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

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 measureThe 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.

How Many Patients Do We Need? Predictors of Consent to Participate in Clinical Research Studies in Orthopaedic Trauma

“…Investigators might also consider the amount of follow-up time required, the burden of data collection, patient incentives, and the amount of time the patient has to decide whether to participate or not. O'Hara et al 3 also found that the specific intervention was related to consent rates, with prophylactic medication regimens having higher refusal rates than surgical interventions.…”

“…Rates of recruitment are infrequently published in the orthopaedic literature; those that are range dramatically from 10% to 92%. In the United States and Canada specifically, the rate of participation 2,3 is lower than other countries (80%) and below 50% when studies are randomizing to an operative versus a nonoperative arm. 2 However, some literature seems to demonstrate that participation in clinical trials is higher among patients with orthopaedic trauma as compared with other subspecialties, with participation above 85%.…”

Study Quality and Patient Inclusion in Geriatric Orthopaedic Trauma Research: A Scoping Review

“…Exclusion criteria were (1). age of participants not specified (with the exception of studies that used age of 65 years or above as an inclusion criterion, these were included even if age of the population was not specified), (2). study population not adequately described to determine eligibility using the inclusion criteria, and (3).…”

“…The inclusion criteria were (1). clinical studies (ie, RCTs, prospective cohort studies including nonrandomized clinical trials, retrospective cohort, cross-sectional, or cohort studies not otherwise specified), (2). studying patients with fracture with a median or mean age of 65 years and above, and (3).…”

“…First, older patients are more likely to refuse participation in clinical studies. 2 Second, older patient populations are prone to selective loss to follow-up and typically have a high mortality rate after fractures. [3][4][5][6][7] Third, randomization for randomized clinical trials (RCTs) is difficult in trauma research.…”