实用临床试验

Pragmatic Clinical Trials 

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The traditional approach in nursing science is to focus on research from randomized controlled trials (RCTs). RCT research design is scientifically robust, readily accepted, and historically verified. However, RCT research is also slow and expensive and rarely produces findings that are easily put into practice. Traditional RCTs study the effects of treatments delivered to carefully selected populations under ideal conditions. As RCTs rarely happen in typical clinical settings, the findings are often not feasible for real-world uptake. This makes it difficult to translate results into everyday clinical practice. Thus, if we limit nursing research strictly to this approach, we will see significant limitations to our ability to rapidly influence nursing practice. If we want more evidence-based practice in nursing, we need more nursing practice-based research evidence.

One way to ensure that research results can be translated into effective practice guidelines that will be accepted and implemented in routine clinical care is to conduct pragmatic clinical trials (PCTs). PCTs are designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens, and risks of an intervention [1]. The purpose of this editorial is to briefly describe key characteristics of PCTs and advocate the increased use of PCTs in nursing research.

Some of the key characteristics of PCTs are that they (1) are designed to improve practice; (2) utilize key stakeholder input from multiple levels, such as patients, providers, administrators; and (3) are conducted in settings where everyday care happens. A PCT is more practical because it is designed to identify interventions that can achieve success in realistic, typical, functioning health care settings. Specifically, PCT research design (1) has broad inclusion and few exclusion criteria, enhancing the generalizability of findings; (2) engages health care providers integral to the setting but who may have little research experience, such as practicing nurses, in delivering the interventions; (3) delivers interventions in a way similar to usual care and incorporates them into a typical health care workflow; and (4) collects data in the context of routine clinical care, usually from the electronic health care records [2].

PCTs are not an abandonment of the scientific methods of RCTs. No clinical trial is completely explanatory (RCT) or pragmatic (PCT). RCTs and PCTs exist on a continuum and focus on different questions (e.g. ‘Can an intervention work under ideal conditions?’ or ‘Does an intervention work under usual conditions?’). To assist nursing researchers with determining if their study is more RCT or PCT, the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2 Tool) can be used to assess a research study across nine domains: eligibility, recruitment, setting, organization, flexibility in intervention delivery, flexibility in intervention adherence, follow-up, primary outcomes, and primary analysis [3, 4]. By using the PRECIS-2 nurse researchers can determine the approach along the explanatory-pragmatic continuum that is most appropriate for answering their research question. As no trial is completely explanatory or pragmatic, nurse researchers can also ask themselves how their research can adapt to be more pragmatic.

While RCT design is scientifically robust, readily accepted, and historically verified, limiting ourselves too strictly to this approach will result in significant limitations to our collective progress. Using PCT principles to design nursing research studies generates results that are more actionable, patient-centered, and relevant. PCT research output is actionable because it is designed around pragmatic and realistic clinical settings and is focused on implementation. A PCT’s alignment of goals and measures around individuals’ goals of care and its pragmatic adaptation to non-response to interventions ensure a patient-centered process and results. The PCT data and results, along with adherence to practical settings and goals, produce results that are understandable, relatable, and relevant to health care decision-makers and policy proponents.

Given that, it is important that we nurses advance those techniques that most closely connect our scientific thinking with our clinical activity. Embracing and increasing our use of PCT design concepts in nursing research can support this connection. By doing this, we enhance the significance of our findings, the ease of translating our research into practice, and our ability to continually improve outcomes for all.

全文翻译（仅供参考）

护理科学的传统方法是注重随机对照试验的研究随机对照试验的研究设计在科学上是可靠的，容易被接受，并且经过历史验证。随机对照试验研究也是缓慢和昂贵的，很少产生容易付诸实践的发现。传统的随机对照试验研究的是在理想条件下对精心挑选的人群进行治疗的效果。由于随机对照试验很少发生在典型的临床环境中，研究结果通常不适用于现实世界。这使得很难将结果转化为日常临床实践。因此，如果我们严格限制护理研究的这种方法，我们将看到我们迅速影响护理实践的能力受到重大限制。如果我们希望在护理中有更多的循证实践，我们需要更多基于护理实践的研究证据。

确保研究结果能够转化为有效的实践指南，并在常规临床护理中被接受和实施的一种方法是进行实用的临床试验（PCTs）。PCTs的主要目的是向决策者提供有关干预的收益、负担和风险的比较平衡的信息。1这篇社论的目的是简要描述PCTs的关键特征，并倡导在护理研究中增加PCTs的使用。

PCT的一些关键特征是：（1）旨在改进实践;（2）利用来自多个层面的关键利益相关者输入，例如患者、提供者、管理者;和（3）在日常护理的环境中进行。PCT更实用，因为它旨在确定在现实、典型、功能正常的卫生保健环境中能够取得成功的干预措施。具体而言，PCT研究设计（1）具有广泛的纳入标准和很少的排除标准，增强了结果的普遍性;（2）让环境中不可或缺但可能缺乏研究经验的卫生保健提供者（如执业护士）参与实施干预措施;（3）以类似于常规护理的方式提供干预，并将其纳入典型的卫生保健工作流程;以及（4）在常规临床护理的背景下通常从电子健康护理记录收集数据[2].

PCTs并不是放弃RCT的科学方法，没有一个临床试验是完全可以解释的（RCT）或务实RCT和PCT是一个连续体，关注不同的问题（例如："干预措施在理想条件下是否有效？“或”干预措施在通常条件下是否有效？“）为了帮助护理研究人员确定其研究是否更多是RCT或PCT，PRagmatic解释连续体指标摘要（PRECIS-2工具）可用于评估跨越九个领域的研究：资格、招募、设置、组织、干预实施的灵活性、干预依从性的灵活性、随访、主要结局和主要分析[3，4]。透过PRECIS-2，护理研究人员可在解释性与实用性的连续统一体沿着，决定最适合回答研究问题的方法。由于没有试验是完全解释性或实用性的，护理研究人员也可自问如何使研究更实用。

虽然RCT设计在科学上是稳健的，容易接受的，并且经过历史验证，但过于严格地限制我们自己将导致我们集体进步的重大限制。使用PCT原则设计护理研究会产生更可操作的，以患者为中心的，PCT研究成果是可操作的，因为它是围绕务实和现实的临床环境设计的，并专注于实施。PCT围绕个人护理目标调整目标和措施，并务实地适应干预措施无反应，确保了以患者为中心的过程和结果。PCT数据和结果，以及对实际设置和目标的坚持，产生了卫生保健决策者和政策支持者可以理解、相关和相关的结果。

鉴于此，我们护士推进那些将我们的科学思维与临床活动最紧密地联系起来的技术是很重要的。在护理研究中接受并更多地使用PCT设计概念可以支持这种联系。通过这样做，我们提高了我们发现的意义，将我们的研究转化为实践的容易程度，以及我们持续改善所有人结局的能力。

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