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Tool for evaluating research implementation challenges: A sense-making protocol for addressing implementation challenges in complex research settings

机译:评估研究实施挑战的工具:解决复杂研究环境中实施挑战的明智协议

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Background Many challenges arise in complex organizational interventions that threaten research integrity. This article describes a Tool for Evaluating Research Implementation Challenges (TECH), developed using a complexity science framework to assist research teams in assessing and managing these challenges. Methods During the implementation of a multi-site, randomized controlled trial (RCT) of organizational interventions to reduce resident falls in eight nursing homes, we inductively developed, and later codified the TECH. The TECH was developed through processes that emerged from interactions among research team members and nursing home staff participants, including a purposive use of complexity science principles. Results The TECH provided a structure to assess challenges systematically, consider their potential impact on intervention feasibility and fidelity, and determine actions to take. We codified the process into an algorithm that can be adopted or adapted for other research projects. We present selected examples of the use of the TECH that are relevant to many complex interventions. Conclusions Complexity theory provides a useful lens through which research procedures can be developed to address implementation challenges that emerge from complex organizations and research designs. Sense-making is a group process in which diverse members interpret challenges when available information is ambiguous; the groups’ interpretations provide cues for taking action. Sense-making facilitates the creation of safe environments for generating innovative solutions that balance research integrity and practical issues. The challenges encountered during implementation of complex interventions are often unpredictable; however, adoption of a systematic process will allow investigators to address them in a consistent yet flexible manner, protecting fidelity. Research integrity is also protected by allowing for appropriate adaptations to intervention protocols that preserve the feasibility of ‘real world’ interventions.
机译:背景技术复杂的组织干预会威胁到研究的完整性,因此会带来许多挑战。本文介绍了一种使用复杂性科学框架开发的评估研究实施挑战的工具(TECH),以帮助研究团队评估和管理这些挑战。方法在组织干预措施的多站点,随机对照试验(RCT)的实施过程中,我们减少了8个疗养院的住院人数,我们对此进行了归纳开发,然后将其编纂为代码。 TECH是通过研究团队成员与疗养院工作人员之间的互动而产生的过程而开发的,包括有目的地使用复杂性科学原理。结果TECH提供了一种结构,可以系统地评估挑战,考虑其对干预可行性和忠诚度的潜在影响,并确定应采取的行动。我们将该过程编码为一种算法,可以被其他研究项目采用或修改。我们提供了与许多复杂干预措施相关的TECH使用示例。结论结论复杂性理论提供了一个有用的视角,通过它可以开发研究程序来解决复杂组织和研究设计带来的实施挑战。意识制造是一个小组过程,其中当可用信息不明确时,不同成员会解释挑战。小组的解释为采取行动提供了线索。理性思考有助于创造安全的环境,以产生创新的解决方案,从而平衡研究的完整性和实际问题。实施复杂干预措施时遇到的挑战通常是无法预测的;但是,采用系统的流程将使调查人员能够以一致而灵活的方式解决问题,从而保护保真度。允许对干预方案进行适当的修改,以保护“真实”干预的可行性,从而保护研究的完整性。

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