Feasibility of patient recruitment into clinical trials of experimental treatments for acute spinal cord injury

Lee, Robert S.; Noonan, Vanessa K.; Batke, Juliet; Ghag, Arvindera; Paquette, Scott; Boyd, Michael; Fisher, Charles G.; Street, John; Dvorak, Marcel F.

doi:10.1016/j.jocn.2012.02.015

Cited by 28 publications

(29 citation statements)

References 11 publications

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“…In a Canadian primary spinal trauma referral center, a potential 70% enrolment rate of patients with acute traumatic SCI for hypothetical clinical trials was determined. 5 The slightly lower eligibility rate, in comparison with the present study, may be the result of only including patients with traumatic SCI and different exclusion criteria. Naturally, not all eligible patients take part in a study.…”

Section: Discussioncontrasting

confidence: 56%

“…However, the demographic characteristics of the investigated cohort are comparable with the characteristics of acute SCI patients in general, 6,[17][18][19] and the observed study interest and participation rates are in accordance with previously reported data. 5,[10][11][12][13][14][15] The limitations of the present study also include that our investigation is specific to the rehabilitation stage and does not include the first 2 weeks after injury. Patients had been admitted 11 days after SCI, whereas in some SCI centers, the majority of patients are admitted within 48 h after injury.…”

Section: Discussionmentioning

confidence: 97%

“…Patients had been admitted 11 days after SCI, whereas in some SCI centers, the majority of patients are admitted within 48 h after injury. 5 The odds ratio values for age and gender should be interpreted with caution because of the wide CI. Furthermore, it was not possible to investigate the effect of the study design (for example, interventional, observational) on study interest and participation, and there was no outcome variable for assessing patient protection as a result of using the research information flyer.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, primarily eligible patients have to be excluded as a result of severe concomitant injuries (for example, head trauma) or comorbidities, mental disorders, psychoactive substance abuse or communication barriers (for example, foreign languages), which preclude obtaining informed consent or represent confounding factors. 3,5 The reported average number of participants enrolled in SCI trials is larger than 100. 1 Thus, the recruitment of sufficient numbers of acute traumatic and preferably motor complete SCI patients for clinical studies represents a challenge in the light of the relatively low incidence of SCI.…”

Section: Introductionmentioning

confidence: 99%

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Study participation rate of patients with acute spinal cord injury early during rehabilitation

et al. 2015

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Study design: Retrospective observational study. Objectives: To investigate the study participation rate of patients with acute spinal cord injury (SCI) early during rehabilitation after conveying preliminary study information. Setting: Single SCI rehabilitation center in Switzerland. Methods: Newly admitted acute SCI patients receive a flyer to inform them concerning the purpose of clinical research, patient rights and active studies. Upon patient request, detailed study information is given. The rate of patients asking for detailed information (study interest) and the rate of study participation was evaluated from May 2013 to October 2014. Furthermore, the number of patients not withdrawing consent to the utilization of coded health-related data was determined. Results: The flyer was given to 144 of the 183 patients admitted during the observation period. A total of 96 patients (67%) were interested in receiving detailed information, and 71 patients (49%) finally participated in at least one study. The vast majority of patients (that is, 91%) did not withdraw consent for retrospective data analysis. An age over 60 years had a significantly (P ⩽ 0.023) negative effect on study interest and participation, and the consent rate to retrospective data analysis was significantly (Po0.04) lower in patients older than 75 years. Study interest and participation were reduced more than 5 and 14-fold, respectively, in patients older than 60 years. Conclusions: The relatively low (approximately 50%) study participation rates of acute SCI patients should be considered when planning clinical trials. The recruitment of patients older than 60 years may be reduced substantially.

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Section: Discussioncontrasting

confidence: 56%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Study participation rate of patients with acute spinal cord injury early during rehabilitation

et al. 2015

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“…Randomized controlled trials (RCTs) in acute tSCI research are hampered by small sample sizes due to immense recruitment issues 10 ; therefore, large observational cohort studies are likely to play a major role in future tSCI research. It is equally important to ensure balanced representation of confounding variables in observational study cohorts as in RCT's.…”

mentioning

confidence: 99%

Minimizing Errors in Acute Traumatic Spinal Cord Injury Trials by Acknowledging the Heterogeneity of Spinal Cord Anatomy and Injury Severity: An Observational Canadian Cohort Analysis

Dvorak

Noonan

Fallah

et al. 2014

Journal of Neurotrauma

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Clinical trials of therapies for acute traumatic spinal cord injury (tSCI) have failed to convincingly demonstrate efficacy in improving neurologic function. Failing to acknowledge the heterogeneity of these injuries and under-appreciating the impact of the most important baseline prognostic variables likely contributes to this translational failure. Our hypothesis was that neurological level and severity of initial injury (measured by the American Spinal Injury Association Impairment Scale [AIS]) act jointly and are the major determinants of motor recovery. Our objective was to quantify the influence of these variables when considered together on early motor score recovery following acute tSCI. Eight hundred thirty-six participants from the Rick Hansen Spinal Cord Injury Registry were analyzed for motor score improvement from baseline to follow-up. In AIS A, B, and C patients, cervical and thoracic injuries displayed significantly different motor score recovery. AIS A patients with thoracic (T2-T10) and thoracolumbar (T11-L2) injuries had significantly different motor improvement. High (C1-C4) and low (C5-T1) cervical injuries demonstrated differences in upper extremity motor recovery in AIS B, C, and D.A hypothetical clinical trial example demonstrated the benefits of stratifying on neurological level and severity of injury. Clinically meaningful motor score recovery is predictably related to the neurological level of injury and the severity of the baseline neurological impairment. Stratifying clinical trial cohorts using a joint distribution of these two variables will enhance a study's chance of identifying a true treatment effect and minimize the risk of misattributed treatment effects. Clinical studies should stratify participants based on these factors and record the number of participants and their mean baseline motor scores for each category of this joint distribution as part of the reporting of participant characteristics. Improved clinical trial design is a high priority as new therapies and interventions for tSCI emerge.

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Tau Pathology Triggered by Spinal Cord Injury Can Play a Critical Role in the Neurotrauma Development

et al. 2020

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Feasibility of patient recruitment into clinical trials of experimental treatments for acute spinal cord injury

Cited by 28 publications

References 11 publications

Study participation rate of patients with acute spinal cord injury early during rehabilitation

Study participation rate of patients with acute spinal cord injury early during rehabilitation

Minimizing Errors in Acute Traumatic Spinal Cord Injury Trials by Acknowledging the Heterogeneity of Spinal Cord Anatomy and Injury Severity: An Observational Canadian Cohort Analysis

Tau Pathology Triggered by Spinal Cord Injury Can Play a Critical Role in the Neurotrauma Development

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