Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e032631.full |
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| author | Nathan N O’Hara Robert V O’Toole Renan Castillo C Daniel Mullins Yasmin Degani Debra Marvel David Wells Stephen Wegener Katherine Frey Tara Joseph Stephen Breazeale Randolph Fenninger Steven Herndon Eileen Flores Stephen Fisher Michelle Medeiros Brianna Fowler |
| author_facet | Nathan N O’Hara Robert V O’Toole Renan Castillo C Daniel Mullins Yasmin Degani Debra Marvel David Wells Stephen Wegener Katherine Frey Tara Joseph Stephen Breazeale Randolph Fenninger Steven Herndon Eileen Flores Stephen Fisher Michelle Medeiros Brianna Fowler |
| author_sort | Nathan N O’Hara |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-39593dc5d09540d38daa64f799dd76a8 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-39593dc5d09540d38daa64f799dd76a82025-08-20T02:39:31ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-032631Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysisNathan N O’Hara0Robert V O’Toole1Renan Castillo2C Daniel Mullins3Yasmin Degani4Debra Marvel5David Wells6Stephen Wegener7Katherine Frey8Tara Joseph9Stephen BreazealeRandolph FenningerSteven HerndonEileen FloresStephen FisherMichelle Medeiros10Brianna Fowler1 Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA1 Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA5 Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA15 PHSR, University of Maryland School of Pharmacy, Baltimore, Maryland, USA1 Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland, USA2 PREVENT CLOT Stakeholder Committee, Baltimore, Maryland, USADiabetes Action Canada, Toronto, Ontario, Canada4 Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA5 Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA5 Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USAPharmaceutical Health Services Research, University of Maryland Baltimore, Baltimore, Maryland, USAObjective 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.https://bmjopen.bmj.com/content/9/10/e032631.full |
| spellingShingle | Nathan N O’Hara Robert V O’Toole Renan Castillo C Daniel Mullins Yasmin Degani Debra Marvel David Wells Stephen Wegener Katherine Frey Tara Joseph Stephen Breazeale Randolph Fenninger Steven Herndon Eileen Flores Stephen Fisher Michelle Medeiros Brianna Fowler Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis BMJ Open |
| title | Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis |
| title_full | Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis |
| title_fullStr | Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis |
| title_full_unstemmed | Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis |
| title_short | Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis |
| title_sort | which orthopaedic trauma patients are likely to refuse to participate in a clinical trial a latent class analysis |
| url | https://bmjopen.bmj.com/content/9/10/e032631.full |
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