Background Successful stroke trials require adequate recruitment. In this observational study, we assessed reasons for refusal to provide informed consent in eligible patients approached for clinical trial participation at the Vancouver Stroke Program. Methods We assessed screening logs from four trials that were actively recruiting at our center: three randomized trials, two of which investigated different antithrombotic strategies for secondary prevention (NAVIGATE-ESUS, NCT02313909 12/2014; DATAS-II, NCT02295826 11/2014) and one that investigated surgery plus medical management versus medical management alone for primary prevention (CREST-2, NCT02089217 03/2014). The fourth study was observational and non-randomized; all participants received an external monitoring device (PROPHECY, NCT03712865 10/2018). Screening logs from June 2015 to April 2017 were reviewed retrospectively. Subsequently, we used a prospective structured case report form for screening (May 2017–March 2018). We assessed and compared refusal rates between trials, demographics of those refusing consent, and their reasons for doing so. We used descriptive statistics, chi-square and Fisher’s exact tests as appropriate for non-parametric data, and t-tests for parametric data. We examined likelihood of refusal by sex using multivariable logistic regression models including age and trial intervention as co-variables. Results A total of 235 patients (43% women) were approached for consent. More patients refused the surgical (59%) and antithrombotic trials (53%) compared with the non-randomized external monitoring device study (13%) ( p < 0.001). Surgical trial refusals were primarily due to a desire for certainty in receiving a particular intervention (39%), with the majority of those patients wanting surgery. Refusals for the antithrombotic trials were mainly due to concerns with the potential side effects of the study drug (41%); refusals in the device trial were mainly due to disinterest (46%). Women refused participation more often than men (48% vs 33%). Women remained less likely to consent than men, even after adjustment for age and trial intervention (OR 0.46, 95% CI 0.26–0.82, p = 0.009). Conclusions Concern surrounding drug safety, randomization, and disinterest were the chief deterrents to enrolment; there were also differences in rates of consent by gender. A better understanding of why patients refuse participation in stroke trials may help to develop future patient-directed communication strategies to improve enrolment. Further research is required to better understand the reasons underlying gender disparities in consent rates. Electronic supplementary material The online version of this article (10.1186/s13063-019-3434-0) contains supplementary material, which is available to authorized users.
Background: The Montreal Cognitive Assessment (MoCA) is a commonly used cognitive outcome in stroke trials. However, it may be insufficiently sensitive to detect impairment in high-functioning stroke survivors. The National Institutes of Health (NIH) Toolbox Cognition Battery (NIHTB-CB), a 30-min comprehensive tablet-based cognitive assessment, may be a better choice to characterize cognitive issues in this cohort. Methods: We compared MoCA and NIHTB-CB performance in young stroke survivors (18–55 years) with excellent functional outcomes (modified Rankin Scale 0–1) reporting subjective cognitive complaints to that of age-matched healthy controls. We recruited 53 stroke survivors and 53 controls. We performed a sensitivity analysis in those participants with normal MoCA scores (≥26). Results: Median MoCA scores were not significantly different between stroke survivors (27.0 vs. 28.0) and healthy controls. Mean T scores for NIHTB-CB fluid (44.9 vs. 54.2), crystallized (53.8 vs. 60.0), and total cognition (49.1 vs. 58.4) components were significantly lower in stroke survivors compared to healthy controls (p < 0.001 for all). In participants scoring within normal range (≥26) on the MoCA, NIHTB-CB scores for all components remained significantly lower in stroke survivors. Conclusions: In young stroke survivors with excellent functional outcomes and subjective cognitive complaints, the NIHTB-CB, but not the MoCA, was able to detect differences in cognitive performance between stroke survivors and healthy controls. The NIHTB-CB may be a suitable outcome measure for cognition in clinical trials examining higher-functioning young stroke survivors.
Our novel videoconference protocol for the NIHTB-CB is equivalent to the standard protocol in healthy participants, and may provide a solution for researchers seeking to engage study participants at remote sites. If the NIHTB-CB is used longitudinally to monitor patients, corrections for repeated measures may be required.
The National Institutes of Health Toolbox-Cognition Battery (NIHTB-CB) is a tablet-based cognitive assessment intended for individuals with neurological diseases of all ages. NIHTB-CB practice effects (PEs), however, need clarification if this measure is used to track longitudinal change. We explored the test–retest PEs on NIHTB-CB performance at 3 months in young healthy adults (n = 22). We examined corrected T-scores normalized for demographic factors and calculated PEs using Cohen’s d. There were significant PEs for all NIHTB-CB composite scores and on 4/7 subtests. This work suggests the need to further assess NIHTB-CB PEs as this may affect the interpretation of study results incorporating this battery.
Introduction: Current Canadian and US guidelines recommend screening for post-stroke cognitive impairment using the Montreal Cognitive Assessment (MoCA), and this metric is often used to assess cognition in stroke trials. The MoCA, however, may lack sensitivity to detect cognitive impairment in young, high-functioning patients with subtle cognitive deficits. We compared differences in performance between the NIH Toolbox-Cognition Battery (NIHTB-CB, an iPad-based 30-minute test that normalizes scores for age, sex, education and ethnicity), and the MoCA in young (18-55 years old), high-functioning (mRS 0-1) people with stroke and age-matched healthy controls. Methods: Recruitment for a target sample size of 120 is ongoing. To date, 21 healthy controls and 21 post-stroke participants are enrolled. Group differences in MoCA, NIHTB-CB fluid cognition, NIHTB-CB crystalized cognition and NIHTB-CB total cognition composite scores were compared using independent t-tests. Effect size of mean differences were calculated using Cohen’s d. The health utility of each group was measured with the EQ-5D. Results: Only the NIHTB-CB fluid cognition and total cognition scores were significantly worse for stroke patients compared to healthy controls, although there was a trend towards lower scores for the NIHTB-CB crystalized cognition and MoCA in the post-stroke group (Table). Stroke patients were 5.3 ± 5.6 months post-stroke. EQ-5D scores were lower for the post-stroke group, indicating worse health status. Conclusions: Our preliminary findings suggest that the NIHTB-CB may be a time-efficient alternative to the MoCA. The NIHTB-CB fluid and total cognition composite scores appear better suited than the MoCA for investigating cognitive impairments in young, mildly disabled stroke patients.
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