Evidence map›Paper›PMID 22225733›Full record

Trial reportTrials2012

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

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00761813 (Fixation Using Alternative Implants for the Treatment of Hip Fractures), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT00761813 nacompletednot on this map

Fixation Using Alternative Implants for the Treatment of Hip Fractures: A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures

TypeinterventionalSponsorUniversity of MinnesotaRan2009 to 2016Enrolled1,108ConditionsFemoral Neck FracturesArmsOpen reduction internal fixation (ORIF) with single sliding hip screw, ORIF with multiple cancellous screws
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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

8 authors.

Stephanie M ZielinskiDept, of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands.
Helena Viveiros
Martin J Heetveld
Marc F Swiontkowski
Mohit Bhandari
Peter Patka
Esther M M Van Lieshout
FAITH trial investigators

Funding

Fixation using Alternative Implants for the Treatment of Hip Fractures: A Multi-cR01AR055267 · NIAMS · UNIVERSITY OF MINNESOTA · PI SWIONTKOWSKI, MARC F. · 2008 to 2012
$1.2M
Canadian Institutes of Health Research 177466NIAMS NIH HHS 1R01-AR055267-01A1
6 · The paper itself

Abstract

backgroundSurgeons 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.

methodsDetails 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.

resultsMedian 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).

conclusionsIn 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 registrationClinicalTrials.gov: NCT00761813.

Indexed as

Research DesignAdministrative PersonnelCanadaCooperative BehaviorEfficiency, OrganizationalEthics Committees, ResearchFracture FixationHip FracturesHumansNetherlandsPatient SelectionResearch PersonnelResearch Support as TopicSample SizeTime FactorsUnited States

Identifiers

PMID22225733
PMCPMC3275506

What OpenQuestion holds

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Registered trials

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.