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Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.
Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.
Acute myocardial infarction (AMI) remains a major cause of death and β-blockers are known to reduce long-term mortality in post-AMI patients. We sought to determine whether patients receiving β-blockers acutely (within 72 h) following AMI had a lower mortality rate at 6 weeks than patients receiving placebo.
We conducted a systematic review of randomized controlled clinical trials that assessed 6-week mortality and compared β-blockers with placebo in patients randomized within the first 72 hours following AMI. We searched these databases: MEDLINE (1966–2006), EMBASE (1980–2007), Cochrane Central Register of Controlled Trials, Health Star (1966–2007), Cochrane Database for Systematic Reviews, ACP Journal Club (1991–2007), Database of Abstracts of Reviews of Effect (< 1st quarter 2007) and Conference Papers Index (1984–2007). Two blinded reviewers extracted the data and rated study quality using the Jadad score and the adequacy of allocation concealment score, which was adopted by the Cochrane group. We calculated pooled odds ratios (ORs) using a random effect model and performed sensitivity analyses to explore the stability of the overall treatment effect.
We included 18 studies (13 were rated high-quality) with 74 643 enrolled participants and had 5095 deaths. Compared with placebo, adding β-blockers to other interventions within 72 hours after AMI did not result in a statistically significant reduction in 6-week mortality (OR 0.95, 95% confidence interval [CI] 0.90–1.01). When restricted to high quality studies, the OR for 6-week mortality reduction was 0.96 (95% CI 0.91–1.02). We found similar results including studies that enrolled patients within 24 hours after AMI. However, a subgroup analysis that excluded high-risk patients with Killip class III and above showed that β-blockers resulted in a significant reduction in short-term mortality (OR 0.93, 95% CI 0.88–0.99).
Acute intervention with β-blockers does not result in a statistically significant short-term survival benefit following AMI but may be beneficial for low-risk (Killip class I) patients.
Buckle fractures are the most common wrist fractures in children, yet there is little literature regarding their management. This study examined the management of these fractures and attitudes toward their immobilization by pediatric emergency department (ED) physicians and pediatric orthopedic surgeons.
A standardized survey was mailed to all pediatric orthopedic surgeons and pediatric ED physicians at 8 Canadian children’s hospitals.
Eighty-seven percent of physicians responded, including 33 of 39 pediatric orthopedic surgeons and 84 of 96 pediatric ED physicians. Sixty-four percent of respondents believe that wrist buckle fractures always need to be immobilized; pain control was most frequently cited for this belief. Physicians who did not believe that all buckle fractures need to be immobilized indicated that these fractures are inherently stable and have a low risk of refracture. Forty-eight percent of the orthopedic surgeons prefer below-elbow casts, 30% prefer a combination (splint and cast) and 12% prefer backslabs. Sixty percent of ED physicians “usually or always” use casts and 31% “usually or always” use backslabs. Although there was variation among the orthopedic surgeons regarding the recommended length of immobilization, most (70%) recommended 2 to 4 weeks, although some (12%) treated only until pain free. ED physicians showed greater diversity regarding length of immobilization.
Although many physicians believe that wrist buckle fractures need to be immobilized, a significant number do not. There is substantial variability in the type and length of immobilization used. This variability suggests that the optimal management strategy for wrist buckle fractures is unclear and should be determined in future prospective studies.
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