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患者在急诊部门等待的时间越长,是否越不愿意同意参与研究?

Are patients with longer emergency department wait times less likely to consent to research?

机构信息

Division of Emergency Medicine, Department of Surgery, Duke University Medical Center, Durham, NC, USA.

出版信息

Acad Emerg Med. 2012 Apr;19(4):396-401. doi: 10.1111/j.1553-2712.2012.01310.x.

Abstract

OBJECTIVES

There are unique challenges to enrolling patients in emergency department (ED) clinical research studies, including the time-sensitive nature of emergency conditions, the acute care environment, and the lack of an established relationship with patients. Prolonged ED wait times have been associated with a variety of adverse effects on patient care. The objective of this study was to assess the effect of ED wait times on patient participation in ED clinical research. The hypothesis was that increased ED wait times would be associated with reduced ED clinical research consent rates.

METHODS

This was a retrospective cohort study of all patients eligible for two diagnostic clinical research studies from January 1, 2008, through December 31, 2008, in an urban academic ED. Sex, age, race, study eligibility, and research consent decisions were recorded by trained study personnel. The wait times to registration and to be seen by a physician were obtained from administrative databases and compared between consenters and nonconsenters. An analysis of association between patient wait times for the outcome of consent to participate was performed using a multivariate logistic regression model.

RESULTS

A total of 903 patients were eligible for enrollment and were asked for consent. Overall, 589 eligible patients (65%) gave consent to research participation. The consent rates did not change when patients were stratified by the highest and lowest quartile wait times for both time from arrival to registration (68% vs. 65%, p = 0.35) and time to be seen by a physician (65% vs. 66%, p = 0.58). After adjusting for patient demographics (age, race, and sex) and study, there was still no relationship between wait times and consent (p > 0.4 for both wait times). Furthermore, median time from arrival to registration did not differ between those who consented to participate (15 minutes; interquartile range [IQR] = 9 to 36 minutes) versus those who did not (15.5 minutes; IQR = 10 to 39 minutes; p = 0.80; odds ratio [OR] = 1.00, 95% confidence interval [CI] = 0.99 to 1.01). Similarly, there was no difference in the median time to be seen by a physician between those who consented (25 minutes; IQR = 15 to 55 minutes) versus those who did not (25 minutes; IQR = 15 to 56 minutes; p = 0.70; OR = 1.00, 95% CI = 0.99 to 1.01).

CONCLUSIONS

Regardless of wait times, nearly two-thirds of eligible patients were willing to consent to diagnostic research studies in the ED. These findings suggest that effective enrollment in clinical research is possible in the ED, despite challenges with prolonged wait times.

摘要

目的

在急诊科(ED)临床研究中招募患者存在独特的挑战,包括紧急情况的时间敏感性、急性护理环境以及与患者缺乏既定关系。ED 等待时间延长与患者护理的各种不良后果有关。本研究的目的是评估 ED 等待时间对患者参与 ED 临床研究的影响。假设是增加 ED 等待时间与 ED 临床研究同意率降低有关。

方法

这是一项回顾性队列研究,纳入了 2008 年 1 月 1 日至 2008 年 12 月 31 日期间在城市学术 ED 中符合两项诊断性临床研究条件的所有患者。通过经过培训的研究人员记录性别、年龄、种族、研究资格和研究同意决定。从行政数据库中获取登记和就诊医师的等待时间,并在同意者和不同意者之间进行比较。使用多变量逻辑回归模型分析同意参与的患者等待时间与结果之间的关联。

结果

共有 903 名患者符合入组条件并被要求同意。总体而言,589 名符合条件的患者(65%)同意参与研究。当根据到达登记的最高和最低四分位等待时间对患者进行分层时,同意率没有变化(到达登记的时间分别为 68%和 65%,p=0.35;就诊医师的时间分别为 65%和 66%,p=0.58)。在调整了患者人口统计学特征(年龄、种族和性别)和研究后,等待时间与同意之间仍然没有关系(两个等待时间的 p 值均大于 0.4)。此外,到达登记的中位数时间在同意参与的患者(15 分钟;四分位距 [IQR]=9 至 36 分钟)与未同意的患者之间没有差异(15.5 分钟;IQR=10 至 39 分钟;p=0.80;比值比 [OR]=1.00,95%置信区间 [CI]=0.99 至 1.01)。同样,在同意的患者(25 分钟;IQR=15 至 55 分钟)和未同意的患者(25 分钟;IQR=15 至 56 分钟)之间,就诊医师的中位数时间也没有差异(p=0.70;OR=1.00,95%CI=0.99 至 1.01)。

结论

无论等待时间如何,近三分之二的符合条件的患者愿意同意在 ED 进行诊断性研究。这些发现表明,尽管 ED 等待时间延长存在挑战,但在 ED 中进行有效的临床研究入组是可能的。

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