Who says "no" to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program.

Autor: O'Neill ZR; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada., Deptuck HM; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada., Quong L; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada.; Faculty of Medicine, Memorial University, 300 Prince Philip Drive, St. John's, NL, A1B 3V6, Canada., Maclean G; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada., Villaluna K; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada., King-Azote P; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada., Sharma M; Population Health Research Institute, Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.; Faculty of Medicine, McMaster University, 237 Barton St. E., Hamilton, ON, L8L 2X2, Canada., Butcher K; University of New South Wales, Prince of Wales Clinical School, Level 1, South Wing, Edmund Blacket Building Prince of Wales Hospital, Ranwick, NSW, 2031, Australia., Hart RG; Population Health Research Institute, Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada., Field TS; Vancouver Stroke Program - Research Office, 8295-2775 Laurel Street, Vancouver,, BC, V5Z 1M9, Canada. thalia.field@ubc.ca.; Faculty of Medicine, University of British Columbia, S169-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada. thalia.field@ubc.ca.
Jazyk: angličtina
Zdroj: Trials [Trials] 2019 May 31; Vol. 20 (1), pp. 313. Date of Electronic Publication: 2019 May 31.
DOI: 10.1186/s13063-019-3434-0
Abstrakt: 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.
Databáze: MEDLINE
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