Evidence map›Paper›PMID 38317256›Full record

ArticleTrials2024

How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials.

Lauren Allen, Robert V O'Toole, Michael J Bosse, William T Obremskey, Kristin R Archer, Lisa K Cannada, Jaimie Shores, Lisa M Reider, Katherine P Frey, Anthony R Carlini and 2 more

Abstract read
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In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Lauren AllenDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA. lallen19@jhu.edu.ORCID http://orcid.org/0000-0002-8097-4555
Robert V O'TooleDepartment of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.
Michael J BosseAtrium Health Carolinas Medical Center, Charlotte, NC, 28204, USA.
William T ObremskeyDepartment of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Kristin R ArcherDepartment of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Lisa K CannadaNovant Health Orthopedic Fracture Clinic, Charlotte, NC, 28211, USA.
Jaimie ShoresSchool of Medicine, Johns Hopkins University, Baltimore, MD, 21287, USA.
Lisa M ReiderDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA.
Katherine P FreyDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA.
Anthony R CarliniDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA.
Elena D StaguhnDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA.
Renan C CastilloDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, 415 North Washington Street, Baltimore, MD, 21205, USA.

Funding

Reliability and Responsiveness of PROMIS tools in Orthopaedic Trauma PatientsR01AR064066 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI CASTILLO, RENAN C · 2012 to 2015
$1.4M
NIAMS NIH HHS R01 AR064066NIAMS NIH HHS R01AR064066
6 · The paper itself

Abstract

backgroundMulticenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment.

methodsThis retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs.

resultsNo study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible.

conclusionsOur data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner.

trial registrationPlease see Table 1 for individual trial registration numbers and dates of registration.

Indexed as

BudgetsClinical Trials as TopicCost-Benefit AnalysisHumansMulticenter Studies as TopicObservational Studies as TopicProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesFinancial managementMulticenter trialsResearch operations

Identifiers

PMID38317256
PMCPMC10840249

What OpenQuestion holds

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LicenceCC BY
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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.