PDF(Pubmed)
Abstract：
BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention.
METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy.
RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context.
CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses\' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness.
BACKGROUND: Number NCT02765009.
METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy.
RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context.
CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses\' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness.
BACKGROUND: Number NCT02765009.
摘要：
背景：POINCARE-2试验旨在评估一种旨在通过每日称重和随后的治疗措施解决危重患者体液超负荷的策略的有效性。即使在高度标准化的护理环境中，比如重症监护病房,这种复杂干预措施的有效性取决于其实际有效性，也取决于其实施程度。使用过程评估，我们旨在提供对实施的理解，context,以及试验过程中POINCARE-2策略变化的机制，了解其有效性，并告知有关干预措施传播的决定。
方法：我们遵循医学研究理事会指南进行了混合方法过程评估。这两个定量数据都来自试验，并使用来自与专业人士的半结构化访谈的定性数据来解释实施，POINCARE-2战略的变化机制，以及潜在影响战略实施的环境因素。
结果：在对照期间，该策略的实际暴露分数为29.1％至68.2％，干预期间从61.9%上升到92.3%，表明了潜在的污染和对策略的次优保真度。缺乏适当的称重装置，缺乏专门用于研究的人力资源，审判前根深蒂固的处方习惯，和预期的战略知识已被确定为在试验背景下最佳实施战略的主要障碍。
结论：POINCARE-2策略的污染和次优保真度都引起了人们对意向治疗（ITT）分析无效的潜在偏见的担忧。然而,最佳保真度似乎是可以实现的。因此,临床策略不应仅基于ITT分析的阴性结果而被拒绝.我们的研究结果表明,即使在高度标准化的护理条件下，临床策略的实施可能受到许多环境因素的阻碍，这表明了评估干预措施可行性的至关重要性，在对其有效性进行任何评估之前。
背景：编号NCT02765009。
方法：我们遵循医学研究理事会指南进行了混合方法过程评估。这两个定量数据都来自试验，并使用来自与专业人士的半结构化访谈的定性数据来解释实施，POINCARE-2战略的变化机制，以及潜在影响战略实施的环境因素。
结果：在对照期间，该策略的实际暴露分数为29.1％至68.2％，干预期间从61.9%上升到92.3%，表明了潜在的污染和对策略的次优保真度。缺乏适当的称重装置，缺乏专门用于研究的人力资源，审判前根深蒂固的处方习惯，和预期的战略知识已被确定为在试验背景下最佳实施战略的主要障碍。
结论：POINCARE-2策略的污染和次优保真度都引起了人们对意向治疗（ITT）分析无效的潜在偏见的担忧。然而,最佳保真度似乎是可以实现的。因此,临床策略不应仅基于ITT分析的阴性结果而被拒绝.我们的研究结果表明,即使在高度标准化的护理条件下，临床策略的实施可能受到许多环境因素的阻碍，这表明了评估干预措施可行性的至关重要性，在对其有效性进行任何评估之前。
背景：编号NCT02765009。
