AnalysisExercise TherapyHumansMagnetic Resonance ImagingRandomized Controlled Trials as TopicAerobic exerciseAgingCognitionNeuroimagingPhysical activityRandomized clinical trial

Identifiers

PMID33857678
PMCPMC8172438
OpenAlexW3156002127

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.