Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies.

Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies.
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DOI:
10.1016/j.hjdsi.2020.100432
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发表时间:
2021-06
期刊:
Healthcare (Amsterdam, Netherlands)
影响因子:
--
通讯作者:
Larson EB
Larson EB
中科院分区:
其他
文献类型:
--
作者:
Tuzzio L;Meyers CM;Dember LM;Grudzen CR;Melnick ER;Staman KL;Huang SS;Richards J;DeBar L;Vazquez MA;Green BB;Coronado GD;Jarvik JG;Braciszewski J;Ho PM;Wells BL;James K;Toto R;D'Onofrio G;Volandes A;Kuklinski MR;Catalano RF;Sterling SA;Morse EF;Curtis L;Larson EB

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嵌入式实用临床试验(ePCT)和质量改进(QI)活动通常同时发生在医疗保健系统(HCS)中。在HCS中嵌入PCTs是为了测试干预措施,并提供可能影响公共卫生,卫生系统运作和护理质量的证据。它们比QI计划更大,更广泛地推广,并可能产生被认为是高质量的证据,用于护理和临床实践指南的潜在用途。QI计划通常与ePCT同时发生,并解决相同的高影响健康问题,这种同时发生可能会削弱或混淆检测ePCT干预导致的变化的能力。在大规模NIH合作实验室示范ePCT的设计、试点和实施阶段,许多QI倡议同时发生在HCS内。虽然各个项目面临的挑战各不相同,但出现了一些共同的、可推广的战略和解决方案,我们将其作为案例研究与大家分享。研究团队通常需要在设计和试验过程中监测、调整和响应QI。在整个试验过程中,ePCT研究人员和卫生系统利益相关者之间的常规合作可以帮助确保研究和QI最佳结合,以支持高质量的以患者为中心的护理。
Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality of care. They are larger and more broadly generalizable than QI initiatives, and may generate what is considered high-quality evidence for potential use in care and clinical practice guidelines. QI initiatives often co-occur with ePCTs and address the same high-impact health questions, and this co-occurrence may dilute or confound the ability to detect change as a result of the ePCT intervention. During the design, pilot, and conduct phases of the large-scale NIH Collaboratory Demonstration ePCTs, many QI initiatives occurred at the same time within the HCSs. Although the challenges varied across the projects, some common, generalizable strategies and solutions emerged, and we share these as case studies. Study teams often need to monitor, adapt, and respond to QI during design and the course of the trial. Routine collaboration between ePCT researchers and health systems stakeholders throughout the trial can help ensure research and QI are optimally aligned to support high-quality patient-centered care.
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