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教育干预对多发性硬化症专家神经科医生治疗惰性的影响:一项随机临床试验。

Effect of an Educational Intervention on Therapeutic Inertia in Neurologists With Expertise in Multiple Sclerosis: A Randomized Clinical Trial.

机构信息

Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.

出版信息

JAMA Netw Open. 2020 Dec 1;3(12):e2022227. doi: 10.1001/jamanetworkopen.2020.22227.

Abstract

IMPORTANCE

Therapeutic inertia (TI) is the failure to escalate therapy when treatment goals are unmet and is associated with low tolerance to uncertainty and aversion to ambiguity in physician decision-making. Limited information is available on how physicians handle therapeutic decision-making in the context of uncertainty.

OBJECTIVE

To evaluate whether an educational intervention decreases TI by reducing autonomic arousal response (pupil dilation), a proxy measure of how physicians respond to uncertainty during treatment decisions.

DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 34 neurologists with expertise in multiple sclerosis (MS) practicing at 15 outpatient MS clinics in academic and community institutions from across Canada were enrolled. Participants were randomly assigned to receive an educational intervention that facilitates treatment decisions (active group) or to receive no exposure to the intervention (usual care [control group]) from December 2017 to March 2018. Participants listened to 20 audio-recorded simulated case scenarios as pupil responses were assessed by eye trackers. Autonomic arousal was assessed as pupil dilation in periods in which critical information was provided (first period [T1]: clinical data, second period [T2]: neurologic status, and third period [T3]: magnetic resonance imaging data). Data were analyzed from September 2018 to March 2020.

INTERVENTIONS

The traffic light system (TLS)-based educational intervention vs usual care (unexposed). The TLS (use of established associations between traffic light colors and actions to stop or proceed) assists participants in identifying factors associated with worse prognosis in MS care, thereby facilitating the treatment decision-making process by use of established associations between red, green, and yellow colors and risk levels, and actions (treatment decisions).

MAIN OUTCOMES AND MEASURES

Pupil assessment was the primary autonomic outcome. To test the treatment effect of the educational intervention (TLS), difference-in-differences models (also called untreated control group design with pretest and posttest) were used.

RESULTS

Of 38 eligible participants, 34 (89.4%) neurologists completed the study. The mean (SD) age was 44.6 (11.6) years; 38.3% were female and 20 (58.8%) were MS specialists. Therapeutic inertia was present in 50.0% (17 of 34) of all participants and was associated with greater pupil dilation. For every additional SD of pupil dilation, the odds of TI increased by 51% for T1 (odds ratio, 1.51; 95% CI, 1.12-2.03), by 31% for T2 (odds ratio, 1.31; 95% CI, 1.08-1.59), and by 49% for T3 (odds ratio, 1.49; 95% CI, 1.13-1.97). The intervention significantly reduced TI (risk reduction, 31.5%; 95% CI, 16.1%-47.0%). Autonomic arousal responses mediated 29.0% of the effect of the educational intervention on TI.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, the TLS intervention decreased TI as measured by pupil dilation, which suggests that individual autonomic arousal is an indicator of how physicians handle uncertainty when making live therapeutic decisions. Pupil response, a biomarker of TI, may eventually be useful in medical education.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03134794.

摘要

重要性:治疗惰性(TI)是指在未达到治疗目标时未能升级治疗,与医生在决策中对不确定性的容忍度低和对模糊性的厌恶有关。关于医生在不确定情况下如何处理治疗决策,可用的信息有限。

目的:评估教育干预是否通过减少自主反应(瞳孔扩张)来减少 TI,这是衡量医生在治疗决策中对不确定性反应的一种替代指标。

设计、设置和参与者:在这项随机临床试验中,纳入了来自加拿大各地 15 家学术和社区医疗机构的 34 名具有多发性硬化症(MS)专业知识的神经科医生。参与者被随机分配接受促进治疗决策的教育干预(实验组)或不接受干预(对照组),从 2017 年 12 月至 2018 年 3 月。参与者听取了 20 个音频模拟病例情景,同时通过眼动追踪器评估自主反应。自主反应评估为瞳孔在提供关键信息期间的扩张(第一期[T1]:临床数据,第二期[T2]:神经状态,第三期[T3]:磁共振成像数据)。数据分析于 2018 年 9 月至 2020 年 3 月进行。

干预措施:基于红绿灯系统(TLS)的教育干预与常规护理(未暴露)。TLS(使用红绿灯颜色与停止或继续行动之间的既定关联)帮助参与者识别与 MS 护理预后较差相关的因素,从而通过使用红绿灯颜色与风险水平和行动(治疗决策)之间的既定关联,促进治疗决策过程。

主要结果和措施:瞳孔评估是主要的自主反应结果。为了测试教育干预(TLS)的治疗效果,使用了差异-差异模型(也称为有前测和后测的未处理对照组设计)。

结果:在 38 名符合条件的参与者中,有 34 名(89.4%)神经科医生完成了研究。平均(标准差)年龄为 44.6(11.6)岁;38.3%为女性,20 名(58.8%)为多发性硬化症专家。50.0%(34 名参与者中的 17 名)的所有参与者均存在治疗惰性,且与更大的瞳孔扩张有关。对于瞳孔扩张每增加一个标准差,T1 时 TI 的可能性增加 51%(优势比,1.51;95%置信区间,1.12-2.03),T2 时增加 31%(优势比,1.31;95%置信区间,1.08-1.59),T3 时增加 49%(优势比,1.49;95%置信区间,1.13-1.97)。该干预显著降低了 TI(风险降低,31.5%;95%置信区间,16.1%-47.0%)。自主反应对教育干预对 TI 的影响的中介作用为 29.0%。

结论和相关性:在这项随机临床试验中,TLS 干预通过瞳孔扩张减少了 TI,这表明个体自主反应是医生在进行实时治疗决策时处理不确定性的指标。瞳孔反应,即 TI 的生物标志物,最终可能在医学教育中有用。

试验注册:ClinicalTrials.gov 标识符:NCT03134794。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e381/7745101/d32f1496106d/jamanetwopen-e2022227-g001.jpg

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