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

PREVENT CLOT Stakeholder Committee

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: The 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. DESIGN: A retrospective observational study performed from April 2017 to March 2018. SETTING: Academic trauma centre in Baltimore, USA. PARTICIPANTS: There 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. RESULTS: The 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)). CONCLUSION: In 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.

Original languageEnglish (US)
Pages (from-to)e032631
JournalBMJ open
Volume9
Issue number10
DOIs
StatePublished - Oct 11 2019

Fingerprint

Social Class
Orthopedics
Clinical Trials
Wounds and Injuries
Baltimore
Trauma Centers
Skeleton
Observational Studies
Thrombosis
Retrospective Studies
Alcohols
Demography
Multiple Fractures

Keywords

  • clinical trials
  • thromboembolism
  • trauma management

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis. / PREVENT CLOT Stakeholder Committee.

In: BMJ open, Vol. 9, No. 10, 11.10.2019, p. e032631.

Research output: Contribution to journalArticle

@article{1cd388d9c3f44b7baf450ea2474acc35,
title = "Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis",
abstract = "OBJECTIVE: The 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. DESIGN: A retrospective observational study performed from April 2017 to March 2018. SETTING: Academic trauma centre in Baltimore, USA. PARTICIPANTS: There 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. RESULTS: The 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)). CONCLUSION: In 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.",
keywords = "clinical trials, thromboembolism, trauma management",
author = "{PREVENT CLOT Stakeholder Committee} and O'Hara, {Nathan N.} and Yasmin Degani and Debra Marvel and David Wells and Mullins, {C. Daniel} and Wegener, {Stephen T} and Katherine Frey and Tara Joseph and Jonathan Hurst and Castillo, {Renan Carlos} and O'Toole, {Robert V.}",
year = "2019",
month = "10",
day = "11",
doi = "10.1136/bmjopen-2019-032631",
language = "English (US)",
volume = "9",
pages = "e032631",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "10",

}

TY - JOUR

T1 - Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis

AU - PREVENT CLOT Stakeholder Committee

AU - O'Hara, Nathan N.

AU - Degani, Yasmin

AU - Marvel, Debra

AU - Wells, David

AU - Mullins, C. Daniel

AU - Wegener, Stephen T

AU - Frey, Katherine

AU - Joseph, Tara

AU - Hurst, Jonathan

AU - Castillo, Renan Carlos

AU - O'Toole, Robert V.

PY - 2019/10/11

Y1 - 2019/10/11

N2 - OBJECTIVE: The 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. DESIGN: A retrospective observational study performed from April 2017 to March 2018. SETTING: Academic trauma centre in Baltimore, USA. PARTICIPANTS: There 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. RESULTS: The 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)). CONCLUSION: In 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.

AB - OBJECTIVE: The 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. DESIGN: A retrospective observational study performed from April 2017 to March 2018. SETTING: Academic trauma centre in Baltimore, USA. PARTICIPANTS: There 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. RESULTS: The 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)). CONCLUSION: In 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.

KW - clinical trials

KW - thromboembolism

KW - trauma management

UR - http://www.scopus.com/inward/record.url?scp=85073154364&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073154364&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-032631

DO - 10.1136/bmjopen-2019-032631

M3 - Article

C2 - 31604788

AN - SCOPUS:85073154364

VL - 9

SP - e032631

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

ER -