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随机前瞻性试验,旨在检测和区分慢性心脏代谢疾病中的药物不依从、药物相互作用和疾病进展。

Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease.

机构信息

QURE Healthcare, San Francisco, CA, USA.

University of California, San Francisco, CA, USA.

出版信息

BMC Prim Care. 2023 Apr 15;24(1):100. doi: 10.1186/s12875-023-02042-4.

DOI:10.1186/s12875-023-02042-4
PMID:37061690
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10105436/
Abstract

BACKGROUND

Disentangling nonadherence (NA), drug-drug interactions (DDIs), and disease progression from each other is an important clinical challenge for providers caring for patients with cardiometabolic diseases. NAs and DDIs are both ubiquitous and often overlooked. We studied a novel chronic disease management (CDM) test to detect medication adherence and the presence and severity of DDIs.

MATERIALS AND METHODS

We conducted a prospective, randomized controlled trial of 236 primary care physicians using computer-based, simulated patients, measuring clinical care with and without access to the CDM test. The primary outcomes were whether use of the CDM test increased the accuracy of diagnoses and ordering better treatments and how effective the intervention materials were in getting participants to order the CDM test.

RESULTS

Physicians given the CDM test results showed a + 13.2% improvement in their diagnosis and treatment quality-of-care scores (p < 0.001) in the NA patient cases and a + 13.6% improvement in the DDI cases (p < 0.001). The difference-in-difference calculations between the intervention and control groups were + 10.4% for NA and + 10.8% for DDI (p < 0.01 for both). After controlling for physician and practice co-factors, intervention, compared to control, was 50.4x more likely to recognize medication NA and 3.3x more likely to correctly treat it. Intervention was 26.9x more likely to identify the DDI and 15.7x more likely to stop/switch the interacting medication compared to control. We found no significant improvements for the disease progression patient cases.

CONCLUSION

Distinguishing between nonadherence, drug-drug interactions, and disease progression is greatly improved using a reliable test, like the CDM test; improved diagnostic accuracy and treatment has the potential to improve patient quality of life, medication safety, clinical outcomes, and efficiency of health delivery.

TRIAL REGISTRATION

clinicaltrials.gov (NCT05192590).

摘要

背景

对于治疗心血管代谢疾病的临床医生来说,区分不依从(NA)、药物-药物相互作用(DDI)和疾病进展是一项重要的临床挑战。NA 和 DDI 都是普遍存在且经常被忽视的。我们研究了一种新型的慢性病管理(CDM)测试,以检测药物依从性以及 DDI 的存在和严重程度。

材料和方法

我们对 236 名初级保健医生进行了一项前瞻性、随机对照试验,使用基于计算机的模拟患者,在使用和不使用 CDM 测试的情况下衡量临床护理。主要结果是使用 CDM 测试是否提高了诊断和治疗质量的准确性,以及干预材料在促使参与者订购 CDM 测试方面的有效性。

结果

使用 CDM 测试结果的医生在 NA 患者病例中的诊断和治疗质量评分提高了 13.2%(p<0.001),在 DDI 病例中的提高了 13.6%(p<0.001)。干预组和对照组之间的差值计算结果为 NA 病例中+10.4%,DDI 病例中+10.8%(均 p<0.01)。在控制医生和实践协变量后,与对照组相比,干预组识别药物 NA 的可能性高 50.4 倍,正确治疗的可能性高 3.3 倍。与对照组相比,干预组识别 DDI 的可能性高 26.9 倍,停止/更换相互作用药物的可能性高 15.7 倍。我们没有发现疾病进展患者病例的显著改善。

结论

使用可靠的测试(如 CDM 测试)可以大大提高区分不依从、药物-药物相互作用和疾病进展的能力;提高诊断准确性和治疗效果有可能提高患者的生活质量、药物安全性、临床结果和医疗服务效率。

试验注册

clinicaltrials.gov(NCT05192590)。

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