Evidence map›Paper›PMID 31604788›Full record

Observational studyBMJ open2019

Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis.

Nathan N O'Hara, Yasmin Degani, Debra Marvel, David Wells, C Daniel Mullins, Stephen Wegener, Katherine Frey, Tara Joseph, Jonathan Hurst, Renan Castillo and 2 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02984384 (PREVENTion of Clot in Orthopaedic Trauma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02984384 phase3completednot on this map

PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients

TypeinterventionalSponsorMajor Extremity Trauma Research ConsortiumRan2017 to 2022Enrolled12,424ConditionsBlood Clot, TraumaArmsAcetylsalicylic acid, Low Molecular Weight Heparin (LMWH)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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.

Nathan N O'HaraDepartment of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA nohara@som.umaryland.edu.ORCID 0000-0003-0537-3474
Yasmin DeganiDepartment of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Debra MarvelPREVENT CLOT Stakeholder Committee, Baltimore, Maryland, USA.
David WellsPREVENT CLOT Stakeholder Committee, Baltimore, Maryland, USA.
C Daniel MullinsDepartment of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Stephen WegenerDepartment of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Katherine FreyDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Tara JosephDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jonathan HurstDepartment of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Renan CastilloDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Robert V O'TooleDepartment of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA.
PREVENT CLOT Stakeholder Committee

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe study aimed to assess systematic differences in the characteristics of patients that consented for the trial compared with the broader pool of eligible patients in a large, pragmatic orthopaedic trauma trial.

designA retrospective observational study performed from April 2017 to March 2018.

settingAcademic trauma centre in Baltimore, USA.

participantsThere were 642 eligible adult trial participants with an operative fracture to the appendicular skeleton and were indicated for blood clot prophylaxis. The median age of the sample was 50 years (IQR: 31-63), and 60% were male. PRIMARY OUTCOME MEASURE: The primary outcome was the refusal to enrol in the trial. Demographic and injury covariates were included in iterations of latent class models. The final model was selected based on a minimum Bayesian information criterion.

resultsThe final model identified three clusters with five covariates predictive of cluster membership (age, neighbourhood-based socioeconomic status, alcohol use, multiple fractures, multiple surgeries). The three clusters were associated with 22% (Cluster 1), 38% (Cluster 2) and 62% (Cluster 3) refusal rates, respectively. Members of Cluster 3 (n=84) were most commonly between 66 and 80 years of age (49% vs 6% (Cluster 1) and 21% (Cluster 2)), of high neighbourhood-based socioeconomic status (85% vs 63% (Cluster 1) and 8% (Cluster 2)), with isolated fractures (100% vs 80% (Cluster 1) and 92% (Cluster 2)), and were less likely to have multiple surgeries compared with the other clusters (28% vs 47% (Cluster 1) and 35% (Cluster 2)).

conclusionIn this study, the likelihood of refusing to participate in the trial ranged from 22% to 62% in the three identified clusters. Elderly age, high socioeconomic status, and less severe injuries defined the cluster that was most likely to refuse trial participation. TRIAL REGISTRATION NUMBER: NCT02984384.

Indexed as

AdultClinical Trials as TopicFemaleFractures, BoneHumansLatent Class AnalysisMaleMiddle AgedOrthopedic ProceduresRefusal to ParticipateRetrospective Studiesclinical trialsthromboembolismtrauma management

Identifiers

PMID31604788
PMCPMC6797323

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.