首页> 外文期刊>Frontiers in Neurology >Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education
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Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education

机译:在多发性硬化症治疗中克服治疗惯性:在医学教育中应用交通信号灯系统的先导随机试验

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Background Physicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI). Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI. Objectives To evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS). Methods We conducted a pilot double-blind, parallel-group, randomized clinical trial. Inclusion criteria included neurologists who are actively involved in managing MS patients. Participants were exposed to 20 simulated case-scenarios (10 cases at baseline, and 10 cases post-randomization to usual care vs. educational intervention) of relapsing–remitting MS with moderate or high risk of disease progression. The educational intervention employed a traffic light system (TLS) to facilitate decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. We also measured differences between blocks to invoke decision fatigue. The control group responded as they would do in their usual clinical practice not exposed to the educational intervention. The primary feasibility outcome was the proportion of participants who completed the study and the proportion of participants who correctly identified a high-risk case-scenario with the “red traffic light.” Secondary outcomes included decision fatigue (defined as an increment of TI in the second block of case-scenarios compared to the first block) and the efficacy of the educational intervention measured as a reduction in TI for MS treatment. Results Of 30 neurologists invited to be part of the study, the participation rate was 83.3% ( n ?=?25). Of the 25 participants, 14 were randomly assigned to the control group and 11 to the intervention group. TI was present in 72.0% of participants in at least one case scenario. For the primary feasibility outcome, the completion rate of the study was 100% (25/25 participants). Overall, 77.4% of participants correctly identified the “red traffic light” for clinical-scenarios with high risk of disease progression. Similarly, 86.4% of participants correctly identified the “yellow traffic light” for cases that would require a reassessment within 6–12?months. For the secondary fatigue outcome, within-group analysis showed a significant increased prevalence of TI in the second block of case-scenarios (decision fatigue) among participants randomized to the control group (TI pre-intervention 57.1% vs. TI post-intervention 71.4%; p ?=?0.015), but not in the active group (TI pre-intervention 54.6% vs. TI post-intervention 63.6%; p ?=?0.14). For the efficacy outcome, we found a non-significant reduction in TI for the targeted intervention compared to controls (22.6 vs. 33.9% post-intervention; OR 0.57; 95% CI 0.26–1.22). Conclusion An educational intervention applying the TLS is feasible and shows some promising results in the identification of high-risk scenarios to reduce decision fatigue and TI. Larger studies are needed to determine the efficacy of the proposed educational intervention. Clinical Trial Registration www.ClinicalTrials.gov , identifier NCT03134794.
机译:背景技术在明确需要时,医师通常不会启动或加强治疗,这种现象被称为治疗惯性(TI)。关于教育干预措施以改善TI中知识与行动之间的差距的信息有限。目的评价在护理多发性硬化症(MS)的实践神经科医生中,与常规护理相比,教育干预的可行性和有效性。方法我们进行了一项试验性双盲,平行组,随机临床试验。纳入标准包括积极参与MS患者管理的神经科医生。参与者暴露于20种模拟病例情境(基线时10例,随机分配至常规护理与教育干预后的10例),复发性MS患有中度或高度疾病进展风险。该教育干预措施采用了交通信号灯系统(TLS)来辅助决策,使参与者能够轻松识别需要治疗升级的高危情况。我们还测量了块之间的差异以调用决策疲劳。对照组的反应与他们通常的临床实践一样,没有受到教育干预。主要的可行性结果是完成研究的参与者的比例,以及通过“红色交通信号灯”正确识别高风险案例的参与者的比例。次要结果包括决策疲劳(定义为病例情境中第二阶段与第一阶段相比TI的增加)和教育干预措施的有效性(衡量MS治疗中TI的减少)。结果30名被邀请参加该研究的神经病学家的参与率为83.3%(n = 25)。在25名参与者中,有14名被随机分配到对照组,而11名被随机分配到干预组。在至少一种情况下,TI占参与者的72.0%。对于主要的可行性结果,研究的完成率为100%(参与者为25/25)。总体而言,有77.4%的参与者正确识别了具有较高疾病发展风险的临床情况的“红色交通灯”。同样,86.4%的参与者正确识别了需要在6-12个月内重新评估的情况的“黄色交通信号灯”。对于继发性疲劳结果,组内分析显示,在随机分为对照组的参与者中,第二种情况(决策疲劳)中TI的患病率显着增加(TI干预前为57.1%,TI干预后为71.4%) %;p≤0.015),但在活动组中没有(TI干预前为54.6%,而TI干预后为63.6%;p≤0.14)。对于疗效结果,我们发现针对性干预的TI与对照组相比无显着降低(干预后22.6 vs. 33.9%; OR 0.57; 95%CI 0.26-1.22)。结论应用TLS的教育干预是可行的,并且在识别高风险场景以减少决策疲劳和TI方面显示出一些有希望的结果。需要进行更大的研究才能确定所提议的教育干预措施的有效性。临床试验注册www.ClinicalTrials.gov,标识符NCT03134794。

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